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What does the DEA do?
Enforces the Controlled Substances Act of 1970
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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)
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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
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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
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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
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Who and what is the CDC?
- Centers for Disease Control and Prevention
- Develops and applies disease prevention and control
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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
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What are drug substitution laws?
Specifies whether a pharmacist can automatically dispense a generic equivalent for a prescribed medication, even if not indicated
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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.
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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
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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
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What is pharmacogenetics?
Study of genetic factors predicting a medications action and how it could vary from its intended response
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What is pharmacogenomics?
General study of all genes that determine medication behavior
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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
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What things must go on a medication label?
- Manufacturer's Name
- Dosage Strength
- Form
- Supply Dosage
- Total Volume
- Administration Route
- Label Alerts
- Expiration Date
- Lot or Control Numbers
- Barcode Symbols
- National Drug Code (NDC)
- USP/NF code
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What is a PDR?
- Physicians Desk Reference
- Provides access to information on thousands of medications
- Published annually, contains color coded sections
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What is the American Hospital Formulary Service (AHFS)?
- Reference published annually
- Provides accurate information on almost all prescription meds marketed in the US
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