Methods for Evaluating the Opioid Analgesic Risk Evaluation and Mitigation Strategy [open pdf - 3MB]
From the Overview: "The Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS), required by the Food and Drug Administration (FDA) and implemented by the manufacturers of opioid analgesics intended for use in an outpatient setting, is one strategy among multiple national and state efforts to reduce the risk of abuse, misuse, addiction, overdose, and deaths caused by prescription opioid analgesics. The primary component of this risk evaluation and mitigation strategy (REMS) is a voluntary education program for prescribers, nurses, pharmacists, and other health care providers involved in the treatment or monitoring of patients with pain. A consortium of manufacturers, known as the REMS Program Companies (RPC), conducts annual assessments of the OA REMS and provides summaries of data that are used to determine whether the REMS is meeting its risk mitigation goals."
U.S. Food and Drug Administration: https://www.fda.gov/