| (C) FEMCF pharmacies shall be exempt from the labeling
provisions and patient notification requirements of §562.006
and §562.009 of the Act, as respects drugs distributed pursuant
to medication orders.
(D) In FEMCFs with a full-time pharmacist, if a practitioner
orders a drug for administration to a bona fide patient of the facility
when the pharmacy is closed, the following is applicable:
(i) prescription drugs and devices only in sufficient
quantities for immediate therapeutic needs of a patient may be removed
from the FEMCF pharmacy;
(ii) only a designated licensed nurse or practitioner
may remove such drugs and devices;
(iii) a record shall be made at the time of withdrawal
by the authorized person removing the drugs and devices. The record
shall contain the following information:
(I) name of the patient;
(II) name of device or drug, strength, and dosage form;
(III) dose prescribed;
(IV) quantity withdrawn;
(V) time and date; and
(VI) signature or electronic signature of the person
making the withdrawal;
(iv) the medication order in the patient's chart may
substitute for such record, provided the medication order meets all
the requirements of clause (iii) of this subparagraph;
(v) the pharmacist shall verify the withdrawal of a
controlled substance as soon as practical, but in no event more than
72 hours from the time of such withdrawal; and
(vi) the pharmacist shall verify the withdrawal of
a dangerous drug at a reasonable interval, but such verification must
occur at least once in every calendar week.
(E) In FEMCFs with a part-time or consultant pharmacist,
if a practitioner orders a drug for administration to a bona fide
patient of the FEMCF when the pharmacist is not on duty, or when the
pharmacy is closed, the following is applicable:
(i) prescription drugs and devices only in sufficient
quantities for therapeutic needs may be removed from the FEMCF pharmacy;
(ii) only a designated licensed nurse or practitioner
may remove such drugs and devices;
(iii) a record shall be made at the time of withdrawal
by the authorized person removing the drug or device as described
in clauses (6)(D)(iii) and (iv) of this subsection; and
(iv) the pharmacist shall verify withdrawals at a reasonable
interval, but such verification must occur at least once in every
calendar week that the pharmacy is open.
(7) Floor stock. In facilities using a floor stock
method of drug distribution, the pharmacy shall establish designated
floor stock areas outside of the central pharmacy where drugs may
be stored, in accordance with the pharmacy's policies and procedures.
The following is applicable for removing drugs or devices in the absence
of a pharmacist:
(A) prescription drugs and devices may be removed from
the pharmacy only in the original manufacturer's container or prepackaged
container;
(B) only a designated licensed nurse or practitioner
may remove such drugs and devices;
(C) a record shall be made at the time of withdrawal
by the authorized person removing the drug or device and the record
shall contain the following information:
(i) name of the drug, strength, and dosage form;
(ii) quantity removed;
(iii) location of floor stock;
(iv) date and time; and
(v) signature or electronic signature of person making
the withdrawal;
(D) the medication order in the patient's chart may
substitute for the record required in subparagraph (C) of this paragraph,
provided the medication order meets all the requirements of subparagraph
(C) of this paragraph; and
(E) if a stored drug or device is returned to the pharmacy
from floor stock areas, a record shall be made by the authorized person
returning the drug or device. The record shall contain the following
information:
(i) drug name, strength, and dosage form, or device
name;
(ii) quantity returned;
(iii) previous floor stock location for the drug or
device;
(iv) date and time; and
(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;
Cont'd... |
