nach oben

Drug Safety

Erschienen in:

01.08.2006 | Original Research Article

Can Decisional Algorithms Replace Global Introspection in the Individual Causality Assessment of Spontaneously Reported ADRs?

verfasst von: Dr Ana F. Macedo, Francisco B. Marques, Carlos F. Ribeiro

Erschienen in: Drug Safety | Ausgabe 8/2006

Einloggen, um Zugang zu erhalten

Abstract

Aim: The usefulness of algorithms for assessing the causality of suspected adverse drug reactions (ADRs) has yet to be established and, since the validation of causality algorithms depends upon their sensitivity and specificity, our study was carried out to evaluate these measures.

Method: In this study, an expert panel assessed causality of adverse reports by using the WHO global introspection (GI) method. The same reports were independently assessed using 15 published algorithms. The causality assessment level ‘possible’ was considered the lower limit for a report to be considered to be drug related. For a given algorithm, sensitivity was determined by the proportion of reports simultaneously classified as drug related by the algorithm and the GI method. Specificity was measured as the proportion of reports simultaneously considered non-drug related. The analysis was performed for the total sample and within serious or unexpected events.

Results: Five hundred adverse reports were studied. Algorithms presented high rates of sensitivity (average of 93%, positive predictive value of 89%) and low rates of specificity (average of 7%, negative predictive value of 31%).

Conclusion: Decisional algorithms are sensitive methods for the detection of ADRs, but they present poor specificity. A reference method was not identified. Algorithms do not replace GI and are not definite alternatives in the individual causality assessment of suspected ADRs.

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998; 279(15): 1200–5PubMedCrossRef

Einarson TR. Drug related hospital admissions. Ann Pharmacother 1993; 27: 832–40PubMed

Muehlberger N, Schneeweiss S, Hasford J. Adverse drug reaction monitoring - cost and benefit considerations. Part I: frequency of adverse drug reactions causing hospital admissions. Pharmacoepidemiol Drug Saf 1997; 6Suppl. 3: S71–7PubMedCrossRef

Classen DC, Pestotnik SL, Evans RS, et al. Adverse drug events in hospitalized patients: excess length of stay, extra costs and attributable mortality. JAMA 1997; 277(4): 301–6PubMedCrossRef

Moore N, Lecointre D, Noblet C, et al. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol 1998; 45: 301–8PubMedCrossRef

Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse drug events and negligence in hospitalized patients: results of the Harvard medical practice study I. N Engl J Med 1991; 324(6): 370–6PubMedCrossRef

Dormann H, Muth-Selbach U, Krebs S, et al. Incidence and costs of adverse drug reactions during hospitalisation. Drug Saf 2000; 22(2): 161–8PubMedCrossRef

Vincent C, Neale G, Wolhynowych M. Adverse events in British hospitals: preliminary retrospective record review. BMJ 2001; 322: 517–9PubMedCrossRef

Winterstein AG, Sauer BC, Hepler CD, et al. Preventable drug-related hospital admissions. Ann Pharmacother 2002; 36: 1238–48PubMedCrossRef

10.

Karch FE, Smith CL, Kerzner B, et al. Adverse drug reactions a matter of opinion. Clin Pharmacol Ther 1976; 19: 489–92PubMed

11.

Blanc S, Levenberger P, Berger JP, et al. Judgements of trained observers on adverse drug reactions. Clin Pharmacol Ther 1979; 25: 493–8PubMed

12.

Karch FE, Lasagna L. Toward the operational identification of adverse drug reactions. Clin Pharmacol Ther 1977; 21: 247–54PubMed

13.

Venulet J. Aspects of standardization as applied to the assessment of drug-event associations. Drug Inf J 1984; 18(3/4): 199–210PubMed

14.

Hutchinson TA, Flegel KM, Herbert H, et al. Reasons for disagreement in the standardized assessment of suspected adverse drug reactions. Clin Pharmacol Ther 1983; 34: 421–6PubMedCrossRef

15.

Dangoumau J, Begaud B, Boisseau A, et al. Methods for identification and imputation of drug side effects. Side effects: a fleeing reality, an illusive reality? [in French]. Therapie 1980; 35: 287–92PubMed

16.

Begaud B, Boisseau A, Albin H, et al. Comparaison de quatre méthodes d’imputabilité des effets indésirables des médicaments. Therapie 1981; 36: 65–70PubMed

17.

Leroy O, Begaud B, Dangoumau J, et al. Etude comparative de quatre méthodes d’imputabilité. Therapie 1981; 36: 223–7PubMed

18.

Pere JC, Begaud B, Haramburu F, et al. Computerized comparison of six adverse drug reactions assessment procedures. Clin Pharmacol Ther 1986; 40: 451–61PubMedCrossRef

19.

Girard M. L’imputation en pharmacovigilance est-elle fiable? Therapie 1984; 39: 291–6PubMed

20.

Pere JC, Begaud B, Haramburu F, et al. Méthodes d’étude des effets indésirables des medicaments: II. Profil et comparaison de cinq méthodes d’imputabilité. Therapie 1984; 39: 369–78PubMed

21.

Frick PA, Cohen LG, Rovers JP. Algorithms used in adverse drug event reposts: a comparative study. Ann Pharmacother 1997; 31: 164–7PubMed

22.

Michel DJ, Knodel LC. Comparison of three algorithms used to evaluate adverse drug reactions. Am J Hosp Pharm 1986; 43: 1709–14PubMed

23.

Bate A, Lindquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol 1998; 54: 315–21PubMedCrossRef

24.

Lindquist M, Edwards IR, Bate A, et al. From association to alert -a revised approach to international signal analysis. Pharmacoepidemiol Drug Saf 1999; 8: S15–25PubMedCrossRef

25.

van Puijenbroek E, Diemont W, van Grootheest K. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions. Drug Saf 2003; 26(5): 293–301PubMedCrossRef

26.

van Puijenbroek EP, Bate A, Leufkens HG, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf 2002; 11: 3–10PubMedCrossRef

27.

Macedo AF, Marques FB, Ribeiro CF, et al. 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 Pharmacol Ther 2003; 28: 137–43CrossRef

28.

Macedo AF, Marques FB, Ribeiro CF, et al. Causality assessment of adverse drug reactions: comparison of the results obtained from published decisional algorithms and from the evaluations of an expert panel. Pharmacoepidemiol Drug Saf 2005; 14: 885–90PubMedCrossRef

29.

Mashford ML. The Australian method of drug-event assessment. Drug Inf J 1984; 18: 271–3PubMed

30.

Stephens MD. The diagnosis of adverse medical events associated with drug treatment. Adverse Drug React Acute Poisoning Rev 1987; 1: 1–35

31.

Dangoumau J, Evreux JC, Jouglard J. Méthode d’imputabilité des effets indésirables des médicaments. Therapie 1978; 33: 373–81PubMed

32.

Begaud B, Evreux JLC, Jouglard JC, et al. Imputabilité des effets inattendus ou toxiques des médicaments: actualisation de la méthode utilisée en France. Therapie 1985; 40: 111–4PubMed

33.

Emanueli A. A simple algorithm for assessing causality of adverse reactions. Special Workshop-Industrial. Drug Inf J 1984; 18: 303–6

34.

Hsu P-H, Stoll RW. Causality assessment of adverse events in clinical trials: II. an algorithm for drug causality assessment. Drug Inf J 1993; 27: 387–94CrossRef

35.

Irey NS. Tissue reactions to drugs. Am J Pathol 1976; 82: 617–48

36.

Jones JK. Adverse drug reactions in the community health setting: approaches to recognizing, counselling and reporting. Fam Community Health 1982; 5(2): 58–67PubMed

37.

Kitaguchi T, Nojiri T, Suzuki S, et al. Some assessment systems for industry post marketing adverse drug reaction (ADR) information. Iyakuhin Kenkyu 1983; 14: 980–93

38.

Kramer MS, Leventhal JM, Hutchinson TA, et al. An algorithm for the operational assessment of adverse drug reactions: I. Background, description and instructions for use. JAMA 1979; 242: 623–32PubMedCrossRef

39.

Hutchinson TA, Leventhal JM, Kramer MS, et al. An algorithm for the operational assessment of adverse drug reactions: II. Demonstration of reproducibility and validity. JAMA 1979; 242: 633–8PubMedCrossRef

40.

Leventhal JM, Hutchinson TA, Kramer MS, et al. An algorithm for the operational assessment of adverse drug reactions: III. Results of tests among clinicians. JAMA 1979; 242: 1991–4PubMedCrossRef

41.

Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239–45PubMedCrossRef

42.

Stephens MD. Assessment of causality in industrial setting. Special Workshop-Industrial. Drug Inf J 1984; 18: 307–13

43.

Venulet J, Ciucci A, Berneker GC. Updating of a method for causality assessment of adverse drug reactions. Int J Clin Pharmacol Ther Toxicol 1986; 24: 559–68PubMed

44.

Weber JCP. Storage and retrieval of data on adverse reactions to drugs. Brighton: Interphex Symposium, 1980

45.

Causality assessment of suspected adverse drug reaction. WHO-UMC [online]. Available from URL: http://www.whoumc.org/DynPage.aspx?.id = 22682 [Accessed 2006 Jan31]

46.

World Health Organization criteria for serious adverse event or reaction [online]. Available from URL: http://www.whoumc.org/DynPage.aspx?.id = 22680 [Accessed 2006 Jan 31]

47.

Parfitt K. Martindale: the complete drug reference. 32nd ed. Grayslake (IL): Pharmaceutical Press. 1999

48.

Stahl M, Lindquist M, Edwards IR, et al. Introducing triage logic as a new strategy for the detection of signals in the WHO Drug Monitoring Database. Pharmacoepidemiol Drug Saf 2004; 13: 355–63PubMedCrossRef

Titel: Can Decisional Algorithms Replace Global Introspection in the Individual Causality Assessment of Spontaneously Reported ADRs?
verfasst von: Dr Ana F. Macedo
Francisco B. Marques
Carlos F. Ribeiro
Publikationsdatum: 01.08.2006
Verlag: Springer International Publishing
Erschienen in: Drug Safety / Ausgabe 8/2006
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI: https://doi.org/10.2165/00002018-200629080-00006

Die Highlights vom Kongress des American College of Cardiology 2024

Springer Medizin

Can Decisional Algorithms Replace Global Introspection in the Individual Causality Assessment of Spontaneously Reported ADRs?

Abstract

Die Highlights vom Kongress des American College of Cardiology 2024

Springer Medizin

Abstract

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 8/2006

An Industry Perspective on the Erice Declaration and Risk Minimisation Plans

Safety of Etanercept in Psoriasis

Long-Acting β2-Agonists in Asthma

Effect of Ezetimibe and/or Simvastatin on Coenzyme Q10 Levels in Plasma

Clinical Risk Management in Dutch Community Pharmacies

Serious Skin Reactions and Selective COX-2 Inhibitors