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Objectives • Describe why over-the-counter (OTC) medications are popular. • List considerations concerning the use of OTC drugs. • Explain the steps involved in medication becoming categorized as over-the-counter. • List a minimum of 5 conditions treated with OTC drugs.
Objectives (cont’d) • Define what a behind-the-counter medication is and how its status differs from OTC items. • Explain why special considerations must be given to both geriatric and pediatric patients in the selection of OTC drugs.
Introduction • OTC medications: no prescriptions necessary • Drugs: common staples in home medicine cabinet • OTC medications are big business and account for 50% of the medication market.
Introduction (cont’d) • Consumers must learn about appropriate dosages and proper use of these medications. • Pharmacists need to know what OTC medications are being taken. • Patients need to know what to avoid. • Buying drugs OTC results in substantial savings; both for the patient and the insurance company.
Why choose to use an OTC medication? • Consumers use OTC products: • To save money • To be involved in their own treatment • Because they are more readily available
Over-the-Counter Drug Considerations There is a wide variety of drugs Identify the cause of the problem. Misuse of drugs contributes to hospital stays. Expiration dates need to be checked. Tamper-proof packaging needs to be checked.
Over-the-Counter Drug Considerations (cont’d) Dosages for children under 2 years not recommended. Many OTC medications have identical ingredients. Manufacturers swap “like ingredients” without notifying the customer. The label will show the change.
Over-the-Counter Drug Considerations (cont’d) No adverse reaction reports required. Patients with special diets, allergies, diabetes, and other medications need to exercise caution. Extra care needed for babies and young children when purchasing.
Three FDA Categories of OTC Drugs FDA classifications: Safe and effective for claimed therapeutic indication Not recognized as safe and effective Additional data must determine whether safe and effective
FDA Regulations Five major safety areas: Purity Potency Bioavailability Efficacy Safety and toxicity
Purity Purity of a product represents the lack of contamination from environmental factors of the chemical (drug) contained in the product. Additives include fillers, dyes, solvents, buffers, and waxes. Various ingredients increase the size of the medication, decrease absorption, improve taste.
Potency Refers to the strength of the drug Measurement in: grams (g) milligrams (mg) micrograms (mcg or μg) Drug tested on research animals Strength measured in units
Bioavailability Level at which a drug is both absorbed and transported to the site of action Measured by the concentration of the drug in the blood or tissue at the peak time of administration
Efficacy The ability of the drug to produce the desired effects in the body Clinical trials judge effectiveness Variances affect end results Variance: unknown health conditions, age, weight, lifestyle, gender, and genetics
Safety and Toxicity Represent opposite effects of a drug being studied Lab animals used as test subjects in beginning stages of trials Later years, published results include effects of drugs on pregnancy
Safety and Toxicity (cont’d) Any drug can be toxic if not taken correctly. Difference between toxic and desirable effects documented. Difference “margin of safety.” Drug falls into “margin of safety” is “therapeutic dose.”
How a Prescription DrugBecomes an OTC Drug Amount of research is extensive. FDA approves all new drugs entering the marketplace. FDA uses three phases of testing. Monograph gives information about a drug.
Three FDA phases of OTC drug approval: Phase 1: Advisers evaluate agent for safety and efficacy. Phase 2: Final review done on ingredients. Phase 3: After evidence presented and all aspects of the agent are exhausted, the final monograph is published. How a Prescription DrugBecomes an OTC Drug (cont’d)
Agent meets criteria—approved as an OTC drug. Some legend drugs become OTC—strength is lowered. Legend Ibuprofen strength (400, 600, or 800 mg). OTC Ibuprofen strength (200 mg). How a Prescription DrugBecomes an OTC Drug (cont’d)
Conditions Treated with OTC Drugs For common types of OTC products, symptoms treated, and routes of administration, see Table 8-3. As new medications enter the market as OTC drugs, consumers can choose new routes of administration.
OTC Agents: Patient Information Analgesics and antipyretics: help reduce or relieve pain and fever. Aspirin: antiinflammatory agent; decreases platelets; prophylaxis to decrease risk of blood clotting in heart disease and stroke. SeeTable 8-4. Associated with Reye’s syndrome.
Analgesics and Antipyretic Products ConditionProductDosage Forms Fever/pain Acetaminophen Tab, cap, (Tylenol) liq, supp Fever/pain Aspirin (Bayer, Tab, cap, Alka-Seltzer) powder Fever/pain Ibuprofen (Motrin) Tab, cap, liq Pain/arthritis Capsaicin (Zostrix) Top Tab, Tablet; cap, capsule; liq, liquid; top, topical; supp, suppository.
Interactions Between Aspirin and Other Agents For a list of common interactions, see Table 8-5. Technicians should alert pharmacist about any interactions they notice. Technicians must refer patients to the pharmacist for counseling about interactions.
Headache Products Analgesics Some contain additives: caffeine Migraines: prescription drug required
Headache Products (cont’d) ConditionProductDosage Forms Severe ASA/caffeine/headache/migraine acetaminophen combination (Excedrin) Tab Caplet ASA/calcium carbonate combination (Bayer Women’s Aspirin Plus Calcium) Caplet Acetaminophen/ caffeine combination (Excedrin Tension Headache [aspirin free]) ASA, Acetylsalicylic acid (aspirin); tab, tablet.
Antiinflammatories Nonsteroidal antiinflammatory drugs (NSAIDs) treat inflammation. They reduce pain. They are used as antipyretic and analgesic. May cause drowsiness, upset stomach; take with food or milk.
Allergy and Cold Agents For relief of common cold: decongestants and antihistamines. Decongestants dry out membranes, open airways, cause vasoconstriction, reduce congestion. Antihistamines: used with allergic symptoms; action blocks histamine (H-1) that causes allergic reaction.
Decongestants Decongestants are ndicated for stuffiness and congestion of nasal passages and sinuses. They act to open passages and allow release of mucus. Used for chest congestion: permit coughing up of phlegm. Are available in both OTC and prescription preparations.
Decongestant Products ConditionProductDosage Forms Common Oxymetazoline Spraycold/allergies (Afrin) Phenylephrine Spray (Neo-Synephrine) Normal saline Spray (Ocean) Common cold Pseudoephedrine* Tab, cap, liq (Sudafed) Clemastine (Tavist) Tab, liq Tab, Tablet; cap, capsule; liq, liquid.*Pseudoephedrine (Sudafed) is a decongestant and is less likely to cause drowsiness. It is used exclusively as a decongestant, not for allergies.
Antihistamines First-generation: common side effect is sleepiness. Second-generation: require a prescription and do not cause drowsiness.
Antihistamine Products ConditionProductDosage Forms Congested Chlorpheniramine Tab, capnose, sinus (Chlor-Trimeton) Diphenhydramine Tab, cap, liq (Benadryl) Loratadine Tab, cap (Claritin) Tab, Tablet; cap, capsule; liq, liquid.*These agents also come in many combinations with agents that treat cough, fever, and pain.
Sleep Aids Diphenhydramine or magnesium salicylate used to treat insomnia. For a list of antiinsomnia products, see Table 8-10. Diphenhydramine: the most commonly prescribed agent ordered in hospitals for sleep.
Sleep Aids(cont’d) May cause drowsiness. Avoid alcoholic beverages. Do not use if suffering with asthma, glaucoma, emphysema, or an enlarged prostate. For chronic insomnia consult a physician.
Cough Medicines Largest OTC section: cold and flu For congested coughs: expectorants For dry non–phlegm-producing coughs: cough suppressants Do not use if suffering with asthma, glaucoma, emphysema, heart problems, or an enlarged prostate
Cold and Cough Products ConditionProductDosage Forms Congested cough Guaifenesin/ pseudoephedrine (Robitussin PE) Tab, liq, syr Guaifenesin (Robitussin) Tab, cap, syr Dry cough Guaifenesin/ dextromethorphan (Robitussin DM) Liq, syr Tab, Tablet; liq, liquid; syr, syrup; cap, capsule.
Sore Throat Products Cold or flu: causes of sore, scratchy, and dry throats Sore throat: can be symptom of Strep throat (treat with antibiotics) Syrups and sprays: relieve throat pain Phenol, menthol, alcohol, and benzocaine
Sore Throat Products (cont’d) ConditionProductDosage Forms Sore throat Benzocaine (Chloraseptic) Lozenges Dyclonine (Sucrets) Lozenges
Stomach Remedies/Antacids Common upset stomach remedies Histamine-2 (H2) antagonists—decrease acid secretions (heartburn) Proton pump inhibitors: relieve acid secretions Antacids used to balance pH level in stomach; for short-term heartburn relief
Stomach Products/Antacids ConditionProductDosage Forms Heartburn Cimetidine (Tagamet-HB) Tab, liq Ranitidine (Zantac-75) Tab Famotidine (Pepcid-AC) Tab Nizatidine (Axid-AR) Tab Antacids Calcium hydroxate (Tums) Chewable tab Aluminum hydroxide/magnesium Tab, liq, gelcap hydroxide/simethicone (Mylanta)Tab, Tablet; liq, liquid.
Intestinal Remedies Intestinal discomfort: constipation, diarrhea, gas (flatulence) Intestinal products contain oil or saline solution For diarrhea: anticholinergic agent, bulk-forming fiber
Intestinal Products ConditionProductDosage Forms Constipation Combination stimulant (Ex-Lax) Tab, chew tab Stool softeners Docusate sodium (Colace) Gelcap Diarrhea Loperamide (Imodium A-D) Tab, cap, liq Flatulence Simethicone (Mylicon) Tab, chew tab, liq Irregular bowels Psyllium (Metamucil) Powder Tab, Tablet; cap, caplet; liq, liquid.
Intestinal Remedies Loperamide, Metamucil Most commonly used gas treatment is simethicone (Gas-X). Laxatives: do not use if abdominal pain, nausea, and vomiting are present. Loperamide: may cause drowsiness or dizziness.
Skin Remedies For a list of common dosage forms and types of conditions they treat, see Table 8-15. For popular antibiotic ointments and creams, see Table 8-16.
Geriatric and Pediatric Considerations More OTC drugs available in different dosage forms, strengths, and combinations than legend drugs. Many senior citizens buy their medications OTC due to a lack of insurance benefits and may choose the wrong medication.
Geriatric and Pediatric Considerations (cont’d) Infants and children run a risk of being given an inappropriate medication, a wrong dose or the wrong drug product for their age.
Behind-the-Counter • Several countries that have a third class of drugs that are referred to as behind-the-counter (BTC). • There are certain drugs that are kept behind the counter here in the United States. • Emergency contraceptive (Plan B) • Products containing pseudoephedrine and ephedrine