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Structured analyses of hospital administrative data may detect potentially preventable adverse drug events (ADE) and therefore are considered promising sources to prevent future harm and estimate cost savings. Whether results of these analyses indeed correspond to ADE that may be preventable in clinical routines needs to be verified. We exemplarily screened all adult inpatients admitted to a German University Hospital (n = 54,032) for International Classification of Diseases-10th revision (ICD-10) diagnoses coding for drug-induced kidney injury (AKI). In a retrospective chart review, we checked the coded adverse events (AE) for inhospital occurrence, causality to drug exposure, and preventability in all identified cases and calculated positive predictive values (ppv). We identified 69 inpatient cases of whom 41 cases (59.4%) experienced the AE in the hospital (ppv-range 0.43-0.80). Causality assessment revealed a rather likely causal relationship between AE and drug exposure in 11 cases (15.9, 11/69, ppv-range 0.17-0.22) whereby preventability measures could be postulated for seven cases (10.1%, 7/69). Focusing on drug-induced AKI, this study exemplarily underlines that ICD-10-code-based ADE prevention efforts are quite limited due to the small identification rate and its high proportion of primarily outpatient events. Furthermore, causality assessment revealed that cases are often too complex to benefit from generic prevention strategies. Thus, ICD-10-code-based calculations might overestimate patient harm and economic losses.

More than 30% of all patients undergoing surgery suffer from preoperative anemia. Iron deficiency anemia is the most common type of anemia. The diagnostics and treatment of iron deficiency anemia can be carried out before patients undergo surgery as an alternative to blood transfusion and is an interdisciplinary task. This article gives an overview of various billing modalities and payment arrangements for management of preoperative anemia in the German healthcare system.

Purpose: Using clinical administrative data (CAD) of inpatients, we aimed to identify ICD-10 codes coding for potentially preventable inhospital adverse drug events (ADE) that affect the length of hospital stay (LOS) and thus patient well-being and cost., Methods: We retrospectively assessed CAD of all inpatient stays in 2012 of a German university hospital. Predefined ICD-10 codes indicating ADE (ADE codes) were further specified based on expert ratings of the ADE mechanism and ADE preventability in clinical routine to particularly identify preventable inhospital ADE. In a propensity-matched cohort design, we compared patients with one or more ADE codes to control patients with regard to differences in LOS for three situations: all cases with an ADE code, cases with an inhospital ADE code, and cases with a preventable inhospital ADE code., Results: Out of 54 032 cases analysed, in 8.3% (N=4 462) at least one ADE code was present. Nine of 128 evaluated ADE codes were rated as preventable in clinical routine, relating to 220 inpatients (4.9% of all identified inpatients with at least one ADE code and 0.4% of the entire cohort, respectively). Out of 48 072 evaluable inpatients for propensity score matching, 7 938 controls without ADE code and 4 006 cases with ADE code were selected. In all three settings, cases showed prolonged LOS vs controls (delta 1.13 d; 0.88 d and 1.88 d, respectively), significantly exceeding the maximum LOS as defined for each Diagnosis-Related Group., Conclusion: Inpatients with ADE codes referring to inhospital, potentially preventable ADE exceeded the maximum hospital stay fully reimbursed by insurance companies, indicating unnecessary long and costly inpatient stays., (© 2017 John Wiley & Sons Ltd.)

Introduction: Prescription forms enable the communication between physicians and pharmacists. Hence, incorrectly issued prescriptions may result in delay of health-care delivery, additional workload, and potentially adverse patient outcomes. We aimed to evaluate the formal prescription quality in our outpatient clinics (OC) before and after performing teaching sessions and using an electronic prescription system to replace handwritten prescriptions., Methods: All OCs of a university hospital were offered a short teaching session on how to issue prescriptions correctly and how to use the electronic prescription system. During four weeks before and after the teaching, we anonymously collected all prescriptions of the OCs in 20 surrounding community pharmacies and assessed whether they were error-free, required an intervention by the pharmacist, additional clarification by the OC, or had to be reissued., Results: After the intervention, the absolute fraction of formally error-free prescriptions increased by 12.9% from 52.9% (516/976) to 65.8% (713/1084, p < 0.001; d = 12,9% 95% confidence interval [8,7%; 17,1%]). Largest improvements were seen in prescriptions requiring clarification by the OC (224/976 prescriptions at baseline versus 93/1084 post-intervention, p < 0.001). The fraction of electronic prescriptions increased from 34.9% (341/976) to 46.9% (509/1084, p < 0.001, d = 12,0% 95% confidence interval [7,8%; 16,2%]) with electronic prescriptions consistently being of higher formal quality than handwritten prescriptions., Conclusion: After increased use of electronic prescribing and teaching courses, formal prescription quality was significantly improved., (© Georg Thieme Verlag KG Stuttgart · New York.)

The concept of patient safety is more of a presence in modern day medicine than ever before. All measures and processes aiming at preempting and preventing critical incidents and accidents in patient care are collectively grouped under this concept. With the Declaration of Helsinki in 2010 modern anesthesiology has undertaken a fundamental role in the clinical implementation and perioperative clinicians are confronted with a multitude of theories, models, methods and tools targeted at improving or facilitating optimized patient safety. One of the biggest challenges lies in their synergistic combination to create a functioning concept for perioperative risk management while also incorporating individual strengths and weaknesses. The aim of the present paper is to provide a structured overview of the various components presently available for increasing perioperative patient safety.

Purpose: The optimal regimen to prevent chemotherapy-induced nausea and vomiting (CINV) for patients undergoing high-dose chemotherapy and autologous stem-cell transplantation (ASCT) is unclear. To evaluate the effect of aprepitant in addition to a standard regimen, we conducted this randomized, placebo-controlled phase III trial., Patients and Methods: Patients with multiple myeloma were randomly assigned at a one-to-one ratio to receive either aprepitant (125 mg orally on day 1 and 80 mg orally on days 2 to 4), granisetron (2 mg orally on days 1 to 4), and dexamethasone (4 mg orally on day 1 and 2 mg orally on days 2 to 3) or matching placebo, granisetron (2 mg orally on days 1 to 4), and dexamethasone (8 mg orally on day 1 and 4 mg orally on days 2 to 3). Melphalan 100 mg/m(2) was administered intravenously on days 1 to 2. ASCT was performed on day 4. The primary end point (complete response) was defined as no emesis and no rescue therapy within 120 hours of melphalan administration. Quality of life was assessed by modified Functional Living Index-Emesis (FLIE) questionnaire on days -1 and 6., Results: Overall, 362 patients were available for the efficacy analysis (181 in each treatment arm). Significantly more patients receiving aprepitant reached the primary end point (58% v 41%; odds ratio [OR], 1.92; 95% CI, 1.23 to 3.00; P = .0042). Absence of major nausea (94% v 88%; OR, 2.37; 95% CI, 1.09 to 5.15; P = .026) and emesis (78% v 65%; OR, 1.99; 95% CI, 1.25 to 3.18; P = .0036) within 120 hours was increased by aprepitant. Mean total FLIE score (± standard deviation) was 114 ± 18 for aprepitant and 106 ± 26 for placebo (P < .001)., Conclusion: The addition of aprepitant resulted in significantly less CINV and had a positive effect on quality of life., (© 2014 by American Society of Clinical Oncology.)

Invasive fungal disease (IFD) causes increasing morbidity and mortality in haematological cancer patients. Reliable cost data for treating IFD in German hospitals is not available. Objective of the study was to determine the institutional cost of treating the IFD. Data were obtained by retrospective chart review in German hospitals. Patients had either newly diagnosed or relapsed acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS). Direct medical cost was calculated from hospital provider's perspective. A total of 108 patients were enrolled at 5 tertiary care hospitals, 36 IFD patients and 72 controls. The vast majority of IFD patients (74%) were diagnosed with invasive aspergillosis. On average, the hospital stay for IFD patients was 12 days longer than in control patients. All patients in the IFD group and 89% of patients in the control group received antifungal drugs. Mean direct costs per patient were €51,517 in the IFD group and €30,454 in the control group. Incremental costs of €21,063 were dominated by cost for antifungal drugs (36%), hospital stay (32%) and blood products (23%). From the perspective of hospitals in Germany the economic burden of IFD in patients with AML or MDS is substantial. Therefore, prevention of IFD is necessary with respect to both clinical and economic reasons., (© 2012 Blackwell Verlag GmbH.)

Background: Routine prophylactic platelet transfusion is the standard of care for patients with severe thrombocytopenia. We assessed the effect of a new strategy of therapeutic platelet transfusion on the number of transfusions and safety in patients with hypoproliferative thrombocytopenia., Methods: We did a multicentre, open-label, randomised parallel-group trial at eight haematology centres in Germany. Patients aged 16-80 years, who were undergoing intensive chemotherapy for acute myeloid leukaemia or autologous haemopoietic stem-cell transplantation for haematological cancers, were randomly assigned via a computer-generated randomisation sequence to receive either platelet transfusion when bleeding occurred (therapeutic strategy) or when morning platelet counts were 10×10(9) per L or lower (prophylactic strategy). Investigators undertaking interventions were not masked to group assignment. The primary endpoint was the number of platelet transfusions. Analysis was by intention to treat. This trial is registered, NCT00521664., Findings: 197 patients were assigned the prophylactic strategy and 199 the therapeutic strategy. Of 391 patients analysed, the therapeutic strategy reduced the mean number of platelet transfusions by 33·5% (95% CI 22·2-43·1; p<0·0001) in all patients (2·44 [2·22-2·67] in prophylactic group vs 1·63 [1·42-1·83] in therapeutic group), 31·6% (18·6-42·6; p<0·0001) in those with acute myeloid leukaemia (2·68 [2·35-3·01] vs 1·83 [1·58-2·10]), and 34·2% (6·6-53·7; p=0·0193) in those who had had autologous transplantation (1·80 [1·45-2·15] vs 1·18 [0·82-1·55]. We noted no increased risk of major haemorrhage in patients who had undergone autologous transplantation. In those with acute myeloid leukaemia, risk of non-fatal grade 4 (mostly CNS) bleeding was increased. We recorded 15 cases of non-fatal haemorrhage: four retinal in each transfusion group, and one vaginal and six cerebral in the therapeutic group. 12 patients died in the study: two from fatal cerebral haemorrhages in the therapeutic group, and ten (five in each treatment group) unrelated to major bleeding., Interpretation: The therapeutic strategy could become a new standard of care after autologous stem-cell transplantation; however, prophylactic platelet transfusion should remain the standard for patients with acute myeloid leukaemia. The new strategy should be used by some haematology centres only if the staff are well educated and experienced in the new approach and can react in a timely way to first signs of CNS bleeding., Funding: Deutsche Krebshilfe eV (German Cancer Aid)., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

In 2003 a new reimbursement system was established for German hospitals. The approximately 17 million inpatient cases per year are now reimbursed based on a per-case payment regarding diagnoses and procedures, which was developed from an internationally approved system. The aim was a better conformity of costs and efforts in in-patient cases. In the first 2 years after implementation, the German diagnosis-related group (DRG) system was not able to adequately represent the complex structures of treatment in hematological and oncological in-patients. By creating new diagnoses and procedures (International Classification of Diseases 10 (ICD-10) and Surgical Operations and Procedures Classification System (OPS) catalogues), generating new DRGs and better splitting of existing ones, the hematology and oncology field could be much better described in the following years. The implementation of about 70 'co-payment structures' for new and expensive drugs and procedures in oncology was also crucial. To reimburse innovations, an additional system of co-payments for innovations was established to bridge the time until innovations are represented within the DRG system itself. In summary, hematological and oncological in-patients, including cases with extraordinary costs, are meanwhile well mapped in the German reimbursement system. Any tendencies to rationing could thereby be avoided, as most of the established procedures and costly drugs are adequately represented in the DRG system., (Copyright © 2011 S. Karger AG, Basel.)

The discovery of human embryonic stem cells at the end of 1998 had a strong influence on the development of stem cell research and led to controversial discussions. The first therapeutic application of adult blood stem cells began after their discovery in 1963 and was accepted as an authorized therapy in the early 1980s. The way from basic research to therapeutic use needed about 20 years and was also discussed in a controversial way similar to the discussions of today. The regulatory environment at that time, however, allowed a quick translation of the results from basic research to the clinic. Today many new stem cell therapies for a multitude of diseases are under development. Their clinical realization is regulated by the AMG (Arzneimittelgesetz). For nonclinical research as well as for clinical research, specific regulations are enacted to guarantee a structured and safe launch. Time, know how and money for planning, request for authorization and conduction of a clinical trial should not be underestimated. For clinical application of stem cell products authorization by the proper authorities is mandatory.

Objectives: In the department of internal medicine of Heidelberg University Hospital (HUH), medical patient records are archived electronically. Since there are still paper-based external documents, a temporary patient record is maintained for these documents during the patient's stay. Afterwards, the paper-based documents are scanned, indexed and integrated in the electronic patient record (EPR). To ensure process quality we evaluated quality and availability of scanned documents in the EPR., Methods: Observation study, structured interviews, systematic quantitative before-after comparison., Results: The workflow takes place according to the guidelines of HUH. Nevertheless, there are variations in the different wards which may influence the quality. Of 343 scanned documents about 90% showed no loss of information. Most of the documents with loss of information were ECG-curves. Four documents (1.2%) could not be found in the EPR. All documents were assigned to the correct patient and episode of care. The mean time from patient discharge to availability of scanned documents in the EPR system was 36 days., Conclusions: Due to external paper-based documents, a complete EPR is currently not possible. A temporary paper-based patient record in addition to the EPR is not an optimum procedure but feasible. The quality of the scanned, indexed and integrated documents in the EPR is high and the availability is sufficient.

Although reduced intensity conditioning (RIC) before allografting is associated with low treatment-related morbidity and mortality, graft-versus-host disease (GVHD) remains a significant complication of hematopoietic stem cell transplantation (HSCT). T cell depletion (TCD) has been successfully used in conventional allotransplantation to reduce the incidence of GVHD, but was associated with an increased rate of engraftment failure. In a small cohort of six patients at high risk of developing GVHD we have determined whether sustained engraftment could be achieved using reduced intensity conditioning and T cell depletion in combination. All patients engrafted and 5/6 developed high levels (i.e. > or =95%) of donor chimerism, even though mismatched related or matched unrelated donors were used. Only one patient developed acute GVHD, as he received donor lymphocyte infusions (DLI) for relapse. In summary, TCD might be a useful prophylactic tool in RIC allogeneic HSCT. Although TCD after RIC might be associated with high relapse rate, as 5/6 patients are not in remission, this combined strategy might be appropriate for patients with less aggressive malignant or non-malignant diseases in which high transplant-related morbidity and mortality is not acceptable.