| (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.
(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.
Cont'd... |
