Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This amendment establishes licensure
exemptions for pharmacies engaged in sharing services with a Class Q Charitable
Pharmacy.
(1) Definitions.
(A) "Charitable organization"-An organization
qualified as a charitable organization pursuant to section 501(c)(3) of the
Internal Revenue Code.
(B)
"Charitable pharmacy"-A site in Missouri that is owned or operated by a
charitable organization for purposes of providing pharmacy services to
appropriately screened and qualified indigent patients. Class Q pharmacies may
only provide services to or for qualified indigent patients.
(C) "Health care entity"-A hospital owned by
the State of Missouri or any entity or organization that is licensed or
certified by the state or federal government as a hospital, hospice facility,
ambulatory surgical center, nursing home, long-term care facility, residential
care facility, skilled nursing facility, mental/behavioral health care
facility, or a habilitation center as defined by Chapter 630, RSMo, and that is
required to maintain patient records by state or federal law.
(D) "Qualified indigent patient"-A patient of
a charitable pharmacy that has been screened and approved by a charitable
organization and deemed not to have sufficient funds to obtain needed
medication based on the charitable organization's pre-established
criteria.
(E) "Qualified intern
pharmacist"-A currently licensed Missouri intern pharmacist who has completed
employer approved training in the activities to be performed at a Class Q
pharmacy and has an initial and, if applicable, annual documented assessment of
competency.
(F) "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 a Class Q pharmacy and has an initial and,
if applicable, 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.
(2) Applications for a Class Q pharmacy must
be submitted on a form approved by the board and must be renewed as provided by
Chapter 338, RSMo, and 20 CSR 2220-2. No application fee is required (initial
or renewal).
(3) Except as
otherwise authorized by the board, Class Q pharmacies must comply with all laws
and regulations applicable to the pharmacy services provided, including but not
limited to 20 CSR 2220-2.010. Class Q
pharmacies/applicants may petition the board to waive designated facility or
pharmacy operational requirements not applicable to the Class Q pharmacy's
operations. Waiver requests must be submitted in writing and must demonstrate
how the permit holder will maintain patient safety and ensure appropriate
patient care and pharmacy security, if approved. Controlled substances must be
handled and dispensed in accordance with state and federal law.
(4) Class Q pharmacy services must be safely
and accurately provided at all times, in compliance with state and federal law.
If authorized by the pharmacist-in-charge, a qualified pharmacy technician or
qualified intern pharmacist may assist in the practice of pharmacy at a Class Q
pharmacy when a pharmacist is absent, with the exception of sterile compounding
activities.
(A) Non-controlled medication may
be dispensed or provided by a Class Q pharmacy when a pharmacist is absent if-
1. A pharmacist has previously verified the
prescription/medication order contents and affixed label; or
2. Medication is provided to a healthcare
provider for administration or delivery to the ultimate user as authorized by
the healthcare provider's scope of practice, and bar code technology is used to
verify the correct medication has been provided for the applicable patient. The
healthcare provider must be notified that the medication has not been verified
by a pharmacist prior to or on delivery.
(B) Patients or the patient's designee must
be offered an opportunity to consult with a pharmacist as required by
20 CSR
2220-2.190. If the pharmacist is not present on site
or unavailable to provide remote patient counseling, a written offer to counsel
with a contact telephone number for a pharmacist must be supplied with the
medication.
(C) If medication is
dispensed or provided without a pharmacist present, a Missouri-licensed
pharmacist designated by the pharmacist-in-charge must visit the Class Q
pharmacy on a weekly basis to review the pharmacy's activities and records to
ensure proper dispensing and compliance with this rule. The name of the
reviewing pharmacist and review date must be documented and maintained in the
pharmacy's records.
(D) The
pharmacy's prescription records must identify any prescription/medication order
dispensed without a pharmacist present.
(5) If authorized by the
pharmacist-in-charge, a Missouri-licensed physician, dentist, physician
assistant, or registered nurse may remove non-controlled medication from the
pharmacy when a pharmacist is not at the Class Q location in an amount or
volume needed to provide or administer to patients on the premises. Medication
may only be removed pursuant to a valid order from a healthcare provider
authorized to prescribe. The Class Q pharmacy must maintain a record of the
distribution that includes the identity of the person removing the medication,
the date removed, and the medication's identity, quantity, strength, and dosage
form. A Missouri-licensed pharmacist must review the required documentation on
a weekly basis to ensure compliance with this rule. Controlled substances may
not be removed or dispensed by a Class Q pharmacy unless a Missouri-licensed
pharmacist is present and supervising.
(6) Donated Medication. A Class Q pharmacy
may accept and dispense donated medication if-
(A) The medication is a non-controlled
substance and is donated by a pharmacy, drug distributor, healthcare entity, or
a healthcare provider who is licensed to prescribe. Donated medication cannot
be accepted from a patient or a member of the public;
(B) The medication has not been previously
dispensed to a patient and is donated in the original, sealed, and unopened
manufacturer or unit of use packaging/container;
(C) The medication is not adulterated,
misbranded, expired, outdated, subject to a recall, or otherwise not
appropriate for patient use. A pharmacist must visually inspect all donated
medication prior to placing the medication in active inventory to ensure the
medication complies with the requirements of this rule;
(D) The donating entity/healthcare provider
attests in writing that the medication has been stored in accordance with
manufacturer or United States Pharmacopeia requirements/guidelines and all
applicable state and federal law;
(E) The Class Q pharmacy maintains a record
of donated medication that identifies the medication received, the donating
entity/healthcare provider, the date received, and the medication's quantity,
strength, lot number, dosage form, and expiration date; and
(F) The parties comply with all applicable
state and federal laws.
(7) Policies and Procedures. Class Q
pharmacies must maintain current and accurate policies and procedures governing
pharmacy operations, including, but not limited to, policies/procedures for the
following, if applicable:
(A) Accepting,
dispensing, or filling prescriptions;
(B) Training pharmacy staff;
(C) Drug storage and security;
(D) Offering patient counseling;
(E) Contacting a pharmacist for consultation
during the pharmacy's business operations or in the event of an
emergency;
(F) If applicable,
procedures for dispensing or providing medication in a pharmacist's absence
pursuant to section (4) of this rule; including, documenting medication
dispensed in the pharmacist's absence, reconciling medication inventory,
notifying healthcare providers as required by subsection (4)(A), and
documenting required healthcare provider notifications;
(G) Receiving, storing, dispensing, and
disposal of donated medication;
(H)
Granting, terminating, and monitoring authorized pharmacy access when a
pharmacist is not present; and
(I)
Reporting and handling of dispensing errors. The pharmacistin-charge must be
notified of a dispensing error within twenty-four (24) hours after the error is
learned by pharmacy staff. Policies/procedures must include the manner of
notification.
(8)
Records. Records required by this rule must be maintained at the pharmacy for a
minimum of two (2) years and must be readily retrievable and made available to
the board or the board's authorized designee upon request.
(9) A Class Q pharmacy receiving a completed
and labeled prescription from another pharmacy to provide to a qualified
indigent patient is not considered to be shared services under
20 CSR
2220-2.650. For prescriptions received from another
pharmacy-
(A) The Class Q pharmacy must
maintain documentation of the prescription received, the name and address of
the pharmacy providing the prescription, the date of receipt, the prescription
number or unique identifier, and the patient's name;
(B) The Class Q pharmacy is responsible for
ensuring compliance with all applicable patient counseling
requirements;
(C) Prior to
dispensing a prescription received from another pharmacy, a pharmacist must
perform a drug utilization review with the patient information available at the
Class Q pharmacy in compliance with
20 CSR
2220-2.195;
(D) If additional manipulation or compounding
is required by the Class Q pharmacy, receipt of a prescription or medication
order is required and the receiving pharmacy must dispense the product as their
own prescription/order. All prescription, record keeping, compounding, and
labeling requirements must be met; and
(E) Licensees shall comply with all
applicable controlled substance laws and regulations, including but not limited
to all applicable security and record keeping requirements.
