Pain Pain Management: Management: a Regulatory a Regulatory Perspective Perspective William J. Schmidt, J.D. Senior Counsel, Investigations, Compliance & Enforcement Randy Beck Investigative Supervisor State Medical Board of Ohio
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