Pharm Care/management Test 2 Set 2

Front 1

The Rosenwaike elderly categories (3) (and which is growing fastest)

Back 1

1)young old (65-74)
2)middle old (75-84)
3)old old (85+)***

Front 2

LTC Facilities (types) (7)

Back 2

1)nursing
2)skilled nursing
3)psychiatric hospitals
4)correctional facilities
5)hospice
6)community adult day care
7)assisted living facilities

Front 3

Medicare doesn't pay for...

Back 3

assisted living

Front 4

Home care definition

Back 4

equipment/services to the patient in the home to restore/maintain his or her maximal level of fxn/health

Front 5

Home care industries (3)

Back 5

1)home health services
2)home health infusion therapy
3)home medical equipment

Front 6

____ is a cost effect alternative to hospitalization

Back 6

home infusion therapy

Front 7

Influencing Factors of Home Care...(3)

Back 7

1)reimbursement issues
2)gov't insurances
3)MCO's

Front 8

Pharmacist Role in Home Care (4 of many)

Back 8

1)therapy selection
2)infusion devices
3)drug information
4)packaging

Front 9

Which is a DME? (hospital bed or IV catheter)

Back 9

hospital bed

Front 10

1906 Pure Food and Drugs Act

Back 10

1st law that gave gov't oversight over medicines

Front 11

1914 Harrison Act

Back 11

made most opoids and cocaine illegal

Front 12

1951 Durham-Humphrey Amendment

Back 12

Rx drugs can only be sold w/ a Rx

Front 13

Other important federal drug legislation (4)

Back 13

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)

Front 14

Pure Food and Drug Act of 1906
a)purpose
b)reqd
c)sparked by...
d)only teeth of act is...

Back 14

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

Front 15

Food Drug and Cosmetic Act of 1938
a)driving force for this act
b)power it gave gov't (2)

Back 15

a)1937 sulfanilamide elixir tragedy
b1)FDA has jurisdiction over product safety
b2)reqd safety testing prior to marketing but no efficacy testing

Front 16

Who was the driving force behind exposing the sulfanilamide tragedy?

Back 16

Tulsa MD James Stevenson

Front 17

1937 Sulfanilamide elixir tragedy led to...

Back 17

Food, Drug and Cosmetic Act of 1938

Front 18

1962 Kefauver-Harris Amendment
a)driving force
b)power it gave (3)

Back 18

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

Front 19

Which act gave us the FDA we have today?

Back 19

1962 Kefauver-Harris Amendment

Front 20

DESI (Drug Efficacy Study Implementation) program
a)what are they
b)what they did

Back 20

a)30 panels created to study pre-1962 Rx/OTC drugs
b)6000 products removed from market (600 were Rx)

Front 21

DESI created categories of...and what each meant (4)

Back 21

1)effective (stays out)
2)probably effective (must do additional studies)
3)possibly effective (must do additional studies)
4)Ineffective (removed)

Front 22

If 10,000 drug candidates are studies what happens? (3)

Back 22

1)1,000 tested in animals
2)200 tested in humans
3)1 approved in USA

Front 23

What has thalidomide been approved for? and when?

Back 23

leprosy in 98

Front 24

Acutane is approved for..

Back 24

severe acne

Front 25

1st step in drug approval process

Back 25

File an IND to do ANY research on a new drug, involves pre-clinical evaluation and analysis

Front 26

A Drug IND is filed w/ who?

Back 26

Center for Drug Evaluation and Research

Front 27

Biological INDs are filed w/ who?

Back 27

Center for Biologics Evaluation and Research

Front 28

IND purpose (3)

Back 28

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

Front 29

IND application contents for investigational drugs (6)

Back 29

1)chemistry
2)pharmacology evaluations
3)details of manufacturing
4)results of lab/animal tests
5)initial clinical plan
6)acute/subacute toxicity studies

Front 30

IND application additional requirements (5)

Back 30

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

Front 31

Phase 1 clinical trials
a)# subjects and desc
b)length
c)fxn (6)

Back 31

a)50 healthy adult males
b)12 months
c)SAFETY, ADME, pharmacologic action, tolerance, toxic manifestations, bioavailability

Front 32

Phase 2 clinical trials
a)# subjects and desc
b)length
c)fxn (4)

Back 32

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

Front 33

Phase 3 clinical trials
a)# subjects and desc
b)length
c)fxn (5)

Back 33

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

Front 34

When clinical trials are complete the company submits...and recieves (2)

Back 34

1)New Drug Application (NDA)

1)initial review by 1 of 19 advisory committees to the FDA
2)FDA sends "approvable" or "not approvable"

Front 35

NDA contains...

Back 35

a)all info obatined during IND (eg pharmacology/labeling)

Front 36

After NDA is submitted FDA has...then...(2)

Back 36

60 days to respond, can disapprove or ask for more info

1)NDA reviewed by external panel
2)FDA decision to approve/not approve

Front 37

Recent big blow to Merck

Back 37

Arcoxia was "non-approvable" (follow up to vioxx)

Front 38

Amt of time it takes for FDA approval after clinical trials

Back 38

2months-7years

2mon for chemo/HIV drugs

Front 39

Amt of time it takes to do clinical trials

Back 39

5years

Front 40

Once NDA approved company can market product:

Back 40

Only for approved indication on LABEL (label=package insert)

Front 41

Off-label uses (3)

Back 41

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

Front 42

sNDA?

Back 42

supplemental NDA

Front 43

Prescription Drug User Fee Act (PDUFA) fxn (3)

Back 43

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

Front 44

PDUFA trade off:

Back 44

FDA agrees to speed up review times (timelines)

Front 45

PDUFA user fees are based on... (2)

Back 45

1)how many drug-manufacturing facilities company has
2)number of medicines the company sells in the US

Front 46

Costs about ____ to submit application to FDA

Back 46

$1million

Front 47

Positive impact of Drug legislation on new pharmaceuticals (2)

Back 47

1)enhanced consumer protection
2)consumers now expect safe/effective drugs

Front 48

Negative impact of Drug legislation on new pharmaceuticals (2)

Back 48

1)"drug lag" (review time 32months)
2)cost of R&D to get new product approved is high (359million)

Front 49

The $359million it costs to get a drug approved consists of...

Back 49

costs it takes to get the 1 approved drug and the 99,999 that didnt get approved

Front 50

Newest PDUFA act says... (3)

Back 50

1)FDA has more authority to change label and
2)more power over drugs already approved (recall)
3)increased application fees

Front 51

Current pressure on the FDA regarding "User Fees" (3)

Back 51

1)Have decreased NDA approval times
2)seeing more drug recalls as a result
3)public pressure for FDA to more carefully eval drugs

Front 52

Current pressure on the FDA regarding "Growing sentiment to re-eval approval process" (3)

Back 52

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)

Front 53

Drug companies profit margin;
Any other business profit margin

Back 53

80-90%

30%

Front 54

Reason for Drug Price Competition and Patent Term Restoration Act (WAXMAN/HATCH ACT) and 2 titles fxn

Back 54

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

Front 55

Why extend Patent life on new drugs?

Back 55

If FDA sat on drugs for too long

Front 56

When does patent start on a drug and how long do they last?

Back 56

When drug is FIRST DISCOVERED

17 years

Front 57

Patent life of drugs can be longer than 17 years via...

Back 57

drug having multiple patents (ie patent on manufacture process)

Front 58

Before Waxman/Hatch... (4)

Back 58

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

Front 59

Waxman/Hatch mainly involves what?

Back 59

ANDA (abbreviated new drug application)

Front 60

ANDA (3)

Back 60

1)basis of approval is bioequivalency studies
2)safety and efficacy data are NOT reqd
3)must prove bioequivalence to brand/innovator product

Front 61

NDA includes (7)

Back 61

1)chemistry
2)manufacturing
3)controls
4)labeling
5)testing
6)preclinical/clinical studies***
7)bioavailability***

Front 62

ANDA includes (6)

Back 62

1)chemistry
2)manufacturing
3)controls
4)labeling
5)testing
6)bioequivalence**

Front 63

Bioequivalence studies

Back 63

Brand/innovator's formulation vs. generic in 18-24yo healthy males and take blood samples over 24 hours period

Front 64

Bioequivalence studies evaluate (4)

Back 64

1)AUC
2)half-life
3)time to peak plasma []
4)value of peak plasma []

Front 65

Allowed statistical variability in bioequivalence (and usual variability)

Back 65

+/- 20%

usually +/- 3%

Front 66

FDA's criteria for equivalence (5)

Back 66

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

Front 67

Pharmaceutical equivalents? (3)

Back 67

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

Front 68

FDA's criteria for bioequivalent (2 its a 1 or the other type of thing)

Back 68

1)do NOT present a known or potential bioequivalence problem and they meet an IN VITRO bioequivalence standard
or
2)if they do present such a known or potential problem, they meet an IN VIVO bioequivalence standard

Front 69

Bioequivalence has been tough for....(3 drugs and why)

Back 69

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

Front 70

Bioequivalence def.

Back 70

2 products have the same peak [] of drug in plasma and the same AUC

Front 71

"A" drug products (A equivalents)

Back 71

FDA considers equivalent AA, AN, AO, AP, AT, AB

Front 72

Codes that have NO known or suspected bioequivalence products

Back 72

AA- capsule, tablets, liquid
AN- aerosol
AO- injectable oil
AP- injectable aqueous
AT- topical

Front 73

Codes w/ actual or potential bioeq probs have been resolved w/ adequate VIVO/VITRO tests

Back 73

AB

Front 74

AB rated generics are... (7)

Back 74

1)Identical AIs
2)dosage form
3)ROA
4)strength
5)bioequivalence
6)GMP's
7)comparable labeling

Front 75

"B" drug products (B equivalents) (3)

Back 75

1)drugs that FDA considers NOT equivalent
2)bioequivalence problems have not been resolved (problem often w/ dosage form)
3)BC,BD,BE,BN,BP,BR,BX

Front 76

Waxman/Hatch Title II (3)

Back 76

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

Front 77

Common mental illness risk factors (7 in 3 categories)

Back 77

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)

Front 78

Why is primary prevention of mental illness so hard?

Back 78

psychiatric illness's nature is too complex to catch at the primary level

Front 79

Controversy in PSYCHIATRIC INSURANCE COVERAGE (5)

Back 79

1)inconsistent
2)less comprehensive
3)characterized by limitations
3a)caps on total coverage available
3b)higher coinsurance & deductibles

Front 80

Controversy in MANAGED CARE COVERAGE (4)

Back 80

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

Front 81

Mentally ill are easy targets for MCO's via...(4)

Back 81

1)reduction chemical dependency programs
2)preference of meds vs. psychotherapy
3)lack of providers
4)diagnosis used for coverage

Front 82

Most common mental disorders in men 18-64 (2)

Back 82

1)alcohol abuse/dependency
2)antisocial personality

Front 83

Most common mental disorders in women 25-44 (3)

Back 83

1)somatization
2)OCD
3)depression

Front 84

Most common mental disorders in unemployed (3)

Back 84

1)higher rates of mania
2)schizophrenia
3)panic disorders

Front 85

Most common mental disorders in unmarried (3)

Back 85

1)higher rates of drug abuse
2)mania
3)antisocial

Front 86

More mental illness experienced in...

Back 86

men than women (36% vs. 30%)

Front 87

Development of current mental illness system started w/...and why

Back 87

National Mental Health Act of 1946 due to returning WW2 vets

Front 88

5 basic mental services were created by... (and the services)

Back 88

1)inpatient
2)outpatient
3)emergency
4)day treatment
5)consultation

Mental Retardation Facilities and Community Mental Health Center Construction Act of 1964

Front 89

1965 Medicare/Medicaid for mental illness did what? (2)

Back 89

1)depopulate mental hospitals
2)move to LTC facilities

Front 90

Factors affecting compliance in mentally ill? (3)

Back 90

1)different providers
2)polypharmacy = complicated schedules
3)this population is particularly at risk

Front 91

Health insurance purpose

Back 91

aid ppl and business in managing unanticipated risk

Front 92

Anticipated risk is NOT insurable (3 ex)

Back 92

1)gambling
2)depreciation
3)food spoilage

Front 93

Pure risk
a)def (2)
b)ex (4)

Back 93

a1)face possibility of loss but NO gain
a2)transfers risk from person to insurance company
b)illness, fire, storms, theft

Front 94

Speculative risk
a)def
b)ex (2)

Back 94

a)can NOT insure this (have chance for gain and loss)
b)gambling, business venture

Front 95

Insurable hazard's are:*** (7)

Back 95

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

Front 96

Risk Management problems (3)

Back 96

1)catastrophic hazard
2)adverse selection
3)incentives

Front 97

Catastrophic hazard?

Back 97

events that exceed company's ability to pay

Front 98

Adverse Selection?

Back 98

Ppl purchase only when expecting a loss (old, sick)

Front 99

Incentives? (2)

Back 99

1)supplier induced demand
2)patient induced demand (over consume b/c have insurance)

Front 100

Why do ppl spend more on health via insurance in Dec than January?

Back 100

trying to meet deductible