Final 2 - NHP's & OTC Drugs Flashcards
What is the definition of a drug under Canadian law?
A product intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease.
What must food products be in Canada?
Safe, pure (unadulterated), and not required to show effectiveness.
What must drugs show in Canada?
They must be shown to be safe when used as directed and effective for their intended use.
What does NHP stand for?
Natural Health Product.
What is the purpose of NHPs?
Diagnosing, treating, mitigating, or preventing disease, restoring or modifying organic functions.
What does NNHPD stand for?
Natural and Non-prescription Health Products Directorate.
When was NNHPD originally established?
2004 as NHPD, renamed in 2015.
What must NHPs have to be legally sold in Canada?
A product license and site licenses for manufacturing sites.
What number do licensed NHPs bear on their label?
An eight-digit product license number preceded by NPN or DIN-HM.
What must all NHPs be as safe as?
Over-the-counter (OTC) products.
What are sources of evidence for NHP safety and effectiveness?
Clinical trial data, published studies, traditional resources.
How many Canadians use NHPs regularly?
0.61
Which NHP is used by 70% of Canadians?
Vitamins.
What is St. John’s Wort used for?
To relieve restlessness, nervousness, and help treat symptoms of sleep disorders.
What is SAMe?
A naturally occurring substance in the body licensed to support healthy mood balance.
What is Gingko Biloba thought to improve?
Memory and cognitive function.
What effect does Gingko Biloba have on blood?
Reduces blood clotting.
What is Melatonin used for?
Increasing total sleep time in people with sleep restriction or altered sleep schedules.
What are OTC drugs?
Medicines sold directly to consumers without a prescription.
How is the safety of OTC drugs determined?
By evaluating their active pharmaceutical ingredients.
How many OTC drugs exist?
More than 100,000.
What are behind-the-counter drugs?
Non-prescription drugs dispensed with pharmacist advice due to possible adverse effects.
What are examples of behind-the-counter drugs?
EpiPens, polysporin eye drops, lice shampoo.
What system classifies drug schedules in Canada?
NAPRA (National Association of Pharmacy Regulatory Authorities).