1. health and fitness
2. drugs

STATE MEDICAL
BOARD OF
OHIO
Facts about the
Medical Board
August 25, 2010
30 East Broad St. 3rd Floor
Columbus, OH 43215-6127
614-466-3934
MED.OHIO.GOV
Contents:
About the Medical Board
Board Member roster—2010
Medical Board Mission & Goals
Medical Board Strategic Plan
Licensees regulated by the Medical Board
Medical Board Complaint Outcomes
Steps to Medical Board Discipline
Disciplinary Actions taken 2005-2009
Disciplinary sanction definitions
OARRS fact sheets
Controlled Substance Rules — Chapter 4731-11, Ohio Administrative Code
Pain Management Rules — Chapter 4731-21, Ohio Administrative Code
Medical Board Contacts:
State Medical Board of Ohio
30 E. Broad St. 3rd Floor
Columbus, OH 43215-6127
med.ohio.gov
Richard A. Whitehouse, Esq.
Executive Director
[email protected]
(614) 644-4449
Joan K. Wehrle, CPMSM
Education & Outreach Program Manager
[email protected]
(614) 728-3684
The State Medical Board of Ohio
A National Leader in Public Protection
EFFECTIVE REGULATION: In April 2010, Ohio ranked first among the states responsible for regulating
20,000 or more physicians according to a report published by Public Citizen Health Research Group, a
national consumer advocacy organization. Public Citizen rated medical licensing boards in terms of
“serious” disciplinary actions imposed—defined as license revocations, suspensions, surrenders, and
probations or restrictions based upon the disciplinary actions taken in 2007 – 2009. The Ohio Medical
Board has ranked in Public Citizen’s top 10 each year since 1995.
In March 2010, the Federation of State Medical Boards of the United States listed Ohio fifth in terms of
disciplinary sanctions imposed during calendar year 2009 by medical licensing boards with a minimum
of 15,000 in-state (physician) licensees. The State Medical Board of Ohio regulates approximately
61,000 licensees of all types, 41,000 of which are physicians—one of the largest licensee pools in the
country—and receives approximately 4,000 complaints and takes approximately 190 disciplinary actions
against licensees each year.
ROLE OF THE MEDICAL BOARD: Established by the state legislature in 1896, the Medical Board strives
to protect and enhance the health and welfare of Ohio’s citizens through effective regulation of more
than 61,000 licensees, including: medical doctors (MDs), doctors of osteopathic medicine (DOs),
doctors of podiatric medicine and surgery (DPMs), physician assistants (PAs), massage therapists (MTs),
cosmetic therapists (CTs), anesthesiologist assistants (AAs), radiologist assistants (RAs) and
acupuncturists. The Medical Board also oversees naprapaths and mechanotherapists licensed before
March 1992.
COMPOSITION OF THE BOARD: The Medical Board is comprised of twelve members: nine physicians
and three non-physician public members. All of the Board members are appointed by the Governor and
serve five-year terms. Board members may be reappointed. Appointees' terms are staggered to provide
continuity. Two members serve as the Board's Secretary and Supervising Member who are responsible
for overseeing the Board's investigatory and enforcement processes. The Secretary is a physician
member and a consumer member has served as Supervising Member since July 1993.
AGENCY OPERATIONS AND FUNDING: The agency supports 87 full time positions. The Executive
Director, who is an attorney, oversees day-to-day operations. The Medical Board receives no monies
from the state's general revenue fund. Licensure application and renewal fees are the primary source
of funding for Board operations.
PRACTICE REMEDIATION EFFORTS: Adopted into law in 1996, the Quality Intervention Program (QIP)
is part of the Medical Board’s confidential investigatory processes and is designed to address quality of
care complaints that do not appear to warrant intervention via formal disciplinary action. QIP focuses
on cases in which poor practice patterns are beginning to emerge or the licensee has failed to keep up
with changes in practice standards. With a successful intervention, the licensee benefits by improving
practice methods; patients benefit from having a better practitioner available to address their
healthcare needs; and the Medical Board protects the public without an adverse impact on the
availability of care in the community.
A key component of the program is the use of two Quality Intervention Panels, each comprised of six
physicians and one consumer member who are responsible for assessing the practice of the licensee
referred to the program and making recommendations to the Board’s Secretary and Supervising
Member based upon their assessment. Between January 2000 and December 2009, the Board’s Quality
Intervention panels reviewed 1,040 cases and directed 186 licensees into focused re-education to
address deficiencies identified through expert panel review. Courses related to improving medical
record keeping practices and prescribing controlled substances were the most frequent referrals
suggested by the QIP panels. Section 4731.22(O), Ohio Revised Code, requires licensees participating in
an individual education program recommended by the QIP to pay any costs related to that educational
program.
State Medical Board of Ohio
30 E. Broad St. 3rd Floor
Columbus, OH 43215
med.ohio.gov
State Medical Board of Ohio
30 E. Broad Street, 3rd Floor, Columbus, OH 43215-6127
Richard A. Whitehouse, Esq.
Executive Director
(614) 466-3934
med.ohio.gov
2010 MEDICAL BOARD ROSTER Each Board Member is appointed by the Governor to a five‐year term on the Board. The Governor may reappoint a Board member to additional terms on the Board. Jack C. Amato, M.D. President Gynecology 41866 Old Irondale Road Irondale, OH 43932 Term: 03/19/07 – 03/18/12 Marchelle L. Suppan, D.P.M. Vice President Podiatry 2785 Wayne St. Orrville, OH 44667 Term: 3/05/08 – 12/27/12 Lance A. Talmage, M.D. Secretary OB/GYN 45 Exmoor Ottawa Hills, OH 43615‐2174 Term: 03/19/09 ‐ 03/18/14 Raymond J. Albert Supervising Member Public Member 7505 Bunker Hill Rd. Amanda, OH 43102 Term: 08/01/07 ‐ 07/31/12 Whitney Frank Hairston, Jr. Public Member 3887 Lovers Lane Ravenna, OH 44266 Term: 12/5/07 – 7/31/12 Dalsukh Madia, M.D. Anesthesiology 1040 Delaware Ave. Marion, OH 43302 Term: 03/19/06 – 03/18/11 Darshan Mahajan, M.D. Neurology 673 E. River St. Elyria, OH 44035 Term: 05/13/08 – 03/18/13 Brian Morris Public Member 2473 Bexford Place Columbus, OH 43209 Term: ending 07/31/13 Kris Ramprasad, MD Gastroenterology 7760 Hartford Hill Lane Cincinnati, OH 45242 Term: 04/23/2010 – 03/18/2015 Anita M. Steinbergh, D.O. Family Practice 550 S. Cleveland Ave. Suite C Westerville, OH 43081 Term: 04/26/08 ‐ 04/25/13 Susan E. Stephens, M.D Orthopedic Surgery of the Spine 5 Severance Circle #609 Cleveland Hts., OH 44118 Term: 03/19/08 – 03/18/13 J. Craig Strafford, MD, FACOG OB/GYN 494 Buhl Morton Rd. Gallipolis, OH 45631‐8524 Term: 11/17/09 ‐ ‐3/18/14 EXECUTIVE DIRECTOR Richard A. Whitehouse, Esq. State Medical Board of Ohio rd
30 E. Broad St. 3 Floor Columbus, OH 43215‐6127 To protect and enhance the health and safety of the public through effective medical regulation
State Medical Board of Ohio
HOW WE CARRY OUT OUR MISSION AND GOALS
AGENCY MISSION: To protect and enhance the health and safety of the public through effective
medical regulation.
AGENCY GOALS:
Ensure that persons practicing medicine meet sufficient standards of education, training, competence and
ethics
•
•
•
•
•
•
administer licensure examinations
review applications and credentials for licensure or registration
review and approve limited branch training programs
update licensee information at the time of renewal
verify license status
audit compliance of licensees with mandatory continuing education requirements
Define and advocate for standards of safe medical practice
•
•
•
•
promulgate rules
monitor state and federal legislation related to medical practice issues
adopt position statements
publish advisory information or standards
Rehabilitate, when possible, persons who are impaired or who practice medicine unethically or below
minimal standards of care, and prohibit person who have not been rehabilitated from practicing medicine
•
•
•
•
monitor probationary compliance with Medical Board orders and agreements
approve drug and alcohol treatment programs
refer licensees with remediable practice deficiencies to the Quality Intervention Program
interact with impaired professionals programs
Prohibit persons from practicing medicine whose violations are so egregious as to forfeit the privilege or
who otherwise lack the legal authority
•
•
•
investigate complaints
take formal disciplinary actions
initiate criminal charges or injunctions
Provide information about the licensees of the Medical Board, the Board’s functions and operations, and
the laws governing the practice of medicine
•
•
•
•
•
•
update and expand the content and services provided through the agency’s internet website
publish a newsletter
provide notice of Medical Board disciplinary actions
circulate consumer guides and other publications
respond to inquiries from consumers, licensees, the media, and other interested parties
deliver presentations to interested groups
Achieve and maintain the highest possible levels of organizational efficacy
•
•
•
•
implement technology to enable the agency to upgrade and consolidate operational processes and to
expand the on-line services available to licensees and the public
evaluate all facets of agency performance on a recurring basis
develop or modify procedures needed to improve organizational efficacy
assure the sufficiency of agency resources on a continuing basis
STATE MEDICAL BOARD
of Ohio
SMB Strategic Plan for 2011
QUALITY OF HEALTH CARE REGULATION
STRATEGY ONE:
Culture – Create an Ethics Driven/High Performance Workplace.
We must reshape our workforce and address underinvestment in our organizational capacity  specifically, staffing,
training, and technology. We will exhibit greater professionalism and adopt a “customer service” approach to dealing
with stakeholders and each other. Finally, we must periodically reevaluate systems and processes to challenge longtime
assumptions that permit “satisfactory underperformance” focusing specifically on the interval between receipt and
disposition of complaints. To do so, we will develop metrics, performance measures, and goals that promote
accountability, increase efficiency, and establish our board as a model for others.
STRATEGY TWO:
Competency – Develop a Holistic Approach to “Effective Medical Regulation” that Helps Maintain the
Competency of Licensees & Prevents Adverse Outcomes.
We will be pro-active in dealing with at-risk licensees in order to protect the public and preserve our stakeholder’s
interests in maintaining or restoring a licensee’s ability to practice. Such efforts include revamping current quality
intervention efforts, developing tools to deal more effectively with minimal standards cases, and analyzing the need for
specific areas of remediation. We will ensure that consent agreements between the Board and licensees are clear,
consistent, and creative; and that efforts to rehabilitate or remediate are effective as evidenced by performance
measures. We will provide stakeholders with information that clearly reflects Board expectations regarding policies and
rules involving professional conduct, minimal standards, best practices, and scope of practice.
STRATEGY THREE:
Collaboration – Engage in Partnerships with Stakeholders and Others in Order to Leverage Available
Resources and Improve Healthcare in Ohio.
We can protect the public by “building a better licensee” through public and private sector partnerships with the
legislature, professional schools, associations, media, state agencies, and other stakeholders. Our efforts will be
designed to instill a unique sense of ethics and professionalism in licensees that puts them on notice regarding the
Board’s expectations as a regulatory body. We can also develop, analyze, and share data documenting trends impacting
the cost, quality, or availability of healthcare in Ohio with stakeholders through a communications plan designed to
promote the Board’s mission of protecting the public.
Adopted December 15, 2005
132
129
Acupuncturist - A
Anesthesiologist Assistant - AA
24
24
0
254
688
14
PA with provisional prescriptive authority
PA with prescriptive authority
Visiting Medical Faculty certificates
0
14
6
14
702
260
61,828
112
153
156
79
942
4,108
6
1,994
1
31
960
36,802
4,908
11,380
30
166
Total active licensees
June 30, 2010
* Restricted Cosmetic Therapist - those licensed as electrologists by the Ohio Board of Cosmetology prior to Feb. 1, 1993 (Rule 4731-1-07, OAC)
11,929
79
DPM Training Certificate
0
49,899
942
DO Training Certificate
0
112
4,108
MD Training Certificate
0
132
0
1
127
9,391
1,231
881
0
6
Active Licenses
Out of State address
0
6
Radiologist Assistant - RA
Telemedicine Licenses
1,862
1
Naprapath - NAP
Physician Assistant - PA
30
Mechanotherapist - DM
27,411
Medical Doctor - MD
833
3,677
Doctor Of Osteopathy - DO
Doctor Of Podiatric Medicine - DPM
10,499
30
Restricted Cosmetic Therapist - RCT *
Massage Therapist - MT
160
Active Licenses
Ohio address
Cosmetic Therapist - CT
License-Type
State Medical Board of Ohio
Active Licensee Count as of June 30, 2010
• About 90% closed –
no action taken by
Board
• About 10% serve as
basis for disciplinary
actions
Over 4000 complaints
received a year
Complaint closed
Complaint
closed
no investigation
norequired
investigation
required
Complaint
closedafter
after investigation;
investigation;
Complaint
closed
disciplinary action taken
nono
disciplinary
action taken
Action
Action
taken
taken
Medical Board Complaint Outcomes
Key Steps to Ohio Medical Board Discipline
Complaint received by Medical Board
(confidential)
Complaint review
finds issue is not
within Board’s
jurisdiction
Complaint allegations investigated
(confidential)
Complaint closed
(confidential)
Facts learned through investigation
support disciplinary action by Medical Board
Enforcement staff develops case
for disciplinary action
(confidential)
Medical Board approves issuance
of a citation
(public information)
Hearing requested by
licensee; Hearing held
(public information)
(public information)
Board legal staff prepares
Findings, Order & Journal
Entry for
Medical Board review
Hearing Examiner
prepares Report &
Recommendation for
Medical Board review
(public information)
(public information)
(public information)
(confidential)
Complaint closed
(confidential)
Consent Agreement or Settlement
Agreement ratified by Medical Board
(public information)
No Hearing requested
by licensee
Medical Board issues Order
Complaint does not
support disciplinary
action
STATE MEDICAL BOARD OF OHIO
SUMMARY OF DISCIPLINARY ACTIONS 2005 - 2009
2005
2006
2007
2008
2009
TOTAL DISCIPLINARY ACTIONS
178
183
175
187
211
Revocations
31
41
35
36
38
Indefinite Suspensions
56
44
46
51
56
Definite Suspensions
10
4
5
3
7
Probations
37
42
47
46
56
Reprimands
4
11
12
9
3
Practice Limitations
4
5
1
5
2
Surrenders/Retirements
7
11
7
4
7
Licensure denials or application
withdrawals for disciplinary reasons
12
14
13
21
16
Summary Suspensions
12
5
3
8
6
Automatic Suspensions
2
1
2
2
5
Immediate Suspensions
1
3
1
2
9
Interim Agreement
0
0
3
0
1
Application approved/ conditionally
approved
No Penalty Imposed
0
0
0
0
1
2
2
0
0
4
STATE MEDICAL BOARD OF OHIO PERMANENT REVOCATION REVOCATION SUSPENSION LIMITATION PROBATION PERMANENT DENIAL DENIAL REPRIMAND GLOSSARY OF DISCIPLINARY TERMS The permanent loss of a certificate to practice in Ohio and the inability, at any time, to reapply for or hold any certificate to practice in Ohio. An individual whose certificate has been permanently revoked shall forever thereafter be ineligible to hold any certificate to practice, and the board shall not accept from that individual an application for reinstatement or restoration of the certificate or for issuance of a new certificate. (Chapter 4731‐13‐36 (A), Ohio Administrative Code) The loss of a certificate to practice in Ohio. An individual whose certificate has been revoked shall be eligible to submit an application for a new certificate. All disciplinary action taken by the board against the revoked certificate shall be made a part of the board’s records for any new certificate granted under this rule. (Chapter 4731‐13‐36 (B), Ohio Administrative Code) The temporary loss of a certificate to practice in Ohio. A suspension shall be imposed for either a definite or an indefinite period of time. (Chapter 4731‐13‐
36 (C), Ohio Administrative Code) Precludes the certificate holder from engaging in a particular conduct or activity, to impose conditions on the manner in which that conduct or activity may be performed, or to require the certificate holder to abide by specific conditions in order to continue practicing medicine. A limitation shall be either temporary or permanent. (Chapter 4731‐13‐36 (D), Ohio Administrative Code) A situation whereby the certificate holder shall continue to practice only under conditions specified by the board. Failure of the certificate holder to comply with the conditions of probation may result in further disciplinary action being imposed by the board. The probation period shall be for either a definite or indefinite term. If probation is for an indefinite term, the board shall establish a minimum probation period and the board shall release the certificate holder from the conditions of probation upon completion of the minimum probation period and upon the board’s determination that the purpose of probation has been fulfilled. (Chapter 4731‐13‐36 (E) Ohio Administrative Code) The permanent denial of an application for a certificate to practice in Ohio. An individual whose application for a certificate has been permanently denied shall forever thereafter be ineligible to apply to the board for any certificate to practice, and the board shall not accept from that individual an application for issuance of a certificate. (Chapter 4731‐13‐36 (J), Ohio Administrative Code) The denial of an application for a certificate to practice in Ohio. An individual whose application for a certificate has been denied shall be eligible to submit a new application for a certificate. In determining whether to grant a new application, the board may consider any statutory violations that were committed by the individual before or after the denial of the individual’s previous application, including those that formed the basis for the denial. (Chapter 4731‐13‐36 (K), Ohio Administrative Code) The certificate holder is formally and publicly reprimanded in writing. (Chapter 4731‐13‐36 (F), Ohio Administrative Code) STATE MEDICAL BOARD OF OHIO CONSENT AGREEMENT VOLUNTARY SURRENDER DISMISSAL SUMMARY SUSPENSION AUTOMATIC SUSPENSION IMMEDIATE SUSPENSION APPLICATION CONDITIONALLY APPROVED INTERIM AGREEMENT CITATION LETTER: updated 9/09 ‐ jkw GLOSSARY OF DISCIPLINARY TERMS Conditions and limitations placed on licensee’s practice by mutual agreement with the Medical Board. A Step 1 Consent Agreement suspends the license and contains terms and conditions to be met before the licensee may request reinstatement/restoration of their license. A Step II Consent Agreement may reinstate a suspended license, which enables the licensee to return to practice. The Step II Consent Agreement includes probationary monitoring terms and conditions that must be met for a specified term of probation before the licensee may request release from probation. Practitioner surrenders license to practice in lieu of further disciplinary proceedings; may authorize the Board to revoke the practitioner’s license without further legal proceedings. The Board finds that no violation has occurred. (Chapter 4731‐13‐36 (H), Ohio Administrative Code) License to practice is suspended prior to a hearing based on clear and convincing evidence that continued practice by the licensee poses a danger of immediate and serious harm to the public. (Section 4731.22 (G), Ohio Revised Code) License to practice is suspended prior to a hearing when a licensee pleads guilty to, is found by a judge or jury to be guilty of, or is found eligible for intervention in lieu of conviction in this state or treatment or intervention in lieu of conviction in another jurisdiction for specified crimes of violence. (Section 4731.22 (I), Ohio Revised Code) License to practice is suspended prior to a hearing pursuant to Section 3719.121, Ohio Revised Code, when a licensee pleads guilty to, is found by a judge or jury to be guilty of, or is found eligible for treatment in lieu of conviction of a felony drug abuse offense. License approved subject to satisfaction of specific requirements(s) ordered by the Board, such as successful completion of an examination measuring current clinical abilities. Licensee agrees to cease practice or to practice with limitations until the administrative hearing process is completed and the Board issues a Final Order imposing a disciplinary sanction. In compliance with Ohio’s Administrative Procedures Act (Chapter 119, Ohio Revised Code), a citation letter is the formal notice sent to an individual informing them that the Medical Board intends to take disciplinary action based upon the reasons listed in the letter. The letter also advises that they may request a hearing on the matter but the hearing request must be received within 30 days of the date the notice was mailed by the Board. OHIO Automated Rx Reporting System
77 South High Street, Room 1702; Columbus, OH 43215-6126
-Equal Opportunity Employer and Service Provider-
TEL: 614/466-4143
E-MAIL: [email protected]
FAX: 614/644-8556
TTY/TDD: Use the Ohio Relay Service: 1-800/750-0750
URL: http://www.ohiopmp.gov
FACT SHEET for Health Professionals
Name: Ohio Automated Rx Reporting System, or OARRS
OARRS is a program that collects prescription data from pharmacies licensed by the
Ohio Board of Pharmacy (including mail order pharmacies). The data is housed in a highsecurity database.
Website: www.ohiopmp.gov
OARRS data is available in a patient-specific format to prescribers and pharmacists for use in
treating a patient. The prescriber or pharmacist must have a prescriber-patient or
pharmacist-patient relationship prior to requesting a report.
Drugs included:
All controlled substances, schedules II-V
Carisoprodol products (e.g. Soma®)
Tramadol products (e.g. Ultram®)
Patients:
Includes: all outpatients, residents in assisted living facilities, some inmates
Excludes: hospital inpatients, residents of nursing homes, some inmates
A prescriber or pharmacist requesting a report must have a prescriber-patient or pharmacistpatient relationship with the person on whom a report is requested. Obtaining data on any
other person is a violation of the statute.
A prescriber or pharmacist may NOT allow anyone else to use his or her User Name and
Password to obtain a Patient Rx History Report. Delegate accounts are available for licensed
office staff (e.g. RN, LPN, APN, PA,) to use on behalf of a prescriber.
Turnaround Time: The website is available 24/7. In most cases, the patient report is available
for viewing within 3 minutes.
Lag-time: It takes approximately 10-12 days from the date a prescription is dispensed until it
appears in an OARRS report.
Uses for the report: A report provides a patient’s history of prescription over time. It should
be used to supplement a patient evaluation, to confirm a patient’s drug history, or document
compliance with a therapeutic regimen.
OARRS does not warrant any report to be accurate or complete. The Report is based on the
search criteria entered and the data entered by the dispensing pharmacy. For more information
about any prescription in an OARRS report or to verify a prescription, contact the pharmacy
that dispensed it.
OARRS is an on-line service. A prescriber, pharmacist, or prescriber’s delegate must apply for
an account and be credentialed prior to receiving patient information. This may take 2 weeks.
For more information on the OARRS program, contact OARRS Staff
E-mail: [email protected]
Phone: 614-466-4143
PRESCRIBERS
OARRS WebCenter Application
Summary of Instructions
If you have any problems, please contact OARRS support by email at [email protected] or by phone
at 614-466-4143.
Before you start, make a copy of your
o Driver’s license,
o Medical license, and
o DEA registration certificate
Step 1 – Go to www.ohiopmp.gov. Click on the left box titled “Health Care
Professionals and Law Enforcement”. Then click on the box in the upper left titled “Click
here to Register”.
Step 2 – Enter your Driver’s License number
Step 3 – Select your Account type – Choose “Prescriber Master”
Step 4 – Read and Approve the Acceptable Use Policy – Note: you may not share your user
name and password with anyone else, including office staff.
Click “Approve” at the bottom of the page to continue.
Step 5 – Complete the application
A. Enter your personal and professional information
Provide the e-mail address that you want OARRS to use when communicating with you.
You may enter your own security question or choose one of ours.
B. Click “Submit” to proceed. After clicking Submit, you will receive an email with a 6- digit
verification code.
Step 6 – Edit or Retrieve your Application
A. Enter Verification Code: Enter the 6-digit verification code and click “Submit”.
B. Edit Application if necessary:
C. Print Application:
*To retrieve your application, repeat Steps 1 and 2
Step 7 – Sign, notarize, and mail.
A. Sign your application in the presence of a public notary.
B. Mail your notarized application and the photocopies of your driver’s license, medical
license, and DEA registration certificate to the address on the application.
If your application is approved, you will receive a user name by e-mail and
password by postal mail to your home. If you do not receive both within 10
business days of mailing your application, please email OARRS at
[email protected] or call 614-466-4143.
Controlled Substances
Chapter 4731-11, Ohio Administrative Code
4731-11-01 Definitions.
As used in Chapter 4731-11 of the Administrative
Code:
(A) A physician shall not utilize a controlled
substance other than in accordance with all of the
provisions of this chapter of the Administrative
Code.
(A) “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.
(B) Any other provisions of this chapter of the
Administrative Code notwithstanding, a physician
may utilize the schedule II controlled substance
cocaine hydrochloride only as a topical
anesthetic in situations in which it is properly
indicated.
(B) “Controlled substance stimulant” means any
drug, compound, mixture, preparation, or
substance which is classified as a stimulant in
controlled substance schedule II, III, or IV listed
in section 3719.41 of the Revised Code, or which
is classified as a stimulant in controlled
substances schedule II, III, or IV pursuant to
section 3719.43 or 3719.44 of the Revised Code.
(C) A physician shall not utilize a controlled
substance without taking into account the drug’s
potential for abuse, the possibility the drug may
lead to dependence, the possibility the patient will
obtain the drug for a nontherapeutic use or to
distribute to others, and the possibility of an illicit
market for the drug.
(C) “Utilize a controlled substance or controlled
substance stimulant” means to prescribe,
administer, dispense, supply, sell or give a
controlled substance or controlled substance
stimulant.
(D) “Recognized contraindication” means any
contraindication to the use of a drug which is
listed in the United States food and drug
administration (hereinafter, “F.D.A.”) approved
labeling for the drug, or which the board
determines to be accepted as a contraindication.
(E) “The board” means the state medical board of
Ohio.
(F) “BMI” means body mass index, calculated as
a person’s weight in kilograms divided by height
in meters squared.
(G) “Physician” means an individual holding a
certificate under Chapter 4731. of the Revised
Code to practice medicine and surgery,
osteopathic medicine and surgery, or podiatric
medicine and surgery and practicing within his or
her scope of practice as defined by section
4731.51 of the Revised Code.
Review dates: 06/06/2008 and 06/06/2013
Prior Effective Dates: 11/17/86; 10/31/98; 9/1/00
4731-11-02 General provisions.
(D) A physician shall complete and maintain
accurate medical records reflecting the
physician’s examination, evaluation, and
treatment of all the physician’s patients. Patient
medical records shall accurately reflect the
utilization of any controlled substances in the
treatment of a patient and shall indicate the
diagnosis and purpose for which the controlled
substance is utilized, and any additional
information upon which the diagnosis is based.
(E) A physician shall obey all applicable
provisions of sections 3719.06, 3719.07, 3719.08
and 3719.13 of the Revised Code, and all
applicable provisions of federal law governing the
possession, distribution, or use of controlled
substances.
(F) A violation of any provision of this rule, as
determined by the board, shall constitute “failure
to maintain minimal standards applicable to the
selection or administration of drugs,” as that
clause is used in division (B)(2) of section
4731.22 of the Revised Code; and “a departure
from, or the failure to conform to, minimal
standards of care of similar physicians under the
same or similar circumstances, whether or not
actual injury to a patient is established,” as that
clause is used in division (B)(6) of section
4731.22 of the Revised Code. A violation of
paragraph (B) of this rule shall further constitute
“selling, prescribing, giving away, or
administering drugs for other than legal and
legitimate therapeutic purposes,” as that clause is
used in division (B)(3) of section 4731.22 of the
Revised Code. A violation of paragraph (C) of
this rule, if committed purposely, knowingly, or
Controlled Substances
Chapter 4731-11, Ohio Administrative Code
recklessly, as those words are defined in section
2901.22 of the Revised Code, shall further
constitute “selling, giving away, personally
furnishing, prescribing, or administering drugs for
other than legal and legitimate therapeutic
purposes,” as that clause is used in division
(B)(3) of section 4731.22 of the Revised Code.
Effective: 09/30/2008
Review dates: 06/06/2008 and 09/30/2013
Prior Effective Dates: 11/17/86; 9/1/00
4731-11-03 Schedule II controlled substance
stimulants.
(A) A physician shall not utilize a schedule II
controlled substance stimulant for any purpose
except:
(1) The treatment of narcolepsy, idiopathic
hypersomnia, and hypersomnias due to
medical conditions known to cause excessive
sleepiness;
(2) The treatment of abnormal behavioral
syndrome (attention deficit disorder,
hyperkinetic syndrome), and/or related
disorders of childhood;
(3) The treatment of drug-induced or traumainduced brain dysfunction;
(4) The differential diagnostic psychiatric
evaluation of depression;
(5) The treatment of depression shown to be
refractory to other therapeutic modalities,
including pharmacologic approaches, such as
tricyclic antidepressants and MAO inhibitors;
(6) As adjunctive therapy in the treatment of
the following:
(a) Chronic severe pain;
(b) Closed head injuries;
(c) Cancer-related fatigue;
(d) Fatigue experienced during the
terminal stages of disease;
(e) Depression experienced during the
terminal stages of disease; or
(f) Intractable pain, as defined in rule
4731-21-01 of the Administrative Code.
(B) A physician shall not utilize a schedule II
controlled substance stimulant for purposes of
weight reduction or control.
(C) A physician may utilize a schedule II
controlled substance stimulant when properly
indicated for any purpose listed in paragraph (A)
of this rule, provided that all of the following
conditions are met:
(1) Before initiating treatment utilizing a
schedule II controlled substance stimulant,
the physician obtains a thorough history,
performs a thorough physical examination of
the patient, and rules out the existence of any
recognized contraindications to the use of the
controlled substance stimulant to be utilized.
(2) The physician shall not utilize any
schedule II controlled substance stimulant
when he knows or has reason to believe that
a recognized contra-indication to its use
exists.
(3) The physician shall not utilize any
schedule II controlled substance stimulant in
the treatment of a patient who he knows or
should know is pregnant.
(4) Upon ascertaining or having reason to
believe that the patient has a history of or
shows a propensity for alcohol or drug abuse,
or that the patient has consumed or disposed
of any controlled substance other than in strict
compliance with the treating physician’s
directions, the physician shall reappraise the
desirability of continued utilization of schedule
II controlled substance stimulants and shall
document in the patient record the factors
weighed in deciding to continue their use. The
physician shall actively monitor such a patient
for signs and symptoms of drug abuse and
drug dependency.
(D) A violation of any provision of this rule, as
determined by the board, shall constitute “failure
to maintain minimal standards applicable to the
selection or administration of drugs,” as that
clause is used in division (B)(2) of section
4731.22 of the Revised Code; “selling, giving
away, personally furnishing, prescribing, or
administering drugs for other than legal and
legitimate therapeutic purposes,” as that clause is
Controlled Substances
Chapter 4731-11, Ohio Administrative Code
used in division (B)(3) of section 4731.22 of the
Revised Code; and “a departure from, or the
failure to conform to, minimal standards of care of
similar practitioners under the same or similar
circumstances, whether or not actual injury to a
patient is established,” as that clause is used in
division (B)(6) of section 4731.22 of the Revised
Code.
Effective: 04/30/2009
Review dates: 06/06/2008 and 04/30/2014
Prior Effective Dates: 11/17/86; 10/31/98; 9/1/00
4731-11-04 Controlled substances: Utilization
for weight reduction.
(A) A physician shall not utilize a schedule III or
IV controlled substance for purposes of weight
reduction unless it has an F.D.A. approved
indication for this purpose and then only in
accordance with all of the provisions of this rule.
(B) Before initiating treatment for weight
reduction utilizing any schedule III or IV
controlled substance:
(1) The physician shall determine through
review of the physician’s own records of prior
treatment, or through review of the records of
prior treatment which another treating
physician or weight-loss program has
provided to the physician, that the patient has
made a substantial good-faith effort to lose
weight in a treatment program utilizing a
regimen of weight reduction based on caloric
restriction, nutritional counseling, behavior
modification, and exercise, without the
utilization of controlled substances, and that
said treatment has been ineffective.
(2) The physician shall obtain a thorough
history, perform a thorough physical
examination of the patient, determine that the
patient has a BMI of at least thirty, or at least
twenty-seven with comorbid factors, and rule
out the existence of any recognized
contraindications to the use of the controlled
substance to be utilized.
(3) The physician shall assess and document
the patient’s freedom from signs of drug or
alcohol abuse, and the presence or absence
of contraindications and adverse side effects.
(C) A physician may utilize a schedule III or IV
controlled substance, that bears appropriate
F.D.A. approved labeling for weight loss or the
maintenance of weight loss, in the treatment of
obesity only as an adjunct, in a regimen of weight
reduction based on caloric restriction, provided
that:
(1) The physician shall personally meet faceto-face with the patient, at a minimum, every
thirty days when controlled substances are
being utilized for weight reduction, and shall
record in the patient record information
demonstrating the patient’s continuing efforts
to lose weight, the patient’s dedication to the
treatment program and response to treatment,
and the presence or absence of
contraindications, adverse effects, and
indicators of possible substance abuse that
would necessitate cessation of treatment
utilizing controlled substances.
(2) The controlled substance is prescribed
strictly in accordance with the F.D.A.
approved labeling;
(a) If the F.D.A. approved labeling of the
controlled substance being utilized for
weight loss states that it is indicated for
use for “a few weeks”, the total course of
treatment using that controlled substance
shall not exceed twelve weeks. That time
period includes any interruption in
treatment that may be permitted under
paragraph (C)(3) of this rule; and
(b) If the F.D.A. approved labeling of the
controlled substance being utilized for
weight loss states that it is indicated for
use for maintenance of weight loss, that
use cannot exceed the time period
indicated as effective as reported in the
clinical studies’ information contained in
the F.D.A. approved labeling. That time
period includes any interruption in
treatment permitted under paragraph
(C)(3) of this rule.
(3) A physician shall not initiate a course of
treatment utilizing a controlled substance for
purposes of weight reduction if the patient has
received any controlled substance for
purposes of weight reduction within the past
six months. However, the physician may
resume utilizing a controlled substance
following an interruption of treatment of more
than seven days if the interruption resulted
from one or more of the following:
Controlled Substances
Chapter 4731-11, Ohio Administrative Code
(a) Illness of or injury to the patient
justifying a temporary cessation of
treatment; or
(b) Unavailability of the physician; or
(c) Unavailability of the patient, if the
patient has notified the physician of the
cause of the patient’s unavailability; or
(d) If the physician utilizes a controlled
substance that bears F.D.A. approved
labeling for “weight loss and the
maintenance of that weight loss” and
based on sound medical judgment
believes that an interruption of that
treatment was medically indicated so long
as its use is in accordance with paragraph
(C) of this rule.
(4) After initiating treatment, the physician
may elect to switch to a different controlled
substance for weight loss based on sound
medical judgment, but the total course of
treatment for any combination of controlled
substances each of which is indicated for “a
few weeks” shall not exceed twelve weeks.
(5) If the patient has continued to lose weight
under the short term treatment, the physician
may continue therapy utilizing a controlled
substance that bears F.D.A. approved
labeling for “weight loss and the maintenance
of that weight loss” so long as its use is in
accordance with paragraph (C) of this rule.
(6) The physician shall not initiate or shall
discontinue utilizing all controlled substances
for purposes of weight reduction immediately
upon ascertaining or having reason to believe:
(a) That the patient has a history of or
shows a propensity for alcohol or drug
abuse, or has made any false or
misleading statement to the physician
relating to the patient’s use of drugs or
alcohol; or
(b) That the patient has consumed or
disposed of any controlled substance
other than in strict compliance with the
treating physician’s directions.
(7) The physician shall not initiate or shall
discontinue utilizing all schedule III or IV
controlled substances that do not bear F.D.A.
Approved labeling which permits long-term
use immediately upon ascertaining or having
reason to believe:
(a) That the patient has failed to lose
weight while under treatment with a
controlled substance or controlled
substances over a period of thirty days
during the current course of treatment,
which determination shall be made by
weighing the patient at least every thirtieth
day, except that a patient who has never
before received treatment for obesity
utilizing any controlled substance who fails
to lose weight during the first thirty days of
the first such treatment attempt may be
treated for an additional thirty days; or
(b) That the patient has repeatedly failed
to comply with the physician’s treatment
recommendations.
(8) The physician shall not utilize any
schedule III or IV controlled substance for
purposes of weight reduction in the treatment
of a patient the physician knows or should
know is pregnant.
(D) A violation of any provision of this rule, as
determined by the board, shall constitute “failure
to maintain minimal standards applicable to the
selection or administration of drugs,” as that
clause is used in DIVISION (B)(2) of section
4731.22 of the Revised Code; “Selling, giving
away, personally furnishing, prescribing, or
administering drugs for other than legal and
legitimate therapeutic purposes,” as that clause is
used in division (B)(3) of section 4731.22 of the
Revised Code; and “a departure from, or the
failure to conform to, minimal standards of care of
similar practitioners under the same or similar
circumstances, whether or not actual injury to a
patient is established,” as that clause is used in
division (B)(6) of section 4731.22 of the Revised
Code.
Effective: 11-17-86; 10-31-98; 6-30-00
Rule Review Date: 12/16/99, 6/30/05
4731-11-05 Use of drugs to enhance athletic
ability.
(A) A physician shall not utilize anabolic steroids,
growth hormones, testosterone or its analogs,
human chorionic gonadotropin (HCG), or other
Controlled Substances
Chapter 4731-11, Ohio Administrative Code
hormones for the purpose of enhancing athletic
ability.
(B) A physician shall complete and maintain
patient medical records which accurately reflect
the utilization of any substance or drug described
in this rule. Patient medical records shall indicate
the diagnosis and purpose for which the
substance or drug is utilized, and any additional
information upon which the diagnosis is based.
(C) A violation of any provision of this rule, as
determined by the board, shall constitute “failure
to maintain minimal standards applicable to the
selection or administration of drugs,” as that
clause is used in division (B)(2) of section
4731.22 of the Revised Code; and “a departure
from, or the failure to conform to, minimal
standards of care of similar practitioners under
the same or similar circumstances, whether or
not actual injury to a patient is established,” as
that clause is used in division (B)(6) of section
4731.22 of the Revised Code. A violation of
paragraph (A) of this rule shall further constitute
“selling, giving away, personally furnishing,
prescribing, or administering drugs for other than
legal and legitimate therapeutic purposes,” as
that clause is used in division (B)(3) of section
4731.22 of the Revised Code.
Review dates: 06/06/2008 and 06/06/2013
Prior Effective Dates: 2/1/88; 9/1/00
4731-11-07 Research utilizing controlled
substances.
The provisions of this chapter of the
Administrative Code shall not apply to or in any
way prohibit research conducted under the
auspices of an accredited medical school, or
research which meets both of the following
conditions:
(1) The research is conducted in conformance
with the approval granted by an institutional
review board of a hospital or medical center
accredited by the JCAHO or other accrediting
body approved by the board; and
(2) The U.S. food and drug administration has
approved an investigational new drug (IND)
application for the research or has notified the
researchers that the proposed study is
exempt from the IND regulations.
Review dates: 06/06/2008 and 06/06/2013
Prior Effective Dates: 12/1/94
4731-11-08 Utilizing controlled substances for
self and family members.
(A) Accepted and prevailing standards of care
presuppose a professional relationship between
a patient and physician when the physician is
utilizing controlled substances. By definition, a
physician may never have such a relationship
with himself or herself. Thus, a physician may not
self-prescribe or self-administer controlled
substances. This paragraph does not prohibit a
physician from obtaining a schedule V controlled
substance for personal use in conformance with
state and federal laws, in the same manner that a
non-physician may obtain a schedule V
controlled substance.
(B) Accepted and prevailing standards of care
require that a physician maintain detached
professional judgment when utilizing controlled
substances in the treatment of family members. A
physician shall utilize controlled substances when
treating a family member only in an emergency
situation which shall be documented in the
patient’s record.
(C) For purposes of this rule, “family member”
means a spouse, parent, child, sibling or other
individual in relation to whom a physician’s
personal or emotional involvement may render
that physician unable to exercise detached
professional judgment in reaching diagnostic or
therapeutic decisions.
Effective: 09/30/2008
Review dates: 06/06/2008 and 09/30/2013
Prior Effective Dates: 11/11/98; 3/15/01
4731-11-09 Prescribing to persons not seen
by the physician.
(A) 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.
Controlled Substances
Chapter 4731-11, Ohio Administrative Code
(B) 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 dangerous drug which
is not a controlled substance to a person who the
physician has never personally physically
examined and diagnosed, except in accordance
with the following requirements:
if the physician has scheduled or is in the
process of scheduling an appointment to
examine the patient and the drugs are
intended to be used pending that
appointment;
(3) The provision of controlled substances or
dangerous drugs by emergency medical
squad personnel, nurses, or other
appropriately trained and licensed individuals,
in accordance with protocols approved by the
state board of pharmacy pursuant to rule
4729-5-01 of the Administrative Code; or
(1) The physician is providing care in
consultation with another physician who has
an ongoing professional relationship with the
patient, and who has agreed to supervise the
patient’s use of the drug or drugs to be
provided; and
(4) The provision of controlled substances or
dangerous drugs by a nurse practicing in
accordance with a standard care arrangement
that meets the requirements of Chapter 4723.
of the Revised Code and rules promulgated
by the board of nursing pursuant thereto.
(2) The physician’s care of the patient meets
all applicable standards of care and all
applicable statutory and regulatory
requirements.
(5) The provision of controlled substances or
dangerous drugs by a physician who is a
medical director or hospice physician of a
hospice program licensed pursuant to
Chapter 3712. of the Revised Code, to a
patient who is enrolled in that hospice
program. This paragraph does not authorize
or legitimize practices that would violate other
applicable standards or legal requirements.
(C) A physician shall not advertise or offer, or
permit the physician’s name or certificate to be
used in an advertisement or offer, to provide any
dangerous drug in a manner that would violate
paragraph (A) or paragraph (B) of this rule.
(D) Paragraphs (A) and (B) of this rule do not
apply to or prohibit the provision of drugs to a
person who is admitted as an inpatient to or is a
resident of an institutional facility. For purposes of
this rule, “institutional facility” has the same
meaning as in rule 4729-17-01 of the
Administrative Code. This paragraph does not
authorize or legitimize practices that would
violate other applicable standards or legal
requirements.
(E) Paragraphs (A) and (B) of this rule do not
apply to or prohibit:
(1) The provision of controlled substances or
dangerous drugs by a physician to a person
who is a patient of a colleague of the
physician, if the drugs are provided pursuant
to an on call or cross coverage arrangement
between the physicians;
(2) The provision of controlled substances or
dangerous drugs by a physician to a person
who the physician has accepted as a patient,
(F) For purposes of this rule, “controlled
substance” has the same meaning as in section
3719.01 of the Revised Code.
(G) For purposes of this rule, “dangerous drug”
has the same meaning as in section 4729.01 of
the Revised Code.
(H) A violation of any provision of this rule, as
determined by the board, shall constitute “failure
to maintain minimal standards applicable to the
selection or administration of drugs,” as that
clause is used in division (B)(2) of section
4731.22 of the Revised Code; “selling,
prescribing, giving away, or administering drugs
for other than legal and legitimate therapeutic
purposes,” as that clause is used in division
(B)(3) of section 4731.22 of the Revised Code;
and “a departure from, or the failure to conform
to, minimal standards of care of similar
practitioners under the same or similar
circumstances, whether or not actual injury to a
patient is established,” as that clause is used in
division (B)(6) of section 4731.22 of the Revised
Code.
Controlled Substances
Chapter 4731-11, Ohio Administrative Code
Effective: 08/31/2006
Review dates: 05/18/2006 and 08/31/2011
Prior Effective Dates: 10/1/99
Drug Treatment of Intractable Pain
Chapter 4731-21, Ohio Administrative Code
4731-21-01 Definitions.
As used in Chapter 4731-21 of the Administrative
Code:
medication characterized by the development of
a withdrawal syndrome following abrupt
cessation of a drug or on administration of an
antagonist.
(J) “Practitioner” means any of the following:
(A) “Addiction” means a compulsive disorder in
which an individual becomes preoccupied with
obtaining and using a substance, despite adverse
social, psychological and/or physical
consequences, the continued use of which
results in a decreased quality of life. Physical
dependence alone is not evidence of addiction.
(B) “Believes” or “has reason to believe” does not
require absolute certainty or complete
unquestioning acceptance; but only an opinion
based on reasonable information that a patient is
suffering from addiction or drug abuse or
engaging in diversion of drugs.
(C) “Board” means the state medical board of
Ohio.
(D) “Diversion” means the conveyance of a
prescription drug to a person other than the
person for whom the drug was prescribed or
dispensed by a practitioner.
(E) “Drug abuse” means a maladaptive or
inappropriate use or overuse of a medication.
(F) “Emergency” means an unforeseen
combination of circumstances or the resulting
state that calls for immediate action.
(G) “Intractable pain” means a state of pain that
is determined, after reasonable medical efforts
have been made to relieve the pain or cure its
cause, to have a cause for which no treatment or
cure is possible or for which none has been
found. “Intractable pain” does not include pain
experienced by a patient with a terminal
condition. “Intractable pain” does not include the
treatment of pain associated with a progressive
disease that, in the normal course of progression,
may reasonably be expected to result in a
terminal condition.
(H) “Pain” means an unpleasant sensory and
emotional experience associated with actual or
potential tissue damage, or described in terms of
such damage.
(I) “Physical dependence” means a physiologic
state of adaptation to a specific drug or
(1) An individual holding a certificate to
practice medicine and surgery or osteopathic
medicine and surgery under Chapter 4731. of
the Revised Code;
(2) An individual holding a certificate to
practice podiatric medicine and surgery under
Chapter 4731. of the Revised Code and
practicing within his or her scope of practice
as defined in section 4731.51 of the Revised
Code; or
(3) An individual holding both of the following:
(a) A certificate to practice as a physician
assistant under Chapter 4730. of the
Revised Code and practicing within his or
her scope of practice in compliance with
that chapter; and
(b) A certificate to prescribe under Chapter
4730. of the Revised Code and exercising
physician delegated prescriptive authority
in compliance with that chapter.
(K) “Prescription drug” means a drug which under
state or federal law may be administered or
dispensed only by or upon the order of a
practitioner and includes the term “dangerous
drug” as defined by section 4729.02 of the
Revised Code.
(L) “Protracted basis” means for a period in
excess of twelve continuous weeks.
(M) “Terminal condition” means an irreversible,
incurable, and untreatable condition caused by
disease, illness, or injury, which will likely result in
death. A terminal condition is one in which there
can be no recovery, although there may be
periods of remission.
A terminal condition shall be determined to a
reasonable degree of medical certainty in
accordance with reasonable medical standards
by a patient’s attending medical doctor or doctor
of osteopathic medicine and one other individual
holding a certificate under Chapter 4731. of the
Revised Code to practice medicine and surgery
Drug Treatment of Intractable Pain
Chapter 4731-21, Ohio Administrative Code
or osteopathic medicine and surgery who has
examined the patient.
(N) “Tolerance” means decreasing response to
the same dosage of a prescription drug over time
as a result of physiologic adaptation to that drug.
(O) “Utilizing prescription drugs” means
prescribing, administering, dispensing, supplying,
selling or giving a prescription drug.
Effective: 11/30/2008
Review dates: 11/06/2007 and 11/30/2013
Prior Effective Dates: 11/11/98
4731-21-02 Utilizing prescription drugs for the
treatment of intractable pain.
(A) When utilizing any prescription drug for the
treatment of intractable pain on a protracted
basis or when managing intractable pain with
prescription drugs in amounts or combinations
that may not be appropriate when treating other
medical conditions, a practitioner shall comply
with accepted and prevailing standards of care
which shall include, but not be limited to, the
following:
(1) An initial evaluation of the patient shall be
conducted and documented in the patient’s
record that includes a relevant history,
including complete medical, pain, alcohol and
substance abuse histories; an assessment of
the impact of pain on the patient’s physical
and psychological functions; a review of
previous diagnostic studies and previously
utilized therapies; an assessment of
coexisting illnesses, diseases or conditions;
and an appropriate physical examination;
(2) A medical diagnosis shall be established
and documented in the patient’s medical
record that indicates not only the presence of
intractable pain but also the signs, symptoms,
and causes and, if determinable, the nature of
the underlying disease and pain mechanism;
(3) An individualized treatment plan shall be
formulated and documented in the patient’s
medical record. The treatment plan shall
specify the medical justification of the
treatment of intractable pain by utilizing
prescription drugs on a protracted basis or in
amounts or combinations that may not be
appropriate when treating other medical
conditions, the intended role of prescription
drug therapy within the overall plan, and,
when applicable, documentation that other
medically reasonable treatments for relief of
the patient’s intractable pain have been
offered or attempted without adequate or
reasonable success. The prescription drug
therapy shall be tailored to the individual
medical needs of each patient. The
practitioner shall document the patient’s
response to treatment and, as necessary,
modify the treatment plan;
(4)(a) The practitioner’s diagnosis of
intractable pain shall be made after having
the patient evaluated by one or more other
practitioners who specialize in the
treatment of the anatomic area, system, or
organ of the body perceived as the source
of the pain. For purposes of this rule, a
practitioner “specializes” if the practitioner
limits the whole or part of his or her
practice, and is qualified by advanced
training or experience to so limit his or her
practice, to the particular anatomic area,
system, or organ of the body perceived as
the source of the pain. The evaluation
shall include review of all available
medical records of prior treatment of the
intractable pain or the condition underlying
the intractable pain; a thorough history
and physical examination; and testing as
required by accepted and prevailing
standards of care. The practitioner shall
maintain a copy of any report made by any
practitioner to whom referral for evaluation
was made under this paragraph. A
practitioner shall not provide an evaluation
under this paragraph if that practitioner
would be prohibited by sections 4731.65
to 4731.69 of the Revised Code or any
other rule adopted by the board from
providing a designated health service
upon referral by the treating practitioner;
and
(b) The practitioner shall not be required to
obtain such an evaluation, if the
practitioner obtains a copy of medical
records or a detailed written summary
thereof showing that the patient has been
evaluated and treated within a reasonable
period of time by one or more other
practitioners who specialize in the
treatment of the anatomic area, system, or
organ of the body perceived as the source
of the pain and the treating practitioner is
satisfied that he or she can rely on that
evaluation for purposes of meeting the
Drug Treatment of Intractable Pain
Chapter 4731-21, Ohio Administrative Code
further requirements of this chapter of the
Administrative Code. The practitioner shall
obtain and review all available medical
records or detailed written summaries
thereof of prior treatment of the intractable
pain or the condition underlying the
intractable pain. The practitioner shall
maintain a copy of any record or report of
any practitioner on which the practitioner
relied for purposes of meeting the
requirements under this paragraph; and
(5) The practitioner shall ensure and
document in the patient’s record that the
patient or other individual who has the
authority to provide consent to treatment on
behalf of that patient gives consent to
treatment after being informed of the benefits
and risks of receiving prescription drug
therapy on a protracted basis or in amounts or
combinations that may not be appropriate
when treating other medical conditions, and
after being informed of available treatment
alternatives.
(B) Upon completion and satisfaction of the
conditions prescribed in paragraph (A) of this
rule, and upon a practitioner’s judgment that the
continued utilization of prescription drugs is
medically warranted for the treatment of
intractable pain, a practitioner may utilize
prescription drugs on a protracted basis or in
amounts or combinations that may not be
appropriate when treating other medical
conditions, provided that the practitioner
continues to adhere to accepted and prevailing
standards of care which shall include, but not be
limited to, the following:
(1) Patients shall be seen by the practitioner
at appropriate periodic intervals to assess the
efficacy of treatment, assure that prescription
drug therapy remains indicated, evaluate the
patient’s progress toward treatment objectives
and note any adverse drug effects. During
each visit, attention shall be given to changes
in the patient’s ability to function or to the
patient’s quality of life as a result of
prescription drug usage, as well as indications
of possible addiction, drug abuse or diversion.
Compliance with this paragraph of the rule
shall be documented in the patient’s medical
record;
(2) Some patients with intractable pain may
be at risk of developing increasing
prescription drug consumption without
improvement in functional status. Subjective
reports by the patient should be supported by
objective data. Objective measures in the
patient’s condition are determined by an
ongoing assessment of the patient’s
functional status, including the ability to
engage in work or other gainful activities, the
pain intensity and its interference with
activities of daily living, quality of family life
and social activities, and physical activity of
the patient. Compliance with this paragraph of
the rule shall be documented in the patient’s
medical record;
(3) Based on evidence or behavioral
indications of addiction or drug abuse, the
practitioner may obtain a drug screen on the
patient. It is within the practitioner’s discretion
to decide the nature of the screen and which
type of drug(s) to be screened. If the
practitioner obtains a drug screen for the
reasons described in this paragraph, the
practitioner shall document the results of the
drug screen in the patient’s medical record. If
the patient refuses to consent to a drug
screen ordered by the practitioner, the
practitioner shall make a referral as provided
in paragraph (C) of this rule;
(4) The practitioner shall document in the
patient’s medical record the medical necessity
for utilizing more than one controlled
substance in the management of a patient’s
intractable pain; and
(5) The practitioner shall document in the
patient’s medical record the name and
address of the patient to or for whom the
prescription drugs were prescribed,
dispensed, or administered, the dates on
which prescription drugs were prescribed,
dispensed, or administered, and the amounts
and dosage forms of the prescription drugs
prescribed, dispensed, or administered,
including refills.
(C) If the practitioner believes or has reason to
believe that the patient is suffering from addiction
or drug abuse, the practitioner shall immediately
consult with an addiction medicine specialist or
other substance abuse professional to obtain
formal assessment of addiction or drug abuse.
(1) For purposes of this rule:
(a) Addiction medicine specialist means a
physician who is qualified by advanced
formal training in addiction medicine or
Drug Treatment of Intractable Pain
Chapter 4731-21, Ohio Administrative Code
other substance abuse specialty, and
includes a medical doctor or doctor of
osteopathic medicine who is certified by a
specialty examining board to so limit the
whole or part of his or her practice.
(b) Substance abuse professional includes
a psychologist licensed pursuant to
Chapter 4732. of the Revised Code and
certified as a clinical health psychologist,
an independent chemical dependency
counselor, or a chemical dependency
counselor III.
(2) The practitioner shall do all of the
following:
(a) Document the recommendations of the
consultation in the patient’s record;
(b) Continue to actively monitor the patient
for signs and symptoms of addiction, drug
abuse or diversion; and
(c) Maintain a copy of any written report
made by the addiction medicine specialist
or substance abuse professional to whom
referral for evaluation was made under
this paragraph.
(3) Prescription drug therapy may be
continued consistent with the
recommendations of the consultation. If the
consulting addiction medicine specialist or
other substance abuse professional believes
the patient to be suffering from addiction or
drug abuse, prompt referral shall be made to
one of the following:
(a) An addiction medicine specialist or
substance abuse professional; or
(b) An addiction medicine or substance
abuse treatment facility.
Effective: 11/30/2008
Review dates: 11/06/2007 and 11/30/2013
Prior Effective Dates: 11/11/98
4731-21-03 Continuing Medical Education.
The board encourages those practitioners who
encounter patients with intractable pain in the
usual course of their practices to complete
continuing medical education related to the
treatment of intractable pain, including
coursework related to pharmacology, alternative
methods of pain management and treatment, and
addiction medicine.
Review dates: 11/06/2007 and 11/06/2012
Prior Effective Dates: 11/11/03
4731-21-04 Tolerance, Physical Dependence
and Addiction.
(A) Physical dependence and tolerance by
themselves do not indicate addiction.
(B) Physical dependence and tolerance are
normal physiological consequences of extended
opioid therapy, and do not, in the absence of
other indicators of drug abuse or addiction,
require reduction or cessation of opioid therapy.
Review dates: 11/06/2007 and 11/06/2012
Prior Effective Dates: 11/11/98
4731-21-05 Violations.
A violation of any provision of any rule in this
chapter of the Administrative Code, as
determined by the board, shall constitute “failure
to use reasonable care discrimination in the
administration of drugs,” as that clause is used in
division (B)(2) of section 4731.22 of the Revised
Code; “selling, prescribing, giving away, or
administering drugs for other than legal and
legitimate therapeutic purposes,” as that clause is
used in division (B)(3) of section 4731.22 of the
Revised Code, if done knowingly or recklessly, as
those words are defined in section 2901.22 of the
Revised Code; and “a departure from, or the
failure to conform to, minimal standards of care of
similar practitioners under the same or similar
circumstances, whether or not actual injury to a
patient is established,” as that clause is used in
division (B)(6) of section 4731.22 of the Revised
Code.
Review dates: 11/06/2007 and 11/06/2012
Prior Effective Dates: 11/11/98
4731-21-06 Exceptions.
(A) A practitioner who treats pain by utilizing
prescription drugs is not subject to disciplinary
action pursuant to this chapter of the
Administrative Code under the following
circumstances:
Drug Treatment of Intractable Pain
Chapter 4731-21, Ohio Administrative Code
(1) The treatment of pain for a patient with a
terminal condition:
(2) The treatment of pain associated with a
progressive disease that, in the normal course
of progression, may reasonably be expected
to result in a terminal condition;
(3) Treatment utilizing only drugs that do not
exert their effects at the central nervous
system level; and
(4) Treatment utilizing only drugs that are not
controlled substances and are classified as
antidepressants.
(B) A practitioner who treats intractable pain by
utilizing prescription drugs is not subject to
disciplinary action by the board under section
4731.22 of the Revised Code solely because the
practitioner treated the intractable pain with
prescription drugs. The practitioner is subject to
disciplinary action only if the prescription drugs
are not utilized in accordance with section
4731.052 of the Revised Code and the rules
adopted under this chapter of the Administrative
Code.
(C) A Medical doctor or doctor of osteopathic
medicine who provides comfort care as described
in division (E)(1) of section 2133.12 of the
Revised Code to a patient with a terminal
condition is not subject to disciplinary action by
the board under section 4731.22 of the Revised
Code if the treatment of pain for a patient with a
terminal condition is provided pursuant to the
requirements of section 2133.11 of the Revised
Code.
Review dates: 11/06/2007 and 11/06/2012
Prior Effective Dates: 11/11/98