Risk Evaluation and Mitigation Strategies in Specialty Pharmacy


Specialty pharmacy stakeholders continue to balances benefits versus risks with new specialty drug products.

Safety for all patients is expected and demanded in all areas of health care, anything less would be met with deafening outcries for intervention and reform. As science and technology have evolved, so has the need for evaluating the risks versus benefits of new discoveries in health care.

This is especially true as it relates to drugs. The FDA has a lead role in drug and patient safety.

In the last 30 years, the FDA has created multiple programs to protect patients at all stages of a drug product life cycle. Programs such as MedWatch and the Adverse Event Reporting System were put in place to collect information after the prescription drug was approved and on the market.

The FDA included over-the-counter drug products in their scope as well. The requirement for a Drug Fact Label to appear on every over-the-counter drug product was done to provide the consumer with the information needed to make an educated decision about the benefits versus risks associated with the product.

In the early 2000s, two widely used prescription products, one for cholesterol and the other an NSAID for pain relief, were pulled from the market due to post-market reports of serious risks. The reported risk of severe muscle-wasting from the cholesterol product, and an increased risk of heart attacks and strokes attributed to the NSAID, were traced back to these respective products after years of being on the market.

Shortly after the two aforementioned products were removed from the market, the FDA rolled out the Risk Minimization Action Plans (RiskMAP). RiskMAP was a strategic safety program designed to meet specific goals and objectives in minimizing known risks of a product while preserving its benefits.1

RiskMAPs were becoming part of the new drug approval process, to allow products with known risks to come to market, as long as there was education and awareness about the risks and benefits of the drug therapy. A solid first attempt, but more rigor was needed to support new products, such as the biologics developed for diseases that once had no treatment options.

The RiskMAP program was the forerunner of today’s REMS program. REMS is an acronym for Risk Evaluation and Mitigation Strategies program, which is a result of the passing of the Food and Drug Administration Amendments Act (FDAAA) by Congress in September 2007.2

The approval of the FDAAA gave the legal support and resources needed to impact drug safety issues through early detection and evaluation of data after a drug is on the market.3 The need to monitor and collect data for patient safety evaluation, even once approved to enter the market, is what the REMS program allowed.

It provided opportunity for the newest drugs to reach those in greatest need quickly, while maintaining a safety net as a result of the REMS program. Once REMS was the approved program for minimizing risk and improved patient safety, 16 products with a RiskMAP were transitioned to a REMS design.

An additional Congressional act related to REMS was enacted in July 2012 to make improvements to the program. The act responsible for the enhancements to REMS is known as the Food and Drug Administration Safety and Innovation Act. Since this act went into effect, some products have had the REMS removed or changed to a less stringent protocol since the data collection over time proved the long-term safety of the product.

The FDA continues to evaluate the REMS program, and provides opportunity for feedback to improve the program, ensuring it does not become an unnecessary burden to the health care system. The costs and time associated with the REMS of a product must be balanced and not overwhelm one party (the pharmacy or manufacturer), in order to allow patients continuous access to the product.

As of 2016, the REMS programs are still delivering patient and public safety with novel drug launches; however, some brand name drug manufacturers are trying to use the limited distribution component of certain REMS requirements as a competitive advantage. The Federal Trade Commission has expressed concern over the REMS program being anti-competitive when there is a limited distribution requirement.

The brand name manufacturer uses the REMS requirement avoid providing a product to a generic manufacturer, stating the product can only be provided via the limitations of the distribution model. The request for product by the generic manufacturer is for the purpose of developing and testing a generic or biosimilar concept of the brand name product.

The Hatch Waxman Act in 1984 encourages generic formulations; however, certain REMS protocols created a loophole that is being used to the benefit of the brand name drug manufacturer and their investors. A Congressional bill, the Fair Access to Safety and Timely Generics Act, was introduced this year to end the REMS loopholes, which are impeding generic competition.6

The focus on health care spending, and the need for safe and effective alternative drug choices is a daily conversation for many groups. It is a matter of time until another revision of the REMS model occurs.

What must remain is the REMS program, as it has advanced patient safety, while allowing novel drug molecules on the market to treat patients with few, if any, treatment options a decade ago.

The REMS program is a necessary drug safety program, and should remain in place for both the brand name products and any generic or biosimilar products that gain FDA approval in the future.

About the Author

Jill Schachte earned her BS in Pharmacy 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. Jill has spent the past 20 years working in specialty pharmacy, starting as a clinical pharmacist with Stadtlanders Pharmacy and working in a variety of a management roles in specialty pharmacy operations for CVS Health. Jill’s current role is on the CVS Specialty Professional Practice team with a focus on accreditation and compliance for all the specialty pharmacy locations within CVS Health.


  • http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126830.pdf

Guidance for Industry Development and Use of Risk Minimization Action Plans.

U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) March 2005 Clinical Medical

  • http://www.drugprotections.org/index.php/understanding-rems/history/
  • http://www.fda.gov/downloads/Drugs/DrugSafety/UCM300946.pdf

Advances in FDA’s Safety Program for Marketed Drugs Establishing Premarket Safety Review and Marketed Drug Safety as Equal Priorities at FDA’s Center for Drug Evaluation and Research…. from the April 2012 Drug Safety Report published by the FDA.

  • http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM107976.pdf
  • http://thehill.com/blogs/congress-blog/healthcare/276494-strengthening-rems-for-patient-safety-and-faster-access-to
  • http://thehill.com/blogs/congress-blog/healthcare/267900-generic-drugs-drive-savings-not-costs

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