REMS for Nonprescription Medications

The FDA recently allowed for unrestricted sales of Plan B One-Step (levonorgestrel) for emergency contraception. Previously, Plan B was available as an over-the-counter, or nonprescription, medication to those who could prove to the pharmacist that they were at least 17 years old. For those younger than 17, the medication was available by prescription only.

Putting aside one’s personal feelings regarding who should have access to emergency contraception, relaxing the restrictions on this medication’s availability has the potential to limit the future scope of practice for pharmacists. Let me attempt to explain my rationale.

Ever since I was in pharmacy school, I learned about a third class of drugs, sometimes referred to as behind-the-counter or OTC+. Different from both prescription and nonprescription drugs, these medications would not require a doctor’s prescription, but would be located behind the pharmacy counter and would be allowed for use by a given patient based on the pharmacist’s evaluation and approval. Many in the pharmacy profession have supported this concept for years, and the American Pharmacists Association has had a policy supporting this position since 2006. However, there is currently no FDA-sanctioned regulatory pathway that leads to this designation.

In 2012, the FDA released statements and held public hearings about revising the drug classification system. A term used by the agency in these communications was “conditions of safe use.” These are defined as criteria that would have to be met in order for medications to be made available without a prescription. In essence, you can think of this as a risk evaluation and mitigation strategy (REMS) for non-prescription medications. REMS are required by the FDA for prescription medications when drug products are deemed to have significant risk associated with their use. They range from requiring the distribution of patient information sheets along with prescriptions to placing restrictions on who can prescribe and dispense a given medication.

The imposition of conditions of safe use for a non-prescription medication (or REMS for OTCs) would suggest that the drug has been deemed safe and beneficial for general use, but that certain education or monitoring strategies are required. The classification of Plan B One-Step until recently suggests that it was viewed as this type of medication. It was deemed to be safe for those 17 and older, but required a pharmacist’s evaluation and determination of age before allowing patients to obtain it.

While this type of age-specific review might not be the ideal pharmacist’s evaluation strategy, it did provide a demonstration of how a third class of medications could be managed by pharmacists safely and appropriately. With the removal of age restrictions on Plan B One-Step, there is one less example of a medication with such a restriction.

One might argue that the restrictions on pseudoephedrine provide another example of a medication that fits in this third class. I would suggest, however, that pharmacists have been made responsible for managing this product to minimize its abuse potential rather than so they can determine whether it is the best medication for a given patient. In addition, pseudoephedrine has had non-prescription status for many years, and restrictions were only placed on it due to its abuse potential.

I recognize that discussions of Plan B are frequently emotional, but regardless of your feelings about the medication, it is important to recognize that the recent changes to its status have the potential to limit the practice of pharmacy going forward. We need to actively demonstrate that pharmacists can adequately and safely assess a patient’s condition in the ambulatory setting, providing them medications that are appropriate for their acute or chronic needs.

I would be interested in hearing whether you agree with my perspective as well as what sort of products you think could fit into a third class of drugs.