SAE Handbook

This handbook has been designed to provide program managers with a brief, capsular set of steps to follow when required to deal with Serious Adverse Events (SAEs) – often as emergencies – and to serve as an aid to facilitate immediate and appropriate program responses.

The handbook has been created in line with suggestions from the Fifth Meeting of the Working Group on Access to Assured-Quality Essential Medicines for Neglected Tropical Diseases (WGA) WHO, Geneva,Switzerland – 26 April 2013 that resolved to “Further encourage and support countries to adopt and adapt existing tools and guidelines for
safety monitoring in NTD treatment & control activities through effective collaboration between national pharmacovigilance systems and NTD programmes”. Indeed, it is derived largely from the WHO manual “Assuring Safety Of Preventive Chemotherapy Interventions For The Control Of Neglected Tropical Diseases: Practical Advice For National Programme Managers On The Prevention, Detection And Management Of Serious Adverse Events”1 that provides more extensive information on the detection, management, investigation and reporting of AEs and SAEs. Significant portions of the WHO Manual have been incorporated into the present handbook to ensure that standardized definitions and the
recommendations made at the global level (particularly through WHO and global regulatory agencies) are accurately reflected. Additionally, documents produced by WHO for its immunization programs have also been used to develop and highlight key concepts presented in this handbook. A set of companion training materials that can be used by
NTD programs for in-person and remote trainings for both program managers and health workers/community drug distributors is available separately.

The handbook was developed by the RTI-led ENVISION project in collaboration with the Task Force for Global Health, assisted by numerous concerned public health and medical professionals.