Federal rules eased for opioid addiction treatment drug

The White House's drug czar tells participants at the AMA National Advocacy Conference about the administration's latest efforts to curb addiction and overdose of painkillers.

By Charles Fiegl amednews staff — Posted Feb. 25, 2013

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Federal regulators have relaxed restrictions on physicians prescribing the opioid addiction treatment drug buprenorphine to patients.

The rule change offers doctors and opioid treatment programs greater flexibility when dispensing buprenorphine, a drug used to wean patients off opiates. The regulation was discussed along with several other topics by U.S. Office of National Drug Control Policy Director R. Gil Kerlikowske during the American Medical Association's 2013 National Advocacy Conference in Washington on Feb. 13.

In 2011, the White House launched a national plan to take a multifaceted approach toward fighting prescription drug abuse. Kerlikowske, known to many as the White House's drug czar, highlighted the latest efforts to combat drug diversion, boost treatment programs and increase education initiatives.

Americans are prescribed 99% of the hydrocodone manufactured while representing less than 5% of the world's population, AMA Board Chair Steven J. Stack, MD, said while introducing Kerlikowske. “This is a crisis,” Dr. Stack said. “This is an epidemic. We do bear responsibility for a piece and portion of this.”

Kerlikowske said he has found physicians and the AMA as partners committed to working to address the problem. Further input from doctors and other health care professionals is needed, for example, to reduce the prevalence of pill mills and detect doctor shopping.

On the front lines, physicians must remain vigilant when prescribing painkillers and discussing appropriate use of medicines, Kerlikowske said. Americans trust their health care professionals and often are more open to discussing drug problems with their physicians rather than with close relatives. “You have this power to intervene early,” he said.

More patients can take drug home

The Obama administration had recognized federal policy regarding buprenorphine to be too restrictive, Kerlikowske said. The White House announced the final buprenorphine rule in December 2012 and now permits certain programs and physicians to dispense buprenorphine addiction treatment products as take-home medicine without specifying a length of treatment for the patient. The change increases “flexibility in treatment and is justified by the experience to date with buprenorphine addiction treatment products, together with buprenorphine's safety profile,” the rule states.

Federal regulators did warn that there still is a risk of buprenorphine abuse and diversion. However, abuse of the drug appears to be much less compared with other opioids.

The Health and Human Services secretary “will continue to monitor abuse while applying the specific buprenorphine abuse reduction interventions discussed elsewhere in this notice,” the rule stated. “While cognizant of this abuse, the secretary believes that eliminating the time in treatment restrictions for buprenorphine will result in more patients treated in structured opioid treatment programs, where controls and requirements can be applied to identify and address buprenorphine abuse and diversion.”

The Office of National Drug Control Policy has focused on improving prescription drug monitoring programs to break down silos of information and improve interoperability among states, Kerlikowske said. For instance, a physician in eastern Kentucky might need to check three state databases, including Ohio and West Virginia, for patient history when prescribing painkillers.

“Our prescription drug monitoring programs are being vastly improved as a result of the work that you've done … to make them more robust and easier to use,” he said.

Kerlikowske also stressed the importance of training physicians to practice safe opioid prescribing. The AMA offers free training sessions on prescribing opioids and on the public health response to prescription drug abuse. The sessions can be viewed on the AMA's website.

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Drug-related emergency department visits

Statistics show a total of nearly 1.2 million drug-related emergency department visits involving nonmedical use of pharmaceuticals in 2010, the Dept. of Health and Human Services stated in its final rule on dispensing buprenorphine. Officials expressed concern about the possible diversion of buprenorphine, a drug used to treat opioid addicts. However, abuse of the drug is relatively low compared with other painkillers.

Drug ED visits
Oxycodone 146,535
Hydrocodone 95,972
Methadone 65,945
Fentanyl 21,196
Hydromorphone 17,666
Buprenorphine 15,778

Note: Figures include cases in which medications were combined with other drugs.

Source: “Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Proposed Modification of Dispensing Restrictions for Buprenorphine and Buprenorphine Combination as Used in Approved Opioid Treatment Medications,” Dept. of Health and Human Services, Federal Register, Dec. 6, 2012 (link)

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External links

“Prescription Opioid Overdose and the Public Health Response,” American Medical Association webinar, Dec. 12, 2012 (link)

“ '8' Reliable Principles to Safe Opioid Prescribing,” AMA webinar, Nov. 1, 2012 (link)

“Epidemic: Responding to America's Prescription Drug Abuse Crisis,” U.S. Office of National Drug Control Policy, 2011(link)

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