Sep 18 2009 14:2 Sep 18 2009 14:16 P03 qi Lb ! STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, CASE NO. 2006-28876 Vv. DOUGLAS SMITH, M.D. RESPONDENT. ee 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, Douglas Smith, M.D., and in support thereof alleges: | Petitioner is the state department charged with regulating the 1. practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. At all times material to this complaint, Respondent was a 2. licensed physician within the state of Florida, having been issued license number ME 62450, Sep 18 2009 14:21 Sep 18 2009 14:17 P. O04 ‘wl! w" 3. Respondent's address of record is 1010: Bucida Road, Delray Beach, Florida 33483. | 4. On or about November 29, 2005, Patient J.S,, a forty-nine (49) year old male, presented to Respondent complaining of back pain, 3. Respondent prescribed Oxycontin 40 mg every 12 hours (60 tablets) and Roxicodone 30 mg every 4 hours (150 tablets). 6. Oxycontin is a semi-synthetic opiate that contains oxycodone hydrochloride, a Schedule II controlled substance defined in Chapter 893, Florida Statutes, which is indicated for the relief of moderate to severe pain. Oxycontin has a high potential for abuse and has a currently accepted, but limited, medical use in treatment in the United States. Abuse of this substance may lead to severe physical and psychological dependence. , 7. Roxicodone contains oxycodone hydrochloride. 8. Oxycodone hydrochloride, a semi-synthetic narcotic analgesic, is a Schedule IT controlled substance under Chapter 893, Florida Statutes, It 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 DOH v. Douglas R. Smith, M.D., Case No, 2006-28876 2 Sep 18 2009 14:21 Sep 18 2009 14:17 P.O5 ‘el wr’ use in treatment in the United States, and abuse of the substance may lead to severe physical and psychological dependence. 9. On or about December 21, 2005, Respondent prescribed 80 mg Oxycontin every 12 hours (60 tablets) and Roxicodone 30 mg every 4 hours (150 tablets) for 1.5, , 10. On or about January 11, 2006, Respondent prescribed 80 mg Oxycontin every 12 hours (60 tablets) and Roxicodone 30 mg. every 1-4 hours as needed (150 tablets) for 3.5. 11. On or about February 6, 2006, Respondent prescribed 80 mg Oxycontin every 12 hours (60 tablets) for J.S. 12. On or about March 1, 2006, Respondent prescribed Roxicodone 30 mg every 4 hours (150 tablets) for 3.5. 13. On or about April 19, 2006, Respondent prescribed the following medications for J.S.: a Oxycontin 80 mg, 2 every 12 hours (120 tablets); b. Roxicodone 30 mg 1-2 every 4 hours as needed (200 tablets); : ¢. a Duragesic patch (1 every 72 hours), DOH v, Douglas R. Smith, M.D., Case No. 2006-28876 3 Sep 18 2009 14:22 Sep 18 2009 14:17 P. O06 wa we 14. A Duragesic patch is applied to the skin so that the medication it contains is slowly absorbed. 2 15. Duragesic patches contain Fentanyl, a Schedule IT controlled substance under Chapter 893, Florida Statutes. Fentanyl is an opioid indicated in the management of chronic pain in patients. It has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States. Abuse of Fentanyl may lead to severe physical and psychological dependence. | 16, Respondent's medical records for J.S. for April 19, 2006 do not document justification for the addition of the Duragesic patch to ).S/ medication regimen. , 17 On or about May 17, 2006, Respondent prescribed the following medications for J.S.: | a. Oxycontin 80 mg, 2 every 12 hours (120 tablets); b. —_Roxicodone 30 mg 1-2 every 4 hours as needed (300 tablets); } i ¢. Duragesic patch 100 meg/hr, 1 patch every 2 days (15 patches). DOH v. Douglas R. Smith, M.D.. Case No. 2006-28876 . 4 Sep 18 2009 14:22 Sep 18 2009 14:17 P.O? wd Ad 18. On or about June 13, 2006, Respondent prescribed the following medications for J.S.: a. Oxycontin 80 mg, 2 every 12 hours (120 tablets); b. Roxicodone 30 mg, 1-2 every 4 hours as needed (100 tablets); i Cc. Duragesic patch 100 mca/hr, 1 patch every 2 days (15 patches). 19. Respondent continued to prescribe the same combination of medications as described above in paragraph 17 on July 11, 2006, August 8, 2006, September 6, 2006, October 5, 2006 and November 2, 2006. 20. Respondent did not conduct or did not document conducting a physical examination of J.S. on August 8, 2006, September 6, 2006 or October 5, 2006. 21. Respondent failed to coordinate his care of J.$. with 3.5, other physicians, including his primary care physician. 22. Respondent failed to monitor J.S. with urine drug screens. 23. Respondent’s medical records for JS. do not document justification for prescribing Oxycontin and Roxicodone simultaneously, DOH v. Douglas R. Smith, M.D., Case No. 2006-28876 / 5 Sep 18 2009 14:22 Sep 18 2009 14:17 P. 08 st ‘wr’ 24. Respondent's medical records for J3.$. do not. : document justification for prescribing Oxycontin, Roxicodone and the Duragesc patch simultaneously, | 25, Respondent's medical records for J.S. do not ‘document justification for changes in medications or changes in dosages of the medications. COUNT ONE 26. Petitioner realleges and incorporates paragraphs one (1) through twenty-five (25) as if fully set forth herein. , 27. Section 458,331(1)(t), Florida Statutes (2005-2006) provides that the failure to practice medicine with that level of care, ski, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances is grounds for disciplinary action by the Board of Medicine. 28. Rule 6488-9.013(3), Florida Administrative Code (FACY, which is part of the chapter of the FAC where the Board of Medicine establishes Standards of care for physicians, provides in relevant part: 6468-9.013 Standard for the Use of Controlled Substances for the Treatment of Pain. (1) Pain Management Principles. DOH v, Douglas R. Smith, M.D., Case No. 2006-28876 : 6 Sep 18 2009 14:22 Sep 18 2009 14:18 P.09 ai" ~~’ (a) The Board of Medicine recognizes that principles of quality medical practice dictate that the people of the State of Florida have access to appropriate and effective pain relief. The appropriate application of up-to-date knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as reduce the morbidity and costs associated with untreated or inappropriately treated pain. The Board e courages physicians to view effective pain management as part of quality medical practice for all patients with pain, acute or chronic, and it is especially important for patients who experience pain as a result of terminal illness. All physicians should become knowledgeable about effective methods of pain treatment as well as _ statutory requirements for prescribing controlled substances. * * * (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. 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. 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 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. 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 DOH v, Douglas R. Smith, M.D., Case No, 2006-28876 : 7 Sep 18 2009 14:23 Sep 18 2009 14:18 P.10 Naw! ~~ 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 a physician for failing to adhere strictly to the provisions of these standards, if good cause is shown for such deviation. The 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 patient’s individual needs 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 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 standards 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) 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 DOH v. Douglas R. Smith, M.D., Case No. 2006-28876 Sep 18 2009 14:23 Sep 18 2009 14:18 PTT ~~ \w 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, : DOH v. Douglas R. Smith, M.D., Case No, 20006-28876 Sep 18 2009 14:25 Sep 18 2009 14:19 PlL12 ~~ ‘ew (e) 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. (9) Compliance with Controlled Substances Laws and Regulations, To prescribe, dispense, or administer controlled Substances, the physician must be licensed in the state and comply with applicable federal and state regulations, 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. 29. Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar DOH v. Douglas R. Smith, M.D., Case No. 2006-28876 10 Sep 18 2009 14:24 Sep 18 2009 14:19 P.13 al! ‘oe physician as being acceptable under similar conditions and circumstances in one or more of the following ways: | a. By prescribing Oxycontin and Duragesic patch simultaneously for J.S. without justification; | b. By __ prescribing Oxycontin, Duragesic patch and Roxicodone simultaneously for patient J.S. without Justification; Cc. By failing to comply with Rule 64B8-9.013(3)(a), Florida Administrative Code, which provides that a complete medical history and physical examination must be conducted and documented in the medical record. 3 30. Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes (2005-2006), by failing 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 circurnstances. : COUNT TWO 31. Petitioner realleges and incorporates paragraphs ione (1) through twenty-five (25) as if fully set forth in this count. DOH v. Douglas R, Smith, M.D,, Case No, 2006-28876 : It Sep 18 2009 14:24 Sep 18 2009 14:19 P14 wel Sol 32. Section 458,331(1)(q), Florida Statutes (2005-2006), provides that 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 constitutes grounds for disciplinary action by the Board of Medicine. 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. 33. Respondent inappropriately prescribed controlled substances to J.S, other than in the course of his Professional practice by prescribing without any documented justification for the medications, changes in medications or changes in dosages of the medications. 34. Based on the foregoing, Respondent has violated Section 458.331(1)(q), Florida Statutes (2005-2006), by 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 shail be ® legally DOH v. Douglas R. Sinith, M.D., Case No. 2006-288 76 Sep 18 2009 14:24 Sep 18 2009 14:20 P.15 wel od 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, COUNT THREE | 35. Petitioner realleges and incorporates Paragraphs one (1) through twenty-five (25) as if fully set forth in this count. 36. Section 458.331( iX(m), Florida Statutes (2005- 2006), Provides that 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 justi the course of treatment of the patient, including, but not limited t, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations constitutes grounds for disciplinary action by the Board of Medicine. DOH v. Douglas R. Smith, M.D., Case No. 2006-28876 . 3 Sep 18 2009 14:24 Sep 18 2009 14:20 P.16 Nepe’ 37. Respondent failed to keep medical records that justity the course of treatment of J.S. in one or more of the following ways: ! a. By failing to document the justification for prescribing Oxycontin and Duragesic patch in the dosages and circumstances that he did; : b. By failing to document the justification for prescribing Oxycontin, Duragesic patch and Roxicodone in the dosages and circumstances that he did; | c. By failing to document a complete medical history or complete physical examination. | 38. Based on the foregoing, Respondent has violated Section 458.331(1)(m), Florida Statutes (2005-2006), by failing to keep 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. ! 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 DOH v. Douglas R. Smith, M.D., Case No, 2006-28876 14 Sep 18 2009 14:25 Sep 18 2009 14:20 PL? we ‘we! 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 3°" dayof_ /77e-<4 2008. Ana M. Viamonte Ros, M, D, M.PH. State Surgeon General sistant General Counsel DOH-Prosecution eWeek Unit 4052 Bald Cypress Way-Bin C-65 1-7 Tallahassee, Florida 32399-3265 Florida Bar #0544825 (850) 245-4640 (850) 245-4680 fax PCP: February 29, 2008 Panel: Dr. El-Bahri, Dr, Davies, Ms. Long DOH v. Dougias R. Smith, M.D., Case No. 2006-28876 15 Sep 18 2009 14:25 Sep 18 2009 14:20 P.18 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 proseaition of this matter. Pursuant to Section 456.072(4), Florida Statutes, the soar 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. DOH v. Dougias R. Smith, M.D., Case No. 2006-28876 . : 16

Docket for Case No: 09-005176PL