Beyond use date of drugs

Context: There are standards that allow establishing the microbiological and physicochemical stability of a medicine; however, beyond use date of drugs depends not only on these criteria, but also on individual institutional characteristics. The multiple factors that involve the allocation of the st...

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Main Authors: Laura M. Rendón, Sara Lopera, Naira Y. Valencia
Format: Article
Language:English
Published: GarVal Editorial Ltda. 2018-09-01
Series:Journal of Pharmacy & Pharmacognosy Research
Subjects:
Online Access:http://jppres.com/jppres/pdf/vol6/jppres18.406_6.5.412.pdf
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author Laura M. Rendón
Sara Lopera
Naira Y. Valencia
author_facet Laura M. Rendón
Sara Lopera
Naira Y. Valencia
author_sort Laura M. Rendón
collection DOAJ
description Context: There are standards that allow establishing the microbiological and physicochemical stability of a medicine; however, beyond use date of drugs depends not only on these criteria, but also on individual institutional characteristics. The multiple factors that involve the allocation of the stability of a medication, if not properly articulated, can lead to therapeutic failures and adverse events in patients. Aims: To design an algorithm to determine the stability beyond use date of a drug in a high complexity healthcare institution. Methods: Pharmaceutical form, packaging, and administration route were defined for each drug. Physicochemical and microbiological stability were assigned to each product. An algorithm was built with the collected information. The stability beyond use date was the shortest time registered between microbiological and physicochemical stability, however, the information of the manufacturer was respected. Results: A total of 938 drugs were analyzed, which 606 (64.6%) were considered as single-dose and 332 (35.4%) as multiple-dose. The mean reason to assign a drug as a single-dose with 90.9% was pharmaceutical form unable to storage, tablet, capsule, and ampoule the most frequent. The main cause with 54.4% to assign a drug as multiple-dose was synthetic products with liquid and semisolid pharmaceutical forms whose packaging materials were allowed to storage after its first use. Conclusions: An algorithm was designed, which can assign the stability beyond use date of drugs using an easy and reliable, generating a more safety use inside the institution.
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spelling doaj.art-765fd64d023346f1921ebc31c50308e12022-12-21T19:05:29ZengGarVal Editorial Ltda.Journal of Pharmacy & Pharmacognosy Research0719-42502018-09-0165412423Beyond use date of drugsLaura M. Rendón0Sara Lopera1Naira Y. Valencia2Servicio de Vigilancia Farmacológica, Hospital Universitario de San Vicente Fundación, calle 64 No 51d – 154, Código Postal 050010, Medellín, Colombia. Centro de Información y Estudio de Medicamentos y Tóxicos (CIEMTO), Facultad de Medicina, Universidad de Antioquia, carrera 51d No 62 – 42, Código Postal 050010, Medellín, Colombia.Servicio de Vigilancia Farmacológica, Hospital Universitario de San Vicente Fundación, calle 64 No 51d – 154, Código Postal 050010, Medellín, Colombia.Servicio de Vigilancia Farmacológica, Hospital Universitario de San Vicente Fundación, calle 64 No 51d – 154, Código Postal 050010, Medellín, Colombia. Facultad de Ciencias Farmacéuticas y Alimentarias, Universidad de Antioquia, calle 67 No. 53 – 108, Código Postal 050010, Medellín, Colombia.Context: There are standards that allow establishing the microbiological and physicochemical stability of a medicine; however, beyond use date of drugs depends not only on these criteria, but also on individual institutional characteristics. The multiple factors that involve the allocation of the stability of a medication, if not properly articulated, can lead to therapeutic failures and adverse events in patients. Aims: To design an algorithm to determine the stability beyond use date of a drug in a high complexity healthcare institution. Methods: Pharmaceutical form, packaging, and administration route were defined for each drug. Physicochemical and microbiological stability were assigned to each product. An algorithm was built with the collected information. The stability beyond use date was the shortest time registered between microbiological and physicochemical stability, however, the information of the manufacturer was respected. Results: A total of 938 drugs were analyzed, which 606 (64.6%) were considered as single-dose and 332 (35.4%) as multiple-dose. The mean reason to assign a drug as a single-dose with 90.9% was pharmaceutical form unable to storage, tablet, capsule, and ampoule the most frequent. The main cause with 54.4% to assign a drug as multiple-dose was synthetic products with liquid and semisolid pharmaceutical forms whose packaging materials were allowed to storage after its first use. Conclusions: An algorithm was designed, which can assign the stability beyond use date of drugs using an easy and reliable, generating a more safety use inside the institution.http://jppres.com/jppres/pdf/vol6/jppres18.406_6.5.412.pdfdosage formsdrug packagingdrug stabilitydrug storagepharmaceutical preparationspharmaceutical technology
spellingShingle Laura M. Rendón
Sara Lopera
Naira Y. Valencia
Beyond use date of drugs
Journal of Pharmacy & Pharmacognosy Research
dosage forms
drug packaging
drug stability
drug storage
pharmaceutical preparations
pharmaceutical technology
title Beyond use date of drugs
title_full Beyond use date of drugs
title_fullStr Beyond use date of drugs
title_full_unstemmed Beyond use date of drugs
title_short Beyond use date of drugs
title_sort beyond use date of drugs
topic dosage forms
drug packaging
drug stability
drug storage
pharmaceutical preparations
pharmaceutical technology
url http://jppres.com/jppres/pdf/vol6/jppres18.406_6.5.412.pdf
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