STATE OF FLORIDA Oar oi) DEPARTMENT OF HEALTH 6 Ory Adri By OF DEPARTMENT OF HEALTH, Hes Anal PETITIONER, Ol -Y 150 PL V. CASE NO. 2005-59975 ¢ JOSEPH DELUCA, D.O., | g RESPONDENT. ; ADMINISTRATIVE COMPLAINT COMES NOW Petitioner, Department ‘of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Osteopathic Medicine against Respondent, Joseph Deluca, D.O., and in support thereof alleges: . , 1. Petitioner is the state department charged with regulating the practice of osteopathic medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statues; and Chapter 459, Florida Statutes. 2. At all times material to this Complaint, Respondent was a licensed osteopathic physician within the State of Florida, having been issued license number OS 6712. JAPSU\Medical\Beth\AC\Deluca 2005-59975. Tldoc.docS0698 3. Respondent's address of record is 7522 Wiles Road, Suite 106B, Coral Springs, Florida 33067. 4, Between February 2004 and June 2004 Respondent was . employed by The Doctor's Office. | . Facts Related to Patient A.O. 5. On or about February 26, 2004, Respondent prescribed and mailed Patient A.O. one hundred (100) vials of Buprenorphine. 6. Buprenorphine is an opioid drug with partial agonist and antagonist actions primarily used for the treatment of opioid addiction. It is a Schedule III controlled substance pursuant to Chapter 893, Florida Statutes. A substance in Schedule III may lead to moderate or low physical dependence or high psychological dependence, but has a currently accepted medical use in treatment in the United States. 7. On or about March 15, 2004, Respondent prescribed and mailed Patient A.O. one hundred (100) vials of Buprenorphine. 8, On -or-about: April -5,-2004,-Respondent prescribed and. mailed Patient A.O. one hundred (100) vials of Buprenorphine. 9. Onor about April 21, 2004, Respondent prescribed and mailed . Patient A.O. one hundred (100) vials of Buprenorphine. JAPSU\Medical\Beth\AC\Deluca 2005-59975. Idoc.docS0698 2 10. On or about May 6, 2004, Respondent prescribed and mailed - Patient A.O. one hundred (100) vials of Buprenorphine. 11. Onor about May 24, 2004, Respondent prescribed and mailed Patient A.O. one hundred (100) vials of Buprenorphine. 12. On or about June 8, 2004, Respondent prescribed and mailed Patient A.O. one hundred (100) vials of Buprenorphine. 13. During February 2004 through June 2004, Respondent never had a face to face meeting with Patient A.O. 44. Prior to and while prescribing Buprenorphine to Patient AO. on or about February 26, 2004, through June 8, 2004, Respondent failed to perform or document an adequate evaluation of Patient A.O., including an adequate medical history and adequate physical examination, to justify . prescribing Buprenorphine; Respondent failed to assess and document assessing the patient regarding whether the medication was working to either alleviate his pain, to decrease his pain, or to decrease his opioid dependence; Respondent failed to refer the patient for additional consultations or additional diagnostic testing; Respondent failed to document discussing the risks and benefits of taking Buprenorphine with IAPSU\Medical\Beth\AC\Deluen 2005-5997 5.11ldoc.docS0698 1 3 Patient A.O.; Respondent failed to prepare and document an adequate treatment plan for Patient A.O.; or Respondent failed to keep adequate medical records of his treatment of Patient A.O. Facts Related to Patient J.E. 15. On or about February 13, 2004, Respondent began seeing Patient J.E. and Respondent prescribed 50 cc of Buprenorphine to Patient 1E. | 16. On or about February 27, 2004, Respondent prescribed 50 cc of Buprenorphine to Patient J.E. 17. On or about March 30, 2004, Respondent prescribed 50 cc of Buprenorphine to Patient 1. 18. On or about April 15, 2004, Respondent prescribed 50 cc of Buprenorphine to Patient J.E. ) -19. On or About May 10, 2004, Respondent prescribed 50 cc of ‘Buprenorphine to Patient J.E. 20. On or About June 3, 2004, Respondent prescribed 50 cc of Buprenorphine to Patient J.E. 21. Prior to and while prescribing Buprenorphine to Patient J.E. on or about February 13, 2004, through June 3, 2004, Respondent failed to JAPSU\Medical\Beth\AC\Deluca 2005-59975. IMdoc.docs0698 4 i . perform or document an adequate evaluation of Patient J.E., including an - adequate medical history and adequate physical examination, to justify prescribing Buprenorphine; Respondent failed to assess and document assessing the patient regarding whether the medication was working to either alleviate the pain, to. decrease the pain, or to decrease opioid ’ dependence; Respondent failed ‘to _refer the. patient for additional “consultations or additional diagnostic testing; Respondent failed . to document discussing the risks and benefits of taking Buprenorphine with Patient J.E.; Respondent failed to prepare and document an adequate treatment plan for Patient J.E.; or Respondent failed to keep adequate medical records of his treatment of Patient J.E. Facts Related to Patient FH. 22. On or about February 10, 2004, Respondent began seeing Patient F.H. and Respondent prescribed seventy-five (75) vials of Buprenorphine; twenty (20) tablets of Lorcet; and thirty (30) tablets of Soma, | 23. Lorcet is a legend drug as defined by Section 465.003(8), Florida Statutes, and it contains hydrocodone bitartrate and . acetaminophen, which, when mixed together, is a Schedule ITT controlled JAPSU\Medical\Beth\AC\Deluca 2005-59975. Midoc.docS0698 5 substance. Lorcet is indicated for the relief of moderate to moderately severe pain. Lorcet has a potential for abuse, and the abuse of Lorcet can lead to moderate or low physical dependence or high psychological dependence. , 24. Soma contains carisoprodol, which is a Schedule IV controlled substance under Chapter 893, Florida Statutes. It is a muscle relaxant used as an adjunct to rest, physical therapy, and other measures for the . relief of discomfort associated with acute, painful musculoskeletal conditions. The effects of carisoprodol and other central nervous system depressants may be additive. A substance in Schedule IV has a low ‘potential for abuse, and a currently accepted medical use in treatment. Abuse of this substance may lead to limited physical or psychological dependence. 25. On or about February 16, 2004, Respondent prescribed Patient F.H. ninety (90) vials of Buprenorphine; fifty (50) tablets of Lorcet; and sixty (60) tablets of Soma. 26. On or about February 23, 2004, Respondent prescribed Patient F.H. eighty. (80) vials of Buprenorphine, thirty (30) tablets of Lorcet; and forty (40) tablets of Soma. JAPSU\Medical\Beth\AC\Deluca 2005-59975. Mdoc.docS0698 . 6 27. On or about March, 1, 2004, Respondent prescribed Patient F.H. unidentifiable amount of Buprenorphine; ten (10) tablets of Lorcet; and twenty (20) tablets of Soma. 28. Onor about March 4, 2004, Respondent prescribed Patient F.H. seventy-five (75) vials of Buprenorphine; forty (40) tablets of Lorcet; and thirty.(30) tablets of Soma. , | 29, Onor about March 8, 2004, Respondent prescribed Patient F.H. eighty-five (85) vials of Buprenorphine; thirty (30) tablets of Lorcet; and thirty (30) tablets of Soma. | - 30. On or about March 15, 2004, Respondent prescribed Patient F.H. eighty-five (85) vials of Buprenorphine; thirty (30) tablets of Lorcet; cand thirty (30) tablets of Soma. | . . 31. On or about March 18, 2004, Respondent prescribed Patient F.H. twenty (20) vials of Buprenorphine; twenty (20) tablets of Lorcet; and . twenty (20) tablets of Soma. 32. On or about April 21, 2004, Respondent prescribed Patient F.H. one hundred (100) vials of Buprenorphine; sixty (60) tablets of Lorcet; and sixty (60) tablets of Soma. JAPSU\Medical\Beth\AC\Deluca 2005-59975. HIdoc.doc50698 33. On or about April 29, 2004, Respondent prescribed Patient F.H. one hundred (100) vials of Buprenorphine; forty (40) tablets of Lorcet; and. forty (40) tablets of Soma. . 34, On or about May 4, 2004, the Respondent prescribed Patient F.H. ten (10) tablets of Percocet; sixty (60) tablets of Lorcet; and sixty (60) tablets of Soma. | oe _35. Percocet contains ‘oxycodone hydrochloride, a semi-synthetic — narcotic analgesic, which is a Schedule II controlled substance under Chapter 893,.Florida Statutes. Percocet is indicated for relief of moderate to moderately severe pain. It has a high potential for abuse and has a currently accepted, but limited medical use in treatment in the United States, and abuse of the substance may lead to severe: physical and psychological dependence. . 36. Onor about May 10, 2004, Respondent prescribed Patient F.H. hundred (100) vials of Buprenorphine; forty (40) tablets of Lorcet; and forty (40).tablets of Soma. . | 37. Onor about May 17, 2004, Respondent prescribed Patient F.H. one hundred (100) vials of Buprenorphine; sixty (60) tablets of Lorcet; and sixty (60) tablets of Soma. JAPSU\Medical\Beth\AC\Deluca 2005-59975. Idac.doc50698 , g 38. On or about May 24, 2004, the Respondent prescribed Patient F.H. ten (10) tablets of Percocet; forty (40) tablets of Lorcet; and forty (40) tablets of Soma. 39. -On or about May 27, 2004, the Respondent prescribed Patient F.H. forty (40) tablets of Lorcet and forty (40) tablets of Soma. | 40. On or about June 3, 2004, the Respondent prescribed Patient F.H. fifteen (15) tablets of Percocet; forty (40) tablets of Lorcet; and forty (40) tablets of Soma. ) . 41. On or about June 8, 2004, the Respondent prescribed Patient F.H. thirty (30) tablets of Percocet; sixty (60) tablets of Lorcet; and sixty (60) tablets of Soma. 42. Prior to and while prescribing Buprenorphine, Percocet, Lorcet, and Soma to Patient F.H. on or about February 10, 2004, through June 8, 2004, Respondent failed to perform or document an adequate evaluation of Patient F.H., including an adequate medical history and adequate physical examination, to justify prescribing Buprenorphine, Percocet, Lorcet, or Soma; Respondent failed to assess and document assessing the patient regarding whether the medications were working to either alleviate the pain, to decrease the pain, or to decrease opioid dependence; JAPSU\Medical\Beth\AC\Deluea 2005-59975, [doc.doc50698 . 9 Respondent failed to refer the patient for additional consultations or additional diagnostic testing; Respondent failed to document discussing the - risks and benefits of taking Buprenorphine, Percocet, Lorcet, or Soma with Patient F.H.; Respondent failed to prepare and document an adequate ‘treatment plan for Patient F.H.; or Respondent failed to keep adequate medical records-of his treatment of Patient F.H. Facts Related to Patient E.H. . 43. on or about February 11, 2004, Respondent began. seeing Patient E.H. and Respondent prescribed fifty (50) vials of Buprenorphine and three (3) tablets of Xanax to Patient E.H. | 44. Xanax, which contains alprazolam, is a Schedule IV controlled substance under Chapter 893, Florida Statutes. A substance in Schedule IV has a low potential for abuse, and a currently accepted medical use in treatment. Abuse of this substance may lead to limited physical or. psychological dependence. 45. On or about February 12, 2004, Respondent prescribed Patient E.H. fifteen (15) tablets of Xanax. 46. On or about February 19, 2004, Respondent prescribed Patient E.H. ten (10) vials of Buprenorphine and fifteen (15) tablets of Xanax. JAPSU\Medical\Beth\AC\Deluca 2005-59975. Ildoc.dacs0698 10 47. On or about February 23, 2004, Respondent prescribed Patient : EH. twenty (20) vials of Buprenorphine and according to the medical records Respondent prescribed.an undisclosed amount of Klonopin. 48. Klonopin _ is . benzodiazephine.. Benzodiazepines are compounds with anti-anxiety, hypnotic, anticonvulsant, and skeletal muscle relaxant properties. — Such drugs are listed as Schedule IV controlled substance under Chapter 893, Florida Statutes. A substance in Schedule IV has a low potential for abuse, and a currently accepted medical use in treatment. Abuse of this substance may lead to limited physical or psychological dependence. 49. On or about February 26, 2004, Respondent prescribed Patient E.H. fifteen (15) tablets of Xanax. | | 50. On or about March 2, 2004, Respondent prescribed Patient E.H. twenty (20) vials of Buprenorphine. 5i. On or about March 5, 2004, Respondent prescribed Patient E.H. fifty (50) vials of Buprenorphine and thirty (30) tablets of Xanax. 52. On or about March 9, 2004, Respondent prescribed Patient E.H. fifty (50) vials of Buprenorphine and thirty (30) tablets of Xanax. JAPSU\Medical\Beth\AC\Deluca 2005-59975. Hldoc.dac50698 53. On.or about March 12, 2004, Respondent prescribed Patient E.H. five (5) vials of Buprenorphine. | . 54, On or about March 16, 2004, Respondent prescribed Patient E.H. approximately fifty (50) vials of Buprenorphine and approximately ‘thirty (30) tablets of Xanax. | 55. On or about March 29, 2004, Respondent prescribed Patient E.H. approximately fifty (50) vials of Buprenorphine and approximately thirty (30) tablets of Xanax. 56. Onor about April 6, 2004, Respondent prescribed Patient E.H. fifty (50) vials of Buprenorphine and thirty (30) tablets of Xanax. — 57. On or about April 13, 2004, Respondent prescribed Patient E.H. seventy-five (75) vials of Buprenorphine and forty-five (45) tablets, of Xanax. 58. On or about April 26, 2004, Respondent prescribed Patient E.H.. forty-five (45) tablets of Xanax. . . 59. On or about May 5, 2004, Respondent prescribed Patient E.H. seventy-five (75) vials of Buprenorphine. | 60. On or about May 14, 2004, Respondent prescribed Patient E.H. fifty (50) vials of Buprenorphine and forty-five (45) tablets of Xanax. JAPSU\Medical\Beth\AC\Deiues 2005-59975, Idoc.doc50698 ‘ ; 12 61. Onor about May 24, 2004, Respondent prescribed Patient E.H. one hundred fifty (150) vials of Buprenorphine and ninety (90) tablets of Xanax. a 62. On or about June 11, 2004, Respondent prescribed Patient E.H. two hundred forty (240) vials of Buprenorphine and one hundred twenty (120) tablets of Xanax. | , 63. Prior to and while prescribing Buprenorphine, Xanax, and Klonopin to Patient E.H. on or about February 11, 2004, through June 11, | 2004, Respondent failed to perform or document an adequate evaluation of Patient E.H., including an adequate medical history and adequate physical examination, to justify prescribing Buprenorphine, Xanax, and Klonopin; Respondent failed to assess and document assessing the patient regarding whether the medications were working to either alleviate the pain, to decrease the pain, or to decrease opioid dependence; Respondent failed to refer the patient for additional consultations or additional diagnostic testing; Respondent failed to document discussing the risks and benefits of taking Buprenorphine, Xanax, and Klonopin with Patient E.H.; Respondent failed to prepare and document an adequate treatment plan JAPSU\Medical\Beth\AC\Deluca 2005-59975.Idoc.doc50698 : 13 for Patient E.H.; or Respondent failed to keep adequate medical records of his treatment of Patient E.H. Facts Related to Patient K.H. 64. On or about February 16, 2004, Respondent began seeing Patient K.H. and Respondent prescribed one hundred (100) vials of Buprenorphine and fifteen (15) tablets of Xanax to Patient K.H. 65. On or about February 23, 2004, Respondent prescribed Patient K.H. two hundred (200) vials of Buprenorphine and thirty (30) tablets of Xanax. 66. On or about March 29, 2004, Respondent prescribed Patient K.H. three hundred (300) vials of Buprenorphine. 67. On or about April 26, 2004 Respondent prescribed Patient K.H. one hundred (100) vials of Buprenorphine and thirty (30) tablets of Xanax. | 68. Prior to and while prescribing Buprenorphine and Xanax to. Patient K.H. on or about February 16, 2004, through April 8, 2004, Respondent failed to perform or document an adequate evaluation of Patient K.H., including an adequate medical history and adequate physical examination, to justify prescribing Buprenorphine and Xanax; Respondent failed to assess and document assessing the patient regarding whether the JAPSU\Medical\Beth\AC\Deluca 2005-59975.Ilidac.docS0698 14 : j i! medications were working to either alleviate the pain, to decrease the pain, or to decrease opioid dependence; Respondent failed to refer the patient for additional consultations or additional diagnostic testing; Respondent failed to document discussing the risks and benefits of taking | Buprenorphine and Xanax with Patient K.H.; Respondent failed to prepare and document an adequate treatment plan for Patient K.H.; or Respondent failed to keep adequate medical records of his treatment of Patient K.H. . Facts Related to Patient A.P. 69. On or about February 9, 2004, Respondent began seeing Patient A.P. and Respondent prescribed five () vials of Buprenorphine; ~ and six (6) tablets of Xanax to Patient A.P, - 70. . On or about February 11, 2004, Respondent prescribed Patient AP. six (6) vials of Buprenorphine and six (6) tablets of Xanax. 71. On or about February 12, 2004, Respondent prescribed Patient A.P. approximately six (6) vials of Buprenorphine and approximately six (6) tablets of Xanax. 72. Onor about February 13, 2004, Respondent prescribed Patient A.P. twenty-five (25) vials of Buprenorphine and six (6) tablets of Xanax. JAPSU\Medical\Beth\AC\Deluca 2005-59975. Mdoc,doc50698 : 15 81. On or about March 19, 2004, Respondent prescribed Patient AP, five. (5) vials of Buprenorphine. 82. On or about March 22, 2004, Respondent prescribed Patient A.P. forty (40) vials of Buprenorphine and thirty-two (32) tablets of Xanax. 83. On or about March 29, 2004, Respondent prescribed Patient A.P. forty (40) vials of Buprenorphine and thirty (30) tablets of Xanax. — 84, On or about April 2, 2004, Respondent prescribed Patient A.P. forty-five (45) vials of Buprenorphine. | | | 85. On or about April 5, 2004, Respondent prescribed Patient AP. thirty-four (34) vials of Buprenorphine. 86. On or about April 12, 2004, Respondent prescribed Patient A.P. one hundred (100) vials of Buprenorphine and fifty (50) tablets of Xanax. 87. On or about April 19, 2004, Respondent prescribed Patient A.P. one hundred (100) vials of Buprenorphine. 88. On or about May 3, 2004, Respondent prescribed Patient A.P. fifty (50) tablets of Xanax. , 89. On or about May 5, 2004, Respondent prescribed Patient A.P. eight (8) tablets of vials and thirty (30) tablets of Lorcet. JAPSU\Medical\Beth\AC\Deluca 2005-59975.Idoe.doc50698 17 90. On or about May 18, 2004, Patient A.P. requested to be taken off Buprenorphine and the Respondent began to decrease the amount of Buprenorphine taken by A.P. - . | ot. On or about May 28, 2004, Respondent prescribed Patient A.P. one hundred (100) tablets of Xanax. . 92. On or about June 3, 2004, Respondent prescribed Patient A.P. three ‘hundred (300) vials of Buprenorphine; one hundred twenty (120) tablets of Xanax; and fifty (50) tablets of Lorcet. 93. Prior to and while prescribing Buprenorphine, Xanax, and Lorcet to Patient A.P. on or about February 9, 2004, through June 3, 2004, Respondent failed to perform or document an adequate evaluation of Patient A.P., including an adequate medical history and adequate physical examination, to justify prescribing Buprenorphine, Xanax and Lorcet; Respondent failed to assess and document assessing the patient regarding whether the medication was working to either alleviate the pain, to decrease the pain, or to decrease opioid dependence; Respondent failed to refer the patient for additional consultations or additional diagnostic testing; Respondent failed to document discussing the risks and benefits of taking Buprenorphine, Xanax and Lorcet with Patient A.P.; Respondent JAPSU\Medical\Beth\AC\Deluca 2005-59975.Mdoc.dacs0698 18 failed to prepare and document an adequate treatment plan for Patient A.P.; or Respondent failed to keep adequate medical records of his treatment of Patient A.P. | Facts Related to Patient M.O. 94. On or about February 12, 2004, Respondent began seeing Patient M.Q. and Respondent prescribed twenty (20) vials of Buprenorphine to Patient M.Q. 95. On or about February 13, 2004, Respondent prescribed Patient M.Q. fifteen (15) vials of Buprenorphine along with a prescription for Lexapro and Strattera. , 96. Lexapro contains Escitalopram which is used to treat depression and generalized anxiety disorder (GAD). This medication works by restoring the balance of certain chemicals in the brain to improve mood and feelings of well-being. It is known as a selective serotonin reuptake inhibitor. (SSRI). 97. Strettera contains Atomoxetine which is used to treat attention- deficit hyperactivity disorder (ADHD). It works by helping to restore the balance of certain natural chemicals in the brain (neurotransmitters). It AAPSU\Medical\Beth\AC\Deluca 2005-59975 Mldac.docs0698 19 may help to increase the ability to pay attention, concentrate, stay focused, and stop fidgeting. 98. On or about February 16, 2004, Respondent prescribed Patient M.O. fifty (50) vials of Buprenorphine. 99, Onor about February 20, 2004, Respondent prescribed Patient 7 M.Q. one hundred (100) vials of Buprenorphine. . | 100.On or about March 1, 2004, Respondent prescribed Patient M.Q. one hundred (100) vials of Buprenorphine. | 101..0n or about March 10, 2004, Respondent prescribed Patient M.Q. one hundred (100) vials of Buprenorphine. | 102. On or about March 19, 2004, Respondent prescribed Patient M.Q. one hundred (100) vials of Buprenorphine. . . 103. On or about March 22, 2004, Respondent prescribed Patient . M.Q. two hundred (200) vials of Buprenorphine. 104. On or about April 9, 2004, Respondent prescribed Patient M.Q. one hundred (100) vials of Buprenorphine. 105. On or about April 14, 2004, Respondent prescribed Patient M.Q. thirty (30) tablets of amoxicillin. JAPSU\Medical\Beth\AC\Deluca 2005-39975.Hidor.dac50698 20 106. Amoxic ilin is a penicillin-type antibiotic used to treat a wide variety of bacterial infections. Tt works by stopping the growth of bacteria. 107. On or about April 23, 2004, Respondent prescribed Patient M.Q. forty (40) vials of Buprenorphine. | 108. On o r about April 30, 2004, Respondent prescribed Patient M.Q. thirty (30) vials of Buprenorphine. 109. On or about May 5, 2004, Respondent prescribed Patient M. Q. one ‘hundred (100) vials of Buprenorphine. 110. On or about May 13, 2004, Respondent prescribed Patient M.Q. one hundred (100) vials. of Buprenorphine. 111. On: or about May 24, 2004, Respondent prescribed f Patient M, Q. one hundred (100) vials of Buprenorphine. 112. On or about June 5, 2004, Respondent prescribed Patient M.Q. one hundred (100) vials of Buprenorphine. . 113. Prior to and while prescribing Buprenorphine, Lexapro, Strattera, and Amoxicillin to Patient M.Q. on or about February 12 through June 5, 2004, Respondent failed to perform or document an adequate evaluation of Patient M.Q., including an adequate medical history and adequate physical examination, to justify prescribing Buprenorphine, JAPSU\Medical\Beth\AC\Deluca 2005-59975.Mdac.doc50698 1 Lexapro, Strattera, and Amoxicillin; Respondent failed to assess and document assessing the patient regarding whether the Buprenorphine was working to either alleviate the pain, to decrease the pain, or to decrease opioid dependence; Respondent failed to refer the patient for additional consultations or additional diagnostic testing; Respondent failed to document discussing the risks and benefits of taking Buprenorphine, Lexapro, Strattera, and Amoxicillin with Patient M.Q.;.Respondent failed to prepare and document an adequate treatment plan for Patient M.Q.; or . Respondent failed to keep adequate medical records of his treatment of _ Patient M.Q. | Facts Related Patient K.H. 114. On. or about February 12, 2004, Respondent began seeing Patient K.H. and Respondent prescribed sixty (60) vials of Buprenorphine | to Patient K.H. | 115. On or about March 3, 2004, Re spondent prescribed Patient K.H. sixty (60) vials of Buprenorphine. . | | 116. On or about March 16, 2004, Respondent prescribed Patient ‘K.H. sixty (60) vials of Buprenorphine and thirty (30) tablets of amoxicillin. J:APSU\Medieal\Beth\AC\Deluca 2005-59975. Mdoc.dac50698 124. On or about June 8, 2004, Respondent prescribed Patient K.H. fifty (50) vials of Buprenorphine; ten (10) tablets of Xanx; and sixty (60) tablets of Percocet. . | 125. Prior to and while prescribing Buprenorphine, Lorcet, Perocet, and Amoxicillin to Patient K.H. on or about February 12, 2004 through June 8, 2004, Respondent failed to perform or document an adequate evaluation of Patient K.H. including an adequate medical history and adequate physical examination, to justify prescribing Buprenorphine, Lorcet, Perocet, or Amoxicillin; Respondent failed to assess and document assessing the patient regarding whether the medications were working to either alleviate the pain, to decrease the pain, or to decrease opioid dependence; Respondent failed to refer the patient for additional consultations or additional diagnostic testing; Respondent failed to document discussing the ‘risks and benefits of taking Buprenorphine, Lorcet, Perocet, and Amoxicillin with Patient K.H.; Respondent failed to prepare and document an adequate | treatment plan for Patient K.H.; or Respondent failed to keep adequate ‘medical records of his treatment of Patient K.H. AAPSU\Maedical\Beth\AC\Deluca 2005-39975.1Idoc.dacS0698 COUNT ONE 126. Petitioner realleges and incorporates paragraphs one (1) through one hundred twenty-five (125) as if fully set forth herein. 127. Section 459. 015(1)(0), Florida. Statutes (2004), provides that failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed osteopathic physician or the osteopathic physician extender or supervising osteopathic physician _ by name and professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations, constitutes grounds for discipline by the Board of Osteopathic Medicine: 128. Rule 64B15-15.004, Florida Administrative Code (“F.A.C."), provides in relevant part, 64B15-15,004 Written Records; Minimum Content; Retention. (1) For the purpose of implementing the provisions of subsection 459.015(1)(0), Florida Statutes, osteopathic physicians shall maintain written legible records on each patient. Such written records shall contain, at a minimum, the following information about the patient: JAPSU\Medical\Beth\AC\Deluca 2005-59975. Mldac.doc50698 25 (a) Patient histories; (b) Examination results; (c) Test results; (d) Records of drugs prescribed, dispensed or administered; (e) Reports of consultations; and (f) Reports of hospitalizations. 129. Respondent failed to keep legible medical records that justified the course of treatment of Patients A.O., J.E., F-H., E.H., KH., AP., M.Q., . or K.H. in one or more of the following ways: a). by failing to record or inadequately recording physical examinations of Patients A.O,, J.E., F.H., E.H., KH,, AP., M.Q., or K.H.; b) _ by failing to document a complete and proper medical history for Patients A.O., J.E., F.H., E.H., K.H., A.P., M.Q., or K.H.; -c) | by failing to document a treatment plan with objectives for Patients A.O., J.E., F.H., E.H., K.H., A.P., M.Q., or KH.; d) by failing to adequately document justifications for prescribing Buprenophrine, Percocet, Lorcet, Soma, Amoxcillian, Xanax, Klonopin, Lexapro, or Strettera to Patients A.O., J.E., F.H., E.H., K.H., A.P., M.Q., or K.H.;. e) by failing to document discussing the risks and benefits of taking Buprenophrine, Percocet, Lorcet, Soma, Amoxcillian, Xanax, J ‘\PSU\Medical\Beth\AC\Deluca 2005-59975. Idoc.docS0698 26 Klonopin, Lexapro, or Strettera with Patients A.O., J.E., F.H., E.H., KH., A.P., M.Q., and K.H.; f) by failing to adequately document assessing Patients A.O., J.E., F.H., E.H., K.H., AP., M.Q., or KH. regarding whether the medications were working to either alleviate their pain, to decrease their pain, or to decrease opioid dependence; or g) by failing to document referring the patients for consultations or additional diagnostic testing. 130. Based on the foregoing, Respondent has violated ‘Section 459.015(1)(0), Florida Statutes (2004), and Rule 64B15-15.004, F.A.C., by failing to keep legible medical records that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations. COUNT TWO 131. Petitioner -realleges and incorporates paragraphs one (1) through one hundred twenty-five (125) as if fully set forth herein. JAPSU\Medical\Beth\AC\Deluca 2005-59975. TMdoc.docS0698 27 132. Section 459.015(1)(t), Florida Statutes (2004), provides that prescribing, dispensing, administering, supplying, selling, giving, mixing, or otherwise preparing a legend drug, including all controlled substances, .’ other than in the course of the osteopathic physician’s professional practice is grounds for disciplinary ‘action by the Board of Osteopathic Medicine. For the purposes of this paragraph, it shall be legally presumed that prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and not in. the course of the osteopathic physician's professional practice, without regard to his or her intent. 133. Respondent prescribed Patients A.O., J.E., F.H., E.H., K.H., AP., M.Q., or KH. Bupren ophrine, Percocet, Lorcet, Soma, Xanax, or Klonopin, all controlled substances, inappropriately or in excessive or inappropriate quantities, in that Respondent prescribed controlled substances without medical justification, in quantities which endangered the patient’s health, were’ not in the best interest of the patient or in a manner not in the course of the physician’s professional practice. IAPSU\Medical\Beth\AC\Deluca 2005-59975. Ildoc.dac50698 ‘ ot 28 134. Based on the foregoing, Respondent has violated Section 459.015(1)(t) Florida Statutes (2004), by prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any . controlled substance, other than in the ‘course of the osteopathic physician's professional practice. For the purposes of this paragraph, it shall be legally presumed that prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient end not in the course of the osteopathic physician’s professional practice, without regard to his or her intent. | COUNT THREE 135. Petiti oner -realleges and incorporates paragraphs one (1) through one hundred twenty-five (125) as if fully set forth herein. 136. Secti on 459.015(1)(X), Florida Statutes (2004), provides that gross. or repeated. malpractice. or. the. failure. to. practice. osteopathic medicine with that level of care, skill, and treatment which is recognized by . a reasonable prudent similar osteopathic physician as being accepted under : JAPSU\Medical\Beth\AC\Deluca 2005-59975.IMdoc.docS0698 -and treatment plan. Accordingly, these guidelines have been developed to clarify the Board's position on pain control, specifically as related to the use of controlled substances, to alleviate physician uncertainty and to encourage better pain management. (c) The Board recognizes that controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins. Osteopathic physicians are referred to the U.S. Agency for Health Care Policy and. Research Clinical Practice Guidelines for a sound. approach to the management of acute and cancer-related pain. The medical management of pain including intractable pain should be based on current knowledge and research and includes the use of both pharmacologic and non- pharmacologic modalities. Pain should be assessed and treated promptly, and the quantity and frequency of doses should be adjusted according to the intensity and duration of the pain. Osteopathic physicians should recognize that tolerance and physical dependence are normal ' consequences of sustained use of opioid analgesics and are not synonymous with addiction. .(d) The Board of Osteopathic Medicine is obligated under the laws of the _ State of Florida to protect the public ‘health and safety. The Board recognizes that inappropriate prescribing of controlled substances, including opioid analgesics, may lead to drug diversion and abuse by | individuals who seek them for other than legitimate medical use. Osteopathic physicians should be diligent in preventing the diversion of drugs for illegitimate purposes. (e) The Board will consider prescribing, ordering, administering, or dispensing controlled substances for pain to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of pain or if based on sound clinical grounds. All such prescribing must be based on clear documentation of unrelieved Pain and in compliance with applicable state or federal law. - (f) Each case of prescribing for pain will be evaluated on an individual basis. The Board will not take disciplinary action against an osteopathic physician for failing to adhere strictly to the provisions of these guidelines, if good cause is shown for such deviation. The osteopathic physician's conduct will be evaluated to a great extent by the treatment outcome, taking into account whether the drug used is medically and/or pharmacologically recognized to be appropriate for the diagnosis, the JAPSU\Medical\Beth\AC\Deluca 2005-59975 Mldoc.docS0698 i { patient's individual need including any improvement in functioning, and recognizing that some types of pain cannot be completely relieved. (g) The Board will judge the validity of prescribing based on the osteopathic physician's treatment of the patient and on available documentation, rather than.on the quantity and chronicity of prescribing. The goal is to control the patient's pain for its duration while effectively addressing other aspects of the patient's functioning, including physical, psychological, social, and work-related factors. The following guidelines are not intended to define complete or best practice, but rather to communicate what the Board considers to be within the boundaries of professional practice. , * * * (3) Guidelines. The Board has adopted the following guidelines when evaluating the use of controlled substances for pain control: (a) Evaluation of the Patient. A complete medical history and physical examination must be conducted and documented in the medical. record. . The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance. (b) Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the osteopathic physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation _program may be necessary depending on the etiology of the pain and the extent to, which the pain is associated with the physical and psychosocial impairment. (c) Informed Consent and Agreement for Treatment. The osteopathic physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is incompetent. The patient should receive prescriptions from one osteopathic physician and one pharmacy where possible. If the patient is determined to be at high risk for JAPSU\Medical\Beth\AC\Deluca 2005-59975,Uldac.docS0698 33 medication abuse or have a history of substance abuse, the osteopathic . physician may employ the use of a written agreement between physician and patient outlining patient responsibilities, including, but not limited to: 1. urine/serum medication levels screening when requested; 2. number and frequency of all prescription refills;.and 3.reasons for which drug therapy may be discontinued (i.e., violation of agreement). (d) Periodic Review. At reasonable intervals based on the individual circumstances of the patient, the osteopathic physician should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the osteopathic physician's evaluation of progress toward stated treatment ‘objectives such as improvement in patient's pain intensity and improved physical and/or psychosocial function, i.e., ability to work, need of health care resources, activities of daily living, and quality of social life. If treatment goals are not being achieved, despite medication adjustments, the osteopathic physician should reevaluate the appropriateness of continued treatment. The osteopathic physician should monitor patient compliance in medication usage and related treatment plans. ~(e) Consultation. The osteopathic physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to _ achieve treatment objectives. Special attention should be given to those ‘pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation, and consultation with or referral to an expert in the management of such patients. (f) Medical Records. The osteopathic physician is required to keep accurate and complete records to include, but not be limited to: . the medical history and physical examination; . diagnostic, therapeutic, and laboratory results; . evaluations and consultations; . treatment objectives; . discussion of risks and benefits; . treatments; . medications (including date, type, dosage, and quantity prescribed); . instructions and agreements; and , ON DUABRWNE JAPSU\Medical\Beth\A C\Deluca 2005-59975. Mdoc.docS0698 34 9. periodic reviews. , Records must remain current and be maintained in an accessible manner and readily available for review. (g) Compliance with Controlled Substances Laws and Regulations. To prescribe, dispense, or administer controlled substances, the osteopathic physician must be licensed in the state and comply with applicable federal and state regulations. Osteopathic physicians are referred to the Physicians Manual: An Informational Outline of the Controlled Substances Act of 1970, ~ published by the U.S. Drug Enforcement Agency, for specific rules governing controlled substances as well as applicable state regulations. 139. By failing to meet the standards of practice established in Rule 64B15-14.005, FA.C., Respondent has failed to practice osteopathic medicine with that level: of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances. 140. Based on_ the. foregoing, Respondent has ‘Violated Section 459.015(1)(x), Florida Statutes (2004), by failing to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances. Additionally, Respondent has violated the standards of practice established by the Board of Osteopathic Medicine in Rules 64B15-14.005 and thereby he has violated Section JAPSU\Medical\Beth\AC\Deluca 2005-59975. ldoc.docs0698 35 459.015(1)(x), Florida Statutes (2004), in Respondent’s treatment of Patients A.O., J.E., F.H., E.H., K.H., A.P., M.Q., or KH. WHEREFORE, Petitioner respectfully requests that the Board of Osteopathic Medicine enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, . - refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. ve . SIGNED this_2/? _ day of Movessber , 2006. #M,D., M.S.P.H., Ph.D nt of Health . Blake Hunter Assistant General Counsel OH Prosecution Services Unit CLERK: AQ * 9; 4052 Bald Cypress Way, Bin C-65 - DATE , Tallahassee, FL 32399-3265 Florida Bar No. 0570788 (850) 245-4640, ext. 8114- DEPARTMENT OF HEALTH DEPUTY CLERK , (850) 245-4682 FAX PCP: Kon finer ad! Ardadv 0-0 PCP Members: Wow. i 7,008 JAPSU\Medical\Beth\AC\Deluca 2005-59975. Uldoc.dacS0698 36 NOTICE OF RIGHTS | Respondent. has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested. NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this. matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a _ disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed . JAPSU\Medical\Beth\AC\Deluca 2005-59975, Idoc.doc50698 : 37 t .

Docket for Case No: 07-004750PL