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Pharmacy Technician University > Law and Ethics > Flashcards

Law and Ethics Flashcards

1
Q

pure food and drug act of 1906

A

label drugs with truthful information

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2
Q

harrison narcotics tax act of 1914

A

stop recreational use of opium

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3
Q

food drug and cosmetic act of 1938 (2)

A

banned misbranding/false claims
established the pharmacopeia (USP) and national formulary for strength, purity, quality of drug

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4
Q

durham-humphrey amendment of 1951

A

required prescriptions for drugs (vs OTC meds)
label caution, prohibits dispensing without prescription

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5
Q

kefauver-harris amendment of 1962 (2)

A

gave FDA authority to approve/reject manufacturer’s marketing applications
forced manufacturers to provide evidence & efficacy thru scientific studies

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6
Q

poison prevention packaging act of 1970

A

all containers have childproof packaging

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7
Q

drug listing act

A

implemented the national code number (NDC)

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8
Q

medical device amendment of 1976

A

establishes 3 classes of medical device, 3 being the most risk and 1 being low risk

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9
Q

orphan drug act f 1983

A

help development of rare diseases

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10
Q

drug price competition and patent term restoration act of 1984

A

encourages manufacturing of generic drugs

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11
Q

prescription drug marketing act of 1987

A

prevent counterfeit (misbranded, subpar, expired prescriptions) drugs

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12
Q

FDA safe medical devices act

A

medical device reporting (MDR) of medical device incidents

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13
Q

anabolic steroids control act of 1990

A

control steroid use as c3 drug

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14
Q

dietary supplement health and education act of 1994

A

regulates supplements

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15
Q

health insurance portability and accountability act (HIPPA) of 1996

A

-established protected health info (PHI) - includes payment for healthcare that identifies individual
-National Provider Identifier (NPI) is assigned to practitioners

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16
Q

what are the HIPPA violation tiers

A

first - breached unknowingly
second - knew violation but did not willfully neglect
third - willfully neglected but attempted to correct problem in 30 days
fourth - willfully neglected and did not correct

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17
Q

medicare prescription drug improvement and modernization act of 2003

A

prescription discount card for low income patients

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18
Q

dietary supplement and nonprescription drug act of 2006

A

requires reporting of adverse events caused by supplements and nonprescription drugs

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19
Q

patient protection and affordable care act of 2010

A

increased affordability of healthcare

some include:
dependents can remain on parent insurance until 26
prohibit lifetime limits on benefits such as hospital stays
plans must cover screening and preventative care

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20
Q

drug quality and security act of 2013

A

electronic tracking system to identify and trace prescription drugs

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21
Q

state board of pharmacy (BOP) vs national association of boards of pharmacy (NABP)

A

BOP = enforce pharmacy law & public health
NABP = assists BOP by building standards; licensing of pharmacists and PTs

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22
Q

medwatch

A

FDA’s safety and adverse event reporting program

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23
Q

joint commision

A

NPO enhances patient safety and quality of care in hospitals

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24
Q

the scope of practice defines

A

whether practitioner can diagnose a condition

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25
Q

respondeat superior doctrine states that if patient recieves the incorrect medication, these 3 parties are responsible

A

PT, pharmacist, pharmacy

26
Q

what is the ratio of pharmacist to PT

A

1:3

27
Q

controlled substances act (CSA) - what is it and who regulates and enforces it?

A

-regulation controlled substances
-FDA regulates it
-enforced by the drug enforcement agency (DEA)

28
Q

What are the 5 levels of scheduled drugs and examples of each?

A

1 - illegal drugs with no medical use, highest chance of abuse (include marijuana)
2 - legal but high chance of abuse (opioids & amphetamines)
3 - moderate physical abuse but high psychological abuse (anabolic steroids)
4 - low physical abuse but moderate psychological abuse (tranquilizers and sleeping aids)
5 - low potential for abuse

29
Q

schedule 2 drugs (14)

A

cocaine, oxycodone, hydrocodone, amphetamines, methadone, methamphetamine, methyphenidate, amobarbital, pentobarbital, morphine, codeine, opium, fentanyl, glutethimide

30
Q

schedule 3 drugs (5)

A

benzphetamine, phendimetrazine, depo-testosterone, buprenorphine, anabolic steroids

31
Q

schedule 4 drugs (3)

A

-pams, tramadol, carisoprodol

32
Q

schedule 5 drugs (3)

A

marinol, ezogabine, lonox

33
Q

access to controlled substances requires DEA registration through the form ___.
who requires DEA registration? (6)

A

DEA form 224
doctors, distributors, importers, exporters, manufacturers, pharmacies

34
Q

a DEA # consists of (3)
the second letter

A

2 letters, 6 #s, 1 check digit
second letter = initial of practitioner last name

35
Q

the first letter of DEA stands for
A
B
C
M

A

A - deprecated
B - hospital/clinic
C - practitioner
M - mid-level practitioner

36
Q

to check the DEA # - 3 steps

Ex AL2455562

A

1 = add 1st, 3rd, 5th number
2 = add 2nd, 4th, 6th number and multiply by 2
3 = add the two numbers together, the last digit should match last number

ex.
1 = 2+5+5 = 12
2 = 4+5+6x2 = 30
3 = 12+30=42
2 is the last DEA number

37
Q

c2 prescriptions expire ___ days after written date
C2 can be for ___ day supply
there can/not be refills
C3-c4 can have up to __ refills

A

7 days
30 days
no refills
6 months, 1 original + 5 refills

38
Q

controlled substances labels must include (11)

A

pharmacy name, address, phone #, date of fill, prescribers name, NDC, patient name/address, order #, directions for use, auxiliary labels

39
Q

C2s must be verified every ___ days and kept a perpetual inventory. c3-c4 can be ___

A

10
estimated

40
Q

what is documented on a perpetual inventory log for C2s (3)

A

drug order info
blance/quanitity after each transaction
receipt by drug manufacturer

41
Q

when keeping hard copies of controlled substances on record, a ___ must be stamped in the lower ___ hand corner

A

red C stamp in lower right hand corner

42
Q

emergency dispensing (oral prescriptions) can be dispensed when ___. the dispensed quantity should not last more than ___ days (emergency period). pharmacists fill out the prescription in good faith, meaning the prescription will be filled within __ days

A

physician out of area and cannot write a written prescription
3 days
7 days

43
Q

C3-C5s can be partial filled

C2 partial fill must be completed in ___ days

A

true
3 days

44
Q

true or false

physicians and pharmacies can use e-prescribing for controlled substances if their software has been certified by a third-party auditor

A

true

45
Q

true or false

c3-c4 drugs are secured by locks of the pharmacy (allows only authorized personnel with a key through)

A

true

46
Q

DEA form 222

A

form for ordering/returning/transferring controlled substances

47
Q

this form is used to transfer C2s among different DEA-registered pharmacies

A

DEA form 222

48
Q

expired C2s are returned to ____ using form ___. if the pharamacy decides to destroy it itself, they use the form ___

A

reverse distributors using form 222
DEA form 41

49
Q

this form is filled out for smaller theft/losses of controlled substances. the pharmacist must contact the ___

A

DEA form 106, contact DEA

50
Q

what is the purpose of the prescription drug monitoring program (PDMP) (3)

A

-identify and prevent drug abuse/diversion
-support access to legitimate medical use of controlled substances
-inform public health of use/abuse trends

51
Q

combat methamphetamine epidemic act of 2005 (CMEA), what grams?

A

regulates ephedrine and pseudophedrine sales
30 day supply is limited to 9 grams in retail enviornments or 3.6g per day

52
Q

what are high alert medications? what are the high alert medications? (6)

A

those that have to be handled carefully because errors can have serious effects.

heparin
opioids
potassium chloride injections
insulin
neuromuscular blocking agents
chemotherapeutic agents

53
Q

what are in the do not use abbreviation list (11)

A

unit
international unit (IU)
trailing 0 (1.0)
lack of leading 0 (.0)
MS MSO4 MgSO4
> or <
drug abbreviations
apothecary units
@
cc
ug (microgram)

54
Q

causes of medication errors (4)

A

patients physiological makeup
calculation errors
social causes (compliance)
abbreviation errors

55
Q

requirements to handle SALAD drugs (5)

A

look alike sound alike drugs

tallman lettering
keep SALAD meds away from other
develop precaution policies and procedures
annual review

56
Q

if stock bottle states the expiration date is 5/20 it expires

A

on the last day of may 2020

57
Q

stock bottles must be removed from the shelf ___ (time) before expiration date

A

one month

58
Q

FMEA - what is it and what are the 5 steps?

A

failure mode and effect analysis - inspect products to proactively determine possible failure to avoid errors

  1. determine how to use product
  2. determine possible failures
  3. determine likelihood and consequences of errors, why the error is occuring
  4. factor in pre-existing conditions of patient & any processes that may cause error. account for human factors to determine effectiveness of drug
  5. is any significant errors occur, take actions to minimize/prevent consequences
59
Q

what are the methodologies used for continuous quality improvement (CQI) to reduce errors? (3)

A

FMEA - failure mode and effects analysis
RCA - root cause analysis
FOCUS - PDCA

60
Q

enforce the Resource Conservation and Recovery Act of 1976

A

EPA

Pharmacy Technician University (7 decks)

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