| (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
(v) name or initials of the dispensing pharmacists.
(4) A patient medication record shall be maintained
in the pharmacy for two years. If patient medication records are maintained
in a data processing system, all of the information specified in this
subsection shall be maintained in a retrievable form for two years
and information for the previous 12 months shall be maintained on-line.
A patient medication record must contain documentation of any modification,
change, or manipulation to a patient profile.
(5) Nothing in this subsection shall be construed as
requiring a pharmacist to obtain, record, and maintain patient information
other than prescription drug order information when a patient or patient's
agent refuses to provide the necessary information for such patient
medication records.
(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) of this section.
(2) Refills.
(A) Each time a prescription drug order is refilled,
a record of such refill shall be made:
(i) on the back of the prescription by recording the
date of dispensing, the written initials or identification code of
the dispensing pharmacist, the initials or identification code of
the pharmacy technician or pharmacy technician trainee preparing the
prescription label, if applicable, and the amount dispensed. (If the
pharmacist merely initials and dates the back of the prescription
drug order, he or she shall be deemed to have dispensed a refill for
the full face amount of the prescription drug order); or
(ii) on another appropriate, uniformly maintained,
readily retrievable record, such as medication records, that indicates
by patient name the following information:
(I) unique identification number of the prescription;
(II) name and strength of the drug dispensed;
(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 recordkeeping
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.
Cont'd... |
