856 IAC 1-28.1-9 - Emergency drug kits from Type III and Type VI pharmacies
Authority: IC 25-26-13-4
Affected: IC 25-26-13-17; IC 35-38
Sec. 9.
(a) Emergency
drug kits supplied by pharmacies with a Type III or Type VI permit shall be in
compliance with this section.
(b)
All drugs in the emergency kit shall be provided and owned by a single
supplying pharmacy.
(c) All drugs
in the emergency drug kit shall be selected and approved by a committee whose
membership includes, at a minimum, the following:
(1) The facility's consultant
pharmacist.
(2) A licensed
nurse.
(3) A physician (medical
doctor or doctor of osteopathy).
(4) The facility administrator.
(d) The selection process must
identify drugs and quantities thereof in the emergency drug kit.
(e) The lists of drugs and quantities
included in the emergency drug kit shall be reviewed as required periodically,
but no less often than yearly.
(f)
Labeling as follows:
(1) The exterior labeling
of the emergency drug kit as described in this subsection shall contain, at a
minimum, the following:
(A) Drug name (trade
name, generic name, or active ingredients).
(B) Drug strength or size, if any.
(C) Quantity included therein.
(D) Expiration date of the kit as defined in
this section.
(2) All
drugs contained in the emergency drug kit as described in this section shall be
labeled, at a minimum, with the following:
(A) Drug name (trade name, generic name, or
active ingredients).
(B) Drug
strength or size, if applicable.
(C) Name of the manufacturer, packer, or
distributor.
(D) Lot
number.
(E) Expiration
date.
(g) The
expiration date of the emergency drug kit, as required in subsection (f)(1)(D)
shall be the earliest date of expiration of any of the drugs included in the
kit at any time.
(h) All emergency
kits subject to this subsection:
(1) shall be
stored in a secure area, suitable for the prevention of unauthorized access to
or diversion of the drugs therein;
(2) if controlled substances, as defined in
IC 35-38, are stored in such a manner as to facilitate periodic reconciliation
by the facility nursing staff, that reconciliation shall be recorded in an
appropriate manner as determined by the committee described under this section;
and
(i) The nurse responsible for removing drugs
from an emergency drug kit shall record or cause to be recorded, in a manner
designated under subsection (h)(2), the following minimum information:
(1) Name of the patient.
(2) Name of the drug.
(3) Strength of the drug.
(4) Quantity removed.
(5) Date of removal.
(6) Time of removal.
(j) Removal of a controlled substance in
Schedule II pursuant to an oral authorization from a practitioner shall be
documented, and the nurse accepting such authorization is responsible for
compliance with
856 IAC 2-6-7 regarding
prescription requirements for controlled substances in Schedule II.
(k) Removal of a controlled substance in
Schedule III, IV, or V, pursuant to an oral authorization from a practitioner,
shall be documented, and the nurse accepting such authorization is responsible
for compliance with
856 IAC 2-6-12.
(l) Whenever an emergency kit is opened, for
any reason, the supplying pharmacy shall be notified in a timely manner, and
the pharmacy shall restock, if necessary, and reseal the kit promptly so as to
prevent risk of harm to patients of the facility.
Notes
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