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Research Paper | Pharmaceutical Science | India | Volume 8 Issue 5, May 2019
Adverse Drug Reaction Reporting System in Pharmacovigilance
Abstract: Pharmacovigilance is the process of the collection, detection, analysis, monitoring and prevention of various ADRs (adverse drug reactions) or AEs (adverse events) and any drug related issues and problems. After the thalidomide tragedy (1961) health professionals, doctors, nurses, clinicians, dentists, pharmacists, WHO (World Health organization) started International Drug Monitoring Program (1968) with the collaboration of WHO collaborating centre UMC (Uppsala Monitoring centre) to protect public health and safe use of the medicinal products and improving public health to decrease ADRs (adverse drug reactions) occurs from the interventions or pharmaceutical products. Pharmacovigilance aim is to care and safety of patient in relation to the medicinal use. The purpose of pharmacovigilance is to secure early detection. In 2010, there are 134 countries were the members of the WHO (World Health Organization) for International Drug Monitoring program. WHO establish various pharmacovigilance centers for the reporting of ADRs. The hospitals and pharmaceutical industries can reports ADRS (adverse drug reactions) to regional pharmacovigilance center or directly to the drug regulatory authority like USFDA (United States Food and DRUG Administration) in America, EMA (European Medicine Agency) in Europe, MHLW (Ministry of Health and Labour Welfare) in Japan, CDSCO (Central Drugs standard Control Organization) in India. The suspected unexpected serious adverse reactions can be reported within 7 calendar days and ADRs can be reported in 15-30 calendar days. The adverse drug reaction can also reported online.
Keywords: Pharmacovigilance, ADRs, WHO, USFDA
Edition: Volume 8 Issue 5, May 2019,
Pages: 1730 - 1731