Reaching out to patients - key to success of pharmacovigilance!

The recent incident, termed as chloroquine disaster, has caused death of a child and more than 50 hospitalizations following the mass administration of chloroquine tablets in a village of Polavaram district of Andhra Pradesh. 

Chloroquine tablets were given as a prophylaxis measure as the malaria cases surged. While the issue is under investigation, one thing is made clear, medicine may cause harm to the user. 

Medicines’ harmful effects are recognized in many instances but the thalidomide disaster of 1960s has given the new direction leading to worldwide initiative of monitoring adverse effects of medicines. This is the beginning of Pharmacovigilance Programme.

This year (2026) the country is celebrating National Pharmacovigilance Week (NPW) during 17th to 23rd September 2026. This is the 6th national celebration with first observed during 2021. The themes of previous five NPW are:

First NPW (2021) – Pharmacovigilance: A Step Towards Patient Safety; Second   NPW (2022) – Encouraging Adverse Drug Reaction reporting by patients; Third NPW (2023) – Empowering Healthcare with Pharmacovigilance; Fourth NPW (2024) – Building ADR Reporting Culture for Patient Safety; Fifth NPW (2025) – Your Safety, just a click away: Report to PvPI.  

The 6th NPW intends to have a nationwide celebration with a theme “Promoting Rational Use of Medicines through Pharmacovigilance: A Step Towards Safer Healthcare”. The aim of the celebration is to create awareness about reporting adverse events that experienced with the use of medical products. The main function is scheduled on 21st September 2026 at Dr. Ambedkar International Centre, New Delhi. It is expected to have a big gathering of pharmacovigilance professionals, scientists, drug regulators/policy makers, research scholars, academicians and students.  The function intends to deliberate on the following areas: Patient perspective in pharmacovigilance, Pharmacovigilance of vaccines, Materiovigilance, Public Private Partnership in Pharmacovigilance, and Regulatory Perspective of Pharmacovigilance. This high-profile meeting has mandatory registration for attending the function: registration fees prescribed is ? 1180/- for industry professionals and health professionals; ? 590/- for students, faculty members and research scholars. The National Coordination Centre of Pharmacovigilance Programme of India plans to release its important publication ‘7th Edition of National Formulary of India (NFI)’, a publication intends to promote rational use of medicines. Both NPW 2026 and NFI aligned with the theme of promoting rational use of medicines. 

It would be interesting to narrate little bit of historical background of genesis of pharmacovigilance and India’s participation. The word ‘Pharmacovigilance’ is derived from the Greek word pharmakon meaning drug and the Latin word vigilare meaning to keep awake or alert, to keep watch. Though medicines are approved after thorough screening and clinical trials, all adverse effects are not known prior to approval. The term was initially used in France during 1960s and the World Health Organization (WHO) introduced in 2002. The thalidomide disaster occurred in 1961 raised international concern on unsafe medications. The drug was recognised as one of the safest and widely used throughout the globe except United States of America. It was promoted as sleeping tablet as an alternative to barbiturate. The drug had better safety profile citing over dosing 100 times the normal dose was not lethal. The drug was projected to be future tranquiliser. The issue of thalidomide, causing birth of deformed babies, was known after sometime only in 1961 though drug was introduced in 1957. More than 10,000 babies of twenty countries were the victim of thalidomide. Great human tragedy! The America escaped just because of not permitting its use despite tremendous pressure. The country had realised the tough action of FDA officer of not allowing thalidomide in America and felicitated her with highest honour of USA, President’s Gold Medal.  Many initiatives were taken worldwide to promote safety of medicines. However, most of these activities like MedWatch of USA and Yellow Card of United Kingdom were restricted to mostly high-income countries. After a pilot study in USA, an international database was established at Geneva, WHO head quarter, in 1971.  The global data base on adverse effects was moved to Uppsala, Sweden, in 1978. Since then, Uppsala Monitoring Centre (UMC) has been managing the primary aspects of expanding worldwide Pharmacovigilance network of more than 180 countries covering approximately 99 per cent of the world's population. India joined the WHO programme in 1998. The country too launched its own programme at different time and the current programme known as ‘Pharmacovigilance Programme of India’ with Indian Pharmacopeia Commission as the National Coordination Centre (NCC). The database in India is maintained by the NCC and it initiates the celebration of NPW as part of popularising the pharmacovigilance activities in the interest of patient safety. 

There are many issues like there is no universal restriction on use of medicines. The medicine is withdrawn or banned in some countries and but available for use in other countries. The withdrawal or banning of medicines begin with generation of data emphasizing the need of such action. This is possible if we have a robust National Pharmacovigilance programme. WHO has been urging the countries to put the mechanism in place to enhance patient awareness and knowledge about the medicines and medication use process, including patients’ roles in managing their own medications safely. Essential tools and technologies should be in place for use by the medicine users to achieve medicine use without harm. It has designed the third WHO global patient safety challenge: Medication Without Harm.  The WHO has developed public awareness and medication awareness tool: KNOW, CHECK and ASK. The first point is to educate and sensitize patients so that they would be interested to know about their medicines; Check the medicines are as per the prescription (usually at the dispensing point); Ask the patients whether they understand the instruction given to them on medications. Empowering and engaging the patients is perhaps the most important component of patient education. 

The Pharmacovigilance has many stakeholders: drugs controlling authority including laboratories ensuring qualities, medicine manufacturers, medicine distributors, and healthcare providing professionals. The real victim of adverse effects of medicines is the patients who use the medicines. There are many instances where people have died because of medicine consumption. Are we really concerned about the patient real sufferers of adverse effects of medicine? While it is impractical to avoid all adverse effects but a vigilant patient probably be able to reduce the medicine related harms. India’s Pharmacovigilance Programme has achieved many milestones but can be further strengthened by promoting patient education on medicine use. Observance of the National Pharmacovigilance Week is perhaps a tool to promote patient education on medicine use. It reminds us a filmy dialogue “Don’t under estimate the power of a common man”! Improvement in medicine use literacy would definitely strengthen Pharmacovigilance Programme of India. Patient engagement and empowerment is perhaps the most powerful tool to improve patient safety. There is need of developing mechanisms to engage patients and promote pharmacovigilance activities to promote patient safety.