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?