Giouroukakis Mary, Dryer Megan
Department of Pharmacy, Drug Information Center, NewYork-Presbyterian Hospital, Columbia University Medical Center, NewYork, NY 10032, USA.
J Pharm Pract. 2013 Apr;26(2):112-9. doi: 10.1177/0897190012474234. Epub 2013 Mar 4.
Pharmacists in all areas of practice frequently dispense or recommend drugs without realizing that some commonly used medications have never received Food and Drug Administration (FDA) approval. Most of these medications have been available for many years and are usually misconceived as generic drugs, when in fact they never went through the required quality, safety, and efficacy testing required by FDA. As a result, unapproved drugs can pose serious safety risks to patients and create uncertainty in the market. FDA established the "Unapproved Drugs Initiative" to protect public health by decreasing the number of available unapproved drugs with minimal disruptions to the market. Unapproved drugs remain in the market for various historical reasons. It is important for health care providers, particularly pharmacists, to be knowledgeable about unapproved products and consider switching patients to FDA-approved alternatives if possible when selecting drug therapy. Several resources are available on the FDA Website to determine approval status. Although FDA is working to remove unapproved drugs from the market, there will be circumstances when the use of unapproved drugs is medically necessary and appropriate. In these cases, pharmacists can monitor for and report adverse events and stay informed regarding any changes in approval status.
各个执业领域的药剂师在配药或推荐药物时，常常没有意识到某些常用药物从未获得美国食品药品监督管理局（FDA）的批准。这些药物大多已上市多年，通常被误以为是仿制药，而实际上它们从未经过FDA要求的质量、安全性和有效性测试。因此，未经批准的药物可能会给患者带来严重的安全风险，并在市场上造成不确定性。FDA设立了“未经批准药物倡议”，以通过减少市场上未经批准药物的数量，同时尽量减少对市场的干扰来保护公众健康。由于各种历史原因，未经批准的药物仍留在市场上。对于医疗保健提供者，尤其是药剂师来说，了解未经批准的产品非常重要，并且在选择药物治疗时，如果可能的话，应考虑让患者改用FDA批准的替代药物。FDA网站上有多种资源可用于确定批准状态。尽管FDA正在努力将未经批准的药物从市场上清除，但在某些情况下，使用未经批准的药物在医学上是必要且合适的。在这些情况下，药剂师可以监测并报告不良事件，并随时了解批准状态的任何变化。
