STATE OF FLORIDA DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF MEDICINE,

Petitioner,

vs.

ANTHONY PICCHIELLO, M.D.,

Respondent.

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) Case No. 03-0710PL

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RECOMMENDED ORDER

Notice was provided and on May 8, 2003, a formal hearing was held in this case. Authority for conducting the hearing is set forth in Sections 120.569 and 120.57(1), Florida Statutes. The hearing location was the Utilities Commission, DeBerry Room, 200 Canal Street, New Smyrna Beach, Florida. The hearing was conducted by Charles C. Adams, Administrative Law Judge.

APPEARANCES

For Petitioner: James W. Earl, Esquire

Department of Health

4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265

For Respondent: A. S. Weekley, Jr., M.D., Esquire

Holland & Knight, L.L.P.

400 North Ashley Drive, Suite 2300 Tampa, Florida 33602

STATEMENT OF THE ISSUE

Should Petitioner impose discipline on Respondent's license to practice medicine in Florida?

PRELIMINARY STATEMENT

On January 14, 2003, the Department of Health charged Respondent by an Administrative Complaint, Case No. 2001-04824, in two counts. Count one alleged a violation of Section 458.331(1)(t), Florida Statutes (2000), pertaining to the standard of care for practicing medicine. Count two charged Respondent with a violation of Rule 64B8-9.003, Florida Administrative Code, pertaining to the maintenance of medical records.1/ Given the option, Respondent elected to dispute the allegations of fact in the Administrative Complaint pursuant to Section 120.57(1), Florida Statutes. That choice was made known on February 7, 2003. On February 27, 2003, the case was received by the Division of Administrative Hearings. The case was noticed for hearing and heard on the date described.

Petitioner moved to allow the presentation of the testimony of Patient J.R., the subject of the Administrative Complaint, by telephone, to be offered during the final hearing. This request was made in recognition that the patient resides in Texas.

Respondent filed in opposition to the motion. The motion was granted upon condition that J.R. provide an oath before giving his testimony, such oath administered by an official in Texas

allowed to identify the witness, swear the witness in and confirm that process in writing to be filed later. The witness, J.R., was presented by telephone during the final hearing. The certificate by a notary public at large in Texas, Lisa Robin, verifying the identification of J.R. and the provision of the oath has been filed.

Respondent moved to change the venue of the hearing from New Smyrna Beach to Tampa. Petitioner opposed the motion. The motion was denied.

Petitioner moved to quash the subpoena duces tecum issued to Dr. Craig Lichtblau. Respondent opposed the motion. An order was entered requiring Dr. Lichtblau, pursuant to the subpoena duces tecum, to produce two patient's records in which Viagra had been prescribed with the identifying information describing the patients in any manner redacted. Dr. Lichtblau did not comply with the subpoena in its limited form. Notwithstanding the failure to comply, having heard Dr. Lichtblau's explanation for not complying and being persuaded that the parties through counsel had a reasonable opportunity to inquire of Dr. Lichtblau concerning his practice in prescribing Viagra for his patients without resort to those records, Dr. Lichtblau's testimony at hearing is accepted.

Consistent with prehearing instructions, the parties filed a Joint Prehearing Stipulation. Contained within that stipulation are statements of facts, which are admitted by the parties.

Those admitted facts, together with respective responses to requests for admissions in which the parties admitted certain facts, will be set forth in the findings of fact to this recommended order.

The parties agreed to official recognition of Rule 64B8- 8.001, Florida Administrative Code, Disciplinary Guidelines for the Board of Medicine.

Respondent sought official recognition of Chapter 64B8-36, Florida Administrative Code, associated with the licensure of pharmacist practicing in Florida. That motion was opposed. The motion was denied. A copy of that chapter submitted for official recognition is included with the record forwarded to the Board of Medicine.

In addition to the testimony of Patient J.R. taken by telephone, during the hearing Petitioner presented Craig H. Lichtblau, M.D., as its witness.

Respondent testified in his own behalf. He presented the testimony of Lee A. Fischer, M.D. over objection. Objection was also made to Respondent's witness, Miles J. Jones, M.D.'s, testifying. That objection was sustained. Counsel for

Respondent was allowed to present a basic proffer of the testimony to be elicited had Dr. Jones been allowed to testify.

Joint Exhibit 1 was admitted. Ruling was reserved on the admission of Petitioner's Composite Exhibit 1. That exhibit is admitted, having compared the exhibit to a similar exhibit set sworn to by the witness J.R. and filed in the case. Both Petitioner's Exhibit 1 and the sworn copy are submitted with the record, together with the certificate of provision of the witness oath to J.R. as certified by the notary public. Petitioner's Exhibits 2 through 4 were admitted.

Respondent's Exhibits 1, 3 and 7 were admitted. Respondent's Exhibits 2 and 4A were denied admission. Respondent's Exhibit 8 was identified but not offered. Those exhibits denied admission and not offered are submitted with the record in addition to the exhibits admitted.

The hearing transcript was filed on June 16, 2003. It was requested that the parties be granted more than 10 days from the filing of the transcript within which time post-hearing submissions could be filed. That request was granted which allowed the parties until June 30, 2003, to submit proposed recommended orders. Proposed recommended orders were timely filed. Under these arrangements the requirement that the recommended order be entered within 30 days of receipt of the

transcript was waived. Rule 28-106.216, Florida Administrative Code.

FINDINGS OF FACT STIPULATED FACTS: PREHEARING STATEMENT

1. The Department of Health is the state agency charged with regulating the practice of medicine under Florida law.

2. Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 458, Florida Statutes.

3. At all times material to the Administrative Complaint, Respondent was a licensed physician in the State of Florida, having been issued license number ME 0067232.

4. Respondent's address is New Smyrna Orthopedics, 600 Palmetto Street, New Smyrna Beach, Florida 32168.

5. On or around March 8, 2001, Patient J.R. completed a questionnaire through an internet site known as KwikMed.com.

6. Over the internet, Patient J.R. completed an Interactive Consultation Form and was prescribed Viagra by Respondent.

7. Respondent did not conduct a physical examination of Patient J.R. prior to prescribing Viagra.

8. Respondent had never met Patient J.R. prior to prescribing Viagra.

9. Viagra is a legend drug containing Sidenafil citrate, and is used for the treatment of erectile dysfunction.

   PETITIONER'S FACTS ADMITTED IN RESPONSE TO REQUEST FOR ADMISSIONS

   
   

10. J.R. is an employee of the Federation of State Medical Boards (FSMB).

11. J.R. voluntarily contacted KwikMed.com via the internet.

12. One purpose of J.R.'s contacting KwikMed.com via the internet was other than obtaining a prescription for Viagra for his own personal use.

13. J.R. has no personal professional training qualifying him to become licensed to practice medicine in any state.

14. J.R. completed, via the internet, the Interactive Consultation Form.

15. J.R. expected KwikMed.com, its employees and/or agents and/or other representatives to rely on the information that J.R. supplied via the internet.

16. The only question for which J.R. provided an inaccurate answer was, "I feel that I am incapable of having normal and satisfying sex without prescription medication"; thus, the Request for Admission is admitted to that extent, but otherwise denied.

17. J.R. received, via the internet, the supplementary material.

18. J.R. was reimbursed his out of pocket expenses for the purchase price of the Viagra obtained from KwikMed.com.

19. J.R. was compensated for the time that he utilized in contacting KwikMed.com to conduct the purchase of Viagra using the internet.

    RESPONDENT'S FACTS ADMITTED IN RESPONSE TO REQUEST FOR ADMISSIONS

    
    

20. 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.

21. At all times material to the Administrative Complaint Respondent was a licensed physician in the State of Florida, having been issued license number ME 0067232.

22. Respondent's address is New Smyrna Orthopedics, 600 Palmetto Street, New Smyrna Beach, Florida 32168.

23. On or about March 8, 2001, Patient J.R. completed a questionnaire through an internet site known as KwikMed.com.

24. Over the internet Patient J.R. completed an Interactive Consultation Form and was prescribed Viagra by Respondent.

25. The standard of care for prescribing Viagra requires the physician to make a diagnosis or treatment plan for the patient prior to prescribing Viagra.

26. Respondent did not conduct a physical examination of

    
    

    J.R. prior to prescribing Viagra.

    
    

27. Viagra is a legend drug containing Sildenafil citrate used for the treatment of erectile dysfunction.

    ADDITIONAL FACTS:

    RESPONDENT'S VIAGRA PRESCRIBING AND KWIKMED

    
    

28. Respondent specializes in physical medicine and rehabilitation and is board-certified in that specialty. He is a physiatrist.

29. As part of his practice Respondent prescribes Viagra.

    
    

    Some of the patients who have been prescribed Viagra have been seen in his office practice. In the past Respondent also prescribed Viagra through the use of the internet. That approach is not his current practice.

30. The Physicians Desk Reference (PDR) describes Viagra as "an oral therapy for erectile dysfunction." The PDR under its statement of precautions includes the remark, "the evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete assessment."

31. Respondent is received as an expert in physical medicine and rehabilitation and in the prescribing and use of Viagra.

32. Respondent had learned of Viagra before it was officially approved to be prescribed. When Viagra was made available Respondent was detailed by a pharmaceutical representative and researched the medication for use in his practice. Respondent's experience in prescribing Viagra has shown it to be successful in the majority of cases.

33. In the past Respondent has participated in CMEs on the treatment of an erectile dysfunction.

34. Respondent looked into information from the Food and Drug Administration (FDA) concerning the requirements for safe prescribing of Viagra. His impression of the information from the FDA was that the governmental agency was concerned about people prescribing medications that were not approved in the United States or not approved by the United States Pharmacy. Respondent was aware that Viagra was used in the United States, to include use by the United States Pharmacy.

35. Later, around January 2001, an acquaintance asked Respondent if he would be interested in prescribing Viagra over the internet. Respondent held to the belief that use of the internet for prescribing Viagra "was going on all over the place," including in Florida.

36. Respondent reviewed the regulatory statute in Florida and did not find an explicit prohibition against the use of the internet for prescribing. It is inferred that the regulatory

    statute that was reviewed by Respondent was Chapter 458, Florida Statutes. In essence, Respondent having found no specific prohibition against internet prescribing in his legal research of the regulatory statute, thought it was "O.K. to do."

37. Believing that Viagra was a very safe medicine and being persuaded that Viagra was being prescribed on the internet "all over the place," Respondent held to the view that his prescribing of Viagra on the internet would not be something that would be opposed by Petitioner because it was such a rampant practice, as he understood it.

38. In the interest of prescribing Viagra over the internet Respondent became affiliated with KwikMed, Inc., an internet provider offering Viagra over the internet with the assistance of physicians such as Respondent.

39. In August 2001 Respondent became aware that prescribing over the internet was an activity questioned by the Board of Medicine, so Respondent stopped prescribing on the internet. Before that time Respondent had been paid a stipend of $1500.00 per week from KwikMed, Inc. for his services.

40. Respondent was paid his stipend for being available during the week to review internet forms filled out by KwikMed customers and writing prescriptions where the information in the form persuaded Respondent that the prescriptions were justified.

41. By these arrangements Respondent had no fact-to-face contact with the person who completed the form seeking the prescription of Viagra. Respondent had no direct internet contact with the person. His participation with the person seeking Viagra trough KwikMed was without the knowledge of the person that Respondent was the physician reviewing the application referred to on the internet as an interactive consultation form.

42. Having no direct interaction with the patient for whom he prescribed Viagra, Respondent relied upon the veracity of the information provided by the applicant in response to the interactive consultation form. He relied upon the pharmacy insert provided with the medication prescribed to educate the user as to the use of the medication, side-effects, precautions, and drug interactions.

43. Respondent relied upon a form of consent to medical care contained in the interactive consultation form related to treatment of erectile dysfunction. Respondent was also aware of a part of that form described as a certification and warranty of the applicant as to the truthfulness of the answers to questions in the form provided by the applicant in the interest of supplying Viagra to the applicant.

44. Pertinent features of the interactive consultation form will be disclosed in these facts.

45. Because the interactive consultation form carried the certification and warranty of the applicant as to the truthfulness of the answers provided to the questionnaire contained within that form, Respondent felt that he could believe the patient. In this case, J.R. was the patient who obtained Viagra through the use of the KwikMed internet procedure leading to the prescribing of ten 50 milligram Viagra pills by Respondent.

46. Respondent does not perceive any difference between the prescribing of Viagra for J.R. over the internet, a patient located in Texas, while Respondent was located in Florida and the prescribing of Viagra for a patient seen by Respondent in his Florida office.

47. By contrast, the manner of prescribing Viagra in Respondent's office setting when the patient is seen in person begins with the patient's sign-in. There is verification of insurance, if any. The patient fills out a questionnaire that explains the reason for the visit and some general questions about medical history, to include what medications are being taken, what allergies have been experienced. Typically the patient would be brought to an examining room by one of the nurses on staff. Those personnel are usually responsible for recording the height and weight of the patient. When Respondent enters the examining room, he inquires about the patient's

    problem and asks him about his medications. Respondent inquires about the medical history of the patient in this face-to-face encounter. The information that has been provided by the patient is reviewed by Respondent. By inquiring, Respondent makes certain that the patient is not taking nitrates. Since the patient is in the room in his presence, Respondent may listen to the heart and lungs. In this visit the opportunity is provided to help increase the patient's understanding of the use of Viagra to address the patient's condition. If it is deemed appropriate the Respondent would then prescribe Viagra.

48. For purposes of the prescription of Viagra, Respondent expressed the opinion that the patient-physician relationship and its basis are a matter of trust and agreement. The physician trusts the patient to give information to the physician and there is an agreement that the information will be correct and something will be done. In that setting Respondent relies upon the information provided. In this case Respondent believes that he was entitled to rely upon the information provided by J.R. in completing the application on the internet. Respondent trusted that J.R. was truthful in filling out the questionnaire.

49. Concerning the establishment of a treatment plan borne out by medical records, in J.R.'s case Respondent indicated that

    J.R. was provided a prescription for Viagra based on information obtained over the internet and that basis was sufficient.

50. Concerning the diagnosis of J.R. through this process, Respondent believed the diagnosis took place when J.R. said it was true that "I feel that I am incapable of having normal satisfying sex without prescription medication."

51. The interactive consultation form as executed by J.R. states in pertinent part:

    Approved Viagra prescriptions are valid for your original order and will be KwikFillable THREE (3) additional times without any further consultation and processing fee.

    
    

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    There will be a $70.00 charge for this physician consultation and processing only if the doctor approves your use of Viagra. If you are not approved, there will be NO charge for the consultation and processing.

    
    

    Your personal information (strictly confidential):

    
    

    First Name: J. Last Name: R. ADDRESS:

    Apt/Suite:

    City: Forth Worth

    U.S.A. residents: Texas

    
    

    * * *

    
    

    Each prescription can be dispensed with up to 3 reorders for a maximum order of 4 prescriptions (120 pills).

    
    

    I Request the following pill prescription: 10 pills @ $10.50 ea, 50 mg. Dose ($105.00) All amounts are in US currency.

    
    

    * * *

    By submitting this consultation form:

    
    

    • I certify that I am 18 years of age or older.

      
      

    • I am permitted by law to receive these products in my region/country/locale.

      
      

    • I understand the side-effects of this drug.

      
      

    • I do not have a current prescription for Viagra from another physician.

      
      

      * * *

      
      

      I certify that I will answer all the questions truthfully.

      
      

      Medical History:

      
      

      Your Medical History informs us of any possible medical contraindications you may have to taking Viagra.

      
      

      This information would be required before any physician could treat you for any illness or condition.

      
      

      What is your height (in inches)? 72

      
      

      What is your current weight (in lbs)? 235 What is your month and year of birth? 05 1976 Sex? Male

      Are you taking any of the following?

      
      

    • Nitroglycerin  Nitrek  Nitro-Bid

      (transdermal)

    • Nitrodisc  Nitro-Dur  Nitrogard

      
      

      	Nitroglyn		Nitrolingual Spray		Nitrol Ointment
      	Nitrong		Nitro-Par		(Apoll-Kit) Nitrostar

      
      

    • Nitro-Time  Transderm-Nitro  Isosorbide

      Mononitrate

      
      

    • Imdur  Ismo  Monoket

      
      

    • Isosorbide Dinitrate  Dilarate-SR

      
      

    • Isordil  Sorbitrate  Erythatyl

      Tetranitrate

      
      

    • Pentaerythritol  Sodium Tetranitrate Nitroprusside

      
      

      Do you have any of the following medical problems?

      
      

    • Coronary Artery  Congestive Heart Disease Failure

      
      

    • Valvular Heart  Anatomic Deformation Disease of the Penis

      
      

    • Peyronie's Disease  Multiple Myeloma

      
      

    • Obesity  Hypertension  Diabetes

      Mellitus

      
      

    • Prostate Cancer  Enlarged Prostate

      
      

    • Low Testosterone  Thyroid Disease

      
      

    • Atherosclerosis  Liver Disease

      
      

    • Kidney Disease  Stroke  Depression

      
      

    • Anxiety  Schizophrenia  Spinal Cord

      Injury

      
      

    • Endocrine Disorders  Sickle Cell Anemia

      
      

    • Leukemia

      
      

      Have you had a complete physical exam with blood tests within the last year? yes

      
      

      Do you consume more than 2 servings a

      day of alcohol? No

      If Yes please explain:

      
      

      Do you smoke cigars or cigarettes? No

      
      

      What medications (if any) are you currently taking, and why? (none indicated)

      
      

      Sexual History:

      
      

      Please indicate on this form your current medical problems. It is the same information you would be asked if you visited our clinic or any other physician that specializes in sexual dysfunction. This and all the other information you have entered is encrypted and safe during transmission over the Internet.

      Once received by our physicians, it will be protected under patient/doctor privilege laws.

      
      

      In the following questions, the term "erectile dysfunction" means the inability to achieve or sustain an erection that is adequate for normal sexual activity.

      
      

      What is currently bothering you about your health? Nothing

      
      

      Are you unable to achieve and sustain an erection that is adequate for penetration until orgasm? No

      
      

      Have you ever been evaluated for erectile dysfunction?

      
      

      "I Feel that I am incapable of having normal satisfying sex without prescription medication." True

      
      

      * * *

      
      

      Because you order Viagra, we strongly recommend that you also add Vitality Max to this order. Vitality Max has been designed

      to be taken with Viagra and is designed to help supercharge the system for maximum results and improved health.

      (90 Capsules: $39.95)

      
      

      Another product that works great for Viagra users is Prostate Support, an outstanding formula that addresses prostate problems and helps you maintain a healthy, vital prostate. (60 Capsules: $24.95)

      
      

      * * *

      
      

      CERTIFICATION AND WARRANTY OF APPLICANT:

      
      

      I hereby certify and warrant that I am an adult and will carefully read and truthfully answer all of the questions in the following questionnaire. I further certify that I have completed this application with the purpose of employing the service of the KwikMed

      L.L.C. physician and that he will be relying on the truth and accuracy of my answers in determining whether I should have Viagra supplied to me.

      
      

      I further certify and affirm that I am aware of the potentially lethal side effects of Viagra if I have ingested or taken other medications that are contraindicted with use of Viagra. I certify truthfully that I have not been taking any such medications.

      
      

      I also understand that I will receive accurate instructions and printed materials along with my prescription from a KwikMed

      L.L.C. physician. If I have failed in any way to furnish the KwikMed L.L.C. physicians with my complete and accurate medical history I have therefore not fulfilled my legal obligation to properly inform the physicians. In addition, in the future if I become aware of any changes I realize that it is my legal responsibility to immediately notify the KwikMed L.L.C. physicians and cease all use of Viagra until further notification.

      I AGREE THAT ALL ON-LINE MEDICAL CONSULTATIONS, DIAGNOSES, AND TREATMENTS (INCLUDING PRESCRIPTIONS FOR THE TREATMENT OF ARTHRITIS) WILL BE DEEMED TO HAVE OCCURRED IN THE STATE WHERE THE PHYSICIAN IS PHYSICALLY LOCATED AND LICENSED TO PRACTICE MEDICINE.

      
      

      I hereby agree to the foregoing terms and certify that the information contained therein is correct.

      
      

      CONSENT TO MEDICAL CARE

      
      

      I hereby release KwikMed L.L.C., its employees, its physicians, dispensing pharmacies and all related persons from any and all liability whatsoever associated or connected with my participation in ordering Viagra to treat my erectile dysfunction.

      
      

      Erectile dysfunction may be a symptom of an underlying physical problem. The manufacturer and the physician at KwikMed

      L.L.C. recommend a physical examination and a blood work up by a doctor before taking Viagra. I understood that an on-line medical consultation will not include a physical examination. I hereby waive a physical examination at this time and agree to obtain a follow-up medical examination before taking Viagra.

      
      

      I also understand that under Federal law KwikMed L.L.C. is unable to accept returns or issue refunds for any orders of prescription medications. I agree to be responsible for all customs, tariffs, and taxes applicable to my country.

      
      

52. The prescription written by Respondent for J.R. was filled by Daytona People's Pharmacy in Daytona Beach, Florida. The medication was accompanied by an insert from the pharmacy describing the use of the medication, side effects, precautions,

    and drug interactions. The medication was also accompanied by information from KwikMed concerning the purchase by its customer

    J.R. wherein it was stated:

    
    

    Thank you for your order! We are proud to be your best online source for Celebrex, Propecia, Viagra and Xenical.

    
    

    We pride ourselves on delivering the best possible buying experience to you and all of our customers.

    
    

    Feel free to contact us at any time if you have questions regarding this or any other order by calling 1-877-KWIKMED.

    
    

    Once again, thank you for ordering at KwikMed.com. We value your business and will continue to offer the hottest prescription drugs in the world and outstanding service.

    
    

    To reorder, please go to: http://www.KwikMed.com.

    Sincerely, KWIKMED.COM

    Customer Support

    
    

53. It is noteworthy that the certification and warranty of the applicant in completing the on-line questionnaire in its reference to accurate instructions and printed materials concerning the use of Viagra was in practice limited to those materials provided by People's Pharmacy. The comment within that certification and warranty of the applicant reminding J.R. that in the event of changes in his condition, he was responsible to immediately notify the KwikMed, L.L.C. physicians and cease the

    use of Viagra was in keeping with the practice where contact was made between the KwikMed customer and KwikMed. Beyond that contact it is assumed that access to the customer information would be provided to Respondent or another physician with whom KwikMed was affiliated upon transmittal by KwikMed as intermediary. Again, there would be no direct communication between J.R. and Respondent or other physicians in KwikMed's employ.

54. The consent to medical care contemplated by the interactive consultation reminded J.R. that the manufacturer of Viagra and the physician at KwikMed, in this instance Respondent, recommended a physical examination and blood workup by a doctor before taking Viagra. This is taken to mean a physical examination and blood work by a doctor other than Respondent, given Respondent's remote participation in this arrangement.

55. Likewise, the insert provided by People's Pharmacy in its suggestion that J.R. report certain side effects that persist or worsen to J.R.'s doctor promptly did not by the terms of that instruction contemplate Respondent as being the doctor described.

56. Patient J.R. is in actuality a project coordinator for the Internet Clearing House as employee for the FSMB of the United States. Part of his duties involve making purchases of medications from websites and informing regulatory authorities in the state and federal government of the identity of persons

    involved in that activity. As such J.R. was the complainant in this case.

57. J.R. accessed the website in question by using the search engine of Alta Vista, typed-in the word Viagra and accessed a number of websites leading to KwikMed.com. He provided the information in the interactive form. His responses to the questions within the questionnaire were correct with the exception that the question "I feel that I am incapable of having normal satisfying sex without prescription medication" was answered as true when in fact it was not true. He ordered the Viagra on March 8, 2001, after completing the questionnaire. He received the ten 50mg pills in a bottle with the prescription from Daytona People's Pharmacy. J.R. received the pharmacy insert and information document from KwikMed along with the medication.

58. J.R. has never met Respondent. J.R. filled out the information on the questionnaire and clicked on a button on his computer to submit the information to KwikMed. J.R. received an E-mail that his order had been assigned a number and if approved what the cost would be for the purchase. Subsequently the prescription arrived with the accompanying written information other than from Respondent. The prescription bottle referenced Respondent as the prescribing physician. This was the first time that Respondent had been identified to the knowledge of J.R.

    EXPERT OPINION: AGAINST RESPONDENT

    
    

59. Craig Lichtblau, M.D. has been licensed in Florida since June 1989. He practices in North Palm Beach, Florida. Dr. Lichtblau is board-certified in physical medicine and rehabilitation. Dr. Lichtblau, like Respondent, is a physiatrist. He is a fellow of the American Academy of Disability, Evaluating Physicians. In this case Dr. Lichtblau was recognized as an expert in physical medicine and in rehabilitation and in the prescribing of Viagra.

60. Dr. Lichtblau understands that Viagra is an oral medication designed to help with sexual dysfunction, erectile dysfunction.

61. Dr. Lichtblau prescribes Viagra as part of his office practice. Dr. Lichtblau has never prescribed Viagra via the internet.

62. Dr. Lichtblau expressed the opinion that the standard for prescribing legend drugs, Viagra among them, is the same throughout the nation. There must be a doctor-patient relationship before prescribing.

63. Dr. Lichtblau was familiar with J.R.'s execution of the interactive consultation form provided by KwikMed seeking Viagra and the prescription written for J.R. by Respondent.

64. Dr. Lichtblau explains that erectile dysfunction is a secondary condition to some underlying cause. It is important to understand that cause when deciding to prescribe or not prescribe Viagra. An example of causes for erectile dysfunction in connection with the diagnosis could be peripheral vascular disease, which treatment might involve the use of nitrates. Nitrates in combination with Viagra could promote a stroke, cardiac arrest, myocardial infraction or cardiac arrythmia in that Viagra causes the blood pressure to drop and the patient to become hypotensive. In addition to the use of nitrates in the presence of cardiac disease, other contraindications noted by Dr. Lichtblau when considering the use of Viagra would include hepatic disease, kidney disease and prospective interactions with other medications taken together with Viagra.

65. In his experience some persons who do not need Viagra will try to obtain the medication. He has had 21-year-olds who ask for Viagra. That is what he considers recreational use. He declines to prescribe the drug for that age group. It is a violation of the standard of care for physicians if they prescribe in that setting. This points out the need to know with some certainty who the patient is by appearance, an opportunity unavailable to Respondent in his choice to prescribe to J.R. without ever having seen him.

66. Prior to prescribing Viagra to a new patient,

    
    

    Dr. Lichtblau believes that a reasonably prudent physician should conduct a physical examination. By such examination problems such as congestive heart failure, cardiac arrythmia, hypotension and hypertension can be detected. The physical examination helps in coming up with an appropriate assessment and treatment plan and deciding whether the prescribing of the medication is a safe choice or not. The mere act of prescribing Viagra does not constitute a diagnosis or treatment plan, according to

    Dr. Lichtblau.

    
    

67. Some patients are confronted with events and do not understand their meaning when describing the medical condition. Shortness of breath and sleeping with extra pillows may be an indication that the patient is suffering from congestive heart failure. Twinges of pain in the chest thought to be indigestion may be angina or a type of cardiac insufficiency. To make certain of the meaning of these symptoms a physical examination is necessary leading to a diagnosis and a decision on the safety of prescribing a certain medication, according to Dr. Lichtblau.

68. A minimal physical examination would be constituted of blood pressure, pulse, listening to the lungs to ascertain the peripheral vascular status of the patient in Dr. Lichtblau's opinion.

69. Dr. Lichtblau asserts that in establishing a treatment plan for the prescription of Viagra, resort would be made to the history and physical examination. In that setting the diagnosis would be erectile dysfunction secondary to an endocrine problem, a pain problem or a vascular problem, as examples. If appropriate, a certain number of Viagra pills would be prescribed and the patient would be seen again to ascertain whether there were any side effects or complications. In that event the options would be to stop the medication, decrease its frequency, or reduce the dosage in it potency.

70. The history and information gained in the physical examination should be documented, according to Dr. Lichtblau.

71. By determining the underlying cause of the erectile dysfunction, Dr. Lichtblau decides whether he or some other specialist should be responsible for prescribing the medication. For example, a person with a history of cardiac problems would be referred to a cardiologist to determine the propriety of prescribing Viagra. By contrast, a person who has undergone back surgery and is suffering chronic pain that caused the erectile dysfunction would be a person subject to evaluation by

    Dr. Lichtblau leading to the prescription of Viagra, given his specialty as a physiatrist.

72. In relation to the cardiac patient by example,

    
    

    Dr. Lichtblau refers to a 67-year-old man who has a little shortness of breath, is not on cardiac medication, who has rales at his bases and may have a little congestive heart failure. In that instance Dr. Lichtblau does not believe he is the proper physician to prescribe Viagra, given his specialty as a physiatrist.

73. Whatever the nature of the encounter between the physician and a patient there must be face-to-face contact to be considered as appropriately practicing medicine in

    Dr. Lichtblau's opinion. There was no face-to-face contact between Respondent and J.R. There was no physical examination. There was no documentation of the treatment. As Dr. Lichtblau describes the performance by Respondent, all these necessary activities were overlooked.

74. By responding to the interactive questionnaire concerning medical problems of many types, not enough was done to ascertain J.R.'s condition. As Dr. Lichtblau considers the matter, this act of filling out the information without more constitutes the public's looking after its own needs. This is a diagnosis without physician involvement through a doctor-patient relationship. The arrangement in which J.R. filled out the questionnaire on his own without being in the Respondent's presence is not a substitute for immediate physical presence

    between the doctor and patient. That personal contact is what constitutes a doctor-patient relationship which Dr. Lichtblau considers appropriate. What Respondent did falls below the standard of care according to Dr. Lichtblau.

75. To prescribe Viagra on the basis of the results of the completed questionnaire through the interactive consultation form violated the standard of care according to Dr. Lichtblau, who considers that choice to prescribe to be dangerous and totally inappropriate.

76. Dr. Lichtblau expresses the opinion that there were no medical records maintained by Respondent concerning patient J.R. sufficient to indicate a diagnosis and treatment plan.

77. The completion of the questionnaire by patient J.R., which by his answers points to a problem concerning the ability to have normal sex, without Respondent performing a physical examination, falls short of a doctor-patient relationship in Dr. Lichtblau's opinion. The completion of the form in his opinion was nothing more than self prescribing.

78. Dr. Lichtblau does not believe that an adequate medical history was obtained from patient J.R. In his view a medical history is created with the physician asks the patient for the patient to describe in his own words the problem, the reason for the visit with the doctor. The physician has a responsibility to evaluate the subjective complaint compared to the findings on

    physical examination according to Dr. Lichtblau. Failing an appropriate history and in the absence of a physical examination, the Respondent did not establish an adequate diagnosis for the patient J.R. and fell below the standard of care in

    Dr. Lichtblau's opinion. Likewise, Dr. Lichtblau believes that there was no treatment plan established within the standard of care when Respondent addressed J.R.'s condition. Ultimately, there was no justification for the prescribing of Viagra to J.R. in Dr. Lichtblau's opinion.

79. Dr. Lichtblau, in arriving at his understanding of the indications and contraindications for the use of Viagra, relied on the PDR as source material. Dr. Lichtblau is familiar with the emphasis in the PDR concerning Viagra and its potentiation of the hypotensive effects of nitrates and the PDR's precautions against the use of Viagra by patients who are using organic nitrates. Dr. Lichtblau also commented on the reference within the PDR to the post-marketing experience in relation to cardio- vascular events related to myocardial infarction, sudden cardiac death, ventricular arrythmia, cerebrovascular hemorrhage, transient ischemic attack and hypotension. All of these are matters of concern with patients having preexisting cardio- vascular factors. Remarks by Dr. Lichtblau in addressing the PDR are perceived to be his attempt to explain why it is a serious

    decision that a physician makes when prescribing Viagra for a patient.

80. Dr. Lichtblau distinguishes between the circumstances here where there had never been a doctor-patient relationship established in the first instance, meaning a face-to-face encounter, and the instance where a doctor covers for another physician on call when the principal physician is unavailable. The latter instance is one in which a substitute doctor is allowed to cover the case because the principal physician had already established a doctor-patient relationship. This temporary substitution in providing care is acceptable in

    Dr. Lichtblau's opinion.

    
    

81. Dr. Lichtblau does not believe that a sexual history inventory is necessary to meet the standard of care when treating an erectile dysfunction. It is merely a tool. What is essential is a good history, physical examination, diagnosis, assessment and treatment plan.

82. In the context of the overall testimony, when

    
    

    Dr. Lichtblau refers to Respondent's not practicing medicine, his testimony is perceived as indicating that Respondent was not practicing medicine in a manner that met the standard of care.

    Instead, Respondent was writing a prescription based upon information that the patient filled out in the interactive consultation form. Dr. Lichtblau further explains his remarks as

    to whether Respondent was practicing medicine by commenting, "It appears that he was practicing medicine, but he wasn't--he didn't do it right. He did it incorrectly." In that part of the testimony Dr. Lichtblau goes on to explain the need for a history, a physical examination and the need to see the patient to practice medicine appropriately.

83. Dr. Lichtblau was not impressed with the affirmative response by Patient J.R. concerning having a complete physical exam with blood test performed within the last year prior to completing the questionnaire. Dr. Lichtblau pointed out that conditions or diseases listed in the questionnaire could develop within a year.

    EXPERT OPINION: FOR RESPONDENT

    
    

84. Lee A. Fischer, M.D. is licensed in Florida. He practices in West Palm Beach, Florida, in family medicine. He is board-certified by the American Board of Family Practice. He is a fellow in the American Academy of Family Physicians. He prescribes Viagra for patients in his office practice. He does not prescribe via the internet.

85. Over objection, Dr. Fischer was received as an expert in the standard of care for primary care physicians in Florida, as a general matter and as expert in prescribing Viagra.

86. Dr. Fischer was familiar with the responses given by the Patient J.R. in completing the KwikMed interactive

    consultation form. Dr. Fischer perceived the purpose of the interactive consultation form as being the obtaining of information from the prospective person who is trying to get Viagra over the internet. In turn, that information would be screened by a physician to allow prescribing Viagra based upon the responses given. Dr. Fischer expressed the opinion that the person offering the responses was other than a patient at the time the questionnaire was completed.

87. Dr. Fischer was impressed with the extent to which the questionnaire inquired of the person filling out the information concerning the use of various forms of nitroglycerine.

    Dr. Fischer believes that a person taking nitroglycerine or having the possibility of taking nitroglycerine constitutes the major contraindication for the use of Viagra. In combination nitroglycerine and Viagra could cause a patient's blood pressure to go too low.

88. In considering the list of medical problems described in the interactive consultation form, Dr. Fischer expressed the opinion that other than a recent stroke none of the other health- related conditions are contraindications to the use of Viagra.

89. Dr. Fischer believes that the answers to the questionnaire constitute a sufficient statement of the patient's history within the standard of care for obtaining the history before prescribing Viagra. He also believes that the answers

    provide sufficient diagnosis of the condition of erectile dysfunction, justifying treatment with Viagra.

90. In his office practice Dr. Fischer sees a variety of episodic patients and chronically-ill patients. He has frequent occasion to prescribe Viagra, a few times a week either as refill prescriptions or for new patients. He has not had complications or adverse reactions to Viagra reported by his patients.

91. Dr. Fischer accepts the pharmacy insert provided with the medication to Patient J.R. as setting forth the proposed treatment where it lays out the use of the medication, its side effects, precautions and drug interactions.

92. Because J.R. accepted the certification and warranty as applicant in requesting a prescription for Viagra, indicating the careful reading and truthful answers to the questions in the interactive consultation form, Dr. Fischer believes that a prescribing physician would be entitled to rely on that representation by the applicant.

93. Given the extensive nature of the information provided in the answers to the questionnaire and his belief that a face- to-face visit with a patient in his office would not obtain as much information as recorded in the interactive consultation form, it was safe for Respondent to prescribe Viagra, according to Dr. Fischer. On the subject of a physical examination of J.R., Dr. Fischer indicated that he would not do a physical on

    the patient if he walked in the door, given what was described about J.R. in the responses to the questionnaire. On the other hand some physical examination is made of patients that present in Dr. Fischer's office practice. When the patient arrives at his office the name is provided, address and insurance information recorded and a brief medical history is obtained concerning major medical illnesses or medications being taken. The patient has his height and weight recorded by medical assistants and blood pressure is taken before the patient is placed in an examining room. When Dr. Fischer enters the examining room he inquires about heart disease and any form of heart trouble or stroke. He inquires about medications especially in relation to nitroglycerine. If the answers to those questions are "No," Dr. Fischer asks about the patient's sexual problems. Depending on the answer he would tell the patient whether the patient was a proper candidate for the prescription of Viagra. He would personally tell the patient how to take the drug. He would tell him the dose and then write the prescription. Again, assuming the patient was the age reported by J.R. in completing the interactive consultation form, a person in his 30s with no reported history of illness, Dr. Fischer would not listen to the heart and lungs of that patient. If he were 75 years old with reported medical problems, Dr. Fischer said he might listen to his heart and lungs.

94. Dr. Fischer believes that the answer provided within the questionnaire where Patient J.R. stated, "I feel that I am incapable of having normal satisfying sex without prescription medication," met the definition of erectile dysfunction medically treatable by the use of Viagra and the answer to the question constituted a diagnosis. In his opinion that diagnosis is followed by a treatment plan constituted of the pharmacy insert describing the use of Viagra, identified in that document as sildenafil-oral.

95. Dr. Fischer expressed the opinion that, in what he described as the interaction between Patient J.R. and Respondent, the overall standard of care for practice in Florida, both as to the necessary history and treatment was met.

    PERSUASIVE OPINION

    
    

96. When considering the respective opinions of the consultant experts, Dr. Lichtblau's views are more compelling. He properly established that Respondent failed to meet the standard of care for prescribing Viagra in that he did not obtain a history of the patient, perform a physical examination, make a diagnosis or offer a treatment plan prior to prescribing Viagra.

97. Dr. Lichtblau is persuasive in his opinion that lacking actual contact between J.R. and Respondent the necessary steps to prescribing Viagra were not accomplished. J.R. was left to his own devices in providing answers about himself to the

    questionnaire without the normal opportunity for the patient and physician to meet face-to-face and for the physician to take into account the history and inquire further if need be, consider the results of the physical examination, no matter how cursory, make certain of the diagnosis and institute a treatment plan based upon this personal interaction. Dr. Fischer's reliance upon the answers obtained in the completion of the questionnaire may form the basis of the history for purposes of discussion with the physician, but that discussion was not allowed by the procedure followed between Patient J.R. and Respondent where no contact was made between patient and physician. Dr. Fischer in his opinion that the answer to the inquiry within the questionnaire concerning the incapability of having normal sex without prescription medication as constituting a diagnosis, is as

    Dr. Lichtblau alluded to, nothing more than self-diagnosis condoned by Respondent in his participation in this venture where Respondent did not personally state his diagnosis for the benefit of the Patient J.R. Dr. Fischer suggests that the insert from the pharmacy concerning the use of Viagra constituted a treatment plan. That information was imparted by the pharmacy and as

    Dr. Lichtblau opined, Respondent never set forth a treatment plan in his own right.

98. The nature of this enterprise supported by Respondent was one in which he was paid $1500.00 by KwikMed, his employer, and the employer profited in its merchandizing of Viagra with his assistance, $70.00 for processing leading to the provision of pills at $10.50 each, for a total of $105.00. These arrangements known to Respondent were such that both KwikMed and Respondent recommended a physical examination and blood work be done by another doctor before the Viagra was taken. It was one in which the on-line medical consultation did not include the necessary physical examination. The fact that the consent to medical care within the interactive consultation contemplated a waiver of the physical examination does not relieve Respondent of performing that physical examination consistent with the standard of care. Nor does it permit Respondent in the interest of that agreement by Patient J.R. to defer to a follow-up medical examination performed by some other physician before J.R. took the Viagra. Fortunately, the circumstances here did not lead to an outcome harmful to Patient J.R. but it was a process engaged in by Respondent that had the potential to harm a person not immediately known to Respondent, when Respondent was obligated by the standard of care to become personally familiar with the patient.

    CONCLUSIONS OF LAW

    
    

99. The Division of Administrative Hearings has jurisdiction over the subject matter and the parties to this action in accordance with Sections 120.569 and 120.57(1), Florida Statutes, together with Section 456.073, Florida Statutes.

100. Section 458.331 (1), Florida Statutes, sets forth grounds for Petitioner to discipline Respondent for acts described. The penalties imposed for violation are as envisioned in Section 458.331(2), Florida Statutes, as it refers to Section 456.072(2), Florida Statutes.

101. By the Administrative Complaint Petitioner seeks to discipline Respondent's medical license by imposing penalties for violations of provisions within Section 458.331(1), Florida Statutes. To prove the allegations necessary to establish the violations set forth in the Administrative Complaint, that proof must be by clear and convincing evidence. Ferris v. Turlington,

     510 So. 2d 292 (Fla. 1987) and Department of Banking and Finance v. Osborne Stern and Company, 670 So. 2d 932 (Fla. 1996). The meaning of clear and convincing evidence is described in Slomowitz v. Walker, 429 So. 2d 797 (Fla. 4th DCA 1983).

102. This case involves an allegation the Respondent departed from the acceptable standard of care incumbent upon a physician practicing in Florida. In determining his compliance or non-compliance with the standard resort is made to the

     opinions of experts in the medical profession. Purvis v. Department of Professional Regulation, 461 So. 2d 134 (Fla. 1st DCA 1984).

103. Count one to the Administrative Complaint charges Respondent with the violation of Section 458.331 (1)(t), Florida Statutes, by:

     1. Failing to perform the physical examination on Patient J.R. prior to prescribing Viagra;

        
        

     2. Failing to obtain a complete history on Patient J.R. prior to prescribing Viagra; and

        
        

     3. Failing to make a diagnosis or treatment plan for Patient J.R. prior to prescribing Viagra.

     
     

104. Section 458.331(1)(t), Florida Statutes, in pertinent part states:

     (t) [T]he 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. The board shall give great weight to the provisions of s. 766.102 when enforcing this paragraph. . . . As used in this paragraph,

     . . . '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,' shall not be construed so as to require more than one instance, event, or act. Nothing in this paragraph shall be construed to require that a physician be incompetent to practice medicine in order to be disciplined pursuant to this paragraph.

105. Petitioner has proved by clear and convincing evidence that Respondent violated Section 458.331(1)(t), Florida Statutes, in the manner alleged.

106. Count two to the Administrative Complaint charges Respondent with failing to keep written medical records justifying the course of treatment of Patient J.R., in that his records do not reflect that Respondent recorded an adequate medical history on the patient nor do the records justify the treatment of Patient J.R. with Viagra. This is alleged to have violated Rule 64B8-9.003(3), Florida Administrative Code, which

     states:

     
     

     Rule 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.

     
     

     The terms of that rule are made applicable under Section 458.331(1)(m), Florida Statutes, which states:

     (m) 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.

     
     

107. Petitioner has proved by clear and convincing evidence that Respondent violated Section 458.331(1)(m), Florida Statutes, by failing to comply with Rule 64B-8.9003(3), Florida Administrative Code. Respondent kept no records as such that would comply with the requirements of law.

108. Discipline imposed for the violations is consistent with the guidelines in Rule 64B8-8.001, Florida Administrative Code. With that guidance a suspension of one year for the violation in Count one and a $2,500.00 fine for the violation in Count two are appropriate.

RECOMMENDATION

Upon consideration of the facts found and conclusions of law reached, it is

RECOMMENDED:

That a final order be entered which finds the Respondent in violation of Counts one and two, suspends his license for one

year and imposes a $2,500.00 fine to be paid within 90 days of the entry of the final order.

DONE AND ENTERED this 7th day of August, 2003, in Tallahassee, Leon County, Florida.

S

CHARLES C. ADAMS

Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488-9675 SUNCOM 278-9675

Fax Filing (850) 921-6847 www.doah.state.fl.us

Filed with the Clerk of the Division of Administrative Hearings this 7th day of August, 2003.

ENDNOTES

1/ Contained within the Administrative Complaint are paragraphs

21 and 22. Those paragraphs relate to the attempt by Petitioner to recover the costs of investigation and prosecution in accordance with Section 456.072(4), Florida Statutes. Those paragraphs were dismissed before the administrative law judge, pending any necessity to consider material disputes of fact concerning the amount of cost, should the Board of Medicine enter a final order finding Respondent in violation of any counts within the Administrative Complaint.

COPIES FURNISHED:

James W. Earl, Esquire Department of Health

4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265

A. S. Weekley, Jr., Esquire Holland & Knight, LLP

400 North Ashley Drive, Suite 2300 Tampa, Florida 33602

Larry McPherson, Executive Director Board of Medicine

Department of Health 4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

R. S. Power, Agency Clerk Department of Health

4052 Bald Cypress Way Tallahassee, Florida 32399-1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this recommended order. Any exceptions to this recommended order should be filed with the agency that will issue the final order in this case.

Docket for Case No: 03-000710PL

Orders for Case No: 03-000710PL