Card Set Information
otic, dyspepsia, patient counseling, N/V, respiratory.....
What % of people read an OTC label when buying?
What % would rather self treat than go to Dr?
What % of people take an OTC at the first sign of a problem?
When a problem is 'minor' what % of people ask a pharmacist about it?
What is the #1 reason why more people don't talk to a pharmacist?
they are "hidden"
40% of OTCs are purchased by what group?
T/F: women access OTCs more than men.
What is the fastest growing population of medication users?
T/F: compared to Rx drugs, there are ten times more OTC drugs.
Name two drug classes that have gone Rx to OTC.
T/F: More than 80 drugs have been switched from Rx to OTC.
Which act did not require any mandate for safety?
Pure Food and Drug Act 1906
Which act required that drugs be safe?
Federal Food, Drug and Cosmetic Act 1938
Which act required that drugs be safe AND effective?
1962 amendment to FFDCA
Which act separated the Rx medications (legend) from the non-legend medications?
Durham-Humphrey Amendment 1951
Do manufacturers or the FDA have the final say on what category a drug belongs?
What did the Drug Efficacy Study Implementation (DESI) do?
reviewed all drugs between 1938-1962
determined effectiveness and safety
What is the ongoin process called that determines safety and effectiveness?
OTC Drug Review
What are the 3 questions that the FDA uses to decided if a drug should be OTC or legend?
Can patient adequately self-diagnose the problem?
Can problem be successfully treated with an OTC?
Is the self-treatment OTC safe and effective for the consumer to use?
What are the four categories of non-prescription products?
T/F: dietary supplements are considered drugs.
T/F: homeopathics are considered drugs.
Who regulates dietary supplements?
DSHEA (dietary supplement health and education act)
Who regulates advertising of non-prescription drugs?
FTC (federal trade commission)
What class of drugs is OTC but requires counseling by a pharmacist?
T/F: OTC drugs are required by FDA to be much more detailed than Rx drugs.
What two things absolutely must be on an OTC label?
What 8 key points have to be on an OTC label?
description of tamper resistant features
exp date and lot #/batch code
directions for use
name/location of manufacturer
active ingredients (purpose, dosage, dosage form, quantity) and inactive ingredients
Are there any exceptions to the labeling requirements for an OTC? If so, what are they?
When product does not have a dosage limit
If product is considered to be stable for at least 3 years or more
In 2006, the FDA proposed new standards for OTC labels. What are they (4)?
purpose of each active ing
more organized layout
What is the most common drug reclassification?
Product line extension (new dose, formulation, combination of ingredients)
T/F: there are no efficacy requirements for dietary supplements.
T/F: there are no safety requirements for dietary supplements
false; must be safe
Why are dietary supplements not considered as drugs?
b/c they are not intended to treat, cure or diagnose a disease or condition
What two things are typically on a dietary supplement label?
Must state the part of the plant used!
Structure/function claim, but not a disease claim
What % of dietary supplements are legitamite?
What is the theory surrounding homeopathic drugs?
that potency increases with dilution
Which subset of non-rx products are exempt from GNP and are not required to have an NDA?
Which drugs could have a high alcohol content?
What is required in the labeling for a homeopathic product?
instructions for safe use
at least one major indication
What are some cosmetic drug products that would require a valid OTC label?
toothpaste w/ fluoride
makeup with sunscreen in it
What are the classes of drug recalls?
class I (worst)
Which recall class are we required to tell patients about?
What is OBRA '90?
law that requires us to offer to counsel on prescriptions dispensed to medicaid patients
What are some causes of med errors?
patients can't see or can't read
inadequate lighting in retail area
uneducated on proper use
handle and store improperly
What level does the average consumer read at?
8th grade level
What 3 things does triage consist of ?
recommend no treatment
recommend self-care (OTC)
T/F: leading questions should be avoided.
What are the open ended questions?
What is quest?
: QUickly and accurately assess the patient
: Establish that patient is an appropriate candidate for self care
: Suggest appropriate treatment strategies
: Talk with patient
What should you do in Qu of quest?
1st open ended question "What can I help you w/ today?"
2nd open ended question "Tell me more about...."
**Use SCHOLAR** here
What is scholar?
: aggravating factors
: remitting factors (what makes it better?)
What part of quest does scholar fit into?
What should you do in "E" of quest?
establish that patient can do self-care
symptoms are too severe
symptoms are result of unidentifiable cause
patient is elderly, prego, or under 2 (not always though)
What should you do in "S" of quest?
: medication, alternative options, non-pharmacologic txt, general care measures
prevent future problems
Advise patient on
: reason for self txt, describe drug/txt, administration of txt, what to expect from txt (side effects, precautions)
What should you do in "T" of quest?
Talk to patient
explain why you chose particular drug
advise patient of when to expect results from txt
discuss what to do if no results
decide if follow up is necessary
What is MTMS?
medication therapy management services
What allows pharmacists codes to bill for cognitive services?
CPT (current procedural terminology)
T/F: OTCs are rarely labeled for <2 yo.
<1 month old
1-12 months old
What is a common rule when dispensing medication to prego women?
use the oldest drug first (b/c there is more research available on effects)
T/F: herbals and homeopathics should be discouraged when counseling prego women.
Which group of people should avoid taking long-acting, maximum strength, multi-ingredient products?
What group believes that health is a matter of luck (fatalism)
What group believes in alternative medicine and herbs?
What group distrusts the american health system?
What group believes in sweat lodges and prayer for healing/cure?
What type of disorders account for 1.2% of ambulatory care visits per year?
T/F: otic OTCs can be given to children <12 yo.
Why do children often get more ear infections than adults?
b/c their eustacian tubes are more flat whereas adults slope upward
T/F: if a person has tubes in their ears they can use OTC products.
What are some of the exclusions to self-treatment w/ ear OTCs?
sign of infection (pus, fever)
pain associated w/ ear discharge
bleeding or signs of trauma
ruptured tympanic membrane
ear sx in the past 6 weeks
incapable of following instructions
hypersensitivity to product
What is the only FDA approved OTC cerumen softening agent?
carbamide peroxide 6.5% in anhydrous glycerin
What are the 3 components of carbamide peroxide 6.5% wax softener and what does each one do?
: breaks down and loosens earwax
: effervescence breaks down earwax and acts as an antimicrobial
: softens earwax
What are the 2 brands of OTCs that contain carbamide peroxide 6.5% for softening earwax?
Auro Ear drops
: CP 6.5% w/ anhydrous glycerin
Debrox Earwax Removal Aid Kit
: CP 6.5% w/ glycerin; comes with a syringe
What are the instructions and dosing for carbamide peroxide 6.5%?
place 5-10 drops into ear canal and leave in ear for 15 min; flush with bulb/syringe
bid for up to 4 days
T/F: you can run a bottle of eardrops under warm water to warm it up.
Which direction do you pull the ear of child <3 yo?
back and down
Which direction do you pull the ear of an adult?
back and up
What are some alternative agents for softening earwax that are not recommended for self-care?
dilute hydrogen peroxide
T/F: water clogged ears are NOT swimmer's ear or external otitis.
What are the S&S of water clogged ears?
feeling of fullness or wetness
tissue maceration (itching, pain, inflammation, infection)
T/F: you can use a blowdryer to help dry out a wet ear.
true; on low setting
What is the only FDA approved OTC ear drying agent?
isopropyl alcohol 95% in 5% anhydrous glycerin
What is a drying agent that we can compound if we have the correct ingredients, but is not for sale?
50:50 mix of 5% acetic acid with 95% isopropyl alcohol
has bactericidal and antifungal properties
What is the dosing/instructions for isopropyl alcohol + anhydrous glycerin drying agent?
Place 5-10 drops into ear canal and keep in ear 1-2 minutes
What are the contraindications for using iso alcohol+anhydrous glycerin drying agent?
ruptured ear drum or tubes
What are the 2 ingredients in a drying agent and what do they do?
: acts as drying agent and disinfectant
: solvent and emollient to reduce moisture without overdrying the EAC (external auditory canal)
What are the 2 brands of OTCs that contain isopropyl alcohol and anhydrous glycerin for drying ears?
Swim Ear Drops
(both contain same thing)
What are the 3 most common derm disorders of the ear?
What is contact dermatitis?
an alleric reaction or an irritant
drugs (topical neomycin)
nickel in earrings
rubber or plastic
What are the S&S of contact dermatitis?
formation of vesicles
What are the non-pcol and pcol txts for contact derm on the ear?
: minimize exposure to irritant
What is a common astringent used to treat contact dermatitis on the ear?
Burrow's solution (1:40 aluminum acetate in water)
some antibacterial properties
What is the MOA of Burrow's solution?
precipitates proteins and dries the affected area by decreasing secretory function of the skin glands
What are the instructions for Burrow's solution?
apply wet compress of solution several times per day for 4 days
What are the 2 CHRONIC derm disorders of the ear?
Between psoriasis and seborrhea, which one can usually be treated with OTCs and which one requires further intervention?
psoriasis=inflammatory, needs derm txt
_____ is characterized by itching (pruritis), flaking of the skin, and skin fissures?
_______ is characterized by thickening, erythematous, silvery scaly lesions, mostly appears at pressure points (knee, elbow), and if on the scalp, can move to external ear?
What are the pcol txts for seborrhea or psoriasis of the ear?
What is the prevalence of heartburn in the US?
Where is stomach acid formed?
The secretion of stomach acid is stimulated by what 3 substances?
What two things help to protect the stomach from its own acid?
2. nitric oxide
stimulate secretion of bicarbonate and mucous
inhibit secretion of acid
What are the 2 damaging forces in the stomach and what are the 5 protecting factors?
: pepsin, acid
: surface mucous, bicarbonate, mucosal blood flow, epithelial regeneration, prostaglandins
What features does a person with a gastric ulcer present with?
pain in the day
food may increase pain
antacids help pain
What features does a person with a duodenal ulcer present with?
pain at night
pain 1-3 hours after meal
food or antacids can relieve pain
What are the 2 ways that NSAIDS can cause an ulcer?
systemic inhibition of prostaglandin synthesis
How does H. pylori cause ulcers?
direct mucosal damage
alters inflammatory response
increases gastric acid secretion
What are some non-pcol txts for ulcers?
What is the most common upper GI disorder in the western world?
What are some medications that can contribute to GERD?
calcium channel blockers
What are common S&S of GERD?
burning chest pain (heartburn)
regurgitation (sour taste in mouth)
laryngitis, asthma, pulmonary aspiration
What are lifestyle modifications for GERD?
eat smaller meals
elevate head of bed
don't eat 3 hours before bedtime
avoid tight clothes
avoid caffeine, alcohol, citrus or tomato drinks
avoid causative foods
avoid lifting or straining
What is the best remedy for occasional heartburn?
What two products protect ulcerated tissue in the GI tract?
bismuth compounds (Pepto bismol)
What two products increase GI motility?
What are the 5 therapeutic choices for GERD?
What is the MOA of antacids?
they neutralize stomach acid
What is the MOA of H2 antagonists?
they reduce acid secretions
block histamine at the receptors of parietal cells
reduce hydrogen ion production, which reduces HCl
What are some common H2 antagonist?
famotidine (Pepcid AC)
What hobby may decrease the effectiveness of H2 blockers?
Which H2 blocker has the most side effects?
Which drugs should be taken one hour before or after antacids?
Which therapeutic choice for GERD can last up to 24 hours?
What is the MOA for PPIs?
irreversibly bind to H/K ATPase enzyme to prevent the movement of hydrogen ions from the parietal cells into the stomach
What are some common PPIs?
T/F: PPIs can be given with antacids.
Which GERD drug class must be taken 30 min before meal?
Which drug can cause a black tongue or stool?
BSS (bismuth sub salicylate)
What drug is indicated for nausea, diarrhea, heartburn, and upset stomach?
BSS (bismuth sub salicylate)
Which antacids usually have a constipating effect?
---phosphate, hydroxide, carbonate
Which antacid commonly causes a laxative effect?
What is an example of a common magnesium antacid?
MOM (milk of mag)
What is an example of a common aluminum antacid?
aluminum carbonate (Basaljel)
What is an example of a common combination antacid that has both laxative and constipating effects counteracting each other?
T/F: calcium carbonate (Tums) can cause constipation, gas and belching
Excessive use of this antacid could cause kidney stones or hyperacidity rebound?
Tums (calcium carbonate)
Which antacid is highly soluble, fast acting, short duration, but may cause metabolic alkalosis?
sodium bicarb (alka seltzer)
Patients with CHF or hypertension should use which antacid products?
What conditions might prohibit the use of antacids?
How long after taking an antacid can a patient take his/her other regular medications?
1-2 hours after
T/F: antacids can dissolve enteric-coated medications.
What are some exclusions for self-treating heartburn?
younger than 12 for antacids/H2
younger than 18 for PPIs
difficulty swallowing or breathing
heartburn at night
longer than 3 months
unexplained weight loss
What are some herbal products for heartburn/dyspepsia?
What are some of the exclusions for self-treating poisoning?
suspected child abuse
a child <6 months old
What is vomiting controlled by in the brain?
the vomiting center
What are some treatments for nausea?
bismuth salts (Pepto Bismol)
: cytoprotective, enhances secretion of mucus and bicarb, inhibit pepsin
phosphorylated carbohydrate solutions
: fructose, glucose and phosphoric acid
Which antiemetic is not recommended for use in children?
What are the 2 brands of antiemetic liquids?
What are 3 non pcol agents for N/V?
ginger ale or ginger root
T/F: antihistamines can be used to treat N/V.
What is AD for meclizine?
25-50mg 1 hour before travel
NTE 50 mg
What is AD for cyclizine?
50mg 30 minutes before travel
50mg Q4-6 hours
What is the CD for cyclizine?
25mg Q6-8 hours
NTE 75 mg
What is the AD for diphenhydramine for N/V?
25-50mg Q4 hours
What is the CD for diphenhydramine for N/V?
12.5-25mg Q4 hours
for a child 2-6 yo
: 6.25mg Q4 hours
What is the AD for dimenhydrinate?
50-100mg Q4-6 hours
What is the CD for dimenhydrinate?
25-50mg Q6-8 hours
for a child 2-6 yo
: 12.5-25mg Q6-8 hours
Which antiemetic can decrease a mother's milk supply?
What are some treatments for prego women with N/V?
: 12.5mg TID or QID - category A
: 10-25mg TID or QID- category A water-soluble B complex
: reserved for severe N/V- category B
What 2 drugs are used to treat N/V associated with chemo?
What are signs of dehydration in children?
sunken or dry eyes
fast heart beat
decreased skin turgor
Dilation of this will result in internal hemorrhoids?
superior hemorrhoidal plexus
Dilation of this will result in external hemorrhoids?
Which hemorrhoids are generally asymptomatic?
internal hemorrhoids (of the superior hemorrhoidal plexus)
What are the causes of hemorrhoids?
What are the S&S of hemorrhoids?
: with external hem, a steady aching discomfort
: with internal hem, occurs intermittently with BM
: with straining
: warm to intense heat
: due to inflammation
: acute onset of constant pain
What is a local anesthetic used for hemorrhoidal pain, itching or burning?
What is a vasoconstrictor used for hemorrhoidal itching, shrinkage or swelling?
What is a protectant for treating hemorrhoids and relieves pain, itching, irritation associated w/ internal hemorrhoids?
What is an astringent used to temporarily relieve hemorrhoid symptoms and rid itching?
What is a keratolytic for hemorrhoids?
resorcinol-not used anymore
What is an analgesic/anesthetic/antipyretic for hemorrhoid relief?
What is a corticosteroid for treating hemorrhoids?
What are the only 2 herbal products that have support for safety and efficacy for treating hemorrhoids?
What are some non pcol treatments for hemorrhoids?
avoid lifting heavy objects
avoid NSAIDs and aspirin
do not ignore urge
What are the best choices for treating itching/burning with hemorrhoids?