The Issue Whether Petitioner's license should be changed from Standard to Conditional and/or disciplined.
Findings Of Fact Brynwood is a 97-bed licensed nursing home located in Monticello, Florida. On April 23 through 25, 2002, AHCA conducted a survey of Brynwood. AHCA asserted two "tag" deficiencies involving Resident No. 4. The deficiencies involved Tag F-309 and Tag F-314. Tag F 309 represents 42 C.F.R. Section 483.25, which states that, Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care. Tag F-314 represents 42 C.F.R. Section 483.25(c), which states that, Based on the comprehensive assessment of a resident, the facility must ensure that a resident who enters the facility without pressure sores does not develop pressure sores unless . . . they were unavoidable; and a resident having pressure sores receives necessary treatment and services to promote healing. . . . Resident No. 4 was admitted to Brynwood on September 21, 2001. Resident No. 4 had congestive heart failure, arthropathy, anxiety, and renal failure, among other diagnoses. Resident No. 4 also had severe arthritis, was bed- bound, and a hospice patient. Her medical condition caused her to be in pain. The investigator observed Resident No. 4 on April 23, 2002, at 3:30 p.m., 4:14 p.m., and 5:15 p.m.; on April 24 at 2:30 p.m.; and on April 25 at 8:30 a.m. The investigator observed a dressing change to the pressure sore during which resident No. 4 was moaning and groaning. Around 11:00 a.m. on April 23, the investigator's initial observations were that Resident No. 4 was lying in bed on her back with her mouth opened. She was very thin and was moaning and groaning. During the investigator's initial observations, she was touring with one of the staff nurses and was able to ask the nurse some questions about Resident No. 4's condition and current behavior. The investigator also spoke with the director of nursing regarding Resident No. 4. With regard to Tag F-309, the testimony of the investigator was essentially that the tag was violated because she believed not enough was being done to control the resident’s pain. The director of nursing informed the investigator that Resident No. 4 had some pressure sores and a lot of arthritis, the most severe of which was in her knees and back. Resident No. 4 was prescribed some regular pain medications, as well as pain medications on an as needed basis. The regular pain medication was Oxycontin two times per day with Vicodin, as needed. Oxycontin is a morphine derivative and a very strong narcotic. Vicodin is also a strong narcotic, but not as powerful as Oxycontin. Resident No. 4 had received the Oxycontin as prescribed. In fact, a number of different pain medications had been tried with Resident No. 4 while she was at Brynwood in order to find the most appropriate and effective relief. There was a care plan for Resident No. 4's pain. The investigator testified that during the months of March and April, Vicodin was only given a few times. In April, up until the date of the survey, Vicodin was only given six times. However, the investigator only reviewed the Medication Administration Record (MAR) to determine the amount of medication given to Resident No. 4. She did not review any other medication records. The administration of a narcotic medication can be noted in at least three different places in the resident’s chart: the nursing notes, the MAR, and the controlled drug sheets. As indicated, the investigator checked only the MAR in reaching her conclusion that Vicodin had been given only six times in April. The controlled drug sheets, however, noted that Vicodin was given 18 times in April prior to the conclusion of the survey. While it might have been a documentation error not to note these instances on the MAR as well, the information on the controlled drug sheet is also supported by nursing notes and demonstrates that the pain medication was given. Additionally, in Resident No. 4's case, moaning was not always a sign of pain. The resident moaned anytime she was disturbed--if her covers were moved or her tube feeding was started, or her undergarments were changed. Monitoring of Resident No. 4's condition is repeatedly documented in the nurses’ notes. Other measures were taken by hospice caregivers to provide relief to Resident No. 4, such as playing music. Contrary to suggestion by the investigator that other approaches, such as applying heat or acupressure should have been tried, these methods would not be appropriate for a resident such as Resident No. 4 who has an adverse reaction to any touch or disturbance. Resident No. 4’s family also had expressed concern about the resident being overmedicated, and staff were therefore attuned to this issue and tried to balance the need for pain relief with the possibility of overmedication. The investigator conceded that overmedication could also result in a failure to "maintain the highest practicable" level of functioning. Such overmedication concerns were particularly important given the fact that Resident No. 4 was already taking two very powerful narcotic pain medications. The investigator testified that she cited Tag F-309 as a Class II deficiency because not doing enough to control the resident's pain compromised the resident's ability to maintain, or reach her highest practical level. However, there was no evidence by any medical expert that any further medication or intervention was necessary or appropriate to control Resident No. 4's pain, given the pain medication being taken by Resident No. 4 and her resistance to being touched. Therefore, no violation of Tag F-309 was established by the evidence. With regard to Tag F-314, the investigator’s concerns revolved around an asserted delay in a full dietary assessment upon the resident’s admission on September 21, 2001, and what the investigator perceived to be inadequate monitoring of a pressure sore which she believed developed on September 24, 2001, and became a Stage IV pressure sore by the time of the survey. An assessment of the resident's skin condition was conducted at admission. At the time, the resident received a score of 13, indicating the resident as being a moderate risk for developing pressure sores. Also, an assessment of the resident's dietary needs was done by the dietary manager. Resident no. 4 was placed on a regular diet. At the time, the dietary manager did not have the resident’s height, but lack of this detail was harmless, as the resident was a very tiny and thin person. A regular diet is designed to provide adequate nutrition to persons of a typical size, and smaller persons generally have smaller nutritional requirements. The investigator suggested that because the resident lost approximately three and half pounds, she was undernourished. However, the resident was taking a diuretic which could cause a weight loss of this magnitude. The weight loss did not continue. Given these facts the evidence did not demonstrate that Resident No. 4 was undernourished or that Tag F-314 was violated by the facility by any delay in signing the resident's dietary plan. On September 24, a nurse noted an open area on the resident’s coccyx. The open area was not called a pressure sore and there is no substantial evidence that the open area was a pressure sore. Appropriate treatment of the area was begun immediately. Although the investigator testified that she did not see evidence of the progress of the sore, the treatment sheets clearly reflect that treatments of the open area were given. The last treatment occurred on October 12, 2001, because the area had healed. There was no evidence that the resident's regular diet was insufficient for Resident No. 4 or that the diet contributed to the development of any pressure sore. There was no indication of any other sores or open areas on Resident No. 4 until March, when Resident No. 4 went to the hospital on two occasions. Upon her readmission to Brynwood, it was noted that she had a pressure sore acquired in the hospital. Appropriate treatment was being given to the pressure sore by Brynwood. The wound worsened to a Stage IV pressure sore during her second hospital admission, as documented in the clinical records. The investigator’s concern about Resident No. 4's pressure sore appeared based on the misunderstanding that the pressure sore she had at the time of survey first occurred on September 24 and had existed and deteriorated since that time. Apparently, the investigator overlooked treatment records for the open area and the pressure sore in her review. These records clearly demonstrate that the wound which the resident had at the time of survey was not acquired while at Brynwood and was being treated appropriately by Brynwood. It is standard practice to turn a resident every two hours to prevent development of pressure sores. The investigator felt staff at Brynwood were not turning Resident No. 4 a sufficient number of times because she saw her on her back. The times which the investigator indicated the resident was on her back were: 12:10, 1:00, 4:15, and 5:15 on April 23; 8:30 and 2:30 on April 24; and 8:30 on April 25. These observed instances do not demonstrate a failure to turn and position the resident every two hours, as there was no continuous observation over a two-hour time period. Additionally, there was evidence that the resident could and did reposition herself in bed from her side to her back. The charge in the Administrative Complaint was that Brynwood failed to provide care to prevent a pressure ulcer, not that Brynwood failed to provide care to treat a pressure ulcer. Therefore, the testimony of the investigator regarding instances on which the resident was observed to be on her back, suggesting a failure to turn and position the resident, is irrelevant. Even if the charge had been failure to treat, the evidence presented did not support such charge given the fact that the resident could and did often reposition herself. Given these facts, the evidence did not demonstrate that Tag 314 had been violated by Respondent.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order revising the April 25, 2002, survey report by deleting the deficiencies described under Tag F-309 and Tag F-314 and issuing a Standard rating to Brynwood to replace the previously issued Conditional rating; correcting all other records to reflect the absence of any proven deficiencies at Brynwood during either survey; and dismissing the Administrative Complaint. DONE AND ENTERED this 21st day of February, 2003, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 21st day of February, 2003. COPIES FURNISHED: Joanna Daniels, Esquire Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3408D Tallahassee, Florida 32308 Donna H. Stinson, Esquire Broad & Cassel 215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308
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
The Issue Should the Board of Medicine (the Board) discipline Respondent's license to practice medicine in Florida, based upon an alleged failure in the level of care and treatment of J.P., his patient?
Findings Of Fact STIPULATED FACTS: Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes, and Chapter 458, Florida Statutes. The Respondent, whose address of record is 1834 SW 1st Avenue, Ocala, Florida 34474, was issued license number ME 56306. At all times material to this Complaint, the Respondent was a licensed medical physician within the State of Florida. Respondent specializes in pulmonology. Respondent was Patient J.P.'s attending physician. Respondent ordered a bronchoscopy and specimens that revealed possible Mycobacterium Avium-Intracellulare (MAI). The biopsies revealed signs of granulomalous infection as seen in MAI or tuberculosis (TB). During this (his) hospital stay, Patient J.P. was started on the drug ethambutol at 1600 mg daily. It is the manufacturer's recommendation that the dose of ethambutol, if started at 25 mg per kilogram per day, should be reduced to 15 mg per kilogram per day after 60 days. The infections (infectious disease) specialist saw Patient J.P. in his office on or about July 26, and August 8, 2000 and in his August 18, 2000 letter to Respondent, there was no mention or recommendation for a change in Patient J.P.'s dosage after two months on the ethambutol therapy. Patient J.P. was subsequently seen by the Respondent on October 23, and again on December 27, 2000, when Patient J.P. complained of eye problems. At this later visit Respondent immediately discontinued the ethambutol and referred Patient J.P. to an eye specialist. ADDITIONAL FACTS: Patient J.P.: On May 8, 2000, Patient J.P. was seen at Ocala Lung and Critical Care Associates (Ocala Lung and Critical Care) in Ocala, Florida. This practice is Respondent's Professional Association. The patient had been referred by Dr. Dave Metcalf. On that date the patient was seen by Respondent's associate, Poonan Warman, M.D. According to the note in the patient records for that date, the patient reported a complaint of "cough and cold" with no weight loss. (Petitioner's Exhibit No. 1, page 28) On May 23, 2000, the patient returned to Ocala Lung and Critical Care. Again Dr. Warman saw the patient. A note in the patient's chart describes J.P.'s condition on that date. (Petitioner's Exhibit No. 1, page 35) At that time Dr. Warman concluded that the patient had a mass in his left lung with right lung abscess. Dr. Warman scheduled a bronchoscopy and prescribed mediation. On June 13, 2000, Respondent first say Patient J.P. at Ocala Lung and Critical Care. At that time Respondent made notes in the patient's chart concerning the patient's condition. (Petitioner's Exhibit No. 1, page 49) Respondent assessed the condition as a system in the patient's right upper lobe, possible lung abscess. The note refers to the provision of an antibiotic, a CBC differential and CRP that was ordered. This was a follow- up visit for the bronchoscopy that had been performed by Dr. Warman. Cultures in association with the organism found through the bronchoscopy were pending. At that time Respondent's recommendation to the patient was to continue the antibiotic treatment of Augmentin as well as Clindamycin. The patient was to be seen back in a month's time, according to a typed note within the patient's chart bearing Respondent's signature. (Petitioner's Exhibit No. 1, page 48) In that same typed note it was noted that the bronchoscopy and the biopsy that had also been performed did not reveal malignancy but chronic inflammatory cells had developed. The type-written impression entered in the chart was right upper lobe cavitary lesion, most likely lung abscess. On this date Respondent concluded that the patient had bacterial infection in the lung and the lung abscess. Respondent wanted blood work done to monitor the side effects of the antibiotics being given. Respondent discussed the side effects of the medication with the patient as noted in the written entries in the chart. In relation to the antibiotic medications that were provided to Patient J.P., notes were made on June 14 and 20, 2000, in the patient records maintained by Ocala Lung and Critical Care, commenting on the efforts by the practice to assist Patient J.P. in obtaining those medications from that office and other doctors' offices because of his inability to pay for the medicine. (Petitioner's Exhibit No. 1, page 47) On June 27, 2000, Respondent saw Patient J.P. at the Monroe Regional Medical Center (the Medical Center) in Ocala, Florida, for a medical emergency. The Medical Center is a hospital. At that time the patient's chief complaint was a right-side chest pain. The patient was admitted to the Medical Center by Frank E. Reisner, M.D. The patient had called Respondent's office before his admission. Under the circumstances Respondent was concerned that the patient would not receive adequate treatment as an outpatient. It was recommended that the patient be admitted for inpatient hospital treatment of his lung abscess. On June 27, 2000, the emergency department note in the hospital record refers to the admission of Patient J.P. to the service of Dr. Mishra, an internist at the hospital. (Petitioner's Exhibit No. 1, page 354) Dr. Mishra had also spoken to Patient J.P. and told the patient to come to the hospital. Because the Patient J.P. had a lung abscess problem and had been seen by Respondent in the past, Respondent became responsible for the patient in the hospital upon the request of another physician. Respondent's decision to have the patient remain admitted for treatment of the lung abscess was made the same day the patient arrived at the hospital. Under this arrangement Respondent was the attending physician. On June 28, 2000, after receiving the chart for Patient J.P. from Respondent's office, to review the patient history and based upon results at the hospital that revealed the patient had possible MAI present in bronchial washings from a bronchoscopy performed in the hospital, Respondent decided to consult with Lee Prchal, M.D., who specializes in infectious disease and practices in Ocala, Florida. The reason for the consultation was that Respondent does not treat MAI. Decisions about the appropriateness of treatment for MAI, in Respondent's view, would best be made by a physician specializing in infectious diseases. Respondent did not feel comfortable treating MAI, in that he did not have sufficient knowledge about the condition and its treatment. If Dr. Prchal thought that the patient needed to be treated for MAI, Respondent expected that the other physician would be responsible for the care. With this in mind Respondent did not follow the patient as an attending physician would normally during the patient's stay in the hospital. Nonetheless, Respondent was aware that Patient J.P. had been prescribed ethambutol, also referred to as ethambutol hydrochloride or by the generic drug name Myambutol. Respondent understood that the medication had been prescribed initially in a setting in which it was uncertain whether the patient had a problem with MAI or tuberculosis. Dr. Prchal had written the order for ethambutol given to Patient J.P. in the hospital stay. Dr. Prchal intended to address any MAI with the medication. Dr. Prchal did not write orders for ethambutol upon the patient's discharge, although the patient continued to take the medication. Respondent did not order an initial visual acuity test when Patient J.P. was first prescribed ethambutol in the hospital stay. Dr. Prchal did not order visual testing to establish a baseline while the patient was hospitalized. At no point during the time Patient J.P. was treated with ethambutol did Respondent consider himself responsible in addressing MAI. Respondent did not believe that he had the duty to manage the treatment. He believed that Dr. Prchal was responsible while the patient was in the hospital and upon the patient's discharge. On July 19, 2000, following the Patient J.P.'s discharge from the hospital, Respondent saw the patient again in an office visit. Notes concerning that visit were made. (Petitioner's Exhibit No. 1, page 84) The notes reflect that the patient was doing well, and his cough had improved. Respondent's impression was that the patient had atypical TB and COPD. COPD refers to Chronic Obstructive Pulmonary Disease. At the time it was noted that the patient was advised to keep in touch with HRS for atypical TB. HRS refers to Health and Rehabilitative Services. In actuality, the Marion County Health Department was the health organization that Respondent had in mind. The comment on HRS is in association with an adult clinic in Ocala, Florida. According to a note in the patient record made by a member of Respondent's staff, someone previously had spoken to a person from the Health Department, who said that Patient J.P. did not have tuberculosis. This meant that the TB clinic with the Health Department would not follow his case for tuberculosis, but he could be followed in the adult health clinic for the condition he did have and that clinic should be able to help the patient with needed medication. (Petitioner's Exhibit No. 1, page 47) The adult health clinic is a general clinic affiliated with the Department of Health, and if seen in the general clinic Respondent believed that the patient could be provided needed medications. Patient J.P. had experienced difficulties obtaining needed medication in the past. As before, Respondent did not examine Patient J.P. in relation to visual acuity. The patient offered no complaints about his vision at this visit. On the July 19, 2000 visit Respondent did not consider reducing the ethambutol dosage for Patient J.P. The patient was referred to Dr. Prchal for a visit on July 26, 2000, in relation to MAI. Given the referral to Dr. Prchal, Respondent proceeded on the basis that Dr. Prchal was responsible for treating Patient J.P. for MAI. It was intended that the patient return to see the Respondent on October 23, 2000. Patient J.P. saw Dr. Prchal on July 26, 2000. Following that visit Dr. Prchal wrote the Respondent. The letter was dated August 18, 2000. (Petitioner's Exhibit No. 1, pages 87 and 88) In concluding remarks Dr. Prchal stated in the correspondence: Therefore, at this time, I would recommend continued ethambutol and biaxin for treatment of his MAI. The duration of his clindamycin will require your clinical judgment, but in view of his radiographic changes, it may require further prolonged administration. Respondent's reading of the correspondence was that Dr. Prchal would continue to monitor and be responsible for ethambutol therapy while deferring to Respondent to treat the lung abscess with Clindamycin. On October 23, 2000, Respondent saw Patient J.P. in Respondent's office. Handwritten notes were made by the Respondent during the visit, followed by typewritten notes for the patient's record. (Petitioner's Exhibit No. 1, pages 90 and 91) The patient records refer to the Respondent's perception that Dr. Prchal was treating MAI with multiple antibiotics. The note refers to COPD, lung abscess and MAI. Respondent asked the patient to discontinue Clindamycin and to continue Biaxin. Respondent also asked Patient J.P. to continue taking ethambutol. Respondent did not consider himself to be responsible for treating MAI with ethambutol. In the typed document for the patient record pertaining to the October 23, 2000 visit, it is indicated under the section dealing with Respondent's impression that the lung abscess healed resulting from treatment with clindamycin. At the same time the typed notes indicated that MAI would require long-term treatment. Although Respondent contends that Dr. Prchal would follow Patient J.P. routinely for MAI, the typewritten note describes Dr. Prchal's August 18, 2000 correspondence as a "final note." On October 23, 2000, the patient did not complain of any problems with visual acuity and no eye examination was ordered by Respondent. No specific inquiry was made concerning the patient's progress with the MAI. A follow-up appointment was scheduled for December 27, 2000. Patient J.P. kept that appointment. On December 27, 2000, Patient J.P. complained of an eye problem. He told Respondent that he was not able to see and that two weeks before he had seen an eye physician. As the patient record indicates, the patient complained to Respondent whether this problem with his vision was due to medicine. As a record on the patient care states, authored by Respondent, Respondent indicates "In response, [to complaints about the patient's vision] I have stopped his ethambutol." The impression in the patient record that was typed indicates as well "Ethambutol is being stopped today." This patient record is by way of a letter from Respondent to Dr. Prchal. (Petitioner's Exhibit No. 1, page 93) The letter goes on under the portion referred to as "Plan" to say, "I referred him back to you [Dr. Prchal] for evaluation of the disease process and then we will decide how long he will require the Biaxin." The discussion given thus far of the facts, includes the perspective of the Respondent as to his explanation of care for MAI in Patient J.P. The next part of the discussion is in relation to testimony by deposition by Dr. Prchal including his explanation of his care for MAI provided Patient J.P. Dr. Prchal has practiced in Ocala, Florida, since 1987. His primary specialty is infectious disease. His first encounter with Patient J.P. was at the Medical Center when the patient was referred to him by Respondent, the attending physician, to consult as an infectious disease specialist. When Patient J.P. was first seen, the working differential, as Dr. Prchal recalls it, was that the patient had an underlying chronic lung disease with a history of smoking and a family history of lung cancer. The patient had failed outpatient treatment and when seen could have underlying cancer and/or infections in his lung. Following the bronchoscopy performed on the patient in the hospital, Dr. Prchal wrote an order for ethambutol 1600 mg. The order was written on June 28, 2000. He wanted the patient to receive ethambutol because it was an antibiotic that is used for treating MAI. As Dr. Prchal describes, MAI is a germ in the family of tuberculosis. The patient received his first dose of ethambutol on June 29, 2000. The reason for prescribing 1600 mg of ethambutol was in recognition of the patient's weight. The dosage was presented in four tablets of 400 mg. Dr. Prchal's view of the prescription of ethambutol was that he had signed-off on the case before the patient was discharged from the hospital. At the same time, he considered the use of ethambutol to be open-ended and dependent upon the clinical response by Patient J.P. beyond his discharge. The concluding point for using ethambutol was to be decided by Respondent, in Dr. Prchal's perception, in that Respondent was the attending physician and the main person in charge of the case. Dr. Prchal's view of the choice of dosage of milligrams per kilograms of weight ranging from 15 mg to 25 mg per kilogram of weight, depends upon the person's clinical circumstance. The common starting dose is 25 mg per kg, in his view. Dr. Prchal's experience with ethambutol is that he had prescribed ethambutol to more than 50 patients. Dr. Prchal realized that optic neuritis is a potential side effect in the use of ethambutol. Dr. Prchal does not believe that baseline vision testing is necessary before providing ethambutol therapy. Dr. Prchal is familiar with the PDR concerning ethambutol, which he considers to be the manufacturers guidelines for use of that medication. In relation to the PDR reference to monthly testing for visual acuity during the use of ethambutol, particularly in dosages in the amount of 25 mg per kg, Dr. Prchal refers to the difficulty in having an ophthalmologist see patients for screening in the Ocala area and the difference of opinion among members of the medical community concerning screening. He does not believe that there is a specific standard to be followed in the community for screening. When Patient J.P. was in the hospital receiving his first dosage of ethambutol on June 29, 2000, Dr. Prchal indicated that baseline vision testing was not available in that setting and could only be done following the discharge of the patient. The frequency of testing beyond baseline testing would be on a case by case basis. According to Dr. Prchal, visual monitoring is part of the overall monitoring in the use of ethambutol. In Dr. Prchal's physician progress notes for Patient J.P. made on July 1, 2000, at the hospital, pertaining to ethambutol he referred to "appropriate monitoring." He then goes on to say that he "will sign off." He explains the latter reference to indicate that he was signing-off on the case. (Petitioner's Exhibit No. 1, page 121) Dr. Prchal saw Patient J.P. on July 26, 2000. At that time the patient was continuing with ethambutol. Dr. Prchal inquired about any visual symptoms. Patient J.P. responded that he did not have visual symptoms. The patient told Dr. Prchal that he had been referred to the Marion County Health Department. In Dr. Prchal's opinion the patient's medical condition at the time was better and the medicine seemed to be working. This is taken to mean that the ethambutol was working. Dr. Prchal saw Patient J.P. on August 8, 2000. This was their last visit. As with the visit on July 26, 2000, when Dr. Prchal saw Patient J.P. on August 8, 2000, the patient expressed no complaints about his vision. On August 8, 2000, Dr. Prchal had determined that the patient did not have tuberculosis, and medications to treat that disease were not necessary and could be discontinued. The medications for treating tuberculosis were IMH, Tyrazinamide and Rifampin. Dr. Prchal thought that ethambutol for treating MAI was still called for, together with Biaxin. Dr. Prchal did not have in mind a specific dosage of ethambutol. Being persuaded that Respondent was the attending physician overseeing the care, Dr. Prchal made known his views in the correspondence to Respondent on August 18, 2000. (Petitioner's Exhibit No. 1, pages 87 and 88) Dr. Prchal believes that the reason for Patient J.P.'s visits on July 26, 2000, and August 8, 2000, was Respondent's desire to know what medications still needed to be continued in treating the patient. EYE CARE The day before Patient J.P. saw Respondent on December 27, 2000, the patient had been at Ritz Eye Care. The reason for his visit was "check eyes-has trouble seeing." (Petitioner's Exhibit No. 1, page 192). On the visit to Ritz Eye Care he was seen by Daniel L. Ritz, O.D. Dr. Ritz consulted with Robert N. Mames, M.D., specializing in diseases and surgery of the Vitreous and Retina. Dr. Mames performed an ophthalmic examination and diagnosed the Patient J.P.'s condition as (1) decreased visual acuity in both eyes; (2) minimal nuclear sclerosis; and (3) history of lung abscess, Mycobacterium Avium. In his impression Dr. Mames said "etiologies include optic neuropathy secondary to ethambutol versus CAR syndrome (Canon-associated retinopathy), which is unlikely with no history of cancer." These findings were made in the report from Dr. Mames to Dr. Ritz dated January 16, 2001. (Petitioner's Exhibit No. 1, page 199) Patient J.P. was seen at the University of Florida, College of Medicine, Department of Ophthalmology, on March 23, 2001, by M. Tariq Bhatti, M.D., an assistant professor of the Department of Ophthalmology and Neurology. He indicates in correspondence to Mandouh H. Zeini, M.D., practicing in Ocala, Florida, "It appears that Mr. P. has bilateral optic atrophy. As you are aware, ethambutol is a well-known toxin to the optic nerves. However, I think it would be important to rule out other treatable causes of his optic atrophy. Therefore, I have recommended B-12, folate level, sedimentation rate, syphilis serology, ANA and an MRI of the brain and orbits." (Petitioner's Exhibit No. 1, page 224) On April 25, 2001, Dr. Bhatti saw Patient J.P. again. In turn, he corresponded with Dr. Zeini on that date. (Petitioner's Exhibit No. 1, page 227) With the negative work-up on the prior tests given Patient J.P., Dr. Bhatti wrote, "I suspect Mr. P.'s bilateral optic neuropathies are ethambutol- related. He has discontinued the use of ethambutol, therefore this should remain a static process with no visual loss." PHYSICIAN DESK REFERENCE: MYAMBUTOL The PDR in referring to MYAMBUTOL under the heading DESCRIPTION states: MYAMBUTOL ethambutol hydrochloride is an oral chemo-therapeutic agent which is specifically effective against actively growing micro- organisms of the genus mycobacterium, including M. tuberculosis. In the PDR under the heading INDICATIONS it is stated: MYAMBUTOL is indicated for the treatment of pulmonary tuberculosis. The PDR refers to CONTRAINDICATIONS where it states: MYAMBUTOL is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgment determines that it may be used. Under PRECAUTIONS the PDR states: . . . Because the drug may have adverse effects on vision, physical examination should include ophthalmoscopy, finger perimetry and testing of color discrimination. . . . In relation to ADVERSE REACTIONS the PDR states: MYAMBUTOL may produce decreases in visual acuity which appear to be due to optic neuritis and to be related to dose and duration of treatment. . . . Patients should be advised to report promptly to their physician any change of visual acuity. . . . Testing of visual acuity should be performed before beginning MYAMBUTOL therapy and periodically during drug administration, except that it should be done monthly when a patient is on a dosage of more than 15 mg. per kilogram per day. . . . In relation to INITIAL TREATMENT the PDR states: In patients who have not received previous antituberculosis therapy, administer MYAMBUTOL 15 mg. per kilogram. (7 mg. per pound) of body weight, as a single oral dose once every 24 hours. On the related subject of RETREATMENT the PDR states: In patients that have received previous anti- tuberculosis therapy, administer MYAMBUTOL 25 mgs. Per kilogram (11 mg. per pound) of body weight, as a single oral dose every 24 hours. . . . After 60 days of MYAMBUTOL administration, decrease the dose to 15 mg. per kilogram (7 mg. per pound) of body weight, and administer as a single oral dose every 24 hours. During the period when a patient is on a daily dose of 25 mg/kg monthly eye examinations are advised. EXPERT OPINION TESTIMONY: George Andrews Schoonover, M.D. has been licensed to practice in Florida since 1978. He practices pulmonary medicine in Jacksonville, Florida. He is certified in pulmonary medicine as well as internal medicine and has a sub-specialty in critical care medicine. For proposes of this hearing Dr. Schoonover was recognized as an expert in pulmonary diseases. To prepare himself for testimony at hearing he looked at the materials in Petitioner's Exhibit No. 1, which describes the care and treatment received by Patient J.P. during the relevant period. He also looked at the PDR in relation to MYAMBUTOL (ethambutol hydro-chloride). (Petitioner's Exhibit No. 3) His testimony was offered as a consultant for Petitioner. It supports Petitioner's attempt to impose discipline against Respondent's license. In interpreting the physician's progress note entered by Dr. Prchal on July 1, 2000, while Patient J.P. was in the hospital, which states "would sign off," Dr. Schoonover takes this to mean that Dr. Prchal will not be seeing the patient again, either in the hospital or as an outpatient, unless asked to formally consult at a future date. (Petitioner's Exhibit No. 1, page 121) Patient J.P. was discharged from the hospital on July 5, 2000, by Nagesh Kohli, M.D. Dr. Schoonover points out that the discharge summary explained to the patient in the discharge instructions that the patient, if experiencing any recurrence of symptoms, dyspnea, fever or questions or concerns, may call the Respondent. As well, the discharge instructions note that the patient was to follow up with Dr. Mitra in three to four weeks. (Petitioner's Exhibit No. 1, page 77) This instruction tends to coincide with the patient's visit to Respondent on July 19, 2000. Dr. Schoonover commented on the medications that Patient J.P. would continue upon discharge, in particular ethambutol 1600 mg q.d., part of the discharge summary by Dr. Kohli. This is as distinguished from the ethambutol Dr. Prchal had prescribed earlier in the hospital stay. In a patient medication record for Patient J.P. maintained by Respondent's practice, information is contained concerning ethambutol use over time. (Petitioner's Exhibit No. 1, page 9) Dr. Schoonover refers to the dosage of 400 mg four times per day, on July 19, 2000, October 23, 2000, and December 27, 2000, reflected in the patient record. Based upon the record, Dr. Schoonover assumes that Respondent was aware of the dosage of ethambutol for Patient J.P. upon these dates when the patient was seen, indicating a lack of change in the dosage over time. Dr. Schoonover commented upon the correspondence from Dr. Prchal to Dr. Mitra dated August 18, 2000. In his reading, Dr. Schoonover believes that the correspondence points out that Respondent was the physician of record from the standpoint of monitoring Patient J.P., and in treating the patient from the hospital discharge until the patient was seen by Dr. Prchal on July 26, 2000. In this connection notes made by Dr. Prchal concerning Patient J.P. in August 2000 were interpreted by Dr. Schoonover to indicate that the patient was receiving his prescriptions for medication from Respondent. (Petitioner's Exhibit No. 1, page 270) Dr. Schoonover also mentions the August 30, 2000 note in Patient J.P.'s records maintained by Respondent's practice, which describes a call by Dr. Prchal and his office note, taken to mean the correspondence directed to Respondent on August 18, 2000, in which Dr. Prchal requests Respondent to make sure that the patient has plenty of meds (medication) while Dr. Prchal was out of town through September 18, 2000. (Petitioner's Exhibit No. 1, page 89) That note maintained by Respondent in his practice indicates that the request was honored where it states, "Done." Dr. Schoonover assumes that the reference to meds would include ethambutol. Dr. Schoonover commented on the October 23, 2000 visit with Respondent as reflected in the note made on that date by Respondent (Petitioner's Exhibit No. 1, page 90), wherein it indicates that that patient is being continued on ethambutol. Dr. Schoonover believes that Respondent was responsible for monitoring that therapy and potential side effects and drug interactions associated with ethambutol. Dr. Schoonover commented on the December 27, 2000 correspondence from Respondent to Dr. Prchal, in which Respondent describes the complaint by Patient J.P. made December 26, 2000, about some eye problem, and whether the problem was due to medication. As Dr. Schoonover was aware, Respondent responded to those remarks by stopping the ethambutol. Dr. Schoonover was asked about his ability to form an opinion with a reasonable degree of medical certainty, whether the Respondent by his treatment of Patient J.P. practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. He had an opinion. That opinion was that Respondent deviated from the standard of care, that the Respondent fell below the standard of care. Dr. Schoonover feels that deviation was in two areas. The first was the failure to order eye examinations for Patient J.P. The second reason was that the Respondent did not reduce the dosage of ethambutol after two months of therapy. Dr. Schoonover offered his opinion with the belief that Respondent was the attending physician in the hospital and continued to treat the patient beyond the patient's release from the hospital. Dr. Schoonover indicated that had the Respondent not ordered an initial eye examination be done, then at some subsequent point in the care the examination should have been ordered. Concerning reducing the dosage of ethambutol, Dr. Schoonover further explains his opinion that the dosage should have been reduced by Respondent after 60 days or at least determined why the specialist (Dr. Prchal) had not reduced it after 60 days. Dr. Schoonover concludes that Respondent could have taken steps to prevent the permanent visual impairment of Patient J.P. through an initial eye examination or subsequent follow-up eye examination, finding the problem early enough that this discontinuation of the medication would resolve the problem and promote improvement before permanent damage was done. Dr. Schoonover holds the opinion that Dr. Prchal also deviated from the recognized standard of care in his treatment of Patient J.P. in relation to ethambutol. He believes that both Respondent and Dr. Prchal were in a situation wherein they shared the care and they were both equally responsible and failed to meet the standard of care for the same reasons. In essence Respondent was treating the Patient J.P. for MAI as well as Dr. Prchal. In his testimony Dr. Schoonover is less precise in his opinion concerning the responsibility for a physician to order an initial eye examination for Patient J.P., testifying that it was someone's responsibility. He then goes on to say that it was several persons' responsibility and that Respondent and Dr. Prchal were among those persons. They are the persons discussed as well as Dr. Kohli. Finally, in order to find a deviation from the standard of care by Respondent, Dr. Schoonover believes that it is necessary to show that the patient had diminished visual acuity more probably than not connected to ethambutol. His reading of the April 25, 2001 correspondence from Dr. Bhatti in particular, leads him to believe that there was a connection between the use of ethambutol and bilateral optic neuropathies as described by Dr. Bhatti. (Petitioner's Exhibit No. 1, page 227) Raymond L. Parker, Jr., M.D., has been practicing in Florida since 1976. His current practice is with Pulmonary Physicians of South Florida in South Miami, Florida. He specializes in internal medicine, pulmonary disease and critical care. He is board certified in all specialties. He testified by deposition in behalf of Respondent as an expert, in particular, in relation to his specialty in pulmonary diseases. (Petitioner's Exhibit No. 2) In the deposition the parties stipulated that the witness was an expert in pulmonary diseases. That stipulation is accepted. In preparing to offer his opinion concerning the care provided by Respondent to Patient J.P., Dr. Parker had exposure to the deposition of Respondent, the deposition of Dr. Prchal, the deposition of Dr. Kohli, medical records of Dr. Prchal, Frank's Pharmacy records, medical records of Dr. Leslie Husband, medical records of Beatriz X-Ray and Imaging Center, medical records of Dr. Zeini, medical records of Dr. DiLorenzo, medical records of the Marion County Department of Health, medical records of Express Care of Belleview, and medical records of the Monroe Regional Medical Center. Dr. Parker also had exposure to records related to Patient J.P., part of Respondent's office practice. Dr. Parker comments on the bronchoscopy performed by Respondent on June 29, 2000, while Patient J.P. was in the hospital, in which the bronchoscopic specimen showed no endoscopic evidence of malignancy. Based upon the results of the bronchoscopy in the hospital and an earlier bronchoscopy performed a Dr. Warman on June 7, 2000, Dr. Parker was persuaded that the patient was going to be treated for MAI based upon cultures that grew out from the procedures. Further, Dr. Parker refers to the discharge diagnosis when Patient J.P. left the hospital, where it is stated that the patient had atypical tuberculosis, MAI, in addition to a right-upper lobe abscess and COPD. Dr. Parker's refers to the progress note dated July 1, 2000, when Patient J.P. was in the hospital, made by Dr. Prchal, in which Dr. Prchal recommends 400 mg tablets, four times daily of ethambutol, totaling 1600 mg, as being part of a treatment for TB and MAI pending AFB culture results. Dr. Parker's reading of the note by Dr. Prchal calling for "Appropriate monitoring. Will sign off," in the context of other materials reviewed by Dr. Parker, meant that Patient J.P. was being referred to the tuberculosis health center and those persons in that facility would manage the tuberculosis and MAI issue in the future. Dr. Parker refers to information in the patient records where the wife of Patient J.P. contacted a social worker leading to the patient being informed that the tuberculosis unit did not treat MAI but that an attempt was being made to make an appointment for Patient J.P. to be seen at the adult clinic. Ultimately, Dr. Parker interprets the information he reviewed as indicating that Patient J.P.'s wife decided that an appointment needed to be made with Respondent resulting in the appointment on July 19, 2000, between the patient and Respondent. Between July 1, 2000, when Dr. Prchal wrote his "sign off" note and July 19, 2000, when the patient was seen by Respondent, Dr. Parker expressed the opinion that Respondent and Dr. Kohli were the attending physicians for Patient J.P. The prescription recommendations upon discharge would have been the responsibility of Dr. Kohli because he discharged the patient. According to Dr. Parker this included ethambutol. Dr. Parker is familiar with the PDR. He does not consider it to be an authoritative source for information among doctors. He considers that the information contained in the PDR was written years before. Consequently, it is not authoritative or up to date. Dr. Parker prescribes ethambutol for his patients but rarely. He has a special interest in MAI. He is aware of the recommendations within the PDR pertaining to visual testing and dosage for ethambutol. He considers some of the recommendations for using ethambutol to be controversial. For example, he does not recommend his patients get monthly monitoring for their vision. Instead, he recommends that they watch out for problems. He considers that this approach is the general consensus in the community where he treats patients. Specifically, Dr. Parker does not question the prescription of 25 mg per kg of patient weight for the Patient J.P. when ethambutol was first prescribed. The dosage points to the patient loosing weight, fevers and sweats, not doing well and the need to "jump on him or he would just wither away." Dr. Parker does believe that there should have been an eye test when starting the patient on ethambutol. Dr. Parker in his understanding perceives that when Dr. Kohli discharged the patient from the hospital, Dr. Kohli believed that the patient would be attending the TB Clinic for treatment and monitoring, to include baseline studies for visual acuity. Dr. Parker in his opinion looks upon the suggestion in the PDR that the dosage of ethambutol be changed over time as being a guideline and that the proper treatment is in view of the clinical needs of the patient. If the patient is improving the dosage can be reduced. If he remains very sick, he would not necessarily reduce the dose. Concerning the maintenance of 25 mg per kg over periods of three, four, five, or six months Dr. Parker says that under appropriate circumstances the maintenance of 25 mg per kg of patient weight is acceptable. He does not offer his opinion concerning this case. Concerning the prospect for reducing the dosage, Dr. Parker's review of the records does not lead him to a conclusion one way or the other. When patients are maintained on 25 mg. per kg. of patient weight, Dr. Parker expresses the opinion that more frequent eye testing is in order. If the dosage is less than that amount he would not recommend that a patient have repeat eye testing but that the patient be cautioned to quickly advise the doctor about changes in vision and or visual fields or color vision. From his review of the records Dr. Parker was aware that the patient was maintained on ethambutol 25 mg per kg of weight for approximately six months and no eye tests were provided during that period. Dr. Parker interprets the correspondence from Dr. Prchal to Respondent dated August 18, 2000, as a guiding letter for addressing Patient J.P.'s MAI, leading to the belief by Dr. Parker that Respondent deferred to Dr. Prchal in the treatment of MAI with ethambutol following that correspondence. Overall Dr. Parker does not believe that Respondent was treating Patient J.P. for MAI and had no experience with the drug ethambutol as part of that care. This meant that Dr. Parker does not believe that Respondent was addressing the MAI issue or ethambutol. Dr. Parker interprets the note in Respondent's office practice where on August 30, 2000, the call was received from Dr. Prchal referring to the office note of August 18, 2000, from Dr. Prchal. That request asks that the patient have plenty of meds while Dr. Prchal was out of town until September 18, 2000. This indicates that Dr. Prchal could not write the prescriptions and that he was requesting Respondent's office to handle the writing of prescriptions. This is not seen by Dr. Parker as turning over the management of the patient in reference to the prescriptions. In Dr. Parker's view, when consultants prescribe medication, the attending physician does not have a standard of care obligation to hold the knowledge about these drugs prescribed by the consultant for the patient. The attending physician relies upon the consultant for guidance on the drugs and any questions need to be followed up with the consultant, according to Dr. Parker. In this case he goes on to describe the expectation, upon the discharge from the hospital, that the patient would be seen by a clinic where the attending physician felt there would be necessary expertise. Dr. Parker reached an opinion on standard for care issues concerning Respondent's treatment and care of Patient J.P. His opinion is that Respondent met the standard of care because he was the treating physician limited to the lung abscess and COPD. Dr. Parker interprets the results of the July 19, 2000 visit to Respondent to be one in which Respondent realized that the patient was not going to be seen at a tuberculosis health clinic, resulting in Respondent referring the patient back to Dr. Prchal for management of MAI. Dr. Parker attaches importance to the August 18, 2000 letter from Dr. Prchal to Respondent, in which Dr. Prchal indicates a treatment plan for MAI and Respondent defers to that judgment. At the inception Dr. Parker believes Respondent was acting appropriately to refer Patient J.P. to Dr. Prchal, an infectious disease expert. Concerning the need for a baseline eye examination to be performed when ethambutol is being started, Dr. Parker thinks that is necessary. However, the physician managing the care with respect to the MAI and who ordered the medication is responsible for ordering the initial eye examination. In this case that would have been Dr. Prchal. Any follow-up eye examinations on a periodic basis would be the responsibility of the physician with a special interest in management of atypical mycobacterial disease, with some understanding of the various drugs involved, to include ethambutol. Dr. Parker believes that additional eye examinations are needed when continuing the dosage of 25 mg per kg of patient weight. Given the continuing dosage over time, Dr. Parker believes that Dr. Prchal was responsible for ordering subsequent eye examinations. In relation to the suggestion in the PDR that around 60 days the dosage of ethambutol be reduced, Dr. Parker believes that it is dependent upon the clinical response of the patient. Sometimes the dosage would be reduced earlier, sometimes later. The judgments concerning dosage would be that of the expert familiar with the MAI and drugs used to address it. SUMMARIZING FACTS: Respondent's explanation of the availability of the adult clinic in Ocala, Florida, to address Patient J.P.'s need for medications and other services only establishes that availability. It does not establish what was done at the clinic, if anything, in terms of treatment for MAI through the use of ethambutol and related vision tests. There is no proof that anything transpired at the adult clinic to treat MAI, or test for visual acuity. Whatever may have been offered to the patient in treatment and care by the adult clinic, it does not change the fact that Respondent and Dr. Prchal were involved with the treatment for MAI, to include the need to properly use ethambutol. Having considered the facts found concerning the care provided Patient J.P. by Respondent and Dr. Prchal and the opinions by the parties' experts Dr. Schoonover and Dr. Parker, Respondent has failed to practice medicine with the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Dr. Prchal was responsible for prescribing ethambutol while Patient J.P. was in the hospital. Consequently Dr. Prchal was responsible for testing initial visual acuity for the patient. The initial treatment provided was upon a request to consult made by Respondent. Dr. Prchal was also responsible for establishing the initial dosage for the patient. When the patient was discharged from the hospital, Dr. Prchal was no longer responsible for the treatment from July 5, 2000, the discharge date until July 26, 2000, when called upon again by Respondent to consult. When Dr. Prchal saw Patient J.P. on July 26, 2000, and August 8, 2000, it reestablished his responsibility but only temporarily. The treatment was turned back to Respondent as established in the correspondence following the second consult. That correspondence was dated August 18, 2000, from Dr. Prchal to Respondent involving ethambutol and its use in treating Patient J.P. Respondent had responsibility for Patient J.P. in relation to ethambutol following the patient hospital discharge and upon the visit by Patient J.P. to Respondent's office on July 19, 2000. Respondent briefly deferred to Dr. Prchal as a consultant on July 26, 2000, until he received the correspondence from Dr. Prchal dated August 18, 2000. Beyond that point in time, Respondent was responsible for Patient J.P.'s use of the medication ethambutol. This responsibility was evidenced in the Respondent's transcribed office note dated October 23, 2000, when the Patient J.P. was seen on a follow-up visit. It refers to the final note from Dr. Prchal dated August 18, 2000 and the continuation of ethambutol for the patient. It describes the need for the patient to continue on ethambutol for a year or so. On December 27, 2000, when Patient J.P. was next seen by Respondent in the office, the patient complained of an eye problem. In response Respondent "stopped his ethambutol" as of that day. During the time that Respondent was responsible for Patient J.P., related to the use of ethambutol by that patient, he was expected to make a clinical judgment about the proper dosage, but not necessarily at a two-month interval. There is no indication that he made any judgment. More significantly, given allegations in the Administrative Complaint, Respondent should have arranged periodic testing of visual acuity, while he was responsible for the use of ethambutol in treating Patient J.P., having failed to reduce the dosage from 25 mg per kg of body weight. Respondent's failure to meet the standard of care is not excused by Dr. Prchal's conduct when treating Patient J.P. with ethambutol. Respondent's belief that Dr. Prchal was all together responsible for treating Patient J.P.'s MAI with ethambutol and other medications is not accepted, realizing that to some degree Respondent undertook the treatment whether capable or not. Finally, there was no proof in this record concerning the local Department of Health, adult clinic providing treatment to Patient J.P. for MAI, to include judgment about the dosage of ethambutol and test for visual acuity. Absent such proof the responsibility fell entirely to Respondent and Dr. Prchal at various times. Their stated assumptions concerning the role, if any, played by the Department of Health, adult clinic in treating Patient J.P. without proof are unavailing and create no defense for their conduct. DISCIPLINARY HISTORY In the case of Department of Health, Petitioner vs. Purushottam Mitra, M.D., Respondent, DOH Case No. 1999-58979, a Final Order was entered. This Final Order was based upon a Recommended Order in Department of Health, Board of Medicine, Petitioner vs. Purushottam Mitra, M.D., Respondent, DOAH Case No. 01-2069PL. The Final Order concluded that Respondent had violated Section 458.331(1)(m), Florida Statutes, pertaining to maintenance of patient records justifying a course of treatment for a patient. It imposed an administrative fine amounting to $5,000.00. Respondent was also reprimanded by the Board. (Petitioner's Exhibit No. 4)
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2000), imposing an administrative fine of $10,000.00, and issuing a written reprimand. DONE AND ENTERED this 25th day of February, 2005, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of February, 2005. COPIES FURNISHED: Irving Levine, Esquire Judith Law, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Michael R. D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. Bank of America Center, Suite 1000 Post Office Box 2753 Orlando, Florida 32802-2753 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue At issue in this case is whether the Respondent's license as a physician should be disciplined for alleged violations of Section 458.331(1), Florida Statutes, as set forth in the Administrative Complaint.
Findings Of Fact Petitioner is the state department responsible for regulating the practice of medicine in Florida pursuant to Sections 20.165 and 20.43, and Chapters 456, 458, Florida Statutes. Respondent is Kanwaljit S. Serai, M.D. At all times material to this matter he has been a licensed physician in the State of Florida, having been issued license No. ME 0042038. His last known address on record with Petitioner is 5054 Crawfordville Road, Tallahassee, Florida 32310. Respondent was born and educated in India, receiving his medical and surgical credentials in that country. He came to the United States in 1979. He has been licensed in the State of Florida since 1983. Respondent is Board-certified in the area of family practice. Demerol is a Schedule II narcotic that is indicated for relief of moderate to severe pain. Demerol carries a high potential for abuse or addiction. Dilaudid is a Schedule II narcotic that contains hydromorphone. Hydromorphone is a powerful narcotic analgesic indicated for the relief of moderate to severe pain, and carries a high potential for abuse and addiction. Dilaudid is a heavy- duty painkiller that should only be used in terminal illnesses. Lorcet contains Hydrocodone bitartrate and acetaminophen which, when mixed together, is a Schedule III controlled substance. Lorcet is indicated for the relief of moderate to moderately severe pain. Lorcet has a potential for abuse and addiction. Lortab contains Hydrocodone bitartrate and acetaminophen (Tylenol) which, when mixed together, is a Schedule III controlled substance. Lortab is indicated for the relief of moderate to moderately severe pain. Lortab has a potential for misuse, abuse, dependency, and in the person who is prone to addiction, it can contribute to and accelerate his addiction. Methadone is a Schedule II controlled substance. Methadone is indicated for the relief of severe pain, for detoxification treatment in cases of narcotic addiction, and for the temporary maintenance treatment of narcotic addiction. Methadone can produce drug dependence of the morphine type. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of methadone. Oxycontin contains Oxycodone, a Schedule II controlled substance. Oxycodone is a narcotic analgesic indicated for the relief of moderate to moderately severe pain and carries a high potential for dependency, producing and feeding into the addiction of a person who has an addictive behavior. Percocet contains Oxycodone, a Schedule II controlled substance. Oxycodone is a narcotic analgesic indicated for the relief of moderate to moderately severe pain and carries a high potential for abuse and dependence. Valium contains Diazepam, a Schedule IV controlled substance listed in Chapter 893, Florida Statutes. Diazepam is a benzodiazepine anxiolytic (anti-anxiety drug) and muscle relaxant. The abuse of Diazepam can lead to physical or psychological dependence. Vicodin contains Hydrocodone bitartrate, a Schedule III controlled substance. Hydrocodone is a narcotic analgesic indicated for the relief of moderate to severe pain on a short-term basis. Vicodin is a highly addictive medication. Xanax contains alprazolam, a Schedule IV controlled substance. Alprazolam is a benzodiazepine anxiolytic, and the abuse of alprazolam can lead to physical and psychological dependence. Xanax is indicated for the short-term relief of symptoms of anxiety and is highly addictive. On January 20, 1999, Patient L.D., a 27-year-old female, presented to Respondent at his Family Practice clinic located at 5054 Crawfordville Road, Tallahassee, Florida (Family Practice clinic), with complaints of chronic migraine headaches. Patient L.D. informed Respondent that a neurologist had previously treated her for the headaches through prescription of Lortab 10 mg, 120 tablets per month, and Demerol 100 mg, four injectable per month. Respondent took a minimal history and physical and did not obtain an adequate history regarding Patient L.D.’s substance abuse and her prior experience with narcotic analgesics. Respondent failed to perform a complete neurologic evaluation of Patient L.D. He should have, but did not look in her eyes to see if there was any indication that she may have had swelling in the brain. Also, Respondent should have examined her heart and lungs in regard to possible neurological problems. On January 20, 1999, Respondent prescribed for Patient L.D. Lortab 10 mg, 120 tablets and Demerol 100 mg injectable, without sufficient medical justification. Respondent continued to prescribe these medications through February 1999. On March 8, 1999, Respondent admonished Patient L.D. for obtaining prescriptions from her neurologist, in addition to the prescriptions that she was obtaining from Respondent, but continued Patient L.D. on Lortab and Demerol. On March 11, 1999, Patient L.D. presented to Respondent with multiple symptoms of narcotic withdrawal. Respondent began prescribing Methadone 5 mg, to be taken four at a time, four times a day (80 mg/day) for the migraine headaches. In general, methadone is not an appropriate drug to use for migraine headaches. Methadone is primarily used for cancer patients or drug-addicted patients. Methadone patients have to be monitored carefully and there must be an abundance of documentation detailing: evidence of opioid toxicity; functional status, both physical and psychosocial; and evidence of aberrant behavior, such as escalating the dose or frequent “loss” of prescriptions. Respondent’s medical records do not contain this type of documentation on Patient L.D. Respondent continued to prescribe Methadone in the same amounts from March 11, 1999, through August 2001. Respondent prescribed an excessive and inappropriate amount of Methadone to this patient. In addition, while prescribing the Methadone, Respondent continued prescribing Demerol to Patient L.D. This prescribing practice was inappropriate. Respondent was not monitoring Patient L.D. on a regular basis or attempting to wean her off of Methadone. Respondent prescribed medications in an inappropriate and excessive manner to Patient L.D. Respondent failed to practice medicine within an acceptable standard of care for Patient L.D. in regard to his prescribing practice, his failure to obtain an adequate history and physical, his failure to obtain appropriate tests, and obtain appropriate referrals. Respondent failed to keep medical records that adequately documented the course and scope of treatment for Patient L.D. in regard to his prescription practice, the history and physicals for the patient, as well as the decision to not refer this patient out to the appropriate specialists in pain management and addiction therapy. On May 6, 1999, Patient V.Y., a 30-year-old female presented to Respondent at his Family Practice clinic complaining of abdominal pain and exhibiting hepatomegalia (enlarged liver) secondary to Hepatitis C. Hepatitis C is a chronic disease which rarely causes pain. Patients with Hepatitis C are at-risk for primarily liver cancer, and certainly an enlarged liver that is painful should alert one to the possibility of cancer or other conditions. Without any further history or examination, Respondent prescribed Dilaudid 2 mg, two times a day. On November 17, 1999, Patient V.Y. presented to Respondent with the continued pain. Without further history and only documenting “same” for the diagnosis, Respondent increased Patient V.Y.’s prescription to Dilaudid 4 mg, two times a day, quantity 20. On November 24, 1999, Patient V.Y. presented to Respondent with the continued pain. Without further history and only documenting “same” for the diagnosis, Respondent prescribed Dilaudid 4 mg, two times a day, quantity 20. On December 1, 1999, Patient V.Y. presented to Respondent with continued complaints of pain. Without further history and only documenting “same” for the diagnosis, Respondent prescribed Dilaudid 4 mg, two times a day, quantity 20. Respondent also noted “pending f/u with We Care.” We Care is a clinic in Tallahassee that assists with examinations and tests. On December 8, 1999, Patient V.Y. presented to Respondent with the continued pain. Without further history or examination, Respondent prescribed the normal dosage of Dilaudid and, in addition, prescribed Valium 10 mg, two times a day. The only added note was “stressed out job divorce holidays.” The record also notes that there was no follow-up contact with We Care. On January 5, 2000, Patient V.Y. presented to Respondent again for treatment. Respondent’s notes indicated that We Care rejected the patient without any explanation concerning the rejection. Respondent prescribed Dilaudid 4 mg, quantity 20. On June 23, 2000, Respondent noted in his record that the patient could not cope with a reduction in drugs. Respondent then increased the amount of drugs he prescribed for Patient V.Y., prescribing Dilaudid and Valium with increases in Dilaudid until July 2001. On May 1, 2001, Patient V.Y. was admitted to the Emergency Room of Tallahassee Memorial Hospital (TMH) with an overdose of Dilaudid and Valium. The following notes are contained in TMH’s medical records: ". . .suggest d/c dilaudid for pain control of hepatitis – not indicated and cleared by liver" "She should NOT be on chronic narcotics for hepatitis pain control" "Dilaudid is not indicated for HepC/Cirrhosis especially since it is cleared by the liver." Respondent should have never prescribed Dilaudid and Valium to Patient V.Y. Both Dilaudid and Valium are detoxified through the liver. If the liver is having problems, as was evident with this patient, it was contraindicated to prescribe these drugs to her because her liver was damaged. Respondent did not appropriately treat the Hepatitis C for Patient V.Y. Although Respondent had previously referred Patient V.Y. for a gastroenterology study and for an ultrasound due to her enlarged, painful liver, he did not follow up on this referral or test and simply continued to prescribe the same medication for this patient. During the treatment and care of Respondent for Patient V.Y., Respondent was having a sexual relationship with her. Respondent prescribed medications inappropriately and excessively to Patient V.Y. Respondent did not practice medicine within the acceptable standard of care for Patient V.Y. by his manner of prescribing medication, his incomplete physicals and histories, as well as his inappropriate sexual relationship with the patient. Respondent failed to keep appropriate medical records for Patient V.Y. and failed to adequately document the course and scope of treatment in regard to the prescription practice, his treatment of the Hepatitis C and liver problems, his decision not to seek appropriate referrals, as well as his failure to follow up or order appropriate tests. On May 3, 1999, Patient S.W., a 39-year-old female with a history of a mechanical soft tissue injury of the cervical and lumbar spine with a nine percent permanent impairment rating, presented to Respondent at his Family Practice clinic with back, neck, and head pain. Without rendering a complete history or physical examination, Respondent prescribed Dilaudid 4 mg, quantity 10, along with other medications. On June 1, 1999, Patient S.W. presented to Respondent with the same findings again and Respondent, without rendering a complete history or physical examination, prescribed Lortab 5/500 mg, quantity 15. On December 11, 2000, Patient S.W. presented to Respondent with the same findings. Respondent prescribed Dilaudid and Xanax. Respondent’s notes indicated that the patient did not get the Magnetic Resonance Imaging test (MRI) that he had recommended because her car broke down. On May 3, 2001, Patient S.W. finally presented for an MRI of her back and neck. This test revealed a bulging disc at L5-S1 and one at C6-7. However, these are common findings and were not the source of her pain. Patient S.W. continued to see Respondent until August 2001. During this period of time, Respondent continued to prescribe Dilaudid and Lortab, and began prescribing, along with other medications: Xanax .5 mg with a gradual increase to 1 mg., Lorcet Plus, Percocet 10/650 mg, and Oxycontin 40 mg. Patient S.W. was clinically stable during the treatment and care of Respondent; however, medications were adjusted and changed and increased without adequate explanation. The medications prescribed by Respondent to Patient S.W. were excessive amounts of narcotics for a condition that did not require that much pain medication. Respondent never rendered a complete history or physical examination and did not perform sufficient testing and appropriate referrals on this patient. Respondent should have referred Patient S.W. to a physical therapist and/or pain management center rather than trying to take care of her himself. During the treatment and care of Respondent for Patient S.W., Respondent was having a sexual relationship with her, which Respondent has admitted to in the prehearing stipulation. This relationship was inappropriate and Respondent fell below the applicable standard of care by engaging in this sexual relationship. Respondent prescribed medications inappropriately and excessively to Patient S.W. Respondent did not practice medicine within the acceptable standard of care for Patient S.W. by his manner of prescribing medication, his incomplete physicals and histories as well as his inappropriate sexual relationship with the patient. Respondent failed to keep appropriate medical records for Patient S.W. adequately documenting the course and scope of treatment in regard to his prescription practice, the history and physicals for the patient, as well as the decision to not refer this patient out to the appropriate specialists. On June 10, 1999, Patient J.M., 37-year-old male, presented to Respondent at his Family Practice clinic for a burn on his forearm. Respondent appropriately treated this condition. There is an unsigned note in Respondent’s records dated June 30, 1999, about this patient running a “scam.” The scam apparently involved the patient attempting to get narcotic medications at every clinic in town. Patient J.M. approached the Leon County Sheriff's Office (LCSO) with a tip about Respondent prescribing narcotics without adequate justification. On January 20, 2000, Patient J.M., now an undercover informant with LCSO, presented to Respondent at his Family Practice clinic with a history of a narcotic addition. Without any counseling or a referral, Respondent prescribed Vicodin, quantity 20. On January 26, 2000, Patient J.M. presented to Respondent with the same findings as before. Respondent proceeded to prescribe Vicodin, quantity 20, without any counseling or a referral and despite the prior note dated June 30, 1999. On February 3, 2000, Patient J.M. presented to Respondent with the same findings as before. Respondent proceeded to prescribe Vicodin, quantity 20, without any counseling or a referral and despite the note in his file dated June 30, 1999. On February 19, 2001, Patient J.M. presented to Respondent with a tooth abscess. Respondent treated the problem and prescribed Vicodin for pain. Although Respondent did not violate the standard of care on this visit, the prescribing of Vicodin to a known drug addict was unwise. Respondent did not do a complete history, physical examination, or seek proper testing or consultation of Patient J.M. before prescribing Vicodin. Respondent should have referred Patient J.M. to an addiction specialist. The medical records do not justify prescribing Vicodin to a patient who was already addicted to it. Respondent prescribed medications inappropriately and excessively to Patient J.M. Respondent did not practice medicine within the acceptable standard of care for Patient J.M. by his manner of prescribing medication, his incomplete physicals and histories for each of the visits detailed above except the June 10, 1999, and February 19, 2001 visits. Respondent failed to keep appropriate medical records for Patient J.M. and failed to adequately document and justify the course and scope of treatment accorded to this patient. On February 5, 2000, Officer Butler/Patient L.P., a 31-year-old female and undercover officer with LCSO, completed a brief history and physical form for Respondent. She was there as part of her official duties. On February 24, 2000, Officer Butler/Patient L.P. presented to Respondent at his Family Practice clinic with a history of an addiction to pain pills. There was no nurse present during Respondent's examination of this patient. The extent of the physical examination of Officer Butler/Patient L.P. was that Respondent took a light and made an “S” shape across her face. He lifted her shirt and listened to her heart then took the palm of his hand and rubbed it across her breast, and then checked her abdomen. Respondent then proceeded to kiss this patient. Without further examination or medical history, Respondent noted “Drug dependence” in Officer Butler/Patient L.P.’s medical record and prescribed Vicodin ES, one tablet, three times a day for one week for the patient. On March 9, 2000, Officer Butler/Patient L.P. presented to Respondent for additional Vicodin pills. At this visit, Respondent again checked Officer Butler/Patient L.P.’s heart and lungs and told her to lift her shirt. When she did not lift it high enough, he lifted it higher himself. Officer Butler/Patient L.P. indicated to Respondent that she had received 21 Vicodin off the street the past week. There was no nurse present during this examination. Respondent kissed Officer Butler/Patient L.P. and silently mouthed to Officer Butler/Patient L.P. if she wanted to make love. She did not respond to this message. Respondent then, without a complete history and physical examination, and only indicating “Same” in the patient's medical record, prescribed Vicodin ES, quantity 19. Again, on March 23, 2000, Officer Butler/Patient L.P. presented to Respondent for additional Vicodin pills. She indicated to Respondent that she had received 20 Vicodin off the street during the past week. There was no nurse present during this examination. Respondent inquired about meeting Officer Butler/Patient L.P. outside of the clinic on a personal basis. Again, without a complete history and physical examination, and only indicating “Same” in Officer Butler/Patient L.P.’s medical record, Respondent prescribed Vicodin ES, quantity 20, during this visit. During the time Officer Butler/Patient L.P. was under the treatment and care of Respondent, there was never a referral to a pain management specialist or drug addiction or rehab clinic. Notably, Officer Butler/Patient L.P. presented to Respondent with no alleged chronic pain, only her written statement that she was a drug addict. As a result, Respondent launched into his own self-prescribed treatment plan to reduce Officer Butler/Patient L.P. from her dependency, a task which should be performed under the jurisdiction of a licensed treatment center. Respondent’s medical records for Officer Butler/Patient L.P. included a very limited history and physical, no blood work completed, no prior records, an incomplete history regarding why she was addicted or what brought her to the point of addiction, and no explanation as to why she was drug-dependent. There was no legitimate purpose or justification for prescribing Vicodin to Officer Butler/Patient L.P. Respondent made sexual advances towards Officer Butler/Patient L.P. He inappropriately touched and kissed her. Also, Respondent suggested to Officer Butler/Patient L.P. that they have sex. Respondent has admitted to having a sexual relationship with Officer Butler/Patient L.P. in the prehearing stipulation form. Respondent prescribed medications inappropriately and excessively to Officer Butler/Patient L.P., and did not practice medicine within the acceptable standard of care. This is exemplified in regard to Officer Butler/Patient L.P. by Respondent's manner of prescribing medication, his incomplete physicals and histories, as well as his inappropriate sexual relationship with the patient. Respondent failed to keep medical records that adequately documented the course and scope of treatment for Officer Butler/Patient L.P. This is exemplified by Respondent's prescription practice, the history and physicals for this patient, as well as the decision to not refer this patient out to the appropriate specialists (pain management and addiction specialists). On January 3, 2002, Respondent presented to a Physician Recovery Network (PRN) evaluator as a self-referral. This evaluator was Barbara Stein, M.D. The PRN is the impaired practitioners program for the Board of Medicine, pursuant to Section 456.076, Florida Statutes. PRN is an independent program that monitors the evaluation, care and treatment of impaired healthcare professionals. PRN oversees random drug screens and provides for the exchange of information between the treatment providers, PRN, and the Department for the protection of the public. Raymond M. Pomm, M.D., a Board-certified psychiatrist and addictionologist, is the medical director of the PRN. Dr. Pomm is charged with responsibility for the oversight of the program and documentation of compliance and noncompliance with PRN monitoring contracts. During the evaluation with Dr. Stein, Respondent admitted his inappropriate relationships with Patients V.Y. and S.W. Respondent was advised that a doctor-patient relationship was not being formed and that any conclusions or results from the evaluation would be sent to the PRN. Respondent underwent various tests, including, but not limited to, the Minnesota Multiphasic Personality Inventory-2 and the Millon Clinical Multiaxial Inventory-III tests. Respondent was defensive and did not provide full disclosure of his situation on these tests. The Diagnostic Statistical Manual, Fourth Edition (DSM- IV) is the guidebook that all mental health professionals refer to when they are applying clinical information to criteria, diagnostic criteria, and rendering diagnoses. Utilizing the DSM- IV, Dr. Stein opined that Respondent had antisocial and narcissistic personality traits and could not practice with skill and safety to patients at this time. Dr. Stein opined that, although Respondent does not perceive that he has a problem, Respondent should seek treatment. The treatment should be in an inpatient professional boundary violation program. Then, Respondent should seek outpatient weekly-to-biweekly cognitive behavioral therapy geared towards sexual offenders, professional boundary violators and personality disordered individuals with a licensed PRN-approved provider for at least two years. He should also receive a series of courses on professional boundaries and be re-assessed one year after treatment is initiated to determine whether he is safe to practice medicine. Dr. Stein opined that a PRN contract was premature because Respondent has no conception whatsoever that he has a problem. Following this evaluation by Dr. Stein, Respondent was seen during the period March 13, 2002, to April 5, 2002, by Thomas Hauth, M.D. Dr. Hauth’s final diagnosis for Respondent establishes that there were no diagnoses under any of the Axes, which register psychiatric or psychological problems. Dr Hauth opined that Respondent could return to practice under appropriate treatment. Respondent has seen Mr. Andrew Miller, a licensed social clinical worker, during the period April 10, 2002, through the date of the final hearing. Respondent has been receiving supportive treatment, as opposed to remedial treatment. The PRN is not aware of Respondent’s treatment with Mr. Miller. In addition, Respondent did not comply with any of the other recommendations made by Dr. Stein. Although Respondent sought help from Mr. Miller, he did not contact the PRN to seek approval of this therapy. In fact, after the initial evaluation by Dr. Stein and supplying the report from Dr. Hauth, Respondent had no other dealings with the PRN. Dr. Pomm's testimony also establishes a diagnostic concern regarding Respondent. If there were no diagnoses on Axis I or II, then there is no psychiatric condition and, in the case of Respondent, one is dealing strictly with a predatory sexual violator. Dr. Pomm's testimony further establishes that such an individual should be dealt with in a legal sense without involvement from a psychiatric point of view. Respondent can not practice medicine with skill and safety at this time. Further, he is not an appropriate candidate for the PRN program because of his diagnoses, or lack thereof, and his lack of insight and motivation.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law and the Recommended Range of Penalty under Rule 64B8-8.001(2), Florida Administrative Code, and Aggravating and Mitigating Circumstances under Rule 64B8-8.001(3), Florida Administrative Code, it is RECOMMENDED that the Board enter a final order finding Respondent guilty of the charges set forth in the Administrative Complaint and revoking Respondent’s license. DONE AND ENTERED this 21st day of March, 2003, in Tallahassee, Leon County, Florida. DON W. DAVIS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 21st day of March, 2003. COPIES FURNISHED: Steven R. Andrews, Esquire Andrews & Walker, P.A. 822 North Monroe Street Tallahassee, Florida 32303-6141 John E. Terrel, Esquire Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-3265 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R.S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue This case concerns an administrative complaint brought by the State of Florida, Department of Professional Regulation, against Respondent, charging violations of provisions of Chapter 458, Florida Statutes. In particular, it relates to the treatment of the patient Sandra Gilhousen in the placement of an IUD and in the performance of an abortion. Respondent is also charged with misprescription of a controlled substance, Ionamin, for that patient. Respondent is also charged with misprescription of Ionamin, Demerol and Quaalude for the patient Betty Boling. Finally, Respondent is accused of misprescription of Demerol for the patient Margo Stewart. These allegations are more completely described in the conclusions of law.
Findings Of Fact William J. Lee, M.D., is a physician licensed to practice medicine in the State of Florida according to licensure by the State of Florida, Department of professional Regulation, Board of Medical Examiners, License No. ME012345. At all times relevant to this cause, he has held that license and has practiced general medicine and general surgery at Jacksonville Beach, Florida. Dr. Lee is a graduate of Emory University in 1958 and received an M.D. degree from Emory in 1964. His internship was done at the University of Florida, followed by residency and general surgery at the University of Florida from 1965-1968, which was completed at the Duval Medical Center in Jacksonville, Florida, in 1969. After appropriate service of the subject administrative complaint, Respondent made a timely request for formal hearing pursuant to Subsection 120.57(1), Florida Statutes. SANDRA GILHOUSEN On January 5, 1983, Sandra Gilhousen went to the office of Respondent in Jacksonville Beach, Florida, for purposes of the placement or insertion of an IUD. She filled out a patient history information form to the extent as reflected in a copy of that form found in Petitioner's composite Exhibit No. 5, admitted into evidence. That information included home address, employment status, occupation, phone number and age. No information was given or requested on the subject of her past medical history, other than Dr. Lee asking if she suffered any allergies. During the examination process and the subsequent placement of the IUD, the patient indicated that her menstrual cycle had concluded two or three days before, when in fact, she had missed a normal cycle and had suspicion of being pregnant. When the Respondent placed the IUD, there was some seepage of blood indicating to him that the menstrual cycle had just concluded as the patient had indicated. On the other hand, the uterus was enlarged which was consistent with pregnancy. The uterus was found to be mildly boggy upon the placement of the Intrauterine Device. It was the expectation of the patient that the placement of the IUD would cause her to abort the fetus. No pregnancy test was performed prior to the placement of the IUD and no laboratory work was done. These procedures were not performed, according to Lee, because he believed her when she said she had just concluded menses and she had a healthy appearance. Prior to the placement of the Intrauterine Device, Dr. Lee checked the patient's blood pressure, lungs, masses in the abdominal cavity and for pelvic irregularities. None of the results of these observations were recorded in her records with Dr. Lee. The notations in her record related to the visit simply indicates insertion of IUD and the cost of that service plus the cost of the device. At the conclusion of the procedure, Dr. Lee gave the patient a pamphlet related to the IUD and asked for her to make a return visit to make certain there were no complications. The patient Gilhousen and an acquaintance, Betty Boling, returned to Dr. Lee's office on January 7, 1983. The purpose of the visit was not the return visit contemplated by Dr. Lee related to the IUD. On this occasion, Gilhousen was provided a prescription for Ionamin, a medication which is a controlled substance used for weight control. Prior to being provided this prescription from Dr. Lee for 30 units in 30 milligram amounts, the blood pressure of the patient was taken. A copy of the prescription may be found as Petitioner's Exhibit No. 1, admitted into evidence. At that time, the patient weighed less than on the date of the final hearing in this cause. On the final hearing date, the patient was 5'5" tall and weighed 120 pounds. The patient Gilhousen had been weighed before the prescription was given but the weight is not recorded in her records held by Dr. Lee. No indication whatsoever is made of the prescription of the Ionamin or of any examination given prior to prescribing that substance. Dr. Lee did not do a full-scale examination, more than blood pressure and weight, when he prescribed the Ionamin, because in his mind he had observed the patient through an examination two days before when he placed the IUD. A pregnancy test was performed after January 5, 1983, not by Dr. Lee, and Gilhousen had her pregnancy confirmed. She then requested Dr. Lee to perform an abortion, with the understanding that the procedure would have to be done at the convenience of Dr. Lee, in that she did not wish to pay for that service immediately. Dr. Lee was made aware of the results of the pregnancy test prior to subsequently performing the requested abortion. He expected that he would be able to gain the assistance of Betty Boling when he performed that procedure. After a telephone conversation on the evening of January 14, 1983, Gilhousen went to Dr. Lee's office around 8:30 p.m. for the purpose of having the abortion done. As with the case with the IUD, no written consent was given to have the abortion done. Nonetheless, it was discussed with Dr. Lee and it was the desire of the patient Gilhousen to have the abortion. When Gilhousen arrived, the Respondent was smoking marijuana and asked her if she would be interested in marijuana, hashish or cocaine, which she declined. Dr. Lee was unattended by other staff at this time and throughout the abortion procedure. The patient was taken to a patient examining room and placed on an examining table where the abortion was done by D&C. The room had an operating light, necessary instruments to conclude the procedure, an electrocardiogram, suction devices, epinephrines, IV fluids and emergency drugs. No monitoring equipment was used during the procedure other than checking her blood pressure. Blood pressure had been checked prior to the procedure and Dr. Lee had listened to the patient's heart and lungs and a pelvic examination had been made. The procedure took approximately 40 minutes and the observation was made by Dr. Lee that the pregnancy was in the range of four to five weeks. No pregnancy test or laboratory work was done prior to the termination. Laboratory tests were not done because, according to Dr. Lee, this was Betty Boling's friend who didn't have any money. A pregnancy test was not done because Dr. Lee felt that this was an additional expense not necessary in that he believed the patient when she said that she had been informed of a positive pregnancy test. Missing information through laboratory work included Rh typing and a hemoglobin test. Related to the hemoglobin test, Dr. Lee observed that the patient's outward appearance was acceptable and that the mucous membranes had good color. Dr. Lee recognized the possibility of Rh factor problems in the sense of the mother being negative and the father positive as it might affect the next pregnancy of the patient pertaining to Rh incompatibilities. Again, the Rh testing was not done for financial reasons. Moreover, per Lee, the patient wanted the procedure done on that evening and the patient, as he understood it, did not wish to become pregnant in the future. Being unable to locate Betty Boling to assist, Dr. Lee decided to go forward with the procedure without an attendant being present. The patient was given Valium to calm her nerves and Dr. Lee utilized Stadol and Phenergan for sedation and as analgesic. Through this combination, the patient was placed in a sort of "twilight condition" on a plane which made her unconscious, but not a deep unconscious state. While giving her this medication, he asked her if she felt "sexually aroused." In Petitioner's Exhibit No. 5, the amounts and types of medication are recorded in the patient's chart and it is noted that the D&C was done and tolerated well. It is also noted that the patient was picked up by a friend and the charge of the procedure is given. Ergotamine was given to retract the uterus and minimize bleeding. No other information is recorded in the patient's chart. The patient's recovery from the medications in terms of regaining consciousness took longer than might be expected given the amount of medication. Notwithstanding the patient's slow recovery, Dr. Lee left the patient unattended later in the evening for reason that he felt that she was "ready to go home." After leaving the patient unattended, Respondent tried to gain the assistance of Betty Boling to take her home. Boling did not agree. When Dr. Lee returned to his office, which is also his place of residence, visitors came by and he consumed alcohol with those people. He then left a second time to make purchases at a store and when he returned, a Mr. Hobbs, who was a friend of Gilhousen, had arrived to pick the patient up. Hobbs observed Lee staggering and with slurred speech, indications of intoxication. Hobbs and Dr. Lee took Gilhousen to a car and she left with Hobbs. Gilhousen came back to Dr. Lee's office on January 15, 1983, to pick up her car and asked Dr. Lee if she needed to be prescribed any antibiotics for her post procedural circumstance. He told her that this would not be necessary at present and advised her to monitor her temperature. As reflected in Petitioner's composite Exhibit No. 5, Gilhousen was later seen at Memorial Hospital of Jacksonville related to her post abortion condition and was found to be acceptably recovering. It was noted on the basis of a pelvic sonogram that the abortion had been a success. Dr. Doris Newell Carson, M.D., a board-certified gynecologist and obstetrician, who practices in Jacksonville, Florida, was qualified as an expert and gave her medical opinion on the quality of the Respondent's performance in treating Ms. Gilhousen. Her testimony was premised upon an examination of the medical records of Dr. Lee pertaining to Sandra Gilhousen. Dr. Carson felt that in the insertion of an IUD, that Dr. Lee should have obtained the history of the patient's medical condition with particular emphasis on menstrual period and allergies because of the possibility of allergic reaction being brought about with the placement of the IUD. Physical examination was necessary to include heart, lungs, and abdomen and examination of the position of the uterus. In addition, it was necessary to take the blood pressure of the patient and to have laboratory work done related to hemoglobin, a gonorrhea culture and pap smear. Dr. Carson also felt that it was necessary to determine pregnancy by test, prior to the placement. All of these matters should be recorded in the patient records, per Dr. Carson. In addition, written permission should have been received prior to the placement of that IUD. Any physician who failed to do these things and document them, would have demonstrated less prudence than a reasonably prudent, similar physician. As established in prior facts found, Dr. Lee failed to record any of these matters and failed to obtain necessary medical history and to have necessary testing and laboratory work up envisioned by Dr. Carson. Her opinion as to what is needed for the placement of the IUD in the patient Gilhousen in order to achieve community standards in the place where Dr. Lee practiced is accepted. Based upon her opinion, Dr. Lee is found to have practiced medicine in the placement of that IUD with less care and skill than a reasonably prudent similar physician in his community would have been expected to give. Dr. Carson did not feel that Gilhousen, according to the patient's height and weight, needed Ionamin to control the patient's weight. Ionamin, a controlled substance, is a stimulatory drug which has addictive qualities, from Dr. Carson's understanding. The prescribing of the Ionamin on the information available to Lee was not the act of a prudent, similar physician who might be confronted with the same conditions and circumstances as Dr. Lee was when he prescribed Ionamin for Gilhousen, per Carson. Carson did not feel there was a medically justifiable reason for issuing the prescription of Ionamin. Moreover, Dr. Lee was deficient in the mind of Dr. Carson by not recording the issuance of the prescription in the patient's medical records. Dr. Carson's observations about Ionamin and the quality of Dr. Lee's performance in prescribing Ionamin to Gilhousen on January 7, 1983, are accepted. Dr. Carson was questioned on the matter of the abortion procedure which was performed on January 14, 1983. In giving her opinion, she was made aware of certain hypothetical facts related to the setting, time of day, nonavailability of a medical attendant, Dr. Lee's leaving the patient unattended, Respondent smoking marijuana and the offering of marijuana and other drugs to the patient, in addition to the matters set forth in the patient's record. In Dr. Carson's mind, a complete physical, including blood pressure, would be necessary prior to the termination; laboratory work, to include hemoglobin, to measure the amount of iron in the blood would be necessary; a CG culture and RH typing; and discussion with the patient as to allergies to medications would be necessary. In addition, a pregnancy test prior to termination would be indicated. The physician would also need a medical assistant in attendance and written permission would be necessary prior to the termination of the pregnancy. Dr. Carson would have used a D&E as opposed to D&C for termination of this early pregnancy and would not have used the form of anesthesia chosen by Dr. Lee. Her choice would have been a local block. Her testimony as to the choice of procedures and type of anesthesia does not lead to the conclusion that his choice of technique and anesthesia is below the level of care acceptable for a reasonably prudent, similar physician in the Jacksonville community. In Dr. Carson's opinion, it was inappropriate for Dr. Lee to smoke marijuana on the night of the abortion before conducting that procedure and to offer marijuana, hashish and cocaine to the patient. Dr. Carson felt that it was necessary to monitor blood pressure, and other vital signs related to pulse and respiration, the amount of flow from the site of the abortion and to give medication for pain as needed. Dr. Carson finds the act of leaving the patient unattended an unacceptable performance by Dr. Lee. Dr. Carson also believed that the patient's medical history, laboratory information and observations related to the physical examination should be recorded in the patient records and they were not. Per Dr. Carson, the failure to do those things she described related to the pregnancy termination would constitute substandard care to the patient, as would his use of marijuana and offering of illegal drugs to the patient. With the exception of Dr. Carson's opinions about the abortion technique, D&C, and type of anesthesia, her perception about appropriate care is accepted. By her description, this substandard care is tantamount to failure to provide care that a reasonably prudent, similar physician in a similar circumstance would have provided and Dr. Lee has not been sufficiently prudent in his treatment of Gilhousen on the date of the abortion, as shown in contrasting his performance as reported and Dr. Carson's idea of acceptable performance. BETTY BOLING Betty Boling requested assistance from Dr. Lee to control her weight. This request was made on January 7, 1983. Her blood pressure was checked and her weight taken. No other information was sought from the patient related to her history and no further examination was made of the patient as to her physical condition. Neither of these observations related to blood pressure and weight were recorded in her patient records, a copy of which may be found as Petitioner's composite No. 2, admitted into evidence. Boling was then prescribed 30 units, 30-milligram Ionamin by Dr. Lee. The record in this proceeding is left in the posture that the only basis of knowing the true circumstance of the patient Boling related to the need of weight reduction is her comment that she was overweight when she requested the provision of diet medication. This does not sufficiently justify the prescription of Ionamin and promotes the conclusion, based upon Dr. Carson's perception of the Gilhousen situation where Ionamin was prescribed, that there was no medical justification for prescribing Ionamin to Boling and that to do so was substandard care and not the care expected of a reasonably prudent, similar physician in dealing with the Boling case. (The prescription may be found in Petitioner's Exhibit No. 3.) On July 14, 1981, Dr. Lee prescribed for Betty Boling 30, 50-milligram Demerol units. On August 23, 1981, an additional 20, 50-milligram Demerol units were prescribed for Boling by Lee. On November 1, 1981, an additional 20, 50- milligram Demerol units were prescribed by Dr. Lee for Boling. On December 7 or 8, 1981, an additional 30, 50-milligram Demerol units were prescribed by Dr. Lee for the benefit of Boling. On December 7, 100, 300-milligram Quaaludes were prescribed for Boling by Dr. Lee. Finally, on February 19, 1982, 100 300- milligram units of Quaaludes were prescribed by Dr. Lee. The prescriptions of Demerol and Quaaludes may be found in Petitioner's composite Exhibit No. 3. Prescriptions indicate the basis for prescribing the Demerol was related to pain and the Quaaludes related to sleep. None of these prescriptions or the reason for the prescriptions are indicated in the patient records of Betty Boling, found as part of Petitioner's composite Exhibit No. 2, as a copy. Although Dr. Lee claimed to have conducted a physical examination on the patient before prescribing the Demerol and Quaaludes, that testimony is not believed. Moreover, Dr. Lee has no specific recollection of why he prescribed the Demarol for the patient as to the exact details. Dr. Lee had on occasion prescribed Demerol for migraine headaches for Boling. Dr. Lee indicated that other analgesic medication given for the migraine headaches had not been successful and that was why Demerol was used for the patient Boling. Dr. Lee's indication that he might not have entered the details of the prescription of Demerol and Quaaludes for Boling in her records on the occasions in question because of her concern that other persons who had access to her patient records not see those entries, is not tenable and is not accepted as fact. Especially in view of the fact that Boling does not have any recollection of such a request. Notwithstanding the risk to health in prescribing Quaaludes continually as recognized by Dr. Lee in his testimony at hearing, he prescribed Quaaludes in 100 units and in a further 100 units 70 days thereafter in the strongest dosage available. The methaqualone or Quaaludes were for purposes of assisting Boling in sleeping and the explanation given by Dr. Lee about the possibility of using more than one tablet per day within the 70 days in which the original 100 tablets had been prescribed is not accepted. Dr. Carson, after examining the Boling records, did not find any justification in the records for prescribing Demerol and Quaaludes, in the sense of a medical reason for such prescription. As Dr. Carson identified, Demerol is a narcotic analgesic, equivalent to morphine, with 60 milligrams of Demerol being comparable to 10 milligrams of morphine sulfate. Per Carson, Demerol is a drug highly susceptible to abuse, leading to addiction. For that reason, it is not appropriate for migraine headaches in that migraine headaches are repetitive in nature, thereby promoting greater chance of addiction. Demerol is a very potent respiratory depressant and can have allergic manifestations. Demerol and Quaaludes are Schedule II controlled substances. Quaaludes are a sedative which are used for inducing sleep and might be used for people suffering insomnia. Quaaludes have high potential for addiction and the substance became a street drug and has, since the time of this case, become illegal in the State of Florida. To use Demerol and Quaaludes together, according to Dr. Carson, would potentiate depression, thereby compounding effects of the drugs taken singularly. Dr. Lee's prescription of the Demerol and Quaaludes as described in the Boling circumstance, related herein, in the mind of Carson represented a failure of Lee to practice medicine with a level of care, skill and treatment recognized by reasonably prudent, similar physicians as being acceptable under similar conditions and circumstances and represented malpractice. It also was a prescription of controlled substance in bad faith not within the course of professional practice. These opinions by Dr. Carson, related to the Demerol and Quaaludes, and the practices of Dr. Lee in prescribing the substances for the patient Boling are accepted. MARGO STEWART No testimony was given related to the allegations found in Count Six pertaining to Margo Stewart and that count was abandoned by the prosecution.
