pain management: a regulatory perspective william j. schmidt, j.d. senior counsel, investigations,...

Pain Pain Management:Management:

a Regulatory a Regulatory PerspectivePerspectiveWilliam J. Schmidt, J.D.

Senior Counsel, Investigations, Compliance & Enforcement

Randy BeckInvestigative Supervisor

State Medical Board of Ohio

OVERVIEWOVERVIEW• Organization of Medical Board

• Key provisions of pain management statutes & rules

State Medical Board of OhioState Medical Board of Ohio

The Medical Board is

a state regulatory

agency

founded in 1896

Board OrganizationBoard Organization

To protect and enhance the health

and safety of the public through

effective medical regulation

Mission

Structure

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

Board OrganizationBoard Organization

Operations

• 87 full time employees

• $ 8 million plus annual operating

budget funded solely by licensing &

renewal fees

• No money from general revenue fund

Board OrganizationBoard Organization

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

MEDICAL BOARD LICENSEESMEDICAL BOARD LICENSEES

* and c*and coming soon… Radiologist Assistants Data as of 12-31-08

Regulatory AuthorityRegulatory 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 The Medical Board’sBoard’s

Pain Management Pain Management GuidelinesGuidelines

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

medication

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

pain

Ohio Intractable Ohio Intractable Pain Statute – October 1997Pain 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 StatuteOhio Intractable Pain Statute

Physician who manages

intractable pain with dangerous

drugs in accordance with law not

subject to Medical Board

disciplinary action

The Medical The Medical Board’sBoard’s

Pain Management Pain Management RulesRules

Chapter 4731-21, O.A.C.

Medical Board RulesMedical Board Rules

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

Rules do not apply to . . .Rules do not apply to . . .

Treatment using only non-CNS

drugs or antidepressants

Rules apply only to . . .Rules apply only to . . .

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

Requirements for Requirements for Treating Intractable PainTreating Intractable Pain

Initial Evaluation Initial Evaluation 4731-21-02, O.A.C4731-21-02, 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 DiagnosisMedical Diagnosis

Document presence of intractable pain

Identify signs, symptoms & causes

• Nature of underlying disease• Pain mechanism

Individualized Treatment PlanIndividualized 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 SpecialistEvaluation 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 report

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

Evaluation not required …Evaluation not required …

if patient had prior satisfactory evaluation within reasonable time

if treating physician has records of prior evaluation

Informed ConsentInformed Consent

• Obtain from patient or person having authority to consent

• Inform of benefits & risks of treatment

• Inform of treatment alternatives

• Document in patient record

• 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

Be Sure to DocumentBe Sure to Document

Other ConsiderationsOther 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

OARRSOARRS

• 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 RegistrationOARRS Registration

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

Patient Follow-UpPatient 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 MeasuresObtain Objective Measures

• Ability to engage in work

• Pain intensity & interference with life

• Family & social activities

• Physical activity

Suspected drug abuse?Suspected drug abuse?

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

Consult with substance abuse specialist

If drug abuse suspected If drug abuse suspected

• 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

Tolerance and physical dependence do not

always equal addiction or require cessation

of opioid therapy

med.ohio.govmed.ohio.gov

Medical Board website has links to:

Pain Rules (Chapter 4731-21, OAC)

Policy – Office-based Treatment of Opioid Addiction

State Medical Board of State Medical Board of OhioOhio

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

Phone: 614-466-3934

FAX: 614-728-5946

MED.OHIO.GOV