Pharmacovigilance: A worldwide master key for drug safety monitoring

G. Jeetu, G. Anusha

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The current global network of pharmacovigilance centers, coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review. This would consider litigious and important drug safety issues that have the potential to affect public health adversely beyond national boundaries. Recently, pharmacovigilance has been confined, mainly to detect adverse drug events that were previously either unknown or poorly understood. Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs. In this review we will discuss about drug safety, worldwide pharmacovigilance centers and their role, benefits and challenges of pharmacovigilance and its future consideration in healthcare sectors.
Original languageEnglish
Pages (from-to)315-320
Number of pages6
JournalJournal of Young Pharmacists
Volume2
Issue number3
DOIs
Publication statusPublished - 2010
Externally publishedYes

Fingerprint

Pharmacovigilance
Drug Monitoring
Safety
Drug-Related Side Effects and Adverse Reactions
Pharmaceutical Preparations
Public Health Practice
Health Care Sector
Drug and Narcotic Control
Public Health

Cite this

Jeetu, G. ; Anusha, G. / Pharmacovigilance: A worldwide master key for drug safety monitoring. In: Journal of Young Pharmacists. 2010 ; Vol. 2, No. 3. pp. 315-320.
@article{c5710b7b6aa14b6e9d94e1bc34bff066,
title = "Pharmacovigilance: A worldwide master key for drug safety monitoring",
abstract = "Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The current global network of pharmacovigilance centers, coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review. This would consider litigious and important drug safety issues that have the potential to affect public health adversely beyond national boundaries. Recently, pharmacovigilance has been confined, mainly to detect adverse drug events that were previously either unknown or poorly understood. Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs. In this review we will discuss about drug safety, worldwide pharmacovigilance centers and their role, benefits and challenges of pharmacovigilance and its future consideration in healthcare sectors.",
author = "G. Jeetu and G. Anusha",
note = "Cited By :14 Export Date: 10 November 2017 Correspondence Address: Jeetu, G.; Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka, India; email: jeetu.gangil@gmail.com Tradenames: pandemrix References: Looking at the Pharmacovigilance: Ensuring the Safe Use of Medicines, , http://www.whqlibdoc.who.int/hq/2004/WHO_EDM_2004.8.pdf, Geneva: World Health Organization WHO Policy Perspectives on Medicines. Geneva: WHO 2004; Harmark, L., Van Grootheest, A.C., Pharmacovigilance: Methods, recent developments and future perspectives (2008) Eur J Clin Pharmacol, 64, pp. 743-752; Biswas, P., Biswas, A., Setting standards for proactive pharmacovigilance in India: The way forward (2007) Indian J Pharmacol, 39, pp. 124-128; (2002) The Importance of Pharmacovigilance Safety Monitoring of Medicinal Products, , http://www.apps.who.int/medicinedocs/en/d/Js4893e/, WHO Lib Catalog; (1973) Handbook of Resolutions and Decisions of the World Health Assembly and Executive Board, , http://whqlibdoc.who.int/wha_eb_handbooks/9241652063_Vol2.pdf, whqlibdoc.who.int [homepage on the Internet]. Geneva: World Health Organization. [Last cited on 2009 Dec 26]; Lared, N.L., (2003) Pharmacists′ Role in Reporting Adverse Drug Reactions in An International Perspective, , http://www.lareb.nl/documents/pds2004_1291.pdf, last cited on 2010 Jan 28; WHO Medicines Strategy: Framework for Action in Essential Drugs and Medicines Policy 2000-2003, , http://www.apps.who.int/medicinedocs/en/d/Jwhozip16e/8.html, last cited on 2010 Jan 10; Olsson, S., The role of the WHO Programme for International Drug Monitoring in coordinating worldwide drug safety efforts (1998) Drug Saf, 19, pp. 1-10; Coulter, D.M., The New Zealand intensive medicines monitoring programme in proactive safety surveillance (2000) Pharmacoepidemiol Drug Saf, 9, pp. 273-280; MacKay, F.J., Post-marketing studies: The work of the drug safety research unit (1998) Drug Saf, 19, pp. 343-353; Folb, P.I., Ten Ham, M., Drug monitoring in developing countries: A drug regulator′s perspective (1995) Drug Inf J, 29, pp. 303-305; Talbot, J.C., Nilsson, B.S., Pharmacovigilance in the pharmaceutical industry (1998) Br J Clin Pharmacol, 45, pp. 427-431; Moore, N., The role of the clinical pharmacologist in the management of ADRs (2001) Drug Saf, 24, pp. 1-7; Hall, M., McCormack, P., Arthurs, N., Feely, J., The spontaneous reporting of ADRs by nurses (1995) Br J Clin Pharmacol, 40, pp. 173-175; Hornbuckle, K., Wu, H.H., Fung, M.C., Evaluation of spontaneous adverse event reports by primary reporter: A 15-year review (1983 to 1997) (1999) Drug Inf J, 33, pp. 1117-1124; Cioms, C.H., (1998) Geneva. Benefit-risk Balance for Marketed Drugs. Evaluating Safety Signals: Report of CIOMS Working Group IV, , http://www.cioms.ch/publications/g4-benefit-risk.pdf, CIOMS, Geneva [last cited on 2010 Jan 15]; Lazarou, J., Pomeranz, B.H., Corey, P.N., Incidence of ADRs in hospitalized patients: A meta-analysis of prospective studies (1998) J Am Med Assoc, 279, pp. 1200-1205; White, T.J., Arakelian, A., Rho, J.P., Counting the costs of drug-related adverse events (1999) Pharmacoeconomics, 15, pp. 445-458; Avorn, J., Solomon, D.H., Cultural and economic factors that (mis)shape antibiotic use: The nonpharmacologic basis of therapeutics (2000) Ann Intern Med, 133, pp. 128-135; Ball, L.K., Evans, G., Bostrom, A., Risky business: Challenges in vaccine risk communication (1998) Pediatrics, 101, pp. 453-458; Bapna, J.S., Tripathi, C.D., Tekur, U., Drug utilization patterns in the third world (1996) Pharmacoeconomics, 9, pp. 286-294; Kane, A., Lloyd, J., Zaffran, M., Simonsen, L., Kane, M., Transmission of hepatitis B, hepatitis C, and human immunodeficiency virus through safe injections in the developing world: Mode-based regional estimates (1999) Bull World Health Organ, 78, pp. 801-807; De Vries, C.S., Duggan, C.A., Tromp, T.F., De Jong-Van Den Berg, L.T., Changing prescribing in the light of tolerability concerns: How is this best achieved? (1999) Drug Saf, 21, pp. 153-160; Sleath, B., Svarstad, B., Roter, D., Physician motivation for non-scientific drug prescribing (1997) Soc Sci Med, 44, pp. 541-548; Vaccine safety. Vaccine Safety Advisory Committee (1999) Wkly Epidemiol Rec, 74, pp. 337-340; (2009) Pandemic Pharmacovigilance Weekly Update Status, , http://www.ema.europa.eu/pdfs/influenza/78468109en.pdf, last cited on 2010 Jan 12; (1997) Effective Communications in Pharmacovigilance. The Erice Report. International Conference on Developing Effective Communications in Pharmacovigilance, , http://www.who-umc.org/DynPage.aspx?id=22690, Erice, Sicily. [last cited on 2010 Jan 20]; Ioannidis, J.P., Lau, J., Completeness of safety reporting in randomized trials: An evaluation of 7 medical areas (2001) JAMA, 285, pp. 437-443; Waller, P.C., Wood, S.M., Langman, M.J., Breckenridge, A.M., Rawlins, M.D., Review of company postmarketing surveillance studies (1992) BMJ, 304, pp. 1470-1472",
year = "2010",
doi = "10.4103/0975-1483.66802",
language = "English",
volume = "2",
pages = "315--320",
journal = "Journal of Young Pharmacists",
issn = "0975-1483",
publisher = "E-Flow Medknow Publications",
number = "3",

}

Pharmacovigilance: A worldwide master key for drug safety monitoring. / Jeetu, G.; Anusha, G.

In: Journal of Young Pharmacists, Vol. 2, No. 3, 2010, p. 315-320.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Pharmacovigilance: A worldwide master key for drug safety monitoring

AU - Jeetu, G.

AU - Anusha, G.

N1 - Cited By :14 Export Date: 10 November 2017 Correspondence Address: Jeetu, G.; Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka, India; email: jeetu.gangil@gmail.com Tradenames: pandemrix References: Looking at the Pharmacovigilance: Ensuring the Safe Use of Medicines, , http://www.whqlibdoc.who.int/hq/2004/WHO_EDM_2004.8.pdf, Geneva: World Health Organization WHO Policy Perspectives on Medicines. Geneva: WHO 2004; Harmark, L., Van Grootheest, A.C., Pharmacovigilance: Methods, recent developments and future perspectives (2008) Eur J Clin Pharmacol, 64, pp. 743-752; Biswas, P., Biswas, A., Setting standards for proactive pharmacovigilance in India: The way forward (2007) Indian J Pharmacol, 39, pp. 124-128; (2002) The Importance of Pharmacovigilance Safety Monitoring of Medicinal Products, , http://www.apps.who.int/medicinedocs/en/d/Js4893e/, WHO Lib Catalog; (1973) Handbook of Resolutions and Decisions of the World Health Assembly and Executive Board, , http://whqlibdoc.who.int/wha_eb_handbooks/9241652063_Vol2.pdf, whqlibdoc.who.int [homepage on the Internet]. Geneva: World Health Organization. [Last cited on 2009 Dec 26]; Lared, N.L., (2003) Pharmacists′ Role in Reporting Adverse Drug Reactions in An International Perspective, , http://www.lareb.nl/documents/pds2004_1291.pdf, last cited on 2010 Jan 28; WHO Medicines Strategy: Framework for Action in Essential Drugs and Medicines Policy 2000-2003, , http://www.apps.who.int/medicinedocs/en/d/Jwhozip16e/8.html, last cited on 2010 Jan 10; Olsson, S., The role of the WHO Programme for International Drug Monitoring in coordinating worldwide drug safety efforts (1998) Drug Saf, 19, pp. 1-10; Coulter, D.M., The New Zealand intensive medicines monitoring programme in proactive safety surveillance (2000) Pharmacoepidemiol Drug Saf, 9, pp. 273-280; MacKay, F.J., Post-marketing studies: The work of the drug safety research unit (1998) Drug Saf, 19, pp. 343-353; Folb, P.I., Ten Ham, M., Drug monitoring in developing countries: A drug regulator′s perspective (1995) Drug Inf J, 29, pp. 303-305; Talbot, J.C., Nilsson, B.S., Pharmacovigilance in the pharmaceutical industry (1998) Br J Clin Pharmacol, 45, pp. 427-431; Moore, N., The role of the clinical pharmacologist in the management of ADRs (2001) Drug Saf, 24, pp. 1-7; Hall, M., McCormack, P., Arthurs, N., Feely, J., The spontaneous reporting of ADRs by nurses (1995) Br J Clin Pharmacol, 40, pp. 173-175; Hornbuckle, K., Wu, H.H., Fung, M.C., Evaluation of spontaneous adverse event reports by primary reporter: A 15-year review (1983 to 1997) (1999) Drug Inf J, 33, pp. 1117-1124; Cioms, C.H., (1998) Geneva. Benefit-risk Balance for Marketed Drugs. Evaluating Safety Signals: Report of CIOMS Working Group IV, , http://www.cioms.ch/publications/g4-benefit-risk.pdf, CIOMS, Geneva [last cited on 2010 Jan 15]; Lazarou, J., Pomeranz, B.H., Corey, P.N., Incidence of ADRs in hospitalized patients: A meta-analysis of prospective studies (1998) J Am Med Assoc, 279, pp. 1200-1205; White, T.J., Arakelian, A., Rho, J.P., Counting the costs of drug-related adverse events (1999) Pharmacoeconomics, 15, pp. 445-458; Avorn, J., Solomon, D.H., Cultural and economic factors that (mis)shape antibiotic use: The nonpharmacologic basis of therapeutics (2000) Ann Intern Med, 133, pp. 128-135; Ball, L.K., Evans, G., Bostrom, A., Risky business: Challenges in vaccine risk communication (1998) Pediatrics, 101, pp. 453-458; Bapna, J.S., Tripathi, C.D., Tekur, U., Drug utilization patterns in the third world (1996) Pharmacoeconomics, 9, pp. 286-294; Kane, A., Lloyd, J., Zaffran, M., Simonsen, L., Kane, M., Transmission of hepatitis B, hepatitis C, and human immunodeficiency virus through safe injections in the developing world: Mode-based regional estimates (1999) Bull World Health Organ, 78, pp. 801-807; De Vries, C.S., Duggan, C.A., Tromp, T.F., De Jong-Van Den Berg, L.T., Changing prescribing in the light of tolerability concerns: How is this best achieved? (1999) Drug Saf, 21, pp. 153-160; Sleath, B., Svarstad, B., Roter, D., Physician motivation for non-scientific drug prescribing (1997) Soc Sci Med, 44, pp. 541-548; Vaccine safety. Vaccine Safety Advisory Committee (1999) Wkly Epidemiol Rec, 74, pp. 337-340; (2009) Pandemic Pharmacovigilance Weekly Update Status, , http://www.ema.europa.eu/pdfs/influenza/78468109en.pdf, last cited on 2010 Jan 12; (1997) Effective Communications in Pharmacovigilance. The Erice Report. International Conference on Developing Effective Communications in Pharmacovigilance, , http://www.who-umc.org/DynPage.aspx?id=22690, Erice, Sicily. [last cited on 2010 Jan 20]; Ioannidis, J.P., Lau, J., Completeness of safety reporting in randomized trials: An evaluation of 7 medical areas (2001) JAMA, 285, pp. 437-443; Waller, P.C., Wood, S.M., Langman, M.J., Breckenridge, A.M., Rawlins, M.D., Review of company postmarketing surveillance studies (1992) BMJ, 304, pp. 1470-1472

PY - 2010

Y1 - 2010

N2 - Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The current global network of pharmacovigilance centers, coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review. This would consider litigious and important drug safety issues that have the potential to affect public health adversely beyond national boundaries. Recently, pharmacovigilance has been confined, mainly to detect adverse drug events that were previously either unknown or poorly understood. Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs. In this review we will discuss about drug safety, worldwide pharmacovigilance centers and their role, benefits and challenges of pharmacovigilance and its future consideration in healthcare sectors.

AB - Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The current global network of pharmacovigilance centers, coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review. This would consider litigious and important drug safety issues that have the potential to affect public health adversely beyond national boundaries. Recently, pharmacovigilance has been confined, mainly to detect adverse drug events that were previously either unknown or poorly understood. Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs. In this review we will discuss about drug safety, worldwide pharmacovigilance centers and their role, benefits and challenges of pharmacovigilance and its future consideration in healthcare sectors.

U2 - 10.4103/0975-1483.66802

DO - 10.4103/0975-1483.66802

M3 - Article

VL - 2

SP - 315

EP - 320

JO - Journal of Young Pharmacists

JF - Journal of Young Pharmacists

SN - 0975-1483

IS - 3

ER -