Abstract
Once the decision has been taken as to the type of adverse event to be collected, a form should be designed for the recording of the data (see Chapter 8). Where the data is recorded by the presence or absence of a stated event (i.e. questionnaire or checklist) and the trial is a large controlled trial, it is necessary to compare the two drugs statistically rather than to try to assess each event as to its causality by the drug. Where the event is more than the transient appearance of a mild to moderate non-serious symptom, then a judgment needs to be made as to its causality and this applies to both controlled and uncontrolled studies. It is very rare that a drug can be indicted as the “complete and definite cause” of a particular adverse event without any reservations and almost as rare to be able to clear a drug of being a factor in an adverse event. The causality is, therefore, a question of opinion.
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References
Karch, F.E., Smith, C.L., Keizner, B., Mazzulo, J.M., Weintraub, M. and Lasagna, L. Adverse drug reactions — a matter of opinion. Clin. Pharmacol. Ther., 1976, 19 (S, Pt 1), 489–492
Blanc, S., Leuenberger, P., Berger, J.–P., Brooks, E.M. and Schelling, J.–L. Judgment of trained observers on adverse drug reactions. Clin. Pharmacol. Ther., 1979, 25 (3), 493–498
Koch-Weser, J., Sellers, E.M. and Zacest, R. The ambiguity of adverse drug reactions. Eur. J. Clin. Pharmacol., 1977, 11, 75–78
Berger, J. P., Haller, E., Blanc, S., Brooks, E.M. and Schelling, J.–L. Quelques facteurs intervenant dans les réactions adverses mésdicamenteuses. Schweiz. Med. Wochenschr. 1975, 105 (50), 1706–1708
Dangoumau, J., Begaud, B., Boisseau, A. and Albin, H. Les effets indésirablesdes médicaments. Diagnostics comparés de clinicians et pharmacoloques cliniciens. Nouv. Presse Med., 1980, 9 (23), 1607–1609
Kramer, M.S. Difficulties in assessing the adverse effects of drugs. Br. J. Clin. Pharmacol., 1981, 11, 105S–110S
Dangoumau, J., Evreux, J.-C. and Jouglard, J. Méthode d’imputabilité des effets indésirables des médicaments. Thérapie, 1978, 33, 373–381
Begaud, B., Boisseau, A., Albin, H. and Dangoumau, J. Imputabilitédes effets indesirables des médicaments. Etude de 194 observations. Thérapie, 1978, 33, 383–389
Karch, F.E. and Lasagna, L. Toward the operational identification of adverse drug reactions. Clin. Pharmacol. Ther., 1977, 21 (3), 247–253
Lapedes, D.N. (Ed.). Dictionary of Scientific and Technical Terms, McGraw-Hill, 1978
Irey, N.S. Tissue reactions to drugs. Am. J. Pathol., 1976, 82 (3), 617–647
Irey, N.S. Diagnostic problems in drug-induced diseases. In Drug-induced Diseases, Vol. 4 (ed. L. Meyler and H. Pek), Excerpta Medica, Amsterdam, 1972, pp.1–24
Farina, J.C., Krupp, P. and Tobler, H.J. Computer tools in spontaneous reporting of adverse drug reactions — A multinational approach. In Computer Aid to Drug Therapy and to Drug Monitoring (ed. Ducrot et al.), North-Holland, 1978, pp.117–123
Pére, J.C., Begaud, B., Albin, H. and Dangoumau, J. Effets indésirables non-décrits de l’observation aux données de la litérature. Thérapie, 1981, 36, 237–240
Weber, J. C. P. Storage and retrieval of data on adverse reactions to drugs. Interphex Symposium, Brighton, 10–13 June 1980
Jones, J.K. Revised causality algorithm, November 1980. Procedural Manual for handling drug experience reports, FDA
Hutchinson, T. A., Leventhal, J. M., Kramer, M. S., Karch, F.E., Lipman, A.G. and Feinstein, A.R. An algorithm for the operational assessment of adverse drug reactions, II:
Demonstration of reproducibility and validity. J.A.M.A., 1979, 242 (7), 633–638
Leventhal, J.M., Hutchinson, T.A., Kramer, M.S. and Feinstein, A.R. An algorithm for the operational assessment of adverse drug reactions, III: Results of tests among clinicians. J.A.M.A., 1979, 242 (18), 1991–1994
Venulet, J., Ciucci, A. and Berneker, G.C. Standardized assessment of drug-adverse reaction associations — rationale and experience. Int. J. Clin. Pharmacol. Ther. Toxicol., 1980, 18 (9), 381–388
Naranjo, C.A., Busto, U., Sellers, E.M. et al. A method for estimating the probability of adverse drug reactions. Clin. Pharmacol. Ther., 1981, 30, 239–245
Busto, U., Naranjo, G.A. and Sellers, E.M. Comparison of two recently published algorithms for assessing the probability of adverse drug reactions. Br. J. Clin. Pharmacol., 1982, 13, 112–117
Emanueli, A. and Sacchetti, G. An algorithm for the classification of untoward events in large scale clinical trials. In Agents and Actions, Vol. 7, Berkhäuser Verlag, Basle, 1980, pp.318–322
Report of Suspected Adverse Drug Reactions No. 4. Australian Government Publication Service, Canberra, 1978, p.v
Venning, G.R. Validity of anecdotal reports of suspected adverse drug reactions and the problems of false alarms. Br. Med. J., 1982, 284, 249
Maistrello, I., Grassi, G., Bertolino, A., Valerio, P., Pistollato, G. and Soverini, S. Unwanted symptoms in depressed patients treated with viloxazine: an algorithm for identification of illness-related symptoms. Eur. J. Clin. Pharmacol., 1983, 24 Feb., 277–281
Dangoumau, J., Begaud, B., Boisseau, A. and Albin, H. Méthodes d’identification et d’imputabilité des effets indesirables des médicaments. Thérapie, 1980, 35, 287–292
Leroy, O., Begaud, B., Dangournau, J., Peytour, P. and Salamon, R. Etude comparative de quatre méthodes d’imputabilité. Thérapie, 1981, 36, 223–227
Begaud, B., Boisseau, A., Albin, H. and Dangoumau, J. Comparaison de quatre méthodes d’imputabilité des effets indesirables des médicaments. Thérapie, 1981, 31 (1), 65–70
Begaud, B., Haramburu, F., Pére, J. C. and Dangoumau, J. Les critéres d’imputabilité confrontés á la pratique á propos de 1000 observations. Thérapie, 1982, 37, 415–420
Salamon, R. and Peytour, P. Recherche du poids des critéres dans un algorithme d’imputabilité. Thérapie, 1981, 36, 229–231
Dangoumau, J., Begaud, B., Pére, J. C. and Albin, H. De 1’imputabilité originelle á 1’imputabilité terminal. Thérapie, 1981, 361, 219–227
Boisseau, A., Begaud, B., Albin, H. and Dangoumau, J. Réevaluation du diagnostic d’effets indésirables des médicaments avec un recul de six mois. Thérapie, 1980, 35, 577–580
Dangoumau, J., Begaud, B., Boisseau, A. and Albin, H. Mdthodes d’ identificationde 1’imputabilité des effets indesirables des médicaments. L’effect indesirable, une realité fuyante? Thérapie, 1980, 35, 287–292
Prichard, B.N.C. Hypotensive action of Pronethalol. Br. Med. J., 1964, 1, 1227–1228
Baumelou, A. and Legrain, M. Medical nephrectomy with antiinflammatory non-steroidal drugs. Br. Med. J., 1982, 284, 234
Gagnon, M.-A. Subjective phenomena in drug trials. Int. J. Clin. Pharmacol., 1977, 15 (4), 155–160
McPherson, K., Healey, M. J. R., Flynn, F.V. and Piper, K.A.J. The effect of age, sex and other factors on blood chemistry in health. Clin. Chim. Acta, 1978, 84, 373–397
Presentation of Observed Values. Part 6: The Theory of Reference Values, I.F.C.C. Document 1982 (Stages 1 and 2), 1982, 7, 27
Ciccolunghi, S.M., Fowler, P.D. and Chaudri, M.J. Interpretation of haematological and biochemical laboratory data in large-scale multicentre clinical trials. J. Clin. Pharmacol., 1979, 19, 302–312
Pitts, N.E. Prazosin -- Evaluation of a New Hypertensive Agent, International Congress Series No. 331, Excerpta Medica, Amsterdam, 1974, p.159
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© 1985 M.D.B. Stephens
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Stephens, M.D.B. (1985). The Assessment of Adverse Medical Events. In: The Detection of New Adverse Drug Reactions. Palgrave Macmillan, London. https://doi.org/10.1007/978-1-349-07250-7_3
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DOI: https://doi.org/10.1007/978-1-349-07250-7_3
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