Stability problems of non-essential drugs used in hospitals in Thailand.
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Date
1999-07
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Abstract
A study of stability problems of non-essential drugs purchased by 658 hospitals in Thailand has been carried out since 1993. During 1990-1997, selective sampling of 316 cases related to stability problems of non-essential drugs was undertaken through questionnaires sent to 658 government hospitals and from laboratory findings. The stability problems were identified and categorised into pharmacopoeial non-compliance (56.3 per cent) and physical appearances (43.7 per cent). Most problems (81.0 per cent) occur in locally-made drug products. In addition, 87.3 per cent of drugs were found to have no expiration dates stated on the labels and instability was found between 1-3 months and over 7 years after manufacturing, with the highest frequency of occurrence falling within 10-12 months (25.6 per cent). For products with a stated shelf-life, stability problems in 29 samples occurred in 5 to 100 per cent of shelf-life period, with 11 expired samples being reported. The problem was mainly found in drugs in tablet form (58.9 per cent), followed by injectable drugs (18.0 per cent) and oral liquid preparations (11.7 per cent). The problem was largely found in drugs which had transparent glass bottle packages (22.8 per cent) and semi-transparent plastic bottle packages (24.1 per cent). Factors affecting the stability of drug products have already been stated in many textbooks on stability; however, some drug substances have not been mentioned in any book. Therefore, to avoid stability problems, proper formulations must be developed using standard quality raw materials and packaging under Good Manufacturing Practices requirements. The authors suggest that manufacturers should use high-quality active ingredients, suitable formulations and packaging which comply with current Good Manufacturing Practices, in order to prevent stabilty problems occurring in drug products. In addition, proper storage conditions in accordance with the labelling should be strictly practiced in hospitals.
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Keywords
Stability problems, Non-essential drugs
Citation
Rakwatin Churairat, Nitysuddi D, Premjit L, Kovithvatta-naphong R, Wattanapisit Y, Tanunkat Orapin. Stability problems of non-essential drugs used in hospitals in Thailand. Siriraj Medical Journal, 1999 Jul; 51(7): 524-541.