Prescriptions
Long Term Care Facility (LTCF)
Records / Reports
Security
Prescriptions
Question: What is a prescription?
Answer:
A prescription is an order for medication which
is dispensed to or for an ultimate user. A prescription is not
an order for medication which is dispensed for immediate
administration to the ultimate user (e.g., an order to
dispense a drug to an inpatient for immediate administration
in a hospital is not a prescription). To be valid, a
prescription for a controlled substance must be issued for a
legitimate medical purpose by a registered practitioner acting
in the usual course of sound professional practice.
Question: What information is required on a prescription for
a controlled substance?
Answer: A prescription for a controlled substance must
include the following information:
- Date of issue;
- Patient’s name and address;
- Practitioner’s name, address, and DEA registration
number;
- Drug name;
- Drug strength;
- Dosage form;
- Quantity prescribed;
- Directions for use;
- Number of refills (if any) authorized; and
- Manual signature of prescriber.
A prescription must be written in ink or indelible pencil or
typewritten and must be manually signed by the practitioner. An
individual may be designated by the practitioner to prepare the
prescriptions for his/her signature. The practitioner is
responsible for making sure that the prescription conforms in
all essential respects to the law and regulation.
Prescriptions for schedule II controlled substances must be
written and be signed by the practitioner. In emergency
situations, a prescription for a schedule II controlled
substance may be telephoned to the pharmacy and the prescriber
must follow up with a written prescription being sent to the
pharmacy within seven days. Prescriptions for schedules III
through V controlled substances may by written, oral or
transmitted by fax.
Question: Can controlled substance prescriptions be refilled?
Answer: Prescriptions for schedule II controlled
substances cannot be refilled. A new prescription must be
issued. Prescriptions for schedules III and IV controlled
substances may be refilled up to five times in six months.
Prescriptions for schedule V controlled substances may be
refilled as authorized by the practitioner.
Question: Can controlled substance prescriptions for hospice
patients be faxed to a pharmacy?
Answer: A prescription written for a schedule II narcotic
substance for a patient enrolled in a hospice care program
certified and/or paid for by Medicare under Title XVIII or a
hospice program which is licensed by the state may be
transmitted by the practitioner or the practitioner’s agent to
the dispensing pharmacy by facsimile.
A pharmacist may dispense directly a controlled substance
listed in schedules III, IV, or V pursuant to either a written
prescription signed by a practitioner or a facsimile of a
written, signed prescription transmitted by the practitioner or
the practitioner’s agent to the pharmacy or pursuant to an
oral prescription made by an individual practitioner and
promptly reduced to writing by the pharmacist.
Question: Is it appropriate to provide a
DEA registration number on prescriptions written for medications
other than controlled substances?
Answer: DEA strongly opposes the use of a DEA
registration number for any purpose other than the one for which
it was intended, to provide certification of DEA registration in
transactions involving controlled substances. The use of DEA
registration numbers as an identification number is not an
appropriate use and could lead to a weakening of the
registration system. Although DEA has repeatedly made its
position known to industries such as insurance providers and
pharmacy benefit managers, there is currently no legal basis for
DEA to prevent or preclude companies from requiring or
requesting a practitioner’s DEA registration number.
The Centers for Medicare and Medicaid Services has developed
a National Provider Identification (NPI) number unique to each
healthcare provider. The Final Rule for establishment of the NPI
system was published in the Federal Register (FR 3434, Vol. 69,
No. 15) by the Department of Health and Human Services on
January 23, 2004. The effective date of this Final Rule was May
23, 2005; all covered entities were to begin using the NPI in
standard transactions by May 23, 2007. A contingency extension
was provided to covered entities unable to meet the 2007
deadline. Contingency plans were to not extend beyond May 23,
2008.
Question: Is it permissible to
dispense a prescription for a quantity less than the face amount
prescribed resulting in a greater number of dispensations than
the number of refills indicated on the prescription?
Answer: Yes. Partial refills of schedules III and IV
controlled substance prescriptions are permissible under federal
regulations provided that each partial filling is dispensed and
recorded in the same manner as a refilling (i.e., date refilled,
amount dispensed, initials of dispensing pharmacist, etc.), the
total quantity dispensed in all partial fillings does not exceed
the total quantity prescribed, and no dispensing occurs after
six months past the date of issue.
Question: What changes may a
pharmacist make to a prescription written for a controlled
substance in schedule II?
Answer: On November 19, 2007, the DEA published in the
Federal Register (FR) the Final Rule entitled Issuance of
Multiple Prescriptions for Schedule II Controlled Substances
(72 FR 64921). In the preamble to that Rule, DEA stated
that "the essential elements of the [schedule II]
prescription written by the practitioner (such as the name of
the controlled substance, strength, dosage form, and quantity
prescribed)…may not be modified orally."
Question: What changes may a
pharmacist make to a prescription written for a controlled
substance in schedules III-V?
Answer: The pharmacist may add or change the patient’s
address upon verification. The pharmacist may add or change the
dosage form, drug strength, drug quantity, directions for use,
or issue date only after consultation with and agreement of the
prescribing practitioner. Such consultations and corresponding
changes should be noted by the pharmacist on the
prescription. Pharmacists and practitioners must comply
with any state/local laws, regulations, or policies prohibiting
any of these changes to controlled substance prescriptions.
The pharmacist is never permitted to make changes to the
patient’s name, controlled substance prescribed (except for
generic substitution permitted by state law) or the prescriber’s
signature.
Question: Can a practitioner
prescribe methadone for the treatment of pain?
Answer: Federal law and regulations do not restrict the
prescribing, dispensing, or administering of any schedule II,
III, IV, or V narcotic medication, including methadone, for the
treatment of pain, if such treatment is deemed medically
necessary by a registered practitioner acting in the usual
course of professional practice.
Confusion often arises due to regulatory restrictions
concerning the use of methadone for the maintenance or
detoxification of opioid addicted individuals, in which case the
practitioner is required to be registered with the DEA as a
Narcotic Treatment Program (NTP).
Question: Can an individual return
his/her controlled substance prescription medication to a
pharmacy?
Answer: No. An individual patient may not return his/her
unused controlled substance prescription medication to the
pharmacy. Federal laws and regulations make no provisions for an
individual to return the controlled substance prescription
medication to a pharmacy for further dispensing or for disposal.
There are no provisions in the Controlled Substances Act or Code
of Federal Regulations (CFR) for a DEA registrant (i.e., retail
pharmacy) to acquire controlled substances from a non-registrant
(i.e., individual patient).
The CFR does have a provision for an individual to return
his/her unused controlled substance medication to the pharmacy
in the event of the controlled substance being recalled or a
dispensing error has occurred.
An individual may dispose of his/her own controlled substance
medication without approval from DEA. Medications should be
disposed of in such a manner that does not allow for the
controlled substances to be easily retrieved. In situations
where an individual has expired, a caregiver or hospice staff
member may assist the family with the proper disposal of any
unused controlled substance medications.
Long Term Care Facility (LTCF)
Question: Can controlled substance
prescriptions for a resident of an LTCF be faxed to a
pharmacy?
Answer: Yes. Schedules II-V controlled substance
prescriptions may be transmitted by the practitioner or the
practitioner’s agent to the dispensing pharmacy by facsimile.
The facsimile serves as the original written prescription.
Question: Can an LTCF store controlled
substances in an emergency kit without being registered with DEA?
Answer: DEA published the following Statement of Policy
in the April 9, 1980 Federal Register regarding the placement of
controlled substances in an emergency kit located in an LTCF.
STATEMENT OF POLICY
The placement of emergency kits containing controlled
substances in non-federally registered Long Term Care
Facilities (LTCF) shall be deemed to be in compliance with the
Comprehensive Drug Abuse Prevention and Control Act of 1970, if
the appropriate state agency or regulatory authority
specifically approves such placement and promulgates
procedures which delineate:
A. The source from which an LTCF may obtain controlled
substances for emergency kits. The source of supply must be a
DEA registered hospital/clinic, pharmacy, or
practitioner.
B. Security safeguards for each emergency kit stored in the
LTCF which include the designation of individuals who may have
access to the emergency kits and a specific limitation of the
type and quantity of controlled substances permitted to be
placed in each emergency kit.
C. Responsibility for proper control and accountability of
such emergency kits within the LTCF to include the requirement
that the LTCF and the providing DEA registered
hospital/clinic, pharmacy, or practitioner maintain complete
and accurate records of the controlled substances placed in
the emergency kit, the disposition of these controlled
substances plus the requirement to take periodic physical
inventories.
D. The emergency medical conditions under which the
controlled substances may be administered to patients in the
LTCF to include the requirement that medication be
administered by authorized personnel only as expressly
authorized by an individual practitioner and in compliance
with the provisions of 21
CFR 1306.11 and 21
CFR 1306.21.
E. Prohibited activities which can result in the state
revocation, denial, or suspension of the privilege of having
or placing emergency kits, containing controlled substances,
in an LTCF.
Question: Can an LTCF return a resident’s
unused controlled substance medication to a pharmacy?
Answer: No. There are no provisions in the Controlled
Substances Act for a DEA registrant (i.e., retail pharmacy) to
acquire controlled substances from a non-registrant (i.e.,
resident of an LTCF). Most LTFCs are not licensed by their
respective state to handle controlled substances and,
therefore, are not registered with DEA. LTCFs act in a
custodial capacity, holding controlled substances that,
pursuant to a prescription, have been dispensed to and belong
to the resident of the LTCF. Federal laws and regulations make
no provisions for controlled substances that have already been
dispensed to patients, regardless of the packaging method, to
be returned to a pharmacy for further dispensing or disposal.
Question: Can a patient in an LTCF
receive methadone for maintenance purposes?
Answer: If the LTCF is registered with DEA as a
hospital/clinic, it need not be separately registered as a
Narcotic Treatment Program (NTP) to administer or dispense
methadone as an adjunct to medical treatment of conditions
other than addiction. [21
CFR 1306.07(c)]
If an LTCF that is not registered with DEA has a patient
who is also currently enrolled in a licensed NTP, the NTP may
transfer medication to the LTCF with the approval of the State
Methadone Authority. (www.samhsa.gov/centers/csat/content/opat/statemeth.html)
If an individual is not currently enrolled in an NTP and is
in an LTCF that is not registered with DEA, a practitioner may
administer narcotic drugs to the individual for relieving
acute withdrawal symptoms when necessary while arrangements
are being made for referral for treatment. No more than one
day’s medication may be administered to the individual or
for the individual’s use at one time. Such emergency
treatment may be carried out for no more than three days and
may not be renewed or extended. [21
CFR 1306.07(b)]
Records / Reports
Question: What is meant by "readily retrievable?"
Answer:
The term "readily retrievable" means
the record is kept or maintained in such a manner that it can
be separated out from all other records in a reasonable time
or that it is identified by an asterisk, redline, or some
other identifiable manner such that it is easily
distinguishable from all other records.
Question: Is a practitioner required to keep records?
Answer: Each practitioner must maintain inventories and
records of controlled substances listed in schedule II
separately from all other records maintained by the registrant.
Likewise, inventories and records of controlled substances in
schedules III, IV, and V must be maintained separately or in
such a form that they are readily retrievable from the ordinary
business records of the practitioner. All records related to
controlled substances must be maintained and be available for
inspection for a minimum of two years.
A registered practitioner is required to keep records of
controlled substances that are dispensed to the patient, other
than by prescribing or administering, in the lawful course of
professional practice. A registered practitioner is not required
to keep records of controlled substances that are prescribed in
the lawful course of professional practice, unless such
substances are prescribed in the course of maintenance or
detoxification treatment. A registered practitioner is not
required to keep records of controlled substances that are
administered in the lawful course of professional practice
unless the practitioner regularly engages in the dispensing or
administering of controlled substances and charges patients,
either separately or together with charges for other
professional services, for substances so dispensed or
administered.
Question: What reports must be filed if a practitioner
experiences a theft or significant loss of controlled
substances?
Answer: The practitioner shall notify the local DEA
office, in writing, of the theft or significant loss of any
controlled substances within one business day of discovery of
such loss or theft. The practitioner shall also complete and
submit DEA Form 106 which may be found at
www.DEAdiversion.usdoj.gov.
Question: How does a DEA registrant
report breakage or spillage of controlled substances?
Answer: Breakage of controlled substances does not
constitute a "loss" of controlled substances. When
there is breakage, damage, spillage, or some other form of
destruction, any recoverable controlled substances
must be disposed of according to DEA requirements. Damaged goods
may be disposed of through shipment to a "reverse
distributor" or by a DEA approved process. The DEA
recommends that any registrant seeking to dispose of controlled
substances first contact the nearest DEA Diversion Field Office
for disposal instructions. In no case should drugs be forwarded
to the DEA unless the registrant has received prior approval
from the DEA.
If the breakage or spillage is not recoverable,
the registrant must document the circumstances of the breakage
in the inventory records. Two individuals who witnessed the
breakage must sign the inventory records indicating what they
witnessed. The submission of a DEA Form 41, Registrants
Inventory of Drugs Surrendered, is not required for
non-recoverable controlled substances.
The DEA procedures established for the destruction of
controlled substances shall not be construed as altering in any
way the state laws or regulations for the disposal of controlled
substances. When this disposal occurs, it must be reported to
the DEA on a DEA Form 41.
Security
Question: Are there any special security requirements a
practitioner should follow if a stock of controlled substances
is maintained in their office for dispensing and
administering?
Answer: All controlled substances should be stored in a
locked cabinet or other secure storage container with limited
access by the office staff.
Question: Is it appropriate to provide a DEA registration
number when purchasing items other than controlled substances
such as prescription drugs, over-the-counter drugs, or medical
supplies from a distributor?
Answer: DEA strongly opposes the use of a DEA
registration number for any purpose other than the one for which
it was intended, to provide certification of DEA registration in
transactions involving controlled substances. The use of DEA
registration numbers as an identification number is not an
appropriate use and could lead to a weakening of the
registration system. Although DEA has repeatedly made its
position known to industries such as insurance providers and
pharmacy benefit managers, there is currently no legal basis for
DEA to prevent or preclude companies from requiring or
requesting a practitioner’s DEA registration number.
The Centers for Medicare and Medicaid Services has developed
a National Provider Identification (NPI) number unique to each
healthcare provider. The Final Rule for establishment of the NPI
system was published in the Federal Register (FR 3434, Vol. 69,
No. 15) by the Department of Health and Human Services on
January 23, 2004. The effective date of this Final Rule was May
23, 2005; all covered entities were to begin using the NPI in
standard transactions by May 23, 2007. A contingency extension
was provided to covered entities unable to meet the 2007
deadline. Contingency plans were to not extend beyond May 23,
2008.
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