What Students Need To Know About History of Pharmacovigilance

Summary

Dr. Pramat Khatri from British Biomedicine Clinical Trials discusses pharmacovigilance, a critical component of patient safety. He defines it as the science of monitoring, assessing, and preventing adverse drug reactions. The talk covers India's pharmacovigilance history, the importance of patient care and public health, and the role of regulatory bodies. It also touches on the significance of reporting mechanisms like the UMC and the PVPI, and the classification of adverse drug reactions. The presentation concludes with a call for a collaborative approach involving various stakeholders for effective pharmacovigilance.

Takeaways

• 💊 The core patient expectations at hospitals are to ensure safety, expedite recovery, and receive respectful treatment.
• 🚨 Pharmacovigilance is crucial for monitoring and preventing harm from medications, with the understanding that dying from a disease is sometimes unavoidable, but not from medicine.
• 🔍 The term 'pharmacovigilance' is derived from 'pharma' meaning medicine and 'vigilance' meaning a close watch, signifying the need for alertness regarding drug-related risks.
• 📈 Pharmacovigilance encompasses the detection, assessment, understanding, reporting, and prevention of adverse drug events or side effects.
• 🏥 The primary goal of pharmacovigilance in patient care is to enhance medication safety and public health, while also contributing to the risk-benefit assessment of medicines.
• 📊 In India, the history of pharmacovigilance includes the establishment of regional ADR monitoring centers, WHO ADR monitoring programs, and the launch of the Pharmacovigilance Program of India (PvPI).
• ⛔ Several drugs have been banned by the Indian FDA due to severe adverse reactions, highlighting the importance of ongoing pharmacovigilance.
• 🌍 Globally, adverse drug reactions are a significant cause of mortality, with the UK reporting 50,000 to 70,000 deaths annually, and the USA ranking such reactions as a leading cause of death.
• 🌐 Data from pharmacovigilance is collected from various sources, including regional centers and external organizations, and is submitted to regulatory authorities and databases.
• 📝 The script provides an example of how to report adverse drug reactions to the Uppsala Monitoring Centre (UMC), emphasizing the importance of detailed and accurate reporting.

Q & A

What is the primary goal of pharmacovigilance?

The primary goal of pharmacovigilance is to ensure patient safety and improve healthcare by monitoring, assessing, understanding, and preventing adverse drug reactions or any other drug-related problems.

Why is pharmacovigilance critical in healthcare?

Pharmacovigilance is critical because it helps to prevent deaths caused by medicine, which is unacceptable, and ensures that the benefits of a medicine outweigh its risks.

What does the term 'pharmacovigilance' mean?

Pharmacovigilance is derived from 'pharmaco' meaning medicine and 'vigilance' meaning a close watch or alert watchfulness. It refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

How does pharmacovigilance contribute to public health?

Pharmacovigilance contributes to public health by improving the safety profile of medicines, informing regulatory decisions, and enhancing the understanding of the benefits and risks of medicines among health professionals and the public.

What is the history of pharmacovigilance in India?

In India, pharmacovigilance started with 12 regional centers for ADR monitoring from 1982 to 1989. In 1997, three centers joined the WHO ADR monitoring program. The National Pharmacovigilance Program was established in 2004 to 2008, and the Pharmacovigilance Program of India (PvPI) was launched in 2010.

What is the role of the UMC ( Uppsala Monitoring Centre) in pharmacovigilance?

The UMC provides a software platform where clinical data or adverse drug reactions can be collected and submitted. It offers various tools for report handling, search, statistics, and drug interaction overview.

How can adverse drug reactions be classified based on their onset?

Adverse drug reactions can be classified as acute if symptoms occur within 60 minutes of infusion, subacute if symptoms appear after 1 to 24 hours, and latent if symptoms emerge after two days.

What are the two types of adverse drug reactions according to the FDA?

According to the FDA, adverse drug reactions can be classified into Type A, which are dose-dependent and predictable, and Type B, which are idiosyncratic or immunologically mediated and are rare and unpredictable.

What is the significance of pharmacovigilance in the context of drug regulation?

Pharmacovigilance is significant in drug regulation as it provides data that can lead to the banning or withdrawal of unsafe drugs from the market, ensuring public safety.

How can the severity of adverse drug reactions be classified?

The severity of adverse drug reactions can be classified as mild, moderate, or severe. Mild reactions require no change in therapy, moderate reactions may require additional treatment or hospitalization, and severe reactions can be life-threatening or cause permanent defects.