Last year's controversies surrounding which patients should be able to access the emergency contraception pill Plan B (levonorgestrel) and the decongestant pseudoephedrine (PSE) have sent these medications into the pharmaceutical limbo known as behind the counter (BTC). In a middle ground between OTC and prescription-only medicines, these products are designated to be accessed by patients only after discussion with the pharmacist and presenting proof of identification (ID). The reasoning behind putting certain drugs behind the pharmacy counter was to limit their use by those who might misuse them, while still maintaining reasonable access for legitimate patients without making them get a prescription.
A popular and effective decongestant, PSE has been recommended by physicians and pharmacists for many years. When the Drug Enforcement Administration found that it was being used to make illegal methamphetamine, however, PSE was moved BTC to discourage bulk sales and shoplifting of the drug. Now, patients seeking congestion relief from PSE must sign log books in addition to presenting IDs in order to access the medication. Although some pharmacists hoped that this would encourage more dialogue between patients and pharmacists about medications, they are finding that the inconvenience is putting some patients off PSE altogether.
A number of pharmacists suspect that some patients, perhaps unaware of the new regulation, become confused by replacement drugs that substitute phenylephrine (PE) for PSE because they are packaged similarly to the original products. They claim this is one possible reason behind the drop in sales of such PSE regulars as Sudafed and its generic equivalents. Alan Rosenthal, RPh, of the Suburban Pharmacy in West Hartford, Conn, fears that patients are accidentally settling for cold products that are not as effective as those they can access from BTC. He admits being asked by patients about the efficacy of PE. "I tell them that PSE is a better product," he said.
Schering-Plough revealed in its third-quarter report that sales of OTC Claritin had increased 4% to $95 million, due to reformulation with PE instead of PSE. Sales of Claritin-D, which still contains PSE, had fallen, however, although the company did not disclose exact figures.
In August 2006, the FDA agreed to approve Plan B as an OTC medicine for women aged 18 and older. To enforce the regulation, however, pharmacists will have to keep the product BTC; patients seeking the drug must first provide proof of age. Some argue that this is not true OTC status because it does not allow access to medications outside of pharmacist intervention.
Barr Pharmaceuticals, which makes Plan B, began shipping the OTC version to pharmacies in mid-November of last year. Most major pharmacies, such as Wal-Mart, are using the "conscientious-objection" policy, which allows a pharmacist who objects to selling Plan B on moral or religious grounds to step away from the transaction and allow a coworker to complete it. Most other major chains will also carry the drug, but, surprisingly, some independents are debating whether to supply the drug at all due to lack of previous demand. Ike Vlahos, owner of Jonestown Pharmacy in Winston-Salem, NC, said in the past 2 years he has had only 4 prescriptions come in for Plan B, and he probably will not carry the OTC version. "I don't know how the public will feel about stepping up to the counter and asking for it," he said.
An Official Third Class?
Several countries, including the United Kingdom (UK), Canada, and Australia, already have an official class for drugs available from BTC, referred to as "pharmacy (P)," "pharmacist only," or "Schedule 3." In the UK, half of the medicines available without a prescription fall into this category.
To establish a new class of drugs, Congress would have to issue an official act. It considered doing so in the early 1990s, when it studied the US General Accounting Office's report on how third-class drugs fared in other countries. The report effectively shot down the idea of an American BTC class, stating that the experience of other countries "does not support a fundamental change in the US system."
Gary Stein, a government affairs specialist for the American Society of Health- System Pharmacists, stated that pharmaceutical companies might demand that the class be established. "If [they] see drugs they'd like to go to OTC status get rejected, that might encourage the FDA to move to this," he said. Some brand name manufacturers hope that a BTC class could help them extend the lives of drugs about to go off patent. As of now, OTC status gives branded drugs about 3 more years of exclusivity, but drug makers usually meet with opposition when dealing with medicines for chronic conditions that have no visible symptoms, such as high cholesterol.
In January 2005, Merck & Co Inc lost a bid to the FDA to have its prescription cholesterol-lowering statin drug Mevacor (lovastatin) transferred to OTC status. Members of the FDA advisory panel, however, stated that they could support offering it to patients from behind the pharmacists' counter without a prescription. It seems that many on the committee believe patients could accurately determine their own need for cholesterol- lowering medications without consulting their physicians. Noting that in the UK Zocor (simvastatin) is already offered under BTC status, FDA panel member Leslie Clapp stated that "the BTC scenario would be a perfect solution" for Mevacor.
Some feel that installing a third class of medicine would provide a much needed boost to pharmacistsnot just in their budgets, but in their morale as well. Janet Engle, associate dean of the University of Illinois at Chicago College of Pharmacy, stated that, as pharmacists, "none of us went into the profession to stand behind a counter and count by fives." She agreed that pharmacists want to become more involved in their patients' health care, and BTC medicines would encourage that interaction.
Michael Capka, pharmacist for Happy Harry's in Wilmington, Del, agreed that "it would help everybodythe public, pharmacistsif there was this third class of drugs." He said that one of the most satisfying things about the BTC process is being able to advise patients about their conditions when they come to get their medicines from BTC. "You can actually see a patient's face start to light up."
Others feel a third class of drugs is unnecessary. Virginia Cox of the Consumer Healthcare Products Association, a trade group for nonprescription drugs and dietary supplements, however, expressed hesitation at the instigation of a third class of drugsa move that might harm many members of her group by limiting access to their products. Arthur Levin, director of the Center for Medical Consumers, said he does not see the point of a third drug class. He says that, although pharmacists might reach out for this as an opportunity to counsel patients, "that doesn't happen very much in the hurly-burly of the retail establishment."
In the UK, enforcement of the BTC status is occasionally a bit lax. "I've gone into the UK and bought something BTC," said Alastair Wood, a pharmacologist at Vanderbilt University, who chaired the FDA committee that voted on Mevacor. He stated that when he asked for BTC products, most times he was just handed the product without being asked for ID. Sheila Kelly, executive director of the Proprietary Association of Great Britain, explained that "in practice...most [BTC] sales are made to people who have bought the products many times before." Experts in the United States, however, fear that this familiarity would become an opportunity for such medicines to end up in the wrong hands.
Although several medications have had to go BTC in the United States in recent years, the idea of installing an official third class has yet to catch on with the majority of Americans. As more branded drugs go off patent and face generic competition in the "prescription-only" market, however, there may be more insistence from pharmaceutical companies to reopen the idea of a federally mandated third class of medicines.