The Max Foundation, 200 NW Pacific St, Suite 103, Seattle, WA, 98105, USA.
Global Medicines Program, Schools of Pharmacy and Public Health, University of Washington, BOX 357631, Seattle, WA, 98195-7631, USA.
Global Health. 2018 Jul 27;14(1):76. doi: 10.1186/s12992-018-0391-4.
Cancer is a major burden of disease in low- and middle-income countries (LMICs) yet financial barriers limit access to life-saving oncology drugs. Medical donation and other drug access programs can help improve patient access to essential medicines, such as quality assured oncology drugs in LMICs. However, there are no published examples of the conduct of pharmacovigilance with donated medical products intended for use in LMICs where pharmacovigilance is weak. We describe a partnership between a pharmaceutical company and a non-governmental organization as a case example that addresses the challenges in performing pharmacovigilance with donated medicines in LMICs. The Max Foundation's direct to patient model is designed to improve global access to quality assured oncology drugs through access programs such as the Glivec® (generic name: imatinib) International Patient Assistance Program (GIPAP).
Between 2013 and 2016, in the course of managing the GIPAP program, The Max Foundation was made aware of 13,039 instances of adverse events (AEs). These AEs were reported to The Max Foundation by physicians, patients, and caregivers. The Max Foundation reported these AEs to Novartis through the AE reporting tool within its Patient Assistance Tracking System (PATS). Physicians were the reporters for 58% of the AEs while the remainder of the AEs were reported directly by patients or caregivers. The overall rate of reported AEs remained relatively steady for the years 2013 through 2016 at 92, 95, 86, and 97 AEs reported per 1000 persons who received Glivec® per year, respectively. The vast majority of adverse events (85%) were reported from countries where The Max Foundation has a MaxStation, i.e., where The Max Foundation staff interact directly with physicians and patients at clinics or over the phone. AE reporting rates were consistently higher in all years studied from countries where The Max Foundation has a MaxStation. While India accounted for the largest number of reported adverse events in 2016 (1990), Bolivia had the highest rate of reported adverse events at 484 AEs per 1000 patients.
International patient assistance programs that provide access to medicines can have an important role in assisting pharmaceutical companies in fulfilling their pharmacovigilance obligations. Adverse event information collected through PATS can potentially contribute to the overall body of knowledge on the safety of medicinal products.
癌症是中低收入国家（LMICs）的主要疾病负担，但经济障碍限制了挽救生命的肿瘤药物的可及性。医疗捐赠和其他药物获取计划有助于改善患者获得基本药物的机会，例如在 LMICs 中获得质量有保证的肿瘤药物。然而，在药物警戒薄弱的情况下，没有关于对捐赠给 LMICs 的医疗产品进行药物警戒的已发表示例。我们描述了一家制药公司和一家非政府组织之间的合作伙伴关系，作为一个案例，说明了在药物警戒薄弱的情况下，用捐赠药品进行药物警戒所面临的挑战。Max 基金会的直接面向患者模式旨在通过 Glivec®（通用名：伊马替尼）国际患者援助计划（GIPAP）等获取计划来改善全球获得质量有保证的肿瘤药物的机会。
在 2013 年至 2016 年期间，在管理 GIPAP 计划的过程中，Max 基金会注意到 13039 例不良事件（AE）。这些 AE 是由医生、患者和护理人员向 Max 基金会报告的。Max 基金会通过其患者援助跟踪系统（PATS）中的 AE 报告工具向诺华报告这些 AE。医生是 58%的 AE 报告人，其余 AE 由患者或护理人员直接报告。2013 年至 2016 年期间，每年接受 Glivec®治疗的 1000 人中，报告的 AE 分别为 92、95、86 和 97 例，报告的 AE 总体率相对稳定。绝大多数不良事件（85%）来自 Max 基金会设有 MaxStation 的国家，即 Max 基金会工作人员在诊所或通过电话与医生和患者直接互动的国家。在所有研究年份中，AE 报告率均高于设有 MaxStation 的国家。虽然印度在 2016 年报告的不良事件数量最多（1990 例），但玻利维亚的报告不良事件率最高，为每 1000 名患者 484 例。
提供药物获取机会的国际患者援助计划可以在协助制药公司履行药物警戒义务方面发挥重要作用。通过 PATS 收集的不良事件信息有可能为药物安全性的整体知识体系做出贡献。
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