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Recent Federal Guideline and Marketing Changes in Opioid Prescription Policy

Larochelle et al. (2016) published research on 2,848 commercially insured patients, with ages between 18 and 64 years, who sustained a nonfatal opioid overdose during long-term opioid therapy for non-cancer pain between May 2000 and December 2012. Patients were followed over a median time interval of 299 days. Physicians re-dispensed opioids to 91% of patients after they had made a potentially fatal overdose. Two hundred and twelve patients had a second or third opioid overdose after being prescribed more opioids. After two years follow-up, the repeated overdose rate was 17% for patients receiving high doses of opioids after the index overdose.

One just can’t make this stuff up. Unbelievably, almost all patients continued to obtain prescription opioids from their clinicians after they had made a potentially fatal overdose. This article further noted that research demonstrates that after an overdose, opioid discontinuation reduces risk for repeated overdoses.

With regard to Kentucky, in 2013, there were 1,019 resident drug overdose deaths. This was a slight decrease from the prior high point in 2012. This placed Kentucky second among all states in our country for resident age-adjusted drug overdose death due to opioids (23.7/100,000). Of the more than 1,000 opioid overdose deaths, pharmaceutical opioids remained the primary cause of death, according to medical examiners. In 2013, pharmaceutical opioids were causally involved in 438 drug overdose deaths in Kentucky. Kentucky overdose deaths now exceed motor vehicle crashes as a cause of death from unnatural factors. In the 2011 to 2013 interval, the following Kentucky counties experienced the highest number of overdose deaths involving pharmaceutical opioids per 100,000 county residents: Bell, Clay, Floyd, Johnson, and Knox (Slavova et al. 2015).

Within the last two months, two federal agencies have stepped up changes in guidelines for both treatment and marketing of opioids for chronic pain. In March 2016, the CDC published guidelines for prescribing opioids for chronic pain in the United States (C.D.C. 2016) These guidelines are CDC recommendations for prescribing opioids for chronic pain outside of active cancer, palliative, and end-of-life care. The following 12 guideline points are a summary of the entire CDC recommendations:

1. Non-pharmacologic therapy and non-opioid pharmacologic therapy are preferred for chronic pain.

2. Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how therapy will be discontinued if benefits do not outweigh the risk.

3. 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.

4. When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended release, long-acting opioids.

5. When opioids are started, clinicians should prescribe the lowest effective dose.

6. 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.

7. Clinicians should evaluate benefits and harms with patients within one to four weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every three months or more frequently.

8. Before starting, and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms.

9. Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring programs (PDMPs) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose.

10. When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications, as well as other controlled prescription drugs and illicit drugs.

11. Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.

12. Clinicians should offer or arranged evidenced-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patient with opioid use disorder.

The Food and Drug Administration (FDA), in February 2016, published, A Proactive Response to Prescription Opioid Abuse (Califf et al. 2016). FDA policy is being revised immediately to respond to prescription opioid abuse by examining and promulgating regulations and guidelines for the following issues:

1. Balancing individual need and societal risk,
2. Meeting the need for timely action,
3. Reviewing labeling and post-marketing surveillance requirements,
4. Prioritizing abuse-deterrent formulations and overdose treatments,
5. Addressing the lack of non-opioid alternatives for pain management,
6. Creating clear guidelines for opioid use,
7. Managing pain in children, and
8. Developing a better evidence base.

It is hoped that Kentucky physicians will meet the challenge of modifying opioid prescription practices in Kentucky and increase their level of awareness by reviewing guidelines for opioid use and incorporating them into practice for the chronic pain patient. Moreover, medical schools, residencies and fellowship programs, should incorporate clear evidence-based curricula to teach the biological ramifications of acute versus chronic pain. All medical students, residents and fellows should be provided with up-to-date and evidence-based curricula to inform them of the contemporary management of chronic pain utilizing non-opioid treatments whenever possible.

References:

Califf, R.M., Woodcock, J., Ostroff, S. (2016). A proactive response to prescription opioid abuse. N.Eng. J. Med. Epub ahead of print February 4, 2016. DOI: 10.1056/NEJMsr1601307

C.D.C. (2016). CDC guideline for prescribing opioids for chronic pain: United States, 2016. MMWR 65; 1-37.

Larochelle, M.R., Liebschutz, J.M., Zhang, F., et al, (2016). Opioid prescribing after nonfatal overdose and association with repeated overdose: a cohort study. Ann. Int. Med. 264: 1-9.

Slavova, S., Bunn, T.L., Gao, W. (2015). Drug overdose deaths in Kentucky, 2013. Lexington, KY: Kentucky Injury Prevention and Research Center.

By Robert P. Granacher, Jr., M.D., M.B.A.

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