Buprenorphine can only be prescribed by waiver pharmacists, limiting access to this necessary treatment for communities.
Opioid use disorder (OLD) and overdose deaths are an epidemic. During the COVID-19 pandemic, opioid deaths in the United States rose by 45% — to 107,622 overdose deaths in 2021, according to the CDC.1 Despite these high numbers, when individuals with OLD or their caregivers ask their pharmacist for help, all too often the answer is “I can’t.”
“The barriers to patient access to medication for opioid use disorders” [MOUD] are decades old, anchored in our clinics, our regulations and our attitudes that stigmatize OLD and [individuals] who have OUD,” said Anna Legreid Dopp, PharmD, CPHQ, senior director of clinical guidelines and quality improvement at American Society of Health-System Pharmacists in Washington, DC. “But the evidence is there that MOUD reduces mortality and facilitates recovery, and we’re seeing change.”
There are decades of data supporting the effectiveness of naltrexone, buprenorphine, and methadone for treating OUD, and nearly as many decades of legal and regulatory restrictions on their use. Naloxone — used to reverse acute opioid overdose — is the first clear success in the ongoing battle against opioid fatalities, said Anne Burns, RPh, vice president of professional affairs for the American Pharmacists Association in Washington, DC. Although naloxone saves lives, it does not treat OUD.
Naltrexone, a complete opioid blocker, is usually formulated as an injectable and is rarely used for MOUD because of the discomfort of routine injections and unwanted side effects, including headache, fatigue, joint and muscle pain, loss of appetite, and vomiting. Methadone is a full opioid agonist that is dispensed in pharmacies for analgesia, but can only be used for MOUD in federally approved opioid treatment programs.
Buprenorphine, a partial opioid blocker, is also provided for analgesia. As a Schedule III narcotic, it can be prescribed and titrated by pharmacists if state practice permits. However, prescribing or titrating the same buprenorphine for MOUD is restricted to clinicians exempt under the Drug Addiction Treatment Act of 2000 (DATA 2000).
These exemptions, sometimes referred to as X exemptions, were originally limited to physicians who met specific educational requirements. Subsequent legislation extended exemptions to physician assistants and nurse practitioners, but not pharmacists.
“Regulations that ensure patients can get the right level of care where and when they need it, so [patients] could potentially get methadone and buprenorphine in community pharmacies — and if pharmacists can prescribe or order these drugs where it’s part of their practice — could go a long way toward expanding access,” said Bethany DiPaula, PharmD, BCPP, FASHP, who is part of a primary care practice focused on substance use disorders in Baltimore, Maryland, is also a professor and director of the PGY2 Psychiatric Pharmacy Residency Program at the University of Maryland School of Pharmacy.
“I can enter buprenorphine prescriptions into our electronic order entry system, but they are actually prescribed by a practice physician, not me,” she said. “That’s an extra step, an extra threshold, to give a treatment that works. Internationally, pharmacists dispense MOUD in community pharmacies and studies have been conducted on the expansion of MOUD in community pharmacies in this country. DATA 2000 is the big hang-up.”
However, that could change. A coalition of pharmacy, medical and other groups has urged both to expand DATA 2000 exemptions for pharmacists and eliminate the exemption requirements altogether. In June, the United States House of Representatives passed HR 7666, the Restoring Hope for Mental Health and Well-Being Act of 2022. The bill would eliminate the need for pharmacists and other clinicians to obtain a DATA 2000 waiver. to administer MOUD, but would continue current training requirements.
“Patients in need should have access, but this established solution is hampered by unnecessary and unproven bureaucratic processes,” said Timothy D. Fensky, RPh, DPh, president of the National Association of Boards of Pharmacy in 2021 in Suffolk County, Massachusetts. “Pharmacists are well positioned to break down barriers and help more patients with OUD access the treatment they need.”
Facing the stigma
Only about 20% of individuals who could benefit from MOUD actually get it, Burns noted. Stigma in the community, from law enforcement, government and healthcare, gets in the way.
“There are pharmacists who feel that if they dispense buprenorphine, [they are] trading one addiction for another,” Burns said. “Some addiction specialists say it’s being diverted into the street, which is probably a good thing. If someone is taking buprenorphine versus heroin or fentanyl, it’s very unlikely they’ll overdose. MOUD calls for a different mindset.”
Some in law enforcement are aware of this mindset. “The major barriers to expanding MOUD access… are often based on misguided stereotypes and stigmas about treatment and diversion issues,” wrote United States assistant attorneys David Sinkman, of the Eastern District of Louisiana, and Gregory. Dorchak, of the District of Massachusetts in the Department of Justice Journal of Federal Law and Practice in 2020.3 “Equating the prescription use of MOUD with addiction ignores the fact that most chronic illnesses require long-term medication use. [Although] people with high blood pressure are dependent on their blocker medication, they are not addicted. The same goes for MOUD.”
Buprenorphine has a low potential for abuse because it blocks opioid euphoria and other positive reinforcement. Its street appeal is that it also blocks opioid cravings. “I’ve had new patients who can tell me what dose of buprenorphine they need because they’ve used it on the street to treat themselves,” DiPaula said. “There is good data showing that a subset of distractions are associated with self-medication.”
But unfortunately pharmacists stigmatize OUD no less than other providers. “Long-term data shows that medication helps prevent and helps prevent relapses [individuals] to be opioid-free, productive members of their communities,” said Grace Allen, RPh, chief operating officer of Pursue-Care, a telehealth startup specializing in mental health treatment and substance use in Huntington, West Virginia. “It’s like the difficulties of getting oral contraceptives when they first came out. The stigma and judgment that every woman trying to get that prescription gets filled at the pharmacy [faced] was almost overwhelming. It’s the same kind of situation for patients [with substance use disorder] trying to get their meds.”
Scheme and compensation
It’s not just individual pharmacists who bias patients, Allen noted that some pharmacy chains discourage retail outlets from taking on patients who need MOUD or from filling MOUD prescriptions. “Wholesalers have certain controlled substance issuance patterns that they expect to see, and chains don’t want to lose their purchasing power,” she said. “It’s terrifying to think you could be cut off from ordering drugs because you don’t fit into an algorithm that doesn’t account for drugs for substance use disorders.”
In turn, wholesalers are trying to avoid the attention of the Drug Enforcement Administration (DEA), which has been cracking down on the sale of opioids in recent years. It is unclear how the DEA views the MOUD issue. The agency praised the steps taken to expand access to MOUD in a March 2022 press release, listing “regular contacts with pharmacists and practitioners to show support for the use of drug therapy for people suffering from a disorder.” in the use of resources.”
But what that reach has delivered is unclear. “DEA hears from many advocacy groups, including ASHP,” Dopp said. “There is positive momentum with other stakeholder groups to try to educate and advocate within the DEA to create change.” Ongoing discussions with the agency have brought no noticeable changes in policy or enforcement, she added.
“It’s a tangled web of barriers for pharmacists looking to care for patients,” said Hannah Fish, PharmD, CPHQ, director of strategic initiatives for the National Community Pharmacists Association in East Greenwich, Rhode Island. “All of these regulations are actually limiting access to care rather than increasing access.”
In addition to overcoming these barriers, MOUD can also be a financial burden as it is a time-consuming, intensive practice. Few payers adequately reimburse pharmacists for the time involved. “[When] to deal with [patients with] substance use disorder, you have to think back to why you got into pharmacy,” Allen said. “When you see in real life how these people have changed their lives with good care and the right medication at a pharmacy that takes no effort at all to fill their prescriptions, it reminds you why you are in this practice in the first place.”
- Atkins J, Dopp AL, Temaner EB. Combating the stigma of addiction – the need for a comprehensive approach to the health system. NAM perspective. 2020;2020:10:31478/20202011d. doi:10.31478/20201d
- Sinkman DH, Dorchak G. Using the Americans With Disabilities Act to Reduce Overdose Deaths. Dep Justice J Fed Law Pract. 2022;70(1):113-127.
- Ending the stigma of addiction. Unbreakable. Accessed July 13, 2022. https://www.shatterproof.org/our-work/ending-addiction-stigma
- Report of the ASHP Opioid Task Force. Am J Health System Pharm. 2020;77(14)::1158-1165. doi:10.1093/ajhp/zxaa117
- Opioid Use Disorders. College of Psychiatric and Neurological Pharmacists. Accessed July 13, 2022. https://cpnp.org/ed/old
- Educational resources. ONE (Opioid and Naloxone Education). Accessed July 13, 2022. https://one-program.org/pharmacists/
- Joint action to fight the US opioid epidemic. National Academy of Medicine. Accessed July 13, 2022. https://nam.edu/programs/action-collaborative-on-countering-the-us-opioid-epidemic/
- Trainings and webinars. American Pharmacists Association. Accessed July 13, 2022. https://pharmacist.com/Practice/Patient-Care-Services/Opioid-Use-Misuse/Opioid-Training-and-Webinars