Colombo Giorgio L, Agabiti-Rosei Enrico, Margonato Alberto, Mencacci Claudio, Montecucco Carlo Maurizio, Trevisan Roberto, Catapano Alberico L
Department of Drug Sciences, University of Pavia, Italy.
Division of Medicine and Surgery, Spedali Civili, Brescia, Italy.
Atheroscler Suppl. 2016 Jun;21:1-8. doi: 10.1016/j.atherosclerosissup.2016.02.001. Epub 2016 Feb 13.
The use of generics, equivalent but less expensive drugs, is an important opportunity to reduce healthcare expenditure.
The purpose of this study was to investigate the effect of substitution between unbranded generics on persistence and adherence to therapy in two Italian Local Health Units (ASL) in real-world clinical practice in 5 therapeutic areas using tracing drugs. Substitution of generic drugs is any change in the name of the manufacturer of the generic drug. The therapeutic areas were: diabetes (metformin); hypertension (amlodipine); dyslipidemia (simvastatin); psychiatry (sertraline); cardiology (propafenone); osteoporosis (alendronate). The retrospective analysis was carried out on the administrative databases of two Local Healthcare Units (ASL - Azienda sanitaria locale Bergamo (BG) and Pavia (PV)) in the Lombardy Region of Italy. The correlation between persistence and adherence with the different cohorts of generic substitution frequency within each therapeutic area was then calculated.
According to the inclusion criteria, 23,773 patients were evaluated. Patients were observed for a period of 36 months starting from the first drug delivery (index date). The median age of the overall population was above 61 years in all therapeutic areas. The generic drug substitution occurred in 61.5% of patients (BG: 57.6% and PV: 65.4% respectively); Hypertension was the therapeutic area with the highest percentage of patients with substitutions. Patients' adherence, evaluated by the Medical Possession Rate (MPR) and persistence to the treatment decreases with the increase in the frequency of generic substitutions. This observation was confirmed by a statistically significant negative correlation (p-value of <0.001) between the adherence and persistence and the number of generic substitutions in each therapeutic area and Local Healthcare Units (ASL).
Adherence is one of the pillars of the patient's health management in the control and prevention of progression of the disease. Several factors, such as ageing, comorbidities, and polypharmacy, may affect adherence and influence the outcome of treatments. These results are in line with studies supporting the possibility that the change of package appearance each time a new prescription is dispensed may create confusion and ultimately reduce patients' adherence. Clinicians and decision makers should consider the impact of frequent generic substitutions on persistence and adherence, which may influence efficacy and/or safety.
使用仿制药（等效但价格较低的药物）是降低医疗保健支出的重要契机。
本研究的目的是在意大利的两个地方卫生单位（ASL）中，采用追踪药物的方法，调查在5个治疗领域的实际临床实践中，无品牌仿制药之间的替换对治疗持续性和依从性的影响。仿制药的替换是指仿制药制造商名称的任何变化。治疗领域包括：糖尿病（二甲双胍）；高血压（氨氯地平）；血脂异常（辛伐他汀）；精神病学（舍曲林）；心脏病学（普罗帕酮）；骨质疏松症（阿仑膦酸盐）。对意大利伦巴第大区两个地方医疗单位（ASL——贝加莫（BG）和帕维亚（PV）的地方卫生机构）的行政数据库进行回顾性分析。然后计算每个治疗领域内不同仿制药替换频率队列的持续性和依从性之间的相关性。
根据纳入标准，评估了23773名患者。从首次给药（索引日期）开始，对患者进行了36个月的观察。所有治疗领域中总体人群的中位年龄均在61岁以上。61.5%的患者发生了仿制药替换（BG：57.6%，PV：65.4%）；高血压是替换患者比例最高的治疗领域。通过药物持有率（MPR）评估的患者依从性和治疗持续性随着仿制药替换频率的增加而降低。在每个治疗领域和地方医疗单位（ASL）中，依从性和持续性与仿制药替换次数之间存在统计学显著负相关（p值<0.001），这证实了上述观察结果。
依从性是患者疾病控制和预防进展的健康管理的支柱之一。几个因素，如老龄化、合并症和多药治疗，可能会影响依从性并影响治疗结果。这些结果与支持每次开具新处方时包装外观的变化可能会造成混乱并最终降低患者依从性的研究一致。临床医生和决策者应考虑频繁的仿制药替换对持续性和依从性的影响，这可能会影响疗效和/或安全性。
