Monitoring Process for Pregnancy Category D or X Medications in Women of Childbearing Age Jody L. Lounsbery, PharmD, BCPS, Barbara Leone, MD University of Minnesota North Memorial Family Medicine Residency Program The residency program clinic’s patient population includes a significant number of women of childbearing age. Many of these women have a higher incidence of chronic diseases at a younger age than expected with the general population. This, combined with a high number of unplanned pregnancies within the clinic’s patient population, created a need to identify women at risk and to provide appropriate patient education on the potential risks of common medications during pregnancy. The purpose of the project was to develop a process to identify and monitor the use of common Pregnancy Category D or X medications in women of childbearing age. Discussion Results Purpose References Methods The limitations of the EMR reports highlighted the need for improvement in data retrieval of documented contraception. The time to retrieve the reports from the EMR and to distribute to the providers was an issue. By the time the patient lists were distributed to providers for assessment almost three months had passed, possibly providing inaccurate information. The need to follow up with providers on their patient reports to ensure patients were assessed for need of further action was a barrier. Some of the providers did not return their reports and a tracking mechanism was found to be needed to ensure follow up. The results of the reports indicate the need for additional resident and patient education on the use of medications in women of childbearing age, particularly for those who have a greater likelihood of having an unplanned pregnancy. Conclusions Clinical pharmacy services in outpatient practices serve important functions of patient safety and education. This project highlights one such model of ongoing surveillance and aids in active panel management. The quality process that was used for Pregnancy Category D or X medications could also be applied to medication alerts and drug label changes. The next phase of monitoring will include an expanded list of pregnancy category D or X medications and additional cross-referenced contraception methods. It was determined to review the population of childbearing (ages 12 to 50) female patients who were taking any of the 10 Pregnancy Category D or X medications on the triage refill protocol: atorvastatin, pravastatin, fluvastatin, simvastatin, lovastatin, paroxetine, atenolol, lisinopril, lisinopril/hydrochlorothiazide, and losartan. Reports were collected from the clinic’s electronic medical record (EMR) for the timeframe 2010 to October 20, The patient lists were then cross- referenced against any forms of contraception also being used. Forms of contraception included any hormonal contraception (oral, intradermal, intramuscular, or intrauterine) and copper intrauterine devices. These reports did not account for patients who were not sexually active, were postmenopausal, or had undergone some form of sterilization. Providers were given a list of their patients who were on Pregnancy Category D or X medications and who were not on any form of documented contraception. Providers were asked to contact those patients either by phone or by standard scripted letter to discuss the potential risks. Once patients were addressed, each provider was asked to return his or her report to the pharmacy team with comments of actions taken. Pharmacy requests EMR report Pharmacy sends to providers, creates provider instructions, and drafts EMR letter template Instructions include: EMR letter template, timeline for completion, place for provider initials upon completion, and where to return patient lists Provider instructions are coupled with EMR patient lists and placed in panel management folders Action by providers to address patient lists will be taken in no more than 4 weeks Pharmacy creates spreadsheet to track patient lists After deadline, Medical Director contacts providers who have not addressed patient lists Final records kept and managed by clinic's Patient Care Supervisor Figure 1. Pregnancy Category D or X Medication Monitoring Process Figure 2. Patients (n=224) Prescribed Pregnancy Category D or X MedicationsFigure 3. Contraception for Patients Prescribed Pregnancy Category D or X Medications