An Examination of State and Federal Opioid Analgesic and Continuing Education Policies: 2016-2018.
Level 4 - case-series / case-control
Level 4 by design analogy; descriptive cross-sectional audit and surveillance of state and federal policies.
PubMed 33061558 · doi:10.2147/JPR.S267448
What was done
Researchers conducted a policy surveillance review requested by the US Food and Drug Administration (FDA) to evaluate its Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program. The study audited US federal and state opioid-related statutes, regulations, and guidelines enacted between 2016 and 2018, surveyed state-mandated continuing education (CE) requirements for pain and opioid prescribing, estimated the number of affected prescribers, and evaluated whether REMS-compliant CE met individual state requirements.
What was found
A total of 527 federal and state opioid-related policies were approved between 2016 and 2018. The majority targeted prescription drug monitoring programs (PDMPs), while 170 policies placed direct restrictions on opioid prescribing and 35 incorporated CDC opioid prescribing guidelines. Mandatory pain or opioid CE was required for license renewal in 46 states and the District of Columbia, impacting up to 1.7 million prescribers. An FDA REMS-compliant CE curriculum fully satisfied state CE requirements in 69% of cases.
Why it matters
This study quantifies the rapid expansion of US legislative and regulatory restrictions on opioid prescribing following the 2016 CDC guidelines. Demonstrating that FDA REMS CE meets 69% of state educational requirements highlights opportunities to standardize prescriber education across jurisdictions.
Limits
The abstract reports descriptive counts and does not evaluate whether these policy changes reduced opioid-related mortality, lowered prescribing rates, or adversely affected pain management outcomes. The analysis was conducted at the request of opioid manufacturers as part of an FDA regulatory requirement.
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