Case Study #3
Since the passage of the Food, Drug and Cosmetic Act of 1931, Americans expect that all prescription/OTC drugs have passed rigid standards of safety prior to being put on the market. They also believe the effectiveness has been tested and provide therapeutic benefits claimed by the manufacturer.
Herbal products and specialty supplements are regulated by less rigorous law, the Dietary Supplement Health and Education Act/DSHEA of 1994. This law exempts dietary supplements from the Food, Drug and Cosmetic Act, the law that regulates prescription drugs.
For this assignment:
Read the information on pages 78-79 on DSHEA
List the strengths of this law
The book lists the flaws of the DSHEA regulations. List these flaws
How can these flaws affect you, your patient or the population at large?
Then explain how these regulations differ from those applied to prescription drugs?
Use this information to complete the following case studies:
Mr. K., a 42-year old teacher has been taking gingko biloba for 5 years since he was diagnosed with a memory disorder, yet he feels his condition is worsening. He has also been taking Echinacea regularly, yet he now has the flu and probably pneumonia. He is angry and feels that the advertisements in nutrition magazines, on television, and on the bottles of his herbals have misled him into buying useless products. He is seeking advice from you regarding the value of alternative therapies. He also wants to know why the FDA does not do something about this
a) What will you explain to Mr. K. about the value of alternative therapies including those he is on?
b) What can you tell him about advertisements for natural therapies and the FDA’s role?
c) Research on alternative therapies has failed to demonstrate positive benefits that have been reported.
What are some of the reasons why scientific research has had difficulty demonstrating the effects of botanicals?
Does this mean these therapies are ineffective?
2. Mrs. R. comes to your clinic with new symptoms, including agitation, headache, and dizziness. You note on assessment that she is sweating profusely. She has been treated with depression with Prozac, a selective serotonin reuptake inhibitor (SSRI). She tells you during the patient history that she has been taking St. John’s wort with her Prozac. She asks if the prescription can be changed to something that works better.
a) What is the likely cause of Mrs. R’s symptoms? Explain why.
b) In your education to Mrs. R. about interactions between drugs-herbs, what other antidepressants may also interact unfavorably with St. John’s wort?
