EurOP²E – the European Open Platform for Prescribing Education, a consensus study among clinical pharmacology and therapeutics teachers

Purpose Sharing and developing digital educational resources and open educational resources has been proposed as a way to harmonize and improve clinical pharmacology and therapeutics (CPT) education in European medical schools. Previous research, however, has shown that there are barriers to the adoption and implementation of open educational resources. The aim of this study was to determine perceived opportunities and barriers to the use and creation of open educational resources among European CPT teachers and possible solutions for these barriers. Methods CPT teachers of British and EU medical schools completed an online survey. Opportunities and challenges were identified by thematic analyses and subsequently discussed in an international consensus meeting. Results Data from 99 CPT teachers from 95 medical schools were analysed. Thirty teachers (30.3%) shared or collaboratively produced digital educational resources. All teachers foresaw opportunities in the more active use of open educational resources, including improving the quality of their teaching. The challenges reported were language barriers, local differences, lack of time, technological issues, difficulties with quality management, and copyright restrictions. Practical solutions for these challenges were discussed and include a peer review system, clear indexing, and use of copyright licenses that permit adaptation of resources. Conclusion Key challenges to making greater use of CPT open educational resources are a limited applicability of such resources due to language and local differences and quality concerns. These challenges may be resolved by relatively simple measures, such as allowing adaptation and translation of resources and a peer review system

Cell and Gene Therapies: European View on Challenges in Translation and How to Address Them

Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A significant proportion of the products are being developed by academia or small/medium-sized enterprises (SMEs). The many challenges in translation posed by this class of products include aspects covering: manufacturing, non-clinical development plan as relevant to clinical trial, marketing authorization, and reimbursement. In this context, the term translation refers to the relevance of non-clinical data in relation to how it impacts on appropriate and efficient clinical development. In order to successfully overcome these challenges, a clear understanding of the requirements and expectations of all the stakeholders is critical. This article aims to cover the potential challenges related to such translation and suggested approaches to find solutions based on experience and learnings from the perspective of European Union. While commercial challenges have a significant impact on the ATMPs in general, it is considered outside the scope of this article. However, by adopting a strong scientific basis for translation as suggested in this article, it is likely such an approach would help rather than harm successful real world clinical use of ATMPs

Skeletal Muscle-Derived Stem Cells: Implications for Cell-Mediated Therapies

Current advances in stem cell research and innovative biological approaches in the field of tissue engineering and regenerative medicine could eventually translate into prospective clinical applications. Various adult organs and tissues harbor stem and progenitor cells that could potentially be used to repair, regenerate, and restore a variety of different tissues following acute injury or tissue destructive diseases. Skeletal muscle is a very convenient and plentiful source of somatic stem cells. It contains several distinct populations of myogenic stem cells including satellite cells that are mainly responsible for muscle growth and regeneration, and multipotent muscle-derived stem cells (MDSCs). Although both cell populations share some phenotypic similarities, MDSCs display a much greater differentiation potential in vitro and are capable of regenerating various tissues in vivo. Furthermore, these cells not only participate in the regeneration process by differentiating into tissue-specific cell types, but also promote endogenous tissue repair by secreting a multitude of trophic factors. In this article, we describe the biological aspects of MDSC isolation and characterization and provide an overview of potential therapeutic application of these cells for the treatment of cardiac and skeletal muscle injuries and diseases, urological dysfunction, and bone and cartilage defects. We also discuss major challenges and limitations currently faced by MDSC-based therapies that await resolution before these techniques can be applied clinically

Evaluation of needs for therapeutic monitoring of digoxin in a tertiary hospital

Objectives. To collect the data about the consumption of digoxin, evaluate the tendencies towards usage of this drug during 2004–2007, and to find departments, which cover the main part of digoxin consumption in a tertiary hospital. To evaluate the intensity of serum digoxin concentration measurements during 2005–2007. Material and methods. Our study was carried out in a tertiary hospital with 2600 beds and 63 departments. Consumption of digoxin is expressed in defined daily doses per 100 occupied beds daily during 2004–2007. All serum concentration measurements in 2005–2007 were evaluated. Results. The main consumers of digoxin in 2007 were the Units of Endocrinology, Pulmonology and Immunology, Cardiology II, Neurosurgical Reanimation and Intensive Care, Neurology, Eye Disorders I, Intensive Care Unit of Cardiology; they consumed 51.05% of total digoxin. In total, 58 digoxin measurements were performed in 2005, 89 in 2006, and 64 in 2007. The intensity of serum concentration measurements for digoxin is 1/147 (one measurement for 147 defined daily doses) in 2005, 1/89 in 2006, and 1/107 in 2007. These results show that intensity of serum digoxin concentration measurements is low. Conclusions. Twenty-two out of the 63 departments cover 90% of digoxin consumption per year. The changes in digoxin consumption were not statistically significantly different in 2004– 2007. There was a tendency towards an increase in serum digoxin concentration measurements during the 3-year period. Digoxin concentration outside therapeutic ranges was established in about half of all cases in 2005–2006, but there was an increase in normal serum concentration in 2007

Rationality of Administered Gentamicin Dose in Cerebral Coma Patients Treated in an Intensive Care Unit

Gentamicin is still widely used in the treatment of patients in an intensive care unit (ICU). The efficacy of aminoglycosides correlates with the peak serum concentration (Cmax), and the toxicity with the minimum serum concentration (Cmin). The aim of this study was to determine Cmax and Cmin in serum of cerebral coma ICU patients when a dosage of gentamicin of 5 mg/kg body weight was administered once daily; to evaluate the rationality of mentioned dose; and to identify factors associated with these concentrations. Material and Methods. A total of 24 ICU patients suffering from cerebral coma were included into this analysis. A dosage of gentamicin of 5 mg/kg body weight was administered once a day. Gentamicin concentrations were tested twice after the first dose infusion (immediately and 5 hours after 1-hour infusion). Cmax, Cmin, volume of distribution (Vd), and elimination half-life (T1/2) were obtained. Results. The mean Cmax was 17.96 (SD, 4.31) μg/mL (range, 10.30–27.87 μg/mL). The desirable Cmax (≥20 μg/mL) was reached only in 6 patients (25%). Cmin was calculated using a special pharmacokinetic program “Kinetica.” Cmin of 0.5 μg/mL was not exceeded in any patient. A correlative analysis indicated a significant inverse direct correlation between Cmax and Vd and between Cmax and treatment duration in the ICU. An inverse correlation was observed between Cmin and T1/2, evaluation of coma according to the Glasgow coma scale, and creatinine clearance. Conclusions. A dosage of 5 mg/kg body weight once a day was not sufficient in cerebral coma ICU patients. This dose was not associated with the nephrotoxic effect of gentamicin (additional risk factors were absent). It is recommended to obtain gentamicin concentration at two time points following administration of the first dose (e.g., immediately after 1-hour infusion and 5 hours later), and using a special pharmacokinetic software, to calculate a necessary dose and interval of administration

Breastfeeding and medications

Breastfeeding is the most healthful method of feeding neonates and infants. In 2001 about 98% of new mothers in Lithuania started breastfeeding their neonates. One-third of nursing women (34%) discontinued breastfeeding at the time when infant reached the age of 3 months. About 56% of women breastfed their infants longer than 4 months. Only 3–6% of nursing women discontinued breastfeeding after the fourth month. Discontinuation of breastfeeding in 21–23% of all cases was directly or indirectly associated with use of medications. Such data suggest that there is a lack of information often leading physicians to advise mothers to discontinue breastfeeding because of medication use. The aim of this article was to survey the situation about classification of drugs used during breastfeeding and factors influencing drug transfer into milk in order to give more information for physician concerning the use of medication during breastfeeding. In this review, a short description of main pharmacokinetic characteristics, influencing drug transfer into milk; information on the classification of drugs used during breastfeeding; some considerations on drug safety and possible adverse effects of medications on breastfed infant; the list of drugs preferred for nursing women are presented

Compliance in psychiatry: results of a survey of depressed patients using orally disintegrating tablet

As many as 60% of the patients do not follow the therapy recommended by their physicians. An important factor that can influence patient’s compliance is the physician’s opinion about the tolerability and safety of prescribed medication. However, the efforts of both parties, not only physician but also patient, have benefits on the outcome of treatment. Patient’s opinion on choosing the form of medication is appropriate way ensuring better compliance. The aim of the survey was to ascertain the opinion of depressed patients towards a new formulation of antidepressant drug, mirtazapine – orally disintegrating tablet Remeron SolTab. The study was approved by Lithuanian State Medicines Control Agency and local Ethics Committee. A total of 453 depressed patients were included in the survey. Most of the patients used a 30-mg dose of Remeron SolTab (n=344, 75.88%). Most of the patients (n=189, 41.81%) had a positive opinion about the taste of medication (“very pleasant”). According to the results of the survey, 281 (61.95%) used Remeron SolTab regularly. However, 129 (28.54%) patients noted that the new drug formulation had no influence on the regularity of use. Statistically significantly more patients (81.86%) noted that they would choose Remeron SolTab compared to the patients who would prefer conventional form of the medication (2.21%). In 184 (40.71%) patients, a significant mood improvement was noted. Most of the patients (n=246, 54.20%) indicated that mood improved. Based on the results of the survey it can be concluded that patient will prefer the drug (or its new formulation) he/she liked and thus will follow physician’s instructions and cooperate with physician more closely..

Cerebrinę komą patyrusiems intensyviosios terapijos pacientams skiriamos gentamicino dozės racionalumo tyrimas

Gentamicin is still widely used in the treatment of patients in an intensive care unit (ICU). The efficacy of aminoglycosides correlates with the peak serum concentration (Cmax), and the toxicity with the minimum serum concentration (Cmin). The aim of this study was to determine Cmax and Cmin in serum of cerebral coma ICU patients when a dosage of gentamicin of 5 mg/kg body weight was administered once daily; to evaluate the rationality of mentioned dose; and to identify factors associated with these concentrations. Material and Methods. A total of 24 ICU patients suffering from cerebral coma were included into this analysis. A dosage of gentamicin of 5 mg/kg body weight was administered once a day. Gentamicin concentrations were tested twice after the first dose infusion (immediately and 5 hours after 1-hour infusion). Cmax, Cmin, volume of distribution (Vd), and elimination half-life (T1/2) were obtained. Results. The mean Cmax was 17.96 (SD, 4.31) μg/mL (range, 10.30–27.87 μg/mL). The desirable Cmax (≥20 μg/mL) was reached only in 6 patients (25%). Cmin was calculated using a special pharmacokinetic program “Kinetica.” Cmin of 0.5 μg/mL was not exceeded in any patient. A correlative analysis indicated a significant inverse direct correlation between Cmax and Vd and between Cmax and treatment duration in the ICU. An inverse correlation was observed between Cmin and T1/2, evaluation of coma according to the Glasgow coma scale, and creatinine clearance. Conclusions. A dosage of 5 mg/kg body weight once a day was not sufficient in cerebral coma ICU patients. This dose was not associated with the nephrotoxic effect of gentamicin (additional risk factors were absent). [...]