As used in OAR chapter 855:
(1) “Board” means the Oregon Board of Pharmacy unless otherwise specified or required by the context.
(2) "Certified Pharmacy Technician" means a person licensed by the State Board of Pharmacy who assists the pharmacist in the practice of pharmacy pursuant to rules of the Board and has completed the specialized education program pursuant to OAR 855-025-0005. Persons used solely for clerical duties, such as recordkeeping, cashiering, bookkeeping and delivery of medications released by the pharmacist are not considered pharmacy technicians.
(3) “Clinical Pharmacy Agreement” means an agreement between a pharmacist or pharmacy and a health care organization or a physician that permits the pharmacist to engage in the practice of clinical pharmacy for the benefit of the patients of the health care organization or physician.
(4) "Collaborative Drug Therapy Management" means the participation by a pharmacist in the management of drug therapy pursuant to a written protocol that includes information specific to the dosage, frequency, duration and route of administration of the drug, authorized by a practitioner and initiated upon a prescription order for an individual patient and:
(a) Is agreed to by one pharmacist and one practitioner; or
(b) Is agreed to by one or more pharmacists at a single pharmacy registered by the board and one or more practitioners in a single organized medical group, such as a hospital medical staff, clinic or group practice, including but not limited to organized medical groups using a pharmacy and therapeutics committee.
(5) "Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or device:
(a) As the result of a practitioner’s prescription drug order, or initiative based on the relationship between the practitioner, the pharmacist and the patient, in the course of professional practice; or
(b) For the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing; or
(c) The preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns; or
(d) As a component of a Shared Pharmacy Service agreement as defined in section (21) of this rule.
(6) "Confidential Information" means any patient information obtained by a pharmacist or pharmacy.
(7) "Consulting Pharmacist" means a pharmacist that provides a consulting service regarding a patient medication, therapy management, drug storage and management, security, education, or any other pharmaceutical service.
(8) The "Container" is the device that holds the drug and that is or may be in direct contact with the drug.
(9) "Dispensing or Dispense" means the preparation and delivery of a prescription drug pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug.
(10) "Interpretation and evaluation of prescription orders" means the review of the order for therapeutic and legal correctness. Therapeutic review includes identification of the prescription drug ordered, its applicability and its relationship to the other known medications used by the patient and determination of whether or not the dose and time interval of administration are within accepted limits of safety. The legal review for correctness of the prescription order includes a determination that the order is valid and has not been altered, is not a forgery, is prescribed for a legitimate medical purpose, contains all information required by federal and state law, and is within the practitioner's scope of practice.
(11) "Labeling" means the process of preparing and affixing of a label to any drug container exclusive, however, of the labeling by a manufacturer, packer or distributor of a non-prescription drug or commercially packaged legend drug or device.
(12) "Monitoring of therapeutic response or adverse effect of drug therapy" means the follow up of the therapeutic or adverse effect of medication upon a patient, including direct consultation with the patient or his agent and review of patient records, as to result and side effect, and the analysis of possible interactions with other medications that may be in the medication regimen of the patient. This section shall not be construed to prohibit monitoring by practitioners or their agents.
(13) "Medication Therapy Management (MTM)" means a distinct service or group of services that is intended to optimize therapeutic outcomes for individual patients. Medication Therapy Management services are independent of, but can occur in conjunction with, the provision of a medication product.
(14) "Nationally Certified Exam" means an exam that is approved by the Board which demonstrates successful completion of a Specialized Education Program. The exam must be reliable, psychometrically sound, legally defensible and valid.
(15) "Non-legend drug" means a drug which does not require dispensing by prescription and which is not restricted to use by practitioners only.
(16) "Offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of pharmacy" means, among other things:
(a) The creation and retention of accurate and complete patient records;
(b) Assuming authority and responsibility for product selection of drugs and devices;
(c) Developing and maintaining a safe practice setting for the pharmacist, for pharmacy staff and for the general public;
(d) Maintaining confidentiality of patient information.
(17) "Oral Counseling" means an oral communication process between a pharmacist and a patient or a patient’s agent in which the pharmacist obtains information from the patient (or agent) and the patient's pharmacy records, assesses that information and provides the patient (or agent) with professional advice regarding the safe and effective use of the prescription drug for the purpose of assuring therapeutic appropriateness.
(18) Participation in Drug Selection and Drug Utilization Review:
(a) "Participation in drug selection" means the consultation with the practitioner in the selection of the best possible drug for a particular patient.
(b) "Drug utilization review" means evaluating prescription drug order in light of the information currently provided to the pharmacist by the patient or the patient's agent and in light of the information contained in the patient's record for the purpose of promoting therapeutic appropriateness by identifying potential problems and consulting with the prescriber, when appropriate. Problems subject to identification during drug utilization review include, but are not limited to:
(A) Over-utilization or under-utilization;
(B) Therapeutic duplication;
(C) Drug-disease contraindications;
(D) Drug-drug interactions;
(E) Incorrect drug dosage;
(F) Incorrect duration of treatment;
(G) Drug-allergy interactions; and
(H) Clinical drug abuse or misuse.
(19) "Pharmaceutical Care" means the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life. These outcomes include:
(a) Cure of a disease;
(b) Elimination or reduction of a patient's symptomatology;
(c) Arrest or slowing of a disease process; or
(d) Prevention of a disease or symptomatology.
(20) "Pharmacy Technician" means a person licensed by the State Board of Pharmacy who assists the pharmacist in the practice of pharmacy pursuant to rules of the Board but has not completed the specialized education program pursuant to OAR 855-025-0012.
(21) “Practice of clinical pharmacy” means:
(a) The health science discipline in which, in conjunction with the patient’s other practitioners, a pharmacist provides patient care to optimize medication therapy and to promote disease prevention and the patient’s health and wellness;
(b) The provision of patient care services, including but not limited to post-diagnostic disease state management services; and
(c) The practice of pharmacy by a pharmacist pursuant to a clinical pharmacy agreement.
(22) “Practice of pharmacy” is as defined in ORS 689.005.
(23) "Prescription released by the pharmacist” means, a prescription which has been reviewed by the pharmacist that does not require further pharmacist intervention such as reconstitution or counseling.
(24) “Prohibited conduct” means conduct by a licensee that:
(a) Constitutes a criminal act against a patient or client; or
(b) Constitutes a criminal act that creates a risk of harm to a patient or client.
(25) "Proper and safe storage of drugs and devices and maintenance of proper records therefore" means housing drugs and devices under conditions and circumstances that:
(a) Assure retention of their purity and potency;
(b) Avoid confusion due to similarity of appearance, packaging, labeling or for any other reason;
(c) Assure security and minimize the risk of their loss through accident or theft;
(d) Accurately account for and record their receipt, retention, dispensing, distribution or destruction;
(e) Protect the health, safety and welfare of the pharmacist, pharmacy staff and the general public from harmful exposure to hazardous substances.
(26) “Quality Assurance Plan” is a written set of procedures to ensure that a pharmacy has a planned and systematic process for the monitoring and evaluation of the quality and appropriateness of pharmacy services and for identifying and resolving problems.
(27) "Responsibility for advising, when necessary or when regulated, of therapeutic values, content, hazards and use of drugs and devices" means advice directly to the patient, either verbally or in writing as required by these rules or federal regulation, of the possible therapeutic response to the medication, the names of the chemicals in the medication, the possible side effects of major importance, and the methods of use or administration of a medication.
(28) "Shared Pharmacy Service" means a written agreement, that has been approved in writing by the board, that exists for the processing by a pharmacy of a request from another pharmacy or a practitioner licensed to prescribe the drug, to fill or refill a prescription or a drug order, or to perform processing functions including but not limited to:
(b) Drug utilization review;
(c) Claims adjudication;
(d) Refill authorizations;
(e) Compounding by a pharmacy located in Oregon for a practitioner or dispenser located in Oregon for Oregon outlets and practitioners located in Oregon only; and
(f) Therapeutic interventions.
(29) "Specialized Education Program" means;
(a) A program providing education for persons desiring licensure as pharmacy technicians that is approved by the board and offered by an accredited college or university that grants a two-year degree upon successful completion of the program; or
(b) A structured program approved by the board and designed to educate pharmacy technicians in one or more specific issues of patient health and safety that is offered by:
(A) An organization recognized by the board as representing pharmacists or pharmacy technicians;
(B) An employer recognized by the board as representing pharmacists or pharmacy technicians; or
(C) A trade association recognized by the board as representing pharmacies.
(30) "Supervision by a pharmacist" means being stationed within the same work area as the pharmacy technician or certified pharmacy technician being supervised, coupled with the ability to control and be responsible for the pharmacy technician or certified pharmacy technician's action.
(31) "Therapeutic substitution" means the act of dispensing a drug product with a different chemical structure for the drug product prescribed under circumstances where the prescriber has not given clear and conscious direction for substitution of the particular drug for the one which may later be ordered.
(32) "Verification" means the confirmation by the pharmacist of the correctness, exactness, accuracy and completeness of the acts, tasks, or functions performed by an intern or a pharmacy technician or a certified pharmacy technician.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.005, 689.151, 689.155, 689.305, 689.405 & 689.455, 689.645
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1984, f. & ef. 4-16-84; PB 2-1988, f. & cert. ef. 5-3-88; PB 2-1989, f. & cert. ef. 1-30-89; PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1994, f. & cert. ef. 2-2-94; BP 4-1998, f. & cert. ef. 8-14-98; BP 1-2006, f. & cert. ef. 6-9-06; BP 12-2006, f. & cert. ef. 12-19-06; BP 2-2008, f. & cert. ef. 2-20-08; BP 6-2010, f. & cert. ef. 6-29-10; BP 3-2012, f. & cert. ef. 6-19-12; BP 8-2015, f. & cert. ef. 12-23-15; BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
(1) Electronically Transmitted Prescription:
(a) Where used in this chapter, Electronically Transmitted Prescription (ETP) means a prescription for a drug or medical device issued by a practitioner, who is licensed and authorized to prescribe pursuant to the laws of this state and is acting within the scope of his or her practice, which has been transmitted by an electronic means that may include but is not limited to:
(A) Transmission by facsimile or hand held digital electronic device to a computer or facsimile;
(B) Transmission from a computer to another computer;
(C) Transmission by facsimile to computer; or
(D) Transmission from a computer to facsimile.
(b) ETP does not include an oral prescription that has been reduced to writing by a pharmacist pursuant to OAR 855-041-0085 and does not include prescriptions, or drug or device orders written for inpatient use in a hospital.
(c) For an ETP to be valid, it must contain the name and immediate contact information of the prescriber, and be electronically encrypted or in some manner protected by up-to-date technology from unauthorized access, alteration or use.
(2) Tamper-resistant Prescription:
(a) Where used in this chapter, Tamper-resistant Prescription means a form for the purpose of issuing a hand written or typed prescription, intended to be manually delivered to a pharmacy, which has been developed, produced and formatted to ensure security, integrity and authenticity using currently accepted technologies.
(b) Formatted features may include but are not limited to characteristics such as:
(A) The word "void" appears when photocopies are attempted;
(B) Background ink which reveals attempted alterations;
(C) Heat sensitive ink that changes colors;
(D) Penetrating ink to prevent chemical alterations;
(E) A watermark which cannot be photocopied;
(F) Coin reactive ink that reveals word when rubbed with a coin;
(G) Sequential numbering.
Stat. Auth.: 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 2-2007(Temp), f. & cert. ef. 8-27-07 thru 2-18-08; BP 1-2008, f. & cert. ef. 2-5-08
Unprofessional Conduct Defined
"Unprofessional conduct" means conduct unbecoming of a licensee or detrimental to the best interests of the public, including conduct contrary to recognized standards of ethics of pharmacy or conduct that endangers the health, safety or welfare of a patient or client. Unprofessional conduct includes but is not limited to:
(a) Fraud or misrepresentation in dealings relating to pharmacy practice with:
(A) Customers, patients or the public;
(B) Practitioners authorized to prescribe drugs, medications or devices;
(C) Insurance companies;
(D) Wholesalers, manufactures or distributors of drugs, medications or devices;
(E) Health care facilities;
(F) Government agencies; or
(G) Drug outlets.
(b) Illegal use of drugs, medications or devices without a practitioner's prescription, or otherwise contrary to federal or state law or regulation;
(c) Any use of intoxicants, drugs or controlled substances that endangers or could endanger the licensee or others;
(d) Theft of drugs, medications or devices, or theft of any other property or services under circumstances which bear a demonstrable relationship to the practice of pharmacy;
(e) Dispensing a drug, medication or device where the pharmacist knows or should know due to the apparent circumstances that the purported prescription is bogus or that the prescription is issued for other than a legitimate medical purpose, including circumstances such as:
(A) Type of drug prescribed;
(B) Amount prescribed; or
(C) When prescribed out of context of dose.
(f) Any act or practice relating to the practice of pharmacy that is prohibited by state or federal law or regulation;
(g) The disclosure of confidential information in violation of Board rule;
(h) Engaging in collaborative drug therapy management in violation of ORS Chapter 689 and the rules of the Board;
(i) Authorizing or permitting any person to practice pharmacy in violation of the Oregon Pharmacy Act or the rules of the Board;
(j) Any conduct or practice by a licensee or registrant which the Board determines is contrary to accepted standards of practice; or
(k) Failure to cooperate with the Board pursuant to OAR 855-001-0035.
Stat. Auth.: 689.205
Stats. Implemented: ORS 689.005 and 689.155
Hist.: BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
State Archives • 800 Summer St. NE • Salem, OR 97310