Supplements in Metabolic Disease Flashcards
Integrative Health
Healing or
Do a lot of people utilize integrative health?
No
33% of adult american population
11% of children in ‘merica
72% of patients did not report CAM use to health care provider (Complementary and Alternative Medicine)
Who are the highest utilizers of CAM?
44-65 years old
What are the IH Domains? Which are highest utilized?
- Biologically Based Systems - Most used (Herbals, Diet)
- Manipulative & Body - Based
- Mind-Body Medicine
- Alternative Medical Systems
- Energy Therapies
Why are people using IH?
- Dissatisfied with the results of conventional therapy
- Lack of disease curing
- Dramatic reports from media
- Patient empowerment
- Focused on spiritual and emotional wellbeing
What patients believe regarding supplements
- Natural is better than synthetic
- Patients don’t consider herbs as “drugs”
- Herbs don’t have side effects
- Herbs are regulated, standardized, and safe
- They’ve been used for thousands of years
Evidence of IH
Efficacy
- Folklore
- Anecdotes
- Small studies
Safety
- Inherent toxicity
- Interaction with other conventional drugs ***
Mainstream medicine
- Poppies = morphine
- Foxglove = Digoxin
- Willow bark = aspirin
- Pacific yew tree = tamoxifen
What is the role of DSHEA?
- Regulate the evaluation of vitamins, herbals, AA
Role of manufacturers vs. FDA
Manufacturers
- Do not need to register or get FDA approval
- Responsible to ensure product is safe
- Ensure product label information is truthful and not misleading
FDA
- Take action if product is unsafe once on the market *** (prescription drugs are done before)
- Monitors safety (ADR MedWatch reporting)
- Monitors product information (labeling, claims, package inserts, accompanying literature
What can be reported via MedWatch?
- Regulated drug
- Biologic
- Medical device
- Dietary supplement
What came of the White House Commision on CAM policy?
- Coordination of research to increase CAM knowledge
- Educate and train the health care practitioners in CAM
- Provide reliable and useful info about CAM practices to products and professionals
- Guidance regarding appropriate access to delivery of CAM
What are the labeling requirements for supplements?
- Disclaimer (that it isn’t meant to treat something and hasn’‘t been evaluated by the FDA)
- Structure-function claim (what to use it for)
What are Good Manufacturing Practices (GMPs)?
- Record keeping
- Quality control
- Testing
- Production
- Verify quality of raw materials
- Increase inspecting of facilities by FDA inspectors
How to determine which supplement is better?
- Good labeling
- 3rd party company studies product and receive a seal from GMP, CL, USP, NSF (the 3rd party surveyor)
- Note that United States Pharmacopoeia (USP) is the most commonly seen
How should you use supplements?
- Start low and go slow
- D/c if ineffective or unsafe
- DDIs
- Best to use single active ingredients vs. combinations (helps you figure out which ingredient is the problem)
- Purchase product from a reliable source
Use extra caution in:
- Pregnancy
- Nursing
- Elderly
- Children
- Patients with serious health problems
Most used Natural Products by US Adults
- Fish oil/omega 3/ DHA
- COQ10
- Garlic