A Review on Pharmacovigilance

Abstract

Pharmacovigilance is not just about reporting side effects when they happen. It\'s also about carefully studying how medicines work after they are released to the public. Understanding a drug\'s real value and safety often takes years, as more people around the world use it and more data becomes available.Pharmacovigilance used to be a small part of drug regulation, but now it plays a much bigger role. Collecting and studying information about a drug\'s benefits and risks is mainly a scientific task. However, it also involves challenges related to ethics, laws, money, business interests, and how things are managed.To make sure the information is useful and trustworthy, good practices in pharmacovigilance must be followed. This means gathering and using data in the right way, for the right reasons. Pharmacovigilance promotes the safe and appropriate use of medications. Spontaneous reporting of adverse drug reactions (ADRs) is a crucial aspect of pharmacovigilance. However, significant under-reporting of ADRs persists. In developing countries, adverse drug reactions have become a serious concern. Enhancing knowledge of pharmacovigilance could serve as the foundation for strategies aimed at improving reporting rates and reducing the occurrence of ADRs.

Introduction

Medicines have revolutionized disease treatment, but they can cause adverse drug reactions (ADRs)—harmful or unpleasant effects that may occur even when drugs are used correctly. ADRs are common, sometimes serious, and can lead to illness, disability, or death. Pharmacovigilance is the science of detecting, understanding, and preventing these side effects. It ensures that medicines are used safely and helps guide informed treatment decisions.

Recent high-profile drug safety issues, such as the withdrawal of rofecoxib and concerns about rosiglitazone, highlight the importance of ongoing monitoring. Other notable safety updates (2011) involved drugs like dronedarone, PPIs, bisphosphonates, dasatinib, lenalidomide, daptomycin, tigecycline, drotrecogin alfa, nimesulide, topiramate, valproate, and antipsychotics during pregnancy, which were linked to serious side effects or reduced effectiveness.

Pharmacovigilance operates globally through programs like the WHO Programme for International Drug Monitoring, post-marketing surveillance in the US and EU, and collaborative efforts among regulatory agencies. Modern pharmacovigilance includes risk management, monitoring real-world data, quality control of drug ingredients, and evaluation of drug effectiveness, especially for drugs with a narrow therapeutic index or cancer treatments.

Ensuring drug quality is crucial, as low-quality medicines can be unsafe. The FDA has emphasized monitoring the quality of active and inactive ingredients, managing drug shortages, and ensuring bioequivalence for generic and modified-release drugs. The integration of data-driven approaches and international collaboration has improved the ability to detect, prevent, and respond to drug safety issues.

Overall, pharmacovigilance is essential for protecting patients, improving treatment outcomes, and maintaining confidence in medicines.

Conclusion

Adverse drug reactions, especially those that are rare and delayed, are not all known at the time of market approval. They can be identified based on reports from prescribers, as was the case for some of those mentioned here. Doctors and patients can contribute to pharmacovigilance by reporting adverse effects to health authorities, especially those that are serious or unexpected.Approval may sometimes be granted based on limited evidence of effectiveness, as was the case for dronedarone and drotrecogin alfa. In such cases, it is important not to rush and to remain critical, as new does not always mean useful.India’s pharmaceutical industry is now the third largest in the world by volume, 14th by value, and is becoming an important center for clinical trials. With the launch of new medicines, India needs a strong drug safety monitoring system to protect people from possible harm and side effects.Pharmacovigilance is key to managing the growing number and power of modern medicines. However, India’s current pharmacovigilance system still needs improvement. Even though the Central Drugs Standard Control Organization (CDSCO) recently launched a structured drug safety program in line with WHO\'s goals, the system has not yet achieved the desired impact.Still, better awareness and training for doctors and the public, clearer rules for reporting side effects, stronger enforcement, and cooperation among the government, drug companies, healthcare workers, regulators, and patients could help build a more effective pharmacovigilance system in India.

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Copyright

Copyright © 2025 Harshad Awate, Snehal Suresh Pise, Sonal Navnath Dhotre, Prachi Mahendra Bhosale. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.