Pharmaceutical Release into the Environment during Pandemics and Regional Epidemics

政府间气候变化专门委员会指出，人口增长和气候变化可能会加剧未来流行病和大流行病的风险。鉴于这些新的社会压力，国家和国际组织大力推动制定药品准备计划。流行病和大流行性药物使用与常规使用的不同之处在于，超过35%的人口将被感染并可能用一种或多种药物治疗。大流行期间的“大剂量”药物给污水处理厂、河流水生系统和人类健康带来了前所未有的、基本上没有特征的风险。目前对药品的监管是基于常规条件下的预期使用模式，而不是在大流行或流行病期间。在目前大流行性流感风险出现之前，常规和大规模使用之间的区别并不令人担忧，大量的"季节性流感"抗病毒药物（即达菲）正在储存。在发生大流行性流感时，预计将使用数量空前的一套药品来治疗感染者，并限制大流行性流感在未感染者中的传播。每种药物都有一系列独特的潜在生态目标，包括人类。此外，混合废物流所造成的风险无法通过了解其组成部分的生态毒理学来预测。可以说，高浓度生物活性化学品的涌入可能会破坏的最关键的服务是污水处理厂（STW）。关于高浓度抗生素对污水处理厂的运行和完整性的影响知之甚少。同样，也没有关于抗病毒药物对STW或环境影响的同行评议研究。H5N1病毒目前无法在人与人之间传播，皇家学会以及世界上大多数专家认为这是不可避免的，这为我们提供了一个宝贵的、可能是短暂的机会之窗，以评估我们目前的制药准备计划的风险，并相应地加以调整。拟议的倡议将提供一个科学认识的基础，了解在大流行和流行病期间广泛使用药物的命运和影响，并建立一个多学科的成员网络，不仅能够应对和适应流感大流行，而且能够应对和适应在不久的将来可能出现的其他流行病和大流行病。在其头三年期间，该倡议将：-开发和公布一个在线知识和联网工具，以整合现有信息来源，帮助评估在流行病和流行病条件下环境中与药品有关的风险。这将为那些寻求此类信息的人提供一种机制，使他们能够迅速找到最佳资源，并帮助解释现有知识。- 举办五次知识差距确定讲习班，讨论在大流行病和流行病情况下评估药物释放到环境中的关键专业议题。- 为同行评审的期刊以及相关专业组织的内部出版物撰写文章，描述正在解决的问题，解释在线资源并报告初步调查结果。将开始发行一份特别期刊。- 举办一次会议，报告非洲经委会倡议头三年的产出，以促进进一步的知识转让，并就该倡议的长期生命达成共识。- 确定在决策和监管中使用科学知识方面可以吸取的经验教训，并就此发表报告。

The Intergovernmental Panel on Climate Change states that population growth and climate change are likely to intensify the risk of future epidemics and pandemics. In light of these new societal pressures, there has been a significant push from both national and international organizations in the establishment of pharmaceutical preparedness plans. Epidemic and pandemic pharmaceutical usage differs from conventional usage in that upwards of 35% of the population will be infected and potentially treated with one or more pharmaceuticals. The 'bolus' of pharmaceuticals during a pandemic creates unprecedented and largely uncharacterised risks to the operation of sewage treatment plants, riverine aquatic systems and human health. Current regulations on pharmaceuticals are based on intended predicted use patterns under conventional conditions, rather than during a pandemic or epidemic. The distinction between conventional and large scale usage has not been of concern prior to the emergence of the current risk of pandemic influenza, for which large quantities of 'seasonal influenza' antivirals (i.e. Tamiflu) are being stockpiled. In the event of pandemic influenza, unprecedented quantities of a suite of pharmaceutical products are expected to be used to treat the infected and limit the spread of pandemic influenza among the uninfected. With each pharmaceutical comes a unique array of potential ecological targets, including humans. Moreover, the risks posed by a mixed waste stream can not be predicted by knowledge of the ecotoxicology of its constituent parts. Arguably the most critical service that could be disrupted by the influx of high concentrations of biologically-active chemicals is sewage treatment works (STW). Little is known regarding the effect of high concentrations of antibiotics on the operation and integrity of STW. Similarly, there is no peer-reviewed research on the effect of antivirals on STW or the environment. The current inability of the H5N1 virus to transmit from human-to-human, which is considered inevitabile by The Royal Society as well as most of the world experts, provides us with a valuable and possibly brief window of opportunity to assess the risks of our current pharmaceutical preparedness plan and adapt it accordingly. The proposed Initiative will provide a foundation of scientific understanding of the fate and effect of widespread pharmaceutical use during a pandemic and epidemic and a multi-disciplinary network of members capable of responding and adapting to not only an influenza pandemic, but the likely emergence of other epidemics and pandemics in our immediate future. During its first three years the PREPARE Initiative will: - develop and publish an on-line knowledge and networking tool to integrate existing information sources that help in the assessment of risks associated with pharmaceuticals in the environment under pandemic and epidemic conditions. This will provide a mechanism for those seeking such information to be rapidly guided to the best resource and help in interpretation of available knowledge. - run five knowledge gap identification workshops, for the discussion of key specialist topics in the assessment of pharmaceutical release into the environment under pandemic and epidemic conditions. - prepare articles for both peer-reviewed journals as well as the house publications of relevant professional organisations, describing the issue being addressed by the PREPARE Initiative, explaining the on-line resource and reporting on preliminary findings. A special journal issue will be initiated. - run a conference to report on outputs of the PREPARE Initiative during its first three years, to facilitate further knowledge transfer and gather consensus on the longer-term life of the initiative. - identify the lessons that can be learned on the use of scientific knowledge in policy making and regulation and publish a report on this.