RISK EVALUATION AND MITIGATION STRATEGIES

To advocate for research on the impact of the Food and Drug Administration’s Risk Evaluation and Mitigation Strategies (REMS) on patient safety, cost effectiveness, and pharmacy workflow; further,

To advocate pharmacist involvement in the development and implementation of REMS; further,

To urge computer software vendors to assist pharmacists in the identification of and compliance with REMS; further,

To advocate that any REMS that include constraint on traditional drug distribution systems be consistent with ASHP policy on restricted drug distribution. 

Rationale

Risk Evaluation and Mitigation Strategies (REMS) are part of new authority granted to the Food and Drug Administration (FDA) to ensure that a drug’s benefits outweigh its risks. An increasing number of drug products require REMS in order to be marketed, and some REMS require Medication Guides as well as other “elements to assure safe use.” These elements beyond a Medication Guide have included prescriber and pharmacist training, patient registry, and additional patient monitoring. ASHP believes that more research should be conducted by either the FDA or drug manufacturers to determine the effectiveness of and need for REMS. Health-system pharmacists have encountered problems with REMS that were developed without input from health-system pharmacy.  Pharmacist input in the development of REMS is essential to avoid unnecessary barriers to patients and burdensome interruptions to pharmacy workflow that could impact patient care and safety.

Drug information and knowledge vendors providing information technology and decision support systems will need to include gateways to specific information about REMS so that pharmacists and other health professionals have access to information about all REMS-required products and the specific requirements for a particular REMS that includes elements to assure safe use.

Finally, REMS that include constraints on traditional drug distribution systems should be consistent with existing ASHP policy on restricted drug distribution.