Skip to content
2000
  1. Home
  2. A-Z Publications
  3. Current Indian Science
  4. Volume 2, Issue 1
  5. Article
Volume 2, Issue 1
  • ISSN: 2210-299X
  • E-ISSN: 2210-3007
file format pdf download PDF
side by side viewer icon HTML

Abstract

The review explores the vital dimensions of pharmacovigilance (PV) and adverse drug reaction (ADR) reporting in the healthcare industry, highlighting their importance for public health and patient safety. The review follows the development of PV from its historical beginnings in India, highlighting significant turning points and legislative frameworks that have influenced modern practices. Sibutramine, a well-known medication, is investigated to highlight the significance of watchful PV systems. Meanwhile, ADR reporting is significant in healthcare because it directly impacts public health and patient safety. However, there is still a need to address issues like healthcare providers' ignorance and underreporting. The suggested solution is to establish Regional Reporting Centres (RRCs), with successful models demonstrating the benefits they provide, including improved data collection and regional assistance. Despite the advantages, setting up RRCs has its share of difficulties, such as coordination and resource allocation. Effective RRC implementation improves ADR reporting, as shown by case studies and success stories. In order to improve ADR reporting and PV procedures, the research ends with suggestions for the future that call for more regulatory assistance, more training for healthcare workers, and public awareness campaigns.

© 2024 The Author(s). Published by Bentham Science Publisher.
This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Loading

Article metrics loading...

/content/journals/cis/10.2174/012210299X326236240821113120
2024-10-22
2025-03-01

  • From This Site

    /content/journals/cis/10.2174/012210299X326236240821113120
    dcterms_title,dcterms_subject,pub_keyword
    -contentType:Contributor -contentType:Concept -contentType:Institution
    10
    5
The full text of this item is not currently available.

References

  1. WHO Meeting on International Drug Monitoring: the Role of National Centres (1971: Geneva, Switzerland) & World Health Organization. (1972). International drug monitoring : the role of national centres , report of a WHO meeting, held in Geneva from 20 to 25 September 1971.2015Available from: https://iris.who.int/handle/10665/ 40968(accessed on 12-8-2024)
  2. BouvyJ.C. De BruinM.L. KoopmanschapM.A. Epidemiology of adverse drug reactions in Europe: a review of recent observational studies.Drug Saf.201538543745310.1007/s40264‑015‑0281‑025822400
     [Google Scholar]
  3. LazarouJ. PomeranzB.H. CoreyP.N. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies.JAMA1998279151200120510.1001/jama.279.15.12009555760
     [Google Scholar]
  4. European Commission Proposal for a Regulation Amending, as Regards Pharmacovigilance of Medicinal Products for Human Use. Regulation (EC) No 726/2004.Impact Assess.20142008•••http://ec.europa.eu/health/files/pharmacos/pharmpack_12_2008/pharmacovigilance-ia-vol1_en.pdfAccessed
     [Google Scholar]
  5. PirmohamedM. JamesS. MeakinS. GreenC. ScottA.K. WalleyT.J. FarrarK. ParkB.K. BreckenridgeA.M. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients.BMJ20043297456151910.1136/bmj.329.7456.1515231615
     [Google Scholar]
  6. CullenD.J. SweitzerB.J. BatesD.W. BurdickE. EdmondsonA. LeapeL.L. Preventable adverse drug events in hospitalized patients.Crit. Care Med.19972581289129710.1097/00003246‑199708000‑000149267940
     [Google Scholar]
  7. The World Health Organization Pharmacovigilance.Available from:http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/(accessed on 12-8-2024)
  8. PalS.N. DuncombeC. FalzonD. OlssonS. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems.Drug Saf.2013362758110.1007/s40264‑012‑0014‑623329541
     [Google Scholar]
  9. RossiA.C. KnappD.E. AnelloC. O’NeillR.T. GrahamC.F. MendelisP.S. StanleyG.R. Discovery of adverse drug reactions. A comparison of selected phase IV studies with spontaneous reporting methods.JAMA1983249162226222810.1001/jama.1983.033304000720296834622
     [Google Scholar]
  10. HazellL. ShakirS.A.W. Under-reporting of adverse drug reactions : a systematic review.Drug Saf.200629538539610.2165/00002018‑200629050‑0000316689555
     [Google Scholar]
  11. MannR.D. AndrewsE.B. Pharmacovigilance.John Wiley & Sons2007
     [Google Scholar]
  12. McbrideW.G. Thalidomide and congenital abnormalities.Lancet19612787216135810.1016/S0140‑6736(61)90927‑8
     [Google Scholar]
  13. MooreN. PauxG. BegaudB. BiourM. LoupiE. BoismareF. RoyerR.J. Adverse drug reaction monitoring: doing it the French way.Lancet198532684631056105810.1016/S0140‑6736(85)90918‑32865527
     [Google Scholar]
  14. DunlopD. [Pharmacovigilance in the framework of recording and control of drugs in the United Kingdom].Therapie19742967998044462229
     [Google Scholar]
  15. BlinP. Dureau-PourninC. LassalleR. JovéJ. Thomas-DelecourtF. Droz-PerroteauC. DanchinN. MooreN. Outcomes in patients after myocardial infarction similar to those of the PEGASUS‐TIMI 54 trial: A cohort study in the French national claims database.Br. J. Clin. Pharmacol.20178392056206510.1111/bcp.1329128345154
     [Google Scholar]
  16. Batel-MarquesF. PenedonesA. MendesD. AlvesC. A systematic review of observational studies evaluating costs of adverse drug reactions.Clinicoecon. Outcomes Res.2016841342610.2147/CEOR.S11568927601925
     [Google Scholar]
  17. LundkvistJ. JönssonB. Pharmacoeconomics of adverse drug reactions.Fundam. Clin. Pharmacol.200418327528010.1111/j.1472‑8206.2004.00239.x15147278
     [Google Scholar]
  18. Rodríguez-MonguióR. OteroM.J. RoviraJ. Assessing the economic impact of adverse drug effects.PharmacoEconomics200321962365010.2165/00019053‑200321090‑0000212807365
     [Google Scholar]
  19. FineM. Quantifying the impact of NSAID-associated adverse events.Am. J. Manag. Care20131914Suppl.s267s27224494609
     [Google Scholar]
  20. SienkiewiczK. BurzyńskaM. Rydlewska-LiszkowskaI. SienkiewiczJ. GaszyńskaE. The importance of direct patient reporting of adverse drug reactions in the safety monitoring process.Int. J. Environ. Res. Public Health202119141310.3390/ijerph1901041335010673
     [Google Scholar]
  21. RegułaJ. WocialT. KraszewskaE. ButrukE. Nonsteroidal anti-inflammatory drugs usage in Poland—A questionnaire study in 38 thousand patients.Gastroenterol. Kliniczna201127278
     [Google Scholar]
  22. PrakasamD. WongA.L. SmithburgerP.L. BuckleyM.S. Kane-GillS.L. Benefits of Patient/Caregiver Engagement in Adverse Drug Reaction Reporting Compared With Other Sources of Reporting in the Inpatient Setting: A Systematic Review.J Patient Saf.2021178e765e77210.1097/PTS.000000000000073432555051
     [Google Scholar]
  23. InácioP. CavacoA. AiraksinenM. The value of patient reporting to the pharmacovigilance system: a systematic review.Br. J. Clin. Pharmacol.201783222724610.1111/bcp.1309827558545
     [Google Scholar]
  24. AveryA.J. AndersonC. BondC.M. FortnumH. GiffordA. HannafordP.C. HazellL. KrskaJ. LeeA.J. McLernonD.J. MurphyE. ShakirS. WatsonM.C. Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys.Health Technol. Assess.201115201234, iii-iv10.3310/hta1520021545758
     [Google Scholar]
  25. RolfesL. van HunselF. WilkesS. van GrootheestK. van PuijenbroekE. Adverse drug reaction reports of patients and healthcare professionals—differences in reported information.Pharmacoepidemiol. Drug Saf.201524215215810.1002/pds.368725079444
     [Google Scholar]
  26. TokiT. OnoS. Spontaneous reporting on adverse events by consumers in the United States: an analysis of the food and drug administration adverse event reporting system database.Drugs Real World Outcomes20185211712810.1007/s40801‑018‑0134‑029725886
     [Google Scholar]
  27. MaQ. LuA.Y.H. Pharmacogenetics, pharmacogenomics, and individualized medicine.Pharmacol. Rev.201163243745910.1124/pr.110.00353321436344
     [Google Scholar]
  28. LihiteR.J. LahkarM. An update on the pharmacovigilance programme of India.Front. Pharmacol.2015619410.3389/fphar.2015.0019426441651
     [Google Scholar]
  29. GuptaY.K. Pharmacovigilance Programme for India.2010Available from:http://www.pharmabiz.com(accessed on 12-8-2024)
  30. KalaiselvanV. SharmaS. SinghG.N. Adverse reactions to contrast media: an analysis of spontaneous reports in the database of the pharmacovigilance programme of India.Drug Saf.201437970371010.1007/s40264‑014‑0202‑725085041
     [Google Scholar]
  31. RehanH.S. Status of pharmacovigilance program of India.2013Available from:http://www.tanuvas.tn.nic.in/tnjvas/tnjvas/vol9(6)/45-48.pdf(accessed on 12-8-2024)
  32. US Food and Drug Administration. Prescribing information: resources and review process.2016Available from:https://www.fda.gov/media/ 100510/download(accessed on 12-8-2024)
  33. US Food and Drug Administration.Available from:https://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=201.56(accessed on 12-8-2024)2019
  34. 2011Available from:https://www.fda.gov/files/drugs/published/War nings-and-Precautions–Contraindications–and-Boxed-Warning-Sections-of-Labeling-for-Human-Prescription-Drug-and-Biological-Products-%E2%80%94-Content-and-Format.pdf (accessed on 12-8- 2024)
  35. Guidance for industry: adverse reactions section of labeling for human prescription drug and biological products – content and format.2006Available from:https://www.hhs.gov/guidance/document/adverse-reactions-section-labeling-human-prescription-drug-and-biological-products-content(accessed on 12-8-2024)
  36. Safety labeling changes – implementation of section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act.2013Available from:https://www.fda.gov/media/116594/download(accessed on 12-8-2024)
  37. LucasS. AilaniJ. SmithT.R. AbdrabbohA. XueF. NavettaM.S. Pharmacovigilance: reporting requirements throughout a product’s lifecycle.Ther. Adv. Drug Saf.20221310.1177/2042098622112500636187302
     [Google Scholar]
  38. US Food and Drug Administration. Good pharmacovigilance practices and pharmacoepidemiologic assessment.Rockville, MDUS Department of Health and Human Services2005
     [Google Scholar]
  39. MunshiR.P. BelhekarM.N. TaurS.R. A study of agreement between the Naranjo algorithm and WHO-UMC criteria for causality assessment of adverse drug reactions.Indian J. Pharmacol.201446111712010.4103/0253‑7613.12519224550597
     [Google Scholar]
  40. KoutkiasV.G. JaulentM.C. Computational approaches for pharmacovigilance signal detection: toward integrated and semantically-enriched frameworks.Drug Saf.201538321923210.1007/s40264‑015‑0278‑825749722
     [Google Scholar]
  41. Benefit-risk balance for marketed drugs: evaluating safety signals: report of CIOMS Working Group IV.e Council for International Organizations of Medical Sciences (CIOMS)1998
     [Google Scholar]
  42. KumarA. Pharmacovigilance: Importance, concepts, and processes.Am. J. Health Syst. Pharm.201774860661210.2146/ajhp15103128235869
     [Google Scholar]
  43. LiM. CheungB.M.Y. Pharmacotherapy for obesity.Br. J. Clin. Pharmacol.200968680481010.1111/j.1365‑2125.2009.03453.x20002075
     [Google Scholar]
  44. NisoliE. CarrubaM.O. An assessment of the safety and efficacy of sibutramine, an anti‐obesity drug with a novel mechanism of action.Obesity Rev.20001,2127139
     [Google Scholar]
  45. ArterburnD.E. CraneP.K. VeenstraD.L. The efficacy and safety of sibutramine for weight loss: a systematic review.Arch. Intern. Med.20041649994100310.1001/archinte.164.9.99415136309
     [Google Scholar]
  46. CuellarG.E.M. RuizA.M. MonsalveM.C.R. BerberA. Six-month treatment of obesity with sibutramine 15 mg; a double-blind, placebo-controlled monocenter clinical trial in a Hispanic population.Obes. Res.200081718210.1038/oby.2000.1010678261
     [Google Scholar]
  47. NisoliE. CarrubaM.O. A benefit-risk assessment of sibutramine in the management of obesity.Drug Saf.200326141027104810.2165/00002018‑200326140‑0000414583064
     [Google Scholar]
  48. JordanJ. ScholzeJ. MatibaB. WirthA. HaunerH. SharmaA.M. Influence of Sibutramine on blood pressure: evidence from placebo-controlled trials.Int. J. Obes.200529550951610.1038/sj.ijo.080288715685250
     [Google Scholar]
  49. Torp-PedersenC. CatersonI. CoutinhoW. FinerN. Van GaalL. MaggioniA. SharmaA. BriscoW. DeatonR. ShepherdG. JamesP. SCOUT Investigators Cardiovascular responses to weight management and sibutramine in high-risk subjects: an analysis from the SCOUT trial.Eur. Heart J.200728232915292310.1093/eurheartj/ehm21717595194
     [Google Scholar]
  50. AstrupA. Drug management of obesity--efficacy versus safety.N. Engl. J. Med.2010363328829010.1056/NEJMe100407620647205
     [Google Scholar]
  51. World Health Organization.What is Pharmacovigilance?2002Available from: https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance#:~:text=Pharmacovigilance%20is%20the%20science%20and,they%20are%20authorized%20for%20use.(accessed on 12-8-2024)
  52. The importance of pharmacovigilance.2002Available from: https://www.who.int/publications/i/item/10665-42493(accessed on 12-8-2024)
  53. KimJ.H. ScialliA.R. Thalidomide: the tragedy of birth defects and the effective treatment of disease.Toxicol. Sci.201112211610.1093/toxsci/kfr08821507989
     [Google Scholar]
  54. Premarketing Risk Assessment.2005Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarketing-risk-assessment(accessed on 12-8-2024)
  55. NaranjoC.A. BustoU. SellersE.M. Difficulties in assessing adverse drug reactions in clinical trials.Prog. Neuropsychopharmacol. Biol. Psychiatry198264-665165710.1016/S0278‑5846(82)80162‑06761768
     [Google Scholar]
  56. BerlinJ.A. GlasserS.C. EllenbergS.S. Adverse event detection in drug development: recommendations and obligations beyond phase 3.Am. J. Public Health20089881366137110.2105/AJPH.2007.12453718556607
     [Google Scholar]
  57. InmanW.H.W. VesseyM.P. WesterholmB. EngelundA. Thromboembolic disease and the steroidal content of oral contraceptives. A report to the Committee on Safety of Drugs.BMJ19702570320320910.1136/bmj.2.5703.2035443406
     [Google Scholar]
  58. BergmanU. BomanG. WiholmB.E. Epidemiology of adverse drug reactions to phenformin and metformin.BMJ19782613546446610.1136/bmj.2.6135.464678924
     [Google Scholar]
  59. StolleyP.D. Asthma mortality. Why the United States was spared an epidemic of deaths due to asthma.Am. Rev. Respir. Dis.197210568838905032708
     [Google Scholar]
  60. CapellàD. PedrósC. VidalX. LaporteJ.R. Case-population studies in pharmacoepidemiology.Drug Saf.200225171910.2165/00002018‑200225010‑0000211820909
     [Google Scholar]
  61. HerbstA.L. UlfelderH. PoskanzerD.C. Adenocarcinoma of the Vagina.N. Engl. J. Med.19712841687888110.1056/NEJM1971042228416045549830
     [Google Scholar]
  62. AntunesC.M.F. StolleyP.D. RosensheinN.B. DaviesJ.L. TonasciaJ.A. BrownC. BurnettL. RutledgeA. PokempnerM. GarciaR. Endometrial cancer and estrogen use. Report of a large case-control study.N. Engl. J. Med.1979300191310.1056/NEJM197901043000103213722
     [Google Scholar]
  63. LevyM. Aspirin use in patients with major upper gastrointestinal bleeding and peptic-ulcer disease. A report from the Boston Collaborative Drug Surveillance Program, Boston University Medical Center.N. Engl. J. Med.1974290211158116210.1056/NEJM1974052329021024545100
     [Google Scholar]
  64. WeissN.S. SayvetzT.A. Incidence of endometrial cancer in relation to the use of oral contraceptives.N. Engl. J. Med.19803021055155410.1056/NEJM1980030630210047351890
     [Google Scholar]
  65. KaufmanD.W. ShapiroS. SloneD. RosenbergL. MiettinenO.S. StolleyP.D. KnappR.C. LeavittT.Jr WatringW.G. RosensheinN.B. LewisJ.L.Jr SchottenfeldD. EngleR.L.Jr Decreased risk of endometrial cancer among oral-contraceptive users.N. Engl. J. Med.1980303181045104710.1056/NEJM1980103030318077421893
     [Google Scholar]
  66. RosenbergL. ShapiroS. SloneD. KaufmanD.W. HelmrichS.P. MiettinenO.S. StolleyP.D. RosensheinN.B. SchottenfeldD. EngleR.L.Jr Epithelial ovarian cancer and combination oral contraceptives.JAMA1982247233210321210.1001/jama.1982.033204800260207045417
     [Google Scholar]
  67. BeralV. HannafordP. KayC. Oral contraceptive use and malignancies of the genital tract. Results from the Royal College of General Practitioners’ Oral Contraception Study.Lancet198833286241331133510.1016/S0140‑6736(88)90869‑02904052
     [Google Scholar]
  68. SkeggD.C. RichardsS.M. DollR. Minor tranquillisers and road accidents.BMJ19791616891791910.1136/bmj.1.6168.91735267
     [Google Scholar]
  69. RosenbergL. ShapiroS. SloneD. KaufmanD.W. MiettinenO.S. StolleyP.D. Thiazides and acute cholecystitis.N. Engl. J. Med.19803031054654810.1056/NEJM1980090430310027402220
     [Google Scholar]
  70. SloneD. ShapiroS. KaufmanD.W. RosenbergL. MiettinenO.S. StolleyP.D. Risk of myocardial infarction in relation to current and discontinued use of oral contraceptives.N. Engl. J. Med.1981305842042410.1056/NEJM1981082030508027254279
     [Google Scholar]
  71. PumphreyR.S. An Epidemiological Approach to Reducing the Risk of Fatal Anaphylaxis.Anaphylaxis and Hypersensitivity Reactions.Totowa, NJHumana Press2011
     [Google Scholar]
  72. LaporteJ-R. CarnéX. VidalX. MorenoV. JuanJ. Catalan Countries Study on Upper Gastrointestinal Bleeding Upper gastrointestinal bleeding in relation to previous use of analgesics and non-steroidal anti-inflammatory drugs.Lancet19913378733858910.1016/0140‑6736(91)90744‑A1670734
     [Google Scholar]
  73. GraingerJ. WoodmanK. PearceN. CraneJ. BurgessC. KeaneA. BeasleyR. Prescribed fenoterol and death from asthma in New Zealand, 1981-7: a further case-control study.Thorax199146210511110.1136/thx.46.2.1052014490
     [Google Scholar]
  74. FernerR.E. McGettiganP. Adverse drug reactions.BMJ2018363k405110.1136/bmj.k405130401691
     [Google Scholar]
  75. SerugaB. TempletonA.J. BadilloF.E.V. OcanaA. AmirE. TannockI.F. Under-reporting of harm in clinical trials.Lancet Oncol.2016175e209e21910.1016/S1470‑2045(16)00152‑227301048
     [Google Scholar]
  76. HarrisonA. ColvinC.J. KuoC. SwartzA. LurieM. Sustained high HIV incidence in young women in Southern Africa: social, behavioral, and structural factors and emerging intervention approaches.Curr. HIV/AIDS Rep.201512220721510.1007/s11904‑015‑0261‑025855338
     [Google Scholar]
  77. BreskinA. AdimoraA.A. WestreichD. Women and HIV in the United States.PLoS One2017122e017236710.1371/journal.pone.017236728207818
     [Google Scholar]
  78. WatsonS. CasterO. RochonP.A. den RuijterH. Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century.EClinicalMedicine20191710018810.1016/j.eclinm.2019.10.00131891132
     [Google Scholar]
  79. SefahI. Potential Ways to Enhance Adr Reporting Given Current Concerns.Adv. Human Biol.202111213714010.4103/aihb.aihb_41_21
     [Google Scholar]
  80. WatanabeJ.H. McInnisT. HirschJ.D. Cost of prescription drug–related morbidity and mortality.Ann. Pharmacother.201852982983710.1177/106002801876515929577766
     [Google Scholar]
  81. FormicaD. SultanaJ. CutroneoP.M. LucchesiS. AngelicaR. CrisafulliS. IngrasciottaY. SalvoF. SpinaE. TrifiròG. The economic burden of preventable adverse drug reactions: a systematic review of observational studies.Expert Opin. Drug Saf.201817768169510.1080/14740338.2018.149154729952667
     [Google Scholar]
  82. GeorgievK.D. HvarchanovaN. GeorgievaM. KanazirevB. The role of the clinical pharmacist in the prevention of potential drug interactions in geriatric heart failure patients.Int. J. Clin. Pharm.20194161555156110.1007/s11096‑019‑00918‑z31595450
     [Google Scholar]
  83. LeporiniC. De SarroG. RussoE. Adherence to therapy and adverse drug reactions: is there a link?Expert Opin. Drug Saf.201413S14155
     [Google Scholar]
  84. LimandriB.J. Adverse events, drug interactions, and treatment adherence.J. Psychosoc. Nurs. Ment. Health Serv.202058291310.3928/02793695‑20200117‑0232003860
     [Google Scholar]
  85. WHO-UMC.Available from:http://www.who-umc.org/DynPage.aspx?id=100653&mn1=7347&mn2=7252&mn3=7322&mn4=7442(accessed on 12-8-2024)
  86. ADR Monitoring Centres Under PvPI.Available from:http://www.ipc.nic.in/showfile.asp?lid=514&EncHid=(accessed on 12-8-2024)
  87. WHO Global ICSR Database.Available from:http://www.who.umc.org/DynPage.aspx?id=98082&mn1=7347&mn2=7252&mn3=7322&mn4=7326(accessed on 12-8-2024)
  88. Web-Based Individual Case Safety Report.Available from:http://www.who.umc.org/DynPage.aspx?id=97223&mn1=7347&mn2=7252&mn3=7254(accessed on 12-8-2024)
  89. Drugs Safety Alerts of PvPI.Available from:http://www.ipc.nic.in/index2.asp?slid=541&sublinkid=449&lang=1&EncHid=(accessed on 12-8-2024)
  90. ThotaP. ThotaA. MedhiB. SidhuS. KumarP. SelvanV.K. SinghG. Drug safety alerts of pharmacovigilance programme of India: A scope for targeted spontaneous reporting in India.Perspect. Clin. Res.201891515510.4103/picr.PICR_29_1729430420
     [Google Scholar]
  91. HoffmanK.B. DemakasA.R. DimbilM. TatonettiN.P. ErdmanC.B. Stimulated reporting: the impact of US food and drug administration-issued alerts on the adverse event reporting system (FAERS).Drug Saf.2014371197198010.1007/s40264‑014‑0225‑025255848
     [Google Scholar]
  92. HeW. YaoD. HuY. DaiH. Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in China.Ther. Clin. Risk Manag.2018142139214710.2147/TCRM.S17829730464487
     [Google Scholar]
  93. WallerP.C. EvansS.J.W. A model for the future conduct of pharmacovigilance.Pharmacoepidemiol. Drug Saf.2003121172910.1002/pds.77312616844
     [Google Scholar]
  94. 95. European Risk management Strategy: Achievements to date. European Medicines Agency 2007.2007Available from:http://www.emea.europa.eu/pdfs/human/phv/30816707en.pdf(accessed on 12-8-2024)
  95. HärmarkL. van GrootheestA.C. Pharmacovigilance: methods, recent developments and future perspectives.Eur. J. Clin. Pharmacol.200864874375210.1007/s00228‑008‑0475‑918523760
     [Google Scholar]
  96. BorgJ.J. AislaitnerG. PirozynskiM. MifsudS. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.Drug Saf.201134318719710.2165/11586620‑000000000‑0000021332243
     [Google Scholar]
  97. PsatyB.M. BurkeS.P. Protecting the health of the public--Institute of Medicine recommendations on drug safety.N. Engl. J. Med.2006355171753175510.1056/NEJMp06822817030843
     [Google Scholar]
  98. CoombesR. FDA tightens its grip on drug regulation.BMJ2007334758829029110.1136/bmj.39119.546181.5917289729
     [Google Scholar]
  99. HennessyS. StromB.L. PDUFA reauthorization--drug safety’s golden moment of opportunity?N. Engl. J. Med.2007356171703170410.1056/NEJMp07804817435082
     [Google Scholar]
  100. PhuaK.L. AchikeF.I. Vioxx and other pharmaceutical product withdrawals: ethical issues in ensuring the integrity of drug and medical device research, development and commercialization.Clin. Ethics20072315516210.1258/147775007781870029
     [Google Scholar]
  101. LenzW. The History of Thalidomide.Drug News Perspect.1992159604611
     [Google Scholar]
  102. BarkerC.I.S. SnapeM.D. Pandemic influenza A H1N1 vaccines and narcolepsy: vaccine safety surveillance in action.Lancet Infect. Dis.201414322723810.1016/S1473‑3099(13)70238‑X24360892
     [Google Scholar]
  103. MeranteD. CerielloA. Diabetes Drugs.Pharmaceut. Med.201125528529110.1007/BF03256871
     [Google Scholar]
  104. ZmakN. Australian women’s experiences of accessing and using the oral contraceptive pill.Master thesis, Western Sydney University, 2021.
     [Google Scholar]
  105. UhlK. KennedyD.L. KwederS.L. Risk management strategies in the Physicians’ Desk Reference product labels for pregnancy category X drugs.Drug Saf.2002251288589210.2165/00002018‑200225120‑0000612241129
     [Google Scholar]
  106. GreenW. The FDA, contraceptive marketing approval and products liability litigation: Depo-Provera and the risk of osteoporosis.Food Drug Law J.2014682115135
     [Google Scholar]
  107. OrenO. YangE.H. GluckmanT.J. MichosE.D. BlumenthalR.S. GershB.J. Use of chloroquine and hydroxychloroquine in COVID-19 and cardiovascular implications: understanding safety discrepancies to improve interpretation and design of clinical trials.Circ. Arrhythm. Electrophysiol.2020136e00868810.1161/CIRCEP.120.00868832436730
     [Google Scholar]
  108. BouvyJ.C. HuininkL. De BruinM.L. Benefit-risk reassessment of medicines: a retrospective analysis of all safety-related referral procedures in Europe during 2001-2012.Pharmacoepidemiol. Drug Saf.20162591004101410.1002/pds.401127146035
     [Google Scholar]
  109. AbromsL. MaibachE. Lyon-DanielK. FeldmanS.R. What is the best approach to reducing birth defects associated with isotretinoin?PLoS Med.2006311e48310.1371/journal.pmed.003048317121451
     [Google Scholar]
  110. PetersT. SoanesN. AbbasM. AhmadJ. DelumeauJ.C. Herrero-MartinezE. ParamanandaM. PiperJ. Smail-AoudiaF. van der SpuijW. VeizovicT. WinstanleyG. Effective pharmacovigilance system development: EFPIA-IPVG consensus recommendations.Drug Saf.2021441172810.1007/s40264‑020‑01008‑033289904
     [Google Scholar]
  111. AmpaduH.H. HoekmanJ. ArhinfulD. Amoama-DapaahM. LeufkensH.G.M. DodooA.N.O. Organizational capacities of national pharmacovigilance centres in Africa: assessment of resource elements associated with successful and unsuccessful pharmacovigilance experiences.Global. Health201814110910.1186/s12992‑018‑0431‑030445979
     [Google Scholar]
  112. OlssonS. PalS.N. StergachisA. CouperM. Pharmacovigilance activities in 55 low- and middle-income countries: a questionnaire-based analysis.Drug Saf.201033868970310.2165/11536390‑000000000‑0000020635827
     [Google Scholar]
  113. van ManenR.P. FramD. DuMouchelW. Signal detection methodologies to support effective safety management.Expert Opin. Drug Saf.20076445146410.1517/14740338.6.4.45117688389
     [Google Scholar]
  114. Practical aspects of signal detection in pharmacovigilance: report of CIOMS Working Group VIII.ouncil for International Organizations of Medical Sciences2010
     [Google Scholar]
  115. Vallejo-YagüeE. WeilerS. MicheroliR. BurdenA.M. Thromboembolic safety reporting of tofacitinib and baricitinib: an analysis of the WHO VigiBase.Drug Saf.202043988189110.1007/s40264‑020‑00958‑932533433
     [Google Scholar]
  116. HussainR. Big data, medicines safety and pharmacovigilance.J. Pharm. Policy Pract.20211414810.1186/s40545‑021‑00329‑434078480
     [Google Scholar]
  117. LindquistA.M. Seeing and observing in international pharmacovigilance: achievements and prospects in worldwide drug safety.UppsalaUppsala Monitoring Centre2003
     [Google Scholar]
  118. FrankR.A. van der KlaauwN.J. SchiffersteinH.N.J. Both perceptual and conceptual factors influence taste-odor and taste-taste interactions.Percept. Psychophys.199354334335410.3758/BF032052698414893
     [Google Scholar]
  119. BeltonK.J. LewisS.C. PayneS. RawlinsM.D. WoodS.M. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom [see comments].Br. J. Clin. Pharmacol.199539322322610.1111/j.1365‑2125.1995.tb04440.x7619660
     [Google Scholar]
  120. BeltonK.J. The European Pharmacovigilance Research Group Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union.Eur. J. Clin. Pharmacol.199752642342710.1007/s0022800503149342576
     [Google Scholar]
  121. BégaudB. MartinK. HaramburuF. MooreN. Rates of spontaneous reporting of adverse drug reactions in France.JAMA2002288131588158810.1001/jama.288.13.158812350188
     [Google Scholar]
  122. LangmanM.J.S. WeilJ. WainwrightP. LawsonD.H. RawlinsM.D. LoganR.F.A. MurphyM. VesseyM.P. Colin-JonesD.G. Risks of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs.Lancet199434389051075107810.1016/S0140‑6736(94)90185‑67909103
     [Google Scholar]
  123. TrifiròG. CrisafulliS. A new era of pharmacovigilance: Future challenges and opportunities.Frontiers in Drug Safety and Regulation2022286689810.3389/fdsfr.2022.866898
     [Google Scholar]
  124. SuiJ.Y. LiaoS. LiB. ZhangH.F. High sensitivity multitasking non-reciprocity sensor using the photonic spin Hall effect.Opt. Lett.202247236065606810.1364/OL.47604837219173
     [Google Scholar]
/content/journals/cis/10.2174/012210299X326236240821113120
Loading
Promoting Pharmacovigilance: A Review on Significance and Imperative for Establishing Regional Reporting Centres for Adverse Drug Reactions (Adrs)
Curr. Indian Sci. 2, e2210299X326236 (2024); https://doi.org/10.2174/012210299X326236240821113120
/content/journals/cis/10.2174/012210299X326236240821113120
/content/journals/cis/10.2174/012210299X326236240821113120
Loading

Data & Media loading...


  • Article Type:     Review Article
Keyword(s): ADR adverse drug reaction; Drug safety; Pharmacovigilance; PvPI; Regional reporting centers; Sibutramine; Tragedies

Most Cited Most Cited RSS feed

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error
Please enter a valid_number test