PTCB Study Guide

  1. What is Pure Food and Drug of 1906
    Prohibits interstate transport or sale of adulterated and misbranded food or drugs
  2. What is Food, Drug, & Cosmetic of 1938
    Created FDA, required that all new drug applications be filed with FDA & defined adulteration and misbranding
  3. What is Durham-Humphrey of 1951
    requires all products to have adequate directions for use, separated drugs into legend and OTC (non-legend), allows verbal & refill scripts over the phone
  4. What is Kefauver-harris of 1962
    requires all drugs to be safe, pure & effective
  5. what is comprehensive drug abuse prevention & control act of 1970
    created DEA & placed under Dept of Justice, controlled subs placed in 1 of 5 cat.
  6. what is schedule I
    no accepted medical use, extremely high potential for abuse
  7. what is schedule II
    has medical use, high abuse potential
  8. what is schedule III thru V
    • III = accepted medical use, abuse potential less
    • IV = abuse potential less than III, but may lead to limited physical/psychological dependence
    • V = abuse potential less
  9. What is poison prevention packaging of 1970
    most OTC & legend drugs must be packaged in child resistant containers
  10. what is osha (occupational safety and hazardous act) of 1970
    healthful workplace
  11. NDC
    • first five = manufacturer
    • next four = drug product
    • last 2 = package size
  12. Volume
    • 5ml = 1 tsp
    • 3 tsp = 1 tbsp
    • 2 tbsp. = 1 fl oz
    • 8 fl oz = 1 c
    • 2 c = 1 pt
    • 2 pt = 1 qt
    • 4 qt = 1 gal
  13. weight apothecary
    • 20 grams = 1 scruple
    • 3 scruples = 1 dram
    • 8 drams = 1 oz
    • 16 oz = 1 lb
  14. volume apothecary
    • 60 minims = 1 fl dram
    • 8 fl dram = 1 fl oz
    • 16 fl oz = 1 pt

    1 grain = 60 mg
  15. to convert
    • decimal to % = multiply # by 100
    • % to decimal = divide by 100
    • fraction to % = divide numerator by denominator, then multiply by 100
    • % to fraction = place over 100 & reduce
    • ratio to % divide 1st # by 2nd, x100
  16. DEA #
    A, B, F, or M & 2nd letter is last name initial

    • add 1st, 3rd, & 5th #
    • add 2nd, 4th, & 6th # x2
    • Add both together, last number = 7th # in DEA
  17. Temperature conversion
    F= (CX1.8)+32

    C= (F-32)/1.8
  18. What is AWP
    Average whole price = AWP+/_ percentage + dispensing fee, form of reimbursement to pharmacy
  19. what is mac
    maximum allowable cost = max cost insurance will pay for generic drugs
  20. what is aac
    actual acquisition cost = price pharmacy paid
  21. Dilution problem
    • initial volume (iv) x initial strength (is) =
    • final volume (fv) x final strength (fs)
  22. powder volume
    • final volume - diluent volume
    • used in constitution for reconstituting a solution
  23. DEA forms
    222 = order schedule II's

    224 = register a pharmacy

    106 = theft of

    41 = destruction of
  24. Specific gravity
    • wt of substance/wt of an equal volume of water
    • (water has a specific gravity of 1)
  25. clark's rule
    wt of child(lb)/150xadult dose = child dose
  26. young's rule
    age in years of child (+12)/age x adult dose


    months x dose / 150
  27. bsa in metric
    height (cm) x weight (kg) / 3600 = ? then square root that #
  28. bsa standard
    height (inches) x weight (lbs) / 3131 = ? then square root
  29. find child dose w/BSA
    BSA m2(answer from using BSA metric or standard) / 1.73 x adult dose
  30. what is a deductible
    set amt that must b/paid by the patient
  31. Book provides info on drug prices
    drug topics red book
  32. container impervious to air under normal handling, shipment, storage & distribution
  33. number given by manuf. to identify a particular batch of medicine
    lot number
  34. aquaphor is
    an absorption ointment base
  35. potentiation is
    drug interaction that occurs when one drug increases or prolongs the effect of another drug
  36. pump used as a pca
    cadd prizm pcs pump
  37. emulsions are
    dosage form that can be prepared by the dry gum method, wet gum method, or beaker method
  38. Center for medicare services
    organization that oversees medicare and Medicaid services
  39. proper storage conditions
    • cold=nte 8*C (46*F)
    • cool=btwn 8* & 15* (46* to 59*F)
    • room temp=btwn 15 & 30*C (59 & 86*F)
    • warm=30 & 40*C (86 & 104*F)
    • excessive heat= above 40*C (104*F)
  40. DEA allows transfer of the original script for schedule II, III, IV, & V controlled substances for the purpose of refill dispensing btwn pharmacies on a one time basis
  41. poison prevention packaging act of 1970:
    most OTC and legend drugs be packaged in child resistant containers
  42. occupational safety & health act of 1970:
    ensures a safe and healthful workplace for all employees, requires use of MSDS which are provided by the seller of a particular product to the purchaser
  43. drug listing act of 1972:
    each drug assigned 11 digit number to identify it (NDC)
    1st 5 = manufacturer
    2nd 4=drug product
    last 2=package size and packaging
  44. orphan drug act of 1983:
    meds for the tx of diseases or conditions that are fewer than 200,000 cases in the world
  45. drug price competition & patent term restoration act of 1984:
    encouraged creation of both generic & new meds
  46. prescription drug marketing act of 1987:
    prohibits the reimportation of a drug into the US by anyone except manuf, prohibits sale or distribution of samples to anyone other than those licensed to prescribe them
  47. omnibus budget reconciliation act of 1987:
    established extensive revisions to medicare and Medicaid conditions of participation regarding LTC facilities and pharmacy
  48. omnibus budget reconciliation act of 1990:
    manuf. provide the lowest prices to any customer or Medicaid patient, requires offer to counsel
  49. fda safe medical devices act of 1990:
    all medical devices be tracked & records be maintained
  50. amer. w/disabilities act of 1990:
    prevents discrimination against potential employees who may possess a disability
  51. resource conservation & recovery act:
    guidelines regarding the disposal of hazardous waste, flushing is no longer acceptable
  52. dietary supplement health & education act of 1994
    herbal products are dietary supplements & must be labeled as such, label must have:all ingredients & quantity of ea, list plant(s) derived, meet quality, purity and compositional specification
  53. health insurance portability & accountability act of 1996:
    improve portability & continuity of health coverage in the group & individual markets, combat waste, fraud & abuse in health insurance & health care delivery.
    Title I: insurance reform-protects health insurance coverage for people when changing or loss of a job
    Title II: administrative simplification-established electronic transaction & code set standards
  54. isotretinoin safety & risk mgmnt act of 2004:
    isotretinoin (Accutane) is a very powerful meds used to treat acne, causes severe birth defects, induce abortions, produce adverse psychiatric effects
  55. any willing provider law:
    allows any pharmacy to participate in a prescription drug benefit plan as long as agree to terms & conditions
  56. freedom of choice law:
    mbr of a prescription drug plan to select any pharmacy for his/her pharmacy benefits
  57. freedom of choice w/regard to LTC:
    residents may choose an outside pharmacy for their meds if the pharmaceutical service is not provided under their contract
  58. prescription drug equity law:
    prohibit a script drug plan from requiring mail order prescription drug coverage w/out also providing non-mail order coverage
  59. medicare drug, improvement & modernization act of 2003:
    voluntary script drug benefit to medicare beneficiaries, preventive medical benefits, lowers the reimbursement rates, created a Nat'l competitive bidding program, changed how medicare pays for outpatient part b drugs, voluntary medicare approved discount card program, medicare part d allows those to enroll in either regional or Nat'l insurance plans
  60. combat methamphetamine epidemic act of 2005:
    placed ephedrine, pseudoephedrine & phenylpropanolamine in the controlled substances act
  61. Medicaid tamper resistant prescription act:
    applies to all handwritten prescriptions
  62. bureau of alcohol, tobacco, & firearms:
    sets regulations regarding purchase of tax free alcohol, tax free alcohol may be used in hospitals and clinics
  63. centers for medicare & Medicaid services:
    establishes conditions for a facility to be reimbursed for services rendered
  64. drug enforcement agency:
    enforces compliance w/the controlled substances act, overseen by the dept of justice
  65. environmental protection agency:
    sets guidelines for the disposal of hazardous waste
  66. food & drug administration:
    reviews information supplied on med watch forms, can issue drug recalls, ensures all products are pure, safe, & effective, regulates the distribution of package inserts, reviews new drug applications & investigational new drug applications
  67. institutional review board:
    a board designated by an institution to approve biomedical research
  68. the joint commission:
    addresses quality of patient care & safety, establishes standards & accredits various health care providers
  69. Nat'l assoc of the boards of pharmacy:
    has no regulatory authority but meets to discuss current trends & issues in pharmacy
  70. state board of pharmacy
    oversees the practice of pharmacy in a given state, defines regulations affecting pharmacy, & the roles, duties, & expectations of pharmacists & techs, ability to discipline for improper behavior
  71. united states pharmacopeia:
    set authority for all scripts & OTC meds & other health care products, sets standards for food ingredients and dietary supplements, quality, purity, strength, & consistency of these products
  72. Lot numbers
    assigned by manufacturer to identify a given batch of meds; expiration dates assigned by manufacturer
  73. X=10
  74. TPN:
    contains 50% dextrose, 10% amino acids, 20% fat
  75. peripheral parenteral nutrition:
    25% dextrose, 10% amino acids, 10% fat & is short term therapy
  76. advantages of liquids:
    effective more quickly
    easier to swallow
    convenience of administration, uniformity and flexibility of dosage form, doesn't cause gastrointestinal distress
    • disadvantages of liquid:
    • deterioration, loss of potency, require special sweetening or flavoring, incompatibilities of dissolved substances, may require preservatives, inaccurate measuring, bulkier to carry, interactions may develop
  77. solutions:
    aromatic waters, collodion (topical, contains pyroxylin, dissolved in alcohol & ether), elixir (hydroalcoholic, contains water & alcohol), enema, extract, douche, isotonic, liniments (alcoholic or aleaginous, applied thru rubbing), spirits (alcoholic or hydroalcoholic), syrups (contains sucrose), tinctures
  78. Dispersions:
    suspensions (oral, topical, injectable), emulsion (w/o, o/w), lotion, gel, ointment, pastes, creams
  79. inhalants:
    aerosol, spray
  80. transdermal products:
    delivers a controlled dose thru the skin & absorbed in bloodstream
  81. formulary:
    list of drugs approved for use in an institution
    Open formulary: all pharmaceutical products are carried
    Closed formulary: limited # of products of ea drug classification covered
    restricted formulary: hybrid of both
  82. pharmacy & therapeutics committee:
    committee composed of pharmacists, physicians, nurses, pharmacy buyers, & accountants who develop a formulary for a hospital
  83. third party managed care provider:
    a provider that may develop a formulary for its mbrs regarding products covered for reimbursement, referred to as pharmacy benefit providers
  84. par value (periodic automatic replacement): the amt of drug that is automatically reordered
    minimum & maximum: a predetermined # that states the minimum & max amt of med to be kept on a shelf
  85. federal law mandates that the expiration date cannot exceed 6 months & cannot exceed 25% of the remaining time on the manufacturer's original expiration date on the bulk container
  86. 80/20 rule: 80% of pharmacys drug cost are derived from 20% of drugs carried
    ABC analysis: method to identify & define inventory items based on their usuage
    compliance report: report on all items that were not purchased on bid
    inventory turnover rate: evaluates inventory $$. total annual purchase/inventory value. 12 turns per year is considered good
  87. FDA classifications of recalls
    class I: will cause/lead to serious adverse hlth events/death
    class II: probability will cause adverse hlth events that r/temporary/medically reversible
    class III: will probably not cause adverse hlth event
Card Set
PTCB Study Guide