Herbals Flashcards
1
Q
CAM (4)
A
- Complementary and Alternative Medicine
- Complementary: used with conventional meds
- Alternative: used in place of conventional meds
- Integrative: conventional meds with evidence based safe and effective CAM therapies
2
Q
How does VE Tyler define herbal remedies? (2)
A
- Crude drugs of vegetable origin
- Utilized for treatment of disease states of chronic nature or to attain/maintain health
3
Q
How do US regulations define herbal remedies? (3)
A
- Products taken by mouth that contain a “dietary ingredient” intended to supplement the diet.
- May be vitamins, minerals, herbs, botanicals, AAs, enzymes, organ tissues and metabolites
- Tobacco is NOT an herbal remedy (TQ)
4
Q
Characteristics of pharmaceutical medicines (4)
A
- Active constituents are highly purified, single compounds
- Well-defined, specific activity
- Doses are precisely calibrated
- Potency is greater
5
Q
Characteristics of Herbs compared to Pharmaceutical meds (4)
A
- More dilute (ie caffeine in coffee) [TQ]
- Hundreds of related compounds (may have >1 active ingredients or no active ingredients)
- Concentrations vary with individual plants
- Mis-identification of plants at time of collection
6
Q
Forms of Herbals (5)
A
- Teas (dried herb, distributed in coarse cut form or tea bags)
- Extracts (concentrated preperations: fluids, powders, solids, volatile oils)
- Oil Macerations
- Fresh expressed juice
- Tinctures (herb + alcohol)
7
Q
5 Reasons Patients Use Herbals
A
- To control one’s own health
- To build resistance to disease (homeopathy)
- “Natural” must be better
- Disappointment/Fear with allopathic medicine
- Multicultural influences
8
Q
DSHEA (6)
A
- Dietary Supplement Health and Education Act - ‘94 (TQ)
1. Regulates dietary supplements as foods
2. Removes them from regulations as pharmaceuticals
3. Requires FDA to assess reasonable expectation of safety of new ingredients (although not prior to marketing)
4. There is no pre-approval review process
5. Proof of effectiveness is not required as long as there is no claim of curative or preventative use
6. Must state a disclaimer that it hasn’t been approved by FDA and is not intended to diagnose, treat or prevent any disease (TQ)
9
Q
GMP (5)
A
- Good Manufacturing Practices
- Described by FDA
- Requirements for quality control procedures, manufacturing plants, and testing of ingredients/products
- Requirements for record keeping and handling consumer product complaints
- Some manufacturers voluntarily follow drug GMPs which are more rigorous, and some organizations have created unofficial GMPs
10
Q
USP Certification (3)
A
- Dietary Supplement Verification Program (TQ)
- Tells consumer that product contains the stated ingredients, is pure and meets limits for contaminants (TQ)
- Assesses quality and conformity of ingredients
11
Q
Problems with Herbal Medications (3)
A
- Manufacturers: minimal financial incentive to conduct clinical studies since you can’t patent)
- Lack of assurance regarding safety and efficacy of products
- Long-term uses has been associated with increased risk of total mortality in older women
12
Q
Safety Issues with Herbals (13)
A
- Lack of clinical trials
- Unknown/Inconsistent dosage guidelines
- ADME questions
- Unknown consequences of long term therapy (TQ)
- Not for children under 3
- Sold by lay persons
- Lack of information available to patient
- No guidelines for what to do if remedy fails
- Contamination/Adulteration is possible and not detected (TQ)
- high levels of heavy metals (TQ)
- No standardization of active ingredients
- Nomenclature and chemical constituents vary
- May have drug interactions (TQ)
- ADRs are unknown/underreported
13
Q
Common Uses of Herbals (7)
A
- Cold/Flu
- Colic
- Dietary concerns
- Performance enhancement
- Psych issues (ADHD, depression)
- Sleep
- Superficial injuries (cuts, burns)
14
Q
Contamination/Adulteration of Herbals (3)
A
- High levels of heavy metals found in traditional Chinese/Indian herbals (TQ)
- Some products have been adulterated with drugs (may contain sibutramine, niacin, sildenafil, glyburide, etc)
- May contain pesticides, molds, microbes
15
Q
Increased Risk for Toxicity (4)
A
- Unborn, babies, breast-feeding babies
- Elderly
- Herb consumption: high dose, multiple compounds, long-term use
- Herb/Drug interactions
