STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

AGENCY FOR HEALTH CARE ) ADMINISTRATION, BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) CASE NO. 91-2811

)

IRVING ROYCE, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a formal hearing was conducted in this case on August 24, 1993, and February 22, 24 and 25, 1994, in Miami, Florida, before Stuart M. Lerner, a duly designated Hearing Officer of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Michael K. Blazicek, Esquire

Kenneth J. Metzger, Esquire 1/

Agency for Health Care Administration 1940 North Monroe Street, Suite 60

Tallahassee, Florida 32399-0792

For Respondent: Joseph S. Geller, Esquire

Sheraton Design Center Office Plaza 1815 Griffin Road, Suite 403

Dania, Florida 33004 STATEMENT OF THE ISSUES

1. Whether Respondent committed the violations alleged in the Administrative Complaint?

   
   

2. If so, what disciplinary action should be taken against him?

PRELIMINARY STATEMENT

On March 6, 1991, the Department of Professional Regulation (subsequently renamed the Department of Business and Professional Regulation and hereinafter referred to as the "Department") issued a six-count Administrative Complaint against Respondent, a Florida-licensed medical doctor specializing in psychiatry, alleging that, in connection with his care and treatment of "Patient #1," C.R., Respondent violated: Count One- Section 458.331(1)(m), Florida Statutes, in that "Respondent's medical records of Patient #1 do not justify Respondent's failure to diagnose Patient #1's abusive and addictive personality; Respondent's medical records do not justify Respondent's inappropriate and excessive prescribing of controlled substances and other legend drugs,

especially Ketalar, over a ten (10) month period; Respondent's medical records failed to justify Respondent's failure to seek a consultation with another physician, and document said consultation [prior] to performing ECT 2/ on Patient #1; [and] Respondent's medical records fail to justify Respondent's inappropriate use of Ketalar (Ketamine) treatment concomitantly with ECT;" Count Two- Section 458.331(1)(q), Florida Statutes, "in that Respondent prescribed Plegine for Patient #1, when Respondent knew or had reason to have

known that said patient had a history of drug abuse; Respondent inappropriately prescribed Plegine concomitantly with Didrex, a CNS stimulant, for Patient #1; Respondent inappropriately administered Ketalar, in conjunction with ECT treatment; Respondent inappropriately and excessively prescribed the following controlled substances: Benzodiazepines, Barbiturates, Amphetamines, and Ketalar;" Count Three- Section 458.331(1)(t), Florida Statutes, "in that Respondent failed to diagnose Patient #1's addictive and abusive personality; Respondent inappropriately and excessively prescribed legend drugs, most of which were controlled substances, over a ten (10) month period to Patient #1, without proper justification; Respondent failed to acquire a consultation with another physician before ordering ECT for Patient #1; Respondent inappropriately administered ECT treatments in conjunction with Ketalar therapy; and Respondent utilized ECT treatments when they were not indicated;" Count Four- Section 458.325(2), Florida Statutes, and therefore Section 458.331(1)(x), Florida Statutes, in that "Respondent failed to have Patient #1's treatment record reviewed, and the proposed Electroconvulsive Therapy agreed to by another physician, not directly involved with Patient #1, before the electroconvulsive therapy was administered to Patient #1;" Count Five- Section 458.331(1)(v), Florida Statutes, in that "Respondent practiced outside his expertise by treating Patient #1's rectal fissure during the course of her psychiatric treatment;" and Count Six- Section 458.331(1)(u), Florida Statutes, in that "Respondent treated Patient #1's psychiatric condition with Ketalar (Ketamine) and utilized Ketalar (Ketamine) in conjunction with ECT treatments" without "first obtaining full, informed and written consent" from the patient.

Respondent denied the allegations of wrongdoing made against him in the Administrative Complaint and requested a formal hearing. On May 6, 1991, the Department referred the matter to the Division of Administrative Hearings for the assignment of a Hearing Officer to conduct the formal hearing Respondent had requested.

On June 21, 1991, Respondent filed a motion to dismiss "any allegation [in the Administrative Complaint] not relevant nor material to the use of Ketamine." According to the motion, a review of "the [transcript] of the Board of Medicine's Probable Cause Panel meeting where the Panel authorized the issuance of [the] Administrative Complaint" 3/ revealed that the "sole 'problem' found by the Probable Cause Panel, for which it authorized the issuance of the Administrative Complaint, centered around the use of Ketamine." On July 1, 1991, the Department filed a response in opposition to Respondent's motion to dismiss. In its response, the Department argued that the motion was untimely and, in any event, without merit. On July 8, 1991, the Hearing Officer issued an order dealing with the motion. The order provided, in part, as follows:

Contrary to the assertion made by Respondent in his motion, it is not "abundantly clear" from a reading of the transcript of the Probable Cause meeting that the instant Administrative Complaint "contains allegations and charges which were not contemplated by the Probable Cause Panel." The matter is one that is subject to reasonable dispute. Accordingly, Respondent's request that the Hearing Officer enter a prehearing order recommending the dismissal of

these assertedly uncontemplated allegations and charges is hereby DENIED. The parties, however, will be permitted at the final hearing in this cause to present evidence relating to the issues raised in Respondent's motion to dismiss and Petitioner's response to the motion and, following the presentation of such evidence, to offer additional argument in support of their respective positions on these issues. In the recommended order that he will issue after the close of the final hearing in this case, the Hearing Officer will address those issues raised in the foregoing pleadings that were litigated at hearing.

The final hearing in the instant case, which was originally scheduled for September 5, 1991, was continued on numerous occasions for a variety reasons, including Respondent's ill health, scheduling conflicts, the appearances of substitute counsel, and problems associated with Hurricane Andrew, among others, before commencing on August 24, 1993. At the hearing, the Department presented the live testimony of three witnesses: Roger Mittleman, M.D., the Associate Medical Examiner for Dade County, Florida, and a board-certified anatomic, clinical and forensic pathologist, who performed the autopsy on patient C.R.; Martin Rosenthal, M.D., a board certified psychiatrist; and Daniel Sprehe, M.D., another board certified psychiatrist. The Department also offered eight exhibits (Petitioner's Exhibits 1 through 8) into evidence, all of which, except for Petitioner's Exhibit 7, were admitted by the Hearing Officer. Among the Petitioner's exhibits received into evidence were the transcripts of the depositions of James Hillman, M.D., a board certified toxicologist, and Margaret Dellerson, a former detective with the North Miami Beach Police Department involved in the investigation of C.R.'s death, 4/ which were offered in lieu of the deponents' live testimony at hearing.

Respondent testified on his own behalf at hearing and presented the testimony of six other witnesses: Melvin Simonson, M.D., a board certified psychiatrist; Kenneth Lasseter, M.D., a board certified clinical pharmacologist; Norman Craythorne, M.D., a board certified anesthesiologist; Jacqueline Royce, Respondent's daughter; Carol Royce, Respondent's wife and office manager; and Debra Mash-Geller, 5/ Ph.D., an Associate Professor of Neurology and Cellular and Molecular Pharmacology at the University of Miami School of Medicine. 6/ In addition, Respondent offered 24 exhibits (Respondent's Exhibits 1 through 23 and 25) 7/ into evidence at hearing. He subsequently withdrew two of these exhibits (Respondent's Exhibits 2 and 14) prior to the conclusion of the hearing. With the exception of Respondent's Exhibit 22, the admissibility of which the Hearing Officer deferred ruling on until the issuance of his Recommended Order, 8/ the remaining exhibits Respondent offered into evidence at hearing (Respondent's Exhibit 1, 3 through 13, 15 through 21, 23 and 25) were admitted by the Hearing Officer. Among the Respondent's exhibits received into evidence were the transcripts of the depositions of David Ornstein, M.D., a board certified internist and gastroenterologist who treated patient C.R. in early 1985, and Lloyd Miller, M.D., a board certified psychiatrist, which were offered in lieu of the deponents' live testimony at hearing. 9/

Following the presentation of Respondent's case, the Department declined the opportunity to present rebuttal evidence and the evidentiary portion of the hearing was closed. Thereafter, the Hearing Officer, on the record, established a deadline for the filing of post-hearing submittals. The deadline set by the Hearing Officer was April 7, 1994. Ultimately, the deadline was extended to November 28, 1994.

On November 28, 1994, the Agency for Health Care Administration (hereinafter referred to as the "Agency") 10/ and Respondent filed proposed

recommended orders in the instant case. Both parties' recommended orders are in excess of 40 pages. 11/ Nonetheless, they have been considered in their entirety inasmuch as the Hearing Officer, at the request of the parties, has waived the page limit requirements of Rule 60Q-2.031(3), Florida Administrative Code.

The parties proposed recommended orders each contain, among other things, what are labelled as proposed "findings of fact." These proposed "findings of fact" are specifically addressed in the Appendix to this Recommended Order.

FINDINGS OF FACT

Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made:

The Parties

1. The Agency is a state government licensing and regulatory agency.

   
   

2. Respondent is now, and has been since 1962, a physician licensed to practice medicine in the State of Florida, holding license number ME 0010545.

   
   

3. He is also licensed to practice medicine in the States of New Jersey and New York.

   
   

4. From 1948 to 1952, Respondent attended the Chicago Medical School, from which he graduated with a M.D. degree.

   
   

5. From 1952 to 1953, he had a rotating internship in a Newark, New Jersey hospital.

   
   

6. After receiving his license to practice medicine in the State of New Jersey, Respondent started a general medical practice there.

   
   

7. He closed his practice in 1955 to begin training in his current primary specialty, psychiatry.

   
   

8. He received such training from 1955 to 1960. He trained at Essex County Hospital in Cedar Grove, New Jersey, the New Jersey State Diagnostic Center in Menlo Park, New Jersey, the Veterans Administration Hospital in Lyons, New Jersey, Mount Sinai Hospital in New York, New York, and the Neuropsychiatric Institute in Princeton, New Jersey.

   
   

9. From 1960 to 1971, Respondent had his own psychiatric practice in Woodcliff, New Jersey.

   
   

10. During the earlier portions of this period he also authored the following three articles which were published in the American Journal of Psychiatry: "Improving Insulin Therapy in Schizophrenia with Neostigmine" (May, 1961); "Improving Insulin Therapy with Calcium Gluconate" (February, 1962); and "Resistant Psychosis Treated Successfully by Indoklon" (February, 1962).

    
    

11. In 1971, Respondent moved his psychiatric practice to Florida, specifically 9145 Northwest 27th Avenue in Miami.

    
    

12. He practiced psychiatry at this location in Miami until the early 1980's.

13. In addition to his private practice, in 1972, Respondent was the Director of the Methadone and Alcohol Unit at Reed Memorial Hospital in Miami.

    
    

14. In October of 1973 and May of 1975, respectively, two articles that Respondent had written, "Rapid Treatment of Opiate Addiction" and "The Post- Opiate Syndrome," were published in the Florida Journal of Medicine.

    
    

15. Furthermore, from 1982 to 1984, he taught a "Fundamentals of Medical Science" course at Florida International University's Bay Vista Campus in North Miami, Florida.

    
    

16. From July of 1983 to April of 1984, Respondent was a staff psychiatrist at the Broward County Crisis Center in Pembroke Pines, Florida.

    
    

17. Since leaving the staff of the Broward County Crisis Center in April of 1984, Respondent has been practicing psychiatry and, to a lesser extent, family medicine at his office located at 17122 West Dixie Highway in North Miami Beach, Florida.

    
    

18. In addition to his private practice, since approximately 1991, Respondent has taught psychiatry courses at Nova Southeastern University in Miami.

    
    

19. Although he teaches and practices psychiatry, he is not board certified in this specialty.

    
    

    Respondent's Care and Treatment of Patient C.R. Overview

20. From on or about October 2, 1984, to on or about July 8, 1985, (hereinafter referred to as the "treatment period") Respondent provided medical care and treatment to patient C.R., a 35-year old overweight female with suicidal thoughts.

    
    

21. C.R. initially presented to Respondent with complaints of melancholia, irritability, nervousness and inability to control her weight.

    
    

22. She explained that in the recent past her boyfriend had shot himself to death in her presence, her mother had passed away, and she had to put two of her cats to sleep, which events had led her to attempt to commit suicide by cutting her wrists.

    
    

23. She further informed Respondent that she expected to die and join her dead boyfriend in the near future.

    
    

24. Respondent diagnosed C.R. as having agitated depression with neurotic, not psychotic, features. He also concluded that she was suffering from obesity.

    
    

25. Depression is a disorder with a predominant complaint of melancholia and depressed affect.

    
    

26. A patient with agitated depression has features of melancholia, superimposed with anger and irritability. Agitated depression is more difficult to treat clinically than simple depression.

27. During subsequent visits C.R. also complained of diarrhea, headaches, coughing spells, and pain associated with a fissure in her anal canal.

    
    

28. Although C.R. made certain comments to Respondent during the treatment period indicating that she used cocaine and consumed excessive amounts of alcohol, Respondent reasonably believed, based upon the totality of circumstances, including other statements C.R. made to him and her appearance, demeanor and conduct during her visits to his office, that C.R.'s claims of cocaine and excessive alcohol use were "attention-getting" fabrications and that she did not have an addictive or abusive personality or a history of drug or alcohol abuse 12/ and he treated her accordingly. In doing so, Respondent did not act in a manner that was inconsistent with what a reasonably prudent psychiatrist at the time would have done under similar circumstances.

    
    

29. In the medical records that he maintained on C.R., Respondent noted that C.R. had made claims of cocaine and excessive alcohol use, but he did not indicate that he disbelieved these claims.

    
    

30. C.R.'s condition gradually improved during the treatment period. She lost weight, maintained a neater and cleaner appearance and became more outgoing.

    
    

    Overall Drug Regimen

    
    

31. During the treatment period, Respondent prescribed the following legend drugs for C.R.: Plegine, which contains Phendimetrazine, a Schedule III controlled substance; Didrex, a Schedule III controlled substance; Sinequan; Elavil; Valium, which contains Diazepam, a Schedule IV controlled substance; Librium, which contains Chlordiazepoxide, a Schedule IV controlled substance; Xanax, which contains Alprazolam, a Schedule IV controlled substance; Inderal; Ativan, which contains Lorazepam, a Schedule IV controlled substance; Placidyl, which contains Ethchlovynol, a Schedule IV controlled substance; Hycodaphen, which contains Hydrocodone, a Schedule III controlled substance; Darvocet, which contains Propoxyphene, a Schedule IV controlled substance; Percocet, which contains Oxycodone, a Schedule II controlled substance; Percodan, which also contains Oxycodone; Sudafed; Gantrisin; Paregoric; and Xylocaine (in ointment form).

    
    

32. Respondent also administered the legend drug Lasix to C.R.

    
    

33. In addition, he administered to C.R. the following legend drugs as adjuncts to psychotherapy: Ketamine Hydrochloride (hereinafter referred to simply as "Ketamine"), which is sold under the brand name of Ketalar; Brevital, a barbiturate containing Methohexital, a Schedule IV controlled substance; and, on a single occasion, Seconal, another barbiturate, which contains Secobarbital, a Schedule II controlled substance.

    
    

34. He further administered to C.R. Brevital and the legend drugs Atropine and Anectine in conjunction with non-convulsive electric current therapy.

    
    

35. That Respondent prescribed or administered the legend drugs specified in the preceding four paragraphs is reflected in the medical records that Respondent maintained on C.R. Respondent further indicated in these medical records the amounts of these drugs that were prescribed and administered.

    
    

36. Respondent's polypharmacy approach to treat the symptom clusters with which C.R. presented (and which were noted in the medical records that

    Respondent maintained on C.R.) was not inappropriate and did not produce any significant, unwanted drug interactions. Furthermore, Respondent did not prescribe or administer any drugs to C.R. 13/ in excessive amounts and he carefully monitored C.R.'s use of the drugs that he prescribed for her during her frequent office visits.

    
    

    Antidepressant Drug Therapy

    
    

37. In the ordinary case, where time is not of the essence, a tricyclic antidepressant, such as Sinequan or Elavil, which Respondent prescribed for C.R. on her second visit on October 9, 1984, is the medication of choice in attempting to combat depression.

    
    

38. Sympathomimetic amines, such as Plegine and Didrex, are also used in treating depression. 14/ (In addition to helping fight depression, these amphetamine-like 15/ "mood elevators" also function as anorexic agents.)

    
    

39. Unlike tricyclic antidepressants, which produce no immediate effect, sympathomimetic amines are very rapid acting. Therefore, if a patient suffering from depression is suicidal and in the throes of a life threatening crisis, as was C.R. when she presented to Respondent, treatment with sympathomimetic amines is warranted because of the quick relief it provides.

    
    

40. Because of C.R.'s desperate situation, Respondent prescribed both Plegine and Didrex to treat her depression.

    
    

41. That these sympathomimetic amines might also help C.R. lose weight was, in Respondent's mind, an added bonus, but it was not the primary reason that he prescribed them.

    
    

42. Neither Plegine nor Didrex should be prescribed for an individual who has an addictive or abusive personality or a history of drug or alcohol abuse. Respondent, however, as noted above, reasonably believed that, in the case of C.R., he was not dealing with someone who had drug or alcohol problems.

    
    

43. While there were occasions that Respondent prescribed both Plegine and Didrex for C.R. on the same date, he never prescribed them for concomitant use.

    
    

44. When he gave C.R., during the same visit, prescriptions for both Plegine and Didrex, he specifically instructed her to use them, not at the same time, but rather sequentially, for minimum periods of a week each. That he gave these instructions, however, is not reflected in the medical records he maintained on C.R.

    
    

45. It is an acceptable practice to alternate the use of Plegine and Didrex in such a manner to determine which produces the best results for the patient.

    
    

46. Respondent found that Plegine was more effective than Didrex in combatting C.R.'s depression. He therefore stopped prescribing Didrex for C.R. The last time he prescribed Didrex for her was November 27, 1984.

    
    

47. He continued to prescribe Plegine until June 18, 1985.

    Antianxiety Drug Therapy

    
    

48. To reduce the anxiety that C.R. was experiencing, Respondent appropriately prescribed the benzodiazepines Valium and Xanax and other antianxiety agents and sedatives, including Inderal, which he prescribed after

    C.R. reported having a "panic attack," and Placidyl, a strong hypnotic sedative or sleeping pill.

    
    

49. These antianxiety agents were prescribed for concomitant use with antidepressant medication.

    
    

50. Such concomitant use is appropriate where the patient is both depressed and anxious, as was C.R. in the instant case.

    
    

    Drug-Assisted Psychotherapy

    
    

51. On approximately 40 separate occasions, from November 10, 1984, to June 11, 1985, Respondent administered Ketamine to C.R. intravenously prior to a psychotherapy session in order to reduce her resistance to psychotherapy. 16/

    
    

52. Ketamine is a commonly used, 17/ relatively safe, 18/ FDA-approved 19/ anesthetic that is structurally similar to PCP. 20/ It is a legend drug.

    
    

53. Unlike traditional anesthetics, which are general central nervous system depressants, Ketamine depresses some parts of the brain and stimulates others.

    
    

54. In sufficient dosage, it provides anesthesia quickly.

    
    

55. Its anesthetic effect lasts a relatively short period of time (approximately ten minutes) and there is generally rapid recovery, although postoperatively, some patients may hallucinate.

    
    

56. While Ketamine remains in the bloodstream for approximately 24 hours, a patient who has received an anesthetic dose of Ketamine 21/ and suffered no complications, as a general rule, may be released two hours after having been anesthesized, provided instructions are given that the patient is not to operate a motor vehicle or other dangerous machinery or to make any major decisions immediately upon the patient's release.

    
    

57. Aside from hallucinations, other possible side-effects from the use of Ketamine, according to the Physician's Desk Reference (hereinafter referred to as the "PDR"), include delirium, confusion, amnesia, tonic and clonic movements sometimes resembling seizures, anorexia, nausea and vomiting. Furthermore, because it tends to raise blood pressure, it should be used with caution where the patient is hypertensive. 22/ There is no evidence in the anesthesia literature that even the repeated use of Ketamine causes psychosis in normal patients.

    
    

58. The impact that Ketamine has on the psyche induces an abreactive or dissociative effect in the patient and results in the patient becoming more verbal and expressive. Furthermore, like all anesthetics, Ketamine can be used as a tranquillizer to allay anxiety if administered in a dosage and manner that does not achieve an anesthetic outcome. 23/ Because of these features, there is reason to believe that Ketamine may help as an adjunct to psychotherapy.

59. There are a number of authoritative, scientific articles, some dating as far back as the 1940's, which support such a view. Among them is a 1973 article, "The Use of Ketamine in Psychiatry," written by E. Khorramzadeh and

    A.O. Lofty (Respondent's Exhibit 11) and a 1979 article, "Ketamine-Facilitated Induced Anxiety Therapy and Its Effect upon Clients' Reactions to Stressful Situations," written by A.A. Sappington, G. Corssen, A.T. Becker and M. Tavakoli (Respondent's Exhibit 10). Respondent reviewed these two articles before deciding to use Ketamine as an adjunct to C.R.'s psychotherapy.

    
    

60. Notwithstanding the foregoing, Ketamine-assisted psychotherapy is not now, nor was it at any time material to the instant case, recognized as a standard or conventional treatment in the mainstream psychiatric community.

    
    

61. It is not even mentioned in either the PDR or the American Psychiatric Association's four volume work on the treatment of psychiatric disorders.

    
    

62. Furthermore, the FDA-approved labeling and package insert for Ketamine make no mention of the drug having any use in the practice of psychiatry.

    
    

63. It is not necessarily inappropriate, however, for a physician to use a drug that has been approved as safe by the FDA for a purpose other than that which is indicated on the FDA-approved label and package insert.

    
    

64. Before he used Ketamine in his treatment of C.R. as an adjunct to psychotherapy, Respondent discussed the matter with C.R. and obtained her full, informed written consent.

    
    

65. Such consent was given in a handwritten statement that C.R. signed on November 6, 1984. The statement, which Respondent retained as part of his medical records on C.R., read as follows:

    
    

    Permit to Dr. Royce

    I, [C.R.], have been suffering from painful depression and nervousness. I have learned that Pentothal and Amytal (AMYTAL) Interviews, also known as TRUTH SERUM, have helped persons with symptoms such as mine. Dr. Royce who has been using Amytal interviews since 1957, has also had experience with the same technique using ketamine, a much safer drug than Amytal

    or Pentothal. The effect of ketamine (also known as KETALAR), wears off in less than 15 to 20 minutes. Therefore, a patient is able to leave the doctor's office hours sooner than would be possible with Amytal. Ketamine is also safer because it does not depress the cough or gag

    reflexes or respiration, as Amytal and Pentothal do.

    
    

    Because of these facts, I am now writing this statement with Dr. Royce's help to give permission to IRVING D. ROYCE, M.D. to treat me with psycho- therapy including intra-venous injections of ketamine. I expect that the ketamine will help

    me to feel less depressed and less agitated, at least for the 10 to 15 minutes during which time it will have an effect on me. If I am less distracted by my physical nervousness and my

    depression, I will at least be able to participate better in therapy with Dr. Royce.

    
    

    Also Dr. Royce has discussed with me studies involving persons who have shown improvement during psychotherapy using ketamine at the start of the therapy sessions. Since Dr. Royce will be using lower doses than described in the Physicians

    Desk Reference ("P.D.R.") to help control my physical agitation I do not expect that these added psychiatric benefits will positively occur. However, if my psychotherapy should happen to show some benefit because of the ketamine, then I shall be grateful

    for that. In my mind there is a narrow line dividing whether or not I can expect to evolate (EVOLATE) in time to be with David Clark in Heaven for New Year's Eve. I doubt that my fate can be changed.

    
    

    I already have some first-hand knowledge of the value and safety of ketamine because I used it quite a few times to clip the claws of my cats.

    
    

    Dr.Royce and I have discussed alternate treatments for overcoming my expectation to be dead before the end of this year. He favors electroshock treatments in a hospital but I don't want to go through those seizures. We also discussed more frequent office visits and/or a higher dose of drugs for me, but

    I'd rather not change our pattern of having Dr. Royce evaluate my medications from one week to the next. We discuss how I feel each time and Dr.

    Royce adjusts the dose or changes medicines accordingly.

    
    

    I have told Dr. Royce that I expect to patch things up with David Clark as soon as I can get to him.

    I have to evolate (EVOLATE) as soon as possible to be with him before he returns to this life as some- body else. After his reincarnation (REINCARNATION), I may not be able to recognize who he really is.

    With or without any medication such as ketamine, I'm running out of time.

    
    

    The discussion of KETALAR in the P.D.R. says, "Ketalar has been studied in over 12,000 operative and diagnostic procedures, involving over 10,000 patients from 105 separate studies." Also, "Ketalar has a wide margin of safety." I feel confident now that Ketalar is a safe medication for me.

    
    

    In addition, Dr. Royce demonstrated to me how his Oxygen Resuscitator works in case he has to use it on me by breathing through it himself. Even when

    he held his breath, I could hear the machine cycling on and off, doing the breathing for him.

    Finally for thoroughness Dr. Royce and I made the following notes by referring to the P.D.R.:

    1. I will not become pregnant during the time when I am being treated.

    2. I will not take anything by mouth after midnight of the day before each Ketalar treatment.

    3. I will always bring some adult with me when I come here for the Ketalar treatments.

    4. I will take Valium 5 mg orally 45 minutes before the Ketalar instead of the 2 mg to 5mg intra- venously described in the P.D.R.

    5. The valium is to help prevent "an EMERGENCE REACTION." I understand this reaction to be a period of emotional excitement which can occur in some instances when higher doses of Ketalar are used such as during surgery and where the

       prophylactic dose of Valium or some other sedative is not given to the patient before Ketalar. 24/

    6. The initial does of Ketalar will be "from 0.5 mg to 2.0 mg per pound.["] Therefore at my present weight of 167 lbs., no more than 334 mg will be used.

    7. After the Ketalar Therapy, I will wait one hour in the office discussing whatever seems to be important to me with Dr. Royce's assistants (Mrs. Royce and/or their daughter Jacki.) After the one-hour period, I will be examined by Dr. Royce who will dismiss me if he sees that I have recovered completely from the Ketalar Treatment.

    8. I will not drive an automobile or operate electrical or hazardous machinery for at least

       24 hours after each Ketalar treatment.

    9. I will report to Dr. Royce anything unusual which occurs to me in the interval between Ketalar Treatments, such as fever, rash, nausea, infection, or unusual thoughts, dreams, or daydreams.

    
    

    No guarantee of results has been given to me by Dr. Royce, Mrs. Royce or Jacki.

    
    

66. The Ketamine-assisted psychotherapy sessions began on C.R.'s next visit, which was on November 10, 1984.

    
    

67. On that same date, she signed another handwritten statement in which she acknowledged that she was borrowing copies of nine different "scientific" articles dealing with or related to Ketamine use and agreed to return these borrowed materials to Respondent after she had "had time to read them."

    
    

68. At no time during the treatment period did Respondent administer Ketamine in a dosage or manner that was calculated to, or did in fact, anesthesize C.R. or subject her to undue risk or harm.

    
    

69. On only two occasions, toward the end of the treatment period, did he administer more than 100 milligrams of Ketamine during a session: the April 26, 1985, session, when he administered 112.5 milligrams; and the June 6, 1985, session when he administered 125 milligrams. 25/

70. On each and every occasion, Respondent administered the Ketamine slowly over a period of time to avoid anesthesizing C.R.

    
    

71. There was no reason for Respondent to believe that the interaction between the Ketamine and any of the other drugs he had administered to C.R. or prescribed for her would result in any adverse consequences.

    
    

72. At no time did Respondent teach C.R. how to self-administer Ketamine, nor did he ever approve or sanction such self-administration.

    
    

73. Following each Ketamine-assisted psychotherapy session, which generally lasted at least an hour, C.R. remained in Respondent's office, in the company of Respondent's wife and/or his daughter Jacqueline, for a minimum of another hour to an hour and a half. C.R. was not permitted to leave until it was determined that it was safe for her to do so.

    
    

74. The last Ketamine-assisted psychotherapy session was on June 11, 1985.

    
    

75. Respondent stopped using Ketamine as an adjunct to psychotherapy because he reasonably believed that, in light of the progress C.R. had made, she no longer needed to rely on the drug's abreactive or dissociative effect in order to engage in effective psychotherapy.

    
    

76. Instead of Ketamine, he used Brevital for C.R.'s last seven drug- assisted psychotherapy sessions.

    
    

77. The final drug-assisted psychotherapy session was held on July 9, 1985, which was the last time Respondent saw C.R.

    
    

    Electric Current Therapy

    
    

78. Electroconvulsive therapy is an accepted treatment for serious depression involving the delivery, to electrodes placed on the patient's skull, of a measured amount of electric current (on the average 350 millilamps) sufficient to produce a seizure or convulsion. Ordinarily, the patient is premedicated with an anesthetic and medication to modify the convulsion and its impact.

    
    

79. Respondent recommended that C.R. be hospitalized and receive in- hospital electroconvulsive therapy. C.R.'s reaction to the recommendation was a "very negative" one.

    
    

80. She did agree, however, to undergo non-convulsive electric current therapy, which is helpful in treating anxiety and in facilitating effective psychotherapy.

    
    

81. She gave her consent in two signed, handwritten statements, one dated November 13, 1984, and the other dated January 31, 1985.

    
    

82. C.R.'s November 13, 1984, statement read as follows: Permit for a Series of Electric-shock Treatments

    This is to give permission to Irving D. Royce, M.D. and to members of his office staff to administer a series of Electric Shock Treatments to me to treat my mental illness. These treatments will be given

    to me in addition to the Psychotherapy and medica- tions prescribed for me.

    
    

    The treatment procedure will include having electrodes placed on my head. Then an electric current will flow through the electrodes. There will be no pain or danger of a convulsion because of the very low amount of amperes that will flow. Medications which may be used during the series of electric treatments may include Atropine, Anectine, Brevital or Pentothal, and/or oxygen.

    
    

    I understand that these treatments are frequently effective (especially in regard to anxiety and/or depression) because they theoretically modify the chemical reactions within the brain. Other possible therapies have been discussed with me by Dr. Royce, including anti-depressant medication, psychotherapy, behavior modification, and convulsive electro-shock treatments (plus combination of these techniques.) However, I prefer at this time to start a series of the electro-shock treatment described in the second paragraph above, anywhere from five to twelve in number to comprise the series.

    
    

    I also understand that these treatments are not effective 100 percent of the time. Dr. Royce has also warned me that there have been side-effects reported in the literature but that patients he has known have not had any persistent complaints.

    Adverse reactions which have been reported included excitement and sedation. The injections may also cause local irritation of the skin.

    
    

    I am not pregnant and shall wait until the treat- ments are completed before considering becoming pregnant, although pregnancy is not in my plans at this time or in the near-future.

    
    

    Also, I agree to wait in Dr. Royce's office for at least an hour after each treatment, until he advises me that I may safely allow a responsible person to drive me home. I have been advised not to drive an automobile, not to operate any machinery, and to stay at home for the remainder of the day after each treatment.

    
    

    The actions and possible side-effects of each medication listed above has been described to me by Dr. Royce. In addition, I have been advised

    of the antidepressant and other actions of TOFRANIL, ELAVIL, MARPLAN, NARDIL, PARNATE, AMPHETAMINE, PLEGINE, AND DIDREX.

    
    

    No guarantees have been given to me as to the results which may be achieved by this course of treatment.

83. C.R.'s January 31, 1985, statement read as follows: Permission for Electro-shock Treatment

    I, [C.R.], hereby give permission to Irving D. Royce, M.D., and his assistants to give me a series of electro-shock treatments, using Anectine, Brevital, Pentothal, and/or Atropine and any related medication. I have occasional back pain from a previous injury.

    
    

84. Respondent retained C.R.'s November 13, 1984, and January 31, 1985, statements as part of his medical records on C.R.

    
    

85. On seven different occasions, from January 31, 1985, to March 15, 1985, Respondent administered non-convulsive electric current therapy to C.R. using a Reiter Electrostimulator (Model CW47).

    
    

86. Before doing so he did not consult with any other physician.

    
    

87. In administering non-convulsive electric current therapy to C.R. without consulting with and obtaining the agreement of another physician, Respondent did not act in a manner that was inconsistent with what a reasonably prudent psychiatrist at the time would have done under similar circumstances.

    
    

88. Given C.R.'s symptomatology, such therapy was not inappropriate. Rather, it was indicated.

    
    

89. Some time after leaving Respondent's office following the fifth non- convulsive therapy session on February 22, 1985, C.R. returned to the office for a second visit, during which she received Ketamine-assisted psychotherapy. Following the sixth non-convulsive electric therapy session on March 8, 1985,

    C.R. appeared to be disturbed about something and delayed leaving Respondent's office. To help reduce her anxiety, Respondent decided to have a Ketamine- assisted psychotherapy session with her before she left the office that day. These were the only occasions that Respondent administered both non-convulsive electric current therapy and Ketamine to C.R. on the same date. 26/ In doing so on these two occasions, Respondent did not act in a manner that was inconsistent with what a reasonably prudent psychiatrist at the time would have done under similar circumstances.

    
    

90. The Reiter Electrostimulator that Respondent used to administer electric current therapy had three different settings, only one of which, Setting 3, was designed to generate a current sufficient to produce a seizure or convulsion. Respondent never used Setting 3 in treating C.R. He only used Settings 1 and 2, which produced non-convulsive stimulation.

    
    

91. Although it was always Respondent's intention to comply with C.R.'s wishes and administer non-convulsive, not convulsive, electric current therapy, Respondent took the prudent precautionary measure before each electric current therapy session of premedicating C.R. with Brevital, Atropine and Anectine in the highly unlikely event that there was a mishap resulting in C.R. suffering a seizure or convulsion during a session.

    
    

92. Such a mishap never occurred. At no time during any electric current therapy session did C.R. have a seizure or convulsion.

93. Furthermore, she suffered no adverse reaction of any kind to the therapy.

    
    

94. Nonetheless, the non-convulsive electric current therapy was discontinued because Respondent felt that, in light of the improvement C.R. had made, his time with her would be better spent pursuing other treatment alternatives.

    
    

95. Although the electric current therapy administered to C.R. was at all times non-convulsive in nature, Respondent did not so indicate in the medical records that he maintained on C.R.

    
    

96. In these records, Respondent used the abbreviation "ECT" to refer to the non-convulsive electric current therapy he was administering to C.R.

    
    

97. "ECT" was then, as it is now, understood by most practitioners to refer to electrconvulsive therapy, although it has also been used by some practitioners to indicate electric current therapy of any type. Therefore, at best, Respondent's medical records convey that Respondent administered some form of electric current therapy in treating C.R., but leave the reader to speculate whether the therapy was convulsive or non-convulsive in nature. 27/ At worst, they inaccurately suggest that Respondent administered electroconvulsive therapy to C.R.

    
    

    C.R.'s Rectal Fissure

    
    

98. Respondent never treated C.R.'s rectal fissure.

    
    

99. Rather, he insisted that she be treated by a specialist.

    
    

100. He provided her with medication for the pain she was experiencing as a result of the fissure only after she had made an appointment to see a specialist.

     
     

101. In providing C.R. with such pain medication, Respondent was not practicing outside the scope of his competence or expertise.

     
     

102. In January and February of 1985, David Ornstein, M.D., an internist and gatroenterologist, provided C.R. with treatment for her rectal fissure.

     
     

103. Following such treatment, Dr. Ornstein instructed C.R. to follow-up with her psychiatrist for psychiatric care.

     
     

     C.R.'s Death

     
     

104. On July 11, 1985, C.R. was found dead on the floor in the kitchen of her apartment. She was sitting with her legs crossed and her upper body bent forward. Her head was almost touching the floor. Next to her, lying on the floor, was a telephone receiver.

     
     

105. A search by police of the apartment and its contents revealed, among other things: hypodermic needles; syringes; two empty vodka bottles; a large number of empty, partially filled, and filled, labelled 28/ and unlabelled medication vials and containers; 29/ and labelled audio cassette tapes. 30/

106. An autopsy was conducted on C.R.'s body by the Dade County Medical Examiner's Office.

     
     

107. The autopsy revealed the presence of neither alcohol, cocaine or Ketamine in C.R.'s bloodstream.

     
     

108. Phenobarbital 31/ and Placidyl, however, were detected. The amount of the former, but not the latter, was in the fatal range. Other drugs, such as Valium, were determined to be present, but merely in insignificant trace amounts.

     
     

109. C.R.'s lungs were congested. Such congestion is common in drug- related deaths.

     
     

110. Small linear marks, which appeared to be needle track scars, were discovered on C.R.'s left arm. 32/

     
     

111. After the autopsy was performed, the Dade County Medical Examiner's Office determined that C.R.'s death was accidental, that the immediate cause of her death was acute "polydrug [to wit: Phenobarbital and Placidyl 33/ ] intoxication," and that "positional asphyxia" was a secondary contributing factor.

     
     

112. There was no evidence that C.R.'s death was the result of chronic substance abuse.

     
     

     CONCLUSIONS OF LAW

     
     

     General Legal Principles

     
     

113. The Board of Medicine (hereinafter referred to as the "Board") is statutorily empowered to take disciplinary action against a physician licensed to practice medicine in the State of Florida based upon any of the grounds enumerated in Section 458.331(1), Florida Statutes.

     
     

114. Where the disciplinary action sought is the revocation or suspension of the physician's license, the proof of guilt must be clear and convincing. See Section 458.331(3), Fla. Stat.; Ferris v. Turlington, 510 So.2d 292 (Fla. 1987); Pic N' Save v. Department of Business Regulation, 601 So.2d 245 (Fla. 1st DCA 1992); Munch v. Department of Professional Regulation, 592 So.2d 1136 (Fla. 1st DCA 1992); Newberry v. Florida Department of Law Enforcement, 585 So.2d 500 (Fla. 3d DCA 1991). "The evidence must be of such weight that it produces in the mind of the trier of fact a firm belief or conviction, without hesitancy, as to the truth of the allegations sought to be established." Slomowitz v. Walker, 429 So.2d 797, 800 (Fla. 4th DCA 1983).

     
     

115. Where the discipline does not involve the loss of licensure, the physician's guilt need be established by only a preponderance of the evidence. See 458.331(3), Fla. Stat.; Allen v. School Board of Dade County, 571 So.2d 568, 569 (Fla. 3d DCA 1990).

     
     

116. Regardless of the disciplinary action taken, it may be based only upon the violations specifically alleged in the administrative complaint. See Kinney v. Department of State, 501 So.2d 129, 133 (Fla. 5th DCA 1987); Hunter

     v. Department of Professional Regulation, 458 So.2d 842, 844 (Fla. 2d DCA 1984).

117. In addition, in determining whether Section 458.331(1), Florida Statutes, has been violated in the manner charged in the administrative complaint, one "must bear in mind that it is, in effect, a penal statute. . . This being true the statute must be strictly construed and no conduct is to be regarded as included within it that is not reasonably proscribed by it. Furthermore, if there are any ambiguities included such must be construed in favor of the . . . licensee." Lester v. Department of Professional and Occupational Regulations, 348 So.2d 923, 925 (Fla. 1st DCA 1977).

     
     

     Respondent's Motion to Dismiss

     
     

118. At hearing, Respondent did not present any evidence in support of his contention that, because the "sole 'problem' found by the Probable Cause Panel, for which it authorized the issuance of the Administrative Complaint, centered around the use of Ketamine," "any allegation [in the Administrative Complaint] not relevant nor material to the use of Ketamine" should be dismissed. In the absence of such supporting evidence, his motion should be denied. See State v. Wallace, 401 So.2d 863, 864 (Fla. 1st DCA 1981)("[a]lthough appellee's allegations, if established, would no doubt support an order of dismissal [of the information filed against him on the ground of denial of a speedy trial], the difficulty with appellee's case is that no evidence was presented at the hearing on the motion to dismiss, only arguments by counsel;" "[t]he burden was upon the appellee to establish by competent and substantial evidence the thrust of his allegations"); Florida Department of Transportation v. J.W.C. Company, Inc., 396 So.2d 778, 788 (Fla. 1st DCA)("[i]n accordance with the general rule, applicable in court proceedings, 'the burden of proof, apart from statute, is on the party asserting the affirmative of an issue before an administrative tribunal'").

     
     

     Count One

     
     

119. Count One of the Administrative Complaint issued in the instant case alleges that, in connection with his care and treatment of C.R., Respondent violated Section 458.331(1)(m), Florida Statutes, in that "Respondent's medical records of [C.R.] do not justify Respondent's failure to diagnose [C.R.'s] abusive and addictive personality; Respondent's medical records do not justify Respondent's inappropriate and excessive prescribing of controlled substances and other legend drugs, especially Ketalar, over a ten (10) month period; Respondent's medical records failed to justify Respondent's failure to seek a consultation with another physician, and document said consultation [prior] to performing ECT on [C.R.]; [and] Respondent's medical records fail to justify Respondent's inappropriate use of Ketalar (Ketamine) treatment concomitantly with ECT."

     
     

120. Respondent correctly points out in his proposed recommended order 34/ that "Count [One] is flawed, in that it alleges a violation of Section 458.331(1)(m), Florida Statutes, in failing to keep written medical records justifying the course of treatment of the patient," but "[i]n fact, under the law in effect at the time (1984-1985) that Respondent treated the patient . . . Section 458.331(1)(m), [Florida Statutes, proscribed] soliciting patients through the use of fraud, intimidation, undue influence, or a form of overreaching or vexatious conduct." The flaw, however, is not, contrary to the

     position taken by Respondent, a fatal one warranting the dismissal of this count of the Administrative Complaint. The Department simply cited the wrong subsection of the version of Section 458.331, Florida Statutes, that was in effect at the time of the alleged violations. Instead of subsection (1)(m), it should have referenced subsection (1)(n) of the statute. This mistake in no way

     misled or otherwise prejudiced Respondent. Accordingly, it should be treated as a mere scrivener's error and not have any impact on the disposition or outcome of the instant case. See Danzy v. State, 603 So.2d 1320, 1322 (Fla. 1st DCA 1992); Sanders v. State, 386 So.2d 256, 257 (Fla. 5th DCA 1980); Youngker v.

     State, 215 So.2d 318, 322 (Fla. 4th DCA 1968); see also Seminole County Board of County Commissioners v. Long, 422 So.2d 938, 940 (Fla. 5th DCA 1982)("[a] complaint filed by an administrative agency is not required to fulfill the technical niceties of a pleading filed in a court of law;" "[s]uch an administrative complaint must only be specific enough to inform the accused with reasonable certainty of the nature of the charge").

     
     

121. At all times material to the instant case subsection (1)(n) of Section 458.331, Florida Statutes, authorized the Board to discipline a Florida- licensed physician for "[f]ailing to keep written medical records justifying the course of treatment of the patient, including, but not limited to, patient histories; examination results, and test results." 35/

     
     

122. This statutory provision does not purport to encompass "JCAH standards or those of a 'reasonably prudent physician;'" nor can it "be interpreted as authorizing disciplinary action for a physician's failure to document in a patient's medical chart a basis for not undertaking a particular course of treatment." Breesmen v. Department of Professional Regulation, Board of Medicine, 567 So.2d 469, 471 (Fla. 1st DCA 1990).

     
     

123. It does impose upon the physician, however, an obligation to provide sufficient documentation "so that 'neutral third parties can observe what transpired during the course of treatment of a patient.'" Robertson v. Department of Professional Regulation, Board of Medicine, 574 So.2d 153, 156-57 (Fla. 1st DCA 1990).

     
     

124. In the instant case, Respondent failed to meet this obligation by not documenting the following in the medical records that he maintained on C.R.:

     his belief that C.R.'s claims of cocaine and excessive alcohol use were "attention-getting" fabrications and the basis of this belief; 36/ his instructions to C.R. that the Plegine and Didrex he prescribed for her during the same visit be used sequentially and not concomitantly; 37/ and the true nature of the electric current therapy he administered to C.R. 38/

     
     

125. His failure to have included such information in his medical records was a violation of former subsection (1)(n) of Section 458.331, Florida Statutes, for which he should be disciplined.

     
     

126. In all other material respects, Respondent's records provide sufficient information to give "neutral third parties" a reasonably clear understanding of what Respondent did to treat C.R. during the time that she was under his care and the circumstances that led him to follow such a course of treatment. Accordingly, to the extent that Count One alleges that Respondent otherwise violated former subsection (1)(n) of Section 458.331, Florida Statutes, it is not supported by even a preponderance of the evidence and accordingly should be dismissed.

     
     

     Count Two

     
     

127. Count Two of the Administrative Complaint issued in the instant case alleges that, in connection with his care and treatment of C.R., Respondent violated Section 458.331(1)(q), Florida Statutes, "in that Respondent prescribed Plegine for [C.R.], when Respondent knew or had reason to have known that said

     patient had a history of drug abuse; Respondent inappropriately prescribed Plegine concomitantly with Didrex, a CNS stimulant, for [C.R.]; Respondent inappropriately administered Ketalar, in conjunction with ECT treatment; Respondent inappropriately and excessively prescribed the following controlled substances: Benzodiazepines, Barbiturates, Amphetamines, and Ketalar."

     
     

128. At all times material to the instant case, subsection (1)(q) of Section 458.331, Florida Statutes, has authorized the Board to discipline a Florida-licensed physician for "[p]rescribing, dispensing, administering, mixing or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's practice" and has further provided as follows:

     
     

     For the purposes of this paragraph, it shall be legally presumed that prescribing, dispensing, administering, mixing, or otherwise preparing legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician's

     professional practice, without regard to his intent.

     
     

129. It has not been established by even a preponderance of the evidence that: Respondent knew or had reason to believe that C.R. had a history of drug abuse; Respondent acted inappropriately, that is, contrary to what a reasonably prudent similar physician would have recognized as being acceptable under similar conditions and circumstances, in concomitantly prescribing Plegine and Didrex (but for sequential, not concomitant, use); Respondent administered electroconvulsive therapy to C.R.; Respondent administered Ketalar (Ketamine) to C.R. "in conjunction with" electric current therapy of any type;

     Respondent's use of Ketalar (Ketamine) as an adjunct to C.R.'s psychotherapy was at any time, including February 22 and March 8, 1985, when it was administered following a non-convulsive electric current therapy session, either inappropriate or excessive; Respondent prescribed (rather than administered) Ketalar (Ketamine) for C.R.; Respondent prescribed, dispensed or administered any amphetamines; or Respondent prescribed, dispensed or administered any benzodiazepines, barbiturates or any other controlled substances inappropriately or in excessive amounts.

     
     

130. Accordingly, Count Two should be dismissed in its entirety.

     
     

     Count Three

     
     

131. Count Three of the Administrative Complaint issued in the instant case alleges that, in connection with his care and treatment of C.R., Respondent violated Section 458.331(1)(t), Florida Statutes, "in that Respondent failed to diagnose [C.R.'s] addictive and abusive personality; Respondent inappropriately and excessively prescribed legend drugs, most of which were controlled substances, over a ten (10) month period to [C.R.] without proper justification; Respondent failed to acquire a consultation with another physician before ordering ECT for [C.R.]; Respondent inappropriately administered ECT treatments in conjunction with Ketalar therapy; and Respondent utilized ECT treatments when they were not indicated."

     
     

132. At all times material to the instant case, subsection (1)(t) of Section 458.331, Florida Statutes, has authorized the Board to discipline a Florida-licensed physician for "[g]ross or repeated malpractice or the failure

     to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances."

     
     

133. It has not been established by even a preponderance of the evidence that: in failing to conclude that C.R. had an addictive or abusive personality, Respondent acted in a manner that deviated from what a reasonably prudent similar physician would have recognized as being acceptable under similar conditions and circumstances; Respondent prescribed, dispensed or administered any legend drugs during the treatment period inappropriately, excessively or without reasonable justification; Respondent administered electroconvulsive therapy (as opposed to non-convulsive electric current therapy) to C.R.; the non-convulsive electric current therapy that Respondent administered to C.R. was at any time, including February 22 and March 8, 1985, when it was administered prior to a Ketamine-assisted psychotherapy session held later the same day, inappropriate or not indicated; a reasonably prudent similar physician would have consulted with another physician before administering such non-convulsive electric current therapy; or Respondent administered such non-convulsive electric current therapy "in conjunction with Ketalar therapy."

     
     

134. Accordingly, Count Three should be dismissed in its entirety.

     
     

     Count Four.

     
     

135. Count Four of the Administrative Complaint issued in the instant case alleges that, in connection with his care and treatment of C.R., Respondent violated Section 458.325(2), Florida Statutes, and therefore Section 458.331(1)(x), Florida Statutes, in that "Respondent failed to have [C.R.'s] treatment record reviewed, and the proposed Electroconvulsive Therapy agreed to by another physician, not directly involved with [C.R.], before the electroconvulsive therapy was administered to [C.R.]."

     
     

136. At all times material to the instant case, subsection (1)(x) of Section 458.331, Florida Statutes, has authorized the Board to discipline a Florida-licensed physician for "[v]iolating any provision of this chapter."

     
     

137. At all times material to the instant case, Section 458.325(2), Florida Statutes, has provided as follows:

     
     

     Before convulsive therapy or psychosurgery may be administered, the patient's treatment record shall be reviewed and the proposed convulsive therapy or psychosurgery agreed to by one other

     physician not directly involved with the patient. Such agreement shall be documented in the patient's treatment record and shall be signed by both physicians.

     
     

138. It is undisputed that Respondent did not take the measures prescribed by Section 458.325(2), Florida Statutes, at any time during the treatment period. He was not required to do so, however, inasmuch as he never administered electroconvulsive therapy to C.R. While he did administer electric current therapy during the treatment period, it was always of the non-convulsive type, to which the requirements of Section 458.325(2), Florida Statutes, did not apply.

139. Accordingly, Count Four should be dismissed in its entirety.

     
     

     Count Five

     
     

140. Count Five of the Administrative Complaint issued in the instant case alleges that, in connection with his care and treatment of C.R., Respondent violated Section 458.331(1)(v), Florida Statutes, in that "Respondent practiced outside his expertise by treating [C.R.'s] rectal fissure during the course of her psychiatric treatment."

     
     

141. At all times material to the instant case, subsection (1)(v) of Section 458.331, Florida Statutes, has authorized the Board to discipline a Florida-licensed physician for "[p]racticing or offering to practice beyond the scope permitted by law or accepting and performing professional responsibilities which the licensee knows or has reason to know that he is not competent to perform."

     
     

142. It has not been established by even a preponderance of the evidence that Respondent treated C.R.'s rectal fissure. He simply provided her with medication for the pain she was experiencing as a result of the fissure. In doing so, he was performing a professional responsibility he was competent to undertake.

     
     

143. Accordingly, Count Five should be dismissed in its entirety.

     
     

     Count Six

     
     

144. Count Six of the Administrative Complaint issued in the instant case alleges that, in connection with his care and treatment of C.R., Respondent violated Section 458.331(1)(u), Florida Statutes, in that "Respondent treated [C.R.'s] psychiatric condition with Ketalar (Ketamine) and utilized Ketalar (Ketamine) in conjunction with ECT treatments" without "first obtaining full, informed and written consent" from C.R..

     
     

145. At all times material to the instant case, subsection (1)(u) of Section 458.331, Florida Statutes, has authorized the Board to discipline a Florida-licensed physician for "[p]erforming any procedure or prescribing any therapy which, by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject, without first obtaining full, informed, and written consent."

     
     

146. While it is undisputed that Respondent used Ketalar (Ketamine) as an adjunct to psychotherapy in his treatment of C.R., it has not been established by even a preponderance of the evidence that he did so "in conjunction with ECT treatments." Moreover, Respondent obtained C.R.'s "full, informed, and written consent," in the form of her signed November 6, 1984 "Permit to Dr. Royce" (Respondent's Exhibit 6) before he engaged in Ketamine-assisted psychotherapy with her.

     
     

147. Accordingly, Count Six should be dismissed in its entirety.

     
     

     Penalty

     
     

148. At all times material to the instant case, Section 458.331(2), Florida Statutes, authorized the Board to impose one or more of the following penalties for a violation of subsection (1) of Section 458.331, Florida Statutes: license revocation; license suspension; restriction of practice;

     imposition of an administrative fine not to exceed $1,000 for each count or separate offense; issuance of a reprimand; and placement of the physician on probation. Although the Legislature has since increased to $5,000.00 the amount of the maximum fine that the Board may impose per violation and added additional potential penalties, Respondent is subject to only those penalties that were statutorily authorized at the time of the violations he committed. See Willner

     v. Department of Professional Regulation, Board of Medicine, 563 So.2d 805, 806 (Fla. 1st DCA 1990)("[s]ince all the violations for which appellant [a licensed physician] was found guilty occurred prior to the effective date of the 1986 amendment [to Section 458.331(2), Florida Statutes, increasing the maximum fine to $5,000.00 per violation], the maximum fine which could lawfully be imposed [upon appellant] was $1,000.00 per violation").

     
     

149. In determining which of the foregoing penalties the Board should select, it is necessary to consult Chapter 59R-8, Florida Administrative Code, which contains the disciplinary guidelines adopted by the Board. Cf. Williams

     v. Department of Transportation, 531 So.2d 994, 996 (Fla. 1st DCA 1988)(agency is required to comply with its disciplinary guidelines in taking disciplinary action against its employees).

     
     

150. Subsection (2) of Rule 59R-8.001, Florida Administrative Code, sets forth "the range of penalties which will routinely be imposed" for a "single count violation" of each of the statutory provisions listed.

     
     

151. For a "single count violation" of subsection (1)(m) (formerly subsection (1)(n))of Section 458.331, Florida Statutes, the normal "range of penalties," as prescribed by subsection (2) of Rule 59R-8.001, Florida Administrative Code, is a minimum of a reprimand up to a maximum of a two year suspension of the physician's license, followed by probation, and an administrative fine.

     
     

152. Subsection (3) of Rule 59R-8.001, Florida Administrative Code, provides that the Board may impose a penalty outside the normal range where there are mitigating or aggravating circumstances.

     
     

153. The mitigating or aggravating circumstances that, according to subsection (3) of Rule 59R-8.001, Florida Administrative Code, may warrant such a deviation are as follows:

     
     

     1. Exposure of patient or public to injury or potential injury, physical or otherwise: none, slight, severe or death;

     2. Legal status at the time of the offense: no restraints or legal constraints;

     3. The number of counts or separate offenses established;

     4. The number of times the same offense or offenses have previously been committed by the licensee . . .;

     5. The disciplinary history of the . . . licensee in any jurisdiction and the length of practice;

     6. Pecuniary benefit or self-gain inuring to the . . . licensee;

     7. Any other relevant mitigating factors.

154. Subsection (1) of Rule 59R-8.001, Florida Administrative Code, provides that "[m]ultiple counts of the violated provision or a combination of the violations may result in a higher penalty than that for a single, isolated violation."

     
     

155. Having carefully considered the facts of the instant case, in light of the statutory and rule provisions set forth above, the Hearing Officer concludes that, for having committed the violations of former subsection (1)(n) of Section 458.331, Florida Statutes, noted above, Respondent should be issued a reprimand.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board enter a final order finding Respondent guilty of the violations of former subsection (1)(n) of Section 458.331, Florida Statutes, noted above, disciplining him for having committed these violations by issuing him a reprimand, and dismissing the remaining charges against him.

DONE AND ENTERED in Tallahassee, Leon County, Florida, this 18th day of January, 1995.

STUART M. LERNER

Hearing Officer

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-1550

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 18th day of January, 1995.

ENDNOTES

1/ Petitioner was represented by Blazicek on the first day of hearing and by Metzger for the remaining portion of the hearing and subsequent post-hearing matters.

2/ "ECT," as used in the Administrative Complaint, is, according to paragraph

55 of the Administrative Complaint, intended to signify "Electroconvulsive Therapy."

3/ A copy of the transcript was appended to the motion.

4/ Notwithstanding the objections made by Respondent to the admissibility of certain portions of Dellerson's deposition, the Hearing Officer has considered the deposition in its entirety, although he has not credited and relied upon all of the testimony Dellerson gave during the deposition.

5/ Mash-Geller also happens to be the wife of counsel for Respondent.

6/ Although Mash-Geller is not a medical doctor, she is actively and directly involved in medical education and research and is extremely knowledgeable in the areas of clinical neuroscience and neuropharmacology, which are fields of medicine related to psychiatry.

7/ Respondent's Exhibit 24 was marked for identification, but not offered into evidence.

8/ In his post-hearing submittal, Respondent advised that he was withdrawing Respondent's Exhibit 22. Accordingly, the issue of the admissibility of this exhibit is now moot.

9/ All post-hearing requests to reverse evidentiary rulings made at hearing concerning the admissibility of evidence have been denied. In making his findings of facts in this case, the Hearing Officer has considered (although not necessarily accorded any weight to) all evidence offered at hearing not specifically rejected by the Hearing Officer or withdrawn by the offering party.

10/ Effective July 1, 1994, pursuant to Chapter 93-129, Laws of Florida, the Agency was transferred the authority that the Department had previously possessed to regulate the practice of medicine in this state, including the licensure of those engaging in such practice. On that date, it therefore became the Department's successor in this proceeding.

11/ The Agency's proposed recommended order is 62 pages. Respondent's proposed recommended order is 110 pages.

12/ In making this finding, the Hearing Officer has considered, but rejected as unworthy of belief because it is inconsistent with other testimony that, in the opinion of the Hearing Officer is more credible, the evidence that Respondent made statements to Dellerson indicating that he believed otherwise.

13/ Contrary to the assertion made in the Administrative Complaint, the drugs that were prescribed and administered did not include any amphetamines.

14/ M.A.O. inhibitors comprise a third group of drugs used as antidepressants. 15/ While "amphetamine-like," they are not amphetamines.

16/ The Ketamine that Respondent used was not supplied by C.R. Rather, it came from bottles of Ketamine that were part of Respondent's inventory. Respondent placed labels bearing C.R.'s name on these bottles and administered their contents to only Respondent and no other patient.

17/ While it is commonly used, Ketamine is not a widely abused drug, although it is subject to abuse.

18/ That is to say, there are less risks associated with the use of Ketamine than with the use of other anesthetics. There is no anesthetic that is totally safe.

19/ Inasmuch as it has been approved by the FDA as safe for human use, it cannot be considered an experimental drug, even if used for a purpose other than that which is indicated on its label and package insert.

20/ Although Ketamine and PCP are chemically related, their pharmacodynamics are not identical. The former is considerably less dangerous than the latter.

21/ For the average 150-pound male, the anesthetic dose of Ketamine is between

70 to 100 milligrams.

22/ For the very same reason, however, it is helpful in treating patients who are in shock or are hypotensive.

23/ A dose of Ketamine in the 70 to 100 milligram range, administered slowly to a person weighing approximately 150 pounds, will act as a tranquillizer. If administered quickly, however, it likely will have an anesthetic effect.

24/ Valium is frequently used in conjunction with Ketamine when the latter is employed to anesthesize a patient undergoing surgery. It serves a useful purpose in both the pre-surgery period and the post-surgery recovery period in helping to allay anxiety and emotional excitement. Moreover, it does not potentiate any of the adverse effects of Ketamine.

25/ There were two separate Ketamine-assisted psychotherapy sessions on both February 12, 1985, and May 30, 1985. On each of these dates, C.R. received a total of more 100 milligrams for the two sessions combined, but during no one session on either of these dates did she receive more than 100 milligrams.

26/ Although Ketamine was administered on these two dates, it is inaccurate to state, as the Department did in paragraphs 107, 110 and 113 of the Administrative Complaint, that the Ketamine was administered "concomitantly with" or "in conjunction with" the electric current therapy she received those days.

27/ While C.R.'s November 13, 1984, and January 31, 1985, written statements were made a part of Respondent's file on C.R., these documents purport to describe the type of electric current therapy to which C.R. consented, not the type she actually was administered.

28/ The labels of some, but not all, of these labelled vials and containers, bore the name of Respondent as the prescribing physician.

29/ Although Ketamine bottles were found in the apartment, there was no indication that they were prescribed or dispensed by Respondent.

30/ One of the tapes was labelled "Doctor." Another tape was labelled "At Home." A third tape was labelled "Self Injection." Dellerson listened to approximately ten of the tapes. On these tapes, she heard female voices, but no male voices. It sounded to Dellerson as if these were recordings of someone "under the influence of a drug," although, she recognized, the tapes may have been "distorted."

31/ In his treatment of C.R., Respondent never prescribed, dispensed or administered Phenobarbital.

32/ In evaluating the significance of this discovery, it must be remembered that C.R. received a number of intravenous injections while under Respondent's care which may have produced these linear marks.

33/ Although there was a toxic level of Phenobarbital, but only a therapeutic level of Placidyl that alone would not have killed C.R., the Medical Examiner's Office nonetheless termed the immediate cause of death "polydrug intoxication"

because Placidyl combined with Phenobarbital has a synergistic effect on respiration.

34/ Respondent raises this issue for the first time in his proposed recommended order.

35/ The current version of this statutory provision is found in subsection (1)(m) of Section 458.331, Florida Statutes, which authorizes the Board to discipline a Florida-licensed physician for "[f]ailing to keep written medical records justifying 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."

36/ The pharmacological component of the course of treatment that Respondent followed would not have been justified if Respondent had no reason to believe that these claims were false.

37/ It would have been inappropriate for Respondent to have prescribed Plegine and Didrex for concomitant use. While the Hearing Officer has concluded, based upon Respondent's testimony, that Respondent did not engage in such an inappropriate prescribing practice, it is not all clear from Respondent's records whether the Plegine and Didrex he prescribed for C.R. were prescribed for concomitant or sequential use.

38/ Had he administered electroconvulsive therapy, Respondent would have needed the prior written approval of another physician with no direct involvement with C.R., which he did not obtain. The Hearing Officer has concluded, based upon Respondent's testimony, that Respondent did not obtain such approval because it was never his intention to administer electroconvulsive therapy and that he only provided non-convulsive electric current therapy to C.R. Respondent's records, however, are reasonably susceptible of a contrary conclusion.

APPENDIX TO RECOMMENDED ORDER

The following are the Hearing Officer's specific rulings on the "findings of facts" proposed by the parties in their proposed recommended orders:

Agency's Proposed Findings

1-24. Accepted and incorporated in substance, although not necessarily repeated verbatim, in this Recommended Order.

1. To the extent that this proposed finding states that Respondent was not justified in failing to diagnose C.R. as having an abusive and/or addictive personality, it has been rejected because it lacks sufficient evidentiary support. To the extent that it states that Respondent's medical records do not reflect that he had such justification, it has been accepted and incorporated in substance.

2. To the extent that this proposed finding states that Respondent did not diagnose C.R. as having an abusive and/or addictive personality, it has been accepted and incorporated in substance. Otherwise, it has been rejected because it lacks sufficient evidentiary support.

3. To the extent that this proposed finding states that Respondent prescribed Plegine for C.R., it has been accepted and incorporated in substance. Otherwise, it has been rejected because it lacks sufficient evidentiary support.

4. To the extent that this proposed finding states that Respondent gave prescriptions for both Plegine and Didrex to C.R. during the same office visit, it has been accepted and incorporated in substance. Otherwise, it has been rejected because it lacks sufficient evidentiary support.

5. To the extent that this proposed finding states that Respondent gave

   C.R. prescriptions for controlled substances, including benzodiazepines, it has been accepted and incorporated in substance. Otherwise, it has been rejected because it lacks sufficient evidentiary support.

6. To the extent that this proposed finding states that Respondent's medical records document that he gave C.R. prescriptions for controlled substances and other legend drugs, it has been accepted and incorporated in substance. Otherwise, it has been rejected because it lacks sufficient evidentiary support.

7. To the extent that this proposed finding states that Respondent gave

   C.R. prescriptions for controlled substances and other legend drugs, it has been accepted and incorporated in substance. Otherwise, it has been rejected because it lacks sufficient evidentiary support.

8. To the extent that this proposed finding states that Respondent's medical records do not reflect that he sought to consult with another physician before administering electric current therapy to C.R., it has been accepted and incorporated in substance. To the extent that it states that the electric current therapy he administered to C.R. was convulsive, rather than non- convulsive, in nature, it has been rejected because it lacks sufficient evidentiary support.

9. To the extent that this proposed finding states that Respondent did not consult with another physician before administering electric current therapy to C.R., it has been accepted and incorporated in substance. To the extent that it states that the electric current therapy he administered to C.R. was convulsive, rather than non-convulsive, in nature, and that his failure to obtain a consultation before administering such therapy constituted a breach of the applicable standard of care, it has been rejected because it lacks sufficient evidentiary support.

10. To the extent that this proposed finding states that Respondent did not have another physician review C.R.'s treatment record and preapprove Respondent's plan to administer electric current therapy to C.R., it has been accepted and incorporated in substance. To the extent that it states that, in failing to do so, Respondent violated Section 458.325(2), Florida Statutes, it has been rejected as a finding of fact because it is more in the nature of a conclusion of law. To the extent that it states that the electric current therapy Respondent administered to C.R. was convulsive, rather than non- convulsive, in nature, it has been rejected because it lacks sufficient evidentiary support.

35-38. To the extent that these proposed findings state that Respondent administered Ketalar (Ketamine) to C.R. on the same day that he administered electric current therapy to her and that Respondent's medical records suggest (albeit erroneously) that the electric current therapy Respondent administered to C.R. was convulsive, rather than non-convulsive, in nature, they have been accepted and incorporated in substance. Otherwise, they have been rejected because they lack sufficient evidentiary support.

Respondent's Proposed Findings (which begin at numbered paragraph 96 of its proposed recommended order)

1. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: Accepted and incorporated in substance;

   Third sentence: Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

2. Before first comma: Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer; After first comma: Accepted and incorporated in substance.

3. Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

4. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: Accepted and incorporated in substance; Third sentence: Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

5. Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

6. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: Accepted and incorporated in substance; Third sentence: Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

7. Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

8. First sentence: Accepted and incorporated in substance; Second sentence: Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

9. Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

10. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

106-107. Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer.

1. First sentence: Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer; Second sentence: Accepted and incorporated in substance.

2. Accepted and incorporated in substance.

3. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: Accepted and incorporated in substance.

111-113. Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer.

114-115. Accepted and incorporated in substance.

116. Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

117-121. Accepted and incorporated in substance.

122. Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

123-125. Accepted and incorporated in substance.

1. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: Accepted and incorporated in substance.

2. First and second sentences: Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer; Third sentence: Accepted and incorporated in substance.

128-132. Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer.

133. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: Accepted and incorporated in substance.

134-136. Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer.

1. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: Accepted and incorporated in substance.

2. Before comma: Accepted and incorporated in substance; After comma: Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

3. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Remaining sentences: Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer.

140-143. Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer.

1. First sentence, before third comma: Accepted and incorporated in substance; First sentence, after third comma, and remaining sentences: Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer.

2. Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

3. Accepted and incorporated in substance.

147-149. Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer.

150-156. Accepted and incorporated in substance.

1. Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

2. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: Accepted and incorporated in substance; Remaining sentences: Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer.

3. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer; Third sentence: Accepted and incorporated in substance.

4. Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

5. Accepted and incorporated in substance.

6. First sentence: Rejected as a finding of fact because it is more in the nature of legal argument; Second sentence: Accepted and incorporated in substance.

7. Before last comma: Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer; After last comma: Rejected as a finding of fact because it is more in the nature of legal argument.

8. Rejected as a finding of fact because it is more in the nature of legal argument.

165-197. Rejected as findings of fact because they are more in the nature of a summaries or descriptions of evidence adduced at hearing than findings of fact based upon such evidence.

1. Accepted and incorporated in substance.

2. First sentence: Accepted and incorporated in substance; Second sentence: Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer

200-202. Accepted and incorporated in substance.

1. Rejected as a finding of fact because it is more in the nature of legal argument.

2. Accepted and incorporated in substance.

3. First sentence: Accepted and incorporated in substance; Second sentence: Rejected because it lacks sufficient evidentiary support.

206-208. Accepted and incorporated in substance.

209. To the extent that this proposed finding states that "barbiturates were prescribed on [only] a single occasion," it has been rejected because it lacks sufficient evidentiary support. Otherwise, it has been accepted and incorporated in substance.

210-211. Accepted and incorporated in substance.

1. Not incorporated in this Recommended Order because, even if true, it would not alter the outcome of the instant case.

2. Accepted and incorporated in substance.

3. Not incorporated in this Recommended Order because, even if true, it would not alter the outcome of the instant case.

4. Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

5. Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given evidence adduced at hearing.

6. To the extent that this proposed finding states that Respondent was justified in not concluding that C.R. was a drug and alcohol abuser, it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing and argument regarding the weight to be given such evidence than a finding of fact.

7. Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing and argument regarding the weight to be given such evidence than a finding of fact.

8. Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact.

9. To the extent that this proposed finding states that there were "no track marks" present at the time of the autopsy, it has been rejected because it lacks sufficient evidentiary support. Otherwise, it has been accepted and incorporated in substance.

10. First and third sentences: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact.

222-225. Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing and argument regarding the weight to be given such evidence than findings of fact.

226. To the extent that this proposed finding states that Respondent was justified in not concluding that C.R. was a drug and alcohol abuser, it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing and argument regarding the weight to be given such evidence than a finding of fact.

227-228. Rejected as findings of fact because they are more in the nature of legal arguments and arguments regarding the weight to be given evidence adduced at hearing.

229. Accepted and incorporated in substance.

230-231. Rejected as findings of fact because they are more in the nature of legal arguments and arguments regarding the weight to be given evidence adduced at hearing.

232. To the extent that these findings state that, in all material respects, Respondent's medical records on C.R. are accurate and complete in terms of describing what he did to treat C.R. during the time that she was under his care and the circumstances that led him to follow such a course of treatment, they have been rejected because they lack sufficient evidentiary support. To the extent that these proposed findings state that, in all material respects, Respondent's medical records on C.R. are accurate and complete, except insofar as they fail to document 1) Respondent's belief that C.R.'s claims of cocaine and excessive alcohol use were "attention-getting" fabrications and the basis of this belief, 2) his instructions to C.R. that the Plegine and Didrex he prescribed for her during the same visit be used sequentially and not concomitantly, and 3) the true nature of the electric current therapy he administered to C.R., these proposed findings have been accepted and incorporated in substance.

234-239. Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing and argument regarding the weight to be given such evidence than findings of fact.

1. Accepted and incorporated in substance.

2. To the extent that this proposed finding states that "barbiturates were prescribed on [only] a single occasion," it has been rejected because it lacks sufficient evidentiary support. Otherwise, it has been accepted and incorporated in substance.

3. To the extent that this proposed finding states that Respondent did not inappropriately prescribe Plegine to a patient he did not reasonably believe had a history of drug abuse, it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given evidence adduced at hearing.

4. First and second sentences: Accepted and incorporated in substance; Remaining sentences: Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing and argument regarding the weight to be given such evidence than findings of fact.

244-252. Accepted an incorporated in substance.

253. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: Accepted and incorporated in substance.

254-255. Accepted and incorporated in substance.

1. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact.

2. Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact.

3. First and third sentences: Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing than findings of fact; Second sentence: Accepted and incorporated in substance.

4. First and second sentences: Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing than findings of fact; Third sentence: Rejected as a finding of fact because it is more in the nature of a statement of the law; Fourth sentence: To the extent that this proposed finding states that Respondent did not

prescribe Plegine and Didrex for concomitant use, it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

260-262. Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing than findings of fact.

263. To the extent that this proposed finding states that Respondent did not prescribe Plegine and Didrex for concomitant use, it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

264-268. Accepted and incorporated in substance.

269. Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact.

270-271. Accepted and incorporated in substance.

272-273. Rejected as findings of fact because they are more in the nature of legal argument.

1. Accepted and incorporated in substance.

2. Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact.

3. Accepted and incorporated in substance.

4. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Remaining sentences: Accepted and incorporated in substance.

278-282. Accepted and incorporated in substance.

283. Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact.

284-290. Accepted and incorporated in substance.

1. Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing and argument relating to such evidence than a finding of fact.

2. Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

293-295. Accepted and incorporated in substance.

296. Not incorporated in this Recommended Order because, even if true, it would not alter the outcome of the instant case.

297-307. Accepted and incorporated in substance.

1. To the extent that this proposed finding states that the referenced drugs "are not contra-indicated for any anesthetic, including Ketamine," it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact.

2. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence, before first comma: Accepted and incorporated in substance; Second sentence, after first comma: Not incorporated in this Recommended Order because, even if true, it would not alter the outcome of the instant case.

310-311. Accepted and incorporated in substance.

1. Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact.

2. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: Accepted and incorporated in substance.

314-316. Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing than findings of fact.

317. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact.

318-323. Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing than findings of fact.

324-325. Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing and argument regarding the weight to be given such evidence than findings of fact.

1. To the extent that this proposed finding states that "Ketamine is a safe and appropriate drug to assist in medication-assisted psychotherapy" and that "Respondent did not improperly administer Ketamine treatments to the patient," it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

2. Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact.

3. First sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the weight to be given evidence adduced at hearing; Second and fourth sentences: Not incorporated in this Recommended Order because they would add only unnecessary detail to the factual findings made by the Hearing Officer; Third and fifth sentences: Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing than findings of fact.

329-340. Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing than findings of fact.

341. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: To the extent that this proposed finding states that C.R. visited Respondent's office on two separate occasions on March 8, 1985, it has been rejected because it lacks sufficient evidentiary support. To the extent that it states that C.R. received electric current therapy on March 8, 1985, and later that same visit Ketamine was administered (but not in conjunction with the electric current therapy), it has been accepted and incorporated in substance.

342-346. Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing than findings of fact.

1. To the extent that this proposed finding states that "Respondent did not administer electroconvulsive therapy to the patient" and that he used "the letters 'E.C.T.'" in his medical records on C.R., it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

2. To the extent that this proposed finding states that "Respondent, at no time, inappropriately administered Ketalar in conjunction with electroconvulsive therapy treatment" and that "Respondent never inappropriately administered Ketamine, and never administered electroconvulsive therapy," it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

3. To the extent that this proposed finding states that "amphetamines were never prescribed" and Respondent did not "inappropriately and excessively"

prescribe benzodiazepines, it has been accepted and incorporated in substance. To the extent it states that barbiturates were used "only on one occasion," it has been rejected because it lacks sufficient evidentiary support. Otherwise, it has been rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

350-353. Accepted and incorporated in substance.

354. Not incorporated in this Recommended Order because it would add only unnecessary detail to the factual findings made by the Hearing Officer.

355-363. Accepted and incorporated in substance.

364-369. Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing than findings of fact.

1. To the extent that this proposed finding states that "there was no inappropriate or excessive prescription of Benzodiazepines, and that there were no inappropriate or excessive prescriptions of barbiturates, amphetamines, benzodiazepines, or Ketamine," it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

2. First sentence: Accepted and incorporated in substance; Second and third sentences: Rejected as findings of fact because they are more in the nature of argument regarding the sufficiency of the evidence.

3. First sentence: Accepted and incorporated in substance; Second sentence: To the extent that this proposed finding states that Respondent administered non-convulsive, as opposed to convulsive, electric current therapy to C.R., it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

4. First and third sentences: Rejected as findings of fact because they are more in the nature of argument regarding the sufficiency of the evidence; Second sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact.

5. First and second sentences and third sentence, before second comma: Accepted and incorporated in substance; Third sentence, after second comma: Rejected because it lacks sufficient evidentiary support; Fourth sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

6. Accepted and incorporated in substance.

7. To the extent that this proposed finding states that "electroconvulsive therapy was not administered by the Respondent to this patient," it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

8. First sentence: Accepted and incorporated in substance; Remaining sentences: Rejected as findings of fact because they are more in the nature of argument regarding the sufficiency of the evidence.

9. To the extent that this proposed finding states that Respondent had reason to believe that C.R. did not have an addictive or abusive personality, it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

10. Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact.

380-381. To the extent that these proposed findings state that Respondent had reason to believe that C.R. did not have an addictive or abusive personality, they have been accepted and incorporated in substance. Otherwise,

they have been rejected as findings of fact because they are more in the nature of argument regarding the sufficiency of the evidence.

1. Accepted and incorporated in substance.

2. First sentence: To the extent that this proposed finding states that Respondent "never administered electroconvulsive therapy to the patient," it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of legal argument; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

3. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

385-386. Rejected as findings of fact because they are more in the nature of legal argument.

1. First sentence: To the extent that this proposed finding states that Respondent did not treat C.R.'s rectal fissure, it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence; Remaining sentences: Rejected as findings of fact because they are more in the nature of summaries or descriptions of evidence adduced at hearing and argument relating to such evidence than findings of fact.

2. First sentence: Rejected as a finding of fact because it is more in the nature of a summary or description of evidence adduced at hearing than a finding of fact; Second sentence: To the extent that this proposed finding states that Respondent did not treat C.R.'s rectal fissure, it has been accepted and incorporated in substance. Otherwise, it has been rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

3. Rejected as a finding of fact because it is more in the nature of legal argument.

4. Rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

391-392. Accepted and incorporated in substance.

1. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

2. Accepted and incorporated in substance.

3. First, second and third sentences: Accepted and incorporated in substance; Fourth sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the sufficiency of the evidence.

4. First sentence: Accepted and incorporated in substance; Remaining sentences: Rejected as findings of fact because they are more in the nature of argument regarding the sufficiency of the evidence.

COPIES FURNISHED:

Kenneth J. Metzger, Esquire Agency for Health Care

Administration

1940 North Monroe Street Suite 60

Tallahassee, Florida 32399-0792

Joseph S. Geller, Esquire

Sheraton Design Center Office Plaza Suite 403

1815 Griffin Road

Dania, Florida 33004

Dr. Marm Harris, Executive Director Board of Medicine

Agency for Health Care Administration

1940 North Monroe Street Tallahassee, Florida 32399-0792

Harold D. Lewis, Esquire General Counsel

Agency for Health Care Administration

The Atrium, Suite 301

325 John Knox Road Tallahassee, Florida 32303

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions to this recommended order. All agencies allow each party at least 10 days in which to submit written exceptions. Some agencies allow a larger period of time within which to submit written exceptions. You should contact the agency that will issue the final order in this case concerning agency rules on the deadline for filing exceptions to 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: 91-002811

Orders for Case No: 91-002811