For newly introduced medicines a structured pregnancy surveillance program can be of significant importance to ensure the safety of the pregnant woman and the fetus. In addition it can help ensuring that a medicine is not blamed incorrectly for damages during pregnancies because of too little information.
When a product it introduced on the market usually very little is know about the potential for the drug to cause fetal harm. There will be some preclinical studies in animals giving some hints, but in reality there is often a huge difference between animal finding and subsequent effect on humans.
For most drugs the fetal risk will be very low, but even a few incidents where the drug cause fetal harm can result in a withdrawal of the product from the market – or severe restrictions. If such decision is based on only the events themselves there is a high risk that a withdrawal decision may be wrong and this is where the modern structure pregnancy surveillance programs are helpful.
A well structured pregnancy surveillance program for a new medicine is based on two components
1. Detection of very rare events in databases with high number of pregnancy outcomes registered
2. Detection of small differences in adverse events/outcomes between exposed and non-exposed pregnancies
One of the most prominent institutions currently undertaking independent surveillance programs is the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) which is a collaboration between American Academy of Allergy Asthma and Immunology (AAAI) the Organization of Teratology Information Specialists (OTIS) Research Center at the University of California San Diego, the Slone Epidemiology Center (SEC) at Boston University and the Harvard Pregnancy Research Group.