CY- JOO STATE OF FLORIDA ro cs DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, aan: Hes ai The jive Petitioner, vs. CASE NO. 2002-22900 MARK K. SACHS, M.D., Respondent. ___/ ADMINISTRATIVE COMPLAINT COMES NOW Petitioner, Department of Health, by and through undersigned counsel, and files this Administrative Complaint before the Board of Medicine against Respondent, Mark Sachs, M.D., and 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 hereto, Respondent has been a duly licensed physician in the State of Florida, having been issued license number ME 49598. 3. Respondent's address of record is 7031 SW 62 Avenue, 5™ Floor, Miami, Florida 33143. 4. Respondent is Board certified in Internal Medicine. 5. Onor about August 7, 2002, Patient H.Y., a 37 year-old female resident of California, completed an on-line questionnaire requesting 90 caps of Phentermine 30 mg. 6. Onor about August 7, 2002, Respondent prescribed to Patient H.Y. 90 caps of Phentermine 30 mg. 7. Phentermine is a schedule IV controlled substance as set forth in Chapter 893, Florida Statutes, that contains phentermine hydrochloride used for weight loss. Phentermine has a potential for abuse that may lead to limited physical or psychological dependence. 8. Phentermine is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. Phentermine is indicated for obese patients with an initial body mass index (BMI) 230 kg/m’, or 227 kg/m’ in the presence of other risk factors (e.g. hypertension, diabetes, hyperlipidemia). Phentermine is contraindicated in patients with advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, or glaucoma. 9. Section 458.336, Florida Statutes (2002), provides that the Florida Board of Medicine shall adopt rules that establish practice guidelines for physicians to safely prescribe phentermine, fenfluramine, and other drugs used to treat obesity. 10. Board of Medicine Rule 64B8-9.012, Florida Administrative Code (FAC), establishes the standards for the prescription of obesity drugs. In pertinent part the rule requires the following: 1) to justify the use of weight loss enhancers, a patient must have a Body Mass Index of 30 or greater, or a BMI of greater than 27 with at least one comorbidity factor; 2) an initial evaluation of the patient prior to prescribing, ordering, dispensing or administering, which shall include an appropriate physical and complete history, appropriate tests related to medical treatment and appropriate medical referrals; 3) at the time of delivering the initial prescription or initial supply, the prescribing physician must personally meet with the patient and personally obtain an appropriate written informed consent from the patient, and a copy of the signed informed consent shall be included in the patient’s permanent medical record; 4) each physician who prescribes, orders or provides the weight loss enhancers must ensure that the patient undergoes an in-person re-evaluation within 2 to 4 weeks of receiving the prescription, order or dosage; 5) each physician who prescribes, orders or provides the weight loss enhancers shall maintain medical records in compliance with Rule 64B8-9.003, FAC; and 6) each physician who prescribes, orders or provides the weight loss enhancers shall provide to each patient a legible copy of the Weight-Loss Consumer Bill of Rights. 11. Respondent did not calculate Patient H.Y.’s BMI or measure her weight or height prior to prescribing her Phentermine. 12. Respondent did not conduct an initial evaluation, including an appropriate physical and complete history, appropriate tests related to medical treatment and appropriate medical referrals of Patient H.Y. prior to prescribing, ordering, dispensing or administering Phentermine. 13. Respondent did not, at the time of delivering the initial prescription for Patient H.Y., personally meet with H.Y. and obtain an appropriate written informed consent from H.Y., and place a copy of the signed informed consent in Patient H.Y.’s permanent medical record. 14. Respondent did not ensure that Patient H.Y. underwent an in- person re-evaluation within 2 to 4 weeks of receiving the prescription for Phentermine. 15. Rule 64B8-9.003, Florida Administrative Code, (FAC) provides, in relevant part: 64B8-9.003 Standards for Adequacy of Medical Records. * * * (3) The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course of and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient. 16. Respondent did not maintain medical records in compliance with Rule 64B8-9.003, FAC, regarding Patient H.Y.’s prescription of Phentermine, or any patient history, physical, diagnosis or treatment plan regarding her. 17. Respondent did not provide Patient H.Y. a legible copy of the Weight-Loss Consumer Bili of Rights. 18. Respondent relied solely on information contained within the on-line questionnaire order form for prescribing Phentermine to Patient H.Y. 19. Respondent did not determine and/or verify any potential contraindications in Patient H.Y. prior to prescribing Phentermine. 20. Respondent did not exclude any organic causes of Patient H.Y.’s alleged obesity nor did Respondent have any laboratory analysis performed prior to prescribing Phentermine to Patient H.Y. 21. Respondent dicl not advise Patient H.Y. to adhere to any dietary guidelines prior to prescribing Phentermine. 22. Respondent did not provide any plan of care, follow-up care, or monitoring prior to, or at any time following, his prescribing Phentermine to Patient H.Y. 23. Respondent is without appropriate medical records relative to Respondent’s examination, consultation, tests and related medical issues justifying the Phentermine prescription to Patient H.Y. 24. The prescription issued by Respondent for ninety (90) Phentermine 30 mg. was filled by Superior Drugs, Miami, Florida 33143. 25. On or about August 10, 2002, Fed Ex delivered a package to Patient H.Y.’s home office containing the Phentermine prescription that was prescribed by Respondent. COUNT I- STANDARD OF CARE 26. Petitioner re-alleges and incorporates paragraphs one (1) through twenty-five (25) as if fully set forth herein. 27. Section 458.331(1)(t), Florida Statutes (2002), provides that gross or repeated malpractice or the failure 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 constitutes grounds for disciplinary action by the Board of Medicine. 28. Chapter 64B8-9, FAC, sets forth standards of practice for medical doctors. Rule 64B8-9.003(2), FAC, defines the standard of practice for adequacy of medical records and provides that a licensed physician shall maintain patient records in a legible manner and with sufficient detail to clearly demonstrate why the course of treatment was undertaken or why an apparently indicated course of treatment was not undertaken. 29. 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 circumstances, in one or more of the following ways: a) Respondent failed to establish a doctor-patient relationship; b) Respondent failed to perform a physical examination of Patient H.Y.; c) Respondent failed to verify patient medical information; d) Respondent failed to verify Patient H.Y.’s need for Phentermine; e)* Respondent failed to verify Patient H.Y.’s vital signs, such as height, weight, and blood pressure; f) Respondent failed to rule out other causes for Patient H.Y.’s alleged obesity, such as hypothyroidism; g) Respondent failed to establish a plan of care; h) Respondent failed to establish any follow-up or monitoring, without which Patient H.Y. could suffer potential harm if there was abnormal weight loss or malabsorption of vitamins and minerals; i) Respondent failed to order any laboratory analysis; and/or j) Respondent failed to maintain medical records justifying the course of treatment. 30. Based on the foregoing, Respondent violated Section 458.331(1)(t), Florida Statutes (2002), by failing to practice medicine with that level of care, skill and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. COUNT II — MEDICAL RECORDS 31. Petitioner re-alleges and incorporates paragraphs one (1) through twenty-five (25) as if fully set forth herein this Count Two. 32. Section 458.331(1)(m), Florida Statutes (2002), 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 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 disciplinary action by the Board of Medicine. 33. Rule 64B8-9.003, FAC, provides, in relevant part the standards for adequacy of medical records. 34. Respondent failed to keep written medical records justifying the course of treatment of Patient H.Y., in that Respondent has failed to provide any medical records that Respondent recorded an adequate medical history on the patient, or that the records justify the treatment of Patient H.Y. with Phentermine. 35. Based on the foregoing, Respondent violated Section 458.331(1)(m), Florida Statutes (2002), and Rule 64B8-9.003, Florida Administrative Code, by failing to keep legible, as defined by department rule in consultation with the board, 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 III- INAPPROPRIATE PRESCRIBING 36. Petitioner realleges and incorporates paragraphs one (1) through twenty-five (25) as if fully set forth herein this Count Three. 10 37. Section 458.331(1)(q), Florida Statutes (2002), provides that a physician may be subject 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. 38. Rule 64B8-9.012, Florida Administrative Code, provides that the prescription of medication for the purpose of enhancing weight loss should only be performed by physicians qualified by training and experience to treat obesity. Also, Rule 64B8-9.012, Florida Administrative Code, sets forth guidelines and standards by which obesity drugs shall be utilized and requires all licensees to comply with such guidelines and standards in the utilization of any drug, any synthetic compound, any _ nutritional supplement, or herbal treatment, for the purpose of providing medically assisted weight loss. il 39. Phentermine is a medication used for the purpose of enhancing weight loss; and, therefore Respondent, upon prescribing Phentermine to Patient H.Y., became subject to complying with the guidelines and standards for the appropriate prescribing of obesity drugs, as provided under Rule 64B8-9.012, Florida Administrative Code. 40. Respondent did not appropriately prescribe Phentermine to Patient H.Y., by his failure to follow the guidelines and standards set forth under Rule 64B8-9.012, Florida Administrative Code, as follows: a) Respondent did not determine and/or validate the BMI of Patient H.Y. in order to justify the use of Phentermine; b) Respondent did not conduct an initial evaluation of Patient H.Y. to include an appropriate physical and complete history; c) Respondent did not order appropriate tests related to medical treatment for weight loss, or appropriate referrals as indicated by the physical, history, and testing; d) Respondent did not prescribe Phentermine by a written and signed prescription, but rather by an_ internet transaction; 12 e) Respondent did not personally meet with Patient H.Y. and personally obtain an appropriate written informed consent from Patient H.Y. concerning weight loss treatments and potential benefits versus potential risks of weight loss treatments; and/or f) Respondent did not assure that Patient H.Y. undergo an in-person re-evaluation within 2 to 4 weeks of receiving the Phentermine, or a re-evaluation at least once every three (3) months thereafter. 41. Based on the foregoing, Respondent violated Section 458.331(1)(q), Florida Statutes (2002), 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, by virtue of inappropriately prescribing Phentermine to Patient H.Y., in violation of those specific guidelines and standards for the prescription of obesity drugs, as required under Rule 64B8-9.012, Florida Administrative Code. 13 COUNT IV — VIOLATION OF BOARD RULES 42. Petitioner realleges and incorporates paragraphs one (1) through twenty-five (25) as if fully set forth herein this Count Four. 43. Section 458.331(1)(nn), Florida Statutes (2002), provides that a physician may be subject to discipline for violating any provision of Chapter 458 or Chapter 456, Florida Statutes, or any rules adopted pursuant thereto. 44. Respondent failed to maintain any medical records reflecting his course of action, including Patient H.Y.’s medical history, examinations, tests administered and their results, consultations, diagnosis and/or treatment plan prior to prescribing an obesity medication, Phentermine to Patient H.Y. 45. Based on the foregoing, Respondent violated Section 458.331(1)(nn), Florida Statutes (2002), by violating Rules 64B8-9.003 and/or 64B8-9.012 FAC. WHEREFORE, Petitioner respectfully requests 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 14 Respondent’s practice, imposition of an administrative fine, issuance of a reprimand, placement of Respondent on probation, and/or any other relief that the Board deems appropriate. # SIGNED this YY day of. 2004. John O. Agwunobi, M.D., M.B.A. Secretary, Department of Health Oy wal, Lynne A. Quiynby-Pénnock Assistant General Counsel Prosecution Services Unit DATE Q 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Florida Bar No. 0394572 (850) 414-8126 (850) 488-1989 Fax FILED DEPARTMENT OF HEALTH DEPUTY CLERK SLERK laqp Reviewed and approved by: -27*- (initials) thos (date) PCP: march 26, 2004 PCP Members: El-Bahri, Vijayanagar Mark Sachs, M.D., DOH Case # 2002-22900 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 15 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. 16

Docket for Case No: 04-002026PL