Drug Safety

What is pharmacovigilance?

According to the World Health Organization (WHO), “pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”

The tragedy of thalidomide has created a huge awareness of the importance of pharmacovigilance for prevention. We believe that organizations working in the field of pharmacovigilance play a crucial role in protecting unborn children.

In Canada

  • Medications & Pregnancy – Team of researchers working in the laboratory of Dr. Anick Bérard at the Centre Hospitalier Universitaire (CHU) Sainte-Justine Research Center, affiliated with the University of Montreal, whose mission is to determine the risks and benefits associated with the use of drugs during pregnancy and lactation, to inform evidence-based decision-making by health professionals and pregnant women.
  • Motherisk -The Motherisk Program at the Hospital for Sick Children provides up-to-date information about the risk and safety of medications and other exposures during pregnancy and breastfeeding. Research and education in the program is also an important ongoing activity. Motherisk counselors are ready to answer calls and provide information to women, their partners and health-care providers.

More resources on pharmacovigilance

  • Centre de référence sur les agents tératogènes (CRAT) – Information service at the Armand-Trousseau Hospital in Paris on the risks of drugs, vaccines, radiation and addictions during pregnancy and breastfeeding. The CRAT website is written for health professionals. (in French only)
  • Drugwatch – Online database featuring extensive information about thousands of different medications and drugs currently on the market or previously available worldwide.
  • Infantrisk Center -Texas Tech University Research Center on drug safety during pregnancy and breastfeeding.
  • International Society of Pharmacovigilance (ISoP): International non-profit scientific organisation, which aims to foster pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of medicines, in all countries.  Drug Safety, the official journal of ISoP, is a peer-reviewd journal published on a monthly basis.
  • LactMed® – The LactMed® database contains information on drugs and other chemicals to which breastfeeding mothers may be exposed. It includes information on the levels of such substances in breast milk and infant blood, and the possible adverse effects in the nursing infant. Suggested therapeutic alternatives to those drugs are provided, where appropriate. All data are derived from the scientific literature and fully referenced. A peer review panel reviews the data to assure scientific validity and currency.
  • March of Dimes – Information about substances to avoid during pregnancy.
  • MotherToBaby – MotherToBaby, a service of the non-profit Organization of Teratology Information Specialists, is dedicated to providing evidence-based information to mothers, health care professionals, and the general public about medications and other exposures during pregnancy and while breastfeeding. MotherToBaby affiliates support and contribute to worldwide initiatives for teratology education and research.
  • Teratology Society – The Teratology Society is a multidisciplinary scientific society founded in 1960, the members of which study the causes and biological processes leading to abnormal development and birth defects at the fundamental and clinical level, and appropriate measures for prevention.
  • UK Teratology Information Service (UKTIS) – The UK Teratology Information Service (UKTIS) is commissioned by Public Health England on behalf of UK Health Departments.  We provide a national service on all aspects of the toxicity of drugs and chemicals in pregnancy.
  • World Health Organization (WHO) Program for International Drug Monitoring – Program established by the WHO following the thalidomide tragedy.  The program promotes pharmacovigilance at a country level. To this day, there are 123 States members to the program, who submit reports of adverse reactions associated with medicinal products, known as Individual Case Safety Reports (ICSRs) to the WHO global database, VigiBase®.
  • VigiAccess : Public access to the data contained in WHO Program for International Drug Monitoring database.