Utilization of psychotropic medicines in Romania during 1998–2018

Background: Mental disorders can have a significant impact on patients’ life, including economic, social and individual consequences, and psychotropic medication is essential to treat these conditions. Psychotropic drug utilization studies contribute to a clearer picture of the management of these conditions. Data published from Romania on this topic is limited. The present study aims to characterize the utilization patterns of anxiolytics, antidepressants (ADs), and antipsychotics (APs) in Romania during 1998–2018.Methods: Drug utilization data were provided by Management Center for Documentation, Information and Marketing (CEGEDIM) Romania and quantitative data for each psychotropic medicine were converted to total defined daily doses (DDDs) and to DDD/1000inhabitants/day (DDD/TID). The total use of medicines in DDD/TID was computed in order to obtain the drug utilization 90% (DU90%) segment.Results: An increasing trend in total utilization of psychotropic medicines in Romania started in 2004. Anxiolytics use was predominant until 2013 and the yearly anxiolytic use over the entire study period remained between 10 and 15 DDD/TID. Diazepam lost popularity over time in detriment of the utilization of other anxiolytic benzodiazepines, such as alprazolam and lorazepam. ADs utilization markedly increased during the study period (the average annual growth rate was 13.66% starting 1999). Selective serotonin reuptake inhibitors (SSRIs) became present on the 2008 DU90% and was the dominant class of ADs, with sertraline being the most prescribed, followed by escitalopram and paroxetine. APs utilization showed an increasing trend from 2003 until 2018. Atypical APs became present on the 2008 DU90%, while typical APs were no longer included in the 2018 DU90%. Among atypical APs, olanzapine was the main agent prescribed, and starting 2010 was followed by quetiapine and risperidone. The uptake of APs long-acting formulations became more evident during the last analyzed years (2015–2018).Conclusion: We observed an increasing utilization of APs and a more prominent increase in ADs utilization in Romania during 1998–2018. The anxiolytic prescribing remained nearly stable during this time. Further research can bring more information on the various factors influencing psychotropic utilization in Romania

EVALUATION OF SOME PHYTOCHEMICAL CONSTITUENTS AND THE ANTIOXIDANT ACTIVITY IN SIX ROSE HIPS SPECIES COLLECTED FROM DIFFERENT ALTITUDE OF SUCEAVA DISTRICT

In this study, species of rose hips fruits were assayed for the composition of polyphenol, flavonoids, anthocyanins contents as well as the antioxidant activity. Samples of rose hips representing six species (Rosa pendulina, R. tomentosa, R. canina, R. rubiginosa, R. corymbifera and R. nitidula) were collected from spontaneous flora of Suceava district. The smallest content of total polyphenols was recorded in R. nitidula, both in seeds (3.11mg GAE/g DW) and pulp (23.99 mg GAE/g DW). The maximum concentration of total polyphenols was found in R. pendulina, both in seeds (17.68 mg GAE/g DW) and pulp (71.48 mg GAE/g DW). The most abundant anthocyanin content in pulp of all specie studied was in R. canina (16.60 mg%). The relevant differences between pulp and seed regarding flavonoid content, about 7-fold were reached at R. tomentosa collected from Vatra Dornei. The results revealed that antioxidant activity of pulp extract from R. pendulina showed the largest scavenging activity while the lowest scavenging capacity was recorded for R. nitidula

A VigiBase Descriptive Study of Fluoroquinolone-Associated Peripheral Nervous System Disorders

Background: Recent drug safety concerns described fluoroquinolone (FQ)-induced peripheral nervous system reactions. The objective of this study was to characterize such reports from VigiBase. Methods: The analysis included FQ-induced peripheral nervous system disorder adverse drug reaction (ADR) reports (up to July 2019). We looked into the disproportionality data in terms of proportional reporting ratio (PRR) and information component (IC) values, and descriptive analysis was performed for FQ-ADRs positive associations (ADRs, suspected FQs, potential risk factors, such as associated therapy and underlying disease). Results: Disproportionality analysis revealed 4374 reports (3531 serious) with peripheral nervous system ADRs associated with at least three FQs (neuropathy peripheral, 5492; neuralgia, 481; polyneuropathy, 220; sensory loss, 99; peripheral sensorimotor neuropathy, 39). Among these, both time-to-onset and duration of reaction were mostly between 1–7 days and ≥30 days. Most of the ADRs were not recovered/resolved at the time of reporting. Conclusion: The results augment the existing data on FQ safety concerns, specifically their potential effect on the nervous system

Immunosuppressive regimens following kidney transplantation in five European countries: The observational RECORD study

Objective: To examine current immunosuppressive regimens administered to kidney transplant recipients (KTRs) in South-eastern Europe. Methods: This was a 12-month, multicenter, non- interventional, prospective, observational study of immunosuppressive regimens in adult de novo and maintenance KTRs. The primary endpoint was to identify the number, type, dosage and trough concentrations (C0) of immunosuppressive medications. Results: Data were available for 1774 KTRs from five countries (Bulgaria [n = 109], Croatia [n = 339], Romania [n = 647], Serbia [n = 434] and Slovenia [n = 245]). The most common immunosuppressive regimen in all countries was a triple therapy regimen (de novo KTRs, 67.9 – 100% at baseline and 67.3 – 100% at end of study ; maintenance KTRs, 48.8 – 90.7% and 43.2 – 90.1%, respectively). The most frequent regimen in de novo KTRs comprised tacrolimus, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), and corticosteroids. In maintenance KTRs, the most frequent regimen was tacrolimus or cyclosporine, and MMF or MPS, with or without corticosteroids. A C0 of <5 ng/mL was recorded in 40.2% of immediate-release and 48.7% of prolonged-release tacrolimus patients ; 79.5% of patients taking cyclosporine had a C0 of <75 ng/mL. Infections were the most common adverse event (358/597, 60.0%), mainly urinary tract infections (208/358, 58.1%). Conclusions: Triple therapy—comprising a calcineurin inhibitor (CNI ; tacrolimus or cyclosporine), antiproliferative drugs (MMF or MPS) and corticosteroids—was the most common immunosuppressive regimen used in KTRs in South- eastern Europe. Individual CNI C0 were below the target range in a substantial proportion of KTRs, highlighting the need to maintain therapeutic drug monitoring of immunosuppressive therapy in this patient population