Texas Register, Volume 38, Number 26, Pages 4053-4242, June 28, 2013 Page: 4,141
4053-4242 p. ; 28 cm.View a full description of this periodical.
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(viii) the pharmacist affixes a label to the dispensing
container as specified in 291.33(c)(7) of this title; and
(ix) if the prescription was initially filled at another
pharmacy, the pharmacist may exercise his professional judgment in
refilling the prescription provided:
(I) the patient has the prescription container,
label, receipt or other documentation from the other pharmacy that
[which] contains the essential information;
(II) after a reasonable effort, the pharmacist is
unable to contact the other pharmacy to transfer the remaining prescrip-
tion refills or there are no refills remaining on the prescription;
(III) the pharmacist, in his professional judg-
ment, determines that such a request for an emergency refill is
appropriate and meets the requirements of clause (i) of this subpara-
graph; and
(IV) the pharmacist complies with the require-
ments of clauses (ii) - (viii) of this subparagraph.
(F) Auto-Refill Programs. A pharmacy may use a pro-
gram that automatically refills prescriptions that have existing refills
available in order to improve patient compliance with and adherence
to prescribed medication therapy. The following is applicable in order
to enroll patients into an auto-refill program.
(i) Notice of the availability of an auto-refill pro-
gram shall be given to the patient or patient's agent, and the patient
or patient's agent must affirmatively indicate that they wish to enroll in
such a program and the pharmacy shall document such indication.
(ii) The patients or patient's agent shall have the op-
tion to withdraw from such a program at any time.
(iii) Auto-refill programs may be used for refills of
dangerous drugs, and schedule IV and V controlled substances at the
discretion of the pharmacist-in-charge. Schedule II and III controlled
substances may not be dispensed by an auto-refill program.
(iv) As is required for all prescriptions, a drug regi-
men review shall be completed on all prescriptions filled as a result of
the auto-refill program. Special attention shall be noted for drug reg-
imen review warnings of duplication of therapy and all such conflicts
shall be resolved with the prescribing practitioner prior to refilling the
prescription.
(9) [(8)] Records Relating to Dispensing Errors.
(A) For purposes of this subsetion a dispensing erer
is defined as an action committed by a pharmacist or or pharma
personnel that causes thepatient or patient's agent to take session of
a dispensed pres rip ion drug and an individual subsequently diseoversa
that the patient has received an incorrect drug product, which includes
incorrect strength incorret dosage form andlor incorrect directions
for ue_]
[(B)] If a dispensing error occurs, the following is ap-
plicable.
(A) [(i)] Original prescription drug orders:
i_ [(14)] shall not be destroyed and must be main-
tained in accordance with subsection (a) of this section; and
(ii) [(tI)] shall not be altered. Altering includes plac-
ing a label or any other item over any of the information on the prescrip-
tion drug order (e.g., a dispensing tag or label that is affixed to back of a
prescription drug order must not be affixed on top of another dispensingtag or label in such a manner as to obliterate the information relating
to the error).
(B) [(ii)] Prescription drug order records maintained in
a data processing system:
_ [(I)] shall not be deleted and must be maintained
in accordance with subsection (a) of this section;
(ii) [(11)] may be changed only in compliance with
subsection (e)(2)(B) of this section; and
(iii) [(III)] if the error involved incorrect data entry
into the pharmacy's data processing system, this record must be either
voided or cancelled in the data processing system, so that the incor-
rectly entered prescription drug order may not be dispensed, or the data
processing system must be capable of maintaining an audit trail show-
ing any changes made to the data in the system.
(10) [(9)] Accelerated refills. In accordance with
562.0545 of the Act, a pharmacist may dispense up to a 90-day supply
of a dangerous drug pursuant to a valid prescription that specifies
the dispensing of a lesser amount followed by periodic refills of that
amount if:
(A) the total quantity of dosage units dispensed does not
exceed the total quantity of dosage units authorized by the prescriber
on the original prescription, including refills;
(B) the patient consents to the dispensing of up to a
90-day supply and the physician has been notified electronically or by
telephone;
(C) the physician has not specified on the prescription
that dispensing the prescription in an initial amount followed by peri-
odic refills is medically necessary;
(D) the dangerous drug is not a psychotropic drug used
to treat mental or psychiatric conditions; and
(E) the patient is at least 18 years of age.
(c) Patient medication records.
(1) (No change.)
(2) The patient medication record system shall provide
for the immediate retrieval of information for the previous 12 months
that [which] is necessary for the dispensing pharmacist to conduct a
prospective drug regimen review at the time a prescription drug order
is presented for dispensing.
(3) - (5) (No change.)
(d) Prescription drug order records maintained in a manual
system.
(1) Original prescriptions shall be maintained in three files
as specified in subsection (b)(6)(D) [(b)(5)(D)] of this section.
(2) Refills.
(A) Each time a prescription drug order is refilled, a
record of such refill shall be made:
(i) (No change.)
(ii) on another appropriate, uniformly maintained,
readily retrievable record, such as medication records, that [which] in-
dicates by patient name the following information:
(I) - (VII) (No change.)
(B) (No change.)PROPOSED RULES June 28, 2013 38 TexReg 4141
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Texas. Secretary of State. Texas Register, Volume 38, Number 26, Pages 4053-4242, June 28, 2013, periodical, June 28, 2013; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth313178/m1/89/: accessed April 18, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.