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FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy
A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy. The program is a collaboration among the U.S. Food and Drug Administration and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centers and Vanderbilt University.
About two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy according to a journal article published in the American Journal of Obstetrics and Gynecology. There are very few clinical trials that test the safety of medications in pregnancy due to concerns about the health of the mother and child.
“This program is a great example of FDA and the private sector working together to improve the health of pregnant women and their children,” said Margaret Hamburg, MD, Commissioner of Food and Drugs. "These data will guide regulatory policy and influence medical practice."
To overcome the challenges presented by the lack of clinical trial data about the use of medications during pregnancy, the research program will link health care information for mothers and their babies in each of the participating research sites. Collectively, the 11 participating sites have health care information for about 1 million births over the past seven years (2001-2007). Many of the mothers associated with these births likely used medication during their pregnancies and now, with the program in place, the FDA and participating researchers have a systematic and timely way of retrieving information from this network.
“This collaborative effort creates a unique resource to study the effects of medication in pregnant women and their children,” said Gerald Dal Pan, M.D., director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research. “Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy.”
The program blends clinical and research expertise and population-based databases from 11 health plan-affiliated research sites including Kaiser Permanente (Northern California, Southern California, Georgia,, Pacific Northwest, and Colorado regions); Harvard Pilgrim Health Care Institute, Group Health Research Institute, HealthPartners, Lovelace Clinic Foundation, the Meyers Primary Care Institute, and Tennessee State Medicaid, and the FDA. The HMO Research Network CERT Data Center at the Department of Population Medicine of Harvard Medical School and Harvard Pilgrim Health Care Institute, led by Richard Platt, M.D., M.S., is the coordinating center for the program.
Lead researchers include Susan Andrade, Sc.D. HMO Research Network William Cooper, M.D., M.P.H. (Vanderbilt); Robert Davis, M.D., M.P.H. (Kaiser Permanente Georgia); Craig Cheetham, Pharm.D.; (Kaiser Permanente Southern California); and De-Kun Li, M.D., Ph.D. (Kaiser Permanente Northern California). The investigators have collaborated on numerous studies related to medication use during pregnancy and birth outcomes, as well as studies on the effects of anti-depressant medications, antibiotics, and cardiovascular medications on birth defects and perinatal outcomes.
A Steering Committee composed of representatives from each participating site and the FDA will oversee MEPREP activities and provide overall scientific leadership. FDA epidemiologist, Pamela E. Scott, Ph.D., is the FDA project lead and chair of the Steering Committee
Website Address:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm195934.htm
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Please note that all Travel Nursing Opportunities listed on this New York Travel Nurses web site are subject to change. Please contact a Recruiter at New York Travel Nurses today at (888) 894-2900 to find out about the most current Travel Nursing opportunities that are available. RNs need the appropriate experience for all Travel Nursing Jobs that are offered on this site. The New York Travel Nursing Assignments listed within this site are all a minimum of thirteen weeks in duration. Once you agree to accept one of these New York Travel Nursing Assignments, your particular Assignment length of time and the hours will be guaranteed as part of a written Employment Agreement. This guarantee will make you comfortable that you are receiving exactly what you agreed to upfront. You cannot be cancelled during this thirteen week Travel Nursing Assignment due to a low patient census. This will enable you to budget your finances efficiently without worry. Once you complete one of these New York Travel Nurse Assignments you can elect to continue your travel adventure at another Hospital, or continue at the same Hospital if the staffing need continues. You may also decide to accept a permanent position with the Hospital if that is your desire. The choice is entirely yours. When you work as a Travel Nurse at one of the New York Travel Nurse Assignments listed within this site, you will receive a premium salary and top notch health, life and disability insurance. Health Insurance for these New York Travel Nurse Assignments is 100% company paid. Employee Life/AD&D Benefits associated with these New York Travel Nurse Assignments are $25,000. Dental, Vision and Prescription Benefits are included as part of the benefits package associated with each of these New York Travel Nurse Assignments. For all of the New York Travel Nurse Assignments listed within this site, there are no Networks (use legitimate caregiver of choice), and there is no Medical Underwriting. There is a comprehensive 401(k) Plan for all New York Travel Nurse Assignments that includes 100% Company Matching, Immediate Vesting and Immediate Eligibility. As an New York Travelling Registered Nurse for the Assignments listed here, YOU decide your what housing best suits you. You have the choice of free private housing or a monthly housing stipend to cover housing expenses that you incur during your New York Travel Nursing assignment. All New York Travelling Registered Nurses receive a generous bonus for any RN who is referred that accepts one of the New York Travel Nurse Assignments listed on this site.
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