20 CSR 2220-2.680 - Class R-Remote Dispensing Site Pharmacy
(1)
Definitions.
(A) "Community Mental Health
Center"-A community mental health center as defined by
42 CFR section
410.2, section
205.975, RSMo, or the Missouri
Department of Mental Health.
(B)
"Federally qualified health center"-A federally qualified health center as
defined by 42 U.S.C. section
1396d(l)(2)(B), as
amended.
(C) "Intern Pharmacist"-An
individual who holds a current and active Missouri intern pharmacist license
and has completed employer approved training in the activities to be performed
at the Class R pharmacy and has an initial and annual documented assessment of
competency.
(D) "Outpatient
Clinic"-A facility where healthcare services are provided by a licensed
healthcare provider on the facility's premises to patients who are not
hospitalized or admitted to the outpatient clinic for greater than twenty-three
(23) hours.
(E) "Qualified Pharmacy
Technician"-A currently registered Missouri pharmacy technician who-
1. Holds an active pharmacy technician
certification issued by a certification entity accredited by the National
Commission for Certifying Agencies;
2. Has completed employer approved training
in the activities to be performed at the Class R pharmacy and has an initial
and annual documented assessment of competency; and
3. Has assisted in the practice of pharmacy
as a registered pharmacy technician in the state of Missouri for a minimum of
one (1) year.
(F) "Remote
Dispensing Site Pharmacy"-Any location in this state where the practice of
pharmacy occurs that is staffed by one (1) or more qualified pharmacy
technicians or intern pharmacists whose activities are supervised by a
pharmacist at a supervising pharmacy that is under common ownership through a
continuous real-time audio and video link. A remote dispensing site pharmacy
does not include a dispensing prescriber's office or an automated
device.
(G) "Retail Pharmacy"-A
pharmacy licensed by the board that is open to, and offers pharmacy services
to, the general public.
(H) "Rural
Health Clinic"-A rural health clinic as defined by the federal Rural Health
Clinic Services Act, PL. 95-210, as amended.
(I) "Supervising pharmacy"-A Missouri
licensed pharmacy located in this state or approved by the board that oversees
the dispensing activities of a Class R pharmacy.
(2) A Class R pharmacy permit is required for
any Missouri location operating, or offering to operate, as a remote dispensing
site pharmacy in Missouri. Applications for a Class R permit must be submitted
on a form approved by the board with the pharmacy permit fee, in accordance
with 20 CSR 22202.020.
(A) Class R pharmacy
permits expire and must be renewed, as provided by Chapter 338, RSMo and 20 CSR
2220-2 for pharmacy permits. Renewal applications must be submitted on a form
approved by the board with the applicable renewal fee.
(B) Class R pharmacies must be located at
least ten (10) miles away from an existing retail pharmacy unless the Class R
pharmacy is part of a community mental health center, federally qualified
health center, rural health clinic, or outpatient clinic setting. Requests to
waive the mileage requirement may be submitted to the board in writing along
with documentation demonstrating how the proposed remote dispensing site
pharmacy will promote public health. The board will consider the following
factors when determining whether to grant a waiver request:
1. The availability of pharmacy services in
the proposed pharmacy area;
2. The
nature of proposed Class R pharmacy services;
3. Benefits or risks to patient
care;
4. The applicant's and
supervising pharmacy's experience and compliance history; and
5. Any other factor that may benefit or
adversely impact public health.
(C) Class R pharmacies shall be authorized to
provide Class A, Class B, and Class C pharmacy services with a Class R permit.
Class R pharmacies must apply for and hold the applicable pharmacy permit
classification identified in section
338.220, RSMo, for any
additional pharmacy services provided by the pharmacy. A Class J Shared
services permit is not required for Class R pharmacies engaged in shared
pharmacy services with the supervising pharmacy. If the Class R pharmacy is
engaged in Class J shared services with another pharmacy, or has an arrangement
to provide or receive Class J shared services with another pharmacy, the
supervising pharmacy, the remote dispensing site, and all involved pharmacies
must have a Class J shared services permit and comply with
20 CSR
2220-2.650.
(D) By the tenth day following each calendar
quarter, Class R pharmacies must calculate the average number of prescriptions
dispensed by the pharmacy per day during the previous calendar quarter,
excluding immunizations given by protocol (e.g., January 10, April 10, July 10,
October 10).
1. If the average number of
prescriptions or medication orders dispensed by the pharmacy during the
previous quarter exceeds one hundred fifty (150) prescriptions/medication
orders per day, excluding immunizations given by protocol, the pharmacy must
apply for a change of classification to add a Class A, B, or C permit
classification within ten (10) days of discovery. Change of classification
requests must be submitted on a form approved by the board with the applicable
fee. Class R operations must cease once a Class A, B, or C permit is issued by
the board.
2. Class R operations may
resume if the daily average number of prescriptions dispensed by the pharmacy
does not exceed one hundred fifty (150) prescriptions/medications orders during
a calendar quarter (January 1-March 31, April 1-June 30, July 1-September 30,
or October 1-December 31). The pharmacy's Class A, B, or C pharmacy
classification must be surrendered to the board within five (5) days of
resuming Class R operations.
(3) Supervising Pharmacies. Class R
pharmacies must be under the supervision of a supervising pharmacy, as required
by section 338.215, RSMo. The supervising
pharmacy must ensure the Class R pharmacy is properly and safely operated in
compliance with applicable state and federal law. Effective policies and
procedures must be in place to ensure appropriate oversight of a Class R
pharmacy at all times.
(A) The supervising
pharmacy and Class R pharmacy must manually or electronically maintain a
current and accurate written policy and procedure manual that complies with
section 338.215, RSMo.
(B) The supervising pharmacy and Class R
pharmacy must share a common database or have access to each other's
prescription record-keeping system. The common database or shared system must
allow real-time, online access to the patient's complete profile for both the
supervising pharmacy and the Class R pharmacy.
(C) Supervising pharmacies must be located in
Missouri and within fifty (50) miles of the supervised Class R pharmacy site,
unless otherwise approved by the board. Requests to waive the location and
mileage requirements must be submitted to the board in writing along with proof
the Class R pharmacy will be sufficiently supported by the supervising pharmacy
and that necessary personnel or supplies can be delivered to the Class R
pharmacy within a reasonable period of time of an identifiable need. The board
will also consider the factors identified in subsection (2)(B) of this rule
when reviewing a waiver request.
(D)
A Class R pharmacy must immediately cease operations if the supervising
pharmacy and Class R pharmacy are no longer under common ownership, the
supervising pharmacy is no longer eligible to supervise the Class R pharmacy,
or the supervising pharmacy's Missouri pharmacy permit is not current and
active. Class R operations may resume once the supervising pharmacy's permit
returns to active or eligible status or common ownership is
reestablished.
(4) Class R
Standards of Operation. Except as otherwise authorized by law, Class R
pharmacies must comply with all laws and regulations applicable to the pharmacy
services provided by the Class R pharmacy, including, 20 CSR 22202.010.
(A) Class R pharmacies must be staffed by a
current and active Missouri licensed pharmacist at least eight (8) hours a
month. At a minimum, the pharmacist-in-charge (PIC) of the Class R pharmacy
must visit the remote dispensing site weekly during the first month of
operation to verify compliance and monthly thereafter. The date of the monthly
PIC compliance visit must be documented in the pharmacy's records.
(B) Class R pharmacies must maintain a
perpetual inventory for all controlled substances that is reconciled twice per
month. The PIC must review the reconciliation for accuracy/ discrepancies
during the compliance visits required by subsection (4)(A).
(C) A prominent sign must be posted at the
Class R pharmacy notifying patients that the remote dispensing site is
supervised by the supervising pharmacy along with the supervising pharmacy's
name, address, and telephone number.
(D) Intern pharmacists and qualified pharmacy
technicians activities must be supervised by a Missouri-licensed pharmacist
present at the Class R pharmacy or remotely supervised by a Missouri-licensed
pharmacist located at the supervising pharmacy using technology that provides a
continuous realtime audio and video link. The required technology must allow
the supervising pharmacist to provide the personal assistance, direction, and
approval needed to verify and ensure remote tasks are safely and properly
performed. The supervising pharmacist must be employed by the supervising
pharmacy, as required by section
338.215, RSMo, and must be
competent to perform the services being supervised. A pharmacist cannot
supervise more than two (2) Class R pharmacies at the same time.
(E) A Class R pharmacy may not be operated if
the required supervision technology is unavailable or not in working order
unless a pharmacist is onsite. The no pharmacist on duty sign required by
20 CSR
2220-2.010 must be posted in the event of a technology
or system malfunction that requires the Class R pharmacy to cease
operations.
(5) Medication
Dispensing. Prescriptions/Medication orders may be prepared, dispensed, or
compounded at a Class R pharmacy, as authorized by section
338.215, RSMo, and the rules of
the board.
(A) The final contents and label of
a prescription/medication order must be verified by a Missouri licensed
pharmacist at the Class R pharmacy, or remotely verified by a Missouri licensed
pharmacist located at the supervising pharmacy through the use of technology
that includes bar coding and visual review of the medication contents and
affixed label via remote video. The verifying pharmacist must be employed by
the supervising pharmacy, as required by section
338.215, RSMo.
(B) Patient counseling must be provided for
all new and refill prescriptions, unless refused by the patient. The required
patient counseling must be provided by a Missouri licensed pharmacist at the
Class R pharmacy or remotely provided by a Missouri licensed pharmacist at the
supervising pharmacy via a HIPAA-compliant continuous real-time video and audio
link, as authorized by section
338.215, RSMo. Medication may
not be dispensed without a pharmacist physically present at the Class R
pharmacy if the required counseling technology is not available or in working
order. Remote patient counseling via technology may not be delegated to an
intern pharmacist.
(C) Policies and
procedures must be established to ensure appropriate pharmacist review of
verbal prescription orders received by an intern pharmacist or qualified
pharmacy technician at a Class R pharmacy when a pharmacist is not
present.
(6) Adequate
security and supervision must be maintained at all times to prevent
unauthorized access to a Class R pharmacy and prevent medication theft and
diversion.
(A) An alarm mechanism must be
maintained that alerts the supervising pharmacy or the Class R
pharmacist-in-charge in the event of unauthorized access to the remote
dispensing site. Unauthorized access to a Class R pharmacy must be documented
and reported to the board in writing within seven (7) days of
discovery.
(B) Confidential records
must be securely maintained to prevent unauthorized access and ensure secure
data access and storage at all times.
(7) Record-Keeping.
(A) Except as otherwise provided by law,
Class R pharmacies shall comply with all applicable record-keeping and
documentation requirements of Chapter 338, RSMo, and the board's
rules.
(B) Class R pharmacies must
also maintain documentation of-
1. The number
of prescriptions dispensed by the Class R pharmacy each calendar quarter;
and
2. Proof that qualified pharmacy
technicians and intern pharmacists assisting at a Class R pharmacy have
completed the experience, training, and competency assessment required by this
rule.
(C) Records required
by this rule must be manually or electronically maintained for two (2) years at
the Class R pharmacy, or at the supervising pharmacy if the Class R pharmacy is
no longer operating, and must be readily retrievable on request of the board or
the board's authorized designee.
Notes
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