A quality improvement project to incorporate the mycophenolate Risk Evaluation and Mitigation Strategies in an academic lupus clinic

Abstract

Background/Purpose

Mycophenolate compound (MMF, to represent both mycophenolate mofetil and mycophenolic acid) is an immunosuppressant used to treat Systemic Lupus Erythematosus (SLE). Due to its teratogenicity, the FDA recommends universal mycophenolate Risk Evaluation and Mitigations Strategies (MREMS) to prevent unplanned pregnancies and minimize fetal exposure. This quality improvement initiative aimed to improve documentation of the MREMS protocol in the encounter clinic note from 0% to 75% within 14 months.

Methods

The project was conducted in an academic lupus clinic from February 2023 to May 2024, with the intervention beginning in March 2023. MREMS was recommended for adult female SLE patients aged 18–50 on MMF, excluding those with hysterectomy. Interventions included provider and nurse education, nursing algorithms for identifying eligible patients and ordering pregnancy tests, electronic health record template updates, and regular feedback. Required documentation included counseling on MMF teratogenicity and contraception, with pregnancy testing at each visit. Control charts monitored documentation of MREMS counseling and pregnancy testing, and a one-year post-implementation follow-up was completed.

Results

Among eligible encounters (n = 89), MREMS documentation increased from 0% to an average of 24% during the first 8 months of PDSA cycles, then shifted to an average of 67% of encounters. We reached and sustained our documentation goal of 75% for the last three consecutive months. Pregnancy-test ordering rose from 0% to 63%, and contraception was documented at 98% of visits. Over the course of the intervention, no pregnancies were exposed to MMF. MREMS documentation and pregnancy screening remained above 75% of encounters 1 year after intervention.

Conclusion

Using quality improvement cycles, we incorporated a two-part MREMS protocol into a busy academic lupus clinic, with improved documentation and pregnancy screening.