Privatsphäre-Einstellungen

Sicherung der Qualität von kühlpflichtigen Arzneimitteln

Elisabeth Adams¹, Herbert Plagge¹, Christian Surber², Stefanie Deuster¹

¹ Universitätsspital Basel, Spital-Pharmazie, Basel (Schweiz)
² Spirig Pharma AG, Egerkingen (Schweiz)

Correspondence: Dr. rer. nat. Herbert Plagge, Universitätsspital Basel, Spital-Pharmazie, Spitalstr. 26, 4031 Basel (Schweiz); e-mail: hplagge@uhbs.ch

There are lots of processes in the distribution of refrigerated drugs prior to administration to the patient. They have an influence on the quality, efficacy and safety. Therefore, in the distribution chain the steps shipping and storage were verified and optimised. The shipment from the hospital pharmacy to its customers has been analysed, optimised and subsequently validated. The validated transport boxes keep the temperature conditions 2–8 °C over a period of at least one hour. The procedure of distribution from the hospital pharmacy to the customers agrees with the internal criteria of the hospital pharmacy and ensures continuous drug quality.
Furthermore various types of refrigerators on the wards were reviewed and compared with regard to their suitability for the storage of medicinal products. The investigation showed that in the food refrigerators the temperature is not in the range of 2–8 ° C over long periods. Especially in the compartments of the door higher temperatures than 8 °C were measured. In the investigated medicinal refrigerators the temperatures are predominantly in the range of 2–8 °C. The outcome of this investigation is that food refrigerators are not suitable for proper storage of pharmaceutical products. Medicinal refrigerators should be used. The review, analysis and validation could detect and eliminate problems during the process steps. Accordingly this project contributes to assure the quality of refrigerated medicines.

Key words Arzneimittel • Kühlschrank • Kühltransport • Lagerungsbedingung • Qualitätssicherung