每日吃瓜爆料

This page provides a summary of issues impacting access to addiction treatment medications, updates, 每日吃瓜爆料's advocacy efforts to eliminate these barriers, communications from the federal agencies and Congress, select research, and a form to report access issues at pharmacies for clinicians experiencing issues.

Challenges at Pharmacies to Accessing Addiction Medications

While challenges to accessing buccal/sublingual buprenorphine at pharmacies have been a focal point for policymakers, less attention has been paid to specific challenges to accessing buprenorphine monoproduct tablets, long-acting injectable (LAI) buprenorphine, and LAI naltrexone, the latter indicated for OUD and alcohol use disorder (AUD). Finally, long standing federal regulations prohibit pharmacies from dispensing methadone when prescribed for the treatment of OUD rather than for pain.

Nonfulfillment of the Core Function to Dispense

In defining pharmacy practice, states traditionally include the core function to dispense lawful prescriptions but not necessarily a duty to so dispense. Washington, New Jersey, and California have enacted “duty to dispense” clauses; New Jersey’s law maintains pharmacy practice sites must properly dispense lawful prescriptions without undue delay. The inconsistent availability of buprenorphine for pharmacists to dispense lawful prescriptions promptly suggests certain factors are contributing to some pharmacists’ nonfulfillment of the core function to dispense, including misinterpretation of buprenorphine’s associated risks, and addiction stigma. Indeed, pharmacy organizations are establishing consensus-based guidelines for pharmacy access to buprenorphine. Factors resulting in nonfulfillment of the core function to dispense could be addressed by programs that facilitate the dispensing of opioid agonist medications lawfully prescribed for OUD, such as those providing financial incentives to retail pharmacies.

Ambiguity Related to Pharmacists’ Corresponding Responsibility

Another determining factor contributing to access challenges at pharmacies is pharmacists’ application of, and attempts to resolve, red flags applied to buprenorphine prescribed for OUD under DEA policy, which is largely imposed on DEA-registered pharmacies and pharmacists through adjudication. Under DEA regulations, pharmacists have “corresponding responsibility” with prescribing practitioners for the proper prescribing and dispensing of controlled substances. To be “effective,” controlled medication prescriptions must be “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his [sic] professional practice.” “Knowingly filling” a purported prescription for a controlled substance that was not so issued is subject to penalties. While the DEA recommends best practices for identifying out of scope prescriptions in The DEA’s Pharmacists’ Manual, pharmacies must generally glean red flags from the DEA’s regular enforcement actions. These enforcement actions – for certain controlled medication dispensing practices when red flags suggestive of diversion were not resolved prior to dispensing – revoke pharmacies’ DEA registrations. Red flags commonly cited in such actions include pattern prescribing, patients traveling far distances, cocktail/drug combination or cash payment for prescription medication, therapeutic duplication, and doctor shopping. State boards of pharmacy may also levy fines, place on probation, suspend, or revoke licenses for not preventing diversion effectively.

Other Legal Compliance Concerns

DEA-registered manufacturers and distributors must report “suspicious orders,” including unusual sizes, patterns, or frequencies of orders of controlled substances to the DEA and relevant division offices, which may be done through the DEA’s centralized database, the Suspicious Orders Report System (SORS) required by 2018 federal legislation. In 2023, the DEA clarified that neither the DEA, nor the CSA as amended in 2018, regulates the volume of controlled substances with quantitative thresholds that limit registrants’ ordering or dispensing, but rather requires registrants to design and operate a system to identify suspicious orders, which may involve the use of self-set purchasing thresholds.

Settlement agreements among states attorneys general, including with Walmart, Walgreens, and CVS, and Cardinal Health, AmeriSourceBergen, and McKesson, the latter three denoted “Injunctive Relief Distributors” under an agreement effective July 2021, likely exacerbated legal compliance concerns, especially within retail chain pharmacies. The agreement with Injunctive Relief Distributors requires them to implement systems applying specific metrics for identifying “Red Flags,” using specific dispensing datasets that are provided by their retail pharmacy customers to (1) review the total number and dosage units of dispensed prescription medications, (2) evaluate sales of controlled substances to cash-paying patients, (3) review the top prescribers of certain “highly diverted” controlled substances, and (4) consider the extent to which a pharmacy serves out-of-area patients. Under Injunctive Relief Distributors’ settlement agreement terms, “highly diverted” substances can include buprenorphine.

The presence of patients at pharmacies who have an undefined distance to their prescriber, pay in cash, or use medication ‘slang,’ can cause some pharmacists not to dispense buprenorphine, and further, it can cause some pharmacists to require patients/prescribers to provide diagnostic codes on prescriptions, prescribers to confirm via telephone the patient’s medication dose or quantity or the prescribers’ location and specialty, or finally, for some pharmacists to state counterfactually that the pharmacy simply does not stock buprenorphine. Although the DEA advised registered distributors in March 2024 to reexamine self-set thresholds to ensure timely patient access to buprenorphine, buprenorphine dispensing challenges persist.

Unique Challenges Related to Certain Addiction Medication Formulations

Buprenorphine is available alone (“BUP”) or in combination with naloxone (“BNX”), the latter intended to prevent misuse. Practice guidelines and payers’ restrictions discourage the prescription of BUP for OUD treatment unless a clinical exception applies. However, the addition of naloxone to buprenorphine may not add any real misuse deterrent utility, indicating the use of BUP outside those narrow clinical exceptions is also appropriate at the prescribers' professional discretion. After an initiation period with buccal/sublingual BNX or BUP, buprenorphine is available in a monthly or weekly LAI formulation (“Sublocade” or “Brixadi”) that eliminates daily dosing; however, both LAI medications are costly, their coverage made contingent on payers’ utilization management policies, and both are subject to a federally-required restricted distribution system (Risk Evaluation and Mitigation Strategy or “REMS”) intended to prevent their direct dispensing to patients and potential self-administration. Thus, REMS limits the ability to order and dispense Sublocade and Brixadi to only certified health care settings and pharmacies with procedures and processes in place that include prohibiting the distribution, transfer, loan, or sale of Sublocade and Brixadi.

每日吃瓜爆料 Advocacy 

May 10, 2024: The American Medical Association, American Pharmacists Association, 每日吃瓜爆料, and American Society of Health-System Pharmacists sent a to DEA, DOJ, HHS, SAMHSA, and ONDCP regarding suspicious orders reporting requirements related to buprenorphine prescribing. The letter asked DOJ/DEA to not enforce suspicious order reporting requirements for buprenorphine.

July 18, 2024: 每日吃瓜爆料 releases public policy statement on The Role of Pharmacists in Medications for Addiction Treatment.

Resources

If you or your patient is experiencing issues obtaining bupreno