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Pain Management: a Regulatory Perspective. William J. Schmidt, J.D . Senior Counsel, Investigations, Compliance & Enforcement Randy Beck Investigative Supervisor State Medical Board of Ohio. OVERVIEW. Organization of Medical Board Key provisions of pain management statutes & rules.

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Pain management a regulatory perspective l.jpg

Pain Management:a Regulatory Perspective

William J. Schmidt, J.D.

Senior Counsel, Investigations, Compliance & Enforcement

Randy Beck

Investigative Supervisor

State Medical Board of Ohio


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OVERVIEW

  • Organization of Medical Board

  • Key provisions of pain management statutes & rules


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State Medical Board of Ohio

The Medical Board is a state regulatory agency

founded in 1896


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Board Organization

To protect and enhance the health

and safety of the public through

effective medical regulation

Mission


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Structure

Board Organization

12 members appointed by Governor to staggered five-year terms; may be reappointed

7 MD’s, 1 DO, 1 DPM, and 3 consumer representatives

Monthly meetings in Columbus


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Operations

Board Organization

  • 87 full time employees

  • $ 8 million plus annual operating budget funded solely by licensing & renewal fees

  • No money from general revenue fund


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Approximately 60,000 professionals*, including

MEDICAL BOARD LICENSEES

* and c*and coming soon… Radiologist Assistants

Data as of 12-31-08


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Regulatory Authority

STATUTES - Chapters 4730, 4731, 4760, 4762 & 4774, Ohio Revised Code

RULES - Chapters 4730, 4731 & 4774

Ohio Administrative Code

Medical Board interprets & enforces

statutes and rules


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The Medical Board’sPain Management Guidelines


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The Medical Board has never taken an action against a physician for the appropriate use of medication


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The Medical Board has never taken an action against a physician for the treatment of cancer pain


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Ohio Intractable physician for the treatment of Pain Statute – October 1997

  • Section 4731.052, Ohio Revised Code

  • Required Medical Board to write rules defining standards & procedures for diagnosing & treating intractable pain


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Ohio Intractable Pain Statute physician for the treatment of

Physician who manages intractable pain with dangerous drugs in accordance with law not subject to Medical Board disciplinary action


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The Medical Board’s physician for the treatment of Pain Management Rules

Chapter 4731-21, O.A.C.


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Medical Board Rules physician for the treatment of

Intractable pain is not

  • Pain associated with a terminal condition, or

  • Pain associated with a disease that may be expected to result in a terminal condition


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Rules do not apply to . . . physician for the treatment of

Treatment using only non-CNS

drugs or antidepressants


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Rules apply only to . . . physician for the treatment of

Treatment on a protracted basis

Use of amounts & combinations of drugs that may not be appropriate in other conditions

For example:

  • Using doses far exceeding PDR’s usual recommended dosage

  • Adding opioids for breakthrough pain


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Requirements for Treating Intractable Pain physician for the treatment of


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Initial Evaluation physician for the treatment of 4731-21-02, O.A.C.

  • Patient history, including alcohol & substance abuse

  • Assessment of pain impact on function

  • Review of previous studies & therapies

  • Assessment of coexisting illnesses

  • Physical exam


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Medical Diagnosis physician for the treatment of

Document presence of intractable pain

Identify signs, symptoms & causes

  • Nature of underlying disease

  • Pain mechanism


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Individualized Treatment Plan physician for the treatment of

Specify medical justification for drugs and role of drug therapy

Document drugs that did not succeed, adjust drug therapy

Document response

Modify treatment plan as necessary


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Evaluation by Specialist physician for the treatment of

  • Must specialize in treatment of anatomic area, system or organ perceived as pain source

  • Evaluator must review prior treatment records & prepare written report

  • Referring physician must keep copy of specialist’s report

  • May assume patient’s care, but usually acts as a consultant


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Evaluation not required … physician for the treatment of

if patient had prior satisfactory evaluation within reasonable time

if treating physician has records of prior evaluation


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Informed Consent physician for the treatment of

  • Obtain from patient or person having authority to consent

  • Inform of benefits & risks of treatment

  • Inform of treatment alternatives

  • Document in patient record


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Be Sure to Document physician for the treatment of

  • need for using more than one controlled substance in pain treatment

  • patient’s name & address, dates, amounts, dosage forms & refills of all prescription drugs

    Consider use of duplicate prescription forms


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Other Considerations physician for the treatment of

  • Consider Pain Contract with patient

    • Consequences of non-compliance

    • Expectation of refills & follow-up visits

  • Consider urine sample for drug screening to confirm patient’s use

  • Ohio Automated Prescription Reporting System (OARRS) report


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OARRS physician for the treatment of

  • Ohio Automated Prescription Reporting System, a prescription monitoring program overseen by Ohio Board of Pharmacy

  • OARRS contains dispensing information for all controlled substances, carisoprodol products and tramadol products within the past 2 years

  • Physicians may register for OARRS access to review patient prescription history reports


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OARRS Registration physician for the treatment of

www.ohiopmp.gov for registration information to obtain a user name and password

Patient prescribing report requested on-line; data from January 1, 2006 provided; turn around time is about 15 minutes for report

Approximate 25 day lag time in data entry, as pharmacies send dispensing reports to OARRS twice a month


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Patient Follow-Up physician for the treatment of

  • Periodically assess treatment efficacy

  • Assure drug therapy still indicated

  • Evaluate progress toward treatment objectives

  • Note functional ability & quality of life

  • Consider drug screens

  • Consider OARRS report review


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Obtain Objective Measures physician for the treatment of

  • Ability to engage in work

  • Pain intensity & interference with life

  • Family & social activities

  • Physical activity


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Suspected drug abuse? physician for the treatment of

Physician may obtain a drug screen if there are indications of drug abuse

Consult with substance abuse specialist


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If drug abuse suspected physician for the treatment of

  • Continue therapy consistent with specialist’s recommendations

  • Refer patient to substance abuse specialist if recommended

  • Continue to monitor for signs of abuse

  • Keep copy of any report from consultant

  • If termination of patient is considered, refer to

    Rule 4731-27, OAC


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Tolerance and physical dependence do not physician for the treatment of always equal addiction or require cessation of opioid therapy


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med.ohio.gov physician for the treatment of

Medical Board website has links to:

Pain Rules (Chapter 4731-21, OAC)

Policy – Office-based Treatment of Opioid Addiction


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State Medical Board of Ohio physician for the treatment of

30 E. Broad St. 3rd Floor

Columbus, OH 43215-6127

Phone: 614-466-3934

FAX: 614-728-5946

MED.OHIO.GOV


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