PROTECTING DR. SMITH WHILE TREATING THE CHRONIC PAIN OF MRs. JONES: WHY THE INDIANA MEDICAL LICENSING BoARD SHOULD PASS GUIDELINES FOR USING CONTROLLED SUBSTANCES FOR PAIN TREATMENT Macon Jones • "The end of law is not to abolish or restrain, but to preserve and enlarge freedom. For in all the states of created beings, capable of laws, where there is no law, there is no freedom. " -John Locke1 I. INTRODUCTION .......................................... ; .................................... 696 II. BACKGROUND ................................................................................ 699 III. THE CURRENT STATUS OF INTERESTED PARTIES FOR INDIANA'S POLICIES CONCERNING CONTROLLED SUBSTANCE PRESCRIBING FOR PAIN TREATMENT ........................................................................... 701 A. The Patient ............................................................................... 701 B. The Prescribing Physician ....................................................... 703 1. Duty to Treat Patient Pain ................................................ 703 2. Interest in Perpetuating Practice in Medicine .................. 704 C. The Office of the Indiana Attorney General ............................. 706 D. The Indiana Medical Licensing Board ..................................... 708 IV. THE GUIDELINE SOLUTION ............................................................. 709 A. The Model Policy ..................................................................... 709 B. The Michigan Guideline .......................................................... 711 C. Indiana's Attempt to Promulgate a Rule for Using Controlled Substances in 4 Pain Treatment Setting ................................... 713 D. How a Guideline Would Operate Under Indiana's Statutory Scheme ................................................... -.................................. 715 V. THE ROLE OF A GUIDELINE TO ACHIEVE AND BALANCE ALL INTEREST ........................................................................................ 716 A. A Guideline Will Clarify the Law and Create Case Evaluation Criteria ..................................................................................... 717 • J.D. Candidate, 2012, Indiana University RQbert H. McKinney School of Law; B.A., 2005, University ofNorth Florida. 1. JOHN LocKE, THE SBOOND TREATISE OF CML GoVERNMENT CHAP. VI, SEC. 57 (1690). 696 INDIANA HEALTH LAW REVIEW · [Vol. 9:2 1. The Indiana Medical Licensing Board Members Are Not Pain Management Specialists ................... ; .. ; .................... 717 2; The Case of David and Charles Chube ............................. 718 B. Clear Standards Put Physicians on Notice as to Proper Prescribing Practices ............................................................... 722 1. A Guideline Will Alleviate Fear of Regulatory Scrutiny ... 722 2. A Clear Guide Will Enable Proper Defense ...................... 723 C. The Patients Will Receive Better Treatment ............................ 725 VI. THE CASE AGAINST A GUIDELINE .................................................. 725 A. There is No Enforceability With a Guideline ........................... 725 B. Restricts the Practice of Medicine ........................................... 728 C. Specific Standards Are Not Necessary to Achieve Physician Discipline ................................................................................. 729 D. Patient Concern of Required Documentation .......................... 729 Vll. CONCLUSION .................................................................................. 729 I. INTRODUCTION A war is raging; it is one that includes all members of society: the in­ digent, wealthy, young, old, and all flavors of race, nationality, and gender. It is the war on prescription medication. According to the Drug Enforce­ ment Administration ("DEA"), six million Americans currently abuse a prescription drug, which is more than abusers of heroin, cocaine, hallucino­ gens, and inhalants combined.2 1.85 million people are estimated to be de­ pendent on or abusing schedule II controlled substances, also known as opioids.3 In 2009, 1.2 million individuals were treated in an emergency department for conditions involving pharmaceutical drug use, which is a ninety-eight percent increase from 2004.4 This increase is especially star­ tling considering that emergency room treatment involving illicit drugs has remained virtually unchanged over the same period.5 In response, Federal and State governments have taken multiple steps to address this serious and growing problem. On September 25, 2010, the DBA held its first ''National 2. Practitioner's Manual, DRUG ENFoRCEMENT ADMIN. OFFICE OF DIVERSION CoNTROL, http://www.deadiversion.usdoj.gov/pubs/manuals/ptact/sectionl.btm (last visited Mar. 11, 2012). 3. Cynthia Gregorian, Addiction to painkillers hobbles more patients, STL TODAY (Oct. 27; 201 0), http://www.stltoday.comllifestyleslhealth-med-fitlfitnesslarticle _ :ffi777202- 785b-5703-9319-l7df8d32c29b.html. Schedule II controlled substances are beneficial and effective medications that also have a high potential for abuse and addiction, thus, their use is regulated. 21 U.S.C. § 812(bX2)(201l). 4. Abby Goodnough, Prescription Drug Abuse Sends More People to the Hospital, N.Y .. TIMES, Jan. 5, 2011, http://www;nytimes.com/2011/01/06/bealth/06drugs.html?_ r=2&ref=bealth. 5. Id 2012] GUIDELINES FOR USING CONTROLLED SUBSTANCES FOR PAIN 697 Prescription Drug Take Back Day" which allowed anyone to return unused prescription medication with no questions asked 6 This activity was moti­ vated by the desire to reduce the amount of unused medication available for diversion.7 Further, in recent years the DEA has stepped up its investiga­ tions and prosecutions of physicians, especially those who prescribe Oxy­ Contin, a schedule II controlled substance and one of the most widely prescribed and abused opioids. 8 Indiana has a particularly concerning controlled substance abuse prob­ lem. In the most recent Substance Abuse and Mental Health Services Ad­ ministration ("SAMHSA") report, Indiana ranked among the highest in the country for non-medical ~in reliever use in all age groups except ages twelve through seventeen. However, Indiana has also adopted measures to combat prescription drug abuse and diversion, including Indiana's con­ trolled substance monitoring program ("INSPECT" program) created in 2006,10 and the passage by the state legislature of the Prescription Drug Disposal Sites - House Bill 1121,11 which would allow individuals to return unused medications to their pharmacy for proper disposal.12 Also, in the past year the Office of the Indiana Attorney General has prosecuted numer­ ous physicians who divert and improperly prescribe prescription drugs.13 Prescription drug abuse has become a crisis nationally and in Indiana and more safeguards are needed. However, in developing additional safeguards by regulating access to prescription drugs, one must be careful not to unnecessarily restrict access from legitimate users.· While prescription drugs are widely abused, they can also provide life altering relief from pain that cannot otherwise be treated. As a casualty in the war on prescription drug abuse, undertreated pain has quietly become a nationwide epidemic.14 Many factors contribute to under- 6. National Take Back Initiative, DRUG ENFORCE. ADMIN. OFFICE OF DIVERSION CONTROL, http://www.deadiversion.usdoj.gov/drug_disposalltakeback/ (last visited Jan. 17, 2011). 7. ld. 8. Ronald T. Libby, Treating Doctors as Drug Dealers: The DEA 's War on Prescrip­ tion Painkillers, 545 PoL. ANALYSIS 1, 1 (2005), available at http://www.cato.org/pubs/pas/ pa545.pdf. 9. SUBSTANCE ABUSE & MENTAL HEALTH SERVS. ADMIN., U.S. DEP'T OF HEALTH & HUMAN SERVS.,INDIANA, STATES IN BRIEF: SUBSTANCE ABUSE AND MENTAL HEALTH ISSUES AT-A-GLANCE, A SHORT REPORT FROM THE OFFICE OF APPLIED STIJDIES (2009), available at http://www.samhsa.gov/statesinbriet72009/INDIANA_508.pdf. 10. IND. CODE§ 35-48-7-10.1 (2010). 11. H.B. 1121, 117th Gen. Assemb., 1st Reg. Sess. (Ind. 2011), available at http:/ /www.in.gov/legislativelbills/2011/PDFIHBIHB 1121.2.pdf. 12. Press Release, Ind. Att'y Gen., AG, legislators support bill for safe disposal of prescription drugs (Jan. 10, 2011 ), http://www.in.gov/attomeygeneral/2369.htm. 13. See Findings of Fact, Ultimate Findings of Fact, and Order, In the Matter of the License of Beverly P. Edwards, 2009 MLB 0024 (Ind. Med. Licensing Bd.,, Mar. 30, 2010) [hereinafter Edwards, Findings ofFact and Order]. 14. Ben A. Rich, A Prescription for the Pain: The Emerging Standard of Care for 698 INDIANA HEALTH LAW REVIEW [Vol. 9:2 treated pain, but one important influence is physician concern about both law enforcement and regulatory scrutiny: physicians are reluctant to pre­ scribe adequate amounts of controlled substances for pain because of the potential for investigation by the DEA and the state medical licensing board.15 As a result, patients indirectly suffer from amped-up efforts to control prescription drug abuse by focusing on physician prescribing prac­ tices. Therefore, regulations placed on prescription drugs must consider all interests implicated and fashion a strategy that serves to address prescrip­ tion drug abuse while allowing doctors to adequately treat the pain of their patients. This Note will argue that the Indiana Medical Licensing Board should pass guidelines for the use of controlled substances for the treatment of pain. Guidelines would address the ever-increasing concern over prescrip­ tion drug abuse by creating a standard that would allow physicians to pre­ scribe proper amounts of controlled substances for pain treatment without fear of investigation. In addition, guidelines would provide a method for the Office of the Indiana Attorney General to assess and take appropriate action against physicians who use medicine as a pretext for diversion and ultimately are not prescribing for legitimate medical purposes and give the Indiana Medical Licensing Board an evaluation tool to properly scrutinize physician prescribing practices. This Note will consider the interests impli­ cated by the adoption of guidelines for controlled substances in the context of pain treatment including patients, physicians, the Office of the Indiana Attorney General, the Indiana Medical Licensing Board, and Indiana citi­ zens generally. Further, this Note will consider several disciplinary actions and criminal convictions of Indiana physicians who have been disciplined for their prescribing practices and compare Indiana law and regulations with the efforts of Michigan in the area of pain management using controlled substances. This Note concludes that guidelines adopted by the Indiana Medical Licensing Board will serve all interests involved and will amelio­ rate prescription drug abuse and diversion while alleviating undertreated pain and physician fear in Indiana. Pain Management, 26 WM. MITCHELL L. REv. 1, 2 (2000); see also David B. Resnik et al., The Undertreatment of Pain: Scientific, Clinical, . Cultural, and Philosophical Factors, 4 MED. HEALTH CARE PHIL. 277 (2001) (arguing that undertreatment of pain is due to a faulty philosophical approach to pain management); Steven E. Stark, Bio-Ethics and Physician Liability: The Liability Effect of Developing Pain Management Standards, 14 ST. THOMAS L. REv. 601, 638 (2002) ("There is an increasing perceived inability of the medical profession to deliver adequate pain management and adequate palliation of pain to those with acute or chronic illness and to those with terminal illness."); but see Norman Miller et al., Controlled Substance Laws: Are They Meeting the Health Needs of the Public?, 7 MICH. ST. J. MED. & LAW 81, 83 (2003) ("In the past ten years or so, a growing mood of entitlement of absolute pain relief has obscured decades of hard earned wisdom that narcotic medications contain inherent 'pain' ftom their pharmacological effects, and addictive properties that are not ne­ gated by the presence of pain in an individual.''). 15. Aaron Gilson, et al., Improving State Medical Board Policies: ltifluence of a Mod­ el, 31 J.L. MEn. &Ennes 119, 119 (2003). 2012] GUIDELINES FOR USING CoNTROLLED SUBSTANCES FOR PAIN 699 II. BACKGROUND In Indiana, there are two agencies that are involved in regulating the professional practice of physicians~ The Office of the Indiana Attorney General ("AG") is the investigative and prosecutorial arm, 16 and the Indiana Medical Licensing Board ( .. Board") is the entity that licenses and disci­ plines physician practice.17 Any action conducted by these agencies only relates to the physician's license and ability to legally practice medicine in Indiana.18 No criminal penalties are imposed, although a finding of unpro­ fessional conduct allows for discipline on the physician's license.19 The process begins when the AG receives allegations of improper physician conduct, which can come from a variety of sources, including patient com­ plaints~ other state disciplinary committees, media outlets, and the Board itself.2u After receiving this information, the AG conduc~ an investigation of the alleged conduct, including a response to the allegations by the physician in question.21 After a thorough review of the information available, the AG makes a recommendation of the action to be taken and submits it to a mem­ ber of the Board for their comments and impressions. 22 Based on the Board member's comments and in-house attorney recommendations, the AG will then decide whether to file a formal administrative complaint against the physician or close the matter altogether?3 In the event that the AG decides to take action against the physician's license, they will file a formal admin­ istrative complaint with the Board. 24 The complaint will allege that the physician has committed a licensing violation under Indiana Code ("IC") section 25-1-9-4, 25 which is commonly referred to as the Licensing Charg- · ing Statute.26 The physician will then either decide to settle with the AG, subject to the Board's approval; or defend the allegations in an administra­ tive hearing before the Board.2 The AG serves as the prosecution in the 16. IND. CODE§ 25-1-7-7 (2010). 17. IND. CODE § 25-22.5-2-7 (20 1 0). The Board is a subset of the Indiana Professional Licensing Agency ("IPLA") which is the official agency charged with regulating all profes­ sional practices in Indiana 1Ulder IND. CODE§ 25-l-5-3 (2Gl0). 18. IND. CODE§. 25-22.5-2-7 (2010). 19. IND. CODE§ 25-1-94 (2010). 20. See Consumer Complaints, OFFICE OF THE IND. Arr'Y GENERAL, http://www.in. gov/attomeygeneral/2434.htm (last visited Mar. 11, 2012). · 21. Interview with Gabrielle Owens, Section Chief. Licensing Enforcement and Homeowner Protection Unit, Office of the Ind. Att'y Gen., in Indianapolis, Ind. (Feb. 28, 2011) (on file with author). 22. Id. 23. Id. 24. !d. 25. Id 26. ld. 27. Id; see also Stipulated Findings of Fact, Stipulated Conclusions of Law, Ultimate Conclusions of Law, and Order, In the Matter of the License of Michael A. P\Ulnett, 2009 700 INDIANA HEALTH LAW REVIEW [Vol. 9:2 hearings. 28 The hearing takes place before the Board, which is comprised of up to seven members appointed by the Govemor?9 Six Board members are phy-'­ sicians from all over Indiana, and at least one physician must be a doctor of osteopathy while the other five must be doctors of medicine. 30 The last member is a consumer member that can be anlt citizen of Indiana and serves as a representative of all Indiana consumers. 1 The Board is charged with regulating physician practice in Indiana and protecting consumers from fraud and abuse by licensed physicians. 32 The Board primarily consists of physicians because it is believed that they are in the best position to evalu­ ate medical practice. 33 As such, the Board promulgates rules for the prac­ tice of medicine, approves physicians for licensure, and disciplines physicians who violate Indiana law and the professional standards for the practice of medicine set by the Board. 34 The Board may discipline the phy­ sician's license by issuing a letter of public reprimand; by taking action on the physician's license, including revocation, suspension, or probation; by imposing fines up to $1,000 for each violation; or by a combination of the penalties listed. 3 In order to impose disciplinary action on a physician's license, the Board must find that the physician violated one of the thirteen provisions found under IC 25-1-9-4 ("Charging Statute").36 Such provisions prohibit physician-patient sexual relations, prescription drug diversion, the use of material deception to obtain a license to practice, failure to keep abreast of current professional theory or practice, and others.37 Moreover, the Board is authorized to promulgate additional rules,38 a violation of which would constitute varying violations of the charging statute. 39 These rules are tai­ lored to address "Standards of Professional Conduct and Competent Prac­ tice of Medicine" and are codified in the Indiana Administrative Code ("lAC") title 844, section 5.4° For example, IC 25-1-9-4(a)(4)(B) requires MLB 0032 (Ind. Med. Licensing Bd., Jun. 30, 2010). 28. IND. CODE§ 25-1-7-2 (2010). 29. IND. CODE§ 25-22.5-2-1 (2010). 30. IND. CODE§ 25-22.5-2-1(1) (2010); IND. CODE§ 25-22.5-2-1(2) (2010). 31. IND. CODE§ 25-22.5-2-1(3)(2010). 32. IND. CODE§ 25-22.5-2-7 {2010). 33. See generally IND. CODE § 25-22.5-2 (2010). 34. IND. CODE§ 25-22.5-2-7 (2010). 35. IND. CODE§ 25-1-9-9 (2010). 36. IND. CoDE§ 25-1-9-9 (2010). This statute recognizes two other specific instances in which the Board has authority impose discipline, which are Indiana Code section 25-1-9- 6.8, "Practitioner guidelines before prescribing stimulant medication for a child for treatment of certain disorders," and Indiana Code section 25-1-9-6.9, ''Failing to provide or providing false information to agency." However, these statutes are rarely invoked and the discipline in the scope of this Note is covered under the charging statute. 37. IND. CODE§ 25-1-9-4 (2010). 38. IND. CODE§ 25-22.5-2-7(2010). 39. See IND. CODE§ 25-1-9-4 (2010). 40. 8441ND. ADMIN. CODE 5 (2010). 2012] GUIDELINES FOR USING CONTROLLED SUBSTANCES FOR PAIN 701 physicians to "keep abreast of current professional theory and practice,'.41 and a violation of 844 lAC 5-3-3, which disallows treatment based on on­ line questionnaires,42 would invoke. the charging statute causing the AG complaint to charge the physician with a violation ofiC 25-1-9-4(a)(4)(B) to wit, 844 lAC 5-3-3, because the Board must prosecute for a violation of the charging statute.43 While some of the provisions appear to be criminal in nature, all provisions under the charging statute are licensing violations subject to discipline by the Board against the physician's license.