Underreporting of suspected adverse drug reactions to newly marketed ("black triangle") drugs in general practice: observational study
Underreporting of suspected adverse drug reactions to newly marketed ("black triangle") drugs in general practice: observational study
复制标题
DOI：
10.1136/bmj.317.7151.119
复制
发表时间：
1998-07-11
影响因子：
--
通讯作者：
Mann, RD
中科院分区：
文献类型：
--
作者：
Martin, RM;Kapoor, KV;Mann, RD
关于新上市药物副作用的数据有限，1这突出表明需要进行有效的上市后监测。一个倒黑色三角形（.）在产品资料上识别新产品。对这些药物的可疑不良反应，无论多么轻微，都应通过黄牌计划向药品安全委员会报告。2不良反应被低估，3在英国很少有医生知道“黑三角”符号的含义。4我们评估了一般实践中新药可疑不良反应的漏报程度，并确定当反应严重或以前未被识别时报告是否不同。
Data on side effects of newly launched drugs are limited, 1 highlighting the need for effective postmarketing surveillance. An inverted black triangle (.) on product literature identifies new products. Suspected adverse reactions to these drugs, however minor, should be reported to the Committee on Safety of Medicines through the yellow card scheme. 2 Adverse reactions are underreported, 3 and few doctors in the United Kingdom know the meaning of the “black triangle” symbol. 4 We assessed the degree of underreporting of suspected adverse reactions to new drugs in general practice and determined if reporting varied when reactions were severe or previously unrecognised.