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BOARD OF MEDICAL EXAMINERS vs. MANUEL P. VILLAFLOR, 86-003256 (1986)

Division of Administrative Hearings, Florida Number: 86-003256 Latest Update: Feb. 18, 1988

The Issue Whether petitioner should take disciplinary action against respondent for the reasons alleged in the administrative complaint?

USC (1) 21 CFR 1301.72 Florida Laws (2) 458.331, 893.07

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BOARD OF MEDICAL EXAMINERS vs. CARLOS DE LA FE, 83-003502 (1983)

Division of Administrative Hearings, Florida Number: 83-003502 Latest Update: May 08, 1990

The Issue The issues presented herein are whether or not Respondent's incense to practice medicine should be suspended, revoked or the licensee otherwise disciplined for alleged violation of Chapters 458 and 893, Florida Statutes, as set forth in the Administrative Complaint filed herein signed May 31, 1983.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, and the entire evidence of record, it is therefore recommended that a Final Order be entered imposing a written reprimand and one year's probation upon the Respondent Carlos de la Fe, and requiring that during the probationary, he enroll and complete, to the satisfaction of the Board of Medical Examiners, a continuing medical education course concerned with the appropriate indications for and prescription of scheduled controlled substances. 4/ RECOMMENDED this 24th day of October, 1984 in Tallahassee, Florida. JAMES E. BRADWELL 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 25th day of October, 1984.

USC (1) 21 CFR 291.505 Florida Laws (3) 120.57, 458.331, 893.05

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BOARD OF MEDICAL EXAMINERS vs. SOLOMON D. KLOTZ, 83-002370 (1983)

Division of Administrative Hearings, Florida Number: 83-002370 Latest Update: Jul. 03, 1984

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

Florida Laws (4) 120.57, 458.331, 893.03, 893.05

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AGENCY FOR HEALTH CARE ADMINISTRATION vs CREATIVE LIVING CENTERS, INC., D/B/A COVE MANOR RETIREMENT, 02-002511 (2002)

Division of Administrative Hearings, Florida Filed:Panama City, Florida Jun. 20, 2002 Number: 02-002511 Latest Update: Mar. 19, 2003

The Issue The issues are whether Respondent failed to maintain an accurate medication record relating to narcotic medications in violation of Section 400.419(1)(b), Florida Statutes, and Rule 58A-5.0185(3)(b), Florida Administrative Code; and if so, what penalty should be imposed.

Findings Of Fact Petitioner has authority to license assisted living facilities (ALFs) and the duty to enforce all statutes and rules governing such facilities. Respondent is a licensed ALF with a total capacity for 35 residents. Respondent's License No. AL5888 is effective March 20, 2002, through March 19, 2004. On January 31, 2002, Petitioner completed a biennial survey of Respondent's facility. During the survey, Petitioner's staff observed Respondent's staff administering medication to six residents who needed medication assistance. Resident No. 6 received a narcotic medication, in tablet form, that she was supposed to take by mouth three times daily, as needed, for pain. The medication is addictive and may be obtained only by prescription. The prescription bottle at issue here indicated that it was filled on January 21, 2002, with 100 tablets. There is no other evidence regarding the number of tablets in the bottle when it arrived at Respondent's facility. Respondent did not count the tablets in the bottle upon receiving it from the pharmacy. Resident 6's MOR showed that she received the narcotic tablet three times daily, everyday, with no missed doses during the time period at issue here. According to the MOR, Resident 6 received a total of 32 doses of the medication beginning January 21, 2002, at 7:00 a.m. through January 31, 2002, at 12:25 p.m. However, the bottle contained only 54 tablets as of January 31, 2002, at 12.25 p.m. Respondent's staff could not explain or account for the 14 missing narcotic tablets. Under cover of a letter dated February 12, 2002, Petitioner advised Respondent that the biennial survey had identified a Class II deficiency relative to Resident 6's medication administration. The letter requested Respondent to file a plan of correction within ten days. Resident 6's narcotic medication was refilled on February 19, 2002, with 100 tablets. As of March 8, 2002, Resident 6 had 51 pills remaining in the new prescription bottle. On March 8, 2002, Petitioner's staff conducted a follow-up visit to Respondent's facility. The count of tablets in Resident 6's narcotic medication prescription bottle, when compared to the MOR, was correct at that time. Under cover of a letter dated March 15, 2002, Petitioner advised Respondent that the previously cited deficiency had been corrected.

Recommendation Based on the foregoing Findings of Facts and Conclusions of Law, it is RECOMMENDED: That Petitioner enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 10th day of October, 2002, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD 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 10th day of October, 2002. COPIES FURNISHED: Michael O. Mathis, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308-5403 Alvin L. Peters, Esquire 25 East Eighth Street Panama City, Florida 32401 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308

Florida Laws (2) 120.569, 120.57

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CFSATC, INC., D/B/A CENTRAL FLORIDA SUBSTANCE ABUSE TREATMENT CENTER vs DEPARTMENT OF CHILDREN AND FAMILY SERVICES, 99-003450 (1999)

Division of Administrative Hearings, Florida Filed:Orlando, Florida Aug. 12, 1999 Number: 99-003450 Latest Update: Jul. 18, 2000

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).

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

Florida Laws (6) 120.569, 120.57, 120.60, 397.311, 397.403, 397.427 Florida Administrative Code (2) 28-106.111, 28-106.205

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BOARD OF MEDICAL EXAMINERS vs. TEOTIMO D. BONZON, 82-000799 (1982)

Division of Administrative Hearings, Florida Number: 82-000799 Latest Update: Mar. 03, 1984

The Issue The matters presented for consideration in this case concern an administrative complaint brought by the Petitioner against the Respondent. That complaint alleges violations of various provisions of Chapter 458, Florida Statutes. Those sections of law are more particularly described in the conclusions of law in this Recommended Order. In summary, Respondent is alleged, in the course of his relationship with patients under his care, to have prescribed numerous controlled substances which were in excessive amounts, and were not appropriate prescriptions for the medical problems experienced by the patients, and were not prescribed in the course of the Respondent's professional practice. In the face of these circumstances, Respondent is accused of having committed gross or repeated malpractice in failing to recognized by reasonably prudent similar physicians in his community. Respondent is also accused of having failed to keep written medical records justifying the course of treatment.

Findings Of Fact Teotimo D. Bonzon, M.D., is a physician licensed to practice medicine in Florida through licensure by the State of Florida, Department of Professional Regulation, Board of Medical Examiners, license No. MF0016786. He has held this license at all times relevant to this inquiry and during this period has practiced medicine at 830 Gary Street, Jacksonville, Florida, and 6229 Merrill Road, Jacksonville, Florida. At present, Respondent does general surgery approximately three times a week and sees 30-35 patients a day in his general office practice. Dr. Bonzon is a graduate of the medical school, Far Eastern University, Manila, the Philippines. The date of his graduation was 1961. In 1962, he took his internship at St. Francis Hospital in Jersey City, New Jersey. There followed five years of general surgery training at Booth Medical Center in Flushing, New York, and York Hospital in York, Pennsylvania. Respondent then took a year of surgical fellowship at the Community General Hospital of Syracuse, New York. Following this practice, Respondent stood examination for medical license to practice in the State of Florida, and in the States of Pennsylvania and Indiana. Having passed those examinations, the decision was made to move to Florida. Respondent arrived in Florida in June of 1971 and has been involved in the practice of general surgery and general office practice since that time. The initial two years in practice in Florida were primarily concerned with general surgery and industrial medicine, which relates to provision of care for those persons who have been injured in industrial accidents. The administrative complaint, which is the subject of this controversy, dates from March 10, 1982, and is the result of a survey made by the State of Florida, Department of number of Schedule II controlled substances per Chapter 893, Florida Statutes, which had been prescribed by physicians who practice in the Jacksonville, Florida, area. This survey transpired over a period of approximately six months, beginning in the fall of 1981. After being properly served with the administrative complaint, Respondent made a timely request for a formal hearing pursuant to Subsection 120.57(1), Florida Statutes. ARTHUR LEE SCHEIDER (Counts I, II, IV, V) Dr. Bonzon first saw Arthur Scheider in his office on May 29, 1979. At that time, the chief complaints of the patient had to do with "nerves, that the patient could not sleep, that he itched and broke out in a rash." These matters are reflected on the copy of the patient's records, which are admitted as Petitioner's Exhibit C. Additionally, it was noted that the patient had been utilizing methaqualone or Quaaludes for one year prior to being seen by Dr. Bonzon. Scheider had also been receiving Valium in 10 milligram amounts. On this date, Dr. Bonzon prescribed 100, 300-milligram Quaaludes to assist the patient in sleeping and 100, 10-milligram Valium tablets related to the nervous problem being experienced by the patient. Both of these drugs are Schedule II controlled substances with a potential for abuse by those persons for whom the prescription has been given. Methaqualone is a sleep producer. Valium is a muscle relaxer. Scheider was again seen on August 20, 1979, still complaining of nervousness and problems with sleep together with a rash condition on his torso and extremities. At that time, a further prescription of Quaaludes in the amount of 100 at 300-milligram each and Valium in the amount of 100 at 10- milligram each were prescribed for the patient with the opportunity for one refill related to the Valium. On November 1, 1979, the patient returned and based upon a diagnostic note in the patient's records to the effect that the patient needed nerve medicine, a further prescription Valium with opportunity for one refill was prescribed. These prescriptions were given on November 1, 1979, before the amounts related to the August 20, 1979, prescription for Quaaludes and Valium had been exhausted. This is based upon Dr. Bonzon's appropriate recommendation that no more than one Valium and one Quaalude tablet be taken per day. On January 7, 1980, a brother of the patient Scheider asked for Quaalude medication and was denied. The request for medication is reflected in the aforementioned exhibit related to patient records of Scheider. Scheider was again seen on March 14, 1980, complaining of laryngitis, cough, and of a fever in the range of 100 degrees. On that date, in addition to other medication, 100, 300-milligram Quaaludes and 100, 10-milligram Valium were prescribed for the patient. No explanation is made as to why Quaaludes and Valium were prescribed. On May 19, 1980, the patient record reflects that 50, 10-milligram Valium were prescribed for the patient Scheider; no indication is made as to the reason for this prescription. The Valium prescription was given at a time prior to the exhaustion of the March 14, 1980, prescription for Valium based upon a utilization rate of one Valium tablet per day. On June 11, 1980, a sister of Arthur Lee Scheider's called and spoke to the Respondent and told the Respondent that Arthur Lee Scheider had been selling Valium to Scheider's mother. As a consequence, Dr. Bonzon noted in the patient record that he would not prescribe Valium for Scheider in the future and in fact abided by this choice. Respondent did prescribe 100, 300-milligram strength methaqualone tablets on this date. On September 12, 1980, Scheider was again seen by the Respondent reference an examination which led to the conclusion that the patient needed an operation related to a circumcision. At that time, 100 additional 300-milligram Quaaludes were prescribed for the patient. Prescribed methaqualone or Quaaludes for the patient Scheider, it was always on the basis that Dr. Bonzon felt that the patient needed assistance in sleeping. Although not reflected in the medical record, Bonzon had suggested to Scheider that he see a psychiatrist in trying to combat his problem with sleep; however, Scheider declined this suggestion and the Respondent continued to prescribe methaqualone or Quaaludes. These prescriptions of 100 were made, notwithstanding the fact that the Physicians' Desk Reference indicated that methaqualone or Quaaludes should be prescribed in "small quantities." Respondent believes that this suggestion is a relative matter and really intends that the patients not be allowed to take more than one methaqualone tablet per day, an erroneous assumption. Respondent learned of Scheider's trafficking in the controlled substance, methaqualone, on November 25, 1980, and made a note in the patient's file that the patient had been arrested for this activity and that no more medication should be prescribed for this patient for drugs which were under "narcotic control." It was also indicated that appointments for this patient should pertain to other medical problems unrelated to controlled substances. Dr. Ensor R. Dunsford practices medicine in Jacksonville, Florida. He has, during his career, practiced in general surgery and is board certified in that field. His present practice involves emergency treatment in a freestanding emergency care facility. Upon examination of the patient records related to Arthur Lee Scheider, involving the prescription of methaqualone and Valium over the period May 19, 1979, through September 12, 1980, Dr. Dunsford was of the opinion that the act of prescribing was "grossly overdone." Further, Dr. Dunsford felt that this amount prescribed was risky for a patient because of the potential for abuse. If the patient has an emotional need for the substance, then the risk is there that a physical need might be created. In summary, Dr. Dunsford felt that the number of Valium and methaqualone tablets which were in the best interest of the patient. Moreover, Dr. Dunsford felt that the amounts of methaqualone and Valium which Respondent prescribed for Scheider over the period of time were not acts of a "reasonably prudent physician" related to practicing medicine with a level of care, skill and treatment performed by a similar physician in the community. Dr. Dunsford also expressed the opinion that the decision to prescribe the additional methaqualone or Quaaludes on June 11, 1980, and September 12, 1980, after receiving information that the patient was selling a controlled substance (the information of June 11, 1980, from patient's sister related to Valium) was inappropriate and a reflection of substandard medical judgment. To Dr. Dunsford, the information that was given by the sister of patient Scheider was a "red flag" waving in the face of the practitioner, Dr. Bonzon. Dr. Dunsford also states that the September 12, 1980, medical record does not establish a basis for prescribing Quaaludes related to symptomology of the patient. The record makes no reference to the problem with sleeping and pertains only to scrotal erythema, parietitis and the need for circumcision. Finally, given the facts of the prescriptions from May 29, 1979, through September 12, 1980, with emphasis on the information related to suspected drug sales which was imparted on June 11, 1980, Dr. Dunsford feels that a reasonably prudent physician would not want to be involved with that type of situation, i.e. prescribing the drugs on June 11, 1980, and September 12, 1980. All opinions, as expressed by Dr. Dunsford found above are accepted. Dr. Apolinar C. Ilano gave testimony. Dr. Ilano practices in Jacksonville, Florida, as a general surgeon. Dr. Ilano agrees with Dr. Dunsford that methaqualone has a potential for abuse. Following review of the patient records of Arthur Lee Scheider, Dr. Ilano's opinion was that some record had been made which justified the prescription of methaqualone for the sleep problem of Scheider and Valium related to the nervous problem of that patient. The justification found by Dr. Ilano does not satifactorily explain the lack of explanation for prescribing methaqualone on September 12, 1980, as referred to by Dr. Dunsford. Dr. Ilano did not feel that the amounts of methaqualone and Valium that were prescribed to Scheider were excessive or inappropriate or contrary to good judgment by reasonably prudent similar physicians in that there was some justification for prescribing the medication to be found in the record; no indication in the record that the patient was abusing Valium, as opposed to sticking to the amount or dosage prescribed, and the rationalization that Dr. Bonzon was attempting to limit the number of office visits by prescribing the high amounts of methaqualone and Valium. The opinion expressed in the prior sentence is not compelling in the face of facts presented and the more acceptable explanation offered by Dr. Dunsford. Even Dr. Ilano was concerned about prescribing methaqualone after learning that the patient was possibly selling Valium, although his opinion did not reach the level of finding fault with the quality of care offered by Dr. Bonzon in prescribing methaqualone after being informed of the possible sale of Valium, as Dr. Dunsford had. Again, Dr. Dunsford's opinion is accepted on this topic. Dr. Ilano correctly states that if the patient is selling Valium he might in turn sell methaqualone. Dr. Osbey L. Sayler gave testimony related to the care and treatment of Arthur Lee Scheider. Dr. Sayler practices in Orange Park, Florida, and is a board-certified general surgeon. The sum and substance of Dr. Saylor's opinion of Dr. Bonzon's care and treatment of Arthur Lee Scheider was to the effect that Dr. Bonzon had done nothing inappropriate as alleged in the various counts pertaining to that patient. After considering this opinion testimony and that of the other physicians, Dr. Saylor's opinions are accepted to the extent that they describe methaqualone as being an addictive or habit-forming drug which has been resorted to by persons attempting suicide and which is sold on the street as a "downer" and his opinion that Valium has a potential for abuse and can be addictive. Otherwise Dr. Sayler's opinions are rejected. GLADYS KNIGHT (Counts VI, XII, and XIII) Respondent treated the patient Gladys Knight over a period of years. During that time, the patient was seen on April 28, 1981, and was prescribed 30, 10-milligram Ritalin tablets. Ritalin is a Schedule II controlled substance. A notation of the prescription may be found in Petitioner's Exhibit D admitted into evidence, a copy of the patient records kept by the Respondent related to Gladys Knight. As established through the testimony of Dr. Dunsford, no indication is made in those records of an acceptable reason for prescribing Ritalin which is in the category of amphetamine or sympathomimetic amine drugs, spoke to in Section 458.331(1)(cc) , Florida Statutes. The underlying diagnostic impression upon the April 28, 1981, visit, according to the patient records related to complaints of the inability to get out of bed because of fatigue and insomnia. Remarks are also made in that entry that the patient is without energy and is complaining of arthritis pain in her right shoulder. None of these matters comport with a justifiable basis for prescribing ritalin as allowed in Section 458.331(1)(cc), Florida Statutes. In discussing the prescription of Ritalin, Dr. Bonzon indicated in the course of the hearing that he recognized Ritalin to be a central nervous system stimulant, which it is, and that he prescribed it for Mrs. Knight on April 28, 1981, because of his perception of signs of depression in that patient. More particularly, Dr. Bonzon indicated that she had claimed she didn't have energy, didn't want to get out of bed and was recalling a time when her husband was still alive. As a consequence, Bonzon felt that on this one occasion, in his medical judgment, Knight would benefit from a short term use of Ritalin. This was the only prescription of that substance for the patient. No mention was made in the patient record of the depressed condition; however, this impression which was given of the patient's condition in the course of the hearing is not sufficient justification for the prescription of Ritalin, "depressed state" not being one of the accepted bases for prescribing Ritalin as related in Section 458.331(1)(cc), Florida Statutes. Respondent also prescribed Preludin to the patient, Gladys Knight, commencing February 22, 1979. Preludin is a Schedule II controlled substance. This drug was prescribed for purposes of weight control. On the initial date, the patient was provided with 30 tablets with the opportunity for three refills. At that time, the patient weighed 148 pounds. The patient was seen again on August 14, 1979, for weight control and 50 Preludin tables were prescribed with the opportunity for one refill. This visit was made with a Dr. Lagman. At that time, the patient weighed 145 pounds. On September 27, 1979, the patient was seen by the Respondent and was given a further prescription of Preludin to control her weight. She weighed 143 pounds upon that visit. On December 3, 1979, the Respondent saw the patient again and prescribed Preludin in the amount of 100 tablets for weight control. At that time, the patient weighed 146 pounds. Finally, the patient was seen by the Respondent on February 14, 1980, her weight was shown to be 143 pounds and she was given a further prescription of Preludin in the amount of 100 tablets. This was on prescription by Respondent. Knight had been instructed by the Respondent on the occasion of prescribing Preludin on the question of how to utilize the Preludin tablets. At the time Respondent prescribed Preludin for patient Knight, he was unaware that the drug was an amphetamine or sympathomimetic amine drug. Respondent also discovered that Preludin prescriptions could not be refilled when a pharmacist contacted him in August of 1979 reference an effort by Knight to refill a prescription. Dr. Dunsford had reviewed the patient records related to Gladys Knight, particularly as it related to the prescription of Preludin. He identified that Preludin has been prescribed to assist obese people in weight control through the devise of suppressing the appetite of those patients. Because of a potential for abuse, Preludin is only prescribed for utilization over a period approximating a few weeks, per Dr. Dunsford. His testimony about Preludin, related to utilization, appropriate limits of its use, and potential for abuse is accepted. Dr. Dunsford felt that the Preludin had been over prescribed in the sense of amounts being too large on each prescription and over too long a period of time. Dr. Dunsford placed particular emphasis on the lack of wisdom in prescribing 100 tablets of Preludin on one occasion and felt that would be excessive and inappropriate. These opinions are accepted. Moreover, the opinion by Dr. Dunsford that the pattern of prescribing Preludin for Knight were not the actions of a reasonably prudent physician, under similar conditions and circumstances, is found to be correct. Dr. Ilano did not feel that the amount of Preludin was excessive nor did he feel that the actions of the Respondent constituted a failure to practice medicine with the care and skill that a reasonably prudent physician, under similar conditions and circumstances, would pursue. Dr. Ilano's opinion is not accepted. Nor is the opinion of Dr. Saylor related to the treatment of Mrs. Knight utilizing Preludin found to be compelling when he speaks favorably to treatment choices by the Respondent. JOHN BROUGHTON (Counts VIII, IX, X and XI) John Broughton was a patient of the Respondent in the time period August 13, 1979, through February 16, 1981. Records related to the treatment of Broughton are found as part of the Petitioner's Exhibit E admitted into evidence. During the treatment of Broughton, beginning on August 13, 1979, 40 Preludin, 75-milligram tablets were provided for weight control. Preludin, 75- milligrams was again prescribed for control on September 21, 1979, following examination by Respondent. On October 31, 1979, Dr. Bonzon saw Broughton and prescribed Preludin 75-milligram in the amount of 60 tablets related to weight control. On December 31, 1979, an additional 80 tablets of 75-milligrams Preludin was prescribed by Respondent for the benefit of Broughton. On March 13, 1980, 100, 75-milligram preludin tablets were given to Broughton on prescription issued by Respondent. On June 4, 1980, 50, 75-milligram Preludin tablets were prescribed by Respondent for Broughton. Respondent denied Broughton a request for Preludin upon an office visit on July 28, 1980, to see how the patient would react without the drug. On November 3, 1980, Preludin, 75-milligrams in the amount of 40 tablets was prescribed by Respondent for Broughton for weight control and a notation made that no further prescription would be written unless 40 days had transpired. On December 11, 1980, without examining the patient, Preludin was prescribed for an unidentified condition. The strength of the Preludin was 75-milligrams and 50 tablets were authorized by the prescription issued by Respondent for the benefit of Broughton. Other evidence in the hearing demonstrates that this Preludin was prescribed for weight control on that visit. During the course of the treatment, Broughton lost approximately 20 pounds in weight. In the interval of treatment, Broughton had requested Respondent to prescribe additional Preludin tablets and had been advised by Respondent that they would not be forthcoming based upon the fact that sufficient time had not transpired to have utilized one tablet per day on the previous prescription. In addition, the Preludin was not prescribed for Broughton if his blood pressure was too high upon examination by Dr. Bonzon. At the time Dr. Bonzon prescribed Preludin in November and December, 1980, as identified before, he was unaware that Preludin, an amphetamine or simpathomimetic amine drug, could not be prescribed for weight control after July 3, 1980. 1/ On August 13, 1979, Talwin was prescribed for Broughton by the Respondent upon an office visit. The explanation for this prescription says for "hip." In particular, it related to the provision of pain medication. Talwin, as with the case of Preludin, is a Chapter 893, Florida Statutes, controlled substance with addictive qualities. Talwin is, in effect, a pain medication. On September 21, 1979, a further prescription of Talwin was prescribed by Respondent for Broughton upon an office visit. This Talwin in 15-milligram strength, 40 tablets with opportunity for a single refill. No indication was made in the record as to the basis for prescribing this pain medication. Between August 13, 1979, and September 21, 1979, there is a notation in the patient records effective August 28, 1979, of a refill of Talwin in 50-milligram strength, 30 tablets and a further indication of Talwin being prescribed, 50- milligram strength, 30 tablets on September 13, 1979. On November 8, 1979, the patient record shows a refill of Talwin in the amount of 50 tablets. On November 16, 1979, the file establishes that the patient said he had been caught in the rain and his bottle got wet and that the Talwin turned to mush and a prescription was written in the amount of 50 Talwins to replenish Broughton. Broughton verified this story in the course of his testimony at hearing. The pills had not been destroyed but the Respondent did not know this at the time the prescription was written on November 16, 1979. The records reflect a notation on that date that no refills of Talwin should be given until November 28, 1979. On December 31, 1979, the patient was seen by Respondent for a problem he was experiencing with a hernia condition and a cough, congestion, and headaches. On that date, Talwin in, the 50-milligram strength, 50 tablets was prescribed. On the dates January 22, 1980; February 10, 1980; and February 28, 1980, patient records show prescription of Talwin in the 50-milligram strength, 50 tablets on each of those dates. The patient was seen by Dr. Bonzon on March 30, 1980, complaining of the hernia condition and a prescription was written for 50 Talwin, 50-milligram tablets. On June 4, 1980, the Respondent saw Broughton and prescribed 50 Talwin in 50-milligram strength. On July 28, 1980, Respondent saw Broughton and discussion was made of establishing surgery for hernia repair. Talwin was prescribed in a 50-milligram strength, 50 tablets with an indication of no refill, as established in the patient records. On August 25, 1980, an indication is made in the patient records that Talwin, 50-milligram strength in the amount of 40 tablets was prescribed for the patient. On October 10, 1980, patient records show that Talwin was refilled. On November 10, 1980, patient records reflect that a Pic N Save Drug Store had received a request for refill of Talwin in the amount of 40 tablets and this request was denied by the doctor's office based upon the fact that a refill had just been given on November 3, 1980. On November 20, 1980, the records reflect that the Pic N Save at Sandlewood was given a prescription of Talwin, 50-milligram strength in the amount of 40 tablets for benefit of Broughton. On December 8, 1980, the patient was seen by Respondent. It was noted in the record that Talwin in the strength of 50-milligrams, 20 tablets had been prescribed two days before. Other evidence does not clarify whether that prescription was indeed written. On December 19, 1980, the patient records reflect that Talwin in the strength of 50-milligrams, 50 tablets was prescribed. On January 9, 1981, the records reflect Talwin, 50-milligram strength, 40 tablets was prescribed. On January 19, 1981, the record reflects Talwin, 50-milligram strength, 40 tablets was prescribed. On February 2, 1981, a notation is given that the patient has injured his leg and had received a night appointment and has reported using all the Talwin due to intense pain. Further indication is that Talwin in the amount of 50-milligram strength, 10 tablets was prescribed. A second entry related to February 2, 1981, is made having to do with a visit in which Respondent examined Broughton. He found the leg on the right calf highly inflamed and two large hemotomas and that the patient was experiencing pain and for this condition, Talwin in the amount of 50-milligram strength, 50 tablets was prescribed. On February 11, 1981, a final notation indicates a refill of Talwin and the establishment of an appointment for the following day. That appointment was not kept. On February 16, 1981, the Talwin was ordered refilled. A notation was made at that time that the patient had not been keeping his appointments because of money owed and an expression of the importance to come in even if he could only pay a portion of the bill and a notation that the patient was using too much Talwin. All record notations are accepted as accurate depictions of events reported. Eventually, Broughton was picked up for criminal offenses related to controlled substances and was imprisoned. Unknown to Respondent, Broughton had given Talwin and Preludin which had been prescribed for him through Respondent to other persons. Following his release from incarceration, Respondent has refused to see Broughton. Although the records do not reflect the specific basis for prescribing Talwin in the questioned period, August 13, 1979, through February 16, 1981, other than the occasions of the hip and leg injury to his calf, it has been extrinsically established that Talwin was prescribed for pain related to a hernia condition, at times beginning December 31, 1979, and forward. There is other indication that the patient Broughton had sustained an injury to his coccyx and had some sacro coccygeal pain; however, it is unclear whether the Talwin was prescribed for that condition in the questioned period. Moreover, by May 20, 1980, Dr. Bonzon is expressing the opinion that physical examination of Broughton was negative regarding sacro coccygeal pain. The patient's records do indicate on March 11, 1977, complaints of Broughton with his tail bone or coccyx because of a fall in a Pantry Pride store in San Diego, California. On the subject of Broughton's involvement with drugs, in an interview held in November 1981, Respondent told John E. Danson, an investigator with the Department of Professional Regulation, that he thought Broughton was a drug addict because on one occasion, Broughton had offered him $50 to prescribe Dilaudid, a Schedule II controlled substance, at which time Broughton had been asked to leave Bonzon's office. Dr. Dunsford examined the records of treatment received by Broughton found in Petitioner's Exhibit E and gave the opinion that the amounts of Preludin and Talwin prescribed to Broughton in the time frame described were excessive and inappropriate. The prescription of those drugs over this period of time was not in the best interests of the patient according to Dr. Dunsford and not the actions of a reasonably prudent similar physician dealing with a patient under similar circumstances and conditions, on the subject of the skill and treatment afforded to this patient. As described by Dr. Dunsford, both Talwin and Preludin have addictive qualities. Dr. Dunsford did not feel that the pain the patient Broughton had experienced was sufficiently severe to warrant the number of Talwin tablets received. Continued response to the patient's request for more Talwin was in the words of Dr. Dunsford "bad." Dr. Dunsford also observed that the prescription of Preludin in November and December 1980, was not based upon any of the health conditions described in Section 458.331(1)(cc), Florida Statutes. The overall records of Dr. Bonzon related to the prescriptions of Talwin and Preludin, with particular emphasis on the December 11, 1980, prescription were deficient as it relates to a justification of continuing the regimen of prescribing these substances, according to Dr. Dunsford. The observations and opinions of Dr. Dunsford found in this paragraph are accepted. Dr. Ilano examined the records related to Broughton and did not find that Respondent's treatment was unacceptable. Likewise, Dr. Saylor did not find the treatment of Broughton to be unacceptable. The opinions by these doctors are not accepted. COUNTS XIV and XV Between July 1, 1980, and December 31, 1980, Respondent prescribed approximately 15,260 controlled substances constituted of Percodan, Percocet, Tuinal, Preludin, Tylox, Quaalude, Ritalin, Demerol, Merperganfortis, Biphetamine, Sopar, Eskatrol and Dilaudid. With the exception of these substances related to the patients Scheider, Knight, and Broughton, no notation has been made that these drugs were prescribed, dispensed or administered in excessive or inappropriate amounts i.e., the 15,000 number is not excessive and inappropriate "on its face," nor is this raw number an indication that Respondent has failed to practice medicine with a level of care, skill and treatment which is recognized by a reasonably prudent, similar physician as being acceptable under similar conditions and circumstances.

Florida Laws (2) 120.57, 458.331

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BOARD OF MEDICAL EXAMINERS vs. KOA-SHUN WU, 83-002181 (1983)

Division of Administrative Hearings, Florida Number: 83-002181 Latest Update: May 08, 1990

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 =================================================================

USC (1) 21 CFR 291.505 Florida Laws (2) 120.57, 458.331

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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs RICARDO JOSE SABATES, M.D., 10-002124PL (2010)

Division of Administrative Hearings, Florida Filed:West Palm Beach, Florida Apr. 19, 2010 Number: 10-002124PL Latest Update: Dec. 25, 2024

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BOARD OF PHARMACY vs. BGJM, INC., D/B/A SAVE ON DRUGS, ET AL., 82-002095 (1982)

Division of Administrative Hearings, Florida Number: 82-002095 Latest Update: Sep. 06, 1983

Findings Of Fact The Petitioner is the Department of Professional Regulation, Board of Pharmacy. Petitioner seeks to suspend, revoke or take other disciplinary action against the Respondents. Respondent BGJM, Inc. (hereinafter "Save-on Drugs") holds Permit No. 7171 located at 4282 North State Road 7, Lauderdale Lakes, Florida. Save on Drugs has held said permit at all times material hereto. Respondent Robert E. Levy holds Pharmacy License No. 0017283 and has held said license at all times material hereto. Respondent Levy operated Save on Drugs as the sole proprietor and is the only pharmacist employed at the aforementioned store. Respondent Levy, while working at Save on Drugs, between the dates October 16, 1981 and April 2, 1982, dispensed approximately 139,000 Methaqualone tablets on 3,136 prescriptions. Respondent Levy ceased dispensing Methaqualone tablets approximately three (3) weeks prior to the institution of Petitioner's investigation of Respondent Levy's dispensing of controlled substances. The Respondent dispensed, over a three-month period, some 57,250 units of Methaqualone on behalf of one practitioner, a Dr. Lena. A specific breakdown of Dr. Lena's prescribing activity for part of the relevant period is as follows: DATE PHARMACY DRUG AMOUNT SCRIPT 12/14/81 Save-On Quaa-300 mg. 630 14 12/15 Save-On 720 16 12/16 Save-On 495 11 12/17 Save-On 765 17 12/18 Save-On 1,440 32 12/21 Save-On 945 21 12/22 Save-On 1 x 30 mg. 675 15 12/23 Save-On incl. 1,080 24 12/24 Save-On 1,215 27 12/28 Save-On 1,035 23 12/29 Save-On 1,305 29 12/30 Save-On 1,575 35 12/31 Save-On 1,305 29 Totals 13,185 293 The numerous prescriptions introduced into evidence by the Petitioner reflect circumstances where Respondent Levy failed to properly initial and date Schedule II prescriptions as they were filed. As example, Petitioner offered the following: prescription Nos. 48854, 48052, 50189, 48068, 48856, 48912 and 48905. Louis Fisher 2/ , an employee of the Department of Justice, Drug Enforcement Administration, since approximately November, 1971, has been involved with the regulation of controlled substances. Mr. Fisher works with doctors as well as pharmacists at the retail level. Mr. Fisher is a registered pharmacist and has been charged with drafting regulations for controlled substances. Without question, Methaqualone is a Schedule II drug and is a sedative and hypnotic agent. The drug has a high abuse potential. During the summer of 1982, Methaqualone was changed from Schedule II to a Schedule I controlled substance. After being provided with a hypothetical situation giving the number of prescriptions that Respondent Levy had filled during the time period involved, Mr. Fisher concluded that a pharmacist filling the number of prescriptions within the time period as is here involved by Respondent Levy was, in Mr. Fisher's opinion, unprofessional, excessive, outside the course of good professional practices, and not conduct amounting to professional practice in the patients' best interest. 3/ Dr. Lena was employed by Northeast Medical Services, a stress clinic. In this regard, the parties stipulated that all the prescriptions involved herein were written by a licensed medical doctor. Daniel O'Connell, an investigator with the Department of Professional Regulation, visited the Respondent's store during approximately October 1981, and performed a routine change of ownership inspection. At that time, Respondent Levy engaged in a conversation with investigator O'Connell at which time Respondent Levy was apprised of the problem with respect to dispensing Methaqualone in the south Florida area. Jim R. Golden, an investigator with the Department of Professional Regulation since approximately September 1981, visited Respondent Levy's store during April 1982, to perform a routine inspection to determine the amount of Schedule II drug prescriptions that Respondent was filling. Investigator Golden reviewed a large number of prescriptions that were filled by Respondent for Dr. Lena and inquired of Respondent the reason for dispensing such a large number of prescriptions for Methaqualone tablets. Respondent Levy replied that it was the "money end of it" and that he (Respondent) could fill six (6) Methaqualone prescriptions and do better with those prescriptions from a profit viewpoint than he could with the remainder of his other prescribing activities in the store for the remainder of any given day. Further, Respondent related that he hand to do extensive repairs to make the store operational. (Testimony of Investigator Golden)

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED: That Respondent BGJM, Inc.'s Permit No.7171 be REVOKED. That Respondent Robert E. Levy's Pharmacy License No. 0017283 be placed on probation for a period of two (2) years. RECOMMENDED this 12th day of May, 1983, in Tallahassee, Florida. JAMES E. BRADWELL, 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 12th day of May, 1983.

Florida Laws (4) 120.57, 465.018, 465.023, 893.04

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BOARD OF PHARMACY vs. SHARON DRUGS, D/B/A MERCY PROFESSIONAL BUILDING, 76-001702 (1976)

Division of Administrative Hearings, Florida Number: 76-001702 Latest Update: Feb. 25, 1977

Findings Of Fact The parties stipulated that Monroe C. Schiffman is a pharmacist licensed by the Florida Board of Pharmacy. They further stipulated that Sharon Drugs d/b/a Mercy Professional Building Pharmacy is located at 3661 South Miami Avenue, Miami, Florida and that Sharon Drugs owns and operates Mercy Professional Building Pharmacy. The parties also stipulated that Monroe C. Schiffman was a corporate officer and shareholder in Sharon Drugs, Inc., a Florida corporation, from February 1, 1975 until the dates of the audits in question and that Monroe C. Schiffman was a corporate officer and stockholder in Monroe Pharmacy, Inc. from March, 1974, until the audits in question. An inspection and audit of Sharon Drugs, Inc. d/b/a Mercy Professional Building Pharmacy, was begun on April 23, 1976 and lasted for several days. The audited period was from March 17, 1975 until April 26, 1976, during which dates Monroe C. Schiffman was the registered pharmacist responsible for the operation of Sharon Drugs, Inc. The procedures for the audits were to assume a zero stockage as of March 17, 1975 and to account for the drugs received after that date. The drugs audited were controlled drugs as defined by Chapter 893, Florida Statutes. These drugs were chosen for audit because complete records of their order, receipt and dispensing must be kept pursuant to Chapter 893, Florida Statutes. Exhibit 1, a summary of the audit of Sharon Drugs, Inc., was identified by the Board's agent, Vernon K. Bell, as the summary of the discrepancies in controlled drugs revealed by the audit which he conducted. The audit conducted by Vernon K. Bell revealed a shortage of controlled drugs for which no records had been kept of 296,481 total units or pills. The drugs audited were Desoxyn (methamphetamine hydrochloride), Tuinal (sodium amobartital and sodium secobarbital), Biphetamine (d- and dl-Amphetamine), Dilaudid (hydromorphone), Nembutal (sodium pentobarbital ), Seconal (sodium seconbarbital), Quaalude (methaqualone), Eskatrol Spansule (dextroamphetamine sulfate and prochlorperazine), and Dexedrine (dextroamphetamine sulfate). The records required to be kept by law of the dispensing of controlled drugs were not kept by the permittee, Sharon Drugs, Inc., d/b/a Mercy Professional Building Pharmacy, M.C. Schiffman.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the permit of Sharon Drugs, Inc. d/b/a Mercy Professional Building Pharmacy and Monroe C. Schiffman be revoked. DONE and ORDERED this 5th day of January, 1977, in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings Room 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Michael Schwartz, Esquire Suite 201, Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 H. F. Bevis, Executive Secretary State Board of Pharmacy 252 East Sixth Avenue Box 3355 Tallahassee, Florida 32303 Gerald Kogan, Esquire Suite 500 Security Trust Building 700 Brickell Avenue Miami, Florida 33131

Florida Laws (2) 893.04, 893.07

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