NEJM：霍奇金淋巴瘤患儿药物短缺不容小觑
2013-01-11 NEJM medlive
在过去数年中，患者和医疗保健提供者所面临的药物缺口越来越大，特别是仿制注射药剂更是如此。药物短缺的原因是复杂的。非专利药物狭小的利润空间使其生产鲜有人问津。其它的因素还包括药企的数量有限，全球范围的需求增加，原材料的短缺，生产的难题，生产车间老化，库存以及审批的漫长时间等等。随之而来的是患者得不到有效的治疗：从候选药物中选择处方药，但替补药物可
在过去数年中，患者和医疗保健提供者所面临的药物缺口越来越大，特别是仿制注射药剂更是如此。药物短缺的原因是复杂的。非专利药物狭小的利润空间使其生产鲜有人问津。其它的因素还包括药企的数量有限，全球范围的需求增加，原材料的短缺，生产的难题，生产车间老化，库存以及审批的漫长时间等等。随之而来的是患者得不到有效的治疗：从候选药物中选择处方药，但替补药物可能效用不理想，或毒性太大，价格昂贵，或以上不足兼而有之，如果医师不了解候选药剂的性质，安全性就会成为问题。
抗肿瘤药物的缺乏可能更棘手，因为可能缺乏等效的药物，替代药品及其剂量的调整也需摸索。近来媒体强调阿糖胞苷，柔红霉素，以及甲氨喋呤等儿童白血病药物急缺，而这种疾病的治愈率极高。幸运的是，此次急缺得以迅速地解决。备选的策略有很多，诸如对适应此类药物的患者进行优先级排序，应用等效的候选药物以弥补药物空缺等。
两种治疗方案儿童霍奇金淋巴瘤患者的无事件生存率分布曲线
Over the past several years, patients and caregivers have faced an increasing number of drug shortages, predominantly of generic injectable agents. The reasons for these shortages are complex. Narrow profit margins for generic drugs have limited the incentive to produce them. Other reasons include the limited number of manufacturers, increased worldwide demand, shortages of raw materials, production problems, aging production plants, stockpiling, and long timelines for approval.1 Patient care may suffer significantly as a result: alternative drugs must be prescribed, but the replacement may be less efficacious, more toxic, prohibitively expensive, or all of the above, and safety may be compromised if providers are unfamiliar with administering the substitute.
Shortages of anticancer agents are even more critical, because there may be no equivalents for the drugs that are in short supply, and conversion factors and dose adjustments may be unknown. Recent media coverage has highlighted shortages of cytarabine, daunorubicin, and methotrexate, which are essential for treating childhood leukemia, a highly curable cancer. Fortunately, those shortages were quickly resolved, and alternative strategies such as prioritizing patients for access to certain drugs and using equivalent agents sufficed to bridge the gap....
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