Dietary Supplements & Nutraceuticals Flashcards
Define a dietary supplement.
a) A product intended to supplement the diet that contains one or more of the dietary ingredients including vitamins, minerals, amino acids, herbs and other botanicals.
b) A dietary substance for use to supplement the diet by increasing the total dietary intake
c) A concentrate, metabolite, constituent, extract or combination of any ingredients above
Considered neither drug nor food.
Define nutraceuticals.
Medicinally or nutritionally functional foods
A product produced from foods but is sold in pills, powders, etc not generally associated with food.
Define functional foods.
Foods that have components incorporated to give a specific medical or physiological benefit, other than purely nutritional benefit
What does alternative medicines include?
All of the approached sand techniques that nail the past few years were not taught in medical schools.
Hypnosis, meditation, relaxation therapies, chiropractic manipulation, acupuncture, massage, herbal remedies, diet and nutrition.
What are some examples of categories where dietary supplements can be derived from?
Vitamins, minerals, amino acids, plant derivatives (botanical or herbs), thyroid derivatives
What is an example of a animal derivative?
Glucosamine and chondroitin sulfate for cartilage formation and repair.
Found in crab/lobster shells and animal cartilage, respectively.
What are the five main dosage for used for supplement?
Water extracts Hydro alcoholic extracts Glycerites Solid dosage forms Topical preparations
Infusions and decoctions are further divisions in what dosage form?
Extracts
This preparation is made by pouring boiling water over herbs and letting it steep, with water-soluble constituents being extracted,
Infusions (teas)
This preparation is normally made by pouring boiling water over herb, let it simmer and then removing the bulk plant material. Good for roots and barks
Decoctions
Tinctures and fluid extracts belong in what dosage form group?
Hydroalcoholics
How are tinctures made?
Using concentrated alcohol in varying proportions with water a solvents for the extraction process. Appropriate in water-insoluble ingredients
Glycerin is considered a poor solvent for many active ingredients found in herbs but may be used in what preparations?
Pediatric preparation due to its sweet taste. But are less stable than alcohol preparations.
What are still considered the principle dosage form for dietary supplements and nutraceuticals?
Tablets and capsules
What are the benefits of solid dosage forms?
Herb powders can easily fill capsules without extraction
Extracts can b absorbed onto regular tablet diluent said
Coated tablets improve stability and compatibility of active ingredient
Essential oils can be formulated into soft gelatin capsules
What are topical products generally intended for?
Cosmetic purposes. Products for systemic absorption and therapeutic outcome is rare.
What are some challenges in regards to dietary supplements and nutraceuticals for the FDA?
Quality control and standardization
What is the main concern in regards to quality assurance in dietary supplement and nutraceuticals?
Whether or not the correct ingredient is used.
Incorrect ingredients ca be used via adulteration, erroneous substitution of products or lack of routine testing
What can affect the potency in raw compounds?
Species variety, growing conditions, harvest time, drying/storage/handling/processing procedures.
Do herbalists believe that one active ingredient or multiple are needed to be effective?
Multiple active ingredients; many herbalists believe the hole plant or a combo of numerous plants contribute to efficacy of product.
Define standardization.
Process by which all batches of a dietary supplement produced by a single manufacturer contain the same amount of active ingredient.
Dietary supplements don’t require standardization
Product quality is uncertain in dietary supplements. What can be the result of this?
Whether the active ingredient are present or just placebo
Whether the ingredients are bioavailable
Whether dose is appropriate or each batch contains same components at same strength
May vary between manufacturers (bioequivalency)
If a product is considered a drug under the Canadian Health Protection Branch, what must the manufacturer provide?
Must prove safety, efficacy, standardization, and stability of the active ingredient to be known as a therapeutic
The US’s Dietary Supplement Health and Education Act classifies herbals as dietary supplements, not allowing them to do what?
Make any claim of therapeutic efficacy, only claims of effects on body structure or function.
Ex) St. John’s Wort enhances mood (cannot claim to treat depression)
What are the study flaws of natural products?
Non-randomization, being unblinded, lack of standardized products, small sample sizes, short treatment durations, poorly defined inclusion and exclusion criteria
When are adverse reactions normally seen and what are some reasons that they occur?
When taken at higher doses or SE.
Allergic reactions, supplements containing unidentified or toxic substances, interactions between supplements and regular meds
What are some side effects that can occur?
Hypertension, euphoria, edema, and diarrhea (ginseng root)
Headache, excitability, insomnia, cardiac disturbances(valerian)
Why should most dietary supplements be avoided in pregnancy?
They may have emmenagogue activity, promoting mestruation
Anti platelet activity is also very common.
What are some serious downsides to dietary supplements?
Are obtained anonymously and easily over the counter, heathcare practitioners must therefor rely on patients to disclose use. Pharmacist must collect accurate data from patients to ensure safety
What information should be collected, whenever possible, from patients?
Drug history, including perscription and OTC
Dietary use history (vitamins, nutraceuticals, minerals, herbs)
Drug allergy history
Reason for taking supplements and nutraceuticals
Pharmacist should always address patient in regards to the following points:
Inadequate regulations in regards to supplements
Difference in preparations from various manufacturers
Insufficient reporting of adverse events
Pharmacists should carefully evaluate the information and choose reputable sources by noting the following criteria:
Government or owner funded website
The date of last updates
Supports and references to the information
Coverage of completeness of the information (indication, MoA, CI, adverse effects, DI)
What rule should patients follow in regards to dosage?
Start at lowest recommended and increase slowly to avoid overdosing
Pharmacists can be held liable in which to treat with a dietary supplement is negligent, which may include:
Pharmacist owed the patient a duty to exercise a particular standard of care
Pharmacist breached standard of care
Substandard act of pharmacist caused harm
