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.
The Issue The issue in this case is whether the Petitioner is entitled to a passing grade on the November, 1987, Chiropractic (Proprietary Drug) licensure examination. The Petitioner challenged two questions on that examination, but at the hearing presented evidence regarding only one of the challenged questions, namely, question 29. The Petitioner testified on his own behalf, but did not call any other witnesses. The Petitioner also presented copies of pages from several published reference books. The parties stipulated that official recognition of those pages could be taken. The Petitioner also offered other documents which were rejected as exhibits and are not included in the record. The Respondent presented the testimony of one witness, an expert in the fields of pharmacy and pharmacology. The Respondent also offered several exhibits which were received in evidence. Following the hearing, the parties were allowed until January 9, 1989, within which to file their proposed recommended orders. The Petitioner filed a timely proposed recommended order, the factual aspects of which are addressed in the appendix to this recommended order. The Respondent did not file a proposed recommended order.
Findings Of Fact Based on the proceedings at the formal hearing in this case, I make the following findings of fact. In November of 1987, the Petitioner took the chiropractic licensure examination. The Petitioner has been assigned a score of 73.3 on the proprietary drug portion of that examination. A score of 75 is the minimum passing score on the proprietary drug portion of the examination. If the Petitioner is given credit for one additional question, he will be entitled to a passing score on the subject portion of the examination. The Petitioner was not given credit for his answer choice on question number 29. He chose answer B. The Respondent contends that the only correct answer choice is answer A. The issue of whether the Petitioner is entitled to credit for his answer choice on question number 29 turns on whether use of an inhalant containing epinephrine is seriously contraindicated by both of the following conditions: angina pectoris and pregnancy. The use of such an inhalant is seriously contraindicated by the condition of angina pectoris. Epinephrine should never be administered to a patient who suffers from angina pectoris. The use of such an inhalant is not seriously contraindicated by the condition of pregnancy. An epinephrine based inhalant should be used with caution during pregnancy, but the condition of pregnancy does not contraindicate the use of such an inhalant. The Petitioner's choice of answer B is an incorrect choice, because the condition of pregnancy does not seriously contraindicate the use of a inhalant containing epinephrine. Therefore, the Petitioner is not entitled to credit for his answer to question number 29.
Recommendation Based on all of the foregoing, it is recommended that a final order be issued assigning to the Petitioner a final grade of 73.3 and concluding that the Petitioner has failed the subject examination. DONE AND ENTERED this 18th day of January, 1989, at Tallahassee, Florida. MICHAEL M. PARRISH Hearing Officer Division of Administrative Hearings The Oakland Building 2900 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of January, 1989. APPENDIX TO RECOMMENDED ORDER, CASE NO. 88-4011 The following are my specific rulings on all proposed findings of fact submitted by all of the parties. Findings proposed by Petitioner: The Petitioner's proposed recommended order consists of four unnumbered paragraphs, each of which is more in the nature of argument than in the nature of proposed findings of fact. Nevertheless, to the extent those paragraphs assert or imply factual matters, they are addressed as follows: First Paragraph: Rejected as contrary to the greater weight of the evidence. Second Paragraph: Rejected as contrary to the greater weight of the evidence. Angina pectoris is the only correct answer. Third Paragraph: Rejected as contrary to the greater weight of the evidence. Fourth Paragraph: Rejected as constituting a conclusion which is contrary to the greater weight of the evidence. Findings proposed by Respondent: (No findings were proposed by Respondent.) COPIES FURNISHED: James E. Marino, D.C., pro se 210 South Street Daytona Beach, Florida 32014 William A. Leffler, III, Esquire Staff Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Pat Guilford, Executive Director Board of Chiropractic Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Kenneth Easley, General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
Findings Of Fact The Respondent, Solomon D. Klotz, M.D., at all times pertinent hereto, has held a current, valid medical license number ME 0002269, issued by the Board of Medical Examiners, Department of Professional Regulation, which is the agency charged with enforcing Chapter 458, the "Medical Practice Act," as it relates to qualification for licensure and standards for regulating medical practice of physicians licensed in the State of Florida. The Respondent is also board- certified by the American Board of Internal Medicine in internal medicine and is board- certified in the field of allergy and immunology by the American Board of Allergy and Immunology. The Respondent obtained his M.D. Degree from New York Medical College in 1937, obtaining a Masters from that institution in 1942. He was licensed in New York in 1938 and was made a diplomate of the National Board of Medical Examiners in 1938. He was issued his Florida license in 1941. He served in the Medical Corps of the United States Army in World War II and during the years 1945 and 1946 was a clinical instructor at New York Medical College, and a research fellow at Metropolitan Hospital Research Unit in New York. The Respondent has practiced in his specialty field of internal medicine as well as allergy and immunology in Florida for many years. He is presently a clinical professor at the College of Health of the University of Central Florida, and an adjunct professor at the Department of Biological Sciences at the University of Central Florida. Respondent is presently on the medical staffs at Winter Park Memorial Hospital, Florida Hospital, Orlando Regional Medical Center and Humana Hospital/Lucerne, with a senior consultant rating at each of the above hospitals. The Respondent is a member of 21 professional societies and was a founding member of the Salk Institute for Biological Studies and, the board of the Joint Council of Allergy and Immunology. He has served as president of the American College of Allergists, the Florida Allergy Society, Southeastern Allergy Society, and is president of the medical staff of Florida Hospital in Orlando. The Respondent has published or presented more than 50 research papers, seven of which have been published within the past three years in such journals as the Annals of Allergy, the Journal of the Florida Medical Association, the Journal of the American Academy of Allergy and Immunology and the American Heart Journal. Concerning the disease or condition most pertinent to the charges in the administrative complaint, the Respondent published a paper jointly with Dr. Von Hilsheimer in 1970 concerning minimal brain dysfunction, attention disorders and the diagnosis of functional narcolepsy. Dr. George Von Hilsheimer was accepted as Respondent's expert witness concerning the diagnosis of narcolepsy and the various forms or manifestations of narcolepsy and the treatment thereof. He is a licensed psychologist in the State of Florida, having been educated at the University of Miami with postgraduate work at the University of Chicago. He interned in psychology at the Corsack Clinic and the Seabrook Institute in San Francisco. He completed his Ph.D. in psychology with a multiple major in neuropsychology, psychoimmunology and psychotherapy. He is an associate fellow in the Society for Clinical Ecology, a consultant to the Science Advisory Committee of the Environmental Protection Agency as a neuropsychologist and behavioral toxochologist. He is eligible for board certification by the Academy for Psychosomatic Medicine and the American Academy of Behavioral Medicine. He has published numerous reference papers and a number of books, one of which books focused on the diagnosis of minimal brain dysfunction and the issue of psychosomatic versus somatic causes for behavior. He has presented two papers in conjunction with the Respondent on the issue of minimal brain dysfunction, tension disorders and the diagnosis of functional narcolepsy. Since 1980, Dr. Von Hilsheimer's practice has been split between psychotherapy and psychoimmunology. In the past ten years he has presented numerous continuing education workshops for physicians, which courses were certified by the American Medical Association. Dr. Dale K. Lindberg, M.D., was accepted as an expert witness for the Petitioner regarding the pharmacological effects, uses and indications of the drugs related to the charges in the administrative complaint. Dr. Lindberg has been a licensed physician in the State of Florida since 1959. He is board certified in nuclear medicine. He took a residency in nuclear medicine at Mt. Sinai Hospital in Miami Beach between the years 1974 and 1977. Since 1973, his practice has been limited to primarily that of supervising methadone maintenance programs and clinics. Prior to 1973 his practice was in the area of family practice, as well as nuclear medicine. He is a member of the Broward County Medical Association, Florida Medical Association, American Medical Association, Broward County Family Practice Association, as well as the Society of Nuclear Medicine. Dr. Lindberg has never treated a patient with narcolepsy nor has he seen patients exhibiting the various kinds of narcoleptic behavior. METHAQUALONE PRESCRIPTIONS; COUNTS I, II AND III The first three counts in the administrative complaint concern prescriptions written June 24, 1982, for allegedly excessive and unjustified amounts of a controlled substance, methaqualone, prescribed to patients Harri Klotz (Count I) , Sam Meiner (Count II) and Charles Meiner (Count III). Those prescriptions consisted of 121 sopor (150 mgs) for Harri Klotz; 189 parest for Sam Meiner; and 34 quaaludes for Charles Meiner, all of which are methaqualone medications. The Respondent received a telephone call on or shortly before June 24, 1982, the date the prescriptions were written, from a pharmacist whom he regularly dealt with, who informed him that, inasmuch as, effective July 1, 1982, he would be unable to fill methaqualone prescriptions due to a change in the law by which it became a Schedule I drug, that he would make available the small quantity of methaqualone remaining in stock to the Respondent for his patients who required the drug. The Respondent acknowledged having a few such patients and accordingly wrote prescriptions for the above odd numbers of capsules to patients whom had been regularly receiving methaqualone medication for a period of time previously. Patient Harri Klotz is the Respondent's wife. She has been a patient of Respondent since approximately 1940. She suffers from generalized osteo- arthritis involving mainly the hips, which was first diagnosed in 1967. Due to progressive severity of the disease she received surgery in October, 1970, in Germany, for replacement of both hip joints with artificial prosthesis. Since that time the right hip prosthesis joint cracked, causing her severe, chronic pain which caused her great difficulty in sleeping. After taking numerous combinations of medicine, Mrs. Klotz was found to respond most effectively to methaqualone, which induced sleep in spite of the pain, without undesirable side effects the next morning. She ultimately had the right hip prosthesis repaired. Her medical records indicate that this medication had also been prescribed for her by her treating physicians when the prosthetic devices were implanted. In 1981 she again began experiencing the same type of agonizing, chronic pain in her left hip and consulted an orthopedic surgeon at regular intervals concerning it. It was not until November, 1952, however, that the diagnosis was made that her left prosthesis had also broken. During the various attempts to diagnose the cause of this problem with her left hip, she was experiencing severe, chronic pain. Finally, after a third stint of surgery the left hip prosthesis was replaced and her symptoms ultimately improved. In the meantime however, on October 14, 1981, Respondent purchased 1,000 quaaludes for his wife. He did not dispense the entire lot to her, rather she was given 30 capsules at a time for use in inducing sleep during the period when she suffered from her painful condition at intervals of one and one-half to two months. The Respondent carefully monitored her dosage and kept the balance under lock and key at his office, duly recording on a dispensing record the capsules actually given to his wife on each occasion. On June 24, 1982, before methaqualone became a Schedule I Controlled Substance, he last prescribed that substance for his wife when he wrote the prescription for 121 sopor. He has not since prescribed a methaqualone substance to his wife. On June 24, 1982, the Respondent prescribed methaqualone to Sam Meiner. Mr. Meiner (Respondent's counsel) has been a patient of the Respondent since approximately 1968. Be suffers from a severe, chronic painful condition called regional enteritis, a condition characterized by severe, chronic pain and acute bowel spasms associated with acute exacerbations of the enteritis condition. As a result of this condition he has had two bowel resection surgeries, during the course of which surgeons removed approximately six feet of his small intestine. He has suffered from this disease chronically for approximately 18 years, having his first surgery in 1967 and the second in 1977. "hen the enteritis condition became acutely inflamed after his second surgery, he once again sought Respondent's medical advice. He has been a continuous patient of the Respondent ever since that time, seeing him almost on a weekly basis. Included in the total medical care Respondent has given this patient is a prescription of methaqualone for its beneficial soporific and antispasmodic effects designed to curtail the severity and duration of the bowel spasm incidents. Other physicians, as well as Respondent, in treating this patient have attempted many other combinations of medications before the Respondent and patient determined that methaqualone was the most effective modality. Since being under the Respondent's care with attendant methaqualone medication, the patient has required no hospitalization and has been able to lead a substantially normal existence, even though this disease or condition if unsuccessfully treated can ultimately prove fatal, especially if additional such surgical procedures are resorted to. Witness Meiner was shown to have no abnormal adverse effects nor physical or psychological dependence on the drug. It is now no longer legally obtainable, the patient being afforded his last prescription therefor on June 24, 1982, some six days before the prescription of the drug became illegal. On June 24, 1982, the Respondent prescribed 34 methaqualone capsules to Charles Meiner. Charles Meiner (also counsel for Respondent) suffers from a chronic, severe back injury involving a ruptured or degenerative disc. He periodically suffers excruciating, chronic back pain, resulting in his inability to sleep. He has been a patient of the Respondent since 1969. In 1973 he required hospitalization due to the severity of the back pain. lie has seen the Respondent for this problem at regular intervals ever since. He had been prescribed methaqualone on a number of occasions prior to June, 1982, as the medication helps his insomnia resulting from the chronic back pain, without imposing any adverse effect the following morning or inhibiting his ability to function in the legal profession. Be has never taken more than one tablet per day and some days only a half tablet during the course of his back pain flare- ups. In May of 1982, his back condition became particularly severe, with persistent pain. Because of this exacerbation of his back condition, he was given a prescription for 34 quaalude tablets on June 24, 1982, to relieve his pain and enable him to sleep. During the time Respondent prescribed methaqualone to these three above-named patients, methaqualone was an acceptable medication for relief of the symptoms these patients exhibited. Petitioner's witness Dr. Lindberg acknowledged that the prescribing of methaqualone by the Respondent to these patients on or before July 1, 1982, was for a medically justifiable purpose, and that the dosages involved were within recommended daily dosages for the treatment of the symptoms exhibited by these patients, as depicted in the Physician's Desk Reference (PDR) a work relied on by both parties throughout this proceeding. AMPHETAMINE PRESCIPTIONS: COUNTS IV, V, VII, XI, XII, XIII, XIV, XVI, XVII, XVIII and XIX. The prescription of amphetamines became restricted as to use by the enactment of Section 458.331(1)(cc) , Florida Statutes, effective August 30, 1980. This restricted the prescription of any drug which is an amphetamine or a sympathomimetic amine drug (a Schedule II drug) except, as pertinent here, for the condition of narcolepsy. Prior to the restriction of the drug, the Respondent had prescribed such drugs for short-term use for patients who were attempting to embark on a successful weight-control program. The Petitioner's expert witness, Dr. Lindberg, acknowledged that this was a medically appropriate use of this type of medication at the time and that he himself had made similar prescriptions for similar purposes. The Respondent conceded that as of July 3, 1980, that he was not aware of the change in the legal status of amphetamine type drugs by the enactment of the above statute, and did not become aware of such restrictions until the pharmacist with whom he regularly dealt informed him that he could not prescribe Biphetamine, Dexedrine or other sympathomimetics unless the patient had a narcoleptic condition. Upon becoming aware of this restriction after August 30,1980, the Respondent discontinued use of those drugs except for the treatment of narcoleptic symptoms in patients. Dr. Lindberg opined that the only type of narcolepsy he would recognize was "ideopathic narcolepsy." By this he meant that he would only diagnose narcolepsy when all four recognized symptoms are present: excessive daytime sleepiness, cataplexy (a condition when muscles become limp) , hypnogogic hallucinations (dreams shortly before going to sleep or upon awakening) and sleep paralysis whereby the patient is unable to move, although the limbs are not rigid. Dr. Lindberg has never treated a patient with narcolepsy nor has he ever observed a patient exhibit narcoleptic behavior in his practice. Both the Respondent and Dr. Von Hilsheimer, the Respondent's expert witness on the subject, have studied and treated this condition and published recognized research papers on the subject of narcolepsy. Further, the Respondent in connection with his speciality in the field of allergies, has performed testing regarding patients with certain food sensitivities and has observed that some of them will exhibit narcoleptic symptoms as a reaction to certain foods. Dr. Von Hilsheimer, as delineated above, has extensive experience in the diagnosis and treatment of narcolepsy in its various forms and in teaching recognition of the condition to doctors through continuing education courses. Idiopathic narcolepsy, the extreme or classic view of the disease, may involve exhibition of all four of the above symptoms in a patient, however, only 10 percent of patients legitimately diagnosed as narcoleptic present all four symptoms, and therefore most of the scientific and medical community uses the term "narcolepsy" In a broader, more general sense to mean essentially excessive, inappropriate daytime sleepiness, especially at inappropriate times. In addition to narcolepsy being a primary affliction, it can also be a subsyndrome, or secondary disorder related to a different medical problem. It can be permanent or can be a transient condition and can be a by-product of unusual psychological or physical stress. The Respondent prescribed a small dosage of an amphetamine for Nina Balabon between January 11, 1980, and September 17, 1982, at various times. (Count IV) Ms. Balabon is a 92 year old woman who has been taking a very small dosage of Dexedrine for many years. The dosage is substantially below that allowable for such a patient as conceded by the Petitioner and delineated in the Physician's Desk Reference. Ms. Balabon lives alone in Woodstock, New York, and is the foster mother of the Respondent's wife. She had been under the care of another physician who prescribed this course of treatment and drug for her so that she could remain alert enough to independently function and take care of herself in her own home. She is home-bound and after her doctor's death, she was unable to secure another doctor who would make house calls. She called upon the Respondent who is, in effect, a family member, and financially supports her, and asked him to prescribe the medication for her, in conjunction with which she retained the services of a visiting nurse. In her old age she has become afflicted with lassitude, inappropriate and excessive daytime sleepiness, depression and a diminished "will to live." The Respondent visits her in Woodstock, New York, periodically and he or his wife, telephone her at least once a week. A visiting nurse checks on her condition weekly and reports to the Respondent on her physical condition. The Petitioner's expert witness, Dr. Lindberg, has never seen this patient, but surmised upon her recorded weight that she is slightly malnourished. Accordingly, he opines that it is inappropriate to give a person with such a condition (slight malnourishment) amphetamines to curb her appetite and provide her "pep." The Respondent, however, did not prescribe amphetamine for this purpose. Be found, in the exercise of his medical judgment that she exhibits definite symptoms of narcolepsy. The dosage is extremely small and the patient is not shown to suffer any adverse effects therefrom. It was not shown that the dosage curbed her appetite, and indeed, Respondent established that the patient is not malnourished. She is a very small, slightly built woman and her mere recorded weight is not an indication in itself of malnourishment such that the prescription involved would be contraindicated. Petitioner's expert witness, further was unaware that the patient exhibited symptoms of narcoleptic behavior, and admitted that otherwise the dosages were quite small and not excessive for such a patient. Dr. Lindberg merely opposed the prescription of the medication because he believed that the law changed regarding the use of this drug, such that after August 30, 1980, it is only permissible for narcoleptic symptoms. In any event, the Respondent's diagnosis of the patient was uncontradicted and the 92 year old patient was shown to benefit from this treatment of her condition because it permitted her, with the assistance of the visiting nurse, to continue living independently rather than suffering commission to a nursing home or other institutional facility. Count VII concerns alleged prescriptions of amphetamines to one Doris Calloway between February 16, 1982 and October 13, 1982. Petitioner failed to introduce any evidence or testimony concerning this count. With regard to Count XI, Respondent prescribed on only one occasion, 50 Biphetamine capsules for Lori Carroccia on September 29, 1980. At the time this prescription was written and issued, the Respondent was unaware of the recent restrictions imposed by the legislature on the purposes for which amphetamine-type drugs could be prescribed by the passage of Section 458.331(1)(cc), Florida Statutes, effective July 1, 1980. The Respondent had known this patient for approximately six years and she was his nurse, employed at his clinic at the time the prescription was written. The single prescription was written when she complained to him of difficulty in starting a weight loss program and asked for his assistance. Prior to writing the prescription, he checked Ms. Carroccia's physical health, checked her weight and blood pressure, and indeed was already aware of her medical history because of his close association with her. During the entire two months she received this medication Respondent saw her on a daily basis and monitored her progress. The medication proved to be an effective means for her to develop a successful weight loss program. She suffered no adverse effects from receiving this drug. The Respondent only prescribed this medication once, in a small dosage to Initiate her weight loss program and not for the purposes of maintaining weight loss or a particular weight level through long-term prescriptions. Petitioner's sole expert witness conceded that the dosages were not excessive and were medically indicated in the PDR for the initiation of such a weight loss program. Petitioner's expert witness admitted that his opinion regarding inappropriateness of the prescription was solely predicated on the change in the legal status of the drug. The Respondent prescribed an amphetamine medication to patient Evelyn Lilly between April 14, 1981 and December 19, 1981 (Count XII). Ms. Lilly had been his patient since 1979 for allergy evaluation and treatment to alleviate chronic symptoms of runny nose, throat infections and irritations and sinus headaches. Respondent gave her an allergic evaluation in response to these symptoms. In completing her patient history he noted that Ms. Lilly suffers from rheumatism and arthritis. During the course of her allergy treatments Ms. Lilly's weight began increasing dramatically, with a worsening of her arthritic condition. Respondent noted she was markedly fatigued and became concerned about her general physical condition. In response to her fatigue or lassitude complaints, he initially performed a thyroid test in an effort to determine the cause of her lassitude and rapid weight gain. That test was inconclusive. lie then decided that between the complications of arthritis and her allergies he must reduce her weight before he could successfully treat either of those conditions. He initially prescribed Tenuate Dosepan which proved ineffective and then Ritalin, which also proved ineffective. She was then prescribed a course of Biphetamine. She responded dramatically to this medication with relief of her lassitude and the loss of 30 to 40 pounds. After noting that the initial sympathomimetic type drugs prescribed were ineffective and that the change to the Biphetamine produced markedly successful results, Respondent came to the conclusion that the patient was narcoleptic. Narcolepsy sometimes is not alleviated with the prescribing of one type of sympathomimetic drug when the switch to treatment with another type will suddenly prove to be successful in alleviating the narcoleptic symptoms. The doctor's chart for this patient did not definitely indicate the purpose of the prescription of the amphetamine medication, although Dr. Klotz candidly responded in his testimony that it may have been in part for weight control because a reduction in weight would help alleviate her arthritic joint problems. However, inasmuch as narcolepsy can be indicated when one type of sympathomimetic drug will not relieve its symptoms and another type will and since is. Lilly in her reaction to the medications displayed this phenomenon, Respondent, in the reasonable exercise of his medical judgment concluded that she displayed symptoms of narcolepsy. This view is corroborated by Dr. Von Hilsheimer. He has had more than 1,000 patients referred to him over the years by the Respondent. Approximately one-third of these patients were obese and yet he was only aware of four such patients who were treated with biphetamines by the Respondent. Be thus concludes that the Respondent used some differential reason other than mere weight control for prescribing biphetamine which led to the diagnosis of symptomatic narcolepsy with Ms. Lilly. The Petitioner's expert witness once again felt that the Biphetamine and Ritalin prescriptions for Ms. Lilly were inappropriate and excessive, but acknowledged that his criticism of these prescriptions was predicated solely on the fact that the medication had become illegal for prescription for weight control purposes before Ms. Lilly's prescriptions were made. Dr. Lindberg ultimately agreed however, after consulting the PDR that the amounts and types of medication were within appropriate indications, dosage limits and amounts and thus the amounts prescribed were within the reasonable exercise of the Respondent's judgment as a physician for the symptoms displayed, and alleviated them. Concerning this patient, as with all the others involved herein, Petitioner's expert witness bases his testimony merely on the doctor's patient chart which does not specifically refer to narcoleptic symptoms. Respondent admits his records are not detailed in all cases, since the patients were not referrals, but were his patients for many years such that he was intimately familiar with their histories and conditions. Based on the lack of reference to narcoleptic symptoms in the records themselves, Dr. Lindberg opined that the prescription was medically inappropriate, however, the mere absence of reference to that condition in the medical records alone does not establish the medical inappropriateness of the prescription, especially in view of the Respondent's showing (corroborated by Dr. Von Hilsheimer) that indeed Ms. Lilly was narcoleptic. Mr. Emmett Peter was prescribed biphetamines between October 16, 1979 and September 14, 1982 by the Respondent (Count XVI). Mr. peter has been Respondent's patient since 1969 and `gas definitely diagnosed as a narcoleptic individual by a physician who treated him prior to that time and related that fact in his initial medical history provided Respondent. At the time he and his wife became patients of the Respondent, Mr. Peter was receiving a medication called Obedrin, which is a dexedrine-type drug. During the entire time he received medication from the Respondent, he periodically visited the Respondent on his own behalf, as well as accompanying his wife to the Respondent's clinic for treatment, at which times the Respondent also observed Mr. Peter. Although the Respondent was unaware of the change in the law regarding restriction of the use of amphetamines to the treatment of narcolepsy at the time he prescribed Mr. Peter's medications at issue in this case, he continued to prescribe the medication for Mr. Peter after he became aware of the law, because he definitely diagnosed Mr. Peter to be a narcoleptic. The Respondent's expert witness, Dr. Von Hilsheimer, has seen both Mr. and Mrs. Peter on a professional basis as a researcher. He had numerous occasions to observe Mr. Peter, approximately twice a week from March, 1980 through May, 1982. Be became quickly aware of the fact that Mr. Peter was narcoleptic due to the fact that Mr. Peter, when waiting for his wife at Dr. Von Hilsheimer's office, often fell asleep in a very dramatic way, sometimes even when Dr. Von Hilsheimer was engaged in conversation with him. It was thus established that Mr. Peter, based upon his medical history and the personal observation of both Dr. Klotz and Dr. Von Hilsheimer, suffers from a minimal brain dysfunction manifested as excessive, inappropriate sleepiness. Dr. Von Hilsheimer further noted that Mr. Peter's condition is also characterized by moderate cataplexy, another symptom of narcolepsy. There is no question that Mr. Peter suffers from narcolepsy, therefore the prescription of amphetamine medications to Mr. Peter was clearly medically appropriate and the Petitioner admitted that the amounts of the medication were not excessive. On February 24, 1981, Charne D. Porter, the Respondent's daughter was given a prescription for 30 10-mg Ritalin tablets (Count XVII). The Respondent has been her treating physician most of her life. At the time the prescription was written she was editing and producing a motion picture. She was working very long hours and complained to Respondent that she was having difficulty staying awake during all times of the day and in completing her film-editing work. Prior to this period of time however, her typical work schedule involved such long hours with no apparent ill effects. This was not an unusual work schedule for her. Dr. Von Hilsheimer has known Ms. Porter since 1979 and she has consulted him professionally in the past. He was quite familiar with the patient history and had occasion to see her during the time the medication involved was prescribed. During this period of time he found that when she was attempting to do film-editing work which is normally a stimulating, arousing type of endeavor, she did not have her normal responsiveness and while talking to him would doze off in the middle of a conversation in his office. The work she was trying to do at the time was quite arousing under unusual conditions of lighting and interest and yet she would still doze off at inappropriate times during the day while working. The doctor did not find that her long work schedule or hours were responsible for such a condition. Ms. Porter had a debilitating illness consisting of the lingering aftereffects of a form of hepatitis and this, coupled with the stress related to her film-editing job (for which she was obtaining treatment through self-hypnosis training by Dr. Von Hilsheimer) caused her to lose her normal "arousal ability." Because of this she did have an attack or episode of transient narcolepsy as diagnosed by Respondent and Dr. Von Hilsheimer. During visits in his office he observed her display three of the four commonly recognized symptoms of narcolepsy during approximately the same period of time in which she received the Ritalin prescription. These inappropriate sleep episodes were a transient condition and Ms. Porter recovered from that condition and is functioning well personally and professionally. The small original Ritalin prescription needed no renewal. The use of the Ritalin prescription was a reasonable exercise of Respondent's medical judgment and approach to alleviating the transitory narcolepsy symptoms exhibited by Ms. Porter and caused her no harm whatever. Patient Sandy Lee Bradford was prescribed Biphetamine between December 14, 1980 and December 15, 1981. She is the daughter of the Respondent's secretary and has been the Respondent's patient for many years. On December 15, 1980, due to her complaint of fatigue, daytime sleepiness episodes, along with inability to lose weight and excessive weight gain, the Respondent first prescribed biphetamines to her. Over a one year period she subsequently received four other prescriptions of biphetamines. Each time she received a new prescription, she personally saw and consulted with Dr. Klotz. At the time the prescriptions were administered she had recently been divorced and was suffering unusual stress and emotional anxiety related to that divorce, which Respondent believed had a direct effect on her sudden weight gain and inability to lose weight. At the time the Respondent made these prescriptions, he was as yet unaware of the change in the legal status of amphetamine-type drugs such that it was no longer legally permissible to prescribe them for weight loss purposes. The Respondent candidly admitted that he primarily prescribed the drugs for assisting her in embarking on a successful weight loss program, not for chronic use. Other anorectic medications had been tried on this patient and had proved ineffective, however, with the judicious prescription and use of the biphetamine medication the patient made substantial progress in losing weight and in alleviating symptoms of fatigue. When Respondent became aware of the change in the legal status of biphetamines, he discontinued that medication promptly and substituted Tenuate Dosepan, which proved ineffective. He then substituted Ionamine which also proved ineffective, in an attempt to avoid prescribing biphetamines for the patient. The biphetamines prescribed were in appropriate, non-excessive quantities for the condition and symptoms exhibited by the patient and successfully alleviated her complaints with no harm to the patient. He discontinued biphetamines because he felt he could not with reasonable medical certainty, diagnose her as a narcoleptic patient. Dr. Lindberg conceded that the prescriptions were medically appropriate, but for the change in the law regarding their permissible use, and that change was the sole basis for his opinion that the prescription was inappropriate. Patient Trudy Heintz was prescribed Dexedrine between January 3, 1980 and October 29, 1982. She has been a patient of the Respondent since the early 1950's. She has displayed, over many years, symptoms of excessive, inappropriate daytime sleepiness and a simple inability to perform her employment duties as a result. The Respondent was treating her for phlebitis and arthritis, and thus she is an internal medicine patient. As such the Respondent monitored her physical condition quite closely, making physical examinations including monitoring of blood pressure when necessary. He observed no adverse effects caused by the administration of Dexedrine to this patient, which alleviated her narcoleptic symptoms and enabled her to remain productive and fully functional in her employment and daily pursuits. The Respondent thus diagnosed her as suffering from narcolepsy and established that as an appropriate basis for the prescription of Dexedrine. He continued to prescribe Dexedrine for the patient, even after he became aware of the restriction of its use because he genuinely believes that she is a true narcoleptic. Dr. Lindberg opined that the Dexedrine was inappropriate medication and was prescribed in excessive amounts. He did not believe that Ms. Heintz exhibited narcoleptic behavior, but he had never observed the patient and based his opinion merely upon less than detailed references to narcoleptic behavior in the patient's records. The Respondent, however, established that this patient had been a patient for many years and he was intimately familiar with the physical condition, complaints and medical history, and makes notes only for his own use. Because of his familiarity with her medical history and problems, it was unnecessary for him to make his own notes in sufficient detail so that Dr. Lindberg would be able to thoroughly review the patient's status and treatment indications by looking at her chart alone. Dr. Lindberg, in opining that the dosage was excessive at 30 mg. per day failed to take into account that the PDR provides that the accepted prescription of Dexedrine for narcolepsy is from 5 mg to 60 mg per day with no time limitation as to its use. His opinion as to excessiveness was based on the medical indications in the PDR for obesity only, not for narcolepsy. Such a dosage for this patient was not excessive in view of her proven diagnosis of narcolepsy. Count XXI concerns the purchase on October 14, 1981, of 1,000 quaalude tablets with regard to which it is alleged that the Respondent failed to maintain proper records justifying purchase and disposal of them as allegedly required by Section 21 USC 1306.04(b). Section 21 USC 1306.04(b) has not been placed in evidence in this proceeding, nor has it been made the subject of judicial notice, pursuant to Section 120.61, Florida Statutes. In any event, the 1,000 quaalude tablets were purchased by the Respondent for use by his wife, Harri Klotz. The Drug Enforcement Administration (DEA) Form 222, required to be maintained by the purchaser of such drugs was maintained by the Respondent and his office manager, and a dispensing record also maintained by them shows that the medication was dispensed upon receipt to Respondent's wife. In fact the drugs were established to be retained in the Respondent's office under lock and key and not physically dispensed to the Respondent's wife at one time, rather they were dedicated to her use, but maintained securely on the Respondent's office premises. Mrs. Klotz was then dispensed 30 tablets at a time in approximately one and one-half to two month intervals, and an additional journal card was established by Ms. Lindblom, the office manager, showing the dates when Mrs. Klotz drew down upon that medication in 30 tablet increments which withdrawals were recorded ads "pills dispensed." Additionally, the 130 methaqualone tablets prescribed for Mrs. Klotz on June 24, 1982, were for the purpose of providing her an additional supply to be used in a light, periodic, controlled manner because the drugs were about to become illegal. Later in August or September, 1982, Ms. Lindblom, when she became aware that the additional prescribing of methaqualone might be illegal, upon advice of Mr. Meiner, the Respondent's counsel, elected to dispose of the remaining quaalude tablets at which time 790 of the original 1,130 tablets dedicated to the use of Mrs. Klotz remained at the Respondent's office and were disposed of. Thus the receipt of 1,000 quaalude tablets was duly recorded in Respondent's record and the 30 tablet dispensations of the medication periodically from October 14, 1981 through June 28, 1982, were recorded in a dispensing record in evidence, which record also reflects the disposal of the 790 unused tablets.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses and the pleadings and arguments of counsel, it is, therefore RECOMMENDED: That the Administrative Complaint against the Respondent, Solomon D. Klotz, be DISMISSED except as to the minor violations of Section 458.331(1)(h) and (cc) Florida Statutes, proven with regards to Counts XI and XVIII for which, under the circumstances of this case, no disciplinary action should be taken. DONE and ENTERED this 4th day of May, 1984, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of May, 1984. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Chief Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Sam C. Meiner, Esquire 26 Wall Street Orlando, Florida 32801 Helen C. Ellis, Esquire 1804 Old Fort Drive Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact At all times pertinent to this hearing, Respondent, M. J. Warhola, was a doctor of osteopathic medicine and properly licensed as such by the State of Florida by license number OS 0001256, issued in 1957. He has been practicing osteopathic medicine at his present location in Tampa, Florida, for the past 17 or 18 years. Respondent first started treating Pearl O. Knowles in 1965. Generally, she was suffering from severe diabetes and was overweight. He also, over the years, treated her for arteriosclerosis. Among the drugs he was prescribing for her during the 1979-1989 time period were Placidyl (sleeping pill), Verstran (tranquilizer), Triavil (antidepressant), Dilantin (anticonvulsant) Teldrin (antiallergenic), Donnatal (sedative), Synalgos (painkiller), Talwin (painkiller), various antibiotics, and such other substances as insulin, stool hardeners, vitamins, diuretics, antihistamines, and antiemetics. During the period from January, 1979, through December, 1981, prescriptions written by Respondent for these varying medications for Mrs. Knowles or her husband were filled by area pharmacies in accordance with the following chart: MONTH/YR TOTAL MRS. K MONTH/YR TOTAL MRS. K Jan. 79 11 4 July 80 22 15 Feb. 79 15 7 Aug. 80 15 10 Mar. 79 10 5 Sept.80 26 19 Apr. 79 14 11 Oct. 80 20 10 May 79 13 10 Nov. 80 21 16 June 79 10 8 Dec. 80 22 17 July 79 11 6 Jan. 81 16 11 Aug. 79 15 10 Feb. 81 15 12 Sept.79 13 10 Mar. 81 25 17 Oct. 79 15 6 Apr. 81 26 17 Nov. 79 7 5 May 81 21 10 Dec. 79 17 12 June 81 11 4 Jan. 80 12 8 July 81 23 8 Feb. 80 17 12 Aug. 81 25 23 Mar. 80 21 17 Sept.81 5 5 Apr. 80 17 14 Oct. 81 20 14 May 80 24 22 Nov. 81 4 2 June 80 27 21 Dec. 81 2 2 TOTAL: 588 400 Many of the above instances are refills of the same prescription. According to Respondent, some prescriptions were authorized five refills without contact with him. Some, such as Prescription #27162 for 100 Triavil, initially filled on December 1, 1979, was subsequently refilled at least 11 times, and three other separate prescriptions for the same drug were filled multiple times. From January, 1979, through September, 1980, a period of 20 months, 30 tablets each prescriptions for Placidyl tablets, written by Respondent for Mrs. Knowles, were filled 46 times for a total of 1,380 tablets. During the same period, Triavil prescriptions for 100 capsules each written by Respondent for Mrs. Knowles were filled 22 times for 3,200 tablets, Talwin at 100 tablets 13 times for 1,300 tablets, at least 10 prescriptions for either Tylenol #3 or Fiorinol #3, both with codeine, at 50 tablets each for the Fiorinol at least totalling more than 509 tablets, as well as all the others stated in paragraph 2 above. Mrs. Knowles admits taking too much medication, but claims it is not the fault of Respondent. Whenever Respondent saw her and gave her a prescription for any medicine, he would tell her what dosage to take. She would see the Respondent every two or three weeks and get a new prescription each time and would also give her prescriptions at her request without her going to the office personally. Regardless of what instructions Respondent would give her concerning the dosage of the various painkillers and "nerve medicines" he would give her, she often exceeded the directed dose either by accident or in an effort to relieve the extreme pain she was experiencing in her hands and feet. Not only did she get drug prescriptions from Respondent, but by her own admission, she also saw other doctors during the period from whom she got "pain pills," as well as taking those given to her on her release from the hospitals to which she was admitted. She recognized that she was taking too many drugs at the time, but the pain was severe and she felt it was required. During this same period of time, from mid-1979 on through early 1982, while Mrs. Knowles was seeing Respondent for her diabetes and other chronic ailments, she was admitted to several hospitals in the area. On June 11, 1979, she was admitted to the Brandon Community Hospital (BCH) in Brandon, Florida (Brandon is a small community east of Tampa), in a confused and disoriented state. The admission diagnosis was diabetes with electrolyte imbalance. The attending physician noted at the time that the patient "is somewhat dependent on drugs." Approximately two months later, on August 15, 1979, Mrs. Knowles was again admitted to BCH, this time for uncontrolled diabetes and overdosing her drugs including Placidyl and Fiorinol. Again, the attending physician noted the failure of the patient to take care of her diabetes, her drinking, and her drug dependency. Mrs. Knowles thereafter stayed out of the hospital for about a year until, on September 1, 1981, she was again admitted to BCH, again for her diabetes. Secondary diagnoses on this occasion were hypertension and taxciencephalopathy, a disorder of brain function. At this time, she was seen in the hospital by Dr. Mark Stern. Based on the lab work performed and examination by Dr. Stern and other specialists to whom she was referred, it was concluded that her condition, aside from the diabetes and hypertension, was related to her overuse of drugs such as Talwin, Valium, Triavil, and the like. She was again seen by Dr. Stern at BCH on October 24, 1981, when she was admitted for an unintentional drug overdose. A drug screen done at the time of admission revealed a Placidyl level of 69.4 (normal level is 0.5 to 10, with toxic levels being greater than 20). A repeat test six and a half hours later showed the level of Placidyl at 62.4. Other lab tests showed opiates, benzodiazepan (tranquilizers such as Valium and Librium), and salecylates. When she was admitted on this occasion, she had with her a box containing several medicine bottles. Notwithstanding Petitioner's allegation that "Said labels were not labeled by Respondent," the testimony of Deborah Ann Brown, Director of Pharmacy at BCH, to whom the box of bottles was given for identification, shows that only one of all the bottles did not have the appropriate markings on it. It also appears that some of the medicines in the box had been prescribed for Mrs. Knowles' husband, Ira. Dr. Stern again saw Mrs. Knowles when she was brought to BCH on January 6, 1982, complaining of weakness and difficulty in walking. Again, her history showed she was taking antidepressants and Placidyl for chronic insomnia. Dr. Stern recalls that Mrs. Knowles telephoned him on October 9, 1981, and requested prescriptions for Placidyl, Triavil, and Talwin, but he refused to prescribe them for her. He terminated his relationship with her in August, 1982. During the period she was his patient, however, he did prescribe for her such substances as painkillers, sleeping pills, and antianxiety drugs, the same generic types of drugs as prescribed by Respondent, by written prescriptions, some of which called for multiple refills. Though Mrs. Knowles advised Dr. Stern that she was being treated by Dr. Warhola, Dr. Stern did not discuss her with Dr. Warhola or even contact him. Even when Mrs. Knowles threatened to get drugs from Respondent when Dr. Stern refused to give her prescription over the phone in October, 1981, Dr. Stern still did not contact Dr. Warhola. Between the fourth and fifth BCH hospitalizations, on December 21, 1981, Mrs. Knowles was admitted to Tampa General Hospital (TGH) and was examined by Dr. Jeffrey L. Miller, a rheumatologist internist, at the request of her regular physician, Dr. Sugarman. When Dr. Miller first saw her, Mrs. Knowles was overmedicated. She was confused, and her speech was slurred. She indicated to Dr. Miller that she was taking Triavil and other drugs as well, such as Zomax and Placidyl, but refused to tell him all the drugs she was taking. Those she mentioned are addictive, and it appeared that she was addicted because she had been hospitalized for nonaccidental overmedication and because her condition was consistent with addiction. Mrs. Knowles denied having a drug problem. In Dr. Miller's opinion, however, Mrs. Knowles was not receiving the proper therapy. Her diabetes did not require the drugs she was getting. Her other symptoms, in his opinion, did not justify the apparent liberal prescriptions she was getting and should have been treated with psychotherapy rather than drugs. In his opinion, therapy should be tailored for an individual like Mrs. Knowles so that the medication is limited and regulated to prevent addiction and the buildup of tolerance to a drug, which results in larger and larger doses. The evidence also shows, however, that Mrs. Knowles was a difficult patient. Dr. Sugarman was having difficulty with her and requested the consult by Miller. What must also be considered is that Mrs. Knowles' leg, about which she constantly complained of the pain, was subsequently surgically removed in 1982 as a result of her diabetes. The pain associated with this condition leading up to the amputation was real and required relief to some degree. In any case, Dr. Miller did not ever discuss Mrs. Knowles with Respondent or advise him of her addiction. Mrs. Knowles still receives painkillers and "nerve medicine" from her current physician, Dr. Sugarman, whom she sees every two weeks. She stopped seeing Dr. Warhola when she started seeing Dr. Sugarman, who, she felt, was more current in some of her problem areas than Respondent. She did not leave Respondent because she was dissatisfied with him. In fact, he was the only one who helped her blood clots. According to Respondent, he gave Mrs. Knowles the Placidyl for sleep because she had a lot of pain as a result of her diabetes and needed it to help her sleep. At this same time, Mrs. Knowles' husband was a severe alcoholic and, since she was under a lot of strain because of that, he gave her the drug to help her sleep. The call he got from Dr. Stern on October 26, 1981, when she was in BCH, indicating she was mixing drugs, was the first indication he had that she was abusing drugs. He told Stern she was not to get any more, and he, Respondent, has not prescribed any for her or seen her since. In fact, he was not informed of her hospitalizations in June or August, 1979, or in September, 1981. It is, even by the testimony of Petitioner's expert, Dr. Gladding, not uncommon in Florida for M.D.s to admit a D.O.'s patient to a hospital and not ever notify the D.O. of that fact. Mrs. Clifton M. Wood of Winter Haven, Florida, was first taken to see Respondent for a diet regimen in 1980. On the first visit on February 7, 1980, he gave her a physical examination which included a complete laboratory workup, cardiogram, and weight and pressure check. He gave her some pills which had instructions for use on the bottle, but did not tell her what they were. Each time she came to his office for a visit thereafter, on a monthly basis, either Respondent or his nurse would weigh her and take her blood pressure and adjust her medication as required. During the course of treating Mrs. Wood, Respondent gave her phedymetrazine, an appetite suppressant, methahydrine for high blood pressure, Donnatal, and vitamins and minerals. He gave Mrs. Wood only the drugs he felt she needed in the amount she needed. Mrs. Wood was admitted to Winter Haven Hospital on October 26, 1980, because a neighbor who was concerned about her brought her in. At the time, Mrs. Wood had trouble with dizziness, her balance, and falling. Before this incident, however, Respondent on one or more of his visits, had given her pills for her blood pressure and potassium pills for her to take in water. According to Dr. Gordon Rafool, who had also treated Mrs. Wood since 1979 and who admitted her to the hospital in October, 1989, at the time of admission, she was, among other things, dehydrated and had an electrolyte imbalance (lack of body salt, specifically potassium), the latter possibly being caused by the intemperate use of a diuretic. A diuretic is often used in cases of heart failure, high blood pressure, and, though not recommended, weight reduction, to get rid of body water. Since it was important to know what medicines Mrs. Wood was taking to help determine the reason for her condition, Dr. Rafool and other hospital personnel tried to get an identification of the drugs in Mrs. Wood's possession when she was brought in. The hospital pharmacy could not identify them, and no drug screen was done, but Dr. Rafool obtained a written authorization of Respondent to permit Respondent to release any information regarding drugs dispensed or prescribed to the patient by him. This authorization was forwarded to Respondent's office with a request for Mrs. Wood's medical records, but they were never released. Dr. Warhola's office manager, Mrs. Zacchini, states the request and authorization on Mrs. Wood were received, but were apparently inadvertently filed in the office record without the requested records being sent out. Though Dr. Rafool says that numerous follow-up calls were made to Respondent's office, Mrs. Zacchini denies any were received from either the hospital or Dr. Rafool. In any case, there is no evidence to indicate any calls were made to or received by Respondent directly, and he denies every having received any. Mrs. Wood still considers Respondent to be a good doctor, but she has not gone back to see him since her release from the hospital because Dr. Rafool told her to stay away from him. She has been seeing Dr. Rafool, who has been treating her with pills for her arthritis and high blood pressure. Petitioner presented the deposition of Dr. Lloyd D. Gladding, D.O., over the partial objection of Respondent, whose objection was not to the use of the deposition, but to specific parts thereof based on particular grounds. For example, Respondent objected to Dr. Gladding's testifying as an expert because, he contended, there had been no showing by Petitioner that the witness's experience compares to that of Dr. Warhola. He contends the witness does not practice in the same geographical area nor is there a showing he is a similar health care provider with a similar specialty or a similar type practice. However, Dr. Gladding's curriculum vitae, admitted without objection, shows he is currently co-chairman of a family practice seminar in his area and a clinical preceptor (teacher) at an osteopathic medical school and has been engaged in a family practice in the Fort Myers area since 1978. This area is geographically not far removed from the Tampa Bay area (the distance is not significant) and there is no showing that the patient conditions involved in the two cases at issue would or could be affected significantly by the geographical location of the patient or that treatment of these conditions varies greatly from location to location. In fact, according to this witness, he finds patients from widely differing areas (Pennsylvania, where he was trained, as opposed to Florida, where he practices) to be the same. Accepting the witness as an expert, then, with reference to Mrs. Knowles and her condition, he has had patients with a similar series of health problems where the patient was placed on multiple drug regimens. Sometimes, these patients developed drug dependencies for the different medications he prescribed. In the case of Mrs. Knowles, based on the number of Placidyl prescribed by the Respondent over about a year, she received enough to take two per day, which would constitute 1,500 mg. of the drug per day (two tablets of 759 mg. each). The drug company's recommended daily dose is between 590 and 750 mg. given at bedtime, with an additional 109 to 200 mg. later on, if needed. The fact that Mrs. Knowles was also getting other drugs, including a different type of sleeping pill, makes Dr. Gladding feel the prescriptions by Respondent were excessive. He admits, however, he does not know how much pain the patient was in and this makes it difficult to render an opinion. Because of this, he cannot unequivocally say that the dosage prescribed was excessive. Good practice is to prescribe as few Schedule II drugs as is possible. However, without knowing the patient, her attitude, and her actual condition, an opinion as to the appropriateness of the drugs prescribed, unless clearly inappropriate, would be merely guesswork. As to the patient Mrs. Wood, Dr. Gladding could not read Dr. Warhola's notes of what drugs he gave her. Therefore, in analyzing Respondent's prescriptions, he relied on and referred to a federal drug analysis of the unmarked drugs she got from Respondent as including barbiturates or their derivatives. This analysis was not introduced into evidence, and Dr. Gladding's reference to it is hearsay which cannot, by itself and without other independent evidence of the identity of the drugs, support a finding of fact even though it would appear some were drugs that would not be used in weight control. However, there were drugs identified independently, such as the potassium replacement and the weight reduction drug, which were appropriate and, in addition, the tranquilizer could also be appropriate. In any case, Dr. Gladding does not know what Mrs. Wood told Respondent about the problems she was having sleeping. If she did tell him this, even the barbiturates could be appropriate. Dr. Gladding has also been confronted with a situation where a patient of his has been hospitalized and the hospital calls him for information on the patient on an emergency basis. He knows, he says, everyone in the local hospitals and generally provides the requested information on the spot without a formal release. He is more concerned with the patient's welfare than with technicalities. However, in the case of Mrs. Wood, there was not an emergency situation and there was no showing Respondent was ever personally contacted. In addition, there was evidence of only one written release, not three, as reflected by the witness.
Recommendation Based on the foregoing, it is, therefore, RECOMMENDED: That the Administrative Complaint filed herein against Dr. Warhola be dismissed, but that he be officially reminded of the necessity to conservatively prescribe controlled substances in the course of his practice. RECOMMENDED this 6th day of March, 1984, in Tallahassee, Florida. ARNOLD H. POLLOCK 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 6th day of March, 1984. COPIES FURNISHED: James H. Gillis, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32391 Gerald Nelson, Esquire 4950 West Kennedy Boulevard Suite 693 Tampa, Florida 33609 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee. Florida 32301 Ms. Dorothy Faircloth Executive Director Board of Osteopathic Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issues are whether, contrary to section 409.913, Florida Statutes, and Florida Administrative Code Rule 59G-9.070, Respondent has committed violations in core- competency training for nine employees (Eula Brown, Natasia Bernard, Lorine Smiley-Lewin, Taneish Mayers, Irene Thompson, Therese Etienne, Adrae McCalla, Marline Ford, and Cynthia Phinn), "medication administration/validation training" for seven employees (Ms. Bernard, Ms. Smiley-Lewin, Ms. Mayers, Ms. Thompson, Ms. Etienne, Ms. Ford, and Ms. Phinn), service authorizations for two consumers (J. B. and L. H.), and Level 2 background screening and HIPAA training for one employee (Ms. Ford). If Respondent is guilty of any of these violations, an additional issue is the fine that should be imposed.
Findings Of Fact At all material times, Respondent owned half of the shares of Glory House USA, Inc., which, for ten years has operated one or more group homes for the developmentally disabled. At all material times, Respondent has been a Medicaid provider of services under the Florida developmental disabilities waiver program. For 2011, Respondent received $790,367.16 in Medicaid reimbursements for services provided to Medicaid consumers. At all relevant times, Respondent has been subject to a Medicaid Provider Agreement. In this agreement, Respondent agreed to comply with all federal, state, and local laws, including rules, regulations, and statements of policy applicable to the Medicaid program. In particular, Respondent agreed to comply with Petitioner's Medicaid handbooks. On September 29, 2011, Petitioner's inspectors conducted an unannounced inspection of Glory House. During the course of the inspection, Petitioner's inspectors spoke to Respondent's home manager, who answered the inspectors' questions, supplied all of the requested documents that were readily available, and took the inspectors on a tour of the facility. The Medicaid Developmental Disabilities Waiver Services Coverage and Limitations Handbook issued by Petitioner, effective May 2010 (Medicaid Handbook) Appendix A identifies the assurances required by Petitioner and the Agency for Persons with Disabilities (APD) of providers of services under the Developmental Disabilities Home and Community-Based Services Waiver. Appendix A Section 2.1 imposes specific training requirements on providers and their employees. Appendix A Section 2.1.G imposes the requirement of core competency training upon "[a]ll direct service providers . . . within 90 days of employment." As of the date of the inspection, seven employees, who had been employed by Respondent's corporation for over 90 days, had not completed direct-care core competency training: Ms. Brown, Ms. Bernard, Ms. Smiley-Levin, Ms. Mayers, Ms. Thompson, Ms. Etienne, and Ms. Phinn. Petitioner has thus proved seven of the nine alleged violations of this training requirement. Respondent's corporation employed Ms. Ford in July 2011, so she was still in her first 90 days of employment at the time of the inspection and was not yet required to have completed her core competency training. Petitioner seems to have relied on an earlier date shown in Petitioner Exhibit 3, but this date purports to show the date of the employee's application, not the date of hire. The only evidence of Ms. Ford's hire date is the testimony of Respondent's daughter, who is the assistant administrator, and she places the date of hire in July 2011. Ms. McCalla had completed the required training prior to the site inspection. Certificates documenting this training show that Ms. McCalla completed the APD Core Competency Training I on September 14, 2006, and APD Core Competency Training II on September 19, 2006. For the two reasons noted in the Conclusions of Law, it is irrelevant that Respondent may not have provided the certificate to the inspectors at the time of the inspection, so the Administrative Law Judge declines to make a finding of fact on whether Respondent provided these certificates to Petitioner at the time of the inspection or within the 15 additional days allowed by the inspector for the provision of documents, as noted below. On the other hand, Respondent's argument that core competency training was only required of employees providing unsupervised direct care to consumers is unsupported by the above-cited provision of the Medicaid Handbook. The allegation as to "medication administration/validation training" is a composite allegation. As noted in the Conclusions of Law, certain employees of providers must undergo medication administration training and validation; these are separate requirements. Also, there is no requirement of "validation training," as suggested by Petitioner's allegation. As of the date of the inspection, six of the seven named employees had completed medication administration training. Ms. Ford was the only employee who had not completed medication administration training, but she did not, at the time, administer medication to consumers or supervise their self-administration of medication. As explained in the Conclusions of Law, the Administrative Law Judge has rejected Petitioner's claim that Respondent had to affirmatively designate those employees who were not allowed to administer medications or supervise the self-administration of medications, so the Administrative Law Judge declines to make a finding of fact on whether Respondent so designated any such employees. Petitioner has thus failed to prove any of the seven alleged violations of this training requirement. As of the date of the inspection, three of the seven named employees had current validations for medication administration: Ms. Mayers, Ms. Etienne, and Ms. Phinn. (Like Ms. Ford, though, Ms. Etienne did not, at the time, administer medication to consumers or supervise their self-administration of medication, so Petitioner's proof as to Ms. Etienne fails on two grounds.) Because, as noted above, Ms. Ford was not designated to administered medications or supervise the self- administration of medications, Petitioner has thus proved three of the seven alleged violations of the validation requirement: Ms. Bernard, Ms. Smiley-Lewin, and Ms. Thompson lacked the required validations. As of the date of the inspection, one employee--the peripatetic Ms. Ford--had not completed HIPAA training. However, the record fails to establish the specific details of this requirement. In its proposed recommended order, Petitioner has relied on two documents: the Non-Institutional Medicaid Provider Agreement (Petitioner Exhibit 1, p. 16), which states only: "The provider agrees to comply with local, state, and federal laws, as well as rules, regulations, and statement of policy applicable to the Medicaid program, including the Medicaid . . . Handbooks . . . "; and the Medicaid Handbook, which states: Florida Medicaid has implemented all of the requirements contained in . . . HIPAA. [A]ll Medicaid providers, including their staff . . ., must comply with HIPAA privacy requirements. Providers who meet the definition of a covered entity according to HIPAA must comply with HIPAA Electronic Data Interchange (EDI) requirements. . . . For the reason noted in the Conclusions of Law, Petitioner has failed to prove its alleged HIPAA-training violation. As of the date of the inspection, Ms. Ford had submitted unspecified documentation sufficient to allow the Department of Children and Family Services (DCF) to issue a letter, dated June 29, 2011, documenting "the final results of a criminal history records check received by [DCF], required by Florida Statute for the below stated program," which is noted as an "APD Foster/Group Home." The letter further states: "[DCF] received the complete criminal history records for [Ms. Ford]. Nothing was found in the Department's review that disqualifies the individual from serving in the program . . . for which this screening was requested and is required by law." The letter adds that "[t]his screening remains valid for five years providing the applicant does not have a 90 day break in service " The Medicaid Handbook, at page 55, states: Direct service provider applicants must comply with the requirements of a level 2 screening in accordance with section 435.04, F.S. Compliance with this requirement may be accomplished through one of two ways: ?Background screening pursuant to s. 393.0655, F.S., or Applicants must submit a fingerprinting card, an affidavit of good moral character, a caretaker information sheet, and a check . . . to DCF for processing. . . . The results of this screening will be submitted with the Medicaid enrollment application. ?Background screenings pursuant to section 409.907, F.S. Applicants must submit a fingerprint card with the Medicaid Enrollment Application and a check made payable to the Medicaid fiscal agent for processing; or, if available, the applicant may submit the screening through an approved live scan location. Screening is performed at the time of enrollment and every five years thereafter. It is the responsibility of the applicant or provider to ensure this request for screening or rescreening is submitted for processing in a timely manner. Assuming that the cited provisions impose any duty upon Respondent beside ensuring that the employee or prospective employee timely submits her request for screening or rescreening, it is difficult to understand how Ms. Ford's screening document fails to satisfy the second alternative in the first bulleted paragraph. It certainly appears that Ms. Ford submitted the required items to DCF for processing, and DCF found nothing to prevent her employment at Glory House. Further confirming its responsiveness to the screening requirement in the Medicaid Handbook, the DCF letter even notes that it is good for five years. Petitioner has thus failed to prove its alleged screening violation. Medicaid Handbook Appendix A Section 3.6.E states that a provider may "[b]ill for only those services for which an approved service authorization has been received. Copies of service authorizations shall be kept on file by the provider and shall be made available to APD, [Petitioner], or their authorized representatives for monitoring purposes." As of the date of the inspection, L. H. and J. B. had current service authorizations. The terms of these authorizations were July 1, 2011, through June 30, 2012. Petitioner has thus failed to prove the two service authorization violations. By letter hand delivered to the home manager on September 29, 2011, Petitioner provided Respondent with an additional 15 days to provide, among other things, all employee records, including level 2 background screens. The letter is not free from ambiguity, largely because it is a form for use in a Medicaid-overpayment case that, in this case, covers a list of items that Respondent needed to provide Petitioner following the inspection. In any event, the letter cannot be interpreted as extending the time for compliance with the underlying requirements. In other words, if an employee obtained a medical administration validation on October 5, 2011, it would not obviate the violation. As the Administrative Law Judge noted at the hearing, such an interpretation of the letter would enable providers to ignore many Medicaid program requirements until Petitioner conducted an inspection and then avoid any sanctions by belatedly coming into compliance--after the inspection uncovered violations. There is no indication of prior offenses by Respondent under the Medicaid program. Thus, as defined in the rule discussed in the Conclusions of Law, the ten proved violations all are a first offense for the purpose of identifying the proper fine per violation.
Recommendation It is RECOMMENDED that the Agency for Health Care Administration enter a final order finding Respondent guilty of seven violations of the core competency training requirement and three violations of the medication administration validation requirement and imposing a fine of $10,000. DONE AND ENTERED this 12th day of July, 2012, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE 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 12th day of July, 2012. COPIES FURNISHED: Jeffries H. Duvall, Esquire Agency for Health Care Administration Fort Knox Building 3, Mail Stop 3 2727 Mahan Drive Tallahassee, Florida 32308 jeffries.duvall@ahca.myflorida.com Randy A. Fleischer, Esquire Randy A. Fleischer, P.A. 8258 State Road 84 Davie, Florida 33324 randy@igc.org Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Stuart Williams, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Elizabeth Dudek, Secretary Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 1 Tallahassee, Florida 32308
Findings Of Fact On June 27, 1991, Petitioner applied for licensure in the State of Florida by endorsement as a physician. He is presently licensed in the states of Alabama, Louisiana and Wisconsin. He is board eligible in dermatology and is currently a house physician for New Orleans General Hospital in New Orleans, Louisiana. On January 5, 1993, Respondent denied Petitioner's Florida application because of Petitioner's previous history of psychiatric problems and psychotherapy which affected his ability to practice medicine with skill and safety; his current psychiatric and psychological evaluations indicating an obsessive-compulsive disorder which could affect his abilities to practice with skill and safety; and the prior denial of his licensure application in 1987 as the result of material misrepresentations in the application. On three separate occasions, Petitioner has applied for licensure in Florida. In addition to the current application, he applied on April 4, 1986 and on August 2, 1990. Following a formal hearing, the 1986 application was denied on December 22, 1987, as the result of misrepresentation in the application. An application for admission filed in 1990 was subsequently not timely completed and became void. All of Petitioner's applications and materials submitted with regard to those applications are maintained by Respondent in one file, a normal practice for Respondent. Documents in that application file have been generated by Respondent or supplied by Petitioner. Diagnosed in 1977 with an obsessive-compulsive disorder, obsessive- compulsive personality and dysthymia, Petitioner has been receiving treatment for his mental illness since 1979. He was hospitalized for a psychotic episode in 1987. From 1988 until the present, Petitioner has been taking Sinequan and Mellaril. The daily dosage of 50 milligrams of Mellaril has not varied during that time period. The daily dosage of Sinequan initially was 150 milligrams per day, tapered to 40 milligrams each night at present. About three months ago, Petitioner began taking about a gram of Valproic acid each night. These medications have a sedating or hangover effect on Petitioner in the morning. At one point in 1992, Petitioner temporarily switched to another drug, Anaframil, for a month to a month and a half. One of the reasons for the switch was that Petitioner was going to be reevaluated by a psychiatric expert, Dr. Dohn, at Respondent's request. Dr. Dohn's previous evaluation had expressed concerns about possible effects on Petitioner's clinical abilities as a result of medication side effects. After Dohn's second evaluation of Petitioner, Dohn was much more confident of Petitioner's abilities in view of the then change to Anaframil for treatment of Petitioner's obsessive-compulsive disorder. Mellaril and Valproic acid are psychotropic medications which have confusion as a side effect. Sinequan can have confusion and sedation as a side effect. Valproic acid also has a sedating effect. The dosage of these medications as taken by Petitioner are sufficient to produce these side effects. The effects of the medications carry over to the following day, although taken the evening before. Psychological evaluations of Petitioner dated October 7, 1991 and August 28, 1992, reflect that Petitioner's cognitive abilities have been affected by his mental condition, inclusive of the medications he takes. The 1991 evaluation documents Petitioner's difficulties with recall of verbal instructions and numbers presented verbally to him; completing eye-hand coordination tasks within the maximum time limit; distinguishing visual details; and a tendency to become stymied with anxiety. Further, the 1992 report indicates that certain symptoms of Petitioner's obsessive-compulsive disorder could conceivably interfere with his ability to perform surgery. The 1992 report was done following testing of Petitioner after his brief change to the drug, Anaframil. Following Petitioner's 1992 evaluation by Dr. Dohn, conducted in close proximity to the August 1992 psychological evaluations, Petitioner quit taking Anaframil and resumed his previous medications of Mellaril and Sinequan. At deposition following a recent psychiatric evaluation of Petitioner by Dr. Edward Foulks, Foulks opined that Petitioner's illness should not be a barrier to the practice of medicine. Foulks opinion is not credited in view of his lack of independent knowledge of Petitioner's medications or mental condition; his lack of knowledge of whether Petitioner's condition had stabilized; how the condition had been resolved; or how much further treatment Petitioner would likely require. Foulks' opinions were based in large part upon Petitioner's representations to him. Petitioner's evaluations from Lazarus S. Gerald of the University of Pennsylvania Department of Dermatology, dated August 21, 1990 and July 8, 1991; from the chief of the Dermatology Department of Lloyd Noland Hospital and Clinic in Fairfield, Alabama, dated August 21, 1990; and from Dr. Derek J. Cripps, Director of the Department of Dermatology of the University Station Clinics, University of Wisconsin, note Petitioner's psychiatric condition as a possible explanation for performance difficulties. In 1986, Petitioner made numerous misrepresentations in his application for licensure. He answered "no" to the application question of whether he had a mental or emotional illness, although he had been ill since 1977 and had been treated from 1979 until 1986 by several psychiatrists. He also answered "no" to whether he had received psychotherapy. He was suspended from seeing patients during the last three months of residency at the University of Wisconsin, but answered "no" to the question of whether he had ever ceased practice for more than a month. He also answered "no" to the question of whether he had ever been denied hospital privileges or had such privileges acted against. In his August 2, 1990 application, Petitioner again answered "no" to whether he had been denied hospital privileges or had his hospital privileges acted against. Later, recognizing that this was not an accurate representation, Petitioner forwarded an affidavit, dated May 16, 1991. In that affidavit, Petitioner changed his answer to "yes". While only receiving partial credit of three months for his residency at the University of Wisconsin, Petitioner listed the dates on the form so that it appeared that he had received one year's credit. In his current application, dated June 27, 1991, Petitioner again failed to show that he only received partial credit for his residency at the University of Wisconsin. An affidavit dated November 21, 1991, was submitted by him regarding the residency program at Tulane University in which he was then participating. The affidavit failed to indicate that his participation in the residency program was conditioned upon his being in the impaired residents program and that the residency lasted 18 months, although he needed only six months to complete residency requirements for the dermatology board examination. Petitioner also failed to tell his supervising physician at Tulane, Dr. Shrum, of Petitioner's previous application for licensure in Florida or denial of that application for licensure, until after Shrum had been deposed regarding Petitioner's reputation for truthfulness.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered denying the application for licensure by endorsement. DONE AND ENTERED this 10th day of December, 1993, 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 10th day of December, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-1671 The following constitutes my specific rulings, in accordance with Section 120.59, Florida Statutes, on findings of fact submitted by the parties. Petitioner's Proposed Findings. 1.-2. Accepted. Rejected, weight of the evidence. Rejected, cumulative. Subordinate to HO findings. Accepted. Subordinate to HO findings. 8.-13. Accepted, but not verbatim. 14. Rejected, credibility. 15.-20. Rejected, unnecessary. 21.-25. Subordinate to HO findings. 26. Rejected, credibility. 27.-38. Rejected, credibility. 39.-45. Rejected, credibility. 46.-51. Rejected, subordinate to HO findings. 52. Rejected, relevancy. 53.-59. Rejected, credibility. Respondent's Proposed Findings. 1.-13. Accepted, but not verbatim. COPIES FURNISHED: Claire D. Dryfuss, Esquire Department of Legal Affairs The Capitol, PL-01 Tallahassee, Florida 32399-1050 Steven W. Huss, Esquire 1017-C Thomasville Road Tallahassee, Florida 32303 Jack McRay General Counsel Department of Business and Professional Regulation The Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750 Dorothy Faircloth Board of Medicine Department of Business and Professional Regulation The Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750
Findings Of Fact The Respondent, Dr. Irvine K. Furman, is a licensed medical doctor having been issued license no. ME0004572. The Petitioner is an agency of the State of Florida charged with enforcing the provisions of Chapter 458, Florida Statutes which concern and embody standards by which physicians are licensed in the State of Florida and permitted to maintain licensure and medical practice in the State. The Respondent received his medical training in the early 1940's and then served in the military services of the United States during and after World War II. Thereafter he worked for a time as a medical examiner and then did a four year surgical residency in Columbia, South Carolina. He came to Florida in approximately 1950 and practiced medicine for a short time in Lake City. He then moved to Jacksonville and entered medical practice, continuing that practice until 1985. Most of his years as a physician have been in the field of general surgery, with about one-third of that practice for a 25 year period in the area of gynecological surgery. He has also practiced surgery extensively in the areas of aorta transplants and artificial joint replacements. He taught surgical residents for many years in area hospitals. During the course of his practice, since approximately 1950, he has always performed any surgery required by his family members and has otherwise treated members of his family, including his wife. Over the years of his practice, he has established an exemplary reputation as a physician and surgeon with his colleagues in the medical profession, even to the extent of being chosen to teach surgery. He was the recipient of numerous accolades from his colleagues upon his departure from active practice in 1985. Prior to the action sub judice, he has been the object of no complaint or proceeding, either formal or informal, by the Department of Professional Regulation, Board of Medical Examiners, or any predecessor agency, nor has any complaint been reported to such agency concerning any aspects of his practice. On approximately September, 1985, the Respondent suffered a heart attack and underwent related heart by-pass surgery. He still complains of shortness of breath on exertion and his doctor, Scott Baker, M.D., believes that the strain of active surgical practice would be too physically taxing for him at the present time, coupled with his other physical conditions involving allergies, asthma, and previous cancer surgery of the colon. The Respondent indicated that he agrees with the assessment and no longer feels that he can engage in active surgical practice. The Respondent has treated his wife, Lorena or Lori, Furman for many years for various ailments and conditions. In the mid 1950's, she suffered a toxemic pregnancy and, due to the complications associated with that condition, chose to have a therapeutic abortion. While that procedure was being performed, she lost a great deal of blood and the Respondent, (who was not performing the procedure, but was present at the time) due to, apparently, inexperience or uncertainty on the part of the physician in charge of the procedure, stepped in and "packed " her uterus to alleviate the abnormal blood loss. The next day, the uterine pack was mistakenly removed, without the knowledge of the Respondent, which resulted in more blood being lost. After a few additional days in the hospital, Mrs. Furman was discharged and went home. Following this incident, she developed health problems that the Respondent, who was treating her by that time, traced to the abnormal blood loss condition such that he diagnosed her resulting condition as "Sheehan's Syndrome." Sheehan's Syndrome is a specific disease that occurs secondary to hemorrhage associated with pregnancy. Excessive hemorrhage results in a drop of blood pressure sufficient to decrease profusion, or blood flow, to the anterior pituitary gland which results in the loss of certain essential bodily hormones. This situation occurs because an infarction or damage process to the anterior pituitary gland, due to loss of blood, causes the pituitary to cease functioning or to significantly decrease its functioning level. Thus, the hormones produced by the pituitary gland and the thyroid gland hormones, which are triggered by the action of the pituitary gland, become no longer available to the body. These hormones are not otherwise replaceable by the patient's body. The normal course of treatment for a true Sheehan's Syndrome condition is to replace the functions lost by the death of, or damage to, the pituitary gland. This treatment would include, but not necessarily be limited to, the provision of sex hormones, steroids, thyroid hormones, adrenaline hormones and, in conjunction with their replacement, the management of the potential side effects of the hormonal therapy. The physician managing a case of true Sheehan's Syndrome would, through the course of treatment, also typically compile voluminous lab work and related records reflecting investigation of steroid levels, serum cortisol levels, ATCH levels, and thyroid stimulating hormone levels. The Respondent's medical records regarding his wife's care do not reflect this type of treatment pattern. The records rather indicate that various studies were done by other practitioners, but do not reflect that any of them confirmed his diagnosis of Sheehan's Syndrome. The records largely consist of logging of medication and brief summaries regarding his wife's physical condition and changes in her physical condition. The Petitioner's expert witnesses, Doctors Wilson and Clark, examining the records of Respondent's treatment of his wife, noted the absence of any findings that she had ever suffered shock during the obstetric incident in question. Normally, blood loss would have to occur of a sufficient magnitude to produce the condition of shock in the patient in order for the requisite damage to the pituitary gland to occur so as to result in Sheehan's Syndrome; that is, an essentially total loss of function of the pituitary gland. The medical records in question do not demonstrate evidence of lost hormonal functions in the body which would normally be expected with a dead or severely damaged pituitary gland. The records do not reflect the "replacement therapy" which would be expected and required in order to replace the glandular functions lost. Thus, largely for these reasons, the Petitioner's experts concluded that the Respondent's diagnosis of Sheehan's Syndrome was incorrect. Both Doctors Wilson and Clark are family practitioners who have practiced in that area in Jacksonville for 17 years and five years respectively. Both are somewhat familiar with toxemic pregnancies and pituitary gland malfunction conditions. The treatment for Sheehan's Syndrome and pituitary gland malfunction is the essentially the same. In this connection however, although they opined that the diagnosis was incorrect, these witnesses have never actually diagnosed a case of Sheehan's Syndrome nor experienced treatment of a patient with that syndrome themselves. It is also noteworthy that neither of the witnesses had treated, diagnosed or even seen the Respondent's wife. Consequently, the evidence of record does not definitively establish whether the Respondent's wife actually suffered from Sheehan's Syndrome. Regardless of the accuracy of the diagnosis however, it has been established that the Respondent's treatment of his wife was below the level of care, skill and treatment recognized by reasonably prudent, similar physicians, as acceptable under similar conditions and circumstances, even if she were actually suffering from Sheehan's Syndrome. The generally recognized treatment for that condition involves total hormone replacement which was not shown to have been done in the instant situation. The Respondent did prescribe Premarin, which is a synthetic estrogen, commonly used for post-menopausal hormone replacement. The amount and frequency with which it was given, however indicates that it may have been given only for menopausal replacement rather than as a treatment related to Sheehan's Syndrome. Additionally, that condition is generally recognized to require long term use of steroids, which was not apparently a part of Mrs. Furman's medication plan. The Respondent prescribed thyroid medication which is appropriate with Sheehan's Syndrome since the pituitary gland has ceased functioning and is no longer able to stimulate the production of thyroxen by the thyroid gland. The thyroid medication, in limited amounts, was prescribed, however, without first securing a thyroid evaluation. Instead of total hormone replacement, much of the medication prescribed by the Respondent consists of controlled substances, particularly pain medications. Between January 21, 1985 and January 21, 1986, the Respondent prescribed the following medications in the following quantities: Substance Quantity Demerol 100 mg. 405 Ampules (1cc. size) Demorol 100 mg. 51 Ampules (20cc. size) Demerol 100 mg. 45 Ampules (2cc. size) Demerol 75 mg. 29 Ampules (1.5cc. size) Demerol 50 mg. 7 vials (30cc. size) Restoril 30 mg. 2,890 Dolophine 5 mg. 1,100 PBZ 50 mg. 30 Butizol 30 mg. 685 Tenormin 50 mg. 100 Fiornal 30 Demerol is a Schedule II controlled substance and is a narcotic pain reliever. Restoril is also a controlled substance used as a tranquilizer to induce sleep. Dolophine is also a controlled substance used as a sedative. PBZ is an antihistamine commonly used to treat allergic reactions when a sinus infection is present. Butisol is a controlled substance used as a sedative which has habit forming characteristics. It is sometimes used for control of headaches. Tenormin is a "betablocker." Its main purpose is to slow down the heart rate to a certain degree and it is used to treat hypertension, and to alleviate the adverse effects of coronary artery disease. Sometimes it is used to prevent migraine headaches. It is not a controlled substance. Fiornal is a controlled substance which is a combination of Butisol and aspirin. It has some analgesic action as well as anti-inflammatory benefits. The Demerol, Restoril, Dolophine, Butisol, and Fiornal prescribed by the Respondent are addictive substances. A physician should be aware of this fact and the Respondent clearly was. The Respondent however felt in his exercise of medical judgment that his wife's pain episodes were severe and frequent enough that he had to risk addiction in order to alleviate her suffering, which he felt both professionally and humanely bound to do. Consequently, he exercised a considered decision to risk addiction and then later to attempt to alleviate the addiction, in order to bring some measure of relief, from pain and inability to sleep, for his wife. Indeed, the Respondent on occasion withdrew all medication in decreasing dosage stages and was able to successfully alleviate her addiction. Thus, it cannot be determined that the Respondent prescribed the controlled addictive substances with any wilful or negligent disregard of the addictive consequences. Rather, in the exercise of his medical judgment, he felt it was more appropriate to relieve her suffering first and be concerned about curing any resulting dependency as a secondary goal, which he apparently was successfully able to accomplish. Indeed, his wife has been off all medications since September, 1986. There is no question that the Respondent's efforts at relieving his wife's discomfort by prescribing the controlled substances noted were well- intentioned. Some of those prescribed, and some of the amounts prescribed, were without adequate justification, however. There were insufficient attempts, through testing, reference to appropriate specialists and appropriate consultations with other physicians, to address the causes of his wife's apparent chronic pain. Indeed, Mrs. Furman at times exhibited symptoms which indicate adverse side effects caused by some of these medications, such as cramping, diarrhea, vomiting, and bloody stools. Few apparent attempts were made to evaluate the causes of these symptoms by testing or evaluation by appropriate specialists. The Respondent's approach to treatment of his wife's symptoms and any new symptoms, such as those named above, (which might involve side effects to medications) was often to prescribe additional medication, rather than seek outside consultation in evaluating the cause of the symptoms. In some instances, the amounts of medication, particularly pain relievers, exceeded that which was warranted for the situation at hand. While the medications given were of a type generally appropriate to the symptoms exhibited, in some instances the amounts appear excessive for the situation with which the Respondent was confronted. In many cases, they were not justified because of the Respondent's failure to seek appropriate evaluation of the cause of his wife's symptoms after they persisted for long periods of time in the face of continued administering of the named medications. The written medical records which the Respondent maintained, although voluminous, fail to adequately justify the course of treatment. They do not reflect repeated evaluation of the persistent symptoms; adequate evaluation and follow-up of the results of medication, either as to effectiveness or side effects; laboratory tests, to monitor the various hormonal levels or objective findings regarding her clinical condition. If anything, his records should have been more complete and adequate in treating his wife, so as to adequately justify his diagnosis and treatment, and to help him guard against the high potential for loss of objectivity risked by any physician treating his wife or a close member of his family. The Respondent's records simply do not adequately justify the course of treatment followed. The Respondent was examined by a psychiatric expert, Dr. Ernest Miller. His opinion, as well as that of Dr. Wilson, shows that the Respondent had lost his objectivity with regard to treating his wife's ailments. He developed a fixed idea that she suffered from Sheehan's Syndrome and rather doggedly pursued that idea to the exclusion of seeking or acting on other medical opinions or advice. He apparently convinced himself that he was the only physician who understood or was capable of understanding the peculiarities of his wife's condition and of treating her satisfactorily. The results of the psychiatric examination show that the Respondent had intact cognition and there were no signs to suggest any organic neurological deficits. He was found to be a very skillful physician and surgeon and generally well qualified to practice medicine, except for the finding that he was not capable of objectively treating his wife and had developed the above- mentioned fixation regarding his view of the proper course of treatment for her by himself alone. He also underwent a physical examination by a physician chosen by the Petitioner and was found to be well-developed and well-nourished with no acute distress, well oriented to time, place, person, and situation. His memory for current, recent, and remote events and his motor and sensory systems and strength appeared intact. He does not use alcohol, drugs, narcotics or other chemicals. There is not question that the Respondent has been very dedicated to his wife's care. It is clear from the evidence however, that he has lost objectivity regarding the handling of his wife's case and ailments and is not able to practice medicine with reasonable skill and safety toward her because of this emotional state. It has not been shown that he is impaired in any way in practicing with reasonable skill and safety toward other patients in his practice within his physical limitations. Some of the Respondent's treatment approaches for his wife were illogical, although well-intentioned. As example, he maintained his wife had an allergy to milk products and yet later had her on a diet which included a great deal of skim milk and eggs, as well as cheese. He maintained that she retained excess fluid as a result of salt intake, and tried to restrict her diet as to salt. At other times, however, he had her on a diet which included products containing significant amounts of salt. In short, the Respondent clearly wanted to care for his wife properly, yet he did not deign to consult other physicians about her case. He claimed to only use tests when he wanted to change something in her medication regimen, despite the factual, as opposed to merely interpretive, information that he could have obtained from appropriate laboratory evaluation, i.e. whether various glands were functioning properly; at what level they were functioning and what the various hormonal levels were. Indeed, in 1963, when an endocrinologist examined Mrs. Furman and found nothing unusual in terms of glandular function and hormonal levels, the Respondent ignored that information and continued "dietary therapy" and heavy administration of medicines. In summary, it has been demonstrated that the Respondent, through his loss of objectivity, due no doubt to his understandably strong attachment to his wife and concern for her condition, is not capable of practicing medicine with reasonable skill and safety toward her. His physical limitations preclude him from the safe practice of surgery. Indeed the Respondent admits that, due to his heart attack and resultant heart by-pass surgery, with continued shortness of breath upon exertion, that he can no longer undertake the strains of surgical practice. The evidence of record however, does not demonstrate that the Respondent is unable to safely engage in the general practice of medicine with regard to patients other than his wife, so long as he does not engage in surgical practice. It has not been shown that he does not have adequate medical judgment and skill regarding the types of medications and therapies which are appropriate for given conditions or ailments which he might encounter in the general practice of medicine. Because of his loss of objectivity as to his wife's condition, he prescribed medications of a type generally appropriate, although sometimes in excessive amounts, for the conditions he perceived his wife to be suffering. His evaluation techniques were not adequate or were entirely lacking as a basis for his diagnoses and opinions, however. Thus he did not have an adequate diagnostic predicate for prescribing the medications, in many instances.
Recommendation Accordingly, having considered the foregoing Findings of Fact, Conclusions of Law, the Evidence of Record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties, it is, therefore RECOMMENDED that the Respondent's medical license be restricted so as to prohibit him from performing any surgery or maintaining a surgical practice of any type and from practicing medicine in connection with his wife or acting as her physician in any way, until such time as he is able to demonstrate to the Board of Medicine that he is mentally and physically capable of practicing medicine with regard to her with reasonable skill and safety. It is, further, RECOMMENDED that the Respondent, with regard to his continued general practice of medicine be required to forthwith comply with Section 458.331(1)(m), Florida Statutes, by maintaining at all times adequate, written medical records justifying the course of treatment for all patients, including, but not limited to, patient history, examination results, and test results. DONE and ORDERED this 30th day of November, 1987, in Tallahassee, Florida. P. MICHAEL RUFF 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 30th day of November, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-510 Petitioner Department's Proposed Findings of Fact Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Rejected as subordinate to the Hearing Officer's findings regarding this subject matter. Rejected as subordinate to the Hearing Officer's findings regarding this subject matter. Rejected as subordinate to the Hearing Officer's findings regarding this subject matter. Rejected as subordinate to the Hearing Officer's findings regarding this subject matter. Accepted. Accepted. Accepted. Accepted, but subordinate to the Hearing Officer's findings on this subject matter. Accepted. Accepted. Respondent's Proposed Findings of Fact Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted. Accepted in part, but subordinate to the Hearing Officer's findings regarding this subject matter. Accepted in part, but subordinate to the Hearing Officer's findings regarding this subject matter. Accepted in part, but subordinate to the Hearing Officer's findings regarding this subject matter. Accepted in part, but subordinate to the Hearing Officer's findings regarding this subject matter. Accepted. Rejected as subordinate to the Hearing Officer's findings on this subject matter. Accepted. Accepted in part, but subordinate to the Hearing Officer's findings regarding this subject matter. Rejected as subordinate to the Hearing Officer's findings regarding this subject matter. Accepted. Accepted in part, but subordinate to the Hearing Officer's findings regarding this subject matter. Accepted. Accepted. COPIES FURNISHED: Julie Gallagher, Esquire Senior Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Charles J. Franson, Esquire Drew W. Prusiecki, Esquire Post Office Box 10840 Jacksonville, Florida 32247 Tom Gallagher, Secretary 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil General Counsel 130 North Monroe Street Tallahassee, Florida 32399-0750 Dorothy Faircloth Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
