Ohio Advanced Practice Nursing Law Standard Care Agreements (SCA) Certificate of Authority (COA) Certificate to Prescribe (CTP) DEA Prescriptive Authority Formulary State Laws Adult/Gero NP IV Jennifer Frost (modified subsequent authors: Nicolette Black & Rachel Oldham) (modified, original authors: Erik Anderson, June Mack, & Rebecca Neeley-Rollins)

Standard Care Arrangement Ohio Practice Agreements

Standard Care Agreement (SCA) Ohio Revised Code (ORC) 4723-8-04 Agreement between physician/podiatrist and CNP, CNM, or CNS that needs to be made before beginning practice A complete listing of all components that should be included in this agreement can be found at: http://www.codes.ohio.gov/oac/4723-8-04

SCA A standard care arrangement shall be in writing and include all of the following: 1. Signature of all collaborating physicians, date when the arrangement is executed, and the dates of when reviews shall take place (including the most recent review). 2. Contact information for the collaborating physician including phone numbers he/she can be reached at anytime. 3. A well defined scope of practice for the NP, including procedures, as described in ORC 4723.43, and the practice expectations for type and expected volume of patients. 4. A description of the scope of prescriptive practice.

SCA 5. Periodic review and re-approval of the SCA; review should occur at least annually. 6. Criteria for referral of a client by the CNP to a collaborating physician. 7. Process for chart review (ORC 4723-8-05) and procedure for the review of CNP initiated referrals and outcomes. 8. Discussion of the CNP’s yearly billing and reimbursement. 9. Include an agreement regarding the medical insurance reimbursement (i.e. “incident to” or independent contracting) (ORC 5111.02). 10. Plan for patient coverage in CNP or collaborating physician planned or unplanned absences. 11. Process for resolution of disputes regarding patient management. Other items to include.

SCA A new agreement should be initiated when the CNP is employed at a different setting and collaborates with a different physician. A copy of the SCA shall be on file at each site where the CNP practice. If a collaborating physician enters into a SCA with more than 3 advance practice nurses who hold certificate to prescribe, the MD shall not collaborate at the same time with more that 3 of the APN’s If a CNP is employed by a hospital the negotiation of a SCA must occur, but may be subject to approval by the medical staff and governing body of the hospital prior to implementation.

SCA The Ohio Board of Nursing (OBN) must be informed of the collaborating physician’s identity within 30 days of engaging in practice.

Certificate of Authority COA

Ohio Board of Nursing Requirements Licensed RN Verification of National Certification 2013 Approved certifying organizations can be found at http://www.nursecredentialing.org/Certification/VerifyCertification.aspx (ANCC) Completed COA application $100 non-refundable fee (Payable to “Treasurer, State of Ohio”) 2 x 2 Head shot-less than 1 yr old Notarized Affidavit-after application completion Verification of graduate degree-Form B must be sent from school directly to the Board of Nursing If not completed in 1 year, application is forfeited http://www.nursing.ohio.gov/forms.htm#RX Initial verification is FREE, subsequent is $ 40, Institutions pay $50

COA Application forms can be obtained from http://www.nursing.ohio.gov/forms.htm#RX PDF is 7 pages. Pages 1-5 are the application directions and application Make sure there is no missing information; otherwise, it will be returned to you and the whole process will be delayed Page 6 is Form A and must be completed by the applicant and sent to the Certifying body who will send it back to the OBN Page 7 is Form B must be filled out by the applicant, then the educational institution and sent directly to the OBN

COA Go to www.nursing.ohio.gov, click on verification, enter your name, and “pending” will be displayed until certification is issued

Certificate to Prescribe CTP

Applying for Certificate to Prescribe After certificate of authority is obtained, the CNP “shall file with the board of nursing a written application for a certificate to prescribe.” The board of nursing “shall issue a certificate to prescribe to each applicant who meets the requirements…” Ohio Revised Codes (ORC) 4723.482 & 4723.484

Applying for Certificate to Prescribe A completed application on a form specified by the board which includes evidence of having successfully completed the advanced pharmacology course as set forth in rule 4723-9-03 of the Administrative Code 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 Documentation of a collaborative practice with a supervising physician who has agreed to the practice agreement An application fee of fifty dollars. OAC 4723-9-05

Pharmacology Requirement Completion of 36 contact hours regarding pharmacokinetics, clinical application, and the use of medications from a single provider Training in the fiscal, legal, and ethical implications of prescribing. Instruction obtained no longer than 3 years prior to applying for a CTP-E. (amended rules in Chapters 4723-8 and 4723-9 ORC)

Applying for Certificate to Prescribe Forms may be accessed from http://www.nursing.ohio.gov/forms.htm Laws, definitions, and explanations of application process may be reviewed at http://codes.ohio.gov/orc/4723

Certificate to Prescribe- Externship (CTP-E) The initial certificate to prescribe is an externship certificate or CTP-E. With a CTP-E the CNP “may obtain experience in prescribing drugs and therapeutic devices by participating in an externship that evaluates the nurse’s competence, knowledge, and skill in pharmacokinetic principles and their clinical application to the specialty being practiced.” ORC 4723.48

CTP-E During the externship, the nurse may prescribe drugs and therapeutic devices only when one or more physicians are providing supervision Supervision is defined as the “oversight of the prescribing practices of a nurse as a holder of an externship certificate to prescribe.” A minimum of 1500 hours is required ORC4723-9-01

CTP-E 500 hours of direct supervision “Direct supervision” means the supervising professional is available on site. When the supervising professional is a nurse, the nurse shall provide no more than 250 hours of supervision 1000 hours of indirect supervision “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 OAC 4723-9-01

CTP-E The CTP-E is issued for one year An extension may be requested if more time is needed

Externship Requirement Once the externship requirements have been satisfied, Form E may be submitted to the Board of Nursing with documentation by the supervising physician.

Certificate to Prescribe (CTP) On receipt of the new certificate, the nurse may prescribe drugs and therapeutic devices in collaboration with one or more physicians or podiatrists

CTP Collaboration or collaborating: “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.” ORC 4723.48

Prescribing Medication Prescription of medications is directed by state formulary and standard care agreement. CNP may only prescribe within provider-patient relationship that must be documented in the patient’s medical record The APN’s prescriptive authority shall not exceed the prescriptive authority of the collaborating physician or podiatrist ORC 4723-9-09

Furnishing Medication The amount of the sample furnished shall not exceed a 72 hour supply, except when the minimum available quantity of the sample is packaged in an amount that is greater than a 72 hour supply – can then furnish the sample in the packaged amount If the directions for use are different than stated on the sample, the nurse has to provide in written format The name of the prescribing nurse The name of the patient Directions for use Maintain a written record of all drugs and devices personally furnished by the nurse ORC 4723-9-08

Drug Enforcement Agency DEA

Obtaining DEA number After CTP has been issued May apply online at www.deadiversion.usdoj.gov Fee of $551 for 3 years

Prescription of Controlled Substances Ohio law allows for NP prescription of schedule II-V controlled substances. The APN may prescribe a schedule II controlled substance, but shall not exceed the prescriptive authority of the collaborating physician or podiatrist. ORC 4723.481 & 3719.06

Schedule II Definition Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence. Examples of Schedule II narcotics include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®), oxycodone (OxyContin®, Percocet®), and fentanyl (Sublimaze®, Duragesic®). Other Schedule II narcotics include: morphine, opium, and codeine. Examples of Schedule II stimulants include: amphetamine (Dexedrine®, Adderall®), methamphetamine (Desoxyn®), and methylphenidate (Ritalin®). Other Schedule II substances include: amobarbital, glutethimide, and pentobarbital Examples of Schedule III narcotics include: combination products containing less than 15 milligrams of hydrocodone per dosage unit (Vicodin®)

Schedule II Substitute Senate Bill 83 (SB 83), which became law on June 8, 2012, expanded the scope of schedule II prescribing for Advanced Practice Nurses (APNs) who hold a certificate to prescribe (CTP), or certificate to prescribe externship (CTP-E). The Board of Nursing adopted rules, effective November 5, 2012, implementing the requirements of SB 83 related to continuing education for CTP holders, and the advanced pharmacology course of instruction for applicants, related to schedule II controlled substances.

Schedule II As of June 8, 2012, a CTP or CTP-E holder who is practicing in a location specified in the bill is no longer subject to the 24-hour supply restrictions in the pre-existing law governing an APN's authority to prescribe schedule II controlled substances. However, CTP and CTP-E holders who are not practicing in one of the specified locations must follow the restrictions: prescribing of schedule II controlled substances is limited to a 24- hour emergency supply of medications, prescribing to terminally ill patients with respect to whom the collaborating physician has previously prescribed the medication.

Schedule II The locations specified in law are as follows: (1) A hospital registered with the Department of Health; (2) 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; (3) A health care facility operated by the Department of Mental Health or the Department of Developmental Disabilities; (4) A nursing home licensed by the Department of Health or a political subdivision; (5) A county home or district home that is certified under the Medicare or Medicaid program; (6) A hospice care program; (7) A community mental health facility;

Schedule II Locations continued: (8) An ambulatory surgical facility; (9) A freestanding birthing center; (10) A federally qualified health center; (11) A federally qualified health center look-alike; (12) A health care office or facility operated by a board of health or an authority having the duties of a board of health; (13) A site where a medical practice is operated, but only if the practice is comprised of one or more physicians who are also owners of the practice, the practice is organized to provide direct patient care, and the APN 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.

Prescription of Controlled Substances CTP or CTP-E holders are prohibited from prescribing a schedule II controlled substance from a convenience care clinic even if the clinic is owned or operated by an entity specified in the list above, with the exception of prescriptions limited to a 24-hour supply as set forth in pre-existing law.

Prescription of Controlled Substances No controlled substance shall be personally furnished to any patient. Each written prescription shall be properly executed, dated, and signed by the prescriber on the day when issued and shall bear the full name and address of the person for whom the controlled substance is prescribed and the full name, address, and registry number under the federal drug abuse control laws of the prescriber. ORC 3719.06

Continuing Education for Schedule II CTP holders are not required to complete the CE course prior to prescribing schedule IIs according to SB 83. However, all CTP holders must complete the CE no later than August 31, 2013. Section 4723.482, ORC, requires that a course of study in Advanced Pharmacology be “planned classroom and clinical instruction”, not independent study. The six-hours in schedule II controlled substances was added by SB 83 to the Advanced Pharmacology course. It must be part of planned classroom instruction rather than independent study.

Continuing Education for Schedule II The CE course must meet the Board’s requirements for continuing education, as specified in Rule 4723-14-05 (A), OAC. (For details, go to the Board website at www.nursing.ohio.gov and click on Law and Rules.) A list of OBN Approvers is located on the Board web site (click on Continuing Education). The Board itself will not provide this CE. Includes: pain management strategies, fiscal/ethical implications, state/federal laws, prevention of abuse: including identifying risk of abuse and diversion, recognizing risk and diversion, types of assistance available for preventing, methods of establishing safeguards.

Formulary

Formulary Developed by and reviewed/revised periodically by the Committee on Prescriptive Governance (CPG) Most current formulary and “Formulary Review/Revision” form available at http://www.nursing.ohio.gov/Practice.htm#AdvancedPractice in the Prescriptive Authority section Newest version is January 14, 2013

Committee on Prescriptive Governance (CPG) Members 1 CNP, 1 CNM, & 1 CNS with prescriptive authority 1 RN member of the Ohio Board of Nursing 2 physicians who collaborate with an APN 1 physician certified in Family Practice 1 physician member of the State Medical Board 1 pharmacist member of the Ohio Board of Pharmacy 1 clinical pharmacist

Formulary Additions/Revisions Any revisions to the formulary are made by the CPG Written recommendations/requests on a Formulary Review/Revision Form need to be sent to the board 30 days prior to a scheduled meeting via email/fax/or mail Each meeting focuses on the review of specific sections of the formulary Discuss issues related to prescriptive authority

APN Responsibility Drug Recalls Warnings and Safety Alerts Information for Patients http://www.fda.gov/oc/oha/default.htm **Know what you can and cannot prescribe and if physician initiation or consult is warranted!

Importance of Knowing the Prescribing Laws Can only prescribe formulary medications and must be a CTP or CTP-E holder. Can prescribe an approved drug in ANY form unless exclusion is specified. When prescribing combination medicines, each component must be in the CTP formulary. Not OK to RX a new indication until approved by CPG

Physician Initiated (PI) Physician must have previously examined/evaluated the patient the prescription is being written for. The APN may write the initial prescription after discussion with the physician. APN may start, change, or stop the medication without further consultation.

Physician Consultation (PC) APN may initiate a medication after physician communication and must document it in the patient record. Medication can then be continued, changed, or stopped by APN without further physician consultation.

Off Label Use May prescribe as long as: 1)The indication is supported by peer-reviewed research from a recognized body of knowledge. CTP/CTP-E holder must provide this information if requested OR 2)Outlined in the SCA and consistent with the formulary

Drug Review Requirement Continued treatment must be reviewed by the physician at the formulary directed time. SCA should include the review procedure and APN must document this in the patient record.

Drugs Requiring Review Initial 30 Day Review: -Glucocorticoids -Benzodiazepines: anti-anxiety -Lithium: also must be PI/PC -Centrally-acting and combination muscle relaxants 60 Day Review: -Atomoxetine: also must be PI/PC 6 Month Review: -Anti-parkinson agents Atomoxetine= Strattera/ ADHD

IV Medications IV forms of particular drugs that are identified in the formulary by an asterisk (* see footnote 1), require holding an advanced specialty certification as an Acute Care Nurse Practitioner, Acute Care Clinical Nurse Specialist, Neonatal Nurse Practitioner OR non-acute care CTP holders working in an institutional setting with PC.

IV Medications May prescribe as an Adult or Adult/Gero APN without PI/PC Many systemic anti-infectives: PCN, Quinolones, Flouroquinolones, Tetracyclines, Macrolides, Spectinomycin, Ketolides, Rifaximin, Clindamycin Amebicides, Rimatidine, Zanamivir, Oseltamavir Phosphate

Formulary Classifications (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. (15) Other

APNs Furnishing Samples Prescribers may furnish a sample of any drug or therapeutic device on the formulary with the following restrictions: The amount can not exceed a 72-hour supply except when the minimum quantity of the sample is packaged in an amount greater than a 72 hour supply [ex, OC] No charge may be imposed for the sample or furnishing it Samples of control substances shall not be furnished Prescribers can furnish a complete supply [from stock]: Only if employed by a health department, federally funded comprehensive primary care health clinic, or a nonprofit health care clinic/program Categories permitted: ATB, antifungals, scabicides, prenatal vitamins, contraceptives, and drugs/devices used in the treatment of HTN, DM, asthma, and dyslipidemia.

Legal Requirements If your RN licensure lapses, your COA is revoked; if your national certification lapses your COA is revoked … CTP is revoked It is a minor misdemeanor to prescribe with a lapsed license It is a felony to prescribe without a license Additional CEU is required to maintain the CTP 12 hours of approved advanced pharmacology over hours needed to maintain RN licensure (24 CEU RN, 1hour OH law) Approved Category D [identified with each program] Approved CEU activity by an agency which regulates a health care profession or discipline in OH or another jurisdiction CME Upon request must provide evidence – audit random

CTP # must be written on all RX RX Carolyn Sutter CNP Primary Care Clinic, Akron OH Phone ###, CTP### DATE_____ Name______________ DOB_______________ Address_____________ Allergies _______ RX Dispense____Refills_____ Signature_____________ ______________ DEA#_________________

Reference Lawwriter Ohio Laws and Rules (2012). 4273-8-04: Standard care arrangement for a certified nurse-midwife, certified nurse practitioner, and clinical nurse specialist. Retrieved on February 4, 2013 from http://codes.ohio.gov/oac/4723-8-04 Lawwriter Ohio Laws and Rules.(2012). Apply for certificate to prescribe. from http://codes.ohio.gov/orc/4723.48 Lawwriter Ohio Laws and Rules. (2012). Standards and procedures for approval as a certified nurse-midwife, certified nurse practitioner, certified registered nurse anesthetist, or clinical nurse specialist. Retrieved from http: //codes.ohio.gov./oac/4723-8-07 Ohio Board of Nursing. (2009). Advanced Practice. Retrieved on February 4, 2013 from http://www.nursing.ohio.gov/Practice.htm#AdvancedPractice Ohio Board of Nursing. (2013).Forms and Applications. Advanced Practice Nursing. Certificate of Authority Application Packet. Retrieved on February 4, 2013 from http://www.nursing.ohio.gov/forms.htm#RX Ohio Board of Nursing. (2013). Nursing Practice. Advanced Nursing Practice. Approved National Certifying Organizations. Retrieved from http://www.nursing.ohio.gov/Practice.htm#AdvancedPractice

References www.oaapn.org www.nursing.ohio.gov www.deadiversion.usdoj.gov

POP QUIZ DOES THE BOARD OF NURSING ISSUE A DEA NUMBER?

ANSWER NO An application can be found online at www.deadiversion.usdoj.gov and by clicking on drug registration

DO YOU INCLUDE CTP NUMBER ON PRESCRIPTIONS YOU WRITE?

ANSWER YES PRESCRIBER SHOULD INCLUDE CTP NUMBER

CAN CTP HOLDER PRESCRIBE SCHEDULE II DRUG?

YES, BUT ONLY IF: 1) The particular drug appear on the Formulary as Physician Initiated 2) The patient for the drug is prescribed has a terminal condition as defined in ORC 2133.01 3)MD initiated the medication 4)Prescribe less than 24 hour supply

CTP HOLDER PRESCRIBE FOR SELF?

NO.

CAN A MEDICAL ASSISTANT ADMINISTER A MEDICATION AS ORDERED BY A CTP HOLDER?

A NURSE MAY DELEGATE THE ADMINISTRATION OF ONLY: OTC TOPICAL MEDICATIONS TO BE APPLIED INTACT SKIN FOR PURPOSE OF IMPROVING SKIN CONDITION OR PROVIDING BARRIER; OTC EYE AND EAR DROPS; SUPPOSITORY MEDICATIONS; FOOT SOAK TREATMENTS, ENEMAS

All CNMs, CNSs and CNPs must have a SCA All CNMs, CNSs and CNPs must have a SCA. Only Psychiatric/ Mental Health CNSs who do not plan on prescribing are exempt from developing an SCA.

DOES THE STANDARD CARE ARRANGEMENT NEED TO BE FILED WITH THE OHIO BOARD OF NURSING?

No.  The Standard Care Arrangement must be kept on file at EACH practice site.  The SCA must be available at all times upon request by the Board of Nursing or other parties.  While the Board of Nursing has the right to review the SCA at any time for compliance, it does not need to approve the Standard Care Arrangement in advance.

WHERE IS THE FORMULARY? HOW OFTEN IS IT UPDATED?

The Formulary is maintained on the Board of Nursing website in the Nursing Practice Section. The Committee for Prescriptive Governance (CPG) meets two to three times throughout the year to discuss the drugs on the Formulary. Information regarding meeting dates may be accessed through the Board’s website. The Formulary is updated after the CPG meets. Each CTP holder is responsible for prescribing in accordance with the most current version of the Formulary.