| (i) Prescription drug orders for Schedules III-V controlled
substances may not be refilled more than five times or after six months
from the date of issuance of the original prescription drug order,
whichever occurs first.
(ii) If a prescription drug order for a Schedule III,
IV, or V controlled substance has been refilled a total of five times
or if six months have expired from the date of issuance of the original
prescription drug order, whichever occurs first, a new and separate
prescription drug order shall be obtained from the prescribing practitioner
prior to dispensing any additional quantities of controlled substances.
(D) Pharmacist unable to contact prescribing practitioner.
If a pharmacist is unable to contact the prescribing practitioner
after a reasonable effort, a pharmacist may exercise his professional
judgment in refilling a prescription drug order for a drug, other
than a Schedule II controlled substance, 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 72-hour supply;
(iii) 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;
(iv) the pharmacist informs the practitioner of the
emergency refill at the earliest reasonable time;
(v) the pharmacist maintains a record of the emergency
refill containing the information required to be maintained on a prescription
as specified in this subsection;
(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 Schedule II controlled substance, 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 patient 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 Schedules IV and V controlled substances.
Schedules 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.
Cont'd... |
