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PAIN MANAGEMENT Powered By Docstoc
					Pain Management:
a Regulatory Perspective
     William J. Schmidt, J.D.
Senior Counsel, Investigations, Compliance &
             Randy Beck
          Investigative Supervisor
   State Medical Board of Ohio
• Organization of Medical Board

• Key provisions of pain
  management statutes & rules
  State Medical Board of Ohio

The Medical Board is
  a state regulatory
  founded in 1896
       Board Organization
To protect and enhance the health
 and safety of the public through
   effective medical regulation
      Board Organization
12 members appointed by Governor to
staggered five-year terms; may be
   7 MD’s, 1 DO, 1 DPM, and 3 consumer
Monthly meetings in Columbus
        Board Organization
  • 87 full time employees
  • $ 8 million plus annual operating
    budget funded solely by licensing &
    renewal fees
  • No money from general revenue fund
Approximately 60,000 professionals*, including

 Medical Doctors       MD                            35,872
 Doctors of Osteopathic Medicine        DO             4,788
 Doctors of Podiatric Medicine         DPM              956
 Licensed Massage Therapists        LMT              10,699
 Physician Assistants PA                               1,886
 Anesthesiologist Assistants      AA                    129
 Acupuncturists        A or RAC                         147
 Cosmetic Therapists        CT                          209
 Doctors in training                                   5,214
 Data as of 12-31-08
          * and c*and coming soon… Radiologist Assistants
 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
The Medical Board’s
 Pain Management
The Medical Board has never
 taken an action against a
     physician for the
    appropriate use of
The Medical Board has never
  taken an action against a
 physician for the treatment
       of cancer pain
         Ohio Intractable
   Pain Statute – October 1997

• Section 4731.052, Ohio Revised Code

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

     Physician who manages
 intractable pain with dangerous
drugs in accordance with law not
     subject to Medical Board
        disciplinary action
The Medical Board’s
 Pain Management

Chapter 4731-21, O.A.C.
       Medical Board Rules

Intractable pain is not
 – Pain associated with a terminal condition,
 – Pain associated with a disease that may
   be expected to result in a terminal
Rules do not apply to . . .

  Treatment using only non-CNS

    drugs or antidepressants
Rules apply only to . . .
Treatment on a protracted basis

Use of amounts & combinations of drugs
that may not be appropriate in other
     For example:

     •   Using doses far exceeding PDR’s usual
         recommended dosage

     •   Adding opioids for breakthrough pain
   Requirements for
Treating Intractable Pain
       Initial Evaluation
         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
      Medical Diagnosis
Document presence of intractable pain

Identify signs, symptoms & causes
  • Nature of underlying disease
  • Pain mechanism
Individualized Treatment Plan

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
       Evaluation by Specialist

• 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

• May assume patient’s care, but usually acts as a
Evaluation not required …
if patient had prior satisfactory
evaluation within reasonable time

if treating physician has records of
prior evaluation
       Informed Consent
• Obtain from patient or person having
  authority to consent
• Inform of benefits & risks of treatment
• Inform of treatment alternatives
• Document in patient record
        Be Sure to Document

•   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
     Other Considerations
• 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
• 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
       OARRS Registration 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
           Patient Follow-Up

• 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
Obtain Objective Measures
•   Ability to engage in work
•   Pain intensity & interference with life
•   Family & social activities
•   Physical activity
  Suspected drug abuse?

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

Consult with substance abuse
     If drug abuse suspected
• Continue therapy consistent with specialist’s
• Refer patient to substance abuse specialist if
• 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
Tolerance and physical
  dependence do not
always equal addiction
  or require cessation
   of opioid therapy

Medical Board website has links to:

  Pain Rules (Chapter 4731-21, OAC)
  Policy – Office-based Treatment of Opioid
State Medical Board of Ohio

             30 E. Broad St. 3rd Floor
             Columbus, OH 43215-6127

             Phone:   614-466-3934

             FAX:     614-728-5946


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