Notification of adverse drug reactions should be made mandatory

Adverse drug reaction (ADR) reporting or pharmacovigilance is an integral part of quality patient care as ADRs not only impair quality of life for the patient, they also increase treatment costs as they increase the likelihood of hospitalization. At times, they may be potentially life-threatening. The World Health Organisation (WHO) has defined pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems”.

A database of ADRs will help the clinician to identify any clinical event occurring as a result of a drug being administered and manage it in time. This was the very objective of the Pharmacovigilance Programme of India (PvPI) i.e. to generate data about ADRs across the country by promoting ADR reporting. PvPI is run by the Indian Pharmacopoeia Commission (IPC) as its National Coordination Centre (NCC) under the aegis of the Health Ministry.

Like all programs, several challenges undermine its effectiveness. Under reporting is one such challenge.

PvPI encourages reporting of all types of suspected adverse reactions with all pharmaceutical products irrespective of whether they are known or unknown, serious or non-serious and frequent or rare.

ADRs should be reported without delay as a contribution to the safety profile of a drug, which is still evolving. If this information is given to the competent authorities, hitherto unknown risks can be identified and tackled.

At IJCP, we receive several case reports describing adverse effects of drugs, which are not mentioned in the PvPI database. In view of this, we propose that no case report linked to a drug side effect should be published or presented in a conference unless it is notified in PvPI. We have adopted this as part of our publishing policy.

The Heart Care Foundation of India (HCFI) has also written to IPC in this regard with the suggestion that notification of ADRs to PvPi should be made mandatory before a case report is published in any journal or is presented at a conference or any clinical meeting.

This will help in strengthening the PvPI program.

Dr KK Aggarwal

Padma Shri Awardee
Vice President CMAAO
Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA