Martin R M, Shakir S
Department of Social Medicine, University of Bristol, England.
Drug Saf. 2001;24(6):475-81. doi: 10.2165/00002018-200124060-00005.
Prescription event monitoring is a national drug safety surveillance scheme in which prescribers are prompted to report events and deaths following prescription of newly marketed drugs. This paper presents age- and gender-specific asthma death rates in patients prescribed the long-acting beta2-agonists salmeterol and bambuterol.
Pharmacosurveillance cohort study of general practice patients in England.
15 406 patients prescribed salmeterol between December 1990 and May 1991, and 8098 patients prescribed bambuterol between February 1993 and December 1995.
Patients prescribed these drugs by general practitioners in England were identified using the national pharmacovigilance system of prescription event monitoring, in which details of all dispensed prescriptions were provided in confidence by the Prescription Pricing Authority. Questionnaires were sent to the prescriber asking for details of events occurring after the first prescription. In each study an attempt was made to establish the cause of all deaths reported on the questionnaires, via retrieval of the patients' medical notes or examination of death certificates.
There was little evidence of heterogeneity in the drug-specific death rates and we therefore present the combined age- and gender-specific death rates for the 2 cohorts. Overall, there were 85 asthma deaths among people taking the long-acting beta2-agonists studied (bambuterol and salmeterol cohorts combined). The overall death rate was 2.33 [95% confidence interval (CI) 1.84 to 2.84] per 10000 months of observation. There were 37 asthma deaths among male patients (rate 2.40 per 10000 months of observation; 95% CI 1.74 to 3.40) and 48 asthma deaths among female patients (rate 3.08 per 10000 months of observation; 95% CI 2.21 to 3.98). There was no difference in death rates when male and female patients were compared (rate ratio 0.78; 95% CI 0.49 to 1.22; p = 0.26).
Prescription event monitoring is a form of prompted surveillance allowing rapid, uniform, national and practical assessment of newly marketed drugs on large cohorts of patients in England. These data provide benchmark rates from which to assess the performance of newly prescribed anti-asthma drugs and generate hypotheses for later analytical investigation in which confounding by indication and asthma severity can be controlled for. Any differences in these rates should be considered as a source of signal generation within the context of a surveillance programme, rather than as robust evidence of any mortality differential between drugs.
处方事件监测是一项全国性药品安全监测计划，促使开处方者报告新上市药品处方后的事件和死亡情况。本文介绍了使用长效β2受体激动剂沙美特罗和班布特罗的患者中按年龄和性别划分的哮喘死亡率。
对英格兰全科医疗患者进行的药物监测队列研究。
1990年12月至1991年5月期间，15406例患者使用了沙美特罗；1993年2月至1995年12月期间，8098例患者使用了班布特罗。
利用全国性的处方事件监测药物警戒系统识别英格兰全科医生开具这些药物的患者，处方定价机构会保密提供所有配药处方的详细信息。向开处方者发送问卷，询问首张处方后发生的事件详情。在每项研究中，都试图通过查阅患者病历或检查死亡证明来确定问卷中报告的所有死亡原因。
特定药物死亡率几乎没有异质性证据，因此我们列出了这两个队列合并后的按年龄和性别划分的死亡率。总体而言，在使用所研究的长效β2受体激动剂（班布特罗和沙美特罗队列合并）的人群中，有85例哮喘死亡。总体死亡率为每10000观察月2.33[95%置信区间（CI）1.84至2.84]。男性患者中有37例哮喘死亡（每10000观察月死亡率为2.40；95%CI 1.74至3.40），女性患者中有48例哮喘死亡（每10000观察月死亡率为3.08；95%CI 2.21至3.98）。比较男性和女性患者的死亡率时没有差异（率比0.78；95%CI 0.49至1.22；p = 0.26）。
处方事件监测是一种主动监测形式，能对英格兰大量患者群体中的新上市药品进行快速、统一、全国性且实用的评估。这些数据提供了基准率，可据此评估新开具的抗哮喘药物的性能，并为后续分析研究生成假设，在后续研究中可以控制适应症和哮喘严重程度的混杂因素。在监测计划的背景下，这些率的任何差异都应被视为信号产生的来源，而不是作为药物之间任何死亡率差异的有力证据。
