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What You Need to Know
About Dietary Supplements
Lyndsey N. Hogg, PharmD, BCACP
Clinical Pharmacy Specialist, Ambulatory Care
Via Christi Clinic, P.A.1 July 8th, 2014
2
Introductions and Disclosures
 About the Speaker
 Clinical Pharmacist at Via Christi Clinic
 Doctor of Pharmacy (PharmD)
 Board Certified Ambulatory Care Specialist (BCACP)
 Disclosures
 Dr. Hogg has nothing to disclose concerning possible financial or personal relationships with
pharmaceutical manufacturers that may have a direct or indirect interest in the subject matter of this
presentation
 Via Christi Health and Dr. Hogg do not endorse any specific medications or indications which may be
discussed during today’s presentation.
 Always discuss with your health care provider(s) before starting, stopping, or changing any medications or
dietary supplements.
3
Today’s Goals
1) Provide you with knowledge to safely
utilize dietary supplements
2) Guide you to reliable resources
3) Inform you on questions to ask about
dietary supplements & medications
4
Interesting Facts
 More than 50% of Americans use dietary
supplements on a regular basis
 Regulated as foods, not drugs
5
Key Points
 Do not self-diagnose any health condition
 Check with your health care providers
before starting any supplements
 Supplements should not replace
prescribed medications or a healthy diet
 Do your research- use reliable sources
What are Dietary
Supplements?
6
Dietary Supplements
 Dietary supplements
include:
 Vitamins
 Minerals
 Herbals & botanicals
 Amino acids
 Enzymes
 Many other products
 Variety of forms:
 Tablets
 Capsules
 Powders
 Drinks
 Energy bars
7
8
Who Regulates Supplements?
 U.S. Food & Drug Administration (FDA)
 Different set of regulations compared to
“conventional” foods & drug products
9
Supplements: How are they
different from drugs?
 Research studies to prove safety are
not required
 FDA cannot take action against manufacturer until
after product is marketed
 Proven efficacy is not required
 All claims must be followed by statement:
This statement has not been evaluated
by the Food and Drug Administration.
This product is not intended to diagnose,
treat, cure, or prevent any disease
10
Which Products Do I Buy?
 “Seals of Approval”
 U.S. Pharmacopeia
 NSF International
 Consumerlab.com
 Seal of approval does NOT mean “safe & effective”.
Rather provides assurance the product:
 Was properly manufactured
 Contains listed ingredients
 Does not contain harmful levels of contaminants
Determining What’s
in a Supplement
11
12
RDA vs. DV
 RDA: Recommended Daily Allowance
 Food & Nutrition Board at the Institute of Medicine of
the National Academies
 Vary by age, gender and pregnancy status
 Recommended intake amount of nutrient per day
 DV: Daily Value
 Food & Drug Administration
 Do NOT vary by age or gender
(one DV for anyone >4 years old)
 Suggest how much nutrient per serving
 Often match or exceed RDA for most people
13
Reading a Supplement Label
Serving Size
varies among
products
% DV
Not the RDA
Supplement
Components
Fillers,
binders,
flavors, etc.
Adapted from FDA’s “Dietary Supplement Labeling Guide”
Dietary Supplements
 Don’t replace variety of foods important to a
healthy diet
 Dietary Guidelines for Americans
 Choose MyPlate
 Natural does NOT
mean safe
14
15
Brief Overview of
Select Supplements
16
Calcium
 Use
 Osteoporosis (prevention & treatment)
 Evidence
 Well-documented: adequate intake is important for
keeping bones strong & reducing bone loss
 Regular weight-bearing & muscle-strengthening
exercises are also important
17
How Much Calcium Should I Take?
Age RDA for Men1 RDA for Women1
19-50 1,000 1,000 mg
51-70 1,000 mg 1,200 mg
71+ 1,200 mg 1,200 mg
1
1
300
200
750
Estimating your daily calcium intake:
Table & Recommended Daily Allowances (RDA) obtained from National Osteoporosis Foundation:
Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014 Issue, Version 1)
18
Forms of Calcium
 Carbonate
 Most common (inexpensive & convenient)
 Take with food for best absorption
 Tends to cause more side effects (bloating,
constipation)
 Citrate
 Take with or without food
 Other forms: gluconate, lactate, phosphate
19
Tips on Taking Calcium
 Optimizing your calcium intake
 No more than 500 mg per dose (your body can’t
absorb more than this at one meal)
 Take at separate time from multivitamin
 Calcium can decrease absorption of:
 Certain antibiotics (Levaquin, tetracycline)
 Bisphosphonates (Fosamax, Boniva, etc)
 Levothyroxine (Synthroid)
 Phenytoin (Dilantin)
20
Vitamin D
 Use
 Bone health
 Helps with calcium absorption
 Daily requirements
 National Osteoporosis Foundation
• <50 years: 400-800 IU/day
• 50 years & older: 800-1000 IU/day
 Institutes of Medicine Dietary Reference Intake
• <70 years: 600 IU/day
• 71 & older: 800 IU/day
 Most people with osteoporosis need >1000 IU/day
21
Folate (Folic Acid)
 Critical for women of child-bearing potential
 prevention of certain birth defects (spina bifida
and anecephaly)
 Recommended intake
 Childbearing potential: 400 mcg/day
 Pregnant: 600 mcg/day
 Most women will not obtain sufficient amounts
through their diet alone
22
Black Cohosh
 Reported Uses:
 Menopausal symptoms
 Evidence
 Preliminary evidence encouraging but not sufficient
(use < 6 months)
 Side Effects
 Few reported (stomach upset, headaches)
 Long-term safety data unavailable
 Who should not take it:
 Pregnant women
 Breast cancer
 Liver disorders
23
Cranberry
 Reported Uses:
 urinary track infections
 Evidence
 Prevention- preliminary evidence not definitive
 Treatment- not effective
 Side effects
 Stomach upset or diarrhea (when used in excess)
 Who should not take it:
 Those taking warfarin (Coumadin)
 Possibly those on medications which affect the liver
24
Vitamin C
 Reported Uses:
 Common cold
 Evidence
 Prevention: data does not support
 Duration/severity: no effect to mild
effect
Foods Containing Vit C† Amount of Vit C†
Citrus fruits Medium orange = 70 mg
Red & green peppers ½ cup red pepper = 96 mg
Other fruits & veggies
(broccoli, strawberries,
cantaloupe, tomatoes, etc)
½ cup broccoli = 39 mg
½ cup strawberries = 40mg
Medium tomato = 17 mg
Fortified foods & beverages
Recommended Amount†
Adult women 75 mg
Pregnant
women
85 mg
Breastfeeding
women
120 mg
Smokers add 35 mg
† National Institutes of Health Office of Dietary Supplements- “Vitamin C Quick Facts”
25
Fish Oil & Omega-3 Fatty Acids
 Side effects
 Bad breath, belching, heartburn, nausea, loose stools
 Who should not take it:
 Fish or seafood allergy
 Liver disease
 Possibly those at high bleeding risk
Reported Uses† Evidence†
Heart disease Reduces all-cause mortality
High cholesterol May lower triglycerides
(dose-dependent)
Cognitive function (memory) Inadequate evidence
Asthma No conclusions possible
† National Institutes of Health Office of Dietary Supplements- “Summary of AHRQ Report on Omega-3”
26
Glucosamine/Chondroitin
 Reported Uses
 Osteoarthritis
 Evidence
 Does not slow joint destruction or relieve pain†
 Pregnancy
 Use caution
 Who should not take it:
 Allergy to shellfish (glucosamine)
† National Institutes of Health Office of Dietary Supplements- “Summary of GAIT Study”
27
Coenzyme Q-10
 Reported Uses:
 Heart disease
 Drug-induced muscle weakness (e.g. statins)
 Reproductive disorders
 Cancer
 Evidence varies among uses
 Side effects
 No serious effects reported
 Insomnia, rash, nausea, dizziness, headache
 Use during pregnancy or breastfeeding- NO
28
Interactions
29
Interactions with
Dietary Supplements
 Warfarin (Coumadin®) +
many herbal products
 Co Q-10
 Ginkgo Biloba
 Ginseng
 Green Tea
 St. John’s Wort
30
Examples of Interactions
Rx Medications Dietary Supplement Possible Effect
Propranolol (blood pressure) Vitamin C Increased blood pressure
(avoid >500mg/day vit C)
Coumadin- aka warfarin
(blood thinner)
Cranberry
Ginkgo biloba
Increased risk of severe
bleeding (avoid combo)
Prilosec- aka omeprazole
(reflux or heart burn)
Ginkgo biloba Decreased ability to reduce
reflux (avoid combo)
Aspirin, ibuprofen
(pain relievers)
Ginkgo biloba Increased risk of bleeding
(avoid combo)
Levaquin- aka levofloxacin
(antibiotic)
Calcium-containing
products
Decreased antibiotic effect
(avoid calcium during
antibiotic course)
Coumadin, Prograf.
Simvastatin, Zoloft, Paxil,
Allegra, Digoxin, oral
contraceptives & many
others
St. John’s Wort Various effects
31
Examples of Interactions with Food
 Warfarin & vitamin K
 Calcium-rich dairy products,
antacids, & multivitamins
+ antibiotics
 Grapefruit
 Cholesterol medicines
 Some heart medicines
32
Helpful Resources
33
Resources
 Your local pharmacist

 free mobile app “MyDS”
34
Resources
 Dietary Supplement Label Database (NIH)
 Searchable database for products, ingredients,
health-related claims, label statements
35
Other Reliable Sources
 NIH fact sheets
 Nutrient recommendations (NIH)
 PubMed Dietary Supplement Subset
 MedlinePlus (National Library of Medicine)
 Food & Drug Administration
 Federal Trade Commission
36
Tips on Searching the Web for
Information on Supplements
 Questions to think about:
 Who operates the website?
 What is the purpose of the website?
• Educate the public vs sell a product
 What is the source of the information & is it
referenced?
• Reputable peer-reviewed journals
 Is the information current?
 How reliable is the internet or e-mail solicitations?
• UPPERCASE LETTERS & LOTS OF !!!!!!!!!!!!
Questions adapted from FDA.gov
37
More Tips
 Ask yourself: Does it sound too good to be true?
 Think twice about chasing the latest headline
 Contact manufacturer for more information
 Check your assumptions:
 “Even if a product may not help me, it at least won’t
hurt me.”
 “When I see the term ‘natural’, it means that a product
is healthful and safe.”
 “A product is safe when there is no cautionary
information on the product label.”
Questions adapted from FDA.gov
Video Quiz
Federal Trade Commission’s
7 Point ‘Gut Check’
38
39
Questions
to Ask
40
Questions?
 Who Should I Ask?
 Your doctor or other provider
 Your pharmacist
 When should I ask?
 New medication started
 Medication stopped
 Medication dose change
 Significant change in diet
41
General Questions to Ask
 What is the name of my medicine?
 Why am I taking this medicine?
 How much do I take and how often?
 What side effects are possible?
What should I do if they occur?
 What should I do if I miss a dose or double
the dose?
 Is there anything I should avoid while taking
this medicine?
42
Questions About Interactions
 Is the interaction something my doctor can
monitor for or should the medication/food
be stopped?
 If I take them at different times, will this prevent
the interaction?
 What side effects should I watch for? What
should I do if they occur?
A few highlights from today
43
44
Key Points
 Dietary supplements do not replace necessary
medications
 Do your research- utilize reliable resources
 Natural ≠ safe
 Some dietary supplements can interact with
prescription medications
 Notify all providers of your current medications
 ALWAYS ask your pharmacist or provider before
starting (or stopping) dietary supplements
45
Tips from a
Pharmacist
46
Know Your
Medicines
47
Electronic Medication Record
http://www.fda.gov/downloads/AboutFDA/Rep
ortsManualsForms/Forms/UCM095018.pdf
48
Utilizing Technology
 MyMedSchedule.com
 Mobile phone
applications
 Email and text
reminders
49
Tips from a Pharmacist
 Keep a list of ALL your medications
This includes vitamins & supplements!
 Keep copies in your wallet & at your house
 Take to all provider appointments
 Track any changes
 Update after each provider appointment
 Take medications exactly as prescribed
50
Tips from a Pharmacist
 Use ONE pharmacy
 Check medications before leaving the pharmacy
 All necessary refills present?
 Any medications that were stopped?
 When a medication is stopped:
 Cancel automatic refills
 Update medication list
51
Summary
Know Your
PHARMACIST
Know Your
MEDICINE
(and supplements)
Thank You!
52
What You Need to Know
About Dietary Supplements
Lyndsey N. Hogg, PharmD, BCACP
Clinical Pharmacy Specialist, Ambulatory Care
Via Christi Clinic, P.A.53 July 8th, 2014

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What you need to know about dietary supplements

  • 1. What You Need to Know About Dietary Supplements Lyndsey N. Hogg, PharmD, BCACP Clinical Pharmacy Specialist, Ambulatory Care Via Christi Clinic, P.A.1 July 8th, 2014
  • 2. 2 Introductions and Disclosures  About the Speaker  Clinical Pharmacist at Via Christi Clinic  Doctor of Pharmacy (PharmD)  Board Certified Ambulatory Care Specialist (BCACP)  Disclosures  Dr. Hogg has nothing to disclose concerning possible financial or personal relationships with pharmaceutical manufacturers that may have a direct or indirect interest in the subject matter of this presentation  Via Christi Health and Dr. Hogg do not endorse any specific medications or indications which may be discussed during today’s presentation.  Always discuss with your health care provider(s) before starting, stopping, or changing any medications or dietary supplements.
  • 3. 3 Today’s Goals 1) Provide you with knowledge to safely utilize dietary supplements 2) Guide you to reliable resources 3) Inform you on questions to ask about dietary supplements & medications
  • 4. 4 Interesting Facts  More than 50% of Americans use dietary supplements on a regular basis  Regulated as foods, not drugs
  • 5. 5 Key Points  Do not self-diagnose any health condition  Check with your health care providers before starting any supplements  Supplements should not replace prescribed medications or a healthy diet  Do your research- use reliable sources
  • 7. Dietary Supplements  Dietary supplements include:  Vitamins  Minerals  Herbals & botanicals  Amino acids  Enzymes  Many other products  Variety of forms:  Tablets  Capsules  Powders  Drinks  Energy bars 7
  • 8. 8 Who Regulates Supplements?  U.S. Food & Drug Administration (FDA)  Different set of regulations compared to “conventional” foods & drug products
  • 9. 9 Supplements: How are they different from drugs?  Research studies to prove safety are not required  FDA cannot take action against manufacturer until after product is marketed  Proven efficacy is not required  All claims must be followed by statement: This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease
  • 10. 10 Which Products Do I Buy?  “Seals of Approval”  U.S. Pharmacopeia  NSF International  Consumerlab.com  Seal of approval does NOT mean “safe & effective”. Rather provides assurance the product:  Was properly manufactured  Contains listed ingredients  Does not contain harmful levels of contaminants
  • 11. Determining What’s in a Supplement 11
  • 12. 12 RDA vs. DV  RDA: Recommended Daily Allowance  Food & Nutrition Board at the Institute of Medicine of the National Academies  Vary by age, gender and pregnancy status  Recommended intake amount of nutrient per day  DV: Daily Value  Food & Drug Administration  Do NOT vary by age or gender (one DV for anyone >4 years old)  Suggest how much nutrient per serving  Often match or exceed RDA for most people
  • 13. 13 Reading a Supplement Label Serving Size varies among products % DV Not the RDA Supplement Components Fillers, binders, flavors, etc. Adapted from FDA’s “Dietary Supplement Labeling Guide”
  • 14. Dietary Supplements  Don’t replace variety of foods important to a healthy diet  Dietary Guidelines for Americans  Choose MyPlate  Natural does NOT mean safe 14
  • 16. 16 Calcium  Use  Osteoporosis (prevention & treatment)  Evidence  Well-documented: adequate intake is important for keeping bones strong & reducing bone loss  Regular weight-bearing & muscle-strengthening exercises are also important
  • 17. 17 How Much Calcium Should I Take? Age RDA for Men1 RDA for Women1 19-50 1,000 1,000 mg 51-70 1,000 mg 1,200 mg 71+ 1,200 mg 1,200 mg 1 1 300 200 750 Estimating your daily calcium intake: Table & Recommended Daily Allowances (RDA) obtained from National Osteoporosis Foundation: Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014 Issue, Version 1)
  • 18. 18 Forms of Calcium  Carbonate  Most common (inexpensive & convenient)  Take with food for best absorption  Tends to cause more side effects (bloating, constipation)  Citrate  Take with or without food  Other forms: gluconate, lactate, phosphate
  • 19. 19 Tips on Taking Calcium  Optimizing your calcium intake  No more than 500 mg per dose (your body can’t absorb more than this at one meal)  Take at separate time from multivitamin  Calcium can decrease absorption of:  Certain antibiotics (Levaquin, tetracycline)  Bisphosphonates (Fosamax, Boniva, etc)  Levothyroxine (Synthroid)  Phenytoin (Dilantin)
  • 20. 20 Vitamin D  Use  Bone health  Helps with calcium absorption  Daily requirements  National Osteoporosis Foundation • <50 years: 400-800 IU/day • 50 years & older: 800-1000 IU/day  Institutes of Medicine Dietary Reference Intake • <70 years: 600 IU/day • 71 & older: 800 IU/day  Most people with osteoporosis need >1000 IU/day
  • 21. 21 Folate (Folic Acid)  Critical for women of child-bearing potential  prevention of certain birth defects (spina bifida and anecephaly)  Recommended intake  Childbearing potential: 400 mcg/day  Pregnant: 600 mcg/day  Most women will not obtain sufficient amounts through their diet alone
  • 22. 22 Black Cohosh  Reported Uses:  Menopausal symptoms  Evidence  Preliminary evidence encouraging but not sufficient (use < 6 months)  Side Effects  Few reported (stomach upset, headaches)  Long-term safety data unavailable  Who should not take it:  Pregnant women  Breast cancer  Liver disorders
  • 23. 23 Cranberry  Reported Uses:  urinary track infections  Evidence  Prevention- preliminary evidence not definitive  Treatment- not effective  Side effects  Stomach upset or diarrhea (when used in excess)  Who should not take it:  Those taking warfarin (Coumadin)  Possibly those on medications which affect the liver
  • 24. 24 Vitamin C  Reported Uses:  Common cold  Evidence  Prevention: data does not support  Duration/severity: no effect to mild effect Foods Containing Vit C† Amount of Vit C† Citrus fruits Medium orange = 70 mg Red & green peppers ½ cup red pepper = 96 mg Other fruits & veggies (broccoli, strawberries, cantaloupe, tomatoes, etc) ½ cup broccoli = 39 mg ½ cup strawberries = 40mg Medium tomato = 17 mg Fortified foods & beverages Recommended Amount† Adult women 75 mg Pregnant women 85 mg Breastfeeding women 120 mg Smokers add 35 mg † National Institutes of Health Office of Dietary Supplements- “Vitamin C Quick Facts”
  • 25. 25 Fish Oil & Omega-3 Fatty Acids  Side effects  Bad breath, belching, heartburn, nausea, loose stools  Who should not take it:  Fish or seafood allergy  Liver disease  Possibly those at high bleeding risk Reported Uses† Evidence† Heart disease Reduces all-cause mortality High cholesterol May lower triglycerides (dose-dependent) Cognitive function (memory) Inadequate evidence Asthma No conclusions possible † National Institutes of Health Office of Dietary Supplements- “Summary of AHRQ Report on Omega-3”
  • 26. 26 Glucosamine/Chondroitin  Reported Uses  Osteoarthritis  Evidence  Does not slow joint destruction or relieve pain†  Pregnancy  Use caution  Who should not take it:  Allergy to shellfish (glucosamine) † National Institutes of Health Office of Dietary Supplements- “Summary of GAIT Study”
  • 27. 27 Coenzyme Q-10  Reported Uses:  Heart disease  Drug-induced muscle weakness (e.g. statins)  Reproductive disorders  Cancer  Evidence varies among uses  Side effects  No serious effects reported  Insomnia, rash, nausea, dizziness, headache  Use during pregnancy or breastfeeding- NO
  • 29. 29 Interactions with Dietary Supplements  Warfarin (Coumadin®) + many herbal products  Co Q-10  Ginkgo Biloba  Ginseng  Green Tea  St. John’s Wort
  • 30. 30 Examples of Interactions Rx Medications Dietary Supplement Possible Effect Propranolol (blood pressure) Vitamin C Increased blood pressure (avoid >500mg/day vit C) Coumadin- aka warfarin (blood thinner) Cranberry Ginkgo biloba Increased risk of severe bleeding (avoid combo) Prilosec- aka omeprazole (reflux or heart burn) Ginkgo biloba Decreased ability to reduce reflux (avoid combo) Aspirin, ibuprofen (pain relievers) Ginkgo biloba Increased risk of bleeding (avoid combo) Levaquin- aka levofloxacin (antibiotic) Calcium-containing products Decreased antibiotic effect (avoid calcium during antibiotic course) Coumadin, Prograf. Simvastatin, Zoloft, Paxil, Allegra, Digoxin, oral contraceptives & many others St. John’s Wort Various effects
  • 31. 31 Examples of Interactions with Food  Warfarin & vitamin K  Calcium-rich dairy products, antacids, & multivitamins + antibiotics  Grapefruit  Cholesterol medicines  Some heart medicines
  • 33. 33 Resources  Your local pharmacist   free mobile app “MyDS”
  • 34. 34 Resources  Dietary Supplement Label Database (NIH)  Searchable database for products, ingredients, health-related claims, label statements
  • 35. 35 Other Reliable Sources  NIH fact sheets  Nutrient recommendations (NIH)  PubMed Dietary Supplement Subset  MedlinePlus (National Library of Medicine)  Food & Drug Administration  Federal Trade Commission
  • 36. 36 Tips on Searching the Web for Information on Supplements  Questions to think about:  Who operates the website?  What is the purpose of the website? • Educate the public vs sell a product  What is the source of the information & is it referenced? • Reputable peer-reviewed journals  Is the information current?  How reliable is the internet or e-mail solicitations? • UPPERCASE LETTERS & LOTS OF !!!!!!!!!!!! Questions adapted from FDA.gov
  • 37. 37 More Tips  Ask yourself: Does it sound too good to be true?  Think twice about chasing the latest headline  Contact manufacturer for more information  Check your assumptions:  “Even if a product may not help me, it at least won’t hurt me.”  “When I see the term ‘natural’, it means that a product is healthful and safe.”  “A product is safe when there is no cautionary information on the product label.” Questions adapted from FDA.gov
  • 38. Video Quiz Federal Trade Commission’s 7 Point ‘Gut Check’ 38
  • 40. 40 Questions?  Who Should I Ask?  Your doctor or other provider  Your pharmacist  When should I ask?  New medication started  Medication stopped  Medication dose change  Significant change in diet
  • 41. 41 General Questions to Ask  What is the name of my medicine?  Why am I taking this medicine?  How much do I take and how often?  What side effects are possible? What should I do if they occur?  What should I do if I miss a dose or double the dose?  Is there anything I should avoid while taking this medicine?
  • 42. 42 Questions About Interactions  Is the interaction something my doctor can monitor for or should the medication/food be stopped?  If I take them at different times, will this prevent the interaction?  What side effects should I watch for? What should I do if they occur?
  • 43. A few highlights from today 43
  • 44. 44 Key Points  Dietary supplements do not replace necessary medications  Do your research- utilize reliable resources  Natural ≠ safe  Some dietary supplements can interact with prescription medications  Notify all providers of your current medications  ALWAYS ask your pharmacist or provider before starting (or stopping) dietary supplements
  • 48. 48 Utilizing Technology  MyMedSchedule.com  Mobile phone applications  Email and text reminders
  • 49. 49 Tips from a Pharmacist  Keep a list of ALL your medications This includes vitamins & supplements!  Keep copies in your wallet & at your house  Take to all provider appointments  Track any changes  Update after each provider appointment  Take medications exactly as prescribed
  • 50. 50 Tips from a Pharmacist  Use ONE pharmacy  Check medications before leaving the pharmacy  All necessary refills present?  Any medications that were stopped?  When a medication is stopped:  Cancel automatic refills  Update medication list
  • 53. What You Need to Know About Dietary Supplements Lyndsey N. Hogg, PharmD, BCACP Clinical Pharmacy Specialist, Ambulatory Care Via Christi Clinic, P.A.53 July 8th, 2014

Hinweis der Redaktion

  1. Picture from https://myds.nih.gov/en/content/background-information-botanical-dietary-supplements
  2. In the United States, the U.S. Food and Drug Administration (FDA) has regulatory responsibility for dietary supplements. FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products (prescription and over-the-counter). Under the Dietary Supplement Health and Education Act of 1994, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Manufacturers must make sure that product label information is truthful and not misleading. FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature.
  3. Research studies in people to prove that a dietary supplement is safe are not required before the supplement is marketed, unlike for drugs. It is the responsibility of dietary supplement manufacturers/distributors to ensure that their products are safe and that their label claims are accurate and truthful. If the FDA finds a supplement to be unsafe once it is on the market, only then can it take action against the manufacturer and/or distributor, such as by issuing a warning or requiring the product to be removed from the marketplace. The manufacturer does not have to prove that the supplement is effective, unlike for drugs. The manufacturer can say that the product addresses a nutrient deficiency, supports health, or reduces the risk of developing a health problem, if that is true. If the manufacturer does make a claim, it must be followed by the statement…
  4. In addition, there are a few independent organizations that offer “seals of approval” that may be displayed on certain dietary supplement products. These indicate that the product has passed the organization’s quality tests for things such as potency and contaminants. These “seals of approval” do not mean that the product is safe or effective; they provide assurance that the product was properly manufactured, that it contains the ingredients listed on the label and that it does not contain harmful levels of contaminants. The following is a list of several organizations offering these programs: Consumerlab.com approved quality product seal NSF International dietary supplement certification U.S. Pharmacopeia dietary supplement verification program
  5. From NIH ODS (http://ods.od.nih.gov/Health_Information/ODS_Frequently_Asked_Questions.aspx#Information) Q. What is the difference between the RDA and DV for a vitamin or mineral? Many terms are used when referring to either the amount of a particular nutrient (such as calcium or vitamin D) you should get or the amount in a food or dietary supplement. The two most common are the Recommended Dietary Allowance (RDA) and the Daily Value (DV). These terms can be confusing. RDAs are recommended daily intakes of a nutrient for healthy people. They tell you how much of that nutrient you should get on average each day. RDAs are developed by the Food and Nutrition Board at the Institute of Medicine of the National Academies. They vary by age, gender and whether a woman is pregnant or breastfeeding; so there are many different RDAs for each nutrient. DVs, established by the U.S. Food and Drug Administration (FDA), are used on food and dietary supplement labels. For each nutrient, there is one DV for all people ages 4 years and older. Therefore, DVs aren’t recommended intakes, but suggest how much of a nutrient a serving of the food or supplement provides in the context of a total daily diet. DVs often match or exceed the RDAs for most people, but not in all cases. DVs are presented on food and supplement labels as a percentage. They help you compare one product with another. As an example, the %DV for calcium on a food label might say 20%. This means it has 200 mg (milligrams) of calcium in one serving because the DV for calcium is 1,000 mg/day. If another food has 40% of the DV for calcium, it’s easy to see that it provides much more calcium than the first food. The FDA has a Web page that lists the DVs for all nutrients and provides additional details.
  6. Sample label from FDA’s “Dietary Supplement Labeling Guide: Chapter IV. Nutrition Labeling” (published April 2005) http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm070597.htm (website accessed 7/6/14) Even some vitamins and minerals, when taken in inappropriate amounts, can cause problems. For example, too much vitamin A can reduce bone mineral density, cause birth defects, and lead to liver damage, according to the National Academy of Sciences
  7. MyPlate By the U.S. Department of Agriculture Includes “healthy eating on a budget” From WebMD article “’Natural’ Dietary Supplements” (accessed 7/6/14) http://www.webmd.com/fitness-exercise/naturual-dietary-supplements?page=2 “Many natural products can affect your body in ways that can potentially lead to serious illness, even death. Androstenedione. A steroid precursor used by St. Louis Cardinals slugger Mark McGwire and others, claims to enhance athletic performance and boost testosterone levels. The FDA and many amateur and professional athletic organizations have banned androstenedione. But the supplement is still for sale through the Internet and other countries and many athletes use it, putting their health at risk. Not only does androstenedione boost the concentration of estrogen (a female hormone), which can lead to breast development and impotence in men, it may cause abnormal periods, deepening of the voice and increased facial hair in women. It can also lead to serious liver disease and blood clots.” Other examples in the article: ephedra (in wt loss products) & creatine (used by some athletes)
  8. Scientific evidence shows that some dietary supplements are beneficial for overall health and for managing some health conditions. For example, calcium and vitamin D are important for keeping bones strong and reducing bone loss; folic acid decreases the risk of certain birth defects; and omega-3 fatty acids from fish oils might help some people with heart disease.
  9. http://ods.od.nih.gov/factsheets/list-all/Calcium/ 99% of body’s calcium supply is in the bones; when exogenous supply is inadequate, bone tissue from the skeleton is reabsorbed in order to maintain a constant calcium level Intakes in excess of 1,200 to 1,500 mg per day may increase the risk of developing kidney stones, cardiovascular disease and stroke. Scientific evidence shows that some dietary supplements are beneficial for overall health and for managing some health conditions. For example, calcium and vitamin D are important for keeping bones strong and reducing bone loss;
  10. ***separate Ca from fluoroquinolones (Levaquin) & tetracyclines, bisphosphonates, levothyroxine, & phenytoin- as Ca decreased absorption of these drugs Calcium absorption As amt increases, % absorption decreases Absorption highest in doses <500 mg
  11. ***separate Ca from fluoroquinolones (Levaquin) & tetracyclines, bisphosphonates, levothyroxine, & phenytoin- as Ca decreased absorption of these drugs Calcium absorption As amt increases, % absorption decreases Absorption highest in doses <500 mg
  12. NOF guidelines: Chief dietary sources of vitamin D include vitamin D-fortified milk (400 IU per quart, although certain products such as soy milk are not always supplemented with vitamin D) and cereals (40 to 50 IU per serving or more), salt-water fish and liver. Some calcium supplements and most multivitamin tablets also contain vitamin D. Supplementation with vitamin D2 (ergocalciferol) or vitamin D3 (cholecalciferol) may be used. Vitamin D2 is derived from plant sources and may be used by individuals on a strict vegetarian diet. Many older patients are at high risk for vitamin D deficiency, including patients with malabsorption (e.g., celiac disease) or other intestinal diseases, chronic renal insufficiency, patients on medications that increase the breakdown of vitamin D (e.g. some antiseizure drugs), housebound patients, chronically ill patients and others with limited sun exposure, individuals with very dark skin, and obese individuals. There is also a high prevalence of vitamin D deficiency in patients with osteoporosis, especially those with hip fractures, even in patients taking osteoporosis medications. 35, 36 Since vitamin D intakes required to correct vitamin D deficiency are so variable among individuals, serum 25(OH)D levels should be measured in patients at risk of deficiency. Vitamin D supplements should be recommended in amounts sufficient to bring the serum 25(OH)D level to approximately 30 ng/ml (75 nmol/L) and a maintenance dose recommended to maintain this level, particularly for individuals with osteoporosis. Many patients with osteoporosis will need more than the general recommendation of 800-1,000 IU per day. The safe upper limit for vitamin D intake for the general adult population was increased to 4,000 IU per day in 2010.30
  13. Scientific evidence shows that some dietary supplements are beneficial for overall health and for managing some health conditions. For example, folic acid decreases the risk of certain birth defects (neural tube defects such as spina bifida & anecephaly)
  14. http://ods.od.nih.gov/factsheets/list-all/BlackCohosh/ http://ods.od.nih.gov/factsheets/BlackCohosh-HealthProfessional/ Herb Evidence- preliminary evidence encouraging but not sufficient to support recommendation for use NCCAM at NIH funding rigorous scientific study Amer. College of Obstetrians & Gynecologists- may be helpful short term (6 month) for women w/ vasomotor sx (consensus & expert opinion)
  15. http://ods.od.nih.gov/factsheets/list-all/Cranberry/ National Center for Complementary & Alternative Medicine (NCCAM) http://nccam.nih.gov/health/cranberry Future studies NCCAM funding studies to better understand effects on UTIs National Institute on Aging funding study of potential anti-aging effects
  16. http://ods.od.nih.gov/factsheets/list-all/VitaminC/ http://ods.od.nih.gov/factsheets/VitaminC-QuickFacts/ Amount needed/day Most people get enough through diet. Those who may not include: Smokers (or those exposed to 2nd hand smoke): more needed for repairing damage from free radicals Infants fed evaporated or cow’s milk Those who eat limited variety of food Certain dzs such as severe malabsorption, some types of cancer, & kidney damage requiring hemodialysis
  17. http://ods.od.nih.gov/factsheets/list-all/FishOil/ http://ods.od.nih.gov/factsheets/list-all/Omega3/ Numerous uses: Asthma No conclusions could be drawn about the value of omega-3 fatty acid supplements in the prevention or treatment of asthma for adults or children other than the fact that they have an acceptable safety profile. Cancer CV & heart dz Impact on cardiovascular disease: According to both primary and secondary prevention studies, consumption of omega-3 fatty acids, fish, and fish oil reduces all-cause mortality and various CVD outcomes such as sudden death, cardiac death, and myocardial infarction. The evidence is strongest for fish and fish oil supplements. Impact on CVD risk factors: Fish oils can lower blood triglyceride levels in a dose-dependent manner. Fish oils have a very small beneficial effect on blood pressure and possible beneficial effects on coronary artery restenosis after angioplasty and exercise capacity in patients with coronary atherosclerosis Child & maternal health Cognitive function Diabetes, IBD, RA, renal dz, systemic lupus, osteoporosis Omega-3 fatty acids can reduce joint tenderness and need for corticosteroid drugs in rheumatoid arthritis. Data are insufficient to support conclusions about the effects of omega-3 fatty acids on inflammatory bowel disease, renal disease, systemic lupus erythematosus, bone density, and diabetes. Eye health Mental health The quantity and strength of evidence is inadequate to conclude that omega-3 fatty acids protect cognitive function with aging or the incidence or clinical progression of dementia (including Alzheimer’s disease), multiple sclerosis, and other neurological diseases. Organ transplant No conclusive evidence suggests specific benefits of omega-3 fatty acid supplementation on any outcome in any form of organ transplantation. However, available studies are small, have methodological problems, and may not fully apply to current transplantation procedures
  18. http://ods.od.nih.gov/factsheets/list-all/Glucosamine/ Glucosamine- amino sugar produced by body & distributed in cartilage & other connective tissue Chondroitin- complex carbohydrate that helps cartilage retain water GAIT study http://nccam.nih.gov/research/results/gait/qa.htm For pts with mild pain- no difference for either agent alone or combo compared to placebo For pts with moderate-severe pain- statistically significant pain relief compared to placebo (NOTE small group & thus only considered a preliminary finding, more studies needed)
  19. http://ods.od.nih.gov/factsheets/list-all/CoenzymeQ10/ NIH- What you need to know: http://nccam.nih.gov/health/supplements/coq10 Antioxidant necessary for cells to function properly Used by cells to make energy they need to grow & stay healthy Levels decrease as you age Evidence HF- associated w/ improved heart function & feeling better Post bypass & heart valve surgery- CoQ10 plus other nutrients associated w/ quicker recovery HTN- mixed results Statin induced muscle weakness- mixed results (one study showed it helped ease myopathy but concluded results not definite; other study showed no better than placebo) Reproductive health- some evidence to support improved semen quality & sperm count in infertile men but not know if this affects likelihood of conception Cancer- no convincing evidence it treats or prevents cancer (although women w/ breast cancer have been show to have abnormal CoQ10 levels) Interactions Can make warfarin less effective Side effects most common side effects: insomnia, increased liver enzymes, rashes, nausea, upper abdominal pain, dizziness, sensitivity to light, irritability, headaches, heartburn, and fatigue NIH sponsoring studies investigating effects on statin-induced muscle pain, fertility in older women & breast cancer treatments
  20. can cause serious bleeding if combined with blood thinners such as warfarin
  21. Warfarin Decreased w/ vit K rich foods Increased with cranberry juice Calcium prevents antibiotic absorption (separate dosing time) Levaquin & Cipro
  22. NIH ODS “Dietary Supplement Fact Sheets”- Available for many vitamins, herbals & supplements
  23. DSLD (database from the NIH- launched June 2013) 17,000 products included initially, will grow to >55,000 products The DSLD is a collaborative project of the Office of Dietary Supplements (ODS) and the National Library of Medicine (NLM) at NIH, with input from many federal stakeholders including most NIH institutes and centers, the U.S. Department of Agriculture’s Agricultural Research Service, the Centers for Disease Control and Prevention’s National Center for Health Statistics Division of Health and Nutrition Examination Surveys, and the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition.
  24. NIH fact sheets Includes links to helpful resources and information on many dietary supplements Nutrient recommendations Includes recommended daily allowance (RDA), adequate intake (AI), & tolerable upper intake level (UL) PubMed Dietary Supplement Subset Searchable database of articles on dietary supplements Linked with Medline database MedlinePlus Searchable website which includes reliable information on health topics, drugs & supplements Federal Trade Commission- info on how to evaluate claims for products related to your health (avoiding fraudulent claims)
  25. http://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm110567.htm
  26. http://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm110567.htm
  27. http://www.consumer.ftc.gov/sites/all/libraries/games/weightlosschallenge/ 1) causes weight loss of two pounds or more a week for a month or more without dieting or exercise; 2) causes substantial weight loss no matter what or how much the consumer eats; 3) causes permanent weight loss even after the consumer stops using product; 4) blocks the absorption of fat or calories to enable consumers to lose substantial weight; 5) safely enables consumers to lose more than three pounds per week for more than four weeks; 6) causes substantial weight loss for all users; or 7) causes substantial weight loss by wearing a product on the body or rubbing it into the skin.
  28. “your pharmacist is trained to really understand what exactly a drug does, how it interacts with other drugs, and potential problems you might come across” “this might include information your doctor doesn’t know” “doctors aren’t always aware of every single possible drug interaction. So if you have a lot of prescriptions, especially if they’re from different doctors, it’s worth discussing the issue with your pharmacists because they have a lot more information than your doctor does” http://lifehacker.com/your-pharmacist-is-more-useful-than-you-think-510727546
  29. Not all interactions will cause problems but some interactions can be serious.
  30. Not all interactions will cause problems but some interactions can be serious.
  31. On average, a community pharmacy is located within two miles of every American home.
  32. Why do I need to know my medications? Doesn’t my doctor keep track of them?
  33. List should include OTCs, vitamins, herbals, supplements Using 1 pharmacy: Reduces chances for drug interactions
  34. Using 1 pharmacy: Reduces chances for drug interactions