Medication errors in cancer therapy: Reports from German hospital pharmacists between 2008 and 2019.

OBJECTIVE: Since medication errors can have severe consequences, the development of methods to improve patient safety is becoming increasingly important. The aim of this evaluation was to identify frequent medication errors in oncology as well as characteristic correlations in the various error patterns. In addition, the implementation rate of the proposed pharmaceutical intervention was determined in order to assess the benefit of a clinical pharmacist in the field of oncology. METHODS: The evaluation was based on a data-set from a national documentation system for medication errors and interventions (DokuPIK) used by hospital pharmacists in the field of oncology from 2008 to 2019, namely 6684 reported cases in oncology, representing about 5% of all reports in DokuPIK. RESULTS: The most frequently reported errors were incorrect doses (22% of reported errors), followed by interactions (14%); in 10% of errors the prescription/documentation was incomplete/incorrect. The intervention suggested by the pharmacist was implemented in 97% of the cases. Based on the respective Anatomical Therapeutical Chemical Classification (ATC codes), drugs (or groups of drugs) were identified that were reported frequently in connection with medication errors, namely carboplatin and cyclophosphamide as anticancer drugs pantoprazole as non-anticancer drug. CONCLUSION: Frequently occurring medication errors in the field of oncology were identified, facilitating the development of specific recommendations for action and prevention strategies. The implementation of an electronic prescription software is particularly recommended for the avoidance of dosage errors in chemotherapy.

Using failure mode and Effects Analysis to increase patient safety in cancer chemotherapy.

BACKGROUND: Medication errors may occur during chemotherapy and can have fatal consequences. Healthcare Failure Mode and Effects Analysis (FMEA) is a method used to detect potential risks and prevent them. OBJECTIVE: Aim of this study was to evaluate the medication process of intravenous tumor therapy in order to guarantee a high standard of patient safety. METHODS: The main part of the study was performed at the University Hospital of Bonn, Germany. After assembling a multidisciplinary team, the individual steps of prescription, compounding, transport, and administration of chemotherapy were mapped in a flow diagram. The possible failures were identified and analyzed by calculating the risk priority numbers (RPNs). Finally, corrective actions were developed and after hypothetical implementation re-analyzed to measure their effects on the process. Subsequently, a shortened FMEA based on the catalogue failure modes developed in Bonn was carried out at the University Hospital of Cologne in order to evaluate its transferability to another hospital. RESULTS: A total of 52 potential failure modes was identified in Bonn. Relating to the RPNs the most critically steps in the process were associated with the prescription, namely, incorrect information about individual parameters of the patient; non-standardized chemotherapy protocols; and problems related to supportive therapy. A significant risk reduction for most of the failure modes was assessed by implementing suitable corrective actions. The shortened FMEA in Cologne led to a different ranking of failure modes. CONCLUSION: The implementation of this analysis has not only identified various safety gaps, but also shows how patient safety during chemotherapy can be enhanced. Moreover, it has sensitized the practitioners to failure modes potentially occurring in their work routine.

Tris(2-aminoethyl)amine-based α-branched fatty acid amides - Synthesis of lipids and comparative study of transfection efficiency of their lipid formulations.

The synthesis of a new class of cationic lipids, tris(2-aminoethyl)amine-based α-branched fatty acid amides, is described resulting in a series of lipids with specific variations in the lipophilic as well as the hydrophilic part of the lipids. In-vitro structure/transfection relationships were established by application of complexes of these lipids with plasmid DNA (pDNA) to different cell lines. The α-branched fatty acid amide bearing two tetradecyl chains and two lysine molecules (T14diLys) in mixture with the co-lipid 1,2-di-[(9Z)-octadec-9-enoyl]-sn-glycero-3-phosphoethanolamine (DOPE) (1/2, n/n) exhibits effective pDNA transfer in three different cell lines, namely Hep-G2, A549, and COS-7. The presence of 10% serum during lipoplex incubation of the cells did not affect the transfection efficiency. Based on that, detailed investigations of the complexation of pDNA with the lipid formulation T14diLys/DOPE 1/2 (n/n) were carried out with respect to particle size and charge using dynamic light scattering (DLS), ζ-potential measurements, and transmission electron microscopy (TEM). Additionally, the lipoplex uptake was investigated by confocal laser scanning microscopy (CLSM). Overall, lipoplexes prepared from T14diLys/DOPE 1/2 (n/n) offer large potential as lipid-based polynucleotide carriers and further justify advanced examinations.

The TransEurope FootRace Project: longitudinal data acquisition in a cluster randomized mobile MRI observational cohort study on 44 endurance runners at a 64-stage 4,486 km transcontinental ultramarathon.

BACKGROUND: The TransEurope FootRace 2009 (TEFR09) was one of the longest transcontinental ultramarathons with an extreme endurance physical load of running nearly 4,500 km in 64 days. The aim of this study was to assess the wide spectrum of adaptive responses in humans regarding the different tissues, organs and functional systems being exposed to such chronic physical endurance load with limited time for regeneration and resulting negative energy balance. A detailed description of the TEFR project and its implemented measuring methods in relation to the hypotheses are presented. METHODS: The most important research tool was a 1.5 Tesla magnetic resonance imaging (MRI) scanner mounted on a mobile unit following the ultra runners from stage to stage each day. Forty-four study volunteers (67% of the participants) were cluster randomized into two groups for MRI measurements (22 subjects each) according to the project protocol with its different research modules: musculoskeletal system, brain and pain perception, cardiovascular system, body composition, and oxidative stress and inflammation. Complementary to the diverse daily mobile MR-measurements on different topics (muscle and joint MRI, T2*-mapping of cartilage, MR-spectroscopy of muscles, functional MRI of the brain, cardiac and vascular cine MRI, whole body MRI) other methods were also used: ice-water pain test, psychometric questionnaires, bioelectrical impedance analysis (BIA), skinfold thickness and limb circumference measurements, daily urine samples, periodic blood samples and electrocardiograms (ECG). RESULTS: Thirty volunteers (68%) reached the finish line at North Cape. The mean total race speed was 8.35 km/hour. Finishers invested 552 hours in total. The completion rate for planned MRI investigations was more than 95%: 741 MR-examinations with 2,637 MRI sequences (more than 200,000 picture data), 5,720 urine samples, 244 blood samples, 205 ECG, 1,018 BIA, 539 anthropological measurements and 150 psychological questionnaires. CONCLUSIONS: This study demonstrates the feasibility of conducting a trial based centrally on mobile MR-measurements which were performed during ten weeks while crossing an entire continent. This article is the reference for contemporary result reports on the different scientific topics of the TEFR project, which may reveal additional new knowledge on the physiological and pathological processes of the functional systems on the organ, cellular and sub-cellular level at the limits of stress and strain of the human body. Please see related articles: http://www.biomedcentral.com/1741-7015/10/76 and http://www.biomedcentral.com/1741-7015/10/77.

Anthropometry and pre-race experience of finishers and nonfinishers in a multistage ultra-endurance run--Deutschlandlauf 2007.

The effects of anthropometry and pre-race experience on race performance were investigated in male nonprofessional ultra-runners performing a multistage run of 1,200 km over 17 days. Of 24 athletes examined pre-race, 14 (58%) dropped out during the race due to overuse injuries of the lower limbs. During the race, body mass, thickness of the calf skin-fold, skeletal muscle mass, and percent body fat decreased significantly, while circumference of the upper arm, thickness of triceps, and abdominal skin-fold as well as Body Mass Index decreased significantly in the finishers. Neither anthropometry nor pre-race experience and training volume nor previously finished races were associated with the race time of the finishers. In future studies of ultra-runners, the influence of psychological (cognitive and emotional) predictors on race outcome should be investigated.

Physical-chemical properties and transfection activity of cationic lipid/DNA complexes.

Investigation of DNA interactions with cationic lipids is of particular importance for the fabrication of biosensors and nanodevices. Furthermore, lipid/DNA complexes can be applied for direct delivery of DNA-based biopharmaceuticals to damaged cells as non-viral vectors. To obtain more effective and safer DNA vectors, the new cationic lipids 2-tetradecylhexadecanoic acid-{2-[(2-aminoethyl)amino]ethyl}amide (CI) and 2-tetradecylhexadecanoic acid-2-[bis(2-aminoethyl)amino]ethylamide (CII) were synthesized and characterized. The synthesis, physical-chemical properties and first transfection and toxicity experiments are reported. Special attention was focused on the capability of CI and CII to complex DNA at low and high subphase pH values. Langmuir monolayers at the air/water interface represent a well-defined model system to study the lipid/DNA complexes. Interactions and ordering of DNA under Langmuir monolayers of the new cationic lipids were studied using film balance measurements, grazing incidence X-ray diffraction (GIXD) and X-ray reflectivity (XR). The results obtained demonstrate the ability of these cationic lipids to couple with DNA at low as well as at high pH value. Moreover, the observed DNA structuring seems not to depend on subphase pH conditions. An influence of the chemical structure of the lipid head group on the DNA binding ability was clearly observed. Both compounds show good transfection efficacy and low toxicity in the in vitro experiments indicating that lipids with such structures are promising candidates for successful gene delivery systems.

The effects of running 1,200 km within 17 days on body composition in a female ultrarunner-Deutschlandlauf 2007.

We describe the changes of body composition in the female overall winner of the Deutschlandlauf 2007 over 17 stages from the northeast to the southwest of Germany with average daily running stages of 70.9 km to cover the total distance of 1,200 km. Determined by bioelectrical impedance analysis, body mass (BM) increased, percent body fat (% BF) decreased, and percent body water as well as lean body mass (LBM) increased. Skeletal muscle mass and % BF as determined by an anthropometric method showed no changes. This data show, that this female runner achieved an excellent performance and that it is possible for a woman to beat all the men. This type of analysis provides a unique opportunity to gain insight into the physiological changes during multiday running in ultraendurance athletes.

Vitamins, minerals and race performance in ultra-endurance runners--Deutschlandlauf 2006.

We investigated the effect of pre-race intake of vitamins and minerals, in the form of supplementation, before a multi-stage ultra-endurance run and their effect on race performance. At the Deutschlandlauf 2006 in Germany, where athletes had to run across Germany from the north (Kap Arkona-Rügen) to the south (Lörrach) over 1,200 km within 17 consecutive stages, twenty male ultra runners (46.2+/-9.6 years, 71.8+/-5.2 kg, 179+/-6 cm, BMI 22.5+/-1.9 kg/m2) completed a questionnaire about their intake of vitamin and mineral supplements in the four weeks before the race. Race performance of athletes with- and athletes without regular intake of these supplements were compared. In the four weeks before the run, nine runners (45%) ingested vitamin- and twelve athletes (60%) mineral supplements. Athletes with an intake of vitamins (152.8+/-14.1 h versus 160.6+/-14.6 h, p>0.05) and minerals (151.6+/-14.5 h versus 165.3+/-10.8 h, p>0.05) finished the race no faster than athletes without an intake of vitamins and minerals. We concluded that in the Deutschlandlauf 2006 of over 1,200 km within 17 consecutive stages, athletes with a regular intake of vitamin and mineral supplements in the four weeks before the race finished the competition no faster than athletes without an intake of vitamins and minerals.

A Multi-Stage Ultra-Endurance Run over 1,200 KM Leads to a Continuous Accumulation of Total Body Water.

We determined whether ultra-runners in a multi-stage ultra- endurance run lose body mass, fat mass, skeletal muscle mass or total body water in a descriptive field study at the 'Deutschlandlauf' 2007 a 1,200 km run within 17 consecutive days with 10 male non-professional Caucasian ultra-runners (mean ± SD, 43.8 ± 6.2 years, 73.8 ± 6.0 kg body mass, 1.77 ± 0.05 m body height, BMI 23.3 ± 1.8 kg·m(-2)). Body mass, fat mass, skeletal muscle mass, lean body mass and percent total body water were determined using bioelectrical impedance analysis and the anthropometric method before the race and after each stage. In addition, urinary specific gravity was measured in order to quantify hydration status. Fat mass (bioelectrical impedance analysis) decreased by 3.9 kg (p < 0.05), skeletal muscle mass (anthropometric method) decreased by 2.0 kg (p < 0.05) whereas percent total body water increased by 6.1 % (p < 0.05) by the end of the race. Ultra-runners in a multi-stage ultra-endurance event over 1,200 km, with 17 consecutive stages, showed a cumulative increase in percent total body water, a decrease in skeletal muscle mass and a decrease in fat mass, depending upon the method used. We presume that the eccentric component of running leads to damage of skeletal muscle, leading to rhabdomyolysis, with impaired renal function. Key pointsUltra-runners in a multi-stage ultra-endurance run over 1,200 km in 17 consecutive stages suffered a decrease in fat mass, skeletal muscle mass and an increase in total body water, whereas overall body mass showed no change.

Physicochemical investigation of a lipid with a new core structure for gene transfection: 2-amino-3-hexadecyloxy-2-(hexadecyloxymethyl)propan-1-ol.

Cationic liposomes/DNA complexes can be used as nonviral vectors for direct delivery of DNA-based biopharmaceuticals to damaged cells and tissues. In order to obtain more effective and safer liposome-based gene transfection systems, the new cationic lipid 2-amino-3-hexadecyloxy-2-(hexadecyloxymethyl)propan-1-ol (AHHP) was synthesized. In this paper we report on the synthesis of AHHP and investigations of its physical-chemical properties. Langmuir monolayers of AHHP were studied at the air/buffer interface by film balance measurements, grazing incidence X-ray diffraction (GIXD), and infrared reflection absorption spectroscopy (IRRAS). Structure and thermotropic phase behavior of AHHP in aqueous dispersion were examined by small-angle and wide-angle X-ray scattering (SAXS/WAXS) and differential scanning calorimetry (DSC). The results show clear differences in structure and phase behavior of AHHP, both in the monolayer system and in aqueous dispersions, in dependence on the subphase pH due to protonation or deprotonation of the primary amine in the lipid head group. Thermodynamic data derived from pi-A isotherms provide information about the critical temperature (Tc), which is in rough agreement with the temperature of the lipid phase transition from gel to fluid state (Tm) found by X-ray and calorimetry studies of AHHP aqueous dispersions. The packing properties of the molecules in mono- and bilayer systems are very similar. DNA couples to the monolayer of the new lipid at low as well as at high pH but in different amounts. The DNA coupling leads to an alignment of adsorbed DNA strands indicated by the appearance of a Bragg peak. The distance between aligned DNA strands does not change much with increasing monolayer pressure.