The Life Cycle of a Drug: Behind-the-Counter Drugs

OK, this drug classification doesn't officially exist in the US. I was recently reminded of the ASHP's advocacy for its creation while reading speculation about Pfizer's marketing strategies for Lipitor after its patent monopoly ended. The speculation was confirmed by Drew Armstrong at Bloomberg. Given the FDA's most recent drug safety bulletin about statins and its multiple rejections of statin OTC applications by Merck and Bristol-Myers, probably the only chance of making these drugs more accessible to the public will be the creation of a BTC category such as exists for simvastatin in the UK, where there is a written risk evaluation and monitoring. Even then, many in the UK and the US do not favor any evaluation that doesn't include blood HDL, LDL, triglycerides, and total cholesterol levels. Considering the number of in-store clinics that are being opened in the US alongside pharmacies, perhaps this will eventually occur.

My larger point is that FDA designation of some drugs for non-prescription BTC dispensing might be very helpful in making those medications more accessible to the public with sufficient safety provided by one or more health professionals in a clinic and/or pharmacy. I definitely favor more use of pharmacists' expertise. Another reason that there would need to be a new category is that pharmacists will need a mechanism to be paid for time spent evaluating, advising and monitoring BTC drugs. The money might be well spent for the opportunity to draw people into preventive care while avoiding adverse drug reactions.