Medications available under "safe use"

Recently I came upon a blog post by APhA CEO Tom Menighan where he brings up the FDA's idea of making certain prescription medications available without a prescription, provided that the medications are provided under conditions of safe use.

This proposal combines a couple of the ideas that have been floating around for several years...a pharmacist-only class of medications as well as limited pharmacist prescribing. Under one safe use provisions, the sale of these agents might be limited to certain health care settings, such as a pharmacy. I emphasize the word might, as Docket No. FDA-2012-N-0171 use the word might rather than would when it discusses whether or not the sales would be restricted to pharmacies.

I believe that this proposal is a step in the right direction for pharmacy. Opening up access to pharmacists as providers with limited prescriptive authority could ease the burden on primary care practitioners and help advance our profession. My concern is that pharmacy will provide this service without ensuring a reimbursement structure for the pharmacists who are providing the service.

We can't continue to give away our services without getting paid because face it, at the end of the day pharmacy is still a business and if your business isn't generating cash-flow it won't be a business very long. This may be the chance that our profession can capitalize on and be granted the provider status that we have been petitioning for over the last several years.

We need to make sure that the regulations contain language that requires pharmacist intervention, not suggests or recommends t. We also need to make sure that provisions are included that allow for reimbursement for services. We can't rely on building the professional fee into the price of the product because people will not see our services as being professional. They will simply look for the pharmacy that has the lowest price and go there. The consultation with the pharmacist must be removed from the product if we truly hope to advance the professional scope of our practice.




Sorry for getting this out so late. The notice came out in the Federal Register on Feb 28 and the deadline for being able to present oral presentations and comments has already passed. However, electronic and written comments will be accepted until May 7, 2012. I encourage you to chime in on this topic.