Researcher:
Gülmez, Sinem Ezgi

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Faculty Member

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Sinem Ezgi

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Gülmez

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Gülmez, Sinem Ezgi

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2018 - 201932020 - 20226

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Researcher Of Publications: search.filters.isAuthorOfPublication.51e18e19-ce88-4ca3-901e-39cf8adbb340

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    Toward kidney-specific causality assessment tool
    (Elsevier, 2022) Kaya, Mustafa; Duru, Merve; Gülmez, Sinem Ezgi; Faculty Member; School of Medicine; 281312
    Purpose: Current nonspecific causality assessment tools lack the assessment of drug-induced acute kidney injury (DIAKI). We recently published an editorial letter for developing a specific causality assessment tool for DIAKI. The purpose of the present review was to suggest the possible required parameters and outline the path to developing a kidney-specific causality assessment tool (KSCAT).Methods: A stepwise approach for developing a KSCAT is important as this will be first version of this new tool. Thus, as a first step, we performed a screening of previously published articles on nonspecific and liver-specific causality assessment tools to define possible parameters. The suggested parameters for KSCAT fall into 3 categories: (1) drug-related; (2) kidney-related; and (3) terminology. A tri-polar method was then created that consists of definitive adverse drug reactions (ADRS), terminology, and without ADRS to suggest that the new KSCAT be efficient, specific, user friendly, and less time-consuming. Finally, a pyramid model is suggested to offer the perspectives of experts in the fields of pharmacovigilance, pharmacoepidemiol-ogy, and nephrology, as well as decision makers, while developing a KSCAT.Findings: Causality assessment tools, either non-specific or organ-specific, fall into 3 categories: (1) expert judgment; (2) algorithms; and (3) probabilistic methods. None of the current causality assessment tools is sufficient for assessing the causality of kidney -related ADRs and for screening the expanded definition of ADR included in European Union Directive 2010/84/EU.Implications: The causal relationship between drug(s) and DIAKI may be difficult and may not be assessed appropriately with the use of nonspecific tools or approaches. The aim of this article was to reiterate the need for KSCAT development and to propose the associated steps by stating the main principles: namely, the definition of ADR, suggested parameters to be included in the KSCAT, and integration of technology. Our ultimate desire is to invite experts to develop this new tool using an interdisciplinary approach and to benefit from our review in pursuing the next steps. The development of a KSCAT should start with regular and interdisciplinary consortium meetings of experts; the tool should then be tested for its usability, specificity, and practicality; and, finally, it should be used in real-life pharmacovigilance practices, as well as in research by health authorities, regulators, decision -makers, scientists, and clinicians. A KSCAT would support the provision of reliable and reproducible measures of the relationship likelihood in suspected cases of ADR to overcome uncertainty and provide a standardized approach. (Clin Ther. 2022;44:e59-e75.)(c) 2022 Elsevier Inc.
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    Developing kidney-specific causality assessment tool
    (Adis Int Ltd, 2022) Kaya, Mehmet; Duru, Merve; Gülmez, Sinem Ezgi; Faculty Member; School of Medicine; 281312
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    Nsaids and paracetamol-induced hepatotoxicity: asystematic review and meta-analysis of observational studies
    (Wiley, 2021) Nafisi, Sara; N/A; Baygül, Arzu Eden; Gülmez, Sinem Ezgi; Faculty Member; Faculty Member; School of Medicine; School of Medicine; 272290; 281312
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    Need for causality assessment tool for drug-induced acute kidney injury
    (Elsevier, 2019) Duru, Merve; Meydan, Osman; Kaya, Mustafa; N/A; Gülmez, Sinem Ezgi; Faculty Member; School of Medicine; 281312
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    Footprints of clinical pharmacology in Turkey: past, present, and future
    (Elsevier, 2020) Aydin, Volkan; Akici, Ahmet; N/A; Gülmez, Sinem Ezgi; Faculty Member; School of Medicine; 281312
    Clinical pharmacology is an interdisciplinary field that encompasses all components of the relationship between drugs and humans. All clinical pharmacology professionals aim to support an improved quality of drug-oriented health services by providing teaching, research, and routine health care services that ensure more tolerable and more effective, suitable, and cost-effective use of drugs. Subsections of clinical pharmacology include clinical trials, pharmacoepidemiology and drug use, pharmacovigilance, pharmacoeconomics, the rational use of medicines, pharmacotherapy consultation, drug monitoring, counseling to authorities and industry, pharmacogenetics, and other practices. By approaching these subsections as part of 3 main aspects of clinical pharmacology-education, research, and health care-this review aims to provide local and international practitioners with detailed information about clinical pharmacology practices in Turkey and to contribute to building the network of communication and collaboration. This review also aims to play an encouraging and pioneering role for Turkey's national community and other countries that have not yet made clinical pharmacology functional in improving the quality of health services, promoting the dissemination of rational use of medicines, helping the set-up of clinical pharmacology organizations, enhancing quantity and quality of the clinical pharmacology workforce, and increasing the infrastructural facilities. (C) 2020 Elsevier Inc. All rights reserved.
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    Antibacdus-pan: antibacterial utilization among adult patients at Koc University Hospital before and during COVID-19 pandemic within 12-months period: a hospital pharmacoepidemiology study
    (Wiley, 2022) Gülmez, Sinem Ezgi; Güldan, Mustafa; Uçar, Ege Anıl; Karakuş, Mehmet Batuhan; Şahin, Selin Merve; Şişman, Uluman; Baygül, Arzu Eden; Faculty Member; Undergraduate Student; Undergraduate Student; Undergraduate Student; Undergraduate Student; Undergraduate Student; Undergraduate Student; Faculty Member; Koç University Research Center for Translational Medicine (KUTTAM) / Koç Üniversitesi Translasyonel Tıp Araştırma Merkezi (KUTTAM); School of Medicine; School of Medicine; School of Medicine; School of Medicine; School of Medicine; School of Medicine; School of Medicine; 281312; N/A; N/A; N/A; N/A; N/A; 272290
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    Risk of hospital admission for liver injury in users of nsaids and nonoverdose paracetamol: preliminary results from the epiham study
    (Wiley, 2018) Ünal, Ülkü Sur; Lassalle, Regis; Chartier, Anais; Grolleau, Adeline; Moore, Nicholas; N/A; Gülmez, Sinem Ezgi; Faculty Member; School of Medicine; Koc University Hospital; 281312
    Purpose The SALT study found similar per-user risks of acute liver failure (ALF) leading to transplantation (ALFT) between NSAIDs and a threefold higher risk in nonoverdose paracetamol (NOP) users. The objective of EPIHAM was to identify the risks of hospital admission for acute liver injury (ALI) associated with NSAIDs and NOP. Methods Results Case-population study in the 1/97 sample of the French population claims database. Acute liver injury was identified from hospital discharge summaries, from 2009 to 2013. Exposure for cases was dispensing of NSAID or NOP resulting in exposure within 30 days before admission. Population exposure was the number of patients using the drugs over the study timeframe and total number of DDD dispensed. of 63 cases of ALI, 13 had been exposed to NSAIDs and 24 to NOP. Events per million DDD (95% CI) ranged from 0.46 (0.09-1.34) (ketoprofen) to 1.43 (0.04-7.97) (diclofenac combinations), 0.43 (0.23-0.73) all NSAIDs combined, 0.58 (0.37-0.86) for NOP. There was no association with average duration of treatment. Per patient risk ranged from 19.5 (5.31-49.9) (ibuprofen) per million users to 37.2 (19.8-63.6) all NSAIDs combined, 58.0 (37.2-86.3) for NOP. There was a linear relationship between average treatment duration and per-user risk (R-2 = 0.51, P < .05 for NSAIDs, R-2 = 0.97, P < .01 for NOP). Conclusions Risk of hospital admission for ALI with NSAIDs and NOP was similar and indicative of a dose and duration-related effect (pharmacological) effect. Acute liver injury rates were not predictive of ALFT risk.
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    Fourth-year rational pharmacotherapy clerkship at Koc University School of Medicine
    (Springer Heidelberg, 2019) N/A; Gülmez, Sinem Ezgi; Özcan, Gülnihal; Orer, Hakan S.; Faculty Member; Faculty Member; Faculty Member; School of Medicine; School of Medicine; School of Medicine; 281312; 185014; 53477
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    PublicationOpen Access
    Antipacdus-pan: antibacterial utilization among adult patients before and during COVID-19 Pandemic within 12-months period: a tertiary hospital pharmacoepidemiology study
    (Design Oriented Community (DOC), 2022) Uçar, Ege Anıl; Karakuş, Mehmet Batuhan; Güldan, Mustafa; Şahin, Selin Merve; Şişman, Uluman; Baygül, Arzu Eden; Gülmez, Sinem Ezgi; Undergraduate Student; Undergraduate Student; Undergraduate Student; Faculty Member; Koç University Research Center for Translational Medicine (KUTTAM) / Koç Üniversitesi Translasyonel Tıp Araştırma Merkezi (KUTTAM); School of Medicine; N/A; N/A; N/A; N/A; N/A; 272290; 281312
    Objective: irrational use of antibacterials is a concern during the COVID-19 pandemic. Hospital pharmacoepidemiology studies are important for evaluating the rational use of medicines, especially antibacterials, during pandemics. Defined daily doses (DDD) and drug utilization 90% (DU90%) are established methods for the evaluation of drug utilization. We aimed to evaluate antibacterial utilization in a tertiary hospital setting at Koç University Hospital (KUH). Materials and methods: this cross-sectional, descriptive study was retrospectively conducted with data extracted from KUH Inpatient Electronic Order System (CP) and was carried out for a period of one year. Antibacterial utilization of adult (aged ? 18 years) inpatients, who were prescribed at least one type of systemic antibacterial (ATC code J01), was evaluated using the recommended parameter DDD/100 admission and compared between 6 months before COVID-19 and during COVID-19 periods. March 11, 2020, the very first COVID-19 diagnosed case in Turkey, was set as the cutoff date of the 6-month period for the selection of the compared antibacterials using the DU90% method. Results: finally, 3280 of 5942 and 2605 of 4942 prescriptions for pre-COVID-19 and COVID-19 periods were included, respectively. Antibacterial utilization according to DDD/100 admissions increased from 193.96 to 201.26 DDD/100 admissions after the initiation of COVID-19 pandemic. The most utilized antibacterials were piperacillin and enzyme inhibitors in pre-COVID-19 period, whereas meropenem was utilized the most during COVID-19 period. Azithromycin utilization increased by 656.24%, whereas clarithromycin utilization decreased by 52.12%. Antibacterials were utilized most in general surgery department, with an increase of 17.57%. Conclusion: there is an increase in antibacterial utilization in KUH during COVID-19 pandemic, especially reserved antibacterials, which is a concern for antibacterial resistance.