Chapter 4723-9 Prescriptive Authority

4723-9-01 Definitions.

For purposes of this chapter the following definitions shall apply:

(A) "Certificate to prescribe" means the certificate issued by the board that authorizes the holder of the certificate to prescribe drugs and therapeutic devices in collaboration with one or more physicians or podiatrists.

(B) "Collaboration or collaborating" means in the case of a certified nurse practitioner, a clinical nurse specialist or a certified nurse-midwife, that a physician has entered into a standard care arrangement with the nurse and is continuously available to communicate with the nurse either in person, or by radio, telephone, or other form of telecommunication.

(C) "Consultation" means the discussion or communication between a nurse holding a current valid certificate to prescribe with a physician prior to initiating the prescription for a drug. The consultation relative to drug therapy shall be documented in the patient's record and shall include the consulting physician's name and the date the consultation took place.

(D) "Controlled substance" means a drug, compound, mixture, preparation, or substance included in schedule I, II, III, IV, or V pursuant to the provisions of Chapter 3719. of the Revised Code.

(E) "Contact hour" means a minimum of sixty minutes of continuing education. For credit hours earned on an academic quarter system, one credit hour is equivalent to ten contact hours. For credit hours earned on an academic trimester system, one credit hour is equivalent to twelve contact hours. For credit hours earned on an academic semester system, one credit hour is equivalent to fifteen contact hours.

(F) "Course of study" means an advanced level instructional program in pharmacology which consists of planned classroom and clinical study that is either:

(1) Offered by an accredited educational institution acceptable to the board. Accredited educational institutions acceptable to the board include programs that are required to obtain approval, authorization, or accreditation from one of the following:

(a) The Ohio board of regents under section 3333.07 of the Revised Code;

(b) The Ohio department of education under section 3313.90 of the Revised Code;

(c) The Ohio state board of career colleges and schools under section 3332.05 of the Revised Code;

(d) The higher learning commission of the north central association of colleges and schools;

(e) The accrediting council for independent colleges and schools; or

(f) Any other national or regional post-secondary education accreditation entity recognized by the board; or

(2) A continuing education course that meets the requirements of Chapter 4723-14 of the Administrative Code.

(G) "Externship" means the practice relationship, consistent with the standard care arrangement, between a nurse who holds a current, valid externship certificate to prescribe and one or more licensed physicians during which time the nurse's prescribing activities are reviewed and evaluated by a supervising professional for the purpose of ongoing improvement of the nurse's competence, knowledge, and skill in pharmacokinetic principles and the application of these principles to the nurse's area of practice.

(H) "Externship certificate to prescribe" means the certificate issued by the board that authorizes the holder of the certificate to prescribe drugs and therapeutic devices only when one or more supervising professionals are providing supervision in accordance with rule 4723-9-04 of the Administrative Code.

(I) "Jurisdiction" means any state, territory, or political subdivision of the United States in which a board or legal approving authority regulates nurse licensure and nursing practice and maintains membership in the national council of state boards of nursing.

(J) "Physician" means an individual who holds a current valid license to practice medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery issued by the Ohio state medical board, or, in the case of applicants who hold a current valid certificate of authority to prescribe drugs and therapeutic devices from another jurisdiction, or who have been employed by the United States government and authorized to prescribe in conjunction with that employment, the physician's license may be issued by another jurisdiction as defined in this chapter.

(K) "Successful completion of an externship" means the demonstration of the required hours of an externship experience and an attestation by a supervising physician to the competence of the nurse to hold a certificate to prescribe.

(L) "Supervising professional" means a physician or a nurse who is authorized by the board of nursing to prescribe and who has a standard care arrangement with the supervising physician. A holder of an externship certificate to prescribe shall not be a supervising professional.

(M) "Supervision" means the oversight of the prescribing practices of a nurse as a holder of an externship certificate to prescribe.

(1) "Direct supervision" means the supervising professional is available on site.

(2) "Indirect supervision" means the timely review by a physician of prescriptions written by and prescribing practices of a nurse holding an externship certificate to prescribe.

(N) "Types of drugs" means therapeutic drug class.

Effective: 11/05/2012
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.48 , 4723.49 , 4723.50
Prior Effective Dates: 10/01/2001, 02/01/2002, 02/01/2006, 02/01/2011

4723-9-02 Requirements for a course of study in advanced pharmacology.

(A) To be acceptable to the board, a course of study shall meet the following requirements:

(1) Be a minimum of forty-five contact hours in length and include content which ensures sufficient preparation for the safe and effective prescribing of drugs and therapeutic devices;

(2) Include content which is specific to the participant's nursing specialty and which includes all of the following:

(a) A minimum of thirty-six hours of training, obtained from a single provider, in:

(i) Pharmacokinetic principles and clinical application; and

(ii) Principles of the use of drugs and therapeutic devices in the prevention of illness and maintenance of health;

(b) A combined six hours of instruction in:

(i) The fiscal and ethical implications of prescribing drugs and therapeutic devices; and

(ii) The state and federal laws that apply to the authority to prescribe;

(c) Six hours of instruction that is specific to schedule II controlled substances, including instruction in all of the following:

(i) Indications and contraindications for the use of schedule II controlled substances in drug therapies, including risk, evaluation and mitigation strategies for the use of opiates in the treatment of chronic pain for non-terminal conditions, and the need for periodic assessment and documentation of the patient's functional status;

(ii) The most recent guidelines and recommendations for pain management therapies and education, as established by state and national organizations such as the Ohio pain initiative, the American pain society and the United States food and drug administration (FDA);

(iii) The most recent guidelines and recommendations for stimulant therapies utilized in the management of attention-deficit or hyperactivity disorder, as adopted by state and national organizations such as the American academy of pediatrics;

(iv) Fiscal and ethical implications of prescribing schedule II controlled substances;

(v) State and federal laws that apply to the authority to prescribe schedule II controlled substances, including state medical board of Ohio rules governing controlled substances and the treatment of chronic pain, and Ohio state board of pharmacy rules governing the manner of issuance of a prescription;

(vi) Prevention of abuse and diversion of schedule II controlled substances, including identification of the risk of abuse, addiction and diversion, recognition of abuse, addiction and diversion, types of assistance available for prevention of abuse, addiction and diversion, the use of the Ohio automated rx reporting system (OARRS), and other methods of establishing safeguards against abuse and diversion; and

(d) Up to three hours of instruction specific to schedule II controlled substances as set forth in paragraphs (A)(2)(c)(iii) and (A)(2)(c)(iv) of this rule may be credited toward satisfying the six hours of instruction required by paragraphs (A)(2)(b)(i) and (A)(2)(b)(ii) of this rule.

(3) Include a process for interaction of the participants with instructional personnel;

(4) Include a process for evaluating the participants' learning of the content required by this rule that includes:

(a) Successful completion of case studies or written assignments;

(b) Successful completion of a comprehensive written examination;

(c) A mechanism to assure the security of the evaluation process; and

(5) Be faculty-directed and obtained either from:

(a) An accredited educational institution acceptable to the board; or

(b) A continuing education program in pharmacology that meets the requirements of Chapter 4723-14 of the Administrative Code.

Effective: 11/05/2012
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.482
Prior Effective Dates: 10/01/2001, 02/01/2002, 02/01/2003, 04/01/2006, 02/01/2011

4723-9-03 Completing a course of study in advanced pharmacology.

(A) Applicants seeking a certificate to prescribe, who do not meet the requirements set forth in either division (C) or (D) of section 4723.482 of the Revised Code, shall complete, within the three years immediately preceding the application, a course of study, as defined in rule 4723-9-01 of the Administrative Code, that meets the requirements of rule 4723-9-02 of the Administrative Code.

Effective: 02/01/2011
R.C. 119.032 review dates: 10/08/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.482
Prior Effective Dates: 10/01/2001, 02/01/2003, 02/01/2006

4723-9-04 Externship experience.

(A) In order to participate in an externship as defined in paragraph (G) of rule 4723-9-01 of the Administrative Code, a nurse shall:

(1) Meet the requirements set forth in section 4723.482 of the Revised Code; and

(2) Hold a current, valid externship certificate to prescribe issued by the board.

(B) Applicants for a certificate to prescribe who meet the requirements set forth in division (C) of section 4723.482 of the Revised Code are not required to participate in an externship in order to obtain a certificate to prescribe.

(C) Applicants for a certificate to prescribe who meet the requirements set forth in division (D) of section 4723.482 of the Revised Code must do the following to successfully complete an externship in order to obtain a certificate to prescribe:

(1) Complete a minimum of five hundred hours of prescribing practice during which the nurse's practice is directly supervised, as defined in paragraph (M)(1) of rule 4723-9-01 of the Administrative Code, by a supervising professional. When the supervising professional is a nurse, the nurse shall provide no more than two hundred of the five hundred hours of supervision; and

(2) Complete a two-hour course of instruction approved by the board in the laws of this state that govern drugs and prescriptive authority, as set forth in rule 4723-9-11 of the Administrative Code.

(D) Applicants for a certificate to prescribe that do not meet the requirements set forth in either division (C) or (D) of section 4723.482 of the Revised Code, in order to successfully complete an externship to obtain a certificate to prescribe, must complete a minimum of one thousand five hundred hours during which the nurse's prescribing practices shall be supervised as follows:

(1) For a minimum of five hundred hours, direct supervision, as defined in paragraph (M) of rule 4723-9-01 of the Administrative Code, shall be provided by a supervising professional. When the supervising professional is a nurse, the nurse shall provided no more than two hundred of the five hundred hours of supervision; and

(2) For the remaining hours, indirect supervision, as defined in paragraph (M)(2) of rule 4723-9-01 of the Administrative Code, shall be provided by a physician.

(E) In all externships, the standard care arrangement entered into between the collaborating physician and the nurse shall specify the frequency of the review needed for appropriate oversight, and shall otherwise comply with the requirements of Chapter 4723-8 of the Administrative Code.

Replaces: Replaces former 4723-9-04

Effective: 02/01/2011
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.48 , 4723.482 , 4723.484
Prior Effective Dates: 02/01/2002, 02/01/2003, 02/01/2006, 02/01/2009

4723-9-05 Standards and procedures for obtaining an externship certificate to prescribe.

(A) Applicants seeking an externship certificate, in accordance with division (A) of section 4723.482 of the Revised Code, to prescribe as a certified nurse-midwife, certified nurse practitioner, or clinical nurse specialist shall submit:

(1) A completed application on the form required by the board, located athttp://www.nursing.ohio.gov/forms.htm (revised October 2013), that includes evidence of having successfully completed the advanced pharmacology course as set forth in rule 4723-9-03 of the Administrative Code;

(2) Evidence of holding both a current, valid license to practice nursing as a registered nurse and a current, valid certificate of authority issued under section 4723.41 of the Revised Code to practice as a certified nurse-midwife, certified nurse practitioner, or clinical nurse specialist;

(3) Documentation of a collaborative practice with a supervising physician who has agreed to the practice agreement; and

(4) An application fee of fifty dollars.

(B) Applicants seeking an externship certificate, according to division (D) of section 4723.482 of the Revised Code, to prescribe as a certified nurse-midwife, certified nurse practitioner, or clinical nurse specialist shall submit a completed application on the form required by the board, located at http://www.nursing.ohio.gov/forms.htm (revised October 2013), that includes:

(1) Documentation satisfactory to the board of:

(a) Having held, for a continuous period of at least one year during the three years immediately preceding the date of application, valid authority issued by another jurisdiction to prescribe therapeutic devices and drugs, excluding controlled substances; or

(b) Having been employed by the United States government and authorized, for a continuous period of at least one year during the three years immediately preceding the date of application, to prescribe therapeutic devices and drugs, excluding controlled substances, in conjunction with that employment;

(2) Verification of both a current, valid license to practice nursing as a registered nurse and a current, valid certificate of authority issued by another jurisdiction to practice as a certified nurse-midwife, certified nurse practitioner, or clinical nurse specialist;

(3) Documentation of a collaborative practice with a supervising physician who has agreed to the practice agreement; and

(4) An application fee of fifty dollars.

(C) The externship certificate to prescribe shall be considered current for one year following issuance of the certificate by the board unless the certificate is suspended or revoked by the board.

(D) An externship certificate to prescribe may be extended for an additional two years if the nurse submits evidence satisfactory to the board of continued participation in an externship as set forth in rule 4723-9-04 of the Administrative Code.

Effective: 02/01/2014
R.C. 119.032 review dates: 10/15/2015
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.48 , 4723.482 , 4723.484
Prior Effective Dates: 10/01/2001, 02/01/2002, 02/01/2006, 02/01/2011

4723-9-06 Standards and procedures for obtaining an initial certificate to prescribe.

(A) Except as provided in paragraph (B) of this rule, to obtain a certificate to prescribe a certified nurse-midwife, certified nurse practitioner, or clinical nurse specialist, who meets the qualifications set forth in section 4723.482 of the Revised Code and this chapter shall:

(1) Submit a completed application on the form required by the board, located at http://www.nursing.ohio.gov/forms.htm (revised October 2013), that includes documentation satisfactory to the board of:

(a) Having successfully completed the advanced pharmacology course of study as set forth in rule 4723-9-03 of the Administrative Code, except this course is not required for applicants who are seeking prescriptive authority according to division (D) of section 4723.482 of the Revised Code; or

(b) Having held authority to prescribe as an advanced practice registered nurse under section 4723.56 of the Revised Code on May 17, 2000;

(2) Provide verification of holding both a current, valid license to practice nursing as a registered nurse and a current, valid certificate of authority issued under section 4723.41 of the Revised Code to practice as a certified nurse-midwife, certified nurse practitioner, or clinical nurse specialist;

(3) Submit documentation satisfactory to the board of either:

(a) Having completed the externship required by rule 4723-9-04 of the Administrative Code which includes a statement from a supervising physician attesting to the applicant's successful completion of the externship; or

(b) Having held authority to practice as an advanced practice registered nurse under section 4723.56 of the Revised Code on May 17, 2000; and

(4) Submit an application fee of fifty dollars.

(B) Applicants seeking a certificate, in accordance with division (C) of section 4723.482 of the Revised Code, to prescribe as a certified nurse-midwife, certified nurse practitioner, or clinical nurse specialist shall submit a completed application on the form required by the board, located athttp://www.nursing.ohio.gov/forms.htm (revised October 2013), that includes:

(1) Documentation satisfactory to the board of:

(a) Having held, for a continuous period of at least one year during the three years immediately preceding the date of application, valid authority issued by another jurisdiction to prescribe therapeutic devices and drugs, including at least some controlled substances; or

(b) Having been employed by the United States government an authorized, for a continuous period of at least one year during the three years immediately preceding the date of application, to prescribe therapeutic devices and drugs, including at least some controlled substances, in conjunction with that employment;

(2) Documentation satisfactory to the board of completion of a two-hour course of instruction approved by the board in the laws of this state that govern drugs and prescriptive authority, as set forth in rule 4723-9-11 of the Administrative Code;

(3) Verification of both a current, valid license to practice nursing as a registered nurse and a current, valid certificate of authority issued by another jurisdiction to practice as a certified nurse-midwife, certified nurse practitioner, or clinical nurse specialist; and

(4) An application fee of fifty dollars.

(C) If an applicant for a certificate to prescribe fails to meet the requirements for certification within one year from the date the application is received, or the application submitted to the board remains incomplete for one year, the application shall be considered void and the fee submitted with the application shall be forfeited. The application shall state the circumstances under which this forfeiture may occur.

(D) An initial certificate to prescribe is considered current until the next scheduled renewal period for registered nurse licensure. However, when a certificate to prescribe is issued by the board on or after March first of an odd numbered year, that certificate to prescribe shall be current through August thirty-first of the next odd numbered year.

(E) A certificate to prescribe shall be automatically suspended or revoked, according to division (B) of section 4723.47 of the Revised Code, when the holder's certificate of authority is suspended or revoked. If suspended, the certificate to prescribe shall remain suspended until the certificate of authority is reinstated. If a restriction is placed on the certificate of authority, the same restriction applies to the certificate to prescribe. A certificate to prescribe shall automatically lapse or become inactive, according to division (B) of section 4723.47 of the Revised Code, when the certificate of authority is lapsed or made inactive. The certificate to prescribe shall remain lapsed or inactive until the certificate of authority is renewed or reactivated.

Effective: 02/01/2014
R.C. 119.032 review dates: 10/15/2015
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.47 , 4723.48 , 4723.482 , 4723.484 , 4723.50
Prior Effective Dates: 02/01/2002, 02/01/2006, 02/01/2010, 02/01/2011

4723-9-07 Certificate to prescribe renewal.

(A) To renew a certificate to prescribe, a certified nurse-midwife, certified nurse practitioner, or clinical nurse specialist who meets the qualifications set forth in sections 4723.24 and 4723.485 of the Revised Code shall submit:

(1) A completed renewal application on the form required by the board, located at http://www.nursing.ohio.gov/forms.htm (revised March 2013);

(2) Documentation satisfactory to the board of having completed during the previous two years at least twelve hours of additional continuing education in advanced pharmacology, which includes instruction that is specific to controlled substances, or, if the certificate has been held for less than a full renewal period, at least six hours of approved continuing education in pharmacology , which includes instruction specific to controlled substances; and

(3) A renewal fee of fifty dollars and all other applicable fees required by section 4723.08 of the Revised Code.

(B) A renewed certificate to prescribe shall be current until the next scheduled renewal period for registered nurse licensure.

(C) The board shall provide to each holder of a current, valid certificate to prescribe, an application for renewal of a certificate to prescribe, except when the board is aware that an individual is ineligible for renewal for any reason, including those reasons specified in division (A) of section 4723.24 of the Revised Code. Failure of the holder to receive an application for renewal from the board does not excuse the holder from the requirements of Chapter 4723. of the Revised Code and this chapter.

(D) A holder of a current valid certificate to prescribe who does not intend to prescribe drugs or therapeutic devices in Ohio may request that the certificate to prescribe be placed on inactive status:

(1) At time of renewal, by checking the appropriate box on the certificate to prescribe renewal application that indicates the holder wants to place the certificate on inactive status; or

(2) At any other time, by submitting to the board a written statement requesting that the certificate to prescribe be placed on inactive status.

(E) While on inactive status, a nurse shall not represent or imply to the public that the nurse is authorized to prescribe drugs or therapeutic devices.

(F) An inactive or lapsed certificate to prescribe may be reactivated or reinstated pursuant to a written request which shall be accompanied by:

(1) A completed certificate to prescribe renewal application on the form required by the board, located athttp://www.nursing.ohio.gov/forms.htm (revised March 2013); and

(2) Payment of the applicable fees set forth in section 4723.08 of the Revised Code.

(G) If the certificate to prescribe has lapsed or been placed on inactive status for three years or longer, the nurse seeking to reinstate or reactivate the certificate shall first obtain an externship certificate to prescribe and shall meet all requirements of externship including completion of the pharmacology course in accordance with rule 4723-9-03 of the Administrative Code. This requirement applies to all certificate holders, including those who originally obtained a certificate to prescribe according to division (C) or (D) of section 4723.482 of the Revised Code.

(H) A certificate holder whose certificate lapsed, due to the holder's service in the armed forces of the United States, or in the national guard or in a reserve component, shall be eligible for renewal and reinstatement without payment of the reinstatement fee required by division (A)(18) of section 4723.08 of the Revised Code, if the following are met:

(1) The certificate holder presents the board with satisfactory evidence that, not more than six months prior to the date the evidence is submitted to the board, the certificate holder was honorably discharged or separated under honorable conditions;

(2) The certificate holder is not suffering a mental or physical impairment that may affect the individual's ability to provide safe care; and

(3) The certificate holder meets the requirements for certificate renewal required by this rule.

(I) A certificate holder whose certificate lapsed, due to the certificate holder's spouse's service in the armed forces of the United States, or in the national guard or in a reserve component, shall be eligible for renewal and reinstatement without payment of the reinstatement fee required by division (A)(18) of section 4723.08 of the Revised Code, if the following are met:

(1) The certificate holder presents the board with satisfactory evidence that the certificate holder did not renew their certificate because their spouse's military service caused them to be absent from the state of Ohio;

(2) The certificate holder presents the board satisfactory evidence that, not more than six months prior to the date the evidence is submitted to the board, the certificate holder's spouse was honorably discharged or separated under honorable conditions; and

(3) The certificate holder meets the requirements for renewal required by this rule.

Effective: 02/01/2014
R.C. 119.032 review dates: 10/15/2015
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.485
Prior Effective Dates: 02/01/2002, 02/01/2006, 02/01/2011, 11/05/2012

4723-9-08 Safety standards for personally furnishing drugs and therapeutic devices.

(A) In accordance with section 3719.81 of the Revised Code, a nurse who holds a current, valid certificate to prescribe issued by the board may personally furnish to a patient a sample of a drug or therapeutic device included among the types of drugs and devices set forth in the formulary established in rule 4723-9-10 of the Administrative Code, subject to all of the following:

(1) The amount of the sample furnished shall not exceed a seventy-two-hour supply, except when the minimum available quantity of the sample is packaged in an amount that is greater than a seventy-two-hour supply, in which case the nurse may furnish the sample in the packaged amount;

(2) Samples may not be sold as set forth in section 4729.01 of the Revised Code;

(3) Samples of controlled substances may not be personally furnished;

(4) Where the directions for use by a particular patient are different from the directions on or in the sample container, the nurse shall also provide, in written format, the following:

(a) The name of the prescribing nurse;

(b) The name of the patient; and

(c) Directions for use of the drug or therapeutic device; and

(5) The nurse shall maintain a written record of all drugs and devices personally furnished by the nurse.

(B) A nurse who holds a current, valid certificate to prescribe issued by the board may personally furnish to a patient a complete or partial supply of a drug or therapeutic device included in the types of drugs and devices listed on the formulary established in rule 4723-9-10 of the Administrative Code, subject to all of the following:

(1) Those drugs that may be personally furnished are limited to those set forth in section 4723.481 of the Revised Code;

(2) The nurse shall affix to the container a label showing:

(a) The name and address of the prescribing nurse;

(b) The name of the patient for whom the drug is intended;

(c) Name and strength of the drug;

(d) Directions for use; and

(e) Date furnished;

(3) The nurse shall maintain a written record of all drugs and devices personally furnished by the nurse; and

(4) The nurse may personally furnish the drug or device only in the locations set forth in section 4723.481 of the Revised Code.

(C) A nurse who personally furnishes a drug or therapeutic device shall do so only in accordance with this rule and any other applicable state or federal laws or rules relative to personally furnishing drugs and therapeutic devices, including, but not limited to, rules adopted by the Ohio board of pharmacy and rule 4723-9-12 of the Administrative Code regarding standards and procedures for review of OARRS reports.

Effective: 02/01/2012
R.C. 119.032 review dates: 10/15/2015
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.481
Prior Effective Dates: 2/1/2002, 02/01/2006, 02/01/2011

4723-9-09 Standards of prescribing for nurses with a certificate to prescribe.

(A) A nurse who holds a current valid certificate to prescribe may prescribe a drug or therapeutic device provided the prescription is in accordance with:

(1) The nurse's standard care arrangement;

(2) The scope of practice in the nurse's specialty area;

(3) The requirements of the formulary as set forth in section 4723.50 of the Revised Code; and

(4) The requirements of this chapter.

(B) The nurse's prescriptive authority shall not exceed the prescriptive authority of the collaborating physician, including but not limited to, any restrictions imposed on the physician's practice by action of the United States drug enforcement administration or the state medical board.

(C) A nurse who holds a current valid certificate to prescribe shall prescribe in a valid prescriber-patient relationship. This may include, but is not limited to:

(1) Obtaining a thorough history of the patient;

(2) Conducting a physical or mental examination of the patient;

(3) Rendering a diagnosis;

(4) Prescribing medication, ruling out the existence of any recognized contraindications;

(5) Consulting with the collaborating physician when necessary; and

(6) Properly documenting these steps in the patient's medical records.

(D) Acceptable and prevailing standards of safe nursing care require that a nurse maintain detached professional judgment in the treatment of family members.

(1) A nurse holding a current, valid certificate to prescribe shall not prescribe any drug or therapeutic device to family members unless:

(a) The nurse is able to exercise detached professional judgment in reaching diagnostic or therapeutic decisions;

(b) The prescription is in accordance with the nurse's scope of practice and standard care arrangements; and

(c) The prescription is documented in the patient's record.

(2) A nurse holding a current, valid certificate to prescribe shall not prescribe controlled substances for a family member.

(3) For the purposes of this rule, "family member" means a spouse, parent, child, sibling or other individual with respect to whom a nurse's personal or emotional involvement may render the nurse unable to exercise detached professional judgment in reaching diagnostic or therapeutic decisions.

(E) A nurse holding a current valid certificate to prescribe a controlled substance shall apply for, and obtain, the United States drug enforcement administration registration prior to prescribing any controlled substances, except if not required to do so as provided in rule 4729-17-13 of the Administrative Code.

(F) A nurse holding a current valid certificate to prescribe shall not prescribe any drug or device to perform or induce an abortion.

(G) All drugs and therapeutic devices shall be prescribed in accordance with the standard care arrangement and Chapter 4723. of the Revised Code and rules of the board.

(H) A nurse holding a current valid certificate to prescribe may prescribe drugs for purposes other than food and drug administration (FDA) indications when both of the following apply:

(1) The prescribing is in accordance with provisions of the formulary established pursuant to section 4723.50 of the Revised Code; and

(2) The prescribing is consistent with the standard care arrangement required by section 4723.431 of the Revised Code.

(I) A nurse holding a current valid certificate to prescribe shall satisfy all requirements for prescribing set forth in rule 4729-5-30 of the Administrative Code, and shall include the nurse's prescriber number on each prescription.

(J) A nurse holding a current, valid certificate to prescribe shall satisfy all the standards and procedures for review of OARRS reports as defined and set forth in rule 4723-9-12 of the Administrative Code.

(K) A nurse holding a current, valid certificate to prescribe shall not self-prescribe a controlled substance.

Effective: 02/01/2014
R.C. 119.032 review dates: 10/15/2013
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.481
Prior Effective Dates: 02/01/2002, 02/01/2003, 02/01/2006, 02/01/2011, 02/01/2012

4723-9-10 Formulary.

(A) The formulary, as established by the committee on prescriptive governance, shall be available on the Ohio board of nursing web site.

(B) The committee on prescriptive governance shall review the formulary for additions or deletions at least once a year.

(C) The committee on prescriptive governance shall establish a formulary and may exclude subtypes or individual drugs within the following types of drugs:

(1) Nutrients and nutritional agents;

(2) Hematological agents;

(3) Endocrine and metabolic agents;

(4) Cardiovascular agents;

(5) Renal and genitourinary agents;

(6) Respiratory agents;

(7) Central nervous system agents;

(8) Gastrointestinal agents;

(9) Anti-infective and systemic agents;

(10) Biologic/immunologic agents;

(11) Dermatologic agents;

(12) Opthalmic and otic agents;

(13) Antineoplastic agents; and

(14) Diagnostic aids.

(D) Except as provided in paragraph (D)(4) of this rule, a nurse with a current valid certificate to prescribe may prescribe a schedule II controlled substance only in situations where all of the following apply:

(1) A patient has a terminal condition, as defined in section 2133.01 of the Revised Code;

(2) The nurse's collaborating physician initially prescribed the substance for the patient; and

(3) The prescription is for a quantity that does not exceed the amount necessary for the patient's use in a single, twenty-four hour period.

(4) A nurse holding a current valid certificate to prescribe may prescribe a schedule II controlled substance, if authorized by the formulary, if the nurse issues the prescription to the patient from any of the following locations:

(a) A hospital registered under section 3701.07 of the Revised Code;

(b) An entity owned or controlled, in whole or in part, by a hospital or by an entity that owns or controls, in whole or in part, one or more hospitals;

(c) A health care facility operated by the department of mental health or the department of developmental disabilities;

(d) A nursing home licensed under section 3721.02 of the Revised Code or by a political subdivision certified under section 3721.09 of the Revised Code;

(e) A county home or district home operated under Chapter 5155. of the Revised Code that is certified under the medicare or medicaid program;

(f) A hospice care program, as defined in section 3712.01 of the Revised Code;

(g) A community mental health agency, as defined in section 5122.01 of the Revised Code;

(h) An ambulatory surgical facility, as defined in section 3702.30 of the Revised Code;

(i) A freestanding birthing center, as defined in section 3702.51 of the Revised Code;

(j) A federally qualified health center, as defined in section 3701.047 of the Revised Code;

(k) A federally qualified health center look-alike, as defined in section 3701.047 of the Revised Code;

(l) A health care office or facility operated by the board of health of a city or general health district or the authority having the duties of a board of health under section 3709.05 of the Revised Code; or

(m) A site where a medical practice is operated, but only if the practice is comprised of one or more physicians who also are owners of the practice; the practice is organized to provide direct patient care; and the clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner providing services at the site has a standard care arrangement and collaborates with at least one of the physician owners who practices primarily at that site.

(5) A nurse shall not issue to a patient a prescription for a schedule II controlled substance from a convenience care clinic even if the clinic is owned or operated by an entity specified in paragraph (D)(4) of this rule.

(E) A nurse holding a current valid certificate to prescribe may prescribe any drug or therapeutic device in any form and route of administration that is included on the formulary and as agreed to by the collaborating physician in the standard care arrangement. The ability to prescribe the drug or therapeutic device must be within the nurse's scope of practice.

(F) Drugs approved by the FDA subsequent to the date of the adoption of these rules shall not be prescribed until reviewed and approved by the committee on prescriptive governance.

(G) For purposes of interpreting the formulary, the following definitions shall apply:

(1) "Physician consultation" means a nurse holding a current, valid certificate to prescribe may initiate the medication after direct communication with the collaborating physician regarding a particular patient and documenting the consultation in the patient record. Once the medication is initially authorized by the collaborating physician, a nurse holding a current valid certificate to prescribe may continue, modify, or discontinue the medication without further consultation.

(2) "Physician initiation" means the collaborating physician is required to have personally examined and evaluated the patient before therapy is initiated in accordance with rule 4731-11-09 of the Administrative Code. Following discussion with the collaborating physician, the initial order or prescription may be written by an advanced practice nurse holding a current valid certificate to prescribe. Once therapy has been initiated, the advanced practice nurse may continue, modify, or discontinue the medication without further consultation.

Effective: 11/05/2012
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.49 , 4723.491 , 4723.492
Prior Effective Dates: 02/01/2002, 02/01/2003, 02/01/2006, 02/01/2008

4723-9-11 Course in Ohio law governing drugs and prescriptive authority.

(A) All applicants seeking a certificate to prescribe, in accordance with either division (C) of section 4723.482 of the Revised Code, or in accordance with division (D) of section 4723.482 of the Revised Code, are required to complete a two-hour course of instruction in the laws of this state that govern drugs and prescriptive authority. To meet this requirement, the course of instruction must:

(1) Include content and instruction on rules 4723-9-08 , 4723-9-09 , 4723-9-10, and 4723-9-12 of the Administrative Code;

(2) Be approved by the board, or by an OBN approver as defined in rule 4723-14-01 of the Administrative Code, or offered by an OBN approved provider unit, as defined in rule 4723-14-01 of the Administrative Code that is headquartered in the state of Ohio; and

(3) Be at minimum two hours in length.

(B) Applicants must submit documentation of successful completion to the board in the form of an original certificate, issued by the provider of the course of instruction that includes:

(1) Name of the attendee;

(2) Title of the program;

(3) Date of the program;

(4) Name and address of the provider and OBN approver number, if applicable; and

(5) Verification of completion of at least two hours of instruction, each of sixty minutes in duration.

Effective: 11/05/2012
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.482
Prior Effective Dates: 02/01/2011

4723-9-12 Standards and procedures for review of OARRS.

(A) For the purposes of this rule:

(1) "OARRS" means the Ohio automated RX reporting system established and maintained according to section 4729.75 of the Revised Code.

(2) "OARRS report" means a report of information related to a specified patient generated by the drug database established maintained by the state board of pharmacy pursuant to section 4729.75 of the Revised Code.

(3) "Protracted basis" means a period in excess of twelve continuous weeks.

(4) "Reported drugs" means all drugs listed in rule 4729-37-02 of the Administrative Code that are required to be reported to the drug database established and maintained according to section 4729.75 of the Revised Code, including:

(a) Controlled substance schedules II, III, IV, and V; and

(b) All dangerous drug products containing tramadol.

(B) In addition to the requirements set forth in rule 4723-9-08 and rule 4723-9-09 of the Administrative Code, if a nurse who holds a current valid certificate to prescribe believes, or has reason to believe, that a patient may be abusing or diverting drugs, the nurse shall use sound clinical judgment in determining whether or not a reported drug should be prescribed or personally furnished to the patient.

(1) In making this determination, the nurse shall not personally furnish or prescribe a reported drug without first reviewing a patient's OARRS report if the patient exhibits the following signs of drug abuse or diversion:

(a) Illegally selling drugs;

(b) Forging or altering a prescription;

(c) Stealing or borrowing reported drugs;

(d) Increasing the dosage of reported drugs in amounts that exceed the prescribed amount;

(e) Having a drug screen result that is inconsistent with the treatment plan or refusing to participate in a drug screen;

(f) Having been arrested, convicted, or received diversion, or intervention in lieu of conviction for a drug-related offense while under the nurse's care;

(g) Receiving reported drugs from multiple prescribers; or

(h) Having a family member, friend, law enforcement officer or health care professional express concern related to the patient's use of illegal or reported drugs.

(2) Other signs of possible abuse or diversion that may necessitate review of the patient's OARRS report include, but are not limited to the following:

(a) A known history of chemical abuse or dependency;

(b) Appearing impaired or overly sedated during an office visit or examination;

(c) Requesting reported drugs by specific name, street name, color, or identifying marks;

(d) Frequently requesting early refills of reported drugs;

(e) Frequently losing prescriptions for reported drugs;

(f) A history of illegal drug use;

(g) Sharing reported drugs with another person; or

(h) Recurring emergency department visits to obtain reported drugs.

(C) A nurse who holds a current valid certificate to prescribe and personally furnishes or prescribes a reported drug to a patient following review of an OARRS report under paragraph (B) of this rule, and determines, based on the OARRS report and indicia described in paragraph (B) of this rule that the patient may be misusing reported drugs, shall first consult with their collaborating physician prior to personally furnishing or prescribing a reported drug at the patient's next visit.

(D) Following review of OARRS report information, the nurse who holds a current valid certificate to prescribe shall document receipt and assessment of the information in the patient's record, including any consultation with the collaborating physician that occurred based on the OARRS report information or required by paragraph (C) of this rule.

(E) A nurse who holds a current valid certificate to prescribe and utilizes reported drugs to treat a patient on what the nurse has reason to believe will be a protracted basis shall, at minimum, review an OARRS report, and document receipt and assessment of the information in the patient's record:

(1) At the beginning of treatment; and

(2) At least once annually after treatment begins.

(F) In requesting OARRS reports according to this rule:

(1) Initial reports requested shall cover a time period of at least one year;

(2) Subsequent reports requested shall at minimum cover the period of time from the date of the last report reviewed to the present; and

(3) In the event an OARRS report is not immediately available, the nurse who holds a current valid certificate to prescribe shall document the response from the drug database in the patient record.

(G) Paragraph (E) of this rule does not apply to a hospice patient in a hospice care program as those terms are defined in section 3712.01 of the Revised Code.

Effective: 11/05/2012
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4723.50 , 4723.487
Rule Amplifies: 4723.50 , 4723.487
Prior Effective Dates: 03/19/2012

4723-9-13 Instruction specific to schedule II controlled substances.

(A) All clinical nurse specialists, certified nurse practitioners, and certified nurse-midwives, who hold a certificate to prescribe, including an externship certificate, prior to the effective date of this rule must obtain six contact hours of instruction specific to schedule II controlled substances on or before August 31, 2013 in order to be eligible to renew their certificate to prescribe, and present documentation satisfactory to the board of having completed the instruction.

(B) To meet this requirement, the course of instruction must:

(1) Include the following content:

(a) Indications and contraindications for the use of schedule II controlled substances in drug therapies, including risk, evaluation and mitigation strategies for the use of opiates in the treatment of chronic pain for non-terminal conditions, and the need for periodic assessment and documentation of the patient's functional status;

(b) The most recent guidelines and recommendations for pain management therapies and education, as established by state and national organizations such as the Ohio pain initiative, the American pain society and the United States food and drug administration (FDA);

(c) The most recent guidelines and recommendations for stimulant therapies utilized in the management of attention-deficit or hyperactivity disorder, as adopted by state and national organizations such as the American academy of pediatrics;

(d) Fiscal and ethical implications of prescribing schedule II controlled substances;

(e) State and federal laws that apply to the authority to prescribe schedule II controlled substances, including state medical board of Ohio rules governing controlled substances and the treatment of chronic pain, and Ohio state board of pharmacy rules governing the manner of issuance of a prescription; and

(f) Prevention of abuse and diversion of schedule II controlled substances, including identification of the risk of abuse, addiction and diversion, recognition of abuse, addiction and diversion, types of assistance available for prevention of abuse, addiction and diversion, the use of the Ohio automated rx reporting system (OARRS), and other methods of establishing safeguards against abuse and diversion;

(2) Meet the requirements of Chapter 4723-14 of the Administrative Code; and

(3) Be at minimum six hours in length.

(C) Applicants must submit documentation of successful completion to the board in the form of an original certificate, issued by the provider of the course of instruction that includes:

(1) Name of the attendee;

(2) Title of the program;

(3) Date of the program;

(4) Name and address of the provider and OBN approver number, if applicable;and

(5) Verification of completion of at least six hours each of sixty minutes in duration.

Effective: 11/05/2012
R.C. 119.032 review dates: 10/15/2015
Promulgated Under: 119.03
Statutory Authority: 4723.50 , 4723.487
Rule Amplifies: 4723.50 , 4723.487