Transcript 2015 Family Practice Review and ReunionFebruary 21

APRN PRACTICE UPDATE LAW
AND RULE 2014
 Discuss law and rules pertinent to contemporary APRN
practice in Ohio including the 2014 update
 Review the most recent changes in the Ohio Formulary.
 Briefly review Schedule II Prescribing and OARRS Law and
Rule
 State the requirements for staying compliant with Ohio’s
rules for APRN practice and briefly review what the APRN
should do if the “board comes knocking?”
 Predict the Legislative and Practice Future for Ohio APRNs
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» Law and Rules – Where are they?
» Title – What is title protection?
» Certificate of Authority
˃COA Components
» Scope of Practice
˃What is it?
˃APN Decision Tree –New practice
and procedures
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Review Topics - continued
• Standard Care Arrangement
Collaboration
Who signs?
Components of the SCA
Prescribing Parameters Update
Quality Assurance
Chart Review: when and who
Prescriptive Review: when and who
Relicensure – What do I need
Primary Source Verification
Continuing Education
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» Prescribing Principles and Standards
˃ Staying Compliant - Review
+ Pharmacology Hours
+ Licensure Maintenance
+ Keeping the BON Informed
+ SCA Key Points – What’s new?
+ Prescriptive Authority – What’s new?
» Schedule II – Brief Review
» Legislative Updates and Future Initiatives
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Ohio Revised Code (ORC) 4723 (Law)
 Voted and passed by General Assembly
 Signed by the Governor
 The Nurse Practice Act (ORC 4723)
Ohio Administrative Code (OAC) (Rules)
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Written by the regulatory boards (BON)
Cannot conflict with or expand the law
Rules assist to implement the law
Nursing Rules 4723-1 through 4723-23 (OAC)
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APRN State Rules
 http://codes.ohio.gov/oac/4723
APRN State Law
 http://codes.ohio.gov/orc/4723
APRN Federal Law
United States Code of regulations
Center for Medicare and Medicaid Services (CMS)
Board of Nursing (BON)
 http://www.nursing.ohio.gov/Practice.htm#AdvancedPractice
Board of Medicine – No direct APRN Authority
 www.med.ohio.gov
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» Provides legal recognition for practice
Unless individuals meet the requirements cannot
use the title ORC 4723-8-03
» Ties reimbursement to the title: RNs cannot
bill for physician services, APRNs bill for physician
services.
» Title Change occurred with H.B. 303, 2012:
+A.P.N initials changed to A.P.R.N. in all
Ohio statutes
+May still use CRNA, CNM, CNS, CNP
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Certificate of Authority
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COA required for APRN to practice:
Renews every 2 years with RN license;
Must have up to date national certification;
primary source verification within 30 days of
recertifying, (OAC 4723-8-08)
Current national certification:
If your national certification lapses by one day,
your COA is not active, no grace period, you must
cease practice (continuous certification required)
At Renewal: submit name and business addresses of
collaborating physicians (4723-8-08)
May place COA on inactive status (Ref. 4723-8-08 OAC)
What is your scope of practice?
Scope: defined by national certifying organizations, standards
of care, parameters of practice
NO LAUNDRY LIST IN OHIO OF PERMISSABLE SERVICES
HB 303 - 2013
Scope: as defined by ORC 4723.43: CRNPs provide
“preventative and primary care services …. OAAPN met with
BON and requested they include a CNP scope that was at
least consistent with CNS scope that recognizes complexity
and illness, not only primary or preventive care.
The BON added “provide services for acute illnesses, and
evaluate and promote patient wellness within the nurse’s
nursing specialty, consistent with the nurse’s education and
certification….”
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How to determine if a procedure is within
my scope?
“Decision-Making Guide for Determining Individual APN Scope
of Practice”.. Follow this guideline and ask the BON
www.nursing/ohio.gov/PDFS/AdvPractice/APNModelandIntro072406.pdf
Are APRNs supervised in Ohio?
Rarely: APRN CtP – Externship
CRNAs have supervisory language
Must a Doctor be on site or sign charts? NO
Exception: CtP-E for supervised hours)
Must be accessible by telecommunication
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SCA (4723-8-04) Must have one before you
practice
 Articulates the APRN & physician collaborating
relationship
 Must be signed by all collaborators unless it is
signed by the “physician’s designated
representative” – department director or
chair
 Signed and reviewed once a year (kept on site
– don’t send to BON)
 Must include the PI/PC Arrangement (OAC
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4723-9-10) NEW – NEW - NEW
SCA (4723-8-04) Must have one before you practice: keep on site
Includes:
broad statement of services;
description of prescriptive practice;
medications designated per SCA;
off label use of medications;
incorporation of new procedures;
referrals;
emergency coverage;
plans for infant care;
dispute settlement;
quality assurance process (4723-8-05); - physician must be involved
document physician licensure yearly
provisions for in-person physician evaluation if needed.
Samples available from OAAPN
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Collaborating Physician - Notify the Board
 H. B. 303 requires APRN to submit to the BON the
name and business address of each of the
collaborating physicians/podiatrist no later than 30
days after APRN first engages in practice as an APRN.
 Must notify BON of any changes in SCA signatories
within 30 days after any change takes effect
 see BON site for forms.
 Schedule II authority
 UPDATE SCA FOR PI/PC CATEGORY and PER SCA
CATEGORY
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Is a process for improvement that includes:
 QA Committee Members: Must include physician – may use
committee, physician component need not take part in all QA
activity
 Chart Review: regular (once a year minimum and document
outcomes and improvement)
 Prescriptive review (twice a year minimum and document)
inclusive of a representative sampling of schedule II if
prescribing schedule II
Additional information on the SCA may be found at the
OAAPN website: oaapn.org where an one hour CE on the
2014 SCA is available.
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Standard Care Arrangement –
Clarification of PI/PC
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SCA - Formulary Rule Changes
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LEGEND and Format Changes: all formulary drugs
are now categorized as: “may prescribe,” “physician
initiated,” “physician consult” or “may not
prescribe.” SCA may also include any additional parameters
pertaining to the prescribing of drugs indicated in this
column. Effective: APRIL 1, 2014
In Accordance with SCA: Means that drugs/drug categories
on the formulary under this column, must have the
prescribing designations determined jointly by the APRN and
CP and specified.
See current formulary (9/22/2014).
Formulary Legend Changes:
SCA Update – “In Accordance with SCA”:
*Use general category approval statement to cover all drugs
in this column
Example of general statement: “The APRN may
prescribe all formulary drugs under “in accordance with SCA
category”, per the APRN’s and collaborator’s scopes of
practice and within acceptable prescribing practices.”
*or address each drug individually in SCA Update – “In
Accordance with SCA”:
*Use individual drug approval statement, PI, PC or may not
prescribe
Formulary Legend
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*Off-Label Use: : *May prescribe if supported by
current peer review literature (which is accessible
by the CTP holder),and noted as the standard of
care in the SCA
*Compounded Drugs:
*Combination Drugs: Each component must be
“CTP holder may prescribe”
Limited conditions: Components must be FDA
approved and listed in formulary as may prescribe.
SCA must contain verbiage recognizing the
approved compounded drugs; if off label, follow
rules
Formulary Rule Changes:
» CE LAW and Rule 4723-14-03 – OAC: 1 hour
Category A, law and rule, must be approved by the
Ohio BON or offered by OBN approved provider
(every 2 years)
» HB 303, (2012)
Ohio APRN may use the CE used for national
certification to apply toward CE requirements for
renewal of APRN license as RN does if the CE is
obtained through a Program approved by the OHIO
BON or by a BON approved CE Provider.
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Re-licensure & COA
• Continuing Education Requirements:
(OAC 4723-14-05)
Licensure Renewal: (every 2 years)
*24 hrs. for RN renewal (1 hr. nursing law
and rule, Category A)
*12 hrs. in Pharmacology
Save documentation of all CEs for 6 years
*Must have some component addressing
controlled substances.
TOTAL: 36 hours for COA + CTP Renewal
Specialty certification every 5 years
See certifying organization for specifics
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 Prescriptive Authority
 Must have CtP (CtP – E can prescribe when licensed and if meets
supervision requirements).
 SCA must include prescribing authority of APRN to include off
label, Schedule II and per SCA arrangement (OAC 4723-9-10)
 Within Scope of Practice – congruent with specialty area of
physician and APRN
 May not prescribe any drug/device that induces an abortion
 Follow Federal and State Laws
 Sample Drugs
 Samples within the formulary
 Provided free of charge, may not repackage
 No more than 72 hour supply or smallest packaged amount
 No samples of DEA controlled substances
 (4723-9-09: 4723-9-08 OAC: 4723.50 ORC)
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 Prescriptive Authority
 Stock Medications
 Dispense or furnish stock medications by site: health
department, federally funded primary care clinic, or non
profit health care clinic, ( college: student health clinic),
maintain safety standards
 Dispensing stock medications by category: antifungals,
antibiotics, contraceptives, prenatal vitamins,
scabicides; asthma, antihypertensives, DM meds;
antilipidemics
4723-9-08 OAC: 4723.481 ORC
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 Furnishing Standards: ( must be on formulary – no controlled)
 Provide directions for Stock Medication use:
 Affix label & include: name of APN, name of patient, name and
strength of drug: directions for use; date furnished
 Must maintain record of all stock drugs and devices personally
furnished by the APN
 Prescribing Standards:
 Valid prescriber-patient relationship
+ Assessment/exam, diagnosis, document
+ Current certificate to prescribe, accordance with scope of
practice;
+ No friends or family member (additional rules & no
controlled meds); Use DEA if prescribing controlled meds,
+ According to APRN SCA & most current BON Formulary
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 Issuance of a Prescription: (4729-5-30)
 Must Have: Date, APRN name, address, title, telephone, same
identifiers for patient; drug, quantity, strength, directions for use;
refills; CtP on every prescription: no refills for schedule II
 May provide multiple prescriptions for schedule ll
 DEA for scheduled drugs
 Fax: not appropriate for schedule II: exception is LTC and Hospice
 Follow Hospice Patient prescription format (OAC 4729-5-15)
 All controlled drugs quantity written numerically and alphabetically
(4729-5-13)
 Formulary Use:
 Confirm Per SCA preference in SCA
 FDA and Off-Label Use: in accordance with formulary and
consistent with SCA
 Follow formulary review requirements
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Board of Medicine: OAC 4731-11-09
Prescribing to persons not seen by the physician/APRN
**Not approved, except in institutional settings, on call
situations, cross coverage situations, situations involving
new patients, protocol situations, situations involving
nurses practicing in accordance with standard care
arrangements, and hospice settings, as described in
paragraphs (D) and (E) of this rule,
**A physician shall not prescribe, dispense, or otherwise
provide, or cause to be provided, any controlled substance to a
person who the physician has never personally physically
examined and diagnosed.
• NOTE: This applies to APRNs.
 Approved Delegation of Med Administration/Unlicensed
(4723-13-05 OAC, 4723.07 ORC)
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OTC topical medications
OTC eye drops, ear drops
Suppository medications,
Foot soak treatments
Enemas
 CtP Externship Requirements for Out of State APRNs
 APNs who prescribed in another state within the last 3 years
 Included or excluded controlled substances
 Must complete 2 hour law and rule course specific to prescribing in29
Ohio (Follow rules 4723-9-08 – 4723-9-10)
Achieved limited Schedule II Prescriptive Authority – June
2012
Changes to SCA and Quality Assurance Requirements
 General Pharm CE requirements – 12 pharm hours with
some component for controlled substances
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In course objectives
IN COURSE TITLE
No specific # of CE required for controlled substances
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Quality assurance requiring representative sampling of
schedule II drugs if prescribed
 Must adhere to standards & rules OARRS
 Must be vigilant as new legislation introduced frequently
 3 initiatives passed in 2014
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Prescribing Schedule II
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» Schedule II prescribing outside of approved
site list:
1) Only in terminal condition with degree of
medical certainty it is terminal, there can be
no recovery
2) CP initially prescribed the substance for
the patient
3) The amount does not exceed a 24 hour
supply (ORC 4723.481)
These current rules on Schedule II do not apply if the
Schedule II drug is written from any of the listed
locations
NO CONVENIENCE CARE CLINICS EVER
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Approved Sites:
 Hospitals and any entity owned or controlled in whole or part by
hospital ORC 3701.07
 County Home Chapter 5155 ORC etc.
 Health care facility operated by department of mental health or
developmental disabilities
 Nursing Home: ORC 3721.02, or 3721.09 ORC
 Hospice care program ( home, outpatient, inpatient etc.)(3712.01 ORC)
 Community Mental Health Facility (ORC 5122.01)
 Ambulatory Surgical Facility 3702.30 ORC
 Free Standing Birthing Center (ORC 3702.51)
 FQHC or FQHC look a like (defined in section 1905 (1) (2) (B) of SSA 2264,
(1989(. 42 U.S.C. 1396d (1)(2)(B)). 3701.047 ORC
 Health Care Office/facility operated by ODH or board of health of
city/general district 3709.05 ORC
 Physician owned offices/practices
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 Excludes Convenience Care Clinics
Hospice Program or Hospice
Facility?
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Schedule II Rule Changes
 Amphetamines:
CTP Holder may prescribe with formal
established diagnosis
Per SCA if no formal diagnosis
Opioid Analgesics – Schedule II (NEW)
14 day maximum for initial therapy without
PI/PC
SCA must indicate amount > 14 day
supply per institutional protocol or per
PI/PC within SCA “In accordance with
SCA”
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Schedule II Prescribing Additional Requirements
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SCA Must Include:
*The exact authority to prescribe schedule 2
Example: May prescribe all scheduled
drugs per BON formulary: OR May prescribe all
schedule II with exception of stimulants: OR May
not prescribe schedule II drugs
*Quality assurance standards must be
inclusive of schedule II drugs, representative
sampling review
*APRN must follow all of the standards and
procedures for the utilization and review of
OARRS reports (OAC 4723-9-12)
Schedule II Prescribing Additional Requirements
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*Must have DEA with approval to
prescribe 2 and 2N noted on the license to
prescribe schedule II
*May not prescribe an opioid for the
treatment of drug addiction (Federal Law).
Problem for neonates with
abstinence syndrome
APRNS may not prescribe opioids for drug addiction to include neonates
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Recap: Prescribing Safely
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Prescribing Rules:
According to SCA
Scope of practice
Formulary requirements
Does not exceed your collaborator
Valid-patient prescriber relationship
No controlled substances – ever for family
DEA must have to prescribe II – V drugs
No device or substance that induces an abortion
Write CtP on all prescriptions
Follow OARRS regulations
DO NOT furnish a schedule II to anyone
DO NOT prescribe anabolic steroids (C-III)
(4723-9-09 OAC)
OARRS – What YOU Need to Know
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LAW AND RULES PERTINENT TO OHIO
CONTEMPORARY APRN PRACTICE - NEW
LAW AND RULES PERTINENT TO OHIO
CONTEMPORARY APRN PRACTICE - NEW
» ORC 4761.11 • APRNS may now supervise certified
hyperbaric technologists – Effective 9/4/2014.
» ORC 4723.486 •ALL PRESCRIBERS of Opioids and
Benzodiazepines must check OAARS before
prescribing - Effective 9/16/2014
» ORC 3712.062 •Requires a licensed hospice care
program that provides hospice care and services in a
patient's home to establish a written policy & adopt
certain practices for preventing the diversion of
controlled substances containing opioids –
˃ Effective 9/17/2014
» ORC 4723-48 • Mandatory Consent for Minors who
are prescribed Opioids – Effective 9/17/2014
˃ Go to StartTalking.ohio.gov for sample consent and tips
» ORC 1751.69 • Prohibits health insurance provided by
certain insurers from providing less favorable coverage
for orally administered cancer medication than for
intravenously administered or injected cancer
medications – Effective 9-17-2014
» ORC 4730.093 Lyme Disease: a written notice must be
given to patients when ordering a test for Lyme
disease. Notice is signed by the patient/POA and kept
in MR.
˃ Form required to make patients aware of difficulty in diagnosing Lyme disease,
as symptoms are often non-specific and found in other conditions
˃ Effective 9-17-2014
˃ Strategy to repeal started
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» ORC 4723.488 Naloxone Prescription to a Non-Patient
» Effective March 11, 2014,
» APRNs w/ CTP, to personally furnish/ issue naloxone
prescription to friend, family member, or other individual in
a position to provide assistance to an individual at risk of
experiencing an opioid-related overdose;
» Grants immunity from criminal or civil liability or
professional disciplinary action when acting in good faith;
» Requires health care professional to instruct individual to
whom the drug is furnished/prescription is issued to
summon EMS immediately before or immediately after
administering naloxone.
» HB 483 Budget Bill had nurse law changes to
include:
˃ Permits CNPs and CNSs to be added to a list of
professionals who may supervise various Chemical
Dependency Counselor professionals when treating
gambling disorders and various substance abuse
disorders.
˃ Permits a prescriber to request OARRS information
for mother of a newborn or infant patient, for the
purpose of providing medical treatment to the
newborn or infant after being diagnosed as opioid
dependent.
Current Legislative Initiatives
» HB 301 Introduced 10/16/13 ; passed committee,
now in House
» To authorize a person not otherwise authorized to
do so to administer certain drugs pursuant to
delegation by APRN who a CTP.
» Requires BON to establish standards and
procedures for the delegation of authority to
administer drugs
» Currently there is no opposition to this bill.
» PA association request that we agree to put 301
into 412 and help them get the bill passed in the
lame duck session.
» Hydrocodone Combination Products (VICODIN,
NORCO)moved from Schedule III to Schedule II
˃ Effective October 6, 2014
» Tramadol and products containing tramadol
moved to Schedule IV controlled substances in
Ohio pursuant to a rule adopted by the United
States DEA.
˃ Effective August 18, 2014
BARRIERS TO PRACTICE – FUTURE
PERSPECTIVES
Disciplinary actions on the rise in Ohio.
Preventive Action – Most Important
 Follow the rules of practice for Ohio APRNs
 Have all documents available for review at
your work site and up to date
Consult legal counsel – immediately
Do not call BON before you call your attorney
 Don’t represent yourself
 Know your rights
 Don’t sign anything
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Douglas Caserta, MSN, FNP-BC, APRN
Treasurer OAAPN
Member, Full Practice Authority Committee
[email protected]
937-670-2745
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