1. Draft Regulations for Pain Management William L. Harp, MD, Executive Director Virginia Board of Medicine PMP Conference Richmond, VA November 16, 2007

2. www.dhp.virginia.gov  Protect the public  Facilitate good care Mission of a Medical Board

3. www.dhp.virginia.gov  Laws  Regulations/rules  Guidance documents/position statements Creature of Statute

4. www.dhp.virginia.gov  Unprofessional conduct law  Prescribing of controlled substances Laws

5. www.dhp.virginia.gov §54.1-2915(A)(8)  Prescribing or dispensing controlled substances with intent or knowledge that it will be used for other than a medicinal purpose or with intent to evade any law with respect to the sale, use or disposition of such drug

6. www.dhp.virginia.gov § 54.1-2915 (A)(13)  Conducting his practice in such a manner as to be a danger to the health and welfare of patients or to the public

7. www.dhp.virginia.gov §54.1-2915(A)(16)  Performing any act likely to deceive, defraud, or harm the public

8. www.dhp.virginia.gov §54.1-2915(A)(17)  Violating any statute or regulation, state or federal, relating to the manufacture, distribution, dispensing or administration of drugs

9. www.dhp.virginia.gov Regulations  None presently  Proposed regulations in progress

10. www.dhp.virginia.gov Guidance Documents  Board of Medicine Guidance Document 85-24  FSMB model policy for the use of controlled substances for the treatment of pain

11. www.dhp.virginia.gov Pain Management  Championed by specialists  Practiced by generalists

12. www.dhp.virginia.gov Attendant Issues  Physiologic dependence  Addiction-behavior demonstrative of impaired judgment and continued compulsive overuse of the substance  Diversion

13. www.dhp.virginia.gov Opioid Problems in Virginia  High profile cases  Purdue Frederick Company, Inc.  Dr. William Hurwitz

14. www.dhp.virginia.gov Virginia Board Complaints/Violations  Complaint-driven disciplinary system  Complaints don’t necessarily pan out as violations

15. www.dhp.virginia.gov Fiscal Yr. 2006 Top Complaint Categories:  Required Report Not Filed (598)  Standard of Care – Treatment-Related (442)  Standard of Care – Diagnosis-Related (186)  Standard of Care - Other (155)  Standard of Care - Malpractice Reports (145)  Business Practices/Issues (130)

16. www.dhp.virginia.gov Fiscal Yr. 2007 Top Complaint Categories  Standard of Care – Treatment-Related (400)  Required Report Not Filed (278)  Standard of Care - Other (198)  Standard of Care - MMP Report (174)  Standard of Care – Diagnosis-Related (153)  Business Practices/Issues (147)

17. www.dhp.virginia.gov Fiscal Yr. 2006 Top Violations:  Unlicensed Activity (39)  Action by another Board (18)  Drug-Excessive Rx (17)  Required Report Not Filed (15)  Criminal Convictions (13)

18. www.dhp.virginia.gov Fiscal Yr. 2007 Top Violations:  Drug-Excessive Rxing (26)  Unlicensed Activity (26)  Criminal Conviction (20)  Action by another Bd (17)  SOC-Treatment (13)

19. www.dhp.virginia.gov MEDICAL EXAMINER DATA ON METHADONE DEATHS  1998-5  1999-9  2000-19  2001-49  2002-62  2003-88  2004-69  2005-70  2006-78

20. www.dhp.virginia.gov Southwest Virginia  Martha Wunsch, MD, Edward Via College of Osteopathic Medicine  243 methadone cases in rural Virginia

21. www.dhp.virginia.gov Prescribing Opioids  Risky business  Ideally…knowledgeable prescriber that writes methadone appropriately, educates his/her patient and the patient complies

22. www.dhp.virginia.gov Breakdowns  Prescriber lacks knowledge  Prescriber lacks diligence  Prescriber doesn’t educate  Pharmacist doesn’t educate  Patient doesn’t comply……Accidental death

23. www.dhp.virginia.gov Prescriber Factors  Prescriber lacks knowledge/diligence  Prescribing for other than medicinal reasons

24. www.dhp.virginia.gov Towards a Solution  Three-pronged approach  Education  Treatment  Enforcement

25. www.dhp.virginia.gov Board of Medicine  Continued enforcement of the laws and regulations, especially for the less than diligent  Regulations on pain management and prescribing to provide clarity  Greater use of the prescription monitoring program (PMP)

26. www.dhp.virginia.gov Treatment of Pain with Controlled Substances A. Definitions. For purposes of this section, the following words and terms shall have the following meanings:  “Acute pain” shall mean pain that occurs within the normal course of a disease or condition or as the result of surgery, for which controlled substances may be prescribed for no more than six months.  “Chronic pain” shall mean non-malignant pain that goes beyond the normal course of a disease or condition, for which controlled substances may be prescribed for a period greater than six months.  “Controlled substance” shall mean drugs listed in The Drug Control Act of the Code of Virginia in Schedules II through IV.  “Prescription Monitoring Program” shall mean the electronic system within the Department of Health Professions that monitors the dispensing of certain controlled substances.

27. www.dhp.virginia.gov Treatment of Pain with Controlled Substances B. Treatment of acute pain  1. Evaluation of the patient. Prior to initiating treatment with a controlled substance for a complaint of acute pain, the prescriber shall perform a history and physical examination appropriate to the complaint.  2. Medical records. The medical record shall include a description of the pain, a presumptive diagnosis for the origin of the pain, an examination appropriate to the complaint, a treatment plan and the medication prescribed (including date, type, dosage and quantity prescribed).

28. www.dhp.virginia.gov Treatment of Pain with Controlled Substances C.Management of chronic pain 1. Evaluation of the patient Prior to initiating management of chronic pain with a controlled substance, a medical history and physical examination shall be performed and documented in the medical record, including: a) the nature and intensity of the pain; b) current and past treatments for pain; c) underlying or coexisting diseases or conditions; d) the effect of the pain on physical and psychological and social function; e) psychiatric, addiction and substance abuse history of the patient and his family; f) and a urine drug screen. The medical record also shall document the presence of one or more recognized medical indications for the use of a controlled substance.

29. www.dhp.virginia.gov Treatment of Pain with Controlled Substances 2. Treatment plan. The medical record shall include a treatment plan that states measures to be used to determine progress in treatment, including but not limited to pain relief and improved physical and psychosocial function. The treatment plan shall include further diagnostic evaluations and other treatment modalities or rehabilitation that may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment. The prescriber shall record in the patient records the presence or absence of any indicators for medication misuse, abuse or diversion

30. www.dhp.virginia.gov Treatment of Pain with Controlled Substances 3. Informed consent and agreement for treatment.  The prescriber shall document in the medical record informed consent, to include risks, benefits and alternative approaches, prior to the initiation of opioids for chronic pain. There shall be a written treatment agreement in the medical record that addresses the parameters of treatment, including those behaviors which will result in a cessation of treatment or dismissal from care. The treatment agreement shall include, but not be limited to permission for the practitioner to: a) obtain urine/serum medication levels, when requested; b) query and receive reports from the Prescription Monitoring Program; and c) consult with other prescribers or dispensing pharmacists for the patient.

31. www.dhp.virginia.gov Treatment of Pain with Controlled Substances 4. Periodic review.  The prescriber shall review the course of pain treatment and any new information about the etiology of the pain or the patient’s state of health at least every 90 days. Continuation of treatment with controlled substances shall be supported by documentation of continued benefit by the prescriber. If the patient’s progress is unsatisfactory, the prescriber shall assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.

32. www.dhp.virginia.gov Treatment of Pain with Controlled Substances 5. Consultation.  When necessary to achieve treatment goals, the prescriber shall refer the patient for additional evaluation and treatment.

33. www.dhp.virginia.gov Treatment of Pain with Controlled Substances 6. Medical records. The prescriber shall keep current, accurate and complete records in an accessible manner and readily available for review to include: a. The medical history and physical examination; b. Past medical history; c. Records from prior treatment providers; d. Diagnostic, therapeutic and laboratory results; e. Evaluations and consultations; f. Treatment goals; g. Discussion of risks and benefits; h. Informed consent and agreement for treatment;

34. www.dhp.virginia.gov Treatment of Pain with Controlled Substances Medical records (cont.) i. Treatments; j. Medications (including date, type, dosage and quantity prescribed). During the course of treatment, the physician shall adjust drug therapy to the individual medical needs of the patient and record the rationale for adjustments. Records shall document the medical necessity for any prescriptions in excess of recommended dosage in accordance with §§ 54.1-2971.01 and 54.1-3408.1 of the Code of Virginia; 54.1-2971.0154.1-3408.1 k. Instructions and agreements; and l. Periodic reviews.

35. www.dhp.virginia.gov