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Body: | Practitioner Diversion
Awareness Conference
Prescriptions for Controlled Substances
Aziz Elkholy, Staff Coordinator
Liaison Section
The following presentation was accompanied by an oral presentation
on August 19 & 20, 2019, and does not purport to establish legal
standards that are not contained in statutes, regulations, or other
competent law. Statements contained in this presentation that are not
embodied in the law are not binding on DEA. Summaries of statutory
and regulatory provisions that are summarized in this presentation do
not purport to state the full extent of the statutory and regulatory
requirements of the cited statutes and regulations. I have no financial
relationships to disclose.
LEGAL DISCLAIMER
U.S. Drug Enforcement Administration
Diversion Control Division
This presentation is for educational purposes only. This presentation may not be further copied or
used, with the embedded images and videos, without an independent analysis of the application of
the Fair Use doctrine.
Fair Use
Under section 107 of the Copyright Act of 1976, allowance is made for "Fair Use" for purposes such
as criticism, comment, news reporting, teaching, scholarship, education and research.
Fair Use is a use permitted by the copyright statute that might otherwise be infringing. Any
potentially copyrighted material used in this presentation has been reviewed and found to be used in
a manner consistent with Fair Use. A completed Fair Use checklist is attached.
Fair Use Act Disclaimer
U.S. Drug Enforcement Administration
Diversion Control Division
§
Acknowledge some common myths and misconceptions about
controlled substance prescriptions and the DEA.
§
Explain the laws and regulations concerning valid controlled
substance prescriptions.
21 C.F.R. § 1306
§
Review the basic elements of controlled substance prescriptions
and the importance of each.
21 C.F.R. § 1306.03,04
Course Objectives
U.S. Drug Enforcement Administration
Diversion Control Division
§
Review the various forms that prescriptions can take and the
limits of each.
21 C.F.R. § 1306.08, 1311
§
Note the special circumstances surrounding prescribing controlled
substances for hospice patients, LTCF patients, and patients with
opioid use disorder.
§
Establish the meaning of a pharmacist's corresponding
responsibility.
21 C.F.R. § 1306.04(a)
Course Objectives
U.S. Drug Enforcement Administration
Diversion Control Division
Questions To Discuss
At the completion of this block of instruction you will be able to
answer the following questions:
1.
How many times can a prescription for a Schedule III-IV controlled
substance be refilled?
2.
Under federal law is a practitioner required to use electronic
controlled substance prescriptions?
U.S. Drug Enforcement Administration
Diversion Control Division
Questions To Discuss
3.
Can a Schedule II controlled substance prescription be
refilled?
4.
Federally, can a pharmacist refuse to fill a prescription for
a controlled substance for any reason?
5.
Can a nurse at a long term care facility (LTCF) call in an
emergency schedule II prescription to a pharmacy for the
practitioner?
U.S. Drug Enforcement Administration
Diversion Control Division
Common Myths and Misconceptions:
§
The DEA registration number is NOT required on
prescriptions for non-controlled substances.
§
DEA does NOT define or regulate the practice of
medicine.
Dispelling Myth
U.S. Drug Enforcement Administration
Diversion Control Division
§
The DEA does NOT instruct practitioners on what
type, or what strength of a Schedule II-V controlled
substance they can or must prescribe.
§
The DEA does NOT dictate how frequently a
practitioner must see a patient.
Dispelling Myth
U.S. Drug Enforcement Administration
Diversion Control Division
§
The DEA does NOT dictate what tests a practitioner
must conduct.
§
The DEA does NOT require that a practitioner record
diagnosis codes on prescription for a controlled
substance.
§
However some States and insurance providers may
choose to impose such requirements.
Dispelling Myth
U.S. Drug Enforcement Administration
Diversion Control Division
U.S. Drug Enforcement Administration
Diversion Control Division
Controlled Substance
Prescription Requirements
§
A controlled substance prescription must be issued by a
DEA registered practitioner. 21 C.F.R. § 1306.03(a)
§
A controlled substance prescription must be issued for a
legitimate medical purpose. 21 C.F.R. 1306.04(a)
Controlled Substance
Prescription Requirements
U.S. Drug Enforcement Administration
Diversion Control Division
§
A controlled substance prescription must be issued in the
usual course of professional practice. 21 C.F.R. 1306.04(a)
**The signing of a prescription can not be delegated**
Controlled Substance
Prescription Requirements
U.S. Drug Enforcement Administration
Diversion Control Division
"Where an oral order is not permitted, paper prescriptions shall
be written with ink or indelible pencil, typewriter, or printed on a
computer printer and shall be manually signed by the
practitioner. A computer-generated prescription that is printed
out or faxed by the practitioner must be manually signed." 21
C.F.R. § 1306.(d)
§
A controlled substance prescription cannot be signed by some
type of device that generates an electronic signature.
Preparing a Prescription
U.S. Drug Enforcement Administration
Diversion Control Division
§
A prescription may not be written to obtain office stock for
general dispensing.
21 C.F.R. 1306.04(b)
Controlled Substance
Prescription Requirements
U.S. Drug Enforcement Administration
Diversion Control Division
§
A prescription can take three forms:
§
1. Paper
§
2. Oral
§
3. Electronic
§
Each have their place, and each have their own restrictions.
Controlled Substance
Prescription Requirements
U.S. Drug Enforcement Administration
Diversion Control Division
§
Can be written, called in, or faxed to the pharmacy by the
practitioner or his/her agent. 21 C.F.R. § 1306.21(a)
§
A prescription must contain all of the following information before a
pharmacy can consider filling the prescription.
21 C.F.R. § 1306.05(a)
1.
Date
2.
Patient's Full Name
3.
Patient's Address
4.
Drug Name
5.
Drug Strength
6.
Dosage Form
Schedule II Prescriptions
U.S. Drug Enforcement Administration
Diversion Control Division
7.
Quantity Prescribed
8.
Directions of Use
9.
Name of Practitioner
10.
DEA Registered Address of Practitioner
11.
Practitioner's DEA Registration Number
12.
Practitioner's Signature (No Stamps)
§
No refills are authorized on Schedule II controlled substance
prescriptions.
21 C.F.R. § 1306.12(a)
Schedule II Prescriptions
U.S. Drug Enforcement Administration
Diversion Control Division
In 2007 the DEA published in the Federal Register a Final Rule
allowing:
Individual practitioners to issue multiple Schedule II
prescriptions which authorize patients to receive up to a 90-day
supply providing:
§
Each separate prescription is issued for a legitimate
medical purpose by an individual practitioner acting in the
usual course of professional practice.
21 C.F.R. § 1306.12(b)(1)(i).
Multiple Schedule II Prescriptions
U.S. Drug Enforcement Administration
Diversion Control Division
§
Written instructions on each separate prescription
indicate the earliest date it can be filled.
21 C.F.R. § 1306.12(b)(1)(ii)
§
Doing so does not cause undue risk of diversion by
patient.
21 C.F.R. § 1306.12(b)(1)(iii)
§
Doing so must be in compliance with all other elements
of the CSA and state laws
21 C.F.R. § 1306.12(b)(1)(iv)
Multiple Schedule II Prescriptions
U.S. Drug Enforcement Administration
Diversion Control Division
The Comprehensive Addiction and Recovery Act of 2016 (CARA),
Section 702, titled Partial Fills of Schedule II Controlled Substances.
amended Title 21, United States Code, Section 829
(21 U.S.C. § 829), by adding subsection (f), which states that a
"prescription for a controlled substance in schedule II may be
partially filled" at the request of the patient (e.g., ultimate user)
or...
Partial Filling of Prescriptions for
Schedule II controlled substances
U.S. Drug Enforcement Administration
Diversion Control Division
the prescribing practitioner if "not prohibited by State law"; if "the
prescription is written and filled in accordance with [21 U.S.C. § 829],
regulations prescribed by the Attorney General, and State law"; the
"total quantity dispensed in all partial fillings does not exceed the total
quantity prescribed" and the "remaining portions of a partially filled
prescription for a controlled substance in schedule II... shall be filled
not later than 30 days after the date on which the prescription is
written."
Partial Filling of Prescriptions for
Schedule II controlled substances
U.S. Drug Enforcement Administration
Diversion Control Division
Three criteria for a practitioner (not the pharmacy) to determine if
an emergency oral prescription for a Schedule II controlled substance
is warranted:
1.
That immediate administration of the controlled substance is
necessary, for proper treatment of the intended ultimate user; and
Emergency Oral Schedule II
Prescription
29 C.F.R. § 290.10
U.S. Drug Enforcement Administration
Diversion Control Division
2.
That no appropriate alternative treatment is available, including
administration of a drug which is not a controlled substance, and
3.
That it is not reasonably possible for the prescribing practitioner to
provide a written prescription to be presented to the person
dispensing the substance, prior to the dispensing.
U.S. Drug Enforcement Administration
Diversion Control Division
Emergency Oral Schedule II
Prescription
29 C.F.R. § 290.10
Important Note:
§
The prescription is limited to the quantity adequate
to treat the patient during the emergency period.
21 C.F.R. § 1306.11(d)(1)
U.S. Drug Enforcement Administration
Diversion Control Division
Emergency Oral Schedule II
Prescription
Step #1: Patient requires an Emergency Schedule II
prescription.
Step #2: Nurse Contacts the Practitioner.
Emergency Oral Schedule II
Prescription Process
U.S. Drug Enforcement Administration
Diversion Control Division
Step #3: The practitioner contacts the pharmacy.
21 C.F.R. § 1306.11(d) states "...upon receiving oral authorization of a
prescribing individual practitioner..."
The Practitioner is the only person who can make the phone call - not
the nurse, secretary, agent, best friend, mother, or anyone else.
Emergency Oral Schedule II
Prescription Process
U.S. Drug Enforcement Administration
Diversion Control Division
Step #4: The pharmacist reduces the prescription to writing.
21 C.F.R. § 1306.11(d)(2)
It must be reduced to writing, not maintained in the computer
system, as it represents a paper prescription.
U.S. Drug Enforcement Administration
Diversion Control Division
Emergency Oral Schedule II
Prescription Process
Required information which the pharmacist must reduced to writing
(21 C.F.R. § 1306.05(a)):
Date, Patient Full Name, Address, Drug Name, Strength, Dosage Form,
Quantity Prescribed, Directions of Use, Practitioner name, Address,
Registration number.
The practitioner determines the quantity, not the pharmacy.
U.S. Drug Enforcement Administration
Diversion Control Division
Emergency Oral Schedule II
Prescription Process
Step #5: The pharmacist must verify that he or she is talking to the
prescriber.
Title 21 CFR § 1306.11(d)(3) states "If the prescribing individual practitioner is
not known to the pharmacist, he must make a reasonable effort to determine
that the oral authorization came from a registered individual practitioner,
which may include a callback to the prescribing individual practitioner using
his phone number as listed in the telephone directory and/or other good faith
efforts to insure his identity"
U.S. Drug Enforcement Administration
Diversion Control Division
Emergency Oral Schedule II
Prescription Process
Step #6: The pharmacy contacts the long term care facility and
authorizes the emergency withdrawal from the emergency dispensing
kit.
The nurse can then remove the amount needed for the emergency for
dispensing to the patient.
U.S. Drug Enforcement Administration
Diversion Control Division
Emergency Oral Schedule II
Prescription Process
Step #7: The practitioner must fax or mail an original manually
signed prescription to the dispensing pharmacy within seven
days.
21 CFR § 1306.11(d)(4)
The prescription that is received from the practitioner must
have annotated "authorization for emergency dispensing."
21 CFR § 1306.11(d)(4)
The prescription that is received from the practitioner must
have annotated "the date of the oral order."
21 CFR § 1306.11(d)(4)
U.S. Drug Enforcement Administration
Diversion Control Division
Emergency Oral Schedule II
Prescription Process
Emergency Oral Schedule II
Prescription Process
Step #8: The prescription that was reduced to writing must be attached
by the dispensing pharmacist to the original signed prescription.
21 CFR § 1306.11(d)(4)
Step #9: If the practitioner does not provide the original prescriptions
the regulations require (Not Optional) the pharmacist to contact the
local DEA office.
21 CFR § 1306.11(d)(4)
U.S. Drug Enforcement Administration
Diversion Control Division
Can be written, called in, or faxed to the pharmacy by the
practitioner or his/her agent.
21 C.F.R. § 1306.21(a)
Must contain the 12 elements mentioned earlier, plus one
additional, refills if applicable.
21 C.F.R. § 1306.21(a)
Schedule III-V Prescriptions
U.S. Drug Enforcement Administration
Diversion Control Division
Original plus 5 refills are the maximum that can be
authorized.
21 C.F.R. § 1306.22(a)
When a practitioner or the practitioner's agent calls in
a prescription they must provide 12 elements to the
pharmacist. (excludes the signature)
21 C.F.R. §. 1306.21(a)
Schedule III-V Prescriptions
U.S. Drug Enforcement Administration
Diversion Control Division
The partial filling of a prescription for a controlled substance listed in
Schedule III, IV, or V is permissible, provided that:
a)
Each partial filling is recorded in the same manner as a refilling,
b)
The total quantity dispensed in all partial fillings does not exceed the
total quantity prescribed, and
c)
No dispensing occurs after 6 months from the date on which the
prescription was issued.
Partial Filling of Prescriptions for
Schedule III-V controlled substances
U.S. Drug Enforcement Administration
Diversion Control Division
U.S. Drug Enforcement Administration
Diversion Control Division
Electronic Prescriptions
21 C.F.R. § 1311 Subpart C
§
Electronic prescriptions for controlled substances are
voluntary under the DEA's regulations.
§
Manually signed paper prescriptions for controlled
substances, and oral prescriptions for controlled substances,
are still permitted. However, some insurance carriers and
states have now made the use of EPCS mandatory.
Electronic Prescriptions
U.S. Drug Enforcement Administration
Diversion Control Division
EPCS
U.S. Drug Enforcement Administration
Diversion Control Division
True electronic prescriptions are transmitted
as electronic data files to the pharmacy,
whose application imports the data file into
its database.
§
The application provider's system must be audited by
qualified independent third part or have the application
reviewed and certified by an approved certification body.
They will then issue the application provider with a report.
The application provider must provide you a copy of this
report.
21 C.F.R. § 1311.102(d)
Electronic Prescriptions
U.S. Drug Enforcement Administration
Diversion Control Division
§
This is critical to the security of EPCS. The ability to
sign EPCS can only be granted to individuals whose
identity has been confirmed.
Identity Proofing
U.S. Drug Enforcement Administration
Diversion Control Division
§
After the practitioner's identity is verified, they will
be issued a two-factor authentication credential.
§
Protects practitioners from misuse of credential and
from external threats.
Two-Factor Authentication
U.S. Drug Enforcement Administration
Diversion Control Division
§
Two-factors - two of the following:
§
Something you know - password, PIN
§
Something you have - separate hard token
§
Something you are - a biometric
Two-Factor Authentication
21 C.F.R. § 1311.115(a)
U.S. Drug Enforcement Administration
Diversion Control Division
§
A practitioner or agent may prepare the prescription for
review and signature by the practitioner.
21 C.F.R. § 1311.135(a)
§
Practitioner accesses a list of prescriptions for a single
patient.
21 C.F.R. § 1311.140(a)(1)
Signing an EPCS Prescription
U.S. Drug Enforcement Administration
Diversion Control Division
§
List displays the 12 elements for a schedule II controlled
substance, and the 13 elements (if refills are to be
authorized) for schedule III-V controlled substances.
21 C.F.R. § 1311.120(a)(9)
Signing an EPCS Prescription
U.S. Drug Enforcement Administration
Diversion Control Division
Signing an EPCS Prescription
U.S. Drug Enforcement Administration
Diversion Control Division
§
On the same screen is the statement "by completing the two-factor
authentication protocol at this time, you are legally signing
prescription(s) and authorizing transmission of the above information
to the pharmacy for dispensing."
21 C.F.R. § 1311.140(a)(3)
§
The practitioner chooses which prescriptions are ready to be signed.
21 C.F.R. § 1311.140(a)(2)
Signing an EPCS Prescription
U.S. Drug Enforcement Administration
Diversion Control Division
§
The Practitioner is prompted to complete a two-factor
authentication protocol.
21 C.F.R. § 1311.140(a)(4)
§
Completion of the two-factor authentication protocol is a
legal signature.
21 C.F.R. § 1311.140(a)(5)
§
Each prescription must be transmitted as soon as possible
after signature.
21 C.F.R. § 1311.170(a)
§
Each prescription must remain electronic; conversion to a
fax is NOT permitted.
21 C.F.R. § 1311.170(f)
Transmission
21 C.F.R. § 1311.170
U.S. Drug Enforcement Administration
Diversion Control Division
§
A faxed prescription
§
A prescription sent via email
§
An electronically transmitted picture of a prescription
What is not EPCS
U.S. Drug Enforcement Administration
Diversion Control Division
§
A system that allows the prescriber to "sign"
his/her name, or in some way attached a copy of
their signature.
§
A text message containing prescription
information.
What is also not EPCS
U.S. Drug Enforcement Administration
Diversion Control Division
The use of any one of the three authentication tools by itself.
What's NOT Acceptable
U.S. Drug Enforcement Administration
Diversion Control Division
Prescriptions for Hospice
and
Long Term Care (LTCF)
Patients
U.S. Drug Enforcement Administration
Diversion Control Division
Long Term Care
§
Title 21 C.F.R. § 1300.01(b)(25) states "Long Term Care Facility
(LTCF) means a nursing home, retirement care, mental care or
other facility or institution which provides extended health care
to resident patients.
§
Important Note:
Jails and correctional institutions are not long term care facilities.
U.S. Drug Enforcement Administration
Diversion Control Division
Long Term Care
§
Written, manually signed prescriptions for Schedule II
controlled substances can be sent by facsimile to the
pharmacy, but cannot be dispensed until the pharmacist has
the original manually signed paper prescription in their
possession; however . . .
21 C.F.R. § 1306.11(a)
U.S. Drug Enforcement Administration
Diversion Control Division
Long Term Care
§
There are exceptions for LTCF patients, hospice patients, and
terminally ill patients. These written, manually signed
prescriptions, when sent by facsimile, serve as originals.
21 C.F.R. § 1306.11(e)(f) & (g)
§
Schedule II prescriptions for terminally ill patients or LTCF
patients can not exceed 60 days from the date of issuance, and
allows partial fills during that entire period up to the limit of the
quantity authorized.
U.S. Drug Enforcement Administration
Diversion Control Division
Prescriptions Issued by
Qualified Practitioners
and Other Qualified
Practitioners
U.S. Drug Enforcement Administration
Diversion Control Division
§
Must contain all of the information as required on prescriptions for
schedule III-V controlled substances.
21 C.F.R. § 1306.05(a).
§
A prescription for a Schedule III, IV or V narcotic drug approved by
FDA specifically for "detoxification treatment" or "maintenance
treatment" must also include the unique identification number (X
number) issued by the DEA in addition to the DEA registration.
21 C.F.R. § 1306.05(b).
Opioid Treatment
U.S. Drug Enforcement Administration
Diversion Control Division
§
Practitioners must keep records of all prescriptions issued
for maintenance and detoxification. These are required
records, and all required records must be kept at the
practitioner's DEA registered location for a minimum of
two years.
U.S. Drug Enforcement Administration
Diversion Control Division
Opioid Treatment
U.S. Drug Enforcement Administration
Diversion Control Division
Pharmacist's Corresponding
Responsibility
§
Corresponding responsibility rests with the pharmacist who fills the
prescription.
21 C.F.R. § 1306.04 (a)
§
Pharmacists can refuse to fill a prescription for a controlled
substance for any reason.
Pharmacist's Corresponding
Responsibility
U.S. Drug Enforcement Administration
Diversion Control Division
§
The responsibility for the proper prescribing and dispensing of controlled substances
is upon the prescribing practitioner, but a corresponding responsibility rests with the
pharmacist who fills the prescription. An order purporting to be a prescription issued
not in the usual course of professional treatment or in legitimate and authorized
research is not a prescription within the meaning and intent of section 309 of the Act
(21 U.S.C. 829) and the person knowingly filling such a purported prescription, as
well as the person issuing it, shall be subject to the penalties provided for violations
of the provisions of law relating to controlled substances. 21 C.F.R. 1306.04(a)
Controlled Substance
Prescription Requirements
U.S. Drug Enforcement Administration
Diversion Control Division
§
A prescription may be prepared by the secretary or agent for the
signature of a practitioner, but the prescribing practitioner is
responsible in case the prescription does not conform in all essential
respects to the law and regulations. A corresponding liability rests
upon the pharmacist, . . who fills a prescription not prepared in the
form prescribed by DEA regulations. 21 C.F.R. § 1306.05(f)
§
A pharmacist has no authority to prepare a prescription in whole or
in part for the practitioner.
Preparing a Prescription
U.S. Drug Enforcement Administration
Diversion Control Division
Course Review
We reviewed:
Some common myths and misconceptions
The laws and regulations concerning valid controlled substance prescriptions
The basic elements of controlled substance prescriptions and their importance
The various forms that prescriptions can take and the limits of each
The special circumstances surrounding prescribing controlled substances for hospice
patients, LTCF patients, and patients with opioid use disorder
The meaning of a pharmacist's corresponding responsibility
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
1.
Schedule III-IV controlled substance
prescriptions can be refilled a maximum of
how many times?
A.
10 times
B.
5 times
C.
8 times
D. 3 times
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
2.
Under federal law a practitioner is required to
use electronic controlled substance
prescriptions.
A.
True
B.
False
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
3.
A Schedule II controlled substance
prescription can be refilled.
A.
True
B.
False
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
4.
Federally, a Pharmacist can refuse to fill a
prescription for a controlled substance for any
reason.
A.
True
B.
False
U.S. Drug Enforcement Administration
Diversion Control Division
Post Questions
5.
A nurse at a long term care facility can call in
an emergency oral schedule II prescription
for the practitioner.
A.
True
B.
False
U.S. Drug Enforcement Administration
Diversion Control Division
Thank You for your time
and attention !
U.S. Drug Enforcement Administration
Diversion Control Division
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