On this page you will find links to a wide variety of resources related to safety monitoring and pharmacovigilance with a focus on HIV/AIDS. You will find tools and guidelines, relevant publications and discussion articles, videos, links to external sites and much more.
We are continually updating this page so please check back often! If you have any tools, other resources or items of interest that you believe would be helpful for others and that you would like to share with members, please let us know, either as a blog, in one of the discussion groups, or email a site co-ordinator directly.
WHO
A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines
There is an urgent need to develop robust pharmacovigilance systems for antiretrovirals particularly in resource-limited settings. This detailed manual gives a step by step approach to undertaking the pharmacovigilance of these medicines. Good pharmacovigilance will identify the risks in the shortest possible time after the medicine has been marketed and will help to identify risk factors. This manual describes the principles of both spontaneous reporting systems and cohort event monitoring programmes. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS programmes.
The World Health Organization global database for active toxicity monitoring of antiretroviral (ARV)
The World Health Organization global database for active toxicity monitoring of antiretroviral (ARV) drugs is a collaborative initiative to generate reliable evidence on the safety profile of new ARVs drugs including dolutegravir to address gaps in safety data. It was developed and is managed by the WHO HIV Department and the Special Programme for Research and Training in Tropical Diseases (TDR).
- The World Health Organization global database for active toxicity monitoring of antiretroviral (ARV) homepage
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WHO presentation at workshop on pharmacovigilance and reporting and management of adverse drug reactions associated with ARVs for health care workers Gaborone, Botswana, June 2018
Pharmacovigilance for Antiretrovirals in Resource-Poor Countries
Little is known about the toxicity profile of ARVs in developing countries. These countries have special factors and conditions that are very different from those of the developed world and medicine use and safety may therefore vary considerably. The monitoring of ARVs in these populations is therefore of paramount importance, and methods of monitoring are the subject of this article.
The British Columbia Centre for Excellence in HIV/AIDS (BC-CfE)
Antiretroviral Drug Safety Alerts
The BC Centre for Excellence in HIV/AIDS (BC-CfE) is Canada’s largest HIV/AIDS research, treatment and education facility—nationally and internationally recognized as an innovative world leader in combating HIV/AIDS and related diseases. Here they share Antiretroviral Drug Safety Updates from various sources around the globe.
Articles
Global Pharmacovigilance for Antiretroviral Drugs: Overcoming Contrasting Priorities
With increasing numbers of people worldwide on antiretroviral drugs, the need for improved and sustained global drug safety monitoring or pharmacovigilance is critical. 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 ARVs. Important but contrasting priorities and values among stakeholders—all of whom are dedicated to establishing global pharmacovigilance—were identified as barriers to progress.
The antiretroviral nevirapine is associated with hypersensitivity reactions in 6%–10% of patients, including hepatotoxicity, maculopapular exanthema, Stevens–Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). This study sort to undertake a genome-wide association study (GWAS) to identify genetic predisposing factors for the different clinical phenotypes associated with nevirapine hypersensitivity.