Almeter Philip J, Isaacs James T, Hunter Aaron N, Henderson Bradley S, Platt Thomas, Mitchell Billie J, Do David, Brainard Alyssa B, Brown Joshua E, Stone Rachael M, Nguyen Bao-Han, Warren Matthew F, Bhaktawara Smaran A, Bossle Megan N, Long Lindsey M, Zapata Stephanie P, Larkin Cinnamon R, Lyman Thomas A, Larkin Seth A, Labuhn Jonathan A, Reynolds Jeffrey W, Schuler Erin E, Naseman Ryan W, Johnson Gary L, Lodder Robert A
Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY USA.
Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY USA.
J Pharm Innov. 2022;17(2):269-282. doi: 10.1007/s12247-022-09659-5. Epub 2022 Jun 3.
Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing practices roughly 60 years ago, forces related to the global economy have changed, rendering the task of monitoring quality more difficult. Alternative strategies by groups like Valisure, LLC, and the University of Kentucky Drug Quality Study to monitor the quality of the currently circulated US drug supply through end-product testing and screening have resulted in several concerning findings. Given the successful approaches of identifying quality defects in pharmaceuticals by non-regulatory bodies, and considering the changing landscape and pressures on manufacturing, the FDA, large buying groups, and the US Department of Defense should consider these alternative strategies as a means to augment current regulatory activities.
大约60年前，美国食品药品监督管理局（FDA）开始通过实施现行药品生产质量管理规范来监测药品生产质量，自那时起，与全球经济相关的各种力量发生了变化，使得质量监测任务变得更加困难。像Valisure有限责任公司和肯塔基大学药品质量研究小组等组织，通过成品检测和筛查来监测美国当前流通药品供应质量的替代策略，已经得出了一些令人担忧的结果。鉴于非监管机构在识别药品质量缺陷方面的成功方法，同时考虑到制药行业不断变化的形势和生产压力，FDA、大型采购集团和美国国防部应将这些替代策略视为增强当前监管活动的一种手段。
