Addressing conflict of interest driving irrational prescribing of antibiotics in pluralistic health systems: an interventional study in Pakistan

本文提出的研究应用尖端的卫生政策和系统研究来解决一个关键的和未得到充分解决的全球卫生挑战：利益冲突（COI）阻碍了私营医疗保健提供者提供的护理质量的提高。我们将COI定义为一种情况，即医疗保健提供者判断的公正性可能受到次要利益（如经济利益）的影响，从而导致做出不符合患者最佳利益的决定。有强有力的证据表明，寻求从患者咨询中获利的私人医生经常会遇到COI，导致开出不必要的药物或诊断测试，或者比现有的替代方案更昂贵。我们重点关注巴基斯坦私人医生的不合理抗生素处方。巴基斯坦是世界上人口第六多的国家，80%以上的人首先向私人医生寻求治疗，而且该国的抗生素使用率是世界上最高的。在巴基斯坦和其他低收入和中等收入国家进行的研究，包括我们自己早期的研究，表明私人医生为了从制药公司获得利益或从药品销售中获利，在病人不需要抗生素的情况下开出多种抗生素。尽管这一问题的规模和紧迫性影响到数百万人，并导致可在世界各地蔓延的抗微生物药物耐药性，但关于在执行规则的资源和政治支持不足的情况下有效的战略的证据极其有限。因此，培训干预措施的重点是增加知识和技能，以影响私营提供者的自愿行为改变，这是最常用的方法。然而，当不合理的处方主要是为了赚钱而不是缺乏知识时，这些干预措施的成功是有限的；在这里，与职业道德相关的规范和价值观对于采取干预措施至关重要。我们的研究有四个相互关联的目标，它们一起将产生新的证据，证明继续医学教育干预的影响，特别设计的信息使医生对职业道德和COI敏感，以及关于需要克服的障碍的关键见解，以促进在当地卫生系统中扩大这种干预。由于负责解决私人医生执业问题的有影响力的利益相关者本身可能会跨越职业道德界限，通常会有多种收入来源而不披露，因此我们的第一个目标是了解巴基斯坦有影响力的利益相关者如何将COI和职业道德概念化，以确定我们干预的潜在支持者和反对者。我们接下来关注的是私人医生，调查他们如何决定从开抗生素处方中获得个人利益，哪些是道德上不可接受的，哪些是可接受的。我们的第三个目标是了解如何最好地传达信息，使私人医生对职业道德敏感，以及利益冲突推动不合理抗生素处方的作用，以便设计我们的干预措施。我们的最终目标是评估我们的干预对私人医生的行为和态度的影响，这些行为和态度涉及到制药公司开出抗生素处方的不道德利益。拟议研究的一个关键优势是，它是与巴基斯坦的科学家和决策者共同设计的，建立在之前在巴基斯坦和柬埔寨由研究委员会资助的两个项目的基础上。除了提供新的证据，为改善护理质量和应对抗菌素耐药性的持续投资提供信息外，我们关于COI的医学教育材料可用于其他环境中的研究和培训，并且作为我们创新卫生系统研究方法的一部分开发的工具将用于未来的研究。

The study proposed here applies cutting-edge health policy and systems research to address a critical and poorly addressed global health challenge: conflict of interest (COI) hindering improvements in the quality of care delivered by private healthcare providers. We define COI as a situation whereby the impartiality of a healthcare provider's judgment may be influenced by a secondary interest, such as financial gain, leading to a decision that is not in the patient's best interest. There is strong evidence that private doctors seeking to make a profit from patient consultations often experience a COI resulting in prescription of medication or diagnostic tests that are either unnecessary or more costly than available alternatives. We focus on irrational prescribing of antibiotics by private doctors in Pakistan, the sixth most populous country in the world, where more than 80% of people first seek care at private doctors and where antibiotic usage is among the highest in the world. Studies in Pakistan and other low and middle income countries, including our own earlier research, show that private doctors prescribe multiple antibiotics when patients do not need them in order to receive benefits from pharmaceutical companies, or make profits from the medicine sales. Despite the scale and urgency of this issue, which affects millions of people and drives antimicrobial resistance which can spread across the world, there is extremely limited evidence on strategies that are effective in contexts where resources and political support for the enforcement of rules are low. Therefore, training interventions focusing on increasing knowledge and skills to affect voluntary behaviour change in private providers is the most common approach used. However, these interventions have had limited success when irrational prescribing is mainly motivated by profit-generation rather a lack of knowledge; here norms and values associated with professional ethics are critical to address with interventions.Our study has four linked objectives, which together will generate new evidence about the impact of a continuing medical education intervention with specially designed messages to sensitise doctors to professional ethics and COI, as well as critical insights about barriers that need to be overcome in order to facilitate scale-up of this intervention in the local health system. Since influential stakeholders responsible for addressing practices of private doctors may be crossing professional ethics boundaries themselves, often by having multiple income streams without disclosure, our first objective is to understand how COI and professional ethics is conceptualised by influential stakeholders in Pakistan in order to identify potential supporters and opponents of our intervention. We next focus on private doctors, investigating how they decide what is ethically unacceptable and acceptable with respect to getting personal benefits from prescribing antibiotics. Our third objective is to understand how best to present messages that sensitise private doctors to professional ethics and the role of conflict of interest driving irrational prescription of antibiotics in order to design our intervention. Our final objective is to assess the impact of our intervention on the behaviour and attitudes of private doctors with respect to unethical benefits from pharmaceutical companies for prescribing antibiotics.A key strength of the proposed study is that it has been co-designed with Pakistani researchers and policymakers, building on two previous research council funded projects in Pakistan and Cambodia. In addition to producing new evidence to inform ongoing investments in improving quality of care and tackling antimicrobial resistance, our medical education material on COI can be used for research and training in other settings, and the tools developed as part of our innovative health systems research methods will be made available for future studies.