Ensured Patient Safety With REMS Expertise

Jul 26, 2013
The FDA requires Risk Evaluation & Mitigation Strategies (REMS) for certain prescription drugs. Express Scripts has expertise in adhering to REMS programs.

For certain prescription drugs, the Food and Drug Administration requires Risk Evaluation and Mitigation Strategies – or REMS – to ensure the benefits of the product outweigh its risks. REMS can vary widely in levels of complexity, ranging from a simple package insert or medication guide to much more robust programs that may include a communication plan, patient registry and patient monitoring.

The REMS system is designed to ensure patient safety and it works. The additional safeguards provided by REMS have allowed approval of drugs that might not have otherwise been approved and are key to preventing patient adverse events. Steps can be taken to improve the ease and workability of these programs, but those changes must not have a negative impact on patient safety.

Providing REMS Expertise

Express Scripts and our specialty pharmacy, Accredo, dispense 81 of the 88 REMS drugs on the market. Among these, 27 require Elements to Assure Safe Use (ETASU), a complex pharmacy-level process. In addition, United BioSource Corporation, an Express Scripts company, has designed and implemented many of the industry’s largest and most complex REMS programs. We have significant expertise in both assisting pharmaceutical companies and adhering to REMS programs.

Our Recommendation to the FDA

As the FDA investigates potential changes to the program, we suggest greater standardization of the process. Each drug is different and requires different specific protocols. However, establishing general standards for the overall REMS designs – such as defining what level of risk would require a patient registry versus physician training – would speed the approval process and provide a more consistent level of REMS protocol across drugs with similar safety profiles.

We suggest the following:

Look Beyond the Physician. Express Scripts has specialist pharmacists and nurses with disease-specific expertise who provide important clinical counseling to patients. These clinical specialists provide medication-related advice to thousands of patients daily. REMS programs can benefit from such expertise. The FDA should encourage pharmaceutical companies to look beyond the physician’s office and include specialists in support roles like those within our specialized disease states when developing patient educational components.

Foster Improved Patient Access. When access is mentioned within the industry, it often refers to pharmacy access, which is simply the number of pharmacies who inventory a drug. We believe what is really important is patient access, which is more often a function of a pharmacy’s ability to navigate insurance coverage, prior authorizations and proper administration of safety protocols. Pharmaceutical companies should be encouraged to do more to provide education to physicians and pharmacists about how to help their patients gain access to their medications through qualified pharmacies, as well as establishing patient HUBS when necessary to help manage the process.

Require Early, Better Monitoring. The FDA should require early and better monitoring of REMS for effectiveness. In recent years the level of required monitoring has declined. We believe there should be more vigorous, early monitoring conducted in a scientific manner, and those findings should then be used to make improvements to the current program.

You also can learn more about standardizing and evaluating REMS at the FDA’s public meeting this week in person or online.

Author Bio

Bill Martin
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