Intro to NHPs Flashcards
What kind of dosage forms do natural health products come as?
tablets
capsules
liquid
Are natural health products a substitute for food?
they supplement the diet are not considered a substitute for food
-hence the term “dietary supplement”
What are the risks with using natural health products?
contamination
-hazardous substances, incorrect ingredients or dosage
false or unproven claims
incorrect instructions
lack of warnings that a product may be inappropriate for certain populations
lack of info regarding drug interactions
unwanted side effects or allergic reactions
What is the risk associated with false or unproven claims of natural health products?
can lead people to use the products for serious conditions or delay medical treatment
When might NHPs have a legitimate role?
when the evidence and safety studies are supporting of very specific claims
Who regulates NHPs in Canada?
the Natural and Non-Prescription Health Products Directorate (NNHPD)
-NHPs must be reviewed and approved by NNHPD before they can be sold in Canada
What are NHPs?
probiotics
herbal remedies
vitamins and minerals
homeopathic remedies
traditional medicines
others (ex: amino acids, essential fatty acids)
What are approved NHPs subject to?
specific labeling requirements and bear an NPN
What are the labeling requirements for a NHP?
product name
product license number
quantity of product in the bottle
complete list of medicinal and non-medicinal ingredients
recommended use (purpose/health claim, route, dose)
cautionary statements (warnings, CI, AEs)
special storage conditions
What does the type and amount of evidence required to support NHPs depend on?
the proposed health claim of the product and its overall risks
Who evaluates efficacy of NHPs?
NNHPD
What is the intent of clinical trials?
to discover or verify the products effects
to identify any adverse events related to use
to study its ADME
to test its safety or efficacy
The bigger the ___, the stronger the ___ that is required.
the bigger the claim, the stronger the evidence that is required
Differentiate high, medium, and low risk claims.
high:
-potential for harm, serious condition, harm if untreated
-need clinical trial
medium:
-no clinical trial, maybe systematic review/journals/phase 1/2
low:
-low toxicity
-textbooks
What are some factors contributing to increased use of NHPs?
claims on efficacy of plant medicines
preference for natural therapy/interest in alt medicine
belief that herbal products > manufactured products
unsatisfied with orthodox pharmaceuticals
high cost and side effects of modern drugs
improvements in quality, efficacy, and safety of herbals with science and technology
belief that physician did not identify the problem
movement towards self-med
uncomfortable discussing medical issues or fear lack of privacy
fear of misdiagnosis and wrong treatment
lack of time to see physician or poor prior experience
