STATE OF FLORIDA ena SIT DEPARTMENT OF HEALTH a DEPARTMENT OF HEALTH, PETITIONER, v. CASE NO. 2003-25274 HERBERT PARDELL, D.O., { \ C| us 74h 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 Osteopathic Medicine against Respondent, Herbert Pardell, D.O., and in support thereof alleges: 1. Petitioner is the state department charged with regulating the practice of osteopathic medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes, and Chapter 459, Florida Statutes. 2. Atall times material to this Complaint, Respondent was a licensed osteopathic physician within the state of Florida, having been issued license number OS 2368. j 3. Respondent's address of record is Emerald Hills Medical Center, 4330 Sheridan Street, Suite 102, Hollywood, Florida 33021. 4, Respondent is board certified in internal medicine. 5. On or about October 8, 2003, by way of an internet transaction, Respondent prescribed a legend drug (Ambien) to Patient D.P. 6. At the time of the internet transaction with PrivacyRx, Patient D.P. was residing in North Carolina. 7. While on-line, Patient D.P. requested Ambien and placed his order by completing an on-line order form, which was forwarded to the Respondent. 8. | The order form for Ambien that was completed by Patient D.P. consisted of approximately eighteen (18) generalized questions. 9. Those questions, propounded to or answered by Patient D.P. within the pretext of an on-line medical consultation, did not sufficiently provide a full and verified, or verifiable, set of information, including patient history, physical examination results, laboratory results, hospitalizations, or other relevant medical WwW information for the proper and appropriate prescribing of Ambien to Patient D.P. 10. Upon Respondent's receipt of Patient D.P’s order form, Respondent prescribed 30 units of Ambien 5 mg for Patient D.P. 11. Ambien is the trade name for a prescription drug containing the active ingredient zolpidem. Zolpidem is in a class of drugs called sedative/hypnotics or sleep medications. Zolpidem affects chemicals in your brain that may become unbalanced and cause insomnia. 12. Zolpidem induces sleep and causes relaxation. It is used to treat sleep disorders such as trouble falling asleep, waking up many times during the night, or waking up too early in the morning. 13. Zolpidem is for short-term use only, usually for seven to ten days. Longer-term use must be monitored closely by a physician. 15. Respondent is an osteopathic physician who prescribes and orders prescription medications to individuals over the internet. 16. | Respondent did not conduct an in-person consultation with Patient D.P. prior to prescribing Ambien. Lvs) 17. Respondent did not independently verify and/or substantiate the information contained within the order form allegedly completed by Patient D.P. prior to prescribing Ambien. 18. Respondent relied solely on the information contained within the order form for prescribing Ambien to Patient D.P. 19. | Respondent did not conduct a physical examination of Patient D.P. prior to prescribing Ambien. 20. Respondent did not determine and/or verify any potential contraindications in Patient D.P. prior to prescribing Ambien. 21. Respondent did not provide any plan of care, follow-up care, or monitoring prior to, or at any time following, his prescribing of Ambien to Patient D.P. 22. Respondent's medical records, relative to having prescribed Ambien to Patient D.P,, consisted only of the internet prescription order form. 23. Medical records relative to Respondent having prescribed Ambien to Patient D.P,, did not justify the course of treatment Respondent provided to Patient D.P. 24. | Respondent inappropriately prescribed Ambien to Patient D.P., by virtue of having prescribed such medication to Patient D.P. based solely on an internet transaction and on-line order form. 25. Respondent failed to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances, when he prescribed Ambien to Patient D.P.,, based solely on an internet transaction and on-line order form. COUNT ONE 26. Petitioner realleges and incorporates paragraphs one (1) through twenty five (25) as if fully set forth herein. 27. Section 459.015(1)(x), Florida Statutes (2003), provides that an osteopathic physician may be subject to discipline by the Board of Osteopathic Medicine for failing to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances. Wh 28. Rule 64B15-14.008(1), Florida Administrative Code (F.A.C.), provides that prescribing medications based solely on an electronic medical questionnaire constitutes the failure to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonable prudent osteopathic physician as being acceptable under similar conditions and circumstances, as well as prescribing legend drugs other than in the course of an osteopathic physician’s professional practice. Such practice shall constitute grounds for disciplinary action pursuant to Sections 459.015(1)(x) and (t), Florida Statutes. 29. Rule 64B15-14.008(2)(a)-(c), F.A.C., provides that osteopathic physicians shall not provide treatment recommendations, including issuing a prescription, via electronic or other means, unless the following elements have been met: (a) A documented patient evaluation, including history and physical examination, adequate to establish the diagnosis for which any drug is prescribed; (b) Sufficient dialogue between the osteopathic physician and the patient regarding treatment options and the risks and benefits of treatment, and (c) Maintenance of contemporaneous medical records meeting the requirements of Rule 64B15-15.004, F.A.C. 30. During Respondent's care of Patient D.P., Respondent failed to practice osteopathic medicine with the requisite level of care, skill, and treatment, in the following ways: a) Respondent failed to establish a doctor-patient relationship with Patient D.P.; b) | Respondent failed to perform a physical examination of Patient D.P.; c) Respondent failed to verify Patient D.P.’s medical information; d) | Respondent failed to verify Patient D.P.’s need for Ambien; e) Respondent failed to verify Patient D.P.’s vital signs, such as height, weight, and blood pressure; f) Respondent failed to establish a plan of care for Patient D.P.; g) Respondent failed to order any laboratory analysis for Patient D.P.; and h) Respondent failed to discuss the benefits and risks associated with the taking of Ambein with Patient D.P. 31. Based upon the foregoing, Respondent has violated Section 459.015(1)(x), Florida Statutes (2003), by and through a violation of Rule 64B15-14.008, F.A.C., by failing to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances. COUNT TWO 32. Petitioner realleges and incorporates paragraphs one (1) through twenty five (25) as if fully set forth herein. 33, Section 459.015(1)(0), Florida Statutes (2003), provides that an osteopathic physician may be subject to discipline by the Board of Osteopathic Medicine for failing to keep legible medical records that justify the course of treatment of the patient. 34. Rule 64B15-15.004, F.A.C., sets forth the minimum content requirement for osteopathic physicians’ medical records. Specifically Rule 64B15-15.004(1)(a)-(f), F.A.C., requires osteopathic physicians to maintain written legible records on each patient and at a minimum those records shall contain the following: patient histories; examination results; test results; records of drugs prescribed, dispensed or administered; reports of consultations; ‘and reports of hospitalization. 35. | Respondent's medical records regarding Patient D.P. insufficiently documented and did not justify the course of treatment of Patient D.P. 36. Respondent's records did_not include, without limitation, the following: a) | Assessments and/or related reports for planning the care of Patient D.P,, or for continuity in the evaluation of the condition and/or treatment of Patient D.P.; b) The name of Patient D.P’s primary physician, c) Verification or substantiation of Patient D.P.s medical condition and/or vital signs; d) Physical and/or medical examination results and Patient D.P’s medical history; or e) — Reports of consultations and/or hospitalizations. 37. Based upon the foregoing, Respondent has violated Section 459.015(1)(0), Florida Statutes (2003), and Rule 64B15- 15.004(1), FA.C., by failing to keep legible medical records that justify the course of treatment of the patient and that contain the minimum necessary information required by Board rule for the patient listed above. COUNT THREE 38. Petitioner realleges and incorporates paragraphs one (1) through twenty five (25) as if fully set forth herein. 39. Section 459.015(1)(t), Florida Statutes (2003), provides that an osteopathic physician may be subject to discipline by the Board of Osteopathic Medicine for prescribing, dispensing, administering, supplying, selling, giving, mixing, or otherwise preparing a legend drug, including controlled substances, other than in the course of the osteopathic physician's professional practice. 40. Rule 64B15-14.008(1), F.A.C., provides that prescribing medications based solely on an electronic medical questionnaire constitutes the failure to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonabie prudent osteopathic physician as being acceptable under similar conditions and circumstances, as well as prescribing legend drugs other than in the course of an osteopathic physician's professional practice. Such practice shall constitute grounds for disciplinary action pursuant to Sections 459.015(1)(x) and (t), Florida Statutes. 41. Respondent prescribed Ambien over the internet to Patient D.P. 42. Respondent's prescribing of Ambien to Patient D.P. was based solely upon information contained within an online medical questionnaire submitted by Patient D.P. through the internet. 43. Based upon the foregoing, Respondent has violated Section 459.015(1)(t), Florida Statutes (2003), by and through a violation of Rule 64B15-14.008, F.A.C., by prescribing, dispensing, administering, supplying, selling, giving, mixing, or otherwise preparing a legend drug, including controlled substances, other than in the course of the osteopathic physician’s professional practice. WHEREFORE, Petitioner respectfully requests that the Board of Osteopathic Medicine enter an order imposing one or more of the following penalties: , permanent revocation ofr 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 coliected, remedial education, and/or any other relief that the Board deems appropriate. SIGNED this oS day of 2377 Z VY _, 2004. John O. Agwunobi, M.D., M.B.A. Secretary, Department of Health FILED DEPARTMENT OF HEALTH, DEPUTY CLERK CLERK DATE - rK. Carden Assistant General Counsel DOH Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265 Florida Bar # 230560 (850) 414-8126 (850) 414-1991 FAX MKC/sw Reviewed and approved by: DEK (initials) Z / Se ¥ (date) DOH v. Herbert Pardell, D.O.; DOH Case No. 2003-25274 12 PCP: Sapte Fe 22, 2007 PCP Members: s/e-~~ ¥ Fy esiglore DOH v. Herbert Pardell, D.O.; DOH Case No. 2003-25274 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.

Docket for Case No: 04-004572PL