Background Spanish legislation considers it mandatory for clinical trials (CT) sponsors to supply investigational medicinal products (IMPs), and that the handling, storage and dispensing of IMPs in hospitals is the responsibility of the pharmacy services. This involves management of the expiry date by hospital pharmacists.
Purpose To analyse the expiry dates of IMPs received in our pharmacy service.
Material and methods Retrospective observational study in a tertiary level hospital (1,493 beds). 100% IMP deliveries between January and March 2014 were reviewed. Data collected: protocol number, reception date, IMP and number of IMP packs received, batch and expiry date. Data extraction: computer CT management application. Variables studied:%CT with deliveries with an expiry date <3 months, between 3–6 months, 9–12 months, 12–18 months, 18–24 months, 24–36 months and >36 months; number of packs with an expiry date included in the previous ranges and average days between reception until expiry.
Results 3,373 packs were received corresponding to 182 IMPs and 224 deliveries for 91 CTs. In 9.9% of CTs IMPs were received with an expiry date <3 months (112/3,373 packs), in 22% of CTs between 3–6 months (498/3, 373), 36.3% between 6–12 months (1,157/3,373), 20.9% CT between 12–18 months (920/3,373 packs), 5.5% between 18–24 months (290/3,373), 3.3% between 24–36 months (245/3,373), and in 2.2% expiry date was >36 months (169/3,373). Average days between reception until expiry, in the same ranges, were as follows: <3 months = 63 days, 3–6 months = 144 days; 6–12 months = 282 days, 12–18 months = 442 days; 18–24 months = 649 days; 24–36 months = 799 days and >36 months = 1,336 days.
Conclusion In 68.1% of CTs IMPs were received with an expiry date lower than a year, and in 46.8% of these, the expiry date was lower than 6 months. Short expiry dates involve additional workload for pharmacy services and a continuous and systematic review of expiry dates. Computer applications for CT management with configurable warning alerts assist hospital pharmacists in correct expiry date management.
References and/or acknowledgements No conflict of interest.
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