-
What is Pure Food and Drug of 1906
Prohibits interstate transport or sale of adulterated and misbranded food or drugs
-
What is Food, Drug, & Cosmetic of 1938
Created FDA, required that all new drug applications be filed with FDA & defined adulteration and misbranding
-
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
-
What is Kefauver-harris of 1962
requires all drugs to be safe, pure & effective
-
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.
-
what is schedule I
no accepted medical use, extremely high potential for abuse
-
what is schedule II
has medical use, high abuse potential
-
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
-
What is poison prevention packaging of 1970
most OTC & legend drugs must be packaged in child resistant containers
-
what is osha (occupational safety and hazardous act) of 1970
healthful workplace
-
NDC
- first five = manufacturer
- next four = drug product
- last 2 = package size
-
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
-
weight apothecary
- 20 grams = 1 scruple
- 3 scruples = 1 dram
- 8 drams = 1 oz
- 16 oz = 1 lb
-
volume apothecary
- 60 minims = 1 fl dram
- 8 fl dram = 1 fl oz
- 16 fl oz = 1 pt
1 grain = 60 mg
-
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
-
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
-
Temperature conversion
F= (CX1.8)+32
C= (F-32)/1.8
-
What is AWP
Average whole price = AWP+/_ percentage + dispensing fee, form of reimbursement to pharmacy
-
what is mac
maximum allowable cost = max cost insurance will pay for generic drugs
-
what is aac
actual acquisition cost = price pharmacy paid
-
Dilution problem
- initial volume (iv) x initial strength (is) =
- final volume (fv) x final strength (fs)
-
powder volume
- final volume - diluent volume
- used in constitution for reconstituting a solution
-
DEA forms
222 = order schedule II's
224 = register a pharmacy
106 = theft of
41 = destruction of
-
Specific gravity
- wt of substance/wt of an equal volume of water
- (water has a specific gravity of 1)
-
clark's rule
wt of child(lb)/150xadult dose = child dose
-
young's rule
age in years of child (+12)/age x adult dose
or
months x dose / 150
-
bsa in metric
height (cm) x weight (kg) / 3600 = ? then square root that #
-
bsa standard
height (inches) x weight (lbs) / 3131 = ? then square root
-
find child dose w/BSA
BSA m2(answer from using BSA metric or standard) / 1.73 x adult dose
-
what is a deductible
set amt that must b/paid by the patient
-
Book provides info on drug prices
drug topics red book
-
container impervious to air under normal handling, shipment, storage & distribution
hermetic
-
number given by manuf. to identify a particular batch of medicine
lot number
-
aquaphor is
an absorption ointment base
-
potentiation is
drug interaction that occurs when one drug increases or prolongs the effect of another drug
-
pump used as a pca
cadd prizm pcs pump
-
emulsions are
dosage form that can be prepared by the dry gum method, wet gum method, or beaker method
-
Center for medicare services
organization that oversees medicare and Medicaid services
-
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)
-
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
-
poison prevention packaging act of 1970:
most OTC and legend drugs be packaged in child resistant containers
-
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
-
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
-
orphan drug act of 1983:
meds for the tx of diseases or conditions that are fewer than 200,000 cases in the world
-
drug price competition & patent term restoration act of 1984:
encouraged creation of both generic & new meds
-
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
-
omnibus budget reconciliation act of 1987:
established extensive revisions to medicare and Medicaid conditions of participation regarding LTC facilities and pharmacy
-
omnibus budget reconciliation act of 1990:
manuf. provide the lowest prices to any customer or Medicaid patient, requires offer to counsel
-
fda safe medical devices act of 1990:
all medical devices be tracked & records be maintained
-
amer. w/disabilities act of 1990:
prevents discrimination against potential employees who may possess a disability
-
resource conservation & recovery act:
guidelines regarding the disposal of hazardous waste, flushing is no longer acceptable
-
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
-
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
-
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
-
any willing provider law:
allows any pharmacy to participate in a prescription drug benefit plan as long as agree to terms & conditions
-
freedom of choice law:
mbr of a prescription drug plan to select any pharmacy for his/her pharmacy benefits
-
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
-
prescription drug equity law:
prohibit a script drug plan from requiring mail order prescription drug coverage w/out also providing non-mail order coverage
-
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
-
combat methamphetamine epidemic act of 2005:
placed ephedrine, pseudoephedrine & phenylpropanolamine in the controlled substances act
-
Medicaid tamper resistant prescription act:
applies to all handwritten prescriptions
-
bureau of alcohol, tobacco, & firearms:
sets regulations regarding purchase of tax free alcohol, tax free alcohol may be used in hospitals and clinics
-
centers for medicare & Medicaid services:
establishes conditions for a facility to be reimbursed for services rendered
-
drug enforcement agency:
enforces compliance w/the controlled substances act, overseen by the dept of justice
-
environmental protection agency:
sets guidelines for the disposal of hazardous waste
-
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
-
institutional review board:
a board designated by an institution to approve biomedical research
-
the joint commission:
addresses quality of patient care & safety, establishes standards & accredits various health care providers
-
Nat'l assoc of the boards of pharmacy:
has no regulatory authority but meets to discuss current trends & issues in pharmacy
-
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
-
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
-
Lot numbers
assigned by manufacturer to identify a given batch of meds; expiration dates assigned by manufacturer
-
X=10
L=50
C=100
D=500
M=1000
-
TPN:
contains 50% dextrose, 10% amino acids, 20% fat
-
peripheral parenteral nutrition:
25% dextrose, 10% amino acids, 10% fat & is short term therapy
-
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
-
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
-
Dispersions:
suspensions (oral, topical, injectable), emulsion (w/o, o/w), lotion, gel, ointment, pastes, creams
-
inhalants:
aerosol, spray
-
transdermal products:
delivers a controlled dose thru the skin & absorbed in bloodstream
-
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
-
pharmacy & therapeutics committee:
committee composed of pharmacists, physicians, nurses, pharmacy buyers, & accountants who develop a formulary for a hospital
-
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
-
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
-
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
-
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
-
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
|
|
