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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) 120.57458.331893.03893.05
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REBECCA B. MCCALL vs DEPARTMENT OF HEALTH, BOARD OF NURSING, 98-000470 (1998)
Division of Administrative Hearings, Florida Filed:Jacksonville, Florida Jan. 29, 1998 Number: 98-000470 Latest Update: Dec. 26, 2000

The Issue Whether Petitioner's nursing license should be reinstated.

Findings Of Fact Petitioner was first licensed as a registered nurse on March 28, 1977. Throughout, Petitioner has renewed her license by paying her bi-annual license fees. Petitioner's renewals have included times when her license was suspended. At the time of the hearing, Petitioner's license was active but suspended. The license was also delinquent for Petitioner's failure to pay her 1998 bi-annual renewal fees. The license was not inactive. Since the hearing, Petitioner's license has been nullified. In her teens, Respondent suffered a serious and permanent injury to her neck and back in an automobile accident. The injury caused and still causes chronic pain, including migraines and neck pain. Because of her pain, Petitioner was prescribed opiates in her teens. By her twenties, Petitioner was addicted to those opiates. Petitioner's drugs of choice were Demerol and Dilaudid. She has been advised that her neck pain will get worse over time. Subsequent to Petitioner's initial licensure, Petitioner accumulated an extensive criminal history related to her drug use. Her criminal history includes petty larceny, attempting to obtain dilaudid by fraud, attempting to obtain a controlled substance by fraud, possession of a controlled substance, smuggling drugs into a prison, and smuggling drugs into a rehabilitation facility. On April 15, 1977, less than a month after her initial licensure, the Department of Professional and Occupational Regulation filed an Administrative Complaint against Petitioner (DOAH Case No. 77-0782), which alleged that Petitioner forged four prescriptions for a controlled substance and that Petitioner admitted to abusing Demerol. Following a hearing on the Administrative Complaint, the Hearing Officer found Petitioner in violation of Sections 464.21(1)(b) - unprofessional conduct, (c) - habitual intemperance or addiction to the use of controlled substances (d) - engaging in the possession of controlled substances for other than legitimate purposes, (f) - exhibiting behavior which the board has reason to believe is due to poor physical or mental health and which creates an undue risk that the person would cause harm, and (g) - willfully or repeatedly violating any of the provisions of Chapter 464, or the laws of this state, Florida Statutes (1977). Upon consideration of the Recommended Order, the Board entered an Order revoking Petitioner's license on August 27, 1977. On August 6, 1980, the Board considered Petitioner's first application for reinstatement of her license. The Board denied reinstatement until Petitioner appeared before the Board and documented her present fitness to safely engage in the practice of nursing. On December 4, 1981, the Board considered Petitioner's second application for reinstatement. Petitioner appeared before the Board and submitted a psychological evaluation and supporting correspondence attesting to her rehabilitation. The Board reinstated Petitioner's license on two years' probation. The probationary terms included random blood and urine drug screens, continued rehabilitation counseling with periodic progress reports, and quarterly employee reports. The IPN had not been created at that time. On October 14, 1983, Petitioner executed a Petition For and Notice of Voluntary Relinquishment of License pursuant to Case Nos. 0022916, 0024200, 0028839, and 0031766. Petitioner relinquished her license in the face of charges for allegedly being on duty while under the influence of drugs, introducing controlled substances into a correctional or penal institution by possession of controlled substances, abandoning patients, failing to obey a lawful order of the Board, and being incapable of practicing nursing with reasonable safety to patients by virtue of mental illness, drunkenness or use of drugs. This relinquishment coincided with the first time Petitioner went to prison on drug-related charges. On April 17, 1984, the Department of Professional Regulation filed an Administrative Complaint in Case Nos. 0022916, 0024200, 0028839, and 0031768 alleging failure to comply with probation because the required periodic reports had not been submitted, Petitioner's refusal to submit to a drug screen, testing positive for Dilaudid without a prescription, abandoning patients on two occasions, possession of controlled substances, and use of Demerol while on duty. The Administrative Complaint charged Petitioner with violation of Sections 464.018(1)(f) - unprofessional conduct, (g) - engaging or attempting to engage in the possession of a controlled substance for other than legitimate purposes, (h) - being unable to practice nursing with reasonable skill and safety to patients by reason of use of drugs, and (i) - failing to report to the Department any person whom the licensee knows is in violation of this chapter, Florida Statutes (1981). The Petition for Voluntary Relinquishment not having been presented to the Board, in consideration of the Administrative Complaint on October 19, 1984, the Board again revoked Petitioner's license. The order of revocation was vacated on June 5, 1986, and the voluntary relinquishment entered nunc pro tunc. In 1989, Petitioner had begun methadone treatment for her drug addiction. Methadone is a schedule II controlled substance. At certain therapeutic levels, methadone does reduce or eliminate a person's craving for drugs. However, at non- therapeutic levels, methadone is a potent hallucinogenic and narcotic which does impair the user's abilities and judgment. IPN was started in 1984. IPN serves as an alternative to discipline for nurses with impairments. Impaired nurses are referred to IPN by employers, nurse executives, human resource people, and the Board of Nursing. The first step in entering IPN is an evaluation with an IPN-approved evaluator. IPN does not provide evaluation or treatment. Administrative rules outline the criteria for the minimum standards for providers. An IPN-approved evaluator is required to ensure the evaluator has a background in addictions or mental health, and understandably safety-sensitive issues related to impaired health care practitioners. The evaluator makes a recommendation on the type of treatment or intervention appropriate to the individual nurse. The recommendation takes into account complicating issues such as chronic pain. Chronic pain is an issue because use of other mood-altering chemicals puts the nurse at risk for relapse into addictive disease. Treatment decisions are made by the evaluator, not IPN. Upon receipt of the evaluation, IPN coordinates with the individual nurse to set him or her up in the recommended treatment until treatment is complete. The nurse returns to IPN for monitoring. The terms of monitoring are based on the recommendations of the evaluator or treatment provider. The evaluation also addresses fitness to practice. Fitness to practice is critical and is monitored on an ongoing basis after the initial evaluation. Using the recommendations, IPN formulates an Advocacy Contract which includes the evaluator/treatment provider recommendations, such as individual psychotherapy, as well as standard provisions of participation. Standard provisions of participation include after-care following treatment, participation in weekly nurse support groups, participation in self-help groups such as AA or NA, and random urine drug screens. The standard provisions are based on a national standard. The purpose of the nurse support group is twofold: to provide support to the individual nurse, in such areas as with problem-solving and nursing related issues, and to keep IPN abreast of possible relapse behaviors by participants and the consequent safety to practice issues. On June 14, 1990, the Board considered Petitioner's third application for reinstatement, including evaluations by Randall Greene, D.O. Dr. Greene recommended that, given Petitioner's personality characteristics and the severity and progression of Petitioner's discipline she would never be able to return to clinical nursing without risk of relapse, and would need to be on probation throughout her professional career. Based on Dr. Greene's evaluations, the Board reinstated Petitioner's license under a stayed suspension. The stay of suspension was conditioned on entry into and participation in the IPN. Failure to remain in and successfully complete IPN would result in lifting of the stay and require Petitioner to appear before the Board and document her safety to practice nursing. Pursuant to IPN procedures, on June 19, 1990, Petitioner was evaluated by Molly Webb-Beatty at Vista Pavilion in Gainesville. Ms. Webb-Beatty's prognosis for a relapse-free recovery was extremely guarded due to Petitioner's 20-year opiate dependency and reported chronic back pain. Ms. Webb- Beatty reported that Petitioner chose to continue the slow dose reduction of methadone use as prescribed by her methadone treatment provider. Petitioner would contact Vista Pavilion when she neared the 20 milligram-level for possible detox and treatment with IPN. Petitioner entered into an Advocacy Contract with IPN. At that time the standard Advocacy Contract period was two years. Petitioner's Advocacy Contract specifically stated that participation dates in IPN would be set after Petitioner detoxed off methadone at a dose reduction of one to two milligrams per week. In 1990, IPN had an abstinence based policy. IPN did not recognize Methadone treatment as a legitimate alternative treatment for drug dependency. Therefore, Petitioner was required to be in the detoxification process to enter IPN. The Board's and IPN's 1990 abstinence policy was based on the American Society of Addiction Medicine's (ASAM) national standard of treatment for chemical dependency. ASAM is a nationally recognized authority in the area of addiction and addiction treatment. It certifies physicians in addiction medicine and sets treatment standards. Currently, the policy of ASAM is that the goal of addiction treatment is generally abstinence. However, methadone treatment is recognized as a legitimate alternative to abstinence in exceptional cases. IPN approved Petitioner to practice nursing in a non- clinical setting within six months of entering IPN. On July 11, 1990, Petitioner requested an appearance before the Board on the grounds that IPN was unaware of or did not understand her methadone treatment. By a Final Order on Reinstatement filed October 24, 1990, the Board of Nursing reinstated the relinquished license of Petitioner on a stayed suspension. The stay was conditioned upon Petitioner's participation in the IPN. Failure of the Petitioner to remain in IPN would result in lifting of the stay and imposition of the suspension. Petitioner proceeded with the detoxification process for several months until she became pregnant, at which time detoxification was stopped. After delivery of her child, Petitioner started the detoxification process again, but became uncomfortable and resistant to the idea of detoxification. As a result, IPN arranged in 1992 for a new evaluation to address the methadone issue. IPN sent Petitioner to Dr. Ken Thompson, certified as an addictionist by ASAM. Dr. Thompson expressed concern about the stability of Petitioner's recovery program and recommended that Petitioner participate in IPN until she was fully off methadone for two years, no clinical nursing practice until fully tapered off methadone (although it would be a clinical decision by her treating physician whether tapering off methadone is appropriate), and continued evaluation. IPN approved Petitioner to continue practice in a non- clinical setting. In 1993, IPN offered Petitioner another opportunity for evaluation of her methadone maintenance status and a possible return to clinical nursing. IPN sent Petitioner to Dr. Michael Sheehan. Dr. Sheehan, who is certified in addiction medicine, evaluated Petitioner on August 18 and December 13, 1993. Dr. Sheehan agreed with Dr. Thompson and Dr. Greene that Petitioner was unable to pursue unsupervised nursing, and should not have access to narcotic medications. He also recommended continued participation in IPN and an indefinite probation due to her continued use of a Schedule II controlled substance. Dr. Sheehan believed that Petitioner could enter clinical nursing practice with these restrictions, even with continued methadone maintenance. Dr. Sheehan did also offer, as an alternative, very slow reduction in methadone in and effort to detox Petitioner. Dr. Sheehan's evaluation was the first time any evaluator or treatment provider had suggested Petitioner should remain on a methadone maintenance program rather than detoxifying to total abstinence. The opinion was given at a time when attitudes toward methadone treatment was changing both nationally and in Florida. Subsequent to this evaluation, Linda Smith, Executive Director of IPN, began researching the issue of clinical practice by persons maintained on methadone. She contacted authorities within the state. She also researched other states to determine what their methadone policies were. Ms. Smith found that only New York was permitting health care practitioners to continue methadone maintenance while practicing health care. IPN also brought the issue of clinical practice to the Board of Nursing in 1994. At that time, the Board's position was an IPN should be abstinence-based due to safety to practice issues. Over time, Petitioner became less and less compliant with the provisions of her IPN Advocacy Contract. She was transferred to a new nurse support group due to the lack of tolerance of her treatment modality in her original group. During 1994, Petitioner refused to attend her nurse service group for several weeks at a time. For example, Petitioner did not attend in December and missed most of January 1995. IPN attempted to work with Petitioner regarding attendance at nurse support groups. When an issue of negative attitude with regard to methadone surfaced, IPN approved a transfer to a new support group and talked to the new group facilitator to make sure it would not be an issue. Petitioner complained about the difficulty in coordinating schedules between the support group and her work. IPN discussed options with her for working out her schedule, but insisted that she would have to take responsibility for implementing such arrangements since there were no other support groups available in her area. Petitioner was also required to submit urine drug screens to IPN. Until 1994 Petitioner's drug screens were collected at Quad County, Petitioner's methadone treatment location. In 1994, IPN changed its system for random urine drug screens to standardize the screens in terms of collection and the number of drugs for which the screen would be tested. Prior to that time, each participant dropped urine samples for screening at a location to be determined on an individual basis. The locations were not standardized, and the screens often did not test for Demerol, the number one abuse opiate. In 1994, participants were required to have a comprehensive health care practitioner screen done, which included Demerol, the most commonly abused opiate, as well as drugs the literature indicated were increasing in abuse, such as Vicodan, Dilaudid and Ultra-Sound. Drug screens would be done at a facility approved by IPN which ensured the chain of custody of the tests, and allowed IPN to receive the screens within 48 hours in the IPN offices. The new policy brought IPN in line with the national standards for randomized drug screens. Ms. Smith was familiar with the drug screens being done at Quad County, which were not comprehensive enough to meet IPN standards. In addition, the drug screens were not received contemporaneously in the IPN office, so IPN was not aware of Petitioner's continued legitimate use of Darvocet. Petitioner refused to comply with the standardized drug screen system. Petitioner failed to show for her drug screen tests on June 8, 1995, July 28, 1995, September 11, 1995, and October 24, 1995. Petitioner testified that she refused to participate in the standardized drug screen system on the advice of her lawyer. In 1995, IPN again brought the issue of clinical practice to the Board of Nursing. At that time the Board agreed that there may be individual nurses whose preferred treatment modality was methadone rather than abstinence; however, those nurses could only work in a non-clinical setting. On November 3, 1995, Petitioner was dismissed from IPN for non-compliance with the requirements of the impaired practitioner program. On November 8, 1995, IPN notified the Board that Petitioner was dismissed from IPN due to a pattern of noncompliance during her IPN participation, with an extensive summary of Petitioner's participation in the program. She was not dismissed because of her refusal to detoxify from methadone. In February 1996, Petitioner appeared before the Board, represented by attorney A. Bice Hope, on IPN's recommendation to lift the stay of suspension. By a Final Order No. AHCA 96-00405, filed April 3, 1996, the Board lifted the stay of suspension and suspended Petitioner's license. Again the suspension would be stayed if Petitioner entered and participated in IPN. Petitioner filed an appeal of Final Order No. AHCA 96- 00405. The Final Order was affirmed per curiam by the First District Court of Appeals in McCall v. Agency for Health Care Administration, Board of Nursing, Case No. 96-01678, Opinion filed March 11, 1997 and Mandate dated April 24, 1997. At the hearing, Petitioner attempted to dispute the issue of whether or not she was in compliance with her IPN Advocacy Center at the time of her suspension in 1996. However, the issue of whether she was in violation of the Board's order by failure to comply with her advocacy contract has already been decided by the First District Court of Appeal in its per curiam affirmance of the Board's final order. On October 8, 1997, the Board considered Petitioner's fourth application for reinstatement of her license. Petitioner requested that her license be reinstated without IPN participation, and that she be permitted to practice in clinical nursing. The Board found that the probation proposed by Petitioner was not a reasonable alternative to participation in IPN, and further found that she had not demonstrated she was capable of practicing nursing with reasonable skill and safety. Therefore, the request for reinstatement was denied. In 1998, Dr. Sheehan testified that methadone treatment does not eliminate the risk of relapse for a person addicted to narcotic drugs. He was unable to say definitely that a person not on methadone has a higher risk of relapse than a person being maintained on methadone. Indeed, the risk of relapse is always present for any addict regardless of treatment. However, Petitioner's chronic pain makes it more likely that she may relapse. Dr. Sheehan recommended that Petitioner continue participation in a 12-step program (e.g. Narcotics Anonymous) for the rest of her life. It is reasonable under these circumstances for the Board to require reports from a treatment provider. It is reasonable to require monitoring as long as Petitioner is in a clinical practice setting, with ongoing evaluation of her performance and reports to IPN or the Board on a monthly or bimonthly basis. Random urine drug testing through IPN is appropriate for Petitioner. In addition, Dr. Sheehan recommends participation in a nurse support group, particularly if Petitioner is in clinical nursing, to obtain support from Petitioner's peers. However, that group should be a group which accepts methadone treatment. IPN, on the other hand, has a clinical staff that includes individuals with master's degrees in nursing or mental health qualified employee fitness program professionals and certified addictions professionals. All of the clinical staff has experience in addiction and mental health, which is a job requirement. Facilitators for IPN nurse support groups are expected to understand the issues of addiction, mental health, and group process. Facilitators also receive training in relapse prevention. Because of IPN's expertise in impairment issues of nurses that the Board relies on IPN. The Board's requirement that IPN be involved in Petitioner's treatment and reinstatement is reasonable. Again in 1998, IPN presented the issue of methadone maintenance and clinical practice to the Board. While formulating a policy in this regard, Ms. Smith discussed the policy with Dr. Thompson who had previously evaluated Petitioner and recommended that Petitioner not engage in clinical practice unless she met with certain conditions. Those conditions included monitoring by an addiction specialist; participation in other aspects of a recovery program not solely those for methadone treatment, including therapy, similar groups, and urine drug screening; and performance evaluation. Dr. Thompson did not change his recommendation of indefinite monitoring. These recommendations reflect the changed attitude among addiction professionals regarding methadone maintenance. In August 1998, the Board and approved the new IPN policy on methadone maintenance. The policy incorporated the ASAM policy that abstinence should be the goal of choice for chemical dependency, but may not be feasible for all opiate- dependent persons. Further, the policy required that methadone maintenance treatment include behavioral, psychodynamic and 12- step approaches combined with pharmacological intervention to provide a broad spectrum of treatment. IPN guidelines for acceptance and participation of methadone patients include: the opinion of two ASAM-certified addictionists that methadone rather than abstinence is the treatment of choice for the individual nurse; the demonstrated inability to detox from methadone by the individual nurse; on-going psychotherapy with an approved specialist; demonstration of nursing competence through performance-based skills testing, a procedures examination, and neuropsych testing; on-going evaluation by an IPN certified addictionist; Board approval to engage in clinical nursing upon demonstration of competence via the stated testing; and monitoring in clinical practice for a minimum of five years, and thereafter until discontinuance is approved by the Board. The University of Florida has a program that would provide some of the testing required by the policy, including a neuropsychology testing that evaluates such areas as stability, judgment, concentration, and decision-making. In fact, IPN worked with the university to set up an individual plan for Petitioner. The program includes a simulated laboratory, examination, neuropsych testing, and provides feedback regarding remediation. Regardless of her chemical dependency, Petitioner has only practiced clinical nursing for 27 months since she was licensed in 1977, all prior to 1983. The field of nursing has been revolutionized since 1983. Nursing has new practice settings, new technologies, new drugs, new way of treating diseases, and new roles for the professional nurse. Petitioner needs extensive remedial education to reenter clinical nursing. Petitioner's continuing education over the last 10 years might keep her up to date on theory, but clinical remediation is necessary for clinical practice, because it is clinical skills that degrade fastest. Good clinical judgment cannot be learned without clinical training. Evaluating other nurses through facility surveys does not substitute for hands-on clinical experience. Therefore, it is reasonable that Petitioner comply with this requirement. In Petitioner's case, upon approval of the new IPN policy, the Board agreed to allow Petitioner to return to clinical nursing if she met the condition of the policy, and after she demonstrated six months of compliance with IPN requirements because of her previous history of noncompliance. The Board even agreed to consider termination of monitoring all together if Petitioner did well for five years in clinical practice. Petitioner declined the Board's conditions. In 1997 Petitioner filed another request for reinstatement of her license. By its Order on Petition for Reinstatement No. DOH 97-0450, filed December 23, 1997, the Board denied Petitioner's request for reinstatement. Petitioner was notified that her license would expire on July 31, 1998, unless she submitted the appropriate fees. Petitioner admitted that she received the renewal notice. Petitioner also admitted that she has not paid her license fees in over two years and has not paid them to date. Petitioner knew or should have known that she was obligated to renew her license while it was on suspension. She has done so in the past. The Board has notified licensees through its official newsletter that suspended licenses are subject to being renewed. Since Petitioner has been at the same address of record for all relevant times, it must be presumed that she received the newsletter sent to her. The staff of the Board of Nursing office is aware that suspended licenses are subject to renewal. The procedure is clearly spelled out for staff members handling general calls from the public. Petitioner testified that she called the Board of Nursing office and was told she did not have to renew her license if it was suspended. However, she was unable to identify the person who made such statement, or when her call was made. Petitioner's reliance on the caller's advice was not reasonable since she is well aware of the requirements for renewing her license and has done so in the past. Petitioner has failed and refuses to enter into and participate in IPN. Participation in IPN is a condition of the Final Orders of the Board of reinstatement of her license. Petitioner has failed to comply with the Final Order No. AHCA 96-00405 as required by Section 464.018(3), Florida Statutes, and her license is currently suspended. The conditions placed on her by the Board were reasonable. It is up to Petitioner to comply with those conditions. Moreover, during the pendency of this action Petitioner's license became delinquent. The delinquency lasted for more than two years. By operation of law, Petitioner's license was nullified. Therefore, there is no license on which the Board may take action.

Recommendation Based upon the findings of fact and conclusions of law, it is RECOMMENDED: That the application of Rebecca B. McCall for reinstatement of her license as a registered nurse be denied and this action be dismissed as moot since Petitioner's license has expired. DONE AND ENTERED this 24th day of October, 2000, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER 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 24th day of October, 2000.

Florida Laws (4) 120.57464.013464.014464.018
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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) 893.04893.07
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs STEPHEN E. NADEAU, M.D., 06-003863PL (2006)
Division of Administrative Hearings, Florida Filed:Gainesville, Florida Oct. 06, 2006 Number: 06-003863PL Latest Update: Dec. 25, 2024
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BOARD OF PHARMACY vs. BEN COHN, 82-002161 (1982)
Division of Administrative Hearings, Florida Number: 82-002161 Latest Update: Sep. 09, 1987

Findings Of Fact Respondent, Ben Cohn (Cohn), was at all times material hereto a licensed pharmacist in the State or Florida, having been issued license number 0009536. At all relevant times, Cohn was employed as a pharmacist at Don's Discount Drugs in South Miami, Florida. 1/ In or about October, 1981, Don's Discount Drugs was targeted by the Department of Professional Regulation and the Drug Enforcement Administration for a drug diversion audit of all Schedule II prescription drugs. The impetus for the audit was the quantity of methaqualone tablets, a Schedule II prescription drug, that were being dispensed at the store. The audit revealed no improprieties in the control or accountability of Schedule II prescription drugs at Don's Discount Drugs, but did reveal that during the period from August 4, 1981, through January 6, 1982, Don's Discount Drugs had dispensed 202,404 methaqualone 300 mg. tablets on 4,695 prescriptions. 2/ Of theses Cohn dispensed 118,130 methaqualone tablets on 2,724 prescriptions. The vast majority of these prescriptions were written for 45 tablets. The physicians who wrote the prescriptions which Cohn filled were largely employed by "stress clinics". These clinics actively advertised and solicited patients suffering from stress, and frequently prescribed methaqualone. There is, however, no competent proof that these clinics operated illegally, or that the physicians who wrote the prescriptions at issue in this case failed to do so in the good faith practice of their profession. During the time in question, it was legal in the State of Florida to prescribe and to dispense methaqualone. However, of the approximately 400 community pharmacies in Dade County only 10 would fill methaqualone prescriptions. Cohn knew he was dispensing a controversial drug with a high potential for abuse. Consequently, in filling each of the methaqualone prescriptions in question, as with all Schedule II drug prescriptions, Cohn followed a rigid procedure. As to each prescription, he verified that the person presenting the prescription was the person to whom the prescription was written by requiring a driver's license or others photo identification. Cohn then contacted the United States Department of Justice Drug Enforcement Administration to verify that the prescriber had a current DEA number. Cohn then verified with the prescriber that the prescription had been written for that patient and verified the number of tablets reflected on the prescription. Lastly, Cohn placed that patient's name and address on an index card together with the name of the doctor and the date of the prescription. These cards were maintained in a special file for reference in filling prescriptions to prevent dispensing any Schedule II drugs to the same person as a result of multiple prescriptions issued in too short a time period. All of the prescriptions in question were written by prescribers who were duly licensed by the Florida Board of Medical Examiners. None of the prescriptions in question was written or filled for an excessive number of methaqualone written tablets. 3/ Further, the parties have stipulated that Cohn complied with each of the conditions prescribed by Subsections (a)-(g), Section 893.04(1), Florida Statutes. Notwithstanding the fact that Petitioner offered no proof that any prescription filled by Cohn was not issued by a physician in the good faith practice of his profession, or was otherwise counterindicated, it suggests that Cohn did not act in good faith and in the course of professional practice when he filled the prescriptions. Factors which Petitioner deems important to such conclusion are: (1) the large number of prescriptions issued for the same quantity of drug, (2) the limited number of prescribers, (3) that most prescribers worked at "stress clinics", (4) the sudden influx of patients 18-30 years of age to fill prescriptions, (5) the precounting and prepackaging of methaqualone at the store, (6) the "general tone" of the community in regard to the abuse factor of methaqualone, (7) Cohn's failure to ascertain whether the drug was "for the benefit and welfare" of the patient, and (8) that many of the prescribing physicians maintained their offices outside the general neighborhood of the store. Petitioner's proof was not, however compelling. While the dispensing of 202,404 methaqualone tablets at Don's Discount Drugs between August 4, 1981, and January 6, 1982, appears facially to be a large quantity, Petitioner offered no proof to demonstrate its significance. No evidence was presented comparing the total number of methaqualone prescriptions filled at Don's Discount Drugs to the total number of methaqualone prescriptions filled in Dade County at the time. No evidence was presented comparing the number of methaqualone prescriptions filled at Don's Discount Drugs to the total number of prescriptions filled at that pharmacy. No evidence was presented concerning the statistical significance, if any, of the quantities of methaqualone tablets dispensed at Don's Discount Drugs. In sum, the dispensing of 202,404 methaqualone tablets at Don's Discount Drugs between August 4, 1981, and January 6, 1982, which represents an average of 35 prescriptions filled each day, was not demonstrated to be disproportionate to the legitimate needs of the population of Dade County. While many of the prescribers did maintain their offices outside the pharmacy's neighborhood, and a large number of methaqualone tablets dispensed at Don's Discount Drugs, it is significant that only 10 of 400 community pharmacies in Dade County would fill such prescriptions. Under such circumstances, it would not be unusual for such physicians' patients to travel to fill their prescriptions. Neither would it be unusual to find a large number of prescriptions being filled at the limited number of pharmacies willing to fill them. While Cohn did not ascertain whether the prescriptions were written "for the benefit and welfare" of the patient, or otherwise seek to second guess the attending physician by inquiring about the circumstances or diagnosis that prompted the prescription, he did confirm that the physician was properly licensed and that the physician had issued the prescription to the patient who presented it. The Department offered no credible proof that any physician misappropriately prescribed any drugs in this case. Accordingly, the presumption is that the physicians who wrote the subject prescriptions acted lawfully, and in the good faith practice of their profession. See: Atlantic Coast Line R. Co. v. Mack, 57 So.2d 447 (Fla. 1952). Under such circumstances, it cannot be concluded that Cohn failed to act in good faith and in the course of professional practice when he filled such prescriptions. The remaining factors cited by Petitioner are equally unpersuasive. The fact that the prescriptions were written by a limited number of physicians, most of whom were employed by "stress clinics", was not compelling because there was no showing that such physicians operated improperly. The fact that the store experienced a sudden influx of patients 18-30 years of age was not shown to be pertinent since there was no proof that the prescribing of methaqualone to such age group was counterindicated 4/ The fact that Don's Discount Drugs precounted and prepackaged methaqualone tablets demonstrated only that they anticipated a demand for the product; not any impropriety. Cohn's knowledge of the abuse potential for methaqualone and the procedures he employed to avert such abuse, was addressed in paragraph 6, supra. In rejecting petitioner's contention that Cohn failed to act in good faith and in the course of professional practice, I do not suggest that the factors advanced by Petitioner are not necessarily pertinent to the inquiry. Rather, I conclude that in this case such proof was not persuasive because there was no competent proof that any physician misprescribed or acted other than in the good faith practice of his profession. Such being the proof, it cannot be concluded that Cohn violated a community standard by filling a lawful and proper prescription. Cohn was first licensed as a practicing pharmacist in the State of New York in 1945, and has been practicing in the State of Florida since 1961. He has never been disciplined and has never had an administrative complaint, other than the instant complaint, filed against him regarding his practice of pharmacy.

Recommendation Based on the foregoing Finding of Fact and Conclusions of Law, it is RECOMMENDED: That a Final Order be entered DISMISSING the Administrative Complaint. DONE AND ORDERED this 9th day of September, 1987, in Tallahassee, Florida. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of September, 1987.

Florida Laws (3) 120.68465.016893.04
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs JOHN NKOLO MUBANG, M.D., 18-000606PL (2018)
Division of Administrative Hearings, Florida Filed:Tampa, Florida Feb. 05, 2018 Number: 18-000606PL Latest Update: Nov. 04, 2019

The Issue The issues to be decided are whether Respondent violated portions of chapter 458, Florida Statutes, as alleged in the Administrative Complaints; and, if so, what penalty should be imposed.

Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to this matter, Dr. Mubang was a licensed physician within the State of Florida, having been issued license number ME55171. Respondent’s address of record is 741 Martin Luther King Boulevard West, Seffner, Florida 33584. Since at least March 17, 2010, Dr. Mubang’s practice at 741 Martin Luther King Boulevard has been registered as a pain management clinic with Petitioner. Dr. Mubang is board-certified in geriatric medicine and ambulatory medicine. Dr. Mubang immigrated to the United States from Cameroon, West Africa, to obtain his college education at State University of New York-Buffalo (“SUNY-Buffalo”). Dr. Mubang received a bachelor of arts degree in biology from SUNY-Buffalo. Dr. Mubang attended medical school at Southwestern University School of Medicine in the Philippines. Upon completion of his medical education, Dr. Mubang attended the Medical College of Pennsylvania for clinical rotations. He performed his residency at State University of New York-Brooklyn and Hahnemann University. Dr. Mubang’s license was first issued June 14, 1989, and is valid through January 31, 2020. His license has not been the subject of prior discipline. Dr. Mubang has maintained his Drug Enforcement Agency (“DEA”) Certificate of Registration without revocation, suspension, or other sanction. He has additionally qualified for, and obtained, a separate DEA Certificate of Registration to dispense Suboxone and buprenorphine. This secondary DEA Certificate of Registration requires training in addiction medicine. Dr. Mubang has continuously practiced as the primary care physician for many of his patients. He began his practice in Florida with CIGNA Health Group in one of its managed care clinics at University Mall in Tampa. When CIGNA closed its clinics, Dr. Mubang became employed by Correctional Medical Services (“CMS”), initially at Lake Correctional Facility, and then as the medical director for the Hillsborough County Sheriff’s Office. During his tenure with the Hillsborough County Sheriff’s Office, Dr. Mubang was recognized as the “Medical Director of the Year” for CMS in 1998. After leaving the Hillsborough County Sheriff’s Office, Dr. Mubang joined a practice with Dr. Encarnacion in Seffner, Florida. When Dr. Encarnacion retired, Dr. Mubang acquired the practice. In May 2009, Dr. Mubang received from the Board of Medicine and the Department of Health a publication entitled, “responsible opioid prescribing.” Dr. Mubang learned through his participation in various continuing medical education seminars about certain forms recommended for the treatment of patients suffering from chronic pain. He did not use electronic medical records prior to the dates of treatment charged in these consolidated Administrative Complaints. While in private practice, Dr. Mubang continued to treat patients committed to the State of Florida Juvenile Assessment Centers in Pasco, Pinellas, Sarasota, and Manatee counties. Dr. Mubang’s practice was licensed as a pain management clinic in 2010, despite his having limited formal training or education in pain management. Since initial licensure, his pain management clinic has remained continuously in operation, and has consistently passed all inspections. Pain Management Clinics are subject to annual inspections by DOH pursuant to section 458.3265(4)(a). Dr. Mubang’s Pain Management Clinic has never failed an inspection. DOH Investigator Victor Troupe of the Investigative Services Unit performed inspections of Dr. Mubang’s clinic. The clinic passed inspection. Dr. Mubang’s charged treatment of Patients A.M., B.B., C.C., W.B., and M.H., as alleged in the Administrative Complaint, occurred prior to October 17, 2010, the effective date of revised rule 64B8-9.013. Both parties presented expert witnesses board-certified in pain management to testify as to the standard of care required in this matter. Dr. Robert Guskiewicz testified as a medical expert for Petitioner. Dr. Guskiewicz is board-certified by the American Board of Anesthesiology in anesthesiology with a subspecialty in pain medicine. Dr. Guskiewicz practices as part of a large multispecialty practice in Gainesville, Florida, called Southeast Integrated Medical (“SIMED”). SIMED’s practice areas include neurology, neurosurgery, rheumatology, gynecology, psychology, urology, physiatry, allergy, family practice, and internal medicine. Dr. Guskiewicz is not now, and never has been, a primary care physician. About 40 percent of Dr. Guskiewicz’s practice is performing injections or interventions on patients. Most of the balance is patients on medication management seeking to achieve better functionality. Dr. Guskiewicz defines the standard of care as “what a prudent physician would do with a particular patient in a particular situation at that particular time.” In his practice, Dr. Guskiewicz prescribes 30 mg of oxycodone. Oxycodone is an effective pain medication. According to him, there is no maximum recommended dose for 30 mg of oxycodone. For the purposes of his expert testimony, Dr. Guskiewicz has no knowledge or information regarding Dr. Mubang or his practice. He does not know how big the clinic is where Dr. Mubang practices, who owns it, how many patients are seen each day, how many employees work there, or the types of patients treated there. Dr. Guskiewicz was paid an hourly fee for his expert testimony and preparation for deposition in this matter. Dr. Guskiewicz testified that he did a page-by-page review of the medical records he initially reviewed and those provided for his deposition in lieu of live testimony. Dr. Guskiewicz testified that the records were identical for Patients A.M., B.B., W.B., and M.H., but that the Bates numbers for the records for Patients C.C. and B.D. were not in sync. For Patient B.B., it was apparent at the hearing that Dr. Guskiewicz was in possession of the requisite records, which Respondent argued, had not been reviewed. For Patient M.H., Dr. Mubang argued that Joint Exhibit 6, covering records of treatment from 2010-2012, was not reviewed by Dr. Guskiewicz. Dr. Guskiewicz testified that the records for Patient M.H. were identical. In any event, the records subject to Respondent’s objection concern treatment after the treatment dates at issue in the Administrative Complaint. Only the records concerning the allegations contained in the Administrative Complaints will be considered for purposes of this Recommended Order. Dr. Mubang also raised the issue that Dr. Guskiewicz was not a similarly situated practitioner to Respondent. Dr. Mubang self-identified as practicing in pain management, and he owned and operated a clinic that was registered as a pain management clinic with DOH. Each patient treated by Dr. Mubang signed an Attestation for Pain Management, along with an Agreement for Treatment with Controlled Substances Therapy for Pain. Dr. Mubang acknowledged that if he gave a patient a pain management agreement, he was providing pain management to that patient. If a health care provider is providing evaluation, treatment, or diagnosis for a condition that is not within his or her specialty, a specialist trained in the evaluation, treatment, or diagnosis for that condition shall be considered a similar health care provider, pursuant to section 766.102(8), Florida Statutes. Because Respondent’s care at issue in this case is pain management, which is not specifically within his specialty, Dr. Guskiewicz is considered a similarly situated practitioner to Respondent. Petitioner did not provide Dr. Guskiewicz with any deposition testimony in this action until after his deposition in lieu of live testimony on October 9, 2018. Consequently, the depositions were not considered at the time Dr. Guskiewicz prepared his reports in this action. Dr. Guskiewicz never interviewed any of the patients at issue in this matter; never conducted any physical examination of the patients; and does not know where any of these patients are today. Further, he does not know what their current condition is; whether any of the patients are still receiving treatment for chronic pain; and whether any of the patients are still receiving opioid pain medications for the treatment of chronic pain. During the time periods relevant to these consolidated actions, Florida did not have a prescription drug monitoring database or E-FORCSE. At the time Dr. Guskiewicz authored his November 29, 2011, report, there was not a prescription drug monitoring database in Florida to permit practitioners to verify a patient’s representations about the medications they were taking and who had prescribed them. Dr. Guskiewicz is not a primary care physician, and has never been called upon to cover for a primary care physician who is treating a patient and has an ongoing relationship with that patient. Dr. Guskiewicz agrees that physicians in Florida have an obligation to consider their patients’ subjective complaints of pain and to treat them. Dr. Guskiewicz defines pain management as “treating patients who have chronic pain and provide different modalities of care to increase the functionality and well-being within that patient.” The goal of pain management is to optimize the patient’s functionality, lifestyle, and well-being within his or her family and community. Dr. Guskiewicz acknowledged that a patient coming to him for medical management of his or her pain is looking for an increase in function so he or she can get back to work and participate in normal activities of daily living. Dr. Guskiewicz defines intractable pain as “pain that perpetuates itself no matter what modalities are tried and will always be there. It’s now thought of being a more centralized pain that is basically within the brain itself.” Dr. Thomas Simopoulos testified as a medical expert for Respondent. Dr. Simopoulos is board-certified by the American Board of Anesthesiology in anesthesiology with a subspecialty in pain medicine. Dr. Simopoulos testifies as an expert for the defense more than 90 percent of the time. In the last five years, Respondent’s counsel has paid Dr. Simopoulos $30,000 to $50,000 in expert witness fees. Dr. Simopoulos lives in and practices medicine in Massachusetts. Dr. Simopoulos is not licensed to practice medicine in any other state; and he has never practiced medicine in the State of Florida. Dr. Simopoulos testified that the standard of care at the time material to this case was more regional than national. Dr. Simopoulos educated himself about the regional standard of care in Florida through conversations with his students and through hearing from people at national meetings. Dr. Simopoulos testified that patients have the right to reject a surgical recommendation: “Patients who are younger, in their more productive years, may not want to seek out surgery as a solution, particularly of the spine because it usually means that they’re at risk for having multiple surgeries. So and that even continues today, we try to manage younger folks with more conservative measure [sic], including medications to try to avoid surgery, because we know where that trajectory is going to go.” Dr. Simopoulos admitted that there were no studies at the time material to this case that revealed the exact nature and course of practice in the State of Florida. While Dr. Simopoulos is credited as an expert in anesthesiology and pain management, his reliance on the second- hand accounts from students and conferences he attended to form his opinions about the regional standard of care in Florida, are not as persuasive as the accounts of Dr. Guskiewicz, a physician practicing in the area of anesthesiology and pain management in Florida. Accordingly, Dr. Guskiewicz’s testimony is entitled to greater weight in this proceeding. Dr. Simopoulos also opined that the standard of care can only be violated when a patient is harmed. DOH argued that his definition is inconsistent with the definition in Florida law as contained in section 766.102(1). DOH Investigator Victor Troupe served a subpoena on September 2, 2010, for patient records to include: A.M., B.B., C.C., M.H., and W.B. Investigator Troupe took possession of the original files on that date. He has no reason to believe those patient files had been altered in any way. Investigator Troupe had performed numerous annual inspections of Dr. Mubang’s clinic, and neither found any violations or issued any citations. Investigator Troupe never interviewed Patients A.M., B.B., C.C., M.H., W.B., or B.D. Further, Investigator Troupe has no knowledge or information regarding the present whereabouts of any of those individuals. Finally, he has no information about whether those patients are still receiving opioid analgesic pain medication, even though DOH has access to E-FORCSE for investigative purposes. Drug Definitions Oxycodone is commonly prescribed to treat pain. Roxicodone is a brand name for oxycodone. Oxycodone is a Schedule II controlled substance. Oxycodone will be used throughout this Order, even if the brand name Roxicodone was prescribed. All Schedule II controlled substances have a high potential for abuse and have currently accepted, but severely restricted, medical use in treatment in the United States. Abuse of Schedule II controlled substances may lead to severe psychological or physical dependence. § 893.03(2), Fla. Stat. Fentanyl is a very strong opioid that is prescribed to treat pain and is listed as a Schedule II controlled substance. § 893.03(2)(b), Fla. Stat. Hydromorphone is a Schedule II controlled substance that is commonly prescribed to treat pain. Hydromorphone is commonly prescribed under the brand name Dilaudid. § 893.03(2)(a), Fla. Stat. Methadone is a synthetic opioid prescribed to treat pain. Methadone is a Schedule II controlled substance. § 893.03(2)(b), Fla. Stat. Vicodin and Lortab are brand names for hydrocodone/APAP. Hydrocodone/APAP contains hydrocodone and acetaminophen and is prescribed to treat pain. Hydrocodone in the dosages found in Vicodin is a Schedule III controlled substance. § 893.03(3)(c)4., Fla. Stat. All Schedule III controlled substances have a potential for abuse less than the substances in Schedules I and II. Abuse of Schedule III controlled substances may lead to moderate or low physical dependence or high psychological dependence. § 893.03(3), Fla. Stat. Fiorinal with codeine is the brand name for a drug that contains butalbital and codeine and is commonly prescribed to treat migraine headaches. Butalbital is a Schedule III controlled substance. Codeine is commonly prescribed to treat pain. Codeine is a Schedule II controlled substance. § 893.03(3)(a) and (2)(a), Fla. Stat. Ultram is a brand name for tramadol, an opioid-class narcotic medication prescribed to treat pain. At the time of the events of this case, tramadol was not a controlled substance. Tramadol is currently a Schedule IV controlled substance. § 893.03(4)(b), Fla. Stat. (2018). All Schedule IV controlled substances have a low potential for abuse relative to the substances in Schedule III. Abuse of Schedule IV controlled substances may lead to limited physical or psychological dependence relative to the substances in Schedule III. § 893.03(4), Fla. Stat. Soma is the brand name for carisoprodol. Carisoprodol is a muscle relaxant commonly prescribed to treat muscular pain. Carisoprodol is a Schedule IV controlled substance. § 893.03(4), Fla. Stat. Adderall is the brand name for a drug that contains amphetamine. Adderall is commonly prescribed to treat attention deficit disorder (“ADD”). Adderall is a Schedule II controlled substance. § 893.03(2)(c), Fla. Stat. Xanax is the brand name for alprazolam. Klonopin is the brand name for clonazepam. Valium is the brand name for diazepam. All three drugs are benzodiazepine-class drugs prescribed to treat anxiety, and all three drugs are Schedule IV controlled substances. During the time Respondent treated the five patients, who are the subject of the DOH Case No. 2010-12384, Florida did not have a prescription drug monitoring database. Before E-FORCSE, practitioners had to rely upon a patient’s representation regarding his or her medication history and verify the information by calling identified pharmacies. This “trust but verify” policy was in place at Dr. Mubang’s practice. During the time of Dr. Mubang’s treatment of these patients, he received a letter from Ana M. Viamonte Ros, M.D., the surgeon general for the State of Florida, and Fred Bearison, M.D., the chairman of the Florida Board of Medicine, dated May 13, 2009. That letter enclosed a copy of Responsible Opioid Prescribing, A Physician’s Guide, written by Scott M. Fishman, M.D. The letter advised Dr. Mubang, and others similarly situated, that Dr. Fishman’s book “is a practical guide to Florida’s current standards for the use of controlled substances for the treatment of pain,” based upon the Federation of State Medical Board’s Model Rule, “so it is right on point for Florida practicing doctors.” The book also stated, at page 25: Although Medicare and other institutions have defined what constitutes a physical examination for purposes of coding and reimbursement, exactly what comprises an appropriate or acceptable physical examination for pain is not well-defined, largely because it will differ from case to case. Regulators who expect to see a physical examination as part of the evaluation that leads to appropriate pain care involving controlled substances assume that a basic, if not focused, examination is warranted. The exact components of the examination are left to the judgment of the clinician who is expected to have performed an examination proportionate to the diagnosis that justifies a treatment. Dr. Mubang testified at the hearing, “many point-of- care screens for ‘opiates’ do not reliably detect any opioid other than codeine and morphine, or may not report if levels are below a certain threshold. Therefore, they may give false negative results for semisynthetic and synthetic oil opioid analgesics.” Dr. Mubang received feedback from pharmacists and patients regarding limitations on prescribing imposed on distributors and pharmacies by the DEA, including during the fall of 2010. During the time Dr. Mubang treated the six patients subject to these consolidated administrative actions, there was no upper limit recommended or identified regarding the maximum dosage for opioid analgesics. New patients to Dr. Mubang’s practice have to fill out paperwork, including a patient history. Patients were also required to sign an opioid contract, which mandated patients to use only one pharmacy and required that the patient only obtain medication from Dr. Mubang. Dr. Mubang obtained authorizations for release of medical information to acquire records of prior treating physicians. His office consistently obtained prior records, including MRIs and other diagnostic studies. Dr. Mubang testified that he performed a physical examination of each patient on each office visit. The initial exam was broad, while follow-up examinations were focal. His physical examinations included a review of systems, from head to toe. He stated that each physical examination included a review of the patient’s neurological status and notes whether the patient is oriented to person, time, and place. Dr. Mubang’s practice was to observe patients in his waiting room, and watch each patient as they come to the exam room. This observation is intended to identify things like gait abnormalities, guarding, and posture. Pain patients in Dr. Mubang’s practice are required to complete a Brief Pain Inventory, which he reviews with each patient. Dr. Mubang also reviews past medications with each patient to determine whether the medication has been effective in relieving pain and increasing activities of daily living. He reviews with each patient potential side effects of medication and the risks and benefits of using those medications. Dr. Mubang prepares a progress note for each office visit with a patient. Additionally, he maintains copies of each prescription issued to a patient. The identified treatment plan for each of these six patients was to improve the patient’s functional abilities, to allow them to return to work, and to participate in relationships. Dr. Mubang periodically required patients to submit to a urine immunoassay. This is a presumptive screening test for illicit substances and some other controlled substances. As Dr. Fishman points out on page 61 in his book Responsible Opioid Prescribing, Dr. Mubang was aware that “point-of-care screens for opioids do not reliably detect any opiate other than codeine and morphine.” During the 2010 timeframe, a physician who ordered a urine drug screen was not required to do anything with the results. Further, the requirements of rule 64B8-9.013(3)(d) to monitor patient compliance were not mandatory until after October 17, 2010. Dr. Mubang is aware of the sedative effects of opioids taken with muscle relaxants like Soma. This combination of medication should be dispensed with caution, but if a patient has been taking it for a period of time with no problems, he believes the prescription is appropriate. Dr. Mubang’s approach to changing pain medication, as explored more fully in the following discussion of the six patients subject to this proceeding is consistent, but deserves close scrutiny. He testified that: If the vital signs are stable, you can do what you want, so long as it doesn't have consequences. If you see the visit after this, this patient did not come in with hypertension or they did not end up in the hospital or I was not called at 2:00 in the morning. So it tells you what you're doing is right. See? That's why we do these vital signs. The Patients Each of the patients in this cause completed a two-page questionnaire about his or her pain, titled “brief pain inventory,” during each visit after the initial visit. The pain inventory contained: an anatomical figure for the patient to mark painful areas, 12 questions with a one-to-ten scale for pain level and for activities of daily living, and spaces for the patient to describe the pain in writing. Dr. Mubang’s progress notes for each of the patients consisted of a printed form, containing a similar anatomical figure at the top of the page with most of the rest of the page containing a checklist for “assessment.” Patient A.M. From December 22, 2009, to October 20, 2010, Dr. Mubang provided pain management treatment to Patient A.M., a then 23-year-old female, for lower back pain related to a car accident that occurred several years earlier. Dr. Mubang had first begun treating Patient A.M. while covering for Dr. Luis Azan at Plant City Polyclinic, where he prescribed her 240 30 mg tablets of oxycodone and 120 10 mg tablets of methadone. Dr. Mubang noted that Patient A.M. had been a passenger in the back of the car and was wearing a seatbelt. He noted that Patient A.M. did not lose consciousness, and while she went to the emergency room, she did not have an in-patient stay. On her initial evaluation questionnaire, Patient A.M. reported trying four alternative treatment methods for her pain out of 18 possible treatment options on Dr. Mubang’s checklist form: chiropractic treatment (no relief); muscle injections (no relief); massage (no relief); and pain relievers (some relief). By her own report, Patient A.M. had not tried physical therapy, nerve blocks, or surgery. Patient A.M. had sequential MRI findings from November 7, 2007 (ordered by Dr. Murthy Ravipati), and March 23, 2010 (ordered by Dr. Mubang), which demonstrated a central focal disc protrusion (herniated nucleus pulposus) at L5-S1. On her first visit at his office, Dr. Mubang increased Patient A.M.’s oxycodone from 240 to 270 30 mg tablets per month. He failed to document a rationale for the 30-pill increase. Dr. Mubang’s medical records included Patient A.M.’s medical history and physical examination; diagnostic, therapeutic, and laboratory results; evaluations and consultations; objectives identified; risks and benefits of the treatment ordered; treatments and medications ordered and documented; and instructions and agreements regarding pain management. Dr. Mubang made referrals to consulting physicians, including Dr. Goldsmith (orthopedic) and physical therapy (Select Physical Therapy). From December 22, 2009, to August 27, 2010, Dr. Mubang prescribed 270 30 mg tablets of oxycodone in combination with 120 10 mg tablets of methadone to Patient A.M. monthly. In ten months, Patient A.M. received 3,870 pain pills from Dr. Mubang. In order to take the pain medication as prescribed, Patient A.M. would have to take 13 pain pills per day. By comparison, Dr. Mubang’s expert, Dr. Simopoulos, testified that in his practice the most 30 mg of oxycodone that he ever prescribed was six tablets per day, or 180-200 tablets per month. Petitioner’s expert, Dr. Guskiewicz, testified that in his practice the most 30 mg of oxycodone that he ever prescribed was five per day, or 150 tablets. In addition to the pain medication, Dr. Mubang prescribed 90 350 mg tablets of Soma to Patient A.M. per month. On August 2, 2010, Dr. Mubang ordered a urine drug screen for Patient A.M. The drug screen was positive for benzodiazepines and negative for methadone. If a patient tests negative for a prescribed medication, the physician should consider the possibility that the patient is not taking the drug and, instead, is diverting it. Given Patient A.M.’s negative test for methadone, Dr. Mubang should not have continued to prescribe methadone to her, or at least should have questioned her about her usage of the prescribed drug. Despite the aberrant test result, Dr. Mubang continued to prescribe potentially lethal doses of oxycodone, methadone, and Soma to Patient A.M. Further, from December 22, 2009, through August 27, 2010, Dr. Mubang did not perform nor did he document performing a complete and adequate physical examination or medical history to justify his prescribing of potentially lethal doses of methadone, oxycodone, and Soma to Patient A.M. From December 22, 2009, through August 27, 2010, Dr. Mubang did not diagnose Patient A.M. with intractable pain prior to prescribing potentially lethal doses of methadone, oxycodone, and Soma to Patient A.M. To meet the standard of care, Dr. Mubang should have immediately reduced the amount of medication that he prescribed to Patient A.M. Additionally, he should have tried to determine the root cause of Patient A.M.’s pain. Dr. Mubang should have followed up on his ordering of alternative treatment modalities, such as physical therapy, and if Patient A.M. refused to follow his instructions, he should have discharged Patient A.M. While Dr. Mubang’s records are at times difficult to read, some were legible enough for review by the two experts who offered opinions in this matter. On the whole, however, the medical records for Patient A.M. were inadequate (and some of them were actually illegible) to provide complete information to either Dr. Mubang or another reviewing physician or investigator. Patient B.B. From March 25, 2010, to August 23, 2010, Respondent provided pain management treatment to Patient B.B., a then 25- year-old female. Patient B.B. initially visited Dr. Mubang on March 25, 2010, with a history of cervical spinal fusion in 2003 following a motor vehicle accident. Dr. Mubang’s Initial Evaluation documented a thorough review of systems, including skin; HEENT (head, eyes, ears, nose, and throat); neurological; and musculoskeletal. Simultaneously, Dr. Mubang and the patient completed a Pain Questionnaire documenting the location and severity of Patient B.B.’s pain and other treatment modalities, which had been tried, but failed (surgery, braces, chiropractic, physical therapy, TENS, and massage). On her initial visit with Dr. Mubang, Patient B.B. reported having neck, shoulder, and upper back pain. Dr. Mubang noted on his initial range of motion assessment that Patient B.B. had no thoraco-lumbar spine pain. Patient B.B. never indicated on her brief pain inventories that she had pain radiating down the leg. Instead, she consistently marked pain in the neck, radiating down the right arm, and pain in the middle back. After the initial visit, Dr. Mubang recorded that Patient B.B. had lower back pain by noting “LBP & radiculopathy” with a line drawn down the leg of the anatomical figure. Dr. Mubang’s explanation for the discrepancy between his notation on the anatomical figure and Patient B.B.’s notation was that the patient was noting pain, but that he was noting tenderness. He did not explain the difference. As discussed below, this same inconsistency appears frequently in many of the patients’ records. Dr. Mubang’s offered explanation for the discrepancy between his records and the patient-generated records is not credible. From March 25, 2010, to August 23, 2010, Dr. Mubang prescribed 240 30 mg tablets of oxycodone in combination with 60 2 mg tablets of Xanax to Patient B.B. monthly. From March 25, 2010, to May 20, 2010, Dr. Mubang also prescribed 120 350 mg tablets of Soma to Patient B.B., in addition to the oxycodone and Xanax each month. To justify the amount of Xanax he prescribed to Patient B.B., Dr. Mubang relied on an anxiety checklist questionnaire completed by Patient B.B. In his practice, if a patient marked five to six of the criteria on his anxiety checklist, Dr. Mubang would prescribe the patient Xanax. For Patient B.B., on three of his five progress notes, Dr. Mubang checked the box for anxiety. Other than that, there is no annotation or documentation by Dr. Mubang concerning Patient B.B.’s anxiety. From March 25, 2010, through August 23, 2010, based on Patient B.B.’s history and physical findings, Dr. Mubang prescribed potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. in excessive quantities and without sufficient justification. From March 25, 2010, through August 23, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing of potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. From March 25, 2010, through August 23, 2010, Dr. Mubang failed to diagnose Patient B.B. with an anxiety disorder, which would have supported his prescribing of Xanax to Patient B.B. From March 25, 2010, through August 23, 2010, Dr. Mubang did not diagnose Patient B.B. with intractable pain prior to prescribing potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. To meet the standard of care, Dr. Mubang should have done more to treat Patient B.B.’s underlying source of pain through referrals for physical therapy or orthopedics. Depending on the particular findings, he should have tried intervention care to relieve Patient B.B.’s pain instead of relying solely on medication management, particularly, excessive amounts of oxycodone. Patient B.B., as a relatively young patient, would have benefited from more aggressive physical therapy, massage therapy, and other treatment modalities to keep her off of addictive pain medication as much as possible. Dr. Mubang attempted, in part, to justify his excessive amounts of medications, based upon The Super Saver pharmacy profile for Patient B.B., which confirms that this patient was receiving the same quantities and combination of medications from the prior physician, Ibem R. Borges, M.D. He also cites rule 64B8-9.013 (2003) to support the heavy prescribing of medications, which indicates the Board of Medicine will not judge the validity of prescribing, “based upon the quantity and chronicity,” and that a “physician’s conduct will be evaluated to a great extent by treatment outcome.” He argues that Petitioner failed to introduce any evidence to establish Patient B.B. suffered any adverse effect from Dr. Mubang’s treatment. Patient C.C. From April 29, 2010, to May 28, 2012, Dr. Mubang provided pain management treatment to Patient C.C., a then 32-year-old female. At her initial evaluation, Patient C.C. reported having lower back pain and left knee pain. On her subsequent brief pain inventories, Patient C.C. consistently marked pain at the middle of the lower back and pain at the left knee. Almost identical to Patient B.B., Dr. Mubang’s progress notes for Patient C.C. note “LBP & radiculopathy” with a line drawn down the leg of an anatomical figure indicating pain radiating down the leg. Contained in Respondent’s records were notes from two prior treating providers, Drs. David Herson and Marc Weinstein. On a note dated February 27, 2007, Dr. Herson noted that Patient C.C.’s cervical and lumbar range of motion was within normal limits, and he noted no tenderness to palpation of the lumbar spine. Dr. Herson recommended epidural injections to Patient C.C. for the left knee pain. Dr. Herson prescribed Patient C.C. 30 tablets of Ultram for her pain. On a note dated March 1, 2007, Dr. Weinstein noted that “MRI scans of her cervical and lumbar spine and left knee were performed and show no significant abnormalities that would require surgery.” From April 29, 2010, to August 19, 2010, Dr. Mubang prescribed 290 30 mg tablets of oxycodone in combination with 180 10 mg tablets of methadone to Patient C.C. monthly. In a period of four months, Patient C.C. received 2,350 pain pills from Dr. Mubang, which equates to a daily prescription of 15.5 pills. In addition to addictive pain medication, Dr. Mubang also prescribed 60 2 mg tablets of Xanax to Patient C.C. per month. Opioids and benzodiazepines in combination increase the risk of respiratory depression, which can be fatal. On April 29, 2010, and May 27, 2010, Dr. Mubang added 90 350 mg tablets of Soma to the potentially lethal cocktail of medications he prescribed to Patient C.C. Dr. Mubang failed to document his rationale for starting and stopping Soma. On April 29, 2010, as part of her initial evaluation with Dr. Mubang, Patient C.C. reported to him that her current medications were oxycodone, methadone, Xanax, and Soma. On April 29, 2010, Dr. Mubang ordered a urine drug screen for Patient C.C. The drug screen was positive for opiates, oxycodone, and benzodiazepines, but was negative for methadone. Opiates and opioids are discernibly different categories of drugs. Opiates are morphine derivatives. Opioids are synthetic opiates. No medications Patient C.C. reported taking were opiates. The standard of care required Dr. Mubang to inquire as to the reasons behind the aberrant drug test result and adjust Patient C.C.’s medications accordingly. In his 2012 deposition, Dr. Mubang speculated that he may have consulted Patient C.C. about the drug test and that maybe she ran out of medication. He could not tell from his records if he discussed the results with Patient C.C. or the reason for the aberrant test result because his records lacked any such information. At the final hearing in this matter, Dr. Mubang raised for the first time the defense that the urine drug screen he used at that time was incapable of testing for methadone. He also argued that if a patient is taking oxycodone and methadone together, then either one, both, or neither may show up positive on a urine drug screen due to “tolerance” and methadone’s interaction with oxycodone and with the NMDA (the amino acid neuro receptor that increases the tolerance of oxycodone by interacting with methadone). This was a clear misunderstanding by Dr. Mubang of his expert’s testimony regarding the use of methadone in pain management. Dr. Mubang testified many times at hearing that methadone has a tolerance effect on oxycodone, which causes a physician to increase the dose of oxycodone. Respondent’s testimony was incongruent with the description given by his expert witness. Dr. Simopoulos explained that methadone can antagonize NMDA receptors, which can help some patients who have a tolerance to oxycodone. However, Dr. Simopoulos’s testimony regarding NMDA did not relate to the ability to detect methadone in a urine drug screen. Despite the negative test result for methadone, during the same visit, Dr. Mubang prescribed 180 10 mg tablets of methadone to Patient C.C. No questions of whether Patient C.C. may have diverted her methadone or notations of such were in the doctor’s notes. Dr. Mubang failed to order a second urine drug screen for Patient C.C. until ten months later on February 2, 2011. The second test was also negative for the prescribed medication methadone. From April 29, 2010, through August 19, 2010, based on Patient C.C.’s presentation, Dr. Mubang prescribed potentially lethal doses of oxycodone, methadone, Xanax, and Soma to Patient C.C. inappropriately, in excessive quantities, and without justification. From April 29, 2010, through August 19, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing potentially lethal doses of oxycodone, methadone, Xanax, and Soma to Patient C.C. Dr. Mubang did not diagnose Patient C.C. with intractable pain prior to prescribing to the patient the potentially lethal doses of oxycodone, methadone, Xanax, and Soma. To meet the standard of care, Dr. Mubang should not have prescribed such large amounts of pain medication to Patient C.C., a patient who did not have a significant pathology for pain. Instead, he should have pursued other treatment modalities, such as injections and physical therapy. Patient W.B. From December 13, 2008, to February 18, 2011, Dr. Mubang provided pain management treatment to Patient W.B., a then 52-year-old male. On or about April 20, 2008, prior to visiting Dr. Mubang, Patient W.B. presented to the emergency room at Sarasota Memorial Hospital after being hit by a “slow moving vehicle,” while riding his bicycle. The emergency room physician diagnosed Patient W.B. with a bruise of the left knee and left hip and prescribed an unknown quantity of 7.5 mg Lortab to Patient W.B. Patient W.B. then visited Physician’s Group, LLC, in Sarasota for follow-up care on April 20, May 28, November 11, and December 2, 2008. On May 28, 2008, Patient W.B. reported to a provider at Physician’s Group, LLC, that he had taken Dilaudid from a friend. On November 11, 2008, Patient W.B. saw Dr. Frederic Sonstein. Dr. Sonstein noted that Patient W.B. missed a scheduled appointment because he was incarcerated. While incarcerated, Patient W.B. was treated with Flexeril and Ultram. Dr. Sonstein recommended referral to a pain management specialist and prescribed Vicodin for pain control. A November 24, 2008, MRI report of Patient W.B.’s lumbar spine was unremarkable. On December 13, 2008, Patient W.B. came to Dr. Mubang and reported having pain in his neck and shoulders, with pain radiating down both arms. In contrast to Patient W.B.’s report, on his initial range of motion evaluation, Dr. Mubang did not document any findings under cervical spine. Instead, he noted lumbar spine pain with radiculopathy. On his initial evaluation questionnaire, Patient W.B. reported only having tried one alternative treatment method for his pain, “braces or cast.” By his own report, Patient W.B. had not tried any of the other alternative treatment options on Dr. Mubang’s checklist form, such as physical therapy, chiropractic, muscle injections, or surgery. Despite the minimal objective findings in Patient W.B.’s history, Dr. Mubang began to prescribe escalating amounts of oxycodone to Patient W.B. On December 13, 2008, Dr. Mubang prescribed 120 30 mg tablets of oxycodone to Patient W.B. Then, he increased the amount of oxycodone he prescribed to Patient W.B. over the following monthly visits as follows: 150, 180, 210, 210, 240, 240, and ultimately settling at 270 30 mg tablets of oxycodone per month. From December 13, 2008, to August 24, 2010, Dr. Mubang prescribed Patient W.B. 4,050 30 mg tablets of oxycodone. On July 11, 2009, in addition to oxycodone and Soma, Dr. Mubang added Xanax and Fiorinal with codeine to Patient W.B.’s monthly prescription regimen. Like with Patient B.B., Dr. Mubang prescribed Xanax to Patient W.B. based on Patient W.B.’s answers to his checklist anxiety questionnaire. On July 11, 2009, Dr. Mubang saw Patient W.B. and renewed his medication. He scheduled Patient W.B. to return on August 9, 2009; however, Patient W.B. missed the appointment. Patient W.B. next visited Dr. Mubang two months later, on October 13, 2009. Dr. Mubang failed to document the reason for Patient W.B.’s three-month absence. He failed to document if Patient W.B. continued to receive pain medication from another source. He did not note whether Patient W.B. experienced withdrawal symptoms without his oxycodone for two months or how Patient W.B. managed his pain without oxycodone for two months. Dr. Mubang admitted during the hearing that, “[i]t is important to me to know why he misses visits. And you're right. Your point is well-taken.” Dr. Mubang’s own controlled substance agreement, which was executed by Patient W.B., explicitly stated that renewals are contingent on keeping scheduled appointments. Despite the unexplained absence, on October 13, 2009, he renewed Patient W.B.’s prescriptions for 270 tablets oxycodone, 30 tablets Soma, 60 tablets Xanax, and 90 tablets of Fiorinal with codeine. Dr. Mubang should not have restarted Patient W.B. at the same high dosage of oxycodone that he had previously prescribed, as it was potentially fatal. On November 10, 2009, Dr. Mubang ordered a urine drug screen for Patient W.B. The drug screen was positive for cocaine and hydromorphone. The drug screen was negative for the prescribed medications Soma (carisoprodol) and Xanax (alprazolam). Based upon the November 10, 2009, drug screen result, the standard of care required Dr. Mubang to refer Patient W.B. to a drug treatment center. When questioned about the positive cocaine result, Dr. Mubang’s expert, Dr. Simopoulos, testified, “That’s the part where this patient has a substance abuse disorder, obviously.” Dr. Simopoulos opined that, “if you are going to continue prescribing in this case, because the patient has duel diagnoses, you would want the input of a psychiatrist for this case.” Patient W.B. next visited Dr. Mubang approximately three months later on February 9, 2010. Again, Dr. Mubang failed to document the reason for the absence. At the February 9, 2010, visit, Dr. Mubang ordered a urine drug screen for Patient W.B., which returned completely negative results. After a multi-month absence and with a completely negative urine drug screen, Patient W.B. would have been opioid negative. In his 2012 deposition, Dr. Mubang theorized that the completely negative result may have been because Patient W.B. drove himself to his appointment and Dr. Mubang instructed his patients not to drive while on medication. This made little sense. Despite the completely negative result and unexplained absence, Respondent prescribed Patient W.B. 270 tablets of oxycodone, 30 tablets of Soma, 60 tablets of Xanax, and 90 tablets of Fiorinal with codeine. Again, Dr. Mubang should not have restarted Patient W.B. at the same high dosage of oxycodone that he had previously prescribed, as it was potentially fatal. Despite prescribing 270 tablets of oxycodone per month to Patient W.B., or nine pills per day, Dr. Mubang testified at hearing that, “[i]f I give them what they call ‘breakthrough medications,’ like oxycodone, all these, they'll tell you some days they take it, some days they don't take it.” Dr. Mubang was aware that Patient W.B. did not require nine oxycodone tablets per day and that the amount of oxycodone he prescribed to Patient W.B. was not justified. The foregoing pattern of unexplained absence and completely negative urine drug screen result, followed by Dr. Mubang renewing prescriptions, was repeated in November 2010. From December 13, 2008, through November 10, 2010, Dr. Mubang prescribed potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. inappropriately, in excessive quantities, and without justification. From December 13, 2008, through November 10, 2010, Dr. Mubang neither performed nor did he document performing a complete and adequate physical examination or medical history to justify his prescribing of the potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. From December 13, 2008, through August 24, 2010, Respondent did not diagnose Patient W.B. with intractable pain prior to prescribing potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. To meet the standard of care, Dr. Mubang should have discontinued prescribing the amount of medication that he prescribed to Patient W.B. based on the minimal findings in Patient W.B.’s history and the minimal changes on examination. In addition, Dr. Mubang should have referred Patient W.B. to a drug treatment center. Patient M.H. From January 10, 2005, to May 29, 2012, Dr. Mubang provided pain management treatment to Patient M.H., who first visited him as a 29-year-old female, suffering lower back pain. Prior to seeing Dr. Mubang, on March 24, 2004, Patient M.H. visited Dr. Edward Jacobson. Dr. Jacobson noted that Patient M.H. had been in a car accident on February 21, 2004, and that Patient M.H. was complaining of headaches. He prescribed 15 tablets of Vicodin to her. On January 10, 2005, Patient M.H.’s first visit with Dr. Mubang, he prescribed her 60 tablets of Vicodin. On January 21, 2005, Dr. Mubang added clonazepam and Adderall to Patient M.H.’s medication regimen. Dr. Mubang’s note for the January 21, 2005, visit does not make any mention of Patient M.H. suffering from an anxiety disorder or ADD that would justify his use of clonazepam or Adderall, save for a simple “ADD” noted in the assessment/plan portion of the form. Dr. Mubang should have referred Patient M.H. to a psychiatrist for diagnostic confirmation of ADD before automatically prescribing (or refilling) the Adderall prescription. From June 15, 2005, to March 7, 2007, Dr. Mubang prescribed Valium in combination with clonazepam to Patient M.H. monthly. Then on March 23, 2009, he discontinued clonazepam and started Patient M.H. on 90 2 mg tablets of Xanax. Dr. Mubang neglected to document a justification for prescribing Patient M.H. benzodiazepine-class drugs, or for prescribing her a combination of two different benzodiazepine- class drugs, or for the changes he made to the benzodiazepines he prescribed. On January 6, 2009, Patient M.H. reported having lower back pain from a car accident in 2003. Dr. Mubang noted that Patient M.H. was the driver of a car that was rear-ended. He also noted that Patient M.H. did not lose consciousness during the accident and did not go to the emergency room. At the January 6, 2009, visit, Patient M.H. reported trying three alternative treatment methods for her pain. By her own report, Patient M.H. had not tried any of the other 18 alternative treatment options on Dr. Mubang’s checklist form, such as physical therapy, muscle injections, or surgery. In 2009, for unexplained reasons, Dr. Mubang began significantly increasing Patient M.H.’s opioid pain medication. In January 2009, he increased Patient M.H.’s Vicodin from 60 to 90 tablets per month, then in July 2009 from 90 to 120 tablets per month. On October 19, 2009, Dr. Mubang prescribed Patient M.H. ten 50 mcg patches of fentanyl in combination with 120 tablets of Vicodin. A 50 mcg fentanyl patch is intended to last for 72 hours; so, a prescription of ten patches is intended to last one month. Fentanyl is a very strong opioid. Based on Patient M.H.’s experience with opioids, Dr. Mubang’s prescribing fentanyl to Patient M.H. was potentially lethal. On November 16, 2009, Dr. Mubang discontinued fentanyl and started Patient M.H. on 90 15 mg tablets of oxycodone, which he increased to 120 tablets the next month. Dr. Mubang prescribed the oxycodone in combination with 120 tablets of Vicodin. At hearing, Dr. Mubang could not tell from his notes and was, therefore, unable to explain his rationale as to why he prescribed fentanyl to Patient M.H., or why he discontinued the fentanyl and started Patient M.H. on oxycodone. The limited documentation that was included in Dr. Mubang’s records contradicted his course of treatment, as he routinely documented that Patient M.H.’s pain was a two out of ten with medication. From March 8, 2010, to June 28, 2010, Dr. Mubang added and then discontinued prescribing Soma to Patient M.H. His records do not contain any justification for starting Patient M.H. on Soma or for stopping Soma. On May 3, 2010, Dr. Mubang ordered a urine drug screen for Patient M.H. The urine drug screen result was negative for the prescribed medication oxycodone. The standard of care required Dr. Mubang to ask about the reason for the aberrant result to determine whether she was taking the medications or diverting them. Depending upon Patient M.H.’s answer, he should have ordered a repeat urine drug screen at the following visit. Despite the negative test, Dr. Mubang continued to prescribe potentially lethal doses of oxycodone and Vicodin to Patient M.H. From January 10, 2005, through August 23, 2010, Dr. Mubang prescribed potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone to Patient M.H. inappropriately, in excessive quantities, and without justification. From January 10, 2005, through August 23, 2010, Dr. Mubang did not diagnose Patient M.H. with ADD or any other clinical indication to support his prescribing Adderall to Patient M.H. From January 10, 2005, through August 23, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing of the potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone to Patient M.H. Dr. Mubang did not diagnose Patient M.H. with intractable pain prior to prescribing to the patient the potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone. To meet the standard of care in his treatment of Patient M.H., Dr. Mubang should not have prescribed fentanyl to Patient M.H. without sufficient medical justification, as doing so was life threatening. Respondent should have referred Patient M.H. to specialists, such as orthopedics, physical therapy, and psychiatry. To the extent Dr. Mubang documented referrals to specialists, he should have followed up on his ordering of referrals to minimize the amount of medications he provided to Patient M.H., instead of escalating the amounts of pain medicine he prescribed. Patient B.D. From November 11, 2010, to November 8, 2012, Dr. Mubang provided pain management treatment to Patient B.D., a then 24- to 26-year-old female. In addition to lower back pain, Patient B.D. was also diagnosed with fibromyalgia. Dr. Mubang’s medical records for Patient B.D. contain a note from Dr. Indira Koshy, a prior treating provider, for a visit on August 24, 2010, in New York. Dr. Koshy noted that Patient B.D. was “entering rehab” and that Patient B.D. has seizures when she does not take her medications. Dr. Koshy’s note indicates potential for doctor shopping. At no point during his treatment of Patient B.D. did Dr. Mubang address the note from Dr. Koshy, specifically; Patient B.D.’s entry into rehabilitation; Patient B.D.’s seizures when she did not take her medications; or Patient B.D.’s potential for doctor shopping. Dr. Mubang previously treated Patient B.D. at Care Point Medical Center as a covering physician. He testified that when covering as a physician he provided “continuation of care” and that his practice was not to change a patient’s medication. Despite his testimony, when covering at Care Point Medical Center, Dr. Mubang increased Patient B.D.’s oxycodone from 210 tablets per month to 240 tablets per month. Then, on November 11, 2010, when Patient B.D. visited his practice, Dr. Mubang decreased her oxycodone from 240 to 180 tablets. As discussed below, this decrease came after he received notice of Petitioner’s investigation. From November 11, 2010, until May 24, 2012, Dr. Mubang prescribed Patient B.D. 180 30 mg tablets of oxycodone, 30 or 60 10 mg tablets of methadone, 60 350 mg tablets of Soma, and 30 0.5 mg to 2 mg tablets of Xanax monthly. On June 21, 2012, Dr. Mubang changed Patient B.D.’s prescribed muscle relaxant from Soma to baclofen; and on July 19, 2012, he changed Patient B.D.’s prescribed anxiolytic medication from 60 0.5 mg tablets of Xanax to 60 2 mg tablets of clonazepam. Dr. Mubang did not document any justification for the foregoing medication changes. From September 13, 2012, until November 8, 2012, Dr. Mubang prescribed 112 8 mg tablets of Dilaudid, 28 10 mg tablets of methadone, and 60 tablets of clonazepam to Patient B.D. monthly. On June 23, 2011, Dr. Mubang performed a urine drug screen on Patient B.D. The drug screen was negative for benzodiazepines, even though he prescribed Xanax to Patient B.D. The urine drug screen was positive for methadone, despite Dr. Mubang’s testimony that his urine drug screen could not detect methadone. On December 8, 2011, and June 21, 2012, Dr. Mubang performed urine drug screens on Patient B.D. Both drug screens were negative for the prescribed medication methadone. The standard of care required a reasonably prudent physician to question the patient about the aberrant urine drug screens results and cease prescribing methadone to a patient whose urine drug screen was negative for the drug. Despite the negative test results, Dr. Mubang continued to prescribe methadone to Patient B.D. From November 11, 2010, through November 8, 2012, Dr. Mubang neither performed nor documented performing an adequate history or physical examination to justify his prescribing of the potentially lethal controlled substances to Patient B.D. From November 11, 2010, through November 8, 2012, based on Patient B.D.’s history and physical findings, Dr. Mubang’s prescribing of the controlled substances to Patient B.D. was excessive and without justification. From June 23, 2011, through November 8, 2012, Dr. Mubang failed to address Patient B.D.’s aberrant urine drug screen results. To meet the standard of care in his treatment of Patient B.D., Dr. Mubang should not have prescribed the quantity and combination of drugs he prescribed to Patient B.D. He should have referred Patient B.D. for a rheumatology consult to confirm or rule out fibromyalgia and other diseases. He should have offered more physical therapy, and other, non-opioid modalities of care, and he should have routinely followed up with Patient B.D. to ensure that she was complying with his orders. Dr. Mubang testified that Soma was part of the “holy trinity,” which is a slang drug term used to refer to the prescription combination of oxycodone, a benzodiazepine, and Soma. He prescribed the “holy trinity” to five of the six patients in this cause. Dr. Mubang’s Medical Records Dr. Mubang’s medical records for the six patients, who are the subjects of the Administrative Complaints, were generally lacking in specificity to justify the level of his prescribing. Some examples common to the patients at issue illustrate these shortcomings. For each visit for each of the patients, Dr. Mubang noted that the patient had straight leg raise pain at 30 degrees, even though he testified that a patient can have straight leg raise pain at 15, 20, 30, or 45 degrees. Maybe this was a coincidence, but more credibly it is a pattern of sloppiness or autofill by the doctor. Also, for each patient, Dr. Mubang routinely drew a line down one leg of the anatomical figure on his progress notes indicating radiculopathy, regardless of where the patient reported pain. At hearing, on multiple occasions, Dr. Mubang could not determine his rationale for changing a patient’s medication regimen, based on his progress notes. His own expert, Dr. Simopoulos, testified that, “there's not much rationale on the plans in--in Dr. Mubang's notes in general.” Dr. Mubang tried to justify the lack of documented rationale by explaining that if a subsequent treating physician needed to know why he made medication changes, the physician would just call him and ask. While this should be true in an ideal world, his attempted justification is contrary to the purpose of medical records, which is continuity of care. No doctor, regardless of his education and experience, can be expected to remember every detail about every patient when he only sees the patient periodically. The medical record and doctor’s notes comprise his guide to ensuring the patient receives continuous, appropriate care. In addition to lacking in rationale, both experts were unable to read some of Dr. Mubang’s handwritten notes due to legibility. His own expert testified that, “The hardest part about these records is, obviously, how legible they are. I wish they were more legible.” Dr. Mubang’s medical records were inadequate for all six of the patients at issue here. Dr. Mubang’s Defenses Dr. Mubang passionately testified at hearing that he practices addiction medicine, that he prescribes Suboxone, and that his goal is to titrate patients’ medication. However, Dr. Mubang’s interest in addiction medicine and Suboxone is a recent phenomenon. In his 2012 deposition, he did not mention practicing addiction medicine, and the word Suboxone does not even appear in that deposition. Dr. Mubang titrated the medication he prescribed for four of the six patients in this cause. His reasoning for titrating the patients’ medication changed from his deposition testimony to his hearing testimony. In his 2018 deposition, he testified that he reduced the patients’ pain medication because the patients’ conditions were improving, and his goal was to titrate the medication. At hearing, he asserted the theory that he changed his prescribing practices because pharmacies contacted him and told him that they would no longer fill prescriptions written for such large quantities. The first of these is based upon a consideration of quality of care, while the second is based upon the practical reality of changing pharmacy practices as the dangers of over-prescribing opiates started to become more prevalent in the eyes of health professionals and regulators. On September 2, 2010, Investigator Victor Troupe personally served Dr. Mubang with a notice of investigation and a subpoena for medical records for Patients A.M., B.B., C.C., W.B., and M.H., among others. Following receipt of the notice of investigation, the doctor radically changed his prescribing practice for the patients in this cause. For ten months, Dr. Mubang prescribed Patient A.M. 270 tablets of oxycodone. Then on September 24, 2010, three weeks after being served by Petitioner, Respondent reduced Patient A.M.’s prescription of oxycodone from 270 tablets to 210, and then from 210 tablets to 180. For five months, Dr. Mubang prescribed Patient C.C. 290 tablets oxycodone. Then on September 9, 2010, Respondent reduced Patient C.C.’s prescription of oxycodone from 290 tablets to 210. At the patient’s next visit on January 5, 2011, Dr. Mubang reduced the patient’s prescription of oxycodone from 210 tablets to 180. Dr. Mubang also reduced Patient C.C.’s methadone. For five months, he prescribed 180 10 mg tablets of methadone to Patient C.C., but he reduced that number first to 60 tablets, then to 30, then discontinued the prescription. Further, in a matter of three visits, the doctor went from prescribing Patient C.C. 470 pain pills per month to 180 tablets. For ten months, Dr. Mubang prescribed Patient W.B. 270 tablets of oxycodone. Then on November 6, 2010, Patient W.B.’s first visit after the doctor received notice of the investigation, he reduced Patient W.B.’s prescription of oxycodone to 240 tablets, then to 210 on the next visit. For five months, Dr. Mubang prescribed Patient B.D. 240 tablets of oxycodone. Then on November 11, 2010, Patient B.D.’s first visit with the doctor after he had received notice of the investigation, he reduced Patient B.D.’s prescription of oxycodone to 180 tablets. The logical explanation for Dr. Mubang’s sudden reduction in amounts of pain medication prescribed is that the Petitioner’s notice of investigation triggered him to change his prescribing practice. The notice of investigation might have been his “eureka” moment or it might have served as a wake-up call to him concerning his prior over-prescribing practices. The evidence clearly and convincingly demonstrates that Dr. Mubang used little critical medical judgment when prescribing dangerous controlled substances to the patients in this matter. His diagnoses were based solely on patient report, and his primary tool for treating these patients was the prescription of controlled substances without first exhausting less harmful treatment modalities or combining lower doses of controlled substances with his patients seeking other treatment modalities.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order: finding that Respondent, John Nkolo Mubang, M.D., violated sections 458.331(1)(nn), 458.331(1)(q), 458.331(1)(t), 458.331(1)(m), and 458.331(1)(cc), Florida Statutes, as charged in Petitioner’s Administrative Complaints; and revoking Dr. Mubang’s Florida medical license. DONE AND ENTERED this 25th day of June, 2019, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of June, 2019. COPIES FURNISHED: Chad Wayne Dunn, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Dale R. Sisco, Esquire Sisco-Law 1110 North Florida Avenue Tampa, Florida 33602 (eServed) Zachary Bell, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Claudia Kemp, JD, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 (eServed) Louise Wilhite-St Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed)

Florida Laws (12) 120.569120.57120.6820.43456.072456.079456.50458.326458.3265458.331766.102893.03 Florida Administrative Code (5) 28-106.21764B8-8.00164B8-8.001164B8-9.00364B8-9.013
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BOARD OF NURSING vs. LOIS E. ANDERSON BAILEY, 83-001948 (1983)
Division of Administrative Hearings, Florida Number: 83-001948 Latest Update: Oct. 04, 1990

Findings Of Fact At all times pertinent to the issues contained herein, Respondent, Lois E. Anderson Bailey, was a licensed practical nurse in the State of Florida under license number 12519-1. During the period between July, 1982 and January, 1983, and for an unknown period both before and after that time, Dr. Allan R. Varraux was a pulmonary specialist who, as a part of his practice, performed bronchoscopies at ORMC. As a routine part of this practice, Dr. Varraux utilized a cocaine solution to spray the back of the throat of his patients as an anesthetic prior to inserting the bronchoscope. Cocaine is also used as an anesthetic after the bronchoscope is inserted because it lasts between one-half an hour to forty-five minutes as opposed to xylocaine which lasts only fifteen minutes or so. Dr. Varraux also prefers to use cocaine over xylocaine because the latter often causes spasms in the patient. During this period, Dr. Varraux knew the Respondent, who was nursing supervisor of the Endoscopy section at the time, and discussed with her the controls for the use of cocaine for this purpose because cocaine is a controlled substance. At no time did Dr. Varraux ever discuss with Respondent the potential for the substitution of xylocaine for cocaine in this procedure nor did he ever approve its substitution. On or about January 18, 1983, Dr. Varraux wrote a letter to Mr. Holton, Director of the hospital pharmacy, asking for a survey of cocaine use at ORMC. He did this because of a survey done at another hospital at which he also practiced with which he was familiar to be sure that the amount of cocaine he was using was reasonable. The audit revealed that at the time in issue here, no cocaine was dispensed by the pharmacy for the Endoscopy section. Dr. Varraux considered this odd because he was ordering cocaine solution for the bronchoscopies he was performing and as a result, some cocaine should have been issued. He subsequently found out that xylocaine was being substituted for cocaine. He had not authorized the substitution and was greatly concerned because of the potentially serious impact the substitution might have on a patient if the patient were allergic to xylocaine and the physician did not know that the substitution had been made. In his opinion, it is not good medical practice to substitute xylocaine for cocaine without the doctor's orders and without informing the physician of the change. In practice, the cocaine is injected with a syringe into the apparatus being utilized during the bronchoscopy. At that point, the order for the use of cocaine is a verbal order which is, thereafter recorded in the nurse's notes and in the doctor's dictated report concerning the procedure. Since there is no standard procedure for this operation, Dr. Varraux established, in discussions with the Respondent, his general procedures which in all cases included the use of cocaine as an anesthetic. Respondent actually assisted in very few of Dr. Varraux procedures. Eighty-five percent of his procedures were done with Ken Rosenau assisting and Mary Ann Hinds assisted in others. However, Respondent was the supervisor of the endoscopy section and if there was a problem, Dr. Varraux would go to her first. Lynn W. Capraun, an instructor of respiratory therapy at Valencia Community College, and an advisor in that area to ORMC, was asked by Mr. Rogers to audit the endoscopy section records for bronchoscopies performed from July, 1982 through January, 1983. His audit was limited to only those on a list of procedures given him by Mr. Rogers and he is not aware of what percentage of the total bronchoscopy load this list consisted of. However, as a part of this audit, he reviewed for each specific case the doctor's clinical resume' and the nurse's notes to see what the doctor called for and what was in fact done. Based on his audit, it appeared that during the period in question, more than 203 ml of cocaine had been ordered by physicians but there was no supporting documentation in the nurse's notes to indicate that the cocaine had been administered even though there was documentation for the use of other drugs. Here, it should be noted that Mr. Capraun is also the partner of Mr. Rogers in a private respiratory therapy business. The records of the pharmacy at ORMC revealed that the last issue of cocaine too the endoscopy section prior to the audit was made in July, 1982. Prior to that time, as far back as 1981, records indicated that the pharmacy had issued 60 ml of cocaine solution every three or four weeks. All issues are reflected as such issues are logged and the name of the individual to whom the drug is issued, who must be licensed, is retained. In addition, pharmacy records reflected no issue of any controlled drug, not only cocaine, to the endoscopy section between late October, 1982 and January 3, 1983. After Respondent was suspended on January 19, 1983, Mr. Holton examined the drug sheets kept in the endoscopy section and the drugs kept on the floor. He found three bottles of cocaine solution, one of which contained 60 ml and the other two contained 40 ml. Analysis of the contents of one bottle reflected the solution at 3.9 percent cocaine which is acceptable. The other two bottles, however, were at a lower strength - one at .5 percent and the other at 1.4 percent cocaine. Though there were three bottles of solution, only two records to support these bottles were found. One was dated May 21, 1982 and the other, June 23, 1982. Cocaine is issued by the pharmacy only upon the presentment of a proof of use sheet which reflects the fact that the previous issue has been used up and it is the practice of the pharmacy, according to Mr. Holton, not to issue new supplies of a controlled substance without a proof of use sheet to show the use of the previous issue. The records of the hospital reflect that the Endoscopy section is a small user of any controlled drug. From the above, an inference can be drawn that cocaine was improperly removed from the Endoscopy section. However, from review of the evidence as a whole, not only that already discussed but that to be discussed as well, it is impossible to determine for certain that there was a loss and if so, who was responsible for it. It certainly cannot be said with any degree of certainty that the Respondent either took it or knew who did. When Mr. Rogers received the letter from Dr. Varraux regarding the use of cocaine in the Endoscopy section of his department, he went to look for the Respondent to discuss the problem with her. He found that she had gone for the day and so he discussed the situation with Mrs. Williams, one of Respondent's assistants, who advised that Respondent had, at times, asked her to substitute xylocaine for cocaine. The following day, he looked into the situation further and after talking with his supervisor, called in Respondent and showed her Dr. Varraux's letter. He says Respondent first indicated she was aware of the situation - then changed her position. She again changed her position, indicating that she was aware of only one incident and that she had discussed with the employees of the section the illegality of the practice advising them not to do it. Mr. Rogers was told by his employers that he could suspend the Respondent if he felt it to be necessary. As a part of his inquiry, he discussed the matter with Mr. Holton and other employees of the department whom he asked to make statements regarding the alleged substitution. His requests were for specifics of the incidents - if they knew of the practice, who had asked them to do it, and things of that nature. When he got the employees' statements back, he reviewed them and took them to the personnel office for advice. Thereafter, he notified Respondent by mail of her termination. Mary Ann Hinds worked at the Endoscopy section as an LPN during the period July, 1982 through September, 1983 assisting physicians, including Dr. Varraux, in bronchoscopy procedures. She contends that at some time during October or November, 1982, Respondent called her into the office and advised that cocaine would no longer be used in bronchoscopy procedures and xylocaine would be substituted. She says she was told to chart the initial 4 percent xylocaine solution but not the 10 percent xylocaine solution she would give to the doctor without telling him of the substitution even though the doctor might ask for cocaine. She says that Ms. Bailey told her this would be done because during a prior procedure when the assistant used xylocaine instead of cocaine, Dr. Varraux did not know the difference and Bailey concluded that they would use the xylocaine instead of cocaine thereafter. Ms. Hinds did not question this because Respondent was the head of the department. Ms. Bailey was, in her opinion, difficult to talk to and as a result of these instructions, she followed this new procedure from the time of the instruction on through January, 1983. During this period, she saw Mr. Rosenau and Mr. Hooper also do the same thing. Although Ms. Hinds was quite definite in her testimony regarding the conversation with Ms. Bailey, she is significantly less sure of her testimony regarding control of drugs on the ward. For example, she cannot recall ever signing any proof of use forms. She contends that the LPNs and technicians did not sign off on the drug book. They would tell the Respondent what was used and she made the entries. When cocaine was to be used, she got it from a bottle in the Respondent's office. Helen Williams also worked under Respondent in the endoscopy section until January, 1983 assisting doctors with bronchoscopy procedures. When she first came to work in this section, she did not know that cocaine was being used. She recalls that in a conversation shortly after she came to work, Respondent told her they were using 4 percent xylocaine solution in place of a cocaine solution because they had done it one time with Dr. Varraux and he did not notice and as a result, they continued to follow this procedure. However, Ms. Williams, though she subsequently heard from Rosenau that substitutions were being made, never saw it done nor did she ever substitute. Though she says she advised Respondent she didn't think this substitution was a good idea, Respondent is supposed to have replied that this is the way it was done. Ms. Williams accepted Ms. Bailey's word when told that there was no cocaine on the unit and that cocaine was not being used even though the drug book at the time showed 27 cc of cocaine solution unused and on the unit. She discussed this with Ms. Bailey and concluded that if her supervisor knew about it, that was sufficient, and she did not report this to anyone else. She also did not report her knowledge of the substitutions being made to anyone else because she did not feel it was her place to do so since Respondent was the section head and knew about it. Ted Hooper, also an endoscopy technician, did bronchoscopies with Dr. Varraux for several years and toward the end, substituted xylocaine for cocaine in these procedures without telling the doctor what he was doing. He had seen Rosenau substitute xylocaine while he was watching procedures to learn how to do them before becoming a technician. When he asked Bailey about this, he says, she responded that it was done, for one reason, because it was cheaper for the patient. She also told him it was all right to do this as it had already been taken care of. She did not tell him, outright, to make the substitution but because she had said it was taken care of, he thought it was permissible. However, he also contends that he observed cocaine being used by Hinds and others in Dr. Varraux' cases after he became a technician in July, 1982. James E. Hardy, in October, 1982, employed as a transporter in the Endoscopy section of ORMC, also assisted in bronchoscopies, working at times with Dr. Varraux and he was aware of the practice of substituting xylocaine for cocaine in these procedures. When he first went to work in the section, he says, he was asked to substitute by Respondent who told him it was being done because it was cheaper for the patient but refused to do so. To his knowledge, however, he does not recall seeing the substitution actually performed. On one bronchoscopy he recalls, which he set up, cocaine was used which he got from Respondent. Mr. Rosenau testified at the March, 1985 hearing. He clearly indicated that xylocaine was substituted for cocaine in the procedures performed by Dr. Varraux and the cocaine they had on hand was rarely taken from the drug locker. He absolutely denies that during all the period of time he was working with Respondent, he ever discussed with her or admitted to her that he had substituted xylocaine for cocaine nor did Respondent ever tell him to do this. In fact, he cannot recall how this practice got started. Here it should be noted that Rosenau, Hardy, and Hooper were all friends of Mr. Rogers and at least Rosenau and Hardy owed their employment at the time to him. Respondent was recognized by Dr. Bone as partially responsible for the growth of the Endoscopy section at ORMC. He recalls her as being an exceptional nurse: reliable, dependable, and proficient - a perfectionist who did an excellent job. He had complete confidence in her ability and in her honesty and integrity. If he asked her to do something, she did it more reliably than others. Because of her perfectionist nature, however, she may have alienated people and turned them away, but he never had any doubts about her nor did he ever have any reports from other doctors that she did not do her job well. He worked with her until she left the hospital. She was a "take charge" person but never exceeded her authority or deviated from prescribed procedures or doctors' orders. This opinion of Respondent is shared by Christina Stephens who worked under Respondent for a period of time. She found the Respondent to be stern, regimented as to order of procedures, and very organized, but she never saw any irregularities by the Respondent in carrying out doctor's orders. As to Mr. Rosenau, however, of whom she also had some knowledge, she found him to be somewhat unprofessional in his patient care and actions and brought this to the attention of the supervisor by written report on several occasions. This was, however, several years prior to the time in issue here and she has not worked with him since 1976 nor does she have any knowledge of his performance since that time. Respondent began work at ORMC after she was a student in the respiratory therapy program there at the request of Mr. Rogers. She started as a pulmonary rehabilitation technician part time. At that time, there were only two employees in the section. When, after a few months, the supervisor left, Respondent took over. Over a period of time, new procedures were introduced including gastroenterology and Respondent was trained in them as she went. She began doing more of the latter than pulmonary rehabilitation even though she remained head of that section. She was then asked to help set up an Endoscopy section and started doing those procedures as well. Rosenau was working on the floor in the respiratory therapy section and was having trouble with his supervisor. As a result he wanted to come to work in the Endoscopy section and Respondent arranged a transfer for him even though he had little experience in endoscopy and none in gastroenterology. When she first started working with gastroenterology, the patient and his medication were brought into the section. When the procedure was finished, the unused medication was sent back with the patient. As the section got bigger however, and more procedures were accomplished, this practice began to hold things up. The physicians requested that medications be kept in the section for their use. Respondent resisted this because she did not feel there were sufficient safeguards available to maintain proper control. Nonetheless, the physicians pushed for it but the change did not happen until Dr. Varraux became insistent that the medications be kept there. He worked through Rogers and Holton to get a narcotics box installed on the section. When this was done Mr. Holton gave two sets of keys to the box to Mr. Rogers who immediately turned one set over to the Respondent and gave one set to Rosenau. When Dr. Varraux decided to use cocaine for anesthesia he discussed it with Rogers and Holton since Respondent did not have the authority to request it. As a result, the pharmacy began dispensing 60 ml bottles of cocaine solution for use in bronchoscopies with a control sheet accompanying it to be kept in the locked portion of the bronchoscopy cart. Again, Respondent and Rosenau both had access to this cart. In fact, Rosenau had access to every key that Respondent had except the one to her desk. According to the Respondent, she had difficulty with Rosenau regarding drugs on several occasions when he would draw narcotics into syringes, a procedure he was neither trained nor authorized to do. In the Spring of 1982, bronchoscopies were done by nurses who would give valium but cocaine was administered by Rosenau only. However, when cocaine was used, Respondent would sign off on the sheets along with others whose names appeared on the form as administers of the drug. In mid-1982 bronchoscopies were transferred to the respiratory therapy section, by then headed by Rosenau, but this did not seem to work out and after a short period, the procedure was returned back to the endoscopy section, with Rosenau still doing them under the overall supervision of Respondent. Respondent contends that she did not train people to do the bronchoscopy procedures. Rosenau had been doing this for months before all of this took place. Ms. Hinds came to work in late July, 1982, and Respondent had no control over bronchoscopies at that point as they were in Rosenau's section. As to Hardy, she characterized him as an errand boy who was never trained to do bronchoscopies and with whom she never discussed them. She did, however, have a discussion with Rosenau on one occasion about cocaine. She relates that on this particular instance, Rosenau advised her in confidence that he had substituted Xylocaine for cocaine by mistake on a bronchoscopy performed by Dr. Varraux and wanted to get it off his chest. He assured her that if she would give him another chance, he would never let it happen again. Here, even though Rosenau had a previous disciplinary record which she had discussed with Rogers, she decided to take no action because she felt it would be fruitless. Rogers had taken no corrective action against Rosenau in the past and she had no reason to believe he would do so now. Rosenau, as was seen above, denies this conversation but no doubt it did occur. Respondent does not know why she was terminated and was shocked by the action. Rogers had mentioned something about cocaine and had given her an opportunity to resign but she refused. She claims to know nothing about the dilution of the cocaine solution. She claims to know nothing of the substitutions of xylocaine for cocaine other than that reported to her by Rosenau. She categorically denies ever telling Hinds, Williams, or anyone else to substitute xylocaine for cocaine. Counsel for Respondent spent considerable time attempting to establish that the charges against her are the result of a plot by Rogers, Rosenau and others at the hospital to remove her from her position. At best, the evidence shows a lack of control within the respiratory therapy section. There does appear to be a decided relationship between Mr. Rogers and Mr. Rosenau but Respondent has failed to establish that this relationship manifested itself in a plan to bring about her unjustified separation. The evidence establishes that xylocaine was substituted for cocaine and there is some substantial evidence to indicate the Respondent had some knowledge or information indicating that this was being done. There is no credible evidence, however, to establish that Respondent herself substituted xylocaine for cocaine or instructed or directed anyone else to do so. At worst hers is a sin of omission rather than commission.

Florida Laws (1) 464.018
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs JOHN P. CHRISTENSEN, M.D., 10-002814PL (2010)
Division of Administrative Hearings, Florida Filed:West Palm Beach, Florida May 24, 2010 Number: 10-002814PL Latest Update: Aug. 19, 2011

The Issue Whether the Respondent committed the violations alleged in the Amended Administrative Complaint dated March 26, 2010, and, if so, the penalty that should be imposed.

Findings Of Fact Based on the oral and documentary evidence presented at the final hearing, the facts stipulated to by the parties in the Joint Prehearing Stipulation, and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 456.072, Fla. Stat. The Board of Medicine ("Board") is the entity responsible for regulating the practice of medicine and for imposing penalties on physicians found to have violated the provisions of section 458.331(1). See § 458.331(2), Fla. Stat. At the times pertinent to this proceeding, Dr. Christensen was a physician licensed to practice in Florida, having been issued license number 92135, and he practiced with the A1A Health & Wellness Clinic ("Clinic"), specializing in pain management. In 1975, Dr. Christensen received a degree in chiropractic, and he specialized in chiropractic orthopedics. Dr. Christensen has been practicing chiropractic orthopedics in the Palm Beach, Florida, area since 1975, although he took time away from his practice to attend medical school and to obtain a master's degree in public health. Dr. Christensen received his medical degree in 1995, and he completed a one-year internship in internal medicine. Dr. Christensen was certified in preventive medicine by the American Board of Preventive Medicine on January 22, 2007, and, after passing an examination, he was credentialed in March 2007 by the American Academy of Pain Management. Between February 9, 1997, and February 1998, Dr. Christensen was certified as an addiction professional by the American Association of Acupuncture and Oriental Medicine and the American College of Addictionology and Compulsive Disorders after having taken a 120-hour program in addictionology. Dr. Christensen first saw A.L. at the Clinic on February 12, 2007. At the time, A.L. was 21 years old, having been born on September 17, 1985. At the February 12, 2007, office visit, A.L. completed a Personal History form in which he stated that he was self- employed and worked in construction; that his major complaint was knee and back pain; and that the condition of which he complained began when he was 13 years old, which would have been in or about 1998. A.L. also noted on the Personal History form that he had seen other doctors for "pain management," but he did not include the names of any of the doctors who had provided pain management treatment. Dr. Christensen completed the New Patient History Form at A.L.'s first office visit. He noted that A.L. complained of intense, sharp, incapacitating pain in his left knee, with associated pain in his lower back. A.L. reported that he had had multiple surgeries on his knee that had been unsuccessful. Dr. Christensen performed a general examination of A.L. to confirm that he was alert and oriented and that his organ systems functioned properly. Dr. Christensen noted that A.L. was thin, but he did not identify any abnormal finding. Dr. Christensen did note that A.L. complained of anxiety. Because of A.L.'s complaints, however, Dr. Christensen focused his examination on A.L.'s left knee and lower back. Dr. Christensen observed scars on A.L.'s left knee, which confirmed the multiple surgeries that A.L. reported, and he also noted muscle atrophy of A.L.'s left leg, a condition that Dr. Christensen attributed to lack of exercise of the left leg. Dr. Christensen performed several orthopedic tests targeted at A.L.'s left knee and lower back, and Dr. Christensen's objective physical examination confirmed A.L.'s subjective complaints of pain. The differential diagnosis noted by Dr. Christensen on the New Patient History Form was multiple failed knee surgeries with associated lower back pain and lumbar disc syndrome. Dr. Christensen concluded that A.L. most likely had a lumbar disc problem because of A.L.'s abnormal gait resulting from the knee injury and the resulting pressure on A.L.'s pelvis. Dr. Christensen also noted on the New Patient History Form that A.L. reported that, each month for years, he had taken 60 to 90 80-milligram tablets of Oxycontin; 400 to 600 30- milligram tablets of Roxicodone; 200+ 40-milligram tablets of Methadone; 60 to 90 2-milligram tablets of Xanax; and 3 bottles of Oxifast. Based on these medications, dosages, and quantities, Dr. Christensen considered A.L. overmedicated, and he intended, during his treatment of A.L., to gradually reduce the amount of medications prescribed for A.L. Oxycontin and Methadone are pain medications, and Oxycontin and Roxicodone are trade names for the generic drug Oxycodone. Oxifast is a liquid form of Oxycodone, and Xanax is a drug used to treat anxiety. Both Oxycodone and Methadone are classified as schedule II controlled substances in section 893.03(2), Florida Statutes, and have a high potential for abuse; Xanax, which is the trade name for the generic drug Alprazolam, is classified as a schedule IV controlled substance in section 893.03(4), with a low potential for abuse relative to schedule I, II, and III controlled substances. As part of his initial office visit with Dr. Christensen, A.L. signed a Pain Management Agreement, in which he agreed that, among other things, he would not take any pain medications not prescribed by Dr. Christensen or seek treatment from any other doctors in order to obtain pain medications; prescriptions would be filled at the same pharmacy, which A.L. identified as "Gordons Pharmacy"; he would take the medications prescribed in the manner indicated on the label; he agreed to random urine drug tests; and he understood he would be discharged by Dr. Christensen if he failed to abide by the Pain Management Agreement. Dr. Christensen went over this agreement with A.L. during this initial office visit, and he emphasized that the agreement was a legal document that, if breached, would result in A.L.'s being discharged as Dr. Christensen's patient. In his typed notes for A.L.'s February 12, 2007, office visit, Dr. Christensen stated: Subjective: Mr. [L] indicated on his first visit today that he is feel constant severe pain in his left knee causing him to limp which refers pain to the lower back. Mr. L additionally reports restricted movement pain localized in the right lumbar, left lumbar, right lower lumbar area, and left lower lumbar area. Mr. [L] stated that for years he is made fairly comfortably by taking pain pills but his low back pain is a lot more uncomfortable due to bending, driving, lifting, and standing. He also stated today that he is experiencing constant severe pain in the area of the left knee joint and related he has had 7 failed knee surgeries since he was 13 years old. Mr. [L] additionally made particular comment about stiffness, restricted movement, and inflexibility pain localized in the left kneecap. Mr. [L]'s knee joint pain feels worse due to bending, standing, and walking. He states that taking pain pills reduces the severity of the pain. Dr. Christensen also noted in his typed notes that A.L. rated the level of knee joint and low back pain at nine on a scale of one to ten; Dr. Christensen's handwritten notes indicate that A.L. rated the level of pain at "10+". Dr. Christensen's assessment, as reflected in his typed notes, was that A.L. showed a persistent chronic symptomatology; that is, Dr. Christensen considered A.L.'s knee and lower back pain to be a chronic and stable condition, with no hope of improvement given that A.L. rejected additional surgery on his left knee as an option. Dr. Christensen also requested at the February 12, 2007, office visit that A.L. provide him with any MRI reports or other radiologic studies as soon as possible, and A.L. provided several radiological consultation reports the day after his initial office visit. The reports included an MRI of A.L.'s left knee done on or about April 1998; an MRI of A.L.'s lumbosacral spine done on or about December 2000; an MRI of A.L.'s left knee done on February 9, 2001; an MRI of A.L.'s left knee done on August 23, 2002; and a radiological study of A.L.'s cervical spine and a CT scan of A.L.'s brain in April 2006. Dr. Christensen reviewed the reports and confirmed that A.L.'s diagnosis was an osteochondral defect of his left knee, most likely from a sports injury. Dr. Christensen did not order additional diagnostic studies of A.L.'s knee and lower back because he concluded, as a chiropractic orthopedist and based both on his objective findings from the physical examination of A.L. and on his review of the radiological reports, that A.L.'s injury would not get better on its own; that additional diagnostic tests would show only that A.L.'s condition had gotten worse; and that the results of additional diagnostic tests would not change his diagnosis or treatment of A.L. The treatment plan for A.L. that Dr. Christensen outlined in his typed notes is as follows: One month appointment is scheduled for the patient. Pain medication that he was taking was reviewed and a decreased amount of pain medicine was prescribed. He was given a book on Subutex/Suboxone. I covered our pain management agreement, cautioned of side effects, addiction, health concepts, physical therapy, patient is too young for knee replacement, etc. Our plan is to reduce the patients [sic] present intake of pain meds . . . to a lessor [sic] amount each month as we are able. Dr. Christensen believed that A.L. was taking too much pain medication. He wanted to help A.L. undo the damage that had been done by the excessive pain medications that Dr. Christensen believed had been prescribed for A.L., and Dr. Christensen planned to reduce the amount gradually to a more appropriate level of medication. Accordingly, on February 12, 2007, Dr. Christensen wrote A.L. prescriptions for 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day; 300 30-milligram tablets of Roxicodone, with instructions to take two tablets five times per day; and 60 2-milligram tablets of Xanax, with instructions to take one tablet two times per day. Based on the quantities and dosages of medications that A.L. reported he was taking as of February 12, 2007, Dr. Christensen eliminated the prescriptions for Oxycodone and Oxifast and significantly reduced the number of 30-milligram Roxicodone tablets and 40-milligram Methadone tablets A.L. could take each month. Dr. Christensen prescribed Xanax for A.L. because A.L. reported to Dr. Christensen that he had anxiety; because Dr. Christensen observed that he was anxious during the office visit and knew that pain could cause anxiety; and because A.L. reported to Dr. Christensen that he had been taking Xanax prior to February 12, 2007. Although Dr. Christensen prescribed less Xanax for A.L. than A.L. reported that he had been taking, Dr. Christensen did not want to A.L. to stop taking Xanax abruptly because A.L. could have seizures and die. The prescriptions written for A.L. by Dr. Christensen significantly decreased the amount of pain medication A.L. was reportedly taking prior to February 12, 2007, but Dr. Christensen was satisfied that the prescriptions would provide a sufficient amount of medication to control A.L.'s pain. Dr. Christensen felt that he could not refuse to prescribe pain medications for A.L. on February 12, 2007, because, once a patient has been on pain medications for years, as A.L. reportedly had, stopping the pain medications abruptly could result in very severe withdrawal symptoms. In addition, Dr. Christensen was concerned that, if he did not prescribe pain medications for A.L., A.L. would not continue his treatment with Dr. Christensen. As part of his treatment plan, Dr. Christensen also discussed with A.L. on February 12, 2007, health concepts such as improving his diet, getting exercise, considering physical therapy, setting goals, and increasing spiritual awareness. In addition, he gave A.L. information on Suboxone, a drug used primarily to prevent withdrawal symptoms when the amount of opioids such as Roxicodone is significantly reduced. Although A.L. was not interested in discussing Suboxone at the February 12, 2007, office visit, Dr. Christensen intended to continue discussing the drug with A.L. at subsequent office visits because Dr. Christensen's ultimate plan was to wean A.L. off of opioids completely. A.L. continued treatment with Dr. Christensen until June 29, 2007, seeing Dr. Christensen on March 12, 2007; April 10, 2007; May 7, 2007; June 2, 2007; and June 29, 2007. As recorded in Dr. Christensen's typed notes, A.L. complained at each office visit of "constant severe pain" in his lower back and his left knee area, with restricted movement in the lower back area and "stiffness, restricted movement, and inflexibility pain localized in the left kneecap." At each office visit, A.L. rated his knee and/or lower back pain at nine on a scale of one to ten, except that, at the office visit on May 7, 2007, A.L. rated his knee joint pain at eight on a scale of one to ten. Dr. Christensen reviewed A.L.'s systems at each office visit and conducted a physical examination focused on A.L.'s left knee and back. Dr. Christensen's assessment of A.L.'s status at each office visit was that his condition was chronic and/or stable. At A.L.'s March 12, 2007, Dr. Christensen prescribed 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day; 300 30-milligram tablets of Roxicodone, with instructions to take two tablets five times per day; and 60 2-milligram tablets of Xanax, with instructions to take one tablet two times per day. In his handwritten notes of the March 12, 2007, office visit, Dr. Christensen noted that A.L. was stable on the pain medications prescribed. On March 12, 2007, A.L. also completed a Pain Outcomes Profile, in which he rated his pain generally as five or six on a scale of one to ten; A.L. rated his level of anxiety as seven on a scale of one to ten. In his handwritten notes of the April 10, 2007, office visit, Dr. Christensen stated that he had a long discussion with A.L. about weaning him off of the pain medications and developing goals for doing so. Dr. Christensen drew a graph in his notes of the April 10, 2007, office visit to illustrate his discussion with A.L. about taking one 30-milligram Roxicodone ten times at a time instead of two. Dr. Christensen noted that A.L. wanted to take the Roxicodone tablets more often than ten times per day, and Dr. Christensen explained to A.L. that he needed to take enough pain medication to control his pain but not enough that he would go into a state of euphoria because that would lead to addiction. Dr. Christensen expanded on his point about weaning A.L. off of the large dose of Roxicodone in his typewritten notes of the April 10, 2007, office visit: I explained the concept of 2 roxicodone's [sic] (60 mg) verse [sic] 30 mg taken more often. 2 tabs can cause excess, waste, build tolerance and the patient will run out of meds. Taking the roxicone [sic] 30 mg tablets one at a time will allow the patient to dose himself better, decrease tolerance, reduce waste, laste [sic] longer. Less pain, and ultimately take less pain meds. I showed him how 240 roxies would provide more pain relief than 300 roxies if taken 1 at a time more often then [sic] taking 2 or more at a time which is how the patient was taking them. On April 10, 2007, Dr. Christensen prescribed 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day and 60 2-milligram tablets of Xanax, with instructions to take one tablet two times per day. Dr. Christensen also prescribed 300 30-milligram tablets of Roxicodone, but he instructed A.L. to take one tablet ten times per day rather than two tablets five times per day. A.L. completed a Pain Outcomes Profile at the April 10, 2007, office visit, and he rated his pain level generally at five on a scale of one to ten; A.L. rated his level of anxiety at seven on a scale of one to ten. A.L. also signed an A1A Health & Wellness Clinic Patient Informed Consent and Notice of Material Risks for Treatment of Intractable Pain with Controlled Substances on April 10, 2007, in which A.L. confirmed that Dr. Christensen had recommended and A.L. had requested treatment with opioid pain medication. By signing the form, A.L. also confirmed that he and Dr. Christensen had discussed alternative therapies, including drug cessation treatment using Suboxone and potential side effects and risks of controlled substances. At A.L.'s next office visit, on May 7, 2007, Dr. Christensen prescribed 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day and 60 2- milligram tablets of Xanax, with instructions to take one tablet two times per day. Dr. Christensen decreased A.L.'s prescription for Roxicodone from 300 30-milligram tablets to 240 30-milligram tablets, with instructions to take one tablet eight times per day. Dr. Christensen also noted in his typewritten notes that A.L. refused physical therapy and that Suboxone/Subutex was discussed with A.L. but that A.L. indicated that he was "not at all interested." At A.L.'s June 2, 2007, office visit, Dr. Christensen further reduced to 210 the number of 30-milligram Roxicodone tablets he prescribed for A.L., and he instructed A.L. to take one tablet seven times per day. Dr. Christensen noted in the Follow Up Visit form that he completed on June 2, 2007, that A.L. was not happy about the decrease in the number of Roxicodone tablets and complained that he would be in pain. Dr. Christensen noted that he explained again that the goal was to get A.L. drug-free. Dr. Christensen also discussed additional knee surgery as an option, but he noted that A.L. emphatically refused further surgery. Dr. Christensen included on the Follow Up Visit form for the June 2, 2007, office visit a notation that states in part that A.L. brought with him a "Drug Class II w/o Script (it was meds prescribed by in wrong bottle.)." There is no further explanation or mention of this in either Dr. Christensen's handwritten notes or typewritten notes for the June 2, 2007, office visit. A.L.'s final office visit to Dr. Christensen was on June 29, 2007. Dr. Christensen noted on the Follow Up Visit form that A.L. complained of knee pain that was "unbearable" at times. Dr. Christensen also noted that A.L. was experiencing increased lower back pain because he was walking with a limp. Dr. Christensen again decreased to 180 the number of 30-milligram Roxicodone tablets he prescribed for A.L., with one tablet to be taken every six hours. Dr. Christensen noted: "Patient will be underdosed but it was explain [sic] the importance of ? Roxi More H2O, reviewed [pain management] contract & goals of ? meds over time." According to the notes on the Follow Up Visit form, Dr. Christensen intended to let A.L. stabilize at 180 30-milligram Roxicodone tablets per month and to talk with A.L. again about beginning Suboxone. Dr. Christensen believed that the amount of medications that A.L. claimed to be taking at the first office visit on February 12, 2007, was clearly excessive, but he believed that A.L. was telling the truth. Although doubts about A.L.'s truthfulness regarding his medications crossed Dr. Christensen's mind, he chose to believe A.L. was telling the truth for several reasons. First, Dr. Christensen believed that a physician must assume that a patient is telling the truth, especially a complex patient like A.L., unless there is an objective reason for doubting the patient's veracity. Second, Dr. Christensen considered A.L. to be a model patient; he was clean, polite, fully alert, and competent. In addition, A.L. continued to keep his appointments with Dr. Christensen even though Dr. Christensen was decreasing the amount of Roxicodone he prescribed for A.L. each month. Third, Dr. Christensen was aware from his physical examinations of A.L. and from A.L.'s medical history that A.L. had long-standing problems with his knee that caused him pain. A.L. reported that he had been on pain medication for approximately ten years, and, even though Dr. Christensen thought the amount of medications A.L. reported he was taking at his first office visit with Dr. Christensen on February 12, 2007, was excessive, Dr. Christensen thought that A.L. could conceivably be taking the amount of pain medications he reported because, over time, A.L. probably had built up a tolerance for the pain medications and needed to take more of the medication. Dr. Christensen was concerned about the amount of pain medication A.L. reportedly was taking, however, and, therefore, one of Dr. Christensen's goals for A.L.'s treatment was to reduce the amount of pain medications A.L. was taking and, eventually, to wean him off of pain medications entirely. Fourth, an incident occurred early in his relationship with A.L. that made Dr. Christensen doubt A.L.'s veracity, but this assessment was proven wrong. Shortly after his first office visit on February 12, 2007, A.L. returned to Dr. Christensen's office and asked for a replacement prescription for Roxicodone, explaining that the prescription was in the pocket of his jeans and that the prescription had been damaged when his mother washed the jeans. Dr. Christensen thought that A.L. was simply seeking an additional amount of the pain medication. Dr. Christensen told A.L. he would have to bring in the damaged prescription, but Dr. Christensen doubted that he would do so. A.L. brought in the prescription, which had obviously been damaged, and Dr. Christensen felt badly because he had misjudged A.L. He taped the damaged prescription in A.L.'s medical file to remind himself that he should not prejudge his patients. Even though A.L. had consented to urine drug tests in the Pain Management Agreement he signed on February 12, 2007, Dr. Christensen did not order A.L. to submit to a urine toxicology screening test on his initial office visit, as a condition of Dr. Christensen's taking him on as a patient, nor did Dr. Christensen order A.L. to submit to a random urine toxicology screening test during the time A.L. was Dr. Christensen's patient. Given the extremely large amount of pain medications A.L. reported to Dr. Christensen that he had been taking prior to his first office visit on February 12, 2007, and Dr. Christensen's concern that A.L. was overmedicated, Dr. Christensen should have considered asking A.L. to submit to a urine toxicology screening test as provided in the Pain Management Agreement. Even if Dr. Christensen had administered one or more urine toxicology screening tests to A.L., however, the results of the test would have revealed only the types of drugs in A.L.'s system; that is, the urine toxicology screening test could have confirmed that A.L. was taking the medications that he reported to Dr. Christensen on February 12, 2007, and would have identified any illicit drugs he was taking at the time of the test; it would not, however, have provided any information on the quantities of drugs in A.L.'s system and, therefore, would not have confirmed the quantities of drugs A.L. reported to Dr. Christensen that he was taking at the time of his first office visit. Summary and findings of ultimate fact A few words of explanation are necessary before proceeding with the analysis of the evidence in this case. Given A.L.'s tragic death in July 2007, it is difficult for all concerned in this case to restrict their analysis of the evidence to those facts of which Dr. Christensen was aware during the time he treated A.L., yet it is essential that the evidence be viewed from this perspective. It became apparent during the course of this hearing that A.L. did not disclose certain matters to Dr. Christensen that might have changed the course of Dr. Christensen's treatment of A.L. These matters are irrelevant to the issues presented in the Department's Administrative Complaint; they are not part of the record in this case; and they have not, therefore, been considered in the preparation of this Recommended Order. Counts One and Three through Eight The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen prescribed Roxicodone, Methadone, or Xanax for A.L. inappropriately or in excessive amounts or that he breached the standard of care in prescribing these medications. The Department's expert witness testified that Dr. Christensen violated the standard of care because the combination, quantities, and dosages of the medications Dr. Christensen prescribed for A.L. were excessive. The Department's expert witness did not, however, identify the standard of care that would have governed Dr. Christensen's treatment of A.L., nor did he provide a clear explanation of the basis for his opinion that the combination, quantities, and dosages of medications Dr. Christensen prescribed for A.L. were excessive, especially considering the combination, quantities, and dosages of medications that A.L. reported to Dr. Christensen that he was taking at the time of his first office visit with Dr. Christensen. Rather, the Department's expert witness repeatedly stated his opinion, based on "his knowledge of pharmacology and more than 20 years['] experience,"5 that the prescriptions written by Dr. Christensen, if taken by A.L. as directed, would be "100 percent lethal, 100 percent of the time."6 The Department's expert witness gave no cogent explanation for his opinion that the combination, quantities, and dosages of the drugs would be 100 percent lethal, 100 percent of the time,7 which opinion, in any event, is refuted by the fact that A.L. was successfully treated by Dr. Christensen with the same combination of drugs, albeit with decreasing quantities of Roxicodone, for a period of four and one-half months.8 In addition, in formulating his opinion that the quantities and dosages of the medications Dr. Christensen prescribed for A.L. were excessive, the Department's expert witness apparently did not consider the possibility that A.L. had, over the years, developed a tolerance for these medications.9 In fact, the Department's expert witness did not give credence to A.L.'s complaints of pain; he did not believe that A.L. should have been treated with narcotics for pain; and it can reasonably be inferred from his testimony that the Department's expert witness would have refused to treat A.L. The Department's expert witness dismissed A.L.'s complaints of pain as not credible, stating that "[t]he patient is extremely young to have any pain complaints."10 The Department's expert witness testified that, if he had been consulted, he "would have recommended a trial of spinal cord stimulation"; that Dr. Christensen could have "prescribe[d] an appropriate brace for the knee"; or that Dr. Christensen might have chosen "to then make a referral to an orthopedic surgeon" for surgery on A.L.'s knee.11 The testimony of the Department's expert witness as to the treatment he would have provided to A.L. was repeatedly conditioned by the word "if"; if A.L.'s reported knee problem were confirmed, and if the Department's expert witness had agreed to treat A.L. In fact, on the basis of the written medical records alone, the Department's expert witness dismissed A.L. as "a liar and probably a substance abuser and certainly diverting his medication" and labeled as "outlandish" A.L.'s "self reported history of medication and prescription" and his "claims of being prescribed high dosages and lethal quantities" of controlled substances.12 In rendering his opinion that the combination, quantities, and dosages of the medications Dr. Christensen prescribed for A.L. were excessive and in violation of the standard of care, the Department's expert witness did not acknowledge in his testimony that Dr. Christensen considered the quantities, dosages, and number of different pain medications that A.L. reported on his first office visit to be excessive; that Dr. Christensen concluded that A.L. was overmedicated; that Dr. Christensen's treatment plan focused on decreasing the quantity of medications prescribed for A.L.; that Dr. Christensen did, in fact, refuse to write A.L. prescriptions for Oxycodone and Oxifast; that, at A.L.'s first office visit, Dr. Christensen wrote prescriptions for Roxicodone and Methadone for A.L. that were for quantities substantially smaller than those A.L. reportedly was taking; that Dr. Christensen assumed that A.L. was truthful when he reported that he was taking 60 to 90 two-milligram Xanax; that Dr. Christensen could not eliminate Xanax from the prescriptions he wrote for A.L. because abrupt withdrawal from Xanax could cause death; that Dr. Christensen reduced by one-third the number of two-milligram Xanax he prescribed for A.L.; that Dr. Christensen introduced at A.L.'s first office visit the possibility of A.L.'s using Suboxone to help in weaning him off of opioid analgesics such as Roxicodone and Methadone; that Dr. Christensen steadily decreased the quantity of Roxicodone he prescribed for A.L., until the amount was substantially less than the amount A.L. reportedly was taking at the time of his first office visit with Dr. Christensen. By failing to indicate that he considered these factors in rendering his opinions and by making the broad and unsupported assertion that the medications prescribed by Dr. Christensen for A.L. were 100 percent lethal, 100 percent of the time, the Department's expert witness substantially diminished the credibility of his opinions. Rather than taking an objective view of the treatment that Dr. Christensen provided A.L. from February 12, 2007, to June 29, 2007, the Department's expert witness demonstrated throughout his testimony a disdain for Dr. Christensen as a physician. This disdain for Dr. Christensen is made particularly clear when the Department's expert witness attributed to Dr. Christensen a purely economic motive in his treatment of A.L. The Department's expert witness testified that Dr. Christensen, in common with "most pill mills or physicians like the subject," had "a huge economic incentive" for his treatment of A.L.13 These statements demonstrated a bias against Dr. Christensen that substantially diminished the credibility of his testimony, in general, for the following reasons. First, there was no allegation in the Administrative Complaint and no evidence in this record to support the categorization of Dr. Christensen by the Department's expert witness as a physician associated with a "pill mill." Second, in reaching his conclusion that Dr. Christensen's motivation for treating A.L. was purely financial, the Department's expert witness assumed, in the absence of even a scintilla of evidence in this record, that Dr. Christensen required his patients to pay a substantial amount of cash for each office visit and that Dr. Christensen was a "dispensing physician," that is, a physician who sells drugs as well as prescribing them.14 Count Two In Count Two of the Administrative Complaint, the Department charged Dr. Christensen with violating the standard of care in four respects, which are discussed in detail below. Failure to diagnose a history of anxiety The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to diagnose a history of anxiety to support prescribing Alprazolam."15 Dr. Christensen noted on the New Patient History Form completed during A.L.'s first office visit on February 12, 2007, that A.L. reported a history of anxiety as a psychiatric condition, and A.L. also reported that he was currently taking Alprazolam, or Xanax. On each of A.L.'s subsequent office visits to Dr. Christensen, A.L. reported on the Pain Outcomes Profile that he had significant feelings of anxiety, and Dr. Christensen observed that A.L. exhibited anxious behaviors during his office visits. The Department's expert witness apparently overlooked this information in Dr. Christensen's medical records because he testified that he could find no justification for prescribing Alprazolam for A.L.16 Failure to order urine toxicology screening test The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to order screening urine toxicology to rule out usage of illicit substances or confirm usage of prescribed medications." The Department's expert witness identified the standard of care at the times pertinent to this proceeding as requiring patients to submit to intermittent urine toxicology screening studies so that the patient wouldn't know when such testing would take place. The Department's expert witness further explained that it was always a matter of clinical judgment as to when to require a patient to submit to a urine toxicology screening study, even to a patient such as A.L., who had reported taking a large quantity of pain medications at the time of his first office visit to Dr. Christensen. The Department's expert witness testified that, given the amount of pain medications A.L. reported to Dr. Christensen that he was taking at the time of A.L.'s first office visit, a urine toxicology screening study of A.L. at the first office visit would be "indicated," but the Department's expert witness did not testify that Dr. Christensen violated the standard of care by failing to require A.L. to submit to such a study at that first office visit or during the time he was treating A.L. In fact, according to Dr. Christensen's expert witness, at the times pertinent to this proceeding, it would not be within the standard of care to require a patient to submit to a urine toxicology screening study within the first four and one-half months of treatment.17 Finally, there is no indication in the record that Dr. Christensen had any reason to suspect that A.L. was taking illicit substances; the primary concern Dr. Christensen, and the Department's expert witness, had with respect to A.L. was the quantity of pain medications he was reportedly taking at the time of his first office visit. Because a urine toxicology screening study reveals only the types of substances in the urine and not the quantity of such substances, a urine toxicology screening study would not have revealed whether A.L. was lying about the quantities of pain medications he reported to Dr. Christensen on his first office visit, as was concluded by the Department's expert witness; such a study would have revealed only whether A.L. was, in fact, taking these substances, a concern that, based on the information available to him, Dr. Christensen did not have at A.L.'s first or subsequent office visits. According to the standard of care identified by the Department's expert witness, Dr. Christensen did not deviate from this standard of care by using his clinical judgment to decide not to require A.L. to submit to a urine toxicology screening study. Failing to refer A.L. for treatment for substance abuse The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to refer Patient A.L. to a psychiatrist and/or addiction specialist and/or rehabilitation center for substance abuse." The only mention of Dr. Christensen's failure to refer A.L. to a psychiatrist, addiction specialist, or rehabilitation center in the testimony of the Department's expert witness was in answer to the question of the Department's counsel: "Would respondent's failure to do so in this case fall below the standard of care?" The Department's expert witness answered: "Given his [A.L.'s] claims of previous medication prescription and usage, yes."18 The Department's expert witness never defined the standard of care to which he was referring, and his opinion, therefore, is not persuasive on this issue.19 Failure to order diagnostic tests The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to order diagnostic tests to justify the course of treatment for patient A.L." The Department's expert witness testified that he would "not be prepared to say that [Dr. Christensen's failure to order a diagnostic test to justify his course of treatment for A.L. fell below the standard of care] because there's no justification for the course of treatment regardless of any study or consultation that the subject could have initiated."20 There was no allegation in the Administrative Complaint that Dr. Christensen violated the standard of care because there was no justification for the treatment he provided A.L., and this testimony is irrelevant to a determination of whether Dr. Christensen should have ordered additional diagnostic tests for A.L. The Department's expert witness did, however, go on to state that, under the circumstances of this case, "a reasonable and prudent physician . . . should have, at the very least, ordered an MRI study of the knee, [and] performed a comprehensive physical examination of the effected [sic] joint" and that "many physicians would have ordered an MRI of the knee or at the very least, perform [sic] a very detailed and well documented physical examination and then written down his treatment plan and the justification for his treatment plan."21 To the extent that this testimony constitutes the articulation of the standard of care by the Department's expert witness, the opinion of the Department's expert witness that Dr. Christensen fell below this standard of care is unsupportable for two reasons. First, the Department's expert witness incorrectly identified the report of the MRI of A.L.'s knee done in 1998 as the only MRI report in Dr. Christensen's medical records. The Department's expert witness overlooked the report in Dr. Christensen's medical records of the post-surgical MRI done of A.L.'s left knee on August 23, 2002, four and one-half years before A.L.'s first office visit to Dr. Christensen in February 2007. Therefore, the opinion of the Department's expert witness that Dr. Christensen fell below the standard of care for failing to order an MRI is not persuasive because it is based on the incorrect assumption that the most recent MRI of A.L.'s knee was done nine years prior to his first office visit with Dr. Christensen. Second, Dr. Christensen did a comprehensive physical examination of A.L.'s left knee joint. Dr. Christensen, aided by his background in chiropractic orthopedics, performed several tests on A.L.'s left knee, which, together with the post- operative MRI done in August 2002, led him to the conclusion that, if anything, the condition of A.L.'s left knee would not have improved, and probably would have worsened, over the intervening years. Dr. Christensen documented the results of the examination in the typed notes he prepared on February 12. 2007, and set out his diagnosis and treatment plan for A.L. Therefore, the opinion of the Department's expert witness that Dr. Christensen fell below the standard of care for failing to conduct a comprehensive physical examination of A.L.'s left knee and to document the results of the examination and the treatment plan for A.L. is unpersuasive because the Department's expert witness apparently overlooked this information in A.L.'s medical records.22

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint filed against John Christensen, M.D., by the Department of Health. DONE AND ENTERED this 28th day of June, 2011, in Tallahassee, Leon County, Florida. S Patricia M. Hart 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 28th day of June, 2011.

Florida Laws (8) 120.569120.57456.072456.50458.331766.102766.203893.03
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BOARD OF MEDICINE vs JOHN AUGUST ORTOLANI, 94-002116 (1994)
Division of Administrative Hearings, Florida Filed:Daytona Beach, Florida Apr. 20, 1994 Number: 94-002116 Latest Update: Jul. 16, 1996

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

Florida Laws (4) 120.57120.68458.331465.003
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