Herbals general info Flashcards
dietary supplement and health education act
FDA created dietary supplement category in 1994
requires no proof of efficacy and safety
sets no standards for quality control
exempt from pharmaceutical regulations
products can not promise a cure on the label
they can claim effect but not “treat disease”
herbal regulation
consumers do not know if: active ingredients are in product dosage is appropriate each bottle has same components pill has contaminants
quality control
don’t know if potency is affected by growing conditions, handling, preparation
inaccurate labeling
contamination with other substances
safety studies
safety studies aren’t profitable
little motivation to conduct studies b/c they aren’t required to, cannot recoup cost
claims of efficacy are supported by anecdotal reports
toxicities
all conventional drugs have potential toxicities but:
toxicities are defined by trials
each pill has same ingredients
FDA used to post toxicity warning signs online, not anymore
classification of herbal safety and toxicity
Class 1: safe when appropriately used
Class 2: restrictions unless otherwise directed
2a: external use only
2b: not to be used if pregnant
2c: not to be used while nursing
Class 3: to be used only under supervision of expert
Class 4: insufficient data is available
herbal epidemiology
$63 million spent on herbal/dietary supplements in 2003
38% of US pop. use some kind of alternative therapy
70 million Americans are taking herbs
23% of surgery patients use herbals, 50% of them take multiple herbals, 25% of them take herbals and prescriptions together
70% of patients on herbals don’t report it to physician/anesthesia
profile of herbal user
female (shocker) 40-60 years old Caucasians, African Americans college educated patient's undergoing neurosurgical and obstetric/gynecological procedures elderly diabetics
how early to discontinue herbals before surgery?
14 days
