Yvonne Remane

Background: Vancomycin therapy is challenging in hematology patients due to their complex therapies, frequent infections, variable renal function, and nephrotoxic co-medications, resulting in high pharmacokinetic variability. Methods: Vancomycin therapy was retrospectively analyzed over three consecutive periods using routine clinical data from a German tertiary academic hematology ward, focusing on recommended loading dose administration, therapeutic trough concentration attainment (15–20 mg/L), and a potential acute kidney injury (AKI): (I) baseline cohort (BC)—usual care; (IIa) infectious diseases support cohort (IDSC)—following collaboration with infectiologists; and (IIb) infectious diseases and pharmacy support cohort (IDPSC)—following additional clinical pharmacist involvement. Results: Overall, 155 patients receiving 164 vancomycin cycles were included. Recommended loading dose adherence increased from 3.3% (n = 3/90) in the BC to 32.6% (n = 15/46) in the IDSC and 53.6% (n = 15/28) in the IDPSC. The difference was statistically significant for both IDSC and IDPSC vs. BC (χ² test, p < 0.001). Across cohorts, therapeutic trough concentrations were attained faster with the recommended than with an inadequate loading dose (median 4 vs. 8 days; log-rank test, p = 0.001). Subtherapeutic trough levels decreased (BC 78.6% vs. IDSC 65.5% vs. IDPSC 46.4%), while supratherapeutic levels increased (BC 7.6% vs. IDSC 10.8% vs. IDPSC 23.2%), accompanied by a higher AKI incidence (BC 20.0% vs. IDSC 17.4% vs. IDPSC 39.3%). The difference in AKI was statistically significant for IDPSC vs. BC (χ² test, p = 0.038) and IDSC (χ² test, p = 0.037). Conclusions: A recommended vancomycin loading dose within the interprofessional care cohort achieves therapeutic trough concentrations faster but requires close monitoring for nephrotoxicity.

Objective: Pharmacoeconomic evaluation of clinical pharmacy services (CPS) aims to assess the contribution of clinical pharmacists (CP) to optimize the medication process by interventions while simultaneously saving costs. The objective of this study was to provide a valuable contribution by calculating the pharmacoeconomic benefit per full-time equivalent (FTE) comparing costs of avoided adverse drug events (ADE) with CP wage costs in a German tertiary care centre. Methods: CPs recorded their interventions according to an internal documentation tool, and an expert panel evaluated the likelihood that these interventions would have averted an ADE. The internal cost-avoidance analysis involved determining the total amount of ADE excess costs that could potentially be avoided in 2021. This was achieved by multiplying the median probability of an ADE occurring, as evaluated by an expert panel, by the inflation-adjusted ADE excess costs. These factors, in combination with CP wage costs contributed to the calculation of the pharmacoeconomic benefit. FTEs were used to improve comparability. Deterministic sensitivity analysis was conducted for relevant parameters. Results: Some 221 out of 3,562 recorded active interventions were analysed. The major interventions made by CPs were medication stops or dosage changes, representing more than 50% of all CPS provided in 2021. To sum up, the findings demonstrated that interventions preventing ADEs are beneficial. A pharmacoeconomic benefit of €13,467 per FTE was calculated. The sensitivity analysis revealed further savings potential, as our model was based on rather conservative assumptions. Conclusion: This study has demonstrated pharmacoeconomic benefits of CP interventions. The necessity of integrating CPs into routine care to improve patient care quality while increasing economic efficiency has been proven. Future studies should investigate the long-term effects of these interventions and their implementation in other healthcare facilities to determine the full potential of CPs.

Background: Intravenous anti-infectives are an important part of postoperative care, but discrepancies between prescribed and documented administrations remain widespread and require systematic evaluation. Methods: In an exploratory study, prescribed and documented intravenous anti-infective administrations were retrospectively analyzed using patient charts, digital nursing reports and, in cases of deviations, consultations with the responsible staff. The discrepancies were classified into three categories: (I) documentation, (II) administration, and (III) a combination of both. The relationship between discrepancies and dosing interval, time of administration (weekday and shift assignment), and intravenous administration route was statistically analyzed (Χ² test, residual analysis). Results: Of 5016 anti-infective administrations in 219 patients, 1135 (22.6%) had at least one discrepancy, of which 68.2% (774 of 1135) belonged to category I. Significant differences in the frequency of discrepancies between surgical wards and the dosing intervals were observed. On weekdays, 23.6% of drug administrations (832 of 3519) showed discrepancies compared to 20.2% on weekends (303 of 1497, OR = 1.22, 95% CI 1.05–1.42, p = 0.008). Although the early shift had the lowest administration rate, it showed significantly more discrepancies than expected (313.6 expected vs. 553 observed; adjusted standardized residual +18.1; p < 0.001). Drug administration via the peripheral venous route was more susceptible to discrepancies than the central venous administration route (23.2% [963 of 4149] vs. 19.8% [172 of 867]), OR 1.18; 95% CI 1.01–1.38; p = 0.031). Conclusions: Approximately a quarter of anti-infective administrations were affected by discrepancies, predominantly in category I, with the highest incidences occurring during the early shift and on weekdays. This requires a multi-step improvement program.

Background: Patients presenting at the emergency department (ED) have a wide variety of complaints. In some of those patients a possible reason for their complaints might be an adverse drug reaction (ADR). An appropriate identification of ADR in this setting is required to optimize drug therapy and to prevent serious harm deriving from an overlooked ADR. Methods: This retrospective study assessed medical records of patients for ADR as a reason for the ED presentation in two assessments. In the first assessment, medical records were evaluated for potential ADR leading to ED presentation with a predefined checklist by an examiner not involved in initial patient treatment. In the second assessment the same medical records were assessed for ADR identified by the physician in the initial patient presentation. Discrepancies in identified ADR were compared. For descriptive data analysis and statistical evaluation, the McNemar test was performed. Results: From 35,333 patients admitted to the ED, full data were available from 34,747 patients for evaluation. In those patients, 2071 (6.0%) ADR were identified as being the reason for ED presentation by using the checklist. In 828 (2.4%) patients, emergency department physicians had documented an ADR in the medical records. By using the checklist, ADR identification could be improved significantly as compared to routine care, at 6.0% vs. 2.4%, respectively (p < 0.001). The most common chief complaint in patients with an ADR was worsened general condition. Most common drug class causing ADR were antithrombotics. Conclusions: ADR seem to be overlooked in routine care since a significantly higher number of ADR were found by using a checklist-based method as compared to ADR documented as part of routine examination. Therefore, implementing the checklist in the routine process might improve ADR identification.

Background Intravenous drug administration is essential in intensive care treatment. However, the risk of particulate contamination in infusion solutions during treatment is often underestimated. Methods Residual amounts of infusion solutions prepared and administered at the adult intensive care unit were examined for visible and subvisible particles according to the recommendations of the European Pharmacopoeia monographs 2.9.19 and 2.9.20. Results Samples from 169 infusion solutions were collected, 149 of which could be analysed. The Pharmacopoeia requirements for visible particles were not fulfilled in 42.9% (n=64/149) of the samples, while the requirements for subvisible particles were not met in 4.7% (n=7/149). A specific correlation between the pharmaceutical drugs or within the infusion set (bottle vs connected infusion line) and particulate contamination was not possible as the sample was too small for a correlation analysis. A Spearman rho analysis showed no correlation between particle contamination and administration mode (subvisible (10 µm): p=0.969, r=−0.005; subvisible (25 µm): p=0.834, r=−0.026; visible: p=0.711, r=−0.047) and particle contamination and dosage form (subvisible (10 µm): p=0.291, r=−0.092; subvisible (25 µm): p=0.513, r=0.057; visible: p=0.415, r=0.071). Conclusions This study showed that residuals of intravenously administered solutions have particulate contaminations. A specific causal factor was not identified.

Transplant patients are at an elevated risk for infections. Therefore, infection prevention plays a pivotal role in their care. Two different approaches were chosen to determine their vaccination status and motivation. The vaccination rate was determined by analyzing the patients’ vaccination cards based on German vaccination recommendations. The vaccinations were categorized into standard, indicated, and risk-dependent vaccinations. The vaccination motivation was determined through a semi-structured interview using a self-developed questionnaire as an interview guide. Both parts were analyzed separately. A total of 126 patients were included in the study. In 115 (91.3%) patients, vaccination cards were available, 64.3% had complete standard and 0.9% indicated vaccinations. In the risk-dependent vaccinations category, 49.6% of participants had at least one of the additional vaccinations. The vaccination rate against hepatitis B was significantly higher in kidney than in liver transplant recipients (88.1% vs. 55.4%, Χ2 = 13.7, p < 0.001, n = 107). Vaccination confidence correlated significantly with willingness to vaccinate (r = 0.362, p < 0.001, n = 123). In conclusion, only a few transplant patients have complete vaccination protection. Further patient education is needed to increase patients’ confidence in vaccinations and to motivate them.

Background/Objectives: In older patients, falls constitute a significant public health concern and a major cause of hospital admission. Fall-risk-increasing drugs (FRIDs) represent a key risk factor for falls. Therefore, modifying these drugs represents an important strategy for preventing recurrent falls and further patient harm. The objective of this study was to evaluate a structured interprofessional collaboration between physicians and pharmacists on managing FRIDs in older patients who present to the emergency department (ED) after a fall. Methods: This study was performed in the ED of a tertiary care hospital. Patients who were >65 years old and presented to the ED after a fall were included. A routine care group was included between 1 March 2020 and 31 May 2020. A pharmaceutical care group was included between 1 September 2023 and 30 November 2023. In the pharmaceutical care group, a clinical pharmacist supported the physicians in identifying and managing FRIDs. Possible solutions for improving FRID prescription were discussed interprofessionally. The number of FRIDs at ED admission and discharge, as well as the number of FRID modifications, were evaluated. Results: A total of 107 patients were enrolled in each group. There were 85 patients in the routine care group and 89 patients in the pharmaceutical care group, with at least 1 FRID prescribed at ED admission (p = 0.483). At ED discharge, there were 85 patients in the routine care group and 68 patients in the pharmaceutical care group, with at least 1 FRID prescribed at (p = 0.010). There were seven FRID modifications in the routine care group compared to 125 FRID modifications in the pharmaceutical care group. Conclusions: In this study, the interprofessional collaboration between physicians and pharmacists led to a reduced number of FRIDs being prescribed and more FRID modifications in older patients at ED discharge. Further research is required to ascertain the feasibility of integrating this single intervention into a multifactorial fall prevention program.

Complete medication reconciliation during hospital admission is the rationale for further treatment decisions. A consecutive, controlled intervention study was conducted to assess discrepancies in medication reconciliation performed by nurses of the Urology Department compared to the Best Possible Medication History (BPMH) established by pharmacists. This study included pre-intervention (control group, CG), nursing training as a pharmaceutical intervention, and post-intervention (intervention group, IG) groups. The discrepancies were classified as “Missing” (not recorded but taken), “Added” (additionally recorded) “Strength” (incorrect documented dosage), “Intake” (incorrect intake time/schedule), “Double” (double prescription), and “Others” (no clear assignment). Additionally, high-risk drug subgroup discrepancies were particularly prevalent and were evaluated. Training success was compared concerning discrepancies in the CG and IG. Generally, the percentage of discrepancies per patient found was lower in the IG than in the CG (78.1% vs. 87.5%, significantly). The category most identified was “Missing” (IG, 33.3% vs. CG, 35.2%). Overall, a discrepancy of 7.4% each (discrepancies: IG, 27 vs. CG, 38) was determined for high-risk drugs while “Missing” occurred (77.8% vs. 52.6%, out of 7.4%). Despite nursing training only partially reducing discrepancies, the implementation of medication reconciliation using BPMH by pharmacists could improve the process, especially for high-risk drugs.

Understanding SARS-CoV-2 breakthrough infections in vaccinated healthcare workers is of key importance in mitigating the effects of the COVID-19 pandemic in healthcare facilities. An observational prospective cohort study was conducted in vaccinated employees with acute SARS-CoV-2 infection between October 2021 and February 2022. Serological and molecular testing was performed to determine SARS-CoV-2 viral load, lineage, antibody levels, and neutralizing antibody titers. A total of 571 (9.7%) employees experienced SARS-CoV-2 breakthrough infections during the enrolment period, of which 81 were included. The majority (n = 79, 97.5%) were symptomatic and most (n = 75, 92.6%) showed Ct values < 30 in RT-PCR assays. Twenty-four (30%) remained PCR-positive for > 15 days. Neutralizing antibody titers were strongest for the wildtype, intermediate for Delta, and lowest for Omicron variants. Omicron infections occurred at higher anti-RBD-IgG serum levels (p = 0.00001) and showed a trend for higher viral loads (p = 0.14, median Ct difference 4.3, 95% CI [−2.5–10.5]). For both variants, viral loads were significantly higher in participants with lower anti-RBD-IgG serum levels (p = 0.02). In conclusion, while the clinical course of infection with both the Omicron and Delta variants was predominantly mild to moderate in our study population, waning immune response over time and prolonged viral shedding were observed.