Law Chapter 2 Part 1

  1. Pure Food and Drug Act
    • assurance of pharmaceutical safety
    • labeling law
    • written materials must be truthful and not misleading
  2. Federal Food and Drug Cosmetic Act
    • test for safety before drug enters market
    • direct regulation
    • catalyst for law was sulfanilamide
  3. Durham Humphrey Amendment
    • Distinguished Rx and OTC drugs
    • legalized verbal transmiision of Rx
    • Legalized refill authorizations
    • Rx drugs had to state dispensing prohibited w/o Rx
    • Proper OTC use labeling
  4. Kefauver Harris Amendment
    • brought about by thalidomide
    • requires drugs to be proven safe and effective
    • retroactive to 1938
    • established GMP requirements
  5. Medical Device Amendments
    • classification of devices according to function
    • premarket approval
    • est. performance standards
    • confomance with GMP
    • record and reporting requirements
  6. Class 1 devices
    • general controls
    • least control
    • minimum potential harm
    • bandages, gloves, surgical instruments
  7. Class 2 devices
    • special controls
    • special labeling requirements
    • mandatory performance standards
    • post market surveillance
    • powered wheelchairs, infusion pumps, surgical drapes
  8. Class 3 devices
    • most stringent regulation
    • devices that support human life
    • require pre-market approval
    • replacement heart valves, breast implants, pacemakers
  9. Prescription Drug Marketing Act
    • States liscense wholesale distriutors of rx drugs
    • bans re-importation
    • bans sale, trade or purchase of samples
  10. Federal Food and Drug Administration
    • under deparment of health and human services
    • authority for FDCA
    • secretary appointed by president
  11. Structure of FDA
    • Five centers
    • Biologics Evaluation & Research
    • Food Safety and Applied Nutrition
    • Drug Evaluation and Research
    • Veterinary Medicine
    • Devices & Radiological Health
  12. Functions of FDA
    • Rulemaking
    • Issue guidance documents
    • incorporate advice from advisory committees of outside experts
  13. FDA makes rules about
    • interstate commerce
    • adulteration
    • misbranding
  14. Food and Drug Administration Amendments Act
    enhances FDAs responsibilies to regulate drug safety
  15. FDA's responsibilties reguarding drug safety
    • labeling related to safety
    • clinical trial data reporting and registries
    • postmarket clinical trials to asses risk
    • requirement of REMS when necessary
    • website reguarding safety
  16. Post market clinical trials to asses risks
    • phase 4 trials
    • FDA can require more testing from manufacturer if problems arrise in the market
    • FDA can mandate a black box warning
  17. REMS
    Risk evaluation and mitigation strategies
  18. Goal of REMS
    • minimize known risks of a product while maximizing its benefits
    • drugs are misbranded if they do not have the correct labeling
  19. Penalty for violation of REMS
    • $250,000
    • penalty increases if the violation continues more than 30 days after notification by the FDA
  20. REMS is developed by ____ and approved by ___.
    developed by manufacturers and approved by FDA
  21. Most frequent requirement of REMS
    Patient directed information
  22. Patient directed instructional document
    • medication guide
    • patient package insert
  23. MedGuides are required if the FDA determines that one or more of the following exist
    • patient directed labeling for the drug may help prevent serious ADEs
    • drug has serious risks relative to benefits
    • drug product is important for health and pt's adherance to instructions is crucial to effectiveness
  24. Communication that the FDA can require as part of REMS
    • sending letters to health care professionals
    • explain safey protocols/monitoring required
    • info about serious risks associated with the drug
  25. Elements to assure safe use (ETASU)
    guidelines intended to provide patients with safe acces to drugs taht are associated with a serious risk and would be removed from the market if not for REMS
  26. ETASU guidelines may be required by REMS to include the following
    • special training for HC providers
    • specially certified pharmacies/practitioners
    • only dispense drug in a hospital
    • restrictions on dispensing only if pt has labs
    • pt is subject to certain monitoring
    • pt must be enrolled in a registry
  27. Health care provider certification is completed by
    • the manufacturer
    • optional training from FDA
  28. In order to be certified, the health care provider may be required to show the ability to:
    • diagnose the condition indicated for the drug
    • understand risk/benefits of the product
    • diagnose and treat potential ADRs from the drug
  29. Pharmacies certified to dispense a certain product may be required to demonstrate that they
    • understand risk/benefits of the product
    • agree to refill only with authorization
    • agree to check labs or stickers
    • agree to fill rx within an alloted time of writing
    • agree to fill only from certified providers
  30. Evidence or other documentation demonstrating safe use conditions may include the following
    • pt have been counseled about risk/benefit & signed
    • pt provided educational materials & demonstrate understanding
    • pt receives drug only after special authroization and verification from the pharmacy
  31. Patient Registries may collect information on enrolled patients that includes
    • information about clinical outcomes
    • clinical and lab data
    • safety information
    • data about compliance w/ management and rx protocols
    • data about the impact of tools to ensure compliance and good outcomes
  32. What is a drug?
    • recognized by the USP or Homeopathic pharmacopeia
    • used in diagnosis, cure, mitigation, treatment or prevention of disease
    • effect structure and function of body (not food)
    • almost anything with an intended therapeutic purpouse
  33. Food vs drug
    • foods found to be drugs can be removed from the market
    • structure/function claims are acceptable for food
    • treatment, diagnosis, mitigation, & cure claims are not acceptable
  34. Nutrition Labeling and education act allows food to
    contain helath claims if approved by the FDA or significant scientific agreement
  35. Dietary Supplement Health and Education Act defines a dietary supplement as a product that is
    • intended for ingestion
    • intended to supplement the diet
    • contains: vitamin, mineral, herb/botanical, amino acid, supplements to the diet, any combo of the previous
  36. Device vs drug
    • device does not achieve its intended purpous through chemical action
    • in not dependent on being metabolized
  37. Cosmetic vs. drug
    cosmetic becomes a drug if mfg promotes it for a therapeutic perpose, despite chemistry
  38. Definition of a Label
    • written, printed or graphic matter upon the immediate container
    • includes container or wrapper
  39. Labeling
    • labels
    • written matterials or wrappers accompanying the drug
    • information not sent directly with the drug if part of an integrated distribution process
  40. Rx labeling is directed to
    • health care professionals
    • must contain adequate information for use (pkg insert)
  41. OTC labeling
    • for consumer
    • must contain adequate directions for use
  42. Most prohibited acts involve
    misbranding or adulteration
  43. Misbranding and adulteration become applicable to pharmacies when
    • receipt and delivery of a/m drug
    • causing a drug to be counterfeit
    • alteration, mutilation of labeling
  44. Class I recall
    issued when product will cause serious ADRs or death
  45. Class II recalls
    • product may cause temporary or medically reversible ADRs
    • serious consequences are remote
  46. Class III recalls
    product is not likely to cause ADEs
  47. Initiation of product recalls
    FDA can request mfg to recall or mandate a recall
Card Set
Law Chapter 2 Part 1
Law Chapter 2 Part 1