June 2010 Pregmedic Symposium
Background
Topics & Panel
Video and PDF Presentations
Symposium's Published Proceedings
In 2006, the Motherisk Program held a symposium entitled Establishing a New Benchmark for Drug Evaluation during Pregnancy. The objective of this symposium was to review and discuss scientific and regulatory issues, challenges and solutions to ensure that pregnant women in need of drug therapies could be safely treated.
Following this symposium, individuals from various backgrounds: healthcare professionals, academics, patients, regulators and representatives from the pharmaceutical industry, considered this topic of such importance to create the organization Pregmedic - The Canadian Alliance for the Safe and Effective Use of Medications in Pregnancy and Breastfeeding.
In the subsequent years, the Canadian government recognized pregnant women and their fetuses to be a vulnerable patient population group. This was a huge step forward. However, healthcare professionals and patients still struggle to find current and reliable information on which they can base their decision to use a medication during pregnancy and breastfeeding. This became clear during the HINI pandemic.
In 2010, as part of the Canadian Society of Pharmacology and Therapeutics Annual meeting Pregmedic organized a symposium on Drugs used during Pregnancy and Breastfeeding.
Health Canada's project of modernizing their Food and Drug Regulations was presented and will no doubt, provide better information about drugs for use in pregnancy and lactation. Pregmedic supports this initiative.
Presently, the USA Food and Drug Administration (FDA) requires drug manufacturers to collect data in pregnancy registries even for drugs not labeled for use in pregnancy. In addition, FDA is proposing to amend its regulations concerning the format, content and labelling of the Pregnancy, Labour and Delivery, and also NursingMothers subsections of the ''Use in Specific Populations'' to provide better information to physicians.
Pregmedic would like to see this as part of Canada's regulatory framework. The collection and analysis of data on foetal safety should be a key part of any drug review standard and/or guidelines aimed at safeguarding the health of pregnant women and their offspring.
Pregmedic encourages that any product labelled for use during pregnancy undergo rigorous scientific and regulatory standards of safety and efficacy. An on-going post-marketing surveillance system should also be established in partnership with all concerned stakeholders.
Depression is an ongoing concern for pregnant women and their fetuses. Pregmedic encourages that more information be able to better treat pregnant women.
Natural health products are another group of products which need to be better understood in the treatment of pregnant women.
Pregmedic Priorities:
- Draft Guideline for Inclusion of Pregnant Women in Pharmacokinetics studies was presented to Health Canada in June 2009;
- Advocate for the adoption of the European Labelling Requirements for Pregnancy and Lactation (EMEA) by Health Canada;
- Request creation of registries for women who need to take drugs during pregnancy and require manufactures to have post market surveillance studies;
- Advocate for better regulation of natural health products labelled for use in pregnancy.
OPENING REMARKS AND MODERATOR
Dr. Donald B. Davis, FRCSC, Past President, Society of Obstetricians and Gynaecologists of Canada
MEDICATION EXPOSURE IN PREGNANCY RISK EVALUATION PROGRAM (MEPREP)
Dr. Robert Davis, Center for Health Research, Kaiser Permanente of Georgia, USA
PROPOSED COMPREHENSIVE MODERNIZATION OF THE REGULATORY FRAMEWORK
Dr. Maurica Maher, Office of Legislative and Regulatory Modernization, Health Canada, Ottawa
PREGNANCY & LACTATION: LABELLING EXAMPLES
Dr. Gideon Koren, Motherisk Program, Hospital for Sick Children, Toronto
H1N1 AND PREGNANCY – LESSONS LEARNED
Dr. Ken Scott, Pandemic Preparedness Division, Public Health Agency, Ottawa
DEPRESSION AND PREGNANCY
Dr. Alicja Fishell, Department of Psychiatry, Women's College Hospital, Toronto
HERBAL MEDICINE AND PREGNANCY
Dr. Jean-Jacques Dugoua, Naturopathic Medicine, Toronto Western Hospital, Toronto
CLOSING REMARKS
David C. Knoppert, Chair of Pregmedic and Department of Pharmacy, St Joseph's Hospital, London
