Federal Practitioner

Inhaling a pleasant aroma during sleep has been linked to a “dramatic” improvement in memory, early research suggests.

In a small, randomized controlled trial researchers found that when cognitively normal individuals were exposed to the scent of an essential oil for 2 hours every night over 6 months, they experienced a 226% improvement in memory compared with a control group who received only a trace amount of the diffused scent.

In addition, functional magnetic resonance imaging (fMRI) showed that those in the enriched group had improved functioning of the left uncinate fasciculus, an area of the brain linked to memory and cognition, which typically declines with age.

“To my knowledge, that level of [memory] improvement is far greater than anything that has been reported for healthy older adults and we also found a critical memory pathway in their brains improved to a similar extent relative to unenriched older adults,” senior investigator Michael Leon, PhD, professor emeritus, University of California, Irvine, said in an interview.

The study was published online in Frontiers of Neuroscience.
 

The brain’s “superhighway”

Olfactory enrichment “involves the daily exposure of individuals to multiple odorants” and has been shown in mouse models to improve memory and neurogenesis, the investigators noted.

A previous study showed that exposure to individual essential oils for 30 minutes a day over 3 months induced neurogenesis in the olfactory bulb and the hippocampus.

“The olfactory system is the only sense that has a direct ‘superhighway’ input to the memory centers areas of the brain; all the other senses have to reach those brain areas through what you might call the ‘side streets’ of the brain, and so consequently, they have much less impact on maintaining the health of those memory centers.”

When olfaction is compromised, “the memory centers of the brain start to deteriorate and, conversely, when people are given olfactory enrichment, their memory areas become larger and more functional,” he added.

Olfactory dysfunction is the first symptom of Alzheimer’s disease (AD) and is also found in virtually all neurological and psychiatric disorders.

“I’ve counted 68 of them – including anorexia, anxiety, [attention-deficit/hyperactivity disorder], depression, epilepsy, and stroke. In fact, by mid-life, your all-cause mortality can be predicted by your ability to smell things,” Dr. Leon said.

Dr. Leon and colleagues previously developed an effective treatment for autism using environmental enrichment that focused on odor stimulation, along with stimulating other senses. “We then considered the possibility that olfactory enrichment alone might improve brain function.”
 

Rose, orange, eucalyptus …

For the study, the researchers randomly assigned 43 older adults, aged 60-85 years, to receive either nightly exposure to essential oil scents delivered via a diffuser (n = 20; mean [SD] age, 70.1 [6.6] years) or to a sham control with only trace amounts of odorants (n = 23; mean age, 69.2 [7.1] years) for a period of 6 months.

The intervention group was exposed to a single odorant, delivered through a diffuser, for 2 hours nightly, rotating through seven pleasant aromas each week. They included rose, orange, eucalyptus, lemon, peppermint, rosemary, and lavender scents.

All participants completed a battery of tests at baseline, including the Mini-Mental State Examination (MMSE), which confirmed normal cognitive functioning. At baseline and after a 6-month follow-up, participants completed the Rey Auditory Verbal Learning Test (RAVLT) as well as three subsets of the Wechsler Adult Intelligence Scale–Third Edition (WAIS-III).

Olfactory system function was assessed using “Sniffin Sticks,” allowing the researchers to determine if olfactory enrichment enhanced olfactory performance.

Participants underwent fMRI at baseline and again at 6 months.

Brain imaging results showed a “clear, statistically significant 226% difference between enriched and control older adults in performance on the RAVLT, which evaluates learning and memory (timepoint × group interaction; F = 6.63; P = .02; Cohen’s d = 1.08; a “large effect size”).

They also found a significant change in the mean diffusivity of the left uncinate fasciculus in the enriched group compared with the controls (timepoint × group interaction; F = 4.39; P = .043; h 2 p = .101; a “medium-size effect”).

The uncinate fasciculus is a “major pathway” connecting the basolateral amygdala and the entorhinal cortex to the prefrontal cortex. This pathway deteriorates in aging and in AD and “has been suggested to play a role in mediating episodic memory, language, socio-emotional processing, and selecting among competing memories during retrieval.”

No significant differences were found between the groups in olfactory ability.

Limitations of the study include its small sample size. The investigators hope the findings will “stimulate larger scale clinical trials systematically testing the therapeutic efficacy of olfactory enrichment in treating memory loss in older adults.”
 

Exciting but preliminary

Commenting for this article, Donald Wilson, PhD, professor of child and adolescent psychiatry and of neuroscience and physiology, the Child Study Center, NYU Langone Medical Center, New York, said that multiple studies have “demonstrated that problems with sense of smell are associated with and sometimes can precede other symptoms for many disorders, including AD, Parkinson’s disease, and depression.”

Recent work has suggested that this relationship can be “bidirectional” – for example, losing one’s sense of smell might promote depression, while depressive disorder might lead to impaired smell, according to Dr. Wilson, also director and senior research scientist, the Emotional Brain Institute, Nathan Kline Institute for Psychiatric Research. He was not involved with the study.

This “two-way interaction” may raise the possibility that “improving olfaction could impact nonolfactory disorders.”

This paper “brings together” previous research findings to show that odors during bedtime can improve some aspects of cognitive function and circuits that are known to be important for memory and cognition – which Dr. Wilson called “a very exciting, though relatively preliminary, finding.”

A caveat is that several measures of cognitive function were assessed and only one (verbal memory) showed clear improvement.

Nevertheless, there’s “very strong interest now in the olfactory and nonolfactory aspects of odor training and this training expands the training possibilities to sleep. This could be a powerful tool for cognitive improvement and/or rescue if follow-up studies support these findings,” Dr. Wilson said.

A version of this article appeared on Medscape.com.

Inhaling a pleasant aroma during sleep has been linked to a “dramatic” improvement in memory, early research suggests.

In a small, randomized controlled trial researchers found that when cognitively normal individuals were exposed to the scent of an essential oil for 2 hours every night over 6 months, they experienced a 226% improvement in memory compared with a control group who received only a trace amount of the diffused scent.

In addition, functional magnetic resonance imaging (fMRI) showed that those in the enriched group had improved functioning of the left uncinate fasciculus, an area of the brain linked to memory and cognition, which typically declines with age.

“To my knowledge, that level of [memory] improvement is far greater than anything that has been reported for healthy older adults and we also found a critical memory pathway in their brains improved to a similar extent relative to unenriched older adults,” senior investigator Michael Leon, PhD, professor emeritus, University of California, Irvine, said in an interview.

The study was published online in Frontiers of Neuroscience.
 

The brain’s “superhighway”

Olfactory enrichment “involves the daily exposure of individuals to multiple odorants” and has been shown in mouse models to improve memory and neurogenesis, the investigators noted.

A previous study showed that exposure to individual essential oils for 30 minutes a day over 3 months induced neurogenesis in the olfactory bulb and the hippocampus.

“The olfactory system is the only sense that has a direct ‘superhighway’ input to the memory centers areas of the brain; all the other senses have to reach those brain areas through what you might call the ‘side streets’ of the brain, and so consequently, they have much less impact on maintaining the health of those memory centers.”

When olfaction is compromised, “the memory centers of the brain start to deteriorate and, conversely, when people are given olfactory enrichment, their memory areas become larger and more functional,” he added.

Olfactory dysfunction is the first symptom of Alzheimer’s disease (AD) and is also found in virtually all neurological and psychiatric disorders.

“I’ve counted 68 of them – including anorexia, anxiety, [attention-deficit/hyperactivity disorder], depression, epilepsy, and stroke. In fact, by mid-life, your all-cause mortality can be predicted by your ability to smell things,” Dr. Leon said.

Dr. Leon and colleagues previously developed an effective treatment for autism using environmental enrichment that focused on odor stimulation, along with stimulating other senses. “We then considered the possibility that olfactory enrichment alone might improve brain function.”
 

Rose, orange, eucalyptus …

For the study, the researchers randomly assigned 43 older adults, aged 60-85 years, to receive either nightly exposure to essential oil scents delivered via a diffuser (n = 20; mean [SD] age, 70.1 [6.6] years) or to a sham control with only trace amounts of odorants (n = 23; mean age, 69.2 [7.1] years) for a period of 6 months.

The intervention group was exposed to a single odorant, delivered through a diffuser, for 2 hours nightly, rotating through seven pleasant aromas each week. They included rose, orange, eucalyptus, lemon, peppermint, rosemary, and lavender scents.

All participants completed a battery of tests at baseline, including the Mini-Mental State Examination (MMSE), which confirmed normal cognitive functioning. At baseline and after a 6-month follow-up, participants completed the Rey Auditory Verbal Learning Test (RAVLT) as well as three subsets of the Wechsler Adult Intelligence Scale–Third Edition (WAIS-III).

Olfactory system function was assessed using “Sniffin Sticks,” allowing the researchers to determine if olfactory enrichment enhanced olfactory performance.

Participants underwent fMRI at baseline and again at 6 months.

Brain imaging results showed a “clear, statistically significant 226% difference between enriched and control older adults in performance on the RAVLT, which evaluates learning and memory (timepoint × group interaction; F = 6.63; P = .02; Cohen’s d = 1.08; a “large effect size”).

They also found a significant change in the mean diffusivity of the left uncinate fasciculus in the enriched group compared with the controls (timepoint × group interaction; F = 4.39; P = .043; h 2 p = .101; a “medium-size effect”).

The uncinate fasciculus is a “major pathway” connecting the basolateral amygdala and the entorhinal cortex to the prefrontal cortex. This pathway deteriorates in aging and in AD and “has been suggested to play a role in mediating episodic memory, language, socio-emotional processing, and selecting among competing memories during retrieval.”

No significant differences were found between the groups in olfactory ability.

Limitations of the study include its small sample size. The investigators hope the findings will “stimulate larger scale clinical trials systematically testing the therapeutic efficacy of olfactory enrichment in treating memory loss in older adults.”
 

Exciting but preliminary

Commenting for this article, Donald Wilson, PhD, professor of child and adolescent psychiatry and of neuroscience and physiology, the Child Study Center, NYU Langone Medical Center, New York, said that multiple studies have “demonstrated that problems with sense of smell are associated with and sometimes can precede other symptoms for many disorders, including AD, Parkinson’s disease, and depression.”

Recent work has suggested that this relationship can be “bidirectional” – for example, losing one’s sense of smell might promote depression, while depressive disorder might lead to impaired smell, according to Dr. Wilson, also director and senior research scientist, the Emotional Brain Institute, Nathan Kline Institute for Psychiatric Research. He was not involved with the study.

This “two-way interaction” may raise the possibility that “improving olfaction could impact nonolfactory disorders.”

This paper “brings together” previous research findings to show that odors during bedtime can improve some aspects of cognitive function and circuits that are known to be important for memory and cognition – which Dr. Wilson called “a very exciting, though relatively preliminary, finding.”

A caveat is that several measures of cognitive function were assessed and only one (verbal memory) showed clear improvement.

Nevertheless, there’s “very strong interest now in the olfactory and nonolfactory aspects of odor training and this training expands the training possibilities to sleep. This could be a powerful tool for cognitive improvement and/or rescue if follow-up studies support these findings,” Dr. Wilson said.

A version of this article appeared on Medscape.com.

Inhaling a pleasant aroma during sleep has been linked to a “dramatic” improvement in memory, early research suggests.

In a small, randomized controlled trial researchers found that when cognitively normal individuals were exposed to the scent of an essential oil for 2 hours every night over 6 months, they experienced a 226% improvement in memory compared with a control group who received only a trace amount of the diffused scent.

In addition, functional magnetic resonance imaging (fMRI) showed that those in the enriched group had improved functioning of the left uncinate fasciculus, an area of the brain linked to memory and cognition, which typically declines with age.

“To my knowledge, that level of [memory] improvement is far greater than anything that has been reported for healthy older adults and we also found a critical memory pathway in their brains improved to a similar extent relative to unenriched older adults,” senior investigator Michael Leon, PhD, professor emeritus, University of California, Irvine, said in an interview.

The study was published online in Frontiers of Neuroscience.
 

The brain’s “superhighway”

Olfactory enrichment “involves the daily exposure of individuals to multiple odorants” and has been shown in mouse models to improve memory and neurogenesis, the investigators noted.

A previous study showed that exposure to individual essential oils for 30 minutes a day over 3 months induced neurogenesis in the olfactory bulb and the hippocampus.

“The olfactory system is the only sense that has a direct ‘superhighway’ input to the memory centers areas of the brain; all the other senses have to reach those brain areas through what you might call the ‘side streets’ of the brain, and so consequently, they have much less impact on maintaining the health of those memory centers.”

When olfaction is compromised, “the memory centers of the brain start to deteriorate and, conversely, when people are given olfactory enrichment, their memory areas become larger and more functional,” he added.

Olfactory dysfunction is the first symptom of Alzheimer’s disease (AD) and is also found in virtually all neurological and psychiatric disorders.

“I’ve counted 68 of them – including anorexia, anxiety, [attention-deficit/hyperactivity disorder], depression, epilepsy, and stroke. In fact, by mid-life, your all-cause mortality can be predicted by your ability to smell things,” Dr. Leon said.

Dr. Leon and colleagues previously developed an effective treatment for autism using environmental enrichment that focused on odor stimulation, along with stimulating other senses. “We then considered the possibility that olfactory enrichment alone might improve brain function.”
 

Rose, orange, eucalyptus …

For the study, the researchers randomly assigned 43 older adults, aged 60-85 years, to receive either nightly exposure to essential oil scents delivered via a diffuser (n = 20; mean [SD] age, 70.1 [6.6] years) or to a sham control with only trace amounts of odorants (n = 23; mean age, 69.2 [7.1] years) for a period of 6 months.

The intervention group was exposed to a single odorant, delivered through a diffuser, for 2 hours nightly, rotating through seven pleasant aromas each week. They included rose, orange, eucalyptus, lemon, peppermint, rosemary, and lavender scents.

All participants completed a battery of tests at baseline, including the Mini-Mental State Examination (MMSE), which confirmed normal cognitive functioning. At baseline and after a 6-month follow-up, participants completed the Rey Auditory Verbal Learning Test (RAVLT) as well as three subsets of the Wechsler Adult Intelligence Scale–Third Edition (WAIS-III).

Olfactory system function was assessed using “Sniffin Sticks,” allowing the researchers to determine if olfactory enrichment enhanced olfactory performance.

Participants underwent fMRI at baseline and again at 6 months.

Brain imaging results showed a “clear, statistically significant 226% difference between enriched and control older adults in performance on the RAVLT, which evaluates learning and memory (timepoint × group interaction; F = 6.63; P = .02; Cohen’s d = 1.08; a “large effect size”).

They also found a significant change in the mean diffusivity of the left uncinate fasciculus in the enriched group compared with the controls (timepoint × group interaction; F = 4.39; P = .043; h 2 p = .101; a “medium-size effect”).

The uncinate fasciculus is a “major pathway” connecting the basolateral amygdala and the entorhinal cortex to the prefrontal cortex. This pathway deteriorates in aging and in AD and “has been suggested to play a role in mediating episodic memory, language, socio-emotional processing, and selecting among competing memories during retrieval.”

No significant differences were found between the groups in olfactory ability.

Limitations of the study include its small sample size. The investigators hope the findings will “stimulate larger scale clinical trials systematically testing the therapeutic efficacy of olfactory enrichment in treating memory loss in older adults.”
 

Exciting but preliminary

Commenting for this article, Donald Wilson, PhD, professor of child and adolescent psychiatry and of neuroscience and physiology, the Child Study Center, NYU Langone Medical Center, New York, said that multiple studies have “demonstrated that problems with sense of smell are associated with and sometimes can precede other symptoms for many disorders, including AD, Parkinson’s disease, and depression.”

Recent work has suggested that this relationship can be “bidirectional” – for example, losing one’s sense of smell might promote depression, while depressive disorder might lead to impaired smell, according to Dr. Wilson, also director and senior research scientist, the Emotional Brain Institute, Nathan Kline Institute for Psychiatric Research. He was not involved with the study.

This “two-way interaction” may raise the possibility that “improving olfaction could impact nonolfactory disorders.”

This paper “brings together” previous research findings to show that odors during bedtime can improve some aspects of cognitive function and circuits that are known to be important for memory and cognition – which Dr. Wilson called “a very exciting, though relatively preliminary, finding.”

A caveat is that several measures of cognitive function were assessed and only one (verbal memory) showed clear improvement.

Nevertheless, there’s “very strong interest now in the olfactory and nonolfactory aspects of odor training and this training expands the training possibilities to sleep. This could be a powerful tool for cognitive improvement and/or rescue if follow-up studies support these findings,” Dr. Wilson said.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

We need to think about the ways that participating in clinical trials results in increased out-of-pocket costs to our patients and how that limits the ability of marginalized groups to participate. That should be a problem for us.

There are many subtle and some egregious ways that participating in clinical trials can result in increased costs. We may ask patients to come to the clinic more frequently. That may mean costs for transportation, wear and tear on your car, and gas prices. It may also mean that if you work in a job where you don’t have time off, and if you’re not at work, you don’t get paid. That’s a major hit to your take-home pay.

We also need to take a close and more honest look at our study budgets and what we consider standard of care. Now, this becomes a slippery slope because there are clear recommendations that we would all agree, but there are also differences of practice and differences of opinion.

How often should patients with advanced disease, who clinically are doing well, have scans to evaluate their disease status and look for subtle evidence of progression? Are laboratory studies part of the follow-up in patients in the adjuvant setting? Did you really need a urinalysis in somebody who’s going to be starting chemotherapy? Do you need an EKG if you’re going to be giving them a drug that doesn’t have potential cardiac toxicity, for which QTc prolongation is not a problem?

Those are often included in our clinical trials. In some cases, they might be paid for by the trial. In other cases, they’re billed to the insurance provider, which means they’ll contribute to deductibles and copays will apply. It is very likely that they will cost your patient something out of pocket.

Now, this becomes important because many of our consent forms would specifically say that things that are only done for the study are paid for by the study. How we define standard of care becomes vitally important. These issues have not been linked in this way frequently. It is time for us to tackle this problem and think about how we financially support the additional costs of care that can be real barriers for patients to participate in clinical trials.

Clinical trials are how we make progress. The more patients who are able to participate in clinical trials, the better it is for all of us and all our future patients.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.
 

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

This transcript has been edited for clarity.

We need to think about the ways that participating in clinical trials results in increased out-of-pocket costs to our patients and how that limits the ability of marginalized groups to participate. That should be a problem for us.

There are many subtle and some egregious ways that participating in clinical trials can result in increased costs. We may ask patients to come to the clinic more frequently. That may mean costs for transportation, wear and tear on your car, and gas prices. It may also mean that if you work in a job where you don’t have time off, and if you’re not at work, you don’t get paid. That’s a major hit to your take-home pay.

We also need to take a close and more honest look at our study budgets and what we consider standard of care. Now, this becomes a slippery slope because there are clear recommendations that we would all agree, but there are also differences of practice and differences of opinion.

How often should patients with advanced disease, who clinically are doing well, have scans to evaluate their disease status and look for subtle evidence of progression? Are laboratory studies part of the follow-up in patients in the adjuvant setting? Did you really need a urinalysis in somebody who’s going to be starting chemotherapy? Do you need an EKG if you’re going to be giving them a drug that doesn’t have potential cardiac toxicity, for which QTc prolongation is not a problem?

Those are often included in our clinical trials. In some cases, they might be paid for by the trial. In other cases, they’re billed to the insurance provider, which means they’ll contribute to deductibles and copays will apply. It is very likely that they will cost your patient something out of pocket.

Now, this becomes important because many of our consent forms would specifically say that things that are only done for the study are paid for by the study. How we define standard of care becomes vitally important. These issues have not been linked in this way frequently. It is time for us to tackle this problem and think about how we financially support the additional costs of care that can be real barriers for patients to participate in clinical trials.

Clinical trials are how we make progress. The more patients who are able to participate in clinical trials, the better it is for all of us and all our future patients.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.
 

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

This transcript has been edited for clarity.

We need to think about the ways that participating in clinical trials results in increased out-of-pocket costs to our patients and how that limits the ability of marginalized groups to participate. That should be a problem for us.

There are many subtle and some egregious ways that participating in clinical trials can result in increased costs. We may ask patients to come to the clinic more frequently. That may mean costs for transportation, wear and tear on your car, and gas prices. It may also mean that if you work in a job where you don’t have time off, and if you’re not at work, you don’t get paid. That’s a major hit to your take-home pay.

We also need to take a close and more honest look at our study budgets and what we consider standard of care. Now, this becomes a slippery slope because there are clear recommendations that we would all agree, but there are also differences of practice and differences of opinion.

How often should patients with advanced disease, who clinically are doing well, have scans to evaluate their disease status and look for subtle evidence of progression? Are laboratory studies part of the follow-up in patients in the adjuvant setting? Did you really need a urinalysis in somebody who’s going to be starting chemotherapy? Do you need an EKG if you’re going to be giving them a drug that doesn’t have potential cardiac toxicity, for which QTc prolongation is not a problem?

Those are often included in our clinical trials. In some cases, they might be paid for by the trial. In other cases, they’re billed to the insurance provider, which means they’ll contribute to deductibles and copays will apply. It is very likely that they will cost your patient something out of pocket.

Now, this becomes important because many of our consent forms would specifically say that things that are only done for the study are paid for by the study. How we define standard of care becomes vitally important. These issues have not been linked in this way frequently. It is time for us to tackle this problem and think about how we financially support the additional costs of care that can be real barriers for patients to participate in clinical trials.

Clinical trials are how we make progress. The more patients who are able to participate in clinical trials, the better it is for all of us and all our future patients.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.
 

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

Andrea Partida, DO, an obstetrician and gynecologist in Enid, Okla., loves her new assistant.

The 15 or 20 minutes she used to spend on documentation for each patient visit is now 3. The 2-3 hours she’d spend charting outside clinic hours is maybe 1.

All that time saved allows her to see two to five more patients a day, provide better care to each patient, and get more involved in hospital leadership at Integris Health, where she works.

“I have a better work-life balance with my family,” Dr. Partida said. “I leave work at work and get home earlier.”

You’ve probably figured out the plot twist: Dr. Partida’s assistant is not a person – it’s artificial intelligence (AI).

Dr. Partida uses IRIS, a tool from OnPoint Healthcare Partners, part of a fast-growing niche of AI medical scribes designed to automate onerous data entry. The evolution of generative AI – specifically, large language models, such as ChatGPT – has led to a rapid explosion of these tools. Other companies in the space include Abridge, Ambience Healthcare, Augmedix, DeepScribe, Nuance (part of Microsoft), and Suki. The newest kid on the block, Amazon Web Services, announced the launch of HealthScribe in July.

These tools – some of which are already on the market, with more on the way – record patient visits and generate notes for treatment and billing. Earlier iterations combine AI with offsite human scribes who provide quality control. But more and more are fully automated, no human required. Some also offer video recording and foreign language translation.

The promise is alluring: Ease your workload and reclaim hours in your day so you can spend more time with patients or try that “work-life balance” thing you’ve heard so much about.

But do these tools fulfill that promise?

According to Dr. Partida and other doctors who spoke with this news organization, the answer is a resounding yes.
 

A tech solution for a tech problem

“I believe a lot of doctors see patients for free. They get paid to do paperwork,” said Anthony J. Mazzarelli, MD, JD, MBE, co-president and CEO of Cooper University Health Care, in Camden, N.J.

Indeed, for every hour U.S. clinicians spend with their patients, they may spend 2 more hours documenting in electronic health records (EHRs), estimates show. About half of doctors, especially those in primary care, report feeling burned out, and some 42% say they want to quit clinical practice.

Enter AI scribes.

“The holy grail in medicine right now is improving burnout while also maintaining or improving productivity and quality,” said Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford (Calif.) Health Care. “These ambient digital scribes have the potential to do just that.”

While anyone can buy these products, their use has been mostly limited to pilot programs and early adopters so far, said Dr. Garcia, who has been helping to pilot Nuance’s digital scribe, DAX, at Stanford.

But that’s expected to change quickly. “I don’t think the time horizon is a decade,” Dr. Garcia said. “I think within a matter of 2 or 3 years, these tools will be pervasive throughout health care.”

Since introducing these tools at Cooper, “our doctors’ paperwork burden is significantly lighter,” said Dr. Mazzarelli, who decides which technologies Cooper should invest in and who monitors their results. In Cooper studies, physicians who used DAX more than half the time spent 43% less time working on notes.

“They spend more time connecting with their patients, talking with them, and looking them in the eye,” Dr. Mazzarelli said. That, in turn, seems to improve patient outcomes, reduce doctor burnout and turnover, and lower costs.

The AI scribes, by virtue of eliminating the distraction of note taking, also allow doctors to give their full attention to the patient. “The patient relationship is the most important aspect of medicine,” said Raul Ayala, MD, MHCM, a family medicine physician at Adventist Health, in Hanford, Calif., who uses Augmedix. The digital scribe “helps us strengthen that relationship.”
 

What’s it like to use an AI medical scribe?

The scribes feature hardware (typically a smartphone or tablet) and software built on automatic speech recognition, natural language processing, and machine learning. Download an app to your device, and you’re ready to go. Use it to record in-person or telehealth visits.

In the first week, a company may help train you to use the hardware and software. You’ll likely start by using it for a few patient visits per day, ramping up gradually. Dr. Partida said she was comfortable using the system for all her patients in 6 weeks.

Each day, Dr. Partida logs in to a dedicated smartphone or tablet, opens the app, and reviews her schedule, including details she needs to prepare for each patient.

At the start of each patient visit, Dr. Partida taps the app icon to begin recording and lays the device nearby. She can pause as needed. At the end of the visit, she taps the icon again to stop recording.

The AI listens, creates the note, and updates relevant data in the EHR. The note includes patient problems, assessment, treatment plan, patient history, orders, and tasks for staff, along with medications, referrals, and preauthorizations. A human scribe, who is also a physician, reviews the information for accuracy and edits it as needed. By the next morning, the data are ready for Dr. Partida to review.

Fully automated versions can generate notes much faster. Jack Shilling, MD, MBA, an orthopedic surgeon at Cooper University Health Care, in Voorhees, N.J., uses DAX. A new feature called DAX Express – which uses OpenAI’s GPT-4 but no humans – provides him with a draft of his clinical notes in just seconds.
 

How accurate are AI notes?

The accuracy of those notes remains an open question, Dr. Garcia said – mostly because accuracy can be hard to define.

“If you asked five docs to write a note based on the same patient encounter, you’d get five different notes,” Dr. Garcia said. “That makes it hard to assess these technologies in a scientifically rigorous way.”

Still, the onus is on the physician to review the notes and edit them as needed, Dr. Garcia said. How light or heavy those edits are can depend on your unique preferences.

Dr. Shilling said he may need to lightly edit transcripts of his conversations with patients. “When someone tells me how long their knee hurts, slight variability in their transcribed words is tolerable,” he said. But for some things – such as physical exam notes and x-ray readings – he dictates directly into the device, speaking at a closer range and being less conversational, more exact in his speech.
 

Should you let patients know they’re being recorded?

The federal Health Insurance Portability and Accountability Act (HIPAA) does not require providers to inform patients that their face-to-face conversations are being recorded, said Daniel Lebovic, JD, corporate legal counsel at Compliancy Group, in Greenlawn, N.Y., a company that helps providers adhere to HIPAA rules.

But make sure you know the laws in your state and the policies at your health care practice. State laws may require providers to inform patients and to get patients’ consent in advance of being recorded.

All the doctors who spoke to this news organization said their patients are informed that they’ll be recorded and that they can opt out if they wish.
 

How much do AI scribes cost?

As the marketplace for these tools expands, companies are offering more products and services at different price points that target a range of organizations, from large health care systems to small private practices.

Price models vary, said Dr. Garcia. Some are based on the number of users, others on the number of notes, and still others on minutes.

Amazon’s HealthScribe is priced at 10 cents per minute. For 1,000 consultation transcripts per month, with each call averaging 15 minutes, it would take 15,000 minutes at a total cost of $1,500 for the month.

In general, the rapidly growing competition in this space could mean prices become more affordable, Dr. Garcia said. “It’s good that so many are getting into this game, because that means the price will come down and it will be a lot more accessible to everybody.”

A version of this article appeared on Medscape.com.

Andrea Partida, DO, an obstetrician and gynecologist in Enid, Okla., loves her new assistant.

The 15 or 20 minutes she used to spend on documentation for each patient visit is now 3. The 2-3 hours she’d spend charting outside clinic hours is maybe 1.

All that time saved allows her to see two to five more patients a day, provide better care to each patient, and get more involved in hospital leadership at Integris Health, where she works.

“I have a better work-life balance with my family,” Dr. Partida said. “I leave work at work and get home earlier.”

You’ve probably figured out the plot twist: Dr. Partida’s assistant is not a person – it’s artificial intelligence (AI).

Dr. Partida uses IRIS, a tool from OnPoint Healthcare Partners, part of a fast-growing niche of AI medical scribes designed to automate onerous data entry. The evolution of generative AI – specifically, large language models, such as ChatGPT – has led to a rapid explosion of these tools. Other companies in the space include Abridge, Ambience Healthcare, Augmedix, DeepScribe, Nuance (part of Microsoft), and Suki. The newest kid on the block, Amazon Web Services, announced the launch of HealthScribe in July.

These tools – some of which are already on the market, with more on the way – record patient visits and generate notes for treatment and billing. Earlier iterations combine AI with offsite human scribes who provide quality control. But more and more are fully automated, no human required. Some also offer video recording and foreign language translation.

The promise is alluring: Ease your workload and reclaim hours in your day so you can spend more time with patients or try that “work-life balance” thing you’ve heard so much about.

But do these tools fulfill that promise?

According to Dr. Partida and other doctors who spoke with this news organization, the answer is a resounding yes.
 

A tech solution for a tech problem

“I believe a lot of doctors see patients for free. They get paid to do paperwork,” said Anthony J. Mazzarelli, MD, JD, MBE, co-president and CEO of Cooper University Health Care, in Camden, N.J.

Indeed, for every hour U.S. clinicians spend with their patients, they may spend 2 more hours documenting in electronic health records (EHRs), estimates show. About half of doctors, especially those in primary care, report feeling burned out, and some 42% say they want to quit clinical practice.

Enter AI scribes.

“The holy grail in medicine right now is improving burnout while also maintaining or improving productivity and quality,” said Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford (Calif.) Health Care. “These ambient digital scribes have the potential to do just that.”

While anyone can buy these products, their use has been mostly limited to pilot programs and early adopters so far, said Dr. Garcia, who has been helping to pilot Nuance’s digital scribe, DAX, at Stanford.

But that’s expected to change quickly. “I don’t think the time horizon is a decade,” Dr. Garcia said. “I think within a matter of 2 or 3 years, these tools will be pervasive throughout health care.”

Since introducing these tools at Cooper, “our doctors’ paperwork burden is significantly lighter,” said Dr. Mazzarelli, who decides which technologies Cooper should invest in and who monitors their results. In Cooper studies, physicians who used DAX more than half the time spent 43% less time working on notes.

“They spend more time connecting with their patients, talking with them, and looking them in the eye,” Dr. Mazzarelli said. That, in turn, seems to improve patient outcomes, reduce doctor burnout and turnover, and lower costs.

The AI scribes, by virtue of eliminating the distraction of note taking, also allow doctors to give their full attention to the patient. “The patient relationship is the most important aspect of medicine,” said Raul Ayala, MD, MHCM, a family medicine physician at Adventist Health, in Hanford, Calif., who uses Augmedix. The digital scribe “helps us strengthen that relationship.”
 

What’s it like to use an AI medical scribe?

The scribes feature hardware (typically a smartphone or tablet) and software built on automatic speech recognition, natural language processing, and machine learning. Download an app to your device, and you’re ready to go. Use it to record in-person or telehealth visits.

In the first week, a company may help train you to use the hardware and software. You’ll likely start by using it for a few patient visits per day, ramping up gradually. Dr. Partida said she was comfortable using the system for all her patients in 6 weeks.

Each day, Dr. Partida logs in to a dedicated smartphone or tablet, opens the app, and reviews her schedule, including details she needs to prepare for each patient.

At the start of each patient visit, Dr. Partida taps the app icon to begin recording and lays the device nearby. She can pause as needed. At the end of the visit, she taps the icon again to stop recording.

The AI listens, creates the note, and updates relevant data in the EHR. The note includes patient problems, assessment, treatment plan, patient history, orders, and tasks for staff, along with medications, referrals, and preauthorizations. A human scribe, who is also a physician, reviews the information for accuracy and edits it as needed. By the next morning, the data are ready for Dr. Partida to review.

Fully automated versions can generate notes much faster. Jack Shilling, MD, MBA, an orthopedic surgeon at Cooper University Health Care, in Voorhees, N.J., uses DAX. A new feature called DAX Express – which uses OpenAI’s GPT-4 but no humans – provides him with a draft of his clinical notes in just seconds.
 

How accurate are AI notes?

The accuracy of those notes remains an open question, Dr. Garcia said – mostly because accuracy can be hard to define.

“If you asked five docs to write a note based on the same patient encounter, you’d get five different notes,” Dr. Garcia said. “That makes it hard to assess these technologies in a scientifically rigorous way.”

Still, the onus is on the physician to review the notes and edit them as needed, Dr. Garcia said. How light or heavy those edits are can depend on your unique preferences.

Dr. Shilling said he may need to lightly edit transcripts of his conversations with patients. “When someone tells me how long their knee hurts, slight variability in their transcribed words is tolerable,” he said. But for some things – such as physical exam notes and x-ray readings – he dictates directly into the device, speaking at a closer range and being less conversational, more exact in his speech.
 

Should you let patients know they’re being recorded?

The federal Health Insurance Portability and Accountability Act (HIPAA) does not require providers to inform patients that their face-to-face conversations are being recorded, said Daniel Lebovic, JD, corporate legal counsel at Compliancy Group, in Greenlawn, N.Y., a company that helps providers adhere to HIPAA rules.

But make sure you know the laws in your state and the policies at your health care practice. State laws may require providers to inform patients and to get patients’ consent in advance of being recorded.

All the doctors who spoke to this news organization said their patients are informed that they’ll be recorded and that they can opt out if they wish.
 

How much do AI scribes cost?

As the marketplace for these tools expands, companies are offering more products and services at different price points that target a range of organizations, from large health care systems to small private practices.

Price models vary, said Dr. Garcia. Some are based on the number of users, others on the number of notes, and still others on minutes.

Amazon’s HealthScribe is priced at 10 cents per minute. For 1,000 consultation transcripts per month, with each call averaging 15 minutes, it would take 15,000 minutes at a total cost of $1,500 for the month.

In general, the rapidly growing competition in this space could mean prices become more affordable, Dr. Garcia said. “It’s good that so many are getting into this game, because that means the price will come down and it will be a lot more accessible to everybody.”

A version of this article appeared on Medscape.com.

Andrea Partida, DO, an obstetrician and gynecologist in Enid, Okla., loves her new assistant.

The 15 or 20 minutes she used to spend on documentation for each patient visit is now 3. The 2-3 hours she’d spend charting outside clinic hours is maybe 1.

All that time saved allows her to see two to five more patients a day, provide better care to each patient, and get more involved in hospital leadership at Integris Health, where she works.

“I have a better work-life balance with my family,” Dr. Partida said. “I leave work at work and get home earlier.”

You’ve probably figured out the plot twist: Dr. Partida’s assistant is not a person – it’s artificial intelligence (AI).

Dr. Partida uses IRIS, a tool from OnPoint Healthcare Partners, part of a fast-growing niche of AI medical scribes designed to automate onerous data entry. The evolution of generative AI – specifically, large language models, such as ChatGPT – has led to a rapid explosion of these tools. Other companies in the space include Abridge, Ambience Healthcare, Augmedix, DeepScribe, Nuance (part of Microsoft), and Suki. The newest kid on the block, Amazon Web Services, announced the launch of HealthScribe in July.

These tools – some of which are already on the market, with more on the way – record patient visits and generate notes for treatment and billing. Earlier iterations combine AI with offsite human scribes who provide quality control. But more and more are fully automated, no human required. Some also offer video recording and foreign language translation.

The promise is alluring: Ease your workload and reclaim hours in your day so you can spend more time with patients or try that “work-life balance” thing you’ve heard so much about.

But do these tools fulfill that promise?

According to Dr. Partida and other doctors who spoke with this news organization, the answer is a resounding yes.
 

A tech solution for a tech problem

“I believe a lot of doctors see patients for free. They get paid to do paperwork,” said Anthony J. Mazzarelli, MD, JD, MBE, co-president and CEO of Cooper University Health Care, in Camden, N.J.

Indeed, for every hour U.S. clinicians spend with their patients, they may spend 2 more hours documenting in electronic health records (EHRs), estimates show. About half of doctors, especially those in primary care, report feeling burned out, and some 42% say they want to quit clinical practice.

Enter AI scribes.

“The holy grail in medicine right now is improving burnout while also maintaining or improving productivity and quality,” said Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford (Calif.) Health Care. “These ambient digital scribes have the potential to do just that.”

While anyone can buy these products, their use has been mostly limited to pilot programs and early adopters so far, said Dr. Garcia, who has been helping to pilot Nuance’s digital scribe, DAX, at Stanford.

But that’s expected to change quickly. “I don’t think the time horizon is a decade,” Dr. Garcia said. “I think within a matter of 2 or 3 years, these tools will be pervasive throughout health care.”

Since introducing these tools at Cooper, “our doctors’ paperwork burden is significantly lighter,” said Dr. Mazzarelli, who decides which technologies Cooper should invest in and who monitors their results. In Cooper studies, physicians who used DAX more than half the time spent 43% less time working on notes.

“They spend more time connecting with their patients, talking with them, and looking them in the eye,” Dr. Mazzarelli said. That, in turn, seems to improve patient outcomes, reduce doctor burnout and turnover, and lower costs.

The AI scribes, by virtue of eliminating the distraction of note taking, also allow doctors to give their full attention to the patient. “The patient relationship is the most important aspect of medicine,” said Raul Ayala, MD, MHCM, a family medicine physician at Adventist Health, in Hanford, Calif., who uses Augmedix. The digital scribe “helps us strengthen that relationship.”
 

What’s it like to use an AI medical scribe?

The scribes feature hardware (typically a smartphone or tablet) and software built on automatic speech recognition, natural language processing, and machine learning. Download an app to your device, and you’re ready to go. Use it to record in-person or telehealth visits.

In the first week, a company may help train you to use the hardware and software. You’ll likely start by using it for a few patient visits per day, ramping up gradually. Dr. Partida said she was comfortable using the system for all her patients in 6 weeks.

Each day, Dr. Partida logs in to a dedicated smartphone or tablet, opens the app, and reviews her schedule, including details she needs to prepare for each patient.

At the start of each patient visit, Dr. Partida taps the app icon to begin recording and lays the device nearby. She can pause as needed. At the end of the visit, she taps the icon again to stop recording.

The AI listens, creates the note, and updates relevant data in the EHR. The note includes patient problems, assessment, treatment plan, patient history, orders, and tasks for staff, along with medications, referrals, and preauthorizations. A human scribe, who is also a physician, reviews the information for accuracy and edits it as needed. By the next morning, the data are ready for Dr. Partida to review.

Fully automated versions can generate notes much faster. Jack Shilling, MD, MBA, an orthopedic surgeon at Cooper University Health Care, in Voorhees, N.J., uses DAX. A new feature called DAX Express – which uses OpenAI’s GPT-4 but no humans – provides him with a draft of his clinical notes in just seconds.
 

How accurate are AI notes?

The accuracy of those notes remains an open question, Dr. Garcia said – mostly because accuracy can be hard to define.

“If you asked five docs to write a note based on the same patient encounter, you’d get five different notes,” Dr. Garcia said. “That makes it hard to assess these technologies in a scientifically rigorous way.”

Still, the onus is on the physician to review the notes and edit them as needed, Dr. Garcia said. How light or heavy those edits are can depend on your unique preferences.

Dr. Shilling said he may need to lightly edit transcripts of his conversations with patients. “When someone tells me how long their knee hurts, slight variability in their transcribed words is tolerable,” he said. But for some things – such as physical exam notes and x-ray readings – he dictates directly into the device, speaking at a closer range and being less conversational, more exact in his speech.
 

Should you let patients know they’re being recorded?

The federal Health Insurance Portability and Accountability Act (HIPAA) does not require providers to inform patients that their face-to-face conversations are being recorded, said Daniel Lebovic, JD, corporate legal counsel at Compliancy Group, in Greenlawn, N.Y., a company that helps providers adhere to HIPAA rules.

But make sure you know the laws in your state and the policies at your health care practice. State laws may require providers to inform patients and to get patients’ consent in advance of being recorded.

All the doctors who spoke to this news organization said their patients are informed that they’ll be recorded and that they can opt out if they wish.
 

How much do AI scribes cost?

As the marketplace for these tools expands, companies are offering more products and services at different price points that target a range of organizations, from large health care systems to small private practices.

Price models vary, said Dr. Garcia. Some are based on the number of users, others on the number of notes, and still others on minutes.

Amazon’s HealthScribe is priced at 10 cents per minute. For 1,000 consultation transcripts per month, with each call averaging 15 minutes, it would take 15,000 minutes at a total cost of $1,500 for the month.

In general, the rapidly growing competition in this space could mean prices become more affordable, Dr. Garcia said. “It’s good that so many are getting into this game, because that means the price will come down and it will be a lot more accessible to everybody.”

A version of this article appeared on Medscape.com.

Sometimes we get what we pay for. Other times we pay too much. 

That’s the message of a study published in Annals of Internal Medicine, which finds that a generic maintenance inhaler is as effective at managing symptoms of chronic obstructive pulmonary disorder (COPD) as a pricier branded alternative. 

In 2019, the Food and Drug Administration approved Wixela Inhub (the combination corticosteroid/long-acting beta² adrenergic agonist fluticasone-salmeterol; Viatris) as a generic dry powder inhaler for managing symptoms of COPD. This approval was based on evidence of the generic’s effectiveness against asthma, although COPD also was on the product label. The study authors compared Wixela’s effectiveness in controlling symptoms of COPD with that of the brand name inhaler Advair Diskus (fluticasone-salmeterol; GlaxoSmithKline), which uses the same active ingredients.

The result: “The generic looks to be as safe and effective as the brand name. I don’t see a clinical reason why one would ever need to get the brand name over the generic version,” said study author William Feldman, MD, DPhil, MPH, a health services researcher and pulmonologist at Harvard Medical School and Brigham and Women’s Hospital, both in Boston.
 

Same types of patients, different inhalers, same outcomes

Dr. Feldman and colleagues compared the medical records of 10,000 patients with COPD who began using the branded inhaler to the records of another 10,000 patients with COPD who opted for the generic alternative. Participants in the two groups were evenly matched by age, sex, race, and ethnicity, region, severity of COPD, and presence of other comorbidities, according to the researchers. Participants were all older than age 40, and the average age in both groups was 72 years.

The researchers looked for a difference in a first episode of a moderate exacerbation of COPD, defined as requiring a course of prednisone for 5-14 days. They also looked for cases of severe COPD exacerbation requiring hospitalization in the year after people began using either the generic or brand name inhaler. And they looked for differences across 1 year in rates of hospitalization for pneumonia.

For none of those outcomes, however, did the type of inhaler appear to matter. Compared with the brand-name drug, using the generic was associated with nearly identical rates of moderate or severe COPD exacerbation (hazard ratio, 0.97; 95% confidence interval, 0.90-1.04. The same was true for the proportion of people who went to the hospital for pneumonia at least once (HR, 0.99; 95% CI, 0.86-1.15).

“To get through the FDA as an interchangeable generic, the generic firms have to show that their product can be used in just the same way as the brand-name version,” Dr. Feldman said, which may explain why the generic and brand-name versions of the inhaler performed so similarly.

Dr. Feldman cautioned that the price savings for patients who opt for the generic over the branded product are hard to determine, given the vagaries of different insurance plans and potential rebates when using the branded project. As a general matter, having a single generic competitor will not lower costs much, Dr. Feldman noted, pointing to 2017 research from Harvard that found a profusion of generic competitors is needed to significantly lower health care costs.

“I don’t want to in any way underestimate the importance of getting that first generic onto the market, because it sets the stage for future generics,” Dr. Feldman said.  

“There are very few generic options for patients with COPD,” said Surya Bhatt, MD, director of the Pulmonary Function and Exercise Physiology Lab at the University of Alabama at Birmingham. Even the rescue inhalers that people with COPD use to manage acute episodes of the condition are usually branded at this time, Dr. Bhatt noted, with few generic options.*

“The results are quite compelling,” said Dr. Bhatt, who was not involved in the research. Although the trial was not randomized, he commended the researchers for stratifying participants in the two groups to be as comparable as possible.

Dr. Bhatt noted that the FDA’s 2019 approval – given that the agency requires bioequivalence studies between branded and generic products – was enough to cause him to begin prescribing the generic inhaler. The fact that this approval was based on asthma but not also COPD is not a concern.

“There are so many similarities between asthma, COPD, and some obstructive lung diseases,” Dr. Bhatt noted.

In his experience, the only time someone with COPD continues using the branded inhaler – now that a potentially cheaper generic is available – is when their insurance plan makes their out-of-pocket cost minimal. Otherwise, brand loyalty does not exist.

“Patients are generally okay with being on a generic for inhalers, just because of the high cost,” Dr. Bhatt said.

The study was primarily supported by the National Heart, Lung, and Blood Institute. Dr. Feldman reported funding from Arnold Ventures, the Commonwealth Fund, and the FDA, and consulting relationships with Alosa Health and Aetion. Dr. Bhatt reported no relevant financial relationships.

*Correction, 8/16/23: An earlier version of this article mischaracterized Dr. Bhatt's comments on the availability of generic options.

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

Sometimes we get what we pay for. Other times we pay too much. 

That’s the message of a study published in Annals of Internal Medicine, which finds that a generic maintenance inhaler is as effective at managing symptoms of chronic obstructive pulmonary disorder (COPD) as a pricier branded alternative. 

In 2019, the Food and Drug Administration approved Wixela Inhub (the combination corticosteroid/long-acting beta² adrenergic agonist fluticasone-salmeterol; Viatris) as a generic dry powder inhaler for managing symptoms of COPD. This approval was based on evidence of the generic’s effectiveness against asthma, although COPD also was on the product label. The study authors compared Wixela’s effectiveness in controlling symptoms of COPD with that of the brand name inhaler Advair Diskus (fluticasone-salmeterol; GlaxoSmithKline), which uses the same active ingredients.

The result: “The generic looks to be as safe and effective as the brand name. I don’t see a clinical reason why one would ever need to get the brand name over the generic version,” said study author William Feldman, MD, DPhil, MPH, a health services researcher and pulmonologist at Harvard Medical School and Brigham and Women’s Hospital, both in Boston.
 

Same types of patients, different inhalers, same outcomes

Dr. Feldman and colleagues compared the medical records of 10,000 patients with COPD who began using the branded inhaler to the records of another 10,000 patients with COPD who opted for the generic alternative. Participants in the two groups were evenly matched by age, sex, race, and ethnicity, region, severity of COPD, and presence of other comorbidities, according to the researchers. Participants were all older than age 40, and the average age in both groups was 72 years.

The researchers looked for a difference in a first episode of a moderate exacerbation of COPD, defined as requiring a course of prednisone for 5-14 days. They also looked for cases of severe COPD exacerbation requiring hospitalization in the year after people began using either the generic or brand name inhaler. And they looked for differences across 1 year in rates of hospitalization for pneumonia.

For none of those outcomes, however, did the type of inhaler appear to matter. Compared with the brand-name drug, using the generic was associated with nearly identical rates of moderate or severe COPD exacerbation (hazard ratio, 0.97; 95% confidence interval, 0.90-1.04. The same was true for the proportion of people who went to the hospital for pneumonia at least once (HR, 0.99; 95% CI, 0.86-1.15).

“To get through the FDA as an interchangeable generic, the generic firms have to show that their product can be used in just the same way as the brand-name version,” Dr. Feldman said, which may explain why the generic and brand-name versions of the inhaler performed so similarly.

Dr. Feldman cautioned that the price savings for patients who opt for the generic over the branded product are hard to determine, given the vagaries of different insurance plans and potential rebates when using the branded project. As a general matter, having a single generic competitor will not lower costs much, Dr. Feldman noted, pointing to 2017 research from Harvard that found a profusion of generic competitors is needed to significantly lower health care costs.

“I don’t want to in any way underestimate the importance of getting that first generic onto the market, because it sets the stage for future generics,” Dr. Feldman said.  

“There are very few generic options for patients with COPD,” said Surya Bhatt, MD, director of the Pulmonary Function and Exercise Physiology Lab at the University of Alabama at Birmingham. Even the rescue inhalers that people with COPD use to manage acute episodes of the condition are usually branded at this time, Dr. Bhatt noted, with few generic options.*

“The results are quite compelling,” said Dr. Bhatt, who was not involved in the research. Although the trial was not randomized, he commended the researchers for stratifying participants in the two groups to be as comparable as possible.

Dr. Bhatt noted that the FDA’s 2019 approval – given that the agency requires bioequivalence studies between branded and generic products – was enough to cause him to begin prescribing the generic inhaler. The fact that this approval was based on asthma but not also COPD is not a concern.

“There are so many similarities between asthma, COPD, and some obstructive lung diseases,” Dr. Bhatt noted.

In his experience, the only time someone with COPD continues using the branded inhaler – now that a potentially cheaper generic is available – is when their insurance plan makes their out-of-pocket cost minimal. Otherwise, brand loyalty does not exist.

“Patients are generally okay with being on a generic for inhalers, just because of the high cost,” Dr. Bhatt said.

The study was primarily supported by the National Heart, Lung, and Blood Institute. Dr. Feldman reported funding from Arnold Ventures, the Commonwealth Fund, and the FDA, and consulting relationships with Alosa Health and Aetion. Dr. Bhatt reported no relevant financial relationships.

*Correction, 8/16/23: An earlier version of this article mischaracterized Dr. Bhatt's comments on the availability of generic options.

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

Sometimes we get what we pay for. Other times we pay too much. 

That’s the message of a study published in Annals of Internal Medicine, which finds that a generic maintenance inhaler is as effective at managing symptoms of chronic obstructive pulmonary disorder (COPD) as a pricier branded alternative. 

In 2019, the Food and Drug Administration approved Wixela Inhub (the combination corticosteroid/long-acting beta² adrenergic agonist fluticasone-salmeterol; Viatris) as a generic dry powder inhaler for managing symptoms of COPD. This approval was based on evidence of the generic’s effectiveness against asthma, although COPD also was on the product label. The study authors compared Wixela’s effectiveness in controlling symptoms of COPD with that of the brand name inhaler Advair Diskus (fluticasone-salmeterol; GlaxoSmithKline), which uses the same active ingredients.

The result: “The generic looks to be as safe and effective as the brand name. I don’t see a clinical reason why one would ever need to get the brand name over the generic version,” said study author William Feldman, MD, DPhil, MPH, a health services researcher and pulmonologist at Harvard Medical School and Brigham and Women’s Hospital, both in Boston.
 

Same types of patients, different inhalers, same outcomes

Dr. Feldman and colleagues compared the medical records of 10,000 patients with COPD who began using the branded inhaler to the records of another 10,000 patients with COPD who opted for the generic alternative. Participants in the two groups were evenly matched by age, sex, race, and ethnicity, region, severity of COPD, and presence of other comorbidities, according to the researchers. Participants were all older than age 40, and the average age in both groups was 72 years.

The researchers looked for a difference in a first episode of a moderate exacerbation of COPD, defined as requiring a course of prednisone for 5-14 days. They also looked for cases of severe COPD exacerbation requiring hospitalization in the year after people began using either the generic or brand name inhaler. And they looked for differences across 1 year in rates of hospitalization for pneumonia.

For none of those outcomes, however, did the type of inhaler appear to matter. Compared with the brand-name drug, using the generic was associated with nearly identical rates of moderate or severe COPD exacerbation (hazard ratio, 0.97; 95% confidence interval, 0.90-1.04. The same was true for the proportion of people who went to the hospital for pneumonia at least once (HR, 0.99; 95% CI, 0.86-1.15).

“To get through the FDA as an interchangeable generic, the generic firms have to show that their product can be used in just the same way as the brand-name version,” Dr. Feldman said, which may explain why the generic and brand-name versions of the inhaler performed so similarly.

Dr. Feldman cautioned that the price savings for patients who opt for the generic over the branded product are hard to determine, given the vagaries of different insurance plans and potential rebates when using the branded project. As a general matter, having a single generic competitor will not lower costs much, Dr. Feldman noted, pointing to 2017 research from Harvard that found a profusion of generic competitors is needed to significantly lower health care costs.

“I don’t want to in any way underestimate the importance of getting that first generic onto the market, because it sets the stage for future generics,” Dr. Feldman said.  

“There are very few generic options for patients with COPD,” said Surya Bhatt, MD, director of the Pulmonary Function and Exercise Physiology Lab at the University of Alabama at Birmingham. Even the rescue inhalers that people with COPD use to manage acute episodes of the condition are usually branded at this time, Dr. Bhatt noted, with few generic options.*

“The results are quite compelling,” said Dr. Bhatt, who was not involved in the research. Although the trial was not randomized, he commended the researchers for stratifying participants in the two groups to be as comparable as possible.

Dr. Bhatt noted that the FDA’s 2019 approval – given that the agency requires bioequivalence studies between branded and generic products – was enough to cause him to begin prescribing the generic inhaler. The fact that this approval was based on asthma but not also COPD is not a concern.

“There are so many similarities between asthma, COPD, and some obstructive lung diseases,” Dr. Bhatt noted.

In his experience, the only time someone with COPD continues using the branded inhaler – now that a potentially cheaper generic is available – is when their insurance plan makes their out-of-pocket cost minimal. Otherwise, brand loyalty does not exist.

“Patients are generally okay with being on a generic for inhalers, just because of the high cost,” Dr. Bhatt said.

The study was primarily supported by the National Heart, Lung, and Blood Institute. Dr. Feldman reported funding from Arnold Ventures, the Commonwealth Fund, and the FDA, and consulting relationships with Alosa Health and Aetion. Dr. Bhatt reported no relevant financial relationships.

*Correction, 8/16/23: An earlier version of this article mischaracterized Dr. Bhatt's comments on the availability of generic options.

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

Ancestry was a significant predictor of response to lithium by adults with bipolar disorder (BPD), based on data from 172 individuals.

Lithium remains the first-line treatment for BPD, but clinical improvement occurs in less than one-third of patients, and factors that might affect response, especially genetic factors, have not been well studied, wrote Ana M. Díaz-Zuluaga, MD, of University of Antioquia, Medellín, Colombia, and colleagues.

Previous genetic research identified four linked single nucleotide polymorphisms (SNPs) in a single locus on chromosome 21 that were associated with lithium response, but the study was limited to individuals with European and Asian ancestry, the researchers said.

In a study published in the Journal of Affective Disorders, the researchers identified 172 adults aged 18 and older with a diagnosis of BPD I or II based on the DSM-IV-TR criteria. Participants had been taking lithium continuously for at least 6 months. Lithium response was defined using the Retrospective Criteria of Long-Term Treatment Response in Research Subjects with BD, also known as the Alda scale. Total Alda scale scores of 7 or higher indicated a responder phenotype; scores less than 7 were considered nonresponders.

Ancestry was determined using DNA samples and the software Structure Version 2.2, and participants were classified as Amerindian, African, or European.

The overall response rate to lithium was 15.11% (26 of 172 patients). In a univariate analysis, no significant differences emerged between responders and nonresponders in demographics or clinical characteristics. However, patients responsive to lithium were significantly less likely of African ancestry, compared with nonresponders (0.1 vs. 0.2, P = .005) and more likely of European ancestry (0.5 vs. 0.3, P = .024), and had fewer depressive episodes (2 vs. 3.9, P = .002). The difference in responders vs. nonresponders of Amerindian ancestry was not statistically significant (0.4 vs. 0.5, P = .204).

The researchers then used machine learning based on Advanced Recursive Partitioning Approaches (ARPAs) to create classification trees with and without ancestry components for predicting response to lithium. “Variable importance analysis shows that the most important predictor is the probability of Amerindian ancestry component, followed by the Amerindian and European ancestral components individual variances, and then by the African and European ancestry components,” the researchers wrote.

Without the ancestry component, the sensitivity and specificity for predicting a treatment response to lithium were 50% and 94.5% respectively, with an area under the curve of 72.2%.

“However, when ancestral components are included in the model, the sensitivity and specificity are 93 % and 84 %, respectively,” with an AUC of 89.2%, the researchers said.

Clinical predictors of treatment response included disease duration, number of depressive episodes, total number of affective episodes, and number of manic episodes.

The findings were limited by several factors including the cross-sectional design and potential impact of other psychotropic drugs, the researchers noted. A replication of the study in an independent dataset is needed to validate the findings, they said.

However, the study is the first known to explore the effect of ancestry on bipolar patients’ response to lithium, and suggests that ancestry components have potential predictive value in the clinical setting that could support a more personalized approach to treatment, the researchers said.

The study was supported by PRISMA U.T., Colciencias, Invitación 990 del 3 de Agosto de 2017, Código 111577757629, Contrato 781 de 2017; Convocatoria Programática Ciencias de la Salud 2014-2015 CODI-UdeA, and Convocatoria N.727-2015 Doctorados Nacionales, Colciencias, 2015. The researchers had no financial conflicts to disclose.

Ancestry was a significant predictor of response to lithium by adults with bipolar disorder (BPD), based on data from 172 individuals.

Lithium remains the first-line treatment for BPD, but clinical improvement occurs in less than one-third of patients, and factors that might affect response, especially genetic factors, have not been well studied, wrote Ana M. Díaz-Zuluaga, MD, of University of Antioquia, Medellín, Colombia, and colleagues.

Previous genetic research identified four linked single nucleotide polymorphisms (SNPs) in a single locus on chromosome 21 that were associated with lithium response, but the study was limited to individuals with European and Asian ancestry, the researchers said.

In a study published in the Journal of Affective Disorders, the researchers identified 172 adults aged 18 and older with a diagnosis of BPD I or II based on the DSM-IV-TR criteria. Participants had been taking lithium continuously for at least 6 months. Lithium response was defined using the Retrospective Criteria of Long-Term Treatment Response in Research Subjects with BD, also known as the Alda scale. Total Alda scale scores of 7 or higher indicated a responder phenotype; scores less than 7 were considered nonresponders.

Ancestry was determined using DNA samples and the software Structure Version 2.2, and participants were classified as Amerindian, African, or European.

The overall response rate to lithium was 15.11% (26 of 172 patients). In a univariate analysis, no significant differences emerged between responders and nonresponders in demographics or clinical characteristics. However, patients responsive to lithium were significantly less likely of African ancestry, compared with nonresponders (0.1 vs. 0.2, P = .005) and more likely of European ancestry (0.5 vs. 0.3, P = .024), and had fewer depressive episodes (2 vs. 3.9, P = .002). The difference in responders vs. nonresponders of Amerindian ancestry was not statistically significant (0.4 vs. 0.5, P = .204).

The researchers then used machine learning based on Advanced Recursive Partitioning Approaches (ARPAs) to create classification trees with and without ancestry components for predicting response to lithium. “Variable importance analysis shows that the most important predictor is the probability of Amerindian ancestry component, followed by the Amerindian and European ancestral components individual variances, and then by the African and European ancestry components,” the researchers wrote.

Without the ancestry component, the sensitivity and specificity for predicting a treatment response to lithium were 50% and 94.5% respectively, with an area under the curve of 72.2%.

“However, when ancestral components are included in the model, the sensitivity and specificity are 93 % and 84 %, respectively,” with an AUC of 89.2%, the researchers said.

Clinical predictors of treatment response included disease duration, number of depressive episodes, total number of affective episodes, and number of manic episodes.

The findings were limited by several factors including the cross-sectional design and potential impact of other psychotropic drugs, the researchers noted. A replication of the study in an independent dataset is needed to validate the findings, they said.

However, the study is the first known to explore the effect of ancestry on bipolar patients’ response to lithium, and suggests that ancestry components have potential predictive value in the clinical setting that could support a more personalized approach to treatment, the researchers said.

The study was supported by PRISMA U.T., Colciencias, Invitación 990 del 3 de Agosto de 2017, Código 111577757629, Contrato 781 de 2017; Convocatoria Programática Ciencias de la Salud 2014-2015 CODI-UdeA, and Convocatoria N.727-2015 Doctorados Nacionales, Colciencias, 2015. The researchers had no financial conflicts to disclose.

Ancestry was a significant predictor of response to lithium by adults with bipolar disorder (BPD), based on data from 172 individuals.

Lithium remains the first-line treatment for BPD, but clinical improvement occurs in less than one-third of patients, and factors that might affect response, especially genetic factors, have not been well studied, wrote Ana M. Díaz-Zuluaga, MD, of University of Antioquia, Medellín, Colombia, and colleagues.

Previous genetic research identified four linked single nucleotide polymorphisms (SNPs) in a single locus on chromosome 21 that were associated with lithium response, but the study was limited to individuals with European and Asian ancestry, the researchers said.

In a study published in the Journal of Affective Disorders, the researchers identified 172 adults aged 18 and older with a diagnosis of BPD I or II based on the DSM-IV-TR criteria. Participants had been taking lithium continuously for at least 6 months. Lithium response was defined using the Retrospective Criteria of Long-Term Treatment Response in Research Subjects with BD, also known as the Alda scale. Total Alda scale scores of 7 or higher indicated a responder phenotype; scores less than 7 were considered nonresponders.

Ancestry was determined using DNA samples and the software Structure Version 2.2, and participants were classified as Amerindian, African, or European.

The overall response rate to lithium was 15.11% (26 of 172 patients). In a univariate analysis, no significant differences emerged between responders and nonresponders in demographics or clinical characteristics. However, patients responsive to lithium were significantly less likely of African ancestry, compared with nonresponders (0.1 vs. 0.2, P = .005) and more likely of European ancestry (0.5 vs. 0.3, P = .024), and had fewer depressive episodes (2 vs. 3.9, P = .002). The difference in responders vs. nonresponders of Amerindian ancestry was not statistically significant (0.4 vs. 0.5, P = .204).

The researchers then used machine learning based on Advanced Recursive Partitioning Approaches (ARPAs) to create classification trees with and without ancestry components for predicting response to lithium. “Variable importance analysis shows that the most important predictor is the probability of Amerindian ancestry component, followed by the Amerindian and European ancestral components individual variances, and then by the African and European ancestry components,” the researchers wrote.

Without the ancestry component, the sensitivity and specificity for predicting a treatment response to lithium were 50% and 94.5% respectively, with an area under the curve of 72.2%.

“However, when ancestral components are included in the model, the sensitivity and specificity are 93 % and 84 %, respectively,” with an AUC of 89.2%, the researchers said.

Clinical predictors of treatment response included disease duration, number of depressive episodes, total number of affective episodes, and number of manic episodes.

The findings were limited by several factors including the cross-sectional design and potential impact of other psychotropic drugs, the researchers noted. A replication of the study in an independent dataset is needed to validate the findings, they said.

However, the study is the first known to explore the effect of ancestry on bipolar patients’ response to lithium, and suggests that ancestry components have potential predictive value in the clinical setting that could support a more personalized approach to treatment, the researchers said.

The study was supported by PRISMA U.T., Colciencias, Invitación 990 del 3 de Agosto de 2017, Código 111577757629, Contrato 781 de 2017; Convocatoria Programática Ciencias de la Salud 2014-2015 CODI-UdeA, and Convocatoria N.727-2015 Doctorados Nacionales, Colciencias, 2015. The researchers had no financial conflicts to disclose.

The popular but expensive weight loss drug semaglutide (Wegovy, significantly reduced major adverse cardiovascular events (MACE) by 20% when given to patients, compared with those receiving placebo, in the pivotal SELECT trial, with more than 17,000 enrolled people with overweight or obesity and established cardiovascular disease (CVD), but no diabetes.

The finding should fuel improved patient access to this glucagon-like peptide-1 (GLP-1) agonist weight-loss agent that has historically been hindered by skepticism among U.S. payers, many of whom have criticized the health benefits and cost effectiveness of this drug in people whose only indication for treatment is overweight or obesity.

According to top-line results from SELECT released by Novo Nordisk on Aug. 8, the people randomly assigned to receive weekly 2.4-mg subcutaneous injections of semaglutide showed a significant 20% reduction in their incidence of the combined endpoint of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. The announcement added that semaglutide treatment also significantly linked with a drop in the incidence of each of these individual three endpoints; the magnitude of these reductions, however, wasn’t specified, nor was the duration of treatment and follow-up.

The results also showed a level of safety and patient tolerance for weekly 2.4-mg injections of semaglutide that were consistent with prior reports on the agent. Semaglutide as Wegovy received marketing approval from the U.S. Food and Drug Administration in 2021 for weight loss, and in 2017 for glucose control in people with type 2 diabetes, at a weekly maximum dose of 2.0 mg (for which it’s marketed as Ozempic).

SELECT began in 2018 and randomly assigned 17,604 adults aged 45 years and older at more than 800 sites in 41 countries. The company’s announcement noted that the trial had accrued a total of 1,270 study participants with a first MACE event but did not break this total down based on treatment received.
 

‘A good result for patients’

“The topline results from SELECT are exciting, as preventing heart attacks and stroke with a drug that also lowers weight is very important for many patients, especially if the data also show – as I suspect they will – a meaningful improvement of quality of life for patients due to associated weight loss,” commented Naveed Sattar, PhD, a professor of metabolic medicine at the University of Glasgow who was not involved with the study.

Changing how obesity is regarded

“To date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke, or cardiovascular death,” said Martin Holst Lange, executive vice president for development at Novo Nordisk, in the company’s press release.

“SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated.”

Several of the early medical options for aiding weight loss had substantial adverse effects, including increased MACE rates, a history that led to pervasive wariness among physicians over the safety of antiobesity agents and the wisdom of using medically aided weight loss to produce health benefits.

This attitude also helped dampen health insurance coverage of weight-loss treatments. For example, Medicare has a long-standing policy against reimbursing the cost for medications that are used for the indication of weight loss, and a 2003 U.S. law prohibited part D plans from providing this coverage.

Semaglutide belongs to the class of agents that mimic the action of the incretin GLP-1. The introduction of this class of GLP-1 agonists for weight loss began in 2014 with the FDA’s approval of liraglutide (Saxenda), a daily subcutaneous injection that marked the first step toward establishing the class as safe and effective for weight loss and launching a new era in weight-loss treatment.

According to the Novo Nordisk announcement, a full report on results from SELECT will occur “at a scientific meeting later in 2023.”

SELECT is sponsored by Novo Nordisk, the company that markets semaglutide (Wegovy). Dr. Sattar is a consultant to several companies that market GLP-1 receptor agonists, including Novo Nordisk and Lilly, but has had no involvement in SELECT.

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

The popular but expensive weight loss drug semaglutide (Wegovy, significantly reduced major adverse cardiovascular events (MACE) by 20% when given to patients, compared with those receiving placebo, in the pivotal SELECT trial, with more than 17,000 enrolled people with overweight or obesity and established cardiovascular disease (CVD), but no diabetes.

The finding should fuel improved patient access to this glucagon-like peptide-1 (GLP-1) agonist weight-loss agent that has historically been hindered by skepticism among U.S. payers, many of whom have criticized the health benefits and cost effectiveness of this drug in people whose only indication for treatment is overweight or obesity.

According to top-line results from SELECT released by Novo Nordisk on Aug. 8, the people randomly assigned to receive weekly 2.4-mg subcutaneous injections of semaglutide showed a significant 20% reduction in their incidence of the combined endpoint of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. The announcement added that semaglutide treatment also significantly linked with a drop in the incidence of each of these individual three endpoints; the magnitude of these reductions, however, wasn’t specified, nor was the duration of treatment and follow-up.

The results also showed a level of safety and patient tolerance for weekly 2.4-mg injections of semaglutide that were consistent with prior reports on the agent. Semaglutide as Wegovy received marketing approval from the U.S. Food and Drug Administration in 2021 for weight loss, and in 2017 for glucose control in people with type 2 diabetes, at a weekly maximum dose of 2.0 mg (for which it’s marketed as Ozempic).

SELECT began in 2018 and randomly assigned 17,604 adults aged 45 years and older at more than 800 sites in 41 countries. The company’s announcement noted that the trial had accrued a total of 1,270 study participants with a first MACE event but did not break this total down based on treatment received.
 

‘A good result for patients’

“The topline results from SELECT are exciting, as preventing heart attacks and stroke with a drug that also lowers weight is very important for many patients, especially if the data also show – as I suspect they will – a meaningful improvement of quality of life for patients due to associated weight loss,” commented Naveed Sattar, PhD, a professor of metabolic medicine at the University of Glasgow who was not involved with the study.

Changing how obesity is regarded

“To date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke, or cardiovascular death,” said Martin Holst Lange, executive vice president for development at Novo Nordisk, in the company’s press release.

“SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated.”

Several of the early medical options for aiding weight loss had substantial adverse effects, including increased MACE rates, a history that led to pervasive wariness among physicians over the safety of antiobesity agents and the wisdom of using medically aided weight loss to produce health benefits.

This attitude also helped dampen health insurance coverage of weight-loss treatments. For example, Medicare has a long-standing policy against reimbursing the cost for medications that are used for the indication of weight loss, and a 2003 U.S. law prohibited part D plans from providing this coverage.

Semaglutide belongs to the class of agents that mimic the action of the incretin GLP-1. The introduction of this class of GLP-1 agonists for weight loss began in 2014 with the FDA’s approval of liraglutide (Saxenda), a daily subcutaneous injection that marked the first step toward establishing the class as safe and effective for weight loss and launching a new era in weight-loss treatment.

According to the Novo Nordisk announcement, a full report on results from SELECT will occur “at a scientific meeting later in 2023.”

SELECT is sponsored by Novo Nordisk, the company that markets semaglutide (Wegovy). Dr. Sattar is a consultant to several companies that market GLP-1 receptor agonists, including Novo Nordisk and Lilly, but has had no involvement in SELECT.

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

The popular but expensive weight loss drug semaglutide (Wegovy, significantly reduced major adverse cardiovascular events (MACE) by 20% when given to patients, compared with those receiving placebo, in the pivotal SELECT trial, with more than 17,000 enrolled people with overweight or obesity and established cardiovascular disease (CVD), but no diabetes.

The finding should fuel improved patient access to this glucagon-like peptide-1 (GLP-1) agonist weight-loss agent that has historically been hindered by skepticism among U.S. payers, many of whom have criticized the health benefits and cost effectiveness of this drug in people whose only indication for treatment is overweight or obesity.

According to top-line results from SELECT released by Novo Nordisk on Aug. 8, the people randomly assigned to receive weekly 2.4-mg subcutaneous injections of semaglutide showed a significant 20% reduction in their incidence of the combined endpoint of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. The announcement added that semaglutide treatment also significantly linked with a drop in the incidence of each of these individual three endpoints; the magnitude of these reductions, however, wasn’t specified, nor was the duration of treatment and follow-up.

The results also showed a level of safety and patient tolerance for weekly 2.4-mg injections of semaglutide that were consistent with prior reports on the agent. Semaglutide as Wegovy received marketing approval from the U.S. Food and Drug Administration in 2021 for weight loss, and in 2017 for glucose control in people with type 2 diabetes, at a weekly maximum dose of 2.0 mg (for which it’s marketed as Ozempic).

SELECT began in 2018 and randomly assigned 17,604 adults aged 45 years and older at more than 800 sites in 41 countries. The company’s announcement noted that the trial had accrued a total of 1,270 study participants with a first MACE event but did not break this total down based on treatment received.
 

‘A good result for patients’

“The topline results from SELECT are exciting, as preventing heart attacks and stroke with a drug that also lowers weight is very important for many patients, especially if the data also show – as I suspect they will – a meaningful improvement of quality of life for patients due to associated weight loss,” commented Naveed Sattar, PhD, a professor of metabolic medicine at the University of Glasgow who was not involved with the study.

Changing how obesity is regarded

“To date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke, or cardiovascular death,” said Martin Holst Lange, executive vice president for development at Novo Nordisk, in the company’s press release.

“SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated.”

Several of the early medical options for aiding weight loss had substantial adverse effects, including increased MACE rates, a history that led to pervasive wariness among physicians over the safety of antiobesity agents and the wisdom of using medically aided weight loss to produce health benefits.

This attitude also helped dampen health insurance coverage of weight-loss treatments. For example, Medicare has a long-standing policy against reimbursing the cost for medications that are used for the indication of weight loss, and a 2003 U.S. law prohibited part D plans from providing this coverage.

Semaglutide belongs to the class of agents that mimic the action of the incretin GLP-1. The introduction of this class of GLP-1 agonists for weight loss began in 2014 with the FDA’s approval of liraglutide (Saxenda), a daily subcutaneous injection that marked the first step toward establishing the class as safe and effective for weight loss and launching a new era in weight-loss treatment.

According to the Novo Nordisk announcement, a full report on results from SELECT will occur “at a scientific meeting later in 2023.”

SELECT is sponsored by Novo Nordisk, the company that markets semaglutide (Wegovy). Dr. Sattar is a consultant to several companies that market GLP-1 receptor agonists, including Novo Nordisk and Lilly, but has had no involvement in SELECT.

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

Until the 19th century there was nothing even resembling our current conception of the medical record. A few physicians may have kept personal notes, observations, and some sketches of their patients primarily to be used in teaching medical students or as part of their own curiosity-driven research. However, around 1800 the Governor Council of the State of New York adopted a proposition that all home doctors should register their medical cases again to be used as an educational tool. By 1830 these registries became annual reporting requirements that included admissions and discharges, treatment results, and expenditures. It shouldn’t surprise you learn that a review of these entries could be linked to a doctor’s prospects for promotion.

In 1919 the American College of Surgeons attempted to standardize its members’ “treatment diaries” to look something more like our current medical records with a history, lab tests, diagnosis, treatment plan, and something akin to daily progress notes. However, as late as the 1970s, when I began primary care practice, there were very few dictates on what our office notes should contain. A few (not including myself) had been trained to use a S.O.A.P. format (Subjective, Objective, Assessment, and Plan) to organize their observations. Back then I viewed my office records as primarily a mnemonic device and only because I had a partner did I make any passing attempt at legibility.

With AI staring us in the face and threatening to expand what has become an already bloated medical record, it may be time to reconsider the purpose of the medical record.

Although there was a time when a doctor’s notes simply functioned as a mnemonic, few physicians today practice in isolation and their records must now serve as a vehicle to communicate with covering physicians and consultants.

How detailed do those notes need to be? Do we need more than the hard data – the numbers, the prescriptions, the biometrics, the chronology of the patient’s procedures? As a covering physician or consultant, I’m not really that interested in your subjective observations. It’s not that I don’t trust you, but like any good physician I’m going to take my own history directly from the patient and do my own physical exam. You may have missed something and I owe the patient a fresh look and listen before I render an opinion or prescribe a management plan.

The medical record has become a detailed invoice to be attached to your bill to third-party payers. You need to prove to them that your service has some value. It’s not that the third-party payers don’t trust you ... well maybe that’s the issue. They don’t. So you have to prove to them that you really did something. Since they weren’t in the exam room, you must document that you asked the patient questions, did a thorough exam, and spent a specified amount of time at it. Of course that assumes that there is a direct correlation between the amount of time you spent with the patient and the quality of care. Which isn’t always the case. One sentence merely stating that you are a well-trained professional and did a thorough job doesn’t seem to be good enough. It works for the plumber and the electrician. But again, it’s that trust thing.

Of course there are the licensing and certification organizations that have a legitimate interest in the quality of your work. Because having an observer following you around for a day or two is impractical (which I still think is a good idea), you need to include evidence in your chart that you practice the standard of care by following accepted screening measures and treating according to standard guidelines.

And finally, while we are talking about trust, there is the whole risk management thing – maybe the most potent inflater of medical records. The lawyer-promoted myth “if you didn’t document it, it didn’t happen” encourages doctors to use voluminous verbiage merely to give your lawyer ammunition when you find yourself in a he-said/she-said situation.

Of course all of this needs to be carefully worded because the patient now has and deserves the right to review his or her medical records. And this might be the only good news. AI can be taught to create a medical record that is complete and more easily read and digested by the patient. This could make the records even more voluminous and as more patients become familiar with their own health records they may begin to demand that they become more concise and actually reflect what went on in the visit.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

Until the 19th century there was nothing even resembling our current conception of the medical record. A few physicians may have kept personal notes, observations, and some sketches of their patients primarily to be used in teaching medical students or as part of their own curiosity-driven research. However, around 1800 the Governor Council of the State of New York adopted a proposition that all home doctors should register their medical cases again to be used as an educational tool. By 1830 these registries became annual reporting requirements that included admissions and discharges, treatment results, and expenditures. It shouldn’t surprise you learn that a review of these entries could be linked to a doctor’s prospects for promotion.

In 1919 the American College of Surgeons attempted to standardize its members’ “treatment diaries” to look something more like our current medical records with a history, lab tests, diagnosis, treatment plan, and something akin to daily progress notes. However, as late as the 1970s, when I began primary care practice, there were very few dictates on what our office notes should contain. A few (not including myself) had been trained to use a S.O.A.P. format (Subjective, Objective, Assessment, and Plan) to organize their observations. Back then I viewed my office records as primarily a mnemonic device and only because I had a partner did I make any passing attempt at legibility.

With AI staring us in the face and threatening to expand what has become an already bloated medical record, it may be time to reconsider the purpose of the medical record.

Although there was a time when a doctor’s notes simply functioned as a mnemonic, few physicians today practice in isolation and their records must now serve as a vehicle to communicate with covering physicians and consultants.

How detailed do those notes need to be? Do we need more than the hard data – the numbers, the prescriptions, the biometrics, the chronology of the patient’s procedures? As a covering physician or consultant, I’m not really that interested in your subjective observations. It’s not that I don’t trust you, but like any good physician I’m going to take my own history directly from the patient and do my own physical exam. You may have missed something and I owe the patient a fresh look and listen before I render an opinion or prescribe a management plan.

The medical record has become a detailed invoice to be attached to your bill to third-party payers. You need to prove to them that your service has some value. It’s not that the third-party payers don’t trust you ... well maybe that’s the issue. They don’t. So you have to prove to them that you really did something. Since they weren’t in the exam room, you must document that you asked the patient questions, did a thorough exam, and spent a specified amount of time at it. Of course that assumes that there is a direct correlation between the amount of time you spent with the patient and the quality of care. Which isn’t always the case. One sentence merely stating that you are a well-trained professional and did a thorough job doesn’t seem to be good enough. It works for the plumber and the electrician. But again, it’s that trust thing.

Of course there are the licensing and certification organizations that have a legitimate interest in the quality of your work. Because having an observer following you around for a day or two is impractical (which I still think is a good idea), you need to include evidence in your chart that you practice the standard of care by following accepted screening measures and treating according to standard guidelines.

And finally, while we are talking about trust, there is the whole risk management thing – maybe the most potent inflater of medical records. The lawyer-promoted myth “if you didn’t document it, it didn’t happen” encourages doctors to use voluminous verbiage merely to give your lawyer ammunition when you find yourself in a he-said/she-said situation.

Of course all of this needs to be carefully worded because the patient now has and deserves the right to review his or her medical records. And this might be the only good news. AI can be taught to create a medical record that is complete and more easily read and digested by the patient. This could make the records even more voluminous and as more patients become familiar with their own health records they may begin to demand that they become more concise and actually reflect what went on in the visit.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

Until the 19th century there was nothing even resembling our current conception of the medical record. A few physicians may have kept personal notes, observations, and some sketches of their patients primarily to be used in teaching medical students or as part of their own curiosity-driven research. However, around 1800 the Governor Council of the State of New York adopted a proposition that all home doctors should register their medical cases again to be used as an educational tool. By 1830 these registries became annual reporting requirements that included admissions and discharges, treatment results, and expenditures. It shouldn’t surprise you learn that a review of these entries could be linked to a doctor’s prospects for promotion.

In 1919 the American College of Surgeons attempted to standardize its members’ “treatment diaries” to look something more like our current medical records with a history, lab tests, diagnosis, treatment plan, and something akin to daily progress notes. However, as late as the 1970s, when I began primary care practice, there were very few dictates on what our office notes should contain. A few (not including myself) had been trained to use a S.O.A.P. format (Subjective, Objective, Assessment, and Plan) to organize their observations. Back then I viewed my office records as primarily a mnemonic device and only because I had a partner did I make any passing attempt at legibility.

With AI staring us in the face and threatening to expand what has become an already bloated medical record, it may be time to reconsider the purpose of the medical record.

Although there was a time when a doctor’s notes simply functioned as a mnemonic, few physicians today practice in isolation and their records must now serve as a vehicle to communicate with covering physicians and consultants.

How detailed do those notes need to be? Do we need more than the hard data – the numbers, the prescriptions, the biometrics, the chronology of the patient’s procedures? As a covering physician or consultant, I’m not really that interested in your subjective observations. It’s not that I don’t trust you, but like any good physician I’m going to take my own history directly from the patient and do my own physical exam. You may have missed something and I owe the patient a fresh look and listen before I render an opinion or prescribe a management plan.

The medical record has become a detailed invoice to be attached to your bill to third-party payers. You need to prove to them that your service has some value. It’s not that the third-party payers don’t trust you ... well maybe that’s the issue. They don’t. So you have to prove to them that you really did something. Since they weren’t in the exam room, you must document that you asked the patient questions, did a thorough exam, and spent a specified amount of time at it. Of course that assumes that there is a direct correlation between the amount of time you spent with the patient and the quality of care. Which isn’t always the case. One sentence merely stating that you are a well-trained professional and did a thorough job doesn’t seem to be good enough. It works for the plumber and the electrician. But again, it’s that trust thing.

Of course there are the licensing and certification organizations that have a legitimate interest in the quality of your work. Because having an observer following you around for a day or two is impractical (which I still think is a good idea), you need to include evidence in your chart that you practice the standard of care by following accepted screening measures and treating according to standard guidelines.

And finally, while we are talking about trust, there is the whole risk management thing – maybe the most potent inflater of medical records. The lawyer-promoted myth “if you didn’t document it, it didn’t happen” encourages doctors to use voluminous verbiage merely to give your lawyer ammunition when you find yourself in a he-said/she-said situation.

Of course all of this needs to be carefully worded because the patient now has and deserves the right to review his or her medical records. And this might be the only good news. AI can be taught to create a medical record that is complete and more easily read and digested by the patient. This could make the records even more voluminous and as more patients become familiar with their own health records they may begin to demand that they become more concise and actually reflect what went on in the visit.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

Zolpidem (Ambien) is a well-known sedative for sleep. Letairis (Ambrisentan) is a vasodilator for the treatment of pulmonary arterial hypertension. Citalopram (Celexa) is an antidepressant; escitalopram (Lexapro) is prescribed for anxiety and depression.
 

Those are just 4 of the more than 80 pairs of drug names that the Institute for Safe Medication Practices recently added to its list of confusing drug names. The aim is to increase awareness about the potential for a serious medication mistake when the wrong drug is given because of drug names that look and sound similar.

Awareness of these drug names, however, is just the first step in preventing medication mistakes. Health care providers should take a number of other steps as well, experts said.

ISMP launched its confusing drug names list, previously called look-alike, sound-alike (LASA) drugs, in 2008. The new list is an update of the 2019 version, said Michael J. Gaunt, PharmD, senior manager of error reporting programs for the ISMP, which focuses on the prevention of medication mistakes. The new entries were chosen on the basis of a number of factors, including ISMP’s analysis of recent medication mishap reports that were submitted to it.

The ISMP list now includes about 528 drug pairs, Dr. Gaunt said. The list is long, he said, partly because each pair is listed twice, so readers can cross reference. For instance, hydralazine and hydroxyzine are listed in one entry in the list, and hydroxyzine and hydralazine are listed in another.

Brand Institute in Miami has named, among other drugs, Entresto, Rybelsus, and Lunesta. The regulatory arm of the company, the Drug Safety Institute, “considers drug names that have been confused as an important part of our comprehensive drug name assessments,” Todd Bridges, global president of the institute, said in an emailed statement. Information on the confusing drug names are incorporated into the company’s proprietary algorithm and is used when developing brand names for drugs. “We continually update this algorithm as new drug names that are often confused are identified,” Mr. Bridges said.
 

Confusing drug names: Ongoing issue

The length of the list, as well as the latest additions, are not surprising, said Mary Ann Kliethermes, PharmD, director of medication safety and quality for the American Society of Health-System Pharmacists, a membership organization of about 60,000 pharmacists who practice in inpatient and outpatient settings.

“I’ve been in practice over 45 years,” she said, “and this has been a problem ever since I have been in practice.” The sheer volume of new drugs is one reason, she said. From 2013 through 2022, the U.S. Food and Drug Administration approved an average of 43 novel drugs per year, according to a report from its Center for Drug Evaluation and Research. “Since the 90s, this [confusion about similar drug names] has happened,” Dr. Kliethermes said.

According to a 2023 report, about 7,000-9,000 people die each year in the United States as the result of a medication error. However, it’s impossible to say for sure what percentage of those errors involve name confusion, Dr. Gaunt said.

Not all the mistakes are reported. Some that are reported are dramatic and deadly. In 2022, a Tennessee nurse was convicted of gross neglect and negligent homicide. She was sentenced to 3 years’ probation after she mistakenly gave vercuronium, an anesthetic agent, instead of the sedative Versed to a patient, and the woman died.
 

Updated list: A closer look

Many of the new drug pairs that are listed in the update are cephalosporins, said Dr. Kliethermes, who reviewed the new list for this news organization. In all, 20 of the latest 82 additions are cephalosporins. These include drugs such as cefazolin, which can be confused with cefotetan, and vice versa. These drugs have been around since the 1980s, she said, but “they needed to be on there.” Even in the 1980s, it was becoming difficult to differentiate them, and there were fewer drugs in that class then, she said.

Influenza vaccines made the new list, too. Fluzone High-Dose Quadrivalent can be confused with fluzone quadrivalent. Other new additions: hydrochlorothiazide and hydroxychloroquine, Lasik and Wakix, Pitressin and Pitocin, Remeron and Rozerem.
 

Beyond the list

While it’s not possible to pinpoint how big a problem name confusion is in causing medication mistakes, “it is certainly still an issue,” Dr. Gaunt said. A variety of practices can reduce that risk substantially, Dr. Gaunt and Dr. Kliethermes agreed.

Tall-man lettering. Both the FDA and the ISMP recommend the use of so-called tall-man lettering (TML), which involves the use of uppercase letters, sometimes in boldface, to distinguish similar names on product labels and elsewhere. Examples include vinBLAStine and vinCRIStine.

Electronic prescribing. “It eliminates the risk of handwriting confusion,” Dr. Gaunt said. However, electronic prescribing can have a downside, Dr. Kliethermes said. When ordering medication, a person may type in a few letters and may then be presented with a prompt that lists several drug names, and it can be easy to click the wrong one. For that reason, ISMP and other experts recommend typing at least five letters when searching for a medication in an electronic system.

Use both brand and generic names on labels and prescriptions.

Write the indication. That can serve as a double check. If a prescription for Ambien says “For sleep,” there’s probably less risk of filling a prescription for ambrisentan, the vasodilator.

Smart formulary additions. When hospitals add medications to their formularies, “part of that formulary assessment should include looking at the potential risk for errors,” Dr. Gaunt said. This involves keeping an eye out for confusing names and similar packaging. “Do that analysis up front and put in strategies to minimize that. Maybe you look for a different drug [for the same use] that has a different name.” Or choose a different manufacturer, so the medication would at least have a different container.

Use bar code scanning. Suppose a pharmacist goes to the shelf and pulls the wrong drug. “Bar code scanning provides the opportunity to catch the error,” Dr. Gaunt said. Many community pharmacies now have bar code scanning. ISMP just issued best practices for community pharmacies, Dr. Gaunt said, and these include the use of bar code scanning and other measures.

Educate consumers. Health care providers can educate consumers on how to minimize the risk of getting the wrong drug, Dr. Gaunt said. When patients are picking up a prescription, suggest they look at the container label; if it looks different from previous prescriptions of the same medicine, ask the pharmacist for an explanation. Some patients just pass it off, Dr. Gaunt said, figuring the pharmacist or health plan switched manufacturers of their medication.

Access the list. The entire list is on the ISMP site and is accessible after free registration.
 

Goal: Preventing confusion

The FDA has provided guidance for industry on naming drugs not yet approved so that the proposed names are not too similar in sound or appearance to those already on the market. Included in the lengthy document are checklists, such as, “Across a range of dialects, are the names consistently pronounced differently?” and “Are the lengths of the names dissimilar when scripted?” (Lengths are considered different if they differ by two or more letters.)

The FDA also offers the phonetic and orthographic computer analysis (POCA) program, a software tool that employs an advanced algorithm to evaluate similarities between two drug names. The data sources are updated regularly as new drugs are approved.
 

Liability update

The problem may be decreasing. In a 2020 report, researchers used pharmacists’ professional liability claim data from the Healthcare Providers Service Organization. They compared 2018 data on claims with 2013 data. The percentage of claims associated with wrong drug dispensing errors declined from 43.8% in 2013 to 36.8% in 2018. Wrong dose claims also declined, from 31.5% to 15.3%.

These researchers concluded that technology and automation have contributed to the prevention of medication errors caused by the use of the wrong drug and the wrong dose, but mistakes continue, owing to system and human errors.

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

Zolpidem (Ambien) is a well-known sedative for sleep. Letairis (Ambrisentan) is a vasodilator for the treatment of pulmonary arterial hypertension. Citalopram (Celexa) is an antidepressant; escitalopram (Lexapro) is prescribed for anxiety and depression.
 

Those are just 4 of the more than 80 pairs of drug names that the Institute for Safe Medication Practices recently added to its list of confusing drug names. The aim is to increase awareness about the potential for a serious medication mistake when the wrong drug is given because of drug names that look and sound similar.

Awareness of these drug names, however, is just the first step in preventing medication mistakes. Health care providers should take a number of other steps as well, experts said.

ISMP launched its confusing drug names list, previously called look-alike, sound-alike (LASA) drugs, in 2008. The new list is an update of the 2019 version, said Michael J. Gaunt, PharmD, senior manager of error reporting programs for the ISMP, which focuses on the prevention of medication mistakes. The new entries were chosen on the basis of a number of factors, including ISMP’s analysis of recent medication mishap reports that were submitted to it.

The ISMP list now includes about 528 drug pairs, Dr. Gaunt said. The list is long, he said, partly because each pair is listed twice, so readers can cross reference. For instance, hydralazine and hydroxyzine are listed in one entry in the list, and hydroxyzine and hydralazine are listed in another.

Brand Institute in Miami has named, among other drugs, Entresto, Rybelsus, and Lunesta. The regulatory arm of the company, the Drug Safety Institute, “considers drug names that have been confused as an important part of our comprehensive drug name assessments,” Todd Bridges, global president of the institute, said in an emailed statement. Information on the confusing drug names are incorporated into the company’s proprietary algorithm and is used when developing brand names for drugs. “We continually update this algorithm as new drug names that are often confused are identified,” Mr. Bridges said.
 

Confusing drug names: Ongoing issue

The length of the list, as well as the latest additions, are not surprising, said Mary Ann Kliethermes, PharmD, director of medication safety and quality for the American Society of Health-System Pharmacists, a membership organization of about 60,000 pharmacists who practice in inpatient and outpatient settings.

“I’ve been in practice over 45 years,” she said, “and this has been a problem ever since I have been in practice.” The sheer volume of new drugs is one reason, she said. From 2013 through 2022, the U.S. Food and Drug Administration approved an average of 43 novel drugs per year, according to a report from its Center for Drug Evaluation and Research. “Since the 90s, this [confusion about similar drug names] has happened,” Dr. Kliethermes said.

According to a 2023 report, about 7,000-9,000 people die each year in the United States as the result of a medication error. However, it’s impossible to say for sure what percentage of those errors involve name confusion, Dr. Gaunt said.

Not all the mistakes are reported. Some that are reported are dramatic and deadly. In 2022, a Tennessee nurse was convicted of gross neglect and negligent homicide. She was sentenced to 3 years’ probation after she mistakenly gave vercuronium, an anesthetic agent, instead of the sedative Versed to a patient, and the woman died.
 

Updated list: A closer look

Many of the new drug pairs that are listed in the update are cephalosporins, said Dr. Kliethermes, who reviewed the new list for this news organization. In all, 20 of the latest 82 additions are cephalosporins. These include drugs such as cefazolin, which can be confused with cefotetan, and vice versa. These drugs have been around since the 1980s, she said, but “they needed to be on there.” Even in the 1980s, it was becoming difficult to differentiate them, and there were fewer drugs in that class then, she said.

Influenza vaccines made the new list, too. Fluzone High-Dose Quadrivalent can be confused with fluzone quadrivalent. Other new additions: hydrochlorothiazide and hydroxychloroquine, Lasik and Wakix, Pitressin and Pitocin, Remeron and Rozerem.
 

Beyond the list

While it’s not possible to pinpoint how big a problem name confusion is in causing medication mistakes, “it is certainly still an issue,” Dr. Gaunt said. A variety of practices can reduce that risk substantially, Dr. Gaunt and Dr. Kliethermes agreed.

Tall-man lettering. Both the FDA and the ISMP recommend the use of so-called tall-man lettering (TML), which involves the use of uppercase letters, sometimes in boldface, to distinguish similar names on product labels and elsewhere. Examples include vinBLAStine and vinCRIStine.

Electronic prescribing. “It eliminates the risk of handwriting confusion,” Dr. Gaunt said. However, electronic prescribing can have a downside, Dr. Kliethermes said. When ordering medication, a person may type in a few letters and may then be presented with a prompt that lists several drug names, and it can be easy to click the wrong one. For that reason, ISMP and other experts recommend typing at least five letters when searching for a medication in an electronic system.

Use both brand and generic names on labels and prescriptions.

Write the indication. That can serve as a double check. If a prescription for Ambien says “For sleep,” there’s probably less risk of filling a prescription for ambrisentan, the vasodilator.

Smart formulary additions. When hospitals add medications to their formularies, “part of that formulary assessment should include looking at the potential risk for errors,” Dr. Gaunt said. This involves keeping an eye out for confusing names and similar packaging. “Do that analysis up front and put in strategies to minimize that. Maybe you look for a different drug [for the same use] that has a different name.” Or choose a different manufacturer, so the medication would at least have a different container.

Use bar code scanning. Suppose a pharmacist goes to the shelf and pulls the wrong drug. “Bar code scanning provides the opportunity to catch the error,” Dr. Gaunt said. Many community pharmacies now have bar code scanning. ISMP just issued best practices for community pharmacies, Dr. Gaunt said, and these include the use of bar code scanning and other measures.

Educate consumers. Health care providers can educate consumers on how to minimize the risk of getting the wrong drug, Dr. Gaunt said. When patients are picking up a prescription, suggest they look at the container label; if it looks different from previous prescriptions of the same medicine, ask the pharmacist for an explanation. Some patients just pass it off, Dr. Gaunt said, figuring the pharmacist or health plan switched manufacturers of their medication.

Access the list. The entire list is on the ISMP site and is accessible after free registration.
 

Goal: Preventing confusion

The FDA has provided guidance for industry on naming drugs not yet approved so that the proposed names are not too similar in sound or appearance to those already on the market. Included in the lengthy document are checklists, such as, “Across a range of dialects, are the names consistently pronounced differently?” and “Are the lengths of the names dissimilar when scripted?” (Lengths are considered different if they differ by two or more letters.)

The FDA also offers the phonetic and orthographic computer analysis (POCA) program, a software tool that employs an advanced algorithm to evaluate similarities between two drug names. The data sources are updated regularly as new drugs are approved.
 

Liability update

The problem may be decreasing. In a 2020 report, researchers used pharmacists’ professional liability claim data from the Healthcare Providers Service Organization. They compared 2018 data on claims with 2013 data. The percentage of claims associated with wrong drug dispensing errors declined from 43.8% in 2013 to 36.8% in 2018. Wrong dose claims also declined, from 31.5% to 15.3%.

These researchers concluded that technology and automation have contributed to the prevention of medication errors caused by the use of the wrong drug and the wrong dose, but mistakes continue, owing to system and human errors.

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

Zolpidem (Ambien) is a well-known sedative for sleep. Letairis (Ambrisentan) is a vasodilator for the treatment of pulmonary arterial hypertension. Citalopram (Celexa) is an antidepressant; escitalopram (Lexapro) is prescribed for anxiety and depression.
 

Those are just 4 of the more than 80 pairs of drug names that the Institute for Safe Medication Practices recently added to its list of confusing drug names. The aim is to increase awareness about the potential for a serious medication mistake when the wrong drug is given because of drug names that look and sound similar.

Awareness of these drug names, however, is just the first step in preventing medication mistakes. Health care providers should take a number of other steps as well, experts said.

ISMP launched its confusing drug names list, previously called look-alike, sound-alike (LASA) drugs, in 2008. The new list is an update of the 2019 version, said Michael J. Gaunt, PharmD, senior manager of error reporting programs for the ISMP, which focuses on the prevention of medication mistakes. The new entries were chosen on the basis of a number of factors, including ISMP’s analysis of recent medication mishap reports that were submitted to it.

The ISMP list now includes about 528 drug pairs, Dr. Gaunt said. The list is long, he said, partly because each pair is listed twice, so readers can cross reference. For instance, hydralazine and hydroxyzine are listed in one entry in the list, and hydroxyzine and hydralazine are listed in another.

Brand Institute in Miami has named, among other drugs, Entresto, Rybelsus, and Lunesta. The regulatory arm of the company, the Drug Safety Institute, “considers drug names that have been confused as an important part of our comprehensive drug name assessments,” Todd Bridges, global president of the institute, said in an emailed statement. Information on the confusing drug names are incorporated into the company’s proprietary algorithm and is used when developing brand names for drugs. “We continually update this algorithm as new drug names that are often confused are identified,” Mr. Bridges said.
 

Confusing drug names: Ongoing issue

The length of the list, as well as the latest additions, are not surprising, said Mary Ann Kliethermes, PharmD, director of medication safety and quality for the American Society of Health-System Pharmacists, a membership organization of about 60,000 pharmacists who practice in inpatient and outpatient settings.

“I’ve been in practice over 45 years,” she said, “and this has been a problem ever since I have been in practice.” The sheer volume of new drugs is one reason, she said. From 2013 through 2022, the U.S. Food and Drug Administration approved an average of 43 novel drugs per year, according to a report from its Center for Drug Evaluation and Research. “Since the 90s, this [confusion about similar drug names] has happened,” Dr. Kliethermes said.

According to a 2023 report, about 7,000-9,000 people die each year in the United States as the result of a medication error. However, it’s impossible to say for sure what percentage of those errors involve name confusion, Dr. Gaunt said.

Not all the mistakes are reported. Some that are reported are dramatic and deadly. In 2022, a Tennessee nurse was convicted of gross neglect and negligent homicide. She was sentenced to 3 years’ probation after she mistakenly gave vercuronium, an anesthetic agent, instead of the sedative Versed to a patient, and the woman died.
 

Updated list: A closer look

Many of the new drug pairs that are listed in the update are cephalosporins, said Dr. Kliethermes, who reviewed the new list for this news organization. In all, 20 of the latest 82 additions are cephalosporins. These include drugs such as cefazolin, which can be confused with cefotetan, and vice versa. These drugs have been around since the 1980s, she said, but “they needed to be on there.” Even in the 1980s, it was becoming difficult to differentiate them, and there were fewer drugs in that class then, she said.

Influenza vaccines made the new list, too. Fluzone High-Dose Quadrivalent can be confused with fluzone quadrivalent. Other new additions: hydrochlorothiazide and hydroxychloroquine, Lasik and Wakix, Pitressin and Pitocin, Remeron and Rozerem.
 

Beyond the list

While it’s not possible to pinpoint how big a problem name confusion is in causing medication mistakes, “it is certainly still an issue,” Dr. Gaunt said. A variety of practices can reduce that risk substantially, Dr. Gaunt and Dr. Kliethermes agreed.

Tall-man lettering. Both the FDA and the ISMP recommend the use of so-called tall-man lettering (TML), which involves the use of uppercase letters, sometimes in boldface, to distinguish similar names on product labels and elsewhere. Examples include vinBLAStine and vinCRIStine.

Electronic prescribing. “It eliminates the risk of handwriting confusion,” Dr. Gaunt said. However, electronic prescribing can have a downside, Dr. Kliethermes said. When ordering medication, a person may type in a few letters and may then be presented with a prompt that lists several drug names, and it can be easy to click the wrong one. For that reason, ISMP and other experts recommend typing at least five letters when searching for a medication in an electronic system.

Use both brand and generic names on labels and prescriptions.

Write the indication. That can serve as a double check. If a prescription for Ambien says “For sleep,” there’s probably less risk of filling a prescription for ambrisentan, the vasodilator.

Smart formulary additions. When hospitals add medications to their formularies, “part of that formulary assessment should include looking at the potential risk for errors,” Dr. Gaunt said. This involves keeping an eye out for confusing names and similar packaging. “Do that analysis up front and put in strategies to minimize that. Maybe you look for a different drug [for the same use] that has a different name.” Or choose a different manufacturer, so the medication would at least have a different container.

Use bar code scanning. Suppose a pharmacist goes to the shelf and pulls the wrong drug. “Bar code scanning provides the opportunity to catch the error,” Dr. Gaunt said. Many community pharmacies now have bar code scanning. ISMP just issued best practices for community pharmacies, Dr. Gaunt said, and these include the use of bar code scanning and other measures.

Educate consumers. Health care providers can educate consumers on how to minimize the risk of getting the wrong drug, Dr. Gaunt said. When patients are picking up a prescription, suggest they look at the container label; if it looks different from previous prescriptions of the same medicine, ask the pharmacist for an explanation. Some patients just pass it off, Dr. Gaunt said, figuring the pharmacist or health plan switched manufacturers of their medication.

Access the list. The entire list is on the ISMP site and is accessible after free registration.
 

Goal: Preventing confusion

The FDA has provided guidance for industry on naming drugs not yet approved so that the proposed names are not too similar in sound or appearance to those already on the market. Included in the lengthy document are checklists, such as, “Across a range of dialects, are the names consistently pronounced differently?” and “Are the lengths of the names dissimilar when scripted?” (Lengths are considered different if they differ by two or more letters.)

The FDA also offers the phonetic and orthographic computer analysis (POCA) program, a software tool that employs an advanced algorithm to evaluate similarities between two drug names. The data sources are updated regularly as new drugs are approved.
 

Liability update

The problem may be decreasing. In a 2020 report, researchers used pharmacists’ professional liability claim data from the Healthcare Providers Service Organization. They compared 2018 data on claims with 2013 data. The percentage of claims associated with wrong drug dispensing errors declined from 43.8% in 2013 to 36.8% in 2018. Wrong dose claims also declined, from 31.5% to 15.3%.

These researchers concluded that technology and automation have contributed to the prevention of medication errors caused by the use of the wrong drug and the wrong dose, but mistakes continue, owing to system and human errors.

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

As with porridge, so with blood pressure: Just right makes all the difference.

Ill-fitting blood pressure measurement cuffs produce erroneous readings that impair hypertension treatment, according to research published in JAMA Internal Medicine.

People whose mid-upper arm circumference exceeds 32 cm require larger cuffs than the standard size, but in many cases the regular-sized cuff is used on everyone. As a result, patients with larger arms may be falsely diagnosed with high blood pressure because of a too-small cuff, leading to overprescribing of medications that could make their health worse, according to the researchers.  

“A person whose blood pressure is 120/80, which is normal – if they’re using the wrong cuff, they could get a measurement that says 140/90, let’s say,” said study author Tammy M. Brady, MD, PhD, vice chair for clinical research in the department of pediatrics at Johns Hopkins University, Baltimore. “They might think they not only have hypertension, but stage 2 hypertension. Providers might give one or even two medicines to lower this, which could lead to hypotension,” Dr. Brady said.

Conversely, someone with smaller arms whose cuff is too big may present with an artificially low blood pressure. The implications of using ill-fitting cuffs are well known. Dr. Brady, among others, has studied the topic extensively. Even so, she said the measurement errors in the latest study were larger than expected.
 

The Goldilocks test

People with an arm circumference of 20-25 cm should use a smaller cuff than the regular size, Dr. Brady and colleagues reported. Circumferences of 25.1-32 cm require a regular-sized cuff; large cuffs are for circumferences of 32.1-40 cm; and extra-large cuffs should be used at 40.1-55 cm.

The study included 195 residents of Baltimore (128 women, 67 men; 132 Black, 58 White, 5 Hispanic) with an average age of 54 years. The researchers measured every participant’s blood pressure using an automated device on four occasions, taking three measurements each time.

The first three sets of measurements used, respectively, an appropriate cuff size for each person’s arm circumference; a cuff that was too big; and a cuff that was too small. This study design ensured that a regular-sized cuff would be used during one of the three measurements – sometimes that cuff was too small, sometimes it was appropriate, and other times it was too big.

The final set of three measurements used the appropriate cuff size for a person’s arm every time. Dr. Brady and colleagues then compared people’s blood pressure measurements when using the right-sized cuff to measurements with a regular-sized cuff that was not suited for them.

They found that using a cuff that was too large for the patient’s arm (i.e., using a regular cuff when a small cuff was the right choice) led to understating systolic blood pressure by –3.6 mm Hg (95% confidence interval [CI], –5.6 to –1.7). A cuff that was one size too small – using regular instead of a large – overestimated systolic blood pressure by 4.8 (3.0-6.6) mm Hg. And a cuff that was two sizes too small – someone who should have received an extra-large cuff but received the regular size – overestimated systolic blood pressure by 19.5 (16.1-22.9) mm Hg. All differences were statistically significant, the researchers reported.

“To our knowledge, this is the first randomized cross-over trial to examine the effect of miscuffing on automated blood pressure readings,” Mathias Lalika, MD, MPH, of the Mayo Clinic in Rochester, Minn.; Stephen P. Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center in Boston; and LaPrincess C. Brewer, MD, MPH, of the Mayo Clinic, wrote in an editorial accompanying the journal article.

“Interestingly, the degree of underestimation or overestimation increased as the appropriate cuff size progressed from the regular to extra-large BP cuff. More importantly, the effect of miscuffing did not vary with BP or obesity status,” they wrote.

“This was more of a pragmatic trial to see real world, all comers,” Dr. Brady said, when regular-sized cuffs are used whether or not that made sense.

“This study reaffirms findings of previous studies and highlights a major source of error in blood pressure measurement,” Raj Padwal, MD, director of the University of Alberta Hypertension Clinic, Edmonton, Alta., said in an interview. Dr. Padwal, who was not involved in the study, said the findings highlight the importance of ensuring that technicians who typically measure blood pressure understand the value of using the right-sized cuff.

Dr. Brady noted that measuring arm circumference takes about 15 seconds. He advised health organizations and clinics to carry multiple cuffs sizes to avoid a scramble to find a right-sized cuff. In the editorial, Dr. Lalika, Dr. Juraschek, and Dr. Brewer call for particular attention to providing the right-sized cuffs to facilities that work with underserved populations, such as federally qualified health centers.

Dr. Padwal added that even a perfectly measured blood pressure test at a clinic indicates pressure at a moment in time. Ten minutes later the story could be different. For this reason, he and other clinicians recommend frequent home blood pressure measurements rather than relying solely on the sparse number of readings collected in the clinic setting.

“A properly educated patient can give many readings that are separated in space and time and, when averaged, can give a much better picture of overall blood pressure and future risk,” Dr. Padwal said. 

Dr. Brady agreed with the value of home readings but said home-based readings also can be erroneous if the patient uses a cuff that is the wrong size. She cochairs a committee for the American Medical Association that recommends validated home blood pressure measurement devices on a periodically updated website called Validate BP. The details for each device listing show the cuff sizes available per device. Many devices provide only the standard cuff, Dr. Brady noted, but some offer multiple cuff sizes.

“One of the things that would be great if it came out of this paper is if patients were empowered to ask physicians to measure their arm” and then use that information to select the appropriate cuff for their home device, she said.

Dr. Brady and Dr. Padwal reported no relevant financial relationships. This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill & Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.

A version of this article appeared on Medscape.com.

As with porridge, so with blood pressure: Just right makes all the difference.

Ill-fitting blood pressure measurement cuffs produce erroneous readings that impair hypertension treatment, according to research published in JAMA Internal Medicine.

People whose mid-upper arm circumference exceeds 32 cm require larger cuffs than the standard size, but in many cases the regular-sized cuff is used on everyone. As a result, patients with larger arms may be falsely diagnosed with high blood pressure because of a too-small cuff, leading to overprescribing of medications that could make their health worse, according to the researchers.  

“A person whose blood pressure is 120/80, which is normal – if they’re using the wrong cuff, they could get a measurement that says 140/90, let’s say,” said study author Tammy M. Brady, MD, PhD, vice chair for clinical research in the department of pediatrics at Johns Hopkins University, Baltimore. “They might think they not only have hypertension, but stage 2 hypertension. Providers might give one or even two medicines to lower this, which could lead to hypotension,” Dr. Brady said.

Conversely, someone with smaller arms whose cuff is too big may present with an artificially low blood pressure. The implications of using ill-fitting cuffs are well known. Dr. Brady, among others, has studied the topic extensively. Even so, she said the measurement errors in the latest study were larger than expected.
 

The Goldilocks test

People with an arm circumference of 20-25 cm should use a smaller cuff than the regular size, Dr. Brady and colleagues reported. Circumferences of 25.1-32 cm require a regular-sized cuff; large cuffs are for circumferences of 32.1-40 cm; and extra-large cuffs should be used at 40.1-55 cm.

The study included 195 residents of Baltimore (128 women, 67 men; 132 Black, 58 White, 5 Hispanic) with an average age of 54 years. The researchers measured every participant’s blood pressure using an automated device on four occasions, taking three measurements each time.

The first three sets of measurements used, respectively, an appropriate cuff size for each person’s arm circumference; a cuff that was too big; and a cuff that was too small. This study design ensured that a regular-sized cuff would be used during one of the three measurements – sometimes that cuff was too small, sometimes it was appropriate, and other times it was too big.

The final set of three measurements used the appropriate cuff size for a person’s arm every time. Dr. Brady and colleagues then compared people’s blood pressure measurements when using the right-sized cuff to measurements with a regular-sized cuff that was not suited for them.

They found that using a cuff that was too large for the patient’s arm (i.e., using a regular cuff when a small cuff was the right choice) led to understating systolic blood pressure by –3.6 mm Hg (95% confidence interval [CI], –5.6 to –1.7). A cuff that was one size too small – using regular instead of a large – overestimated systolic blood pressure by 4.8 (3.0-6.6) mm Hg. And a cuff that was two sizes too small – someone who should have received an extra-large cuff but received the regular size – overestimated systolic blood pressure by 19.5 (16.1-22.9) mm Hg. All differences were statistically significant, the researchers reported.

“To our knowledge, this is the first randomized cross-over trial to examine the effect of miscuffing on automated blood pressure readings,” Mathias Lalika, MD, MPH, of the Mayo Clinic in Rochester, Minn.; Stephen P. Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center in Boston; and LaPrincess C. Brewer, MD, MPH, of the Mayo Clinic, wrote in an editorial accompanying the journal article.

“Interestingly, the degree of underestimation or overestimation increased as the appropriate cuff size progressed from the regular to extra-large BP cuff. More importantly, the effect of miscuffing did not vary with BP or obesity status,” they wrote.

“This was more of a pragmatic trial to see real world, all comers,” Dr. Brady said, when regular-sized cuffs are used whether or not that made sense.

“This study reaffirms findings of previous studies and highlights a major source of error in blood pressure measurement,” Raj Padwal, MD, director of the University of Alberta Hypertension Clinic, Edmonton, Alta., said in an interview. Dr. Padwal, who was not involved in the study, said the findings highlight the importance of ensuring that technicians who typically measure blood pressure understand the value of using the right-sized cuff.

Dr. Brady noted that measuring arm circumference takes about 15 seconds. He advised health organizations and clinics to carry multiple cuffs sizes to avoid a scramble to find a right-sized cuff. In the editorial, Dr. Lalika, Dr. Juraschek, and Dr. Brewer call for particular attention to providing the right-sized cuffs to facilities that work with underserved populations, such as federally qualified health centers.

Dr. Padwal added that even a perfectly measured blood pressure test at a clinic indicates pressure at a moment in time. Ten minutes later the story could be different. For this reason, he and other clinicians recommend frequent home blood pressure measurements rather than relying solely on the sparse number of readings collected in the clinic setting.

“A properly educated patient can give many readings that are separated in space and time and, when averaged, can give a much better picture of overall blood pressure and future risk,” Dr. Padwal said. 

Dr. Brady agreed with the value of home readings but said home-based readings also can be erroneous if the patient uses a cuff that is the wrong size. She cochairs a committee for the American Medical Association that recommends validated home blood pressure measurement devices on a periodically updated website called Validate BP. The details for each device listing show the cuff sizes available per device. Many devices provide only the standard cuff, Dr. Brady noted, but some offer multiple cuff sizes.

“One of the things that would be great if it came out of this paper is if patients were empowered to ask physicians to measure their arm” and then use that information to select the appropriate cuff for their home device, she said.

Dr. Brady and Dr. Padwal reported no relevant financial relationships. This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill & Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.

A version of this article appeared on Medscape.com.

As with porridge, so with blood pressure: Just right makes all the difference.

Ill-fitting blood pressure measurement cuffs produce erroneous readings that impair hypertension treatment, according to research published in JAMA Internal Medicine.

People whose mid-upper arm circumference exceeds 32 cm require larger cuffs than the standard size, but in many cases the regular-sized cuff is used on everyone. As a result, patients with larger arms may be falsely diagnosed with high blood pressure because of a too-small cuff, leading to overprescribing of medications that could make their health worse, according to the researchers.  

“A person whose blood pressure is 120/80, which is normal – if they’re using the wrong cuff, they could get a measurement that says 140/90, let’s say,” said study author Tammy M. Brady, MD, PhD, vice chair for clinical research in the department of pediatrics at Johns Hopkins University, Baltimore. “They might think they not only have hypertension, but stage 2 hypertension. Providers might give one or even two medicines to lower this, which could lead to hypotension,” Dr. Brady said.

Conversely, someone with smaller arms whose cuff is too big may present with an artificially low blood pressure. The implications of using ill-fitting cuffs are well known. Dr. Brady, among others, has studied the topic extensively. Even so, she said the measurement errors in the latest study were larger than expected.
 

The Goldilocks test

People with an arm circumference of 20-25 cm should use a smaller cuff than the regular size, Dr. Brady and colleagues reported. Circumferences of 25.1-32 cm require a regular-sized cuff; large cuffs are for circumferences of 32.1-40 cm; and extra-large cuffs should be used at 40.1-55 cm.

The study included 195 residents of Baltimore (128 women, 67 men; 132 Black, 58 White, 5 Hispanic) with an average age of 54 years. The researchers measured every participant’s blood pressure using an automated device on four occasions, taking three measurements each time.

The first three sets of measurements used, respectively, an appropriate cuff size for each person’s arm circumference; a cuff that was too big; and a cuff that was too small. This study design ensured that a regular-sized cuff would be used during one of the three measurements – sometimes that cuff was too small, sometimes it was appropriate, and other times it was too big.

The final set of three measurements used the appropriate cuff size for a person’s arm every time. Dr. Brady and colleagues then compared people’s blood pressure measurements when using the right-sized cuff to measurements with a regular-sized cuff that was not suited for them.

They found that using a cuff that was too large for the patient’s arm (i.e., using a regular cuff when a small cuff was the right choice) led to understating systolic blood pressure by –3.6 mm Hg (95% confidence interval [CI], –5.6 to –1.7). A cuff that was one size too small – using regular instead of a large – overestimated systolic blood pressure by 4.8 (3.0-6.6) mm Hg. And a cuff that was two sizes too small – someone who should have received an extra-large cuff but received the regular size – overestimated systolic blood pressure by 19.5 (16.1-22.9) mm Hg. All differences were statistically significant, the researchers reported.

“To our knowledge, this is the first randomized cross-over trial to examine the effect of miscuffing on automated blood pressure readings,” Mathias Lalika, MD, MPH, of the Mayo Clinic in Rochester, Minn.; Stephen P. Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center in Boston; and LaPrincess C. Brewer, MD, MPH, of the Mayo Clinic, wrote in an editorial accompanying the journal article.

“Interestingly, the degree of underestimation or overestimation increased as the appropriate cuff size progressed from the regular to extra-large BP cuff. More importantly, the effect of miscuffing did not vary with BP or obesity status,” they wrote.

“This was more of a pragmatic trial to see real world, all comers,” Dr. Brady said, when regular-sized cuffs are used whether or not that made sense.

“This study reaffirms findings of previous studies and highlights a major source of error in blood pressure measurement,” Raj Padwal, MD, director of the University of Alberta Hypertension Clinic, Edmonton, Alta., said in an interview. Dr. Padwal, who was not involved in the study, said the findings highlight the importance of ensuring that technicians who typically measure blood pressure understand the value of using the right-sized cuff.

Dr. Brady noted that measuring arm circumference takes about 15 seconds. He advised health organizations and clinics to carry multiple cuffs sizes to avoid a scramble to find a right-sized cuff. In the editorial, Dr. Lalika, Dr. Juraschek, and Dr. Brewer call for particular attention to providing the right-sized cuffs to facilities that work with underserved populations, such as federally qualified health centers.

Dr. Padwal added that even a perfectly measured blood pressure test at a clinic indicates pressure at a moment in time. Ten minutes later the story could be different. For this reason, he and other clinicians recommend frequent home blood pressure measurements rather than relying solely on the sparse number of readings collected in the clinic setting.

“A properly educated patient can give many readings that are separated in space and time and, when averaged, can give a much better picture of overall blood pressure and future risk,” Dr. Padwal said. 

Dr. Brady agreed with the value of home readings but said home-based readings also can be erroneous if the patient uses a cuff that is the wrong size. She cochairs a committee for the American Medical Association that recommends validated home blood pressure measurement devices on a periodically updated website called Validate BP. The details for each device listing show the cuff sizes available per device. Many devices provide only the standard cuff, Dr. Brady noted, but some offer multiple cuff sizes.

“One of the things that would be great if it came out of this paper is if patients were empowered to ask physicians to measure their arm” and then use that information to select the appropriate cuff for their home device, she said.

Dr. Brady and Dr. Padwal reported no relevant financial relationships. This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill & Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.

A version of this article appeared on Medscape.com.