This assignment is designed to explore the premise that “natural” products can be used safely and effectively, and in many cases, work as well as prescribed medications. The U.S. Food and Drug Administration (FDA) regulates all prescription medications based on their claim to treat, manage or cure a disease/medical condition. The FDA regulates dietary supplements differently, although they are often used as curative medications.
The following is an excerpt from the FDA website:
As dental professionals, you will encounter patients who take “natural remedies”. Upon questioning, you are likely to find these patients using the remedies for conditions for which a prescription medication is already available. How will you assess drug interactions and side effects if they are not readily available in a drug “handbook”? How will you incorporate this information into the treatment you are planning for each patient?
You will each be assigned a natural product to review. The following information must be included in your essay review:
I. Product information
• Product name- common name(s), scientific name, medical name
• Pharmacologic classification
• Product available forms (Ex: tea, powder, tablet, tincture, suspension, cream, extract)
• Product labeled use
• Product off-label use, if indicated
• Product image- as it appears in nature
• Product image- as packaged for consumer use
• Product source- include country/countries and environmental region
Dietary Supplement Products & Ingredients.
The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.
Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as “reduces pain” or “treats heart disease.” Claims like these can only legitimately be made for drugs, not dietary supplements.
Dietary supplements include such ingredients as vitamins, minerals, herbs, amino acids, and enzymes. Dietary supplements are marketed in forms such as tablets, capsules, softgels, gelcaps, powders, and liquids.
• Manufacturing and distribution process- include any information on clinical trials and independent research
• Significant adverse effects, drug interactions and potential contraindications
• Oral manifestations
II. Impact on the dental hygienist
• Product comparison with a known prescription medication that treats a similar condition
• What makes this product attractive to the consumer?
• What means does the consumer have to assess this product and on what might they base a comparison with a prescribed drug?
• As an health educator, how extensive should your knowledge be about natural products in general and how would you verify your sources?
• What should be your comfort level in patient medical review of this type of product and discussing possible associated risks?
• How would you incorporate the interactions of this product in to your treatment plan?
