Potential risks of pharmacy compounding.
Potential risks of pharmacy compounding.
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DOI：
10.1007/s40268-013-0005-9
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发表时间：
2013-03
期刊：
影响因子：
3
通讯作者：
Randell M
中科院分区：
文献类型：
--
作者：
Gudeman J;Jozwiakowski M;Chollet J;Randell M
药物配制涉及为具有特殊医疗需求的个体患者制备商业上无法买到的定制药物。当药剂师根据个人处方小规模配制药物时，传统的药剂配制是合适的。然而，对药物制剂的监管远不如美国食品和药物管理局 (FDA) 批准的药物要求严格；因此，复合药物可能会给患者带来额外的风险。 FDA 批准的药物是根据良好生产规范 (GMP) 进行制造和测试的，这些法规是管理药品生产和测试的联邦法规。相比之下，复合药物不受 GMP 约束，评估产品质量的测试也不一致。与 FDA 批准的药物不同，药物复合产品的安全性或有效性并未经过临床评估。此外，复合制剂没有标准的产品标签或处方信息以及安全使用说明。复合药房不需要向 FDA 报告不良事件，这对于 FDA 监管的药物制造商来说是强制性的。一些药房从事的活动超出了传统药房配制的范围，例如在没有个别患者处方的情况下大规模生产配制药物、配制尚未在美国批准使用的药物以及创建 FDA 批准的药物的副本。在没有 GMP 的情况下配制药物会增加制备错误的可能性。当大规模进行复合时，此类错误可能会对许多患者产生不利影响。 FDA、国家机构和其他机构发布的独立测试报告一致表明，复合药物不符合规格的比例远高于 FDA 批准的药物。复合无菌制剂给患者带来了微生物污染的额外风险。在过去 11 年里，三起不同的脑膜炎疫情都被追溯到由复合药房生产的据称被真菌或细菌污染的“无菌”类固醇注射剂。最近 2012 年的疫情爆发导致人们对药房配制操作进行严格审查，并越来越多地认识到需要确保配制仅限于适当的情况。患者和医疗保健从业人员需要意识到，复方药物与 FDA 批准的仿制药不同。使用传统复合药物的风险效益比对于需要非市售特殊药物的患者是有利的，因为否则他们将无法获得适当的治疗。然而，如果 FDA 批准的药物已上市，使用未经批准的复合药物会带来额外的风险，但不会带来相应的益处。
Pharmacy compounding involves the preparation of customized medications that are not commercially available for individual patients with specialized medical needs. Traditional pharmacy compounding is appropriate when done on a small scale by pharmacists who prepare the medication based on an individual prescription. However, the regulatory oversight of pharmacy compounding is significantly less rigorous than that required for Food and Drug Administration (FDA)-approved drugs; as such, compounded drugs may pose additional risks to patients. FDA-approved drugs are made and tested in accordance with good manufacturing practice regulations (GMPs), which are federal statutes that govern the production and testing of pharmaceutical products. In contrast, compounded drugs are exempt from GMPs, and testing to assess product quality is inconsistent. Unlike FDA-approved drugs, pharmacy-compounded products are not clinically evaluated for safety or efficacy. In addition, compounded preparations do not have standard product labeling or prescribing information with instructions for safe use. Compounding pharmacies are not required to report adverse events to the FDA, which is mandatory for manufacturers of FDA-regulated medications. Some pharmacies engage in activities that extend beyond the boundaries of traditional pharmacy compounding, such as large-scale production of compounded medications without individual patient prescriptions, compounding drugs that have not been approved for use in the US, and creating copies of FDA-approved drugs. Compounding drugs in the absence of GMPs increases the potential for preparation errors. When compounding is performed on a large scale, such errors may adversely affect many patients. Published reports of independent testing by the FDA, state agencies, and others consistently show that compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs. Compounded sterile preparations pose the additional risk of microbial contamination to patients. In the last 11 years, three separate meningitis outbreaks have been traced to purportedly ‘sterile’ steroid injections contaminated with fungus or bacteria, which were made by compounding pharmacies. The most recent 2012 outbreak has resulted in intense scrutiny of pharmacy compounding practices and increased recognition of the need to ensure that compounding is limited to appropriate circumstances. Patients and healthcare practitioners need to be aware that compounded drugs are not the same as generic drugs, which are approved by the FDA. The risk-benefit ratio of using traditionally compounded medicines is favorable for patients who require specialized medications that are not commercially available, as they would otherwise not have access to suitable treatment. However, if an FDA-approved drug is commercially available, the use of an unapproved compounded drug confers additional risk with no commensurate benefit.