A Cochrane review of oral naltrexone for OUD found that the drug was no better than placebo but concluded that available evidence does not allow an adequate evaluation.27 Opioid antagonists may be of value to patients who do not want to take agonists or partial agonists. Extended-release naltrexone also is available to treat OUD.
See the Box below that details steps the FDA and others have taken to prevent POUD and Table 5 for precautions to incorporate when prescribing opioids long-term.
The FDA has moved toward a risk evaluation and mitigation strategy (REMS) for opioids prescribed for pain that requires clinicians to receive training and certification in prescribing opioids for pain as well as identifying and reducing the risk for prescription opioid use disorder (POUD).a In 2011, the Obama administration developed an action plan to better address prescription drug abuse that required several federal agencies to develop programs and policies to address this growing problem; this plan was updated for 2012 (the complete National Drug Control Strategy 2012 is available at www.whitehouse.gov/sites/default/files/ondcp/2012_ndcs.pdf). The American Society of Addiction Medicine has issued a public policy statement that supports the federal approach and outlines other means to reduce POUD.b
Some pain specialists recommend requiring patients to sign an Opioid Pain Management Agreement that includes an “exit strategy” before the first opioid prescription is written. These agreements incorporate elements of “universal precautions” to take when prescribing opioids long term.c,d Although not well-studied, prescribing agreements may help educate patients and providers on how to interact in the management of pain with opioids in a way that is objective and empathic, and may reduce POUD risk.
References
- U.S. Department of Health and Human Services. U.S. Food and Drug Administration. Opioid drugs and risk evaluation and mitigation strategies (REMS). http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm163647.htm. Updated April 5, 2012. Accessed June 28, 2012.
- American Society of Addiction Medicine. Measures to counteract prescription drug diversion, misuse and addiction. http://www.asam.org/advocacy/find-a-policy-statement/view-policy-statement/public-policy-statements/2012/01/26/measures-to-counteract-prescription-drug-diversion-misuse-and-addiction. Published January 25, 2012. Accessed June 20, 2012.
- Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005;6(2):107-112.
- Gourlay DL, Heit HA. Universal precautions revisited: managing the inherited pain patient. Pain Med. 2009; 10(suppl 2):S115-S123.
Table 5
Universal precautions with chronic opioid management
Goals of therapy: partial pain relief and improvement in physical, emotional, and/or social functioning |
Requirement for a single prescribing provider or treatment team |
Limitation on dose and number of prescribed medications |
Prohibition of changing dosage without discussion with the provider first |
Monitoring patient adherence; discuss the use of ‘pill counts’ |
Prohibition of use with alcohol, other sedating medications, or illegal drugs without discussion with the provider |
Agreement not to drive or operate heavy machinery until abatement of medication-related drowsiness |
Responsibility to keep medication safe and secure |
Prohibition of selling, lending, sharing, or giving medication to others |
Limitations on refills—only by appointment, in person, and no extra refills for running out early |
Compliance with all components of overall treatment plan (including consultations and referrals) |
Biological testing to screen for drugs of abuse or alcohol as well as to confirm the presence of prescribed opioids |
Adverse effects and safety issues, such as the risk of physical dependence and addiction behaviors |
The option of sharing information with family members and other providers, as necessary, with the patient’s consent |
Need for periodic reevaluation of treatment |
Reasons for stopping opioid therapy |
Consequences of nonadherence with the treatment agreement |
Source: Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005;6(2):107-112. |
CASE CONTINUED: A closer evaluation
After expressing your appreciation for Mr. H’s kind words and empathy for his chronic pain, you redirect him to his PCP. You ask him to sign a release of information so you and his other clinicians can coordinate his care. When discussing Mr. H with his PCP, you learn the patient has made limited requests for early refills and dose escalation primarily in relation to inadequate pain control and function, has genuine pain pathology, and is greatly distressed over his inability to work. No other AMTBs are present, and a check of the state prescribing database reveals that Mr. H did receive a small quantity of opioids from an ED on 1 occasion.
You and Mr. H’s PCP agree this is “pseudo-addiction” but want to watch Mr. H more closely and look for ways to coordinate his care. The PCP agrees to implement a prescribing agreement, start drug testing (including for the prescribed opioids), and reassess maximizing Mr. H’s function and pain management while you address his combined pain, depression, insomnia, and tobacco use.