Programme managers may be asked questions like these:
- Have you effectively sought and found information on possible adverse drug reaction (ADR) that might occur during the intervention?
- What measures have you put in place to manage adverse events (AE) during the intervention?
- Have you prepared your staff for serious adverse events (SAE) before the start of the intervention?
- Is an effective training cascade in place from national to community level to cope with all levels of AE?
- How will target communities be informed that there is always a small health risk as well as a big health benefit with the use of medicines?
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.
This document is organized in three parts:
- Adverse events and serious adverse events: section 2;
- Management of serious adverse events: sections 3 to 6;
- Establishing a safety surveillance system: sections 7 and 8.