Epidemiology of drug exposure and adverse drug reactions in two swiss departments of internal medicine.
OBJECTIVE
To explore drug exposure, frequency of adverse drug reactions (ADRs), types of ADRs, predisposing risk factors and ADR-related excess hospital stay in medical inpatients.


METHODS
Structured data regarding patient characteristics, 'events' (symptoms, laboratory results), diagnoses (ICD10) and drug therapy were collected using a computer-supported data entry system and an interface for data retrieval from electronic patient records. ADR data were collected by 'event monitoring' to minimize possible bias by the drug monitor. The causality of each event was assessed in relation to disease(s) and drug therapy.


RESULTS
The analysis included 4331 (100%) hospitalizations. The median observation period was 8 days. The median number of different drugs administered per patient and day was 6 and varied between 4 (Q1 ) and 9 (Q3 ) different drugs in 50% of all hospital days. In 41% of all hospitalizations at least one disease-unrelated event could be possibly attributed to drug therapy. Clinically relevant ADRs occurred in 11% of all hospitalizations. In 3.3% of all hospitalizations ADRs were the cause of hospital admission. The incidence of possibly ADR-related deaths was 1.4. Factors predisposing for clinically relevant ADRs were female gender and polypharmacy. ADR-related excess hospital stay accounted for 8. 6% of hospital days.


CONCLUSIONS
These data demonstrate the feasibility of the developed 'event monitoring' system for quantitative analysis of ADRs in medical inpatients. With increasing numbers of recorded patients the pharmacoepidemiological database provides a valuable tool to study specific questions regarding drug efficacy and safety in hospitalized patients.
Fattinger
K
K
Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital, Zurich, Switzerland. fattinge@kpt.unizh.ch
Roos
M
M
Vergères
P
P
Holenstein
C
C
Kind
B
B
Masche
U
U
Stocker
D N
DN
Braunschweig
S
S
Kullak-Ublick
G A
GA
Galeazzi
R L
RL
Follath
F
F
Gasser
T
T
Meier
P J
PJ
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000367:Age Factors; D000380:Agranulocytosis / Q000139:chemically induced / Q000401:mortality; D000799:Angioedema / Q000139:chemically induced / Q000401:mortality; D015331:Cohort Studies; D004194:Disease / Q000209:etiology; D004358:Drug Therapy / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D006402:Hematologic Diseases / Q000139:chemically induced / Q000453:epidemiology; D006760:Hospitalization; D006784:Hospitals, Teaching / Q000706:statistics & numerical data*; D006801:Humans; D007388:Internal Medicine; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D019338:Polypharmacy; D012307:Risk Factors; D012737:Sex Factors; D013557:Switzerland / Q000453:epidemiology