1. Over The Counter Drugs (OTC) Dina R. Utter MSN Student Viterbo University

2. 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.

3. 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.

4. 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 onthe market.

5. 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.

6. 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

7. OTC Drug Review Process Phase 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

8. 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.

9. OTC Drug Review Phase II The agency reviews ingredients in each class of drugs based on. The panels 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.

10. OTC Drug Review Phase III The publication of the final drug monograph. The monographs establish conditions under which certain OTC drugs are recognized as safe and effective.

11. 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

12. Sample OTC Labeling (Monograph) Drug Facts Active ingredient Purpose XXXXXXXXXXXXXX.............................................................................Antifungal Uses cures most athletes 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 athletes 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.

13. Prescription to OTC switch Examples of OTC switch:

14. OTC Switch Occurs when NDA holder ofapproved prescription drug files NDA or supplement for approval of OTC product. The NDA holder may gain 3 years of marketing exclusivity for OTC conditions of use if switch is based on: New clinical investigation(s) Conducted or sponsored by the applicant Essential to approval

15. OTC Switch Candidates Acceptable margin of safety based on prior prescription marketing experience. OTC dosages/indications are relatively safe low misuse potential minimal abuse potential reasonable therapeutic window of safety Self treatment and monitoring with minimal physician supervision. Adequately labeled to allow safe and effective use of the OTC drug and benefits from the switch clearly outweigh the risks.

16. OTC Switch

17. Final Thoughts Imagine what it would be like if OTC medications were not so rigoursly monitored. Wouldnt you love to call your primary care provider (PCP) every time you had a cold, headache or a fever.

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