Law and Ethics Flashcards
pure food and drug act of 1906
label drugs with truthful information
harrison narcotics tax act of 1914
stop recreational use of opium
food drug and cosmetic act of 1938 (2)
banned misbranding/false claims
established the pharmacopeia (USP) and national formulary for strength, purity, quality of drug
durham-humphrey amendment of 1951
required prescriptions for drugs (vs OTC meds)
label caution, prohibits dispensing without prescription
kefauver-harris amendment of 1962 (2)
gave FDA authority to approve/reject manufacturer’s marketing applications
forced manufacturers to provide evidence & efficacy thru scientific studies
poison prevention packaging act of 1970
all containers have childproof packaging
drug listing act
implemented the national code number (NDC)
medical device amendment of 1976
establishes 3 classes of medical device, 3 being the most risk and 1 being low risk
orphan drug act f 1983
help development of rare diseases
drug price competition and patent term restoration act of 1984
encourages manufacturing of generic drugs
prescription drug marketing act of 1987
prevent counterfeit (misbranded, subpar, expired prescriptions) drugs
FDA safe medical devices act
medical device reporting (MDR) of medical device incidents
anabolic steroids control act of 1990
control steroid use as c3 drug
dietary supplement health and education act of 1994
regulates supplements
health insurance portability and accountability act (HIPPA) of 1996
-established protected health info (PHI) - includes payment for healthcare that identifies individual
-National Provider Identifier (NPI) is assigned to practitioners
what are the HIPPA violation tiers
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
medicare prescription drug improvement and modernization act of 2003
prescription discount card for low income patients
dietary supplement and nonprescription drug act of 2006
requires reporting of adverse events caused by supplements and nonprescription drugs
patient protection and affordable care act of 2010
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
drug quality and security act of 2013
electronic tracking system to identify and trace prescription drugs
state board of pharmacy (BOP) vs national association of boards of pharmacy (NABP)
BOP = enforce pharmacy law & public health
NABP = assists BOP by building standards; licensing of pharmacists and PTs
medwatch
FDA’s safety and adverse event reporting program
joint commision
NPO enhances patient safety and quality of care in hospitals
the scope of practice defines
whether practitioner can diagnose a condition
respondeat superior doctrine states that if patient recieves the incorrect medication, these 3 parties are responsible
PT, pharmacist, pharmacy
what is the ratio of pharmacist to PT
1:3
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)
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
schedule 2 drugs (14)
cocaine, oxycodone, hydrocodone, amphetamines, methadone, methamphetamine, methyphenidate, amobarbital, pentobarbital, morphine, codeine, opium, fentanyl, glutethimide
schedule 3 drugs (5)
benzphetamine, phendimetrazine, depo-testosterone, buprenorphine, anabolic steroids
schedule 4 drugs (3)
-pams, tramadol, carisoprodol
schedule 5 drugs (3)
marinol, ezogabine, lonox
access to controlled substances requires DEA registration through the form ___.
who requires DEA registration? (6)
DEA form 224
doctors, distributors, importers, exporters, manufacturers, pharmacies
a DEA # consists of (3)
the second letter
2 letters, 6 #s, 1 check digit
second letter = initial of practitioner last name
the first letter of DEA stands for
A
B
C
M
A - deprecated
B - hospital/clinic
C - practitioner
M - mid-level practitioner
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
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
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
C2s must be verified every ___ days and kept a perpetual inventory. c3-c4 can be ___
10
estimated
what is documented on a perpetual inventory log for C2s (3)
drug order info
blance/quanitity after each transaction
receipt by drug manufacturer
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
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
C3-C5s can be partial filled
C2 partial fill must be completed in ___ days
true
3 days
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
true or false
c3-c4 drugs are secured by locks of the pharmacy (allows only authorized personnel with a key through)
true
DEA form 222
form for ordering/returning/transferring controlled substances
this form is used to transfer C2s among different DEA-registered pharmacies
DEA form 222
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
this form is filled out for smaller theft/losses of controlled substances. the pharmacist must contact the ___
DEA form 106, contact DEA
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
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
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
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)
causes of medication errors (4)
patients physiological makeup
calculation errors
social causes (compliance)
abbreviation errors
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
if stock bottle states the expiration date is 5/20 it expires
on the last day of may 2020
stock bottles must be removed from the shelf ___ (time) before expiration date
one month
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
- determine how to use product
- determine possible failures
- determine likelihood and consequences of errors, why the error is occuring
- factor in pre-existing conditions of patient & any processes that may cause error. account for human factors to determine effectiveness of drug
- is any significant errors occur, take actions to minimize/prevent consequences
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
enforce the Resource Conservation and Recovery Act of 1976
EPA
