BACKGROUND: Overprescription of opioids has fueled an epidemic of addiction and overdose deaths. The FDA required manufacturers of extended-release/long-acting (ER/LA) opioids to fund continuing medical education (CME) on opioids as part of a Risk Evaluation and Mitigation Strategy (REMS).
OBJECTIVES: We sought to determine whether industry-funded REMS on long-acting opioids were consistent with the FDA’s goal to reduce serious, adverse outcomes resulting from inappropriate prescribing, misuse, and abuse.
STUDY DESIGN: In 2018, we analyzed all internet-based REMS CME activities funded by the REMS Program Companies (RPC), a consortium of ER/LA opioid manufacturers.
METHODS: We utilized systematic narrative thematic analysis, an inductive approach that allows for mapping of concepts and meanings across a body of data by identifying, recording, analyzing, and refining key narrative points, called “themes”. Authors viewed all REMS activities multiple times.
RESULTS: Ten themes were identified, all of which were at least somewhat incongruent with federal guidelines and their goals:
1. Chronic pain is a common, under-treated problem.
2. Chronic pain is a chronic disease.
3. Opioids are an appropriate treatment for chronic pain.
4. ER/LAs are more appropriate than immediate-release (IR) opioids for chronic pain.
5. Tolerance is normal, expected, and beneficial.
6. “Opioid rotation” can maximize analgesia and minimize adverse effects.
7. There is no population for whom opioids are absolutely contraindicated or inappropriate.
8. Screening and monitoring tools are effective for preventing opioid-related problems.
9. Opioid related adverse effects, such as respiratory depression and addiction, are due only to misuse and abuse.
10. Addiction, overdose, and death are due to street drugs such as heroin and fentanyl, not prescription opioids.
Themes and statements repeated in these activities were inconsistent with current medical knowledge, evidence-based federal guidelines, and FDA goals.
LIMITATIONS: We evaluated only online, not live, CME. We also did not evaluate individual conflicts of interest of faculty.
CONCLUSIONS: Industry-funded REMS-compliant CME on opioids contain messages that misrepresent scientific evidence and may foster overprescribing of opioids.
KEY WORDS: Opioids, REMS, continuing medical education, pharmaceutical industry, marketing messages, prescribing behavior, chronic pain, addiction
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