Generic and Counterfeit Drugs

Question 1

What must a manufacturer submit for authorization to conduct a clinical trial in Canada?

Answer 1

Clinical Trial Application (CTA)

Question 2

What is an NDS?

Answer 2

New Drug Submission
-must be submitted to Health Canada to establish that a drug
is safe, effective, and of high quality

Question 3

What is a generic drug? List some characteristics of generic drugs.

Answer 3

generic drugs are a copy of a brand name product
same medicinal ingredients as the brand name
bioequivalent to the reference product

Question 4

True or false: there is only one generic version of the reference product

Answer 4

false

Question 5

What percentage of prescriptions are generic drugs in Canada?

Answer 5

70%

Question 6

What percentage of money spent on prescriptions are generic drugs in Canada?

Answer 6

20%

Question 7

What percentage of prescriptions are generic drugs in the USA?

Answer 7

90.4%

Question 8

Name off differences between reference drugs and generic drugs that account for the price differences.

Answer 8

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

Question 9

What might be different between brand name and generic drugs?

Answer 9

excipients
-although the manufacturer must show that the different non-
medicinal ingredients did not change the quality, safety or
effectiveness of the drug

Question 10

What is bioavailability?

Answer 10

measure of the rate and extent to which the therapeutically active ingredient in a drug product is absorbed into the body

Question 11

What are the two variables used to assess bioavailability?

Answer 11

blood concentration over time
maximum concentration of the active ingredient in the blood stream

Question 12

What is bioequivalence?

Answer 12

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

Question 13

List off the many ways that generic companies compete with the larger pharmaceutical companies.

Answer 13

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

Question 14

True or false: generic companies do perform research

Answer 14

true
although the burden to reach the commercial product is less

Question 15

What must be submitted by a company that wants to manufacture their own version of a previously approved drug?

Answer 15

Abbreviated New Drug Application (ANDA)

Question 16

What scientific evidence must be shown in an ANDA?

Answer 16

safety and efficacy
bioequivalence to the original product
details on production, packaging, and labelling must meet cGMP standards

Question 17

When can you not substitute a generic drug for a brand name drug?

Answer 17

if it is a drug with a narrow therapeutic index

Question 18

How many NTI drugs have been indicated by the FDA?

Answer 18

25

Question 19

What are examples of NTI drugs?

Answer 19

carbamazepine
digoxin
levothyroxine
phenytoin
theophylline
cyclosporine
warfarin
fentanyl
immunosuppressants

Question 20

What is a counterfeit drug?

Answer 20

medication which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness

Question 21

What is the normal bioequivalence limits? What about for NTI drugs?

Answer 21

80-125%
90-111%

Question 22

What might be some situations where a drug is considered to be counterfeit?

Answer 22

it does not contain active ingredients
it contains an insufficient quantity of active ingredients
it contains the incorrect active ingredients
inaccurate packaging

Question 23

What are the general characteristics to classify counterfeit drugs?

Answer 23

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

Question 24

Where are counterfeit drugs a large problem?

Answer 24

countries where regulatory oversight and law enforcement are weak (Africa, Asia, Latin America)
-less than 1% in most industrialized countries

Question 25

Which products tend to be worse for counterfeit?

Answer 25

supplements
health products

Question 26

What are some tips for buying drugs safely online?

Answer 26

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

Question 27

How can you ensure the CIPA seal is legit?

Answer 27

click on the seal and ensure it takes you to CIPA.com as some fake sellers copy the seal

Question 28

What are signs that a drug is counterfeit?

Answer 28

labelling with spelling mistakes
poor printing quality on package
no DIN or NPN
different taste from normal product

Question 29

What are some ways to test for fake drugs?

Answer 29

wet chemical procedures (TLC)
chemical surface mapping (FT-IR, spectroscopy)
chemical tags

Question 30

Why are counterfeit drugs a concern to Canadians?

Answer 30

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