A Cross-Sectional Study To Assess The Knowledge Of Pharmacy Students About Drug Pollution In Spain.

The presence of pharmaceuticals in the environment is an issue of growing concern. The European Commission adopted the "European Union Strategic Approach to Pharmaceuticals in the Environment", which focuses on actions to reduce the risk of pharmaceuticals in the environment, including how environmental aspects can become part of medical training programmes. OBJECTIVE: Obtain data from pharmacy students about pharmaceutical pollution to provide information about the training needs that may help develop new actions related to the training and dissemination of this issue. METHOD: 1614 pharmacy students from five Schools of Pharmacy in Spain completed a self-administered questionnaire consisting on 24 questions: 13 about knowledge, 8 related to attitude and 3 to opinion. RESULTS: Around 75% of students reported that they did not know "One Health "or "emerging pollutant" concepts and around 88% declared that they did not know that diclofenac caused a catastrophic vulture decline in Asia. The importance of this topic and their attitude to acquiring new knowledge was evaluated higher than 8 points out of 10, while received training during their studies was a score of 2.8 points out of 10. CONCLUSION: The knowledge about key concepts was relatively poor. In fact, they judged training about pharmaceuticals in the environment during their pharmacy studies was very scarce. However, students consider that drug pollution is a very important issue and have a very good attitude towards acquiring knowledge in it.

Knowledge and attitude about drug pollution in pharmacy students: A questionnaire-based cross sectional study.

INTRODUCTION: The environmental impact of drugs or pharmaceuticals is an issue of growing concern. Healthcare professionals, and pharmacists in particular, are used to managing medicines, yet aspects about drug pollution are generally neglected in schools of pharmacy worldwide. Formation in this issue is essential to tackle the problem. In this study, we aimed to find out the degree of knowledge about the problem of pharmaceuticals in the environment and the attitude about the matter of pharmacy students at the University of the Basque Country. METHODS: We conducted a pilot study (186 students) using an online questionnaire available in two languages (Basque and Spanish). The attitude scale was validated for Spanish. To improve participation, a combination of indirect and direct recruitment was applied in the final study. RESULTS: Four hundred eighty-seven students participated in the final study (response rate: 65.8%). The final questionnaire contained a total of 25 questions: 13 (knowledge), eight (attitude), and three (opinion). The results showed that knowledge can be considered relatively poor, whereas attitude was generally positive, and students considered drug pollution to be a relevant issue in general and in pharmacy practice. CONCLUSIONS: We believe there is an urgent need to include aspects about pharmaceuticals in the environment in pharmacy studies worldwide.

Pharmacokinetic/Pharmacodynamic Analysis of Oral Calcium Fosfomycin: Are Urine Levels Sufficient to Ensure Efficacy for Urinary Tract Infections?

Urinary tract infections (UTIs) are extremely common and a major driver for the use of antimicrobials. Calcium fosfomycin is an old antibiotic indicated for the treatment of UTIs; however, data about its urine pharmacokinetic profile are scarce. In this work, we have evaluated the pharmacokinetics of fosfomycin from urine concentrations after oral administration of calcium fosfomycin to healthy women. Moreover, we have assessed, by pharmacokinetic/pharmacodynamic (PK/PD) analysis and Monte Carlo simulations, its effectiveness considering the susceptibility profile of Escherichia coli, the main pathogen involved in UTIs. The accumulated fraction of fosfomycin excreted in urine was around 18%, consistent with its low oral bioavailability and its almost exclusively renal clearance by glomerular filtration as unchanged drug. PK/PD breakpoints resulted to be 8, 16, and 32 mg/L for a single dose of 500 mg, a single dose of 1000 mg, and 1000 mg q8h for 3 days, respectively. For empiric treatment, the estimated probability of treatment success was very high (>95%) with the three dose regimens, considering the susceptibility profile of E. coli reported by EUCAST. Our results show that oral calcium fosfomycin at a dose level of 1000 mg every 8 h provides urine concentrations sufficient to ensure efficacy for the treatment of UTIs in women.

Randomized, Crossover and Single-Dose Bioquivalence Study of Two Oral Desogestrel Formulations (Film-Coated Tablets of 75 µg) in Healthy Female Volunteers.

Despite the increase in the substitution of branded medicinal product with generic drugs, this is a controversial issue for some pharmacological groups (such as contraceptives).The aim of the present clinical trial was to assess the bioequivalence and tolerability of two oral formulations of desogestrel.Thirty-three healthy female volunteers participated in this randomized and two-way crossover study. During two separate experimental periods, with at least four weeks of washout period, women received a single oral dose of 75 µg of desogestrel from each of the formulations (test formulation and reference formulation). Desogestrel bioavailability was determined by the measurement of 3-ketodesogestrel plasma concentration.Pharmacokinetic parameters were comparable and the 90% CI for the ratio of C(max) (96.14-114.53%) and AUC(0-t) (105.73-123.83%) values for the test and reference formulations fell within the established regulatory interval (80-125%). Both formulations were also comparable in terms of tolerability.From the results of this study it can be concluded that test formulation (desogestrel 75 µg, Cyndea PHARMA S.L.) is bioequivalent to the reference formulation (Cerazet® 75 µg, Organon Española S.A.).

Randomised, crossover clinical trial, in healthy volunteers, to compare the systemic availability of two topical intranasal budesonide formulations.

BACKGROUND: Budesonide has a long history as intranasal drug, with many marketed products. Efforts should be made to demonstrate the therapeutic equivalence and safety comparability between them. Given that systemic availability significantly varies from formulations, the clinical comparability of diverse products comes to be of clinical interest and a regulatory requirement. The aim of the present study was to compare the systemic availability, pharmacodynamic effect, and safety of two intranasal budesonide formulations for the treatment of rhinitis. METHODS: Eighteen healthy volunteers participated in this randomised, controlled, crossover, clinical trial. On two separated days, subjects received a single dose of 512 mug budesonide (4 puffs per nostril) from each of the assayed devices (Budesonida nasal 64(R), Aldo-Union, Spain and Rhinocort 64(R), AstraZeneca, Spain). Budesonide availability was determined by the measurement of budesonide plasma concentration. The pharmacodynamic effect on the hypothalamic-adrenal axis was evaluated as both plasma and urine cortisol levels. Adverse events were tabulated and described. Budesonide availability between formulations was compared by the calculation of 90%CI intervals of the ratios of the main pharmacokinetic parameters describing budesonide bioavailability. Plasma cortisol concentration-time curves were compared by means of a GLM for Repeated Measures. Urine cortisol excretion between formulations was compared through the Wilcoxon's test. RESULTS: All the enrolled volunteers successfully completed the study. Pharmacokinetic parameters were comparable in terms of AUC(t) (2.6 +/- 1.5 vs 2.2 +/- 0.7), AUC(i) (2.9 +/- 1.5 vs 2.4 +/- 0.7), t(max) (0.4 +/- 0.1 vs 0.4 +/- 0.2), C(max)/AUC(i) (0.3 +/- 0.1 vs 0.3 +/- 0.0), and MRT (5.0 +/- 1.4 vs 4.5 +/- 0.6), but not in the case of C(max) (0.9 +/- 0.3 vs 0.7 +/- 0.2) and t(1/2) (3.7 +/- 1.8 vs 2.9 +/- 0.4). The pharmacodynamic effects, measured as the effect over plasma and urine cortisol, were also comparables between both formulations. No severe adverse events were reported and tolerance was comparable between formulations. CONCLUSION: The systemic availability of intranasal budesonide was comparable for both formulations in terms of most pharmacokinetic parameters. The pharmacodynamic effect on hypothalamic-pituitary-adrenal axis was also similar. Side effects were scarce and equivalent between the two products. This methodology to compare different budesonide-containing devices is reliable and easy to perform, and should be recommended for similar products intented to be marketed or already on the market. TRIAL REGISTRATION: No Eudra CT: 2005-003727-39.