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Risk evaluation and mitigation strategies: assessment of a medical center's policies and procedures.

Abstract

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.

Links

  • Publisher Full Text

    • Authors

    Childs L, Alexander E, Duong MT

    Institution

    South Texas Veterans Health Care System, San Antonio, TX 78229, USA. lmchilds000410@gmail.com

    Source

    American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists 69:10 2012 May 15 pg 885-9

    MeSH

    Academic Medical Centers
    Drug Monitoring
    Drug Storage
    Legislation, Drug
    Medication Systems, Hospital
    Pharmacy Service, Hospital
    Policy
    Risk Assessment
    Risk Management
    United States
    United States Food and Drug Administration

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    22555085