FDA approves Rx-to-OTC switch of head lice removal product

In October, FDA approved a prescription (Rx)-to-OTC conversion for the head lice removal product ivermectin (Sklice) 0.5% lotion. Health care experts and others hope OTC availability of will improve patients' accessibility to treatment. “I agree with change from OTC, as it [will] increase access this medication—no doctor visit needed or delay in treatment due lack available timely appointments [especially during pandemic],” said Anh Lam, PharmD, clinical pharmacist at Tufts Medical Center's Dermatology department Boston, MA. Below are some commonly asked questions about what Rx-to-OTC means. Ivermectin is topical pediculicide lotion indicated infestations patients ages 6 months older. It single-use straightforward easy-to-follow directions: Apply thoroughly dry scalp hair 10 minutes, then rinse out water. two studies, yielded higher proportion participants free live 14 days after compared vehicle control (76.1% 71.4% vs. 16.2% 18.9%, respectively). According “the medication generally well tolerated, minimal side effects such skin irritation, burning, conjunctivitis, eye irritation.” Since safe effective no need worry adherence combing nits—even though not ovicidal—it an appropriate switch. “Lice so difficult get rid because treatments only kill bugs—and they don't always all them—but do nits. All current require combing, proper true skill,” Melissa Balick, former business owner Hair Heroes Philadelphia. recent years, has grown resistant common like permethrin (Nix) synergized pyrethrins (Rid). Because have been widely many decades, used overused quite time, according William Ryan, BVSc, development Sklice. Retreatment by ill-informed also contributes inevitable resistance. Ironically, switch status brings up question affordability. “One my concerns price product,” Lam. Right now, she said, costs around $250 version GoodRx coupon. manufacturer retail pharmacies negotiate rebates make more affordable [for] patients,” Lam said. insurances cover products, high out-of-pocket cost would likely deter using ivermectin. Furthermore, product, contribute toward patient's deductible premium, ultimately defeating purpose approval that intended promote public health medication. pharmacists should counsel them aware part comprehensive program. Other important components removal, include washing hot water clothing, bedding, towels, other items touched patient, household members, close contacts. The American Academy Pediatrics recommends rinsing pediculicides off warm, rather than hot, sink minimize absorption unnecessary exposure. Especially children, avoid direct head-to-head contact prevent transmission. A single be three times if appears ineffective resistance improper use, CDC. “Switching [such as] pyrethrins, permethrin, malathion, benzyl alcohol, spinosad could next step,” Although oral option when therapies failed, monitor adverse systemic effects. recommended pregnant women children weighing less 15 kg safety data. Tabled 1Rx-to-OTC switches 2020Drug name (active ingredient)IndicationApproval dateSklice (ivermectin, 0.5%) lotionPediculicide infestations10/27/2020Pataday Once Daily Relief (olopatadine hydrochloride, 0.7%) ophthalmic solutionAntihistamine temporary relief itchy red eyes pollen, ragweed, grass, animal hair, dander7/13/2020Voltaren Arthritis Pain (diclofenac sodium, 1%) gelNSAID osteoarthritis pain joints, knees hands2/14/2020Pataday Twice 0.1%) dander2/14/2020Pataday 0.2%) solution Open table new tab Pharmacists encourage ask questions, especially prescribers bypassed use process, products. “I've had customers who told me got stuff, but hadn't worked,” Balick. “However, comes lice, people's personal experiences cannot really trusted understand little actually required lice. So, perhaps stuff did work, mistook dead nits sign infestation. Or, commonly, child simply again same place first time.”