OTC Exam 1

  1. Limitations of OTC package labeling?
    • Co-morbidity (other medical conditions)
    • Polypharmacy (other drugs)
  2. Monograph requirements?
    • Description
    • Ingredients
    • Labeling
  3. OTC Category I
    Generally recognized as safe and effective for the claimed indication
  4. OTC Category II
    Not generally recognized as safe and effective for the claimed indication
  5. OTC Category III
    Insufficient data available to permit final classification
  6. Under the new rules, oral OTC meds must state the exact amount of particular ingredients such as:
    • Calcium
    • Potassium
    • Magnesium
    • Sodium
  7. Mechanisms for reclassification (Rx to OTC)
    • Full NDA
    • "Switch regulation"
    • A supplement to NDA
    • The OTC advisory panels recommend changing many Rx ingredients to OTC (Petition from manufactures)
  8. Define pharmaceutical care (Patient Care)
    Designing, implementing and monitoring a therapeutic plan, in cooperation with the patient and other health care professionals that will produce specific therapeutic outcomes.
  9. Skills necessary to care for patients with self-care needs:
    • Communication
    • Effective questioning
    • Effective listening
    • Nonverbal communication
    • Techniques for special populations
  10. Alternatives for self-medication
    • OTC
    • Nutritional Supplements
    • Natural Products and homeopathic remedies
  11. Reasons why patients prefer OTC
    • Avoid contact with doctors
    • Fear of what they may be told
    • Convenience
    • Cost
  12. Define Self-care
    The independent act of preventing, diagnosing and treating one's own illness without seeking professional advice
  13. What are the two types of self-care?
    • Preventing self-care
    • Sickness self-care
  14. What is the first level of self-care?
    Self medication
  15. Define dietary supplements
    Products intended to supplement the diet and bear contain one of more dietary ingredients such as vitamin, mineral, herb and amino acid.
  16. Top selling supplements
    • Garlic
    • Echinacea
    • Saw Palmetto
    • Ginkgo Biloba
  17. Natural products with the highest interactions recorded:
    • St John's wart
    • Ginkgo biloba
  18. Factors that drive trust on self-medication includes:
    • Increasing cost of health care
    • Increasing aging population
    • Gender difference
    • Restricted access to prescribers through health management organizations
    • High number of uninsured and under-insured people
  19. What kind of questions should be avoid in patient care?
    Leading and multipart questions
  20. Two factors determining teratogenic effects?
    • Stage of pregnancy
    • Ability of medication to pass from placenta
  21. Important counseling points:
    • 1. Selection of fright product
    • 2. Rx-OTC drug interaction
    • 3. Side effects / ADRs
    • 4. Directions / instructions for use
    • 5. Cost
  22. Steps in self-care encounter:
    • QuEST
    • Quick assess the patient
    • Establish if pt is self-care candidate
    • Suggest appropriate strategies
    • Talk about the strategies
  23. Therapeutic significant drug interactions with Tylenol
    • Ethanol
    • Coumadin
  24. Recommended adult dosage of Tylenol
    • 325-650 Q4h
    • 325-500 Q6h
    • 650-1000 Q8h
    • Not to exceed 4g in 24hs

    Same as aspirin dose for mild-moderate pain
  25. Ibuprofen OTC analgesic dose
    • 200-400mg Q4-6h
    • Not to exceed 1200mg in 24hs
    • Do NOT take for pain >10days or fever>3days, unless directed by physician
  26. Ibuprofen Therapeutic Considerations
    • GI tract (dyspepsia, heartburn, nausea, anorexia and epigastric pain)
    • Platelet aggregation
    • Renal blood flow
    • Weight gain
    • Cross-reactivity with aspirin
    • Pregnancy (Contraindicated during 3rd trimester of pregnancy)
    • Chicken Pox
  27. Aleve
    • Naproxen 220mg
    • Dose 12-65yo: 1tab PO Q8-12h
    • Person >65yo should not take more than 2tabs/day, or 1tab Q12h
    • Take with food, water or milk
  28. Main drug interactions with ASA
    • Valproic Acid
    • Sulfonylureas
    • Probenecid
    • Ethanol
    • Warfarin
Card Set
OTC Exam 1
OTC Exam 1 material