PHARMACOVIGILANCE AND IT’S IMPORTANCE
Introduction
The etymology of the word “pharmacovigilance” is from: Pharmakon (Greek) = medicinal substance, and Vigilia (Latin) = to keep watch.
Pharmacovigilance (PV) is the science and practice related to monitoring the safety of medicines and preventing adverse effects on patients and the public. It is a vital component of drug regulation and contributes to the protection of public health and the rational use of medicines.
Pharmacovigilance involves collecting, analysing, and evaluating data from various sources, such as clinical trials, spontaneous reports, literature, registries, and social media, to detect signals of potential safety issues with medicines. These signals are then assessed for their causality, frequency, severity, and preventability, and appropriate actions are taken to minimize the risks and maximize the benefits of medicines
Pharmacovigilance began to appear about 170 years ago, although it was not yet named as such at that time. In the mid-70s, a group of French pharmacologists and toxicologists proposed the term “Pharmacovigilance” to define the activities promoting “The assessment of the risks of side effects potentially associated with drug treatment”.
It aims to communicate safety information to health professionals, patients, and regulators, and to promote a culture of reporting and learning from adverse drug reactions (ADRs). ADRs are one of the leading causes of morbidity and mortality worldwide, and pharmacovigilance can help to reduce their burden and improve patient outcomes.
Roles of Pharmacovigilance
Identifying Adverse Drug Reactions (ADRs):
One of the most important roles of pharmacovigilance is the identification of adverse drug reactions (ADRs). ADRs are unintended and harmful responses to a drug, which can range from mild to life-threatening. Pharmacovigilance helps in identifying, evaluating, and preventing ADRs. By monitoring the safety of drugs, it can ensure that the benefits of drugs outweigh their risks.
Improving Patient Safety:
Pharmacovigilance also plays a critical role in improving patient safety. By detecting and reporting ADRs, Pharmacovigilance helps in preventing harm to patients. It also helps in identifying potential safety concerns with drugs and taking appropriate measures to minimize the risks associated with their use. This ultimately improves the safety and quality of healthcare for patients.
Enhancing Public Health:
Pharmacovigilance is also important for enhancing public health. By ensuring the safety of drugs, it helps in maintaining public trust in the pharmaceutical industry. It also helps in preventing drug-related health crises, such as the thalidomide disaster in the 1960s, which resulted in severe birth defects in thousands of children. Pharmacovigilance also helps in promoting rational use of drugs, which is critical for reducing healthcare costs and improving patient outcomes.
Regulatory Compliance:
Pharmacovigilance is essential for regulatory compliance in the pharmaceutical industry. Regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require pharmaceutical companies to monitor the safety of their products and report any adverse events. Failure to comply with these requirements can result in fines, product recalls, and damage to the company's reputation.
Continuous Monitoring:
Pharmacovigilance is an ongoing process that involves continual monitoring of the safety of drugs. This is important because new safety concerns can arise even after drugs have been on the market for many years. Pharmacovigilance also helps in identifying potential drug interactions and contraindications, which can help in preventing harmful drug combinations.
Why Pharmacovigilance is Important?
The importance of pharmacovigilance cannot be overstated. Without this practice, drugs could be approved for use without a full understanding of their potential risks and side effects. This could lead to harm to patients and even death in some cases. Pharmacovigilance ensures that drugs are continually monitored for any adverse effects and that appropriate measures are taken to protect patients.
The need for pharmacovigilance is highlighted by the fact that many drugs have been withdrawn from the market due to safety concerns. For example, the drug Vioxx was withdrawn from the market in 2004 after it was found to increase the risk of heart attacks and strokes. This drug had been approved by the US Food and Drug Administration (FDA) in 1999, but it was not until several years later that its potential risks became apparent.
Pharmacovigilance is a global effort, with regulatory agencies around the world working together to ensure drug safety. In the US, the FDA is responsible for monitoring the safety of drugs and taking action when necessary and in the same way The European Medicines Agency (EMA) performs a similar function in Europe and in India it’s Pharmacovigilance Programme of India (PvPI) a government organization.
In addition to regulatory agencies, pharmaceutical companies are also required to conduct pharmacovigilance activities for their products. They are responsible for collecting data on adverse drug reactions and reporting this information to regulatory agencies. They also monitor the safety of their products through clinical trials and post-marketing surveillance.
Safety concerns can arise even after drugs have been on the market for many years. Pharmacovigilance is important that healthcare professionals and patients can report any adverse effects of drugs to regulatory agencies, so that appropriate action can be taken to ensure patient safety.
Recent Trends and Challenges in Pharmacovigilance
Pharmacovigilance is a dynamic and evolving field that requires constant vigilance, collaboration, and adaptation to new challenges and opportunities. Some of the current trends and challenges in pharmacovigilance include:
The increasing complexity and diversity of medicines, such as biologics, biosimilars, generics, herbal products, vaccines, and personalized medicines.
The globalization of the pharmaceutical market and the need for harmonization and coordination of pharmacovigilance activities across regions and countries.
The emergence of new sources of data and methods of analysis, such as big data, artificial intelligence, machine learning, natural language processing, and social media mining.
The growing expectations and involvement of patients and consumers in pharmacovigilance and their empowerment through digital platforms and tools.
The ethical and legal issues related to data privacy, consent, ownership, access, and sharing in pharmacovigilance.
To address these challenges and opportunities, pharmacovigilance requires a multidisciplinary approach that involves various stakeholders, such as regulators, industry, academia, health professionals, patients, media, and civil society. Pharmacovigilance also requires continuous education and training of its practitioners and users to ensure competence and quality.
Conclusion
Pharmacovigilance is a crucial component of drug safety. It ensures that drugs are continually monitored for potential safety concerns and that appropriate measures are taken to protect patients and the public. Without pharmacovigilance, drugs could be approved for use without a full understanding of their potential risks and side effects, leading to harm to patients. It is a shared responsibility that requires cooperation and communication among all stakeholders. By doing so, pharmacovigilance can contribute to the advancement of public health and the improvement of human lives.
References
https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/
https://www.fda.gov/drugs/drug-safety-and-availability/pharmacovigilance-overview
https://www.sciencedirect.com/science/article/pii/B9780128198377000042
https://www.proclinical.com/blogs/2017-8/what-is-pharmacovigilance-and-why-is-it-important
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7050268/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4576445/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132952/
Student Name: Chandana. N
Student ID: 049/0323
Qualification: B. Tech Biotechnology
E-Mail ID: hsr.chandana@gmail.com
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