Pilot Project for a National Monitoring Systemfor Major Adverse Effects of Medication Use during Pregnancy and Lactation BACKGROUND The use of a number of medications during pregnancy is known to be associated with serious adverse effects in children. Thalidomide and isotretinoin (Accutane®) are the most notable examples, but there are others. Recent controversies surrounding the use of medications specifically to increase breast milk production have brought renewed attention to safety concerns about medication use during lactation. However, because pregnant and lactating women are traditionally excluded from clinical trials, and because premarketing animal studies do not necessarily predict the experience of humans, little information is available about the safety of most prescription medications during pregnancy and lactation at the time they are marketed. In addition, reproductive animal studies may not be conducted routinely for non-prescription drugs. While it is considered prudent to avoid taking medications when pregnant or breastfeeding, this is not always possible. Half of pregnancies in the United States each year are unplanned, so that many women inadvertently use medications early in gestation during the critical period of fetal development before realizing they are pregnant. In addition, many maternal conditions (e.g., asthma, epilepsy, depression) require treatment during pregnancy and breastfeeding, the cessation of which could pose a risk to the of both mother and infant. Currently, the United States has no early warning system for major adverse pregnancy or infant outcomes related to medication exposures. The U.S. Food and Drug Administration collects reports of adverse health events associated with medication use, but the extended length of time between many pregnancy exposures and outcomes makes underreporting a major limitation of this system for monitoring pregnancy outcomes. Adverse event reports are not routinely analyzed to assess pregnancy and lactation risk. Further, healthcare providers may be unaware that a woman is breastfeeding, and thus even less likely to report an adverse event related to lactation. Additionally, pediatric healthcare providers may not recognize breastfeeding as a potential source of medication exposure in a child. Because use of individual medications among child-bearing aged women can be low, it can take years for case control studies and birth defects surveillance systems to identify adverse effects of medications after they are marketed. Teratology Information Services (TIS) throughout the United States and Canada utilize trained specialists to provide free phone consultation, risk assessment, and counseling about environmental exposures during pregnancy and breastfeeding—including prescription and over-the-counter medications—to women and healthcare providers. TIS specialists research information about the effects of exposures during pregnancy and lactation from multiple sources (e.g., drug companies, the medical literature, other specialists). Altogether, they respond to approximately 70,000-100,000 inquiries each year. Because they have direct contact with pregnant and breastfeeding women, TIS are in a unique position to monitor the effects of medication exposures during pregnancy and lactation. A few TIS have conducted follow-up studies of pregnant women who contacted them after taking a specific medication. However, this type of monitoring of pregnancy and breastfeeding outcomes has never been conducted on a large scale. PURPOSE To collect data for use in assessing whether TIS in the United States can serve as an effective monitoring and early warning system for major adverse effects of medication use during pregnancy and lactation. SCOPE OF WORK Within a continuous six-month period (up to a maximum of 250 enrollees), the vendor will recruit all women who contact their service and who have used any prescription or over-the-counter medication during pregnancy or while breastfeeding to participate in a follow-up study. The vendor will explain the project and obtain informed consent from each participant to conduct telephone interviews. For each pregnant woman who agrees to participate, the vendor will conduct a telephone interview at enrollment, during the third trimester of pregnancy, after delivery, and when the infant is about 3 months old. For each breastfeeding woman who agrees to participate, the vendor will conduct a telephone interview at enrollment, at one month after enrollment, and, if the woman is taking a chronic medication and still breastfeeding, at 3 months after enrollment. The interviews will assess maternal and fetal health throughout pregnancy, and maternal and infant health at delivery, during the newborn and early infancy period, and while breastfeeding. The specific schedule for interviews is provided in Appendix A. The specific minimum data to be collected in each of the interviews is provided in Appendix B. This same information should be collected from all participants regardless of whether they enroll while pregnant or after delivery while breastfeeding The vendor should conduct each interview in a way that allows the information obtained to be combined with that from other TIS conducting similar follow-up activities under similar requisitions. NOTE: CDC IRB and OMB clearance has been submitted SPECIFIC TASKS TO BE PERFORMED Item# Item Description 1. Phone scripts for soliciting enrollment, consent forms for participation in the follow-up interviews, and questionnaires for use in each scheduled interview of pregnant breastfeeding women 2. Submit packet for local IRB approval 3. An interim summary of the project status each month for the first 3 months after enrollment begins, then every 3 months after that to include: - the number of pregnant and of breastfeeding women asked to participate in follow-up interviews each) - the number of pregnant and of breastfeeding women who consented to participate in follow-up interviews - the number of eligible pregnant and of eligible breastfeeding women who have completed each of the follow-up interviews - the number of pregnant and of breastfeeding women who declined to enroll in follow-up interviews and why they declined 4. A final summary of the project to include items in the interim summaries in addition to: - an anonymized data file with the values for each of the minimum data fields specified in Appendix B collected for each pregnant or breastfeeding woman - the proportion of missing values for each of the minimum data fields specified in Appendix B - the proportion of pregnant and of breastfeeding women who were willing to give consent for the TIS to contact the mother’s and infant’s healthcare providers for additional information (Note: no healthcare providers will actually be contacted) - the proportion of pregnant and of breastfeeding women who were willing to give consent for the TIS to obtain copies of their and their infant’s medical records (Note: no records will actually be requested) - the demographic characteristics of the women who actually participated in the follow-up (e.g., maternal age, race, ethnicity, education) - the reasons for not participating given by women who did not agree to participate in follow-up interviews - the number of full-time personnel who conducted the follow-up activities, including enrollment, interviews, data entry and analysis, administrative - the average number of hours spent in each phase of the follow-up activities, including enrollment, interviews, data entry and analysis, administrative VENDOR CONTACT INFORMATION University of North Texas Department of Biology Texas Teratogen Information Service Lori Wolfe, MS P.O. Box 305220 Denton, TX 76203-5220 Email:
[email protected] Phone: 800-733-4727 or 940-565-3892 DELIVERY SCHEDULE The vendor will either e-mail or send by Federal Express each item to the government reviewer no later than the following delivery dates: Item # Date 1. September 15, 2006 2. September 30, 2006 3. Within 30, 60, 90, 120, and 150 days of the date that data collection begins. The actual date that data collection begins will depend upon the date that all IRB and OMB approvals are obtained. 4. July 31, 2007 GOVERNMENT REVIEW OF PRODUCTS CDC will review the phone scripts, consent forms, and questionnaires as requested by the vendor. CDC will review all quarterly and final summaries upon delivery. Items should be delivered project officer noted below. PERIOD OF PERFORMANCE The period of performance shall commence upon award of a purchase order and shall continue through the next 12 months. However, an extension for an additional 12 months will likely be needed to complete follow-up interviews with all women who enroll. Note – this extension will be at no cost to the government. Note 22 (amended) “The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with two sources under the authority of FAR 6.302. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received by August 2, 2006 will be considered by the Government. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.” The approximate release date of the RFP on the FedBizOpps Website (http://www.fedbizopps.gov) is on or about April 17, 2006. The RFP due date will be approximately 30 days after posting of the RFP. The RFQ will be available upon request to the contract specialist via email. All questions/concerns about the RFQ package shall be submitted in accordance with the RFQ instructions via to
[email protected]. The NAICS Code for this requirement is 541720, and the size standard is $6.5 million. NO TELEPHONE REQUESTS FOR THE SOLICITATION WILL BE ACCEPTED. There is no plan to mail out hard copies of the RFP. IT IS YOUR RESPONSIBILITY TO KEEP UP WITH ADDITIONAL POSTINGS REGARDING THIS RFP ON THE FEDBIZOPPS WEBSITE.