OTC Products

  1. What is an OTC?
    safe and effective for consumer to use on their own
  2. What are the two legal law for OTCs?
    Durham-Humphrey Amendments created the two classes of drugs: presciption and OTC

    Kefauver-Harris Amendment states that all drugs have to be effective
  3. What regulates OTCs?
    FDA - regulates prescription advertisement and OTC themselves (safety and efficacy)

    Federal Trade Commission - regulates OTC advertisement
  4. What is the NDMA?
    Non-Prescription Drug Manufacturers Association (NDMA) - association of OTC factors
  5. What are problems with the use of OTCs? (4)
    • 1 - self assessment, sometimes they mis-diagnose themselves
    • 2 - mask the symptoms of serious diseases
    • 3 - drug interaction, adverse reactions with other prescription drugs
    • 4 - improper use - patient will sometimes take too much
  6. Three Active Ingredients Categories
    • Category I - safe and effective; example: simethicone
    • Category II - not safe or not effective or both
    • Category III - safe, but not sure of efficacy; example: guaifenesin

    ***permitted combinations - different maximum active ingredients for different categories***
  7. Alcohol Content & Package Size
    Alcohol - used to help medication into the system; "elixir" usually means it contains alcohol

    OTCs limited to certain package sizes
  8. What are the reasons or problems of prescription drugs switch to being an OTC?
    • Background - FDA's primary concern is safety and self diagnosis
    • Incentives - money and people wanted to self medicate
    • Problems/Roadblocks - can they appropriately self diagnose --> Call your doctor!!!
  9. What is a behind the counter class of drugs?
    Not an OTC and not a prescription. These are drugs that the pharmacists has to get for you, such as Plan B (Category III)
  10. When collecting data about symptoms and analysis for a patient assessment and consultation, what should you ask or look for?
    • 1 - onset = When did the symptoms occur?
    • 2 - duration = How long have you experienced these symptoms?
    • 3 - description = describe the symptoms
    • 4 - previous treatment
  11. What patient data should you collect when doing a patient assessment or consultation?
    Chronic medical conditions = prescriptions, drugs, diseases, etc.
  12. Name some examples of high risk patients?
    pediatrics, diabetics, pregnant women, cardiovascular diseased patients, and geriatric (elderly)
  13. Name all of the respiratory diseases discussed in class
    common cold, allergic rhinitis (season and perenial allergies), sinusitis, cough, asthma
  14. Common Cold
    • Caused by a virus; antibiotics are useless
    • Primary Transmission: inhaling water vapor (sneezing), but Other transmissions include hand to hand contact
    • Progression: sore throat -> nasal symptoms -> cough
    • colds will usually last 7-10 days
    • 2-3 days after expsure do symptoms start; symptoms usually peak 5 days
  15. Allergies Rhinitis
    usually takes 2 years of exposure to the allergen to cause allergic symptoms

    Season allergies - Hay fever; almost always caused by pollen

    Perenial Allergies - all year long due to mold, dust mites, pet hair (dander) Ex. cats secrete protein that becomes airborne for hours
  16. 3 types of pollen
    • Tree - late March till May
    • Grass - May till July
    • Ragweed - mid August till frost
  17. Difference between cold and allergy in dealing with nasal discharge
    Common Cold: mucoprulent (thick and cloudy); occurs especially during days 1-3

    Allergies: watery occurs anytime
  18. Colds vs. Flu
    • Fever: rare / yes, (102 - 104 degrees) last 3-4 days
    • Headache: rare / prominent
    • General aches and pains: slight / usual, often severe
    • Fatigue, weakness: quite mild / can last 2-3 weeks
    • Extreme exhaustion: never / early and prominent
    • Stuffy Nose: common / sometimes
    • Sneezing: usual / sometimes
    • Sore Throat: common / sometimes
    • Cough: mild/moderate / common, can become severe
    • Possible Complications: sinus congestion, sinus infection, earache / bronchitis, pneumonia
  19. Sedating Anithistamine
    • chlorpheniramine (least)
    • brompheniramine
    • clemastine
    • triprolidine
    • dexbrompheniramine
    • diphenydramine (most)
  20. Sinusitis (Bacterial)
    nasal discharge is lime/fluroescent green/ brown and you should see a doctor
  21. cough
    body's natural defense to get all the stuff/secretions/debris/muscous in the lungs

    • Two types: productive and non-productive
    • productive - chunky, crispy cough "coughing up stuff"; usually don't want to suppress unless at night for sleep

    non productive - dry, haky cough --> ok to treat
  22. asthma
    don't treat with OTCs

    bronchioles are constricted "panting dog syndrom" --> asthma attack = sucking air with a straw
Card Set
OTC Products
Over the Counter Products