Why do we care about REMS?

Risk Evaluation and Mitigation Strategies (REMS) are safety programs required by FDA to ensure consumers are protected from known risks associated with certain medications. Historically, REMS have been applied to the most “dangerous” meds, and the intensity of the REMS program required has been a function of the level of risk the med poses. Components of REMS may include, for example, MedGuides, patient registries, educational programs for patients, physicians, or pharmacists, leaflets, and “hard stops” to ensure certain lab tests are completed. APhA takes great interest in these programs because practicing pharmacists should play an essential role in patient use of these medications, yet pharmacists are often left out of the planning or the programs themselves. In my view, lack of standardization or attention to workflow issues can lead to higher patient risks, more confusion for health care practitioners, and a missed opportunity for pharmacists to play a greater role.

On October 6 and 7, APhA is hosting a REMS Stakeholder Meeting here in Washington, DC. Our goal will be to develop consensus around a set of principles that FDA could use to guide the work it does with “sponsors,” or the manufacturers who seek approval of their medicines for use in the United States. The timing is important because FDA has been actively engaged in developing greater clarity and standards (for which we have lobbied for years) for REMS. We seek greater standardization so that, for example, if a patient registry is required, a pharmacist could use the demographic data already contained in a pharmacy management system to create the entry for a specific patient, thus improving workflow for both the prescriber and the pharmacist while making life simpler and safer for patients as well.

APhA also seeks appropriate payments for the added yet essential work that must be performed to maintain REMS programs and patient safety. We reason that payments for such activities would not create conflicts related to “steering” a patient toward a particular medication because that particular one has a payment available. The selection of the product would typically have already occurred in most instances. There may be circumstances where a pharmacist, working under a collaborative drug therapy management agreement, might select those products, but again, the selection is guided by a protocol.

Not all pharmacists or pharmacies will be interested in participation in every REMS program. However, we believe every pharmacy should have access to every drug product available. If there are requirements for safe use, any pharmacy or pharmacist should be allowed to qualify.

FDA will be listening. This is an opportunity for pharmacists to play a greater role in patient safety by assuming greater responsibility and authority in the management of products requiring REMS. As pharmacy continues to increase the level of patient services provided, the addition of REMS is a logical next step. We expect the number of products required by FDA to use a REMS program will continue to increase as well. We invite you to share any thoughts you have about your own experiences or opinions, ideally in advance of our REMS conference next month. We would love to factor in your views.