| (v) signature or electronic signature of person returning
the drug or device.
(8) Policies and procedures. Written policies and procedures
for a drug distribution system, appropriate for the freestanding emergency
medical facility, shall be developed and implemented by the pharmacist-in-charge
with the advice of the appropriate committee. The written policies
and procedures for the drug distribution system shall include, but
not be limited to, procedures regarding the following:
(A) controlled substances;
(B) investigational drugs;
(C) prepackaging and manufacturing;
(D) medication errors;
(E) orders of physician or other practitioner;
(F) floor stocks;
(G) adverse drug reactions;
(H) drugs brought into the facility by the patient;
(I) self-administration;
(J) emergency drug tray;
(K) formulary, if applicable;
(L) drug storage areas;
(M) drug samples;
(N) drug product defect reports;
(O) drug recalls;
(P) outdated drugs;
(Q) preparation and distribution of IV admixtures;
(R) procedures for supplying drugs for postoperative
use, if applicable;
(S) use of automated medication supply systems;
(T) use of data processing systems; and
(U) drug regimen review.
(9) Drugs supplied for outpatient use. Drugs provided
to patients for take home use shall be supplied according to the following
procedures.
(A) Drugs may only be supplied to patients who have
been admitted to the FEMCF.
(B) Drugs may only be supplied in accordance with the
system of control and accountability established for drugs supplied
from the FEMCF; such system shall be developed and supervised by the
pharmacist-in-charge or staff pharmacist designated by the pharmacist-in-charge.
(C) Only drugs listed on the approved outpatient drug
list may be supplied; such list shall be developed by the pharmacist-in-charge
and the medical staff and shall consist of drugs of the nature and
type to meet the immediate postoperative needs of the FEMCF patient.
(D) Drugs may only be supplied in prepackaged quantities
not to exceed a 72-hour supply in suitable containers and appropriately
prelabeled (including name, address, and phone number of the facility
and necessary auxiliary labels) by the pharmacy, provided, however
that topicals and ophthalmics in original manufacturer's containers
may be supplied in a quantity exceeding a 72-hour supply.
(E) At the time of delivery of the drug, the practitioner
shall complete the label, such that the prescription container bears
a label with at least the following information:
(i) date supplied;
(ii) name of practitioner;
(iii) name of patient;
(iv) directions for use;
(v) brand name and strength of the drug; or if no brand
name, then the generic name of the drug dispensed, strength, and the
name of the manufacturer or distributor of the drug; and
(vi) unique identification number.
(F) After the drug has been labeled, the practitioner
or a licensed nurse under the supervision of the practitioner shall
give the appropriately labeled, prepackaged medication to the patient.
(G) A perpetual record of drugs which are supplied
from the FEMCF shall be maintained which includes:
(i) name, address, and phone number of the facility;
(ii) date supplied;
(iii) name of practitioner;
(iv) name of patient;
(v) directions for use;
(vi) brand name and strength of the drug; or if no
brand name, then the generic name of the drug dispensed, strength,
and the name of the manufacturer or distributor of the drug; and
(vii) unique identification number.
(H) The pharmacist-in-charge, or a pharmacist designated
by the pharmacist-in-charge, shall review the records at least once
in every calendar week that the pharmacy is open.
(10) Drug regimen review.
(A) A pharmacist shall evaluate medication orders and
patient medication records for:
(i) known allergies;
(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 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
Cont'd... |
