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      Will converting naloxone to over‐the‐counter status increase pharmacy sales?

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          Abstract

          Objective

          To estimate the own‐price elasticity of demand for naloxone, a prescription medication that can counter the effects of an opioid overdose, and predict the change in pharmacy sales following a conversion to over‐the‐counter status.

          Data Sources/Study Setting

          The primary data source was a nationwide prescription claims dataset for 2010‐2017. The data cover 80 percent of US retail pharmacies and account for roughly 90 percent of prescriptions filled. Additional covariates were obtained from various secondary data sources.

          Study Design

          We estimated a longitudinal, simultaneous equation model of naloxone supply and demand. Our primary variables of interest were the quantity of naloxone sold, measured as total milligrams sold at pharmacies, and the out‐of‐pocket price paid per milligram, both measured per ZIP Code and quarter‐year.

          Data Collection/Extraction Methods

          Primary data came directly from payers and processors of prescription drug claims.

          Principal Findings

          We found that, on average, a 1 percent increase in the out‐of‐pocket price paid for naloxone would result in a 0.27 percent decrease in pharmacy sales. We predict that the total quantity of naloxone sold in pharmacies would increase 15 percent to 179 percent following conversion to over‐the‐counter status.

          Conclusions

          Naloxone is own‐price inelastic, and conversion to over‐the‐counter status is likely to lead to a substantial increase in total pharmacy sales.

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          Most cited references19

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          Opioid Overdose Prevention Programs Providing Naloxone to Laypersons — United States, 2014

          Drug overdose deaths in the United States have more than doubled since 1999 (1). During 2013, 43,982 drug overdose deaths (unintentional, intentional [suicide or homicide], or undetermined intent) were reported (1). Among these, 16,235 (37%) were associated with prescription opioid analgesics (e.g., oxycodone and hydrocodone) and 8,257 (19%) with heroin (2). For many years, community-based programs have offered opioid overdose prevention services to laypersons who might witness an overdose, including persons who use drugs, their families and friends, and service providers. Since 1996, an increasing number of programs provide laypersons with training and kits containing the opioid antagonist naloxone hydrochloride (naloxone) to reverse the potentially fatal respiratory depression caused by heroin and other opioids (3). In July 2014, the Harm Reduction Coalition (HRC), a national advocacy and capacity-building organization, surveyed 140 managers of organizations in the United States known to provide naloxone kits to laypersons. Managers at 136 organizations completed the survey, reporting on the amount of naloxone distributed, overdose reversals by bystanders, and other program data for 644 sites that were providing nalox-one kits to laypersons as of June 2014. From 1996 through June 2014, surveyed organizations provided naloxone kits to 152,283 laypersons and received reports of 26,463 overdose reversals. Providing opioid overdose training and naloxone kits to laypersons who might witness an opioid overdose can help reduce opioid overdose mortality. Since 2008, HRC has maintained a database of organizations providing naloxone kits to laypersons. The Opioid Safety and Naloxone Network is a national network of naloxone experts, program administrators, and advocates. Before the survey, HRC staff polled network participants for information on any new organizations providing naloxone kits to laypersons that should be included in the survey. In July 2014, HRC e-mailed a link to an online survey to managers of 140 organizations known to provide naloxone kits to laypersons. These organizations included public health departments, pharmacies, health care facilities, substance use treatment facilities, and community-based organizations providing services to persons who use drugs, including current or former opioid (heroin or pharmaceutical) users, and other potential witnesses to overdoses. Law enforcement organizations, emergency medical services, and other professional first responders using naloxone were not included in this survey. The survey included questions about the year the organization began operating; the numbers of sites or local programs providing naloxone kits; the number of persons trained in overdose prevention and provided naloxone kits; and the number of reports of overdose reversals (administration of naloxone by a trained layperson in the event of an overdose) (4), as well as whether the reports were based on program data or were estimates. The survey also asked about the naloxone formulations currently provided in kits, models for training and providing naloxone kits, funding sources, and any difficulties obtaining naloxone. To obtain data for a recent full calendar year, organizations providing naloxone kits during calendar year 2013 were asked to provide specific data for that year, including numbers of persons provided naloxone kits, reversals reported, and naloxone vials provided; characteristics of persons who received naloxone kits (e.g., persons who use drugs, friends and family members, service providers); characteristics of persons reporting overdose reversals; and the drugs involved in reported overdose reversals. HRC staff used follow-up e-mails and telephone calls to encourage participation and clarify responses. Managers from 136 (97.1%) organizations completed the survey, including those from 84 community-based organizations, 18 health care facilities, 10 Veterans Administration health care systems, 18 state or local health departments, and six pharmacies. Half of the responding organizations began operating during January 2013–June 2014 (Figure 1). Respondents provided reports for 644 local opioid overdose prevention sites that provide naloxone kits, located in 30 states and the District of Columbia (DC) (Figure 2). Thirty-eight respondents provided consolidated data for multiple local sites providing naloxone kits. Some organizations estimated responses; for example, one health department estimated the number of laypersons receiving naloxone kits on the basis of the number of kits distributed to local sites. Three state health departments (Massachusetts, New Mexico, and New York) oversee operations of statewide naloxone programs, with 334 local sites (51.9% of the 644 local sites). From 1996, when the first organization began providing naloxone, through June 2014, the 136 responding organizations reported providing training and naloxone kits to 152,283 laypersons (range = 1–36,450; median = 100; mean = 1,120).* The 109 organizations that collect reports of reversals documented 26,463 overdose reversals (range = 0–5,430; median = 9; mean = 243).† During 2013, 93 organizations reported distributing or prescribing naloxone to 37,920 laypersons (range = 0–9,000; median = 75; mean = 407.7).§ The 68 (50%) organizations that collect reports of reversals documented 8,032 overdose reversals (range = 0–2,079; median = 10; mean = 118.1).¶ Ninety-three organizations collected information on the characteristics of laypersons who were provided naloxone kits. Laypersons who received naloxone kits were characterized as persons who use drugs (81.6%); friends and family members (11.7%); service providers (3.3%); or unknown (3.4%).** Sixty-eight organizations provided information about lay-persons who reported administering naloxone, characterizing them as persons who use drugs (82.8%); friends and family members (9.6%); service providers (0.2%); or unknown (7.4%).†† Forty-two organizations collected information from laypersons about the drugs that appeared to be involved in the reversed overdoses; heroin was involved in 81.6% and prescription opioids in 14.1%.§§ Various program models were used by organizations to provide naloxone to laypersons, including distribution of naloxone kits by trained nonmedical staff or volunteers under a standing order (60 [44.1%]), by medical staff (49 [36.0%]), prescriptions written by a medical provider and filled at a pharmacy (39 [28.7%]), pharmacists dispensing directly via collaborative practice agreements and other mechanisms (12 [8.8%]), and other protocols (19 [14.0%]). Thirty-three organizations used more than one model. During 2013, 90 (66.2%) of the 136 organizations reported distributing 140,053 naloxone vials, including refills (range = 1–53,200; median = 179.5; mean = 1,556.1).¶¶ Three respondents whose organizations were operational in 2013 did not report on the number of vials because they furnished prescriptions to be filled at a pharmacy. The remaining 43 organizations indicated that they were not yet providing naloxone kits during 2013. Sixty-nine respondents (50.7%) reported their organization provided only injectable naloxone, 51 (37.5%) provided only intranasal naloxone, and 16 (11.8%) provided both injectable and intranasal naloxone.*** A total of 111,602 vials (79.7%) of injectable naloxone (21.4% 10 mL and 58.1% 1 mL) and 28,446 (20.3%) vials of intranasal naloxone were provided to laypersons. Organizations were characterized as small, medium, large, or very large, on the basis of the number of naloxone vials distributed during 2013. The 11 large and very large organizations provided naloxone to 28,604 laypersons, representing 75.4% of all 2013 recipients (Table). Forty (29.4%) organizations reported difficulties maintaining an adequate supply of naloxone, and 73 (53.7%) reported inadequate resources to sustain or expand their organization’s efforts to disseminate naloxone kits. Discussion Organizations that provide naloxone kits to laypersons have expanded substantially since a similar survey in 2010 (5), reflecting a 183% (from 48 to 136) increase in the number of responding organizations; a 243% (from 188 to 644) increase in the number of local sites providing naloxone; a 187% (from 53,032 to 152,283) increase in the number of laypersons provided naloxone kits; a 160% (from 10,171 to 26,463) increase in the number of reversals reported; and a 94% (from 16 to 30) increase in states (including DC) with at least one organization providing naloxone. Half of the responding organizations began operating during January 2013–June 2014. Although early adopters of naloxone kit provision were mainly syringe exchanges, other programs, including substance use treatment facilities, Veterans Administration health care systems, primary care clinics, and pharmacies have started providing naloxone to laypersons. Providing naloxone kits to laypersons reduces overdose deaths (4), is safe (3), and is cost-effective (6). U.S. and international health organizations recommend providing naloxone kits to laypersons who might witness an opioid overdose (3,7); to patients in substance use treatment programs (3,7,8); to persons leaving prison and jail (3,7,8); and as a component of responsible opioid prescribing (8). Although the number of organizations providing naloxone kits to laypersons is increasing, in 2013, 20 states had no such organization, and nine had less than one layperson per 100,000 population who had received a naloxone kit. Among these 29 states with minimal or no access to naloxone kits for laypersons, 11 had age-adjusted 2013 drug overdose death rates higher than the national median (2). Some organizations reported information on the laypersons receiving naloxone kits (N = 99 organizations), using naloxone in overdose reversals (N = 68), and the drugs that appeared to have caused the overdose (N = 42). Persons who use drugs accounted for 81.6% of laypersons who received naloxone kits; they also performed the majority (82.8%) of reported overdose reversals. A majority (81.6%) of the overdoses that were reversed involved heroin, indicating that organizations are reaching laypersons who witness heroin overdoses. A study of a community-based naloxone program in San Francisco also found that persons who use drugs play a major role in reversing heroin overdoses (9). Additional interventions are needed to reach persons who may witness prescription opioid analgesic overdoses, which account for nearly twice as many deaths as heroin overdoses. Forty (29.4%) respondents reported that their organization has experienced problems obtaining naloxone. Prices of intranasal naloxone more than doubled in the second half of 2014 (10) and Opioid Safety and Naloxone Network members report that cost increases are reducing the quantity of naloxone purchased and provided to laypersons (Matt Curtis, VOCAL NY, personal communication, 2015). The findings in this report are subject to at least four limitations. First, despite extensive knowledge of naloxone distribution programs by the Harm Reduction Coalition and Opioid Safety and Naloxone Network, organizations providing naloxone kits are increasing rapidly and some might not yet be known to HRC and therefore, might not be included in the survey, which may underestimate the impact of these programs. Second, survey responses are based on unconfirmed reports from organizations providing naloxone kits. Third, some reports provided by organizations are based on estimates. These three limitations could result in either under or over-reporting of persons provided naloxone kits. Finally, the numbers of overdose reversals likely were under-reported, because some sites, such as pharmacies, do not collect reversal reports. Organizations providing naloxone kits to laypersons receive many reports of overdose reversals and can reach large numbers of potential overdose bystanders. Comprehensive prevention measures that include teaching laypersons how to respond to overdoses and administer naloxone might help prevent opioid drug overdose deaths. This report suggests that many programs reach persons who witness heroin-related overdoses; additional methods are needed to provide naloxone kits to persons who might witness prescription opioid analgesic overdoses. Summary What is already known on this topic? Drug overdose deaths in the United States have more than doubled since 1999, reaching a total of 43,982 in 2013. Heroin and prescription opioids are major causes of drug overdose deaths. Naloxone is the standard medication used for reversal of the potentially fatal respiratory depression caused by opioid overdose. What is added by this report? From 1996 through June 2014, a total of 644 local sites in 30 states and the District of Columbia reported providing naloxone kits to 152,283 laypersons and receiving reports of 26,463 drug overdose reversals using naloxone from 1996 through June 2014. Most laypersons who reported using the kits to reverse an overdose were persons who use drugs, and many of the reported reversals involved heroin overdoses. Medical clinics and pharmacies have started providing naloxone kits to laypersons, and the reported number of organizations providing kits almost doubled from January 2013 through June 2014. What are the implications for public health practice? Organizations training and providing naloxone kits to laypersons can reach large numbers of potential overdose witnesses and result in many reported overdose reversals. Comprehensive prevention measures that include teaching laypersons how to respond to overdoses and administer naloxone prevent opioid-related drug overdose deaths. Additional methods are needed to provide naloxone kits to persons who might witness prescription opioid analgesic overdoses.
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            Review of naloxone safety for opioid overdose: practical considerations for new technology and expanded public access.

            Opioid overdose and mortality have increased at an alarming rate prompting new public health initiatives to reduce drug poisoning. One initiative is to expand access to the opioid antidote naloxone. Naloxone has a long history of safe and effective use by organized healthcare systems and providers in the treatment of opioid overdose by paramedics/emergency medicine technicians, emergency medicine physicians and anesthesiologists. The safety of naloxone in a prehospital setting administered by nonhealthcare professionals has not been formally established but will likely parallel medically supervised experiences. Naloxone dose and route of administration can produce variable intensity of potential adverse reactions and opioid withdrawal symptoms: intravenous administration and higher doses produce more adverse events and more severe withdrawal symptoms in those individuals who are opioid dependent. More serious adverse reactions after naloxone administration occur rarely and may be confounded by the effects of other co-intoxicants and the effects of prolonged hypoxia. One component of the new opioid harm reduction initiative is to expand naloxone access to high-risk individuals (addicts, abusers, or patients taking high-dose or extended-release opioids for pain) and their close family or household contacts. Patients or their close contacts receive a naloxone prescription to have the medication on their person or in the home for use during an emergency. Contacts are trained on overdose recognition, rescue breathing and administration of naloxone by intramuscular injection or nasal spraying of the injection prior to the arrival of emergency medical personnel. The safety profile of naloxone in traditional medical use must be considered in this new context of outpatient prescribing, dispensing and treatment of overdose prior to paramedic arrival. New naloxone delivery products are being developed for this prehospital application of naloxone in treatment of opioid overdose and prevention of opioid-induced mortality.
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              Perpetuating stigma or reducing risk? Perspectives from naloxone consumers and pharmacists on pharmacy-based naloxone in 2 states.

              Little is known about attitudes of pharmacists and consumers to pharmacy naloxone. We examined perceptions and experiences of pharmacy naloxone from people with opioid use disorder, patients taking chronic opioids for pain, caregivers of opioid users, and pharmacists from 2 early pharmacy naloxone adopter states: Massachusetts and Rhode Island.
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                Author and article information

                Contributors
                smm2010@med.cornell.edu
                Journal
                Health Serv Res
                Health Serv Res
                10.1111/(ISSN)1475-6773
                HESR
                Health Services Research
                John Wiley and Sons Inc. (Hoboken )
                0017-9124
                1475-6773
                20 February 2019
                August 2019
                : 54
                : 4 ( doiID: 10.1111/hesr.2019.54.issue-4 )
                : 764-772
                Affiliations
                [ 1 ] Department of Healthcare Policy & Research Weill Cornell Medical College New York New York
                [ 2 ] Department of Health Law, Policy & Management Boston University School of Public Health Boston Massachusetts
                Author notes
                [*] [* ] Correspondence

                Sean M. Murphy, PhD, Department of Healthcare Policy & Research, Cornell University Joan and Sanford I Weill Medical College, New York, NY.

                Email: smm2010@ 123456med.cornell.edu

                Author information
                https://orcid.org/0000-0001-9104-0670
                https://orcid.org/0000-0002-1559-3983
                https://orcid.org/0000-0002-8336-5536
                https://orcid.org/0000-0002-1132-2932
                Article
                HESR13125
                10.1111/1475-6773.13125
                6606536
                30790269
                2b9ab975-5ad8-4935-ba06-8fd28eb3debe
                © 2019 The Authors. Health Services Research published by Wiley Periodicals, Inc. on behalf of Health Research and Educational Trust

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                Page count
                Figures: 1, Tables: 3, Pages: 9, Words: 6755
                Funding
                Funded by: National Institute on Drug Abuse , open-funder-registry 10.13039/100000026;
                Award ID: P30DA040500
                Categories
                Research Article
                Health Care Utilization and Cost
                Custom metadata
                2.0
                August 2019
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.2 mode:remove_FC converted:05.12.2019

                Health & Social care
                change in demand,naloxone,opioid overdose,over‐the‐counter conversion
                Health & Social care
                change in demand, naloxone, opioid overdose, over‐the‐counter conversion

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