Abstract:

Pharmacovigilance (PV), defined by the world health organization (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Emergence of PV activities and the awareness would play a vital role in ensuring that doctors, healthcare professional, together with the patient, have enough information to make an educated decision when it comes to choosing a drug for treatment and eventually achieving the patient safety in large. 

References:

[1.] Adis International. The Erice Manifesto: for global reform of the safety of medicines in patient care. Drug Saf 2007; 30:187-90.

[2.] Assessment of the European Community System of Pharmacovigilance. European Medicines Agency 2006. Available via http://www.cbg-meb.nl/NL/docs/nieuws/rapp-fraunhofer.pdf Accessed March 1, 2012.

[3.] Biswas P, Biswas AK. Setting standards for proactive pharmacovigilance in India. Indian J Pharmacol. 2007;39:124–8.

[4.] Chapter 6 of The SAFETY of MEDICINES IN PUBLIC HEALTH PROGRAMMES: Pharmacovigilance an essential tool. WHO book.

[5.] Coombes R. FDA tightens its grip on drug regulation. BMJ 2007; 334:290-1.

[6.] Directive 2010/84/EU. Official Journal of the European Union 2010, Dec 31,L. 348/74-99.

[7.] European Medicine Agency Updates on RMP: EMA website http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_list ing_000360.jsp

[8.] European Risk management Strategy: Achievements to date. European Medicines Agency 2007. Available via http://www.emea.europa.eu/pdfs/human/phv/30816707en.pdf Accessed Dec 18 2007.

[9.] Good Pharmacovigilance Practices. European medicines Agency 2012. Available via http:// www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_0 00345.jsp&mid=#section1 Accessed March 1, 2012.

[10.]   Heath G, Colburn WA. An evolution of drug development and clinical pharmacology during the 20th century. J ClinPharmacol 2000; 40:918-29.

[11.]   Hugman B. The Ericedeclaration : the critical role of communication in drug safety. Drug Saf 2006; 29:91-3.

[12.]   McBride WG. Thalidomide and congenital malformations. Lancet 1961; 2:1358.

[13.]   McClellan M. Drug safety reform at the FDA-pendulum swing or systematic improvement? N EnglJ Med 2007; 356:1700-2.

[14.]   Merck Announces Voluntary Worldwide Withdrawal of VIOXX. Merck & Co. 2004. Available via http://www.merck.com/newsroom/vioxx/pdf/vioxx_press_release_final.pdf Accessed March 1, 2012.

[15.]   Nair MD. Pharmacovigilance: the need for a formal system in India. 2001. Available at the site of Pharmabiz www.pharmabiz.com http://www.pharmabiz.com/article/detnews.asp?articleid = 11329&sectionid = 46 .

[16.]   Protocol for National Pharmacovigilance Program. 2004 Nov; CDSCO, Ministry of Health and Family Welfare, Government of India.

[17.]   Raine JM. Risk management -a European Regulatory View. In: Mann R, Andrews E (eds) Pharmacovigilance.2nd edn 2007. Wiley, Chichester.

[18.]   Regulation 1235/2010. Official Journal of the European Union 2010, Dec 31,L. 348/1-16.

[19.]   REMS update and guidelines by FDA: Website http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM328784.pdf

[20.]   Schedule Y. 2005 Jan; CDSCO, Ministry of Health and Family Welfare, Government of India.

[21.]   Status Report on the Implementation of the European Risk management Strategy. European Medicines Agency 2007. Available via http://www.emea.europa.eu/pdfs/human/phv/16895407en.pdf Accessed Dec 18, 2007.

[22.]   The Importance of Pharmacovigilance. WHO 2002. Available via http://apps.who.int/medicinedocs/en/d/Js4893e/1.html Accessed Jan 20, 2012.

[23.]   VanGrootheest K. The dawn of pharmacovigilance: an historical perspective. Int J Pharm Med 2003; 17:195-200.

[24.]   Waller PC, Evans SJ. A model for the future conduct of pharmacovigilance. Pharmacoepidemiol Drug Saf 2003; 12:17-29.

[25.]   Whitworth DR. India's pharmacovigilance system to monitor adverse reactions of drugs. Available at the site of Regulatory Affairs Focus Magazine www.raps.org http://www.raps.org/s_raps/rafocus_article.asp?TRACKID = &CID = 61&DID = 26350 .

[26.]   Zwillich T. US lawmakers tackle safety reforms at the FDA. Lancet 2007; 369:1989-90.