Barbara Pfistermeister

Adverse drug events in older patients admitted as an emergency: the role of potentially inappropriate medication in elderly people (PRISCUS).

BACKGROUND Lists of potentially inappropriate medications (PIMs) for the elderly, such as the German PRISCUS list, have been published as expert recommendations with the aim of improving drug safety for this patient group. In this study, we tried to determine how often adverse drug events occur in the emergency department and what role PRISCUS medications might play in these events. METHODS We prospectively reviewed the medical records of 752 patients who were treated in the emergency department (ED) of a level III hospital in Germany for adverse drug events due to medication errors (MEs) and for adverse drug reactions (ADRs). The evaluation was performed in two steps by pharmacologists, clinical pharmacologists, and board-certified internists. RESULTS Both clinically important MEs and ADRs became more common with advancing age. Among the 351 patients who were over age 65, 307 (87.5%) were taking at least one medication at home. Of these 307 patients, 16.6% (95% confidence interval [CI]: 12.9-21.2%) were taking at least one PIM, as defined by the German PRISCUS list. In relative terms, PIMs were more commonly associated with ADRs or MEs than other drugs (27.0% [95% CI: 17.5-39.1% versus 15.7% [95% CI: 14.1-17.4%], Odds ratio 1.99 [95% CI: 1.23-3.52: p = 0.018), but in absolute terms ADRs and MEs involved non-PIM more often than PIM. CONCLUSION Elderly patients more frequently suffer from ADR and from the clinical consequences of medication errors. Elderly patients taking PIMs are more likely to suffer from ADRs and MEs, even though most drug-related events are still attributable to non-PIM.

Adverse drug events in patients admitted to an emergency department: an analysis of direct costs

Several economic evaluations of adverse drug events (ADEs) exist, but the underlying methodology has not been standardized so far. The aim of the study was to combine prospective, intensive pharmacovigilance methods, and standardized accounting data to calculate direct costs of community‐acquired ADEs (caADEs) contributing to emergency department (ED) admission and subsequent hospitalization.

Comparative evaluation of different medication safety measures for the emergency department: physicians’ usage and acceptance of training, poster, checklist and computerized decision support

BackgroundAlthough usage and acceptance are important factors for a successful implementation of clinical decision support systems for medication, most studies only concentrate on their design and outcome. Our objective was to comparatively investigate a set of traditional medication safety measures such as medication safety training for physicians, paper-based posters and checklists concerning potential medication problems versus the additional benefit of a computer-assisted medication check. We concentrated on usage, acceptance and suitability of such interventions in a busy emergency department (ED) of a 749 bed acute tertiary care hospital.MethodsA retrospective, qualitative evaluation study was conducted using a field observation and a questionnaire-based survey. Six physicians were observed while treating 20 patient cases; the questionnaire, based on the Technology Acceptance Model 2 (TAM2), has been answered by nine ED physicians.ResultsDuring field observations, we did not observe direct use of any of the implemented interventions for medication safety (paper-based and electronic). Questionnaire results indicated that the electronic medication safety check was the most frequently used intervention, followed by checklist and posters. However, despite their positive attitude, physicians most often stated that they use the interventions in only up to ten percent for subjectively “critical” orders. Main reasons behind the low usage were deficits in ease-of-use and fit to the workflow. The intention to use the interventions was rather high after overcoming these barriers.ConclusionsMethodologically, the study contributes to Technology Acceptance Model (TAM) research in an ED setting and confirms TAM2 as a helpful diagnostic tool in identifying barriers for a successful implementation of medication safety interventions. In our case, identified barriers explaining the low utilization of the implemented medication safety interventions - despite their positive reception - include deficits in accessibility, briefing for the physicians about the interventions, ease-of-use and compatibility to the working environment.

A new approach to identify, classify and count drug-related events

The incidence of clinical events related to medication errors and/or adverse drug reactions reported in the literature varies by a degree that cannot solely be explained by the clinical setting, the varying scrutiny of investigators or varying definitions of drug‐related events. Our hypothesis was that the individual complexity of many clinical cases may pose relevant limitations for current definitions and algorithms used to identify, classify and count adverse drug‐related events.

Medication safety and knowledge-based functions: a stepwise approach against information overload.

The aim was to improve medication safety in an emergency department (ED) by enhancing the integration and presentation of safety information for drug therapy.

Inconsistencies and Misleading Information in Officially Approved Prescribing Information From Three Major Drug Markets

The summary of product characteristics (SPC) should provide information for the safe prescription and use of a drug. We evaluated the consistency of critical interaction warnings, the quality of presentation of undesirable effects as well as concordance of critical information of representative drugs marketed in the United States, the UK, and Germany. Reciprocal warnings regarding drug–drug interactions that constitute contraindications were frequently missing in the SPCs of the drugs concerned (all countries >40%). Most SPCs did not explicitly exclude adverse reactions considered not reasonably attributable to the use of the drug. Comparing SPCs of different generic brands of the same drug, only 60, 10, and 20% of the US, UK, and German SPCs, respectively, provided identical contraindications. Current SPCs contain inconsistencies and misleading data that are not compatible with the purpose of SPCs, which is to provide a basis for the safe prescription and use of drugs.

Different indications, warnings and precautions, and contraindications for the same drug—an international comparison of prescribing information for commonly used psychiatric drugs

We aim to derive an internationally applicable data set to improve prescription safety of psychiatric drugs.

Anticholinergic burden and cognitive function in a large German cohort of hospitalized geriatric patients

Purpose Previous studies suggest an association between use of anticholinergic drugs in elderly patients and cognitive impairment. However, there are still limited data on the association of anticholinergic drug use and cognitive impairment as well as contribution of individual drugs to anticholinergic load using large, well-documented patient cohorts treated in geriatric units from Europe. Methods We investigated 797,440 prescriptions to 89,579 hospitalized patients treated in geriatric units within the GiB-DAT database. Data of all patients discharged between 1 January 2013 and 30 June 2015 was included. The Anticholinergic Cognitive Burden (ACB) scale was used to classify anticholinergic drugs as definite (score 2 or 3) and possible anticholinergics (score 1). Cognitive function was determined using Mini-Mental State Examination (MMSE) and the standardized scale for dementia (4D+S). Results In two multivariable logistic regression models age, sex, number of drugs and ACB total scores were identified as variables independently associated with cognitive impairment as measured by MMSE (odds ratio per ACB unit 1.114, 95% CI 1.099–1.130) or the diagnosis dementia (odds ratio 1.159 per ACB unit, 95% CI 1.144–1.173, both p < 0.0001). High anticholinergic load was associated with patients with severe cognitive impairment (p < 0.05 for all pairwise comparisons). ACB score 3 anticholinergic drugs contributed 77.9% to the cumulative amount of ACB points in patients with an anticholinergic load of 3 and higher. Conclusions Using a cross-sectional study design, a significant positive association between anticholinergic drug load and cognitive impairment in European patients treated in specialised geriatric units was found. The most frequently used definitve anticholinergic drugs were quetiapine, amitriptyline and carbamazepine.

Data Requirements for the Correct Identification of Medication Errors and Adverse Drug Events in Patients Presenting at an Emergency Department

BACKGROUND Adverse drug events (ADE) involving or not involving medication errors (ME) are common, but frequently remain undetected as such. Presently, the majority of available clinical decision support systems (CDSS) relies mostly on coded medication data for the generation of drug alerts. It was the aim of our study to identify the key types of data required for the adequate detection and classification of adverse drug events (ADE) and medication errors (ME) in patients presenting at an emergency department (ED). METHODS As part of a prospective study, ADE and ME were identified in 1510 patients presenting at the ED of an university teaching hospital by an interdisciplinary panel of specialists in emergency medicine, clinical pharmacology and pharmacy. For each ADE and ME the required different clinical data sources (i.e. information items such as acute clinical symptoms, underlying diseases, laboratory values or ECG) for the detection and correct classification were evaluated. RESULTS Of all 739 ADE identified 387 (52.4%), 298 (40.3%), 54 (7.3%), respectively, required one, two, or three, more information items to be detected and correctly classified. Only 68 (10.2%) of the ME were simple drug-drug interactions that could be identified based on medication data alone while 381 (57.5%), 181 (27.3%) and 33 (5.0%) of the ME required one, two or three additional information items, respectively, for detection and clinical classification. CONCLUSIONS Only 10% of all ME observed in emergency patients could be identified on the basis of medication data alone. Focusing electronic decisions support on more easily available drug data alone may lead to an under-detection of clinically relevant ADE and ME.