This study demonstrated that at a paediatric isolation ward the incidence of ADRs caused by unlicensed or off-label drug use was not significantly more than that caused by the licensed drug use. However, patients treated with unlicensed or off-label drugs were shown to possess a significantly increased risk for developing ADRs.

Abstract. Dormann H, Neubert A, Criegee-Rieck M, Egger T, Radespiel-Tröger M, Azaz-Livshits T, Levy M, Brune K, Hahn EG (University of ErlangenNuremberg, Germany; and Hadassah-Hebrew University Medical Center, Jerusalem, Israel) Readmissions and adverse drug reactions in internal medicine: the economic impact.

In geriatric patients the incidence of ADRs is high. Computerised drug databases are a useful tool for detecting and avoiding ADRs. Our software, however, also produced a large number of signals that did not relate to actual ADRs found by the PET. The sheer number of these 'false' signals shows the need for refinement and optimisation of databases for daily clinical use.

BackgroundThe European eHealthMonitor project (eHM) developed a user-sensitive and interactive web portal for dementia care: the eHM Dementia Portal (eHM-DP). It aims to provide targeted and personalized support for informal caregivers of people with dementia in a home-based care setting. The objective of the pilot study was to obtain feedback on the eHM-DP from two user perspectives (caregivers and medical professionals), focusing on caregiver empowerment, decision aid, and the perceived benefits of the eHM-DP.MethodsThe study on the eHM-DP was conducted from March 2014 to June 2014. The methodological approach followed a user-participatory design with a total number of 42 participants. The study included caregivers of people with dementia and medical professionals (MPs) from the metropolitan region of Erlangen-Nürnberg (Bavaria, Germany). Study participants were interviewed face-to-face with semi-structured, written interviews.ResultsCaregivers indicated a high degree of perceived support by the eHM-DP and of provided decision aid. In total, 89 % of caregivers and 54 % of MPs would use the eHM-DP if access were provided. The primary benefits participants perceived were the acquisition of individualized information, computerized interaction between caregivers and MPs, empowerment in health-related decisions and comprehensive insights into the progress of the disease. Major recommendations for improving the eHM-DP encompassed: an active search functionality based on predefined terms, the implementation of a chatroom for caregivers, an upload function and alerts for MPs, as well as the overall design.ConclusionsOur study is the first to have provided new insights and results on an interactive and needs-oriented web portal, endeavouring towards empowerment and assistance in decision making for caregivers as well as MPs within the realm of caring for patients with dementia. The acceptance and willingness to use the eHM-DP emphasizes the potential of eHealth services for community-based dementia care settings.Electronic supplementary materialThe online version of this article (doi:10.1186/s12911-015-0182-2) contains supplementary material, which is available to authorized users.

Computer monitoring is an effective method for improving the detection of adverse drug reactions in inpatients. The excess length of stay and costs caused by adverse drug reactions are substantial and might be considerably reduced by earlier detection.

Awareness of existing ADRs on hospital admission and appropriate prescribing prior to hospital admission require attention. Early detection of ADRs on hospital admission can be achieved by the use of computer support systems. Many ADRs could be prevented by adhering to indications and contraindications.

AIMSComputer-assisted signal generation is an important issue for the prevention of adverse drug reactions (ADRs). However, due to poor standardization of patients' medical data and a lack of computable medical drug knowledge the specificity of computerized decision support systems for early ADR detection is too low and thus those systems are not yet implemented in daily clinical practice. We report on a method to formalize knowledge about ADRs based on the Summary of Product Characteristics (SmPCs) and linking them with structured patient data to generate safety signals automatically and with high sensitivity and specificity. METHODSA computable ADR knowledge base (ADR-KB) that inherently contains standardized concepts for ADRs (WHO-ART), drugs (ATC) and laboratory test results (LOINC) was built. The system was evaluated in study populations of paediatric and internal medicine inpatients. RESULTSA total of 262 different ADR concepts related to laboratory findings were linked to 212 LOINC terms. The ADR knowledge base was retrospectively applied to a study population of 970 admissions (474 internal and 496 paediatric patients), who underwent intensive ADR surveillance. The specificity increased from 7% without ADR-KB up to 73% in internal patients and from 19.6% up to 91% in paediatric inpatients, respectively. CONCLUSIONSThis study shows that contextual linkage of patients' medication data with laboratory test results is a useful and reasonable instrument for computer-assisted ADR detection and a valuable step towards a systematic drug safety process. The system enables automated detection of ADRs during clinical practice with a quality close to intensive chart review.

SUMMARYAim: To investigate the effectiveness of a computer monitoring system that detects adverse drug reactions (ADRs) by laboratory signals in gastroenterology. Methods: A prospective, 6-month, pharmacoepidemiological survey was carried out on a gastroenterological ward at the University Hospital Erlangen-Nuremberg. Two methods were used to identify ADRs. (i) All charts were reviewed daily by physicians and clinical pharmacists. (ii) A computer monitoring system generated a daily list of automatic laboratory signals and alerts of ADRs, including patient data and dates of events. Results: One hundred and nine ADRs were detected in 474 admissions (377 patients). The computer monitoring system generated 4454 automatic laboratory signals from 39 819 laboratory parameters tested, and issued 2328 alerts, 914 (39%) of which were associated with ADRs; 574 (25%) were associated with ADRpositive admissions. Of all the alerts generated, signals of hepatotoxicity (1255), followed by coagulation disorders (407) and haematological toxicity (207), were prevalent. Correspondingly, the prevailing ADRs were concerned with the metabolic and hepato-gastrointestinal system (61). The sensitivity was 91%: 69 of 76 ADR-positive patients were indicated by an alert. The specificity of alerts was increased from 23% to 76% after implementation of an automatic laboratory signal trend monitoring algorithm. Conclusion: This study shows that a computer monitoring system is a useful tool for the systematic and automated detection of ADRs in gastroenterological patients.