Harm Reduction Coalition Policy Statement on Auto-Disable Syringes

Harm Reduction Coalition Policy Statement on Auto-Disable Syringes Auto-disable syringes are inappropriate for controlling epidemics of HIV, hepatitis C, and other blood-borne viruses among people who inject drugs. Injection safety policies aimed at increasing the safety of immunization and therapeutic injections should promote policy environments that do not inadvertently restrict access to standard disposable syringes and thereby increase HIV risk behavior among injection drug users. Auto-disable syringes will increase transmission of blood-borne diseases among injecting drug users.

Transmission of blood-borne illnesses in health care settings remains a major health concern in many countries, including those in Africa and Asia.1 Government regulations banning the import of standard syringes, however, encourage needle sharing among those who inject drugs outside the medical setting, and will impede scale-up of HIV prevention for injection drug users. Scaling up access to sterile syringes for people who inject drugs is an urgent and, as yet, unmet global priority in preventing HIV and other blood-borne viruses.

The 2009 World Health Organization (WHO) progress report Towards universal access: scaling up priority HIV/AIDS interventions in the health sector, notes that current needle and syringe access programs in South and Southeast Asia distribute fewer than 14% percent of internationally recommended targets. Despite reports of HIV transmission through injection drug use in multiple countries of Africa, needle and syringe programs remain unavailable there, with the exception of Mauritius.2 Although there are examples of scale-up efforts in many settings, injecting drug users continue to face legal and social barriers in accessing sterile syringes and drug treatment services.3 Exclusive use of auto-disable syringes remains central to efforts to control blood-borne infections in health care settings. In 1999, WHO, UNICEF, and the United Nations Population Fund issued a joint statement urging that “by the end of 2001, all countries should use only auto-disable syringes or syringes which are designed to be sterilized.

Standard disposable syringes should no longer be used for immunization.”4 Thirteen other organizations, including the United States Centers for Disease Control and Prevention and the International Federation of Red Cross and Red Crescent Societies, endorsed the joint statement. UNICEF announced that as of 2001, it would no longer enter into procurement service contracts for standard disposable syringes. In 2007, WHO released guidelines for

1

Schmid GP, Buvé A, Mugyenyi P, Garnett GP, Hayes RJ, et al Transmission of HIV-1 infection in sub-Saharan Africa and effect of elimination of unsafe injections. Lancet. 2004 Feb 7;363(9407):482-8.

2 Mathers BM, Degenhardt L, Ali H, Wiessing L, Hickman M, et al; 2009 Reference Group to the UN on HIV and Injecting Drug Use. HIV prevention, treatment, and care services for people who inject drugs: a systematic review of global, regional, and national coverage. Lancet. 2010 Mar 20;375(9719):1014-28.

3 Towards universal access: scaling up priority HIV/AIDS interventions in the health sector : progress report 2009. Geneva, World Health Organization, 2009.

4 Safety of Injections: WHO-UNICEF-UNFPA joint statement on the use of auto-disable syringes in immunization services.

manufacturers stating that single-use injection devices with reuse prevention features prequalified for procurement under the Performance, Quality, Safety (PQS) system used by United Nations agencies.5 WHO identifies four types of syringes promoting injection safety and designated as essential health technologies: auto-disable syringes, syringes which break the plunger upon use, needle stick prevention syringes, and retractable syringes.6 Recognizing that health care workers are also at risk of occupational exposure to blood borne diseases, some countries have instituted the use of safety syringes in health care settings, though many of the auto-disable syringes do not include an adequate mechanism protecting health care workers. Several countries, however, are now moving to significantly restrict the import of all but auto-disable syringes including Uganda, Burkina Faso, India, Nigeria, Tanzania, and Democratic Republic of Congo. These policies will have the unintended dangerous consequence of reducing the overall number of syringes available outside of medical settings, thereby promoting sharing of equipment by injection drug users and fostering transmission among this population of HIV and other blood-borne viruses.

Drug preparation and injection outside the medical setting routinely involves more than one retraction or depression of the syringe plunger, making auto-disable syringes inappropriate.

Many needle and syringe access programs serving injection drug users have reported that auto-disable syringes are rejected by their clients. In a study commissioned by the US Congress in 1992, Des Jarlais et al. found that all types of auto-disable needle/syringe devices assessed could be reused, either by disabling the mechanism or by scavenging the parts.7 Alternately, two or more people might circumvent an auto-disable mechanism by each injecting with a single syringe before the disabling mechanism is triggered. The report characterized these devices as “Difficult-to-Reuse” rather than “non-reusable.” Indeed, before disposable syringes were readily available, IDUs improvised their own injection equipment from needles and medicine dropper or baby pacifiers. Disabled or scavenged parts may be more difficult to clean, as they may contain more recesses which retain blood following injection. Indeed, compelling laboratory and epidemiological evidence indicates that insulin syringes with non-detachable needles are less likely to transmit viruses due to a lesser amount of retained blood and consequently a shorter period of viability for viruses.8,9 The use of auto-disable syringes to prevent transmission of blood-borne illnesses among IDUs has been proposed and rejected in the Netherlands, Australia and the United States.7 A mathematical modeling study by Caulkins et al. found that replacing standard syringes with auto-disable syringes would be likely to increase the incidence of HIV among injection drug users.10 If auto-disable syringes were truly single use, each injector would require over

5

Pre-qualification of single-use injection devices under the PQS system: Guidelines for manufacturers. WHO/PQS/E08E13/GUIDE.1.4. Geneva, World Health Organization, 2008.

6 Safe syringes for injection safety 7 U.S. Congress, Office of Technology Assessment, Difficult-to-Reuse Needles for the Prevention of HIV Infection Among Injecting Drug Users--Background Paper, OTA-IW-H- 103 (Washington, DC: U.S. Government Printing Office, October 1992).

8 Bobashev GV, Zule WA. Modeling the effect of high dead-space syringes on the human immunodeficiency virus (HIV) epidemic among injecting drug users. Addiction. 2010 Aug;105(8):1439-47.

9 Paintsil E, He H, Peters C, Lindenbach B, Heimer R. Survival of Hepatitis C Virus in Syringes: Implication for Transmission among Injection Drug Users. J Infect Dis. 2010 Oct 1;202(7):984-90.

10 Caulkins, J P., Kaplan EH, Lurie P, O’Connor T, Ahn S, “Can Difficult-to-Reuse Syringes Reduce the Spread of HIV Among Injection Drug Users?” Interfaces 28:3 1998 pp23-33

700 new syringes a year, assuming a low average of 2 injections per day. This figure far exceeds the amount of syringes currently available for IDUs through syringe access programs, and the considerable expense of maintaining such supplies would be unfeasible even for well-funded programs. Therefore the supply of auto-disable syringes would be insufficient to meet the needs of injectors, and a residual pool of standard syringes would remain in circulation. Assuming a stable number of syringes in the drug injector population, the average number of injections for each non-auto-disable syringe would necessarily increase after the introduction of auto-disable syringes. Thus the risk of exposure to an infectious needle would correspondingly rise when auto-disable syringes are introduced.

Restricting syringe access programs that target IDUs to providing only auto-disable syringes would consequently increase the risk of infection with HIV and other blood-borne viruses.

Policy makers, implementers, and international groups focused on injection safety in health care settings must consider the needs and realities of people who inject drugs in formulating safe injection policies and programs. Laws, procurement guidelines, and import restrictions which limit syringe availability to only auto-disable syringes will have devastating consequences on the transmission of HIV and other blood-borne viruses among IDUs. Comprehensive injection safety policies and programs must balance the needs of injection drug users with those of the patients and health care workers at risk of infection in health care settings. Auto-disable syringes are not appropriate for people who inject drugs, and policy environments should support and scale up access to standard needles and syringes for this population. A combination of education, adequate supply of appropriate syringes, ready access to sharps containers, and judicious use of manual and automatic needle sheathing devices can be used to protect health care workers, recipients of therapeutic injections and injection drug users.

9/2010