Dahri Karen, Shalansky Stephen J, Jang Linda, Jung Leon, Ignaszewski Andrew P, Clark Catherine
CSU Pharmaceutical Sciences, Vancouver Coastal Health, Vancouver, British Columbia, Canada.
Ann Pharmacother. 2008 Mar;42(3):361-7. doi: 10.1345/aph.1K385. Epub 2008 Feb 26.
British Columbia's central prescription database, PharmaNet, is often used for both clinical and research applications. However, PharmaNet details prescription transactions, not actual medication consumption, resulting in many potential sources of inaccuracy when the information is assumed to reflect population or individual drug utilization.
To assess the accuracy of PharmaNet for adherence assessment in patients with heart failure who are taking beta-blockers.
A 6-month prospective, longitudinal assessment of adherence to the prescribed beta-blocker regimen was carried out using both PharmaNet data and the Medication Event Monitoring System (MEMS) for each patient enrolled. The limit of agreement between the 2 adherence assessment methods was assessed using the Bland-Altman approach.
Fifteen of 58 patients initially enrolled in the study were excluded, most due to misuse of MEMS or failure to return the MEMS vial despite thorough follow-up. For the 43 patients included in the final analysis, mean +/- SD adherence was 97.8 +/- 11.8% when assessed by PharmaNet and 97.1 +/- 7.3% when MEMS was used. However, the limit of agreement, reported as the mean of the differences +/- 2SD, was 6.8 +/- 18.5%, indicating a moderate-to-high level of agreement between the 2 methods when the confidence interval is taken into consideration.
These results suggest that PharmaNet data accurately reflect medication adherence for most patients. The MEMS system proved unreliable in several cases, illustrating the difficulty of identifying a gold standard for adherence assessment.
不列颠哥伦比亚省的中央处方数据库PharmaNet常用于临床和研究应用。然而,PharmaNet记录的是处方交易情况,而非实际用药情况,因此当假定这些信息反映人群或个体药物使用情况时,会产生许多潜在的不准确来源。
评估PharmaNet在评估服用β受体阻滞剂的心力衰竭患者依从性方面的准确性。
对纳入的每位患者,使用PharmaNet数据和药物事件监测系统(MEMS)对规定的β受体阻滞剂治疗方案的依从性进行为期6个月的前瞻性纵向评估。使用Bland-Altman方法评估两种依从性评估方法之间的一致性界限。
最初纳入研究的58例患者中有15例被排除,大多数原因是MEMS使用不当或尽管进行了全面随访仍未归还MEMS药瓶。在最终分析中纳入的43例患者中,通过PharmaNet评估时,平均±标准差依从性为97.8±11.8%,使用MEMS时为97.1±7.3%。然而,一致性界限报告为差异均值±2标准差,为6.8±18.5%,这表明考虑置信区间时,两种方法之间存在中到高度的一致性。
这些结果表明,PharmaNet数据能准确反映大多数患者的药物依从性。MEMS系统在一些案例中被证明不可靠,这说明了确定依从性评估金标准的困难。