New rules for opioid prescribing

New rules for opioid prescribing

The FDA is considering new tightened restrictions on use of opioid drugs. Manufacturers of these drugs will be required to have a Risk Evaluation and Mitigation Strategy to ensure that "the benefits of the drugs continue to outweigh the risks." The affected opioids include fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. This is in response to raising rates of misuse and abuse of these drugs as well as accidental overdoses, which have increased in the last 10 years. The agency plans to have a number of meetings later this year that will include patient groups, federal agencies, and other non-government institutions. Part of the strategy is to make sure that physicians prescribing these products are properly trained in their safe use.

In February, the American Pain Society-American Academy of Pain Medicine Opioids Guidelines Panel published clinical guidelines for the use of chronic opioid therapy and chronic noncancer pain. The guideline was commissioned because of the increased use of chronic opioid therapy for noncancer pain and the high risk for potentially serious harm associated with these drugs including opioid-related adverse effects. The guideline's recommendations include: Before initiating chronic opioid therapy (COT), clinicians should conduct a history, physical, and appropriate testing including assessment of risk for substance abuse, misuse, or addiction. A benefit-to-harm evaluation should be performed and documented before starting COT and on an ongoing basis for all patients on COT. Informed consent should be obtained when initiating therapy, and a continuing discussion with the patient regarding therapy should include goals, expectations, risks, and alternatives. Clinicians may consider a written COT management plan. Patients should be reassessed periodically including monitoring of pain intensity and levels of functioning.

For high-risk patients or those who have engaged in aberrant drug-related behaviors, clinicians should periodically obtain urine drug screens or other information to confirm adherence to the plan of care. For patients at risk of addiction, mental health or addiction specialists should be consulted, and if aberrant drug-related behaviors continue, referral for assistance in management or discontinuation of COT should be considered. The guideline also deals with dose escalations, use of methadone, treatment of opioid-associated adverse effects, cognitive impairment associated with COT that may affect driving and workplace safety, use in pregnancy, and state and federal laws that govern the medical use of COT (J Pain 2009;10:113-130).