Despite being an established practice in the pharmaceutical industry, the question ‘What is Pharmacovigilance?’ remains a frequently asked one among the general public, students, and healthcare professionals, including doctors and nurses, in developing regions. Whether it is to get an overview of PV as a career path, to understand how adverse events are reported, or to report the ADEs, the question is frequently asked. What is Pharmacovigilance? Before delving into the answer, here are a few facts we would like to present.
- As per https://pmc.ncbi.nlm.nih.gov/, Adverse Drug Reactions (ADRs) are responsible for an estimated 197,000 deaths every year in the EU alone.
- As per general sources, compared to major diseases like heart disease and cancer, Adverse Drug Reactions (ADRs) seem to rank among the 4th–6th leading causes of death.
- According to an article in the Pharmaceutical Journal, recent hospital data show that ADR‑related admissions can account for 6–7% of all acute medical admissions. The positive note here is that with proper prescription, close to 40% of these adverse events are considered avoidable.
The above showcased data highlights that without proper monitoring, many medicinal products, even after approval, can lead to severe and fatal (sometimes) conditions. There arises the need for Pharmacovigilance. Patient safety and product efficacy are the two most crucial factors that undergo constant scrutiny even after market entry and ensure a pharma manufacturer’s sustainability in the market. Without robust vigilance on the pharma products released into the market, tens of thousands of preventable deaths and hospital admissions due to medicines would go undetected.
As defined by the World Health Organization (WHO), Pharmacovigilance is the science and system for detecting, assessing, understanding, and preventing adverse effects or any other drug‑related problems. In practice, it means continuously monitoring medicines after approval, collecting real‑world safety data, and acting quickly when new risks appear.
Periodically, manufacturers are required to report the safety and efficacy of their products to health authorities. There is a need for a Pharmacovigilance expert. PV is no longer just a checkbox; it is a strategically driven function that identifies, evaluates, and prevents adverse events. It minimizes risks and accelerates product lifecycle management, thereby protecting brand reputation.
The Impact of Strong Pharmacovigilance
- Identifies safety signals early and prevents many serious Adverse Drug Reactions (ADRs).
- Supports better prescribing decisions and safer use of high‑risk medicines.
- Reduces avoidable hospitalisation expenses and healthcare costs.
- Protects public trust in medicines by showing that risks are actively managed rather than ignored.
We at VigilareBP ensure that compliant Pharmacovigilance procedures are integrated across the product life cycle. From signal detection to ICSR case processing, and aggregate report writing to submissions, our expert team focuses on managing global compliance. We support the development of safe, effective, and trusted medicines and medical products for global markets. Our goal is to promote the safe and effective use of pharmaceutical products and to ensure that patients receive the highest quality of care.