Skip to content
2000
Volume 20, Issue 4
  • ISSN: 1574-8863
  • E-ISSN: 2212-3911

Abstract

Pharmacovigilance is an important subject in medicine and healthcare, which aims to prevent side effects and other drug-related problems by identifying, evaluating, understanding, and avoiding them. Its main objectives are ensuring that a drug's benefits balance its hazards and improving patient safety. Within medicine and healthcare, pharmacovigilance is an essential subject that focuses on identifying, evaluating, comprehending, and preventing side effects or any other issues associated with drugs. Its main objective is to improve patient safety and ensure a drug's advantages exceed its drawbacks. Pharmacovigilance has evolved significantly as a result of technological advancements, enabling more efficient medication, safety monitoring, and management. The combination of machine learning (ML) with artificial intelligence (AI) for data analysis, adverse reaction prediction, and signal detection, electronic health records (EHRs), and mobile health (mHealth) applications have enhanced real-time data collecting and expedited the reporting of adverse drug reactions (ADRs). Pharmacovigilance plays an important role which focuses on detecting, assessing, comprehending, and averting adverse medication reactions. Making sure a drug's advantages outweigh its disadvantages is its main objective to improve patient safety. Pharmacovigilance, which balances patient safety, efficacy, and regulatory compliance in clinical trials, is necessary to promote the safe and effective use of drugs.

© 2025 Bentham Science Publishers
Loading

Article metrics loading...

/content/journals/cds/10.2174/0115748863356840250112181406
2025-02-07
2025-09-09

  • From This Site

    /content/journals/cds/10.2174/0115748863356840250112181406
    dcterms_title,dcterms_subject,pub_keyword
    -contentType:Contributor -contentType:Concept -contentType:Institution
    10
    5
Loading full text...

Full text loading...

References

  1. BeningerP. Pharmacovigilance: An Overview.Clin. Ther.201840121991200410.1016/j.clinthera.2018.07.012 30126707
     [Google Scholar]
  2. GomaseV. TagoreS. ChangbhaleS. KaleK. Pharmacogenomics.Curr. Drug Metab.20089320721210.2174/138920008783884830 18336223
     [Google Scholar]
  3. ChoudhuryA. SinghP.A. BajwaN. DashS. BishtP. Pharmacovigilance of herbal medicines: Concerns and future prospects.J. Ethnopharmacol.202330911638310.1016/j.jep.2023.116383 36918049
     [Google Scholar]
  4. KalaiselvanV. ThotaP. SinghG. Pharmacovigilance programme of India: Recent developments and future perspectives.Indian J. Pharmacol.201648662462810.4103/0253‑7613.194855 28066097
     [Google Scholar]
  5. SinghP. VaishnavY. VermaS. Development of pharmacovigilance system in India and paradigm of pharmacovigilance research: An overview.Curr. Drug Saf.202318444846410.2174/1574886317666220930145603 36200243
     [Google Scholar]
  6. PhougatP. BeniwalM. KapoorG. Role and responsibilities of various stakeholders in Pharmacovigilance (PV).Curr. Drug Saf.20241910.2174/0115748863277574240125045459 38318830
     [Google Scholar]
  7. FermontI. Pharmacovigilance strategy: Opportunities for cross-national learning.Isr. J. Health Policy Res.2019815410.1186/s13584‑019‑0319‑3 31217025
     [Google Scholar]
  8. VaseghiG. AbedA. JafariE. EslamiN. EshraghiA. Assessment of adverse drug reaction due to cancer chemotherapy in a teaching oncology hospital in isfahan, central of Iran.Rev. Recent Clin. Trials201611326627210.2174/1574887110666150818112648 26282897
     [Google Scholar]
  9. RodriguesD. SilvestreS. MonteiroC. DuarteA.P. Medication and the risk of falls: An analysis of adverse drug reactions reported to the portuguese pharmacovigilance system.J. Clin. Med.20231223726810.3390/jcm12237268 38068320
     [Google Scholar]
  10. Filippi-ArriagaF. AguileraC. GuillénE. Unknown adverse drug reactions from spontaneous reports in a hospital setting: Characterization, follow-up, and contribution to the pharmacovigilance system.Front. Pharmacol.202314121178610.3389/fphar.2023.1211786 37492089
     [Google Scholar]
  11. EdwardsI.R. An agenda for UK clinical pharmacology: Pharmacovigilance.Br. J. Clin. Pharmacol.201273697998210.1111/j.1365‑2125.2012.04249.x 22360774
     [Google Scholar]
  12. FornasierG. FrancesconS. LeoneR. BaldoP. An historical overview over Pharmacovigilance.Int. J. Clin. Pharm.201840474474710.1007/s11096‑018‑0657‑1 29948743
     [Google Scholar]
  13. WiseL. ParkinsonJ. RaineJ. BreckenridgeA. New approaches to drug safety: A pharmacovigilance tool kit.Nat. Rev. Drug Discov.200981077978210.1038/nrd3002 19763106
     [Google Scholar]
  14. TorreC. CaryM. BorgesF.C. Intensive monitoring studies for assessing medicines: A systematic review.Front. Med. (Lausanne)2019614710.3389/fmed.2019.00147 31380375
     [Google Scholar]
  15. NdagijeH.B. WalusimbiD. AtuhaireJ. AmpaireS. Drug safety in Africa: A review of systems and resources for pharmacovigilance.Expert Opin. Drug Saf.2023221089189510.1080/14740338.2023.2251375 37676033
     [Google Scholar]
  16. LavertuA. VoraB. GiacominiK.M. AltmanR. RensiS. A new era in pharmacovigilance: Toward real‐world data and digital monitoring.Clin. Pharmacol. Ther.202110951197120210.1002/cpt.2172 33492663
     [Google Scholar]
  17. BrownP. BahriP. ‘Engagement’ of patients and healthcare professionals in regulatory pharmacovigilance: Establishing a conceptual and methodological framework.Eur. J. Clin. Pharmacol.20197591181119210.1007/s00228‑019‑02705‑1 31240364
     [Google Scholar]
  18. MwakawangaD.L. KilonziM. PhilipoE.G. Pharmacovigilance and adverse drug reactions reporting: Healthcare providers’ experiences from southern highland Tanzania.Adv. Pharmacol. Pharm. Sci.2023202311010.1155/2023/5537592 37876921
     [Google Scholar]
  19. MontastrucJ.L. Pharmacovigilance and drug safety: Fair prescribing and clinical research.Therapie202277326126310.1016/j.therap.2022.03.001 35581019
     [Google Scholar]
  20. CheaibN. Pharmacovigilance in clinical trials: Current practice and challenges.Account. Res.2016231233010.1080/08989621.2014.956868 26528639
     [Google Scholar]
  21. SorbelloA. HaqueS.A. HasanR. Artificial intelligence–enabled software prototype to inform opioid pharmacovigilance from electronic health records: Development and usability study.JMIR AI20232e4500010.2196/45000 37771410
     [Google Scholar]
  22. DernoncourtA. LiabeufS. BennisY. Fetal and neonatal adverse drug reactions associated with biologics taken during pregnancy by women with autoimmune diseases: Insights from an analysis of the World Health Organization Pharmacovigilance Database (VigiBase®).BioDrugs2023371738710.1007/s40259‑022‑00564‑4 36401769
     [Google Scholar]
  23. TovinoS.A. The HIPAA privacy rule and the EU GDPR: Illustrative comparisons.Seton Hall Law Rev.2017474973993 28820562
     [Google Scholar]
  24. MalikovaM.A. Practical applications of regulatory requirements for signal detection and communications in pharmacovigilance.Ther. Adv. Drug Saf.202011204209862090961410.1177/2042098620909614 32313617
     [Google Scholar]
  25. MarconD.S. QueirozM.R. BaqueroO.S. Adverse event classification and signal detection of data from the customer service and pharmacovigilance of a multinational veterinary pharmaceutical company.Prev. Vet. Med.202220610570410.1016/j.prevetmed.2022.105704 35850073
     [Google Scholar]
  26. ZouM. BarmazY. PreovolosM. PopkoL. MénardT. Using statistical modeling for enhanced and flexible pharmacovigilance audit risk assessment and planning.Ther. Innov. Regul. Sci.202155119019610.1007/s43441‑020‑00205‑4 32804381
     [Google Scholar]
  27. DiasP. PenedonesA. AlvesC. RibeiroC. MarquesF. The role of disproportionality analysis of pharmacovigilance databases in safety regulatory actions: A systematic review.Curr. Drug Saf.201510323425010.2174/1574886310666150729112903 26219291
     [Google Scholar]
  28. PharmacovigilanceG.L. UseA.D. Healthcare (Basel)202412666910.3390/healthcare12060669 38540633
     [Google Scholar]
  29. LucasS. AilaniJ. SmithT.R. AbdrabbohA. XueF. NavettaM.S. Pharmacovigilance: Reporting requirements throughout a product’s lifecycle.Ther. Adv. Drug Saf.2022132042098622112500610.1177/20420986221125006 36187302
     [Google Scholar]
  30. BihanK. Lebrun-VignesB. Funck-BrentanoC. SalemJ.E. Uses of pharmacovigilance databases: An overview.Therapie202075659159810.1016/j.therap.2020.02.022 32169289
     [Google Scholar]
  31. BalceracA. BaldacciA. RomierA. Drug-induced delusion: A comprehensive overview of the WHO pharmacovigilance database.Psychiatry Res.202332711536510.1016/j.psychres.2023.115365 37517106
     [Google Scholar]
  32. EsslingerS. QuinnL. SampatS. Risk Management Plans: reassessment of safety concerns based on Good Pharmacovigilance Practices Module V (Revision 2)—a company experience.J. Pharm. Health Care Sci.2022811410.1186/s40780‑022‑00244‑z 35509028
     [Google Scholar]
  33. TsintisP. La MacheE. CIOMS and ICH initiatives in pharmacovigilance and risk management: Overview and implications.Drug Saf.200427850951710.2165/00002018‑200427080‑00004 15154824
     [Google Scholar]
  34. KohamaM. NonakaT. UyamaY. IshiguroC. Descriptive analysis for the trend of pharmacovigilance planning in risk management plans on new drugs approved during 2016–2019.Ther. Innov. Regul. Sci.2023571374710.1007/s43441‑022‑00437‑6 35963930
     [Google Scholar]
  35. MontastrucJ.L. Guion-FirminJ. de CanecaudeC. Drugs and Dupuytren’s disease: A pharmacovigilance study in VigiBase®.Eur. J. Clin. Pharmacol.202177101587158810.1007/s00228‑021‑03139‑4 33914107
     [Google Scholar]
  36. Rayón-RamírezG. Alvarado-LópezS. Camacho-SandovalR. LoeraM.J. SvarchA.E. Alcocer-VarelaJ. Strengthening the pharmacovigilance system in Mexico: Implementation of VigiFlow and VigiLyze, as ICSR and signal detection management systems.Pharmaceut. Med.202337642543710.1007/s40290‑023‑00490‑y 37804414
     [Google Scholar]
  37. KalaiselvanV. SrivastavaS. SinghA. GuptaS.K. Pharmacovigilance in India: Present scenario and future challenges.Drug Saf.201942333934610.1007/s40264‑018‑0730‑7 30269244
     [Google Scholar]
  38. LengsavathM. Dal PraA. de FerranA.M. Social media monitoring and adverse drug reaction reporting in pharmacovigilance: An overview of the regulatory landscape.Ther. Innov. Regul. Sci.201751112513110.1177/2168479016663264 30235992
     [Google Scholar]
  39. XieY.M. TianF. Interpretation of guidelines on good pharmacovigilance practices for European Union.Zhongguo Zhongyao Zazhi2013381829632968 24471312
     [Google Scholar]
  40. DestereA. MerinoD. LavrutT. Drug-induced cardiac toxicity and adverse drug reactions, a narrative review.Therapie202479216117210.1016/j.therap.2023.10.008 37957054
     [Google Scholar]
  41. GreavesL. BrabeteA.C. MaximosM. Sex, gender, and the regulation of prescription drugs: Omissions and opportunities.Int. J. Environ. Res. Public Health2023204296210.3390/ijerph20042962 36833654
     [Google Scholar]
  42. KalaivaniM. SinghA. KalaiselvanV. Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India.MAbs20157127628010.4161/19420862.2014.985547 25523367
     [Google Scholar]
  43. PrakashJ. SachdevaR. ShrivastavaT. JayachandranC.V. SahuA. Adverse event reporting tools and regulatory measures in India through outcome of Pharmacovigilance Programme of India.Indian J. Pharmacol.202153214315210.4103/ijp.ijp_901_20 34100398
     [Google Scholar]
  44. Contreras-SalinasH. Baiza-DuránL.M. Bautista-CastroM.A. Alonso-RodríguezD.R. Rodríguez-HerreraL.Y. Underreporting and triggering factors for reporting ADRs of two ophthalmic drugs: A comparison between spontaneous reports and active pharmacovigilance databases.Healthcare (Basel)20221011218210.3390/healthcare10112182 36360523
     [Google Scholar]
  45. SteurbautS. HanssensY. Pharmacovigilance: Empowering healthcare professionals and patients.Int. J. Clin. Pharm.201436585986210.1007/s11096‑014‑0004‑0 25190178
     [Google Scholar]
  46. LedieuT. BouzilléG. ThiessardF. Timeline representation of clinical data: usability and added value for pharmacovigilance.BMC Med. Inform. Decis. Mak.20181818610.1186/s12911‑018‑0667‑x 30340483
     [Google Scholar]
  47. KigubaR. IsabiryeG. MayengoJ. Navigating duplication in pharmacovigilance databases: A scoping review.BMJ Open2024144e08199010.1136/bmjopen‑2023‑081990 38684275
     [Google Scholar]
  48. LindquistM. Data quality management in pharmacovigilance.Drug Saf.2004271285787010.2165/00002018‑200427120‑00003 15366974
     [Google Scholar]
  49. ThotaP. ThotaA. MedhiB. Drug safety alerts of pharmacovigilance programme of India: A scope for targeted spontaneous reporting in India.Perspect. Clin. Res.201891515510.4103/picr.PICR_29_17 29430420
     [Google Scholar]
  50. HaubenM. Artificial intelligence and data mining for the pharmacovigilance of drug–drug interactions.Clin. Ther.202345211713310.1016/j.clinthera.2023.01.002 36732152
     [Google Scholar]
  51. CrestanD. TrojniakM.P. FrancesconS. FornasierG. BaldoP. Pharmacovigilance of anti-cancer medicines: Opportunities and challenges.Expert Opin. Drug Saf.202019784986010.1080/14740338.2020.1772751 32552095
     [Google Scholar]
  52. LedieuT. BouzilléG. PolardE. PlaisantC. ThiessardF. CuggiaM. Clinical data analytics with time-related graphical user interfaces: Application to pharmacovigilance.Front. Pharmacol.2018971710.3389/fphar.2018.00717 30233354
     [Google Scholar]
  53. HussainS. DanielC. YukselM. Bridging data models and terminologies to support adverse drug event reporting using EHR data.Methods Inf. Med.2015541243110.3414/ME13‑02‑0025 25487120
     [Google Scholar]
  54. BöhmR. von HehnL. HerdegenT. OpenVigil FDA – inspection of U.S. American adverse drug events pharmacovigilance data and novel clinical applications.PLoS One2016116e015775310.1371/journal.pone.0157753 27326858
     [Google Scholar]
  55. SimmsA.M. KanakiaA. SipraM. DuttaB. SouthallN. A patient safety knowledge graph supporting vaccine product development.BMC Med. Inform. Decis. Mak.20242411010.1186/s12911‑023‑02409‑8 38178113
     [Google Scholar]
  56. SatwikaM.V. SushmaD.S. JaiswalV. AshaS. PalT. The role of advanced technologies supplemented with traditional methods in pharmacovigilance sciences.Recent Pat. Biotechnol.2021151345010.2174/1872208314666201021162704 33087036
     [Google Scholar]
  57. ShinH. LeeS. An OMOP-CDM based pharmacovigilance data-processing pipeline (PDP) providing active surveillance for ADR signal detection from real-world data sources.BMC Med. Inform. Decis. Mak.202121115910.1186/s12911‑021‑01520‑y 34001114
     [Google Scholar]
  58. DavisS.E. ZabotkaL. DesaiR.J. Use of electronic health record data for drug safety signal identification: A scoping review.Drug Saf.202346872574210.1007/s40264‑023‑01325‑0 37340238
     [Google Scholar]
  59. LiangL. HuJ. SunG. Artificial intelligence-based pharmacovigilance in the setting of limited resources.Drug Saf.202245551151910.1007/s40264‑022‑01170‑7 35579814
     [Google Scholar]
  60. SalasM. PetracekJ. YalamanchiliP. The use of artificial intelligence in pharmacovigilance: A systematic review of the literature.Pharmaceut. Med.202236529530610.1007/s40290‑022‑00441‑z 35904529
     [Google Scholar]
  61. BhardwajK. AlamR. PandeyaA. SharmaP.K. Artificial intelligence in pharmacovigilance and COVID-19.Curr. Drug Saf.202318151410.2174/1574886317666220405115548 35382726
     [Google Scholar]
  62. AronsonJ.K. Artificial intelligence in pharmacovigilance: An introduction to terms, concepts, applications, and limitations.Drug Saf.202245540741810.1007/s40264‑022‑01156‑5 35579806
     [Google Scholar]
  63. MedhiB. MuraliK. KaurS. PrakashA. Artificial intelligence in pharmacovigilance: Practical utility.Indian J. Pharmacol.201951637337610.4103/ijp.IJP_814_19 32029958
     [Google Scholar]
  64. SharifK. OmarM. LahatA. Big data- and machine learning-based analysis of a global pharmacovigilance database enables the discovery of sex-specific differences in the safety profile of dual IL4/IL13 blockade.Front. Pharmacol.202314127130910.3389/fphar.2023.1271309 37954855
     [Google Scholar]
  65. TrifiròG. SultanaJ. BateA. From big data to smart data for pharmacovigilance: The role of healthcare databases and other emerging sources.Drug Saf.201841214314910.1007/s40264‑017‑0592‑4 28840504
     [Google Scholar]
  66. BouzilléG. MorivalC. WesterlynckR. An automated detection system of drug-drug interactions from electronic patient records using big data analytics.Stud. Health Technol. Inform.2019264454910.3233/SHTI190180 31437882
     [Google Scholar]
  67. StevensonJ.G. GreenL. Biologics, pharmacovigilance, and patient safety: It’s all in the name.J. Manag. Care Spec. Pharm.201622892793010.18553/jmcp.2016.22.8.927 27459655
     [Google Scholar]
  68. Tavakoli-ArdakaniM. OmidiS. EshraghiA. SalamzadehJ. Medication errors in administration of chemotherapeutic agents: An observational study.Indian J. Pharm. Sci.201392111
     [Google Scholar]
  69. AbbasinazariM. Hajhossein TalasazA. EshraghiA. SahraeiZ. Detection and management of medication errors in internal wards of a teaching hospital by clinical pharmacists.Acta Med. Iran.2013517482486 23945894
     [Google Scholar]
  70. PittsP.J. Le LouetH. Advancing drug safety through prospective pharmacovigilance.Ther. Innov. Regul. Sci.201852440040210.1177/2168479018766887 29714580
     [Google Scholar]
  71. AlomarM. TawfiqA.M. HassanN. PalaianS. Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: Current status, challenges and the future.Ther. Adv. Drug Saf.202011204209862093859510.1177/2042098620938595 32843958
     [Google Scholar]
  72. HärmarkL. RaineJ. LeufkensH. Patient-reported safety information: A renaissance of pharmacovigilance?Drug Saf.2016391088389010.1007/s40264‑016‑0441‑x 27379887
     [Google Scholar]
  73. BirdS.M. Study‐design in pandemics: From surveillance and performance‐evaluation to licensing and pharmacovigilance.Pharm. Stat.202221476477710.1002/pst.2217 35819118
     [Google Scholar]
  74. RolfesL. van HunselF. van GrootheestK. van PuijenbroekE. Feedback for patients reporting adverse drug reactions; satisfaction and expectations.Expert Opin. Drug Saf.201514562563210.1517/14740338.2015.1021775 25766456
     [Google Scholar]
  75. HarveyRD Science of biosimilarsJ Oncol Pract2017139_suppl)(Suppl.17s23s10.1200/JOP.2017.026062 28898589
     [Google Scholar]
  76. PittsP.J. LouetH.L. MorideY. ContiR.M. 21st century pharmacovigilance: Efforts, roles, and responsibilities.Lancet Oncol.20161711e486e49210.1016/S1470‑2045(16)30312‑6 27819246
     [Google Scholar]
  77. LanglitzN. Pharmacovigilance and post-black market surveillance.Soc. Stud. Sci.200939339542010.1177/0306312708101977 19848184
     [Google Scholar]
  78. KingstonR. SiorisK. GualtieriJ. BrutlagA. DroegeW. OsimitzT.G. Post-market surveillance of consumer products: Framework for adverse event management.Regul. Toxicol. Pharmacol.202112610502810.1016/j.yrtph.2021.105028 34481892
     [Google Scholar]
  79. van den OuwelandF. CharpentierN. TüreciÖ. Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data.Hum. Vaccin. Immunother.2024201231565910.1080/21645515.2024.2315659 38407186
     [Google Scholar]
  80. BateA. BeckmannJ. DodooA. Developing a crowdsourcing approach and tool for pharmacovigilance education material delivery.Drug Saf.201740319119910.1007/s40264‑016‑0495‑9 28101815
     [Google Scholar]
  81. ShenoyA.K. KamathA. ChowtaM.N. Knowledge of pharmacovigilance among healthcare professionals and the impact of an educational intervention.Med. Pharm. Rep.202396440641210.15386/mpr‑2076 37970197
     [Google Scholar]
  82. ComoglioR.H. Undergraduate and postgraduate pharmacovigilance education: A proposal for appropriate curriculum content.Br. J. Clin. Pharmacol.202086477979010.1111/bcp.14179 31770452
     [Google Scholar]
  83. BahriP. Public pharmacovigilance communication: A process calling for evidence-based, objective-driven strategies.Drug Saf.201033121065107910.2165/11539040‑000000000‑00000 21077698
     [Google Scholar]
  84. BeningerP. Signal management in pharmacovigilance: A review of activities and case studies.Clin. Ther.20204261110112910.1016/j.clinthera.2020.03.018 32487428
     [Google Scholar]
  85. CobertB. SilveyJ. The Internet and drug safety: What are the implications for pharmacovigilance?Drug Saf.19992029510710.2165/00002018‑199920020‑00001 10082068
     [Google Scholar]
  86. BerrewaertsJ. DelbecqueL. OrbanP. DesseillesM. Patient participation and the use of ehealth tools for pharmacoviligance.Front. Pharmacol.201679010.3389/fphar.2016.00090 27148052
     [Google Scholar]
  87. LiuF. JagannathaA. YuH. Towards drug safety surveillance and pharmacovigilance: Current progress in detecting medication and adverse drug events from electronic health records.Drug Saf.2019421959710.1007/s40264‑018‑0766‑8 30649734
     [Google Scholar]
  88. ShuklaA.K. JhajR. MisraS. AhmedS.N. NandaM. ChaudharyD. Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions.J. Family Med. Prim. Care20211093303330810.4103/jfmpc.jfmpc_831_21 34760748
     [Google Scholar]
  89. HelfertS. Historical aspects of immunization and vaccine safety communication.Curr. Drug Saf.20151015810.2174/157488631001150407103723 25859668
     [Google Scholar]
  90. AriciM.A. GelalA. DemiralY. TuncokY. Short and long-term impact of pharmacovigilance training on the pharmacovigilance knowledge of medical students.Indian J. Pharmacol.201547443643910.4103/0253‑7613.161272 26288478
     [Google Scholar]
  91. BaldoP. FrancesconS. FornasierG. Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology.Int. J. Clin. Pharm.201840474875310.1007/s11096‑018‑0711‑z 30094557
     [Google Scholar]
  92. ZuñigaL. CalvoB. Biosimilars: Pharmacovigilance and risk management.Pharmacoepidemiol. Drug Saf.201019766166910.1002/pds.1948 20583204
     [Google Scholar]
  93. FernandesS.D. AnoopN.V. CastelinoL.J. CharyuluR.N. A national approach to pharmacovigilance: The case of India as a growing hub of global clinical trials.Res. Social Adm. Pharm.201915110911310.1016/j.sapharm.2018.03.061 29602659
     [Google Scholar]
  94. MukherjeeS. MaitiR. Haemovigilance: A current update in Indian perspective.J. Clin. Diagn. Res.20161011EE05EE0910.7860/JCDR/2016/21029.8868 28050389
     [Google Scholar]
  95. SudhaR. GoelI. KatiyarP. Haemovigilance in India during the COVID-19 pandemic.J. Glob. Health2023130303010.7189/jogh.13.03030 37733601
     [Google Scholar]
  96. SanghaviD. Regulatory reforms in India.Ther. Innov. Regul. Sci.2013471161810.1177/2168479012470650 30227478
     [Google Scholar]
  97. RehanH.S. ChopraD. HolaniS.N. MishraR. An observational study to compare the contents and quality of information furnished in CDSCO ADR reporting form, yellow card, medwatch and blue form by the healthcare professionals.Int. J. Risk Saf. Med.20142611810.3233/JRS‑140608 24796346
     [Google Scholar]
  98. NelsonR.C. PalsulichB. GogolakV. Good pharmacovigilance practices: Technology enabled.Drug Saf.200225640741410.2165/00002018‑200225060‑00004 12071777
     [Google Scholar]
  99. BaldoP. De PaoliP. Pharmacovigilance in oncology: Evaluation of current practice and future perspectives.J. Eval. Clin. Pract.201420555956910.1111/jep.12184 24909067
     [Google Scholar]
  100. SalathéM. Digital pharmacovigilance and disease surveillance: Combining traditional and big-data systems for better public health.J. Infect. Dis.2016214Suppl. 4S399S40310.1093/infdis/jiw281 28830106
     [Google Scholar]
  101. YuY.B. BriggsK.T. TarabanM.B. Preventive Pharmacovigilance: Timely and precise prevention of adverse events through person-level patient screening and dose-level product surveillance.Pharm. Res.20234092103210610.1007/s11095‑023‑03548‑3 37349651
     [Google Scholar]
  102. KumarA. Pharmacovigilance: Importance, concepts, and processes.Am. J. Health Syst. Pharm.201774860661210.2146/ajhp151031 28235869
     [Google Scholar]
  103. AgustíA. CerezaG. de AbajoF.J. MaciáM.A. SacristánJ.A. Clinical pharmacology facing the real-world setting: Pharmacovigilance, pharmacoepidemiology and the economic evaluation of drugs.Pharmacol. Res.202319710696710.1016/j.phrs.2023.106967 37865127
     [Google Scholar]
  104. KhanZ. KaratasY. HamidS.M. Evaluation of health care professionals’ knowledge, attitudes, practices and barriers to pharmacovigilance and adverse drug reaction reporting: A cross-sectional multicentral study.PLoS One2023185e028581110.1371/journal.pone.0285811 37224133
     [Google Scholar]
  105. KantA.C. Appeal for increasing the impact of pharmacovigilance.Drug Saf.202447211311610.1007/s40264‑023‑01375‑4 38114758
     [Google Scholar]
  106. ClausB. Is pharmacovigilance of biologicals cost-effective?Int. J. Clin. Pharm.201840478778910.1007/s11096‑018‑0695‑8 30051230
     [Google Scholar]
  107. MartinL.G. HanssensY. PaudyalV. Overview of this issue: Pharmacovigilance, what is new?Int. J. Clin. Pharm.201840473773910.1007/s11096‑018‑0719‑4 30132234
     [Google Scholar]
  108. InácioP. CavacoA. AiraksinenM. The value of patient reporting to the pharmacovigilance system: A systematic review.Br. J. Clin. Pharmacol.201783222724610.1111/bcp.13098 27558545
     [Google Scholar]
  109. SamaraC. GarciaA. HenryC. Safety surveillance during drug development: Comparative evaluation of existing regulations.Adv. Ther.20234052147218510.1007/s12325‑023‑02492‑3 37020083
     [Google Scholar]
  110. EdwardsI.R. LindquistM. The issues of individualized medicine and pharmacovigilance: A consideration of COVID-19 and vaccination.Int. J. Risk Saf. Med.202031417918010.3233/JRS‑201008 33164947
     [Google Scholar]
  111. YadavL. MehraP. VasisthD. MattuN. BiswasK. YadavN. Assessment of knowledge, attitude, and practice of pharmacovigilance and materiovigilance among oral health practitioners in India.J. Pharm. Bioallied Sci.202416Suppl. 1S202S20510.4103/jpbs.jpbs_456_23 38595538
     [Google Scholar]
  112. BordetC. GarciaP. SalvoF. Antipsychotics and risk of QT prolongation: A pharmacovigilance study.Psychopharmacology (Berl.)2023240119920210.1007/s00213‑022‑06293‑4 36515735
     [Google Scholar]
  113. SugayJ. Clinical Trials: Nursing roles during the approval process and pharmacovigilance of biosimilars.Clin. J. Oncol. Nurs.2018225273210.1188/18.CJON.S1.27‑32 30239528
     [Google Scholar]
  114. LiangX. XiaoH. LiH. ChenX. LiY. Adverse events associated with immune checkpoint inhibitors in non-small cell lung cancer: A safety analysis of clinical trials and FDA pharmacovigilance system.Front. Immunol.202415139675210.3389/fimmu.2024.1396752 38745663
     [Google Scholar]
  115. WangD.Y. SalemJ.E. CohenJ.V. Fatal toxic effects associated with immune checkpoint inhibitors.JAMA Oncol.20184121721172810.1001/jamaoncol.2018.3923 30242316
     [Google Scholar]
  116. MaigetterK. PollockA.M. KadamA. WardK. WeissM.G. Pharmacovigilance in India, Uganda and South Africa with reference to WHO’s minimum requirements.Int. J. Health Policy Manag.20154529530510.15171/ijhpm.2015.55 25905480
     [Google Scholar]
  117. GarashiH.Y. SteinkeD.T. SchafheutleE.I. A systematic review of pharmacovigilance systems in developing countries using the WHO pharmacovigilance indicators.Ther. Innov. Regul. Sci.202256571774310.1007/s43441‑022‑00415‑y 35657484
     [Google Scholar]
  118. SeeM. ButcherB.E. BanhA. Patient literacy and awareness of medicine safety.Int. J. Pharm. Pract.202028655256010.1111/ijpp.12671 32931060
     [Google Scholar]
  119. van HoofM. ChinchillaK. HärmarkL. MatosC. InácioP. van HunselF. Factors contributing to best practices for patient involvement in pharmacovigilance in Europe: A stakeholder analysis.Drug Saf.202245101083109810.1007/s40264‑022‑01222‑y 36008634
     [Google Scholar]
  120. KhooY.K. LimJ.C.W. Tan-KoiW.C. KitikitiN.S. Sim-DevadasA.L. Promoting collaboration of regulators and patients in improving drug safety and regulatory decision making.Drug Saf.202447321722510.1007/s40264‑023‑01385‑2 38082120
     [Google Scholar]
  121. RadeckaA. LoughlinL. FoyM. Enhancing pharmacovigilance capabilities in the EU regulatory network: The SCOPE joint action.Drug Saf.201841121285130210.1007/s40264‑018‑0708‑5 30128638
     [Google Scholar]
  122. SalehiT. SeyedfatemiN. MirzaeeM.S. MalekiM. MardaniA. Nurses’ knowledge, attitudes, and practice in relation to pharmacovigilance and adverse drug reaction reporting: A systematic review.BioMed Res. Int.2021202111210.1155/2021/6630404 33937402
     [Google Scholar]
  123. KhanZ. KaratasY. MartinsM.A.P. JamshedS. RahmanH. Knowledge, attitude, practice and barriers towards pharmacovigilance and adverse drug reactions reporting among healthcare professionals in Turkey: A systematic review.Curr. Med. Res. Opin.202238114515410.1080/03007995.2021.1997287 34694167
     [Google Scholar]
  124. AlwhaibiM. Al AloolaN.A. Healthcare students’ knowledge, attitude and perception of pharmacovigilance: A systematic review.PLoS One2020155e023339310.1371/journal.pone.0233393 32433649
     [Google Scholar]
  125. HegdeM. RajS. TikadarD. NyamagoudS.B. Unveiling vaccine safety: A narrative review of pharmacovigilance in India’s COVID-19 vaccination.Monaldi Arch. Chest Dis.202310.4081/monaldi.2023.2793 38037892
     [Google Scholar]
  126. DashS. SinghP.A. BajwaN. ChoudhuryA. BishtP. SharmaR. Why pharmacovigilance of non-steroidal anti-inflammatory drugs is important in India?Endocr. Metab. Immune Disord. Drug Targets202424773174810.2174/0118715303247469230926092404 37855282
     [Google Scholar]
  127. LihiteR.J. LahkarM. An update on the Pharmacovigilance Programme of India.Front. Pharmacol.2015619410.3389/fphar.2015.00194 26441651
     [Google Scholar]
  128. ThotaP. AgrawalV. ShrivastavaT.P. AdusumilliP.K. VivekanandanK. BhushanS. Pivotal role of Pharmacovigilance Programme of India in containment of antimicrobial resistance in India.Perspect. Clin. Res.201910314014410.4103/picr.PICR_29_18 31404182
     [Google Scholar]
  129. JoseJ. RafeekN.R. Pharmacovigilance in India in Comparison With the USA and European Union: Challenges and Perspectives.Ther. Innov. Regul. Sci.201953678178610.1177/2168479018812775 30554527
     [Google Scholar]
  130. TandonV. MahajanV. KhajuriaV. GillaniZ. Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India.Indian J. Pharmacol.2015471657110.4103/0253‑7613.150344 25821314
     [Google Scholar]
  131. KaurI. KumarP. KalaiselvanV. SinghA. Safety monitoring of local anaesthetic drugs from the perspective of Pharmacovigilance Programme of India.Indian J. Anaesth.201761753453710.4103/ija.IJA_418_17 28794523
     [Google Scholar]
  132. BarbosaL.H.L.A. SilvaA.R.O. Carvalho-AssefA.P.D.A. LimaE.C. da SilvaF.A.B. Potential safety signals for antibacterial agents from the Brazilian national pharmacovigilance database (Vigimed/VigiFlow).Front. Pharmacol.20221394833910.3389/fphar.2022.948339 36204235
     [Google Scholar]
  133. SandesV. FiguerasA. LimaE.C. Pharmacovigilance strategies to address resistance to antibiotics and inappropriate use—a narrative review.Antibiotics (Basel)202413545710.3390/antibiotics13050457 38786184
     [Google Scholar]
  134. BairyL.K. NayakV. AA KunderS.K. Advances in pharmacovigilance initiatives surrounding antimicrobial resistance-Indian perspective.Expert Opin. Drug Saf.20161581055106210.1080/14740338.2016.1182495 27142491
     [Google Scholar]
  135. AgrawalM. SinghP. HishikarR. JoshiU. MaheshwariB. HalwaiA. Adverse drug reactions at adverse drug reaction monitoring center in Raipur: Analysis of spontaneous reports during 1 year.Indian J. Pharmacol.201749643243710.4103/ijp.IJP_781_16 29674797
     [Google Scholar]
  136. PanneerselvamN. KathirveluP. ManoharanR. Impact of educational intervention on the knowledge, attitude, and practice of pharmacovigilance among postgraduates of a tertiary care center, Kanchipuram, Tamil Nadu, India.Perspect. Clin. Res.202213419920410.4103/picr.PICR_239_20 36337373
     [Google Scholar]
  137. SharmaM. BaghelR. ThakurS. AdwalS. Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: A 7-year surveillance study.BMJ Open20211110e05273710.1136/bmjopen‑2021‑052737 34607871
     [Google Scholar]
  138. ThakareV. PatilA. JainM. RaiV. LangadeD. Adverse drug reactions reporting: Five years analysis from a teaching hospital.J. Family Med. Prim. Care202211117316732110.4103/jfmpc.jfmpc_1043_22 36993081
     [Google Scholar]
  139. MillerV. NwokikeJ. StergachisA. Pharmacovigilance and global HIV/AIDS.Curr. Opin. HIV AIDS20127429930410.1097/COH.0b013e328354d8e7 22627711
     [Google Scholar]
  140. BeningerP. IbaraM.A. Pharmacovigilance and biomedical informatics: A model for future development.Clin. Ther.201638122514252510.1016/j.clinthera.2016.11.006 27913029
     [Google Scholar]
  141. KhanM.A.A. HamidS. BabarZ.U.D. Pharmacovigilance in high-income countries: Current developments and a review of literature.Pharmacy (Basel)20231111010.3390/pharmacy11010010 36649020
     [Google Scholar]
  142. PostigoR. BroschS. SlatteryJ. EudraVigilance medicines safety database: Publicly accessible data for research and public health protection.Drug Saf.201841766567510.1007/s40264‑018‑0647‑1 29520645
     [Google Scholar]
  143. ZuberPLF GruberM KaslowDC ChenRT GiersingBK FriedeMH Evolving pharmacovigilance requirements with novel vaccines and vaccine components.BMJ Glob Health20216Suppl. 2e00340310.1136/bmjgh‑2020‑003403 34011500
     [Google Scholar]
  144. InokumaY. KnellerR. Imprecision in vaccine adverse event reporting and a methodological analysis of reporting systems to improve pharmacovigilance and public health.Eur. J. Clin. Pharmacol.2023797989100210.1007/s00228‑023‑03505‑4 37249640
     [Google Scholar]
  145. PutriR.A. IkawatiZ. RahmawatiF. YasinN.M. An awareness of pharmacovigilance among healthcare professionals due to an underreporting of adverse drug reactions issue: A systematic review of the current state, obstacles, and strategy.Curr. Drug Saf.202419331733110.2174/0115748863276456231016062628 38989832
     [Google Scholar]
  146. Seselja PerisinA. BukicJ. RusicD. Teaching pharmacovigilance to healthcare students: Identifying gaps and opportunities for improvement.Pharmacy (Basel)20219314710.3390/pharmacy9030147 34449747
     [Google Scholar]
  147. EdreesH. SongW. SyrowatkaA. SimonaA. AmatoM.G. BatesD.W. Intelligent telehealth in pharmacovigilance: A future perspective.Drug Saf.202245544945810.1007/s40264‑022‑01172‑5 35579810
     [Google Scholar]
  148. GünerM.D. EkmekciP.E. Healthcare professionals’ pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates.J. Drug Assess.201981132010.1080/21556660.2019.1566137 30729064
     [Google Scholar]
  149. HodelK.V.S. FiuzaB.S.D. ConceiçãoR.S. Pharmacovigilance in vaccines: Importance, main aspects, perspectives, and challenges—a narrative review.Pharmaceuticals (Basel)202417680710.3390/ph17060807 38931474
     [Google Scholar]
  150. FerraraF. MancanielloC. VarrialeA. COVID-19 mRNA vaccines: A retrospective observational pharmacovigilance study.Clin. Drug Investig.202242121065107410.1007/s40261‑022‑01216‑9 36274082
     [Google Scholar]
  151. LaiE.C.C. PrattN. HsiehC.Y. Sequence symmetry analysis in pharmacovigilance and pharmacoepidemiologic studies.Eur. J. Epidemiol.201732756758210.1007/s10654‑017‑0281‑8 28698923
     [Google Scholar]
  152. BrandK.M.G. SchlachterJ. FochC. BoutmyE. Quality and characteristics of 4241 case reports of lactic acidosis in metformin users reported to a large pharmacovigilance database.Ther. Clin. Risk Manag.2022181037104710.2147/TCRM.S372430 36389204
     [Google Scholar]
  153. DalanD. Clinical data mining and research in the allergy office.Curr. Opin. Allergy Clin. Immunol.201010317117710.1097/ACI.0b013e328337bce6 20179584
     [Google Scholar]
  154. CostaB. FigueiredoB. PinheiroV. Validation rules as a first step for data quality: Pharmacovigilance application in Portugal.Stud. Health Technol. Inform.202330238238310.3233/SHTI230151 37203696
     [Google Scholar]
  155. NieX. ZhangY. WuZ. Evaluation of reporting quality for observational studies using routinely collected health data in pharmacovigilance.Expert Opin. Drug Saf.201817766166810.1080/14740338.2018.1484106 29857774
     [Google Scholar]
  156. BasileA.O. YahiA. TatonettiN.P. Artificial intelligence for drug toxicity and safety.Trends Pharmacol. Sci.201940962463510.1016/j.tips.2019.07.005 31383376
     [Google Scholar]
  157. LinS. LeiS. LiuW. Global trends in pharmacovigilance-related events: A 30-year analysis from the 2019 global burden of disease study.Int. J. Clin. Pharm.20244651076109010.1007/s11096‑024‑01738‑6 38727779
     [Google Scholar]
  158. SalvoF. MicallefJ. LahouegueA. Will the future of pharmacovigilance be more automated?Expert Opin. Drug Saf.202322754154810.1080/14740338.2023.2227091 37435796
     [Google Scholar]
  159. BallR. Dal PanG. “Artificial Intelligence” for Pharmacovigilance: Ready for Prime Time?Drug Saf.202245542943810.1007/s40264‑022‑01157‑4 35579808
     [Google Scholar]
  160. MockuteR DesaiS PereraS Artificial intelligence within pharmacovigilance: A means to identify cognitive services and the framework for their validation.Pharmaceut Med201933210912010.1007/s40290‑019‑00269‑0 31933254
     [Google Scholar]
  161. Gonzalez-HernandezG. KrallingerM. MuñozM. Rodriguez-EstebanR. UzunerÖ. HirschmanL. Challenges and opportunities for mining adverse drug reactions: Perspectives from pharma, regulatory agencies, healthcare providers and consumers.Database (Oxford)20222022baac07110.1093/database/baac071 36050787
     [Google Scholar]
  162. De Abreu FerreiraR. ZhongS. MoureaudC. A pilot, predictive surveillance model in pharmacovigilance using machine learning approaches.Adv. Ther.20244162435244510.1007/s12325‑024‑02870‑5 38704799
     [Google Scholar]
  163. HaubenM. Artificial intelligence in pharmacovigilance: Do we need explainability?Pharmacoepidemiol. Drug Saf.202231121311131610.1002/pds.5501 35747938
     [Google Scholar]
  164. PinheiroL.C. KurzX. Artificial intelligence in pharmacovigilance: A regulatory perspective on explainability.Pharmacoepidemiol. Drug Saf.202231121308131010.1002/pds.5524 35959980
     [Google Scholar]
  165. MartinG.L. JouganousJ. SavidanR. Validation of artificial intelligence to support the automatic coding of patient adverse drug reaction reports, using nationwide pharmacovigilance data.Drug Saf.202245553554810.1007/s40264‑022‑01153‑8 35579816
     [Google Scholar]
  166. SchmiderJ. KumarK. LaForestC. SwankoskiB. NaimK. CaubelP.M. Innovation in pharmacovigilance: Use of artificial intelligence in adverse event case processing.Clin. Pharmacol. Ther.2019105495496110.1002/cpt.1255 30303528
     [Google Scholar]
  167. BateA. LuoY. Artificial intelligence and machine learning for safe medicines.Drug Saf.202245540340510.1007/s40264‑022‑01177‑0 35579805
     [Google Scholar]
  168. KompaB. HakimJ.B. PalepuA. Artificial intelligence based on machine learning in pharmacovigilance: A scoping review.Drug Saf.202245547749110.1007/s40264‑022‑01176‑1 35579812
     [Google Scholar]
  169. KassekertR. GrabowskiN. LorenzD. Industry perspective on artificial intelligence/machine learning in pharmacovigilance.Drug Saf.202245543944810.1007/s40264‑022‑01164‑5 35579809
     [Google Scholar]
  170. TangX. ZhengF. MaZ. ShenH. YaoZ. Comprehensive evaluation of leuprorelin-associated adverse events: Insights from FDA adverse event reporting system.Expert Opin. Drug Saf.202411010.1080/14740338.2024.2423680 39469972
     [Google Scholar]
  171. XieW.L. GeM.L. ChenD. ChenG.Q. MeiY.X. LaiY.J. Psychiatric disorders associated with fluoroquinolones: A pharmacovigilance analysis of the FDA adverse event reporting system database.Front. Pharmacol.202415143592310.3389/fphar.2024.1435923 39469624
     [Google Scholar]
  172. AgrawalP. PatrickS. ThomasM. Pharmacovigilance monitoring and treatment adherence in patients on antihypertensive drugs at a tertiary care centre.Drugs Context2024132024-5-210.7573/dic.2024‑5‑2 39469027
     [Google Scholar]
  173. WuS. HuW. ChenM. XiaoX. LiuR. A real-world pharmacovigilance study of FDA adverse event reporting system events for Lutetium-177-PSMA-617.Sci. Rep.20241412571210.1038/s41598‑024‑77889‑3 39468291
     [Google Scholar]
/content/journals/cds/10.2174/0115748863356840250112181406
Loading
Pharmacovigilance - Technological Advancements, Recent Developments and Innovations
Curr Drug Saf 20, 423 (2025); https://doi.org/10.2174/0115748863356840250112181406
/content/journals/cds/10.2174/0115748863356840250112181406
/content/journals/cds/10.2174/0115748863356840250112181406
Loading

Data & Media loading...


  • Article Type:     Review Article
Keyword(s): ADRs; artificial intelligence; global and national frameworks; machine learning; Pharmacovigilance; recent developments; regulatory compliance; technological advancements

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