A practical handbook on the pharmacovigilance of antimalarial medicines- 2007 (WHO)

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 relevant factors and conditions include the existence of comorbid conditions such as tuberculosis (TB), malaria and other infections; malnutrition; heavy reliance on traditional and/or alternative therapies; insufficient numbers of trained doctors and pharmacists; abuse of prescription-only medicines; and the likelihood of medicine interactions. In addition, the local systems for the delivery of health care will rely on people who may not have the necessary training, knowledge or expertise, and medicine regulatory systems are either nonexistent or are not adequately equipped to deal with medicine safety issues.

The monitoring of ARVs in these populations is therefore of paramount importance, and methods of monitoring are the subject of this article. This document should be considered in conjunction with a detailed assessment of the WHO publication, The safety of medicines in public health programmes: pharmacovigilance an essential tool, which includes much information that is not repeated here.