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An Examination of State and Federal Opioid Analgesic and Continuing Education Policies: 2016–2018

ABSTRACT: Introduction Opioid overdose deaths in the United States have climbed sharply over the past two decades. Simultaneously, increased awareness of inadequately treated chronic pain has resulted in increased opioid analgesic prescribing. The correlation between these two phenomena has led policymakers to posit that they are causally linked, and to implement policy changes supporting safe opioid prescribing. Purpose To evaluate the impact of its Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program, the US Food and Drug Administration (FDA) requested the opioid manufacturers responsible for implementing that program provide information regarding opioid policy changes from 2016 to 2018. FDA also requested a survey of state requirements for pain and opioid prescribing continuing education (CE), the number of prescribers affected by those requirements, the extent to which a REMS-compliant CE program would meet each state’s requirements, and the number of relevant CE programs available. Results Results indicate that 527 federal and state opioid-related policies (statutes, rules/regulations, and guidelines) were approved during the 2016–2018 study period. While the largest number of these policies focused on prescription drug monitoring programs, 170 specifically imposed limits on opioid prescribing and an additional 35 specifically referred to, or incorporated, the Centers for Disease Control and Prevention opioid prescribing guideline. We also found that 46 states and the District of Columbia mandated some amount of pain or opioid prescribing CE for prescribers renewing their licenses. These mandates potentially affected as many as 1.7 million prescribers. In 69% of cases, a REMS-compliant CE program would fully meet the state mandates for various types of prescribers. Conclusion The severity and complexity of the problems of pain management and opioid overdose have led to large-scale intervention by policymakers. Assessing the impact of these changes is difficult, at best, but will be necessary if interventions are to be refined to increase their effectiveness.

SUBMITTER: Duensing K

PROVIDER: S-EPMC7534855 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Project description:ImportanceOpioid-reduction policies have been enacted by US states to address the opioid epidemic. Evidence of an association between policy implementation and decreased rates of pediatric opioid poisoning provides further justification for expanded implementation of these policies.ObjectiveTo examine the association of 3 state-level opioid-reduction policies with the rate of opioid poisoning in children and adolescents.Design, setting, and participantsThis interrupted time series analysis used data from the National Poison Data System (NPDS), a database of poisoning information reported to poison control centers across the US. Individuals younger than 20 years who experienced poisoning associated with 1 or more prescription opioids from January 1, 2005, to November 30, 2017, were included. The analysis focused on 3 widespread policy interventions: the prescription drug monitoring program (PDMP), pain clinic legislation, and opioid prescribing guidelines. Data analysis was performed from January 30, 2020, to March 30, 2020.ExposuresAny opioid poisoning in individuals younger than 20 years that was reported to the NPDS.Main outcomes and measuresOpioid poisoning rates per million person-months before and after implementation of each of the 3 policies, overall and stratified by age (≤4 years, 5-9 years, 10-14 years, and 15-19 years).ResultsA total of 338 476 opioid poisoning incidences in children and young adults were reported to the NPDS within the study period. Of this study population, the mean (SD) age was 9.74 (7.15) years, and 179 011 (52.9%) were female. The implementation of a PDMP was associated with a reduction in the monthly rate of opioid poisoning in children and adolescents (-0.07 per million person-months; 95% CI, -0.09 to -0.04) in the postimplementation period. This reduction was observed for all age groups except for the 10- to 14-year age group (-0.03 per million person-months; 95% CI, -0.05 to 0.00). Pain clinic legislation was associated with an immediate reduction in opioid poisoning (-6.22 per million person-months; 95% CI, -8.98 to -3.47). This association was statistically significant across all ages except for the 4 years or younger group. Analysis of the association of implementation of opioid prescribing guidelines was limited because of insufficient follow-up data and did not show an immediate or monthly change in the rate of opioid poisoning.Conclusions and relevanceResults of this study suggest that certain state-level opioid-reduction policies were associated with decreases in pediatric opioid exposures across age groups. Further examination of the underlying mechanisms of these associations, including age group-specific outcomes, may expand and strengthen policies that reduce opioid poisoning, misuse, and overdoses in children and adolescents.

Project description:PurposeContinuing health provider education (HPE) is an important intervention supported by health policy to counter the opioid epidemic; knowledge regarding appropriate program design and evaluation is lacking. The authors aim to provide a comprehensive understanding of evaluations of opioid-related continuing HPE programs and their appropriateness as interventions to improve population health.MethodIn January 2020, the authors conducted a systematic search of 7 databases, seeking studies of HPE programs on opioid analgesic prescribing and overdose prevention. Reviewers independently screened the titles and abstracts of all studies and then assessed the full texts of all studies potentially eligible for inclusion. The authors extracted a range of data using categories for evaluating complex programs: the use of theory, program purpose, inputs, activities, outputs, outcomes, and industry involvement. Results were reported in a narrative synthesis.ResultsThirty-nine reports on 32 distinct HPE programs met inclusion criteria. Of these 32, 31 (97%) were U.S./Canadian programs and 28 (88%) were reported after 2010. Measurements of changes in knowledge and confidence were common. Performance outcomes were less common and typically self-reported. Most studies (n = 27 [84%]) used concerns of opioid-related harms at the population health level to justify the educational intervention, but only 5 (16%) measured patient- or population-level outcomes directly related to the educational programs. Six programs (19%) had direct or indirect opioid manufacturer involvement.ConclusionsContinuing HPE has been promoted as an important means of addressing population-level opioid-related harms by policymakers and educators, yet published evaluations of HPE programs focusing on opioid analgesics inadequately evaluate patient- or population-level outcomes. Instead, they primarily focus on self-reported performance outcomes. Conceptual models are needed to guide the development and evaluation of continuing HPE programs intended to have population health benefits.

Project description:BackgroundContinuing health professions education (CHPE) is an important policy intervention for the opioid epidemic. Besides effectiveness or impact, health policy implementation should be studied to understand how an intervention was delivered within complex environments. Implementation outcomes can be used to help interpret CHPE effects and impacts, help answer questions of "how" and "why" programs work, and inform transferability. We evaluated Safer Opioid Prescribing (SOP), a national CHPE program, using implementation outcomes of reach, dose, fidelity, and participant responsiveness.MethodsWe conducted a retrospective quantitative implementation evaluation of the 2014-2017 cohorts of SOP. To measure reach and dose, we examined participation and completion data. We used Ontario physician demographic data, including regulatory status with respect to controlled substances, to examine relevant trends. To measure fidelity and participant responsiveness, we analyzed participant-provided evaluations of bias, active learning, and relevance to practice. We used descriptive statistics and measures of association for both continuous and categorical variables. We used logistic regression to determine predictors of workshop participation and analysis of covariance to examine variation in satisfaction across different-sized sessions.ResultsReach: In total, there were 472 unique participants, 84.0% of whom were family physicians. Among Ontario physician participants, 90.0% were family physicians with characteristics representative of province-wide demographics. Dose: Webinar completion rate was 86.2% with no differences in completion based on rurality, gender, or controlled substance prescribing status with medical regulatory authorities. Fidelity and participant responsiveness: Nearly all participants rated the three webinars and workshop as balanced, and each element of SOP was also rated as highly relevant to clinical practice.ConclusionsThis evaluation demonstrates that Safer Opioid Prescribing was implemented as intended. Over a short period and without any external funding, the program reached more than 1% of the Ontario physician workforce. This suggests that the program may be a good model for using virtual CHPE to reach a critical mass of prescribers. This study represents a methodological advance of adapting evaluation methods from health policy and complex interventions for continuing health professions education. Future studies will assess effectiveness and impact on opioid prescribing and utilization within evaluation models of complex interventions.

Project description:BackgroundIn response to the opioid overdose crisis in the United States, many states implemented policies to guide opioid prescribing, but their impact on overdose mortality (prescription and non-prescription) remains poorly understood. We examined the impact of U.S. state opioid-prescribing policies on opioid overdose mortality following implementation.MethodsWe calculated opioid overdose mortality rates from 1999-2016 by U.S. state using the CDC WONDER database, overall and separately for overdose deaths from prescription and non-prescription opioids. For each state, policies active on 1/1/2014 were reviewed for the presence and strength of six provisions recommending judicious opioid prescribing practices; "strong" provisions used the words "should," "shall," or "must". Interrupted time series (ITS) tested the association of each strong provision with overdose mortality, overall and separately for prescription and non-prescription opioids, in the two years following implementation. Sensitivity analyses compared between states, used time-lagged analyses, and excluded synthetic opioids from non-prescription opioid deaths.ResultsAll six provisions had consistent direction of effect in ITS and sensitivity analyses. Strong provisions for prescriber training and limits on opioid dose reduced the slope of overall and prescription opioid overdose mortality in both ITS and sensitivity analyses. Reduced non-prescription opioid overdose mortality was only associated with strong provision for prescriber training. Some provisions had a negative impact. In ITS, strong provision for prescriber response to misuse increased the slope of non-prescription opioid overdose mortality. Strong provision for mandatory prescription drug monitoring program use had no relationship with overdose mortality in ITS and was associated with increased overall, prescription and non-prescription opioid overdose mortality in between-state sensitivity analysis.ConclusionOpioid prescribing policies in U.S. states at the peak of the prescription opioid epidemic had modest mortality benefit, and did not reduce non-prescription opioid overdose mortality. A strong provision for prescriber training was the only provision associated with reduced prescription and non-prescription opioid overdose mortality. These findings can inform future efforts addressing prescription drug epidemics.

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An Examination of State and Federal Opioid Analgesic and Continuing Education Policies: 2016–2018

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