Abstract
Objectives.
In an effort to reduce HIV transmission among injection drug users (IDUs), New York State deregulated pharmacy syringe sales in 2001 through the Expanded Syringe Access Program by removing the requirement of a prescription. With evidence suggesting pharmacists’ ability to expand their public health role, a structural, pharmacy-based intervention was implemented to determine whether expanding pharmacy practice to include provision of HIV risk reduction and social/medical services information during the syringe sale would (a) improve pharmacy staff attitudes toward IDUs (b) increase IDU syringe customers, and (c) increase prescription customer base in New York City neighborhoods with high burden of HIV and illegal drug activity.
Methods.
Pharmacies (n = 88) were randomized into intervention (recruited IDU syringe customers into the study and delivered intervention activities), primary control (recruited IDU syringe customers only) and secondary control (did not recruit IDUs or deliver intervention activities) arms.
Results.
Pharmacy staff in the intervention versus secondary control pharmacies showed significant decreases in the belief that selling syringes to IDUs causes community loitering.
Conclusions.
Structural interventions may be optimal approaches for changing normative attitudes about highly stigmatized populations.
Keywords: community-based participatory research, health behavior, health disparities, HIV/AIDS, substance use
Prevention efforts to reduce HIV among high-risk populations have been successful (Crawford & Vlahov, 2010), particularly those aimed at increasing access to sterile needles/syringes for those who are unable to stop injection drug use (Vlahov, Fuller, Ompad, Galea, & Des Jarlais, 2004). However, public health messages that advocate behavior change, without complimentary attention to the social and environmental factors that may counter behavior change, have had marginal success in reducing HIV in the United States (Friedman et al., 1992). Interventions that target relevant social and environmental factors are typically what researchers refer to as structural or multilevel interventions, where either features of the structural or social environment is the target of the intervention, or both behavioral and structural factors serve as the target (Blankenship, Bray, & Merson, 2000; Blankenship, Friedman, Dworkin, & Mantell, 2006). A growing body of evidence suggests that the most optimal HIV prevention strategies are structural/multilevel intervention designs (Manhart & Holmes, 2005).
One example of a successful structural intervention is the Expanded Syringe Access Program (ESAP) established by New York State in 2001, which allowed syringe sales in pharmacies without a prescription to increase sterile syringe access for injection drug users (IDUs) thereby reducing HIV transmission among IDUs. Evidence from ESAP evaluation studies have indicated success in improving pharmacy access to sterile syringes for IDUs (Deren et al., 2006) as well as other unintended positive effects including syringe disposal (Cleland et al., 2007; Jones & Coffin, 2002) and reduced syringe sharing (Pouget et al., 2005) among IDUs.
While early studies have noted significantly lower use of pharmacies as a syringe source among Black and Latino/a IDUs compared with their White counterparts (Deren et al., 2006; Des Jarlais, McKnight, & Friedmann, 2002; Fuller et al., 2004), it is possible that this may have been partly because of pharmacy staff’s unfamiliarity with IDU customers, resulting in unwillingness to sell syringes and beliefs that community members would not want to patronize a business that they believed encouraged drug use (Battles, Rowe, Ortega-Peluso, Klein, & Tesoriero, 2009; Linas, Coffin, Backes, & Vlahov, 2000). Several evaluations of New York State’s ESAP showed that participating pharmacists became more supportive over time (Vlahov et al., 2003). Moreover, targeting community and pharmacy staff knowledge and awareness of drug dependence and nonprescription syringe sales in pharmacies improves support of ESAP and attitudes about the program’s community impact on drug use and HIV transmission (Fuller et al., 2007).
Herein, we set forth to provide stronger evidence of the impact of ESAP on pharmacy staff and pharmacy practices related to expanded syringe access. To date, this is the first large-scale pharmacy-randomized intervention design that we are aware of to evaluate pharmacy syringe access that is community-based and targeted to Black and Latino IDUs. Previously published data from this study have shown that pharmacy staff who were engaged in offering additional medical and social service referrals to IDUs during the syringe sale were significantly more supportive of ESAP over time compared with pharmacy staff who were not engaged in offering these services (Crawford et al., 2013). In this article, we are taking a closer look at the impact of this intervention (i.e., offering medical/social service referrals during syringe sale to IDUs) on pharmacy staff opinions and attitudes, beyond general support for ESAP. Specifically, we examined pharmacy staff perceptions of ESAPs’ impact on community factors, including improper syringe disposal, loitering, increased illegal drug use and HIV transmission. We hypothesize that pharmacy staff who participate in the intervention will have more positive attitudes about ESAPs’ impact on community factors compared with those who were in the control group over time.
Method
This analysis uses data from the Pharmacists as Resources Making Links to Community Services (PHARM-Link) study. The overall objectives of PHARM-Link were to test whether the delivery of HIV prevention information and other medical and social service referrals to IDUs by pharmacy staff (1a) influenced pharmacy staff perceptions of ESAP and IDUs and (b) influenced IDUs’ risk behaviors. Details of the pharmacy population and recruitment procedures have been previously described elsewhere (Rivera et al., 2010) and results of the intervention on IDU outcomes are forthcoming. Below we provide more detailed account of the study methods that have not been previously published. This study was approved by the institutional review boards at the New York Academy of Medicine and Columbia University Medical Center.
Study Population, Recruitment, and Eligibility
Geographic target areas of high drug activity were ethnographically mapped in Upper and Lower Manhattan, Bronx, Brooklyn, and Queens. All pharmacies within these areas were cross-checked against a list of all ESAP-registered pharmacies provided by the New York State Department of Health and visited by research staff to confirm that they were still participating in ESAP at study start-up. If pharmacies were no longer in business or no longer ESAP-registered they were removed from the list. Once a complete list of pharmacies was compiled, we performed screener phone surveys to determine study eligibility. Eligible pharmacies reported (a) at least one new nonprescription syringe customer each month, (b) at least one new syringe customer who becomes a regular customer each month, (c) willingness to sell syringes to IDUs without additional requirements other than those specified in the law (i.e., require proof of age ≥18 years). Of 325 pharmacies that were screened for study participation, 172 were eligible, 42 did not participate (11 declined participation following screener, 31 became ineligible following screener); and staff within the remaining 130 pharmacies completed a baseline survey. Of those, all pharmacy staff (i.e., pharmacists, pharmacy technicians, and clerks) in 88 pharmacies (67%) agreed to be randomized into one of three arms by New York City borough: intervention (n = 26; recruited IDU syringe customers into the study and delivered intervention activities), primary control (n = 29; recruited IDU syringe customers only) and secondary control (n = 33; did not enroll IDU syringe customers) group. The 42 pharmacies that declined randomization were uncertain of their ability to satisfactorily adhere to the research protocol. Consent from all pharmacy staff in each pharmacy was needed for pharmacy participation and informed consent was obtained from each member of the pharmacy staff. Although most pharmacies remained in the study over follow-up, there were slightly fewer pharmacies in the primary control arm; however, pharmacy and pharmacy staff characteristics did not differ by attrition. In the intervention group there were 18 pharmacies (69.2% follow-up rate) at the 6-month follow-up and 20 pharmacies (76.9% follow-up rate) at the 12-month follow-up. In the primary control group there were 21 pharmacies (72.4% follow-up rate) at the 6-month follow-up and 19 pharmacies (65.5% follow-up rate) at the 12-month follow-up. And in the secondary control group there were 27 pharmacies (81.8% follow-up rate) at the 6- and 12-month follow-up. We compared pharmacy staff characteristics (race, gender, position, pharmacy area) across the follow-up visits and found no statistical differences in attrition (p > .05).
Pharmacy Intervention
The pharmacy staff intervention included a harm reduction training series which included effective strategies on how to (a) engage IDU customers in conversations while creating a comfortable and nonjudgmental environment, (b) provide referrals for service organizations useful for IDUs, and (c) inform IDU customers about our study and schedule enrollment appointments. In addition, pharmacy staff were provided information on use of pharmacy staff as public health providers, the scope of HIV and drug abuse in the community, pharmacy syringe access and the need for extended services from pharmacies, understanding injection drug use and chemical dependency, and relevant research articles and information on drug treatment modalities. The training series included a group pharmacy staff training seminar and a series of individual trainings.
Group Training
The group pharmacy training was an off-site seminar developed in partnership with the Pharmacists Society of the State of New York and pharmacists received continuing education credits for participating in the trainings. The training was led by members of our Pharmacy Working Group composed of researchers, pharmacists, community members, New York State Department of Health professionals, and physicians with experience working with IDUs and/or HIV positive populations. A pharmacy training manual grounded within a harm reduction framework was developed by the Pharmacy Working Group and provided to all pharmacy staff in the intervention arm. In addition, a 10-minute video developed by the research team and the Pharmacy Working Group which depicted appropriate interactions with IDU syringe customers including providing social service referrals and study enrollment activities was shown and discussed with intervention pharmacy staff. All pharmacy staff from each pharmacy attended one group training which took place on an evening agreed upon by the participating pharmacists. A total of four evening training sessions were conducted with staff from approximately six pharmacies in attendance.
Individual Training
In order to supplement the group pharmacy training, individual one-on-one trainings between each pharmacy staff member and a research staff member were conducted to (a) reiterate the overall goals of the group pharmacy training, (b) role-play an engaging interaction with an IDU customer, and (c) practice intervention activities. One-on-one trainings were conducted quarterly, when new staff were hired, or when protocol violations were observed. For example, quality control syringe “test buys” were conducted quarterly by a research staff member unknown to the pharmacy staff to ensure that pharmacy staff were adhering to the ESAP guidelines (New York State Department of Health, 2010) and the research protocol. When a test-buy revealed that study procedures were not being adhered to (i.e., failure to provide required ESAP insert or IDU referral into the study), all members of the staff were retrained. If a second violation occurred, the supervising pharmacist was notified that the pharmacy was no longer eligible to participate in the study. Only two pharmacies (one from the intervention and one from the primary control) were removed.
To facilitate pharmacy staff social and medical service referrals, we provided safe injection packets to intervention pharmacies to distribute to their IDU syringe customers which included booklets on local service providers, drug treatment options, safe injection tips, disposal options, HIV and hepatitis C testing and treatment information, as well as condoms, personal sharps disposal containers, alcohol prep pads, and hand sanitizer to promote safe use and disposal of syringes.
Pharmacies that were randomized to the primary control group did not participate in the complete harm reduction training series nor extend additional services to IDUs. However, they were trained on how to engage their IDU syringe customers, offer enrollment into our study, and schedule an appointment if they were interested. Given the potential for the primary control group to develop more positive attitudes as a result of their training thereby dampening the potential for an intervention effect, if one exists, we included a secondary control group of pharmacy staff. Those randomized to this condition received no research training activities or additional contact from research staff with the exception of the follow-up surveys.
Data Collection
Following the baseline survey, pharmacy staff in the intervention and control pharmacies completed 6- and 12-month follow-up surveys using computer-assisted personal interviews, all taking approximately 40 minutes to complete. The baseline survey instrument, which assessed pharmacy staff beliefs about nonprescription syringe sales, syringe (ESAP) customer sales, beliefs about other public health services being offered in the pharmacy, and the role of syringe sales on HIV transmission can be found online (Rivera et al., 2010). The 6- and 12-month surveys also ascertained pharmacy staff beliefs about syringe sales, ESAP customers, and public health services to determine the effect of the pharmacy intervention on the following outcomes: negative beliefs about IDU syringe sales (yes/no), and number of prescription and nonprescription customers (continuous).
Variable Definitions and Analysis
In this analysis, we assessed whether or not the intervention influenced pharmacy staff beliefs that selling syringes to IDUs (a) influenced loss of business, (b) resulted in crime or theft by syringe customers, (c) caused improper disposal of syringes near stores, (d) caused the community to be littered with dirty syringes, (e) caused IDUs to increase drug use, (f) encouraged drug use, and (g) reduced transmission of HIV among IDUs. All responses to the measures about pharmacy staff beliefs on selling syringes to IDUs were yes/no. We also assessed whether the intervention influenced pharmacy staff reports of the number of syringe sales in the past week (continuous) and the average number of syringe customers who patronized the pharmacy in the past month.
We present comparisons of trends over time by study arm and differences at 12-month follow-up between study arms using Cochran–Armitage test for trend, and chi-square test and/or Fisher’s exact test, respectively. When significant differences in pharmacy staff attitudes, syringe sales, and customer base were present postintervention (12-month visit), we estimated the effect of the intervention at the 12-month visit accounting for the hierarchical structure of pharmacy staff clustered within pharmacies and baseline differences using a multilevel model. We present a stepwise model that compares the support levels between the intervention and the primary control group, and between the intervention and the secondary control group accounting for clustering of pharmacy staff within pharmacies (Model 1), accounting for baseline differences (Model 2) and controlling for significant (p < .05) pharmacy characteristics (Model 3). Log-binomial regression was used to estimate the prevalence ratio and a robust error variance was specified to account for the small number of pharmacy staff within pharmacies and directly estimate the standard error. All data management and analyses were performed using SAS version 9.2 (SAS Institute Inc., 2008).
Results
Characteristics of the pharmacy and pharmacy staff by study arm are shown in Table 1. At the pharmacy level, there were no differences between the intervention and control groups by pharmacy type (independent/chain) or pharmacy borough. When examining pharmacy staff characteristics, there were no differences in pharmacy staff position (pharmacist/technician), gender, or perceived neighborhood drug level (low/medium/high) by randomization arm. However, differences were observed by race/ethnicity with significantly more Black pharmacy staff represented in the primary and secondary control arms.
Table 1.
Differences in Pharmacy-Level (n = 88) and Pharmacy Staff (n = 383) Characteristics by Study Arm, PHARM-Link 2009–2011.
| Study Arm, n (%) |
||||
|---|---|---|---|---|
| Characteristics | Intervention | Primary Control | Secondary Control | p Value |
|
| ||||
| Pharmacy characteristics | ||||
| Pharmacy type | ||||
| Independent | 18 (69.23) | 18 (62.07) | 17 (51.52) | .3741 |
| Chain | 8 (30.77) | 11 (37.93) | 16 (48.48) | |
| Borough | ||||
| Bronx | 6 (23.08) | 7 (24.14) | 9 (27.27) | .9632a |
| Brooklyn | 5 (19.23) | 7 (24.14) | 6 (18.18) | |
| Queens | 3 (11.54) | 4 (13.79) | 3 (9.09) | |
| Upper Manhattan | 3 (11.54) | 5 (17.24) | 7 (21.21) | |
| Lower Manhattan | 9 (34.62) | 6 (20.69) | 8 (24.24) | |
| Individual characteristics | ||||
| Position | ||||
| Pharmacist | 53 (40.15) | 53 (40.46) | 46 (38.33) | .9341 |
| Technician | 79 (59.85) | 78 (59.54) | 74 (61.67) | |
| Gender | ||||
| Female | 71 (53.79) | 87 (66.41) | 72 (60.00) | .1126 |
| Male | 61 (46.21) | 44 (33.59) | 48 (40.00) | |
| Race | ||||
| Black | 10 (7.63) | 34 (25.95) | 22 (18.49) | .0002 |
| White | 22 (16.79) | 18 (13.74) | 9 (7.56) | |
| Hispanic | 57 (43.51) | 44 (33.59) | 36 (30.25) | |
| Other | 42 (32.06) | 35 (26.72) | 52 (43.70) | |
| Perceived neighborhood drug level | ||||
| High | 64 (57.14) | 79 (68.70) | 56 (54.37) | .1988 |
| Moderate | 35 (31.25) | 26 (22.61) | 37 (35.92) | |
| Low | 13 (11.61) | 10 (8.70) | 10 (9.71) | |
Note. PHARM-Link = Pharmacists as Resources Making Links to Community Services.
Fisher’s exact test used.
Negative pharmacy staff attitudes and beliefs about selling syringes to drug users remained low throughout the intervention (Table 2). Moreover, pharmacy staff’s belief that selling syringes to IDUs results in crime reduced significantly across all study groups. Beliefs that selling syringes to IDUs resulted in loitering and encouraged drug use significantly declined among the intervention group only. There were increasing trends in the belief that selling syringes to IDUs reduces HIV transmission across all study groups that demonstrated borderline statistical significance for the intervention and statistical significance in the primary control groups. And finally, those in the intervention group had significant increases in the belief that selling syringes results in loss of business. However, at the 12-month visit there were no significant differences in business loss, crime, or improper syringe disposal reported by study group. Moreover, pharmacy staff’s belief that selling syringes to drug users encourages drug use and the belief that selling syringes to drug users reduces HIV transmission were not statistically different across study arms. Although pharmacy staff across all study arms perceived lower community loitering because of selling syringes to drug users postintervention, these differences were significantly lower in the intervention pharmacy (15.49%) compared with the secondary control (29.33%; p = .0491). When accounting for baseline differences and race, the association between perception of community loitering and intervention versus secondary control condition was slightly dampened (Table 3). Finally, although there was a general decline in the number of syringes sold when comparing pre- and postintervention periods, these differences did not differ across the study arms postintervention and, significant declines in ESAP syringes sold were only observed in the primary and secondary control groups. Although it is difficult to speculate about the decrease in prescription and nonprescription syringes, it is possible that during the baseline assessment, pharmacy staff did not have a good gauge on syringe sales because they had not been questioned about them before. Following participation in our study it is possible that they took more notice of syringe sales in their pharmacy and their initial estimates were overestimated the true number of syringes sold.
Table 2.
Pre- and Postintervention Pharmacy Staff Beliefs About Selling Syringes to Drug Users and Number of Syringe Sales and ESAP Customers by Study Arm, PHARM-Link 2009–2011.
| Study Arm | ||||||
|---|---|---|---|---|---|---|
|
|
||||||
| Baseline | 6-Month | 12-Month | p Value | |||
|
|
|
|||||
| Beliefs | Percentage | Trend | I versus Pa | I versus Sb | ||
|
| ||||||
| Business loss | ||||||
| Intervention | 0.80 | 2.47 | 5.41 | .0234 | .6392 | .6799 |
| Primary control | 0.77 | 1.16 | 3.13 | .1102 | ||
| Secondary control | 0.87 | 2.30 | 2.60 | .1770 | ||
| Crime | ||||||
| Intervention | 12.40 | 0 | 6.76 | .0319 | 1.000 | 1.000 |
| Primary control | 15.08 | 4.65 | 7.94 | .0288 | ||
| Secondary control | 19.47 | 8.33 | 6.49 | .0026 | ||
| Improper syringe disposal | ||||||
| Intervention | 5.60 | 3.70 | 4.00 | .2807 | 1.000 | 1.000 |
| Primary control | 2.31 | 4.65 | 4.69 | .1708 | ||
| Secondary control | 6.90 | 7.06 | 3.90 | .2127 | ||
| Community loitering | ||||||
| Intervention | 36.67 | 30.67 | 15.49 | .0012 | .0624 | .0491 |
| Primary control | 37.93 | 28.40 | 32.81 | .1873 | ||
| Secondary control | 36.27 | 26.51 | 29.33 | .1405 | ||
| Encourages drug use | ||||||
| Intervention | 38.84 | 27.63 | 22.97 | .0081 | .6519 | .5911 |
| Primary control | 31.97 | 31.17 | 22.22 | .0997 | ||
| Secondary control | 29.20 | 26.74 | 26.67 | .3422 | ||
| Reduces HIV transmission | ||||||
| Intervention | 82.40 | 88.89 | 89.19 | .0741 | .7201 | .3651 |
| Primary control | 77.52 | 83.13 | 92.19 | .0060 | ||
| Secondary control | 81.03 | 88.24 | 86.84 | .1126 | ||
|
Median (Range) |
||||||
| Prescription syringes sold/week | ||||||
| Intervention | 500 (200–1,000) | 300 (100–700) | 200 (0.5–500) | <.0001 | .3307 | .8832 |
| Primary control | 500 (300–1,000) | 500 (100–800) | 300 (10–500) | .0003 | ||
| Secondary control | 500 (300–1,000) | 300 (100–600) | 150 (3–500) | <.0001 | ||
| ESAP syringes sold/week | ||||||
| Intervention | 20 (5–50) | 10 (3–30) | 15 (4.5–35) | .3794 | .3316 | .2970 |
| Primary control | 20 (10–40) | 13.5 (3–25) | 10 (2–50) | .0530 | ||
| Secondary control | 20 (10–30) | 15 (4–30) | 10 (3–30) | .0018 | ||
| ESAP customers/month | ||||||
| Intervention | 10 (5–20) | 15 (6–30) | 10 (4–25) | .9242 | .2706 | .3580 |
| Primary control | 10 (6–20) | 20 (8–50) | 15 (5–25) | .2112 | ||
| Secondary control | 10 (5–20) | 15 (6–50) | 10 (5–20) | .7891 | ||
Note. ESAP = Expanded Syringe Access Program; PHARM-Link = Pharmacists as Resources Making Links to Community Services.
I versus P p values represent between-group differences of the intervention and primary control group study arms at 12-month study visit.
I versus S p values represent between-group differences of the intervention and secondary control group study arms at 12-month study visit.
Table 3.
Unadjusted and Adjusted Associations of Pharmacy Staff Beliefs Between Intervention and Control Groups, PHARM-Link 2009–2011.
| Community Loitering | PR (95% Confidence Interval) |
||
|---|---|---|---|
| Model 1 | Model 2 | Model 3 | |
|
| |||
| Intervention | 0.39 [0.18, 0.83]** | 0.46 [0.19, 1.11]* | 0.42 [0.17, 1.04]* |
| Primary control | 0.80 [0.48, 1.32] | 1.15 [0.62, 2.13] | 1.12 [0.60, 2.07] |
| Secondary control | Ref | Ref | Ref |
Note. PHARM-Link = Pharmacists as Resources Making Links to Community Services; PR = prevalence ratio. Model 1—Association accounting for clustering of pharmacy staff in pharmacies, Model 2—association adjusted for clustering of pharmacy staff in pharmacies and baseline differences, Model 3—association adjusted for clustering of pharmacy staff in pharmacies, baseline differences, and race.
p ≤ .10.
p ≤ .05.
p ≤ .01.
Discussion
The major finding of this study is that after contributing substantial time and effort into delivering HIV risk reduction information and providing additional social and medical referrals to IDU syringe customers, positive IDU attitudes among pharmacy staff did not wane and improved in some instances over time. While only a marginally significant decrease in negative attitudes persisted after adjustment, the perception that “community loitering would increase as a result of selling syringes to IDUs” demonstrated a significant decreasing trend over time, with no significant decrease observed in the control arms. We fully acknowledge that our intervention effect with respect to attitudes about IDUs is modest at best; however, it remains noteworthy given the high proportion of positive attitudes and pharmacy practices at baseline. These findings suggest that expanding services to IDU syringe customers within a profession that has had relatively limited interaction with heavy illegal drug using populations is not only feasible but also had no negative impact on pharmacy staff attitudes or pharmacy practices including prescription sales and nonprescription syringe sales. Although no significant differences by study arm were observed with respect to pharmacy practice, there were significant decreasing trends in syringe sales observed in both control arms while syringe sales remained constant over time in the intervention arm.
These results are complimentary to previous findings of this intervention that showed substantial increases in support of selling nonprescription syringes to IDUs in pharmacies (Crawford et al., 2013). Although it required substantial effort and time from pharmacy staff, training pharmacy staff about drug dependence may have influenced pharmacy staff beliefs about IDUs and how they interact with the community. Pharmacy staff effectively extended social and medical service referrals to IDUs and referred them to participate in this study, including scheduling appointments and reminding study participants of their upcoming visits during subsequent syringe purchase visits. For example, pharmacy staff distributed 1,423 safe injection packets each of which included a personal sharps disposal container, four alcohol pads, several cotton balls, four male condoms, two female condoms, one cooker, one tourniquet, two sterile (5 mL) water bottles and multilingual information booklets on local service providers, drug treatment options, safe injection tips, disposal options, and HIV and Hepatitis C testing and treatment information. This level of contact and discussion during the syringe sale could explain increased perceptions of business loss in the intervention group. Yet changing the context of the pharmacy staff and patient/customer relationship to one that increases discussion and allows for the provision of additional services has potential to translate into increased access to services, particularly in instances where pharmacist–clinician relations are well established around patient care (Guthrie, Young, Williams, Boyd, & Kintner, 2002; Haines et al., 2011; Yen, Ragland, Greiner, & Fisher, 1999). These data demonstrated detrimental impact neither on delivery of services to IDUs nor on attitudes about delivering services to drug users from pharmacy staff. Future studies should examine if and how pharmacies can play a more central role in health care delivery, particularly those facing challenges in regularly accessing care. Such studies should note whether these stronger relationships result in more constant and steady business relationships overall. Pharmacy-based public health services performed among this vulnerable population (Crawford et al., 2011; Fuller et al., 2002; Rivera et al., 2010; Vlahov et al., 2003) denote potential for scale-up of this effort and similar pharmacy services with other populations with unmet health care needs. While we spent significant resources ensuring that pharmacy staff adhered to study protocols, we found that educating and training pharmacy staff within a harm reduction framework about substance use and how to engage their IDU customers was manageable with the training materials we developed which are available on request. Thus, this intervention has the potential to be disseminated more widely, with little to no costs on a larger scale. Moreover, offering other services, specifically related to HIV primary prevention and acute treatment services (Ayanian, Weissman, Schneider, Ginsburg, & Zaslavsky, 2000; Branson, 2007; Liddicoat et al., 2004) in a pharmacy setting is possible where the financial incentives are high and are often subsidized for low-income individuals through programs such as the AIDS Drug Assistance Program.
While significant trends in attitudes and practices were observed over time providing support for a positive intervention impact, only a marginally positive intervention effect was observed when direct comparisons were made by intervention/control status. It is entirely plausible that some biases may have contributed to this dampened effect. For example, contamination of the primary control group may have also occurred due to regular contact with the public health–minded research team. To minimize this, we also used a secondary control group who had minimal contact with study staff as a comparison group. Pharmacy staff turnover within the pharmacy and resultant loss to follow-up of pharmacies and pharmacy staff may have also affected the results. Most pharmacies remained in the study despite changes in pharmacy staff over time. While there were slight differences in loss to follow-up by study arm (i.e., more pharmacies in the primary control group dropped out) these differences were not significant at the pharmacy level or pharmacy staff level (data not shown). We also chose to present results from an intent-to-treat analysis, but when performing a per-protocol analysis of the intervention effect among those who participated in the entire study, the results remained unchanged. Furthermore, there is high potential for selection bias in our sample of pharmacies that agreed to participate versus those who did not. There were differences in participation by borough where more pharmacies in the Bronx and Manhattan declined, and the reasons for this are unclear. Selection bias may have also influenced pharmacies with more positive beliefs about ESAP to participate in our study and make it more difficult to detect an intervention effect. Overall, strong public health-mindedness as indicated by the relatively high proportions of positive attitudes at baseline provides solid evidence of this bias. Moreover, given that the results of the structural intervention presented here took place within the framework of ESAP, a robust and well-established structural intervention, it may have further affected our ability to detect an effect. It is important to note however, that structural interventions may be needed on multiple levels within a societal structure to produce an effect and to ensure that disparities in access to structural changes do not result. This was particularly true for ESAP, which has been shown to have lower utilization among minority IDUs (Deren et al., 2006; Des Jarlais et al., 2002; Fuller et al., 2004). Thus, the implementation of this structural intervention in high drug activity minority neighborhoods may contribute to the success of ESAP and highlight intervention strategies to improve the implementation of ESAP in these communities. Furthermore, external validity of the study may also be limited to pharmacies in high drug activity neighborhoods in New York City, which, in general, may be characterized by more public health-minded pharmacy staff given the extensive evaluations that have been conducted among ESAP pharmacies since the program began (Coffin et al., 2002; Coffin et al., 2004; Fuller et al., 2002; Vlahov et al., 2003). And yet, the observation of a marginal intervention effect in the face of selection bias remains noteworthy as well as the additional increases in positive attitudes following our intervention suggesting that additional training can have further impact.
Conclusion
Structural interventions have been recommended for targeting multiple behaviors and outcomes. This structural-level pharmacy intervention targeted community, pharmacy practice, and individual pharmacy staff–level beliefs about drug use and implemented a large-scale pharmacy-randomized intervention to examine impact on pharmacy practice and pharmacy staff beliefs and attitudes toward drug users. These intervention findings highlight some potential to improve pharmacy staff attitudes toward services for drug users over time, even when baseline-level beliefs are generally positive, and when time and effort on behalf of the pharmacy staff are required. Changes in beliefs about IDUs and building rapport between pharmacy staff and IDUs have the potential to provide another point of HIV prevention services for IDUs. While acknowledging key limitations in this study, we recognize that extension of these findings to other U.S. cities where similar pharmacy syringe access programs exist is a natural extension of these data, however, with caution. Other cities may have lower acceptance rates of extended practice; however, identifying a large level of pharmacy support for such programs is not necessarily required with only 40% of New York City pharmacies supporting ESAP since the program began (New York State Department of Health, 2010). Thus, with modest support, additional pharmacy staff training is feasible to promote positive interactions between pharmacy staff and IDUs and to reduce negative beliefs about IDUs and, warrants investigation in other settings where intervention effects may be more likely if baseline positive attitudes are lower relative to New York City.
Acknowledgments
The authors thank the Pharmacies As Resources Making Links to Community Services (PHARM-Link) research and staff, the PHARM-Link Community Working Group (Wesley Badillo, New York State Department of Health AIDS Institute; Ann Boyer, Mount Sinai Medical Center; Dwight Brown, VIP Community Services; Nadine Ranger, Brooklyn AIDS Task Force; Jose Martin Garcia Orduna, East Harlem HIV Care Center; Laurell Lasenburg, Bronx District Public Health Office; Stuart Feldman, Touro College of Pharmacy; Camagu Tuswa, Swan Pharmacy), and PHARM-Link participants.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by the National Institute on Drug Abuse (R01 DA022144).
Footnotes
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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