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Oregon Bulletin

February 1, 2012

 

Board of Pharmacy
Chapter 855

Rule Caption: Amend or adopt new Collaborative Therapy, Immunization, Intern, Pharmacy Depots and Manufacturer rules.

Adm. Order No.: BP 9-2011

Filed with Sec. of State: 12-30-2011

Certified to be Effective: 1-1-12

Notice Publication Date: 11-1-2011

Rules Adopted: 855-031-0026, 855-060-0004

Rules Amended: 855-019-0260, 855-019-0280, 855-019-0290, 855-031-0010, 855-031-0020, 855-031-0045, 855-041-0095

Subject: Division 19 rules are amended to clarify requirements for Therapeutic substitution and the Administration of Vaccines. Division 31 Intern rules are amended for clarification. Division 41 Pharmacy Depot rules are amended to allow for exceptions. Division 60 updates the Manufacturer rules to more clearly identify which entities must register as Manufacturers.

      Complete text of these rules are available on the Board’s website at www.pharmacy.state.or.us.

Rules Coordinator: Karen MacLean—(971) 673-0001

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

855-019-0280

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

(3) 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.

(4) 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.

(5) 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.

(6) The pharmacist may administer or dispense an oral vaccine as established by written protocols approved 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 855-041-0510, 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

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

855-031-0010

Intern License Application

(1) Applications for licensure as an intern may be obtained from the Board office or from the Board web site at www.pharmacy.state.or.us.

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

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

(2) The Board may issue a license to a qualified intern after the receipt of:

(a) A completed application;

(b) Payment of the fee prescribed in OAR 855-110-0005;

(c) A current, passport regulation size photograph (full front, head to shoulders);

(d) Any fingerprint card or other documentation required by the Board to conduct a criminal background check; and

(e) Confirmation from a school of pharmacy that the applicant is enrolled in a course of study, except for foreign pharmacy graduates who must:

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

(B) Provide the original certificate issued by the Foreign Pharmacy Graduate Equivalency Examination Committee; and

(C) Provide evidence that they have passed the Test of English as a Foreign Language (TOEFL) Internet-based Test (IBT) with a minimum score of 26 in Speaking, 21 in Reading, 18 in Listening and 24 in Writing, however scores will be accepted until June 30, 2010 from candidates who have already passed or are scheduled to take the TOEFL and the Test of Spoken English (TSE).

(3) The Board may issue an intern license after processing the application, however unless the applicant is a foreign graduate or an applicant for licensure by reciprocity, it is not valid until the intern has started a course of study. For licenses issued after May 1, 2010, the initial license is valid until the last day of November following the second anniversary of issue unless terminated automatically by any one of the following events. Renewed licenses are valid for two years unless terminated automatically by any one of the following events:

(a) Licensure to practice pharmacy is granted in any state; or

(b) The licensee, other than a foreign pharmacy graduate or an applicant for licensure by reciprocity, fails to maintain enrollment or active registration in a pharmacy degree program for a period greater than one year; or

(c) The licensee, other than a foreign pharmacy graduate or an applicant for licensure by reciprocity, has been graduated from a school of pharmacy for 12 months;

(d) The intern is dismissed, terminated or expelled by the school of pharmacy, or withdraws from the program.

(4) An intern must surrender their license to the Board within 30 days of one of the above events.

(5) Notwithstanding the requirements of section (3) above, upon written request the Board may waive any of the requirements of this rule if a waiver will further public health and safety. A waiver granted under this section shall only be effective when it is issued in writing.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 689.151 & 689.205

Stats. Implemented: ORS 689.207, 689.255 & 2009 OL Ch. 536

Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 7-1990, f. & cert. ef. 12-5-90; PB 1-1994, f. & cert. ef. 2-2-94; BP 1-2001, f. & cert. ef. 3-5-01; BP 1-2002, f. & cert. ef. 1-8-02; BP 1-2007, f. & cert. ef. 6-29-07; BP 3-2010, f. 4-29-10, cert. ef. 4-30-10; BP 9-2011, f. 12-30-11, cert. ef. 1-1-12

855-031-0020

Intern Requirements and Responsibilities

(1) A licensed intern may practice in any one or a combination of the following approved internship experience areas:

(a) Traditional Pharmacy-practice Internship (TPI): an intern may not work in a TPI until after satisfactorily completing the first academic year in a school of pharmacy. An intern working in a TPI must be supervised by a licensed pharmacist or pharmacist preceptor;

(b) School-based Rotational Internship (SRI): an intern must be supervised by a licensed pharmacist or other person approved by a school of pharmacy to obtain credit for SRI hours;

(c) Other Internship.

(2) An intern may not work more than 48 hours per week in SRIs and must comply with all supervision and ratio requirements.

(3) An intern must verify that their preceptor is currently licensed with the Board.

(4) An intern may not work in the practice of pharmacy unless supervised by a licensed pharmacist, except when an intern is working in a federal facility, however, to obtain credit for SRI experience in a federal facility located in Oregon, the intern must be licensed with the Board.

(5) An intern who is working in a pharmacy or other place of business must conspicuously display their intern license in the pharmacy or place of business and must be clearly identified as an intern at all times.

(6) An intern may perform only the duties listed in Division 25 of this Chapter before completion of the first academic year in a school of pharmacy.

(7) An intern may, after successful completion of their first academic year, perform the duties of an intern listed in Division 019 of this Chapter, but only after successful completion of coursework corresponding to those duties at their school of pharmacy and only with the permission of their supervising pharmacist.

(8) An intern is responsible for his or her own actions and must comply with all Board regulations.

(9) An intern must notify the Board within 15 days of any change in their academic status that might affect their eligibility to work as an intern.

(10) An intern must notify the Board in writing within 15 days of a change in permanent residence and TPI site.

(11) An intern must report to the Board within 10 days if they are:

(a) Convicted of a misdemeanor or a felony; or

(b) Arrested for a felony.

(12) An intern 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 intern shall report the conduct without undue delay, but in no event later than 10 working days after the intern learns of the conduct unless federal laws relating to confidentiality or the protection of health information prohibit disclosure.

(13) If needed by an intern for compliance with another Board’s requirement, an intern must maintain written or electronic records that support the number of TPI hours claimed by an intern and have those hours certified by a preceptor.

(14) An intern may make a voluntary report to the Board on any preceptor’s aptitude and professionalism in performing the duties of a preceptor. An intern must make such a report upon request by the Board.

Stat. Auth.: ORS 689.151, 689.205

Stats. Implemented: 689.255 & 2009 OL Ch. 536

Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 7-1990, f. & cert. ef. 12-5-90; PB 3-1991, f. & cert. ef. 9-19-91; PB 1-1994, f. & cert. ef. 2-2-94; PB 3-1994, f. & cert. ef. 7-1-94; BP 1-2002, f. & cert. ef. 1-8-02; BP 1-2007, f. & cert. ef. 6-29-07; BP 3-2010, f. 4-29-10, cert. ef. 4-30-10; BP 9-2011, f. 12-30-11, cert. ef. 1-1-12

855-031-0026

Ratio & Supervision

(1) A pharmacist may not supervise more than one intern at a time at a TPI site who performs the duties of an intern as listed in OAR 855-019-0200(3)(g). A pharmacist may supervise more than one intern if only one intern performs the duties of an intern as listed in OAR 855-019-0200(3)(g) and if other interns supervised by the pharmacist perform the duties listed in OAR 855-025-0040.

(2) A preceptor may not supervise more than two interns simultaneously during a shift at an SRI site where patient specific recommendations for care or medications are provided without prior written authorization of the Board.

(3) With the written approval of a school of pharmacy, and when in their professional judgment it is appropriate, a preceptor may supervise up to 10 interns at public-health outreach programs such as informational health fairs that provide general information but not direct patient care.

(4) For immunization clinics, an immunizing pharmacist may supervise up to two immunizing interns.

(5) A licensed preceptor may delegate the preceptor responsibilities to another licensed pharmacist or preceptor.

(6) The majority of an intern’s overall experience must be with a licensed pharmacist preceptor.

Stat. Auth.: ORS 689.151, 689.205

Stats. Implemented: 689.255 & 2009 OL Ch. 536

Hist.: BP 9-2011, f. 12-30-11, cert. ef. 1-1-12

855-031-0045

School and Preceptor Registration and Responsibilities

(1) A preceptor license may be issued by the Board upon receipt of a completed application.

(2) A pharmacist preceptor must have been an actively practicing pharmacist for at least one year immediately prior to supervising an intern.

(3) A preceptor license must be renewed annually and is valid through June 30.

(4) The preceptor may report to the Board voluntarily, the progress and aptitude of an intern under the preceptor’s supervision, or must do so upon request of the Board.

(5) The preceptor must be responsible for supervision of the majority of the intern’s SRI hours and must provide the intern with internship experiences, which in the preceptor’s judgment will increase the intern’s competency in the practice of pharmacy.

(6) Before supervising an intern in an SRI program, a preceptor must complete any training program required by the school of pharmacy.

(7) A preceptor must advise each school of pharmacy when they are supervising students from more than one school at the same time. This applies to both in-state and out-of-state schools or colleges of pharmacy.

(8) A preceptor must verify that their intern is currently licensed with the Board.

(9) A pharmacist acting as a preceptor in a federal facility is not required to be licensed as a pharmacist in Oregon, but is required to be licensed as a preceptor with the Board.

(10) The school of pharmacy must maintain a record of each intern’s SRIs. This record must be made available to the Board upon request.

(11) A school of pharmacy located in Oregon must submit a report on their experiential education program to the Board at the end of each academic year. This report must include the names of students who successfully completed the program and graduated from the school. The school must maintain a list of preceptors and SRI sites, in and out-of-state, approved by the school and must make this list available to the Board upon request.

(12) All records related to a student must be available for three years after the student graduates.

Stat. Auth.: ORS 689.151, 689.205

Stats. Implemented: 689.255

Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 7-1990, f. & cert. ef. 12-5-90; 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; BP 1-2004, f. & cert. ef. 3-12-04; BP 1-2007, f. & cert. ef. 6-29-07; BP 3-2010, f. 4-29-10, cert. ef. 4-30-10; BP 9-2011, f. 12-30-11, cert. ef. 1-1-12

855-041-0095

Pharmacy Depots

(1) Except when delivering directly to a patient, licensed pharmacists may not participate in the transfer of completed prescription medication containers to or from any location that is not a licensed pharmacy, unless the transfer occurs to:

(a) The home or office of the patient’s health care practitioner;

(b) The location of the patient; or location designated by the patient; or

(c) At the hospital or medical care facility in which a patient is receiving care.

(2) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health or safety or the health and safety of a patient. A waiver granted under this section shall only be effective when it is issued by the Board in writing.

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155

Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; BP 9-2011, f. 12-30-11, cert. ef. 1-1-12

855-060-0004

Registration

(1) Any person that manufactures, or contracts for the manufacture of a drug or prescription device that is intended for sale, distribution, dispensing or administration in Oregon must register with the Oregon Board of Pharmacy.

(2) Any person that holds one or more of the following registrations with the Federal Food and Drug Administration (FDA) must register as a Manufacturer.

(a) A New Drug Application number (NDA);

(b) An Abbreviated New Drug Application number (ANDA);

(c) A Labeler Code number (LC) or National Drug Code number (NDC);

(d) An FDA Central File Number (CFN);

(e) An FDA Establishment Identifier number (FEI).

(f) A Biologic License Application (BLA).

(3) A person that is registered with the FDA as a repackager must register as a Manufacturer.

(4) A person whose sole purpose is the marketing, brokering or arranging the initial distribution of drugs manufactured by a manufacturer, but does not take physical possession of a product must register as a Drug Distribution Agent under OAR 855-062-0005.

(5) A person who is registered with the FDA as the Agent for a foreign manufacturer must register as a Drug Distribution Agent under OAR 855-062-0005.

(6) An applicant for a new or renewal of registration must provide all information specified on the form provided by the Board, and pay the fee as specified in OAR 855-110-0007. The applicant must also provide any additional information requested by the Board. An application that does not contain all required information is incomplete and will not be processed.

(7) The registration is non-transferable. Addition or deletion of an owner shall be considered as a change of ownership except where the registrant is a publicly held corporation. A new application for registration and payment of a new registration fee is required when a registrant changes ownership or location. This new application must be submitted to the Board at least 15 days prior to the change.

(8) Not withstanding any of the above sections, a person who compounds a drug, as a part of a Shared Pharmacy Services agreement as defined in OAR 855-006-0005, who does not otherwise qualify as a manufacturer, does not need to register with the Board as a Manufacturer.

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155, 689.305

Hist.: BP 9-2011, f. 12-30-11, cert. ef. 1-1-12

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, 2011.

2.) Copyright 2012 Oregon Secretary of State: Terms and Conditions of Use

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