US Pharm. 2012;37(6):2.

Citing the fact that it is becoming increasingly more difficult to get patients to see a doctor when they are sick enough to need a prescription and then motivate these patients to actually fill their prescription, the FDA is floating an idea, or as the FDA prefers to call it, a “paradigm,” that would put more prescription drugs in consumers’ hands without requiring a doctor’s visit or a prescription. Hmmm...sounds vaguely familiar to me.  

Actually, this idea is not something unique at all. I remember a flurry of activity early in my career when dozens of prescription drugs were assigned the “Rx to OTC switched” moniker. Over the years, dozens more prescription products attained OTC nonprescription status. And let’s not forget the “Third Class of Drugs” movement and “Behind the Counter” drugs. While today the FDA is attempting to repackage these programs under a new paradigm, the agency continues to struggle with the original obstacles that made the programs untenable among many health care professionals, particularly pharmacists. Such issues include, but are not limited to, the perceived liability to pharmacists in dispensing potent prescription drugs without a prescription; insurance coverage; patients’ out-of-pocket costs; inadequate patient education on the drugs they will be taking; and the potential for abuse and/or overuse of these medications. Nevertheless, despite all of the impediments to getting more prescription drugs into patients’ medicine cabinets without the necessity of a prescription or a doctor’s visit, I still think the idea of pharmacists dispensing certain prescription drugs without a prescription has merit. However, I do not think this is a one-size-fits-all type of program.  

The FDA’s paradigm should include the establishment of an entirely new way of diagnosing and treating patients. Any such program would have to be well thought out so as to integrate the pharmacist’s intensive drug therapy knowledge with the physician’s diagnostic skills. Specific protocols between pharmacists and physicians would have to be established. This would involve the sharing of confidential patient medical records and charts. The pharmacist’s traditional role of filling prescriptions would be assumed by highly trained pharmacy technicians, while pharmacists would spend more of their time with patients reviewing drug therapies and electronically reporting results to the physician so that follow-up visits could be more meaningful and treatments could be changed easily and quickly if necessary. When appropriate, prescription drugs would be dispensed by the pharmacist based on a physician’s detailed diagnosis, possibly by therapeutic category matched to a patient’s health record. In the final analysis, insurance companies should embrace and pay for this kind of professional collaborative effort because patients would be better monitored by both the doctor and the pharmacist, which means less costly hospital or doctor visits, fewer unnecessary insurance claims, and an overall savings to the U.S. health care system.

I know that this futuristic vision will be greeted harshly by many of the same skeptics who simply stood on the sidelines over the years watching the pharmacy profession dissolve into what it is today. Now is the time for pharmacists to take action and insist that any nonprescription drug program include their extensive knowledge and training. From what I can tell, the FDA is finally recognizing the skills and professionalism that pharmacists bring to the table in moving U.S. health care forward. But the key is for pharmacists and their employers to willingly adapt to the new order. I encourage the FDA to move quickly with its plan by fully integrating pharmacists into this emerging health care environment, and I urge pharmacists to write the FDA and let the agency know they are ready to accept and support this truly new paradigm.

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