TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
Title of Regulation: 18VAC110-20. Regulations
Governing the Practice of Pharmacy (amending 18VAC110-20-275).
Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the
Code of Virginia.
Public Hearing Information:
December 3, 2019 - 9:10 a.m. - Perimeter Center, 9960
Mayland Drive, Suite 201, Board Room 4, Richmond, VA 23233
Public Comment Deadline: January 10, 2020.
Agency Contact: Caroline Juran, RPh, Executive Director,
Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463,
telephone (804) 367-4456, FAX (804) 527-4472, or email
caroline.juran@dhp.virginia.gov.
Basis: Section 54.1-2400 of the Code of Virginia
provides the Board of Pharmacy the authority to promulgate regulations to
administer the regulatory system. Section 54.1-3307 of the Code of Virginia
authorizes the board to regulate the dispensing of prescription drugs.
Purpose: The purpose of the proposed regulatory action
is to address patient safety concerns relating to brown bagging and white
bagging. Specific requirements for notification and patient information to the
receiving pharmacy or alternative delivery site of the shipment will better
ensure appropriate coordination of patient care in white bagging. Requiring
appropriate storage and security for a shipped product will protect public
health and safety. The prohibition on delivering drugs to a patient's residence
for administration, if the drug requires special storage, reconstitution, or
compounding, will protect patients and the entities responsible for the
integrity of the drug administered.
Substance: At the 2016 annual meeting of the National
Association of Boards of Pharmacy (NABP), the membership authorized a study of
"white bagging" and "brown bagging." A copy of the report
may be viewed at
https://nabp.pharmacy/wp-content/uploads/2018/04/White-Bagging-and-Brown-Bagging-Report-2018_Final.pdf.
Based on the NABP report and the expertise of pharmacist
members of the board and the pharmacy benefits manager workgroup, the board
proposes regulations:
1. Requiring the specialty pharmacy participating in white
bagging to notify the receiving pharmacy or alternative delivery site of the
shipment to ensure appropriate coordination of patient care;
2. Requiring the pharmacy to provide to the receiving pharmacy
an estimated arrival date, to provide the name of the patient to whom the drug
has been dispensed, and to provide the exact address where the product has been
shipped;
3. Requiring appropriate storage and security for a shipped
product; and
4. Prohibiting delivery to a patient's residence of any drug
that requires special storage, reconstitution, or compounding prior to
administration is intended and that will be subsequently transported by the
patient for administration.
Issues: The advantage to the public is less risk of a
drug that requires special storage or has a short shelf life will be delivered
to a pharmacy or other entity without preparations in place to receive that
drug. There are no disadvantages.
There are no advantages or disadvantages to this agency or the
Commonwealth.
Department of Planning and Budget's Economic Impact
Analysis:
Summary of the Proposed Amendments to Regulation. Under
specified circumstances, the Board of Pharmacy (Board) proposes to ease burdens
related to the delivery of prescription drugs from a pharmacy to an alternative
delivery site. The alternative delivery site may be another pharmacy, a
practitioner of the healing arts licensed to practice pharmacy or to sell
controlled substances, or an authorized person or entity holding a controlled
substances registration. The Board also proposes to prohibit delivering dispensed
drugs to a patient's residence that are intended to be subsequently transported
by the patient or patient's agent to a hospital, medical clinic, prescriber's
office, or pharmacy for administration if the drugs require special storage,
reconstitution or compounding prior to administration.
Result of Analysis. The benefits likely exceed the costs for
one or more proposed changes. For other amendments, whether the benefits exceed
the costs depend on the policy views of the observer.
Estimated Economic Impact.
Background:
In addition to direct hand delivery to a patient or patient's
agent or delivery to a patient's residence, under specified conditions a
pharmacy may deliver a dispensed prescription drug order for Schedule VI
controlled substances to another pharmacy, to a practitioner of the healing
arts licensed to practice pharmacy or to sell controlled substances, or to an
authorized person or entity holding a controlled substances registration issued
for this purpose in compliance with this section and any other applicable state
or federal law. Prescription drug orders for Schedule II through Schedule V
controlled substances may not be delivered to an alternate delivery location,
unless such delivery is authorized by federal law and regulations of the Board.
When the delivery is to another pharmacy, the two pharmacies
must have the same owner, or have a written contract or agreement specifying
the services to be provided by each pharmacy, the responsibilities of each
pharmacy (including counseling, return of any prescription medications not
delivered to the patient, etc.), and the manner in which each pharmacy will
comply with all applicable federal and state law. When the delivery is to a
practitioner of the healing arts licensed by the Board to practice pharmacy or
to sell controlled substances or another authorized person or entity holding a
controlled substances registration authorized for this purpose, there must be a
written contract or agreement between the two parties describing the procedures
for such a delivery system and the responsibilities of each party. According to
the Department of Health Professions, sometimes this is impractical or causes
delay in the delivery of a medication that a patient needs. If a specialty drug
is needed, the pharmacy benefits manager or insurer may require that the drug
be obtained from a specialty pharmacy or the pharmacy to which the prescription
is sent may not carry that drug.
Proposals:
The Board proposes to permit deliveries from a pharmacy to an
alternative delivery site without the detailed written contract or same
ownership if the alternate delivery site does not routinely receive deliveries
from the pharmacy and producing and agreeing to the contract and paperwork
details would create a delay in delivery that may result in potential patient
harm. The pharmacy would be required to notify the alternate delivery site of
the anticipated arrival date of the shipment, the exact address to where the
drug was shipped, the name of the patient for whom the drug was dispensed, and
any special storage requirements. Similar to current requirements, 1) the
pharmacy would have to provide counseling or ensure a process is in place for
the patient to receive counseling, 2) prescriptions delivered to the alternate
delivery site would have to be stored in a lockable room or lockable cabinet,
cart, or other device that cannot be easily moved and that shall be locked at
all times when not in use, and 3) the pharmacy would have to provide a
procedure for the return of any prescription drugs not delivered or
subsequently administered to the patient.
This proposed amendment may substantially reduce delays in some
patients receiving needed medications. Consequently, it may produce large
health benefits. Given the safety procedures accompanying the proposal, it
seems unlikely that there would be an increase in health risk. Thus, the
benefits very likely exceed the costs.
The Board also proposes to prohibit delivering dispensed drugs
to a patient's residence that are intended to be subsequently transported by
the patient or patient's agent to a hospital, medical clinic, prescriber's
office, or pharmacy for administration if the drugs require special storage,
reconstitution or compounding prior to administration. The proposed language
includes an exception for patients with hemophilia who may require emergent
blood factor treatment.
When drugs require special storage, reconstitution or
compounding, there is increased risk that they may become ineffective or
dangerous if not handled properly. Prohibiting the delivery of such drugs to a
patient's residence that are intended to be subsequently transported as
described above would likely reduce the occurrences where drugs that become
ineffective or dangerous due to mishandling are administered to patients. This
is beneficial. On the other hand, there may be circumstances where such
delivery is the most practical way for certain patients to quickly receive
needed treatment. The Board has recognized this by providing the exemption for
patients with hemophilia. There may be other patients for which this is true
who are not exempted by the proposal. In addition, some individuals may believe
that they should not be prevented from taking their own informed risks.
Businesses and Entities Affected. The proposed amendments
potentially affect the 1,813 pharmacies, practitioners of the healing arts
licensed to practice pharmacy or to sell controlled substances, authorized
persons or entities holding a controlled substances registration, and patients.
Localities Particularly Affected. The proposed amendments do
not disproportionately affect particular localities.
Projected Impact on Employment. The proposed amendments are
unlikely to substantially affect employment.
Effects on the Use and Value of Private Property. The proposal
to permit deliveries from a pharmacy to an alternative delivery site without a
detailed written contract may reduce costs for small firms involved. This may
modestly increase their value.
Real Estate Development Costs. The proposed amendments do not
affect real estate development costs.
Small Businesses:
Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia,
small business is defined as "a business entity, including its affiliates,
that (i) is independently owned and operated and (ii) employs fewer than 500
full-time employees or has gross annual sales of less than $6 million."
Costs and Other Effects. The proposal to permit deliveries from
a pharmacy to an alternative delivery site without a detailed written contract
may reduce costs for small firms involved.
Alternative Method that Minimizes Adverse Impact. The proposed
amendments do not adversely affect small businesses.
Adverse Impacts:
Businesses. The proposed amendments do not adversely affect
businesses.
Localities. The proposed amendments do not adversely affect
localities.
Other Entities. The proposed amendments do not adversely affect
other entities.
Agency's Response to Economic Impact Analysis: The Board
of Pharmacy concurs with the analysis of the Department of Planning and Budget.
Summary:
The proposed amendments (i) require the specialty pharmacy
participating in white bagging to notify the receiving pharmacy or alternative
delivery site of the shipment to ensure appropriate coordination of patient
care; (ii) require the pharmacy to provide to the receiving pharmacy an
estimated arrival date, to provide the name of the patient to whom the drug has
been dispensed, and to provide the exact address where the product has been
shipped; (iii) require appropriate storage and security for a shipped product;
and (iv) prohibit delivery to a patient's residence of any drug that requires
special storage, reconstitution, or compounding prior to administration is
intended and that will be subsequently transported by the patient for administration.
18VAC110-20-275. Delivery of dispensed prescriptions.
A. Pursuant to § 54.1-3420.2 B of the Code of Virginia, in
addition to direct hand delivery to a patient or patient's agent or delivery to
a patient's residence, a pharmacy may deliver a dispensed prescription drug
order for Schedule VI controlled substances to another pharmacy, to a
practitioner of the healing arts licensed to practice pharmacy or to sell
controlled substances, or to an authorized person or entity holding a
controlled substances registration issued for this purpose in compliance with
this section and any other applicable state or federal law. Prescription drug
orders for Schedule II through Schedule V controlled substances may not be
delivered to an alternate delivery location unless such delivery is authorized
by federal law and regulations of the board.
B. Delivery to another pharmacy.
1. One pharmacy may fill prescriptions and deliver the
prescriptions to a second pharmacy for patient pickup or direct delivery to the
patient provided the two pharmacies have the same owner, or have a written
contract or agreement specifying the services to be provided by each pharmacy,
the responsibilities of each pharmacy, and the manner in which each pharmacy
will comply with all applicable federal and state law.
2. Each pharmacy using such a drug delivery system shall
maintain and comply with all procedures in a current policy and procedure
manual that includes the following information:
a. A description of how each pharmacy will comply with all
applicable federal and state law;
b. The procedure for maintaining required, retrievable
dispensing records to include which pharmacy maintains the hard-copy
prescription, which pharmacy maintains the active prescription record for
refilling purposes, how each pharmacy will access prescription information
necessary to carry out its assigned responsibilities, method of recordkeeping
for identifying the pharmacist or pharmacists responsible for dispensing
the prescription and counseling the patient, and how and where this information
can be accessed upon request by the board;
c. The procedure for tracking the prescription during each
stage of the filling, dispensing, and delivery process;
d. The procedure for identifying on the prescription label all
pharmacies involved in filling and dispensing the prescription;
e. The policy and procedure for providing adequate security to
protect the confidentiality and integrity of patient information;
f. The policy and procedure for ensuring accuracy and accountability
in the delivery process;
g. The procedure and recordkeeping for returning to the
initiating pharmacy any prescriptions that are not delivered to the patient;
and
h. The procedure for informing the patient and obtaining
consent for using such a dispensing and delivery process.
3. Drugs waiting to be picked up at or delivered from the
second pharmacy shall be stored in accordance with subsection A of
18VAC110-20-200.
C. Delivery to a practitioner of the healing arts licensed by
the board to practice pharmacy or to sell controlled substances or other
authorized person or entity holding a controlled substances registration
authorized for this purpose.
1. A prescription may be delivered by a pharmacy to the office
of such a practitioner or other authorized person provided there is a written
contract or agreement between the two parties describing the procedures for
such a delivery system and the responsibilities of each party.
2. Each pharmacy using this delivery system shall maintain a
policy and procedure manual that includes the following information:
a. Procedure for tracking and
assuring security, accountability, integrity, and accuracy of delivery for the
dispensed prescription from the time it leaves the pharmacy until it is handed
to the patient or agent of the patient;
b. Procedure for providing
counseling;
c. Procedure and recordkeeping
for return of any prescription medications not delivered to the patient;
d. The procedure for assuring
confidentiality of patient information; and
e. The procedure for informing
the patient and obtaining consent for using such a delivery process.
3. Prescriptions waiting to be picked up by a patient at the
alternate site shall be stored in a lockable room or lockable cabinet, cart, or
other device that cannot be easily moved and that shall be locked at all times
when not in use. Access shall be restricted to the licensed practitioner of the
healing arts or the responsible party listed on the application for the
controlled substances registration, or either person's designee.
D. The contracts or agreements and the policy and procedure
manuals required by this section for alternate delivery shall be maintained
both at the originating pharmacy as well as the alternate delivery site.
E. A controlled substances registration as an alternate
delivery site shall only be issued to an entity without a prescriber or
pharmacist present at all times the site is open if there is a valid patient
health or safety reason not to deliver dispensed prescriptions directly to the
patient and if compliance with all requirements for security, policies, and
procedures can be reasonably assured.
F. The pharmacy and alternate delivery site shall be
exempt from compliance with subsections B through E of this section if (i) the
alternate delivery site is a pharmacy, a practitioner of healing arts licensed
by the board to practice pharmacy or sell controlled substances, or other
entity holding a controlled substances registration for the purpose of
delivering controlled substances; (ii) the alternate delivery site does not
routinely receive deliveries from the pharmacy; and (iii) compliance with
subsections B through E of this section would create a delay in delivery that
may result in potential patient harm. However, the pharmacy and alternate
delivery site shall comply with following requirements:
1. To ensure appropriate coordination of patient care, the
pharmacy shall notify the alternate delivery site of the anticipated arrival
date of the shipment, the exact address to where the drug was shipped, the name
of the patient for whom the drug was dispensed, and any special storage
requirements.
2. The pharmacy shall provide counseling or ensure a
process is in place for the patient to receive counseling.
3. Prescriptions delivered to the alternate delivery site
shall be stored in a lockable room or lockable cabinet, cart, or other device
that cannot be easily moved and that shall be locked at all times when not in
use. Access shall be restricted to the licensed prescriber, pharmacist, or
either person's designee.
4. The pharmacy shall provide a procedure for the return of
any prescription drugs not delivered or subsequently administered to the
patient.
G. A pharmacy shall not deliver dispensed drugs to a
patient's residence that are intended to be subsequently transported by the
patient or patient's agent to a hospital, medical clinic, prescriber's office,
or pharmacy for administration and that require special storage, reconstitution
or compounding prior to administration. An exception to this requirement may be
made for patients with hemophilia who may require emergent blood factor
treatment.
VA.R. Doc. No. R18-5376; Filed October 23, 2019, 11:42 a.m.