NHP Intro Flashcards
What are natural health products?
In Canada, NHPs can be in capsule, tablet, or liquid form. They supplement the diet and are not considered a substitute for food. Hence the term “dietary supplement”
True or False? NHPs can basically be purchased anywhere
True - no Rx needed - health food stores, supplement shops, grocery and department stores, etc.
What are some of the risks of unregulated, unapproved NHPs? (6)
- Contamination: hazardous substances, incorrect ingredients or dosage wrong due to concentration errors
- False or unproven claims: can lead people to use the products for serious conditions or delay medical treatment
- Incorrect instructions
- Lack of warnings that a product may not be suitable for certain populations
- Lack of information regarding potential interactions with Rx drugs, or with other NHPs
- Unwanted side effects, DIs, or allergic reactions
Who regulates NHPs in Canada?
The Natural and Non-Prescription Health Products Directorate (NNHPD)
List what is defined as an NHP (6)
- Probiotics
- Herbal remedies
- Vitamins and minerals
- Homeopathic medicines
- Traditional medicines such as traditional Chinese medicines
- Other products like amino acids and essential fatty acids.
Approved NHPs are subject to specific labelling requirements and bear an ___
NPN
Products with an NHP license have been assessed by Health Canada and found to be ____, _________, and of ____ _______ under their recommended conditions of use
safe, effective, high quality
What are the labelling requirements for an NHP? (7)
- Product name
- Product license number
- Quantity of product in the bottle
- Complete list of medicinal and non-medicinal ingredients
- Recommended use (including purpose or health claim, route of admin and dose)
- Any cautionary statements, warnings, contra-indications and possible adverse reactions associated with the product
- Any special storage conditions
What are the evidence requirements for safety and efficacy of NHPs? (5)
NHP clinical trials:
1. A clinical trial is when NHPs are tested using human subjects. Clinical trials are intended to:
2. Discover or verify the product’s effects
3. Identify any adverse events that are related to its use
4. To study its absorption, distribution, metabolism and excretion
5. To test its safety or efficacy
What are some factors contributing to increased use of NHPs? (8)
- Various claims on the efficacy or effectiveness of plant medicines
- Preference of consumers for natural therapies and a greater interest in alternative medicines
- Erroneous belief that herbal products are superior to manufactured products
- Dissatisfaction with the results from orthodox pharmaceuticals and the belief that herbal medicines might be effective in the treatment of certain diseases where conventional therapies and medicines have proven to be ineffective or inadequate
- High cost and side effects of most modern drugs
- Improvements in the quality, efficacy, and safety of herbal medicines with the development of science and technology
- Patients’ beliefs that their physicians have not properly identified the problem; hence the feeling that herbal remedies are another option
- A movement toward self-medication
The increasing utilization of herbs for self-medication by patients or individuals is also attributed to a number of other reasons such as: (3)
- Patients being uncomfortable about discussing their medical problems and fear lack of confidentiality in handling their health information
- Fear of possible misdiagnosis and wrong treatment by patients with non-specific symptoms or general malaise; and
- Lack of time to see a physician; this is usually a reason where prior visit did not yield any positive experience
What are the 4 big pillars of ethics in pharmacy?
- Autonomy
- Justice
- Beneficence
- Non-maleficence
What is autonomy (ethics)?
- What are the patient’s wishes and values?
- Self-determination.
- Participate in own health care decisions
What is justice (ethics)?
- Is the pt being treated fairly, and are his/her needs able to be satisfied?
- Respect for rights
- No discrimination
What is beneficence? (2)
- What is in the patient’s best interest?
- Maximizing patient benefit
What is non-maleficence (ethics)?
- What can be done for the patient?
- Do no harm; balance risk vs. benefit
