E-DRUG: Editing/checking package inserts (3)
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In Canada and the US the product monograph or the package insert is a
legal document. It can not be manipulated without serious legal
consequences for both the drug company and government authority. In
other word, it is not up to the drug company or the government authority
to include or omit information from the package insert without
accountability. Both parties work side by side to agree on the
disclosed / published package insert. Barring in mind that Ministry of
Health first and only duty is to protect the public, information
provided to the health care practitioner is presumably complete,
evidence based, and up-todate.
Product monographs / package inserts are prepared in Canada by the drug
companies and reviewed by Health Canada. No information is added or
eliminated without final approval and endorsement by the Therapeutic
Products Directorate (TPD), Health Canada.
Sana R. Sukkari
Oncology/Palliative Care Pharmacist
Burlington, On
Canada
ssukkari@jbmh.com
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