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image of Revealing the Future of Pharmacovigilance in Precision Pharmaceutical Monitoring

Abstract

The growing popularity of personalized medicine presents new hazards and difficulties for pharmacovigilance. This implies that it needs to modify its current approach. This research examines how drug safety monitoring for certain medications evolves over time. We briefly discuss the connection between meticulous pharmacovigilance procedures and adaptable treatment approaches. We describe how pharmacogenetics may be used to make drugs safer and how genetic testing may be used to forecast a drug's potential side effects. With an emphasis on post-marketing monitoring in phase IV, we address shortcomings of research on pre-marketing and the need for a comprehensive strategy for medication safety. The significance of pharmacogenetics in reducing risk before exposure and the need to reconsider pharmacoepidemiological techniques for monitoring outcomes after exposure are discussed in the study. We emphasize the significance of including genetic patient-specific profiles in publications related to tailored therapy and the use of state-of-the-art computer techniques for data processing. We also discuss privacy, ethical, and data security issues that arise with precision medicine, emphasizing the consequences for patient consent and data management.

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2025-06-01

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References

  1. Mcbride W.G. Thalidomide and congenital abnormalities. Lancet 1961 278 7216 1358 10.1016/S0140‑6736(61)90927‑8
    [Google Scholar]
  2. Bégaud B. Chaslerie A. Haramburu F. Organization and results of drug vigilance in France. Rev. Epidemiol. Sante Publique 1994 42 5 416 423 [PubMed]. 7973001
    [Google Scholar]
  3. The Importance of Pharmacovigilance, Safety Monitoring of medicinal products. WHO Geneva 2002
    [Google Scholar]
  4. Effective communications in pharmacovigilance. International Conference on Developing Effective Communications in Pharmacovigilance Erice, Sicily; 1997 Sep 24-27
    [Google Scholar]
  5. Shuka S.S. Gidwani B. Pandey R. Rao S.P. Singh V. Importance of pharmacovigilance in Indian pharmaceutical industry. Asian J Res Pharm Sci. 2012 2 4 8
    [Google Scholar]
  6. Hornbuckle K. Wu H.H. Fung M.C. Evaluation of spontaneous adverse event reports by primary reporter - A 15-year review (1983 to 1997). Drug Inf. J. 1999 33 4 1117 1124 10.1177/009286159903300416
    [Google Scholar]
  7. Consumer reporting of ADRs. WHO Drug Inf. 2000 14 211 215
    [Google Scholar]
  8. Egberts T.C.G. Smulders M. de Koning F.H.P. Meyboom R.H.B. Leufkens H.G.M. Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals. BMJ 1996 313 7056 530 531 10.1136/bmj.313.7056.530 8789980
    [Google Scholar]
  9. Norwood P.K. Sampson A.R. A statistical methodology for postmarketing surveillance of adverse drug reaction reports. Stat. Med. 1988 7 10 1023 1030 10.1002/sim.4780071004 3206000
    [Google Scholar]
  10. Eichler H.G. Abadie E. Breckenridge A. Flamion B. Gustafsson L.L. Leufkens H. Rowland M. Schneider C.K. Bloechl-Daum B. Bridging the efficacy–effectiveness gap: A regulator’s perspective on addressing variability of drug response. Nat. Rev. Drug Discov. 2011 10 7 495 506 10.1038/nrd3501 21720406
    [Google Scholar]
  11. Huang Y.L. Moon J. Segal J.B. A comparison of active adverse event surveillance systems worldwide. Drug Saf. 2014 37 8 581 596 10.1007/s40264‑014‑0194‑3 25022829
    [Google Scholar]
  12. Alomar M. Tawfiq A.M. Hassan N. Palaian S. Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: Current status, challenges and the future. Ther. Adv. Drug Saf. 2020 11 2042098620938595 10.1177/2042098620938595 32843958
    [Google Scholar]
  13. Sherman R.E. Anderson S.A. Dal Pan G.J. Gray G.W. Gross T. Hunter N.L. LaVange L. Marinac-Dabic D. Marks P.W. Robb M.A. Shuren J. Temple R. Woodcock J. Yue L.Q. Califf R.M. Real-world evidence What is it and what can it tell us? N. Engl. J. Med. 2016 375 23 2293 2297 10.1056/NEJMsb1609216 27959688
    [Google Scholar]
  14. Schneeweiss S. Glynn R.J. Real-world data analytics fit for regulatory decision-making. Am. J. Law Med. 2018 44 2-3 197 217 10.1177/0098858818789429 30106649
    [Google Scholar]
  15. Issa A.M. Carleton B. Gerhard T. Filipski K.K. Freedman A.N. Kimmel S. Liu G. Longo C. Maitland-van der Zee A.H. Sansbury L. Zhou W. Bartlett G. Pharmacoepidemiology: A time for a new multidisciplinary approach to precision medicine. Pharmacoepidemiol. Drug Saf. 2021 30 8 985 992 10.1002/pds.5226 33715268
    [Google Scholar]
  16. De Pretis F. van Gils M. Forsberg M.M. A smart hospital-driven approach to precision pharmacovigilance. Trends Pharmacol. Sci. 2022 43 6 473 481 10.1016/j.tips.2022.03.009 35490032
    [Google Scholar]
  17. The National Academies Collection: Reports funded by National Institutes of Health National Academies Press Washington (DC) 2011
    [Google Scholar]
  18. Ellis C.A. Petrovski S. Berkovic S.F. Epilepsy genetics: Clinical impacts and biological insights. Lancet Neurol. 2020 19 1 93 100 10.1016/S1474‑4422(19)30269‑8 31494011
    [Google Scholar]
  19. Møller R.S. Hammer T.B. Rubboli G. Lemke J.R. Johannesen K.M. From next-generation sequencing to targeted treatment of non-acquired epilepsies. Expert Rev. Mol. Diagn. 2019 19 3 217 228 10.1080/14737159.2019.1573144 30661434
    [Google Scholar]
  20. Kim J. Hu C. Moufawad El Achkar C. Black L.E. Douville J. Larson A. Pendergast M.K. Goldkind S.F. Lee E.A. Kuniholm A. Soucy A. Vaze J. Belur N.R. Fredriksen K. Stojkovska I. Tsytsykova A. Armant M. DiDonato R.L. Choi J. Cornelissen L. Pereira L.M. Augustine E.F. Genetti C.A. Dies K. Barton B. Williams L. Goodlett B.D. Riley B.L. Pasternak A. Berry E.R. Pflock K.A. Chu S. Reed C. Tyndall K. Agrawal P.B. Beggs A.H. Grant P.E. Urion D.K. Snyder R.O. Waisbren S.E. Poduri A. Park P.J. Patterson A. Biffi A. Mazzulli J.R. Bodamer O. Berde C.B. Yu T.W. Patient-customized oligonucleotide therapy for a rare genetic disease. N. Engl. J. Med. 2019 381 17 1644 1652 10.1056/NEJMoa1813279 31597037
    [Google Scholar]
  21. Masimirembwa C. Dandara C. Leutscher P.D.C. Rolling out Efavirenz for HIV precision medicine in Africa: Are we ready for pharmacovigilance and tackling neuropsychiatric adverse effects? OMICS 2016 20 10 575 580 10.1089/omi.2016.0120 27627692
    [Google Scholar]
  22. Gloyn A.L. Drucker D.J. Precision medicine in the management of type 2 diabetes. Lancet Diabetes Endocrinol. 2018 6 11 891 900 10.1016/S2213‑8587(18)30052‑4 29699867
    [Google Scholar]
  23. Jing Y. Liu J. Ye Y. Pan L. Deng H. Wang Y. Yang Y. Diao L. Lin S.H. Mills G.B. Zhuang G. Xue X. Han L. Multi-omics prediction of immune-related adverse events during checkpoint immunotherapy. Nat. Commun. 2020 11 1 4946 10.1038/s41467‑020‑18742‑9 33009409
    [Google Scholar]
  24. Schwab M. Schaeffeler E. Pharmacogenomics: A key component of personalized therapy. Genome Med. 2012 4 11 93 10.1186/gm394 23194652
    [Google Scholar]
  25. Madigan D. Ryan P. Simpson S. Bernardo J.M. Bayarri M.J. Berger J.O. Bayesian methods in pharmacovigilance. Bayesian statistics. Oxford University Press Oxford 2011
    [Google Scholar]
  26. Lawson D.H. Pharmacoepidemiology: A new discipline. BMJ 1984 289 6450 940 941 10.1136/bmj.289.6450.940 6435731
    [Google Scholar]
  27. ICH E2E Pharmacovigilance planning (Pvp) scientific guideline. 2004 Available from: https://www.ema.europa.eu/en/ich-e2e-pharmacovigilance-planning-pvp-scientifc-guideline
  28. Bate A. Stegmann J.U. Safety of medicines and vaccines – Building next generation capability. Trends Pharmacol. Sci. 2021 42 12 1051 1063 10.1016/j.tips.2021.09.007 34635346
    [Google Scholar]
  29. Oldenhuis C.N.A.M. Oosting S.F. Gietema J.A. de Vries E.G.E. Prognostic versus predictive value of biomarkers in oncology. Eur. J. Cancer 2008 44 7 946 953 10.1016/j.ejca.2008.03.006 18396036
    [Google Scholar]
  30. Hey S.P. Gerlach C.V. Dunlap G. Prasad V. Kesselheim A.S. The evidence landscape in precision medicine. Sci. Transl. Med. 2020 12 540 eaaw7745 10.1126/scitranslmed.aaw7745 32321867
    [Google Scholar]
  31. Bonomi L. Huang Y. Ohno-Machado L. Privacy challenges and research opportunities for genomic data sharing. Nat. Genet. 2020 52 7 646 654 10.1038/s41588‑020‑0651‑0 32601475
    [Google Scholar]
  32. Hall-Flavin D.K. Winner J.G. Allen J.D. Carhart J.M. Proctor B. Snyder K.A. Drews M.S. Eisterhold L.L. Geske J. Mrazek D.A. Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting. Pharmacogenet. Genomics 2013 23 10 535 548 10.1097/FPC.0b013e3283649b9a 24018772
    [Google Scholar]
  33. Vuorinen A.L. Lehto M. Niemi M. Harno K. Pajula J. van Gils M. Lähteenmäki J. Pharmacogenetics of anticoagulation and clinical events in warfarin-treated patients: A register-based cohort study with biobank data and national health registries in Finland. Clin. Epidemiol. 2021 13 183 195 10.2147/CLEP.S289031 33727862
    [Google Scholar]
  34. Heo J.Y. Cho M.K. Kim S. Data mining for detecting signals of adverse drug reaction of doxycycline using the Korea adverse event reporting system database. J. Dermatolog. Treat. 2022 33 4 2192 2197 10.1080/09546634.2021.1937480 34057876
    [Google Scholar]
  35. Son J.H. Xie G. Yuan C. Ena L. Li Z. Goldstein A. Huang L. Wang L. Shen F. Liu H. Mehl K. Groopman E.E. Marasa M. Kiryluk K. Gharavi A.G. Chung W.K. Hripcsak G. Friedman C. Weng C. Wang K. Deep phenotyping on electronic health records facilitates genetic diagnosis by clinical exomes. Am. J. Hum. Genet. 2018 103 1 58 73 10.1016/j.ajhg.2018.05.010 29961570
    [Google Scholar]
  36. Karagiannidis E. Moysidis D.V. Papazoglou A.S. Panteris E. Deda O. Stalikas N. Sofidis G. Kartas A. Bekiaridou A. Giannakoulas G. Gika H. Theodoridis G. Sianos G. Prognostic significance of metabolomic biomarkers in patients with diabetes mellitus and coronary artery disease. Cardiovasc. Diabetol. 2022 21 1 70 10.1186/s12933‑022‑01494‑9 35525960
    [Google Scholar]
  37. Khattri S. Balamuralidhara V. Pramod K.T.M. Valluru R. Venkatesh M.P. Pharmacovigilance regulations in India: A step forward. Clin. Res. Regul. Aff. 2012 29 2 41 45 10.3109/10601333.2012.692688
    [Google Scholar]
  38. Kalantri S.P. Ethics in clinical research. Indian J. Anaesth. 2003 47 30 32
    [Google Scholar]
  39. Grady C. Payment of clinical research subjects. J. Clin. Invest. 2005 115 7 1681 1687 10.1172/JCI25694 16007244
    [Google Scholar]
  40. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice E6 Madrid, Spain, 13 - 14 May 2025
    [Google Scholar]
  41. Code of Federal Regulations Title 21. Sec. 312.33 IND Annual Reports. 2010 Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.33
  42. Detailed Guidance on the Collection, Verification and Presentation of Adverse Reaction Reports Arising from Clinical Trials on Medicinal Products for Human Use. 2006 Available from: http://ec.europa.eu/health/files/eudralex/vol-10/21_susar_rev2_2006_04_11_en.pdf
  43. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Final Concept Paper- E2F-Development Safety Update Report.
    [Google Scholar]
  44. Cioms C.H. Benefit-risk balance for marketed drugs. Evaluating safety signals: Report of CIOMS working group IV. Geneva CIOMS 1998
    [Google Scholar]
  45. Lazarou J. Pomeranz B.H. Corey P.N. Incidence of ADRs in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998 279 1200 1205 10.1001/jama.279.15.1200 9555760
    [Google Scholar]
  46. White T.J. Arakelian A. Rho J.P. Counting the costs of drug-related adverse events. PharmacoEconomics 1999 15 5 445 458 10.2165/00019053‑199915050‑00003 10537962
    [Google Scholar]
  47. Avorn J. Solomon D.H. Cultural and economic factors that (mis)shape antibiotic use: The nonpharmacologic basis of therapeutics. Ann. Intern. Med. 2000 133 2 128 135 10.7326/0003‑4819‑133‑2‑200007180‑00012 10896639
    [Google Scholar]
  48. Ball L.K. Evans G. Bostrom A. Risky business: Challenges in vaccine risk communication. Pediatrics 1998 101 3 453 458 10.1542/peds.101.3.453 9481013
    [Google Scholar]
  49. Bapna J.S. Tripathi C.D. Tekur U. Drug utilisation patterns in the Third World. PharmacoEconomics 1996 9 4 286 294 10.2165/00019053‑199609040‑00002 10160103
    [Google Scholar]
  50. McGettigan P. Roderick P. Kadam A. Pollock A.M. Access to data from clinical trials: The future in the EU. BMJ 2017 357 j2350
    [Google Scholar]
  51. Hanley J.A. Pharmacovigilance: Learning from multiple sources of data. Pharmacoepidemiol. Drug Saf. 2017 26 1 3 4 29047193
    [Google Scholar]
  52. Xaviar S. Kumar S. Ramasamy K. Chakradhara Rao U.S. Indo-Swiss symposium on advances in pharmacogenomic strategies for implementation of personalized medicine. Pharmacogenomics 2021 22 2 67 71 10.2217/pgs‑2020‑0111 33305611
    [Google Scholar]
  53. Devanathan R. Alladi C.G. Ravichandran M. Ramasamy K. Uppugunduri C.R.S. Impact of pharmacogenomics in achieving personalized/precision medicine in the clinical setting: A symposium report. Pharmacogenomics 2023 24 3 123 129 10.2217/pgs‑2022‑0194 36786192
    [Google Scholar]
  54. Epstein R.S. Moyer T.P. Aubert R.E. O’Kane D.J. Xia F. Verbrugge R.R. Gage B.F. Teagarden J.R. Warfarin genotyping reduces hospitalization rates results from the MM-WES (Medco-Mayo Warfarin Effectiveness study). J. Am. Coll. Cardiol. 2010 55 25 2804 2812 10.1016/j.jacc.2010.03.009 20381283
    [Google Scholar]
  55. Zhang X. Jiang S. Xue J. Ding Y. Gu J. Hu L. Xu X. Li Z. Kong Y. Li Y. Zhu X. Yue Y. Personalized antiplatelet therapy guided by clopidogrel pharmacogenomics in acute ischemic stroke and transient ischemic attack: A prospective, randomized controlled trial. Front. Pharmacol. 2023 13 931405 10.3389/fphar.2022.931405 36744212
    [Google Scholar]
  56. Van den Berghe N. Gils A. Thomas D. Achieving mucosal healing in inflammatory bowel diseases: Which drug concentrations need to be targeted? Clin. Pharmacol. Ther. 2019 106 5 945 954 10.1002/cpt.1609 31420861
    [Google Scholar]
  57. Gaedigk A. Blum M. Gaedigk R. Eichelbaum M. Meyer U.A. Deletion of the entire cytochrome P450 CYP2D6 gene as a cause of impaired drug metabolism in poor metabolizers of the debrisoquine/sparteine polymorphism. Am. J. Hum. Genet. 1991 48 5 943 950 1673290
    [Google Scholar]
  58. Swen J.J. van der Wouden C.H. Manson L.E.N. Abdullah-Koolmees H. Blagec K. Blagus T. Böhringer S. Cambon-Thomsen A. Cecchin E. Cheung K.C. Deneer V.H.M. Dupui M. Ingelman-Sundberg M. Jonsson S. Joefield-Roka C. Just K.S. Karlsson M.O. Konta L. Koopmann R. Kriek M. Lehr T. Mitropoulou C. Rial-Sebbag E. Rollinson V. Roncato R. Samwald M. Schaeffeler E. Skokou M. Schwab M. Steinberger D. Stingl J.C. Tremmel R. Turner R.M. van Rhenen M.H. Dávila Fajardo C.L. Dolžan V. Patrinos G.P. Pirmohamed M. Sunder-Plassmann G. Toffoli G. Guchelaar H.J. Buunk A. Goossens H. Baas G. Algera M. Schuil-Vlassak E. Ambagts T. De Hoog-Schouten L. Musaafir S. Bosch R. Tjong C. Steeman S. Van der Plas M. Baldew G. Den Hollander I. De Waal Z. Heijn A. Nelemans L. Kouwen-Lubbers K. Van Leeuwen M. Hoogenboom S. Van Doremalen J. Ton C. Beetstra B. Meijs V. Dikken J. Dubero D. Slager M. Houben T. Kanis T. Overmars W. Nijenhuis M. Steffens M. Bergs I. Karamperis K. Siamoglou S. Ivantsik O. Samiou G-C. Kordou Z. Tsermpini E. Ferentinos P. Karaivazoglou A. Rigas G. Gerasimou H. Voukelatou G. Georgila E. Tsermpini E.E. Mendrinou E. Chalikiopoulou K. Kolliopoulou A. Mitropoulos K. Stratopoulos A. Liopetas I. Tsikrika A. Barba E. Emmanouil G. Stamopoulou T. Stathoulias A. Giannopoulos P. Kanellakis F. Bartsakoulia M. Katsila T. Douzenis A. Gourzis F. Assimakopoulos K. Bignucolo A. Dal Cin L. Comello F. Mezzalira S. Puglisi F. Spina M. Foltran L. Guardascione M. Buonadonna A. Bartoletti M. Corsetti S. Ongaro E. Da Ros L. Bolzonello S. Spazzapan S. Freschi A. Di Nardo P. Palazzari E. Navarria F. Innocente R. Berretta M. D’Andrea M. Angelini F. Diraimo T. Favaretto A. Dávila-Fajardo C.L. Díaz-Villamarín X. Martínez-González L.J. Antúnez-Rodríguez A. Moreno-Escobar E. Fernández-Gómez A.E. García-Navas P. Bautista-Pavés A.B.P. Burillo-Gómez F. Villegas-Rodríguez I. Sánchez-Ramos J.G. Antolinos-Pérez M.J. Rivera R. Martínez-Huertas S. Thomas-Carazo J. Yañez-Sanchez J.J. Blancas-López-Barajas M.I. García-Orta R. González-Astorga B. Rodríguez-González C.J. Ruiz-Carazo F.J. Pérez-Campos M. Cano-Herrera I. Herrera R. Gil-Jiménez T. Delgado-Ureña M.T. Triviño-Juarez J.M. Campos-Velázquez S. Alcántara- Espadafor S. Moreno Aguilar M.R. Ontiveros- Ortega M.C. Carnerero-Córdoba L. Guerrero-Jiménez M. Legeren- Álvarez M. Yélamos-Vargas M. Castillo-Pérez I. Aomar-Millán I. Anguita-Romero M. Sánchez-García M.J. Sequero-Lopez S. Faro-Miguez N. López-Fernández S. Leyva-Ferrer R.N. Herrera-Gómez N. Pertejo-Manzano L. Pérez-Gutierrez E.M. Martín-de la Higuera A.J. Plaza-Carrera J. Baena-Garzón F. Toledo-Frías P. Cruz-Valero I. Chacón-McWeeny V. Gallardo- Sánchez I. Arrebola A. Guillén-Zafra L. Ceballos-Torres Á. Guardia-Mancilla P. Guirao-Arrabal E. Canterero-Hinojosa J. Velasco-Fuentes S. Sánchez- Cano D. Aguilar-Jaldo M.P. Caballero-Borrego J. Praznik M. Slapšak U. Voncina B. Rajter B. Škrinjar A. Marjetic Ulcakar A. Zidanšek A. Stegne Ignjatvic T. Mazej Poredoš B. Vivod Pecnik Ž. Poplas Susic T. Juteršek M. Klen J. Skoporc J. Kotar T. Petek Šter M. Zvezdana Dernovšk M. Klen J. Mlinšek G. Miklavcic P. Plemenitaš Ilješ A. Grašic Kuhar C. Oblak I. Stražišar B. Štrbac D. Matos E. Mencinger M. Vrbnjak M. Saje M. Radovanovic M. Jeras K. Bukovec L. Terzic T. Minichmayr I. Nanah A. Nielsen E. Zou Y. Lauschke V. Johansson I. Zhou Y. Nordling Å. Aigner C. Dames-Ludwig M. Monteforte R. Sunder-Plassmann R. Steinhauser C. Sengoelge G. Winnicki W. Schmidt A. Vasileios F. Fontana V. Hanson A. Little M. Hornby R. Dello Russo C. French S. Hampson J. Gumustekin M. Anyfantis G. Hampson L. Lewis D. Westhead R. Prince C. Rajasingam A. A 12-gene pharmacogenetic panel to prevent adverse drug reactions: An open-label, multicentre, controlled, cluster-randomised crossover implementation study. Lancet 2023 401 10374 347 356 10.1016/S0140‑6736(22)01841‑4 36739136
    [Google Scholar]
  59. The Scope Significance of Progress in 2021 2021 Available from: www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/Personalized Medicine at FDA The Scope Significance of Progress in 2021.pdf
  60. Relling M.V. Evans W.E. Pharmacogenomics in the clinic. Nature 2015 526 7573 343 350 10.1038/nature15817 26469045
    [Google Scholar]
  61. Nagy M. Lynch M. Kamal S. Mohamed S. Hadad A. Abouelnaga S. Aquilante C.L. Assessment of healthcare professionals’ knowledge, attitudes, and perceived challenges of clinical pharmacogenetic testing in Egypt. Per. Med. 2020 17 4 251 260 10.2217/pme‑2019‑0163 32589096
    [Google Scholar]
  62. Ciszkowski C. Madadi P. Phillips M.S. Lauwers A.E. Koren G. Codeine, ultrarapid-metabolism genotype, and postoperative death. N. Engl. J. Med. 2009 361 8 827 828 10.1056/NEJMc0904266 19692698
    [Google Scholar]
  63. Pirmohamed M. Burnside G. Eriksson N. Jorgensen A.L. Toh C.H. Nicholson T. Kesteven P. Christersson C. Wahlström B. Stafberg C. Zhang J.E. Leathart J.B. Kohnke H. Maitland-van der Zee A.H. Williamson P.R. Daly A.K. Avery P. Kamali F. Wadelius M. EU-PACT Group A randomized trial of genotype-guided dosing of warfarin. N. Engl. J. Med. 2013 369 24 2294 2303 10.1056/NEJMoa1311386 24251363
    [Google Scholar]
  64. Hicks J.K. El Rouby N. Ong H.H. Schildcrout J.S. Ramsey L.B. Shi Y. Anne Tang L. Aquilante C.L. Beitelshees A.L. Blake K.V. Cimino J.J. Davis B.H. Empey P.E. Kao D.P. Lemkin D.L. Limdi N.A. P Lipori G. Rosenman M.B. Skaar T.C. Teal E. Tuteja S. Wiley L.K. Williams H. Winterstein A.G. Van Driest S.L. Cavallari L.H. Peterson J.F. Opportunity for genotype-guided prescribing among adult patients in 11 US health systems. Clin. Pharmacol. Ther. 2021 110 1 179 188 10.1002/cpt.2161 33428770
    [Google Scholar]
  65. Morris S.A. Alsaidi A.T. Verbyla A. Cruz A. Macfarlane C. Bauer J. Patel J.N. Cost effectiveness of pharmacogenetic testing for drugs with Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines: A systematic review. Clin. Pharmacol. Ther. 2022 112 6 1318 1328 10.1002/cpt.2754 36149409
    [Google Scholar]
  66. Sukri A. Salleh M.Z. Masimirembwa C. Teh L.K. A systematic review on the cost effectiveness of pharmacogenomics in developing countries: Implementation challenges. Pharmacogenomics J. 2022 22 3 147 159 10.1038/s41397‑022‑00272‑w 35319010
    [Google Scholar]
  67. Chang W.C. Tanoshima R. Ross C.J.D. Carleton B.C. Challenges and opportunities in implementing pharmacogenetic testing in clinical settings. Annu. Rev. Pharmacol. Toxicol. 2021 61 1 65 84 10.1146/annurev‑pharmtox‑030920‑025745 33006916
    [Google Scholar]
  68. Pharmacovigilance The National Academies Press Washington, DC 2008
    [Google Scholar]
  69. Looking at the Pharmacovigilance: Ensuring the safe use of medicines. World Health Organization Geneva
    [Google Scholar]
  70. Härmark L. van Grootheest A.C. Pharmacovigilance: Methods, recent developments and future perspectives. Eur. J. Clin. Pharmacol. 2008 64 8 743 752 10.1007/s00228‑008‑0475‑9 18523760
    [Google Scholar]
  71. Biswas P. Biswas A. Setting standards for proactive pharmacovigilance in India: The way forward. Indian J. Pharmacol. 2007 39 3 124 128 10.4103/0253‑7613.33431
    [Google Scholar]
  72. The Importance of pharmacovigilance Safety monitoring of medicinal products. WHO Lib Catalog 2002
    [Google Scholar]
  73. WHO Handbook of resolutions and decisions of the World Health Assembly and Executive Board. Geneva World Health Organization 1973
    [Google Scholar]
  74. Lared NL Pharmacists' role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf. 13 7 457 464
    [Google Scholar]
  75. Medicines Strategy WHO WHO medicines strategy: Framework for action in essential drugs and medicines policy 2000-2003. 2000 Available from: https://iris.who.int/bitstream/handle/10665/66503/WHO_EDM_2000.1.pdf
  76. Olsson S. The role of the WHO programme on International Drug Monitoring in coordinating worldwide drug safety efforts. Drug Saf. 1998 19 1 1 10 10.2165/00002018‑199819010‑00001 9673854
    [Google Scholar]
  77. Coulter D.M. The New Zealand intensive medicines monitoring programme in pro-active safety surveillance. Pharmacoepidemiol. Drug Saf. 2000 9 4 273 280 10.1002/1099‑1557(200007/08)9:4<273::AID‑PDS512>3.0.CO;2‑T 19025828
    [Google Scholar]
  78. Mackay F.J. Post-Marketing Studies. Drug Saf. 1998 19 5 343 353 10.2165/00002018‑199819050‑00002 9825948
    [Google Scholar]
  79. Folb P.I. ten Ham M. Drug monitoring in developing countries: A drug regulator’s perspective. Drug Inf. J. 1995 29 1 303 305 10.1177/009286159502900133
    [Google Scholar]
  80. Talbot J.C.C. Nilsson B.S. Pharmacovigilance in the pharmaceutical industry. Br. J. Clin. Pharmacol. 1998 45 5 427 431 10.1046/j.1365‑2125.1998.00713.x 9643613
    [Google Scholar]
  81. Moore N. The role of the clinical pharmacologist in the management of ADRs. Drug Saf. 2001 24 1 7 10.2165/00002018‑200124010‑00001 11219484
    [Google Scholar]
  82. Hall M. McCormack P. Arthurs N. Feely J. The spontaneous reporting of ADRs by nurses. Br. J. Clin. Pharmacol. 1995 40 173 175 10.1111/j.1365‑2125.1995.tb05774.x 8562303
    [Google Scholar]
  83. Lucas S. Ailani J. Smith T.R. Abdrabboh A. Xue F. Navetta M.S. Pharmacovigilance: Reporting requirements throughout a product’s lifecycle. Ther. Adv. Drug Saf. 2022 13 20420986221125006 10.1177/20420986221125006 36187302
    [Google Scholar]
  84. Aziz A.A. Rogers S. Hassanien O. Shalaby L. Nagy M. Knowledge, attitudes and practice regarding pharmacovigilance and adverse drug reaction reporting among physicians and pharmacists in Egypt: A step toward personalized medicine implementation. Per. Med. 2022 19 6 495 507 10.2217/pme‑2022‑0030 36239598
    [Google Scholar]
  85. Doan T. Lievano F. Scarazzini L. Schubert C. Hendrickson B. Pharmacovigilance-E-BOOK: Pharmacovigilance-E-BOOK. Elsevier Health Sciences 2025
    [Google Scholar]
  86. Kosorok M.R. Laber E.B. Precision medicine. Annu. Rev. Stat. Appl. 2019 6 1 263 286 10.1146/annurev‑statistics‑030718‑105251 31073534
    [Google Scholar]
  87. Kumar S. Maharshi V. Signal Analysis in Pharmacovigilance. CRC Press 2025 1 21
    [Google Scholar]
/content/journals/cds/10.2174/0115748863355987250223072145
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Revealing the Future of Pharmacovigilance in Precision Pharmaceutical Monitoring
Bentham Science Publishers ; https://doi.org/10.2174/0115748863355987250223072145
/content/journals/cds/10.2174/0115748863355987250223072145
/content/journals/cds/10.2174/0115748863355987250223072145
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  • Article Type:     Review Article
Keywords: drug safety ; patient outcomes ; pharmacogenomics ; Personalized medicine ; precision medicine ; pharmacovigilance

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