Balancing access and safety in prescribing opioid agonist therapy to prevent HIV transmission

HIV infections among people who inject drugs (PWID) continue to rise and present unique delivery challenges in low- and middle-income countries. Opioid agonist therapy (OAT) programs struggle to balance treatment efficacy and safety with the need to scale-up services to meet demand and address public health concerns, including opioid dependence, overdose and HIV transmission. OAT programs struggle to balance treatment efficacy and safety with the need to adequately scale-up services to meet demand and address public health concerns, including opioid dependence, overdose and HIV transmission. This struggle is most pronounced in resource-constrained settings where OAT is nascent and where public acceptance is limited. Despite the overwhelmingly positive effects of OAT on quality of life, mortality and HIV-related transmission and treatment, only 8% of people who inject drugs (PWID) world-wide receive OAT 1. Overcoming constraints that result in ineffective OAT coverage will require medical, legal and economic alignment. Nearly 50 years of OAT experience provide us with sufficient guidance to expand this life-saving treatment safely, swiftly and economically. In Malaysia and Ukraine, PWID account for more than half of all new HIV infections, and HIV remains concentrated in key populations. Their experiences highlight the difficulty in striking a balance between accessibility and safety in resource-constrained settings where rapid and expansive OAT scale-up is essential. In Malaysia, buprenorphine and methadone were introduced in 2002 and 2005, respectively, but today only 17 455 (~10% of the estimated 170 000 PWID) receive them 2. Initially, buprenorphine was prescribed and dispensed by physicians without formal licensing, training or guidance and OAT was poorly supervised, resulting in widespread diversion and misuse, including injection of buprenorphine 3. In addition, OAT costs to patients in private settings in Malaysia are based on medication dosage, which has probably contributed to suboptimal dosage and decreased treatment efficacy. Changing from buprenorphine to buprenorphine/naloxone along with increased physician training and government regulation has reduced, but not eliminated, these problems 3, 4. In Ukraine, buprenorphine and methadone became available in 2004 and 2008, respectively. Since then, OAT expansion has been slow and inefficient, with only 2.7% of the estimated 310,000 PWID engaged in care 4. In Ukraine, stringent regulations, exorbitant costs and stigma have stifled OAT expansion. Government registration as a drug user is required before initiating OAT, often resulting in revocation of drivers’ licenses and impeding transportation to care and return to employment. Daily supervision conducted simultaneously by a specialized physician and nurse, limited dispensing locations and inconvenient hours further constrain OAT accessibility 5. Moreover, OAT licensing restricts receipt to the site of dispensation, resulting in medication discontinuation when patients are hospitalized, incarcerated or traveling. Police harassment of both OAT patients and staff further marginalizes treatment-seeking PWID and hinders HIV prevention efforts. Recent evidence suggests that both countries have made inadequate progress in OAT and HIV prevention scale-up 4. Despite decreasing HIV incidence and mortality globally, both Malaysia and Ukraine continue to experience rising epidemics and will require creative solutions to further expand OAT 6. The United Kingdom and the United States, resource-rich countries with long-standing OAT experience, offer crucial lessons in task-shifting, operations improvement and knowledge-sharing to countries with nascent OAT programs and limited resources. Task-shifting, defined by the World Health Organization as the process whereby ‘specific tasks are moved, where appropriate, from highly-qualified health workers to health workers with shorter training and fewer qualifications in order to make more efficient use of the available human resources for health’ 7, has already been applied successfully to HIV treatment in resource-constrained settings 8. Similarly, the United Kingdom employed this cost-cutting measure of task-shifting to expand the number of patients on OAT rapidly and safely through the use of community pharmacies 9. In the late 1990s, the United Kingdom issued new OAT guidelines in recognition of high rates of methadone misuse and overdose. Community pharmacies adapted to this framework of increased safety demands by supervising methadone administration, and local health authorities responded with increased remuneration for these services 9. Consequently, annual methadone-related deaths declined by 30.2%, from 268 deaths in 1997 to 187 in 2008, while the number of patients receiving methadone increased by 375% in that same time-period 9. Recent increases in methadone-related deaths in the United Kingdom, however, suggest the possibility of increased diversion and inappropriate OAT prescribing 10. Without proper training, monitoring and support, decentralized, community-based prescribing networks of controlled substances risk causing harm. Nevertheless, OAT coverage in the United Kingdom currently exceeds 63% of an estimated 264 072 PWID 11, 12. Although HIV transmission among PWID remains a concern in the United Kingdom, HIV prevalence among new initiates to drug injection has continued to remain low ~0.4% 13. In addition to task-shifting, adoption of an operations-improvement model, often used in business management systems, may reduce costs and improve safety and health. The Network for the Improvement of Addiction Treatment (see www.NIATx.net) provides a treatment-improvement process, including technical support and education in businesses processes (e.g. admission procedures, telephone systems and human resources support) to addiction clinics globally to drastically eliminate access barriers, reduce no-show rates and increase OAT retention 14. In the United States, interventions to overcome the dearth of addiction expertise and improve the capacity of lower-skilled clinical providers have taken the form of hub-and-spoke knowledge-sharing models utilizing tele-education and collaborative care management 15, 16. For example, Project ECHO (Extension for Community Health Outcomes) was created to fulfill the health-care needs of patients without access to medical specialists. The project educates and empowers non-specialty generalist clinicians to diagnose and treat complex chronic health conditions, including hepatitis C, HIV/AIDS, chronic pain, addiction and other conditions through remote, technology-enabled collaborative care with specialists 16. Already, Ukraine has witnessed the tangible benefits of similar models in improving diagnosis and treatment of multi-drug-resistant tuberculosis 17. Flexible policies that facilitate OAT access and resource re-allocation through task-shifting of OAT dispensation and supervision, operations-improvement efforts and effective hub-and-spoke knowledge-sharing networks may alleviate financial and human resource constraints on OAT scale-up in both countries. Governments can play powerful roles in reducing stigma and improving the relationship between law enforcement, the judiciary and PWID by encouraging the referral of PWID to treatment instead of detention 18. In the wake of the global financial crisis, safety net funding mechanisms have flattened if not decreased, potentially threatening the significant benefits gained in HIV prevention and treatment 19. Key populations such as PWID are particularly vulnerable to programming cuts. In this environment of economic austerity, countries with synergistic opioid addiction and HIV epidemics must innovate beyond existing resources by borrowing and adapting proven international best practices to safely expand OAT. None.