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-thecounter (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 Over-the-counter medicines Medicine Dietary Supplements Food 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. FDA considers new drugs to be unsafe until they are proven safe through clinical trials Intended to diagnose, treat, cure or prevent disease 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 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 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/DietarySupplements/UsingDietarySupplements/u cm480069.htm#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/NatureMade/PDF/Health%20Care%20Professionals/HCP%20Updates %20042315/How%20Supplements%20are%20Regulated%20Handout.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/NatureMade/PDF/Health%20Care%20Professionals/HCP%20Updates%20042315/ How%20Supplements%20are%20Regulated%20Handout.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 MedWatch: 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/DietarySupplements/ReportAdverseEvent/ 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. Johns wort St. Johns wort supplements that contain the ingredient hyperforin interfere with birth control pills
Do not combine birth control pills with St. Johns http://www.naturemade.com/~/media/Documents/Health%20Care%20Professionals/072016/ Common%20Drug%20Nutrient%20Depletions%20and%20Interactions.ashx wort 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 Q10, Cranberry, Vitamins E & K, Garlic (raw garlic and garlic extracts, Fish Oil http://www.naturemade.com/~/media/Documents/Health%20Care%20Professionals/072016/ Common%20Drug%20Nutrient%20Depletions%20and%20Interactions.ashx Medicines that Interact with Dietary Supplements Some dietary supplements may block how platelets work Ineffective platelets cant 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%20Care%20Professionals/072016/ Common%20Drug%20Nutrient%20Depletions%20and%20Interactions.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, antiinflammation 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. Pharmacists Letter/Prescribers Letter 2008;24(10):241076. Natural Medicines
Melatonin How it works: natural substance made in the brains 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 http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm246744.htm effective than diet and exercise
Summary Scientists are just now beginning to study dietary supplements There is much that we dont 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 mothers 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. Pharmacists Letter/PrescribersLetter 2008;24(10):241076. How to read a vitamin label (front). Nature Made. Available at: http://www.naturemade.com/~/media/Images/NatureMade/PDF/Health%20Car e%20Professionals/HCP%20Updates%20042315/PID5231%20How%20to%20R ead%20a%20Vitamin%20Label%20Insert_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/NatureMade/PDF/Health%20Care%2 0Professionals/HCP%20Updates%20042315/PID5231%20How%20to%20Read%20 a%20Vitamin%20Label%20Insert_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. Pharmacists Letter/Prescribers Letter. September 2015. PL Detail-Document, Omega-3 Fatty Acids. Pharmacists Letter/Prescribers 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. Pharmacists Letter/Prescribers 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, 18th 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, 18th ed. Washington, DC: American Pharmacists Association: 2015. his program is made possible with the support o
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