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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?
- dietary supplements
- drug cosmetics
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?
- active ingredients
- inactive ingredients
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
- product name
- 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)?
- bigger font
- purpose of each active ing
- layman language
- 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
- dilution instructions
What are some cosmetic drug products that would require a valid OTC label?
- toothpaste w/ fluoride
- antidandruff shampoo
- makeup with sunscreen in it
- antiperspirant deoderant
What are the classes of drug recalls?
- class I (worst)
- class II
- class III
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
- language barrier
- 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?
- Qu: QUickly and accurately assess the patient
- E: Establish that patient is an appropriate candidate for self care
- S: Suggest appropriate treatment strategies
- T: Talk with patient
What should you do in Qu of quest?
- introduce yourself
- 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?
- S: symptoms
- C: characteristics
- H: history
- O: onset
- L: location
- A: aggravating factors
- R: 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
- refer if:
- you're unsure
- 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?
- suggest: 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.
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
- tubes present
- incapable of following instructions
- hypersensitivity to product
- <12 yo
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?
- Urea: breaks down and loosens earwax
- Hydrogen Peroxide: effervescence breaks down earwax and acts as an antimicrobial
- Anhydrous Glycerin: 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?
- mineral oil
- olive oil
- docusate sodium
- dilute hydrogen peroxide
- herbal remedies
- ear candles
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
- hearing loss
- 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?
- isopropyl alcohol: acts as drying agent and disinfectant
- anhydrous glycerin: 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?
- Auro-Dri Drops
- Swim Ear Drops
- (both contain same thing)
What are the 3 most common derm disorders of the ear?
- contact dermatitis
What is contact dermatitis?
- an alleric reaction or an irritant
- drugs (topical neomycin)
- nickel in earrings
- poison ivy
- rubber or plastic
What are the S&S of contact dermatitis?
- maculopapular rash
- formation of vesicles
- pruritis (itch)
What are the non-pcol and pcol txts for contact derm on the ear?
- non: minimize exposure to irritant
- pcol: astringents
What is a common astringent used to treat contact dermatitis on the ear?
- Burrow's solution (1:40 aluminum acetate in water): antipruritic
- 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?
- seborrhea= OTC
- 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?
- anti-seborrheic shampoos
- topical hydrocortisone
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?
- histamine (H2)
What two things help to protect the stomach from its own acid?
- 1. prostaglandins
- 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?
- Damage: pepsin, acid
- Protecting: 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?
- direct irritation
- 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?
- stop smoking
- stop drinking
- alter diet
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
- lose weight
- stop smoking
- 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?
- dicyclomine (Bentyl)
- metoclopramide (Reglan)
What are the 5 therapeutic choices for GERD?
- H2 antagonists
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?
- cimetidine (Tagamet)
- famotidine (Pepcid AC)
- nizantidine (Axid)
- ranitidine (Zantac)
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?
- omeprazole (Prilosec)
- lansoprazole (Prevacid)
- rabeprazole (Aciphex)
- pantoprazole (Protonix)
- esomeprazole (Nexium)
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?
- aluminum salts
- ---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?
- (low salt)
What conditions might prohibit the use of antacids?
- GI obstruction
- renal disease
- fluid imbalances
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
- chest pain
- difficulty swallowing or breathing
- heartburn at night
- longer than 3 months
- unexplained weight loss
What are some herbal products for heartburn/dyspepsia?
- caraway oil
What are some of the exclusions for self-treating poisoning?
- CNS depression
- unknown substance
- older age
- suspected suicide
- suspected child abuse
- substance abuse
- a child <6 months old
What is vomiting controlled by in the brain?
the vomiting center
What are some treatments for nausea?
- antacids(upset stomach)
- H2 antagonists
- 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
- NTE 200mg
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
- NTE 300mg
What is the CD for diphenhydramine for N/V?
- 12.5-25mg Q4 hours
- NTE 150mg
- for a child 2-6 yo: 6.25mg Q4 hours
- NTE 25mg
What is the AD for dimenhydrinate?
- 50-100mg Q4-6 hours
- NTE 400mg
What is the CD for dimenhydrinate?
- 25-50mg Q6-8 hours
- NTE 150mg
- for a child 2-6 yo: 12.5-25mg Q6-8 hours
- NTE 75mg
Which antiemetic can decrease a mother's milk supply?
What are some treatments for prego women with N/V?
- Doxylamine: 12.5mg TID or QID - category A
- Pyridoxine: 10-25mg TID or QID- category A water-soluble B complex
- Antihistamines: 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
- dry mouth
- decreased urine
- fast heart beat
- minimal tears
- decreased skin turgor
- unusual sleepiness
- weight loss
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?
- erect posture
- anal infection
- traveller's diarrhea
- prolonged diarrhea
- prolonged constipation
- rectal cancer
What are the S&S of hemorrhoids?
- pain: with external hem, a steady aching discomfort
- bleeding: with internal hem, occurs intermittently with BM
- prolapse: with straining
- burning: warm to intense heat
- itching: due to inflammation
- thrombosis: 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?
- mineral oil
- zinc oxide
What is an astringent used to temporarily relieve hemorrhoid symptoms and rid itching?
- witch hazel
- zinc oxide
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
- increase exercise
- avoid NSAIDs and aspirin
- sitz baths
- do not ignore urge
What are the best choices for treating itching/burning with hemorrhoids?
- hydrocortisone ointment