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Risk Evaluation and Mitigation Strategy (REMS) for Extended-release & Long-acting (ER/LA) Opioids

All prescription drug products carry risks, particularly if they are not prescribed or used appropriately. In some cases, the U.S. Food & Drug Administration (FDA) may decide that a specific drug must have a Risk Evaluation and Mitigation Strategy (REMS) to help ensure that the benefits of the drug outweigh its risks.

A REMS is a program consisting of several components that are developed by the medication’s manufacturer and approved by the FDA. The REMS components are directed toward prescribers, pharmacists, or patients and caregivers to support the safe use of the product. The mandatory component of all REMS includes assessments to determine if it is meeting its intended goals.

The FDA is requiring opioid analgesic companies to implement a new single, shared REMS for all extended-release and long-acting opioid pain medications to ensure that the benefits continue to outweigh the risks of adverse effects resulting from inappropriate prescribing, abuse, and misuse. The principal components of this REMS are:

  • prescriber training on all ER/LA opioid analgesics,
  • a Patient Counseling Document on Extended-Release and Long-Acting Opioid Analgesics (PCD), and
  • a Medication Guide for each ER/LA opioid analgesic drug product.

These components are intended to help healthcare professionals better understand the risks and benefits of selecting and prescribing these important medicines, and to educate patients about how to use as directed, their risks, and proper storage and disposal.

Purdue Pharma L.P. is a member of the REMS Program Companies (RPC), a consortium of pharmaceutical companies that was formed to create the shared REMS for extended-release and long-acting opioid analgesics approved by FDA.

Prescriber training that complies with the criteria specified by FDA for this REMS will be conducted by accredited providers of independent, continuing education. Purdue, as a member of this REMS program, will be contributing to a fund to be disbursed by the RPC via a grant process to accredited continuing education providers. To learn more visit the RPC’s web site at www.ER-LA-opioidREMS.com or the FDA REMS web page at: www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor

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