![]() ![]() “So where do you put drugs like pseudoephedrine, which are required by federal law to be sold behind the counter under direct pharmacist control? How about insulin and syringes, or smoking cessation products that can be sold by pharmacists with specialized training in California and other states? The FDA has been in denial about our de facto third class of BTC drugs for a decade. “The FDA says there are only two classes of drugs in the U.S., OTC and Rx,” said PPSI President Fred Mayer, who is also a member of Drug Topics’ editorial advisory board. Conditions of safe use could include intervention by a pharmacist or other healthcare provider, use of innovative technologies to improve safety, labeling requirements for safe use, or some combination. High-risk drugs would continue to be subject to risk evaluation and mitigation strategies (REMS) lower-risk drugs would be Rx-only.įred MayerA new category would include Rx drugs that have what FDA is calling “conditions of safe use” that would allow Rx products to move to an OTC-like status. At the other end are agents that would not be approved because of excessive risk compared to the potential benefits. At one end of the scale are OTC products judged to carry relatively low risk. The NSURE paradigm is based on a continuum of average risk. The agency is looking at a new paradigm of drug safety with greater flexibility that will benefit patients and public health.” “The FDA says it is not creating a third class of drugs, but that it has the regulatory latitude to allow more pharmacist involvement in the safe use of certain medications. “The FDA is looking to make definitions of prescription and OTC less rigid, so that certain nonprescription medications could be available through what it is calling ‘conditions of safe use,’” said Tom Menighan, BS Pharm, MBA, executive vice president and CEO of the American Pharmacists Association. The goal is to improve patient access to a wider range of medications. In 2012, the agency announced the Nonprescription Safe-Use Regulatory Expansion (NSURE) Initiative. Tom MenighanDeclining to create a third class of drugs does not mean the FDA is content with the status quo. “FDA has not, to date, created a regulatory framework for drugs to be sold ‘behind-the-counter’ and we decline to do so now,” wrote Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research. In March, 2015, FDA turned thumbs down on requests to reclassify Lipitor, Narcan (naloxone Amphaster, Hospira), Chantix (varenicline Pfizer), and Viagra (sildenafil Pfizer) as BTC products. The agency has consistently denied PPSI’s petitions. has filed repeated citizen petitions with FDA to establish a similar class of pharmacist-controlled “behind-the-counter” drugs. See also: Oxytrol goes over-the-counter No plans for BTC drug classĬalifornia-based Pharmacists Planning Services Inc. Zocor Heart-Pro was discontinued in 2010 as a result of low sales, although other OTC versions remain available. Those at higher risk must see a physician for evaluation and, presumably, a higher-dose, Rx-only statin. Those at moderate risk, 10% to 15% over 10 years, can buy a 28-day supply. ![]() Individuals at low risk are ineligible for the drug. It can be sold only after the pharmacist has talked with the patient and determined the individual’s 10-year risk for a major cardiovascular event. pharmacies had to put the product behind the pharmacy counter. ![]() ![]() Zocor Heart-Pro (McNeil) was the first OTC version to market.īut in order to carry the OTC version, U.K. Zocor 10 mg (simvastatin Merck) was switched from Rx to OTC by U.K. There is no middle ground such as the “pharmacist directed” classification used in the United Kingdom (U.K.). Under current regulations, drugs are either Rx or OTC. See also: FDA approves OTC Nexium Behind-the-counter drugs in the U.K. The general acceptance of erectile dysfunction as a condition than can be self-monitored and self-treated really sets up movement toward OTC status.” The massive OTC advertising campaigns behind all of the ED products from their initial approval set the stage for OTC status. “I don’t have a crystal ball, but ED drugs are probably closer to OTC approval than statins. “The two biggest categories vying for OTC status right now are statins and erectile dysfunction drugs,” said David Wendland, vice president of market research consultants, Hamacher Resource Group. The second is space can be found on crowded pharmacy shelves for an entirely new product category. Dave WendlandOne is the FDA, which has already declined to approve an OTC version of Mevacor three times since 2000. ![]()
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