Southern African Development Community (SADC), PO Box 95, Gaborone, Botswana.
BMC Health Serv Res. 2012 Sep 3;12:297. doi: 10.1186/1472-6963-12-297.
Generic Medicines are an important policy option allowing for access to affordable, essential medicines. Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities. Existing negative perceptions surrounding the quality of generic medicines must be addressed to ensure that people use them with confidence. Campaigns to increase the uptake of generic medicines by consumers and providers of healthcare need to be informed by local norms and practices. This study sought to compare South African consumers' and healthcare providers' perceptions of quality of generics to the actual quality of selected products.
The study was conducted at the local level in three cities of South Africa: Johannesburg, Durban and Cape Town. Purposive sampling was used to recruit consumer participants (n = 73) and random sampling used to recruit healthcare providers from public and private sectors (n = 15). Data were obtained through twelve focus group discussions with consumers and semi-structured interviews (n = 15) with healthcare providers in order to gain familiarity with perceptions of quality. One hundred and thirty five products comprising paracetamol tablets (n = 47), amoxicillin capsules (n = 45) and hydrochlorothiazide tablets (n = 43) were sourced from public and private sector healthcare providers. These products were subjected to in vitro dissolution, uniformity of weight and identity (Fourier Transformed Infrared Spectroscopy) tests using prescribed methods from the British (2005) and United States Pharmacopeias (2006).
Respondents described drug quality in relation to the effect on symptoms. Procurement and use behavior of healthcare providers was influenced by prior experience, manufacturers' names and consumers' ability to pay. All formulations passed the in vitro tests for quality.
This study showed clear differences between perceptions of quality and actual quality of medicines suggesting deficiencies in public engagement by government regarding the implementation of generic medicines policy. Implementation of generic medicines policy requires the involvement of consumers and healthcare providers to specifically address their information gaps and needs.
仿制药是一种重要的政策选择，可以提供负担得起的基本药物。国家药品监管部门必须通过开展活动来保证仿制药的质量。必须解决围绕仿制药质量的负面看法，以确保人们有信心使用它们。为了提高消费者和医疗保健提供者对仿制药的接受程度，需要根据当地的规范和做法开展宣传活动。本研究旨在比较南非消费者和医疗保健提供者对仿制药质量的看法与选定产品实际质量之间的差异。
该研究在南非的三个城市（约翰内斯堡、德班和开普敦）进行。通过在当地采用目的抽样法招募消费者参与者（n=73），采用随机抽样法招募来自公共和私营部门的医疗保健提供者（n=15）。通过与消费者进行的 12 次焦点小组讨论和与医疗保健提供者进行的半结构化访谈（n=15）获取数据，以熟悉对质量的看法。从公共和私营部门医疗保健提供者处获取了包含对乙酰氨基酚片（n=47）、阿莫西林胶囊（n=45）和氢氯噻嗪片（n=43）的 135 个产品。这些产品根据英国（2005 年）和美国药典（2006 年）规定的方法进行了体外溶出度、重量均匀度和身份（傅里叶变换红外光谱）测试。
受访者描述了与症状效果有关的药物质量。医疗保健提供者的采购和使用行为受到先前经验、制造商名称和消费者支付能力的影响。所有制剂均通过体外质量测试。
本研究表明，对药物质量的看法与药物实际质量之间存在明显差异，这表明政府在实施仿制药政策方面缺乏公众参与。实施仿制药政策需要消费者和医疗保健提供者的参与，以专门解决他们的信息差距和需求。
