Background: Calprotectin is present in the cytosol of neutrophil granulocytes and released upon activation. Fecal calprotectin is applied in the clinical management of inflammatory bowel disease whereas serum calprotectin has been discussed as a biomarker in inflammatory disorders. However, its long-term prognostic relevance in critical illness remains unclear. Our aim was to investigate serum calprotectin concentrations as a prognostic biomarker in critically ill and septic patients. Methods: Serum calprotectin concentrations were analyzed in 165 critically ill patients (108 with sepsis, 57 without sepsis) included in our observational study. Patients were enrolled upon admission to the medical intensive care unit (ICU) of the RWTH Aachen University Hospital. Calprotectin concentrations were compared to 24 healthy controls and correlated with clinical parameters, therapeutic interventions, and survival. Results: Serum calprotectin concentrations were significantly increased in ICU patients as well as in septic patients compared to respective controls (p < 0.001 for ICU patients and p = 0.001 for septic patients). Lower calprotectin concentrations were measured in patients with comorbidities i.e., coronary artery disease. Calprotectin concentrations strongly correlated with the C-reactive protein (p < 0.001) and were closely associated to parameters of mechanical ventilation (i.a. inspiratory oxygen fraction, FiO₂; p < 0.001). The overall survival was significantly impaired in septic patients with high baseline calprotectin concentrations (p = 0.036). However, patients with increasing calprotectin serum concentrations within the first week of ICU admission showed an improved overall survival (p = 0.009). Conclusions: In summary, serum calprotectin concentrations are significantly increased in critically ill patients with sepsis. High calprotectin concentrations at ICU admission predict long-term mortality risk, whereas increasing calprotectin concentrations are associated with a favorable long-term outcome.

Objectives: Pediatric inpatients are particularly vulnerable to medication errors (MEs), especially in highly individualized preparations like parenteral nutrition (PN). Aside from prescribing via a computerized physician order entry system (CPOE), we evaluated the effect of cross-checking by a clinical pharmacist to prevent harm from PN order errors in a neonatal and pediatric intensive care unit (NICU/PICU). Methods: The incidence of prescribing errors in PN in a tertiary level NICU/PICU was surveyed prospectively between March 2012 and July 2013 (n = 3012 orders). A pharmacist cross-checked all PN orders prior to preparation. Errors were assigned to seven different error-type categories. Three independent experts from different academic tertiary level NICUs judged the severity of each error according to the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index (categories A-I). Results: The error rate was 3.9 % for all 3012 orders (118 prescribing errors in 111 orders). 77 (6.0 %, 1277 orders) errors occurred in the category concentration range, all concerning a relative overdose of calcium gluconate for peripheral infusion. The majority of all events (60 %) were assigned to categories C and D (without major harmful consequences) while 28 % could not be assigned due to missing majority decision. Potential harmful consequences requiring interventions (category E) could have occurred in 12 % of assessments. Conclusions: Next to systematic application of clinical guidelines and prescribing via CPOE, order review by a clinical pharmacist is still required to effectively reduce MEs and thus to prevent minor and major adverse drug events with the aim to enhance medication safety.

Elderly patients are vulnerable to adverse drug reactions (ADRs). Drug-related readmissions (DRRs) can be a major consequence of ADR. Therefore, this study aimed to investigate the effects of a ward-based, comprehensive pharmaceutical care service on the occurrence of DRRs as the endpoint in dependent-living elderly patients. A randomized, controlled trial was performed at a German University Hospital. Patients fulfilling the following criteria were eligible: admission to a cooperating ward, existing drug therapy at admission, 65 years of age and older, home-care or nursing home residents in ambulatory care, and a minimum hospital stay of three days. Patients received either standard care (control group) or pharmaceutical care (intervention group). Follow-up consultations were conducted for each patient at 1, 8, 26, and 52 weeks after discharge. The time to DRR was defined as the primary outcome measure and was analysed using the log-rank test. The Cox-proportional hazard model was used for risk factor analysis. Sixty patients (n = 31 intervention group, n = 29 control group) participated in the study. For patients in the intervention group, the median time to DRR was prolonged; however, the level of statistical significance was not reached (log-rank test P = 0.068; HR = 3.28, P = 0.086). When the risk factors ‘age’ or ‘length of stay on the ward’ were added to the Cox proportional hazard model, patients in the control group exhibited a significantly higher risk of experiencing a DRR than patients of the intervention group (HR = 4.62; P = 0.028 including age and HR = 5.76; P = 0.033 including length of stay on the ward). Our findings demonstrate the successful implementation of ward-based, comprehensive pharmaceutical care for dependent-living elderly. Despite a low participation rate, which led to an underpowered study, the results provide a preliminary efficacy signal and effect size estimates to power a definitive trial. Clinicaltrials.gov identifier: NCT01578525 , prospectively registered April 13, 2012.

Background/Objectives: Pharmacovigilance aims to identify, assess, and minimize drug risks, with spontaneous reporting playing a central role. However, the high level of underreporting and the varying data quality are limitations that should be minimized through prospective cohort studies. Methods: Spontaneous reports reported to the Drug Commission of the German Medical Association (AkdÄ) over one year were compared with the adverse drug reaction (ADR) cases systematically recorded in hospital emergency departments. The frequencies of the demographic patient characteristics and the odds ratios, as the relationship between suspected and concomitant medication, were calculated. Results: In the spontaneous reports, cases were reported by patients a median of 12 years younger, and the group of older patients was less represented (10.8% versus 27.3% in the prospective cohort study). Within the study, cases with polypharmacy were documented significantly more often (a median of seven drugs [IQR 3;10] versus a median of two drugs [IQR 1;5] in the spontaneous reports). New drugs and drugs discussed in the media were frequently reported as causing ADRs, whereas drugs with an effect on the central nervous system were more often suspected in the emergency department setting. Conclusions: Both sources for ADRs provide complementary information that improves the detection of risk signals. The aim for the future is to further increase the awareness of spontaneous reports and to answer specific questions with the help of structured investigations. It is important to compare and validate the findings of spontaneous reports and investigations in regular intervals to improve drug safety.

Telepharmacy is used to bridge the persisting shortage of specialist ward-based pharmacists, particularly in intensive care units (ICU). During the coronavirus disease 2019 (COVID-19), pharmacotherapy was rapidly developed, which resulted in multiple changes of guidelines. This potentially led to a differing risk for drug-related problems (DRPs) in ICUs. In this study, DRPs were detected in telepharmacy consultations of a German state-wide telemedicine network for adult patients in rural ICUs. The analysis included ICUs of ten general care hospitals with a total of 514 patients and 1056 consultations. The aim of this retrospective, observational cohort study was to compare and analyze the DRPs resulting from ICU patients with or without COVID-19. Furthermore, known risk groups for severe COVID-19 progression (organ insufficiency [kidney, liver], obesity, sex, and/or older age) were investigated with their non-COVID-19 counterparts. As a result, in both groups patients with acute renal insufficiency and without renal replacement therapy showed a significantly higher risk of being affected by one or more DRPs compared to patients with normal renal function. In COVID-19 patients, the initial recommendation of therapeutic anticoagulation (ATC-code B01AB ‘Heparin group’) resulted in significantly more DRPs compared to non-COVID-19 patients. Therefore, COVID-19 patients with therapeutic anticoagulation and all ICU patients with renal insufficiency should be prioritized for telepharmacy consultations.

Background and Objectives: Neonates and children are at high risk of medication errors (ME) with intravenous (IV) infusion therapies, particularly when strategies such as the “rule of six” with individualized, weight-based concentrations are used. Standard concentrations (SCs) have been proposed to reduce variability, improve safety, and facilitate the use of electronic prescribing and smart infusion technologies. The impact of SCs for continuous IV infusions on ME rates in neonatal and pediatric settings was systematically evaluated. Methods: A systematic review was conducted in MEDLINE, Embase and CINAHL (database inception-August 2025) following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies implementing SCs for neonatal or pediatric IV infusions and measuring outcomes referring to ME rates were included. The relative risk reduction/increase in MEs was calculated. Results: Five uncontrolled before-after studies published between 2005 and 2020 were included. The relative risk reductions ranged from 41.2% to 95.1% for overall ME and from 49.7% to 100% for selected error types. In two studies, the relative risk for two error types (paper-generated prescriptions, administration) increased after implementing SCs. Reviewed benefits included decreased calculation and preparation errors, reduced medication process times, improved workflow efficiency and high staff satisfaction. Conclusions: SCs may contribute to safer IV infusion practice in the neonatal and pediatric setting, especially combined with smart technologies and training. However, current evidence is limited and heterogeneous. Larger, prospective experimental studies are needed to confirm their long-term impact on pediatric ME rates.