On July 13, 2017, the Board on Health Sciences Policy of the Health and Medicine Division of the National Academies of Sciences Engineering and Medicine (NASEM) issued a report titled “Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use.” The US Food and Drug Administration (FDA) commissioned this comprehensive report to provide an update on current evidence on research, care, and education in the pain field, and to identify actionable measures for the FDA to more adequately address the ongoing opioid epidemic.
The report highlights the fact that “A sustained, coordinated effort is necessary to stem the still-escalating prevalence of opioid-related harms, including a culture change in prescribing for chronic noncancer pain, aggressive regulation of opioids by the FDA, and multi-pronged policies by state and local governments.”
The following are the main strategies and recommendations presented.
Curbing the Opioid Epidemic
1. Restrict the number of prescriptions for opioids
- Measures at the local level to reduce supply may successfully restrict access.
- There is insufficient evidence evaluating the impact of such actions on the well-being of patients with chronic pain.
- Effective programs should be made more widely available through public-private partnerships and include drug take-back programs, which contribute to the safe disposal of opioid medication, as well as efforts to raise awareness on the issue.
2. Influence prescribing practices
- Nonopioid therapies and nonpharmacologic interventions may be as effective as opioids for the management of pain.
- A “culture shift” supported by educational efforts focused on healthcare professionals in the field of pain management is warranted.
- Formulate new evidence-based prescription guidelines and create a national approach to pain education.
- Increase access to nonpharmacologic interventions as part of a comprehensive pain management plan and broaden insurance coverage for such interventions.
- Leverage data available on prescription drug monitoring programs that allow the tracking of opioid prescribing and dispensing as a way to inform policies.
3. Reduce demand
- Educate the general public on the risks and benefits of opioids and the effectiveness of opioids vs nonopioid or nonpharmacologic therapies.
- Broaden the use of medication-assisted treatments for opioid use at the state level and facilitate their coverage by insurance plans.
4. Reduce harm
- Improve access to naloxone through policies, by reducing costs, and by offering it as an option to patients at risk of developing an opioid use disorder along with opioid prescriptions.
FDA Monitoring of Opioids
A system-wide approach should be undertaken by the FDA to weigh the risks and benefits of opioid medications and communicate to patients, their relatives, and the community at large.
The NASEM committee recommends that the FDA:
- Conduct a thorough assessment of the impact of opioid prescribing on public health in order to inform clinical development and the scheduling of opioid-based medications;
- Increase transparency regarding the regulation of opioid medications;
- Tighten post-approval oversight for opioids; and
- Review opioid medications that are on the market or have recently received approval.
Pain Research Needed
The following areas of pain research have been identified by the committee as essential components of the effort to address the opioid epidemic:
- Investigation of the neurobiologic mechanisms of pain, opioid use disorder, and the interactions between the two
- Bridging of the epidemiologic data gap available for pain, opioid use disorders, and other opioid-related harms, as a way to better inform policy
The committee concludes that “Access to evidence-based treatment for [opioid use disorder] should be substantially and immediately increased as a public health priority,” and adds that “Scientifically grounded policies and clinical practices to promote responsible opioid prescribing are needed, along with research to identify and develop nonaddictive alternatives to opioids for treatment of pain,” a process it acknowledges will take a “sustained and coordinated” effort on the road to successfully curbing the opioid epidemic in the United States.
Bonnie RJ, Ford MA, Phillips JK. Committee on Pain Management and Regulatory Strategies to Address Opioid Abuse; Board on Health Sciences Policy; Health and Medicine Division; National Academies of Sciences, Engineering, and Medicine. Pain management and the opioid epidemic: balancing societal and individual benefits and risks of prescription opioid use. July 12, 2017. Available at: https://www.nap.edu/download/24781#. Accessed July 13, 2017