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SC MPJE Study Guide: Pharmacy Law & Regulations

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South Carolina MPJE
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1.
Are registration/permits
transferable?
NO! If ownership or location
changes, you have to get a new
permit
2.
Can a CS drug have
preprinted Rx?
No!
3.
Can a person be PIC at
more than one location?
No, you can only be the PIC at
one location. However, the BOP
may make an exception if you
live in a rural area.
4.
Can non-controlled
drugs have preprinted
Rx?
Yes, but only 1 drug/set of
instructions.
5.
Can these references be
electronic?
Yes, these can be stored
electronically; but you need to be
able to access them quickly.
6.
Can you fill a Rx in a SC
pharmacy for a CII
written by a NP from
NC?
No, because NPs in SC can't
write CIIs.
7.
Can you receive a
telephone (oral) Rx
order from a nurse
practitioner?
Yes you can.
8.
Describe Electronic
Prescribing?
1) Routing compnay registers with
BOP 2) Rx format meets all
requirements of 40-43-86(E);
generic substitution instructions
must be clear 3) Must maintain
integrity/confidentiality of Rx/pt
info 4) Pharmacy can NOT
incentivize e-prescribers
9.
Describe the
area/equipment needed
for
compounding/dispensing
Rxs?
1) Ventilation/lighting 2) Orderly
inventory 3) Separte
outdated/damaged stock 4)
Refrigerated stock 5) Labeled
compounded materials 6)
Compounding-only area 7) Clean
instruments; designated sink for
compounding 8) Good hygiene!
10.
Describe the paitent
record system needed
for a pharmacy?
1) Maintained by all pharmacies
for each patient 2) Be able to
immediately retrieve Rx history
11.
Describe the
requirements for
Records for Dispensing
1) Ready/Retrievable within 24
hours (non-CS) 2) Includes
dates/quantities, serial number,
dispensing RPh, drug
name/manufacturer 3) Maintained
for 2 years from original date or
date of last activity
12.
Describe what
counts as an
accptable prescriber
signature.
Original signature only! No stamps or
printed.
13.
Describe what drug
schedules a PA can
prescribe?
CIII-CV controlled substances, if
registered by DHEC. Can prescribe
CIIs. Oral CII dose limited to 72
hours. Parenteral CII dose limited to
24 hours.
14.
Describe what
schedules an
optometrist can
prescribe.
They can prescribe CIII-V analgesics
(not Class II); the Rx can only be for
a 7 day supply or less
15.
Describe what types
of records a
wholesale distributor
must maintain? How
long do they have to
be kept?
1) Records for
receipt/distribution/disposition that
includes: source,
identity/quantity/dates 2) Must be
maintained for 2 years
16.
Does a pharmacist
working in a mail
order pharmacy
permitted in SC,
need a SC license?
No, unless the pharmacist is engaged
in the practice of pharmacy in SC
(physically in SC)
17.
Explain a grouppurchasing
organization?
An example would be independent
pharmacies joining together to get a
better price.
18.
Explain an
emergency medical
reason?
The transfer of legend drugs by a
pharmacy to another pharmacy to
alleviate a temporary shortage; may
only be less than 5% of the total
legend drug sales for both parties in
a 12 month period
19.
Explain an
intracompany sale?
Is a transaction or transfer between 2
divisions under the same ownership
and control of a coporate entity; Ex:
transfer between 2 CVS locations
20.
Explain the 10 Day
Rule of when you
have to notify the
BOP.
1) Leaving or Starting a Job 2) PIC
Change 3) Consultant Pharmacist
change 4) Address change (facility or
person) 5) Permanent closing of
facility 6) Name changes (marriage,
divorce, etc)
21.
Explain the
classification of a
Medical
Gases/Legent
Devices (facility)
Permit.
1) For Durable Medical companties,
oxygen 2) Dispense by prescription
order 3) Has an Consultant RPh or
appointed
22.
23.
24.
25.
26.
27.
28.
29.
Explain the
classification
of a Nondispensing
Drug Outlet
(facillity)
permit.
1) Is a permit to store drugs; no direct
dispensing to pt 2) Administer & store drugs
3) SubCategories: FQHC (federally qualified
health center), Detention Centers, EMS 4) Has
a Consultant Pharmacist (once a month min)
Explain the
classification
of a NonResident
Pharmacy
(facility)
permit.
1) Is needed in order to sell, distribute,
dispense in SC 2) Mail order pharmacies,
manufacturers/compounding
Explain the
classification
of a
Pharmacy
(facillity)
permit.
1) This permit is required for direct pt
care/dispensing 2) Facility dispenses legend
drugs/devices to patients 3) Has to have a
Pharmacist-in-charge (PIC)
Explain the
requirements
to maintain a
technician
license.
1) Registration expires ANNUALLY on June
30th. 2) 10 hours of CE annually; 4 live hours,
ACPE and CME I
Explain the
requirements
to maintain
your
Pharmacist
license.
1) Annually renew liscense by April 30th;
application/fee must be sent by April 1st 2)
CE requirment of 15 hours annually; 6hrs must
be live, 50% of credit must be drug
therapy/pt management; hours must be
accredited by ACPE or CME I)
For a CS with
PRN refills,
how long is
the Rx good
for?
PRN=5 refills or 6 months; no refills unless
indicated.
For a non-CS
with PRN
refills, how
long is the
Rx good for?
2 years date of issue. Technically, the
prescription never expires, but you should be
using your clinical judgement.
How do you
obtain a BOP
permit?
1) Each physical location must be permitted.
2) Permits expire ANNUALLY: June 30th (also
the day when techs have to reapply for
license) 3) Written application for a new
permit must be submitted to BOP at least 45
days BEFORE the opening of the facility
30.
How long can an
optometrist prescribe a
topical steroid for?
21 day supply or less
31.
How long is a term in the
BOP?
6 years, with up to 2
consecutive terms. May be
longer if filling a position midterm, or if governor hasnt
appointed new member.
32.
How many signatures
lines must be present on
a Rx?
There must be 2 lines; dispense
as written (on left) and
substitution permitted (on right)
33.
How often does the BOP
inspect facilities?
Biennial (every 2 years)
34.
How quickly do
centralized Rx records
need to be able to send
requested printouts?
Within 72 hours
35.
How quickly do you have
to report a loss of data or
breach for automated
systems?
Within 72 hours
36.
How quickly must a
wholesale distributor
notify the BOP of permit
changes?
30 days
37.
If you are a floating RPh,
what should you carry
with you?
You should have your wallet
card with you at all times, while
working.
38.
If you recognize an issue
while reviewing a patient
record, what should you
do?
The pharmacist shall attempt to
avoid/resolve the problem, and
contact practitioner if necessary.
39.
In an institutional
pharmacy, what is the
employment ratio of
pharmacist: techs?
Have to hire at ratio of 1:3, but
the daily operational ratio is
determined by PIC, so can
exceed this ratio
40.
Is their a requirement for
refill amount?
No there is not. However,
remember that NPs have to
specify refills.
41.
Is the patient record a
legal document?
Yes! So don't put anything in it
that you don't want the patient
to read
42.
Laws establish the ___
requirements of
pharmacy practice.
Minimum; you probably will
exceed these guidelines to have
good quality of care.
43.
Nurse practitioners shall
perform delegated
medical acts. What does
delegated medical acts
include?
1) Diagnosing 2) Treating 3)
Prescribing 4) Identify need for
referral
44.
True or False?
Every permit
holder issued
by BOP
requires a
consultant
pharmacist.
Generally true, but there are a few
exceptions. Pharmacies (they have PIC
instead), Wholesalers, and Oxygen-only
facilities don't need a consultant pharmacy
(bc there is no administration of meds to pt)
45.
True or False?
For out-ofstate Rx, you
should follow
SC laws?
True! The SC laws are always what you
follow, no matter where the Rx is from.
True or False?
You can eprescribe
controlled
substances in
SC @ this
time?
True
What 4
additional
duties do
State Certified
Techs have?
1) Receive/initiate verbal orders 2) Conduct
non-CS Rx transfers (CS Rx transfers have
to be between 2 RPh) 3) Check technician's
medication refill 4) Check repackaging 3-4
is only in institutional settings
What are 5
examples of
Unprofessional
Conduct?
1) Circumvent counseling requirments 2)
Violate patient confidentiality 3) Sell
drugs/devices for illegal use 4) Sell without
a Rx 5) Incomplete records
What are 7
References to
keep on hand
in the
pharmacy?
1) Pharmacy Practice Act 2) Controlled
Substances Act 3) Drug Act 4) BOP
Newsletter 5) Equivalent Drug Product
Evaluations 6) Facts & Comparisons 7)
Patient-oriented information (monographs)
What are some
duties of a
registered
Technician?
1) Provide effective, appropriate, and safe
pharmacy services 2) Prepare Rxs 3)
Handle legend drugs 4) Compound and
mix medications
51.
What are some
examples of a
Wholesale
Distributor?
1) Manufacturers 2) Repackagers 3) Retail
pharamcies, if appropriate 4) Warehouses
of manufactures, wholesalers, chain drugs
52.
What are some
policies and
procedures
needed for
Automated
Systems?
1) Ouput documentation 2) System
interruptions (scheduled or unsched) 3)
Backup file procedures/maintenanceoutline process 4) Audit procedures: assign
personal codes, access responsibilities 5)
Quality assurance mechanism: data entry
validation
46.
47.
48.
49.
50.
53.
What are
some policies
and
procedures
needed for
Automated
Systems?
(continued)
1) Refill-by-Refill audit trail that includes:
print out for any drug, ID
prescriber/patient/RPh, Dates/quantities,
serial number
54.
What are
some policies
and
procedures of
a wholesaler
facility?
1) Oldest stock distributed FIRST 2)
Procedure for recalls & withdrawals must be
able to deal w/: Fed/state action,
manufacturer voluntary actions,
replacement with new product for public
health/safety 3) Outdated drugs are
segregated from other drugs
55.
What are
some
requirements
for Mail Order
Pharmacies?
1) Be permitted in SC 2) Report location,
names of officers/pharamcists 3) Comply
with laws 4) Annually provide copy of
inspection report 5) Records must be
maintained
56.
What are the 3
types of
Pharmacist
liscense, and
explain them.
1) Active 2) Inactive: not actively engaged in
pharmacy; to become reinactivated,
complete 15 hours of CE 3) Lapsed: not
renewed by May 1st; will require fees, law
exam, and a lot of CE hours, depending on
length of lapse
57.
What are the
4 primary
functions of
the BOP?
1) Permit facilities 2) License Pharmacists 3)
Register Techs 4) Register Interns
58.
What are the
4 types of
licenses that
may be seen
in a
pharmacy?
1) Pharmacist 2) Technician 3) Interns 4)
Facility permit
59.
What are the 5
duties of the
pharmacist
when
practicing
pharmacy?
1) Rx drug orders (Interpret, evaluate,
dispense) 2) Participate in selection, admin,
reviews, research 3) Pharmacy care; drug
therapy management 4) Compound and
labeling, safe storage of drugs/devices 5)
Control pharmacy and personnel
60.
What are the 5
requirements
to be a State
Certified
Technician.
1) 1000 hours of experience 2) Complete
BOP-approved course 3) High school
diploma/equivalent 4) Pass PTCB exam 5)
Annual CE requirement of 10 hours
61.
What are the 7
duties of a
pharmacist
(include, but
not limited
to..)?
1) Interpret and evaluate medical orders 2)
select drug/device 3) Counsel patient 4)
Review drug regimens 5) Provide pharmacy
care 6) Receive orders 7) Supervise techs
69.
What are the
standards for
prescriptive
authority for
nurse
practitioners?
1) Shall comply with all state and fed laws 2)
Within the speciality of the NP (written
protocol) 3) May prescribe CIII-CV, if
registered by DHEC
62.
What are the
10
responsibilities
of the BOP?
1) Practice of Pharmacy 2) Sale/dispensing
drugs/poisons/devices 3) Supervision of
interns/externs 4) Investigate violations 5)
Min requirement of permits 6) Confine
drugs to Rx status 7) Seize dangerous
drugs/devices 8) Promulgate regulations
70.
What
disciplinary
powers does
the BOP
possess?
They can cancel, fine, suspend, revoke, or
restrict authorization to practice. Fine can not
exceed $500, unless otherwise stated. They
also have other "resonable" actions deemed
necessary and appropriate by BOP.
71.
What does a
"Wholesale
Distributor"
NOT include
(3 things)?
1) Intracompany sales 2) Group-purchasing
organization 3) Emergency medical reasons
72.
What does
the Nurse
Dispensing
Act say?
Under the guidance of an RPh and direction
of an MD, registered nurses may dispense
drugs for the treatment of TB, VD< maternal
and infant care, crippled children, family
planning, immunization and other public
health programs (DHEC establishes policies)
73.
What do you
have to do to
be the
Consultant
pharmacist?
Agree in writing to assume responsibilities (&
notify the BOP w/in 10 days); signs/renew
permit application.
74.
What drugs
are
optometrist
limited to
prescribing?
1) Anesthetics 2) Antihistamines 3)
Antimicrobials 4) Antiglaucoma 5) OTC
drugs
75.
What gives
nurses
prescriptive
authority?
The Nurse Dispensing Act (40-33-30)
76.
What
happens if
you are
audited for
CE hours by
BOP?
10% of license holders will be audited; will
have to show proof of 15 hours completion
by time you submitted your application. So if
you submit on March 28, but you finish your
hours on March 29, you will be in trouble.
77.
What
happens
(punishment )
if you violate
the Pharmacy
Practice
Statues?
1) misdemeanor for violations of any
provision 2) In most cases, a $500 fine for
each offense, or up to 2 years imprisonment,
or both. There are provisions for civiil
penalties up to $10,000 3) Unprofessional
conduct
63.
What are the
10
responsibilities
of the BOP?
(continued)
9) License, register, permit 10) Adopt rules
of conduct
64.
What are the
duties of an
intern/extern?
1) Interpret orders 2) Select drug/device 3)
Counsel 4) Drug regimen reviews 5)
Pharmacy care 6) Receive orders Basically
do the same thing as a pharmacist, but
under their supervision
65.
What are the
facility
requirements
to be a
wholesale
distributor?
1) Suitable size with adequate storage areas
2) Quarantined area for damaged/out of
date 3) Clean and orderly conditions 4)
Free from infestation 5) Secure from
unauthorized entry 6) Controlled access
from outside 7) Outside perimeter well
lighted 8) Limited access 9) Alarm system;
Security system
What are the
inspections
for, and who
are the
inspectors?
Inspectors are pharmacists. They are
looking for compliance to BOP regulations.
What are the
practical
experience
requirements
to receive
your
Pharmacist
liscense?
1) 1500 hours of practical experience (500
from work, 1000 from school rotations) 2)
Experience must be supervised by licensed
RPh 3) Experience can't be more than
40hrs/wk 4) Intern is responsible for
paperwork to BOP 5) Must have an intern
liscense
What are the
requirements
for a
Pharmacy
facility?
1) Sufficient Size 2) Maintain area for patient
counseling; has reasonable privacy 3)
Maintain current drug references materials
4) Update drug monographs QUARTERLY 5)
Update product information QUARTERLY 6)
Update new development information
QUARTER
66.
67.
68.
78.
What is a chart
order?
Lawful order from a practioner for a drug
or device for patients of hospital or
extended care facility
89.
What is the
Code of Ethics?
The American Pharmaceutical Assoc.
Code of Ethics are adopted as the SC
Code of Ethics. There are 8 statements.
79.
What is a
definition of
an extern?
When a pharmacy student is working
somewhere for school credit; non-paid
position; doesn't apply to pharmacist:tech
ratio
90.
1) Toll free service number for patients 2)
Number prsent on label
80.
What is a
defintion of an
intern?
When a pharmacy student is working
somewhere for experience (non-school); is
a paid position; applies to employment
ratio
What is the
contact
information
requirement for
mail order
pharmacies?
91.
81.
What is an
consultant
pharmacist?
A pharmacist licensed in SC who acts as a
consultant for a permit holder OTHER than
a pharmacy or an institution.
What is the
definition of
administer?
The direct application of a drug or device
by practioner's lawful order to the body
of a patient by injection, inhalation,
ingestion, topical application, or any other
means.
82.
What is a
Wholesale
Distributor?
A Person engaged in wholesale distribution
of prescription drugs/devices
92.
83.
What is
considered
clerical
duties? This is
not covered in
Practice Act
1) Enter basic info 2) Order inventory 3)
Billing 4) Nonprofessional inquiries (not
refills) 5) Process sales transactions
What is the
definition of a
Pharmacist-inCharge?
A pharmacist licensed in SC who
ACCEPTS responsibility for the
operations of a pharmacy in
conformance with all laws pertinent to the
practice of pharmacy and the distribution
of drugs and who is in full & actual
charge of the pharmacy & personnel
93.
Anyone authorized by law to diagnose
and prescribe drugs and devices
84.
What is Drug
Regimen
Review
include (but is
not limited
to)?
Evaluation of Rx drug orders and pharmacy
records for: allergies, therapy CIs,
reasonable prescriptions, duplication of
therapy, interactions (drugs, food, disease,
ADR), and proper utilization.
What is the
definition of a
practitioner?
94.
What is the
definition of a
prescription?
85.
What is
required for a
Rx Drug
order?
1) Pt info (name, address) 2) Prescriber info
(name, contact info, degree, liscense , DEA
if applicable) 3) Date of issue (CS:
Date/signed on date of issue) 4) Drug info
(name, strength, dosage form, quantity,
directions for use)
1) Oral or written order 2) Legitimate
medical purpose 3) W/in the practiioner's
scope of practice 4) Given individually for
specific pt 5) Directly from the prescriber
or prescriber agent to pharmacist or
pharmacist's agent
95.
What is the
definition of a
(State) Certified
Pharmacy
Technician?
An individual who is a registered
pharmacy technician and who has
completed the requirements set forth in
40-43-82(B).
86.
What is
required on a
eprescription?
1)Rx IDs transmitter & recipient 2) Pharmacy
of patient's choice 3) Secure prescriber
signature and digital code 4) There should
be a pt-practitioner relationship
96.
What is the
defintion of
Drug therapy
management?
87.
What is SC
Code of Law
Title 40,
Chapter 43
called?
SC Pharmacy Practice Act
The practice of pharmacy that involves the
expertise of the pharmacist in a
Collaborative effort with practioner to
ensure the highest quality health care
services for patients.
97.
Don't need a Consultant Pharmacist if
facility only manufactures, wholesales,
and distributes drugs/devices.
88.
What is the
civil penalty
for not
displaying the
original copy
of the permit?
$50
What is the
exception to
having a
Consultant
Pharmacist for a
Non-dispensing
Drug Outlet
permit?
98.
What is the max
employment
ratio of
pharmacist,
techs, and
certified techs?
1 pharmacist: 3 technicians; as long as 2
of these technicians are state certified.
99.
What is the max
ratio of
pharmacists to
techs in a mail
order
pharmacy?
1 Pharmacist to 2 Techs
What is the
minimum Hours
of Operation
for a Mail order
pharmacy?
6 days or 40 hours/week
What is the
minimum
requirement for
a patient's
record?
1) Full name 2) Address/telephone
number 3) Age/DOB 4) Gender 5) Rx
within past 2 years (Drug, refills,
dispensing RPh, Prescriber) 6) Comments
on patient/drug therapies
What is the
most common
punishments?
100.
101.
102.
103.
What is the
purpose of
reviewing a
patient record?
108.
What other duties
does the consultant
pharmacist have?
1) Drug Information Resource
(provide info, be available by
phone) 2) Monthly inspections for
compliance (look at all pt charts
monthly) 3) Monthly patient record
review (document review and advise
physician)
109.
What
policies/procedures
does the consultant
pharmacist need to
establish/implement?
1) Drug recordkeeping system (what
& how its used) 2) Recalls (at patient
level) 3) Remove
outdated/adulterated drugs 4)
Employee duties (who's allowed to
do what with the meds)
110.
What
policies/procedures
is the PIC
responsible for at an
Institution?
1) Provision of drugs in absence 2)
Authorized access 3) Night cabinet
inventory list 4) Stop-order policy
111.
What sort of
storage/shelving/etc
is required?
1) Reprimand or letter of caution (public
or private) 2) Fine (usually up to $500) 3)
Probation (with conditions) Revocation of
license is rare, but for extreme violations.
1) Storage- at proper temperatures 2)
Sink with Hot & Cold water 3)
Pharmacist on duty when open 4)
Secure pharmacy with barriers 5)
Sign stating "Pharmacy Dept closed,
pharmacist not on duty" 6)
Necessary equipment/supplies
112.
1) Promoting therapeutic appropriateness
by identifying: 2) Over/under utilization 2)
Duplicate Tx 3) Disease CI 4) Drug
interactions 5) Incorrect dose or duration
6) Allergies 7) Abuse/misuse
What specifically can
a tech do to
compound and mix
medications?
1) Mix with water to activate 2)
Prepare IV solutions 3) Repackage
bulk medications *If compounding,
they should have CE that covers
compounding*
113.
What specifically can
a Tech do to prepare
a Rx?
1) Receive orders (only State techs
can accept new Rx orders) 2) Refill
requests 3) Initial order
interpretation 4) Rx entry 5) Maintain
unit dose carts/cassettes (but be
checked by RPh) *Techs can NOT
call or clarify orders with MD**
114.
What specifically can
a tech do when
handling legend
drugs?
1) Check for outdates 2)
Accept/stock shipments 3) Process
for returned credit 4) Stock
automatic dispensers
115.
What types of
medical information
is necessary patient
information?
1) Allergies 2) Drug reactions 3)
Idiosyncrasies related to health care
4) Diagnoses 5) Other medications
116.
What types of nurses
have prescriptive
authority?
1) Nurse practitioner (NP) 2)
Certified nurse practitioner (CNP 3)
Certified registered nurse anesthetist
(CRNA)
104.
What is the
purpose of the
Pharmacy
Practice Act?
To promote, preserve, and protect the
public health, safety and welfare... (PPA
40-43-10)
105.
What is the ratio
of pharmacists
to
interns/externs?
1 pharmacist for 1 intern/extern
What is the
required form
for Rx for NPs?
1) Include the NPs AND Physician's name,
address, phone 2) Complies with all Rx
laws 3) Must designate specific number
of refills 4) Any drugs or devices
prescribed (document in patient record)
What is the
structure of the
BOP?
7 are RPhs from congressional districts, 2
members are appointed by Governor (1
layperson, 1 pharmacist at large)
106.
107.
117.
What types of
positions do NOT
count into the
employment
ratio?
1) Clerical support 2) Interns/externs 3)
Technician students on rotation
118.
When do you
have to apply for
a new permit (3
situations)?
1) Change of ownership 2) Change in
pharmacy name 3) Change in location
119.
When is a
physician's
assistant able to
prescribe?
May prescribe if certified by Board of
Medical Examiners
120.
When you update
new
development
information, what
specifically
needs to be
updated?
1) Drug therapy 2) Investigational agents
3) New products or changes
121.
When you update
product
information, what
specifically
needs to be
updated?
1) Legend status 2) Controlled
Substance schedule 3) Available
strengths, dosage forms, package sizes
122.
Which two
agencies regulate
pharmacy in SC?
LLR/BOP and DHEC Bureau of Drug
Control
123.
Who can be
employed in a
pharmacy?
1) PIC 2) Consultant RPh 3) RPh 4)
Registered Techs 5) State Certified Techs
(CPhT) 6) Interns/Externs 7) Clerical
staff 1-6 have to be permitted by BOP!!
124.
Who is
responsible for
making
regulations? For
making Laws?
State agency makes regulations, but has
to be approved to be a law by state
Legislature.
125.
Who may write a
prescrition in SC?
8 people
1) Physician (MD) 2) Dentist (DMD, DDS)
3) Osteopath (DO) 4) Podiatrist (DPM)
5) Veterinarian (DVM) 6) Nurse
practitioner (NP, CNP) 7) Optometrist
(OD) (Opthalamist is a MD) 8) Physician
Assistant (PA)
126.
Who
needs a
PIC? What
do they
do at a
pharmacy?
1) Every permit holder needs a PIC; may be
part-time 2) PIC is in charge of
policies/procedures, record keeping systems,
notify BOP of changes, file required reports,
respond to BOP violations, sign/renew
pharmacy permit, ensures proper
license/registrat
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