DD-015 How should drug shortages be defined? a review

Abstract

Background Drug shortages are currently on the rise. In-depth investigation of the problem of drug shortages is necessary; however, a variety of definitions for ‘drug shortages’ are adopted by different organisations, e.g. Food and Drug Administration (FDA) and the American Society of Hospital Pharmacies (ASHP). For international comparison, it is important to clearly denote which definition is used by the national authorities or by (inter)national organisations. Purpose To identify and compare different definitions and analyse the overlap and missing info in each definition. Material and methods A literature review was performed searching the scientific databases MEDLINE and Embase for definitions of drug shortages. Grey literature, such as websites and documents of (inter)national drug agencies, was also incorporated. Results More than 15 different definitions for drug shortages were identified. Articles in the scientific literature often refer to existing definitions. Only a few articles describe their own definition. After comparison of the definitions some overlap was observed. Sometimes drug shortages are defined as situations in which a drug is undeliverable for a certain period; this period ranges from one day to 20 days. However, delaying treatment of infectious diseases for 20 days will have a serious effect on patients. Other definitions only consider those drugs used for the treatment of serious diseases or drugs for which no alternative is available; this underestimates the size of the problem. Conclusion The ultimate goal is to formulate a general European definition for reporting drug shortages, which is essential for international comparison. Indicating a time limit in the definition is an essential element for the comparison of nationally reported drug shortages. This time limit might be even one day if the patient’s health warrants it. A definition of drug shortages covering all types of drugs is crucial to acknowledge the size of the problem. References and/or acknowledgements No conflict of interest.