Jarernsiripornkul N, Krska J, Capps P A G, Richards R M E, Lee A
School of Pharmacy, The Robert Gordon University, Schoolhill, Aberdeen, UK.
Br J Clin Pharmacol. 2002 Mar;53(3):318-25. doi: 10.1046/j.0306-5251.2001.01547.x.
To develop a systematic generic method of enabling patients to report symptoms which they believe to be due to a particular prescribed drug.
A piloted body system-based questionnaire was distributed to patients registered with 79 medical practices in Grampian prescribed one of nine recently marketed 'black triangle' drugs. These comprised four antidepressants, three antiepileptics and two analgesics. This requested respondents to identify any symptoms experienced over the previous year which they thought could be due to the 'black triangle' drug they had used. A sample of medical records was examined to compare symptoms recorded with those reported by patients. A classification system was developed for the study to enable the assessment of symptoms reported for their potential relationship to patients' drug therapy. All symptoms reported were classified, taking into account information provided by patients on their concomitant drugs and diseases. A specialist pharmacist independently re-classified a sample of the symptoms to validate the process.
A 36.3% response rate was obtained (837/2307) with 742 respondents (88.6%) reporting at least one symptom. The median per patient was 6.0 (range 0--71), with almost half (406, 48.5%) reporting fewer than five symptoms. Most symptoms (71.0%) were classified as being probably or possibly related to the drugs studied. Agreement between researcher and specialist on the classification of 75.3% of 716 symptoms was obtained (Kappa=0.563). Responses from patients prescribed antidepressant drugs were more likely to include symptoms potentially caused by these drugs (74.5% of all symptoms reported) than those from patients prescribed analgesics (67.4%) or antiepileptics (65.1%, chi2 = 23.858, d.f. = 2, P < 0.001). Patients reporting large numbers of symptoms were more likely to report some which were classed as unlikely to be an ADR or unattributable (chi2 = 80.587, d.f. = 3, P < 0.001). Of the 742 reporting symptoms in questionnaires, 402 (54.2%) claimed to have reported some or all of these to their doctor. Only 162 (22.6%) of 716 patient-reported symptoms were documented in the primary care medical records of 103 patients prescribed tramadol or venlafaxine.
Respondents were clearly willing to report symptoms, the majority of which were classed as possibly/probably related to the drugs studied. The results suggest that patients do not report all symptoms they suspect to be ADRs to their GP and that GPs do not record all symptoms which may be reported to them. The method could help to identify problems which patients perceive as being related to their drug therapy and contribute to increased ADR reporting.
开发一种系统通用的方法，使患者能够报告他们认为由特定处方药引起的症状。
向在格兰扁地区79家医疗机构注册并正在服用九种近期上市的“黑三角”药物之一的患者发放一份经过试点的基于身体系统的问卷。这些药物包括四种抗抑郁药、三种抗癫痫药和两种镇痛药。问卷要求受访者识别他们在过去一年中经历的任何他们认为可能由所服用的“黑三角”药物引起的症状。检查了一份病历样本，以比较记录的症状与患者报告的症状。为该研究开发了一种分类系统，以便能够评估所报告症状与患者药物治疗的潜在关系。考虑到患者提供的关于其合并用药和疾病的信息，对所有报告的症状进行分类。一名专科药剂师独立地对一部分症状进行重新分类，以验证该过程。
获得了36.3%的回复率（837/2307），742名受访者（88.6%）报告了至少一种症状。每位患者报告症状的中位数为6.0（范围0 - 71），几乎一半（406，48.5%）报告的症状少于五种。大多数症状（71.0%）被分类为可能或可能与所研究的药物有关。研究人员与专科医生对716种症状中的75.3%的分类达成了一致（卡帕值 = 0.563）。服用抗抑郁药的患者报告的症状中，更有可能包括这些药物可能引起的症状（所报告的所有症状的74.5%），而服用镇痛药的患者（67.4%）或抗癫痫药的患者（65.1%）则不然（卡方 = 23.858，自由度 = 2，P < 0.001）。报告大量症状的患者更有可能报告一些被归类为不太可能是药物不良反应或无法归因的症状（卡方 = 80.587，自由度 = 3，P < 0.001）。在问卷中报告症状的742名患者中，402名（54.2%）声称已向医生报告了其中一些或全部症状。在103名服用曲马多或文拉法辛的患者的初级保健病历中，仅记录了716名患者报告症状中的162名（22.6%）。
受访者显然愿意报告症状，其中大多数被分类为可能/可能与所研究的药物有关。结果表明，患者不会向他们的全科医生报告所有他们怀疑是药物不良反应的症状，并且全科医生也不会记录所有可能向他们报告的症状。该方法有助于识别患者认为与他们的药物治疗有关的问题，并有助于增加药物不良反应报告。
