Leveraging electronic health records to notify pediatric patients of a drug recall.

Abstract

Drug recalls have become an unfortunately frequent event in the United States, with nearly 1 clinically relevant drug recall per month in the last 5 years.1 A national management strategy on medical device recalls is currently being debated by government and health officials.2 We report the use of the National Institutes of Health–sponsored Informatics for Integrating Biology &Bedside (i2b2) platform3 as an approach to speed patient identification and direct notification of a voluntary drug recall by leveraging data available in the electronic health record (EHR). On November 9, 2012, specific lots of the generic version of atorvastatin calcium, distributed by Ranbaxy Pharmaceuticals Inc, a subsidiary of a multinational corporation, were reported as possibly contaminated with “very small glass particles resembling a fine grain of sand.”4 A voluntary recall was announced by the company and reported to the general public by news organizations. A US Food and Drug Administration (FDA) notice on November 28, 2012, recommended that patients contact their health care provider with any symptoms related to taking the medication and health care providers report any suspected adverse events to the FDA. A team of physicians, a nurse practitioner, and a nurse who provide clinical care in the Preventive Cardiology program at Boston Children’s Hospital felt obligated to inform the pediatric patients prescribed atorvastatin and their families of the drug recall in a targeted and efficient approach to (1) identify those at risk and (2) prevent unnecessary discontinuation of beneficial treatment.