Advances in the Diagnosis of Adverse Drug Reactions

The clinician plays a key role in the detection and diagnosis of adverse drug reactions (ADRs). The diagnosis of ADRs, however, is a complex task. In the past, there were no systematically applied diagnostic criteria for ADRs, no formal methods of case analysis, no standardized epidemiologic approaches, and a limited knowledge of mechanisms. This resulted in the overdiagnosis of ADRs, which has negative consequences such as limiting treatment options. Recently, there have been various improvements in the diagnosis of ADRs, such as the development of standardized decision aids and of in vitro diagnostic tests. This article briefly reviews some of this knowledge, discusses the role of in vivo and in vitro rechallenge, and summarizes a probabilistic approach for collecting relevant information and diagnosing ADRs. The intention is to increase awareness of the different approaches for diagnosing ADRs as well as to stimulate researchers to continue to collect pharmacoepidemiologic information, study the pharmacologic, immunologic, and genetic factors involved in the pathogenesis of drug reactions, and develop and test new diagnostic instruments under various clinical conditions.

[1]  David J. Spiegelhalter,et al.  Computerized Aids for Probabilistic Assessment of Drug Safety I: A Spreadsheet Program* , 1991 .

[2]  C. Naranjo A Bayesian Approach to Assessment of Adverse Drug Reactions: Evaluation of a Case of Cholestatic Jaundice , 1986 .

[3]  R. Weinshilboum,et al.  Thiopurine pharmacogenetics in leukemia: Correlation of erythrocyte thiopurine methyltransferase activity and 6‐thioguanine nucleotide concentrations , 1987, Clinical pharmacology and therapeutics.

[4]  F T de Dombal Computer-aided decision support in clinical medicine. , 1989, International journal of bio-medical computing.

[5]  K. Alanko,et al.  Oral provocation: uses. , 1989, Seminars in dermatology.

[6]  Microcomputer-Assisted Bayesian Differential Diagnosis of Severe Adverse Reactions to New Drugs: A 4-Year Experience , 1991 .

[7]  D. G. Swain Computer aided diagnosis of acute abdominal pain , 1986 .

[8]  C. Naranjo A Clinical Pharmacologic Perspective on the Detection and Assessment of Adverse Drug Reactions , 1986, Drug information journal.

[9]  P M Gertman,et al.  Iatrogenic illness on a general medical service at a university hospital* , 1981, Quality and Safety in Health Care.

[10]  E. Freis,et al.  A study of diagnostic errors. , 1957, Annals of internal medicine.

[11]  M. Pflanz,et al.  Appendectomy in the Federal Republic of Germany: Epidemiology and Medical Care Patterns , 1971, Medical care.

[12]  Taylor Tr Computers in medicine in the decade of the 1970's. , 1970 .

[13]  J. Idle,et al.  POLYMORPHIC HYDROXYLATION OF DEBRISOQUINE IN MAN , 1977, The Lancet.

[14]  R G Edwards,et al.  Evaluation of benefits of screening tests done immediately on admission to hospital. , 1976, Clinical chemistry.

[15]  M. Eastwood,et al.  NEUTROPHIL FUNCTION AND MYELOPEROXIDASE ACTIVITY IN INFLAMMATORY BOWEL DISEASE , 1976, The Lancet.

[16]  A. S. Gross,et al.  The genetic polymorphism of debrisoquine/sparteine metabolism--clinical aspects. , 1990, Pharmacology & therapeutics.

[17]  C. Naranjo,et al.  A Bayesian Assessment of Idiosyncratic Adverse Reactions to New Drugs: Guillain‐Barré Syndrome and Zimeldine , 1990, Journal of clinical pharmacology.

[18]  G. Alván,et al.  Clinical consequences of polymorphic drug oxidation , 1991, Fundamental & clinical pharmacology.

[19]  D. Greenblatt,et al.  A method for estimating the probability of adverse drug reactions , 1981, Clinical pharmacology and therapeutics.

[20]  G. Venning Identification of adverse reactions to new drugs. I: What have been the important adverse reactions since thalidomide? , 1983, British medical journal.

[21]  A Bayesian Approach to Assessment of Adverse Drug Reactions: Evaluation of a Case of Acute Renal Failure , 1986 .

[22]  N. Shear Diagnosing cutaneous adverse reactions to drugs. , 1990, Archives of dermatology.

[23]  D. Bruynzeel,et al.  Patch testing in drug eruptions. , 1989, Seminars in dermatology.

[24]  James A. Reggia,et al.  An Overview of Methods for Computer-Assisted Medical Decision Making , 1985 .

[25]  M. Rieder,et al.  Diagnosis of sulfonamide hypersensitivity reactions by in-vitro "rechallenge" with hydroxylamine metabolites. , 1989, Annals of internal medicine.

[26]  L. Koran,et al.  The reliability of clinical methods, data and judgments (second of two parts). , 1975, The New England journal of medicine.

[27]  M. Stephens The diagnosis of adverse medical events associated with drug treatment. , 1987, Adverse drug reactions and acute poisoning reviews.

[28]  M. Lennard The polymorphic oxidation of beta-adrenoceptor antagonists. , 1989, Pharmacology & therapeutics.

[29]  T. R. Taylor,et al.  Computers in medicine in the decade of the 1970's. , 1970, Scottish medical journal.

[30]  C. Naranjo,et al.  Recent Developments in Computer-Assisted Diagnosis of Putative Adverse Drug Reactions , 1991, Drug safety.

[31]  S. Halevy,et al.  Macrophage migration inhibition factor (MIF) in drug eruption. , 1990, Archives of dermatology.

[32]  M. Girard Oral provocation: limitations. , 1989, Seminars in dermatology.

[33]  S. Spielberg,et al.  Anticonvulsant hypersensitivity syndrome. In vitro assessment of risk. , 1988, The Journal of clinical investigation.

[34]  G. Sutton Computer aided diagnosis of acute abdominal pain , 1986, British medical journal.

[35]  Judith K. Jones Evaluation of a Case of Stevens-Johnson Syndrome , 1986 .

[36]  C. Naranjo,et al.  The Bayesian Differential Diagnosis of Neutropenia Associated with Antiarrhythmic Agents , 1990, Journal of clinical pharmacology.

[37]  L Lasagna,et al.  Adverse drug reactions—a matter of opinion , 1976, Clinical pharmacology and therapeutics.

[38]  D. Grant,et al.  Differences in metabolism of sulfonamides predisposing to idiosyncratic toxicity. , 1986, Annals of internal medicine.

[39]  van Ketel Wg,et al.  Patch testing in drug eruptions. , 1989 .

[40]  S. Spielberg,et al.  In-vitro assessment of a hypersensitivity syndrome associated with sorbinil. , 1991, Annals of internal medicine.

[41]  C. Naranjo,et al.  The causality assessment of adverse drug reactions using a bayesian approach , 1987 .

[42]  A. Coulson,et al.  Response of human blood lymphocytes to tuberculin PPD in tissue culture. , 1967, Immunology.

[43]  G. Danan,et al.  Experts' Opinion in Causality Assessment: Results of Consensus Meetings , 1991 .

[44]  A. Dawid,et al.  Computerized Aids for Probabilistic Assessment of Drug Safety II: An Expert System* , 1991 .

[45]  L Lasagna,et al.  Adverse drug reactions. A critical review. , 1975, JAMA.

[46]  F. Sjöqvist,et al.  Plasma levels of monomethylated tricyclic antidepressants during treatment with imipramine-like compounds. , 1967, Life sciences.

[47]  F T de Dombal,et al.  Pattern-recognition: a comparison of the performance of clinicians and non-clinicians--with a note on the performance of a computer-based system. , 1972, Methods of information in medicine.