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Published in: Drug Safety 10/2002

01-08-2002 | Original Research Article

Detection of Adverse Drug Reactions in a Neurological Department

Comparison Between Intensified Surveillance and a Computer-Assisted Approach

Authors: Dr Petra A. Thuermann, Roland Windecker, Joachim Steffen, Markus Schaefer, Ute Tenter, Erich Reese, Hermann Menger, Klaus Schmitt

Published in: Drug Safety | Issue 10/2002

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Abstract

Objectives: Adverse drug reactions (ADRs) leading to hospitalisation or occurring during hospital stay contribute significantly to patient morbidity and mortality as well as representing an additional cost for healthcare systems. The aim of this study was to provide data about the type and incidence of ADRs in a neurological department and to compare two different methodological approaches to collecting information on ADRs.
Methods: The two methods used were intensified surveillance of neurological wards by daily ward rounds and computer-assisted screening for ADRs by means of pathological laboratory parameters.
Results: Of admissions to the neurological department, 2.7% were caused by an ADR and 18.7% of patients experienced at least one ADR during hospitalisation. The positive predictive values of pathological laboratory parameters ranged between 0% (eosinophil count) and 100% for increased drug serum concentrations and international normalised ratio, i.e. the latter were always accompanied by a clinically relevant ADR. However, only half of all ADR could be detected by pathological laboratory parameters, the sensitivity of this method came to 45.1% with a specificity of 78.9%.
Conclusion: Similar to departments of internal medicine, a high number of ADRs occur on neurological wards. The predominant ADRs were those typical of neurotropic medications such as dyskinesia and increased sedation. Due to the age of the patients involved, cardiovascular co-medication is often prescribed and represents an additional risk factor for ADRs. By measuring pathological laboratory parameters the majority of ADRs could not be detected in neurological patients.
Literature
1.
go back to reference Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. JAMA 1998; 279(15): 1200–17PubMedCrossRef Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. JAMA 1998; 279(15): 1200–17PubMedCrossRef
2.
go back to reference Mannesse CK, Derkx FHM, de Ridder MAJ, et al. Contribution of adverse drug reactions to hospital admission of older patients. Age Ageing 2000; 29(1): 35–9PubMedCrossRef Mannesse CK, Derkx FHM, de Ridder MAJ, et al. Contribution of adverse drug reactions to hospital admission of older patients. Age Ageing 2000; 29(1): 35–9PubMedCrossRef
3.
go back to reference Hallas J, Gram LF, Grodum E, et al. Drug related admissions to medical wards: a population based survey. Br J Clin Pharmacol 1992; 33(1): 61–8PubMedCrossRef Hallas J, Gram LF, Grodum E, et al. Drug related admissions to medical wards: a population based survey. Br J Clin Pharmacol 1992; 33(1): 61–8PubMedCrossRef
4.
go back to reference Roughead EE, Gilbert AL, Primrose JG, et al. Drug-related hospital admissions: a review of Australian studies published 1988-1996. Med J Aust 1998; 168(8): 405–8PubMed Roughead EE, Gilbert AL, Primrose JG, et al. Drug-related hospital admissions: a review of Australian studies published 1988-1996. Med J Aust 1998; 168(8): 405–8PubMed
5.
go back to reference Muehlberger N, Schneeweiss S, Hasford J. Adverse drug reaction monitoring: cost and benefit considerations part I: frequency of adverse drug reactions causing hospital admission. Pharmacoepidemiol Drug Saf 1997; 6Suppl. 3: 71S–77SCrossRef Muehlberger N, Schneeweiss S, Hasford J. Adverse drug reaction monitoring: cost and benefit considerations part I: frequency of adverse drug reactions causing hospital admission. Pharmacoepidemiol Drug Saf 1997; 6Suppl. 3: 71S–77SCrossRef
6.
go back to reference Pouyanne P, Haramburu F, Imbs JL, et al. Admissions to hospital caused by adverse drug reactions: cross sectional incidence study. BMJ 2000; 320: 1036PubMedCrossRef Pouyanne P, Haramburu F, Imbs JL, et al. Admissions to hospital caused by adverse drug reactions: cross sectional incidence study. BMJ 2000; 320: 1036PubMedCrossRef
7.
go back to reference Classen DC, Pestotnik SL, Evans RS, et al. Adverse drug events in hospitalized patients: excess length of stay, extra cost, and attributable mortality. JAMA 1997; 277(4): 301–6PubMedCrossRef Classen DC, Pestotnik SL, Evans RS, et al. Adverse drug events in hospitalized patients: excess length of stay, extra cost, and attributable mortality. JAMA 1997; 277(4): 301–6PubMedCrossRef
8.
go back to reference 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 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
9.
go back to reference Bates DW, Spell N, Cullen DC, et al. The costs of adverse drug events in hospitalized patients. JAMA 1997; 277(4): 307–11PubMedCrossRef Bates DW, Spell N, Cullen DC, et al. The costs of adverse drug events in hospitalized patients. JAMA 1997; 277(4): 307–11PubMedCrossRef
10.
go back to reference 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(3): 301–8PubMedCrossRef 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(3): 301–8PubMedCrossRef
11.
go back to reference Azaz-Livshits T, Levy M, Sadan B, et al. Computerized surveillance of adverse drug reactions in hospital: pilot study. Br J Clin Pharmacol 1998; 45(3): 309–14PubMedCrossRef Azaz-Livshits T, Levy M, Sadan B, et al. Computerized surveillance of adverse drug reactions in hospital: pilot study. Br J Clin Pharmacol 1998; 45(3): 309–14PubMedCrossRef
12.
go back to reference Fattinger K, Roos M, Vergères P, et al. Epidemiology of drug exposure and adverse drug reactions in two Swiss departments of internal medicine. Br J Clin Pharmacol 2000; 49(2): 158–67PubMedCrossRef Fattinger K, Roos M, Vergères P, et al. Epidemiology of drug exposure and adverse drug reactions in two Swiss departments of internal medicine. Br J Clin Pharmacol 2000; 49(2): 158–67PubMedCrossRef
13.
go back to reference Imbs JL, Pouyanne P, Haramburu F, et al. Iatrogénie médicamenteuse: estimation de sa prévalence dans les hôpitaux publics français. Therapie 1999; 54(1): 21–7PubMed Imbs JL, Pouyanne P, Haramburu F, et al. Iatrogénie médicamenteuse: estimation de sa prévalence dans les hôpitaux publics français. Therapie 1999; 54(1): 21–7PubMed
14.
go back to reference Bennett CL, Connors JM, Carwil JM, et al. Thrombotic thrombocytopenic purpura associated with clopidogrel. N Engl J Med 2000; 342(24): 1773–7PubMedCrossRef Bennett CL, Connors JM, Carwil JM, et al. Thrombotic thrombocytopenic purpura associated with clopidogrel. N Engl J Med 2000; 342(24): 1773–7PubMedCrossRef
15.
go back to reference Wood AJ. Thrombotic thrombocytopenic purpura and clopidogrel: a need for new approaches to drug safety. N Engl J Med 2000; 342(24): 1824–6PubMedCrossRef Wood AJ. Thrombotic thrombocytopenic purpura and clopidogrel: a need for new approaches to drug safety. N Engl J Med 2000; 342(24): 1824–6PubMedCrossRef
16.
go back to reference Landis NT. ADE rate uncertain, reporting systems inadequate, GAO tells legislators. Am J Health Syst Pharm 2000; 57(6): 515–9PubMed Landis NT. ADE rate uncertain, reporting systems inadequate, GAO tells legislators. Am J Health Syst Pharm 2000; 57(6): 515–9PubMed
17.
go back to reference Currie CJ, MacDonald TM. Use of routine healthcare data in safe and cost-effective drug use. Drug Saf 2000; 22(2): 97–102PubMedCrossRef Currie CJ, MacDonald TM. Use of routine healthcare data in safe and cost-effective drug use. Drug Saf 2000; 22(2): 97–102PubMedCrossRef
18.
go back to reference van den Bemt PMLA, Egberts ACG, Lenderink AW, et al. Adverse drug events in hospitalised patients: a comparison of doctors, nurses and patients as sources of reports. Eur J Clin Pharmacol 1999; 55(2): 155–8PubMedCrossRef van den Bemt PMLA, Egberts ACG, Lenderink AW, et al. Adverse drug events in hospitalised patients: a comparison of doctors, nurses and patients as sources of reports. Eur J Clin Pharmacol 1999; 55(2): 155–8PubMedCrossRef
19.
go back to reference Gardner RM, Pryor TA, Warner HR. The HELP hospital information system: update 1998. Int J Med Inf 1999; 54(3): 169–82CrossRef Gardner RM, Pryor TA, Warner HR. The HELP hospital information system: update 1998. Int J Med Inf 1999; 54(3): 169–82CrossRef
20.
go back to reference Classen DC, Pestotnik SL, Evans RS, et al. Computerized surveillance of adverse drug events in hospital patients. JAMA 1991; 266(20): 2847–51PubMedCrossRef Classen DC, Pestotnik SL, Evans RS, et al. Computerized surveillance of adverse drug events in hospital patients. JAMA 1991; 266(20): 2847–51PubMedCrossRef
21.
22.
go back to reference Impicciatore P, Choonara I, Clarkson A, et al. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001; 52(1): 77–83PubMedCrossRef Impicciatore P, Choonara I, Clarkson A, et al. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001; 52(1): 77–83PubMedCrossRef
23.
go back to reference World Health Organisation. International drug monitoring: the role of national centres.WHO Tech Rep Series 1972, No 498 World Health Organisation. International drug monitoring: the role of national centres.WHO Tech Rep Series 1972, No 498
24.
go back to reference Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, andmanagement. Lancet 2000; 356(9237): 1255–9PubMedCrossRef Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, andmanagement. Lancet 2000; 356(9237): 1255–9PubMedCrossRef
25.
26.
go back to reference Herings RMC, de Boer A, Stricker BHC, et al. Hypoglycaemia associated with the use of inhibitors of angiotensin converting enzyme. Lancet 1995; 345(8959): 1195–8PubMedCrossRef Herings RMC, de Boer A, Stricker BHC, et al. Hypoglycaemia associated with the use of inhibitors of angiotensin converting enzyme. Lancet 1995; 345(8959): 1195–8PubMedCrossRef
27.
go back to reference Schneeweiss S, Göttler M, Hasford J, et al. First results from an intensified monitoring system to estimate drug-related hospital admissions. Br J Clin Pharmacol 2001; 52(2): 196–200PubMedCrossRef Schneeweiss S, Göttler M, Hasford J, et al. First results from an intensified monitoring system to estimate drug-related hospital admissions. Br J Clin Pharmacol 2001; 52(2): 196–200PubMedCrossRef
28.
go back to reference Klotz U. Effect of age on pharmacokinetics and pharmacodynamics in man. Clin Pharmacol Ther 1998; 36(11): 581–5 Klotz U. Effect of age on pharmacokinetics and pharmacodynamics in man. Clin Pharmacol Ther 1998; 36(11): 581–5
29.
go back to reference Thürmann PA, Hompesch BC. Influence of gender on pharmacokinetics and pharmacodynamics of drugs. Int J Clin Pharmacol Ther 1998; 36(11): 586–90PubMed Thürmann PA, Hompesch BC. Influence of gender on pharmacokinetics and pharmacodynamics of drugs. Int J Clin Pharmacol Ther 1998; 36(11): 586–90PubMed
30.
go back to reference Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events. JAMA 1995; 274(1): 29–34PubMedCrossRef Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events. JAMA 1995; 274(1): 29–34PubMedCrossRef
31.
go back to reference Leape LL, Cullen DJ, Clapp MD, et al. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA 1999; 282(3): 267–70PubMedCrossRef Leape LL, Cullen DJ, Clapp MD, et al. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA 1999; 282(3): 267–70PubMedCrossRef
32.
go back to reference Grohmann R, Hippius H, Müller-Oehrlinghausen B, et al. Assessment of adverse drug reactions in psychiatric hospitals. Eur J Clin Pharmacol 1984; 26(6): 727–34PubMedCrossRef Grohmann R, Hippius H, Müller-Oehrlinghausen B, et al. Assessment of adverse drug reactions in psychiatric hospitals. Eur J Clin Pharmacol 1984; 26(6): 727–34PubMedCrossRef
33.
go back to reference Benichou C. Criteria of drug-induced liver disorders: report of an international consensus meeting. J Hepatol 1990; 11(2): 272–6PubMedCrossRef Benichou C. Criteria of drug-induced liver disorders: report of an international consensus meeting. J Hepatol 1990; 11(2): 272–6PubMedCrossRef
34.
go back to reference Hall M, McCormack P, Arthurs N, et al. The spontaneous reporting of adverse drug reactions by nurses. Br J Clin Pharmacol 1995; 40(2): 173–5PubMedCrossRef Hall M, McCormack P, Arthurs N, et al. The spontaneous reporting of adverse drug reactions by nurses. Br J Clin Pharmacol 1995; 40(2): 173–5PubMedCrossRef
Metadata
Title
Detection of Adverse Drug Reactions in a Neurological Department
Comparison Between Intensified Surveillance and a Computer-Assisted Approach
Authors
Dr Petra A. Thuermann
Roland Windecker
Joachim Steffen
Markus Schaefer
Ute Tenter
Erich Reese
Hermann Menger
Klaus Schmitt
Publication date
01-08-2002
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 10/2002
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.2165/00002018-200225100-00004

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