Millions of patients are dying globally every year due to Adverse Drug Reactions

Bruce Pomeranz and colleagues at the University of Toronto estimate that ADRs could account for?more than 100 000?deaths in the USA each year, making them the fourth commonest cause of death after heart disease (nearly 750000 deaths), cancer (530000), and stroke (150000) (JAMA 1998; 279: 1200–05). Furthermore, the estimated?197,000 annual deaths?resulting from ADRs in Europe is an extrapolation of a meta-analysis of studies performed in US hospitals. In 2002 in England there were a total of 3.8 million acute admissions,?suggesting that ADRs causing hospital admission are responsible for the death of?5700 patients (3800 to 7600) every year. There is no data available for 90% population of the world because they have not adopted drug safety system and not ready to adopt many more years until punish them to implement immediately.

Adverse drug reactions (ADRs) are estimated to be between the fourth and sixth most common cause of death worldwide. ADRs are estimated to be the fourth leading cause of death in the United States—ahead of pulmonary disease (before the COVID-19 pandemic), diabetes, AIDS, pneumonia, accidents, and automobile deaths.

Implementing Good Pharmacovigilance Practices (GVP) helps ensure patient safety and improves the overall understanding of drug effects in the real world. Good pharmacovigilance practices involve systematic monitoring and assessment of the safety of pharmaceutical products. Here are some key principles:

1.????? Data Collection: Gather comprehensive data on adverse drug reactions (ADRs) from multiple sources, including clinical trials, post-marketing surveillance, and spontaneous reports.

2.????? Signal Detection: Use statistical methods to identify potential safety signals from collected data that may indicate new or increased risks associated with a drug.

3.????? Risk Assessment: Evaluate the significance of identified signals by analyzing the strength, consistency, and causality of the evidence.

4.????? Risk Management: Develop strategies to minimize risks, such as updating labelling, issuing warnings, or implementing risk communication plans.

5.????? Regulatory Compliance: Adhere to guidelines set by regulatory authorities (e.g., FDA, EMA) for reporting and monitoring safety data.

6.????? Transparency: Maintain open communication with healthcare professionals, patients, and the public regarding drug safety issues.

7.????? Continuous Education: Provide ongoing training for healthcare professionals on recognizing and reporting ADRs.

8.????? Collaborative Efforts: Work with various stakeholders, including regulatory bodies, healthcare providers, and patients, to enhance pharmacovigilance efforts.

There are now 180 countries are members of global drug monitoring committee. Millions of people are dying every year due to adverse reactions globally but there is no system in place on every country to monitor exact death.

Among the 23 million ADRs recorded in VigiBase (the World Health Organization pharmacovigilance database), 3 250 967 were included with?43 685 fatal. They were reported mainly in patients older than 75 years. The 3 most frequently involved drug classes were antineoplastic/immunomodulating drugs followed by nervous system and cardiac drugs.

GMP inspection is mandatory every country of the world. Similarly GVP inspection is now also become mandatory by USA, Europe, GCC, Japan, South Korea, Russia, Kazakhstan and India. Developing countries are demanding now just basic documents of pharmacovigilance such as PSMF, PSUR and RMP in registering CTD dossier and re-registration. Pharmacovigilance establishment means establishment of drug safety database to take care individual case study report. Exact ADRs estimate is possible when GVP will be implemented globally. Millions of innocent patients are dying globally due to lack of drug safety establishment. It is time to make drug safety establishment mandatory without delay in every country of the world. GMP and GVP go hand in hand. GMP only ensures quality of medicine and GVP ensures drug safety. Good Pharmacovigilance Practices is need of the hour. You can get free consultation via [email protected] or by WhatsApp +91-9818131498.