Bäckström M, Mjörndal T, Dahlqvist R
Division of Clinical Pharmacology, University Hospital of Umeå Universitet S-901, 85 Umeå, Sweden.
Pharmacoepidemiol Drug Saf. 2002 Dec;11(8):647-50. doi: 10.1002/pds.753.
Spontaneous reporting of adverse drug reactions (ADRs) remains one of the most effective methods to detect new and serious drug reactions. However, it is well known that there is a high degree of under-reporting.
This study was carried out as an attempt to improve and increase the reporting of ADRs by investigating the utility of nurses reporting in addition to physicians, as usual.
During a 12-month study period, nurses working at two departments of geriatric medicine in northern Sweden received special instruction regarding drugs and ADRs, ADR reporting and special aspects of ADRs in elderly people. The reports from the nurses were scrutinized concerning the seriousness of the reaction, reported drugs and type of reaction (type A or B). All nurses working at the two departments (117) were eligible to report but in practice only those attending the teaching sessions did so. A comparison with historical reporting and with reporting from other geriatric departments in Sweden was also carried out. At the end of the study all participating nurses received a questionnaire aimed at investigating their attitudes towards ADR reporting.
After the 12-month study period 18 ADR reports involving 22 reactions had been received. Seven of these were assessed as serious reactions. All of the reactions were of type A. In comparison, during the corresponding time period from the study clinics during the preceding year, only two reports were registered. During the study period only 15 reports were registered from the other 50 geriatric departments in Sweden.
Even though the total number of ADR reports was small, our data indicate a substantial increase in the reporting rate. This indicates that instructed and interested nurses could play an important role in detecting and reporting suspected ADRs.
药物不良反应（ADR）的自发报告仍然是发现新的和严重药物反应的最有效方法之一。然而，众所周知，报告率很低。
本研究旨在通过调查护士报告（除医生常规报告外）的作用，来改进和增加ADR报告。
在为期12个月的研究期间，瑞典北部两个老年医学科的护士接受了关于药物和ADR、ADR报告以及老年人ADR特殊方面的特殊指导。对护士的报告进行审查，内容包括反应的严重性、报告的药物和反应类型（A型或B型）。两个科室的所有护士（117名）均有资格报告，但实际上只有参加培训课程的护士进行了报告。还与历史报告以及瑞典其他老年医学科的报告进行了比较。研究结束时，所有参与的护士都收到了一份问卷，旨在调查他们对ADR报告的态度。
在为期12个月的研究期后，共收到18份ADR报告，涉及22例反应。其中7例被评估为严重反应。所有反应均为A型。相比之下，在前一年同一研究科室的相应时间段内，仅登记了两份报告。在研究期间，瑞典其他50个老年医学科仅登记了15份报告。
尽管ADR报告的总数较少，但我们的数据表明报告率大幅提高。这表明经过指导且感兴趣的护士在发现和报告疑似ADR方面可以发挥重要作用。
