生物谷報(bào)道：Munir Pirmohamed及其同事在近期《英國(guó)醫(yī)學(xué)雜志》（BMJ）的社論中認(rèn)為,，發(fā)展中國(guó)家需要建立藥物安全監(jiān)測(cè)系統(tǒng),，世界衛(wèi)生組織需要帶頭找到資助這些活動(dòng)的新方式。
他們寫道,，醫(yī)藥公司正在面臨越來(lái)越大的壓力,，讓它們掃清發(fā)展中國(guó)家在獲取有效藥物方面面臨的障礙，但是這些運(yùn)動(dòng)并沒(méi)有伴隨著相應(yīng)的建立藥品監(jiān)督系統(tǒng)的工作,。
只有不到27%的發(fā)展中國(guó)家建立了機(jī)制,，來(lái)追蹤和分享在一個(gè)世衛(wèi)組織全球項(xiàng)目中注冊(cè)的藥物安全信息。但是發(fā)達(dá)國(guó)家產(chǎn)生的藥品安全性情況并不會(huì)必然發(fā)生在發(fā)展中國(guó)家,，在發(fā)展中國(guó)家,，藥物不良反應(yīng)可能由于環(huán)境和遺傳影響而不同,。
Pirmohamed及其同事呼吁在進(jìn)行藥物研究的科學(xué)家、制藥公司和各國(guó)政府之間進(jìn)行合作,，把它們的信息存入同一個(gè)數(shù)據(jù)庫(kù)中,。
他們認(rèn)為，公共衛(wèi)生部門,、獲取藥品運(yùn)動(dòng)的組織者以及現(xiàn)有的區(qū)域監(jiān)督系統(tǒng)應(yīng)該建立類似的協(xié)作關(guān)系,，獲取在人口統(tǒng)計(jì)學(xué)方面相關(guān)的大量數(shù)據(jù)。他們說(shuō),，最終目的應(yīng)該是讓每一個(gè)國(guó)家都建立一套融入全球數(shù)據(jù)庫(kù)的藥物安全系統(tǒng),。
原始出處：
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.
