Legal Alert

Related Content

Practices
Industries

Behind the Counter Drugs

January 14, 2008

“Always” and “never” are words seldom used in medicine, but there are exceptions. Two related examples come from elementary pharmacology: no drug has a single action, and all drugs have side effects. The laws of many nations, including ours, are designed to limit the risks inherent in taking medications.

Pharmaceuticals marketed in the U.S. fall legally into two large classes: prescription and non-prescription products. In general, this distinction has served us well. In theory, taking prescription drugs is riskier than taking non-prescription drugs, so limiting distribution to patients whose physicians have made an individual determination of relative safety and sufficient efficacy protects the patient. Non-prescription drugs, typically older and perceived to be safer, may be purchased over-the-counter. But this relatively straightforward delineation is not the only possible schema. In a number of other countries, including Australia, Canada, New Zealand, the UK, and several other EU nations, there are other classes of drugs. The UK has our two, as well as a “pharmacist only” class of drugs. The other countries have more than three classes.

To assign drugs to the “pharmacist only” class, the UK has generally applied two criteria: 1) an indication that, with a pharmacist’s help, is deemed suitable for self-medication, including self-diagnosis, and 2) a comparatively low potential for side effects or overdose. The use of drugs assigned to the pharmacist only category still entails risks; irrespective of legal frameworks, there are no exceptions to the inevitable risk rule. But the risks are thought to be less severe than with use of prescription-only medicines. The requirement for pharmacist interaction is intended to promote safety and effectiveness in use of drugs in this category. It is now proposed that the United States consider establishment of a comparable class of drugs, so called “behind-the-counter” (“BTC”) drugs, to be available without prescription but not without pharmacist advice.

Among the drugs considered for this classification would be epinephrine injections, oseltamivir (Tamiflu, Roche), and oral contraceptives. Epinephrine is needed urgently in a variety of settings where rapid availability may save lives. For example, one who is stung by a bee in the wild and develops anaphylaxis needs treatment immediately; such patients often carry epinephrine for self-injection with them wherever they go. Oseltamivir is a neuraminidase inhibitor; in event of pandemic, its widespread use will be crucial to the effort to contain the devastation. A patient infected with flu may be asymptomatic for 24 hours; the sooner he begins treatment after symptoms appear the better the outcome. After 48 hours, neuraminidase inhibitors are unlikely to change the clinical course. Oral contraceptives are not designed to fight threats to life, of course, but their use has been extremely widespread for decades now and, arguably, fairly safe.

OTC cough and cold preparations for children are also under consideration as candidates for the proposed “BTC” category. On one hand, they have been in use for generations. After recent reports raising safety concerns and a perceived lack of efficacy data, however, sales of children’s cold remedies have been falling precipitously. On November 18, the Washington Post reported at 16% drop in the four weeks ending November 3 as compared to the same 4-week period in 2006. Yet for the parents of symptomatic children, it is agonizing to offer nothing. A BTC approach, it is argued, may achieve a reasonable compromise between knee-jerk treatment and therapeutic nihilism.

Seeking public opinion on the wisdom of establishing a “BTC” class of medications in the U.S., FDA convened a public meeting on November 14, 2007. At the meeting, a number of speakers agreed that creation of this new class of drug would improve access to pharmaceuticals, especially for those without health insurance. Another benefit might be the collection of additional data on drugs as with Phase 4 clinical trials. Critics advocated retaining the existing two-class system; many thought that for the drugs currently proposed as BTC products, the risks are such that medical advice continues to be needed. Nor was there consensus on whether BTC drugs would raise or decrease health care costs. A question of concern to defense counsel must be the effect such a change would have upon the viability of the learned intermediary defense for products sold BTC. The position would most likely have to be that a pharmacist, like a doctor, is also a learned intermediary, and the duty to warn respecting BTC products must continue to run not to patients directly but rather to their health care providers, including pharmacists.