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100 Cards in this Set

  • Front
  • Back
The Rosenwaike elderly categories (3) (and which is growing fastest)
1)young old (65-74)
2)middle old (75-84)
3)old old (85+)***
LTC Facilities (types) (7)
2)skilled nursing
3)psychiatric hospitals
4)correctional facilities
6)community adult day care
7)assisted living facilities
Medicare doesn't pay for...
assisted living
Home care definition
equipment/services to the patient in the home to restore/maintain his or her maximal level of fxn/health
Home care industries (3)
1)home health services
2)home health infusion therapy
3)home medical equipment
____ is a cost effect alternative to hospitalization
home infusion therapy
Influencing Factors of Home Care...(3)
1)reimbursement issues
2)gov't insurances
Pharmacist Role in Home Care (4 of many)
1)therapy selection
2)infusion devices
3)drug information
Which is a DME? (hospital bed or IV catheter)
hospital bed
1906 Pure Food and Drugs Act
1st law that gave gov't oversight over medicines
1914 Harrison Act
made most opoids and cocaine illegal
1951 Durham-Humphrey Amendment
Rx drugs can only be sold w/ a Rx
Other important federal drug legislation (4)
1)Food, Drug, Comsmetic Act
2)Kefauver Harris Amendment
3)Drug Price Competition and Patent Term Resoration Act (Waxman)
4)Rx Drug User Fee Act (PDUFA)
Pure Food and Drug Act of 1906
c)sparked by...
d)only teeth of act is...
a)prohibit the adulteration and misbranding of food and patent medicines
b)ID and composition to be listed on label (BUT STILL CAN MAKE CRAZY CLAIMS)
c)"The Jungle", Muckrakers
d)labeling of ingredients must be correct
Food Drug and Cosmetic Act of 1938
a)driving force for this act
b)power it gave gov't (2)
a)1937 sulfanilamide elixir tragedy
b1)FDA has jurisdiction over product safety
b2)reqd safety testing prior to marketing but no efficacy testing
Who was the driving force behind exposing the sulfanilamide tragedy?
Tulsa MD James Stevenson
1937 Sulfanilamide elixir tragedy led to...
Food, Drug and Cosmetic Act of 1938
1962 Kefauver-Harris Amendment
a)driving force
b)power it gave (3)
a)thalidomide diaster in Europe (Sen. Kefauver had thalidomide baby on front page of paper)
b1)efficacy must be shown in US
b2)FDA involved in pre-clinical testing
b3)SE's and CI's must be said in drug promotion
Which act gave us the FDA we have today?
1962 Kefauver-Harris Amendment
DESI (Drug Efficacy Study Implementation) program
a)what are they
b)what they did
a)30 panels created to study pre-1962 Rx/OTC drugs
b)6000 products removed from market (600 were Rx)
DESI created categories of...and what each meant (4)
1)effective (stays out)
2)probably effective (must do additional studies)
3)possibly effective (must do additional studies)
4)Ineffective (removed)
If 10,000 drug candidates are studies what happens? (3)
1)1,000 tested in animals
2)200 tested in humans
3)1 approved in USA
What has thalidomide been approved for? and when?
leprosy in 98
Acutane is approved for..
severe acne
1st step in drug approval process
File an IND to do ANY research on a new drug, involves pre-clinical evaluation and analysis
A Drug IND is filed w/ who?
Center for Drug Evaluation and Research
Biological INDs are filed w/ who?
Center for Biologics Evaluation and Research
IND purpose (3)
1)gives govt opportunity to ID and ban experimental drugs posing a risk to humans
2)mechanism to monitor clinical investigators and protect rights of subjects
3)lets FDA to examine studies to determine if drug has proper safety and efficacy
IND application contents for investigational drugs (6)
2)pharmacology evaluations
3)details of manufacturing
4)results of lab/animal tests
5)initial clinical plan
6)acute/subacute toxicity studies
IND application additional requirements (5)
1)qualifications of clinical investigators
2)must notify FDA if product studies are discontinued
3)30day delay before you can do clinical studies
4)avoid commercialization
5)environmental impact analysis
Phase 1 clinical trials
a)# subjects and desc
c)fxn (6)
a)50 healthy adult males
b)12 months
c)SAFETY, ADME, pharmacologic action, tolerance, toxic manifestations, bioavailability
Phase 2 clinical trials
a)# subjects and desc
c)fxn (4)
a)100-200 males and females w/ disease for which drug is intended
b)12 months
c)well-controlled trials (w/ placebo), dose-response, EFFICACY, adverse rxns
Phase 3 clinical trials
a)# subjects and desc
c)fxn (5)
a)800 patients @ multi places
b)12 months
c)continue to assess safety & efficacy, use marketed dosage form, interactions, special populations, effects liver/kidney disease
When clinical trials are complete the company submits...and recieves (2)
1)New Drug Application (NDA)

1)initial review by 1 of 19 advisory committees to the FDA
2)FDA sends "approvable" or "not approvable"
NDA contains...
a)all info obatined during IND (eg pharmacology/labeling)
After NDA is submitted FDA has...then...(2)
60 days to respond, can disapprove or ask for more info

1)NDA reviewed by external panel
2)FDA decision to approve/not approve
Recent big blow to Merck
Arcoxia was "non-approvable" (follow up to vioxx)
Amt of time it takes for FDA approval after clinical trials

2mon for chemo/HIV drugs
Amt of time it takes to do clinical trials
Once NDA approved company can market product:
Only for approved indication on LABEL (label=package insert)
Off-label uses (3)
1)not mentioned in package insert
2)prescriber can prescribe for any indication
3)comany must submit sNDA if wanting to market for an off-label use
supplemental NDA
Prescription Drug User Fee Act (PDUFA) fxn (3)
1)Lets FDA collect fees from companies that produce drugs
2)submit fee in addition to appliction for review process
3)prior to this all FDA review work paid by taxpayers
PDUFA trade off:
FDA agrees to speed up review times (timelines)
PDUFA user fees are based on... (2)
1)how many drug-manufacturing facilities company has
2)number of medicines the company sells in the US
Costs about ____ to submit application to FDA
Positive impact of Drug legislation on new pharmaceuticals (2)
1)enhanced consumer protection
2)consumers now expect safe/effective drugs
Negative impact of Drug legislation on new pharmaceuticals (2)
1)"drug lag" (review time 32months)
2)cost of R&D to get new product approved is high (359million)
The $359million it costs to get a drug approved consists of...
costs it takes to get the 1 approved drug and the 99,999 that didnt get approved
Newest PDUFA act says... (3)
1)FDA has more authority to change label and
2)more power over drugs already approved (recall)
3)increased application fees
Current pressure on the FDA regarding "User Fees" (3)
1)Have decreased NDA approval times
2)seeing more drug recalls as a result
3)public pressure for FDA to more carefully eval drugs
Current pressure on the FDA regarding "Growing sentiment to re-eval approval process" (3)
1)use of reference drug against new drug should be in approval process
2)mandatory phase 4 for all drugs
3)cancer treatment denial (ppl dying of cancer should get access to all new chemo drugs)
Drug companies profit margin;
Any other business profit margin

Reason for Drug Price Competition and Patent Term Restoration Act (WAXMAN/HATCH ACT) and 2 titles fxn
reason)needed method for FDA approval of post-1962 generic drugs
TitleI)procedure for FDA approval of generic drugs
TitleII)procedure for incr the effective patent life for new drugs
Why extend Patent life on new drugs?
If FDA sat on drugs for too long
When does patent start on a drug and how long do they last?

17 years
Patent life of drugs can be longer than 17 years via...
drug having multiple patents (ie patent on manufacture process)
Before Waxman/Hatch... (4)
1)brand name drugs dominant/profitable long after patent expired
2)difficult to approve new generics
3)low public confidence in generics
4)regulatory process reduced the true market exclusively period for new products
Waxman/Hatch mainly involves what?
ANDA (abbreviated new drug application)
ANDA (3)
1)basis of approval is bioequivalency studies
2)safety and efficacy data are NOT reqd
3)must prove bioequivalence to brand/innovator product
NDA includes (7)
6)preclinical/clinical studies***
ANDA includes (6)
Bioequivalence studies
Brand/innovator's formulation vs. generic in 18-24yo healthy males and take blood samples over 24 hours period
Bioequivalence studies evaluate (4)
3)time to peak plasma []
4)value of peak plasma []
Allowed statistical variability in bioequivalence (and usual variability)
+/- 20%

usually +/- 3%
FDA's criteria for equivalence (5)
1)approved as both safe and effective
2)they are pharmaceutical equivalents
3)they are bioequivalent
4)they are adequately labeled
5)they are manufactured in compliance w/ FDA's good manufacturing practices
Pharmaceutical equivalents? (3)
1)contain identical amount of same AIs in the same dosage form and ROA
2)meets standards of strength, quality, purity, identity
3)excepients do NOT have to be the same
FDA's criteria for bioequivalent (2 its a 1 or the other type of thing)
1)do NOT present a known or potential bioequivalence problem and they meet an IN VITRO bioequivalence standard
2)if they do present such a known or potential problem, they meet an IN VIVO bioequivalence standard
Bioequivalence has been tough for....(3 drugs and why)
1)premarin b/c we make estrogen endogenously
2)carafate b/c not absorbed
3)dyazide- generic co's couldn't make bioavailability as bad as brand's
Bioequivalence def.
2 products have the same peak [] of drug in plasma and the same AUC
"A" drug products (A equivalents)
FDA considers equivalent AA, AN, AO, AP, AT, AB
Codes that have NO known or suspected bioequivalence products
AA- capsule, tablets, liquid
AN- aerosol
AO- injectable oil
AP- injectable aqueous
AT- topical
Codes w/ actual or potential bioeq probs have been resolved w/ adequate VIVO/VITRO tests
AB rated generics are... (7)
1)Identical AIs
2)dosage form
7)comparable labeling
"B" drug products (B equivalents) (3)
1)drugs that FDA considers NOT equivalent
2)bioequivalence problems have not been resolved (problem often w/ dosage form)
Waxman/Hatch Title II (3)
1)increase effective patent life for pioneer new drugs
2)up to 5 year extension of original patent if FDA was slow
3)max 14 year marketable patent life
Common mental illness risk factors (7 in 3 categories)
1)personal like chronic physical illness
2)environmental like low socioeconomic status and other community variables
3)Family (paternal criminality, maternal mental disorders, overcrowding/family size)
Why is primary prevention of mental illness so hard?
psychiatric illness's nature is too complex to catch at the primary level
2)less comprehensive
3)characterized by limitations
3a)caps on total coverage available
3b)higher coinsurance & deductibles
Controversy in MANAGED CARE COVERAGE (4)
1)impairment decrease self-advocacy
2)programs may be limited to EAP
3)Cultural/socioeconomic status issues may not be addressed
4)easy targets for MCO's
Mentally ill are easy targets for MCO's via...(4)
1)reduction chemical dependency programs
2)preference of meds vs. psychotherapy
3)lack of providers
4)diagnosis used for coverage
Most common mental disorders in men 18-64 (2)
1)alcohol abuse/dependency
2)antisocial personality
Most common mental disorders in women 25-44 (3)
Most common mental disorders in unemployed (3)
1)higher rates of mania
3)panic disorders
Most common mental disorders in unmarried (3)
1)higher rates of drug abuse
More mental illness experienced in...
men than women (36% vs. 30%)
Development of current mental illness system started w/...and why
National Mental Health Act of 1946 due to returning WW2 vets
5 basic mental services were created by... (and the services)
4)day treatment

Mental Retardation Facilities and Community Mental Health Center Construction Act of 1964
1965 Medicare/Medicaid for mental illness did what? (2)
1)depopulate mental hospitals
2)move to LTC facilities
Factors affecting compliance in mentally ill? (3)
1)different providers
2)polypharmacy = complicated schedules
3)this population is particularly at risk
Health insurance purpose
aid ppl and business in managing unanticipated risk
Anticipated risk is NOT insurable (3 ex)
3)food spoilage
Pure risk
a)def (2)
b)ex (4)
a1)face possibility of loss but NO gain
a2)transfers risk from person to insurance company
b)illness, fire, storms, theft
Speculative risk
b)ex (2)
a)can NOT insure this (have chance for gain and loss)
b)gambling, business venture
Insurable hazard's are:*** (7)
1)probability of peril occurring in a population can be accurately determined
2)peril is irregular event on individual basis
3)loss must be accidental
4)event must result in substantial loss
5)loss must be measurable
6)individual must have an insurable interest
7)individual must suffer loss personally
Risk Management problems (3)
1)catastrophic hazard
2)adverse selection
Catastrophic hazard?
events that exceed company's ability to pay
Adverse Selection?
Ppl purchase only when expecting a loss (old, sick)
Incentives? (2)
1)supplier induced demand
2)patient induced demand (over consume b/c have insurance)
Why do ppl spend more on health via insurance in Dec than January?
trying to meet deductible