Chapter 16:Chapter 16:Over-the-Counter Over-the-Counter

(OTC)(OTC)and Prescription Drugsand Prescription Drugs

Prescription & OTC DrugsPrescription & OTC Drugs

PrescriptionPrescription drugs are available only by drugs are available only by recommendation of an authorized health recommendation of an authorized health professional, such as a physician.professional, such as a physician.

NonprescriptionNonprescription (over-the-counter, or (over-the-counter, or OTC) drugs are available on request and OTC) drugs are available on request and do not require approval by a health do not require approval by a health professional.professional.

Prescription & OTC DrugsPrescription & OTC Drugs Prescription and OTC drugs have been Prescription and OTC drugs have been

viewed differently by the public sine the viewed differently by the public sine the classifications were established by the classifications were established by the Durham-Humphrey Amendment of 1951.Durham-Humphrey Amendment of 1951.

In general, the public views OTC drugs as In general, the public views OTC drugs as minimally effective and safe and minimally effective and safe and prescription drugs as more potent and prescription drugs as more potent and frequently dangerousfrequently dangerous

However, these distinctions are not always However, these distinctions are not always accurateaccurate

Each year the U.S. spends over $14 billion Each year the U.S. spends over $14 billion on on OTC drugsOTC drugs

More than 300,000 different OTC products More than 300,000 different OTC products are available on the marketare available on the market

OTC expenditures comprise 60% of the OTC expenditures comprise 60% of the annual drug purchase in the U.S.annual drug purchase in the U.S.

An estimated 3 out of 4 people routinely self-An estimated 3 out of 4 people routinely self-medicate with these drug productsmedicate with these drug products

OTC Drugs Interesting FactsOTC Drugs Interesting Facts

Abuse of OTC productsAbuse of OTC products

OTC products generally have a greater OTC products generally have a greater margin of safety than their prescription margin of safety than their prescription counterparts, but issues of abuse need to counterparts, but issues of abuse need to be considered. be considered.

Physical dependencePhysical dependence Psychological dependencePsychological dependence

Abuse of OTC productsAbuse of OTC products Nonprescription products that can be Nonprescription products that can be

severely habit-forming: decongestants, severely habit-forming: decongestants, laxatives, antihistamines, sleep aids, laxatives, antihistamines, sleep aids, antacids and ephedrine.antacids and ephedrine.

The active ingredients in OTC drugs have The active ingredients in OTC drugs have been classified and placed in category I been classified and placed in category I (considered safe and effective)(considered safe and effective)

However, as recently as 1992, the FDA has However, as recently as 1992, the FDA has banned over 400 ingredients from 7 banned over 400 ingredients from 7 categories of OTC products.categories of OTC products.

““Switching” policy of the FDASwitching” policy of the FDA

The FDA is attempting to make more drugs The FDA is attempting to make more drugs available to the general public by available to the general public by switching some frequently used and safe switching some frequently used and safe prescription medications to OTC status.prescription medications to OTC status.

This policy is in response to public demand This policy is in response to public demand to have access to effective drugs for self-to have access to effective drugs for self-medication and has resulted in over 63 medication and has resulted in over 63

switched ingredients, such as ulcer and switched ingredients, such as ulcer and hair-growing medicationshair-growing medications

OTC drugs and self-careOTC drugs and self-care

More than one-third of the time people treat More than one-third of the time people treat their routine health problems with OTC their routine health problems with OTC medications to receive symptomatic medications to receive symptomatic

relief relief from their ailments.from their ailments. If done correctly, self-care with OTC If done correctly, self-care with OTC

medications can provide significant relief medications can provide significant relief from minor, self-limiting health problems from minor, self-limiting health problems at minimal cost.at minimal cost.

OTC LabelsOTC Labels

Required label information includesRequired label information includes:: Approved uses of the productApproved uses of the product Detailed instructions on safe and effective use Detailed instructions on safe and effective use Cautions or warnings to those at greatest risk Cautions or warnings to those at greatest risk

when taking the medicationwhen taking the medication

Label information controlled by the FDALabel information controlled by the FDA

OTCAntacids

Ingredients:12 fl. oz.

GOTCHA,INC.

IndicationsDirections:Warnings:Precautions:Expirationdate:

Product name

Identity

Activeingredients

Quantity

Manufacturer

When to use

How to use

What to watch for

Possible druginteractions

When drugshould nolonger beused

Rules for proper OTC drug useRules for proper OTC drug use

Always know what you are taking.Always know what you are taking. Know the effects.Know the effects. Read and heed the warnings and cautions.Read and heed the warnings and cautions. Don’t use anything for more than 1 to 2 wks.Don’t use anything for more than 1 to 2 wks. Be particularly cautious if also taking Be particularly cautious if also taking

prescription drugs.prescription drugs. If you have questions, ask a pharmacist.If you have questions, ask a pharmacist. If you don’t need it, don’t use it!If you don’t need it, don’t use it!

Types of OTC drugsTypes of OTC drugs

Internal analgesicsInternal analgesics AnalgesicsAnalgesics SalicylatesSalicylates

Therapeutic considerationsTherapeutic considerations Analgesic actionsAnalgesic actions Anti-inflammatory effectsAnti-inflammatory effects Antipyretic effectsAntipyretic effects Side effectsSide effects

Types of OTC drugsTypes of OTC drugs Cold, allergy and cough remediesCold, allergy and cough remedies

DecongestantsDecongestants AntitussivesAntitussives ExpectorantsExpectorants Vitamin CVitamin C

Sleep aidsSleep aids MelatoninMelatonin

StimulantsStimulants “ “Look-alike” and “act-alike” drugsLook-alike” and “act-alike” drugs

Types of OTC drugsTypes of OTC drugs

Gastrointestinal medicationGastrointestinal medication Antacids and anti-heartburn medicationAntacids and anti-heartburn medication

Diet aidsDiet aids Skin productsSkin products

Acne medicationsAcne medications Sun productsSun products

Skin first-aid productsSkin first-aid products OTC herbal productsOTC herbal products

Prescription drugsPrescription drugs

There are currently more than 10,000 There are currently more than 10,000 prescription products sold in the United prescription products sold in the United States, representingStates, representing Approximately 1500 different drugsApproximately 1500 different drugs With 20 to 50 new medications approved each With 20 to 50 new medications approved each

year by the FDAyear by the FDA

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Prescription drugsPrescription drugs

According to the Durham-Humphrey According to the Durham-Humphrey Amendment of 1951, drugs are controlled Amendment of 1951, drugs are controlled with prescription if they are:with prescription if they are: Habit-forming Habit-forming Not safe for self-medicationNot safe for self-medication Intended to treat ailments that require the Intended to treat ailments that require the

supervisions of a health professionalsupervisions of a health professional New and without an established safe track recordNew and without an established safe track record

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Doctor-patient communicationDoctor-patient communication When a physician prescribes a drug, a patient When a physician prescribes a drug, a patient

should insist on answers to the should insist on answers to the following following questions:questions:

What is the desired outcome?What is the desired outcome? What are the possible side effects of the What are the possible side effects of the

drug?drug? How should the drug be taken to minimize How should the drug be taken to minimize

problems and maximize benefits?problems and maximize benefits?

Generic and proprietary drugsGeneric and proprietary drugs

GenericGeneric is the official, nonpatented, is the official, nonpatented, nonproprietary name of a drug. The term nonproprietary name of a drug. The term generic is used by the public to refer to generic is used by the public to refer to

the the common name of a drug that is not common name of a drug that is not subject subject to trademark rights.to trademark rights.

ProprietaryProprietary a brand or trademark name that is a brand or trademark name that is registered with the U.S. Patent Office. registered with the U.S. Patent Office. Proprietary denoted medications Proprietary denoted medications

marketed marketed under specific brand names, i.e., under specific brand names, i.e., Valium.Valium.

Common categories of Common categories of prescription drugsprescription drugs

AnalgesicsAnalgesics Low-potency (Darvon)Low-potency (Darvon) Moderate potency (Percodan)Moderate potency (Percodan) High-potency (Demerol)High-potency (Demerol)

AntibioticsAntibiotics AntibacterialsAntibacterials

Antidepressants Antidepressants

Common categories of Common categories of prescription drugsprescription drugs

Antidiabetic drugsAntidiabetic drugs Antiepileptic drugsAntiepileptic drugs Antiulcer drugsAntiulcer drugs BronchodilatorsBronchodilators

Common categories of Common categories of prescription drugsprescription drugs

Cardiovascular drugsCardiovascular drugs Antihypertensive agentsAntihypertensive agents Antianginal agentsAntianginal agents Drugs to treat congestive heart failureDrugs to treat congestive heart failure Cholesterol and lipid-lowering drugsCholesterol and lipid-lowering drugs

Hormone-related drugsHormone-related drugs Sedative-hypnotic agentsSedative-hypnotic agents Drugs to treat HIVDrugs to treat HIV