Herbals Flashcards
Current regulation stems from
1994 FDA created supplement category
Requires no proof of efficacy or safety
No quality controls
Exempt from pharm. regulations
Can supplements claim to cure anything?
No, but they may claim specific effects, such as “boosts immunity”
Lack of regulation leads to
Unknowns regarding- Active ingredients Bioavailability Proper dosage Consistency Contaminants
Why do manufacturers not conduct safety studies
Not required to
Expensive and unlikely to recoup the costs
Does the FDA issue warnings about potential problems with supplements?
No, in the past they did, but too numerous to continue to do so
What is the industry group that offers safety recommendations regarding supplements
American Herbal Product Association
What are the safety classes used by the AHPA
Class 1- safe when used appropriately
Class 2- External use only, not to be used when nursing/pregnant
Class 3- Only to be used under the supervision on an expert
Class 4- Insufficient data
How large is the supplement market
$63 billion in 2003
35% of the population takes some form
What percentage of patients continue to use herbals prior to surgery
About 23%
Half of those take multiple products and a quarter also take Rx drugs
What percentage of pts do not report supplement use to anesthesia providers
70%
Profile of common herbal users
Female, 40-60
White
College education
Neuro/OB/GYN procedures
Most commonly used herbals in the US
Echinacea Gingko St.John's wort Garlic Ginseng Saw palmetto Ephedra Valerian Kava
How do herbals affect periop course
Direct effects
Dynamic interactions (alters effects of other meds)
Kinetic interactions (altered metabolism/elimination of other drugs)
Specific anesthesia concerns
Prolong effects of anesthetic agents Increased bleeding risk Hypo/hypertension Hypoglycemia Hepatotoxicity
What are the current recommendations regarding herbals and surgery
Discontinue 14 days prior to surg