| (ii) rational therapy--contraindications;
(iii) reasonable dose and route of administration;
(iv) reasonable directions for use;
(v) duplication of therapy;
(vi) drug-drug interactions;
(vii) drug-food interactions;
(viii) drug-disease interactions;
(ix) adverse drug reactions;
(x) proper utilization, including overutilization or
underutilization; and
(xi) clinical laboratory or clinical monitoring methods
to monitor and evaluate drug effectiveness, side effects, toxicity,
or adverse effects, and appropriateness to continued use of the drug
in its current regimen.
(B) A retrospective, random drug regimen review as
specified in the pharmacy's policies and procedures shall be conducted
on a periodic basis to verify proper usage of drugs not to exceed
31 days between such reviews.
(C) Any questions regarding the order must be resolved
with the prescriber and a written notation of these discussions made
and maintained.
(e) Records.
(1) Maintenance of records.
(A) Every inventory or other record required to be
kept under the provisions of this section (relating to Pharmacies
Located in a Freestanding Emergency Medical Care Facility (Class F)
shall be:
(i) kept by the pharmacy and be available, for at least
two years from the date of such inventory or record, for inspecting
and copying by the board or its representative, and other authorized
local, state, or federal law enforcement agencies; and
(ii) supplied by the pharmacy within 72 hours, if requested
by an authorized agent of the board. If the pharmacy maintains the
records in an electronic format, the requested records must be provided
in a mutually agreeable electronic format if specifically requested
by the board or its representative. Failure to provide the records
set out in this subsection, either on site or within 72 hours, constitutes
prima facie evidence of failure to keep and maintain records in violation
of the Act.
(B) Records of controlled substances listed in Schedule
II shall be maintained separately and readily retrievable from all
other records of the pharmacy.
(C) Records of controlled substances listed in Schedules
III - V shall be maintained separately or readily retrievable from
all other records of the pharmacy. For purposes of this subparagraph,
"readily retrievable" means that the controlled substances shall be
asterisked, redlined, or in some other manner readily identifiable
apart from all other items appearing on the record.
(D) Records, except when specifically required to be
maintained in original or hard copy form, may be maintained in an
alternative data retention system, such as a data processing or direct
imaging system, provided:
(i) the records in the alternative data retention system
contain all of the information required on the manual record; and
(ii) the alternative data retention system is capable
of producing a hard copy of the record upon the request of the board,
its representative, or other authorized local, state, or federal law
enforcement or regulatory agencies.
(E) Controlled substance records shall be maintained
in a manner to establish receipt and distribution of all controlled
substances.
(F) An FEMCF pharmacy shall maintain a perpetual inventory
of controlled substances listed in Schedules II - V which shall be
verified by a pharmacist for completeness and reconciled at least
once in every calendar week that the pharmacy is open.
(G) Distribution records for controlled substances,
listed in Schedules II - V, shall include the following information:
(i) patient's name;
(ii) practitioner's name who ordered the drug;
(iii) name of drug, dosage form, and strength;
(iv) time and date of administration to patient and
quantity administered;
(v) signature or electronic signature of individual
administering the controlled substance;
(vi) returns to the pharmacy; and
(vii) waste (waste is required to be witnessed and
cosigned, manually or electronically, by another individual).
(H) The record required by subparagraph (G) of this
paragraph shall be maintained separately from patient records.
(I) A pharmacist shall conduct an audit by randomly
comparing the distribution records required by subparagraph (G) of
this paragraph with the medication orders in the patient record on
a periodic basis to verify proper administration of drugs not to exceed
30 days between such reviews.
(2) Patient records.
(A) Each medication order or set of orders issued together
shall bear the following information:
(i) patient name;
(ii) drug name, strength, and dosage form;
(iii) directions for use;
(iv) date; and
(v) signature or electronic signature of the practitioner
or that of his or her authorized agent, defined as a licensed nurse
employee or consultant/full or part-time pharmacist of the FEMCF.
(B) Medication orders shall be maintained with the
medication administration record in the medical records of the patient.
(3) General requirements for records maintained in
a data processing system.
(A) If an FEMCF pharmacy's data processing system is
not in compliance with the board's requirements, the pharmacy must
maintain a manual recordkeeping system.
(B) The facility 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 to assure
that data is not lost due to system failure.
(C) 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 which contains:
(I) all of the information required on the original
document; or
(II) for records of distribution and return for all
controlled substances, the same information as required on the audit
trail printout as specified in subparagraph (F) of this paragraph.
The information on the printout shall be sorted and printed by drug
name and list all distributions and returns chronologically.
(D) 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) 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.
(F) The data processing system shall have the capacity
to produce a hard copy printout of an audit trail of drug distribution
and return for any strength and dosage form of a drug (by either brand
or generic name or both) during a specified time period. This printout
shall contain the following information:
(i) patient's name or patient's facility identification
number;
(ii) prescribing or attending practitioner's name;
(iii) name, strength, and dosage form of the drug product
actually distributed;
(iv) total quantity distributed from and returned to
the pharmacy;
(v) if not immediately retrievable via electronic image,
the following shall also be included on the printout:
(I) prescribing or attending practitioner's address;
and
(II) practitioner's DEA registration number, if the
medication order is for a controlled substance.
(G) An audit trail printout for each strength and dosage
form of the drugs distributed during the preceding month shall be
produced at least monthly and shall be maintained in a separate file
at the facility. The information on this printout shall be sorted
by drug name and list all distributions/returns for that drug chronologically.
(H) The pharmacy may elect not to produce the monthly
audit trail printout if the data processing system has a workable
(electronic) data retention system which can produce an audit trail
of drug distribution and returns for the preceding two years. The
audit trail required in this clause shall be supplied by the pharmacy
within 72 hours, if requested by an authorized agent of the board,
or other authorized local, state, or federal law enforcement or regulatory
agencies.
Cont'd... |
