Herdeiro Maria T, Figueiras Adolfo, Polónia Jorge, Gestal-Otero J J
Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Santiago de Compostela, SpainNorthern Polytechnic Health Institute (Cooperativa de Ensino Superior Politécnico e Universitário [CESPU]), Gandra, Porto, Portugal.
Drug Saf. 2006;29(4):331-40. doi: 10.2165/00002018-200629040-00004.
Pharmacists can play a fundamental role in adverse drug reaction (ADR) reporting, although the factors that affect underreporting among these professionals are unknown. The objectives of this study were to identify (i) professional or demographic characteristics; and (ii) attitudes associated with pharmacists' ADR reporting in northern Portugal.
We conducted a case-control study on a population of pharmacists employed in hospital and community pharmacies across Portugal's Northern Regional Health Authority catchment area in 2003. Cases (n=34) comprised pharmacists who had reported at least one ADR to the northern region's drug surveillance unit, and controls (n=280) were randomly sampled from pharmacists who had never reported an ADR. All were interviewed using a mail questionnaire. Most attitudes were based on Inman's 'seven deadly sins' and were measured using a continuous visual analogue scale. Answers were recorded in a range from 0 (total disagreement) to 10 (total agreement). Logistic regression was used to determine the ADR reporting adjusted odds ratio (OR) for a change in exposure corresponding to the interquartile range for each attitude.
The response rate was 86.8%. Reporting probability proved higher among hospital versus community pharmacists (adjusted OR 20.0; 95 CI 3.3, 125.0; p<0.001). Attitudes to ADRs were strongly associated with reporting probability. Hence, an interquartile decrease in any of the following attitudes increased the probability of reporting by (i) 223% (95% CI 51, 595; p < 0.05) for "Really serious ADRs are well documented by the time a drug is marketed"; (ii) 240% (95% CI 89, 508; p=0.002) for "I would only report an ADR if I were sure that it was related to the use of a particular drug"; (iii) 316% (95% CI 44, 1104; p=0.010) for "It is only necessary to report serious or unexpected ADRs"; and (iv) 171% (95% CI 13, 549; p=0.020) for "I do not have time to think about the involvement of the drug or other causes in ADRs".
ADR under-reporting is strongly associated with certain attitudes, possibly indicating that under-reporting could be minimised through educational interventions targeted at changing such attitudes. Pharmacists' ADR education must be improved and educational programmes should be focused on altering attitudes identified by the study as being associated with under-reporting. Our data also indicate that community pharmacists must be a priority target for this intervention.
药剂师在药物不良反应（ADR）报告中可发挥重要作用，尽管影响这些专业人员报告不足的因素尚不清楚。本研究的目的是确定：（i）专业或人口统计学特征；（ii）与葡萄牙北部药剂师ADR报告相关的态度。
2003年，我们对葡萄牙北部地区卫生局辖区内医院和社区药房的药剂师群体进行了一项病例对照研究。病例组（n = 34）包括至少向北部地区药物监测部门报告过一例ADR的药剂师，对照组（n = 280）是从未报告过ADR的药剂师中随机抽取的。所有人员均通过邮寄问卷进行访谈。大多数态度基于英曼的“七宗罪”，并使用连续视觉模拟量表进行测量。答案记录范围为0（完全不同意）至10（完全同意）。采用逻辑回归确定每种态度对应四分位间距暴露变化时的ADR报告调整比值比（OR）。
回复率为86.8%。结果表明，医院药剂师的报告概率高于社区药剂师（调整后的OR为20.0；95%置信区间为3.3, 125.0；p < 0.001）。对ADR的态度与报告概率密切相关。因此，以下任何一种态度的四分位间距减小会使报告概率增加：（i）“在药物上市时，真正严重的ADR已有充分记录”，增加223%（95%置信区间为51, 595；p < 0.05）；（ii）“只有当我确定ADR与特定药物的使用有关时才会报告”，增加240%（95%置信区间为89, 508；p = 0.002）；（iii）“只需要报告严重或意外的ADR”，增加316%（95%置信区间为44, 1104；p = 0.010）；（iv）“我没有时间思考药物或其他原因在ADR中的作用”，增加171%（95%置信区间为13, 549；p = 0.020）。
ADR报告不足与某些态度密切相关，这可能表明通过针对改变此类态度的教育干预可将报告不足降至最低。必须改进药剂师ADR教育，教育计划应侧重于改变本研究中确定的与报告不足相关的态度。我们的数据还表明，社区药剂师必须是该干预措施的优先目标。
