3-4 Exam 13: Guest Lecturers

Front 1

1. Describe the general functions and focus of the FDA

Back 1

• Food and Drug Administration (FDA)
o Approves medications
o Provides references
• Healthcare professionals
• Consumers
• FDA focuses on:
o Safety
o Efficacy
• Human and animal trials
o Risks vs. benefits
o Public need (social pressures)

Front 2

2. Describe the general drug approval pathway from the drug discovery phase to the post-approval trials.

Back 2

• Discovery
• Preclinical Research Stage (in vitro and animal tests)
• Clinical
o Phase I - $5-10M
o Phase II - $10-20M
o Phase III - $30-50M
• NDA and Reviewing Applications
• Post Approval Study

Front 3

3. Compare and contrast the general concepts of safety and regulation governing prescription medications and natural products (herbals/supplements). Hint: Are either of these options (Rx or natural) 100% safe?

Back 3

• Rx must be FDA approved
• Supplements…
o “These statements have not been evaluated by the FDA.
o This product is not intended to diagnose, treat, cure or prevent any disease!!!!”
o Anyone can market a supplement/herbal natural product but FDA will not endorse it
• The FDA website features natural products:

Front 4

4. Apply the general ideas of ethics to the drug approval process. Hints: Are any studies 100% safe? Is informed consent an important consideration prior to enrolling study participants?

Back 4

• NO study is 100% safe, must sign waiver which means pt should be competent.
• Professionals have to be educated on:
o Study limitations
o Post-approval use compared to use in trials
o Inherent risk of drug therapy

Front 5

5. Apply your ongoing curiosity to patient requests for information in natural products (herbals/supplements). Hint: What other information is necessary? Patient Presentation; Past medical history; Current medication list and diagnoses; etc.
• Is this stuff safe?

Back 5

o Look it up
o Tell the patient the information available
o Communicate the risks
o Let the patient decide

Front 6

1. Describe global and national use of natural products.

Back 6

• World Health Organization WHO-identified that medicinal plants are primary source of medicine for over 70% of the world population.
• 20-25% of pharmaceutical products marketed in the United States are Natural Products or directly derived from Natural Products
• Information on Natural Products is bewilderingly volumous including: marketing information, published articles, research results and authoritative monographs and reviews

Front 7

2. Explain the role of the National Center for Complementary and Alternative Medicine (NIH) and German Commission E.

Back 7

• German Commission E.
o Evaluates herbal medicines and provides monographs for their uses.
o Originated in 1978-Evaluates traditional uses, chemical, pharmacological, toxicological, epidemiological, clinical data and individual physician case reports
o Monographs are reviewed by commission members, outside scientists, University specialists
o Over 300 Monographs on uses, side-effects and drug interactions of herbal substances
• National Center for Complementary and Alternative Medicine (NIH)
o NCCAM-Administered under the National Institutes of Health-1992
o Funded at over $120 million annually
o Mission: Sponsor research on CAM-disseminate authorative information to the public
o Sponsor training centers and practitioners- www.nccam.nih.gov

Front 8

3. Identify reasons that patients seek complementary/alternative medicine (CAM) therapies.

Back 8

• 25.9%-Avoid side effects of conventional therapy
• 25% Failure of conventional therapy
• 24% Friend/Family recommended
• 15% Preferred to self treat
• 10% informed about therapy in News/Media

Front 9

5. Identify common natural product interactions with medications.

Back 9

1. St John’s Wort: Multiple drug interactions-induces cytochrome P450-3A4- Theophylline, HIV drugs, Cyclosporin, Tacrolimus,Warfarin, Nifedipine, Diltiazem, many others
2. Vitamin C: increases the absorption of Iron-maybe good or bad.
3. Green Tea- may interfere with boronic acid type proteasome inhibitors such as Bortezomib (Valecade). Caution use with anticancer therapy
4. Echinacea: use few weeks at a time- hepatotoxic –alcohol
5. Fish Oil: may change INR-Warfarin
6. Hawthorn: increases Digoxin effect enhances hypotensive agents antiarrythemics
7. Kava: Taken off market- Canada; concerns of hepatoxicity - FDA safety advisory
8. Soy Isoflavones: Tamoxifen - estrogen receptor competition-caution in history of breast cancer.
9. Creatinine: decreases renal function-diuretics-dehydration concern-renal failure
10. Garlic: induces Cytochrome P450-3A4 Cyclosporin, Saquinavir, Warfarin may need adjustment
11. Gensing: Warfarin, increases Insulin demand
12. Ginger: additive hypotensive effectreduces Insulin demand (caution: gallstone, warfarin)
13. Gingko: potentiates MAO-I, increase PTT (Warfarin) Aspirin, clopidogrel ,dipyridamole,Vit E., Garlic
14. Glucosamine: increase Insulin demand or Insulin resistance (avoid in pt w/ shell fish allergy)

Front 10

Explain the naturopathic physician formulary change that went into effect in Oregon in 2010.

Back 10

• Oregon SB 327-effective January 1, 2010. ORS 685.125
• Changes from inclusionary to exclusionary system
• Exceptions include some antineoplastics, anti-psychotic medications.
• Current IV regulations remain unchanged

Front 11

Identify the principles of naturopathic medicine.

Back 11

• The healing power of nature
• First do no harm
• Identify and treat the cause
• Treat the whole person
• The physician as teacher
• Prevention

Front 12

Describe the education and training of naturopathic physicians in Oregon.

Back 12

• 4 year post baccalaureate professional education
• NPLEx Part 1 and Part 2
• Residency-some states mandatory, others optional
• Annual renewal through state (Board)
o CEU’s 35-50 hours a year (Oregon)
o Clinical Sciences
o Naturopathic Modalities
• Clinical Nutrition
• Homeopathy
• Botanical Medicine
• Mind-Body Medicine
• Physical Medicine
• Minor Surgery
• Obstetrics/Midwifery
o Naturopathic Philosophy
o Medical Ethics
o Clinical Competencies
o Clinical Rotations

Front 13

1. Define integrative medicine and discuss patient-care philosophy

Back 13

• “…the practice of medicine that reaffirms the importance of the relationship between practitioner & patient, focuses on the whole person, is informed by evidence & makes use of all appropriate therapeutic approaches, healthcare professionals & disciplines to achieve optimal health & healing”
• Pt centered

Front 14

2. Explain relevance of integrative medicine to pharmacy practice

Back 14

• Pharmacists will be the health care professionals responsible for providing patient care that ensures optimal medication therapy outcomes.”
o Nutrition, dietary supplements, herbs too

Front 15

3. Identify examples of micronutrients used in the therapy of various health conditions

Back 15

• folate deficiency = Anemia
• iodine = brain damage, thyroid, fetal development
• vit a = night blindness, immune system dysfunction, birth defects
• iron = anemia

Front 16

4. Describe how nutritional/dietary interventions may influence various health conditions

Back 16

• Malnutrition
o Rapid weight loss/dieting
o Obesity
• Malabsorption = any GI condition can lead to Malaborption
o Gastric bypass surgery
• Calcium, iron, B12, folate, thiamine, fat soluble nutrients (A,D,E,K)
o Short bowel syndrome
• Calcium, magnesium, zinc, fat soluble nutrients (A,D,E,K)
o Inflammatory bowel disease
• Iron, B12, folate, magnesium, potassium, zinc, vitamin D
• GI losses
o Vomiting
• Potassium (water and electrolytes)
o Diarrhea
• Magnesium, Potassium (water and electrolytes)
• Substance-use disorder
o Tobacco
• Ascorbic acid, vitamin E, vitamin B12, folate
o Alcohol
• Thiamine (Wernicke-Korsakoff syndrome), riboflavin (B2), pyridoxine (B6), vitamin A, ascorbic acid