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Body: | Practitioner Diversion
Awareness Conference
Prescriptions for Controlled Substances
Loren Miller, Associate Section Chief
Liaison and Policy Section
The following presentation was accompanied by an oral
presentation on August 6 and 7, 2018, 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 requirements 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
§
Establish the meaning of a pharmacist's
corresponding responsibility.
21 C.F.R. § 1306.04(a)
§
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.
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.
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 oral emergency
schedule II prescription to a pharmacy for
the practitioner?
U.S. Drug Enforcement Administration
Diversion Control Division
First, to correct some 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 require that a practitioner
record diagnosis codes on prescription for a
controlled substance.
However, some states and insurance providers may
choose to impose such limits.
Dispelling Myth
U.S. Drug Enforcement Administration
Diversion Control Division
The DEA does NOT dictate what tests a
practitioner must conduct.
U.S. Drug Enforcement Administration
Diversion Control Division
Controlled Substance
Prescription Requirements
§
They must be issued by a DEA registered
practitioner. 21 C.F.R. § 1306.03(a)
**The signing of a prescription can not be
delegated**
§
Prescriptions 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
§
Prescriptions must be issued in the usual course of
professional practice. 21 C.F.R. 1306.04(a)
Controlled Substance
Prescription Requirements
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 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 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
§
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)
Preparing a Prescription
U.S. Drug Enforcement Administration
Diversion Control Division
§
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
Individual practitioners may 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 a 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 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)
§
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 was 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
§
Emergency controlled substances are drawn from
an emergency kit.
§
Prescriptions for patients in long term care
facilities (LTCFs) must be valid prescriptions
meeting all of the criteria of such prescriptions. The
prescriptions must also contain all the required
information including the quantity prescribed.
§
LTCFs cannot use medical orders in place of
prescriptions.
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 below information:
21 C.F.R. § 1306.21(a)
1.
Date
2.
Patient's Full Name
3.
Patient's Address
4.
Drug Name
5.
Drug Strength
Schedule III-V Prescriptions
U.S. Drug Enforcement Administration
Diversion Control Division
6.
Dosage Form
7.
Quantity Prescribed
8.
Directions of Use
9.
Name of Practitioner
10. DEA Registered
Address of Practitioner
11.Practitioner's DEA
Registration Number
Schedule III-V Prescriptions
U.S. Drug Enforcement Administration
Diversion Control Division
12. Practitioner's Signature (Unless Called
In)
13. Number of Refills
§
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 all the
above information to the pharmacist.
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:
21 C.F.R. § 1311.120(a)(9)
1.
Date of issuance
2.
Patient name
3.
Drug name, strength, form, quantity
prescribed, directions for use
4.
Name, address, DEA registration number of
practitioner
5.
Other information as applicable
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 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 a user name and password by
themselves.
§
The use of a biometric or hard token 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
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.
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 (LTCF)
can call in an oral emergency schedule II
prescription to a pharmacy 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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