Addressing the Escalating Problems That Patients Encounter When Filling Buprenorphine Prescriptions

Buprenorphine reduces the risk of overdose death by 50%, and it helps people achieve long-term recovery. Although buprenorphine was approved as a treatment for opioid use disorder 36 years ago, integration into routine clinical practice is still an uphill battle. The federal government has expanded access by funding programs to train and provide ongoing support for clinicians. These efforts have been effective: between 2017 and 2020, the number of clinicians with a Drug Enforcement Administration (DEA) waiver to prescribe buprenorphine increased from 37 869 to 98 344.¹ Federal legislation passed in December 2022 eliminated the waiver to prescribe buprenorphine. Today, any clinician with DEA approval to prescribe Schedule III medications can prescribe buprenorphine.

As the number of clinicians prescribing buprenorphine has increased, there is growing awareness of the problems that patients encounter when attempting to fill their buprenorphine prescriptions at pharmacies. Clinicians have reported not being able to find pharmacies willing to fill their patients’ buprenorphine prescriptions. Patients who cannot immediately fill their prescriptions are at high risk of relapsing to illicit opioid use and overdose death. In the absence of national prevalence data on such problems, a West Virginia study found that 34% of patients had problems filling their buprenorphine prescriptions within the past year.¹ While this was not a prospective study, participants reporting problems filling their prescriptions were also more likely to report nonmedical use of buprenorphine.¹ It is not surprising that individuals may seek out illicit opioids when they cannot access legitimate pathways to treatment.

Clinicians and policymakers struggle to understand why patients are unable to fill their buprenorphine prescriptions. The reasons are complex and multilevel and extend well beyond the walls of the pharmacy. Sometimes pharmacies state that they are unable to order more buprenorphine because of supplier caps. These caps are related to the injunctive relief terms agreed to by states’ attorneys general and the 3 largest wholesalers in the country. The injunctive relief terms require that drug suppliers monitor pharmacy orders and report unusual orders to the Suspicious Orders Report System (SORS),² which could result in a DEA audit and a decreased supply of controlled medications. To comply with injunctive relief terms, drug suppliers developed their own algorithms, which are not publicly available nor communicated to pharmacies. These algorithms are described as a ratio of noncontrolled to controlled drugs based on the pharmacy’s ordering history; however, wholesalers may flag individual controlled substance orders. If pharmacies have an influx of new patients attempting to fill any controlled medications, this could trigger a SORS report. To avoid a SORS report, pharmacists may refuse to dispense or limit the number of buprenorphine prescriptions that they fill.² Based on our experiences, patients may be told that the pharmacy is no longer accepting new patients. These challenges have existed for several years now,^3,4 even though they have received little attention.

Unfortunately, problems patients face at pharmacies have worsened over the past year (Table).⁵ Part of the problem may be caused by a pharmacist shortage, although there is disagreement regarding whether there is a national shortage or whether corporations are using pharmacist staffing models that are insufficient to meet demand. In January 2023, Express Scripts, a pharmacy benefit manager, changed their pharmacy reimbursement rates, which essentially reduced the number of pharmacies that patients could use to fill prescriptions. Restrictions on in-network pharmacies may not be as problematic in large metropolitan areas, but they can be significant in rural communities. Nationally, Express Scripts has a 24% market share, but it has a dominant share (>70%) in states like West Virginia and Tennessee.

Table.

Problems and Potential Solutions Around Filling Buprenorphine Prescriptions at Pharmacies

Problem	Solution
Federal
Limits on pharmacy orders for buprenorphine	Exempt buprenorphine from algorithms used to generate SORS reports.
	Prohibit suppliers or distributors from limiting buprenorphine orders.
Investigative action in response to suspicious buprenorphine orders	Make buprenorphine orders exempt from investigative action when pharmacies have valid prescriptions from currently licensed prescribers.
Multiple pharmacies refuse to fill buprenorphine prescriptions	Identify a mechanism to allow buprenorphine to be shipped directly to the patient’s home.
State and health insurance payers
Delays in filling buprenorphine prescriptions due to prior authorizations	States should pass legislation prohibiting buprenorphine prior authorizations for all health insurance payers.
In-network pharmacies limit access, particularly in rural communities	States should pass legislation that makes buprenorphine exempt from in-network pharmacy restrictions by health insurance payers.
Pharmacist stigma toward patients with OUD and concerns regarding diversion	Continuing education credits for pharmacist should integrate empirically demonstrated strategies to reduce stigma and to help distinguish behaviors that reflect potential diversion from those exhibited by patients early in recovery.
Pharmacies unwilling to stock buprenorphine	States should pass legislation requiring pharmacies to stock at least 1 buprenorphine product.
	States should adopt the recommendations from the National Association of Boards of Pharmacy and National Community Pharmacists Association.5
Clinicians and health systems
Patient lack of awareness of optimal time window to fill buprenorphine prescriptions	Develop educational information that reflects state and health insurance payer policies regarding when buprenorphine prescriptions can be refilled.
	Send patients reminders about when to fill their buprenorphine prescriptions via EHR and use EHR-integrated pharmacy tools (where available) to determine if buprenorphine prescriptions were filled in time.
	Develop policies to rapidly contact patients who were unable to fill buprenorphine prescriptions, and develop mechanisms to fill prescriptions within the prescriber’s health system when possible or until a local pharmacy can confirm their capacity to fill patients’ prescriptions.
Lack of awareness of health insurance restrictions and in-network pharmacies	Encourage patients to review their pharmacy benefits and work collaboratively to help them find recovery-friendly pharmacies that are capable of filling buprenorphine prescriptions in a timely manner.
Delays in filling buprenorphine prescriptions	Automatically send buprenorphine refills electronically to the pharmacy.

Abbreviations: EHR, electronic health record; OUD, opioid use disorder; SORS, Suspicious Orders Report System.

Certainly, not all responsibility lies with pharmacies, as dispensing practices are constrained by reimbursement policies defined by health insurance payers, opaque wholesaler supply limits, and compliance with state regulations. Insurance-related barriers, including quantity limits or brand-specific formularies, may not be identified until a patient presents their prescriptions to the pharmacy. Prior authorizations cause dispensing delays, and patients may not be aware that some pharmacies may not accept their insurance. Pharmacists’ training in how to identify potential diversion can also be a contributing factor. Red flag protocols may be triggered by prescriptions from a nonlocal prescriber or patient, which could be seen as “pharmacy shopping.” In addition, individuals early in their recovery may appear suspicious. Of course, like many health care professionals, pharmacists may have stigmatizing beliefs about individuals who use drugs, which may implicitly bias their dispensing decisions.

Action at the federal level to address pharmacy-related barriers to buprenorphine is long overdue. As previously recommended, the DEA should strongly urge suppliers to make buprenorphine orders exempt from SORS reports² and state regulations should exempt pharmacies from investigation or penalties due to increases in buprenorphine orders. State or federal regulations could mandate pharmacies to stock at least 1 buprenorphine product, require pharmacies to fill buprenorphine prescriptions from valid prescribers, and expand home delivery options.² The Centers for Medicare & Medicaid Services (CMS) should immediately remove prior authorizations for buprenorphine, and private insurance payers should be strongly encouraged to as well; CMS should also make buprenorphine exempt from in-network pharmacy restrictions. Pharmacist education on how to identify diversion should be modified to distinguish patients in opioid withdrawal and those filling buprenorphine prescriptions written by clinicians known to be providing legitimate treatment. Educational curriculum can be updated to reflect that nonlocal prescribers or patients may present because of limited availability—again, a particularly acute issue in rural areas.

While action at the federal level is essential to expanding pharmacies’ capacity to fill buprenorphine prescriptions, these changes may take time and clinicians may need strategies that can immediately help their patients. Clinicians and treatment programs should identify recovery-friendly pharmacies in their communities that are capable of dispensing buprenorphine, and buprenorphine prescribers could adopt strategies (eg, electronic health record–integrated pharmacy dispensing tools) to quickly determine whether patients are able to fill their prescriptions. It is time for policymakers and regulators to loosen the reins on buprenorphine dispensing and finally take bold action to ensure that patients can get their valid prescriptions filled in a timely manner, before it is too late.