A URI pharmacy professor joins a national organization promoting better access to medications for opioid use disorder.

KINGSTON, RI – Nov. 25, 2024 – The federal Drug Enforcement Administration and Substance Abuse and Mental Health Services Administration should ease rules to allow pharmacies to provide methadone to people seeking treatment for opioid use disorder, according to the URI College of Pharmacy Clinical Professor Jeffrey. Bratberg, who wrote a major report with researchers at The Heller School for Social Policy and Management at Brandeis. University, led by Legislative Analysis and Public Policy Association.

The move would improve access to medication for those with opioid use disorder, only 18 percent of whom received any medication to treat it by 2023, despite the success of prescription drugs prevent opioid addiction and increase treatment retention. It would specifically increase access to methadone, one of three medications approved by the FDA for opioid use disorder, which may be the most effective medication for treating patients using fentanyl uncontrollable. Methadone is currently only available through one of the 2,100 state-regulated opioid treatment programs across the country. Meanwhile, there are more than 60,000 pharmacies, and most people live within five minutes of a pharmacy. This availability makes pharmacies an easy place to get methadone.

Worldwide, pharmacy access to methadone is a standard of care. IN the United States, existing laws allow for the establishment of OTP satellite facilities, called “treatment units,” to increase access to methadone.

“Lack of medical centers across the country…. “suggests that current laws and regulations create enough administrative, administrative and financial difficulties that OTPs rarely attempt to establish them,” the report says, while a new LAPPA report found that groups of opioid therapy few, if any, pharmacies.

The report’s authors outline four steps federal agencies that regulate methadone for opioid use disorder can take to reduce restrictions and increase access to prescription drugs:

• Simplify the multiple and lengthy approval processes for pharmaceutical units required by the DEA and SAMHSA.
• Repeal the DEA’s rules that require any pharmacy that operates a prescription drug unit to use hard storage of methadone for the treatment of OUD. In general, the DEA requires pharmacies to store methadone prescribed for pain and other controlled substances in a securely locked, heavily-built cabinet. But pharmacies will need to store methadone for OUD in a safe or storage facility, storage requirements that will involve significant costs.
• Clarify DEA rules to allow pharmacies to order methadone with other controlled substances, using the same drug delivery and administrative procedures, to prevent other states from forcing them to obtain methadone from a source and a loved one.
• The DEA may specify that pharmaceutical facilities may use the inventory, recordkeeping, and reporting systems they already use for all other controlled substances they transport. Current DEA regulations require a specific record and inventory system for all activities related to OTPs. For chemicals that act as components of OTP medicines, “this appears to mimic existing chemical records and inventory management,” the report says.

Some countries have a terrible effect on chemicals that act as OTP pharmaceutical centers, especially in those that require a certificate of need, barriers to expansion that often include long and expensive processes more money to cover the cost of new health services. The report recommends that countries provide laws or regulations that clearly allow for a “simple and organized process” for pharmaceutical components.

Finally, the report provides advice to Congress should it consider legislation allowing pharmacists to dispense methadone for OUD without requiring any relationship with the OTP. The report recommends that the statutory language leave no room for construction of state agency rules that could cause implementation problems, such as onerous storage requirements or strict guidelines for budget eligibility. his.

Laws and regulations governing methadone require OTPs to seek approval from federal, state, or local agencies before proceeding with pharmaceutical or other activities. This leaves many rules and policies to be defined by people in those organizations, highlighting the need for clear consents to reduce barriers to treatment.

“Medication for opioid use disorder saves lives,” Bratberg said. “Patients should have easy access to methadone for their opioid use disorder the same way they can get methadone for pain relief—from their pharmacy. This way , operators can provide comprehensive, patient-centered care for their patients with opioid use disorder, by providing all available medications proven to treat it.”