An Overview of Guidelines and Resources Available
Drug overdoses are the No. 1 cause of accidental deaths in the U.S., surpassing deaths by motor vehicle accidents. Many drug overdose deaths involve prescription medications, predominantly opioids. Even greater by orders of magnitude are those patients and their families affected by opioid dependence and addiction.
Guidance strategies to combat this epidemic are now being endorsed by many large public agencies. In this article, we review guidance from the Centers for Disease Control and Prevention (CDC) and the Federal Drug Administration (FDA). These share common themes in their recommendations.
Published in March 2016, the “CDC Guideline for Prescribing Opioids for Chronic Pain” report is directed at primary care physicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care. However, the report has recommendations relevant to all prescribers of opioids with extensive analysis of the evidence related to:
- When to initiate or continue opioids for chronic pain
- Opioids selection, dosage, duration follow-up and discontinuation
- Assessing risk and addressing harms of opioids use
MagMutual suggests that all opioid prescribers review the entirety of the report, but we emphasize the following 12 recommendations (note that items 4, 6, and 11 apply to all prescribers of opioids, even short-term):
- Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain, and clinicians should consider opioid therapy only if benefits for pain and function outweigh risks.
- Before starting opioid therapy for chronic pain, clinicians should establish treatment goals, including realistic goals for pain and function, and consider how opioids therapy will be discontinued.
- Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy, and patient and clinician responsibilities for managing therapy.
- When starting opioid therapy, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting opioids.
- Clinicians should prescribe the lowest effective dosage, and should carefully reassess evidence of benefits and risks when increasing to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day.
- Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.
- Clinicians should evaluate benefits and harms within one to four weeks of starting opioid therapy or escalating dose, and should evaluate benefits and harms of continued therapy with patients every three months or more frequently.
- Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms, such as sleep apnea, pregnancy, renal or hepatic insufficiency, patients over the age of 65, mental health conditions, substance use disorder and/or prior overdose. Risk mitigation includes offering naloxone especially when there is a history of overdose, history of substance use disorder, opioid dosages ≥50 MME/day, or concurrent benzodiazepine use.
- Clinicians should review the prescription drug monitoring program (PDMP) when starting opioid therapy and periodically, ranging from every prescription to every three months.
- Clinicians should use urine drug testing (UDT) before starting opioid therapy and consider UDT at least annually.
- Clinicians should avoid prescribing opioids and benzodiazepines concurrently whenever possible.
- Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for opioid use disorder.
Link for the full CDC report: http://goo.gl/I629u9
In February 2016, the FDA released “A Proactive Response to Prescription Opioid Abuse,” which was published as a special report for the New England Journal of Medicine. It notes that the number of annual opioid prescriptions in the U.S. is now roughly equal to the number of adults in the population, hence the need to work more closely with key federal agencies and clinical and prescriber communities. The FDA also released a fact sheet about its Opioids Action Plan, which includes the following elements:
- Expand use of advisory committees. The FDA will convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties. The Pediatric Advisory Committee will make recommendations regarding a framework for pediatric opioid labeling before any new labeling is approved. The FDA will consult an advisory committee on abuse-deterrent formulation (ADF) opioids when they raise novel issues.
- Develop warnings and safety information for immediate-release (IR) opioid labeling. The FDA is developing changes to IR opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting (ER/LA) opioid analgesics labeling update that occurred in 2013.
- Strengthen postmarket requirements. Because the evidence base to guide the use of opioid medications, particularly in the setting of long-term use, is substantially lacking, the FDA is strengthening the requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids.
- Update Risk Evaluation and Mitigation Strategy (REMS) Program. ER/LA opioids are currently subject to a REMS program that requires sponsors to fund continuing medical education (CME) providers to offer, at low or no cost, CME courses on the appropriate use of these products. The FDA will update the REMS program requirements for opioids after considering advisory committee recommendations and review of existing requirements.
- Expand access to abuse-deterrent formulations (ADFs) to discourage abuse. The pharmaceutical industry has shown significant interest in developing ADFs and the technology is progressing rapidly. ADFs hold promise as their abuse-deterrent qualities continue to improve and as they become more widely available. The FDA will issue draft guidance with its recommendations for the approval standards for generic abuse-deterrent formulations. Release of this guidance is a high priority, since the availability of less costly generic products should accelerate prescribers’ uptake of ADFs.
- Support better treatment. The FDA is reviewing options, including over-the-counter availability, to make naloxone more accessible to treat opioid overdose, building on the agency’s recent approval of intranasal naloxone. The agency actively supports the Centers for Disease Control and Prevention guidelines for prescribing opioids for the treatment of pain and will facilitate the development of evidence and improved treatments.
- Reassess the risk-benefit approval framework for opioid use. The FDA will seek advice from the agency’s Science Board in March 2016 and is already engaging the National Academy of Medicine on how to take into account our evolving understanding of the risks of opioids, not only to the patient but also the risks of misuse by other persons who obtain them. These reports will be publicly available.
Link to NEJM special report: http://goo.gl/pMFA7K
Link to FDA Opioids Action Plan Fact Sheet: http://goo.gl/D1HN6K