STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, v. Case No: 2011-02286 DONALD B. BLETZ, M.D. RESPONDENT. ADMINISTRATIVE COMPLAINT The Petitioner, Department of Health, by and through the undersigned counsel, files this Administrative Complaint (Compliant) before the Board of Medicine against the Respondent, Donald B, Bletz, M.D., and in support alleges: 1. The Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes, Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. 9, Atall times material to this Complaint, the Respondent was a licensed physician within the state of Florida, having been issued license number ME 67306 3. The Respondent’s address of record is 2400 Spanish River Road, Boca Raton, Florida 33432. 4. At all times material to this Complaint, the Respondent was board certified in internal medicine. Filed January 12, 2012 2:19 PM Division of Administrative Hearings 5. Atall times material to this Complaint, the Respondent was practicing at Total Medical Express of Boca Raton (clinic), also known as Palm Beach Pain and Rejuvenation, which was a registered pain management clinic located at 6201 North Federal Highway, Boca Raton, FL 33487. 6. On or about January 20, 2011, the Department conducted a dispensing practitioner inspection of the clinic. 7, The inspection revealed that the Respondent was prescribing Flexeril, ibuprofen, oxycodone, Roxicodone, Valium and Xanax to his patients. 8. Flexeril is the brand name for cyclobenzaprine hydrochloride. Flexeril is prescribed as an adjunct to rest and physical therapy for relief of muscle spasms associated with acute, painful musculoskeletal conditions. Flexeril is a not scheduled drug. 9. Ibuprofen is a nonsteriodal anti-inflammatory drug used as an analgesic. It is similar in action to aspirin but less apt to cause gastrointestinal side effects. Ibuprofen is not a scheduled drug. 10. Oxycodone is an opioid commonly prescribed to treat pain. According to Section 893.03(2), Florida Statutes (2010-2011), oxycodone is a Schedule I controlted substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United Page 2. of 31 States, Abuse of oxycodone may lead to severe psychological or physical dependence. 11. Opiate, or opioid, drugs have similar actions as the drug opium and are typically prescribed to treat pain. Opioid drugs are synthetically manufactured, while opiate drugs are naturally occurring, but the terms opioid and opiate are often used interchangeably. Opioid drugs are addictive and subject to abuse. 12. Roxicodone is the brand name for an immediate release formulation of oxycodone. Roxicodone is typically used to treat break through pain. 13. Valium is the brand name for diazepam and is prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes (2010-2011), diazepam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use in treatment in the United States. Abuse of diazepam may lead to limited physical or psychological dependence relative to the substances in Schedule III. 14. Xanax is the brand name for alprazolam and is prescribed to treat anxiety. Alprazolam is a class of benzodiazepines. According to Section 893.03(4), Florida Statutes (2010-2011), alprazolam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule Ill and has a currently accepted medical use in treatment in the United States. Page 3 of 31 Abuse of alprazolam may lead to limited physical or psychological dependence relative to the substances in Schedule III. 15. Many of the drugs that are used for pai treatment are highly addictive, and are subject to abuse and diversion. 16. ‘Traveling long distances for pain medication is an indication that a patient may be abusing or involved diverting his or her medication. Facts Specific to Patient N.B. 17. Onor about February 11, 2010, N.B. was an unemployed, 46 year-old woman with a Maryland driver’s license who stated she had been in a car accident 20 years ago. 18. On or about February 11, 2010, N.B. presented to the clinic for the first time lower back and neck, and pain and numbness in her hands, The clinic’s medical records for N.B. include an incomplete Department of Social Services form which indicated that the patient had anxiety and depression and a magnetic resonance imaging report (MRI) from on or about August 26, 2009. 19. On or about February 11, 2010, tested positive for benzodiazepines, and THC, but she tested negative for oxycodone. | 20. THC (tetrahydrocannabinols) is the psychoactive ingredients in marijuana, OT cannabis. According to Section 893.03(1), Florida Statutes (2010- 2011), THC is a Schedule I controlled substance that has a high potential for abuse Page 4 of 31 and has no currently accepted medical use in treatment in Florida. Its use under medical supervision does not meet accepted safety standards, . 21. On or about February 11, 2010, the Respondent, saw N.B. and diagnosed her with multilevel degenerative disk disease. 22. On or about February 11, 2010, the Respondent prescribed 150 pills of Roxicodone 30 mg and 15 pills of Xanax 2 mg to the patient. 23. The Respondent failed to address why the patient was out-of-state and traveling to Florida for pain medication. 24. The Respondent prescribed excessive amounts of Roxicodone for the amount of justification provided in the medical records. 25. The Respondent failed to prescribe the patient extended release opiates or failed to explain why he failed to prescribe the patient extended release opiates. 26. The Respondent failed to offer the patient methods of treatment such as antiinflammatory medication, muscle relaxers, injections or trigger point injections. 27, The Respondent fails to address the patient’s anxiety diagnosis in his medical records. | 28. The Respondent failed to address why he was prescribing the patient large doses of oxycodone when the patient tested negative for oxycodone. Page 5 of 31 29. Given the patient’s use of THC, the Respondent failed to do one or more of the following: a. address the patient’s use of THC in his medical records; b. prescribed the patient extended release opioids, c. ‘refer the patient to substance abuse counseling; d. wait until the patient tested negative for THC before prescribing her opioids. Facts Specific to Patient R.B. 30. On or about February 11, 2011, R.B. presented to the clinic for the first time with complaints of lower back pain. R.B. was self-employed and stated he had a Florida address, but presented a Maine identification card. 31, R.B.’s medical records contained an MRI which was performed on or about February 11, 2011, but included no other medical records from previous health care providers. 32, On or about February 11, 2011, R.B. tested positive for opiates and benzodiazepines, but his medical records did not indicate that he had been prescribed benzodiazepines. 33. On or about February 11, 2011, the Respondent diagnosed R.B. with degenerative disk disease. Page 6 of 31 34, On or about February 11, 2011, the Respondent prescribed 150 pills of Roxicodone 30 mg to the patient. 35. The Respondent failed to address why the patient was coming from Maine to get treatment. 36, The Respondent’s prescribing was excessive in light of the Respondent’s examination, the patient’s MRI and the lack of documentation in the medical records. 37, The Respondent failed to get medical records from previous physicians and a prescription log from a pharmacy. 38. The Respondent failed to utilize non-controlled medication for the patient. Facts Specific to Patient L.W. 39. On or about February 11, 2011, L.W. presented to the clinic for the first time with complaints of lower back, shoulder and leg pain. 40. On or about February 11, 2011, L.W. was a 58 year-old female student who presented a drivers license with a Plymouth, Florida address. 41. The clinic's medical records contained MRI reports of the right shoulder and of the right hand, but no other medical records. 42. On or about February 11, 2011, L.W. was negative for all drugs tested. Page 7 of 31 43. Onor about February 11, 2011, L.W.’s medical records indicated that she was taking Valium, Percodan, oxycodone and Percocet at the time of her visit. 44. Percodan is the brand name for a drug that contains oxycodone and aspirin. Percodan is a Schedule II controlled substance according to Section 893.03(2), Florida Statutes (2010- 2011). 45. Percocet is the brand name of a drug which contains oxycodone and acetaminophen. (Acetaminophen is the drug in Tylenol.) According to Section 893.03(2), Florida Statutes, oxycodone. is a Schedule I controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States, 46. On or about February 11, 2011, the Respondent diagnosed the patient with supraspinatus tendonitis and degenerative disk disease. 47. On or about February 11, 2011, the Respondent wrote a prescription for an MRI of the spine and a prescription for 150 pills of Roxicodone 30 mg for LW. 48. The Respondent failed to address why L.W. was traveling several hours from north-central Florida to the clinic for pain medication. 49. The Respondent’s history and examination of the patient were inappropriate or inadequate for pain management purposes. Page 8 of 31 50. The Respondent failed to get information pertinent to pain management about the patient’s pain history, information about past drug regiments, type of treatments had been attempted and failed and medical records from previous physicians. 51. The Respondent failed to prescribe the patient non-controlled substances or less potent forms of controlled substances to the patient. 52, The Respondent prescribed controlled substances excessively or inappropriately to the patient. 53. The Respondent prescription of 150 tablets of Roxicodone 30 mg was excessive and potentially based on L.W.’s negative urine screen. Facts Specific to Patient B.D. 54, On or about February 11, 2010, B.D., a 36 year-old Delaware resident, presented to the clinic for the first time with complaints of lower back pain. 55. The clinic’s records for the patient includes an MRI reports of the lumbar spine from May 11, 2006, and March 1, 2009, and a prescription drug log from January 1, 2008, through January 29, 2010. 56. On or about February 4, 2011, the Respondent prescribed 180 pills of Roxicodone 30 mg, 60 pills of Roxicodone 15 mg, 30 pills of ibuprofen 600 mg, and 30 pills of Flexeril 10 mg to the patient. Page 9 of 31 57. On or about February 4, 2011, the Respondent’s long term goal consisted of “reduce pain” but did not articulate a treatment plan. 58. On or about February 11, 2010, the Respondent saw the patient again and diagnosed B.D. with central HNP. 59. Onor about February 11, 2010, B.D. was negative for all drugs tested during the drug screen performed at the clinic. 60, On or about February 11, 2010, the Respondent prescribed 180 pills of Roxicodone 30 mg and 60 pills of Roxicodone 15 mg to the patient. 61. Onor about February 11, 2010, the Respondent failed to address why the patient was coming from Delaware for treatment. 62. On or about February 11, 2010, the Respondents examination of the patient was inadequate for pain management purposes. 63. On or about March 4, 2011, B.D. returned to the clinic for a follow-up visit. During this visit, the Respondent prescribed 180 pills of Roxicodone 30 mg, 60 pills of Roxicodone 15 mg, 30 pills of Flexeril 10 mg, and 30 pills of ibuprofen 600 mg to B.D. 64. On or about March 4, 2011, the Respondent’s long term goal for the patient was to “reduce pain,” but he failed to articulate a treatment plan. 65. The Respondent fell below the standard of care of his treatment of B.D. Page 10 of 31 66. The Respondent failed to assess why the patient was coming from Delaware to receive pain management treatment. 67. The Respondent performed an inadequate physical and history for a pain management patient. 68. The Respondent failed to refer the patient to a board certified pain specialist or an orthopedic surgeon given the patient’s MRI reports. 69. Onor about February 11, 2010, the Respondent failed to address why the patient’s negative drug test when the Respondent had prescribed the patient Roxicodone on or about February 4, 2010. 70, On or about February 11, 2010, the Respondent prescribed and dangerous level of Roxicodone in light of on the patient’s negative drug screen. 71. On or about February 11, 2010, the Respondent’s prescribing was excessive and/or inappropriate based on the patient’s medical records, Facts Specific to Patent H.O. 72, On or about February 11, 2010, H.O. was a 38 year-old man gas station employee from Deland, Florida who visited the clinic for the first time with complaints of lower back pain. 73. On or about February 11, 201, H.O. had an MRI faxed directly to the clinic, but the clinic had no other medical records from previous health care providers. Page 11 of 31 74. On or about February 11, 2010, H.O. was negative for al] the drugs that were tested. 75. Onor about February 11, 2010, the Respondent diagnosed H.O. with degenerative disk disease. 76. On or about February 11, 2010, the Respondent prescribed 150 pills of Roxicodone 30 mg to the patient. 77. The Respondent failed to address why the patient was coming from Deland to the clinic. 78. The Respondent’s records did not justify the level of Roxicodone that he prescribed to the patient. 79, The Respondent failed to get medical records from previous treating health care providers. 80, The Respondent prescribed an excessive amount of opioids to the patient in light of the fact that the patient tested negative for opioids. 81. The patient’s MRI was normal for the patient’s age and did not justify a prescription of Roxicodone 30 mg five times a day. 82. The Respondent failed to discuss or provide the patient with non- opioid treatment options which might have been more appropriate for this patient. Page 12 of 31 Facts Related to Patient R.D. 83. On or about March 3, 2010, R.D. was a 43 year-old carpenter from Tennessee who presented to the clinic for the first time, with complaints of back pain. 84. R.D.’s medical records contain an MRI from a Fort Lauderdale clinic, but there were no records from previous physicians. 85, Onor about March 3, 2010, R.D. was seen by another physician at the clinic and he tested positive for THC during a drug screen. 86. On or about August 6, 2010, R.D. was seen by another physician at the clinic and he tested positive for THC during a drug screen. 87, Onor about October 28, 2010, R.D. retumed to the clinic and saw the Respondent. The Respondent noted that the patient had lower back pain since 2004, but had no known specific injury. The Respondent diagnosed the patient with degenerative disk disease. 88. On or about October 28, 2010, the Respondent stated that his long term goal for the patient was to “reduce pain” but he failed to articulate a treatment plan in the medical records. 89. On or about October 28, 2010, the Respondent prescribed 90 pills of Roxicodone 30 mg, 60 pills of Roxicodone 5 mg, 30 pills of Xanax 2 mg, 30 pills of ibuprofen 400 mg and 30 pills of Flexeril 10 mg to the patient. Page 13 of 31 90. On or about December 1, 2010, R.D. returned to the clinic and saw the Respondent. 91. On or about December 1, 2010, R.D. tested positive for methamphetamines on a drug screen during his visit. 92. On or about December 1, 2010, the Respondent failed to sites patient positive tested positive for methamphetamines. 93, Onor about December 1, 2010, the Respondent’s records indicate that he prescribed 120 pills of Roxicodone 30 mg, 60 pills of Roxicodone 15 mg, 30 pills of Xanax 2 mg, 30 pills of ibuprofen 600 mg and 30 pills of Flexeril 10 mg to the patient. | 94. The Respondent’s prescriptions for 120 pills of Roxicodone 30 mg, 60 pills of Roxicodone 15 mg, 30 pills of Xanax 2 mg, 30 pills of ibuprofen 600 mg and 30 pills of Flexeril 10 mg were dated December 2, 2010. 95, On or about December 2, 2010, R.D. returned to the clinic and tested positive for benzodiazepines but did not test positive for oxycodone. 96. The Respondent failed to address why the patient was coming from Tennessee for pain treatment. 97. The Respondent failed to assess the patient for aberrant drug behavior despite the fact that the patient was coming from out-of-state for pain management and had a history of testing positive for THC and methamphetamines. Page 14 of 31 98. The Respondent based on the patient’s aberrant drug behavior, the Respondent failed fell below the standard of care in one or more of the following ways: a. order appropriate drug screens; b. prescribe medications other than not immediate release opioids; c. make appropriate referrals pain management. 99. The Respondent inappropriately or excessively prescribed multiple combinations of Roxicodone to be taken several times a day which indicates that the Respondent had a poor understanding of the use of immediate release opioids. 100. The Respondent prescribed Xanax, which is an anti-anxiety tnedication, without diagnosing the patient with anxiety. 101. The Respondent failed to make non-opioid _ treatment recommendations. 102. The Respondent failed to make appropriate referrals for the patient. Facts Specific to Patient MP. 103. On or about December 30, 2009, M.P., a 48 year-old lobster fisherman from Maine presented to the clinic for the first time because of lower back pain. A physician at the clinic ordered an MRI the day of the visit. 104. There were no medical records from previous physicians included in the patient’s record. Page 15 of 31 105. On or about March 26, 2010, MP, retumed to the clinic and tested positive for THC and benzodiazepines. 106. On or about June 18, 2010, M.P. presented to the Respondent who diagnosed the patient with degenerative disk disease. 107. On or about June 18, 2010, the Respondent failed to drug test the patient even though the patient tested positive for THC on or about March 26, 2010. 108. On or about June 18, 2010, the Respondent's long term goal for the patient was to reduce his pain, but there was no treatment plan in the records. 109. On or about June 18, 2010, the Respondent prescribed 180 pills of Roxicodone 30 mg, 60 pills of Roxicodone 15 mg and 60 pills of Valium 10 mg to the patient. 110. On or about July 16, 2010, the Respondent prescribed 180 pills of Roxicodone 30 mg, 60 pills of Roxicodone 15 mg and 60 pills of Valium 10 mg to the patient. 111. The Respondent’s care of M.P. was below the standard of care. 112. The Respondent failed to explore why the patient was traveling from Maine to get opioid treatment in Florida. Page 16 of 31 113. The Respondent also fell below the standard of care by failing to address the patient’s positive drug screen for THC and by prescribing opioids to the patient even though he tested positive for THC. 114. The Respondent inappropriately prescribed multiple immediate release oxycodone, without medical justification. 115, The Respondent prescribed excessive amounts of opioids to the patient. Eacts Specific to Patient S.J. 116. On or about December 16, 2009, S.J., a 32 year-old, Ohio resident, presented to the clinic and was scen by another physician. 117. On or about December 16, 2009, the medical records indicate that S.J. had low back pain and that he tested positive for THC and benzodiazepines during the visit, The medical records did not contain any records from previous physicians. 118. On or about February 16, 2010, S.J. returned to the clinic and, again, tested positive for THC. 119. Onor about June 18, 2010, S.J. tested positive for THC a third time. 120. On or about June 18, 2010, the Respondent prescribed 160 pills of Roxicodone 30 mg, 60 pills of Roxicodone 15 mg and 15 pills of Xanax 2 mg to the patient. Page 17 of 31 121. On or about October 21, 2010, the Respondent prescribed 150 pills of Roxicodone 30 mg, 180 pills of Roxicodone 5 mg, 30 pills of ibuprofen 400 mg, 30 pills of Flexeril 10 mg, and 15 pills of Xanax 2 mg for S.J. 122, The Respondent failed to recognized that coming from out-of-state and testing positive for illegal substances are signs that a patient could be abusing or diverting the drugs that he was being prescribed. 123. The Respondent failed to prescribe the patient extend release opioids or other medications which are less subject to abuse than immediate release formulations of oxycodone. 124. The Respondent inappropriately and excessively prescribed the patient immediate release opioids. 125. The Respondent failed to refer the patient to a pain specialist. Facts Specific to Patient R.B. 126. On or about March 25, 2010, R.B., a 26 year-old, unemployed man from Kentucky presented to the clinic for the first time, because of pain in his neck, back and legs. 127. The medical records contain an MRI, but there were no records from previous treating health care providers. 128. On or about March 25, 2010, the patient was negative for all the drugs tested and R.B. was treated by another physician at the clinic. Page 18 of 31 129. The Respondent saw the patient on or about June 18, 2010. 130. On or about June 18, 2010, the Respondent’s long term goal for the patient was to reduce his pain, but no treatment plan was articulated in the records. 131. On or about June 18, 2010, the patient tested positive for morphine even though medical records do not indicate that he was prescribed the drug. 132. On or about June 18, 2010, The Respondent prescribed 180 tablets of Roxicodone 30 mg, 60 tablets of Roxicodone 15 mg, and 30 tablets of Xanax 2 mg to the patient. 133. The Respondent saw the patient on or about July 16, 2010. The Respondent prescribed 180 tablets of Roxicodone 30 mg, 60 tablets of Roxicodone 15 mg, and 30 tablets of Xanax 2. mg to the patient at the end of this visit. 134, The Respondent fell below the standard of care in his treatment of RB. 135. The Respondent failed to address why the patient was coming from Kentucky for opioid treatment. 136. The Respondent failed to perform or failed to document (or both) any clinical examination that would justify the level of drugs that he was prescribing the patient, 137. The Respondent inappropriately prescribed multiple doses of immediate release oxycodone to the patient. Page 19 of 31 138. The Respondent prescribed Xanax without an anxiety diagnosis or other medical justification. COUNT I 139. The Petitioner realleges and incorporates paragraphs one (1) through one hundred and thirty-eight (138) as if fully set forth in this count. 140. Section 458.331(1)(m), Florida Statutes (2010-2011), subjects a physician’s license to discipline for failing to keep legible, as defined by department rule in consultation with the board, medica! records that identify the licensed physician or the physician extender and supervising 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. 141. The Respondent failed to keep adequate medical records in one or more of the following ways: a. by failing to explain or address why one or more patients were traveling long distances to get pain management treatment, b. by failing to explain why he prescribed immediate release opioids one or more patients; Page 20 of 31 c. by failing to explain or address his medical reasoning for treating patients who were testing positive for illegal substances or substances which they had not been prescribed, d. by failing to explain or address why he was prescribing Xanax to patients without an anxiety diagnosis. 142. Based on the foregoing, Respondent has violated Section 458.331(1)(m), Florida Statutes (2010-2011), for failing to keep legible medical records. COUNT I 143. The Petitioner realleges and incorporates paragraphs one (1) through one hundred and thirty-eight (138) as if fully set forth in this count. 144. Section 458.331(1)(q), Florida Statutes (2010-2011), subjects a physician’s license to discipline for prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's professional practice. For the purposes of this paragraph, it shall be legally presumed that prescribing, dispensing, administering, mixing, or otherwise preparing legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician's professional practice, without regard to his or her intent. Page 21 of 31 145. The Respondent inappropriately or in excessive or inappropriate quantities, prescribed controlled substances other than in the course of his professional practice in one or more of the following ways: a. by inappropriately prescribing controlled substances to one or more of his patients without assessing them for signs of drug abuse or diversion; . by prescribing multiple doses of immediate release one or more of his patients without medical justification; . by prescribing immediate release opioids one or more of his patients when the standard of care was to prescribe extended release or non-controlled substances; . by prescribing potentially dangerous or lethal amounts of opioids to one or more of his patients who tested negative for opiates; by inappropriately prescribing Xanax to patients for insufficient or no medical reason, by inappropriately prescribing controlled substances to patients without having offered his patients altemative methods of controlling their pain, and/or Page 22 of 31 g. by inappropriately prescribing controlled substances to patients without having offered his patients when the standard of care would have been to prescribe less potent drugs. 146. Based on the foregoing, Respondent has Section 458.331(1)(q), Florida Statutes (2010-2011), for prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's professional practice. COUNT III 147. The Petitioner realleges and incorporates paragraphs one (1) through one hundred and thirty-eight (138) as if fully set forth in this count. 148. Section 458.331(1)(t), Florida Statutes (2010-2011), subjects a physician’s license to discipline for comunitting medical malpractice as defined in Section 456.50. Section 456.50, Florida Statutes (2010-2011), defines medical malpractice as the failure to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related to health care licensure. 149. ‘The level of care, skill, and treatment recognized in general law related to health care licensure’ means the standard of care specified in Section 766.102. Section 766.102(1), Florida Statutes (2010), defines the standard of care as (t]he prevailing professional standard of care for a given health care provider shall be that level of care, skill, and treatment which, in light Page 23 of 31 of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers. 150. The Respondent fell below the standard of care in one or more of the following ways: a. by failing to perform examinations of one or more of patients that were specific to pain management treatment; . by failing to obtain sufficient medical histories and/or previous medical records from one or more of this patients, by failing to assess one or more of his patients for aberrant drug behavior, such as drug seeking or drug diversion, : by prescribing multiple or high doses of immediate release formulations of oxycodone.to one or more of his patients with inadequate medical justification; . by prescribing lethal or dangerous doses of controlled substances to his patients who were testing negative for opioids; by failing to provide his patients with pain control treatment other than immediate release opioids, by failing to perform examinations that were pertinent to pain management on one or more patients, and/or . by failing to discharge the one or more patients who were exhibiting aberrant drug behavior. Page 24 of 31 151. Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes (2010-2011), subjects a physician’s license to discipline for committing medical malpractice. COUNT IV 152, The Petitioner realleges and incorporates paragraphs one (1) through one hundred and thirty-eight (138) as if fully set forth in this count. 153. Section 458.331(1)(nn), Florida Statutes. (2010-2011), subjects a physician’s license to discipline for violating any provision of this chapter or chapter 456, or any rules adopted pursuant thereto. 154, Florida Administrative Rule 64B8-9.013, Florida Administrative Code, titled Standards for the Use of Controlled Substances for the Treatment of Pain provides in pertinant part: (3) Standards. The Board has adopted the following standards for 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 physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities Page 25 of 31 or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment. (c) Informed Consent and Agreement for Treatment. The 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 physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician should employ the use of a written agreement between physician and patient outlining patient responsibilities, including, but not limited to: 1. Utine/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.¢., violation of agreement), , (d) Periodic Review. At reasonable intervals based on the individual circumstances of the patient, the 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 physician’s evaluation of the patient’s progress. If treatment goals are not being achieved, despite medication adjustments, the physician should reevaluate the appropriateness of continued treatment. The physician should monitor patient compliance in medication usage and related treatment plans. (e) Consultation. The physician should be willing to refer the patient as necessaty 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 requires extra care, monitoring, and documentation, and may require consultation with or referral to an expert in the management of such patients. (f) Medical Records. The physician is required to keep accurate and complete records to include, but not be limited to: 1. The medical history and physical examination, including history of drug abuse or dependence, as appropriate; 2, Diagnostic, therapeutic, and laboratory results; Page 26 of 31 3. Evaluations and consultations; 4. Treatment objectives; 5. [D]iscussion of risks and benefits; 6. Treatments; 7. Medications (including date, type, dosage, and quantity prescribed), 8. Instructions and agreements; and 9. Periodic reviews. Records must remain current and be maintained in an accessible manner and readily available for review. Records must remain current and be maintained in an accessible manner and readily available for review. 155, The Respondent violated Rule 64B8-9,013 in on or more of the following ways: a, by failing to conduct and document complete medical histories and physical examinations in the medical records for his patients, b. by failing to document the nature and intensity of one or more of his patient’s pain, their concurrent and past treatments for pain, their underlying or coexisting diseases or conditions, the effect of the pain on their physical and psychological function and any history of substance abuse; c. by failing to document the presence of one or more recognized medical indication for the use of a controlled substance; d. by failing to provide treatment plans for his patients that stated objectives that would be used to determine treatment success, such as pain relief and improved physical and psychosocial function, Page 27 of 31 and indicated if any further diagnostic evaluations or other treatments were planned; and/or e. by failing to refer his patients to specialists when necessary. 156. Based on the foregoing, ‘Respondent has violated Section 458.331(1)(nn), Florida Statutes (2010-2011), by violating Rule 64B8-9.013, Florida Administrative Code, COUNTY 157. The Petitioner realleges and incorporates paragraphs one (1) through one hundred and thirty-eight (138) as if fully set forth in this count. 158. Section 458.331(1)(gg), Florida Statutes (2010-2011), subjects a physician’s license to discipline for engaging in a pattern of practice when prescribing medicinal drugs or controlled substances which demonstrates a lack of reasonable skill or safety to patients, a violation of any provision of this chapter, a violation of the applicable practice act, or a violation of any rules adopted under this chapter or the applicable practice act of the prescribing practitioner. 159. ‘The Respondent has engaged in a pattern of practice when prescribing medicinal drugs or controlled substances which demonstrates a lack of reasonable skill or safety to patients in one or more of the following ways: Page 28 of 31 . by prescribing pain medication when there was inadequate or no reason in the medical records indicating that pain medication was warranted; . by prescribing multiple, immediate release opioids, which demonstrated a lack of understanding of the use and effect of those drugs; . by prescribing large and inappropriate doses of controlled substances to pain patients when alternative methods of treating pain were more appropriate; . by prescribing high doses of Roxicodone to patients who were testing negative for opiates and, therefore, were at greater risk of overdosing on opiate drugs; and/or . by prescribing Roxicodone to patients who had aberrant drug screens, 160. Based on the foregoing, Respondent has violated Section 458,331(1)(gg), Florida Statutes (2010-2011), by engaging in a pattern of practice when prescribing medicinal drugs or controlled substances which demonstrates a lack of reasonable skill or safety to patients, WHEREFORE, Petitioner respectfully requests that the Board of Osteopathic Medicine enter an order imposing one or more of the following Page 29 of 31 penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. Be7) SIGNED this 29 day of November, 2011. H. Frank Farmer, Jr, MD, PhD, FACP State Surgeon General TON FR ON a Grace Kim Assistant General Counsel FILED DOH Prosecution Services Unit DEPA Cera eennms 4052. Bald Cypress Way, Bin C-65 CLERK Angel Sanders Tallahassee, FL 32399-3265 NOV 29 2ott Florida Bar # 31096 (850) 245-4640, Ext. 8187 PHONE (850) 245-4681 FAX PCP: November 28, 2011 PCP Members: Dr. Leon, Dr. Orr, Mr. Mullins Page 30 of 31 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, Page 31 of 31

Docket for Case No: 12-000165PL