Pearson K
Hosp Pharm. 1982 Aug;17(8):421-2, 427-30.
During premarketing trials, the number of patients exposed to a drug and the length of exposure to a drug are both limited. After marketing, many thousands, frequently millions, of patients are exposed to the drug over considerably longer periods of time, and adverse drug reactions not previously recognized appear. Because of these factors, postmarketing surveillance is extremely important. Pharmacists can contribute to drug safety and improved patient care by understanding and actively participating in the Food and Drug Administration's Spontaneous Reporting Program.
在上市前试验期间,接触药物的患者数量和接触药物的时间长度都受到限制。上市后,成千上万、通常是数百万的患者会在相当长的时间内接触该药物,从而出现以前未被识别的药物不良反应。由于这些因素,上市后监测极为重要。药剂师可以通过了解并积极参与美国食品药品监督管理局的自发报告计划,为药物安全和改善患者护理做出贡献。