(III) date of each dispensing;
(IV) quantity dispensed at each dispensing;
(V) initials or identification code of the dispensing
pharmacist;
(VI) initials or identification code of the pharmacy
technician or pharmacy technician trainee preparing the prescription
label, if applicable; and
(VII) total number of refills for the prescription.
(B) If refill records are maintained in accordance
with subparagraph (A)(ii) of this paragraph, refill records for controlled
substances in Schedules III-V shall be maintained separately from
refill records of dangerous drugs and nonprescription drugs.
(3) Authorization of refills. Practitioner authorization
for additional refills of a prescription drug order shall be noted
on the original prescription, in addition to the documentation of
dispensing the refill as specified in subsection (l) of this section.
(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 or electronically 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.
Cont'd... |