A model for the clinical management of the introduction of new medicines in a large University Hospital in Spain.

IF 2.6 Q1 HEALTH POLICY & SERVICES
Journal of Pharmaceutical Policy and Practice Pub Date : 2026-09-18 eCollection Date: 2026-01-01 DOI:10.1080/20523211.2026.2730801
Immaculada Danés, Antònia Agustí, Elena Ballarín, Patricia Marrero, Guillem Vancells, Salvador Clemente, Mar Vila, Sonia Cortés, María José Abadías, Maria Queralt Gorgas, Eduard Diogène
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Abstract

Background: New medicines offer therapeutic opportunities but also challenge healthcare system organisation and sustainability. This study aims to describe a model based on regular multidisciplinary meetings to manage and monitor the introduction of new medicines for Hospital Outpatient Treatments (HOT) in a Spanish tertiary hospital, and the observed results after its implementation.

Methods: Meetings held during 2016-2023 and related documents were retrospectively reviewed. The meeting agenda and minutes included information on new drugs, follow-up of compliance with data collection in the Register of Patients and Treatments, drug expenditure, number of treated patients, quality/efficiency indicators, and agreements. An observational, descriptive study with a mixed approach (quantitative analysis of expenditure and activity data and qualitative documentary analysis) was performed. Percentage changes are expressed as relative changes.

Results: During this period, 242 meetings with 12 selected clinical departments/units were held. A total of 284 agreements were reached, most of them related to the need to improve registry data (37.7%), and promoting the use of generic/biosimilar drugs (18.3%). A 40.2% increase in HOT expenditure, a 55.4% increase in the number of treated patients, and a 9.7% decrease in the cost per patient were documented in these departments from 2016 to 2023. The greatest HOT expenditure was observed in Haematology and Oncology (reaching around 39 and 28 million euros annually in 2023, respectively). The most marked increases occurred in Pneumology and Allergology. The use of generic/biosimilar drugs in Infectious diseases and Rheumatology departments had a more noticeable impact, with decreases in HOT expenditure of 15.8% and 6.6%, respectively. While caution is needed when interpreting the data, a lower increase in HOT expenditure was observed in the departments/units in which meetings were held.

Conclusion: Having a consolidated method for the introduction and monitoring of new medications helps to set up an organised and reasoned decision-making process.

西班牙某大型大学医院引进新药的临床管理模式。
背景:新药物提供治疗机会,但也挑战卫生保健系统的组织和可持续性。本研究旨在描述一个基于定期多学科会议的模式,以管理和监测医院门诊治疗新药的引进(HOT)在西班牙三级医院,并观察其实施后的结果。方法:回顾性回顾2016-2023年召开的会议及相关文件。会议议程和会议记录包括新药信息、患者和治疗登记册数据收集的依从性跟踪、药物支出、治疗患者数量、质量/效率指标和协议。进行了一项观察性描述性研究,采用混合方法(支出和活动数据的定量分析和定性文献分析)。百分比变化表示为相对变化。结果:在此期间,共与选定的12个临床科室/单位召开了242次会议。共达成284项协议,其中大多数涉及改进注册数据(37.7%)和促进仿制药/生物类似药的使用(18.3%)。从2016年到2023年,这些部门的HOT支出增加了40.2%,治疗患者数量增加了55.4%,每位患者的成本下降了9.7%。血液学和肿瘤学领域的HOT支出最大(2023年分别达到约3900万欧元和2800万欧元)。最显著的增加发生在肺炎学和过敏学。传染病科和风湿科使用仿制药/生物仿制药的影响更为明显,HOT支出分别下降15.8%和6.6%。虽然在解释数据时需要谨慎,但在举行会议的部门/单位观察到,HOT支出的增幅较低。结论:有一个统一的方法来引进和监测新药有助于建立一个有组织和合理的决策过程。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Pharmaceutical Policy and Practice
Journal of Pharmaceutical Policy and Practice Health Professions-Pharmacy
CiteScore
4.70
自引率
9.50%
发文量
81
审稿时长
14 weeks
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