Iowa Admin. Code r. 657-22.7 - Emergency/first dose drug supply
In any facility registered with the
(1)
Emergency/first dose drug supplies. Contents of the
emergency/first dose drug supply shall be provided by a primary provider
pharmacy designated by the facility, and the drug supply shall be available to
meet the needs of all patients of the facility, without penalty or
discrimination. If the primary provider pharmacy does not supply or is unable
to supply all drugs and products needed for the emergency care of facility
patients, a second provider pharmacy may provide an emergency/first dose drug
supply consisting only of drugs and products not stocked or available from the
primary provider pharmacy including, but not limited to, parenteral or
compounded drug products. The provider pharmacies shall be properly registered
with the federal Drug Enforcement Administration (DEA ) and the board and shall
be currently licensed by the board . The provider pharmacist or pharmacists, the
consultant pharmacist , the director of nursing of the facility, and the medical
director of the facility, or their respective designees, shall jointly
determine and prepare a list of drugs necessary for prompt use in patient care
that will be available in each emergency/first dose drug supply. Drugs shall be
listed by identity and quantity, shall be limited to drugs necessary to meet
the emergency needs of the patients served, and shall be periodically reviewed
pursuant to policy. Careful patient planning should be a cooperative effort
between the pharmacies and the facility to make drugs available, and
emergency/first dose drug supplies shall only be used for emergency or
unanticipated needs. The intent of the emergency/first dose drug supply is not
to relieve a pharmacy of the responsibility for timely provision of a patient's
routine drug needs and is not intended to relieve any provider pharmacy from
the provider pharmacy 's responsibility to provide 24-hour services to facility
patients; the intent is to ensure that a supply of drugs is available to each
patient in case of urgent need. The drugs in emergency/first dose drug supplies
are the responsibility of the respective provider pharmacy and, therefore,
shall not be used or altered in any way except as provided in this
rule.
(2)
Storage.
The emergency/first dose drug supply shall be stored in an area suitable to
prevent unauthorized access and to ensure a proper environment for preservation
of drugs contained therein as required in official compendia. The provider
pharmacist is responsible for establishing procedures to maintain the security
of the emergency/first dose drug supply.
(3)
Labeling
-exterior. The exterior of an emergency/first dose drug supply
shall be labeled clearly and shall unmistakably indicate that it is an
emergency/first dose drug supply. Such label shall also contain a listing of
the name, strength, and quantity of each drug contained therein and an
expiration date of the supply based upon the earliest expiration date of any
drug contained in the supply.
(4)
Labeling -interior. All drugs contained in
the emergency/first dose drug supply shall be labeled in accordance with
subrule 22.3(2) or 22.1(3), as appropriate.
(5)
Removal of drugs. A drug
shall be removed from the emergency/first dose drug supply only pursuant to a
valid prescription order and by authorized personnel or by the provider
pharmacist . The patient's dispensing pharmacy shall be notified, prior to the
administration of a second dose, that a drug was administered to a specific
patient. Upon notification, the dispensing pharmacist shall perform drug use
review to assess the appropriateness of the drug therapy for the patient. If
the emergency/first dose drug supply contains a multidose package of a drug
product that is removed from the supply for administration of one or more doses
of the product to a patient and if following that administration the package
contains one or more additional doses of the drug product and if the prescriber
authorizes continuation of the drug product for that patient, the provider
pharmacy shall complete either of the following processes.
a. Prepare and affix to the multidose package
a label in compliance with rule
657-23.11
(124,155A). The label shall be prepared and affixed to the package within 24
hours of administration of the emergency dose or doses.
b. Dispense, pursuant to a valid prescription
order and in compliance with rule
657-23.11
(124,155A), an appropriately labeled supply of the drug for the patient. The
new prescription shall be delivered to the facility within 24 hours of
administration of the emergency dose or doses.
(6)
Notifications. Whenever
an emergency/first dose drug supply is opened or has expired, the provider
pharmacy shall be notified and the pharmacist shall be responsible for
replacing the drug within 72 hours to prevent risk of harm to patients.
Pursuant to rule
657-8.3
(155A), established policies and procedures shall address notification, record
keeping, and documentation procedures for use of the supply.
(7)
Procedures.
a. The pharmacy, in communication with the
director of nursing of the facility and the medical director of the facility,
or their respective designees, and as provided in rule
657-8.3
(155A), shall have written policies and procedures to ensure compliance with
this rule.
b. The provider pharmacy
shall keep a record of each prescription drug stored in the emergency/first
dose drug supply and the number of doses provided.
c. The facility shall keep a complete record
of the use of prescription drugs from the emergency/first dose drug supply for
two years following such use. The record shall include the patient's name, the
date of use, the name of the drug used, the strength of the drug, the number of
doses used, the name of the prescriber authorizing the administration, and the
initials or unique identification of the person administering the
dose.
d. The drugs maintained in
the emergency/first dose drug supply shall be available for the emergency
pharmaceutical care of all facility patients, without penalty or
discrimination. If a service charge is assessed for the administration of a
drug from the emergency/first dose drug supply, the same reasonable service
charge shall be assessed to each patient to whom a drug from the
emergency/first dose drug supply is administered, regardless of the patient's
choice of pharmacy for pharmaceutical services.
This rule is intended to implement Iowa Code sections 124.301, 124.306, 155A.13, and 155A.15.
Notes
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