NEW TO WHO? –

July 18, 2022 – At the federal level, methadone, which has been prescribed for more than 40 years, is the most regulated drug in the country. There are strict guidelines on who can prescribe it (general practitioners cannot), the clinics that are allowed to use it, medication storage, counseling, urine testing and staffing. Only Substance Abuse and Mental Health Services Administration-certified opioid treatment programs can dispense methadone for OUD, and most states impose further restrictions on clinic locations, testing and patient medication pickup schedules.

Although buprenorphine, which was approved by the FDA in 2002, can be prescribed by general practitioners and obtained at neighborhood pharmacies, many ordinary drugstores do not stock the medication – and those that do carry it ration the number of prescriptions filled. Extended-release naltrexone can be administered by any practitioner licensed to prescribe medications, but treatment requires the development of a risk evaluation and mitigation strategy for each patient, who must receive an intramuscular injection every four weeks.

“Opioid use disorder is a brain disease, not a character defect or personality flaw, and evidence-based, effective treatment of OUD requires medication. Access to treatment is the major issue, and stringent federal and state laws and regulatory policies present substantial obstacles for patients and providers,” says Jonathan Watanabe, UCI professor of clinical pharmacy practice. “We also have to change the public perception of what achieving and maintaining recovery looks like, so that as a society we can overcome the stigma associated with taking legally prescribed medications for OUD.”

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