Pharmacist role in Pharmacovigilance

Pharmacovigilance or Drug safety or Patient safety is relatively a lesser known area of medical sciences that has not been fully accessed and utilized by the public and hence there is a need for public education on Safety aspects of medicine. I would want to make a small contribution to upholding patient safety for a healthy society by sharing some of the events encountered.

It was during the small talks that I had with the village people in my native that I came to know the concept of “fear of Medicine”, they have. Even today, there is a stigma amongst the people of villages, small towns and even many metropolitan cities that medicine (drug) causes side effects. The misconception and misinterpretations regarding side effects of the medicines are relevant and are debatable, even today.


Antibiotics and antidiabetic drugs are one of the widely consumed medicines from last decade. An aunt of me was speculative of consuming amoxicillin, dreading the possible side effect of Diabetes and asked me about it after pondering for a very long time. I assured her that most antibiotics do not cause diabetes and in most cases, chronic use of steroids could cause diabetes amongst all the common drugs used by her.

It is observed that people often discontinue the treatment without consulting the treating Physician out of fright about side effects. In most cases, with stigma comes the generalization. The public often generalizes and extrapolate information and end up imagining and creating false information.

The need of this hour is expert advice from various sources such as Industry, institution and practitioners. Queries need to be approached with caution and verified.

“Medicines do cause the side effects but the frequency and seriousness may vary, some occur in susceptible individuals, and many people might not even experience any side effects.”

Pharmacovigilance is the pharmacological science relating to the collection, detection, assessment, monitoring and prevention of adverse effects associated with the use of pharmaceutical products.

Pharmacovigilance activities across the ensure appropriate collection of side effects and evaluate every medicinal product for its benefit-risk ratio. It should be noted that many countries are investing a lot of money and resources to ensure the safety of their residents and regulatory bodies are doing a commendable job in enforcing safety and standards to protect the consumers. The public should be made aware of these and also they should participate spontaneously in such activities to strengthen their efforts.

Pharmacists are healthcare professionals with deep insight on medicinal products, its composition, mechanism of action and possible side effects. Community pharmacist as the name implies, are those who are involved directly with the public, advising them of posology, liaising with Physicians to provide accurate prescription and ensuring medicines are safe and effective. Clinical Pharmacists plays a vital role in Hospitals. They assist the Physicians to prescribe correct medicine and dosage at appropriate schedules.

Pharmacists should be aware of common and frequent side effects, their possible consequences and causal relation with medicine, food and other confounding factors. Additionally, pharmacists should make active efforts in reporting the side effects to an appropriate site so that such reports can contribute profoundly to patient safety. Pharmacists should be well prepared in assisting patients to manage side effects.

Medication non-compliance, also known as medical adherence especially for chronic disease is less than 50%. Since treatment non-compliance often results in secondary side effects, patients need to be counselled and prepared for drug therapy. Hence pharmacist plays an important role in patient counselling.


Pharmacovigilance is evidently progressed in the western world and India is taking huge steps to match with global advances. After the launch of the Pharmacovigilance Programme of India in 2010, Indian pharmacovigilance has made commendable progress and is taking rigorous steps in becoming a true pharmacovigilant state. We are lacking in quantity of adverse event reports. In light of this revelation, pharmacists can make tenable and sterling contribution in educating the public, healthcare professionals and the patients regarding drug safety and patient safety and bring awareness regarding pharmacovigilance in India and need of their participation in the programme.

A Pharmacovigilance process provides safety data regarding the medicinal product, which can be used for safe use of medicines. Hence pharmacist plays an important role in Pharmacovigilance.

Author: Dr. Mathew James, PharmD, Pharmacovigilance professional.