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Bulletin Today

To protect infants, FDA advisers recommend RSV vaccine during pregnancy

Members of an FDA advisory panel voted in support of Pfizer’s respiratory syncytial virus (RSV) vaccine (Abrysvo) for the prevention of RSV in infants via administration to pregnant women.

The panel’s 14 advisers unanimously deemed the vaccine effective, while 10 out of 14 said the vaccine was safe. A study by Pfizer indicated that premature delivery was reported in 5.6% of pregnancies in the treatment group compared with 4.7% in the placebo group.

FDA officials said the difference was not statistically significant, but Pfizer said if the drug gets approved, it would track health records for cases of preterm birth and other potential health issues. However, advisers expressed doubt about a plan to use health care billing records data to monitor safety.

CDC estimates that up to 80,000 children younger than age 5 years are hospitalized with RSV each year, and up to 300 die from RSV. The vaccine was tested in approximately 7,300 pregnant people after the 24th week of pregnancy, with about one-half receiving the vaccine and one-half receiving a placebo.

A recent study in NEJM found that during the first 90 days after birth, six infants in the vaccination group contracted a severe case of RSV compared with 33 in the placebo group, indicating an efficacy of almost 82%. For 6 months after birth, the vaccine was found to be 69% effective. During that time, there were 19 babies who became seriously ill in the treatment group compared with 62 in the placebo group. ■


Most Americans likely to seek non-emergency health care at pharmacies

A new survey from Wolters Kluwer Health reflects increasing trust in providers in nontraditional primary care settings.

The survey indicated that roughly 58% of Americans are likely to visit a local pharmacy as a first step when faced with a non-emergency medical issue, and 81% said they trust a pharmacist, nurse, or nurse practitioner to diagnose minor illnesses and prescribe medications.

Additionally, 56% and 54% of Gen Zers and Millennials, respectively, said they visited a local pharmacy to receive care in the past year, compared with 40% of Gen Xers and 35% of Baby Boomers.

About 79% of Americans said they trust their local pharmacy to provide care more than staff at health clinics inside department stores like Target or Walmart. The survey also indicated that 54% of Americans would go to a traditional physician’s office only for vaccinations for children; however, for influenza and other vaccinations for adults, 62% said they would go to a local pharmacy.

Additionally, 37% of U.S. consumers said they decided not to fill a prescription because of cost, and 76% supported converting many widely used, comparatively safe prescription drugs to OTC status. Doing so would help lower costs without compromising safety, according to 74% of Americans.

The survey also revealed that 86% of Americans would receive generic medications if it meant saving money; 92% felt their physician and their pharmacist should inform them of these alternatives; and 36% said they had talked with their pharmacist in the past few months about affording their medications or to see if other options were available. ■


New report finds growth in illegal online pharmacies

A new report from IQVIA Institute for Human Data Science estimates that of 7,310 prescription drugs legally dispensed to U.S. patients between January 2017 and December 2022, roughly 70% (5,085) were being actively marketed and sold by illegal online pharmacies.

IQVIA researchers also estimated that 416 million prescriptions were provided to patients through illegal online pharmacies between January 2017 and December 2022, representing 1.6% of overall prescriptions dispensed from both illegal online and legal pharmacies nationwide.

However, drugs sold through illegal online pharmacies were estimated to generate 10 times higher adverse event rates compared with drugs sold through legal pharmacies, resulting in an estimated 12.6% of total extra adverse events in the United States in connection with drugs purchased through illegal online pharmacies.

These adverse events represent an estimated additional $67 billion cost for the U.S. health care system on top of the health care consequences for patients, according to the report.

From 2019 to 2022, the number of prescriptions dispensed annually through illegal online pharmacies increased from 64 million to 85 million at a compounded annual growth rate of 10%.

Categories of legal therapies with the highest volume share being sold via illegal online pharmacies included drugs used as part of cancer treatment, including hormone therapies, at 10.4% of total volume; sex hormones at 5.5%; dermatologics at 3.4%; other cardiovascular drugs at 3.7%; hormonal contraception at 2.7%; and ADHD drugs at 2.7%.

Motivations for purchasing prescription drugs through illegal online pharmacies include perceived lower prices, off-label use, and stigma. ■


FDA announces updates to warning for all prescription stimulants

To prevent misuse, abuse, and addiction of prescription stimulants, FDA is now requiring their boxed warning—the most prominent warning—to be updated. In addition, the agency is adding more to the prescribing information for all prescription stimulants.

FDA wants to make all prescribing information consistent across this entire class of medications.

“We are adding information that patients should never share their prescription stimulants with anyone, and the Boxed Warning information will describe the risks of misuse, abuse, addiction, and overdose consistently across all medicines in the class,” FDA said. “The Boxed Warning also will advise health care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.”

FDA said that information on these risks is now mandatory in several sections of the prescribing information, including the Warnings and Precautions, Drug Abuse and Dependence, Overdosage, and Patient Counseling sections.

FDA will also require updates to existing patient medication guides to help educate patients and caregivers about the risks of these medications. ■


CDC identifies first-ever drug-resistant ringworm in U.S.

CDC reported that two cases of drug-resistant ringworm infections involving the fungus Trichophyton indotineae were identified in New York City, the first such cases in the country.

According to CDC, the use of conventional treatments has not been successful in treating the infections of the two patients. One of the patients, a woman aged 28 years, developed a rash in the summer of 2021 across a large portion of her upper body, while the other patient, a woman 47 years old, developed a rash across a large portion of her lower body in the summer of 2022.

The older woman was infected with the rash while in Bangladesh, while the other woman had not traveled abroad recently. This suggests that it could be a “potential local U.S. transmission,” according to CDC. Neither woman had underlying health conditions. A dermatologist in New York alerted public health officials of the cases in February.

The infection is typically associated with widespread and inflamed plaques on the body. Earlier cases of drug-resistant ringworm have been reported in Europe, Asia, and Canada.

CDC advised health care providers to expect to give up to 12 weeks of treatment if this species of fungus is detected. ■


Study finds OUD med underprescribed, especially
by race

Findings from a study published May 10, 2023, in NEJM suggest that a key treatment for opioid use disorder (OUD) is underprescribed among patients in the United States, in particular among Black patients.

Roughly more than 20% of patients diagnosed with OUD filled prescriptions for buprenorphine—the gold standard for OUD treatment—from 2016 to 2019, according to the study.

Researchers also found that within 6 months following a high-risk event such as an overdose, white patients filled buprenorphine prescriptions up to 80% more frequently compared with Black patients and up to 25% more frequently compared with Hispanic patients.

In the study, researchers from public health programs at Harvard and Dartmouth evaluated claims filed through Medicare’s disability program for prescriptions of buprenorphine and other addiction treatment drugs. In the 6 months after an episode in which a health care provider had diagnosed the patient with OUD, there were claims for 23,370 patients nationwide. The data show that compared with 18.7% of Latino patients and 23.3% of white patients, just 12.7% of Black patients received any buprenorphine during that 6-month time frame.

Lead study author Michael L. Barnett, MD, who teaches health policy and management at Harvard T.H. Chan School of Public Health, pointed out that access to medical care was not the primary issue in the differences because regardless of race, patients were in contact with physicians approximately once a month. ■


Pharmacy Today regrets an error in the June 2023 issue article, “Xylazine worsens overdose rates, threatens harm reduction efforts.”  The word “adrenergic” was misspelled as “andrenergic.” We apologize for any inconvenience caused.  ■



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