BMJ：全球数据库对发展中国家药物安全至关重要

    生物谷报道：Munir  Pirmohamed及其同事在近期《英国医学杂志》（BMJ）的社论中认为，发展中国家需要建立药物安全监测系统，世界卫生组织需要带头找到资助这些活动的新方式。

    他们写道，医药公司正在面临越来越大的压力，让它们扫清发展中国家在获取有效药物方面面临的障碍，但是这些运动并没有伴随着相应的建立药品监督系统的工作。

    只有不到27%的发展中国家建立了机制，来追踪和分享在一个世卫组织全球项目中注册的药物安全信息。但是发达国家产生的药品安全性情况并不会必然发生在发展中国家，在发展中国家，药物不良反应可能由于环境和遗传影响而不同。

    Pirmohamed及其同事呼吁在进行药物研究的科学家、制药公司和各国政府之间进行合作，把它们的信息存入同一个数据库中。

    他们认为，公共卫生部门、获取药品运动的组织者以及现有的区域监督系统应该建立类似的协作关系，获取在人口统计学方面相关的大量数据。他们说，最终目的应该是让每一个国家都建立一套融入全球数据库的药物安全系统。

原始出处：
BMJ  2007;335:462 (8 September), doi:10.1136/bmj.39323.586123.BE

Editorials

Pharmacovigilance in developing countries

Requires collaboration between stakeholders to develop novel models of funding

Efforts are increasing to ensure that resource poor countries, which bear almost 90% of the global disease burden, have access to effective medicines.1 As a result, drug companies are facing increased pressure from governments, the World Health Organization, and patient lobby groups to remove legal and financial barriers to access.2 However, although these campaigns are necessary and clearly laudable, they are not accompanied by the development or upscaling of processes for monitoring drug safety. Although many drugs have been extensively used and studied in developed countries (thus informing global practice), their safety profile cannot necessarily be generalised to developing countries, where the incidence, pattern, and severity of adverse reactions may differ markedly because of local environmental and genetic influences.3

After the thalidomide disaster in the 1960s, most Western countries developed national pharmacovigilance systems.4 These systems use spontaneous reporting or other pharmacoepidemiological methods to systematically collect and analyse adverse events associated with the use of drugs, identify signals or emerging problems, and communicate how to minimise or prevent harm. Although these processes are not perfect, as exemplified by recent problems,5 they do provide evidence that can be used to institute regulatory action to protect public health.

At the global level, the WHO programme for international drug monitoring at the Uppsala Monitoring Centre collates adverse drug reaction reports via the national pharmacovigilance centres of the 81 member countries (www.who-umc.org). However, currently only six sub-Saharan African countries (South Africa, Zimbabwe, Tanzania, Mozambique, Nigeria, and Ghana) are full members of the programme. In fact, less than 27% of lower middle income and low income economies have national pharmacovigilance systems registered with the WHO programme, compared with 96% of the high income countries in the Organisation for Economic Co-operation and Development. The main reasons for this are lack of resources, infrastructure, and expertise. Thus, although access to medicines is increasing in developing countries, there is a danger that their risk benefit profiles in indigenous populations will not be fully monitored and acted upon.

So what can be done to improve drug safety monitoring in developing countries? In the short term, we need to make better use of ongoing or planned studies. The ability to detect an adverse drug reaction depends on its frequency and the total number of people exposed to the drug.6 A logical approach would be to encourage collaboration between academic investigators, drug companies, and governments undertaking clinical studies to develop common adverse reaction reporting forms and to deposit the data into a single database.

Similar partnerships could also be established with organisers of public health and drug access campaigns and with regional surveillance systems, such as the East African network for monitoring antimalarial treatment7 and the network for assessing health and demography in developing countries.8 The operational advantages of this approach are that data can be obtained from a range of studies and that pre-existing manual and technical infrastructures can be used to acquire the data. This would provide demographically relevant data from large (and less homogeneous) populations in a structured and systematic fashion, and these data could then be used to identify warning signals.

Individual investigators would still own their data and publish results of their trials, but the pooling of data on adverse drug reactions would add value to ongoing studies. This has already happened on a small scale. For example, an increased risk of serious neurological reactions was identified in people taking ivermectin who were infected with Loa loa before treatment started.9 Such pooling of data needs to be increased and considered for all drug classes within a formulary.

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