As of April 2011, there were over 145 drugs subject to REMS requirements, with that number increasing rapidly. FDA allows the manufacturers of those drugs to create a REMS plan for each drug and individualized processes for the plan's fulfillment; this has led to a lack of standardization of requirements and processes.
Hospitals, as well as their medical staffs and pharmacists, are required to comply with REMS requirements. However, due to the relatively recent development of the REMS initiative, an ever-increasing number of REMS-requiring drugs, and the lack of REMS standardization, hospitals and their administrators often do not have clear guidance on the most feasible strategies to ensure compliance. There is an obvious need for hospitals and health care systems to critically evaluate each drug's REMS requirements and conduct a systematic analysis for the presence of policies and procedures that satisfy those requirements as the first steps in determining REMS compliance.
The purpose of the quality-improvement project described below was to determine the extent of the development and adoption of policies and procedures for REMS compliance at a large academic medical center in order to identify opportunities to improve REMS processes. The medical center is a level I trauma center licensed for 959 acute care beds and 59 rehabilitation beds. At the time of the study, medication orders were written on paper charts, and pharmacists were responsible for order entry; the hospital implemented a computerized prescriber order entry (CPOE) in October 2011.