Barriers to Access: Exploring Factors that Inhibit Use of. Over-The-Counter Pharmacy Sales. as a Source of Sterile Needles and Syringes

Transcription

1 Barriers to Access: Exploring Factors that Inhibit Use of Over-The-Counter Pharmacy Sales as a Source of Sterile Needles and Syringes PADM 659 Capstone Project University of Alaska --- Anchorage Masters of Public Administration Program April 18th, 2014

2 Executive Summary Barriers to Access: Exploring Factors that Inhibit Use of Over-The-Counter The Alaska HIV Planning Group (HPG) is exploring the potential for expanding needle and syringe access in the state as a means of reducing transmission of hepatitis C and HIV. In order to inform planning decisions, published information on the topic of over-the-counter sales of sterile needles and syringes was reviewed. Barriers to pharmacy sales of NS were compiled and explored. Supplemental information was captured through a series of exploratory key informant interviews with Alaskan stakeholders, including law enforcement, elected officials, and governmental and community organizations. After synthesis of all barriers to access recognized through these investigatory methodologies, it is recommended that the Alaska HIV Planning Group (HPG): educate stakeholders about the goals and functions of any pharmacy-sales based needle expansion program and the health benefits of increasing sterile needle access; test the viability for this type of program by attempting a pilot-level effort toward encouraging NS pharmacy sales; integrate input from all of the community stakeholders into programmatic efforts; integrate needle discard and safe disposal methods into programmatic efforts; consider advocating for greater clarity regarding the legality of this approach where possible and beneficial; remain open to other methodologies for needle access expansion in addition to over-the-counter pharmaceutical sales; and invest in additional research that explores this issue in an Alaska-specific context. 1

3 Table of Contents Executive Summary... 1 Table of Contents... 2 Introduction... 4 Background... 5 General approaches to expanding sterile needle access:... 5 Syringe exchange programs:... 6 Pharmaceutical sales:... 7 Vending machines: Basic distribution and provision methods: Mobile vans or outreach needle exchange: Supervised injection facilities: Facilitation of street sales: Comparison of known methodologies: Information about Alaska s Current Efforts: HIV statistics for the state: Estimates of drug activity in Alaska: Funding restrictions for programmatic response: Current efforts to reduce HIV transmission: Methodology Primary Methodology: Literature Review Secondary methodology: Key informant interviews

4 Results Barriers recognized in the general literature: Structural barriers: Barriers for intravenous drug users: Barriers for pharmacists: Barriers for the law enforcement community: Barriers for the elected official community: Barriers for government and community organizations: Barriers for the General Public: Recognized Barriers in the State of Alaska Structural barriers: Barriers for intravenous drug users: Barriers for pharmacists: Stakeholder perspectives and barriers for the law enforcement community: Stakeholder perspectives and barriers for the elected official community: Stakeholder perspectives and barriers for government and community organizations: Discussion and Recommendations Conclusions

5 Introduction Barriers to Access: Exploring Factors that Inhibit Use of Over-The-Counter Injection drug use is recognized by the public health community as a major factor in the transmission of blood-borne diseases, including HIV and hepatitis C (HCV). Estimates of drug use indicate that between 11 and 21 million people worldwide are injection drug users. Of these, around 10 million are estimated to have contracted hepatitis C, and around 3 million are estimated to be living with HIV (Macarthur et. al., 2014). Intravenous drug users (IDUs) can reduce their probability of exposure to disease by using clean injection equipment and abstaining from needle reuse or sharing. These risk-reduction behaviors are promoted in part by needle distribution or supplemental access to sterile injection supplies (Janulis, 2012). In the effort towards reducing disease transmission, a number of different modalities aimed at increasing IDU access to clean needles and syringes (NS) have been developed over time. The Alaska HIV Planning Group (HPG) is beginning to explore the potential for expanding needle and syringe access in the state as a means of reducing transmission of HIV and HCV. Legal limitations applied to the dissemination of federal funds restrict these monies from financially augmenting syringe exchange programs, the predominant methodology for increasing sterile NS access. As a result, alternate approaches towards expanding sterile needle access must be considered if utilization of State disseminated funding is desired. In order to inform potential programmatic efforts, published data on these modalities are briefly reviewed in this paper. Specifically, the Planning Group is interested in the potential for increasing NS access through over-the-counter sales and purchase of injection supplies at pharmacies. In Alaska, there are no 4

6 laws or regulations that require a prescription to be presented when procuring NS at drug stores, making this a viable approach. Despite a lack of legal prohibitions, exploitation of this NS access point is believed to be relatively low. Informal barriers among various participants in the community may be responsible for this low utilization. In order to inform planning decisions, published information on the topic of over-the-counter sales of sterile needles and syringes was reviewed. Barriers to pharmacy sales of NS, as presented in the general literature, were compiled and explored. Published studies related specifically to Alaska were given particular weight during analysis. In circumstances where published works did not provide sufficient information in an Alaskan context, stakeholder groups were contacted via a series of exploratory key informant interviews to gather supplemental information. Interviews gathered data about stakeholder perspectives and, through thematic analysis, helped in the synthesis of barriers and challenges specific to Alaska. Background General approaches to expanding sterile needle access: In an effort in increase IDU access to sterile needles and syringes, a number of different designs of programmatic interventions have been explored in the last 30 years, each with its own advantages and challenges. 5

7 Syringe exchange programs: Barriers to Access: Exploring Factors that Inhibit Use of Over-The-Counter Syringe exchange programs (SEPs) are designed to accept used needles and distribute, in exchange and free of charge, clean injection supplies. Items typically offered for exchange include intravenous needles, syringes, and auxiliary items like cookers, cotton, alcohol swabs, sterile water, filters and tourniquets. These access points serve to increase IDU access to sterile NS as well as to decrease circulation of dirty needles and supplies. Programmatic efforts and exchange practices of SEPs differ from place to place. SEPs may limit services to only NS; clients may receive needles based on a one-to-one exchange, or may simply require some level of needle return to secure clean supplies. Exchange limits may be put in place, or distribution may be unlimited, depending on SEP funding sources and philosophy. Many SEPs distribute educational information, hand out condoms, and provide basic counseling. SEPs also often collect basic empirical data such as demographic or geographic information about clientele (Strike et al, 2011). SEPs are the most common programmatic intervention implemented towards the goal of expanding IDU access to sterile NS (Janulis, 2012). Needle and syringe exchanges have been consistently linked to reductions in risky injection behaviors among injectors, such as needle sharing and needle reuse. SEPs are also credited with having a positive impact in reducing the spread of HIV; conclusions about the impact of these programs on HCV transmission is less clear (Macarthur et al, 2014). 6

8 Pharmaceutical sales: Barriers to Access: Exploring Factors that Inhibit Use of Over-The-Counter Over-the-counter (OTC) equipment purchase via pharmacies, provides [an] alternative for obtaining nonprescription syringe among IDUs in the United States (Janulis, 2012). Noted benefits of pharmacies as a source of NS include: greater proximity to IDUs, more locations, more flexible hours, and reduced stigma in comparison with SEP attendance (Janulis, 2012). The existing infrastructure associated with pharmacies, including established staffing, inventory, and knowledge base, are appealing as a platform to increase NS access from a policy perspective. Similarly, pharmaceutical sales have an additional advantage from the political perspective, because this approach shifts the cost of the equipment to the end user, the IDU, rather than being financed by public funds (CDC, 2005; Coffin, 2000). Increases in over-the-counter pharmacy sales of syringes and needles have been empirically connected to reduction of risky injection behaviors. No studies have definitively confirmed the impact of increased nonprescription sales on HIV and HCV transmission rates (Macarthur et al, 2014). Programmatic Efforts related to pharmaceutical sales in other states: Two programs appear frequently in the body of literature, employ and provide some interesting lessons for those evaluating implementation mechanisms for expanded needle access through pharmacy sales. The programs implemented in New York and California have interesting facets that distinguish them from approaches employed in other states. As a result, reviewing these implementations can highlight potential obstacles to avoid and possible improvements for consideration when constructing a related syringe expansion approach. 7

9 New York State implemented its Expanded Syringe Access Demonstration Program (ESAP) in This program made sales of needles at pharmacies legal without requirement of a prescription. Under ESAP, the New York State Department of Health registers pharmacies, healthcare facilities, and healthcare providers and allows them to sell up to ten syringes per exchange to adults (>18 years of age). Participation in ESAP is voluntary, and needle sales must be accompanied by distribution of information about health issues and proper disposal. Independent evaluation of this program in 2003 reported that the program did not contribute to any increase in substance abuse, public needle discard, accidental needle sticks, or drug-related crime (Rudolph, 2010). This appraisal resulted in extension of the program to 2007; it has since been extended indefinitely as of 2009 (Neaigus, 2008; Rudolph, 2010). This program has been studied extensively, and has been credited with a reduction in syringe sharing. Certain limitations have been encountered by this program; for example, there has been significant exploration of the program s noted inconsistencies in ability to serve minority IDUs (Crawford, 2013). Research indicates that black and Hispanic drug users [in New York City] were less likely to use pharmacies as safe and legal syringe sources as compared with their white counterparts irrespective of geographic location (Fuller, et.al, 2007). Upon recognition of this fact, efforts were installed within ESAP to partner with community-based organizations in affected areas like Harlem and the Bronx. This multilevel, community based approach is novel in the way it integrates social and cultural factors into efforts to support intervention efforts (Fuller, 2007). 8

10 Recent research efforts have also explored the potential for the ESAP program to expand its impact from solely needle access to a more comprehensive intervention strategy. Initial studies show that pharmacists in the ESAP program are supportive of expanding their roles to incorporate intervention and counseling efforts, and indicate that providing education about intervention techniques fosters increased interest in this work (Crawford, 2013). The role of neighborhood pharmacists in health care generally has expanded in recent years, and utilizing their health care expertise to aid patrons battling addition has inherent potential (Rudolph, 2010). California implemented its efforts at increasing nonprescription access to NS through Senate Bill 1159 (SB1159), signed in This law instituted a requirement for approval of programmatic efforts by individual local health jurisdictions (LHJs). Based on the demands of the community served by the LJH, areas of the State could opt in or opt out of participation. Upon confirming participation, each LJH was then tasked with establishing a disease prevention demonstration project (DPDPs) to coordinate efforts between pharmacies and public health officials. Pharmacies register to participate, and then are able to sell 10 syringes without a prescription. LHJs maintain lists of pharmacies and provide educational materials that are distributed with sales. The dual opt-in process has been problematic for this program design, and integration with existing SEP programs has been minimal. About one third of LHJs have opted out of 9

11 participation, reporting community opposition, law enforcement opposition, lack of resources, or lack of interest from pharmacies. Vending machines: Needle and syringe vending machines have been employed with some success, particularly in prison settings and in countries outside the United States. This access point employs mechanical dispensation of single-use or small volume packs of injection supplies- needles, syringes, cotton, alcohol swabs, spoons, sterile water, and informational cards. Machines may accept cash, needle exchange, or keycards distributed by SEPs for this purpose; they may also dispense free of charge (McDonald, 2009; Obadia, 1999). Machines are installed in various locations designated by the individual program. Installations points are often near SEP locations, near pharmacies, or near areas frequented by IDUs. Disposition containers are typically installed alongside devices (McDonald, 2009). Vending machines are indicated to aid in serving people who are apparently reluctant to use [other] outlets. Benefits to this method include 24 hour service, increased anonymity, and convenience (McDonald, 2009). However, studies do not indicate that vending machine access to needles and syringes significantly reduce risky injection practices or disease transmission as effectively as other methods (Macarthur et al, 2014). 10

12 Basic distribution and provision methods: Barriers to Access: Exploring Factors that Inhibit Use of Over-The-Counter Distribution methodologies differ from syringe exchange programs because distribution locations do not link provision and return of NS. Distribution programs allow but do not require an exchange of goods; rather, these sources give sterile NS to those in need of them without the qualifying requirement of turning in old used supplies. Distribution methods may involve singleuse, loaner type circumstances when exchange is not a possibility, or may be more liberal in dispensing larger quantities based on need (Small et.al, 2010). Mobile vans or outreach needle exchange: This approach is a means to expand the impact of SEP-type or distribution-type methodologies. This type of program involves rotating location or on-demand, delivery-style needle provision. A mobile rig is stocked with standard NS and auxiliary supplies and serves areas highlyfrequented by IDUs. Needle distribution via mobile locations sometimes stress one-for-one exchange and trades are typically capped at a low quantity, due to limited on-hand supplies (Small et. al, 2010). Studies specifically related to mobile outreach methods are limited (MacArthur et. al., 2014). Supervised injection facilities: Supervised injection facilities (SIFs) were first initiated in 2007 in Vancouver, Canada. These sites provide a location where IDUs can inject illicit drugs under the supervision of a nurse, access guidance regarding safer injection practices, and obtain clean injecting equipment and referrals to health care and addition counseling (Stoltz et. al 2007). These facilities serve as an 11

13 additional access point for sterile NS, though the volume of supply distribution is not indicated in the literature. They also allow provision of immediate healthcare upon incidence of overdose, and reduce incidence of injection in public venues (Stoltz, et. al., 2007). This methodology is only tentatively linked to reductions in risky injection behaviors (MacArthur et. al, 2014). Facilitation of street sales: Directed efforts to coordinate distribution of verifiably clean (single-packed and sealed) NS through existing street vendors or syringe sellers has been suggested as a potential mechanism to diffuse disease prevention materials and messages directed at IDUs (Stopka et.al, 2003). Proponents suggest that new approaches that integrate the role-holding community members into prevention may be strategic targets for risk-reduction campaigns. These methodologies may be anadvertantly supported by SEPs who distribute needles without a set cap per visit. Programmatic efforts using this methodology and empirical studies were not identified in the course of this project (Stopka, et.al., 2003). Program concepts that address secondary sales of needles are novel, and approaches that address secondary sales have not been extensively explored. Comparison of known methodologies: One study, by MacArthur et. al, reviewed the empirical evidence available gauging the behavioral and disease-reduction impacts of these various interventions. This type of assessment can serve to define best and most impactful practices for increasing sterile needle access. The study listed treatment through opioid replacement, also known as methadone therapy, as the most 12

14 impactful way to reduce disease and change risk behaviors. Of interventions aimed at expanding access to clean needles and syringes, SEPs were listed as the most impactful. Pharmaceutical needle sales, needle provision efforts, educational and counseling programs, and supervised injection locales were all moderately impactful in reducing risk behaviors. Vending machines and mobile vans did not have empirical support confirming significant impacts on behaviors or disease transmission. Information about Alaska s Current Efforts: HIV statistics for the state: From 1982 to 2012, the State of Alaska (SOA) has been informed of 1,482 cases of HIV infection. Of these cases, approximately 36% were known to be deceased at the end of 2012 (State of Alaska Epidemiology Bulletin, 2013). Alaskan persons living with AIDS are predominantly male (80%) and the majority are Caucasian/white (55%). Median age for HIV positive patients is 34 years, with age range extending from birth to 75 years. Over half of the reported HIV patients in the state live in the Municipality of Anchorage or the Matanuska- Susitna valley area (51%). Others live in more rural regions, including the Southeast (5%), Southwest (3%), Northern (1%), Gulf (4%) and Interior (8%) portions of the state. Over one quarter of Alaskan reported HIV cases have moved out of the state since diagnosis (State of Alaska Epidemiology Bulletin, 2013). These statistics do not capture HIV positive residents diagnosed outside the state and living untreated in Alaska, residents that have not reported their positive serostatus, or residents that are unaware of their positive serostatus. 13

15 The population at greatest risk for exposure to HIV in Alaska is men who have sex with men (MSM); 57% of reported cases fall into this exposure category. Intravenous drug users are the second-most impacted risk group, with 21% of reported cases identifying potential exposure through this means (State of Alaska Epidemiology Bulletin, 2013). Estimates of drug activity in Alaska: Inference of the prevalence of intravenous drug use in Alaska is difficult to pinpoint. Figures related to drug use in Alaska infrequently distinguish between the administration methods employed, and therefore cannot easily be tailored to capture the frequency of injection use. The State of Alaska Division of Behavioral Health reports 6,742 admissions for substance abuse treatment in the 15 grantee agencies tracked during There are 77 treatment-based facilities in Alaska, with total patient capacity of 3,218 clients. Additional services may have been administered at other treatment facilities for co-occurring conditions (such as mental health concerns), as well as through private means or out of state. Of those seeking substance abuse treatments in Alaska, 17% report combating drug abuse and 49% report combating combined drug and alcohol dependencies (Alaska Mental Health Board & Advisory Board on Alcoholism and Drug Abuse, 2012). More detailed information on drugs utilized in Alaska is estimated by other sources. Information from the SAMHSA Treatment Episode Data Set states that, in 2011, of patients entering drug treatment, 33% were being treated for marijuana, 15% for heroin, 11% for stimulants, 5% for 14

16 cocaine, and 21% for other opiates. These sources do not provide additional information about the method of consumption used by reporters (Office of National Drug Control Policy, 2013). Funding restrictions for programmatic response: The majority of funding distributed in the state of Alaska by governmental entities is derived from federal CDC HIV prevention funding sources. Available amounts of this funding have been significantly reduced due to recent CDC policy changes. In alignment with the 2010 National HIV/AIDS Strategy issued by the White House, the CDC restructured its distribution of funds to ensure that federal HIV prevention funding allocations go to jurisdictions with the greatest need. As a result, funds distributed to Alaska were cut significantly in 2012, and are expected to be reduced by as much as 50% by 2016 (Alaska HIV Plan, 2013). Similarly, federal funding has use restrictions applied to its distributed funds. Due to prohibitions specified in the annual appropriations process in Congress, notwithstanding any other provision [of this Act], no funds appropriated in this Act shall be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug (Public Law , 2012). As the majority of funding distributed by the State of Alaska has intergovernmental ties, syringe exchange programs must be supported by nongovernmental funding sources, including grants and private contributions. 15

17 Current efforts to reduce HIV transmission: Barriers to Access: Exploring Factors that Inhibit Use of Over-The-Counter Alaska currently has two operating syringe exchange programs, run by the nonprofit organizations Alaska AIDS Assistance Association (Four As) and the Interior AIDS Association (IAA). These organizational efforts are funded through non-governmental means. The State provides many other services in lieu of operating syringe exchange programs. State funds have supported HIV testing efforts for those at high risk of infection, funded condom distribution, developed an Enhanced Linkage to Care program which provides support to the newly diagnosed, coordinates partner services and offers technical assistance and expertise, and has organized programmatic efforts towards planning, monitoring and evaluating current HIV prevention efforts. The State also distributes funds through grant administration to other community stakeholders involved in the efforts to reduce HIV transmission. Supported services include housing efforts, intervention services, training and educational efforts, medication dispensation and drug assistance, medical case management, and testing efforts (Alaska HIV Plan, 2013). Methodology Primary Methodology: Literature Review The primary methodology utilized to compile information on nonprescription sales of NS was a systematic literature review. In order to complete a methodical search of the published literature, a list of search terms was compiled and refined to capture common words and phraseologies 16

18 utilized in papers on this topic. Search terms and phrases are presented in Tables 1a and 1b. These terms were used to guide literature search efforts and to help review found literature for relevance to the given topic. Table 1a: Search Terms Used in Literature Search Search Terms Syringe Needle Access Availability Expanded Increased Buying Sales Selling Purchase Retail Acquisition Legal/Illegal Laws Practices Regulations Restricted Unrestricted Pharmacy (-based) Prescription Nonprescription Injection Injection drug users/idus Drugs Impact Attitudes Influences Concerns Beliefs Barriers HIV AIDS Intervention Prevention Alaska Anchorage Northwest Rural Remote Table 1b: Common Phraseologies Used in Literature Search Common Phraseologies Syringe laws and pharmacy Legal needle access Legal syringe access Pharmacy-based syringe access Pharmacy based needle access Syringe sales practices Expanded syringe availability Legal syringe purchase Legal needle purchase Non-prescription syringe sales Non-prescription needle sales Pharmacy non-prescription syringe distribution Literature searches were completed using the Consortium Library, PubMed, and Google Scholar search engines. Additional sources were compiled by reviewing the works of trending authors and by reviewing citation lists included with meta-analyses compiled in this process. Studies were considered for inclusion if the abstract or body of the article was related to nonpharmaceutical sales of needles and syringes or programmatic efforts suggested to supplement this mechanism of access. Studies that were principally duplicative of previously reviewed 17

19 articles were not included. Studies were also generally excluded if they were published prior to 2000; exceptions were made if the source was considered especially pertinent, or addressed a novel topic not examined elsewhere in the literature. Sixty-one documents were included in this analysis. Secondary methodology: Key informant interviews A secondary methodology was used to gather exploratory data about this topic when the published literature did not provide ample information specific to Alaska. No published studies could be identified related specifically to Alaskan law enforcement, elected official or government/community organization stakeholder groups. Key informant interviews were conducted with members of these stakeholder groups to capture relevant perspectives and insight from these communities. Organizational candidacy for recruitment were determined based on status in the community, previous interaction with the Alaska HIV Planning Group (HPG), and estimated accessibility of organizational representatives. Individual interviewees within these organizations were isolated based on employee title, recommendations from initial contacts at these entities, or previous interaction with the client. Candidates identified for interview included members of the state and municipal law enforcement community, the HIV/HCV support community, the substance addiction support community, syringe exchange directorial staff, and state and local legislative bodies. A list of contacted organizations is included as Appendix A. 18

20 Interviews were conducted with 10 of 25 contacted entities between March 17 th and March 31 st, Additional classification of participating entities is presented in Table 2. Identified stakeholders were contacted via phone and to set up arrangements for interviews. Of the 10 interviews completed, two were completed in person, 7 over the phone, and one was submitted in writing via exchange. Interviews were conducted in a semi-structured format, with a brief introduction of the subject matter followed by open-ended inquiries. Questions were aimed to capture stakeholder knowledge, positions, level of support, and concerns relating to possible programmatic implementations. Questions were designed to be broad and allow interviewees to share personal viewpoints and lead the direction of the inquiries. Questions were pretested and edited prior to use for formal interviews. The script for interviews is included as Appendix B. Field notes were taken during these interviews and summarizations were authored immediately after the interview exchange. Interview notes were reviewed as primary source data and analyzed for common themes. Table 2: Response Rates for Key Informant Interviews Response Rates for Key Informant Interviews SEP organizations: Contacted 2, received input from 2 HIV/HCV support organizations: Contacted 4, received input from 2 Substance abuse support organizations Contacted 4, received input from 1 Law enforcement representatives Contacted 4, received input from 1 Elected officials: Assembly Contacted 9, received input from 4 Elected officials: State Legislature Contacted 6, received input from 0 19

21 Results Barriers recognized in the general literature: Structural barriers: Legal barriers are the primary structural interference that restricts pharmaceutical sales of nonprescription NS. In 52 U.S. regions reviewed in 2012, nonprescription sales of NS are overtly legal in 22, questionably legal in 22, and prohibited in 8 (this includes the 50 states, the District of Columbia, and Puerto Rico). Laws that restrict this route of access include both state and local drug paraphernalia laws as well as state prescription regulations. Many states have clarified or loosened legal restrictions related to syringe possession as a part of programmatic efforts aimed at increasing utilization of pharmacies as a source of injection supplies (Janulis, et.al, 2012). Some governmental entities have also issued policy statements and public health guidelines to encourage relaxation of these legal barriers (Taussig, 2000). Barriers for intravenous drug users: Elements identified in the literature as contributing factors to IDU underutilization of pharmacies as a source of sterile needles and syringes include: 20

22 Table 3a: General barriers For IDUs Barriers to Access: Exploring Factors that Inhibit Use of Over-The-Counter Barrier Lack of information or concerns about the legality of NS purchase at pharmacies Discomfort regarding expectations at the point of purchase: self-identification via ID or sales log, questions about justifying need, etc. Poor treatment, discomfort or rebuff during previous purchase attempts Sources Recognizing Barrier Janulis, 2012 Finlinson, 2000 Janulis, 2012 Finlinson, 2000 Zaller, 2012 Lutnick, 2012 Cost of supplies Fisher et al, 2000 Concern about being overcharged Pollini, 2010 Quantity required for purchase Janulis, 2012 Finlinson, 2000 Distance from a pharmacy Finlinson, 2000 Concerns about legal status of carrying injection supplies Concerns about law enforcement harassment or arrest Janulis, 2012 Coffin, 2000 Finlinson, 2000 Finlinson, 200 Bluenthal, 2004 Silverman, 2012 The literature also suggests that certain populations of IDUs are routinely underserved by this route of access to sterile needles and syringes. Populations that have been empirically demonstrated in some locations to have less access, to be less likely to attempt, or to be less likely to succeed in obtaining NS via pharmacy sales include: 21

23 Table 3b: Attributes of IDUs Associated with Reduced Utilization of Pharmacies User Attribute Associated with Reduced Utilization of Pharmacies as a Needle Source Males Older IDUs Minorities, including African Americans and Latinos IDUs living in high-need minority-predominant neighborhoods IDUs living in urban area- as opposed to suburban or rural Sources Recognizing Barrier Janulis, 2012 Battles, 2009 Fuller, 2007 Stopka, 2012 Janulis, 2012; Gleghorn, 1998 Battles, 2009; Stopka, 2012 Janulis, 2012 Stopka, 2012 Cooper, 2000 Compton, 2004 Deibert, 2006 Homeless populations Pollini, 2010 Non-methamphetamine injectors Stopka 2012 IDUs with higher expressed comfort with reuse of NS Pollini 2010 IDUs with higher expressed comfort with sharing NS Pollini 2010 Low frequency injectors OR high frequency injectors, depending on opportunities for sourcing injection supplies Janulis, 2012 Barriers for pharmacists: Elements commonly identified in the literature as informal barriers curbing pharmacists from selling over-the-counter syringes and needles to patrons without prescriptions include: 22

24 Table 4: Barriers for pharmacists Barriers to Access: Exploring Factors that Inhibit Use of Over-The-Counter Barrier Concern about or lack of clarity regarding the legality of nonprescription sales of NS Restrictive or unclear store policies or pharmacy regulations regarding sales of NS Lack of information or insufficient training about benefit of pharmaceutical sales of NS without a prescription Personal doubt or misinformation about the health impact of this avenue for access to sterile NS Stigmatizing attitudes about IDUs by individual pharmacists or those setting store policy Concerns about potential impact on pharmacy business Sources Recognizing Barrier Janulis, 2012; Coffin, 2000; Taussig, 2000; Finlinson, 2000; Pollini, 2010; Taussig, 2002; Deibert, 2006 Janulis, 2012; Coffin, 2000; Taussig, 2000; Taussig, 2002 Janulis, 2012; Fuller, 2007 Taussig, 2002; Fuller, 2007 Janulis, 2012; Coffin, 2000; Pollini, 2010; Taussig, 2002 Janulis, 2012; Zaller, 2010; Taussig, 2002; Deibert, 2006 Concerns about deception on the part of the purchaser Taussig, 2002 Concern over perceptions of other patrons Zaller, 2010; Gleghorn, 1998 Negative experiences in past sales to IDUs Taussig, 2000 Lack of familiarity with the purchaser Finlinson, 2000; Gleghorn, 1998 Concern over purchasers appearance of sobriety Gleghorn, 1998 Reluctance to sell individually packed needles Coffin 2000 Reluctance to offer associated disposal programs Coffin, 2000 Fear of increased theft or crime in and around store locations Janulis, 2012; Taussig, 2000; Pollini, 2010; Gleghorn, 1998; Deibert,

25 Concern for the safety of staff members Janulis, 2012; Taussig, 2000; Pollini, 2010; Deibert, 2006 Concern that drug use will occur on the premises Janulis, 2012; Pollini, 2010 Concern that needle discard will become more prevalent on the premises Janulis, 2012; Taussig, 2000; Pollini, 2010; Fuller, 2007 Concern over encouraging illegal drug use Janulis, 2012; Fuller, 2007 Concern over potential resale of the equipment Coffin, 2000 Correlative studies indicate that chain pharmacies are more likely to sell NS without demand for prescriptions (Compton, 2004). Recent studies indicate that, over time, pharmacists are becoming more supportive of liberalized policies related to NS sales (Janulis, 2012). In general, the perspectives and policy applied by pharmacists directly align with company policy; however, over time, personal perceptions appear to change with greater expedience than official policies (Deibert, 2006). Research also indicates that pharmacies who have been enlisted in a public health advocate role as a part of expanded syringe access programs exhibit increased support for and participation in those efforts (Crawford, 2013). Training programs utilized to educate and inform pharmacists have a positive impact; as stated by Randolph, pharmacist and technicians felt that they had learned a great deal about HIV prevention and drug use from [our] community partners and felt better equipped and inspired to interact with their IDU customers and serve their community through HIV prevention (2010). 24

26 Barriers for the law enforcement community: Barriers to Access: Exploring Factors that Inhibit Use of Over-The-Counter The body of literature addressing the barriers to support of pharmaceutical nonprescription sales of NS faced by the law enforcement community is sparse in comparison to other stakeholder groups. The majority of published information outlining the barriers to support for law enforcement communities relates to support of needle exchange programs specifically. While these barriers may not exactly parallel law enforcement opinions about pharmaceutical sales to IDUs, these barriers may give some insight into areas of concern. Elements commonly identified in the literature as barriers to support include: Table 5: Barriers for law enforcement Barrier Lack of information about legal changes permitting needle access programs Lack of training regarding benefits of syringe access programs Skepticism or personal disapproval towards program Limited time/resources to coordinate with or train about program Sources Recognizing Barrier Silverman, 2012 Beletsky, 2012 Beletsky, 2010 Silverman, 2012 Beletsky, 2012 Silverman, 2012 Beletsky, 2012 Silverman, 2012 Little management push to support program Beletsky, 2010 Concern over promoting illegal drug use Conflicting priorities between promoting public health and enforcing the law Beletsky, 2012 Beletsky, 2010 Silverman, 2012 Heller and Paone,

27 Concern about implications for standard operating procedures, such as probable cause searches or safety pat downs Concern over impact on occupational health, such as needle sticks; a related concern is impact on stress levels, due to perceived risk Beletsky, 2012 Silverman, 2012 Beletsky, 2012 Beletsky, 2010 Barriers for the elected official community: Published information outlining the barriers to support for elected officials captures barriers associated with both pharmaceutical sales of nonprescription NS and needle exchange programs. Elements commonly identified in the literature as barriers to support for these efforts include: Table 6: Barriers for elected officials Barrier Sources Recognizing Barrier Concern over needle discard in public settings Backes and Rose, 2010 Concern about implications for public safety tools such as probable cause searches Backes and Rose, 2010 Assertion that IDUs would not/could not change behaviors Backes and Rose, 2010 Personal doubt or misinformation about the health impact of this avenue for access to sterile NS Observed or perceived opposition from constituents or negative public opinion Observed or perceived opposition from community leaders, law enforcement communities or public health advocates Conflicting priorities between promoting public health and enforcing the law Desire to align with other governmental entities, such as with Backes and Rose, 2010 Heller and Paone, 2011 Heller and Paone, 2011 Heller and Paone, 2011 Center for Disease Control, 2005 Heller and Paone,

28 the federal ban on funding Lack of leadership Tempalski, 2007 Negative press about the topic Heller and Paone, 2011 Poor general political climate Heller and Paone, 2011 Barriers for government and community organizations: Governmental and community organizations are charged with implementing and supporting programmatic efforts aimed at increasing sterile needle and syringe access points. Published information outlining the barriers to support for governmental and community organizations capture barriers that are associated with both pharmaceutical sales of nonprescription NS and needle exchange programs. Elements commonly identified in the literature as barriers to support for these efforts include: Table 7: Barriers for government and community organizations Barrier Sources Recognizing Barrier Oppositional political environment Heller and Paone, 2011 Strong community opposition Stopka, 2006 Law enforcement opposition Competing priorities or limited time/resources to contribute to program efforts Garfein, 2010 Stopka, 2006 Garfein, 2010 Stopka, 2006 Little departmental or organizational interest in the program Garfein, 2010 Pharmacy disinterest or difficulty enlisting participation Garfein, 2010 Stopka,

29 Trouble educating stakeholders Garfein, 2010 Difficulty securing approval Garfein, 2010 Discord or misalignment between different levels of organization Tempalski, 2007 Previous observed non-compliance with programmatic requirements Kral, 2010 Barriers for the General Public: Published information outlining the barriers to support for the general public captures barriers associated with both pharmaceutical sales of nonprescription NS and needle exchange programs. Elements commonly identified in the literature as barriers to support for these efforts include: Unaware of nonprescription sales at pharmacies (Fuller, 2007); Concern over street litter of NS (Fuller, 2007); Concern over increases in illegal drug use (Fuller, 2007); Perception of and stigma towards drug use (Tempalski, 2007); Concern over impact on community as a whole (Heller and Paone, 2011); Entrenched social stratification (Tempalski, 2007). Due to time constraints and concerns regarding the need for Institutional Review Board approval, the general community was not consulted as a part of the key informant interviews completed for this project. Recognized Barriers in the State of Alaska Structural barriers: Certain federal laws and restrictions may affect the ability of Alaskan IDUs to utilize mail-order pharmacies for the purpose of obtaining sterile NS. Legality of interstate sales of needles and 28

30 syringes for individual use without a prescription is unclear. Federal laws prohibit use of the services of the Postal Service or other interstate conveyance as part of a scheme to sell drug paraphernalia, and define paraphernalia in broad terms: any equipment, product, or material of any kind which is primarily intended or designed for use in preparing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance (42 U.S.C. 857, 42 U.S.C. 863). At the state level, there are no laws prohibiting or limiting the sales or distribution of needles and syringes in the absence of a prescription (State of Alaska, 2012). At a local level, certain jurisdictions within the state impose additional legal barriers to sales. Specifically, the municipal code in the state s largest metropolitan area, Anchorage, contains prohibitions on [intentional or knowing possession of] drug paraphernalia in public regardless of whether the item of paraphernalia is publicly displayed (AMC , AMC ). This code describes drug paraphernalia in terms similar to those relayed in federal code; the semantics of this law provide latitude regarding legality of sales of sterile NS but impose a penalty on possession for perceived illegal uses (Harbke, 2000). Barriers for intravenous drug users: Three studies were identified as resources for determining IDU barriers to utilization of over-thecounter needle and syringe purchase within the state of Alaska. Study participants in these reports were drawn from Anchorage, Fairbanks, and an outreach correctional facility on the Kenai Peninsula. As a result, they may have some limitations for generalization to the greater 29

31 Alaskan IDU population, and may under-represent perspectives of IDUs in more rural Alaskan locations. These studies indicate that Alaskan IDUs often choose to employ various needle sources, in addition to accessing via pharmacies. Named alternative sources include local syringe exchange programs, hospitals, veterinary clinics, relatives, diabetic associates, and other friends; additional sources are indicated but not named (State of Alaska, 2012; Fisher, 2003; Schlicting, 2002). Studies report that around 30% of Alaskan IDUs self-report accessing needles through over the counter sales at pharmacies (State of Alaska, 2012; Fisher, 2003). Degrees of success in purchase reported vary significantly by report. Identified barriers to pharmacy utilization for Alaskan IDUs include: Lack of knowledge regarding legality of purchase (Fisher, 2003); Lack of planning around drug consumption or needle access (Fisher, 2003); Attempted efforts to reduce drug use (Fisher, 2003); Lack of skills to purchase NS in a pharmacy setting (Fisher, 2003); Embarrassment (Fisher, 2003; Schlicting, 2002); Negative experience or heavy questioning at the point of purchase (Schlicting, 2002); Running into family or friends (Schlicting, 2002); Restricted pharmacy hours (Schlicting, 2002); Transportation (Schlicting, 2002). 30

32 Demographic information about Alaskan IDUs in these studies indicate that the following populations are less likely to attempt or less likely to succeed in obtaining NS via pharmacy sales: Male IDUs (Fisher, 2003); Low-frequency injectors (Fisher, 2003); Lower income IDUs (Fisher, 2003); Cocaine injectors (Fisher, 2003). Very few intravenous drug users surveyed in these studies indicated that cost of NS at pharmacies was prohibitive or served as a barrier to access (Fisher, 2003). Survey participants indicate that, particularly in comparison to the drugs themselves, injection equipment is relatively inexpensive (Schlicting, 2002). Barriers for pharmacists: Three studies were identified as resources for determining pharmacist barriers to completing sales of over-the-counter needle and syringes with IDUs in the state of Alaska. Study respondents in these reports include both urban and rurally-based pharmacies; participating pharmacies were drawn from comprehensive lists of pharmacies in the state in two of the three reports (State Of Alaska, 2012; Harbke, 2000). Studies approximate that 13% of Alaska pharmacies permit all sales of needles and syringes, regardless of prescription. Another 13% of pharmacies report policies requiring prescriptions for all sales. The vast majority of Alaskan pharmacies, 74%, report that the decision regarding completion of NS sales is left to the discretion of the pharmacist on duty (Harbke, 2000). 31

33 Primary considerations, as identified by pharmacists, swaying this discretion and impacting the sales of nonprescription NS are concern over purchaser s appearance of sobriety, level of familiarity with the purchaser, and general concern for the patron s health. Alaskan pharmacists report that patron appearance, concern regarding theft, and the presence of other customers do not impact decisions on whether or not to sell (State Of Alaska, 2012; Harbke, 2000). Stakeholder perspectives and barriers for the law enforcement community: No published literature addressed barriers to the law enforcement community in Alaska specifically. For this reason, this population was explored using the key informant interview methodology. During the interview process, stakeholder perspectives were collected and thematic analysis allowed for correlation of recognized law enforcement barriers. Only a single representative of the law enforcement (LE) community was successfully enlisted for participation in the interview process. This informant represented the viewpoint of the municipal level of law enforcement only. However, analysis of this interview does provide anecdotal evidence to support several of the barriers identified in the literature. The interview also suggests that other noted barriers may not impact Alaska specifically. Limited access to information or training about NS access programs was not emphasized as a significant barrier in the informant interview, though the participant did state that they had not given this [subject] much thought. 32

34 Significant emphasis was placed by the interviewee on the health of the drug user. The stakeholder interviewed stated that calls regarding drug use in vehicles, including outside locations like pharmacies, are already common. Overdose scenarios were emphasized as a medical response situation, rather than an opportunity for policing. In this discussion, the interviewee acknowledged that drug use in cars outside pharmacies might be a concern for pharmacists, but that calls of potential drug use would be low priority calls from the standpoint of law enforcement. Significant emphasis was placed during the interview on concerns regarding impact on officer occupational safety and health, especially regarding needle sticks. The informant stated that needle sticks were a significant concern. The informant also stated that they were unsure about a connection between access to free needles and increased presence of needles on the streets; increase was indicated as logical but countered with the argument that people who want to shoot heroin already know where to get [needles]. Concern about implications for probable cause searches were not indicated as a significant concern for the Alaskan LE community based on this stakeholder interview. The key informant indicated that the presence of needles alone would not likely result in police search, as needles have another medical purpose. Elements that provide context regarding the potential illicit use of the needles, such as brown cotton, appearance of intoxication, or known drug history might play a more significant role in potential for search than would the presence of needles. 33

35 Overall, the key informant stated that their professional level of support for over-the-counter sales of needles and syringes to pharmacy patrons without a prescription was neutral. The informant would also be neutral to any programmatic efforts made regarding such a program, stating that the existence of the SEP in Anchorage made it less important because there are already free needles available. In all, thematic analysis of this interview suggests that concern over needle discard and concern for the health of drug users serve as barriers for elected official stakeholders in Alaska. This interview suggests that concern over impacts on probable cause searches may not be a barrier to support for Alaskan law enforcement. Stakeholder perspectives and barriers for the elected official community: No published literature addressed barriers to elected officials in Alaska specifically. For this reason, this population was explored using the key informant interview methodology. During the interview process, stakeholder perspectives were collected and thematic analysis allowed for correlation of recognized elected official barriers. Four representatives of the elected official community were successfully reached and provided input for this review. These informants represented the viewpoint of the municipal level of government only. 34