Overview

Self-Care

those activities that individuals, families, and communities undertake with the intention of enhancing health, preventing disease, limiting illness, and restoring health

Pure Food and Drug Act of 1906

standards of strength, quality, and purity

Federal Food, Drug, and Cosmetic Act of 1938

drugs mandated safety

Durham-Humphrey Act of 1951

established 2 classes: prescription and nonprescription

Kefauver-Harris Amendment of 1962

effective and sage

Dietary Supplement Health Education Act (DSHEA) 1994

dietary supplements must be safe

Center for Drug Evaluation and Research (CDER)

division of FDA; oversees Rx and nonprescription meds (formulation, production, distribution, proper labeling)

Active ingredient

active components and strength; purpose

Uses

symptoms or conditions this product will treat

Warnings

caution with medical conditions, meds, or side effects; special populations

Directions

number and frequency of doses to take

Other information

storage requirements

Inactive ingredients

colors and fillers

Complete switch

product becomes nonprescription, no Rx version remains

Partial switch

one or more doses that were Rx became OTC; lower strengths normally become OTC

Rx-to-OTC switch
3 questions to answer:

1. Can the patient self-diagnose the clinical abnormality?
2. Can the condition be successfully self-treated?
3. Is the self-treatment product safe and effective for consumer use?