Mitsubishi Chemical Group

Pharmacovigilance

Figure 1. Pharmacovigilance team delivered training to MTID staffs

Pharmacovigilance

Did you know what Pharmacovigilance is?

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 :

  1. Handling of pharmacovigilance reports
    1. Spontaneous Reporting
    2. Periodic Safety Update Reporting
    3. Literature Reporting
    4. Reporting of Actions Taken by Regulatory Authorities of Other Countries
    5. Reporting of Actions Taken by Marketing Authorization Holders in Other Countries
    6. Reporting of Special Situation
    7. Adverse Event and Product Quality Complaints (AEPQC) Reports
Figure 2. Pharmacovigilance team conducted self checking
  1. Controlled well and valid Pharmacovigilance documentation system.
  2. Sustainable pharmacovigilance training to pharmacovigilance personnel, all MTID staffs and MTID’s business partner. Pharmacovigilance team in MTID also actively participated together with BPOM, pharmacovigilance organization and with external organization in the execution of external training.
  3. Pharmacovigilance Audit and Self-checking is conducted periodic and standardized to ensure the compliance of Pharmacovigilance activities implementation in MTID.
  4. A risk management system designed to identify, characterize, prevent or minimize risks for MTID’s products.
  5. Safety review committee to discuss issues that can impact the Package Insert of MTID’s products.
  6. Pharmacovigilance Agreement developed with partners to be the basic legal for the pharmacovigilance performance obligation.
  7. Pharmacovigilance Management Review to review the pharmacovigilance implementation in MTID in a year.
  8. Pharmacovigilance business continuity plan is prepared to anticipate incident or disaster that have impact to pharmacovigilance activity in MTID (Business Continuity Plan).

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.