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What is an OTC?
safe and effective for consumer to use on their own
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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
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What regulates OTCs?
FDA - regulates prescription advertisement and OTC themselves (safety and efficacy)
Federal Trade Commission - regulates OTC advertisement
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What is the NDMA?
Non-Prescription Drug Manufacturers Association (NDMA) - association of OTC factors
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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
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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***
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Alcohol Content & Package Size
Alcohol - used to help medication into the system; "elixir" usually means it contains alcohol
OTCs limited to certain package sizes
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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!!!
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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)
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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
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What patient data should you collect when doing a patient assessment or consultation?
Chronic medical conditions = prescriptions, drugs, diseases, etc.
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Name some examples of high risk patients?
pediatrics, diabetics, pregnant women, cardiovascular diseased patients, and geriatric (elderly)
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Name all of the respiratory diseases discussed in class
common cold, allergic rhinitis (season and perenial allergies), sinusitis, cough, asthma
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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
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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
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3 types of pollen
- Tree - late March till May
- Grass - May till July
- Ragweed - mid August till frost
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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
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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
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Sedating Anithistamine
- chlorpheniramine (least)
- brompheniramine
- clemastine
- triprolidine
- dexbrompheniramine
- diphenydramine (most)
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Sinusitis (Bacterial)
nasal discharge is lime/fluroescent green/ brown and you should see a doctor
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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
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asthma
don't treat with OTCs
bronchioles are constricted "panting dog syndrom" --> asthma attack = sucking air with a straw
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