Abstract
BackgroundAdverse reactions and medication errors are complications of drug use. Spontaneous reporting systems and pharmacoepidemiological studies incompletely detect the occurrence of these events in daily hospital care. In this study, the frequency and type of drug-related admissions and hospital-acquired adverse drug events (ADE) in Germany were assessed using routinely collected hospital data.MethodsThe study was based on aggregated hospital routine data covering the period 2003 to 2007 and annually recorded as part of the further development of the German Diagnosis-Related Groups. The 505 ICD-10-codes indicating an ADE were categorized in seven groups according to their certainty. Primary diagnoses were considered as a proxy for drug-related admissions, and secondary diagnoses as a proxy for hospital-acquired ADE.ResultsAmong all hospital admissions, 5% were found to be at least possibly drug-induced and 0.7% very likely drug-induced. There was a significant increase in the overall rate of drug-related admissions over time (p < 0.038). Enterocolitis due to Clostridium difficile infection was the most frequent cause of a drug-related admission. About 4.5% of in-patients had experienced a hospital-acquired ADE. In addition, over the course of the study period, the overall frequency of hospital-acquired ADEs significantly increased (p < 0.001).ConclusionsIn Germany, more than 5% of hospital episodes are either caused or complicated by an ADE. Between 2003 and 2007, there was a statistically significant increase in the overall rate and in some of the subcategories defined by the list of ICD-10-codes suspected to be indicative of an ADE. Before the use of routine data in pharmacovigilance and patient safety can be fully exploited, a further tailoring of both the ICD and the available variable set is needed.
Highlights
Adverse reactions and medication errors are complications of drug use
Since a clear differentiation between adverse drug reactions (ADR) and medication errors was not possible based on the available routine data; both events were subsumed within the definition of an adverse drug events (ADE)
The hospital routine data comprise, among other items, diagnoses coded by the International Statistical Classification of Diseases and Related Health Problems, 10th Revision, German Modification (ICD-10-GM) and procedures coded according to a national classification of operations and procedures (OPS)
Summary
Adverse reactions and medication errors are complications of drug use. Spontaneous reporting systems and pharmacoepidemiological studies incompletely detect the occurrence of these events in daily hospital care. The frequency and type of drug-related admissions and hospital-acquired adverse drug events (ADE) in Germany were assessed using routinely collected hospital data. Adverse drug events (ADE) occur as a consequence of medication errors or as adverse drug reactions (ADR). Studies and systematic reviews have revealed that 5-10% of all internal-medicine admissions result from ADRs. 5-10% of all in-patients are expected to suffer from severe ADRs, and ADRs rate among the leading causes of death in the Western world [1,2,3,4,5,6]. A report by the US American Institute of Medicine, “To Err Is Human: Building a Safer Health System,” together with other, similar international reports, has had a lasting effect on public awareness with regard to safe pharmacotherapy and the prevention of medication errors [8]. As a result of these publications, critical-incident reporting systems and computerized physician-order entry systems combining patient- and medication-related information were recommended and subsequently introduced as a key approach to the reduction of medication errors [9,10,11]
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