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What does the DEA do?
Enforces the Controlled Substances Act of 1970
What is the Pure Food and Drug Act of 1906?
- Required all drugs to be uniform in ingredients, strength, purity and quality
- Required preparations containing morphine to be labeled
- Established United States Pharmacopoeia (USP) and the National Formulary (NF)
What is the Federal Food, Drug and Cosmetic Act?
- Established the FDA
- Warning labels on preparations, cautions regarding drowsiness or addictiveness
- All drugs must be safe
- Required FDA approval for all drugs
- Designated OTC and Prescription drugs
What is the Controlled Substances Act of 1970?
- Established the DEA
- Created stricter guidelines for controlled substances
- Required each prescriber register with the DEA
- Identified addictive drugs and classified them into schedules
Who and what is OSHA?
- Occupational Safety and Health Administration
- Ensures safety and health of American workers by setting standards and guidelines
- Involved with Surg Tech due to the Occupational Exposure to Bloodborne Pathogens Standard
Who and what is the CDC?
- Centers for Disease Control and Prevention
- Develops and applies disease prevention and control
What are "practice acts?"
- State laws governing ordering, dispensing and administration of meds
- Also regulates pharmacy actions by determing how and who should dispense medication
What are drug substitution laws?
Specifies whether a pharmacist can automatically dispense a generic equivalent for a prescribed medication, even if not indicated
Who and what is JCAHO?
- Joint Commission on Accredidation of Healthcare Organizations
- Evaluates and accredits approximately 16,000 health care organizations and programs in the United States
- Includes hospitals, critical access hospitals, ambulatory hospitals and outpatient surgical facilities.
Who and what is the FDA?
- Food and Drug Administration
- Regulates the pharmaceutical industry
- Reviews new drug applications
- Investigates facilities where drugs are made
- Investigates and removes unsafe drugs from the market
What is JCAHO's "do not use" list?
- List of dangerous abbreviations
- U for unit, use "unit" instead
- IU for international unit. Mistaken for IV, write out the word
- Q.D., Q.O.D., mistaken for each other, write "daily and every other day"
- Trailing zero's or lack of leading zero in a decimal. Never write single 0 after a decimal point. Always use a zero before a decimal point
What is pharmacogenetics?
Study of genetic factors predicting a medications action and how it could vary from its intended response
What is pharmacogenomics?
General study of all genes that determine medication behavior
Who and what is the USP and NF?
- United States Pharmacopoeia and National Formulary
- Assigns generic names to medications
- Publication that lists standards for medication quality, safety, and effectiveness
- Revised every 5 years
What things must go on a medication label?
- Manufacturer's Name
- Dosage Strength
- Supply Dosage
- Total Volume
- Administration Route
- Label Alerts
- Expiration Date
- Lot or Control Numbers
- Barcode Symbols
- National Drug Code (NDC)
- USP/NF code
What is a PDR?
- Physicians Desk Reference
- Provides access to information on thousands of medications
- Published annually, contains color coded sections
What is the American Hospital Formulary Service (AHFS)?
- Reference published annually
- Provides accurate information on almost all prescription meds marketed in the US