Skip to content
2000
image of Enhancing Pharmacovigilance in Pharmaceutical Companies: A Comparative Study of Electronic Reporting Before and After Implementation

Abstract

Background

Since 2016, Moroccan pharmaceutical companies have been required to report adverse effects linked to their medicines. Initially, reports were submitted using the CIOMS form, sent by normal mail to le Centre Antipoison et de Pharmacovigilance du Maroc, then using XML files in ICH E2B format, sent electronically. In 2021, a “vigiflow e-reporting for industry” standardized online reporting system was implemented. The primary objective of this study was to evaluate the pharmaceutical companies' use of electronic reporting. Secondarily, the study aimed to assess the quality of adverse drug reaction reports by comparing completeness scores across the three reporting means.

Methods

All individual case safety reports sent by pharmaceutical companies from January 1, 2019, to December 31, 2023, were extracted from Vigibase®. A quantitative and qualitative analysis was conducted, and a statistical comparison of data was performed using -values. VigiGrade completeness score was calculated for a sample size selected.

Results

The highest number of reports were from E-reporting (50%), followed by CIOMS (29%) and E2B (21%). Between 2019 and 2021, CIOMS and E2B notifications decreased along with reporting laboratories. However, after 2021, electronic reporting increased steadily alongside reporting companies. Comparing vigiGrade completeness score across reporting means revealed no statistically significant differences ( = 0.094 > 0.05).

Discussion

The increasing use of e-reporting indicates evolving pharmacovigilance practices. However, similar completeness scores across methods suggest that digital tools alone are insufficient to improve reporting quality. Training and support remain essential.

Conclusion

Electronic reporting shows quantitative effectiveness and consistent quality. Its adoption remains limited and requires continuous strengthening, particularly through increased awareness among pharmaceutical companies

© 2025 Bentham Science Publishers
Loading

Article metrics loading...

/content/journals/cds/10.2174/0115748863339571250610103928
2025-06-30
2025-09-14

  • From This Site

    /content/journals/cds/10.2174/0115748863339571250610103928
    dcterms_title,dcterms_subject,pub_keyword
    -contentType:Contributor -contentType:Concept -contentType:Institution
    10
    5
Loading full text...

Full text loading...

References

  1. Khan M.A.A. Sara T. Babar Z.U.D. Pharmacovigilance: The evolution of drug safety monitoring. J. Pharm. Policy Pract. 2024 17 1 2417399 10.1080/20523211.2024.2417399 39450127
    [Google Scholar]
  2. Edwards I.R. Aronson J.K. Adverse drug reactions: Definitions, diagnosis, and management. Lancet 2000 356 9237 1255 1259 10.1016/S0140‑6736(00)02799‑9 11072960
    [Google Scholar]
  3. Fornasier G. Francescon S. Leone R. Baldo P. An historical overview over Pharmacovigilance. Int. J. Clin. Pharm. 2018 40 4 744 747 10.1007/s11096‑018‑0657‑1 29948743
    [Google Scholar]
  4. Salvador M.R. Monteiro C. Pereira L. Duarte A.P. Quality of spontaneous reports of adverse drug reactions sent to a regional pharmacovigilance unit. Int. J. Environ. Res. Public Health 2022 19 7 3754 10.3390/ijerph19073754 35409436
    [Google Scholar]
  5. Suraj U. Kamble Sanjay K. Review on adverse drug reactions. IJARSCT 2023 25 342 351
    [Google Scholar]
  6. Montané E. Santesmases J. Adverse drug reactions. Med. Clín. 2020 154 5 178 184 31771857
    [Google Scholar]
  7. Sharma R. Kellarai A. Pharmacovigilance and adverse drug reaction reporting perspectives among interns and postgraduates of a teaching hospital. J. Pharmacol. Pharmacother. 2014 5 4 248 250 10.4103/0976‑500X.142436 25422565
    [Google Scholar]
  8. Prasad Gajanan Chokhande Mr. Adverse drug reaction of melanocyl ointment. IJARSCT. 2024 30 326 337
    [Google Scholar]
  9. Klepper M.J. Edwards B. Individual case safety reports--how to determine the onset date of an adverse reaction: A survey. Drug Saf. 2011 34 4 299 305 10.2165/11588490‑000000000‑00000 21417502
    [Google Scholar]
  10. S G. Devipriya S. M S.K. C R.B. S. G Analysis of individual case safety reports of spontaneous reporting in adverse drug reaction monitoring centre at a tertiary care hospital. Int. J. Basic Clin. Pharmacol. 2022 11 6 587 10.18203/2319‑2003.ijbcp20222739
    [Google Scholar]
  11. Sardella M. Belcher G. Lungu C. Ignoni T. Camisa M. Stenver D.I. Porcelli P. D’Antuono M. Castiglione N.G. Adams A. Furlan G. Grisoni I. Hall S. Boga L. Mancini V. Ciuca M. Chonzi D. Edwards B. Mangoni A.A. Tuccori M. Prokofyeva E. Gregorio D.F. Broglio B.G.M. Leeuwen V.B. Kruger P. Rausch C. Louet L.H. Monitoring the manufacturing and quality of medicines: A fundamental task of pharmacovigilance. Ther. Adv. Drug Saf. 2021 12 20420986211038436 10.1177/20420986211038436 34394910
    [Google Scholar]
  12. Lindquist M. VigiBase, the WHO GLOBAL ICSR database system: Basic facts. Drug Inf. J. 2008 42 5 409 419 10.1177/009286150804200501
    [Google Scholar]
  13. 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]
  14. Santoro A. Genov G. Spooner A. Raine J. Arlett P. Promoting and protecting public health: How the european union pharmacovigilance system works. Drug Saf. 2017 40 10 855 869 10.1007/s40264‑017‑0572‑8 28735357
    [Google Scholar]
  15. Hazell L. Shakir S.A.W. Under-reporting of adverse drug reactions : A systematic review. Drug Saf. 2006 29 5 385 396 10.2165/00002018‑200629050‑00003 16689555
    [Google Scholar]
  16. Putri R.A. Ikawati Z. Rahmawati F. Yasin N.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. 2024 19 3 317 331 10.2174/0115748863276456231016062628 38989832
    [Google Scholar]
  17. National Pharmacovigilance Center RL. The Pharmacovigilance Good Practices Manual. Available from: https://www.cap-m-sante.ma/uploads/documents/BPPV.pdf
  18. Alshammari T.M. Mendi N. Alenzi K.A. Alsowaida Y. Pharmacovigilance systems in arab countries: Overview of 22 arab countries. Drug Saf. 2019 42 7 849 868 10.1007/s40264‑019‑00807‑4 31006085
    [Google Scholar]
  19. Directive 2010/84/EU of the european parliament and of the council. 2024 Available from: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF
  20. Niu R. Xiang Y. Wu T. Zhang Z. Chen Y. Feng B. The quality of spontaneous adverse drug reaction reports from the pharmacovigilance centre in western China. Expert Opin. Drug Saf. 2019 18 1 51 58 10.1080/14740338.2019.1559812 30574811
    [Google Scholar]
  21. Hanzl-Dujmović I. Sulić-Milišić Z. Starešinić-Šernhorst I. Issues with regulatory pharmacovigilance in East European countries: The industry perspective. Toxicol. Lett. 2007 168 3 228 235 10.1016/j.toxlet.2006.10.019 17161561
    [Google Scholar]
  22. Ministry of Health. Organization of the National Pharmacovigilance System. Available from: https://www.sante.gov.ma/Reglementation/SYSTEMEDESANTEETOFFREDESOINS/Organisation%20du%20Syst%C3%A8me%20National%20de%20Pharmacovigilance.pdf
    [Google Scholar]
  23. Edwards B. Managing the interface with marketing to improve delivery of pharmacovigilance within the pharmaceutical industry. 2004 Available from: https://link.springer.com/article/10.2165/00002018-200427080-00012
  24. Faich G.A. Castle W. Bankowski Z. International adverse drug reaction reporting: The cioms project. Drug Inf. J. 1990 24 2 419 425 10.1177/009286159002400216
    [Google Scholar]
  25. Younus M.M. Zweygarth M. Rägo L. Harrison-Woolrych M. The work of the council for international organizations of medical sciences (CIOMS) in global pharmacovigilance. Drug Saf. 2020 43 11 1067 1071 10.1007/s40264‑020‑01003‑5 33034859
    [Google Scholar]
  26. Olsson S. Recent Developments in Pharmacovigilance at UMC. Pharmaceutical Medicine and Translational Clinical Research. Amsterdam, Netherlands Elsevier 2018 435 442 10.1016/B978‑0‑12‑802103‑3.00032‑8
    [Google Scholar]
  27. Habarugira J.M.V. Figueras A. Pharmacovigilance network as an additional tool for the surveillance of antimicrobial resistance. Pharmacoepidemiol. Drug Saf. 2021 30 8 1123 1131 10.1002/pds.5249 33864401
    [Google Scholar]
  28. Pharmacovigilance W.H.O. WHO pharmacovigilance. regulation and prequalification. Available from: https://www.who.int/teams/regulation-prequalification/pharmacovigilance
  29. Vogler M. Conesa R.H. Ferreira A.D.K. Cruz M.F. Gasparotto S.F. Fleck K. Rebelo M.F. Kollross B. Gonçalves S.Y. Electronic reporting systems in pharmacovigilance: The implementation of vigiflow in brazil. Pharmaceut. Med. 2020 34 5 327 334 10.1007/s40290‑020‑00349‑6 32930977
    [Google Scholar]
  30. Lomeli-Silva A. Contreras-Salinas H. Barajas-Virgen M.Y. Romero-Lopez M.S. Rodríguez-Herrera L.Y. Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: A review of their current regulation. Ther. Adv. Drug Saf. 2024 15 20420986241228119 10.1177/20420986241228119 38323190
    [Google Scholar]
  31. Electronic transmission of individual case safety reports (ICSRs) - data elements and message specification - implementation guide - Scientific guideline. Available from: https://www.ema.europa.eu/en/ich-e2b-r3-electronic-transmission-individual-case-safety-reports-icsrs-data-elements-message-specification-implementation-guide-scientific-guideline
  32. Rayón-Ramírez G. Alvarado-López S. Camacho-Sandoval R. Strengthening the Pharmacovigilance System in Mexico: Implementation of VigiFlow and VigiLyze, as ICSR and Signal Detection Management Systems. Pharmaceut. Med. 37 6 425 437 10.1007/s40290‑023‑00490‑y
    [Google Scholar]
  33. Min C. The importance of a World Health Organization international pharmacovigilance database (VigiBase): Novel methods for safety monitoring and surveillance of medical products. Life Cycle 2022 2 e13 10.54724/lc.2022.e13
    [Google Scholar]
  34. Brown E.G. Wood L. Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf. 1999 20 2 109 117 10.2165/00002018‑199920020‑00002 10082069
    [Google Scholar]
  35. Lagerlund O. Strese S. Fladvad M. Lindquist M. WHO drug: A global, validated and updated dictionary for medicinal information. Ther. Innov. Regul. Sci. 2020 54 5 1116 1122 10.1007/s43441‑020‑00130‑6 32078733
    [Google Scholar]
  36. Bergvall T. Norén G.N. Lindquist M. vigiGrade: A tool to identify well-documented individual case reports and highlight systematic data quality issues. Drug Saf. 2014 37 1 65 77 10.1007/s40264‑013‑0131‑x 24343765
    [Google Scholar]
  37. Durrieu G. Jacquot J. Mège M. Bondon-Guitton E. Rousseau V. Montastruc F. Montastruc J.L. Completeness of spontaneous adverse drug reaction reports sent by general practitioners to a regional pharmacovigilance centre: A descriptive study. Drug Saf. 2016 39 12 1189 1195 10.1007/s40264‑016‑0463‑4 27688025
    [Google Scholar]
  38. Tsuchiya M. Obara T. Miyazaki M. Noda A. Takamura C. Mano N. The quality assessment of the japanese adverse drug event report database using vigigrade. Int. J. Clin. Pharm. 2020 42 2 728 736 10.1007/s11096‑020‑00969‑7 32020439
    [Google Scholar]
  39. Thompson S.K. Sampling. 2012 Available from: https://onlinelibrary.wiley.com/doi/book/10.1002/9781118162934 [cited 2025 Feb 6]
  40. Hennig R. Electronic reporting for clinical drug safety and pharmacovigilance. Expert Opin. Drug Saf. 2 2 195 197 10.1517/14740338.2.2.195
    [Google Scholar]
  41. Database: Industrial Pharmaceutical Establishments. Available from: https://dmp.sante.gov.ma/basesdedonnes/etablissements-pharmaceutiques-industriels [cited 2024 Feb 6].
  42. Combi C. Zorzi M. Pozzani G. Moretti U. Arzenton E. From narrative descriptions to MedDRA: Automagically encoding adverse drug reactions. J. Biomed. Inform. 2018 84 184 199 10.1016/j.jbi.2018.07.001 29981491
    [Google Scholar]
  43. Zorzi M. Combi C. Lora R. Pagliarini M. Moretti U. Automagically encoding adverse drug reactions in MedDRA International Conference on Healthcare Informatics 2015, pp. 90-99. 10.1109/ICHI.2015.18
    [Google Scholar]
  44. Meldau E.L. Bista S. Rofors E. Gattepaille L.M. Automated drug coding using artificial intelligence: An evaluation of whodrug koda on adverse event reports. Drug Saf. 2022 45 5 549 561 10.1007/s40264‑022‑01162‑7 35579817
    [Google Scholar]
  45. Stagi L. Bocchi I. Bernardini D. Ciappa M. Dellon S. Castiglione G.N. Romano S. Fabrizi E. Mattavelli A. Grisoni I. Finizia G. Bonato S. The evolution of the Pharmacovigilance department in the pharmaceutical industry: Results of an Italian national survey. Ther. Adv. Drug Saf. 2024 15 20420986241293296 10.1177/20420986241293296 39502880
    [Google Scholar]
  46. Radecka A. Loughlin L. Foy M. Guimaraes F.D.M.V. Sarinic V.M. Giusti D.M.D. Lesicar M. Straus S. Montero D. Pallos J. Ivanovic J. Raine J. Enhancing pharmacovigilance capabilities in the eu regulatory network: The scope joint action. Drug Saf. 2018 41 12 1285 1302 10.1007/s40264‑018‑0708‑5 30128638
    [Google Scholar]
  47. Masurkar P.P. A need of better pharmacovigilance system in india. Asian J. Pharm. Clin. Res. 2016 10 1 22 10.22159/ajpcr.2017.v10i1.14797
    [Google Scholar]
  48. Ribeiro-Vaz I. Silva A.M. Santos C.C. Cruz-Correia R. How to promote adverse drug reaction reports using information systems – a systematic review and meta-analysis. BMC Med. Inform. Decis. Mak. 2016 16 1 27 10.1186/s12911‑016‑0265‑8 26926375
    [Google Scholar]
  49. Abadie D. Chebane L. Bert M. Durrieu G. Montastruc J.L. Online reporting of adverse drug reactions: A study from a French regional pharmacovigilance center. Therapie 2014 69 5 395 400 10.2515/therapie/2014035 25269141
    [Google Scholar]
  50. Lynn RM Riding K McIntosh N The use of electronic reporting to aid surveillance of adverse drug reactions (ADRs) in children: A proof of concept study. Arch. Dis. Child. 2010 95 4 262 265 10.1136/adc.2009.158766
    [Google Scholar]
  51. Kim S. Kang T. Chung T.K. Choi Y. Hong Y. Jung K. Lee H. Automatic extraction of comprehensive drug safety information from adverse drug event narratives in the korea adverse event reporting system using natural language processing techniques. Drug Saf. 2023 46 8 781 795 10.1007/s40264‑023‑01323‑2 37330415
    [Google Scholar]
  52. Betancourt L.R. Vigil J.L.G. Santillan D.H. Gutierrez L.J. Pharmacovigilance III: The International Experience. Available from: https://www.redalyc.org/pdf/4577/457745541006.pdf [cited 2025 Feb 5].
  53. Alenzi K.A. Alanazi N.S. Almalki M. alomrani H. Alatawi F.O. The evaluation of adverse drug reactions in Saudi Arabia: A retrospective observational study. Saudi Pharm. J. 2022 30 6 735 741 10.1016/j.jsps.2022.03.018 35812140
    [Google Scholar]
  54. Trenque A. Rabiaza A. Fedrizzi S. Chretien B. Sassier M. Morello R. Alexandre J. Humbert X. Evaluation of a simplified pharmacovigilance tool for general practitioners: 5 years of insight. Sci. Rep. 2024 14 1 1766 10.1038/s41598‑024‑51753‑w 38243051
    [Google Scholar]
  55. Jalali R.K. Individual case safety reports. Pharmaceutical medicine and translational clinical research. Amsterdam, Netherlands Elsevier 2018 413 418 10.1016/B978‑0‑12‑802103‑3.00029‑8
    [Google Scholar]
  56. Plessis L. Gómez A. García N. Cereza G. Figueras A. Lack of essential information in spontaneous reports of adverse drug reactions in Catalonia—a restraint to the potentiality for signal detection. Eur. J. Clin. Pharmacol. 2017 73 6 751 758 10.1007/s00228‑017‑2223‑5 28251276
    [Google Scholar]
  57. Impicciatore P. Mucci M. Completeness of published case reports on suspected adverse drug reactions: Evaluation of 100 reports from a company safety database. Drug Saf. 2010 33 9 765 773 10.2165/11537500‑000000000‑00000 20701409
    [Google Scholar]
  58. Ferguson J.A. Mockbee C. Erbele S. Muniz E. Evaluation of published case reports’ standards and notification. Drug Inf. J. 2002 36 2 303 307 10.1177/009286150203600208
    [Google Scholar]
  59. McCarthy M. Drug makers’ adverse event reports are often incomplete, US report finds. BMJ 2015 350 h651 10.1136/bmj.h651
    [Google Scholar]
  60. Tagne F.J. Yakob R.A. Dang T.H. Mcdonald R. Wickramasinghe N. Reporting, monitoring, and handling of adverse drug reactions in australia: Scoping review. JMIR Public Health Surveill. 2023 9 e40080 10.2196/40080 36645706
    [Google Scholar]
  61. Christ P. Dubrall D. Schmid M. Sachs B. Comparative analysis of information provided in german adverse drug reaction reports sent by physicians, pharmacists and consumers. Drug Saf. 2023 46 12 1363 1379 10.1007/s40264‑023‑01355‑8 37987966
    [Google Scholar]
  62. Apte A. Reporting of adverse events for marketed drugs: Need for strengthening safety database. Perspect. Clin. Res. 2016 7 3 111 114 10.4103/2229‑3485.184781 27453826
    [Google Scholar]
  63. Routledge P.A. Bracchi R. Improving the spontaneous reporting of suspected adverse drug reactions: An overview of systematic reviews. Br. J. Clin. Pharmacol. 2023 89 8 2377 2385 10.1111/bcp.15791 37194555
    [Google Scholar]
  64. Arlett P.R. Kurz X. New approaches to strengthen pharmacovigilance. Drug Discov. Today. Technol. 2011 8 1 e15 e19 10.1016/j.ddtec.2011.03.003 24103839
    [Google Scholar]
  65. Getov I. Panayotova D. Dobrev S. Dimitrova M. Petkova V. Opportunities for implementing digital applications to monitor the impact of risk-minimization measures within the pharmacovigilance process: Scoping review of published literature. Pharmacia 2025 72 1 6 10.3897/pharmacia.72.e143323
    [Google Scholar]
  66. Edrees H. Song W. Syrowatka A. Simona A. Amato M.G. Bates D.W. Intelligent telehealth in pharmacovigilance: A future perspective. Drug Saf. 2022 45 5 449 458 10.1007/s40264‑022‑01172‑5 35579810
    [Google Scholar]
  67. Li R. Curtis K. Zaidi S.T. Van C. Castelino R. A new paradigm in adverse drug reaction reporting: Consolidating the evidence for an intervention to improve reporting. Expert Opin. Drug Saf. 2022 21 9 1193 1204 10.1080/14740338.2022.2118712 36031811
    [Google Scholar]
  68. Matlala M.F. Lubbe M.S. Steyn H. The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase®. Afr. J. Prim. Health Care Fam. Med. 2023 15 1 e1 e9 10.4102/phcfm.v15i1.3659 36744452
    [Google Scholar]
  69. Mlotshwa C.R.N. Burger J.R. Vorster M. Rakumakoe D.M. Cockeran M. Completeness of pharmaceutical industry insulin adverse event reports from Africa and the Middle East. Expert Opin. Drug Saf. 2023 22 3 221 229 10.1080/14740338.2022.2110863 35946933
    [Google Scholar]
  70. Vivekanandan K. Rishi K. Prasad T. Arunabh T. Singh G.N. Status of documentation grading and completeness score for Indian individual case safety reports. Indian J. Pharmacol. 2015 47 3 325 327 10.4103/0253‑7613.157133 26069373
    [Google Scholar]
  71. Humbert X. Chrétien B. Sassier M. Coquerel A. Alexandre J. Fedrizzi S. Evaluation of a new pharmacovigilance tool: Simplified online reporting for general practitioners. Santé Publique 2018 30 2 225 32
    [Google Scholar]
  72. Alduwaisan H. Electronic Incidence reporting impact on Quality and Patient Safety: Results of Quality Improvement Project at Yarmouk Health Care Center. 2023 Available from: http://www.mejfm.com/October%202023/Quality%20Improvement.htm [cited 2025 Feb 7].
  73. Soyer J. Necsoiu D. Desjardins I. Lebel D. Bussières J.F. Identification of discrepancies between adverse drug reactions coded by medical records technicians and those reported by the pharmacovigilance team in pediatrics: An intervention to improve identification, reporting, and coding. Arch. Pediatr. 2019 26 7 400 406 10.1016/j.arcped.2019.09.004 31611146
    [Google Scholar]
  74. Kumar R. Kumar P. Kalaiselvan V. Kaur I. Singh G.N. Best practices for improving the quality of individual case safety reports in pharmacovigilance. Ther. Innov. Regul. Sci. 2016 50 4 464 471 10.1177/2168479016634766 30227026
    [Google Scholar]
  75. S S. K B. P K. Audit to evaluate the completeness of adverse drug reporting in an ADR monitoring centre in Tamilnadu. Indian J. Med. Specialit. 2017 8 4 175 178 10.1016/j.injms.2017.05.001
    [Google Scholar]
/content/journals/cds/10.2174/0115748863339571250610103928
Loading
Enhancing Pharmacovigilance in Pharmaceutical Companies: A Comparative Study of Electronic Reporting Before and After Implementation
Bentham Science Publishers ; https://doi.org/10.2174/0115748863339571250610103928
/content/journals/cds/10.2174/0115748863339571250610103928
/content/journals/cds/10.2174/0115748863339571250610103928
Loading

Data & Media loading...


  • Article Type:     Research Article
Keywords: Adverse drug reaction reporting systems ; vigibase ; vigigrade ; E-reporting ; pharmaceutical companies ; E2B ; CIOMS ; post-marketing surveillance ; pharmacovigilance

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