| (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, that
states 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 and responsible 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 dispensings
(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 on-line
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 that uses 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
(ii) all of the appropriate data shall be retained
for on-line data entry as soon as the system is available for use
again.
(3) Authorization of refills. Practitioner authorization
for additional refills of a prescription drug order shall be noted
as follows:
(A) on the hard copy prescription drug order;
(B) on the daily hard copy printout; or
(C) via the computer display.
(f) Limitation to one type of recordkeeping system.
When filing prescription drug order information a pharmacy may use
only one of the two systems described in subsection (d) or (e) of
this section.
(g) Transfer of prescription drug order information.
For the purpose of initial or refill dispensing, the transfer of original
prescription drug order information is permissible between pharmacies,
subject to the following requirements.
(1) The transfer of original prescription drug order
information for controlled substances listed in Schedule III, IV,
or V is permissible between pharmacies on a one-time basis only. However,
pharmacies electronically sharing a real-time, on-line database may
transfer up to the maximum refills permitted by law and the prescriber's
authorization.
(2) The transfer of original prescription drug order
information for dangerous drugs is permissible between pharmacies
without limitation up to the number of originally authorized refills.
(3) The transfer is communicated orally by telephone
or via facsimile directly by a pharmacist to another pharmacist; by
a pharmacist to a student-intern, extended-intern, or resident-intern;
or by a student-intern, extended-intern, or resident-intern to another
pharmacist.
Cont'd... |
