___ is a prescription that is generated on an electronic application
and transmitted as an electronic data file
Electronic Prescription
Is encrypted and �locked� by the sender and the pharmacy has
the software or �key� to decrypt it. Was never paper! � NOT
the same thing as a fax or a PDF
__ is a company that sells you the software to be able to encrypt and
decrypt electronic Rx�s.
Application Service Provider
___ is the process used to verify the identity of the user.
This can be:
____ - a small electronic file usually on a USB or
____ - iris print, fingerprint, thumbprint to verify identity
(not really used in pharmacies but it is available)
Authentication Protocol
A physical �token� Biometric
____is a data record that tells you everything about that file. It contains:
____ - Creates the digital signature. For internal record
keeping. ____ - Verifies the digital signature. The sender of
the electronic Rx can share this with any pharmacy they want to
decode the Rx.
Digital Certificate
Private Key
Public Key
Describe how electronic prescription work?
In order for you to receive an electronic prescription, you need to
be in possession of an actual physical token(USB) that is inserted in
to the PC and then you can type in your user name and password to use
the software that gives you access to the electronic Rx.
Regarding requirements for Electronic Rx
An electronic Rx created by an application that does not meet
the requirements is ___ A controlled substance Rx created
by an application that is technically valid but has the security
features disabled is ___ All the same rules that apply to
paper Rx�s (e.g. can�t be written by a clown) also apply to
electronic ones!!!
NOT a valid Rx! also VOID.
T/F.
If the law requires that a notation needs to be made on a
paper prescription, a similar notation needs to be made
electronically
TRUE
What would you do if
If a physician calls in an electronic Rx AND also gives a
patient a written one
you can only fill one and you need to mark the other one as
VOID
Need to keep the record of the electronic Rx for ___
at least 2 years from the date of creation
or receipt
T/F.
If during the
transmission of an electronic submission, any part of the
transmission gets scrambled, altered or deleted, that Rx is VOID
(note: specific to electronic Rx)
TRUE
What would you do if
When you get an oral Emergency C-II Rx, the physician can
send an electronic Rx within 72 hrs in lieu of a written Rx
You since you can�t physically attach this to the Rx you
reduced to writing, you need to annotate the electronic record with
the original authorization and date of the oral order.
Regarding Internet Prescriptions,
Covering practitioner: a practitioner that conducts
a medical evaluation at the request of a regular practitioner who
has:___2 things
Conducted at least 1 in-person or telemedicine (�Skype�)
evaluation within the previous 24 months and Is temporarily
unavailable to conduct the evaluation of the patient
Regarding Internet Prescriptions,
T/F. We can't fill new prescriptions for Controlled substance via
the internet.
FALSE
Regarding Internet Prescriptions,
Filling New prescriptions for Controlled substances
via the internet CAN ONLY be done if:__ 3 THINGS
The pharmacy has previously dispensed a controlled substance to
the patient via �non-internet� means (i.e. written or electronic
Rx) Pharmacy contacts the physician who wrote the original Rx
about authorizing an internet Rx The Physician determines
that there is a legitimate need for the drugs.
Regarding Internet Prescriptions, what is an ONLINE PHARMACY?
A controlled substance requires a valid Rx for dispensing
Need special DEA
registration
Now it's ORDER FORMS DEA ORDER FORM 222 OR ELECTRONIC ORDER FORM FOR C-II
OK
There are only 2 ways you can get a C-II. They are___
1) an actual Rx or
2) an order form (if not for an individual patient)
What is the EXCEPTION that NOT require a DEA form 222?
Delivery of a C-II
from a central fill pharmacy to a retail pharmacy
is an EXCEPTION.
Who can order C-II�s via an order form?
A person registered with the DEA whose registration has not
been revoked or suspended (registrant) A person given
�power of attorney� by the registrant
Who can send/sell a C-II via response to a DEA 222?
DEA registrant (e.g. pharmacist) to another DEA registrant (e.g
physician ordering �office stock�)
If a pharmacy is going out of business, they can �sell off�
their C-II�s using a DEA form 222 If you want to return
C-II�s back to the supplier (overstock, past expiration date, etc.),
you can use a DEA form 222 to do this
What is the procedure for executing a DEA form 222?
They will have a serial # (so they can be tracked for fraud)
and have the name, address and DEA registration # of the
registrant. Need to be completed simultaneously in
TRIPLCATE by typewriter, ink or indelible pencil
(not erasable) Only one item can be entered per line and
each item must consist of a container of the same drug.
Need to note down �the last line completed�. So if you write
down �5�, there should be nothing written on line 6 Needs
to be signed by registrant or person w/ �power of attorney�
UNEXECUTED DEA form 222�s can be stored
in another location but must be available at your store during
inspection
DEA FORM 222 Need to be completed simultaneously in
TRIPLCATE by typewriter, ink or indelible pencil (not erasable).
What are the copies
and who we'll send them to?
Copies 1 and 2 are
sent to the supplier (supplier keeps copy 1 and forwards copy 2 to
the DEA)
Copy 3 must be
retained by the pharmacy
Regarding Procedures for filling a DEA form 222,
____must record quantity shipped and date of shipment on copies 1
and 2
Supplier
Regarding Procedures for filling a DEA form 222, If the supplier only
has a limited # of the C-II�s in stock, they ARE NOT ALLOWED TO
do a partial fill. T/F.
FALSE,
They can do a partial fill but there's a requirement for that.
Regarding Procedures for filling a DEA form 222, If the supplier only
has a limited # of the C-II�s in stock, they can do a partial fill as
long as they ship the rest___
within 60
days. The form is only valid for 60 days.
Regarding Procedures for filling a DEA form 222,
Supplier needs
to forward ___to the DEA
copy 2
Regarding Procedures for filling a DEA form 222,
___
needs to forward copy 2 to the
DEA
Supplier
Regarding Procedures for filling a DEA form 222,
___ needs to record quantity and date received
Purchaser
Regarding Procedure for endorsing DEA 222 (forwarding),
If a supplier cannot fill the order, they can___
forward it to someone else and all the responsibilities would
be passed on to the new supplier
If an �unacceptable form� is received by the pharmacy,
supplier shall___
attach copies 1 and 2 to copy 3 along with the statement
telling why it was �unacceptable�
Unacceptable forms cannot be �fixed�, they need to be
replaced with a new form
What happens if Lost DEA order forms (
unfilled order forms)?
If you fill the
form properly and you never receive the C-II�s because the order
form got �lost in the mail�, you need to execute ANOTHER form (in
triplicate) and attach a statement containing the serial # and
data of the lost form and saying that you never received the
C-II�s from the first form.
A copy of the
statement must be attached to both copies 1 and 2 of the new form
that you send to the supplier AND attached to copy 3 that you
keep.
If the supplier
later somehow receives the first form, they need to write �not
accepted� on the form and send copies 1 and 2 back to the
purchaser.
What you do if Stolen DEA order forms
Purchaser must report the theft to the DEA w/ the serial # of
the forms If you don�t know the serial #, you should report
the date or approximate date of issue. If you later find
the forms you thought were stolen, then you need to report that
too.
The purchaser needs to keep all copy 3�s of the DEA form 222
___ all other forms and retain them for___
SEPARATE from
at least 2 years.
What's the definition of
Certification Authority
CSOS
Digital Certificate
The segment of the DEA that has been
designated to be in charge of the electronic order forms
�Controlled Substance Ordering
System� the thing that �locks� or �unlocks�
the order form
Regarding electronic order form,
***Unlike a paper DEA order form 222, an electronic order
form can be used to order ____prescriptions as well as
non-controlled substances as long as you use stricter requirements
for C-II (one-stop shopping ;)***
C-III, C-IV and
C-V
Regarding electronic order form,
A registrant/person w/ power of attorney can sign and transmit
electronic orders provided that the technology provides:
Authentication and
Nonrepudiation (i.e. is able to verify the
sender identity)
Message Integrity (ensures that nothing is lost
or altered during transmission)
Regarding electronic order form,
DEA needs to identify that electronic orders are signed and
transmitted using
___
PKI (Public Key Infrastructure Technology)
Regarding electronic order form,
Supplier AND purchaser must keep all records of electronic
orders for ___ These records need to be easily retrievable and
readable.
2 years.
Regarding electronic order form,
The following data fields need to be included on an electronic
order form for schedule I and II substances:
A unique 9-digit
tracking # (last 2 digits of the year-x-6 other digits e.g.
14x-123456)
Purchaser�s DEA
#
Supplier�s DEA
#
Name of the
supplier
Address of the
supplier
Date the order was
signed
Name and strength of
controlled substance or NDC#
Quantity in single
package/container
# of
packages/container
Regarding electronic order form,
Eligibility to obtain a CSOS digital certificate include
DEA registrant/power of attorney When you are signing
up to become a registrant, you need to provide lots of documents (
e.g. govt issued ID�s, power of attorney form, subscriber agreement,
etc.) Need to safeguard key and report if it is
lost/stolen If the person that has power of attorney is
fired, quits or has his/her privileges revoked, this must be
reported to the DEA within 6 hours.
Regarding electronic order form,
If the person that has power of attorney is fired, quits or
has his/her privileges revoked, this must be reported to the
DEA ___
within 6 hours.
Regarding electronic order form,
Unlike paper forms,
when the purchaser sends the electronic form to the supplier, the
supplier can process the order (i.e. enter it into the computer
system) at any one of its locations (even if that location is
not registered) as long as they then send it to another
REGISTERED location for the actual filling.
TRUE/ FALSE
TRUE
Regarding electronic order form,
As with the paper DEA 222, the supplier can ship part of the
shipment as long as they ship the remainder in ___ The form
is only valid for___
60
days.
Regarding electronic order form,
Like paper, an electronic paper CAN be endorsed (forwarded) to
a different supplier.
FALSE,
they CAN'T be
Regarding electronic order form,
The supplier MUST for each electronic order filled, forward
either a copy of the electronic order or an electronic report of the
order in a format that the DEA specifies to the
DEA within___
WITHIN 2 BUSINESS DAYS.(sort of like copy 2 of the paper form)
Regarding electronic order form,
when the purchaser receives an �unaccepted� electronic order,
he/she needs to link the statement of non-acceptance to the original
order.
TRUE/ FALSE
TRUE
Neither the purchaser or supplier can �correct� a defective
order (no voids, mistakes, changes, invalidations, bad
transmissions) � a new one must be issued.
Regarding electronic order form,
The purchaser AND the
supplier need to keep all records of all
electronic orders placed (including all linked records and
statements) for ___
2 years.
Regarding Maintaining
Records in a Central Location, All records (financial statements,
shipping info, inventory details, C-II order forms, etc.) MUST be
available for inspection by the DEA for___
at least 2 years
Regarding electronic order form,
You can keep some of these records off-site at a central location,
BUT there are 2 types of records that must be maintained
physically at your store(registered location):___
Executed Order Forms
Inventories
T/F.
C-II�s can never be mixed with non-controlled
substances!!!
TRUE
There are 3 systems you can use to file your controlled substance prescriptions.
One file for C-II�s, a SEPARATE second file for C-III/IV/V�s
and a SEPARATE third file for non-controlled substances. In
this case, you___
do NOT need to specially mark the controls.
There are 3 systems you can use to file your controlled substance prescriptions.
One file for C-II�s and a SEPARATE second file for
non-controlled substances + C-III/C-IV/C-V�s. In this case
you___
the C-III/IV/V�s need to be specially marked with a red letter
�C� at least an inch tall in the lower right corner of the Rx so they
There are 3 systems you can use to file your controlled substance prescriptions.
One file for non-controlled substances and a SEPARATE second
file for C-II�s +C-III/IV/V. In this case,
you___
the C-III/IV/V�s ALSO need to be specially marked with a red
letter �C� at least an inch tall in the lower right corner of the Rx
so they can be �readily retrievable� from the C-II�s.
Regarding inventory,
An
initial inventory needs to be conducted of all
the controlled substances �on hand� on the date you first engage in
the manufacture, distribution, or dispensing of controlled
substances and at least
___
biennially (within 2 years) thereafter.
Regarding inventory,
For each controlled substance in the inventory, you need to include:
The name of the
drug
Each finished form
of the substance (e.g., 10-milligram tablet or 10-milligram
concentration per fluid ounce or milliliter)
The number of units
or volume of each finished form in each commercial container
(e.g., 100-tablet bottle or 3-milliliter vial) and
The number of
commercial containers of each such finished form (e.g. four
100-tablet bottles or six 3-milliliter vials).
Regarding inventory,
For C-II�s you need an EXACT count in your inventory.
For C-III/IV/V�s , an approximate count is OK
UNLESS ___
the container has MORE than 1000 pills � then you need
an EXACT count of those as well***.