Aim: Drug product changes occur in hospitals for different reasons: improved efficacy or tolerance of a drug, reduced costs, new pharmaceutical innovations or drug shortage. The aim of this analysis is to develop a process model for drug product changes and to determine a hospital specific threshold when product change is reasonable, provided that the efficacy and safety of the new product is economically reasonable. Methods: The individual process steps at the Klinikum rechts der Isar in Munich (MRI) were recorded to develop a process model. The required expenditure of time for the different process modules was documented and a process cost calculation undertaken. Results: Product changes can be divided into three groups: generic changes, identical active ingredient but different brand name, and complex drug changes with different active ingredients or changed drug formulation. The latter change is associated with a higher demand for information, which is reflected in higher process costs. Relevant costs arise during the process of product purchase and on the ward. The cost per product change inclusive operating expenses at the MRI range from 2,300.- epsilon to 6,420.- epsilon and depend on the frequency of prescription and the complexity of the product. Conclusion: This Health Technology Assessment shows that main costs for a drug product change arise due to additional staff costs on the ward. Reasonable thresholds can aid in decision making when considering cost effectiveness and potential risks of the medication or patient safety.
