Findings Of Fact The Respondent is a licensed physician in the state of Florida, and holds license number ME 0034710. Respondent's last known address is 1430 Mason Avenue, Daytona Beach, Florida, 32117-4551. At all times material to these proceedings, Respondent, who is both a neurologist and a psychiatrist, specialized in the diagnosis and treatment of headaches in his medical practice with Daytona Neurological Associates in Daytona Beach, Florida. At various times from approximately May 18, 1984, through December 23, 1988, Respondent rendered neurological care to Patient C.R., a female born on November 14, 1963. On May 18, 1984, when C.R. initially came to Respondent's office complaining of severe headaches, Respondent noted in his medical records that the patient had been on birth control pills for three years and had ceased taking them two months prior to this visit. C.R. was also a cigarette smoker. From approximately May 18, 1984, until September 12, 1986, C.R. was prescribed a variety of medications at various times by Respondent for the patient's headaches. The medications included Asendin, Phrenilin Forte, Norpramin, and Tylenol #3. Medrol, Prednisone, and Decadron are legend drugs as defined in Section 465.003, Florida Statutes, and contain both natural and synthetic adrenocortical steroids (glucocorticoids). On September l2, 1986, Respondent prescribed a Medrol Dosepak unit to C.R. A Medrol Dosepak is a corticosteroid specific package that is tapered over six days from the first dose down to the last dose and contains a total of 84 mg of methylprednisolone (105 mg Prednisone equivalent). The medication was concluded on or about September 17, 1986. On October 30, 1986, Respondent prescribed another Medrol Dosepak unit to C.R. The patient took the Medrol tablets beginning on this date, in decreasing dosages, starting at 24 mg and ending at 4 mg six days later, for a total of another 84 mg of methylprednisolone (105 mg Prednisone equivalent). Both prescriptions of Medrol (September 12, 1986 and October 30, 1986) were short courses and treatment was not inappropriate. On November 7, 1986, C.R. went to a hospital emergency room where she was prescribed Prednisone 40 mg for three days and 20 mg for four days and referred back to the Respondent for follow-up care. During this hospitalization, C.R. received approximately 200 mg of Prednisone. On November 14, 1986, Respondent saw C.R. in his office and indicated in his records that the patient seemed to be doing better on Prednisone and "[w]e will keep her on this medication and re-evaluate her in one month. She is to . . . decrease the Prednisone and come off this in about a week or two." On November 25, 1986, Respondent saw C.R. in his office. Respondent indicated in his records that he would keep C.R. on Prednisone l0 mg daily for "another week or so." From November 7, 1986 until November 30, 1986, C.R. received a total of 465 mg of Prednisone. Appropriateness of corticosteroid use varies with both amount and duration. The amount initiated in the Emergency Room on November 7, 1986, was not excessive, but Respondent's rationale for continuation of the drug, or whether the November 14, 1986 dosage was tapered or less than that previously prescribed for C.R. in the emergency room, is not documented in Respondent's patient records. On January 20, 1987, Respondent saw C.R. in his office and documented that he was going to give the patient another "short course" of Prednisone. Respondent saw C.R. again in his office on January 30, 1987, and documented further prescription of Prednisone. The documentation for the above two visits does not indicate the dosage details nor suggest what circumstances of the patient's condition justify again prescribing prednisone other than the remark dated January 20, 1987, that "[p]atient is having some headaches again." For the period of January 20, 1987 through February 9, 1987, C.R. was prescribed a total of 510 mg of Prednisone. Petitioner's Exhibit 5 is a calendar prepared by C.R. which allegedly documents the patient's receipts for prescriptions which she purchased upon Respondent's authorization. C.R. has no independent recollection of amounts or times when she took the medications. On the basis of information reflected on the calendar, Petitioner seeks to establish that Respondent prescribed corticosteroids for C.R. in excess of that otherwise established by the evidence in this case. In view of the lack of C.R.'s independent recollection of when she took the medications, the lack of corroborating original receipts, C.R.'s lack of detail recall concerning her treatment by Respondent, her inability to remember when she prepared the calendar other than in preparation for civil litigation against Respondent following her treatment, and lack of other direct evidence corroborating the document's veracity, the calendar standing alone is not credited for the purpose of establishing amounts and times of medication prescribed for C.R. by Respondent. C.R. had an office visit on March 18, 1988 but there is no reference to any Prednisone prescription in the medical record. A handwritten note for the date of April 6, 1988 in the Respondent's medical record states that the patient was "told to stay on Prednisone." Respondent conceded in testimony that he apparently failed to document prescribing 60 mg Prednisone in April of 1988. From April 27, 1988 through May 8, 1988, Respondent had C.R. admitted to Halifax Medical Center in Daytona Beach, Florida. During that period, she received 909 mg. Prednisone equivalent (Decadron). Respondent discharged the patient with a diagnosis of severe vascular migraine headaches under control with a combination of Mellaril and Procardia. At the time of the April, 1988 admission, C.R. was suffering from crescendo migraine with numbness, blurring, and an episode of loss of consciousness. As established by testimony of Thomas M. Zizic, M.D., Respondent's expert in avascular necrosis, corticosteroid use, and treatment of headache, patients with the symptoms displayed by C.R., when she was hospitalized in April of 1988, are at risk for transient ischemic attacks and strokes. As opined by Dr. Zizic, and corroborated by testimony of Victor B. Robert, M.D., the short course of less than two weeks of high dose steroids in the course of the April, 1988 hospitalization was not inappropriate. Zizic also opined that the other courses of steroids prescribed previously for C.R. were not inappropriate. As established by Zizic, steroid medications in the amounts and duration prescribed for C.R. are not causative of avascular or aseptic necrosis. Dosage amounts of these drugs have to be much greater and for longer periods of time to occasion such side effects. Even assuming C.R.'s calendar of medications and the resultant supposition that she ingested more steroid medication than is established by the credible evidence, Zizic opined that the likelihood that such medication amounts and duration resulted in C.R.'s development of aseptic necrosis is less than five percent. Zizic also testified that he would not have felt it necessary to warn C.R. of the potential for avascular or aseptic necrosis in view of the remoteness of such a possibility at dosages prescribed for her. Dr. Jacob Green, an expert witness presented by Respondent, is a neurologist who provided insight into the clinical management of the difficult headache patient, noting that there is no standard treatment for such patients, "[y]ou just have to use what works . . . Its a matter of trial and error in a lot of cases." Green also noted that once a patient is treated with corticosteroids, the dosages must be tapered gradually, not stopped suddenly. Green concluded C.R.`s dosages were decreased appropriately, that duration of Medrol and Prednisone prescribed for the patient was appropriate, and that use and duration of Decadron during C.R.`s hospitalization in April, 1988, was also appropriate. While Green acknowledged that avascular necrosis of the hips is a known complication of steroid use, he testified that in 1986 or 1987 he would not have felt that failure to warn a patient about the potential for such a remote side effect constituted a breach of the standard of care and would not have warned the patient. In Green's opinion, Respondent did not prescribe Medrol, Prednisone or Decadron contrary to the best interests of C.R. In 1989, C.R. was diagnosed with aseptic necrosis of the femoral head of both her hips and underwent surgery in 1989 and 1990 resulting in total hip replacements. She has undergone surgery for "a revision on the left side" and continues to have problems. While differing expert testimony presented in this proceeding fails to clearly and convincingly establish a causal connection between the steroid medications given to C.R. and her resultant physical problems, the common consensus of those experts is that avascular necrosis is a complication that can arise from the use of steroids, given sufficient dosages and duration of such medication. Although Respondent did not inform C.R. of the potential of avascular necrosis from corticosteroid dosing by the prescribed medications and did not at any time during the course of his treatment discuss with CR the potential for such harmful side effects, the evidence fails to establish that the patient should have been informed in 1986 regarding the remote potential for harmful side effects of such medications. However, Respondent's medical records on the patient C.R. were inadequate. The records did not serve as an effective basis for planning patient care and providing for continuity in the evaluation of the patient's condition and treatment. The records did not furnish documentary evidence of the course of the patient's medical evaluation, treatment, and change in condition. Detail of the records was not sufficient to clearly demonstrate why one course of treatment was undertaken in preference to another course and would not have communicated sufficient information for any other practitioner who would have assumed the patient's care.
Recommendation ACCORDINGLY, it is recommended that a final order be entered finding the Respondent guilty of count two of the Administrative Complaint, violation of Section 458.331(l)(m), Florida Statutes; requiring as a penalty that Respondent's license to practice as a physician in the State of Florida be placed on probation for a period of one year upon conditions prescribed by the Board of Medicine; and further requiring that Respondent pay a fine in the amount of $5,000. DONE and ENTERED this 26th day of February, 1996, in Tallahassee, Leon County, Florida. DON W. DAVIS, 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 26th day of February, 1996. APPENDIX CASE NO. 94-2116 In accordance with requirements of Section 120.59, Florida Statutes, the following constitute my rulings with regard to proposed findings of fact submitted by the parties. Respondent's Proposed Findings. 1.-2. Accepted. Rejected, unnecessary. Rejected, subordinate to HO findings. Accepted, but not verbatim. While the calendar was admitted, it may only be used to corroborate direct testimony. C.R. had no independent recollections which could be corroborated by the calendar. Respondent took issue with the calendar, consequently the calendar is not credited as a basis for fact finding with the exception of Dr. Zizic's opinion regarding dosage levels. Incorporated by reference. 7.-10. Rejected, subordinate to HO findings. 11. Accepted, not verbatim. 12.-15. Incorporated by reference. 16.-18. Accepted. 19.-22. Rejected, subordinate to HO findings. Petitioner's Proposed Findings. 1-4. Accepted. 5. Rejected, unnecessary. 6.-9. Accepted, not verbatim. 10. Accepted in part, remainder rejected as subordinate. 11.-12. Accepted. 13.-19. Rejected, subordinate to HO findings. 20.-22. Accepted. 23.-25. Rejected, subordinate to HO findings. COPIES FURNISHED: Albert Peacock, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Donna J. Torsney, Esquire Donald W. Weidner, P.A. 10161 Centurion Parkway North Suite 190 Jacksonville, Florida 32256 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403 Dr. Marm Harris, Executive Director Agency for Health Care Administration Division of Medical Quality Assurance 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact At all pertinent times, respondent Koa-Shun Wu has been licensed to practice medicine and surgery in Florida. He holds license No. 32315. Dr. Wu trained in Taiwan as a thoracic surgeon. He taught in medical school there and published in his field. When Dr. Wu emigrated to the United States, he hoped to obtain a surgical residency here. Not finding such a position, he took a job at Polk General Hospital in Lakeland as a house physician, then worked as a staff physician in Polk General Hospital's ambulatory care center. In the spring of 1981, Dr. Wu began a general practice near Winter Haven, about 40 miles from Tampa. This lasted some fifteen months. His wife worked with him in the office but it was hard making a go of it financially and, in August of 1982, he closed the practice in order to take his present job at the Florida State Hospital in Chattahoochee. His professional reputation there is good. On April 13, 1982, a 29-year-old woman giving her name as Jennifer Gail Jones presented herself at Dr. Wu's office saying she needed a Pap smear because she was going to join a methadone program in Tampa. She returned on April 28, 1982, complaining of the frequency of her micturition and of discomfort when she urinated. Dr. Wu performed a physical examination and diagnosed a urinary tract infection. On that visit, according to his office records, in addition to dispensing medicine for this infection, Dr. Wu prescribed 50 milligrams of methadone "daily P.R.N,," a total of 30 ten milligram tablets. Joint Exhibit B. Other testimony established that five milligram methadone tablets, but not ten milligram methadone tablets, were available at local pharmacies. Depositions of Fox, Garrett. Perhaps this was communicated to Dr. Wu who wrote a revised prescription. In any event, the prescription that was filled for Jennifer G. Jones on April 28, 1982, was for 60 five milligram methadone tablets and the dosage prescribed was "fifty mg. p. o. daily in A.M." Joint Exhibit R. Dr. Wu wrote this prescription for methadone, his first, after the patient told him she had enrolled in a methadone maintenance program in Tampa on April 12, 1982. (This did not gibe precisely with her statement on her initial visit on April 13 that she was "going to join" at that time.) She said she was receiving 50 milligram doses daily at the Tampa clinic but that some days she could not go to Tampa because she had to work in Winter Haven. Dr. Wu took her at her word and acted to make the same dose available to her on days she did not get to the clinic as she received when she made the trip there. With this straightforward and arguably reasonable step, the die was cast. For this same patient, respondent prescribed an additional 30 five milligram tablets on May 5, 1982, with a prescribed dosage of 20 milligrams every other day and, on May 17, 1982, 40 five milligram tablets at the same dosage. On May 28, 1982, respondent prescribed 24 five milligram tablets to be taken twice daily "on days not going to Tampa clinic." On June 8 and 17, and July 21, 1982, respondent wrote prescriptions for Jennifer Jones, each for 24 five milligram methadone tablets, and each at the dosage of 30 milligrams every other day. (Counts Sixteen, Seventeen and Eighteen) Word spread among other clients of the Tampa methadone program and reached a heroin addict who had not enrolled in a methadone maintenance program, as well. The latter, Mary Joyce Strouse, lied to Dr. Wu on this point. On May 3, 1982, she told him that she had enrolled in the Tampa program a year earlier and that she was receiving 35 milligrams of methadone daily at the clinic. On May 29, June 9 and 25, July 9, 16 and 29 and August 5, 1982, Dr. Wu wrote methadone prescriptions for her. Each was for 24 five milligram tablets and the prescribed dosage was 30 milligrams every other day, except for the first prescription which was 15 milligrams every other day, "P.R.N." or "if not go to Tampa clinic." Joint Exhibit R. Ms. Strouse took the methadone so she "wouldn't have to buy street dope." Deposition of Ms. Strouse, p.10. (Counts Twenty-two, Twenty-three and Twenty-four) Respondent wrote all eleven of the methadone prescriptions for Ralph B. Strouse alleged in Count One. On Mr. Strouse's initial visit, respondent performed a physical examination and took his history, and, on another visit, he removed a bullet lodged in his thigh. He treated various other ailments as well. (Count One, Two and Three) Respondent wrote the seven methadone prescriptions for Voncil Frank Woodrow Snider alleged in Count Four. On the initial visit, he performed a physical examination, and concluded that Mr. Snider was mildly hypertensive and mildly obese. Respondent wrote the four methadone prescriptions for Frankie A. Bailey a/k/a Frankie Smith alleged in Count Seven, the methadone prescription for Angel Reel alleged in Count Ten, the nine methadone prescriptions for Wayne Hoskins alleged in Count Thirteen, the four methadone prescriptions for Henry M. Cain a/k/a Michael Cain alleged in Count Nineteen, the four methadone prescriptions for Deborah Asbel alleged in Count Twenty-five and the latter six of the seven methadone prescriptions for William Asbel alleged in Count Twenty-Eight. Except for Mary Joyce Strouse and Voncil Frank Woodrow Snider, the patients for whom Dr. Wu prescribed methadone participated in a Tampa methadone maintenance program. (Mr. Snider participated in such a program in Orlando.) The Tampa participants were not told what their methadone dosages were. The levels they reported to Dr. Wu were speculation at best. On several occasions Dr. Wu asked for and received receipts from the methadone maintenance clinics indicating current participation, but he did not always do this, and he never telephoned or otherwise contacted either clinic. In all, he wrote some 60 prescriptions for ten people. He charged $20 for an initial office visit and $15 per office visit thereafter. There was no surcharge for methadone prescriptions. (He charged $125 to remove the bullet from Mr. Strouse's thigh.) More than once, Mr. Fox, the pharmacist, telephoned and questioned respondent about the propriety of the methadone prescriptions. At least one patient recalled Dr. Wu's consulting a copy of the Physicians' Desk Reference. Every prescription he wrote after May 20, 1982, (and all but three of the total) was for 24 five milligram tablets. The 1983 Physicians' Desk Reference has this to say about methadone, which is sold under the trade name Dolophine Hydrochloride: CONDITIONS FOR DISTRIBUTION AND USE OF METHADONE PRODUCTS: Code of Federal Regulations. Title 21. Sec. 291.505 METHADONE PRODUCTS. WHEN USED FOR THE TREATMENT OF NARCOTIC ADDICTION IN DETOXIFICATION OR MAINTENANCE PROGRAMS, SHALL BE DISPENSED ONLY BY APPROVED HOSPITAL PHARMACIES, APPROVED COMMUNITY PHARMACIES, AND MAINTENANCE PROGRAMS APPROVED BY THE FOOD AND DRUG ADMINISTRATION AND THE DESIGNATED STATE AUTHORITY. APPROVED MAINTENANCE PROGRAMS SHALL DISPENSE AND USE METHADONE IN ORAL FORM ONLY AND ACCORDING TO THE TREATMENT REQUIREMENTS STIPULATED IN THE FEDERAL METHADONE REGULATIONS (21 CFR 291.505). FAILURE TO ABIDE BY THE REQUIREMENTS IN THESE REGULATIONS MAY RESULT IN CRIMINAL PROSECUTION, SEIZURE OF THE DRUG SUPPLY, REVOCATION OF THE PROGRAM APPROVAL, AND INJUNCTION PRECLUDING OPERATION OF THE PROGRAM. A METHADONE PRODUCT, WHEN USED AS AN ANALGESIC, MAY BE DISPENSED IN ANY LICENSED PHARMACY. Indications: (See Note below.) For relief of severe pain. For detoxification treatment of narcotic addiction. For temporary maintenance treatment of narcotic addiction. NOTE If methadone is administered for treatment of heroin dependence for more than three weeks, the procedure passes from treatment of the acute withdrawal syndrome (detoxification) to maintenance therapy. Maintenance treatment is permitted to be undertaken only by approved methadone programs. This does not preclude the maintenance treatment of an addict who is hospitalized for medical conditions other than addiction and who requires temporary maintenance during the critical period of his stay or whose enrollment has been verified in a program which has approval maintenance treatment with methadone. Contraindication: Hypersensitivity to methadone. Warnings: Methadone hydrochloride, a narcotic, is a Schedule II controlled substance under the Federal Controlled Substances Act. Appropriate security measures should be taken to safeguard stocks of methadone against diversion. DRUG DEPENDENCE--METHADONE CAN PRODUCE DRUG DEPENDENCE OF THE MORPHINE TYPE AND, THEREFORE, HAS THE POTENTIAL FOR BEING ABUSED. PSYCHIC DEPENDENCE, PHYSICAL DEPENDENCE, AND TOLERANCE MAY DEVELOP UPON REPEATED ADMINISTRATION OF METHADONE, AND IT SHOULD BE PRESCRIBED AND ADMINISTERED WITH THE SAME DEGREE OF CAUTION APPROPRIATE TO THE USE OF MORPHINE. Adverse Reactions: THE MAJOR HAZARDS OF METHADONE. AS OF OTHER NARCOTIC ANALGESICS, ARE RESPIRATORY DEPRESSION AND, TO A LESSER DEGREE, CIRCULATORY DEPRESSION. RESPIRATORY ARREST, SHOCK, AND CARDIAC ARREST HAVE OCCURRED. Dosage and Administration: For Relief of Pain--Dosage should be adjusted according to the severity of the pain and the response of the patient. Occasionally it may be necessary to exceed the usual dosage recommended in cases of exceptionally severe pain or in those patients who have become tolerant to the analgesic effect of narcotics. For Detoxification Treatment--THE DRUG SHALL BE ADMINISTERED DAILY UNDER CLOSE SUPERVISION AS FOLLOWS: A detoxification treatment course shall not exceed 21 days and may not be repeated earlier than four weeks after completion of the preceding course. In detoxification, the patient may receive methadone when there are significant symptoms of withdrawal. The dosage schedules indicated below are recommended but could be varied in accordance with clinical judgment. Initially, a single dose of 15 to 20 mg. of methadone will often be sufficient to suppress withdrawal symptoms. Additional methadone may be provided if withdrawal symptoms are not suppressed or if symptoms reappear. When patients are physically dependent on high doses, it may be necessary to exceed these levels. Forty mg./day in single or divided doses will usually constitute an adequate stabilizing dosage level. Stabilization can be continued for two to three days, and then the amount of methadone normally will be gradually decreased. The rate at which methadone is decreased will be determined separately for each patient. The dose of methadone can be decreased on a daily basis of at two-day intervals. But the amount of intake shall always be sufficient to keep withdrawal symptoms at a tolerable level. In hospitalized patients, a daily reduction of 20 percent of the total daily dose may be tolerated and may cause little discomfort. In ambulatory patients, a somewhat slower schedule may be needed. If methadone is administered for more than three weeks, the procedure is considered to have progressed from detoxification or treatment of the acute withdrawal syndrome to maintenance treatment, even though the goal and intent may be eventual total withdrawal. Overdosage: Symptoms--Serious overdosage of methadone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, maximally constricted pupils, skeletal-muscle flaccidity, cold and clammy skin, and, sometimes, bradycardia and hypotension. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. The foregoing appears under the heading "AMPOULES AND VIALS" to which a reader consulting the "Tablets" Section is referred. In each instance, Dr. Wu undertook maintenance and/or detoxification treatment of narcotic addicts, as opposed to prescribing methadone as an analgesic. Prescriptions for analgesic purposes by an oncologist in the Winter Haven area were for greater quantities (100 tablets) than Dr. Wu prescribed. As a matter of policy, maintenance doses at the Tampa clinic do not exceed 50 milligrams daily but there was testimony that 80 milligrams a day at another clinic in the area was not uncommon and that maintenance doses of 100 or even 120 milligrams, are not unheard of. Dr. Wu referred to Goodman's Textbook of Pharmacology (1980) which states: "Subjects who are maintained on daily oral doses of 100 mg. of methadone for more than 8 weeks still seem sedated and apathetic . . . [but] sedation and apathy are easily managed by reductions in dosage." At 547. Elsewhere the same text states, in reference to methadone maintenance: "Most commonly the procedure consists in the daily administration of 40 to 100 mg. of methadone . . ." At 574. Physicians who treat heroin addiction do not prescribe methadone even when urinalysis reveals the presence of an opiate, unless they observe objective signs (goose bumps, rhinorrhea, elevated blood pressure, body temperature, and pulse rate, etc.) corroborating reported symptoms of withdrawal. They want objective proof of addiction, not just use, before prescribing a maintenance dose of methadone, although they rely on the addict's subjective symptoms to some extent in calibrating the dosage. When the initial dose of methadone is administered, the addict is observed for a half hour, against the possibility of some adverse reaction. After the magnitude of the maintenance dose is determined, it may remain unchanged for months or years. Only when an addict and his counselor agree that there is hope for turning over a new leaf does therapeutic detoxification, the gradual diminution of the methadone dose, occur. Administrative or punitive detoxification, a relatively rapid decrease in dosage, may occur if an addict fails to abide by the rules of the maintenance program by, for example, ingesting or injecting addictive substances other than methadone. Urine samples are regularly taken from persons in methadone maintenance programs and analyzed for evidence of extracurricular drug use. Such analysis can detect the use of heroin but does not ordinarily reveal extra doses of methadone. From the standpoint of an addict who seeks some analgesic or euphoric effect, additional methadone is the ideal way to augment what the clinic prescribes. Partly for this reason, methadone maintenance programs require, at least initially, that their clientele appear personally for each dose, which is administered on the premises. This practice also makes continuity in counseling and urine screening more likely, and minimizes the danger of methadone reaching somebody for whom it was not intended. As time goes on, the program client may be entrusted with one or more "take homes," doses he is to administer to himself off the premises. It is not acceptable practice to give somebody on another maintenance program a dose of methadone without communicating with the people operating the other program. Paragraph 291, Title 21 of the Code of Federal Regulations spells out in detail the legal restrictions that federal law places on methadone maintenance programs. Neither a private medical practitioner nor any other person or organization can lawfully prescribe methadone for a patient for more than three days without being approved as a methadone treatment program by the health authorities. Dr. Wu never sought nor obtained such approval. Methadone is a Schedule II narcotic, a synthetic central nervous system depressant with effects like that of morphine. Dr. Wu testified without contradiction that be believed that the DEA license which he held at all pertinent times authorized him to prescribe all Schedule II narcotics, and that the legal restrictions on dispensing methadone that appeared in the Physicians' Desk Reference did not apply to DEA license holders like himself. These beliefs, were and are erroneous. Goodwin's Textbook of Pharmacology (1980) states: "In the United States, special controls on methadone have been enacted. . . " At 519. When Dr. Wu closed his office, the only notice he gave his patients was posted on the door at the office at the time he left.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner suspend respondent's license for three months, but stay the suspension, on condition that respondent successfully complete two years' probation during which probation he be forbidden to prescribe controlled substances and be required to take at least fifty (50) hours of continuing professional education pertaining to controlled substances. DONE and ENTERED this 19th day of January, 1984, in Tallahassee, Florida. ROBERT T. BENTON II Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 19th day of January, 1984. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Melissa Fletcher Allaman, Esquire and Wilfred C. Varn, Esquire Ervin, Varn, Jacobs, Odom & Kitchen Post Office Box 1170 Tallahassee, Florida 32302-1170 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
Findings Of Fact The Respondent, Solomon D. Klotz, M.D., at all times pertinent hereto, has held a current, valid medical license number ME 0002269, issued by the Board of Medical Examiners, Department of Professional Regulation, which is the agency charged with enforcing Chapter 458, the "Medical Practice Act," as it relates to qualification for licensure and standards for regulating medical practice of physicians licensed in the State of Florida. The Respondent is also board- certified by the American Board of Internal Medicine in internal medicine and is board- certified in the field of allergy and immunology by the American Board of Allergy and Immunology. The Respondent obtained his M.D. Degree from New York Medical College in 1937, obtaining a Masters from that institution in 1942. He was licensed in New York in 1938 and was made a diplomate of the National Board of Medical Examiners in 1938. He was issued his Florida license in 1941. He served in the Medical Corps of the United States Army in World War II and during the years 1945 and 1946 was a clinical instructor at New York Medical College, and a research fellow at Metropolitan Hospital Research Unit in New York. The Respondent has practiced in his specialty field of internal medicine as well as allergy and immunology in Florida for many years. He is presently a clinical professor at the College of Health of the University of Central Florida, and an adjunct professor at the Department of Biological Sciences at the University of Central Florida. Respondent is presently on the medical staffs at Winter Park Memorial Hospital, Florida Hospital, Orlando Regional Medical Center and Humana Hospital/Lucerne, with a senior consultant rating at each of the above hospitals. The Respondent is a member of 21 professional societies and was a founding member of the Salk Institute for Biological Studies and, the board of the Joint Council of Allergy and Immunology. He has served as president of the American College of Allergists, the Florida Allergy Society, Southeastern Allergy Society, and is president of the medical staff of Florida Hospital in Orlando. The Respondent has published or presented more than 50 research papers, seven of which have been published within the past three years in such journals as the Annals of Allergy, the Journal of the Florida Medical Association, the Journal of the American Academy of Allergy and Immunology and the American Heart Journal. Concerning the disease or condition most pertinent to the charges in the administrative complaint, the Respondent published a paper jointly with Dr. Von Hilsheimer in 1970 concerning minimal brain dysfunction, attention disorders and the diagnosis of functional narcolepsy. Dr. George Von Hilsheimer was accepted as Respondent's expert witness concerning the diagnosis of narcolepsy and the various forms or manifestations of narcolepsy and the treatment thereof. He is a licensed psychologist in the State of Florida, having been educated at the University of Miami with postgraduate work at the University of Chicago. He interned in psychology at the Corsack Clinic and the Seabrook Institute in San Francisco. He completed his Ph.D. in psychology with a multiple major in neuropsychology, psychoimmunology and psychotherapy. He is an associate fellow in the Society for Clinical Ecology, a consultant to the Science Advisory Committee of the Environmental Protection Agency as a neuropsychologist and behavioral toxochologist. He is eligible for board certification by the Academy for Psychosomatic Medicine and the American Academy of Behavioral Medicine. He has published numerous reference papers and a number of books, one of which books focused on the diagnosis of minimal brain dysfunction and the issue of psychosomatic versus somatic causes for behavior. He has presented two papers in conjunction with the Respondent on the issue of minimal brain dysfunction, tension disorders and the diagnosis of functional narcolepsy. Since 1980, Dr. Von Hilsheimer's practice has been split between psychotherapy and psychoimmunology. In the past ten years he has presented numerous continuing education workshops for physicians, which courses were certified by the American Medical Association. Dr. Dale K. Lindberg, M.D., was accepted as an expert witness for the Petitioner regarding the pharmacological effects, uses and indications of the drugs related to the charges in the administrative complaint. Dr. Lindberg has been a licensed physician in the State of Florida since 1959. He is board certified in nuclear medicine. He took a residency in nuclear medicine at Mt. Sinai Hospital in Miami Beach between the years 1974 and 1977. Since 1973, his practice has been limited to primarily that of supervising methadone maintenance programs and clinics. Prior to 1973 his practice was in the area of family practice, as well as nuclear medicine. He is a member of the Broward County Medical Association, Florida Medical Association, American Medical Association, Broward County Family Practice Association, as well as the Society of Nuclear Medicine. Dr. Lindberg has never treated a patient with narcolepsy nor has he seen patients exhibiting the various kinds of narcoleptic behavior. METHAQUALONE PRESCRIPTIONS; COUNTS I, II AND III The first three counts in the administrative complaint concern prescriptions written June 24, 1982, for allegedly excessive and unjustified amounts of a controlled substance, methaqualone, prescribed to patients Harri Klotz (Count I) , Sam Meiner (Count II) and Charles Meiner (Count III). Those prescriptions consisted of 121 sopor (150 mgs) for Harri Klotz; 189 parest for Sam Meiner; and 34 quaaludes for Charles Meiner, all of which are methaqualone medications. The Respondent received a telephone call on or shortly before June 24, 1982, the date the prescriptions were written, from a pharmacist whom he regularly dealt with, who informed him that, inasmuch as, effective July 1, 1982, he would be unable to fill methaqualone prescriptions due to a change in the law by which it became a Schedule I drug, that he would make available the small quantity of methaqualone remaining in stock to the Respondent for his patients who required the drug. The Respondent acknowledged having a few such patients and accordingly wrote prescriptions for the above odd numbers of capsules to patients whom had been regularly receiving methaqualone medication for a period of time previously. Patient Harri Klotz is the Respondent's wife. She has been a patient of Respondent since approximately 1940. She suffers from generalized osteo- arthritis involving mainly the hips, which was first diagnosed in 1967. Due to progressive severity of the disease she received surgery in October, 1970, in Germany, for replacement of both hip joints with artificial prosthesis. Since that time the right hip prosthesis joint cracked, causing her severe, chronic pain which caused her great difficulty in sleeping. After taking numerous combinations of medicine, Mrs. Klotz was found to respond most effectively to methaqualone, which induced sleep in spite of the pain, without undesirable side effects the next morning. She ultimately had the right hip prosthesis repaired. Her medical records indicate that this medication had also been prescribed for her by her treating physicians when the prosthetic devices were implanted. In 1981 she again began experiencing the same type of agonizing, chronic pain in her left hip and consulted an orthopedic surgeon at regular intervals concerning it. It was not until November, 1952, however, that the diagnosis was made that her left prosthesis had also broken. During the various attempts to diagnose the cause of this problem with her left hip, she was experiencing severe, chronic pain. Finally, after a third stint of surgery the left hip prosthesis was replaced and her symptoms ultimately improved. In the meantime however, on October 14, 1981, Respondent purchased 1,000 quaaludes for his wife. He did not dispense the entire lot to her, rather she was given 30 capsules at a time for use in inducing sleep during the period when she suffered from her painful condition at intervals of one and one-half to two months. The Respondent carefully monitored her dosage and kept the balance under lock and key at his office, duly recording on a dispensing record the capsules actually given to his wife on each occasion. On June 24, 1982, before methaqualone became a Schedule I Controlled Substance, he last prescribed that substance for his wife when he wrote the prescription for 121 sopor. He has not since prescribed a methaqualone substance to his wife. On June 24, 1982, the Respondent prescribed methaqualone to Sam Meiner. Mr. Meiner (Respondent's counsel) has been a patient of the Respondent since approximately 1968. Be suffers from a severe, chronic painful condition called regional enteritis, a condition characterized by severe, chronic pain and acute bowel spasms associated with acute exacerbations of the enteritis condition. As a result of this condition he has had two bowel resection surgeries, during the course of which surgeons removed approximately six feet of his small intestine. He has suffered from this disease chronically for approximately 18 years, having his first surgery in 1967 and the second in 1977. "hen the enteritis condition became acutely inflamed after his second surgery, he once again sought Respondent's medical advice. He has been a continuous patient of the Respondent ever since that time, seeing him almost on a weekly basis. Included in the total medical care Respondent has given this patient is a prescription of methaqualone for its beneficial soporific and antispasmodic effects designed to curtail the severity and duration of the bowel spasm incidents. Other physicians, as well as Respondent, in treating this patient have attempted many other combinations of medications before the Respondent and patient determined that methaqualone was the most effective modality. Since being under the Respondent's care with attendant methaqualone medication, the patient has required no hospitalization and has been able to lead a substantially normal existence, even though this disease or condition if unsuccessfully treated can ultimately prove fatal, especially if additional such surgical procedures are resorted to. Witness Meiner was shown to have no abnormal adverse effects nor physical or psychological dependence on the drug. It is now no longer legally obtainable, the patient being afforded his last prescription therefor on June 24, 1982, some six days before the prescription of the drug became illegal. On June 24, 1982, the Respondent prescribed 34 methaqualone capsules to Charles Meiner. Charles Meiner (also counsel for Respondent) suffers from a chronic, severe back injury involving a ruptured or degenerative disc. He periodically suffers excruciating, chronic back pain, resulting in his inability to sleep. He has been a patient of the Respondent since 1969. In 1973 he required hospitalization due to the severity of the back pain. lie has seen the Respondent for this problem at regular intervals ever since. He had been prescribed methaqualone on a number of occasions prior to June, 1982, as the medication helps his insomnia resulting from the chronic back pain, without imposing any adverse effect the following morning or inhibiting his ability to function in the legal profession. Be has never taken more than one tablet per day and some days only a half tablet during the course of his back pain flare- ups. In May of 1982, his back condition became particularly severe, with persistent pain. Because of this exacerbation of his back condition, he was given a prescription for 34 quaalude tablets on June 24, 1982, to relieve his pain and enable him to sleep. During the time Respondent prescribed methaqualone to these three above-named patients, methaqualone was an acceptable medication for relief of the symptoms these patients exhibited. Petitioner's witness Dr. Lindberg acknowledged that the prescribing of methaqualone by the Respondent to these patients on or before July 1, 1982, was for a medically justifiable purpose, and that the dosages involved were within recommended daily dosages for the treatment of the symptoms exhibited by these patients, as depicted in the Physician's Desk Reference (PDR) a work relied on by both parties throughout this proceeding. AMPHETAMINE PRESCIPTIONS: COUNTS IV, V, VII, XI, XII, XIII, XIV, XVI, XVII, XVIII and XIX. The prescription of amphetamines became restricted as to use by the enactment of Section 458.331(1)(cc) , Florida Statutes, effective August 30, 1980. This restricted the prescription of any drug which is an amphetamine or a sympathomimetic amine drug (a Schedule II drug) except, as pertinent here, for the condition of narcolepsy. Prior to the restriction of the drug, the Respondent had prescribed such drugs for short-term use for patients who were attempting to embark on a successful weight-control program. The Petitioner's expert witness, Dr. Lindberg, acknowledged that this was a medically appropriate use of this type of medication at the time and that he himself had made similar prescriptions for similar purposes. The Respondent conceded that as of July 3, 1980, that he was not aware of the change in the legal status of amphetamine type drugs by the enactment of the above statute, and did not become aware of such restrictions until the pharmacist with whom he regularly dealt informed him that he could not prescribe Biphetamine, Dexedrine or other sympathomimetics unless the patient had a narcoleptic condition. Upon becoming aware of this restriction after August 30,1980, the Respondent discontinued use of those drugs except for the treatment of narcoleptic symptoms in patients. Dr. Lindberg opined that the only type of narcolepsy he would recognize was "ideopathic narcolepsy." By this he meant that he would only diagnose narcolepsy when all four recognized symptoms are present: excessive daytime sleepiness, cataplexy (a condition when muscles become limp) , hypnogogic hallucinations (dreams shortly before going to sleep or upon awakening) and sleep paralysis whereby the patient is unable to move, although the limbs are not rigid. Dr. Lindberg has never treated a patient with narcolepsy nor has he ever observed a patient exhibit narcoleptic behavior in his practice. Both the Respondent and Dr. Von Hilsheimer, the Respondent's expert witness on the subject, have studied and treated this condition and published recognized research papers on the subject of narcolepsy. Further, the Respondent in connection with his speciality in the field of allergies, has performed testing regarding patients with certain food sensitivities and has observed that some of them will exhibit narcoleptic symptoms as a reaction to certain foods. Dr. Von Hilsheimer, as delineated above, has extensive experience in the diagnosis and treatment of narcolepsy in its various forms and in teaching recognition of the condition to doctors through continuing education courses. Idiopathic narcolepsy, the extreme or classic view of the disease, may involve exhibition of all four of the above symptoms in a patient, however, only 10 percent of patients legitimately diagnosed as narcoleptic present all four symptoms, and therefore most of the scientific and medical community uses the term "narcolepsy" In a broader, more general sense to mean essentially excessive, inappropriate daytime sleepiness, especially at inappropriate times. In addition to narcolepsy being a primary affliction, it can also be a subsyndrome, or secondary disorder related to a different medical problem. It can be permanent or can be a transient condition and can be a by-product of unusual psychological or physical stress. The Respondent prescribed a small dosage of an amphetamine for Nina Balabon between January 11, 1980, and September 17, 1982, at various times. (Count IV) Ms. Balabon is a 92 year old woman who has been taking a very small dosage of Dexedrine for many years. The dosage is substantially below that allowable for such a patient as conceded by the Petitioner and delineated in the Physician's Desk Reference. Ms. Balabon lives alone in Woodstock, New York, and is the foster mother of the Respondent's wife. She had been under the care of another physician who prescribed this course of treatment and drug for her so that she could remain alert enough to independently function and take care of herself in her own home. She is home-bound and after her doctor's death, she was unable to secure another doctor who would make house calls. She called upon the Respondent who is, in effect, a family member, and financially supports her, and asked him to prescribe the medication for her, in conjunction with which she retained the services of a visiting nurse. In her old age she has become afflicted with lassitude, inappropriate and excessive daytime sleepiness, depression and a diminished "will to live." The Respondent visits her in Woodstock, New York, periodically and he or his wife, telephone her at least once a week. A visiting nurse checks on her condition weekly and reports to the Respondent on her physical condition. The Petitioner's expert witness, Dr. Lindberg, has never seen this patient, but surmised upon her recorded weight that she is slightly malnourished. Accordingly, he opines that it is inappropriate to give a person with such a condition (slight malnourishment) amphetamines to curb her appetite and provide her "pep." The Respondent, however, did not prescribe amphetamine for this purpose. Be found, in the exercise of his medical judgment that she exhibits definite symptoms of narcolepsy. The dosage is extremely small and the patient is not shown to suffer any adverse effects therefrom. It was not shown that the dosage curbed her appetite, and indeed, Respondent established that the patient is not malnourished. She is a very small, slightly built woman and her mere recorded weight is not an indication in itself of malnourishment such that the prescription involved would be contraindicated. Petitioner's expert witness, further was unaware that the patient exhibited symptoms of narcoleptic behavior, and admitted that otherwise the dosages were quite small and not excessive for such a patient. Dr. Lindberg merely opposed the prescription of the medication because he believed that the law changed regarding the use of this drug, such that after August 30, 1980, it is only permissible for narcoleptic symptoms. In any event, the Respondent's diagnosis of the patient was uncontradicted and the 92 year old patient was shown to benefit from this treatment of her condition because it permitted her, with the assistance of the visiting nurse, to continue living independently rather than suffering commission to a nursing home or other institutional facility. Count VII concerns alleged prescriptions of amphetamines to one Doris Calloway between February 16, 1982 and October 13, 1982. Petitioner failed to introduce any evidence or testimony concerning this count. With regard to Count XI, Respondent prescribed on only one occasion, 50 Biphetamine capsules for Lori Carroccia on September 29, 1980. At the time this prescription was written and issued, the Respondent was unaware of the recent restrictions imposed by the legislature on the purposes for which amphetamine-type drugs could be prescribed by the passage of Section 458.331(1)(cc), Florida Statutes, effective July 1, 1980. The Respondent had known this patient for approximately six years and she was his nurse, employed at his clinic at the time the prescription was written. The single prescription was written when she complained to him of difficulty in starting a weight loss program and asked for his assistance. Prior to writing the prescription, he checked Ms. Carroccia's physical health, checked her weight and blood pressure, and indeed was already aware of her medical history because of his close association with her. During the entire two months she received this medication Respondent saw her on a daily basis and monitored her progress. The medication proved to be an effective means for her to develop a successful weight loss program. She suffered no adverse effects from receiving this drug. The Respondent only prescribed this medication once, in a small dosage to Initiate her weight loss program and not for the purposes of maintaining weight loss or a particular weight level through long-term prescriptions. Petitioner's sole expert witness conceded that the dosages were not excessive and were medically indicated in the PDR for the initiation of such a weight loss program. Petitioner's expert witness admitted that his opinion regarding inappropriateness of the prescription was solely predicated on the change in the legal status of the drug. The Respondent prescribed an amphetamine medication to patient Evelyn Lilly between April 14, 1981 and December 19, 1981 (Count XII). Ms. Lilly had been his patient since 1979 for allergy evaluation and treatment to alleviate chronic symptoms of runny nose, throat infections and irritations and sinus headaches. Respondent gave her an allergic evaluation in response to these symptoms. In completing her patient history he noted that Ms. Lilly suffers from rheumatism and arthritis. During the course of her allergy treatments Ms. Lilly's weight began increasing dramatically, with a worsening of her arthritic condition. Respondent noted she was markedly fatigued and became concerned about her general physical condition. In response to her fatigue or lassitude complaints, he initially performed a thyroid test in an effort to determine the cause of her lassitude and rapid weight gain. That test was inconclusive. lie then decided that between the complications of arthritis and her allergies he must reduce her weight before he could successfully treat either of those conditions. He initially prescribed Tenuate Dosepan which proved ineffective and then Ritalin, which also proved ineffective. She was then prescribed a course of Biphetamine. She responded dramatically to this medication with relief of her lassitude and the loss of 30 to 40 pounds. After noting that the initial sympathomimetic type drugs prescribed were ineffective and that the change to the Biphetamine produced markedly successful results, Respondent came to the conclusion that the patient was narcoleptic. Narcolepsy sometimes is not alleviated with the prescribing of one type of sympathomimetic drug when the switch to treatment with another type will suddenly prove to be successful in alleviating the narcoleptic symptoms. The doctor's chart for this patient did not definitely indicate the purpose of the prescription of the amphetamine medication, although Dr. Klotz candidly responded in his testimony that it may have been in part for weight control because a reduction in weight would help alleviate her arthritic joint problems. However, inasmuch as narcolepsy can be indicated when one type of sympathomimetic drug will not relieve its symptoms and another type will and since is. Lilly in her reaction to the medications displayed this phenomenon, Respondent, in the reasonable exercise of his medical judgment concluded that she displayed symptoms of narcolepsy. This view is corroborated by Dr. Von Hilsheimer. He has had more than 1,000 patients referred to him over the years by the Respondent. Approximately one-third of these patients were obese and yet he was only aware of four such patients who were treated with biphetamines by the Respondent. Be thus concludes that the Respondent used some differential reason other than mere weight control for prescribing biphetamine which led to the diagnosis of symptomatic narcolepsy with Ms. Lilly. The Petitioner's expert witness once again felt that the Biphetamine and Ritalin prescriptions for Ms. Lilly were inappropriate and excessive, but acknowledged that his criticism of these prescriptions was predicated solely on the fact that the medication had become illegal for prescription for weight control purposes before Ms. Lilly's prescriptions were made. Dr. Lindberg ultimately agreed however, after consulting the PDR that the amounts and types of medication were within appropriate indications, dosage limits and amounts and thus the amounts prescribed were within the reasonable exercise of the Respondent's judgment as a physician for the symptoms displayed, and alleviated them. Concerning this patient, as with all the others involved herein, Petitioner's expert witness bases his testimony merely on the doctor's patient chart which does not specifically refer to narcoleptic symptoms. Respondent admits his records are not detailed in all cases, since the patients were not referrals, but were his patients for many years such that he was intimately familiar with their histories and conditions. Based on the lack of reference to narcoleptic symptoms in the records themselves, Dr. Lindberg opined that the prescription was medically inappropriate, however, the mere absence of reference to that condition in the medical records alone does not establish the medical inappropriateness of the prescription, especially in view of the Respondent's showing (corroborated by Dr. Von Hilsheimer) that indeed Ms. Lilly was narcoleptic. Mr. Emmett Peter was prescribed biphetamines between October 16, 1979 and September 14, 1982 by the Respondent (Count XVI). Mr. peter has been Respondent's patient since 1969 and `gas definitely diagnosed as a narcoleptic individual by a physician who treated him prior to that time and related that fact in his initial medical history provided Respondent. At the time he and his wife became patients of the Respondent, Mr. Peter was receiving a medication called Obedrin, which is a dexedrine-type drug. During the entire time he received medication from the Respondent, he periodically visited the Respondent on his own behalf, as well as accompanying his wife to the Respondent's clinic for treatment, at which times the Respondent also observed Mr. Peter. Although the Respondent was unaware of the change in the law regarding restriction of the use of amphetamines to the treatment of narcolepsy at the time he prescribed Mr. Peter's medications at issue in this case, he continued to prescribe the medication for Mr. Peter after he became aware of the law, because he definitely diagnosed Mr. Peter to be a narcoleptic. The Respondent's expert witness, Dr. Von Hilsheimer, has seen both Mr. and Mrs. Peter on a professional basis as a researcher. He had numerous occasions to observe Mr. Peter, approximately twice a week from March, 1980 through May, 1982. Be became quickly aware of the fact that Mr. Peter was narcoleptic due to the fact that Mr. Peter, when waiting for his wife at Dr. Von Hilsheimer's office, often fell asleep in a very dramatic way, sometimes even when Dr. Von Hilsheimer was engaged in conversation with him. It was thus established that Mr. Peter, based upon his medical history and the personal observation of both Dr. Klotz and Dr. Von Hilsheimer, suffers from a minimal brain dysfunction manifested as excessive, inappropriate sleepiness. Dr. Von Hilsheimer further noted that Mr. Peter's condition is also characterized by moderate cataplexy, another symptom of narcolepsy. There is no question that Mr. Peter suffers from narcolepsy, therefore the prescription of amphetamine medications to Mr. Peter was clearly medically appropriate and the Petitioner admitted that the amounts of the medication were not excessive. On February 24, 1981, Charne D. Porter, the Respondent's daughter was given a prescription for 30 10-mg Ritalin tablets (Count XVII). The Respondent has been her treating physician most of her life. At the time the prescription was written she was editing and producing a motion picture. She was working very long hours and complained to Respondent that she was having difficulty staying awake during all times of the day and in completing her film-editing work. Prior to this period of time however, her typical work schedule involved such long hours with no apparent ill effects. This was not an unusual work schedule for her. Dr. Von Hilsheimer has known Ms. Porter since 1979 and she has consulted him professionally in the past. He was quite familiar with the patient history and had occasion to see her during the time the medication involved was prescribed. During this period of time he found that when she was attempting to do film-editing work which is normally a stimulating, arousing type of endeavor, she did not have her normal responsiveness and while talking to him would doze off in the middle of a conversation in his office. The work she was trying to do at the time was quite arousing under unusual conditions of lighting and interest and yet she would still doze off at inappropriate times during the day while working. The doctor did not find that her long work schedule or hours were responsible for such a condition. Ms. Porter had a debilitating illness consisting of the lingering aftereffects of a form of hepatitis and this, coupled with the stress related to her film-editing job (for which she was obtaining treatment through self-hypnosis training by Dr. Von Hilsheimer) caused her to lose her normal "arousal ability." Because of this she did have an attack or episode of transient narcolepsy as diagnosed by Respondent and Dr. Von Hilsheimer. During visits in his office he observed her display three of the four commonly recognized symptoms of narcolepsy during approximately the same period of time in which she received the Ritalin prescription. These inappropriate sleep episodes were a transient condition and Ms. Porter recovered from that condition and is functioning well personally and professionally. The small original Ritalin prescription needed no renewal. The use of the Ritalin prescription was a reasonable exercise of Respondent's medical judgment and approach to alleviating the transitory narcolepsy symptoms exhibited by Ms. Porter and caused her no harm whatever. Patient Sandy Lee Bradford was prescribed Biphetamine between December 14, 1980 and December 15, 1981. She is the daughter of the Respondent's secretary and has been the Respondent's patient for many years. On December 15, 1980, due to her complaint of fatigue, daytime sleepiness episodes, along with inability to lose weight and excessive weight gain, the Respondent first prescribed biphetamines to her. Over a one year period she subsequently received four other prescriptions of biphetamines. Each time she received a new prescription, she personally saw and consulted with Dr. Klotz. At the time the prescriptions were administered she had recently been divorced and was suffering unusual stress and emotional anxiety related to that divorce, which Respondent believed had a direct effect on her sudden weight gain and inability to lose weight. At the time the Respondent made these prescriptions, he was as yet unaware of the change in the legal status of amphetamine-type drugs such that it was no longer legally permissible to prescribe them for weight loss purposes. The Respondent candidly admitted that he primarily prescribed the drugs for assisting her in embarking on a successful weight loss program, not for chronic use. Other anorectic medications had been tried on this patient and had proved ineffective, however, with the judicious prescription and use of the biphetamine medication the patient made substantial progress in losing weight and in alleviating symptoms of fatigue. When Respondent became aware of the change in the legal status of biphetamines, he discontinued that medication promptly and substituted Tenuate Dosepan, which proved ineffective. He then substituted Ionamine which also proved ineffective, in an attempt to avoid prescribing biphetamines for the patient. The biphetamines prescribed were in appropriate, non-excessive quantities for the condition and symptoms exhibited by the patient and successfully alleviated her complaints with no harm to the patient. He discontinued biphetamines because he felt he could not with reasonable medical certainty, diagnose her as a narcoleptic patient. Dr. Lindberg conceded that the prescriptions were medically appropriate, but for the change in the law regarding their permissible use, and that change was the sole basis for his opinion that the prescription was inappropriate. Patient Trudy Heintz was prescribed Dexedrine between January 3, 1980 and October 29, 1982. She has been a patient of the Respondent since the early 1950's. She has displayed, over many years, symptoms of excessive, inappropriate daytime sleepiness and a simple inability to perform her employment duties as a result. The Respondent was treating her for phlebitis and arthritis, and thus she is an internal medicine patient. As such the Respondent monitored her physical condition quite closely, making physical examinations including monitoring of blood pressure when necessary. He observed no adverse effects caused by the administration of Dexedrine to this patient, which alleviated her narcoleptic symptoms and enabled her to remain productive and fully functional in her employment and daily pursuits. The Respondent thus diagnosed her as suffering from narcolepsy and established that as an appropriate basis for the prescription of Dexedrine. He continued to prescribe Dexedrine for the patient, even after he became aware of the restriction of its use because he genuinely believes that she is a true narcoleptic. Dr. Lindberg opined that the Dexedrine was inappropriate medication and was prescribed in excessive amounts. He did not believe that Ms. Heintz exhibited narcoleptic behavior, but he had never observed the patient and based his opinion merely upon less than detailed references to narcoleptic behavior in the patient's records. The Respondent, however, established that this patient had been a patient for many years and he was intimately familiar with the physical condition, complaints and medical history, and makes notes only for his own use. Because of his familiarity with her medical history and problems, it was unnecessary for him to make his own notes in sufficient detail so that Dr. Lindberg would be able to thoroughly review the patient's status and treatment indications by looking at her chart alone. Dr. Lindberg, in opining that the dosage was excessive at 30 mg. per day failed to take into account that the PDR provides that the accepted prescription of Dexedrine for narcolepsy is from 5 mg to 60 mg per day with no time limitation as to its use. His opinion as to excessiveness was based on the medical indications in the PDR for obesity only, not for narcolepsy. Such a dosage for this patient was not excessive in view of her proven diagnosis of narcolepsy. Count XXI concerns the purchase on October 14, 1981, of 1,000 quaalude tablets with regard to which it is alleged that the Respondent failed to maintain proper records justifying purchase and disposal of them as allegedly required by Section 21 USC 1306.04(b). Section 21 USC 1306.04(b) has not been placed in evidence in this proceeding, nor has it been made the subject of judicial notice, pursuant to Section 120.61, Florida Statutes. In any event, the 1,000 quaalude tablets were purchased by the Respondent for use by his wife, Harri Klotz. The Drug Enforcement Administration (DEA) Form 222, required to be maintained by the purchaser of such drugs was maintained by the Respondent and his office manager, and a dispensing record also maintained by them shows that the medication was dispensed upon receipt to Respondent's wife. In fact the drugs were established to be retained in the Respondent's office under lock and key and not physically dispensed to the Respondent's wife at one time, rather they were dedicated to her use, but maintained securely on the Respondent's office premises. Mrs. Klotz was then dispensed 30 tablets at a time in approximately one and one-half to two month intervals, and an additional journal card was established by Ms. Lindblom, the office manager, showing the dates when Mrs. Klotz drew down upon that medication in 30 tablet increments which withdrawals were recorded ads "pills dispensed." Additionally, the 130 methaqualone tablets prescribed for Mrs. Klotz on June 24, 1982, were for the purpose of providing her an additional supply to be used in a light, periodic, controlled manner because the drugs were about to become illegal. Later in August or September, 1982, Ms. Lindblom, when she became aware that the additional prescribing of methaqualone might be illegal, upon advice of Mr. Meiner, the Respondent's counsel, elected to dispose of the remaining quaalude tablets at which time 790 of the original 1,130 tablets dedicated to the use of Mrs. Klotz remained at the Respondent's office and were disposed of. Thus the receipt of 1,000 quaalude tablets was duly recorded in Respondent's record and the 30 tablet dispensations of the medication periodically from October 14, 1981 through June 28, 1982, were recorded in a dispensing record in evidence, which record also reflects the disposal of the 790 unused tablets.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses and the pleadings and arguments of counsel, it is, therefore RECOMMENDED: That the Administrative Complaint against the Respondent, Solomon D. Klotz, be DISMISSED except as to the minor violations of Section 458.331(1)(h) and (cc) Florida Statutes, proven with regards to Counts XI and XVIII for which, under the circumstances of this case, no disciplinary action should be taken. DONE and ENTERED this 4th day of May, 1984, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of May, 1984. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Chief Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Sam C. Meiner, Esquire 26 Wall Street Orlando, Florida 32801 Helen C. Ellis, Esquire 1804 Old Fort Drive Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact The Respondent, Clayton E. Linkous, Jr., M.D., at all times pertinent to this proceeding, has held a current and valid medical license issued by the Board of Medical Examiners of the Department of Professional Regulation. The Petitioner is an agency of the State of Florida charged with enforcing the requirements of Chapter 458, Florida Statutes, and appurtenant rules involving the licensing of physicians, the regulation of their licensure status and the enforcement of standards of professional practice of physicians it licenses to practice in the State of Florida. The Respondent received his medical degree from the University of West Virginia Medical School. Be entered the Navy and served a "rotating internship" at Bethesda Naval Hospital. He was on the staff at Bethesda Naval Hospital for approximately one year. The Respondent then came to Pensacola for Naval Flight Surgeon training and was ultimately assigned to Camp Pendleton, California. The Respondent later was assigned to Vietnam with the Marine Corps as a Flight Surgeon and General Surgeon. Upon concluding his tour of duty in Vietnam, the Respondent returned to the Naval Air Station in Pensacola where he was placed in charge of the Division of Physical Evaluation of Aviation Medicine, serving in that post for some two and a half years. The Respondent resigned from the service and opened a practice of emergency medicine at Sacred Heart Hospital in Pensacola, serving in that capacity for approximately four years. The Respondent then entered private practice in the areas of acute medicine and family practice, which practice he was engaged in at the time of the hearing. The Respondent is a member of the County Medical Society in Escambia County, the American Medical Association, Southern Medical Association, Association of Military Surgeons and a Charter Member of the American College of Emergency Physicians. The Respondent is current on continuing medical education requirements through September, 1983. In January of 1978, Mrs. Julie Hebert visited the Respondent with complaints of a recent weight gain of 7 pounds and sleeping long hours. Mrs. Hebert weighed approximately 101 pounds at that time. The Respondent treated Mrs. Hebert for sleeping long hours and for depression, for which he prescribed antidepressants as well as anorexiants, which are appetite suppressors. During his course of treatment of Mrs. Hebert on this and later occasions, the Respondent failed to record her height, which has a direct relationship to a determination of her ideal weight, although he was treating her to alleviate a supposed excessive weight gain. The Respondent also failed to take a psychosocial or neurological examination of Mrs. Hebert and thus, of course, failed to make a written record of any such examination or history. The Respondent made a diagnosis of obesity. The patient complained of a 7 pound weight gain and her weight was 101 pounds, but if a diagnosis of obesity is made, the usual and reasonable course of treatment for a physician engaged in family practice is to try and predict an ideal body weight or weight loss goal, interview the patient extensively with regard to diet habits, exercise habits and then try to make recommendations to modify those in order to alleviate the diagnosed condition of obesity. This should always be done before an anorexiant drug is prescribed and the appropriate standard of care for a patient with a diagnosis of obesity does not consist of merely prescribing anorexiants to suppress appetite. Anorexiants suppress the appetite control center of the brain. Their use can be helpful to suppress appetite during the first few weeks of treatment for obesity, but they must be prescribed as a part of a total program of weight control consisting of diet modification and exercise on a long-term basis. Anorexiants provide a diminishing return in their benefits in treating obesity because, as their use continues, their effectiveness diminishes and an increasing dose is required as a few weeks elapse. The need to increase the dosage to achieve the same effect of suppressing appetite, and therefore weight control increases geometrically. Thus, if their dosages continued at or near the originally prescribed amount, the anorexiant soon no longer has the effect of suppressing the patient's appetite and the patient has nothing helping him to lose weight unless an appropriate diet and exercise program was thoroughly discussed and prescribed. On the other hand, if anorexiant dosages are increased as their beneficial effect diminishes, then the serious side effects of anorexiant drugs come into play. Anorexiants cause an elevated pulse rate and an increased body temperature similar to that of an adrenaline response or "high active state." Anorexiants are amphetamines or "amphetamine-analogue" drugs, which, because of their stimulative effects, often cause cardiac arrhythmias and increasing dosages can often prove seriously harmful or fatal to a patient. Because of these potentially dangerous effects of anorexiant medications and because their use necessitates geometrically increasing dosages in order to remain effective in weight control, the use of such "amphetamine- family" anorexiants is inappropriate in a patient like Julie Hebert, particularly because of her age of 17 years, because of the potential for causing serious heart rhythm abnormalities and possible death, as well as the addictive potential of such increasing dosages. The use of anorexiants were especially contraindicated in the case of patient Hebert because no long-term diet and exercise modification program was discussed with the patient nor prescribed and the diagnosis of obesity, when the patient reported a recent weight gain of only 7 pounds and only weighed approximately 101 pounds on the first examination, was established to be incorrect. (Cohen deposition; Petitioner's Exhibit 2) The Respondent also diagnosed Julie Hebert, as suffering from depression. The appropriate standard of care in treating depression is a thorough consultation with the patient about depression, its causes and means for alleviating it. A family practitioner practicing an appropriate standard of care in dealing with depression should recommend counseling for the patient herself, as well as involving her family and should take an extensive psychosocial history of the patient's personal and family background in order to assist him in determining the causes of her depression. The Respondent failed to do this in this case. Instead he immediately prescribed two antidepressant medications, which, without the accompanying consultation and counseling and eliciting of a detailed history, can be a potentially dangerous deviation from the standard practice when dealing with such a 17-year-old patient. Antidepressant medication, when appropriately prescribed, requires approximately four weeks to exert its full, antidepressant effect. Its benefit is not immediate, but rather is a cumulative effect. This patient's antidepressant medications, however, were changed frequently. Two medicines were prescribed the first visit and two different antidepressant medications were prescribed on the next visit and still a third medication prescribed on the her third visit, all in the space of less than two months. In fact, on her third visit a major phenothiazine tranquilizer was prescribed when, according to the Respondent's notes, the patient seemed anxious and agitated. That type of medication is used to treat schizophrenia or a major psychosis. There is no psychosocial history in the case of Julie Hebert to indicate that she had or ever had a psychosis which would justify prescribing that drug, especially in view of the fact that it represented a third change from the previous course of antidepressant medications prescribed. The changing of antidepressant medications three times in less than two months is not a course of treatment followed by reasonable, prudent general practitioners or family practitioners in treating such a patient because an insufficient opportunity was provided for the initial medications prescribed to render their full beneficial effects before their use ceased. Further, the doctor prescribed three different amphetamine-family medications in less than three weeks and failed to keep any record of the amounts of any of those medications. The use of such amphetamine-family drugs or anorexiants has no therapeutic place in diet therapy, especially with a 17-year-old girl who only weighs approximately 101 to 105 pounds. On April 18, 1978, patient Gloria Brock visited Respondent at his office complaining of a weight problem. At that visit the Respondent failed to record the patient's height and failed to record an ideal body weight or any weight loss goals. No record was made of the patient's diet habits or exercise habits, nor the type of therapy he prescribed for her. The doctor did prescribe a substantial number of medications. He prescribed diuretics, thyroid medication and amphetamine-family anorexiants. The doctor prescribed Tofranil, an antidepressant; Valium, a minor tranquilizer; Oretic, a diuretic; Thyrolar, a thyroid hormone; Ionamin and Bacarate, both amphetamine analogue medications; and well as Midrin, a headache medication. The sole diagnosis underlying these prescriptions was the patient's weight problem. The doctor next saw this patient on May 9, 1978, at which time he refilled the prescriptions for the previous medications and added a prescription for Phenaphen #2, a narcotic analgesic and Didrex, a different diuretic medication. On that visit she had an additional complaint of mild muscle tenderness in her neck. On June 15, 1978, she came in complaining of additional problems involving miofasciculitis and vascular cephalgia (sore muscles and headaches). He refilled the previous medications, except the Oretic and Tofranil, and added a prescription for Elavil, which is a different anti-depressant from that previously prescribed. He also increased the dose of thyroid hormone. On July 17, 1978, she again visited the Respondent's office and he administered an injectable medication called Vernate, a decongestant and antihistamine combination. Vernate has no therapeutic purpose with a patient in Mrs. Brock's medical situation. The patient also received an injection of Keflex, as well as Comhistla and Ionamin injections. Keflex is an antibiotic. The Respondent had made a note on that date that he thought her ear canal was inflamed or infected. The Keflex was used, however, in conjunction with Terramycin, which is a brand of Tetracycline, the use of which in combination with Keflex is wholly inappropriate. The use of the antibiotic Keflex with the antibiotic Tetracycline is incompatible and the Tetracycline actually will impair the effect of the Keflex prescription. Comhistla is an antihistamine decongestant and Ionamin is a amphetamine-family anorexiant. On September 6, 1978, the Respondent prescribed to her Parafon Forte, a muscle relaxant; Triaprin DC, which is an analgesic containing synthetic Codeine; Histalet, an antihistamine and Minocin, an antibiotic. No record was made by the Respondent of any of these prescriptions. The next office visit was October 23, 1978. No complaints by the patient were recorded for that date, but some physical findings were noted such as her weight (121 3/4 pounds) and that her nasal mucus membranes were swollen. The patient received three injectable medications that date; Iatric, a multi- vitamin combination that is combined with Testosterone and Estrone. That medication is designed for geriatric use and has no therapeutic value in treating Mrs. Brock, a 38-year-old patient with no symptoms indicating its use. She was also injected with vitamin B-12. The only therapeutic indication for a B-12 injection is for pernicious anemia, which Mrs. Brock did not have. Vernate was again injected on that date. The Respondent also prescribed Brexin, another amphetamine-family anorexiant; another antibiotic (Erythromycin); Sinequan, an anti-depressant; and refilled Thyrolar, a thyroid medication. On November 15, 1978, Mrs. Brock came to his office complaining of a muscle spasm. At that time she was injected with Aristocort and Vernate. Prescriptions were also given on that date for Soma Compound, an analgesic- muscle relaxant combination. The next visit was January 18, 1979, when the previous medications were re-prescribed. The Respondent made no notes on that visit regarding the patient's complaints and no physical findings were recorded in his notes. The Respondent last saw this patient on January 30, 1979, and injected her with Lincocin, an antibiotic; Aristocort, a cortisone synthetic preparation; and Cofene, another decongestant-antihistamine combination. On that visit she complained of intermittent auxiliary or underarm swollen glands as well as swollen glands in the groin area (lymphnodes), nausea and weakness. Prescriptions for Vectrin, Elavil and Cofene were given on that date. Those are, respectively, antidepressants and an antihistamine decongestant. . . None of these medications were medically indicated for these complaints. The Respondent's records and notes made during this visit and his course of treatment of Mrs. Brock do not reflect an appropriate history, physical findings or amounts of drugs prescribed. Some of the later physical complaints by the patient during her course of treatment, such as nausea and weakness, are actually signs of misuse or overuse of the medications prescribed and yet the Respondent's later prescription practice and treatment of the patient does not reflect consideration of any adverse drug reactions or side effects. Patient, Vassie Johnson, came to the Respondent on November 7, 1977, complaining of a weight problem. The Respondent recorded her weight as 190 pounds and her age as 60 years and made no recordation of her height at that time as it related to her then present weight or her ideal weight. The Respondent prescribed Ionamin and Bacarate, two amphetamine anorexiants. He also prescribed Hygroton, a diuretic; Thyrolar, which is a thyroid hormone; Quibron Plus, a bronchial dilator; Triavil, an antidepressant. The Respondent diagnosed her problems as being chronic, obstructive pulmonary disease; peripheral vascular insufficiency; obesity; and Mitral Valve Prolapse, a disease or condition of the heart. When she came to the Respondent on this first visit, this patient was already taking the following medications: Triavil, an antidepressant; Donnatal, a gastro-intestinal anti-spasmodic; Dyazide, a diuretic; Inderal, an anti-hypertensive drug; Premarin, a female hormone replacement; Nicotinic Acid; and Librax, a gastro-intestinal anti-spasmodic. The patient had indicated on the personal history she supplied the Respondent that she had emphysema, that she had high blood pressure (hypertension), and that she had Mitral Valve disease of the heart. The prescription of amphetamine-family anorexiants are particularly dangerous for someone known to have heart disease and are contraindicated with a patient who has hypertension, as this patient did. This is because the stimulant effects of such drugs speed the heart rate, stress the heart muscle and elevate the blood pressure in someone who already has a problem with elevated blood pressure. Such a course of treatment with a patient such as Mrs. Johnson could have serious adverse health consequences for her, possibly even fatal ones. The standard treatment for obesity with a patient such as Mrs. Johnson is to do a standard medical history, including her diet and exercise history. The practitioner should then establish a program of diet and exercise habit modification appropriate to the patient. The doctor's records do not reflect that this was done with Mrs. Johnson. Catecholamine is a substance produced by cells in the nervous system which acts as a stimulant. Exogenous catecholamines are drugs that have that same effect. They are prescribed for persons with asthma or lung disease, but should not be used with amphetamine-family anorexiants. The Respondent however prescribed two amphetamine-family anorexiants on the same occasion that he prescribed Quibron Plus, a bronchodilator (catecholamines) which is clearly contraindicated in the manufacturer's recommendations. As noted above, amphetamine-family anorexiants can cause heart rhythm problems. On the very next visit, November 28, 1977, Mrs. Johnson complained of chest pain and Dr. Linkous' notation for that visit notes that it is relieved by nitroglycerin. He also notes, in addition to chest pain, that the patient had an occasional extra heart beat or altered heart rhythm. This is a known adverse side effect from the prescription of amphetamine anorexiants. Thus the Respondent, already having a history of the patient's heart problems before prescribing the anorexiants the first time, was supplied additional unequivocal evidence of the patient's heart condition by her complaints of chest pains and altered heart rhythm. In spite of this, on the next visit, on December 5, 1977, the doctor merely prescribed additional medications. Those medications were Hygrotin, a diuretic, P 200 (nature unidentified) ; Bacarate and Ionamin, the same amphetamine-family anorexiants once again. The heart symptoms she experienced at that time are consistent with the known side effects of the prescription of such amphetamine-family medications. Two days after the patient had complained of chest pains and occasional irregular heart beat, November 30, 1977, the Respondent admitted her to Sacred Heart Hospital of Pensacola. His diagnosis at that time consisted of ruling out ischemic myocardial disease, peptic ulcer disease, chronic obstructive pulmonary disease, hyperthyroidism. In his admission summary, the doctor made no record whatever of the medication already prescribed to the patient and which she was at that time taking. He merely indicated in his admission summary the medications the patient was already taking when she first came to him for her first visit. The subsequent office notes during the Respondent's entire course of treatment of this patient do not reflect the course of treatment in the hospital nor that she was ever hospitalized, which is a significant error of omission, as is the failure to record in the hospital admissions summary the medications the patient had been taking and was taking. On December 23, 1977, Mrs. Johnson returned to the Respondent complaining of dysphagia, meaning difficulty in swallowing. The doctor's records don't reflect that any prescriptions were given on that date. She again returned to the Respondent on February 13, 1978, and the doctor's notes indicate that the same medications were continued. In summary, there is no question that the care he provided these three patients was indeed quite dangerous and could or may have been substantially harmful to them. The Respondent has never been charged with a violation of statutory professional practice standards and has never been disciplined with regard to his licensure status.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence in the record and the candor and demeanor of the witnesses, it is, therefore RECOMMENDED: That the Respondent, Dr. Clayton D. Linkous, Jr., be found guilty of violating Subsections 458.1201(1)(m) and (k), Florida Statutes (1977), as substantially reenacted by Subsections 458.331(1)(t) and (h), Florida Statutes, and that his license be suspended for one (1) year, but with that suspension to be stayed and held in abeyance after 45 days of that suspension has been served, and that it be permanently abated after the Respondent demonstrates to the Board that he has successfully completed a continuing medical education course designed to enhance his skills regarding the appropriate use of drugs in medical practice and therapy, appropriate prescription practices and appropriate patient record-keeping and monitoring. DONE and ENTERED this 4th day of June, 1983, in Tallahassee, Florida. P. MICHAEL RUFF, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of June, 1983. COPIES FURNISHED: Harold E. Regan, Esquire The Whitehouse - Suite 3 203 North Gadsden Street Tallahassee, Florida 32301 Paul W. Lambert, Esquire 1114 East Park Avenue Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Nonroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION, Petitioner, vs. CASE NO. 81-1631 CLAYTON E. LINKOUS, JR., M.D., License No. 15233 Respondent. /
The Issue The issues are whether Respondent obtained Oxycontin by using a forged prescription, in violation of Section 464.018(1)(h), Florida Statutes, and Rule 64B9-8.005, Florida Administrative Code, which prohibit unprofessional conduct, and in violation of Section 464.018(1)(i), Florida Statutes, which prohibit the unauthorized possession, sale, or distribution of controlled substances; and whether Respondent's use of Oxycontin affects her ability to practice nursing with reasonable skill and safety, in violation of Section 464.018(1)(j), Florida Statutes, which prohibits the inability to practice nursing with reasonable skill and safety by reason of illness or use of alcohol, drugs, narcotics, or chemicals or as a result of any mental or physical condition. If so, an additional issue is what penalty should be imposed.
Findings Of Fact Respondent is a licensed registered nurse, holding license number RN 521142. She has been so licensed for 31 years. Respondent's long career in nursing has featured dedication, hard work, commitment, and competence. The record does not reveal any past discipline. For most of Respondent's professional career, starting in 1971, she has worked at Indian River Memorial Hospital in Vero Beach. Respondent has worked in various capacities at the hospital, including the emergency room and operating room. Respondent later helped develop a neurological unit at the hospital. Starting in 1980, she worked for a couple of years at Vero Orthopedics. Since 1997, Respondent has worked on a contract basis at the Indian River Memorial Hospital, although her present physical infirmities, partly described below, prevent her from working at present. In May 2000, Respondent injured her back while moving a heavy patient in the hospital. A couple of months later, Respondent underwent a laminectomy to relieve the pain from two herniated disks. Six weeks after the surgery, Respondent reinjured her back and had to undergo additional surgery. Six weeks after the second surgery, Respondent, who was not doing well, left her job at the orthopedic clinic and took a less strenuous job. One month after doing so, Respondent was still experiencing pain when she got into and out of cars. In June 2001, Respondent underwent a third operation, in which the surgeon fused two injured vertebrae. The surgery obtained access to the vertebrae by a posterior incision running from the breast to the pubis. The surgery also required a hip bone graft, thus necessitating an incision to the hip. The recovery from this excruciatingly painful surgery was difficult, and Respondent has not yet returned to work, although she is nearing the point at which she can perform some nursing-related work, such as teaching. At present, she still has difficulty walking or standing. When discharging Respondent from the hospital in late June 2001, Dr. Gomez prescribed her Oxycontin for pain. Dr. Gomez was covering for Respondent's neurosurgeon, Dr. Magana. Later, Dr. Cunningham, a pain management specialist and Respondent's family physician, resumed the care of Respondent. Dr. Cunningham continues to monitor Respondent and treat her pain. On direct examination, Respondent testified that she has not taken Oxycontin since December 2001. (However, on August 9, 2002, Respondent told her certified addictions professional that she had not taken any Oxycontin since March 2001.) Respondent testified that, after Oxycontin, she took no pain medication besides nonsteroidal anti-inflammatory medications and steroids. However, on cross-examination, Respondent admitted that she takes Methadose as needed, pursuant to a prescription from Dr. Cunningham. Respondent testified that he switched her from Oxycontin in July 2002. Respondent filled the Methadose prescription at a different drug store than the one that she has used for her other prescriptions. On October 5, 2001, Respondent presented a forged prescription to a different drug store than the one she has used for her other prescriptions. The prescription was for fifty 20- mg. Oxycontin tablets, which Respondent picked up two days later. Respondent fraudulently obtained the Oxycontin for her own use. Oxycontin is an analgesic opioid and a schedule II controlled substance. It is highly addictive and presently among the most commonly abused controlled substances. Oxycontin can produce a feeling of short-lived euphoria, as well as impaired cognitive functioning and impaired judgment. Methadose, a form of methadone, is a synthetic analgesic. It is also used in the detoxification process undergone by heroin addicts. Petitioner has proved by clear and convincing evidence that Respondent engaged in unprofessional conduct in her acquisition of the Oxycontin by using a forged prescription and that Respondent unlawfully possessed a controlled substance. Petitioner has not proved by clear and convincing evidence that Respondent's use of Oxycontin affects her ability to practice nursing with reasonable skill and safety. First, Petitioner did not prove by clear and convincing evidence that Respondent still uses Oxycontin. It appears likely that she may have substituted Methadose for Oxycontin to manage her pain. It is unclear from the present record whether Respondent's use of Methadose is also to assist her in overcoming an addiction to Oxycontin. But even if Petitioner had pleaded Methadose rather than Oxycontin, the record does not reveal the extent to which Respondent presently uses Methadose. For the reasons stated in the preceding paragraph, the relevance of the Methadose is not to prove the third count of the Administrative Complaint, but to underscore the risk that Respondent may pose if she practices nursing at present. Respondent was not candid at the hearing. She was not candid about the October 2001 incident. She was not candid about the recent use of Methadose and was evasive about the drug's properties. The two-hour evaluation that Respondent underwent by a certified addictions professional was cursory and curiously deferential to Respondent. This remarkable evaluation is entitled to absolutely no weight whatsoever. The opinion of the certified addictions professional that Respondent does not suffer from a drug abuse or dependency may or may not be true, but, if true, the result is a chance occurrence, rather than a professional conclusion following the comprehensive collection of relevant, reliable data and the careful, informed analysis of such data. The safeguards provided by the pretrial intervention program, into which Respondent entered after her arrest for the fraudulent acquisition of the Oxycontin, are inadequate. The random drug tests always occur on Tuesdays, just not every Tuesday. The assurances that ensue from Respondent's apparent compliance with the conditions of her probation, which include negative urinalyses, are meaningful, but not sufficiently rigorous to provide the necessary protection to a nurse's patients. On December 26, 2001, Petitioner entered an emergency suspension order in this case. The record amply demonstrates that Respondent will suffer considerable financial distress if denied the opportunity to practice her profession. However, Respondent's lack of candor precludes a detailed analysis of the safeguards in her current monitoring program and a detailed prescription of what, if any, additional safeguards would be required to permit any discipline short of a suspension. In its proposed recommended order, Petitioner seeks a suspension until lifted pursuant to, and subject to the conditions set by, an evaluation coordinated by the Intervention Project for Nurses (IPN); treatment as recommended by the IPN; probation for three years if no treatment is recommended by the IPN; an administrative fine of $750; a reprimand; and the assessment of costs of the investigation and prosecution.
Recommendation It is RECOMMENDED that the Board of Nursing enter a final order finding Respondent guilty of violating Section 464.018(1)(i), Florida Statutes, and imposing a penalty of a $250 administrative fine, a suspension until lifted pursuant to, and subject to the conditions set by, an evaluation coordinated by the IPN; treatment as recommended by the Intervention Project for Nurses; probation for three years if no treatment is recommended by the Intervention Project for Nurses; and the assessment of costs of the investigation and prosecution, upon remand, if necessary. DONE AND ENTERED this 20th day of December, 2002, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 2002. COPIES FURNISHED: Dan Coble, RN PhD CNAA C, BC Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C02 Tallahassee, Florida 32399-3252 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Amy M. Pietrodangelo Assistant General Counsel Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Suzanne H. Suarez Suzanne Hope Suarez, P.A. The Legal Building 447 3rd Avenue North, Suite 404 St. Petersburg, Florida 33701-3255
The Issue Whether CFSATC, Inc. (Petitioner), should be selected as the service provider instead of Metro Treatment of Florida, L.P. (Metro/Intervenor), to meet the need of an additional outpatient methadone maintenance program in the Department of Children and Family Services (DCF), District 7 (Osceola County).
Findings Of Fact The Department of Children and Family Services (DCF/Respondent) notified Petitioner by letter dated May 28, 1999, that DCF had selected another applicant to be the service provider to meet the determined need of one additional outpatient methadone maintenance program in DCF, District 7. As an applicant to be a service provider, Petitioner's interests are substantially affected by Respondent's action. Respondent also notified Intervenor by letter dated May 28, 1999, that Metro had been selected by DCF to be the service provider to meet the determined need of one additional outpatient methadone maintenance program in District 7, as published by Respondent in the Florida Administrative Weekly. On June 18, 1999, Petitioner timely filed a Petition challenging Respondent's action on May 28, 1999, in "denying its license" with Respondent. On July 7, 1999, Petitioner filed an Amended Petition with DCF which not only challenged Respondent's action in "denying" Petitioner's license, but also challenged Respondent's May 28, 1999, action in "awarding a license" to Metro. On or about August 10, 1999, Metro filed a Motion to Intervene in the instant proceeding which was granted. Intervenor's interests in being selected as the service provider to meet the determined need of an additional outpatient methadone maintenance program in DCF, District 7, as published by Respondent are substantially affected by the Petition seeking to challenge Respondent's action, or request that DCF issue a second license. Determination of Need The intent of Chapter 397, Florida Statutes, as it relates to methadone licenses is to control the growth of methadone programs. Under the statute and rules, DCF is required to complete an annual heroin and methadone treatment needs assessment survey no later than October 1, and publish the results of the survey no later than the following January 1. Respondent failed to complete a needs assessment survey in 1998. In 1999, Respondent, as the State Methadone Authority, conducted a needs assessment for methadone providers by collecting information on four different criteria delineated in Rule 65D-16.014(1)(c)1.c., Florida Administrative Code, including arrest data from the Florida Department of Law Enforcement and information on travel hardship from the local district offices of DCF. The data was compiled into a report which concluded that "a need has been established in Districts 7 and 11," but not in any other district. It is Respondent's responsibility, as the State Methadone Authority, to review the needs assessment data and/or report and to interpret the data, and make a determination as to the number of new medication treatment service providers needed in each district. Respondent determined that there is a need for one additional methadone medication treatment service provider in Osceola County. Respondent's determination of need for only one additional outpatient methadone treatment provider in Osceola County is consistent with past DCF practices of limiting the expansion of medication treatment programs to a single facility at a time. On April 9, 1999, Respondent published a statement of findings in the Florida Administrative Weekly, identifying Respondent's determination of need for the state. The statement which provided as follows: Pursuant to section 397.427, Florida Statutes, and administrative rules adopted thereunder, the Department of Children and Family Services has conducted a survey to determine the need for new medication (methadone) treatment service providers. The survey results are provided by the Department of Children and Family Services District Offices as follows: District 7 and 11 The need for one additional outpatient methadone maintenance program has been established for each of these districts. Prospective applicants for a license to operate an outpatient methadone maintenance program in Districts 7 and 11 may direct requests for an application to the following: District 7-Department of Children and Family Services Alcohol, Drug Abuse, and Mental Health Program Office, 400 West Robinson Street, Hurston Building, South Tower, Suite S-430, Orlando, Florida 32801, Attention: Glen Casel. District 11-Department of Children and Family Services, Adult Care Division, 401 N.W. 2nd Avenue, Room 812, North Tower Miami, Florida 33128, Attention: David Raymond. Districts 1, 2, 3, 4, 5, 6, 8, 9, 10, 12, 13, 14 and 15. The need for additional medication (methadone) services has not been established in these districts. Copies of the assessment report may be obtained from: Department of Children and Family Services, Substance Abuse Program Office, 1317 Winewood Boulevard Building 3, Room 105-I, Tallahassee, Florida 32399-0700. Respondent published a correction to its April 9, 1999, publication on April 30, 1999, in the Florida Administrative Weekly. The April 30, 1999, publication was identical to the April 9, 1999, publication except that it provided for a May 14, 1999, deadline for submitting applications to Districts 7 and 11. No administrative petitions or challenges were filed with Respondent challenging its determination of need for "one additional outpatient methadone maintenance program" for Osceola County. Petitioner filed an application to be a new service provider for District 7 with DCF dated April 14, 1999. The application did not contain a physical address for the proposed clinic. Respondent informed Petitioner verbally and in writing that in order for the application to be considered it would have to provide a physical location or address. In addition, it would have "to provide a fire inspection, evidence of zoning approval, occupational licenses and originally, also a health inspection of the property, which was after the fact." Petitioner secured a physical location and submitted a supplement to its application on May 10, 1999. The fire inspection submitted by Petitioner for the proposed facility showed that it had code violations which would need to be corrected before Respondent could issue a license. Intervenor's original application was sent by Federal Express, standard overnight delivery, on May 13, 1999, addressed to Glen Casel, Florida Department of Children and Family Services, 400 West Robinson Street, Suite 1129, Orlando, Florida. According to the published notice in the Florida Administrative Weekly, prospective applicants for a license to operate an outpatient methadone maintenance program in Districts 7 and 11 are instructed to "direct requests for an application" to District 7, Department of Children and Family Services, Alcohol, Drug Abuse, and Mental Health Program Office, 400 West Robinson Street, Hurston Building, South Tower, Suite S-430, Orlando, Florida 32801, Attention: Glen Casel. The notice does not state a specific address where the application must be filed. Suite 1129 is the District Administrator's Office for DCF, District 7. Respondent sought to verify, prior to reviewing the applications, that Intervenor's application was received by DCF on May 14, 1999. The evidence presented at hearing was sufficient to indicate that Metro's application was received by Respondent on May 14, 1999. In response to DCF's April 9, 1999, and/or April 30, 1999, publication in the Florida Administrative Weekly, Respondent received two timely-filed applications for license to operate one additional methadone outpatient clinic in District 7. One application from Petitioner and one application from Intervenor. The number of responses to Respondent's April 9, 1999, and/or April 30, 1999, published notice of need exceeded the determined need for "one additional outpatient methadone maintenance program" for District 7. When the number of applications exceeds the need determined by DCF, Respondent views the application process as a two-step process. First, Respondent reviews the applications pursuant to Rule 65D-16.014(1)(c)1.c., Florida Administrative Code, to select a service provider based on "organizational capability" to implement DCF's rules; and second, the applicant selected must then come into compliance with all the license requirements of Section 397.403, Florida Statutes, to obtain a permanent license. In looking at the "organizational capability" of the applicants, Respondent rates the applicants based on their ability to implement the required provisions of the administrative rule. It is Respondent's interpretation of both its statute and administrative rules that fire inspections, zoning approval, safety inspection, and occupational licenses need to be in place prior to Respondent's issuing a permanent license to a service provider, but do not necessarily have to be in place prior to evaluating competing applications when the number of applications exceeds the need determined by Respondent. Both applications were evaluated by Respondent pursuant to the rule, for selection of the service provider. In its initial evaluation of two application, Respondent determined that Metro's written policies and procedures demonstrate that its "organizational capability . . . to properly implement the appropriate federal and state methadone regulations" exceeds the organizational capability of Petitioner. Petitioner's Organizational Capability Carol Ball testified that she was the executive director and program sponsor for Petitioner. Ball is not a licensed health professional. She understood that pursuant to Rule 65D-16.014(2)(a), Florida Administrative Code, defining "program sponsor," she could substitute five years' experience in the field of addictions in lieu of being a licensed health professional. Respondent testified that in order to be a program sponsor for a methadone service provider, a person had to be a licensed health professional and have five years experience in the field of addictions. Therefore, Ball did not qualify as "program sponsor." Ball was then recalled as a witness and testified that she was only the program sponsor for purposes of the FDA, not the State of Florida. Ball's testimony that she was not the program sponsor for Petitioner is not credible. Petitioner presented no evidence as to the identity of a program sponsor other than Ball. Petitioner's application failed to include letters of reference or a statement of educational level or work experience for its program sponsor as required by the rules. Dr. Juan Perez Boudet, who is identified in Petitioner's application as the medical director, is a physician licensed by the State of Florida and has worked in the field of addictions for at least 15 years. Petitioner's application did not include résumés or background information for any of its staff. The rules require that an applicant submit written policies and procedures with the application. Petitioner failed to submit any written policies and procedures as part of its original application. Petitioner testified that it did not provide résumés, background information, and written policies and procedures as part of its original application as required by the rules because the information "was not requested by the Department." The person responsible for regulatory and licensing issues for Petitioner testified that she did not review the applicable administrative rules prior to submitting the application. Petitioner submitted an undated policies and procedures manual into evidence at the hearing but presented no testimony about such policies and procedures. Petitioner's policies and procedures manual consists of approximately 200 pages, 50 percent of which are blank FDA and state forms. Petitioner's policies and procedures manual indicates that the manual submitted by Petitioner at the hearing has not been recently updated. Petitioner displayed a lack of knowledge of the requirements of Chapter 65D-16, Florida Administrative Code, and Chapter 397, Florida Statutes, specifically as it relates to the application process. It repeatedly faulted Respondent for any shortcomings in Petitioner's application. Metro's Organizational Capability Dr. Randall B. Greene is identified in both Intervenor's original application filed with DCF on May 14, 1999, and the updated application, tendered into evidence at the hearing, as both the program sponsor and executive medical director for Metro Treatment of Florida, L.P., d/b/a Mid Florida Metro Treatment Center. Dr. Randall B. Greene is a doctor of osteopathy licensed by the State of Florida, License No. OS-0004037. Dr. Greene operated eight methadone clinics in several states, including Florida, from 1985 to 1997, when he sold the clinics to the parent company of Metro. Dr. Greene is currently under a management agreement with Colonial Management Group, L.P., which owns and manages Metro. Under the terms of the management agreement, Dr. Greene's duties include establishing new methadone clinics, formulating policies and procedures that relate to medical practice, and ensure the operation of the methadone clinics from a medical perspective, and complies with federal and state rules and regulations. Dr. Greene exhibited an in-depth knowledge as to the operation of Metro's clinics in each city, as well as staffing patterns. Dr. Greene has been working in the field of addiction in excess of five years as required by the rules. Dr. Greene, as executive medical director of Metro, oversees all medical services provided by Metro's clinics, as well as the licensed physician/medical director for each clinic. Dr. Green's responsibilities are described in Metro's policies and procedures manual as required by the rules. Metro's original application, as well as its updated application, include a résumé for Dr. Greene which sets forth his educational level and work experience, and a letter of recommendation from Dr. Greene's former employer as required. Dr. Greene prepared Metro's application currently at issue. Peter Santostefano is the chief executive officer of Metro and its parent company, Colonial Management Group, L.P. The CEO retains overall administrative responsibility and authority in all center or program matters. William Sheridan is the Vice President of Operations for Colonial Management Group, L.P., a Delaware limited partnership which is authorized to do business in Florida, which owns and manages Metro. It owns and operates eight methadone treatment centers in Florida. He currently supervises five regional directors who supervise 30 methadone programs nationwide. Sheridan holds a Bachelors degree in criminal justice, a masters degree in counseling and is certified as an addictions specialist by the American Academy. Prior to assuming the position of Vice President of Operations for Colonial Management, Sheridan worked directly for Dr. Greene holding positions as a case manager for the Daytona Methadone Clinic in 1987, a program director for the Daytona Methadone Clinic from 1988-1991, with duties including operating a methadone clinic in compliance with state and federal regulations; a regional director from 1991 to 1993 where he had management oversight over all methadone clinic and implemented policies and procedures in a specific geographic area; and vice president of Operations from 1993 until 1997, when Dr. Greene sold his clinics to its current owners. Sheridan was retained as Vice President of Operations by Colonial Management Group, L.P., when it acquired the clinics from Dr. Greene. Intervenor's current organizational structure includes a hierarchy of case managers, program directors, and regional directors. Sheridan is listed on Intervenor's application as the qualified professional, insured training coordinator, and data coordinator and is fully familiar with Chapter 65D-16, Florida Administrative Code, and the duties and functions of each position and stated that he would fill such positions if Intervenor could not hire permanent qualified personnel to fill such positions when the clinic opens. Carol Schwartz will be the program director in Osceola County and is certified as Certified Addictions Professional by the State of Florida. Intervenor identified in its original and updated application that it would open its clinic with three counselors, in addition to its program director. Intervenor identified in its original application and updated application that it would have a licensed professional nurse, Sharon Jones, on staff. She is licensed by the State of Florida. Dr. Greene reviewed the need assessment published by DCF along with a February 19, 1999, letter from the district administrator to Mr. Emenheiser, the "Methadone Authority" and determined that Kissimmee was the best location for the new methadone clinic in Osceola County, as 68 percent of the travel hardship cases lived in Kissimmee. Both Intervenor and Petitioner stated that they anticipated that the clinic in Osceola County would start with about 20-35 patients and would increase over time. Rule 65D-16.014(3)(I)3., Florida Administrative Code, requires that, for methadone programs, there be no more than 45 patients to one full-time counselor. Based on the travel hardship identified by Respondent of approximately 100 patients from the Osceola County area, and a review of Intervenor's organizational chart, Intervenor will be properly staffed to meet the need identified by the Department. Intervenor's application indicated that the program component requested in the application form could grow to 400 patients. Intervenor testified that it adds additional counselors, as needed, to meet the patient-to-counselor ratio required by Respondent. Intervenor's clinic, at all times material to the instant case, has been continuously licensed by Respondent and in good standing. Intervenor has contracted with Dr. Paul "Chip" Roberts to provide medical services in the Osceola clinic on a day-to-day basis. Dr. Roberts' title is that of licensed physician/medical director for purposes of the FDA. Dr. Roberts is a doctor of osteopathy, licensed by the State of Florida, License No. OS-0005120, and has eight years of experience in the field of addiction. Dr. Roberts has worked in the Orlando Methadone Treatment Center, for both Dr. Greene and now Colonial Management Group, L.P., as the clinic's licensed physician/medical director since 1987. Dr. Roberts is responsible for all patients, conducts physical examination, reviews laboratory work, drug screens, and interfaces with nurses and counselors in reference to medical needs. Dr. Roberts can perform the duties in Osceola County, as well as Orlando, as 75 of the patients in Orlando live in Osceola County and will likely transfer. Dr. Roberts, in his capacity as licensed physician/medical director, directly oversees all medical services provided by the program on a day-to-day basis, and his responsibilities are described in Intervenor's policies and procedures manual as required by the rules. Dr. Greene presented testimony regarding the way the policies and procedures operated, the controls in place for inventory, pharmacy, the unique methadone control, staff control, in regard to nurses responsibilities, and how the job is to be performed. Metro's policies and procedures manual consists of 330 pages and over 200 indexed subsections which provide detailed explanations and procedures regarding all aspects of the operation of a methadone clinic, including, but not limited to: administration, program standards, admission procedures, treatment procedures, transfer procedures, detoxification procedures, discharge procedures, pharmacy services and protocols, medical services, and protocols. Intervenor's policies and procedures were developed by Dr. Greene and Sheridan and are updated on an annual basis. Intervenor's written policies and procedures, as submitted at the hearing, demonstrate that its "organizational capability . . . to properly implement the appropriate federal and state methadone regulations" exceeds the organizational capability of Petitioner. Intervenor's original and updated applications contained current general and professional liability insurance policies for Metro, and also covered various physician's whose services are engaged by Colonial Management Group. Intervenor's original and updated applications contained sufficient information that Metro is financially well-able to run the Mid Florida Metro Treatment Center in Osceola County.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Department of Children and Family Services enter a final order selecting Metro Treatment of Florida, L.P., d/b/a Mid Florida Metro Treatment Center, as the service provider to provide methadone outpatient service in accordance with the DCF's determination of need for District 7 and dismissing Petitioner's Petition. DONE AND ENTERED this 15th day of May, 2000, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 15th day of May, 2000. COPIES FURNISHED: Keith A. Graham, Esquire Yovannie Rodriguez-Smith, Esquire Marchena and Graham, P.A. 233 South Semoran Boulevard Orlando, Florida 32807 James Sawyer, Esquire District 7, Legal Counsel Department of Children and Family Services 400 West Robinson Street, Suite S-1106 Orlando, Florida 32801-1782 Wilbur E. Brewton, Esquire Kelly Brewton Plante, Esquire Gray, Harris and Robinson, P.A. 225 South Adams Street, Suite 250 Tallahassee, Florida 32301 Virginia Daire, Agency Clerk Department of Children and Family Services Building 2, Room 204B 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Josie Tomayo, General Counsel Department of Children and Family Services Building 2, Room 204B 1317 Winewood Boulevard Tallahassee, Florida 32399-0700
