Cited from the definition by World Health Organization (WHO), pharmacovigilance in defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible medicine related problems.
Based on Decree of Ministry of Health No. 1799/MENKES/PER/XII/2010 regarding Pharmaceutical Industry, it has been mentioned that Pharmaceutical Industry has an obligation to conduct Pharmacovigilance. Then, the implementation of pharmacovigilance in pharmaceutical industry is regulated in the Decree of Head of Indonesia FDA (BPOM) No. HK.03.1.23.12.11.10690 year 2011.
To improve public health and safety in relation with the drug use, as well as to contribute for assessment of the benefits, harms, effectiveness and risks of the drugs we have marketed, Mitsubishi Tanabe Pharma Indonesia (MTID) has established pharmacovigilance section responsible for pharmacovigilance system in MTID. In 2012, the pharmacovigilance system in MTID had the opportunity to become the only Japanese company to participate in pharmacovigilance piloting project organized by BPOM.
Pharmacovigilance activities in MTID as stated in the written document are as follows :
By monitoring the safety aspects of drug that has been marketed through pharmacovigilance activities, pharmacovigilance in MTID also conducts interesting activities that can increase pharmacovigilance awareness, such as creating PV Card, PV Video, PV Bulletin, and others. It is expected that these things could detect many side effects, both previously known and newly appeared.
If you receive a report regarding drug side effects or other drug related problems, you could report it to the MTID’s pharmacovigilance section through menu Contact Us.