Gandhi Tejal K, Weingart Saul N, Borus Joshua, Seger Andrew C, Peterson Josh, Burdick Elisabeth, Seger Diane L, Shu Kirstin, Federico Frank, Leape Lucian L, Bates David W
Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA 02115, USA.
N Engl J Med. 2003 Apr 17;348(16):1556-64. doi: 10.1056/NEJMsa020703.
Adverse events related to drugs occur frequently among inpatients, and many of these events are preventable. However, few data are available on adverse drug events among outpatients. We conducted a study to determine the rates, types, severity, and preventability of such events among outpatients and to identify preventive strategies.
We performed a prospective cohort study, including a survey of patients and a chart review, at four adult primary care practices in Boston (two hospital-based and two community-based), involving a total of 1202 outpatients who received at least one prescription during a four-week period. Prescriptions were computerized at two of the practices and handwritten at the other two.
Of the 661 patients who responded to the survey (response rate, 55 percent), 162 had adverse drug events (25 percent; 95 percent confidence interval, 20 to 29 percent), with a total of 181 events (27 per 100 patients). Twenty-four of the events (13 percent) were serious, 51 (28 percent) were ameliorable, and 20 (11 percent) were preventable. Of the 51 ameliorable events, 32 (63 percent) were attributed to the physician's failure to respond to medication-related symptoms and 19 (37 percent) to the patient's failure to inform the physician of the symptoms. The medication classes most frequently involved in adverse drug events were selective serotonin-reuptake inhibitors (10 percent), beta-blockers (9 percent), angiotensin-converting-enzyme inhibitors (8 percent), and nonsteroidal antiinflammatory agents (8 percent). On multivariate analysis, only the number of medications taken was significantly associated with adverse events.
Adverse events related to drugs are common in primary care, and many are preventable or ameliorable. Monitoring for and acting on symptoms are important. Improving communication between outpatients and providers may help prevent adverse events related to drugs.
与药物相关的不良事件在住院患者中频繁发生,其中许多事件是可预防的。然而,关于门诊患者药物不良事件的数据却很少。我们开展了一项研究,以确定门诊患者中此类事件的发生率、类型、严重程度和可预防性,并确定预防策略。
我们在波士顿的四家成人初级保健机构(两家基于医院,两家基于社区)进行了一项前瞻性队列研究,包括对患者的调查和病历审查,共涉及1202名在四周内至少接受过一次处方的门诊患者。其中两家机构的处方采用计算机化,另外两家则为手写。
在661名回复调查的患者中(回复率为55%),有162名发生了药物不良事件(25%;95%置信区间为20%至29%),共发生181起事件(每100名患者27起)。其中24起事件(13%)为严重事件,51起(28%)为可改善事件,20起(11%)为可预防事件。在51起可改善事件中,32起(63%)归因于医生未对药物相关症状做出反应,19起(37%)归因于患者未告知医生症状。药物不良事件中最常涉及的药物类别为选择性5-羟色胺再摄取抑制剂(10%)、β受体阻滞剂(9%)、血管紧张素转换酶抑制剂(8%)和非甾体抗炎药(8%)。多因素分析显示,只有用药数量与不良事件显著相关。
在初级保健中,与药物相关的不良事件很常见,许多是可预防或可改善的。对症状进行监测并采取相应措施很重要。改善门诊患者与医疗服务提供者之间的沟通可能有助于预防与药物相关的不良事件。