ARTICLE IN BRIEF
Investigators reported that in nearly 50 percent of cases, epileptic women of childbearing age were not counseled about antiepileptic drug treatment effects on contraception and pregnancy nor counseled about the benefits of taking folic acid, according to available electronic medical records.
Doctors caring for epilepsy patients during the childbearing years are aware of the serious risks that many of the antiepileptic drugs (AEDs) have on the developing fetus. Epilepsy and pregnancy registries have offered researchers and doctors a critical window into the risks of individual medicines, and the information is now used to guide decisions for birth control and use of safer antiepileptic drugs in patients wanting children.
But is the information being documented in the electronic medical record (EMR), and would that information (and documentation) help in reducing the risk of malformations and other adverse events? A team of scientists studied EMRs to see whether there was documentation that women of childbearing age were taking a daily dose of folic acid and were using contraception. In particular, they looked at young women taking valproic acid, the antiepileptic drug that has been linked to the highest risk of fetal malformations. They wanted to know — from looking at EMRs — whether women were properly counseled about the risk for fetal abnormalities caused by valproic acid (VPA), the importance of contraception, and the need to take folic acid in the event that they should get pregnant.
Paul C. Van Ness, MD, director of the University of Texas Southwestern Epilepsy Program, and his colleagues reviewed 6,884 records at an outpatient EEG lab at three hospitals that serve his patients — two at the University of Texas Southwestern and at Parkland Memorial Hospital. They reviewed records from 2010 to 2012 for women taking VPA who were born between 1968 and 1996. The EMR was reviewed for use of contraception and/or folic acid at the time of the EEG.
Dr. Van Ness said that if they did not find it easily in the EMR they looked to the notes to see if the women were counseled on the risks of birth defects. He said that neurologists documented this information — use of contraception and folic acid and/or a discussion of the risks of birth defects — about 66 percent of the time in the EMR compared with 38 percent of non-neurologists (obstetricians/gynecologists or family doctors). There is a ten percent risk of a serious malformation among pregnant women taking VPA, he noted.
If women were surgically sterilized, there was no need for folic acid supplementation. Abstinence was considered a form of contraception, but folic acid supplementation was considered necessary in such cases or in cases with other forms of contraception, said Dr. Van Ness. They looked for notes in the EMR that suggested women were told about the risk of VPA.
There were 76 EEGs in 53 women taking VPA at the time of their EEG. Thirty-one of the 53 women were appropriately taking folic acid and 36 of 53 had EMR-documented medical/surgical contraception or abstinence. Overall, 25 of 53 (47 percent) women taking VPA had both adequate contraception and appropriate folic acid supplementation.
“We need to get better at documenting these discussions with our patients,” he added. “This is fairly simple to fix and it should be easy to document this in the EMR.” Dr. Van Ness is now working with pharmacists in his hospital to see if warnings could be built into the medical record for woman of childbearing age taking VPA, and to link that information to contraception use and folic acid supplementation.
“Some women need to stay on these drugs, even with the greater risk of fetal malformations,” he said. “But doctors have to ensure that they are safe and that if they get pregnant their babies are safe as well.”
The AAN Epilepsy Quality Measures, published in Neurology in 2011, recommend that women, 12-44 years of age, should be counseled about antiepileptic drug treatment effects on contraception and pregnancy. In this study, reported at the AAN annual meeting, half the time the standard was not met, said Dr. Van Ness.
“Our study suggests that there is a lot of room for improvement in documenting appropriate care,” said Dr. Van Ness. “It is impossible to know whether women were counseled or using folic acid supplementation or contraception as it might not have been entered into the EMR. But our findings suggest that we need to keep record of how are patients are being monitored during the childbearing years.”
Studies have shown that folic acid supplementation taken before pregnancy reduces the risk for neural tube defects in the developing fetus. What's more, contraceptive drugs can impact seizure medications and women should be educated on the risks of the medications they are taking, or be switched to ones that are safer for women of childbearing age.
EXPERTS WEIGH IN
“Paul Van Ness and colleagues draw attention to a very important issue: contraception and folic acid use in women with epilepsy taking VPA since VPA is associated with a several fold increase in fetal malformations,” said Andrew Herzog, MD, a professor of neurology at Beth Israel Deaconess Medical Center and director of the neuroendocrine unit. “Unintended pregnancies are also associated with a higher rate of adverse outcomes. While the findings that only the minority of cases (47 percent) was documented as having contraception and folic acid supplement could be a documentation deficit, the issue is important enough to be documented and documentation would make compliance with counseling more likely to occur.”
Lewis B. Holmes, the director of the North American AED Pregnancy Registry and a professor of pediatrics at Harvard Medical School, said that while it is important to protect against birth defects, there is no definitive proof that folic acid supplementation in woman taking valproate will reduce the risk for spina bifida, as it has been shown to do in the general population of pregnant women. “Of course, we hope it does, but we just don't know.” He said that he has seen new mothers give birth to a baby with spina bifida and they said that they had been taking folic acid supplementation well before they got pregnant.
Jacqueline French, MD, a professor at the NYU Comprehensive Epilepsy Center, said that “planning for pregnancy has to be done with a lot of prior thought. It is now clear that women with epilepsy should be counseled about the risks of malformations to the developing fetus. Even if there is a small risk, we need to do everything we can to prevent bad outcomes.” She added: “all women of childbearing age should be encouraged to take folic acid.”
For additional commentary on the study and its ramifications, watch the brief video with Dr. French: http://bit.ly/aNQ4KB.
TUNE IN: EPILEPSY: Are neurologists discussing folic acid supplementation and contraception with women of childbearing age? What the electronic medical records suggest: A new AAN annual meeting report found that in nearly half of cases, there was no documented discussion in electronic medical records showing that women had been counseled about the risks of taking valproic acid; nor was there was there mention of the importance of taking folic acid. In a video interview, Jacqueline A. French, MD, professor of neurology at New York University Comprehensive Epilepsy Center and president of the American Epilepsy Society, discusses what this can mean for clinicians seeing women with epilepsy of childbearing age: http://bit.ly/aNQ4KB. Dr. French is a member of the NeurologyToday editorial advisory board.
A ‘BEST PAPER’ PICK:Neurology Today editorial advisory board member Jacqueline A. French, MD, professor of neurology at New York University Comprehensive Epilepsy Center and president of the American Epilepsy Society, selected this as one of the “best papers” on epilepsy from the AAN annual meeting.
•. AAN annual meeting abstract (2013): AAN epilepsy quality measures: Electronic medical record documentation of folic acid and Contraceptive Method Use in women of childbearing age taking valproic acid referred for electroencephalography: http://bit.ly/Z00ruw
•. Fountain NB, Van Ness PC, Bever CT, et al. for the American Academy of Neurology Epilepsy Measure Development Panel and the American Medical Association-Convened Physician Consortium for Performance Improvement Independent Measure Development Process. Quality improvement in neurology: AAN epilepsy quality measures. Report of the Quality Measurement and Reporting Subcommittee of the American Academy of Neurology. Neurology. 2011; 76:94–99.
•. The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs Study: http://bit.ly/1126bCQ