2013 Annual Report: Representing the Interest of Otolaryngology Patient Safety and Quality Improvement (PSQI) with the Food and Drug Administration (FDA)
Last year, the AAO-HNSF was contacted by the FDA about its plans to issue a directive regarding the use of codeine post tonsillectomy and/or adenoidectomy. The PSQI Committee proactively emailed members once it was informed that the FDA was focused on this issue. The committee kept in touch with the FDA as it came out with an alert in August 2012 warning of the risk of possible fatality when codeine is used in these patients and when the FDA ultimately issued a black box warning and contraindications in February 2013. The FDA agreed to co-author a commentary with PSQI Committee co-chair, David W. Roberson, MD, and Executive Vice President and CEO David Nielsen, MD, which was published in the New England Journal of Medicine June 6, 2013 (http://bit.ly/NEJMdrug).
Last year, the AAO-HNSF was contacted by the FDA about its plans to issue a directive regarding the use of codeine post tonsillectomy and/or adenoidectomy. The PSQI Committee proactively emailed members once it was informed that the FDA was focused on this issue. The committee kept in touch with the FDA as it came out with an alert in August 2012 warning of the risk of possible fatality when codeine is used in these patients and when the FDA ultimately issued a black box warning and contraindications in February 2013. The FDA agreed to co-author a commentary with PSQI Committee co-chair, David W. Roberson, MD, and Executive Vice President and CEO David Nielsen, MD, which was published in the New England Journal of Medicine June 6, 2013 (http://bit.ly/NEJMdrug).