20 CSR 2220-2.680 - Class R-Remote Dispensing Site Pharmacy
PURPOSE: This rule defines licensing requirements and compliance standards for Class-R Remote Dispensing Site pharmacies.
(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
2220-2.020.
(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
2220-2.010.
(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 real-time 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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