Since the start of the pandemic, supply-chain problems have permeated just about every industry sector. While most of the media attention has focused on toilet paper and retail shipment delays, a darker, more sinister supply chain disruption has been unfolding, one that entails a sophisticated criminal enterprise that has been operating at scale to distribute and profit from counterfeit HIV drugs.

Recently, news has emerged – most notably in the Wall Street Journal – with reports of a Justice Department investigation into what appears to be a national drug trafficking network comprising more than 70 distributors and marketers.

The details read like a best-selling crime novel.

Since last year, authorities have seized 85,247 bottles of counterfeit HIV drugs, both Biktarvy (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets) and Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets). Law enforcement has conducted raids at 17 locations in eight states. Doctored supply chain papers have provided cover for the fake medicines and the individuals behind them.

But unlike the inconvenience of sparse toilet paper, this crime poses life-threatening risks to millions of patients with HIV who rely on Biktarvy to suppress the virus or Descovy to prevent infection from it. Even worse, some patients have been exposed to over-the-counter painkillers or the antipsychotic drug quetiapine fumarate masquerading as HIV drugs in legitimate but repurposed bottles.

Gilead Sciences (Foster City, Calif.), which manufactures both Biktarvy and Descovy, declined to comment when contacted, instead referring this news organization to previous press statements.
 

Falsified HIV medications, illicit purchases over 2 Years

On Aug. 5, 2021, Gilead first warned the public that it had become aware of tampered and counterfeit Biktarvy and Descovy tablets. In coordination with the Food and Drug Administration, it alerted pharmacies to “investigate the potential for counterfeit or tampered Gilead medication sold by [unauthorized] distributors that may be within their recent supply.”

On Jan. 19, 2022, Gilead issued a second statement outlining ongoing actions in coordination with U.S. marshals and local law enforcement to remove these illegal medications from circulation and prevent further distribution.

The timing of the most recent announcement was not accidental. The day before, a federal judge serving the U.S. District Court for the Eastern District of New York unsealed documents detailing the company’s lawsuit against dozens of individuals and entities who they alleged had engaged in a highly coordinated effort to defraud pharmacies and consumers. The suit followed two prior Gilead filings that ultimately resulted in court-issued ex parte seizure orders (orders that allow a court to seize property without the property owner’s consent) and the recovery of more than 1,000 bottles containing questionable Gilead medications.

The lawsuit centered on Cambridge, Mass.–based wholesale pharmaceutical distributor Safe Chain Solutions and its two cofounders. The document is peppered with terms such as “shifting series of fly-by-night corporate entities,” “gray market” distributors, a “dedicated sales force,” and “shell entities,” along with accusations that the defendants were believed to have made purchases of gold bullion, jewelry, and other luxury items for conversion into cash.

In a curious twist of fate, this sinister effort appeared to have been first revealed not by a pharmacist but by a patient who had returned a bottle of Biktarvy with “foreign medication inside” to the California pharmacy that dispensed it.

“Specifically with HIV medications, there’s no point in which the pharmacy is actually opening the bottle, breaking the seal, and counting out pills to put into a smaller prescription bottle,” Emily Heil, PharmD, BCIDP, AAHIVP, associate professor of infectious diseases in the department of pharmacy practice and science at the University of Maryland School of Pharmacy, Baltimore, told this news organization.

“But that’s also why pharmacies work with these centralized groups of distributors that maintain a chain of command and fidelity with drug manufacturers so that we don’t run into these situations,” she said.

This is the link in the chain where that tightly coordinated and highly regulated process was broken.

Although Gilead and Safe Chain Solutions were informed of the incident as early as August 2020, the distributor repeatedly refused to identify the supplier and the pedigree (the record demonstrating the chain of all sales or transfers of a specific drug, going back to the manufacturer, as required by the FDA’s Drug Supply Chain Security Act in 2013).

Later that year, Janssen Pharmaceutical Companies of Johnson & Johnson issued a media statement saying that they had been alerted to the distribution of counterfeit Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) to three pharmacies in the United States.

A spokesperson for the FDA declined to comment on the ongoing investigation when contacted by this news organization and instead wrote in an email that the agency “will continue to use all available tools to ensure consumers and patients have access to a safe and effective medical product supply.”
 

Old dog, new tricks

This is not the first time that HIV drugs have been targeted for criminal benefit. An analysis published in September 2014 in JAMA highlighted a federal investigation that year into a $32 million dollar scheme to defraud Medicare’s Part D program for HIV drugs and divert them for resale on the black market.

What’s more, prior research and news reports highlight the attractiveness of HIV drug diversion both for the buyer and the seller – not only because of the cost of the drugs themselves but also because of institutional or systemic deficiencies that exclude certain individuals from obtaining treatment through federal initiatives such as the Ryan White/AIDS Drug Assistance program.

In its most recent statement, Gilead reinforced that this practice remains alive and well.

On the buyer side, the company stated, many of the counterfeits originated from suppliers who purchased Gilead HIV medication from individuals after it was first dispensed to them. Unfortunately, the exploitation of individuals with low incomes who experience homelessness or substance use/abuse echoes a pattern whereby HIV patients sell medications to cover personal needs or are forced to buy them on the black market to keep up with their treatment regimens.

On the supply side, Gilead explained that individuals’ medications “are unlawfully resold ... on the secondary market by way of counterfeit supply chain documentation, concealing and fraudulently misrepresenting its origin. All of these counterfeits were sold as though they were legitimate Gilead products.”

But counterfeit pedigrees make it impossible to verify where the products came from, how they have been handled and stored, and what pills are in the bottles – all of which can have dire consequences for patients who ingest them.

The ramifications can be devastating.

“With HIV meds specifically, the worst case scenario would be if the medication is not actually the medication they’re supposed to be on,” said Dr. Heil, reinforcing that the increased safety net provided with viral suppression and against transmission is lost.

Dr. Heil pointed to another significant risk: resistance.

“In a situation like this, where maybe it’s not the full strength of the medication, maybe it’s expired and lost potency or was not stored correctly or is not even the accurate medication, changing those drug level exposures potentially puts the patient at risk for developing resistance to their regimen without them knowing.”

Yet another risk was posed by the replacement of HIV drugs with other medications, such as quetiapine, which increased the risk for life-threatening and irreversible side effects. The lawsuit included a story of a patient who unknowingly took quetiapine after receiving a counterfeit bottle of Biktarvy and could not speak or walk afterward.

Where this tale will ultimately end is unclear. There’s no telling what other activities or bad actors the Justice Department investigation will uncover as it works to unravel the counterfeit network’s activities and deal with its aftermath.

Regardless, clinicians are encouraged to inform HIV patients about the risks associated with counterfeit medications, how to determine whether the drugs they’ve been dispensed are authentic, and to report any product they believe to be counterfeit or to have been tampered with to their doctors, pharmacies, and to Gilead or other drug manufacturers.

“It’s okay to ask questions of your pharmacy about where they get their medications from,” noted Dr. Heil. “If patients have access to an independent pharmacy, it’s a great way for them to have a relationship with their pharmacist.

“We went into this profession to be able to have those conversations with patients,” Dr. Heil said.

The FDA recommends that patients receiving these medications who believe that their drugs may be counterfeit or who experience any adverse effects report the event to FDA’s MedWatch Safety Information and Adverse Event Reporting Program (1-800-FDA-1088 or www.fda.gov/medwatch).

Dr. Heil reported having no relevant financial relationships.

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

Since the start of the pandemic, supply-chain problems have permeated just about every industry sector. While most of the media attention has focused on toilet paper and retail shipment delays, a darker, more sinister supply chain disruption has been unfolding, one that entails a sophisticated criminal enterprise that has been operating at scale to distribute and profit from counterfeit HIV drugs.

Recently, news has emerged – most notably in the Wall Street Journal – with reports of a Justice Department investigation into what appears to be a national drug trafficking network comprising more than 70 distributors and marketers.

The details read like a best-selling crime novel.

Since last year, authorities have seized 85,247 bottles of counterfeit HIV drugs, both Biktarvy (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets) and Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets). Law enforcement has conducted raids at 17 locations in eight states. Doctored supply chain papers have provided cover for the fake medicines and the individuals behind them.

But unlike the inconvenience of sparse toilet paper, this crime poses life-threatening risks to millions of patients with HIV who rely on Biktarvy to suppress the virus or Descovy to prevent infection from it. Even worse, some patients have been exposed to over-the-counter painkillers or the antipsychotic drug quetiapine fumarate masquerading as HIV drugs in legitimate but repurposed bottles.

Gilead Sciences (Foster City, Calif.), which manufactures both Biktarvy and Descovy, declined to comment when contacted, instead referring this news organization to previous press statements.
 

Falsified HIV medications, illicit purchases over 2 Years

On Aug. 5, 2021, Gilead first warned the public that it had become aware of tampered and counterfeit Biktarvy and Descovy tablets. In coordination with the Food and Drug Administration, it alerted pharmacies to “investigate the potential for counterfeit or tampered Gilead medication sold by [unauthorized] distributors that may be within their recent supply.”

On Jan. 19, 2022, Gilead issued a second statement outlining ongoing actions in coordination with U.S. marshals and local law enforcement to remove these illegal medications from circulation and prevent further distribution.

The timing of the most recent announcement was not accidental. The day before, a federal judge serving the U.S. District Court for the Eastern District of New York unsealed documents detailing the company’s lawsuit against dozens of individuals and entities who they alleged had engaged in a highly coordinated effort to defraud pharmacies and consumers. The suit followed two prior Gilead filings that ultimately resulted in court-issued ex parte seizure orders (orders that allow a court to seize property without the property owner’s consent) and the recovery of more than 1,000 bottles containing questionable Gilead medications.

The lawsuit centered on Cambridge, Mass.–based wholesale pharmaceutical distributor Safe Chain Solutions and its two cofounders. The document is peppered with terms such as “shifting series of fly-by-night corporate entities,” “gray market” distributors, a “dedicated sales force,” and “shell entities,” along with accusations that the defendants were believed to have made purchases of gold bullion, jewelry, and other luxury items for conversion into cash.

In a curious twist of fate, this sinister effort appeared to have been first revealed not by a pharmacist but by a patient who had returned a bottle of Biktarvy with “foreign medication inside” to the California pharmacy that dispensed it.

“Specifically with HIV medications, there’s no point in which the pharmacy is actually opening the bottle, breaking the seal, and counting out pills to put into a smaller prescription bottle,” Emily Heil, PharmD, BCIDP, AAHIVP, associate professor of infectious diseases in the department of pharmacy practice and science at the University of Maryland School of Pharmacy, Baltimore, told this news organization.

“But that’s also why pharmacies work with these centralized groups of distributors that maintain a chain of command and fidelity with drug manufacturers so that we don’t run into these situations,” she said.

This is the link in the chain where that tightly coordinated and highly regulated process was broken.

Although Gilead and Safe Chain Solutions were informed of the incident as early as August 2020, the distributor repeatedly refused to identify the supplier and the pedigree (the record demonstrating the chain of all sales or transfers of a specific drug, going back to the manufacturer, as required by the FDA’s Drug Supply Chain Security Act in 2013).

Later that year, Janssen Pharmaceutical Companies of Johnson & Johnson issued a media statement saying that they had been alerted to the distribution of counterfeit Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) to three pharmacies in the United States.

A spokesperson for the FDA declined to comment on the ongoing investigation when contacted by this news organization and instead wrote in an email that the agency “will continue to use all available tools to ensure consumers and patients have access to a safe and effective medical product supply.”
 

Old dog, new tricks

This is not the first time that HIV drugs have been targeted for criminal benefit. An analysis published in September 2014 in JAMA highlighted a federal investigation that year into a $32 million dollar scheme to defraud Medicare’s Part D program for HIV drugs and divert them for resale on the black market.

What’s more, prior research and news reports highlight the attractiveness of HIV drug diversion both for the buyer and the seller – not only because of the cost of the drugs themselves but also because of institutional or systemic deficiencies that exclude certain individuals from obtaining treatment through federal initiatives such as the Ryan White/AIDS Drug Assistance program.

In its most recent statement, Gilead reinforced that this practice remains alive and well.

On the buyer side, the company stated, many of the counterfeits originated from suppliers who purchased Gilead HIV medication from individuals after it was first dispensed to them. Unfortunately, the exploitation of individuals with low incomes who experience homelessness or substance use/abuse echoes a pattern whereby HIV patients sell medications to cover personal needs or are forced to buy them on the black market to keep up with their treatment regimens.

On the supply side, Gilead explained that individuals’ medications “are unlawfully resold ... on the secondary market by way of counterfeit supply chain documentation, concealing and fraudulently misrepresenting its origin. All of these counterfeits were sold as though they were legitimate Gilead products.”

But counterfeit pedigrees make it impossible to verify where the products came from, how they have been handled and stored, and what pills are in the bottles – all of which can have dire consequences for patients who ingest them.

The ramifications can be devastating.

“With HIV meds specifically, the worst case scenario would be if the medication is not actually the medication they’re supposed to be on,” said Dr. Heil, reinforcing that the increased safety net provided with viral suppression and against transmission is lost.

Dr. Heil pointed to another significant risk: resistance.

“In a situation like this, where maybe it’s not the full strength of the medication, maybe it’s expired and lost potency or was not stored correctly or is not even the accurate medication, changing those drug level exposures potentially puts the patient at risk for developing resistance to their regimen without them knowing.”

Yet another risk was posed by the replacement of HIV drugs with other medications, such as quetiapine, which increased the risk for life-threatening and irreversible side effects. The lawsuit included a story of a patient who unknowingly took quetiapine after receiving a counterfeit bottle of Biktarvy and could not speak or walk afterward.

Where this tale will ultimately end is unclear. There’s no telling what other activities or bad actors the Justice Department investigation will uncover as it works to unravel the counterfeit network’s activities and deal with its aftermath.

Regardless, clinicians are encouraged to inform HIV patients about the risks associated with counterfeit medications, how to determine whether the drugs they’ve been dispensed are authentic, and to report any product they believe to be counterfeit or to have been tampered with to their doctors, pharmacies, and to Gilead or other drug manufacturers.

“It’s okay to ask questions of your pharmacy about where they get their medications from,” noted Dr. Heil. “If patients have access to an independent pharmacy, it’s a great way for them to have a relationship with their pharmacist.

“We went into this profession to be able to have those conversations with patients,” Dr. Heil said.

The FDA recommends that patients receiving these medications who believe that their drugs may be counterfeit or who experience any adverse effects report the event to FDA’s MedWatch Safety Information and Adverse Event Reporting Program (1-800-FDA-1088 or www.fda.gov/medwatch).

Dr. Heil reported having no relevant financial relationships.

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

Since the start of the pandemic, supply-chain problems have permeated just about every industry sector. While most of the media attention has focused on toilet paper and retail shipment delays, a darker, more sinister supply chain disruption has been unfolding, one that entails a sophisticated criminal enterprise that has been operating at scale to distribute and profit from counterfeit HIV drugs.

Recently, news has emerged – most notably in the Wall Street Journal – with reports of a Justice Department investigation into what appears to be a national drug trafficking network comprising more than 70 distributors and marketers.

The details read like a best-selling crime novel.

Since last year, authorities have seized 85,247 bottles of counterfeit HIV drugs, both Biktarvy (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets) and Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets). Law enforcement has conducted raids at 17 locations in eight states. Doctored supply chain papers have provided cover for the fake medicines and the individuals behind them.

But unlike the inconvenience of sparse toilet paper, this crime poses life-threatening risks to millions of patients with HIV who rely on Biktarvy to suppress the virus or Descovy to prevent infection from it. Even worse, some patients have been exposed to over-the-counter painkillers or the antipsychotic drug quetiapine fumarate masquerading as HIV drugs in legitimate but repurposed bottles.

Gilead Sciences (Foster City, Calif.), which manufactures both Biktarvy and Descovy, declined to comment when contacted, instead referring this news organization to previous press statements.
 

Falsified HIV medications, illicit purchases over 2 Years

On Aug. 5, 2021, Gilead first warned the public that it had become aware of tampered and counterfeit Biktarvy and Descovy tablets. In coordination with the Food and Drug Administration, it alerted pharmacies to “investigate the potential for counterfeit or tampered Gilead medication sold by [unauthorized] distributors that may be within their recent supply.”

On Jan. 19, 2022, Gilead issued a second statement outlining ongoing actions in coordination with U.S. marshals and local law enforcement to remove these illegal medications from circulation and prevent further distribution.

The timing of the most recent announcement was not accidental. The day before, a federal judge serving the U.S. District Court for the Eastern District of New York unsealed documents detailing the company’s lawsuit against dozens of individuals and entities who they alleged had engaged in a highly coordinated effort to defraud pharmacies and consumers. The suit followed two prior Gilead filings that ultimately resulted in court-issued ex parte seizure orders (orders that allow a court to seize property without the property owner’s consent) and the recovery of more than 1,000 bottles containing questionable Gilead medications.

The lawsuit centered on Cambridge, Mass.–based wholesale pharmaceutical distributor Safe Chain Solutions and its two cofounders. The document is peppered with terms such as “shifting series of fly-by-night corporate entities,” “gray market” distributors, a “dedicated sales force,” and “shell entities,” along with accusations that the defendants were believed to have made purchases of gold bullion, jewelry, and other luxury items for conversion into cash.

In a curious twist of fate, this sinister effort appeared to have been first revealed not by a pharmacist but by a patient who had returned a bottle of Biktarvy with “foreign medication inside” to the California pharmacy that dispensed it.

“Specifically with HIV medications, there’s no point in which the pharmacy is actually opening the bottle, breaking the seal, and counting out pills to put into a smaller prescription bottle,” Emily Heil, PharmD, BCIDP, AAHIVP, associate professor of infectious diseases in the department of pharmacy practice and science at the University of Maryland School of Pharmacy, Baltimore, told this news organization.

“But that’s also why pharmacies work with these centralized groups of distributors that maintain a chain of command and fidelity with drug manufacturers so that we don’t run into these situations,” she said.

This is the link in the chain where that tightly coordinated and highly regulated process was broken.

Although Gilead and Safe Chain Solutions were informed of the incident as early as August 2020, the distributor repeatedly refused to identify the supplier and the pedigree (the record demonstrating the chain of all sales or transfers of a specific drug, going back to the manufacturer, as required by the FDA’s Drug Supply Chain Security Act in 2013).

Later that year, Janssen Pharmaceutical Companies of Johnson & Johnson issued a media statement saying that they had been alerted to the distribution of counterfeit Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) to three pharmacies in the United States.

A spokesperson for the FDA declined to comment on the ongoing investigation when contacted by this news organization and instead wrote in an email that the agency “will continue to use all available tools to ensure consumers and patients have access to a safe and effective medical product supply.”
 

Old dog, new tricks

This is not the first time that HIV drugs have been targeted for criminal benefit. An analysis published in September 2014 in JAMA highlighted a federal investigation that year into a $32 million dollar scheme to defraud Medicare’s Part D program for HIV drugs and divert them for resale on the black market.

What’s more, prior research and news reports highlight the attractiveness of HIV drug diversion both for the buyer and the seller – not only because of the cost of the drugs themselves but also because of institutional or systemic deficiencies that exclude certain individuals from obtaining treatment through federal initiatives such as the Ryan White/AIDS Drug Assistance program.

In its most recent statement, Gilead reinforced that this practice remains alive and well.

On the buyer side, the company stated, many of the counterfeits originated from suppliers who purchased Gilead HIV medication from individuals after it was first dispensed to them. Unfortunately, the exploitation of individuals with low incomes who experience homelessness or substance use/abuse echoes a pattern whereby HIV patients sell medications to cover personal needs or are forced to buy them on the black market to keep up with their treatment regimens.

On the supply side, Gilead explained that individuals’ medications “are unlawfully resold ... on the secondary market by way of counterfeit supply chain documentation, concealing and fraudulently misrepresenting its origin. All of these counterfeits were sold as though they were legitimate Gilead products.”

But counterfeit pedigrees make it impossible to verify where the products came from, how they have been handled and stored, and what pills are in the bottles – all of which can have dire consequences for patients who ingest them.

The ramifications can be devastating.

“With HIV meds specifically, the worst case scenario would be if the medication is not actually the medication they’re supposed to be on,” said Dr. Heil, reinforcing that the increased safety net provided with viral suppression and against transmission is lost.

Dr. Heil pointed to another significant risk: resistance.

“In a situation like this, where maybe it’s not the full strength of the medication, maybe it’s expired and lost potency or was not stored correctly or is not even the accurate medication, changing those drug level exposures potentially puts the patient at risk for developing resistance to their regimen without them knowing.”

Yet another risk was posed by the replacement of HIV drugs with other medications, such as quetiapine, which increased the risk for life-threatening and irreversible side effects. The lawsuit included a story of a patient who unknowingly took quetiapine after receiving a counterfeit bottle of Biktarvy and could not speak or walk afterward.

Where this tale will ultimately end is unclear. There’s no telling what other activities or bad actors the Justice Department investigation will uncover as it works to unravel the counterfeit network’s activities and deal with its aftermath.

Regardless, clinicians are encouraged to inform HIV patients about the risks associated with counterfeit medications, how to determine whether the drugs they’ve been dispensed are authentic, and to report any product they believe to be counterfeit or to have been tampered with to their doctors, pharmacies, and to Gilead or other drug manufacturers.

“It’s okay to ask questions of your pharmacy about where they get their medications from,” noted Dr. Heil. “If patients have access to an independent pharmacy, it’s a great way for them to have a relationship with their pharmacist.

“We went into this profession to be able to have those conversations with patients,” Dr. Heil said.

The FDA recommends that patients receiving these medications who believe that their drugs may be counterfeit or who experience any adverse effects report the event to FDA’s MedWatch Safety Information and Adverse Event Reporting Program (1-800-FDA-1088 or www.fda.gov/medwatch).

Dr. Heil reported having no relevant financial relationships.

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

A popular fitness tracker company has received approval from the Food and Drug Administration for a new software algorithm to detect atrial fibrillation (AFib), Fitbit announced on April 11.

The algorithm will be the basis of an upcoming Fitbit feature called Irregular Heart Rhythm Notifications, the company said in a press release.

The approval was based on data from the Fitbit Heart Study, which was conducted entirely virtually in more than 455,000 U.S. adults. Participants who had an irregular heart rhythm detected by the software algorithm were notified and invited to meet with a telehealth doctor. They then received a 1-week ECG patch monitor to wear along with the smartwatch or fitness tracker.

Results, presented at the annual scientific sessions of the American Heart Association in November 2021, showed that the positive predictive value of the Fitbit algorithm for detecting undiagnosed AFib with a range of wearable devices was 98%. Notably, irregular heart rhythm detection occurred in 1% of participants overall and 4% of those older than 65 years.

The algorithm works by using an optical measurement method called photoplethysmography (PPG), along with heart rate input from the Fitbit’s photodetector device.

It operates only when the user is still or at rest, so overnight use is important for detection, the company noted.

The upcoming Irregular Heart Rhythm Notifications feature will complement the existing ECG app, providing two ways to detect AFib. The ECG app provides a “spot-check approach” in which the users can screen themselves, and the PPG-based feature will allow for long-term heart rhythm assessment, the statement explained.

“Undiagnosed atrial fibrillation can lead to strokes, and early detection of atrial fibrillation may allow doctors to prescribe medications that are effective at preventing strokes,” said Steven A. Lubitz, MD, MPH, a cardiologist at Harvard University and Massachusetts General Hospital, both in Boston, at the AHA meeting.

A popular fitness tracker company has received approval from the Food and Drug Administration for a new software algorithm to detect atrial fibrillation (AFib), Fitbit announced on April 11.

The algorithm will be the basis of an upcoming Fitbit feature called Irregular Heart Rhythm Notifications, the company said in a press release.

The approval was based on data from the Fitbit Heart Study, which was conducted entirely virtually in more than 455,000 U.S. adults. Participants who had an irregular heart rhythm detected by the software algorithm were notified and invited to meet with a telehealth doctor. They then received a 1-week ECG patch monitor to wear along with the smartwatch or fitness tracker.

Results, presented at the annual scientific sessions of the American Heart Association in November 2021, showed that the positive predictive value of the Fitbit algorithm for detecting undiagnosed AFib with a range of wearable devices was 98%. Notably, irregular heart rhythm detection occurred in 1% of participants overall and 4% of those older than 65 years.

The algorithm works by using an optical measurement method called photoplethysmography (PPG), along with heart rate input from the Fitbit’s photodetector device.

It operates only when the user is still or at rest, so overnight use is important for detection, the company noted.

The upcoming Irregular Heart Rhythm Notifications feature will complement the existing ECG app, providing two ways to detect AFib. The ECG app provides a “spot-check approach” in which the users can screen themselves, and the PPG-based feature will allow for long-term heart rhythm assessment, the statement explained.

“Undiagnosed atrial fibrillation can lead to strokes, and early detection of atrial fibrillation may allow doctors to prescribe medications that are effective at preventing strokes,” said Steven A. Lubitz, MD, MPH, a cardiologist at Harvard University and Massachusetts General Hospital, both in Boston, at the AHA meeting.

A popular fitness tracker company has received approval from the Food and Drug Administration for a new software algorithm to detect atrial fibrillation (AFib), Fitbit announced on April 11.

The algorithm will be the basis of an upcoming Fitbit feature called Irregular Heart Rhythm Notifications, the company said in a press release.

The approval was based on data from the Fitbit Heart Study, which was conducted entirely virtually in more than 455,000 U.S. adults. Participants who had an irregular heart rhythm detected by the software algorithm were notified and invited to meet with a telehealth doctor. They then received a 1-week ECG patch monitor to wear along with the smartwatch or fitness tracker.

Results, presented at the annual scientific sessions of the American Heart Association in November 2021, showed that the positive predictive value of the Fitbit algorithm for detecting undiagnosed AFib with a range of wearable devices was 98%. Notably, irregular heart rhythm detection occurred in 1% of participants overall and 4% of those older than 65 years.

The algorithm works by using an optical measurement method called photoplethysmography (PPG), along with heart rate input from the Fitbit’s photodetector device.

It operates only when the user is still or at rest, so overnight use is important for detection, the company noted.

The upcoming Irregular Heart Rhythm Notifications feature will complement the existing ECG app, providing two ways to detect AFib. The ECG app provides a “spot-check approach” in which the users can screen themselves, and the PPG-based feature will allow for long-term heart rhythm assessment, the statement explained.

“Undiagnosed atrial fibrillation can lead to strokes, and early detection of atrial fibrillation may allow doctors to prescribe medications that are effective at preventing strokes,” said Steven A. Lubitz, MD, MPH, a cardiologist at Harvard University and Massachusetts General Hospital, both in Boston, at the AHA meeting.

What causes the dramatic alterations in subjective awareness experienced during a psychedelic “trip?” A new study maps anatomical changes in specific neurotransmitter systems and brain regions that may be responsible for these effects.

Investigators gathered more than 6,800 accounts from individuals who had taken one of 27 different psychedelic compounds. Using a machine learning strategy, they extracted commonly used words from these testimonials, linking them with 40 different neurotransmitter subtypes that had likely induced these experiences.

The investigators then linked these subjective experiences with specific brain regions where the receptor combinations are most commonly found and, using gene transcription probes, created a 3D whole-brain map of the brain receptors and the subjective experiences linked to them.

“Hallucinogenic drugs may very well turn out to be the next big thing to improve clinical care of major mental health conditions,” senior author Danilo Bzdok, MD, PhD, associate professor, McGill University, Montreal, said in a press release.

“Our study provides a first step, a proof of principle, that we may be able to build machine-learning systems in the future that can accurately predict which neurotransmitter receptor combinations need to be stimulated to induce a specific state of conscious experience in a given person,” said Dr. Bzdok, who is also the Canada CIFAR AI Chair at Mila-Quebec Artificial Intelligence Institute.

The study was published online  in Science Advances.
 

‘Unique window’

Psychedelic drugs “show promise” as treatments for various psychiatric disorders, but subjective alterations of reality are “highly variable across individuals” and this “poses a key challenge as we venture to bring hallucinogenic substances into medical practice,” the investigators note.

Although the 5-HT2A receptor has been regarded as a “putative essential mechanism” of hallucinogenic experiences, it is unclear whether the experiential differences are explained by functional selectivity at the 5-HT2A receptor itself or “orchestrated by the vast array of neurotransmitter receptor subclasses on which these drugs act,” they add.

Lead author Galen Ballentine, MD, psychiatry resident, SUNY Downstate Medical Center, Brooklyn, told this news organization that he was “personally eager to find novel ways to identify the neurobiological underpinnings of different states of conscious awareness.”

Psychedelics, he said, offer a “unique window into a vast array of unusual states of consciousness and are particularly useful because they can point toward underlying mechanistic processes that are initiated in specific areas of receptor expression.”

The investigators wanted to understand “how these drugs work in order to help guide their use in clinical practice,” Dr. Ballentine said.

To explore the issue, they undertook the “largest investigation to date into the neuroscience of psychedelic drug experiences,” Dr. Ballentine said. “While most studies are limited to a single drug on a handful of subjects, this project integrates thousands of experiences induced by dozens of different hallucinogenic compounds, viewing them through the prism of 40 receptor subtypes.”
 

Unique neurotransmitter fingerprint

The researchers analyzed 6,850 experience reports of people who had taken 1 of 27 psychedelic compounds. The reports were drawn from a database hosted by the Erowid Center, an organization that collects first-hand accounts of experiences elicited by psychoactive drugs.

The researchers constructed a “bag-of-words” encoding of the text descriptions in each testimonial. Using linguistic calculation methods, they derived a final vocabulary of 14,410 words that they analyzed for descriptive experiential terms.

To shed light on the spatial distribution of these compounds that modulate neuronal activity during subjective “trips,” they compared normalized measurements of their relative binding strengths in 40 sites.

• 5-HT (5-HT2A, 5-HT2C, 5-HT2B, 5-HT1A, 5-HT1B, 5-HT1D, 5-HT1E, 5-HT5A, 5-HT6, 5-HT7)
• Dopamine (D1, D2, D3, D4, D5)
• Adrenergic (a-1A, a-1B, a-2A, a-2B, a-2C, b-1, b-2)
• Serotonin transporter (SERT)
• Dopamine transporter (DAT)
• Norepinephrine transporter (NET)
• Imidazoline-1 receptor (I1)
• Sigma receptors (s-1, s-2)
• d-opioid receptor (DOR)
• k-opioid receptor (KOR)
• m-opioid receptor (MOR)
• Muscarinic receptors (M1, M2, M3, M4, M5)
• Histamine receptors (H1, H2)
• Calcium ion channel (CA+)
• NMDA glutamate receptor

To map receptor-experience factors to regional levels of receptor gene transcription, they utilized human gene expression data drawn from the Allen Human Brain Atlas, as well as the Shafer-Yeo brain atlas.

Via a machine-learning algorithm, they dissected the “phenomenologically rich anecdotes” into a ranking of constituent brain-behavior factors, each of which was characterized by a “unique neurotransmitter fingerprint of action and a unique experiential context” and ultimately created a dimensional map of these neurotransmitter systems.
 

Data-driven framework

Cortex-wide distribution of receptor-experience factors was found in both deep and shallow anatomical brain regions. Regions involved in genetic factor expressions were also wide-ranging, spanning from higher association cortices to unimodal sensory cortices.

The dominant factor “elucidated mystical experience in general and the dissolution of self-world boundaries (ego dissolution) in particular,” the authors report, while the second- and third-most explanatory factors “evoked auditory, visual, and emotional themes of mental expansion.”

Ego dissolution was found to be most associated with the 5-HT2A receptor, as well as other serotonin receptors (5-HT2C, 5-HT1A, 5-HT2B), adrenergic receptors a-2A and b-2, and the D2 receptor.

Alterations in sensory perception were associated with expression of the 5-HT2A receptor in the visual cortex, while modulation of the salience network by dopamine and opioid receptors were implicated in the experience transcendence of space, time, and the structure of self. Auditory hallucinations were linked to a weighted blend of receptors expressed throughout the auditory cortex.

“This data-driven framework identifies patterns that undergird diverse psychedelic experiences such as mystical bliss, existential terror, and complex hallucinations,” Dr. Ballentine commented.

“Simultaneously subjective and neurobiological, these patterns align with the leading hypothesis that psychedelics temporarily diminish top-down control of the most evolutionarily advanced regions of the brain, while at the same time amplifying bottom-up sensory processing from primary sensory cortices,” he added.
 

Forging a new path

Scott Aaronson, MD, chief science officer, Institute for Advanced Diagnostics and Therapeutics and director of the Centre of Excellence at Sheppard Pratt, Towson, Md., said, “As we try to get our arms around understanding the implications of a psychedelic exposure, forward-thinking researchers like Dr. Bzdok et al. are offering interesting ways to capture and understand the experience.”

Dr. Aaronson, an adjunct professor at the University of Maryland School of Medicine who was not involved with the study, continued: “Using the rapidly developing field of natural language processing (NLP), which looks at how language is used for a deeper understanding of human experiences, and combining it with effects of psychedelic compounds on neuronal pathways and neurochemical receptor sites, the authors are forging a new path for further inquiry.” 

In an accompanying editorial, Daniel Barron, MD, PhD, medical director, Interventional Pain Psychiatry Program, Brigham and Women’s Hospital, Boston, and Richard Friedman, MD, professor of clinical psychiatry, Weill Cornell Medical College, New York, call the work “impressive” and “clever.”

“Psychedelics paired with new applications of computational tools might help bypass the imprecision of psychiatric diagnosis and connect measures of behavior to specific physiologic targets,” they write.

The research was supported by the Brain Canada Foundation, through the Canada Brain Research Fund, a grant from the NIH grant, and the Canadian Institutes of Health Research. Dr. Bzdok was also supported by the Healthy Brains Healthy Lives initiative (Canada First Research Excellence fund) and the CIFAR Artificial Intelligence Chairs program (Canada Institute for Advanced Research), as well as Research Award and Teaching Award by Google. The other authors’ disclosures are listed on the original paper. No disclosures were listed for Dr. Barron and Dr. Friedman. Dr. Aaronson’s research is supported by Compass Pathways.

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

What causes the dramatic alterations in subjective awareness experienced during a psychedelic “trip?” A new study maps anatomical changes in specific neurotransmitter systems and brain regions that may be responsible for these effects.

Investigators gathered more than 6,800 accounts from individuals who had taken one of 27 different psychedelic compounds. Using a machine learning strategy, they extracted commonly used words from these testimonials, linking them with 40 different neurotransmitter subtypes that had likely induced these experiences.

The investigators then linked these subjective experiences with specific brain regions where the receptor combinations are most commonly found and, using gene transcription probes, created a 3D whole-brain map of the brain receptors and the subjective experiences linked to them.

“Hallucinogenic drugs may very well turn out to be the next big thing to improve clinical care of major mental health conditions,” senior author Danilo Bzdok, MD, PhD, associate professor, McGill University, Montreal, said in a press release.

“Our study provides a first step, a proof of principle, that we may be able to build machine-learning systems in the future that can accurately predict which neurotransmitter receptor combinations need to be stimulated to induce a specific state of conscious experience in a given person,” said Dr. Bzdok, who is also the Canada CIFAR AI Chair at Mila-Quebec Artificial Intelligence Institute.

The study was published online  in Science Advances.
 

‘Unique window’

Psychedelic drugs “show promise” as treatments for various psychiatric disorders, but subjective alterations of reality are “highly variable across individuals” and this “poses a key challenge as we venture to bring hallucinogenic substances into medical practice,” the investigators note.

Although the 5-HT2A receptor has been regarded as a “putative essential mechanism” of hallucinogenic experiences, it is unclear whether the experiential differences are explained by functional selectivity at the 5-HT2A receptor itself or “orchestrated by the vast array of neurotransmitter receptor subclasses on which these drugs act,” they add.

Lead author Galen Ballentine, MD, psychiatry resident, SUNY Downstate Medical Center, Brooklyn, told this news organization that he was “personally eager to find novel ways to identify the neurobiological underpinnings of different states of conscious awareness.”

Psychedelics, he said, offer a “unique window into a vast array of unusual states of consciousness and are particularly useful because they can point toward underlying mechanistic processes that are initiated in specific areas of receptor expression.”

The investigators wanted to understand “how these drugs work in order to help guide their use in clinical practice,” Dr. Ballentine said.

To explore the issue, they undertook the “largest investigation to date into the neuroscience of psychedelic drug experiences,” Dr. Ballentine said. “While most studies are limited to a single drug on a handful of subjects, this project integrates thousands of experiences induced by dozens of different hallucinogenic compounds, viewing them through the prism of 40 receptor subtypes.”
 

Unique neurotransmitter fingerprint

The researchers analyzed 6,850 experience reports of people who had taken 1 of 27 psychedelic compounds. The reports were drawn from a database hosted by the Erowid Center, an organization that collects first-hand accounts of experiences elicited by psychoactive drugs.

The researchers constructed a “bag-of-words” encoding of the text descriptions in each testimonial. Using linguistic calculation methods, they derived a final vocabulary of 14,410 words that they analyzed for descriptive experiential terms.

To shed light on the spatial distribution of these compounds that modulate neuronal activity during subjective “trips,” they compared normalized measurements of their relative binding strengths in 40 sites.

• 5-HT (5-HT2A, 5-HT2C, 5-HT2B, 5-HT1A, 5-HT1B, 5-HT1D, 5-HT1E, 5-HT5A, 5-HT6, 5-HT7)
• Dopamine (D1, D2, D3, D4, D5)
• Adrenergic (a-1A, a-1B, a-2A, a-2B, a-2C, b-1, b-2)
• Serotonin transporter (SERT)
• Dopamine transporter (DAT)
• Norepinephrine transporter (NET)
• Imidazoline-1 receptor (I1)
• Sigma receptors (s-1, s-2)
• d-opioid receptor (DOR)
• k-opioid receptor (KOR)
• m-opioid receptor (MOR)
• Muscarinic receptors (M1, M2, M3, M4, M5)
• Histamine receptors (H1, H2)
• Calcium ion channel (CA+)
• NMDA glutamate receptor

To map receptor-experience factors to regional levels of receptor gene transcription, they utilized human gene expression data drawn from the Allen Human Brain Atlas, as well as the Shafer-Yeo brain atlas.

Via a machine-learning algorithm, they dissected the “phenomenologically rich anecdotes” into a ranking of constituent brain-behavior factors, each of which was characterized by a “unique neurotransmitter fingerprint of action and a unique experiential context” and ultimately created a dimensional map of these neurotransmitter systems.
 

Data-driven framework

Cortex-wide distribution of receptor-experience factors was found in both deep and shallow anatomical brain regions. Regions involved in genetic factor expressions were also wide-ranging, spanning from higher association cortices to unimodal sensory cortices.

The dominant factor “elucidated mystical experience in general and the dissolution of self-world boundaries (ego dissolution) in particular,” the authors report, while the second- and third-most explanatory factors “evoked auditory, visual, and emotional themes of mental expansion.”

Ego dissolution was found to be most associated with the 5-HT2A receptor, as well as other serotonin receptors (5-HT2C, 5-HT1A, 5-HT2B), adrenergic receptors a-2A and b-2, and the D2 receptor.

Alterations in sensory perception were associated with expression of the 5-HT2A receptor in the visual cortex, while modulation of the salience network by dopamine and opioid receptors were implicated in the experience transcendence of space, time, and the structure of self. Auditory hallucinations were linked to a weighted blend of receptors expressed throughout the auditory cortex.

“This data-driven framework identifies patterns that undergird diverse psychedelic experiences such as mystical bliss, existential terror, and complex hallucinations,” Dr. Ballentine commented.

“Simultaneously subjective and neurobiological, these patterns align with the leading hypothesis that psychedelics temporarily diminish top-down control of the most evolutionarily advanced regions of the brain, while at the same time amplifying bottom-up sensory processing from primary sensory cortices,” he added.
 

Forging a new path

Scott Aaronson, MD, chief science officer, Institute for Advanced Diagnostics and Therapeutics and director of the Centre of Excellence at Sheppard Pratt, Towson, Md., said, “As we try to get our arms around understanding the implications of a psychedelic exposure, forward-thinking researchers like Dr. Bzdok et al. are offering interesting ways to capture and understand the experience.”

Dr. Aaronson, an adjunct professor at the University of Maryland School of Medicine who was not involved with the study, continued: “Using the rapidly developing field of natural language processing (NLP), which looks at how language is used for a deeper understanding of human experiences, and combining it with effects of psychedelic compounds on neuronal pathways and neurochemical receptor sites, the authors are forging a new path for further inquiry.” 

In an accompanying editorial, Daniel Barron, MD, PhD, medical director, Interventional Pain Psychiatry Program, Brigham and Women’s Hospital, Boston, and Richard Friedman, MD, professor of clinical psychiatry, Weill Cornell Medical College, New York, call the work “impressive” and “clever.”

“Psychedelics paired with new applications of computational tools might help bypass the imprecision of psychiatric diagnosis and connect measures of behavior to specific physiologic targets,” they write.

The research was supported by the Brain Canada Foundation, through the Canada Brain Research Fund, a grant from the NIH grant, and the Canadian Institutes of Health Research. Dr. Bzdok was also supported by the Healthy Brains Healthy Lives initiative (Canada First Research Excellence fund) and the CIFAR Artificial Intelligence Chairs program (Canada Institute for Advanced Research), as well as Research Award and Teaching Award by Google. The other authors’ disclosures are listed on the original paper. No disclosures were listed for Dr. Barron and Dr. Friedman. Dr. Aaronson’s research is supported by Compass Pathways.

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

What causes the dramatic alterations in subjective awareness experienced during a psychedelic “trip?” A new study maps anatomical changes in specific neurotransmitter systems and brain regions that may be responsible for these effects.

Investigators gathered more than 6,800 accounts from individuals who had taken one of 27 different psychedelic compounds. Using a machine learning strategy, they extracted commonly used words from these testimonials, linking them with 40 different neurotransmitter subtypes that had likely induced these experiences.

The investigators then linked these subjective experiences with specific brain regions where the receptor combinations are most commonly found and, using gene transcription probes, created a 3D whole-brain map of the brain receptors and the subjective experiences linked to them.

“Hallucinogenic drugs may very well turn out to be the next big thing to improve clinical care of major mental health conditions,” senior author Danilo Bzdok, MD, PhD, associate professor, McGill University, Montreal, said in a press release.

“Our study provides a first step, a proof of principle, that we may be able to build machine-learning systems in the future that can accurately predict which neurotransmitter receptor combinations need to be stimulated to induce a specific state of conscious experience in a given person,” said Dr. Bzdok, who is also the Canada CIFAR AI Chair at Mila-Quebec Artificial Intelligence Institute.

The study was published online  in Science Advances.
 

‘Unique window’

Psychedelic drugs “show promise” as treatments for various psychiatric disorders, but subjective alterations of reality are “highly variable across individuals” and this “poses a key challenge as we venture to bring hallucinogenic substances into medical practice,” the investigators note.

Although the 5-HT2A receptor has been regarded as a “putative essential mechanism” of hallucinogenic experiences, it is unclear whether the experiential differences are explained by functional selectivity at the 5-HT2A receptor itself or “orchestrated by the vast array of neurotransmitter receptor subclasses on which these drugs act,” they add.

Lead author Galen Ballentine, MD, psychiatry resident, SUNY Downstate Medical Center, Brooklyn, told this news organization that he was “personally eager to find novel ways to identify the neurobiological underpinnings of different states of conscious awareness.”

Psychedelics, he said, offer a “unique window into a vast array of unusual states of consciousness and are particularly useful because they can point toward underlying mechanistic processes that are initiated in specific areas of receptor expression.”

The investigators wanted to understand “how these drugs work in order to help guide their use in clinical practice,” Dr. Ballentine said.

To explore the issue, they undertook the “largest investigation to date into the neuroscience of psychedelic drug experiences,” Dr. Ballentine said. “While most studies are limited to a single drug on a handful of subjects, this project integrates thousands of experiences induced by dozens of different hallucinogenic compounds, viewing them through the prism of 40 receptor subtypes.”
 

Unique neurotransmitter fingerprint

The researchers analyzed 6,850 experience reports of people who had taken 1 of 27 psychedelic compounds. The reports were drawn from a database hosted by the Erowid Center, an organization that collects first-hand accounts of experiences elicited by psychoactive drugs.

The researchers constructed a “bag-of-words” encoding of the text descriptions in each testimonial. Using linguistic calculation methods, they derived a final vocabulary of 14,410 words that they analyzed for descriptive experiential terms.

To shed light on the spatial distribution of these compounds that modulate neuronal activity during subjective “trips,” they compared normalized measurements of their relative binding strengths in 40 sites.

• 5-HT (5-HT2A, 5-HT2C, 5-HT2B, 5-HT1A, 5-HT1B, 5-HT1D, 5-HT1E, 5-HT5A, 5-HT6, 5-HT7)
• Dopamine (D1, D2, D3, D4, D5)
• Adrenergic (a-1A, a-1B, a-2A, a-2B, a-2C, b-1, b-2)
• Serotonin transporter (SERT)
• Dopamine transporter (DAT)
• Norepinephrine transporter (NET)
• Imidazoline-1 receptor (I1)
• Sigma receptors (s-1, s-2)
• d-opioid receptor (DOR)
• k-opioid receptor (KOR)
• m-opioid receptor (MOR)
• Muscarinic receptors (M1, M2, M3, M4, M5)
• Histamine receptors (H1, H2)
• Calcium ion channel (CA+)
• NMDA glutamate receptor

To map receptor-experience factors to regional levels of receptor gene transcription, they utilized human gene expression data drawn from the Allen Human Brain Atlas, as well as the Shafer-Yeo brain atlas.

Via a machine-learning algorithm, they dissected the “phenomenologically rich anecdotes” into a ranking of constituent brain-behavior factors, each of which was characterized by a “unique neurotransmitter fingerprint of action and a unique experiential context” and ultimately created a dimensional map of these neurotransmitter systems.
 

Data-driven framework

Cortex-wide distribution of receptor-experience factors was found in both deep and shallow anatomical brain regions. Regions involved in genetic factor expressions were also wide-ranging, spanning from higher association cortices to unimodal sensory cortices.

The dominant factor “elucidated mystical experience in general and the dissolution of self-world boundaries (ego dissolution) in particular,” the authors report, while the second- and third-most explanatory factors “evoked auditory, visual, and emotional themes of mental expansion.”

Ego dissolution was found to be most associated with the 5-HT2A receptor, as well as other serotonin receptors (5-HT2C, 5-HT1A, 5-HT2B), adrenergic receptors a-2A and b-2, and the D2 receptor.

Alterations in sensory perception were associated with expression of the 5-HT2A receptor in the visual cortex, while modulation of the salience network by dopamine and opioid receptors were implicated in the experience transcendence of space, time, and the structure of self. Auditory hallucinations were linked to a weighted blend of receptors expressed throughout the auditory cortex.

“This data-driven framework identifies patterns that undergird diverse psychedelic experiences such as mystical bliss, existential terror, and complex hallucinations,” Dr. Ballentine commented.

“Simultaneously subjective and neurobiological, these patterns align with the leading hypothesis that psychedelics temporarily diminish top-down control of the most evolutionarily advanced regions of the brain, while at the same time amplifying bottom-up sensory processing from primary sensory cortices,” he added.
 

Forging a new path

Scott Aaronson, MD, chief science officer, Institute for Advanced Diagnostics and Therapeutics and director of the Centre of Excellence at Sheppard Pratt, Towson, Md., said, “As we try to get our arms around understanding the implications of a psychedelic exposure, forward-thinking researchers like Dr. Bzdok et al. are offering interesting ways to capture and understand the experience.”

Dr. Aaronson, an adjunct professor at the University of Maryland School of Medicine who was not involved with the study, continued: “Using the rapidly developing field of natural language processing (NLP), which looks at how language is used for a deeper understanding of human experiences, and combining it with effects of psychedelic compounds on neuronal pathways and neurochemical receptor sites, the authors are forging a new path for further inquiry.” 

In an accompanying editorial, Daniel Barron, MD, PhD, medical director, Interventional Pain Psychiatry Program, Brigham and Women’s Hospital, Boston, and Richard Friedman, MD, professor of clinical psychiatry, Weill Cornell Medical College, New York, call the work “impressive” and “clever.”

“Psychedelics paired with new applications of computational tools might help bypass the imprecision of psychiatric diagnosis and connect measures of behavior to specific physiologic targets,” they write.

The research was supported by the Brain Canada Foundation, through the Canada Brain Research Fund, a grant from the NIH grant, and the Canadian Institutes of Health Research. Dr. Bzdok was also supported by the Healthy Brains Healthy Lives initiative (Canada First Research Excellence fund) and the CIFAR Artificial Intelligence Chairs program (Canada Institute for Advanced Research), as well as Research Award and Teaching Award by Google. The other authors’ disclosures are listed on the original paper. No disclosures were listed for Dr. Barron and Dr. Friedman. Dr. Aaronson’s research is supported by Compass Pathways.

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

The number of overdose deaths in adolescents nearly doubled in 2020 from the year before and increased substantially again in 2021 after nearly a decade of fairly stable rates, according to data published in a JAMA research letter.

Most of the deaths involved fentanyl, the researchers found.

Joseph Friedman, MPH, of the Center for Social Medicine and Humanities at the University of California, Los Angeles, led the study, which analyzed adolescent (14-18 years old) overdose deaths in the United States from 2010 to June 2021 in light of increasing contamination in the supply of illicit drugs.

The researchers found there were 518 deaths among adolescents (2.40 per 100,000 population) in 2010, and the rates remained stable through 2019 with 492 deaths (2.36 per 100,000).

In 2020, however, deaths spiked to 954 (4.57 per 100 000), increasing by 94.3%, compared with 2019. In 2021, they increased another 20%.

The rise in fentanyl-involved deaths was particularly striking. Fentanyl-involved deaths increased from 253 (1.21 per 100,000) in 2019 to 680 (3.26 per 100,000) in 2020. The numbers through June 2021 were annualized for 2021 and calculations predicted 884 deaths (4.23 per 100,000) for the year.
 

Numbers point to fentanyl potency

In 2021, more than three-fourths (77.14%) of adolescent overdose deaths involved fentanyl, compared with 13.26% for benzodiazepines, 9.77% for methamphetamine, 7.33% for cocaine, 5.76% for prescription opioids, and 2.27% for heroin.

American Indian and Alaska Native adolescents had the highest overdose rate in 2021 (n = 24; 11.79 per 100,000), followed by Latinx adolescents (n = 354; 6.98 per 100,000).

“These adolescent trends fit a wider pattern of increasing racial and ethnic inequalities in overdose that deserve further investigation and intervention efforts,” the authors wrote.
 

Pandemic’s role unclear

The spikes in adolescent overdoses overlap the COVID-19 pandemic, but Dr. Friedman said in an interview the pandemic “may or may not have been a big factor. “

The authors wrote that drug use had generally been stable among adolescents between 2010 and 2020. The number of 10th graders reporting any illicit drug use was 30.2% in 2010 and 30.4% in 2020.

“So it’s not that more teens are using drugs. It’s just that drug use is becoming more dangerous due to the spread of counterfeit pills containing fentanyls,” Dr. Friedman said.

The authors noted that “the illicit drug supply has increasingly become contaminated with illicitly manufactured fentanyls and other synthetic opioid and benzodiazepine analogues.”

Mr. Friedman said the pandemic may have accelerated the spread of more dangerous forms of drugs as supply chains were disrupted.

Benjamin Brady, DrPH, an assistant professor at the University of Arizona, Tucson, who also has an appointment in the university’s Comprehensive Pain and Addiction Center, said in an interview the numbers that Dr. Friedman and colleagues present represent “worst fears coming true.”

He said he and his colleagues in the field “were anticipating a rise in overdose deaths for the next 5-10 years because of the way the supply-and-demand environment exists in the U.S.”

Dr. Brady explained that restricting access to prescription opioids has had an unfortunate side effect in decreasing access to a safer supply of drugs.

“Without having solutions that would reduce demand at the same rate, supply of the safer form of the drug has been reduced; that has pushed people toward heroin and street drugs and from 2016 on those have been adulterated with fentanyl,” he said.

He said the United States, compared with other developed nations, has been slower to embrace longer-term harm-reduction strategies and to improve access to treatment and care.

COVID likely also has exacerbated the problem in terms of isolation and reduction in quality of life that has adolescents seeking to fill that void with drugs, Dr. Brady said. They may be completely unaware that the drugs they are seeking are commonly cut with counterfeit fentanyl.

“Fentanyl can be up to 50 times stronger than heroin,” he noted. “Even just a little bit of fentanyl dramatically changes the risk profile on an overdose.”

Increasing rates of mental health concerns among adolescents over decades also contribute to drug-seeking trends, Dr. Brady noted.
 

Overdose increases in the overall population were smaller

In the overall population, the percentage increases were not nearly as large in 2020 and 2021 as they were for adolescents.

Rates of overdose deaths in the overall population increased steadily from 2010 and reached 70,630 in 2019. In 2020, the deaths increased to 91,799 (an increase of 29.48% from 2019) and increased 11.48% in 2021.

The researchers analyzed numbers from the Centers for Disease Control and Prevention WONDER (Wide-Ranging Online Data for Epidemiologic Research) database, which has records of all U.S. deaths for which drug overdose was listed as the underlying cause.

The authors and Dr. Brady report no relevant financial relationships.

The number of overdose deaths in adolescents nearly doubled in 2020 from the year before and increased substantially again in 2021 after nearly a decade of fairly stable rates, according to data published in a JAMA research letter.

Most of the deaths involved fentanyl, the researchers found.

Joseph Friedman, MPH, of the Center for Social Medicine and Humanities at the University of California, Los Angeles, led the study, which analyzed adolescent (14-18 years old) overdose deaths in the United States from 2010 to June 2021 in light of increasing contamination in the supply of illicit drugs.

The researchers found there were 518 deaths among adolescents (2.40 per 100,000 population) in 2010, and the rates remained stable through 2019 with 492 deaths (2.36 per 100,000).

In 2020, however, deaths spiked to 954 (4.57 per 100 000), increasing by 94.3%, compared with 2019. In 2021, they increased another 20%.

The rise in fentanyl-involved deaths was particularly striking. Fentanyl-involved deaths increased from 253 (1.21 per 100,000) in 2019 to 680 (3.26 per 100,000) in 2020. The numbers through June 2021 were annualized for 2021 and calculations predicted 884 deaths (4.23 per 100,000) for the year.
 

Numbers point to fentanyl potency

In 2021, more than three-fourths (77.14%) of adolescent overdose deaths involved fentanyl, compared with 13.26% for benzodiazepines, 9.77% for methamphetamine, 7.33% for cocaine, 5.76% for prescription opioids, and 2.27% for heroin.

American Indian and Alaska Native adolescents had the highest overdose rate in 2021 (n = 24; 11.79 per 100,000), followed by Latinx adolescents (n = 354; 6.98 per 100,000).

“These adolescent trends fit a wider pattern of increasing racial and ethnic inequalities in overdose that deserve further investigation and intervention efforts,” the authors wrote.
 

Pandemic’s role unclear

The spikes in adolescent overdoses overlap the COVID-19 pandemic, but Dr. Friedman said in an interview the pandemic “may or may not have been a big factor. “

The authors wrote that drug use had generally been stable among adolescents between 2010 and 2020. The number of 10th graders reporting any illicit drug use was 30.2% in 2010 and 30.4% in 2020.

“So it’s not that more teens are using drugs. It’s just that drug use is becoming more dangerous due to the spread of counterfeit pills containing fentanyls,” Dr. Friedman said.

The authors noted that “the illicit drug supply has increasingly become contaminated with illicitly manufactured fentanyls and other synthetic opioid and benzodiazepine analogues.”

Mr. Friedman said the pandemic may have accelerated the spread of more dangerous forms of drugs as supply chains were disrupted.

Benjamin Brady, DrPH, an assistant professor at the University of Arizona, Tucson, who also has an appointment in the university’s Comprehensive Pain and Addiction Center, said in an interview the numbers that Dr. Friedman and colleagues present represent “worst fears coming true.”

He said he and his colleagues in the field “were anticipating a rise in overdose deaths for the next 5-10 years because of the way the supply-and-demand environment exists in the U.S.”

Dr. Brady explained that restricting access to prescription opioids has had an unfortunate side effect in decreasing access to a safer supply of drugs.

“Without having solutions that would reduce demand at the same rate, supply of the safer form of the drug has been reduced; that has pushed people toward heroin and street drugs and from 2016 on those have been adulterated with fentanyl,” he said.

He said the United States, compared with other developed nations, has been slower to embrace longer-term harm-reduction strategies and to improve access to treatment and care.

COVID likely also has exacerbated the problem in terms of isolation and reduction in quality of life that has adolescents seeking to fill that void with drugs, Dr. Brady said. They may be completely unaware that the drugs they are seeking are commonly cut with counterfeit fentanyl.

“Fentanyl can be up to 50 times stronger than heroin,” he noted. “Even just a little bit of fentanyl dramatically changes the risk profile on an overdose.”

Increasing rates of mental health concerns among adolescents over decades also contribute to drug-seeking trends, Dr. Brady noted.
 

Overdose increases in the overall population were smaller

In the overall population, the percentage increases were not nearly as large in 2020 and 2021 as they were for adolescents.

Rates of overdose deaths in the overall population increased steadily from 2010 and reached 70,630 in 2019. In 2020, the deaths increased to 91,799 (an increase of 29.48% from 2019) and increased 11.48% in 2021.

The researchers analyzed numbers from the Centers for Disease Control and Prevention WONDER (Wide-Ranging Online Data for Epidemiologic Research) database, which has records of all U.S. deaths for which drug overdose was listed as the underlying cause.

The authors and Dr. Brady report no relevant financial relationships.

The number of overdose deaths in adolescents nearly doubled in 2020 from the year before and increased substantially again in 2021 after nearly a decade of fairly stable rates, according to data published in a JAMA research letter.

Most of the deaths involved fentanyl, the researchers found.

Joseph Friedman, MPH, of the Center for Social Medicine and Humanities at the University of California, Los Angeles, led the study, which analyzed adolescent (14-18 years old) overdose deaths in the United States from 2010 to June 2021 in light of increasing contamination in the supply of illicit drugs.

The researchers found there were 518 deaths among adolescents (2.40 per 100,000 population) in 2010, and the rates remained stable through 2019 with 492 deaths (2.36 per 100,000).

In 2020, however, deaths spiked to 954 (4.57 per 100 000), increasing by 94.3%, compared with 2019. In 2021, they increased another 20%.

The rise in fentanyl-involved deaths was particularly striking. Fentanyl-involved deaths increased from 253 (1.21 per 100,000) in 2019 to 680 (3.26 per 100,000) in 2020. The numbers through June 2021 were annualized for 2021 and calculations predicted 884 deaths (4.23 per 100,000) for the year.
 

Numbers point to fentanyl potency

In 2021, more than three-fourths (77.14%) of adolescent overdose deaths involved fentanyl, compared with 13.26% for benzodiazepines, 9.77% for methamphetamine, 7.33% for cocaine, 5.76% for prescription opioids, and 2.27% for heroin.

American Indian and Alaska Native adolescents had the highest overdose rate in 2021 (n = 24; 11.79 per 100,000), followed by Latinx adolescents (n = 354; 6.98 per 100,000).

“These adolescent trends fit a wider pattern of increasing racial and ethnic inequalities in overdose that deserve further investigation and intervention efforts,” the authors wrote.
 

Pandemic’s role unclear

The spikes in adolescent overdoses overlap the COVID-19 pandemic, but Dr. Friedman said in an interview the pandemic “may or may not have been a big factor. “

The authors wrote that drug use had generally been stable among adolescents between 2010 and 2020. The number of 10th graders reporting any illicit drug use was 30.2% in 2010 and 30.4% in 2020.

“So it’s not that more teens are using drugs. It’s just that drug use is becoming more dangerous due to the spread of counterfeit pills containing fentanyls,” Dr. Friedman said.

The authors noted that “the illicit drug supply has increasingly become contaminated with illicitly manufactured fentanyls and other synthetic opioid and benzodiazepine analogues.”

Mr. Friedman said the pandemic may have accelerated the spread of more dangerous forms of drugs as supply chains were disrupted.

Benjamin Brady, DrPH, an assistant professor at the University of Arizona, Tucson, who also has an appointment in the university’s Comprehensive Pain and Addiction Center, said in an interview the numbers that Dr. Friedman and colleagues present represent “worst fears coming true.”

He said he and his colleagues in the field “were anticipating a rise in overdose deaths for the next 5-10 years because of the way the supply-and-demand environment exists in the U.S.”

Dr. Brady explained that restricting access to prescription opioids has had an unfortunate side effect in decreasing access to a safer supply of drugs.

“Without having solutions that would reduce demand at the same rate, supply of the safer form of the drug has been reduced; that has pushed people toward heroin and street drugs and from 2016 on those have been adulterated with fentanyl,” he said.

He said the United States, compared with other developed nations, has been slower to embrace longer-term harm-reduction strategies and to improve access to treatment and care.

COVID likely also has exacerbated the problem in terms of isolation and reduction in quality of life that has adolescents seeking to fill that void with drugs, Dr. Brady said. They may be completely unaware that the drugs they are seeking are commonly cut with counterfeit fentanyl.

“Fentanyl can be up to 50 times stronger than heroin,” he noted. “Even just a little bit of fentanyl dramatically changes the risk profile on an overdose.”

Increasing rates of mental health concerns among adolescents over decades also contribute to drug-seeking trends, Dr. Brady noted.
 

Overdose increases in the overall population were smaller

In the overall population, the percentage increases were not nearly as large in 2020 and 2021 as they were for adolescents.

Rates of overdose deaths in the overall population increased steadily from 2010 and reached 70,630 in 2019. In 2020, the deaths increased to 91,799 (an increase of 29.48% from 2019) and increased 11.48% in 2021.

The researchers analyzed numbers from the Centers for Disease Control and Prevention WONDER (Wide-Ranging Online Data for Epidemiologic Research) database, which has records of all U.S. deaths for which drug overdose was listed as the underlying cause.

The authors and Dr. Brady report no relevant financial relationships.

Similar outcomes in patients with ventilator-associated pneumonia (VAP) suggest that antibiotics selected by Gram staining were noninferior to those based on guidelines and also significantly decreased the use of broad-spectrum antibiotics in this patient population.

The findings were published  in JAMA Network Open. The multicenter, open-label, noninferiority, randomized trial, Gram Stain-Guided Antibiotics Choice for VAP (GRACE-VAP), was conducted for 2 years in intensive care units (ICUs) of a dozen tertiary referral hospitals in Japan, from April 1, 2018, through May 31, 2020.

The authors noted in their paper that the 2016 clinical practice guidelines for VAP published by the Infectious Diseases Society of America (IDSA) and the American Thoracic Society recommend antibiotic agents active against both methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa as an empirical treatment. Adherence to these guidelines may lead to overuse of broad-spectrum antibiotic agents and could be associated with the accelerated emergence of antimicrobial-resistant organisms, the authors postulated.

The study sought to answer the question: Can Gram staining be used as an alternative to established guidelines to direct antibiotic use – thereby curbing the use of broad-spectrum antibiotics – without compromising patient safety and clinical outcomes?

A total of 206 patients, with a mean age of 69, took part in the study. The same number of patients were assigned to each arm. Patients aged 15 years or older with a VAP diagnosis and a modified Clinical Pulmonary Infection Score of 5 or higher were included.

Investigators reported that 79 patients (76.7%) responded to antibiotics in the Gram stain-guided group and 74 (71.8%) responded in the guideline-based group (risk difference, 0.05; 95% confidence interval, –0.07 to 0.17; P < .001, for noninferiority).

There was a decrease in antipseudomonal agent use comparing the Gram stain-guided group with the guideline-based group (30.1%; 95% CI, 21.5% to 39.9%; P < .001). There also was a decrease in anti-MRSA agents in the Gram stain-guided group, compared with the guideline-based group (38.8%; 95% CI, 29.4% to 48.9%; P < .001).

The 28-day cumulative incidence of mortality was 13.6% (n = 14) in the Gram stain-guided group versus 17.5% (n = 18) in the guideline-based group. Escalation of antibiotics according to culture results was performed in seven patients (6.8%) in the Gram stain-guided group and in one patient (1.0%) in the guideline-based group. No significant differences in study arms were observed on other measures, such as ICU-free days, ventilator-free days, and adverse events.

The authors concluded that their findings support the use of Gram staining as a strategy to manage infectious diseases and contain the development of multidrug resistant organisms (MDROs) in the setting of critical care.

“In the GRACE-VAP trial, we used the time-honored Gram stain technique as part of the daily management of infectious diseases. We believe that the trial results are acceptable and have the potential to change the strategy of antibiotic choice worldwide,” the authors wrote.

Benjamin D. Galvan MLS(ASCP), CIC, an infection preventionist with a professional background in clinical microbiology, noted that Gram staining is more accessible and significantly less costly than the rapid polymerase chain reaction testing certain institutions use to rapidly identify MDROs to help tailor therapy.

But one of the pitfalls with relying on Gram stain collection to guide antibiotic use is that it is operator dependent and subject to extrinsic factors, like prior antibiotic use, he pointed out.

“If it is not collected, set up, and read properly, the Gram stain is not going to necessarily be reliable” said Mr. Galvan, also a member of the national communications committee for the Association for Professionals in Infection Control and Epidemiology. He added that the sample in the study was not representative of institutions dealing with elevated rates of multidrug resistance.

“Even from their own results, they were looking at hospitals that have a low rate of multidrug resistance,” he said. “It was not clear if MRSA or just Staphylococcus aureus was identified in significant quantities upon review, and they recognized a lower-than-expected number of isolates of Pseudomonas aeruginosa.”

Establishing antibiotic treatment from the results of Gram-stain collection may not be sufficiently comprehensive, he said.

“Generally speaking, basing it (antibiotic therapy) solely off of a Gram stain is not looking at the whole picture,” said Mr. Galvan, noting that the 2016 IDSA guidelines call for an evaluation of the clinical status, including risk, of the individual patient, as well as locally available antibiotic resistance data.

Moreover, the evidence-based IDSA guidelines are in place to help address the issue of antimicrobial resistance trends, already recommending tailoring empiric antibiotic therapy based upon the levels of resistance in the local population, according to Galvan.

While the study suggests that this Gram-stain-driven tailoring of empiric antibiotic therapy may be noninferior to current guidelines in health care settings with low MDRO rates, its utility may not be suitable in hospitals that are already dealing with high rates of MDROs, such as Pseudomonas aeruginosa and Acinetobacter baumannii, or severe clinical cases of VAP, Mr. Galvan explained.

The researchers and Mr. Galvan disclosed no relevant financial relationships.

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

Similar outcomes in patients with ventilator-associated pneumonia (VAP) suggest that antibiotics selected by Gram staining were noninferior to those based on guidelines and also significantly decreased the use of broad-spectrum antibiotics in this patient population.

The findings were published  in JAMA Network Open. The multicenter, open-label, noninferiority, randomized trial, Gram Stain-Guided Antibiotics Choice for VAP (GRACE-VAP), was conducted for 2 years in intensive care units (ICUs) of a dozen tertiary referral hospitals in Japan, from April 1, 2018, through May 31, 2020.

The authors noted in their paper that the 2016 clinical practice guidelines for VAP published by the Infectious Diseases Society of America (IDSA) and the American Thoracic Society recommend antibiotic agents active against both methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa as an empirical treatment. Adherence to these guidelines may lead to overuse of broad-spectrum antibiotic agents and could be associated with the accelerated emergence of antimicrobial-resistant organisms, the authors postulated.

The study sought to answer the question: Can Gram staining be used as an alternative to established guidelines to direct antibiotic use – thereby curbing the use of broad-spectrum antibiotics – without compromising patient safety and clinical outcomes?

A total of 206 patients, with a mean age of 69, took part in the study. The same number of patients were assigned to each arm. Patients aged 15 years or older with a VAP diagnosis and a modified Clinical Pulmonary Infection Score of 5 or higher were included.

Investigators reported that 79 patients (76.7%) responded to antibiotics in the Gram stain-guided group and 74 (71.8%) responded in the guideline-based group (risk difference, 0.05; 95% confidence interval, –0.07 to 0.17; P < .001, for noninferiority).

There was a decrease in antipseudomonal agent use comparing the Gram stain-guided group with the guideline-based group (30.1%; 95% CI, 21.5% to 39.9%; P < .001). There also was a decrease in anti-MRSA agents in the Gram stain-guided group, compared with the guideline-based group (38.8%; 95% CI, 29.4% to 48.9%; P < .001).

The 28-day cumulative incidence of mortality was 13.6% (n = 14) in the Gram stain-guided group versus 17.5% (n = 18) in the guideline-based group. Escalation of antibiotics according to culture results was performed in seven patients (6.8%) in the Gram stain-guided group and in one patient (1.0%) in the guideline-based group. No significant differences in study arms were observed on other measures, such as ICU-free days, ventilator-free days, and adverse events.

The authors concluded that their findings support the use of Gram staining as a strategy to manage infectious diseases and contain the development of multidrug resistant organisms (MDROs) in the setting of critical care.

“In the GRACE-VAP trial, we used the time-honored Gram stain technique as part of the daily management of infectious diseases. We believe that the trial results are acceptable and have the potential to change the strategy of antibiotic choice worldwide,” the authors wrote.

Benjamin D. Galvan MLS(ASCP), CIC, an infection preventionist with a professional background in clinical microbiology, noted that Gram staining is more accessible and significantly less costly than the rapid polymerase chain reaction testing certain institutions use to rapidly identify MDROs to help tailor therapy.

But one of the pitfalls with relying on Gram stain collection to guide antibiotic use is that it is operator dependent and subject to extrinsic factors, like prior antibiotic use, he pointed out.

“If it is not collected, set up, and read properly, the Gram stain is not going to necessarily be reliable” said Mr. Galvan, also a member of the national communications committee for the Association for Professionals in Infection Control and Epidemiology. He added that the sample in the study was not representative of institutions dealing with elevated rates of multidrug resistance.

“Even from their own results, they were looking at hospitals that have a low rate of multidrug resistance,” he said. “It was not clear if MRSA or just Staphylococcus aureus was identified in significant quantities upon review, and they recognized a lower-than-expected number of isolates of Pseudomonas aeruginosa.”

Establishing antibiotic treatment from the results of Gram-stain collection may not be sufficiently comprehensive, he said.

“Generally speaking, basing it (antibiotic therapy) solely off of a Gram stain is not looking at the whole picture,” said Mr. Galvan, noting that the 2016 IDSA guidelines call for an evaluation of the clinical status, including risk, of the individual patient, as well as locally available antibiotic resistance data.

Moreover, the evidence-based IDSA guidelines are in place to help address the issue of antimicrobial resistance trends, already recommending tailoring empiric antibiotic therapy based upon the levels of resistance in the local population, according to Galvan.

While the study suggests that this Gram-stain-driven tailoring of empiric antibiotic therapy may be noninferior to current guidelines in health care settings with low MDRO rates, its utility may not be suitable in hospitals that are already dealing with high rates of MDROs, such as Pseudomonas aeruginosa and Acinetobacter baumannii, or severe clinical cases of VAP, Mr. Galvan explained.

The researchers and Mr. Galvan disclosed no relevant financial relationships.

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

Similar outcomes in patients with ventilator-associated pneumonia (VAP) suggest that antibiotics selected by Gram staining were noninferior to those based on guidelines and also significantly decreased the use of broad-spectrum antibiotics in this patient population.

The findings were published  in JAMA Network Open. The multicenter, open-label, noninferiority, randomized trial, Gram Stain-Guided Antibiotics Choice for VAP (GRACE-VAP), was conducted for 2 years in intensive care units (ICUs) of a dozen tertiary referral hospitals in Japan, from April 1, 2018, through May 31, 2020.

The authors noted in their paper that the 2016 clinical practice guidelines for VAP published by the Infectious Diseases Society of America (IDSA) and the American Thoracic Society recommend antibiotic agents active against both methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa as an empirical treatment. Adherence to these guidelines may lead to overuse of broad-spectrum antibiotic agents and could be associated with the accelerated emergence of antimicrobial-resistant organisms, the authors postulated.

The study sought to answer the question: Can Gram staining be used as an alternative to established guidelines to direct antibiotic use – thereby curbing the use of broad-spectrum antibiotics – without compromising patient safety and clinical outcomes?

A total of 206 patients, with a mean age of 69, took part in the study. The same number of patients were assigned to each arm. Patients aged 15 years or older with a VAP diagnosis and a modified Clinical Pulmonary Infection Score of 5 or higher were included.

Investigators reported that 79 patients (76.7%) responded to antibiotics in the Gram stain-guided group and 74 (71.8%) responded in the guideline-based group (risk difference, 0.05; 95% confidence interval, –0.07 to 0.17; P < .001, for noninferiority).

There was a decrease in antipseudomonal agent use comparing the Gram stain-guided group with the guideline-based group (30.1%; 95% CI, 21.5% to 39.9%; P < .001). There also was a decrease in anti-MRSA agents in the Gram stain-guided group, compared with the guideline-based group (38.8%; 95% CI, 29.4% to 48.9%; P < .001).

The 28-day cumulative incidence of mortality was 13.6% (n = 14) in the Gram stain-guided group versus 17.5% (n = 18) in the guideline-based group. Escalation of antibiotics according to culture results was performed in seven patients (6.8%) in the Gram stain-guided group and in one patient (1.0%) in the guideline-based group. No significant differences in study arms were observed on other measures, such as ICU-free days, ventilator-free days, and adverse events.

The authors concluded that their findings support the use of Gram staining as a strategy to manage infectious diseases and contain the development of multidrug resistant organisms (MDROs) in the setting of critical care.

“In the GRACE-VAP trial, we used the time-honored Gram stain technique as part of the daily management of infectious diseases. We believe that the trial results are acceptable and have the potential to change the strategy of antibiotic choice worldwide,” the authors wrote.

Benjamin D. Galvan MLS(ASCP), CIC, an infection preventionist with a professional background in clinical microbiology, noted that Gram staining is more accessible and significantly less costly than the rapid polymerase chain reaction testing certain institutions use to rapidly identify MDROs to help tailor therapy.

But one of the pitfalls with relying on Gram stain collection to guide antibiotic use is that it is operator dependent and subject to extrinsic factors, like prior antibiotic use, he pointed out.

“If it is not collected, set up, and read properly, the Gram stain is not going to necessarily be reliable” said Mr. Galvan, also a member of the national communications committee for the Association for Professionals in Infection Control and Epidemiology. He added that the sample in the study was not representative of institutions dealing with elevated rates of multidrug resistance.

“Even from their own results, they were looking at hospitals that have a low rate of multidrug resistance,” he said. “It was not clear if MRSA or just Staphylococcus aureus was identified in significant quantities upon review, and they recognized a lower-than-expected number of isolates of Pseudomonas aeruginosa.”

Establishing antibiotic treatment from the results of Gram-stain collection may not be sufficiently comprehensive, he said.

“Generally speaking, basing it (antibiotic therapy) solely off of a Gram stain is not looking at the whole picture,” said Mr. Galvan, noting that the 2016 IDSA guidelines call for an evaluation of the clinical status, including risk, of the individual patient, as well as locally available antibiotic resistance data.

Moreover, the evidence-based IDSA guidelines are in place to help address the issue of antimicrobial resistance trends, already recommending tailoring empiric antibiotic therapy based upon the levels of resistance in the local population, according to Galvan.

While the study suggests that this Gram-stain-driven tailoring of empiric antibiotic therapy may be noninferior to current guidelines in health care settings with low MDRO rates, its utility may not be suitable in hospitals that are already dealing with high rates of MDROs, such as Pseudomonas aeruginosa and Acinetobacter baumannii, or severe clinical cases of VAP, Mr. Galvan explained.

The researchers and Mr. Galvan disclosed no relevant financial relationships.

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

Structural aortic valve deterioration (SVD) at 5 years is lower following repair with a contemporary transcatheter implantation (TAVI) device than with surgery, according to a pooled analysis of major trials.

For healthier patients with a relatively long life expectancy, this is important information for deciding whether to undergo TAVI or surgical aortic valve repair (SAVR), Michael J. Reardon, MD, said at the annual scientific sessions of the American College of Cardiology.

“Every week I get this question about which repair is more durable,” said Dr. Reardon, whose study was not only designed to compare device deterioration but to evaluate the effect of SVD on major outcomes.

In this analysis, the rates of SVD were compared for the self-expanding supra-annular CoreValve Evolut device and SAVR. The SVD curves separated within the first year. At 5 years, the differences were highly significant favoring TAVI (2.57% vs. 4.38%; P = .0095).

As part of this analysis, the impact of SVD was also assessed independent of type of repair. At 5 years, those with SVD relative to those without had an approximately twofold increase in all-cause mortality, cardiovascular mortality, and hospitalization of aortic valve worsening. These risks were elevated regardless of type of valve repair.

The data presented by Dr. Reardon can be considered device specific. The earlier PARTNER 2A study comparing older- and newer-generation TAVI devices with SAVR produced a different result. When a second-generation balloon-expandable SAPIEN XT device and a third-generation SAPIEN 3 device were compared with surgery, neither device achieved lower SVD rates relative to SAVR.

In PARTNER 2A, the SVD rate for the older device was nearly three times greater than SAVR (1.61 vs. 0.58 per 100 patient-years). The numerically higher SVD rates for the newer device (0.68 vs. 0.58 per 100 patient-years) was not statistically different, but the TAVI device was not superior.

More than 4,000 patients evaluated at 5 years

In the analysis presented by Dr. Reardon, data were pooled from the randomized CoreValve U.S. High-Risk Pivotal Trial and the SURTAVI Intermediate Risk Trial. Together, these studies randomized 971 patients to surgery and 1,128 patients to TAVI. Data on an additional 2,663 patients treated with the Evolut valve in two registries were added to the randomized trial data, providing data on 4,762 total patients with 5-year follow-up.

SVD was defined by two criteria. The first was a mean gradient increase of at least 10 mm Hg plus a mean overall gradient of at least 20 mm Hg as measured with echocardiography and assessed, when possible, by an independent core laboratory. The second was new-onset or increased intraprosthetic aortic regurgitation of at least moderate severity.

When graphed over time, the SVD curves separated in favor of TAVI after about 6 months of follow-up. The shape of the curves also differed. Unlike the steady rise in SVD observed in the surgery group, the SVD rate in the TAVI group remained below 1% for almost 4 years before beginning to climb.

There was greater relative benefit for the TAVI device in patients with annular diameters of 23 mm or less. Unlike the rise in SVD rates that began about 6 months after SAVR, the SVD rates in the TAVI patients remained at 0% for more than 2 years. At 5 years, the differences remained significant favoring TAVI (1.39% vs. 5.86%; P = .049).

In those with larger annular diameters, there was still a consistently lower SVD rate over time for TAVI relative to SAVR, but the trend for an advantage at 5 years fell just short of significance (2.48% vs. 3.96%; P = .067).
 

SVD linked to doubling of mortality

SVD worsened outcomes. When all data surgery and TAVI data were pooled, the hazard ratios corresponded with about a doubling of risk for major adverse outcomes, including all-cause mortality (HR, 1.98; P < .001), cardiovascular mortality (HR, 1.82; P = .008), and hospitalization for aortic valve disease or worsening heart failure (HR, 2.11; P = .01). The relative risks were similar in the two treatment groups, including the risk of all-cause mortality (HR, 2.24; P < .001 for TAVI vs. HR, 2.45; P = .002 for SAVR).

The predictors for SVD on multivariate analysis included female sex, increased body surface area, prior percutaneous coronary intervention, and a prior diagnosis of atrial fibrillation.

Design improvements in TAVI devices are likely to explain these results, said Dr. Reardon, chair of cardiovascular research at Houston Methodist Hospital.

“The CoreValve/Evolut supra-annular, self-expanding bioprosthesis is the first and only transcatheter bioprosthesis to demonstrate lower rates of SVD, compared with surgery,” Dr. Reardon said.

This analysis validated the risks posed by the definition of SVD applied in this study, which appears to be a practical tool for tracking valve function and patient risk. Dr. Reardon also said that the study confirms the value of serial Doppler transthoracic echocardiography as a tool for monitoring SVD.

Several experts agreed that this is important new information.

“This is a remarkable series of findings,” said James McClurken, MD, who is a cardiovascular surgeon affiliated with Temple University, Philadelphia, and practices in Doylestown, Penn. By both demonstrating the prognostic importance of SVD and showing differences between the study device and SAVR, this trial will yield practical data to inform patients about relative risks and benefits.

Athena Poppas, MD, the new president of the ACC and a professor of medicine at Brown University, Providence, R.I., called this study “practice changing” for the same reasons. She also thinks it has valuable data for guiding choice of intervention.

Overall, the data are likely to change thinking about the role of TAVI and surgery in younger, fit patients, according to Megan Coylewright, MD, chief of cardiology at Erlanger Cardiology, Chattanooga, Tenn.

“There are patients [in need of aortic valve repair] with a long life expectancy who have been told you have to have a surgical repair because we know they last longer,” she said. Although she said that relative outcomes after longer follow-up remain unknown, “I think this does throw that comment into question.”

Dr. Reardon has financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical. Dr. Poppas and McClurken reported no potential financial conflicts of interest. Dr. Coylewright reported financial relationships with Abbott, Alleviant, Boston Scientific, Cardiosmart, Edwards Lifesciences, Medtronic, and Occlutech. The study received financial support from Medtronic.

Structural aortic valve deterioration (SVD) at 5 years is lower following repair with a contemporary transcatheter implantation (TAVI) device than with surgery, according to a pooled analysis of major trials.

For healthier patients with a relatively long life expectancy, this is important information for deciding whether to undergo TAVI or surgical aortic valve repair (SAVR), Michael J. Reardon, MD, said at the annual scientific sessions of the American College of Cardiology.

“Every week I get this question about which repair is more durable,” said Dr. Reardon, whose study was not only designed to compare device deterioration but to evaluate the effect of SVD on major outcomes.

In this analysis, the rates of SVD were compared for the self-expanding supra-annular CoreValve Evolut device and SAVR. The SVD curves separated within the first year. At 5 years, the differences were highly significant favoring TAVI (2.57% vs. 4.38%; P = .0095).

As part of this analysis, the impact of SVD was also assessed independent of type of repair. At 5 years, those with SVD relative to those without had an approximately twofold increase in all-cause mortality, cardiovascular mortality, and hospitalization of aortic valve worsening. These risks were elevated regardless of type of valve repair.

The data presented by Dr. Reardon can be considered device specific. The earlier PARTNER 2A study comparing older- and newer-generation TAVI devices with SAVR produced a different result. When a second-generation balloon-expandable SAPIEN XT device and a third-generation SAPIEN 3 device were compared with surgery, neither device achieved lower SVD rates relative to SAVR.

In PARTNER 2A, the SVD rate for the older device was nearly three times greater than SAVR (1.61 vs. 0.58 per 100 patient-years). The numerically higher SVD rates for the newer device (0.68 vs. 0.58 per 100 patient-years) was not statistically different, but the TAVI device was not superior.

More than 4,000 patients evaluated at 5 years

In the analysis presented by Dr. Reardon, data were pooled from the randomized CoreValve U.S. High-Risk Pivotal Trial and the SURTAVI Intermediate Risk Trial. Together, these studies randomized 971 patients to surgery and 1,128 patients to TAVI. Data on an additional 2,663 patients treated with the Evolut valve in two registries were added to the randomized trial data, providing data on 4,762 total patients with 5-year follow-up.

SVD was defined by two criteria. The first was a mean gradient increase of at least 10 mm Hg plus a mean overall gradient of at least 20 mm Hg as measured with echocardiography and assessed, when possible, by an independent core laboratory. The second was new-onset or increased intraprosthetic aortic regurgitation of at least moderate severity.

When graphed over time, the SVD curves separated in favor of TAVI after about 6 months of follow-up. The shape of the curves also differed. Unlike the steady rise in SVD observed in the surgery group, the SVD rate in the TAVI group remained below 1% for almost 4 years before beginning to climb.

There was greater relative benefit for the TAVI device in patients with annular diameters of 23 mm or less. Unlike the rise in SVD rates that began about 6 months after SAVR, the SVD rates in the TAVI patients remained at 0% for more than 2 years. At 5 years, the differences remained significant favoring TAVI (1.39% vs. 5.86%; P = .049).

In those with larger annular diameters, there was still a consistently lower SVD rate over time for TAVI relative to SAVR, but the trend for an advantage at 5 years fell just short of significance (2.48% vs. 3.96%; P = .067).
 

SVD linked to doubling of mortality

SVD worsened outcomes. When all data surgery and TAVI data were pooled, the hazard ratios corresponded with about a doubling of risk for major adverse outcomes, including all-cause mortality (HR, 1.98; P < .001), cardiovascular mortality (HR, 1.82; P = .008), and hospitalization for aortic valve disease or worsening heart failure (HR, 2.11; P = .01). The relative risks were similar in the two treatment groups, including the risk of all-cause mortality (HR, 2.24; P < .001 for TAVI vs. HR, 2.45; P = .002 for SAVR).

The predictors for SVD on multivariate analysis included female sex, increased body surface area, prior percutaneous coronary intervention, and a prior diagnosis of atrial fibrillation.

Design improvements in TAVI devices are likely to explain these results, said Dr. Reardon, chair of cardiovascular research at Houston Methodist Hospital.

“The CoreValve/Evolut supra-annular, self-expanding bioprosthesis is the first and only transcatheter bioprosthesis to demonstrate lower rates of SVD, compared with surgery,” Dr. Reardon said.

This analysis validated the risks posed by the definition of SVD applied in this study, which appears to be a practical tool for tracking valve function and patient risk. Dr. Reardon also said that the study confirms the value of serial Doppler transthoracic echocardiography as a tool for monitoring SVD.

Several experts agreed that this is important new information.

“This is a remarkable series of findings,” said James McClurken, MD, who is a cardiovascular surgeon affiliated with Temple University, Philadelphia, and practices in Doylestown, Penn. By both demonstrating the prognostic importance of SVD and showing differences between the study device and SAVR, this trial will yield practical data to inform patients about relative risks and benefits.

Athena Poppas, MD, the new president of the ACC and a professor of medicine at Brown University, Providence, R.I., called this study “practice changing” for the same reasons. She also thinks it has valuable data for guiding choice of intervention.

Overall, the data are likely to change thinking about the role of TAVI and surgery in younger, fit patients, according to Megan Coylewright, MD, chief of cardiology at Erlanger Cardiology, Chattanooga, Tenn.

“There are patients [in need of aortic valve repair] with a long life expectancy who have been told you have to have a surgical repair because we know they last longer,” she said. Although she said that relative outcomes after longer follow-up remain unknown, “I think this does throw that comment into question.”

Dr. Reardon has financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical. Dr. Poppas and McClurken reported no potential financial conflicts of interest. Dr. Coylewright reported financial relationships with Abbott, Alleviant, Boston Scientific, Cardiosmart, Edwards Lifesciences, Medtronic, and Occlutech. The study received financial support from Medtronic.

Structural aortic valve deterioration (SVD) at 5 years is lower following repair with a contemporary transcatheter implantation (TAVI) device than with surgery, according to a pooled analysis of major trials.

For healthier patients with a relatively long life expectancy, this is important information for deciding whether to undergo TAVI or surgical aortic valve repair (SAVR), Michael J. Reardon, MD, said at the annual scientific sessions of the American College of Cardiology.

“Every week I get this question about which repair is more durable,” said Dr. Reardon, whose study was not only designed to compare device deterioration but to evaluate the effect of SVD on major outcomes.

In this analysis, the rates of SVD were compared for the self-expanding supra-annular CoreValve Evolut device and SAVR. The SVD curves separated within the first year. At 5 years, the differences were highly significant favoring TAVI (2.57% vs. 4.38%; P = .0095).

As part of this analysis, the impact of SVD was also assessed independent of type of repair. At 5 years, those with SVD relative to those without had an approximately twofold increase in all-cause mortality, cardiovascular mortality, and hospitalization of aortic valve worsening. These risks were elevated regardless of type of valve repair.

The data presented by Dr. Reardon can be considered device specific. The earlier PARTNER 2A study comparing older- and newer-generation TAVI devices with SAVR produced a different result. When a second-generation balloon-expandable SAPIEN XT device and a third-generation SAPIEN 3 device were compared with surgery, neither device achieved lower SVD rates relative to SAVR.

In PARTNER 2A, the SVD rate for the older device was nearly three times greater than SAVR (1.61 vs. 0.58 per 100 patient-years). The numerically higher SVD rates for the newer device (0.68 vs. 0.58 per 100 patient-years) was not statistically different, but the TAVI device was not superior.

More than 4,000 patients evaluated at 5 years

In the analysis presented by Dr. Reardon, data were pooled from the randomized CoreValve U.S. High-Risk Pivotal Trial and the SURTAVI Intermediate Risk Trial. Together, these studies randomized 971 patients to surgery and 1,128 patients to TAVI. Data on an additional 2,663 patients treated with the Evolut valve in two registries were added to the randomized trial data, providing data on 4,762 total patients with 5-year follow-up.

SVD was defined by two criteria. The first was a mean gradient increase of at least 10 mm Hg plus a mean overall gradient of at least 20 mm Hg as measured with echocardiography and assessed, when possible, by an independent core laboratory. The second was new-onset or increased intraprosthetic aortic regurgitation of at least moderate severity.

When graphed over time, the SVD curves separated in favor of TAVI after about 6 months of follow-up. The shape of the curves also differed. Unlike the steady rise in SVD observed in the surgery group, the SVD rate in the TAVI group remained below 1% for almost 4 years before beginning to climb.

There was greater relative benefit for the TAVI device in patients with annular diameters of 23 mm or less. Unlike the rise in SVD rates that began about 6 months after SAVR, the SVD rates in the TAVI patients remained at 0% for more than 2 years. At 5 years, the differences remained significant favoring TAVI (1.39% vs. 5.86%; P = .049).

In those with larger annular diameters, there was still a consistently lower SVD rate over time for TAVI relative to SAVR, but the trend for an advantage at 5 years fell just short of significance (2.48% vs. 3.96%; P = .067).
 

SVD linked to doubling of mortality

SVD worsened outcomes. When all data surgery and TAVI data were pooled, the hazard ratios corresponded with about a doubling of risk for major adverse outcomes, including all-cause mortality (HR, 1.98; P < .001), cardiovascular mortality (HR, 1.82; P = .008), and hospitalization for aortic valve disease or worsening heart failure (HR, 2.11; P = .01). The relative risks were similar in the two treatment groups, including the risk of all-cause mortality (HR, 2.24; P < .001 for TAVI vs. HR, 2.45; P = .002 for SAVR).

The predictors for SVD on multivariate analysis included female sex, increased body surface area, prior percutaneous coronary intervention, and a prior diagnosis of atrial fibrillation.

Design improvements in TAVI devices are likely to explain these results, said Dr. Reardon, chair of cardiovascular research at Houston Methodist Hospital.

“The CoreValve/Evolut supra-annular, self-expanding bioprosthesis is the first and only transcatheter bioprosthesis to demonstrate lower rates of SVD, compared with surgery,” Dr. Reardon said.

This analysis validated the risks posed by the definition of SVD applied in this study, which appears to be a practical tool for tracking valve function and patient risk. Dr. Reardon also said that the study confirms the value of serial Doppler transthoracic echocardiography as a tool for monitoring SVD.

Several experts agreed that this is important new information.

“This is a remarkable series of findings,” said James McClurken, MD, who is a cardiovascular surgeon affiliated with Temple University, Philadelphia, and practices in Doylestown, Penn. By both demonstrating the prognostic importance of SVD and showing differences between the study device and SAVR, this trial will yield practical data to inform patients about relative risks and benefits.

Athena Poppas, MD, the new president of the ACC and a professor of medicine at Brown University, Providence, R.I., called this study “practice changing” for the same reasons. She also thinks it has valuable data for guiding choice of intervention.

Overall, the data are likely to change thinking about the role of TAVI and surgery in younger, fit patients, according to Megan Coylewright, MD, chief of cardiology at Erlanger Cardiology, Chattanooga, Tenn.

“There are patients [in need of aortic valve repair] with a long life expectancy who have been told you have to have a surgical repair because we know they last longer,” she said. Although she said that relative outcomes after longer follow-up remain unknown, “I think this does throw that comment into question.”

Dr. Reardon has financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical. Dr. Poppas and McClurken reported no potential financial conflicts of interest. Dr. Coylewright reported financial relationships with Abbott, Alleviant, Boston Scientific, Cardiosmart, Edwards Lifesciences, Medtronic, and Occlutech. The study received financial support from Medtronic.

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

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

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

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

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

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

There is a variety of ways to support the many impactful new programs the CHEST Foundation will launch in 2022, but one of the most anticipated options is the annual Belmont Stakes Dinner and Auction on June 11 in New York City. This fun-filled evening will include a viewing of the 154th running of “The Championship Track,” a cocktail reception and plated dinner, a silent auction, a rooftop party, and much more.

This year, the dinner and auction will support the CHEST Foundation’s work in patient education and CHEST initiatives to improve patient care. Two areas of focus are disparities in care delivery and improving patients’ quality of life through partnerships designed to encourage earlier diagnosis and treatment.

With these goals in mind, new initiatives include an extension of the 2020 Foundation Listening Tour designed to help clinicians increase trust, equity, and access to health care for patients in traditionally marginalized communities.

In addition, CHEST is partnering with the Three Lakes Foundation on a program dedicated to shortening the time to diagnosis for pulmonary fibrosis (PF). This initiative will bring together pulmonologists and primary care physicians to develop a strategy for identifying PF more quickly, ensuring treatment can begin earlier in the disease trajectory. Early detection of PF is associated with better quality of life for patients, so improving clinicians’ understanding of the signs and symptoms of this rare disease and formulating better guidance for diagnosing it could result in drastic improvements for those living with PF.

To highlight the importance of these efforts, the evening also will include speeches from two patient advocates who have turned their own experiences with living with chronic lung disease into incredible action on behalf of patients.

To learn more about the CHEST Foundation’s initiatives in 2022 and how you can attend the Belmont Stakes Dinner and Auction to support these efforts, visit foundation.chestnet.org.

There is a variety of ways to support the many impactful new programs the CHEST Foundation will launch in 2022, but one of the most anticipated options is the annual Belmont Stakes Dinner and Auction on June 11 in New York City. This fun-filled evening will include a viewing of the 154th running of “The Championship Track,” a cocktail reception and plated dinner, a silent auction, a rooftop party, and much more.

This year, the dinner and auction will support the CHEST Foundation’s work in patient education and CHEST initiatives to improve patient care. Two areas of focus are disparities in care delivery and improving patients’ quality of life through partnerships designed to encourage earlier diagnosis and treatment.

With these goals in mind, new initiatives include an extension of the 2020 Foundation Listening Tour designed to help clinicians increase trust, equity, and access to health care for patients in traditionally marginalized communities.

In addition, CHEST is partnering with the Three Lakes Foundation on a program dedicated to shortening the time to diagnosis for pulmonary fibrosis (PF). This initiative will bring together pulmonologists and primary care physicians to develop a strategy for identifying PF more quickly, ensuring treatment can begin earlier in the disease trajectory. Early detection of PF is associated with better quality of life for patients, so improving clinicians’ understanding of the signs and symptoms of this rare disease and formulating better guidance for diagnosing it could result in drastic improvements for those living with PF.

To highlight the importance of these efforts, the evening also will include speeches from two patient advocates who have turned their own experiences with living with chronic lung disease into incredible action on behalf of patients.

To learn more about the CHEST Foundation’s initiatives in 2022 and how you can attend the Belmont Stakes Dinner and Auction to support these efforts, visit foundation.chestnet.org.

There is a variety of ways to support the many impactful new programs the CHEST Foundation will launch in 2022, but one of the most anticipated options is the annual Belmont Stakes Dinner and Auction on June 11 in New York City. This fun-filled evening will include a viewing of the 154th running of “The Championship Track,” a cocktail reception and plated dinner, a silent auction, a rooftop party, and much more.

This year, the dinner and auction will support the CHEST Foundation’s work in patient education and CHEST initiatives to improve patient care. Two areas of focus are disparities in care delivery and improving patients’ quality of life through partnerships designed to encourage earlier diagnosis and treatment.

With these goals in mind, new initiatives include an extension of the 2020 Foundation Listening Tour designed to help clinicians increase trust, equity, and access to health care for patients in traditionally marginalized communities.

In addition, CHEST is partnering with the Three Lakes Foundation on a program dedicated to shortening the time to diagnosis for pulmonary fibrosis (PF). This initiative will bring together pulmonologists and primary care physicians to develop a strategy for identifying PF more quickly, ensuring treatment can begin earlier in the disease trajectory. Early detection of PF is associated with better quality of life for patients, so improving clinicians’ understanding of the signs and symptoms of this rare disease and formulating better guidance for diagnosing it could result in drastic improvements for those living with PF.

To highlight the importance of these efforts, the evening also will include speeches from two patient advocates who have turned their own experiences with living with chronic lung disease into incredible action on behalf of patients.

To learn more about the CHEST Foundation’s initiatives in 2022 and how you can attend the Belmont Stakes Dinner and Auction to support these efforts, visit foundation.chestnet.org.

In 2014, the Task Force for Mass Critical Care (TFMCC) published a CHEST consensus statement on disaster preparedness principles in caring for the critically ill during disasters and pandemics (Christian et al. CHEST. 2014;146[4_suppl]:8s-34s). This publication attempted to guide preparedness for both single-event disasters and more prolonged events, including a feared influenza pandemic.

Despite the foundation of planning and support this guidance provided, the COVID-19 pandemic response revealed substantial gaps in our understanding and preparedness for these more prolonged and widespread events.

In New York City, as the first COVID-19 wave began in March and April of 2020, area hospitals responded with surge plans that prioritized what was felt to be most important (Griffin et al. Am J Respir Crit Care Med. 2020 Jun 1;201[11]:1337-44). Tiered, creative staffing structures were rapidly created with intensivists supervising non-ICU physicians and APPs. Procedure teams were created for intubation, proning, and central line placement. ICU space was created with adaptations to ORs and PACUs, and rooms on med-surg floors and step-down units underwent emergency renovations to allow creation of new “pop-up” ICUs. Triage protocols were altered: patients on high levels of supplemental oxygen, who would under normal circumstances have been admitted to an ICU, were triaged to floors and stepdown units. Equipment was reused, modified, and substituted creatively to optimize care for the maximum number of patients.

In the face of all of these struggles, many around the country and the world felt the efforts, though heroic, resulted in less than standard of care. Two subsequent publications validated this concern (Kadri et al. Ann Int Med. 2021,174;9:1240-51; Bravata DM et al. JAMA Open Network. 2021;4[1]:e2034266), demonstrating during severe surge, COVID-19 patients’ mortality increased significantly beyond that seen in non-surging or less-severe surging times, demonstrating a mortality effect of surge itself. Though these studies observed COVID-19 patients only, there is every reason to believe the findings applied to all critically ill patients cared for during these surges.

These experiences led the TFMCC to report updated strategies for remaining in contingency care levels and avoiding crisis care (Dichter JR et al. CHEST. 2022;161[2]:429-47). Contingency is equivalent to routine care though may require adaptations and employment of otherwise non-traditional resources. The ultimate goal of mass critical care in a public health emergency is to avoid crisis-operating conditions, crisis standards of care, and their associated challenging triage decisions regarding allocation of scarce resources.

The 10 suggestions included in the most recent TFMCC publication include staffing strategies and suggestions based on COVID-19 experiences for graded staff-to-patient ratios, and support processes to preserve the existing health care work force. Strategies also include reduction of redundant documentation, limiting overtime, and most importantly, approaches for improving teamwork and supporting psychological well-being and resilience. Examples include daily unit huddles to update care and share experiences, genuine intra-team recognition and appreciation, and embedding emotional health experts within teams to provide ongoing support.

Consistent communication between incident command and frontline clinicians was also a suggested priority, perhaps with a newly proposed position of physician clinical support supervisor. This would be a formal role within hospital incident command, a liaison between the two groups.

Surge strategies should include empowerment of bedside clinicians and leaders with both planning and real-time assessment of the clinical situation, as being at the front line of care enables the situational awareness to assess ICU strain most effectively. Further, ICU clinicians must recognize when progression deeper into contingency operations occurs and they become perilously close to crisis mode. At this point, decisions are made and scarce resources are modified beyond routine standards of care to preserve life. TFMCC designates this gray area between contingency and crisis as the Critical Clinical Prioritization level (Figure).

Courtesy ACCP

At this point, more resources must be provided, or patients must be transferred to other resourced hospitals.

Critical Clinical Prioritization is an illustration of necessity being the mother of invention, as these are adaptations clinicians devised under duress. Some particularly poignant examples are the spreading of 24 hours of continuous renal replacement therapy (CRRT) resource between two and sometimes three patients to provide life sustainment to all; and when ventilators were in short supply, determining which patients required full ICU ventilator support vs those who could manage with lower functioning ventilators, and trading them between patients when demands changed.

These adaptations can only be done by experienced clinicians proactively managing bedside critical care under duress, further underscoring the importance of our suggestion that Critical Clinical Prioritization and ICU strain be managed by bedside clinicians and leaders.

The response of early transfer of patients – load-balancing - should be considered as soon as any hospital enters contingency conditions. This strategy is commonly implemented within larger health systems, ideally before reaching Critical Clinical Prioritization. Formal, organized state or regional load-balancing coordination, now referred to as medical operations command centers (MOCCs), were highly effective and proved lifesaving for those states that implemented them (including Arizona, Washington, California, Minnesota, and others). Support for establishment of MOCC’s is crucial in prolonging contingency operations and further helps support and protect disadvantaged populations (White et al. N Engl J Med. 2021;385[24]:2211-4).

Establishment of MOCCs has met resistance due to challenges that include interhospital/intersystem competition, logistics of moving critically ill patients sometimes across significant physical distance, and the costs of assuming care of uninsured or underinsured patients. Nevertheless, the benefits to the population as a whole necessitate working through these obstacles as successful MOCCs have done, usually with government and hospital association support.

In their final suggestion of the 2022 updated strategies, TFMCC suggests that hospitals use telemedicine technology both to expand specialists’ ability to provide care and facilitate families virtually visiting their critically ill loved one when safety precludes in-person visits.

These suggestions are pivotal in planning for future public health emergencies that include mass critical care, even during events that are limited in scope and duration.

Lastly, intensivists struggled with legal and ethical concerns when mired in crisis care circumstances and decisions of allocation, and potential reallocation, of scarce resources. These issues were not well addressed during the COVID-19 pandemic, further emphasizing the importance of maintaining contingency level care and requiring further involvement from legal and medical ethics professionals for future planning.

The guiding principle of disaster preparedness is that we must do all the planning we can to ensure that we never need crisis standards of care (National Academies of Sciences, Engineering, and Medicine. 2020 Mar 28. Rapid Expert Consultation on Crisis Standards of Care for the COVID-19 Pandemic. Washington, DC: The National Academies Press.).

We must be prepared. Guidelines and suggestions laid out through decades of experience gained a real-world test in the COVID-19 pandemic. Now we must all reorganize and create new plans or augment old ones with the information we have gained. The time is now. The work must continue.
 

Dr. Griffin is Assistant Professor of Medicine, New York Presbyterian Hospital – Weill Cornell Medicine. Dr. Dichter is Associate Professor of Medicine, University of Minnesota.

In 2014, the Task Force for Mass Critical Care (TFMCC) published a CHEST consensus statement on disaster preparedness principles in caring for the critically ill during disasters and pandemics (Christian et al. CHEST. 2014;146[4_suppl]:8s-34s). This publication attempted to guide preparedness for both single-event disasters and more prolonged events, including a feared influenza pandemic.

Despite the foundation of planning and support this guidance provided, the COVID-19 pandemic response revealed substantial gaps in our understanding and preparedness for these more prolonged and widespread events.

In New York City, as the first COVID-19 wave began in March and April of 2020, area hospitals responded with surge plans that prioritized what was felt to be most important (Griffin et al. Am J Respir Crit Care Med. 2020 Jun 1;201[11]:1337-44). Tiered, creative staffing structures were rapidly created with intensivists supervising non-ICU physicians and APPs. Procedure teams were created for intubation, proning, and central line placement. ICU space was created with adaptations to ORs and PACUs, and rooms on med-surg floors and step-down units underwent emergency renovations to allow creation of new “pop-up” ICUs. Triage protocols were altered: patients on high levels of supplemental oxygen, who would under normal circumstances have been admitted to an ICU, were triaged to floors and stepdown units. Equipment was reused, modified, and substituted creatively to optimize care for the maximum number of patients.

In the face of all of these struggles, many around the country and the world felt the efforts, though heroic, resulted in less than standard of care. Two subsequent publications validated this concern (Kadri et al. Ann Int Med. 2021,174;9:1240-51; Bravata DM et al. JAMA Open Network. 2021;4[1]:e2034266), demonstrating during severe surge, COVID-19 patients’ mortality increased significantly beyond that seen in non-surging or less-severe surging times, demonstrating a mortality effect of surge itself. Though these studies observed COVID-19 patients only, there is every reason to believe the findings applied to all critically ill patients cared for during these surges.

These experiences led the TFMCC to report updated strategies for remaining in contingency care levels and avoiding crisis care (Dichter JR et al. CHEST. 2022;161[2]:429-47). Contingency is equivalent to routine care though may require adaptations and employment of otherwise non-traditional resources. The ultimate goal of mass critical care in a public health emergency is to avoid crisis-operating conditions, crisis standards of care, and their associated challenging triage decisions regarding allocation of scarce resources.

The 10 suggestions included in the most recent TFMCC publication include staffing strategies and suggestions based on COVID-19 experiences for graded staff-to-patient ratios, and support processes to preserve the existing health care work force. Strategies also include reduction of redundant documentation, limiting overtime, and most importantly, approaches for improving teamwork and supporting psychological well-being and resilience. Examples include daily unit huddles to update care and share experiences, genuine intra-team recognition and appreciation, and embedding emotional health experts within teams to provide ongoing support.

Consistent communication between incident command and frontline clinicians was also a suggested priority, perhaps with a newly proposed position of physician clinical support supervisor. This would be a formal role within hospital incident command, a liaison between the two groups.

Surge strategies should include empowerment of bedside clinicians and leaders with both planning and real-time assessment of the clinical situation, as being at the front line of care enables the situational awareness to assess ICU strain most effectively. Further, ICU clinicians must recognize when progression deeper into contingency operations occurs and they become perilously close to crisis mode. At this point, decisions are made and scarce resources are modified beyond routine standards of care to preserve life. TFMCC designates this gray area between contingency and crisis as the Critical Clinical Prioritization level (Figure).

Courtesy ACCP

At this point, more resources must be provided, or patients must be transferred to other resourced hospitals.

Critical Clinical Prioritization is an illustration of necessity being the mother of invention, as these are adaptations clinicians devised under duress. Some particularly poignant examples are the spreading of 24 hours of continuous renal replacement therapy (CRRT) resource between two and sometimes three patients to provide life sustainment to all; and when ventilators were in short supply, determining which patients required full ICU ventilator support vs those who could manage with lower functioning ventilators, and trading them between patients when demands changed.

These adaptations can only be done by experienced clinicians proactively managing bedside critical care under duress, further underscoring the importance of our suggestion that Critical Clinical Prioritization and ICU strain be managed by bedside clinicians and leaders.

The response of early transfer of patients – load-balancing - should be considered as soon as any hospital enters contingency conditions. This strategy is commonly implemented within larger health systems, ideally before reaching Critical Clinical Prioritization. Formal, organized state or regional load-balancing coordination, now referred to as medical operations command centers (MOCCs), were highly effective and proved lifesaving for those states that implemented them (including Arizona, Washington, California, Minnesota, and others). Support for establishment of MOCC’s is crucial in prolonging contingency operations and further helps support and protect disadvantaged populations (White et al. N Engl J Med. 2021;385[24]:2211-4).

Establishment of MOCCs has met resistance due to challenges that include interhospital/intersystem competition, logistics of moving critically ill patients sometimes across significant physical distance, and the costs of assuming care of uninsured or underinsured patients. Nevertheless, the benefits to the population as a whole necessitate working through these obstacles as successful MOCCs have done, usually with government and hospital association support.

In their final suggestion of the 2022 updated strategies, TFMCC suggests that hospitals use telemedicine technology both to expand specialists’ ability to provide care and facilitate families virtually visiting their critically ill loved one when safety precludes in-person visits.

These suggestions are pivotal in planning for future public health emergencies that include mass critical care, even during events that are limited in scope and duration.

Lastly, intensivists struggled with legal and ethical concerns when mired in crisis care circumstances and decisions of allocation, and potential reallocation, of scarce resources. These issues were not well addressed during the COVID-19 pandemic, further emphasizing the importance of maintaining contingency level care and requiring further involvement from legal and medical ethics professionals for future planning.

The guiding principle of disaster preparedness is that we must do all the planning we can to ensure that we never need crisis standards of care (National Academies of Sciences, Engineering, and Medicine. 2020 Mar 28. Rapid Expert Consultation on Crisis Standards of Care for the COVID-19 Pandemic. Washington, DC: The National Academies Press.).

We must be prepared. Guidelines and suggestions laid out through decades of experience gained a real-world test in the COVID-19 pandemic. Now we must all reorganize and create new plans or augment old ones with the information we have gained. The time is now. The work must continue.
 

Dr. Griffin is Assistant Professor of Medicine, New York Presbyterian Hospital – Weill Cornell Medicine. Dr. Dichter is Associate Professor of Medicine, University of Minnesota.

In 2014, the Task Force for Mass Critical Care (TFMCC) published a CHEST consensus statement on disaster preparedness principles in caring for the critically ill during disasters and pandemics (Christian et al. CHEST. 2014;146[4_suppl]:8s-34s). This publication attempted to guide preparedness for both single-event disasters and more prolonged events, including a feared influenza pandemic.

Despite the foundation of planning and support this guidance provided, the COVID-19 pandemic response revealed substantial gaps in our understanding and preparedness for these more prolonged and widespread events.

In New York City, as the first COVID-19 wave began in March and April of 2020, area hospitals responded with surge plans that prioritized what was felt to be most important (Griffin et al. Am J Respir Crit Care Med. 2020 Jun 1;201[11]:1337-44). Tiered, creative staffing structures were rapidly created with intensivists supervising non-ICU physicians and APPs. Procedure teams were created for intubation, proning, and central line placement. ICU space was created with adaptations to ORs and PACUs, and rooms on med-surg floors and step-down units underwent emergency renovations to allow creation of new “pop-up” ICUs. Triage protocols were altered: patients on high levels of supplemental oxygen, who would under normal circumstances have been admitted to an ICU, were triaged to floors and stepdown units. Equipment was reused, modified, and substituted creatively to optimize care for the maximum number of patients.

In the face of all of these struggles, many around the country and the world felt the efforts, though heroic, resulted in less than standard of care. Two subsequent publications validated this concern (Kadri et al. Ann Int Med. 2021,174;9:1240-51; Bravata DM et al. JAMA Open Network. 2021;4[1]:e2034266), demonstrating during severe surge, COVID-19 patients’ mortality increased significantly beyond that seen in non-surging or less-severe surging times, demonstrating a mortality effect of surge itself. Though these studies observed COVID-19 patients only, there is every reason to believe the findings applied to all critically ill patients cared for during these surges.

These experiences led the TFMCC to report updated strategies for remaining in contingency care levels and avoiding crisis care (Dichter JR et al. CHEST. 2022;161[2]:429-47). Contingency is equivalent to routine care though may require adaptations and employment of otherwise non-traditional resources. The ultimate goal of mass critical care in a public health emergency is to avoid crisis-operating conditions, crisis standards of care, and their associated challenging triage decisions regarding allocation of scarce resources.

The 10 suggestions included in the most recent TFMCC publication include staffing strategies and suggestions based on COVID-19 experiences for graded staff-to-patient ratios, and support processes to preserve the existing health care work force. Strategies also include reduction of redundant documentation, limiting overtime, and most importantly, approaches for improving teamwork and supporting psychological well-being and resilience. Examples include daily unit huddles to update care and share experiences, genuine intra-team recognition and appreciation, and embedding emotional health experts within teams to provide ongoing support.

Consistent communication between incident command and frontline clinicians was also a suggested priority, perhaps with a newly proposed position of physician clinical support supervisor. This would be a formal role within hospital incident command, a liaison between the two groups.

Surge strategies should include empowerment of bedside clinicians and leaders with both planning and real-time assessment of the clinical situation, as being at the front line of care enables the situational awareness to assess ICU strain most effectively. Further, ICU clinicians must recognize when progression deeper into contingency operations occurs and they become perilously close to crisis mode. At this point, decisions are made and scarce resources are modified beyond routine standards of care to preserve life. TFMCC designates this gray area between contingency and crisis as the Critical Clinical Prioritization level (Figure).

Courtesy ACCP

At this point, more resources must be provided, or patients must be transferred to other resourced hospitals.

Critical Clinical Prioritization is an illustration of necessity being the mother of invention, as these are adaptations clinicians devised under duress. Some particularly poignant examples are the spreading of 24 hours of continuous renal replacement therapy (CRRT) resource between two and sometimes three patients to provide life sustainment to all; and when ventilators were in short supply, determining which patients required full ICU ventilator support vs those who could manage with lower functioning ventilators, and trading them between patients when demands changed.

These adaptations can only be done by experienced clinicians proactively managing bedside critical care under duress, further underscoring the importance of our suggestion that Critical Clinical Prioritization and ICU strain be managed by bedside clinicians and leaders.

The response of early transfer of patients – load-balancing - should be considered as soon as any hospital enters contingency conditions. This strategy is commonly implemented within larger health systems, ideally before reaching Critical Clinical Prioritization. Formal, organized state or regional load-balancing coordination, now referred to as medical operations command centers (MOCCs), were highly effective and proved lifesaving for those states that implemented them (including Arizona, Washington, California, Minnesota, and others). Support for establishment of MOCC’s is crucial in prolonging contingency operations and further helps support and protect disadvantaged populations (White et al. N Engl J Med. 2021;385[24]:2211-4).

Establishment of MOCCs has met resistance due to challenges that include interhospital/intersystem competition, logistics of moving critically ill patients sometimes across significant physical distance, and the costs of assuming care of uninsured or underinsured patients. Nevertheless, the benefits to the population as a whole necessitate working through these obstacles as successful MOCCs have done, usually with government and hospital association support.

In their final suggestion of the 2022 updated strategies, TFMCC suggests that hospitals use telemedicine technology both to expand specialists’ ability to provide care and facilitate families virtually visiting their critically ill loved one when safety precludes in-person visits.

These suggestions are pivotal in planning for future public health emergencies that include mass critical care, even during events that are limited in scope and duration.

Lastly, intensivists struggled with legal and ethical concerns when mired in crisis care circumstances and decisions of allocation, and potential reallocation, of scarce resources. These issues were not well addressed during the COVID-19 pandemic, further emphasizing the importance of maintaining contingency level care and requiring further involvement from legal and medical ethics professionals for future planning.

The guiding principle of disaster preparedness is that we must do all the planning we can to ensure that we never need crisis standards of care (National Academies of Sciences, Engineering, and Medicine. 2020 Mar 28. Rapid Expert Consultation on Crisis Standards of Care for the COVID-19 Pandemic. Washington, DC: The National Academies Press.).

We must be prepared. Guidelines and suggestions laid out through decades of experience gained a real-world test in the COVID-19 pandemic. Now we must all reorganize and create new plans or augment old ones with the information we have gained. The time is now. The work must continue.
 

Dr. Griffin is Assistant Professor of Medicine, New York Presbyterian Hospital – Weill Cornell Medicine. Dr. Dichter is Associate Professor of Medicine, University of Minnesota.

A quality educational meeting starts with a great slate of programs tailored to its audience, and CHEST 2022 is on-track to offer the highest tier of education for those in pulmonary, critical care, and sleep medicine.

Although planning for the meeting started after CHEST 2021 wrapped up, the real magic started to happen a few months ago when the schedule began coming together. In mid-February, members of the Scientific Planning Committee gathered both virtually and in-person at the CHEST headquarters to solidify the schedule for the upcoming CHEST 2022 meeting taking place in Nashville, TN, October 16-19.

The excitement in the room was palpable as committee members gathered for the first time in over a year to plan what will be the first in-person meeting since CHEST 2019 in New Orleans.

Chair of CHEST 2022, Subani Chandra, MD, FCCP, has high expectations for the meeting and is excited for everyone to be together in Nashville. “There is something special about an in-person meeting and my goal for CHEST 2022 is to not only meet the academic needs of the attendees, but also to serve as a chance to recharge after a long haul in managing COVID-19,” says Dr. Chandra. “Many first-time CHEST attendees are fellows and, with the last two meetings being virtual, there are a lot of fellows who have yet to attend a meeting in-person, so that is a big responsibility for us and opportunity for them. We want to make sure they have a fun and productive meeting – learn from the best, understand how to apply the latest research, get to present their work, network, participate, and have fun doing it all!”

With something for everyone in chest medicine, the CHEST 2022 meeting will feature over 200 sessions covering eight curriculum groups:

• Obstructive lung disease
• Sleep
• Chest infections
• Cardiovascular/pulmonary vascular disease
• Pulmonary procedures/lung cancer/cardiothoracic surgery
• Interstitial lung disease/radiology
• Interdisciplinary/practice operations/education
• Critical care

Covering a large breadth of information, the sessions will include the latest trends in COVID-19 care – recommended protocols, surge-planning and best practices; deeper looks into the latest CHEST guidelines – thromboprophylaxis in patients with COVID-19, antithrombotic therapy for VTE disease, and the guidelines for lung cancer screening; and sessions speaking to diversity, inclusion, and equity within medicine, including how lung disease affects populations differently.

Dr. Chandra says diversity was top of mind throughout the planning process. When submitting session ideas, it was noted that “submissions with speakers representing one gender and/or one institution will not be considered,” and that “selection priority will be given to outstanding submissions with proposed speakers who represent diversity of race, ethnicity, and professional status.”

During February’s meeting, as the committee members confirmed each of the sessions, they took the time to ensure every single one had presenters from a variety of backgrounds, including diversity of gender, race, credentialing, and years of experience in medicine.

It was important to the committee that this not be a physician-only meeting, because both CHEST and Pulmonary/Critical Care Medicine feature an array of team members including physicians, advance practice providers, respiratory therapists, nurses and other members of the care team and the sessions will reflect that.

When asked what she hopes attendees will gain from CHEST 2022, Dr. Chandra says, “I want attendees to feel the joy that comes from not only being together, but learning together.”

She continued, “I want this meeting to remind clinicians why they fell in love with medicine and to remember why it is that we do what we do, especially after two grueling years. Attendees should leave feeling reinvigorated and charged with the latest literature and clinical expertise ready to be implemented into practice. Most of all, I want all of the attendees to have fun, because we are there to learn, but CHEST is also about enjoying medicine and those around you. I just cannot wait.”

A quality educational meeting starts with a great slate of programs tailored to its audience, and CHEST 2022 is on-track to offer the highest tier of education for those in pulmonary, critical care, and sleep medicine.

Although planning for the meeting started after CHEST 2021 wrapped up, the real magic started to happen a few months ago when the schedule began coming together. In mid-February, members of the Scientific Planning Committee gathered both virtually and in-person at the CHEST headquarters to solidify the schedule for the upcoming CHEST 2022 meeting taking place in Nashville, TN, October 16-19.

The excitement in the room was palpable as committee members gathered for the first time in over a year to plan what will be the first in-person meeting since CHEST 2019 in New Orleans.

Chair of CHEST 2022, Subani Chandra, MD, FCCP, has high expectations for the meeting and is excited for everyone to be together in Nashville. “There is something special about an in-person meeting and my goal for CHEST 2022 is to not only meet the academic needs of the attendees, but also to serve as a chance to recharge after a long haul in managing COVID-19,” says Dr. Chandra. “Many first-time CHEST attendees are fellows and, with the last two meetings being virtual, there are a lot of fellows who have yet to attend a meeting in-person, so that is a big responsibility for us and opportunity for them. We want to make sure they have a fun and productive meeting – learn from the best, understand how to apply the latest research, get to present their work, network, participate, and have fun doing it all!”

With something for everyone in chest medicine, the CHEST 2022 meeting will feature over 200 sessions covering eight curriculum groups:

• Obstructive lung disease
• Sleep
• Chest infections
• Cardiovascular/pulmonary vascular disease
• Pulmonary procedures/lung cancer/cardiothoracic surgery
• Interstitial lung disease/radiology
• Interdisciplinary/practice operations/education
• Critical care

Covering a large breadth of information, the sessions will include the latest trends in COVID-19 care – recommended protocols, surge-planning and best practices; deeper looks into the latest CHEST guidelines – thromboprophylaxis in patients with COVID-19, antithrombotic therapy for VTE disease, and the guidelines for lung cancer screening; and sessions speaking to diversity, inclusion, and equity within medicine, including how lung disease affects populations differently.

Dr. Chandra says diversity was top of mind throughout the planning process. When submitting session ideas, it was noted that “submissions with speakers representing one gender and/or one institution will not be considered,” and that “selection priority will be given to outstanding submissions with proposed speakers who represent diversity of race, ethnicity, and professional status.”

During February’s meeting, as the committee members confirmed each of the sessions, they took the time to ensure every single one had presenters from a variety of backgrounds, including diversity of gender, race, credentialing, and years of experience in medicine.

It was important to the committee that this not be a physician-only meeting, because both CHEST and Pulmonary/Critical Care Medicine feature an array of team members including physicians, advance practice providers, respiratory therapists, nurses and other members of the care team and the sessions will reflect that.

When asked what she hopes attendees will gain from CHEST 2022, Dr. Chandra says, “I want attendees to feel the joy that comes from not only being together, but learning together.”

She continued, “I want this meeting to remind clinicians why they fell in love with medicine and to remember why it is that we do what we do, especially after two grueling years. Attendees should leave feeling reinvigorated and charged with the latest literature and clinical expertise ready to be implemented into practice. Most of all, I want all of the attendees to have fun, because we are there to learn, but CHEST is also about enjoying medicine and those around you. I just cannot wait.”

A quality educational meeting starts with a great slate of programs tailored to its audience, and CHEST 2022 is on-track to offer the highest tier of education for those in pulmonary, critical care, and sleep medicine.

Although planning for the meeting started after CHEST 2021 wrapped up, the real magic started to happen a few months ago when the schedule began coming together. In mid-February, members of the Scientific Planning Committee gathered both virtually and in-person at the CHEST headquarters to solidify the schedule for the upcoming CHEST 2022 meeting taking place in Nashville, TN, October 16-19.

The excitement in the room was palpable as committee members gathered for the first time in over a year to plan what will be the first in-person meeting since CHEST 2019 in New Orleans.

Chair of CHEST 2022, Subani Chandra, MD, FCCP, has high expectations for the meeting and is excited for everyone to be together in Nashville. “There is something special about an in-person meeting and my goal for CHEST 2022 is to not only meet the academic needs of the attendees, but also to serve as a chance to recharge after a long haul in managing COVID-19,” says Dr. Chandra. “Many first-time CHEST attendees are fellows and, with the last two meetings being virtual, there are a lot of fellows who have yet to attend a meeting in-person, so that is a big responsibility for us and opportunity for them. We want to make sure they have a fun and productive meeting – learn from the best, understand how to apply the latest research, get to present their work, network, participate, and have fun doing it all!”

With something for everyone in chest medicine, the CHEST 2022 meeting will feature over 200 sessions covering eight curriculum groups:

• Obstructive lung disease
• Sleep
• Chest infections
• Cardiovascular/pulmonary vascular disease
• Pulmonary procedures/lung cancer/cardiothoracic surgery
• Interstitial lung disease/radiology
• Interdisciplinary/practice operations/education
• Critical care

Covering a large breadth of information, the sessions will include the latest trends in COVID-19 care – recommended protocols, surge-planning and best practices; deeper looks into the latest CHEST guidelines – thromboprophylaxis in patients with COVID-19, antithrombotic therapy for VTE disease, and the guidelines for lung cancer screening; and sessions speaking to diversity, inclusion, and equity within medicine, including how lung disease affects populations differently.

Dr. Chandra says diversity was top of mind throughout the planning process. When submitting session ideas, it was noted that “submissions with speakers representing one gender and/or one institution will not be considered,” and that “selection priority will be given to outstanding submissions with proposed speakers who represent diversity of race, ethnicity, and professional status.”

During February’s meeting, as the committee members confirmed each of the sessions, they took the time to ensure every single one had presenters from a variety of backgrounds, including diversity of gender, race, credentialing, and years of experience in medicine.

It was important to the committee that this not be a physician-only meeting, because both CHEST and Pulmonary/Critical Care Medicine feature an array of team members including physicians, advance practice providers, respiratory therapists, nurses and other members of the care team and the sessions will reflect that.

When asked what she hopes attendees will gain from CHEST 2022, Dr. Chandra says, “I want attendees to feel the joy that comes from not only being together, but learning together.”

She continued, “I want this meeting to remind clinicians why they fell in love with medicine and to remember why it is that we do what we do, especially after two grueling years. Attendees should leave feeling reinvigorated and charged with the latest literature and clinical expertise ready to be implemented into practice. Most of all, I want all of the attendees to have fun, because we are there to learn, but CHEST is also about enjoying medicine and those around you. I just cannot wait.”