4/3/2014. Understand regulatory and quality issues with the use of natural and herbal products.

Transcription

1 Danielle Ahlstrom, Pharm.D. Elaine Nguyen, Pharm.D., MPH Boise VA Medical Center PGY-1 Pharmacy Residents Understand regulatory and quality issues with the use of natural and herbal products. Be familiar with commonly used natural and herbal products and the evidence (or lack of) behind their use. Recognize available and reliable resources on natural and herbal products. 1

2 Definition Healing approaches not included in conventional/traditional medicinal curricula of the U.S. and Britain What makes it complementary? These healing approaches are used in conjunction with conventional/traditional medicine Merriam-Webster: alternative medicine. Available at: (Accessed 03/22/14). Examples Natural/herbal products Acupuncture Traditional Chinese medicine Massage Spinal manipulation (chiropractors) Yoga Hypnotherapy NIH: National Center for Complementary and Alternative Medicine (NCCAM). Available at: (Accessed 03/22/14). Complementary medicine use 38% of U.S. adults An increase from years prior 12%of U.S. children Complementary medicine spending $33.9 billion spent in 2007 Barnes PM, Bloom B, Nahin R.CDC National Health Statistics Report #12. Complementary and Alternative Medicine Use Among Adults and Children: United States, 2007.December 10, Nahin, RL, Barnes PM, Stussman BJ, and Bloom B.Costs of Complementary and Alternative Medicine (CAM) and Frequency of Visits to CAM Practitioners: United States, 2007.National health statistics reports; no 18. Hyattsville, MD: National Center for Health Statistics

3 Common Reasons for Use Possible Issues Examples of Common Products Resources for Information and Education Points Common Reasons for Use Possible Issues Examples of Common Products Resources for Information and Education Points 3

4 Herbal therapy is thousands of years old Records of herbal medicine date back over 5,000 years ago Estimates have found about 25% of drugs prescribed are derived from plants Digoxin: foxglove Salicylic acid (aspirin): willow bark Morphine: poppy Wachtel-Galor S, Benzie IFF. Herbal Medicine: An Introduction to Its History, Usage, Regulation, Current Trends, and Research Needs. In: Benzie IFF, Wachtel-Galor S, editors. Herbal Medicine: Biomolecular and Clinical Aspects. 2nd edition. Boca Raton (FL): CRC Press; Chapter 1. Available from: Rates SM. Plants as source of drugs. Toxicon. 2001;39(5): RishtonGM. Natural products as a robust source of new drugs and drug leads: past successes and present day issues. Am J Cardiol. 2008;101(10A):43D-49D. Swerdlow JL. Modern Science Embraces Medicinal Plants. Nature s Medicine: Plants that Heal. Washington, DC: National Geographic Society; pp SahuCR, NayakRK, Dhal, NK. Traditional Herbal Remedies for Various Diseases Used by Tribals of BoudhDistrict, Odisha, India for Sustainable Development. International Journal of Herbal Medicine; 2013;1(3):1-20. Believed to be more natural, therefore, less toxic May correspond to patients beliefs Image: Common Reasons for Use Possible Issues Examples of Common Products Resources for Information and Education Points 4

5 Herbs and natural products are classified as dietary supplements Dietary Supplement Health and Education Act (DSHEA) of 1994 Presumed safe Do not need to be approved by the Food and Drug Administration (FDA) for safety and efficacy Not the case for drugs Manufacturers must comply with Current Good Manufacturing Practices (CGMP) FDA: Dietary Supplements. Available at: (Accessed 03/22/14). Manufacturers are not required to disclose information about safety or efficacy FDA does not analyze dietary supplements before they are on the market It is the manufacturer s responsibility to make sure the ingredient list is accurate FDA can take action against adulterated or misbranded products afterit has been on the market FDA: Dietary Supplements. Available at: (Accessed 03/22/14). Manufacturing error caused Aristolochia fangchi to accidentally replace another herb used for weight loss 43 patients had end-stage renal failure 39 patients had their kidney s removed 18 patients were found to have cancer Image: tolochia_clematitis.htm NortierJL, Martinez MC, Schmeiser HH, et al. Urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi). N EnglJ Med Jun 8;342(23):

6 Can interact with medications or be inappropriate in certain disease states Lack of research data Conventional/traditional medicine is based on evidence-based medicine Use the current, best evidence Well done studies and trials to generate data Many natural/herbal products lack this data Mainly because the data is not required to sell the product Wachtel-Galor S, Benzie IFF. Herbal Medicine: An Introduction to Its History, Usage, Regulation, Current Trends, and Research Needs. In: Benzie IFF, Wachtel-Galor S, editors. Herbal Medicine: Biomolecular and Clinical Aspects. 2nd edition. Boca Raton (FL): CRC Press; Chapter 1. Available from: National Center for Complementary and Alternative Medicine (NCCAM) Performing studies to generate new and sound data about complementary medicine Including natural/herbal products NIH: National Center for Complementary and Alternative Medicine (NCCAM). Available at: (Accessed 03/22/14). The use of natural/herbal products for medicine is thousands of years old NCCAM is working to generate new and sound data about natural/herbal products 6

7 The use of natural/herbal products for medicine is thousands of years old NCCAM is working to generate new and sound data about natural/herbal products Common Reasons for Use Possible Issues Examples of Common Products Resources for Information and Education Points Cardiovascular conditions Diabetes Huntington s disease Parkinson s disease Statin-induced myopathy Migraines Likely safe Usually well-tolerated Safety considerations Upset stomach Loss of appetite Nausea, vomiting Diarrhea Decreased blood pressure Natural Medicines Comprehensive Database [Internet]. Stockton, CA: Therapeutic Research Facility; Accessed March 22,

8 Possibly effective Some CV conditions Huntington s disease Parkinson s disease Migraines Muscular dystrophy Immune system improvement (HIV/AIDS) Insufficient evidence Some CV conditions Diabetes Statin-induced myopathy Fibromyalgia Fatigue Image: vitamins.com/4739 Natural Medicines Comprehensive Database [Internet]. Stockton, CA: Therapeutic Research Facility; Accessed March 22, High triglycerides CV conditions Brain food Inflammatory conditions Vision Image: Likely safe(< 3 grams daily) Usually well-tolerated Safety considerations Belching Bad breath Heartburn Nausea Loose stools Rash Nose bleeds Disease-specific considerations Image: 8

9 Effective High triglycerides Likely effective Heart disease Possibly effective High blood pressure Rheumatoid arthritis Attention deficithyperactivity disorder Atherosclerosis Age-related macular degeneration Sleep-related conditions Likely safe Avoid driving 4-5 hours after taking melatonin Usually well-tolerated Safety considerations Headache Depression (short-term) Sleepiness Dizziness Stomach cramps Irritability Disease-specific considerations Natural Medicines Comprehensive Database [Internet]. Stockton, CA: Therapeutic Research Facility; Accessed March 22, Likely effective Sleeping problems in children with autism and intellectual disabilities Sleep disorders in blind people Possibly effective Jet lag Insomnia Possibly ineffective Adjusting sleep schedules (shift work) Image: Natural Medicines Comprehensive Database [Internet]. Stockton, CA: Therapeutic Research Facility; Accessed March 22,

10 Depression Attention deficit-hyperactivity disorder (ADHD) Obsessive compulsive disorder (OCD) Pain Menopausal symptoms Topical conditions Natural Medicines Comprehensive Database [Internet]. Stockton, CA: Therapeutic Research Facility; Accessed March 22, Likely safe up to 8 weeks, possibly 1 year Possibly unsafein large doses Image: /07/top-10-uses-for-st-johns-wort.html Usually well-tolerated Safety considerations Drug interactions Photosensitivity Insomnia Anxiety Psychotic disturbances Gastrointestinal symptoms Sexual dysfunction Withdrawal effects Natural Medicines Comprehensive Database [Internet]. Stockton, CA: Therapeutic Research Facility; Accessed March 22, Likely effective Depression Possibly effective Menopausal symptoms Wound healing Possibly ineffective ADHD Insufficient evidence OCD Premenstrual symptoms Image: Natural Medicines Comprehensive Database [Internet]. Stockton, CA: Therapeutic Research Facility; Accessed March 22,

11 Anxiety Stress Insomnia Possibly unsafe Banned in Canada, Switzerland, and Germany Safety considerations Hepatotoxicity Liver failure Death Use is not recommended Natural Medicines Comprehensive Database [Internet]. Stockton, CA: Therapeutic Research Facility; Accessed March 22, Possibly effective Anxiety Benzodiazepine withdrawal Insufficient evidence Insomnia Image: Kava-Extract-250-mg-120-Capsules/665 Infections (common cold, upper respiratory) Likely safe Usually well-tolerated Safety considerations Gastrointestinal effects Fever Unpleasant taste Sore throat Dry mouth Headache Insomnia Muscle aches 11

12 Possibly effective Common cold Insufficient Evidence Influenza Urinary tract infections Allergies Image: /Photo/_new/ echinacea-hmed-1a.jpg Benign prostatic hypertrophy (BPH) Likely safe Safety considerations Dizziness Headache Dizziness Nausea/vomiting Constipation Diarrhea Image: Standardized-Extract-Saw-Palmetto-Herbal-Supplement- Softgels-160mg-100-count/ Natural Medicines Comprehensive Database [Internet]. Stockton, CA: Therapeutic Research Facility; Accessed March 22, Possibly ineffective BPH Insufficient evidence Prostate infections Chronic pelvic syndrome Prostate cancer Baldness Image: Saw-Palmetto-Herbal-Supplement-Softgels-160mg-100-count/

13 Urinary tract infections (UTIs) Urinary deodorizer (incontinence) Likely safe Usually well-tolerated Safety considerations (large doses, 3-4L/daily) Stomach upset Diarrhea Possibly effective Preventing UTIs Insufficient evidence Urinary odor ImageLhttp:// Cranberry-Supplement-450-Mg-Tablet?skuId= Osteoarthritis (OA) Likely/possibly safe Safety considerations Nausea Heartburn Gas, bloating Constipation Diarrhea Osteoarthritis Likely effective (glucosamine sulfate) Possibly effective (chondroitin sulfate) Insufficient evidence (glucosamine HCl) 13

14 Common Reasons for Use Possible Issues Examples of Common Products Resources for Information and Education Points National Center for Complementary and Alternative Medicine (NCCAM) Herbs at a Glance section Natural Medicines Comprehensive Database Detailed information on safety, efficacy, and interactions Considered the Gold Standard Review of Natural Products NP Appendices (use during pregnancy, grapefruit interactions, etc.) ConsumerLab Tests quality 14

15 US Pharmacopeia Tests quality Voluntarily submitted USP Verified Mark Placed on product if meets requirements Image: USP: Verification Services. Available at: (Accessed 03/22/14). Watch out for false statements Quick fixes, rapid results Cure-all treatments Completely safe No side effects Natural does not always mean safe Products can interact with medications or be inappropriate in certain disease states FDA: Dietary Supplements: What you Need to Know. Available at: (Accessed 03/22/14). Safety and efficacy for natural/herbal products are not established by the FDA FDA does not analyze natural/herbal products before they are on the market Utilize US Pharmacopeia or ConsumerLabto help distinguish verified products 15

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