{SPECIAL ARTICLE} PHARMACOVIGILANCE OVERVIEW IN INDONESIA

Even though that the history of pharmacovigilance started in the end 1950s (or early 1960s) after Thalidomide tragedy, the mechanism of pharmacovigilance established after years later. The usage of “Yellow Card scheme” was first developed in England in 1964 as a response for Thalidomide tragedy, to collect necessary information regarding suspected adverse drug reaction (ADR).

In Indonesia the implementation of pharmacovigilance is quite new. The first regulation which implicitly mentioned pharmacovigilance was the Regulation of Ministry of Health No 1010, 2008 regarding drug registration. After that, several regulations regarding Pharmacovigilance implementation were issued.

 

Pharmacovigilance Ecosystem in Indonesia[1]

In Indonesia, the implementation of pharmacovigilance is divided into 4 categories based on the nature of ecosystem in Indonesia which is unique, so that every ecosystem will require different approach. This report will addressed brief explanation about pharmacovigilance implementation for each category.

Pharmacovigilance for Health Care Professional (HCP)

The implementation of Pharmacovigilance for healthcare professional can be done by professionals who serves from the Hospital, community pharmacy (such as pharmacy), Health Care Center, etc. The provision for Health care professional was issued in 2016 by the Ministry of Health.

Pharmacovigilance for Public Health Program (PHP)

The scope of pharmacovigilance for Public Health Program in Indonesia is limited for following diseases: AIDS, Tuberculosis, and Malaria (abbreviated as ATM).

Vaccine safety vigilance

The vaccine safety vigilance is basically to monitor an adverse event following immunization (AEFI). The AEFI surveillance covers treatment, monitoring, reporting, and mitigation of all adverse events after immunization. AEFI surveillance in Indonesia involves institutions from district level, provincial level until national level. The flow of AEFI reporting as follows[4]:

In above flow process, AEFI reporting is defined with orange arrow. If there’s…