Assuring safety of preventive chemotherapy interventions for the control of neglected tropical diseases

Overview

This document aims to help programme managers to answer questions like these with particular emphasis on the management of SAE following preventive chemotherapy using one or more of the following medicines: albendazole, mebendazole, azithromycin, diethylcarbamazine, ivermectin, and praziquantel.

An expansion of preventive chemotherapy programmes will lead to more AE, including more ADR, more coincidental AE and, possibly, more operational errors. It will also lead to more SAE, which are of particular concern because they may cause unjustified opposition to preventive chemotherapy. Management of SAE requires effective reporting and investigation. It can lead to the identification and correction of operational errors, and may help to distinguish a coincidental AE from an ADR actually caused by the medicines used. Surveillance of AE is an effective means of monitoring preventive chemotherapy programmes safety and contributes to their credibility. It allows for proper management of SAE and avoids inappropriate responses that can create a sense of crisis.

The purpose of this document is to help managers establish a safety surveillance system. It offers practical advice for establishing national policies and guidelines concerning: preventing AEs and SAEs; the objectives of safety surveillance; reporting, investigating, and responding to SAEs; a communication strategy on preventive chemotherapy safety for the public and the media.