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A Handbookon the Management and

Reporting of Serious Adverse Events

following Mass Drug Administrationfor Selected Neglected Tropical Diseases

Eric R. Salenga, RPh, MPH

NPO

World Health Organization

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Effective recognition and management of adverse events

following MDA (AEs-f-MDA)whether caused by the

medicines taken, or notshould be an essential component

of preventive chemotherapy program planning and

implementation.

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As preventive chemotherapy programs scale up, more AEs-

f-MDA are almost certain to be reported along with

increases in the number of serious adverse events (SAEs) as

well.

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Proper management of AEs-f-MDA and effective reporting

and investigation of SAEs are essential and will enhance the

credibility of preventive chemotherapy programs.

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It is important to prepare all MDA facilitators as

well as community members to ensure that the

occurrence of adverse events will be minimized aredetected and handled appropriately.

Thus, the need for a readily available, easy-to-use

reference that will provide adequate information onthe detection, management, investigation and

reporting of AEs and SAEs.

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Chapter I. Introduction

Neglected Tropical Diseases

NTDs in the Philippines

Preventive Chemotherapy

Mass Drug Administration

Adverse Events

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Chapter II. MDA

Pre implementation of MDA

Implementation of MDA

Post-implementation of MDA

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Chapter III. Communication Skills

Essentials of Communication

Identifying stakeholders

How are messages accepted by the audience during AEs

Crisis Communication Lifecycle

Strategies for Presenting Information

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Train regional healthcare workers to identify adverse events

Establish relationships with shareholders and media

Constitute a Safety Surveillance Team (SST)

Primary objective of early detection and response and monitoring

and recording of adverse drug reactions

1. Quick response medical team

2. Active Surveillance Team

3. Crisis Management Team

4. Joint Information Cener