通用抗高血压药物的物理化学等效性（EQUIMEDS）：药品质量评估方案
Physicochemical equivalence of generic antihypertensive medicines (EQUIMEDS): protocol for a quality of medicines assessment.
作者信息
Redfern Julie, Adedoyin Rufus Adesoji, Ofori Sandra, Anchala Raghupathy, Ajay Vamadevan S, De Andrade Luciano, Zelaya Jose, Kaur Harparkash, Balabanova Dina, Sani Mahmoud U
机构信息
The George Institute for Global Health, Sydney Medical School, University of Sydney, Camperdown, New South Wales, Australia.
Department of Medical Rehabilitation, College of Health Sciences, Obafemi Awolowo University, Ile-Ife, Nigeria.
出版信息
BMJ Glob Health. 2016 Sep 28;1(2):e000086. doi: 10.1136/bmjgh-2016-000086. eCollection 2016.
BACKGROUND
Prevention and optimal management of hypertension in the general population is paramount to the achievement of the World Heart Federation (WHF) goal of reducing premature cardiovascular disease (CVD) mortality by 25% by the year 2025 and widespread access to good quality antihypertensive medicines is a critical component for achieving the goal. Despite research and evidence relating to other medicines such as antimalarials and antibiotics, there is very little known about the quality of generic antihypertensive medicines in low-income and middle-income countries. The aim of this study was to determine the physicochemical equivalence (percentage of active pharmaceutical ingredient, API) of generic antihypertensive medicines available in the retail market of a developing country.
METHODS
An observational design will be adopted, which includes literature search, landscape assessment, collection and analysis of medicine samples. To determine physicochemical equivalence, a multistage sampling process will be used, including (1) identification of the 2 most commonly prescribed classes of antihypertensive medicines prescribed in Nigeria; (2) identification of a random sample of 10 generics from within each of the 2 most commonly prescribed classes; (3) a geographical representative sampling process to identify a random sample of 24 retail outlets in Nigeria; (4) representative sample purchasing, processing to assess the quality of medicines, storage and transport; and (5) assessment of the physical and chemical equivalence of the collected samples compared to the API in the relevant class. In total, 20 samples from each of 24 pharmacies will be tested (total of 480 samples).
DISCUSSION
Availability of and access to quality antihypertensive medicines globally is therefore a vital strategy needed to achieve the WHF 25×25 targets. However, there is currently a scarcity of knowledge about the quality of antihypertensive medicines available in developing countries. Such information is important for enforcing and for ensuring the quality of antihypertensive medicines.
背景
普通人群高血压的预防和优化管理对于实现世界心脏联盟（WHF）到2025年将心血管疾病（CVD）过早死亡率降低25%的目标至关重要，而广泛获取优质降压药物是实现该目标的关键组成部分。尽管有关于抗疟药和抗生素等其他药物的研究和证据，但对于低收入和中等收入国家的仿制药降压药质量却知之甚少。本研究的目的是确定在一个发展中国家零售市场上可得的仿制药降压药的物理化学等效性（活性药物成分，API的百分比）。
方法
将采用观察性设计，包括文献检索、情况评估、药品样本的收集和分析。为了确定物理化学等效性，将使用多阶段抽样过程，包括：（1）确定尼日利亚最常处方的两类降压药；（2）从这两类最常处方的药物中各随机抽取10种仿制药；（3）进行地理代表性抽样过程，以确定尼日利亚24个零售网点的随机样本；（4）购买代表性样本、处理以评估药品质量、储存和运输；（5）将收集的样本与相关类别中的API进行物理和化学等效性评估。总共将对24家药店每家的20个样本进行测试（共480个样本）。
讨论
因此，在全球范围内提供和获取优质降压药物是实现WHF 25×25目标所需的一项重要战略。然而，目前对于发展中国家可得的降压药质量缺乏了解。此类信息对于执行和确保降压药质量很重要。
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