Drug Safety Center, University Hospital of Leipzig, Leipzig University, Brüderstr. 32, 04103, Leipzig, Germany.
Dept. of Clinical Pharmacy, Leipzig University, Brüderstr. 32, 04103, Leipzig, Germany.
Wien Klin Wochenschr. 2021 Aug;133(15-16):816-824. doi: 10.1007/s00508-020-01750-6. Epub 2020 Oct 22.
Potential additive effects of polypharmacy are rarely considered in adverse events of geriatric patients living in long-term care facilities. Our aim, therefore, was to identify adverse events in this setting and to assess plausible concomitant drug causes.
A cross-sectional observational study was performed in three facilities as follows: (i) adverse event identification: we structurally identified adverse events using nurses' interviews and chart review. (ii) Analysis of the concomitantly administered drugs per patient was performed in two ways: (ii.a) a review of summary of product characteristics for listed adverse drug reactions to identify possible causing drugs and (ii.b) a causality assessment according to Naranjo algorithm.
(i) We found 424 adverse events with a median of 4 per patient (range 1-14) in 103 of the 104 enrolled patients (99%). (ii.a) We identified a median of 3 drugs (range 0-11) with actually occurring adverse events listed as an adverse drug reaction in the summary of product characteristics. (ii.b) Causality was classified in 198 (46.9%) of adverse events as "doubtful," in 218 (51.2%) as "possible," in 7 (1.7%) as "probable," and in 1 (0.2%) adverse event as a "definitive" cause of the administered drugs. In 340 (80.2%) of all identified adverse events several drugs simultaneously reached the highest respective Naranjo score.
Patients in long-term facilities frequently suffer from many adverse events. Concomitantly administered drugs have to be frequently considered as plausible causes for adverse events. These additive effects of drugs should be more focused in patient care and research.
在长期护理机构居住的老年患者的不良事件中，很少考虑药物的多重用药的潜在附加作用。因此，我们的目的是确定这种情况下的不良事件，并评估可能同时存在的药物原因。
我们在三个机构中进行了一项横断面观察性研究，具体如下：（i）不良事件的识别：我们通过护士访谈和病历回顾来系统地识别不良事件。（ii）对每位患者同时使用的药物进行了两种分析：（ii.a）通过查看产品特性摘要中列出的药物不良反应来识别可能导致药物，并（ii.b）根据 Naranjo 算法进行因果关系评估。
（i）我们在 103 名纳入患者中的 104 名患者（99%）中发现了 424 起不良事件，中位数为每例 4 例（范围 1-14）。（ii.a）我们发现，中位数为 3 种药物（范围 0-11）与产品特性摘要中列为药物不良反应的实际发生的不良事件有关。（ii.b）根据因果关系评估，将 198 例（46.9%）不良事件归类为“可疑”，218 例（51.2%）为“可能”，7 例（1.7%）为“很可能”，1 例（0.2%）为“确定”药物为不良事件的原因。在所有确定的 340 例（80.2%）不良事件中，几种药物同时达到了各自最高的 Naranjo 评分。
长期护理机构的患者经常遭受许多不良事件。同时使用的药物必须经常被视为不良事件的合理原因。这些药物的附加作用应该在患者护理和研究中得到更多的关注。
