20 CSR 2220-2.910 - Class O: Automated Dispensing Systems (Ambulatory Care)
PURPOSE: This rule establishes licensing standards and requirements for Class O: Automated Dispensing Systems (Ambulatory Care).
(1) Definitions.
(A) "Ambulatory prescription dispensing
system"-A Class O automated dispensing system (Class O ADS) used to process,
verify, fill, label, and dispense a completed prescription/medication order for
patient retrieval from the system using an electronic verification
system.
(B) "Class O automated
dispensing system"- A pharmacy license classification which allows the use of
an ambulatory prescription dispensing system or a prescription pick-up system
as defined by this rule at a specific location. A Class O ADS does not include
an automated system used for compounding medication, a Class N automated
dispensing system, or an automated filling system governed by
20 CSR
2220-2.950.
(C) "Electronic verification system"-An
electronic verification, bar code verification, weight verification, radio
frequency identification (RFID), or similar electronic process or system
process used to verify and ensure medication/prescriptions have been properly
stocked, restocked, loaded, filled, dispensed, or labeled.
(D) "Prescription pick-up system"-A Class O
ADS that allows a patient to obtain a filled, labeled, and pharmacist-verified
prescription/medication order placed in the system by or on behalf of a
Missouri-licensed pharmacy for patient retrieval. A prescription pick-up system
does not include a vacuum tube drug delivery system identified in
20 CSR
2220-2.800.
(E) "Supervising pharmacist"-A
Missouri-licensed pharmacist designated to supervise a Class O ADS while the
system is in operation.
(2) Licensing. Applicants for a Class O ADS
pharmacy permit classification must file an application on a form approved by
the board and pay the applicable fee. A pharmacy Change of Classification
application is required for currently licensed Missouri pharmacies opting to
add a Class O ADS classification to their existing Missouri pharmacy permit.
Application fees to add or obtain a Class O ADS pharmacy permit shall be waived
for Class N ADS permit holders licensed on the effective date of this rule for
a period of six (6) months from this rule's effective date.
(A) A Class O ADS permit may be used to
operate all Class O ADSs located at the address designated on the permit. A
Class O ADS may only be used by the permit holder, and may not be used to
dispense prescriptions/medication orders for multiple pharmacies.
(B) The appropriate pharmacy permit
classification is required for any pharmacy activities under the board's
jurisdiction that occur at the Class O ADS site other than operating the Class
O ADS. Class O ADS pharmacies must comply with all requirements applicable to
any additional pharmacy permit classifications held by the pharmacy, including
but not limited to all applicable security and staff supervision requirements.
A Class J pharmacy permit is required for shared service activities, as
provided in 20 CSR 2220-2.650.
(C) To be eligible for licensure, a Class O
ADS must be located within the permitted address of a Missouri-licensed
pharmacy where pharmacy services other than Class J Shared services, Class I
Consultant services, or Class O ADS services are provided, or at an indoor
location where health care services are regularly provided by a licensed health
care provider at the same location. A Class O ADS must be located at an address
recognized by the United States Postal Service and may not be located outside
of a physical structure.
(D)
Applicants may petition the board in writing to approve a Class O ADS at an
alternative location to increase patient access to medication in an area where
access to an ambulatory/ community pharmacy is limited. Petition requests must
include documentation or evidence demonstrating how the proposed Class O ADS
location will expand patient access to medication and promote public health.
The board will consider the following factors when determining petition
requests:
1. The availability of pharmacy
services in the proposed Class O ADS pharmacy area;
2. Benefits or risks to patient
care;
3. Policies/procedures for
ensuring adequate security;
4. The
permit holder's ability to promptly access the Class O ADS in the event of an
emergency, which shall be no more than thirty (30) minutes;
5. The applicant's experience and compliance
history; and
6. Any other factor
that may benefit or adversely impact public
health.
(3)
System requirements. A Class O ADS must be maintained in good working order and
in a clean and sanitary manner. If applicable, a Class O ADS must be cleaned
and disinfected on a regular basis using appropriate materials and agents.
(A) A sign must be conspicuously posted or
electronically displayed on the Class O ADS that clearly identifies the permit
holder's name, address, the system's hours of operation, and a telephone number
for contacting the pharmacy during operational hours.
(B) A Missouri-licensed pharmacist must be
capable of being physically present at the approved Class O ADS location within
thirty (30) minutes in the event of an emergency or other system
malfunction.
(C) A video
surveillance system must be in place that allows the pharmacy to physically
view the Class O ADS and the Class O ADS site at all times. A video
surveillance system is not required if a pharmacist is present on-site and able
to view the Class O ADS at all times the system is accessible to the
public.
(D) Medication must be
stored and maintained in a thermostatically controlled area within temperature
and humidity requirements as provided in the Food and Drug Administration
approved drug product labeling or the United States Pharmacopeia
(USP).
(E) At a minimum,
temperatures in drug storage areas of the Class O ADS must be recorded and
reviewed daily. Alternatively, a continuous temperature monitoring system may
be used to comply with this subsection, if the system maintains ongoing
documentation of temperature recordings that promptly alerts pharmacy staff
when temperatures are outside of the required range and provides the amount of
variance.
(F) The Class O ADS
system must use an electronic verification system to electronically verify and
ensure prescriptions/ medication orders are properly dispensed to the correct
patient. The electronic verification system(s) must be validated by a properly
qualified board licensee or appropriately supervised board registrant
designated by the pharmacy to ensure the system is functioning properly prior
to first use and prior to restarting the system after an unanticipated system
shutdown or interruption. Additional validation must occur if any modification
to the Class O ADS occurs that changes or alters the dispensing or electronic
verification process. Validation dates and results must be documented in
writing and readily retrievable.
(G) The Class O ADS permit holder must
regularly review system operations to ensure proper functioning. At a minimum,
a Missouri-licensed pharmacist must visit and review Class O ADS operations
weekly during the first month of system operations and monthly thereafter. The
dates of the required weekly and monthly visits/reviews and the identity of the
designated pharmacist must be documented and readily retrievable at the request
of the board or the board's authorized designee. The permit holder shall remain
responsible for Class O ADS services and ensuring proper functioning.
(H) An ongoing and documented quality
assurance program must be established to monitor the performance of the Class O
ADS. The quality assurance program must include procedures for handling and
reporting dispensing errors, system malfunctions, and other compliance
concerns.
(I) Notification of any
dispensing error involving a Class O ADS that is dispensed to the patient must
be submitted electronically or in writing to the board within ten (10) days of
discovery. The required notification must include the date of the incident,
patient name, description of the error, the applicable prescription/medication
order number or unique identifier, and any corrective action
taken.
(4) Standards of
operation. A Class O ADS must be safely and properly operated at all times in
compliance with applicable state and federal laws, including but not limited to
all applicable controlled substance laws. Medication must be accurately
dispensed and labeled.
(A) Medication may only
be dispensed by a Class O ADS pursuant to a valid patient-specific prescription
or medication order. A Class O ADS may not be used to dispense
prescriptions/medication for multiple pharmacies.
(B) The Class O ADS must be supervised at all
times it is in operation by a Missouri-licensed pharmacist who is either
physically present at the Class O ADS site or who is supervising via an
electronic system that allows the pharmacist to adequately view the Class O ADS
and supervise all Class O ADS activities. The required pharmacist supervision
may not be delegated to an intern pharmacist.
1. The supervising pharmacist must maintain
full operational control over the Class O ADS whenever the Class O ADS is in
operation, and must be able to terminate or suspend Class O ADS operations when
deemed necessary or appropriate.
2.
The required electronic system must provide a continuous real-time video link
to allow the supervising pharmacist to see the entire Class O ADS site. A two-
(2-) way communication mechanism must also be available that allows
communication between the supervising pharmacist and any technicians or intern
pharmacists present on-site. Medication may not be dispensed and the Class O
ADS may not be operated if the required video link and audio communication are
not fully functioning.
3. A
supervising pharmacist may not supervise more than two (2) Class O ADSs at a
time. The identity of the supervising pharmacist must be documented and
maintained in the supervising pharmacy's records. Licensees may request a
waiver of the supervision limit. The board will consider the factors in
subsection (2)(D) when determining waiver requests.
(C) For Class O ADS prescription pick-up
systems, only filled and labeled prescriptions that have been verified by a
pharmacist may be loaded in or dispensed from the Class O ADS prescription
pick-up system, except as otherwise authorized by law. The entire dispensing
process must be fully automated after the prescription/medication order is
loaded into the Class O prescription pick-up system. No manual manipulation of
the prescription/medication order or the affixed label may occur after the
prescription/medication order is stocked, restocked, or loaded in the Class O
ADS prescription pick-up system.
(D) For Class O ADS ambulatory prescription
dispensing systems, the entire prescription/medication order filling,
dispensing, and labeling process must be automated and the required
prescription/medication label must be affixed by the Class O ADS ambulatory
prescription dispensing system prior to dispensing from the Class O ADS
ambulatory prescription dispensing system. No manual manipulation of the
prescription/medication order or the affixed label may occur after the
automated filling process is initiated.
(E) Medication may not be dispensed via a
Class O ADS if the patient or the patient's authorized designee requests not to
use the Class O ADS.
(5)
Patient counseling. An offer to counsel must be made to the patient or the
patient's authorized representative prior to a prescription or medication order
being dispensed from a Class O ADS, except as otherwise required by law for
Class R remote dispensing site pharmacies. The offer to counsel may be made
verbally by authorized pharmacy staff or made electronically via the Class O
ADS.
(A) Adequate space and equipment must be
available to confidentially counsel patients. Live, real-time patient
counseling must be provided if counseling is requested by the patient or
otherwise required. If a pharmacist is not present on-site, two- (2-) way video
and audio technology must be available that allows the pharmacist and patient
to both view and communicate with each other. Medication may not be dispensed
if the required video and audio technology is not fully functioning.
(B) Video monitors/screens used for patient
counseling or communication must be a minimum of twelve inch (12") wide
diagonally. Backlighting or other factors that may inhibit video performance
must be taken into account when using video technology to counsel/communicate
with patients.
(C) A sign must be
conspicuously posted or continuously displayed electronically on the Class O
ADS informing patients that a pharmacist will provide counseling either
in-person or via the video/audio system on request. The sign must include clear
instructions for requesting counseling and must be easily viewed and readable
by the public.
(6)
Stocking/restocking. Medication must be securely stocked, loaded, and reloaded
in a Class O ADS in a manner that protects against theft or diversion, and in
compliance with 20 CSR 2220-2.010.
(A) Only board licensees or registrants may
stock, load, or restock a Class O ADS, as authorized by the supervising
pharmacy's policies and procedures.
(B) For Class O ADS prescription pick-up
systems, a pharmacist must physically verify that prescriptions/medication
orders have been properly loaded into the Class O ADS prescription pick-up
system. The identity of the verifying pharmacist must be documented and
maintained in the pharmacy's records. Alternatively, an electronic verification
system may be used to verify that prescriptions/medication orders have been
properly loaded into the Class O ADS prescription pick-up system, if no manual
intervention with the prescription/ medication order occurs after the
electronic verification is completed. If authorized by a pharmacist, intern
pharmacists or pharmacy technicians may load a Class O ADS prescription pick-up
system without a pharmacist present or additional pharmacist verification if-
1. An electronic verification system is used
to verify the prescription/medication order has been properly loaded into the
ADS system;
2. No manual
intervention with the prescription/medication order occurs after the electronic
verification required by this subsection, other than removing the prescription/
medication order by authorized pharmacy staff for return/ destruction;
and
3. The electronic verification
system has been validated and revalidated as required by subsection (3)(F).
Validation dates and results must be documented in writing and readily
retrievable.
(C) For
Class O ADS ambulatory prescription dispensing systems, an electronic
verification system must be used to verify that medication or medication
containers have been properly stocked, restocked, and loaded into the Class O
ADS ambulatory prescription dispensing system. If authorized by a pharmacist,
intern pharmacists or pharmacy technicians may stock, restock, or load
manufacturer unit of use packages and repacked containers previously verified
by a pharmacist into a Class O ADS ambulatory prescription dispensing system
without a pharmacist present or additional pharmacist verification if-
1. An electronic verification system is used
to verify the medication has been correctly stocked, restocked, or
loaded;
2. No manual intervention
with the manufacturer unit of use package or repacked container occurs after
the required electronic verification required by this subsection occurs, other
than removing the manufacturer unit of use package or repacked container by
authorized pharmacy staff for return/ destruction; and
3. The electronic verification system has
been validated and revalidated as required by subsection (3)(F). Validation
dates and results must be documented in writing and readily
retrievable.
(D)
Return-to-stock medication may be returned and reused as authorized by
20 CSR
2220-3.040 or
20 CSR
2220-2.145 governing multi-med dispensing. No
medication shall be returned directly to a Class O ADS for reissue or reuse by
a person not licensed or registered by the Board of Pharmacy.
(E) The following documentation must be
maintained and readily retrievable:
1. The
date and time prescriptions/medication orders are stocked, loaded, restocked,
and removed from the Class O ADS system;
2. The date and time medications are stocked,
loaded, restocked, and removed from the Class O ADS system;
3. The identity of individuals stocking,
loading, restocking, or removing prescriptions/medication orders and medication
in the system; and
4. For Class O
ADS ambulatory prescription dispensing systems, the identity of the pharmacist
responsible for verifying the contents of any manufacturer unit of use packages
and repacked containers stocked, restocked, or loaded into the Class O ADS
ambulatory prescription dispensing system by an intern pharmacist or pharmacy
technician without a pharmacist present.
(7) Security. Adequate security and
supervision must be maintained to prevent medication theft and diversion and
unauthorized access to or use of the Class O ADS. Class O ADS permit holders
must comply with all security provisions of this rule and
20 CSR
2220-2.010. Confidential records must be securely
maintained to prevent unauthorized access to, and unauthorized storage/transfer
of, confidential information.
(A) A Class O
ADS must be securely placed, locked, and maintained at the address licensed by
the board in a manner that prevents theft, diversion, or unauthorized access,
or medication removal. Authorized access to the Class O ADS must be defined in
the permit holder's policy and procedures.
(B) In addition to the requirements of
section (8), written policies and procedures must be in place to immediately
access, secure, remove, and store medication in the event of an emergency or
security breach.
(C) The Class O
ADS must have an alarm mechanism that promptly alerts a designated member(s) of
the pharmacy's staff in the event of a security breach or unauthorized access
to the Class O ADS. For Class O ADSs located outside of a Missouri-licensed
pharmacy, the alarm must also alert local law enforcement in the event of a
security breach or unauthorized access to the Class O ADS, if available.
Additionally, a board licensee or registrant located in Missouri must have the
authority to access and suspend operations of the Class O ADS if
necessary.
(D) Confirmed or
suspected security breaches of the Class O ADS must be immediately
investigated. If confirmed, use/ operation of the Class O ADS must immediately
cease until the security breach has been rectified and proper security is
restored. All security breaches of the Class O ADS must be documented and
reported to the board in writing within three (3) business days of
discovery.
(E) Any confirmed or
suspected medication diversion/theft must be immediately investigated.
Medication diversion/theft must be reported to the board in writing within
three (3) business days of discovery.
(F) A perpetual inventory must be maintained
for each Class O ambulatory prescription dispensing system stocking controlled
substances that is reconciled by pharmacy staff on a monthly
basis.
(8) Policies and
procedures. Class O permit holders must maintain current and accurate written
policies and procedures governing all aspects of Class O ADS activities,
including but not limited to-
(A) Staff
education and training;
(B)
Maintaining the Class O ADS and the accompanying electronic verification
process in good working order;
(C)
Maintaining and protecting system data and confidential information;
(D) Granting, restricting, or terminating
Class O ADS system access;
(E)
Filling, stocking, restocking, and loading the Class O ADS;
(F) Removing expired, adulterated,
misbranded, or recalled medication;
(G) Temperature monitoring and
documentation;
(H) Prescription
processing, verification, and recordkeeping;
(I) Patient counseling;
(J) Ensuring cleanliness and sanitary
operation of the Class O ADS and preventing cross-contamination of cells,
cartridges, containers, cassettes, or packages;
(K) Emergency response procedures, including
but not limited to addressing power outages and terminating and restarting
Class O ADS operations;
(L)
Monitoring medication inventory to prevent diversion, theft, or loss, including
an escalation policy/procedure for addressing inventory
discrepancies;
(M) Security
requirements, including policies/procedures for authorizing Class O ADS access
and terminating Class O ADS operations in the event of a confirmed or suspected
security breach, inventory discrepancy, suspected loss/diversion, loss of
patient confidential information, and unauthorized access to the Class O
ADS;
(N) Receiving, handling,
documenting, and investigating alarm notifications/alerts in the event of a
security breach of the Class O ADS;
(O) Conducting routine and preventive system
validation and maintenance of the Class O ADS;
(P) Quality assurance;
(Q) Handling, investigating, and reporting
dispensing errors;
(R)
Recordkeeping; and
(S) Data
retention and retrieval.
(9) Records.
(A) Class O permit holders must maintain
readily retrievable records of all Class O ADS transactions, including but not
limited to all prescriptions and medication orders processed and/ or dispensed
by the Class O ADS and records of all medication stocked in or removed from the
Class O ADS.
(B) Prescriptions and
medication orders dispensed from a Class O ADS must be separately identifiable
in the pharmacy's prescription records and individually retrievable from other
prescriptions/medication orders maintained by the pharmacy. This requirement
also applies to any Class J pharmacy dispensing prescriptions via a Class O
ADS.
(C) Except as otherwise
provided by this rule or other applicable law, all records required by this
rule must be maintained for a minimum of two (2) years and readily retrievable
on request of the board or a board-authorized designee. Records maintained at a
pharmacy must be produced immediately or within two (2) hours of a request from
the board or the board's authorized designee, or by making a computer terminal
available to the inspector for immediate use to review the records requested.
Records not maintained at a pharmacy must be produced within three (3) business
days of a board request.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
PURPOSE: This rule establishes licensing standards and requirements for Class O: Automated Dispensing Systems (Ambulatory Care).
(1) Definitions.
(A) "Ambulatory prescription dispensing system"-A Class O automated dispensing system (Class O ADS) used to process, verify, fill, label, and dispense a completed prescription/medication order for patient retrieval from the system using an electronic verification system.
(B) "Class O automated dispensing system"- A pharmacy license classification which allows the use of an ambulatory prescription dispensing system or a prescription pick-up system as defined by this rule at a specific location. A Class O ADS does not include an automated system used for compounding medication, a Class N automated dispensing system, or an automated filling system governed by 20 CSR 2220-2.950.
(C) "Electronic verification system"-An electronic verification, bar code verification, weight verification, radio frequency identification (RFID), or similar electronic process or system process used to verify and ensure medication/prescriptions have been properly stocked, restocked, loaded, filled, dispensed, or labeled.
(D) "Prescription pick-up system"-A Class O ADS that allows a patient to obtain a filled, labeled, and pharmacist-verified prescription/medication order placed in the system by or on behalf of a Missouri-licensed pharmacy for patient retrieval. A prescription pick-up system does not include a vacuum tube drug delivery system identified in 20 CSR 2220-2.800.
(E) "Supervising pharmacist"-A Missouri-licensed pharmacist designated to supervise a Class O ADS while the system is in operation.
(2) Licensing. Applicants for a Class O ADS pharmacy permit classification must file an application on a form approved by the board and pay the applicable fee. A pharmacy Change of Classification application is required for currently licensed Missouri pharmacies opting to add a Class O ADS classification to their existing Missouri pharmacy permit. Application fees to add or obtain a Class O ADS pharmacy permit shall be waived for Class N ADS permit holders licensed on the effective date of this rule for a period of six (6) months from this rule's effective date.
(A) A Class O ADS permit may be used to operate all Class O ADSs located at the address designated on the permit. A Class O ADS may only be used by the permit holder, and may not be used to dispense prescriptions/medication orders for multiple pharmacies.
(B) The appropriate pharmacy permit classification is required for any pharmacy activities under the board's jurisdiction that occur at the Class O ADS site other than operating the Class O ADS. Class O ADS pharmacies must comply with all requirements applicable to any additional pharmacy permit classifications held by the pharmacy, including but not limited to all applicable security and staff supervision requirements. A Class J pharmacy permit is required for shared service activities, as provided in 20 CSR 2220-2.650.
(C) To be eligible for licensure, a Class O ADS must be located within the permitted address of a Missouri-licensed pharmacy where pharmacy services other than Class J Shared services, Class I Consultant services, or Class O ADS services are provided, or at an indoor location where health care services are regularly provided by a licensed health care provider at the same location. A Class O ADS must be located at an address recognized by the United States Postal Service and may not be located outside of a physical structure.
(D) Applicants may petition the board in writing to approve a Class O ADS at an alternative location to increase patient access to medication in an area where access to an ambulatory/ community pharmacy is limited. Petition requests must include documentation or evidence demonstrating how the proposed Class O ADS location will expand patient access to medication and promote public health. The board will consider the following factors when determining petition requests:
1. The availability of pharmacy services in the proposed Class O ADS pharmacy area;
2. Benefits or risks to patient care;
3. Policies/procedures for ensuring adequate security;
4. The permit holder's ability to promptly access the Class O ADS in the event of an emergency, which shall be no more than thirty (30) minutes;
5. The applicant's experience and compliance history; and
6. Any other factor that may benefit or adversely impact public health.
(3) System requirements. A Class O ADS must be maintained in good working order and in a clean and sanitary manner. If applicable, a Class O ADS must be cleaned and disinfected on a regular basis using appropriate materials and agents.
(A) A sign must be conspicuously posted or electronically displayed on the Class O ADS that clearly identifies the permit holder's name, address, the system's hours of operation, and a telephone number for contacting the pharmacy during operational hours.
(B) A Missouri-licensed pharmacist must be capable of being physically present at the approved Class O ADS location within thirty (30) minutes in the event of an emergency or other system malfunction.
(C) A video surveillance system must be in place that allows the pharmacy to physically view the Class O ADS and the Class O ADS site at all times. A video surveillance system is not required if a pharmacist is present on-site and able to view the Class O ADS at all times the system is accessible to the public.
(D) Medication must be stored and maintained in a thermostatically controlled area within temperature and humidity requirements as provided in the Food and Drug Administration approved drug product labeling or the United States Pharmacopeia (USP).
(E) At a minimum, temperatures in drug storage areas of the Class O ADS must be recorded and reviewed daily. Alternatively, a continuous temperature monitoring system may be used to comply with this subsection, if the system maintains ongoing documentation of temperature recordings that promptly alerts pharmacy staff when temperatures are outside of the required range and provides the amount of variance.
(F) The Class O ADS system must use an electronic verification system to electronically verify and ensure prescriptions/ medication orders are properly dispensed to the correct patient. The electronic verification system(s) must be validated by a properly qualified board licensee or appropriately supervised board registrant designated by the pharmacy to ensure the system is functioning properly prior to first use and prior to restarting the system after an unanticipated system shutdown or interruption. Additional validation must occur if any modification to the Class O ADS occurs that changes or alters the dispensing or electronic verification process. Validation dates and results must be documented in writing and readily retrievable.
(G) The Class O ADS permit holder must regularly review system operations to ensure proper functioning. At a minimum, a Missouri-licensed pharmacist must visit and review Class O ADS operations weekly during the first month of system operations and monthly thereafter. The dates of the required weekly and monthly visits/reviews and the identity of the designated pharmacist must be documented and readily retrievable at the request of the board or the board's authorized designee. The permit holder shall remain responsible for Class O ADS services and ensuring proper functioning.
(H) An ongoing and documented quality assurance program must be established to monitor the performance of the Class O ADS. The quality assurance program must include procedures for handling and reporting dispensing errors, system malfunctions, and other compliance concerns.
(I) Notification of any dispensing error involving a Class O ADS that is dispensed to the patient must be submitted electronically or in writing to the board within ten (10) days of discovery. The required notification must include the date of the incident, patient name, description of the error, the applicable prescription/medication order number or unique identifier, and any corrective action taken.
(4) Standards of operation. A Class O ADS must be safely and properly operated at all times in compliance with applicable state and federal laws, including but not limited to all applicable controlled substance laws. Medication must be accurately dispensed and labeled.
(A) Medication may only be dispensed by a Class O ADS pursuant to a valid patient-specific prescription or medication order. A Class O ADS may not be used to dispense prescriptions/medication for multiple pharmacies.
(B) The Class O ADS must be supervised at all times it is in operation by a Missouri-licensed pharmacist who is either physically present at the Class O ADS site or who is supervising via an electronic system that allows the pharmacist to adequately view the Class O ADS and supervise all Class O ADS activities. The required pharmacist supervision may not be delegated to an intern pharmacist.
1. The supervising pharmacist must maintain full operational control over the Class O ADS whenever the Class O ADS is in operation, and must be able to terminate or suspend Class O ADS operations when deemed necessary or appropriate.
2. The required electronic system must provide a continuous real-time video link to allow the supervising pharmacist to see the entire Class O ADS site. A two- (2-) way communication mechanism must also be available that allows communication between the supervising pharmacist and any technicians or intern pharmacists present on-site. Medication may not be dispensed and the Class O ADS may not be operated if the required video link and audio communication are not fully functioning.
3. A supervising pharmacist may not supervise more than two (2) Class O ADSs at a time. The identity of the supervising pharmacist must be documented and maintained in the supervising pharmacy's records. Licensees may request a waiver of the supervision limit. The board will consider the factors in subsection (2)(D) when determining waiver requests.
(C) For Class O ADS prescription pick-up systems, only filled and labeled prescriptions that have been verified by a pharmacist may be loaded in or dispensed from the Class O ADS prescription pick-up system, except as otherwise authorized by law. The entire dispensing process must be fully automated after the prescription/medication order is loaded into the Class O prescription pick-up system. No manual manipulation of the prescription/medication order or the affixed label may occur after the prescription/medication order is stocked, restocked, or loaded in the Class O ADS prescription pick-up system.
(D) For Class O ADS ambulatory prescription dispensing systems, the entire prescription/medication order filling, dispensing, and labeling process must be automated and the required prescription/medication label must be affixed by the Class O ADS ambulatory prescription dispensing system prior to dispensing from the Class O ADS ambulatory prescription dispensing system. No manual manipulation of the prescription/medication order or the affixed label may occur after the automated filling process is initiated.
(E) Medication may not be dispensed via a Class O ADS if the patient or the patient's authorized designee requests not to use the Class O ADS.
(5) Patient counseling. An offer to counsel must be made to the patient or the patient's authorized representative prior to a prescription or medication order being dispensed from a Class O ADS, except as otherwise required by law for Class R remote dispensing site pharmacies. The offer to counsel may be made verbally by authorized pharmacy staff or made electronically via the Class O ADS.
(A) Adequate space and equipment must be available to confidentially counsel patients. Live, real-time patient counseling must be provided if counseling is requested by the patient or otherwise required. If a pharmacist is not present on-site, two- (2-) way video and audio technology must be available that allows the pharmacist and patient to both view and communicate with each other. Medication may not be dispensed if the required video and audio technology is not fully functioning.
(B) Video monitors/screens used for patient counseling or communication must be a minimum of twelve inch (12") wide diagonally. Backlighting or other factors that may inhibit video performance must be taken into account when using video technology to counsel/communicate with patients.
(C) A sign must be conspicuously posted or continuously displayed electronically on the Class O ADS informing patients that a pharmacist will provide counseling either in-person or via the video/audio system on request. The sign must include clear instructions for requesting counseling and must be easily viewed and readable by the public.
(6) Stocking/restocking. Medication must be securely stocked, loaded, and reloaded in a Class O ADS in a manner that protects against theft or diversion, and in compliance with 20 CSR 2220-2.010.
(A) Only board licensees or registrants may stock, load, or restock a Class O ADS, as authorized by the supervising pharmacy's policies and procedures.
(B) For Class O ADS prescription pick-up systems, a pharmacist must physically verify that prescriptions/medication orders have been properly loaded into the Class O ADS prescription pick-up system. The identity of the verifying pharmacist must be documented and maintained in the pharmacy's records. Alternatively, an electronic verification system may be used to verify that prescriptions/medication orders have been properly loaded into the Class O ADS prescription pick-up system, if no manual intervention with the prescription/ medication order occurs after the electronic verification is completed. If authorized by a pharmacist, intern pharmacists or pharmacy technicians may load a Class O ADS prescription pick-up system without a pharmacist present or additional pharmacist verification if-
1. An electronic verification system is used to verify the prescription/medication order has been properly loaded into the ADS system;
2. No manual intervention with the prescription/medication order occurs after the electronic verification required by this subsection, other than removing the prescription/ medication order by authorized pharmacy staff for return/ destruction; and
3. The electronic verification system has been validated and revalidated as required by subsection (3)(F). Validation dates and results must be documented in writing and readily retrievable.
(C) For Class O ADS ambulatory prescription dispensing systems, an electronic verification system must be used to verify that medication or medication containers have been properly stocked, restocked, and loaded into the Class O ADS ambulatory prescription dispensing system. If authorized by a pharmacist, intern pharmacists or pharmacy technicians may stock, restock, or load manufacturer unit of use packages and repacked containers previously verified by a pharmacist into a Class O ADS ambulatory prescription dispensing system without a pharmacist present or additional pharmacist verification if-
1. An electronic verification system is used to verify the medication has been correctly stocked, restocked, or loaded;
2. No manual intervention with the manufacturer unit of use package or repacked container occurs after the required electronic verification required by this subsection occurs, other than removing the manufacturer unit of use package or repacked container by authorized pharmacy staff for return/ destruction; and
3. The electronic verification system has been validated and revalidated as required by subsection (3)(F). Validation dates and results must be documented in writing and readily retrievable.
(D) Return-to-stock medication may be returned and reused as authorized by 20 CSR 2220-3.040 or 20 CSR 2220-2.145 governing multi-med dispensing. No medication shall be returned directly to a Class O ADS for reissue or reuse by a person not licensed or registered by the Board of Pharmacy.
(E) The following documentation must be maintained and readily retrievable:
1. The date and time prescriptions/medication orders are stocked, loaded, restocked, and removed from the Class O ADS system;
2. The date and time medications are stocked, loaded, restocked, and removed from the Class O ADS system;
3. The identity of individuals stocking, loading, restocking, or removing prescriptions/medication orders and medication in the system; and
4. For Class O ADS ambulatory prescription dispensing systems, the identity of the pharmacist responsible for verifying the contents of any manufacturer unit of use packages and repacked containers stocked, restocked, or loaded into the Class O ADS ambulatory prescription dispensing system by an intern pharmacist or pharmacy technician without a pharmacist present.
(7) Security. Adequate security and supervision must be maintained to prevent medication theft and diversion and unauthorized access to or use of the Class O ADS. Class O ADS permit holders must comply with all security provisions of this rule and 20 CSR 2220-2.010. Confidential records must be securely maintained to prevent unauthorized access to, and unauthorized storage/transfer of, confidential information.
(A) A Class O ADS must be securely placed, locked, and maintained at the address licensed by the board in a manner that prevents theft, diversion, or unauthorized access, or medication removal. Authorized access to the Class O ADS must be defined in the permit holder's policy and procedures.
(B) In addition to the requirements of section (8), written policies and procedures must be in place to immediately access, secure, remove, and store medication in the event of an emergency or security breach.
(C) The Class O ADS must have an alarm mechanism that promptly alerts a designated member(s) of the pharmacy's staff in the event of a security breach or unauthorized access to the Class O ADS. For Class O ADSs located outside of a Missouri-licensed pharmacy, the alarm must also alert local law enforcement in the event of a security breach or unauthorized access to the Class O ADS, if available. Additionally, a board licensee or registrant located in Missouri must have the authority to access and suspend operations of the Class O ADS if necessary.
(D) Confirmed or suspected security breaches of the Class O ADS must be immediately investigated. If confirmed, use/ operation of the Class O ADS must immediately cease until the security breach has been rectified and proper security is restored. All security breaches of the Class O ADS must be documented and reported to the board in writing within three (3) business days of discovery.
(E) Any confirmed or suspected medication diversion/theft must be immediately investigated. Medication diversion/theft must be reported to the board in writing within three (3) business days of discovery.
(F) A perpetual inventory must be maintained for each Class O ambulatory prescription dispensing system stocking controlled substances that is reconciled by pharmacy staff on a monthly basis.
(8) Policies and procedures. Class O permit holders must maintain current and accurate written policies and procedures governing all aspects of Class O ADS activities, including but not limited to-
(A) Staff education and training;
(B) Maintaining the Class O ADS and the accompanying electronic verification process in good working order;
(C) Maintaining and protecting system data and confidential information;
(D) Granting, restricting, or terminating Class O ADS system access;
(E) Filling, stocking, restocking, and loading the Class O ADS;
(F) Removing expired, adulterated, misbranded, or recalled medication;
(G) Temperature monitoring and documentation;
(H) Prescription processing, verification, and recordkeeping;
(I) Patient counseling;
(J) Ensuring cleanliness and sanitary operation of the Class O ADS and preventing cross-contamination of cells, cartridges, containers, cassettes, or packages;
(K) Emergency response procedures, including but not limited to addressing power outages and terminating and restarting Class O ADS operations;
(L) Monitoring medication inventory to prevent diversion, theft, or loss, including an escalation policy/procedure for addressing inventory discrepancies;
(M) Security requirements, including policies/procedures for authorizing Class O ADS access and terminating Class O ADS operations in the event of a confirmed or suspected security breach, inventory discrepancy, suspected loss/diversion, loss of patient confidential information, and unauthorized access to the Class O ADS;
(N) Receiving, handling, documenting, and investigating alarm notifications/alerts in the event of a security breach of the Class O ADS;
(O) Conducting routine and preventive system validation and maintenance of the Class O ADS;
(P) Quality assurance;
(Q) Handling, investigating, and reporting dispensing errors;
(R) Recordkeeping; and
(S) Data retention and retrieval.
(9) Records.
(A) Class O permit holders must maintain readily retrievable records of all Class O ADS transactions, including but not limited to all prescriptions and medication orders processed and/ or dispensed by the Class O ADS and records of all medication stocked in or removed from the Class O ADS.
(B) Prescriptions and medication orders dispensed from a Class O ADS must be separately identifiable in the pharmacy's prescription records and individually retrievable from other prescriptions/medication orders maintained by the pharmacy. This requirement also applies to any Class J pharmacy dispensing prescriptions via a Class O ADS.
(C) Except as otherwise provided by this rule or other applicable law, all records required by this rule must be maintained for a minimum of two (2) years and readily retrievable on request of the board or a board-authorized designee. Records maintained at a pharmacy must be produced immediately or within two (2) hours of a request from the board or the board's authorized designee, or by making a computer terminal available to the inspector for immediate use to review the records requested. Records not maintained at a pharmacy must be produced within three (3) business days of a board request.