FDA Nears Decision on "Behind the Counter" Medication

The Food and Drug Administration is nearing a decision on its study of the potential behind the counter (BTC) drug category. This would essentially allow pharmacists to prescribe and mange medication without physician intervention. The strongest benefit cited is that giving pharmacists a larger clinical role in patient care will increase access to consumers. The FDA is not certain exactly which drugs, if the program is approved, would be considered for BTC distribution. However, drugs that have been around for a long time and are well known to pharmacists and patients will be considered. Before the drugs are dispensed, the pharmacists will need to perform a clinical evaluation of the patient.

Pharmacists, along with others in favor of the program, argue that some potential benefits include increased access to care, better continuity of care, and increased patient safety. Because patients see pharmacists more often than physicians, access will increase. Pharmacists will also provide more comprehensive information to physicians about patients thus improving the continuity of care. Pharmacists will be able to monitor side effects and adjust dosages thus providing higher quality of care and better patient safety.

Physicians, as a whole, are strongly opposed to the program. AMA trustee, Rebecca J. Patchin, MD, refutes the pharmacists' patient safety argument: "We're concerned about patient safety. If a medication requires oversight, it should be available by prescription, and a physician should be involved in prescribing it and monitoring the patient." AAFP president, Jim King, MD, responds to the access claims: "Patients need a medical home. They don't just need a medication. What's limiting access is the cost of medications, not access to a physician. And there may be a good reason why patients should not be able to get some medications." Dr. Patchin strengthens the access argument by pointing out that many insurance companies will stop including BTC drugs on their formularies making them vastly more expensive for the consumer. In addition, the fact that patients are more likely to change pharmacies than physicians forecasts a decrease in the continuity of care.

The FDA has held public meetings and conferences as well as accepted written opinions on the issue. Now we wait to see if the FDA will take any action. Feel free to voice your opinion in the comments section.

Read: AMA News Article
More Information: FDA BTC Webpage