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Introduction: IDF Medical Supply Service provides medications and medical supplies in emergency scenarios, through medical supply kits stored in IDF stockpiles, and are refreshed once every 18 months. Medical supplies are authorized for use according to strict regulations, however, due to the exposure to uncontrollable storage conditions, examination and quality assessment based on pharmaceutical and analytical research are regularly conducted by the IDF Pharmacy Branch's analytical lab. Objective: This study examined the efficacy and stability of Morphine Amp. and Ketamine Vials stored in uncontrolled (field) conditions, compared to manufacturer recommended conditions.
Methods: Tests performed included active entity analysis (assay), presence of degradation products, particulate matter quantification, pH, elemental impurities and pharmacological efficacy in rats. Studied drugs were stored at controlled: (A) Room Temperature (250C); (B) Accelerated Conditions (400C); and uncontrolled (C) Field conditions, and sampled at 3-time intervals: 0, 6 months and 12 months. Samples stored at 00C throughout the year were used as a reference.
Results: Morphine Amp: There was no change or deviation from normal range in assay results, degradation products, particulate matter, pH and pharmacological efficacy in rats. Moderate increases in Al and Si concentrations were measured in correlation with storage period. Ketamine Vial: There was no significant change in particle concentration, pH or pharmacological efficacy in rats. Slight increases in Ketamine Zn, Cr, Al and Si concentrations after 400C storage was found.
Discussion & Conclusions: Studied medications were found relatively stable in all groups and results were within defined IDF and manufacturer specifications. However, signs of accelerated glass and rubber (packing components) degradation in medications stored at high temperature were evident, a finding that emphasizes the importance of demand for high quality package components and necessity of continuous evaluation of these parameters in additional batches of medications stored at different storage conditions and for longer time periods.
Keywords: Morphine stability; Ketamine stability; Morphine degradation; Ketamine degradation; Storage conditions of medicines; Uncontrolled storage conditions.