Off-label drug use in human immunodeficiency virus disease.
Off-label drug use in human immunodeficiency virus disease.
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人类免疫缺陷病毒疾病中的超说明书用药。
DOI：
10.1097/00042560-199605010-00008
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发表时间：
1996
期刊：
影响因子：
--
通讯作者：
D. Abrams
中科院分区：
文献类型：
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作者：
C. Brosgart;T. Mitchell;E. Charlebois;R. Coleman;S. Mehalko;Jamie Young;D. Abrams
我们希望确定用于治疗HIV疾病及其临床表现的药物在多大程度上适用于美国食品和药物管理局(FDA)批准的药品标签上列出的情况，这种“标签外”使用如何随患者特征和HIV相关医疗状况的类型而变化，以及医生因标签外药物使用相关的报销问题而改变他们治疗HIV相关疾病的方式的程度。1993年2月至5月期间，我们调查了1530名艾滋病毒携带者的初级保健提供者。使用一个由三部分组成的调查工具来获得数据，其中包括提供者为最后三名艾滋病毒患者开的药物、对32种特定艾滋病毒相关疾病的首选治疗方案，以及提供者在使用非标签适应症药物时面临报销问题的程度。使用了三种药品汇编作为标签外药物使用的引用来源。总共返回了387项(32%)可评估调查，产生了1148名患者的数据。大多数患者(81%)接受了至少一种标签外的药物治疗，几乎一半(40%)的报告药物治疗是标签外的。大多数非标签药物用于治疗和预防艾滋病毒相关的机会性感染，这往往代表着社区的做法标准(例如，用于预防卡氏肺孢子虫肺炎的甲氧嘧啶/磺胺甲恶唑)，或在没有获得许可的治疗方法的情况下的事实上的做法标准(例如，治疗禽型分枝杆菌复合体的药物)。超过75%的非标签用法至少在三个权威医学汇编中的一个中被引用。在艾滋病毒护理中将药物用于非标签适应症是很常见的，并且经常代表社区护理标准。尽管由于药典出版滞后，许多合法的非标签药物使用可能不包括在内，但大多数此类用途都依赖于药物汇编来支持非标签药物的使用。常规临床实践中标签外药物使用的普遍情况以及用于治疗艾滋病毒及其医疗并发症的更新和更昂贵的药物的开发表明，应明确规定处方药标签外使用的国家补偿政策，以便以合理、一致的方式向有保险的人提供医疗适当的治疗。
We wished to determine the extent to which drugs used to treat HIV disease and its clinical manifestations are prescribed for conditions other than those listed on the U.S. Food and Drug Administration's approved drug label, how such "off-label" use varies by patient characteristics and type of HIV-related medical condition, and the extent to which physicians alter the way they treat HIV-related conditions because of reimbursement problems associated with off-label drug use. We surveyed 1,530 primary care providers for people with HIV disease between February and May 1993. A three-part survey instrument was used to obtain data on the drugs prescribed for the last three patients with HIV disease treated by the provider, the preferred choice of therapy for 32 specific HIV-related conditions, and the extent to which providers faced reimbursement problems regarding the use of drugs for off-label indications. Three drug compendia were used as cited sources of off-label drug uses. In all, 387 (32%) evaluable surveys were returned, yielding data on 1,148 patients. The majority (81%) of patients received at least one drug off-label, and almost half (40%) of all reported drug therapy was off-label. Most off-label drug use was for treatment and prevention of HIV-related opportunistic infections, which frequently represented the community standard of practice (e.g., trimethoprim/sulfamethoxazole for prevention of Pneumocystis carinii pneumonia), or the de facto standard of practice when no licensed therapies were available (e.g., drugs for treatment of Mycobacterium avium complex, MAC). More than 75% of off-label usage was cited in at least one of the three authoritative medical compendia. The use of drugs for off-label indications in HIV care is common and frequently represents community standards of care. Reliance on drug compendia for support of off-label drug use accounts for the majority of such uses, although many legitimate off-label uses may not be included because of compendia publication lag. The prevalence of off-label drug use in routine clinical practice and the development of newer and more costly drugs for treatment of HIV and its medical complications argues for the articulation of an explicit national reimbursement policy for off-label uses of prescription drugs so that medically appropriate therapies will be available to those with insurance in a rational, consistent way.