ABOUT AUTHOR:
Vishwa Deepak kumar
Departement of Pharmacy,
IEC group of institution,
Greater Noida (U.P), Pin- 201301
vdkumar.iec@gmail.com
ABSTRACT:
Pharmacovigilance is an important and integral part of clinical research. Pharmacovigilance is “defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term adverse effects of medicines. This addresses what exactly is Pharmacovigilance? What do we know of its benefits and risks, challenges and the future hold for pharmacovigilance in Indian medicine. Here the main focus on the aims and role of Pharmacovigilance in medicines regulation and their Partners. This article describes and discusses the National programme of pharmacovigilance and centre in India. There role in collecting the reports ADRs of medicines. Further effectiveness and risk assessments of therapies are been discussed. The important role played by health care professional, pharmaceutical industries, media, and programmes carried by WHO. Finally the conclusion describes the major challenges and achievements for the future pharmacovigilance programmeand toxicity is not socritical if botanicals are used in traditional forms (Harborne., 1998).
REFERENCE ID: PHARMATUTOR-ART-1796
INTRODUCTION:
What is Pharmacovigilance?
Pharmacovigilance (PV or PVG) is the science associated with detection, assessment, understanding and prevention of adverse effects of drugs. According to the Pharmacovigilence definition given by WHO, it is "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. Recently, its concerns have been widened to include herbals, traditional and complementary medicines, blood products, biologicals, medical devices and vaccines"
Pharmacovigilance System
Pharmacovigilence system studies the long term and short term adverse drug reaction or simply stated- side effects of medicines. Pharmacovigilance system involves collection, monitoring , researching upon, assessing and evaluating information received from health care workers such as doctors, dentists, pharmacists, nurses and other health professionals for understanding the adverse drug reaction. Pharmacovigilance definition includes monitoring of all pharmaceutical drugs and also other medical products including vaccines, X-ray contrast media, traditional and herbal remedies etc. especially when the reaction is unusual, potentially serious or clinically significant.
Importance of Pharmacovigilance
When a pharmaceutical drug is introduced in the market there are still a lot of things that are unknown about the safety of the new drugs. These medicines are used by various patients for different diseases These people might be using several other drugs and must be following different traditions and diets which may adversely affect the impact of medicine in them. Also the different brands of same medicine might differ in the manner of their production and ingredients. Additionally, adverse drug reactions might also occur when drugs are taken along with traditional and herbal medicines that has also to be monitored through pharmacovigilance. In some cases, adverse drug reaction of certain medicines might occur only in one country's or region's citizens. To prevent all undue physical, mental and financial suffering by patients, pharmacovigilance proves to be an important monitoring system for the safety of medicines in a country with the support of doctors, pharmacists, nurses and other health professionals of the country.
Pharmacovigilance in Different Countries/ Regions
All the regions of the world have their own particular pharmacovigilance system, though based on WHO guidelines.
Pharmacovigilance in Europe
Pharmacovigilance system in Europe is coordinated by the European Medicines Agency (EMA) and conducted by the National Competent Authorities (NCAs). The EMA maintains and develops the pharmacovigilance database comprising all suspected serious adverse drug reactions observed in the European region. Here, the pharmacovigilance system is called EudraVigilance and contains separate but similar databases of human and veterinary reactions.
Pharmacovigilance in United States
Here pharmacovigilance has a multi faceted approach. Three branches of pharmacovigilance in the USA can be defined as the FDA; the pharmaceutical manufacturers; and the academic/non-profit organizations like RADAR and Public Citizen. The US Food and Drug Administration (FDA) receives reports about adverse drug reaction and takes appropriate actions for drug safety.
Pharmacovigilance in India
The Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, Govt. of India launched the National Pharmacovigilance Programme (NPP) in November, 2004. The pharmacovigilance in India was based on the WHO recommendations made in the document titled "Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre". The whole country is divided into zones and regions for operational efficiency. CDSCO, New Delhi is at the top of the hierarchy followed by two zonal pharmacovigilance centers viz, Seth GS Medical College, Mumbai and AIIMS, New Delhi.
To summarize the basic knowledge about pharmacovigilance, it can be said that the information obtained from reports about adverse drug reactions promote drug safety on a local and national level. These reports are entered into the national adverse drug reaction database and analyzed by expert reviewers justifying the whole pharmacovigilance system.
Conclusion:
Despite its 40-year history, pharmacovigilance remains a dynamic clinical and scientific discipline. It continues to play a crucial role in meeting the challenges posed by the ever increasing range and potency of medicines, all of vitamins unpredictable potential for harm.
Reference:
1. WHO, Handbook of resolutions and decisions of the World Health Assembly and Executive Board,Vol 11948-1972,Geneva:WHO,1973.
2. WHO, Effective Communications in Pharmacovigilance: The Erice Report, Uppsala: WHO, 1998.
3. WHO, Medicines Strategy: frame Work for Action in Essential Drugs and Medicines Policy, 2000-2003.
4. WHO Drug information: Consumer reporting of ADRs, 200; 14, pp.211-215.
5. WHO, The Importance of pharmacovigilance : safety Monitoring of medicinal products, WHO 2002
6. WHO, Pharmacovigilance for antiretroviral in resource- poor countries, WHO 2007.
7. WHO, Safety monitoring of medicinal products. : Guidelines for good Clinical Practice (GCP) for trials on pharmaceutical products, Geneva: WHO 1995.
8. WHO, Safety monitoring of medicines: guidelines for setting up and running of pharmacovigilance centre, Geneva: WHO 2000.
9. WHO, Safety of medicines: The Importance of pharmacovigilance, Geneva: WHO 2002.
10. WHO, The Safety of medicines in public health programmes : Integration of pharmacovigilance in to public heal.
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