Over The Counter Drugs(OTC)

Dina R. Utter

MSN Student

Viterbo University

Prescription vs. Non Prescription (OTC) Drugs

Determined by the U.S. Food and Drug Administration (FDA).

FDA also decides when a prescription drug can be used as an OTC drug.

Center for drug evaluation and Research (CDER), a branch of FDA oversees OTC drugs and prescription drugs.

OTC Drug History

1938: Federal Food Drug Cosmetic Act (FFDCA) drug safety requirement.

1951: Durham-Humphrey Amendments to Federal Food, Drug and Cosmetic Act (FFDCA)

designated drugs that cannot be used safely

without professional supervision as prescription

drugs and all other drugs as OTC.

OTC Drug History

1962: Drug Amendments to FFDCA added

efficacy requirement. Drug Efficacy Study Implementation (DESI) retrospective review of efficacy of 1938 - 1962

New Drug Application (NDA) began in 1966. 1972: FDA established OTC drug review

procedures for classification of all OTC drugs on the market.

OTC Drug History

In order for an OTC drug active ingredient to be included in an OTC monograph it must have been marked prior to May 11, 1972.

Two legal pathways for OTC drug marketing post 1938. Marketing in compliance with drug monograph Marketing under the authority of an approved New drug

application (NDA). Any medication proposed for OTC availability after

May 11, 1972 must undergo the new drug application (NDA) process.

OTC Drug Review Process

Designed to produce OTC monographs

(regulatory standards) for marketing of nonprescription drug products not covered by NDA

OTC monographs describe ingredients,

indications, and labeling requirements for OTC products that are recognized as safe and effective

OTC Drug Review ProcessPhase I

First Phase: Accomplished by advisory review panels

These advisory panels Review the ingredients to determine safety and

effectiveness for self treatment. Appropriate labeling: including therapeutic indications,

dosage instructions and warnings about side effects and preventing misuse

OTC drug review Phase I cont.

Advisory panel: Classifies drug ingredients into three categories: Category I: safe and effective for the claimed therapeutic

indication Category II: not as safe and effective or unacceptable

indications Category III: Insufficient data available to permit final

classification.

OTC Drug ReviewPhase II

The agency reviews ingredients in each class of drugs based on. The panel’s findings, public comment, and any

new data that may have become available. The agency publishes conclusions in the

Federal Register in the form of a proposed monograph.

Time is allotted for objections to the proposal or for request for a hearing before the commissioner of the FDA.

OTC Drug ReviewPhase III

The publication of the final drug monograph.

The monographs establish conditions under which certain OTC drugs are recognized as safe and effective.

OTC Drug Monograph

Final OTC monograph establishes the acceptable:

• active ingredients

• concentration of the active ingredients

• therapeutic claims

• indications

• labeling/warning requirements

• directions for use

Sample OTC Labeling (Monograph)

Drug FactsActive ingredient Purpose

XXXXXXXXXXXXXX.............................................................................Antifungal

Uses cures most athlete’s foot (tinea pedis) relieves itching, burning, cracking, and scaling.

WarningsFor external use only Do not use on children under 2 years of age unless directed by a doctorWhen using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions wash the affected area and dry thoroughly. apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product. for athlete’s foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. use daily for 4 weeks. If condition persist longer, ask a doctor. This product is not effective on scalp or nails

Other information XXXXXXXInactive ingredients XXXXXXXQuestions or comments? Call 1-800-XXX-XXXX.

Prescription to OTC switch

Examples of OTC switch:

OTC Switch

Occurs when NDA holder of approved prescription drug files NDA or supplement for approval of OTC product.

The NDA holder may gain 3 years of marketingexclusivity for OTC “conditions of use” if switch isbased on:

New clinical investigation(s) Conducted or sponsored by the applicant Essential to approval

OTC Switch Candidates Acceptable margin of safety based on prior

prescriptionmarketing experience.

OTC dosages/indications are relatively safe low misuse potential minimal abuse potential reasonable therapeutic window of safety

Self treatment and monitoring with minimal physiciansupervision.

Adequately labeled to allow safe and effective use of the

OTC drug and benefits from the switch clearly outweigh the risks.

OTC Switch

Final Thoughts

Imagine what it would be like if OTC medications were not so rigoursly monitored.

Wouldn’t you love to call your primary care provider (PCP) every time you had a cold, headache or a fever.

References

Federal Food and Drug Administration. http://www.fda.gov. Retrieved February 22, 2005.

Rules and regulations. Federal Register, 67 (15). Retrieved February 22, 2005, http://www.fda.gov.