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Pharmacy Technician University > Law and Ethics > Flashcards

Law and Ethics Flashcards

(60 cards)

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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
respondeat superior doctrine states that if patient recieves the incorrect medication, these 3 parties are responsible
PT, pharmacist, pharmacy
26
what is the ratio of pharmacist to PT
1:3
27
controlled substances act (CSA) - what is it and who regulates and enforces it?
-regulation controlled substances -FDA regulates it -enforced by the drug enforcement agency (DEA)
28
What are the 5 levels of scheduled drugs and examples of each?
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
schedule 2 drugs (14)
cocaine, oxycodone, hydrocodone, amphetamines, methadone, methamphetamine, methyphenidate, amobarbital, pentobarbital, morphine, codeine, opium, fentanyl, glutethimide
30
schedule 3 drugs (5)
benzphetamine, phendimetrazine, depo-testosterone, buprenorphine, anabolic steroids
31
schedule 4 drugs (3)
-pams, tramadol, carisoprodol
32
schedule 5 drugs (3)
marinol, ezogabine, lonox
33
access to controlled substances requires DEA registration through the form ___. who requires DEA registration? (6)
DEA form 224 doctors, distributors, importers, exporters, manufacturers, pharmacies
34
a DEA # consists of (3) the second letter
2 letters, 6 #s, 1 check digit second letter = initial of practitioner last name
35
the first letter of DEA stands for A B C M
A - deprecated B - hospital/clinic C - practitioner M - mid-level practitioner
36
to check the DEA # - 3 steps Ex AL2455562
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
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
7 days 30 days no refills 6 months, 1 original + 5 refills
38
controlled substances labels must include (11)
pharmacy name, address, phone #, date of fill, prescribers name, NDC, patient name/address, order #, directions for use, auxiliary labels
39
C2s must be verified every ___ days and kept a perpetual inventory. c3-c4 can be ___
10 estimated
40
what is documented on a perpetual inventory log for C2s (3)
drug order info blance/quanitity after each transaction receipt by drug manufacturer
41
when keeping hard copies of controlled substances on record, a ___ must be stamped in the lower ___ hand corner
red C stamp in lower right hand corner
42
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
physician out of area and cannot write a written prescription 3 days 7 days
43
C3-C5s can be partial filled C2 partial fill must be completed in ___ days
true 3 days
44
true or false physicians and pharmacies can use e-prescribing for controlled substances if their software has been certified by a third-party auditor
true
45
true or false c3-c4 drugs are secured by locks of the pharmacy (allows only authorized personnel with a key through)
true
46
DEA form 222
form for ordering/returning/transferring controlled substances
47
this form is used to transfer C2s among different DEA-registered pharmacies
DEA form 222
48
expired C2s are returned to ____ using form ___. if the pharamacy decides to destroy it itself, they use the form ___
reverse distributors using form 222 DEA form 41
49
this form is filled out for smaller theft/losses of controlled substances. the pharmacist must contact the ___
DEA form 106, contact DEA
50
what is the purpose of the prescription drug monitoring program (PDMP) (3)
-identify and prevent drug abuse/diversion -support access to legitimate medical use of controlled substances -inform public health of use/abuse trends
51
combat methamphetamine epidemic act of 2005 (CMEA), what grams?
regulates ephedrine and pseudophedrine sales 30 day supply is limited to 9 grams in retail enviornments or 3.6g per day
52
what are high alert medications? what are the high alert medications? (6)
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
what are in the do not use abbreviation list (11)
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
causes of medication errors (4)
patients physiological makeup calculation errors social causes (compliance) abbreviation errors
55
requirements to handle SALAD drugs (5)
look alike sound alike drugs tallman lettering keep SALAD meds away from other develop precaution policies and procedures annual review
56
if stock bottle states the expiration date is 5/20 it expires
on the last day of may 2020
57
stock bottles must be removed from the shelf ___ (time) before expiration date
one month
58
FMEA - what is it and what are the 5 steps?
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
what are the methodologies used for continuous quality improvement (CQI) to reduce errors? (3)
FMEA - failure mode and effects analysis RCA - root cause analysis FOCUS - PDCA
60
enforce the Resource Conservation and Recovery Act of 1976
EPA

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