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2005, Number 3

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Rev Med Inst Mex Seguro Soc 2005; 43 (3)

Pharmacovigilance IV. The Institutional Experience

Hernández SDL, Rodríguez BL, Jasso GL

Language: Spanish
References: 49
Page: 257-266
PDF size: 102.21 Kb.


ABSTRACT

The main purpose of this fourth paper of the phar-macovigilance series proposes to communicate the institutional experience during the year 2003 represented by 890 adverse drug reaction reports (ADRs) and to compare these with the international experience. The therapeutic drug classes more frequently included in these reports were antibiotic and antiparasitic drugs (38.2 %) followed by oncologic (17.7 %), analgesic (16.6 %), and car-diologic drugs (7.1 %), among others; the drug most frequently implicated in the reports was sulfamethoxazole-trimethoprim (12 %). In addition, we processed data ascertain the 10 drugs most frequently implicated in each therapeutic class, including vaccines and toxoid-group ADRs; using the body system-organ classification, the 20 clinical manifestations most frequently reported are presented herein, skin the most frequently affected organ (874 reports). In relation to severity of suspected adverse drug reactions reported, 68.7 % were mild, 26.4 % moderate, 3.9 % severe, and 0.8 %, lethal. This article also includes causality assessment results, quality of information contained in the reports, and patient consequences. After reviewing the results of both the International Drug Monitoring Programme and the Institutional Program during the year 2003, it is possible to conclude that comparisons are similar.


REFERENCES

  1. Rodríguez-Betancourt JL, García-Vigil JL, Giral-Barnés C, Hernández-Santillán D, Jasso-Gutiérrez L. Farmacovigilancia I. El inicio. Rev Med IMSS 2004;42(4):327-329.

  2. Rodríguez-Betancourt JL, García-Vigil JL, Giral-Barnés C, Hernández-Santillán D, Jasso-Gutiérrez L. Farmacovigilancia II. Las Reacciones adversas y el Programa Internacional de Monitoreo de los Medicamentos. Rev Med IMSS 2004:42(5):419-423.

  3. Rodríguez-Betancourt JL, García-Vigil JL, Giral-Barnés C, Hernández Santillán D, Jasso-Gutiérrez L. Farmacovigilancia III. La experiencia internacional. Rev Med

  4. IMSS 2005;43(2):131-140.

  5. Lawson DH. Epidemiology. En: Davies DM, editor. Textbook of adverse drug reactions. Oxford University Press, USA: Oxford Medical Publications; 1991. p. 5-17.

  6. Montastruc JL, Lapeyre M, Bagheri H, Fooladi A. Gender differences in adverse drug reactions: analysis of spontaneous reports to a Regional Pharmacovigilance

  7. Centre in France. Fundam Clin Pharmacol 2002;16(5):343-346.

  8. Hunziker T, Kunzi UP, Braunschweig S, Zehnder D, Hoigne R. Comprehensive hospital drug monitoring (CHDM): adverse skin reactions, a 20-year survey.

  9. Allergy 1997;52(4):388-393.

  10. Wasserfallen J, Livio F, Buclin T, Tillet l, Yersin B, Biollaz J. Rate, type, and cost of adverse drug reactions in emergency department admissions. Record Supplied

  11. By Publisher 2001;12(5):442-447.

  12. Schoenemann J, Munter KH, Enayati-Kashani S. Unwanted drug effects in clinical practice. Dtsch Med Wochenschr 1998;123(15):448-452.

  13. Teweleit S, Kuschel U, Hippius M, Goettler M, Bornschein B. Manifestation and prevention of adverse drug reactions ADR in the pharmacotherapy of cardiovascular diseases. Med Klin Munich 2001; 96(8):442-450.

  14. Zaidenstein R, Eyal S, Efrati S, Akivison L, Michowitz MK, Nagomov V, et al. Adverse drug events in hospitalized patients treated with cardiovascular drugs and

  15. anticoagulants. Pharmacoepidemiol Drug Saf 2002;11(3):235-238.

  16. Carrasco-Garrido P, Gallardo-Pino C, Jiménez-García R, Tapias MA, De Miguel AG. Incidence of adverse reactions to vaccines in a pediatric population. Clin

  17. Drug Invest 2004;24(8):457-463.

  18. Queneau P, Bannwarth B, Carpentier F, Guliana JM, Bouget J, Trombert B, et al. Adverse drug effects observed at French admissions departments and emergency services. Prospective Study of the National Educational Association for Teaching Therapeutics and Proposals for Preventive Measures. Bull Acad Natl Med 2003;187(4):647-666.

  19. Morales-Olivas FJ, Martínez-Mir I, Ferrer JM, Rubio E, Palop V. Adverse drug reactions in children reported by means of the yellow card in Spain. J Clin Epidemiol 2000;53(10):1076-1080.

  20. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a metaanalysis of prospective studies. JAMA 1998;279(15):

  21. 1200-1205.

  22. Chyka PA. How many deaths occur annually from adverse drug reactions in the United States? AM J Med 2000;109(2):122-130.

  23. Larry G, Thornton GF, Smith JW, Leighton E. Studies on the epidemiology of adverse drug reactions III. Methods of surveillance. JAMA 1966; 299-315.

  24. Macedo AF, Marques FB, Ribeiro CF, Teixeira F. Causality assessment of adverse drug reactions: comparison of the results obtained from published decisional algorithms and from the evaluations of an expert panel, according to different levels of imputability. J Clin Pharm Ther 2003;28(2):137-143.

  25. Olivier P, Boulbes O, Tubery M, Lauque D, Montastruc JL, Lapeyre M. Assessing the feasibility of using an adverse drug reaction preventability scale in clinical

  26. practice: a study in French emergency department. Drug Saf 2002;25(14):1035-1044.

  27. Green CT, Mottram DR, Rowe PH, Pirmohamed M. Adverse drug reactions as a cause of admission to an acute medical assessment unit: a pilot study. J Clin

  28. Pharm Ther 2000;25(5):355-361.

  29. Gautier S, Bachelet H, Bordet R, Caron J. The cost of adverse drug reactions. Expert Opin Pharmacother 2003;4(3):319-326.

  30. Rodríguez-Betancourt JL, García-Vigil JL, Giral-Barnés C, Hernández-Santillán D, Jasso-Gutiérrez L. Farmacovigilancia I. El inicio. Rev Med IMSS 2004;42(4):327-329.

  31. Rodríguez-Betancourt JL, García-Vigil JL, Giral-Barnés C, Hernández-Santillán D, Jasso-Gutiérrez L. Farmacovigilancia II. Las Reacciones adversas y el Programa Internacional de Monitoreo de los Medicamentos. Rev Med IMSS 2004:42(5):419-423.

  32. Rodríguez-Betancourt JL, García-Vigil JL, Giral-Barnés C, Hernández Santillán D, Jasso-Gutiérrez L. Farmacovigilancia III. La experiencia internacional. Rev Med IMSS 2005;43(2):131-140.

  33. Lawson DH. Epidemiology. En: Davies DM, editor. Textbook of adverse drug reactions. Oxford University Press, USA: Oxford Medical Publications; 1991. p. 5-17.

  34. Montastruc JL, Lapeyre M, Bagheri H, Fooladi A. Gender differences in adverse drug reactions: analysis of spontaneous reports to a Regional Pharmacovigilance Centre in France. Fundam Clin Pharmacol 2002;16(5):343-346.

  35. Hunziker T, Kunzi UP, Braunschweig S, Zehnder D, Hoigne R. Comprehensive hospital drug monitoring (CHDM): adverse skin reactions, a 20-year survey. Allergy 1997;52(4):388-393.

  36. Wasserfallen J, Livio F, Buclin T, Tillet l, Yersin B, Biollaz J. Rate, type, and cost of adverse drug reactions in emergency department admissions. Record Supplied By Publisher 2001;12(5):442-447.

  37. Schoenemann J, Munter KH, Enayati-Kashani S. Unwanted drug effects in clinical practice. Dtsch Med Wochenschr 1998;123(15):448-452.

  38. Teweleit S, Kuschel U, Hippius M, Goettler M, Bornschein B. Manifestation and prevention of adverse drug reactions ADR in the pharmacotherapy of cardiovascular diseases. Med Klin Munich 2001; 96(8):442-450.

  39. Zaidenstein R, Eyal S, Efrati S, Akivison L, Michowitz MK, Nagomov V, et al. Adverse drug events in hospitalized patients treated with cardiovascular drugs and anticoagulants. Pharmacoepidemiol Drug Saf 2002;11(3):235-238.

  40. Carrasco-Garrido P, Gallardo-Pino C, Jiménez-García R, Tapias MA, De Miguel AG. Incidence of adverse reactions to vaccines in a pediatric population. Clin Drug Invest 2004;24(8):457-463.

  41. Queneau P, Bannwarth B, Carpentier F, Guliana JM, Bouget J, Trombert B, et al. Adverse drug effects observed at French admissions departments and emergency services. Prospective Study of the National Educational Association for Teaching Therapeutics and Proposals for Preventive Measures. Bull Acad Natl Med 2003;187(4):647-666.

  42. Morales-Olivas FJ, Martínez-Mir I, Ferrer JM, Rubio E, Palop V. Adverse drug reactions in children reported by means of the yellow card in Spain. J Clin Epidemiol 2000;53(10):1076-1080.

  43. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a metaanalysis of prospective studies. JAMA 1998;279(15): 1200-1205.

  44. Chyka PA. How many deaths occur annually from adverse drug reactions in the United States? AM J Med 2000;109(2):122-130.

  45. Larry G, Thornton GF, Smith JW, Leighton E. Studies on the epidemiology of adverse drug reactions III. Methods of surveillance. JAMA 1966; 299-315.

  46. Macedo AF, Marques FB, Ribeiro CF, Teixeira F. Causality assessment of adverse drug reactions: comparison of the results obtained from published decisional algorithms and from the evaluations of an expert panel, according to different levels of imputability. J Clin Pharm Ther 2003;28(2):137-143.

  47. Olivier P, Boulbes O, Tubery M, Lauque D, Montastruc JL, Lapeyre M. Assessing the feasibility of using an adverse drug reaction preventability scale in clinical practice: a study in French emergency department. Drug Saf 2002;25(14):1035-1044.

  48. Green CT, Mottram DR, Rowe PH, Pirmohamed M. Adverse drug reactions as a cause of admission to an acute medical assessment unit: a pilot study. J Clin Pharm Ther 2000;25(5):355-361.

  49. Gautier S, Bachelet H, Bordet R, Caron J. The cost of adverse drug reactions. Expert Opin Pharmacother 2003;4(3):319-326.




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