Regarding CI drugs,
(A) The drug or other substance has a ___
(B) The drug or other substance has ___in the United States.
(C) There is a ___
high potential for abuse. no currently accepted
medical use in treatment lack of accepted safety for use of
the drug or other substance under medical supervision
Regarding CII drugs,
(A) The drug or other substance has a ___
(B) The drug or other substance has ___in the United States.
(C) Abuse of the drug or other substances may lead to___
a high potential for abuse. has a currently accepted
medical use in treatment in the United States or a currently
accepted medical use with severe restrictions = this is TRUE for
CII- CV severe psychological or physical dependence
Regarding CIII drugs,
(A) The drug or other substance has a ___
(B) The drug or other substance has a currently accepted medical
use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to___
less than the drugs or other substances in schedules I and
II. moderate or low physical dependence or high psychological
dependence.
Regarding CIV drugs,
(A) The drug or other substance has a ___
(B) The drug or other substance has a currently accepted medical
use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to___
low potential for abuse relative to the drugs or other
substances in schedule III. limited physical dependence or
psychological dependence relative to the drugs or other substances
in schedule III
Regarding CV drugs,
(A) The drug or other substance has a ___
(B) The drug or other substance has a currently accepted medical
use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited
physical dependence or psychological dependence relative to the drugs
or other substances in schedule IV
a low potential for abuse relative to the drugs or other
substances in schedule IV.
___ means a mechanical system that performs operations or activities,
other than compounding or administration, relative to the storage,
packaging, counting, labeling, and dispensing of medications, and
which collects, controls, and maintains all transaction information.
Automated dispensing system
___means a pharmacy which is permitted by the state in which it is
located to prepare controlled substances orders for dispensing
pursuant to a valid prescription transmitted to it by a registered
retail pharmacy and to return the labeled and filled prescriptions to
the retail pharmacy for delivery to the ultimate user.
Central fill pharmacy
Such central fill pharmacy shall be deemed �authorized� to
fill prescriptions on behalf of a retail pharmacy only if the retail
pharmacy and central fill pharmacy have a contractual relationship
providing for such activities or share a common owner.
___means any bottle, jar, tube, ampule, or other receptacle in which
a substance is held for distribution or dispensing to an ultimate
user, and in addition, any box or package in which the receptacle is
held for distribution or dispensing to an ultimate user
Commercial container
does not include any package liner, package insert or other
material kept with or within a commercial container, nor any carton,
crate, drum, or other package in which commercial containers are
stored or are used for shipment of controlled substances.
____means an individual practitioner, institutional practitioner,
pharmacy or pharmacist who dispenses a controlled substance
Dispenser
Dispenser are number of people. Can be nurses, physicians,
pharmacists.
____means a physician, dentist, veterinarian, or other individual
licensed, registered, or otherwise permitted, by the United States or
the jurisdiction in which he/she practices, to dispense a controlled
substance in the course of professional practice, but
does not include___
Individual practitioner
does not include a pharmacist, a pharmacy, or an
institutional practitioner (hospital or
institution).
T/F.
Individual practitioner
include a pharmacist, a pharmacy, or an institutional
practitioner (hospital or institution).
FALSE.
DO NOT INCLUDE
___means a hospital or other person (other than an individual)
licensed, registered, or otherwise permitted, by the United States or
the jurisdiction in which it practices, to dispense a controlled
substance in the course of professional practice, but does not include a pharmacy.
Institutional practitioner
___means all factory and branch stocks in finished form of a basic
class of controlled substance manufactured or otherwise acquired by a
registrant, whether in bulk, commercial containers, or contained in
pharmaceutical preparations in the possession of the registrant
(including stocks held by the registrant under separate registration
as a manufacturer, importer, exporter, or distributor).
Inventory
(Labeling/ Label)___means any display of written, printed, or graphic
matter placed upon the commercial container of any controlled
substance by any manufacturer of such substance.
Label
(Labeling/ Label)___
means all labels and other written, printed, or graphic matter
Labeling
___means a nursing home, retirement care, mental care or other
facility or institution which provides extended health care to
resident patients.
Long Term Care Facility (LTCF)
Mid-level practitioner such as___
nurse practitioners, nurse midwives, nurse anesthetists, clinical
nurse specialists and physician assistants who are authorized to
dispense controlled substances by the state in which they practice.
T/F. Mid-level practitioner means an
individual practitioner such as a physician, dentist, veterinarian,
or podiatrist, who is licensed, registered, or otherwise permitted by
the United States or the jurisdiction in which he/she practices, to
dispense a controlled substance in the course of professional practice
FALSE. These are NOT mild-level practitioner
Describe Controlled Substance Act regarding Symbols and Labeling?
the container must have some sort of label that indicates
the schedule
Each manufacturer shall print upon the labeling of each
controlled substance distributed
The word "schedule" should not be used. No
distinction made bw narcotic & non-narcotic
The symbol is not required on carton or
wrapper
The symbol is not required on commercial container that is
too small
What regarding the symbols for controlled substance?
prominently located on the label be clear and large
too see must be tamper-evident # from child-resistant
packaging
What are the role of symbols on control substance?
All control substances need to be designated with one of the
following symbols prominently displayed on the outside label:
�Schedule I, CI or C-I
What are the role of sealing on control substance?
All controlled substance needs �Tamper
Resistant Packaging� (ex: foil seal, shrink wrap) NOT
JUST Child Resistant packaging.
T/F. Everyone prescribing, distributing or dispensing controlled
substances needs to register with the DEA
TRUE
A separate registration is required for
each separate location. Except for 4 situations___
Warehouses that store drugs
An office used by the distributor
An office
used by practitioner
A satellite office used by an MD where he does NOT
dispense controlled substances of the same physical
building
Freight forwarding facility
T/F.
An employee of a business that has a DEA number does NOT need a
separate DEA number if the employee is �
acting in the usual course of his/her business or
employment�
TRUE
(ex: if CVS has a DEA #, a pharmacist working at that CVS does
NOT need a separate DEA# OR if a hospital has a DEA#, the hospital
pharmacist does not need a separate DEA#)
Give another exemption that doesn't require their own DEA?
If you have physical assistant, that one can dispense controlled
substances under your surpervision and the state allows it, then they
don�t have to get their own DEA number
Physician who works at a hospital that has a DEA# BUT who does NOT
have his own DEA# can still prescribe controlled substances IF he
meets the following 6 rules:___
KNOW THIS 6 RULES
Prescribing/dispensing is in the usual course of his/her
professional practice Authorized by the state
Hospital needs to verify that the physician is licensed to
prescribe/dispense/administer drugs Acting within the scope
of employment at the hospital or institution.
The hospital
authorizes the practitioner to dispense or prescribe under the
hospital registration # AND designates a specific INTERNAL CODE #
for each individual practitioner they authorize which is added on
as a suffix to the hospital DEA# preceded by a hyphen (e.g.
APO123456-A12) Hospital maintains a current list of
internal codes and corresponding practitioners
What are physical security controls for controlled substance?
Schedule I needs to be securely locked Schedule II,
III, IV, V should be securely locked. HOWEVER pharmacies may
disperse such substances throughout the stock of non-controlled
substances in such a manner as to obstruct
the theft or diversion of the controlled
substance
FROM HERE
HIGHLY TESTABLE AND CRITICAL
Who can issue a prescription for a controlled substance?
An individual practitioner (most often physician) who is:
Licensed
AND
Registered (w/the
DEA)
The prescription MAY
be communicated to the pharmacist by
an agent or employee of the individual practitioner (e.g. nurse,
technician, assistant) BUT the prescription MUST
originate from an individual
practitioner! If there is no physician involvement, the Rx is
considered VOID. The communication of the
prescription to the agent can be either written or oral If
there is a question about the prescription, the pharmacist should
ALWAYS refer back directly to the physician
What is the CORRECT order to dispense controlled substance?
Practitioner => Agent/ Employee => Pharmacist
When we call MD office for request, the agent/ receptionist puts you
on HOLD and comes back with a YES.
Is this act considered appropriate for controlled Rx?
NO.
The prescription doesn�t involve practitioner so it�s NOT allowed
What are 3 purposes to write a control prescriptions?
Must be issued for a
legitimate medical purpose by an individual practitioner acting
in the usual
course of his professional practice (ex. A podiatrist would
not normally write a C-II script for arm pain). Both the
prescribing practitioner and the PHARMACIST is responsible for the
proper prescribing and dispensing of controlled substances.
A
practitioner CANNOT write a prescription for �office stock� � He
can write out an order but NOT a prescription! A prescription
must be for an INDIVIDUAL.
A prescription
_may/ may not be issued in order for an
individual practitioner to obtain controlled substances for supplying
the individual practitioner for the purpose of general dispensing to patients
MAY NOT BE
=> You cant write a prescription for office stock
A prescription
may/may NOT be
issued for �detoxification treatment� or �maintenance treatment,�
May NOT be
unless the prescription is for a Schedule III, IV, or V narcotic
drug approved by the Food and Drug Administration specifically for use
in maintenance or detoxification treatment and the practitioner is in
compliance with requirements in �1301.28 of this chapter.
What info MUST BE present in the control prescription?
All prescriptions for controlled substances need to be dated as
of an signed on the �the date
issued� and must include:
Full name and
address of patient
Drug name,
strength, dosage form and quantity prescribed
Directions for
use
Name, address
and registration/DEA # of the practitioner
Paper prescription
MUST be HAND-SIGNED (no rubber stamp!) even if computer
generated. Electronic prescriptions need to be created and
signed using a specified application (discussed later)
A prescription for a Schedule III, IV, or V narcotic drug approved by
FDA specifically for "detoxification treatment" or
"maintenance treatment" must include ___
the identification number issued by the Administrator or
a written notice stating that the practitioner is acting under
the good faith exception
Where a prescription is for gamma-hydroxybutyric
acid, the practitioner shall ___
note on the face of the prescription the medical need of the
patient for the prescription.
A Rx for a controlled substance may ONLY be filled by a pharmacist
(licensed)who is:___ 3 conditions?
Acting in the usual course of his profession AND
Registered with the DEA individually OR Employed by a
registered pharmacy
Regarding CII,
A pharmacist can ONLY dispense a C-II if they are presented
with___
A written
prescription signed by the practitioner
An individual practitioner can fax you the Rx for convenience
(i.e. so you can get it ready) BUT you still CANNOT dispense it
until you receive the actual written prescription!
Regarding CII,
An individual practitioner can administer or dispense a C-II
directly w/o a prescription
TRUE/ FALSE?
TRUE
but it has to be in the course of his professional practice without
a prescription
Regarding CII,
An institutional
(hospital) practitioner can dispense (but NOT prescribe) a
C-II based on ___
either a
signed prescription OR
an order for
medication for immediate administration.
Regarding CII,
In the case of an EMERGENCY, a pharmacist can dispense a C-II
only based on ORAL authorization by a prescribing individual
practitioner IF:
4 CONTIDITONS
The prescribing
practitioner decides that it is an emergency situation
Immediate
administration of the C-II is necessary
There is no non-CII
alternative available
The physician is
unable to provide a written Rx to the dispensing
pharmacist.
Regarding CII, In the aforementioned EMERGENCY situation:
The quantity prescribed MUST be
___ Prescription needs to be reduced to
writing and have all the information as a regular prescription
EXCEPT ___ The prescribing practitioner must be ____
limited to a quantity required during the
emergency period (In PA this means enough drugs to last you 72
hrs.) the signature of the physician (naturally)
known to the pharmacist or there must be an attempt to look up
the practitioner and make sure he/she is legitimate.
T/F. Under emergency situation, pharmacists can dispense
C-II- Emergency, for a limited of
have 10 days supply or 15 or 30 day supply.
FALSE.
No emergency situations that will have 10 days supply or 15
or 30 day supply.
Regarding CII, In the aforementioned EMERGENCY
situation, The pharmacist must obtain an actual written
prescription for the emergency quantity BY___time & methods
Within 7 days
(federal)
(If the physician does not provide one in this time, the
pharmacist should contact the DEA)
It should have the phrase "Authorization for
Emergency Dispensing� written on it Both your written copy
based off the oral authorization and the actual written copy should
be attached together and kept on file
Under federal law (check the state law), you have ___to get written
prescriptions for emergency supply of control substance
7 days PA, 72 Hours
Regarding CII,
Central fill pharmacies
are/ are
NOT allowed to fill EMERGENCY C-II as long as
they're registered with DEA
NOT allowed
ALL C-II have to be written prescriptions, except for
3 EXCEPTIONS when
electronic/ fascimile prescriptions are acceptable
1) Have to do with immediate injection
2) Long Term Care facility
3) Hospice care program patient
Regarding CII,
A C-II that needs to be compounded for direct
administration or for a resident of a LTCF/hospice can NOT be sent
to the pharmacy via fax.
FALSE. Both Can be sent by fax
=> the fax serves as the original written prescription.
Regarding CII, in what 2 situations, , the fax serves as
the original written prescription?
C-II that needs to be compounded (
parenteral, intravenous, intramuscular, subcutaneous or
intraspinal
infusion) for direct administration can be
sent to the pharmacy via fax. A C-II for a resident of a
LTCF/hospice
certified and/or paid for by Medicare
Regarding CII,You (CAN/ CAN'T) REFILL a C-II!!!
CAN NEVER EVER EVER EVER
Regarding CII, a physician may however issue multiple Rx�s for a C-II
at one time provided that___
The prescriptions do not authorize the patient to receive more
than a total of a 90-day supply of the C-II
Each separate prescription is issued for a legitimate medical
purpose Every prescription other than the first one should be
post-dated (i.e
indicate the earliest date the pharmacy can fill the Rx)
CII CAN�T BE REFILLED.
If you have a prescription for 90 days, and the insurance only pays
for 30 mins. The patients have what options?
1)
Pay for the rest 60 pills
2)
Go with 30 pills and lose the rest. The prescription ends there
If you don�t have enough in stock, pharmacists ARE/ ARE NOT permitted
to partial fill
ARE permitted. however there are some rules to obey. Next slide
If you don�t have enough in stock, pharmacists ARE permitted to partial
fill. However,
1)Have to get the remaining in ___and get it ready within ___
2)Have to notify the physicians if the patients don�t get all the
amount ___. No more pills dispensed beyond ___
3)The patient however doesn�t have to get it ___
72 hours
Regarding CII, If the pharmacy does not have enough of the C-II drug
in stock, they can do a �partial fill� (NOT refills) provided that___
They record how much was actually supplied They can
supply the remaining quantity
within 72
hrs. If they cannot supply the remaining
quantity within
72 hrs,
the pharmacist must contact the prescriber who will have to issue a
brand NEW prescription. for patients who are in a
LTCF OR are deemed �terminally
ill�. However they must supply the remaining quantity
within 60 days.
Regarding CII, what are 7 info must have on Rx label
The date of filling Pharmacy name and address
Serial # of the prescription Name of the patient
Name of the prescribing practitioner Directions for
use Cautionary statements (if any)
T/F.
Central fill pharmacy
shall be deemed "authorized" to fill
controlled prescriptions on behalf of a retail pharmacy only if the
retail pharmacy and central fill pharmacy have a contractual
relationship providing for such activities or share a common owner.
TRUE
Regarding CII, is there any condition where CII does NOT have to be
labeled? If so, name one situation.
A C-II in a hospital does NOT
have to be labeled when dispensing LESS than a 7 day
supply of C-II
Regarding CII, how central fill pharmacy prepare orders for control substances?
A pharmacy which is
permitted by the state to prepare controlled substances orders for
dispensing pursuant to a valid prescription transmitted (can be
electronically or via fax) to it by a registered retail pharmacist
and to return the labeled and filled prescriptions to the retail
pharmacy for delivery to the ultimate user
Regarding CII, describe the steps how
retail pharmacists prepare control orders ultilizing
central fill?
Write the words �CENTRAL FILL� on the face of the original
paper Record the name, address & DEA # of the central
fill pharmacy the Rx is being sent to Record the name of
the retail pharmacist sending the Rx and the date it was sent.
Make sure all the information that needs to be on the Rx (see
C1in section I above) is sent.
Maintain the
original Rx for 2 years from the date of
filling. Keep a record of when the filled Rx
was received and who received it.
Regarding CII, describe the steps how Central Fill
Pharmacist
prepare control orders ultilizing central fill?
Keep a copy of the Rx including all the information that was
sent plus the name, address and DEA# of the retail pharmacy
Record the date when Rx was received and the name of the
pharmacist who filled the Rx and when he filled it. Keep a
record of when and how the filled Rx was delivered (tracking
label)
For how long retail pharmacists must maintain the original Rx for
control orders ultilizing central fill?
Maintain the original Rx for 2 years from the date of
filling.
Regarding CIII, IV,
& V,
In order to dispense C-III /IV/V, you can have either ___
An individual practitioner (can/ can NOT) administer /dispense
these drugs w/o a Rx. A hospital may dispense (but not
prescribe) these drugs if they have a have either a signed paper Rx,
a fax, an electronic Rx or an oral Rx reduced to writing by the
pharmacist OR ___dispensed for immediate
use.
a signed paper Rx, a fax, an electronic Rx or an oral Rx
reduced to writing by the pharmacist. CAN
a an order for medication
Regarding CIII, IV, & V,
what's the max refills & time we can refill them?
More than
5 times (even if the refill # on the Rx is
7 or 10)OR More than
6 months past the issue
date. Each refill needs to be
recorded
Regarding CIII, IV, & V,The prescribing physician (CAN/ CAN'T)
give an oral authorization of refills for
the original prescription
THEY CAN
Regarding CIII, IV, & V,
The prescribing physician can give an oral
authorization of refills for the original
prescription provided that___
The total quantity authorized including
the amount on the original Rx does not exceed
5 refills or 6 months past the date of
issue. All refills are adequately
recorded The quantity of each additional refill authorized is
not GREATER THAN the original quantity. (e.g. if the original Rx was
for 50 pills, the physician cannot verbally change the refill to 100
pills. He can however orally authorize a new Rx)
Regarding CIII, IV, & V,
If the patient doesn�t want the full # of pills on the
prescription, you must___ otherwise it will be assumed that the full
quantity was dispensed
mark it on the Rx
Regarding CIII, IV, & V, In a hospital, a
CIII/IV/V can be dispensed WITHOUT a label
IF not more than ___is dispensed a at one time.
a 34-day
supply OR 100 dosage units (whichever is less)
Regarding CIII, IV, & V, We can transfer them bw pharmacies
TRUE
Regarding CIII, IV, & V,
The transfer of a C-III/IV/V Rx between 2 �un-related�
pharmacies is permitted ___
on a one time basis only!
Regarding CIII, IV, & V,
Pharmacies that belong to the same chain and/or share a
�real-time, online database� may transfer up to___
the maximum # of refills permitted by law.
Regarding CIII, IV, & V,
The transfer must be between
____
2
licensed pharmacists
Regarding CIII, IV, & V, regarding requirements regarding
transferring bw 2 pharmacies,
Transferring pharmacists must__describe the steps
Write �VOID� on the face of the invalidated Rx (or record
transfer for electronic Rx) Record on the back of the
invalidated Rx:
Name, address & DEA# of the pharmacy Rx is being
transferred to. The name of the pharmacist transferring the
Rx and the name of the pharmacist receiving the Rx as well as the
date of transfer.
Regarding CIII, IV, & V, regarding requirements regarding
transferring bw 2 pharmacies,
Receiving pharmacists must__describe the steps
Write the word �transfer� on the face of the transferred
Rx. Reduce to writing all of the information required for a
Rx (Section I, C1)PLUS
Date of issue of original Rx Original prescription
#(if different) Original # of refills Date of
original dispensing # of valid refills remaining & date
and location of previous refills The name, address &
DEA # of the transferring pharmacy.
Regarding CIII, IV, & V, regarding requirements regarding
transferring bw 2 pharmacies,
The original and transferred Rx�s MUST be maintained for
____(last time your pharmacy refilled it � not another pharmacy)
2 years after the date of last refill
Regarding CIII, IV, & V,
If transferring 2 times, the third pharmacy needs to
record___
info from both the first and second pharmacies.