Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This amendment updates licensing and
policy/procedure requirements for Class J Shared Services
pharmacies.
(1) Class J
Shared Services. A Class J Shared Services permit is required if two (2) or
more pharmacies are engaged in, or have an arrangement to provide, functions
related to the practice of pharmacy for or on behalf of the other pharmacy.
These functions may include, but are not limited to, prescription/order
receipt, prescription/order clarification or modification, obtaining prescriber
authorization, data entry, compounding, dispensing, pharmacist verification,
patient counseling, patient profile maintenance, medication therapy services,
medication administration, drug utilization review (DUR), and obtaining refill
authorization. All pharmacies participating in the shared services arrangement
must have a Class J permit.
(A) Pharmacies may
perform Class J Shared Services provided the parties-
1. Have the same owner or have a written
contract outlining the services to be provided and the responsibilities of each
party in fulfilling the terms of said contract in compliance with federal and
state laws and regulations;
2.
Maintain a separate Class J classification for each location involved in
providing shared services; and
3.
Either share a common database or have access to each pharmacy's prescription
records and patient profiles and records, as needed to safely and properly
perform the shared services activities.
(B) Class-J pharmacies operating in
compliance with this section are exempt from the requirements of
20
CSR 2220-2.120 and
20 CSR
2220-6.030(4) when transferring
prescription information between themselves. A Class-J permit is not required
to transfer an individual prescription as authorized by
20
CSR 2220-2.120 pursuant to a request by the patient or
the patient's authorized designee.
(C) The parties performing Class J Shared
Services shall maintain a detailed written description of authorized shared
services that includes the name, address, and permit number(s) of all
pharmacies involved. The parties must maintain a current and accurate policy
and procedure manual that includes, but is not limited to, the following:
1. Policies and procedures that identify the
duties and responsibilities of each pharmacy including any functions identified
in section (1). The required policies and procedures must also identify the
pharmacy responsible for-
A. Verifying
prescription/medication order accuracy and validity;
B. Data entry verification;
C. Drug utilization review as required by 20
CSR 22202.195;
D. Final product
verification; and
E. Patient
counseling;
2. A
mechanism for tracking the prescription or medication order during each step in
the process;
3. Security provisions
for protecting the confidentiality and integrity of patient
information;
4. Policies and
procedures to ensure the safe and appropriate delivery of prescription drugs in
compliance with 20 CSR 22202.013; and
5. A designation of the pharmacy responsible
for offering patient counseling as required by
20 CSR
2220-2.190 and federal law. For purposes of section
338.059,
RSMo, the name and address of either the pharmacy responsible for offering
patient counseling or the pharmacy responsible for dispensing to the patient
may be listed on the label as designated by the pharmacies by
contract.
(D) Each
pharmacy involved in a Class-J arrangement must maintain a quality assurance
program that is designed to objectively and systematically monitor and evaluate
the quality and appropriateness of pharmacy services and resolve identified
problems.
(E) Compounding may only
be performed pursuant to a Class-J pharmacy arrangement pursuant to a
patient-specific prescription or in anticipation of a patient-specific
prescription as authorized by
20 CSR
2220-2.200 and the rules of the board.
(F) A Class-J permit is not required for
pharmacists performing non-dispensing activities authorized by
20 CSR
2220-6.050 outside of a licensed
pharmacy.
(2) A Class J
Shared services permit shall not be required if a completed and labeled
prescription is delivered from a Missouri licensed pharmacy to another Missouri
licensed pharmacy for administration by a pharmacist or other licensed health
care professional to the patient on the same premises or physical location as
the pharmacy.
(A) The exemption recognized in
this subsection only applies if a completed and labeled prescription is
delivered to the receiving pharmacy.
(B) If additional manipulation or compounding
is required by the receiving pharmacy, receipt of a prescription or order is
required and the receiving pharmacy must dispense the product as their own
prescription/order. All prescription requirements, record keeping, compounding,
and labeling requirements must be met.
(C) The receiving pharmacy must maintain
documentation of the medication received, the name and address of the pharmacy
providing the medication, the date of receipt, and the patient's
name.
(D) The receiving pharmacy is
responsible for ensuring compliance with all applicable patient counseling
requirements.
(E) For purposes of
this rule, administration is defined as applying or introducing medication to
the body of a patient, whether by injection, infusion, inhalation, ingestion,
or other means.
(F) Medication
administered by a pharmacist must be performed in compliance with all
applicable provisions of law.
(G)
Notwithstanding any other provision of this rule, licensees shall comply with
all applicable controlled substance laws and regulations, including, but not
limited to, all applicable security and record keeping requirements.
(3) A Class J Shared Services
permit is not required for pharmacies that have an arrangement to provide only
initial dispensing services for a Class C pharmacy, as allowed under 20 CSR
22202.120(4).
(4) A pharmacy
participating in Class J Shared Services with a pharmacy that is not under
common ownership must notify patients that his/her prescription or medication
order may be filled or compounded by another pharmacy.
(5) All records required by this rule including all
policy and procedure manuals, contracts, quality assurance documentation, or
other agreements must be maintained for two (2) years and must be made
available to the board or its representative upon request.
*Original authority: 338.140, RSMo 1939, amended 1981,
1989, 1997; 338.210, RSMo 1951, amended 2001; 338.220, RSMo 1951; amended 1969,
1981, 1989, 1997, 1999, 2001; 338.240, RSMo 1951; and 338.280, RSMo 1951,
amended 1971, 1981.
