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Manuscript Information Journal name: Journal of the American Pharmacists Association : JAPhA NIHMS ID: NIHMS851098 Manuscript Title:Non-Prescription Naloxone and Syringe Sales in the Midst of Opioid Overdose and Hepatitis C Virus Epidemics: Massachusetts, 2015 Submitter: Author support, Elsevier ([email protected])

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    Non-Prescription Naloxone and Syringe Sales in the Midst of Opioid Overdose and Hepatitis C Virus Epidemics: Massachusetts, 2015 Thomas J. Stopka PhD, MHS, Ashley Donahue MPH, Marguerite Hutcheson MA, Traci C. Green PhD, MSc PII: DOI: Reference:

S1544-3191(16)31026-3 doi:10.1016/j.japh.2016.12.077 JAPH 232

Published in:

Journal of the American Pharmacists Association

Received date: Revised date: Accepted date:

6 September 2016 22 December 2016 22 December 2016

Cite this article as: Stopka TJ, Donahue A, Hutcheson M, Green TC, Non-Prescription Naloxone and Syringe Sales in the Midst of Opioid Overdose and Hepatitis C Virus Epidemics: Massachusetts, 2015, Journal of the American Pharmacists Association, doi:10.1016/j.japh.2016.12.077

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c 2016 American Pharmacists Association. Published by Elsevier Inc. 

Non-Prescription Naloxone and Syringe Sales in the Midst of Opioid Overdose and Hepatitis C Virus Epidemics: Massachusetts, 2015 Thomas J. Stopka1, PhD, MHS, Ashley Donahue1, MPH, Marguerite Hutcheson1, MA, Traci C. Green2, PhD, MSc 1

Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston Massachusetts 2 School of Medicine, Boston University, Boston Massachusetts; Boston Medical Center Injury Prevention Center http://www.japha.org/content/authorinfo#idp1192928 The authors declare no conflicts of interest. Corresponding Author: Thomas J. Stopka, PhD, MHS Assistant Professor Department of Public Health and Community Medicine & Tufts Clinical and Translational Science Institute (CTSI) Tufts University School of Medicine 136 Harrison Avenue, MV 244 Boston, MA 02111 Phone: (617) 636-2110 Fax: (617) 636-4017 [email protected]

Abstract: 298 Keywords: 5 Word Count: 3,664 Number of Tables and Figures: 4 tables; 2 figures Number of References: 63

Non-prescription Naloxone and Syringe Sales in the Midst of Opioid Overdose and Hepatitis C Virus Epidemics: Massachusetts, 2015 Abstract Objectives: To determine the prevalence of non-prescription naloxone and sterile syringe sales, factors associated with non-prescription sales, geospatial access to non-prescription naloxone and syringe selling pharmacies, and targets for potential interventions. Design: Cross-sectional study. Setting and Participants: Massachusetts has experienced steep increases in reported opioid overdoses and hepatitis C virus (HCV) cases in the past decade. Pharmacists have the potential to play a substantial role in increasing access to non-prescription naloxone and sterile syringes, which can reverse opioid overdoses and decrease HCV transmission, respectively. We completed brief telephone surveys with 809 of 1,042 retail pharmacies across Massachusetts (response rate=77.6%) during 2015 to assess experience with non-prescription sales of naloxone and sterile syringes. Outcome Measures: Our primary outcomes were the stocking and selling of naloxone in the pharmacy (yes/no) for non-prescription sales, and non-prescription syringe sales (yes/no). We conducted multivariable regression analyses and created maps using a geographic information system (GIS) to identify factors associated with non-prescription sales of naloxone and sterile syringes, and to improve our understanding geospatial access to pharmacy-based naloxone and syringe sales. Results: Over 97% of pharmacies reported selling sterile syringes without requiring a prescription and 45% of pharmacies reported stocking and selling naloxone. Factors associated with non-prescription sales included: hours of operation, experience with and interest in harm reduction activities, and presence in an opioid overdose hotspot. Geographic access to non-prescription sale of sterile syringes is wide-spread, while geospatial access to naloxone is more limited. Training to better understand the benefits, applications, and distribution needs of naloxone is of interest to surveyed pharmacists.

Conclusion: Access to sterile syringes through non-prescription sales is strong across Massachusetts and, while over 350 pharmacies (45%) reported stocking and selling naloxone to prevent opioid overdose deaths, there is much room for improvement in access, and training among pharmacy staff. Keywords: Pharmacy, naloxone sales, non-prescription syringe sales, HCV prevention, overdose prevention

Background The opioid epidemic has become an increasing challenge to families, communities, pharmacies, public health departments, and clinicians. Opioid mortality rates have increased significantly during the past decade across the U.S.1,2 In Massachusetts, opioid overdose-related deaths have increased precipitously, from 338 in 2000 to an estimated 1,747 in 2016.3 Approximately 184 million people are currently infected with the hepatitis C virus (HCV) worldwide.4,5 In the U.S., approximately 3.2 million people are estimated to be living with HCV and about two-thirds of HCV transmissions in the U.S. are attributed to injection drug use, with an increasing burden among young people who inject drugs (PWID).6-9 The HCV epidemic in Massachusetts presents a major public health crisis, where the Massachusetts Department of Public Health (MDPH) found that the number of reported HCV cases in the 15-24-year-old population increased by 78% between 2002 and 2009, and reported HCV cases increased by 137% among 15-29 year-olds between 2002 and 2013.7-9 This increase in HCV may impact health care costs: due to the extremely high cost of new HCV treatments, several states have limited the coverage of these treatments in their Medicaid programs.10 In many locations across the globe, pharmacies are increasingly considered as locales where PWID can receive important public health services.11 Pharmacists are viewed as one of the most accessible healthcare providers for PWID.12 More than 1,000 retail pharmacies are licensed in Massachusetts and stand as key players in the fight against injection-mediated disease risks and opioid overdose outcomes. Increasingly, pharmacies are being called upon to provide public health services to their customers and the surrounding community, but pharmacists have expressed concerns about their own training and competence to provide public health services, and with providing PWID with sterile syringes13 Nevertheless, since the early 1990’s, a number of U.S. states introduced legislation to permit non-prescription sales of syringes in pharmacies.14-25 Subsequently, pharmacy syringe sales have been associated with reduced injection mediated-risks14,26-28 and reduced rates of HIV infection among PWID.29-31 Non-prescription syringe sales offer the potential for enhancing syringe availability due to the broad distribution of pharmacies throughout most regions of the U.S. and up to 24 hours of operation,27,32 but syringe sales rates can vary substantially, depending on local legislation and local

pharmacy practice.33 In many states, PWID recognize pharmacies as stable, safe and affordable sources of sterile syringes,19,34,35 and other services, depending on the training level of the pharmacists.36 A large percentage of pharmacists have agreed to sell non-prescription syringes across the U.S.16,18,20,37,38 Naloxone is a medication that can reverse opioid-induced overdoses and is available in the U.S. for layperson use in intramuscular and intranasal formulations. Access to naloxone has become a key tool in local, state, and national efforts to curb opioid-related overdoses.39 Through standing orders, collaborative practice agreements, and prescriptive authority, states have created an environment that simulates non-prescription pharmacy naloxone access, though the formal, FDA-approved process of non-prescription designation has not been conferred on any naloxone products to date.40 Such pharmacy naloxone access models have been legalized in an increasing number of states across the U.S and improve access in the absence of freely available non-prescription naloxone sales.39 For ease of discussion, this paper will refer to access through standing orders as non-prescription naloxone, to permit discussions of both syringes and expanded pharmacy naloxone access. Recent studies in New England have found that pharmacy sales of naloxone are feasible from both the pharmacists and PWID perspective.41 The feasibility of pharmacy-based naloxone distribution interventions has been explored through qualitative studies with injection drug users and pharmacy staff in Rhode Island,41 but there are several legal considerations that can hinder or facilitate implementation of such programs.42 Increasing access to the naloxone medication is an effective and cost-effective method of reducing opioid overdose deaths. Local legislation is a key factor in the evolution of naloxone access initiatives, and a number of lessons learned have been garnered from previous work in Massachusetts and North Carolina, to offer a roadmap for future action.42 Geographic information systems (GIS) and spatial epidemiology facilitate mapping and analysis of geographically-oriented health data43 like access to non-prescription naloxone in the community, on a local neighborhood level, and access to important public health and clinical services. GIS and spatial epidemiological analyses have been used increasingly in recent years to assess the risk environment in local communities with regard to syringe access,44,45 infectious disease,46 and unmet public health needs.47

Few studies have looked at current non-prescription naloxone and sterile syringe sales practices in retail pharmacies in the U.S. In Massachusetts, where the intertwined opioid and HCV epidemics have increased significantly, a better understanding of the actual and potential role of pharmacies as public health agents is sorely needed. In the current study, we conducted a phone-based survey with retail pharmacies across Massachusetts and mapped retail pharmacies across the state to learn about local sales practices, the geographic distribution of access points, needs for local training opportunities, and knowledge about programs that can facilitate sales and distribution of important harm reduction services to communities, family members, and friends who may need them most.

Methods Questionnaire Development We developed a telephone-based survey based on our previous work and evidence from the literature regarding non-prescription sales of harm reduction products in retail pharmacies. Our overall goal was to determine current non-prescription sales practices related to the sale of naloxone and sterile syringes, in order to determine the public health role of local pharmacies in reducing injection-mediated risks related to infectious disease transmission and opioid overdose prevention. We developed survey questions from several domains: pharmacy syringe access, overdose prevention, local pharmacy knowledge and practices. The structured questionnaire was designed to be answered by pharmacists, pharmacy managers, or pharmacy technicians, to take between three and five minutes, and to focus on: (1) Pharmacy characteristics (e.g., address, chain vs. independent, days/hours of operation); (2) non-prescription naloxone sales experience and knowledge of state naloxone law and regulation; (3) non-prescription syringe sales experiences; and, (4) drug disposal options at the pharmacy. Questions about pricing, sales quantities, sales refusal rates, and challenges with sales were also included. To complete the questionnaire in less than five minutes, survey questions were primarily multiple choice and skip patterns were embedded, where participants were asked up to 28 questions in total based on their responses. Once finalized for inclusion in the survey, questions were programmed into, collected, and managed using REDCap Electronic data capture tools hosted at Tufts University Clinical and Translational Science Institute

(CTSI).48 The RedCap survey tool facilitated the time-efficient completion of this phone-based survey of mostly multiple choice or short answer questions. Survey sample We obtained a list of all licensed retail pharmacies from the Massachusetts State Board of Pharmacy. In 2015, at the time of the survey, 1,057 pharmacies were listed as licensed retail pharmacies in Massachusetts. Fifteen pharmacies were excluded from the original list as five pharmacies were permanently closed, five were not retail pharmacies, and five represented duplicate values. A final list of retail pharmacies (n=1042) was deemed eligible for follow-up contact. Data collection From January to July 2015, the 1042 eligible retail pharmacies in Massachusetts were called at least twice to garner their interest in survey participation. Before asking for verbal consent, the pharmacy staff were briefed that the telephone survey was anonymous and the study staff were interested in learning about harm reduction services available at their pharmacy. To maximize response rates, we gave pharmacy staff the option to complete the survey over the phone, through a faxed paper copy, online, or via an emailed web-link to the REDCap version of the survey. Data analysis We calculated frequencies, proportions, and measures of central tendencies for all survey response options to determine the statistical distribution of responses and establish cut points for subsequent analyses. We also determined the population distribution by Massachusetts counties using census estimates from the American Community Survey49 to compare response rates by county to population proportions by county. We conducted Chi-square, Fisher’s exact, and student t-tests to compare measures between responding and nonresponding pharmacies, as well as non-prescription sales characteristics for naloxone and sterile syringes. Next, we conducted bivariate and multivariable logistic regression analyses to determine factors associated with nonprescription syringe and naloxone sales. We included variables that were significant at a p