REMS: You've Heard About It, but Do You Understand It?


Pharmacists have an obligation to counsel patients effectively on medications with risk evaluation mitigation strategy.

One of the most prominent and distinguishing features between specialty and non-specialty medications is the importance of risk mitigation. Now, before you jump all over me, let me clear the air.

Yes, there is always an inherent need for a pharmacist to mitigate the risks associated with every medication. However, the need to provide this service has taken on a new meaning with specialty medications.

These types of medications have a documented history of being able to produce amazing outcomes within its intended population. Having the potential for a great reward does not come without the possibility of great risks. Because of this, specialty medications require the clinical expertise of pharmacists like never before.

However, there some specialty medications that require the need to go above and beyond to ensure optimal outcomes. This has come to be known as the risk evaluation mitigation strategy (REMS).

REMS programs are safety strategies proposed by the FDA that are premised on the management of known and/or potentially significant risks associated with certain medications.

The idea of risk mitigation, to this degree, is not a new concept. In fact, REMS actually was formed back in the 1960s as a result of the thalidomide tragedy.

During the late 1950s, thalidomide—an immunomodulatory used to treat leprosy—was administered to pregnant women for the treatment of nausea in Europe, Australia, and Japan. While it proved effective in reducing nausea, underneath the surface it was having a far greater effect.

When the children of these mothers were born, the resulting use of thalidomide was found to cause a severe birth defect known as phocomelia, a shortening or absence of limbs. This immediately gave rise to the ban of the medication in many countries. In the United States, this tragedy was averted before there was ever an opportunity for it to begin.

Before the thalidomide tragedy could occur here at home, the medication was blocked from approval by the FDA. There were concerns about peripheral neuropathy, sometimes irreversible, that coincided with the use of the medication. This decision by the FDA had unintentionally saved thousands of babies from suffering similar birth defects.

Motivated by the events that occurred from the thalidomide tragedy, The Drug Amendments of 1962 were enacted. Targeting all current medications on the market, as well as those in the pipeline, this law immediately added oversight. It required medications to prove that they were both safe and effective before being approved for use—the first form of REMS.

From here, the idea of a safety strategy for medications with potentially serious risks evolved. In the 1970s, the Controlled Substance Act was adopted and imposed regulations on medications with high abuse potential. Additionally, the Food, Drug & Cosmetic Act was enacted into law and gave way to the birth of the package insert.

Throughout the late 1980s and into the 1990s, certain medications began to adopt safety programs that accompanied their use. The most notable example of this occurred in 1988, when Accutane utilizers were required to satisfy a pregnancy prevention program before each fill.

The idea of REMS took its biggest leap forward in 2004 when the FDA required risk minimization action plans for certain medications with abnormally high risks and benefits associated with use. Medications such as Accutane with the iPledge program and Tracleer with the TAP program were among the first medications subject to increased scrutiny.

The current version of the REMS program came to life in 2007 with the adoption of the Food and Drug Administration Amendments Act. As a result, the FDA was granted with the authority to enhance drug safety measures across the industry, and that is what they did.

Medications that were currently on the market could be subject to requiring a REMS if post-marketing safety concerns arise. Additionally, medications in the approval process would also be subject to the requirement if clinical trials produced serious safety concerns. In either case, the FDA was determined to ensure that certain medications would have an ongoing need to balance the risks versus the benefits.

As a specialty pharmacy and/or a specialty pharmacist, what does REMS mean to you? I hope two obvious thoughts came to mind.

First, we as pharmacies and pharmacists have an obligation to act in the best interest of our patients. If you are counseling a patient on a REMS medication and you neglect to counsel appropriately, no matter what the reason, you have failed to meet your primary obligation.

We know the good, bad, and the ugly that accompany a REMS medication. It is critical that we educate, monitor, continue to educate, and continue to monitor these patients. Not doing an effective job of this is risky business.

The path of risky business can lead to some unfavorable implications for you as the individual, as well as your employer. The manufacturers are watching and the FDA is watching, most likely not in real time, but you get the point.

Therefore, the possibility of an unexpected audit always exists. If you are found to be non-compliant as either the pharmacist or pharmacy, please ensure your checkbook is readily available.

Not sure about you, but this is not a risk that I want to take.

About the Author

Joe Thomas earned his Doctor of Pharmacy degree from Duquesne University and is currently enrolled in the Masters of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. He has spent the past several years working across several specialty pharmacies, integrated in both staff and corporate experiences.

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