A Third Category? Medicines Go Behind the Counter

Last year's controversies surroundingwhich patients should be ableto access the emergency contraceptionpill Plan B (levonorgestrel) andthe decongestant pseudoephedrine (PSE)have sent these medications into thepharmaceutical limbo known as behindthe counter (BTC). In a middle groundbetween OTC and prescription-only medicines,these products are designated tobe accessed by patients only after discussionwith the pharmacist and presentingproof of identification (ID). The reasoningbehind putting certain drugs behind thepharmacy counter was to limit their useby those who might misuse them, whilestill maintaining reasonable access forlegitimate patients without making themget a prescription.

Pseudoephedrine (PSE)

A popular and effective decongestant,PSE has been recommended by physiciansand pharmacists for many years.When the Drug Enforcement Administrationfound that it was being used tomake illegal methamphetamine, however,PSE was moved BTC to discouragebulk sales and shoplifting of the drug.Now, patients seeking congestion relieffrom PSE must sign log books in additionto presenting IDs in order to access themedication. Although some pharmacistshoped that this would encourage moredialogue between patients and pharmacistsabout medications, they are findingthat the inconvenience is putting somepatients off PSE altogether.

A number of pharmacists suspect thatsome patients, perhaps unaware of thenew regulation, become confused byreplacement drugs that substitutephenylephrine (PE) for PSE because theyare packaged similarly to the originalproducts. They claim this is one possiblereason behind the drop in sales of suchPSE regulars as Sudafed and its genericequivalents. Alan Rosenthal, RPh, of theSuburban Pharmacy in West Hartford,Conn, fears that patients are accidentallysettling for cold products that are not aseffective as those they can access fromBTC. He admits being asked by patientsabout the efficacy of PE. "I tell them thatPSE is a better product," he said.

Schering-Plough revealedin its third-quarterreport that sales of OTCClaritin had increased 4%to $95 million, due to reformulationwith PE insteadof PSE. Sales of Claritin-D,which still contains PSE,had fallen, however, althoughthe company didnot disclose exact figures.

Plan B

In August 2006, the FDAagreed to approve Plan Bas an OTC medicine forwomen aged 18 andolder. To enforce the regulation, however,pharmacists will have to keep the productBTC; patients seeking the drug mustfirst provide proof of age. Some arguethat this is not true OTC status because itdoes not allow access to medicationsoutside of pharmacist intervention.

Barr Pharmaceuticals, which makesPlan B, began shipping the OTC version topharmacies in mid-November of lastyear. Most major pharmacies, such asWal-Mart, are using the "conscientious-objection" policy, which allows a pharmacistwho objects to selling Plan B onmoral or religious grounds to step awayfrom the transaction and allow a coworkerto complete it. Most other majorchains will also carry the drug, but, surprisingly,some independents are debatingwhether to supply the drug at all dueto lack of previous demand. Ike Vlahos,owner of Jonestown Pharmacy inWinston-Salem, NC, said in the past 2years he has had only 4 prescriptionscome in for Plan B, and he probably willnot carry the OTC version. "I don't knowhow the public will feel about stepping upto the counter and asking for it," he said.

An Official Third Class?

Several countries, including the UnitedKingdom (UK), Canada, and Australia,already have an official class for drugsavailable from BTC, referred to as "pharmacy(P)," "pharmacist only," or"Schedule 3." In the UK, half of the medicinesavailable without a prescription fallinto this category.

To establish a new class of drugs,Congress would have to issue an officialact. It considered doing so in the early1990s, when it studied the US GeneralAccounting Office's report on how third-classdrugs fared in other countries. Thereport effectively shot down the idea ofan American BTC class, stating that theexperience of other countries "does notsupport a fundamental change in the USsystem."

Gary Stein, a government affairs specialistfor the American Society of Health-System Pharmacists, stated that pharmaceuticalcompanies might demandthat the class be established. "If [they]see drugs they'd like to go to OTC statusget rejected, that might encourage theFDA to move to this," he said. Somebrand name manufacturers hope that aBTC class could help them extend thelives of drugs about to go off patent. Asof now, OTC status gives branded drugsabout 3 more years of exclusivity, butdrug makers usually meet with oppositionwhen dealing with medicines forchronic conditions that have no visiblesymptoms, such as high cholesterol.

In January 2005, Merck & Co Inc lost abid to the FDA to have its prescriptioncholesterol-lowering statin drug Mevacor(lovastatin) transferred to OTC status.Members of the FDA advisory panel,however, stated that they could supportoffering it to patients from behind thepharmacists' counter without a prescription.It seems that many on the committeebelieve patients could accuratelydetermine their own need for cholesterol-lowering medications without consultingtheir physicians. Noting that in theUK Zocor (simvastatin) is already offeredunder BTC status, FDA panel memberLeslie Clapp stated that "the BTC scenariowould be a perfect solution" for Mevacor.

Some feel that installing a third class ofmedicine would provide a much neededboost to pharmacists—not just in theirbudgets, but in their morale as well. JanetEngle, associate dean of the University ofIllinois at Chicago College of Pharmacy,stated that, as pharmacists, "none of uswent into the profession to stand behinda counter and count by fives." Sheagreed that pharmacists want tobecome more involved in their patients' health care, and BTC medicines wouldencourage that interaction.

Michael Capka, pharmacist for HappyHarry's in Wilmington, Del, agreed that "itwould help everybody—the public, pharmacists—if there was this third class ofdrugs." He said that one of the most satisfyingthings about the BTC process isbeing able to advise patients about theirconditions when they come to get theirmedicines from BTC. "You can actuallysee a patient's face start to light up."

Others feel a third class of drugs isunnecessary. Virginia Cox of theConsumer Healthcare Products Association,a trade group for nonprescriptiondrugs and dietary supplements,however, expressed hesitation at theinstigation of a third class of drugs—amove that might harm many members ofher group by limiting access to theirproducts. Arthur Levin, director of theCenter for Medical Consumers, said hedoes not see the point of a third drugclass. He says that, although pharmacistsmight reach out for this as an opportunityto counsel patients, "that doesn't happenvery much in the hurly-burly of theretail establishment."

In the UK, enforcement of the BTC statusis occasionally a bit lax. "I've goneinto the UK and bought something BTC,"said Alastair Wood, a pharmacologist atVanderbilt University, who chaired theFDA committee that voted on Mevacor.He stated that when he asked for BTCproducts, most times he was just handedthe product without being asked for ID.Sheila Kelly, executive director of theProprietary Association of Great Britain,explained that "in practice...most [BTC]sales are made to people who havebought the products many times before."Experts in the United States, however,fear that this familiarity would becomean opportunity for such medicines to endup in the wrong hands.

Conclusion

Although several medications havehad to go BTC in the United States inrecent years, the idea of installing an officialthird class has yet to catch on withthe majority of Americans. As morebranded drugs go off patent and facegeneric competition in the "prescription-only"market, however, there may bemore insistence from pharmaceuticalcompanies to reopen the idea of a federallymandated third class of medicines.