Quality Evaluation of Pharmaceuticals Flashcards
What act regulates dietary supplements?
Dietary Supplement Health and Education Act of 1994 (DSHEA)
dietary supplement?
a product (other than tobacco) intended to supplement the diet
What can a dietary supplement contain? (6)
- vitamin
- mineral
- herb
- amino acid
- may supplement the diet by increasing the total diet intake
- a concentrate, metabolite, constituent, extract, or combo
T/F There is NO FDA approval required to the selling of DS
TRUE
T/F The company does not have to provide info that the new product “will reasonably expected to be safe”
FALSE: DOES
Who determines the safety of their product?
the company seeking to market their product
When does the FDA get involved with DS?
When there is a problem with the DS
A manufacturer must repot adverse reactions from their product within 15 days….
Dietary Supplement and Nonprescription Drug Consumer Act (2006)
The label for a DS need to be _____ and ________
truthful and not misleading
T/F Manufacturers DO have to prove effectiveness.
FALSE : DO NOT, this is not a requirement for marketing
What are the 3 types of claims that are allowed by a DS?
- health
- nutrient
- structure/function
DS may not claim to ……. a specific disease or class of disease(5)
- diagnose
- mitigate
- treat
- cure
- prevent
CLAIM?
A link between a food substance/dietary supplement and dose or a health related condition
Health Claim
T/F Health Claims must be authorized by FDA before they may be used on label
TRUE
CLAIM?
Characterize the level of a nutrient or describe % level of dietary ingredient for which there is NO established Daily Value
Nutrient
CLAIM?
The role of a nutrient or dietary ingredient intended to affect normal structure or function in humans
-Could be statements about classical nutrient defiance disease
Structure/Function Claim
What claim do most DS fall under?
structure/function
TYPE of Claim?
♣ Soluble fiber, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease
Health
TYPE of Claim?
♣ Calcium builds strong bones
Structure/Function
TYPE of Claim?
♣ Promotes healthy cholesterol level
Structure/Function
TYPE of Claim?
♣ Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect
Health
TYPE of Claim?
♣ Calcium may reduce the risk of osteoporosis
Health
TYPE of Claim?
♣ Helps prevent mild memory loss associated with aging
Structure/Function
TYPE of Claim?
Chamomille product label states possible benefits include alleviation of insomnia, diverticular disorder, gum disease, and gingivitis
NOT ALLOWED
TYPE of Claim?
Protect against heart disease
NOT ALLOWED
TYPE of Claim?
Ginseng product label states it possesses a “Powerful Anti-cancer Function” and can prevent diabetes
NOT ALLOWED
When were regulations issued for GMP dietary supplements?
June 2007
What are the selected problems with dietary supplements? (2)
- Adulteration
- Contamination
addition of impure/inferior substance not normally present
adulteration
presence of a foreign material that makes the product impure
contamination
Which selected problem is this?
-¬Removal of a critical substance
adulteration
Which selected problem is this?
¬collection of crude drug substrate
¬debris, pests, stones, sticks, and undesirable plant material
¬current regulations may not be adequate to ensure quality of imported ingredients
contamination
What are some companies who assess quality of DS? (5)
- Natural Products Association Tru Label Program
- Good Housekeeping Institute
- Consumer Lab
- USP
- NSF (National Sanitary Foundation International)
Natural Product Association TruLabel Program (3)
- member companies pay for random laboratory tests
- companies whose products fail are expelled
- an internal oversight program for companies
Good Housekeeping Institute
products that have “sufficient quality” are qualified to advertise in the magazine and to carry good housekeeping seal
Consumer Lab (5)
- for profit program
- verfies content of a DS
- check for contaminants
- determines the initial aspect of bioavailability
- no GMP auditing
Which assessment quality programs:
- include GMP audits of manufacturers facilities
- started after members of the DS industry approached the organizations
USP and NSF (national sanitary foundation international)
T/F USP is a voluntary program.
TRUE
T/F NSF is a part of the Dietary Supplement Verification Program. (DSVP)
FALSE: USP
NSF vs. USP
¬ verifies products for content and label accuracy, monitors for purity and contaminants, audits the manufacturing process, conducts continued surveillance to ensure compliance
¬ demonstrate manufacturer conformance to currently recommended industry GMPs for dietary supplements.
NSF
NSF vs. USP
o specifically indicates that the product has been manufactured in compliance with GMPs
o contains the stated ingredients, in amount and strength, and that the product is pure and meets limits for contaminants
o will break down and release into the body within a specified amount of time
o random tests on products in marketplace
USP
T/F Dietary supplements are unregulated.
FALSE: ARE REGULATED
T/F All dietary supplements like drugs, require FDA review and approval prior to being sold in the marketplace.
FALSE:DO NOT REQUIRE
T/F Efficacy data are needed before dietary supplements are sold.
FALSE
T/F There are DS products on the market that may intentionally and or unintentionally contain ingredients that can cause health problems.
TRUE
Whose role?
-set standards for quality, purity, identity, strength, labeling, packaging for drug products
USP
Whose role?
-to ensure the safety of the patients by enforcing laws (by the FDA) and USP standards
government
Whose role?
-make a product of good quality to make money (to be successful)
manufacturer
Whose role?
-listen to their patients (be aware of what our patients are telling us) and evaluate if the product they are receiving is a quality product
pharmacist
Whose role?
-responsibility to purchase their product from an authorized supplier
Patient
What is Promoting the Quality of Medicines?
program that collaborates with developing countries to provide quality medications to their patients living in the country
TQC?
Total Quality Control: every person who works for that company has to be trained on what quality is
Which drug recall is the most serious?
Class I: involve getting the drug back from the patient
T/F USP is a governmental organization
FALSE: private non-governmental organization
According to the National Health and Nutrition Examination Survey there is a ______in the use of DS
increase
About _____ the people in the US use dietary supplements
half
WOMEN OR MALE seem to take DS more often
WOMEN
Why do about half of the people taking DS take DS?
to maintain overall health and wellness
Why do most elderly patients take DS? (4)
- eye
- joint
- bone
- heart health
Where do most people receive information about DS?
- physician (highest)
- pharmacist (lowest)
