Impact of Geographic and Cross-Cultural Differences on Spontaneous Adverse Events Reporting


A study was conducted to explore the potential difference in geographic and cross-cultural variation in safety adverse drug reaction reporting. Attempts were made in the study design to minimize genetic differences, market representation, age, and gender as confounding factors in affecting the findings. Six thousand spontaneous reports from five countries (France, Germany, United Kingdom, United States, and Canada) were randomly generated from our spontaneous safety database which covered a 15-year reporting period (March 1, 1983 to December 31, 1997). The reports were then reviewed and compared against each country for several factors of interest. Despite some limitations, there are interesting observations from the current study that are worth further review. For example, German reports seem more likely to be serious, related to death and life-threatening events, and may warrant more attention. The Canadian and American reports had the highest numbers in the category of lack of drug effect. When further analyzed using continent rather than country as a base, Europe was consistently higher in terms of number of serious reports, death/life-threatening events, and cases of overdose. The current study is limited to our experience and further research by other investigators to confirm these findings is warranted.

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  1. 1.

    Johnson JM, Tanner LA. Postmarketing surveil-lance: curriculum for the clinical pharmacologist. Part [[: Clinical and regulatory considerations. J Clin Pharmacol. 1993;33:1015–1022.

    CAS  Article  Google Scholar 

  2. 2.

    Piazza-Hepp TD, Kennedy DL. Reporting of ad-verse events to MedWatch. Am J Health-System Pharm. 1995;52:1436–1439.

    CAS  Article  Google Scholar 

  3. 3.

    Rossi AC, Knapp DE. Discovery of new adverse drug reactions: a review of the Hood and Drug Administration’s spontaneous reporting system. JAMA. 1984;252:1030–1033.

    CAS  Article  Google Scholar 

  4. 4.

    Sills JM, Tanner JA, Milstien JM. Food and Drug Administration monitoring of adverse drug reactions. Am J Hosp Pharm. 1986;43:2764–2770.

    CAS  PubMed  Google Scholar 

  5. 5.

    Strom BL, Melmon KL. Can postmarketing surveillance help to effect optimal drug therapy? JAMA. 1979;242:2420–2423.

    CAS  Article  Google Scholar 

  6. 6.

    Lortie FM. Postmarketing surveillance of adverse drug reactions: problems and solutions. Canadian Med Assoc J. 1986;135:27–32.

    CAS  Google Scholar 

  7. 7.

    Moore N, Biour M, Paux G, et al. Adverse drug reaction monitoring: doing it the French way. Lancet. 1985;2:1056–1058.

    CAS  Article  Google Scholar 

  8. 8.

    Litovitz T. The TESS database. Use in product safety assessment. Drug Safety. 1998;18:9–19.

    CAS  Article  Google Scholar 

  9. 9.

    Finney DJ. The detection of adverse reactions to therapeutic drugs. Stat Med. 1982;1:153–161.

    CAS  Article  Google Scholar 

  10. 10.

    Rossi AC, Bosco L, Faich GA, Tanner LA. The importance of adverse reaction reporting by physicians. JAMA. 1988;259:1203–1204.

    CAS  Article  Google Scholar 

  11. 11.

    Clark JA. Zimmerman HJ, Tanner LA. Labetalol hepatotoxicity. Ann Intern Med. 1990;113:210–213.

    CAS  Article  Google Scholar 

  12. 12.

    Green L, Clark J. Fluoroquinolones and theophylline toxicity: Norfloxacin. JAMA. 1989:262:2383.

    CAS  Article  Google Scholar 

  13. 13.

    Jolson H, Tanner LA, Green L. Adverse reaction reporting of interactions between warfarin and fluoroquinolones. Arch Intern Med. 1991;151:1003–1004.

    CAS  Article  Google Scholar 

  14. 14.

    Belton KJ. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. The European Pharmacovigilance Research Group. European J Clin Pharmacol. 1997;52:423–427.

    CAS  Article  Google Scholar 

  15. 15.

    Cosentino M, Leoni O, Banfi F, Lecchini S, Frigo G. Attitudes to adverse drug reaction reporting by medical practitioners in a Northern Italian district. Pharmacolog Res. 1997;35:85–88.

    CAS  Article  Google Scholar 

  16. 16.

    Bateman DN, Sanders GL, Rawlins MD. Attitudes to adverse drug reaction reporting in the Northern Region. Br J Clin Pharmacol. 1992;34:421–426.

    CAS  Article  Google Scholar 

  17. 17.

    Generali JA, Danish MA, Rosenbaum SE. Knowledge of and attitudes about adverse drug reaction reporting among Rhode Island pharmacists. Ann Pharmacother. 1995;29:365–369.

    CAS  Article  Google Scholar 

  18. 18.

    Brenner MH. Economic change, alcohol consumption and heart disease mortality in nine industrialized countries. Soc Sci Med. 1987;25:119–132.

    CAS  Article  Google Scholar 

  19. 19.

    Griffin JP. Survey of the spontaneous adverse drug reaction reporting schemes in fifteen countries. Br J Clin Pharmac. 1986;22(supplement):83S–100S.

    Article  Google Scholar 

  20. 20.

    Melnychuk D, Monde Y, Abenhaim L. Monitoring of drug utilization in public health surveillance activities: a conceptual framework. Can J Public Health. (Revue Canadienne de Sante Publique) 1993;84:45–49.

    CAS  PubMed  Google Scholar 

  21. 21.

    Albengres E. Features of the French postmarketing drug surveillance system. Application to cutaneous effects of nonsteroidal antiinflammatory drugs. J Rheumatol. 1988;17(supplement):20–23.

    CAS  Google Scholar 

  22. 22.

    Albengres E, Gauthier F, Tillement JP. Current French system of post-marketing drug surveillance. Int J Clin Pharmacol, Therapy, Toxicol. 1990;28:312–314.

    CAS  Google Scholar 

  23. 23.

    Kapp JF, Zentgraf R, Widmer A, Schopf E. A need to intensify drug surveillance in Germany. Klinische Wochenschrift. 1991;69:775–779.

    CAS  Article  Google Scholar 

  24. 24.

    Bern JL, Breckeridge AM, Mann Rd, Rawlins MD. Review of yellow cards (1986): report to the committee on the safety of medicines. Br J Clin Pharmac. 1988;26:679–689.

    Article  Google Scholar 

  25. 25.

    Smith CC, Bennett PM, Pearce Hm, et al. Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br J Clin Pharmacol. 1996;42:423–429.

    CAS  Article  Google Scholar 

  26. 26.

    van Boxtel CJ, Wang G. Some observations on pharmacoepidemiology in Europe. Netherlands J Med. 1997;51:205–212.

    Article  Google Scholar 

  27. 27.

    Richard BW, Lasagna L. Drug regulation in the United States and the United Kingdom: the Depo-Provera story. Ann Int Med. 1987;106:886–891.

    CAS  Article  Google Scholar 

  28. 28.

    Baum C, Kennedy DL, Forbes MB, Jones JK. Drug use in the United States in 1981. JAMA. 1984;251:1293–1297.

    CAS  Article  Google Scholar 

  29. 29.

    Raehl CL, Bond CA, Pitterle ME. Pharmaceutical services in U.S. hospitals in 1989. Am J Hosp Pharm. 1992;49:323–346.

    CAS  PubMed  Google Scholar 

  30. 30.

    O’Neil CK, Poirer TI. Impact of patient knowledge, patient-pharmacist relationship, and drug perceptions on adverse drug therapy outcomes. Pharmacother. 1998;18:333–340.

    Google Scholar 

  31. 31.

    Poulton BC. Use of the consultation satisfaction questionnaire to examine patients’ satisfaction with general practitioners and community nurses: reliability, replicability and disciminant validity. Br J General Practice. 1996;46:26–31.

    CAS  Google Scholar 

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Correspondence to Dr. Man Fung MD, MBA, FACP.

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Wu, HH., Fung, M., Hornbuckle, K. et al. Impact of Geographic and Cross-Cultural Differences on Spontaneous Adverse Events Reporting. Ther Innov Regul Sci 33, 921–931 (1999).

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Key Words

  • Spontaneous reporting system
  • Pharmacovigilance
  • Cross-cultural differences
  • Safety adverse event reporting