Background
Topics & Panel
Video and PDF Presentations
Symposium's Published Proceedings
Background
Establishing a New Benchmark for Drug Evaluation during Pregnancy was the focus of the MOTHERISK UPDATE 2006 Symposium, which took place today during the Third Canadian Therapeutics Congress. The objective of this symposium was to review and discuss scientific and regulatory issues, challenges and solutions to ensure that pregnant women are not excluded from the benefits of safe and effective medications.
"Currently, pregnant women are deprived of advances in therapeutics due to misperception, anxiety of treating expecting mothers and litigious fears," stated Dr. Gideon Koren, Founder and Director of the Motherisk Program at the Hospital for Sick Children in Toronto. "Drug therapy used in pregnancy should be among Health Canada's top priorities as it affects both the pregnant woman and her fetus, with potential life-long effects on the unborn. It is the health authorities' responsibility to show leadership and a proactive role in taking all the necessary steps to ensure that pregnant women who require pharmacologic treatment for pre-existing or pregnancy-related diseases have access to proven safe medications."
"Forty-five years after the thalidomide disaster: where do we stand? Has this human tragedy resulted in a more rigorous and more responsible leadership from the Canadian Government in protecting maternal and fetal health?" While raising these questions, Mercédes Benegbi, from The Thalidomide Victims Association of Canada, noted that "Health Canada does not have a formal entity dedicated to and accountable for issues related to drugs in pregnancy.".
At the conclusion of this meeting, it was recommended that Health Canada develop a new drug review strategy and create a scientific advisory board responsible for providing advice and recommending guidelines on drug therapy in pregnancy and breastfeeding.
"This advisory board would include participation from government, professional medical organizations, industry and representatives of the public. It would play a critical role in ensuring that any drugs to be labelled for use during pregnancy undergo rigorous scientific and regulatory standards of safety and efficacy," stated Dr. Donald B. Davis, FRCSC, President elect of the Society of Obstetricians and Gynaecologists of Canada (SOGC). "The collection and analysis of data on fetal safety should be a key part of any drug review standards and/or guidelines aimed at safeguarding the health of pregnant women and their offspring. A post-marketing surveillance system should also be established in partnership with all concerned stakeholders," concluded Dr. Davis.
Topics & Panel
WELCOMING REMARKS
Dr. Stuart Macleod, CSCP
OPENING REMARKS
Dr. Gideon Koren, Motherisk
MODERATOR
Dr. Donald B. Davis, FRCSC, Society of Obtetricians and Gynaecologists of Canada
NIH NEW STRATEGY FOR DRUG RESEARCH IN PREGNANCY
Dr. Donald R. Mattison, National institute of Health (NIH/NICHD)
ISSUES IN USING DRUGS IN PREGNANCY: THE BALANCE OF SAFETY, RISK AND THE UNKNOWN
Dr. Gideon Koren, Motherisk
CHALLENGES IN DRUG USE NEAR TERM AND DURING DELIVERY
Dr. Dan Farine, Mount-Sinai Hospital
DRUGS USED IN PREGNANCY: THE REGULATORY PROCESS
Anne Tomalin, CanReg
COLLECTION AND ANALYSIS OF SAFETY DRUG DATA IN PREGNANCY
Myla Moretti, Motherisk
FORTY-FIVE YEARS LATER … WHERE DO WE STAND?
Mercédes Benegbi, Thalidomide Victims Association of Canada (TVAC)
Video and PDF Presentations
Establishing a New Benchmark for Drug Evaluation During Pregnancy
Symposium's Proceedings
The May 2006 Symposium’s Proceedings are now published in The Canadian Journal of Clinical Pharmacology, Vol. 14 (1), Winter 2007. at www.cjcp.ca/hm