Internal Medicine News

PHILADELPHIA — A new 10-day treatment regimen with the oral potassium-competitive acid blocker vonoprazan, and the antibiotics levofloxacin and amoxicillin, was significantly more effective at eradicating Helicobacter pylori infection than triple therapy with omeprazole, amoxicillin, and clarithromycin, according to the results of a randomized, multicenter study.

In addition, the triple therapy regimen with vonoprazan was generally better tolerated than the 14-day omeprazole-based regimen.

The new treatment combination was created to tackle the two main reasons that patients with H pylori experience treatment failure: Inadequate acid suppressant activity and antibiotic resistance, said principal investigator Kachonsak Yongwatana, MD, from Phramongkutklao Hospital in Bangkok, Thailand.

“Vonoprazan” is the more potent option for acid suppression, and “levofloxacin” addresses antibiotic resistance, he explained.

Yongwatana presented the findings (Abstract 41) at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. The ACG recently released a clinical guideline on the treatment of H pylori infection. 
 

Robust Eradication Rates

Yongwatana and colleagues enrolled adult patients with H pylori infections at four hospitals in Thailand between December 2022 and September 2023. The presence of H pylori was confirmed by upper gastrointestinal endoscopy with positive rapid urease test or positive test on tissue biopsy. 

Patients were then randomized into two treatment groups: The 10-day VAL group (vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and levofloxacin 500 mg once daily for 10 days) and the 14-day OAC group (omeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily for 14 days). Eradication was assessed by urea breath test 4 weeks after completion of treatment.

There were 280 patients in total, with 140 in each group. There were no significant differences in baseline characteristics between the groups. The most common endoscopic findings among all participants included erosive gastritis (38%), nonerosive gastritis (27%), and gastric ulcer (17%). 

In comparing the treatments, the researchers found that 10-day VAL led to significantly greater H pylori eradication rate than the 14-day OAC group in both intention-to-treat analysis (91.4 % vs 80.7%, P = .009) and per-protocol analysis (93.4% vs 83.7%, P = .012). 

Vonoprazan-based therapy was also well tolerated by participants. Patients in the 10-day VAL group had significantly lower rates of experiencing a bitter taste (2.1% vs 42.9%, P < .001) and bloating (5% vs 12.1%, P = .033) than those in the 14-day OAC group. 
 

Isolating the BMI Effect

The researchers conducted a subgroup analysis on potential factors influencing response, which revealed that having a body mass index (BMI) < 23.5 was significantly associated with a higher chance at successful H pylori eradication (relative risk [RR], 2.27; P = .049). 

They then analyzed whether this BMI threshold was predictive in the separate treatment regimens. Although having a BMI < 23.5 was significantly associated with a higher eradication rate in the 14-day OAC group (RR, 3.34; P = .026), no such effect was noted in the 10-day VAL group (RR, 1.10; P = .888).

The influence of BMI could be caused by the bioavailability of the treatments used in the regimen, Younwatana said in an interview. He and his colleagues recommended against using the 14-day OAC regimen in those with BMI ≥ 23.5.

“In patients with a high BMI, we should be concerned that normal proton pump inhibitors may not work,” he said. “You have to step up to the higher-potency options.” 
 

Seeking Confirmation in Other Populations

Session comoderator Felice Schnoll-Sussman, MD, MSc, professor of clinical medicine and the director of the Jay Monahan Center for Gastrointestinal Health, director of the DIGEST program, and the associate chair of medicine for Outreach and Network at New York–Presbyterian Brooklyn Methodist Hospital in New York City, said in an interview that the promising results merit confirmation in other populations. 

“When you see a study that is coming out of one country, when there could be issues related to antibiotic sensitivity in H pylori, it really is important to decide whether or not this is applicable to other patient populations,” said Schnoll-Sussman, who was not involved in the study. 

She noted that this is also true of the findings from the subgroup as it is unclear whether average rates of BMI are notably lower in Thailand from other countries.

“As we know, BMI affects so many things with disease states. So, it’s a possibility in a country where the BMI is actually lower, there may be something else about these individuals in terms of their wellness status that could be underlying the effect.” 

The study had no specific funding, although Takeda supplied treatments used in the analysis. Yongwatana reported no relevant financial relationships. Schnoll-Sussman reported serving as an advisory committee/board member for Braintree, Ethicon, Implantica, and Phathom. 

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

PHILADELPHIA — A new 10-day treatment regimen with the oral potassium-competitive acid blocker vonoprazan, and the antibiotics levofloxacin and amoxicillin, was significantly more effective at eradicating Helicobacter pylori infection than triple therapy with omeprazole, amoxicillin, and clarithromycin, according to the results of a randomized, multicenter study.

In addition, the triple therapy regimen with vonoprazan was generally better tolerated than the 14-day omeprazole-based regimen.

The new treatment combination was created to tackle the two main reasons that patients with H pylori experience treatment failure: Inadequate acid suppressant activity and antibiotic resistance, said principal investigator Kachonsak Yongwatana, MD, from Phramongkutklao Hospital in Bangkok, Thailand.

“Vonoprazan” is the more potent option for acid suppression, and “levofloxacin” addresses antibiotic resistance, he explained.

Yongwatana presented the findings (Abstract 41) at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. The ACG recently released a clinical guideline on the treatment of H pylori infection. 
 

Robust Eradication Rates

Yongwatana and colleagues enrolled adult patients with H pylori infections at four hospitals in Thailand between December 2022 and September 2023. The presence of H pylori was confirmed by upper gastrointestinal endoscopy with positive rapid urease test or positive test on tissue biopsy. 

Patients were then randomized into two treatment groups: The 10-day VAL group (vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and levofloxacin 500 mg once daily for 10 days) and the 14-day OAC group (omeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily for 14 days). Eradication was assessed by urea breath test 4 weeks after completion of treatment.

There were 280 patients in total, with 140 in each group. There were no significant differences in baseline characteristics between the groups. The most common endoscopic findings among all participants included erosive gastritis (38%), nonerosive gastritis (27%), and gastric ulcer (17%). 

In comparing the treatments, the researchers found that 10-day VAL led to significantly greater H pylori eradication rate than the 14-day OAC group in both intention-to-treat analysis (91.4 % vs 80.7%, P = .009) and per-protocol analysis (93.4% vs 83.7%, P = .012). 

Vonoprazan-based therapy was also well tolerated by participants. Patients in the 10-day VAL group had significantly lower rates of experiencing a bitter taste (2.1% vs 42.9%, P < .001) and bloating (5% vs 12.1%, P = .033) than those in the 14-day OAC group. 
 

Isolating the BMI Effect

The researchers conducted a subgroup analysis on potential factors influencing response, which revealed that having a body mass index (BMI) < 23.5 was significantly associated with a higher chance at successful H pylori eradication (relative risk [RR], 2.27; P = .049). 

They then analyzed whether this BMI threshold was predictive in the separate treatment regimens. Although having a BMI < 23.5 was significantly associated with a higher eradication rate in the 14-day OAC group (RR, 3.34; P = .026), no such effect was noted in the 10-day VAL group (RR, 1.10; P = .888).

The influence of BMI could be caused by the bioavailability of the treatments used in the regimen, Younwatana said in an interview. He and his colleagues recommended against using the 14-day OAC regimen in those with BMI ≥ 23.5.

“In patients with a high BMI, we should be concerned that normal proton pump inhibitors may not work,” he said. “You have to step up to the higher-potency options.” 
 

Seeking Confirmation in Other Populations

Session comoderator Felice Schnoll-Sussman, MD, MSc, professor of clinical medicine and the director of the Jay Monahan Center for Gastrointestinal Health, director of the DIGEST program, and the associate chair of medicine for Outreach and Network at New York–Presbyterian Brooklyn Methodist Hospital in New York City, said in an interview that the promising results merit confirmation in other populations. 

“When you see a study that is coming out of one country, when there could be issues related to antibiotic sensitivity in H pylori, it really is important to decide whether or not this is applicable to other patient populations,” said Schnoll-Sussman, who was not involved in the study. 

She noted that this is also true of the findings from the subgroup as it is unclear whether average rates of BMI are notably lower in Thailand from other countries.

“As we know, BMI affects so many things with disease states. So, it’s a possibility in a country where the BMI is actually lower, there may be something else about these individuals in terms of their wellness status that could be underlying the effect.” 

The study had no specific funding, although Takeda supplied treatments used in the analysis. Yongwatana reported no relevant financial relationships. Schnoll-Sussman reported serving as an advisory committee/board member for Braintree, Ethicon, Implantica, and Phathom. 

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

PHILADELPHIA — A new 10-day treatment regimen with the oral potassium-competitive acid blocker vonoprazan, and the antibiotics levofloxacin and amoxicillin, was significantly more effective at eradicating Helicobacter pylori infection than triple therapy with omeprazole, amoxicillin, and clarithromycin, according to the results of a randomized, multicenter study.

In addition, the triple therapy regimen with vonoprazan was generally better tolerated than the 14-day omeprazole-based regimen.

The new treatment combination was created to tackle the two main reasons that patients with H pylori experience treatment failure: Inadequate acid suppressant activity and antibiotic resistance, said principal investigator Kachonsak Yongwatana, MD, from Phramongkutklao Hospital in Bangkok, Thailand.

“Vonoprazan” is the more potent option for acid suppression, and “levofloxacin” addresses antibiotic resistance, he explained.

Yongwatana presented the findings (Abstract 41) at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. The ACG recently released a clinical guideline on the treatment of H pylori infection. 
 

Robust Eradication Rates

Yongwatana and colleagues enrolled adult patients with H pylori infections at four hospitals in Thailand between December 2022 and September 2023. The presence of H pylori was confirmed by upper gastrointestinal endoscopy with positive rapid urease test or positive test on tissue biopsy. 

Patients were then randomized into two treatment groups: The 10-day VAL group (vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and levofloxacin 500 mg once daily for 10 days) and the 14-day OAC group (omeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily for 14 days). Eradication was assessed by urea breath test 4 weeks after completion of treatment.

There were 280 patients in total, with 140 in each group. There were no significant differences in baseline characteristics between the groups. The most common endoscopic findings among all participants included erosive gastritis (38%), nonerosive gastritis (27%), and gastric ulcer (17%). 

In comparing the treatments, the researchers found that 10-day VAL led to significantly greater H pylori eradication rate than the 14-day OAC group in both intention-to-treat analysis (91.4 % vs 80.7%, P = .009) and per-protocol analysis (93.4% vs 83.7%, P = .012). 

Vonoprazan-based therapy was also well tolerated by participants. Patients in the 10-day VAL group had significantly lower rates of experiencing a bitter taste (2.1% vs 42.9%, P < .001) and bloating (5% vs 12.1%, P = .033) than those in the 14-day OAC group. 
 

Isolating the BMI Effect

The researchers conducted a subgroup analysis on potential factors influencing response, which revealed that having a body mass index (BMI) < 23.5 was significantly associated with a higher chance at successful H pylori eradication (relative risk [RR], 2.27; P = .049). 

They then analyzed whether this BMI threshold was predictive in the separate treatment regimens. Although having a BMI < 23.5 was significantly associated with a higher eradication rate in the 14-day OAC group (RR, 3.34; P = .026), no such effect was noted in the 10-day VAL group (RR, 1.10; P = .888).

The influence of BMI could be caused by the bioavailability of the treatments used in the regimen, Younwatana said in an interview. He and his colleagues recommended against using the 14-day OAC regimen in those with BMI ≥ 23.5.

“In patients with a high BMI, we should be concerned that normal proton pump inhibitors may not work,” he said. “You have to step up to the higher-potency options.” 
 

Seeking Confirmation in Other Populations

Session comoderator Felice Schnoll-Sussman, MD, MSc, professor of clinical medicine and the director of the Jay Monahan Center for Gastrointestinal Health, director of the DIGEST program, and the associate chair of medicine for Outreach and Network at New York–Presbyterian Brooklyn Methodist Hospital in New York City, said in an interview that the promising results merit confirmation in other populations. 

“When you see a study that is coming out of one country, when there could be issues related to antibiotic sensitivity in H pylori, it really is important to decide whether or not this is applicable to other patient populations,” said Schnoll-Sussman, who was not involved in the study. 

She noted that this is also true of the findings from the subgroup as it is unclear whether average rates of BMI are notably lower in Thailand from other countries.

“As we know, BMI affects so many things with disease states. So, it’s a possibility in a country where the BMI is actually lower, there may be something else about these individuals in terms of their wellness status that could be underlying the effect.” 

The study had no specific funding, although Takeda supplied treatments used in the analysis. Yongwatana reported no relevant financial relationships. Schnoll-Sussman reported serving as an advisory committee/board member for Braintree, Ethicon, Implantica, and Phathom. 

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

TOPLINE:

There is no significant association between the use of proton pump inhibitors (PPIs) and risk for cardiovascular events, a meta-analysis shows. However, patients with gastroesophageal reflux disease (GERD) do experience a slight increase in cardiovascular events with PPI use.

METHODOLOGY:

• PPIs are commonly used gastric acid suppressants; however, they have pleiotropic effects, some of which have been hypothesized to augment cardiovascular disorders.
• Researchers conducted a meta-analysis of randomized clinical trials with at least 100 patients and treatment durations > 30 days, which compared groups receiving PPIs to those on placebo or other active treatments.
• The primary outcome was a composite of nonfatal myocardial infarctions, nonfatal strokes, fatal cardiovascular adverse events, coronary revascularizations, and hospitalizations for unstable angina.

TAKEAWAY:

• Researchers included data from 52 placebo-controlled trials, with 14,988 patients and 8323 patients randomized to receive a PPI or placebo, respectively; the mean treatment duration was 0.45 person-years for those treated with PPIs and 0.32 person-years for those treated with placebo.
• Among placebo-controlled trials, 24 were conducted in patients with GERD.
• Researchers also included 61 active-controlled trials that compared PPIs with histamine-2 receptor antagonists (51 trials) or other active treatments.
• The incidence rate ratio for the primary outcome was 0.72 when comparing PPI to placebo, indicating no significant association between PPI and cardiovascular events.
• Among patients with GERD, cardiovascular events occurred only in those treated with PPIs, leading to approximately one excess cardiovascular event per 100 person-years of PPI treatment relative to placebo.
• Researchers found no association between PPI treatment and the risk for cardiovascular events in trials comparing PPIs with other active treatments.

IN PRACTICE:

“We found no association of cardiovascular events with PPI treatment,” the authors wrote. “Cardiovascular events appeared more frequent with PPI treatment in GERD trials, but results from this subgroup should be interpreted with the limitations of the analysis in mind.”

SOURCE:

The study, led by Andrew D. Mosholder, MD, MPH, Division of Epidemiology, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, Maryland, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

This study lacked individual patient data, which precluded a time-to-event analysis or an analysis accounting for patient characteristics such as age or sex. The mean duration of PPI treatment in these trials was a few months, limiting the assessment of cardiovascular risk with extended use. The risk estimates were influenced the most by data on omeprazole and esomeprazole.

DISCLOSURES:

This study did not receive any funding. The authors declared no conflicts of interests.

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

TOPLINE:

There is no significant association between the use of proton pump inhibitors (PPIs) and risk for cardiovascular events, a meta-analysis shows. However, patients with gastroesophageal reflux disease (GERD) do experience a slight increase in cardiovascular events with PPI use.

METHODOLOGY:

• PPIs are commonly used gastric acid suppressants; however, they have pleiotropic effects, some of which have been hypothesized to augment cardiovascular disorders.
• Researchers conducted a meta-analysis of randomized clinical trials with at least 100 patients and treatment durations > 30 days, which compared groups receiving PPIs to those on placebo or other active treatments.
• The primary outcome was a composite of nonfatal myocardial infarctions, nonfatal strokes, fatal cardiovascular adverse events, coronary revascularizations, and hospitalizations for unstable angina.

TAKEAWAY:

• Researchers included data from 52 placebo-controlled trials, with 14,988 patients and 8323 patients randomized to receive a PPI or placebo, respectively; the mean treatment duration was 0.45 person-years for those treated with PPIs and 0.32 person-years for those treated with placebo.
• Among placebo-controlled trials, 24 were conducted in patients with GERD.
• Researchers also included 61 active-controlled trials that compared PPIs with histamine-2 receptor antagonists (51 trials) or other active treatments.
• The incidence rate ratio for the primary outcome was 0.72 when comparing PPI to placebo, indicating no significant association between PPI and cardiovascular events.
• Among patients with GERD, cardiovascular events occurred only in those treated with PPIs, leading to approximately one excess cardiovascular event per 100 person-years of PPI treatment relative to placebo.
• Researchers found no association between PPI treatment and the risk for cardiovascular events in trials comparing PPIs with other active treatments.

IN PRACTICE:

“We found no association of cardiovascular events with PPI treatment,” the authors wrote. “Cardiovascular events appeared more frequent with PPI treatment in GERD trials, but results from this subgroup should be interpreted with the limitations of the analysis in mind.”

SOURCE:

The study, led by Andrew D. Mosholder, MD, MPH, Division of Epidemiology, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, Maryland, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

This study lacked individual patient data, which precluded a time-to-event analysis or an analysis accounting for patient characteristics such as age or sex. The mean duration of PPI treatment in these trials was a few months, limiting the assessment of cardiovascular risk with extended use. The risk estimates were influenced the most by data on omeprazole and esomeprazole.

DISCLOSURES:

This study did not receive any funding. The authors declared no conflicts of interests.

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

TOPLINE:

There is no significant association between the use of proton pump inhibitors (PPIs) and risk for cardiovascular events, a meta-analysis shows. However, patients with gastroesophageal reflux disease (GERD) do experience a slight increase in cardiovascular events with PPI use.

METHODOLOGY:

• PPIs are commonly used gastric acid suppressants; however, they have pleiotropic effects, some of which have been hypothesized to augment cardiovascular disorders.
• Researchers conducted a meta-analysis of randomized clinical trials with at least 100 patients and treatment durations > 30 days, which compared groups receiving PPIs to those on placebo or other active treatments.
• The primary outcome was a composite of nonfatal myocardial infarctions, nonfatal strokes, fatal cardiovascular adverse events, coronary revascularizations, and hospitalizations for unstable angina.

TAKEAWAY:

• Researchers included data from 52 placebo-controlled trials, with 14,988 patients and 8323 patients randomized to receive a PPI or placebo, respectively; the mean treatment duration was 0.45 person-years for those treated with PPIs and 0.32 person-years for those treated with placebo.
• Among placebo-controlled trials, 24 were conducted in patients with GERD.
• Researchers also included 61 active-controlled trials that compared PPIs with histamine-2 receptor antagonists (51 trials) or other active treatments.
• The incidence rate ratio for the primary outcome was 0.72 when comparing PPI to placebo, indicating no significant association between PPI and cardiovascular events.
• Among patients with GERD, cardiovascular events occurred only in those treated with PPIs, leading to approximately one excess cardiovascular event per 100 person-years of PPI treatment relative to placebo.
• Researchers found no association between PPI treatment and the risk for cardiovascular events in trials comparing PPIs with other active treatments.

IN PRACTICE:

“We found no association of cardiovascular events with PPI treatment,” the authors wrote. “Cardiovascular events appeared more frequent with PPI treatment in GERD trials, but results from this subgroup should be interpreted with the limitations of the analysis in mind.”

SOURCE:

The study, led by Andrew D. Mosholder, MD, MPH, Division of Epidemiology, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, Maryland, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

This study lacked individual patient data, which precluded a time-to-event analysis or an analysis accounting for patient characteristics such as age or sex. The mean duration of PPI treatment in these trials was a few months, limiting the assessment of cardiovascular risk with extended use. The risk estimates were influenced the most by data on omeprazole and esomeprazole.

DISCLOSURES:

This study did not receive any funding. The authors declared no conflicts of interests.

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

When psychiatrist Paul Sartain, MD (not his real name), received a letter from his state’s medical board, he was concerned. A patient’s family complained that he made sexual advances to a young woman he treated for psychotic depression.

“There was absolutely no evidence, and the claims were vague,” he said. “I think the family was angry at me and with the system — the woman had not gotten better.” Sartain reviewed his medical records and then called his malpractice insurer.

The insurer asked about his involvement with the patient’s case, if there was anything credible to the patient’s complaint, and if he had thorough documentation. Then, the carrier offered Sartain his choice of several attorneys who could represent him. The medical board ultimately closed the case with no findings against him, and the patient’s family never sued him.

While Sartain said he trusted his carrier-provided attorney, he would have considered hiring his own attorney as well if a criminal issue was also alleged.

“If I’m wrongly accused, I’m defended (by the carrier). If I had stolen money or had a sexual relationship with the patient, then you’re acting outside the bounds of what is protected (by the carrier),” he said.
 

How Medical Board and Malpractice Insurer Investigations Differ

Medical board complaints differ from malpractice claims, in which patients seek damages. The investigation process also varies.

When a patient reports a doctor to a state medical board, they may also sue the doctor for monetary damages in civil court. The medical board responds to patient complaints made directly to them, but it also may also initiate its own investigations. Those can be prompted by a malpractice claim resolution, with a court verdict against the doctor, or a settlement recorded in the National Practitioner Data Bank.

Malpractice insurers may offer limited legal representation for medical board investigations, requiring the doctor to report the medical board issue to them before the doctor takes any action. Often, they will cover up to $50,000 in defense costs but not cover any subsequent medical board fines or required classes or medical board fees.

When a doctor contacts the carrier about a medical board investigation, the carrier may ask for the medical board document and the medical records, said Alex Keoskey, a partner in Frier Levitt’s life sciences group.

The carrier may want to ask about the patient, staff members involved, the doctor’s background, if there have been previous medical board investigations or lawsuits against this doctor, and the doctor’s opinion of the allegations. The doctor should be transparent with the carrier, Keoskey said.

Some carriers conduct more in-depth investigations, examining record-keeping, prescription practices, patient consent processes, and continuing medical education status. That’s because the medical board may inquire about these as well should its own investigation expand.

Not all carriers explore cases like these, even if reimbursing for defense costs, said Karen Frisella, director of professional liability claims at BETA Healthcare Group in California. In her experience, a licensing investigation usually follows a claim resolution that was already worked up by the carrier. If a complaint was made directly to the licensing board without an accompanying liability claim, the carrier’s ability to initiate an investigation on the incident depends on the policy terms or coverage available.

“Typically, a professional liability policy requires that the insured report a claim to trigger coverage. The carrier can’t unilaterally decide to open a claim,” she said. A licensing board investigation is not a claim by definition and therefore does not provide a mechanism for the carrier to open a liability claim file, she added.

If the medical board ultimately restricts the doctor’s license or puts the doctor on probation, that becomes public, and the underwriting department may then look into it.

Malpractice insurers routinely monitor licensing board discipline notices. A reprimand or restrictions on a doctor’s license could trigger a review of the physician’s future insurability and lead to higher premiums or even nonrenewal, Frisella said.

If a carrier investigates a reported claim and determines there are issues with the care rendered, whether there is an accompanying medical board action, that also can affect underwriting decisions, Frisella said.
 

Who Is Your Attorney Really Working for?

The doctor should understand whose interests the attorney represents. In a medical board claim, the attorney — even if defense is paid by the carrier — represents the doctor.

Frisella said her organization provides pass-through coverage, meaning it reimburses the doctor for medical board defense costs. “Because the carrier isn’t directing the medical board defense, it is not generally privy to the work product.”

If a patient files a malpractice claim, however, the attorney ultimately represents the insurance company.

“The panel counsel who works for the insurer does not work for the doctor, and that’s always important to remember,” Keoskey said. While the attorney will do their best to aggressively defend the doctor, “he’s going to protect the insurer’s interest before the doctor’s.”

Physicians who find any conflict of interest with their insurer should seek counsel.

Such conflicts could include:

• Disagreements over the case’s ultimate worth. For example, a physician might want a case to settle for less than their carrier is willing to pay.
• The legal judgment may exceed the carrier’s policy limits, or there are punitive damages or allegations of criminal acts that the insurer does not cover.

In these cases, the insurance company should recommend the doctor get personal counsel. They will send a reservation of rights letter saying they will defend the doctor for now, but if the facts show the doctor committed some type of misconduct, they may decline coverage, said Keoskey. Some states, including California, require that the carrier pay for this independent counsel.

Unless there is a conflict of interest, though, having a personal attorney just makes the situation more complicated, said Frisella.

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

When psychiatrist Paul Sartain, MD (not his real name), received a letter from his state’s medical board, he was concerned. A patient’s family complained that he made sexual advances to a young woman he treated for psychotic depression.

“There was absolutely no evidence, and the claims were vague,” he said. “I think the family was angry at me and with the system — the woman had not gotten better.” Sartain reviewed his medical records and then called his malpractice insurer.

The insurer asked about his involvement with the patient’s case, if there was anything credible to the patient’s complaint, and if he had thorough documentation. Then, the carrier offered Sartain his choice of several attorneys who could represent him. The medical board ultimately closed the case with no findings against him, and the patient’s family never sued him.

While Sartain said he trusted his carrier-provided attorney, he would have considered hiring his own attorney as well if a criminal issue was also alleged.

“If I’m wrongly accused, I’m defended (by the carrier). If I had stolen money or had a sexual relationship with the patient, then you’re acting outside the bounds of what is protected (by the carrier),” he said.
 

How Medical Board and Malpractice Insurer Investigations Differ

Medical board complaints differ from malpractice claims, in which patients seek damages. The investigation process also varies.

When a patient reports a doctor to a state medical board, they may also sue the doctor for monetary damages in civil court. The medical board responds to patient complaints made directly to them, but it also may also initiate its own investigations. Those can be prompted by a malpractice claim resolution, with a court verdict against the doctor, or a settlement recorded in the National Practitioner Data Bank.

Malpractice insurers may offer limited legal representation for medical board investigations, requiring the doctor to report the medical board issue to them before the doctor takes any action. Often, they will cover up to $50,000 in defense costs but not cover any subsequent medical board fines or required classes or medical board fees.

When a doctor contacts the carrier about a medical board investigation, the carrier may ask for the medical board document and the medical records, said Alex Keoskey, a partner in Frier Levitt’s life sciences group.

The carrier may want to ask about the patient, staff members involved, the doctor’s background, if there have been previous medical board investigations or lawsuits against this doctor, and the doctor’s opinion of the allegations. The doctor should be transparent with the carrier, Keoskey said.

Some carriers conduct more in-depth investigations, examining record-keeping, prescription practices, patient consent processes, and continuing medical education status. That’s because the medical board may inquire about these as well should its own investigation expand.

Not all carriers explore cases like these, even if reimbursing for defense costs, said Karen Frisella, director of professional liability claims at BETA Healthcare Group in California. In her experience, a licensing investigation usually follows a claim resolution that was already worked up by the carrier. If a complaint was made directly to the licensing board without an accompanying liability claim, the carrier’s ability to initiate an investigation on the incident depends on the policy terms or coverage available.

“Typically, a professional liability policy requires that the insured report a claim to trigger coverage. The carrier can’t unilaterally decide to open a claim,” she said. A licensing board investigation is not a claim by definition and therefore does not provide a mechanism for the carrier to open a liability claim file, she added.

If the medical board ultimately restricts the doctor’s license or puts the doctor on probation, that becomes public, and the underwriting department may then look into it.

Malpractice insurers routinely monitor licensing board discipline notices. A reprimand or restrictions on a doctor’s license could trigger a review of the physician’s future insurability and lead to higher premiums or even nonrenewal, Frisella said.

If a carrier investigates a reported claim and determines there are issues with the care rendered, whether there is an accompanying medical board action, that also can affect underwriting decisions, Frisella said.
 

Who Is Your Attorney Really Working for?

The doctor should understand whose interests the attorney represents. In a medical board claim, the attorney — even if defense is paid by the carrier — represents the doctor.

Frisella said her organization provides pass-through coverage, meaning it reimburses the doctor for medical board defense costs. “Because the carrier isn’t directing the medical board defense, it is not generally privy to the work product.”

If a patient files a malpractice claim, however, the attorney ultimately represents the insurance company.

“The panel counsel who works for the insurer does not work for the doctor, and that’s always important to remember,” Keoskey said. While the attorney will do their best to aggressively defend the doctor, “he’s going to protect the insurer’s interest before the doctor’s.”

Physicians who find any conflict of interest with their insurer should seek counsel.

Such conflicts could include:

• Disagreements over the case’s ultimate worth. For example, a physician might want a case to settle for less than their carrier is willing to pay.
• The legal judgment may exceed the carrier’s policy limits, or there are punitive damages or allegations of criminal acts that the insurer does not cover.

In these cases, the insurance company should recommend the doctor get personal counsel. They will send a reservation of rights letter saying they will defend the doctor for now, but if the facts show the doctor committed some type of misconduct, they may decline coverage, said Keoskey. Some states, including California, require that the carrier pay for this independent counsel.

Unless there is a conflict of interest, though, having a personal attorney just makes the situation more complicated, said Frisella.

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

When psychiatrist Paul Sartain, MD (not his real name), received a letter from his state’s medical board, he was concerned. A patient’s family complained that he made sexual advances to a young woman he treated for psychotic depression.

“There was absolutely no evidence, and the claims were vague,” he said. “I think the family was angry at me and with the system — the woman had not gotten better.” Sartain reviewed his medical records and then called his malpractice insurer.

The insurer asked about his involvement with the patient’s case, if there was anything credible to the patient’s complaint, and if he had thorough documentation. Then, the carrier offered Sartain his choice of several attorneys who could represent him. The medical board ultimately closed the case with no findings against him, and the patient’s family never sued him.

While Sartain said he trusted his carrier-provided attorney, he would have considered hiring his own attorney as well if a criminal issue was also alleged.

“If I’m wrongly accused, I’m defended (by the carrier). If I had stolen money or had a sexual relationship with the patient, then you’re acting outside the bounds of what is protected (by the carrier),” he said.
 

How Medical Board and Malpractice Insurer Investigations Differ

Medical board complaints differ from malpractice claims, in which patients seek damages. The investigation process also varies.

When a patient reports a doctor to a state medical board, they may also sue the doctor for monetary damages in civil court. The medical board responds to patient complaints made directly to them, but it also may also initiate its own investigations. Those can be prompted by a malpractice claim resolution, with a court verdict against the doctor, or a settlement recorded in the National Practitioner Data Bank.

Malpractice insurers may offer limited legal representation for medical board investigations, requiring the doctor to report the medical board issue to them before the doctor takes any action. Often, they will cover up to $50,000 in defense costs but not cover any subsequent medical board fines or required classes or medical board fees.

When a doctor contacts the carrier about a medical board investigation, the carrier may ask for the medical board document and the medical records, said Alex Keoskey, a partner in Frier Levitt’s life sciences group.

The carrier may want to ask about the patient, staff members involved, the doctor’s background, if there have been previous medical board investigations or lawsuits against this doctor, and the doctor’s opinion of the allegations. The doctor should be transparent with the carrier, Keoskey said.

Some carriers conduct more in-depth investigations, examining record-keeping, prescription practices, patient consent processes, and continuing medical education status. That’s because the medical board may inquire about these as well should its own investigation expand.

Not all carriers explore cases like these, even if reimbursing for defense costs, said Karen Frisella, director of professional liability claims at BETA Healthcare Group in California. In her experience, a licensing investigation usually follows a claim resolution that was already worked up by the carrier. If a complaint was made directly to the licensing board without an accompanying liability claim, the carrier’s ability to initiate an investigation on the incident depends on the policy terms or coverage available.

“Typically, a professional liability policy requires that the insured report a claim to trigger coverage. The carrier can’t unilaterally decide to open a claim,” she said. A licensing board investigation is not a claim by definition and therefore does not provide a mechanism for the carrier to open a liability claim file, she added.

If the medical board ultimately restricts the doctor’s license or puts the doctor on probation, that becomes public, and the underwriting department may then look into it.

Malpractice insurers routinely monitor licensing board discipline notices. A reprimand or restrictions on a doctor’s license could trigger a review of the physician’s future insurability and lead to higher premiums or even nonrenewal, Frisella said.

If a carrier investigates a reported claim and determines there are issues with the care rendered, whether there is an accompanying medical board action, that also can affect underwriting decisions, Frisella said.
 

Who Is Your Attorney Really Working for?

The doctor should understand whose interests the attorney represents. In a medical board claim, the attorney — even if defense is paid by the carrier — represents the doctor.

Frisella said her organization provides pass-through coverage, meaning it reimburses the doctor for medical board defense costs. “Because the carrier isn’t directing the medical board defense, it is not generally privy to the work product.”

If a patient files a malpractice claim, however, the attorney ultimately represents the insurance company.

“The panel counsel who works for the insurer does not work for the doctor, and that’s always important to remember,” Keoskey said. While the attorney will do their best to aggressively defend the doctor, “he’s going to protect the insurer’s interest before the doctor’s.”

Physicians who find any conflict of interest with their insurer should seek counsel.

Such conflicts could include:

• Disagreements over the case’s ultimate worth. For example, a physician might want a case to settle for less than their carrier is willing to pay.
• The legal judgment may exceed the carrier’s policy limits, or there are punitive damages or allegations of criminal acts that the insurer does not cover.

In these cases, the insurance company should recommend the doctor get personal counsel. They will send a reservation of rights letter saying they will defend the doctor for now, but if the facts show the doctor committed some type of misconduct, they may decline coverage, said Keoskey. Some states, including California, require that the carrier pay for this independent counsel.

Unless there is a conflict of interest, though, having a personal attorney just makes the situation more complicated, said Frisella.

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

While a medical peer review occurs once a patient, fellow doctor, or staff member reports that a physician failed to treat a patient up to standards or acted improperly, a “sham peer review” is undertaken for ulterior motives.

Sham peer reviews can be used to attack a doctor for unrelated professional, personal, or nonmedical reasons; intimidate, silence, or target a physician; or to carry out a personal vendetta. They’re typically undertaken due to professional competition or institutional politics rather than to promote quality care or uphold professional standards.

Physicians should be concerned. In a soon-to-be-published Medscape report on peer reviews, 56% of US physicians surveyed expressed higher levels of concern that a peer review could be misused to punish a physician for reasons unrelated to the matter being reviewed.

This is a troublesome issue, and many doctors may not be aware of it or how often it occurs.

“The biggest misconception about sham peer reviews is a denial of how pervasive they are,” said Andy Schlafly, general counsel for the Association of American Physicians and Surgeons (AAPS), which offers a free legal consultation service for physicians facing a sham peer review. “Many hospital administrations are as dangerous to good physicians as street gangs can be in a crime-ridden neighborhood.”

“Physicians should become aware of whether sham peer reviews are prevalent at their hospital and, if so, those physicians should look to practice somewhere else,” Schlafly said in an interview.

Unfortunately, there are limited data on how often this happens. When it does, it can be a career killer, said Lawrence Huntoon, MD, PhD, who has run the AAPS sham peer review hotline for over 20 years.

The physicians at the most risk for a sham peer review tend to be those who work for large hospital systems — as this is one way for hospitals to get rid of the doctors they don’t want to retain on staff, Huntoon said.

“Hospitals want a model whereby every physician on the medical staff is an employee,” Huntoon added. “This gives them complete power and control over these physicians, including the way they practice and how many patients they see per day, which, for some, is 20-50 a day to generate sufficient revenue.”

Complaints are generally filed via incident reporting software.

“The complaint could be that the physician is ‘disruptive,’ which can include facial expression, tone of voice, and body language — for example, ‘I found his facial expression demeaning’ or ‘I found her tone condescending’ — and this can be used to prosecute a doctor,” Huntoon said.

After the complaint is filed, the leaders of a hospital’s peer review committee meet to discuss the incident, followed by a panel of fellow physicians convened to review the matter. Once the date for a meeting is set, the accused doctor is allowed to testify, offer evidence, and have attorney representation.

The entire experience can take a physician by surprise.

“A sham peer review is difficult to prepare for because no physician thinks this is going to happen to them,” said Laurie L. York, a medical law attorney in Austin, Texas.

York added that there may also be a misperception of what is actually happening.

“When a physician becomes aware of an investigation, it initially may look like a regular peer review, and the physician may feel there has been a ‘misunderstanding’ that they can make right by explaining things,” York said. “The window of opportunity to shut down a sham peer review happens quickly. That’s why the physician needs the help of an experienced attorney as early in the process as possible.”
 

If You’re a Victim of a Sham Peer Review

Be vigilant. The most important thing you should think about when it comes to sham peer reviews is that this can, indeed, happen to you, Huntoon said. “I’ve written articles to help educate physicians about the tactics that are used,” he said. “You need to be educated and read medical staff bylaws to know your rights before something bad happens.”

Stay in your job. No matter what, if you’re under review, do not resign your position, no matter how difficult this may be. “A resignation during a sham peer review triggers an adverse report to the National Practitioner Data Bank [NPDB],” Schlafly said. The NPDB is a flagging system created by Congress to improve healthcare quality and reduce healthcare fraud and abuse. “A resignation also waives the physician’s right to contest the unfair review. In addition, leverage to negotiate a favorable settlement is lost if the physician simply resigns.”

Get a lawyer on board early. This is the only way to protect your rights. “Don’t wait a year to get an attorney involved,” Huntoon said. But this also can’t be any lawyer. It’s critical to find someone who specializes in sham peer reviews, so be sure to ask about their experience in handling peer review matters in hospitals and how knowledgeable they are about databank reporting requirements. “Sometimes, doctors will hire a malpractice attorney with no knowledge of what happens with sham peer reviews, and they may give bad advice,” he said. “Others may hire an employment attorney and that attorney will be up on employment law but has no experience with peer review matters in hospitals.”

Given the seriousness of a sham peer review, following these guidelines can help.

Contact the AAPA right away. There are things that can be done early on like getting a withdrawal of the request for corrective action as well as obtaining a preliminary injunction. Preparing for the fallout that may occur can be just as challenging.

“After this situation, the doctor is damaged goods,” Huntoon said. “What hospital will want to hire damaged goods to be part of their medical staff? Finding employment is going to be challenging and opening your own practice may also be difficult because the insurers have access to data bank reports.”

Ultimately, the best advice Huntoon can offer is to do your best to stay one step ahead of any work issues that could even lead to a sham peer review.

“Try and shield yourself from a sham peer review and be prepared should it happen,” he said. “I’ve seen careers end in the blink of an eye — wrongfully.”

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

While a medical peer review occurs once a patient, fellow doctor, or staff member reports that a physician failed to treat a patient up to standards or acted improperly, a “sham peer review” is undertaken for ulterior motives.

Sham peer reviews can be used to attack a doctor for unrelated professional, personal, or nonmedical reasons; intimidate, silence, or target a physician; or to carry out a personal vendetta. They’re typically undertaken due to professional competition or institutional politics rather than to promote quality care or uphold professional standards.

Physicians should be concerned. In a soon-to-be-published Medscape report on peer reviews, 56% of US physicians surveyed expressed higher levels of concern that a peer review could be misused to punish a physician for reasons unrelated to the matter being reviewed.

This is a troublesome issue, and many doctors may not be aware of it or how often it occurs.

“The biggest misconception about sham peer reviews is a denial of how pervasive they are,” said Andy Schlafly, general counsel for the Association of American Physicians and Surgeons (AAPS), which offers a free legal consultation service for physicians facing a sham peer review. “Many hospital administrations are as dangerous to good physicians as street gangs can be in a crime-ridden neighborhood.”

“Physicians should become aware of whether sham peer reviews are prevalent at their hospital and, if so, those physicians should look to practice somewhere else,” Schlafly said in an interview.

Unfortunately, there are limited data on how often this happens. When it does, it can be a career killer, said Lawrence Huntoon, MD, PhD, who has run the AAPS sham peer review hotline for over 20 years.

The physicians at the most risk for a sham peer review tend to be those who work for large hospital systems — as this is one way for hospitals to get rid of the doctors they don’t want to retain on staff, Huntoon said.

“Hospitals want a model whereby every physician on the medical staff is an employee,” Huntoon added. “This gives them complete power and control over these physicians, including the way they practice and how many patients they see per day, which, for some, is 20-50 a day to generate sufficient revenue.”

Complaints are generally filed via incident reporting software.

“The complaint could be that the physician is ‘disruptive,’ which can include facial expression, tone of voice, and body language — for example, ‘I found his facial expression demeaning’ or ‘I found her tone condescending’ — and this can be used to prosecute a doctor,” Huntoon said.

After the complaint is filed, the leaders of a hospital’s peer review committee meet to discuss the incident, followed by a panel of fellow physicians convened to review the matter. Once the date for a meeting is set, the accused doctor is allowed to testify, offer evidence, and have attorney representation.

The entire experience can take a physician by surprise.

“A sham peer review is difficult to prepare for because no physician thinks this is going to happen to them,” said Laurie L. York, a medical law attorney in Austin, Texas.

York added that there may also be a misperception of what is actually happening.

“When a physician becomes aware of an investigation, it initially may look like a regular peer review, and the physician may feel there has been a ‘misunderstanding’ that they can make right by explaining things,” York said. “The window of opportunity to shut down a sham peer review happens quickly. That’s why the physician needs the help of an experienced attorney as early in the process as possible.”
 

If You’re a Victim of a Sham Peer Review

Be vigilant. The most important thing you should think about when it comes to sham peer reviews is that this can, indeed, happen to you, Huntoon said. “I’ve written articles to help educate physicians about the tactics that are used,” he said. “You need to be educated and read medical staff bylaws to know your rights before something bad happens.”

Stay in your job. No matter what, if you’re under review, do not resign your position, no matter how difficult this may be. “A resignation during a sham peer review triggers an adverse report to the National Practitioner Data Bank [NPDB],” Schlafly said. The NPDB is a flagging system created by Congress to improve healthcare quality and reduce healthcare fraud and abuse. “A resignation also waives the physician’s right to contest the unfair review. In addition, leverage to negotiate a favorable settlement is lost if the physician simply resigns.”

Get a lawyer on board early. This is the only way to protect your rights. “Don’t wait a year to get an attorney involved,” Huntoon said. But this also can’t be any lawyer. It’s critical to find someone who specializes in sham peer reviews, so be sure to ask about their experience in handling peer review matters in hospitals and how knowledgeable they are about databank reporting requirements. “Sometimes, doctors will hire a malpractice attorney with no knowledge of what happens with sham peer reviews, and they may give bad advice,” he said. “Others may hire an employment attorney and that attorney will be up on employment law but has no experience with peer review matters in hospitals.”

Given the seriousness of a sham peer review, following these guidelines can help.

Contact the AAPA right away. There are things that can be done early on like getting a withdrawal of the request for corrective action as well as obtaining a preliminary injunction. Preparing for the fallout that may occur can be just as challenging.

“After this situation, the doctor is damaged goods,” Huntoon said. “What hospital will want to hire damaged goods to be part of their medical staff? Finding employment is going to be challenging and opening your own practice may also be difficult because the insurers have access to data bank reports.”

Ultimately, the best advice Huntoon can offer is to do your best to stay one step ahead of any work issues that could even lead to a sham peer review.

“Try and shield yourself from a sham peer review and be prepared should it happen,” he said. “I’ve seen careers end in the blink of an eye — wrongfully.”

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

While a medical peer review occurs once a patient, fellow doctor, or staff member reports that a physician failed to treat a patient up to standards or acted improperly, a “sham peer review” is undertaken for ulterior motives.

Sham peer reviews can be used to attack a doctor for unrelated professional, personal, or nonmedical reasons; intimidate, silence, or target a physician; or to carry out a personal vendetta. They’re typically undertaken due to professional competition or institutional politics rather than to promote quality care or uphold professional standards.

Physicians should be concerned. In a soon-to-be-published Medscape report on peer reviews, 56% of US physicians surveyed expressed higher levels of concern that a peer review could be misused to punish a physician for reasons unrelated to the matter being reviewed.

This is a troublesome issue, and many doctors may not be aware of it or how often it occurs.

“The biggest misconception about sham peer reviews is a denial of how pervasive they are,” said Andy Schlafly, general counsel for the Association of American Physicians and Surgeons (AAPS), which offers a free legal consultation service for physicians facing a sham peer review. “Many hospital administrations are as dangerous to good physicians as street gangs can be in a crime-ridden neighborhood.”

“Physicians should become aware of whether sham peer reviews are prevalent at their hospital and, if so, those physicians should look to practice somewhere else,” Schlafly said in an interview.

Unfortunately, there are limited data on how often this happens. When it does, it can be a career killer, said Lawrence Huntoon, MD, PhD, who has run the AAPS sham peer review hotline for over 20 years.

The physicians at the most risk for a sham peer review tend to be those who work for large hospital systems — as this is one way for hospitals to get rid of the doctors they don’t want to retain on staff, Huntoon said.

“Hospitals want a model whereby every physician on the medical staff is an employee,” Huntoon added. “This gives them complete power and control over these physicians, including the way they practice and how many patients they see per day, which, for some, is 20-50 a day to generate sufficient revenue.”

Complaints are generally filed via incident reporting software.

“The complaint could be that the physician is ‘disruptive,’ which can include facial expression, tone of voice, and body language — for example, ‘I found his facial expression demeaning’ or ‘I found her tone condescending’ — and this can be used to prosecute a doctor,” Huntoon said.

After the complaint is filed, the leaders of a hospital’s peer review committee meet to discuss the incident, followed by a panel of fellow physicians convened to review the matter. Once the date for a meeting is set, the accused doctor is allowed to testify, offer evidence, and have attorney representation.

The entire experience can take a physician by surprise.

“A sham peer review is difficult to prepare for because no physician thinks this is going to happen to them,” said Laurie L. York, a medical law attorney in Austin, Texas.

York added that there may also be a misperception of what is actually happening.

“When a physician becomes aware of an investigation, it initially may look like a regular peer review, and the physician may feel there has been a ‘misunderstanding’ that they can make right by explaining things,” York said. “The window of opportunity to shut down a sham peer review happens quickly. That’s why the physician needs the help of an experienced attorney as early in the process as possible.”
 

If You’re a Victim of a Sham Peer Review

Be vigilant. The most important thing you should think about when it comes to sham peer reviews is that this can, indeed, happen to you, Huntoon said. “I’ve written articles to help educate physicians about the tactics that are used,” he said. “You need to be educated and read medical staff bylaws to know your rights before something bad happens.”

Stay in your job. No matter what, if you’re under review, do not resign your position, no matter how difficult this may be. “A resignation during a sham peer review triggers an adverse report to the National Practitioner Data Bank [NPDB],” Schlafly said. The NPDB is a flagging system created by Congress to improve healthcare quality and reduce healthcare fraud and abuse. “A resignation also waives the physician’s right to contest the unfair review. In addition, leverage to negotiate a favorable settlement is lost if the physician simply resigns.”

Get a lawyer on board early. This is the only way to protect your rights. “Don’t wait a year to get an attorney involved,” Huntoon said. But this also can’t be any lawyer. It’s critical to find someone who specializes in sham peer reviews, so be sure to ask about their experience in handling peer review matters in hospitals and how knowledgeable they are about databank reporting requirements. “Sometimes, doctors will hire a malpractice attorney with no knowledge of what happens with sham peer reviews, and they may give bad advice,” he said. “Others may hire an employment attorney and that attorney will be up on employment law but has no experience with peer review matters in hospitals.”

Given the seriousness of a sham peer review, following these guidelines can help.

Contact the AAPA right away. There are things that can be done early on like getting a withdrawal of the request for corrective action as well as obtaining a preliminary injunction. Preparing for the fallout that may occur can be just as challenging.

“After this situation, the doctor is damaged goods,” Huntoon said. “What hospital will want to hire damaged goods to be part of their medical staff? Finding employment is going to be challenging and opening your own practice may also be difficult because the insurers have access to data bank reports.”

Ultimately, the best advice Huntoon can offer is to do your best to stay one step ahead of any work issues that could even lead to a sham peer review.

“Try and shield yourself from a sham peer review and be prepared should it happen,” he said. “I’ve seen careers end in the blink of an eye — wrongfully.”

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

This summer, the US Food and Drug Administration (FDA) fast-tracked approval of the first-in-its-class nasal epinephrine (neffy). It’s a very welcome addition to our anaphylaxis treatment armamentarium. As the FDA announcement notes, patients with anaphylaxis at times “delay or avoid” anaphylaxis “treatment due to fear of injections.” Neffy was approved on the basis of pharmacokinetic studies. In healthy volunteers, neffy achieved similar serum epinephrine levels, rises in blood pressure, and pulse compared with IM epinephrine. 

The Need for Neffy

It was just a few days ago that I saw a new patient with fire ant anaphylaxis. The last time he tried to use an injectable epinephrine pen, he made two mistakes. First, he placed the wrong end against his thigh, and when it did not inject, he depressed it with his thumb — in other words, he injected his thumb with epinephrine. Of course, that cannot happen with neffy. 

I recall a few years ago, a child experienced anaphylaxis but the parent was hesitant to administer the EAI (epinephrine autoinjector). The parent drove to the emergency room but was delayed by traffic, and by the time they reached the ER, the patient had suffered a respiratory arrest and passed away. 

Patients are not the only ones who are hesitant to administer epinephrine. Some clinicians do not treat anaphylaxis appropriately. As an allergist, I see patients after-the-fact for diagnosis and management. Patients often tell me of systemic allergic reactions treated with IV antihistamines/corticosteroids and even sometimes with nebulized beta agonists, but not epinephrine. 

My opinion is that it’s not just needle phobia. As I mentioned, in my Medscape commentary “Injectable Epinephrine: An Epidemic of Misuse,” I believe it’s due to a misunderstanding of the guidelines and a sense that epinephrine is a potent medication to be used sparingly. Clinicians and patients must understand that epinephrine is a naturally occurring hormone and administration leads to serum levels seen under other natural circumstances (eg, stress — the fight-or-flight surge). The aforementioned article also includes a patient handout, “Don’t Fear Epinephrine,” which I encourage you to read and distribute. 

The potential benefits of neffy are clear: 

• It should overcome fear of injection ergo being more likely to be used, and used earlier, by both patient/family member and clinicians.
• It’s easier to carry than many larger devices (though not the AUVI-Q).
• It cannot be injected incorrectly. 
• Expiration is 8 months longer than the EAI.
• There are no pharmacist substitutions (as there is no equivalent device).

Potential Problems With Neffy and Some Suggested Solutions

As promising and beneficial as it is, I wonder about a few training issues. In the office, patients can be trained with a (reusable) injectable epinephrine trainer but not with a nasal spray device trainer in the office (an important alternative is a small model of a nose in the office for patient education). A training device should also be included in the neffy prescription, as with the EAI.
 

Neffy and Patients With Nasal Polyps or Nasal Surgery

It’s more complicated than that neffy cannot be used with patients who have had nasal polyps or nasal surgery. It’s really about how much healthy nasal mucosa is required for absorption. Nasal surgery may be simple or complex. Nasal polyps may be obstructive or resolved with nasal steroid or biologic therapy. Nasal polyps affect 2% of the population, but 35% of pediatric food allergy (FA) patients develop allergic rhinitis (AR), and these AR symptoms present even when not triggered by FA. AR is present at baseline in patients with FA. How does this influence neffy absorption? For FA patients who have anaphylactic reactions with severe nasal reactions, neffy absorption could be further compromised, something that has not been studied. 

Insurance Coverage

As we don’t yet know the comparative efficacy of neffy in anaphylactic episodes, it’s likely that patients, especially with more severe food sensitivities, will be prescribed both the nasal and IM devices. The question remains whether insurance will cover both. 

In “mild cases,” I suspect that doctors might be more inclined to prescribe neffy.
 

Conclusion

Delay in epinephrine use is frequent despite the clear indication during anaphylactic episodes, which in turn increases risk for mortality. Neffy will probably save many lives. 

Dr. Stadtmauer serves on the advisory board of Medscape. He is in private practice in New York City and is affiliated with the Mount Sinai School of Medicine. 

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

This summer, the US Food and Drug Administration (FDA) fast-tracked approval of the first-in-its-class nasal epinephrine (neffy). It’s a very welcome addition to our anaphylaxis treatment armamentarium. As the FDA announcement notes, patients with anaphylaxis at times “delay or avoid” anaphylaxis “treatment due to fear of injections.” Neffy was approved on the basis of pharmacokinetic studies. In healthy volunteers, neffy achieved similar serum epinephrine levels, rises in blood pressure, and pulse compared with IM epinephrine. 

The Need for Neffy

It was just a few days ago that I saw a new patient with fire ant anaphylaxis. The last time he tried to use an injectable epinephrine pen, he made two mistakes. First, he placed the wrong end against his thigh, and when it did not inject, he depressed it with his thumb — in other words, he injected his thumb with epinephrine. Of course, that cannot happen with neffy. 

I recall a few years ago, a child experienced anaphylaxis but the parent was hesitant to administer the EAI (epinephrine autoinjector). The parent drove to the emergency room but was delayed by traffic, and by the time they reached the ER, the patient had suffered a respiratory arrest and passed away. 

Patients are not the only ones who are hesitant to administer epinephrine. Some clinicians do not treat anaphylaxis appropriately. As an allergist, I see patients after-the-fact for diagnosis and management. Patients often tell me of systemic allergic reactions treated with IV antihistamines/corticosteroids and even sometimes with nebulized beta agonists, but not epinephrine. 

My opinion is that it’s not just needle phobia. As I mentioned, in my Medscape commentary “Injectable Epinephrine: An Epidemic of Misuse,” I believe it’s due to a misunderstanding of the guidelines and a sense that epinephrine is a potent medication to be used sparingly. Clinicians and patients must understand that epinephrine is a naturally occurring hormone and administration leads to serum levels seen under other natural circumstances (eg, stress — the fight-or-flight surge). The aforementioned article also includes a patient handout, “Don’t Fear Epinephrine,” which I encourage you to read and distribute. 

The potential benefits of neffy are clear: 

• It should overcome fear of injection ergo being more likely to be used, and used earlier, by both patient/family member and clinicians.
• It’s easier to carry than many larger devices (though not the AUVI-Q).
• It cannot be injected incorrectly. 
• Expiration is 8 months longer than the EAI.
• There are no pharmacist substitutions (as there is no equivalent device).

Potential Problems With Neffy and Some Suggested Solutions

As promising and beneficial as it is, I wonder about a few training issues. In the office, patients can be trained with a (reusable) injectable epinephrine trainer but not with a nasal spray device trainer in the office (an important alternative is a small model of a nose in the office for patient education). A training device should also be included in the neffy prescription, as with the EAI.
 

Neffy and Patients With Nasal Polyps or Nasal Surgery

It’s more complicated than that neffy cannot be used with patients who have had nasal polyps or nasal surgery. It’s really about how much healthy nasal mucosa is required for absorption. Nasal surgery may be simple or complex. Nasal polyps may be obstructive or resolved with nasal steroid or biologic therapy. Nasal polyps affect 2% of the population, but 35% of pediatric food allergy (FA) patients develop allergic rhinitis (AR), and these AR symptoms present even when not triggered by FA. AR is present at baseline in patients with FA. How does this influence neffy absorption? For FA patients who have anaphylactic reactions with severe nasal reactions, neffy absorption could be further compromised, something that has not been studied. 

Insurance Coverage

As we don’t yet know the comparative efficacy of neffy in anaphylactic episodes, it’s likely that patients, especially with more severe food sensitivities, will be prescribed both the nasal and IM devices. The question remains whether insurance will cover both. 

In “mild cases,” I suspect that doctors might be more inclined to prescribe neffy.
 

Conclusion

Delay in epinephrine use is frequent despite the clear indication during anaphylactic episodes, which in turn increases risk for mortality. Neffy will probably save many lives. 

Dr. Stadtmauer serves on the advisory board of Medscape. He is in private practice in New York City and is affiliated with the Mount Sinai School of Medicine. 

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

This summer, the US Food and Drug Administration (FDA) fast-tracked approval of the first-in-its-class nasal epinephrine (neffy). It’s a very welcome addition to our anaphylaxis treatment armamentarium. As the FDA announcement notes, patients with anaphylaxis at times “delay or avoid” anaphylaxis “treatment due to fear of injections.” Neffy was approved on the basis of pharmacokinetic studies. In healthy volunteers, neffy achieved similar serum epinephrine levels, rises in blood pressure, and pulse compared with IM epinephrine. 

The Need for Neffy

It was just a few days ago that I saw a new patient with fire ant anaphylaxis. The last time he tried to use an injectable epinephrine pen, he made two mistakes. First, he placed the wrong end against his thigh, and when it did not inject, he depressed it with his thumb — in other words, he injected his thumb with epinephrine. Of course, that cannot happen with neffy. 

I recall a few years ago, a child experienced anaphylaxis but the parent was hesitant to administer the EAI (epinephrine autoinjector). The parent drove to the emergency room but was delayed by traffic, and by the time they reached the ER, the patient had suffered a respiratory arrest and passed away. 

Patients are not the only ones who are hesitant to administer epinephrine. Some clinicians do not treat anaphylaxis appropriately. As an allergist, I see patients after-the-fact for diagnosis and management. Patients often tell me of systemic allergic reactions treated with IV antihistamines/corticosteroids and even sometimes with nebulized beta agonists, but not epinephrine. 

My opinion is that it’s not just needle phobia. As I mentioned, in my Medscape commentary “Injectable Epinephrine: An Epidemic of Misuse,” I believe it’s due to a misunderstanding of the guidelines and a sense that epinephrine is a potent medication to be used sparingly. Clinicians and patients must understand that epinephrine is a naturally occurring hormone and administration leads to serum levels seen under other natural circumstances (eg, stress — the fight-or-flight surge). The aforementioned article also includes a patient handout, “Don’t Fear Epinephrine,” which I encourage you to read and distribute. 

The potential benefits of neffy are clear: 

• It should overcome fear of injection ergo being more likely to be used, and used earlier, by both patient/family member and clinicians.
• It’s easier to carry than many larger devices (though not the AUVI-Q).
• It cannot be injected incorrectly. 
• Expiration is 8 months longer than the EAI.
• There are no pharmacist substitutions (as there is no equivalent device).

Potential Problems With Neffy and Some Suggested Solutions

As promising and beneficial as it is, I wonder about a few training issues. In the office, patients can be trained with a (reusable) injectable epinephrine trainer but not with a nasal spray device trainer in the office (an important alternative is a small model of a nose in the office for patient education). A training device should also be included in the neffy prescription, as with the EAI.
 

Neffy and Patients With Nasal Polyps or Nasal Surgery

It’s more complicated than that neffy cannot be used with patients who have had nasal polyps or nasal surgery. It’s really about how much healthy nasal mucosa is required for absorption. Nasal surgery may be simple or complex. Nasal polyps may be obstructive or resolved with nasal steroid or biologic therapy. Nasal polyps affect 2% of the population, but 35% of pediatric food allergy (FA) patients develop allergic rhinitis (AR), and these AR symptoms present even when not triggered by FA. AR is present at baseline in patients with FA. How does this influence neffy absorption? For FA patients who have anaphylactic reactions with severe nasal reactions, neffy absorption could be further compromised, something that has not been studied. 

Insurance Coverage

As we don’t yet know the comparative efficacy of neffy in anaphylactic episodes, it’s likely that patients, especially with more severe food sensitivities, will be prescribed both the nasal and IM devices. The question remains whether insurance will cover both. 

In “mild cases,” I suspect that doctors might be more inclined to prescribe neffy.
 

Conclusion

Delay in epinephrine use is frequent despite the clear indication during anaphylactic episodes, which in turn increases risk for mortality. Neffy will probably save many lives. 

Dr. Stadtmauer serves on the advisory board of Medscape. He is in private practice in New York City and is affiliated with the Mount Sinai School of Medicine. 

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

I’ve worked locum tenens off and on since 1982. Flexible schedules allowed me to write several books, pursue a parallel career as a medical journalist, lead medical missions in the Philippines, and develop modest expertise as an underwater photographer.

But the recent rise in locum tenens practitioners signals trouble for medicine.
 

A Multibillion-Dollar Industry

Roughly 52,000 US doctors work locum tenens full or part time. In annual reports by CHG Healthcare, two thirds of healthcare facilities surveyed report using locums and more than half expect to maintain or increase their use in 2024.

Another measure of the industry’s growth is that membership of The National Association of Locum Tenens Organizations (NALTO), formed in 2001 to lead this fledgling industry, has doubled since 2019. Currently, NALTO has 148 member agencies.