Monash Institute of Pharmaceutical Sciences, Monash University, Melbourne, Victoria, Australia.
MERQ Consultancy PLC, Addis Ababa, Ethiopia; School of Public Health, Haramaya University, Harar, Ethiopia.
Res Social Adm Pharm. 2020 Apr;16(4):535-543. doi: 10.1016/j.sapharm.2019.07.011. Epub 2019 Jul 20.
The launch of novel pharmaceuticals in the developing world faces significant barriers that can delay or ultimately inhibit uptake. Implementation research can provide an understanding of factors influencing the introduction and scale up of a new product and thus can inform implementation strategy development.
This study explored the factors likely to influence introduction of a novel oxytocin formulation for the prevention of postpartum hemorrhage in Ethiopia.
Qualitative research methods were used to assess barriers and enablers associated with pre-determined domains: regulatory approval, pricing, supply and demand side advocacy, policy inclusion, end-user training and drug supply. Data were collected through focus group discussions and in-depth interviews with community members, healthcare providers and key informants. Verbatim transcripts were translated to English and analyzed using a thematic content framework.
Approval from stringent regulatory bodies was an enabler for gaining national regulatory approval. Purchasers (government and patients) expressed price sensitivity but would be willing to pay a price comparable to or higher than current alternatives if improved quality is delivered. Endorsement from the World Health Organization was described as critical for national policy inclusion. Supply side advocacy should be directed towards the Ministry of Health, which is receptive to advice from reputable agencies with whom they have an existing relationship. Demand side advocacy should be delivered through existing health system channels such as Ministry of Health authorities (for healthcare workers) and community health workers (for community members). The requirement to purchase the product directly from a single manufacturer was highlighted as a potential barrier for entry into the local supply chain.
This study highlighted several barriers and enablers associated with the introduction of a new drug product into the health system of Ethiopia. An advanced understanding of these influences can inform the design of locally-appropriate implementation strategies.
在发展中国家推出新药品面临着重大障碍，这些障碍可能会延迟或最终阻碍药品的采用。实施研究可以了解影响新产品引入和扩大规模的因素，从而为实施策略的制定提供信息。
本研究旨在探讨可能影响新型催产素制剂在埃塞俄比亚用于预防产后出血的引入的因素。
采用定性研究方法评估与预先确定的领域相关的障碍和促进因素：监管批准、定价、供需方倡导、政策纳入、最终用户培训和药品供应。通过焦点小组讨论和深入访谈收集社区成员、医疗保健提供者和关键信息者的数据。逐字记录被翻译成英文，并使用主题内容框架进行分析。
严格监管机构的批准是获得国家监管批准的促进因素。采购方（政府和患者）表示对价格敏感，但如果提供更高质量的产品，他们愿意支付与现有替代品相当或更高的价格。世界卫生组织的认可被描述为国家政策纳入的关键。供应方的倡导应针对卫生部，卫生部愿意接受与其有现有关系的信誉良好的机构的建议。需求方的倡导应通过现有的卫生系统渠道进行，如卫生部当局（针对医疗保健工作者）和社区卫生工作者（针对社区成员）。需要直接从单一制造商购买产品被强调为进入当地供应链的潜在障碍。
本研究强调了与将新药产品引入埃塞俄比亚卫生系统相关的几个障碍和促进因素。深入了解这些影响因素可以为制定适合当地情况的实施策略提供信息。
