Or. Admin. Code § 855-041-6410 - Emergency Department Distribution
(1) A practitioner
or associate practitioner with prescriptive authority in Oregon who is a member
of the hospital's medical staff may dispense an emergency supply of drugs to a
patient examined by them or by an associate practitioner subject to the
following requirements:
(a) The prescriber
must offer the patient the option of being provided a prescription that may be
filled at the pharmacy of the patient's choice;
(b) During consultation with the patient or
the patient's caregiver, the prescriber must clearly explain the appropriate
use of the drug supplied and the need to have a prescription for any additional
supply of the drug filled at a pharmacy of the patient's choice;
(c) The patient must be given instructions on
the use and precautions for taking the drug;
(d) Except as described in SB 450 (2023), the
drug is in a manufacturer's unit-of-use container, such as an inhaler, or
hospital pre-pack that has been labeled by the pharmacy with:
(A) Name of drug, strength, and number of
units. When a generic name is used, the label must also contain the identifier
of the manufacturer or distributor;
(B) Accessory cautionary information as
required for patient safety;
(C)
Product identification label if the drug is not in unit-of-use
packaging;
(D) An expiration date
after which the patient should not use the drug; and
(E) Name, address and phone number of the
hospital pharmacy.
(e)
Except as described in SB 450 (2023), the following information must be added
to the drug container by the practitioner or nurse before dispensing to the
patient:
(A) Name of patient;
(B) Directions for use by the
patient;
(C) Date of
issue;
(D) Unique identifying
number as determined by policy and procedure;
(E) Name of prescribing practitioner;
and
(F) Initials of the dispensing
nurse or practitioner.
(f) A prescription or record of the
distribution must be completed by the practitioner or nurse. This record must
contain:
(A) Name of patient;
(B) Date of issuance;
(C) Drug name and strength
distributed;
(D) Units
issued;
(E) Name of
practitioner;
(F) Initials of the
dispensing nurse or practitioner; and
(G) Instructions given to the patient as
labeled.
(g) Any
additional information required by state and federal laws and regulations for
the distribution of a drug to an outpatient;
(h) The record must be reviewed and
documented by a pharmacist for accuracy and completeness. The pharmacist must
review the record of dispensing of drugs within 24 hours. However, if the
pharmacy is closed, records shall be reviewed during the first day the pharmacy
is open but not to exceed 72 hours following the dispensing; and
(i) Errors and discrepancies will be included
in hospital and pharmacy QA review process and available to the
board.
(2) A controlled
substance may only be distributed or dispensed to an outpatient by the
examining practitioner after the patient has been examined by the practitioner
and a legitimate medical purpose for a controlled substance has been
determined. Distribution of a controlled substance must comply with all
applicable state and federal laws and regulations.
(3) The CPO or PIC and appropriate hospital
committee will establish a limited selection and quantity of drugs to be
included in the Emergency Department formulary and the amount contained in each
pre-pack that may be distributed to meet only the acute care needs of a
patient; for example, an emergency supply of drugs. The amount dispensed may
not exceed a 48 hour supply except for:
(a) A
drug in the manufacturer's unit-of-use packaging such as an inhalant or a
topical drug;
(b) A full course of
therapy that may be dispensed if in the professional judgment of the pharmacist
or practitioner this would be in the patient's best interest such as an
antibiotic;
(4) Any
additional preparation for use of the medication must be completed prior to
discharge; for example, reconstituting antibiotics;
(5) For the purpose of this rule an Automated
Dispensing Machine (ADM) is a machine or contrivance which will prepare a
completed and labeled prescription which is ready for dispensing to the patient
or patient's representative.
(6) An
Automated Dispensing Machine; may only be located within the Emergency
Department in a secure environment that has no direct public access, and when
used, must be part of the discharge procedure;
(7) When the patient or patient's
representative receives the prescription from an ADM;
(a) A registered nurse or practitioner or
pharmacist must be present at the time of dispensing; and
(b) A registered nurse or practitioner or
pharmacist will grant access to the ADM for the release of the drugs to be
dispensed using a password protected or biometric access; and
(c) The patient or patient's representative
will obtain the drug using a specific patient access code.
(8) Only a pharmacy technician, certified
pharmacy technician, intern or pharmacist may access the drug supply in the
ADM.
(9) The CPO or PIC will
establish policies and procedures for use of the ADM including, but not limited
to emergency access and down time procedures for the ADM.
(10) Upon written request, the board may
waive any of the requirements of this rule if a waiver will further public
health or safety. A waiver granted under this section must only be effective
when it is issued in writing and will be time limited.
(11) Nothing in this rule is intended to
restrict or conflict with HB 2395 (2023), SB 450 (2023), SB 1043
(2023).
Notes
Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.505, 2023 HB 2395, 2023 SB 450 & 2023 SB 1043
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