The FDA announced today that it is exploring the possibility of introducing a "behind the counter" system that would allow more drugs that normally require a prescription to be sold without one.
This type of system would require that a pharmacist ensure that the patients meet minimum requirements to obtain the product and to instruct patients on the proper usage of the medication.
Right now, most drugs are either sold with or without a prescription but there are a few exceptions. One of those exceptions is Barr Pharmaceuticals Inc. (NYSE:BRL) "Plan B", an emergency contraceptive pill, which pharmacists are required to keep behind the counter. It may only be purchased by women who show photo id. to prove they are over the age of 18.
Other countries that already have a "behind the counter" system in place include Australia, Canada, New Zealand, Denmark, Germany, the Netherlands, Sweden and Switzerland.
The FDA is holding a meeting on November 14 and is accepting written or electronic commments from the public, until November 28.
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This is long overdue in the US. A staggering number of patients seek pharmacy treatment for "simple" acute problems. Patient needs are rarely met by the OTC products offered today. Unmet needs may lead to unnecessary ER visits as many patients seek help outside of office hours. A few examples of seemingly non-controversial "behind the counter" products may be: enhanced potency corticosteroid topical agents for poison ivy, bug bites; Epipen for anaphylaxis; and SSD cream for mild to moderate burns. The Plan B system seems to work well while the pseudoephedrine "system" is horrible. Perhaps the "third class" will be a viable hybrid.
Posted by: Darryl Percival | October 4, 2007 5:00 PM | Permalink to Comment