BTC: Safeguards Needed for Pharmacists

January 1, 2008

In the November issue of Drug Benefit Trends, a Viewpoint titled "How Can We Improve Drug Safety?" and an Editorial titled, "Is the Time Right for a BTC Drug Class?" seemed to send mixed signals about whether there should be a third category of medications stocked behind the counter (BTC) for which pharmacists would provide counseling.

 

In the November issue of Drug Benefit Trends, a Viewpoint titled "How Can We Improve Drug Safety?" and an Editorial titled, "Is the Time Right for a BTC Drug Class?" seemed to send mixed signals about whether there should be a third category of medications stocked behind the counter (BTC) for which pharmacists would provide counseling.

The two examples of drugs already kept behind the counte--Plan B emergency contraception and cough/cold products containing pseudoephedrine-potentially put the pharmacist professionally in harm's way. Sales of Plan B, like alcohol and cigarettes, are restricted to persons meeting a minimum age requirement. If a woman or even a man comes in to buy Plan B, I request documentation of date of birth. I note this information in the pharmacy computer and stick a label onto the package as if it were a prescription. But how do I know the Plan B contraceptive is not going to be given to a 16-year-old, and what is my legal responsibility? When administering vaccines, I can pay an extra fee for liability insurance, but I do not have this protection with BTC products.

I have been in many pharmacies where medications containing pseudoephedrine are sold by a clerk who has the pharmacist sign off on the request-with no questions asked. Even if the pharmacist does ask about a patient's heart health or whether he or she has high blood pressure, some patients do not know or they say something like, "I don't know the numbers, but I know it is okay." Do we accept this information or do we have the right to take the patent's blood pressure in the pharmacy or refuse the sale? You know how it is, the customer is always right!

Now there is discussion of including certain statin drugs in the BTC class, most likely at a lower strength. But many consumers know that by doubling up on the low-dose tablets, they will achieve a prescription strength dose. Will these patients have their cholesterol levels tested before starting to take the statin? After selling the statin, can the pharmacist order a lipid test to see if the statin is having the desired effect? If not, will there be a protocol under which the pharmacist refers the patient to a physician? Will the pharmacist have the legal right to not sell the patient future BTC statin drugs?

These safety issues are not being addressed by pharmaceutical companies that want to sell their drugs to a bigger market. Nor are they being addressed by insurance companies that will look to discontinue coverage of a prescription drug once it becomes available BTC.

In summary, if BTC availability of potent drugs becomes a reality, we will be given half a bone, without the legal or professional rights to do it safely.