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AIDS:
Structural Factors in HIV Prevention

Syringe laws and pharmacy regulations are structural constraints on HIV prevention in the US

Taussig, Jennifer A.; Weinstein, Beth; Burris, Scott; Jones, T. Stephen

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From the Division of HIV/AIDS Prevention - Intervention Research and Support, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.

Address requests for reprints to: Jennifer Taussig, National Center for HIV, STD, and TB Prevention, Office of Communications, Centers for Disease Control and Prevention, Mail Stop E-06, Atlanta, GA 30333, USA.

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Abstract

Objective: To review the legal and regulatory barriers that restrict pharmacy sales of syringes to injection drug users (IDUs) and to discuss how reducing these barriers can facilitate access to sterile syringes for IDUs and improve HIV prevention.

Background: IDUs' access to sterile syringes from community pharmacies in the United States is limited by state laws and regulations governing syringe sales. Restricted availability of sterile syringes from pharmacies is a structural barrier that greatly impedes HIV prevention for IDUs, who often share and reuse syringes because they cannot obtain and possess sterile syringes. These high-risk behaviors contribute to the transmission of HIV and other blood-borne pathogens among IDUs, their sexual partners, and their children.

State experiences: In Connecticut, because of high HIV prevalence among IDUs, restrictive syringe laws were changed. After the legal changes in Connecticut, both pharmacy sales of syringes in areas of high drug use and purchases of syringes in pharmacies (reported by IDUs) increased, while syringe sharing (reported by IDUs) decreased. Maine and Minnesota have made similar changes in laws.

Conclusions: Increasing access to sterile syringes through pharmacies requires the repeal or modification of legal barriers. Pharmacy sale of syringes to IDUs is an inexpensive HIV prevention intervention with the potential to substantially reduce HIV transmission. Further studies are needed to document how changes to legal barriers can influence HIV prevention for IDUs.

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Introduction

The significant contribution of injection drug use to the transmission of HIV and other blood-borne pathogens, such as hepatitis B and C viruses among injection drug users (IDUs), their sexual partners, and their children, underscores the public-health importance of improving injection drug user access to sterile syringes [1-3]. The transmission of blood-borne pathogens among IDUs often results from the sharing and the reuse of blood-contaminated syringes and other injection paraphernalia [4-6].

IDUs often share and reuse injection equipment, including syringes, because of the barriers they encounter in trying to obtain and possess syringes [7-10]. Burris et al.'s review of current US state and local laws and regulations governing syringe sales found significant legal restrictions on pharmacy sales of syringes (Table 1) [11]. These restrictions include state prescription and drug paraphernalia laws. An earlier national survey also documented that pharmacy regulations and practice guidelines constitute significant barriers to syringe sales [12]. These barriers, which differ from state to state, significantly reduce IDUs' ability to purchase and possess sterile syringes. Efforts to increase injection drug user access to sterile syringes from pharmacies must address these restrictions. In addition to legal and regulatory barriers, the individual attitudes and moral beliefs of pharmacists affect syringe sales practices, and must be addressed when designing interventions to improve injection drug user access to sterile syringes from pharmacies [13,14].

Table 1
Table 1
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The legal barriers that restrict injection drug user access to sterile syringes from pharmacies are a good example of a structural barrier to HIV prevention. In this paper, we discuss these issues in the context of HIV prevention for IDUs and offer recommendations for improving such access.

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Legal barriers

Prescription laws and regulations in 10 US states and the Virgin Islands require customers to provide a valid medical prescription to make any purchase of syringes. In Connecticut and Maine, syringe prescription laws were partially repealed to allow for the sale of syringes without a prescription to adults (Maine) and the sale of up to 10 syringes without a prescription (Connecticut). Most states have laws that criminalize the sale or possession of drug paraphernalia, including syringes, for use in the consumption of illegal drugs (Table 1) [11]. Drug-paraphernalia laws contribute to syringe sharing and other risk-taking behaviors among IDUs who prefer not to carry syringes for fear of arrest [8,10].

Pharmacy regulations and practice guidelines on syringe sales may also restrict injection drug user access to sterile syringes. These regulations differ in their wording and their influence on pharmacists' syringesales practices [12]. They are typically made by a pharmacy board or state health agency through a rule-making process that does not require legislative action or approval. For example, in Georgia, a Board of Pharmacy regulation states that "no injectable [sic] syringe shall be sold by a person having reasonable cause to believe that it will be used for an unlawful purpose" [15].

In many states, pharmacy regulations and drug paraphernalia laws do not definitively answer the question of whether or when pharmacy sales of syringes to IDUs are legal; there is tremendous latitude in the interpretation of language commonly found in these laws such as 'lawful' or 'legitimate medical purpose'. Furthermore, there is substantial variation in pharmacists' familiarity with the wording of these laws and regulations, and the extent to which that wording influences their sales practices.

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Policy approaches that support sterile syringe access and removal of legal barriers

There has been increasing recognition that providing IDUs with access to sterile syringes for the purpose of preventing the transmission of HIV and other blood-borne pathogens is a legitimate medical purpose, and thus is good public health and medical practice [16]. Policy statements and recommendations from public health, medical, and pharmacy organizations have endorsed this concept [16-18]. However, widespread implementation will require the removal of legal barriers to the pharmacy sale of syringes in most states.

In 1997, the US Public Health Service recommended that drug users who continue to inject use a new sterile syringe for each injection, and that such syringes be obtained from reliable sources such as pharmacies [16]. In 1997, the American Medical Association House of Delegates approved a series of new American Medical Association policies including "that the AMA strongly encourage state medical associations to initiate state legislation modifying drug paraphernalia laws so that injection drug users can purchase and possess needles and syringes without a prescription" [17].

In 1999, the American Pharmaceutical Association adopted a new policy stating that the "APhA encourages state legislatures and boards of pharmacy to revise laws and regulations to permit the unrestricted sale or distribution of sterile syringes and needles by or with the knowledge of a pharmacist in an effort to decrease the transmission of blood-borne diseases [18]." This policy is a product of the American Pharmaceutical Association: (i) understanding the public-health rationale for improving injection drug user access to sterile syringes; (ii) recognizing the legitimate medical purpose that sterile syringes serve in preventing the transmission of blood-borne pathogens; and (iii) embracing the important public-health role of pharmacists.

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A structural intervention: removing barriers to syringe sales in pharmacies

Although the sale of sterile syringes to IDUs in retail pharmacies is an important HIV-prevention community intervention with increasing recognition in the United States over the past 7 years, there are still relatively few US cities where IDUs can readily obtain syringes from pharmacies. In contrast, in the late 1980s, Australia and a number of European countries permitted pharmacy sales of sterile syringes to IDUs [19-21].

Pharmacies are conveniently located throughout many communities, and have extended days and hours of operation, making them good locations for IDUs to obtain sterile syringes. Although syringe-exchange programs have been the dominant US intervention for providing IDUs with access to sterile syringes, these programs have limitations. Many urban areas with substantial numbers of IDUs do not have syringe-exchange programs [22]. Furthermore, even in cities where syringe-exchange programs are operating, their limited hours and locations of operation restrict injection drug user acquisition of sterile syringes. Given such limitations, it is important that there be other avenues by which IDUs can acquire sterile syringes, and pharmacies are a community resource where such access could easily be provided.

Only a handful of US states have modified or repealed the legal restrictions on syringe sales to IDUs. However, a few studies have demonstrated that modifying the restrictive laws and pharmacy regulations governing syringe sales can increase pharmacy sales of syringes to IDUs.

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Case studies

Connecticut

Like many other states, Connecticut adopted laws in the 1970s and 1980s that restricted the sale of syringes in pharmacies without a prescription, and made the possession of syringes that had been obtained without a prescription illegal. In 1992, in response to clear evidence that injection drug use was the driving force in the state's AIDS epidemic, the Connecticut General Assembly passed legislation allowing over-the-counter sales (without a prescription) of as many as 10 syringes and possession by individuals of as many as 10 clean syringes without drug residue. After the law went into effect on 1 July 1992, two studies were conducted to measure the impact of these legislative changes on pharmacy syringe sales and on injection drug user injection-related behaviors [23,24].

The study of pharmacy practices used a prospective surveillance system and measured whether syringe sales increased after the changes in the syringe law [23]. Researchers chose eight pharmacies in neighborhoods where injection drug use was prevalent in the city of Hartford and recruited them to record the numbers of syringes that were sold with and without prescriptions after 1 July 1992. To allow for the comparison of communities with high and low prevalence of drug use, five pharmacies in the adjacent suburb of Wethersfield, where injection drug use is less prevalent, were also enrolled.

Five pharmacies in Hartford sold nonprescription syringes continually from 1 July 1992 to 30 June 1993. Because of negative experiences associated with selling syringes to IDUs, the three other Hartford pharmacies stopped selling nonprescription syringes during this period. In the five pharmacies, the total number of nonprescription syringes sold per month increased from 460 in July 1992 to 2482 in June 1993. The five Wethersfield pharmacies sold an average of 210 nonprescription syringes per month, and sales were stable throughout the year. These sales patterns suggest that the steady increase in syringe sales in Hartford was likely due to purchases by IDUs.

To determine the effect of the legal changes on the behavior of IDUs, two cross-sectional surveys were conducted of active IDUs recruited from drug-treatment programs, correctional facilities, and health departments in four cities [24]. The first survey was conducted from August to November 1992 to characterize injection drug user behaviors in June 1992, just before the laws were implemented. A second survey using the same sampling methods was conducted with different IDUs in the four cities from March to June 1993 in order to determine their behaviors after the law changed; this survey focused on injection drug user behavior 30 days before the interview.

Findings from the two surveys revealed that, after the syringe law changes: (i) fewer IDUs reported syringe sharing during the past 30 days (31% versus 52%); (ii) fewer IDUs reported obtaining syringes from the street (74% versus 88%); (iii) more IDUs reported ever having purchased a syringe in a pharmacy (90% versus 47%); and (iv) fewer IDUs reported ever having shared syringes (52% versus 68%).

In 1994, to determine the effect of the legislative changes on pharmacy sales and pharmacy practices, a mail survey was conducted with all current pharmacy managers in the five largest cities in Connecticut and with a random sample of current pharmacy managers in the rest of the state [14]. In the five largest cities, 32% of pharmacists said that they sold syringes without a prescription to any customer, and 54% said they would sell at their discretion. In the other areas of the state, 40% said they would sell to any customer, and 52% said they would sell at their discretion. Most pharmacists listed safety issues, such as concerns about robbery and discarded syringes in or around the pharmacy, as very important in their decision regarding syringe sales without a prescription.

Of the pharmacists who were allowed to sell syringes to any customer (some pharmacies were part of a chain in which corporate policy controlled the decision about nonprescription sales) and of the pharmacists who sold syringes at their discretion, 31.4% and 18.1%, respectively, reported that they were very willing to sell syringes to IDUs. Among pharmacists who sold syringes without a prescription to any customer, the perception that syringe sales benefit the health and wellbeing of the community was the only influence independently associated with managers' support for nonprescription sales to IDUs. Among pharmacists who sold syringes at their discretion, concerns about the risk that used syringes would be discarded around pharmacies and that syringe sales would lead to increased crime, drug use, and customer discomfort reduced their support to sell syringes to IDUs.

Although many pharmacists reported that syringes were sold without a prescription after the changes in the syringe laws, the survey indicated that relatively few syringes were sold by pharmacies statewide compared with the millions of syringes that pharmacies and syringe-exchange programs would need to provide Connecticut IDUs to ensure that they had a sterile syringe for each injection [25]. This finding suggests that simply changing syringe laws will not necessarily result in a dramatic increase in sales by pharmacists or a large increase in requests for syringes by IDUs. Education of pharmacists and IDUs is necessary to complement the legal changes, and Connecticut has undertaken such efforts [26].

Connecticut's experience shows that legislators will respond to public-health problems, that pharmacies are acceptable to IDUs as a source of syringes, and that pharmacists are willing to sell sterile syringes to IDUs who do not have prescriptions. The legal changes in Connecticut have been a model for other states.

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Maine

In 1993, the Maine legislature passed Public Law 394, which removed the prescription requirement for syringe sales. However, a 1995 evaluation of the effect of this law on pharmacists' syringe sales practices revealed that many pharmacists were still not selling syringes to suspected IDUs because of concerns about the legality of selling syringes to IDUs who could not legally possess syringes unless they had been obtained by prescription [27].

In response to these concerns, the Maine Bureau of Health, the Maine Pharmacy Association, the Maine Office on Substance Abuse, and the Maine Association of Chiefs of Police collaborated to address this issue [28]. These groups sponsored a bill to remove the criminal penalties for the possession of 10 or fewer syringes. The bill was introduced and passed in 1997. Maine's experience highlights: (i) the importance of addressing the concerns of pharmacists regarding the sale of syringes to IDUs; (ii) the need to modify laws that both restrict the sale and possession of syringes; and (iii) the crucial role of collaboration among pharmacy, law enforcement, and substance-abuse treatment organizations.

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Minnesota

In 1997, Minnesota amended the state syringe and drug paraphernalia statutes to allow for the pharmacy sale of up to 10 syringes without a prescription and for possession of up to 10 unused syringes at any time [29]. The primary goal of the legislative changes was to reduce HIV transmission among IDUs. After the legislative changes went into effect (July 1998), Minnesota instituted the Pharmacy Syringe/Needle Access Initiative [30]. Pharmacy participation in the initiative is voluntary and requires certification to the commissioner of health that the pharmacy supports proper disposal of used syringes and needles. The Minnesota Pharmacy Association and the Minnesota Health Department actively supported the bill, and jointly encourage pharmacists to sell syringes to IDUs to help prevent the transmission of HIV and other blood-borne pathogens.

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Conclusion

Pharmacies are good locations for public-health interventions because of their convenient locations and widespread availability to many people. The pharmacy sale of syringes to IDUs is an inexpensive public-health intervention that has the potential to contribute substantially to preventing the transmission of HIV and other blood-borne pathogens. Removing the barriers that restrict the pharmacy sale of syringes and educating pharmacists about the important role they can play in helping to prevent the transmission of blood-borne pathogens are low-cost interventions with the potential to save lives. The examples from Connecticut, Maine, and Minnesota illustrate the importance of fostering collaboration among public health, pharmacy, medicine, law enforcement, substance-abuse treatment, and other groups to address the many issues raised by the pharmacy sale of syringes to IDUs.

Further studies are needed to document the public-health effect of changing restrictive pharmacy laws and regulations. The support for these interventions from the leading US public health, medical, and pharmacy organizations reinforces the argument that selling sterile syringes to IDUs is a legitimate medical purpose, and therefore is an appropriate intervention to be carried out in community pharmacies.

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References

1. Centers for Disease Control and Prevention. HIV/AIDS Surveillance Rep 1999, 11:1-42.

2. Levine OS, Vlahov D, Koehler J, Cohn S, Spronk AM, Nelson KE. Seroepidemiology of hepatitis B virus in a population of injecting drug users. Am J Epidemiol 1995, 142:331-341.

3. Alter MJ, Moyer LA. The importance of preventing hepatitis C virus infection among injection drug users in the United States. J Acquir Immune Defic Syndr Hum Retrovirol 1998, 18(suppl 1):S6-S10.

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5. Schoenbaum EE, Hartel D, Selywn PA, et al. Risk factors for HIV-1 infection in intravenous drug abusers. N Engl J Med 1989, 321:874-879.

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9. Rich JD, Dickinson BP, Case P, et al. Strict syringe laws in Rhode Island are associated with high rates of re-using syringes and HIV risks among IDUs [letter]. J Acquir Immune Defic Syndr Hum Retrovirol 1998, 18(suppl 1):S140.

10. Case P, Meehan T, Jones TS. Arrests and incarceration of injection drug users for syringe possession in Massachusetts: implications for HIV prevention. J Acquir Immune Defic Syndr Hum Retrovirol 1998, 18(suppl 1):S71-S75.

11. Burris S, Lurie, P, Abrahamsom D, Rich J. Physician prescribing of sterile injection equipment to prevent HIV infection: Time for action. Ann Internal Med 2000 (in press).

12. Gostin LO, Lazzarini Z, Jones TS, Flaherty K. Prevention of HIV/AIDS and other blood-borne diseases among injection drug users: a national survey on the regulation of syringes and needles. JAMA 1997, 277:53-62.

13. Gleghorn, AA, Gee G, Vlahov D. Pharmacists' attitudes about pharmacy sale of needles/syringes and needle exchange programs in a city without needle/syringe prescription laws. J Acquir Immune Defic Syndr Hum Retrovirol 1998, 18(suppl 1):S89-S93.

14. Wright-De Agüero L, Weinstein B, Jones TS, Miles J. Impact of the change in Connecticut syringe prescription laws on pharmacy sales and pharmacy managers' practices. J Acquir Immune Defic Syndr Hum Retrovirol 1998, 18(suppl 1):S102-S110.

15. Ga. Comp. R. & Regs. r.480-10-.13 (1987).

16. US Public Health Service. Medical advice for persons who inject illicit drugs. HIV Prevention Bulletin. Atlanta, GA: Centers for Disease Control and Prevention; 1997.

17. Lundberg GD. New winds blowing for American drug policies [editorial]. JAMA 1997, 278:946-947.

18. American Pharmaceutical Association. Report of the 1999 Session of the APhA House of Delegates. San Antonio, TX: American Pharmaceutical Association; 1999.

19. Tsai R, Goh EH, Webeck P, Mullins J. Prevention of human immunodeficiency virus infection among intravenous drug users in New South Wales, Australia: the needles and syringe distribution programme through retail pharmacies. Asia Pac J Public Health 1988, 2:245-251.

20. Ingold FR, Ingold S. The effects of the liberalization of syringe sales on the behaviour of intravenous drug users in France. Bull Narcotics 1989, 41:67-81.

21. Glanz A, Byrne C, Jackson P. Role of community pharmacies in prevention of AIDS among injecting drug misusers: findings of a survey in England and Wales. BMJ 1989, 9:1076-1079.

22. Centers for Disease Control and Prevention. Update: syringe exchange programs - United States, 1997. MMWR 1998, 47:652-655.

23. Valleroy LA, Weinstein B, Jones TS, et al. Impact of increased legal access to needles and syringes on community pharmacies needle and syringe sales - Connecticut 1992-1993. J Acquir Immune Defic Syndr Human Retrovirol 1995, 10:73-81.

24. Groseclose SL, Weinstein B, Jones TS, et al. Impact of increased legal access to needles and syringes on practices of IDUs and police officers - Connecticut, 1992-1993. J Acquir Immune Defic Syndr Human Retrovirol 1995, 10:82-89.

25. Lurie P, Jones TS, Foley J. A sterile syringe for every drug user injection: how many injections take place annually, and how might pharmacists contribute to syringe distribution? J Acquir Immune Defic Syndr Hum Retrovirol 1998, 18(suppl 1):S45-S51.

26. Weinstein B, Toce P, Katz D, Ryan LL. Peer education of pharmacists and supplying pharmacies with IDU packets to increase injection drug users access to sterile syringes in Connecticut [letter]. J Acquir Immune Defic Syndr Hum Retrovirol 1998, 18(suppl 1):S146-S147.

27. Case P, Beckett GA, Jones TS. Access to sterile syringes in Maine: pharmacy practice after the 1993 repeal of the syringe prescription law. J Acquir Immune Defic Syndr Hum Retrovirol 1998, 18(suppl 1):S94-S101.

28. Beckett GA, Galena R, Shields D, et al. Maine removed criminal penalties for syringe possession in 1997 after allowing sale of syringes without a prescription in 1993 [letter]. J Acquir Immune Defic Syndr Hum Retrovirol 1998, 18(suppl 1):S145-S146.

29. Minnesota Stat §151.40, 325F.785, 145.924 (1998).

30. Minnesota Department of Health. Minnesota Pharmacy Syringe/Needle Access Initiative [brochure]. St. Paul, MN: Minnesota Department of Health; 1998.

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Section Description

Based on presentations from Structural Barriers and Facilitators in HIV Prevention, a meeting sponsored by the Centers for Disease Control and Prevention on February 22-23, 1999

This publication is sponsored by the Behavioral Intervention Research Branch; Division of HIV/AIDS Prevention; National Center for HIV, STD, and TB Prevention; U.S. Centers for Disease Control and Prevention.

The Editors of this supplement wish to acknowledge the referees who provided peer reviews of the manuscripts.

Statements of individual authors may not reflect the position of the Centers for Disease Control and Prevention.

Keywords:

HIV; injection drug users; HIV prevention/education; syringe access; pharmacy; syringe laws

© 2000 Lippincott Williams & Wilkins, Inc.

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