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The Vaccines and Medications in Pregnancy Surveillance System (VAMPSS)
A Collaboration Among:
American Academy of Asthma, Allergy & Immunology (AAAAI)
Organization of Teratology Information Specialists (OTIS)
Slone Epidemiology Center at Boston University (SEC)What is VAMPSS?
The Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) is a new nationwide post-marketing surveillance system established to comprehensively monitor the use and safety of vaccines and medications during pregnancy.Why was VAMPSS developed?
Major congenital malformations occur in 3-5 % of all infants, and other complications, such as preeclampsia, preterm birth and intrauterine growth retardation occur in 10-15 % of pregnancies. Although pharmacologic agents are uncommon causes of these adverse outcomes, they are among the most preventable. Because adverse effects of a drug during pregnancy are not predictable based on preclinical studies or drug class and pregnant women are not usually included in pre-marketing trials, post-marketing surveillance is required to establish the risks or safety of medications and vaccines during pregnancy. Unfortunately, no systematic surveillance system for this purpose exists in this country, and so there is a lack of adequate safety information for most pharmacologic agents taken by pregnant women. This lack of information leads to a number of potential adverse consequences.The major goal of VAMPSS is to provide the needed national systematic post-marketing surveillance system for pharmacologic therapy during pregnancy. With this system, we hope to identify as early as possible the circumstances in which a drug or immunization causes harm. In addition, we hope to provide reassuring data in a timely manner to all concerned for those drugs and immunizations (likely the majority) that are safe during pregnancy.
How is VAMPSS organized?
VAMPSS is coordinated by the American Academy of Allergy, Asthma & Immunology (AAAAI) and includes an Investigative Task Force and a standing independent Advisory Committee. The Investigative Task Force includes representatives from the AAAAI, the Organization of Teratology Information Specialists (OTIS), and the Slone Epidemiology Center (SEC) at Boston University. The Advisory Committee includes members from the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), American College of Obstetrics and Gynecology (ACOG), American Academy of Pediatrics (AAP), as well as a biostatistician and a consumer representative.Although VAMPSS activities are coordinated with relevant government agencies and professional organizations, VAMPSS represents an independent surveillance system serving the public and private sector. VAMPSS is currently supported through research grants from the U.S. Office of Biomedical Advanced Research and Development Authority (BARDA) and the Agency for Healthcare Research and Quality (AHRQ).
How does VAMPSS work?
What questions can VAMPSS help to answer?
How will VAMPSS information be used?
How can clinicians help support VAMPSS?
How can pharmaceutical companies work with VAMPSS to assess the safety of their medications during pregnancy?
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