Supplement Sense Smart Dietary Supplement Practices Presenter Name
- Slides: 38
Supplement Sense: Smart Dietary Supplement Practices Presenter Name, Title This program is made possible with the support of:
By the end of this presentation you will be able to: • Provide three requirements that define a dietary supplement • Describe two ways that a dietary supplement differs from prescription and over-the-counter (OTC) medicines • Use and interpret a dietary supplement label to select a product • List three things you can do to help ensure dietary supplement safety
What is a Dietary Supplement? • The Dietary Supplement Health and Education Act, approved by Congress in 1994, defines a dietary supplement as a product that: • Is intended to supplement the diet • Contains one or more ingredients (like vitamins, minerals, herbs, amino acids or their constituents) • Is intended to be taken by mouth • Is labeled as a dietary supplement Rickert ED. Legal and regulatory issues in self-care pharmacy practice. Handbook of Nonprescription Drugs; 2015. Tsourounis C, et al. Introduction to dietary supplements. Handbook of Nonprescription Drugs; 2015.
Who Regulates Dietary Supplements? • The Food and Drug Administration (FDA) regulates dietary supplements • Dietary supplements are regulated differently than prescription and over-the-counter (OTC) medicines • Dietary supplements are regulated as foods because they are intended to supplement the diet Rickert ED. Legal and regulatory issues in self-care pharmacy practice. Handbook of Nonprescription Drugs; 2015. Tsourounis C, et al. Introduction to dietary supplements. Handbook of Nonprescription Drugs; 2015.
Differences in Regulation Regulated As Requirements Prescription Medicines Medicine • FDA considers new drugs to be unsafe until they are proven safe through clinical trials • Intended to diagnose, treat, cure or prevent disease Over-the-counter medicines Medicine • FDA considers new drugs to be unsafe until they are proven safe through clinical trials • Intended to diagnose, treat, cure or prevent disease • You must be able to: o Self-diagnose o Self-treat o Self-manage Dietary Supplements Food • FDA considers dietary supplements safe until they are proven unsafe • Not required to test new ingredients or supplements in clinical trials • Intended to supplement the diet Rickert ED. Legal and regulatory issues in self-care pharmacy practice. Handbook of Nonprescription Drugs; 2015. Tsourounis C, et al. Introduction to dietary supplements. Handbook of Nonprescription Drugs; 2015.
Dietary Supplement Uses • Dietary supplement manufacturers are not able to claim that the product can diagnose, treat, cure or prevent disease • However, dietary supplements have been evaluated in clinical studies and therefore are commonly used to support many bodily functions and specific health needs http: //www. fda. gov/Food/Dietary. Supplements/Using. Dietary. Supplements/ucm 480069. ht m#what_is Tsourounis C, et al. Introduction to dietary supplements. Handbook of Nonprescription Drugs; 2015.
Who Uses Dietary Supplements Pregnant women Nursing mothers Strict vegetarians Senior citizens People with food allergies or intolerances Tsourounis C, et al. Introduction to dietary supplements. Handbook of Nonprescription Drugs; 2015. 2013: estimated dietary supplement use 68% of people
What are Dietary Supplements Used For? Desire to Improve Health (45%) Tsourounis C, et al. Introduction to dietary supplements. Handbook of Nonprescription Drugs; 2015. Desire to Maintain Health (33%) Promote Bone Health (25%)
What Should I Look For On the Label? • The term “dietary supplement” should be listed on the label • Contain a dietary supplement facts panel that includes amounts of all dietary ingredients • Quality Indicators – Independent verification http: //www. naturemade. com/~/media/Images/Nature. Made/PDF/Health%20 Care%20 Professionals/HCP%20 Updates%200 42315/How%20 Supplements%20 are%20 Regulated%20 Handout. ashx Look for the USP mark
What Should I Look For On the Label? • What dietary supplements cannot do: • Make claims to “diagnose, mitigate, treat, cure, or prevent disease” • Make false and misleading claims http: //www. naturemade. com/~/media/Images/Nature. Made/PDF/Health%20 Care%20 Professionals/HCP%20 Updates%20042315/ How%20 Supplements%20 are%20 Regulated%20 Handout. ashx
How to Read the Label
Dietary Supplement Label Suggested Use: How to use the product safely and correctly
Dietary Supplement Label Serving Size: How many tablets or capsules you should take %DV: Indicates the amount that the serving size represents
Dietary Supplement Label Lot Number: • Series of letters and numbers that help track a product Expiration Date: • How long the ingredients will be effective
Dietary Supplement Label Ingredients: • Vitamin or mineral ingredients in each tablet or capsule • List of potential allergens, fillers, binders, flavorings also included Manufacturer Contact Information: • Address and telephone number should be provided • Contact with questions or concerns
Dietary Supplement Safety
Tips for Using Dietary Supplements Safely • Always talk with your pharmacist and doctor before starting or stopping a dietary supplement • This is especially important when: • A supplement contains an ingredient that is used for the same reason as another medicine you are taking • A supplement contains multiple ingredients • You are combining dietary supplements with prescription or over-the-counter (OTC) medicines • Report side effects to Med. Watch: FDA Safety Information and Adverse Event Reporting Program • Toll Free 1 -888 -SAFEFOOD, 1 -888 -723 -3366 PL Detail-Document, Tips for Dietary Supplement Users. http: //www. fda. gov/Food/Dietary. Supplements/Report. Adverse. Event/default. htm
Are Dietary Supplements Safe? • Yes, when used responsibly in moderation and with careful monitoring • Despite good manufacturing practice rules, supplements may be found to contain contaminants, impurities and harmful ingredients • Both intentional and unintentional contamination can occur • 20% of all cases of liver damage in the US are from dietary supplements; this is up from 7% from 2004 • Can interact with prescription medicines Tsourounis C, et al. Introduction to dietary supplements. Handbook of Nonprescription Drugs; 2015. Navarro V, et al. Liver Injury from Herbal and Dietary Supplements. Hepatology. 2016 Sep 27. doi: 10. 1002/hep. 28813
Look-Alike, Sound-Alike Dietary Supplements • Dietary supplements that start with the same letters • For example: “gin” • Ginkgo and Ginseng • Dietary supplements with very similar names/spellings • For example: DHEA and DHA PL Detail-Document, Look-Alike, Sound-Alike Supplements. Natural Medicines
Common Interactions with Dietary Supplements
Medicines that Interact with Dietary Supplements • Birth Control Pills/Morning After Pill • Some dietary supplements may speed up how quickly birth control pills are removed from the body • This increases the chance of pregnancy • St. John’s wort supplements that contain the ingredient hyperforin interfere with birth control pills • Do not combine birth control pills with St. John’s wort http: //www. naturemade. com/~/media/Documents/Health%20 Care%20 Professionals/072016/ Common%20 Drug%20 Nutrient%20 Depletions%20 and%20 Interactions. ashx
Medicines that Interact with Dietary Supplements • Warfarin (Coumadin®) • The INR is a test that measures how quickly your blood clots • The INR is used to help determine the dose of warfarin • Many medicines interact and can increase or decrease your INR test • Coenzyme Q 10, Cranberry, Vitamins E & K, Garlic (raw garlic and garlic extracts, Fish Oil http: //www. naturemade. com/~/media/Documents/Health%20 Care%20 Professionals/072016/ Common%20 Drug%20 Nutrient%20 Depletions%20 and%20 Interactions. ashx
Medicines that Interact with Dietary Supplements • Some dietary supplements may block how platelets work • Ineffective platelets can’t stop bleeding once it begins • Vitamin E (800 Units or more per day) • Vitamin K • Garlic (raw garlic and garlic extracts) • Very high doses of fish oil (although evidence of this interaction is not that strong) http: //www. naturemade. com/~/media/Documents/Health%20 Care%20 Professionals/072016/ Common%20 Drug%20 Nutrient%20 Depletions%20 and%20 Interactions. ashx
Commonly Used Dietary Supplements
Multivitamins • Vitamins are nutrients that our body does not make on its own; we must obtain them from the foods we eat, or through supplements • They are essential for providing good health and are necessary for many life functions • Not everyone needs a multivitamin • Supplements are best when accompanied by a well balanced diet • Supplements should not replace a healthy diet • Food provides calories and energy that are required for daily activities, vitamin • Supplements do not provide energy or calories • Some people do need a multivitamin www. choosemyplate. gov www. nutrition. gov
Fish Oil (Omega-3 Fatty Acids) • How it works: Supports various aspects of health including roles in cell membrane fluidity & function, anti-inflammation pathways, and cardiovascular health • Effects: Majority of research focus on heart health benefits • FDA Qualified Health Claim for EPA &DHA omega-3 fatty acids and Coronary Heart Disease • Look for EPA and DHA within the ingredient list • Safety: Common supplementation doses (500 – 1000 mg) are well-tolerated and equate to dietary recommendations of 2 servings of fatty fish per week
Garlic • How it works: used for heart health area to support normal cholesterol levels • Effects: May have garlic breath and body odor even with tablets; rarely nausea, low blood pressure • Safety: Generally safe, but can interact with many medicines • Warfarin, blood thinners, some HIV medicines Garlic for lowering blood pressure. Pharmacist’s Letter/Prescriber’s Letter 2008; 24(10): 241076. Natural Medicines
Melatonin • How it works: natural substance made in the brain’s pineal gland • Works quickly (within 30 – 60 minutes); take once nightly 30 minutes before desired bedtime • Helps people fall asleep faster, better sleep and helps with daytime alertness • Well tolerated; rarely headache, nausea, some drowsiness and dizziness • May worsen mood in people who suffer from dementia (a decline in memory and thinking) Natural Medicines
Glucosamine Sulfate • How it works: amino-sugar naturally produced by cartilage cells serves as cartilage nutrient • Glucosamine sulfate is the most well studied form • May lead to less pain and stiffness; can take 1 to 2 months to see a difference • Well tolerated; rarely upset stomach, headache, constipation/diarrhea • Keep a diary of mobility, stiffness, pain Natural Medicines
Dietary Supplements To Avoid • Products claiming to be alternatives to FDA-approved drugs or to have effects similar to prescription drugs • Products claiming to be a legal alternative to anabolic steroids • Products that are marketed primarily in a foreign language or those that are marketed through mass e-mails • Sexual enhancement products promising rapid effects, such as working in minutes to hours, or long-lasting effects, such as working for 24 to 72 hours • Product labels warning that you may test positive in performance enhancement drug tests • Weight loss supplements as they have not been proven more effective than diet and exercise http: //www. fda. gov/For. Consumers/Consumer. Updates/ucm 246744. htm
Summary • Scientists are just now beginning to study dietary supplements • There is much that we don’t know: • What is the exact active ingredient in a plant with thousands of chemicals? • What dose of this active ingredient is best in order to see an effect? • What dose is unsafe? • How do these active ingredients affect pregnancy? • Can supplement ingredients be transferred through a mother’s milk to the infant? • Do these active ingredients help some cells and harm other cells in the body?
Summary • Dietary supplements contain active ingredients just like prescription medicines and may lead to side effects and possible interactions with other medicines • Unlike prescription medicines, dietary supplements are not required to undergo testing for safety or effectiveness in clinical studies before being marketed • Always read and follow the instructions on the label • If you take supplements tell your doctor before undergoing surgery • Always talk to your pharmacist and doctor before selecting or using dietary supplements
Questions? • Your Name and Credentials • Your Practice Site [optional] • Your Contact Information [suggested] Always talk to your pharmacist!
References • Brzezinski A et al. Effects of exogenous melatonin on sleep. A meta-analysis. Sleep med Rev 2005; 9: 41 • Food, Herbs & Supplements. Natural Medicines. Therapeutic Research Center. Sommerville, MA. Available at: http: //naturaldatabase. therapeuticresearch. com/home. aspx? cs=CEPDA&s=ND Accessed October 1, 2016. • Garlic for lowering blood pressure. Pharmacist’s Letter/Prescriber’s. Letter 2008; 24(10): 241076. • How to read a vitamin label (front). Nature Made. Available at: http: //www. naturemade. com/~/media/Images/Nature. Made/PDF/Health%20 Care%20 Profession als/HCP%20 Updates%20042315/PID 5231%20 How%20 to%20 Read%20 a%20 Vitamin%20 Label% 20 Insert_Front_FNL. ashx. Accessed October 1, 2016.
References • How to read a vitamin label (back). Nature Made. Available at: http: //www. naturemade. com/~/media/Images/Nature. Made/PDF/Health%20 Care%20 Professionals/H CP%20 Updates%20042315/PID 5231%20 How%20 to%20 Read%20 a%20 Vitamin%20 Label%20 Insert_ Back_FNL. ashx. Accessed October 1, 2016. • Navarro V et al. Hepatology. 2016 Sep 27. doi: 10. 1002/hep. 28813. [Epub ahead of print] • Clarke TC, Black LI, Stussman BJ, et al. Trends in the use of complementary health approaches among adults: United States, 2002 -2012. Natl Health Stat Report. 2015 Feb 10; (79): 1 -16. • PL Detail-Document, Look-Alike, Sound-Alike Supplements. Pharmacist’s Letter/Prescriber’s Letter. September 2015. • PL Detail-Document, Omega-3 Fatty Acids. Pharmacist’s Letter/Prescriber’s Letter. August 2012. • Clegg DO, et al. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med. 2006 Feb 23; 354(8): 795 -808.
References • PL Detail-Document, Tips for Dietary Supplement Users. Pharmacist’s Letter/Prescriber’s Letter. December 2015. • Saper RB. Common dietary supplements for weight loss. Am Fam Physician. 2004 Nov 1; 70(9): 1731 -8. • PL Self-Study Course. Natural medicines in the clinical management of benign prostatic hyperplasia. 2010; 10(102). • Rickert ED. Legal and regulatory issues in self-care pharmacy practice. In: Krinksy DL, Ferreri SP, eds. Handbook of Nonprescription Drugs: An interactive approach to self-care, 18 th ed. Washington, DC: American Pharmacists Association: 2015. • Tsourounis C, Dennehy C. Introduction to dietary supplements. . In: Krinksy DL, Ferreri SP, eds. Handbook of Nonprescription Drugs: An interactive approach to self-care, 18 th ed. Washington, DC: American Pharmacists Association: 2015.
This program is made possible with the support of:
- Dietary supplement meaning
- Dietary supplement questionnaire
- Dietary supplement formulation
- Dominant genetic variance
- Narrow sense heritability vs broad sense heritability
- Qlik sense data model best practices
- Name of presentation
- Name of the presenter
- Presenter name
- Presenter name
- Name of presenter
- Presenter name
- Presenters name
- Name of presenter
- Session title examples
- Presenter company
- Younique presenter ms name
- Presenter name
- Ebcflex app
- Name/title of presenter
- Presenter's name
- Presentation name
- Name/title of presenter
- Paper presenter
- Company presenter
- Title of presentation
- Presenter's name
- Presenter title
- Presenter name
- Presenter's name
- Dietary acculturation
- Mealracker
- Scottish dietary goals 2020
- Dietary management of diabetes
- Dietary habits questionnaire
- Dietary manipulation in sport definition
- Breakfast for a sedentary worker
- Sepsis dietary management
- Vitamin k dietary sources