Pharmacovigilance in Russia: current state of affairs,challenges, and prospects

This review outlines current issues of the pharmacovigilance (PV) system in the Russian Federation, namely the present state of regulatory aspects, regulatory requirements in both Russia and the Eurasian Economic Union, and review of causes of under-reporting of adverse drug reactions. Specific attention will be focused on how the system is designed to monitor drug safety functions, reporting and accountability of pharmaceutical products, their manufacturers and medical staff, the role played by regional centers for drug-safety monitoring, and insufficient understanding of the part taken by patients in the system of PV. The prospects of the Russian PV system and its harmonization with global practice will also be discussed.     

Effect of triacontanol on the pharmacokinetics of docetaxel in rats associated with induction of cytochrome P450 3A1/2

Abstract

1.?Triacontanol was confirmed to have a potential anti-cancer effect, the aim was to assess whether the co-administration of triacontanol alters the exposure of docetaxel via inducing hepatic CYP3A1/2 activity. The concentration of docetaxel in rats pretreated with triacontanol for seven successive days was determined, and the expression levels of CYP3A protein and mRNA were analyzed by the western blot and real time polymerase chain reaction (RT-PCR) technique, respectively.

2.?The concentrations of docetaxel in rats pretreated with triacontanol were decreased, with 61.5%, 61.9% decrease in AUC_0–24h and 65.7%, 54.9% reduction in C_max (120 and 180?mg?kg^?1, respectively) compared with the control. Hepatic clearance of docetaxel was enhanced in vitro and in vivo at dosage of 120 and 180?mg?kg^?1, and CYP3A activity was up-regulated by measuring the formation rate of 1-hydroxymidazolam. Triacontanol preferentially induced protein expression level of CYP3A2 in a dose-dependent manner and of CYP 3A1 at dosage of 120 and 180?mg?kg^?1. The mRNA expression of CYP3A1 was moderately different with the western blot results, but the trends appeared similar. CYP3A2 mRNA level was not markedly affected by triacontanol.

3.?The significant triacontanol–docetaxel interaction was largely due to the induction of CYP3A1/2, which brought useful information in the clinical therapy when the combination is administered in human.     

Critical Role of Trauma and Emergency Surgery Physicians in Patient Satisfaction: An Analysis of Consumer Assessment of Healthcare Providers and Systems,Hospital Version Data from 186,779 Patients and 168 Hospitals in a National Healthcare System

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Immediate therapist self-disclosure bolsters the effect of brief integrative psychotherapy on psychiatric symptoms and the perceptions of therapists: A randomized clinical trial

Objective: We report a first randomized clinical trial examining the effect of immediate and non-immediate therapist self-disclosure in the context of a brief integrative psychotherapy for mild to moderate distress. Method: A total of 86 patients with mild to moderate forms of distress were randomly divided into three 12-session integrative psychotherapy conditions based primarily on [Hill, C. E. (2009). Helping skills: Facilitating, exploration, insight, and action (3rd ed.). Washington, DC: American Psychological Association.] three-stage model. Therapists trained in this treatment modality were instructed to use either immediate self-disclosure (expressing feelings towards the patient/treatment/therapeutic relationship) or non-immediate self-disclosure (expressing personal or factual information regarding the therapist's life outside the treatment). In the comparison condition, the therapists were instructed to refrain from self-disclosure altogether. Results: Immediate therapist self-disclosure reduced psychiatric symptoms among patients with elevated pretreatment symptoms (as assessed by the Brief Symptoms Inventory) and bolstered a favorable perception of the therapist. Therapists in both the immediate and non-immediate self-disclosure group evaluated themselves more favorably than their counterparts in the non-disclosure group. Conclusions: Therapist self-disclosure, particularly of the immediate type, might enhance the effect of brief integrative treatment on psychiatric symptoms of high symptomatic patients and contribute to favorable perception of therapists.     

Nitrosamine Contamination in Pharmaceuticals: Threat,Impact, and Control

Nitrosamine-contaminated medicinal products have raised safety concerns towards the use of various drugs, not only valsartan and all tetrazole-containing angiotensin II receptor blockers, but also ranitidine, metformin, and other medicines, many of which have been recalled and prone to shortage. At any stages, from drug substance synthesis throughout each product's lifetime, these impurities may evolve if an amine reacts with a nitrosating agent coexisting under appropriate conditions. Consequently, drug regulatory authorities worldwide have established stringent guidelines on nitrosamine contamination for all drug products in the market. This review encompasses various critical elements contributing to successful control measures against current and upcoming nitrosamine issues, ranging from accumulated knowledge of their toxicity concerns and potential root causes, precise risk evaluation, as well as suitable analytical techniques with sufficient sensitivity for impurity determination. With all these tools equipped, the impact of nitrosamine contamination in pharmaceuticals should be mitigated. An evaluation aid to tackle challenges in risk identification, as well as suitable industry-friendly analytical techniques to determine nitrosamines and other mutagenic impurities, are among unmet needs that will significantly simplify the risk assessment process.     

Effect of urinary tract infection on the risk of prosthetic joint infection: A systematic review and meta-analysis

PurposeUrinary tract infection (UTI) are very common in the general population, however it is unclear whether UTI is a risk factor of prosthetic joint infection (PJI). Our purposes were: (1) To determine whether UTI is a risk factor of PJI after joint replacement, and (2) to determine whether the microorganisms causing PJI and UTI are the same.MethodsPubMed, Web of Science, the Cochrane Library, and EMBASE were searched systematically for studies. The effect sizes of RR were calculated for included studies that reported raw counts with 95% CIs. The aim 1 of the study is a meta-analysis; the aim 2 is a systematic review.ResultsThe aim 1 indicated that the risk of PJI was significantly higher in the UTI group than in the control group (RR = 3.17; 95% CI, 2.19–4.59). The aim 2 indicated that the microorganisms of UTI and PJI were the same in the same patient, and these included Enterococcus faecalis, and Pseudomonas, which supports the theory of PJI occurring via the haematogenous route from the genitourinary tract that harbours bacteria in UTI.ConclusionThis study identified UTI as being significantly associated with PJI after joint arthroplasty and PJI occurring via the haematogenous route from the genitourinary tract harbouring bacteria in UTI. Therefore, postponing surgery and even treating patients with known UTI preoperatively are recommended.