Generic Drugs Flashcards
Define Generic Drugs
a copy of a brand name product
How does a drug approval processes happen?
a manufacturer must submit a clinical trial application for authorization to conduct a clinical trial in Canada
Then NDS to health canada to establish that a drug is safe, effective and of high quality
Bioavailability
a measure of the rate and extent to which the therapeutically active ingredient in a drug product is absorbed into the body
What are the two main variables
- blood concentration over time
- the maximum concentration of the active ingredient in the blood stream
Bioequivalence
the property wherein two drugs with identical active ingredients or two different dosage forms of the same drug possess similar bioavailability and produce the same effect at the site of physiological activity
What does a ANDA have to show?
Abb. new drug application
have to show safety and efficacy
bioequivalence
details on the productions
When is it not ok to substitute?
when the drugs have a very narrow therapeutic index
What is a counterfeit drug?
a medication which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness
What are some traits of counterfeit drug?
does not contain active ingredients
contains an insufficient quantity of active ingredients
which is typically sold with inaccurate, incorrect or fake packaging
Counterfeit drugs can be classified by the following characteristics?
re-labeled drugs that were previously expired, defective
re-labeled drugs where in the active ingredient is fraudulently
adulterated
falsely labeled
Why are counterfeit drugs a “global calamity”?
manufacture, distribution and marketing of counterfeit drugs have become a lucrative and growing business worldwide
Why are counterfeit drugs a concern to Canadians?
they have been found in Canada
when we travel to other countries
can buy counterfeit drugs online
Tips for Buying Drugs Safely Online
don’t buy from online seller that doesn’t require a prescription
if you don’t already have prescription dont use online questionnaire without an in person physical exam
What is needed to show that it is a legitimate online pharmacy?
Canadian International Pharmacy Association dynamic seal
Counterfeit products may have one or more of the following characteristics?
labels with spelling mistakes
packaging with poor printing quality
labels with no DIN or NPN
product having different taste or flavour than the product normally used
