| (i) Prescription drugs and devices only in sufficient
quantities for immediate therapeutic needs may be removed from the
institutional 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 patient;
(II) name of device or drug, strength, and dosage form;
(III) dose prescribed;
(IV) quantity taken;
(V) time and date; and
(VI) signature (first initial and last name or full
signature) or electronic signature of person making withdrawal;
(iv) The original or direct copy of the medication
order may substitute for such record, providing the medication order
meets all the requirements of clause (iii) of this subparagraph; and
(v) The pharmacist shall verify the withdrawal of drugs
from the pharmacy and perform a drug regimen review as specified in
subsection (g)(1)(B) of this section as soon as practical, but in
no event more than 72 hours from the time of such withdrawal.
(B) In facilities with a part-time or consultant pharmacist,
if a practitioner orders a drug for administration to a bona fide
patient of the facility 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 institutional
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 meet the same requirements as specified in subparagraph (A)(iii)
and (iv) of this paragraph;
(iv) The pharmacist shall verify the withdrawal of
drugs from the pharmacy after a reasonable interval, but in no event
may such interval exceed seven days; and
(v) The pharmacist shall perform a drug regimen review
as specified in subsection (g)(1)(B) of this section as follows:
(I) If the facility has an average daily inpatient
census of ten or less, the pharmacist shall perform the drug review
after a reasonable interval, but in no event may such interval exceed
seven (7) days; or
(II) If the facility has an average inpatient daily
census above ten, the pharmacist shall perform the drug review after
a reasonable interval, but in no event may such interval exceed 96
hours.
(vi) The average daily inpatient census shall be calculated
by hospitals annually immediately following the submission of the
hospital's Medicare Cost Report and the number used for purposes of
subparagraph (B)(v)(I) and (II) of this paragraph shall be the average
of the inpatient daily census in the report and the previous two reports
for a three year period.
(2) Floor stock. In facilities using a floor stock
method of drug distribution, the following is applicable:
(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; 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 (first initial and last name or full
signature) or electronic signature of person making the withdrawal.
(D) The pharmacist shall verify the withdrawal of drugs
from the pharmacy after a reasonable interval, but in no event may
such interval exceed seven days.
(3) Rural hospitals. In rural hospitals when a pharmacy
technician performs the duties listed in §291.73(e)(2)(D) of
this title, the following is applicable:
(A) the pharmacy technician shall make a record of
all drugs distributed from the pharmacy. The record shall be maintained
in the pharmacy for two years and contain the following information:
(i) name of patient or location where floor stock is
distributed;
(ii) name of device or drug, strength, and dosage form;
(iii) dose prescribed or ordered;
(iv) quantity distributed;
(v) time and date of the distribution; and
(vi) signature (first initial and last name or full
signature) or electronic signature of nurse or practitioner that verified
the actions of the pharmacy technician.
(B) The original or direct copy of the medication order
may substitute for the record specified in subparagraph (A) of this
paragraph, provided the medication order meets all the requirements
of subparagraph (A) of this paragraph.
(C) The pharmacist shall:
(i) verify and document the verification of all distributions
made from the pharmacy in the absence of a pharmacist as soon as practical,
but in no event more than seven (7) days from the time of such distribution;
(ii) perform a drug regimen review for all medication
orders as specified in subsection (g)(1)(B) of this section and document
such verification including any discrepancies noted by the pharmacist
as follows:
(I) If the facility has an average daily inpatient
census of ten or less, the pharmacist shall perform the drug review
as soon as practical, but in no event more than seven (7) days from
the time of such distribution; or
(II) If the facility has an average daily inpatient
census above ten, the pharmacist shall perform the drug review after
a reasonable interval, but in no event may such interval exceed 96
hours;
(iii) review any discrepancy noted by the pharmacist
with the pharmacy technician(s) and make any change in procedures
or processes necessary to prevent future problems; and
(iv) report any adverse events that have a potential
for harm to a patient to the appropriate committee of the hospital
that reviews adverse events.
(D) The average daily inpatient census shall be calculated
by hospitals annually immediately following the submission of the
hospital's Medicare Cost Report and the number used for purposes of
subparagraph (C)(ii)(I) and (II) of this paragraph shall be the average
of the inpatient daily census in the report and the previous two reports
for a three year period.
(f) Drugs.
(1) Procurement, preparation and storage.
(A) The pharmacist-in-charge shall have the responsibility
for the procurement and storage of drugs, but may receive input from
other appropriate staff of the facility, relative to such responsibility.
(B) The pharmacist-in-charge shall have the responsibility
for determining specifications of all drugs procured by the facility.
(C) Institutional pharmacies may not sell, purchase,
trade or possess prescription drug samples, unless the pharmacy meets
the requirements as specified in §291.16 of this title (relating
to Samples).
(D) All drugs shall be stored at the proper temperatures,
as defined in the USP/NF and in §291.15 of this title (relating
to Storage of Drugs).
(E) Any drug bearing an expiration date may not be
distributed beyond the expiration date of the drug.
(F) Outdated and other unusable drugs shall be removed
from stock and shall be quarantined together until such drugs are
disposed of properly.
(2) Formulary.
(A) A formulary shall be developed by the facility
committee performing the pharmacy and therapeutics function for the
facility. For the purpose of this section, a formulary is a compilation
of pharmaceuticals that reflects the current clinical judgment of
a facility's medical staff.
(B) The pharmacist-in-charge or pharmacist designated
by the pharmacist-in-charge shall be a full voting member of the committee
performing the pharmacy and therapeutics function for the facility,
when such committee is performing the pharmacy and therapeutics function.
(C) A practitioner may grant approval for pharmacists
at the facility to interchange, in accordance with the facility's
formulary, for the prescribed drugs on the practitioner's medication
orders provided:
(i) the pharmacy and therapeutics committee has developed
a formulary;
(ii) the formulary has been approved by the medical
staff committee of the facility;
Cont'd... |
