The Issue The issue in this case is whether the alleged deficiency cited in the October 2001 survey report existed and, if so, whether the deficiency is sufficient to support the change in the Aristocrat's licensure status from standard to conditional.
Findings Of Fact The Agency is the state agency responsible for licensing and regulating nursing facilities in the State of Florida under Part II, Chapter 400, Florida Statutes. The Aristocrat (The Aristocrat or facility) is a nursing home located at 10949 Parnu Street, in Naples, Florida, licensed by and subject to regulation by the Agency pursuant to Part II, Chapter 400, Florida Statutes. The Agency conducted an annual survey of The Aristocrat from October 8 through 10, 2001. The results of the survey are summarized in a report known as the 2567 report. The 2567 report identifies each alleged deficiency by reference to a tag number (“Tag”). Each Tag of the 2567 report includes a narrative description of the alleged deficiency and cites the relevant rule or regulation violated thereby. The Tag at issue in this proceeding is Tag F 325. Tag F 325 relates to quality of care and references 42 C.F.R. 483.25(i)(l), which requires that, “[b]ased on a resident’s comprehensive assessment, the facility must ensure that a resident maintains acceptable parameters of nutritional status, such as body weight and protein levels, unless the resident’s clinical condition demonstrates that this is not possible.” The standard in 42 C.F.R. 483.25(i)(1) is made applicable to nursing homes in Florida pursuant to Rule 59A- 4.1288, Florida Administrative Code. The Agency is required to rate the severity of any deficiency pursuant to the classification system outlined in Section 400.23(7), Florida Statutes. The Agency assigned a Class II rating to the deficiency as well as “scope and severity” of G pursuant to federal law. The state classification is at issue in this case. A Class II deficiency is one which “the agency determines has compromised the resident's ability to maintain or reach his or her highest practicable physical, mental, and psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services." Section 400.23(8)(b), Florida Statutes. When the Agency alleges that there is a Class II deficiency, as it did in this case, the Agency may change the facility’s licensure rating from standard to conditional. In accordance with its authority and discretion, based on the alleged Tag F 325 deficiency, the Agency changed The Aristocrat’s nursing home licensure rating from standard to conditional, effective October 10, 2001. During the October survey, an Agency surveyor reviewed the clinical records of six residents at The Aristocrat. The Tag F 325 deficiency was based on the Agency’s findings related to the records of one of those six residents and on interviews with facility staff. In order to protect the privacy of the nursing home resident who is the subject of the alleged deficiency, the Administrative Complaint, the 2567 report, and this Recommended Order refer to the resident by number rather than by name. As a result of the surveyors’ review of the records, the Agency determined that one of the residents, Resident 1, had a weight loss of 7.2 pounds between July 30, 2001, and August 11, 2001. The surveyors’ review of Resident 1’s records further reflected that she had a total weight loss of 13.5 pounds between July 30, 2001, and August 25, 2001. According to the resident’s weight records and nutritional assessment, which listed the resident’s usual body weight as 136 pounds, the surveyors considered the weight loss during the aforementioned periods to be significant. Once the surveyors concluded that Resident 1 had a significant weight loss, the surveyors had to determine whether the resident’s weight loss was avoidable. In making this determination, the surveyors had to determine whether the facility assessed the resident adequately, developed a care plan, implemented the care plan, and reevaluated the care plan. Applying the Agency’s protocol set forth in the above paragraph, the surveyors determined that the significant weight loss experienced by Resident 1 was avoidable. The Agency surveyors found that the facility failed to do the following: adequately assess and develop a plan of care to prevent Resident 1 from significant weight loss; assess and develop an adequate care plan after the resident had a significant weight loss of 5.3 percent of her body weight in less than two weeks; and adequately assess, evaluate and revise the care plan to address the resident’s significant weight loss of 9.9 percent of her body weight in less than a month. According to the 2567 report and the Administrative Complaint, the nutritional parameter that the Agency alleges the facility did not maintain for Resident 1 was weight loss. The Agency was concerned that Resident 1’s weight dropped from 136 pounds on July 30, 2001, to 128.8 pounds on August 11, 2001, which was a 5.3 percent loss of her body weight, upon admission to the facility. Also, the Agency was concerned that the resident’s weight dropped from 136 pounds on July 30, 2001, to 122.5 pounds on August 25, 2001, a 9.9 percent loss of her body weight, upon her admission to the facility. The Agency alleges that the failure to assess and develop an adequate care plan to address weight loss caused the referenced weight loss. Resident 1, a 92-year-old female, was admitted to The Aristocrat on July 30, 2001, at about 3:00 p.m. Her diagnosis included a left hip fracture, left shoulder fracture, atrial fibrillation, esophageal reflux, depression, bipolar disorder, hypertension, and chronic insomnia. John Patrick Lewis, M.D., was Resident 1’s treating physician at the time of and throughout her three-month stay at The Aristocrat. Upon Resident 1’s admission to the facility, Dr. Lewis had “great concern” about the resident’s atrial fibrillation because of her history of T.I.A.s (strokes). As a result of this concern, Dr. Lewis consulted with and reviewed the medical records of Dr. Drew, Resident 1’s primary physician. Resident 1's weight dropped from 136 pounds on July 30, 2001, to 134.8 pounds on July 31, 2001, to 133 pounds on August 4, 2001, to 128.8 pounds on August 11, 2001. Resident 1’s weight began to level off on August 15 or 16, 2001, when edema was no longer noted on her records. Thereafter, beginning on August 19, 2001, the resident’s weight began to stabilize. Resident 1 weighed 124.2 pounds on August 19, 2001; 122.5 pounds on August 25, 2001; 122.7 pounds on September 7, 2001; 121.2 pounds on September 14, 2001; 122.2 pounds on September 21, 2001; 121.6 pounds on September 28, 2001; and was 120.3 pounds on October 6, 2001. Resident 1 came to The Aristocrat days following major surgery of her hip after she suffered a fracture of her hip and shoulder. Resident 1 was hydrated with fluids prior to and/or during the operation to ensure that she maintained a good blood pressure. As a result thereof, at the time Resident 1 was admitted to The Aristocrat, she had an increased amount of fluids in her body and was over-hydrated. The over-hydration caused Resident 1 to have swelling, known as edema. Dr. Lewis testified that Resident 1's edema was actually third space fluids, which are fluids that go extravascularly into the soft tissues or into the peritoneal cavity. It typically takes a period of 7-14 days for that fluid to return to the intravascular compartment and then be urinated away. At the time of her admission at The Aristocrat and throughout her stay there, Resident 1 was on a medication known as Lasix, which is a diuretic that causes the body to urinate excess fluids. Lasix was included in Resident 1’s discharge orders from the hospital where she had surgery for her hip fracture and was never discontinued. In Dr. Lewis’ opinion, there was no need to discontinue the Lasix because the resident was never dehydrated during her stay at The Aristocrat. Moreover, Dr. Lewis is aware that in addition to being a diuretic, Lasix is sometimes prescribed for high blood pressure and this may have been another reason Lasix was included in the resident's discharge orders. The presence of edema in Resident 1 was clearly noted in her chart by facility staff at or near the time she was admitted to the facility. The reference to Resident 1's edema is included in the nurse’s notes dated July 30, 2001, nurse’s notes dated July 31, 2001, a registered dietician's note dated August 1, 2001, and a physical therapy note dated July 31, 2001. The nurse’s notes dated July 30, 2001, the date Resident 1 was admitted to the facility, state that “2 plus edema noted on left upper extremity.” Another document in Resident 1's chart, dated July 31, 2001, states, “2 plus edema on left hip, incision site.” The nutritional assessment dated August 1, 2001, two days after Resident 1 was admitted to the facility, notes edema in lower and upper extremities and “some weight loss expected.” Finally, a dietary note dated August 1, 2001, mentions Resident 1’s edema, but does not mention the location of the edema. The Aristocrat staff did not note Resident 1’s edema on her initial Minimum Data Set form (MDS) as preferred by the Agency. However, the resident’s edema was charted in several places in her records. The Agency’s surveyor acknowledged that Dr. Lewis saw Resident 1 on August 11, 2001, when her weight had dropped from 136 pounds to 128.8 pounds and did not instruct The Aristocrat’s staff to alter their approach to providing adequate nutrition to Resident 1. The reason Dr. Lewis did not order that any changes be made for Resident 1 on August 11, 2001, was that he believed that none were required or necessary in that “the majority of this weight loss was to be expected.” According to Dr. Lewis, “this weight loss [was] not unexpected due to her excessive hydration and third space fluids.” The Agency’s initial concern was Resident 1’s weight loss, during the period of July 30, 2001, through August 11, 2001, when she lost 7.2 pounds, or 5.3 percent of her weight at the time of her admission to the facility. Surveyors are instructed to use a resident’s “usual body weight” to make weight loss calculations. When calculating weight loss, the usual body weight is determined by considering the person’s weight through adult life. According to the state’s guidelines, an analysis of weight loss or gain should be examined in light of the individual’s former life style, as well as current diagnosis. The medical records of Dr. Drew, Resident 1’s primary physician, indicate that Resident 1 weighed 127 pounds on January 31, 2001, and weighed 125 pounds on June 8, 2001. In light of the undisputed fact that Resident 1 was over-hydrated at the time she weighed 136 pounds, it is reasonable to assume that her weight in the months and weeks prior to surgery would be more appropriate figures to use as the resident's usual body weight. Based on her 5'0" height, Resident 1's ideal weight was 100 pounds, the midpoint between the ideal weight range of 90 to 110 pounds for someone five feet tall. In fact, were 136 pounds Resident 1's true weight, she would be considered clinically obese. The Agency surveyor based his calculations that Resident 1 had a significant weight loss on the assumption that the resident’s usual body weight was 136 pounds. The surveyor obtained the 136-pound weight as the resident’s usual body weight from the facility’s nutritional assessment. The Aristocrat incorrectly listed the resident’s weight upon admission, 136 pounds, as her usual body weight. Even if it is assumed that the Agency reasonably relied on the facility’s records that note Resident 1’s usual weight as 136 pounds, the calculations using this weight are flawed because that is not Resident 1’s usual body weight. Had the Agency based its calculations relative to the resident’s weight loss on her usual body weight of 125 pounds, a drop in weight from 125 pounds to any of Resident 1's charted weights would not be “significant” according to surveyor guidelines. One can lose 10 pounds of water weight in just a couple of days but one must burn calories to lose body weight. There are 3,500 calories in a pound. Therefore, in order lose one pound of body mass, a person would need to burn 3,500 calories. Resident 1 lost one pound each day for the first three days she was at The Aristocrat. In order to lose three pounds of body mass, Resident 1 would need to burn 10,500 calories. At the time of her admission to The Aristocrat, Resident 1 was 92 years old and, for the first two weeks she was at the facility, was bed-bound, with a fractured hip and shoulder. Given Resident 1’s condition, it is reasonable to assume that she burned minimal calories. It was physiologically impossible for Resident 1 to lose true body weights in the amounts quoted in the 2567 report. Resident 1 dropped from 136 pounds down to 134.8 pounds the next day and then down to 133 pounds the following day. Because it is impossible to lose a pound of actual body weight in one day, the recorded weight loss for Resident 1 was too rapid to be true weight loss. Rather, the resident's initial weight loss was the result of a decrease in her edema. In determining that Resident 1 had a significant weight loss during the period of July 30 and August 11, 2001, the Agency surveyors based their calculations on an inaccurate usual body weight for the resident. Moreover, the Agency did not consider that the resident had edema and was taking Lasix, a diuretic, and that part of the weight loss could have been water weight. In fact, the 2567 report does not mention that the resident’s chart or records indicate that Resident 1 had edema and that a weight loss could be expected as the edema decreases. The Agency’s explanation for not doing so was that the facility’s records did not indicate or assess the amount of edema Resident 1 had upon her admission. Even though Resident 1 was edematous, the facility staff appropriately addressed her weight issues and immediately began implementing nutritional interventions. There are a number of complex factors at play in the selection and timing of appropriate interventions for a given resident. For example, there is a "warm-up time" to see how a new resident will adjust to the facility. It is not unusual for new residents to experience problems as a result of being in a new environment. However, after a couple of weeks, many of the new residents resolve their relocation issues and adjust to their new environment. During the period of July 30 through August 11, 2001, The Aristocrat’s staff engaged in numerous activities, which assessed Resident 1 from a nutritional standpoint, and immediately implemented interventions to enable her to maintain as much weight as possible. On July 31, 2001, the day after Resident 1 was admitted to the facility, the occupationa1 therapy staff evaluated Resident 1 to determine the level of supervision and set up assistance she needed while eating. On August 1, 2001, two days after Resident 1 was admitted to The Aristocrat, the facility’s registered dietician assessed Resident 1 and, as noted in paragraph 23, above, indicated that some weight loss would be expected as her edema decreased. That same day, the facility’s registered dietician reviewed some of the resident’s lab values that had been taken at the hospital from which Resident 1 had been released and also ordered a multi-vitamin for the resident. On August 2, 2001, the day after the registered dietician completed a nutritional assessment of Resident 1, the facility’s dietary manager met with Resident 1 to assess her food preferences and find out her likes and dislikes. During this meeting, the dietary manager learned that Resident 1 wanted coffee, with four packs of sugar, with all of her meals and a danish at breakfast. The danish is considered a specialty food and is not one usually provided on a daily basis to residents in nursing home facilities such as The Aristocrat. However, upon learning of Resident 1’s food preferences, the facility immediately began providing her with a danish with her breakfast each morning and coffee with four sugars with each meal. The facility’s providing Resident 1 with the foods she requested was an appropriate intervention that honored her preferences. The assessment described in paragraph 42 is consistent with the acceptable industry standard concerning nutritional issues of new residents. That standard requires facilities to analyze the resident for a number of days, determine their food preferences, and see if their nutritional and/or caloric needs can be met through food first. As such, using specialty foods such as a danish and coffee with sugar are appropriate interventions, which honored the resident's preferences. Two additional assessments were performed within a week of Resident 1’s admission to the facility. First, on August 5, 2001, a restorative assessment was completed which addressed Resident 1's ability to use utensils and open her food. The next day, the speech therapy unit of the facility completed a swallowing screening that assessed Resident 1's dysphagia and ability to swallow. Throughout the month of August, including August 11, 2001, and prior thereto, nurse’s notes regularly included information concerning Resident 1’s appetite, food intake, necessary and/or recommended interventions, and other nutritional issues. For example, prior to August 12, 2001, at least two nurse’s notes indicated that Resident 1’s appetite was fair and another nurse’s note indicated that her appetite was poor. Two of the nurse’s notes for this time period indicated that that the resident needed encouragement with oral intake. In addition to the aforementioned interventions implemented by The Aristocrat’s staff during August 2001, Dr. Lewis intervened numerous times with Resident 1. Because Resident 1's room was near the front of the facility, every time Dr. Lewis went into the facility he walked by her room and encouraged her to eat. Dr. Lewis also had numerous conversations with Resident 1's family to have them bring home cooked food that she would enjoy eating. To the extent that Resident 1 did not maintain “acceptable” parameters of nutritional status, the weight loss was attributable to Resident 1's clinical condition and not any failure on the part of The Aristocrat’s staff. In addition to Resident 1's having edema, she had other clinical issues that may have contributed to her weight loss. These clinical conditions involve the resident's behavioral and emotional problems and certain medication that the resident was taking to relieve the pain she was experiencing following her surgery. A person's behavior and emotional problems can have a considerable impact on the resident’s appetite and eating patterns. For example, a person, such as Resident 1, who suffered from depression and a bipolar disorder, may have a low appetite. In this case, Resident 1 suffered from depression and a bipolar disorder. These conditions may likely have been exacerbated by the resident's having to leave the assisted living facility in which she had lived prior to her surgery, going to a hospital for surgery, and, after being released from the hospital, having to be admitted to yet another nursing facility, The Aristocrat. Resident 1 exhibited behavior problems from the beginning of her stay at The Aristocrat, as documented in her records. During the first two weeks that Resident 1 was at the facility, staff of The Aristocrat documented some of the behaviors that the resident was exhibiting. The resident's MDS dated August 8, 2001, and the MDS dated August 13, 2001, indicate that Resident 1 was experiencing mood and behavior problems, on a daily basis, as reflected in her verbal expressions. Resident 1's August 5, 2001, Social Work Assessment Report indicated that Resident 1 made negative statements almost daily and wanted to return to the assisted living facility. The Social Work Assessment Report described the resident's medical conditions that interfered with her relationship skills as "sad mood, melancholy, anxieties, fear, [and] relocation issues." With regard to the resident's relationship involvement patterns, the report indicates that Resident 1 prefers solitude. The Social Work Assessment Report of August 27, 2001, confirmed that Resident 1 made negative statements almost daily and was anxious and angry. The assessment report also noted that Resident 1 was in an unpleasant mood in the morning almost daily, that Resident 1 withdrew from activities almost daily and exhibited reduced social interaction almost daily. The same document indicated that Resident 1 preferred solitude, and demonstrated a sad mood, melancholy, anxieties, fear, and relocation issues. The Behavior/Intervention Monthly Flow Chart Record for August 15 through August 31, 2001, indicates that Resident 1 yelled at staff and was uncooperative. Finally, the care plan priority document for Resident 1 dated August 30, 2001, indicated that her anxiety may be secondary to anger, that her anger was persistent, and that she was verbally abusive to staff. Undoubtedly, Resident 1's behavior and mood could have likely affected and inhibited her appetite, and, thus, contributed to some of the resident's weight loss. Yet, despite the facility’s documentation concerning the resident's behavioral issues, the Agency apparently did not consider either the documentation or the statements by facility staff during the survey that Resident 1's behaviors interfered with some of the attempted nutritional interventions. Another factor that may have contributed to the amount of food Resident 1 ate while at the facility was the medication she was taking. Resident 1 was on a regimen of Darvocet, a narcotic and pain medication, prescribed to help manage the pain she was experiencing as a result of the surgery and/or the hip and left shoulder fracture. Darvocet is a medication that inhibits a person's appetite. In this case, Resident 1 took approximately 30 doses of the narcotic pain reliever Darvocet during the first 10 or 12 days she was at The Aristocrat. Therefore, it is very likely that as a result of Resident 1's taking Darvocet, her appetite was inhibited and she ate less food than she may otherwise have eaten. The Aristocrat’s staff provided numerous interventions for Resident 1 during her first 21 days in the nursing home. They analyzed her weight and food intake through the dietary and nursing units. They offered to assist her with intake and encouraged her to eat. For example, CNA flow sheets for the month of August indicate that food and fluid were offered to Resident 1 approximately 10 times per day, usually five times during the 7-3 shift and five times during the 3-11 shift, every day. This was in addition to her regular meals, specialty foods such as coffee and danish and nutritional supplements. The snacks offered to Resident 1 were foods such as crackers and juice. Staff continually assessed Resident 1's needs and added interventions throughout her stay. A "significant change" MDS was completed on August 13, 2001, which related to Resident 1's percentage of meals eaten and weight loss. On August 14, 2001, The Aristocrat’s staff completed a behavior flow record that addressed Resident 1's uncooperativeness. On or about August 15, 2001, the facility developed a care plan for Resident 1 that included concerns about her weight loss after the initial weight loss due to resident’s loss of "water weight." The nutritional care plan included numerous approaches such as providing increased calories and encouraging intake of diet supplements and fluid. A nursing note of August 16, 2001, indicated that Resident 1's appetite was fair but improved to quite good while a note dated August 20, 2001, indicated that Resident 1 felt she was not getting good food. Staff discussed Resident 1's many dietary dislikes at a weight meeting on August 22, 2001. In order to increase the resident’s caloric intake, the dietary manager added ice cream to Resident 1’s diet at lunch and dinner. On or about August 23, 2001, Dr. Lewis ordered Medpass, a nutritional supplement, for Resident 1. Pursuant to the order, the resident had two 120cc of the supplement daily. Each 120cc of Medpass has 240 calories. Five days later, on August 28, 2001, Dr. Lewis increased the amount of Medpass Resident 1 was to receive from two 120cc of Medpass to four 120cc of Medpass each day. This order was immediately implemented. The goal of the nursing home is to provide 2,000 calories per day to a resident through food. After the first two weeks Resident 1 was at the facility, she consumed an average of 50 percent of her meals, which equaled approximately 1,000 calories per day. In addition, Resident 1 received 300 calories from her daily danish, 240 calories from her coffee with sugar, 300 calories from her daily ice cream, and 480 from Medpass, a nutritional supplement. This equaled an additional 1,020 calories from the “non-diet” portion of her food consumption and exceeded the 1,600 to 1,800 calories per day that Agency believed Resident 1 needed. The number of calories was increased an additional 480 calories, on or about August 28, 2001, after Resident 1 began receiving four 120cc of Medpass. The Agency alleged at hearing that the facility failed to ensure that Resident 1's estimated protein needs were being met. In determining a person's estimated protein needs, it is clinically appropriate to base such needs on the person's ideal weight. In light of that approach, Resident 1 would have needed approximately 59 grams of protein per day. The meal consumption estimates do not reflect whether the resident ate only one food item or a portion of each item. However, given that the resident's diet had approximately 100 grams of protein and that she consumed approximately 50 percent of her diet, it is reasonable to conclude that her protein needs were met. Most of the time Resident 1 was at the facility, she was eating “fair” which is generally considered that she was eating about 50-75 percent of her meals. Given Resident 1's consumption of her 2,000-calorie diet plus supplements, it is reasonable to conclude that she maintained adequate parameters of nutritional status. The Aristocrat’s staff began interventions for Resident 1 from the day she was admitted to the facility. The staff analyzed her needs and provided her with a supplementation of calories by August 1, 2001. Staff continually assessed Resident 1's needs and added additional interventions throughout her stay at the facility. Two of the more aggressive interventions included obtaining a psychological consultation for Resident 1 and ordering an appetite stimulant for her. The Agency indicated that The Aristocrat should have implemented these more aggressive interventions much earlier than it did in order prevent Resident 1 from losing weight. Contrary to this position, it is not likely that these interventions would have prevented the resident’s initial weight loss that occurred between July 30 and August 11, 2001, because the weight loss was water weight. Dr. Lewis waited until September 13, 2001, to order Megace for Resident 1 because he wanted to give other interventions a chance to work. Also, Megace is an appetite stimulant that can cause liver toxicity. Because of the known side effects of Megace, Dr. Lewis used this approach only as a “last-ditch alternative.” With regard to the psychological consultation, the facility delayed this intervention although the staff was aware of and had noted the resident’s behavior problems soon after she was admitted. The consultation was appropriately delayed to give the resident a chance to adjust to her new environment and to first attempt more conservative measures. Moreover, in this case, Dr. Lewis testified that he recalled that, initially, there may have been some opposition from Resident 1's family regarding a psychological consultation. Resident 1 maintained “adequate” nutritional parameters while at The Aristocrat. To the extent that she may not have maintained "adequate" nutritional parameters during the first almost two weeks at the facility, Resident 1's clinical condition made her initial weight loss unavoidable. Signs or symptoms that a person has been nutritionally compromised include the development of pressure sores and malnourishment, dehydration, dull eyes, and/or swollen lips. In this case, Resident 1 did not exhibit any clinical signs of malnourishment, dehydration, or pressure sores. Moreover, Resident 1 suffered no harm as a result of the initial or subsequent weight loss noted in the 2567 report. The Agency’s reason for changing the facility's licensure rating from standard to conditional is based on its conclusion that the weight loss experienced by Resident 1 was avoidable. The Agency's policy is that if there is an avoidable weight loss, there is harm, with or without a determination that there is actual harm to the resident. The credible testimony of Dr. Lewis was that Resident 1 recovered “very successfully from two major fractures, even in the setting of depression and advanced age.” At the end of Resident 1's stay at the facility she was ambulating on her own with a walker and performing some of her own activities of daily living; and after approximately three months in the facility, the resident returned to the assisted living facility where she previously lived.
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 issuing a standard license rating to The Aristocrat and rescinding the conditional license rating. DONE AND ENTERED this 14th day of August, 2002, in Tallahassee, Leon County, Florida. CAROLYN S. HOLIFIELD 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 14th day of August, 2002. COPIES FURNISHED: Virginia A. Daire, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 William Roberts, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Dennis L. Godfrey, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Room 310L St. Petersburg, Florida 33701 Michael S. Howard, Esquire Gallagher & Howard, P.A. Post Office Box 2722 Tampa, Florida 33602-4935
Findings Of Fact The Respondent, Stephen L. Watson, M.D., has been practicing medicine in Lakeland, Florida, since 1945. Since 1950, he has been board-certified in obstetrics and gynecology. Until this case, he has not been the subject of any Board of Medicine disciplinary proceeding. He recently closed his practice of medicine due to his own poor health. The Respondent saw B. D., as a gynecology patient, for the first time in December, 1983. She was 33 years old at the time and was obese, weighing 184 pounds and standing only approximately five feet, four inches. She also had borderline high blood pressure, at 140/90. On the patient's second visit in July, 1984, the Respondent discussed her weight and gave her a book on diet and weight loss entitled, "The Lighter Side of Life, the Doctor's Program that Really Works." He discussed the contents of the book with her, emphasizing certain parts of it. He also prescribed a month's supply of an appetite suppressant called Fastin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient's next visit was a weight conference on January 2, 1987. On this visit the patient weighed 212; her blood pressure was 140/90. The Respondent again discussed weight and diet with the patient and prescribed a month's supply of another appetite suppressant called Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic. Didrex contains the anorectic agent benzphetamine hydrochloride. It is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include some central nervous system stimulation and elevation of blood pressure. Didrex is contraindicated in patients with moderate to severe hypertension, and caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. At the visit on January 2, 1987, it also was arranged that the Respondent would have blood work done on January 6, a pelvic examination on January 7, and another weight conference on January 29, 1987. As often would happen during the long doctor-patient relationship, the patient missed all three appointments and did not request a refill of her medications. The patient's next visit was for another weight conference on February 10, 1987. She had lost 12 pounds (down to 200), and her blood pressure reading was down to 130/88. The Respondent's course of treatment seemed to be effective. The Respondent prescribed another month's supply of Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic. Ten days later, the patient came in complaining of "nerves" after taking her medications. The Respondent discontinued the Didrex and the diuretic and scheduled the patient for another weight conference for March 10, 1987. The patient missed the March 10, 1987, appointment as well as the next two rescheduled appointments, and she did not request a refill of her medications. Finally, the patient kept the third rescheduled appointment for a weight conference, for May 6, 1987. By this time, the patient's weight was back up to 208. Her blood pressure reading was 120/80. The Respondent prescribed a month's supply of another appetite suppressant called Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her weight conference scheduled for June 3, 1987, and did not request a refill of her medications. The patient kept her rescheduled appointment for a weight conference, for June 11, 1987. This time, her weight was back down, to 197, and her blood pressure reading was 120/80. The Respondent's course of treatment seemed to be effective. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient again missed her next scheduled weight conference, for July 9, 1987, and did not request a refill of her medications. The patient kept her rescheduled appointment for a weight conference, for July 13, 1987. This time, her weight was down further, to 187, and her blood pressure reading again was 120/80. The Respondent's course of treatment continued to seem to be effective. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient's next weight conference was on August 17, 1987. Her weight was down a little more, to 183.5, and her blood pressure reading remained at 120/80. The Respondent's course of treatment continued to seem to be effective, although the patient's rate of weight loss was decreasing. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, but discontinued the diuretic apparently due to a bladder problem. The patient missed her next scheduled weight conference, for September 15, 1987, and did not request a refill of her medications. The patient's next rescheduled weight conference was on October 9, 1987. Her weight was up a little, to 184.75. Her blood pressure reading again was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next scheduled weight conference, for November 6, 1987, and did not request a refill of her medications. The patient's next rescheduled weight conference was on December 7, 1987. Her weight was down a little, to 183. Her blood pressure reading again was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next scheduled weight conference, for January 5, 1988, and did not request a refill of her medications. The patient's next rescheduled weight conference was on February 18, 1988. Her weight was up a little, to 187.5. Her blood pressure reading was 130/80. The Respondent prescribed a month's supply of another appetite suppressant called Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. Tenuate Dospan contains the anorectic agent diethylpropion hydrochloride. Like Didrex, it is a sympathomimetic amine with some pharmacologic activity similar to that of the prototype drugs of this class used in obesity, the amphetamines. Actions include some central nervous system stimulation and elevation of blood pressure. It is contraindicated in patients with severe hypertension, and caution is to be exercised in prescribing it for any patient with hypertension. The Respondent did not see the patient again for weight control, or prescribe any more medication, until May 3, 1988, when the patient was seen for bladder problems. Her weight was down a little, to 181.5, and her blood pressure reading was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, but discontinued the diuretic again apparently due to a bladder problem. The patient preferred Tenuate Dospan, and the Respondent changed the prescription to another month's supply of Tenuate Dospan. The patient missed the next two conferences, scheduled for August 8 and rescheduled for August 9, 1988, and did not request a refill of her medications. She did not see the Respondent or get any more medications from him until a weight conference on December 2, 1988. Her weight was up a little, to 185. Her blood pressure reading was 130/80. The Respondent prescribed a month's supply of Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next four scheduled appointments and did not request a refill of her medications. She did not see the Respondent or get any more medications from him until a blood pressure conference on June 28, 1989. Her weight was up significantly, to 200, and her blood pressure reading was up significantly, to 140/100. Although the patient still was relatively young (approximatly 39), and the Respondent believed there was a causal connection between the patient's weight and blood pressure, the Respondent prescribed only a month's supply of Enduron, a medication for hypertension. The patient missed her next two scheduled blood pressure conferences and did not request a refill of her blood pressure medications, or request any other medications. She did not see the Respondent or get any more medications from him until she saw him for blood in the urine on October 3, 1989, and had a urinalysis and conference. At the time, her weight was up a little more, to 203, and her blood pressure reading was 140/90. The Respondent prescribed an antibiotic and, for reasons not apparent from the evidence, a month's supply of a mild antidepressant, called Elavil. On or about October 23, 1989, the patient telephoned for a refill of her Enduron prescription, which was about to run out, and the Respondent prescribed another month's supply. The patient again missed her next weight conference scheduled for October 30, 1989, and did not request any other medications. She did not see the Respondent or get any more medications from him until a rescheduled weight conference on December 11, 1989. By this time her weight was up to 217, and her blood pressure reading was 140/98. The Respondent was aware that amphetamine-like appetite suppressants should be used with caution with patients having moderately high blood pressure, as the patient had by December 11, 1989. But he also continued to believe that there was a causal connection between the patient's weight and blood pressure and that, given the patient's relative youth and the past success with the treatment, it was worth trying appetite suppressants, in conjunction with diet recommendations, to help reduce both the patient's weight and her blood pressure. He prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. (Tenuate is essentially the same drug as Tenuate Dospan but is shorter lasting.) On January 5, 1990, the patient telephoned the Respondent with a complaint of "nerves." The Respondent prescribed another month's supply of Elavil, with authority for two refills. The patient's next weight conference was on January 24, 1990. Her weight was up a little more, to 220, and her blood pressure reading was 160/98. At that point, it seemed that perhaps the Tenuate Dospan was not effective. Although there could be other explanations why the patient was not losing weight, and it was possible that all appetite suppressants had become ineffective, the Respondent decided to switch the patient to Didrex, which seemed to have been effective in the past, and prescribed a month's supply, to be taken in conjunction with the diet recommendations, along with a diuretic. He also changed her blood pressure medication to Wytensin. The patient missed her next weight conference, scheduled for January 31, 1990, and did not request any additional medications. The patient did not see the Respondent again, or get any additional medications from him, until March 21, 1990, when she saw him to get a letter for employment purposes certifying that she was disease-free. Her weight was up to 226, and her blood pressure was 164/96. The Respondent prescribed another month's supply of Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic and another month's supply of Wytensin. The patient did not see the Respondent again, or get any additional medications from him until August 28, 1991, when she saw him to complain of blood in the urine. At this time, her weight was 234, and her blood pressure reading was 140/90. In addition to treating the urine problem, the Respondent prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic and a month's supply of Wytensin. The patient missed her appointment for a pelvic examination on September 5, 1991, and did not see the Respondent, or get any additional medications from him until she went to a weight conference on December 11, 1989. Her weight was 234.5, and her blood pressure reading was 140/94. The Respondent prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. (It is not clear from the evidence why no blood pressure medication was prescribed.) The patient missed her appointment for a pelvic exam on December 17, 1991, and missed scheduled weight conferences for February 10, 11, and 19, 1992. She did not request any additional medications during this time. The patient made her next scheduled appointment on March 16, 1992, when the Respondent discussed her weight, blood pressure and complaint of headaches. Both her weight and her blood pressure were at their highest: weight, 237; blood pressure reading, 150/110. At this point, there was a real question whether the appetite suppressants still were effective in controlling the patient's weight and thereby helping reduce the patient's blood pressure. On the other hand, the patient continued to miss weight conferences and not follow through on the Respondent's instructions, and it was not clear whether the patient ever had followed the Respondent's weight control treatment long enough to give it a fair chance to work. The patient's blood pressure now was moderately to severely high; on the other hand, she still was only about 42 years of age, and her weight still could have been contributing to her high blood pressure. Nonetheless, the Respondent decided to prescribe only Wytensin on March 16; he also scheduled a complete physical for March 20, 1992. On March 20, 1992, the Respondent had the patient undergo a complete physical. Her weight still was 237, and her blood pressure reading was 160/120. He switched her blood pressure medication to Accupril and decided not to prescribe any appetite suppressants at that time. He scheduled the patient for a weight conference on April 3, 1992. On April 3, 1992, the patient's weight still was 237, but her blood pressure reading was 150/110. Although the patient's blood pressure still was moderately to severely high, the Respondent decided to try an appetite suppressant to reduce her weight in the hopes of, together with the blood pressure medication, effecting a lasting reduction in her blood pressure. He prescribed a month's supply of Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. On April 14, 1992, the patient telephoned the Respondent to report that her blood pressure still was up and that she continued to suffer from headaches. The Respondent decided that it was time to refer the patient to a specialist in internal medicine and made an appointment for her. The patient missed her next scheduled weight conference on April 16, 1992, and missed the appointment with the internist which the Respondent had scheduled for her. She never saw the internist. The patient's next appointment was on May 6, 1992. The Respondent discussed the patient's weight and her hypertension. Her weight was 236, and her blood pressure reading was down to 144/100. The Respondent decided to prescribe a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient overdosed on a pain medication (not the appetite suppressant) and was hospitalized on June 4, 1992. She missed the next scheduled weight conference on June 15, 1992. She did not request any additional medications. The patient's next appointment with the Respondent was on June 18, 1992. She weighed 230, and her blood pressure reading was 140/110. The Respondent prescribed only Accupril and an iron supplement. The Respondent only saw the patient once more, on July 17, 1992, for gynecological problems, and referred the patient to a specialist. He did not prescribe any medications. The patient's blood pressure was 130/100. Her weight was not recorded. The evidence does not reflect that the patient, B. D., grew progressively dependent on the appetite suppressants the Respondent prescribed for her. There was no evidence that the patient ever asked for a refill or new prescription early. She often missed scheduled appointments, resulting in gaps of time between prescriptions when the patient presumably had no appetite suppressants available to her. There also were extended periods of time between visits during which time the patient presumably had no appetite suppressants available to her. Some reputable physicians now seriously question the use of appetite suppressants. There is some evidence that patients lose as much weight and maintain as much weight loss without them as with them. The trend in the late 1980s and early 1990s has been to treat patients for obesity with behavior modification (essentially, diet and exercise) only. But there is no evidence that it is below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances to treat patients for obesity by prescribing appetite suppressants in conjunction with diet recommendations. It is true that the Respondent prescribed appetite suppressants for longer periods of time than recommended in the medical and pharmaceutical literature. The literature recommends using appetite suppressants only during the early weeks of a weight reduction program. The reasons are twofold and related: first, the patient generally builds a tolerance to the appetite suppressant, making them less effective; second, the patient can become dependent on them. The goal is to use appetite suppressants to begin reducing caloric intake for initial weight loss, while changing eating habits for long term reduction in caloric intake and weight. The problem confronting the Respondent in this case lay in the nature of the patient's noncompliance. She would begin the program but not follow it or continue with it for long. When she returned to the Respondent after a long hiatus, it was like starting the program over again. The evidence did not prove that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent to repeatedly restart his treatment for obesity, namely by prescribing appetite suppressants in conjunction with diet recommendations. There were occasions when the Respondent prescribed an appetite suppressant when the patient's blood pressure reading was high. According to the medical and pharmaceutical literature and the expert medical testimony, caution should be exercised in prescribing these medications for patients with high blood pressure. But the exercise of that caution is a matter of medical judgment, based on an overall knowledge and understanding of the patient and circumstances involved. Only once, on April 3, 1992, did the Respondent prescribe an appetite suppressant (Tenuate Dospan) when the patient's blood pressure reading was so high (150/110) as to clearly contraindicate the use of the appetite suppressant. On all other occasions, the patient's blood pressure would be considered mildly or moderately high, requiring the Respondent to exercise caution, which he did. In all cases, the Respondent believed that there was a causal connection between the patient's weight and blood pressure and that, given the patient's relative youth and the past success with the treatment, it was worth trying appetite suppressants, in conjunction with diet recommendations, to help reduce both the patient's weight and her blood pressure. Although some physicians would disagree with the Respondent's medical judgments, except for April 3, 1992, it was not proven that the Respondent's medical judgment in this case fell below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. However, it is found that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent to prescribe Tenuate Dospan on April 3, 1992. It was not proven that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent not to refer the patient to a specialist for hypertension before April 14, 1992. The first evidence of severe hypertension appeared on her visit on March 16, 1992. But the Respondent had not seen the patient since December, 1991, due to missed appointments, and it was reasonable at that point for the Respondent not to refer immediately. It could be argued that he should have referred the patient after one of the next two visits, but the delay until April 14, 1992, was fairly short. It was not the Respondent's fault that the patient did not keep the appointment with the specialist which he made for her. It should be noted that the patient does not complain about the level of care and treatment given by the Respondent. Nor is there any evidence that the Respondent's care and treatment harmed the patient. Apparently, while the patient was hospitalized for overdosing on pain medication unrelated to the Respondent's care and treatment, the patient's medical records were brought to the attention of the predecessor of the AHCA, and it appeared to that agency (and to the AHCA) that the Respondent was guilty of worse practice of medicine than ultimately was proven in this case.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order: (1) finding the Respondent guilty of a single violation, on April 3, 1992, of Section 458.331(1)(t), which also resulted in a technical violation of Section 458.331(1)(q), Fla. Stat. (1993); (2) requiring the Respondent to notify the Board or the AHCA if he reopens his practice of medicine; (3) placing the Respondent on probation on appropriate terms in the event the Respondent reopens his practice; and (4) fining the Respondent $500. RECOMMENDED this 15th day of November, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of November, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-2375 To comply with the requirements of Section 120.59(2), Fla. Stat. (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-8. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven. Rejected as not proven. (The Respondent testified.) Accepted but subordinate and unnecessary. Accepted. First sentence, subordinate to facts contrary to those found; second sentence, subordinate to facts found. Rejected as not proven that the patient's hypertension was severe. Otherwise, accepted but subordinate to facts contrary to those found. 14.-19. Accepted and incorporated. Rejected as not proven, except for patients with severe hypertension. First sentence, rejected as not proven. (He believed it permissible because the patient's blood pressure was not stable.) Second sentence, accepted but subordinate to facts contrary to those found. Third sentence, accepted but subordinate to facts contrary to those found, and unnecessary. First sentence, accepted but subordinate to facts contrary to those found. Second sentence, rejected as not proven. Accepted. Subordinate to facts found. Accepted but subordinate to facts contrary to those found. First sentence, accepted but subordinate to facts contrary to those found. Second sentence, rejected as not proven as to Didrex after 1990; otherwise, accepted and incorporated. First sentence, accepted and incorporated. Second sentence, accepted but subordinate to facts contrary to those found, and unnecessary. (The AHCA did not charge inadequate records.) 27.-29. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven. Accepted but subordinate to facts contrary to those found. Accepted and incorporated to the extent not subordinate or unnecessary. (The question is not whether a referral would have been appropriate but rather whether not referring was inappropriate.) Accepted and incorporated. Rejected as not proven that referral was required in 1984 or that the patient's weight and blood pressure did not respond to treatment before 1988. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. (The question is not whether a referral would have been appropriate but rather whether not referring was inappropriate.) Accepted but subordinate and unnecessary. Rejected. They knew it to the extent that it is the same as for an internist. 37.-38. Accepted but subordinate and unnecessary. 39. Rejected as not proven and as contrary to the facts found. Respondent's Proposed Findings of Fact. 1.-4. Accepted and incorporated to the extent not subordinate or unnecessary. 5. Accepted but subordinate and unnecessary. 6.-20. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to the greater weight of the evidence. Accepted but subordinate and unnecessary. 23.-28. Accepted and incorporated to the extent not subordinate or unnecessary. Other than evidence that she may have become nervous on occasion from the appetite suppressants, accepted and incorporated to the extent not subordinate or unnecessary. Accepted. The second occasion is irrelevant, having occurred after the events in issue in this case. The first is accepted and incorporated to the extent not subordinate or unnecessary. 31.-32. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to the greater weight of the evidence. Accepted and incorporated. Accepted but subordinate and unnecessary. 36.-37. Accepted and incorporated. 38.-40. Accepted. Subordinate to facts found. First sentence, accepted and incorporated. Second sentence, accepted but subordinate and unnecessary. Accepted (that it is not necessarily inappropriate) and incorporated. Accepted. First two sentences, incorporated; second, subordinate to facts found. Accepted. Subordinate to facts found. Rejected as to April 3, 1992, as contrary to facts found and to the greater weight of the evidence. Otherwise, accepted but subordinate to facts found. 46.-47. Accepted and incorporated. 48. Rejected as to April 3, 1992, as contrary to facts found and to the greater weight of the evidence. Otherwise, accepted and incorporated. COPIES FURNISHED: Alex D. Barker, Esquire Elaine Lucas, Esquire Agency for Health Care Administration 7960 Arlington Expressway Suite 230 Jacksonville, Florida 32211-7466 John A. Naser, Esquire 1401 South Florida Avenue Suite 201 Lakeland, Florida 33802 Dr. Marm Harris Executive Director, Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Harold D. Lewis, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue The issues in this case concern an administrative complaint placed by the Department of Professional Regulation against Eduardo G. Romero, M.D., Respondent in this cause for his treatment of two patients for weight control. Those patients are D.H., and S.T. who presented herself to Respondent as patient In his treatment of these patients, Respondent, at count one, is said to have violated Section 458.331(1)(t), Florida Statutes, by gross and repeated malpractice or the failure to practice 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. Further, he is said at count two to have violated Section 458.331(1)(q), Florida Statutes, by prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including a controlled substance, other than in the course of the physician's professional practice. A third count in the administrative complaint was dismissed at the commencement of the hearing and is not to be considered. Finally, in the fourth count, Respondent is said to have violated Section 458.331(1)(n), Florida Statutes, by failing to keep written medical records justifying the course of treatment of the patient.
Findings Of Fact Respondent at all times pertinent to the administrative complaint was licensed as a physician by the State of Florida and continues to hold that license at present. In 1985 Respondent discontinued his family medicine practice and started a practice for treating patients for obesity and weight control. He purchased the obesity and weight control practice from a Dr. Scheininger. The obesity and weight control practice was conducted in the area of Jacksonville, Duval County, Florida. As a part of this practice, on occasion, Respondent would treat persons for minimal weight loss who could not be perceived as typical of the patients that he saw in his practice, nor can they be said to have been overweight and certainly not obese. In the conduct of his weight control practice, Respondent had one other person in his employ. That person was Diane Lee Smith, medical assistant. Ms. Smith's duties involved answering the telephone, writing certain basic information on patient's charts, laboratory testing, and the conduct of EKGs, and helping Respondent in his consultations. She also would take blood pressure readings from patients, pulse rates, take their weight and height and certain measurements of the patients' arms, waists, hips and upper thighs. Respondent in his practice would discuss the nature of his diet program, and do a physical examination to include checking pulse, monitoring heart rate and observing the fundi. If the patient upon those basic clinical observations seemed to need a more complete examination, he would order blood tests, urinalysis, and an EKG. In dealing with the patients, he had these patients provide certain information concerning health history, dietary habits and any exercise regimen that the patients participated in. Respondent did not take on the treatment of patients who had significant past medical histories. Respondent would speak to his patients individually and in a group concerning his weight control program. In these conversations he spoke to them about dietary habits, exercise habits and on occasion, would employ medication as a means of assisting in weight control. One of the drugs of choice by the Respondent in his treatment was Phendimetrazine. This is an anorexic that can be, used for a short duration as an appetite suppressant. It has a potential for abuse, but only in the instance when it is over- prescribed does it present the risk of addiction. The patients who used Phendimetrazine could gain a tolerance to it, thereby needing increasing dosages to profit from the pharmacologic effect. That phenomenon develops less quickly than with amphetamines. D.H., who had been a patient of Dr. Scheininger and had received diet pills from him to treat her weight condition, by a means which is not clear in the record, was contacted about further treatment for her weight condition. The lack of clarity concerns the matter of whether the contact was through Dr. Scheininger or Respondent's offices. Nonetheless, she arranged with the Respondent's office for an appointment to address her desire to lose a minimal amount of weight. This appointment was at the instigation of the Department of Professional Regulation, who upon complaint of the activities of Respondent, utilized D.H. as a means of investigation. The appointment took place on February 26, 1986. Her explanation of her reason for being at Respondent's office, as given to Respondent, was to the effect that she felt she needed to employ the assistance of a physician to lose some weight for cosmetic purposes. Certain entries made by Respondent and his assistant, Ms. Smith, concerning the February 26, 1986 visit and a subsequent visit on April 9, 1986, may be found in the Joint Exhibit No. 1 admitted into evidence. It also includes information provided by D.H. in the form of a medical information questionnaire. It includes dietary information as well. In the course of the initial visit of February 26, 1986, Respondent discussed D.H.'s dietary and exercise habits and suggested approaches about diet. D.H. is a woman of five foot two and a half inches tall, whose birthdate is August 18, 1947. At the time of her visit, her weight was somewhere in the range of 117 to 122 pounds. The doctor's office scale showed her to be 122 pounds. Any one of these weights were within the Metropolitan Life Insurance Company tables of what is considered to be normal weight for a woman of this height. On February 26, 1986, in the course of the visit Respondent checked the heart rate and examined the fundi and made records of these observations. No entry was in the record concerning blood pressure. Having considered the testimony it is found that the blood pressure was taken but no medical record was made of that blood pressure reading. No tests were ordered such as EKG, blood sugar, cardiac testing, blood count, urinalysis, liver and kidney studies, nor was the patient given a complete physical examination. These things were not done because Respondent was persuaded that the patient was a person who enjoyed good health and to undertake these steps would be extravagant and unnecessary. In discussion with the patient D.H. the impression was given to the Respondent that the patient had not succeeded in trying to control her weight to her satisfaction by exercise and diet. As a consequence, Respondent decided to prescribe Phendimetrazine. On February 26, 1986, D.H. was given a prescription of 35 mg. tablets, 60 in amount. The exact details of the explanation of the use of this medication by D.H. and its possible side affects is somewhat sketchy. However, enough is known to conclude that the Respondent made some explanation. He did not make a written entry in the medical records of the patient to the effect that he had explained how to use this medication and the possible complications in its use. Neither did he make those entries following his prescribing of Phendimetrazine, 105 mgs., 30 tablets, as a part of the April 9, 1986 visit by D.H. On the April 9, 1986 visit, basically the same procedures were followed in terms of weight which was shown on the chart as 117 pounds, heart rate and on this occasion, blood pressure was recorded. There is a note that the patient D.H. runs three to six miles three times a week. Respondent charged D.H. $50 for each visit. The medication which she obtained was turned over to the Department of Professional Regulation. As part of the Department of Professional Regulation's investigation of the Respondent, it utilized the services of S.T., who presented herself to the Respondent as patient B.B. S.T. is a Jacksonville deputy sheriff. Her visit with the Respondent occurred on April 21, 1986, and followed the basic sequence related to the prior patient D.H. A copy of certain information pertaining to the patient S.T. as kept by the Respondent may be found at Joint Exhibit No. 2, admitted into evidence. It reflects that this patient is five foot five inches tall, and at the time of the visit weight 128-1/2 pounds, which again is within the Metropolitan Life Insurance Company tables of appropriate weight for a woman of that height. Certain measurements were made of her waist, hips, arm and upper thigh, her blood pressure was taken, heart rate and fundi. Information was given by her concerning her health condition and dietary habits. Respondent, through his office, provided dietary information to this patient as with patient D.H. Patient B.B. was a patient who enjoyed good health and who was there to seek the assistance of the Respondent for purpose of losing a few pounds so that her clothes would fit her better, according to her explanation. No evaluative actions were taken other than those items presented in the aforementioned exhibit. As with D.H., Respondent was convinced that no further testing was needed for a patient who, by his clinical observation, appeared healthy. Phendimetrazine was prescribed for this patient in the amount of 105 mgs., 30 tablets. The explanation of the use of this medication was as is described before with the patient D.H. Respondent charged S.T. $50 for the visit. As with D.H., Respondent discussed dietary practices and the need for exercise with S.T. at length. S.T.'s comment to the Respondent was that she had not been able to lose the weight that she desired by her attempts at diet and exercise. In response, Phendimetrazine was prescribed to aid in this attempt. The Phendimetrazine for the two patients was not only prescribed by Respondent, it was dispensed by him. In addition to Respondent's testimony about the propriety of his treatment of the two patients, several other physicians, who are licensed in Florida offered their opinions. Dr. Stanley Weiss, who is a Board Certified Bariatric Physician testified for the Petitioner. Dr. Samuel J. Alford, Jr. and Dr. Kenneth Lasseter offered testimony for the Respondent. Dr. Weiss indicated that he does not consider the need for cosmetic weight loss to be a medical problem per se. In addition, he stated that he would not have taken on the treatment of D.H. and S.T. who did not have medical problems. Dr. Weiss in a significant portion of his practice treats patients who clearly suffer from problems of obesity. Consequently, when he gives the opinion that in every case of weight control a battery of tests involving EKG, blood sugar, cardiac testing, blood count, urinalysis, liver and kidney studies and a complete physical should be pursued, he is referring to a class of patients different from the patients in this case, by the history of Dr. Weiss' practice. In essence, Dr. Weiss is stating that it was inappropriate for the Respondent to take on the patients and treat them when the patients did not need medical attention and at the same time is stating that a series of tests should have been employed which are common to the treatment of the truly obese patient. This runs contrary to the opinion of the Respondent and of Drs. Alford and Lasseter who do not feel that the tests were in order for persons who by clinical observation, seem to be healthy. The opinion of the Respondent and Drs. Alford and Lasseter concerning the necessity of testing is the more appropriate choice on this occasion and it was not a violation of community standards or failure to practice medicine with reasonable care for the Respondent to fail to conduct the tests that have been alluded to in the rendition of facts. Dr. Weiss believes it was violative of community standards and failure to practice medicine at an acceptable level for Respondent to prescribe Phendimetrazine for the two patients in the instances set out in these facts. The use of Phendimetrazine, according to Dr. Weiss, for these patients who were not obese, is a failure to appropriately prescribe medication. His opinion is accepted. Respondent and Drs. Alford and Lasseter believe that the use of Phendimetrazine for the two patients was appropriate. Their opinion is not accepted. The fact that the two patients indicated that they had not achieved success by diet and exercise does not alter the impression of the facts and deference being paid to Dr. Weiss on the issue of the use of Phendimetrazine. It was not inappropriate for Respondent to consult with the patients D.H. and S.T. about their perceived problems. It was inappropriate to prescribe Phendimetrazine to gain a cosmetic result in an instance where there was no medical reason to utilize that legend drug. This fact is as supported by remarks of Dr. Weiss. Dr. Weiss is critical of the Respondent's medical records, in that they do not note that Respondent explained the possible side effects of the use of Phendimetrazine, and as they are lacking in an explanation of the ongoing or continuing care and in the absence of the aforementioned tests that Dr. Weiss would have conducted on the patients. That latter circumstance is not so much a failure to keep records as an allegation of failure to practice. If the tests were not done, it is to be expected that no record would have been made of the tests. Moreover, the tests were not indicated. Respondent and Drs. Alford and Lasseter do not find Respondent's recordkeeping to be inadequate. Having considered the issue of the need to record side effects or to put more information in the record concerning ongoing and continuing care, it suffices that some explanation of side effects was made and it is not necessary to make a written indication that the explanation was given to the patients. The general nature of the care and treatment of the patients is known by reference to the records. The only failure of recordkeeping which is significant is the failure to have recorded the blood pressure reading on D.H. in her visit of February 26, 1986. This constitutes a failure to keep a written medical record of an examination result.
Recommendation Based upon the findings of fact and conclusions of law reached, it is RECOMMENDED: That a Final Order be entered which dismisses Count III, and finds the Respondent guilty of violations as alleged in Counts I, II and IV, for which, in keeping width disciplinary guidelines, his license shall be suspended for a period of 30 days and he shall be directed to attend at least 21 continuing medical education course credits concerning appropriate drug prescribing unrelated to requirements for license renewal. DONE and ENTERED this 18th day of August, 1989, in Tallahassee, Leon County, Florida. CHARLES C. ADAMS Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of August, 1989. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 87-5055 The following discussion is given concerning the proposed facts of the parties: Petitioner' s Facts Subordinate to facts found. Accepted with the exception that reference to the necessity of conducting various tests is contrary to facts found. Not necessary to the resolution of the dispute. Subordinate to facts found. Contrary to facts found. Subordinate to facts found. Respondent' s Facts 1.-16. Subordinate to facts found. 17,18. Are not accepted to the extent of indicating that D.H. only went there for purposes of diet pills and presented herself as only wanting diet pills is contrary to facts found, otherwise they are acceptable. 19.-21. Subordinate to facts found. Constitutes the reasoning which Respondent would have trier of fact employ to arrive at facts and is not fact finding, with exception of reference to the fact that there is no notation in the chart that D.H.'s blood pressure was taken on February 26, 1986. Same response as prior paragraph. 24,25 Subordinate to facts found. 26. Unacceptable. 27.-41. Subordinate to facts found. 42. Not necessary in its first sentence and the second sentence is contrary to facts found. 43.-46. Constitute a discussion of the testimony and not fact finding. The overall conclusions of these physicians has been reported in the fact finding in the Recommended Order. 47. Further discussion of the opinion of the witness, Dr. Weiss, and is not fact finding. The balance of that paragraph deals with the claim that the Respondent instructed the patients to return in one week which is not accepted. Nor is the conjecture of what the patient S.T. intended to do on her visit to the Respondent. Finally, the remarks attributable to Dr. Alford are again the discussion of the testimony and not fact finding. 48,49. Subordinate to facts found. COPIES FURNISHED: Joseph Harrison, Esquire Department of Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Harold M. Braxton, Esquire 9100 south Dadeland Boulevard One Datran Center, Suite, 406 Miami, Florida 33156-7815 Kenneth D. Easley, Esquire Department of Professional Regulation 1940 North Monroe Tallahassee, Florida 32399-0792 Dorothy Faircloth, Executive Director Florida Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0735
