Gilsenan A, Andrews E, Hollis KA. Characterization of current risk evaluation and mitigation strategies. Poster presented at the 26th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 25, 2010. Brighton, United Kingdom. [abstract] Pharmacoepidemiol Drug Saf. 2010 Aug; 19(S1):S100.

BACKGROUND: The number of REMS approvals has increased over time. At the end of 2009, 91 drugs had an approved REMS and 12 additional drugs had a deemed REMS. While most REMS require a medication guide only and some also require a communication plan, some require elements to assure safe use (ETASU). Per the FDA Amendments Act of 2007, ETASU may include certification of prescribers, certification of dispensers, restricted availability (e.g., hospital only), dispensed to patients only with documentation of safe-use conditions, patient monitoring or a patient registry.

OBJECTIVES: To review characteristics of approved and deemed REMS with ETASU in the US.

METHODS: We identified all drugs recognized by the FDA as having an approved or deemed REMS as of December 31, 2009. We reviewed publicly available information to identify the ETASU, as well as the safety issue prompting the REMS and the primary indication for the products.

RESULTS: A total of 19 currently marketed drugs have ETASU (8 of 91 approved REMS and 11 of 12 deemed REMS). Indications for these drugs were in the following categories: biologic or immunity (n¼5), neurologic (n¼6), cardiovascular (n¼3), gastrointestinal (n¼3), other (n¼2). Safety concerns prompting the REMS included birth defects (n¼5), increased cardiovascular risk (n¼2), liver toxicity (n¼3), hematologic disorder (n¼4), and abuse/diversion (n¼4). Elements of safe use included provider certification (17/19), dispenser certification (13/19), documentation of patient safe-use conditions (19/19), restricted availability (6/19), patient monitoring (4/19), and patient registry (2/19).

CONCLUSIONS: The majority of REMS require only a medication guide. Elements to assure safe use are being used selectively, tailored to the specific product concerns. Provider certification and documentation of patient safe-use conditions are far more common than the other elements, including restricted product availability, patient monitoring or patient registries.

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