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May 22, 2013
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Prescription Medicine (cont.)

Medical Author:
Omudhome Ogbru, PharmD

Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

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Medical Editor:
Charles Patrick Davis, MD, PhD
Charles Patrick Davis, MD, PhD
Charles Patrick Davis, MD, PhD

Dr. Charles "Pat" Davis, MD, PhD, is a board certified Emergency Medicine doctor who currently practices as a consultant and staff member for hospitals. He has a PhD in Microbiology (UT at Austin), and the MD (Univ. Texas Medical Branch, Galveston). He is a Clinical Professor (retired) in the Division of Emergency Medicine, UT Health Science Center at San Antonio, and has been the Chief of Emergency Medicine at UT Medical Branch and at UTHSCSA with over 250 publications.

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Historical Background of Prescription Medications

  • The regulation of drugs in the United States began with the Import Drugs Act of 1846, enacted after Mexico sold the US Army tainted drugs to treat malaria.

  • In 1906, the Food and Drug Administration (FDA) was formed, primarily to regulate commerce and to combat the then rampant adulteration (debasement or dilution of a substance by adding other material) of foods and drugs.

  • The FDA was not empowered to address drug safety issues until 1938, following the unnecessary deaths of 107 children from a new drug preparation. This incident led to laws that required drugs be proven safe before they were allowed on the market.

  • The last major regulatory change was the provision of the FDA in 1962 that drugs be proven to be effective as well as safe before they could be used.

  • Today, the FDA continues to regulate all drugs sold in the US, both by insuring that they are safe and effective in what they do before they are released and by limiting their distribution by deciding which medications require a prescription to be sold.

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The FDA has approved first-time generic formulations for oxycodone hydrochloride and ibuprofen tablets in 5 mg/400 mg strength, extended phenytoin sodium capsules in 30-mg strength, and fomepizole injectable in 1 g/mL strength.

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