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The Oregon Administrative Rules contain OARs filed through August 15, 2014
 
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BOARD OF PHARMACY

 

DIVISION 19

LICENSING OF PHARMACISTS

855-019-0100

Application

(1) These rules apply to any pharmacist who is licensed to practice pharmacy in Oregon including any pharmacist located in another state who is consulting, or providing any other pharmacist service, for a patient, pharmacy or healthcare facility in Oregon.

(2) Where so indicated, these rules also apply to an intern who is licensed in Oregon.

(3) Any pharmacist who engages in the practice of pharmacy in Oregon must be licensed by the Board in accordance with the following rules.

(4) A pharmacist who is located in another state and who engages in the practice of pharmacy for a patient, drug outlet or healthcare facility in Oregon, must be licensed by the Board in accordance with the following rules, except that a pharmacist working in an out-of-state pharmacy, who only performs the professional tasks of interpretation, evaluation, DUR, counseling and verification associated with their dispensing of a drug to a patient in Oregon, is not required to be licensed by the Board unless they are the pharmacist-in-charge (PIC).

(5) The Board may waive any requirement of this rule if, in the Board's judgment, a waiver will further public health or safety. A waiver granted under this section shall only be effective when issued in writing.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155, 689.255
Hist.: BP 2-2008, f. & cert. ef. 2-20-08; BP 6-2010, f. & cert. ef. 6-29-10

855-019-0110

Definitions

In this Division of Rules:

(1) "Collaborative Drug Therapy Management (CDTM)" has the same meaning as defined in OAR 855-006-0005.

(2) "Counseling" means an oral or other appropriate communication process between a pharmacist and a patient or a patient's agent in which the pharmacist obtains information from the patient or patient's agent, and, where appropriate, the patient's pharmacy records, assesses that information and provides the patient or patient's agent with professional advice regarding the safe and effective use of the drug or device for the purpose of assuring therapeutic appropriateness.

(3) "Drug Regimen Review (DRR)" means the process conducted by a pharmacist who is consulting for a long-term-care facility or other institution, either prior to dispensing or at a later time, with the goal of ensuring that optimal patient outcomes are achieved from the drug therapy.

(4) "Drug Utilization Review (DUR)" has the same meaning as defined in OAR 855-006-0005.

(5) "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.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155
Hist.: BP 2-2008, f. & cert. ef. 2-20-08

Licensing

855-019-0120

Licensure

Before licensure as a pharmacist, an applicant must meet the following requirements:

(1) Provide evidence from a school or college of pharmacy approved by the Board that they have successfully completed all the requirements for graduation and, starting with the graduating class of 2011, including not less than 1440 hours of School-based Rotational Internships as that term is defined in OAR 855-031-0005, and that a degree will be conferred;

(2) Pass the North American Pharmacist Licensure Examination (NAPLEX) exam with a score of not less than 75. This score shall remain valid for only one year unless the Board grants an extension. A candidate who does not attain this score may retake the exam after a minimum of 91 days except that a candidate who has failed the exam three times must wait at least one year before retaking the exam;

(3) Pass the Multistate Pharmacy Jurisprudence Examination (MPJE) exam with a score of not less than 75. The applicant may not take the MJPE until they have graduated from a school or college of pharmacy approved by the Board. A candidate who does not attain this score may retake the exam after a minimum of 30 days except that a candidate who has failed the exam three times must wait at least one year before retaking the exam. The MJPE score shall be valid for 6 months unless extended by the Board;

(4) Submit a completed application form that may be obtained from the Board office, and pay the fee specified in Division 110 of this chapter of rules.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 1-1981(Temp), f. & ef. 4-1-81; 1PB 2-1981, f. & ef. 8-20-81; 1PB 3-1985, f. & ef. 12-2-85; PB 3-1991, f. & cert. ef. 9-19-91; PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1994, f. & cert. ef. 2-2-94; PB 1-1996, f. & cert. ef. 4-5-96; BP 1-2002, f. & cert. ef. 1-8-02; Renumbered from 855-019-0005, BP 2-2008, f. & cert. ef. 2-20-08; BP 3-2010, f. 4-29-10, cert. ef. 4-30-10; BP 4-2011, f. 6-24-11, cert. ef. 7-1-11

855-019-0125

Coaching from Board and Staff

No member or employee of the Board shall discuss the contents of an examination, its preparation or use with any candidate or other person. No member or employee of the Board shall coach a candidate or any other person on materials that may be used in the examination nor shall they accept any fees for any act of assistance that would bear on the examination.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; BP 1-2002, f. & cert. ef. 1-8-02; Renumbered from 855-019-0010, BP 2-2008, f. & cert. ef. 2-20-08

855-019-0130

Licensure by Reciprocity

(1) An applicant for licensure as a pharmacist by reciprocity must meet the requirements of ORS 689.265 and the following requirements:

(a) Be a graduate of a school or college of pharmacy approved by the Board;

(b) Have passed the NAPLEX or equivalent examination with a score of not less than 75;

(c) Have passed the MPJE with a score of not less than 75;

(d) Be licensed and in good standing in the state from which the applicant bases the reciprocity application;

(e) Have either:

(A) Been engaged in the practice of pharmacy for period of at least one year including a minimum of 1440 hours of work experience as a licensed pharmacist. Evidence supporting this work experience shall be provided at time of application; or

(B) Met the internship requirements of this state within the one-year period immediately before the date of this application. Evidence from the school or college of pharmacy supporting this internship shall be provided at time of application.

(2) Licensure as a pharmacist in another state precludes licensure to practice as an intern in the State of Oregon, except an applicant that has been accepted into an Oregon pharmacy residency program or for licensure by examination or by reciprocity who must acquire internship hours to become eligible for licensure, and then only until the required hours have been acquired.

(3) An applicant who has obtained their professional degree outside the United States is not eligible for licensure by reciprocity until they have met the requirements of OAR 855-019-0150.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151 & 689.265
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 2-1981, f. & ef. 8-20-81; 1PB 1-1984, f. & ef. 2-16-84; PB 1-1989, f. & cert. ef. 1-3-89; PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1996, f. & cert. ef. 4-5-96; BP 1-2002, f. & cert. ef. 1-8-02; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; Renumbered from 855-019-0015 & 855-019-0030, BP 2-2008, f. & cert. ef. 2-20-08; BP 3-2010, f. 4-29-10, cert. ef. 4-30-10; BP 6-2014(Temp), f. & cert. ef. 4-25-14 thru 10-22-14

855-019-0140

NAPLEX Score Transfer

(1) An applicant for score transfer must be a graduate of a school or college of pharmacy approved by the Board and must have passed the NAPLEX or equivalent examination with a score of at least 75.

(2) Prior to taking the NAPLEX examination for their initial state of licensure, an applicant must have requested the National Association of Boards of Pharmacy to score transfer their NAPLEX score to Oregon.

(3) An applicant must provide the following documentation:

(a) Oregon Score Transfer Application;

(b) A passport regulation photograph;

(c) A copy of a birth certificate, US passport or naturalization documents, or a foreign passport endorsed with a US visa permitting full time employment;

(d) Evidence of successful completion of all graduation requirements from a school or college of pharmacy approved by the Board.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.265
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; BP 1-2002, f. & cert. ef. 1-8-02; Renumbered from 855-019-0025, BP 2-2008, f. & cert. ef. 2-20-08

855-019-0150

Foreign Pharmacy Graduates

(1) Foreign Pharmacy Graduates applying for licensure in Oregon must meet the following requirements:

(a) Provide a copy of a valid visa permitting full time employment;

(b) Provide the original certificate issued by the NABP Foreign Pharmacy Graduate Examination Committee (FPGEC); and

(c) Pass the North American Pharmacist Licensure Examination (NAPLEX) exam with a score of not less than 75. A candidate who does not attain this score may retake the exam after a minimum of 91 days. This score shall only be valid for one year unless the Board grants an extension;

(d) After having completed the required number of intern hours, pass the MPJE with a score of not less than 75. A candidate who does not attain this score may retake the exam after a minimum of 30 days. The MPJE score shall only be valid for 6 months unless extended by the Board.

(2) An applicant must complete 1440 hours in pharmacy practice as an intern that must be certified to the Board by the preceptors.

(3) An applicant may not count internship hours or practice as a pharmacist completed outside the United States toward Oregon's internship requirement.

(4) An applicant may not count internship hours or practice as a pharmacist that is completed before passing the Foreign Pharmacy Graduate Equivalency Examination (FPGEE), and either the TOEFL with TSE, or TOEFL (IBT) exams toward Oregon's internship requirement.

(5) The Board may waive any requirement of this rule if a waiver will further public health or safety. A waiver granted under this section shall only be effective when it is issued in writing.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151 & 689.255
Hist.: BP 2-2008, f. & cert. ef. 2-20-08; BP 3-2010, f. 4-29-10, cert. ef. 4-30-10; BP 3-2014(Temp), f. 2-27-14, cert. ef. 2-28-14 thru 8-27-14; BP 7-2014, f. & cert. ef. 6-18-14

855-019-0160

Nuclear Pharmacists

In order to qualify under these rules as a nuclear pharmacist, a pharmacist shall:

(1) Meet minimal standards of training and experience in the handling of radioactive materials in accordance with the requirements of the Radiation Protection Services of the Department of Human Services; and

(2) Be a pharmacist licensed to practice in Oregon; and

(3) Submit to the Board of Pharmacy either:

(a) Evidence of current certification in nuclear pharmacy by the Board of Pharmaceutical Specialties; or

(b) Evidence that they meet both the following:

(A) Certification of a minimum of six month on-the-job training under the supervision of a qualified nuclear pharmacist in a nuclear pharmacy providing radiopharmaceutical services; and

(B) Certification of completion of a nuclear pharmacy training program in a college of pharmacy or a nuclear pharmacy training program approved by the Board.

(4) Receive a letter of notification from the Board that the evidence submitted by the pharmacist meets the above requirements and has been accepted by the Board.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151
Hist.: PB 7-1987, f. & ef. 7-8-87; PB 1-1994, f. & cert. ef. 2-2-94: Renumbered from 855-042-0020, BP 2-2008, f. & cert. ef. 2-20-08

855-019-0170

Reinstatement of License

(1) A pharmacist who fails to renew their license by the deadline may reinstate their license as follows:

(a) By payment of the annual license fees and delinquency fees for all years during which the license was lapsed and for the current year; and

(b) By providing certification of completion of the continuing education requirement for all years in which the license was lapsed; and

(c) If their license has been lapsed for more than one year, pass the MPJE with a score of not less than 75.

(2) A pharmacist in good standing who retired from the practice of pharmacy after having been licensed for not less than 20 years need only pay the annual license fees for the year in which they seek a license, however they must provide certification of completion of continuing education for all years since their retirement and pass the MPJE with a score of not less than 75.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.275
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 2-1981, f. & ef. 8-20-81; BP 1-2002, f. & cert. ef. 1-8-02; Renumbered from 855-019-0040, BP 2-2008, f. & cert. ef. 2-20-08

Pharmacist Practice

855-019-0200

General Responsibilities of a Pharmacist

ORS 689.025 states that "the practice of pharmacy in the State of Oregon is declared a health care professional practice affecting the public health, safety and welfare". Pharmacy practice is a dynamic patient-oriented health service that applies a scientific body of knowledge to improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes. A pharmacist licensed to practice pharmacy by the Board has the duty to use that degree of care, skill, diligence and professional judgment that is exercised by an ordinarily careful pharmacist in the same or similar circumstances.

(1) A pharmacist while on duty must ensure that the pharmacy complies with all state and federal laws and rules governing the practice of pharmacy.

(2) A pharmacist shall perform the duties of a pharmacist that include, but are not limited to, DUR, counseling, and final verification of the work performed by those under their supervision.

(3) A pharmacist may not delegate any task that requires the professional judgment of a pharmacist. Such tasks include but are not limited to:

(a) Counseling to a patient or patient's agent, or other healthcare provider;

(b) Verification;

(c) Performing DUR;

(d) Providing a CDTM, DRR, or MTM service;

(e) Ordering, interpreting and monitoring of a laboratory test; and

(f) Oral receipt or transfer of a prescription; except that

(g) An intern under the supervision of a pharmacist may perform all the duties of a technician and the following:

(A) Counseling;

(B) Performing DUR;

(C) Oral receipt or transfer of a prescription,

(D) Immunizations if appropriately trained, and supervised by an immunization qualified pharmacist;

(E) Other activities approved in writing by the Board.

(4) A pharmacist who is supervising an intern is responsible for the actions of that intern, however, this does not absolve the intern from responsibility for their own actions.

(5) A pharmacist on duty is responsible for supervising all pharmacy personnel, and ensuring that pharmacy personnel only work within the scope of duties allowed by the Board.

(6) A pharmacist may not permit non-pharmacist personnel to perform any duty they are not licensed and trained to perform.

(7) A pharmacist while on duty is responsible for the security of the pharmacy area including:

(a) Providing adequate safeguards against theft or diversion of prescription drugs, and records for such drugs;

(b) Ensuring that all records and inventories are maintained in accordance with state and federal laws and rules;

(c) Ensuring that only a pharmacist has access to the pharmacy when the pharmacy is closed.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.025, 689.151, 689.155
Hist.: PB 15-1989, f. & cert. ef. 12-26-89; PB 2-1997(Temp), f. 10-2-97, cert. ef. 10-4-97; BP 2-1998, f. & cert. ef. 3-23-98; Renumbered from 855-041-0210, BP 2-2008, f. & cert. ef. 2-20-08; BP 6-2010, f. & cert. ef. 6-29-10

855-019-0205

Duty to Report

(1) Failure to answer completely, accurately and honestly, all questions on the application form for licensure or renewal of licensure is grounds for discipline.

(2) Failure to disclose any arrest for a felony or misdemeanor, or any indictment for a felony may result in denial of the application.

(3) A pharmacist must report to the Board within 10 days if they:

(a) Are convicted of a misdemeanor or a felony; or

(b) If they are arrested for a felony.

(4) A pharmacist who has reasonable cause to believe that another licensee (of the Board or any other Health Professional Regulatory Board) has engaged in prohibited or unprofessional conduct as these terms are defined in OAR 855-006-0005, must report that conduct to the board responsible for the licensee who is believed to have engaged in the conduct. The reporting pharmacist shall report the conduct without undue delay, but in no event later than 10 working days after the pharmacist learns of the conduct unless federal laws relating to confidentiality or the protection of health information prohibit disclosure.

(5) A pharmacist who reports to a board in good faith as required by section (4) of this rule is immune from civil liability for making the report.

(6) A pharmacist who has reasonable grounds to believe that any violation of these rules has occurred, must notify the Board within 10 days. However, in the event of a significant drug loss or violation related to drug theft, the pharmacist shall notify the Board within one (1) business day.

(7) A pharmacist must notify the Board in writing, within 15 days, of any change in employment location or residence address.

Stat. Auth.: ORS 689.205
Stats. Implemented: 689.151, 689.155 & 689.455
Hist.: BP 6-2010, f. & cert. ef. 6-29-10; BP 2-2014, f. & cert. ef. 1-24-14

855-019-0210

Duties of the Pharmacist Receiving a Prescription

(1) A pharmacist must ensure that all prescriptions, prescription refills, and drug orders are correctly dispensed or prepared for administration in accordance with the prescribing practitioner's authorization.

(2) A pharmacist receiving a prescription is responsible for:

(a) Using professional judgment in dispensing only pursuant to a valid prescription. A pharmacist shall not dispense a prescription if the pharmacist, in their professional judgment, believes that the prescription was issued without a valid patient-practitioner relationship. In this rule, the term practitioner shall include a clinical associate of the practitioner or any other practitioner acting in the practitioner's absence. The prescription must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice and not result solely from a questionnaire or an internet-based relationship; and

(b) Ensuring that the prescription contains all the information specified in Division 41 of this chapter of rules including the legible name and contact phone number of the prescribing practitioner for verification purposes.

(3) A pharmacist may refuse to dispense a prescription to any person who lacks proper identification.

(4) Oral Prescription: Upon receipt of an oral prescription, the pharmacist shall promptly reduce the oral prescription to writing or create a permanent electronic record by recording:

(a) The date when the oral prescription was received;

(b) The name of the patient for whom, or the owner of the animal for which, the drug is to be dispensed;

(c) The full name and, in the case of controlled substances, the address and the DEA registration number, of the practitioner, or other number as authorized under rules adopted by reference under Division 80 of this chapter of rules;

(d) If the oral prescription is for an animal, the species of the animal for which the drug is prescribed;

(e) The name, strength, dosage form of the substance, quantity prescribed;

(f) The direction for use;

(g) The total number of refills authorized by the prescribing practitioner;

(h) The written signature or initials or electronic identifier of the receiving pharmacist or intern and the identity of the person transmitting the prescription;

(i) The written or electronic record of the oral prescription must be retained on file as required by Division 41 of this chapter of rules, and in the case of controlled substances, under rules adopted by reference in Division 80 of this chapter of rules.

(5) Facsimile Prescription: Upon receipt of a facsimile prescription, the pharmacist must be confident that the prescription was sent by an authorized practitioner or practitioner's agent, and they must verify that:

(a) The facsimile contains all the information specified in division 41 and division 80 of this chapter of rules; and

(b) The facsimile prescription is not for a Schedule II controlled substance unless so permitted under federal regulations or division 80 of this chapter of rules; and

(c) If the facsimile prescription is for a controlled substance, the prescription contains an original, manually-signed signature of the prescriber. In this rule, manually-signed specifically excludes a signature stamp or any form of digital signature unless permitted under federal regulations.

(6) Electronic Prescription: Before filling a prescription that has been received electronically, the pharmacist must be confident that:

(a) The prescription was originated by an authorized practitioner or practitioner's agent;

(b) The prescription contains all the information specified in Division 41 of this chapter of rules.

(c) The prescription is not for a controlled substance unless permitted by federal regulations.

(7) The pharmacist must ensure that a written prescription that is hand-carried or mailed into the pharmacy contains an original manually-signed signature of the prescribing practitioner or practitioner's agent.

(8) Computer Transfer of Prescription Information between Pharmacies: A pharmacist that transmits or receives prescription information to or from another pharmacy electronically must ensure as appropriate:

(a) The accurate transfer of prescription information between pharmacies;

(b) The creation of an original prescription or image of an original prescription containing all the information constituting the prescription and its relevant refill history in a manner that ensures accuracy and accountability and that the pharmacist will use in verifying the prescription;

(c) The prescription is invalidated at the sending pharmacy; and

(d) Compliance with all relevant state and federal laws and rules regarding the transfer of controlled substance prescriptions.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155, 689.508
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1994, f. & cert. ef. 2-2-94; Renumbered from 855-041-0085, BP 2-2008, f. & cert. ef. 2-20-08

Pharmacist Care and Practice

855-019-0220

Drug Utilization Review (DUR)

(1) A pharmacist shall maintain a record for each patient that contains easily retrievable information necessary for the pharmacist to perform a DUR and to identify previously dispensed drugs at the time a prescription or drug order is presented for dispensing or preparing for administration. The pharmacist shall make a reasonable effort to obtain, record, and maintain the following information:

(a) Full name of the patient for whom the drug is prescribed;

(b) Address and telephone number of the patient;

(c) Patient's gender, age or date of birth;

(d) Chronic medical conditions and disease states of the patient;

(e) A list of all drugs or devices the patient is currently obtaining at that pharmacy showing the name of the drug or device, strength of the drug, the quantity and date received, and the name of the prescribing practitioner;

(f) Known allergies, adverse drug reactions, and drug idiosyncrasies;

(g) Pharmacist comments relevant to the individual's drug therapy, including any other information specific to that patient or drug; and

(h) Additional information, which may relate to DUR, or for the monitoring of the patient as appropriate.

(2) Patient records shall be maintained for at least three years.

(3) The pharmacist or intern shall perform a DUR prior to dispensing or preparing for administration any prescription or refill.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155
Hist.: BP 2-2008, f. & cert. ef. 2-20-08

855-019-0230

Counseling

(1) The pharmacist or intern shall orally counsel the patient or patient's agent on the use of a drug or device as appropriate:

(a) The pharmacist or intern shall counsel the patient on a new prescription and any changes in therapy, including but not limited to a change in directions or strength, or a prescription which is new to the pharmacy;

(b) Only the pharmacist or intern may accept a patient's or patient's agent's request not to be counseled. If, in their professional judgment, the pharmacist or intern believes that the patient's safety may be affected, the pharmacist or intern may choose not to release the prescription until counseling has been completed;

(c) Effective July 1, 2008, the pharmacist or intern that provides counseling or accepts the request not to be counseled shall document the interaction;

(d) A pharmacist shall not allow non-pharmacist personnel to release a prescription that requires counseling, or accept the request not to be counseled;

(e) For a prescription delivered outside of the pharmacy, the pharmacist shall offer in writing, to provide direct counseling and information about the drug, including information on how to contact the pharmacist;

(f) For each patient, the pharmacist or intern shall determine the amount of counseling that is reasonable and necessary under the circumstance to promote safe and effective use or administration of the drug or device, and to facilitate an appropriate therapeutic outcome for that patient.

(2) Counseling on a refill prescription shall be such as a reasonable and prudent pharmacist would provide including but not limited to changes in strength or directions.

(3) A pharmacist may provide counseling in a form other than oral counseling when, in their professional judgment, a form of counseling other than oral counseling would be more effective.

(4) A pharmacist or intern shall initiate and provide counseling under conditions that maintain patient privacy and confidentiality.

(5) For a discharge prescription from a hospital, the pharmacist must ensure that the patient receives appropriate counseling.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155
Hist.: 1PB 2-1980, f. & ef. 4-3-80; PB 8-1990, f. & cert. ef. 12-5-90; PB 5-1992, f. & cert. ef. 10-23-92; PB 1-1994, f. & cert. ef. 2-2-94; BP 4-1998, f. & cert. ef. 8-14-98; BP 1-2002, f. & cert. ef. 1-8-02; Renumbered from 855-041-0100, BP 2-2008, f. & cert. ef. 2-20-08

855-019-0240

Consulting Pharmacist Practice

(1) Subject to the provisions of OAR 855-019-0100(4), a consulting pharmacist who provides services to any person or facility located in Oregon, must be an Oregon licensed pharmacist.

(2) A consulting pharmacist for an Oregon licensed healthcare facility must perform all duties and functions required by the healthcare facility's licensure as well as by any relevant federal and state laws and rules.

(3) A consulting pharmacist must maintain appropriate records of their consulting activities for three years, and make them available to the Board for inspection.

(4) A consulting pharmacist is responsible for the safe custody and security of all their records and must comply with all relevant federal and state laws and regulations concerning the security and privacy of patient information.

(5) A consulting pharmacist for a facility that is required by the Board to have a consultant pharmacist but which does not have additional consulting requirements under the terms of its licensure with any other state agency, shall provide services that include but are not limited to the following:

(a) Provide the facility with policies and procedure relating to security, storage and distribution of drugs within the facility;

(b) Provide guidance on the proper documentation of drug administration or dispensing;

(c) Provide educational materials or programs as requested.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155
Hist.: BP 2-2008, f. & cert. ef. 2-20-08; BP 6-2010, f. & cert. ef. 6-29-10

855-019-0250

Medication Therapy Management

(1) Medication Therapy Management (MTM) is a distinct service or group of services that is intended to optimize the therapeutic outcomes of a patient. Medication Therapy Management can be an independent service provide by a pharmacist or can be in conjunction with the provision of a medication product with the objectives of:

(a) Enhancing appropriate medication use;

(b) Improving medication adherence;

(c) Increasing detection of adverse drug events;

(d) Improving collaboration between practitioner and pharmacist; and

(e) Improving outcomes.

(2) A pharmacist that provides MTM services shall ensure that they are provided according to the individual needs of the patient and may include but are not limited to the following:

(a) Performing or otherwise obtaining the patient’s health status assessment;

(b) Developing a medication treatment plan for monitoring and evaluating the patient’s response to therapy;

(c) Monitoring the safety and effectiveness of the medication therapy;

(d) Selecting, initiating, modifying or administering medication therapy in consultation with the practitioner where appropriate;

(e) Performing a medication review to identify, prevent or resolve medication related problems;

(f) Monitoring the patient for adverse drug events;

(g) Providing education and training to the patient or the patient’s agent on the use or administration of the medication;

(h) Documenting the delivery of care, communications with other involved healthcare providers and other appropriate documentation and records as required. Such records shall:

(A) Provide accountability and an audit trail; and

(B) Be preserved for at least three years and be made available to the Board upon request except that when records are maintained by an outside contractor, the contract must specify that the records be retained by the contractor and made available to the Board for at least three years.

(i) Providing necessary services to enhance the patient’s adherence with the therapeutic regimen;

(j) Integrating the medication therapy management services within the overall health management plan for the patient; and

(k) Providing for the safe custody and security of all records and compliance with all relevant federal and state laws and regulations concerning the security and privacy of patient information.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155
Hist.: BP 2-2008, f. & cert. ef. 2-20-08; BP 6-2010, f. & cert. ef. 6-29-10

855-019-0260

Collaborative Drug Therapy Management

(1) As used in this rule "Collaborative Drug Therapy Management" (CDTM) means the participation by a practitioner and a pharmacist in the management of drug therapy pursuant to a written agreement that includes information on 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 practitioner and one pharmacist; or

(b) Is agreed to by 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, and one or more pharmacists.

(2) A pharmacist shall engage in collaborative drug therapy management with a practitioner only under a written arrangement that includes:

(a) The identification, either by name or by description, of each of the participating pharmacists;

(b) The identification, by name or description, of each of the participating practitioners or group of practitioners;

(c) The name of the principal pharmacist and practitioner who are responsible for development, training, administration, and quality assurance of the arrangement;

(d) The types of decisions that the pharmacist is allowed to make, which may include:

(A) A detailed description of the types of diseases, drugs, or drug categories involved, and the activities allowed in each case;

(B) A detailed description of the methods, procedures, decision criteria, and plan the pharmacist is to follow when conducting allowed activities;

(C) A detailed description of the activities the pharmacist is to follow including documentation of decisions made and a plan or appropriate mechanism for communication, feedback, and reporting to the practitioner concerning specific decisions made. In addition to the agreement, documentation shall occur on the prescription record, patient profile, a separate log book, or in some other appropriate system;

(D) Circumstances which will cause the pharmacist to initiate communication with the practitioner, including but not limited to the need for a new prescription order and a report of a patient's therapeutic response or any adverse effect.

(e) Training requirement for pharmacist participation and ongoing assessment of competency, if necessary;

(f) Quality assurance and periodic review by a panel of the participating pharmacists and practitioners;

(g) Authorization by the practitioner for the pharmacist to participate in collaborative drug therapy; and

(h) A requirement for the collaborative drug therapy arrangement to be reviewed and updated, or discontinued at least every two years;

(3) The collaborative drug therapy arrangement and associated records must be kept on file in the pharmacy and made available to any appropriate health licensing board upon request.

(4) Nothing in this rule shall be construed to allow therapeutic substitution outside of the CDTM agreement.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155
Hist.: Hist.: BP 4-1998, f. & cert. ef. 8-14-98; BP 1-1999(Temp), f. & cert. ef. 1-29-99 thru 7-28-99; Administrative correction 8-9-99; BP 1-2000, f. & cert. ef. 2-16-00; Renumbered from 855-041-0400, BP 2-2008, f. & cert. ef. 2-20-08; BP 9-2011, f. 12-30-11, cert. ef. 1-1-12

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

Administration of Vaccines by Pharmacists

855-019-0270

Qualifications

(1) In this rule and in OAR 855-019-0280, an intern who is appropriately trained and qualified in accordance with Section (3) of this rule may perform the same duties as a pharmacist, provided that the intern is supervised by an appropriately trained and qualified pharmacist.

(2) A pharmacist may administer vaccines to persons who are at least 11 years of age as provided by these rules. For the purposes of this rule, a person is at least 11 years of age on the day of the person's eleventh birthday.

(3) A pharmacist may administer vaccines under section (1) or section (2) of this rule only if:

(a) The pharmacist has completed a course of training approved by the Board;

(b) The pharmacist holds a current basic Cardiopulmonary Resuscitation (CPR) certification issued by the American Heart Association or the American Red Cross or any other equivalent program that contains a hands-on training component and is valid for not more than three years, and documentation of the certification is placed on file in the pharmacy;

(c) The vaccines are administered in accordance with an administration protocol written and approved by the Oregon Health Authority (OHA); and

(d) The pharmacist has a current copy of the CDC reference, "Epidemiology and Prevention of Vaccine-Preventable Diseases."

(4) A pharmacist otherwise in compliance with section three of this rule may, during a declared emergency, administer a vaccine to a person who is at least three (3) years of age when;

(a) The Governor declares a state of public health emergency and authorizes the reduced age limitation; or

(b) The Public Health Director, during a declared disease outbreak, authorizes a reduction in the age limit.

(5) A pharmacist may not delegate the administration of vaccines to another person.

Stat. Auth.: ORS 689.205 433.441, 433.443 & 2013 OL Ch 332
Stats. Implemented: ORS 689.151, 689.155, 689.645 & 2013 OL Ch 332
Hist.: BP 7-2000, f. & cert. ef. 6-29-00; BP 3-2006, f. & cert. ef. 6-9-06; BP 1-2007, f. & cert. ef. 6-29-07; Renumbered from 855-041-0500, BP 2-2008, f. & cert. ef. 2-20-08; BP 11-2010, f. 10-22-10, cert. ef. 1-1-11; BP 2-2014, f. & cert. ef. 1-24-14

855-019-0280

Protocols, Policies and Procedures

(1) Prior to administering a vaccine to a person who is at least 11 years of age a pharmacist must follow protocols written and approved by the Oregon Health Authority (OHA)for administration of vaccines and the treatment of severe adverse events following administration of a vaccine.

(2) A pharmacist during a declared emergency may administer a vaccine to a person who is at least three (3) years of age when;

(a) The Governor declares a state of public health emergency and authorizes the reduced age limitation; or

(b) The Public Health Director, during a declared disease outbreak, authorizes a reduction in the age limit.

(3) The pharmacy must maintain written policies and procedures for handling and disposal of used or contaminated equipment and supplies.

(4) The pharmacist must give the appropriate Vaccine Information Statement (VIS) to the patient or legal representative with each dose of vaccine covered by these forms. The pharmacist must ensure that the patient or legal representative is available and has read, or has had read to them, the information provided and has had their questions answered prior to administering the vaccine.

(5) The pharmacist must report adverse events as required by the Vaccine Adverse Events Reporting System (VAERS) and to the primary care provider as identified by the patient.

(6) The pharmacist must make available the Adolescent Well Visit Referral document, provided by the OHA, to a patient aged 11 through 18 years of age or their legal representative.

(7) The pharmacist may administer or dispense an oral vaccine as established by written protocols approved by OHA.

Stat. Auth.: ORS 689.205, 433.441, 433.443 & 2013 OL Ch 332
Stats. Implemented: ORS 689.151, 689.155, 689.645 2013 OL Ch 332
Hist.: BP 7-2000, f. & cert. ef. 6-29-00; BP 3-2006, f. & cert. ef. 6-9-06: Renumbered from 855-041-0510, BP 2-2008, f. & cert. ef. 2-20-08; BP 11-2010, f. 10-22-10, cert. ef. 1-1-11; BP 9-2011, f. 12-30-11, cert. ef. 1-1-12; BP 2-2014, f. & cert. ef. 1-24-14

855-019-0290

Record Keeping and Reporting

(1) A pharmacist who administers a vaccine to a patient must fully document the administration in the patient’s permanent record.

(2) A pharmacist who administers any vaccine must report the following elements to the OHA ALERT Immunization Information System in a manner prescribed by OHA within 15 days of administration. This replaces the former requirement to notify the primary health care provider. A pharmacist is not required to notify the primary health care provider.

(a) The name, address, gender and date of birth of the patient;

(b) The date of administration of the vaccine;

(c) The NDC number of the vaccine, or other acceptable standardized vaccine code set;

(d) The address of the pharmacy where vaccine was administered unless automatically embedded in the electronic report provided to the OHA ALERT Immunization System;

(e) The phone number of the patient when available;

(f) The dose amount, manufacturer, site of administration, lot number and expiration date of the vaccine when available;

(3) A pharmacist who administers any vaccine will keep documentation of current CPR training. This documentation will be kept on site and available for inspection.

(4) A pharmacist who administers any vaccine will follow storage and handling guidance from the vaccine manufacturer and the Centers for Disease Control and Prevention (CDC).

(5) For the purpose of participation in the Oregon Vaccines for Children program,

(a) The vaccine eligibility code for each dose must be reported to the ALERT Immunization Information System in the manner prescribed by OHA, and

(b) The pharmacist is recognized as a prescriber.

(6) If providing state or federal vaccines during a pandemic as determined by the CDC, the event and priority code as specified by OHA must be provided upon request in the manner prescribed by OHA.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155, 689.645
Hist.: BP 7-2000, f. & cert. ef. 6-29-00; BP 3-2006, f. & cert. ef. 6-9-06: Renumbered from 855-041-0520, BP 2-2008, f. & cert. ef. 2-20-08; BP 11-2010, f. 10-22-10, cert. ef. 1-1-11; BP 9-2011, f. 12-30-11, cert. ef. 1-1-12

Pharmacist-in-Charge

855-019-0300

Duties of a Pharmacist-in-Charge

(1) In accordance with Division 41 of this chapter of rules, a pharmacy must, at all times have one Pharmacist-in-Charge (PIC) employed on a regular basis.

(2) In order to be a PIC, a pharmacist must have:

(a) Completed at least one year of pharmacy practice; or

(b) Completed a Board approved PIC training course either before the appointment or within 30 days after the appointment. With the approval of the Board, this course may be employer provided and may qualify for continuing education credit.

(3) A pharmacist may not be designated PIC of more than two pharmacies without prior written approval by the Board. If such approval is given, the pharmacist must comply with the requirements in sub-section (4)(e) of this rule.

(4) The PIC must perform the following the duties and responsibilities:

(a) When a change of PIC occurs, both outgoing and incoming PICs must report the change to the Board within 15 days of the occurrence, on a form provided by the Board;

(b) The new PIC must complete an inspection on the PIC Annual Self-Inspection Form, within 15 days of becoming PIC;

(c) The PIC may not authorize non-pharmacist employees to have unsupervised access to the pharmacy, except in the case of hospitals that do not have a 24-hour pharmacy where access may be granted as specified in OAR 855-041-0120;

(d) In a hospital only, the PIC is responsible for providing education and training to the nurse supervisor who has been designated to have access to the pharmacy department in the absence of a pharmacist;

(e) A pharmacist designated as PIC for more than one pharmacy shall personally conduct and document a quarterly compliance audit at each location. This audit shall be on the Quarterly PIC Compliance Audit Form provided by the Board;

(f) If a discrepancy is noted on a Board inspection, the PIC must submit a plan of correction within 30 days of receiving notice.

(g) The records and forms required by this section must be filed in the pharmacy, made available to the Board for inspection upon request, and must be retained for three years.

(5) The PIC is responsible for ensuring that the following activities are correctly completed:

(a) An inventory of all controlled substances must be taken within 15 days before or after the effective date of change of PIC, and must be dated and signed by the new PIC. This inventory must be maintained in the pharmacy for three years and in accordance with all federal laws and regulations;

(b) Verifying, on employment and as appropriate, but not less than annually, the licensure of all pharmacy personnel who are required to be licensed by the Board;

(c) Conducting an annual inspection of the pharmacy using the PIC Annual Self-Inspection Form provided by the Board, by February 1 each year. The completed self-inspection forms must be signed and dated by the PIC and maintained for three years from the date of completion;

(d) Conducting an annual inventory of all controlled drugs as required by OAR 855-080;

(e) Performing a quarterly inventory reconciliation of all Schedule II controlled drugs.

(f) Ensuring that all pharmacy staff have been trained appropriately for the practice site. Such training should include an annual review of the PIC Self-Inspection Report;

(g) Implementing a quality assurance plan for the pharmacy.

(h) The records and forms required by this section must be filed in the pharmacy, made available to the Board for inspection upon request, and must be retained for three years.

(6) The PIC, along with other licensed pharmacy personnel, must ensure that the pharmacy is in compliance with all state and federal laws and rules governing the practice of pharmacy and that all controlled substance records and inventories are maintained in accordance with all state and federal laws and rules.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155
Hist.: BP 2-2008, f. & cert. ef. 2-20-08; BP 6-2010, f. & cert. ef. 6-29-10

Discipline

855-019-0310

Grounds for Discipline

The State Board of Pharmacy may suspend, revoke, or restrict the license of a pharmacist or intern or may impose a civil penalty upon the pharmacist or intern upon the following grounds:

(1) Unprofessional conduct as defined in OAR 855-006-0005;

(2) Repeated or gross negligence;

(3) Impairment, which means an inability to practice with reasonable competence and safety due to the habitual or excessive use of drugs or alcohol, other chemical dependency or a mental health condition;

(4) Being found guilty by the Board of a violation of the pharmacy or drug laws of this state or rules pertaining thereto or of statutes, rules or regulations of any other state or of the federal government;

(5) Being found guilty by a court of competent jurisdiction of a felony as defined by the laws of this state;

(6) Being found guilty by a court of competent jurisdiction of a violation of the pharmacy or drug laws of this state or rules pertaining thereto or of statutes, rules or regulations of any other state or of the federal government;

(7) Fraud or intentional misrepresentation in securing or attempting to secure the issuance or renewal of a license to practice pharmacy or a drug outlet registration;

(8) Permitting an individual to engage in the practice of pharmacy without a license or falsely using the title of pharmacist;

(9) Aiding and abetting an individual to engage in the practice of pharmacy without a license or falsely using the title of pharmacist;

(10) Being found by the Board to be in violation of any violation of any of the provisions of ORS 435.010 to 435.130, 453.025, 453.045, 475.035 to 475.190, 475.805 to 475.995 or 689.005 to 689.995 or the rules adopted pursuant thereto; or

(11) Failure to perform appropriately the duties of a pharmacist while engaging in the practice of pharmacy as defined in ORS 689.005.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155, 689.405, OL 2009, Ch. 756
Hist.: PB 1-1989, f. & cert. ef. 1-3-89; BP 1-2002, f. & cert. ef. 1-8-02; BP 6-2005(Temp), f. & cert. ef. 6-28-05 thru 12-13-05; Administrative correction 12-20-05; Renumbered from 855-019-0055, BP 2-2008, f. & cert. ef. 2-20-08; BP 6-2010, f. & cert. ef. 6-29-10

855-019-0320

Petition for Reinstatement of Pharmacist Licenses

(1) A pharmacist license which has been revoked, suspended or restricted will be reinstated only if the Board finds, upon a presentation made by the petitioner, that there is a reasonable assurance that the public interest will be protected if relicensure occurs.

(2) A presentation must consist of a showing by the petitioner of changed circumstances from those surrounding the revocation, suspension or restriction of license. The presentation must include:

(a) A showing that the petitioner has engaged in treatment, programs, or other endeavors or activities since the suspension, revocation or restriction of license which has caused the rehabilitation of the petitioner to the extent that the public's interest would be protected if relicensure should be granted.

(b) Medical, psychological, sociological or other physical, mental or moral appraisals, evaluations or recommendations relating to the petitioner to aid the Board in its determination whether the petitioner has been rehabilitated to the extent that the public's interest would be protected if relicensure should be granted.

(3) Petitions to the Board for reinstatement of licensure after suspension, revocation or restriction must be in writing and must contain:

(a) A written statement of those changed circumstances which the petitioner believes warrant the Board's finding that there is a reasonable assurance that the public interest will be protected if relicensure occurs. Such statement must include a recitation of the treatment, programs, or other endeavors or activities undertaken by the petitioner, more particularly referred to subsection (2)(a) of this rule.

(b) A summarization of the medical, psychological, sociological or other physical, mental, or moral appraisals or recommendations which the petitioner intends to present to the Board pursuant to subsection (2)(b) of this rule.

(4) If, after opportunity is afforded the petitioner to show otherwise, the Board determines that a petition fails to comply with section (3) of this rule, or has not been made within a reasonable interval from the suspension, revocation, or restriction of license or from a previous petition, the Board will dismiss the petition without further investigation and hearing before the Board.

(5) Petitions which comply with section (3) of this rule will be scheduled for presentation of proof before the Board, and the petitioner will be notified of the time and place.

(6) The completion of any treatment, program or activity which the Board may recommend does not establish a right to reinstatement. The Board must, in each and every case, make a finding based upon the presentation of the petitioner that there is a reasonable assurance that the public interest will be protected if relicensure occurs.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.151, 689.155, 689.445
Hist.: 1PB 1-1982, f. & ef. 3-8-82; BP 1-2002, f. & cert. ef. 1-8-02; Renumbered from 855-019-0050, BP 2-2008, f. & cert. ef. 2-20-08

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