Objective Is To Increase Percentage Of ADRs That Get Reported To Regulators
In October 2006 Health Canada announced that its MedEffect web site is now able to accept online reports of suspected adverse drug reactions (ADRs) for those prescription medications marketed in Canada. This announcement was published in the Canadian Adverse Reaction Newsletter, Volume 16, Issue 4, released in October 2006.
Before this electronic upgrade and practical improvement, doctors or patients who wanted to report serious side effects due to use of a prescription drug had to call in, fax, or mail a paper ADR report form to Health Canada.
According to Health Canada, the new MedEffect online reporting system generates a file that can be printed and stored electronically by the person submitting an ADR report online. As with the earlier methods of reporting ADRs to Health Canada, any and all information regarding the identity of a subject patient as well as the person making the ADR report to the MedEffect program will be kept strictly confidential.
According to Health Canada's October 2006 Canadian Adverse Reaction Newsletter:
Underreporting of [adverse drug reactions] is a well-known global issue. International studies have estimated that only 1%-10% of all [ADRs] are reported. Health professionals have identified barriers to reporting that relate to the inconvenience and lack of user-friendliness of reporting.
A link to Health Canada's MedEffect web site can be found in the sidebar, under the heading Resources.
(Posted by: Tom Lamb)