Using human factors methods to evaluate the labelling of injectable drugs.

Adverse drug events, including in-hospital medication errors, are a well-documented world-wide problem. This interdisciplinary team set out to examine the issues related to the labelling of injectable drugs. We sought answers to the following two questions: (1) To what extent do injectable drug labels adhere to existing Canadian design practice recommendations and regulations for labelling and (2) is there a need to make changes to the recommendations or regulations for labelling of injectable drugs in Canada? The project contained three phases. The first phase involved taking a sample of vials and ampoules from a hospital pharmacy and identifying adherence to the 1999 Canadian Standards Association standard for the labelling of drug ampoules, vials and prefilled syringes, as well as with the Canadian (Health Canada) Food and Drug Regulations for labelling. The second phase involved a failure mode and effects analysis of the label-reading process in order to identify information on the label considered critical for safe medication use. The third phase involved a preliminary human factors experiment addressing one problem identified with existing labels. Our finding is that existing injectable drug labels do not adhere sufficiently to available best design standards for labels and also do not adhere to all Canadian Food and Drug Regulations. Recommendations are made to inform future enhancements to labelling standards, guidelines and regulations.