An Algorithm for the Operational Assessment of Adverse Drug Reactions

作者: Michael S. Kramer

DOI: 10.1001/JAMA.1979.03300070019017

关键词: MedicineDrugInstructions for useClinical manifestationAlgorithmMEDLINEDechallengeDrug reactionCausationRanking (information retrieval)

摘要: Despite widespread clinical and epidemiologic attention to adverse drug reactions (ADRs), their identification has been a nonreproducible act of unspecified subjective judgment; adequate operational criteria have not available for diagnostic decisions about the cause an observed untoward manifestation. To improve scientific precision in diagnosis ADRs, we developed algorithm that provides detailed ranking probability causation when ADR is suspected between The scoring system six axes decision strategy: previous general experience with drug, alternative etiologic candidates, timing events, levels evidence overdose, dechallenge, rechallenge. sum scores ordinally partitioned rate candidate as definite, probable, possible, or unlikely. (JAMA242:623-632, 1979)

参考文章(18)
Alvan R. Feinstein, XXVIII. The biostatistical problems of pharmaceutical surveillance Clinical Pharmacology & Therapeutics. ,vol. 16, pp. 110- 123 ,(1974) , 10.1002/CPT1974161PART1110
McCrae E, Kellaway Gs, Intensive monitoring for adverse drug effects in patients discharged from acute medical wards. The New Zealand Medical Journal. ,vol. 78, pp. 525- ,(1973)
Bette S. Bennett, Arthur G. Lipman, Comparative study of prospective surveillance and voluntary reporting in determining the incidence of adverse drug reactions American Journal of Health-system Pharmacy. ,vol. 34, pp. 931- 936 ,(1977) , 10.1093/AJHP/34.9.931
J. Koch-Weser, E. M. Sellers, R. Zacest, The ambiguity of adverse drug reactions. European Journal of Clinical Pharmacology. ,vol. 11, pp. 75- 78 ,(1977) , 10.1007/BF00562895
N. Hurwitz, O. L. Wade, Intensive Hospital Monitoring of Adverse Reactions to Drugs BMJ. ,vol. 1, pp. 531- 536 ,(1969) , 10.1136/BMJ.1.5643.531
George J. Caranasos, Drug-Induced Illness Leading to Hospitalization JAMA: The Journal of the American Medical Association. ,vol. 228, pp. 713- 717 ,(1974) , 10.1001/JAMA.1974.03230310023021
Larry Gilbert Seidl, George F. Thornton, Leighton E. Cluff, Epidemiological Studies of Adverse Drug Reactions American Journal of Public Health and the Nations Health. ,vol. 55, pp. 1170- 1175 ,(1965) , 10.2105/AJPH.55.8.1170
Robert B. Talley, Drug-Induced Illness JAMA: The Journal of the American Medical Association. ,vol. 229, pp. 1043- 1043 ,(1974) , 10.1001/JAMA.1974.03230460011003
Jane Porter, Drug-Related Deaths Among Medical Inpatients JAMA: The Journal of the American Medical Association. ,vol. 237, pp. 879- 881 ,(1977) , 10.1001/JAMA.1977.03270360041015
Fred E. Karch, Adverse Drug Reactions JAMA. ,vol. 234, pp. 1236- 1241 ,(1975) , 10.1001/JAMA.1975.03260250028021