Unlicensed medicines in Norway - Trends in sales and consumption of unlicensed medicines before and after the regulatory change in December 2014

Abstract

Background: Using medicines safe and effective is an essential part of the medicine safety agenda. An extensive and growing body of literature on the use of unlicensed medicines shows that the use of unlicensed medicines is related to increased incidence of adverse drug reactions. The use of these has not been reduced in spite of new regulatory approaches for medicine, and instructions from professional organizations. In December 2014, the Norwegian Medicines Agency introduced a regulatory change that entailed a medical justification when health personnel prescribe unlicensed medicine in Norway. The intention behind this was to prevent improper use and to emphasize the personal and legal responsibility of prescribing unlicensed medicines to patients. Objective: To analyze trends in price and consumption of unlicensed medicines in Norway before and after the regulatory change in December 2014. Methods: A linear time-series regression model with ordinary least square application was used to analyze the effect of the regulatory change, trends for all sales values and ATC codes. A data analysis was conducted to map how many units and daily defined doses there were of unlicensed medicines in the 1st level of ATC codes from 2012 to 2016. It was also used to examine whether sales per unit (per package) was decreasing per month. Results: The regression analysis reported a statistically insignificant effect on total sales, indicating that the regulatory change had no effect on sales. Moreover, it indicated that there was a significant effect on five out of fourteen ATC codes. It is however, difficult to say that the regulatory change was the sole reason for this. Causal inference from the method is limited because it is not possible to dismiss other explanations for the observed changes in time-series. Furthermore, there was an overall increase in sales, units and daily defined doses. Conclusion: There is no significant effect of the regulatory change on sales and consumption. Further research is necessary to understand how unlicensed medicines are used. Without a full comprehension of this, it is difficult to suggest policies and processes to ensure that unlicensed medicines are used correctly.