Notice & Comment

The Opioid Addiction Prevention Act and the Best Distribution of Regulatory Activity over Illicit and Prescription Opioids

There is substantial evidence that opioid addiction poses a significant threat to individual and public health in the United States.  The CDC reports that the majority of drug overdose deaths (more than six out of ten) involve an opioid.  Since 1999, the number of overdose deaths involving opioids quadrupled. From 2000 to 2015 more than half a million people died from drug overdoses. 91 Americans die every day from an opioid overdose.

The problem may be divided (among other analytic possibilities) into legal (e.g. prescription) and illicit (e.g. heroin) market sources.  Overdoses from prescription opioids are a driving factor in the 15-year increase in opioid overdose deaths. Since 1999, the amount of prescription opioids sold in the U.S. nearly quadrupled, while there has not been a measurable change in the amount of pain that Americans report. Deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methadone—have more than quadrupled since 1999.

On April 7, John McCain and Kirsten Gillibrand introduced the Opioid Addiction Prevention Act which defines conditions of acute pain and tells physicians how they may prescribe for them.  Under the law, physicians who prescribe opioids would be required to certify, in order to secure registration or renewal of registration under the Controlled Substances Act, that they would, to treat acute pain, not write a prescription for more than a 7-day supply of an opioid.  The bill also prohibits the refill of such prescriptions for acute pain.

The proposed law raises many of the difficulties that accompany federal efforts to influence areas traditionally regulated under state police powers.  “Acute pain” is defined as “pain with abrupt onset and caused by an injury or other process that is not ongoing” and excludes “chronic pain,” “pain treated as part of cancer care,” “hospice or other end-of-life care,” or “pain treated as part of palliative care” from the meaning of “acute pain.”

The bill doesn’t endeavor to assess how much pain a patient must experience for it to be deemed “acute” and it inevitably increases the number of interactions between prescriber and patient – with an unforeseeable effect on practice.  All of this will be introduced at a time when states at the regulatory, professional disciplinary, and civil tort system level are undertaking a number of measures to address the epidemic.  The insertion of federal definitions and standards into prescription behavior does not appear tailored to the strengths or role for federal competency – e.g. networks moving illicitly obtained prescription drugs regionally or nationally – nor does it appear fully cognizant of state-level actions now under way.

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