Use of overactive bladder anticholinergic medications associated with falls leading to emergency department visits: results from the ADRED study.

PURPOSE: Drug intake might be a modifiable factor for the individual fall-risk of older adults, and anticholinergic properties of drugs need to be considered. This study is aimed at analyzing the association of older adults' individual anticholinergic load with particular focus on use of overactive bladder anticholinergic medications with falls in multi-medicated patients. MATERIALS AND METHODS: Cases of the prospective, observational, multi-center study on adverse drug reactions leading to emergency departments (ADRED study) between 2015 and 2018 in Germany were analyzed comparing the exposure of overactive bladder anticholinergic medications on the chance to present with a fall with patients without exposure. Logistic regression analysis was used adjusting for pre-existing conditions, drug exposure, and the individual anticholinergic burden by drug use. To this end, a combination of seven expert-based anticholinergic rating scales was used. RESULTS: The anticholinergic burden was higher in patients with overactive bladder anticholinergic medications (median 2 [1; 3]) compared to not taking drugs of interest. Presenting with a fall was associated with overactive bladder anticholinergic medications (odds ratio (OR) 2.34 [95% confidence interval 1.14-4.82]). The use of fall-risk increasing drugs was likewise associated (OR 2.30 [1.32-4.00]). The anticholinergic burden itself seemed not to be associated with falls (OR 1.01 [0.90-1.12]). CONCLUSIONS: Although falls occur multifactorial in older adults and confounding by indication cannot be ruled out, the indication for a drug treatment should be decided with caution when other, non-pharmacological treatment options have been tried. GERMAN CLINICAL TRIAL REGISTER: DRKS-ID: DRKS00008979, registration date 01/11/2017.

The phenotype of adverse drug effects: Do emergency visits due to adverse drug reactions look different in older people? Results from the ADRED study.

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.

Personalising drug safety-results from the multi-centre prospective observational study on Adverse Drug Reactions in Emergency Departments (ADRED).

PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: DRKS-ID: DRKS00008979.

Prevalence of Psychotropic Drugs in Cases of Severe Adverse Drug Reactions Leading to Unplanned Emergency Visits in General Hospitals.

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<0.001). The frequency of falls was almost 3 times higher than compared to the non-psychotropic drug group (10.5 vs. 3.9%, p<0.001), and similar syncope was also more often seen in the psychotropic drug users (8.8 vs. 5.5%, p=0.004). The use of psychotropic drugs increased the risk for falls by a factor of 2.82 (OR, 95% CI (1.90-4.18)), when adjusting for gender, age, numbers of pre-existing diseases, and drugs, respectively. 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.

Assessing healthcare service quality using routinely collected data: Linking information systems in emergency care.

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.

[Standardized national medication plan : The pilot projects MetropolMediplan 2016, model region Erfurt, and PRIMA]. / Der bundeseinheitliche Medikationsplan in der Praxis : Die Pilotprojekte MetropolMediplan 2016, Modellregion Erfurt und PRIMA.

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.

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

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.

Application of the Pareto principle to identify and address drug-therapy safety issues.

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

[OPTINOFA-Intelligent assistance service for structured assessment in the emergency department]. / OPTINOFA ­ Intelligenter Assistenzdienst zur strukturierten Ersteinschätzung in der Notaufnahme.

BACKGROUND: Case numbers in central emergency departments (EDs) have risen during the past decade in Germany, leading to recurrent overcrowding, increased risks in emergency care, and elevated costs. Particularly the fraction of outpatient emergency treatments has increased disproportionately. Within the framework of the Optimization of emergency care by structured triage with intelligent assistant service (OPTINOFA, Förderkennzeichen [FKZ] 01NVF17035) project, an intelligent assistance service was developed. PATIENTS AND METHODS: New triage algorithms were developed for the 20 most frequent leading symptoms on the basis of established triage systems (emergency severity index, ESI; Manchester triage system, MTS) and provided as web-based intelligent assistance services on mobile devices. To evaluate the validity, reliability, and safety of the new OPTINOFA triage instrument, a pilot study was conducted in three EDs after ethics committee approval. RESULTS: In the pilot study, n = 718 ED patients were included (age 59.1 ± 22 years; 349 male, 369 female). With respect to disposition (out-/inpatient), a sensitivity of 91.1% and a specificity of 40.7%, and a good correlation with the OPTINOFA triage levels were detected (Spearman's rank correlation ρ = 0.41). Furthermore, the area under the curve (AUC) for prediction of disposition according to the OPTINOFA triage level was 0.73. The in-hospital mortality rate of OPTINOFA triage levels 4 and 5 was 0%. The association between the length of ED stay and the OPTINOFA triage level was shown to be significant (p < 0.001). CONCLUSION: The results of the pilot study demonstrate the safety and validity of the new triage system OPTINOFA. By definition of both urgency and emergency care level, new customized perspectives for load reduction in German EDs via a closer cooperation between out- and inpatient sectors of emergency care could be established.

E-pharmacovigilance: development and implementation of a computable knowledge base to identify adverse drug reactions.

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.

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

AIMS: 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. METHODS: Based on clinical cases derived from an observational study we identified and classified common clinical problems that cannot be adequately characterized by the currently used definitions and algorithms. RESULTS: It appears that some key models currently used to describe the relation of medication errors (MEs), adverse drug reactions (ADRs) and adverse drug events (ADEs) can easily be misinterpreted or contain logical inconsistencies that limit their accurate use to all but the simplest clinical cases. A key limitation of current models is the inability to deal with complex interactions such as one drug causing two clinically distinct side effects or multiple drugs contributing to a single clinical event. Using a large set of clinical cases we developed a revised model of the interdependence between MEs, ADEs and ADRs and extended current event definitions when multiple medications cause multiple types of problems. We propose algorithms that may help to improve the identification, classification and counting of drug-related events. CONCLUSIONS: The new model may help to overcome some of the limitations that complex clinical cases pose to current paper- or software-based drug therapy safety.

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

AIMS: The aim was to improve medication safety in an emergency department (ED) by enhancing the integration and presentation of safety information for drug therapy. METHODS: Based on an evaluation of safety of drug therapy issues in the ED and a review of computer-assisted intervention technologies we redesigned an electronic case sheet and implemented computer-assisted interventions into the routine work flow. We devised a four step system of alerts, and facilitated access to different levels of drug information. System use was analyzed over a period of 6 months. In addition, physicians answered a survey based on the technology acceptance model TAM2. RESULTS: The new application was implemented in an informal manner to avoid work flow disruption. Log files demonstrated that step I, 'valid indication' was utilized for 3% of the recorded drugs and step II 'tooltip for well-known drug risks' for 48% of the drugs. In the questionnaire, the computer-assisted interventions were rated better than previous paper based measures (checklists, posters) with regard to usefulness, support of work and information quality. CONCLUSION: A stepwise assisting intervention received positive user acceptance. Some intervention steps have been seldom used, others quite often. We think that we were able to avoid over-alerting and work flow intrusion in a critical ED environment.

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

BACKGROUND: Although 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. METHODS: A 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. RESULTS: During 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. CONCLUSIONS: Methodologically, 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.

Systematic Review of Risk Factors Assessed in Predictive Scoring Tools for Drug-Related Problems in Inpatients.

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) <30 mL/min and age ≥60 years. The methodological approach and the individual risk factors presented in this review may provide a new starting point for improved risk assessment.

Documentation of Drug-Related Problems with ICD-11: Application of the New WHO Code-Set to Clinical Routine Data.

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.

Building the technical infrastructure to support a study on drug safety in a general hospital.

We describe reorganization steps and the required technical infrastructure to support a multidisciplinary research project aimed at improving the safety of drug therapy in an emergency department (ED) of a community hospital. Assessment of drug safety required consolidation of data from various sources in a single source approach. We solved this by transferring digital data from the hospital information system (HIS) and attached clinical systems into a pseudonymized study database (secuTrial), which is also used as a web based data capturing tool to rate drug associated risk situations, extended by a technical extension for dynamic upload of further data. Paper-based documentation in the ED was digitized using a digital pen technology.

CYP2D6 in the Brain: Potential Impact on Adverse Drug Reactions in the Central Nervous System-Results From the ADRED Study.

Cytochrome P450 (CYP) 2D6 is a polymorphic enzyme expressed in the central nervous system (CNS), important in drug metabolism and with a potentially constitutive role in CNS function such as vigilance. This study aimed to analyze variability in CYP2D6 activity linked to vigilance-related adverse drug reactions (ADRs) in the CNS. A dataset of N = 2939 ADR cases of the prospective multicenter observational trial in emergency departments (EDs) (ADRED; trial registration: DRKS-ID: DRKS00008979) was analyzed. Dizziness as the most frequent reported CNS ADR symptom (12.7% of patients, n = 372) related to vigilance was chosen as the outcome. The association of dizziness with CYP2D6 activity markers was analyzed. The number of CYP2D6 substrates taken, a CYP2D6 saturation score (no, moderate, and strong saturation), a CYP2D6 saturation/inhibition score (no, weak, moderate, and strong), and composed CYP2D6 activity using a genotyped subsample (n = 740) calculating additive effects of genotype and CYP2D6 saturation by drug exposure were used as CYP2D6 activity markers. Effects were compared to other frequent nonvigilance-related CNS ADR symptoms (syncope and headache). Secondary analyses were conducted to control for other ADR symptoms frequently associated with dizziness (syncope, nausea, and falls). The majority of all patients (64.5%, n = 1895) took at least one drug metabolized by CYP2D6. Around a third took a CNS drug (32.5%, n = 955). The chance to present with drug-related dizziness to the ED increased with each CYP2D6 substrate taken by OR 1.11 [1.01-1.23]. Presenting with drug-related dizziness was more likely with CYP2D6 saturation and saturation/inhibition (both OR 1.27 [1.00-1.60]). The composed CYP2D6 activity was positively associated with dizziness (p = 0.028), while poorer activity affected patients more often with dizziness as an ADR. In contrast, nonvigilance-related ADR symptoms such as syncope and nausea were not consistently significantly associated with CYP2D6 activity markers. This study shows an association between the number of CYP2D6 substrates, the predicted CYP2D6 activity, and the occurrence of dizziness as a CNS ADR symptom. As dizziness is a vigilance-related CNS symptom, patients with low CYP2D6 activity might be more vulnerable to drug-related dizziness. This study underlines the need for understanding individual drug metabolism activity and individual risks for ADRs.

S2k guideline diagnosis and treatment of carbon monoxide poisoning.

Carbon monoxide (CO) can occur in numerous situations and ambient conditions, such as fire smoke, indoor fireplaces, silos containing large quantities of wood pellets, engine exhaust fumes, and when using hookahs. Symptoms of CO poisoning are nonspecific and can range from dizziness, headache, and angina pectoris to unconsciousness and death. This guideline presents the current state of knowledge and national recommendations on the diagnosis and treatment of patients with CO poisoning. The diagnosis of CO poisoning is based on clinical symptoms and proven or probable exposure to CO. Negative carboxyhemoglobin (COHb) levels should not rule out CO poisoning if the history and symptoms are consistent with this phenomenon. Reduced oxygen-carrying capacity, impairment of the cellular respiratory chain, and immunomodulatory processes may result in myocardial and central nervous tissue damage even after a reduction in COHb. If CO poisoning is suspected, 100% oxygen breathing should be immediately initiated in the prehospital setting. Clinical symptoms do not correlate with COHb elimination from the blood; therefore, COHb monitoring alone is unsuitable for treatment management. Especially in the absence of improvement despite treatment, a reevaluation for other possible differential diagnoses ought to be performed. Evidence regarding the benefit of hyperbaric oxygen therapy (HBOT) is scant and the subject of controversy due to the heterogeneity of studies. If required, HBOT should be initiated within 6 h. All patients with CO poisoning should be informed about the risk of delayed neurological sequelae (DNS).

Drug utilisation on a preterm and neonatal intensive care unit in Germany: a prospective, cohort-based analysis.

PURPOSE: This study aims to describe the drug use on a Neonatal Intensive Care Unit (NICU) at a University Children's Hospital in Germany, to investigate the licensing status of the drugs used and to conclude critical areas in neonatal intensive care to support prioritisation of future research. METHODS: An 11-month, prospective cohort study was conducted on the NICU at the University Children's Hospital Erlangen, Germany. All products prescribed during the study period were analysed whether or not the SPC contains information on term and preterm neonates. RESULTS: A total of 183 patients (102 male) with a mean gestational age of 33.6 weeks (minimum = 24, maximum = 42) were included. The mean length of hospitalisation was 19.4 days (minimum = 2, maximum = 167). On average, patients received 11.1 drugs (minimum = 0, maximum = 46). The majority of prescriptions were accounted for by antibiotics (n = 515), which were received by 90% of all patients, followed by CNS drugs (n = 448) and respiratory drugs (n = 306). Of all the different drugs prescribed (n = 102) only 38% had information regarding their use in patients aged less than 1 month in their SPC. Analgesics and cardiovascular drugs were prescribed frequently, but without having information for use in neonates. Seventy percent of all patients and 100% of very preterm infants received at least one of these drugs. CONCLUSIONS: Treatment strategies on a preterm intensive care unit are complex and little information is available for the drugs used. Analgesics and cardiovascular drugs are of major concern. Efforts will have to be made to conduct well-designed and powered studies in this vulnerable population.

Quality indicators for a geriatric emergency care (GeriQ-ED) - an evidence-based delphi consensus approach to improve the care of geriatric patients in the emergency department.

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.