Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1.
Policy and
procedures.
Up-to-date written policy and procedures shall be developed
and maintained that explain the operational aspects of the electronic data
processing system and shall:
A.
include examples of output documentation provided by the electronic data
processing system that pertain to dispensing or drug control records;
B. outline steps to be followed when the
electronic data processing system is not operational due to scheduled or
unscheduled system interruption;
C.
outline regular and routine backup file procedures and file maintenance;
and
D. outline audit procedures,
personnel code assignments, and personnel responsibilities.
Subp. 1a.
Entering prescription drug
orders.
When electronic data processing equipment is employed by any
pharmacy, input of drug information may be performed by a prescriber or a
pharmacist. If prescription drug orders are entered by other personnel, the
pharmacist or the prescriber must certify the accuracy of the information
entered and verify the prescription drug order prior to the dispensing of the
medication. The unique identifier of the person entering the prescription drug
order must be retained in the computer record.
Subp. 2.
Minimum requirements.
Electronic data processing equipment, when used to store
prescription information, must:
A. be
structured in such a manner that all prescription drug orders, communicated to
a pharmacy by way of electronic transmission, will be transmitted with no
intervening person having access to the information contained in the
prescription drug order;
B. not
infringe on a patient's freedom of choice of pharmacy provider;
C. guarantee the confidentiality of the
information contained in the system's storage devices and databases;
D. produce a hard copy daily summary of
controlled substance transactions and be capable of producing a hard copy
printout of legend drug transactions going back two years, except that if this
information is already available in hard copy form it is not necessary to
duplicate the data through a computer-generated hard copy;
E. be capable of recording and carrying in
the record all dates of refills of any prescription drug order and the unique
identifier of the pharmacist;
F. be
capable of producing a patient profile indicating all drugs being taken and the
dates and quantities of fills or refills of prescription drug orders dispensed
for the patient and:
(1) in the case of
hospital or long-term care inpatients, these records shall be kept in the
computer system or on hard copy and be immediately retrievable for two years;
and
(2) in all other cases the data
shall be kept in the computer system and be immediately retrievable for at
least two years;
G. be
capable of being reconstructed in the event of a computer malfunction or
accident resulting in destruction of the system's storage devices or
databases;
H. be capable of
producing a printout providing a refill-by-refill audit trail for any specified
strength and dosage form of any controlled substance. The audit trail must
include the name of prescribing practitioner, the name and location of patient,
the quantity dispensed on each refill, the date of dispensing of each refill,
the name or unique identifier of the dispensing pharmacist, and the
prescription number;
I. be capable
of identifying any authorized changes in drug, quantity, or directions for use
of any prescription drug order including the date of change, the identity or
unique identifier of the individual making the change, and what the original
information was; alternatively a new prescription drug order may be created for
each authorized change; and
J. be
capable of preventing unauthorized access, modification, or manipulation of
patient prescription data.
Subp.
3.
Original prescription retained.
In all cases where electronic data processing equipment is
used the original prescription must be retained on file according to law to
assure access to the information contained thereon in the event of a computer
breakdown. Original prescriptions or any other patient specific records stored
outside the licensed pharmacy area must be stored in a secure area accessible
only to registered or licensed pharmacy staff, or others delegated by the
pharmacist-in-charge and trained on the policies and procedures relating to
protected health information.
Subp.
4.
New prescriptions.
A. A pharmacy must develop and implement a
written quality assurance plan that includes a pharmacist, or a
pharmacist-intern working under the immediate and direct supervision of a
pharmacist, comparing the original written prescription or an image of the
original written prescription, to the information entered into the computer,
and documenting the completion and accuracy of this comparison with the date
and unique identifier of the pharmacist or pharmacist-intern completing the
task. This process must not occur prior to two hours after the prescription has
been initially certified, unless it is completed by a second individual
pharmacist as soon as possible after the initial certification has occurred.
The process must be completed within 72 hours.
B. As an alternative to the requirements of
item A, hospitals providing inpatient pharmacy services may elect instead to
develop a plan to provide safeguards against errors being made and perpetuated
due to inaccurate prescription data being entered into the pharmacy's computer.
This written quality assurance plan shall be made available to the board
surveyors upon request.
Subp.
5.
Report to Board of Pharmacy.
If dispensing information is lost due to unscheduled system
interruption, the Board of Pharmacy shall be notified within 72 hours.
Subp. 6.
Computer-generated
material.
Any computer-generated material, such as labels, receipts,
duplicate prescriptions, or other printed matter, that is intended to be
attached to the hard copy prescription to meet legal requirements shall be
affixed so that the face of the prescription is unobstructed.
Statutory Authority: MS s
151.06;
151.102;
152.02
