Creation of a Temperature Stability Database for Refrigerated Medications.

Aim: To create a database of refrigerated medications along with comprehensive data on their stability when stored outside the recommended conditions; and to develop an educational tool for managing cold chain emergencies at the hospital. Method: Phase 1: a searchable database was created with fields on product stability, stored temperatures and storage conditions. Phase 2: the database was populated with the products' stability data from various sources, such as literature searches, approved product information and pharmaceutical companies. Phase 3: focus groups were held with the hospital's stakeholders (nurses, pharmacists, pharmacy technicians) to develop an educational tool for managing cold chain emergencies. Results: Of the 36 pharmaceutical companies contacted, 29 responded (response rate 81%) and provided 'extra' stability data for 28 products (n = 150; 19%). Pursuant to issues raised by the pharmaceutical companies about concerns of breaching the registration conditions of their products and misinterpretation of the provided in-house stability data, a stakeholder meeting was held with the Therapeutic Goods Administration. At the meeting, the need for short-term 'end of shelf life' real-time stability studies for refrigerated products was discussed. An educational tool was designed based on a survey of local practices at the hospital pertaining to monitoring refrigerators used to store medications. Conclusion: Creation of the database has resulted in a critical analysis of the existing stability data on refrigerated medications. Hospital staff lack guidance on the selection, monitoring and maintenance of refrigerators used to store medications, and to manage cold chain emergencies. There is an opportunity for professional pharmacy organisations to provide this guidance. [ABSTRACT FROM AUTHOR]