# Presentation: 693941

## DRUG PREGNANCY REGISTRIESJan Cragan, M.D.

- 1-800-336-2176					Antiretroviral Pregnancy Registry			Lamotrigine Pregnancy Registry 			Sumatriptan Pregnancy Registry 			Bupropion Pregnancy Registry
- 1-888-233-2334
- 	Antiepileptic Drug (AED) Pregnancy Registry
- 1-800-986-8999						Pregnancy Registry for VARIVAX

**Notes:**
And lastly, these are the contact numbers for the currently active registries of which I’m aware. If there are clinicians in the audience, we encourage you to call and enroll your exposed patients as early in pregnancy as possible. 

## DRUG PREGNANCY REGISTRIESStrengths

- Shift in industry focus toward actively monitoring for  adverse effects of drug use in pregnancy
- Prospective ascertainment reduces selection bias  and allows calculation of the risk of adverse outcomes
- Increased statistical power to identify defects resulting from individual drug exposures

**Notes:**
There are several strengths to this method. 

First and foremost, the pregnancy registries represent a shift in the focus of the pharmaceutical industry toward actively monitoring for adverse effects of drug use in pregnancy. Rather than assuming that their drugs are safe, the companies want to know if there is a problem. In my view, this is the most important result of the pregnancy registry activities and is evidenced by the increasing number of inquiries we get at CDC from companies about how to set up a registry.

Another strength is the prospective nature of the ascertainment, which reduces the selection bias inherent in adverse event reporting and allows calculation of the risk of adverse outcomes.

And, the pregnancy registries also have an increased statistical power to identify elevated defect rates resulting from individual drug exposures compared with other surveillance methods.

## DRUG PREGNANCY REGISTRIESLimitations

- Difficulty in obtaining sufficient sample size to evaluate changes in individual defect rates
- Lack of a control group
- Quality of exposure and outcome data
- Confidentiality issues

**Notes:**
* There are limitations to the registries. A primary one is the difficulty in obtaining a sufficient sample size to evaluate changes in individual defect rates, as we’ve just seen. The Acyclovir Registry enrolled 1695 prospectively exposed pregnancies in 14 years of data collection. That’s, on average, approximately 120 per year, clearly only a fraction of the actual exposures each year in the US. This is in spite of active promotional attempts by the company.
* Another problem is the lack of a control group. Defect rates among exposed pregnancies are compared to those published in the literature, frequently from Atlanta, the state-based surveillance system, or the Collaborative Perinatal Project. But the Glaxo Wellcome registries receive reports world-wide from any country where their drugs are marketed. We know there are racial and ethnic differences in some birth defects, and geographical variations between and within countries.
* Perhaps the greatest concern is with the quality of the exposure and outcome data. Currently, drug exposure is grouped by trimester. More precise timing of exposure would require detailed information and accurate assessment of gestational age. As a pediatrician, I question the accuracy and completeness of information about congenital defects reported solely by obstetricians. I’ll show you more about that in a moment.
* And finally, the issues of confidentiality of information, informed consent, and protection of human subjects have not been fully and uniformly addressed across the registries.

## CONSIDERATIONS FOR DEVELOPMENTOF A CENTRAL PREGNANCY REGISTRY

-  Definition of a central registry
-  Data to be collected
-  Administration and funding
-  Is a central registry worth the effort?

**Notes:**
And lastly, these are the contact numbers for the currently active registries of which I’m aware. If there are clinicians in the audience, we encourage you to call and enroll your exposed patients as early in pregnancy as possible.