Pharmacovigilance

According to the World Health Organization (WHO), Pharmacovigilance is the science and activity associated with detecting, evaluating, realizing and preventing adverse drug reactions or any other drug related problem.1

Purpose of pharmacovigilance is to ensure patient's safety, by being careful about drug use and identifying new or potential adverse reaction to any medication.

The Adverse Drug Reaction (ADR) is the unexpected reaction that takes place in the human body either due to the use of drug or drug like substance2. This may happen even if someone has taken the medicine in indicated dose or used the medicine properly. If this occurs, one must report Adverse Drug Reaction (ADR).

An adverse event is any event associated with the use of a drug or drug like substance, which has nothing to do with the treatment of the disease. 

Usually poor quality of medicine, inadequate or excessive use of medicine which causes adverse reactions in the human body; all are included in Adverse Drug Event (ADE)

In 1957, after the first marketing of Thalidomide, it was used for many indications, even in pregnancy. In 1960, due to the use of Thalidomide, more than ten thousands malformed babies were born in 46 countries. Consequently Thalidomide was banned to save more lives from such adverse events3.

Imagine, if it was not banned, our own family members could have suffered from a birth defect. Considering the catastrophe of Thalidomide, WHO launched the international drug monitoring program in 1961.

Since 1978, the World Health Organization (WHO) has established the Pharmacovigilance Network in more than 150 countries, known as The WHO Programme for International Drug Monitoring through the Uppsala Monitoring Center (UMC)4.

To assist in the implementation of the Pharmacovigilance Program in Bangladesh, WHO granted full membership of the International Drug Monitoring Program to DGDA ( Directoreate General of Drug Administration) in 20145.

The National Pharmacovigilance Program officially began in Bangladesh during September 2013, by the Directorate General of Drug Administration (DGDA) in collaboration with SIPS  Program6.

In fact, DGDA started the Adverse Drug Reaction Monitoring (ADRM) cell in 1996 under the direction of WHO7.

Currently, healthcare providers and Pharmacists can report Adverse Drug Event (ADE) directly orto the Directorate General of Drug Administration.

To report an ADR, you need at least four data called as PREP,  which stands for Patient, Reporter, Event, Product8.

Roche Bangladesh with its local safety unit is there beside you 24 hours if you want to report an ADR. Anyone taking Roche medicines, they or their family member can report any Adverse Drug Reaction by a call or an e-mail.

You can also contact your doctor immediately about any problem regarding the medicine, as well as report to the pharmaceutical company's special helpline (if any) or to their representative.

We all should be aware about pharmacovigilance because each life is precious, and we don't want to lose it out of negligence.