antiretrovirals

With increasing numbers of people worldwide on antiretroviral drugs, the need for improved and sustained global drug safety monitoring or pharmacovigilance is critical. Pharmacovigilance includes monitoring for substandard products, diversion, inappropriate use, and toxicity and is an essential component of safe and effective drug usage. The Forum for Collaborative HIV Research was asked to use its neutral setting for key stakeholders from the UN and government agencies, donors, industry, academia, multilateral organizations, and implementers to discuss the creation of a sustainable global pharmacovigilance system for antiretrovirals (ARVs). Important but contrasting priorities and values among stakeholders—all of whom are dedicated to establishing global pharmacovigilance—were identified as barriers to progress. Recognition, understanding, and respect for these contrasts is a pathway for increased collaboration and cooperation that will then lead to a sustainable system involving all stakeholders including industry and experienced regulatory agencies.

Since 2004 public provision of ARVs in the Dominican Republic has been funded, by the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM). Until 2009 there was a gross correspondence between the increase in the number of treated cases and the funding. From 2009 to 2012, however, the number of cases grew at an average rate of 33.4% (2,958 cases) per year, whereas funding experienced an average decrease of 21.7% (965,382 USD) per year. In 2012, the Ministry of Health (MoH) carried out the first national quantification exercise for the 2013 procurement of medicines, under a standard forecasting methodology.

In 2010, the Ministry of Health (MoH) asked USAID for technical assistance to implement interventions to improve the HIV/AIDS supply chain system. Assessments revealed that fragmentation of the pharmaceutical system contributed to stock-outs and expiration of antiretroviral (ARVs) and other medicines and supplies used by disease control programs. The implementation of an integrated system was proposed as the most efficient and sustainable alternative to confront the HIV/AIDS pharmaceutical supply problems.

Key strategies of the main antiretroviral (ARV) procurement program for PEPFAR to reduce supply chain risks include: (1) employing pooled procurement to reduce procurement and shipping costs and to accommodate changing country needs by making stock adjustments at the regional level, and (2) establishing regional distribution centers to facilitate faster turnaround of orders within defined catchment areas.

In 2004, Malawi began scaling up its national antiretroviral therapy (ART) program. Because of limited treatment options, population-level surveillance of acquired human immunodeficiency virus drug resistance (HIVDR) is critical to ensuring long-term treatment success. The World Health Organization target for clinic-level HIVDR prevention at 12 months after ART initiation is ≥70%.

Purpose of review: This review focuses on current status, progress, challenges and opportunities in global pharmacovigilance for HIV/AIDS treatment.

Background: High quality program data is critical for managing, monitoring, and evaluating national HIV treatment programs. By 2009, the Malawi Ministry of Health had initiated more than 270,000 patients on HIV treatment at 377 sites.

The national scale up of antiretroviral therapy in Malawi is based on a public health approach, with principles and practices borrowed from the successful World Health Organization "DOTS" tuberculosis control framework.

Background: Mortality and morbidity among HIV-exposed children are thought to be high in Malawi. We sought to determine mortality and health outcomes of HIV-exposed and unexposed infants within a PMTCT program.

Rationale, aims, and objectives: For a successful patient outcome, a high level of adherence to antiretroviral therapy (ART) is needed. A 2008 report in Tanzania indicated poor clinic attendance and a high lost to follow-up rate as major threats to optimal ART program effectiveness.

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