Generic and Counterfeit Drugs Flashcards
What do drug manufacturers have to submit for authorization to conduct a clinical trial in Canada?
Clinical Trial Application (CTA)
What do drug manufacturers have to submit inorder to establish a drug is safe, effective, and of high quality?
New Drug Submission (NDS)
What is a generic drug?
Generic drugs contain the same medicinal/active ingredients as the brand name drug, and are considered bioequivalent to the reference product.
Excipients/inactive ingredients can be different from the brand name product
What is the contribution of generic prescriptions to usage and costs in Canada?
Generic prescriptions in Canada represent less than 70% of prescriptions but about 20% of money spent on prescriptions.
Therefore, brand name prescriptions account for 80% of prescription costs
How are generic prescriptions approved for sale in Canada?
The generic manufacturer must provide studies to Health Canada showing that the different non-medicinal ingredients have not changed the quality, safety, or effectiveness of the generic drug
To prove that their product are safe and effective, generic drug manufacturers must demonstrate to Health Canada that the generic drug performs similarly to the brand name drug (comparative bioavailability testing or clinical efficacy)
What the difference between bioavailability and biopequivalency?
Bioavailability is a measure of the rate and extent to which the therapeutically active ingredients in a drug product is absorbed into the body. Bioavailability is represented by the area under the curve of a plasma concentration vs. time graph (AUC)
Bioequivalence is 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. The bioavailability curves of bioequivalent drugs are similar
How do generic drugs compete with brand name drugs?
Generic drug manufacturers have lower costs in terms of development and marketing costs. Generic drug manufacturers have to submit an Abbreviated New Drug Application (ANDA) to Health Canada before their generic product can hit the market.
This submission must show rigorous scientific evidence regarding:
Safety and efficacy
Bioequivalence
Production details
When is substituting a brand name drug for a generic inappropriate?
In drugs with narrow therapeutic indexes, slight differences in bioavailability between brand name and generic drugs can put the patient into either sub-therapeutic or toxic ranges of a given drug
ex. carbamazepine, warfarin, immunosuppressants
What are the bioequivalence limits?
In drugs with wide therapeutic indexes, bioavailabilities within 80%-125% are acceptable
In drugs with narrow therapeutic indexes, bioavailabilities within 90%-111% are acceptable
What are counterfeit drugs?
Counterfeit drugs are medications that are produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness
A counterfeit drug may be one which:
It does not contain active ingredients
Contains an insufficient quantity of active ingredients
Contains entirely incorrect active ingredients (which may or may not be harmful)
The safest counterfeit drugs are those that have no active ingredients at all (sugar pills)
How are counterfeit drugs a global calamity?
In most industrialized countries with strict regulation and enforcement, counterfeit drugs amount to less than 1% of the pharmaceutical market. But in counties with lax regulation and enforcement, counterfeit drugs are believed to represent 10%-30% of the total drug market.
How can consumers protect themselves from purchasing counterfeit drugs online?
Avoid “miracle drugs”
Ensure a licensed pharmacist is available to answer your question
Lack of contact information (hard to track down)
Avoid websites that only sell a limited number of medications (obesity, impotence, herpes, pain, and acne)
If buying drugs online, ensure a reputable pharmacy association properly licenses the seller
If you have been sold counterfeit drugs, report it to the Health Protection Board at Health Canada
How to tell if a drug product is counterfeit?
Counterfeit products may have one or more of the following characteristics:
Labels with spelling mistakes
Packaging with poor printing quality (not raised print, “cheap” looking)
Labels with no Drug Identification Number (DIN) or Natural Product Number (NPN)
Product having different taste, flavour, texture, shape, etc. than the product normally used
How to test drugs for whether they are counterfeit or not?
Determining whether a suspect product is genuine or counterfeit is often done with wet-chemical procedures, such as thin-layer chromatography.
FT-IR and special spectroscopy techniques are newer approaches that are non-destructive
The WHO and FDA are investigating the use of chemical tags and anti-tampering packaging to improve detection of counterfeit drugs
