Tjia Jennifer, Field Terry S, Mazor Kathleen M, Donovan Jennifer L, Kanaan Abir O, Reed George, Doherty Peter, Harrold Leslie R, Gurwitz Jerry H
University of Massachusetts Medical School, Worcester, MA 01605, USA.
Am J Geriatr Pharmacother. 2012 Oct;10(5):323-30. doi: 10.1016/j.amjopharm.2012.09.003.
Little attention has been focused on the safety of medications administered to treat non illnesses in nursing home residents with dementia. It is unclear whether this population is at increased risk of adverse drug events.
To test the hypotheses that in nursing home residents with dementia prescribed warfarin have less time in therapeutic range and a higher incidence of nonpreventable and preventable adverse warfarin events compared to nursing home residents without dementia after controlling for facility and patient characteristics.
A prospective cohort embedded in a clinical trial of nursing home residents prescribed warfarin in 26 nursing homes in Connecticut was observed for up to 12 months. The primary outcome measures included adverse warfarin events (AWEs) (injuries resulting from warfarin use), potential AWEs (INR [international normalized ratio] >4.5 and management error), and AWE preventability based on physician reviews of medical record abstractions. Potential confounders included nursing home structural characteristics (eg, number of beds and for-profit status), nursing staff time, and nursing home regulatory deficiencies (pharmacy, administrative, quality of care, and all other deficiencies). Multivariable Poisson regression analysis was used to determine the independent association of dementia with potential and preventable AWEs using generalized estimating equations to account for clustering within nursing homes.
Residents with dementia had no difference in the number of INR monitoring tests or percentage of days in the therapeutic range, but did have an increased risk of AWEs (adjusted incidence rate ratio [IRR], 1.47; 95% confidence interval [CI], 1.20-1.82), and preventable or potential AWEs (adjusted IRR, 1.36; 95% CI, 1.06-1.76) after adjustment for patient characteristics, nursing home quality, and case mix. Greater nursing staff time was protective for preventable and potential AWEs (adjusted IRR, 0.66; 95% CI, 0.48-0.90) but not for nonpreventable AWEs.
A diagnosis of dementia was associated with increased risk of nonpreventable and preventable or potential AWEs. Greater nursing staff time was associated with lower risk of preventable AWEs. These findings have implications for quality-of-care reporting and patient safety.
对于养老院中患有痴呆症的居民使用药物治疗非疾病情况时的安全性，关注较少。尚不清楚该人群发生药物不良事件的风险是否增加。
检验以下假设：在控制了机构和患者特征后，与无痴呆症的养老院居民相比，使用华法林的痴呆症养老院居民处于治疗范围内的时间更短，且非可预防性和可预防性华法林不良事件的发生率更高。
对康涅狄格州26家养老院中正在使用华法林的养老院居民进行的一项临床试验中的前瞻性队列进行了长达12个月的观察。主要结局指标包括华法林不良事件（AWEs）（因使用华法林导致的伤害）、潜在AWEs（国际标准化比值[INR]>4.5以及管理失误），以及基于医生对病历摘要审查的AWE可预防性。潜在混杂因素包括养老院结构特征（如床位数量和营利状态）、护理人员时间，以及养老院监管缺陷（药房、行政、护理质量及所有其他缺陷）。使用多变量泊松回归分析，通过广义估计方程来确定痴呆症与潜在及可预防性AWEs之间的独立关联，以考虑养老院内部的聚类情况。
患有痴呆症的居民在INR监测测试次数或处于治疗范围内的天数百分比方面没有差异，但在调整患者特征、养老院质量和病例组合后，发生AWEs的风险增加（调整后的发病率比值[IRR]，1.47；95%置信区间[CI]，1.20 - 1.82），以及发生可预防性或潜在AWEs的风险增加（调整后的IRR，1.36；95%CI，1.06 - 1.76）。更多的护理人员时间对可预防性和潜在AWEs具有保护作用（调整后的IRR，0.66；95%CI，0.48 - 0.90），但对非可预防性AWEs没有保护作用。
痴呆症诊断与非可预防性以及可预防性或潜在AWEs的风险增加相关。更多的护理人员时间与可预防性AWEs的较低风险相关。这些发现对护理质量报告和患者安全具有启示意义。
