Risk Evaluation and Mitigation Strategies

Assessment of a Medical Center's Policies and Procedures

Lindsey Childs; Earnest Alexander; Minh-Tri Duong


Am J Health Syst Pharm. 2012;69(10):885-889. 

In This Article

Abstract and Introduction


Purpose The results of a hospital's initiative to evaluate and improve compliance with federally mandated risk evaluation and mitigation strategies (REMS) are presented.
Summary Food and Drug Administration approved REMS plans are required for more than 145 drugs, but clear guidance on strategies for achieving REMS compliance is lacking. As a first step toward determining the extent of REMS compliance at a large medical center, a systematic assessment was conducted to ascertain existing policies and procedures for the use of drugs subject to REMS requirements applicable in the inpatient setting. About 123 drugs with such "inpatient-applicable" REMS requirements were identified; of those, 10 had been ordered by hospital providers during a specified 18-month time frame and were included in the assessment of policies and procedures. The assessment revealed that the hospital lacked a formal REMS policy and had no REMS-compliant procedures in place for 7 evaluated drugs (ambrisentan, buprenorphine–naloxone, darbepoetin alfa, epoetin alfa, oxycodone controlled-release tablets, prasugrel, and pregabalin). Pursuant to the compliance assessment, new procedures to help ensure the safe use of those 7 drugs were developed, and REMS-focused educational programs, order-entry system enhancements, and drug storage modifications were implemented.
Conclusion Quality-improvement initiatives including staff education, incorporation of REMS requirements into existing policy, development of an electronic resource, and creation of a separate storage section for drugs subject to REMS were implemented at a large academic medical center to help ensure compliance with inpatient-applicable REMS requirements.


Medications can cure disease, increase longevity, and improve quality of life, but all medications have adverse effects that can range from a nuisance to potential lethality. For decades, the Food and Drug Administration (FDA) has sought to identify and mitigate the risks associated with medication use. One of the more recent efforts by FDA in this area is the required use of risk evaluation and mitigation strategies (REMS).

Authorization for the REMS initiative was signed into law as a part of the Food and Drug Administration Amendments Act (FDAAA) in September 2007.[1] The creation of the REMS program allows FDA to require and enforce postmarketing surveillance after a drug is approved. During the drug approval process, FDA identifies drugs that may produce serious adverse effects and requires that the manufacturer create a REMS plan for those drugs. Notably, before the passage of the FDAAA, some drugs already were subject to FDA risk minimization action plans or medication guide requirements; since the law's enactment, the manufacturers of those drugs have been permitted to resubmit those plans for approval as REMS plans. Additionally, manufacturers have the option of voluntarily creating REMS for any drug.


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