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Oregon State Archives

Oregon Bulletin

February 1, 2011

Board of Pharmacy
Chapter 855

Rule Caption: Adopt Heath Professional’s Service Program rules, clarify rule on electronic prescribing, amend continuing education requirements.

Adm. Order No.: BP 12-2010

Filed with Sec. of State: 12-23-2010

Certified to be Effective: 12-23-10

Notice Publication Date: 11-1-2010

Rules Adopted: 855-011-0005, 855-011-0020, 855-011-0030, 855-011-0040, 855-011-0050

Rules Amended: 855-021-0010, 855-041-0065

Rules Repealed: 855-011-0005(T), 855-011-0020(T), 855-011-0030(T), 855-011-0040(T), 855-011-0050(T)

Subject: (1) The Health Professional’s Service Program is the impaired health professionals program established by the Oregon Health Authority pursuant to ORS 676.190. These rules provide a framework for the Board of Pharmacy’s participation in the Program and establish a procedure for the Board to refer licensees to the program. The rules also specify a process for the Board to approve an independent evaluator and set requirements that must be met by participants. The rules replace the Temporary Rules effective from June 29, 2010.

(2) The amendment to the Continuing Education rule deletes the requirement that 11 hours need to be in “therapeutics”. The Board has added a requirement that one hour be in the topic of Patient Safety or Medication Error Reduction.

(3) ORS 689.515 was revised in 2009 to permit “no substitution” instructions to be electronic or in writing. This amendment to OAR 855-041-0065 brings regulations in line with statute.

Copies of the full text of these rules can be obtained from the Board’s web site, www.pharmacy.state.or.us, or by calling the Board office (971) 673-0001.

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

855-011-0005

Definitions

When used in this division of rules:

(1) “Health Professionals’ Service Program (the Program)” means the impaired health professional program established by the Oregon Health Authority pursuant to authority granted by ORS 676.190.

(2) “Impaired” means that the licensee is unable to practice with professional skill and safety by reason of habitual or excessive use or abuse of drugs, alcohol or other substances that impair ability, or by reason of a mental health disorder.

(3) “Mental-health disorder” means a clinically significant behavioral or psychological syndrome or pattern that occurs in an individual and that is associated with present distress or disability or with a significantly increased risk of suffering death, pain, disability, or an important loss of freedom that is identified in the DSM-IV-TR, (published by the American Psychiatric Association). “Mental-health disorder” includes gambling disorders.

(4) “Non-treatment compliance monitoring,” means the non-medical, non-therapeutic services employed by the vendor to track and report the licensee’s compliance with the monitoring agreement.

(5) “Substance Abuse Disorder” means a disorder related to the taking of a drug of abuse including alcohol, to the side effects of a medication, and to a toxin exposure. The disorders include: substance abuse disorders such as substance dependence and substance abuse, and substance-induced disorders, including substance intoxication, withdrawal, delirium, and dementia, as well as substance induced psychotic disorder, mood disorder, etc, as defined in DSM-IV-TR, (published by the American Psychiatric Association) criteria.

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 676.200

Hist.: BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10; BP 12-2010, f. & cert. ef. 12-23-10

855-011-0020

Participation in Health Professional’s Service Program

(1) Effective July 1, 2010, the Oregon Board of Pharmacy (Board) will participate in the Program.

(2) The Board may only refer licensees of the Board to the Program if they meet the referral criteria established by the Board.

(3) The Board may refer a licensee to the Program in lieu of or in addition to public discipline.

(4) A licensee who has not been referred to the Program by the Board may participate in the Program as permitted by ORS 676.190(5). Licensees may not refer themselves to the Program unless they certify that, to the best of their knowledge, they are not currently under investigation by the Board.

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 676.200

Hist.: BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10; BP 12-2010, f. & cert. ef. 12-23-10

855-011-0030

Procedure to refer Board licensees to the Program

(1) When the Board has information that a licensee may be impaired by alcohol or a substance abuse disorder or dependency, or a mental-health disorder, the Board may consider referring the licensee to the Program.

(2) Before the Board refers a licensee to the Program, the Board shall:

(a) Obtain a copy of a written report that diagnoses the licensee with alcohol or a substance abuse disorder or dependency, or a mental-health disorder and provides treatment options;

(b) Investigate to determine whether the licensee’s professional practice while impaired has presented or presents a danger to the public;

(c) Obtain the licensee’s written agreement to report any arrest for or conviction of a misdemeanor or felony to the Board within three business days after the licensee is arrested or convicted;

(d) Obtain the licensee’s written agreement to pay the costs of participation in the Program, including the cost of laboratory or toxicology tests, treatment, consultation group meetings and evaluations; and

(e) Obtain the licensee’s written consent allowing disclosure and exchange of information between the Program, the Board, the monitoring entity, the licensee’s employers, and evaluators and treatment entities.

(3) The report referred to in subsection (2)(a) of this rule must be prepared by an independent evaluator approved by the Board under OAR 855-011-0040 to evaluate alcohol or a substance abuse disorder or dependency, and mental-health disorders.

(4) The Board may only refer to the Program a licensee who has been diagnosed with alcohol or a substance abuse disorder or dependency, or a mental health disorder.

(5) The Board will consider all relevant factors before determining whether to refer a licensee to the Program. Relevant factors shall include but are not limited to:

(a) Licensee’s disciplinary history;

(b) The severity and duration of the licensee’s impairment;

(d) The likelihood that licensee’s impairment can be managed with treatment; and

(e) The likelihood that the licensee will follow the conditions of the program.

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 676.200

Hist.: BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10; BP 12-2010, f. & cert. ef. 12-23-10

855-011-0040

Approval by the Board of an Independent Evaluator

(1) The Board may approve a person to act as an evaluator provided that the person:

(a) Is licensed as required by the jurisdiction in which they work;

(b) Possesses a master’s degree or a doctorate in a mental health discipline;

(A) US Department of Transportation, Substance Abuse Professional Qualification training;

(B) Certification by the National Association of Alcoholism and Drug Abuse Counselors Certification Commission as a Certified Alcohol and Drug Abuse Counselor (CADC) level II or III; or

(C) Board certification in Addiction Medicine by either the American Society of Addiction Medicine or American Board of Psychiatry and Neurology.

(d) Is able to provide a multi-disciplinary assessment and written report describing a licensee’s diagnosis, degree of impairment and treatment options; and

(e) Certifies that, if required, they are willing to defend their evaluation in a court of law.

(2) The Board may not approve an evaluator in a case if, in the Board’s judgment, the evaluator’s judgment is likely to be influenced by a personal or professional relationship with a licensee.

(3) The Board shall maintain a list of approved independent evaluators on the Board’s website or the Board may approve a list of evaluators that meet the above criteria that is approved and published by the Program contractor.

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 676.200

Hist.: BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10; BP 12-2010, f. & cert. ef. 12-23-10

855-011-0050

Additional requirements for licensees referred to the Program

(1) In addition to the requirements established by ORS 676.185 to 676.200, a licensee who participates in the Program must:

(a) Participate in the Program for as long as specified in the disciplinary order but not less than two years, except that a licensee who has been enrolled in a prior Board approved program for at least two years may count up to one year of that program towards this requirement;

(b) Meet all conditions of probation specified in the disciplinary order; and

(2) A licensee may petition the Board for early removal from the Program if:

(a) They are in good standing with the Program;

(b) They have been in the Program for at least two years; and

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 676.200

Hist.: BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10; BP 12-2010, f. & cert. ef. 12-23-10

855-021-0010

Continuing Pharmacy Education

(1) In this rule the terms below have the meanings given:

(a) “Patient Safety” means procedures and processes that ensure that the correct patient receives the correct drug in the correct dose, and is counseled appropriately.

(b) “Medication error reduction” means procedures and processes to reduce and avoid adverse events and to ensure that the correct patient receives the correct drug in the correct dose.

(2) A continuing pharmacy education program means classes of post graduate studies, informal study group participation, institutes, seminars, lectures, conferences, workshops, extension study, correspondence courses, teaching, planned and professional meetings, self study courses, cassette or audio visual tape/slides or materials, and other self instruction units:

(a) A program shall consist of therapeutics, or pharmacy and drug law or other aspects of health care. At least one hour of continuing education credit must be earned in the area of pharmacy and drug law. Effective from June 1, 2011, at least one hour of continuing education credit must be earned in the area of patient safety or medication error reduction.

(b) Programs shall provide for examinations or other methods of evaluation to assure satisfactory completion by participants.

(c) The person or persons who are to instruct or who are responsible for the delivery or content of the program shall be qualified in the subject matter by education and experience.

(3) Continuing pharmacy education programs shall be approved by the Board of Pharmacy. Application for approval shall be made on and in accordance with forms established by the Board. The forms shall require information relating to:

(a) Name of provider or sponsor;

(b) Type of program offered;

(d) Number of contact hours offered;

(e) Total number of contact hours in therapeutics or pharmacy and drug law or other aspects of health care;

(f) Method of determining satisfactory completion of program;

(g) Dates and location of program;

(h) Name and qualification of instructors or other persons responsible for the delivery or content of the program.

(4) CE programs are not required to carry approval of American Council on Pharmaceutical Education (ACPE). Programs presented by providers approved by the American Council on Pharmacy Education (ACPE) are generally accepted, however, the Board reserves the right to determine the number of hours allowed or to disapprove such programs.

(5) Providers shall provide attendees with proof of attendance that shows the date and number of contact hours provided. Providers must maintain attendance lists for three years.

(6) Continuing pharmacy education credit accumulated in excess of the required 15 contact hours for annual license renewal cannot be carried forward.

(7) A maximum of 10 hours (1.0 CEU) may be earned in any licensing year by preparing and presenting CE programs. Pharmacists presenting CE programs may earn one hour (0.1 CEU) for preparation time of one hour or more, plus credit for the actual contact hour time of the presentation. A pharmacist must show content of the course, and a description of the intended audience (e.g., pharmacists, physicians, nurses). Public service programs, such as presentations to school children or service clubs, are not eligible for continuing education credit.

(8) Pharmacists taking post graduate studies applicable to graduate or professional degrees may submit the course syllabus and evidence of satisfactory completion of the course for continuing education credit approval by the Board.

(9) The Board may approve up to 14 (fourteen) hours of CE credit for licensees who have successfully completed Disease State Management courses certified by the NIPCO, NISPC, BPST, or other appropriate certified programs sponsored by established credentialing groups.

(10) Board members or staff may attend CE programs for the purpose of evaluating content, format and appropriateness of material for Continuing Pharmacy Education credit. Subsequent programs by CE providers whose current programs are deemed deficient by on-site evaluation may be required to obtain prior approval by the Board. The Board will provide feedback to CE providers regarding evaluated CE presentations.

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.285

Hist.: 1PB 45, f. & ef. 7-6-76; 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 2-1984, f. & ef. 3-7-84; 1PB 1-1986, f. & ef. 6-5-86; PB 10-1987, f. & ef. 12-8-87; PB 3-1991, f. & cert. ef. 9-19-91; PB 4-1992, f. & cert. ef. 8-25-92; BP 5-2000(Temp), f. 6-20-00, cert. ef. 6-20-00 thru 10-27-00; Administrative correction 6-21-01; BP 2-2004, f. 5-21-04 cert. ef. 6-1-04; BP 12-2010, f. & cert. ef. 12-23-10

855-041-0065

Requirements for Prescriptions — Prescription Refills

Prescriptions, prescription refills, and drug orders must be correctly dispensed in accordance with the prescribing practitioner’s authorization. When a prescription is transmitted orally, both the receiving pharmacist’s name or initials and the name of the person transmitting must be noted on the prescription.

(1) Each pharmacy must document the following information:

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

(b) The full name and, in the case of controlled substances, the address and the Drug Enforcement Administration registration number of the practitioner or other number as authorized under rules adopted by reference under rule OAR 855-080-0085;

(d) The name, strength, dosage forms of the substance, quantity prescribed and, if different from the quantity prescribed, the quantity dispensed;

(e) The directions for use, if given by the practitioner;

(f) The date of filling, and the total number of refills authorized by the prescribing practitioner; and

(2) In accordance with ORS 689.515(3), a practitioner may specify in writing, by a telephonic communication or by electronic transmission that there may be no substitution for the specified brand name drug in a prescription.

(a) For a hard copy prescription issued in writing or a prescription orally communicated over the telephone, this instruction may use any one of the following phrases or notations:

(A) No substitution;

(B) N.S.;

(D) Brand necessary;

(E) Medically necessary;

(F) D.A.W. (Dispense As Written); or

(G) Words with similar meaning.

(b) For an electronically transmitted prescription, the prescriber or prescriber’s agent shall clearly indicate substitution instructions by way of the text (without quotes) “brand medically necessary” or words with similar meaning, in the electronic prescription drug order, as well as all relevant electronic indicators sent as part of the electronic prescription transmission.

(3) Where refill authority is given other than by the original prescription, documentation that such refill authorization was given, the date of authorization, and name of the authorizing prescriber or the prescriber’s agent must be recorded. This documentation must be readily retrievable. Prescriptions for controlled substances in Schedules III and IV are limited to five refills or six months from date of issue, whichever comes first.

(4) If the practitioner is not available and in the professional judgment of the pharmacist an emergency need for the refill of a prescription drug has been demonstrated, the pharmacist may dispense a sufficient quantity of the drug consistent with the dosage regimen, provided it is not a controlled substance, to last until a practitioner can be contacted for authorization, but not to exceed a 72-hour supply. The practitioner shall be promptly notified of the emergency refill.

(5) Each refilling of a prescription must be accurately documented, readily retrievable, and uniformly maintained for three years. This record must include.

(a) The identity of the responsible pharmacist;

(b) Name of the patient;

(d) Date of refill; and

(e) Quantity dispensed.

(6) After two years from date of issue, a prescription for a non-controlled substance becomes invalid and must be re-authorized by the prescriber. When used alone as a prescription refill designation the abbreviation, “PRN” for a non-controlled substance means that the medication can be refilled in proper context for a period of one year. When this abbreviation is used alone as a means to authorize refills for a controlled substance, the medication can be refilled in proper context for a period of six months or five refills, whichever comes first. When this abbreviation is used in conjunction with a definite time period, or a specific number of refills, the non-controlled medication can be refilled in proper context for a period not to exceed two years. The prescription shall not be refilled out of context with the approximate dosage schedule unless specifically authorized by the prescriber. A “non-controlled substance” means those drugs defined as “legend” pursuant to ORS 689.005(29) but does not include those drugs or substances controlled under the jurisdiction of the United States Department of Justice Drug Enforcement Administration.

(7) Prescriptions must be labeled with the following information:

(a) Name, address and telephone number of the pharmacy;

(b) Date;

(d) Name of patient;

(e) Name of drug, strength, and quantity dispensed; when a generic name is used, the label shall also contain the name of the manufacturer or distributor;

(f) Directions for use by the patient;

(g) Name of practitioner;

(h) Required precautionary information regarding controlled substances;

(i) Such other and further accessory cautionary information as required for patient safety;

(j) An expiration date after which the patient should not use the drug or medicine. Expiration dates on prescriptions must be the same as that on the original container unless, in the pharmacist’s professional judgment, a shorter expiration date is warranted. Any drug bearing an expiration date shall not be dispensed beyond the said expiration date of the drug; and

(k) Any dispensed prescription medication, other than those in unit dose or unit of use packaging, shall be labeled with its physical description, including any identification code that may appear on tablets and capsules.

(8) Upon written request and for good cause, the Board may waive any of the requirements of this rule. 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 689.505 & 689.515

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; 1PB 1-1986, f. & ef. 6-5-86; PB 8-1987, f. & ef. 9-30-87; PB 10-1989, f. & cert. ef. 7-20-89; PB 1-1991, f. & cert. ef. 1-24-91; PB 4-1991, f. & cert. ef. 9-19-91; PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92); PB 4-1992, f. & cert. ef. 8-25-92; PB 1-1995, f. & cert. ef. 4-27-95; PB 1-1996, f. & cert. ef. 4-5-96; PB 3-1997(Temp), f. & cert. ef. 11-12-97; BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98; BP 2-1998, f. & cert. ef. 3-23-98; BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00; BP 2-2000, f. & cert. ef. 2-16-00; BP 3-2000, f. & cert. ef. 2-16-00; BP 6-2000, f. & cert. ef. 6-29-00; BP 1-2002, f. & cert. ef. 1-8-02; BP 1-2003, f. & cert. ef. 1-14-03; BP 12-2010, f. & cert. ef. 12-23-10

Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2010.