safetyriskБезопасность и риск фармакотерапииSafety and Risk of Pharmacotherapy2312-78212619-1164Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/2312-7821-2025-481safetyrisk-481Research ArticleГЛАВНАЯ ТЕМА: БЕЗОПАСНОСТЬ ПАЦИЕНТА: КАК ДОКЛИНИЧЕСКИЕ ДАННЫЕ И ПОСТРЕГИСТРАЦИОННЫЙ ФАРМАКОНАДЗОР ФОРМИРУЮТ СОВРЕМЕННЫЙ ЛАНДШАФТ ФАРМАКОТЕРАПИИMAIN TOPIC: PATIENT SAFETY: THE WAY PRECLINICAL DATA AND POST-AUTHORISATION PHARMACOVIGILANCE SHAPE MODERN PHARMACOTHERAPEUTIC LANDSCAPEЛекарственно-индуцированная аллергия у взрослых в многопрофильном стационаре: оценка распространенности методом глобальных триггеровDrug Allergy in Adults at a Multidisciplinary Hospital: Prevalence Assessment Using the Global Trigger Toolhttps://orcid.org/0009-0009-8771-1983КовальВ. Р.KovalV. R.

Коваль Виктория Рустамовна

ул. Миклухо-Маклая, д. 6, Москва, 117198

Victoria R. Koval

6 Miklukho-Maklay St., Moscow 117198

shcherbakova_vr@pfur.ruhttps://orcid.org/0000-0001-7729-2169БутрановаО. И.ButranovaO. I.

Бутранова Ольга Игоревна, канд. мед. наук, доцент

ул. Миклухо-Маклая, д. 6, Москва, 117198

Olga I. Butranova, Cand. Sci. (Med.), Associate Professor

6 Miklukho-Maklay St., Moscow 117198

butranova-oi@rudn.ruhttps://orcid.org/0009-0001-3112-8117КонстантиноваТ. Г.KonstantinovaT. G.

Константинова Татьяна Геннадьевна

ул. Миклухо-Маклая, д. 6, Москва, 117198

Tatiana G. Konstantinova

6 Miklukho-Maklay St., Moscow 117198

Figurabon25@gmail.comhttps://orcid.org/0009-0006-3296-8990Аль-МайяхиА.К.Ш.Al-MayahiA.Q.S.

Аль-Майяхи Ахмед Касим Шархан

ул. Миклухо-Маклая, д. 6, Москва, 117198

Ahmed Q.S. Al-Mayahi

6 Miklukho-Maklay St., Moscow 117198

Ahmed.kasim201@gmail.comФедеральное государственное автономное образовательное учреждение высшего образования «Российский университет дружбы народов имени Патриса Лумумбы»РоссияPeoples’ Friendship University of Russia named after Patrice LumumbaRussian Federation202529092025133313323Copyright © Коваль В.Р., Бутранова О.И., Константинова Т.Г., Аль-Майяхи А., 20252025Коваль В.Р., Бутранова О.И., Константинова Т.Г., Аль-Майяхи А.Koval V.R., Butranova O.I., Konstantinova T.G., Al-Mayahi A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.risksafety.ru/jour/article/view/481ВВЕДЕНИЕ

ВВЕДЕНИЕ. Лекарственно-индуцированные аллергические реакции (ЛИАР) у госпитализированных пациентов ограничивают возможности рациональной фармакотерапии и увеличивают риск полипрагмазии в связи с необходимостью коррекции состояния пациента и назначения противоаллергических препаратов. Объективная оценка частоты ЛИАР в стационаре и структуры препаратов для коррекции назначений является актуальной задачей, решение которой позволит как достичь значимого улучшения клинических исходов пациентов, так и снизить бремя затрат системы здравоохранения. Метод глобальных триггеров основан на анализе медицинской документации и фиксировании определенных триггеров, что делает его легко применимым в клинической практике.ЦЕЛЬ. Изучение возможности использования метода глобальных триггеров для оценки распространенности ЛИАР у пациентов многопрофильного стационара.МАТЕРИАЛЫ И МЕТОДЫ. Ретроспективное фармакоэпидемиологическое исследование медицинской документации пациентов, госпитализированных в ГБУЗ «Городская клиническая больница № 24 Департамента здравоохранения города Москвы» в период с 01.10.2022 по 01.04.2023, с использованием метода глобальных триггеров. Критерии включения: пациенты, проходившие стационарное лечение в отделениях терапевтического и хирургического профиля в указанный период. Критерии исключения: пациенты отделения аллергологии.РЕЗУЛЬТАТЫ. Всего за анализируемый период в отделения терапевтического и хирургического профилей поступили 8934 пациента. Триггеры ЛИАР были идентифицированы у 229 (2,6%, то есть 2563 на 100 000 пациентов). Оценка листов назначений, дневников и клинико-лабораторных данных позволила выявить лишь 52 истинных триггера ЛИАР (22,7%). В оставшихся 177 случаях (77,3%) противоаллергический препарат был назначен до или одномоментно с подозреваемым лекарственным средством, предположительно с целью профилактики возможного развития аллергической реакции, что оценивали как ложный триггер. Основными группами подозреваемых препаратов явились антибактериальные средства для системного применения (22 препарата (40,7%), в частности бета-лактамные антибиотики — 14 препаратов (20,3%)), а также моноклональные антитела (21 препарат (38,9%)).

ВЫВОДЫ

ВЫВОДЫ. Истинная частота развития ЛИАР составила 0,58% (582 на 100 000 пациентов). Продемонстрированные в исследовании результаты показали эффективность применения метода глобальных триггеров для выявления случаев лекарственной аллергии в реальной клинической практике. Исключение ложных триггеров (прежде всего профилактических назначений лекарственных препаратов) уменьшает искажение реальной частоты ЛИАР и гипердиагностики данного состояния.

INTRODUCTION

INTRODUCTION. Allergic drug reactions in hospitalised patients limit the opportunities for rational pharmacotherapy and increase the risk of polypharmacy due to the need for managing the patient’s condition and prescribing anti-allergic agents. An objective assessment of the prevalence of inpatient allergic drug reactions and a categorisation of medicinal products are critical for treatment adjustment and will lead to both a significant improvement in clinical outcomes for patients and a reduction in the financial burden for the healthcare system. The Global Trigger Tool (GTT) methodology is based on analysing medical records and capturing specific triggers, which makes the GTT easily applicable in clinical practice.

AIM

AIM. This study aimed to investigate the applicability of the GTT in studying the prevalence of allergic drug reactions in patients admitted to a multidisciplinary hospital.

MATERIALS AND METHODS

MATERIALS AND METHODS. This study used the GTT in retrospective pharmacoepidemiological analysis of medical records of patients admitted to City Clinical Hospital 24 of the Moscow City Health Department from 1 October 2022 to 1 April 2023. The study included medical records of patients treated in the internal medicine and surgery departments during the specified period and excluded those of allergology patients.

RESULTS

RESULTS. A total of 8,934 patients were admitted to the internal medicine and surgery departments during the analysed period. Triggers suggestive of allergic drug reactions were identified in 229 (2.6%) of their medical records. This would correspond to a prevalence of 2,563 cases per 100,000 patients. However, the analysis of prescriptions, diary cards, and clinical and laboratory findings identified only 52 (22.7%) true triggers of allergic drug reactions. In the remaining 177 (77.3%) cases, the triggers were classified as false positives, as anti-allergic agents were prescribed before or concomitantly with the suspected medicinal product, presumably, to prevent potential allergic reactions. The main groups of medicinal products suspected to cause allergic reactions were systemic antimicrobial agents (22 (40.7%) products, in particular, 14 (20.3%) beta-lactam antibiotics) and monoclonal antibodies (21 (38.9%) products).

CONCLUSIONS

CONCLUSIONS. The true prevalence of allergic drug reactions was 0.58%, which corresponds to 582 cases per 100,000 patients. The study demonstrated the effectiveness of the GTT in identifying allergic drug reactions in real-world clinical practice. The exclusion of false triggers, first of all, anti-allergic agents prescribed as prophylaxis, significantly reduces the bias in estimating the true prevalence of allergic drug reactions and the risk of overdiagnosis.

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The authors declare that there are no conflicts of interest present.