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.
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.