20 CSR 2220-2.080 - Electronic Prescription Records
PURPOSE: This rule is being amended pursuant to Executive Order 17-03 to remove unnecessary/duplicative rule language and to modernize rule language governing electronic prescription records.
(1) In lieu of a
non-electronic (manual) record-keeping system, a pharmacy may elect to maintain
an electronic data processing (EDP) record keeping-system. All information
concerning the compounding, dispensing, or selling by a pharmacy of any drug,
device, or poison pursuant to a lawful prescription which is entered into an
EDP system at any pharmacy shall be entered only by a licensed pharmacist or by
a technician or intern pharmacist under the direct supervision and review of a
licensed pharmacist. Prior to dispensing, a pharmacist shall personally verify
the accuracy of prescription data entered into the EDP for each original
prescription. The EDP system shall comply with all applicable state and federal
controlled substance laws and regulations.
(2) EDP systems shall comply with the
requirements of section
338.100,
RSMo, and capable of storing and retrieving the following information
concerning the original filling or refilling of any prescription:
(A) A unique, sequential prescription label
number;
(B) If applicable, a unique
readily retrievable identifier;
(C)
Date the prescription was prescribed;
(D) The date the prescription was initially
filled and the date of each refill;
(E) Patient's full name, or if an animal, the
species and owner's name;
(F)
Patient's address or animal owner's address when a prescription prescribes a
controlled substance;
(G)
Prescriber's full name;
(H)
Prescriber's address and Drug Enforcement Administration (DEA) number when a
prescription specifies a controlled substance;
(I) Name, strength and dosage of drug, device
or poison dispensed and any directions for use;
(J) Quantity originally dispensed;
(K) Quantity dispensed on each
refill;
(L) Identity of the
pharmacist responsible for verifying the accuracy of prescription data prior to
dispensing on each original prescription;
(M) Identity of the pharmacist responsible
for reviewing the final product prior to dispensing on each original and refill
prescription, if different from the pharmacist verifying prescription
data;
(N) The number of authorized
refills and quantity remaining;
(O)
Whether generic substitution has been authorized by the prescriber;
(P) The manner in which the prescription was
received by the pharmacy (e.g., written, telephone, electronic, or faxed);
and
(Q) Any other change or
alteration made in the original prescription based on contact with the
prescriber to show a clear audit trail including, but not limited to, a change
in quantity, directions, number of refills, or authority to substitute a
drug.
(3) The information
specified in section (2) shall be required and recorded in the EDP system prior
to dispensing by a pharmacist or pharmacy.
(4) Except as otherwise provided by
20 CSR
2220-2.083, prescription hard copies must be
maintained and filed by either the sequential prescription label number or by a
unique readily retrievable identifier. For verbal, telephone, or electronic
prescriptions, a hard copy representation of the prescription shall be made and
filed which contains all of the information in section (2). Prescription hard
copies must be retrievable at the time of inspection, except as otherwise
provided by 20 CSR
2220-2.010(1)(J). For purposes of
this subsection an "electronic prescription" is defined as provided in
20 CSR
2220-2.085.
(5) If additional refills are authorized and
added to a prescription, a notation indicating the method and source of the
authorization must be a part of the EDP record or hard copy, in that case the
expiration date of the original prescription shall remain the same.
(6) Any hospital pharmacy using an EDP system
licensed by the board, as described in section (1), for outpatient
prescriptions, employee prescriptions, and take-home prescriptions shall
conform to all sections of this rule.
(7) Any EDP system must be capable of
producing the record required by this rule and said records shall be readily
retrievable online. Readily retrievable is defined as providing EDP records
immediately or within two (2) hours of a request by an inspector or by making a
computer terminal available to the inspector for immediate use.
(8) An auxiliary record-keeping system shall
be established for the documentation of refills if the EDP system is
inoperative for any reason. The auxiliary system shall ensure that all refills
are authorized by the original prescription or prescriber. When this EDP system
is restored to operation, the information regarding prescriptions filled and
refilled during the inoperative period shall be entered into the EDP system
within seven (7) working days. However, nothing in this section precludes the
pharmacist from using his/her professional judgment for the benefit of a
patient's health and safety.
(9) If
a prescription is transferred from a pharmacy using an EDP system, a notation
or deactivation must be made on the transferred record to preclude any further
dispensing. If the same prescription is transferred back into the original
pharmacy, it shall be treated as a new record, showing the original date
written and expiration date.
(10)
Prior to or simultaneously with the purging of any EDP system, the permit
holder shall make certain that a record of all prescription activity being
erased exists in readable form, either on paper, microfiche, or electronic
media storage. A pharmacy that desires to discard hard copy prescriptions that
are more than three (3) years old must maintain all prescription information on
microfiche or electronic media. Any process utilizing microfiche must ensure
that all data is available and in readable form. Any pharmacy opting for the
utilization of microfiche records must also maintain a microfiche reader so
that records may be reviewed on-site by pharmacy personnel or board inspectors.
Electronic media storage is defined as any medium such as a computer, floppy
disk or diskette, compact disk (CD), or other electronic device that can
reproduce all prescription information as required by section
338.100,
RSMo, and this rule and is retrievable within three (3) working days.
(11) If coded information exists in the
electronic EDP, the board inspector may request the definitions of the codes
from the pharmacist on duty for immediate review.
(12) The EDP system shall be able to provide
a listing of drug utilization by date for any drug for a minimum of the
preceding twenty-four- (24-) month period that includes the specific drug
product, patient name, or practitioner. If requested to do so, the pharmacy
shall have three (3) working days to provide the report.
(13) The provisions of this rule do not
preempt any federal laws or regulations. If any part of this rule is declared
invalid by a court of law, that declaration shall not affect the other parts of
the rule.
(14) Licensees shall also
comply with all state and federal controlled substance record keeping
requirements, including, any required daily log books or printouts.
Notes
*Original authority: 338.100, RSMo 1939, amended 1971, 1990, 1997, 1999, 2010; 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011 ; and 338.280, RSMo 1951, amended 1971, 1981.
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