Changing the Game: Pharmacy Students' Perspective on Naloxone OTC Approval

Article

To eliminate the existing stigma in the community, addiction must be recognized as a treatable condition rather than an immoral act.

On March 29th, the FDA approved the OTC use of naloxone hydrochloride 4mg nasal spray.1 The approval was granted to Emergent BioSolutions as a supplemental New Drug Application (sNDA) for a full switch from prescription-only to OTC.

The decision was based on the medication meeting all necessary criteria, including a low risk of misuse, self-explanatory label and instructions, and the benefits outweighing the risks. The product cost and availability will be determined by Emergent BioSolutions. The FDA declared that it may take months for the product to be available OTC, while other naloxone formulations and dosages will remain available by prescription only. However, the agency has committed to working with all stakeholders to ensure access to the naloxone nasal spray during the transitional period. The decision represents a significant step forward in the fight against opioid overdoses and the opioid epidemic, and it underscores the importance of ensuring access to life-saving medication for those in need.

Naloxone nasal spray | Image credit: Hanson - stock.adobe.com

Naloxone nasal spray | Image credit: Hanson - stock.adobe.com

In recent years, legal and policy developments at both the federal and state levels have expanded pharmacists' role in dispensing naloxone without a prescription. The Comprehensive Addiction and Recovery Act (CARA), passed in 2016, allows pharmacists to dispense naloxone without a prescription to individuals at risk of opioid overdose, as well as their family members and friends.2 Currently, there is no Federal Standing Order authorizing access to naloxone. As a result, naloxone’s availability is controlled individually in each state. However, all 50 states have laws allowing individuals to access naloxone. According to Florida Statutes 2022 “Emergency treatment for suspected opioid overdose,” a pharmacist can provide an emergency opioid antagonist with an auto-injection delivery system or as intranasal application delivery system, properly labeled with instructions for use.3 Dispensing can be done either under the direction of a pharmacist's order or through a nonpatient-specific Standing Order. In Florida, the statewide Standing Order for Naloxone is a formal contract between a prescriber, who is usually a state health official, Surgeon General Joseph A. Ladapo, MD, Ph.D., and all licensed pharmacists within that state. As per Florida Administrative Rules, Law, and Code, in case naloxone is dispensed to a patient who is already taking opioids, the pharmacist needs to maintain a record of the Standing Order for Naloxone along with details like patient information, drug, directions, and prescriber.4

As the availability of naloxone shifts from prescription-only to OTC, pharmacists must prioritize the ethical considerations of dispensing this medication. Currently, pharmacists must ensure that patients receive adequate counseling on proper use, potential risks and benefits, and appropriate responses to an opioid overdose. Additionally, pharmacists must safeguard the privacy and confidentiality of patients who receive naloxone. The ethical considerations align with the principles of patient’s autonomy, beneficence, and non-maleficence, but with the switch to OTC it must be ensured that patients receive the necessary information.

Pharmacy students are acutely aware of the importance of ensuring patient safety, particularly as it relates to opioid overdose. However, despite the availability of naloxone, there remain several barriers to patient access. One of the most significant barriers is the stigma that surrounds the possession or storage of naloxone.

To overcome this stigma, it is essential to promote education about the benefits of naloxone and to encourage its use as a tool for harm reduction. Additionally, new measures must be embraced to increase patient safety, such as the switch from prescription-only to OTC status. The change can eliminate the need for procedures that involve acquiring patient information, such as consultations with health care professionals or insurance plan requirements.

A campaign focused on education, accessibility, and management of naloxone should accompany the drug's availability in pharmacies and stores. However, only 19 states require training for pharmacists or dispensers on how to administer naloxone, raising concerns about its effective dispensing and administration.5 In this regard, some pharmacists have expressed concerns about liability and their comfort level in dispensing naloxone to patients without a prescription.6 To address this concern, the Good Samaritan Act provides immunity from any civil or criminal liability to a person who is authorized to possess, store, and administer emergency opioid antagonists as clinically indicated.7

In order to facilitate the dispensing and administration of naloxone, it is imperative to ensure that pharmacists are equipped with the necessary information and resources. The results of a 2018 study published in the Journal of Pharmacy Practice showed that most pharmacists are willing to dispense naloxone without a prescription, but there is a need for a more comprehensive approach to address this issue.5

Overall, several studies highlight the complex attitudes and experiences surrounding dispensing and using naloxone among individuals with opioid addiction, caregivers, first responders, and health care professionals. Although naloxone is a valuable tool for preventing opioid-related deaths, there are significant barriers to its use and acceptance that must be addressed to ensure it is widely available and effective. Some of these barriers include a lack of knowledge about naloxone, fear of legal repercussions, negative social stigma, and concerns about enabling continued drug use.8

There is currently a lack of studies collecting student pharmacists’ perspective about naloxone. A cross-sectional study developed by University of Tennessee Health Science Center (UTHSC) College of Pharmacy assessed student pharmacists’ confidence and willingness to dispense naloxone and provide counseling, while gauging their perception about the stigma of the drug. The results showed that student pharmacists are generally confident in dispensing, administering, and recommending naloxone to patients.9 On the other hand, a study from University of Wisconsin-Madison School of Pharmacy revealed that many students lack the necessary skills to counsel patients about opioid risks in general and initiate difficult conversations regarding addiction, dependence, and overdose.10

Despite the efforts throughout recent years, naloxone’s availability is still insufficient in the United States. The distribution of this medication is still failing to reach the most vulnerable populations and there is an urgent need for increasing accessibility and affordability of the medication. Stigma from medical providers and law enforcement; lack of awareness from vulnerable populations; low access to care; lack of time, training and confidence from pharmacists; and product cost are some of the barriers that limit the access of naloxone. Communities across the country are still unaware that opioid use disorder (OUD) is a chronic relapsing medical condition of the brain that requires specialized treatment and ongoing support. In addition, individuals at high-risk for opioid overdose may have incomplete comprehension of the wide range of services that pharmacists can provide, from counseling and education to naloxone distribution and medication-assisted treatment. Pharmacists can address these gaps by providing accurate information about the disorder and its underlying causes.

Community pharmacies play an essential role in helping individuals with OUD.Pharmacists and pharmacist interns in the community pharmacy setting may need to improve the initiation of conversations about naloxone with patients receiving opioid prescriptions and other vulnerable individuals at high risk for opioid overdose. Independent pharmacies may bring many benefits to the community regarding this matter because they can provide personalized care and offer flexibility. However, naloxone is currently much less accessible without a prescription in independent pharmacies (20%) compared to chain pharmacies (64%).11

The cost of naloxone can vary depending on several factors, including the formulation, dose, pharmacy, and location. Without insurance, the price for a single dose of naloxone can range from approximately $120 to $150 or more, depending on the specific product and where it is purchased.12 It is crucial to bring awareness to patients about how pharmacies can provide discounts, and how those who cannot afford naloxone may be eligible for further financial aid or initiatives like the Naloxone Co-Payment Assistance Program in New York.13

The variation in cost of naloxone between 2010 and 2018 has been analyzed in an observational study. After 2014, prescriptions for naloxone significantly increased. From 2014 to 2018, out-of-pocket amount was decreased by 26% for patients with insurance coverage; however, it was increased by 506% for uninsured individuals.14 Considering that approximately 20% of people with OUD in the United States do not have medical insurance and they represent 30% of opioid overdose deaths, price is still a huge deterrent for access to care.15

Most insurers have taken steps to ensure that naloxone is included in their formularies and covered by their plans. However, the specific accessibility of naloxone can vary depending on the tier of coverage provided by the insurance plan. The 2023 formulary drug lists of major insurers, including Blue Cross Blue Shield, Cigna, Aetna, and United Health Care, all list naloxone in different tiers of coverage. Patients covered by plans that include naloxone in higher tiers may face more barriers to obtaining the medication. Some insurers have waived prior authorization requirements or offered the medication at no cost, but these policies are not consistent across all plans. It is important for patients to be aware of their specific insurance plan's coverage for naloxone. Additionally, depending on the state, there are different ways to access naloxone that do not require processing by the health plan.

One of the downsides to the OTC approval is that cost can potentially increase due to product demand. Additionally, health insurance companies might decide not to include OTC formulations on their drug formularies anymore, especially those that offer coverage to low-income populations since they might be more affected by price changes. There might be an increase in out-of-pocket responsibilities, negatively affecting public health and augmenting the economic disparities that already exist in the country.

Another negative consequence is the widespread belief that increasing the availability of OTC naloxone could motivate individuals with OUD to consume drugs in higher doses and more frequently, knowing that the opioid reversal medication is more accessible. However, study results demystify the concern. Individuals with OUD have reported that naloxone availability does not necessarily increase risky opioid use behavior and their decision to continue using drugs is completely independent to the reversal drug.16

Other research has been conducted with participants from a methadone clinic and other treatment programs to assess opioid users’ perspectives on naloxone. According to one qualitative study, opinions fluctuated between recognizing the advantages of the life-saving medication and the disadvantages such as naloxone-induced withdrawal symptoms.17 It is imperative the targeted population and the community are educated about the physiological effects of the drug, provided with resources to overcome withdrawal symptoms, and helped to access treatment programs.

Availability of OTC naloxone will bring multiple benefits to the community. It is a safe, efficacious product; it is easy to use compared to other formulations, such as intramuscular naloxone; and it will be available at convenience stores, grocery stores, gas stations, online stores, and other locations where there are no pharmacies.12 As access to naloxone increases in the community, the opioid overdose mortality rates may decrease too, allowing individuals with OUD to have a second chance and begin treatment.

The National Institute on Drug Abuse is funding research that will identify community-specific factors that contribute to the high rates of opioid misuse, overdose deaths, and the concomitant spread of infectious disease.18 The research will also assess promising evidence-based prevention and treatment interventions, including the use of naloxone for overdose treatment to address these factors and improve public health outcomes. Overall, from a public health perspective, making naloxone available OTC can be an effective strategy for reducing the harm caused by opioid overdoses.

According to the World Health Organization, the circumstances in which people are born, develop, live, work, and age have a direct impact on their health outcomes.19 These can vary greatly depending on aspects including race, ethnicity, socioeconomic position, and geography, and are frequently influenced by social, economic, and political variables; especially as it relates to substance abuse therapy.

The stigma surrounding people who use drugs is a factor within the societal level of the social-ecological model that maps the social determinants of health and might influence a person's substance use. The initial perception may be that naloxone use during an overdose encourages those with substance use disorder to continue consuming and the idea may be that easy access to naloxone will discourage those same people from getting the treatment they need. To eliminate the existing stigma in the community, addiction must be recognized as a treatable condition rather than an immoral act. The negative perception and embarrassment associated with addiction are among the most significant obstacles that can leave addiction untreated, leading to severe health consequences.

After naloxone OTC approval, certain resources can be used to make its use more effective and reduce overdose deaths. Pharmacies, schools, pharmaceutical companies, and health insurance plans can spread awareness of the current opioid epidemic in the United States by offering national campaigns that include posters and video demonstrations to offer education to the community in different modalities. Avoidable deaths can be prevented by educating individuals with OUT on the signs of an overdose and demonstrating how to easily administer naloxone.

One key step is to provide access to helplines that can offer guidance and assistance to both patients and caregivers on how to seek help and access appropriate treatment. At a federal level, naloxone can be labeled as medically necessary and required to be sold at the lowest possible price and to be fully covered on all insurance companies’ formularies. Implementing regulations to facilitate access to naloxone will avoid inflation of the product and insurance companies not wanting to cover its cost.

Although naloxone is easy to use, the layperson may not feel comfortable administering the product due to a lack of knowledge or fear. Advertisements should be placed next to the OTC product with simple easy to read instructions, in the form of pictures, a sign poster, and a QR code that will allow the public to watch a short video on how to use it. Recommendations can be made to all nightlife facilities such as restaurants, bars, and nightclubs to implement mandatory training for staff on administration of naloxone and signs of an overdose. Additionally, carrying a minimum of 2 naloxone per location inside their first aid kits can be very helpful in case of an emergency. Training should be implemented into health care students' curriculum, so professionals are better equipped and comfortable to use the medication and teach the public. Thus, changing the stigma surrounding opioid overdose on a national scale.

References

1. FDA approves first over-the-counter naloxone nasal spray, U.S. Food and Drug Administration. FDA. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray (Accessed: April 6, 2023).

2. Whitehouse S. Text - S.524 - 114th Congress (2015-2016): Comprehensive Addiction and Recovery Act of 2016. www.congress.gov. Published July 22, 2016. https://www.congress.gov/bill/114th-congress/senate-bill/524/text

3. The 2022 Florida Statutes 381.887 Emergency treatment for suspected opioid overdose (2022) Statutes & constitution :view statutes : Online sunshine. Available at: http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute (Accessed: April 6, 2023).

4. Rule 64B16-27.800 Requirement for Patient Records. (2015) Florida Administrative Rules, Law, Code, Register - FAC, FAR, eRulemaking. Available at: https://www.flrules.org/ (Accessed: April 6, 2023).

5. Roberts AW, Carpenter DM, Smith A, Look KA. Reviewing state-mandated training requirements for naloxone-dispensing pharmacists. Res Social Adm Pharm. 2019;15(2):222-225. doi:10.1016/j.sapharm.2018.04.002

6. Kosobuski L, O'Donnell C, Koh-Knox Sharp CP, Chen N, Palombi L. The Role of the Pharmacist in Combating the Opioid Crisis: An Update. Subst Abuse Rehabil. 2022;13:127-138. Published 2022 Dec 28. doi:10.2147/SAR.S351096

7. The 2022 Florida Statutes 768.13, Good Samaritan Act; immunity from civil liability. (6AD) Welcome : Online Sunshine. Available at: http://www.leg.state.fl.us/ (Accessed: April 6, 2023).

8. Bessen, S., Metcalf, S. A., Saunders, E. C., Moore, S. K., Meier, A., McLeman, B., ... & Marsch, L. A. (2019). Barriers to naloxone use and acceptance among opioid users, first responders, and emergency department providers in New Hampshire, USA. International Journal of Drug Policy, 74, 144-151.

9. Cernasev A, Veve MP, Talbott T, Hall EA, Hohmeier KC. Pharmacy Students' Perceptions and Stigma Surrounding Naloxone Use in Patients with Opioid Use Disorder: A Mixed Methods Evaluation. Pharmacy (Basel). 2020;8(4):205. Published 2020 Nov 3. doi:10.3390/pharmacy8040205

10. Thakur T, Frey M, Chewning B. Evaluating Pharmacy Student Consultations with Standardized Patients on Opioid Medication Use and Opioid-Specific Risks. Am J Pharm Educ. 2019;83(10):7494. doi:10.5688/ajpe7494

11. Lai RK, Friedson KE, Reveles KR, et al. Naloxone accessibility without an outside prescription from U.S. community pharmacies: A systematic review. J Am Pharm Assoc (2003). 2022;62(6):1725-1740. doi:10.1016/j.japh.2022.07.008

12. Evoy KE, Hill LG, Davis CS. Considering the Potential Benefits of Over-the-Counter Naloxone. Integr Pharm Res Pract. 2021;10:13-21. Published 2021 Feb 15. doi:10.2147/IPRP.S244709

13. Bohler RM, Freeman PR, Villani J, Hunt T, Linas BS, Walley AY, Green TC, Lofwall MR, Bridden C, Frazier LA, Fanucchi LC, Talbert JC, Chandler R. The policy landscape for naloxone distribution in four states highly impacted by fatal opioid overdoses. Drug Alcohol Depend Rep. 2023 Mar;6:100126. doi: 10.1016/j.dadr.2022.100126. Epub 2022 Dec 5. PMID: 36643788; PMCID: PMC9838196.

14. Peet ED, Powell D, Pacula RL. Trends in Out-of-Pocket Costs for Naloxone by Drug Brand and Payer in the US, 2010-2018. JAMA Health Forum. 2022 Aug 5;3(8):e222663. doi: 10.1001/jamahealthforum.2022.2663. Erratum in: JAMA Health Forum. 2022 Dec 2;3(12):e224857. PMID: 36200636; PMCID: PMC9391964.

15. Barenie RE, Gagne JJ, Kesselheim AS, et al. Rates and Costs of Dispensing Naloxone to Patients at High Risk for Opioid Overdose in the United States, 2014-2018. Drug Saf. 2020;43(7):669-675. doi:10.1007/s40264-020-00923-6

16. Lai JT, Goldfine CE, Chapman BP, et al. Nobody Wants to Be Narcan'd: A Pilot Qualitative Analysis of Drug Users' Perspectives on Naloxone. West J Emerg Med. 2021;22(2):339-345. Published 2021 Feb 8. doi:10.5811/westjem.2020.10.48768

17. Anna Kline, Dina Mattern, Nina Cooperman, Patricia Dooley-Budsock, Jill M. Williams & Suzanne Borys (2020) “A Blessing and a Curse:” Opioid Users' Perspectives on Naloxone and the Epidemic of Opioid Overdose, Substance Use & Misuse, 55:8, 1280-1287, DOI: 10.1080/10826084.2020.1735437

18. NIDA. 2017, March 30. Naloxone for Opioid Overdose: Life-Saving Science. Retrieved from http://nida.nih.gov/publications/naloxone-opioid-overdose-life-saving-science on 2023, April 13

19. Social Determinants of Health. World Health Organization. https://www.who.int/health-topics/social-determinants-of-health#tab=tab_1. Accessed April 26, 2023.

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