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Oregon Bulletin

June 1, 2011

 

Board of Pharmacy
Chapter 855

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.

2.) Copyright 2011 Oregon Secretary of State: Terms and Conditions of Use

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