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Abstract

The science field of pharmacovigilance (PV) is notable for its work on the identification, assessment, mitigation, and prevention of adverse medication responses and issues associated with them, such as allergic reactions. The assessment of the risk vs. benefit medication profile for improved potency with more safety to use various pharmaceuticals in patients suffering from various illnesses is the primary issue of pharmacovigilance. Pharmacovigilance, the process of gathering information and disseminating reports on diverse adverse medication responses among various users, plays a critical role in the healthcare sector in the responsible use of pharmaceuticals in society. India's pharmaceutical business, in terms of capability and ethics, is able to position third globally. In India, a top choice for research and development, new therapeutic compounds, including synthetic and natural ingredients, particular dosage forms, and pharmaceuticals are produced on a big scale. However, for improved safety studies in the pharmaceutical sector, we need a worldwide standardised pharmacovigilance system. This review paper clarifies the significance of excellent communication in the health business and the function it plays in pharmacovigilance.

Keywords

Drug development, adverse event, Pharmacovigilance, Health Profession.

Reference

  1. Mc Bride WG. 1961. Thalidomide and congenital abnormalities. Lancet. 278,358. http://dx.doi.org/10.1016/S0140-6736(61)90927-8
  2. Bégaud B, Chaslerie A, Haramburu F. 1994. Organization and results of drug vigilance in France. Rev Epidemiol Sante Publique. PubMed 42, 416-23.
  3. WHO. The Importance of Pharmacovigilance, Safety Monitoring of medicinal products. World Health Organization 2002.
  4. Report E. Effective communications in Pharmacovigilance. International Conference on Developing Effective Communications in Pharmacovigilance, Erice, Sicily 1997; 24-27.
  5. Shuka SS, Gidwani B, Pandey R, Rao SP, Singh V, et al. 2012. Importance of Pharmacovigilance in Indian Pharmaceutical Industry. Asian J. Res. Pharm. Sci. 2, 4-8.
  6. 6. Hornbuckle K, Wu H-H, Fung MC. 1999. Evaluation of spontaneous adverse event reports by primary reporter - a 15-year review (1983 to 1997). Drug Inf J. 33, 1117-24.
  7. WHO. 2000. Consumer reporting of ADRs. WHO Drug Information. 14, 211-15.
  8. Egberts GPG, Smulderes M, De Konig FHP, et al. 1996. Can adverse drug reactions be detected earlier?: a comparison of reports by patients and professionals. BMJ. 313, 530-31. PubMed http://dx.doi.org/10.1136/bmj.313.7056.530
  9. Norwood PK, Sampson AR. 1988. A statistical methodology for postmarketing surveillance of adverse drug reaction reports. Stat Med. 7, 1023-30. PubMed http://dx.doi.org/10.1002/sim.4780071004
  10. Whitebread S, Hamon J, Bojanic D, Urban L. 2005. Keynote review: in vitro safety pharmacology profiling: an essential tool for successful drug development. Drug Discov Today. 10, 1421-33. PubMed http://dx.doi.org/10.1016/S1359-6446(05)03632-9
  11. McClure DL. 2009. Improving Drug Safety: Active Surveillance Systems Should be Paramount.
  12. Pharmaceutical Medicine. 23, 127-30. http://dx.doi.org/10.1007/BF03256760.
  13. Shibata A, Hauben M. Pharmacovigilance, signal detection and signal intelligence overview. Proceedings of the 14th International Conference on Information Fusion (FUSION-2011). Chicago, IL. 2011; pp. 1-7.
  14. Lopes P, Nunes T, Campos D, Furlong LI, Bauer-Mehren A, et al. 2013. Gathering and Exploring Scientific Knowledge in Pharmacovigilance. PLoS ONE. 8(12), e83016. PubMed http://dx.doi.org/10.1371/journal.pone.0083016.
  15. Stahl M, Edwards IR, Bowring G, Kiuru A, Lindquist M. 2003. Assessing the Impact of Drug Safety Signals from the WHO Database Presented inSIGNAL': Results from a Questionnaire of National Pharmacovigilance Centres. Drug Saf. PubMed 26, 721-27.
  16. Lazarou J, Pomeranz BH, Corey PN. 1998. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 279, 1200-05. PubMed http://dx.doi.org/10.1001/jama.279.15.1200
  17. Meyboom RHB, Lindquist M, Egberts ACG, Edwards IR. 2002. Signal Selection and Follow- Up in Pharmacovigilance. Drug Saf. 25, 459-65. PubMed http://dx.doi.org/10.2165/00002018200225060-00011.
  18. De Bruin ML, Van Puijenbroek EP, Egberts AC, Hoes AW, Leufkens HG. 2002. Nonsedating antihistamine drugs and cardiac arrhythmias– biased risk estimates from spontaneous reporting systems? Br J Clin Pharmacol. 53, 370-74. PubMed http://dx.doi.org/10.1046/j.13652125.2002.01569.x
  19. Coloma PM, Schuemie MJ, Trifirò G, Gini R, Herings R, et al. 2011. Combining electronic healthcare databases in Europe to allow for largescale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol Drug Saf. 20, 1-11. PubMed http://dx.doi.org/10.1002/pds.2053.
  20. Härmark L, van Grootheest AC. 2008. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol. 64, 743-52. PubMed http://dx.doi.org/10.1007/s00228-008-0475-9.
  21. Basic steps in Pharmacovigilance Case Processing [cited on 30/7/2015]; Available at URL:http://www.pharmawisdom.com/Basic-steps-in-Pharmacovigilance-Case rocessing.html

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Prajakta Pujari
Corresponding author

Faculty of pharmacy, Dr. J. J. Magdum Pharmacy College, Jaysingpur

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Sonali Magdum
Co-author

Faculty of pharmacy, Dr. J. J. Magdum Pharmacy College, Jaysingpur

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Kajal Shinde
Co-author

Faculty of pharmacy, Dr. J. J. Magdum Pharmacy College, Jaysingpur

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Darshani Taral
Co-author

Faculty of pharmacy, Dr. J. J. Magdum Pharmacy College, Jaysingpur

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Prajakta Chaugule
Co-author

Faculty of pharmacy, Dr. J. J. Magdum Pharmacy College, Jaysingpur

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Sadhana Pujari
Co-author

Faculty of pharmacy, Dr. J. J. Magdum Pharmacy College, Jaysingpur

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Ravina Kamble
Co-author

Faculty of pharmacy, Dr. J. J. Magdum Pharmacy College, Jaysingpur

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Dhanashree Rajput
Co-author

Faculty of pharmacy, Dr. J. J. Magdum Pharmacy College, Jaysingpur

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S. S. Patil
Co-author

Principal , Dr. J. J. Magdum Pharmacy College, Jaysingpur

Prajakta Pujari, Sonali Magdum, Kajal Shinde, Darshani Taral, Prajakta Chaugule, Sadhana Pujari, Ravina Kamble, Dhanashree Rajput, S. S. Patil, Effective Communication In Pharmacovigilance, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 2, 684-691. https://doi.org/10.5281/zenodo.10702115

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