长期护理机构中固体口服剂型操作的流行率及适当性

文献信息

中文摘要

目的： 长期护理机构（LTCFs）中的药物管理因多病共存、衰弱、认知障碍、多重用药和吞咽困难而变得复杂。固体口服剂型（SODF）操作很常见，但可能损害用药安全。我们旨在确定意大利LTCFs中SODF操作的流行率并评估其适当性。
方法： 我们在82家意大利LTCFs中开展了一项全国性多中心点流行率研究（Prescription-Day LTCFs 2024）。在3400名入组居民中，排除患有急性疾病的居民以及入组少于五名居民的机构后，共纳入3174名。研究人群平均年龄为84.8岁，其中74.1%为女性，具有高多病共存、痴呆（47.9%）、多重用药（平均7.3种药物）和吞咽困难（14.7%）。SODF操作包括压碎或分割片剂、打开胶囊以及将药物与食物或液体混合。适当性采用分层框架进行评估，该框架整合了SIFO手册、Friuli Venezia Giulia“Do Not Crush”清单、TRC 2025更新、产品特性摘要和专家审查。
结果： 在20290份口服处方（15214片片剂和802粒胶囊）中，4655份SODFs（23.0%）被修改。其中，27.9%不适当，10.8%可能不适当。总体而言，1006名居民（31.7%）接受了至少一次不适当或可能不适当的修改，11.9%接受了三次或更多。胶囊的不适当操作比片剂更频繁（68.8% vs 37.7%）。经常涉及的药物包括泮托拉唑、曲唑酮和氨氯地平。暴露于不适当操作的居民更可能衰弱，并患有痴呆或吞咽困难。
结论： SODF操作在意大利LTCFs中非常普遍，超过三分之一的修改可能不适当。操作频率超过了吞咽困难的患病率，提示存在组织性和行为性驱动因素。需要标准化指导以及处方者和药师更多参与，以提高用药安全。

英文摘要

PURPOSE: Medication administration in long-term care facilities (LTCFs) is complicated by multimorbidity, frailty, cognitive impairment, polypharmacy, and dysphagia. Solid oral dosage form (SODF) manipulation is common but may compromise medication safety. We aimed to determine the prevalence of SODF manipulation and evaluate its appropriateness in Italian LTCFs.
METHODS: We conducted a national multicenter point-prevalence study (Prescription-Day LTCFs 2024) in 82 Italian LTCFs. Of the 3400 enrolled residents, 3174 were included after excluding residents with acute conditions and facilities enrolling fewer than five residents. The study population had a mean age of 84.8 years, of which 74.1% were women, with high multimorbidity, dementia (47.9%), polypharmacy (mean 7.3 medications), and dysphagia (14.7%). SODF manipulation included tablet crushing or splitting, capsule opening, and mixing medications with food or liquids. Appropriateness was evaluated using a hierarchical framework integrating the SIFO Handbook, the Friuli Venezia Giulia "Do Not Crush" list, the TRC 2025 update, the Summary of Product Characteristics, and expert review.
RESULTS: Among 20,290 oral prescriptions (15,214 tablets and 802 capsules), 4655 SODFs (23.0%) were modified. Of these, 27.9% were inappropriate and 10.8% likely inappropriate. Overall, 1006 residents (31.7%) received at least one inappropriate or likely inappropriate modification, and 11.9% received three or more. Inappropriate manipulation was more frequent for capsules than tablets (68.8% vs 37.7%). Frequently involved medications included pantoprazole, trazodone, and amlodipine. Residents exposed to inappropriate manipulation were more likely to be frail and to have dementia or dysphagia.
CONCLUSIONS: SODF manipulation is highly prevalent in Italian LTCFs, with more than one-third of modifications being potentially inappropriate. The frequency of manipulation exceeded the prevalence of dysphagia, suggesting organizational and behavioral drivers. Standardized guidance and greater prescriber and pharmacist involvement are needed to improve medication safety.