A142: Implementation of a Quality Improvement Initiative to Reduce Unintended Fetal Exposure to Teratogenic Medications among Female Pediatric Rheumatology Patients

Background/Purpose: Pediatric rheumatology patients are frequently prescribed potentially teratogenic medications. The need for a standard process for counseling around teratogenic risks as well as screening for pregnancy was highlighted by a series of unintended pregnancies which occurred in teens on potentially fetal‐toxic medications at our institution. Our aim is to prevent unintended fetal exposure to teratogenic medications through implementation of a division wide REMS (Risk Evaluation and Mitigation Strategy) program for female rheumatology patients being prescribed high risk therapeutic agents. Methods: A literature search was performed to identify existing standards for REMS programs for teratogenic medications. An informal survey of pediatric rheumatologists was also conducted. Medications with high potential for fetal toxicity were identified through literature search and review of FDA and American College of Rheumatology guidelines. Commonly prescribed medications with FDA category D or X rating for teratogenicity in pregnancy (azathrioprine, cyclophosphamide, leflunomide, methotrexate, and mycophenolate mofetil) were selected for inclusion in the program. We developed a process that enrolls female rheumatology patients 12 years or older being prescribed a high risk medication in a protocol that encompasses education, contracting for safe use of medications, referral for contraceptive counseling, and regular urine pregnancy screening. Materials developed for this initiative included a provider script to help broach the topic of medication teratogenicity, a provider‐patient informed consent contract and information provided on clinic discharge paperwork. Implementation of the program was conducted through a series of staff training events. Results: Enrollment in the program commenced June 15, 2103. Preliminary results indicate that over an 11 month period almost 280 rheumatology patients met criteria for inclusion. Our primary outcome measure will be the number of unintended pregnancies among female rheumatology patients on high risk medications during the 12 months subsequent to protocol implementation. Process measures to be followed include percentage of at‐risk patients enrolled and compliance with recommended pregnancy screening. Barriers to enrollment and screening will be assessed through periodic staff surveys. Conclusion: This quality improvement effort is modeled after existing standards for teratogenic medications such as the isotretinoin iPledge program and the mycophenolate mofetil REMS program recently mandated by the FDA. Our process closely parallels the existing Seattle Children's Hospital protocol for pregnancy screening prior to imaging and surgical procedures. However, we believe this to be a novel quality improvement effort to standardize discussion of teratogenic medication risks and screening for unintended pregnancy in the ambulatory pediatric rheumatology setting. We hope our experience may benefit the broader community of pediatricians who grapple with the issues presented by prescription of highly teratogenic medications.