Background/Purpose: Many women of childbearing potential with autoimmune diseases require terotogenic medications, such as mycophenolate. On October 29, 2007 the FDA deemed mycophenolate a pregnancy class D medication given the risks of first trimester abortion and congenital malformations.¹ The encounter when mycophenolate is initiated is arguably the most important time to counsel patients on its risks and the need for effective contraception. We compared reported rates versus actual documentation of counseling in the electronic medical record (EMR).

Methods: We developed a 10 question, anonymous survey that was distributed to all rheumatology providers at our institution. The survey asked respondents at how often they provide and document adequate counseling when initiating mycophenolate in women of childbearing age. Subsequently, using our institution’s De-identified Clinical Data Repository, we identified women aged 17-45 on mycophenolate who had been seen in one of our rheumatology clinics since October 29, 2007, and assessed actual documentation of counseling at initiation of mycophenolate.

Results: Fifteen faculty and fellows (83%) responded to the survey. On average, respondents reported providing and documenting adequate counseling when initiating mycophenolate in 74% and 64% of encounters, respectively. Of 219 charts reviewed, 65 patients met inclusion criteria; the patients included were predominately Caucasian (38%) with an average age of 35. In 5 encounters (8%) providers documented advising the patient that mycophenolate is a teratogen and in only 1 encounter did a provider discuss the specific risks (Table I). The need for contraception while taking mycophenolate and 6 weeks afterwards, as well as the type of contraception utilized were also scarcely documented (n=6, 9%; n=0, 0%; n=9, 14%, respectively). In 22 (34%) encounters providers documented discussion of other side effects or that information was provided. Barriers to effective counseling identified by the survey included lack of time (50%) and inadequate knowledge (33%).

Conclusion: Documentation of counseling on teratogenicity and the need for contraception at the initiation of mycophenolate was reported at much higher rates than was actually observed on chart review, despite higher documentation of other side effects. By educating providers and using the EMR to prompt them to provide counseling when prescribing mycophenolate, we may be able to increase documentation rates. Additionally, “dot phrases” with risks and contraception information could be imported into the provider note and patient instructions as a time saving strategy. Table I. Mean reported rates of counseling on the teratogenicity of mycophenolate and the need for contraception as compared to actual documentation of counseling

References: 1. U.S. Food and Drug Administration. (2007, October 29) Cellcept (mycophenolate mofetil) October 2007. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152095.htm. (Accessed 1/3/2016)

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/discrepancy-in-reported-and-actual-rates-of-counseling-on-teratogenicity-and-the-need-for-contraception-when-initiating-mycophenolate-in-women-of-childbearing-age/