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英国执业医师药品不良反应报告态度调查

Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom.

作者信息

Belton K J, Lewis S C, Payne S, Rawlins M D, Wood S M

机构信息

Wolfson Unit of Clinical Pharmacology, University of Newcastle upon Tyne.

出版信息

Br J Clin Pharmacol. 1995 Mar;39(3):223-6. doi: 10.1111/j.1365-2125.1995.tb04440.x.

Abstract
  1. Attitudes of doctors to the Committee on Safety of Medicines' (CSM) adverse drug reaction (ADR) reporting scheme were investigated in order to assess their understanding of the purposes of the scheme and to identify reasons for failing to report suspected adverse drug reactions. 2. A postal questionnaire and letter of invitation were sent to 500 doctors who were randomly selected from the 1992 Medical Directory. A reminder letter and a second copy of the questionnaire were sent to non-responders after 4 weeks. 3. 284 (57%) responded to the questionnaire. Of these, 179 (63%) stated that they had previously reported an ADR to the CSM or a pharmaceutical manufacturer. 77% of general practitioners stated that they had reported one or more ADRs compared with 55% of hospital doctors. 4. Reasons for under-reporting included lack of time, lack of report forms and the misconception that absolute confidence in the diagnosis of an adverse reaction was important in the decision to send in a report. 5. An investigation of seven commonly proposed reasons for under-reporting showed that on the whole they did not apply. 6. Most doctors knew the types of reactions that the Committee on Safety of Medicines seeks reports for but only 38% knew the precise meaning of the Committee on Safety of Medicines' black triangle symbol. There also seemed to be confusion about some of the purposes of the adverse drug reaction reporting scheme. 7. The number of reporting doctors is much higher than has previously been estimated.(ABSTRACT TRUNCATED AT 250 WORDS)
摘要
  1. 对医生们关于药品安全委员会(CSM)药品不良反应(ADR)报告计划的态度展开调查,以评估他们对该计划目的的理解,并找出未能报告疑似药品不良反应的原因。2. 向从1992年《医学名录》中随机抽取的500名医生发送了邮政调查问卷和邀请函。4周后,向未回复者发送了催复信和问卷的第二份副本。3. 284名(57%)医生回复了问卷。其中,179名(63%)表示他们之前曾向CSM或药品制造商报告过药品不良反应。77%的全科医生表示他们曾报告过一种或多种药品不良反应,相比之下,医院医生的这一比例为55%。4. 报告不足的原因包括时间不足、缺乏报告表格,以及存在一种误解,即对不良反应诊断的绝对把握在决定提交报告时很重要。5. 对七个常见的报告不足原因进行的调查表明,总体而言这些原因并不适用。6. 大多数医生知道药品安全委员会希望收到报告的不良反应类型,但只有38%的医生知道药品安全委员会黑色三角符号的确切含义。对于药品不良反应报告计划的一些目的似乎也存在困惑。7. 报告的医生数量比之前估计的要多得多。(摘要截选至250词)

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