Zusammenfassung
Mit unerwünschte Arzneimittelwirkungen (UAW) ist bei etwa 5% aller medikamentösen Behandlungen zu rechnen. Mehrere Tausend Patienten versterben jährlich in Deutschland an UAW. Die auslösenden Arzneimittel sind überwiegend nichtsteroidale Antirheumatika, Antikoagulanzien und Acetylsalicylsäure, gefolgt von Herz-Kreislauf-Medikamenten. Das UAW-Spektrum beinhaltet daher zum großen Teil Blutungen (im Gastrointestinaltrakt) und kardiovaskuläre Störungen. Andererseits gibt es jedes Jahr mehr oder weniger spektakuläre Marktrücknahmen von Arzneimitteln wegen UAW, in jüngster Zeit Coxibe, davor Cisaprid und Cerivastatin. Diese Marktrücknahmen beruhen meist auf eher seltenen UAW, deren Diagnostik nicht immer einfach ist. Ärzte sind laut Musterberufsordnung verpflichtet, UAW zu melden. Häufig wird dies unterlassen, weil die UAW entweder zu bekannt oder die Diagnose nicht gesichert ist. Bei einigen UAW ist der histopathologische Befund ausschlaggebend dafür, ob es sich um eine UAW oder eine Erkrankung handelt. Daher sollte bei der Übersendung des Materials an die Pathologie die Medikation im Verdachtsfall genannt werden, damit diese Information in die Beurteilung des Präparates einfließen kann.
Abstract
Adverse drug reactions (ADR) occur in about 5% of all pharmacologically treated patients. Between 2% and 20% of all hospital admissions are caused by ADR, and approximately 10% of all hospitalized patients experience ADR during their hospital stay. Several thousand patients die due to ADR in Germany each year. ADR-associated drugs come predominantly from the class of non-steroidal antiinflammatory drugs, anticoagulants, acetysalicylic acid and cardiovascular drugs. Most ADR cases present as gastrointestinal bleeding and adverse cardiovascular effects. Apart from this, one or more drugs are withdrawn from the market each year because of unwanted but mostly rare side effects. In recent years the most prominent cases were rofecoxib, cisapride and cerivastatin. Physicians in Germany are obliged to report ADR. A substantial proportion of ADR, however, is not reported because it is deemed to be either too well known or the association between the drug and the adverse effect is too doubtful. In some cases, histopathological findings are needed to determine the diagnosis of ADR. Accordingly, physicians should inform the pathologist whether an ADR is suspected and which drugs may be responsible.
Literatur
Aithal GP, Rawlins MD, Day CP (1999) Accuracy of hepatic adverse drug reaction reporting in one English health region. BMJ 319:1541
Andersohn F, Bronder E, Klimpel A, Garbe E (2004) Proportion of drug-related serious rare blood dyscrasias: estimates from the Berlin Case-Control Surveillance Study. Am J Hematol 77:316–318
Bates DW, Spell N, Cullen DC et al. (1997) The costs of adverse drug events in hospitalized patients. JAMA 277:307–311
Berthold H, Schott G, Müller-Oerlinghausen B, Arzneimittelkommission der Deutschen Ärzteschaft (2005) Pharmakovigilanz. AVP Sonderheft, 1. Aufl.
Bjorkman D (1998) Nonsteroidal anti-inflammatory drug-associated toxicity of the liver, lower gastrointestinal tract and esophagus. Am J Med 105:17S–21S
Classen DC, Pestotnik SL, Evans RS et al. (1991) Computerized surveillance of adverse drug events in hospital patients. JAMA 266:2847–2851
Classen DC, Pestotnik SL, Evans RS et al. (1997) Adverse drug events in hospitalized patients. JAMA 277:301–306
Collette D, Thürmann PA (2002) Unerwünschte Arzneimittelwirkungen. Erbliche Unterschiede im Arzneistoffmetabolismus. Dtsch Med Wochenschr 127:1025–1028
Council for International Organizations of Medical Sciences (1999) Reporting adverse drug reactions: definitions of terms and criteria for their use. ISBN 92 9036 071 2
Currie CJ, MacDonald TM (2000) Use of routine healthcare data in safe and cost-effective drug use. Drug Saf 22:97–102
Danan G, Benichou C (1993) Causality assessment of adverse reactions to drugs — A novel method based on the conclusions of international concensus meetings: application to drug-induced liver injuries. J Clin Epidemiol 46:1323–1330
Dormann H, Muth-Selbach U, Krebs S et al. (2000) Incidence and costs of adverse drug reactions during hospitalisation. Drug Saf 2:161–168
Edwards IR, Aronson JK (2000) Adverse drug reactions: definitions, diagnosis, and management. Lancet 356:1255–1259
Faich GA (1991) National adverse drug reaction reporting 1984–1989. Arch Intern Med 151:1645–1647
Garbe E, Suissa S, LeLorier J (1998) Association of inhaled corticosteroid use with cataract extraction in elderly patients. JAMA 280:539–543
Göttler M, Schneeweiss S, Hasford J (1997) Adverse drug reaction monitoring — Cost and benefit considerations part II: cost and preventability of adverse drug reactions leading to hospital admission. Pharmacoepidemiol Drug Saf 6 [3 Suppl]:79S–90S
Göttler M, Munter K-H, Hasford J, Mueller-Oerlinghausen (1999) Zu viele Ärzte sind „meldemüde“. Dtsch Ärztebl 96:A1704–A1706
Grohmann R, Engel RR, Rüther E, Hippius H (2004) The AMSP drug safety program: methods and global results. Pharmacopsychiatry 37:S4–S11
Haen E (2004) AGATE: Qualitätssicherung in der Psychopharmakotherapie. Neurotransmitter 15:34–43
Haffner S, von Laue N, Wirth S, Thürmann PA (2005) Detecting adverse drug reactions on paediatric wards. Intensified surveillance versus computerised screening of laboratory values. Drug Saf 28:453–464
Hoffmann TK, Schmiedeberg S v, Wulferink M et al. (2005) Dapson-induzierte Agranulozytose. Die Rolle fremdstoff-metabolisierender Enzyme am Beispiel einer Kasuistik. Der Hautarzt 56:673–678
Lazarou J, Pomeranz BH, Corey PN (1998) Incidence of adverse drug reactions in hospitalized patients. JAMA 279:1200–1217
Leape LL, Bates DW, Cullen DC et al. (1995) Systems analysis of adverse drug events. JAMA 274:35–43
Lee WM (1995) Drug-induced hepatotoxicity. New Engl J Med 333:1118–1127
Lee WM (2003) Medical progress: drug-induced hepatotoxicity. New Engl J Med 349:474–485
Lewis JA (1981) Post-marketing surveillance: how many patients? TiPS 2:93–94
Mockenhaupt M (2004) Zentrale Erfassung blasenbildender, oft Arzneimittel-induzierter schwerer Hautreaktionen. Arzneimitteltherapie 17:97–99
Queißer-Luft A, Stolz G, Wiesel A et al. (2002) Malformations in newborn: results based on 30940 infants and fetuses from the Mainz congenital birth defect monitoring system (1990–1998). Arch Gynecol Obstet 266:163–167
Ravnskov U (1999) Glomerular, tubular and interstitial nephritis associated with non-steroidal anti-inflammatory drugs. Evidence of a common mechanism. Br J Clin Pharmacol 47:203–210
Schaefer C, Spielmann H, Vetter K (2001) Arzneiverordnung in Schwangerschaft und Stillzeit, 6. Aulf. Urban & Fischer, München
Schneeweiss S, Hasford J, Göttler M et al. (2002) Admissions caused by adverse drug events to internal medicine and emergency departments in hospitals: a longitudinal population-based study. Eur J Clin Pharmacol 58:285–291
Thiessard F, Roux E, Miremont-Salame G et al. (2005) Trends in spontaneous adverse drug reaction reports to the French pharmacovigilance system (1986–2001). Drug Saf 28:731–740
Thürmann PA (2001) Detection of adverse drug reactions in hospitals. Drug Saf 24:961–968
Thürmann PA, Schmitt K (1998) Erfassung und Bewertung unerwünschter Arzneimittelwirkungen. Med Klin 93:687–692
Thürmann PA, Windecker R, Steffen J et al. (2002) Detection of adverse drug reactions in a neurological department: comparison between intensified surveillance and a computer-assisted approach. Drug Saf 25:713–724
Venning GR (1983) Identification of adverse drug reactions to new drugs. II – How were 18 important adverse drug reactions discovered and with what delays? Br Med J 286:289–292
Interessenkonflikt:
Es besteht kein Interessenkonflikt. Der korrespondierende Autor versichert, dass keine Verbindungen mit einer Firma, deren Produkt in dem Artikel genannt ist, oder einer Firma, die ein Konkurrenzprodukt vertreibt, bestehen. Die Präsentation des Themas ist unabhängig und die Darstellung der Inhalte produktneutral.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Thürmann, P.A. Unerwünschte Arzneimittelwirkungen. Pathologe 27, 6–12 (2006). https://doi.org/10.1007/s00292-005-0805-y
Issue Date:
DOI: https://doi.org/10.1007/s00292-005-0805-y