US regulators are looking at the possibility of making more medicines available at pharmacies without the need for a prescription.
The US Food and Drug Administration has announced a public meeting, to be held on November 14 in Washington DC in order to gauge opinion about the possibility of behind-the-counter (BTC) availability of certain drugs. The agency added that it is interested in the possibility of adding a third category of medicines (after prescription and over-the-counter drugs) but only after intervention by a pharmacist.
Some groups have argued that pharmacists have “the training and knowledge” to ensure that drugs could be sold BTC, the FDA noted, and the availability of certain products in that manner could increase patient access to underutilised drugs, particularly by those people who do not have health insurance. The agency adds that other countries operate variations of BTC status, namely Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland. In the UK, there is a ‘pharmacist-only’ class and some countries have more than three types of classification.
The FDA is also looking for suggestions on what role a pharmacist should play in counselling as well as monitoring patients' use of a BTC and what measures need to be put in place to ensure safety. In 2005, an FDA advisory committee knocked back Merck & Co’s bid to win over-the-counter approval of its cholesterol-lowering product, Mevacor (lovastatin), after raising doubts over whether patients would be able to take the product safely without a doctor’s input, but members of the committee said they would have backed non-prescription status had there been a BTC option.
The response to the FDA’s proposal for an intermediary category has been lukewarm. It was welcomed by the American Pharmacists Association, but other groups are saying that the effectiveness of such a scheme would depend on which type of treatments should get BTC status. At the moment very few BTC drugs are available in the USA, the most notable being Barr’s Plan B birth control drug and a couple of years ago.