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Dr. Wolfe says that questions remain about the safety, cost and need for a proposed third classification of drugs by the FDA and asks:
• Do pharmacists have the time and training to explain drug use and side effects to customers? If not, who will provide and pay for this training?
• Will pharmaceutical companies pressure the FDA to have some of their prescription drugs reclassified to BTC status to avoid regulation?
• Will lack of physician oversight in the prescribing process turn pharmacies into “drug vending machines” posing increased health risks to the public?
In a notice to its members, the American Pharmacists Association (APA) lists 25 questions that the organization would like input on regarding BTC availability of certain drugs prior to the FDA Public Comment on November 14, 2007. (A link to the full text is provided in the reference list below)
The role of the pharmacist is central to the BTC discussion. The APA list of questions is a thought provoking compilation of topics that need to be addressed if we are to thoroughly grasp the implications of such a ruling by the FDA.
For example, the APA asks “Would special training be needed for other pharmacy staff to aid in managing the work flow (storage, record keeping, distribution) and additional BTC responsibilities of the pharmacist(s) and the pharmacy? If so, what type of training or measures should be put in place? What impact would BTC availability of drugs have on the practice of medicine? ”
These are important questions that require well defined answers if we are to understand who will be accountable for safety issues related to BTC sales of certain drugs. The self prescribing customer may be the one ultimately accountable for requesting a BTC drug. What guidelines can the public look to when they are assessing a need for a drug and require a thorough understanding of both common and infrequent adverse side effects of potential BTC drugs like statins?
Anyone that saw the ABC News 20/20 Undercover Pharmacy investigation earlier this year will certainly want answers to all of the questions the APA poses. It is not unheard of that part time, untrained staff assists pharmacists; especially at busy pharmacy locations across the US.
Canada, the UK, Germany, France, Italy, Denmark, Sweden, Switzerland, the Netherlands, Australia and New Zealand have already reclassified a number of drugs to BTC status. The APA notes that in these countries, “typically, the pharmacist is required to ensure the patient meets certain criteria prior to dispensing, to provide education on proper use, and to monitor”.
Educate, dispense and monitor. Is it realistic to think that these steps can be comprehensively carried out in already busy pharmacies across the US?