Oregon Bulletin
June 1, 2011
Rule
Caption: Adopt and amend rules regarding
administration of drugs, remote dispensing and compounding of drugs.
Adm.
Order No.: BP 3-2011
Filed with Sec. of State: 4-18-2011
Certified to be
Effective: 4-18-11
Notice Publication
Date: 2-1-2011
Rules Adopted: 855-019-0265, 855-041-0645
Rules Amended: 855-041-0600, 855-045-0220, 855-045-0240
Subject: The new rule in Division 19 regarding administration
of drugs by a pharmacist implements ORS 689.655 (OL 2009 Ch 326) and
establishes the conditions when a pharmacist may administer a drug. Permanent
rules in Division 41 regarding Remote Dispensing replace temporary rules
adopted June 2010 and specify situations and conditions for registration of a
facility where remote supervision of the dispensing process is permitted.
Compounding rules in Division 45 are revised to accommodate modern technologies
where computers can record verification, and there is no need for handwritten
initialing.
Rules Coordinator: Karen MacLean—(971) 673-0001
855-019-0265
Administration of Drugs
(1) In accordance with ORS 689.655, a pharmacist may
administer a drug or device as specified in this rule.
(2) A pharmacist who administers a drug or device must:
(a) Observe, monitor, report, and otherwise take
appropriate action regarding desired effect, side effect, interaction, and
contraindication associated with administering the drug or device; and
(b) Ensure a record is kept for three years of such
activities. This record shall include but is not limited to:
(A) Patient identifier;
(B) Drug or device and strength;
(C) Route and site of administration;
(D) Date and time of administration;
(E) Pharmacist identifier.
(3) The pharmacist must be acting:
(a) Under the direction of or pursuant to a lawful
prescription or order issued by a licensed practitioner acting within the scope
of the practitioner’s practice or;
(b) In accordance with a written protocol or
collaborative drug therapy agreement with a licensed practitioner.
(4) The pharmacist must be able to document that they
have received training on the drug or device to be administered and the route
of administration. Such training may include a program approved by the ACPE,
curriculum based programs from an ACPE-accredited college, state or local
health department programs, training by an appropriately qualified
practitioner, or programs approved by the Board.
(5) The pharmacist may administer a drug or device in
conjunction with training the patient or the patient’s caregiver how to
administer or self-administer the drug or device.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.655
Hist.: BP 3-2011, f. & cert.
ef. 4-18-11
855-041-0600
Definitions
(1) “Automated Pharmacy System” (APS) means a
mechanical system that performs operations or activities, including but not
limited to, those related to the storage, packaging, dispensing, or
distribution of medications, but not including compounding or administration,
and that collects, controls, and maintains all transaction information.
(2) “Remote Dispensing Facility” (RDF) means a facility
where drugs are prepared for administration and where requisite pharmacist
supervision is provided remotely as approved by the Board.
(3) “Remote Dispensing Machine” (RDM) means a component
of an Automated Pharmacy System that contains prepackaged drugs for dispensing.
(4) “Responsible Pharmacy” means the licensed pharmacy
that is responsible for the APS, and RDM.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 2-2005, f. 2-14-05,
cert. ef. 3-1-05; BP 9-2010(Temp), f. & cert. ef. 7-9-10 thru 12-24-10;
Administrative correction 1-25-11; BP 3-2011, f. & cert. ef. 4-18-11
855-041-0645
Remote Dispensing Facility (RDF)
(1) A pharmacy physically located in Oregon may make
written application to operate an RDF.
(2) At its discretion, the Board may approve an
application for registration as an RDF which includes the following:
(a) An operation plan;
(b) Policies and Procedures;
(c) A training plan;
(d) A quality assurance plan for ensuring that there is
a planned and systematic process for the monitoring and evaluation of the
quality and appropriateness of pharmacy services and for identifying and
resolving problems; and
(e) The fee specified in OAR 855-110-0007(14).
(3) Notwithstanding the definition of “supervision by a
pharmacist” in OAR 855-006-0005, supervision in an RDF may be accomplished by a
pharmacist via an audio-visual technology from the applying pharmacy.
(4) Notwithstanding rules in this division and in
Division 19, a Certified Pharmacy Technician who works in an RDF may have
access to the facility without the physical presence of a pharmacist, but may
only perform Board approved functions when under the supervision of a
pharmacist.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 3-2011, f. & cert.
ef. 4-18-11
855-045-0220
Personnel
(1) Personnel who prepare compounded pharmaceuticals,
both sterile and non-sterile, shall be provided with appropriate training
before they begin to prepare such products including for CSPs, training in the
theoretical principles and practical skills of aseptic manipulations.
(2) The pharmacist in charge (PIC) shall establish
pharmacy Policies and Procedures that contain protocols in accordance with the
guidelines in USP 797, for the initial training and testing of all personnel
and for annual retesting in aseptic manipulative skills for those personnel
involved in low and medium risk compounding.
(3) Personnel involved in high-risk compounding must be
retested in aseptic manipulative skills at least semi-annually.
(4) The PIC shall ensure that training protocols are
followed and records are kept for the training of all new personnel and for all
continuing education and periodic testing that is completed.
(5) The PIC is responsible for the procedures and the
overall operation of all activities within the pharmacy and must:
(a) Ensure all pharmacy personnel involved in preparing
compounded products are trained and have demonstrated skills commensurate with
the complexity of the procedures they are performing;
(b) Establish a procedure for verification by a
pharmacist of the preparation of each completed compounded product. This
verification shall be accomplished by a review of each compounded product that
includes but is not limited to:
(A) Ensuring that the drug, dose and dosage form
ordered are appropriate for the patient;
(B) Verifying that the correct drugs and components
were selected;
(C) Confirming that the calculation and quantity of each
drug and component is correct;
(D) Verifying the label is correct and where
appropriate contains all the information specified in OAR 855-041-0065 and
these rules.
(c) Document verification by the pharmacist responsible
for the review.
Stat. Auth.: ORS 689.205
Stats Implemented: ORS 689.155
Hist.: BP 2-2008, f. & cert.
ef. 2-20-08; BP 3-2011, f. & cert. ef. 4-18-11
855-045-0240
Sterile Parenteral Products
(1) In addition to complying with all the other rules
in this chapter of rules that are appropriate to their practice setting,
pharmacists compounding sterile parenteral products must comply with the
following specific rules.
(a) Establish, maintain and enforce written policies
and procedures associated with the pharmacy’s preparation and dispensing of
parenteral products. Policies and procedures shall be available for inspection
at the pharmacy. These policies and procedures shall include all requirements
of OAR 855-045-0230 as appropriate to the practice setting and:
(A) Requirements for compounding, labeling and storage
of the products;
(B) Requirements for administration of parenteral
therapy;
(C) Requirements for storage and maintenance of
equipment and supplies.
(b) Labeling: In addition to regular labeling
requirements, the label shall include:
(A) Rate of infusion, as appropriate;
(B) Beyond Use Date;
(C) Storage requirements or special conditions, if
applicable;
(D) Name, quantity and concentration of all ingredients
contained in the products, including primary solution;
(E) Initials of the pharmacist who verified the
accuracy of the completed product.
(c) Patient Care Services: Counseling shall be
available to the patient or patient’s agent concerning proper use of
parenterals and related supplies furnished by the pharmacy.
(2) In addition to complying with all the requirements
in section (1) of this rule, licensed pharmacy personnel preparing parenteral
admixtures as defined in OAR 855-045-0210 may:
(a) Prepare multiple source commercially available
premixed parenteral admixtures;
(b) Prepare single source premix parenteral admixtures
if the individual components of the premixed parenteral solution are
commercially available;
(c) Reassign a parenteral admixture to another patient
if the admixture does not exceed the documented BUD for that admixture, and the
parenteral admixture that was prepared and dispensed for a patient specific
order, and has been stored at all times under the control of a person trained
and knowledgeable in the storage and administration of drugs;
(d) In the case of a patient specific parenteral
admixture, the pharmacist does not need to comply with the worksheet and log
requirements in these rules provided that a quality assurance process is in
place to address drug recalls, and appropriate safeguards are in place.
Stat. Auth.: ORS 689.205
Stats Implemented: ORS 689.155
Hist.: PB 5-1987, f. & ef.
5-1-87; PB 12-1989, f. & cert. ef. 8-11-89; BP 7-2005, f. 12-14-05, cert.
ef. 12-15-05; Renumbered from 855-041-0063, BP 2-2008, f. & cert. ef.
2-20-08; BP 3-2011, f. & cert. ef. 4-18-11
Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2010.
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