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