European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Oct 2020
Randomized Controlled Trial Multicenter StudyPatient safety incidents and medication errors during a clinical trial: experience from a pre-hospital randomized controlled trial of emergency medication administration.
To assess and evaluate patient safety incidents and in particular, medication errors, during a large multi-center pre-hospital trial of emergency therapy (PARAMEDIC2), in order to inform and improve future pre-hospital medicines trials. ⋯ Eight thousand sixteen patients were enrolled, of whom 4902 received trial medication. A total of 331 patient safety incidents was reported, involving 295 patients, representing an overall rate of 3.6% of these, 166 (50.2%) were documentation errors while 165 (49.8%) were clinical protocol/medication errors. An overall rate of 0-4.5% was reported across all five ambulance services, with a mean of 2.0%. These errors had no impact on patient care or the trial and were all resolved CONCLUSION: The overall medication error rate of 1.8% primarily consisted of administration of open-label adrenaline and confusion with trial medication packs. A similar number of patients had documentation errors. This study is the first to provide data on patient safety incidents relating to medication errors encountered during a pre-hospital trial of emergency medication administration and will provide supporting data for planning future trials in this area.
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Eur. J. Clin. Pharmacol. · Mar 2018
Multicenter Study Observational StudyEffectiveness of biosimilar filgrastim vs. original granulocyte colony-stimulating factors in febrile neutropenia prevention in breast cancer patients.
The purpose of this study is to describe the effectiveness of biosimilar filgrastim and original granulocyte colony-stimulating factors (G-CSFs), lenograstim and pegfilgrastim, in febrile neutropenia (FN) prevention in breast cancer patients receiving docetaxel/doxorubicin/cyclophosphamide (TAC) as adjuvant/neoadjuvant treatment and to analyze their treatment patterns. ⋯ An abbreviated 5-day course of biosimilar filgrastim provided optimal primary prophylaxis against FN post-chemotherapy TAC in patients with breast cancer. The clinical relevance of the highest FN incidence in the lenograstim cohort needs further attention.
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Eur. J. Clin. Pharmacol. · Aug 2016
Multicenter StudyPro re nata (as needed) medication in nursing homes: the longer you stay, the more you get?
Injudicious pro re nata (PRN) or as needed prescribing can lead to polypharmacy, potentially harmful drug interactions and total drug doses exceeding the maximum recommended. Despite the known risks and the widespread administration, there is a paucity of current research examining the use of PRN drugs in nursing homes. Therefore, we examined characteristics of PRN drug use and potential predictors in nursing homes. ⋯ The high prevalence of PRN medication should be taken into account when considering polypharmacy and inappropriate drug prescribing or using screening tools like the STOPP/START (screening tool of older persons' potentially inappropriate prescriptions/screening tool to alert doctors to right) criteria in nursing homes. Physicians should regularly reconsider the need of each PRN drug on the medication schedule. Moreover, the high prevalence of PRN medication and the association with length of stay highlights the importance of an accurate documentation.
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Eur. J. Clin. Pharmacol. · Jan 2016
Multicenter StudyOff-label and unlicensed drug treatments in Neonatal Intensive Care Units: an Italian multicentre study.
The use of medicines among newborns admitted to intensive care units is characterized by a high prevalence of off-label/unlicensed use and a wide variability in the absence of international guidelines. A prospective cross-sectional study was organized with the aim to analyse drug prescriptions among all 107 Italian level III neonatal intensive care units. ⋯ Our results confirm the high prevalence of off-label/unlicensed drug use in the neonatal population and underline a better adherence to indications based on clinical practice, suggesting the need to update information contained in the data sheets of medicines.
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Eur. J. Clin. Pharmacol. · Jul 2015
Multicenter StudyThe EU(7)-PIM list: a list of potentially inappropriate medications for older people consented by experts from seven European countries.
The aim of the study was to develop a European list of potentially inappropriate medications (PIM) for older people, which can be used for the analysis and comparison of prescribing patterns across European countries and for clinical practice. ⋯ The European Union (EU)(7)-PIM list is a screening tool, developed with participation of experts from seven European countries, that allows identification and comparison of PIM prescribing patterns for older people across European countries. It can also be used as a guide in clinical practice, although it does not substitute the decision-making process of individualised prescribing for older people. Further research is needed to investigate the feasibility and applicability and, finally, the clinical benefits of the newly developed list.