The experience with medication errors associated with methotrexate in the United Kingdom very closely mirrors that recently reported in the United States. In July 2004, the United Kingdom's National Patient Safety Agency (NPSA) alerted the National Health Service (NHS) in England and Wales about the risks associated with oral methotrexate and issued a three-pronged strategy to combat those risks.
Annually, approximately 50,000 patients receive oral methotrexate treatment from NHS in England and Wales. One hundred thirty-seven patient safety incidents were reported during a 10-year period (1993-2002), of which 25 resulted in death and 26 in serious harm requiring hospitalization. Overall, 67% of the reported errors involved an overdose of the drug, usually because an intended weekly dose had been prescribed as a daily dose. A further 19% were due to a lack of clinical management and failure to perform the required tests. A third group of errors, accounting for 7% of the total, involved misidentification of the drug and other problems associated with product packaging and labeling. The most frequent indications for methotrexate were rheumatoid arthritis (75%) and psoriasis (17%). Patients for whom safety incidents were reported had a mean age of 59.8 years (range, 17-82 years). The mean ± S.D. number of concurrent prescription medicines was 7.7 ± 4.2.
A safe medication pathway was described by NPSA and populated with information about the incidents. This served to identify the critical stages in the pathway by employing a simple risk-assessment process: likelihood of occurrence versus severity of outcome for the patient. Finally, the process was used as a robust and impartial tool to identify potential patient safety solutions for development.
The findings for safe medication practice were that there should be better-informed patients, better-informed and supported clinicians, greater clarity of monitoring responsibilities, and more easily distinguishable tablet packaging with clear warnings. As Moore et al. also report, these safe practice recommendations have previously been made by ISMP. Rather than repeat the recommendations, however, NPSA has developed, tested, and now launched three strategies to prevent harm and support NHS in the safer use of oral methotrexate:
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NHS is expected to fully implement these measures by March 2005, with each health care organization being responsible for reporting completion. NPSA has now embarked on a program for evaluating the impact and outcomes of the patient safety alert.