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A qualitative study of the use of a clinical decision support tool in pediatric diarrhea identified the expectations of clinicians and the concerns of parents surrounding the tool’s use.

“Clinical decision support tools are designed to assist clinicians in making informed and accurate diagnostic and prognostic decisions using available characteristics of the patient and the larger context,” Anna Jones, MD, MPH, and her colleagues wrote in JAMA Network Open.

Jones is in the Department of Pediatrics at the University of Utah School of Medicine in Salt Lake City.

Jones and her coauthors concluded such a tool had the potential to improve evidence-based testing in pediatric diarrhea and help clinicians communicate clearly to parents the etiology of their child’s illness. Parents in the study, however, expressed skepticism over the tool, voicing concerns that physicians might over-rely on its algorithms.

The authors said that thanks to the development of multiplex polymerase chain reaction (PCR) panels for gastroenteritis, it is now possible to quickly identify up to 22 different pathogens from stool samples. What is lacking, they suggested, are protocols for knowing when to test for these pathogens.

“Although the Infectious Diseases Society of America 2017 clinical practice guidelines for the diagnosis and management of infectious diarrhea provide broad recommendations for when diarrhea-related diagnostics should be used, clear guidelines specific to the use of multiplex PCR panels do not exist,” Jones and her coauthors wrote, adding that misusing the diagnostics, however, “can lead to inappropriate antibiotic use and excess financial burdens.”

Meanwhile, communication breakdowns in the patient-doctor relationship are a leading contributor to diagnostic errors, according to the Agency for Healthcare Research and Quality. Subsequently, the National Academy of Medicine has recommended that healthcare professionals seek to engage patients and their families in the diagnostic process.

With these factors in mind, Jones and her colleagues recruited parents who had sought care for their child’s diarrhea and clinicians who routinely treat children with diarrhea. The recruits came from five urgent care sites and one emergency department (ED), all in Utah. Participants were interviewed between June 15, 2023, and January 24, 2025.

In all, the authors interviewed 44 parents (40 women; median age, 34 years). One parent (2%) identified as Asian, two (5%) as Black or African American, 15 (34%) as Hispanic or Latin, and 22 (50%) as White individuals. The remaining four participants (9%) were of unknown race and ethnicity. Most parents spoke English as their primary language (40 [91%]).

Among the 16 clinicians, 10 were physicians and six were nurse practitioners or physician associates. Eleven of the 16 were women and the group had a median age of 42 years. Fourteen clinicians (88%) self-identified as White individuals and two (13%) had unknown race and ethnicity.

All were interviewed on their management of pediatric diarrhea and about their expectations for diagnostic testing and treatment of the condition, as well as the perceived utility of a clinical decision support tool.

Jones and colleagues identified three motivations among parents who sought clinical care for a child with diarrhea. The first was reassurance, which the authors said included validation for what the parents were already doing to care for their child.

The second motivation was to obtain insight into the etiology of their child’s symptoms. “Many believed that diagnostic testing to identify the specific etiology of the illness would be useful. Parents indicated that knowing the etiology would offer desired reassurance and potentially inform treatment decisions,” Jones and her coauthors wrote.

Lastly, parents sought appropriate treatment and symptom relief.

Many clinicians acknowledged the benefits of a clinical decision support tool for help with evidence-based decision-making during diagnosis and to facilitate communication with families. However, they expressed skepticism over the use of diagnostics for etiology, noting that disease management was not dependent upon knowing it.

Some clinicians said many families expected a test. “Even if I don’t think that a GI [gastrointestinal] stool study is necessary, there are situations where…a family is not going to leave the [ED] happy without one. And so I probably order them sometimes when they’re not truly indicated,” a physician reported in the interview.

“That said,” Jones and her coauthors wrote, “clinicians thought that diagnostic testing for pediatric diarrhea was generally not warranted, except in unique cases [such as] bloody stools, prolonged duration of diarrhea, or travel history.”

Many clinicians thought a decision-making tool might help build trust and rapport with the patient’s family, reassuring them their child is getting evidence-based care.

“It just adds to that shared decision-making model. I think it adds trust…I think it does kind of back up our ability to defend why we’re doing what we’re doing,” reported one surveyed ED physician.

Parents were mostly wary of the potential use of a clinical decision-making tool. Jones and colleagues reported that in addition to some clinicians, “several parents expressed concerns that a tool does not account for nuances and would lead to ‘generalizing every kid’ (said the father of a child aged 1-3 years), as opposed to providing patient-centered care.”

Parents also said they worried a clinician would not reply upon their own clinical judgement if they had a diagnostic tool.

Jones and her colleagues concluded that before implementing a clinical decision support tool in pediatric diarrhea, strategies are necessary to, “resolve tension in care expectations, facilitate diagnostic stewardship, and optimize care.”

In an accompanying editorial, KC Coffey, MD, MPH, concluded that the study by Jones and colleagues suggests that adapting such tools to incorporate parental expectations, “could facilitate patient engagement in the diagnostic process and increase acceptance of [using these tools for] decisions. Such discussions might also raise awareness of the potential harms of over testing.” Coffey is an epidemiologist and infectious disease physician at the University of Maryland in Baltimore.

Elizabeth Dobler, MD, who was not involved in the study, told GI & Hepatology News that “as the number of available tests continues to grow, stewardship is becoming more relevant than ever. Families may not always realize the downsides of unnecessary testing — such as false positives, avoidable procedures, or added risks — and part of our responsibility is to help them understand both the potential benefits and the potential harms of these tests.”

Dobler is the medical director for clinical decision support in the Department of Clinical Informatics at Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago.

Clinical decision support tools are helpful in the clinical setting, Dobler said because “they give providers quick access to the most relevant information needed for decision-making. This includes patient-specific details — symptoms, history, labs, and vitals” as well as the characteristics and downsides of the tests. In an ideal world, she said, clinicians would consider these data for every patient.

Dobler cautioned however, that, “it’s important to stress that these tools don’t replace clinical judgment — the provider still evaluates the patient, considers the clinical context, and incorporates the family’s preferences. But as a complement to that process, I believe these tools are very valuable.”

Lastly, Dobler said that transparency is key to helping parents overcome their hesitancy regarding these tools.

Jones, Coffey, and Dobler reported no relevant financial disclosures.

A version of this article appeared on Medscape.com.

A qualitative study of the use of a clinical decision support tool in pediatric diarrhea identified the expectations of clinicians and the concerns of parents surrounding the tool’s use.

“Clinical decision support tools are designed to assist clinicians in making informed and accurate diagnostic and prognostic decisions using available characteristics of the patient and the larger context,” Anna Jones, MD, MPH, and her colleagues wrote in JAMA Network Open.

Jones is in the Department of Pediatrics at the University of Utah School of Medicine in Salt Lake City.

Jones and her coauthors concluded such a tool had the potential to improve evidence-based testing in pediatric diarrhea and help clinicians communicate clearly to parents the etiology of their child’s illness. Parents in the study, however, expressed skepticism over the tool, voicing concerns that physicians might over-rely on its algorithms.

The authors said that thanks to the development of multiplex polymerase chain reaction (PCR) panels for gastroenteritis, it is now possible to quickly identify up to 22 different pathogens from stool samples. What is lacking, they suggested, are protocols for knowing when to test for these pathogens.

“Although the Infectious Diseases Society of America 2017 clinical practice guidelines for the diagnosis and management of infectious diarrhea provide broad recommendations for when diarrhea-related diagnostics should be used, clear guidelines specific to the use of multiplex PCR panels do not exist,” Jones and her coauthors wrote, adding that misusing the diagnostics, however, “can lead to inappropriate antibiotic use and excess financial burdens.”

Meanwhile, communication breakdowns in the patient-doctor relationship are a leading contributor to diagnostic errors, according to the Agency for Healthcare Research and Quality. Subsequently, the National Academy of Medicine has recommended that healthcare professionals seek to engage patients and their families in the diagnostic process.

With these factors in mind, Jones and her colleagues recruited parents who had sought care for their child’s diarrhea and clinicians who routinely treat children with diarrhea. The recruits came from five urgent care sites and one emergency department (ED), all in Utah. Participants were interviewed between June 15, 2023, and January 24, 2025.

In all, the authors interviewed 44 parents (40 women; median age, 34 years). One parent (2%) identified as Asian, two (5%) as Black or African American, 15 (34%) as Hispanic or Latin, and 22 (50%) as White individuals. The remaining four participants (9%) were of unknown race and ethnicity. Most parents spoke English as their primary language (40 [91%]).

Among the 16 clinicians, 10 were physicians and six were nurse practitioners or physician associates. Eleven of the 16 were women and the group had a median age of 42 years. Fourteen clinicians (88%) self-identified as White individuals and two (13%) had unknown race and ethnicity.

All were interviewed on their management of pediatric diarrhea and about their expectations for diagnostic testing and treatment of the condition, as well as the perceived utility of a clinical decision support tool.

Jones and colleagues identified three motivations among parents who sought clinical care for a child with diarrhea. The first was reassurance, which the authors said included validation for what the parents were already doing to care for their child.

The second motivation was to obtain insight into the etiology of their child’s symptoms. “Many believed that diagnostic testing to identify the specific etiology of the illness would be useful. Parents indicated that knowing the etiology would offer desired reassurance and potentially inform treatment decisions,” Jones and her coauthors wrote.

Lastly, parents sought appropriate treatment and symptom relief.

Many clinicians acknowledged the benefits of a clinical decision support tool for help with evidence-based decision-making during diagnosis and to facilitate communication with families. However, they expressed skepticism over the use of diagnostics for etiology, noting that disease management was not dependent upon knowing it.

Some clinicians said many families expected a test. “Even if I don’t think that a GI [gastrointestinal] stool study is necessary, there are situations where…a family is not going to leave the [ED] happy without one. And so I probably order them sometimes when they’re not truly indicated,” a physician reported in the interview.

“That said,” Jones and her coauthors wrote, “clinicians thought that diagnostic testing for pediatric diarrhea was generally not warranted, except in unique cases [such as] bloody stools, prolonged duration of diarrhea, or travel history.”

Many clinicians thought a decision-making tool might help build trust and rapport with the patient’s family, reassuring them their child is getting evidence-based care.

“It just adds to that shared decision-making model. I think it adds trust…I think it does kind of back up our ability to defend why we’re doing what we’re doing,” reported one surveyed ED physician.

Parents were mostly wary of the potential use of a clinical decision-making tool. Jones and colleagues reported that in addition to some clinicians, “several parents expressed concerns that a tool does not account for nuances and would lead to ‘generalizing every kid’ (said the father of a child aged 1-3 years), as opposed to providing patient-centered care.”

Parents also said they worried a clinician would not reply upon their own clinical judgement if they had a diagnostic tool.

Jones and her colleagues concluded that before implementing a clinical decision support tool in pediatric diarrhea, strategies are necessary to, “resolve tension in care expectations, facilitate diagnostic stewardship, and optimize care.”

In an accompanying editorial, KC Coffey, MD, MPH, concluded that the study by Jones and colleagues suggests that adapting such tools to incorporate parental expectations, “could facilitate patient engagement in the diagnostic process and increase acceptance of [using these tools for] decisions. Such discussions might also raise awareness of the potential harms of over testing.” Coffey is an epidemiologist and infectious disease physician at the University of Maryland in Baltimore.

Elizabeth Dobler, MD, who was not involved in the study, told GI & Hepatology News that “as the number of available tests continues to grow, stewardship is becoming more relevant than ever. Families may not always realize the downsides of unnecessary testing — such as false positives, avoidable procedures, or added risks — and part of our responsibility is to help them understand both the potential benefits and the potential harms of these tests.”

Dobler is the medical director for clinical decision support in the Department of Clinical Informatics at Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago.

Clinical decision support tools are helpful in the clinical setting, Dobler said because “they give providers quick access to the most relevant information needed for decision-making. This includes patient-specific details — symptoms, history, labs, and vitals” as well as the characteristics and downsides of the tests. In an ideal world, she said, clinicians would consider these data for every patient.

Dobler cautioned however, that, “it’s important to stress that these tools don’t replace clinical judgment — the provider still evaluates the patient, considers the clinical context, and incorporates the family’s preferences. But as a complement to that process, I believe these tools are very valuable.”

Lastly, Dobler said that transparency is key to helping parents overcome their hesitancy regarding these tools.

Jones, Coffey, and Dobler reported no relevant financial disclosures.

A version of this article appeared on Medscape.com.

A qualitative study of the use of a clinical decision support tool in pediatric diarrhea identified the expectations of clinicians and the concerns of parents surrounding the tool’s use.

“Clinical decision support tools are designed to assist clinicians in making informed and accurate diagnostic and prognostic decisions using available characteristics of the patient and the larger context,” Anna Jones, MD, MPH, and her colleagues wrote in JAMA Network Open.

Jones is in the Department of Pediatrics at the University of Utah School of Medicine in Salt Lake City.

Jones and her coauthors concluded such a tool had the potential to improve evidence-based testing in pediatric diarrhea and help clinicians communicate clearly to parents the etiology of their child’s illness. Parents in the study, however, expressed skepticism over the tool, voicing concerns that physicians might over-rely on its algorithms.

The authors said that thanks to the development of multiplex polymerase chain reaction (PCR) panels for gastroenteritis, it is now possible to quickly identify up to 22 different pathogens from stool samples. What is lacking, they suggested, are protocols for knowing when to test for these pathogens.

“Although the Infectious Diseases Society of America 2017 clinical practice guidelines for the diagnosis and management of infectious diarrhea provide broad recommendations for when diarrhea-related diagnostics should be used, clear guidelines specific to the use of multiplex PCR panels do not exist,” Jones and her coauthors wrote, adding that misusing the diagnostics, however, “can lead to inappropriate antibiotic use and excess financial burdens.”

Meanwhile, communication breakdowns in the patient-doctor relationship are a leading contributor to diagnostic errors, according to the Agency for Healthcare Research and Quality. Subsequently, the National Academy of Medicine has recommended that healthcare professionals seek to engage patients and their families in the diagnostic process.

With these factors in mind, Jones and her colleagues recruited parents who had sought care for their child’s diarrhea and clinicians who routinely treat children with diarrhea. The recruits came from five urgent care sites and one emergency department (ED), all in Utah. Participants were interviewed between June 15, 2023, and January 24, 2025.

In all, the authors interviewed 44 parents (40 women; median age, 34 years). One parent (2%) identified as Asian, two (5%) as Black or African American, 15 (34%) as Hispanic or Latin, and 22 (50%) as White individuals. The remaining four participants (9%) were of unknown race and ethnicity. Most parents spoke English as their primary language (40 [91%]).

Among the 16 clinicians, 10 were physicians and six were nurse practitioners or physician associates. Eleven of the 16 were women and the group had a median age of 42 years. Fourteen clinicians (88%) self-identified as White individuals and two (13%) had unknown race and ethnicity.

All were interviewed on their management of pediatric diarrhea and about their expectations for diagnostic testing and treatment of the condition, as well as the perceived utility of a clinical decision support tool.

Jones and colleagues identified three motivations among parents who sought clinical care for a child with diarrhea. The first was reassurance, which the authors said included validation for what the parents were already doing to care for their child.

The second motivation was to obtain insight into the etiology of their child’s symptoms. “Many believed that diagnostic testing to identify the specific etiology of the illness would be useful. Parents indicated that knowing the etiology would offer desired reassurance and potentially inform treatment decisions,” Jones and her coauthors wrote.

Lastly, parents sought appropriate treatment and symptom relief.

Many clinicians acknowledged the benefits of a clinical decision support tool for help with evidence-based decision-making during diagnosis and to facilitate communication with families. However, they expressed skepticism over the use of diagnostics for etiology, noting that disease management was not dependent upon knowing it.

Some clinicians said many families expected a test. “Even if I don’t think that a GI [gastrointestinal] stool study is necessary, there are situations where…a family is not going to leave the [ED] happy without one. And so I probably order them sometimes when they’re not truly indicated,” a physician reported in the interview.

“That said,” Jones and her coauthors wrote, “clinicians thought that diagnostic testing for pediatric diarrhea was generally not warranted, except in unique cases [such as] bloody stools, prolonged duration of diarrhea, or travel history.”

Many clinicians thought a decision-making tool might help build trust and rapport with the patient’s family, reassuring them their child is getting evidence-based care.

“It just adds to that shared decision-making model. I think it adds trust…I think it does kind of back up our ability to defend why we’re doing what we’re doing,” reported one surveyed ED physician.

Parents were mostly wary of the potential use of a clinical decision-making tool. Jones and colleagues reported that in addition to some clinicians, “several parents expressed concerns that a tool does not account for nuances and would lead to ‘generalizing every kid’ (said the father of a child aged 1-3 years), as opposed to providing patient-centered care.”

Parents also said they worried a clinician would not reply upon their own clinical judgement if they had a diagnostic tool.

Jones and her colleagues concluded that before implementing a clinical decision support tool in pediatric diarrhea, strategies are necessary to, “resolve tension in care expectations, facilitate diagnostic stewardship, and optimize care.”

In an accompanying editorial, KC Coffey, MD, MPH, concluded that the study by Jones and colleagues suggests that adapting such tools to incorporate parental expectations, “could facilitate patient engagement in the diagnostic process and increase acceptance of [using these tools for] decisions. Such discussions might also raise awareness of the potential harms of over testing.” Coffey is an epidemiologist and infectious disease physician at the University of Maryland in Baltimore.

Elizabeth Dobler, MD, who was not involved in the study, told GI & Hepatology News that “as the number of available tests continues to grow, stewardship is becoming more relevant than ever. Families may not always realize the downsides of unnecessary testing — such as false positives, avoidable procedures, or added risks — and part of our responsibility is to help them understand both the potential benefits and the potential harms of these tests.”

Dobler is the medical director for clinical decision support in the Department of Clinical Informatics at Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago.

Clinical decision support tools are helpful in the clinical setting, Dobler said because “they give providers quick access to the most relevant information needed for decision-making. This includes patient-specific details — symptoms, history, labs, and vitals” as well as the characteristics and downsides of the tests. In an ideal world, she said, clinicians would consider these data for every patient.

Dobler cautioned however, that, “it’s important to stress that these tools don’t replace clinical judgment — the provider still evaluates the patient, considers the clinical context, and incorporates the family’s preferences. But as a complement to that process, I believe these tools are very valuable.”

Lastly, Dobler said that transparency is key to helping parents overcome their hesitancy regarding these tools.

Jones, Coffey, and Dobler reported no relevant financial disclosures.

A version of this article appeared on Medscape.com.

PHOENIX – Medications used in oncology clinical trials pose unique challenges in areas such as labeling, packaging, and administration, a US Department of Veterans Affairs (VA) pharmacist cautioned colleagues, and placebos have special needs too.

Even basic safety protections can be lacking when a drug is investigational, said Emily Hennes, PharmD, BCOP, clinical pharmacy specialist for research at William S. Middleton Memorial Veterans Hospital in Shorewood Hills, Wisconsin, in a presentation at the annual meeting of the Association of VA Hematology/Oncology.

“All of the safety features that we have come to know and love in dispensing commercial drugs are absent. There’s no Tall Man lettering, there's no color differentiation, and there's no barcoding, because these are not registered drugs," she said.

A 2017 report found that 81% of pharmacists surveyed indicated some level of concern regarding the safety risk in using  investigational drugs. At the same time, Hennes noted, the Joint Commission has mandated that pharmacists must control the storage, dispensing, labeling, and distribution of investigational medications.

Here are things to know about the use of investigational cancer drugs:

Drug Interactions Are Common

Hennes highlighted a 2023 study of medication reconciliation of 501 patients in 79 clinical trials that found alarming levels of drug interactions: 

• 360 clinically relevant drug-drug interactions were identified among 189 patients, including 158 therapies that were prohibited by protocols. Of these, 57.7% involved cytochrome P450 enzymes, which are involved in metabolism. 

• Reconciliation revealed that 35.2% of medications were not otherwise known or documented.

• A median of 2 previously unknown therapies per patient was discovered in 74% of patients.

• Alternative medicine products such as supplements and over-the-counter drugs were implicated in 60% of identified drug interactions.

• Only 41% of oncologists discussed alternative medicine use with patients, which Hennes attributed to “lack of familiarity with many alternative medicine products or insufficient training.”

To make things more complicated, “We sometimes don’t know the full pharmacokinetic and pharmacodynamic profile of an investigational agent,” she said. 

Naming and Labeling May Not Be Standard

Investigational products may not have genetic names and instead have an alphanumeric identifier such as INV54826 that can be quite similar to other products, she said. Investigational drugs may even go through name changes, forcing pharmacists to be alerted to protect patients. 

In addition, labeling may not be standardized. Drugs may arrive unlabeled, with the wrong volume and size, and lack of barcoding. In some cases, pharmacists choose to put new, patient-friendly labels on these products, Hennes said. 

Information Distribution is Key

“Something that comes up in our practice quite a bit is that there’s no standard drug reference regarding investigational drugs,” Hennes said. “Finding ways to get key information to staff at the point of care is really critical to make sure we’re able to safely treat our patients.”

Precautions May Be Needed to Maintain Blinding Protocols 

Hennes explained that pharmacists must use opaque brown bag covers to maintain blinding when parenteral products have distinctive colors. Lines may have to be covered too, which can create challenges during administration. 

“Pumps aren’t meant to run lines that are covered,” she said, which can lead to jams. “If you don’t do education with your point of care staff, it can cause a lot of confusion.” 

It’s also important for blinding purposes to keep an eye on how long it takes to prepare a treatment, she said. A study’s integrity, for example, could be violated if a complex investigational product takes an hour to equilibrate to room temperature and 20-30 minutes to prepare, while a placebo only requires “drawing a few mils of saline out of a bag and labeling it.”

Education for Patients Can Be Useful 

Hennes urged colleagues to remind patients to save investigational medication at the end of each cycle and return it to the clinic site for accountability.

She also suggested creating treatment calendars/reminders for patients and discussing adherence strategies with them. 

Hennes reported no disclosures. 

PHOENIX – Medications used in oncology clinical trials pose unique challenges in areas such as labeling, packaging, and administration, a US Department of Veterans Affairs (VA) pharmacist cautioned colleagues, and placebos have special needs too.

Even basic safety protections can be lacking when a drug is investigational, said Emily Hennes, PharmD, BCOP, clinical pharmacy specialist for research at William S. Middleton Memorial Veterans Hospital in Shorewood Hills, Wisconsin, in a presentation at the annual meeting of the Association of VA Hematology/Oncology.

“All of the safety features that we have come to know and love in dispensing commercial drugs are absent. There’s no Tall Man lettering, there's no color differentiation, and there's no barcoding, because these are not registered drugs," she said.

A 2017 report found that 81% of pharmacists surveyed indicated some level of concern regarding the safety risk in using  investigational drugs. At the same time, Hennes noted, the Joint Commission has mandated that pharmacists must control the storage, dispensing, labeling, and distribution of investigational medications.

Here are things to know about the use of investigational cancer drugs:

Drug Interactions Are Common

Hennes highlighted a 2023 study of medication reconciliation of 501 patients in 79 clinical trials that found alarming levels of drug interactions: 

• 360 clinically relevant drug-drug interactions were identified among 189 patients, including 158 therapies that were prohibited by protocols. Of these, 57.7% involved cytochrome P450 enzymes, which are involved in metabolism. 

• Reconciliation revealed that 35.2% of medications were not otherwise known or documented.

• A median of 2 previously unknown therapies per patient was discovered in 74% of patients.

• Alternative medicine products such as supplements and over-the-counter drugs were implicated in 60% of identified drug interactions.

• Only 41% of oncologists discussed alternative medicine use with patients, which Hennes attributed to “lack of familiarity with many alternative medicine products or insufficient training.”

To make things more complicated, “We sometimes don’t know the full pharmacokinetic and pharmacodynamic profile of an investigational agent,” she said. 

Naming and Labeling May Not Be Standard

Investigational products may not have genetic names and instead have an alphanumeric identifier such as INV54826 that can be quite similar to other products, she said. Investigational drugs may even go through name changes, forcing pharmacists to be alerted to protect patients. 

In addition, labeling may not be standardized. Drugs may arrive unlabeled, with the wrong volume and size, and lack of barcoding. In some cases, pharmacists choose to put new, patient-friendly labels on these products, Hennes said. 

Information Distribution is Key

“Something that comes up in our practice quite a bit is that there’s no standard drug reference regarding investigational drugs,” Hennes said. “Finding ways to get key information to staff at the point of care is really critical to make sure we’re able to safely treat our patients.”

Precautions May Be Needed to Maintain Blinding Protocols 

Hennes explained that pharmacists must use opaque brown bag covers to maintain blinding when parenteral products have distinctive colors. Lines may have to be covered too, which can create challenges during administration. 

“Pumps aren’t meant to run lines that are covered,” she said, which can lead to jams. “If you don’t do education with your point of care staff, it can cause a lot of confusion.” 

It’s also important for blinding purposes to keep an eye on how long it takes to prepare a treatment, she said. A study’s integrity, for example, could be violated if a complex investigational product takes an hour to equilibrate to room temperature and 20-30 minutes to prepare, while a placebo only requires “drawing a few mils of saline out of a bag and labeling it.”

Education for Patients Can Be Useful 

Hennes urged colleagues to remind patients to save investigational medication at the end of each cycle and return it to the clinic site for accountability.

She also suggested creating treatment calendars/reminders for patients and discussing adherence strategies with them. 

Hennes reported no disclosures. 

PHOENIX – Medications used in oncology clinical trials pose unique challenges in areas such as labeling, packaging, and administration, a US Department of Veterans Affairs (VA) pharmacist cautioned colleagues, and placebos have special needs too.

Even basic safety protections can be lacking when a drug is investigational, said Emily Hennes, PharmD, BCOP, clinical pharmacy specialist for research at William S. Middleton Memorial Veterans Hospital in Shorewood Hills, Wisconsin, in a presentation at the annual meeting of the Association of VA Hematology/Oncology.

“All of the safety features that we have come to know and love in dispensing commercial drugs are absent. There’s no Tall Man lettering, there's no color differentiation, and there's no barcoding, because these are not registered drugs," she said.

A 2017 report found that 81% of pharmacists surveyed indicated some level of concern regarding the safety risk in using  investigational drugs. At the same time, Hennes noted, the Joint Commission has mandated that pharmacists must control the storage, dispensing, labeling, and distribution of investigational medications.

Here are things to know about the use of investigational cancer drugs:

Drug Interactions Are Common

Hennes highlighted a 2023 study of medication reconciliation of 501 patients in 79 clinical trials that found alarming levels of drug interactions: 

• 360 clinically relevant drug-drug interactions were identified among 189 patients, including 158 therapies that were prohibited by protocols. Of these, 57.7% involved cytochrome P450 enzymes, which are involved in metabolism. 

• Reconciliation revealed that 35.2% of medications were not otherwise known or documented.

• A median of 2 previously unknown therapies per patient was discovered in 74% of patients.

• Alternative medicine products such as supplements and over-the-counter drugs were implicated in 60% of identified drug interactions.

• Only 41% of oncologists discussed alternative medicine use with patients, which Hennes attributed to “lack of familiarity with many alternative medicine products or insufficient training.”

To make things more complicated, “We sometimes don’t know the full pharmacokinetic and pharmacodynamic profile of an investigational agent,” she said. 

Naming and Labeling May Not Be Standard

Investigational products may not have genetic names and instead have an alphanumeric identifier such as INV54826 that can be quite similar to other products, she said. Investigational drugs may even go through name changes, forcing pharmacists to be alerted to protect patients. 

In addition, labeling may not be standardized. Drugs may arrive unlabeled, with the wrong volume and size, and lack of barcoding. In some cases, pharmacists choose to put new, patient-friendly labels on these products, Hennes said. 

Information Distribution is Key

“Something that comes up in our practice quite a bit is that there’s no standard drug reference regarding investigational drugs,” Hennes said. “Finding ways to get key information to staff at the point of care is really critical to make sure we’re able to safely treat our patients.”

Precautions May Be Needed to Maintain Blinding Protocols 

Hennes explained that pharmacists must use opaque brown bag covers to maintain blinding when parenteral products have distinctive colors. Lines may have to be covered too, which can create challenges during administration. 

“Pumps aren’t meant to run lines that are covered,” she said, which can lead to jams. “If you don’t do education with your point of care staff, it can cause a lot of confusion.” 

It’s also important for blinding purposes to keep an eye on how long it takes to prepare a treatment, she said. A study’s integrity, for example, could be violated if a complex investigational product takes an hour to equilibrate to room temperature and 20-30 minutes to prepare, while a placebo only requires “drawing a few mils of saline out of a bag and labeling it.”

Education for Patients Can Be Useful 

Hennes urged colleagues to remind patients to save investigational medication at the end of each cycle and return it to the clinic site for accountability.

She also suggested creating treatment calendars/reminders for patients and discussing adherence strategies with them. 

Hennes reported no disclosures. 

TOPLINE:

High-risk medications defined by the National Comprehensive Cancer Network (NCCN) and captured by the Geriatric Oncology Potentially Inappropriate Medication (GO-PIM) scale were prevalent in > one-third of veterans with solid and hematologic malignancies. Each additional GO-PIM was independently associated with higher risks for frailty at diagnosis, unplanned hospitalizations during follow-up, and death.

METHODOLOGY:

• Patients with cancer often use multiple chronic medications, raising risks for adverse events. Although several tools that identify PIMs have been developed that correlate with adverse cancer outcomes, their use is limited in busy oncology clinics. To improve implementation, researchers developed the GO-PIM scale using the NCCN’s list of high-risk medications.
• Researchers conducted a retrospective cohort study using data from the national Veterans Affairs Cancer Registry and electronic health records, which included 388,113 veterans newly diagnosed with solid or hematologic malignancies (median age, 69.3 years; 97.9% men; 76.1% non-Hispanic White and 17.3% Black individuals) between 2000 and 2022.
• They identified GO-PIMs using outpatient pharmacy records in the 90 days preceding cancer diagnosis. Each prescription for a specific GO-PIM was counted as one, including both individual drugs and drug classes listed in the GO-PIM scale.
• Study outcomes were frailty, hospitalizations, and overall survival. Baseline frailty at diagnosis was measured using the Veterans Affairs Frailty Index. The score ranged from 0 to 1, and higher scores indicated greater frailty. Patients were classified as nonfrail (score, ≤ 0.2), mildly frail (score, > 0.2 to 0.3), or moderate-to-severely frail (score, > 0.3).
• Lung (23.7%), prostate (21.5%), and gastrointestinal (20.5%) cancers were the most common, and the most frequent stages were IV (25.4%) and II (24.4%).

TAKEAWAY:

• Overall, 38.0% of veterans were prescribed ≥ 1 GO-PIMs at the time of cancer diagnosis, and the proportion increased to 56.1% among those with moderate-to-severe frailty.
• The most commonly prescribed classes of PIMs were selective serotonin reuptake inhibitors (SSRIs; 12.0%), opioids (10.4%), benzodiazepines (9.2%), and corticosteroids (9.2%). Among individual drugs, sertraline was the most common SSRI (4.3%), tramadol the most common opioid (5.3%), lorazepam the most common benzodiazepine (2.5%), and prednisone the most common corticosteroid (4.9%). Trends over time showed a steady increase in opioid prescriptions, peaking in 2014, followed by a subsequent decline, while prescriptions of benzodiazepines declined during the later years.
• After adjusting for age, cancer type and stage, and other covariates, each additional GO-PIM was associated with a 66% higher odds of mild or moderate-to-severe frailty at diagnosis (adjusted odds ratio, 1.66).
• After adjusting for frailty and covariates, each additional GO-PIM at diagnosis was associated with increased risks for unplanned hospitalizations and death (adjusted hazard ratios, 1.08 and 1.07, respectively). These associations remained stable in sensitivity analyses that restricted GO-PIMs to scheduled medications only, focused on patients who had initiated cancer treatment, and included only those aged ≥ 65 years.

IN PRACTICE:

“Whether prescribed for supportive oncology care or for coexisting medical conditions, high-risk medications identified as PIMs should be reviewed and optimized in patients with cancer,” the authors of the study wrote.

“GO-PIMs offers a streamlined, oncology-specific approach to identifying high-risk prescribing, and complements existing efforts to improve supportive care, especially for older, frail patients,” remarked Mostafa R. Mohamed, MBBCH, PhD, MSc, and Erika E. Ramsdale, MD, University of Rochester Medical Center, Rochester, New York in an invited commentary. “The next step lies in integrating tools such as GO-PIMs into everyday practice not only to flag high risk medications but also to support actionable changes in treatment planning and patient management, such as deprescribing,” they concluded.

SOURCE:

This study, led by Jennifer La, PhD, Harvard Medical School, Boston, was published online in Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

Prescription chronicity before or after follow-up was not measured and actual medication adherence could not be confirmed. Residual confounding by comorbidity could have existed, and the cross-sectional nature of linking GO-PIMs with frailty might have limited causal inference. Additionally, prescriptions were measured within Veterans Affairs pharmacy data, potentially underestimating GO-PIM prevalence, and the predominantly male population limited generalizability to gynecologic cancers.

DISCLOSURES:

This study was supported by grants and rewards from the Veterans Affairs Office of Research and Development, Cooperative Studies Program, National Institutes of Health, and American Heart Association. Some authors declared serving as consultants or receiving grants and having other ties with various sources. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

High-risk medications defined by the National Comprehensive Cancer Network (NCCN) and captured by the Geriatric Oncology Potentially Inappropriate Medication (GO-PIM) scale were prevalent in > one-third of veterans with solid and hematologic malignancies. Each additional GO-PIM was independently associated with higher risks for frailty at diagnosis, unplanned hospitalizations during follow-up, and death.

METHODOLOGY:

• Patients with cancer often use multiple chronic medications, raising risks for adverse events. Although several tools that identify PIMs have been developed that correlate with adverse cancer outcomes, their use is limited in busy oncology clinics. To improve implementation, researchers developed the GO-PIM scale using the NCCN’s list of high-risk medications.
• Researchers conducted a retrospective cohort study using data from the national Veterans Affairs Cancer Registry and electronic health records, which included 388,113 veterans newly diagnosed with solid or hematologic malignancies (median age, 69.3 years; 97.9% men; 76.1% non-Hispanic White and 17.3% Black individuals) between 2000 and 2022.
• They identified GO-PIMs using outpatient pharmacy records in the 90 days preceding cancer diagnosis. Each prescription for a specific GO-PIM was counted as one, including both individual drugs and drug classes listed in the GO-PIM scale.
• Study outcomes were frailty, hospitalizations, and overall survival. Baseline frailty at diagnosis was measured using the Veterans Affairs Frailty Index. The score ranged from 0 to 1, and higher scores indicated greater frailty. Patients were classified as nonfrail (score, ≤ 0.2), mildly frail (score, > 0.2 to 0.3), or moderate-to-severely frail (score, > 0.3).
• Lung (23.7%), prostate (21.5%), and gastrointestinal (20.5%) cancers were the most common, and the most frequent stages were IV (25.4%) and II (24.4%).

TAKEAWAY:

• Overall, 38.0% of veterans were prescribed ≥ 1 GO-PIMs at the time of cancer diagnosis, and the proportion increased to 56.1% among those with moderate-to-severe frailty.
• The most commonly prescribed classes of PIMs were selective serotonin reuptake inhibitors (SSRIs; 12.0%), opioids (10.4%), benzodiazepines (9.2%), and corticosteroids (9.2%). Among individual drugs, sertraline was the most common SSRI (4.3%), tramadol the most common opioid (5.3%), lorazepam the most common benzodiazepine (2.5%), and prednisone the most common corticosteroid (4.9%). Trends over time showed a steady increase in opioid prescriptions, peaking in 2014, followed by a subsequent decline, while prescriptions of benzodiazepines declined during the later years.
• After adjusting for age, cancer type and stage, and other covariates, each additional GO-PIM was associated with a 66% higher odds of mild or moderate-to-severe frailty at diagnosis (adjusted odds ratio, 1.66).
• After adjusting for frailty and covariates, each additional GO-PIM at diagnosis was associated with increased risks for unplanned hospitalizations and death (adjusted hazard ratios, 1.08 and 1.07, respectively). These associations remained stable in sensitivity analyses that restricted GO-PIMs to scheduled medications only, focused on patients who had initiated cancer treatment, and included only those aged ≥ 65 years.

IN PRACTICE:

“Whether prescribed for supportive oncology care or for coexisting medical conditions, high-risk medications identified as PIMs should be reviewed and optimized in patients with cancer,” the authors of the study wrote.

“GO-PIMs offers a streamlined, oncology-specific approach to identifying high-risk prescribing, and complements existing efforts to improve supportive care, especially for older, frail patients,” remarked Mostafa R. Mohamed, MBBCH, PhD, MSc, and Erika E. Ramsdale, MD, University of Rochester Medical Center, Rochester, New York in an invited commentary. “The next step lies in integrating tools such as GO-PIMs into everyday practice not only to flag high risk medications but also to support actionable changes in treatment planning and patient management, such as deprescribing,” they concluded.

SOURCE:

This study, led by Jennifer La, PhD, Harvard Medical School, Boston, was published online in Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

Prescription chronicity before or after follow-up was not measured and actual medication adherence could not be confirmed. Residual confounding by comorbidity could have existed, and the cross-sectional nature of linking GO-PIMs with frailty might have limited causal inference. Additionally, prescriptions were measured within Veterans Affairs pharmacy data, potentially underestimating GO-PIM prevalence, and the predominantly male population limited generalizability to gynecologic cancers.

DISCLOSURES:

This study was supported by grants and rewards from the Veterans Affairs Office of Research and Development, Cooperative Studies Program, National Institutes of Health, and American Heart Association. Some authors declared serving as consultants or receiving grants and having other ties with various sources. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

High-risk medications defined by the National Comprehensive Cancer Network (NCCN) and captured by the Geriatric Oncology Potentially Inappropriate Medication (GO-PIM) scale were prevalent in > one-third of veterans with solid and hematologic malignancies. Each additional GO-PIM was independently associated with higher risks for frailty at diagnosis, unplanned hospitalizations during follow-up, and death.

METHODOLOGY:

• Patients with cancer often use multiple chronic medications, raising risks for adverse events. Although several tools that identify PIMs have been developed that correlate with adverse cancer outcomes, their use is limited in busy oncology clinics. To improve implementation, researchers developed the GO-PIM scale using the NCCN’s list of high-risk medications.
• Researchers conducted a retrospective cohort study using data from the national Veterans Affairs Cancer Registry and electronic health records, which included 388,113 veterans newly diagnosed with solid or hematologic malignancies (median age, 69.3 years; 97.9% men; 76.1% non-Hispanic White and 17.3% Black individuals) between 2000 and 2022.
• They identified GO-PIMs using outpatient pharmacy records in the 90 days preceding cancer diagnosis. Each prescription for a specific GO-PIM was counted as one, including both individual drugs and drug classes listed in the GO-PIM scale.
• Study outcomes were frailty, hospitalizations, and overall survival. Baseline frailty at diagnosis was measured using the Veterans Affairs Frailty Index. The score ranged from 0 to 1, and higher scores indicated greater frailty. Patients were classified as nonfrail (score, ≤ 0.2), mildly frail (score, > 0.2 to 0.3), or moderate-to-severely frail (score, > 0.3).
• Lung (23.7%), prostate (21.5%), and gastrointestinal (20.5%) cancers were the most common, and the most frequent stages were IV (25.4%) and II (24.4%).

TAKEAWAY:

• Overall, 38.0% of veterans were prescribed ≥ 1 GO-PIMs at the time of cancer diagnosis, and the proportion increased to 56.1% among those with moderate-to-severe frailty.
• The most commonly prescribed classes of PIMs were selective serotonin reuptake inhibitors (SSRIs; 12.0%), opioids (10.4%), benzodiazepines (9.2%), and corticosteroids (9.2%). Among individual drugs, sertraline was the most common SSRI (4.3%), tramadol the most common opioid (5.3%), lorazepam the most common benzodiazepine (2.5%), and prednisone the most common corticosteroid (4.9%). Trends over time showed a steady increase in opioid prescriptions, peaking in 2014, followed by a subsequent decline, while prescriptions of benzodiazepines declined during the later years.
• After adjusting for age, cancer type and stage, and other covariates, each additional GO-PIM was associated with a 66% higher odds of mild or moderate-to-severe frailty at diagnosis (adjusted odds ratio, 1.66).
• After adjusting for frailty and covariates, each additional GO-PIM at diagnosis was associated with increased risks for unplanned hospitalizations and death (adjusted hazard ratios, 1.08 and 1.07, respectively). These associations remained stable in sensitivity analyses that restricted GO-PIMs to scheduled medications only, focused on patients who had initiated cancer treatment, and included only those aged ≥ 65 years.

IN PRACTICE:

“Whether prescribed for supportive oncology care or for coexisting medical conditions, high-risk medications identified as PIMs should be reviewed and optimized in patients with cancer,” the authors of the study wrote.

“GO-PIMs offers a streamlined, oncology-specific approach to identifying high-risk prescribing, and complements existing efforts to improve supportive care, especially for older, frail patients,” remarked Mostafa R. Mohamed, MBBCH, PhD, MSc, and Erika E. Ramsdale, MD, University of Rochester Medical Center, Rochester, New York in an invited commentary. “The next step lies in integrating tools such as GO-PIMs into everyday practice not only to flag high risk medications but also to support actionable changes in treatment planning and patient management, such as deprescribing,” they concluded.

SOURCE:

This study, led by Jennifer La, PhD, Harvard Medical School, Boston, was published online in Journal of the National Comprehensive Cancer Network.

LIMITATIONS:

Prescription chronicity before or after follow-up was not measured and actual medication adherence could not be confirmed. Residual confounding by comorbidity could have existed, and the cross-sectional nature of linking GO-PIMs with frailty might have limited causal inference. Additionally, prescriptions were measured within Veterans Affairs pharmacy data, potentially underestimating GO-PIM prevalence, and the predominantly male population limited generalizability to gynecologic cancers.

DISCLOSURES:

This study was supported by grants and rewards from the Veterans Affairs Office of Research and Development, Cooperative Studies Program, National Institutes of Health, and American Heart Association. Some authors declared serving as consultants or receiving grants and having other ties with various sources. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

About 1 in 10 veterans with early-stage cancer developed new persistent opioid use after curative‐intent surgery, though < 1% were diagnosed with opioid use disorder.

METHODOLOGY:

Although effective pain control during cancer treatment is vital, prescribing opioids in this context may contribute to unsafe, long-term use and related adverse outcomes. Veterans, who have higher-than-average rates of mental health and substance use disorders, may be at particular risk for adverse events from opioid use related to cancer treatment.

Researchers conducted a national retrospective cohort study of 9213 US veterans (98% men) with stage 0-III cancer who were opioid-naive and underwent curative-intent surgery at Veterans Affairs medical centers between 2015 and 2016. Prostate (n = 2594; 28%), colorectal (n = 2393; 26%), bladder (n = 2302; 25%), and lung (n = 1252; 14%) cancers were the most common.

Primary outcomes were the number of days of co-prescription of benzodiazepines and opioids (an indicator of unsafe opioid prescribing) and new persistent opioid use, defined as receiving ≥ 1 opioid prescription at 90-180 days postsurgery. Opioid‐related adverse effects, including opioid use disorder and opioid overdose, were also reported.

Overall, 6970 (76%) of the participants were prescribed opioids at some point during the baseline treatment period (30 days before through 14 days after surgery). The mean morphine milligram equivalent (MME) was 172.5.

 

TAKEAWAY:

Overall, 4% of patients received co-prescriptions of benzodiazepines and opioids. The mean number of days of coprescription rose in tandem with opioid doses during the treatment period: from 0.48 days in the lowest MME quartile to 2.1 days in the highest quartile (P < .0001).

Over 1 in 10 patients (10.6%) developed new persistent opioid use. Those in the highest MME quartile had a 1.6-fold greater risk of developing new persistent opioid use than those with no opioid exposure during the treatment period (hazard ratio [HR], 1.6; P < .001). The percentage of patients with opioid prescriptions did decline over the 13-month follow-up, but among those who continued on opioids, the daily MME remained stable (median, 20 for month 1 and 30 for month 12).

Treatment with adjuvant chemotherapy increased the risk for new persistent opioid use (HR, 1.5; 95% CI, 1.2-1.8; P < .001). Additional risk factors included having bladder, colorectal, lung, or other types of cancer (vs prostate cancer); stage I-III disease (vs stage 0); age 45-64 years (vs older); lower socioeconomic status; preoperative use of nonopioid pain medication; and a baseline history of anxiety, depression, or posttraumatic stress disorder.

Over 13 months, 72 patients (0.78%) developed opioid use disorder, 3 (0.03%) experienced nonoverdose adverse events, and no opioid overdose occurred.

 

IN PRACTICE:

“Although a cancer diagnosis, treatment, and associated pain syndromes will require specific pain management strategies,” the authors wrote, “efforts should be taken to mitigate long‐term opioid use and its potential adverse effects in this population. They added that “both system‐level changes that involve preoperative evaluation planning as well as increased knowledge, awareness, and education among providers and patients about the risk of long‐term opioid use can guide strategies for effective and safe pain management.”

SOURCE:

The study, led by Marilyn M. Schapira, MD, MPH, Center for Healthcare Evaluation, Research, and Promotion, Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, was published online in Cancer.

LIMITATIONS:

Opioid prescriptions outside the Veterans Affairs system were not captured. The study was based on filled opioid prescriptions, and actual patient consumption was unknown. Outpatient methadone prescriptions were not included. The study also excluded patients with breast cancer, limiting generalizability.

DISCLOSURES:

The study was funded by grant from the Department of Veterans Affairs. One author reported consulting for Moderna and TriNetX. Another author reported consulting for Genetic Chemistry, Thyme Care, Biofourmis, Onc.Al, Credit Suisse, Main Street Health, ConcertAI, Medscape, and G1 Therapeutics. The other authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

About 1 in 10 veterans with early-stage cancer developed new persistent opioid use after curative‐intent surgery, though < 1% were diagnosed with opioid use disorder.

METHODOLOGY:

Although effective pain control during cancer treatment is vital, prescribing opioids in this context may contribute to unsafe, long-term use and related adverse outcomes. Veterans, who have higher-than-average rates of mental health and substance use disorders, may be at particular risk for adverse events from opioid use related to cancer treatment.

Researchers conducted a national retrospective cohort study of 9213 US veterans (98% men) with stage 0-III cancer who were opioid-naive and underwent curative-intent surgery at Veterans Affairs medical centers between 2015 and 2016. Prostate (n = 2594; 28%), colorectal (n = 2393; 26%), bladder (n = 2302; 25%), and lung (n = 1252; 14%) cancers were the most common.

Primary outcomes were the number of days of co-prescription of benzodiazepines and opioids (an indicator of unsafe opioid prescribing) and new persistent opioid use, defined as receiving ≥ 1 opioid prescription at 90-180 days postsurgery. Opioid‐related adverse effects, including opioid use disorder and opioid overdose, were also reported.

Overall, 6970 (76%) of the participants were prescribed opioids at some point during the baseline treatment period (30 days before through 14 days after surgery). The mean morphine milligram equivalent (MME) was 172.5.

 

TAKEAWAY:

Overall, 4% of patients received co-prescriptions of benzodiazepines and opioids. The mean number of days of coprescription rose in tandem with opioid doses during the treatment period: from 0.48 days in the lowest MME quartile to 2.1 days in the highest quartile (P < .0001).

Over 1 in 10 patients (10.6%) developed new persistent opioid use. Those in the highest MME quartile had a 1.6-fold greater risk of developing new persistent opioid use than those with no opioid exposure during the treatment period (hazard ratio [HR], 1.6; P < .001). The percentage of patients with opioid prescriptions did decline over the 13-month follow-up, but among those who continued on opioids, the daily MME remained stable (median, 20 for month 1 and 30 for month 12).

Treatment with adjuvant chemotherapy increased the risk for new persistent opioid use (HR, 1.5; 95% CI, 1.2-1.8; P < .001). Additional risk factors included having bladder, colorectal, lung, or other types of cancer (vs prostate cancer); stage I-III disease (vs stage 0); age 45-64 years (vs older); lower socioeconomic status; preoperative use of nonopioid pain medication; and a baseline history of anxiety, depression, or posttraumatic stress disorder.

Over 13 months, 72 patients (0.78%) developed opioid use disorder, 3 (0.03%) experienced nonoverdose adverse events, and no opioid overdose occurred.

 

IN PRACTICE:

“Although a cancer diagnosis, treatment, and associated pain syndromes will require specific pain management strategies,” the authors wrote, “efforts should be taken to mitigate long‐term opioid use and its potential adverse effects in this population. They added that “both system‐level changes that involve preoperative evaluation planning as well as increased knowledge, awareness, and education among providers and patients about the risk of long‐term opioid use can guide strategies for effective and safe pain management.”

SOURCE:

The study, led by Marilyn M. Schapira, MD, MPH, Center for Healthcare Evaluation, Research, and Promotion, Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, was published online in Cancer.

LIMITATIONS:

Opioid prescriptions outside the Veterans Affairs system were not captured. The study was based on filled opioid prescriptions, and actual patient consumption was unknown. Outpatient methadone prescriptions were not included. The study also excluded patients with breast cancer, limiting generalizability.

DISCLOSURES:

The study was funded by grant from the Department of Veterans Affairs. One author reported consulting for Moderna and TriNetX. Another author reported consulting for Genetic Chemistry, Thyme Care, Biofourmis, Onc.Al, Credit Suisse, Main Street Health, ConcertAI, Medscape, and G1 Therapeutics. The other authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

About 1 in 10 veterans with early-stage cancer developed new persistent opioid use after curative‐intent surgery, though < 1% were diagnosed with opioid use disorder.

METHODOLOGY:

Although effective pain control during cancer treatment is vital, prescribing opioids in this context may contribute to unsafe, long-term use and related adverse outcomes. Veterans, who have higher-than-average rates of mental health and substance use disorders, may be at particular risk for adverse events from opioid use related to cancer treatment.

Researchers conducted a national retrospective cohort study of 9213 US veterans (98% men) with stage 0-III cancer who were opioid-naive and underwent curative-intent surgery at Veterans Affairs medical centers between 2015 and 2016. Prostate (n = 2594; 28%), colorectal (n = 2393; 26%), bladder (n = 2302; 25%), and lung (n = 1252; 14%) cancers were the most common.

Primary outcomes were the number of days of co-prescription of benzodiazepines and opioids (an indicator of unsafe opioid prescribing) and new persistent opioid use, defined as receiving ≥ 1 opioid prescription at 90-180 days postsurgery. Opioid‐related adverse effects, including opioid use disorder and opioid overdose, were also reported.

Overall, 6970 (76%) of the participants were prescribed opioids at some point during the baseline treatment period (30 days before through 14 days after surgery). The mean morphine milligram equivalent (MME) was 172.5.

 

TAKEAWAY:

Overall, 4% of patients received co-prescriptions of benzodiazepines and opioids. The mean number of days of coprescription rose in tandem with opioid doses during the treatment period: from 0.48 days in the lowest MME quartile to 2.1 days in the highest quartile (P < .0001).

Over 1 in 10 patients (10.6%) developed new persistent opioid use. Those in the highest MME quartile had a 1.6-fold greater risk of developing new persistent opioid use than those with no opioid exposure during the treatment period (hazard ratio [HR], 1.6; P < .001). The percentage of patients with opioid prescriptions did decline over the 13-month follow-up, but among those who continued on opioids, the daily MME remained stable (median, 20 for month 1 and 30 for month 12).

Treatment with adjuvant chemotherapy increased the risk for new persistent opioid use (HR, 1.5; 95% CI, 1.2-1.8; P < .001). Additional risk factors included having bladder, colorectal, lung, or other types of cancer (vs prostate cancer); stage I-III disease (vs stage 0); age 45-64 years (vs older); lower socioeconomic status; preoperative use of nonopioid pain medication; and a baseline history of anxiety, depression, or posttraumatic stress disorder.

Over 13 months, 72 patients (0.78%) developed opioid use disorder, 3 (0.03%) experienced nonoverdose adverse events, and no opioid overdose occurred.

 

IN PRACTICE:

“Although a cancer diagnosis, treatment, and associated pain syndromes will require specific pain management strategies,” the authors wrote, “efforts should be taken to mitigate long‐term opioid use and its potential adverse effects in this population. They added that “both system‐level changes that involve preoperative evaluation planning as well as increased knowledge, awareness, and education among providers and patients about the risk of long‐term opioid use can guide strategies for effective and safe pain management.”

SOURCE:

The study, led by Marilyn M. Schapira, MD, MPH, Center for Healthcare Evaluation, Research, and Promotion, Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, was published online in Cancer.

LIMITATIONS:

Opioid prescriptions outside the Veterans Affairs system were not captured. The study was based on filled opioid prescriptions, and actual patient consumption was unknown. Outpatient methadone prescriptions were not included. The study also excluded patients with breast cancer, limiting generalizability.

DISCLOSURES:

The study was funded by grant from the Department of Veterans Affairs. One author reported consulting for Moderna and TriNetX. Another author reported consulting for Genetic Chemistry, Thyme Care, Biofourmis, Onc.Al, Credit Suisse, Main Street Health, ConcertAI, Medscape, and G1 Therapeutics. The other authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Bariatric surgery was associated with higher short-term risks for acute kidney injury (AKI) and nephrolithiasis but lower long-term risks for chronic kidney disease (CKD) and kidney failure with replacement therapy (KFRT), according to a population-based study in Denmark.

Writing in BMC Nephrology, researchers reported patients with bariatric surgery had an increased 1-year risk for AKI and 10-year risk for nephrolithiasis, alongside a decreased 10-year risk for CKD (stages G3-5) and KFRT, compared with matched patients diagnosed with overweight/obesity who did not undergo surgery.

 

A Closer Look

Using national registry data, the team identified all adults who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) between January 1, 2006, and December 31, 2018. Each patient was age- and sex-matched (1:5) to patients with hospital-diagnosed overweight/obesity without bariatric surgery. Researchers also compared results against a population cohort matched solely by age and sex. Outcomes included cumulative risks for AKI, nephrolithiasis, CKD (G3-G5), and KFRT.

The cohort comprised 18,827 surgical patients (17,200 RYGB and 1627 SG) and 94,135 matched comparators. Median age was 41 years, 76% were women, and the median follow-up was 8.1 years. At baseline, the median estimated glomerular filtration rate (eGFR) was comparable (103 mL/min/1.73 m2) between both surgery and overweight/obesity control groups, as were A1c levels. There were fewer comorbidities in the population cohort matched only by age and sex than in the overweight/obesity comparison cohort.

Using multivariable Cox regression analyses, the researchers found the 1-year risk for AKI following bariatric surgery was 2.7%. At 10 years, risks were 3.5% for nephrolithiasis, 0.4% for CKD, and 0.2% for KFRT.

Adjusted hazard ratios (HRs) after bariatric surgery vs without bariatric surgery were higher for AKI (HR, 1.63) and nephrolithiasis (HR, 1.73) and lower for CKD (HR, 0.41) and KFRT (HR, 0.63). Results were consistent when compared against the population cohort.

By procedure, the 1-year AKI risk was 2.7% after RYGB and 2.4% after SG vs 2.5% in the overweight/obesity cohort and 1.1% in the population cohort. At 10 years, the risk for incident nephrolithiasis was 3.6% after RYGB and 1.2% after SG vs 2.4% and 1.3% in the overweight/obese and population cohorts, respectively. KFRT risk at 10 years was 0.2% after RYGB and 1.6% after SG vs 0.4% and 0.1% in the overweight/obesity and population cohorts, respectively. 

“The increased short-term risk of AKI and nephrolithiasis was expected, given the physiological changes after bariatric surgery, but the long-term reduction in CKD and KFRT was both encouraging and clinically important,” said study investigator Christian Goul Sørensen, MD, Department of Clinical Epidemiology, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Aarhus, Denmark. “It was also noteworthy that the results were consistent not only in the obesity-matched comparison cohort but also in the cohort matched solely on age and sex, which further strengthens the validity of our findings.”

RYGB and SG are known to help mitigate obesity-associated complications, such as hypertension, hyperlipidemia, and type 2 diabetes. Studies have suggested that there are improvements in eGFR after bariatric surgery. However, long-term evidence from routine clinical care has not been well studied. Furthermore, RYGB may lead to AKI due to a combination of preoperative, intraoperative, and postoperative factors.

“Obesity is a major driver of kidney disease, often in combination with comorbidities such as diabetes and hypertension,” Sorensen told GI & Hepatology News. “Patients and clinicians face complex decisions about surgery, and understanding both the short-term surgical risks and the long-term kidney benefits is crucial for informed counseling. As bariatric surgery becomes increasingly common worldwide, population-based evidence like this helps guide clinical practice and supports shared decision-making with patients.”

 

Consistent With Clinical Experience

Panduranga S. Rao, MD, professor of nephrology at the University of Michigan, Ann Arbor, Michigan, who was not involved in the study, called the results consistent with prior clinical experience. He highlighted the strong follow-up and detailed lab and comorbidity data, while noting that the decreasing use of RYGB may limit applicability going forward.

“However, one has to remain vigilant to the risk of nephrolithiasis in the patients who have undergone Roux-en-Y in the past,” he said.

The observation of decreasing risk for CKD with weight loss is particularly relevant, given the growing use of GLP-1s for weight loss, Rao added.

Srinivasan Beddhu, MD, professor of internal medicine and the scientific director of the Cardio-Renal & Metabolism Center at the University of Utah Health in Salt Lake City, said the large national cohort design and outcomes data offer further reassurance about the long-term kidney health effects of bariatric surgery.

“The message that the risks of AKI and nephrolithiasis are outweighed by the long-term kidney protective effects of bariatric surgery is important,” said Beddhu.

Alexander Chang, MD, associate professor and a practicing nephrologist at the Geisinger Health System in Danville, Pennsylvania, noted that the study provided more evidence about RYGB-associated kidney stone risk via fat malabsorption, which raises the levels of fatty acids that bind dietary calcium.

“Calcium normally precipitates with dietary oxalate, and thus, there can be an increase in urinary oxalate,” Chang explained. “There did not appear to be increased risk of nephrolithiasis with sleeve gastrectomy, consistent with other studies.

“This study emphasizes the importance of multidisciplinary care post-bariatric surgery to try to prevent complications such as kidney stones,” Chang added. “This can be tricky but requires trying different strategies to increase fluid intake and calcium citrate supplements with meals.”

The study was partly funded by a grant from the Novo Nordisk Foundation and the Independent Research Fund Denmark. One author reported receiving a speaking fee support from Novo Nordisk for conference attendance. The other authors declared no competing interests. Sørensen, Rao, Beddhu, and Chang had no financial disclosures.

 

A version of this article appeared on Medscape.com.

Bariatric surgery was associated with higher short-term risks for acute kidney injury (AKI) and nephrolithiasis but lower long-term risks for chronic kidney disease (CKD) and kidney failure with replacement therapy (KFRT), according to a population-based study in Denmark.

Writing in BMC Nephrology, researchers reported patients with bariatric surgery had an increased 1-year risk for AKI and 10-year risk for nephrolithiasis, alongside a decreased 10-year risk for CKD (stages G3-5) and KFRT, compared with matched patients diagnosed with overweight/obesity who did not undergo surgery.

 

A Closer Look

Using national registry data, the team identified all adults who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) between January 1, 2006, and December 31, 2018. Each patient was age- and sex-matched (1:5) to patients with hospital-diagnosed overweight/obesity without bariatric surgery. Researchers also compared results against a population cohort matched solely by age and sex. Outcomes included cumulative risks for AKI, nephrolithiasis, CKD (G3-G5), and KFRT.

The cohort comprised 18,827 surgical patients (17,200 RYGB and 1627 SG) and 94,135 matched comparators. Median age was 41 years, 76% were women, and the median follow-up was 8.1 years. At baseline, the median estimated glomerular filtration rate (eGFR) was comparable (103 mL/min/1.73 m2) between both surgery and overweight/obesity control groups, as were A1c levels. There were fewer comorbidities in the population cohort matched only by age and sex than in the overweight/obesity comparison cohort.

Using multivariable Cox regression analyses, the researchers found the 1-year risk for AKI following bariatric surgery was 2.7%. At 10 years, risks were 3.5% for nephrolithiasis, 0.4% for CKD, and 0.2% for KFRT.

Adjusted hazard ratios (HRs) after bariatric surgery vs without bariatric surgery were higher for AKI (HR, 1.63) and nephrolithiasis (HR, 1.73) and lower for CKD (HR, 0.41) and KFRT (HR, 0.63). Results were consistent when compared against the population cohort.

By procedure, the 1-year AKI risk was 2.7% after RYGB and 2.4% after SG vs 2.5% in the overweight/obesity cohort and 1.1% in the population cohort. At 10 years, the risk for incident nephrolithiasis was 3.6% after RYGB and 1.2% after SG vs 2.4% and 1.3% in the overweight/obese and population cohorts, respectively. KFRT risk at 10 years was 0.2% after RYGB and 1.6% after SG vs 0.4% and 0.1% in the overweight/obesity and population cohorts, respectively. 

“The increased short-term risk of AKI and nephrolithiasis was expected, given the physiological changes after bariatric surgery, but the long-term reduction in CKD and KFRT was both encouraging and clinically important,” said study investigator Christian Goul Sørensen, MD, Department of Clinical Epidemiology, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Aarhus, Denmark. “It was also noteworthy that the results were consistent not only in the obesity-matched comparison cohort but also in the cohort matched solely on age and sex, which further strengthens the validity of our findings.”

RYGB and SG are known to help mitigate obesity-associated complications, such as hypertension, hyperlipidemia, and type 2 diabetes. Studies have suggested that there are improvements in eGFR after bariatric surgery. However, long-term evidence from routine clinical care has not been well studied. Furthermore, RYGB may lead to AKI due to a combination of preoperative, intraoperative, and postoperative factors.

“Obesity is a major driver of kidney disease, often in combination with comorbidities such as diabetes and hypertension,” Sorensen told GI & Hepatology News. “Patients and clinicians face complex decisions about surgery, and understanding both the short-term surgical risks and the long-term kidney benefits is crucial for informed counseling. As bariatric surgery becomes increasingly common worldwide, population-based evidence like this helps guide clinical practice and supports shared decision-making with patients.”

 

Consistent With Clinical Experience

Panduranga S. Rao, MD, professor of nephrology at the University of Michigan, Ann Arbor, Michigan, who was not involved in the study, called the results consistent with prior clinical experience. He highlighted the strong follow-up and detailed lab and comorbidity data, while noting that the decreasing use of RYGB may limit applicability going forward.

“However, one has to remain vigilant to the risk of nephrolithiasis in the patients who have undergone Roux-en-Y in the past,” he said.

The observation of decreasing risk for CKD with weight loss is particularly relevant, given the growing use of GLP-1s for weight loss, Rao added.

Srinivasan Beddhu, MD, professor of internal medicine and the scientific director of the Cardio-Renal & Metabolism Center at the University of Utah Health in Salt Lake City, said the large national cohort design and outcomes data offer further reassurance about the long-term kidney health effects of bariatric surgery.

“The message that the risks of AKI and nephrolithiasis are outweighed by the long-term kidney protective effects of bariatric surgery is important,” said Beddhu.

Alexander Chang, MD, associate professor and a practicing nephrologist at the Geisinger Health System in Danville, Pennsylvania, noted that the study provided more evidence about RYGB-associated kidney stone risk via fat malabsorption, which raises the levels of fatty acids that bind dietary calcium.

“Calcium normally precipitates with dietary oxalate, and thus, there can be an increase in urinary oxalate,” Chang explained. “There did not appear to be increased risk of nephrolithiasis with sleeve gastrectomy, consistent with other studies.

“This study emphasizes the importance of multidisciplinary care post-bariatric surgery to try to prevent complications such as kidney stones,” Chang added. “This can be tricky but requires trying different strategies to increase fluid intake and calcium citrate supplements with meals.”

The study was partly funded by a grant from the Novo Nordisk Foundation and the Independent Research Fund Denmark. One author reported receiving a speaking fee support from Novo Nordisk for conference attendance. The other authors declared no competing interests. Sørensen, Rao, Beddhu, and Chang had no financial disclosures.

 

A version of this article appeared on Medscape.com.

Bariatric surgery was associated with higher short-term risks for acute kidney injury (AKI) and nephrolithiasis but lower long-term risks for chronic kidney disease (CKD) and kidney failure with replacement therapy (KFRT), according to a population-based study in Denmark.

Writing in BMC Nephrology, researchers reported patients with bariatric surgery had an increased 1-year risk for AKI and 10-year risk for nephrolithiasis, alongside a decreased 10-year risk for CKD (stages G3-5) and KFRT, compared with matched patients diagnosed with overweight/obesity who did not undergo surgery.

 

A Closer Look

Using national registry data, the team identified all adults who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) between January 1, 2006, and December 31, 2018. Each patient was age- and sex-matched (1:5) to patients with hospital-diagnosed overweight/obesity without bariatric surgery. Researchers also compared results against a population cohort matched solely by age and sex. Outcomes included cumulative risks for AKI, nephrolithiasis, CKD (G3-G5), and KFRT.

The cohort comprised 18,827 surgical patients (17,200 RYGB and 1627 SG) and 94,135 matched comparators. Median age was 41 years, 76% were women, and the median follow-up was 8.1 years. At baseline, the median estimated glomerular filtration rate (eGFR) was comparable (103 mL/min/1.73 m2) between both surgery and overweight/obesity control groups, as were A1c levels. There were fewer comorbidities in the population cohort matched only by age and sex than in the overweight/obesity comparison cohort.

Using multivariable Cox regression analyses, the researchers found the 1-year risk for AKI following bariatric surgery was 2.7%. At 10 years, risks were 3.5% for nephrolithiasis, 0.4% for CKD, and 0.2% for KFRT.

Adjusted hazard ratios (HRs) after bariatric surgery vs without bariatric surgery were higher for AKI (HR, 1.63) and nephrolithiasis (HR, 1.73) and lower for CKD (HR, 0.41) and KFRT (HR, 0.63). Results were consistent when compared against the population cohort.

By procedure, the 1-year AKI risk was 2.7% after RYGB and 2.4% after SG vs 2.5% in the overweight/obesity cohort and 1.1% in the population cohort. At 10 years, the risk for incident nephrolithiasis was 3.6% after RYGB and 1.2% after SG vs 2.4% and 1.3% in the overweight/obese and population cohorts, respectively. KFRT risk at 10 years was 0.2% after RYGB and 1.6% after SG vs 0.4% and 0.1% in the overweight/obesity and population cohorts, respectively. 

“The increased short-term risk of AKI and nephrolithiasis was expected, given the physiological changes after bariatric surgery, but the long-term reduction in CKD and KFRT was both encouraging and clinically important,” said study investigator Christian Goul Sørensen, MD, Department of Clinical Epidemiology, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Aarhus, Denmark. “It was also noteworthy that the results were consistent not only in the obesity-matched comparison cohort but also in the cohort matched solely on age and sex, which further strengthens the validity of our findings.”

RYGB and SG are known to help mitigate obesity-associated complications, such as hypertension, hyperlipidemia, and type 2 diabetes. Studies have suggested that there are improvements in eGFR after bariatric surgery. However, long-term evidence from routine clinical care has not been well studied. Furthermore, RYGB may lead to AKI due to a combination of preoperative, intraoperative, and postoperative factors.

“Obesity is a major driver of kidney disease, often in combination with comorbidities such as diabetes and hypertension,” Sorensen told GI & Hepatology News. “Patients and clinicians face complex decisions about surgery, and understanding both the short-term surgical risks and the long-term kidney benefits is crucial for informed counseling. As bariatric surgery becomes increasingly common worldwide, population-based evidence like this helps guide clinical practice and supports shared decision-making with patients.”

 

Consistent With Clinical Experience

Panduranga S. Rao, MD, professor of nephrology at the University of Michigan, Ann Arbor, Michigan, who was not involved in the study, called the results consistent with prior clinical experience. He highlighted the strong follow-up and detailed lab and comorbidity data, while noting that the decreasing use of RYGB may limit applicability going forward.

“However, one has to remain vigilant to the risk of nephrolithiasis in the patients who have undergone Roux-en-Y in the past,” he said.

The observation of decreasing risk for CKD with weight loss is particularly relevant, given the growing use of GLP-1s for weight loss, Rao added.

Srinivasan Beddhu, MD, professor of internal medicine and the scientific director of the Cardio-Renal & Metabolism Center at the University of Utah Health in Salt Lake City, said the large national cohort design and outcomes data offer further reassurance about the long-term kidney health effects of bariatric surgery.

“The message that the risks of AKI and nephrolithiasis are outweighed by the long-term kidney protective effects of bariatric surgery is important,” said Beddhu.

Alexander Chang, MD, associate professor and a practicing nephrologist at the Geisinger Health System in Danville, Pennsylvania, noted that the study provided more evidence about RYGB-associated kidney stone risk via fat malabsorption, which raises the levels of fatty acids that bind dietary calcium.

“Calcium normally precipitates with dietary oxalate, and thus, there can be an increase in urinary oxalate,” Chang explained. “There did not appear to be increased risk of nephrolithiasis with sleeve gastrectomy, consistent with other studies.

“This study emphasizes the importance of multidisciplinary care post-bariatric surgery to try to prevent complications such as kidney stones,” Chang added. “This can be tricky but requires trying different strategies to increase fluid intake and calcium citrate supplements with meals.”

The study was partly funded by a grant from the Novo Nordisk Foundation and the Independent Research Fund Denmark. One author reported receiving a speaking fee support from Novo Nordisk for conference attendance. The other authors declared no competing interests. Sørensen, Rao, Beddhu, and Chang had no financial disclosures.

 

A version of this article appeared on Medscape.com.