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Tuesday, January 3, 2023

Mental Health Conditions Among Cardiologists

 


DOI: 10.1016/j.jacc.2022.11.025

Abstract

Background

Mental illness among physicians is an increasingly recognized concern. Global data on mental health conditions (MHCs) among cardiologists are limited.

Objectives

The purpose of this study was to investigate the global prevalence of MHCs among cardiologists and its relationships to professional life.

Methods

The American College of Cardiology conducted an online survey with 5,931 cardiologists globally in 2019. Data on demographics, practice, MHC, and association with professional activities were analyzed. The P values were calculated using the chi-square, Fischer exact, and Mann-Whitney U tests. Univariate and multivariate logistic regression analysis determined the association of characteristics with MHC.

Results

Globally, 1 in 4 cardiologists experience any self-reported MHC, including psychological distress, or major or other psychiatric disorder. There is significant geographic variation in MHCs, with highest and lowest prevalences in South America (39.3%) and Asia (20.1%) (P < 0.001). Predictors of MHCs included experiencing emotional harassment (OR: 2.81; 95% CI: 2.46-3.20), discrimination (OR: 1.85; 95% CI: 1.61-2.12), being divorced (OR: 1.85; 95% CI: 1.27-2.36), and age <55 years (OR: 1.43; 95% CI: 1.24-1.66). Women were more likely to consider suicide within the past 12 months (3.8% vs 2.3%), but were also more likely to seek help (42.3% vs 31.1%) as compared with men (all P < 0.001). Nearly one-half of cardiologists reporting MHCs (44%) felt dissatisfied on at least one professional metric including feeling valued, treated fairly, and adequate compensation.

Conclusions

More than 1 in 4 cardiologists experience self-reported MHCs globally, and the association with adverse experiences in professional life is substantial. Dedicated efforts toward prevention and treatment are needed to maximize the contributions of affected cardiologists.

https://www.jacc.org/doi/10.1016/j.jacc.2022.11.025

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Kids' Unintentional Exposures to Edible Cannabis on the Rise

 Pediatric exposures to edible cannabis products increased more than 10-fold in recent years, according to a retrospective analysis of the National Poison Data System.

From 2017 to 2021, unintentional ingestions of cannabis edibles among U.S. children younger than 6 years rose from 207 to 3,054 cases, with almost all exposures (97.7%) occurring in a residential setting, reported Marit Tweet, MD, of Southern Illinois University School of Medicine in Springfield, and colleagues in Pediatricsopens in a new tab or window.

"Unintentional exposure to cannabis edibles in children has become a significant public health issue, and there is a large number of children at risk

opens in a new tab or window given how common these products have become," co-author Antonia Nemanich, MD, of Rush University Medical Center in Chicago, told MedPage Today.

The group found that over half of all cannabis exposures occurred in 2- and 3-year-olds (27.7% and 24.6%, respectively).

"The natural curiosity and climbing ability of toddlers means that they can often get into edibles stored on a high shelf or in a plain-looking closed container," Nemanich said.

Of all 7,043 reported cases during the 5-year study period, 4,827 had a known outcome: 70% were reported to have central nervous system (CNS) depression, followed by tachycardia (11.4%), vomiting (9.5%), mydriasis (5.9%), and respiratory depression (3.1%).

No deaths were reported. Overall, 22.7% were admitted to hospital, including 573 to the intensive care unit (ICU), Tweet and colleagues noted.

While the findings add to reports of increasing pediatric cannabis exposuresopens in a new tab or window associated with widespread legalizationopens in a new tab or window (which in some states coincided with pandemic lockdowns), the rise in both ICU and non-ICU admissions was particularly notable during the pandemic years, when cases increased by 296% from prepandemic years. Tweet and co-authors suggested this may have been related to COVID-related quarantines and school/daycare closures, thus increasing the opportunities for exposure at home, as well as possibly higher levels of cannabis use due to increased stress or more leisure time.

The proportion of critical care admissions remained unchanged, accounting for around 9% of all cases in 2017 and in 2021, the investigators noted. Noncritical care admissions increased from 9.7% to 16.3%, respectively.

However, a comparison of prepandemic to pandemic rates showed that admissions for critical care increased by 30%, from 6.6% in 2017-2019 to 8.6% in 2020-2021 (P<0.05). The number of patients treated and released at the emergency department (ED) declined from approximately 41% in the prepandemic years to 35% during the COVID years (P<0.05).

Major effect cases (n=155 over the study period) increased from 1.6% of all cases during the prepandemic years to 2.4% during the pandemic years, while moderate effect cases (n=1,539 in total) increased from 15.9% to 23.8%, respectively (P<0.05).

The authors noted an increase in acute toxicity, "as indicated by increasing critical care admissions, more patients admitted to noncritical care beds, and fewer patients being treated and released from the ED." These unexplained changes may be related to providers' increased experience and comfort with managing these cases, bed availability during the pandemic, or other factors, the researchers noted.

Cannabis intoxication can present with a wide range of potential symptoms that differ from patient to patient, Nemanich explained. "One of our roles as consulting medical toxicologists is to help ED doctors appropriately gauge their degree of concern in these exposures and prevent unnecessary ICU admissions and transfers."

The most common therapies provided were intravenous fluids (20.7%), dilution/irrigation/washing (10.9%), and food/snack (10.3%), with oxygen therapy used in 4% of cases, showing that "life-threatening sequelae can develop and may necessitate invasive supportive care measures," the researchers said.

Despite growing awareness of pediatric cannabis exposures, and the 2019 release of prevention recommendationsopens in a new tab or window by the American College of Medical Toxicology, "our study shows a continued increase in pediatric cannabis exposures after these guidelines came out and highlights how important it is to increase efforts to educate the public about prevention strategies," Tweet and co-authors wrote.

Nemanich recommended that pediatricians and family practice doctors should screen for cannabis use -- and specifically edible use -- so they can educate caregivers, emphasizing locked storage, using edibles only when children are not watching, and putting edibles away immediately after use. "A non-judgmental approach is vital, since caregivers are unlikely to be forthcoming if they worry about being judged or having child protective services involved if they admit to drug use," she emphasized.

"As well, patients with a cannabis exposure that is not known to providers may get a very extensive work-up for life-threatening problems such as stroke, sepsis, or meningitis, in addition to toxicologic causes," Nemanich added. "The more forthcoming parents are about what items are in the home, the more likely this can be avoided."

Study limitations, the researchers said, included underestimation of the actual number of cannabis exposures in this age group, and missing data for patients lost to follow-up.

Disclosures

Tweet, Nemanich, and co-authors reported that they have no potential conflicts of interest to disclose.

Primary Source

Pediatrics

Source Reference: opens in a new tab or windowTweet MS, et al "Pediatric edible cannabis exposures and acute toxicity: 2017-2021" Pediatrics 2023; DOI: 10.1542/peds.2022-057761.


https://www.medpagetoday.com/emergencymedicine/emergencymedicine/102485

Screen All Surgery Patients for Cannabis Use, New Guidelines Say

 Surgical candidates undergoing anesthesia should be screened universally for cannabis use, new guidelines from the American Society of Regional Anesthesia and Pain Medicine (ASRA Pain Medicine) stated.

Anesthesiologists should ask all patients about the type of cannabis product used, whether it was smoked or ingested, the amount used, how recently it was used, and the frequency of use, reported Shalini Shah, MD, of the University of California Irvine, and colleagues in Regional Anesthesia & Pain Medicineopens in a new tab or window.

Anesthesiologists also should be prepared to possibly change the anesthesia plan or delay surgery, the authors noted. They should let patients know that regular cannabis users may have more pain and nausea after surgery and may need more medications to manage post-surgical pain.

The guidance is the first in the U.S. about cannabis and perioperative management.

Cannabis is the most commonly used recreational drug in the U.S. and the most commonly used psychoactive substance after alcohol, noted guideline co-author and ASRA Pain Medicine president Samer Narouze, MD, PhD, of Northeast Ohio Medical University in Akron.

About 10% of the population -- 27.6 million people -- reported monthly use in 2017, according to data from the Substance Abuse and Mental Health Services Administration (SAMHSA) and that number is growing, Narouze added. Recent Gallup poll numbers place the number of Americans who smoke marijuanaopens in a new tab or window at about 16%.

"That's why we've been working on these guidelines for the last 2 years, because we have millions of people using cannabis recreationally or medicinally," Narouze said in an interview with MedPage Today.

"Every day, people who use cannabis present for surgery," he pointed out. "We've seen some observational studies about this in the literature, but there have been no randomized control trials."

But even in observational studies, patterns were clear, Narouze noted."The main issue we're seeing is more pain in recovery and more nausea and vomiting, also in recovery," he observed.

"We also saw associations with increased risk for post-operative cardiovascular morbidity -- post-operative myocardial infarction and arrhythmias -- and post-operative cerebrovascular morbidity in some patients," he said.

Cannabis had varying interactions with anesthetics and sedatives, Narouze added. Some patients also experienced post-operative cannabis withdrawal symptoms.

The guidelines stemmed from a literature review and other work from the ASRA Pain Medicine guideline committee. A consensus recommendation required at least 75% agreement of the committee's 13 experts.

The committee used the U.S. Preventive Services Task Force (USPSTF) process of assigning an A, B, C, or D letter grade (or I for insufficient) based on evidence strength.

Recommendations receiving an A grade included screening all patients before surgery, postponing elective surgery if patients had altered mental status, counseling heavy users about potentially negative effects of cannabis on post-operative pain control, and counseling pregnant patients on risks associated with cannabis use.

Those receiving a B grade were counseling patients on potential perioperative risks associated with continuing cannabinoids and discouraging cannabis use during pregnancy and immediately after childbirth.

C grade recommendations included delaying elective surgery for at least 2 hours after patients smoked cannabis, adjusting anesthesia delivery based on symptoms and timing of last cannabis consumption, increasing vigilance of potential heart and neurological problems after surgery, using multimodal pain control including opioids if needed, and using a cannabinoid agonist like dronabinol to treat severe cannabis withdrawal symptoms post-operatively.

"There's a large gap in our knowledge about cannabis and surgery," Narouze stated. "That's why most recommendations did not reach the grade A level."

"However, we do not want to underestimate the information we gather from observational and large data studies, because this is real-world data," he said.

The ASRA Pain Medicine task force will continue monitoring new research as it becomes available, Shah and colleagues noted. The group may revise the entire document or specific sections if new evidence warrants updated recommendations.

Disclosures

Shah disclosed relationships with Masimo, Allergan, and SPR Therapeutics. Narouze and other co-authors disclosed no relationships with industry.

Primary Source

Regional Anesthesia and Pain Medicine

Source Reference: opens in a new tab or windowShah S, et al "ASRA pain medicine consensus guidelines on the management of the perioperative patient on cannabis and cannabinoids" Reg Anesth Pain Med 2023. doi: 10.1136/rapm-2022-104013.


https://www.medpagetoday.com/surgery/anesthesiology/102488

Acadia Pharma upped to Buy from Neutral by Guggenheim

 Target $22

https://finviz.com/quote.ashx?t=ACAD&p=d

Phathom Down on Delayed Vonoprazan Launch Following FDA Decision

 Phathom Pharmaceuticals Inc. shares tumbled 27% to $8.70 in after-hours trading Tuesday following a decision by the Food and Drug Administration to take no action on the company's new drug application for vonoprazan.

The biopharmaceutical company said it no longer expects product launches for H. pylori or erosive esophagitis in the first quarter of 2023. The outlook comes after it detected trace levels of nitrosamine impurity in commercial batches in August. The company said at the time it was working with the FDA to obtain approval of a proposed acceptable daily intake limit, test method and controls to address the impurity before releasing vonoprazan, a potassium-competitive acid blocker, based products to the market.

Phathom said the FDA has requested additional stability data demonstrating that levels of nitrosamine remain below the limit throughout the proposed shelf life of the product despite an acceptable daily intake limit for the nitrosamine impurity being established.

"While we are disappointed not to launch vonoprazan later this quarter, we are otherwise very pleased with the NDA review progress, including ongoing label negotiations which we are optimistic will conclude shortly, " said Chief Executive Terrie Curran.

Trading was halted at 4 p.m. EST ahead of the news and resumed 30 minutes later. The stock, which closed up 6.9% to $11.99 in regular trading, is down 40% over the last 12 months.

https://www.marketscreener.com/quote/stock/PHATHOM-PHARMACEUTICALS-69788315/news/Phathom-Pharmaceuticals-Shares-Tumble-27-on-Delayed-Vonoprazan-Launch-Following-FDA-Decision-42652855/

PDS Biotech, Merck Germany in Licensing Pact For Investigational Cancer Treatment

 

  • PDS Biotechnology Corporation  announced an exclusive global license agreement with Merck KGaA 
    MKGAF
     
    MKKGY
     for the tumor-targeting IL-12 fusion protein M9241 (formerly known as NHS-IL12), which will join the pipeline as PDS0301. 
  • Under the terms of the agreement, PDS Biotech will receive from Merck KGaA an exclusive license to M9241. 
  • PDS Biotech will assume responsibility for the future development, commercialization, and manufacturing of M9241.
  • Under the terms of the agreement, Merck KGaA will receive an upfront cash payment of $5 million and will be entitled to up to $11 million in development and regulatory milestone payments, including first commercial sales for the first two indications, and up to $105 million in commercial milestones, and a 10% royalty on future sales of M9241 with standard step-down provisions. 
  • Merck KGaA will receive 378,787 shares of PDS Biotech's shares valued at $5 million.