(vi) the pharmacist affixes a label to the dispensing
container as specified in §291.33(c)(7) of this title; and
(vii) 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 contains
the essential information;
(II) after a reasonable effort, the pharmacist is unable
to contact the other pharmacy to transfer the remaining prescription
refills or there are no refills remaining on the prescription;
(III) the pharmacist, in his professional judgment,
determines that such a request for an emergency refill is appropriate
and meets the requirements of clause (i) of this subparagraph; and
(IV) the pharmacist complies with the requirements
of clauses (ii) - (vi) of this subparagraph.
(E) Natural or manmade disasters. If a natural or manmade
disaster has occurred that prohibits the pharmacist from being able
to contact the practitioner, a pharmacist may exercise his professional
judgment in refilling a prescription drug order for a drug, other
than a controlled substance listed in Schedule II, without the authorization
of the prescribing practitioner, provided:
(i) failure to refill the prescription might result
in an interruption of a therapeutic regimen or create patient suffering;
(ii) the quantity of prescription drug dispensed does
not exceed a 30-day supply;
(iii) the governor has declared a state of disaster;
(iv) the board, through the executive director, has
notified pharmacies that pharmacists may dispense up to a 30-day supply
of prescription drugs;
(v) the pharmacist informs the patient or the patient's
agent at the time of dispensing that the refill is being provided
without such authorization and that authorization of the practitioner
is required for future refills;
(vi) the pharmacist informs the practitioner of the
emergency refill at the earliest reasonable time;
(vii) the pharmacist maintains a record of the emergency
refill containing the information required to be maintained on a prescription
as specified in this subsection;
(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 contains
the essential information;
(II) after a reasonable effort, the pharmacist is unable
to contact the other pharmacy to transfer the remaining prescription
refills or there are no refills remaining on the prescription;
(III) the pharmacist, in his professional judgment,
determines that such a request for an emergency refill is appropriate
and meets the requirements of clause (i) of this subparagraph; and
(IV) the pharmacist complies with the requirements
of clauses (ii) - (viii) of this subparagraph.
(F) Auto-Refill Programs. A pharmacy may use a program
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 program
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
option 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. Schedule
II and III controlled substances may not be dispensed by an auto-refill
program.
(iv) As is required for all prescriptions, a drug regimen
review shall be completed on all prescriptions filled as a result
of the auto-refill program. Special attention shall be noted for drug
regimen review warnings of duplication of therapy and all such conflicts
shall be resolved with the prescribing practitioner prior to refilling
the prescription.
(9) Records Relating to Dispensing Errors. If a dispensing
error occurs, the following is applicable.
(A) Original prescription drug orders:
(i) shall not be destroyed and must be maintained in
accordance with subsection (a) of this section; and
(ii) shall not be altered. Altering includes placing
a label or any other item over any of the information on the prescription
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
dispensing tag or label in such a manner as to obliterate the information
relating to the error).
(B) 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) may be changed only in compliance with subsection
(e)(2)(B) of this section; and
(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 incorrectly
entered prescription drug order may not be dispensed, or the data
processing system must be capable of maintaining an audit trail showing
any changes made to the data in the system.
(10) 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
periodic 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) A patient medication record system shall be maintained
by the pharmacy for patients to whom prescription drug orders are
dispensed.
(2) The patient medication record system shall provide
for the immediate retrieval of information for the previous 12 months
that 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) The pharmacist-in-charge shall assure that a reasonable
effort is made to obtain and record in the patient medication record
at least the following information:
(A) full name of the patient for whom the drug is prescribed;
(B) address and telephone number of the patient;
(C) patient's age or date of birth;
(D) patient's gender;
(E) any known allergies, drug reactions, idiosyncrasies,
and chronic conditions or disease states of the patient and the identity
of any other drugs currently being used by the patient which may relate
to prospective drug regimen review;
(F) pharmacist's comments relevant to the individual's
drug therapy, including any other information unique to the specific
patient or drug; and
(G) a list of all prescription drug orders dispensed
(new and refill) to the patient by the pharmacy during the last two
years. Such list shall contain the following information:
(i) date dispensed;
(ii) name, strength, and quantity of the drug dispensed;
(iii) prescribing practitioner's name;
(iv) unique identification number of the prescription;
and
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