Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, India.
Hospital Administration & Management, Yashoda Super Speciality Hospital, Ghaziabad, India.
Front Public Health. 2022 Aug 11;10:930696. doi: 10.3389/fpubh.2022.930696. eCollection 2022.
Adverse drug reactions (ADRs) are major concerns to the public health. To monitor ADRs and ensure patients' safety, the Pharmacovigilance Programme of India (PvPI) has been established by the Government of India in 2010. The programme is intact with the Public-Private Partnership (3Ps) in pharmacovigilance for quality services, better management of human resources and risk minimization. The present work is aimed at assessing the 3Ps engagement, performance and tangible outcomes in PvPI and also mapping of resources. The study was carried out for the period of 2011 to 2021 by assessing the various benchmarking tools such as 3Ps categorization, utilization of ADRs reporting tools, trainings, and the Individual Case Safety Reports' (ICSRs) quantity, quality and transmission for regulatory intervention (RI). Under PvPI, Central or State Government medical institutions/hospitals and public health programmes constitute public partners while private medical institutions/hospitals, pharmaceutical companies, corporate hospitals and professional bodies account for private partners. We observed that public partners extensively used ADR reporting form and toll-free helpline number while private partners used mobile based app and emails/post as preferred tools for reporting ADRs. Contribution of public sector in training programmes organized, stakeholders trained and sharing of resource materials was way higher than the private sector. The study revealed that 55.1 and 44.9% ICSRs were received from public and private partners, respectively during the study period. The quality completeness of data received from public partners was found to be 0.92/1 as compared to 0.46/1 from the private partners. The ICSRs data transmitted for RI process from the public and private partners (till 2018) was found to be 79 and 21%, respectively. In terms of sharing of resources for training and capacity building, the public sector played a major role. The 3Ps in India are enabled to establish a robust system for medicines' safety surveillance; however a more focused approach is required in mapping the resources.
药物不良反应（ADR）是公众健康的主要关注点。为了监测 ADR 并确保患者安全，印度政府于 2010 年成立了印度药物警戒计划（PvPI）。该计划与药物警戒中的公私合作伙伴关系（3Ps）相结合，以提供高质量的服务、更好地管理人力资源和降低风险。本工作旨在评估 PvPI 中 3Ps 的参与度、绩效和有形成果，并对资源进行映射。该研究于 2011 年至 2021 年期间进行，通过评估各种基准工具，如 3Ps 分类、ADR 报告工具的利用、培训以及监管干预（RI）所需的个体病例安全报告（ICSR）的数量、质量和传输来进行。在 PvPI 下，中央或州政府医疗机构/医院和公共卫生计划构成公共合作伙伴，而私立医疗机构/医院、制药公司、企业医院和专业机构则构成私人合作伙伴。我们观察到，公共合作伙伴广泛使用 ADR 报告表和免费热线电话号码，而私人合作伙伴则使用移动应用程序和电子邮件/邮件作为报告 ADR 的首选工具。在培训计划组织、培训利益相关者和资源材料共享方面，公共部门的贡献远远高于私营部门。研究表明，在研究期间，分别有 55.1%和 44.9%的 ICSR 来自公共和私人合作伙伴。与私人合作伙伴的 0.46/1 相比，公共合作伙伴收到的数据完整性质量为 0.92/1。从公共和私人合作伙伴（截至 2018 年）为 RI 过程传输的 ICSR 数据分别为 79%和 21%。在培训和能力建设资源共享方面，公共部门发挥了重要作用。印度的 3Ps 能够为药品安全监测建立一个强大的系统；然而，在资源映射方面需要采取更有针对性的方法。
