AN OVERVIEW ON PHARMACOVIGILANCE: A KEY FOR DRUG SAFETY AND MONITORING

  • Vipin Kesharwani Chandra Shekhar Singh College of Pharmacy, Koilaha, Puramufti, Kaushambi, Uttar Pradesh, India
  • Mohd. Asad Farooqui Chandra Shekhar Singh College of Pharmacy, Koilaha, Puramufti, Kaushambi, Uttar Pradesh, India
  • Nikhil Kushwaha Chandra Shekhar Singh College of Pharmacy, Koilaha, Puramufti, Kaushambi, Uttar Pradesh, India
  • Ravi Kesh Singh Chandra Shekhar Singh College of Pharmacy, Koilaha, Puramufti, Kaushambi, Uttar Pradesh, India
  • Pankaj Kumar Jaiswal Department of Pharmaceutical Sciences, Dibrugarh University, Dibrugarh Assam, India

Abstract

Pharmacovigilance outlined by the globe Health Organization (WHO) because the science and series of activities about the detection, evaluation, understanding rejection of adverse impact or Associate in Nursing different drug connected problem’ and a clinical test could be an analysis study in human volunteers to answer specific health queries. Fastidiously conducted clinical trials square measure quickest and safest thanks to realizing treatment that employment in individuals and thanks to improving health.  Play a crucial role in guaranteeing that patient to be provided the safe drug. The Pharmacovigilance has been recognizing to play a crucial role in the rational use of the drug by providing data concerning the adverse impact possess by drug normally population. The information of drug Adverse Drug Reaction (ADRs) are often increased by numerous suggests that such information studies, intensive observation, spontaneous reportage and different new method at dictatorial and scientific level square measure being developed with the intention of step-up Pharmacovigilance. As a result of assessment strategies are not entirely void of individual judgments, integrator reliableness is often low. In conclusions, there's still no methodology universally accepted for casualty assessment of ADRs.


Keywords: Adverse Drug Reaction, Clinical test, Pharmacovigilance, Treatment.

Downloads

Download data is not yet available.

Author Biographies

Vipin Kesharwani, Chandra Shekhar Singh College of Pharmacy, Koilaha, Puramufti, Kaushambi, Uttar Pradesh, India

Chandra Shekhar Singh College of Pharmacy, Koilaha, Puramufti, Kaushambi, Uttar Pradesh, India

Mohd. Asad Farooqui, Chandra Shekhar Singh College of Pharmacy, Koilaha, Puramufti, Kaushambi, Uttar Pradesh, India

Chandra Shekhar Singh College of Pharmacy, Koilaha, Puramufti, Kaushambi, Uttar Pradesh, India

Nikhil Kushwaha, Chandra Shekhar Singh College of Pharmacy, Koilaha, Puramufti, Kaushambi, Uttar Pradesh, India

Chandra Shekhar Singh College of Pharmacy, Koilaha, Puramufti, Kaushambi, Uttar Pradesh, India

Ravi Kesh Singh, Chandra Shekhar Singh College of Pharmacy, Koilaha, Puramufti, Kaushambi, Uttar Pradesh, India

Chandra Shekhar Singh College of Pharmacy, Koilaha, Puramufti, Kaushambi, Uttar Pradesh, India

Pankaj Kumar Jaiswal, Department of Pharmaceutical Sciences, Dibrugarh University, Dibrugarh Assam, India

Department of Pharmaceutical Sciences, Dibrugarh University, Dibrugarh Assam, India

References

1. World Health Organization. The importance of pharmacovigilance – safety monitoring of medicinal products. World Health Organization, Geneva.2002;
2. Shuka SS, Gidwani B, Pandey R, Rao SP, Singh V, Vyas A, Importance pharmacovigilance in Indian Pharmaceutical Industry, Asian Journal of Research in Pharmaceutical Science 2012; (2): 04-08.
3. WHO, Pharmacovigilance, ensuring the safe use of medicines, Geneva WHO.2004;
4. Mann RD, Andrews EB,eds. John Wiley & Sons Ltd, Pharmacovigilance, Chichester. 2002.
5. Lazarou J, Pomeranz BH, Corey PN, Incidence of adverse drug reactions in hospitalized patients, JAMA, 1998; 279:1200–1205.
6. Bord CA, Rachl CL, Adverse drug reactions in United States hospitals. Pharmacotherapy, 2006; 26(5):601–08.
7. Danan G, Benichou C, Causality assessment of adverse reactions to drugs- a novel method based on the conclusions of international consensus meetings: application to druginduced liver injuries, J ClinEpidemiol, 1993; 46(1):132-142.
8. Blanc S, Leuenberger P, Berger JP, Brooke EM, .Schelling JL, Judgments of trained observers on adverse drug reactions, ClinPharmacol Ther 1999; (25):493-498.
9. Taofikat BA, Savovi J, Ernst E, Methods for Causality Assessment of Adverse Drug Reactions A Systematic Review, Drug Safety, 2008; 31(1):21-37.
10. Jadhav S, Chakraborthy G, Pharmacovigilance in India Need of Hour, Journal of Advances in Pharmacy and Healthcare Research (JAPHR) 2011; 101-03.
11. Amarnath S, Jaikumar S, Basalingappa S, Thulasimani M, Ramaswamy S, Pharmacovigilance for Health Care Professional Students, Research Journal of Pharmaceutical, Biological and Chemical Sciences (RJPBCS)4 January-March 2013; 1204-1217.
12. Muraraiah S, Rajarathna K, Sreedhar D, Basavalingu D, Jayanthi C.R, A questionnaire study to assess the knowledge, attitude and practice of Pharmacovigilance in a paediatric tertiary care centre, Journal of Chemical and Pharmaceutical Research, 2011; 416-422.
13. Ghosh R, Bhatia M.S, Bhattacharya S.K, Pharmacovigilance: Master Key to Drug Safety Monitoring and its Status in India: Delhi Psychiatry Journal, 15 October 2012; 412-415.
14. Kulkarni M.D., Baig M.S, Chandaliya K.C, Doifode S.M, Razvi S.U, Sidhu N.S, Knowledge Attitude and Practice of Pharmacovigilance among Prescribers of Government Medical College and Hospital, Aurangabad (Maharashtra), International Journal of Pharmacology and Therapeutics, 2013; 3:10-18.
15. WHO, Pharmacovigilance: ensuring the safe use of medicines, Geneva: WHO.2004;
16. Zarin DA, Young JL, West JC, Challenges to evidence based medicine: a comparison of patients and treatments in randomized controlled trials with patients and treatments in a practice research network. Soc Psychiatry Psychiatr Epidemiol, 2005; 4027–35.
17. Dangoumau J, Evreux JC, Jouglard J, Mehtod for determination of undesirable effects of drugs, Therapie, 1978; 33(3):373-81.
18. Kramer MS, Leventhal JM, Hutchinson TA, Feinstein AR, An algorithm for the operational assessment of adverse drug reactions: I. Background, description, and instructions for use. JAMA, 1979; 242(7):623-32.
19. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, A method for estimating the probability of adverse drug reactions.ClinPharmacolTher1981; 30(2):239-45.
20. Lagier G, Vincens M, Castot A, Imputability in drug monitoring: Principles of the balanced drug reaction assessment method and principal errors to avoid. Therapie, 1983; 38(3):303-18.
21. Venulet J, Ciucci A, Berneker GC, Standardized assessment of drug-adverse reaction associations – Rationale and experience. Int J ClinPharmacolTherToxico, 1980; 18(9):381-8.
22. Loupi E, Ponchon AC, Ventre JJ, Evreux JC, Imputability of a teratogenic effect. Therapie, 1986;41(3):207-10.
23. Danan G, Benichou C, Causality assessment of adverse reactions to drugs--I. A novel method based on the conclusions of international consensus meetings: Application to drug-induced liver injuries, J ClinEpidemiol, 1993; 46(11):1323-30.
24. Mashford ML, The Australian method of drug-event assessment: Special workshop – regulatory. Drug Inf J, 1984; 18(3-4):271-273.
25. Bhosale U, Jaiswal S, Yegnanarayan R, Godbole G, A Pharmacovigilance Study of Anti- Asthmatic Agents in Patients of Bronchial Asthma at a Tertiary Care Hospital, Journal of Clinical & Experimental Research,1May-August 2013; 26-30.
26. Sharma S, Phadnis P, Gajbhiye S, Pharmacovigilance: Its Awareness and Impact Care Teaching Medical College in Central India Impact- Study in a Tertiary care Teaching Medical College in Central India, International Journal of Pharmaceutical Research and Bio- Science (IJPRBS), 2013; 2:234-247.
27. Padmavathi GV, Beere N, Divakara P, Suresh KP, Surendranath A, Patel RS, Screenplay of pharmacovigilance among nursing staff in Bangalore,2 February 2013; 365-370.
28. Maiti B, Nagori B.P., Singh R, Kumar P, Upadhyay N, Recent Trends in Herbal Drugs: A Review, International Journal of Drug Research and Technology, 2011; 117-25.
29. Chakraverty R, Banerjee A, Emerging Issues in Pharmacovigilance of Herbal Medicines in India: International Journal of Pharmaceutical Sciences Review and Research, 20 May -Jun 2013; 40-42.
30. Rama P, Prudence AR, Georgy A, Pharmaovigilance: Perspectives and Future Challenges in Indian Scenario, Asian Journal of Pharmaceutical and Clinical Research, 2011; 4:01-04.
31. Rohilla A, Kumar V, Sharma KM, Dahiya A, Kushnoor A, Pharmacovigilance: Needs and Objectives, Journal of Advanced Pharmacy Education & Research, 2 Oct-Dec 2012; 201-205.
32. Leon L, Herbert A. Liberman, Joseph L. Kanig, Varghese Publishing House, Hind Rajasthan Building Dadar, Mumbai, 3rdEdition, 239-240.
33. CIOMS Working Group VIII. Practical aspects of signal detection in pharmacovigilance. Council for International Organizations of Medical Sciences (CIOMS), Geneva.2 010.
34. Information about clinical trial. Available from :URLhttp://www.temple.edu/pascope/about-trials.html
35. Clinical trial wikipedia, the free encyclopedia: Available from, URLhttp://en.wikipedia.org/ wiki/clinical_trial Jan 28 2008;
36. Kulkarni SK, Hand Book of Experimental Pharmacology, 3rd ed. Vallabh Prakashan New Delhi, 2004; P21.
Statistics
46 Views | 101 Downloads
How to Cite
Kesharwani, V., Farooqui, M., Kushwaha, N., Singh, R., & Jaiswal, P. (2018). AN OVERVIEW ON PHARMACOVIGILANCE: A KEY FOR DRUG SAFETY AND MONITORING. Journal of Drug Delivery and Therapeutics, 8(5), 130-135. https://doi.org/10.22270/jddt.v8i5.1970