1. what is not included in the definition of a drug product?
  2. What is a substance used in the diagnosis, prevention, or treatment of a disease or a medical condition?
  3. what information is essential to know for safe administration of a drug?
    • appropriate dose
    • route of administration
    • indication for use
    • side effects
    • relevant drug interactions
    • contraindications
    • interventions in case of an emergency
  4. a collection of drug information in a specific geographic area
  5. the use of experience or statistical probabilities for making drug choices
  6. a drug secured by a prescription
    legend drug
  7. the ability of a generic drug to reach blood levels equivalent to those reached by a brand-name drug
    biologic equivalence
  8. How is a legend drug obtained?
    only through a prescription
  9. All drugs have an official name called the _________ name
  10. The proprietary name for a drug is the called the _________ name
  11. biologic equivalence is equal to _________ equivalence
  12. What is the time period of patent protection for the manufacture and marketing of a drug?
    17 years
  13. approve drugs that have been safe and effectivetests food products to ensure they are safe to consumeregulate labeling and packaging of drug productsestablish standards for purity and strengthoversees quality control in drug manufacturing facilitiestakes pharmacologic products off the market when standards are not metdecides what drugs can be sold OTC or are sold by prescriptionregulates claims on labels and advertisements of prescription drugs
    FDA functions
  14. What agency oversees nonprescription drug products?
    federal trade commission (FTC)
  15. Describe the differences between drug trial phases. What is the chance that all ADEs are identified when all the phases are completed?
    • They are first tried on animals, then checked for safedty, then checked for effectiveness, then checked to identify ADE's
    • the chances are very unlikely that all the ADE's are indentified
  16. What groups are often excluded in drug trials?
    • children
    • women
    • elderly
  17. What is the purpose of postmarket surveillance?
    to determine the true risk-benefit profile of the new drug
  18. The CSA is administered by which U.S. government agency?
    comprehensive Drug abuse prevention and control act of 1970
  19. which act identifies rules for writing prescriptions for narcotics in the U.S.? which governmental agency enforces this act?
    • Harrison Narcotics act HNA
    • CSA
  20. Identify sources for dentally related drug information that provides fast retrieval of drug information tthat provides fast retrieval of drug information relevant to dental hygiene practice
    • facts and comparisons
    • the US pharmacopeia drug information
    • american hospital formulary service drug information
    • mosby's dental drug reference
  21. Describe 3 ways the RDH applies knowledge of pharmacology
    • enter drugs used int the tx record
    • to do a history review
    • know dose and route of administration
  22. What 4 items of information should be included on a drug card?
    • drug name
    • indications
    • side effects
    • clinical implications
    • OH info
Card Set
week one