Abstract
A Drug-Related Problem is an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes.The aim of the study was the analysis of the adverse drug reactions (ADR) associated with prescription of the non-steroidal anti-inflammatory drugs (NSAIDs) using the DRP PCNE V5.01 qualification system.Materials and methods. The objects of the study were 415 notification forms about adverse drug reactions of NSAIDs recorded in the regional database of spontaneous reports and called ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period from 1 January 2009 to 31 December of 2018. The study and analysis of the problems associated with drugs were carried out using the qualification system DRP PCNE V5.01 (Pharmaceutical Care Network Europe) 2006 in the modification of Prof. Zimenkovsky.Results. Among other representatives of the NSAID group, Ibuprofen and Diclofenac became the “leaders” in the incidence of ADR. The frequency of ADR cases for Ibuprofen was 142 reports (34.22% of the total number of ADR for NSAIDs), and for Diclofenac it was 90 cases (21.69%). The calculation of DRP values for each of the presented cases made it possible to determine that in 81 (19.51%) and 91 (21.9%) cases, the DRP value was 6 and 7, respectively. DRP values in the range of 8–10 were found in 92 reports. The highest DRPs value was observed after the administration of Parecoxib (13 problems but only one case was found in the database), the DRPs value of Dexketoprofen was 12.5 (95% CI: 7–17) and the DRPs value of Diclofenac combinations was 10 DRPs; 95% CI: 5–17 DRP). The minimum DRPs values were associated with Naproxen, Rofecoxib, and Etoricoxib prescriptions.Conclusion. Using the DRP system in the analysis of NSAIDs, ADRs allow to identify the medicines which have a high risk of causing safety problems, such as Parecoxib, Dexketoprofen and Diclofenac combinations. The prescription of these drugs should be carried out with special cautions and control to the indications and contraindications, the dose and duration of treatment, as well as to a possible interaction of them with concomitant drugs.
Highlights
Выявление случаев развития нежелательных реакций (НР) при применении препаратов группы нестероидных противовоспалительных средств (НПВС) проводился с учетом кодов Анатомо-терапевтически-химической (АТХ) классификации лекарственных средств Всемирной организации здравоохранения [23], данных инструкций Государственных реестров лекарственных средств Российской Федерации и Украины
The aim of the study was the analysis of the adverse drug reactions (ADR) associated with prescription of the non-steroidal anti-inflammatory drugs (NSAIDs) using the DRP PCNE V5.01 qualification system
The objects of the study were 415 notification forms about adverse drug reactions of NSAIDs recorded in the regional database of spontaneous reports and called ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period from 1 January 2009 to 31 December of 2018
Summary
Количество карт-извещений от общего количества случаев НР на НПВС, % 34,22 21,69 10,84 10,60 5,54 3,37. Распределение частоты отдельных значений DRP для препаратов группы. Следующий этап работы был посвящен изучению значений DRP для отдельных представителей препаратов группы НПВС. НР НПВС показал, что наиболее высокие значения DRP наблюдались при назначении парекоксиба – 13 проблем (зарегистрирован 1 случай), декскетопрофена – 12,5 DRP (95%ДИ: 7 – 17) и комбинированных препаратов, содержащих диклофенак – 10 DRP (95% ДИ: 5 – 17 DRP). Средние значения DRP/случай в пределах 9–9,5 наблюдались при применении кеторолака, мелоксикама и ацеклофенака. Обращают на себя внимание высокие показатели максимальных значений DRP для кеторолака и мелоксикама (20 и 19 DRP соответственно), что свидетельствует о нерациональном назначении препаратов и высоком риске развития серьезных НР при их применении. Таблица 2 – Показатели медианы, максимальных и минимальных значений DRP для случаев развития НР при применении препаратов группы НПВС
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