Program Promotes Safer Teratogen Use in Pediatric Rheumatology

By Will Boggs MD

March 06, 2019

NEW YORK (Reuters Health) - A new program has improved patient education about potentially teratogenic treatments and increased pregnancy screening in a pediatric rheumatology clinic, researchers report.

"Keys to successful implementation of a program like this one include engagement of a multidisciplinary team and building on early gains achieved through simple interventions while developing tools for sustainment in the electronic health record (EHR)," Dr. Ashley M. Cooper from Children's Mercy Kansas City, Missouri, told Reuters Health by email.

Many drugs used to treat rheumatic disease have known or suspected teratogenic potential, but there is no standard for educating patients about that risk or screening for pregnancy in women of reproductive age, Cooper and colleagues note in Pediatrics, online March 5.

Nearly half of adolescents report a history of sexual intercourse, but only 57% of those report using condoms and 27% report using another form of contraception, the researchers add.

Dr. Cooper's team tried to increase pregnancy screening and teratogen education by applying mandatory Risk Evaluation and Mitigation Strategy (REMS) practices to all teratogenic medications prescribed in their pediatric rheumatology clinic. They aimed to document education and screening for pregnancy in 90% of eligible patients.

The researchers tested seven interventions through iterative plan-do-study-act cycles: medication list, provider education, nurse education, monthly updates, clinic preparation checklist, EHR education template, and standardized previsit planning.

In the eight months before the intervention, 24.7% (54/231) of eligible patient encounters had teratogen education documented, and 20.3% (47/231) had pregnancy screening performed.

In the 23 months after the first intervention, 79.6% (904/1,135) of eligible patient encounters had teratogen education documented, and 82.8% (940/1,135) had pregnancy screening performed. Both increases were statistically significant.

The first meaningful increase for both measures occurred after the three education-based interventions (from 34.7% to 87.6% teratogen education and from 31.8% to 86.2% pregnancy screening), and both measures increased to 95% after implementation of the final intervention.

During an additional year of follow-up, rates of education and pregnancy screening were consistently 90% or greater.

Three pregnancies were identified after the project began, all of them identified through the screening process, and the potentially teratogenic medication was stopped immediately.

"At the start of the project, our team was uncertain about how pregnancy screening in our teenage patients would be perceived by parents, but families were almost universally accepting of this new process and many expressed appreciation for the team's commitment to safe prescribing of teratogenic medications," Dr. Cooper said.

"As there is no universally established standard for pregnancy screening in adolescents taking teratogenic medications, our clinical team defined and later revised our local screening program," she said. "The optimal approach to screening to mitigate risk in a cost-effective way remains to be defined."

"Simplified methods for sharing EHR tools across institutions would streamline efforts to spread the success of local quality improvement projects," Dr. Cooper added.

Other experts praised the new program in emails to Reuters Health.

"Avoiding unplanned pregnancies occurring during therapy with teratogenic drugs is a responsibility of health care providers and necessitates structured interventions," said Dr. Monika Ostensen from the National Service for Pregnancy and Rheumatic Diseases and Norwegian University of Science and Technology (NTNU), in Trondheim, Norway.

"I think this is an excellent approach," she said of the new program, but "it may be seen as time-consuming and additional work."

Dr. Rebecca E. Sadun from Duke Health, in Durham, North Carolina, who recently reported the success of a similar intervention among adult women receiving teratogenic medications in a rheumatology clinic, said, "This is important quality-improvement work. It shows how poorly we do at baseline, especially in pediatrics, at addressing the risk for unintentional pregnancy in women on teratogenic medications. This paper also demonstrates that the implementation of series of inexpensive interventions can significantly improve pregnancy screening and contraception counseling in a population at risk for high-risk pregnancies."

"One of the problems at hand is that so many medical professionals see pregnancy prevention as someone else's job," she added. "The subspecialist may assume this is the job of the pediatrician who has more familiarity with prescribing contraception, while the pediatrician assumes this is the job of the subspecialist who has more familiarity with the teratogenic medication. Really, contraception counseling in pediatrics is everyone's job."


Pediatrics 2019.