Overcoming Barriers for Opioid Use Disorder Treatment and Drug Overdoses: Moving Forward

The opioid epidemic is an ongoing and serious public health issue, and efforts from government agencies, national and local organizations, and dedicated healthcare providers continue to identify and address challenges facing the growing number of individuals with substance abuse issues and the rising number of lives lost to drug overdoses each year. The stigma correlated with opioid use disorder (OUD), lack of access to health care, lack of insurance, and out-of-pocket costs are some of the most common types of barriers to accessing and maintaining treatment that are documented in the literature.¹

According to the Substance Abuse and Mental Health Services Administration (SAMSHA), having access to effective treatment of substance use disorders can diminish the risk of overdose and assist in improving clinical outcomes in patients.² The SAMHSA also notes that OUD is a chronic disease and warrants safe and effective treatment.² There are three FDA-approved medications to treat OUD, including buprenorphine, methadone, and naltrexone. Methadone and buprenorphine have been correlated with substantial decreases in mortality due to overdoses.²

FDA Approvals for Over-the-Counter Use

• March 2023: Narcan³
• July 2023: RiVive

In a press release, FDA Commissioner Robert M. Califf, MD stated, “We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health. The agency has long prioritized access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA.”⁴

While the recent FDA approval of naloxone to OTC status provides greater and easier accessibility to patients, several publications indicate that cost will be a barrier for many individuals who need naloxone. According to the GoodRx website, the price varies from pharmacy to pharmacy, and geographic location.

Recently, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) of the Department of Health and Human Services (HHS) issued a press release stating its agency was permanently implementing flexibilities that were used during the COVID-19 pandemic to eliminate barriers for patients to access care at Opioid Treatment Programs (OTPs) and challenges often encountered by providers in treating patients with OUD, and changes will enable patients with OUD to receive take-home method doses.^5-7 The effective date of this final rule is April 2, 2024, and the compliance date is set for October 2, 2024. Key information from the final rule includes:^5-7

Allowing commencement of treatment via telehealth, including methadone via audio-visual telehealth technology and buprenorphine via audio-only technology, to remove transportation barriers.

• Increasing provider eligibility to permit nurse practitioners and physician assistants to order medications in opioid treatment programs (OTPs), where state law permits, decreases the burden on OTP operations and improves patient access to medications.
• Addressing barriers and expanding access to therapy to more individuals by eliminating the “stringent admission criteria” that had formerly necessitated patients to have a history of addiction for 1 year period before being eligible for treatment.
• Increasing access to “interim treatment” permits patients to begin medication treatment while awaiting additional services to aid in treatment.
• Promoting patient-centered models of care associated with management approaches for other chronic conditions.

To learn more about medications for treatment, visit the federal register website.

SAMSHA notes that studies reveal that take-home doses of methadone have the potential to enhance treatment adherence and diminish the risk of opioid abuse.^5-7

SAMSHA also updated its Overdose Prevention and Response Toolkit, which was released in January 2024 and provides guidance on the role of opioid overdose reversal medications and how to respond to an overdose. To learn more about the SAMSHA toolkit, visit the SAMSHA website.

In a press release, the American Medical Association stated, “The AMA applauds the final rule (PDF) by HHS that allows buprenorphine to be prescribed to patients with opioid use disorder (OUD) based on telehealth visits on a permanent basis. The AMA also applauds the final rule allowing increased access to methadone treatment for patients with OUD who are starting or continuing methadone in an Opioid Treatment Program (OTP). Cementing these policies is a step in the right direction in the fight against the worsening overdose epidemic to increase equitable access to care, reduce the stigma of seeking treatment for OUD, and embrace technology in medicine. Prescribing buprenorphine through telehealth visits provides the opportunity to reach remote and underserved communities and patients who may be unable to travel daily to in-person appointments because of distance to the OTP, cost, childcare, employment, and other factors.”⁸

Statement from Pharmacist

Retail pharmacist stated, “While the availability of OTC naloxone is a great advancement, unfortunately, many who need it may not have access to the life-saving drug either because of the lack of awareness of its OTC status, stigmas about OUD or the patient’s inability to afford the drug. It is also important to expand patient education initiatives about the proper use of OTC naloxone since prompt and proper administration is of critical importance with this life-saving therapy for OUD. I have encountered some parents with concerns about OUDs in their teens due to the ongoing opioid crisis and have been asked about the use of OTC naloxone. The problem is real, and by safe prescribing and educating patients about OUD, the risks and effects, and promoting the safe use of these analgesics, pharmacists can make a difference one patient at a time. Patient education is key.”

Conclusion

The new final rule from the HHS is a step in the right direction and hopefully will expand patient access to treatment and eliminate many of the barriers that both patients and providers face.

According to the CDC, pharmacists can be instrumental in identifying patients with substance abuse/misuse disorders as well as educating patients about the safe and proper use of medications to reduce or prevent misuse and overdoses. More information about the role of the pharmacist in preventing and reducing overdoses can be found on the Stop Overdose section of the CDC website.

References

1. Bremer W, Plaisance K, Walker D, et al. Barriers to opioid use disorder treatment: A comparison of self-reported information from social media with barriers found in literature. Front Public Health. 2023;11:1141093. doi:10.3389/fpubh.2023.1141093
2. SAMHSA Overdoes Prevention and Response Toolkit. SAMHSA. Published January 2024. Accessed March 14, 2024. https://store.samhsa.gov/product/overdose-prevention-response-toolkit/pep23-03-00-001
3. FDA Approves First Over-the-Counter Naloxone Nasal Spray. FDA website. Published March 29, 2023. Accessed February 29, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray
4. FDA approves second over-the-counter naloxone nasal spray product. News release. FDA. Published July 28, 2023. Accessed March 14, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray
5. Gliadkovskaya A. SAMHSA's final rule makes COVID-era flexibilities permanent for opioid treatment programs. Fierce Healthcare. Published February 6, 2024. Accessed March 14, 2024. https://www.fiercehealthcare.com/regulatory/samhsa-rule-makes-covid-flexibilities-opioid-treatment-programs-permanent
6. Medications for the Treatment of Opioid Use Disorder. US Dept of HHS, Substance Abuse and Mental Health Services Administration; February 2, 2024. Accessed February 29, 2024. https://www.federalregister.gov/documents/2024/02/02/2024-01693/medications-for-the-treatment-of-opioid-use-disorder
7. Firth S. HHS expands access to methadone, buprenorphine. MedPage Today. Published February 2, 2024. Accessed March 14, 2024. https://www.medpagetoday.com/publichealthpolicy/healthpolicy/108561
8. AMA applauds rule removing barriers to care for opioid use disorder. News release. AMA. Published February 1, 2024. March 14, 2024. https://www.ama-assn.org/press-center/press-releases/ama-applauds-rule-removing-barriers-care-opioid-use-disorder