Impact of safety-related regulation on use of parenteral ketorolac in a nationally representative population

Abstract

Objectives The objective of this study was to evaluate the impact of a regulatory action on use of parenteral ketorolac issued by Taiwan's Food and Drug Administration due to concern of its adverse events in a nationally representative population. Methods The data source of this study was the 2006–2010 Taiwan's National Health Insurance Research Database. The study employed a before–after design with a preregulation period consisting of a 2-year control phase (1 July 2006 to 30 June 2008) and a postregulation period (1 July 2008 to 30 June 2010). Monthly claim data on prescriptions of parenteral ketorolac during both periods were analyzed. Demographics of patients who received ketorolac and their prescribing physicians were examined. Key findings The percentage of nonpostoperative use against the restriction among inpatient prescriptions for parenteral ketorolac decreased from 27.44% in the preregulation period to 24.63% in the postregulation period (P < 0.01). Nevertheless, more than 90% of outpatient prescriptions for parenteral ketorolac in the pre and postregulation periods were nonpostoperative use. Conclusions Our unique medical care system under the National Health Insurance programme allows us to provide empirical evidence regarding the effect of safety-related regulations when patients have free access to medical care, which is seldom discussed in current literature.