INDEPTH: FAINT WARNING
Should you file an adverse drug reaction
CBC News Online | February 17, 2004
Here are some guidelines to consider from Health Canada before
reporting an adverse drug reaction to the Canadian Adverse Drug
Reaction Monitoring Programme (CADRMP).
CADRMP is largely a voluntary system and is dependant on
the cooperation of health-care professionals, patients, and
consumers to accurately report adverse drug reactions that
meet the criteria set out below. Pharmaceutical companies
are required by law to report.
What is an adverse drug reaction?
An adverse drug reaction is any unintended response to a
drug, which includes prescription, non-prescription, biological,
and herbal drug products. Drug abuse, drug interactions, and
overdoses are also monitored using the reporting system.
A possible link between a drug and an adverse reaction is
sufficient to file a report.
ADR reports do not imply a causal link between a reaction
and a suspected drug.
When should adverse drug reactions be reported?
Adverse drug reactions (ADRs) should be reported when:
1) The reaction to a drug is unexpected, no matter how severe.
This means there is no indication on the labelling or drug
information that such a reaction might occur.
2) The reaction is serious. Health Canada defines a serious
reaction in the following way:
"A noxious and unintended response to a drug, which
occurs at any dose and 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. Important
medical events that may not be immediately life-threatening
or result in death or hospitalization, but may jeopardize
the patient or may require intervention to prevent one of
the outcomes listed above, may also be considered serious."
3) The reaction, regardless of its severity or type, is caused
by a drug that has come on the market within the last five
Who can report an adverse drug reaction?
Reports can be filed by patients, consumers, doctors, pharmacists,
and other health professionals. It is mandatory for pharmaceutical
companies to report.
How do I report an ADR?
If you want to file an Adverse Drug Reaction report, go the
Canada adverse reaction reporting page
and follow their instructions. Health Canada set up a toll-free
number in January 2003.
Source: Health Canada
on adverse drug reaction reporting,
from Health Canada
Fact sheets on the Canadian Adverse Drug Reaction Monitoring Program
to Health Canada's e-mail list, MedEffect e-Notice, to receive
all warnings sent out by the department
to the U.S. Food and Drug Administration's e-mail list for