Rule2023-15508
Partial Filling of Prescriptions for Schedule II Controlled Substances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 21, 2023
Effective
August 21, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
On July 22, 2016, the Comprehensive Addiction and Recovery Act of 2016 became law. One provision of the Comprehensive Addiction and Recovery Act of 2016 amended the Controlled Substances Act to allow for the partial filling of prescriptions for schedule II controlled substances under certain conditions. The Drug Enforcement Administration (DEA) is amending its regulations to conform to this statutory provision, as well as to provide direction on gaps not addressed by legislation. DEA will also be amending its regulations to update a cross-reference in a paragraph that will be redesignated with this final rule.
Full Text
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<title>Federal Register, Volume 88 Issue 139 (Friday, July 21, 2023)</title>
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[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Rules and Regulations]
[Pages 46983-47002]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15508]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1306
[Docket No. DEA-469]
RIN 1117-AB45
Partial Filling of Prescriptions for Schedule II Controlled
Substances
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: On July 22, 2016, the Comprehensive Addiction and Recovery Act
of 2016 became law. One provision of the Comprehensive Addiction and
Recovery Act of 2016 amended the Controlled Substances Act to allow for
the partial filling of prescriptions for schedule II controlled
substances under certain conditions. The Drug Enforcement
Administration (DEA) is amending its regulations to conform to this
statutory provision, as well as to provide direction on gaps not
addressed by legislation. DEA will also be amending its regulations to
update a cross-reference in a paragraph that will be redesignated with
this final rule.
DATES: This final rule is effective August 21, 2023.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 776-3882.
SUPPLEMENTARY INFORMATION:
I. Legal Authority
On July 22, 2016, the President signed the Comprehensive Addiction
and Recovery Act (CARA) of 2016 into law as Public Law 114-198. Section
702(a) of the CARA amended 21 U.S.C. 829 of the Controlled Substances
Act (CSA) by adding subsection (f) to allow a pharmacist to partially
fill a prescription for a schedule II controlled substance under
certain conditions.
[[Page 46984]]
Specifically, subsection (f)(1) allows such partial filling where
requested by the prescribing practitioner or the patient provided that
all of the following conditions are satisfied: (1) The partial filling
must not be prohibited by State law; (2) the prescription must be
written and filled in accordance with the CSA, DEA regulations, and
State law; and (3) the total quantity dispensed in all partial fillings
must not exceed the total quantity prescribed. In addition, subsection
(f)(2) provides that the remaining portions of a partially filled
prescription for a schedule II controlled substance, if filled, must be
filled no later than 30 days after the date on which the prescription
is written, unless the prescription is issued as an emergency oral
prescription, in which case the remaining portion, if filled, must be
filled no later than 72 hours after it was issued.
This final rule is revising DEA regulations to incorporate the
foregoing statutory provision. In addition, DEA is further revising its
regulations to address regulatory requirements not addressed by section
702(a) of the CARA. This provision does not address how the prescribing
practitioner should indicate that a prescription for a schedule II
controlled substance must be partially filled. Likewise, it does not
specify how a pharmacist should record the partial filling of such a
prescription. However, it does provide that partial filling of
prescriptions for a schedule II controlled substance is permitted if
the prescription is written and filled in accordance with, among other
things, regulations issued by DEA. 21 U.S.C. 829(f)(1)(B). Accordingly,
Congress gave DEA explicit authorization to fill in any gaps in the
regulatory scheme not addressed by Congress itself in section 702(a) of
the CARA. DEA is exercising this authority by issuing this rule to give
practitioners and pharmacists clear guidance in this area, and to allow
for proper auditing by DEA.
II. Background
There is potential for benefit to patients and society as a result
of this rule. For patients, partial filling could lower the cost of
prescriptions by reducing the quantity of unused schedule II controlled
substances due to not needing to continue on drug therapy. Reducing the
dispensing of schedule II controlled substances that are ultimately not
needed would also help to reduce the risk that the patient might
develop physical dependence or an addiction to opioids or other
schedule II controlled substances. The existence of unused drugs in
U.S. households contributes to growing rates of substance misuse of
prescription drugs among Americans. Keeping and storing unused
medications in households pose several risks related to diversion,
accidental overdose, and consumption of spoiled substances.\1\ Reducing
the quantity of unused schedule II controlled substances would reduce
the risk of diversion.
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\1\ ``Safe Disposal of Unused Controlled Substances: Current
Challenges and Opportunities for Reform,'' Avalere, <a href="http://www.ncdoi.com/osfm/safekids/documents/omd/safedisposalofunusedcontrolledsubstancesreport.pdf">http://www.ncdoi.com/osfm/safekids/documents/omd/safedisposalofunusedcontrolledsubstancesreport.pdf</a>.
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III. Summary of the Notice of Proposed Rulemaking
DEA published a notice of proposed rulemaking (NPRM) in the Federal
Register on December 4, 2020, providing an opportunity for comments to
be submitted. 85 FR 78282. The comment period closed February 2, 2021.
While DEA invited comments on the entire NPRM, DEA specifically pointed
commenters to the then proposed changes to 21 CFR 1306.13(b)(3), (4),
and (5), which were filling in gaps not addressed by section 702(a) of
the CARA. The other proposed amendments to 21 CFR 1306.13(b)(1) and (2)
merely reiterated the statutory requirements of section 702(a) of the
CARA, and therefore, cannot be changed.
IV. Discussion of Regulatory Text Comments
DEA received 37 comments on the NPRM. Commenters included a
nonprofit organization representing hospitals, a trade association
representing chain drug stores, an association representing pharmacy
boards, three professional pharmacist associations, practicing nurses
and nurse practitioner students, and other individual or anonymous
commenters. Most commenters generally supported the rule with some of
those supporters also raising issues of concern or desiring
clarification. Some commenters who opposed the rule primarily expressed
concern about the impact on individuals with chronic pain, mistakenly
assuming that the rule, if finalized, would require a prescription for
a schedule II controlled substance to be partially filled. In fact, the
rule simply proposed amending DEA's regulations to allow an option for
a prescription for a schedule II controlled substance to be partially
filled, if requested by the prescribing practitioner or patient. The
comments are summarized below, along with DEA's responses.
General Opposition to Provisions Mandated by Congress
Issue: Several commenters expressed opposition to provisions of the
rule that were mandated by Congress, stating that the government should
not interfere with the prescribing of medicine.
Response: As discussed in the NPRM, the provisions which are
directly from the CARA cannot be modified. DEA has to allow both the
patient and the practitioner to request partial fills. However, because
DEA was granted the authority to fill in gaps not addressed by the
CARA, DEA is able to create regulations to direct the manner which the
partial fill is to be requested and recorded. Also, the government may
be involved in the prescribing of medicine, as agencies such as Indian
Health Services, Department of Veterans Affairs, Department of Defense,
and Bureau of Prisons can serve as the healthcare provider.
General Requirements for Partial Filling
Issue: Commenters expressed concern over DEA's stance in the
proposed rule's preamble and in the proposed amendment at 21 CFR
1306.13(b)(1)(ii) regarding the validity of a prescription.
Specifically, commenters urged DEA to reconsider its position,
expressed in the proposed rule, of interpreting a prescription to be
invalid if the quantity exceeds the limits of state law. An association
asked for clarification and guidance when the partial fill is the
result of limitations set by state or local law. One association stated
that this is inconsistent with DEA policy that was set forth in a DEA
policy letter dated August 24, 2011, and that DEA will cause confusion
amongst healthcare providers. The association's comment included a
quote from this DEA policy letter, which stated ``DEA expects that when
information is missing from or needs to be changed on a Schedule II
controlled substance prescription, pharmacists use their professional
judgment and knowledge of state and Federal laws and policies to decide
whether it is appropriate to make changes to that prescription.''
Commenters stated that this conflicts with the position taken in the
proposed rule and that it also is inconsistent with many state laws,
which allow a prescription written in excess of state limits to still
be considered valid. Furthermore, commenters stated that multiple State
Boards of Pharmacy have also issued guidance saying that state laws do
not require pharmacists to confirm the validity of higher quantity
prescriptions for schedule II controlled substances with the
prescribing
[[Page 46985]]
pharmacist, due to states having exceptions to their quantity limits.
Finally, multiple commenters asked DEA to clarify the actions that
pharmacists will be allowed to do regarding the partial filling of a
prescription for a schedule II controlled substance and to revise the
proposed regulatory text to ensure pharmacists can continue changing
the partial fill quantities when prescriptions are written in excess of
state limits.
DEA Response: In the NPRM's preamble, DEA acknowledged that many
states have begun enacting partial fill laws and limiting the amounts
allowed to be prescribed for initial prescriptions.\2\ DEA referenced
the CARA which states that a prescription for a schedule II controlled
substance may be partially filled if the act of doing so is not
prohibited by state law, and the prescription is written and filled in
accordance with DEA regulations and state law. 21 U.S.C. 829(f)(1).
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\2\ 85 FR 78282, 78284, December 4, 2020.
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DEA wishes to clarify that where state law provides exceptions or
exemptions for prescriptions for schedule II controlled substances
which exceed the state limit for quantity, the prescription is not
considered in violation of the CARA. DEA notes that in the NPRM, the
stance was taken that a prescription written in excess of state law
would be considered invalid. However, in light of information received
from commenters, DEA has learned that states have begun implementing
laws and issuing guidance to address prescriptions written in excess of
state law quantity limits.
In acknowledgement of those states' actions, DEA will not consider
a prescription for a schedule II controlled substance to be invalid
when written in excess of the state limit, when the state has provided
an exception or exemption. In light of the comments discussed above,
DEA is not adopting the final two sentences of the proposed regulatory
language for 21 CFR 1306.13(b)(1)(ii), which had proposed to provide
that, ``A prescription written for a quantity that exceeds the limits
of State law is not a valid prescription, therefore, the prescription
may not be filled as written. Because such a prescription is not valid,
it also cannot be partially filled.''
Regarding the commenters' request to change the regulatory text to
allow pharmacists the authority to modify prescriptions by fixing the
amount of the partial fill so that it is not in excess of a state's
limit, DEA declines to make such a change. DEA considers the August
2011 policy letter--referenced by several commenters--to be a guidance
document which is no longer in effect. The only guidance documents
currently in effect are those which are located on DEA's website in the
guidance portal.\3\ This policy letter is not in the guidance portal.
DEA's regulations do not provide for a pharmacist to modify a
prescription for a schedule II controlled substance. Where a pharmacist
knows that a modification is needed to address the amount being in
excess of the state's limit (and the state does not have an exception
or exemption in place), the pharmacist should use their knowledge of
state laws and state guidance and return the prescription to the
prescribing practitioner.
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\3\ See Guidance Documents (<a href="http://usdoj.gov">usdoj.gov</a>) at <a href="https://apps.deadiversion.usdoj.gov/guidance/#no-back-button">https://apps.deadiversion.usdoj.gov/guidance/#no-back-button</a>. Last accessed
April 25, 2022. The guidance document portal is a website where
individuals can access all of DEA's current guidance. The guidance
documents are not binding and lack the force and effect of law, and
therefore, not to be used as a substitute for regulation.
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Request of Partial Fill by a Practitioner
Issue: There were twenty-two comments received discussing the
proposed amendment for 21 CFR 1306.13(b)(3). Many of the comments
received regarding the request of partial fills from a practitioner
stated that this proposed addition to DEA's regulations provides clear
guidance to prescribers, and will encourage practitioners to prescribe
schedule II controlled substances sparingly. There were also comments
with a few suggested modifications and requests for clarifications on
the proposed regulatory text for practitioner requested partial fills.
Commenters stated that practitioners rarely request a partial fill
when the prescription is first issued, and they usually do not choose
this option until it is presented by the pharmacist to them. A few
associations and other commenters suggested that DEA explicitly
recognize that the prescriber may authorize a partial fill at a later
date, following a consultation with a pharmacist, constituting an
amendment to the original prescription. In effect, many of the
commenters requested the authorization for pharmacists to dispense a
partial fill for the prescription without requiring the prescribing
practitioner to issue a new prescription.
DEA Response: DEA appreciates all of the comments received in
response to the proposed amendments for the partial fills requested by
practitioners. DEA joins the commenters in hoping that this will help
address the opioid and overdose crisis and encourage practitioners to
consider all options available when prescribing schedule II controlled
substances.
Through this rulemaking, DEA has come to understand that many
practitioners do not request partial fills on prescriptions for
schedule II controlled substances initially. Instead, the request comes
after the pharmacist receives the prescription and then contacts the
prescribing practitioner to discuss that prescription. In response to
the commenters' concerns, DEA wants to clarify in 21 CFR 1306.13(b)(3)
that a partial fill may be authorized by the prescribing practitioner
during subsequent communication between the pharmacist and practitioner
following the date after the prescription was first issued. This
authorization would still be considered a request by the practitioner
and a new prescription will not be required.
Through this final rule, the pharmacist must add the partial fill
request to the prescription for a schedule II controlled substance by
notating on the prescription ``Authorized by Practitioner to Partial
Fill.'' The annotation must also include the name of the practitioner
they spoke with, the date and time of the communication, and the
pharmacist's initials.
DEA's regulations do not provide for pharmacists to modify
prescriptions for schedule II controlled substances. As such, DEA does
not consider the notations made by the pharmacist, as a result of the
subsequent communication with a practitioner after the prescription was
issued, to be an amendment or modification to the prescription. DEA
declines the commenters' request to grant authorization for pharmacists
to amend or modify prescriptions for schedule II controlled substances.
Request of a Partial Fill by a Patient
Issue: DEA received fifteen comments addressing the proposed
provision for 21 CFR 1306.13(b)(4), most in support of partial fill by
patient request. Many of the commenters also provided suggestions or
sought clarification on issues presented in the questions in the
``Economic Impact'' section of the NPRM.\4\ Those issues are addressed
later in ``Discussion of Economic Comments'' section.
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\4\ 85 FR 78282, 78290.
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Some commenters stated that this proposed amendment was too narrow
of an interpretation of Congressional intent in the CARA. A commenter
also said that it conflicts with the Federal Health Insurance
Portability and
[[Page 46986]]
Accountability Act (HIPAA) privacy requirements found at 45 CFR
164.510(b)(3),\5\ which set the standard for limited uses and
disclosures of protected health information (PHI) when the individual
is not present. Specifically, a commenter noted that DEA, in the
proposed rule, interpreted ``patient,'' as used in the CARA, to not
include a member of the patient's household. Commenters stated
caregivers should be authorized to request a partial fill of
prescriptions without the involvement of the patient, as many
caregivers/representatives are dropping off and/or picking up
prescriptions on behalf of the patient. Commenters also gave the
example of a caregiver for a minor child or a caregiver for a dependent
adult who has a medical power of attorney as someone who should be
authorized to make the partial fill request. A commenter further stated
that because patients are not usually initiating the partial fill
request (without the suggestion/involvement of the pharmacist), they
are unlikely to send a written request with the caregiver or call ahead
to the pharmacy to make such a request.
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\5\ This provision states that a ``covered entity may use
professional judgment and its experience with common practice to
make reasonable inferences of the individual's best interest in
allowing a person to act on behalf of the individual to pick up
filled prescriptions . . . or other similar forms of [PHI].'' A
covered entity under HIPAA is a health care provider, health plan,
or health care clearinghouse involved in the transmission of PHI.
See 5 U.S.C. 164.103 and 164.104(a).
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Commenters also suggested that doctors should educate patients on
the option to request partial fill of prescriptions, otherwise a
patient may not make the request on their own. It was suggested this
should include potential risk, and proper disposal, and address
patients' fears associated with both schedule II controlled substances
and the partial fill process. This would promote patient-centered care
and empower patients with the opportunity to contribute to their own
treatment plan.
A commenter suggested that the partial fill request by the patient
only be allowed with an accompanying recommendation by the pharmacist
because the pharmacist would be more knowledgeable than the patient
about patient tolerance and compliance history. Others maintained that
the pharmacist should not have to concur with the patient on whether a
partial fill is best for the patient, and that a pharmacist should be
granted the authority to dispense the partial fill to the patient
without the patient's requesting or consenting to the partial fill. One
commenter provided an example to show that a pharmacist is more
knowledgeable than the patient about how long a patient may need to
take a prescription to address short-term pain management.
DEA Response: The comments pertaining to the questions in the
economic impact section of the NPRM are addressed later in the
``Discussion of Economic Comments'' section.
With regard to allowing a partial fill at the request of a
caregiver, DEA recognizes there is the possibility that there are
situations where a caregiver is aware of the benefit for a partial fill
request while the ultimate user (the patient) is unable to provide the
request, however the possibility for abuse of this authority is greater
than the possible benefit. Typically, the patient's right to request,
or not request, a partial fill of their prescription is their right to
exercise; the caregiver's authority is borne of the patient's requests,
and the division of authority should be maintained accordingly. Usually
in those situations where a patient is unable to make the request
themselves, a caregiver would also participate in the patient's
interaction with the prescribing practitioner. Their concerns would be
addressed with the prescribing practitioner and the prescribing
practitioner would be able to issue a prescription with a partial fill
request.
While DEA understands the concerns regarding the HIPAA regulations,
it should also be noted that the CARA only authorizes the ``patient''--
not a member of the patient's household or the patient's caregiver--to
make such request. DEA's interpretation of section 829(f) of the CSA is
not too narrow, as that section only refers to ``the patient or the
practitioner that wrote the prescription'' making the request for the
partial fill. However, DEA acknowledges that in the case of a minor
(under age 18), a parent or legal guardian is often the responsible
party for the care of the child and therefore, is updating the
regulatory text to allow the parent or legal guardian to make a partial
fill request on behalf of the child. In addition, DEA also understands
that there are instances where an adult patient may have a caregiver
who is named as their agent in the adult patient's medical power of
attorney; therefore, DEA is updating the final regulatory text to allow
a caregiver who is the agent named in the adult patient's medical power
of attorney to request a partial fill on behalf of that adult patient.
It is always good practice for a patient and their doctor to engage
in open dialog about the potential risks, proper disposal, and
addressing the patient's fears associated with both schedule II
controlled substances and the partial fill process. It is not, however,
within the purpose of this rule, or the mission of DEA to involve
itself in the practice of medicine or to enforce the elements of good
patient education beyond providing rules, policy, and enforcement.
Last, if a patient is requesting a partial fill then they are
already taking good steps to mitigate any potential harm or damage that
could come as a result of receiving the full prescription. A pharmacist
would more than likely want to encourage the partial fill alternative
rather than suggest against making the request. If a patient's
tolerance and compliance history is at issue, then a partial fill
request would be best in mitigating any potential addiction behavior
and diversion risks. In the event that a pharmacist does not want to
have the consent of the patient for a partial fill, the pharmacist
still has the option of suggesting a partial fill to the prescribing
practitioner. Together, a pharmacist and the prescribing practitioner
would be well-equipped with the knowledge to determine the dosage
quantity necessary to manage a patient's short-term pain.
Recording of Practitioner's Partial Fill Request by a Pharmacy
Issue: There were six comments related to the proposed amendment in
21 CFR 1306.13(b)(5)(i), some of which discussed the recording
requirement in relation to the economic impact. The commenters
requested clarification of the pharmacist's recordkeeping requirements
for fulfilling partial fill requests by prescribing practitioners and
patients, specifically regarding electronic recording of dispensing for
written records when requested by a practitioner. Commenters stated
that the recordation by the pharmacy is warranted and expressed
appreciation towards DEA for not requiring a pharmacist to notate a
partial fill request by a patient when the prescribing practitioner had
already included the request on the prescription, unless the patient is
asking for an even smaller amount. However, another commenter believes
that the recordkeeping requirements are redundant and the regulatory
text should be revised to just require pharmacists to make an
annotation in the electronic dispensing record.
DEA Response: As proposed in the NPRM, and being finalized in this
rule, 21 CFR 1306.13(b)(5)(i) will require the pharmacist to notate the
quantity dispensed on the face of the written
[[Page 46987]]
prescription, in the written record of the emergency oral prescription,
or in the record of the electronic prescription. When it is an
electronic prescription, the quantity dispensed, date dispensed, and
the dispenser must be linked to the record of the electronic
prescription. However, due to commenters' concerns as well as common
practices of DEA's Diversion Investigators, DEA is updating the
regulatory text to allow the option for pharmacists to fulfill
recordkeeping requirements for paper or emergency oral prescriptions
using the pharmacy's electronic recordkeeping system.
The comments which also discussed the economic impact of recording
the practitioner's partial fill request are addressed below in the
``Discussion of Economic Comments'' section.
Recording of Patient's Partial Fill Request by a Pharmacy
Issue: DEA received fifteen comments related to the proposed
amendment in 21 CFR 1306.13(b)(5)(ii). Comments included appreciation
for the clear communication of the requirements established by this
rule, while others suggested modifications.
Of the commenters requesting modifications, several commenters
suggested that DEA revise the proposed language to allow pharmacists to
satisfy the recordkeeping requirement by making an annotation in the
electronic dispensing record, regardless of the format of the original
prescription. Commenters stated that DEA is creating a redundant
requirement by requiring a notation of the quantity dispensed on the
face of the written prescription, in the written record of the
emergency oral prescription, or in the record of the electronic
prescription.
Lastly, commenters suggested that DEA eliminate the proposed
dispensing recordkeeping requirement when a prescriber has already
instructed a partial fill and the patient requests less than the
instructions, as the total quantity dispensed compared to the total
quantity prescribed will be obvious based on the dispensing record.
DEA Response: DEA recognizes that commenters found the NPRM to be
clear in setting forth these recordkeeping requirements, as it was the
intention to be clear in presenting and discussing the requirements
that will be implemented with this final rule.
As stated in the previous response to issues identified for the
practitioner's partial fill request, DEA is changing the regulatory
text to allow pharmacists to satisfy the recordkeeping requirement by
using the pharmacy's electronic system regularly used for
recordkeeping. DEA notes that Diversion Investigators regularly look at
the pharmacy's electronic system for paper prescriptions also.
Regarding the notation of prescriptions based on the prescribing
practitioners' method, written prescriptions, emergency oral
prescriptions, or electronic prescriptions, this rule acknowledges that
different types of prescriptions exist. Accordingly, the various types
of prescriptions may require varying methods for annotation of the
partial fill option to prevent over dispensing of controlled
substances. This results in the illusion of redundancy because of the
numerous means by which the partial fill can be requested.
Regarding the comment on the required documentation when a patient
requests a lesser partial fill amount than that specified by the
prescribing practitioner, DEA maintains that it is necessary for the
dispensing pharmacist to annotate the patient's request. Because of the
justifications already established in 21 CFR 1306.13 for partial fill
dispensing of a prescription for a schedule II controlled substance
(e.g., 1306.13(a) partial filling due to inability of the pharmacy to
supply the full quantity), and the legal mandate by the CARA for the
patient's right to request a partial fill, it is necessary that
annotation be made for any partial fill requests that may be different
from the partial fill amount requested by the prescribing practitioner.
The documentation of these modifications from the prescribing
practitioner's original instruction of partial fill, at the request of
the patient, helps to prevent any suspicion of diversion due to
deviation from the original prescription. DEA does not interpret the
CARA to allow any ``assumption'' for a justification of a more limited
dispensing than originally requested.
Effective Date of Final Rule
Issue: An association requested that the effective date of the rule
be set at six months after the publication of the final rule. The
association stated that pharmacies will need adequate time to update
their systems, policies, and procedures to be in compliance with the
new requirements.
DEA Response: DEA acknowledges the association's concern regarding
being in compliance with DEA's regulations. However, DEA notes that
many, if not all, electronic pharmacy systems already have the ability
to show partial fills. Also, many systems may have a free text field
that would allow a pharmacist to use for additional notes. In addition,
since many states have already implemented partial filling regulations,
DEA further believes that many pharmacies already have the needed
systems to effectuate the allowance of partial fills. DEA notes that
many of the policies and procedures that this association may view as a
need to be updated are not so involved that pharmacies would need more
than 30 days. As such, DEA is making this rule effective 30 days after
the publication of the final rule.
Other Issues
Issue: DEA received a comment from an association which requested
clarification and written guidance in addressing cases when a
pharmacist is unable to supply the full quantity in a prescription for
a schedule II controlled substance, as well as three additional
situations. One of the additional situations, ``Situation 2,'' pertains
to when the prescription quantity exceeds the quantity limits set by
state or local law. This situation has already been addressed above in
the ``General Requirements'' Section. ``Situation 1'' asks for guidance
to be provided when dealing with a partial fill resulting from a health
plan insurer's benefit rules. For ``Situation 3,'' the association
wants guidance on how to proceed when the pharmacy has a policy which
limits the quantity that can be dispensed at a time.
DEA Response: DEA has already implemented regulations addressing a
partial fill as a result of a pharmacy being unable to supply the full
quantity in a prescription for a schedule II controlled substance.
Pursuant to 21 CFR 1306.13(a), the partial fill is permissible and the
pharmacist has to make a notation of the quantity supplied on the face
of the written prescription, the written record of the emergency oral
prescription, or in the electronic prescription record. In addition,
the remaining portion may be filled within 72 hours of the first
partial filling. If the pharmacy cannot fill the remainder in that
time, they are to notify the prescribing practitioner.
Situations (1) and (3) are not subject to section 702 of the CARA,
as these would not be requests by the patient nor practitioner for a
partial filling. For either of these situations to be covered by this
rulemaking, they would need to be considered a request by the patient
or the practitioner. In these situations, the pharmacist should discuss
options for filling the prescription with the prescribing practitioner.
Furthermore, in Situation (1), a patient's decision to receive the full
prescribed amount despite health plan coverage limitation would also
fall outside of section 702 of the CARA, as it would not be a partial
fill request.
[[Page 46988]]
Out of Scope Comments
DEA appreciates all comments that were received during the comment
period. DEA received some general comments which were outside of the
scope of this rule. They did not touch on the actual changes to the
proposed regulatory text, nor did they answer any of the economic
questions that were put forth.
V. Discussion of Economic Analysis Comments
The NPRM contained a Regulatory Analysis section which assessed the
economic implications of this rulemaking. DEA examined the costs and
costs savings associated with this rulemaking, as well as considered
three regulatory approaches regarding the need to require notification
when a partial fill is requested by the patient. DEA stated that this
was an evaluation of activities that were not previously permitted
before the CARA amended the CSA to add 21 U.S.C. 829(f), and therefore,
it was difficult to estimate the level of participation for partial
filling of a prescription for a schedule II controlled substance. As
such, DEA also asked eight questions of the public related to the
economic impact of the NPRM.
Costs and Costs Savings
Issue: Many of the commenters questioned whether the patient will
be charged two co-pays, stating that the filling of the remainder of
the prescription should not create an additional financial burden for
the patient. They further stated that this rule should have a positive
economic impact because it should result in a lower co-pay, and if the
remainder of the prescription needs to be filled, the additional co-pay
should add up to be the same amount as a full co-pay. An association
requested for DEA to state how a partial fill should be adjudicated by
pharmacies to calculate out-of-pocket costs, so that access issues for
patients are not created. Multiple commenters stated that this rule
would have a positive impact because the unused prescriptions should
decrease demand for opioids, making the drug prices lower. They also
noted that implementing partial fills can reduce waste, cost, misuse,
and abuse potential.
Commenters stated that the rule would increase the time, cost, and
overall waste for practitioners by increasing the time spent writing
and transmitting prescriptions. Commenters referenced an increased need
to educate patients and practitioners, and that DEA should calculate
this into the overall increased-cost (Economic Impact) of this rule.
One association in particular mentioned that while there is the
potential to reduce the amount of unused drugs, they questioned whether
there will be a significant cost savings. The association explained
that most patients pay a co-pay which does not necessarily decrease
based upon small changes in drug quantity. They also expressed the
concern that if co-pays are not reduced for partial fills, then a
patient may pay multiple co-pays, resulting in more money out of
pocket.
Associations showed much support for Alternative 3, which was
chosen by DEA, commenting that they support allowing pharmacists to
dispense partial fills requested by the patients, without requiring
notification to, or consent from, the prescribing practitioner.
Commenters believe that this alternative places the least amount of
burden on pharmacists, practitioners, and patients because it does not
pose a threat to patient safety and allows a pharmacist to dispense the
remainder of the full prescription. However, one association expressed
concern that DEA's estimated time that it takes a pharmacist to record
a partial fill (10 seconds) is too low, and recommended that DEA
conduct a more in depth study to accurately determine the recording
time. In addition, this association stated that it would be a larger
time, cost, and administrative burden placed upon pharmacists in
filling the remainder of the prescription, and advocated for
pharmacists to be adequately reimbursed.
Commenters suggested that Alternative 3 will facilitate rule
utilization by allowing a pharmacist to dispense per a patient's
request independently of the prescriber. They opined that governmental
regulation is not the most appropriate way to limit misuse and
diversion. The commenters stated that partial fills requested by a
patient should not require consent from a practitioner. They further
commented that not requiring consent from a practitioner would reduce
cost and burden to the practitioner, pharmacist, and patient.
Commenters expressed that allowing a pharmacist to dispense the partial
fill as requested by the patient without consent of the prescriber is
the most cost-effective approach. One of these commenters stated that a
provider would not refuse a partial fill request by the patient during
this opioid epidemic.
DEA Response: DEA understands the concerns of co-pay affordability
expressed by commenters and agrees that partial fills should not create
an additional financial burden on patients. DEA joins the commenters in
hoping the implementation of this rule will create a positive economic
incentive for all parties to request partial fills. DEA did not receive
comments from industry regarding co-pays for partial fills. The intent
of this rule is to implement section 702(a) of the CARA that amended
the CSA to allow for the partial filling of prescriptions for schedule
II controlled substances under certain conditions. DEA does not have
the authority to mandate how a pharmacy or an insurance company may
charge for partial fills.
To estimate the prescriber's cost of specifying partial fill
instructions on the prescription, DEA considered the entire duration of
the interaction between the prescriber and the patient, as well as the
prescription writing and transmittal process. While any additional time
to specify the quantity to be dispensed in the partial filling is
minimal, especially, when viewed in relation to the entire duration of
the medical interaction between the prescriber and the patient, DEA
estimates each partial fill requested by the prescriber will require 10
additional seconds for the prescriber to specify the quantity to be
dispensed. DEA believes 10 seconds is a reasonable estimate and the
corresponding cost is included in the economic analysis.
While DEA agrees that educating prescribers and patients regarding
the option to partial fill may increase the likelihood of instructing
or requesting a partial fill, DEA does not plan to require prescribers
or pharmacies to inform patients due to the potential burdens. DEA
informs prescribers and pharmacies of such issues through various
routine conferences and outreach such as: Practitioner Diversion
Awareness Conferences and Pharmacy Diversion Awareness Conferences.
Regarding the association's concern that the estimated burden to
pharmacies is too low, DEA selected Alternative 3 to minimize burden to
prescribers, patients, and pharmacies. While DEA always appreciates
comments, the issue of the estimated burden being too low was not
raised in any other comments, indicating it was not considered an issue
of note. Additionally the absence of any suggested alternative for the
process study or improved estimation leaves little room to directly
address the comment. For these reasons DEA declines to revise the
estimate. DEA believes the burden estimates contained in this rule are
reasonable estimates.
DEA appreciates the support for Alternative 3. DEA estimates this
alternative minimizes the burden placed on patients, prescribers, and
pharmacists.
[[Page 46989]]
Questions From the Regulatory Analysis Section on Benefits and Costs
Below are the eight questions asked in the NPRM to help determine
the economic impact of this final rule. DEA has summarized the
applicable comments received and addressed them, as applicable.
1. Why do so many prescriptions for schedule II controlled
substances result in unused dosages?
Comments: No comments were received in response to this question.
2. Would prescribers start using this proposed regulatory provision
and start giving instructions for partial filling of schedule II
controlled substances, or are there other factors that are likely not
to result in prescribers giving partial filling instructions?
Comments: Commenters pointed to the willingness of a practitioner
to start giving instructions for partial filling, but stated their
belief that many patients may be reluctant to change. A commenter
stated that many of the patients are used to seeing their longstanding
family providers who frequently prescribed the schedule II controlled
substances without assessing other treatment options first. The
commenters expressed that when practitioners attempt to discontinue
prescribing these substances and have the patient use other treatment
options, patients do not tolerate the change well, forcing
practitioners to renew the prescriptions as they are, without partial
fill instructions.
Commenters also provided feedback with discussions of how a
practitioner giving partial filling instructions would increase the
amount of time a provider spends writing and sending prescriptions, and
increase the amount of education needed for a patient to understand the
available options for filling a prescription. The commenters explained
that a practitioner giving partial fill instructions will increase the
visit time with each patient, and stated that DEA needs to calculate
and include this extra time in the economic impact discussion of the
final rule.
DEA Response: While DEA appreciates the opinions stated in the
comments, DEA believes that they were speculative in nature. As there
was no additional data provided that would warrant revision of DEA's
estimated number of partial fills at the direction of the prescriber,
no change to the estimate will be made.
Regarding the time that partial fill instructions would require,
DEA took the physical requirements of writing the additional
information into consideration in developing the Economic Impact
Analysis. The additional time to specify the quantity to be dispensed
in the partial filling is minimal, especially when viewed in relation
to the entire duration of the medical interaction between the
prescriber and the patient. DEA estimates, for both the NPRM and this
Final Rule, that each partial fill requested by the prescriber will
require 10 additional seconds for the prescriber to specify the
quantity to be dispensed. The resulting cost to prescribers is included
in the regulatory analysis section below.
3. How often would a prescriber instruct partial filling of a
prescription for a schedule II controlled substance?
Comments: Some commenters asserted that it is extremely rare for a
prescriber to instruct that a prescription be partially filled. They
added that it is only after a consultation with a pharmacist that the
option is made available to the patient which indicates that
prescribing practitioners are not utilizing and are not educating their
patients on the option for partial fill.
DEA Response: As stated in an earlier response to comments, this
final rule makes changes to proposed 21 CFR 1306.13(b)(3) so that a
prescriber instructing a partial fill after a consultation with a
pharmacist is considered as a partial fill at the request of the
prescriber. DEA did not receive information that would allow DEA to
refine the percent of the partial fill opportunity that will be
realized as a result of this rule.
4. Is it reasonable to anticipate a prescriber will exercise
professional judgment and foresight in determining when partial fill
would be most appropriate, resulting in a minimal number of patients
returning for the remainder of the partially filled prescription or
experiencing pain because they run out of medication? Would prescribers
be likely to use consistent criteria for determining when to give
partial refills? Given that the majority of schedule II prescriptions
are not fully utilized, should prescribers request partial fills in
most cases?
Comments: Commenters stated that practitioners receive extensive
training and are skilled in relaying facts and concerns to their
patients. They further stated that most practitioners have the
patient's best interests and health at heart and they will do what they
can to facilitate best practices and patient safety.
Many commenters expressed concern regarding biases held by
practitioners. Specifically, these commenters voiced concern that
without criteria to go along with this rule, practitioners will use
their implicit biases to dictate when they choose to prescribe partial
fills for a patient. Commenters stated that these biases are a result
of racial and ethnic disparities in healthcare. One commenter gave an
example that Black patients are less likely to be prescribed pain
medications and they receive lower dosage amounts. A commenter also
explained that there are some tribes with high rates of opioid
addiction and therefore, some practitioners may prescribe less quantity
or choose a partial fill for them based off assumptions rather than
real risks for addiction.
DEA Response: While DEA did not get answers to the last part of
this question, it is apparent that many commenters are concerned that
instructions for partial fills will not be given equally across the
board. DEA appreciates the commenters' concern and understands that
this is a significant cause for concern. However, DEA does not regulate
the practice of medicine and it is expected that practitioners would do
so without bias. DEA's regulations are an extension of the CARA, and
only serve to implement that legislation which was passed by Congress.
While this issue may be of significant concern, it is therefore outside
the authority granted to DEA by the CSA. DEA did not receive
information that would allow DEA to refine the economic analysis.
5. How likely are patients to request partial filling at the
pharmacy when the prescriber has not given instructions for a partial
fill on the prescription?
Comments: The comments received by DEA stated that a patient would
probably ask for the full prescription on the day that their pain is
high, as they probably think the pain will remain at that level
throughout their recovery. A commenter opined that when patients are
suffering from an acute problem, it is unlikely that they would opt for
partial fills because that would require two trips to the pharmacy in
72 hours versus one trip. Other commenters stated that patients are
less likely to request a partial fill on their own when they do not
know much about the prescribed drug and expected outcomes. They also
said that patients need to have discussed with their practitioners the
potential risks, proper disposal, and any of the patient's fears.
In addition, commenters expressed concern that socioeconomic
factors could negatively impact the filling of the remainder of the
prescriptions, as patients may not be able to afford the remainder of
the prescription. These commenters stated that patients may not be able
to afford the medicine, with possible additional co-pay fees, or may
[[Page 46990]]
lack the means for transportation to and from the pharmacy. Commenters
further stated that patients may alternatively request the partial fill
because they know that they will not need the entire amount prescribed
and they want to limit the exposure for themselves or their households
to the controlled substances.
DEA Response: DEA acknowledges that a current state of intense pain
could influence one's ability to recognize that the level of pain will
diminish over time. DEA encourages patients that are informed by their
provider about the option of partial filling to discuss their options
with the pharmacist and, with the pharmacist's help, make the best
choice for their situations. DEA did not receive information that would
allow DEA to refine the economic analysis.
6. Is it reasonable to assume that a patient interested in a
partial filling of a schedule II controlled substance would request the
prescriber to provide instructions on the prescription?
Comments: DEA did not receive any comments specifically offering
feedback on this question. However, DEA received comments offering
insight for the other questions which helped DEA gain insight about the
answer to this question. The commenters offered insight that a patient
may face transportation issues or may be in so much pain at the time
that the prescription would be written that they would not want a
partial fill.
DEA Response: While DEA did not receive any feedback directed
towards this question, DEA notes that responses to other questions
helped DEA gain insight to this situation. DEA understands that some
patients may experience hardships with getting to and from the
pharmacy. DEA also acknowledges that there are times when a patient's
pain may be so intense that they cannot recognize the likelihood that
the pain will diminish with time. The comments received did not include
information that would allow DEA to refine the economic impact
analysis.
7. Is it reasonable to assume that when prescribers do not request
a partial fill patients will generally not request a partial fill?
Comments: While DEA did not receive comments that specifically
addressed this question, it is reasonable to infer from the comments in
general that patients may not request a partial fill when their
practitioner did not prescribe it. As previously observed, commenters
mentioned that many patients may choose to receive the entire quantity
that was prescribed for various reasons. The commenters explained that
a patient may know that they will have a hard time returning to the
pharmacy due to lack of transportation. Commenters also stated a
patient may feel that they are in so much pain that they would need the
entire amount. In addition, commenters mentioned that patients may not
know that they can request a partial fill.
DEA Response: DEA appreciates the comments received that allowed
for inference on answers to this question. While DEA wished to collect
additional information to aid in the understanding of and possible
refinements to the economic impact of this rule, no responses provided
any such information that facilitated refining the existing economic
analysis.
8. Questions for industry including private and public plans and
entitlements:
a. What are likely requirements for co-pay in a partial filling?
b. Would the co-pay be reduced?
c. Would there be a co-pay when a patient returns for filling the
remainder of a partially filled prescription (full amount or reduced
amount)?
d. Would a patient likely spend less on a partial fill than on a
full prescription?
e. If so, would requesting two or more partial fills likely cost
the patient more than filling the full prescription initially?
Comments: No comments specifically answered these questions. Many
commenters hoped that this provision would not result in a multiple co-
pay charge. One association in particular voiced concern regarding
partial fills resulting in double co-pays for patients. Commenters
hoped that this would mean a lower co-pay for a partial fill, otherwise
there would not be any savings.
DEA Response: DEA acknowledges and understands the commenters'
concerns. With this rulemaking, DEA is not setting guidelines for
insurance companies. DEA does not have the authority to mandate how
insurance companies should charge their customers. DEA had hoped to
receive feedback from insurance companies so that DEA could offer more
guidance to the public, however no insurance companies provided
comments on this question. DEA notes that its regulations already allow
partial fills for prescriptions for schedules III-V controlled
substances \6\ and in instances of limited supply, for schedule II
controlled substances.\7\ DEA anticipates that insurance companies
would follow the same methods for assessing co-pays for prescriptions
for schedule II controlled substances as it currently does for
prescriptions for schedule III-V controlled substances. However, DEA
cannot be sure of that theory; therefore, DEA defers to insurance
companies on how they will handle co-pays for partial fills. DEA did
not receive information that would necessitate refining the economic
analysis.
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\6\ DEA regulations for partial filling of prescriptions for a
controlled substance listed in schedules III, IV, and V are
contained in 21 CFR 1306.23.
\7\ Partial fills of prescriptions for a controlled substance
listed in schedules III-V are allowed through 21 CFR 1306.13. 21 CFR
1306.13(a) states when a partial fill of a prescription for a
schedule II controlled substance is allowed due to limited supply at
the pharmacy.
---------------------------------------------------------------------------
VI. Provisions Being Implemented in the Final Rule
DEA is implementing and finalizing the proposed regulatory text
with modifications, discussed below, to clarify concerns brought forth
by commenters. As proposed, to implement the partial filling provisions
of CARA for prescriptions for schedule II controlled substances, DEA is
re-designating existing paragraphs (b) and (c) of 21 CFR 1306.13 as
paragraphs (c) and (d), respectively. This final rule places the
provisions for partial filling in new paragraph (b). Here, registrants
will find the requirements for patients and practitioners to request
partial fills under certain circumstances and the involved notation by
the prescriber to specify the partial fill request, as well as the
involved recording by the pharmacy of the partial filling itself.
General Requirements--21 CFR 1306.13(b)(1)
All of the ``General requirements'' provisions are being
implemented as proposed, with the exception of 21 CFR
1301.13(b)(1)(ii). Generally, the prescribing practitioner or a patient
must request a partial fill for a prescription for a schedule II
controlled substance. Such a prescription may be partially filled if it
is not prohibited by State law and it is written in accordance with the
CSA, DEA regulations, and State law. Also, the total quantity dispensed
in all of the partial fillings cannot exceed the total quantity
prescribed by the practitioner.
In the NPRM, the preamble and the regulatory text in 21 CFR
1301.13(b)(1)(ii) stated that a prescription was invalid if it set
forth a dispensing quantity of a controlled substance that exceeded the
state limits, and therefore would be ineligible for a partial filling.
In light of the public comments, as well as various
[[Page 46991]]
implemented state legislation and guidance providing exemptions or
exceptions for prescriptions written in excess of the state limits, DEA
will not implement that portion of the proposed amendment, and is
deleting the final two sentences of the proposed regulatory text as a
result.
Time Limitations--21 CFR 1301.13(b)(2)
DEA is adding 21 CFR 1301.13(b)(2) as proposed. After the first
partial fill of the prescription for a schedule II controlled substance
is filled, if a patient chooses to fill the remainder, the remaining
portions must be filled no later than 30 days after the date of the
prescription. However, when it is an emergency oral prescription, the
remainder, if filled, must be filled no later than 72 hours after the
date of the prescription.
Partial Fill Request by the Practitioner--21 CFR 1306.13(b)(3)
DEA is adding 21 CFR 1306.13(b)(3) which will require the
practitioner to specify the quantity to be dispensed in the partial
filling on the face of the written prescription, in the written record
of the emergency oral prescription, or in the record of the electronic
prescription. This information must be included on the prescription,
along with other information required for issuing a prescription under
21 CFR 1306.05, at the time it is signed by the practitioner. In the
case of an emergency oral prescription, this information must be given
when the prescription is being communicated by the prescribing
practitioner to the pharmacist. This approach ensures that the
practitioner's intent regarding partial filling is made clear to the
pharmacist, and is properly memorialized in the dispensing records.
The term ``record of the electronic prescription'' is being used in
place of the term ``electronic prescription record,'' which was
utilized in the NPRM. The previous term, ``electronic prescription
record,'' was ambiguous and could imply a hard-copy/written
prescription being tracked electronically by a pharmacist after
receipt. The new term, ``record of the electronic prescription,''
clarifies a prescription that is generated and transmitted
electronically, and is having a record attached by the prescription-
tracking software utilized by the pharmacist.
This final rule amends the proposed provision to authorize a
practitioner to stipulate a partial fill or refill at a later date than
when issuing the original prescription, after an oral consultation
between the practitioner and the pharmacist, and specifies that the
pharmacist must annotate the discussion on the prescription as
stipulated in 21 CFR 1306.13(b)(5)(i).
Partial Fill Request by the Patient--21 CFR 1306.13(b)(4)
This provision is being finalized to allow a patient to request the
partial filling of a prescription for a schedule II controlled
substance at the pharmacy, even if the prescribing practitioner did not
specify a request for a partial filling, as provided in 21 CFR
1306.13(b)(3). Section 702(a) of the CARA does not place any
limitations on how the patient may make a partial fill request. In
addition, DEA recognizes that many post-surgery patients may have a
difficult time visiting the pharmacy in person. Therefore, this rule
does not require an in-person request by the patient, but instead
allows alternative pathways for the patient to make such a request and
specify the amount to be filled (e.g., phone call by the patient to the
pharmacist, or a signed written note from the patient and delivered by
a family member to the pharmacist). As proposed and discussed earlier,
the partial fill can only be requested by the patient, not a member of
the patient's household or a caregiver. However, this final rule is
revising the proposed provision to also allow others to request a
partial filling where the patient is a minor child (under age 18) or an
adult who has named their caregiver as their agent in the adult
patient's medical power of attorney. In those situations, DEA
authorizes the parent or legal guardian for the minor child and the
caregiver named as the agent in the medical power of attorney for the
adult patient to request the prescription for the schedule II
controlled substance to be partially filled in the same manner that a
patient may request the partial fill: in person, in writing if signed
by the parent or legal guardian (for the minor child) or the caregiver
named in the medical power of attorney (for the adult patient), or by a
phone call from the parent or legal guardian (for the minor child) or
the caregiver named in the medical power of attorney (for the adult
patient) to the pharmacist. Finally, where a practitioner has requested
the partial filling of a prescription, neither the patient, a parent or
legal guardian (in the case of a minor), nor the caregiver named in the
medical power of attorney (for the adult patient) may request a partial
filling in an amount greater than that specified by the practitioner.
Pharmacy's Recording of the Partial Fill of a Schedule II Controlled
Substance
When Requested by the Prescribing Practitioner--21 CFR 1306.13(b)(5)(i)
This provision specifies how a pharmacist must record a partial
fill of a prescription for a schedule II controlled substance when a
practitioner makes such a request pursuant to 21 CFR 1306.13(b)(3), as
discussed above. When presented with a prescription properly specifying
a partial filling request, the pharmacist must record the partial
filling in a manner similar to that required under the existing
regulations for other circumstances.\8\ Specifically, upon each such
partial filling request, the dispensing pharmacist must make a notation
of the quantity dispensed on the face of the written prescription or in
the pharmacy's electronic recordkeeping system, in the written record
or in the pharmacy's electronic recordkeeping system of the emergency
oral prescription, or in the record of the electronic prescription. For
electronic prescriptions, there must be an electronic prescription
record, and the record must be permanently attached to the electronic
prescription. Also, for each such partial filling, the pharmacy must
maintain a record with the date of each dispensing, the name or
initials of the individual who dispensed the substance, and all other
information required by 21 CFR 1306.22(c) for schedule III and IV
prescription refills. For electronic prescriptions specifically,
pharmacy applications must allow required information pertaining to the
quantity, date, and the dispenser to be linked to each electronic
controlled substance prescription record (as also required by 21 CFR
1311.205(b)(10)).
---------------------------------------------------------------------------
\8\ Longstanding DEA regulations, which are not be changed by
this rule, also allow the partial filling of a schedule II
prescription where the pharmacist is unable to supply the full
quantity called for in the prescription (21 CFR 1306.13(a)), the
patient in a long-term care facility (21 CFR 1306.13(b), or the
patient has a terminal illness (21 CFR 1306.13(c)).
---------------------------------------------------------------------------
These above provisions were as proposed with slight changes for
clarification. As previously stated, the term ``record of the
electronic prescription'' has been used in place of the term
``electronic prescription record'' here also to ensure the
understanding that DEA is referring to a prescription that is generated
and transmitted electronically. Also, as said above DEA is also
allowing the notation of the quantity dispensed to be notated in the
pharmacy's electronic records due to the regular business practices of
pharmacies, as well as common
[[Page 46992]]
practices of DEA's Diversion Investigators.
This final rule is revising the proposed regulatory text to allow
for where the prescribing practitioner conveys his or her request for a
partial filling after issuing the prescription, and is based upon an
oral consultation with the pharmacist. In those situations, the
dispensing pharmacist must notate such discussion with the following:
``Authorized by Practitioner to Partial Fill,'' the name of the
practitioner, the date and time of the discussion, and the pharmacist's
initials.
When Requested by the Patient--21 CFR 1306.13(b)(5)(ii)
With the addition of 21 CFR 1306.13(b)(5)(ii), when partially
filling a prescription for a schedule II controlled substance at the
request of the patient, the caregiver of an adult patient who is named
in their medical power of attorney, or a parent or legal guardian of a
minor patient (under age 18), the pharmacist must make the same
notation on the prescription as when partially filling a prescription
as requested by the prescribing practitioner on the initial
prescription. Also, just as with the pharmacy's recording requirements
when the prescribing practitioner is the requester, if the prescription
is electronic, then the notation must be linked to the record of the
electronic prescription. Since the prescription will not contain the
partial fill instructions from the prescriber, this rule also requires
the pharmacist to indicate on the prescription who specifically
requested the partial fill (i.e., whether it is the patient, parent or
legal guardian of a minor patient, or caregiver of an adult patient
named in the adult patient's medical power of attorney). On all of such
partial fill requests and filling, the pharmacist must record: (1)
``The [patient, parent or legal guardian of a minor patient, or
caregiver of an adult patient named in a medical power of attorney,
whichever is applicable] requested partial fill on [date such request
was made],'' and (2) the quantity dispensed. As referenced in the
section Partial Fill Request by Patient, where a practitioner has
requested the partial filling of a prescription, the patient, parent or
legal guardian, or caregiver of an adult patient may not request a
partial filling in an amount greater than that specified by the
practitioner.
Here also, the regulatory text is being finalized with slight
changes. As mentioned above, DEA is finalizing the regulatory text
using the term ``record of the electronic prescription'' in place of
the term ``electronic prescription record.'' Also with finalizing this
provision, DEA is allowing the pharmacist to notate the quantity
dispensed in the pharmacy's electronic records.
Additional Regulatory Text Change--Re-Designated 21 CFR 1306.13(d)(1)
As previously stated, DEA is finalizing this rule with changes for
clarification in regards to the options which the pharmacy can notate
the partial fill for recordkeeping requirements. This final rule adds
the partial fill requirements of section 702(a) of the CARA into 21 CFR
1306.13(b) and redesignates existing paragraphs (b) and (c) as
paragraphs (c) and (d), respectively. In the redesignated 21 CFR
1306.13(d) in this final rule, there is a reference in existing
paragraph (c)(1) to 21 CFR 1306.13(b), which DEA is updating with this
rule. DEA is changing that reference in redesignated paragraph (d)(1)
to 21 CFR 1306.13(c).
Regulatory Analysis
Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review)
This rule was developed in accordance with the principles of
Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies to
assess all costs and benefits of available regulatory alternatives and,
when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, public health and
safety, and environmental advantages; distributive impacts; and
equity). E.O. 13563 is supplemental to and reaffirms the principles,
structures, and definitions governing regulatory review as established
in E.O. 12866. The E.O. classifies a ``significant regulatory action''
as any regulatory action that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more, or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, environment, public health or
safety, or State, local, or tribal governments or communities; (2)
create a serious inconsistency or otherwise interfere with an action
taken or planned by another agency; (3) materially alter the budgetary
impact of entitlements, grants, user fees, or loan programs or the
rights and obligations of recipients thereof; or (4) raise novel legal
or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the E.O.
DEA expects that this rule will have an annual effect on the
economy of $100 million or more in cost savings and therefore is an
economically significant regulatory action. The analysis of benefits
and costs is below. In the NPRM, DEA welcomed all comments that would
narrow the uncertainties in the presented analysis. Furthermore, DEA
asked prescribers, patients, and health care industry, including
insurance companies, eight specific questions. None of the comments
contained enough information for DEA to update the economic analysis.
Therefore, the analysis and conclusions below remain unchanged from the
analysis contained in the NPRM.
The economic, interagency, budgetary, legal, and policy
implications of this rule have been examined and it has been determined
to be a significant regulatory action under E.O. 12866, and therefore
has been submitted to the Office of Management and Budget (OMB) for
review.
I. Need for the Rule
As discussed above, the CARA was signed into law on July 22, 2016.
One provision of the CARA amended the CSA to allow for the partial
filling of prescriptions for schedule II controlled substances under
certain conditions, providing flexibilities to prescribers and
patients. Specifically, section 702(a) of the CARA amended 21 U.S.C.
829 by adding new subsection (f), which allows a pharmacist to
partially fill a prescription for a schedule II controlled substance
where requested by the prescribing practitioner or the patient.
Subsection (f) further provides that for such partial filling to be
lawful under the CSA, all of the following conditions must be
satisfied: (1) The partial filling must not be prohibited by State law;
(2) the prescription must be written and filled in accordance with the
CSA, DEA regulations, and State law; and (3) the total quantity
dispensed in all partial fillings must not exceed the total quantity
prescribed. In addition, subsection (f) provides that the remaining
portions of a partially filled prescription for a controlled substance
in schedule II, if filled, must be filled no later than 30 days after
the date on which the prescription is written, unless the prescription
is issued as an emergency oral prescription, in which case the
remaining portions, if filled, must be filled no later than 72 hours
after it was issued.
II. Alternative Approaches
When the prescriber requests the partial fill on the paper or
electronic prescription, or after consultation with
[[Page 46993]]
a pharmacist, the pharmacy's actions are straightforward. The
pharmacist dispenses the prescription according to the prescriber's
partial fill instructions and makes the required notations on the
prescription, and the pharmacy maintains the required dispensing
records. However, DEA considered three regulatory alternatives
regarding the required notifications when the partial fill is at the
request of the patient. DEA considered whether the pharmacist should:
(1) Notify the prescribing practitioner or the prescribing
practitioner's agent of the patient's request to partially fill the
prescription, and obtain the prescribing practitioner's consent for the
quantity; (2) notify the prescribing practitioner or the prescribing
practitioner's agent of the patient's partial fill request, but not
require the prescribing practitioner's consent; or (3) simply dispense
the partial fill as requested without any notification or consent. As
the pharmacist's requirement for notification or consent is the only
difference between the alternatives, the alternatives analysis below
only examines the estimated cost of notification or consent. A complete
discussion of benefits and costs is described in the following section.
Alternative 1: Obtain Prescribing Practitioner's Consent for the
Partial Fill Quantity Prior to Dispensing
The first alternative would require the prescribing practitioner's
consent for the quantity to be dispensed before the pharmacist
dispenses a partial fill at the patient's request. Upon receiving a
patient's request for a partial fill, the pharmacist would contact the
prescribing practitioner or the prescribing practitioner's agent, and
confirm that the prescribing practitioner concurs with the requested
partial fill quantity. After confirmation, the pharmacist would
dispense the partial fill and make the required notation on the
prescription. The notation includes the method of notification (e.g.,
telephone, email, voicemail) and the person notified.
DEA estimates obtaining consent would require six minutes from each
of the parties involved: the pharmacist to request consent, the
prescribing office to review the request and for the prescribing
practitioner or practitioner's agent to give consent, and the patient
to wait while consent is received. To estimate the cost, DEA used the
following labor wage and employment cost rates from the U.S. Department
of Labor, Bureau of Labor Statistics (BLS). The following occupations'
median hourly wages were noted: \9\
---------------------------------------------------------------------------
\9\ BLS, May 2018 National Occupational Employment and Wage
Estimates, United States. <a href="https://www.bls.gov/oes/current/oes_nat.htm">https://www.bls.gov/oes/current/oes_nat.htm</a>. (Accessed 2/6/2020.)
---------------------------------------------------------------------------
<bullet> Pharmacist requesting consent: 29-1051 Pharmacists,
$60.64.
<bullet> Prescriber's representative to give consent: 43-6033
Medical Secretaries, $17.19.\10\
---------------------------------------------------------------------------
\10\ In this alternative, while the prescriber would be involved
in providing consent, the time requirement on the prescriber is
assumed to be minimal, and thus excluded. The primary economic
impact would be based on the time requirement for the prescriber's
representative.
---------------------------------------------------------------------------
<bullet> Patient: 00-0000 All Occupations, $18.54.
Additionally, a load of 42.7 percent for benefits was applied to
the median hourly wages to obtain loaded median hourly wages below:
\11\
---------------------------------------------------------------------------
\11\ BLS, ``Employer Costs for Employee Compensation--September
2019'' (ECEC) reports that average benefits for private industry is
29.9 percent of total compensation. The 29.9 percent of total
compensation equates to 42.7 percent (29.9%/70.1%) load on wages and
salaries.
---------------------------------------------------------------------------
<bullet> Pharmacist requesting consent: 29-1051 Pharmacists,
$86.53.
<bullet> Prescriber's representative to give consent: 43-6033
Medical Secretaries, $24.53.
<bullet> Patient: 00-0000 All Occupations, $26.51.
Therefore, the estimated cost of obtaining consent (six minutes per
occurrence) would cost the pharmacy $8.65, the prescriber $2.45, and
the patient $2.65, for a total $13.85 per occurrence.
While DEA does not have a strong basis to estimate the number of
instances the patient will request partial filling of a prescription
for schedule II control substance, in the Cost Savings discussion
below, the estimated total prescriptions for potential partial filling
is 36,375,279. DEA used the midpoint between 0 and 100 percent--half
(18,187,640)--to estimate the cost savings. DEA does not know all the
reasons a patient may request a partial fill, but believes a patient
requesting a partial filling of a prescription for a schedule II
controlled substance may seek a partial fill because: the patient is
aware of the potential risks of excess opioids in the household, the
patient does not want excess opioids in the household, the patient
believes he or she will not need all the dosages prescribed, and there
is no additional cost or logistical burden as a result of the partial
fill. DEA further believes that patients are likely to follow the
instructions of prescribers, and estimates only a small minority of the
estimated 18,187,640 requests for partial fills will be at the request
of the patient. For the purposes of this analysis, DEA assumes 10
percent, or 1,818,764 partial fills will be at the request of the
patient. Applying the cost per occurrence to the number of occurrences,
this alternative is estimated to cost pharmacies approximately $15.7
million per year for the pharmacists to obtain consent, prescribing
practitioners approximately $4.5 million per year to give consent, and
patients $4.8 million while waiting for the pharmacist to obtain
consent from the prescribing practitioner or practitioner's agent for a
total $25 million per year. The table below summarizes this
calculation.
Table 1--Summary Calculation for Alternative 1
----------------------------------------------------------------------------------------------------------------
Loaded hourly Time required Cost per Number of Total cost
wage ($) (hours) occurrence ($) occurrences ($M)
----------------------------------------------------------------------------------------------------------------
Pharmacy........................ 86.53 0.1 8.65 1,818,764 15.7
Prescriber's representative..... 24.53 0.1 2.45 1,818,764 4.5
Patient......................... 26.51 0.1 2.65 1,818,764 4.8
-------------------------------------------------------------------------------
Total....................... N/A N/A 13.75 N/A 25.0
----------------------------------------------------------------------------------------------------------------
This alternative was not selected. It is contrary to the plain
language of the statutory text, which allows a patient to request a
partial fill without obtaining the practitioner's consent. Although
this alternative ensures consideration of the
[[Page 46994]]
partial fill by the prescribing practitioner, DEA believes this
alternative is unnecessarily burdensome. While DEA does not have a
basis to estimate the likelihood of the prescribing practitioner
denying consent for partial fills, DEA assumes denials would be rare.
The patient may request a partial fill for a variety of reasons, and a
partial fill request does not necessarily mean that the remaining
portions of the prescription will not be filled. Requiring consent
prior to the pharmacist's dispensing the partial fill would be
unnecessarily burdensome, and, thus, this alternative was not selected.
Alternative 2: Notify the Prescribing Practitioner of the Partial Fill
Quantity After Dispensing
The second alternative would require notification to the
prescribing practitioner or the prescribing practitioner's agent of the
quantity dispensed upon the patient's request for the partial fill. In
this scenario, the prescribing practitioner's consent for the partial
fill would not be required. Instead, the pharmacist would partially
fill the prescription based on the patient's request, notify the
prescribing practitioner or the prescribing practitioner's agent of the
quantity dispensed, and make the required notation on the prescription.
The notation is the same method as for Alternative 1.
DEA estimates notifying the prescribing practitioner will require
three minutes from each of the parties involved: the pharmacist to
contact the prescribing office to give notice and the prescribing
office to receive and review notice. Using the same BLS occupations and
loaded median hourly wages as Alternative 1, the estimated cost of each
notification (three minutes per occurrence) would cost the pharmacy
$4.33 and the prescriber $1.23 for a total $5.56 per occurrence.
Applying the same estimate of 1,818,764 partial fills, as in
Alternative 1, this alternative is estimated to cost pharmacies
approximately $7.9 million per year for the pharmacists to give notice
and prescribing practitioners approximately $2.2 million per year to
receive and review notice. The table below summarizes this calculation.
Table 2--Summary Calculation for Alternative 2
----------------------------------------------------------------------------------------------------------------
Loaded hourly Time required Cost per Number of Total cost
wage ($) (hours) Occurrence ($) occurrences ($M)
----------------------------------------------------------------------------------------------------------------
Pharmacy........................ 86.53 0.05 4.33 1,818,764 7.9
Prescriber's representative..... 24.53 0.05 1.23 1,818,764 2.2
-------------------------------------------------------------------------------
Total....................... N/A N/A 5.56 N/A 10.1
----------------------------------------------------------------------------------------------------------------
This alternative was not selected. DEA believes that this
alternative is also unnecessarily burdensome. Although this alternative
would ensure that the prescribing practitioner is made aware of the
partial filling of the prescription and could react to this information
if needed, it would cause an additional compliance-burden on both the
pharmacy and prescribing practitioner.
Alternative 3: Dispense Partial Fill as Requested Without Consent of,
or Notification to, the Prescribing Practitioner
The third alternative would not require the consent of, or
notification to, the prescribing practitioner described in Alternatives
1 or 2, respectively. In this alternative, the pharmacist would
partially fill the prescription based on the patient's request and make
the required notation on the prescription. This alternative results in
no notification-related cost to the pharmacy or prescriber.
This alternative was selected. Although a partial fill at the
request of the patient may represent a departure from the prescribing
practitioner's dispensing instructions, this alternative is the least
burdensome to the pharmacy, prescribing practitioner, and the patient.
Additionally, a partial fill does not preclude the eventual dispensing
of the full amount prescribed. Under this rule, patients requesting a
partial fill would be entitled to request that the pharmacist fill the
remainder of the prescription within a 30-day window. This alternative
would result in no additional consent or notification-related costs and
would not impose dispensing delays on patients requesting a partial
fill. A further discussion of the benefits and costs of this
alternative is described below. While the initial proposed alternative
did not include the possibility of a parent or legal guardian making
the request on behalf of a minor and a caregiver named in a medical
power of attorney making the request on behalf of an adult patient, the
inclusion of these provisions in the final rule does not change the
advantages of this alternative or the economic analysis discussed
below. When the patient is a minor or an adult patient who has a
caregiver, the parent, legal guardian, or caregiver is often the person
filling the prescription and may request partial filling with minimal
economic impact.
III. Analysis of Benefits and Costs
This rule allows partial fills of prescriptions for schedule II
controlled substances at the request of the patient (including the
parent or legal guardian of a minor or the caregiver of an adult named
in a medical power of attorney) or the prescribing practitioner, if not
prohibited by State law. The rule also includes time limitations on
filling the remaining portions of a partially filled prescription for a
schedule II controlled substance, and additional provisions for how a
practitioner may request that a prescription for a schedule II
controlled substance be partially filled, and how a pharmacy must
record the partial filling of a prescription for a schedule II
controlled substance.
DEA examined the benefits, costs, and cost savings associated with
this rule.
Benefits
DEA does not know all the reasons a prescriber or patient might
request a partial fill of a prescription. However, as discussed in the
Cost Savings section below, a significant portion of filled opioid
prescriptions go unused, leading to the excess opioids being kept by
the patient that could end up being for improper use, diversion, or
improper disposal. Partial filling is expected to reduce the quantity
of unused schedule II controlled substances, which would decrease the
risk of diversion, and the risk that patients or others may develop
physical dependence or an addiction to prescribed scheduled II
controlled substances.
[[Page 46995]]
The supply of unused drugs in U.S. households contributes to
concerns related to opioids and illicit drug use. Keeping and storing
unused medications in households poses several risks related to misuse,
diversion, accidental overdose, and consumption of spoiled
substances.\12\ Many patients receive their first opioid prescription
after a surgical procedure and frequently retain the majority of unused
medication, which could potentially be sold illegally or misused by the
patient. In addition, unused medication can be diverted and used by
other members of the patient's household, friends of the patient, or
sold. According to the National Institute on Drug Abuse, 21 to 29
percent of patients prescribed opioids for chronic pain misuse
them,\13\ between 9.1 and 12.2 percent prescribed opioids for chronic
pain develop an opioid use disorder,\14\ an estimated 4 to 6 percent
who misuse prescription opioids transition to
heroin,<SUP>15 16 17</SUP> and about 80 percent of people who use
heroin first misused prescription opioids.\18\ According to one journal
article, ``multiple studies have reported an increased risk of new
persistent opioid use after prescription of opioids for acute pain in
opioid na[iuml]ve patients. Even patients who undergo relatively minor
low-pain surgery are at increased risk of long term opioid use.'' \19\
According to the Substance Abuse and Mental Health Administration
(SAMHSA), 47.2 percent of people who misused pain relievers in the past
year obtained the last pain reliever they misused ``from a friend or
relative in some way (i.e., being given them, buying them, or taking
them without asking).'' \20\ Also, although opioid medications are
effective in managing acute pain after surgery, even short-term use of
opioids can lead to long-term dependence.\21\
---------------------------------------------------------------------------
\12\ ``Safe Disposal of Unused Controlled Substances: Current
Challenges and Opportunities for Reform,'' Avalere, <a href="http://www.ncdoi.com/osfm/safekids/documents/omd/safedisposalofunusedcontrolledsubstancesreport.pdf">http://www.ncdoi.com/osfm/safekids/documents/omd/safedisposalofunusedcontrolledsubstancesreport.pdf</a>.
\13\ Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, van der
Goes DN. Rates of opioid misuse, abuse, and addiction in chronic
pain: a systematic review and data synthesis. Pain 156(4):569-576.
(2015).
\14\ Katherine M Keyes, and Caroline Rutherford. Prevalence of
addiction in chronic pain: reanalysis of Vowles et al., 2015. Pain
163(5):e693-e695. (2022).
\15\ Muhuri PK, Gfroerer JC, Davies MC. Associations of
Nonmedical Pain Reliever Use and Initiation of Heroin Use in the
United States. CBHSQ Data Rev. August 2013.
\16\ Cicero TJ, Ellis MS, Surratt HL, Kurtz SP. The Changing
Face of Heroin Use in the United States: A Retrospective Analysis of
the Past 50 Years. JAMA Psychiatry 71(7):821-826. (2014).
\17\ Carlson RG, Nahhas RW, Martins SS, Daniulaityte R.
Predictors of transition to heroin use among initially non-opioid
dependent illicit pharmaceutical opioid users: A natural history
study. Drug Alcohol Depend 160:127-134.doi:10.1016 (2016).
\18\ See note 15.
\19\ ``Prescription of opioids for acute pain in opioid
na[iuml]ve patients,'' 2019, Carlos A Pino, MD, Melissa Covington,
MD, <a href="http://Uptodate.com">Uptodate.com</a>, Wolters Kluwer. <a href="https://www.uptodate.com/contents/prescription-of-opioids-for-acute-pain-in-opioid-naive-patients">https://www.uptodate.com/contents/prescription-of-opioids-for-acute-pain-in-opioid-naive-patients</a>.
\20\ SAMHSA, The National Survey on Drug Use and Health: 2020
<a href="https://www.samhsa.gov/data/data-we-collect/nsduh-national-survey-drug-use-and-health">https://www.samhsa.gov/data/data-we-collect/nsduh-national-survey-drug-use-and-health</a>.
\21\ Empowering Post-Surgical Patients to Improve Opioid
Disposal: A Before and After Quality Improvement Study. Jessica M.
Hasak, Carrie L. Roth Bettlach, Katherine B. Santosa, Ellen L.
Larson, Jean Stroud, Susan E. Mackinnon. Journal of the American
College of Surgeons 2017.
---------------------------------------------------------------------------
The total U.S. economic burden (healthcare costs, criminal justice
costs, and lost productivity costs) of prescription opioid misuse in
2013 was estimated to be $78.5 billion, based on the 1.935 million
Americans estimated to meet the American Psychiatric Association's
Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
for opioid use disorder.\22\ This economic burden equates to
approximately $41,600 per person with opioid use disorder.\23\ DEA
estimates approximately $41,600 in societal benefit accrues each time
we prevent an individual from developing opioid use disorder. This rule
is expected to lower the prevalence of opioid misuse and thereby reduce
rates of opioid addiction. While DEA has no basis to quantify the
amount of misuse that will be prevented, DEA anticipates that
reductions in opioid dispensing will reduce the amount of unused opioid
medications in American homes, thereby reducing opportunities for
medication sharing and other forms of diversion. This, in turn will
have a real and significant benefit by reducing misuse and development
of opioid use disorder.
---------------------------------------------------------------------------
\22\ Florence CS, Zhou C, Luo F & Xu L, The Economic Burden of
Prescription Opioid Overdose, Abuse, and Dependence in the United
States, 2013, 54 Med Care 901 (2016). DEA's 2017 National Drug
Threat Assessment also references this estimate for total economic
burden of prescription drug misuse.
\23\ $78.5 billion/1.935 million patients = $40,568 per patient.
---------------------------------------------------------------------------
Cost Savings
This rule is estimated to lower the amount of schedule II
medications dispensed and, therefore, expenditures on prescriptions. It
is also expected to reduce the number of unused schedule II controlled
substances requiring disposal. To quantify the cost savings, DEA
estimated the cost of excess medicine and calculated the approximate
percent cost savings opportunity that may be realized by this rule.
In 2017, 163,683,029 prescriptions for schedule II controlled
substances were filled for ``acute'' pain, with a total retail cost of
$11,807,297,373, or an average retail cost of $72.14 per
prescription.\24\ The prescription data includes a data field that
indicates whether the condition being treated is ``acute'' or
``chronic.'' The figure excludes schedule II controlled substances
generally prescribed for chronic conditions, i.e., amphetamine,
lisdexamfetamine, methamphetamine, and methylphenidate. DEA believes
prescriptions for ``acute'' conditions are more likely to be partially
filled. Therefore, DEA estimates 163,683,029 prescriptions represent
the total number of prescriptions that may be partially filled per
year. However, many States have already passed laws or adopted
regulations limiting the quantity of schedule II controlled substances
that may be dispensed pursuant to a prescription. For example, in 2016,
Massachusetts became the first state to pass a law to limit first time
opioid prescriptions to seven days.\25\ Since 2016, many other States
have passed similar laws limiting the prescribing of opioids for acute
pain. These limits generally range from a 3 to 14-day supply.\26\ As of
September 2019, 36 States have placed limits on the amount of opioids
that can be prescribed by doctors.\27\ The limits in five of those
States apply only to Medicaid recipients, and two States have no pill
or day limits, but require doctors to prescribe the lowest effective
dose.\28\ Based on review of state limits for prescribing of opioids,
DEA estimates there are 34 states with pill or day limits in place,
representing 68.7 percent of the U.S. population.\29\ DEA believes
[[Page 46996]]
partial fill provisions under this rule are likely to have an impact on
the remaining states without opioid prescription limits, representing
31.3 percent of the U.S. population. Applying this percentage, DEA
estimates 51,232,788 (31.3 percent) of the 163,683,029 total
prescriptions may be partially filled. According to a 2017 study of
post-surgical patients who were prescribed opioids, only 29 percent
used the entire prescription, leaving 71 percent of post-surgical
patients with excess opioids.\30\ The study found that patients
prescribed opioids after surgery consumed, on average, only 33 percent
of the prescribed medication.\31\ Based on that finding, DEA estimates
71 percent of patients will not use all controlled substance
prescriptions. DEA therefore estimates that 36,375,279 (71 percent) of
the estimated 51,232,788 prescriptions in states without controlled
substance prescribing or dispensing limits will not be fully utilized,
presenting an opportunity for cost savings from partial fills.
---------------------------------------------------------------------------
\24\ IQVIA Data 2017. Prescriptions for ``acute pain'' were used
to differentiate from ``chronic'' conditions, which are limited to
prescriptions for amphetamine. $11,807,297,373/163,683,029 = $72.14.
\25\ ``Opioid Prescribing Limits Across the States,'' Marilyn
Bullock, PharmD, BCPS, FCCM, 2/5/2019, <a href="http://pharmacytimes.com">pharmacytimes.com</a>.
\26\ Ibid.
\27\ ``Opioid prescription limits and policies by state.''
<a href="https://ballotpedia.org/Opioid_prescription_limits_and_policies_by_state">https://ballotpedia.org/Opioid_prescription_limits_and_policies_by_state</a>. (Accessed 2/3/
2020.)
\28\ Ibid.
\29\ For the purposes of this discussion, ``State'' includes
Puerto Rico and the District of Columbia. Population estimates are
based on the U.S. Census Bureau's 2019 population estimates. The 34
States that have pill or day limits are: Alaska, Arizona, Colorado,
Connecticut, Delaware, Florida, Hawaii, Indiana, Iowa, Kentucky,
Louisiana, Maine, Massachusetts, Michigan, Minnesota, Missouri,
Nebraska, Nevada, New Hampshire, New Jersey, New York, North
Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South
Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington,
West Virginia.
\30\ Empowering Post-Surgical Patients to Improve Opioid
Disposal: A Before and After Quality Improvement Study. Jessica M.
Hasak, Carrie L. Roth Bettlach, Katherine B. Santosa, Ellen L.
Larson, Jean Stroud, Susan E. Mackinnon. Journal of the American
College of Surgeons 2017. The purpose of the study was to determine
whether providing an educational brochure would improve disposal
methods of excess opioids. The study found 35 of 128 participants
not given the educational brochure used the entire prescription, and
40 of 130 participants given the educational brochure used the
entire prescription. Combining the two groups, 75 (29%) of 258
participants used the entire prescription.
\31\ Ibid.
---------------------------------------------------------------------------
Assuming a typical partial fill request is for 50 percent of the
prescription, and as discussed above, a patient is not likely to return
to fill the remaining portion of the prescription, the estimated
savings from the remaining unfilled portions is 50 percent of the
average cost per prescription ($72.14) or $36.07. Multiplying the
estimated savings per prescription of $36.07 by the number of
prescriptions available for cost savings (36,375,279) results in
$1,312,035,331 in potential cost savings per year. However, DEA does
not have a basis to estimate the actual number or percentage of
prescriptions for schedule II controlled substances issued in these
states that will be partially filled, and therefore cannot estimate
likely aggregate savings based on this methodology. For the purposes of
this analysis, DEA estimates 50 percent of potential savings, or
$656,028,165 (representing 18,187,640 partially filled prescriptions)
will be realized as annual cost savings from reduced schedule II
controlled substance dispensing. DEA does not have a basis to estimate
the impact of this rule on payments to pharmacies, in terms of price
per dosage units, co-pays, insurance reimbursements, etc., or who would
realize the cost savings.
In addition to the cost savings from not dispensing remaining
portions of partially filled prescriptions, DEA anticipates cost
savings from the reduced need to dispose of unused medications.
Patients dispose of unused drugs in a variety of ways, including
throwing them in the trash, flushing them down the toilet, pouring them
down the sink drain, taking them to the pharmacy or physician's office,
or taking them to a drug take back site or event. In a two-phased study
using a convenience sample in Southern California, researchers found
that only 13 percent of people surveyed either disposed of their
medications by taking them to the pharmacy or to the physician's
office.\32\ For the purpose of this analysis, DEA assumes that only 13
percent of people with leftover schedule II medications dispose of
their unused medications in this way. It is likewise estimated that
two-thirds of dispensed medications in the United States are unused by
patients.\33\ Based on DEA's assumption that a typical partial fill
represents 50 percent of the prescription, and that the average
partially filled prescription represents 67 pills, DEA estimates the
average number of excess pills is 34 (50% x 67 pills) per full
prescription filled.\34\ To calculate the total cost savings for
patients not needing to dispose of their unused schedule II controlled
substances, DEA first multiplied the estimated number of partial fill
prescriptions by the average disposal pill count to get a total of
618,379,760 pills (18,187,640 x 34). To estimate the number of pills
being disposed of by patients through pharmacies, physician offices, or
take back days, DEA multiplied the total number of pills (618,679,760)
by 13 percent to get 80,389,369 pills. Using the average cost per
disposal of $5.60/pound collected,\35\ and the estimate of pound/pill
of .0069,\36\ the total cost savings for unused pills not needing to be
disposed of is $3,106,245 (80,389,369 x $5.60 x .0069). The remaining
87 percent of pills that are not properly disposed of are assumed to be
either thrown away in the trash (62.7 percent), flushed down the toilet
(18 percent), disposed of in the sink (4.3 percent), not disposed of
and stored (17.4 percent), and other (8 percent).\37\ Therefore, the
total annual cost savings of this rule is $659,134,410 ($656,028,165 +
$3,106,245).
---------------------------------------------------------------------------
\32\ ``Taking Stock of Medication Wastage: Unused Medications in
US Households.'' NeuroImage, Academic Press, 16 Oct. 2014,
<a href="http://www.sciencedirect.com/science/article/pii/S1551741114003337?via%3Dihub">www.sciencedirect.com/science/article/pii/S1551741114003337?via%3Dihub</a>.
\33\ Ibid.
\34\ IMS Health IQVIA Data 2017. The 67 average number of pills
dispensed was determined by dividing the total number of extended
units in 2017 by the total number of prescriptions (10,921,740,149/
163,683,029). From IQVIA's data dictionary, the term ``extended
units''--``represents the total number (new plus refill) of
dispensed tablets, capsules, milliliters, and so forth. For solids,
this is the number of tablets; for creams, grams; and liquids,
mls.''
\35\ Siler, S., Duda, S., Brown, R., Gbemudu, J., Weiner, S., &
Glaudemans, J. (n.d.). Safe Disposal of Unused Controlled
Substances. Retrieved September 21, 2018, from <a href="http://www.ncdoi.com/osfm/safekids/documents/omd/safedisposalofunusedcontrolledsubstancesreport.pdf">http://www.ncdoi.com/osfm/safekids/documents/omd/safedisposalofunusedcontrolledsubstancesreport.pdf</a>.
\36\ <a href="http://michigan-open.org/statewide-drug-takeback-event-nets-900-pounds-of-opioids-more/">http://michigan-open.org/statewide-drug-takeback-event-nets-900-pounds-of-opioids-more/</a>.
\37\ ``Taking Stock of Medication Wastage: Unused Medications in
US Households.'' NeuroImage, Academic Press, 16 Oct. 2014,
<a href="http://www.sciencedirect.com/science/article/pii/S1551741114003337?via%3Dihub">www.sciencedirect.com/science/article/pii/S1551741114003337?via%3Dihub</a>. Percentages are of improper disposal
methods only. There were other choices on the survey: take it to the
pharmacy (11.2 percent) and take it to the physician's office (1.8
percent). The percentages do not add to 100 percent because
respondents were allowed to select more than one method.
---------------------------------------------------------------------------
Costs
DEA estimates there is a cost to prescribers associated with the
time burden of writing instructions for partial fill prescriptions.
Partial filling of a prescription for a schedule II controlled
substance, pursuant to this rule, may be requested by the prescriber or
the patient. The prescriber may request a partial fill by specifying
the quantity to be dispensed in the partial filling on the face of the
written prescription or in the pharmacy's electronic records, in the
written record or the pharmacy's electronic records of the emergency
oral prescription, or in the record of the electronic prescription
record, along with other information required in 21 CFR 1306.05. A
practitioner may authorize a partial fill at a date after which the
prescription was issued, after consultation with a pharmacist. While
any additional time to specify the quantity to be dispensed in the
partial filling may be minimal, especially when viewed in relation to
the entire duration of the medical interaction between the prescriber
and the patient, DEA estimates each partial fill requested by the
prescriber will require 10 additional seconds for the prescriber to
specify the quantity to be dispensed. Based on BLS' mean hourly wage
for ``29-1060 Physicians and Surgeons'' of $101.43 and a 42.7 percent
load for benefits, the
[[Page 46997]]
estimated loaded hourly wage for a prescriber is $144.74.\38\
Therefore, the 10 additional seconds to specify the quantity to be
dispensed equates to $0.40.\39\ As discussed in the Cost Savings
discussion above, DEA does not have a basis to estimate the percentage
of the estimated 36,375,279 prescriptions per year available for
partial filling that would be partially filled pursuant to this rule.
Therefore, for the purposes of this analysis, DEA estimates the mid-
point (50 percent), or 18,187,640 prescriptions per year, will be
partially filled at the request of the prescriber at an annual cost of
$7,275,056.
---------------------------------------------------------------------------
\38\ BLS, May 2018 National Occupational Employment and Wage
Estimates, United States. <a href="https://www.bls.gov/oes/current/oes_nat.htm">https://www.bls.gov/oes/current/oes_nat.htm</a>. (Accessed 2/6/2020.) BLS, ``Employer Costs for Employee
Compensation--September 2019'' (ECEC) reports that average benefits
for private industry is 29.9 percent of total compensation. The 29.9
percent of total compensation equates to 42.7 percent (29.9%/70.1%)
load on wages and salaries. $101.43 x 1.427 = $144.74. The
``median'' hourly rate is generally preferred. However, the median
hourly rate for this occupation code was not available; thus, the
``mean'' was used. While it is likely some of the partial fill
instructions will be written by a mid-level practitioner, i.e.,
nurse practitioner, physician's assistant, etc., or a nurse (in
preparation for the prescriber's signature), DEA believes this
loaded hourly rate is a reasonably conservative estimate.
\39\ 10 seconds x (1 hour/3,600 seconds) x $144.74/hour = $0.40.
---------------------------------------------------------------------------
When a prescribing practitioner has properly specified his or her
intent to partially fill a prescription for a schedule II controlled
substance, this rule will require the pharmacist to record the partial
filling in a manner similar to that required under the existing
regulations for other circumstances.\40\ Specifically, the dispensing
pharmacist must make a notation of the quantity dispensed on the face
of the written prescription or in the pharmacy's electronic records, in
the written record or the pharmacy's electronic records of the
emergency oral prescription, or in the record of the electronic
prescription (similar to current requirements under 21 CFR 1306.13(a)
when the pharmacist is unable to supply the full quantity called for in
a prescription for a schedule II controlled substance). When the
pharmacist partially fills a prescription, after the prescriber has
conveyed this request in a consultation with a pharmacist in accordance
with paragraph (b)(3), the pharmacist must note the following:
``Authorized by Practitioner to Partial Fill,'' the name of the
practitioner, the date and time of the discussion, and the pharmacist's
initials. Also, for each such partial filling (whether requested by the
prescriber on the prescription or after consultation with the
pharmacist), the pharmacy must maintain a record with the date of each
dispensing, the name or initials of the individual who dispensed the
substance, and all other information required by 21 CFR 1306.22(c) for
prescription refills of schedule III and IV controlled substances. DEA
believes the most common scenario will be that the partial fill
information is entered into a computerized system, in an existing data
field; then, an adhesive label with relevant information will be
printed, and subsequently affixed to the prescription container. When
partially filling a prescription for a schedule II controlled substance
at the patient's request, the pharmacist must make the same notation on
the prescription as when partially filling a prescription at the
request of the prescribing practitioner, along with additional
information indicating that the patient requested the partial fill.
While DEA believes documenting the quantities dispensed for each filled
prescription is a usual and ordinary activity for a pharmacist, DEA
estimates that it may require 10 additional seconds for a pharmacist to
record a partial fill, pursuant to this rule. Based on an estimated
loaded median hourly rate of $86.53 for a pharmacist, from the
alternatives analysis above, the 10 additional seconds to record
partial fills equates to $0.24.\41\ As discussed above, DEA does not
have a basis to estimate the percentage of the estimated 36,375,279
prescriptions per year that will be partially filled. Therefore, for
the purposes of this analysis, DEA estimates the mid-point (50
percent), or 18,187,640 prescriptions per year will be partially
filled, requiring recording of the partial fill by the pharmacist at an
annual cost of $4,365,034.
---------------------------------------------------------------------------
\40\ See note 2.
\41\ 10 seconds x (1 hour/3,600 seconds) x $86.53/hour = $0.24.
---------------------------------------------------------------------------
If a patient received a partial fill pursuant to this rule, and
then returns to the pharmacy to receive another partial fill, or the
remainder of the initial prescription, the pharmacist will require some
additional time to fill the prescription. For example, if filling the
remainder of the partial fill required 10 additional minutes, based on
the estimated loaded median hourly rate of $86.53 for a pharmacist,
that additional time will equate to a cost of $14.42. Additionally,
there will be a similar cost to the patient to potentially make an
additional trip to the pharmacy and waiting for the prescription to be
filled. However, DEA estimates these additional interactions will be
minimal. As discussed earlier in reference to the 2017 study of post-
surgical patients who were prescribed opioids, 71 percent of patients
in the study did not use the entire prescription, and on average the
patients only used 33 percent of the prescribed opioids. If prescribers
and patients randomly asked for partial fills, only a small minority of
patients will return for the remainder of the prescription. However,
DEA does not anticipate the request for partial fills, at the request
of the prescriber or the patient, to be random. Rather, DEA anticipates
prescribers will exercise professional judgment and foresight in
determining when a partial fill is best suited. DEA does not believe a
partial fill will be requested by the prescriber when the prescriber
believes the patient is likely to need all of the prescribed
medication. Furthermore, while this rule will permit patients to
request partial fills, DEA believes patients are unlikely to request a
partial fill. Rather, the patient will follow the prescriber's
instruction, based on consultation between the prescriber and the
patient. Therefore, DEA believes any increase in the number of patient-
pharmacy interactions related to patient-requested partial fills and
resulting burden would likely be de minimis. DEA estimates the total
cost of this rule is $11,640,090 ($7,275,056 to prescribers and
$4,365,034 to pharmacies) per year.
Discussion of Uncertainties
This analysis evaluates the economic impact of activities that were
previously not permitted. Therefore, DEA does not have a strong basis
to estimate the level of participation in these activities, including
partial filling of prescriptions for schedule II controlled substances
by prescribers and patients, and how insurance companies will react to
these partial filling of prescriptions.
This analysis is highly sensitive to the percentage of
prescriptions being partially filled, and the percentage of partially
filled prescriptions with patients returning for remainder of the
partially filled prescription.
For example, if prescribers and patients in States with no opioid
prescription pill or day limits requested a partial fill of 50 percent
of the prescription amount for all 71 percent of prescriptions where
not all drugs are used, the estimated cost savings from not dispensing
the full prescriptions increases to $1,312,035,331 (representing
36,375,279 partially filled prescriptions). Because DEA does not have a
good basis to estimate the potential cost savings that will be
realized, for the purposes of this analysis, DEA assumes the mid-point
(50 percent), or $656,028,165
[[Page 46998]]
(representing 18,187,640 partially filled prescriptions) will be
realized as cost savings from not dispensing excess schedule II
controlled substances. An estimate of zero percent will result in zero
cost savings. As the percentage of cases where partial fills are
requested increases, the estimated cost savings increase
proportionally.
DEA anticipates prescribers will exercise professional judgment and
foresight in determining when a partial fill is best suited. DEA does
not believe a partial fill will be requested by the prescriber when the
prescriber believes the patient is likely to need all of the prescribed
medicine, resulting in a minimal number of patients returning for the
remainder of the partially filled prescription. Furthermore, while this
rule will permit patients to request partial fills, DEA believes
patients are unlikely to request a partial fill. Rather, the patient
will follow the prescriber's instruction, based on consultation between
the prescriber and the patient.
Finally, this analysis excluded any anticipated impact of this rule
on payments to pharmacies, in terms of price per dosage units, co-pays,
insurance reimbursements, etc., or who would realize the cost savings.
Summary
In summary, DEA estimates that the total cost savings of this rule
will be $659 million per year, and the total cost will be $12 million
per year, for a net cost savings of $647 million per year (rounded to
the nearest million dollars) over the next five years. Due to the fluid
nature of the national opioid crisis and legislative activity in State
government, DEA believes using a five-year term for the analysis is
reasonable. At a three percent discount rate, the net present value of
the cost savings over a 5-year period is $2,965 million. At a seven
percent discount rate, the present value of the cost savings is $2,655
million.
Executive Order 12988, Civil Justice Reform
This rule meets the applicable standards set forth in sections 3(a)
and 3(b)(2) of Executive Order 12988, to eliminate drafting errors and
ambiguity, minimize litigation, provide a clear legal standard of
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of Executive Order 13132. This rule does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or the distribution of power
and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of Executive Order 13175. It does not have substantial
direct effects on one or more Indian tribes, or on the distribution of
power and responsibilities between the Federal government and Indian
tribes.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act, 5 U.S.C. 601-612, has reviewed this rule and by approving it,
certifies that it will not have a significant economic impact on a
substantial number of small entities.
This rule includes provisions regarding partial fill of
prescriptions for schedule II controlled substances. This rule will
allow partial fills of such prescriptions at the request of the patient
or the prescribing practitioner, if not prohibited by State law. A
request for partial fill can be made by the patient, a caregiver named
in an adult patient's medical power of attorney, or parent or legal
guardian of a minor patient. This rule also includes time limitations
on filling the remaining portions of a partially filled prescription
for a schedule II controlled substance and additional provisions for
how a practitioner may request that a prescription for a schedule II
controlled substance be partially filled, how a patient may request
that a prescription for a schedule II controlled substance be partially
filled, and how a pharmacy must record the partial filling of a
prescription for a schedule II controlled substance. While not all
practitioners may write prescriptions with partial fill instructions,
and not all pharmacies may receive prescriptions for partial fill,
these registrants (or entities that employ these registrants) will
still be subject to the partial fill provisions contained in this rule.
This rule primarily affects prescribers of schedule II controlled
substances and the pharmacies that fill those prescriptions. While
prescribers are generally individual practitioners, for the purposes of
this analysis, DEA includes industries that employ prescribers. In
Table 3, DEA estimates the industries that will be affected by this
rule, as described by the North American Industry Classification System
(NAICS). This list is not intended to include an exhaustive list of all
employers of prescribers of schedule II controlled substances, but
rather a representation of primary industries that employ them.
Table 3--Affected Industries, Six-Digit NAICS Code
------------------------------------------------------------------------
NAICS NAICS description.
------------------------------------------------------------------------
446110....................... Pharmacies and Drug Stores.
621111....................... Offices of Physicians (except Mental
Health Specialists).
621210....................... Offices of Dentists.
621491....................... HMO Medical Centers.
621493....................... Freestanding Ambulatory Surgical and
Emergency Centers.
622110....................... General Medical and Surgical Hospitals.
------------------------------------------------------------------------
The U.S. Census Bureau's Statistics of U.S. Businesses (SUSB)
publishes the number of firms, employment, and revenue by firm size and
industry. To estimate the number of small businesses affected, DEA
compared the 2012 SUSB data, the most recent data available containing
revenue by firm size and industry,\42\ to the U.S. Small Business
Administration (SBA) size standards.\43\ DEA estimates a total 326,033
entities,
[[Page 46999]]
of which 318,362 are small entities, will be affected by this rule.
Table 4 details the number of entities, SBA size standard, and
estimated number of small entities for each affected industry.\44\
---------------------------------------------------------------------------
\42\ ``Number of small businesses: Small entity counts,
employment, and revenues . . . number of small entities when the
size standard is based on revenue [Link to: <a href="https://www2.census.gov/programs-surveys/susb/tables/2012/us_6digitnaics_r_2012.xlsx">https://www2.census.gov/programs-surveys/susb/tables/2012/us_6digitnaics_r_2012.xlsx</a>].''
<a href="https://advocacy.sba.gov/resources/the-regulatory-flexibility-act/rfa-data-resources-for-federal-agencies">https://advocacy.sba.gov/resources/the-regulatory-flexibility-act/rfa-data-resources-for-federal-agencies</a>. (Accessed 2/4/2020.)
\43\ U.S. Small Business Administration, Table of Small Business
Size Standards Matched to North American Industry Classification
System Codes, Effective August 19, 2019. <a href="https://www.sba.gov/document/support--table-size-standards">https://www.sba.gov/document/support--table-size-standards</a>. (Accessed 2/4/2020.)
\44\ For the purposes of this analysis, ``firms'' and
``entities'' are used synonymously.
Table 4--Estimated Number of Affected Small Entities
----------------------------------------------------------------------------------------------------------------
SBA size
standard,
NAICS NAICS description Firms annual Small entities
revenue ($M)
----------------------------------------------------------------------------------------------------------------
446110...................... Pharmacies and Drug Stores........ 18,852 30.0 18,503
621111...................... Offices of Physicians (except 174,901 12.0 170,287
Mental Health Specialists).
621210...................... Offices of Dentists............... 125,151 8.0 124,689
621491...................... HMO Medical Centers............... 104 35.0 81
621493...................... Freestanding Ambulatory Surgical 4,121 16.5 3,603
and Emergency Centers.
622110...................... General Medical and Surgical 2,904 41.5 1,199
Hospitals.
-----------------------------------------------
Total................... .................................. 326,033 N/A 318,362
----------------------------------------------------------------------------------------------------------------
Partial filling of a prescription for a schedule II controlled
substance, pursuant to this rule, may be requested by the prescriber or
the patient. The prescriber may request a partial fill by specifying
the quantity to be dispensed in the partial filling on the face of the
written prescription, written record of the emergency oral
prescription, or in the electronic prescription record, along with
other information required in 21 CFR 1306.05. A practitioner may
authorize a partial fill at a date after which the prescription was
issued, after consultation with a pharmacist. While any additional time
to specify the quantity to be dispensed in the partial filling may be
minimal, especially when viewed in relation to the entire duration of
the medical interaction between the prescriber and the patient, DEA
estimates each partial fill requested by the prescriber will require 10
additional seconds for the prescriber to specify the quantity to be
dispensed. As discussed in the Costs section above, based on BLS' mean
hourly wage for ``29-1060 Physicians and Surgeons'' of $101.43 and a
42.7 percent load for benefits, the estimated loaded hourly wage for a
prescriber is $144.74. Therefore, the 10 additional seconds to specify
the quantity to be dispensed equates to $0.40.\45\ As discussed in the
Cost Savings discussion above, DEA does not have a basis to estimate
the percentage of the estimated 36,375,279 prescriptions per year
available for partial filling that would be partially filled pursuant
to this rule. Therefore, for the purposes of this analysis, DEA
estimates the mid-point (50 percent), or 18,187,640 prescriptions per
year will be partially filled at the request of the prescriber at a
cost of $7,275,056. This cost of $7,275,056 equates to an average of
$24 per firm, excluding pharmacies.\46\
---------------------------------------------------------------------------
\45\ 10 seconds x (1 hour/3,600 seconds) x ($101.43/hour x
1.427) = $0.40.
\46\ 326,033 total affected firms--18,852 pharmacies and drug
stores = 307,181 firms that employ prescribers. $7,275,056/307,181 =
$24 (rounded to nearest whole dollar).
---------------------------------------------------------------------------
When a prescribing practitioner has properly specified his or her
intent to partially fill a prescription for a schedule II controlled
substance, this rule will require the pharmacist to record the partial
filling in a manner similar to that required under the existing
regulations for other circumstances.\47\ Specifically, the dispensing
pharmacist must make a notation of the quantity dispensed on the face
of the written prescription or in the pharmacy's electronic records, in
the written record or the pharmacy's electronic records of the
emergency oral prescription, or in the record of the electronic
prescription (similar to current requirements under 21 CFR 1306.13(a)
when the pharmacist is unable to supply the full quantity called for in
the schedule II prescription). Also, for each such partial filling, the
pharmacy must maintain a record with the date of each dispensing, the
name or initials of the individual who dispensed the substance, and all
other information required by 21 CFR 1306.22(c) for schedule III and IV
prescription refills. DEA believes the most common scenario will be
that the partial fill information is entered into a computerized
system, in an existing data field; then, an adhesive label with
relevant information will be printed, and subsequently affixed to the
prescription container. When partially filling a prescription for a
schedule II controlled substance at the patient's request, the
pharmacist must make the same notation on the prescription as when
partially filling a prescription at the request of the prescribing
practitioner, along with additional information indicating that the
patient requested the partial fill. While DEA believes documenting the
quantities dispensed for each filled prescription is a usual and
ordinary activity for a pharmacist, DEA estimates that it may require
10 additional seconds for the pharmacist to record a partial fill,
pursuant to this rule. Based on an estimated loaded median hourly rate
of $86.53 for a pharmacist, from the alternatives analysis above, the
10 additional seconds to record partial fills equates to $0.24.\48\ As
discussed in the Cost Savings section above, DEA does not have a basis
to estimate the percentage of the estimated 36,375,279 prescriptions
per year that will be partially filled. Therefore, for the purposes of
this analysis, DEA estimates the mid-point (50 percent), or 18,187,640
prescriptions per year will be partially filled, requiring recording of
the partial fill by the pharmacist at an annual cost of $4,365,034.
This cost of $4,365,034 equates to an average of $232 per firm for
pharmacies.\49\
---------------------------------------------------------------------------
\47\ See note 2.
\48\ 10 seconds x (1 hour/3,600 seconds) x ($60.64/hour x 1.427)
= $0.24.
\49\ $4,365,034/18,852 = $232 (rounded to nearest whole dollar).
---------------------------------------------------------------------------
The average cost of $24 per firm for prescribers, and $232 per firm
for pharmacies is a very high estimate for small entities, as small
prescribing firms are expected to request less than an average number
of partial fills per firm, and small pharmacies are expected to fill
less than average partial fills per firm. Although these are high
estimates, these costs were compared to the average annual revenue for
the smallest of small entities. The average cost ranges from 0.009
percent of revenue for the smallest of small hospitals, and 0.487
percent for the smallest of small
[[Page 47000]]
pharmacies. The table below summarizes this analysis for each of the
industry codes.
Table 5--Average Cost as Percent of Revenue
----------------------------------------------------------------------------------------------------------------
Revenue Cost as
NAICS NAICS description Firm size in Firms Revenue per firm Cost per percent of
receipts ($) ($1,000) ($) firm ($) revenue (%)
----------------------------------------------------------------------------------------------------------------
446110......... Pharmacies and <100,000 757 36,066 47,643 232 0.487
Drug Stores.
621111......... Offices of <100,000 15,275 771,280 50,493 24 0.048
Physicians
(except Mental
Health
Specialists).
621210......... Offices of <100,000 8,701 452,125 51,962 24 0.046
Dentists.
621491......... HMO Medical <100,000 24 1,266 52,750 24 0.045
Centers.
621493......... Freestanding <100,000 223 11,879 53,269 24 0.045
Ambulatory
Surgical and
Emergency
Centers.
622110......... General Medical * 100,000-499,999 14 3,812 272,286 24 0.009
and Surgical
Hospitals.
----------------------------------------------------------------------------------------------------------------
* Revenue data not available for ``<100,000.'' Examined smallest size with available revenue data.
Source: SUSB.
After normalizing the cost for revenue size of the affected firms
by dividing the total cost by the total revenue for the affected
industry, the cost as percent of revenue is much lower. As an industry,
the cost as percent of revenue is 0.0005 percent and 0.0018 percent for
prescribing firms and pharmacies, respectively. These percentages
represent all firms, including small firms. The table below summarizes
the normalized cost as percentage of revenue.
Table 6--Average Cost as Percent of Revenue, Normalized
----------------------------------------------------------------------------------------------------------------
Cost as
NAICS NAICS description Firm size in receipts Firms Revenue Cost ($) percent of
($1,000) revenue (%)
----------------------------------------------------------------------------------------------------------------
446110.......... Pharmacies and Drug All firms............. 18,852 236,277,373 4,365,034 0.0018
Stores.
621111.......... Offices of All firms............. 174,901 402,159,295 7,275,056 0.0005
Physicians (except
Mental Health
Specialists).
621210.......... Offices of Dentists All firms............. 125,151 104,740,291 ........... ...........
621491.......... HMO Medical Centers All firms............. 104 7,124,698 ........... ...........
621493.......... Freestanding All firms............. 4,121 24,084,457 ........... ...........
Ambulatory
Surgical and
Emergency Centers.
622110.......... General Medical and All firms............. 2,904 826,654,913 ........... ...........
Surgical Hospitals.
----------------------------------------------------------------------------------------------------------------
Source: SUSB.
If a patient received a partial fill pursuant to this rule, and
then returns to the pharmacy to receive another partial fill, or the
remainder of the initial prescription, the pharmacist will require some
additional time to fill the prescription. For example, if filling the
remainder of the partial fill required ten additional minutes, based on
the estimated loaded median hourly rate of $86.53 for a pharmacist,
that additional time will equate to a cost of $14.42. However, DEA
estimates these additional interactions will be minimal. As discussed
earlier in reference to the 2017 study of post-surgical patients who
were prescribed opioids, 71 percent of patients in the study did not
use the entire prescription, and on average the patients only used 33
percent of the prescribed opioids. If prescribers and patients randomly
asked for partial fills, only a small minority of patients will return
for the remainder of the prescription. However, DEA does not anticipate
the request for partial fills, at the request of the prescriber or the
patient, to be random. Rather, DEA anticipates prescribers will
exercise professional judgement and foresight in determining when a
partial fill is best suited. DEA does not believe a partial fill will
be requested by the prescriber when the prescriber believes the patient
is likely to need all of the prescribed medicine. Furthermore, while
the rule would permit patients to request partial fills, DEA believes
patients are unlikely to request a partial fill. Rather, the patient
will follow the prescriber's instructions, based on consultation
between the prescriber and the patient. Therefore, DEA believes any
increase in the number of patient-pharmacy interactions related to
patient-requested partial fills and resulting burden is de minimis.
Therefore, DEA's evaluation of economic impact by size category
indicates that the rule will not have a significant economic impact on
a substantial number of these small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined and certifies that this
action will not result in any Federal mandate that may result ``in the
expenditure by State, local, and Tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted annually
for inflation) in any 1 year.'' Therefore, neither a Small Government
Agency Plan nor any other action is required under the UMRA of 1995.
Congressional Review Act
This rule is a major rule as defined by the Congressional Review
Act, 5 U.S.C. 804. This rule will result in an annual effect on the
economy of $100,000,000 or more; DEA estimates this rule will result in
an annual cost savings of $659 million and a net cost savings of $647
million over five years. However, it will not cause a major increase in
costs or prices for consumers, individual industries, Federal, State,
or local government agencies, or geographic regions; or significant
adverse effects on competition, employment, investment, productivity,
innovation, or on the ability of United States-based enterprises to
compete with foreign-based enterprises in domestic and export markets.
DEA has submitted a copy of this final rule to both Houses of
[[Page 47001]]
Congress and to the Comptroller General.
Paperwork Reduction Act of 1995
Pursuant to section 3507(d) of the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3507(d)), DEA has identified the following collections
of information related to this rule. This rule will create additional
recordkeeping requirements for pharmacies regarding partial fills. A
person is not required to respond to a collection of information unless
it displays a valid OMB control number. Copies of existing information
collections approved by OMB may be obtained at <a href="http://www.reginfo.gov/public/do/PRAMain">http://www.reginfo.gov/public/do/PRAMain</a>.
A. Collections of Information Associated With the Rule
Title: Recordkeeping Requirements for Partial Fills of
Prescriptions for Schedule II Controlled Substances.
OMB Control Number: 1117-NEW.
DEA Form Number: N/A.
DEA is requiring pharmacies to create and maintain certain records
relating to partial fills of prescriptions for schedule II controlled
substances. When presented with a prescription for a schedule II
controlled substance, on which the prescribing practitioner has
properly specified his/her intent that the prescription be partially
filled, the pharmacist will be required to record the partial filling
in a manner similar to that required under the existing regulations
(for other circumstances).\50\ Specifically, upon each such partial
filling requested by the prescribing practitioner, the dispensing
pharmacist must make a notation of the quantity dispensed on the face
of the written prescription, in the written record of the emergency
oral prescription, or in the electronic prescription record (as is
currently required under 21 CFR 1306.13(a) when the pharmacist is
unable to supply the full quantity called for in the prescription).
Where there is an oral consultation between the pharmacist and the
prescribing practitioner after the prescription is issued, in which the
prescribing practitioner conveys his or her request for a partial
filling after issuing the prescription, the dispensing pharmacist must
notate such discussion with the following: ``Authorized by Practitioner
to Partial Fill,'' the name of the practitioner, the date and time of
the discussion, and the pharmacist's initials. For electronic
prescriptions, there needs to be an electronic prescription record and
the record needs to be permanently attached to the electronic
prescription. Also, for each such partial filling, the pharmacy will be
required to maintain a record with the date of each dispensing, the
name or initials of the individual who dispensed the substance, and all
other information required by 21 CFR 1306.22(c) for schedule III and IV
prescription refills. For electronic prescriptions specifically,
pharmacy applications will need to allow required information
pertaining to the quantity, date, and the dispenser to be linked to
each electronic controlled substance prescription record (as currently
required by 21 CFR 1311.205(b)(10)).
---------------------------------------------------------------------------
\50\ Longstanding DEA regulations, which are not be changed by
this rule, also allow the partial filling of a schedule II
prescription where the pharmacist is unable to supply the full
quantity called for in the prescription (Sec. 1306.13(a)) and for a
patient in a long-term care facility or with a terminal illness
(Sec. 1306.13(b) and (c)).
---------------------------------------------------------------------------
Upon partially filling a prescription for a schedule II controlled
substance at the request of a patient, a caregiver named in an adult
patient's medical power of attorney, or parent or legal guardian of a
minor patient, dispensing pharmacists will need to make a notation of
the following on the face of the written prescription, in the written
record of the emergency oral prescription, or in the record of the
electronic prescription: (1) ``The [patient, parent or legal guardian
of a minor patient, or caregiver of an adult patient named in a medical
power of attorney, whichever is applicable)]requested partial fill on
[date such request was made]'' and (2) the quantity dispensed. In
addition, for each such partial filling, the pharmacy will need to
maintain a record of dispensing that includes the date of each
dispensing, the name or initials of the individual who dispensed the
substance, and all other information required by 21 CFR 1306.22(c) for
schedule III and IV prescriptions. For electronic prescriptions
specifically, such required information pertaining to the quantity
dispensed, date dispensed, and the dispenser will need to be linked to
each electronic controlled substance prescription record.
DEA estimates the following number of respondents and burden
associated with this collection of information:
<bullet> Number of respondents: 68,676.
<bullet> Frequency of response: Per occurrence (264.83255 per year,
calculated).
<bullet> Number of responses: 18,187,640 per year.
<bullet> Burden per response: 0.002777778 hour (10 seconds).
<bullet> Total annual hour burden: 50,521 hours.
The activities described in this information collection are usual
and ordinary business activities and no additional cost is anticipated.
If you need additional information, please contact the Regulatory
Drafting and Policy Support Section (DPW), Diversion Control Division,
Drug Enforcement Administration; Mailing Address: 8701 Morrissette
Drive, Springfield, Virginia 22152; Telephone: (571) 776-2265.
Any additional comments on this collection of information may be
sent in writing to the Office of Information and Regulatory Affairs,
OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please
state that your comments refer to RIN 1117-AB45/Docket No. DEA-469.
Signing Authority
This document of the Drug Enforcement Administration was signed on
July 18, 2023, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
List of Subjects in 21 CFR Part 1306
Drug traffic control, Prescription drugs.
For the reasons set out above, DEA amends part 1306 as follows:
PART 1306--PRESCRIPTIONS
0
1. The authority citation for part 1306 continues to read as follows:
Authority: 21 U.S.C. 821, 823, 829a, 831, 871(b) unless
otherwise noted.
0
2. In Sec. 1306.13:
0
a. Redesignate paragraphs (b) and (c) as paragraphs (c) and (d);
0
b. Add a new paragraph (b); and
0
c. Amend newly redesignated paragraph (d)(1) by removing the cross-
reference ``Sec. 1306.13(b)'' and adding in its place the cross-
reference ``Sec. 1306.13(c)''.
The addition and reads as follows:
Sec. 1306.13 Partial filling of prescriptions.
* * * * *
(b) Partial filling of a prescription for a schedule II controlled
substance at the request of the prescribing practitioner or patient:
(1) General requirements. A prescription for a schedule II
controlled
[[Page 47002]]
substance may be partially filled if all of the following conditions
are satisfied:
(i) It is not prohibited by State law;
(ii) The prescription is written and filled in accordance with the
Act, this chapter, and State law.
(iii) The partial fill is requested by the patient, by one acting
on behalf of the patient (parent or legal guardian of a minor patient,
or caregiver of an adult patient named in a medical power of attorney),
or by the practitioner who wrote the prescription; and
(iv) The total quantity dispensed in all partial fillings does not
exceed the total quantity prescribed.
(2) Time limitations on filling the remaining portions of a
partially filled prescription for a schedule II controlled substance.
If all the conditions of paragraph (b)(1) of this section are
satisfied, and the prescription is partially filled, remaining portions
of a partially filled prescription for a schedule II controlled
substance, if filled, must be filled not later than 30 days after the
date on which the prescription is written, except that in the case of
an emergency oral prescription, as described in subsection 309(a) of
the Act (21 U.S.C. 829(a)), the remaining portions of a partially
filled prescription for a schedule II controlled substance, if filled,
must be filled not later than 72 hours after the prescription is
issued.
(3) How a practitioner may request that a prescription for a
schedule II controlled substance be partially filled. Where a
practitioner issues a prescription for a schedule II controlled
substance and wants the prescription to be partially filled, the
practitioner must specify the quantity to be dispensed in each partial
filling on the face of the written prescription, in the written record
of the emergency oral prescription, or in the record for an electronic
prescription. After consultation with a pharmacist, a practitioner may
authorize a partial fill for the prescription at a date after which the
prescription was initially issued; however, the prescription must be
filled not later than 30 days after the date on which the prescription
is written, except that in the case of an emergency oral prescription,
as described in subsection 309(a) of the Act (21 U.S.C. 829(a)), the
remaining portions of a partially filled prescription for a schedule II
controlled substance, if filled, must be filled not later than 72 hours
after the prescription is issued. The pharmacist must notate this
subsequent request in accordance with paragraph (b)(5) of this section.
All required information in this paragraph, except that of an
authorization for partial filling at a later date, must be included on
the prescription, along with the other information required by Sec.
1306.05, at the time the practitioner signs the prescription, or in the
case of an emergency oral prescription, this information must be
communicated by the prescribing practitioner to the pharmacist at the
time that the oral communication is taking place.
(4) How a patient or one acting on a patient's behalf may request
that a prescription for a schedule II controlled substance be partially
filled. A patient may request that his/her prescription for a schedule
II controlled substance be partially filled. A caregiver named in an
adult patient's medical power of attorney may request the adult
patient's prescription be partially filled. When a patient is a minor
(under age 18), a parent or legal guardian of the minor may request the
prescription be partially filled. Where a practitioner has requested
the partial filling of a prescription in accordance with paragraph
(b)(3) of this section, neither the patient, the parent or legal
guardian (in the case of a minor), nor the caregiver of an adult
patient named in a medical power of attorney may request a partial
filling in an amount greater than that specified by the practitioner. A
request by the patient, the adult patient's caregiver named in the
medical power of attorney, or the parent/legal guardian of a minor
patient may be made: in person; in writing if signed by the patient,
the adult patient's caregiver named in the medical power of attorney,
or the parent/legal guardian of a minor patient; or by a phone call to
the pharmacist from the patient, the adult patient's caregiver named in
the medical power of attorney, or the parent/legal guardian of a minor
patient.
(5) How a pharmacy must record the partial filling of a
prescription for a schedule II controlled substance. (i) Upon partially
filling a prescription at the request of the prescribing practitioner,
as requested when the prescriber issued the prescription, in accordance
with paragraph (b)(3) of this section, the pharmacist must make a
notation of the quantity dispensed on the face of the written
prescription or in the pharmacy's electronic records, in the written
record or the pharmacy's electronic records of the emergency oral
prescription, or in the record of the electronic prescription. When the
pharmacist partially fills a prescription, after the prescriber has
conveyed this request in a consultation with a pharmacist in accordance
with paragraph (b)(3), the pharmacist must note the following:
``Authorized by Practitioner to Partial Fill,'' the name of the
practitioner, the date and time of the discussion, and the pharmacist's
initials. In addition, for each such partial filling (whether requested
by the prescriber on the prescription or after consultation with the
pharmacist), the pharmacy must maintain a record of dispensing that
includes the date of each dispensing, the name or initials of the
individual who dispensed the substance, and all other information
required by 21 CFR 1306.22(c) for schedule III and IV prescription
refills. For electronic prescriptions specifically, such required
information pertaining to the quantity dispensed, date dispensed, and
the dispenser must be linked to each electronic controlled substance
prescription record.
(ii) Upon partially filling a prescription at the request of the
patient, the caregiver of an adult patient who is named in their
medical power of attorney, or a parent or legal guardian of a minor
patient, in accordance with paragraph (b)(4) of this section, the
pharmacist must make a notation of the following on the face of the
written prescription or in the pharmacy's electronic records, in the
written record or the pharmacy's electronic records of the emergency
oral prescription, or in the record of the electronic prescription: (I)
``The [patient, parent or legal guardian of a minor patient, or
caregiver of an adult patient named in a medical power of attorney]
requested partial fill on [date such request was made]'' and (II) the
quantity dispensed. In addition, for each such partial filling, the
pharmacy must maintain a record of dispensing that includes the date of
each dispensing, the name or initials of the individual who dispensed
the substance, and all other information required by 21 CFR 1306.22(c)
for schedule III and IV prescriptions. For electronic prescriptions
specifically, such required information pertaining to the quantity
dispensed, date dispensed, and the dispenser must be linked to each
electronic controlled substance prescription record.
* * * * *
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-15508 Filed 7-20-23; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on July 21, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.