Methotrexate is a widely used systemic medical product indicated for the treatment of cancer as well as for autoimmune diseases such as rheumatoid arthritis, psoriasis, and others. To inform their decision making regarding potential regulatory action, FDA seeks to understand the incidence and root cause of methotrexate wrong dosing frequency errors occurring in the United States. Between January 1, 2010 and December 31, 2016, FDA received 12 FDA Adverse Event Reporting System (FAERS) cases (including two deaths) associated with taking oral methotrexate at the wrong frequency—daily instead of weekly. Most of the cases did not provide the root cause of the error, making it difficult to identify targeted strategies to prevent these wrong frequency errors. The Institute for Safe Medication Practices (ISMP) has identified oral methotrexate as a high-risk medication that continues to cause fatal and harmful errors in patients, despite repeated warnings. (For more information, see the ISMP 2016-2017 Targeted Medication Safety Best Practices for Hospitals). The overall goal of this project is to improve Sentinel’s ability to identify wrong dosing frequency errors.
Michael Nguyen, MD; Jo Wyeth, PharmD; Efe Eworuke, PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD
Lisa Herrinton, PhD; Kaiser Permanente Northern California, Oakland, CA
Tiffany Woodworth, MPH; James Williams, MBA; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA