Project Covima: A reclassification application to widen access to a medicine that enables pharmacy to support a major public health need, where services are massively disrupted by C19, with significant societal impact

Project Covima：一个重新分类的应用程序，旨在扩大药物的获取范围，使药房能够支持主要的公共卫生需求，其中服务受到 C19 的严重干扰，具有重大的社会影响

• 批准号: 69467
• 金额: $ 9.52万
• 依托单位: MAXWELLIA LTD
• 依托单位国家: 英国
• 项目类别: Feasibility Studies
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=69467
• 关键词: Project; Covima; reclassification; application; widen

* Helping pharmacists to plug the void in contraceptive services that has resulted as an outcome of the C19 pandemic where access to GP's and sexual health clinics has been severely disrupted with some services suspended altogether. The effect of C19 on the unborn child is currently unknown.* Maxwellia aims to submit a reclassification application to widen access to an oral contraceptive pill to make it available for women to buy in a pharmacy without the need for a doctor's prescription.* This involves:1. The design of a realistic and deliverable pharmacy supply model2. Procurement of a suitable marketing authorisation from a contract manufacturer3. Designing and preparing the key components of the reclassification application for the drug4. Submitting the application to reclassify the drug to the UK regulator (MHRA)5. Addressing MHRA concerns to overcome them6. Managing the process to its successful conclusion.* This will enable more women to access contraceptive services more easily and save money for the NHS by potentially reducing the GP appointments needed to service the 3.3 million prescriptions that are issued for this type of drug each year at an estimated cost of £99m.* Project Covima will help reduce unplanned pregnancy which currently costs the NHS £240m per annum and is set to rise due to C19 where a baby boom (the coronials) is predicted as a result of C19, adding further pressure to the NHS with resultant increased costs for the nation.-Additional information - The extension for impact funding will allow Maxwellia to conduct a study reviewing the success and acceptability of Maxwellia’s first contraceptive product in pharmacy and the effectiveness of the pharmacy training materials to support the MHRA reclassification application.

* 帮助药剂师填补避孕服务的空白，这是由于C19大流行造成的，在这种情况下，全科医生和性健康诊所的服务受到严重干扰，一些服务完全暂停。C19对胎儿的影响目前尚不清楚。Maxwellia的目标是提交一份重新分类申请，以扩大口服避孕药的使用范围，使妇女无需医生处方就可以在药店购买。这包括：1.一个现实的和可交付的药房供应模型的设计2.从合同制造商处获得合适的营销授权3。设计和准备药物重新分类申请的关键组成部分4.向英国监管机构（MHRA）提交重新分类药物的申请5.解决MHRA关注的问题，以克服它们6.管理进程直至圆满结束。*这将使更多的妇女能够更容易地获得避孕服务，并通过可能减少每年为此类药物开出的330万张处方所需的全科医生预约来为NHS节省资金，估计费用为9900万英镑。Covima项目将有助于减少计划外怀孕，目前NHS每年花费2.4亿英镑，并且由于C19预计婴儿潮（冠状动脉）将上升，这将进一步增加NHS的压力，从而增加国家的成本。额外信息-延长影响资金将允许Maxwellia进行一项研究，审查Maxwellia的第一个避孕产品在药房的成功和可接受性，以及药房培训材料的有效性，以支持MHRA重新分类申请。