Requirements for Drug Manufacturers Regarding Prescriber Education

Description

The requirements for drug manufacturers regarding prescriber education, decreed by the U.S. Food and Drug Administration (FDA), were established to fund the development and dissemination of specific educational materials on extended-release and long-acting (ER/LA) opioids, including materials for prescribers and patients, and to conduct ongoing assessment of the reach and effectiveness of these efforts.

Objective(s)

To enhance patients'; and providers'; understanding of the risks associated with misuse of opioids and to increase providers'; knowledge of appropriate prescribing practices for such drugs

Typical Elements

  • The FDA-implemented Risk Evaluation and Mitigation Strategy for ER/LA opioids requires drug manufacturers to support prescriber education programs (FDA, 2014; Gudin, 2012). Prescriber opioid education seeks to reduce opioid abuse or overdose while maintaining legitimate and appropriate access to pain management drugs (FDA, 2013).
  • Two manufacturer-produced documents are required for each approved opioid (FDA, 2013, 2014):
    • A one-page Medication Guide that identifies important information about the drug';s known and potential risks (U.S. Department of Health and Human Services, 2013). A paper version of the guide must be given to each patient who receives the drug. An Internet version of the guide must be made available to patients and healthcare providers.
    • A Communication Plan, which the manufacturer sends to healthcare providers (including prescribers, dispensers, state licensing authorities, professional associations, and all other U.S. Drug Enforcement Administration registrants) within 60 days of drug approval. The plan includes a "Dear Healthcare Provider Letter" that explains the drug';s risks (FDA, 2014, p. 4).
  • The FDA requires prescription drug manufacturers to create and offer independent, voluntary ER/LA opioid training programs for healthcare providers through educational grants to accredited continuing medical education (CME) providers (FDA, 2014).
    • Manufacturers must work with CME accrediting bodies to ensure that the trainings are appropriate to prescribers'; medical specialties (FDA, 2014) and that they fulfill any state CME requirements for pain management licensure (American College of Emergency Physicians, 2013).
    • A "post-course knowledge assessment" is required (FDA, 2013, p. 26).
    • Training can be independently audited to confirm that the required conditions have been met (FDA, 2013).
      • Note: The FDA does not have authority to regulate physicians or other healthcare providers and cannot require them to participate in a training program.
  • The FDA recommends that education programs, sponsored by manufacturers, address the following issues (FDA, 2014; Gregory, 2013):
    • Assessing patients'; opioid abuse potential by completing a physical examination and all other appropriate documentation, and using opioid risk assessment tools (e.g., the Opioid Risk Tool; Diagnosis, Intractability, Risk, Efficacy; and Screener and Opioid Assessment for Patients with Pain-Revised)
    • How to initiate and discontinue opioid use and modify ongoing prescriptions
    • How to appropriately oversee opioid use, including setting, discussing, and evaluating treatment goals with patients, and when and how to use drug testing
    • How to counsel patients and caregivers about safe opioid use
    • General and specific information about drug characteristics, toxicities, and interactions
      • Note: The FDA has the authority to reject a manufacturer';s training program if the training is biased toward the manufacturer';s drug.

Populations

Prescribers of opioids, individuals with opioid prescriptions

Outcomes

Though not specific to opioids, a meta-analysis of CMEs found the following (Cervero & Gaines, 2014):

  • 79% of studied CMEs were effective at improving clinical knowledge, while 42% were effective at improving patient outcomes
  • Interactive CMEs can be more effective than didactic CMEs, although the sample size was too small to draw any definitive conclusions

Guidelines

Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS). 

Introduction for the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics.

Acknowledged by

Food and Drug Administration. Extended Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS).

Office of National Drug Control Policy, Executive Office of the President. Epidemic: Responding to America's Prescription Drug Abuse Crisis.

References

American College of Emergency Physicians. (2013). Continuing medical education for licensure reregistration. Retrieved from https://www.americanseminar.com/ckfinder/userfiles/files/continuing-medical-education-licensure(1).pdf

Cervero, R., & Gaines, J. (2014). Effectiveness of continuing medical education: Updated synthesis of systematic reviews. Retrieved from http://www.accme.org/sites/default/files/2014_Effectiveness_of_Continuing_Medical_Education_Cervero_and_Gaines_0.pdf

Gregory, T. B. (2013). How to safely prescribe long-acting opioids. Journal of Family Practice, 62(Supp12), S12–S18.

Gudin, J. A. (2012). The changing landscape of opioid prescribing: Long-acting and extended-release opioid class-wide Risk Evaluation and Mitigation Strategy. Therapeutics and Clinical Risk Management, 8, 209–217. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3346202/

U.S. Department of Health and Human Services. (2013). Addressing prescription drug abuse in the United States: Current activities and future opportunities. Behavioral Health Coordinating Committee, Prescription Drug Abuse Subcommittee. Retrieved from https://www.cdc.gov/drugoverdose/pdf/HHS_Prescription_Drug_Abuse_Report_09.2013.pdf

U.S. Food and Drug Administration. (2013). Extended-release (ER) and long-acting (LA) opioid analgesics Risk Evaluation and Mitigation Strategy (REMS). Retrieved from https://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf

U.S. Food and Drug Administration. (2014). Introduction for the FDA blueprint for prescriber education for extended-release and long-acting opioid analgesics. Retrieved from http://media01.commpartners.com/ASAM/jul29/ERLAREMSBlueprint.pdf