NEW TAMPER-RESISTANT
SECURITY PRESCRIPTIONS
Q-What are “tamper-resistant
security prescription” forms?
The tamper-resistant security prescription forms are specialized prescription
forms that have at least
ten required security features pursuant to Health and Safety Code section
11162.1. As of July 1, 2004,
the triplicate prescription forms, used for Schedule II controlled substances,
is being phased out with a
new tamper-resistant security prescription form that prescribers are required
to purchase from designated
security printers that have been approved by the Board of Pharmacy and
the Department of Justice. By
January 1, 2005, nearly all written controlled substance
(Schedule II – V)
prescriptions are required to be
on these forms.
Q-What is an approved “security printer”?
A security printer is a printing company that
has applied to and been approved by the Board of
Pharmacy and the Department of Justice to produce the
new tamper-resistant security prescription forms
for use by authorized prescribers. If the security
printer is not listed on the Board of Pharmacy website
at
http://www.pharmacy.ca.gov/app_sec_printers.htm, it
is not approved, and cannot legally print the new
security prescription forms.
Q-How do I find an approved security printer to order
the new tamper-resistant security prescription forms?
Visit the Board of Pharmacy website at http://www.pharmacy.ca.gov/app_sec_printers.htm,
choose a
printing company from the list of approved security
printers, and contact them directly to order the
new
prescription forms. Please have a copy of the prescriber’s
state license and DEA registration available
when you order. Prices differ and are set by each
printer. If a company you wish to use is not listed
on
the Board of Pharmacy website, it is not an approved
security printer and cannot legally print the new
tamper-resistant security prescription forms. Unapproved
printers can apply to the Board of Pharmacy
for approval by completing the application found
on our website at
http://www.pharmacy.ca.gov/security_printer.htm.
Q-Are triplicate prescription forms valid after July
1, 2004?
Yes, triplicate prescription forms are valid
through December 31, 2004. Prescribers can use
either the
triplicate prescription form or the new tamper-resistant
security prescription form during the phase in
period of July 1, 2004 through December 31, 2004
for Schedule II prescriptions. After January 1,
2005,
nearly all written controlled substance prescriptions
(Schedule II-V) must be on the new tamper-resistant
security prescription form. Fax and oral prescriptions
are still acceptable for Schedules III–V
controlled
substance prescriptions. However, a security feature
on the new security form prints VOID across the
face of the prescription when faxed, please use
a regular prescription form for faxed prescriptions.
Q-After January 1, 2005, what should prescribers
do with their unused triplicate prescription
forms?
Please return unused triplicates to the Department
of Justice, Triplicate Prescription Program,
4949
Broadway, Sacramento, California 95820 by certified
or registered mail for destruction. For more
information, please call (916) 227-4051.
Q-How long is a controlled substance prescription
valid?
Since January 1, 2004, prescriptions
for all controlled substances (Schedules II–V)
are valid for 6
months from the date written. Pharmacists can
disregard the 14-day restriction currently
printed on the
triplicate prescription form for Schedule II
drugs; it is no longer correct.
Q-Do I still have the option
of faxing or phoning in a prescription for
a Schedule III – V controlled
substance?
Yes, prescribers can fax or phone in a prescription
for a Schedule III – V
controlled substance.
However, a security feature on the new tamper-resistant
security prescription form prints VOID across
the face of the prescription when faxed, please
use a regular prescription form for faxed prescriptions.
Pharmacies will have to validate the faxed
prescriptions.
Q-Can prescribers
write a prescription for a non-controlled substance on the new tamper-resistant security
prescription forms?
Yes.
Q-Can a prescriber write a non-controlled and
a controlled substance prescription
on one tamperresistant security prescription form?
Yes, as long as 1) the prescriber
uses the security prescription blank
that comes preprinted
with the
statement “Prescription is void if the number of drugs prescribed
is not noted” and 2) the total
number of
drugs are written in the designated
space on the security prescription
form. See Health
and Safety
Code
section 11162.1, subdivision (a)(8).
Q-Can a prescription include more than
one controlled substance (Schedules
II - V) on
the same tamperresistant security prescription
form?
Yes, as long as 1) the prescriber
uses the security prescription blank
that comes preprinted
with the
statement “Prescription is void if the number of drugs prescribed
is not noted” and 2) the total
number of
drugs are written in the designated
space on the security prescription
form. See Health
and Safety
Code
section 11162.1, subdivision (a)(8).
Q-Can a Schedule II controlled substance
and a Schedule III controlled substance
be written
on
the same tamper-resistant security
prescription form?
Yes, as long as 1) the prescriber
uses the security prescription blank
that comes preprinted
with the
statement “Prescription is void if the number of drugs prescribed
is not noted” and 2) the total
number of
7/16/2004 Page 3 of 9 drugs are written in the designated
space on the security prescription
form. See Health
and Safety
Code section 11162.1 subdivision (a)(8).
Q-What replaces a skilled nursing
facility/hospice pharmacy-generated
triplicate prescription
form (SNF form)?
As of July 1, 2004, the pharmacy
can use a form of its own design
for those drug orders.
Q-Can a California
pharmacy fill a prescription for a Schedule II
controlled
substance that
was written
by an out-of-state prescriber
for an out-of-state patient? What about
Schedule III thru
V controlled substances?
Yes, so long as the prescription
conforms to the requirements
for controlled substance
prescriptions
in
the state in which the controlled
substance was prescribed. The prescription
must
be delivered to the
patient in the other state. Prescriptions
for Schedule II controlled substances
must be reported
to CURES
and effective January 1, 2005,
prescriptions for both Schedule
II and III must
be reported to CURES.
Q-Is a federal controlled substance
registration number the same
thing as a DEA registration number?
Yes
Q-With the triplicates, the
Department of Justice verified
that a prescriber
could write Schedule
II controlled substance prescriptions
prior to filling an order
for triplicate forms. How
does a pharmacist know that
a prescriber has the authority to write controlled
substance
prescriptions
using
the
new tamper-resistant security
prescription form?
Pursuant to Health and
Safety Code section 11161.5
et seq.,
the approved
security printer
is required
to
verify that the prescriber
ordering the new tamper-resistant
security
prescription forms,
holds a valid
unexpired license and has
the authority to write controlled
substance prescriptions
(any
or all
Schedules
II - V). If a pharmacist
is concerned that a prescriber
is not authorized
to specifically
write a Schedule
II
controlled substance prescription,
the board recommends that
the pharmacist ask the
prescriber to provide a copy of his or her DEA
registration, which lists
the schedules of
controlled substances
that he
or she is authorized to
prescribe.
Q-After January 1, 2005,
can a prescriber use
the Health
and Safety
Code section
11159.2
exemption for a terminally
ill patient to write a prescription
for any controlled
substance (Schedule II – V)
on a regular plain prescription
form as long as the prescriber
makes
the
notation “11159.2
exemption”?
No, only Schedule II
prescriptions for terminally
ill patients
can be written on a plain
prescription
form; there is no terminally
ill exemption for Schedule
III - V
controlled substances.
Effective
January
1, 2005, prescriptions
for Schedule III-V controlled
substances for
terminally ill patients
must
be either n
a tamper-resistant security
prescription form, telephoned,
or faxed in to
the pharmacy. The
intent of the
11159.2 exemption is
to make it easier for
terminally
ill patients
to obtain
strong pain
medication.
The
exemption applies to
Schedule II drugs, which
can be written
on
a plain prescription
form
with the
notation “11159.2 exemption”.
Q-It appears that a pharmacist’s
ability to correct
an error or errors on a Schedule
II prescription is
eliminated on January 1, 2005, is that true? 7/16/2004
Page 4 of 9
No, as of July 1,
2004, Health and Safety
Code
section 11164,
subdivision (a)(5)
allows a pharmacist
to fill a Schedule
II prescription containing
errors if the
pharmacist notifies
the
prescriber of the
errors
and the prescriber
approves any correction.
The prescriber
must
fax or mail a
corrected prescription
to
the pharmacist within
7 days of the drug
being dispensed.
As of
January
1, 2005, a Schedule
II
prescription containing
errors should be handled
as any
other prescription
that is uncertain,
unclear,
and/or ambiguous: the
pharmacist must contact
the prescriber
to obtain the
information to
validate the
prescription (Title
16 of the California
Code
of Regulations
section 1761,
subdivision (a).)
Q-Do prescriptions
for all controlled
substances
have
to be entirely
in the prescriber’s
handwriting?
No, the prescriber
is only required
to sign and date
controlled substance
prescription,
with limited
exceptions.
Q-Who can authenticate
a controlled substance
prescription?
For
example, verify
a stamped signature, verify a prescription
that appears to
be copy, verify
a typewritten
date on a controlled
substance prescription,
or verify the source
of new faxed-in
prescription.
Pharmacists using
their professional
judgment
and training are
responsible for
interpreting and
evaluating a prescription.
However, at a pharmacist’s
direction a pharmacy
employee may contact
the
prescriber’s
office to verify/clarify
non-clinical
information
contained on
a prescription;
for example, is
the fax/phone number
that of the prescriber?
Of course,
a telephoned
prescription
must be received
only
by a pharmacist
or pharmacist intern
(under the supervision
of the pharmacist).
The pharmacist
is
responsible for
the accuracy of
all information
on
the prescription
documents and the
prescription
medication dispensed.
Q-If a prescriber
has several offices,
can
he or she order
the new tamper-resistant
security
prescription
forms preprinted with all of the
addresses listed?
Yes, multiple
addresses for
one prescriber
may be listed
on the
form. The forms
may include a
check
box or some other
means to identify
the specific
address
where the
patient was seen.
Q-Can a prescriber
purchase stock
prescription
blanks for
a laser
or dot matrix
printer that
comes with
all of the security features
except
for the preprinted
prescriber
name, category
of licensure,
DEA number
and state license number.
No, the preprinted
prescriber
information
is one of the
security features
and therefore,
must be
provided by
an approved
security
printer.
However, an
approved security
printer
could offer
for sale
tamper-resistant
security prescription
blanks
designed for
laser or
dot matrix
printers as
long as they
are
preprinted
with the prescriber
information
before shipping
to the prescriber.
The prescriber
could then
send the patient
and prescription
information
electronically
to print on
the laser prescription
blank.
The
prescriber
must the sign
and
date the
prescription.
Note: Although
the prescriber
address
is not required
to be printed
on the prescription
form by the
approved security
printer, the
pharmacist
cannot fill
the prescription
without
the prescriber
address on
the
form. Therefore,
the board recommends
that
prescribers’ order
the new tamper-resistant
security
prescription
forms with
the address
printed on
the form.
Multiple addresses
are acceptable.
Back to top
ORAL AND FAXED
PRESCRIPTIONS
Q-Can a prescriber
call in or
send a fax
prescription
for Schedule
III – V
controlled
substances?
Yes. For
prescriptions
called in
to the pharmacist,
the
pharmacist
must reduce
the prescription
to hard
copy form
using a
form of
the
pharmacy’s
own design,
and sign
and date
the prescription
in
ink. For
faxed prescriptions,
the pharmacist
must produce
the prescription
in hard copy
form,
and sign
and date
the prescription
in ink.
Note: One
of the
security
features
on the
new tamper-resistant
prescription
forms will
print “void” across
the face of the security prescription
when faxed or copied,
prescribers are encouraged to use
a regular
prescription
form when
faxing prescriptions.
Q-Can a prescriber
call in
or send a fax
to a
pharmacy
for a Schedule
II controlled
substance?
No, with
two exceptions.
A
licensed
skilled
nursing
facility,
licensed
intermediate
care
facility,
licensed
home health
agency
or licensed
hospice
can call
in an
order or
send a
fax prescription
for
Schedule
II - V
controlled
substances.
The pharmacist
must reduce
the
prescription
to hard
copy on
a
form of
the pharmacy’s
own design
or produce
the fax
in hard
copy
form,
and in
both instances,
must
sign and
date the
prescription.
(Health
and Safety
Code, section
11167.5.)
The other exception
is for
an emergency
where
loss of
life or
intense
suffering
may occur
by not
issuing
the prescription pursuant
to Health
and
Safety
Code section
11167.
In this
instance,
the prescriber
maycall
in or fax
the prescription
to the
pharmacy.
The pharmacist
must
reduce
the
telephoned
prescription
to hard
copy form,
or
produce
the fax
in hard
copy
form, and
in both
instances,
sign and
date the
prescription.
The prescriber
must, within
7 days,
provide
a written
prescription
on the
new
tamperresistant
security prescription
form (or
triplicate
form between
July 1,
2004 and
December
31, 2004).
The pharmacist
must notify
the Bureau
of Narcotic
Enforcement
within
144 hours
of
a prescriber’s
failure
to do so,
including
the date
and method
of notification.
Q-Can a
prescriber’s
staff
person
call
in or
send
a fax
for a
Schedule
III – V
prescription?
Yes,
however,
the prescription
must
include
the name
of the
person
calling
in or
faxing
the
prescription.
A pharmacist
or pharmacist
intern
must
receive
a
telephone
order.
In addition,
the
pharmacist
must
authenticate
the validity
of the
prescription.
Back
to top
LICENSED
HEALTH
CARE
FACILITIES
Q-Can
a licensed
skilled
nursing
facility,
licensed
intermediate
care
facility,
licensed
home
health
agency,
or
licensed
hospice
call
in
or
fax
a
Schedule
II
controlled
substance
order
for
a
patient?
What
if the
patient
is
being
discharged
and
wants
to
pick
up
the
prescription
on
the
way
home
at
the
pharmacy?
An
order
for
a Schedule
II
controlled
substance
for
a
patient
of
a licensed
skilled
nursing
facility,
licensed
intermediate
care
facility,
licensed
home
health
agency,
or
a licensed
hospice
can
be
phoned
in
or
faxed
pursuant
to
Health
and
Safety
Code
section
11167.5.
Phoned
in
orders
must
be
reduced
to
hard
copy
and
signed
and
dated
by
the
pharmacist.
Faxed
orders
must
be
produced
in
hard
copy
form,
and
signed
and
dated
by
the
pharmacist.
The
prescription
must
include
the
signature
of
the
person
receiving
the
controlled
substance
prescription
on
behalf
of
the
facility.
The
facility
must
forward
a copy
of
any
signed
telephone
orders,
chart
orders,
or
related
documentation
to
the
pharmacist.
Discharged
patients
receive
a written
prescription
as
outpatients;
therefore,
the
prescription
must
be
written
on
the
new
tamper-resistant
security
prescription
form
or
the
triplicate
form
from
July
1,
2004
through
December
31,
2004.
After
January
1,
2005,
the
order
must
be
written
on
the
new
tamperresistant security
prescription
form.
Q What
is
an “institution” form
for
a
qualified
licensed
health
care
facility?
A
licensed
health
care
facility
has
the
option
of
designating
a
prescriber
to
represent
the
health
care
facility.
The
designated
prescriber’s
name,
state
license
number,
category
of
licensure,
and
DEA
number
are
preprinted
on
the
prescription
form
along
with
the
facility
name,
address,
state
license
number,
and
category
of
licensure.
The
form
also
includes
a
blank
space
for
the
actual
prescriber
to
handwrite,
type,
or
stamp
his
or
her
name,
state
license
number,
category
of
licensure,
and
DEA
number.
The
forms
are
delivered
to
the
designated
prescriber
who
is
responsible
for
distributing
the
prescription
forms
to
prescribers
authorized
within
the
facility.
The
designated
prescriber
must
maintain
a
record
that
includes
the
name,
category
of
licensure,
state
license
number,
DEA
number,
and
the
quantity
of
forms
issued
to
each
prescriber
and
maintain
the
record
in
a
readily
retrievable
format
for
3
years.
The
designated
prescriber
may
delegate
any
or
all
of
these
tasks
to
staff;
however,
the
designated
prescriber
will
be
held
accountable
for
compliance
with
these
requirements.
The
board
recommends
that
the
prescriber
also
record
the
batch/lot
numbers
of
the
forms
distributed.
(Health & Safety
Code
section
11162.1,
subdivision
(c).)
Back
to top
CALIFORNIA
UTILIZATION, REVIEW,
AND EVALUATION
SYSTEM (CURES)
Q-What is
CURES?
A
The Department
of Justice,
Bureau of
Narcotics Enforcement
maintains the
California Utilization,
Review
and Evaluation
System (CURES)
for the
electronic monitoring
of the
prescribing and
dispensing
of
Schedule II
controlled substances
dispensed to
patients in
California pursuant
to Health
and Safety
Code
section 11165.
The CURES
database captures
data from
all Schedule
II controlled
substance
prescriptions
filled as
submitted by
pharmacies, hospitals,
and dispensing
physicians. Beginning
January
1,
2005, CURES
will capture
Schedule III
data as
well. Law
enforcement and
regulatory agencies
use the
data
to assist
in their
efforts to
control the
diversion and
resultant abuse
of Schedule
II and
III drugs.
Prescribers
and pharmacists
may request
a patient’s
history of controlled
substances dispensed
in
accordance
with guidelines
developed by
the Department
of Justice.
Q-Who is
required to
report to
CURES?
All dispensing
pharmacies authorized
to dispense
Schedule II
drugs are
required to
report to
CURES
in
a frequency
and format
specified by
the Department
of Justice,
Bureau of
Narcotic Enforcement
(BNE).
BNE requires
pharmacies to
submit data
in an
electronic format
by the
18th of
every month,
the
data
collected from
the previous
month. Beginning
January 1,
2005, both
Schedule II
and III
prescriptions
filled must
be reported
to CURES.
The BNE
directs pharmacies
to contact
the CURES
data
collection
vendor, Atlantic
Associates, at
1-888-492-7341 for
information on
how to
submit data.
As
of July
1, 2004,
physicians that
dispense Schedule
II drugs
from their
offices directly
to patients
must
report
to CURES
in hard
copy or
in an
electronic format,
and beginning
January 1,
2005, all
Schedule III
drugs
dispensed must
also be
reported. Dispensing
physicians should
contact the
Department of
Justice,
Bureau
of Narcotic
Enforcement, at
(916) 227-4051
for more
information.
Q-How does
a pharmacy
submit data
to the
CURES system?
The Department
of Justice,
Bureau of
Narcotic Enforcement
specifies pharmacies
to submit
data for
the
previous month
to CURES
no later
than the
18th of
every month.
Pharmacies must
report
electronically
or via
disk accompanied
by a
completed CURES
Program Transmittal
form. Pharmacies
are
required to
report even
if they
did not
fill any
Schedule II
prescriptions; reported
as zero
on the
CURES
Program Transmittal
form. BNE
directs pharmacies
to contact
the data
collection vendor,
Atlantic
Associates, toll
free at
1-888-492-7341 for
more detailed
information and
data format
specifications.
Q-How does
a prescriber
or pharmacist
request a
patient history
of controlled
substances prescriptions from
the CURES
system?
A prescriber
or pharmacist
can download
a Patient
Activity Report
(PAR) request
form by
visiting the
Board
of Pharmacy
website at
https://www.dca.ca.gov/pharmacy/secure/pharmacy_forms_request.htm.
Complete
the appropriate
PAR form
and fax
it to
the Department
of Justice,
Bureau of
Narcotic
Enforcement
at (916)
227-5079.
Q-Do I
need to
enter the
batch/lot number
on the
new tamper-resistant
security prescription
form into CURES?
No, the
batch/lot number
is not
tracked by
the State.
The batch
number is
not reported
to the
CURES
system.
Prescribers might
consider using
the batch
number to
track their
forms internally
for inventory
purposes,
and security
printers might
consider using
the number
to account
for forms
during the
production
process.
Q-Can a
physician have
more than
one DEA
number?
Yes. A
physician who
administers or
|