(4) Each time a modification, change, or manipulation
is made to a record of dispensing, documentation of such change shall
be recorded on the back of the prescription or on another appropriate,
uniformly maintained, readily retrievable record, such as medication
records. The documentation of any modification, change, or manipulation
to a record of dispensing shall include the identification of the
individual responsible for the alteration.
(e) Prescription drug order records maintained in a
data processing system.
(1) General requirements for records maintained in
a data processing system.
(A) Compliance with data processing system requirements.
If a Class A pharmacy's data processing system is not in compliance
with this subsection, the pharmacy must maintain a manual record keeping
system as specified in subsection (d) of this section.
(B) Original prescriptions. Original prescriptions
shall be maintained in three files as specified in subsection (b)(6)(D)
of this section.
(C) Requirements for backup systems.
(i) The pharmacy shall maintain a backup copy of information
stored in the data processing system using disk, tape, or other electronic
backup system and update this backup copy on a regular basis, at least
monthly, to assure that data is not lost due to system failure.
(ii) Data processing systems shall have a workable
(electronic) data retention system that can produce an audit trail
of drug usage for the preceding two years as specified in paragraph
(2)(H) of this subsection.
(D) Change or discontinuance of a data processing system.
(i) Records of dispensing. A pharmacy that changes
or discontinues use of a data processing system must:
(I) transfer the records of dispensing to the new data
processing system; or
(II) purge the records of dispensing to a printout
that contains the same information required on the daily printout
as specified in paragraph (2)(C) of this subsection. The information
on this hard copy printout shall be sorted and printed by prescription
number and list each dispensing for this prescription chronologically.
(ii) Other records. A pharmacy that changes or discontinues
use of a data processing system must:
(I) transfer the records to the new data processing
system; or
(II) purge the records to a printout that contains
all of the information required on the original document.
(iii) Maintenance of purged records. Information purged
from a data processing system must be maintained by the pharmacy for
two years from the date of initial entry into the data processing
system.
(E) Loss of data. The pharmacist-in-charge shall report
to the board in writing any significant loss of information from the
data processing system within 10 days of discovery of the loss.
(2) Records of dispensing.
(A) Each time a prescription drug order is filled or
refilled, a record of such dispensing shall be entered into the data
processing system.
(B) Each time a modification, change or manipulation
is made to a record of dispensing, documentation of such change shall
be recorded in the data processing system. The documentation of any
modification, change, or manipulation to a record of dispensing shall
include the identification of the individual responsible for the alteration.
Should the data processing system not be able to record a modification,
change, or manipulation to a record of dispensing, the information
should be clearly documented on the hard copy prescription.
(C) The data processing system shall have the capacity
to produce a daily hard copy printout of all original prescriptions
dispensed and refilled. This hard copy printout shall contain the
following information:
(i) unique identification number of the prescription;
(ii) date of dispensing;
(iii) patient name;
(iv) prescribing practitioner's name and the supervising
physician's name if the prescription was issued by an advanced practice
registered nurse, physician assistant or pharmacist;
(v) name and strength of the drug product actually
dispensed; if generic name, the brand name or manufacturer of drug
dispensed;
(vi) quantity dispensed;
(vii) initials or an identification code of the dispensing
pharmacist;
(viii) initials or an identification code of the pharmacy
technician or pharmacy technician trainee performing data entry of
the prescription, if applicable;
(ix) if not immediately retrievable via computer display,
the following shall also be included on the hard copy printout:
(I) patient's address;
(II) prescribing practitioner's address;
(III) practitioner's DEA registration number, if the
prescription drug order is for a controlled substance;
(IV) quantity prescribed, if different from the quantity
dispensed;
(V) date of issuance of the prescription drug order,
if different from the date of dispensing; and
(VI) total number of refills dispensed to date for
that prescription drug order; and
(x) any changes made to a record of dispensing.
(D) The daily hard copy printout shall be produced
within 72 hours of the date on which the prescription drug orders
were dispensed and shall be maintained in a separate file at the pharmacy.
Records of controlled substances shall be readily retrievable from
records of non-controlled substances.
(E) Each individual pharmacist who dispenses or refills
a prescription drug order shall verify that the data indicated on
the daily hard copy printout is correct, by dating and signing such
document in the same manner as signing a check or legal document (e.g.,
J.H. Smith, or John H. Smith) within seven days from the date of dispensing.
(F) In lieu of the printout described in subparagraph
(C) of this paragraph, the pharmacy shall maintain a log book in which
each individual pharmacist using the data processing system shall
sign a statement each day, attesting to the fact that the information
entered into the data processing system that day has been reviewed
by him or her and is correct as entered. Such log book shall be maintained
at the pharmacy employing such a system for a period of two years
after the date of dispensing; provided, however, that the data processing
system can produce the hard copy printout on demand by an authorized
agent of the Texas State Board of Pharmacy. If no printer is available
on site, the hard copy printout shall be available within 72 hours
with a certification by the individual providing the printout, stating
that the printout is true and correct as of the date of entry and
such information has not been altered, amended, or modified.
(G) The pharmacist-in-charge is responsible for the
proper maintenance of such records, for ensuring that such data processing
system can produce the records outlined in this section, and that
such system is in compliance with this subsection.
(H) The data processing system shall be capable of
producing a hard copy printout of an audit trail for all dispensing
(original and refill) of any specified strength and dosage form of
a drug (by either brand or generic name or both) during a specified
time period.
(i) Such audit trail shall contain all of the information
required on the daily printout as set out in subparagraph (C) of this
paragraph.
(ii) The audit trail required in this subparagraph
shall be supplied by the pharmacy within 72 hours, if requested by
an authorized agent of the Texas State Board of Pharmacy.
(I) Failure to provide the records set out in this
subsection, either on site or within 72 hours constitutes prima facie
evidence of failure to keep and maintain records in violation of the
Act.
(J) The data processing system shall provide online
retrieval (via computer display or hard copy printout) of the information
set out in subparagraph (C) of this paragraph of:
(i) the original controlled substance prescription
drug orders currently authorized for refilling; and
(ii) the current refill history for Schedules III,
IV, and V controlled substances for the immediately preceding six-month
period.
(K) In the event that a pharmacy using a data processing
system experiences system downtime, the following is applicable:
(i) an auxiliary procedure shall ensure that refills
are authorized by the original prescription drug order and that the
maximum number of refills has not been exceeded, or authorization
from the prescribing practitioner shall be obtained prior to dispensing
a refill; and
Cont'd... |