Marshall Health, Huntington, WV.
VA Pharmacy Benefits Management Services, Washington, DC.
Am J Health Syst Pharm. 2019 Nov 13;76(23):1934-1943. doi: 10.1093/ajhp/zxz227.
Many medications that were marketed prior to 1962 but lack Food and Drug Administration (FDA) approval are prescribed in the United States. Usage patterns of these "unapproved medications" are poorly elucidated, which is concerning due to potential lack of data on safety and efficacy. The purpose of this project was to characterize purchases of unapproved medications within the Veterans Health Administration (VHA) by type, frequency, and cost.
VHA purchasing databases were used to create a list of all products with National Drug Codes (NDCs) purchased nationwide in fiscal year 2016 (FY16). This list was compared to FDA databases to identify unapproved prescription medications. For each identified combination of active pharmaceutical ingredient (API) and route of administration ("API/route combination"), numbers of packages purchased and associated costs were added.
VHA pharmacy purchasing records contained 3,299 unapproved products with NDCs in FY16. After excluding equipment, nutrition products, compounding ingredients, nonmedication products, and duplicate NDCs, there were 600 unique NDCs associated with 130 distinct API/route combinations. The most commonly acquired product was prescription sodium fluoride dental paste (350,775 packages). The greatest pharmaceutical expenditure was for sodium hyaluronate injection ($24.5 million). Unapproved products accounted for less than 1% of overall VHA pharmacy purchasing in FY16.
VHA purchased many unapproved prescription products in FY16 but is taking action to address use of such products in consideration of safety and efficacy data and available alternatives.
许多在 1962 年之前销售但缺乏美国食品和药物管理局 (FDA) 批准的药物仍在美国开处方。这些“未经批准的药物”的使用模式尚未得到充分阐明，这令人担忧，因为可能缺乏关于安全性和疗效的数据。本项目的目的是描述退伍军人健康管理局 (VHA) 中未经批准药物的购买类型、频率和成本。
使用 VHA 采购数据库创建了一份 2016 财年 (FY16) 全国范围内购买的带有国家药品代码 (NDC) 的所有产品的清单。将此清单与 FDA 数据库进行比较，以确定未经批准的处方药物。对于每个识别出的活性药物成分 (API) 和给药途径 ("API/route combination")，将购买的包装数量和相关成本相加。
VHA 药房采购记录包含 3299 种带有 NDC 的未经批准产品 FY16。在排除设备、营养产品、配方成分、非药物产品和重复的 NDC 后，有 600 个唯一的 NDC 与 130 个独特的 API/route 组合相关联。最常购买的产品是处方氟化钠牙膏 (350775 支)。最大的药物支出是透明质酸钠注射液 (2450 万美元)。未经批准的产品在 FY16 中占 VHA 药房采购总额的不到 1%。
VHA 在 FY16 购买了许多未经批准的处方产品，但正在采取行动，考虑到安全性和疗效数据以及可用替代品，解决此类产品的使用问题。
