尼日利亚市售仿制药的活性药物成分等效性（EQUIMEDS）：进一步监测的理由。

Equivalence in Active Pharmaceutical Ingredient of Generic Antihypertensive Medicines Available in Nigeria (EQUIMEDS): A Case for Further Surveillance.

机构信息

Faculty of Medicine and Health, Westmead Applied Research Centre, University of Sydney, Sydney, Australia.

Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom.

出版信息

Glob Heart. 2019 Sep;14(3):327-333. doi: 10.1016/j.gheart.2019.07.006.

DOI:10.1016/j.gheart.2019.07.006

PMID:31451241

Abstract

BACKGROUND

Widespread access to good quality antihypertensive medicines is a critical component for reducing premature cardiovascular disease (CVD) mortality. Poor-quality medicines pose serious health concerns; however, there remains a knowledge gap about the quality of cardiovascular medicines available in low- and middle-income countries.

OBJECTIVES

The aim of this study was to determine the quality of generic antihypertensive medicines available in the retail market of a developing country.

METHODS

Samples of the 2 most commonly prescribed classes of antihypertensive medicines were collected from 3 states in 3 different geopolitical zones in Nigeria following a semirandom sampling framework. Medicine samples were purchased by mystery shoppers from 22 pharmacy outlets from 6 local government areas across the 3 states. Medicine quality was determined by measuring the amount of stated active pharmaceutical ingredient using high-performance liquid chromatography with photodiode array detection and classified according to their compliance to the specified pharmacopeia tolerance limits for each antihypertensive drug.

RESULTS

Amlodipine and lisinopril were identified as the most commonly prescribed antihypertensive drugs in Nigeria. In total, 361 samples from 22 pharmacies were collected and tested. In total, 24.6% of amlodipine and 31.9% of lisinopril samples were of substandard quality and significantly more samples purchased in rural (59 of 161, 36.7%) compared with urban (32 of 200, 16%) outlets were found to be of substandard quality (p < 0.001). No falsified samples of either amlodipine or lisinopril were detected. There was large variation in price paid for the antihypertensive medicines (range ₦150 to ₦9,750). Of the 24 pharmacy outlets surveyed, 46% stated that patients did not always require a prescription and 21% had previously reported a medicine as falsified or substandard.

CONCLUSIONS

More than one-quarter of some commonly prescribed antihypertensive medicines available in Nigeria may be of substandard quality. Enhanced quality assurance processes in low- and middle-income countries, such as Nigeria, are needed to support optimum management.

摘要

背景

广泛获得高质量的降压药物是降低心血管疾病（CVD）过早死亡率的关键组成部分。质量差的药物会对健康造成严重威胁；然而，关于中低收入国家可用的心血管药物的质量，仍存在知识空白。

目的

本研究旨在确定发展中国家零售市场上可获得的常用降压药物的质量。

方法

按照半随机抽样框架，从尼日利亚 3 个州的 3 个不同地缘政治区域采集了 2 种最常开的降压药物样本。由神秘顾客从 6 个地方政府区域的 22 家药店购买药物样本。通过使用高效液相色谱法和光电二极管阵列检测来测量规定的活性药物成分的量，确定药物质量，并根据每种降压药物的药典公差限制来分类。

结果

氨氯地平和赖诺普利被确定为尼日利亚最常开的降压药物。总共从 22 家药店收集并测试了 361 个样本。氨氯地平的不合格样本占 24.6%，赖诺普利的不合格样本占 31.9%，并且在农村（161 个中的 59 个，36.7%）购买的样本比在城市（200 个中的 32 个，16%）更不合格（p < 0.001）。没有检测到氨氯地平和赖诺普利的假冒样本。这些降压药物的价格差异很大（范围为₦150 到₦9,750）。在所调查的 24 家药店中，46%表示患者并不总是需要处方，21%曾报告过某种药物为假冒或不合格。