Patient Safety: Adverse Drug Events in a Regional Hospital

The University Hospital of Jaén (Spain) has 785 beds and a reference population of 292,633 inhabitants. During 2007, there were 25,459 admissions, with average hospital stays of 8.52 days. In this year, a prevention program of adverse events due to medication at the hospital was designed. Initially we determined the frequency of adverse events from medication, analyzed the causes, and implemented a risk management program for the prevention of these adverse events. Finally, we assessed the effectiveness of the program.

First we established a quality improvement group at the hospital, then we selected its members and defined their responsibilities. The last stage included the analysis and evaluation of the resulting state of affairs. At the same time, we programmed a schedule of milestones. For the analysis of problems, various quality tools were used, including Root Cause Analysis (RCA) and Failure Mode and Effects Analysis (FMEA).

After applying the methodology mentioned above, the research team measured the effect of the change in adverse events due to medication. In the various phases of the therapeutic chain, the following proportions of adverse drug events appeared: prescription 46.38%, monitoring 32.11%, and administration 12.64%. At this point, the clinical risk management model proposed by the Australian Patient Safety Foundation was initiated. This model included the analysis of the context as well as the identification, analysis, and evaluation of risks. After program implementation, the overall frequency of adverse events due to medication drop from 6.53% to 2.01% (p <0001). After the implementation of the program, we found that adverse reactions to medications showed no statistically significant decrease (0.38% to 0.32%), preventable adverse events went down from 1.57% to 0.89% (p <0.01), the potential adverse events declined from 2.11% to 0.41% (p <0001), and trivial medication errors decreased from 2.47 to 0.39% (p <0001).

The implemented program identified security problems, developed improvement measures, and quantified the results achieved. In addition, the project proved to be a successful experience that motivated the implementation of a regular system for measuring and controlling new security risks and resolving those already identified.