STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, Vv. CASE NO.: 2008-20661 JACINTA IRENE GILLIS, M.D., RESPONDENT. ey | ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Medicine against Respondent, Jacinta Irene Gillis, M.D., and in support thereof alleges: 1. Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. 2. At all times material to this Complaint, Respondent was a ticensed physician within the State of Florida, having been issued license number ME 99298. Filed August 11, 2011 3:58 PM Division of Administrative Hearings 3. Respondent’s address of record is 12446 Pebble Stone Court, Fort Myers, Florida, 33913. 4. At all times material to this cause between June 2008 and December 2008, Respondent treated patients R.S., D.H., M.N., and A.W. 5. The Department of Health (Department) initiated an investigation of Respondent based on an undercover investigation conducted by the Pinellas County Sheriffs Office (PCSO). 6. It was alleged that Respondent was issuing prescriptions for controlled substances to undercover agents of the PCSO without conducting adequate physical examinations. 7. The types of controlled substances in question that were prescribed by Respondent are listed as follows: a) Oxycodone (opioid) is commonly prescribed to treat pain. 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. Abuse of oxycodone may lead to severe psychological or physical dependence. b) Percocet (opioid) is the brand name for the formulation of oxycodone and acetaminophen and is prescribed to treat pain. C) Alprazolam (benzodiazepine) is often sold under the brand name Xanax, and is prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes, alprazolam 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 the substance may lead to limited physical or psychological dependence relative to the substances in Schedule III. d) Carisoprodol, commonly known by the brand name Soma, is a muscle relaxant prescribed to treat muscular pain. According to Section 893.03(4), Florida Statutes, carisoprodol 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 carisoprodol may lead to limited physical or psychological dependence relative to the substances in Schedule III. 8. In medicine, a proper medical assessment includes the patient's prior medical history, prior pain management treatment history, intensity of pain, factors that make the pain worse or alleviate the pain, the pain’s intensity and location, verification of prior controlled substance prescriptions including the date and quantity of the last prescription received, name of the previous treating physician, name and address of the pharmacy where the last controlled substance prescriptions were filled together with all relevant contact information and verification of all the foregoing by the physician personally contacting the previous pharmacy and treating physician, together with the reason for the referral, and verification for the reasons of referral with the prior treating physician. FACTS SPECIFIC TO R.S. 9. On or about August 27, 2008, R.S. presented to Respondent with complaints of back and shoulder pain. 10. Respondent’s medical records show that she prescribed Percocet 10/325, ninety (90) pills to R.S. 11. Respondent did not obtain any medical documentation, records, or correspondence from any other physician of R.S. 12. Respondent did not perform a thorough and complete medical assessment of R.S. 13. Respondent did not accurately and completely document performing a complete medical assessment of R.S. or accurately and completely document any medical justification for not doing so. 14. Respondent did not review medical records from other physicians, pharmacists, or health care professionals of R.S. 15. Respondent did not accurately and completely document reviewing any medical records from other physicians, pharmacists, or health care professionals of R.S., or accurately and completely document any medical justification for not doing so. 16. Respondent did not communicate with R.S.’s previous physicians, pharmacists, or health care professionals. 17, Respondent did not accurately and completely document communicating with R.S.’s previous physicians, pharmacists, or health care professionals, or accurately and completely document any justification for “not doing so. 18. Respondent did not perform a urine drug screen. 19. Respondent did not accurately and completely document performing a urine drug screen, or accurately and completely document justification for not doing so. 20. Respondent’s medical record did not adequately provide justification for the prescribing of Percocet as described in paragraph ten (10) to R.S. FACTS SPECIFIC TO D.H. 21. From on or about August 4, 2008 to on or about August 27, 2008 D.H. presented to Respondent with complaints of back and neck pain. 22. Respondent's medical records show she prescribed one hundred twenty (120) pills of oxycodone thirty (30) mg. and ninety (90) pills of Motrin six hundred (600) mg. on August 4, 2008. 23. Respondent's medical records show she prescribed one hundred twenty (120) pills of oxycodone thirty (30) mg. on August 27°, 2008. 24. Respondent did not obtain any medical documentation, records, or correspondence from any other physician of D.H. 25. Respondent did not perform a complete and thorough medical assessment of patient D.H. 26. Respondent did not accurately and completely document performing a complete medical assessment, or accurately and completely document any medical justification for not doing so. 27. Respondent did not obtain or review prior medical records from any other physician, pharmacist, or health care professional. 28. Respondent did not accurately and completely document reviewing any medical records from any other physician, pharmacist, or health care professional or accurately and completely document any medical justification for not doing so. 29. Respondent did not obtain a urine drug screen. 30. Respondent did not provide justification in the medical records for prescribing oxycodone 30 mg as described in paragraphs twenty two (22) and twenty three (23). FACTS SPECIFIC TO M.N. 31. From on or about June 23, 2008 through on or about November 10, 2008 M.N. presented to Respondent with complaints of lower back, left knee and right shoulder pain. 32. On or about June 23, 2008 Respondent prescribed sixty (60) pills of Xanax 1 mg. and two hundred ten (210) pills of oxycodone 30 mg. 33. On or about July 18, 2008 Respondent prescribed thirty (30) pills of amoxicillin five hundred (500) mg. and two hundred ten (210) pills of oxycodone 30 mg. 34. On August 13, 2008 Respondent prescribed one hundred eighty (180) pills of oxycodone 30 mg. 35. On September 10, 2008 Respondent prescribed two hundred ten (210) pills of oxycodone 30 mg. 36. On October 7, 2008 Respondent prescribed one hundred eighty (180) pills of oxycodone 30 mg. 37, On November 10, 2008 Respondent prescribed one hundred fifty (150) pills of oxycodone 30 mg. 38. Respondent did not perform a thorough and complete physical examination of M.N. 39. Respondent did not obtain a urine screen of M.N. 40. Respondent did not perform a complete and thorough medical assessment of M.N. 41. Respondent did not accurately and completely document performing a complete medical assessment of M.N., or accurately and completely document any medical justification for not doing so. 42. Respondent did not provide justification in the medical record for prescribing Xanax to M.N. 43. Respondent did not provide justification in the medical record for prescribing oxycodone thirty (30) mg. to M.N. FACTS SPECIFIC TO A.W. 44. From on or about June 20, 2008 through on or about October 28, 2008, A.W. presented to Respondent with pain shooting down the arms and hands. 45. On or about June 20, 2008 Respondent prescribed thirty (30) pills of Zoloft 50 mg., and one hundred fifty (150) pills of oxycodone 30 mg. 46. On or about June 27, 2008 Respondent prescribed sixty (60) pills of Xanax 1 mg. and sixty (60) pills of Soma 350 mg. 47. On or about July 16, 2008 Respondent prescribed thirty (30) pills of Zoloft 50 mg. and one hundred eighty (180) pills of oxycodone 30 mg. 48. On or about September 29, 2008, Respondent prescribed one hundred eighty (180) pills of oxycodone 30 mg. and sixty (60) pills of Advil 400 mg. 49. On or about October 28, 2008 Respondent prescribed two hundred (200) pills of oxycodone 30 mg. and sixty (60) pills of Advil 400 mg. 50. Respondent did not perform a urine screen during the time she treated A.W. even though high dose opiates were prescribed. 51. Respondent did not provide justification in the medical records for prescribing oxycodone 30mg as described in paragraphs forty five (45) and forty seven (47) through forty nine (49). 52. Respondent did not provide justification in the medical records for prescribing Xanax to A.W. as there is not an adequate discussion of anxiety disorder in the record. 53. Respondent did not provide justification in the medical records for prescribing Soma to A.W. as described in paragraph forty six (46). COUNT ONE 54. Petitioner reincorporates and re-alleges paragraphs 1 through fifty three (53) as if fully set forth herein. 95. Section 458.331(1)(nn), Florida Statutes (2007, 2008, 2009), provides that violating any provision of Chapters 456 or 458, Florida Statutes, or any rules adopted pursuant thereto is grounds for discipline by the Board of Medicine. 56. Rule 64B8-9.013(3), Florida Administrative Code (2007,2008,2009) provides as follows: 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 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. —_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 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. €) Consultation. The 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 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; 3. Evaluations and consultations; 4. Treatment objectives; 5. Discussion 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. 57. Respondent violated Rule 64B8-9.013(3), Florida Administrative Code (2007, 2008, 2009) in one or more of the following ways: a) _ by failing to conduct a complete medical history and physical examination of R.S., D.H., M.N., or AW.; b) by failing to explore other treatment modalities or rehabilitation for R.S., D.H., M.N., or A.W.; 58. Based on the foregoing, Respondent has violated Section 458.331(1)(nn), Florida Statutes (2007, 2008, 2009), by violating Rule 64B8-9.013(3), Florida Administrative Code (2007, 2008, 2009). COUNT TWO 59. Petitioner reincorporates and realleges paragraphs 1 through fifty three (53) as if fully set forth herein. 60. Chapter 64B8-9.013(3), Florida Administrative Code (2007, 2008, 2009) as more particularly set forth in paragraph fifty six (56) is adopted and re-alleged as if fully set forth herein. 61. Section 458.331(1)(m), Florida Statutes (2007, 2008, 2009) provides: failing to keep legible, as defined by department rule in consultation with the board, medical 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 and a violation thereof constitutes grounds for disciplinary action by the Board. 62. Respondent failed to keep legible medical records justifying the course of treatment for patients R.S., D.H., M.N., or A.W. in one or more of the following ways: a) _ by failing to keep medical records that justified the course of treatment of R.S., by failing to record the justification for prescribing Percocet as described in paragraph ten (10). b) _ by failing to keep medical records that justified the course of treatment of D.H., by failing to record the justification for prescribing oxycodone thirty (30) mg. as described in paragraphs twenty two and twenty three (23). c) _ by failing to keep medical records that justified the course of treatment of M.N., by failing to record the justification for Prescribing Xanax or oxycodone thirty (30) mg. as described in paragraphs thirty two (32) through thirty seven (37). d) _ by failing to keep medical records that justified the course of treatment of A.W., by failing to record the justification for prescribing oxycodone thirty (30) mg., Xanax, or Soma as described in paragraphs forty five (45) through forty nine (49) . 63. Based on the foregoing, Respondent violated Section 458.331(1)(m), Florida Statutes (2007, 2008,2009) by failing to keep legible medical records that justify the course of treatment for patient R.S. and/or patient D.H. and/or patient M.N. and/or patient A.W., 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 THREE 64. Petitioner reincorporates and realleges paragraphs 1 through fifty three (53). 65. Section 458.331(1)(q), Florida Statutes (2007, 2008 2009), subjects a licensee to discipline for prescribing controlled ‘substances inappropriately or in excessive or inappropriate quantities. 66. Section 458.331(1)(q) states the following acts constitute grounds for disciplinary action: 17 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 alt 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. 67. Respondent prescribed controlled substances other than in the course of her professional practice by prescribing controlled substances inappropriately or excessively to R.S, D.H., M.N., or A.W in one or more of the following ways: a) _ by prescribing controlled substances without an adequate medical assessment of R.S., D.H., M.N., or A.W.; . b) _ by prescribing controlled substances without an adequate physical examination of R.S., D.H., M.N., or A.W, Cc) by prescribing controlled substances without ordering | urine drug screening to R.S., D.H., M.N., or AW.; d) by prescribing Xanax to M.N. or A.W. without an adequate discussion of anxiety disorder. 68. Based on the foregoing, Respondent has violated Section 458.331(1)(q), Florida Statutes (2007, 2008, 2009). COUNT FOUR 69. Petitioner reincorporates and re-alleges paragraphs 1 through fifty three (53) as if fully set forth herein. 70. Chapter 64B8-9013(3), Florida Administrative Code, as more particularly set forth in paragraph fifty six (56) herein is adopted and realleged as if fully set forth herein. 71. Section 458.331(1)(t), Florida Statutes (2007, 2008, 2009), subjects a licensee to discipline for committing medical malpractice as defined in Section 456.50, Florida Statutes. Section 456.50, Florida Statutes (2007, 2008, 2009) 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. 72. For purposes of Section 458.331(1)(t), Florida Statutes, the Board of Medicine shall give great weight to the Provisions of Section 766.102, Florida Statutes (2007, 2008, 2009) which provide that the prevailing professional standard of care for a given health care provider shall be that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers. 73. Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances in treating R.S., D.H., M.N., or A.W. in one or more of the following ways: a) by prescribing controlled substances inappropriately or in excessive or inappropriate amounts to R.S., D.H., M.N., or A.W. ; b) by failing to note in the medical records in prescribing Xanax that M.N. or A.W. was suffering from an anxiety disorder; C) by failing to order urine drug screening to R.S., D.H., M.N. or A.W. in light of the dosages of controlled substances prescribed; 20 74. d) by failing to show in the medical record the justification for prescribing controlled substances to R.S., D.H., M.N., or A.W., €) by failing to perform a complete physical examination on R.S., D.H., M.N., or A.W., f) by prescribing controlled substances to R.S, D.H., M.N., or A.W., in quantities and dosages as previously outlined, without justification. g) by failing to perform a complete medical assessment of R.S., D.H., M.N., or A.W, Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes (2007, 2008, 2009). WHEREFORE, the Petitioner respectfully requests that the Board of 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. SIGNED this_6‘* day of “Uw. , 2011, FILED DEPARTMENT OF HEALTH DEPUTY CLERK CLERK Angel Sanders pate JUN 07 2011 RJB/das PCP Members: Mullins & Tucker PCP: June 6, 2011 H. Frank Farmer, Jr., M.D., Ph.D., State Surgeon General Department of Health Robert J. Bobek Assistant General Counsel Florida Bar # 434337 DOH Prosecution Services Unit 4052 Bald Cypress Way-Bin C-65 Tallahassee, Florida 32399-3265 (850) 245-4640 Office (850) 245-4681 Facsimile 22 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 his 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. 23

Docket for Case No: 11-004058PL