Pregnancy Registries: Increasing Safety and Access

Pregnency registries UBC

Pregnancy Registries: Increasing Safety and Access

Understanding the effects of medications in pregnant women is a public health need that continues to require the highest level of services our industry can provide.

Women of childbearing age have a wide range of medical conditions that require chronic therapy such as diabetes, depression, epilepsy, and asthma. If they become pregnant, they must also face questions regarding the potential impact of their medication on the risk of birth defects.

Those who seek materials regarding these risks are often disappointed by the lack of specific information available in most product labels and from medical information sources.  This lack of information is particularly daunting for women of childbearing age who live with a cancer or rare disease diagnosis, as the dearth of available data regarding birth outcomes following treatment are particularly absent for medications in these areas. Too often as they consider becoming pregnant, women must make these choices with little to no data-based information related to the potential effects the medication may have on their ability to conceive or on the health of offspring.

While useful observational data have been systematically collected for some drug classes such as antiretroviral and antiepileptic medications, many important drugs and biologics, including those used to treat cancer or rare diseases, have very limited available information. To fill the knowledge gap, investigators or sponsor companies may choose to either begin new registry studies or use large administrative databases that have both prescription drug use and birth outcome information.

Proactive Registry Design and Planning

A pregnancy registry is an organized, prospective, observational, longitudinal study designed to estimate the overall risk of birth defects, and in some cases, the risk of infant developmental delays, associated with a particular drug.  Pregnancy registries exist both for specific medical conditions, such as HIV/AIDS, cancer, and epilepsy, as well as for specific products used to treat these conditions and other common conditions such as type 2 diabetes, multiple sclerosis, and rheumatoid arthritis. Both the European Medicines Agency and Food and Drug Administration have issued guidelines on when it is appropriate to conduct a pregnancy registry. These guidelines include:

  • When the medication has a high likelihood of being used in women of childbearing age
  • When the medication is for chronic therapy use and it is unadvisable to discontinue the therapy during pregnancy
  • When the medication has special circumstances, such as the potential for fetal infection through administration of live attenuated vaccines
  • When animal studies or human case reports have shown the potential for fetal harm
  • When the medication belongs to a drug class or has similar components or mechanisms of action as drugs known to have teratogenic effects

Well-designed registries should include processes to ensure patients receive appropriate follow up communications and outreach to collect data related to birth outcomes.  Too often registry procedures do not adequately address gaps in patient reporting. Data that could be collected and used in safety reports is left pending.

Pregnancy registries are an important method of research to learn more about a product’s potential effect on birth defect risks.  Other methods, including database analyses, also are used. Still, safety data collection in pregnant women lags behind safety reporting for other patient populations. Increased vigilance in this area is needed to better understand potential risks while also improving access to medication.   As with all observational studies, pregnancy registries must be conducted with great care in design, conduct and analysis.  Well-designed and documented pregnancy exposure registries hold promise of contributing greatly needed knowledge, allowing prescribers to best advise their patients and helping pregnant women make better-informed decisions regarding the best therapeutic choices during pregnancy.

Join UBC at the DIA 2015 51st Annual Meeting. I will join regulatory experts from the EMA and FDA to present, “Developing Innovative Approaches to Postmarketing Safety Data Collection in Pregnant Women, ” a panel discussion exploring the challenges of conducting postmarketing studies in pregnant women.

 

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