PHARMACOVIGILANCE IN INDIA: PAST, PRESENT, AND FUTURE PERSPECTIVE

Its start a decade ago, pharmacovigilance (PV) experienced tremendous development. There have been significant attempts in recent years to transform the current pharmacovigilance systems to meet future expectations. Adverse drug reactions (ADRs) are increasing in frequency, severity, and complexity as novel medication therapies are coming to market more quickly as a result of better laws and regulations. India is the second most popular nation in the world, with around 1 billion active and prospective consumers of pharmaceuticals. Despite being a member of the Uppsala Monitoring Centre, our nation has almost little commitment to the database. This problem is brought on by the inadequate ADR (adverse drug reaction) monitoring system and lack of knowledge among pharmacy associates and medical professionals. The primary objectives of the PV program are patient care, patient safety, and monitoring of negative medication reactions. There is a need for additional clinical preliminary exams and clinical assessments in India to accurately practice PV. A fully functional PV system is essential for the safe and responsible administration of medicines. This review gives a systematic review of pharmacovigilance in India from its origin to its current scenario and also discusses the various strategies and proposals to build, maintain and implement a robust pharmacovigilance system for India in coming years.

A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India

Background: In terms of morbidity and death, adverse drug reactions (ADR) have been highlighted as a worldwide burden. Determining the origin of ADRs remains a tough issue and no one approach for determining causation has been adopted as the gold standard throughout the world. Aim and Objectives: The objectives of the present study were (1) to evaluate the causality of ADRs using World Health Organization-Uppsala Monitoring Center (WHO-UMC) and Naranjo Algorithm ADRs causality assessment tools and (2) to evaluate the agreement and correlation between two universally used approaches for causality assessment of ADRs viz. WHO-UMC system and Naranjo algorithm. The secondary objective was to assess the reported ADRs in a tertiary care hospital in Northern India. Materials and Methods: The present study was a retrospective cross-sectional study. A total of 180 patients of ADRs from different departments of tertiary care hospital which were reported by Pharmacovigilance unit over a period of April 2018 to May 2019 were assessed. The causality assessment for these reported ADRs were done by WHO-UMC system and Naranjo algorithm. The agreement between these two methods calculated by Cohen’s kappa (?) statistics and Spearman’s correlation was used to evaluate the correlation between these two methods. Results: According to WHO-UMC criteria, 55.5% of adverse event instances were of the probable type, 34.4% were possible, 9.4% of cases were improbable, and 0.5% of cases were definite. According to the Naranjo methodology, 80.5% of adverse outcomes were likely, while 19.4% were feasible. The WHO and Naranjo causality comparisons had a positive and fair agreement (= 0.29), according to Cohen’s kappa test. Between the WHO-UMC scale and the Naranjo algorithm, the Spearman’s correlation coefficient was determined to be 0.409. Conclusion: “Probable” was the most common causality category observed by the WHO-UMC scale and the Naranjo algorithm. The WHO-UMC scale and the Naranjo algorithm have a good and reasonable agreement.

Enlightenment of international pharmacovigilance system on establishment of pharmacovigilance system of Chinese medicine / 中国中药杂志

Pharmacovigilance system is an extension of the original adverse drug reactions monitoring and reporting system as well as an internationally recognized basic system that must be matched with the whole life cycle supervision of drugs. European Union(EU)pharmacovigilance system, World Health Orgnization(WHO) Uppsala Monitoring Center system and ICH system are internationally recognized pharmacovigilance systems. They all have their own pharmacovigilance characteristics and could provide guarantee for clinical safe drug use. With the deepening of international communication, pharmacovigilance has also been developed in China. Pharmacovigilance of Chinese medicine is a new concept based on the existing pharmacovigilance system of chemical medicine and the characteristics of Chinese medicine. In ancient China, Chinese medicine also had its own ways of early warning. Ancient medical books have records on the toxicity classification, clinical pharmacovigilance and intoxication rescue of Chinese medicine. With the increase of public recognition of Chinese medicine in recent years, especially since the government issued the 13 th Five-Year Plan for the development of Chinese medicine, the pharmaceutical industry in China has paid more and more attention to the pharmacovigilance of Chinese medicine.However, the pharmacovigilance system of Chinese medicine has not yet been established, and it still needs to be explored and improved.Therefore, it is very necessary to develop the system to standardize pharmacovigilance-related activities of Chinese medicine. In this context, this study analyzed and learned the characteristics of pharmacovigilance systems of EU, ICH, and WHO Uppsala Monitoring Center, so as to provide some enlightenment for the establishment and improvement of pharmacovigilance system of Chinese medicine.