Background The Medicines Information Centre is contacted when medicine has been exposed to temperatures deviating from their specific standard storage conditions. In order to determine whether or not the medicine should be discarded, many factors have to be taken into consideration.
When lacking approved stability data, we must deduce and extrapolate from facts to make a ‘professional judgement’ (eg, can it be used conditioned by reduced shelf life?). This may result in variations in our case handling and hence conclusions.
There are a number of incentives which support investing time in finding a rational solution other than discarding the medicine (eg, a large number of medicine stored in the refrigerator are very expensive and we experience more frequent backorder situations). Handling a case of a medicine stored incorrectly can be resource consuming and therefore it is also relevant to find a balance between the time invested in case handling and the price of the medicine.
Purpose To develop a procedure which embraces tools and guidelines to ensure uniform quality and consistency in our decision making regarding a medicine stored under non-standard conditions.
Material and methods In addition to professional judgement, we have developed the following tools and guidelines to support the caseworker.
List of databases and sources of information retrieval:
local database of previous cases;
Micromedex and other databases on storage and stability;
A guide to use shelf life estimation methods (ie, when to use an equation to estimate the reduced expiration date).
De minims limit:
Obtaining a balance between resources spent on case handling and the cost of the medicine.
Results Over a 5 month period, 330 medicines were processed as having incorrect storage. In 186 cases (56%) only guidelines and tools were applied; in 85 cases (26%) guidelines, tools and professional judgement were applied; and in 59 cases (18%) only professional judgement was applied. All of the above mentioned guidelines and tools were applied in the cases.
Conclusion All of the guidelines and tools are important and useful in the case handling of incorrect storage of drugs, but they cannot stand alone in all cases. Professional judgement remains an essential element to complete the cases.
No conflict of interest.
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