Generic and Counterfeit Drugs Flashcards
What must a manufacturer submit for authorization to conduct a clinical trial in Canada?
Clinical Trial Application (CTA)
What is an NDS?
New Drug Submission
-must be submitted to Health Canada to establish that a drug
is safe, effective, and of high quality
What is a generic drug? List some characteristics of generic drugs.
generic drugs are a copy of a brand name product
same medicinal ingredients as the brand name
bioequivalent to the reference product
True or false: there is only one generic version of the reference product
false
What percentage of prescriptions are generic drugs in Canada?
70%
What percentage of money spent on prescriptions are generic drugs in Canada?
20%
What percentage of prescriptions are generic drugs in the USA?
90.4%
Name off differences between reference drugs and generic drugs that account for the price differences.
reference drugs
-expensive
-5/5000 new drug candidates tested in humans & 1 approved
-takes 12-15yrs
-costs around 1 billion $
-drug patents of 20yrs, applied before clinical trials begin
-effectively 7-12yrs
generic drugs
-30-80% cheaper
-fraction of the cost of testing & development
-approved for sale after drug patent protection expires
What might be different between brand name and generic drugs?
excipients
-although the manufacturer must show that the different non-
medicinal ingredients did not change the quality, safety or
effectiveness of the drug
What is bioavailability?
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 variables used to assess bioavailability?
blood concentration over time
maximum concentration of the active ingredient in the blood stream
What is 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
List off the many ways that generic companies compete with the larger pharmaceutical companies.
they dont have to invest millions in R & D
they dont have to spend 10 years in the R & D process
they dont have to do initial marketing (commercialization cost)
synthesis and formulation difficulties are resolved
True or false: generic companies do perform research
true
although the burden to reach the commercial product is less
What must be submitted by a company that wants to manufacture their own version of a previously approved drug?
Abbreviated New Drug Application (ANDA)
What scientific evidence must be shown in an ANDA?
safety and efficacy
bioequivalence to the original product
details on production, packaging, and labelling must meet cGMP standards
When can you not substitute a generic drug for a brand name drug?
if it is a drug with a narrow therapeutic index
How many NTI drugs have been indicated by the FDA?
25
What are examples of NTI drugs?
carbamazepine
digoxin
levothyroxine
phenytoin
theophylline
cyclosporine
warfarin
fentanyl
immunosuppressants
What is a counterfeit drug?
medication which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness
What is the normal bioequivalence limits? What about for NTI drugs?
80-125%
90-111%
What might be some situations where a drug is considered to be counterfeit?
it does not contain active ingredients
it contains an insufficient quantity of active ingredients
it contains the incorrect active ingredients
inaccurate packaging
What are the general characteristics to classify counterfeit drugs?
re-labeled drugs that:
-were expired or defective
-have an active ingredient fraudulently diluted
-active ingredient is adulterated
-active ingredient is substituted
-active ingredient is misrepresented
Where are counterfeit drugs a large problem?
countries where regulatory oversight and law enforcement are weak (Africa, Asia, Latin America)
-less than 1% in most industrialized countries
Which products tend to be worse for counterfeit?
supplements
health products
What are some tips for buying drugs safely online?
dont buy if a prescription isnt required
dont deal with sites that provide Rx based on questionnaires
dont buy from sites that advertise “miracle drugs”
make sure there is a licensed pharmacist
beware if no address or phone number is listed
avoid sites that sell “lifestyle” medications
make sure the seller is licensed
check where the seller is located
ensure the NAPRA or CIPA seal is legit
How can you ensure the CIPA seal is legit?
click on the seal and ensure it takes you to CIPA.com as some fake sellers copy the seal
What are signs that a drug is counterfeit?
labelling with spelling mistakes
poor printing quality on package
no DIN or NPN
different taste from normal product
What are some ways to test for fake drugs?
wet chemical procedures (TLC)
chemical surface mapping (FT-IR, spectroscopy)
chemical tags
Why are counterfeit drugs a concern to Canadians?
patients travel to other countries and inadvertently obtain counterfeit drugs
Canadians may purchase counterfeit drugs online from foreign pharmacies
natural products and supplements are a huge source of counterfeit drugs
