Prescribing assessment: Are final year medical students competent to prescribe antibiotics rationally?

Introduction: The rational use of drugs, especially antibiotics, has been recognized as a serious problem worldwide. Aim: The purpose of this study was to evaluate the practical skills of Bulgarian medical students in their final year of education to prescribe antibiotics rationally as well as the impact of a training focused specifically on avoiding prescription errors. Materials/Methods: Medical students from the Medical University of Sofia in their 10th semester of education from two consecutive teaching cycles took part in this study. The students' participation was completely voluntary. The study was performed as academic study after having obtained a positive opinion from the Local Ethics Committee of the University Hospital 'Tsaritsa Joanna-ISUL', Medical University of Sofi a. The study was planned to be conducted in two separate parts: a pilot study aimed at receiving basic information about the self-assessment confidence of the medical students in prescribing drugs and especially antibiotics rationally and comparing this to their actual prescribing competence and a subsequent pivotal study after having performed a thorough analysis of the results of the pilot study with implementation of the respective corrective measures. The students' perception of their theoretical knowledge and practical skills to prescribe drugs and especially antibiotics rationally was assessed by means of a questionnaire containing 5 questions whereas their level of antibiotic prescribing competence was assessed by means of solving three simulated patient cases. The appropriateness of written therapeutic prescriptions was assessed independently by two clinical pharmacologists using a three-grade assessment scale: 'good', 'satisfactory' and 'unsatisfactory'. Results: The results of the pilot study showed that 50.35% of the prescriptions were rated as 'good', 21.64% as 'satisfactory' and 28.01% as 'unsatisfactory'. The results obtained from the subsequent pivotal study showed that 60.97% of the prescriptions were rated as 'good' (representing a 21.1% increase), 16.23% as 'satisfactory' (representing a 25% decrease) and 22.80% as 'unsatisfactory' (representing an 18.6% decrease). This was accompanied by an increase in the students' self-assessment confidence rated as 'good' - from 19.15% to 34.21%, while 'satisfactory' and 'unsatisfactory' ratings decreased - from 65.96% to 55.26% and from 14.89% to 10.53%, respectively. Conclusions: Medical students from the Medical University of Sofi a showed a level of competence to prescribe antibiotics rationally commensurable with the level report ed by foreign medical universities. Regardless of the observed discrepancy between the self-assessment rating and the practical antibiotic prescribing skills it was clearly shown that education specifically focused on prescription errors may contribute to the improvement of the students' antibiotic prescribing competence

Comparative bioavailability of a newly developed Irbesartan 300 mg containing preparation

Introduction: Irbesartan (CAS registry: 138402-11-6) is a potent, orally active, selective antagonist of the angiotensin II receptors (type AT1) indicated for the treatment of arterial hypertension and chronic heart failure. Aim: The objective of the present study was to demonstrate the bioequivalence of an oral test preparation (Irbesartan 300 mg film-coated tablets Tchaikapharma High Quality Medicines Inc., Bulgaria) and a reference (Aprovel 300 mg film-coated tablets, Sanofi Clir SNC, France), by comparing the rate and extent of absorption of both products upon a single oral administration of the tablets under fasting conditions in healthy volunteers. Methodology: The study was carried out as a single-center, open-label, randomised, twoperiod, single dose, crossover oral bioequivalence study in 40 healthy male and female subjects under fasting conditions. During each study period blood samples for analysis of irbesartan were taken prior to dosing and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours after dosing. The separated plasma was analyzed in the bioanalytical division of Anapharm Europe with a validated method using reversed phase high performance liquid chromatography coupled to a tandem mass spectrometry detector (RP-LC/MS/MS). Results: The point estimates with 90% confidence intervals of the geometric mean ratios of test and reference (T/R) in the study were found to be 102.39% (95.55% - 109.71%) for Cmax and 98.56 % (92.72 % - 104.76 %) for AUC0-72. Thus, the corresponding ratios of Cmax and AUC0-72 met the predetermined criteria for bioequivalence (90% confidence intervals of the geometric mean ratios of test and reference within the 80.00% - 125.00%). Both products were generally very well tolerated. Conclusions: Irbesartan 300 mg film-coated tablets, Tchaikapharma High Quality Medicines Inc., Bulgaria) and Aprovel 300 mg film-coated tablets (Sanofi Clir SNC, France), are bioequivalent with regard to the rate and extent of absorption

Pharmacodynamic approach for proving equivalence of two ophtalmic solutions containing Brimonidine Tartarate 0.2% in healthy volunteers

Introduction: Bromonidine tartarate ophthalmic solution (CAS registry-number: 70359- 46-5) is a relatively selective alpha-2 adrenergic agonist, indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Aim: The purpose of the present phase-1 clinical trial was to assess the pharmacodynamic equivalence of two ophtalmic solutions containing brimonidine tartarate 0,2% in healthy volunteers. Methods: The study was performed as a single center, randomized, single-dose, observer-blinded, single period trial in 36 healthy volunteers. Each volunteer received successively and in a random way a single dose of 1 drop of the test or the reference product in the conjunctival sac of the right and left eye, respectively. Measurement of intraocular pressure (IOP) of both eyes was performed at screening examination, pre-dose and 2 hours post dosing and at final examination by means of a Goldmann applanation tonometer. The primary target parameter for proving pharmacodynamic equivalence was defined as the absolute decrease in IOP 2 hours post dose. The 95% confidence interval was calculated for the difference (test-reference) of the primary target parameter and compared with the predefined equivalence range of ±1.5 mmHg. Results: A decrease in the IOP of 4.60±1.26 mmHg and 4.40±0.89 mmHg was observed after administration of the test and reference formulation, respectively. The mean difference was +0.197 mmHg with a 95% confidence interval between -0.275 and 0.670 mmHg and thus entirely within the predefined equivalence range. Both products showed a very good local safety profile and similar tolerability. Conclusion: Brimonidine Tartrate Ophthalmic Solution 0.2% was pharmacodynamically equivalent to the reference preparation (Alphagan®) with respect both to efficacy and safety

Corporate Cash Holdings in the Shipping Industry

We examine the corporate cash holdings of listed shipping companies and show that shipping firms hold more cash than similar firms in other asset-heavy industries. Higher cash holdings in the shipping industry are not attributable to firm- or country-level characteristics, but rather to the higher marginal value of cash. Shipping firms value an additional dollar of cash higher than matched manufacturing firms, regardless of their financial constraints status, but depending on their cultural background and the cyclicality of their expansion opportunities. Less procyclical shipping firms have a higher marginal value of cash, and this valuation effect is most pronounced in bad times of the business cycle when external capital supply tends to becomescarce.Overall, it appears that shipping companies are more conservative than their peers in managing their cash positions

Harmonizing and improving European education in prescribing: An overview of digital educational resources used in clinical pharmacology and therapeutics

Aim: Improvement and harmonization of European clinical pharmacology and therapeutics (CPT) education is urgently required. Because digital educational resources can be easily shared, adapted to local situations and re-used widely across a variety of educational systems, they may be ideally suited for this purpose. Methods: With a cross-sectional survey among principal CPT teachers in 279 out of 304 European medical schools, an overview and classification of digital resources was compiled. Results: Teachers from 95 (34%) medical schools in 26 of 28 EU countries responded, 66 (70%) of whom used digital educational resources in their CPT curriculum. A total of 89 of such resources were described in detail, including e-learning (24%), simulators to teach pharmacokinetics and/or pharmacodynamics (10%), virtual patients (8%), and serious games (5%). Together, these resources covered 235 knowledge-based learning objectives, 88 skills, and 13 attitudes. Only one third (27) of the resources were in-part or totally free and only two were licensed open educational resources (free to use, distribute and adapt). A narrative overview of the largest, free and most novel resources is given. Conclusion: Digital educational resources, ranging from e-learning to virtual patients and games, are widely used for CPT education in EU medical schools. Learning objectives are based largely on knowledge rather than skills or attitudes. This may be improved by including more real-life clinical case scenarios. Moreover, the majority of resources are neither free nor open. Therefore, with a view to harmonizing international CPT education, more needs to be learned about why CPT teachers are not currently sharing their educational materials

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