OTC Update Reviews New Products, Recalls Since 2020

For the first time since 2019, APhA attendees gathered in person for the annual OTC update, this year covering products that have come to market—or been recalled—since 2020.

Presenter Daniel Krinsky, MS, RPh, owner and president of EduCare4U and PGx101, dove right into the presentation, beginning with a long list of product recalls that have affected the OTC market since 2020. Many, he pointed out, were due to contamination, including the presence of lead in one watermelon-flavored CBD oil tincture and 2 brands of sunscreens with the presence of benzene.

A list of tainted sexual enhancement products covered 4 slides—a “common thread” in every OTC Update presentation, said Krinsky.

New OTC products and products that underwent a prescription to OTC switch included diclofenac sodium 1% topical gel (Voltaren), Aleve X, and Vazalore 81 mg and 325 mg liquid filled caps. Alcaftadine ophthalmic solution 0.25% (Lastacaft), an ocular antihistamine, is also available both online and in other retailers.

“I mention this every year, [but] I think some of these products are best kept near the pharmacy [counter] to allow us to take advantage of opportunities with our patients,” said Krinsky, adding that there may be challenges from a merchandising perspective in separating products that are in similar categories.

A number of new immune support products have also flooded the market, not all of which come from mainstream companies. CBD products have also made their way onto shelves, resulting from a lot of interest in both CBD and medical marijuana. But regulation of CBD products is lacking, with both dosing and dosage form “all over the place,” said Krinsky. “It’s a very complex situation [and] it’s confusing as a pharmacist to help people understand what makes sense and what might be worth talking about, vs what is probably worth ignoring.”

Krinsky also pointed out that oral contraceptives have started to cement themselves firmly in the pharmacists’ wheelhouse, although pharmacist dispensing without a prescription is regulated on a state-by-state basis.

And in another notable change, sale of cough suppressant dextromethorphan is now restricted to adults aged 18 or older in 21 states, requiring an ID check similar to that required to purchase products containing pseudoephedrine.

Later in the presentation, Stefanie Ferreri, PharmD, Smith and Olsen Distinguished Professor at the UNC Eshelman School of Pharmacy took the stage to present 1 of 3 case studies. Ferreri focused on JW, a 37-year-old woman seeking a recommendation for OTC treatment of a runny nose with clear nasal discharge, itchy eyes, and a sore throat.

“There are a lot of differential diagnoses happening in my head right now,” Ferreri said.

Pollen season, she pointed out, has grown by 20 days—with 21% more pollen—over the last 40 years. Climate change, which includes rising temperatures, is creating pollen seasons that are longer and more severe—and associated with subsequent worse outcomes for patients living with asthma and allergies.

For JW, either monotherapy with an intranasal corticosteroid or second-generation oral antihistamine might be appropriate, said Ferreri, encouraging attendees to remember the exclusion criteria for allergic rhinitis: children younger than 12 years, women who are pregnant or lactating, and those exhibiting symptoms of nonallergic rhinitis, otitis media, sinusitis, bronchitis, or lower respiratory diseases. For ocular symptoms, OTC options might include artificial tears, topical olopatadine, or topical ketotifen.

When using OTC products to treat allergic rhinitis, pharmacists have an opportunity to engage in follow-up—an area where, Ferreri said, “we as a profession—where most of health care—falls short.” Monitoring and follow-up is the last part of the pharmacist-patient care process, and pharmacists “can really do a great job in this area.”

Reference

Ferreri S, Krinsky D. Know the facts: OTC update. Presented at: American Pharmacists Association 2022 Annual Meeting & Exposition; March 18-21, 2022; San Antonio, TX.