Thrombus

Image by Andre E.X. Brown

Results of a meta-analysis suggest elastic compression stockings do not significantly reduce the risk of post-thrombotic syndrome (PTS) after deep vein thrombosis (DVT).

Investigators analyzed more than 600 past reports and studies involving elastic compression stockings, including the SOX trial.

And the results showed no significant difference in PTS incidence between patients who wore these stockings and those who did not.

Riyaz Bashir, MD, of Temple University Hospital in Philadelphia, Pennsylvania, and his colleagues performed the analysis and reported the results in The Lancet Haematology.

The investigators analyzed 674 reports, which included 6 randomized trials and a total of 1462 patients. The patients’ mean age was 59.5, and 56% were men.

All of the studies used stockings with a pressure range of 20 mm Hg to 40 mm Hg. Patient compliance varied from 55.6% to 91.6% and often decreased during follow-up. In most of the studies, the control group did not wear stockings, but, in 2 studies, the control group wore placebo stockings.

The data showed that use of elastic compression stockings was not associated with PTS prevention. The incidence of PTS was 36% (269/739) among patients who wore the stockings and 45% (322/723) among controls. The odds ratio (OR) was 0.56 (P=0.12).

The investigators observed similar results in subgroup analyses, when they tried to account for patient heterogeneity (27% vs 37%, OR=0.63, P=0.23) or diagnosis by Villalta scoring (43% vs 45%, OR=0.81, P=0.62) and when they looked at patients randomized within 1 month of DVT diagnosis (41% vs 49%, OR=0.57, P=0.24).

Furthermore, there was no significant difference between the treatment groups with regard to mortality or DVT recurrence.

The mortality incidence was 10% in both groups (OR 0.98, P=0.92), while the incidence of DVT recurrence was 6.4% in the compression stocking group and 6.8% in controls (OR=0.93, P=0.69).

“Many questions remain, such as whether certain groups of patients—like females or elderly patients—benefit from [compression stockings] or whether the timing of the intervention would make a difference,” Dr Bashir said.

“Based on the results of our study, we believe it’s too early to recommend that physicians stop using compression stockings and therefore should not give up on this modality of treatment yet. This study also highlights that there is a real need for new and more effective therapies for the treatment and prevention of post-thrombotic syndrome.”

Thrombus

Image by Andre E.X. Brown

Results of a meta-analysis suggest elastic compression stockings do not significantly reduce the risk of post-thrombotic syndrome (PTS) after deep vein thrombosis (DVT).

Investigators analyzed more than 600 past reports and studies involving elastic compression stockings, including the SOX trial.

And the results showed no significant difference in PTS incidence between patients who wore these stockings and those who did not.

Riyaz Bashir, MD, of Temple University Hospital in Philadelphia, Pennsylvania, and his colleagues performed the analysis and reported the results in The Lancet Haematology.

The investigators analyzed 674 reports, which included 6 randomized trials and a total of 1462 patients. The patients’ mean age was 59.5, and 56% were men.

All of the studies used stockings with a pressure range of 20 mm Hg to 40 mm Hg. Patient compliance varied from 55.6% to 91.6% and often decreased during follow-up. In most of the studies, the control group did not wear stockings, but, in 2 studies, the control group wore placebo stockings.

The data showed that use of elastic compression stockings was not associated with PTS prevention. The incidence of PTS was 36% (269/739) among patients who wore the stockings and 45% (322/723) among controls. The odds ratio (OR) was 0.56 (P=0.12).

The investigators observed similar results in subgroup analyses, when they tried to account for patient heterogeneity (27% vs 37%, OR=0.63, P=0.23) or diagnosis by Villalta scoring (43% vs 45%, OR=0.81, P=0.62) and when they looked at patients randomized within 1 month of DVT diagnosis (41% vs 49%, OR=0.57, P=0.24).

Furthermore, there was no significant difference between the treatment groups with regard to mortality or DVT recurrence.

The mortality incidence was 10% in both groups (OR 0.98, P=0.92), while the incidence of DVT recurrence was 6.4% in the compression stocking group and 6.8% in controls (OR=0.93, P=0.69).

“Many questions remain, such as whether certain groups of patients—like females or elderly patients—benefit from [compression stockings] or whether the timing of the intervention would make a difference,” Dr Bashir said.

“Based on the results of our study, we believe it’s too early to recommend that physicians stop using compression stockings and therefore should not give up on this modality of treatment yet. This study also highlights that there is a real need for new and more effective therapies for the treatment and prevention of post-thrombotic syndrome.”

Thrombus

Image by Andre E.X. Brown

Results of a meta-analysis suggest elastic compression stockings do not significantly reduce the risk of post-thrombotic syndrome (PTS) after deep vein thrombosis (DVT).

Investigators analyzed more than 600 past reports and studies involving elastic compression stockings, including the SOX trial.

And the results showed no significant difference in PTS incidence between patients who wore these stockings and those who did not.

Riyaz Bashir, MD, of Temple University Hospital in Philadelphia, Pennsylvania, and his colleagues performed the analysis and reported the results in The Lancet Haematology.

The investigators analyzed 674 reports, which included 6 randomized trials and a total of 1462 patients. The patients’ mean age was 59.5, and 56% were men.

All of the studies used stockings with a pressure range of 20 mm Hg to 40 mm Hg. Patient compliance varied from 55.6% to 91.6% and often decreased during follow-up. In most of the studies, the control group did not wear stockings, but, in 2 studies, the control group wore placebo stockings.

The data showed that use of elastic compression stockings was not associated with PTS prevention. The incidence of PTS was 36% (269/739) among patients who wore the stockings and 45% (322/723) among controls. The odds ratio (OR) was 0.56 (P=0.12).

The investigators observed similar results in subgroup analyses, when they tried to account for patient heterogeneity (27% vs 37%, OR=0.63, P=0.23) or diagnosis by Villalta scoring (43% vs 45%, OR=0.81, P=0.62) and when they looked at patients randomized within 1 month of DVT diagnosis (41% vs 49%, OR=0.57, P=0.24).

Furthermore, there was no significant difference between the treatment groups with regard to mortality or DVT recurrence.

The mortality incidence was 10% in both groups (OR 0.98, P=0.92), while the incidence of DVT recurrence was 6.4% in the compression stocking group and 6.8% in controls (OR=0.93, P=0.69).

“Many questions remain, such as whether certain groups of patients—like females or elderly patients—benefit from [compression stockings] or whether the timing of the intervention would make a difference,” Dr Bashir said.

“Based on the results of our study, we believe it’s too early to recommend that physicians stop using compression stockings and therefore should not give up on this modality of treatment yet. This study also highlights that there is a real need for new and more effective therapies for the treatment and prevention of post-thrombotic syndrome.”

Doctor evaluating patient

Photo courtesy of the CDC

WASHINGTON, DC—The American Society of Hematology (ASH) has created a toolkit to help hematologists aid patients who are transitioning from pediatric to adult practices.

The toolkit contains general resources for all hematologic conditions, as well as specific resources for patients with hemophilia and sickle cell disease.

It includes 2 types of forms—a transition-readiness assessment and a clinical summary.

The toolkit was presented at the American College of Physicians (ACP) Internal Medicine Meeting 2016.

“Transitioning from pediatric to adult healthcare practices is often a challenge for patients with chronic medical issues because it can be difficult to adhere to a treatment regimen or attend regular appointments without the assistance of a parent or guardian,” said ASH President Charles S. Abrams, MD, of the University of Pennsylvania in Philadelphia.

“ASH recognizes that understanding a patient’s preparedness to take control of his or her medical condition in adulthood can make a huge difference in quality of care, which is why we are pleased to join the American College of Physicians and partner societies in this important initiative.”

ASH joined more than 2 dozen groups to participate in the ACP’s Pediatric to Adult Care Transition Initiative. The goal of this initiative was to develop guidance and tools that both primary care internal medicine and subspecialty practices can use for patients who are transitioning from pediatric/adolescent practices to adult care.

An ASH Transitions Work Group, made up of society members from pediatric and adult practices, developed 3 segments of the hematology-specific toolkit:

• generic forms for patients with any hematologic condition, with an addendum that includes links to additional condition-specific guidelines and resources
• specific forms for hemophilia
• specific forms for sickle cell disease.

For each segment, there are 2 types of forms— a transition-readiness assessment and a clinical summary.

The transition-readiness assessment should be completed by the patient. It assesses the patient’s readiness for the transition to adult care by evaluating the patient’s understanding of his or her condition and ability to manage medications, appointments, insurance, and medical privacy issues.

This assessment should be used by the adult care team to assess any remaining gaps in the patient’s self-care knowledge or additional issues that should be addressed to ensure optimal care.

The clinical summary is a medical record summary to be completed by the referring provider and the patient. The summary contains essential clinical information regarding the patient’s condition that is to be included in the patient’s medical record upon transfer to the adult practice.

More information on the ACP Pediatric to Adult Care Transitions Initiative is available on the ACP website. The forms for the ASH transitions toolkit are available in the “Hematology” section of the Condition-Specific Tools page.

Doctor evaluating patient

Photo courtesy of the CDC

WASHINGTON, DC—The American Society of Hematology (ASH) has created a toolkit to help hematologists aid patients who are transitioning from pediatric to adult practices.

The toolkit contains general resources for all hematologic conditions, as well as specific resources for patients with hemophilia and sickle cell disease.

It includes 2 types of forms—a transition-readiness assessment and a clinical summary.

The toolkit was presented at the American College of Physicians (ACP) Internal Medicine Meeting 2016.

“Transitioning from pediatric to adult healthcare practices is often a challenge for patients with chronic medical issues because it can be difficult to adhere to a treatment regimen or attend regular appointments without the assistance of a parent or guardian,” said ASH President Charles S. Abrams, MD, of the University of Pennsylvania in Philadelphia.

“ASH recognizes that understanding a patient’s preparedness to take control of his or her medical condition in adulthood can make a huge difference in quality of care, which is why we are pleased to join the American College of Physicians and partner societies in this important initiative.”

ASH joined more than 2 dozen groups to participate in the ACP’s Pediatric to Adult Care Transition Initiative. The goal of this initiative was to develop guidance and tools that both primary care internal medicine and subspecialty practices can use for patients who are transitioning from pediatric/adolescent practices to adult care.

An ASH Transitions Work Group, made up of society members from pediatric and adult practices, developed 3 segments of the hematology-specific toolkit:

• generic forms for patients with any hematologic condition, with an addendum that includes links to additional condition-specific guidelines and resources
• specific forms for hemophilia
• specific forms for sickle cell disease.

For each segment, there are 2 types of forms— a transition-readiness assessment and a clinical summary.

The transition-readiness assessment should be completed by the patient. It assesses the patient’s readiness for the transition to adult care by evaluating the patient’s understanding of his or her condition and ability to manage medications, appointments, insurance, and medical privacy issues.

This assessment should be used by the adult care team to assess any remaining gaps in the patient’s self-care knowledge or additional issues that should be addressed to ensure optimal care.

The clinical summary is a medical record summary to be completed by the referring provider and the patient. The summary contains essential clinical information regarding the patient’s condition that is to be included in the patient’s medical record upon transfer to the adult practice.

More information on the ACP Pediatric to Adult Care Transitions Initiative is available on the ACP website. The forms for the ASH transitions toolkit are available in the “Hematology” section of the Condition-Specific Tools page.

Doctor evaluating patient

Photo courtesy of the CDC

WASHINGTON, DC—The American Society of Hematology (ASH) has created a toolkit to help hematologists aid patients who are transitioning from pediatric to adult practices.

The toolkit contains general resources for all hematologic conditions, as well as specific resources for patients with hemophilia and sickle cell disease.

It includes 2 types of forms—a transition-readiness assessment and a clinical summary.

The toolkit was presented at the American College of Physicians (ACP) Internal Medicine Meeting 2016.

“Transitioning from pediatric to adult healthcare practices is often a challenge for patients with chronic medical issues because it can be difficult to adhere to a treatment regimen or attend regular appointments without the assistance of a parent or guardian,” said ASH President Charles S. Abrams, MD, of the University of Pennsylvania in Philadelphia.

“ASH recognizes that understanding a patient’s preparedness to take control of his or her medical condition in adulthood can make a huge difference in quality of care, which is why we are pleased to join the American College of Physicians and partner societies in this important initiative.”

ASH joined more than 2 dozen groups to participate in the ACP’s Pediatric to Adult Care Transition Initiative. The goal of this initiative was to develop guidance and tools that both primary care internal medicine and subspecialty practices can use for patients who are transitioning from pediatric/adolescent practices to adult care.

An ASH Transitions Work Group, made up of society members from pediatric and adult practices, developed 3 segments of the hematology-specific toolkit:

• generic forms for patients with any hematologic condition, with an addendum that includes links to additional condition-specific guidelines and resources
• specific forms for hemophilia
• specific forms for sickle cell disease.

For each segment, there are 2 types of forms— a transition-readiness assessment and a clinical summary.

The transition-readiness assessment should be completed by the patient. It assesses the patient’s readiness for the transition to adult care by evaluating the patient’s understanding of his or her condition and ability to manage medications, appointments, insurance, and medical privacy issues.

This assessment should be used by the adult care team to assess any remaining gaps in the patient’s self-care knowledge or additional issues that should be addressed to ensure optimal care.

The clinical summary is a medical record summary to be completed by the referring provider and the patient. The summary contains essential clinical information regarding the patient’s condition that is to be included in the patient’s medical record upon transfer to the adult practice.

More information on the ACP Pediatric to Adult Care Transitions Initiative is available on the ACP website. The forms for the ASH transitions toolkit are available in the “Hematology” section of the Condition-Specific Tools page.

AMSTERDAM – Neither cycling through a regular schedule of antibiotics on a unit-wide basis, nor randomly mixing them on a patient-level basis reduced the prevalence of antibiotic resistance in eight European intensive care units, a randomized study has determined.

Lead investigator Dr. Pleun Joppe van Duijn of University Medical Center Utrecht (the Netherlands), said he and his colleagues did, however, discover a few common sense findings that seemed to positively affect antibiotic resistance, including compliance with hand hygiene, shorter lengths of stay, staff ratio, and unit occupancy rate. He reported the results of his research at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

Edwin Verin/©Thinkstock

Many ICUs in Europe have one preferred empirical treatment strategy which, Dr. van Duijn said, may create selective pressure for a single resistance type. “An alternative to this is a program of antibiotic rotation,” he noted. “By constantly changing the preferred first-line treatment, selective pressure is constantly changing, which may reduce selection of antibiotic resistance.”

Dr. van Duijn and his colleagues examined this idea in a randomized crossover trial that compared antibiotic cycling and mixing. The protocols employed three antibiotic classes: third- and fourth-generation cephalosporins, piperacillin/tazobactam, and carbapenems. The trial was conducted in eight ICUs in Belgium, Germany, France, Slovenia, and Portugal.

The sites were randomized to two 9-month interventions of cycling or mixing antibiotics, with a 1-month washout period between the two interventions. In cycling protocol, the preferred empiric antibiotic was changed every 6 weeks. In the mixing protocol, every consecutive patient received a different antibiotic. However, treating physicians were allowed to deviate from any protocol for patient safety or to optimize treatment.

The primary endpoint was the monthly prevalence of perineal and/or respiratory carriage of two classes of bacteria:

• Enterobacteriaceae species that were piperacillin/tazobactam–resistant or that showed extended spectrum beta-lactamase production.

• Pseudomonas aeruginosa and Acinetobacter species that were either piperacillin/tazobactam– or carbapenem-resistant.

In all, 8,945 patients were involved, with 4,238 exposed to cycling and 4,707 to mixing. Patients were a mean of 62 years old, with a mean 7-day length of stay. About 4.5% were already colonized with resistant bacteria upon admission. A quarter were on contact isolation; 2% were on both droplet and respiratory isolation.

The overall mortality rate was 11% and did not differ between the cycling and mixing groups (10.9% vs. 11.6%). Antibiotic resistance developed in 22.6% of the cycling group and 21.5% of the mixing group – not a significant difference. Neither protocol significantly reduced over time the amount of antibiotic resistance that was observed in the baseline period.

A multivariate analysis did, however, find a few things associated with resistance prevalence. Women were about 58% less likely to develop a resistant bacterial strain than men. Patients who stayed less than 48 hours had a 38% decreased risk of developing a resistant strain. Good staff compliance with hand hygiene reduced the risk by 12%, and having one-on-one nursing reduced it by 53%.

The study was funded by the European Community’s Seventh Framework Programme. Dr. van Duijn had no financial declarations.

[email protected]

AMSTERDAM – Neither cycling through a regular schedule of antibiotics on a unit-wide basis, nor randomly mixing them on a patient-level basis reduced the prevalence of antibiotic resistance in eight European intensive care units, a randomized study has determined.

Lead investigator Dr. Pleun Joppe van Duijn of University Medical Center Utrecht (the Netherlands), said he and his colleagues did, however, discover a few common sense findings that seemed to positively affect antibiotic resistance, including compliance with hand hygiene, shorter lengths of stay, staff ratio, and unit occupancy rate. He reported the results of his research at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

Edwin Verin/©Thinkstock

Many ICUs in Europe have one preferred empirical treatment strategy which, Dr. van Duijn said, may create selective pressure for a single resistance type. “An alternative to this is a program of antibiotic rotation,” he noted. “By constantly changing the preferred first-line treatment, selective pressure is constantly changing, which may reduce selection of antibiotic resistance.”

Dr. van Duijn and his colleagues examined this idea in a randomized crossover trial that compared antibiotic cycling and mixing. The protocols employed three antibiotic classes: third- and fourth-generation cephalosporins, piperacillin/tazobactam, and carbapenems. The trial was conducted in eight ICUs in Belgium, Germany, France, Slovenia, and Portugal.

The sites were randomized to two 9-month interventions of cycling or mixing antibiotics, with a 1-month washout period between the two interventions. In cycling protocol, the preferred empiric antibiotic was changed every 6 weeks. In the mixing protocol, every consecutive patient received a different antibiotic. However, treating physicians were allowed to deviate from any protocol for patient safety or to optimize treatment.

The primary endpoint was the monthly prevalence of perineal and/or respiratory carriage of two classes of bacteria:

• Enterobacteriaceae species that were piperacillin/tazobactam–resistant or that showed extended spectrum beta-lactamase production.

• Pseudomonas aeruginosa and Acinetobacter species that were either piperacillin/tazobactam– or carbapenem-resistant.

In all, 8,945 patients were involved, with 4,238 exposed to cycling and 4,707 to mixing. Patients were a mean of 62 years old, with a mean 7-day length of stay. About 4.5% were already colonized with resistant bacteria upon admission. A quarter were on contact isolation; 2% were on both droplet and respiratory isolation.

The overall mortality rate was 11% and did not differ between the cycling and mixing groups (10.9% vs. 11.6%). Antibiotic resistance developed in 22.6% of the cycling group and 21.5% of the mixing group – not a significant difference. Neither protocol significantly reduced over time the amount of antibiotic resistance that was observed in the baseline period.

A multivariate analysis did, however, find a few things associated with resistance prevalence. Women were about 58% less likely to develop a resistant bacterial strain than men. Patients who stayed less than 48 hours had a 38% decreased risk of developing a resistant strain. Good staff compliance with hand hygiene reduced the risk by 12%, and having one-on-one nursing reduced it by 53%.

The study was funded by the European Community’s Seventh Framework Programme. Dr. van Duijn had no financial declarations.

[email protected]

AMSTERDAM – Neither cycling through a regular schedule of antibiotics on a unit-wide basis, nor randomly mixing them on a patient-level basis reduced the prevalence of antibiotic resistance in eight European intensive care units, a randomized study has determined.

Lead investigator Dr. Pleun Joppe van Duijn of University Medical Center Utrecht (the Netherlands), said he and his colleagues did, however, discover a few common sense findings that seemed to positively affect antibiotic resistance, including compliance with hand hygiene, shorter lengths of stay, staff ratio, and unit occupancy rate. He reported the results of his research at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

Edwin Verin/©Thinkstock

Many ICUs in Europe have one preferred empirical treatment strategy which, Dr. van Duijn said, may create selective pressure for a single resistance type. “An alternative to this is a program of antibiotic rotation,” he noted. “By constantly changing the preferred first-line treatment, selective pressure is constantly changing, which may reduce selection of antibiotic resistance.”

Dr. van Duijn and his colleagues examined this idea in a randomized crossover trial that compared antibiotic cycling and mixing. The protocols employed three antibiotic classes: third- and fourth-generation cephalosporins, piperacillin/tazobactam, and carbapenems. The trial was conducted in eight ICUs in Belgium, Germany, France, Slovenia, and Portugal.

The sites were randomized to two 9-month interventions of cycling or mixing antibiotics, with a 1-month washout period between the two interventions. In cycling protocol, the preferred empiric antibiotic was changed every 6 weeks. In the mixing protocol, every consecutive patient received a different antibiotic. However, treating physicians were allowed to deviate from any protocol for patient safety or to optimize treatment.

The primary endpoint was the monthly prevalence of perineal and/or respiratory carriage of two classes of bacteria:

• Enterobacteriaceae species that were piperacillin/tazobactam–resistant or that showed extended spectrum beta-lactamase production.

• Pseudomonas aeruginosa and Acinetobacter species that were either piperacillin/tazobactam– or carbapenem-resistant.

In all, 8,945 patients were involved, with 4,238 exposed to cycling and 4,707 to mixing. Patients were a mean of 62 years old, with a mean 7-day length of stay. About 4.5% were already colonized with resistant bacteria upon admission. A quarter were on contact isolation; 2% were on both droplet and respiratory isolation.

The overall mortality rate was 11% and did not differ between the cycling and mixing groups (10.9% vs. 11.6%). Antibiotic resistance developed in 22.6% of the cycling group and 21.5% of the mixing group – not a significant difference. Neither protocol significantly reduced over time the amount of antibiotic resistance that was observed in the baseline period.

A multivariate analysis did, however, find a few things associated with resistance prevalence. Women were about 58% less likely to develop a resistant bacterial strain than men. Patients who stayed less than 48 hours had a 38% decreased risk of developing a resistant strain. Good staff compliance with hand hygiene reduced the risk by 12%, and having one-on-one nursing reduced it by 53%.

The study was funded by the European Community’s Seventh Framework Programme. Dr. van Duijn had no financial declarations.

[email protected]

VANCOUVER—At a rate of 2.5 per 1,000 person-years, epilepsy incidence in adults age 65 and older is common, according to a retrospective analysis of clinical and administrative data. "To put these study results in context, this incidence rate is 1.5 times higher than that of Parkinson's disease," said Hyunmi Choi, MD, MS, of Columbia University, New York City. Most important, she said, is the finding that black older adults have double the incidence rate of their white counterparts, independent of stroke. "These findings underscore the need for further studies that directly examine the mechanisms by which race affects epilepsy risk," said Dr. Choi at the 68th Annual Meeting of the American Academy of Neurology.

Geographic and Cultural Diversity

Dr. Choi and colleagues from Columbia University and the University of Washington in Seattle, examined data from the Cardiovascular Health Study (CHS), a prospective cohort study of coronary heart disease and stroke. CHS began in 1989 and enrolled 5,201 adults age 65 and older from multiple regions of the country: Sacramento county, California; Washington county, Maryland; Forsyth county, North Carolina; and Pittsburgh, Pennsylvania. A second cohort of 687 predominantly African American participants was enrolled in 1992. In-person evaluations were conducted at baseline, followed by annual in-person evaluations interspersed with phone calls every six months. "Recently, CHS merged its data with those of the Centers for Medicare and Medicaid Services (CMS)," Dr. Choi said.

The researchers used multiple data sources to identify potential epilepsy cases, including self report, information on antiepileptic medication, hospitalization discharge claims data, and outpatient CMS claims data using International Classification of Diseases, ninth edition codes. "Two independent reviewers applied the specific criteria to classify the cases, then we assessed the agreement between them. All discordant cases were discussed, and we arrived at a final consensus diagnosis." The study end points were prevalent epilepsy (ie, those who had epilepsy at baseline) and incident epilepsy (ie, those who developed epilepsy during follow-up).

Incidence and Prevalence Data

Dr. Choi and colleagues found the inter-rater reliability to be high and, in the final analysis, identified 335 participants from the CHS cohort with probable epilepsy at baseline. "This is the group that we used to define an overall epilepsy prevalence of 5.7% out of 5,888 participants," Dr. Choi said. Black participants with a prior history of transient ischemic attack were more likely to have prevalent epilepsy.

In addition, Dr. Choi and colleagues identified 120 participants who developed epilepsy during follow-up, for an overall incidence rate of 2.5 per 1,000 person-years, which is similar to that of prior research by Faught and colleagues, she pointed out. In the current study, the incidence rate was elevated in black participants at 4.2 per 1,000 person-years versus 2.1 per 1,000 person-years for white participants.

In addition, Dr. Choi and colleagues identified 120 participants who developed epilepsy during follow-up for an overall incidence rate of 2.5 per 1,000 person-years, which is similar to that of prior research by Faught and colleagues, she pointed out. In the current study, the incidence rate was elevated in black participants at 4.2 for per 1,000 person-years versus 2.1 per 1,000 person-years for white participants.

Adjustment for Stroke Risk

Epilepsy incidence was highest among participants age 75 to 79; however, the incidence rate dropped among those who were older. Using a model that examined participants with a history of cardiovascular risk factors at CHS baseline, Choi and colleagues found that black race, age 75 to 79, and history of stroke were independent risk factors for incident epilepsy. In a second model, which looked at patients who did not have cardiovascular risk factors prior to CHS enrollment but developed these conditions before the onset of epilepsy, black race and incident stroke were independent risk factors for incident epilepsy.

Dr. Choi acknowledged that survival bias may have occurred, whereby healthy participants were retained in the analysis and the sicker patients, possibly with seizures, died earlier. Also, while the analysis adjusted for stroke risk and stroke incidence (which is disproportionately higher in black older adults), other covariates may be more likely to occur in elderly black patients that may have confounded the relationship and increased epilepsy risk.

—Adriene Marshall

VANCOUVER—At a rate of 2.5 per 1,000 person-years, epilepsy incidence in adults age 65 and older is common, according to a retrospective analysis of clinical and administrative data. "To put these study results in context, this incidence rate is 1.5 times higher than that of Parkinson's disease," said Hyunmi Choi, MD, MS, of Columbia University, New York City. Most important, she said, is the finding that black older adults have double the incidence rate of their white counterparts, independent of stroke. "These findings underscore the need for further studies that directly examine the mechanisms by which race affects epilepsy risk," said Dr. Choi at the 68th Annual Meeting of the American Academy of Neurology.

Geographic and Cultural Diversity

Dr. Choi and colleagues from Columbia University and the University of Washington in Seattle, examined data from the Cardiovascular Health Study (CHS), a prospective cohort study of coronary heart disease and stroke. CHS began in 1989 and enrolled 5,201 adults age 65 and older from multiple regions of the country: Sacramento county, California; Washington county, Maryland; Forsyth county, North Carolina; and Pittsburgh, Pennsylvania. A second cohort of 687 predominantly African American participants was enrolled in 1992. In-person evaluations were conducted at baseline, followed by annual in-person evaluations interspersed with phone calls every six months. "Recently, CHS merged its data with those of the Centers for Medicare and Medicaid Services (CMS)," Dr. Choi said.

The researchers used multiple data sources to identify potential epilepsy cases, including self report, information on antiepileptic medication, hospitalization discharge claims data, and outpatient CMS claims data using International Classification of Diseases, ninth edition codes. "Two independent reviewers applied the specific criteria to classify the cases, then we assessed the agreement between them. All discordant cases were discussed, and we arrived at a final consensus diagnosis." The study end points were prevalent epilepsy (ie, those who had epilepsy at baseline) and incident epilepsy (ie, those who developed epilepsy during follow-up).

Incidence and Prevalence Data

Dr. Choi and colleagues found the inter-rater reliability to be high and, in the final analysis, identified 335 participants from the CHS cohort with probable epilepsy at baseline. "This is the group that we used to define an overall epilepsy prevalence of 5.7% out of 5,888 participants," Dr. Choi said. Black participants with a prior history of transient ischemic attack were more likely to have prevalent epilepsy.

In addition, Dr. Choi and colleagues identified 120 participants who developed epilepsy during follow-up, for an overall incidence rate of 2.5 per 1,000 person-years, which is similar to that of prior research by Faught and colleagues, she pointed out. In the current study, the incidence rate was elevated in black participants at 4.2 per 1,000 person-years versus 2.1 per 1,000 person-years for white participants.

In addition, Dr. Choi and colleagues identified 120 participants who developed epilepsy during follow-up for an overall incidence rate of 2.5 per 1,000 person-years, which is similar to that of prior research by Faught and colleagues, she pointed out. In the current study, the incidence rate was elevated in black participants at 4.2 for per 1,000 person-years versus 2.1 per 1,000 person-years for white participants.

Adjustment for Stroke Risk

Epilepsy incidence was highest among participants age 75 to 79; however, the incidence rate dropped among those who were older. Using a model that examined participants with a history of cardiovascular risk factors at CHS baseline, Choi and colleagues found that black race, age 75 to 79, and history of stroke were independent risk factors for incident epilepsy. In a second model, which looked at patients who did not have cardiovascular risk factors prior to CHS enrollment but developed these conditions before the onset of epilepsy, black race and incident stroke were independent risk factors for incident epilepsy.

Dr. Choi acknowledged that survival bias may have occurred, whereby healthy participants were retained in the analysis and the sicker patients, possibly with seizures, died earlier. Also, while the analysis adjusted for stroke risk and stroke incidence (which is disproportionately higher in black older adults), other covariates may be more likely to occur in elderly black patients that may have confounded the relationship and increased epilepsy risk.

—Adriene Marshall

VANCOUVER—At a rate of 2.5 per 1,000 person-years, epilepsy incidence in adults age 65 and older is common, according to a retrospective analysis of clinical and administrative data. "To put these study results in context, this incidence rate is 1.5 times higher than that of Parkinson's disease," said Hyunmi Choi, MD, MS, of Columbia University, New York City. Most important, she said, is the finding that black older adults have double the incidence rate of their white counterparts, independent of stroke. "These findings underscore the need for further studies that directly examine the mechanisms by which race affects epilepsy risk," said Dr. Choi at the 68th Annual Meeting of the American Academy of Neurology.

Geographic and Cultural Diversity

Dr. Choi and colleagues from Columbia University and the University of Washington in Seattle, examined data from the Cardiovascular Health Study (CHS), a prospective cohort study of coronary heart disease and stroke. CHS began in 1989 and enrolled 5,201 adults age 65 and older from multiple regions of the country: Sacramento county, California; Washington county, Maryland; Forsyth county, North Carolina; and Pittsburgh, Pennsylvania. A second cohort of 687 predominantly African American participants was enrolled in 1992. In-person evaluations were conducted at baseline, followed by annual in-person evaluations interspersed with phone calls every six months. "Recently, CHS merged its data with those of the Centers for Medicare and Medicaid Services (CMS)," Dr. Choi said.

The researchers used multiple data sources to identify potential epilepsy cases, including self report, information on antiepileptic medication, hospitalization discharge claims data, and outpatient CMS claims data using International Classification of Diseases, ninth edition codes. "Two independent reviewers applied the specific criteria to classify the cases, then we assessed the agreement between them. All discordant cases were discussed, and we arrived at a final consensus diagnosis." The study end points were prevalent epilepsy (ie, those who had epilepsy at baseline) and incident epilepsy (ie, those who developed epilepsy during follow-up).

Incidence and Prevalence Data

Dr. Choi and colleagues found the inter-rater reliability to be high and, in the final analysis, identified 335 participants from the CHS cohort with probable epilepsy at baseline. "This is the group that we used to define an overall epilepsy prevalence of 5.7% out of 5,888 participants," Dr. Choi said. Black participants with a prior history of transient ischemic attack were more likely to have prevalent epilepsy.

In addition, Dr. Choi and colleagues identified 120 participants who developed epilepsy during follow-up, for an overall incidence rate of 2.5 per 1,000 person-years, which is similar to that of prior research by Faught and colleagues, she pointed out. In the current study, the incidence rate was elevated in black participants at 4.2 per 1,000 person-years versus 2.1 per 1,000 person-years for white participants.

In addition, Dr. Choi and colleagues identified 120 participants who developed epilepsy during follow-up for an overall incidence rate of 2.5 per 1,000 person-years, which is similar to that of prior research by Faught and colleagues, she pointed out. In the current study, the incidence rate was elevated in black participants at 4.2 for per 1,000 person-years versus 2.1 per 1,000 person-years for white participants.

Adjustment for Stroke Risk

Epilepsy incidence was highest among participants age 75 to 79; however, the incidence rate dropped among those who were older. Using a model that examined participants with a history of cardiovascular risk factors at CHS baseline, Choi and colleagues found that black race, age 75 to 79, and history of stroke were independent risk factors for incident epilepsy. In a second model, which looked at patients who did not have cardiovascular risk factors prior to CHS enrollment but developed these conditions before the onset of epilepsy, black race and incident stroke were independent risk factors for incident epilepsy.

Dr. Choi acknowledged that survival bias may have occurred, whereby healthy participants were retained in the analysis and the sicker patients, possibly with seizures, died earlier. Also, while the analysis adjusted for stroke risk and stroke incidence (which is disproportionately higher in black older adults), other covariates may be more likely to occur in elderly black patients that may have confounded the relationship and increased epilepsy risk.

—Adriene Marshall

WASHINGTON – Are you ready for the way you are paid for seeing patients to change, and not just change, but change dramatically?

The value-based care system of reimbursement for primary care physicians under the Medicare Access and CHIP Reauthorization Act (MACRA) is expected to take effect beginning in 2019, but how those payments will be made will be based on measurements of your overall performance in 2017. Will you be ready?

“Times are changing, and we need to change with them,” says Dr. Nitin Damle, the incoming president of the American College of Physicians, and an internist with South County Internal Medicine, Wakefield, R.I.

In this video, part of a series of roundtable discussions with leading health policy analysts and academic primary care physicians and mental health specialists, Dr. Damle and Dr. Lee Beers, the medical director for municipal and regional affairs at Children’s National Health System, Washington, discuss the essential steps physician practices must take in order to survive – and thrive – in a value-based care environment.

These steps include: team-based care, inclusion of mental health services, flexible IT electronic health record systems, quality measures tailored to your practice’s competencies and patient panel, and adequate funding.

Whether you’ve already begun the transition to a value-based system, or have yet to begin, this video will help focus your efforts and expectations of what’s to come.

“Don’t let perfect be the enemy of good. Start with incremental steps so you can get momentum going so that you end up where you want to be,” says Dr. Beers.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Are you ready for the way you are paid for seeing patients to change, and not just change, but change dramatically?

The value-based care system of reimbursement for primary care physicians under the Medicare Access and CHIP Reauthorization Act (MACRA) is expected to take effect beginning in 2019, but how those payments will be made will be based on measurements of your overall performance in 2017. Will you be ready?

“Times are changing, and we need to change with them,” says Dr. Nitin Damle, the incoming president of the American College of Physicians, and an internist with South County Internal Medicine, Wakefield, R.I.

In this video, part of a series of roundtable discussions with leading health policy analysts and academic primary care physicians and mental health specialists, Dr. Damle and Dr. Lee Beers, the medical director for municipal and regional affairs at Children’s National Health System, Washington, discuss the essential steps physician practices must take in order to survive – and thrive – in a value-based care environment.

These steps include: team-based care, inclusion of mental health services, flexible IT electronic health record systems, quality measures tailored to your practice’s competencies and patient panel, and adequate funding.

Whether you’ve already begun the transition to a value-based system, or have yet to begin, this video will help focus your efforts and expectations of what’s to come.

“Don’t let perfect be the enemy of good. Start with incremental steps so you can get momentum going so that you end up where you want to be,” says Dr. Beers.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Are you ready for the way you are paid for seeing patients to change, and not just change, but change dramatically?

The value-based care system of reimbursement for primary care physicians under the Medicare Access and CHIP Reauthorization Act (MACRA) is expected to take effect beginning in 2019, but how those payments will be made will be based on measurements of your overall performance in 2017. Will you be ready?

“Times are changing, and we need to change with them,” says Dr. Nitin Damle, the incoming president of the American College of Physicians, and an internist with South County Internal Medicine, Wakefield, R.I.

In this video, part of a series of roundtable discussions with leading health policy analysts and academic primary care physicians and mental health specialists, Dr. Damle and Dr. Lee Beers, the medical director for municipal and regional affairs at Children’s National Health System, Washington, discuss the essential steps physician practices must take in order to survive – and thrive – in a value-based care environment.

These steps include: team-based care, inclusion of mental health services, flexible IT electronic health record systems, quality measures tailored to your practice’s competencies and patient panel, and adequate funding.

Whether you’ve already begun the transition to a value-based system, or have yet to begin, this video will help focus your efforts and expectations of what’s to come.

“Don’t let perfect be the enemy of good. Start with incremental steps so you can get momentum going so that you end up where you want to be,” says Dr. Beers.

[email protected]

On Twitter @whitneymcknight

In an attempt to protect patients with epilepsy from harm, clinicians and relatives sometimes take an overcautious view and advise them to avoid sports and exercise. A recent consensus paper from the International League Against Epilepsy (ILAE) Task Force on Sports and Epilepsy provides a more objective evaluation of the benefits and risks of exercise in this patient population, offering suggestions on issuing medical fitness certificates in various sports. The consensus paper divides sports into three categories. In group 1, the paper discusses activities that are not associated with any significant risk; category 2 includes sports that incur significant risk to persons with epilepsy but that do not pose a risk to bystanders, while the third group includes major risk factors for both patients and observers. Among the factors that ILAE takes into account when making its recommendations: the type of sport, the likelihood of a seizure occurring during participation, the type and severity of the seizures, and the "usual timing of seizure occurrence."

Capovilla G, Kaufman KR, Perucca E, Moshé SL, Arida RM. Epilepsy, seizures, physical exercise, and sports: A report from the ILAE Task Force on Sports and Epilepsy. Epilepsia. 2016;57(1):6-12.

In an attempt to protect patients with epilepsy from harm, clinicians and relatives sometimes take an overcautious view and advise them to avoid sports and exercise. A recent consensus paper from the International League Against Epilepsy (ILAE) Task Force on Sports and Epilepsy provides a more objective evaluation of the benefits and risks of exercise in this patient population, offering suggestions on issuing medical fitness certificates in various sports. The consensus paper divides sports into three categories. In group 1, the paper discusses activities that are not associated with any significant risk; category 2 includes sports that incur significant risk to persons with epilepsy but that do not pose a risk to bystanders, while the third group includes major risk factors for both patients and observers. Among the factors that ILAE takes into account when making its recommendations: the type of sport, the likelihood of a seizure occurring during participation, the type and severity of the seizures, and the "usual timing of seizure occurrence."

Capovilla G, Kaufman KR, Perucca E, Moshé SL, Arida RM. Epilepsy, seizures, physical exercise, and sports: A report from the ILAE Task Force on Sports and Epilepsy. Epilepsia. 2016;57(1):6-12.

In an attempt to protect patients with epilepsy from harm, clinicians and relatives sometimes take an overcautious view and advise them to avoid sports and exercise. A recent consensus paper from the International League Against Epilepsy (ILAE) Task Force on Sports and Epilepsy provides a more objective evaluation of the benefits and risks of exercise in this patient population, offering suggestions on issuing medical fitness certificates in various sports. The consensus paper divides sports into three categories. In group 1, the paper discusses activities that are not associated with any significant risk; category 2 includes sports that incur significant risk to persons with epilepsy but that do not pose a risk to bystanders, while the third group includes major risk factors for both patients and observers. Among the factors that ILAE takes into account when making its recommendations: the type of sport, the likelihood of a seizure occurring during participation, the type and severity of the seizures, and the "usual timing of seizure occurrence."

Capovilla G, Kaufman KR, Perucca E, Moshé SL, Arida RM. Epilepsy, seizures, physical exercise, and sports: A report from the ILAE Task Force on Sports and Epilepsy. Epilepsia. 2016;57(1):6-12.

Patients with epilepsy are more likely to have difficulty accessing health care services, according to the National Health Interview Survey during 2010 and 2013. The survey, which included data from more than 27,000 and 34,000 adults in these respective years, revealed that patients with epilepsy had more problems affording medication (relative risk [RR]: 2.40), gaining access to mental health services (RR = 3.23), getting eyeglasses (RR= 2.36), and obtaining dental services (RR = 1.98). Similarly, this patient population was more than five times as likely to report transportation problems as a barrier to obtaining health care services. The survey data suggested that the relative lack of private health insurance may have contributed to these disparities (RR = 0.58).

Thurman DJ, Kobau R, Luo Y-H, Helmers SL, Zack MM. Health-care access among adults with epilepsy: The U.S. National Health Interview Survey, 2010 and 2013. Epilepsy Behav. 2016;55:184-188.

Patients with epilepsy are more likely to have difficulty accessing health care services, according to the National Health Interview Survey during 2010 and 2013. The survey, which included data from more than 27,000 and 34,000 adults in these respective years, revealed that patients with epilepsy had more problems affording medication (relative risk [RR]: 2.40), gaining access to mental health services (RR = 3.23), getting eyeglasses (RR= 2.36), and obtaining dental services (RR = 1.98). Similarly, this patient population was more than five times as likely to report transportation problems as a barrier to obtaining health care services. The survey data suggested that the relative lack of private health insurance may have contributed to these disparities (RR = 0.58).

Thurman DJ, Kobau R, Luo Y-H, Helmers SL, Zack MM. Health-care access among adults with epilepsy: The U.S. National Health Interview Survey, 2010 and 2013. Epilepsy Behav. 2016;55:184-188.

Patients with epilepsy are more likely to have difficulty accessing health care services, according to the National Health Interview Survey during 2010 and 2013. The survey, which included data from more than 27,000 and 34,000 adults in these respective years, revealed that patients with epilepsy had more problems affording medication (relative risk [RR]: 2.40), gaining access to mental health services (RR = 3.23), getting eyeglasses (RR= 2.36), and obtaining dental services (RR = 1.98). Similarly, this patient population was more than five times as likely to report transportation problems as a barrier to obtaining health care services. The survey data suggested that the relative lack of private health insurance may have contributed to these disparities (RR = 0.58).

Thurman DJ, Kobau R, Luo Y-H, Helmers SL, Zack MM. Health-care access among adults with epilepsy: The U.S. National Health Interview Survey, 2010 and 2013. Epilepsy Behav. 2016;55:184-188.

WASHINGTON – Feel free to continue operating under a fee-for-service system, but according to Neil Kirschner, Ph.D., the senior associate for regulatory and insurer affairs at the American College of Physicians, “It’ll slowly be bled. The updates will be less, and will be linked to quality and efficiency.”

But just what is “value-based care” and why is it now, literally, the law of the land?

In this video interview, Dr. Kirschner explains how and why practice is being transformed and what this means in practical terms, and he lists resources for what you can do to ensure your practice is not left behind.

“I think many doctors still are not seeing the change, or not seeing how quickly it’s coming,” says Dr. Kirschner. “Once it comes, it’s going to hit physicians in the face if they’re not prepared.”

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Feel free to continue operating under a fee-for-service system, but according to Neil Kirschner, Ph.D., the senior associate for regulatory and insurer affairs at the American College of Physicians, “It’ll slowly be bled. The updates will be less, and will be linked to quality and efficiency.”

But just what is “value-based care” and why is it now, literally, the law of the land?

In this video interview, Dr. Kirschner explains how and why practice is being transformed and what this means in practical terms, and he lists resources for what you can do to ensure your practice is not left behind.

“I think many doctors still are not seeing the change, or not seeing how quickly it’s coming,” says Dr. Kirschner. “Once it comes, it’s going to hit physicians in the face if they’re not prepared.”

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Feel free to continue operating under a fee-for-service system, but according to Neil Kirschner, Ph.D., the senior associate for regulatory and insurer affairs at the American College of Physicians, “It’ll slowly be bled. The updates will be less, and will be linked to quality and efficiency.”

But just what is “value-based care” and why is it now, literally, the law of the land?

In this video interview, Dr. Kirschner explains how and why practice is being transformed and what this means in practical terms, and he lists resources for what you can do to ensure your practice is not left behind.

“I think many doctors still are not seeing the change, or not seeing how quickly it’s coming,” says Dr. Kirschner. “Once it comes, it’s going to hit physicians in the face if they’re not prepared.”

[email protected]

On Twitter @whitneymcknight

Among 207 patients with epilepsy, 43% reported clinically significant insomnia, while 51% had at least mild insomnia according to investigators from the University of Virginia. Their results, derived from an Insomnia Severity Index survey, also found that younger patients, those with a shorter duration of epilepsy, and patients taking sedatives or hypnotics, reported more severe insomnia. Similarly, patients with delayed sleep timing and depression were more likely to experience more severe insomnia. However, even after researchers factored out these covariates, they found that more severe insomnia was significantly associated with seizures and poorer quality of life.

Quigg M, Gharai S, Ruland J, et al. Insomnia in epilepsy is associated with continuing seizures and worse quality of life. Epilepsy Res. 2016;122:91-96.

Among 207 patients with epilepsy, 43% reported clinically significant insomnia, while 51% had at least mild insomnia according to investigators from the University of Virginia. Their results, derived from an Insomnia Severity Index survey, also found that younger patients, those with a shorter duration of epilepsy, and patients taking sedatives or hypnotics, reported more severe insomnia. Similarly, patients with delayed sleep timing and depression were more likely to experience more severe insomnia. However, even after researchers factored out these covariates, they found that more severe insomnia was significantly associated with seizures and poorer quality of life.

Quigg M, Gharai S, Ruland J, et al. Insomnia in epilepsy is associated with continuing seizures and worse quality of life. Epilepsy Res. 2016;122:91-96.

Among 207 patients with epilepsy, 43% reported clinically significant insomnia, while 51% had at least mild insomnia according to investigators from the University of Virginia. Their results, derived from an Insomnia Severity Index survey, also found that younger patients, those with a shorter duration of epilepsy, and patients taking sedatives or hypnotics, reported more severe insomnia. Similarly, patients with delayed sleep timing and depression were more likely to experience more severe insomnia. However, even after researchers factored out these covariates, they found that more severe insomnia was significantly associated with seizures and poorer quality of life.

Quigg M, Gharai S, Ruland J, et al. Insomnia in epilepsy is associated with continuing seizures and worse quality of life. Epilepsy Res. 2016;122:91-96.

YES: Immediate and safe patient access

Pharmacist-prescribed contraception laws are an opportunity to safely and easily improve access to contraception for women. While over-the-counter access remains an important goal, there are many practical considerations that must be addressed prior to implementation.

For example, in order to change the status of a medication to OTC, each product’s manufacturer needs to apply to the Food and Drug Administration for the change. This application includes studies that demonstrate their product can be safely used by the general public, without guidance from a health professional. The American College of Obstetricians and Gynecologists has already weighed in on the overall safety of oral contraceptives, and some studies have been done that show women can accurately complete a health questionnaire related to their OC eligibility. While these are good steps toward demonstrating safe use, they do not satisfy FDA requirements for OTC status. These initial studies never went to the next step of having women interpret the questions in an “actual use study,” an FDA requirement.

On the other hand, there have been studies demonstrating that pharmacists can safely provide hormonal contraception (J Am Pharm Assoc. 2008 Mar-Apr;48[2]:212-21). State laws can’t overrule the FDA and make hormonal contraception OTC, but they can change the scope of what pharmacists are permitted to do. In Oregon and California, specific laws allowing pharmacists to prescribe hormonal contraception have already been implemented. Speaking from our experience in Oregon, this change has solved many concerns that have been raised about hormonal contraception going OTC.

Maintaining insurance coverage

Since pharmacists are able to write prescriptions, they can bill insurance plans for the product in the same way as for any other prescription. The majority of OTC medications are not covered by insurance and if a future law required insurance to cover contraception obtained OTC, pharmacists would still be involved in billing.

Patients will continue to get counseling

Pharmacists need to undergo training/certification in order to prescribe hormonal contraception. In Oregon, the certification was developed by pharmacists and physicians with input from the Oregon Health Authority and the Oregon Board of Pharmacy. Having a trained health care professional involved in counseling means that accurate and important information is still conveyed, including ensuring women are aware that hormonal contraception is not going to protect against sexually transmitted infections, and teaching women about the importance of adherence, but also how to deal with missed pills and problems. The importance of accessing other preventive health services can also be stressed.

Patients will be appropriately screened for their eligibility

Women who are unable to safely use hormonal contraceptives will be referred for more appropriate methods.

We have the opportunity to act now to prevent unintended pregnancy through pharmacist-prescribed hormonal contraceptives. In addition, allowing pharmacists to directly prescribe hormonal contraceptives provides the opportunity to evaluate the safety, efficacy, and acceptability of the practice. This evidence can then be used to look at the feasibility and possible mechanisms that could be undertaken to safely move hormonal contraceptives to OTC, which helps the OTC movement rather than distracting from it.

Dr. Anderson is an instructor at the Oregon State University College of Pharmacy in Corvallis. Dr. Rodriguez is an assistant professor of ob.gyn. at Oregon Health & Science University in Portland. Dr. Edelman is a professor of ob.gyn. and director of the Oregon Family Planning Fellowship at OHSU. They reported having no relevant financial disclosures.

NO: Exchanging one barrier for another

Birth control is an essential part of women’s health care and the value of contraception has been proven time and again. Not only do oral contraceptives provide women with the ability to choose if, and when, they want to become pregnant, they allow women to have more control over their lives by timing pregnancy around education, careers, and other life goals. Nearly 90% of women in the United States between the ages of 15 and 44 will use a highly effective, reversible method of contraception, such as oral contraceptives, injected contraceptives, cervical rings, contraceptive implants, or intrauterine devices.

Ob.gyns. know from evidence and experience that oral contraceptives are safe enough for OTC access. In fact, oral contraceptives are safer than many other medications that are already available OTC, such as acetaminophen. Of note, thromboembolism, the most common serious risk associated with oral contraceptives, is not only exceedingly low but is also much lower than the risk for thromboembolism during pregnancy and the postpartum period. After all, no diagnosis is required to prescribe oral contraceptives. Of course, ob.gyns. and other women’s health care providers do screen for easily recognizable risk factors, such as smoking. However, research shows that women are very adept at self-screening for any potential risks.

For these reasons, ACOG has long been a public supporter of OTC access to oral contraceptives, as it already is in many countries around the world. ACOG supports efforts to increase affordable, reliable access for American women to the contraceptives they need, when they need them.

However, the pharmacist-prescribing laws do not go far enough in expanding access to contraception. A pharmacist’s prescription simply exchanges one barrier – a physician’s prescription – for another.

Women still need to arrange a consultation with a pharmacist during pharmacy hours and any potential cost associated with that consultation would add out-of-pocket expenses. This will not allow us to reach women who remain underserved by the current prescribing requirements. For example, this may prevent women who are uninsured or underinsured from accessing contraception. For some, the need to visit a health care provider prevents access to contraception.

ACOG continues to stand by full, no-copay coverage of all FDA-approved methods of birth control, under the Affordable Care Act, as we recognize that OTC access to birth control is not a blanket solution. We also continue to strongly advocate for access to long-acting reversible contraceptive methods, the most effective method of preventing pregnancy.

Pharmacists and ob.gyns. alike share a commitment to quality patient care. However, if our shared goal is increasing access to safe, effective contraception, women should be trusted to control their reproductive lives and should be able to do so without barriers.

Dr. DeFrancesco is an ob.gyn. in Cheshire, Conn., and the president of the American College of Obstetricians and Gynecologists. He reported having no relevant financial disclosures.

YES: Immediate and safe patient access

Pharmacist-prescribed contraception laws are an opportunity to safely and easily improve access to contraception for women. While over-the-counter access remains an important goal, there are many practical considerations that must be addressed prior to implementation.

For example, in order to change the status of a medication to OTC, each product’s manufacturer needs to apply to the Food and Drug Administration for the change. This application includes studies that demonstrate their product can be safely used by the general public, without guidance from a health professional. The American College of Obstetricians and Gynecologists has already weighed in on the overall safety of oral contraceptives, and some studies have been done that show women can accurately complete a health questionnaire related to their OC eligibility. While these are good steps toward demonstrating safe use, they do not satisfy FDA requirements for OTC status. These initial studies never went to the next step of having women interpret the questions in an “actual use study,” an FDA requirement.

On the other hand, there have been studies demonstrating that pharmacists can safely provide hormonal contraception (J Am Pharm Assoc. 2008 Mar-Apr;48[2]:212-21). State laws can’t overrule the FDA and make hormonal contraception OTC, but they can change the scope of what pharmacists are permitted to do. In Oregon and California, specific laws allowing pharmacists to prescribe hormonal contraception have already been implemented. Speaking from our experience in Oregon, this change has solved many concerns that have been raised about hormonal contraception going OTC.

Maintaining insurance coverage

Since pharmacists are able to write prescriptions, they can bill insurance plans for the product in the same way as for any other prescription. The majority of OTC medications are not covered by insurance and if a future law required insurance to cover contraception obtained OTC, pharmacists would still be involved in billing.

Patients will continue to get counseling

Pharmacists need to undergo training/certification in order to prescribe hormonal contraception. In Oregon, the certification was developed by pharmacists and physicians with input from the Oregon Health Authority and the Oregon Board of Pharmacy. Having a trained health care professional involved in counseling means that accurate and important information is still conveyed, including ensuring women are aware that hormonal contraception is not going to protect against sexually transmitted infections, and teaching women about the importance of adherence, but also how to deal with missed pills and problems. The importance of accessing other preventive health services can also be stressed.

Patients will be appropriately screened for their eligibility

Women who are unable to safely use hormonal contraceptives will be referred for more appropriate methods.

We have the opportunity to act now to prevent unintended pregnancy through pharmacist-prescribed hormonal contraceptives. In addition, allowing pharmacists to directly prescribe hormonal contraceptives provides the opportunity to evaluate the safety, efficacy, and acceptability of the practice. This evidence can then be used to look at the feasibility and possible mechanisms that could be undertaken to safely move hormonal contraceptives to OTC, which helps the OTC movement rather than distracting from it.

Dr. Anderson is an instructor at the Oregon State University College of Pharmacy in Corvallis. Dr. Rodriguez is an assistant professor of ob.gyn. at Oregon Health & Science University in Portland. Dr. Edelman is a professor of ob.gyn. and director of the Oregon Family Planning Fellowship at OHSU. They reported having no relevant financial disclosures.

NO: Exchanging one barrier for another

Birth control is an essential part of women’s health care and the value of contraception has been proven time and again. Not only do oral contraceptives provide women with the ability to choose if, and when, they want to become pregnant, they allow women to have more control over their lives by timing pregnancy around education, careers, and other life goals. Nearly 90% of women in the United States between the ages of 15 and 44 will use a highly effective, reversible method of contraception, such as oral contraceptives, injected contraceptives, cervical rings, contraceptive implants, or intrauterine devices.

Ob.gyns. know from evidence and experience that oral contraceptives are safe enough for OTC access. In fact, oral contraceptives are safer than many other medications that are already available OTC, such as acetaminophen. Of note, thromboembolism, the most common serious risk associated with oral contraceptives, is not only exceedingly low but is also much lower than the risk for thromboembolism during pregnancy and the postpartum period. After all, no diagnosis is required to prescribe oral contraceptives. Of course, ob.gyns. and other women’s health care providers do screen for easily recognizable risk factors, such as smoking. However, research shows that women are very adept at self-screening for any potential risks.

For these reasons, ACOG has long been a public supporter of OTC access to oral contraceptives, as it already is in many countries around the world. ACOG supports efforts to increase affordable, reliable access for American women to the contraceptives they need, when they need them.

However, the pharmacist-prescribing laws do not go far enough in expanding access to contraception. A pharmacist’s prescription simply exchanges one barrier – a physician’s prescription – for another.

Women still need to arrange a consultation with a pharmacist during pharmacy hours and any potential cost associated with that consultation would add out-of-pocket expenses. This will not allow us to reach women who remain underserved by the current prescribing requirements. For example, this may prevent women who are uninsured or underinsured from accessing contraception. For some, the need to visit a health care provider prevents access to contraception.

ACOG continues to stand by full, no-copay coverage of all FDA-approved methods of birth control, under the Affordable Care Act, as we recognize that OTC access to birth control is not a blanket solution. We also continue to strongly advocate for access to long-acting reversible contraceptive methods, the most effective method of preventing pregnancy.

Pharmacists and ob.gyns. alike share a commitment to quality patient care. However, if our shared goal is increasing access to safe, effective contraception, women should be trusted to control their reproductive lives and should be able to do so without barriers.

Dr. DeFrancesco is an ob.gyn. in Cheshire, Conn., and the president of the American College of Obstetricians and Gynecologists. He reported having no relevant financial disclosures.

YES: Immediate and safe patient access

Pharmacist-prescribed contraception laws are an opportunity to safely and easily improve access to contraception for women. While over-the-counter access remains an important goal, there are many practical considerations that must be addressed prior to implementation.

For example, in order to change the status of a medication to OTC, each product’s manufacturer needs to apply to the Food and Drug Administration for the change. This application includes studies that demonstrate their product can be safely used by the general public, without guidance from a health professional. The American College of Obstetricians and Gynecologists has already weighed in on the overall safety of oral contraceptives, and some studies have been done that show women can accurately complete a health questionnaire related to their OC eligibility. While these are good steps toward demonstrating safe use, they do not satisfy FDA requirements for OTC status. These initial studies never went to the next step of having women interpret the questions in an “actual use study,” an FDA requirement.

On the other hand, there have been studies demonstrating that pharmacists can safely provide hormonal contraception (J Am Pharm Assoc. 2008 Mar-Apr;48[2]:212-21). State laws can’t overrule the FDA and make hormonal contraception OTC, but they can change the scope of what pharmacists are permitted to do. In Oregon and California, specific laws allowing pharmacists to prescribe hormonal contraception have already been implemented. Speaking from our experience in Oregon, this change has solved many concerns that have been raised about hormonal contraception going OTC.

Maintaining insurance coverage

Since pharmacists are able to write prescriptions, they can bill insurance plans for the product in the same way as for any other prescription. The majority of OTC medications are not covered by insurance and if a future law required insurance to cover contraception obtained OTC, pharmacists would still be involved in billing.

Patients will continue to get counseling

Pharmacists need to undergo training/certification in order to prescribe hormonal contraception. In Oregon, the certification was developed by pharmacists and physicians with input from the Oregon Health Authority and the Oregon Board of Pharmacy. Having a trained health care professional involved in counseling means that accurate and important information is still conveyed, including ensuring women are aware that hormonal contraception is not going to protect against sexually transmitted infections, and teaching women about the importance of adherence, but also how to deal with missed pills and problems. The importance of accessing other preventive health services can also be stressed.

Patients will be appropriately screened for their eligibility

Women who are unable to safely use hormonal contraceptives will be referred for more appropriate methods.

We have the opportunity to act now to prevent unintended pregnancy through pharmacist-prescribed hormonal contraceptives. In addition, allowing pharmacists to directly prescribe hormonal contraceptives provides the opportunity to evaluate the safety, efficacy, and acceptability of the practice. This evidence can then be used to look at the feasibility and possible mechanisms that could be undertaken to safely move hormonal contraceptives to OTC, which helps the OTC movement rather than distracting from it.

Dr. Anderson is an instructor at the Oregon State University College of Pharmacy in Corvallis. Dr. Rodriguez is an assistant professor of ob.gyn. at Oregon Health & Science University in Portland. Dr. Edelman is a professor of ob.gyn. and director of the Oregon Family Planning Fellowship at OHSU. They reported having no relevant financial disclosures.

NO: Exchanging one barrier for another

Birth control is an essential part of women’s health care and the value of contraception has been proven time and again. Not only do oral contraceptives provide women with the ability to choose if, and when, they want to become pregnant, they allow women to have more control over their lives by timing pregnancy around education, careers, and other life goals. Nearly 90% of women in the United States between the ages of 15 and 44 will use a highly effective, reversible method of contraception, such as oral contraceptives, injected contraceptives, cervical rings, contraceptive implants, or intrauterine devices.

Ob.gyns. know from evidence and experience that oral contraceptives are safe enough for OTC access. In fact, oral contraceptives are safer than many other medications that are already available OTC, such as acetaminophen. Of note, thromboembolism, the most common serious risk associated with oral contraceptives, is not only exceedingly low but is also much lower than the risk for thromboembolism during pregnancy and the postpartum period. After all, no diagnosis is required to prescribe oral contraceptives. Of course, ob.gyns. and other women’s health care providers do screen for easily recognizable risk factors, such as smoking. However, research shows that women are very adept at self-screening for any potential risks.

For these reasons, ACOG has long been a public supporter of OTC access to oral contraceptives, as it already is in many countries around the world. ACOG supports efforts to increase affordable, reliable access for American women to the contraceptives they need, when they need them.

However, the pharmacist-prescribing laws do not go far enough in expanding access to contraception. A pharmacist’s prescription simply exchanges one barrier – a physician’s prescription – for another.

Women still need to arrange a consultation with a pharmacist during pharmacy hours and any potential cost associated with that consultation would add out-of-pocket expenses. This will not allow us to reach women who remain underserved by the current prescribing requirements. For example, this may prevent women who are uninsured or underinsured from accessing contraception. For some, the need to visit a health care provider prevents access to contraception.

ACOG continues to stand by full, no-copay coverage of all FDA-approved methods of birth control, under the Affordable Care Act, as we recognize that OTC access to birth control is not a blanket solution. We also continue to strongly advocate for access to long-acting reversible contraceptive methods, the most effective method of preventing pregnancy.

Pharmacists and ob.gyns. alike share a commitment to quality patient care. However, if our shared goal is increasing access to safe, effective contraception, women should be trusted to control their reproductive lives and should be able to do so without barriers.

Dr. DeFrancesco is an ob.gyn. in Cheshire, Conn., and the president of the American College of Obstetricians and Gynecologists. He reported having no relevant financial disclosures.