3 Approaches for Pharmacies to Dispense Methadone to Treat OUD

Methadone is a highly effective treatment for opioid use disorder (OUD) and has been found to lower the death rate for OUD by nearly 60%, but federal rules create access barriers to the medication. And that contributes to a persistent treatment gap; only about 1 in 5 people with OUD receive any type of medication treatment.

In part, that’s because the federal government requires that—with rare exception—methadone for OUD be dispensed only at opioid treatment programs (OTPs), more widely  known as methadone clinics. But the number and location of these clinics are not meeting the need. About 80% of U.S. counties and the entire state of Wyoming lack even one OTP. In many jurisdictions, clients have to travel long distances to receive their daily dose.

Pharmacies, meanwhile, are a tremendously underused outlet for expanding access to methadone, and new research from the Brandeis Heller School for Social Policy and Management—with support from The Pew Charitable Trusts—explores approaches that could help to close the gap.

While there are about 2,100 OTPs throughout the U.S., there are more than 60,000 community pharmacies, and around 90% of people live within 5 miles of one. In other countries, such as Canada, Australia, and the United Kingdom, community pharmacies have provided methadone to treat OUD for decades. 

Although there are multiple regulatory and statutory barriers that impede pharmacy dispensing of methadone in the U.S., proponents of expanding access also face a practical barrier—the lack of business models for implementing pharmacy access in ways that generate sufficient revenue. Such information could encourage uptake of this approach.

Informed by interviews with pharmacies, OTP leaders, individuals with lived and living experience taking methadone, policymakers, and health care payers, the Brandeis briefs outline three profit-generating business models for pharmacies to dispense methadone for OUD: the medication unit model, the pharmacy-dispensed methadone model, and the enhanced pharmacy-dispensed methadone model. The research includes the projected returns on investment for pharmacies that implement each of these models.

OTP-pharmacy partnership: Medication unit model

This approach, which is currently allowed by federal statutes and regulations, entails the partnering of OTPs and pharmacies to operate satellite methadone dispensing sites at the pharmacies. However, this model is rarely used for several reasons, including a lack of knowledge, regulatory burden, and financial viability. The pharmacists essentially operate as part-time staff members for the OTP, which allows them to dispense methadone at the pharmacy. Clients with OUD can pick up their methadone at a frequency determined by the OTP (daily, weekly, or monthly) and receive other OTP services through the medication unit, but they can also continue to go to the OTP for any required counseling, toxicology screening, or other related services.

The business model’s assumptions—or data-informed decisions—regarding cost-sharing between the pharmacy and OTP, staffing, patient volume, and pharmacy administration of methadone for OUD found that over three years, a pharmacy could net $6.43 for every dollar spent, yielding a total profit of around $177,000 by the end of the third year.

Though such initiatives are allowed under federal rules, very few medication units exist in pharmacies. That’s because these models must follow Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) regulations, which require pharmacies to store and track methadone for OUD separately from methadone dispensed for pain—a costly and cumbersome hurdle. The brief notes that the federal government could clarify steps to establish medication units in pharmacies and streamline DEA and SAMHSA approval processes if policymakers want to encourage this model’s expansion.

Pharmacy-dispensed methadone model

This model—not currently allowed in the U.S.—would allow pharmacies to dispense methadone for OUD when prescribed by a DEA-registered medical provider, following the same ordering, tracking, storage, and disposal processes they do for all other controlled substances. The client is under the care of a medical provider who determines the need for and conducts any necessary counseling, toxicology testing, or related services.

Researchers note that changes to federal regulations or the associated statutes would be required to realize this model, along with an alignment with state laws. Clear regulations and protocols for providers and pharmacies would further facilitate the success of this approach.

The assumptions used in this model found that, over three years, a pharmacy would net $2.05 for every dollar spent, potentially yielding a total profit of more than $19,000 by the end of the third year.

Enhanced pharmacy-dispensed methadone model

The final model—also not permitted under current federal law—allows more services to be performed by pharmacists, including dispensing methadone for OUD prescribed by medical providers. This model requires the same changes at the federal level as described for the pharmacy-dispensed methadone model.

Additionally, under this model, pharmacists would be granted an expanded scope of practice to allow them to provide clinical services such as initiating methadone treatment, medication management, toxicology testing, and other supportive services. Pharmacists would be given federal and state provider status, which enables them to bill and be reimbursed by insurers for these professional services.

The assumptions used in this model yielded $2.33 for every dollar spent over three years, generating a total profit of approximately $128,000 by the end of the third year.

Policymakers should consider real world returns and impact

In practice, the actual profits could differ from the models, though sensitivity analyses conducted by the researchers still found positive returns on investment under all tested conditions. And in all models, pharmacists may require extra training, OTPs could face financial impacts, and insurers could need to adjust their reimbursement practices.

Importantly, the authors note, pharmacies and OTPs should also expect to benefit from a greater uptake in effective addiction treatment, and clients would have increased access to lifesaving care.

Alex Duncan is a director and Frances McGaffey is a manager with The Pew Charitable Trusts’ substance use prevention and treatment initiative. Jane Koppelman formerly worked at Pew on the same initiative.