Mubyazi Godfrey M, Gonzalez-Block Miguel A
National Institute For Medical Research, Department of Health Systems and Policy Research, Centre for Enhancement of Effective Malaria Interventions, PO Box 9653, Dar es Salaam, United Republic of Tanzania.
Malar J. 2005 Oct 20;4:51. doi: 10.1186/1475-2875-4-51.
Research is an essential tool in facing the challenges of scaling up interventions and improving access to services. As in many other countries, the translation of research evidence into drug policy action in Tanzania is often constrained by poor communication between researchers and policy decision-makers, individual perceptions or attitudes towards the drug and hesitation by some policy decision-makers to approve change when they anticipate possible undesirable repercussions should the policy change as proposed. Internationally, literature on the role of researchers on national antimalarial drug policy change is limited.
To describe the (a) role of researchers in producing evidence that influenced the Tanzanian government replace chloroquine (CQ) with sulfadoxine-pyrimethamine (SP) as the first-line drug and the challenges faced in convincing policy-makers, general practitioners, pharmaceutical industry and the general public on the need for change (b) challenges ahead before a new drug combination treatment policy is introduced in Tanzania.
In-depth interviews were held with national-level policy-makers, malaria control programme managers, pharmaceutical officers, general medical practitioners, medical research library and publications officers, university academicians, heads of medical research institutions and district and regional medical officers. Additional data were obtained through a review of malaria drug policy documents and participant observations were also done.
In year 2001, the Tanzanian Government officially changed its malaria treatment policy guidelines whereby CQ--the first-line drug for a long time was replaced with SP. This policy decision was supported by research evidence indicating parasite resistance to CQ and clinical CQ treatment failure rates to have reached intolerable levels as compared to SP and amodiaquine (AQ). Research also indicated that since SP was also facing rising resistance trend, the need for a more effective drug was indispensable but for an interim 5-10 year period it was justifiable to recommend SP that was relatively more cost-effective than CQ and AQ. The government launched the policy change considering that studies (ethically approved by the Ministry of Health) on therapeutic efficacy and cost-effectiveness of artemisinin drug combination therapies were underway. Nevertheless, the process of communicating research results and recommendations to policy-making authorities involved critical debates between policy makers and researchers, among the researchers themselves and between the researchers and general practitioners, the speculative media reports on SP side-effects and reservations by the general public concerning the rationale for policy change, when to change, and to which drug of choice.
Changing national drug policy will remain a sensitive issue that cannot be done overnight. However, to ensure that research findings are recognised and the recommendations emanating from such findings are effectively utilized, a systematic involvement of all the key stakeholders (including policy-makers, drug manufacturers, media, practitioners and the general public) at all stages of research is crucial. It also matters how and when research information is communicated to the stakeholders. Professional organizations such as the East African Network on Malaria Treatment have potential to bring together malaria researchers, policy-makers and other stakeholders in the research-to-drug policy change interface.
研究是应对扩大干预措施规模和改善服务可及性挑战的重要工具。与许多其他国家一样,在坦桑尼亚,将研究证据转化为药物政策行动往往受到研究人员与政策决策者之间沟通不畅、个人对药物的认知或态度以及一些政策决策者在预期政策按提议变更可能产生不良影响时对批准变更的犹豫等因素的制约。在国际上,关于研究人员在国家抗疟药物政策变更中作用的文献有限。
描述(a)研究人员在提供影响坦桑尼亚政府将氯喹(CQ)替换为磺胺多辛 - 乙胺嘧啶(SP)作为一线药物的证据方面所起的作用,以及在说服政策制定者、全科医生、制药行业和公众认识到变革必要性方面所面临的挑战;(b)在坦桑尼亚引入新的联合药物治疗政策之前面临的挑战。
对国家级政策制定者、疟疾控制项目管理人员、药剂官员、全科医生、医学研究图书馆和出版官员、大学学者、医学研究机构负责人以及地区和区域医务官员进行了深入访谈。还通过审查疟疾药物政策文件获取了额外数据,并进行了参与观察。
2001年,坦桑尼亚政府正式更改了其疟疾治疗政策指南,长期以来作为一线药物的CQ被SP所取代。这一政策决定得到了研究证据的支持,该证据表明寄生虫对CQ产生了耐药性,与SP和阿莫地喹(AQ)相比,临床CQ治疗失败率已达到无法容忍的水平。研究还表明,由于SP也面临耐药性上升趋势,需要一种更有效的药物,但在过渡的5至10年期间,推荐相对比CQ和AQ更具成本效益的SP是合理的。政府在考虑到关于青蒿素联合疗法的治疗效果和成本效益的研究(已获得卫生部伦理批准)正在进行的情况下推出了政策变更。然而,将研究结果和建议传达给决策当局的过程涉及政策制定者与研究人员之间、研究人员自身之间以及研究人员与全科医生之间的激烈辩论,关于SP副作用的推测性媒体报道以及公众对政策变更的理由、何时变更以及选择何种药物的保留意见。
改变国家药物政策仍将是一个敏感问题,无法一蹴而就。然而,为确保研究结果得到认可并有效利用由此得出的建议,所有关键利益相关者(包括政策制定者、药品制造商、媒体、从业者和公众)在研究的各个阶段进行系统参与至关重要。研究信息传达给利益相关者的方式和时间也很重要。诸如东非疟疾治疗网络等专业组织有潜力将疟疾研究人员、政策制定者和研究 - 药物政策变更界面中的其他利益相关者聚集在一起。