In medication counseling during pregnancy, a mobile application might be a way to provide healthcare professionals with immediate, reliable information on the risks of a mother’s drugs on her baby’s development.

A University of Washington and corporate partnership is exploring the feasibility of, and prototype for, such a mobile app.  To carry out this effort, RightAnswer.com, Inc., and a UW expert team have received a $150,000 Small Business Innovation and Research grant from the Centers for Disease Control and Prevention.  RightAnswer.com is a knowledge management software company.

The prenatal safety of over-the-counter and prescription drugs is a growing concern. In the past three decades, medication use during pregnancy has risen in America by more than 60 percent. Approximately 40,000 infants are born each year with birth defects from medication exposure.  This can be devastating for the children and their families.

Stopping medications during pregnancy, however, isn’t always an option, the mobile app team noted. Some medications, including those that treat epilepsy and cancer may be necessary for the mother but might cause problems for her baby.  In each case, she and her physician must weigh potential risks and benefits.

The lack of sufficient data makes it difficult for healthcare providers to assess the fetal health risks of some medications.  Risks might vary depending on dosage and how the drug is administered.  Also, risks can change as the baby forms.  Some drugs can affect the early stages of embryonic growth; others have no effect until later fetal development. 

Even when scientific evidence exists, health professionals find that obtaining that information to make a recommendation for a patient is not often easy. According to the Centers for Disease Control and Prevention, research databases with expert reviews and evidence summaries of fetal health risks for specific medications are not widely available to women and their health care providers. They are therefore under-used.  

The mobile app project members trying to solve this problem come from several fields of expertise.

Janine Polifka, manager of UW Department of Pediatrics The Teratogen Information System, heads the UW component. TERIS contains up-to-date, authoritative information about the effects of drugs and chemicals on prenatal development.  The database covers peer-reviewed scientific research on the safety or toxicity of more than 1,600 agents. Among them are about 95 percent of the most frequently prescribed medications.  TERIS’s review board of fetal toxicology experts evaluate the magnitude of risk for each agent listed.

To create a mobile app that fits with clinicians, Gary Hsieh, assistant professor of human centered design and engineering at the UW College of Engineering, will gather information requirements of healthcare providers who treat pregnant women. Their viewpoints will shape the specifications for the mobile application.

Joining Hsieh on the clinical usability trials and the app development is Carol Collins, clinical associate professor of pharmaceutics at the UW School of Pharmacy.  She has extensive experience in drug safety information and the design of drug safety databases. Collins has worked on the UW School of Pharmacy Drug Interaction Database and the University of Pittsburgh Drug Interaction Knowledge Base.

“Providing accurate and usable information to healthcare providers at point-of-care is very challenging,” she remarked. “We have to understand what the relevant questions are that healthcare providers have and address the challenges associated with providing information on the small screen format of mobile phones.”

The principal investigator for the Centers for Disease Control app development grant is Glen Markham, RightAnswer.com corporate business development executive.  Sarah Albee, director of IT at RightAnswer.com, is the project manager. RightAnswer.com specializes in data management for corporate, medical, pharmaceutical, government and international entities.

 “This project,” Markham said, “has the potential to enhance the assessment of clinical management options for pregnant women in ways that have never been done before.”