introduction to herbal products, how to use it, what you should know about it for easy and safe use by public a lecture prepared by a clinical pharmacist

1. Herbal Products
Master of Science (Clinical Pharmacy)
School of Pharmaceutical Sciences,
Universiti Sains Malaysia, Penang, Malaysia.
E-Mail: ahmad090@Hotmail.com
What you should know about it?
Ahmed Ibrahim Nouri, PharmD

2. Outlines .
• Introduction
• Herbal Products Safety
• Herbal Products Uses
• Label of Herbal Products
• Interactions with Herbals
• Commonly used Herbals
• Summary

3. – Herbal products have gained increasing popularity in the last decade, and are now
used by approximately 20% of the population.
– Herbal products are complex mixtures of organic chemicals that may come from
any raw or processed part of a plant, including leaves, stems, flowers, roots, and
seeds.
– They are used as supplements to improve health and well being, and may be used
for other therapeutic purposes.
– Herbal products are available as tablets, capsules, powders, extracts, teas and so
on.
Introduction

4. – People have used the active ingredients in dietary supplements for
thousands of years to help health and to treat illness.
– Sometimes those supplements are the basis for some of today's common
medicines.
– For example, people have used willow bark tea for centuries to relieve
fever.
– Pharmaceutical companies eventually identified the chemical in willow bark
that relieved fever and used that knowledge to produce Aspirin
Introduction

5. The Dietary Supplement Health and
Education Act (DSHEA),1994
– Classifies herbs as dietary supplements that is intended as a supplement to the
normal diet.
– Supplements therefore include vitamins, minerals, herbs, amino acids,
enzymes, organ tissues, metabolites, extracts, or concentrates.
– Label must list each ingredient by name, quantity, and total weight and must
identify the plant parts from which each ingredient is derived

6. Herbal
products
Safety

7. – Because dietary supplements are natural, some people assume
that they are safe to use!
– a substance is not necessarily safe just because it is natural.
– Almost all substances that affect the body, whether dietary
supplements or drugs approved for medical use by the FDA can
have unwanted side effects.
Safety and Effectiveness

8. – Both prescription and non-prescription (over-the-counter) drugs studied
by researchers and reviewed for safety and effectiveness by the FDA.
– 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.
Who regulates herbs?

9. Advices for Using Dietary
Supplements Safely
– Always talk with your pharmacist and doctor before starting or stopping a dietary
supplement
– 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
PL Detail-Document,Tips for Dietary Supplement Users.
http://www.fda.gov/Food/DietarySupplements/ReportAdverseEvent/default.htm

10. So, are Dietary Supplements
Safe?
– Yes, when used responsibly in moderation and with careful
monitoring
– 20% of all cases of liver damage in the US are from dietary
supplements; this is up from 7% from 2004.
– Herbals can interact with prescription medicines,
Tsourounis C, et al. Introduction to dietary supplements. Handbook of Nonprescription Drugs; 2015.
NavarroV, et al. Liver Injury from Herbal and DietarySupplements. Hepatology. 2016 Sep 27. doi: 10.1002/hep.28813

11. Herbal
Products
Uses

12. Dietary Supplement Uses
http://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm480069.ht
m#what_is
Tsourounis C, et al. Introduction to dietary supplements. Handbook of Nonprescription
Drugs; 2015.
– A major difference between a drug and a dietary supplement is that
dietary supplements may not claim to “diagnose, cure, mitigate,
treat, or prevent illness”
– However, dietary supplements have been evaluated in clinical
studies and therefore are commonly used to support many bodily
functions and specific health needs

13. Who Uses Herbal Supplements?
Tsourounis C, et al. Introduction to dietary supplements. Handbook of
Nonprescription Drugs; 2015.
Elderly
Pregnant &Nursing
mothers
Strict vegetarians
People with food
allergies or intolerances
People who needs
GeneralWell-being
People with
Certain
medical
condition

14. What are they Used For?
Tsourounis C, et al. Introduction to dietary supplements. Handbook of
Nonprescription Drugs; 2015.
Desire to
Improve
Health
(45%)
Desire to
Maintain
Health
(33%)
Promote
Bone
Health
(25%)

15. Label of
Herbal
products

16. 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%2004
2315/How%20Supplements%20are%20Regulated%20Handout.ashx

17. - Suggested Use
How to use the product safely and correctly
How to Read the Label

18. Serving Size:
How many tablets or capsules you should take
%DV:
Indicates the amount that the serving size
represents
How to Read the Label

19. 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
How to Read the Label

20. Look-Alike, Sound-Alike
Herbals
– 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

21. Common
Interactions
with Herbals

22. Medicines that Interact with
Dietary Supplements
– Birth Control Pills
– Some herbals may speed up how quickly birth control pills washed out from
the body
– This increases the chance of pregnancy
– For example, St. John’s wort
– 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%20Care%20Professionals/072016/
Common%20Drug%20Nutrient%20Depletions%20and%20Interactions.ashx

23. 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

24. Medicines that Interact with
Dietary Supplements
– Some dietary supplements may block how platelets work.
– If bleeding occurs, platelets with impaired function can’t stop the
bleeding.
– 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

25. Commonly
Used
Herbals

26. 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

27. 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

28. 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

29. 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

30. 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

31. 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
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm246744.htm

32. Dietary Supplements
To Avoid
– 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/ForConsumers/ConsumerUpdates/ucm246744.htm

33. 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

34. – 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’sLetter 2008;24(10):241076.
– How to read a vitamin label (front). Nature Made. Available at:
http://www.naturemade.com/~/media/Images/NatureMade/PDF/Health%20Care%20Professionals/HCP%20Updates%20042315/PID5231
%20How%20to%20Read%20a%20Vitamin%20Label%20Insert_Front_FNL.ashx. Accessed October 1, 2016.
– How to read a vitamin label (back). Nature Made. Available at:
http://www.naturemade.com/~/media/Images/NatureMade/PDF/Health%20Care%20Professionals/HCP%20Updates%20042315/PID5231
%20How%20to%20Read%20a%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. 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.
– 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, 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.
References

35. Thank you ..
Ahmed Ibrahim Nouri, PharmD, MSc.