Buprenorphine can only be prescribed by pharmacists with exemptions, limiting access to this necessary treatment for communities.
Opioid use disorder (OUD) and overdose deaths are an epidemic. During the COVID-19 pandemic, opioid overdose deaths in the United States soared 45%, to 107,622 drug overdose deaths in 2021, according to the CDC.1 Despite these high numbers, when people with OUD or their caregivers ask their pharmacist for help, the answer is too often “I can’t”.
“Barriers to Patient Access to Medications for Opioid Use Disorders [MOUD] are decades old, rooted in our clinics, regulations and attitudes that stigmatize the OUD and [individuals] who have OUD,” said Anna Legreid Dopp, PharmD, CPHQ, senior director of clinical guidelines and quality improvement at the American Society of Health-System Pharmacists in Washington, DC. “But the evidence is there that MOUD reduces mortality and aids recovery, and we are seeing a change.”
There are decades of data supporting the effectiveness of naltrexone, buprenorphine, and methadone for treating TOU, and almost as many decades of legal and regulatory restrictions on their use. Naloxone, used to reverse acute opioid overdoses, is the 1 clear success story in the ongoing fight against opioid-related deaths, 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 ULT.
Naltrexone, a full opioid blocker, is most often formulated as an injectable and is rarely used for MOUD due to the inconvenience 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 distributed in pharmacies for pain relief, but can only be used for MOUD in federally approved opioid treatment programs.
Buprenorphine, a partial opioid blocker, is also dispensed for analgesia. As a Schedule III narcotic, it can be prescribed and titrated by pharmacists if permitted by state practice law. However, prescribing or titrating the same buprenorphine for MOUD is restricted to clinicians who hold a waiver under the Drug Addiction Treatment Act of 2000 (DATA 2000).
These waivers, sometimes referred to as X waivers, were originally reserved for physicians meeting specific training requirements. Later legislation extended the exemptions to physician assistants and nurse practitioners, but not pharmacists.
“Regulation that would allow patients to receive the appropriate level of care where and when they need it, so [patients] could potentially receive methadone and buprenorphine from community pharmacies – and the fact that pharmacists can prescribe or order these drugs where it is within their scope of practice – could go a long way to expanding access,” said Bethany DiPaula, PharmD, BCPP, FASHP, part of a primary care practice focused on substance use disorders in Baltimore, Maryland. She 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 prescription entry system, but they’re actually prescribed by a medical practitioner, not me,” she said. “It’s an extra step, an extra hurdle, to providing a treatment that works. Internationally, pharmacists provide MOUD as part of the community pharmacy, and studies have been conducted on the expansion of MOUD into community pharmacies in this country. DATA 2000 is the big deal.
However, that could change. A coalition of pharmaceutical, medical and other groups pushed the two to extend DATA 2000 waivers to pharmacists and eliminate waiver requirements altogether. In June, the United States House of Representatives passed HR 7666, the Restoring Hope for Mental Health and Wellness Act of 2022. The bill would eliminate the need for pharmacists and other clinicians to obtain a DATA 2000 waiver to administer MOUD, but continue current training needs.
“Patients in need should have access to it, but this well-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 help break down barriers and allow more patients with TOU to access the treatment they need.”
Facing the stigma
Only about 20% of people who could benefit from MOUD actually get it, Burns noted. Stigma in the community, from law enforcement, government and the health care industry, stands in the way.
“There are pharmacists who think that if they dispense buprenorphine, [they are] trading one addiction for another,” Burns said. “Some addiction specialists say it’s diverted to the streets, which is probably a good thing. If someone is using buprenorphine rather than heroin or fentanyl, it’s very unlikely that they overdose.MOUD requires a different mindset.
Of this mindset, some in law enforcement are taking note. “The main barriers to expanding access to MOUD…are often based on erroneous stereotypes and stigma regarding treatment and diversion issues,” wrote Assistant United States Attorney 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 prescription MOUD use with addiction overlooks the fact that most chronic diseases require long-term drug use. [Although] those with high blood pressure are dependent on their β-blocker medications, they are not dependent. The same goes for the MOUD.
Buprenorphine has low abuse potential because it blocks opioid euphoria and other positive reinforcers. Its street appeal is that it also blocks the craving for opioids. “I’ve had new patients who can tell me what dose of buprenorphine they need because they’re using it on the streets for self-medicating,” DiPaula said. “There is good data showing that a subset of diversion is associated with self-medication.”
But unfortunately, pharmacists are no less likely to stigmatize OUD than other providers. “Long-term data shows that the drugs help prevent relapses and help [individuals] be productive, opioid-free members of their community,” said Grace Allen, RPh, COO of Pursue-Care, a telehealth startup specializing in mental health and substance use disorder treatment at Huntington, West Virginia. “It’s like the difficulties in getting birth control pills when they first came out. The stigma and judgment that any woman trying to get that prescription 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 medicine.
Payment and Refund
It’s not just individual pharmacists who prejudge patients, Allen noted that some drugstore chains discourage outlets from accepting patients who need MOUD or filling MOUD prescriptions. “Wholesalers have certain models of controlled substance distribution that they expect to see, and chains don’t want to lose their ability to buy,” she said. “It’s terrifying to think that you might be blocked from ordering medications because you don’t fit an algorithm that doesn’t account for medications for substance use disorders.”
In turn, wholesalers are trying to avoid the attention of the Drug Enforcement Administration (DEA), which has clamped down on opioid sales in recent years. It is unclear how the DEA views the distribution of the MOUD. The agency touted steps being taken to expand access to MOUD in a March 2022 press release, a list that includes “engaging in regular contact with pharmacists and practitioners to express support for the use drug treatment for people with substance use disorders”.
But what this outreach accomplished is unclear. “The DEA is hearing from many advocacy groups, including the 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 produced no discernible change in policy or enforcement, she added.
“It’s a tangle of hurdles for pharmacists 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 effectively limit access to care rather than expanding access.”
In addition to overcoming these hurdles, MOUD can also be a financial strain, as it is a time- and contact-demanding practice. Few payers adequately reimburse pharmacists for time spent. “[When] treat [patients with] addiction, you have to rethink 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 medicine from a pharmacy that doesn’t give them trouble filling their prescriptions, it reminds you why you got into this practice in first place.”
- Atkins J, Dopp AL, Temaner EB. Combating the stigma of substance abuse – the need for a comprehensive health system approach. NAM perspective. 2020;2020:10:31478/202011d. doi:10.31478/202011d
- 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.
- End the stigma of addiction. Unbreakable. Accessed July 13, 2022. https://www.shatterproof.org/our-work/ending-addiction-stigma
- ASHP Opioid Task Force Report. Am J Health Syst Pharm. 2020;77(14):1158-1165. doi:10.1093/ajhp/zxaa117
- Opioid use disorders. College of Pharmacists, Psychiatrists and Neurologists. Accessed July 13, 2022. https://cpnp.org/ed/oud
- Learning tools. ONE (Opioid and Naloxone Education). Accessed July 13, 2022. https://one-program.org/pharmacists/
- Collaborative Action on Addressing the Opioid Epidemic in the United States. National Academy of Medicine. Accessed July 13, 2022. https://nam.edu/programs/action-collaborative-on-countering-the-us-opioid-epidemic/
- Trainings and webinars. American Association of Pharmacists. Accessed July 13, 2022. https://pharmacist.com/Practice/Patient-Care-Services/Opioid-Use-Misuse/Opioid-Training-and-Webinars