Lee Jian Lynn, Mohd Saffian Shamin, Makmor-Bakry Mohd, Islahudin Farida, Alias Hamidah, Ali Adli, Mohamed Shah Noraida
Centre for Quality Management of Medicines, Faculty of Pharmacy, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
Department of Pharmacy, Tengku Ampuan Rahimah Hospital, Ministry of Health Malaysia, Selangor Darul Ehsan, Malaysia.
Front Pharmacol. 2022 Jun 9;13:879287. doi: 10.3389/fphar.2022.879287. eCollection 2022.
Rational use of drug involves the use of medicine as per clinical guidelines. Given the steady increase in the clinical utility of intravenous immunoglobulin (IVIG) either as licensed or off-label use, concerns are being raised about the possibility of supply shortages that could significantly impact patient care. Therefore, there is a need to regulate and to promote the rational use of this valuable medication. This cross-sectional chart review study attempts to evaluate the prescribing patterns of IVIG at two tertiary hospitals in Malaysia. Patients' medical files and dispensing records were examined and compared with current guidelines. A total of 348 prescriptions for IVIG were written during the 1-year study period. The highest usage of IVIG was for neurological (47.9%), immunological (27.5%), and hematological conditions (20%). The number of prescriptions with the US Food and Drug Administration (FDA) licensed indications and off-label indications was 148 (42.5%) and 200 (57.5%), respectively. Age (OR: 1.02, 95% CI: 1.01-1.03, = 0.003) and those admitted to the critical care units (OR: 11.11, 95% CI: 5.60-22.05, < 0.001) were significant factors for receiving IVIG for an off-label indication. Most prescriptions (79%) had appropriate dosing. Significant factors associated with receiving inappropriate dose of IVIG include age (OR: 0.93, 95% CI: 0.89-0.97, = 0.001) and those admitted to the critical care units (OR: 10.15, 95% CI: 3.81-27.06, < 0.001). This study advocates the development and implementation of evidence-based clinical guidelines with prioritization protocol to ensure rational use of IVIG.
合理用药涉及按照临床指南使用药物。鉴于静脉注射免疫球蛋白(IVIG)无论是作为获批用途还是超说明书用途,其临床效用都在稳步增加,人们对供应短缺可能严重影响患者治疗的可能性日益担忧。因此,有必要对这种宝贵药物的使用进行规范并促进其合理使用。这项横断面图表回顾研究试图评估马来西亚两家三级医院IVIG的处方模式。检查了患者的病历和配药记录,并与现行指南进行了比较。在为期1年的研究期间,共开出了348份IVIG处方。IVIG使用最多的是神经系统疾病(47.9%)、免疫性疾病(27.5%)和血液系统疾病(20%)。具有美国食品药品监督管理局(FDA)获批适应症和超说明书适应症的处方数量分别为148份(42.5%)和200份(57.5%)。年龄(比值比:1.02,95%置信区间:1.01 - 1.03,P = 0.003)以及入住重症监护病房的患者(比值比:11.11,95%置信区间:5.60 - 22.05,P < 0.001)是接受超说明书适应症IVIG治疗的重要因素。大多数处方(79%)的剂量是合适的。与接受不适当剂量IVIG相关的重要因素包括年龄(比值比:0.93,95%置信区间:0.89 - 0.97,P = 0.001)以及入住重症监护病房的患者(比值比:10.15,95%置信区间:3.81 - 27.06,P < 0.001)。本研究提倡制定并实施基于证据的临床指南以及优先排序方案,以确保IVIG的合理使用。
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