RATIONAL DRUG USE: PROMOTION AND THE ROLE OF MEDICAL EDUCATION

Dünya Sağlık Örgütü tahminlerine göre tüm ilaçların yarısından fazlası uygunsuzşekilde reçete edilmekte, dağıtılmakta ya da satılmaktadır. Akılcı ilaç kullanımı,"hastaların klinik ihtiyaçlarına uygun ilaçları, kişisel gereksinimlerini karşılayandozlarda, yeterli bir süre boyunca, kendilerine ve topluma en az maliyet ilekullanmaları" olarak tanımlanmıştır. Akılcı ilaç kullanımı basamakları; doğru tanınınkonması, prognozun belirlenmesi, tedavi amaçlarının saptanması, tedavi seçenekleriningözden geçirilmesi, uygun tedavinin seçimi, gerekli ise reçetenin doğrubiçimde yazımı ve takiptir. Tüm bu süreçte ilaç dışı tedavi seçeneklerinin dikkate alınması,ilaçlar için etkililik, uygunluk, güvenlilik ve maliyet analizinin yapılması,risklerin en aza indirilmesi, doğru bilgilendirme ve hasta katılımının sağlanmasıesastır. Akılcı ilaç kullanımını yaygınlaştırmada yasal önlemler, doğru bilgiye erişim veeğitim, başta gelen araçlardır. Bu konuda dünyada ve Türkiye'de belli bir yol alınsa dailaçların kullanım sorunları devam etmektedir. Akılcı ilaç kullanmı bilincininaşılanması için örgün ve yaygın eğitim olanakları kullanılmaya ve geliştirilmeyedevam edilmelidir. Eğitim yanında, kazanılan tutum ve davranışların korunması vedesteklenmesi için gerekli idari düzenlemeler mutlaka yapılmalıdır. İlaç politikaları buyönde şekilllendirilmelidir. İlaçlardan beklenen faydalara ulaşılması bu sayedemümkün olabilir. World Health Organization estimates that more than half of all medicines areinappropriately prescribed, dispensed, or sold. Rational drug use requires that"patients receive medications appropriate to their clinical needs, in doses that meettheir own individual requirements, for an adequate period of time, and at the lowestcost to them and their community". Steps for rational drug use are diagnosingcorrectly, determining prognosis, defining treatment goals, considering treatmentoptions, choosing appropriate treatment, prescribing correctly if necessary, andfollowing up the patient. During this process, considering treatment options other thandrugs; analyzing drugs for efficacy, suitability, safety, and cost; minimizing risks;correct informing; and ensuring patient involvement are essential. Legislative actions,access to correct information, and education are central tools for promoting rational drug use. Drug use problems continue despite important advancements in Turkey andthe world. Formal and non-formal education should be continually used and improvedto promote rational drug use awareness. Beside education, necessary legislativemeasures must be taken to protect and support acquired attitudes and behaviours.Drug policies should be shaped accordingly. By this way, it could be possible toachieve the expected benefits of drugs

Tüketici temelli marka değerinin finansal performans üzerine etkisi

Gerçekleştirilen çalışmada önemi artan (tüketici temelli) marka değeri konusu ve finansal performans üzerine etkileri incelenmiştir. Tüketici gözünde oluşan marka değerinin alt boyutlarıyla ortaya konularak, bu boyutların şirkete somut finansal katkıları olup olmadığı ve katkı şekilleri Türkiye menşeli firmalar için analiz edilmiştir. Yöntem olarak çalışma, Türkiye’de tüketici temelli marka değerinin (brand equity) bir anket çalışmasından elde edilecek veriler ile belirlenmesi, firmaların finansal performansının halka açık finansal tablolardan elde edilmesi ve bu iki veri grubu arasında istatistiksel olarak anlamlı bir ilişki bulunup bulunmadığının detaylı olarak analizi ve yorumlanması şeklindedir. Tüketici temelli firma gücünün (değerinin) ölçümünde pazarlama literatüründe genel kabul gören Aaker (1991)’in önerdiği boyutlar üzerine geliştirilen çok boyutlu bir model kullanılmıştır. Aaker’in önerdiği ve çalışma içerisinde kullanılan boyutlar marka farkındalığı, algılanan kalite, marka sadakati ve marka çağrışımları olarak sıralanabilir. Bu boyutların ölçümü için geçtiğimiz yıllar içerisinde uluslararası literatürde yer alan çalışmalarda kullanılarak geçerliliği test edilmiş ölçeklerden faydalanılmıştır. Bu ölçeklerde yer alan ölçüm soruları Türkçe’ye ve Türkiye şartlarına uyarlanarak, uzman görüşleri ve pilot çalışma doğrultusunda yapılan ekleme ve değişiklikler sonucunda nihai haline getirilmiştir. Firmaların finansal performanslarının karşılaştırılabilmesi için uluslararası kabul görmüş çeşitli finansal performans göstergelerinden faydalanılmıştır. Finansal performans göstergelerinin her bir firma için değerini hesap etmekte İstanbul Menkul Kıymetler Borsası vasıtasıyla elde edilen halka açık finansal tablolar kullanılmıştır. Anahtar Kelimeler: Tüketici temelli marka değeri, marka ederi, marka sermayesi, finansal performans.This study analyzes the brand and brand equity concepts and the financial performance that is expected to be improved as a result of branding activities and brand equity. This study is carried out to understand whether the consumer based brand equity affect the firms' financial performance and the degree and type of the relationship between these if there is a significant correlation is available.In the analysis stage, the consumer based brand equity's dimensions are revealed for companies from different business sectors in Turkey and these are compared with the financial performance indicators to understand whether a statistically significant relation is visible. The methodology used may be summarized as follows: the determination of the consumer based brand equity for each firm in the study by a field study (questionnaire), the acquirement of the financial data from Istanbul Stock Exchange, calculation of related variables and factors, the detailed analysis of the consumer based data and financial data together to understand the relationships between them and finally the interpretation of the results.The model used in the determination and measurement of the consumer based brand equity in this study is fundamentally based on the model proposed by Aaker (1991) and the scale developed by Yoo and Donthu (2001). The consumer based brand equity dimensions proposed by Aaker are; "Brand awareness", "Perceived quality", "Brand loyalty", and "Brand associations". The data needed for comparing the consumer based brand equity dimensions among the firms are obtained using a questionnaire, which is applied with face-to-face interview in Istanbul to 505 subjects. The scale used for measuring these dimensions is based on popular and verified scales referenced in international literature. The questions in the mentioned scales (Yoo and Donthu, 2001; Bruner and Hensel, 2001; Bearden and Netemeyer, 1999) are translated to Turkish and are modified to give the same meaning and feeling, moreover some questions were omitted and new ones are added in the light of a pilot study and expert opinions. The companies and brand that are included in this study are selected using the following criteria: publicly listed companies (to be able to have audited and comparable financial performance data), companies with a family brand (to be able to use the firm's financial data as the brand's data), not operating in the financial services sector (as the performance indicators are different in this sector). A total of 28 firms are included in the study. The questionnaire is structured to include; brand experience, category knowledge, consumer based brand equity dimensions (perceived quality, brand awareness, brand associations and brand loyalty), attitude towards brand, purchase intention, demographical and socio-economic-status questions. The internationally accepted financial ratios used in the study for comparison of financial performance between the firms may be listed as: Annual return on shares, Firm Value / Market Value, Price / Earnings, Price / Net Sales per share, EBITDA / Net Sales, Return on Assets, Operational Profit, Net Sales, Market Value, Financial Leverage Ratio, Current Ratio, and Annual Change in Net Sales. The balance sheets, income statements and related annotations that are publicly available through the Istanbul Stock Exchange for years 2007 and 2006 are used as data in calculating the aforementioned financial performance measures for the companies included in the study. The data obtained through questionnaires and from publicly available financials are processed and analyzed. An explanatory factor analysis is carried out to derive the brand equity dimensions from the questionnaire. Three different factors are obtained as a result of the factor analysis. These three factors of the brand equity are then used as the independent variables in the regression analysis with the financial performance measures, which are entered as dependent variables. As an outcome of the statistical analysis conducted, it has been seen that the consumer based brand equity positively affects most of the financial performance indicators to varying extents. Keywords: Consumer based brand equity, financial performance

Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID‑19 (Bari‑SolidAct): a randomised, double‑blind, placebo‑controlled phase 3 trial

Background Baricitinib has shown efcacy in hospitalized patients with COVID-19, but no placebo-controlled trials have focused specifcally on severe/critical COVID, including vaccinated participants. Methods Bari-SolidAct is a phase-3, multicentre, randomised, double-blind, placebo-controlled trial, enrolling participants from June 3, 2021 to March 7, 2022, stopped prematurely for external evidence. Patients with severe/ critical COVID-19 were randomised to Baricitinib 4 mg once daily or placebo, added to standard of care. The primary endpoint was all-cause mortality within 60 days. Participants were remotely followed to day 90 for safety and patient related outcome measures. Results Two hundred ninety-nine patients were screened, 284 randomised, and 275 received study drug or placebo and were included in the modifed intent-to-treat analyses (139 receiving baricitinib and 136 placebo). Median age was 60 (IQR 49–69) years, 77% were male and 35% had received at least one dose of SARS-CoV2 vaccine. There were 21 deaths at day 60 in each group, 15.1% in the baricitinib group and 15.4% in the placebo group (adjusted absolute diference and 95% CI −0.1% [−8·3 to 8·0]). In sensitivity analysis censoring observations after drug discontinuation or rescue therapy (tocilizumab/increased steroid dose), proportions of death were 5.8% versus 8.8% (−3.2% [−9.0 to 2.7]), respectively. There were 148 serious adverse events in 46 participants (33.1%) receiving baricitinib and 155 in 51 participants (37.5%) receiving placebo. In subgroup analyses, there was a potential interaction between vaccination status and treatment allocation on 60-day mortality. In a subsequent post hoc analysis there was a signifcant interac‑ tion between vaccination status and treatment allocation on the occurrence of serious adverse events, with more respiratory complications and severe infections in vaccinated participants treated with baricitinib. Vaccinated partici‑ pants were on average 11 years older, with more comorbidities. Conclusion This clinical trial was prematurely stopped for external evidence and therefore underpowered to con‑ clude on a potential survival beneft of baricitinib in severe/critical COVID-19. We observed a possible safety signal in vaccinated participants, who were older with more comorbidities. Although based on a post-hoc analysis, these fnd‑ ings warrant further investigation in other trials and real-world studies

Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial

© The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.[Background] Baricitinib has shown efficacy in hospitalized patients with COVID-19, but no placebo-controlled trials have focused specifically on severe/critical COVID, including vaccinated participants.[Methods] Bari-SolidAct is a phase-3, multicentre, randomised, double-blind, placebo-controlled trial, enrolling participants from June 3, 2021 to March 7, 2022, stopped prematurely for external evidence. Patients with severe/critical COVID-19 were randomised to Baricitinib 4 mg once daily or placebo, added to standard of care. The primary endpoint was all-cause mortality within 60 days. Participants were remotely followed to day 90 for safety and patient related outcome measures.[Results] Two hundred ninety-nine patients were screened, 284 randomised, and 275 received study drug or placebo and were included in the modified intent-to-treat analyses (139 receiving baricitinib and 136 placebo). Median age was 60 (IQR 49–69) years, 77% were male and 35% had received at least one dose of SARS-CoV2 vaccine. There were 21 deaths at day 60 in each group, 15.1% in the baricitinib group and 15.4% in the placebo group (adjusted absolute difference and 95% CI − 0.1% [− 8·3 to 8·0]). In sensitivity analysis censoring observations after drug discontinuation or rescue therapy (tocilizumab/increased steroid dose), proportions of death were 5.8% versus 8.8% (− 3.2% [− 9.0 to 2.7]), respectively. There were 148 serious adverse events in 46 participants (33.1%) receiving baricitinib and 155 in 51 participants (37.5%) receiving placebo. In subgroup analyses, there was a potential interaction between vaccination status and treatment allocation on 60-day mortality. In a subsequent post hoc analysis there was a significant interaction between vaccination status and treatment allocation on the occurrence of serious adverse events, with more respiratory complications and severe infections in vaccinated participants treated with baricitinib. Vaccinated participants were on average 11 years older, with more comorbidities.[Conclusion] This clinical trial was prematurely stopped for external evidence and therefore underpowered to conclude on a potential survival benefit of baricitinib in severe/critical COVID-19. We observed a possible safety signal in vaccinated participants, who were older with more comorbidities. Although based on a post-hoc analysis, these findings warrant further investigation in other trials and real-world studies. Trial registration Bari-SolidAct is registered at NCT04891133 (registered May 18, 2021) and EUClinicalTrials.eu (2022-500385-99-00).EU-SolidAct is part of the European pandemic preparedness network EU RESPONSE, funded by the EU Horizon 2020 Research and Innovation programme, under grant number 101015736. EU-SolidAct has also received funding from CAPNET (France) and Klinbeforsk (Norway).Peer reviewe

Antimanic Treatment with Tamoxifen Affects Brain Chemistry: A Double-Blind, Placebo-Controlled Proton Magnetic Resonance Spectroscopy Study

© 2016 Society of Biological Psychiatry.Background The antimanic efficacy of a protein kinase C inhibitor, tamoxifen, has been tested in several clinical trials, all reporting positive results. However, mechanisms underlying the observed clinical effects require further confirmation through studies of biological markers. Methods We investigated the effect of tamoxifen versus placebo on brain metabolites via a proton magnetic resonance spectroscopy study. Scanning was performed in 48 adult manic patients with bipolar disorder type I (mean Young Mania Rating Scale score of 37.8 ± 5.8) at baseline and after 3 weeks of double-blind treatment. We hypothesized that alleviation of manic symptoms would improve the levels of markers associated with brain energy metabolism (creatine plus phosphocreatine [total creatine (tCr)]) and neuronal viability (N-acetylaspartate). Results The Young Mania Rating Scale scores decreased from 38.6 ± 4.5 to 20.0 ± 11.1 in the tamoxifen group and increased from 37.0 ± 6.8 to 43.1 ± 7.8 in the placebo group (p <.001). Proton magnetic resonance spectroscopy measurements revealed a 5.5% ± 13.8% increase in tCr levels in dorsomedial prefrontal cortex in the tamoxifen group and a 5.3% ± 13.1% decrease in tCr in the placebo group (p =.027). A significant correlation between the Young Mania Rating Scale score change and tCr percent change was observed in the whole group (Spearman rho =.341, p =.029). Levels of both tCr and N-acetylaspartate in the responder group were increased by 9.4% ± 15.2% and 6.1% ± 11.7%, respectively, whereas levels in the nonresponder group were decreased by 2.1% ± 13.2% and 6.5%± 10.5%, respectively (p <.05). Conclusions Tamoxifen effectively treated mania while increasing brain tCr levels, consistent with involvement of both excessive protein kinase C activation and impaired brain energy metabolism in the development of bipolar manic states