OTC Products (Pharm tech lesson 13)

OTC Products

Safe for common consumer to select and use on their own without prescription or physician guidance, considered self medicating, pharmacists only can offer consult

Rx to OTC Switch

Safe based on market research and data collected by drug manufacturer

Low abuse potential

Benefits greater than potential risks as OTC

Easy for common consumer to self diagnose, treat, and administer drug for illness

Can always switch back if deemed unsafe

Durham-Humphry Amendment

Any highly addictive or habit forming drug OR drugs that could impose harm must be prescribed under physician and would be labeled Rx

Issues and warnings with OTC Products

May affect prescription medications

Consumers must read and follow the precautions and warnings of OTC products

Consumer should be encouraged to consult with pharmacist when taking OTC drugs, especially when taking other drugs

Analgesics

OTC category used for treating mild to moderate pain and inflammation

Usually first approach for treating mild to moderate pain

Used for headaches, back pain, muscle sores, and pain form injury or post operation

MANY ARE ALSO ANTIPYRETICS; care must be taken if both types are used at once

Made in child and infant forms

Includes acetaminophen, salicylate, and nonsteroidal anti-inflammatory drugs (NSAIDs)

Antipyretic

OTC category used for reducing or eliminating fevers, but does not treat the root cause, can be used to reduce swelling, especially in joints

Fevers usually caused by infections so prescribed antibiotics may be necessary

Fever spikes above 104 or fevers lasting more than a few days, especially in children or immunocompromised should be checked by physician

Acetaminophen

Most common analgesic, extended use of over 4gm a day can cause liver damage and death

Also antipyretic: can be used in children under 6 months, but dose should be weight based at about 10-15 mg/kg/dose every 4-6 hours as needed

Risk of liver damage increased by drinking alcohol and taking acetaminophen

Primary ingredient in cold and flu medications

Salicylate

Aspirin, has anti inflammatory and antiplatelet effects, products with salicylate can also contain acetaminophen and/or caffeine

Increases risk of peptic ulcers, tinnitus, hearing impairment, increased bleeding and renal impairment

In pediatrics, it increases risk for Reye’s Syndrome

Drug to drug interaction with anti coagulants: Excessive bleeding, ulceration, gastrointestinal irritation, perforation

Nonsteroidal anti-inflammatory drugs (NSAIDs)

Carry warnings of gastrointestinal problems, dosing should be adjusted for those with renal problems

Treat mild to moderate pain associated with migraines, osteoarthritis, and rheumatoid arthritis

Safe for children but not recommended for infants under 6 months

Should not be taken for extended time period

Can lead to gastrointestinal bleeding and ulcers

Magnesium salicylate carries warning for patients with renal impairment and should not be taken with alcohol

Respiratory agent

Used for stuffy nose, cough, sore throat, ect often due to seasonal allergies, cold or flu

Many are safe for children and older adults, but have warnings for those with heart disease or use blood pressure medications

Categories include: Antihistamines, antitussives, decongestants and expectorants

Ibuprofen

NSAID and antipyretic, not recommended for children under 2, doses should be recommended by physician since it is not recommended for young children

Aspirin and Naproxen

Can be used as antipyretic for adults, but never for those under 19 years of age due to risk of Reye’s Syndrome, Naproxen has not been proven safe for children

Antihistamines

Help control allergy symptoms and mild allergic responses, blocks histamine and leukotriene receptors

Side effects include drowsiness, dry mouth, blurred vision, dizziness, headaches, and constipation

Antitussives

Calm unproductive coughs, often used in combination with expectorants or decongestants

Safe four children over 4, dose and safety should be decided by physician for children under 4

Often Dextromethorphan for OTC

Decongestants

Relieve stuffy nose and chest congestion, often combined with analgesics

Narrows swollen nasal passages to allow sinus drainage and mucus buildup can be expelled through the nose

OTC includes pseudoephedrine, phenylephrine

Safe four children over 4, dose and safety should be decided by physician for children under 4

MOAIs and tricyclic antidepressants increase effects, Herbal medications Ephedra and Yohimbe may produce CNS stimulation with combined use

Main ingredients are ephedrine, naphazoline, oxymetazoline, phenylephrine

Should not exceed 3 to 5 days use, nasal sprays not recommended for children under 12

Expectorants

Help expel mucus associated with chest congestion/stuffy nose, makes breathing easier, used for nonproductive coughs where buildup pf phlegm and mucus should be expelled from lungs or for productive coughs

Guaifenesin is OTC, but should not be used for chronic coughs, DM is with antitussive dextromethorphan and clears congestion and eases cough, AC type is class V narcotic and is prescription in most states

Antacids

Neutralize stomach acid, alleviate heartburn symptoms but does not address cause, usually calcium carbonate, should not be given to children under 2, limited for children under 2

Can be magnesium carbonate, magnesium hydroxide, aluminum hydroxide, sodium bicarbonate, or citric acid but these should not be used for children

H2 Receptor Antagonists

Block stomach acid, reduce its buildup, treat heartburn and sour stomach, treat stomach ulcers and prevent them from coming back, prevent gastroesophageal reflux disease

Works best when taken before heartburn occurs

Should not be given to children under 12 without supervision of physician

Proton Pump Inhibitors (PPIs)

Reduce stomach acid and help healing peptic ulcers by block production of stomach acid

Should not be used for 14 days or more frequently than every four months without supervision of physician, should not be given to children under 18

Antidiarrheals

Eliminate diarrhea, not recommended for children under 5 or older adults since it can cause severe dehydration, should not be used for more than 3 days, should be taken with care to maintain hydration

Sometimes contains antiflatulent drugs

3 Categories:

Loperamide

Bismuth sub-salicylate

Digestive enzymes

Diarrhea

3 or more loose stools, typically inflammation of stomach or small intestine, caused by poor nutrition, IBS, viral/bacterial infections, or dysentery

Antiemetics

Used to reduce nausea and vomiting

Risk of dehydration, not recommended for children under 6

Liquid, tablet, chew tablets, and acupuncture bands

Antiflatulants

Help eliminate gas when eating certain foods

Alpha-galactosidase replacements

Lactase replacements

Or after gas has been formed

Simethicone (only OTC Antiflatulent approved for children and infants)

Activated charcoal

Needs to be taken with care for patients with diabetes

Probiotics and diet changes can provide relief

Antihemorroidals

Used to reduce or eliminate hemorrhoids (usually result of stress and strain placed on vein and tissues around anus and lower portion of rectum), but antidiarrheals can be used to treat hemorrhoids

Bleeding hemorrhoids require physician aid

Topical anesthetics include benzocaine and vasoconstrictors

Can include Pramoxine, zinc oxide, glycerin, or mineral

Can also include hydrocortisone as the main ingredient

Not recommended for children under 12

Laxatives

Used to relieve or eliminate constipation, usually can be treated with only OTC

Soften or lubricates stool to aid with constipation and its symptoms, usually works within 72 hours

Should be taken with a full glass of water

Should not be taken within 2 hours of taking other medications, or given to children younger than 6 or those with chronic conditions without physician consult

Different types:

Bulk-forming

Emollient/softening

Lubricant

Saline

Hyperosmotic

Stimulant

Combination

Acne medications

Often: Benzyl peroxide, salicylic acid, sulfur, alpha hydroxyl acid, or combination

Alopecia medications

Minoxidil is the only main ingredient, reduce hair loss

Should not be used in children or pregnant women

Anti-infectives

Topical ointments, creams, or powders that help prevent infections from minor wounds

3 central ingredients combined to make one product:

Bacitracin

Neomycin

Polymyxin B sulfate

May include anesthetic agent to numb affected area

Corn, callus, and wart products

Salicylic acid is the main ingredient, usually very effective, may need to be reapplied

For children, pediatric formulations must be used

Corn, callus

Abnormal skin growths of skin from repeated friction, can become painful at larger sizes

Dandruff medications

Usually a combination of coal tar, salicylic acid, selenium sulfide, ketoconazole

Different categories:

Antimalassezia, inhibits growth of yeast, main ingredient is pyrithione zinc

Selenium sulfide products, works like antimalassezia, should be washed from hair to prevent discoloration

Keratolytics, work as antifungal agents, directions should be followed closely

Coal tar, come in dandruff shampoos, can discolor hair and cause dermatitis if left for extended time periods

Combination, a mix of any of the above

Dandruff

Seborrhea, form of eczema

Dermatitis medications

Common ingredients: Petrolatum, mineral, urea, camphor

Younger children than 2 should be checked by physician

Headlice treatments

____ combs remove nits and their casings from the scalp

Infections untreated repeat cycle every 3 weeks

Primary ingredients: pyrethrins 0.33% or piperonyl butoxide 4%

Directions must be followed exactly to kill infection

Sunscreen

SPF 15+ can be labeled as preventing skin cancer, 30+ is recommended for children

Children below 6 months must use specially formulated

Aloe Vera gel can soothe topically, NSAIDs can reduce swelling and pain

CNS Medication side effects

Confusion, loss of balance, dizziness, or anxiety

Ophthalmic agents

Treat eye disorders, usually eyelid and surrounding tissues, but eyeball issues should not be treated with OTC, forms incudes ointments and drops

Should not be taken long term

3 categories:

Antihistamines

Decongestants

Artificial tears

Ophthalmic antihistamines

Treat watery eyes, itching, burning, and redness associated with allergic rhinitis and seasonal allergies, also work with symptoms of viral conjunctivitis

Approval of children over 3, but physicians should be consulted

Ophthalmic decongestants

Used to treat viral conjunctivitis, taking up to 3 weeks to resolve, includes draining, pinkness, and watery discharge

4 primary ingredients:

Naphazoline

Oxymetazoline

Phenylephrine

Tetrahydrozoline

Generally safe, but should not be taken by children or pregnant women and patients should consult with pharmacist

Artificial tears

Lubricate and cleanse eye, often used in conjunction with ophthalmic antihistamine or decongestant to treat viral + allergic conjunctivitis, dry eyes, and irritation of the eye

Often needed by older adults and those with eye conditions or contact lenses

2 main ingredients:

Hydroxypropyl methylcellulose

Carboxymethylcellulose (CMC)

Usually safe, even for pregnant women

Otic agents

3 categories:

Cerumen-softening products, carbamide peroxide, helps remove excessive ear wax in ear canal

Ear-drying products: Either isopropyl alcohol or anhydrous glycerin, help dry out fluid trapped in ear canal that can lead to infection or pain

Botanical and homeopathic, Olive oil or vitamin E oil, may help ease mild ear pain

Behind the Counter Products (BTC)

Carry some element of risk, but still considered OTC

Includes cough syrups with codeine, pseudoephedrine products, insulin syringes, emergency contraception

Cold Sore medications

Made of docosanol 10%, treats cold sores caused by herpes simplex labialis, painful and frequently recurrent

Patients should frequently wash hands and wash area with hot water and mild soap, then use and OTC oral agent to heal area

Eases pain, itchiness, and swelling, but may need triple antibiotic at outbreak onset

Children should only take with physician supervision

Oral pain agents

Used for tooth pain, teething, irritation from dental equipment, and sores but treating source is important

Can come in topical solutions, cleaning agents, rinses, and protectants

Can be used in children but physician should be consulted

Contraceptives

Help prevent pregnancy and, sometimes STI

Includes:

Spermicidal jellies, foams, and creams

Condoms (usually latex)

Female contraceptive sponges

Smoking Cessation Products

Can be in gum, transdermal patch, spray, and lozenge forms

Gum, lozenge forms are in 2-4 mg strength

Patches are 21,14, and 7 mg strengths and should be used in step down programs

Not for those under 18, with heart defects and other conditions

Consultation with physician is required, therapy guidelines must be followed exactly

Herbal and alternative treatments

Not FDA regulated, not considered tablets or pills since they are plant based

Found as teas, powders, skin gels, liquids, and capsules

Vitamins and dietary supplements are also sold in OTC and are used when there are nutritional deficiencies

Medical devices and diagnostics

Anything that aids a person in the care of their medical needs or conditions, including mobility aids, some need prescription to be covered by insurance

Cholesterol and diabetes products

Blood glucose monitors

Insulin supplies

Urinary Ketone monitoring products

Fertility and pregnancy tests

Nebulizers

Test screening kit