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2SPD-003 Use of foreign medicines to manage drug shortages: economic, resource and safety impact in a tertiary hospital

ejhpharm · 2026-03-18 · canonical JSON source

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Background and Importance Drug shortages frequently compromise healthcare delivery and patient safety. One mitigation strategy is the importation of foreign medicines by the Spanish Medicines Agency (AEMPS) as substitutes for unavailable national products. These alternatives increase costs and resource demands, potentially generating economic, organisational, and safety impacts for hospitals.Aim and Objectives To identify medicines affected by shortages and supplied through foreign imports, and to assess their economic, resource, and safety impact.Material and Methods A retrospective observational study was conducted in the Pharmacy Service of a tertiary hospital from January 2024 to July 2025, including all medicines affected by shortages and replaced with foreign imports. Stock data, national drug prices, and consumption were obtained from the hospital logistics management software (Orion Logis), while foreign medicine prices were provided by the AEMPS. Economic impact was assessed by comparing unit sale prices of national and foreign medicines, considering monthly consumption and months of foreign supply. Resource and safety impacts were jointly evaluated through the need for relabelling foreign medicines when labelling was in a complex language, and through the drafting of informative notes for hospital units in cases of major changes in dose, concentration, or volume.Results Forty-one national medicines in shortage were replaced with foreign imports, of which 24 (58.5%) later returned to national supply. The most affected pharmacotherapeutic groups were anti-infectives (31.7%, n=13), psychotropics (17.1%, n=7), cardiovascular drugs (14.6%, n=6), and antineoplastics (9.8%, n=4). In five cases (12.2%), a second substitution with a foreign medicine was required due to recurrent shortages. Economically, the price of foreign medicines was higher in all cases, with a median of 4.3 (1.8–7.5) times higher. Considering monthly consumption and the shortage period, total expenditure increased by €209,419. Regarding safety and resource impact, four drugs (9.8%) required relabelling due to poorly understandable foreign-language labelling, and six (14.6%) required informative notes for hospital units owing to presentation differences (dose, concentration, or volume) that could pose patient risks.Conclusion and Relevance Managing drug shortages with foreign imports requires a necessary strategy but entails substantial economic and organisational impact, along with safety risks from foreign-language labelling and presentation differences. Larger studies and preventive strategies are needed to mitigate these consequences and optimise hospital pharmacy practice.Conflict of Interest No conflict of interest