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Drug-related problems (DRPs), i.e., adverse drug reactions (ADRs) and medication errors (MEs), constitute a serious threat to the patient’s safety. DRPs are often insufficiently captured by clinical routine documentation, and thus, they frequently remain unaddressed. The aim of this study was to assess the coverage and usability of the new 11th revision of the WHO International Classification of Diseases (ICD-11) to document DRPs. We refined the ‘Quality and Safety Algorithm’ from the ICD-11 Reference Guide and used it for DRP reporting to code 100 different anonymized DRPs (50 ADRs and 50 MEs) in a German hospital. The ICD-11 three-part model consisting of harm, cause, and mode was used whenever they were applicable. Of 50 ADRs, 15 (30.0%), such as drug-induced osteoporosis, were fully classifiable and codable by the ICD-11, whereas 35 (70.0%), such as drug-induced hypokalaemia, could not be fully classified due to sanctioning rules preventing the postcoordination (i.e., a combination of specific codes, such as drug and diagnosis). However, coding without the loss of information was possible in the 35 of these 35 (100.0%) ADR cases when we were deviating from the cluster code order of the Reference Guide. In all 50 MEs, the mode could be encoded, but for none of the MEs, postcoordination, i.e., the assignment of the ME to a specific drug, was allowed. In conclusion, the ICD-11 three-part model enables us to acquire more detailed documentation of DRPs than the previous ICD versions did. However, the codability, documentation, and reporting of DRPs could be significantly improved by simple modifications of the current ICD-11 sanctioning rules and by the addition of new ICD-11 codes.

Unerwunschte Arzneimittelwirkungen (UAW) oder Medikationsfehler bei Notaufnahmepatienten werden haufig nicht oder zu spat als solche erkannt und tragen damit zu Todesfallen im akutstationaren Bereich bei. Welche Medikamente werden am haufigsten mit UAW assoziiert? Welche Leitsymptome bzw. Diagnosen konnen auf eine UAW hinweisen? Hierzu wird in diesem Beitrag gezielt eine Auswahl von kleinen Beobachtungsstudien bis hin zu multizentrischen Studien im akut- und notfallmedizinischen Setting zusammenfassend dargestellt. Welche UAW sollte man unbedingt kennen? Fur Notaufnahmen typische UAW, Arzneimittelinteraktionen, Applikationsfehler oder Verordnungskaskaden werden daruber hinaus an Beispielen erlautert. Zur Verbesserung der Arzneimitteltherapiesicherheit im Akut- und Notfallmanagement sind Fortbildungsangebote zu UAW, digitale Entscheidungsunterstutzungssysteme und der elektronische Zugriff auf Notfalldatensatze in Echtzeit essenziell. Die individuelle Arzneimitteltherapie unter Berucksichtigung pharmakogenetischer Unterschiede stellt eine weitere zukunftige Herausforderung dar.

Aims Older patients in particular suffer from adverse drug reactions (ADR) when presenting in the emergency department. We aimed to characterise the phenotype of those ADRs, to be able to recognise an ADR in older patients. Methods Cases of ADRs in emergency departments collected within the multicentre prospective observational study (ADRED) were analysed (n = 2215). We analysed ADR‐associated diagnoses, symptoms and their risk profiles. We present frequencies and odds ratios (OR) with 95% confidence intervals for adults (18–64 years) compared to older adults (≥65 years; young–old 65–79, old–old ≥80 years) and regression coefficients (B) for each year of age. Results Most prominent differences were seen for drug‐associated confusion, dehydration, and bradycardia (OR 6.70 [1.59–28.27], B .054; OR 6.02 [2.41–15.03], B .081, and 4.82 [2.21–10.54], B .040), more likely seen in older adults. Bleedings were reported in all age groups, but gastrointestinal bleedings occurred with more than doubled chance in older adults (OR 2.46 [1.77–3.41], B .030), likewise did other bleedings such as haemorrhage from respiratory passages (OR 2.89 [1.37–6.11], B.036). Falls were more likely in older adults (OR 2.84 [1.77–4.53], B .030), while dizziness was frequent in both age groups. Conclusion Our data point to differences in symptoms of ADRs between adults and older individuals, with dangerous drug‐associated phenomena in the older adult such as bleedings or falls. Physicians should consider drug‐associated origins of symptoms in older adults with an increased risk for serious health problems., publishedVersion

Introduction The prevalence of psychotropic drug use in our society is increasing especially in older adults, thereby provoking severe adverse drug reactions (ADR). To identify specific patient risk profiles associated with psychotropic drug use in the situation of polymedication. Methods Cases of ADRs in general emergency departments (ED) collected within the multi-center prospective observational study (ADRED) were analyzed (n=2215). We compared cases with use of psychotropic drugs and without concerning their clinical presentation at the ED. Results A third of patients (n=731, 33%) presenting to the ED with an ADR took at least 1 psychotropic drug. Patients with psychotropic drug use tended to be older, more often female, and took a higher number of drugs (all p Discussion The association of psychotropic drug use with fall and syncope in combination with polymedication and older age leads to the suspicion that psychotropic drugs might be potentially harmful in specific risk populations such as older adults. It may lead us to thoroughly weigh the benefit against risk in a patient-oriented way, leading to an integrative personalized therapy approach.

Drug-related problems (DRP, defined as adverse drug events/reactions and medication errors) are a common threat for patient safety. With the aim to aid improved allocation of specialist resources and to improve detection and prevention of DRP, numerous predictive scoring tools have been proposed. The external validation and evidence for the transferability of these tools still faces limitations. However, the proposed scoring tools include partly overlapping sets of similar factors, which may allow a new approach to estimate the external usability and validity of individual risk factors. Therefore, we conducted this systematic review and analysis. We identified 14 key studies that assessed 844 candidate risk factors for inclusion into predictive scoring tools. After consolidation to account for overlapping terminology and variable definitions, we assessed each risk factor in the number of studies it was assessed, and, if it was found to be a significant predictor of DRP, whether it was included in a final scoring tool. The latter included intake of ≥ 8 drugs, drugs of the Anatomical Therapeutic Chemical (ATC) class N, ≥1 comorbidity, an estimated glomerular filtration rate (eGFR)

Introduction In emergency care, geriatric requirements and risks are often not taken sufficiently into account. In addition, there are neither evidence-based recommendations nor scientifically developed quality indicators (QI) for geriatric emergency care in German emergency departments. As part of the GeriQ-ED© research project, quality indicators for geriatric emergency medicine in Germany have been developed using the QUALIFY-instruments. Methods Using a triangulation methodology, a) clinical experience-based quality aspects were identified and verified, b) research-based quality statements were formulated and assessed for relevance, and c) preliminary quality indicators were operationalized and evaluated in order to recommend a feasible set of final quality indicators. Results Initially, 41 quality statements were identified and assessed as relevant. Sixty-seven QI (33 process, 29 structure and 5 outcome indicators) were extrapolated and operationalised. In order to facilitate implementation into daily practice, the following five quality statements were defined as the GeriQ-ED© TOP 5: screening for delirium, taking a full medications history including an assessment of the indications, education of geriatric knowledge and skills to emergency staff, screening for patients with geriatric needs, and identification of patients with risk of falls/ recurrent falls. Discussion QIs are regarded as gold standard to measure, benchmark and improve emergency care. GeriQ-ED© QI focused on clinical experience- and research-based recommendations and describe for the first time a standard for geriatric emergency care in Germany. GeriQ-ED© TOP 5 should be implemented as a minimum standard in geriatric emergency care.

Individual differences in required drug dosages exist based on the pharmacogenomic (PGx) profiles. This study aimed to assess associations between PGx profiles and adverse drug reactions (ADR) that lead to admissions to the emergency department (ED). ADR cases of the prospective multi-center observational trial in EDs (ADRED study) were analyzed (n = 776) together with the relevant PGx phenotypes of the enzymes CYP2D6, CYP2C19, CYP2C9, and VKORC1. Overall, the allele frequency distribution in this cohort did not differ from the population frequencies. We compared the frequencies of phenotypes in the subgroups with the drugs suspected of certain ADR, in the remaining cases. The frequency distribution of CYP2C19 differed for the ADR bleeding cases suspected of clopidogrel (p = 0.020). In a logistic regression analysis, higher CYP2C19 activity (OR (95% CI): 4.97 (1.73−14.27)), together with age (1.05 (1.02−1.08)), showed an impact on the clopidogrel-suspecting ADRs, when adjusting for the clinical parameters. There was a trend for an association of phenprocoumon-risk profiles (low VKORC1 or CYP2C9 activity) with phenprocoumon-suspecting ADRs (p = 0.052). The PGx impact on serious ADRs might be highest in drugs that cannot be easily monitored or those that do not provoke mild ADR symptoms very quickly. Therefore, patients that require the intake of those drugs with PGx variability such as clopidogrel, might benefit from PGx testing., publishedVersion

ZusammenfassungDer individuelle Erfolg einer Arzneimitteltherapiesicherheit (AMTS) in der Notaufnahme (NA) beruht auf der differenzierten Abstimmung von Pharmaka auf die besondere Situation des Notfallpatienten. In der folgenden Übersichtsarbeit wird an Fallbeispielen herausgearbeitet, welche Risiken bei der Indikationsstellung, Applikation und Dosierung auftreten können. Die derzeitigen Systemprobleme für eine sichere Notaufnahme-AMTS sind: keine EDV-basierte AMTS, nicht in allen Notaufnahmen aktuelle EDV-Literaturdatenbanken und keine Einweisung analog MPG (Medizinproduktegesetz)/kein Training in Notfallpharmakologie.

Seit dem 01.10.2016 haben gesetzlich Versicherte unter bestimmten Voraussetzungen einen Anspruch auf einen bundeseinheitlichen Medikationsplan (BMP, gemas § 31a SGB V, E‑Health Gesetz). Der Masnahmenkatalog des 3. Aktionsplans 2013–2015 zur Verbesserung der Arzneimitteltherapiesicherheit (AMTS) sah die Erprobung des BMP in der Praxis hinsichtlich seiner Akzeptanz und Praktikabilitat in drei Modellprojekten vor. Diese drei Projekte – MetropolMediplan 2016, Erfurt und PRIMA – werden vorgestellt und auf der Basis der gesammelten Erkenntnisse Empfehlungen abgeleitet. Der BMP wurde von den Teilnehmern in allen Projekten begrust und fuhrte zu einem Anstieg der Patientenzufriedenheit und Verbesserung der Medikationskompetenz. Sowohl die Arzte- als auch die Apothekerschaft bewerteten die interdisziplinare und multiprofessionelle Zusammenarbeit uber das Medium BMP sehr positiv. Negativ empfunden wurden der hohe zeitliche Aufwand zur Ersterstellung und Fortschreibung sowie die fehlende Telematikinfrastruktur zur Umsetzung einer elektronischen Version BMP. Ein Originaldatenabgleich der BMP-Daten mit den tatsachlich eingenommenen Medikamenten zeigte, dass lediglich bei 36 % der Falle der BMP und die tatsachlich eingenommenen Arzneistoffe ubereinstimmten. Obwohl die Erstellung einer Papierversion des BMP nicht die Problematik der Aktualitat und Vollstandigkeit der Medikation zum Behandlungszeitpunkt losen konnte, wurde ein signifikanter Effekt auf die AMTS durch den BMP belegt. Neben Vorschlagen zur Verbesserung der Prozessintegration des BMP in die Versorgungsroutine der Arzte- und Apothekerschaft wird eine elektronisch sektorenubergreifende Verfugbarkeit des BMP gefordert. Der BMP sollte zukunftig ein zentrales und wichtiges Instrument zur Verbesserung der AMTS darstellen.

Tracheal rupture is a rare but serious complication after endotracheal intubation. We report the case of an 85-years-old female patient presenting a massive skin emphysema after endotracheal emergency intubation. A CT-scan of the thorax showed a massive mediastinal emphysema and a dislocated tube cuff in the pleural cavity. The implemented bronchoscopy also showed the suspicion for tracheal rupture. A double-lumen-tube-intubation failed due to a trapped tube cuff, which could not be extracted. In the following emergency surgery, the transthoracic intubation of the left main bronchus was the lifesaving procedure. Afterwards a successful tracheal reconstruction was made. When tracheal rupture occurs early detection and an accurate treatment is necessary.

Emergency departments need to continuously calculate quality indicators in order to perform structural improvements, improvements in the daily routine, and ad-hoc improvements in everyday life. However, many different actors across multiple disciplines collaborate to provide emergency care. Hence, patient-related data is stored in several information systems, which in turn makes the calculation of quality indicators more difficult. To address this issue, we aim to link and use routinely collected data of the different actors within the emergency care continuum. In order to assess the feasibility of linking and using routinely collected data for quality indicators and whether this approach adds value to the assessment of emergency care quality, we conducted a single case study in a German academic teaching hospital. We analyzed the available data of the existing information systems in the emergency continuum and linked and pre-processed the data. Based on this, we then calculated four quality indicators (Left Without Been Seen, Unplanned Reattendance, Diagnostic Efficiency, and Overload Closure). Lessons learned from the calculation and results of the discussions with staff members that had multiple years of work experience in the emergency department provide a better understanding of the quality of the emergency department, the related challenges during the calculation, and the added value of linking routinely collected data.

The symptoms of carbon monoxide (CO) poisoning are nonspecific, ranging from dizziness and headache to unconsciousness and death. A German national guideline on the diagnosis and treatment of this condition is lacking at present.This review is based on a selective literature search in the PubMed and Cochrane databases, as well as on existing guidelines from abroad and expert recommendations on diagnosis and treatment.The initiation of 100% oxygen breathing as early as possible is the most important treatment for carbon monoxide poisoning. In case of CO poisoning, the reduced oxygen-carrying capacity of the blood, impairment of the cellular respiratory chain, and immune-modulating processes can lead to tissue injury in the myocardium and brain even after lowering of the carboxyhemoglobin (COHb) concentration. In patients with severe carbon monoxide poisoning, an ECG should be obtained and biomarkers for cardiac ischemia should be measured. Hyperbaric oxygen therapy (HBOT) should be critically considered and initiated within six hours in patients with neurologic deficits, unconsciousness, cardiac ischemia, pregnancy, and/or a very high COHb concentration. At present, there is no general recommendation for HBOT, in view of the heterogeneous state of the evidence from multiple trials. Therapeutic decision-making is directed toward the avoidance of sequelae such as cognitive dysfunction and cardiac complications, and the reduction of mortality. Smoke intoxication must be considered in the differential diagnosis. The state of the evidence on the diagnosis and treatment of this condition is not entirely clear. Alternative or supplementary pharmacological treatments now exist only on an experimental basis.High-quality, prospective, randomized trials that would enable a definitive judgment of the efficacy of HBOT are currently lacking.

Adverse drug reactions (ADR) account for 5 to 7% of emergency department (ED) consultations. We aimed to assess medication risk profiles for ADRs leading to ED visits. We analysed medication intake and patient demographics in a prospective multi-centre observational study collecting ADR cases in four large EDs in Germany. Odds ratios (OR) were calculated to relate drug classes taken to those suspicious for an ADR after a causality assessment. A total of 2215 cases of ED visits due to ADRs were collected. The median age of the cohort was 73 years; in median, six co-morbidities and an intake of seven drugs were documented. Antineoplastic/immunomodulating agents had the highest OR for being suspected for an ADR (OR 20.45, 95% CI 14.54–28.77), followed by antithrombotics (OR 2.94, 95% CI 2.49–3.47), antibiotics (OR 2.65, 95% CI 1.78–3.95), systemic glucocorticoids (OR 2.43, 95% CI 1.54–3.82) and drugs affecting the central nervous system (CNS), such as antipsychotics (OR 2.36, 95% CI 1.46–3.81), antidepressants (OR 2.10, 95% CI 1.57–2.83), antiparkinsonian medication (OR 2.11, 95% CI 1.15–3.84), opioids (OR 1.79, 95% CI 1.26–2.54) and non-opioid analgesics (OR 1.32, 95% CI 1.01–1.72). Patients experiencing ADRs leading to ED visits are commonly old, multi-morbid and multi-medicated. CNS drugs may be more relevant than prior expected. With calculating ORs, we could replicate involvement of antineoplastic agents, antithrombotics, antibiotics, systemic glucocorticoids and non-opioid analgesics as frequently suspected for ADRs in EDs. DRKS-ID: DRKS00008979.

The use of cyclooxygenase (COX) inhibitors is increasingly common. Most of them are available for self-medication, either as analgesic or for cardio- and cerebrovascular prevention. We aimed to analyze adverse drug events (ADE) related to COX inhibitors and the concomitant use of proton pump inhibitors (PPI) according to guidelines in patients presenting at an emergency department (ED). In a prospective study, 2262 patients presenting consecutively at the ED of a tertiary care university teaching hospital were evaluated by intensive chart review in order to detect and classify all ADE. In this cross-sectional analysis all patients taking COX inhibitors at home were evaluated further. Of all evaluated patients, 753 (33.3 %) took COX inhibitors at home, 258 (34.3 %) with concomitant PPI. A total of 168 (22.3 %) patients suffered from at least one ADE related to COX inhibitors. The most common ADE observed were anemia (55.9 %) and gastrointestinal ADE (31.6 %, e. g., bleeding, gastritis, and ulcer). In 10.1 % of patients, a medication error (e. g., intake without proper clinical indication) contributed to the ADE and in 40.8 % of the ADE involved further contributing drugs. Only 38.8–42.1 % of patients with a high gastrointestinal risk were prescribed a PPI concomitantly. ADE related to COX inhibitors were found in every fifth patient taking COX inhibitors. One-tenth of all ADE involving COX inhibitors were related to medication errors. The guideline-based concomitant use of PPI was only in part implemented.

Since 1 October 2016, all legally insured persons are entitled to a nationwide medication plan (BMP) under certain conditions (according to § 31a SGB V, E-Health Law). The catalogue of measures of the 3rd Action Plan 2013-2015 for the improvement of drug therapy safety (AMTS) provided for the testing of a medication plan in practice, including its acceptance and practicability in three model projects. These three projects - MetropolMediplan 2016, Erfurt, and PRIMA - are presented and recommendations are derived on the basis of the collected findings. Overall, the BMP was welcomed by the participating patients in all projects and led to an increase in satisfaction and an improvement in competence with regard to medication. Both doctors and pharmacists rated the interdisciplinary cooperation via the medium BMP very positively. The high effort and lack of technical infrastructure without electronic availability of the last current version of a BMP of the individual patient was perceived as negative. An original data comparison of the BMP data with the drugs actually taken in the MetropolMediplan 2016 project showed that only 36% of the patients were in agreement with the BMP and the drugs presently taken. The paper version of the BMP has therefore not yet been able to solve the problem of the timeliness and completeness of the medication. In addition to various proposals for the further development of BMP, all parties involved require the BMP to be available electronically across all sectors. The BMP should therefore be an important instrument for improving AMTS in the future.

Background Adverse drug reactions (ADR) are a common reason for emergency room visits and for hospitalization. An ADR is said to have occurred when the patient's symptoms and signs are considered to be possibly, probably, or definitely related to the intake of a drug. Methods In four large hospital emergency departments, one in each of four German cities ( Ulm, Furth, Bonn, and Stuttgart), the percentage of suspected ADR cases among all patients presenting to the emergency room was determined during a 30-day period of observation. ADRs were ascertained by screening the digital records of all patients seen in the emergency room; causality was assessed as specified by the WHO-UMC (Uppsala Monitoring Center). Results ADR were sought in a total of 10 174 emergency department visits. 665 cases of suspected ADR were found, yielding a prevalence of 6.5%. The prevalence of ADR among patients with documented drug intake was 11.6%. Among the patients with documented suspected ADRs, 89% were hospitalized (in contrast to the 43.7% hospitalization rate in the entire group of 10 174 emergency department visits). A possible causal relationship between the patient's symptoms and signs and the intake of a drug was found in 74-84% of cases. Patients with ADR were found to be taking a median of 7 different drugs simultaneously. Conclusion Adverse drug reactions are a relevant cause of emergency department visits, accounting for 6.5% of the total visits in this study, and often lead to hospital admission. The ADRED (Adverse Drug Reactions in Emergency Departments) study, which is now being conducted, is intended to shed further light on their causes, patient risk factors, and potential avoidability.

In Anbetracht der defizitaren finanziellen Lage von deutschen Notaufnahmen wurde die wirtschaftliche Situation einer Zentralen Notaufnahme (ZNA) bei der Versorgung ambulanter Falle untersucht. Hierbei kamen verschiedene medizinische Kategorisierungssysteme zum Einsatz − mit dem Ziel, die mit der Behandlung ambulanter Notfallpatienten einhergehenden Deckungsbeitrage insbesondere aus der ex ante-Sicht zu beleuchten. Auf Grundlage der Kostentragerrechnungsmethodik des Instituts fur das Entgeltsystem im Krankenhaus (InEK) wurden die fallbezogenen Ist-Kosten auf Vollkostenbasis fur 16.833 ambulante GKV-Patienten der ZNA des Klinikums Furth aus dem Jahr 2013 ermittelt und im Hinblick auf Dringlichkeit (ESI), Leitsymptome (CEDIS) und Diagnosen (ICD) analysiert. Den durchschnittlichen Fallkosten von 113,46 € stehen mittlere Fallerlose von 36,21 € gegenuber, woraus sich ein Fehlbetrag von − 77,26 € pro Fall errechnet. Fur keine der untersuchten Patientengruppen kann die Behandlung gewinnbringend bzw. zumindest kostendeckend erbracht werden. Der Ressourcenverbrauch bei der Behandlung eines Notaufnahmepatienten hangt stark von den medizinischen Entscheidungen ab, die ex ante, d. h. basierend auf Leitsymptom und Dringlichkeitskategorie, gefallt werden. In Anbetracht der Ergebnisse der vorliegenden Studie, der zufolge weder dringliche Patienten mit kritischen Leitsymptomen noch Falle mit unkritischen Symptomen und geringer Dringlichkeitsstufe kostendeckend behandelt werden konnen, sind die derzeitigen Vergutungsstrukturen kritisch zu hinterfragen.

Supplemental Digital Content is available in the text., Objectives The patient’s presenting complaint guides diagnosis and treatment in the emergency department, but there is no classification system available in German. The Canadian Emergency Department Information System (CEDIS) Presenting Complaint List (PCL) is available only in English and French. As translation risks the altering of meaning, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has set guidelines to ensure translational accuracy. The aim of this paper is to describe our experiences of using the ISPOR guidelines to translate the CEDIS PCL into German. Materials and methods The CEDIS PCL (version 3.0) was forward-translated and back-translated in accordance with the ISPOR guidelines using bilingual clinicians/translators and an occupationally mixed evaluation group that completed a self-developed questionnaire. Results The CEDIS PCL was forward-translated (four emergency physicians) and back-translated (three mixed translators). Back-translation uncovered eight PCL items requiring amendment. In total, 156 comments were received from 32 evaluators, six of which resulted in amendments. Conclusion The ISPOR guidelines facilitated adaptation of a PCL into German, but the process required time, language skills and clinical knowledge. The current methodology may be applicable to translating the CEDIS PCL into other languages, with the aim of developing a harmonized, multilingual PCL.

PURPOSE: 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. METHODS: A prospective observational study with three phases extending over 2 years was implemented in a 749 bed tertiary care hospital with an annual ED census of approximately 45 000 patients. The patient records of all adult non-trauma ED admissions were systematically analyzed by a team of emergency physicians, clinical pharmacologists, and pharmacists for potential ADE. Associated diagnosis related group costs were extracted from standardized accounting data. RESULTS: Of 2262 patients attending the ED during the study periods, the hospitalization of 366 patients (16.2%) was related to one or more caADEs of which 97.5% were considered predictable and 62.0% were classified as preventable. The mean caADE-related diagnosis related group costs were €2743 (95% bias-corrected and accelerated CI: €2498 to €3018). Extrapolated to a national scale, this corresponds to caADE-related costs of €2.245bn for the German health insurance funds, annually. Costs of €1.310bn could be attributed to events classified as predictable and preventable. CONCLUSIONS: In an ED, caADEs are frequent, and a significant proportion of these events and their related costs appear to be predictable and preventable. The ED as a first-line provider for ADE cases appears to be an appropriate environment to implement strategic and operative improvements for enhanced patient safety. Copyright © 2014 John Wiley & Sons, Ltd. Language: en

Adverse drug events (ADE) and medication errors (ME) are common causes of morbidity in patients presenting at emergency departments (ED). Recognition of ADE as being drug related and prevention of ME are key to enhancing pharmacotherapy safety in ED. We assessed the applicability of the Pareto principle (∼80 % of effects result from 20 % of causes) to address locally relevant problems of drug therapy. In 752 cases consecutively admitted to the nontraumatic ED of a major regional hospital, ADE, ME, contributing drugs, preventability, and detection rates of ADE by ED staff were investigated. Symptoms, errors, and drugs were sorted by frequency in order to apply the Pareto principle. In total, 242 ADE were observed, and 148 (61.2 %) were assessed as preventable. ADE contributed to 110 inpatient hospitalizations. The ten most frequent symptoms were causally involved in 88 (80.0 %) inpatient hospitalizations. Only 45 (18.6 %) ADE were recognized as drug-related problems until discharge from the ED. A limited set of 33 drugs accounted for 184 (76.0 %) ADE; ME contributed to 57 ADE. Frequency-based listing of ADE, ME, and drugs involved allowed identification of the most relevant problems and development of easily to implement safety measures, such as wall and pocket charts. The Pareto principle provides a method for identifying the locally most relevant ADE, ME, and involved drugs. This permits subsequent development of interventions to increase patient safety in the ED admission process that best suit local needs.

Summary Background: Information technology in health care has a clear potential to improve the quality and efficiency of health care, especially in the area of medication processes. On the other hand, existing studies show possible adverse effects on patient safety when IT for medication-related processes is developed, introduced or used inappropriately. Objectives: To summarize definitions and observations on IT usage in pharmacotherapy and to derive recommendations and future research priorities for decision makers and domain experts. Methods: This memorandum was developed in a consensus-based iterative process that included workshops and e-mail discussions among 21 experts coordinated by the Drug Information Systems Working Group of the German Society for Medical Informatics, Biometry and Epidemiology (GMDS). Results: The recommendations address, among other things, a stepwise and comprehensive strategy for IT usage in medication processes, the integration of contextual information for alert generation, the involvement of patients, the semantic integration of information resources, usability and adaptability of IT solutions, and the need for their continuous evaluation. Conclusion: Information technology can help to improve medication safety. However, challenges remain regarding access to information, quality of information, and measurable benefits.

Aims Computer-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. Methods A 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. Results A 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. Conclusions This 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.