03-000710PL Department Of Health, Board Of Medicine vs. Anthony Picchiello, M.D. Status: Closed Recommended Order on Thursday, August 7, 2003.

Summary: Respondent violated the standard of practice by prescribing a legend drug without patient contact.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 03 - 0710PL

)

ANTHONY PICCHIELLO, M.D., )

)

Respondent. )

)

RECOMMEND ED 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 Ro om, 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

R espondent 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 presentat ion 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 l imited 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 prescri bing 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 stateme nts 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 pa rties 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 w itness, 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 or ders. 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 numb er 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. O ver 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 Pat ient 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 th e 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 agen ts

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 prescript ion 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 Viag ra 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 i s 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 w as 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. comple ted 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 phys ician 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 KWIK MED

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 pr actice.

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 po tential

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 lea rned 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 Via gra 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) con cerning 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

th e 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

pre scribing 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 Kwik Med, 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 f orms 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 t he 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 t o 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 for m 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

Vi agra 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

loc ated 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 p erson

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

take n, 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 ex amining 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 Re spondent. 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 pati ent'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 - physi cian 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 Responde nt 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 quest ionnaire.

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 sufficie nt.

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 inte ractive 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.

* * *

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 informatio n (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 or der 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 .

Ÿ I am permitted by law to receive these

products in my region/country/locale.

Ÿ I understand the side - effects of this drug.

Ÿ I do not have a current prescription for

Viagra from another physician.

* * *

I certify that I wil l 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?

Ÿ Nitroglycerin Ÿ Nitrek Ÿ Nitro - Bid

(transdermal)

Ÿ Nitrodisc Ÿ Nitro - Dur Ÿ Nitrogard

Ÿ Nitroglyn Ÿ Nitrolingual Ÿ Nitrol

Spray Ointment

(Apoll - Kit)

Ÿ Nitrong Ÿ Nitro - Par Ÿ Nitr ostar

Ÿ Nitro - Time Ÿ Transderm - Nitro Ÿ Isosorbide

Mononitrate

Ÿ Imdur Ÿ Ismo Ÿ Monoket

Ÿ Isosorbide Dinitrate Ÿ Dilarate - SR

Ÿ Isordil Ÿ Sorbitrate Ÿ Erythatyl

Tetranitrate

Ÿ Pentaerythritol Ÿ Sodium

Tetranitrate Nitroprusside

Do you have any of the following medical

problems?

Ÿ Coronary Artery Ÿ Congestive Heart

Disease Failure

Ÿ Valvular Heart Ÿ Anat omic Deformation

Disease of the Penis

Ÿ Peyronie's Disease Ÿ Multiple Myeloma

Ÿ Obesity Ÿ Hypertension Ÿ Diabetes

Mellitus

Ÿ Prostate Cancer Ÿ Enlarged Prostate

Ÿ Low Testosterone Ÿ Thyroid Dis ease

Ÿ Atherosclerosis Ÿ Liver Disease

Ÿ Kidney Disease Ÿ Stroke Ÿ Depression

Ÿ Anxiety Ÿ Schizophrenia Ÿ Spinal Cord

Injury

Ÿ Endocrine Disorders Ÿ Sickle Cell Anemia

Ÿ Leukemia

Have you h ad 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 cigar s 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 ou r 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/d octor 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

questionnair e. 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 me dications.

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. physic ians 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 PHYSIC IAN 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 physici ans, 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 phy sical 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 hereb y 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

med ications. 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:

Th ank 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 instruct ions 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 condit ion, 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 KwikM ed'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 d octor

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 sugges tion 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 Int ernet 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 th at 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 informat ion 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 i n 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 docume nt 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 exp ert 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 par t 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 coul d 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 an d 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 int eractions 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

decli nes 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 proble ms

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 condit ion.

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

c ertain 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

bl ood 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 gai ned 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 med ication.

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 ere ctile

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 wh o 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 specialt y 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

bet ween 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 que stionnaire

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. Thi s 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

betw een 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 t he 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 pr oblem 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 prescribin g.

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

t he 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,

th e 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 Respon dent 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 usi ng 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 hemorrh age,

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

de cision 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

encount er, 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 establis hed 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 med icine, 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

con sultation 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

tes timony 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 havi ng 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 RESPOND ENT

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

prescrib es 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 prescr ibing 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

informati on 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 offerin g 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 nitr oglycerine.

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 p ressure

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 ans wers

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, i ndicating 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 o f 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 prescr ibe 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 questionnair e. 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 obtai ned

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 r oom 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. Depend ing 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 prescrip tion

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 tha t 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 per suasive 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 opp ortunity 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 in stitute 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 no rmal 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 t he 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 treat ment 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 t aken. 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 reliev e 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 ob ligated 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 e nvisioned

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 allegatio n 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:

A. Failing to perform the physical

exam ination on Patient J.R. prior to

prescribing Viagra;

B. Failing to obtain a complete history on

Patient J.R. prior to prescribing Viagra; and

C. 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 c onditions 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 t hat

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 al leged.

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 his tory 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;

examinatio n 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 phy sician 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

depa rtment 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 f or 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 Responden t 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

Tallahasse e, 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 Admi nistrative 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, Sui te 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, Flo rida 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.