The reporting of suspected serious adverse drug reactions (ADRs) to government regulators of the pharmaceutical industry by consumers (parents, guardians or caregivers) is key to identifying drug safety issues and improving prescription drug safety.
Health Canada defines a serious ADR as a noxious and unintended response to a drug that occurs at any dose and that:
- Requires in-patient hospitalization or prolongation of existing hospitalization;
- Causes congenital malformation;
- Results in persistent or significant disability or incapacity;
- Is life-threatening; or
- Results in death.
Here are the ADR reporting websites for a few countries:
- Australia – Department of Health: Therapeutic Goods Association
- Canada – Health Canada
- New Zealand – Pharmacovigilance Centre
- United Kingdom – Yellow Card: MHRA
- United States – MedWatch: FDA