Chemicals that pervade our modern world – plastics, pesticides, stain repellents, components of personal hygiene products – are contributing to a decades-long decline in fertility and could pose health risks even into future generations, according to an explosive new book by Shanna Swan, PhD, an environmental and reproductive epidemiologist at the Icahn School of Medicine at Mount Sinai, New York.

Dr. Swan laid out the case that endocrine-disrupting chemicals (EDCs) such as phthalates and bisphenol A (BPA) threaten human existence, a conclusion that stems in part from her 2017 meta-analysis that showed a 52% drop in sperm counts from 1973 to 2011 in men in North America, Europe, and Australia.

“This alarming rate of decline could mean the human race will be unable to reproduce itself if the trend continues,” Dr. Swan said in her book, “Count Down: How Our Modern World Is Threatening Sperm Counts, Altering Male and Female Reproductive Development, and Imperiling the Future of the Human Race,” (New York: Scribner, 2021) coauthored with health journalist Stacey Colino.

Her premise that EDCs pose a risk to both male and female fertility is underscored by new research. A March 2021 article in Human Reproduction links prenatal chemical exposures to lowered fertility in a study of 1,045 Swiss military conscripts.

The Swiss men, aged 18-22 years, were significantly more likely to have low semen volume and low total sperm count if their mothers reported that they had occupational exposures to four or more endocrine-disrupting chemicals while they were pregnant. These EDCs, which mimic natural hormones, included pesticides, heavy metals, phthalates, alkylphenolic compounds, and solvents that can be found in agricultural work or hair and beauty salons.

These chemicals are not so-called “forever chemicals” that persist in the human body. But the Swiss study still showed an association between exposure during pregnancy and the future fertility of the male children. “Those apparently small exposures that pass quickly can affect development,” said Dr. Swan, who was not affiliated with the research. “It takes very little in terms of time and amount of chemicals to alter fetal development.”
 

Health risks beyond reproduction

While Count Down is placing a new spotlight on chemical hazards, some major medical organizations have already taken positions on the risks. “Reducing exposure to toxic environmental agents is a critical area of intervention for ob.gyns.,” the American College of Obstetricians and Gynecologists said in an environmental policy priority. “The Endocrine Society is concerned that human health is at risk because the current extensive scientific knowledge on EDCs and their health effects is not effectively translated to regulatory policies that fully protect populations from EDC exposures.”

But for the medical community, addressing the impact of EDCs goes beyond advocacy for regulatory and legislative changes, Dr. Swan said in an interview. Physicians should talk to patients about the importance of reducing their chemical exposure to safeguard their overall health.

“Reproductive health and particularly sperm count, subfertility, and infertility are predictors of lifelong health,” she said. That includes associations between reproductive disorders and “the risk of heart disease, obesity, reproductive cancers and, perhaps most dramatically, with a shortened lifespan.”

Some medical schools are including information on environmental health and exposure risks in the curriculum, said Tracey Woodruff, PhD, MPH, director of the program on reproductive health and the environment at the University of California, San Francisco. She urged physicians to ask patients about potential occupational exposures to hazardous chemicals and provide information about ways to reduce everyday exposures.

For example, safer options include buying organic produce, microwaving food in glass rather than plastic containers and avoiding products that contain phthalate or BPA. “If you’re going to talk to people about what they eat, that’s a perfect venue for talking about the environment,” said Dr. Woodruff, who coedited the textbook, Environmental Impacts on Reproductive Health and Fertility (Cambridge University Press: Cambridge, England, 2010).

The UCSF program provides patient guides in English and Spanish with suggestions of ways to reduce chemical exposures at work and at home.
 

Limits in the data

Michael Eisenberg, MD, a urologist and director of male reproductive medicine and surgery at Stanford (Calif.) University Medical Center, often gets questions from patients about how lifestyle and environmental exposures affect male fertility. (In her book, Dr. Swan also discusses how factors such as diet, exercise, smoking, and stress can affect male and female fertility.)

He found the evidence convincing that certain chemicals impact fertility – although, of course, it isn’t ethically possible to do randomized, controlled trials in which some people are intentionally exposed to chemicals to measure the effects. Along with adopting other healthy habits, he advised patients to avoid chemical exposures.

“It’s reasonable to try to eat organic and be mindful of where some of these exposures come from and try to minimize them to the extent possible,” he said.

Rebecca Sokol, MD, MPH, an endocrinologist and expert in male reproductive health, demonstrated the toxic effects of lead on sperm production in studies conducted on rats. But she views low-dose chemical exposure from everyday products as just one aspect of modern reproductive risks, some of which have stronger associations. For example, testosterone therapy impairs sperm production, and finasteride (a medication for male pattern baldness) has been linked to a reversible decline in sperm count.

“When it comes to these ubiquitous chemicals like phthalate and BPA, we explain to the patient that maybe they’re harmful, but we can’t say for sure,” because of the lack of causal data, said Dr. Sokol, professor emerita at the University of Southern California, who was on the panel that drafted the American Urological Association and American Society of Reproductive Medicine guideline on the diagnosis and treatment of male infertility.

Nonetheless, she advised patients to try to reduce exposures. “I don’t see us eradicating all the chemicals that might be bad for us unless we go back to another era. But we can do the best we can to avoid what we can.”
 

A call to action

Dr. Swan likened awareness of the health threat of chemical exposures to the gradual recognition of the climate crisis as a global imperative. Yet in some ways, the scientific work on chemical effects is even more daunting. The Environmental Protection Agency lists more than 86,000 chemicals on its inventory of chemical substances manufactured or imported into the United States.

Little is known about the potential effects of many chemicals that we inhale, ingest or absorb through our skin, Dr. Swan said. In her book, she noted the impact on wildlife – for example, reproductive abnormalities in frogs, alligators, and birds that were exposed to EDCs.

Yet Dr. Swan also takes solace in the lessons from the animal kingdom. Decades after the pesticide DDT, a neurotoxin and endocrine-disruptor, was banned in the United States in 1972, the bald eagle has made a comeback from near-extinction. She also pointed to a 2018 study which found that, while mice exposed to bisphenols passed on reproductive effects to offspring, when the exposures stopped, the effects disappeared after several generations.

“If we stop poisoning ourselves, we can turn this around,” said Dr. Swan. “That’s what I want people to know.”

Count Down frames the issues in language that is much starker than typically found in academic publications. But that is what’s necessary to draw attention to the effects of chemical exposures on human health and reproduction, Dr. Swan said. “I’m saying this in fairly extreme terms to alarm people, to make them realize it is a crisis and they have to act.”

No disclosures were reported.

Chemicals that pervade our modern world – plastics, pesticides, stain repellents, components of personal hygiene products – are contributing to a decades-long decline in fertility and could pose health risks even into future generations, according to an explosive new book by Shanna Swan, PhD, an environmental and reproductive epidemiologist at the Icahn School of Medicine at Mount Sinai, New York.

Dr. Swan laid out the case that endocrine-disrupting chemicals (EDCs) such as phthalates and bisphenol A (BPA) threaten human existence, a conclusion that stems in part from her 2017 meta-analysis that showed a 52% drop in sperm counts from 1973 to 2011 in men in North America, Europe, and Australia.

“This alarming rate of decline could mean the human race will be unable to reproduce itself if the trend continues,” Dr. Swan said in her book, “Count Down: How Our Modern World Is Threatening Sperm Counts, Altering Male and Female Reproductive Development, and Imperiling the Future of the Human Race,” (New York: Scribner, 2021) coauthored with health journalist Stacey Colino.

Her premise that EDCs pose a risk to both male and female fertility is underscored by new research. A March 2021 article in Human Reproduction links prenatal chemical exposures to lowered fertility in a study of 1,045 Swiss military conscripts.

The Swiss men, aged 18-22 years, were significantly more likely to have low semen volume and low total sperm count if their mothers reported that they had occupational exposures to four or more endocrine-disrupting chemicals while they were pregnant. These EDCs, which mimic natural hormones, included pesticides, heavy metals, phthalates, alkylphenolic compounds, and solvents that can be found in agricultural work or hair and beauty salons.

These chemicals are not so-called “forever chemicals” that persist in the human body. But the Swiss study still showed an association between exposure during pregnancy and the future fertility of the male children. “Those apparently small exposures that pass quickly can affect development,” said Dr. Swan, who was not affiliated with the research. “It takes very little in terms of time and amount of chemicals to alter fetal development.”
 

Health risks beyond reproduction

While Count Down is placing a new spotlight on chemical hazards, some major medical organizations have already taken positions on the risks. “Reducing exposure to toxic environmental agents is a critical area of intervention for ob.gyns.,” the American College of Obstetricians and Gynecologists said in an environmental policy priority. “The Endocrine Society is concerned that human health is at risk because the current extensive scientific knowledge on EDCs and their health effects is not effectively translated to regulatory policies that fully protect populations from EDC exposures.”

But for the medical community, addressing the impact of EDCs goes beyond advocacy for regulatory and legislative changes, Dr. Swan said in an interview. Physicians should talk to patients about the importance of reducing their chemical exposure to safeguard their overall health.

“Reproductive health and particularly sperm count, subfertility, and infertility are predictors of lifelong health,” she said. That includes associations between reproductive disorders and “the risk of heart disease, obesity, reproductive cancers and, perhaps most dramatically, with a shortened lifespan.”

Some medical schools are including information on environmental health and exposure risks in the curriculum, said Tracey Woodruff, PhD, MPH, director of the program on reproductive health and the environment at the University of California, San Francisco. She urged physicians to ask patients about potential occupational exposures to hazardous chemicals and provide information about ways to reduce everyday exposures.

For example, safer options include buying organic produce, microwaving food in glass rather than plastic containers and avoiding products that contain phthalate or BPA. “If you’re going to talk to people about what they eat, that’s a perfect venue for talking about the environment,” said Dr. Woodruff, who coedited the textbook, Environmental Impacts on Reproductive Health and Fertility (Cambridge University Press: Cambridge, England, 2010).

The UCSF program provides patient guides in English and Spanish with suggestions of ways to reduce chemical exposures at work and at home.
 

Limits in the data

Michael Eisenberg, MD, a urologist and director of male reproductive medicine and surgery at Stanford (Calif.) University Medical Center, often gets questions from patients about how lifestyle and environmental exposures affect male fertility. (In her book, Dr. Swan also discusses how factors such as diet, exercise, smoking, and stress can affect male and female fertility.)

He found the evidence convincing that certain chemicals impact fertility – although, of course, it isn’t ethically possible to do randomized, controlled trials in which some people are intentionally exposed to chemicals to measure the effects. Along with adopting other healthy habits, he advised patients to avoid chemical exposures.

“It’s reasonable to try to eat organic and be mindful of where some of these exposures come from and try to minimize them to the extent possible,” he said.

Rebecca Sokol, MD, MPH, an endocrinologist and expert in male reproductive health, demonstrated the toxic effects of lead on sperm production in studies conducted on rats. But she views low-dose chemical exposure from everyday products as just one aspect of modern reproductive risks, some of which have stronger associations. For example, testosterone therapy impairs sperm production, and finasteride (a medication for male pattern baldness) has been linked to a reversible decline in sperm count.

“When it comes to these ubiquitous chemicals like phthalate and BPA, we explain to the patient that maybe they’re harmful, but we can’t say for sure,” because of the lack of causal data, said Dr. Sokol, professor emerita at the University of Southern California, who was on the panel that drafted the American Urological Association and American Society of Reproductive Medicine guideline on the diagnosis and treatment of male infertility.

Nonetheless, she advised patients to try to reduce exposures. “I don’t see us eradicating all the chemicals that might be bad for us unless we go back to another era. But we can do the best we can to avoid what we can.”
 

A call to action

Dr. Swan likened awareness of the health threat of chemical exposures to the gradual recognition of the climate crisis as a global imperative. Yet in some ways, the scientific work on chemical effects is even more daunting. The Environmental Protection Agency lists more than 86,000 chemicals on its inventory of chemical substances manufactured or imported into the United States.

Little is known about the potential effects of many chemicals that we inhale, ingest or absorb through our skin, Dr. Swan said. In her book, she noted the impact on wildlife – for example, reproductive abnormalities in frogs, alligators, and birds that were exposed to EDCs.

Yet Dr. Swan also takes solace in the lessons from the animal kingdom. Decades after the pesticide DDT, a neurotoxin and endocrine-disruptor, was banned in the United States in 1972, the bald eagle has made a comeback from near-extinction. She also pointed to a 2018 study which found that, while mice exposed to bisphenols passed on reproductive effects to offspring, when the exposures stopped, the effects disappeared after several generations.

“If we stop poisoning ourselves, we can turn this around,” said Dr. Swan. “That’s what I want people to know.”

Count Down frames the issues in language that is much starker than typically found in academic publications. But that is what’s necessary to draw attention to the effects of chemical exposures on human health and reproduction, Dr. Swan said. “I’m saying this in fairly extreme terms to alarm people, to make them realize it is a crisis and they have to act.”

No disclosures were reported.

Chemicals that pervade our modern world – plastics, pesticides, stain repellents, components of personal hygiene products – are contributing to a decades-long decline in fertility and could pose health risks even into future generations, according to an explosive new book by Shanna Swan, PhD, an environmental and reproductive epidemiologist at the Icahn School of Medicine at Mount Sinai, New York.

Dr. Swan laid out the case that endocrine-disrupting chemicals (EDCs) such as phthalates and bisphenol A (BPA) threaten human existence, a conclusion that stems in part from her 2017 meta-analysis that showed a 52% drop in sperm counts from 1973 to 2011 in men in North America, Europe, and Australia.

“This alarming rate of decline could mean the human race will be unable to reproduce itself if the trend continues,” Dr. Swan said in her book, “Count Down: How Our Modern World Is Threatening Sperm Counts, Altering Male and Female Reproductive Development, and Imperiling the Future of the Human Race,” (New York: Scribner, 2021) coauthored with health journalist Stacey Colino.

Her premise that EDCs pose a risk to both male and female fertility is underscored by new research. A March 2021 article in Human Reproduction links prenatal chemical exposures to lowered fertility in a study of 1,045 Swiss military conscripts.

The Swiss men, aged 18-22 years, were significantly more likely to have low semen volume and low total sperm count if their mothers reported that they had occupational exposures to four or more endocrine-disrupting chemicals while they were pregnant. These EDCs, which mimic natural hormones, included pesticides, heavy metals, phthalates, alkylphenolic compounds, and solvents that can be found in agricultural work or hair and beauty salons.

These chemicals are not so-called “forever chemicals” that persist in the human body. But the Swiss study still showed an association between exposure during pregnancy and the future fertility of the male children. “Those apparently small exposures that pass quickly can affect development,” said Dr. Swan, who was not affiliated with the research. “It takes very little in terms of time and amount of chemicals to alter fetal development.”
 

Health risks beyond reproduction

While Count Down is placing a new spotlight on chemical hazards, some major medical organizations have already taken positions on the risks. “Reducing exposure to toxic environmental agents is a critical area of intervention for ob.gyns.,” the American College of Obstetricians and Gynecologists said in an environmental policy priority. “The Endocrine Society is concerned that human health is at risk because the current extensive scientific knowledge on EDCs and their health effects is not effectively translated to regulatory policies that fully protect populations from EDC exposures.”

But for the medical community, addressing the impact of EDCs goes beyond advocacy for regulatory and legislative changes, Dr. Swan said in an interview. Physicians should talk to patients about the importance of reducing their chemical exposure to safeguard their overall health.

“Reproductive health and particularly sperm count, subfertility, and infertility are predictors of lifelong health,” she said. That includes associations between reproductive disorders and “the risk of heart disease, obesity, reproductive cancers and, perhaps most dramatically, with a shortened lifespan.”

Some medical schools are including information on environmental health and exposure risks in the curriculum, said Tracey Woodruff, PhD, MPH, director of the program on reproductive health and the environment at the University of California, San Francisco. She urged physicians to ask patients about potential occupational exposures to hazardous chemicals and provide information about ways to reduce everyday exposures.

For example, safer options include buying organic produce, microwaving food in glass rather than plastic containers and avoiding products that contain phthalate or BPA. “If you’re going to talk to people about what they eat, that’s a perfect venue for talking about the environment,” said Dr. Woodruff, who coedited the textbook, Environmental Impacts on Reproductive Health and Fertility (Cambridge University Press: Cambridge, England, 2010).

The UCSF program provides patient guides in English and Spanish with suggestions of ways to reduce chemical exposures at work and at home.
 

Limits in the data

Michael Eisenberg, MD, a urologist and director of male reproductive medicine and surgery at Stanford (Calif.) University Medical Center, often gets questions from patients about how lifestyle and environmental exposures affect male fertility. (In her book, Dr. Swan also discusses how factors such as diet, exercise, smoking, and stress can affect male and female fertility.)

He found the evidence convincing that certain chemicals impact fertility – although, of course, it isn’t ethically possible to do randomized, controlled trials in which some people are intentionally exposed to chemicals to measure the effects. Along with adopting other healthy habits, he advised patients to avoid chemical exposures.

“It’s reasonable to try to eat organic and be mindful of where some of these exposures come from and try to minimize them to the extent possible,” he said.

Rebecca Sokol, MD, MPH, an endocrinologist and expert in male reproductive health, demonstrated the toxic effects of lead on sperm production in studies conducted on rats. But she views low-dose chemical exposure from everyday products as just one aspect of modern reproductive risks, some of which have stronger associations. For example, testosterone therapy impairs sperm production, and finasteride (a medication for male pattern baldness) has been linked to a reversible decline in sperm count.

“When it comes to these ubiquitous chemicals like phthalate and BPA, we explain to the patient that maybe they’re harmful, but we can’t say for sure,” because of the lack of causal data, said Dr. Sokol, professor emerita at the University of Southern California, who was on the panel that drafted the American Urological Association and American Society of Reproductive Medicine guideline on the diagnosis and treatment of male infertility.

Nonetheless, she advised patients to try to reduce exposures. “I don’t see us eradicating all the chemicals that might be bad for us unless we go back to another era. But we can do the best we can to avoid what we can.”
 

A call to action

Dr. Swan likened awareness of the health threat of chemical exposures to the gradual recognition of the climate crisis as a global imperative. Yet in some ways, the scientific work on chemical effects is even more daunting. The Environmental Protection Agency lists more than 86,000 chemicals on its inventory of chemical substances manufactured or imported into the United States.

Little is known about the potential effects of many chemicals that we inhale, ingest or absorb through our skin, Dr. Swan said. In her book, she noted the impact on wildlife – for example, reproductive abnormalities in frogs, alligators, and birds that were exposed to EDCs.

Yet Dr. Swan also takes solace in the lessons from the animal kingdom. Decades after the pesticide DDT, a neurotoxin and endocrine-disruptor, was banned in the United States in 1972, the bald eagle has made a comeback from near-extinction. She also pointed to a 2018 study which found that, while mice exposed to bisphenols passed on reproductive effects to offspring, when the exposures stopped, the effects disappeared after several generations.

“If we stop poisoning ourselves, we can turn this around,” said Dr. Swan. “That’s what I want people to know.”

Count Down frames the issues in language that is much starker than typically found in academic publications. But that is what’s necessary to draw attention to the effects of chemical exposures on human health and reproduction, Dr. Swan said. “I’m saying this in fairly extreme terms to alarm people, to make them realize it is a crisis and they have to act.”

No disclosures were reported.

Effective transitions of care (TOC) are essential to ensure quality continuity of care after hospital discharge. About 20 to 30% of patients experience an adverse event (AE) in the peridischarge period when discharged to the community.¹ Additionally, about two-thirds of AEs are preventable.¹ The Joint Commission has identified various breakdowns in care that are associated with poor outcomes, including a lack of standardized discharge procedures, limited time dedicated to discharge planning and processes, and patients who lack the necessary resources or skills to implement discharge care plans.²

Background

The most impactful TOC programs are those that target patients who are at high risk for readmission or adverse outcomes.³ Factors such as advanced age, polypharmacy, cognitive impairment, and lack of social support are patient characteristics that have been associated with unfavorable outcomes after discharge.⁴ To identify this subset of high-risk individuals, various risk assessment scores have been developed, ranging from those that are used locally at the facility level to those that are nationally validated. The LACE score (Length of hospital stay; Acuity of the admission; Comorbidities measured with the Charlson comorbidity index score; and Emergency department visits within the past 6 months) is a validated index scoring tool that is used to identify medical and surgical patients at risk for readmission or death within 30 days of hospital discharge. On a 19-point scale, a score of ≥ 10 is considered high risk.⁵ Specific to the US Department of Veterans Affairs (VA), the Care Assessment Needs (CAN) score was developed to risk stratify the veteran population. The CAN score is generated using information including patient demographics, medical conditions, VA health care utilization, vital signs, laboratory values, medications, and socioeconomic status. This score is expressed as a percentile that compares the probability of death or admission among veterans at 90 days and 1 year postdischarge. Veterans in the 99th percentile have a 74% risk for these adverse outcomes at 1 year.⁶

The Joint Commission states that a fundamental component to assuring safe and effective TOC is medication management, which includes the involvement of pharmacists.² TOC programs with pharmacist involvement have shown significant improvements related to reduced 30-day hospital readmissions and health care costs in addition to significant medication-related interventions.^7-9 While this body of evidence continues to grow and demonstrates that pharmacists are an integral component of the TOC process, there is no gold standard program. Brantley and colleagues noted that a weakness of many TOC programs is that they are one dimensional, meaning that they focus on only 1 element of care transitions or 1 specific patient population or disease.¹⁰

There is well-supported evidence of high-impact interventions for pharmacists involved early in the admission process, but data are less robust on the discharge process. ^11,12 Therefore, the primary focus of this project was to develop a pharmacist-based TOC program and implement a process for communicating high-risk patients who are discharging from our hospital across the continuum of care.

Setting

The Richard L. Roudebush VA Medical Center (RLRVAMC) is a tertiary care referral center for veterans in Indiana and eastern Illinois. Acute care clinical pharmacists are fully integrated into the acute care teams and practice under a comprehensive care model. Pharmacists attend daily patient care rounds and conduct discharge medication reconciliation for all patients with additional bedside counseling for patients who are being discharged home.

Primary care services are provided by patient aligned care teams (PACTs), multidisciplinary teams composed of physicians, advanced practice nurses, pharmacists, mental health care providers, registered nurses, dieticians, and care coordinators. Ambulatory Care or PACT clinical pharmacists are established within each RLRVAMC PACT clinic and provide comprehensive care management through an independent scope of practice for several chronic diseases, including hypertension, type 2 diabetes mellitus (T2DM), dyslipidemia, hypothyroidism, and tobacco cessation. Prior to this project implementation, there was no formalized or standardized method for facilitating routine communication of patients between acute care and PACT pharmacists in the TOC process.

Pilot Study

In 2017, RLRVAMC implemented a TOC pharmacy program pilot. A pharmacy resident and both acute care and PACT clinical pharmacy specialists (CPSs) developed the service. The pilot program was conducted from September 1, 2017 to March 1, 2018. The initial phase consisted of the development of an electronic TOC tool to standardize communication between acute care and PACT pharmacists. The TOC tool was created on a secure site accessible only to pharmacy personnel and not part of the formal medical record. (Figure 1).

The acute care pharmacist identified high-risk patients through calculated CAN and LACE scores during the discharge process and offered PACT pharmacist follow-up to the patient during bedside discharge counseling. Information was then entered into the TOC tool, including patient identifiers and a message with specific information outlining the reason for referral. PACT pharmacists routinely reviewed the tool and attempted to phone each patient within 7 days of discharge. Follow-up included medication reconciliation and chronic disease management as warranted at the discretion of the PACT pharmacist. All postdischarge follow-up appointments were created and documented in the electronic health record. A retrospective chart review was completed on patients who were entered into the TOC tool.

Patients were eligible for referral if they were discharged during the study period with primary care established in one of the facility’s PACT clinics. Additionally, patients had to meet ≥ 1 of the following criteria, deeming them a high risk for readmission: LACE score ≥ 10, CAN score ≥ 90th percentile, or be considered high risk based on the discretion of the acute care pharmacist. Patients were included in the analysis if they met the CAN or LACE score requirement. Patients were excluded if they received primary care from a site other than a RLRVAMC PACT clinic. This included non-VA primary care, home-based primary care, or VA community-based outpatient clinics (CBOCs). Patients also were excluded if they required further institutional care postdischarge (ie, subacute rehabilitation, extended care facility, etc), discharged to hospice, or against medical advice.

The average referral rate per month during the pilot study was 19 patients, with 113 total referrals during the 6-month study period. Lower rates of index emergency department (ED) visits (5.3% vs 23.3%) and readmissions (1% vs 6.7%) were seen in the group of patients who received PACT pharmacist follow-up postdischarge compared with those who did not. Additionally, PACT pharmacists were able to make > 120 interventions, averaging 1.7 interventions per patient. Of note, these results were not statistically analyzed and were assessed as observational data to determine whether the program had the potential to be impactful. The results of the pilot study demonstrated positive outcomes associated with having a pharmacist-based TOC process and led to the desire for further development and implementation of the TOC program at the RLRVAMC. These positive results prompted a second phase project to address barriers, make improvements, and ensure sustainability.

Methods

Phase 2 was a quality improvement initiative; therefore, institutional review board approval was not needed. The aim of phase 2 was to improve, expand, and sustain the TOC program that was implemented in the pilot study. Barriers identified after discussion with acute care and PACT pharmacists included difficulty in making referrals due to required entry of cumbersome readmission risk factor calculations, limiting inclusion to patients who receive primary care at the main hospital facility, and the expansion of pharmacy staff with new pharmacists who were not knowledgeable of the referral process.

Design

To overcome barriers, 4 main targeted interventions were needed: streamlining the referral process, enhancing pharmacy staff education, updating the discharge note template, and expanding the criteria to include patients who receive care at VA CBOCs. The referral process was streamlined by removing required calculated readmission risk scores, allowing pharmacist judgement to take precedence for referrals. Focused face-to-face education was provided to acute care and PACT pharmacists about the referral process and inclusion criteria to increase awareness and provide guidance of who may benefit from entry into the tool. Unlike the first phase of the study, education was provided for outpatient staff pharmacists responsible for discharging patients on the weekends. Additionally, the pharmacists received a printed quick reference guide of the information covered during the education sessions (Figure 2). Referral prompts were embedded into the standard pharmacy discharge note template to serve as a reminder to discharging pharmacists to assess patients for inclusion into the tool and provided a direct link to the tool. Expansion to include VA CBOCs occurred postpilot study, allowing increased patient access to this TOC service. All other aspects of the program were continued from the pilot phase.

Patients were eligible if they were discharged from RLRVAMC between October 1, 2018 and February 28, 2019. Additionally, the patient had to be established in a PACT clinic for primary care and have been referred to the tool based on the discretion of an acute care pharmacist. Patients were excluded if they were discharged against medical advice or to any facility where the patient and/or caregiver would not be responsible for medication administration (eg, subacute rehabilitation, extended care facility), or if the patient refused pharmacy follow-up.

Outcomes

The primary outcomes assessed were all-cause and index ED visits and readmissions within 30 days of discharge. All-cause ED visits and readmissions were defined as a second visit to RLRVAMC , regardless of readmission diagnosis. Index ED visits and readmissions were defined as those that were related to the initial admission diagnosis. Additional data collected and analyzed included the number of patients referred by pharmacists, number and type of medication discrepancies, medication changes, counseling interventions, time to follow-up postdischarge, and number of patients added to the PACT pharmacist’s clinic schedule for further management. A discrepancy identified by a PACT pharmacist was defined as a difference between the discharge medication list and the patient-reported medication list at the time of follow-up. Patients who were referred to the TOC tool but were unable to be reached by telephone served as the control group for this study.

Data Collection

A retrospective chart review was completed on patients entered into the tool. Data were collected and kept in a secured Microsoft Excel workbook. Baseline characteristics were analyzed using either a χ² for nominal data or Student t test for continuous data. The primary outcomes were analyzed using a χ² test. All statistical tests were analyzed using MiniTab 19 Statistical Software.

Results

Pharmacists added 172 patients into the TOC tool; 139 patients met inclusion criteria. Of those excluded, most were because the PACT pharmacist did not attempt to contact the patient since they already had a primary care visit scheduled postdischarge (Table 1). Of the 139 patients who met the inclusion criteria, 99 were successfully contacted by a PACT pharmacist. Most patients were aged in their 60s, male, and white. Both groups had a similar quantity of outpatient medications on admission and medication changes made at discharge. Additionally, both groups had a similar number of patients with hospitalizations and/or ED visits in the 3 months before hospital admission that resulted in TOC tool referral (Table 2).

Hospital Readmission

Hospital 30-day readmission rates for patients who were successfully followed by pharmacy compared with those who were not were 5.1% vs 15.0% (P = .049) for index readmissions and 8.1% vs 27.5% (P = .03) for all-cause readmissions. No statistically significant difference existed between those patients with follow-up compared with those without follow-up for either index (10.1% vs 12.5%, respectively; P = .68) or for all-cause ED visit rates (15.2% vs 20.0%, respectively; P = .49).

Patient Encounters

The average time to follow-up was 8.8 days, which was above the predetermined goal of contact within 7 days. Additionally, this was a decline from the initial pilot study, which had an average time to reach of 4.7 days. All patients reached by a pharmacist received medication reconciliation, with ≥ 28% of patients having ≥ 1 discrepancy. There were 43 discrepancies among all patients. Of the discrepancies, 25 were reported as errors performed by the patient, and 18 were from an error during the discharge process. The discrepancies that resulted from patient error were primarily patients who took the wrong dose of prescribed medications. Other patient discrepancies included taking medications not as scheduled, omitting medications (both intentionally and mistakenly), continuing to take medications that had been discontinued by a health care provider and improper administration technique. Examples of provider errors that occurred during the discharge process included not ordering medications for patient to pick up at discharge, not discontinuing a medication from the patient’s profile, and failure to renew expired prescriptions.

Additional counseling was provided to 75% of patients: The most common reason for counseling was T2DM, hypertension, and dyslipidemia management. PACT pharmacists changed medication regimens for 27.3% of patients for improved control of chronic diseases or relief of medication AEs.

At the end of each visit, patients were assessed to determine whether they could benefit from additional pharmacy follow-up. Thirty-seven patients were added to the pharmacist schedules for disease management appointments. The most common conditions for these appointments were T2DM, hypertension, tobacco cessation, and hyperlipidemia. Among the 37 patients who had pharmacy follow-up, there were 137 additional pharmacy appointments within the study period.

Program Referrals

After expansion to include the VA CBOCs, elimination of the elevated LACE or CAN score requirement, and additional staff education, the rate of referrals per month increased during phase 2 in comparison to the pilot study (Figure 3). There were a mean (SD) of 34 (10) referrals per month. Although not statistically analyzed, it is an objective increase in comparison to a mean 19 referrals per month in the pilot study.

Discussion

The continued development and use of a pharmacist-driven TOC tool at RLRVAMC increased communication and follow-up of high-risk patients, demonstrated the ability of pharmacists to identify and intervene in medication-related issues postdischarge, and successfully reduce 30-day readmissions. This program emphasized pharmacist involvement during the discharge process and created a standardized mechanism for TOC follow-up, addressing multiple areas that were identified by The Joint Commission as being associated with poor outcomes. The advanced pharmacy practice model at RLRVAMC allowed for a multidimensional program, including prospective patient identification and multiple pharmacy touchpoints. This is unique in comparison to many of the one-dimensional programs described in the literature.

Polypharmacy has been identified as a major predictor of medication discrepancies postdischarge, and patients with ≥ 10 active medications have been found to be at highest risk.^13,14 Patients in this study had a mean 13 active medications on admission, with a mean 5 medication changes at discharge. PACT pharmacists documented 28 of 99 patients with ≥ 1 medication-related discrepancy at postdischarge reconciliation. This 28% discrepancy rate is consistent with discrepancy rates previously reported in the literature, which ranged from 14 to 45% in large meta-analyses.^14,15 The majority of these discrepancies (58%) were related to patients who took the wrong dose of a prescribed medication.

Targeted interventions to overcome barriers in the pilot study increased the referral rates to the TOC tool; however, the increase in referral rate was associated with increased time to follow up by ambulatory care pharmacists. The extended follow-up times were seen most often in the 2 busiest primary care clinics, one of which is considered a teaching clinic for medical residents. Pharmacists were required to integrate these calls into their normal work schedule and were not provided additional time for calling, allowing for an increased follow-up time. The increased follow-up time likely contributed to the increased number of patients excluded due to already having PACT follow-up, giving more time for the primary care provider to have an appointment with the patient. The ambulatory care pharmacist could then determine whether further intervention was needed. In the summer of 2018, a decrease in referral rates occurred for a short time, but this is likely explained by incoming new residents and staff within the pharmacy department and decreased awareness among the new staff. The enhanced staff education took place during September 2018 and lead to increased referral rates compared with those seen in months prior.

PACT pharmacists were not only able to identify discrepancies, but also provide timely intervention on a multitude of medication-related issues by using their scope of practice (SOP). Most interventions were related to medication or disease counseling, including lifestyle, device, and disease education. The independent SOP of our PACT pharmacists is a unique aspect of this program and allowed pharmacists to independently adjust many aspects of a patient’s medication regimen during follow-up visits.

The outcomes of 30-day index and all-cause readmissions, as well as index and all-cause ED visit rates, were lower in the subset of patients who received PACT pharmacist follow-up after discharge (Table 3). The difference was most pronounced in the all-cause readmission rates: Only 8.1% of patients who received PACT follow-up experienced a readmission compared with 27.5% of those who did not. The difference between the groups regarding ED visit rates were not as pronounced, but this may be attributed to a limited sample size. These data indicate that the role of the pharmacist in identifying discrepancies and performing interventions at follow-up may play a clinically significant part in reducing both ED visit rates and hospital readmissions.

Limitations

There are some limitations identified within this study. Although the referral criteria were relaxed from the pilot study and enhanced education was created, continued education regarding appropriate referral of TOC patients continues to be necessary given intermittent staff changeover, incorporation of pharmacy trainees, and modifications to clinic workflow. Patients who were discharged to facilities were not included. This ensured that appropriate and consistent PACT pharmacist follow-up would be available, but likely reduced our sample size.

Although performing this study in a closed health care system with pharmacists who have independent SOPs is a strength of our study, also it can limit generalizability. Not all facilities house both acute care and ambulatory care in one location with wide SOPs to allow for comprehensive and continued care. Last, this study used convenience sampling, potentially introducing selection bias, as patients unable to be reached by PACT pharmacists may inherently be at increased risk for hospital readmission. However, in the 3 months preceding the hospital admission that resulted in TOC tool referral, both groups had a similar number of patients with hospital admissions and ED visits.

The TOC tool has become fully integrated into the daily workflow for both acute care and PACT pharmacists. After the conclusion of the study period, the referral rates into the tool have been maintained at a steady level, even surpassing the rates seen during the study period. In comparison with the pilot study, PACT pharmacists reported a subjective increase in referrals placed for procedures such as medication reconciliation or adherence checks. This is likely because acute care pharmacists were able to use their clinical judgement rather than to rely solely on calculated readmission risk scores for TOC tool referral.

The success of the TOC program led to the expansion to other specialty areas. ED pharmacists now refer patients from the ED who were not admitted to the hospital but would benefit from PACT follow-up. Additionally, the option to refer hematology and oncology patients was added to allow these patients to be followed up by our hematology/oncology CPSs by phone appointments. Unique reasons for follow-up for this patient population include concerns about delayed chemotherapy cycles or chemotherapy-associated AEs.

Conclusions

This study outlines the creation and continued improvement of a pharmacist-based TOC program. The program was designed as a method of communication between acute care and PACT pharmacists about high-risk patients. The creation of this program allowed PACT pharmacists not only to identify discrepancies and make interventions on high-risk patients, but also demonstrate that having pharmacists involved in these programs may have a positive impact on readmissions and ED visits. The success of the TOC tool at the RLRVAMC has led to its expansion and is now an integral part of the daily workflow for both acute care and PACT pharmacists.

Effective transitions of care (TOC) are essential to ensure quality continuity of care after hospital discharge. About 20 to 30% of patients experience an adverse event (AE) in the peridischarge period when discharged to the community.¹ Additionally, about two-thirds of AEs are preventable.¹ The Joint Commission has identified various breakdowns in care that are associated with poor outcomes, including a lack of standardized discharge procedures, limited time dedicated to discharge planning and processes, and patients who lack the necessary resources or skills to implement discharge care plans.²

Background

The most impactful TOC programs are those that target patients who are at high risk for readmission or adverse outcomes.³ Factors such as advanced age, polypharmacy, cognitive impairment, and lack of social support are patient characteristics that have been associated with unfavorable outcomes after discharge.⁴ To identify this subset of high-risk individuals, various risk assessment scores have been developed, ranging from those that are used locally at the facility level to those that are nationally validated. The LACE score (Length of hospital stay; Acuity of the admission; Comorbidities measured with the Charlson comorbidity index score; and Emergency department visits within the past 6 months) is a validated index scoring tool that is used to identify medical and surgical patients at risk for readmission or death within 30 days of hospital discharge. On a 19-point scale, a score of ≥ 10 is considered high risk.⁵ Specific to the US Department of Veterans Affairs (VA), the Care Assessment Needs (CAN) score was developed to risk stratify the veteran population. The CAN score is generated using information including patient demographics, medical conditions, VA health care utilization, vital signs, laboratory values, medications, and socioeconomic status. This score is expressed as a percentile that compares the probability of death or admission among veterans at 90 days and 1 year postdischarge. Veterans in the 99th percentile have a 74% risk for these adverse outcomes at 1 year.⁶

The Joint Commission states that a fundamental component to assuring safe and effective TOC is medication management, which includes the involvement of pharmacists.² TOC programs with pharmacist involvement have shown significant improvements related to reduced 30-day hospital readmissions and health care costs in addition to significant medication-related interventions.^7-9 While this body of evidence continues to grow and demonstrates that pharmacists are an integral component of the TOC process, there is no gold standard program. Brantley and colleagues noted that a weakness of many TOC programs is that they are one dimensional, meaning that they focus on only 1 element of care transitions or 1 specific patient population or disease.¹⁰

There is well-supported evidence of high-impact interventions for pharmacists involved early in the admission process, but data are less robust on the discharge process. ^11,12 Therefore, the primary focus of this project was to develop a pharmacist-based TOC program and implement a process for communicating high-risk patients who are discharging from our hospital across the continuum of care.

Setting

The Richard L. Roudebush VA Medical Center (RLRVAMC) is a tertiary care referral center for veterans in Indiana and eastern Illinois. Acute care clinical pharmacists are fully integrated into the acute care teams and practice under a comprehensive care model. Pharmacists attend daily patient care rounds and conduct discharge medication reconciliation for all patients with additional bedside counseling for patients who are being discharged home.

Primary care services are provided by patient aligned care teams (PACTs), multidisciplinary teams composed of physicians, advanced practice nurses, pharmacists, mental health care providers, registered nurses, dieticians, and care coordinators. Ambulatory Care or PACT clinical pharmacists are established within each RLRVAMC PACT clinic and provide comprehensive care management through an independent scope of practice for several chronic diseases, including hypertension, type 2 diabetes mellitus (T2DM), dyslipidemia, hypothyroidism, and tobacco cessation. Prior to this project implementation, there was no formalized or standardized method for facilitating routine communication of patients between acute care and PACT pharmacists in the TOC process.

Pilot Study

In 2017, RLRVAMC implemented a TOC pharmacy program pilot. A pharmacy resident and both acute care and PACT clinical pharmacy specialists (CPSs) developed the service. The pilot program was conducted from September 1, 2017 to March 1, 2018. The initial phase consisted of the development of an electronic TOC tool to standardize communication between acute care and PACT pharmacists. The TOC tool was created on a secure site accessible only to pharmacy personnel and not part of the formal medical record. (Figure 1).

The acute care pharmacist identified high-risk patients through calculated CAN and LACE scores during the discharge process and offered PACT pharmacist follow-up to the patient during bedside discharge counseling. Information was then entered into the TOC tool, including patient identifiers and a message with specific information outlining the reason for referral. PACT pharmacists routinely reviewed the tool and attempted to phone each patient within 7 days of discharge. Follow-up included medication reconciliation and chronic disease management as warranted at the discretion of the PACT pharmacist. All postdischarge follow-up appointments were created and documented in the electronic health record. A retrospective chart review was completed on patients who were entered into the TOC tool.

Patients were eligible for referral if they were discharged during the study period with primary care established in one of the facility’s PACT clinics. Additionally, patients had to meet ≥ 1 of the following criteria, deeming them a high risk for readmission: LACE score ≥ 10, CAN score ≥ 90th percentile, or be considered high risk based on the discretion of the acute care pharmacist. Patients were included in the analysis if they met the CAN or LACE score requirement. Patients were excluded if they received primary care from a site other than a RLRVAMC PACT clinic. This included non-VA primary care, home-based primary care, or VA community-based outpatient clinics (CBOCs). Patients also were excluded if they required further institutional care postdischarge (ie, subacute rehabilitation, extended care facility, etc), discharged to hospice, or against medical advice.

The average referral rate per month during the pilot study was 19 patients, with 113 total referrals during the 6-month study period. Lower rates of index emergency department (ED) visits (5.3% vs 23.3%) and readmissions (1% vs 6.7%) were seen in the group of patients who received PACT pharmacist follow-up postdischarge compared with those who did not. Additionally, PACT pharmacists were able to make > 120 interventions, averaging 1.7 interventions per patient. Of note, these results were not statistically analyzed and were assessed as observational data to determine whether the program had the potential to be impactful. The results of the pilot study demonstrated positive outcomes associated with having a pharmacist-based TOC process and led to the desire for further development and implementation of the TOC program at the RLRVAMC. These positive results prompted a second phase project to address barriers, make improvements, and ensure sustainability.

Methods

Phase 2 was a quality improvement initiative; therefore, institutional review board approval was not needed. The aim of phase 2 was to improve, expand, and sustain the TOC program that was implemented in the pilot study. Barriers identified after discussion with acute care and PACT pharmacists included difficulty in making referrals due to required entry of cumbersome readmission risk factor calculations, limiting inclusion to patients who receive primary care at the main hospital facility, and the expansion of pharmacy staff with new pharmacists who were not knowledgeable of the referral process.

Design

To overcome barriers, 4 main targeted interventions were needed: streamlining the referral process, enhancing pharmacy staff education, updating the discharge note template, and expanding the criteria to include patients who receive care at VA CBOCs. The referral process was streamlined by removing required calculated readmission risk scores, allowing pharmacist judgement to take precedence for referrals. Focused face-to-face education was provided to acute care and PACT pharmacists about the referral process and inclusion criteria to increase awareness and provide guidance of who may benefit from entry into the tool. Unlike the first phase of the study, education was provided for outpatient staff pharmacists responsible for discharging patients on the weekends. Additionally, the pharmacists received a printed quick reference guide of the information covered during the education sessions (Figure 2). Referral prompts were embedded into the standard pharmacy discharge note template to serve as a reminder to discharging pharmacists to assess patients for inclusion into the tool and provided a direct link to the tool. Expansion to include VA CBOCs occurred postpilot study, allowing increased patient access to this TOC service. All other aspects of the program were continued from the pilot phase.

Patients were eligible if they were discharged from RLRVAMC between October 1, 2018 and February 28, 2019. Additionally, the patient had to be established in a PACT clinic for primary care and have been referred to the tool based on the discretion of an acute care pharmacist. Patients were excluded if they were discharged against medical advice or to any facility where the patient and/or caregiver would not be responsible for medication administration (eg, subacute rehabilitation, extended care facility), or if the patient refused pharmacy follow-up.

Outcomes

The primary outcomes assessed were all-cause and index ED visits and readmissions within 30 days of discharge. All-cause ED visits and readmissions were defined as a second visit to RLRVAMC , regardless of readmission diagnosis. Index ED visits and readmissions were defined as those that were related to the initial admission diagnosis. Additional data collected and analyzed included the number of patients referred by pharmacists, number and type of medication discrepancies, medication changes, counseling interventions, time to follow-up postdischarge, and number of patients added to the PACT pharmacist’s clinic schedule for further management. A discrepancy identified by a PACT pharmacist was defined as a difference between the discharge medication list and the patient-reported medication list at the time of follow-up. Patients who were referred to the TOC tool but were unable to be reached by telephone served as the control group for this study.

Data Collection

A retrospective chart review was completed on patients entered into the tool. Data were collected and kept in a secured Microsoft Excel workbook. Baseline characteristics were analyzed using either a χ² for nominal data or Student t test for continuous data. The primary outcomes were analyzed using a χ² test. All statistical tests were analyzed using MiniTab 19 Statistical Software.

Results

Pharmacists added 172 patients into the TOC tool; 139 patients met inclusion criteria. Of those excluded, most were because the PACT pharmacist did not attempt to contact the patient since they already had a primary care visit scheduled postdischarge (Table 1). Of the 139 patients who met the inclusion criteria, 99 were successfully contacted by a PACT pharmacist. Most patients were aged in their 60s, male, and white. Both groups had a similar quantity of outpatient medications on admission and medication changes made at discharge. Additionally, both groups had a similar number of patients with hospitalizations and/or ED visits in the 3 months before hospital admission that resulted in TOC tool referral (Table 2).

Hospital Readmission

Hospital 30-day readmission rates for patients who were successfully followed by pharmacy compared with those who were not were 5.1% vs 15.0% (P = .049) for index readmissions and 8.1% vs 27.5% (P = .03) for all-cause readmissions. No statistically significant difference existed between those patients with follow-up compared with those without follow-up for either index (10.1% vs 12.5%, respectively; P = .68) or for all-cause ED visit rates (15.2% vs 20.0%, respectively; P = .49).

Patient Encounters

The average time to follow-up was 8.8 days, which was above the predetermined goal of contact within 7 days. Additionally, this was a decline from the initial pilot study, which had an average time to reach of 4.7 days. All patients reached by a pharmacist received medication reconciliation, with ≥ 28% of patients having ≥ 1 discrepancy. There were 43 discrepancies among all patients. Of the discrepancies, 25 were reported as errors performed by the patient, and 18 were from an error during the discharge process. The discrepancies that resulted from patient error were primarily patients who took the wrong dose of prescribed medications. Other patient discrepancies included taking medications not as scheduled, omitting medications (both intentionally and mistakenly), continuing to take medications that had been discontinued by a health care provider and improper administration technique. Examples of provider errors that occurred during the discharge process included not ordering medications for patient to pick up at discharge, not discontinuing a medication from the patient’s profile, and failure to renew expired prescriptions.

Additional counseling was provided to 75% of patients: The most common reason for counseling was T2DM, hypertension, and dyslipidemia management. PACT pharmacists changed medication regimens for 27.3% of patients for improved control of chronic diseases or relief of medication AEs.

At the end of each visit, patients were assessed to determine whether they could benefit from additional pharmacy follow-up. Thirty-seven patients were added to the pharmacist schedules for disease management appointments. The most common conditions for these appointments were T2DM, hypertension, tobacco cessation, and hyperlipidemia. Among the 37 patients who had pharmacy follow-up, there were 137 additional pharmacy appointments within the study period.

Program Referrals

After expansion to include the VA CBOCs, elimination of the elevated LACE or CAN score requirement, and additional staff education, the rate of referrals per month increased during phase 2 in comparison to the pilot study (Figure 3). There were a mean (SD) of 34 (10) referrals per month. Although not statistically analyzed, it is an objective increase in comparison to a mean 19 referrals per month in the pilot study.

Discussion

The continued development and use of a pharmacist-driven TOC tool at RLRVAMC increased communication and follow-up of high-risk patients, demonstrated the ability of pharmacists to identify and intervene in medication-related issues postdischarge, and successfully reduce 30-day readmissions. This program emphasized pharmacist involvement during the discharge process and created a standardized mechanism for TOC follow-up, addressing multiple areas that were identified by The Joint Commission as being associated with poor outcomes. The advanced pharmacy practice model at RLRVAMC allowed for a multidimensional program, including prospective patient identification and multiple pharmacy touchpoints. This is unique in comparison to many of the one-dimensional programs described in the literature.

Polypharmacy has been identified as a major predictor of medication discrepancies postdischarge, and patients with ≥ 10 active medications have been found to be at highest risk.^13,14 Patients in this study had a mean 13 active medications on admission, with a mean 5 medication changes at discharge. PACT pharmacists documented 28 of 99 patients with ≥ 1 medication-related discrepancy at postdischarge reconciliation. This 28% discrepancy rate is consistent with discrepancy rates previously reported in the literature, which ranged from 14 to 45% in large meta-analyses.^14,15 The majority of these discrepancies (58%) were related to patients who took the wrong dose of a prescribed medication.

Targeted interventions to overcome barriers in the pilot study increased the referral rates to the TOC tool; however, the increase in referral rate was associated with increased time to follow up by ambulatory care pharmacists. The extended follow-up times were seen most often in the 2 busiest primary care clinics, one of which is considered a teaching clinic for medical residents. Pharmacists were required to integrate these calls into their normal work schedule and were not provided additional time for calling, allowing for an increased follow-up time. The increased follow-up time likely contributed to the increased number of patients excluded due to already having PACT follow-up, giving more time for the primary care provider to have an appointment with the patient. The ambulatory care pharmacist could then determine whether further intervention was needed. In the summer of 2018, a decrease in referral rates occurred for a short time, but this is likely explained by incoming new residents and staff within the pharmacy department and decreased awareness among the new staff. The enhanced staff education took place during September 2018 and lead to increased referral rates compared with those seen in months prior.

PACT pharmacists were not only able to identify discrepancies, but also provide timely intervention on a multitude of medication-related issues by using their scope of practice (SOP). Most interventions were related to medication or disease counseling, including lifestyle, device, and disease education. The independent SOP of our PACT pharmacists is a unique aspect of this program and allowed pharmacists to independently adjust many aspects of a patient’s medication regimen during follow-up visits.

The outcomes of 30-day index and all-cause readmissions, as well as index and all-cause ED visit rates, were lower in the subset of patients who received PACT pharmacist follow-up after discharge (Table 3). The difference was most pronounced in the all-cause readmission rates: Only 8.1% of patients who received PACT follow-up experienced a readmission compared with 27.5% of those who did not. The difference between the groups regarding ED visit rates were not as pronounced, but this may be attributed to a limited sample size. These data indicate that the role of the pharmacist in identifying discrepancies and performing interventions at follow-up may play a clinically significant part in reducing both ED visit rates and hospital readmissions.

Limitations

There are some limitations identified within this study. Although the referral criteria were relaxed from the pilot study and enhanced education was created, continued education regarding appropriate referral of TOC patients continues to be necessary given intermittent staff changeover, incorporation of pharmacy trainees, and modifications to clinic workflow. Patients who were discharged to facilities were not included. This ensured that appropriate and consistent PACT pharmacist follow-up would be available, but likely reduced our sample size.

Although performing this study in a closed health care system with pharmacists who have independent SOPs is a strength of our study, also it can limit generalizability. Not all facilities house both acute care and ambulatory care in one location with wide SOPs to allow for comprehensive and continued care. Last, this study used convenience sampling, potentially introducing selection bias, as patients unable to be reached by PACT pharmacists may inherently be at increased risk for hospital readmission. However, in the 3 months preceding the hospital admission that resulted in TOC tool referral, both groups had a similar number of patients with hospital admissions and ED visits.

The TOC tool has become fully integrated into the daily workflow for both acute care and PACT pharmacists. After the conclusion of the study period, the referral rates into the tool have been maintained at a steady level, even surpassing the rates seen during the study period. In comparison with the pilot study, PACT pharmacists reported a subjective increase in referrals placed for procedures such as medication reconciliation or adherence checks. This is likely because acute care pharmacists were able to use their clinical judgement rather than to rely solely on calculated readmission risk scores for TOC tool referral.

The success of the TOC program led to the expansion to other specialty areas. ED pharmacists now refer patients from the ED who were not admitted to the hospital but would benefit from PACT follow-up. Additionally, the option to refer hematology and oncology patients was added to allow these patients to be followed up by our hematology/oncology CPSs by phone appointments. Unique reasons for follow-up for this patient population include concerns about delayed chemotherapy cycles or chemotherapy-associated AEs.

Conclusions

This study outlines the creation and continued improvement of a pharmacist-based TOC program. The program was designed as a method of communication between acute care and PACT pharmacists about high-risk patients. The creation of this program allowed PACT pharmacists not only to identify discrepancies and make interventions on high-risk patients, but also demonstrate that having pharmacists involved in these programs may have a positive impact on readmissions and ED visits. The success of the TOC tool at the RLRVAMC has led to its expansion and is now an integral part of the daily workflow for both acute care and PACT pharmacists.

Effective transitions of care (TOC) are essential to ensure quality continuity of care after hospital discharge. About 20 to 30% of patients experience an adverse event (AE) in the peridischarge period when discharged to the community.¹ Additionally, about two-thirds of AEs are preventable.¹ The Joint Commission has identified various breakdowns in care that are associated with poor outcomes, including a lack of standardized discharge procedures, limited time dedicated to discharge planning and processes, and patients who lack the necessary resources or skills to implement discharge care plans.²

Background

The most impactful TOC programs are those that target patients who are at high risk for readmission or adverse outcomes.³ Factors such as advanced age, polypharmacy, cognitive impairment, and lack of social support are patient characteristics that have been associated with unfavorable outcomes after discharge.⁴ To identify this subset of high-risk individuals, various risk assessment scores have been developed, ranging from those that are used locally at the facility level to those that are nationally validated. The LACE score (Length of hospital stay; Acuity of the admission; Comorbidities measured with the Charlson comorbidity index score; and Emergency department visits within the past 6 months) is a validated index scoring tool that is used to identify medical and surgical patients at risk for readmission or death within 30 days of hospital discharge. On a 19-point scale, a score of ≥ 10 is considered high risk.⁵ Specific to the US Department of Veterans Affairs (VA), the Care Assessment Needs (CAN) score was developed to risk stratify the veteran population. The CAN score is generated using information including patient demographics, medical conditions, VA health care utilization, vital signs, laboratory values, medications, and socioeconomic status. This score is expressed as a percentile that compares the probability of death or admission among veterans at 90 days and 1 year postdischarge. Veterans in the 99th percentile have a 74% risk for these adverse outcomes at 1 year.⁶

The Joint Commission states that a fundamental component to assuring safe and effective TOC is medication management, which includes the involvement of pharmacists.² TOC programs with pharmacist involvement have shown significant improvements related to reduced 30-day hospital readmissions and health care costs in addition to significant medication-related interventions.^7-9 While this body of evidence continues to grow and demonstrates that pharmacists are an integral component of the TOC process, there is no gold standard program. Brantley and colleagues noted that a weakness of many TOC programs is that they are one dimensional, meaning that they focus on only 1 element of care transitions or 1 specific patient population or disease.¹⁰

There is well-supported evidence of high-impact interventions for pharmacists involved early in the admission process, but data are less robust on the discharge process. ^11,12 Therefore, the primary focus of this project was to develop a pharmacist-based TOC program and implement a process for communicating high-risk patients who are discharging from our hospital across the continuum of care.

Setting

The Richard L. Roudebush VA Medical Center (RLRVAMC) is a tertiary care referral center for veterans in Indiana and eastern Illinois. Acute care clinical pharmacists are fully integrated into the acute care teams and practice under a comprehensive care model. Pharmacists attend daily patient care rounds and conduct discharge medication reconciliation for all patients with additional bedside counseling for patients who are being discharged home.

Primary care services are provided by patient aligned care teams (PACTs), multidisciplinary teams composed of physicians, advanced practice nurses, pharmacists, mental health care providers, registered nurses, dieticians, and care coordinators. Ambulatory Care or PACT clinical pharmacists are established within each RLRVAMC PACT clinic and provide comprehensive care management through an independent scope of practice for several chronic diseases, including hypertension, type 2 diabetes mellitus (T2DM), dyslipidemia, hypothyroidism, and tobacco cessation. Prior to this project implementation, there was no formalized or standardized method for facilitating routine communication of patients between acute care and PACT pharmacists in the TOC process.

Pilot Study

In 2017, RLRVAMC implemented a TOC pharmacy program pilot. A pharmacy resident and both acute care and PACT clinical pharmacy specialists (CPSs) developed the service. The pilot program was conducted from September 1, 2017 to March 1, 2018. The initial phase consisted of the development of an electronic TOC tool to standardize communication between acute care and PACT pharmacists. The TOC tool was created on a secure site accessible only to pharmacy personnel and not part of the formal medical record. (Figure 1).

The acute care pharmacist identified high-risk patients through calculated CAN and LACE scores during the discharge process and offered PACT pharmacist follow-up to the patient during bedside discharge counseling. Information was then entered into the TOC tool, including patient identifiers and a message with specific information outlining the reason for referral. PACT pharmacists routinely reviewed the tool and attempted to phone each patient within 7 days of discharge. Follow-up included medication reconciliation and chronic disease management as warranted at the discretion of the PACT pharmacist. All postdischarge follow-up appointments were created and documented in the electronic health record. A retrospective chart review was completed on patients who were entered into the TOC tool.

Patients were eligible for referral if they were discharged during the study period with primary care established in one of the facility’s PACT clinics. Additionally, patients had to meet ≥ 1 of the following criteria, deeming them a high risk for readmission: LACE score ≥ 10, CAN score ≥ 90th percentile, or be considered high risk based on the discretion of the acute care pharmacist. Patients were included in the analysis if they met the CAN or LACE score requirement. Patients were excluded if they received primary care from a site other than a RLRVAMC PACT clinic. This included non-VA primary care, home-based primary care, or VA community-based outpatient clinics (CBOCs). Patients also were excluded if they required further institutional care postdischarge (ie, subacute rehabilitation, extended care facility, etc), discharged to hospice, or against medical advice.

The average referral rate per month during the pilot study was 19 patients, with 113 total referrals during the 6-month study period. Lower rates of index emergency department (ED) visits (5.3% vs 23.3%) and readmissions (1% vs 6.7%) were seen in the group of patients who received PACT pharmacist follow-up postdischarge compared with those who did not. Additionally, PACT pharmacists were able to make > 120 interventions, averaging 1.7 interventions per patient. Of note, these results were not statistically analyzed and were assessed as observational data to determine whether the program had the potential to be impactful. The results of the pilot study demonstrated positive outcomes associated with having a pharmacist-based TOC process and led to the desire for further development and implementation of the TOC program at the RLRVAMC. These positive results prompted a second phase project to address barriers, make improvements, and ensure sustainability.

Methods

Phase 2 was a quality improvement initiative; therefore, institutional review board approval was not needed. The aim of phase 2 was to improve, expand, and sustain the TOC program that was implemented in the pilot study. Barriers identified after discussion with acute care and PACT pharmacists included difficulty in making referrals due to required entry of cumbersome readmission risk factor calculations, limiting inclusion to patients who receive primary care at the main hospital facility, and the expansion of pharmacy staff with new pharmacists who were not knowledgeable of the referral process.

Design

To overcome barriers, 4 main targeted interventions were needed: streamlining the referral process, enhancing pharmacy staff education, updating the discharge note template, and expanding the criteria to include patients who receive care at VA CBOCs. The referral process was streamlined by removing required calculated readmission risk scores, allowing pharmacist judgement to take precedence for referrals. Focused face-to-face education was provided to acute care and PACT pharmacists about the referral process and inclusion criteria to increase awareness and provide guidance of who may benefit from entry into the tool. Unlike the first phase of the study, education was provided for outpatient staff pharmacists responsible for discharging patients on the weekends. Additionally, the pharmacists received a printed quick reference guide of the information covered during the education sessions (Figure 2). Referral prompts were embedded into the standard pharmacy discharge note template to serve as a reminder to discharging pharmacists to assess patients for inclusion into the tool and provided a direct link to the tool. Expansion to include VA CBOCs occurred postpilot study, allowing increased patient access to this TOC service. All other aspects of the program were continued from the pilot phase.

Patients were eligible if they were discharged from RLRVAMC between October 1, 2018 and February 28, 2019. Additionally, the patient had to be established in a PACT clinic for primary care and have been referred to the tool based on the discretion of an acute care pharmacist. Patients were excluded if they were discharged against medical advice or to any facility where the patient and/or caregiver would not be responsible for medication administration (eg, subacute rehabilitation, extended care facility), or if the patient refused pharmacy follow-up.

Outcomes

The primary outcomes assessed were all-cause and index ED visits and readmissions within 30 days of discharge. All-cause ED visits and readmissions were defined as a second visit to RLRVAMC , regardless of readmission diagnosis. Index ED visits and readmissions were defined as those that were related to the initial admission diagnosis. Additional data collected and analyzed included the number of patients referred by pharmacists, number and type of medication discrepancies, medication changes, counseling interventions, time to follow-up postdischarge, and number of patients added to the PACT pharmacist’s clinic schedule for further management. A discrepancy identified by a PACT pharmacist was defined as a difference between the discharge medication list and the patient-reported medication list at the time of follow-up. Patients who were referred to the TOC tool but were unable to be reached by telephone served as the control group for this study.

Data Collection

A retrospective chart review was completed on patients entered into the tool. Data were collected and kept in a secured Microsoft Excel workbook. Baseline characteristics were analyzed using either a χ² for nominal data or Student t test for continuous data. The primary outcomes were analyzed using a χ² test. All statistical tests were analyzed using MiniTab 19 Statistical Software.

Results

Pharmacists added 172 patients into the TOC tool; 139 patients met inclusion criteria. Of those excluded, most were because the PACT pharmacist did not attempt to contact the patient since they already had a primary care visit scheduled postdischarge (Table 1). Of the 139 patients who met the inclusion criteria, 99 were successfully contacted by a PACT pharmacist. Most patients were aged in their 60s, male, and white. Both groups had a similar quantity of outpatient medications on admission and medication changes made at discharge. Additionally, both groups had a similar number of patients with hospitalizations and/or ED visits in the 3 months before hospital admission that resulted in TOC tool referral (Table 2).

Hospital Readmission

Hospital 30-day readmission rates for patients who were successfully followed by pharmacy compared with those who were not were 5.1% vs 15.0% (P = .049) for index readmissions and 8.1% vs 27.5% (P = .03) for all-cause readmissions. No statistically significant difference existed between those patients with follow-up compared with those without follow-up for either index (10.1% vs 12.5%, respectively; P = .68) or for all-cause ED visit rates (15.2% vs 20.0%, respectively; P = .49).

Patient Encounters

The average time to follow-up was 8.8 days, which was above the predetermined goal of contact within 7 days. Additionally, this was a decline from the initial pilot study, which had an average time to reach of 4.7 days. All patients reached by a pharmacist received medication reconciliation, with ≥ 28% of patients having ≥ 1 discrepancy. There were 43 discrepancies among all patients. Of the discrepancies, 25 were reported as errors performed by the patient, and 18 were from an error during the discharge process. The discrepancies that resulted from patient error were primarily patients who took the wrong dose of prescribed medications. Other patient discrepancies included taking medications not as scheduled, omitting medications (both intentionally and mistakenly), continuing to take medications that had been discontinued by a health care provider and improper administration technique. Examples of provider errors that occurred during the discharge process included not ordering medications for patient to pick up at discharge, not discontinuing a medication from the patient’s profile, and failure to renew expired prescriptions.

Additional counseling was provided to 75% of patients: The most common reason for counseling was T2DM, hypertension, and dyslipidemia management. PACT pharmacists changed medication regimens for 27.3% of patients for improved control of chronic diseases or relief of medication AEs.

At the end of each visit, patients were assessed to determine whether they could benefit from additional pharmacy follow-up. Thirty-seven patients were added to the pharmacist schedules for disease management appointments. The most common conditions for these appointments were T2DM, hypertension, tobacco cessation, and hyperlipidemia. Among the 37 patients who had pharmacy follow-up, there were 137 additional pharmacy appointments within the study period.

Program Referrals

After expansion to include the VA CBOCs, elimination of the elevated LACE or CAN score requirement, and additional staff education, the rate of referrals per month increased during phase 2 in comparison to the pilot study (Figure 3). There were a mean (SD) of 34 (10) referrals per month. Although not statistically analyzed, it is an objective increase in comparison to a mean 19 referrals per month in the pilot study.

Discussion

The continued development and use of a pharmacist-driven TOC tool at RLRVAMC increased communication and follow-up of high-risk patients, demonstrated the ability of pharmacists to identify and intervene in medication-related issues postdischarge, and successfully reduce 30-day readmissions. This program emphasized pharmacist involvement during the discharge process and created a standardized mechanism for TOC follow-up, addressing multiple areas that were identified by The Joint Commission as being associated with poor outcomes. The advanced pharmacy practice model at RLRVAMC allowed for a multidimensional program, including prospective patient identification and multiple pharmacy touchpoints. This is unique in comparison to many of the one-dimensional programs described in the literature.

Polypharmacy has been identified as a major predictor of medication discrepancies postdischarge, and patients with ≥ 10 active medications have been found to be at highest risk.^13,14 Patients in this study had a mean 13 active medications on admission, with a mean 5 medication changes at discharge. PACT pharmacists documented 28 of 99 patients with ≥ 1 medication-related discrepancy at postdischarge reconciliation. This 28% discrepancy rate is consistent with discrepancy rates previously reported in the literature, which ranged from 14 to 45% in large meta-analyses.^14,15 The majority of these discrepancies (58%) were related to patients who took the wrong dose of a prescribed medication.

Targeted interventions to overcome barriers in the pilot study increased the referral rates to the TOC tool; however, the increase in referral rate was associated with increased time to follow up by ambulatory care pharmacists. The extended follow-up times were seen most often in the 2 busiest primary care clinics, one of which is considered a teaching clinic for medical residents. Pharmacists were required to integrate these calls into their normal work schedule and were not provided additional time for calling, allowing for an increased follow-up time. The increased follow-up time likely contributed to the increased number of patients excluded due to already having PACT follow-up, giving more time for the primary care provider to have an appointment with the patient. The ambulatory care pharmacist could then determine whether further intervention was needed. In the summer of 2018, a decrease in referral rates occurred for a short time, but this is likely explained by incoming new residents and staff within the pharmacy department and decreased awareness among the new staff. The enhanced staff education took place during September 2018 and lead to increased referral rates compared with those seen in months prior.

PACT pharmacists were not only able to identify discrepancies, but also provide timely intervention on a multitude of medication-related issues by using their scope of practice (SOP). Most interventions were related to medication or disease counseling, including lifestyle, device, and disease education. The independent SOP of our PACT pharmacists is a unique aspect of this program and allowed pharmacists to independently adjust many aspects of a patient’s medication regimen during follow-up visits.

The outcomes of 30-day index and all-cause readmissions, as well as index and all-cause ED visit rates, were lower in the subset of patients who received PACT pharmacist follow-up after discharge (Table 3). The difference was most pronounced in the all-cause readmission rates: Only 8.1% of patients who received PACT follow-up experienced a readmission compared with 27.5% of those who did not. The difference between the groups regarding ED visit rates were not as pronounced, but this may be attributed to a limited sample size. These data indicate that the role of the pharmacist in identifying discrepancies and performing interventions at follow-up may play a clinically significant part in reducing both ED visit rates and hospital readmissions.

Limitations

There are some limitations identified within this study. Although the referral criteria were relaxed from the pilot study and enhanced education was created, continued education regarding appropriate referral of TOC patients continues to be necessary given intermittent staff changeover, incorporation of pharmacy trainees, and modifications to clinic workflow. Patients who were discharged to facilities were not included. This ensured that appropriate and consistent PACT pharmacist follow-up would be available, but likely reduced our sample size.

Although performing this study in a closed health care system with pharmacists who have independent SOPs is a strength of our study, also it can limit generalizability. Not all facilities house both acute care and ambulatory care in one location with wide SOPs to allow for comprehensive and continued care. Last, this study used convenience sampling, potentially introducing selection bias, as patients unable to be reached by PACT pharmacists may inherently be at increased risk for hospital readmission. However, in the 3 months preceding the hospital admission that resulted in TOC tool referral, both groups had a similar number of patients with hospital admissions and ED visits.

The TOC tool has become fully integrated into the daily workflow for both acute care and PACT pharmacists. After the conclusion of the study period, the referral rates into the tool have been maintained at a steady level, even surpassing the rates seen during the study period. In comparison with the pilot study, PACT pharmacists reported a subjective increase in referrals placed for procedures such as medication reconciliation or adherence checks. This is likely because acute care pharmacists were able to use their clinical judgement rather than to rely solely on calculated readmission risk scores for TOC tool referral.

The success of the TOC program led to the expansion to other specialty areas. ED pharmacists now refer patients from the ED who were not admitted to the hospital but would benefit from PACT follow-up. Additionally, the option to refer hematology and oncology patients was added to allow these patients to be followed up by our hematology/oncology CPSs by phone appointments. Unique reasons for follow-up for this patient population include concerns about delayed chemotherapy cycles or chemotherapy-associated AEs.

Conclusions

This study outlines the creation and continued improvement of a pharmacist-based TOC program. The program was designed as a method of communication between acute care and PACT pharmacists about high-risk patients. The creation of this program allowed PACT pharmacists not only to identify discrepancies and make interventions on high-risk patients, but also demonstrate that having pharmacists involved in these programs may have a positive impact on readmissions and ED visits. The success of the TOC tool at the RLRVAMC has led to its expansion and is now an integral part of the daily workflow for both acute care and PACT pharmacists.

The use of telehealth may have skyrocketed during the COVID-19 pandemic, but it also exposed a digital divide, speaker after speaker said during a panel discussion at the Society for Pediatric Dermatology (SPD) pre-AAD meeting.

“We have seen large numbers of children struggle with access to school and access to health care because of lack of access to devices, challenges of broadband Internet access, culture, language, and educational barriers – just having trouble being comfortable with this technology,” said Natalie Pageler, MD, a pediatric intensivist and chief medical information officer at Stanford Children’s Health, Palo Alto, Calif.

“There are also privacy concerns, especially in situations where there are multiple families within a household. Finally, it’s important to remember that policy and reimbursement issues may have a significant effect on some of the socioeconomic barriers,” she added. “For example, many of our families who don’t have access to audio and video may be able to do a telephone call, but it’s important that telephone calls be considered a form of telehealth and be reimbursed to help increase the access to health care by these families. It also makes it easier to facilitate coordination of care. All of this leads to decreased time and costs for patients, families, and providers.”

Within the first few weeks of the pandemic, Dr. Pageler and colleagues at Stanford Children’s Health observed an increase from about 20 telehealth visits per day to more than 700 per day, which has held stable. While the benefits of telehealth are clear, many perceived barriers exist. In a study conducted prior to the COVID-19 pandemic, researchers identified a wide variety of barriers to implementation of telehealth, led by reimbursement, followed by poor business model sustainability, lack of provider time, and provider interest.

“Some of the barriers, like patient preferences for inpatient care, lack of provider interest in telehealth, and lack of provider time were easily overcome during the COVID pandemic,” Dr. Pageler said. “We dedicated the time to train immediately, because the need was so great.”

In 2018, Patrick McMahon, MD, and colleagues at Children’s Hospital of Philadelphia, launched a teledermatology program that provided direct-to-patient “E-visits” and recently pivoted to using this service only for acne patients through a program called “Acne Express.” The out-of-pocket cost to patients is $50 per consult and nearly 1,500 cases have been completed since 2018, which has saved patients and their parents an estimated 65,000 miles driving to the clinic.

To optimize the teledermatology experience, he suggested four pillars: educate, optimize, reach out, and tailor. “I think we need to draw upon some of the digital education we already have, including a handout for patients [on the SPD website] that offers tips on taking a clear photograph on their smartphones,” he said. “We’re also trying to use some of the cases and learnings from our teledermatology experiences to teach the providers. We are setting up CME modules that are sort of a flashcard-based teaching mechanism.”

To optimize teledermatology experiences, he continued, tracking demographics, diagnoses, number of cases, and turnaround time is helpful. “We can then track who’s coming in to see us at follow-up after a new visit through telehealth,” Dr. McMahon said. “This helps us repurpose things, pivot as needed, and find any glitches. Surveying the families is also critical. Finally, we need clinical support to tee-up visits and to ensure photos are submitted and efficient, and to match diagnoses and family preference with the right modality.”

Another panelist, Justin M. Ko, MD, MBA, who chairs the American Academy of Dermatology’s Task Force on Augmented Intelligence, said that digitally enabled and artificial intelligence (AI)-augmented care delivery offers a “unique opportunity” for increasing access and increasing the value of care delivered to patients.

“The role that we play as clinicians is central, and I think we can make significant strides by doing two things,” said Dr. Ko, chief of medical dermatology for Stanford (Calif.) Health Care. “One: extending the reach of our expertise, and the second: scaling the impact of the care we deliver by clinician-driven, patient-centered, digitally-enabled, AI-augmented care delivery innovation. This opportunity for digital care transformation is more than just a transition from in-person visits to video visits. We have to look at this as an opportunity to leverage the unique aspects of digital capabilities and fundamentally reimagine how we deliver care.”

The AAD’s Position Statement on Augmented Intelligence was published in 2019.

Between March and June of 2021, Neil S. Prose, MD, conducted about 300 televisits with patients. “I had a few spectacular visits where, for example, a teenage patient who had been challenging showed me all of her artwork and we became instantly more connected,” said Dr. Prose, professor of dermatology, pediatrics, and global health at Duke University, Durham, N.C. “Then there’s the potential for a long-term improvement in health care for some patients.”

[email protected]

The use of telehealth may have skyrocketed during the COVID-19 pandemic, but it also exposed a digital divide, speaker after speaker said during a panel discussion at the Society for Pediatric Dermatology (SPD) pre-AAD meeting.

“We have seen large numbers of children struggle with access to school and access to health care because of lack of access to devices, challenges of broadband Internet access, culture, language, and educational barriers – just having trouble being comfortable with this technology,” said Natalie Pageler, MD, a pediatric intensivist and chief medical information officer at Stanford Children’s Health, Palo Alto, Calif.

“There are also privacy concerns, especially in situations where there are multiple families within a household. Finally, it’s important to remember that policy and reimbursement issues may have a significant effect on some of the socioeconomic barriers,” she added. “For example, many of our families who don’t have access to audio and video may be able to do a telephone call, but it’s important that telephone calls be considered a form of telehealth and be reimbursed to help increase the access to health care by these families. It also makes it easier to facilitate coordination of care. All of this leads to decreased time and costs for patients, families, and providers.”

Within the first few weeks of the pandemic, Dr. Pageler and colleagues at Stanford Children’s Health observed an increase from about 20 telehealth visits per day to more than 700 per day, which has held stable. While the benefits of telehealth are clear, many perceived barriers exist. In a study conducted prior to the COVID-19 pandemic, researchers identified a wide variety of barriers to implementation of telehealth, led by reimbursement, followed by poor business model sustainability, lack of provider time, and provider interest.

“Some of the barriers, like patient preferences for inpatient care, lack of provider interest in telehealth, and lack of provider time were easily overcome during the COVID pandemic,” Dr. Pageler said. “We dedicated the time to train immediately, because the need was so great.”

In 2018, Patrick McMahon, MD, and colleagues at Children’s Hospital of Philadelphia, launched a teledermatology program that provided direct-to-patient “E-visits” and recently pivoted to using this service only for acne patients through a program called “Acne Express.” The out-of-pocket cost to patients is $50 per consult and nearly 1,500 cases have been completed since 2018, which has saved patients and their parents an estimated 65,000 miles driving to the clinic.

To optimize the teledermatology experience, he suggested four pillars: educate, optimize, reach out, and tailor. “I think we need to draw upon some of the digital education we already have, including a handout for patients [on the SPD website] that offers tips on taking a clear photograph on their smartphones,” he said. “We’re also trying to use some of the cases and learnings from our teledermatology experiences to teach the providers. We are setting up CME modules that are sort of a flashcard-based teaching mechanism.”

To optimize teledermatology experiences, he continued, tracking demographics, diagnoses, number of cases, and turnaround time is helpful. “We can then track who’s coming in to see us at follow-up after a new visit through telehealth,” Dr. McMahon said. “This helps us repurpose things, pivot as needed, and find any glitches. Surveying the families is also critical. Finally, we need clinical support to tee-up visits and to ensure photos are submitted and efficient, and to match diagnoses and family preference with the right modality.”

Another panelist, Justin M. Ko, MD, MBA, who chairs the American Academy of Dermatology’s Task Force on Augmented Intelligence, said that digitally enabled and artificial intelligence (AI)-augmented care delivery offers a “unique opportunity” for increasing access and increasing the value of care delivered to patients.

“The role that we play as clinicians is central, and I think we can make significant strides by doing two things,” said Dr. Ko, chief of medical dermatology for Stanford (Calif.) Health Care. “One: extending the reach of our expertise, and the second: scaling the impact of the care we deliver by clinician-driven, patient-centered, digitally-enabled, AI-augmented care delivery innovation. This opportunity for digital care transformation is more than just a transition from in-person visits to video visits. We have to look at this as an opportunity to leverage the unique aspects of digital capabilities and fundamentally reimagine how we deliver care.”

The AAD’s Position Statement on Augmented Intelligence was published in 2019.

Between March and June of 2021, Neil S. Prose, MD, conducted about 300 televisits with patients. “I had a few spectacular visits where, for example, a teenage patient who had been challenging showed me all of her artwork and we became instantly more connected,” said Dr. Prose, professor of dermatology, pediatrics, and global health at Duke University, Durham, N.C. “Then there’s the potential for a long-term improvement in health care for some patients.”

[email protected]

The use of telehealth may have skyrocketed during the COVID-19 pandemic, but it also exposed a digital divide, speaker after speaker said during a panel discussion at the Society for Pediatric Dermatology (SPD) pre-AAD meeting.

“We have seen large numbers of children struggle with access to school and access to health care because of lack of access to devices, challenges of broadband Internet access, culture, language, and educational barriers – just having trouble being comfortable with this technology,” said Natalie Pageler, MD, a pediatric intensivist and chief medical information officer at Stanford Children’s Health, Palo Alto, Calif.

“There are also privacy concerns, especially in situations where there are multiple families within a household. Finally, it’s important to remember that policy and reimbursement issues may have a significant effect on some of the socioeconomic barriers,” she added. “For example, many of our families who don’t have access to audio and video may be able to do a telephone call, but it’s important that telephone calls be considered a form of telehealth and be reimbursed to help increase the access to health care by these families. It also makes it easier to facilitate coordination of care. All of this leads to decreased time and costs for patients, families, and providers.”

Within the first few weeks of the pandemic, Dr. Pageler and colleagues at Stanford Children’s Health observed an increase from about 20 telehealth visits per day to more than 700 per day, which has held stable. While the benefits of telehealth are clear, many perceived barriers exist. In a study conducted prior to the COVID-19 pandemic, researchers identified a wide variety of barriers to implementation of telehealth, led by reimbursement, followed by poor business model sustainability, lack of provider time, and provider interest.

“Some of the barriers, like patient preferences for inpatient care, lack of provider interest in telehealth, and lack of provider time were easily overcome during the COVID pandemic,” Dr. Pageler said. “We dedicated the time to train immediately, because the need was so great.”

In 2018, Patrick McMahon, MD, and colleagues at Children’s Hospital of Philadelphia, launched a teledermatology program that provided direct-to-patient “E-visits” and recently pivoted to using this service only for acne patients through a program called “Acne Express.” The out-of-pocket cost to patients is $50 per consult and nearly 1,500 cases have been completed since 2018, which has saved patients and their parents an estimated 65,000 miles driving to the clinic.

To optimize the teledermatology experience, he suggested four pillars: educate, optimize, reach out, and tailor. “I think we need to draw upon some of the digital education we already have, including a handout for patients [on the SPD website] that offers tips on taking a clear photograph on their smartphones,” he said. “We’re also trying to use some of the cases and learnings from our teledermatology experiences to teach the providers. We are setting up CME modules that are sort of a flashcard-based teaching mechanism.”

To optimize teledermatology experiences, he continued, tracking demographics, diagnoses, number of cases, and turnaround time is helpful. “We can then track who’s coming in to see us at follow-up after a new visit through telehealth,” Dr. McMahon said. “This helps us repurpose things, pivot as needed, and find any glitches. Surveying the families is also critical. Finally, we need clinical support to tee-up visits and to ensure photos are submitted and efficient, and to match diagnoses and family preference with the right modality.”

Another panelist, Justin M. Ko, MD, MBA, who chairs the American Academy of Dermatology’s Task Force on Augmented Intelligence, said that digitally enabled and artificial intelligence (AI)-augmented care delivery offers a “unique opportunity” for increasing access and increasing the value of care delivered to patients.

“The role that we play as clinicians is central, and I think we can make significant strides by doing two things,” said Dr. Ko, chief of medical dermatology for Stanford (Calif.) Health Care. “One: extending the reach of our expertise, and the second: scaling the impact of the care we deliver by clinician-driven, patient-centered, digitally-enabled, AI-augmented care delivery innovation. This opportunity for digital care transformation is more than just a transition from in-person visits to video visits. We have to look at this as an opportunity to leverage the unique aspects of digital capabilities and fundamentally reimagine how we deliver care.”

The AAD’s Position Statement on Augmented Intelligence was published in 2019.

Between March and June of 2021, Neil S. Prose, MD, conducted about 300 televisits with patients. “I had a few spectacular visits where, for example, a teenage patient who had been challenging showed me all of her artwork and we became instantly more connected,” said Dr. Prose, professor of dermatology, pediatrics, and global health at Duke University, Durham, N.C. “Then there’s the potential for a long-term improvement in health care for some patients.”

[email protected]

A 57-year-old woman with a history of traumatic brain injury, posttraumatic stress disorder, depression, migraines, hypothyroidism, and a hiatal hernia repair presented to the emergency department with a 1-day history of nausea, vomiting, and diffuse abdominal pain. She reported that her symptoms were relieved by hot showers. She also reported having similar symptoms and a previous gastric-emptying study that showed a slow-emptying stomach. Her history also consisted of frequent cannabis use for mood and appetite stimulation along with eliminating meat and fish from her diet, an increase in consumption of simple carbohydrates in the past year, and no alcohol use. Her medications included topiramate 100 mg and clonidine 0.3 mg nightly for migraines; levothyroxine 200 mcg daily for hypothyroidism; tizanidine 4 mg twice a day for muscle spasm; famotidine 40 mg twice a day as needed for gastric reflux; and bupropion 50 mg daily, citalopram 20 mg daily, and lamotrigine 25 mg nightly for mood.

The patient’s physical examination was notable for bradycardia (43 beats/min) and epigastric tenderness. Admission laboratory results were notable for an elevated lactic acid level of 4.8 (normal range, 0.50-2.20) mmol/L and a leukocytosis count of 10.8×10⁹ cells/L. Serum alcohol level and blood cultures were negative. Liver function test, hemoglobin A_1c, and lipase test were unremarkable. Her electrocardiogram showed an unchanged right bundle branch block. Chest X-ray, computed tomography (CT) of her abdomen/pelvis and echocardiogram were unremarkable.

What is your diagnosis? 

How would you treat this patient? 

This patient was diagnosed with gastrointestinal beriberi. Because of her dietary changes, lactic acidosis, and bradycardia, thiamine deficiency was suspected after ruling out other possibilities on the differential diagnosis (Table). The patient’s symptoms resolved after administration of high-dose IV thiamine 500 mg 3 times daily for 4 days. Her white blood cell count and lactic acid level normalized. Unfortunately, thiamine levels were not obtained for the patient before treatment was initiated. After administration of IV thiamine, her plasma thiamine level was > 1,200 (normal range, 8-30) nmol/L.

Her differential diagnosis included infectious etiology. Given her leukocytosis and lactic acidosis, vancomycin and piperacillin/tazobactam were started on admission. One day later, her leukocytosis count doubled to 20.7×10⁹ cells/L. However, after 48 hours of negative blood cultures, antibiotics were discontinued.

Small bowel obstruction was suspected due to the patient’s history of abdominal surgery but was ruled out with CT imaging. Similarly, pancreatitis was ruled out based on negative CT imaging and the patient’s normal lipase level. Gastroparesis also was considered because of the patient’s history of hypothyroidism, tobacco use, and her prior gastric-emptying study. The patient was treated for gastroparesis with a course of metoclopramide and erythromycin without improvement in symptoms. Additionally, gastroparesis would not explain the patient’s leukocytosis.

Cannabinoid hyperemesis syndrome (CHS) was suspected because the patient’s symptoms improved with cannabis discontinuation and hot showers.¹ In chronic users, however, tetrahydrocannabinol levels have a half-life of 5 to 13 days.² Although lactic acidosis and leukocytosis have been previously reported with cannabis use, it is unlikely that the patient would have such significant improvement within the first 4 days after discontinuation.^1,3,4 Although the patient had many psychiatric comorbidities with previous hospitalizations describing concern for somatization disorder, her leukocytosis and elevated lactic acid levels were suggestive of an organic rather than a psychiatric etiology of her symptoms.

Discussion

Gastrointestinal beriberi has been reported in chronic cannabis users who present with nausea, vomiting, epigastric pain, leukocytosis, and lactic acidosis; all these symptoms rapidly improve after thiamine administration.^5,6 The patient’s dietary change also eliminated her intake of vitamin B₁₂, which compounded her condition. Thiamine deficiency produces lactic acidosis by disrupting pyruvate metabolism.⁷ Bradycardia also can be a sign of thiamine deficiency, although the patient’s use of clonidine for migraines is a confounder.⁸

Chronically ill patients are prone to nutritional deficiencies, including deficiencies of thiamine.^7,9 Many patients with chronic illnesses also use cannabis to ameliorate physical and neuropsychiatric symptoms.² Recent reports suggest cannabis users are prone to gastrointestinal beriberi and Wernicke encephalopathy.^5,10 Treating gastrointestinal symptoms in these patients can be challenging to diagnose because gastrointestinal beriberi and CHS share many clinical manifestations.

The patient’s presentation is likely multifactorial resulting from the combination of gastrointestinal beriberi and CHS. However, thiamine deficiency seems to play the dominant role.

There is no standard treatment regimen for thiamine deficiency with neurologic deficits, and patients only retain about 10 to 15% of intramuscular (IM) injections of cyanocobalamin.^11,12 The British Committee for Standards in Haematology recommends IM injections of 1,000 mcg of cyanocobalamin 3 times a week for 2 weeks and then reassess the need for continued treatment.¹³ The British Columbia guidelines also recommend IM injections of 1,000 mcg daily for 1 to 5 days before transitioning to oral repletion.¹⁴ European Neurology guidelines for the treatment of Wernicke encephalopathy recommend IV cyanocobalamin 200 mg 3 times daily.¹⁵ Low-level evidence with observational studies informs these decisions and is why there is variation.

The patient’s serum lactate and leukocytosis normalized 1 day after the administration of thiamine. Thiamine deficiency classically causes Wernicke encephalopathy and wet beriberi.¹⁶ The patient did not present with Wernicke encephalopathy’s triad: ophthalmoplegia, ataxia, or confusion. She also was euvolemic without signs or symptoms of wet beriberi.

Conclusions

Thiamine deficiency is principally a clinical diagnosis. Thiamine laboratory testing may not be readily available in all medical centers, and confirming a diagnosis of thiamine deficiency should not delay treatment when thiamine deficiency is suspected. This patient’s thiamine levels resulted a week after collection. The administration of thiamine before sampling also can alter the result as it did in this case. Additionally, laboratories may offer whole blood and serum testing. Whole blood testing is more accurate because most bioactive thiamine is found in red blood cells.¹⁷

A 57-year-old woman with a history of traumatic brain injury, posttraumatic stress disorder, depression, migraines, hypothyroidism, and a hiatal hernia repair presented to the emergency department with a 1-day history of nausea, vomiting, and diffuse abdominal pain. She reported that her symptoms were relieved by hot showers. She also reported having similar symptoms and a previous gastric-emptying study that showed a slow-emptying stomach. Her history also consisted of frequent cannabis use for mood and appetite stimulation along with eliminating meat and fish from her diet, an increase in consumption of simple carbohydrates in the past year, and no alcohol use. Her medications included topiramate 100 mg and clonidine 0.3 mg nightly for migraines; levothyroxine 200 mcg daily for hypothyroidism; tizanidine 4 mg twice a day for muscle spasm; famotidine 40 mg twice a day as needed for gastric reflux; and bupropion 50 mg daily, citalopram 20 mg daily, and lamotrigine 25 mg nightly for mood.

The patient’s physical examination was notable for bradycardia (43 beats/min) and epigastric tenderness. Admission laboratory results were notable for an elevated lactic acid level of 4.8 (normal range, 0.50-2.20) mmol/L and a leukocytosis count of 10.8×10⁹ cells/L. Serum alcohol level and blood cultures were negative. Liver function test, hemoglobin A_1c, and lipase test were unremarkable. Her electrocardiogram showed an unchanged right bundle branch block. Chest X-ray, computed tomography (CT) of her abdomen/pelvis and echocardiogram were unremarkable.

What is your diagnosis? 

How would you treat this patient? 

This patient was diagnosed with gastrointestinal beriberi. Because of her dietary changes, lactic acidosis, and bradycardia, thiamine deficiency was suspected after ruling out other possibilities on the differential diagnosis (Table). The patient’s symptoms resolved after administration of high-dose IV thiamine 500 mg 3 times daily for 4 days. Her white blood cell count and lactic acid level normalized. Unfortunately, thiamine levels were not obtained for the patient before treatment was initiated. After administration of IV thiamine, her plasma thiamine level was > 1,200 (normal range, 8-30) nmol/L.

Her differential diagnosis included infectious etiology. Given her leukocytosis and lactic acidosis, vancomycin and piperacillin/tazobactam were started on admission. One day later, her leukocytosis count doubled to 20.7×10⁹ cells/L. However, after 48 hours of negative blood cultures, antibiotics were discontinued.

Small bowel obstruction was suspected due to the patient’s history of abdominal surgery but was ruled out with CT imaging. Similarly, pancreatitis was ruled out based on negative CT imaging and the patient’s normal lipase level. Gastroparesis also was considered because of the patient’s history of hypothyroidism, tobacco use, and her prior gastric-emptying study. The patient was treated for gastroparesis with a course of metoclopramide and erythromycin without improvement in symptoms. Additionally, gastroparesis would not explain the patient’s leukocytosis.

Cannabinoid hyperemesis syndrome (CHS) was suspected because the patient’s symptoms improved with cannabis discontinuation and hot showers.¹ In chronic users, however, tetrahydrocannabinol levels have a half-life of 5 to 13 days.² Although lactic acidosis and leukocytosis have been previously reported with cannabis use, it is unlikely that the patient would have such significant improvement within the first 4 days after discontinuation.^1,3,4 Although the patient had many psychiatric comorbidities with previous hospitalizations describing concern for somatization disorder, her leukocytosis and elevated lactic acid levels were suggestive of an organic rather than a psychiatric etiology of her symptoms.

Discussion

Gastrointestinal beriberi has been reported in chronic cannabis users who present with nausea, vomiting, epigastric pain, leukocytosis, and lactic acidosis; all these symptoms rapidly improve after thiamine administration.^5,6 The patient’s dietary change also eliminated her intake of vitamin B₁₂, which compounded her condition. Thiamine deficiency produces lactic acidosis by disrupting pyruvate metabolism.⁷ Bradycardia also can be a sign of thiamine deficiency, although the patient’s use of clonidine for migraines is a confounder.⁸

Chronically ill patients are prone to nutritional deficiencies, including deficiencies of thiamine.^7,9 Many patients with chronic illnesses also use cannabis to ameliorate physical and neuropsychiatric symptoms.² Recent reports suggest cannabis users are prone to gastrointestinal beriberi and Wernicke encephalopathy.^5,10 Treating gastrointestinal symptoms in these patients can be challenging to diagnose because gastrointestinal beriberi and CHS share many clinical manifestations.

The patient’s presentation is likely multifactorial resulting from the combination of gastrointestinal beriberi and CHS. However, thiamine deficiency seems to play the dominant role.

There is no standard treatment regimen for thiamine deficiency with neurologic deficits, and patients only retain about 10 to 15% of intramuscular (IM) injections of cyanocobalamin.^11,12 The British Committee for Standards in Haematology recommends IM injections of 1,000 mcg of cyanocobalamin 3 times a week for 2 weeks and then reassess the need for continued treatment.¹³ The British Columbia guidelines also recommend IM injections of 1,000 mcg daily for 1 to 5 days before transitioning to oral repletion.¹⁴ European Neurology guidelines for the treatment of Wernicke encephalopathy recommend IV cyanocobalamin 200 mg 3 times daily.¹⁵ Low-level evidence with observational studies informs these decisions and is why there is variation.

The patient’s serum lactate and leukocytosis normalized 1 day after the administration of thiamine. Thiamine deficiency classically causes Wernicke encephalopathy and wet beriberi.¹⁶ The patient did not present with Wernicke encephalopathy’s triad: ophthalmoplegia, ataxia, or confusion. She also was euvolemic without signs or symptoms of wet beriberi.

Conclusions

Thiamine deficiency is principally a clinical diagnosis. Thiamine laboratory testing may not be readily available in all medical centers, and confirming a diagnosis of thiamine deficiency should not delay treatment when thiamine deficiency is suspected. This patient’s thiamine levels resulted a week after collection. The administration of thiamine before sampling also can alter the result as it did in this case. Additionally, laboratories may offer whole blood and serum testing. Whole blood testing is more accurate because most bioactive thiamine is found in red blood cells.¹⁷

A 57-year-old woman with a history of traumatic brain injury, posttraumatic stress disorder, depression, migraines, hypothyroidism, and a hiatal hernia repair presented to the emergency department with a 1-day history of nausea, vomiting, and diffuse abdominal pain. She reported that her symptoms were relieved by hot showers. She also reported having similar symptoms and a previous gastric-emptying study that showed a slow-emptying stomach. Her history also consisted of frequent cannabis use for mood and appetite stimulation along with eliminating meat and fish from her diet, an increase in consumption of simple carbohydrates in the past year, and no alcohol use. Her medications included topiramate 100 mg and clonidine 0.3 mg nightly for migraines; levothyroxine 200 mcg daily for hypothyroidism; tizanidine 4 mg twice a day for muscle spasm; famotidine 40 mg twice a day as needed for gastric reflux; and bupropion 50 mg daily, citalopram 20 mg daily, and lamotrigine 25 mg nightly for mood.

The patient’s physical examination was notable for bradycardia (43 beats/min) and epigastric tenderness. Admission laboratory results were notable for an elevated lactic acid level of 4.8 (normal range, 0.50-2.20) mmol/L and a leukocytosis count of 10.8×10⁹ cells/L. Serum alcohol level and blood cultures were negative. Liver function test, hemoglobin A_1c, and lipase test were unremarkable. Her electrocardiogram showed an unchanged right bundle branch block. Chest X-ray, computed tomography (CT) of her abdomen/pelvis and echocardiogram were unremarkable.

What is your diagnosis? 

How would you treat this patient? 

This patient was diagnosed with gastrointestinal beriberi. Because of her dietary changes, lactic acidosis, and bradycardia, thiamine deficiency was suspected after ruling out other possibilities on the differential diagnosis (Table). The patient’s symptoms resolved after administration of high-dose IV thiamine 500 mg 3 times daily for 4 days. Her white blood cell count and lactic acid level normalized. Unfortunately, thiamine levels were not obtained for the patient before treatment was initiated. After administration of IV thiamine, her plasma thiamine level was > 1,200 (normal range, 8-30) nmol/L.

Her differential diagnosis included infectious etiology. Given her leukocytosis and lactic acidosis, vancomycin and piperacillin/tazobactam were started on admission. One day later, her leukocytosis count doubled to 20.7×10⁹ cells/L. However, after 48 hours of negative blood cultures, antibiotics were discontinued.

Small bowel obstruction was suspected due to the patient’s history of abdominal surgery but was ruled out with CT imaging. Similarly, pancreatitis was ruled out based on negative CT imaging and the patient’s normal lipase level. Gastroparesis also was considered because of the patient’s history of hypothyroidism, tobacco use, and her prior gastric-emptying study. The patient was treated for gastroparesis with a course of metoclopramide and erythromycin without improvement in symptoms. Additionally, gastroparesis would not explain the patient’s leukocytosis.

Cannabinoid hyperemesis syndrome (CHS) was suspected because the patient’s symptoms improved with cannabis discontinuation and hot showers.¹ In chronic users, however, tetrahydrocannabinol levels have a half-life of 5 to 13 days.² Although lactic acidosis and leukocytosis have been previously reported with cannabis use, it is unlikely that the patient would have such significant improvement within the first 4 days after discontinuation.^1,3,4 Although the patient had many psychiatric comorbidities with previous hospitalizations describing concern for somatization disorder, her leukocytosis and elevated lactic acid levels were suggestive of an organic rather than a psychiatric etiology of her symptoms.

Discussion

Gastrointestinal beriberi has been reported in chronic cannabis users who present with nausea, vomiting, epigastric pain, leukocytosis, and lactic acidosis; all these symptoms rapidly improve after thiamine administration.^5,6 The patient’s dietary change also eliminated her intake of vitamin B₁₂, which compounded her condition. Thiamine deficiency produces lactic acidosis by disrupting pyruvate metabolism.⁷ Bradycardia also can be a sign of thiamine deficiency, although the patient’s use of clonidine for migraines is a confounder.⁸

Chronically ill patients are prone to nutritional deficiencies, including deficiencies of thiamine.^7,9 Many patients with chronic illnesses also use cannabis to ameliorate physical and neuropsychiatric symptoms.² Recent reports suggest cannabis users are prone to gastrointestinal beriberi and Wernicke encephalopathy.^5,10 Treating gastrointestinal symptoms in these patients can be challenging to diagnose because gastrointestinal beriberi and CHS share many clinical manifestations.

The patient’s presentation is likely multifactorial resulting from the combination of gastrointestinal beriberi and CHS. However, thiamine deficiency seems to play the dominant role.

There is no standard treatment regimen for thiamine deficiency with neurologic deficits, and patients only retain about 10 to 15% of intramuscular (IM) injections of cyanocobalamin.^11,12 The British Committee for Standards in Haematology recommends IM injections of 1,000 mcg of cyanocobalamin 3 times a week for 2 weeks and then reassess the need for continued treatment.¹³ The British Columbia guidelines also recommend IM injections of 1,000 mcg daily for 1 to 5 days before transitioning to oral repletion.¹⁴ European Neurology guidelines for the treatment of Wernicke encephalopathy recommend IV cyanocobalamin 200 mg 3 times daily.¹⁵ Low-level evidence with observational studies informs these decisions and is why there is variation.

The patient’s serum lactate and leukocytosis normalized 1 day after the administration of thiamine. Thiamine deficiency classically causes Wernicke encephalopathy and wet beriberi.¹⁶ The patient did not present with Wernicke encephalopathy’s triad: ophthalmoplegia, ataxia, or confusion. She also was euvolemic without signs or symptoms of wet beriberi.

Conclusions

Thiamine deficiency is principally a clinical diagnosis. Thiamine laboratory testing may not be readily available in all medical centers, and confirming a diagnosis of thiamine deficiency should not delay treatment when thiamine deficiency is suspected. This patient’s thiamine levels resulted a week after collection. The administration of thiamine before sampling also can alter the result as it did in this case. Additionally, laboratories may offer whole blood and serum testing. Whole blood testing is more accurate because most bioactive thiamine is found in red blood cells.¹⁷

In less than a year, COVID-19 has infected nearly 100 million people worldwide and caused more than 2 million deaths and counting. Although the infection fatality rate is estimated to be 1% and the case fatality rate between 2% and 3%, COVID-19 has had a disproportionate effect on the older population and those with comorbidities. Some of these findings are mirrored in the US Department of Veterans Affairs (VA) population, which has seen a higher case fatality rate.^1-4

As a respiratory tract infection, the most dreaded presentation is severe pneumonia with acute hypoxemia, which may rapidly deteriorate to acute respiratory distress syndrome (ARDS) and respiratory failure.^5-7 This possibility has led to early intubation strategies aimed at preempting this rapid deterioration and minimizing viral exposure to health care workers. Intubation rates have varied widely with extremes of 6 to 88%.^8,9

However, this early intubation strategy has waned as some of the rationale behind its endorsement has been called into question. Early intubation bypasses alternatives to intubation; high-flow nasal cannula oxygen, noninvasive ventilation, and awake proning are all effective maneuvers in the appropriate patient.^10,11 The use of first-line high-flow nasal cannula oxygen and noninvasive ventilation has been widely reported. Reports of first-line use of high-flow nasal cannula oxygen has not demonstrated inferior outcomes, nor has the timing of intubation, suggesting a significant portion of patients could benefit from a trial of therapy and eventually avoid intubation.^11-14 Other therapies, such as systemic corticosteroids, confer a mortality benefit in those patients with COVID-19 who require oxygen or mechanical ventilation, but their impact on the progression of respiratory failure and need for intubation are undetermined.

There also are reports of patients who report no signs of respiratory distress or dyspnea with their COVID-19 pneumonia despite profound hypoxemia or high oxygen requirements. Various terms, including silent hypoxemia or happy hypoxia, are descriptive of the demeanor of these patients, and treatment has invariably included oxygen.^15,16 Nevertheless, low oxygen measurements have generally prompted higher levels of supplemental oxygen or more invasive therapies.

Treatment rendered may obscure the trajectory of response, which is important to understand to better position options for invasive therapies and other therapeutics. We recently encountered a patient with a course of illness that represented the natural history of COVID-19 pneumonia with low oxygen levels (referred to as hypoxemia for consistency) that highlighted several issues of management.

Case Presentation

A 62-year-old undomiciled woman with morbid obesity, prediabetes mellitus, long-standing schizophrenia, and bipolar disorder presented to our facility for evaluation of dry cough and need for tuberculosis clearance for admittance to a shelter. She appeared comfortable and was afebrile with blood pressure 111/74 mm Hg, heart rate 82 beats per minute. Her respiratory rate was 18 breaths per minute, but the pulse oximetry showed oxygen saturation of 70 to 75% on room air at rest. A chest X-ray showed bibasilar infiltrates (Figure 1), and a rapid COVID-19 nasopharyngeal polymerase chain reaction (PCR) test returned positive, confirmed by a second PCR test. Baseline inflammatory markers were elevated (Figure 2). In addition, the serum interleukin-6 also was elevated to 66.1 pg/mL (normal < 5.0), erythrocyte sedimentation rate elevated to 69 mm/h, but serum procalcitonin was essentially normal (0.22 ng/mL; normal < 20 ng/mL) as was the serum lactate (1.4 mmol/L).

The patient was admitted to the intensive care unit (ICU) for close monitoring in anticipation of the possibility of decompensation based on her age, hypoxia, and elevated inflammatory markers.¹⁷ Besides a subsequent low-grade fever (100.4 oF) and lymphopenia (manual count 550/uL), she remained clinically unchanged. Throughout her hospitalization, she maintained a persistent psychotic delusion that she did not have COVID-19, refusing all medical interventions, including a peripheral IV line and supplemental oxygen for the entire duration. Extensive efforts to identify family or a surrogate decision maker were unsuccessful. After consultation with Psychiatry, Bio-Ethics, and hospital leadership, the patient was deemed to lack decision-making capacity regarding treatment or disposition and was placed on a psychiatric hold. However, since any interventions against her will would require sedation, IV access, and potentially increase the risk of nosocomial COVID-19 transmission, she was allowed to remain untreated and was closely monitored for symptoms of worsening respiratory failure.

Discussion

The initial reports of COVID-19 pneumonia focused on ARDS and respiratory failure requiring mechanical ventilation with less emphasis on those with lower severity of illness. This was heightened by health care systems that were overwhelmed with large number of patients while faced with limited supplies and equipment. Given the risk to patients and providers of crash intubations, some recommended early intubation strategies.³ However, the natural history of COVID-19 pneumonia and the threshold for intubation of these patients remain poorly defined despite the creation of prognostic tools.¹⁷ This patient’s persistent hypoxemia and elevated inflammatory markers certainly met markers of disease associated with a high risk of progression.

The greatest concern would have been her level of hypoxemia. Acceptable thresholds of hypoxemia vary, but general consensus would classify pulse oximetry < 90% as hypoxemia and a threshold for administering supplemental oxygen. It is important to recognize how pulse oximetry readings translate to partial pressure of oxygen (PaO₂) measurements (Table 1). Pulse oximetry readings of 90% corresponds to a PaO₂ readings of 60 mm Hg in ideal conditions without the influence of acidosis, PaCO₂, or temperature. While lower readings are of concern, these do not represent absolute indications for assisted ventilatory support as lower levels are well tolerated in a variety of conditions. A common example are patients with chronic obstructive pulmonary disease. Long-term mortality benefits of continuous supplemental oxygen are well established in specific populations, but the threshold for correction in the acute setting remains a case-by-case decision. This decision is complex and is based on more than an absolute number or the amount of oxygen required to achieve a threshold level of oxygenation.

The severity of hypoxemia manifested by this patient may have elicited additional findings of respiratory distress, such as dyspnea and tachypnea. However, in patients with severe COVID-19 pneumonia, dyspnea was not a universal finding, reported in the 20 to 60% range of cohorts, higher in those with ARDS and mechanical ventilation, although some report near universal dyspnea in their series.^1,4,8,22,23 Tachypnea is another symptom of interest. Using a threshold of > 24 breaths/min, tachypnea was noted in 16 to 29% of patients with a much greater proportion (63%) in nonsurvivors.^6,24 Several explanations have been proposed for the discordance between the presence and severity of hypoxemia and lack of symptoms of dyspnea and tachypnea. It is important to recognize that misclassification of the severity of hypoxemia can occur due to technical issues and potential errors involving pulse oximetry measurement and shifts in the oxyhemoglobin dissociation curve. However, this is more pertinent for those with mild disease as the severity of hypoxemia in severe pneumonia is beyond what can be attributed to technical issues.

More important, the ventilatory response curve to hypoxemia may not be normal for some patients, blunted by as much as 50% in older patients, especially in those with diabetes mellitus.^7,25,26 In addition, the ventilatory response varies widely even among normal individuals. This would translate to lower levels of minute ventilation (less tachypnea or respiratory effort) with hypoxemia. Hypocapnic hypoxemia also blunts the ventilatory response to hypoxemia. Subjects do not increase their minute ventilation if the PaCO₂ remains low despite oxygen desaturation to < 70%, especially if PaCO₂ < 30 mm Hg or alternatively, increases in minute ventilation are not seen until the PaCO₂ exceeds 39 mm Hg.²⁷ Both scenarios occur in those with COVID-19 pneumonia and provide another explanation for the absence of respiratory symptoms or signs of respiratory distress in some patients.

The observation of more compliant lungs may help in the understanding of the variable presentation of these patients. Compliant lungs do not require the increased pressure needed to achieve a specific tidal volume that, in turn, may increase the work of breathing. This may add to the explanation of seemingly paradoxical silent hypoxemia in those patients where the combination of a blunted ventilatory response, hypocapnia, shunt physiology, and normal respiratory system compliance is represented by the absence of increased breathing effort despite severe hypoxemia.

If not for the patient’s refusal of medical services, this patient quite possibly would have been intubated due to hypoxemia and health care providers’ concern for her risk of deterioration. Reported intubation and mechanical ventilation rates have varied widely from extremes of from < 5 to 88% in severely ill patients.^9,22 About 75% will need oxygen, but many can be treated and recover without the need for intubation and mechanical ventilation.

As previously mentioned, options for treatment include standard and high-flow oxygen delivery, noninvasive ventilation, and awake prone ventilation. Their role in patient management has been recently outlined, and instead of an early intubation strategy, represents gradual escalation of support that may be sufficient to treat hypoxemia and avoid the need for intubation and mechanical ventilation (Table 2).

Conclusions

Since the emergence of the COVID-19, evidence has accumulated for the benefit of several adjunctive therapies in the treatment of this type of pneumonia, with corticosteroids providing a mortality benefit. Although unknown whether this patient’s experience can be generalized to others or whether it represents her unique response, this case provides another perspective for comparison of treatments and reinforces the need for prospective, randomized clinical trials to establish treatment efficacy. The exact nature of silent hypoxemia of COVID-19 remains incompletely understood; however, this case highlights the importance of treating the individual instead of clinical markers and provides a time course for recovery from pneumonia and severe hypoxemia that occurs without oxygen or any other treatment over about 2 weeks.

In less than a year, COVID-19 has infected nearly 100 million people worldwide and caused more than 2 million deaths and counting. Although the infection fatality rate is estimated to be 1% and the case fatality rate between 2% and 3%, COVID-19 has had a disproportionate effect on the older population and those with comorbidities. Some of these findings are mirrored in the US Department of Veterans Affairs (VA) population, which has seen a higher case fatality rate.^1-4

As a respiratory tract infection, the most dreaded presentation is severe pneumonia with acute hypoxemia, which may rapidly deteriorate to acute respiratory distress syndrome (ARDS) and respiratory failure.^5-7 This possibility has led to early intubation strategies aimed at preempting this rapid deterioration and minimizing viral exposure to health care workers. Intubation rates have varied widely with extremes of 6 to 88%.^8,9

However, this early intubation strategy has waned as some of the rationale behind its endorsement has been called into question. Early intubation bypasses alternatives to intubation; high-flow nasal cannula oxygen, noninvasive ventilation, and awake proning are all effective maneuvers in the appropriate patient.^10,11 The use of first-line high-flow nasal cannula oxygen and noninvasive ventilation has been widely reported. Reports of first-line use of high-flow nasal cannula oxygen has not demonstrated inferior outcomes, nor has the timing of intubation, suggesting a significant portion of patients could benefit from a trial of therapy and eventually avoid intubation.^11-14 Other therapies, such as systemic corticosteroids, confer a mortality benefit in those patients with COVID-19 who require oxygen or mechanical ventilation, but their impact on the progression of respiratory failure and need for intubation are undetermined.

There also are reports of patients who report no signs of respiratory distress or dyspnea with their COVID-19 pneumonia despite profound hypoxemia or high oxygen requirements. Various terms, including silent hypoxemia or happy hypoxia, are descriptive of the demeanor of these patients, and treatment has invariably included oxygen.^15,16 Nevertheless, low oxygen measurements have generally prompted higher levels of supplemental oxygen or more invasive therapies.

Treatment rendered may obscure the trajectory of response, which is important to understand to better position options for invasive therapies and other therapeutics. We recently encountered a patient with a course of illness that represented the natural history of COVID-19 pneumonia with low oxygen levels (referred to as hypoxemia for consistency) that highlighted several issues of management.

Case Presentation

A 62-year-old undomiciled woman with morbid obesity, prediabetes mellitus, long-standing schizophrenia, and bipolar disorder presented to our facility for evaluation of dry cough and need for tuberculosis clearance for admittance to a shelter. She appeared comfortable and was afebrile with blood pressure 111/74 mm Hg, heart rate 82 beats per minute. Her respiratory rate was 18 breaths per minute, but the pulse oximetry showed oxygen saturation of 70 to 75% on room air at rest. A chest X-ray showed bibasilar infiltrates (Figure 1), and a rapid COVID-19 nasopharyngeal polymerase chain reaction (PCR) test returned positive, confirmed by a second PCR test. Baseline inflammatory markers were elevated (Figure 2). In addition, the serum interleukin-6 also was elevated to 66.1 pg/mL (normal < 5.0), erythrocyte sedimentation rate elevated to 69 mm/h, but serum procalcitonin was essentially normal (0.22 ng/mL; normal < 20 ng/mL) as was the serum lactate (1.4 mmol/L).

The patient was admitted to the intensive care unit (ICU) for close monitoring in anticipation of the possibility of decompensation based on her age, hypoxia, and elevated inflammatory markers.¹⁷ Besides a subsequent low-grade fever (100.4 oF) and lymphopenia (manual count 550/uL), she remained clinically unchanged. Throughout her hospitalization, she maintained a persistent psychotic delusion that she did not have COVID-19, refusing all medical interventions, including a peripheral IV line and supplemental oxygen for the entire duration. Extensive efforts to identify family or a surrogate decision maker were unsuccessful. After consultation with Psychiatry, Bio-Ethics, and hospital leadership, the patient was deemed to lack decision-making capacity regarding treatment or disposition and was placed on a psychiatric hold. However, since any interventions against her will would require sedation, IV access, and potentially increase the risk of nosocomial COVID-19 transmission, she was allowed to remain untreated and was closely monitored for symptoms of worsening respiratory failure.

Discussion

The initial reports of COVID-19 pneumonia focused on ARDS and respiratory failure requiring mechanical ventilation with less emphasis on those with lower severity of illness. This was heightened by health care systems that were overwhelmed with large number of patients while faced with limited supplies and equipment. Given the risk to patients and providers of crash intubations, some recommended early intubation strategies.³ However, the natural history of COVID-19 pneumonia and the threshold for intubation of these patients remain poorly defined despite the creation of prognostic tools.¹⁷ This patient’s persistent hypoxemia and elevated inflammatory markers certainly met markers of disease associated with a high risk of progression.

The greatest concern would have been her level of hypoxemia. Acceptable thresholds of hypoxemia vary, but general consensus would classify pulse oximetry < 90% as hypoxemia and a threshold for administering supplemental oxygen. It is important to recognize how pulse oximetry readings translate to partial pressure of oxygen (PaO₂) measurements (Table 1). Pulse oximetry readings of 90% corresponds to a PaO₂ readings of 60 mm Hg in ideal conditions without the influence of acidosis, PaCO₂, or temperature. While lower readings are of concern, these do not represent absolute indications for assisted ventilatory support as lower levels are well tolerated in a variety of conditions. A common example are patients with chronic obstructive pulmonary disease. Long-term mortality benefits of continuous supplemental oxygen are well established in specific populations, but the threshold for correction in the acute setting remains a case-by-case decision. This decision is complex and is based on more than an absolute number or the amount of oxygen required to achieve a threshold level of oxygenation.

The severity of hypoxemia manifested by this patient may have elicited additional findings of respiratory distress, such as dyspnea and tachypnea. However, in patients with severe COVID-19 pneumonia, dyspnea was not a universal finding, reported in the 20 to 60% range of cohorts, higher in those with ARDS and mechanical ventilation, although some report near universal dyspnea in their series.^1,4,8,22,23 Tachypnea is another symptom of interest. Using a threshold of > 24 breaths/min, tachypnea was noted in 16 to 29% of patients with a much greater proportion (63%) in nonsurvivors.^6,24 Several explanations have been proposed for the discordance between the presence and severity of hypoxemia and lack of symptoms of dyspnea and tachypnea. It is important to recognize that misclassification of the severity of hypoxemia can occur due to technical issues and potential errors involving pulse oximetry measurement and shifts in the oxyhemoglobin dissociation curve. However, this is more pertinent for those with mild disease as the severity of hypoxemia in severe pneumonia is beyond what can be attributed to technical issues.

More important, the ventilatory response curve to hypoxemia may not be normal for some patients, blunted by as much as 50% in older patients, especially in those with diabetes mellitus.^7,25,26 In addition, the ventilatory response varies widely even among normal individuals. This would translate to lower levels of minute ventilation (less tachypnea or respiratory effort) with hypoxemia. Hypocapnic hypoxemia also blunts the ventilatory response to hypoxemia. Subjects do not increase their minute ventilation if the PaCO₂ remains low despite oxygen desaturation to < 70%, especially if PaCO₂ < 30 mm Hg or alternatively, increases in minute ventilation are not seen until the PaCO₂ exceeds 39 mm Hg.²⁷ Both scenarios occur in those with COVID-19 pneumonia and provide another explanation for the absence of respiratory symptoms or signs of respiratory distress in some patients.

The observation of more compliant lungs may help in the understanding of the variable presentation of these patients. Compliant lungs do not require the increased pressure needed to achieve a specific tidal volume that, in turn, may increase the work of breathing. This may add to the explanation of seemingly paradoxical silent hypoxemia in those patients where the combination of a blunted ventilatory response, hypocapnia, shunt physiology, and normal respiratory system compliance is represented by the absence of increased breathing effort despite severe hypoxemia.

If not for the patient’s refusal of medical services, this patient quite possibly would have been intubated due to hypoxemia and health care providers’ concern for her risk of deterioration. Reported intubation and mechanical ventilation rates have varied widely from extremes of from < 5 to 88% in severely ill patients.^9,22 About 75% will need oxygen, but many can be treated and recover without the need for intubation and mechanical ventilation.

As previously mentioned, options for treatment include standard and high-flow oxygen delivery, noninvasive ventilation, and awake prone ventilation. Their role in patient management has been recently outlined, and instead of an early intubation strategy, represents gradual escalation of support that may be sufficient to treat hypoxemia and avoid the need for intubation and mechanical ventilation (Table 2).

Conclusions

Since the emergence of the COVID-19, evidence has accumulated for the benefit of several adjunctive therapies in the treatment of this type of pneumonia, with corticosteroids providing a mortality benefit. Although unknown whether this patient’s experience can be generalized to others or whether it represents her unique response, this case provides another perspective for comparison of treatments and reinforces the need for prospective, randomized clinical trials to establish treatment efficacy. The exact nature of silent hypoxemia of COVID-19 remains incompletely understood; however, this case highlights the importance of treating the individual instead of clinical markers and provides a time course for recovery from pneumonia and severe hypoxemia that occurs without oxygen or any other treatment over about 2 weeks.

In less than a year, COVID-19 has infected nearly 100 million people worldwide and caused more than 2 million deaths and counting. Although the infection fatality rate is estimated to be 1% and the case fatality rate between 2% and 3%, COVID-19 has had a disproportionate effect on the older population and those with comorbidities. Some of these findings are mirrored in the US Department of Veterans Affairs (VA) population, which has seen a higher case fatality rate.^1-4

As a respiratory tract infection, the most dreaded presentation is severe pneumonia with acute hypoxemia, which may rapidly deteriorate to acute respiratory distress syndrome (ARDS) and respiratory failure.^5-7 This possibility has led to early intubation strategies aimed at preempting this rapid deterioration and minimizing viral exposure to health care workers. Intubation rates have varied widely with extremes of 6 to 88%.^8,9

However, this early intubation strategy has waned as some of the rationale behind its endorsement has been called into question. Early intubation bypasses alternatives to intubation; high-flow nasal cannula oxygen, noninvasive ventilation, and awake proning are all effective maneuvers in the appropriate patient.^10,11 The use of first-line high-flow nasal cannula oxygen and noninvasive ventilation has been widely reported. Reports of first-line use of high-flow nasal cannula oxygen has not demonstrated inferior outcomes, nor has the timing of intubation, suggesting a significant portion of patients could benefit from a trial of therapy and eventually avoid intubation.^11-14 Other therapies, such as systemic corticosteroids, confer a mortality benefit in those patients with COVID-19 who require oxygen or mechanical ventilation, but their impact on the progression of respiratory failure and need for intubation are undetermined.

There also are reports of patients who report no signs of respiratory distress or dyspnea with their COVID-19 pneumonia despite profound hypoxemia or high oxygen requirements. Various terms, including silent hypoxemia or happy hypoxia, are descriptive of the demeanor of these patients, and treatment has invariably included oxygen.^15,16 Nevertheless, low oxygen measurements have generally prompted higher levels of supplemental oxygen or more invasive therapies.

Treatment rendered may obscure the trajectory of response, which is important to understand to better position options for invasive therapies and other therapeutics. We recently encountered a patient with a course of illness that represented the natural history of COVID-19 pneumonia with low oxygen levels (referred to as hypoxemia for consistency) that highlighted several issues of management.

Case Presentation

A 62-year-old undomiciled woman with morbid obesity, prediabetes mellitus, long-standing schizophrenia, and bipolar disorder presented to our facility for evaluation of dry cough and need for tuberculosis clearance for admittance to a shelter. She appeared comfortable and was afebrile with blood pressure 111/74 mm Hg, heart rate 82 beats per minute. Her respiratory rate was 18 breaths per minute, but the pulse oximetry showed oxygen saturation of 70 to 75% on room air at rest. A chest X-ray showed bibasilar infiltrates (Figure 1), and a rapid COVID-19 nasopharyngeal polymerase chain reaction (PCR) test returned positive, confirmed by a second PCR test. Baseline inflammatory markers were elevated (Figure 2). In addition, the serum interleukin-6 also was elevated to 66.1 pg/mL (normal < 5.0), erythrocyte sedimentation rate elevated to 69 mm/h, but serum procalcitonin was essentially normal (0.22 ng/mL; normal < 20 ng/mL) as was the serum lactate (1.4 mmol/L).

The patient was admitted to the intensive care unit (ICU) for close monitoring in anticipation of the possibility of decompensation based on her age, hypoxia, and elevated inflammatory markers.¹⁷ Besides a subsequent low-grade fever (100.4 oF) and lymphopenia (manual count 550/uL), she remained clinically unchanged. Throughout her hospitalization, she maintained a persistent psychotic delusion that she did not have COVID-19, refusing all medical interventions, including a peripheral IV line and supplemental oxygen for the entire duration. Extensive efforts to identify family or a surrogate decision maker were unsuccessful. After consultation with Psychiatry, Bio-Ethics, and hospital leadership, the patient was deemed to lack decision-making capacity regarding treatment or disposition and was placed on a psychiatric hold. However, since any interventions against her will would require sedation, IV access, and potentially increase the risk of nosocomial COVID-19 transmission, she was allowed to remain untreated and was closely monitored for symptoms of worsening respiratory failure.

Discussion

The initial reports of COVID-19 pneumonia focused on ARDS and respiratory failure requiring mechanical ventilation with less emphasis on those with lower severity of illness. This was heightened by health care systems that were overwhelmed with large number of patients while faced with limited supplies and equipment. Given the risk to patients and providers of crash intubations, some recommended early intubation strategies.³ However, the natural history of COVID-19 pneumonia and the threshold for intubation of these patients remain poorly defined despite the creation of prognostic tools.¹⁷ This patient’s persistent hypoxemia and elevated inflammatory markers certainly met markers of disease associated with a high risk of progression.

The greatest concern would have been her level of hypoxemia. Acceptable thresholds of hypoxemia vary, but general consensus would classify pulse oximetry < 90% as hypoxemia and a threshold for administering supplemental oxygen. It is important to recognize how pulse oximetry readings translate to partial pressure of oxygen (PaO₂) measurements (Table 1). Pulse oximetry readings of 90% corresponds to a PaO₂ readings of 60 mm Hg in ideal conditions without the influence of acidosis, PaCO₂, or temperature. While lower readings are of concern, these do not represent absolute indications for assisted ventilatory support as lower levels are well tolerated in a variety of conditions. A common example are patients with chronic obstructive pulmonary disease. Long-term mortality benefits of continuous supplemental oxygen are well established in specific populations, but the threshold for correction in the acute setting remains a case-by-case decision. This decision is complex and is based on more than an absolute number or the amount of oxygen required to achieve a threshold level of oxygenation.

The severity of hypoxemia manifested by this patient may have elicited additional findings of respiratory distress, such as dyspnea and tachypnea. However, in patients with severe COVID-19 pneumonia, dyspnea was not a universal finding, reported in the 20 to 60% range of cohorts, higher in those with ARDS and mechanical ventilation, although some report near universal dyspnea in their series.^1,4,8,22,23 Tachypnea is another symptom of interest. Using a threshold of > 24 breaths/min, tachypnea was noted in 16 to 29% of patients with a much greater proportion (63%) in nonsurvivors.^6,24 Several explanations have been proposed for the discordance between the presence and severity of hypoxemia and lack of symptoms of dyspnea and tachypnea. It is important to recognize that misclassification of the severity of hypoxemia can occur due to technical issues and potential errors involving pulse oximetry measurement and shifts in the oxyhemoglobin dissociation curve. However, this is more pertinent for those with mild disease as the severity of hypoxemia in severe pneumonia is beyond what can be attributed to technical issues.

More important, the ventilatory response curve to hypoxemia may not be normal for some patients, blunted by as much as 50% in older patients, especially in those with diabetes mellitus.^7,25,26 In addition, the ventilatory response varies widely even among normal individuals. This would translate to lower levels of minute ventilation (less tachypnea or respiratory effort) with hypoxemia. Hypocapnic hypoxemia also blunts the ventilatory response to hypoxemia. Subjects do not increase their minute ventilation if the PaCO₂ remains low despite oxygen desaturation to < 70%, especially if PaCO₂ < 30 mm Hg or alternatively, increases in minute ventilation are not seen until the PaCO₂ exceeds 39 mm Hg.²⁷ Both scenarios occur in those with COVID-19 pneumonia and provide another explanation for the absence of respiratory symptoms or signs of respiratory distress in some patients.

The observation of more compliant lungs may help in the understanding of the variable presentation of these patients. Compliant lungs do not require the increased pressure needed to achieve a specific tidal volume that, in turn, may increase the work of breathing. This may add to the explanation of seemingly paradoxical silent hypoxemia in those patients where the combination of a blunted ventilatory response, hypocapnia, shunt physiology, and normal respiratory system compliance is represented by the absence of increased breathing effort despite severe hypoxemia.

If not for the patient’s refusal of medical services, this patient quite possibly would have been intubated due to hypoxemia and health care providers’ concern for her risk of deterioration. Reported intubation and mechanical ventilation rates have varied widely from extremes of from < 5 to 88% in severely ill patients.^9,22 About 75% will need oxygen, but many can be treated and recover without the need for intubation and mechanical ventilation.

As previously mentioned, options for treatment include standard and high-flow oxygen delivery, noninvasive ventilation, and awake prone ventilation. Their role in patient management has been recently outlined, and instead of an early intubation strategy, represents gradual escalation of support that may be sufficient to treat hypoxemia and avoid the need for intubation and mechanical ventilation (Table 2).

Conclusions

Since the emergence of the COVID-19, evidence has accumulated for the benefit of several adjunctive therapies in the treatment of this type of pneumonia, with corticosteroids providing a mortality benefit. Although unknown whether this patient’s experience can be generalized to others or whether it represents her unique response, this case provides another perspective for comparison of treatments and reinforces the need for prospective, randomized clinical trials to establish treatment efficacy. The exact nature of silent hypoxemia of COVID-19 remains incompletely understood; however, this case highlights the importance of treating the individual instead of clinical markers and provides a time course for recovery from pneumonia and severe hypoxemia that occurs without oxygen or any other treatment over about 2 weeks.

In a large cohort of insured working adults with severe obesity and nonalcoholic fatty liver disease (NAFLD), the rate of incident cancer was lower during a 10-month median follow-up period among those who underwent bariatric surgery. The rate was especially lower with regard to obesity-related cancers. The risk reduction was greater among patients with cirrhosis.

Among almost 100,000 patients with severe obesity (body mass index >40 kg/m²) and NAFLD, those who underwent bariatric surgery had an 18% and 35% lower risk of developing any cancer or obesity-related cancer, respectively.

Bariatric surgery was associated with a significantly lower risk of being diagnosed with colorectal, pancreatic, endometrial, and thyroid cancer, as well as hepatocellular carcinoma and multiple myeloma (all obesity-related cancers). The findings are from an observational study by Vinod K. Rustgi, MD, MBA, and colleagues, which was published online March 17, 2021, in Gastroenterology.

It was not surprising that bariatric surgery is effective in reducing the malignancy rate among patients with cirrhosis, the researchers wrote, because the surgery results in long-term weight loss, resolution of nonalcoholic steatohepatitis (NASH), and regression of fibrosis.

“Cirrhosis can happen from fatty liver disease or NASH,” Dr. Rustgi, a hepatologist at Robert Wood Johnson Medical School, New Brunswick, N.J., explained to this news organization. “It’s becoming the fastest growing indication for liver transplant, but also the reason for increased rates of hepatocellular carcinoma.”

Current treatment for patients with obesity and fatty liver disease begins with lifestyle changes to lose weight, he continued. “As people lose 10% of their weight, they actually start to see regression of fibrosis in the liver that is correlated with [lower rates of] malignancy outcomes and other deleterious outcomes.” But long-lasting weight loss is extremely difficult to achieve.

Future studies “may identify new targets and treatments, such as antidiabetic-, satiety-, or GLP-1-based medications, for chemoprevention in NAFLD/NASH,” the investigators suggested. However, pharmaceutical agents will likely be very expensive when they eventually get marketed, Dr. Rustgi observed.

Although “bariatric surgery is a more aggressive approach than lifestyle modifications, surgery may provide additional benefits, such as improved quality of life and decreased long-term health care costs,” he and his coauthors concluded.
 

Rising rates of fatty liver disease, obesity

An estimated 30% of the population of the United States has NAFLD, the most common chronic liver disease, the researchers noted in their article. The prevalence of NAFLD increased 2.8-fold in the United States between 2003 and 2011, in parallel with increasing obesity.

NAFLD is more common among male patients with obesity and diabetes and Hispanic patients; “70% of [patients with diabetes] may have fatty liver disease, according to certain surveys,” Dr. Rustgi noted.

Cancer is the second greatest cause of mortality among patients with obesity and NAFLD, he continued, after cardiovascular disease. Cancer mortality is higher than mortality from liver disease.

Obesity-related cancers include adenocarcinoma of the esophagus, cancers of the breast (in postmenopausal women), colon, rectum, endometrium (corpus uterus), gallbladder, gastric cardia, kidney (renal cell), liver, ovary, pancreas, and thyroid, as well as meningioma and multiple myeloma, according to a 2016 report from the International Agency for Research on Cancer working group.

Obesity-related cancer accounted for 40% of all cancer in the United States in 2014 – 55% of cancers in women, and 24% of cancers in men, according to a study published in Morbidity and Mortality Weekly Report in 2017, as previously reported by this news organization.

Several studies, including one presented at Obesity Week in 2019 and later published, have shown that bariatric surgery is linked with a lower risk for cancer in general populations.

One meta-analysis reported that NAFLD is an independent risk factor for cholangiocarcinoma and colorectal, breast, gastric, pancreatic, prostate, and esophageal cancers. In another study, NAFLD was associated with a twofold increased risk for hepatocellular carcinoma and uterine, stomach, pancreatic, and colon cancers, Dr. Rustgi and colleagues noted.

Until now, the impact of bariatric surgery on the risk for cancer among patients with obesity and NAFLD was unknown.
 

Does bariatric surgery curb cancer risk in liver disease?

The researchers examined insurance claims data from the national MarketScan database from Jan. 1, 2007, to Dec. 31, 2017, for patients aged 18-64 years who had health insurance from 350 employers and 100 insurers. They identified 98,090 patients with severe obesity who were newly diagnosed with NAFLD during 2008-2017.

Roughly a third of the cohort (33,435 patients) underwent bariatric surgery. From 2008 to 2017, laparoscopic sleeve gastrectomies increased from 4% of bariatric procedures to 68% of all surgeries. Laparoscopic adjustable gastric band and laparoscopic Roux-en-Y gastric bypass procedures fell from 35% to less than 1% and from 49% to 28%, respectively.

Patients who underwent bariatric surgery were younger (mean age, 44 vs. 46 years), were more likely to be women (74% vs. 62%), and were less likely to have a history of smoking (6% vs. 10%).

During a mean follow-up of 22 months (and a median follow-up of 10 months), there were 911 incident cases of obesity-related cancers. These included cancer of the colon (116 cases), rectum (15), breast (in postmenopausal women; 131), kidney (120), esophagus (16), gastric cardia (8), gallbladder (4), pancreas (44), ovaries (74), endometrium (135), and thyroid (143), as well as hepatocellular carcinoma (49), multiple myeloma (50), and meningioma (6). There were 1,912 incident cases of other cancers, such as brain and lung cancers and leukemia.

A total of 258 patients who underwent bariatric surgery developed an obesity-related cancer (an incidence of 3.83 per 1,000 person-years), compared with 653 patients who did not have bariatric surgery (an incidence of 5.63 per 1,000 person-years).

The researchers noted that study limitations include the fact that it was restricted to privately insured individuals aged 18-64 years with severe obesity. In addition, “the short median follow-up may underestimate the full effect of bariatric surgery on cancer risk,” they wrote.

The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In a large cohort of insured working adults with severe obesity and nonalcoholic fatty liver disease (NAFLD), the rate of incident cancer was lower during a 10-month median follow-up period among those who underwent bariatric surgery. The rate was especially lower with regard to obesity-related cancers. The risk reduction was greater among patients with cirrhosis.

Among almost 100,000 patients with severe obesity (body mass index >40 kg/m²) and NAFLD, those who underwent bariatric surgery had an 18% and 35% lower risk of developing any cancer or obesity-related cancer, respectively.

Bariatric surgery was associated with a significantly lower risk of being diagnosed with colorectal, pancreatic, endometrial, and thyroid cancer, as well as hepatocellular carcinoma and multiple myeloma (all obesity-related cancers). The findings are from an observational study by Vinod K. Rustgi, MD, MBA, and colleagues, which was published online March 17, 2021, in Gastroenterology.

It was not surprising that bariatric surgery is effective in reducing the malignancy rate among patients with cirrhosis, the researchers wrote, because the surgery results in long-term weight loss, resolution of nonalcoholic steatohepatitis (NASH), and regression of fibrosis.

“Cirrhosis can happen from fatty liver disease or NASH,” Dr. Rustgi, a hepatologist at Robert Wood Johnson Medical School, New Brunswick, N.J., explained to this news organization. “It’s becoming the fastest growing indication for liver transplant, but also the reason for increased rates of hepatocellular carcinoma.”

Current treatment for patients with obesity and fatty liver disease begins with lifestyle changes to lose weight, he continued. “As people lose 10% of their weight, they actually start to see regression of fibrosis in the liver that is correlated with [lower rates of] malignancy outcomes and other deleterious outcomes.” But long-lasting weight loss is extremely difficult to achieve.

Future studies “may identify new targets and treatments, such as antidiabetic-, satiety-, or GLP-1-based medications, for chemoprevention in NAFLD/NASH,” the investigators suggested. However, pharmaceutical agents will likely be very expensive when they eventually get marketed, Dr. Rustgi observed.

Although “bariatric surgery is a more aggressive approach than lifestyle modifications, surgery may provide additional benefits, such as improved quality of life and decreased long-term health care costs,” he and his coauthors concluded.
 

Rising rates of fatty liver disease, obesity

An estimated 30% of the population of the United States has NAFLD, the most common chronic liver disease, the researchers noted in their article. The prevalence of NAFLD increased 2.8-fold in the United States between 2003 and 2011, in parallel with increasing obesity.

NAFLD is more common among male patients with obesity and diabetes and Hispanic patients; “70% of [patients with diabetes] may have fatty liver disease, according to certain surveys,” Dr. Rustgi noted.

Cancer is the second greatest cause of mortality among patients with obesity and NAFLD, he continued, after cardiovascular disease. Cancer mortality is higher than mortality from liver disease.

Obesity-related cancers include adenocarcinoma of the esophagus, cancers of the breast (in postmenopausal women), colon, rectum, endometrium (corpus uterus), gallbladder, gastric cardia, kidney (renal cell), liver, ovary, pancreas, and thyroid, as well as meningioma and multiple myeloma, according to a 2016 report from the International Agency for Research on Cancer working group.

Obesity-related cancer accounted for 40% of all cancer in the United States in 2014 – 55% of cancers in women, and 24% of cancers in men, according to a study published in Morbidity and Mortality Weekly Report in 2017, as previously reported by this news organization.

Several studies, including one presented at Obesity Week in 2019 and later published, have shown that bariatric surgery is linked with a lower risk for cancer in general populations.

One meta-analysis reported that NAFLD is an independent risk factor for cholangiocarcinoma and colorectal, breast, gastric, pancreatic, prostate, and esophageal cancers. In another study, NAFLD was associated with a twofold increased risk for hepatocellular carcinoma and uterine, stomach, pancreatic, and colon cancers, Dr. Rustgi and colleagues noted.

Until now, the impact of bariatric surgery on the risk for cancer among patients with obesity and NAFLD was unknown.
 

Does bariatric surgery curb cancer risk in liver disease?

The researchers examined insurance claims data from the national MarketScan database from Jan. 1, 2007, to Dec. 31, 2017, for patients aged 18-64 years who had health insurance from 350 employers and 100 insurers. They identified 98,090 patients with severe obesity who were newly diagnosed with NAFLD during 2008-2017.

Roughly a third of the cohort (33,435 patients) underwent bariatric surgery. From 2008 to 2017, laparoscopic sleeve gastrectomies increased from 4% of bariatric procedures to 68% of all surgeries. Laparoscopic adjustable gastric band and laparoscopic Roux-en-Y gastric bypass procedures fell from 35% to less than 1% and from 49% to 28%, respectively.

Patients who underwent bariatric surgery were younger (mean age, 44 vs. 46 years), were more likely to be women (74% vs. 62%), and were less likely to have a history of smoking (6% vs. 10%).

During a mean follow-up of 22 months (and a median follow-up of 10 months), there were 911 incident cases of obesity-related cancers. These included cancer of the colon (116 cases), rectum (15), breast (in postmenopausal women; 131), kidney (120), esophagus (16), gastric cardia (8), gallbladder (4), pancreas (44), ovaries (74), endometrium (135), and thyroid (143), as well as hepatocellular carcinoma (49), multiple myeloma (50), and meningioma (6). There were 1,912 incident cases of other cancers, such as brain and lung cancers and leukemia.

A total of 258 patients who underwent bariatric surgery developed an obesity-related cancer (an incidence of 3.83 per 1,000 person-years), compared with 653 patients who did not have bariatric surgery (an incidence of 5.63 per 1,000 person-years).

The researchers noted that study limitations include the fact that it was restricted to privately insured individuals aged 18-64 years with severe obesity. In addition, “the short median follow-up may underestimate the full effect of bariatric surgery on cancer risk,” they wrote.

The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In a large cohort of insured working adults with severe obesity and nonalcoholic fatty liver disease (NAFLD), the rate of incident cancer was lower during a 10-month median follow-up period among those who underwent bariatric surgery. The rate was especially lower with regard to obesity-related cancers. The risk reduction was greater among patients with cirrhosis.

Among almost 100,000 patients with severe obesity (body mass index >40 kg/m²) and NAFLD, those who underwent bariatric surgery had an 18% and 35% lower risk of developing any cancer or obesity-related cancer, respectively.

Bariatric surgery was associated with a significantly lower risk of being diagnosed with colorectal, pancreatic, endometrial, and thyroid cancer, as well as hepatocellular carcinoma and multiple myeloma (all obesity-related cancers). The findings are from an observational study by Vinod K. Rustgi, MD, MBA, and colleagues, which was published online March 17, 2021, in Gastroenterology.

It was not surprising that bariatric surgery is effective in reducing the malignancy rate among patients with cirrhosis, the researchers wrote, because the surgery results in long-term weight loss, resolution of nonalcoholic steatohepatitis (NASH), and regression of fibrosis.

“Cirrhosis can happen from fatty liver disease or NASH,” Dr. Rustgi, a hepatologist at Robert Wood Johnson Medical School, New Brunswick, N.J., explained to this news organization. “It’s becoming the fastest growing indication for liver transplant, but also the reason for increased rates of hepatocellular carcinoma.”

Current treatment for patients with obesity and fatty liver disease begins with lifestyle changes to lose weight, he continued. “As people lose 10% of their weight, they actually start to see regression of fibrosis in the liver that is correlated with [lower rates of] malignancy outcomes and other deleterious outcomes.” But long-lasting weight loss is extremely difficult to achieve.

Future studies “may identify new targets and treatments, such as antidiabetic-, satiety-, or GLP-1-based medications, for chemoprevention in NAFLD/NASH,” the investigators suggested. However, pharmaceutical agents will likely be very expensive when they eventually get marketed, Dr. Rustgi observed.

Although “bariatric surgery is a more aggressive approach than lifestyle modifications, surgery may provide additional benefits, such as improved quality of life and decreased long-term health care costs,” he and his coauthors concluded.
 

Rising rates of fatty liver disease, obesity

An estimated 30% of the population of the United States has NAFLD, the most common chronic liver disease, the researchers noted in their article. The prevalence of NAFLD increased 2.8-fold in the United States between 2003 and 2011, in parallel with increasing obesity.

NAFLD is more common among male patients with obesity and diabetes and Hispanic patients; “70% of [patients with diabetes] may have fatty liver disease, according to certain surveys,” Dr. Rustgi noted.

Cancer is the second greatest cause of mortality among patients with obesity and NAFLD, he continued, after cardiovascular disease. Cancer mortality is higher than mortality from liver disease.

Obesity-related cancers include adenocarcinoma of the esophagus, cancers of the breast (in postmenopausal women), colon, rectum, endometrium (corpus uterus), gallbladder, gastric cardia, kidney (renal cell), liver, ovary, pancreas, and thyroid, as well as meningioma and multiple myeloma, according to a 2016 report from the International Agency for Research on Cancer working group.

Obesity-related cancer accounted for 40% of all cancer in the United States in 2014 – 55% of cancers in women, and 24% of cancers in men, according to a study published in Morbidity and Mortality Weekly Report in 2017, as previously reported by this news organization.

Several studies, including one presented at Obesity Week in 2019 and later published, have shown that bariatric surgery is linked with a lower risk for cancer in general populations.

One meta-analysis reported that NAFLD is an independent risk factor for cholangiocarcinoma and colorectal, breast, gastric, pancreatic, prostate, and esophageal cancers. In another study, NAFLD was associated with a twofold increased risk for hepatocellular carcinoma and uterine, stomach, pancreatic, and colon cancers, Dr. Rustgi and colleagues noted.

Until now, the impact of bariatric surgery on the risk for cancer among patients with obesity and NAFLD was unknown.
 

Does bariatric surgery curb cancer risk in liver disease?

The researchers examined insurance claims data from the national MarketScan database from Jan. 1, 2007, to Dec. 31, 2017, for patients aged 18-64 years who had health insurance from 350 employers and 100 insurers. They identified 98,090 patients with severe obesity who were newly diagnosed with NAFLD during 2008-2017.

Roughly a third of the cohort (33,435 patients) underwent bariatric surgery. From 2008 to 2017, laparoscopic sleeve gastrectomies increased from 4% of bariatric procedures to 68% of all surgeries. Laparoscopic adjustable gastric band and laparoscopic Roux-en-Y gastric bypass procedures fell from 35% to less than 1% and from 49% to 28%, respectively.

Patients who underwent bariatric surgery were younger (mean age, 44 vs. 46 years), were more likely to be women (74% vs. 62%), and were less likely to have a history of smoking (6% vs. 10%).

During a mean follow-up of 22 months (and a median follow-up of 10 months), there were 911 incident cases of obesity-related cancers. These included cancer of the colon (116 cases), rectum (15), breast (in postmenopausal women; 131), kidney (120), esophagus (16), gastric cardia (8), gallbladder (4), pancreas (44), ovaries (74), endometrium (135), and thyroid (143), as well as hepatocellular carcinoma (49), multiple myeloma (50), and meningioma (6). There were 1,912 incident cases of other cancers, such as brain and lung cancers and leukemia.

A total of 258 patients who underwent bariatric surgery developed an obesity-related cancer (an incidence of 3.83 per 1,000 person-years), compared with 653 patients who did not have bariatric surgery (an incidence of 5.63 per 1,000 person-years).

The researchers noted that study limitations include the fact that it was restricted to privately insured individuals aged 18-64 years with severe obesity. In addition, “the short median follow-up may underestimate the full effect of bariatric surgery on cancer risk,” they wrote.

The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Over the past decade, natural disasters and health care emergencies have increased 74%, averaging 400 documented events per year.¹ These unpredictable and sometimes devastating events negatively impact the physical and mental health of communities, taxing already stretched health care system resources and the economy.^2,3 During many of these events, patients inappropriately use hospitals, emergency departments (EDs), and critical care resources for chronic disease and elective health care management, resulting in medication shortages, health care access concerns, and treatment delays.⁴

Most available emergency preparedness programs rely solely on volunteers and/or public health providers to address the resultant coverage gap; however, instability in state and federal funding can make it difficult to maintain and sustain focused preparedness and response efforts. Alaska’s vast geography, low population density (1.2 people per square mile), and access limitations (about 200 villages only reachable by air or boat) make it especially challenging to provide reliable and sustained emergency preparedness and response support. Therefore, all eligible health care providers (HCPs) in Alaska must be involved in preparedness and response efforts.

Despite being the most accessible HCPs, pharmacists and student pharmacists, have not been actively involved in statewide emergency preparedness planning and disaster management efforts in Alaska. In preparation for and during disasters, for example, pharmacists may administer vaccinations, conduct point of care testing, dispense emergency medications, provide emergency medication refills, help mitigate medication shortages, and provide reliable health information to other health care professionals, patients, and their families as they prepare for and manage care during the event.⁴

The goal of this paper is to share the experience at the University of Alaska Anchorage/Idaho State University College of Pharmacy (UAA/ISU) in the development and implementation of a sustainable emergency preparedness and response support network (EPRSN) model; leveraging an established university student leadership structure and Doctor of Pharmacy (PharmD) students to support sharing of information among community pharmacies, state emergency response teams, and community members. 

2018 Alaska Earthquake

On November 30, 2018, southcentral Alaska experienced a magnitude 7.1 earthquake, affecting nearly 295,000 people (approximately 40% of Alaska’s population) damaging roads, buildings, homes, and health care facilities. Emergency response efforts were quickly overwhelmed and hospital EDs became overburdened with patients seeking not only emergent, but also chronic care along with requests for prescription refills.

During disasters, disruptions in medication access and adherence are common. Disruptions can lead to disease exacerbation or progression, hospitalization, and/or death; all of which further contribute to the health care system and economic health burden. For example, after Hurricane Katrina, 46% of patients on hypertension medications had less than perfect adherence due to a variety of reasons (eg, not bringing any or enough medications during evacuation, lack of access to refills).⁵ Nonadherence to prescription hypertension medication specifically can lead to stroke, heart attack, and more rapidly progressing kidney dysfunction. Patients with diabetes mellitus (DM) also experience negative consequences due to disruptions in medication adherence.⁶ Lack of access to medications and supplies for DM can likewise lead to significant health sequelae, including acute hyperglycemic events, which can be life-threatening; ongoing hyperglycemia can lead to higher rates of cardiovascular disease, kidney disease, nerve damage, and diabetic retinopathy.⁷ However, the long-term effects of a natural disaster on health in terms of morbidity and mortality often go unreported, and their impact on chronic health conditions may be underestimated and last for years after the event.

As future health care professionals, student pharmacists continually seek opportunities to engage with and support communities; including preparing for, responding to, mitigating against, and recovering from disasters that affect the health care system and access to needed drug therapies. After the earthquake, student pharmacists reached out to state and local emergency response programs detailed within The State of Alaska Emergency Operations Plan to find opportunities to volunteer.

Agencies contacted included the Office of Emergency Management (OEM) for the Municipality of Anchorage. OEM partners with local health, fire, and police departments, the Alaska Department of Health and Social Services and Emergency Management, the Federal Emergency Management Agency, Centers for Disease Control and Prevention, American Red Cross, and the Salvation Army. It is important to note, due to lack of funding, Alaska no longer has a Medical Reserve Corps, which significantly impacts community emergency response and resilience efforts. After the earthquake, the emergency program manager extended an invitation to student pharmacists to join the joint medical emergency conference call, where local HCPs discuss emergency protocols, identify gaps, and work together to identify solutions.

During this call there was a consensus among HCPs that many patients were inappropriately seeking to fill and refill prescription medications in the ED, and staff were ill-prepared to guide patients to the appropriate services, unaware of which pharmacies were impacted by the earthquake; therefore unable to direct patients to still-operational pharmacies in the area. Together faculty and students discussed how student pharmacists could be involved in filling these identified information gaps and enhance communication among HCPs and entities. It was determined that if student pharmacists established and maintained open lines of communication with community pharmacists, they could efficiently determine which pharmacies were open and operational after disasters and disseminate that information to EDs and health care facilities in order to better direct patients to appropriate health care services.

Observations 

A question/answer format and time line approach was used to review the steps leading to EPRSN program development and establishment of project/model deliverables.

Identified gaps

Chronic disease management. According to interviews conducted by the National Center for Disaster Preparedness, people often inappropriately use EDs during disasters.⁸ EDs do not stock enough medications to refill prescriptions for patients outside of their emergent care needs and are typically ill-suited for patients’ chronic disease management. At the time of the earthquake in Alaska no specific place/organization had been established to collect, store, or disseminate information regarding available pharmacy resources in an emergency. Had such a system been in place to actively inform HCPs and community members which pharmacies were open and operational, it is likely that many negative consequences related to health care utilization could have been reduced or avoided, including the number of people inappropriately using EDs for chronic prescription medication refills. This would not only reduce the burden on the health care system but allow for patients with both emergency and chronic needs to be seen quickly and prevent unnecessary health care costs.

Pharmacists play a vital role in managing chronic diseases.⁹ Due to extensive education and training, they are considered medication experts, ideally suited to manage chronic medication therapy, help prevent or minimize disease exacerbation and/or progression, reduce preventable health care costs, improve patient quality of life, and reduce morbidity and mortality.⁹ Pharmacists are accessible and strategically located throughout communities and provide patients with continuity of care other HCPs may be unable to provide. For example, during the COVID-19 pandemic, pharmacies remained open when other primary care providers (PCPs) were not. In addition, during times of natural disasters pharmacies tend to remain open unless there are extenuating circumstances (eg, unsafe building infrastructure, unsafe drug supply).

Emergency Response. To determine the role pharmacists play in emergency preparedness efforts we looked initially to the peer-reviewed literature (search terms: emergency preparedness, natural disasters, pharmacy/pharmacies) then turned to materials and research produced by organizations outside of the traditional commercial and academic publishing channels; however, most emergency preparedness protocols and standard operating procedures (SOPs) did not pertain to pharmacies or acknowledge the contribution of pharmacists. Researchers urge both state and federal governments to foster relationships with and use community pharmacist’s expertise and expanded roles in order to improve the nation’s public health.¹⁰

Historically, pharmacists within the US Public Health Service (PHS) have responded alongside local HCPs to meet the needs of communities during public health emergencies. Pharmacists were pivotal in the 2009 response to H1N1 influenza and the 2015 Ebola response, both abroad and within the United States.⁶ Pharmacists screened and triaged patients, provided life-saving vaccinations, and supported community and health care system education initiatives. However, as the COVID-19 pandemic has demonstrated, responding to a public health crisis takes more than the 1,000 pharmacists serving in the PHS.¹¹ The American Society of Health-System Pharmacists argues that all pharmacists should be involved in working with public health planners.¹²

Community and health-systems pharmacists are vital to current and future public health responses and represent a largely untapped resource. Pharmacists across the country, especially in rural and underserved communities, have the potential to significantly impact emergency preparedness and response efforts. The > 319,000 US pharmacists comprise a sizable portion of the population and can play vital roles during emergency situations or disasters.¹³ Often after catastrophic events, community pharmacists provide first-aid, emergency refills, medication counseling, point of care testing, triage patients and serve on emergency response teams.¹⁴ However, pharmacists alone cannot address all medication-related patient needs and student pharmacists likewise have a role in emergency preparedness and response efforts. By participating in these efforts and learning these roles as students, they are better prepared to engage in emergency efforts as pharmacists.

Student pharmacist support. There are more than 140 accredited pharmacy schools across the United States, employing > 6,500 pharmacy faculty, and teaching > 63,000 student pharmacists.¹⁵ The majority of schools provide free and volunteer-based health care services and collaborate with local, regional, and national entities such as state boards of pharmacy, professional pharmacy organizations, and the American Pharmacist Association (APhA). Through the APhA Academy of Student Pharmacists (ASP), in 2018 and 2019 Operation Heart Campaign, 4,239 patients were referred to a PCP for follow-up care, 117,251 patients received health and wellness services, and 2,772,179 patients were educated regarding cardiovascular disease, the most common noncommunicable disease in the United States.^16,17 Also, in 2018 and 2019, APhA-ASPs Operation Diabetes Campaign referred 3,785 patients to their PCP, provided health and wellness services to 36,334 patients, and educated 1,114,281 patients regarding DM.¹⁸

Student pharmacists are positioned across the country with reach to rural and underserved communities and have student organizational structures in place to manage student volunteers and support health care service opportunities. These structures could readily be used to augment and provide emergency pharmacy services and the coordination of chronic care services during times of emergency or disaster. Student leaders are well situated to coordinate communication and cooperation across health care disciplines and to facilitate local community pharmacy resource information collection and distribution.

Emergency Preparation Program

To address gaps in emergency preparedness and response, student pharmacists at UAA/ISU took the following steps to develop the EPRSN. Planning involved a multistep process. Step 1 identified important uncaptured data (eg, operational status, staffing, hours of operation, continuity and safety of drug supply chain, building/parking lot damage) required to direct patients to the appropriate medication-related care during an emergency. For step 2, student pharmacists obtained a list of the 138 pharmacies in Alaska from the state board of pharmacy. Pharmacies were contacted by student pharmacists using an established telephone script and updated contact information collected was stored on a secure, online drive accessible to UAA/ISU College of Pharmacy faculty and students using their UAA/ISU email address. In step 3, the APhA-ASP president elect and 3 leaders in each of the 16 APhA-ASP operation in charge of the EPRSN Alaska initiative, surveyed student leaders to determine student willingness to participate. Step 4 was to develop an organizational structure using established leadership structure to collect, capture, update, and share pharmacy data with state emergency response teams. Sustainability from year to year will be ensured through incorporation into the APhA-ASP student engagement framework (eg, annual training led by the president elect, contact information updated biyearly by student leaders, and oversight provided by College of Pharmacy faculty). Step 5 was to create SOPs, flowcharts, telephone scripts, talking points, and student training materials. And in the final preparatory step, plan documents and deliverables were provided to faculty administration and advisors within the College of Pharmacy for initial approval and presented to the student leadership for final approval.

EPRSN will be activated in the case of a natural disaster or state of emergency. Pharmacy students will contact all pharmacies within the designated area to collect up-to-date vital information (eg, operational status, staffing, hours of operation, safe drug supply, building/parking lot damage). Collected information will be disseminated to appropriate community members, HCPs, health care facilities, and emergency preparedness officials, under the direction of the Emergency Program Manager. 

Discussion

In order to make informed and timely decisions during emergency situations, patients, HCPs, and health care systems must have appropriate situational awareness. The ability of decision makers to respond is directly dependent on timeliness and relevance of the information collected and shared and greatly contributes to this awareness. Accurate, effective, and consistent information collection has historically been one of the greatest challenges to situational awareness. This is particularly important in times of disaster when necessary emergency situation data may not exist, tools to collect data are inefficient and/or ineffective, and/or current data are inaccessible to relevant parties.¹⁹ This was the case in the Alaska earthquake of 2018 and more recently the COVID-19 pandemic of 2020 where information sharing deficits and structural barriers became even more evident.  

Transfer of knowledge and information is especially critical during an emergency situation. Ineffective communication and information sharing results in transfer gaps. Gaps that result from inadequate transfers of care between HCPs are referred to as hand-off gaps. Training gaps result from inadequate preparation on the part of HCPs and civic leaders as well as in public health policies and procedures and in understanding of needs in emergent situations. Organization gaps occur when an individual changes positions or leaves a given institution and the acquired knowledge is not shared with others before departure or the replacement individual does not receive necessary training. 

In both the Alaska earthquake and the COVID-19 pandemic, gaps in hand-offs, training, and organization were identified. Pharmacists were involved in the solution, providing care, addressing unmet health needs, and supporting the health care system. Many patients and HCPs remain unaware of the services pharmacists are capable and willing to provide, but at even a more basic level they are unsure of what services may be needed in emergency situations. Pharmacists are often used and considered vital HCPs after natural disasters or emergency situations, providing services that extend beyond their normal duties, yet remain within their SOP and expertise and address the medication management needs of their patients, ensuring safe, effective, and continuous access to needed pharmaceuticals.

It is vital that pharmacists and student pharmacists take an active role in emergency preparedness, that students get involved early in outreach and engagement initiatives for which they are ideally suited to coordinate in their communities, and that College of Pharmacy faculty support student pharmacist efforts to continue to highlight the professional roles of pharmacists, in routine health care as well as during times of crisis or disaster. It is important to note that an indirect but important cause of patient mortality related to an emergency event is the inability to access routine health care. If pharmacists and student pharmacists were more involved in emergency preparedness and response efforts, they could play an even greater role in providing much needed health care to patients during times when the health care system is overtaxed (facilitating medication refills and providing administrative and health care support).

Conclusions

Emergency and disaster preparedness are vital to promote the appropriate use of health care resources and prevent health-related complications. Student pharmacists represent a sustainable resource, uniquely positioned to identify community needs, support emergency efforts, coordinate with local pharmacies, and work with pharmacists and others to ensure patients receive the care they need. This work has the potential to improve utilization of health care resources and service delivery during natural disasters and emergencies, on a local, state, and regional level, with the overall goal of maintaining patient health and well-being.

Over the past decade, natural disasters and health care emergencies have increased 74%, averaging 400 documented events per year.¹ These unpredictable and sometimes devastating events negatively impact the physical and mental health of communities, taxing already stretched health care system resources and the economy.^2,3 During many of these events, patients inappropriately use hospitals, emergency departments (EDs), and critical care resources for chronic disease and elective health care management, resulting in medication shortages, health care access concerns, and treatment delays.⁴

Most available emergency preparedness programs rely solely on volunteers and/or public health providers to address the resultant coverage gap; however, instability in state and federal funding can make it difficult to maintain and sustain focused preparedness and response efforts. Alaska’s vast geography, low population density (1.2 people per square mile), and access limitations (about 200 villages only reachable by air or boat) make it especially challenging to provide reliable and sustained emergency preparedness and response support. Therefore, all eligible health care providers (HCPs) in Alaska must be involved in preparedness and response efforts.

Despite being the most accessible HCPs, pharmacists and student pharmacists, have not been actively involved in statewide emergency preparedness planning and disaster management efforts in Alaska. In preparation for and during disasters, for example, pharmacists may administer vaccinations, conduct point of care testing, dispense emergency medications, provide emergency medication refills, help mitigate medication shortages, and provide reliable health information to other health care professionals, patients, and their families as they prepare for and manage care during the event.⁴

The goal of this paper is to share the experience at the University of Alaska Anchorage/Idaho State University College of Pharmacy (UAA/ISU) in the development and implementation of a sustainable emergency preparedness and response support network (EPRSN) model; leveraging an established university student leadership structure and Doctor of Pharmacy (PharmD) students to support sharing of information among community pharmacies, state emergency response teams, and community members. 

2018 Alaska Earthquake

On November 30, 2018, southcentral Alaska experienced a magnitude 7.1 earthquake, affecting nearly 295,000 people (approximately 40% of Alaska’s population) damaging roads, buildings, homes, and health care facilities. Emergency response efforts were quickly overwhelmed and hospital EDs became overburdened with patients seeking not only emergent, but also chronic care along with requests for prescription refills.

During disasters, disruptions in medication access and adherence are common. Disruptions can lead to disease exacerbation or progression, hospitalization, and/or death; all of which further contribute to the health care system and economic health burden. For example, after Hurricane Katrina, 46% of patients on hypertension medications had less than perfect adherence due to a variety of reasons (eg, not bringing any or enough medications during evacuation, lack of access to refills).⁵ Nonadherence to prescription hypertension medication specifically can lead to stroke, heart attack, and more rapidly progressing kidney dysfunction. Patients with diabetes mellitus (DM) also experience negative consequences due to disruptions in medication adherence.⁶ Lack of access to medications and supplies for DM can likewise lead to significant health sequelae, including acute hyperglycemic events, which can be life-threatening; ongoing hyperglycemia can lead to higher rates of cardiovascular disease, kidney disease, nerve damage, and diabetic retinopathy.⁷ However, the long-term effects of a natural disaster on health in terms of morbidity and mortality often go unreported, and their impact on chronic health conditions may be underestimated and last for years after the event.

As future health care professionals, student pharmacists continually seek opportunities to engage with and support communities; including preparing for, responding to, mitigating against, and recovering from disasters that affect the health care system and access to needed drug therapies. After the earthquake, student pharmacists reached out to state and local emergency response programs detailed within The State of Alaska Emergency Operations Plan to find opportunities to volunteer.

Agencies contacted included the Office of Emergency Management (OEM) for the Municipality of Anchorage. OEM partners with local health, fire, and police departments, the Alaska Department of Health and Social Services and Emergency Management, the Federal Emergency Management Agency, Centers for Disease Control and Prevention, American Red Cross, and the Salvation Army. It is important to note, due to lack of funding, Alaska no longer has a Medical Reserve Corps, which significantly impacts community emergency response and resilience efforts. After the earthquake, the emergency program manager extended an invitation to student pharmacists to join the joint medical emergency conference call, where local HCPs discuss emergency protocols, identify gaps, and work together to identify solutions.

During this call there was a consensus among HCPs that many patients were inappropriately seeking to fill and refill prescription medications in the ED, and staff were ill-prepared to guide patients to the appropriate services, unaware of which pharmacies were impacted by the earthquake; therefore unable to direct patients to still-operational pharmacies in the area. Together faculty and students discussed how student pharmacists could be involved in filling these identified information gaps and enhance communication among HCPs and entities. It was determined that if student pharmacists established and maintained open lines of communication with community pharmacists, they could efficiently determine which pharmacies were open and operational after disasters and disseminate that information to EDs and health care facilities in order to better direct patients to appropriate health care services.

Observations 

A question/answer format and time line approach was used to review the steps leading to EPRSN program development and establishment of project/model deliverables.

Identified gaps

Chronic disease management. According to interviews conducted by the National Center for Disaster Preparedness, people often inappropriately use EDs during disasters.⁸ EDs do not stock enough medications to refill prescriptions for patients outside of their emergent care needs and are typically ill-suited for patients’ chronic disease management. At the time of the earthquake in Alaska no specific place/organization had been established to collect, store, or disseminate information regarding available pharmacy resources in an emergency. Had such a system been in place to actively inform HCPs and community members which pharmacies were open and operational, it is likely that many negative consequences related to health care utilization could have been reduced or avoided, including the number of people inappropriately using EDs for chronic prescription medication refills. This would not only reduce the burden on the health care system but allow for patients with both emergency and chronic needs to be seen quickly and prevent unnecessary health care costs.

Pharmacists play a vital role in managing chronic diseases.⁹ Due to extensive education and training, they are considered medication experts, ideally suited to manage chronic medication therapy, help prevent or minimize disease exacerbation and/or progression, reduce preventable health care costs, improve patient quality of life, and reduce morbidity and mortality.⁹ Pharmacists are accessible and strategically located throughout communities and provide patients with continuity of care other HCPs may be unable to provide. For example, during the COVID-19 pandemic, pharmacies remained open when other primary care providers (PCPs) were not. In addition, during times of natural disasters pharmacies tend to remain open unless there are extenuating circumstances (eg, unsafe building infrastructure, unsafe drug supply).

Emergency Response. To determine the role pharmacists play in emergency preparedness efforts we looked initially to the peer-reviewed literature (search terms: emergency preparedness, natural disasters, pharmacy/pharmacies) then turned to materials and research produced by organizations outside of the traditional commercial and academic publishing channels; however, most emergency preparedness protocols and standard operating procedures (SOPs) did not pertain to pharmacies or acknowledge the contribution of pharmacists. Researchers urge both state and federal governments to foster relationships with and use community pharmacist’s expertise and expanded roles in order to improve the nation’s public health.¹⁰

Historically, pharmacists within the US Public Health Service (PHS) have responded alongside local HCPs to meet the needs of communities during public health emergencies. Pharmacists were pivotal in the 2009 response to H1N1 influenza and the 2015 Ebola response, both abroad and within the United States.⁶ Pharmacists screened and triaged patients, provided life-saving vaccinations, and supported community and health care system education initiatives. However, as the COVID-19 pandemic has demonstrated, responding to a public health crisis takes more than the 1,000 pharmacists serving in the PHS.¹¹ The American Society of Health-System Pharmacists argues that all pharmacists should be involved in working with public health planners.¹²

Community and health-systems pharmacists are vital to current and future public health responses and represent a largely untapped resource. Pharmacists across the country, especially in rural and underserved communities, have the potential to significantly impact emergency preparedness and response efforts. The > 319,000 US pharmacists comprise a sizable portion of the population and can play vital roles during emergency situations or disasters.¹³ Often after catastrophic events, community pharmacists provide first-aid, emergency refills, medication counseling, point of care testing, triage patients and serve on emergency response teams.¹⁴ However, pharmacists alone cannot address all medication-related patient needs and student pharmacists likewise have a role in emergency preparedness and response efforts. By participating in these efforts and learning these roles as students, they are better prepared to engage in emergency efforts as pharmacists.

Student pharmacist support. There are more than 140 accredited pharmacy schools across the United States, employing > 6,500 pharmacy faculty, and teaching > 63,000 student pharmacists.¹⁵ The majority of schools provide free and volunteer-based health care services and collaborate with local, regional, and national entities such as state boards of pharmacy, professional pharmacy organizations, and the American Pharmacist Association (APhA). Through the APhA Academy of Student Pharmacists (ASP), in 2018 and 2019 Operation Heart Campaign, 4,239 patients were referred to a PCP for follow-up care, 117,251 patients received health and wellness services, and 2,772,179 patients were educated regarding cardiovascular disease, the most common noncommunicable disease in the United States.^16,17 Also, in 2018 and 2019, APhA-ASPs Operation Diabetes Campaign referred 3,785 patients to their PCP, provided health and wellness services to 36,334 patients, and educated 1,114,281 patients regarding DM.¹⁸

Student pharmacists are positioned across the country with reach to rural and underserved communities and have student organizational structures in place to manage student volunteers and support health care service opportunities. These structures could readily be used to augment and provide emergency pharmacy services and the coordination of chronic care services during times of emergency or disaster. Student leaders are well situated to coordinate communication and cooperation across health care disciplines and to facilitate local community pharmacy resource information collection and distribution.

Emergency Preparation Program

To address gaps in emergency preparedness and response, student pharmacists at UAA/ISU took the following steps to develop the EPRSN. Planning involved a multistep process. Step 1 identified important uncaptured data (eg, operational status, staffing, hours of operation, continuity and safety of drug supply chain, building/parking lot damage) required to direct patients to the appropriate medication-related care during an emergency. For step 2, student pharmacists obtained a list of the 138 pharmacies in Alaska from the state board of pharmacy. Pharmacies were contacted by student pharmacists using an established telephone script and updated contact information collected was stored on a secure, online drive accessible to UAA/ISU College of Pharmacy faculty and students using their UAA/ISU email address. In step 3, the APhA-ASP president elect and 3 leaders in each of the 16 APhA-ASP operation in charge of the EPRSN Alaska initiative, surveyed student leaders to determine student willingness to participate. Step 4 was to develop an organizational structure using established leadership structure to collect, capture, update, and share pharmacy data with state emergency response teams. Sustainability from year to year will be ensured through incorporation into the APhA-ASP student engagement framework (eg, annual training led by the president elect, contact information updated biyearly by student leaders, and oversight provided by College of Pharmacy faculty). Step 5 was to create SOPs, flowcharts, telephone scripts, talking points, and student training materials. And in the final preparatory step, plan documents and deliverables were provided to faculty administration and advisors within the College of Pharmacy for initial approval and presented to the student leadership for final approval.

EPRSN will be activated in the case of a natural disaster or state of emergency. Pharmacy students will contact all pharmacies within the designated area to collect up-to-date vital information (eg, operational status, staffing, hours of operation, safe drug supply, building/parking lot damage). Collected information will be disseminated to appropriate community members, HCPs, health care facilities, and emergency preparedness officials, under the direction of the Emergency Program Manager. 

Discussion

In order to make informed and timely decisions during emergency situations, patients, HCPs, and health care systems must have appropriate situational awareness. The ability of decision makers to respond is directly dependent on timeliness and relevance of the information collected and shared and greatly contributes to this awareness. Accurate, effective, and consistent information collection has historically been one of the greatest challenges to situational awareness. This is particularly important in times of disaster when necessary emergency situation data may not exist, tools to collect data are inefficient and/or ineffective, and/or current data are inaccessible to relevant parties.¹⁹ This was the case in the Alaska earthquake of 2018 and more recently the COVID-19 pandemic of 2020 where information sharing deficits and structural barriers became even more evident.  

Transfer of knowledge and information is especially critical during an emergency situation. Ineffective communication and information sharing results in transfer gaps. Gaps that result from inadequate transfers of care between HCPs are referred to as hand-off gaps. Training gaps result from inadequate preparation on the part of HCPs and civic leaders as well as in public health policies and procedures and in understanding of needs in emergent situations. Organization gaps occur when an individual changes positions or leaves a given institution and the acquired knowledge is not shared with others before departure or the replacement individual does not receive necessary training. 

In both the Alaska earthquake and the COVID-19 pandemic, gaps in hand-offs, training, and organization were identified. Pharmacists were involved in the solution, providing care, addressing unmet health needs, and supporting the health care system. Many patients and HCPs remain unaware of the services pharmacists are capable and willing to provide, but at even a more basic level they are unsure of what services may be needed in emergency situations. Pharmacists are often used and considered vital HCPs after natural disasters or emergency situations, providing services that extend beyond their normal duties, yet remain within their SOP and expertise and address the medication management needs of their patients, ensuring safe, effective, and continuous access to needed pharmaceuticals.

It is vital that pharmacists and student pharmacists take an active role in emergency preparedness, that students get involved early in outreach and engagement initiatives for which they are ideally suited to coordinate in their communities, and that College of Pharmacy faculty support student pharmacist efforts to continue to highlight the professional roles of pharmacists, in routine health care as well as during times of crisis or disaster. It is important to note that an indirect but important cause of patient mortality related to an emergency event is the inability to access routine health care. If pharmacists and student pharmacists were more involved in emergency preparedness and response efforts, they could play an even greater role in providing much needed health care to patients during times when the health care system is overtaxed (facilitating medication refills and providing administrative and health care support).

Conclusions

Emergency and disaster preparedness are vital to promote the appropriate use of health care resources and prevent health-related complications. Student pharmacists represent a sustainable resource, uniquely positioned to identify community needs, support emergency efforts, coordinate with local pharmacies, and work with pharmacists and others to ensure patients receive the care they need. This work has the potential to improve utilization of health care resources and service delivery during natural disasters and emergencies, on a local, state, and regional level, with the overall goal of maintaining patient health and well-being.

Over the past decade, natural disasters and health care emergencies have increased 74%, averaging 400 documented events per year.¹ These unpredictable and sometimes devastating events negatively impact the physical and mental health of communities, taxing already stretched health care system resources and the economy.^2,3 During many of these events, patients inappropriately use hospitals, emergency departments (EDs), and critical care resources for chronic disease and elective health care management, resulting in medication shortages, health care access concerns, and treatment delays.⁴

Most available emergency preparedness programs rely solely on volunteers and/or public health providers to address the resultant coverage gap; however, instability in state and federal funding can make it difficult to maintain and sustain focused preparedness and response efforts. Alaska’s vast geography, low population density (1.2 people per square mile), and access limitations (about 200 villages only reachable by air or boat) make it especially challenging to provide reliable and sustained emergency preparedness and response support. Therefore, all eligible health care providers (HCPs) in Alaska must be involved in preparedness and response efforts.

Despite being the most accessible HCPs, pharmacists and student pharmacists, have not been actively involved in statewide emergency preparedness planning and disaster management efforts in Alaska. In preparation for and during disasters, for example, pharmacists may administer vaccinations, conduct point of care testing, dispense emergency medications, provide emergency medication refills, help mitigate medication shortages, and provide reliable health information to other health care professionals, patients, and their families as they prepare for and manage care during the event.⁴

The goal of this paper is to share the experience at the University of Alaska Anchorage/Idaho State University College of Pharmacy (UAA/ISU) in the development and implementation of a sustainable emergency preparedness and response support network (EPRSN) model; leveraging an established university student leadership structure and Doctor of Pharmacy (PharmD) students to support sharing of information among community pharmacies, state emergency response teams, and community members. 

2018 Alaska Earthquake

On November 30, 2018, southcentral Alaska experienced a magnitude 7.1 earthquake, affecting nearly 295,000 people (approximately 40% of Alaska’s population) damaging roads, buildings, homes, and health care facilities. Emergency response efforts were quickly overwhelmed and hospital EDs became overburdened with patients seeking not only emergent, but also chronic care along with requests for prescription refills.

During disasters, disruptions in medication access and adherence are common. Disruptions can lead to disease exacerbation or progression, hospitalization, and/or death; all of which further contribute to the health care system and economic health burden. For example, after Hurricane Katrina, 46% of patients on hypertension medications had less than perfect adherence due to a variety of reasons (eg, not bringing any or enough medications during evacuation, lack of access to refills).⁵ Nonadherence to prescription hypertension medication specifically can lead to stroke, heart attack, and more rapidly progressing kidney dysfunction. Patients with diabetes mellitus (DM) also experience negative consequences due to disruptions in medication adherence.⁶ Lack of access to medications and supplies for DM can likewise lead to significant health sequelae, including acute hyperglycemic events, which can be life-threatening; ongoing hyperglycemia can lead to higher rates of cardiovascular disease, kidney disease, nerve damage, and diabetic retinopathy.⁷ However, the long-term effects of a natural disaster on health in terms of morbidity and mortality often go unreported, and their impact on chronic health conditions may be underestimated and last for years after the event.

As future health care professionals, student pharmacists continually seek opportunities to engage with and support communities; including preparing for, responding to, mitigating against, and recovering from disasters that affect the health care system and access to needed drug therapies. After the earthquake, student pharmacists reached out to state and local emergency response programs detailed within The State of Alaska Emergency Operations Plan to find opportunities to volunteer.

Agencies contacted included the Office of Emergency Management (OEM) for the Municipality of Anchorage. OEM partners with local health, fire, and police departments, the Alaska Department of Health and Social Services and Emergency Management, the Federal Emergency Management Agency, Centers for Disease Control and Prevention, American Red Cross, and the Salvation Army. It is important to note, due to lack of funding, Alaska no longer has a Medical Reserve Corps, which significantly impacts community emergency response and resilience efforts. After the earthquake, the emergency program manager extended an invitation to student pharmacists to join the joint medical emergency conference call, where local HCPs discuss emergency protocols, identify gaps, and work together to identify solutions.

During this call there was a consensus among HCPs that many patients were inappropriately seeking to fill and refill prescription medications in the ED, and staff were ill-prepared to guide patients to the appropriate services, unaware of which pharmacies were impacted by the earthquake; therefore unable to direct patients to still-operational pharmacies in the area. Together faculty and students discussed how student pharmacists could be involved in filling these identified information gaps and enhance communication among HCPs and entities. It was determined that if student pharmacists established and maintained open lines of communication with community pharmacists, they could efficiently determine which pharmacies were open and operational after disasters and disseminate that information to EDs and health care facilities in order to better direct patients to appropriate health care services.

Observations 

A question/answer format and time line approach was used to review the steps leading to EPRSN program development and establishment of project/model deliverables.

Identified gaps

Chronic disease management. According to interviews conducted by the National Center for Disaster Preparedness, people often inappropriately use EDs during disasters.⁸ EDs do not stock enough medications to refill prescriptions for patients outside of their emergent care needs and are typically ill-suited for patients’ chronic disease management. At the time of the earthquake in Alaska no specific place/organization had been established to collect, store, or disseminate information regarding available pharmacy resources in an emergency. Had such a system been in place to actively inform HCPs and community members which pharmacies were open and operational, it is likely that many negative consequences related to health care utilization could have been reduced or avoided, including the number of people inappropriately using EDs for chronic prescription medication refills. This would not only reduce the burden on the health care system but allow for patients with both emergency and chronic needs to be seen quickly and prevent unnecessary health care costs.

Pharmacists play a vital role in managing chronic diseases.⁹ Due to extensive education and training, they are considered medication experts, ideally suited to manage chronic medication therapy, help prevent or minimize disease exacerbation and/or progression, reduce preventable health care costs, improve patient quality of life, and reduce morbidity and mortality.⁹ Pharmacists are accessible and strategically located throughout communities and provide patients with continuity of care other HCPs may be unable to provide. For example, during the COVID-19 pandemic, pharmacies remained open when other primary care providers (PCPs) were not. In addition, during times of natural disasters pharmacies tend to remain open unless there are extenuating circumstances (eg, unsafe building infrastructure, unsafe drug supply).

Emergency Response. To determine the role pharmacists play in emergency preparedness efforts we looked initially to the peer-reviewed literature (search terms: emergency preparedness, natural disasters, pharmacy/pharmacies) then turned to materials and research produced by organizations outside of the traditional commercial and academic publishing channels; however, most emergency preparedness protocols and standard operating procedures (SOPs) did not pertain to pharmacies or acknowledge the contribution of pharmacists. Researchers urge both state and federal governments to foster relationships with and use community pharmacist’s expertise and expanded roles in order to improve the nation’s public health.¹⁰

Historically, pharmacists within the US Public Health Service (PHS) have responded alongside local HCPs to meet the needs of communities during public health emergencies. Pharmacists were pivotal in the 2009 response to H1N1 influenza and the 2015 Ebola response, both abroad and within the United States.⁶ Pharmacists screened and triaged patients, provided life-saving vaccinations, and supported community and health care system education initiatives. However, as the COVID-19 pandemic has demonstrated, responding to a public health crisis takes more than the 1,000 pharmacists serving in the PHS.¹¹ The American Society of Health-System Pharmacists argues that all pharmacists should be involved in working with public health planners.¹²

Community and health-systems pharmacists are vital to current and future public health responses and represent a largely untapped resource. Pharmacists across the country, especially in rural and underserved communities, have the potential to significantly impact emergency preparedness and response efforts. The > 319,000 US pharmacists comprise a sizable portion of the population and can play vital roles during emergency situations or disasters.¹³ Often after catastrophic events, community pharmacists provide first-aid, emergency refills, medication counseling, point of care testing, triage patients and serve on emergency response teams.¹⁴ However, pharmacists alone cannot address all medication-related patient needs and student pharmacists likewise have a role in emergency preparedness and response efforts. By participating in these efforts and learning these roles as students, they are better prepared to engage in emergency efforts as pharmacists.

Student pharmacist support. There are more than 140 accredited pharmacy schools across the United States, employing > 6,500 pharmacy faculty, and teaching > 63,000 student pharmacists.¹⁵ The majority of schools provide free and volunteer-based health care services and collaborate with local, regional, and national entities such as state boards of pharmacy, professional pharmacy organizations, and the American Pharmacist Association (APhA). Through the APhA Academy of Student Pharmacists (ASP), in 2018 and 2019 Operation Heart Campaign, 4,239 patients were referred to a PCP for follow-up care, 117,251 patients received health and wellness services, and 2,772,179 patients were educated regarding cardiovascular disease, the most common noncommunicable disease in the United States.^16,17 Also, in 2018 and 2019, APhA-ASPs Operation Diabetes Campaign referred 3,785 patients to their PCP, provided health and wellness services to 36,334 patients, and educated 1,114,281 patients regarding DM.¹⁸

Student pharmacists are positioned across the country with reach to rural and underserved communities and have student organizational structures in place to manage student volunteers and support health care service opportunities. These structures could readily be used to augment and provide emergency pharmacy services and the coordination of chronic care services during times of emergency or disaster. Student leaders are well situated to coordinate communication and cooperation across health care disciplines and to facilitate local community pharmacy resource information collection and distribution.

Emergency Preparation Program

To address gaps in emergency preparedness and response, student pharmacists at UAA/ISU took the following steps to develop the EPRSN. Planning involved a multistep process. Step 1 identified important uncaptured data (eg, operational status, staffing, hours of operation, continuity and safety of drug supply chain, building/parking lot damage) required to direct patients to the appropriate medication-related care during an emergency. For step 2, student pharmacists obtained a list of the 138 pharmacies in Alaska from the state board of pharmacy. Pharmacies were contacted by student pharmacists using an established telephone script and updated contact information collected was stored on a secure, online drive accessible to UAA/ISU College of Pharmacy faculty and students using their UAA/ISU email address. In step 3, the APhA-ASP president elect and 3 leaders in each of the 16 APhA-ASP operation in charge of the EPRSN Alaska initiative, surveyed student leaders to determine student willingness to participate. Step 4 was to develop an organizational structure using established leadership structure to collect, capture, update, and share pharmacy data with state emergency response teams. Sustainability from year to year will be ensured through incorporation into the APhA-ASP student engagement framework (eg, annual training led by the president elect, contact information updated biyearly by student leaders, and oversight provided by College of Pharmacy faculty). Step 5 was to create SOPs, flowcharts, telephone scripts, talking points, and student training materials. And in the final preparatory step, plan documents and deliverables were provided to faculty administration and advisors within the College of Pharmacy for initial approval and presented to the student leadership for final approval.

EPRSN will be activated in the case of a natural disaster or state of emergency. Pharmacy students will contact all pharmacies within the designated area to collect up-to-date vital information (eg, operational status, staffing, hours of operation, safe drug supply, building/parking lot damage). Collected information will be disseminated to appropriate community members, HCPs, health care facilities, and emergency preparedness officials, under the direction of the Emergency Program Manager. 

Discussion

In order to make informed and timely decisions during emergency situations, patients, HCPs, and health care systems must have appropriate situational awareness. The ability of decision makers to respond is directly dependent on timeliness and relevance of the information collected and shared and greatly contributes to this awareness. Accurate, effective, and consistent information collection has historically been one of the greatest challenges to situational awareness. This is particularly important in times of disaster when necessary emergency situation data may not exist, tools to collect data are inefficient and/or ineffective, and/or current data are inaccessible to relevant parties.¹⁹ This was the case in the Alaska earthquake of 2018 and more recently the COVID-19 pandemic of 2020 where information sharing deficits and structural barriers became even more evident.  

Transfer of knowledge and information is especially critical during an emergency situation. Ineffective communication and information sharing results in transfer gaps. Gaps that result from inadequate transfers of care between HCPs are referred to as hand-off gaps. Training gaps result from inadequate preparation on the part of HCPs and civic leaders as well as in public health policies and procedures and in understanding of needs in emergent situations. Organization gaps occur when an individual changes positions or leaves a given institution and the acquired knowledge is not shared with others before departure or the replacement individual does not receive necessary training. 

In both the Alaska earthquake and the COVID-19 pandemic, gaps in hand-offs, training, and organization were identified. Pharmacists were involved in the solution, providing care, addressing unmet health needs, and supporting the health care system. Many patients and HCPs remain unaware of the services pharmacists are capable and willing to provide, but at even a more basic level they are unsure of what services may be needed in emergency situations. Pharmacists are often used and considered vital HCPs after natural disasters or emergency situations, providing services that extend beyond their normal duties, yet remain within their SOP and expertise and address the medication management needs of their patients, ensuring safe, effective, and continuous access to needed pharmaceuticals.

It is vital that pharmacists and student pharmacists take an active role in emergency preparedness, that students get involved early in outreach and engagement initiatives for which they are ideally suited to coordinate in their communities, and that College of Pharmacy faculty support student pharmacist efforts to continue to highlight the professional roles of pharmacists, in routine health care as well as during times of crisis or disaster. It is important to note that an indirect but important cause of patient mortality related to an emergency event is the inability to access routine health care. If pharmacists and student pharmacists were more involved in emergency preparedness and response efforts, they could play an even greater role in providing much needed health care to patients during times when the health care system is overtaxed (facilitating medication refills and providing administrative and health care support).

Conclusions

Emergency and disaster preparedness are vital to promote the appropriate use of health care resources and prevent health-related complications. Student pharmacists represent a sustainable resource, uniquely positioned to identify community needs, support emergency efforts, coordinate with local pharmacies, and work with pharmacists and others to ensure patients receive the care they need. This work has the potential to improve utilization of health care resources and service delivery during natural disasters and emergencies, on a local, state, and regional level, with the overall goal of maintaining patient health and well-being.

Protection against norovirus gastroenteritis is supported in part by norovirus-specific CD8+ T cells that reside in peripheral, intestinal, and lymphoid tissues, according to investigators.

These findings, and the molecular tools used to discover them, could guide development of a norovirus vaccine and novel cellular therapies, according to lead author Ajinkya Pattekar, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

“Currently, there are no approved pharmacologic therapies against norovirus, and despite several promising clinical trials, an effective vaccine is not available,” the investigators wrote in Cellular and Molecular Gastroenterology and Hepatology, which may stem from an incomplete understanding of norovirus immunity, according to Dr. Pattekar and colleagues.

They noted that most previous research has focused on humoral immunity, which appears variable between individuals, with some people exhibiting a strong humoral response, while others mount only partial humoral protection. The investigators also noted that, depending on which studies were examined, this type of defense could last years or fade within weeks to months and that “immune mechanisms other than antibodies may be important for protection against noroviruses.”

Specifically, cellular immunity may be at work. A 2020 study involving volunteers showed that T cells were cross-reactive to a type of norovirus the participants had never been exposed to.

“These findings suggest that T cells may target conserved epitopes and could offer cross-protection against a broad range of noroviruses,” Dr. Pattekar and colleagues wrote.

To test this hypothesis, they first collected peripheral blood mononuclear cells (PBMCs) from three healthy volunteers with unknown norovirus exposure history. Then serum samples were screened for norovirus functional antibodies via the binding between virus-like particles (VLPs) and histo–blood group antigens (HBGAs). This revealed disparate profiles of blocking antibodies against various norovirus strains. While donor 1 and donor 2 had antibodies against multiple strains, donor 3 lacked norovirus antibodies. Further testing showed that this latter individual was a nonsecretor with limited exposure history.

Next, the investigators tested donor PBMCs for norovirus-specific T-cell responses with use of overlapping libraries of peptides for each of the three norovirus open reading frames (ORF1, ORF2, and ORF3). T-cell responses, predominantly involving CD8+ T cells, were observed in all donors. While donor 1 had the greatest response to ORF1, donors 2 and 3 had responses that focused on ORF2.

“Thus, norovirus-specific T cells targeting ORF1 and ORF2 epitopes are present in peripheral blood from healthy donors regardless of secretor status,” the investigators wrote.

To better characterize T-cell epitopes, the investigators subdivided the overlapping peptide libraries into groups of shorter peptides, then exposed serum to these smaller component pools. This revealed eight HLA class I restricted epitopes that were derived from a genogroup II.4 pandemic norovirus strain; this group of variants has been responsible for all six of the norovirus pandemics since 1996.

Closer examination of the epitopes showed that they were “broadly conserved beyond GII.4.” Only one epitope exhibited variation in the C-terminal aromatic anchor, and it was nondominant. The investigators therefore identified seven immunodominant CD8+ epitopes, which they considered “valuable targets for vaccine and cell-based therapies.

“These data further confirm that epitope-specific CD8+ T cells are a universal feature of the overall norovirus immune response and could be an attractive target for future vaccines,” the investigators wrote.

Additional testing involving samples of spleen, mesenteric lymph nodes, and duodenum from deceased individuals showed presence of norovirus-specific CD8+ T cells, with particular abundance in intestinal tissue, and distinct phenotypes and functional properties in different tissue types.

“Future studies using tetramers and intestinal samples should build on these observations and fully define the location and microenvironment of norovirus-specific T cells,” the investigators wrote. “If carried out in the context of a vaccine trial, such studies could be highly valuable in elucidating tissue-resident memory correlates of norovirus immunity.”

The study was funded by the National Institutes of Health, the Wellcome Trust, and Deutsche Forschungsgemeinschaft. The investigators reported no conflicts of interest.

Protection against norovirus gastroenteritis is supported in part by norovirus-specific CD8+ T cells that reside in peripheral, intestinal, and lymphoid tissues, according to investigators.

These findings, and the molecular tools used to discover them, could guide development of a norovirus vaccine and novel cellular therapies, according to lead author Ajinkya Pattekar, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

“Currently, there are no approved pharmacologic therapies against norovirus, and despite several promising clinical trials, an effective vaccine is not available,” the investigators wrote in Cellular and Molecular Gastroenterology and Hepatology, which may stem from an incomplete understanding of norovirus immunity, according to Dr. Pattekar and colleagues.

They noted that most previous research has focused on humoral immunity, which appears variable between individuals, with some people exhibiting a strong humoral response, while others mount only partial humoral protection. The investigators also noted that, depending on which studies were examined, this type of defense could last years or fade within weeks to months and that “immune mechanisms other than antibodies may be important for protection against noroviruses.”

Specifically, cellular immunity may be at work. A 2020 study involving volunteers showed that T cells were cross-reactive to a type of norovirus the participants had never been exposed to.

“These findings suggest that T cells may target conserved epitopes and could offer cross-protection against a broad range of noroviruses,” Dr. Pattekar and colleagues wrote.

To test this hypothesis, they first collected peripheral blood mononuclear cells (PBMCs) from three healthy volunteers with unknown norovirus exposure history. Then serum samples were screened for norovirus functional antibodies via the binding between virus-like particles (VLPs) and histo–blood group antigens (HBGAs). This revealed disparate profiles of blocking antibodies against various norovirus strains. While donor 1 and donor 2 had antibodies against multiple strains, donor 3 lacked norovirus antibodies. Further testing showed that this latter individual was a nonsecretor with limited exposure history.

Next, the investigators tested donor PBMCs for norovirus-specific T-cell responses with use of overlapping libraries of peptides for each of the three norovirus open reading frames (ORF1, ORF2, and ORF3). T-cell responses, predominantly involving CD8+ T cells, were observed in all donors. While donor 1 had the greatest response to ORF1, donors 2 and 3 had responses that focused on ORF2.

“Thus, norovirus-specific T cells targeting ORF1 and ORF2 epitopes are present in peripheral blood from healthy donors regardless of secretor status,” the investigators wrote.

To better characterize T-cell epitopes, the investigators subdivided the overlapping peptide libraries into groups of shorter peptides, then exposed serum to these smaller component pools. This revealed eight HLA class I restricted epitopes that were derived from a genogroup II.4 pandemic norovirus strain; this group of variants has been responsible for all six of the norovirus pandemics since 1996.

Closer examination of the epitopes showed that they were “broadly conserved beyond GII.4.” Only one epitope exhibited variation in the C-terminal aromatic anchor, and it was nondominant. The investigators therefore identified seven immunodominant CD8+ epitopes, which they considered “valuable targets for vaccine and cell-based therapies.

“These data further confirm that epitope-specific CD8+ T cells are a universal feature of the overall norovirus immune response and could be an attractive target for future vaccines,” the investigators wrote.

Additional testing involving samples of spleen, mesenteric lymph nodes, and duodenum from deceased individuals showed presence of norovirus-specific CD8+ T cells, with particular abundance in intestinal tissue, and distinct phenotypes and functional properties in different tissue types.

“Future studies using tetramers and intestinal samples should build on these observations and fully define the location and microenvironment of norovirus-specific T cells,” the investigators wrote. “If carried out in the context of a vaccine trial, such studies could be highly valuable in elucidating tissue-resident memory correlates of norovirus immunity.”

The study was funded by the National Institutes of Health, the Wellcome Trust, and Deutsche Forschungsgemeinschaft. The investigators reported no conflicts of interest.

Protection against norovirus gastroenteritis is supported in part by norovirus-specific CD8+ T cells that reside in peripheral, intestinal, and lymphoid tissues, according to investigators.

These findings, and the molecular tools used to discover them, could guide development of a norovirus vaccine and novel cellular therapies, according to lead author Ajinkya Pattekar, MD, of the University of Pennsylvania, Philadelphia, and colleagues.

“Currently, there are no approved pharmacologic therapies against norovirus, and despite several promising clinical trials, an effective vaccine is not available,” the investigators wrote in Cellular and Molecular Gastroenterology and Hepatology, which may stem from an incomplete understanding of norovirus immunity, according to Dr. Pattekar and colleagues.

They noted that most previous research has focused on humoral immunity, which appears variable between individuals, with some people exhibiting a strong humoral response, while others mount only partial humoral protection. The investigators also noted that, depending on which studies were examined, this type of defense could last years or fade within weeks to months and that “immune mechanisms other than antibodies may be important for protection against noroviruses.”

Specifically, cellular immunity may be at work. A 2020 study involving volunteers showed that T cells were cross-reactive to a type of norovirus the participants had never been exposed to.

“These findings suggest that T cells may target conserved epitopes and could offer cross-protection against a broad range of noroviruses,” Dr. Pattekar and colleagues wrote.

To test this hypothesis, they first collected peripheral blood mononuclear cells (PBMCs) from three healthy volunteers with unknown norovirus exposure history. Then serum samples were screened for norovirus functional antibodies via the binding between virus-like particles (VLPs) and histo–blood group antigens (HBGAs). This revealed disparate profiles of blocking antibodies against various norovirus strains. While donor 1 and donor 2 had antibodies against multiple strains, donor 3 lacked norovirus antibodies. Further testing showed that this latter individual was a nonsecretor with limited exposure history.

Next, the investigators tested donor PBMCs for norovirus-specific T-cell responses with use of overlapping libraries of peptides for each of the three norovirus open reading frames (ORF1, ORF2, and ORF3). T-cell responses, predominantly involving CD8+ T cells, were observed in all donors. While donor 1 had the greatest response to ORF1, donors 2 and 3 had responses that focused on ORF2.

“Thus, norovirus-specific T cells targeting ORF1 and ORF2 epitopes are present in peripheral blood from healthy donors regardless of secretor status,” the investigators wrote.

To better characterize T-cell epitopes, the investigators subdivided the overlapping peptide libraries into groups of shorter peptides, then exposed serum to these smaller component pools. This revealed eight HLA class I restricted epitopes that were derived from a genogroup II.4 pandemic norovirus strain; this group of variants has been responsible for all six of the norovirus pandemics since 1996.

Closer examination of the epitopes showed that they were “broadly conserved beyond GII.4.” Only one epitope exhibited variation in the C-terminal aromatic anchor, and it was nondominant. The investigators therefore identified seven immunodominant CD8+ epitopes, which they considered “valuable targets for vaccine and cell-based therapies.

“These data further confirm that epitope-specific CD8+ T cells are a universal feature of the overall norovirus immune response and could be an attractive target for future vaccines,” the investigators wrote.

Additional testing involving samples of spleen, mesenteric lymph nodes, and duodenum from deceased individuals showed presence of norovirus-specific CD8+ T cells, with particular abundance in intestinal tissue, and distinct phenotypes and functional properties in different tissue types.

“Future studies using tetramers and intestinal samples should build on these observations and fully define the location and microenvironment of norovirus-specific T cells,” the investigators wrote. “If carried out in the context of a vaccine trial, such studies could be highly valuable in elucidating tissue-resident memory correlates of norovirus immunity.”

The study was funded by the National Institutes of Health, the Wellcome Trust, and Deutsche Forschungsgemeinschaft. The investigators reported no conflicts of interest.

The United States continues to confront an opioid crisis that also affects older adults. According to the Substance Abuse and Mental Health Services Administration from 1999 to 2010, there has been a 4-fold increase in opioid overdose deaths.¹ Between 2010 and 2015, the rate of opioid-related inpatient stays and emergency department (ED) visits for people aged ≥ 65 years increased by 34% and 74%, respectively, and opioid-related overdose deaths continue to increase among older patients.^1,2

Background

Chronic pain is estimated to affect 50 million US adults.³ Individuals receiving long-term opioid therapy may not have experienced relief with other medications or cannot take them for medical safety reasons. Losing access to opioid prescriptions can contribute to misuse of illicit opioids. Implementing best practices for prescription opioid management in older adults is challenging. Older adults have a high prevalence of chronic pain, which is linked to disability and loss of function, reduced mobility, falls, depression, anxiety, sleep disorders, social isolation, and suicide or suicidal ideation.⁴ Until recently, chronic pain in older adults was often treated primarily with long-term opioid prescriptions, despite little evidence for the effectiveness of that treatment for chronic conditions. The prevalence of long-term opioid use in adults has increased from 1.8% (1999-2000) to 5.4% (2013-2014), and 25% of adult long-term opioid users are aged ≥ 65 years.⁵

Older adults are especially vulnerable to developing adverse events (AEs) from opioid use, including constipation, confusion, nausea, falls, and overdose. These factors make safe prescribing more challenging even when opioids are an appropriate therapeutic choice. Older adults often have multiple chronic conditions and take multiple medications that increase risk of AEs due to drug-disease and drug-drug interactions. Finding appropriate alternatives for pain management can be challenging in the presence of dementia if other pharmacologic options are contraindicated or mobility issues limit access to other therapeutic options.

Pain treatment plans should be based on realistic functional goals using a shared decision-making approach accounting for patient and provider expectations. All reasonable nondrug and nonopioid treatments should be considered before opioids are initiated. A comprehensive, person-centered, approach to pain management in older adults that includes opioids, other medications, and complementary and integrative care could improve both pain control and function,and reduce the harms of unnecessary opioid exposure.⁶ A validated risk review should be performed and documented on all patients starting opioids except patients enrolled in hospice care.

In 2018, the US Department of Veterans Affairs (VA) required all facilities to complete case reviews for veterans identified in the Stratification Tool for Opioid Risk Mitigation (STORM) dashboard as being at particularly high risk for AEs among patients prescribed opioids.⁷ We present our experience with a 1-year management of 48 high-risk older patients receiving chronic prescription opioid therapy. These patients obtained all their care at the VA with complete record documentation.

Methods

The Tennessee Valley Healthcare System (TVHS) is an integrated VA health care system with > 100,000 veteran patients in middle Tennessee with 2 medical centers 40 miles apart, and 12 community-based outpatient clinics. In 2011, TVHS developed a geriatric patient-centered medical home model for geriatric primary care—the geriatric patient aligned care team (GeriPACT).⁸ GeriPACT consists of a GeriPACT primary care provider (geriatrician or geriatric nurse practitioner with a panel of about 800 outpatients), social worker, clinical pharmacist, registered nurse care manager, licensed vocational nurse, and clerical staff. GeriPACT is a special population PACT within primary care for complex geriatric and other high-risk vulnerable veterans providing integrated, interdisciplinary assessment and longitudinal management, and coordination of both VA and non-VA-funded (eg, Medicare and Medicaid) services for patients and caregivers. GeriPACT at the Nashville TVHS campus has an enrollment of 745 patients of whom 48 receive chronic prescription opioid therapy. The practice is supported by the VA Computerized Patients Record System (CPRS), including the electronic patient portal, My healtheVet, with telemedicine capabilities. Data were collected by chart review with operations data extracted from the Veterans Health Information System and Technology Architecture.

Best practices for prescription opioids for chronic pain follow the US Department of Health and Human Services Interagency Task Force pain management recommendations.⁴ These include: (1) Effective pain evaluation and management, including diagnostic evaluation and indicated referrals; (2) appropriately prescribed opioids when indicated; and (3) active management of opioid users to prevent AEs and misuse. Strategies used in GeriPACT were adopted from the pain management task force and designed to address needs and challenges associated with responsible chronic opioid prescribing (Table 1).

Results

Chronic opioid patients comprised 6.4% of the GeriPACT population. These patients had many comorbidities, including diabetes mellitus (35%), pulmonary disease (25%), congestive heart failure (18.8%), and dementia (8%). There were 54% with estimated glomerular filtration rates (eGFR) < 60 mL/min, indicating at least stage 3 chronic kidney disease (Table 2). Patients had an average RIOSORD Score of 21 and a 14% risk of opioid induced respiratory depression, and 20% received mental health services.

The mean CAN score was 83.1, suggesting a 1-year risk of 20% for a major AE and 5% mortality risk. Many patients with chronic opioid use were transferred to GeriPACT from primary care due to presence of complex medical issues in addition to need for chronic pain management. In this population, 8% were coprescribed benzodiazepines and opioids. Consults were obtained from interventional pain for 37.5% of patients and palliative care for 27% of patients, the majority for goals of care related to chronic illness and advance directive discussions, and in 1 patient for pain and symptom management. The majority of patients (81%) had advance care planning documents or discussions documented in the electronic health record, and 87.5% of patients received home and community-based support in addition to GeriPACT care.

Medication Reduction

Pharmacists routinely counseled patients regarding the appropriate timing of refills and made monthly calls to request refills of controlled drugs. Three patients agreed to opioid dose reduction due to improved clinical status. Two patients had 25% and 30% dose reductions, respectively, and 1 patient was able to be discontinue opioids. This was achieved through reduction of therapy and or substitution of alternative nonopioid pain medications. One patient was initiated on a slow benzodiazepine taper schedule after decades of benzodiazepine use in addition to engagement with a whole health coach and primary care mental health integration provider. Another patient was disenrolled from the clinic because of repeated nonadherence and positive UDSs for polysubstance use disorder.

Accidental Overdoses

There were 2 patients with accidental overdoses who survived, both on high morphine equivalent daily doses (MEDDs). One patient was admitted to the intensive care unit for increasing confusion after taking more than the prescribed opioids (120 mg MEDD) due to uncontrolled pain for 2 months following surgery. The second patient was taking 66 mg MEDD with multiple risk factors for respiratory depression (severe chronic obstructive pulmonary disease requiring oxygen, obstructive sleep apnea, and concomitant benzodiazepine use) who repeatedly refused tapering of opioids and benzodiazepines. He was found unresponsive in respiratory depression by home health staff. Both patients had naloxone kits in their home that were not administered.

Urine Drug Screening

There was an occasional negative opioid UDS attributed to patients on a low-dose opioid administered more than 24 hours before. Five patients (10.4%) had positive UDSs. Two patients were positive for cocaine, and because of chronic persistent pain and complex medical problems cared for in the clinic, counseled and continued on therapy with no repeat infractions. Two patients were positive for cannabinoids attributed to CBD oil products, which are legal in Tennessee. One patient had repeated positive UDSs for polysubstance abuse and was terminated from the clinic, preferring to use cannabinoids and other substances illegally. Meperidine, fentanyl, tramadol, and other synthetic opioids are not detected on a routine UDS.

Discussion

Primary care is critical in optimizing the prescribing and use of opioids in older adults. The patient-centered medical home can give health care providers the tools and support to provide evidence—based pain management for their older adult patients and to facilitate prescription and monitoring of appropriate opioid use to minimizing AEs and OUD risk. This includes a reliable health information technology monitoring system as part of a collaborative, person-centered care practice capable of managing frail older patients with multiple chronic conditions as well as social risk factors. GeriPACT was able to implement guideline—based evaluation and treatment of chronic pain patients through optimal management of opioids, risk reduction, and monitoring and management of AEs, misuse, and dose tapering using shared decision-making strategies when appropriate.

Complex older patients on chronic opioid treatment can do well and are best managed by an interdisciplinary team. Our panel had a high prevalence of chronic opioid patients and a high expected mortality based on the severity of comorbidities. Patients had frequent access to care with utilization of many support services. Patients received care for many chronic illnesses at the same time they received opioid therapy and generally were satisfied and adherent to their treatment plan. Published reports of the prevalence of coprescribing of benzodiazepines and opioids of 1.1 to 2.7% in the general population, may be lower than our veteran population.¹⁴ Despite the fact that nearly 20% of the population had a history of opioid misuse, only 1 patient was terminated from the clinic because of repeated episodes of polysubstance use disorder.

GeriPACT has the capability to be responsive to the changing needs of older chronic pain patients as a learning health system using continuous process improvement with frequent team meetings and interdisciplinary care.¹⁵ Our experience with chronic pain management demonstrates the feasibility and quality of guideline-based management and enhances our understanding of the intersection of care, chronic pain management, and opioid use disorder in older adults.

Limitations

Our experience with this population of older veterans may not be applicable to other geriatric populations. While all patients received their primary care at VA and patients were seen regularly, our data may not account for possible use of some community services, including hospitalization and long-term care.

Conclusions

Guideline-based patient-centered medical home management of patients with chronic pain treated with opioids can be an effective model to maintain and improve measures of health and well-being in older patients. Primary care management is critical in optimizing the prescribing and use of opioids in older adults. These complex older patients are best managed by an interdisciplinary team.

Acknowledgments

This work was supported in part by the Geriatric Workforce Enhancement Program, HRSA Grant: 1-U1Q-HP 033085-01-00.

The United States continues to confront an opioid crisis that also affects older adults. According to the Substance Abuse and Mental Health Services Administration from 1999 to 2010, there has been a 4-fold increase in opioid overdose deaths.¹ Between 2010 and 2015, the rate of opioid-related inpatient stays and emergency department (ED) visits for people aged ≥ 65 years increased by 34% and 74%, respectively, and opioid-related overdose deaths continue to increase among older patients.^1,2

Background

Chronic pain is estimated to affect 50 million US adults.³ Individuals receiving long-term opioid therapy may not have experienced relief with other medications or cannot take them for medical safety reasons. Losing access to opioid prescriptions can contribute to misuse of illicit opioids. Implementing best practices for prescription opioid management in older adults is challenging. Older adults have a high prevalence of chronic pain, which is linked to disability and loss of function, reduced mobility, falls, depression, anxiety, sleep disorders, social isolation, and suicide or suicidal ideation.⁴ Until recently, chronic pain in older adults was often treated primarily with long-term opioid prescriptions, despite little evidence for the effectiveness of that treatment for chronic conditions. The prevalence of long-term opioid use in adults has increased from 1.8% (1999-2000) to 5.4% (2013-2014), and 25% of adult long-term opioid users are aged ≥ 65 years.⁵

Older adults are especially vulnerable to developing adverse events (AEs) from opioid use, including constipation, confusion, nausea, falls, and overdose. These factors make safe prescribing more challenging even when opioids are an appropriate therapeutic choice. Older adults often have multiple chronic conditions and take multiple medications that increase risk of AEs due to drug-disease and drug-drug interactions. Finding appropriate alternatives for pain management can be challenging in the presence of dementia if other pharmacologic options are contraindicated or mobility issues limit access to other therapeutic options.

Pain treatment plans should be based on realistic functional goals using a shared decision-making approach accounting for patient and provider expectations. All reasonable nondrug and nonopioid treatments should be considered before opioids are initiated. A comprehensive, person-centered, approach to pain management in older adults that includes opioids, other medications, and complementary and integrative care could improve both pain control and function,and reduce the harms of unnecessary opioid exposure.⁶ A validated risk review should be performed and documented on all patients starting opioids except patients enrolled in hospice care.

In 2018, the US Department of Veterans Affairs (VA) required all facilities to complete case reviews for veterans identified in the Stratification Tool for Opioid Risk Mitigation (STORM) dashboard as being at particularly high risk for AEs among patients prescribed opioids.⁷ We present our experience with a 1-year management of 48 high-risk older patients receiving chronic prescription opioid therapy. These patients obtained all their care at the VA with complete record documentation.

Methods

The Tennessee Valley Healthcare System (TVHS) is an integrated VA health care system with > 100,000 veteran patients in middle Tennessee with 2 medical centers 40 miles apart, and 12 community-based outpatient clinics. In 2011, TVHS developed a geriatric patient-centered medical home model for geriatric primary care—the geriatric patient aligned care team (GeriPACT).⁸ GeriPACT consists of a GeriPACT primary care provider (geriatrician or geriatric nurse practitioner with a panel of about 800 outpatients), social worker, clinical pharmacist, registered nurse care manager, licensed vocational nurse, and clerical staff. GeriPACT is a special population PACT within primary care for complex geriatric and other high-risk vulnerable veterans providing integrated, interdisciplinary assessment and longitudinal management, and coordination of both VA and non-VA-funded (eg, Medicare and Medicaid) services for patients and caregivers. GeriPACT at the Nashville TVHS campus has an enrollment of 745 patients of whom 48 receive chronic prescription opioid therapy. The practice is supported by the VA Computerized Patients Record System (CPRS), including the electronic patient portal, My healtheVet, with telemedicine capabilities. Data were collected by chart review with operations data extracted from the Veterans Health Information System and Technology Architecture.

Best practices for prescription opioids for chronic pain follow the US Department of Health and Human Services Interagency Task Force pain management recommendations.⁴ These include: (1) Effective pain evaluation and management, including diagnostic evaluation and indicated referrals; (2) appropriately prescribed opioids when indicated; and (3) active management of opioid users to prevent AEs and misuse. Strategies used in GeriPACT were adopted from the pain management task force and designed to address needs and challenges associated with responsible chronic opioid prescribing (Table 1).

Results

Chronic opioid patients comprised 6.4% of the GeriPACT population. These patients had many comorbidities, including diabetes mellitus (35%), pulmonary disease (25%), congestive heart failure (18.8%), and dementia (8%). There were 54% with estimated glomerular filtration rates (eGFR) < 60 mL/min, indicating at least stage 3 chronic kidney disease (Table 2). Patients had an average RIOSORD Score of 21 and a 14% risk of opioid induced respiratory depression, and 20% received mental health services.

The mean CAN score was 83.1, suggesting a 1-year risk of 20% for a major AE and 5% mortality risk. Many patients with chronic opioid use were transferred to GeriPACT from primary care due to presence of complex medical issues in addition to need for chronic pain management. In this population, 8% were coprescribed benzodiazepines and opioids. Consults were obtained from interventional pain for 37.5% of patients and palliative care for 27% of patients, the majority for goals of care related to chronic illness and advance directive discussions, and in 1 patient for pain and symptom management. The majority of patients (81%) had advance care planning documents or discussions documented in the electronic health record, and 87.5% of patients received home and community-based support in addition to GeriPACT care.

Medication Reduction

Pharmacists routinely counseled patients regarding the appropriate timing of refills and made monthly calls to request refills of controlled drugs. Three patients agreed to opioid dose reduction due to improved clinical status. Two patients had 25% and 30% dose reductions, respectively, and 1 patient was able to be discontinue opioids. This was achieved through reduction of therapy and or substitution of alternative nonopioid pain medications. One patient was initiated on a slow benzodiazepine taper schedule after decades of benzodiazepine use in addition to engagement with a whole health coach and primary care mental health integration provider. Another patient was disenrolled from the clinic because of repeated nonadherence and positive UDSs for polysubstance use disorder.

Accidental Overdoses

There were 2 patients with accidental overdoses who survived, both on high morphine equivalent daily doses (MEDDs). One patient was admitted to the intensive care unit for increasing confusion after taking more than the prescribed opioids (120 mg MEDD) due to uncontrolled pain for 2 months following surgery. The second patient was taking 66 mg MEDD with multiple risk factors for respiratory depression (severe chronic obstructive pulmonary disease requiring oxygen, obstructive sleep apnea, and concomitant benzodiazepine use) who repeatedly refused tapering of opioids and benzodiazepines. He was found unresponsive in respiratory depression by home health staff. Both patients had naloxone kits in their home that were not administered.

Urine Drug Screening

There was an occasional negative opioid UDS attributed to patients on a low-dose opioid administered more than 24 hours before. Five patients (10.4%) had positive UDSs. Two patients were positive for cocaine, and because of chronic persistent pain and complex medical problems cared for in the clinic, counseled and continued on therapy with no repeat infractions. Two patients were positive for cannabinoids attributed to CBD oil products, which are legal in Tennessee. One patient had repeated positive UDSs for polysubstance abuse and was terminated from the clinic, preferring to use cannabinoids and other substances illegally. Meperidine, fentanyl, tramadol, and other synthetic opioids are not detected on a routine UDS.

Discussion

Primary care is critical in optimizing the prescribing and use of opioids in older adults. The patient-centered medical home can give health care providers the tools and support to provide evidence—based pain management for their older adult patients and to facilitate prescription and monitoring of appropriate opioid use to minimizing AEs and OUD risk. This includes a reliable health information technology monitoring system as part of a collaborative, person-centered care practice capable of managing frail older patients with multiple chronic conditions as well as social risk factors. GeriPACT was able to implement guideline—based evaluation and treatment of chronic pain patients through optimal management of opioids, risk reduction, and monitoring and management of AEs, misuse, and dose tapering using shared decision-making strategies when appropriate.

Complex older patients on chronic opioid treatment can do well and are best managed by an interdisciplinary team. Our panel had a high prevalence of chronic opioid patients and a high expected mortality based on the severity of comorbidities. Patients had frequent access to care with utilization of many support services. Patients received care for many chronic illnesses at the same time they received opioid therapy and generally were satisfied and adherent to their treatment plan. Published reports of the prevalence of coprescribing of benzodiazepines and opioids of 1.1 to 2.7% in the general population, may be lower than our veteran population.¹⁴ Despite the fact that nearly 20% of the population had a history of opioid misuse, only 1 patient was terminated from the clinic because of repeated episodes of polysubstance use disorder.

GeriPACT has the capability to be responsive to the changing needs of older chronic pain patients as a learning health system using continuous process improvement with frequent team meetings and interdisciplinary care.¹⁵ Our experience with chronic pain management demonstrates the feasibility and quality of guideline-based management and enhances our understanding of the intersection of care, chronic pain management, and opioid use disorder in older adults.

Limitations

Our experience with this population of older veterans may not be applicable to other geriatric populations. While all patients received their primary care at VA and patients were seen regularly, our data may not account for possible use of some community services, including hospitalization and long-term care.

Conclusions

Guideline-based patient-centered medical home management of patients with chronic pain treated with opioids can be an effective model to maintain and improve measures of health and well-being in older patients. Primary care management is critical in optimizing the prescribing and use of opioids in older adults. These complex older patients are best managed by an interdisciplinary team.

Acknowledgments

This work was supported in part by the Geriatric Workforce Enhancement Program, HRSA Grant: 1-U1Q-HP 033085-01-00.

The United States continues to confront an opioid crisis that also affects older adults. According to the Substance Abuse and Mental Health Services Administration from 1999 to 2010, there has been a 4-fold increase in opioid overdose deaths.¹ Between 2010 and 2015, the rate of opioid-related inpatient stays and emergency department (ED) visits for people aged ≥ 65 years increased by 34% and 74%, respectively, and opioid-related overdose deaths continue to increase among older patients.^1,2

Background

Chronic pain is estimated to affect 50 million US adults.³ Individuals receiving long-term opioid therapy may not have experienced relief with other medications or cannot take them for medical safety reasons. Losing access to opioid prescriptions can contribute to misuse of illicit opioids. Implementing best practices for prescription opioid management in older adults is challenging. Older adults have a high prevalence of chronic pain, which is linked to disability and loss of function, reduced mobility, falls, depression, anxiety, sleep disorders, social isolation, and suicide or suicidal ideation.⁴ Until recently, chronic pain in older adults was often treated primarily with long-term opioid prescriptions, despite little evidence for the effectiveness of that treatment for chronic conditions. The prevalence of long-term opioid use in adults has increased from 1.8% (1999-2000) to 5.4% (2013-2014), and 25% of adult long-term opioid users are aged ≥ 65 years.⁵

Older adults are especially vulnerable to developing adverse events (AEs) from opioid use, including constipation, confusion, nausea, falls, and overdose. These factors make safe prescribing more challenging even when opioids are an appropriate therapeutic choice. Older adults often have multiple chronic conditions and take multiple medications that increase risk of AEs due to drug-disease and drug-drug interactions. Finding appropriate alternatives for pain management can be challenging in the presence of dementia if other pharmacologic options are contraindicated or mobility issues limit access to other therapeutic options.

Pain treatment plans should be based on realistic functional goals using a shared decision-making approach accounting for patient and provider expectations. All reasonable nondrug and nonopioid treatments should be considered before opioids are initiated. A comprehensive, person-centered, approach to pain management in older adults that includes opioids, other medications, and complementary and integrative care could improve both pain control and function,and reduce the harms of unnecessary opioid exposure.⁶ A validated risk review should be performed and documented on all patients starting opioids except patients enrolled in hospice care.

In 2018, the US Department of Veterans Affairs (VA) required all facilities to complete case reviews for veterans identified in the Stratification Tool for Opioid Risk Mitigation (STORM) dashboard as being at particularly high risk for AEs among patients prescribed opioids.⁷ We present our experience with a 1-year management of 48 high-risk older patients receiving chronic prescription opioid therapy. These patients obtained all their care at the VA with complete record documentation.

Methods

The Tennessee Valley Healthcare System (TVHS) is an integrated VA health care system with > 100,000 veteran patients in middle Tennessee with 2 medical centers 40 miles apart, and 12 community-based outpatient clinics. In 2011, TVHS developed a geriatric patient-centered medical home model for geriatric primary care—the geriatric patient aligned care team (GeriPACT).⁸ GeriPACT consists of a GeriPACT primary care provider (geriatrician or geriatric nurse practitioner with a panel of about 800 outpatients), social worker, clinical pharmacist, registered nurse care manager, licensed vocational nurse, and clerical staff. GeriPACT is a special population PACT within primary care for complex geriatric and other high-risk vulnerable veterans providing integrated, interdisciplinary assessment and longitudinal management, and coordination of both VA and non-VA-funded (eg, Medicare and Medicaid) services for patients and caregivers. GeriPACT at the Nashville TVHS campus has an enrollment of 745 patients of whom 48 receive chronic prescription opioid therapy. The practice is supported by the VA Computerized Patients Record System (CPRS), including the electronic patient portal, My healtheVet, with telemedicine capabilities. Data were collected by chart review with operations data extracted from the Veterans Health Information System and Technology Architecture.

Best practices for prescription opioids for chronic pain follow the US Department of Health and Human Services Interagency Task Force pain management recommendations.⁴ These include: (1) Effective pain evaluation and management, including diagnostic evaluation and indicated referrals; (2) appropriately prescribed opioids when indicated; and (3) active management of opioid users to prevent AEs and misuse. Strategies used in GeriPACT were adopted from the pain management task force and designed to address needs and challenges associated with responsible chronic opioid prescribing (Table 1).

Results

Chronic opioid patients comprised 6.4% of the GeriPACT population. These patients had many comorbidities, including diabetes mellitus (35%), pulmonary disease (25%), congestive heart failure (18.8%), and dementia (8%). There were 54% with estimated glomerular filtration rates (eGFR) < 60 mL/min, indicating at least stage 3 chronic kidney disease (Table 2). Patients had an average RIOSORD Score of 21 and a 14% risk of opioid induced respiratory depression, and 20% received mental health services.

The mean CAN score was 83.1, suggesting a 1-year risk of 20% for a major AE and 5% mortality risk. Many patients with chronic opioid use were transferred to GeriPACT from primary care due to presence of complex medical issues in addition to need for chronic pain management. In this population, 8% were coprescribed benzodiazepines and opioids. Consults were obtained from interventional pain for 37.5% of patients and palliative care for 27% of patients, the majority for goals of care related to chronic illness and advance directive discussions, and in 1 patient for pain and symptom management. The majority of patients (81%) had advance care planning documents or discussions documented in the electronic health record, and 87.5% of patients received home and community-based support in addition to GeriPACT care.

Medication Reduction

Pharmacists routinely counseled patients regarding the appropriate timing of refills and made monthly calls to request refills of controlled drugs. Three patients agreed to opioid dose reduction due to improved clinical status. Two patients had 25% and 30% dose reductions, respectively, and 1 patient was able to be discontinue opioids. This was achieved through reduction of therapy and or substitution of alternative nonopioid pain medications. One patient was initiated on a slow benzodiazepine taper schedule after decades of benzodiazepine use in addition to engagement with a whole health coach and primary care mental health integration provider. Another patient was disenrolled from the clinic because of repeated nonadherence and positive UDSs for polysubstance use disorder.

Accidental Overdoses

There were 2 patients with accidental overdoses who survived, both on high morphine equivalent daily doses (MEDDs). One patient was admitted to the intensive care unit for increasing confusion after taking more than the prescribed opioids (120 mg MEDD) due to uncontrolled pain for 2 months following surgery. The second patient was taking 66 mg MEDD with multiple risk factors for respiratory depression (severe chronic obstructive pulmonary disease requiring oxygen, obstructive sleep apnea, and concomitant benzodiazepine use) who repeatedly refused tapering of opioids and benzodiazepines. He was found unresponsive in respiratory depression by home health staff. Both patients had naloxone kits in their home that were not administered.

Urine Drug Screening

There was an occasional negative opioid UDS attributed to patients on a low-dose opioid administered more than 24 hours before. Five patients (10.4%) had positive UDSs. Two patients were positive for cocaine, and because of chronic persistent pain and complex medical problems cared for in the clinic, counseled and continued on therapy with no repeat infractions. Two patients were positive for cannabinoids attributed to CBD oil products, which are legal in Tennessee. One patient had repeated positive UDSs for polysubstance abuse and was terminated from the clinic, preferring to use cannabinoids and other substances illegally. Meperidine, fentanyl, tramadol, and other synthetic opioids are not detected on a routine UDS.

Discussion

Primary care is critical in optimizing the prescribing and use of opioids in older adults. The patient-centered medical home can give health care providers the tools and support to provide evidence—based pain management for their older adult patients and to facilitate prescription and monitoring of appropriate opioid use to minimizing AEs and OUD risk. This includes a reliable health information technology monitoring system as part of a collaborative, person-centered care practice capable of managing frail older patients with multiple chronic conditions as well as social risk factors. GeriPACT was able to implement guideline—based evaluation and treatment of chronic pain patients through optimal management of opioids, risk reduction, and monitoring and management of AEs, misuse, and dose tapering using shared decision-making strategies when appropriate.

Complex older patients on chronic opioid treatment can do well and are best managed by an interdisciplinary team. Our panel had a high prevalence of chronic opioid patients and a high expected mortality based on the severity of comorbidities. Patients had frequent access to care with utilization of many support services. Patients received care for many chronic illnesses at the same time they received opioid therapy and generally were satisfied and adherent to their treatment plan. Published reports of the prevalence of coprescribing of benzodiazepines and opioids of 1.1 to 2.7% in the general population, may be lower than our veteran population.¹⁴ Despite the fact that nearly 20% of the population had a history of opioid misuse, only 1 patient was terminated from the clinic because of repeated episodes of polysubstance use disorder.

GeriPACT has the capability to be responsive to the changing needs of older chronic pain patients as a learning health system using continuous process improvement with frequent team meetings and interdisciplinary care.¹⁵ Our experience with chronic pain management demonstrates the feasibility and quality of guideline-based management and enhances our understanding of the intersection of care, chronic pain management, and opioid use disorder in older adults.

Limitations

Our experience with this population of older veterans may not be applicable to other geriatric populations. While all patients received their primary care at VA and patients were seen regularly, our data may not account for possible use of some community services, including hospitalization and long-term care.

Conclusions

Guideline-based patient-centered medical home management of patients with chronic pain treated with opioids can be an effective model to maintain and improve measures of health and well-being in older patients. Primary care management is critical in optimizing the prescribing and use of opioids in older adults. These complex older patients are best managed by an interdisciplinary team.

Acknowledgments

This work was supported in part by the Geriatric Workforce Enhancement Program, HRSA Grant: 1-U1Q-HP 033085-01-00.

Parkinson disease (PD) is the second most common neurodegenerative disorder after Alzheimer disease.¹ Age-standardized incidence rates of PD in population-based studies in Europe and the United States range from 8.6 to 19.0 per 100,000 individuals, using a strict diagnostic criterion for PD.² The negative impact of PD on health-related quality of life imposes a heavy burden on veterans. According to the US Department of Veterans Affairs (VA) National Parkinson’s Disease Consortium, the VA has as many as 50,000 patients with PD under its care. Because of this demand, the VA has strived to revolutionize available services for veterans with PD and related movement disorders.³

The classic motor symptoms of resting tremors, bradykinesia, postural instability, and rigidity of this progressive neurodegenerative disorder is a significant cause of functional limitations that lead to increased falls and inability to perform activities of daily living that challenges the individual and caregiver. ⁴ Rehabilitation has been considered as an adjuvant to surgical and medical treatments for PD to maximize function and minimize complications. High-intensity multimodal exercise boot camps and therapy that focuses on intensely exercising high-amplitude movements, have been shown to improve motor performance in PD.^5,6 Available evidence has shown that exercise-dependent plasticity is the main mechanism underlying the effects of physiotherapy because it increases synaptic strength and affects neurotransmission.⁷ Although there is no consensus on the optimal approach for rehabilitation, innovative techniques have been proposed and studied. One such approach involves virtual reality (VR), which has begun to attract attention for its potential use during rehabilitation.⁸

VR is a simulated experience created by computer-based technology that grants users access to a virtual environment. There are 2 categories of VR: immersive and nonimmersive. Immersive VR is the most direct experience of virtual environments and usually is implemented through a head-mounted display. These displays have monitors in front of each eye, which can provide monocular or biocular imaging with the most common display being small liquid crystal display (LCD) panels.

Nonimmersive VR typically allows a participant to view a virtual environment by using standard high-resolution monitors rather than a headset or an immersive screen room. Many systems are readily available to the general public as electronic interactive entertainment (ie, video games). Interaction with the virtual world happens through interfaces such as keyboards and controllers while viewing a television or computer monitor. These systems often are more accessible and affordable when compared with immersive VR, although this is changing rapidly.

VR therapy is a noninvasive therapeutic alternative modality for PD. This review aims to study the use of VR to treat PD from a rehabilitative standpoint. Although not the only review on the topic, this systematic review is the first to examine the differences between immersive and nonimmersive VR rehabilitation for PD. VR technology is evolving rapidly and the research behind its clinical applications is steadily growing, especially as accessibility improves. This review also is an updated summary of the current literature on the effectiveness of VR therapy during PD rehabilitation.

Methods

Starting in July 2019, the authors searched several databases (PubMed, Google Scholar, Cochrane, and the Physiotherapy Evidence Database [PEDro]) for articles by using the keyword “Parkinson’s disease” combined with either “virtual reality” or “video games.” To find studies specific to rehabilitation, searches included the additional keyword: “rehabilitation.” After compiling an initial set of 89 articles, titles were reviewed to eliminate duplicates. The authors then read the abstracts to exclude study protocols, systematic reviews, and studies that used VR but did not focus on PD or any therapeutic outcome.

Articles were sorted into immersive or nonimmersive virtual reality categories. To be included as immersive VR, studies had to use any type of VR headset or full-scale VR room. Anything less immersive or similar to a traditional video game was included in the nonimmersive VR category. Articles that met inclusion criteria were selected for the systematic review. Criteria for inclusion in this review were: (1) English language; (2) included a study population focused on PD; (3) used some form of VR therapy; and (4) assessed potential rehabilitation by quantitative outcome measures. Only articles published in peer-reviewed journals were included.

Data were extracted into 2 tables specifically modified for this review: immersive and nonimmersive VR. Extracted data included study author name and publication date, study design, methodologic quality, sample size and group allocation, symptom progression via the Hoehn and Yahr Scale (1 to 5), VR modality, presence of control groups, primary outcomes, and primary findings.

Results

This review is reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA).¹⁰ After screening and assessment, 28 articles met inclusion criteria for this review: 7 using immersive VR and 21 using nonimmersive VR (Figure). The immersive studies included 2 RCTs (both with PEDro scores of 5), 1 controlled study with a PEDro score of 5, 1 pre-post pilot study, and 3 cohort studies (Table 2). The nonimmersive studies included 13 RCTs with an average PEDro score of 5.8; 2 pre-post pilot studies, 1 repeated measures study with a historic control, 1 non-RCT, 2 pre-post prospective studies, and 2 cohort studies (1 retrospective and 1 prospective) (Table 3).

Several outcome and assessment tools were used; the most common measures were related to gait, balance, kinematics, and VR feasibility. Studies varied in VR modalities and protocol, ranging from 21 sessions of Nintendo Wii Fit gaming for 7 weeks to 1 session of VR headset use.

Immersive VR

There were fewer immersive VR studies and these studies had lower mean PEDro scores when compared with nonimmersive VR studies. The VR modalities in the immersive studies used a VR headset or a multisensory immersive system that included polarized glasses. All the studies showed positive improvement in primary outcomes with the exception of Ma and colleagues,which showed no difference in success rates or kinematics with moving balls, and only showed improvement in reaching for stationary balls.¹¹ The mean number of participants in the studies was 18.4.

All 7 studies had each participant complete tasks without VR then with the VR therapy. None of the studies compared immersive VR therapy with more conventional therapies. Robles-Garcia and colleagues compared 2 VR groups where the experimental group imitated an avatar’s finger tapping in the VR system while the control group lacked this imitation.¹² The authors found that adding that imitation to the VR group lead to an increase in movement amplitude.

Among the immersive VR studies, only Janeh and colleagues commented on possible adverse effects (AEs) and found that VR was a safe method without AEs of discomfort or simulator sickness.¹³ The other 6 studies did not make any mention or discussion of AEs related to the training.

Nonimmersive VR

VR modalities used in nonimmersive studies included consumer video gaming systems. Nintendo Wii and Microsoft Xbox Kinect were most commonly used. Among the 21 studies, 14 compared VR therapy with a type of traditional exercise (eg, treadmill training, stretching exercises, balance training). The mean number of participants of the studies was 28.3.

Five studies showed a difference between the VR and traditional training groups.^14-18 However, 9 studies showed positive improvement in both groups and found no between-group differences.^19-25 Among the remaining 7 studies, all showed improvement in primary outcomes after adding VR interventional therapy. In 1 RCT, 3 groups were compared (no intervention, Nintendo Wii, and Xbox Kinect) for gait tests, anxiety levels, memory, and attention.²⁶ The authors found that only the Nintendo Wii group showed improvement in outcomes. A prospective cohort study was the only one to compare different doses of VR therapy (10 sessions vs 15 sessions of Nintendo Wii Fit).²⁷ The authors found that both groups demonstrated the same amount of improvement on balance performances with no group effect.

Ten studiesreported no AEs during the training, but also did not define what was considered an AE.^{15,16,19,22-25,27-29} Eight studies did not make any mention of AEs.^{14,17,21,26,27,30-32} Yen and colleagues reported no AEs during training except for the patients’ tendency to fall.²⁰ However, therapists supervised the patients to avoid falls and no falls occurred. Nuic and colleaguesreported 3 serious AEs, unrelated to the training: severe pneumonia (n = 1) and deep-brain stimulation generator replacement (n = 2).³³ During the video game training sessions no specific AEs occurred. Only Pompeu and colleagues defined an AE as any untoward medical occurrence such as convulsion, syncope, dizziness, vertigo, falls, or any medical condition that required hospitalization or disability.³⁴ One researcher registered the occurrence of any AE; however, none occurred during the study period.

Discussion

This systematic review demonstrates that VR therapy is a promising addition to rehabilitation for PD. Evidence supporting VR therapy is limited, but is continually expanding, and current evidence has shown improvement in assessments and rehabilitative outcomes involving PD. Most nonimmersive studies have shown that VR therapy does not lead to better outcomes when compared with traditional therapy but also is not harmful and does provide similar improvement. Immersive VR studies, on the other hand, have not compared therapy with conventional training extensively, and tend to focus more on time for task completion or movement.

There were fewer immersive VR studies than nonimmersive VR studies. This could be because of the increased technological difficulty and demand to correctly execute immersive VR modalities, as well as the—until recently—substantial expense. This might be another reason why the mean PEDro scores for immersive VR RCTs were lower than the mean scores found in nonimmersive RCTs.

Limitations

This review was limited by several factors related to the included studies. A variety of rating scales were used in the immersive and nonimmersive VR studies. Although there was some general overlap with common measurements such as gait, balance, kinematics, and VR feasibility, no studies had the same primary and secondary outcomes. Such heterogeneity in protocols and outcomes limited our ability to draw conclusions from these differing studies. Additionally, the average number of participants of both immersive and nonimmersive studies were small and the statistical significance of findings should be interpreted with caution. Finally, VR devices and systems differed between studies, further limiting comparisons. Although these factors limit this systematic review, we can still identify treatment and research implications. Adequately powered future studies with standardized protocols would further improve the available evidence and support for VR as an intervention.

Conclusions

VR therapy is a promising rehabilitation modality for PD. Additional investigations of VR therapy and PD should include direct comparisons between immersive and nonimmersive VR therapies. It could be hypothesized that the greater immersion and engagement potential of immersive VR would demonstrate greater functional improvement compared with nonimmersive VR, but there is no data to support this for PD. VR therapy for PD appears to be a relatively safe alternative or adjunct to traditional therapy with a potentially positive impact on a variety of symptoms and is growing as an innovative therapeutic approach for PD patients.

Parkinson disease (PD) is the second most common neurodegenerative disorder after Alzheimer disease.¹ Age-standardized incidence rates of PD in population-based studies in Europe and the United States range from 8.6 to 19.0 per 100,000 individuals, using a strict diagnostic criterion for PD.² The negative impact of PD on health-related quality of life imposes a heavy burden on veterans. According to the US Department of Veterans Affairs (VA) National Parkinson’s Disease Consortium, the VA has as many as 50,000 patients with PD under its care. Because of this demand, the VA has strived to revolutionize available services for veterans with PD and related movement disorders.³

The classic motor symptoms of resting tremors, bradykinesia, postural instability, and rigidity of this progressive neurodegenerative disorder is a significant cause of functional limitations that lead to increased falls and inability to perform activities of daily living that challenges the individual and caregiver. ⁴ Rehabilitation has been considered as an adjuvant to surgical and medical treatments for PD to maximize function and minimize complications. High-intensity multimodal exercise boot camps and therapy that focuses on intensely exercising high-amplitude movements, have been shown to improve motor performance in PD.^5,6 Available evidence has shown that exercise-dependent plasticity is the main mechanism underlying the effects of physiotherapy because it increases synaptic strength and affects neurotransmission.⁷ Although there is no consensus on the optimal approach for rehabilitation, innovative techniques have been proposed and studied. One such approach involves virtual reality (VR), which has begun to attract attention for its potential use during rehabilitation.⁸

VR is a simulated experience created by computer-based technology that grants users access to a virtual environment. There are 2 categories of VR: immersive and nonimmersive. Immersive VR is the most direct experience of virtual environments and usually is implemented through a head-mounted display. These displays have monitors in front of each eye, which can provide monocular or biocular imaging with the most common display being small liquid crystal display (LCD) panels.

Nonimmersive VR typically allows a participant to view a virtual environment by using standard high-resolution monitors rather than a headset or an immersive screen room. Many systems are readily available to the general public as electronic interactive entertainment (ie, video games). Interaction with the virtual world happens through interfaces such as keyboards and controllers while viewing a television or computer monitor. These systems often are more accessible and affordable when compared with immersive VR, although this is changing rapidly.

VR therapy is a noninvasive therapeutic alternative modality for PD. This review aims to study the use of VR to treat PD from a rehabilitative standpoint. Although not the only review on the topic, this systematic review is the first to examine the differences between immersive and nonimmersive VR rehabilitation for PD. VR technology is evolving rapidly and the research behind its clinical applications is steadily growing, especially as accessibility improves. This review also is an updated summary of the current literature on the effectiveness of VR therapy during PD rehabilitation.

Methods

Starting in July 2019, the authors searched several databases (PubMed, Google Scholar, Cochrane, and the Physiotherapy Evidence Database [PEDro]) for articles by using the keyword “Parkinson’s disease” combined with either “virtual reality” or “video games.” To find studies specific to rehabilitation, searches included the additional keyword: “rehabilitation.” After compiling an initial set of 89 articles, titles were reviewed to eliminate duplicates. The authors then read the abstracts to exclude study protocols, systematic reviews, and studies that used VR but did not focus on PD or any therapeutic outcome.

Articles were sorted into immersive or nonimmersive virtual reality categories. To be included as immersive VR, studies had to use any type of VR headset or full-scale VR room. Anything less immersive or similar to a traditional video game was included in the nonimmersive VR category. Articles that met inclusion criteria were selected for the systematic review. Criteria for inclusion in this review were: (1) English language; (2) included a study population focused on PD; (3) used some form of VR therapy; and (4) assessed potential rehabilitation by quantitative outcome measures. Only articles published in peer-reviewed journals were included.

Data were extracted into 2 tables specifically modified for this review: immersive and nonimmersive VR. Extracted data included study author name and publication date, study design, methodologic quality, sample size and group allocation, symptom progression via the Hoehn and Yahr Scale (1 to 5), VR modality, presence of control groups, primary outcomes, and primary findings.

Results

This review is reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA).¹⁰ After screening and assessment, 28 articles met inclusion criteria for this review: 7 using immersive VR and 21 using nonimmersive VR (Figure). The immersive studies included 2 RCTs (both with PEDro scores of 5), 1 controlled study with a PEDro score of 5, 1 pre-post pilot study, and 3 cohort studies (Table 2). The nonimmersive studies included 13 RCTs with an average PEDro score of 5.8; 2 pre-post pilot studies, 1 repeated measures study with a historic control, 1 non-RCT, 2 pre-post prospective studies, and 2 cohort studies (1 retrospective and 1 prospective) (Table 3).

Several outcome and assessment tools were used; the most common measures were related to gait, balance, kinematics, and VR feasibility. Studies varied in VR modalities and protocol, ranging from 21 sessions of Nintendo Wii Fit gaming for 7 weeks to 1 session of VR headset use.

Immersive VR

There were fewer immersive VR studies and these studies had lower mean PEDro scores when compared with nonimmersive VR studies. The VR modalities in the immersive studies used a VR headset or a multisensory immersive system that included polarized glasses. All the studies showed positive improvement in primary outcomes with the exception of Ma and colleagues,which showed no difference in success rates or kinematics with moving balls, and only showed improvement in reaching for stationary balls.¹¹ The mean number of participants in the studies was 18.4.

All 7 studies had each participant complete tasks without VR then with the VR therapy. None of the studies compared immersive VR therapy with more conventional therapies. Robles-Garcia and colleagues compared 2 VR groups where the experimental group imitated an avatar’s finger tapping in the VR system while the control group lacked this imitation.¹² The authors found that adding that imitation to the VR group lead to an increase in movement amplitude.

Among the immersive VR studies, only Janeh and colleagues commented on possible adverse effects (AEs) and found that VR was a safe method without AEs of discomfort or simulator sickness.¹³ The other 6 studies did not make any mention or discussion of AEs related to the training.

Nonimmersive VR

VR modalities used in nonimmersive studies included consumer video gaming systems. Nintendo Wii and Microsoft Xbox Kinect were most commonly used. Among the 21 studies, 14 compared VR therapy with a type of traditional exercise (eg, treadmill training, stretching exercises, balance training). The mean number of participants of the studies was 28.3.

Five studies showed a difference between the VR and traditional training groups.^14-18 However, 9 studies showed positive improvement in both groups and found no between-group differences.^19-25 Among the remaining 7 studies, all showed improvement in primary outcomes after adding VR interventional therapy. In 1 RCT, 3 groups were compared (no intervention, Nintendo Wii, and Xbox Kinect) for gait tests, anxiety levels, memory, and attention.²⁶ The authors found that only the Nintendo Wii group showed improvement in outcomes. A prospective cohort study was the only one to compare different doses of VR therapy (10 sessions vs 15 sessions of Nintendo Wii Fit).²⁷ The authors found that both groups demonstrated the same amount of improvement on balance performances with no group effect.

Ten studiesreported no AEs during the training, but also did not define what was considered an AE.^{15,16,19,22-25,27-29} Eight studies did not make any mention of AEs.^{14,17,21,26,27,30-32} Yen and colleagues reported no AEs during training except for the patients’ tendency to fall.²⁰ However, therapists supervised the patients to avoid falls and no falls occurred. Nuic and colleaguesreported 3 serious AEs, unrelated to the training: severe pneumonia (n = 1) and deep-brain stimulation generator replacement (n = 2).³³ During the video game training sessions no specific AEs occurred. Only Pompeu and colleagues defined an AE as any untoward medical occurrence such as convulsion, syncope, dizziness, vertigo, falls, or any medical condition that required hospitalization or disability.³⁴ One researcher registered the occurrence of any AE; however, none occurred during the study period.

Discussion

This systematic review demonstrates that VR therapy is a promising addition to rehabilitation for PD. Evidence supporting VR therapy is limited, but is continually expanding, and current evidence has shown improvement in assessments and rehabilitative outcomes involving PD. Most nonimmersive studies have shown that VR therapy does not lead to better outcomes when compared with traditional therapy but also is not harmful and does provide similar improvement. Immersive VR studies, on the other hand, have not compared therapy with conventional training extensively, and tend to focus more on time for task completion or movement.

There were fewer immersive VR studies than nonimmersive VR studies. This could be because of the increased technological difficulty and demand to correctly execute immersive VR modalities, as well as the—until recently—substantial expense. This might be another reason why the mean PEDro scores for immersive VR RCTs were lower than the mean scores found in nonimmersive RCTs.

Limitations

This review was limited by several factors related to the included studies. A variety of rating scales were used in the immersive and nonimmersive VR studies. Although there was some general overlap with common measurements such as gait, balance, kinematics, and VR feasibility, no studies had the same primary and secondary outcomes. Such heterogeneity in protocols and outcomes limited our ability to draw conclusions from these differing studies. Additionally, the average number of participants of both immersive and nonimmersive studies were small and the statistical significance of findings should be interpreted with caution. Finally, VR devices and systems differed between studies, further limiting comparisons. Although these factors limit this systematic review, we can still identify treatment and research implications. Adequately powered future studies with standardized protocols would further improve the available evidence and support for VR as an intervention.

Conclusions

VR therapy is a promising rehabilitation modality for PD. Additional investigations of VR therapy and PD should include direct comparisons between immersive and nonimmersive VR therapies. It could be hypothesized that the greater immersion and engagement potential of immersive VR would demonstrate greater functional improvement compared with nonimmersive VR, but there is no data to support this for PD. VR therapy for PD appears to be a relatively safe alternative or adjunct to traditional therapy with a potentially positive impact on a variety of symptoms and is growing as an innovative therapeutic approach for PD patients.

Parkinson disease (PD) is the second most common neurodegenerative disorder after Alzheimer disease.¹ Age-standardized incidence rates of PD in population-based studies in Europe and the United States range from 8.6 to 19.0 per 100,000 individuals, using a strict diagnostic criterion for PD.² The negative impact of PD on health-related quality of life imposes a heavy burden on veterans. According to the US Department of Veterans Affairs (VA) National Parkinson’s Disease Consortium, the VA has as many as 50,000 patients with PD under its care. Because of this demand, the VA has strived to revolutionize available services for veterans with PD and related movement disorders.³

The classic motor symptoms of resting tremors, bradykinesia, postural instability, and rigidity of this progressive neurodegenerative disorder is a significant cause of functional limitations that lead to increased falls and inability to perform activities of daily living that challenges the individual and caregiver. ⁴ Rehabilitation has been considered as an adjuvant to surgical and medical treatments for PD to maximize function and minimize complications. High-intensity multimodal exercise boot camps and therapy that focuses on intensely exercising high-amplitude movements, have been shown to improve motor performance in PD.^5,6 Available evidence has shown that exercise-dependent plasticity is the main mechanism underlying the effects of physiotherapy because it increases synaptic strength and affects neurotransmission.⁷ Although there is no consensus on the optimal approach for rehabilitation, innovative techniques have been proposed and studied. One such approach involves virtual reality (VR), which has begun to attract attention for its potential use during rehabilitation.⁸

VR is a simulated experience created by computer-based technology that grants users access to a virtual environment. There are 2 categories of VR: immersive and nonimmersive. Immersive VR is the most direct experience of virtual environments and usually is implemented through a head-mounted display. These displays have monitors in front of each eye, which can provide monocular or biocular imaging with the most common display being small liquid crystal display (LCD) panels.

Nonimmersive VR typically allows a participant to view a virtual environment by using standard high-resolution monitors rather than a headset or an immersive screen room. Many systems are readily available to the general public as electronic interactive entertainment (ie, video games). Interaction with the virtual world happens through interfaces such as keyboards and controllers while viewing a television or computer monitor. These systems often are more accessible and affordable when compared with immersive VR, although this is changing rapidly.

VR therapy is a noninvasive therapeutic alternative modality for PD. This review aims to study the use of VR to treat PD from a rehabilitative standpoint. Although not the only review on the topic, this systematic review is the first to examine the differences between immersive and nonimmersive VR rehabilitation for PD. VR technology is evolving rapidly and the research behind its clinical applications is steadily growing, especially as accessibility improves. This review also is an updated summary of the current literature on the effectiveness of VR therapy during PD rehabilitation.

Methods

Starting in July 2019, the authors searched several databases (PubMed, Google Scholar, Cochrane, and the Physiotherapy Evidence Database [PEDro]) for articles by using the keyword “Parkinson’s disease” combined with either “virtual reality” or “video games.” To find studies specific to rehabilitation, searches included the additional keyword: “rehabilitation.” After compiling an initial set of 89 articles, titles were reviewed to eliminate duplicates. The authors then read the abstracts to exclude study protocols, systematic reviews, and studies that used VR but did not focus on PD or any therapeutic outcome.

Articles were sorted into immersive or nonimmersive virtual reality categories. To be included as immersive VR, studies had to use any type of VR headset or full-scale VR room. Anything less immersive or similar to a traditional video game was included in the nonimmersive VR category. Articles that met inclusion criteria were selected for the systematic review. Criteria for inclusion in this review were: (1) English language; (2) included a study population focused on PD; (3) used some form of VR therapy; and (4) assessed potential rehabilitation by quantitative outcome measures. Only articles published in peer-reviewed journals were included.

Data were extracted into 2 tables specifically modified for this review: immersive and nonimmersive VR. Extracted data included study author name and publication date, study design, methodologic quality, sample size and group allocation, symptom progression via the Hoehn and Yahr Scale (1 to 5), VR modality, presence of control groups, primary outcomes, and primary findings.

Results

This review is reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA).¹⁰ After screening and assessment, 28 articles met inclusion criteria for this review: 7 using immersive VR and 21 using nonimmersive VR (Figure). The immersive studies included 2 RCTs (both with PEDro scores of 5), 1 controlled study with a PEDro score of 5, 1 pre-post pilot study, and 3 cohort studies (Table 2). The nonimmersive studies included 13 RCTs with an average PEDro score of 5.8; 2 pre-post pilot studies, 1 repeated measures study with a historic control, 1 non-RCT, 2 pre-post prospective studies, and 2 cohort studies (1 retrospective and 1 prospective) (Table 3).

Several outcome and assessment tools were used; the most common measures were related to gait, balance, kinematics, and VR feasibility. Studies varied in VR modalities and protocol, ranging from 21 sessions of Nintendo Wii Fit gaming for 7 weeks to 1 session of VR headset use.

Immersive VR

There were fewer immersive VR studies and these studies had lower mean PEDro scores when compared with nonimmersive VR studies. The VR modalities in the immersive studies used a VR headset or a multisensory immersive system that included polarized glasses. All the studies showed positive improvement in primary outcomes with the exception of Ma and colleagues,which showed no difference in success rates or kinematics with moving balls, and only showed improvement in reaching for stationary balls.¹¹ The mean number of participants in the studies was 18.4.

All 7 studies had each participant complete tasks without VR then with the VR therapy. None of the studies compared immersive VR therapy with more conventional therapies. Robles-Garcia and colleagues compared 2 VR groups where the experimental group imitated an avatar’s finger tapping in the VR system while the control group lacked this imitation.¹² The authors found that adding that imitation to the VR group lead to an increase in movement amplitude.

Among the immersive VR studies, only Janeh and colleagues commented on possible adverse effects (AEs) and found that VR was a safe method without AEs of discomfort or simulator sickness.¹³ The other 6 studies did not make any mention or discussion of AEs related to the training.

Nonimmersive VR

VR modalities used in nonimmersive studies included consumer video gaming systems. Nintendo Wii and Microsoft Xbox Kinect were most commonly used. Among the 21 studies, 14 compared VR therapy with a type of traditional exercise (eg, treadmill training, stretching exercises, balance training). The mean number of participants of the studies was 28.3.

Five studies showed a difference between the VR and traditional training groups.^14-18 However, 9 studies showed positive improvement in both groups and found no between-group differences.^19-25 Among the remaining 7 studies, all showed improvement in primary outcomes after adding VR interventional therapy. In 1 RCT, 3 groups were compared (no intervention, Nintendo Wii, and Xbox Kinect) for gait tests, anxiety levels, memory, and attention.²⁶ The authors found that only the Nintendo Wii group showed improvement in outcomes. A prospective cohort study was the only one to compare different doses of VR therapy (10 sessions vs 15 sessions of Nintendo Wii Fit).²⁷ The authors found that both groups demonstrated the same amount of improvement on balance performances with no group effect.

Ten studiesreported no AEs during the training, but also did not define what was considered an AE.^{15,16,19,22-25,27-29} Eight studies did not make any mention of AEs.^{14,17,21,26,27,30-32} Yen and colleagues reported no AEs during training except for the patients’ tendency to fall.²⁰ However, therapists supervised the patients to avoid falls and no falls occurred. Nuic and colleaguesreported 3 serious AEs, unrelated to the training: severe pneumonia (n = 1) and deep-brain stimulation generator replacement (n = 2).³³ During the video game training sessions no specific AEs occurred. Only Pompeu and colleagues defined an AE as any untoward medical occurrence such as convulsion, syncope, dizziness, vertigo, falls, or any medical condition that required hospitalization or disability.³⁴ One researcher registered the occurrence of any AE; however, none occurred during the study period.

Discussion

This systematic review demonstrates that VR therapy is a promising addition to rehabilitation for PD. Evidence supporting VR therapy is limited, but is continually expanding, and current evidence has shown improvement in assessments and rehabilitative outcomes involving PD. Most nonimmersive studies have shown that VR therapy does not lead to better outcomes when compared with traditional therapy but also is not harmful and does provide similar improvement. Immersive VR studies, on the other hand, have not compared therapy with conventional training extensively, and tend to focus more on time for task completion or movement.

There were fewer immersive VR studies than nonimmersive VR studies. This could be because of the increased technological difficulty and demand to correctly execute immersive VR modalities, as well as the—until recently—substantial expense. This might be another reason why the mean PEDro scores for immersive VR RCTs were lower than the mean scores found in nonimmersive RCTs.

Limitations

This review was limited by several factors related to the included studies. A variety of rating scales were used in the immersive and nonimmersive VR studies. Although there was some general overlap with common measurements such as gait, balance, kinematics, and VR feasibility, no studies had the same primary and secondary outcomes. Such heterogeneity in protocols and outcomes limited our ability to draw conclusions from these differing studies. Additionally, the average number of participants of both immersive and nonimmersive studies were small and the statistical significance of findings should be interpreted with caution. Finally, VR devices and systems differed between studies, further limiting comparisons. Although these factors limit this systematic review, we can still identify treatment and research implications. Adequately powered future studies with standardized protocols would further improve the available evidence and support for VR as an intervention.

Conclusions

VR therapy is a promising rehabilitation modality for PD. Additional investigations of VR therapy and PD should include direct comparisons between immersive and nonimmersive VR therapies. It could be hypothesized that the greater immersion and engagement potential of immersive VR would demonstrate greater functional improvement compared with nonimmersive VR, but there is no data to support this for PD. VR therapy for PD appears to be a relatively safe alternative or adjunct to traditional therapy with a potentially positive impact on a variety of symptoms and is growing as an innovative therapeutic approach for PD patients.