Costs of Adverse Drug Events in German Hospitals—A Microcosting Study

AbstractObjectiveIn Germany, only limited data are available to quantify the attributable resource utilization associated with adverse drug events (ADEs). The aim of this study was twofold: first, to calculate the direct treatment costs associated with ADEs leading to hospitalization and, second, to derive the excess costs and extra hospital days attributable to ADEs of inpatient treatments in selected German hospitals.MethodsThis was a retrospective and medical record–based study performed from the hospitals' perspective based on administrative accounting data from three hospitals (49,462 patients) in Germany. Total treatment costs (“analysis 1”) and excess costs (i.e., incremental resource utilization) between patients suffering from an ADE and those without ADEs were calculated by means of a propensity score–based matching algorithm (“analysis 2”).ResultsMean treatment costs (“analysis 1”) of ADEs leading to hospitalization (n = 564) were €1,978 ± 2,036 (range €191–18,147; median €1,446; €843–2,480 [Q1–Q3]). In analysis 2, the mean costs of inpatients suffering from an ADE (n = 1,891) as a concomitant disease or complication (€5,113 ± 10,059; range €179–246,288; median €2,701; €1,636–5,111 [Q1–Q3]) were significantly higher (€970; P < 0.0001) than those of non-ADE inpatients (€4,143 ± 6,968; range €154–148,479; median €2,387; €1,432–4,701 [Q1–Q3]). Mean inpatient length of stay of ADE patients (12.7 ± 17.2 days) and non-ADE patients (9.8 ± 11.6 days) differed by 2.9 days (P < 0.0001). A nationwide extrapolation resulted in annual total treatment costs of €1.058 billion.ConclusionsThis is one of the first administrative data–based analyses calculating the economic consequences of ADEs in Germany. Further efforts are necessary to improve pharmacotherapy and relieve health care payers of preventable treatment costs

Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees

Background: In the course of the COVID-19 pandemic, the biomedical research community's attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees (RECs). Methods: We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. Results: We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding (1) social value (e.g. lack of coordination), (2) scientific validity (e.g. provisional study planning), (3) favourable risk-benefit ratio (e.g. difficult benefit assessment), (4) informed consent (e.g. strict isolation measures), (5) independent review (e.g. lack of time), (6) fair selection of trial participants (e.g. inclusion of vulnerable groups), and (7) respect for study participants (e.g. data security). Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. Conclusions: RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies

Implementation of a renal pharmacist consultant service: information sharing in paper versus digital form

What is known and objective Renal impairment (RI) and renal drug-related problems (rDRP) often remain unrecognized in the community setting. A “renal pharmacist consultant service” (RPCS) at hospital admission can support patient safety by detecting rDRP. However, the efficient information sharing from pharmacists to physicians is still discussed. The aim of the study was to test the implementation of a RPCS and its effectiveness on prescription changes and to evaluate two ways of written information sharing with physicians. Methods Urological patients with eGFRnon-indexed of 15-59 ml/min and ≥1 drug were reviewed for manifest and potential rDRP at admission by a pharmacist. Written recommendations for dose or drug adaptation were forwarded to physicians comparing two routes: July-September 2017 paper form in handwritten chart; November 2017-January 2018 digital PDF document in the electronic patient information system and e-mail alert. Prescription changes regarding manifest rDRP were evaluated and compared with a previous retrospective study without RPCS. Results and discussion The RPCS detected rDRP in 63 of 234 (26.9%) patients and prepared written recommendations (median 1 rDRP (1-5) per patient) concerning 110 of 538 (20.5%) drugs at admission. For manifest rDRP, acceptance rates of recommendations were 62.5% (paper) vs 42.9% (digital) (P = 0.16). Compared with the retrospective study without RPCS (prescription changes in 21/76 rDRP; 27.6%), correct prescribing concerning manifest rDRP significantly increased by 27.1%. What is new and conclusion A RPCS identifies patients at risk for rDRP and significantly increases appropriate prescribing by physicians. In our hospital (no electronic order entry, electronic chart or ward pharmacists), consultations in paper form seem to be superior to a digital PDF document

Antiepileptic Drugs and Suicide: A Systematic Review of Adverse Effects

&lt;b&gt;&lt;i&gt;Background:&lt;/i&gt;&lt;/b&gt; Since the FDA (Food and Drug Administration) report on antiepileptic drugs (AEDs) and suicide risk was released (2008), several studies have been published on this controversial relationship. This systematic review (SR) gives an updated approach to this health issue. &lt;b&gt;&lt;i&gt;Summary:&lt;/i&gt;&lt;/b&gt; We searched 6 databases. We ultimately included 11 publications: 4 cohort studies, 1 case-crossover study, 2 community case-control studies, and 4 SRs. Overall, 1 SR described studies already included; 3 studies reported a 2- to 4-fold overall increase in risk; 1 study reported an increased risk of suicide among epilepsy patients on AEDs with high risk of depression; 1study showed a protective effect among epilepsy patients; 2 studies were conducted with patients with bipolar disorder (1 showed a protective effect, whereas the other showed a 3-fold increase in risk of suicide), and the other 3 studies reported results for single AEDs. Several biases affected the published results. &lt;b&gt;&lt;i&gt;Key Messages:&lt;/i&gt;&lt;/b&gt; There is no clear evidence of an association between the use of AEDs and an increased risk of suicide because of the heterogeneity in the studies at the clinical and methodological level. A future study should cover all indications for use, retrieve information from a healthcare database, and include a defined set of covariates to avoid bias.</jats:p

Prescribing of long-acting beta-2-agonists/inhaled corticosteroids after the SMART trial

Background After the SMART trial evaluating the safety of salmeterol (long-acting beta-2-agonist (LABA)) in asthma patients, regulatory actions were taken to promote a guideline-adherent prescribing of LABA only to patients receiving inhaled corticosteroids (ICS). We aim to analyse LABA- and ICS-related prescription patterns after the SMART trial in Germany. Methods Patients documented in the Bavarian Association of Statutory Health Insurance Physicians database (approximately 10.5 million people) were included if they had a diagnosis of asthma and at least one prescription of LABA and/or ICS between 2004 and 2008. Annual period prevalence rates (PPRs) were estimated and Cochrane Armitage tests were used for time trend analyses. Results Highest annual PPRs were found for budesonide and the fixed combination of salmeterol/fluticasone. The proportion of “concomitant LABA and ICS users” increased from 52.0 to 57.6% within the study period, whereas for “LABA users without ICS” a slight decrease from 6.5 to 5.4% was found. In 2008, the proportion of patients with at least one quarter with a LABA prescription without concomitant ICS was highest in elderly, male patients (≈20%). In the majority of these patients, a concomitant diagnosis of COPD (i.e. asthma-COPD overlap syndrome [ACOS]) was present. Conclusions Between 2004 and 2008, we found a moderate increase in guideline-adherent LABA prescribing in a representative German population. Elderly men received a significant number of LABA prescriptions without concomitant ICS probably due to ACOS

Феномен веры в мистическом опыте просветления

В статье исследуется феномен религиозной веры и делается вывод о существовании двух ее уровней. Первый из них - "вера просительная" (со многим количеством условий), характерна для человека, воспринимающего себя как смертное Тело-Эго и ориентированного на страх. Совершенной формой религиозной веры может считаться только "вера абсолютная" (безусловная), достижение которой является основной целью мистической практики просветления. Она характеризуется полным уничтожением Эго, формированием безусловного доверия и любви к Богу. Вера в имманентных мистических учениях приобретает форму доверия к своему истинному "Я"-Атману. Вера в трансцендентно-имманентной мистике приобретает форму доверия к трансцендентной силе, что подразумевает безусловную отдачу Ее воле.У статті проводиться дослідження феномену релігійної віри. Робиться висновок про існування двох її рівнів. Перший з них - "віра прохальна" (з багатьма умовами), характерна для людини, що сприймає себе як смертне Тіло-Его та зорієнтована на страх. Досконалою формою релігійної віри можна вважати тільки "віру абсолютну" (безумовну), досягнення якої постає основною метою містичної практики просвітлення. Цей рівень віри характеризується повним знищенням Его, формуванням безумовної довіри та любові до Бога. Віра у іманентних містичних ученнях має форму довіри до свого істинного "Я"-Атману. Віра в трансцендентно-іманентній містиці приймає форму довіри до трансцендентної сили, що вимагає безумовної віддачі Її волі.The phenomenon of religious faith is investigated in the article. The conclusion is that there are two levels of it. First of them is "faith-request" (with a number of conditions), it is typical for a person who perceives oneself as a mortal Body - Ego and who is orientated on fear. Just "absolute faith" (unconditional) can be considered to be a perfect form of religious faith, and the achievement of it is the main purpose of mystical practice of enlightening. It is characterized with complete destroying of Ego, with forming of unconditional trust and love to God. Faith in immanent mystical teachings acquires the form of trust to own true "I" - Atman. Faith in transcendental immanent mystics acquires the form of trust to transcendental power that means unconditional exposing to His will

The EUTOS long-term survival (ELTS) score is superior to the Sokal score for predicting survival in chronic myeloid leukemia

Prognostic scores support clinicians in selecting risk-adjusted treatments and in comparatively assessing different results. For patients with chronic-phase chronic myeloid leukemia (CML), four baseline prognostic scores are commonly used. Our aim was to compare the prognostic performance of the scores and to arrive at an evidence-based score recommendation. In 2949 patients not involved in any score development, higher hazard ratios and concordance indices in any comparison demonstrated the best discrimination of long-term survival with the ELTS score. In a second step, of 5154 patients analyzed to investigate risk group classification differences, 23% (n = 1197) were allocated to high-risk by the Sokal score. Of the 1197 Sokal high-risk patients, 56% were non-high-risk according to the ELTS score and had a significantly more favorable long-term survival prognosis than the 526 high-risk patients according to both scores. The Sokal score identified too many patients as high-risk and relatively few (40%) as low-risk (versus 60% with the ELTS score). Inappropriate risk classification jeopardizes optimal treatment selection. The ELTS score outperformed the Sokal score, the Euro, and the EUTOS score regarding risk group discrimination. The recent recommendation of the European LeukemiaNet for preferred use of the ELTS score was supported with significant statistical evidence

Differences in treatment and monitoring of chronic myeloid leukemia with regard to age, but not sex: Results from a population-based study

There are established guidelines for treatment and monitoring of chronic myeloid leukemia (CML) but little is known about routine care. Data on ICD-10 codes as well as prescribed medications were available for 10.5~million patients in the statutory health insurance system in Bavaria for the years 2010 to 2016. Also, data on the molecular and cytogenetic monitoring were integrated. A total of 1714 adult patients with CML were observed. Only 50.8% received more than 67.5 daily doses per quarter year (target: 91.5) while 18.2% did not receive any tyrosine kinase inhibitor (TKI). The median number of daily doses was at least 80 doses per quarter year for all age groups in men, but decreased to 62 doses in elderly women. With this exception, no differences between men and women were observed. The percentage of patients without any TKI increased with age. The median number of molecular examinations was 3.54 independent of age and sex. Even in a highly developed country, still a considerable number of patients with CML seem to not receive adequate treatment, whereas molecular monitoring can be considered satisfactory

История изучения имен прилагательных в крымскотатарском языке

Целью данной статьи является рассмотрение степени изученности имени прилагательного в крымскотатарском языке как самостоятельной части речи в лингвистических трудах XIX – XX вв., а также анализ основных грамматических категорий имени прилагательного

Етнологія релігії – актуальна сфера українського релігієзнавства

Background: Inhaled long-acting beta-2-adrenoceptor agonists (LABA) are frequently used in patients suffering from asthma and chronic obstructive pulmonary disease (COPD). For evaluation of real-life data, drug consumption studies are needed but results might be widely influenced due to methodological differences in particular regarding inter-country comparisons. Objectives: This study aims to compare the LABA prescribing in the general population and specifically in patients suffering from asthma and/or COPD in five European countries. Methods: Crude and age- and sex-standardized (European 2008 reference population) annual period prevalence rates per 10,000 persons were calculated for the period 2002-2009 based on seven European electronic health record databases (Denmark, Germany, Spain, the Netherlands (2), and the United Kingdom (2)). Stratification by sex, age, and indication were performed for the annual period prevalence rates. Results: In all databases, we observed an increase in LABA prescriptions during the study period for the general population and for patients suffering from asthma and/or COPD. In 2008, the highest standardized period prevalence was observed in the Dutch Mondriaan-AHC and the Spanish BIFAP database (443.3 and 395.5 per 10,000 persons), and the lowest in the German Bavarian Claims and Dutch Mondriaan- NPRCD database (278.7 and 290.6 per 10,000 persons). Prevalence rates for LABA increased with age and were highest in patients over 70 years. Patients with a combined diagnosis of asthma and COPD had higher prevalence rates of LABA compared to patients with a single diagnosis of asthma or COPD. The proportion of patients with one inhaled LABA prescription only ranged from 14% (UK databases) to 35% (Spanish BIFAP database) in 2008 in the general population. Conclusions: By using a standardized protocol, we demonstrated inter- and intra-country differences in LABA prescriptions. A general increase of LABA prescriptions during the study period was observed in all databases