NHP Approval Process Flashcards
Each NHP must have a ________ _______, while each producer of the NHP must have a ____ ________.
product license; site license
What is needed for a site license?
In addition to meeting GMP standards, they must also demonstrate adequate record keeping of product distribution, procedures for dealing with product recalls, and they must document the ability to appropriately store, handle, and deliver the product for which the site license is requested.
Health Claims are based on risk factors. What are low risk? (3)
- Support health
- Normal physiological role
- Minor, self-limiting condition
Health Claims are based on risk factors. What are medium risk? (5)
- Treat
- Prevent
- Specific disease
- Less serioius disease
- Disclaimers (co-therapy, special populations)
Health Claims are based on risk factors. What are high risk? (5)
- Cure
- Treat
- Disease is serious
- Delay in treatment would be serious
- Potential for serious adverse effects
Risks related to safety and efficacy includes potential risks due to: (3)
- An ingredient’s physical or chemical form
- The seriousness of the health claim and the conditions of use implied
- The health impact from lower than expected performance of the product
At any level of risk, additional evidence may be necessary to substantiate safety and efficacy for: (4)
- Vulnerable sub-populations (e.g., children, pregnant and breastfeeding women, elderly)
- Any known interaction among ingredients
- Any known interaction with any other product/medication
- Any indication that the product/ingredients may alter diagnostic testing
What are some factors that constitute ‘risk’?
- Patient issues
- Product quality issues
- Adverse Events
What are patient issues when thinking risk? (4)
- No supervision (e.g. patient with HTN)
- Stage of life (metabolism, meds, risk of ADRs)
- Hydration, exertion
- Drug interactions
What are product quality issues when thinking risk? (5)
- Contaminants-heavy metals from product source
- Adulteration – substitution with cheaper/other ingredient/ pharmaceutical/ wrong plant species
- Errors in concentration
- Inappropriate labeling
- Change in traditional medicine method of prep vs modern extraction methods – toxicity possible
What are adverse events when thinking risk? (6)
- Adulteration, contamination, metabolism
- Drug interactions
- Lack of data from clinical trials due to poor power or design, poor specificity
- Inappropriate use, high dose
- Idiosyncratic reactions
- Reports are a source of safety information, few available, few publications in the medical lit.
Which of the following is NOT a natural health product (NHP)?
a. Sennakot
b. Cranberry extract
c. Ferrous gluconate
d. Melatonin
a.
If a herbal medicine product has an NPN this means: it is
a. excluded from regulations but catalogued by Health Canada
b. an exempt homeopathic preparation
c. in the process of regulatory approval by Health Canada
d. approved as a natural health product by Health Canada
d.
Which of the following is a natural health product?
a. topical diclofenac
b. valprioic acid
c. acetaminophen
d. amino acid supplement
d.
Which ONE of the following meets the minimum evidence requirements for a NHP whose health claims fall into the “low risk” category for efficacy for a compound other than a vitamin supplement?
a. Review article in a medical journal
b. Two phase II clinical trials
c. One pilot study
d. Demonstration of food use
b.
Reasons why patients may use BOTH alternative medicine (CAM, herbals) AND western medicine (drugs, typical medical practice that we study) include:
a. prefer a holistic approach to health
b. following what family members suggest
c. cultural traditions
d. all of the choices are possible reasons
d.
Which ONE of the following is correct about nutritionists?
a. They all follow evidence-based practice
b. Registered dieticians are nutritionists
c. All nutritionists must have a university degree in nutrition with at least a year of internship
d. Nutritionists belong to a federally regulated profession
b.
Which of the following is NOT within the scope of practice for a naturopathic doctor?
a. acupuncture
b. providing herbal remedies
c. vitamin therapy
d. prescribing drugs
d.
Product Y23 makes the health claim that it “cures urinary tract infections.” What evidence would meet the minimum requirements of evidence for this health claim?
a. Meta-analysis of Phase III clinical trials with primary evidence
b. Ten-year span of epidemiological studies
c. Demonstration of food use
d. One prospective study and one retrospective study
a.
At a company producing an NHP, a technician cleans manufacturing equipment between batches according to a standard operating procedure (SOP). This is an example of which one of the following categories of activity:
a. change management
b. quality control
c. quality assurance
d. quality management
b.
A technician at a company producing an NHP finds that regulators have required that a new standard must be used in the measurement of a compound that is found in the NHP. She develops a revised SOP reflecting the new procedure and updates staff on the revision that is required to meet the new specification. She documents the revision in the SOP with the date and reason for the update. These activities are part of:
a. change control
b. quality assurance
c. quality control
d. quality assurance and change control
d.
The reporting of adverse reacations after an NHP has already been marketed is called ________________
pharmacovigilance
Which one of the following is NOT required to be on the product label of an NHP?
a. Safe dosage instructions
b. Storage instructions
c. List of excipients
d. Proportion of minor components in a product that is a mixture
d.
An NHP based on a traditional herbal medicine is under review for approval. The manufacturer has proposed an extraction method from the plant material that is solvent-based to increase potency rather than a traditional tea using hot water. Since the herbal medicine has been used for many years and its safety as a traditional medicine is well-established, would there be any further need of safety evidence, and if so, why?
a. No, because the active ingredient is the same
b. Yes, because traditional medicines have no safety evidence
c. Yes, because the higher potency product may cause additional adverse effects
d. No, because there is already a long history of safe use
c.
At a company producing an NHP, a technician reviews batch records to check if the temperature of a process was recorded during each run according to the standard operating procedure (SOP) of the relevant step. This is an example of:
a. quality control
b. quality management
c. quality assurance
d. change management
c.
Which of the following is an appropriate claim for flaxseed oil product containing omega-3 fatty acids?
a. Cures Alzheimer disease
b. Prevents aging
c. Source of essential fatty acids to prevent heart attacks
d. For the maintenance of good health
d.
