The FDA’s BTC Meeting

J0185152The FDA held an all day public meeting yesterday here in Washington to gain insight into the possibility of a Behind-the-Counter (BTC) designation for drugs.  BTC would be non-prescription, but would require the intervention of a learned intermediary – i.e., the pharmacist, to access the drug.  You would not be able to buy it off the shelf (over-the-counter – OTC) but you could ask the pharmacist about it and after he or she evaluates your issue/condition, it could be supplied to you.

On its face, it may sound reasonable enough.  Drugs, like statins, might be a candidate where a pharmacist could ask the right questions of a patient to help the patient decide what is the best course of action.  But there were six panels of people providing commentary representing a broad range of interests that took very definite pro and con stances on this issue.  Predictably, pharmacists support it and physicians oppose it. 

There already are some drugs that you have to go to the pharmacist to obtain but are OTC, making them in effect, BTC drugs.  For example, you have to go to the pharmacist to get  Plan B – an OTC emergency contraceptive and you have to ask the pharmacist for cold medications that still contain pseudoephedrine.  But those are "policing" duties by the pharmacist.  BTC would actually involve a pharmacist evaluating you and providing you with a drug, meaning that there is a clinical duty. 

There are certainly a host of logistical problems that make this kind of change rather difficult, including liability and insurance issues that would need to be resolved in order to make this successful or not. 

While pharmacists were very willing to stand up and say that they were qualified to deliver this kind of service, one question bugged me.  The idea of BTC is to expand access to drugs that might otherwise remain prescription (RX).  But some pharmacists have argued that they should not have to issue Plan B because of their "religious" or "moral" beliefs.  If those beliefs are going to interfere and trump clinical assessments, then access is actually compromised.  As the number of drugs that might be BTC expands, so would the opportunities for pharmacists to "opt out" of serving consumers and which, in turn, would have a chilling effect on some consumers to approach the pharmacist at all without first knowing they will not be affected by those beliefs. 

This is just one of the many unanswered questions about BTC status that arose during the course of the day.  Resolving them all will take a great deal of time and thought.  I wouldn’t look for it anytime soon. 

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