Mississippi Administrative Code
Title 30 - Professions and Occupations
Part 3001 - MISSISSIPPI PHARMACY PRACTICE REGULATIONS
Article XXXIX - AUTOMATED PHARMACY SYSTEMS
Universal Citation: MS Code of Rules XXXIX
Current through September 24, 2024
1. Automated pharmacy systems include, but are not limited to, mechanical systems that perform operations or activities relative to the storage, packaging, delivery, or distribution of medications, and which collects, controls and maintains all transaction information. Every pharmacy that utilizes any such automated medication delivery system shall comply with the following.
2. PERSONNEL
The pharmacist-in-charge shall have the following responsibilities:
A. Assuring that the
automated pharmacy system is in good working order and accurately delivers the
correct strength, dosage form and quantity of the medication prescribed while
maintaining appropriate record-keeping and security safeguards; and
B. Implementing an ongoing quality assurance
program that monitors performance of the automated pharmacy system, which is
evidenced by written policies and procedures developed by the pharmacy;
and
C. Providing the Board with
prior written notice of the installation or removal of any automated pharmacy
system. Such notice must include the name and address of the pharmacy, the
location of the automated equipment and the identification of the responsible
pharmacist.
3. PHARMACY PRACTICE
Automated pharmacy systems can be utilized in permitted pharmacies, remote locations wherein patients are receiving pharmaceutical care by the pharmacist and/or pharmacy responsible for the automated pharmacy system, and other health care facilities, provided they are under the jurisdiction of the Board. The pharmacist-in-charge shall be responsible for the following:
A. Documentation as to
type of equipment, serial numbers, content, policies and procedures and
location shall be maintained onsite in the pharmacy for review by the Board.
Such documentation may include, but is not limited to:
(1) Name and address of the pharmacy and/or
licensed health care facility where the automated pharmacy system(s) is being
used; and
(2) Manufacturer's name
and model; and
(3) Description of
how the device is used; and
(4)
Quality assurance procedures to determine continued appropriate use of the
automated device; and
(5) Policies
and procedures for system operation, safety, security, accuracy, patient
confidentiality, access and malfunction.
B. Automated pharmacy systems should be used
only in settings where there is a program of pharmaceutical care which provides
that medication orders are reviewed by a pharmacist in accordance with
established policies and procedures. The delivery of a "first dose" or an
"emergency dose" may take place without prior order review by a pharmacist,
provided appropriate security and patient medication management controls are in
place.
C. All policies and
procedures must be maintained in the pharmacy responsible for the system. If
the system is not within the facility where the pharmacy is located, policies
and procedures must be maintained at the location where the system is being
used.
D. Automated pharmacy systems
shall have adequate security systems and procedures, evidenced by written
polices and procedures, to:
(1) Prevent
unauthorized access and to comply with federal and state regulations;
and
(2) Maintain patient
confidentiality.
E.
Records and/or electronic data kept by automated pharmacy systems shall meet
the following requirements:
(1) All events
involving the contents of the automated pharmacy system must be recorded
electronically; and
(2) Records
must be maintained by the pharmacy and must be readily available to the Board.
Such records shall include:
(a) Identity of
system accessed; and
(b)
Identification of the individual accessing the system; and
(c) Type of transaction; and
(d) Name, strength, dosage form and quantity
of the drug accessed and/or removed; and
(e) Name of the patient for whom the drug was
ordered and a record in the automated pharmacy system or other readily
retrievable system of the name of the prescriber; and
(f) Such additional information as the
pharmacist-in-charge may deem necessary.
F. Access to, and limits on access (e.g.
security levels) to the automated pharmacy system must be defined by policy and
procedures and must comply with state and federal regulations.
G. The pharmacist-in-charge shall be
responsible for:
(1) Assigning, discontinuing
or changing access to the system; and
(2) Ensuring that access to the medications
comply with state and federal regulations; and
(3) Ensuring that the automated pharmacy
system is filled/stocked/replenished accurately and in accordance with
established written policies and procedures.
H. The filling/stocking/replenishing of all
medications in the automated pharmacy system shall be accomplished by qualified
personnel under the supervision of a pharmacist licensed by the
Board.
I. A record of the
medications filled/stocked/replenished in an automated pharmacy system shall be
maintained for a period of two (2) years and shall include identification of
the persons filling/stocking/replenishing and checking for accuracy.
J. All containers of medications stored in an
automated pharmacy system shall be packaged and labeled in accordance with
federal and state laws and regulations.
K. The automated pharmacy system must have
the capability to produce a hard copy printout of the utilization of controlled
substances maintained in each automated pharmacy system. All aspects of
handling controlled substances shall meet the requirements of all state and
federal laws and regulations.
L.
The automated pharmacy systems shall provide a mechanism for securing and
accounting for medications removed from and subsequently returning to the
equipment, all in accordance with existing state and federal law.
M. The automated pharmacy system shall
provide a mechanism for securing and accounting for wastage of medications or
discarded medications in accordance with state and federal law and/or
regulations.
Disclaimer: These regulations may not be the most recent version. Mississippi may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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