The Issue Whether Respondent committed the violations alleged in the Amended Administrative Complaint and, if so, what penalty should be imposed.
Findings Of Fact AHCA is the agency responsible for the licensing and regulation of assisted living facilities in Florida pursuant to chapters 429 and 408, Part II, Florida Statutes. At all times material hereto, Kipling Manor was licensed by AHCA as an assisted living facility. Kipling Manor is located in Pensacola, Florida, and operates a 65-bed facility, license number 7285, and holds a specialty limited health license. Norma Endress is a registered nurse employed by AHCA. She conducts surveys of nursing homes and assisted living facilities for compliance. Ms. Endress is supervised by Patricia McIntire, a nurse consultant supervisor for AHCA. Ms. McIntyre has been with AHCA for 13 years. Belie Williams is the administrator of Kipling Manor. He has been involved with health care services for approximately 35 years, and has been an administrator of ALFs for approximately 15 years. He has been involved with the Florida Assisted Living Association (FALA) and served on its board. Mr. Williams helped implement training sessions for ALFs in conjunction with FALA for the past eight years. Kipling Manor has two nurses who visit the facility to provide care to the residents. Elizabeth McCormick is an advanced nurse practitioner (ARNP) in family, psychiatric and mental health. She has been a nurse since 1983 and has extensive experience dealing with inpatient and outpatient psychiatric residents in long-term facilities. Nurse McCormick works with a VA facility providing inpatient and outpatient care on a high intensity psychiatric unit. She was also an assistant professor at the University of West Florida in the Mental Health Nursing Program. Nurse McCormick provides medical and mental healthcare for residents at several ALFs in Pensacola, including Kipling Manor. She sees patients at Kipling Manor several times a month. She manages the healthcare of residents, diagnoses illnesses, and writes prescriptions as needed. She describes Kipling Manor as not being a typical setting because her patients there are seriously mentally ill, which presents huge challenges. Angela Lavigne is a registered nurse certified by Medicare to provide psychiatric care to patients. She is employed by a company called Senior Care. Among other things, she works with assisted living facilities providing therapeutic counseling, assisting doctors with adjusting medication, and providing in-service training to staff of these facilities in regard to psychiatric care. Nurse Lavigne has been seeing patients at Kipling Manor for almost three years. She visits Kipling Manor approximately four times a week. At the time of the survey, she visited the facility once or twice a week. She provides patient care as well as in-service training to the staff regarding psychiatric issues. She also runs group sessions with the residents to make them feel more independent and feel more like they are in their homes. On July 12 through 14, 2011, Nurse Endress conducted an unannounced complaint survey of Kipling Manor that gave rise to the Amended Administrative Complaint and to this proceeding. Count I--Resident 8 Count I alleges that Kipling Manor failed to provide incontinent care for Resident 8 and failed to provide nail and facial care for Resident 6. Ms. Endress observed Resident 8 walking with a "med tech" to the "med room" to receive her medications. Ms. Endress observed wetness on Resident 8's clothes, and noticed the smell of urine. The med tech gave Resident 8 her medications, then assisted her to an open area where Resident 8 sat down. Ms. Endress observed Resident 8 for about two hours. Ms. Endress approached a personal care assistant (PCA), who was a new employee, and inquired of the PCA as to whether the resident was incontinent. As a result of this inquiry, Ms. Endress believed that this resident was incontinent. After approximately two hours had passed, Ms. Endress called this to the attention of the PCA, who then changed Resident 8 immediately. Ms. Endress determined that Respondent was "not providing care for this lady, incontinent care. They were not monitoring her." This determination was based in large part on her belief that Resident 8 was incontinent. However, Resident 8's health assessment indicates that Resident 8 needed supervision while toileting, but did not carry a diagnosis of incontinence. Ms. Endress acknowledged at hearing that supervision with toileting is not the same thing as being diagnosed with incontinence. Resident 8's health assessment also reflects diagnoses of personality disorder, dementia, and Alzheimer's among other conditions. Ms. McCormick provided health care services to Resident 8. She quite frequently is involved with residents who have toileting issues. Had Resident 8 developed skin problems because of toileting issues, she would have been aware of it. Ms. McCormick noted that the records indicated that Resident 8 received a skin cream three times a day to prevent such skin problems. Both Ms. Endress and Ms. McCormick are of the opinion that, while it is better to change a resident as soon as possible, a two-hour check is appropriate for someone with toileting issues. According to Ms. McCormick, if she were looking to determine whether there existed a direct physical threat to Resident 8, there would be monitoring for skin breakdown, redness or irritation, or a possible urinary tract infection (UTI). Neither Ms. McCormick nor Ms. Lavigne were notified or saw any signs of a skin infection, other skin problems, or a UTI regarding Resident 8. There was no evidence presented that Resident had any skin problems or UTI as a result of this incident or her toileting issues. Erica Crenshaw is a "med tech" and a supervisor employed by Kipling Manor. She provided care for Resident 8 and was on duty the days of the survey in question. Ms. Crenshaw verified that Resident 8 was on a two-hour check at the time of the survey. This involved checking to see if Resident 8 was wet or dry. If she were found to be wet, staff would take off the resident's brief, change and wipe the resident, put on a new brief noting the date and time, as well as recording the staff person's initials. When changing Resident 8, staff would apply a barrier cream, and check to see if any bed sores developed. Ms. Endress determined that this was a Class II violation because of the potential for skin breakdown and infection as well as potential for emotional harm, in that she perceived this as a dignity issue for Resident 8. Ms. Endress based this opinion in large part on her mistaken belief that Resident 8 was incontinent. Her supervisor, Ms. McIntyre, reviewed the classification recommended by Ms. Endress and concurred that Class II was appropriate because "[r]esidents, in particular elderly residents, left sitting in urine, there is a great potential for them to experience skin breakdowns, which would certainly have a severe negative impact on their physical health." Mr. Williams saw Resident 8 while Ms. Endress was conducting her inspection. He saw that she was wet from urine on the back of her clothes. He did not detect any strong odor of urine although he was close to her. Count I--Resident 6 Count I also includes allegations regarding Resident Ms. Endress observed Resident 6 with long facial hair (Resident 6 is female) and long, dirty fingernails. Ms. Endress interviewed Resident 6 regarding these observations. Based upon this interview, Ms. Endress believed that staff did not cut her facial hair or trim her nails, despite Resident 6 wanting them to do so. Ms. Endress estimated Resident 6's nails to be approximately one-quarter inch long but could not recall the length of her facial hair. Resident 6's health assessment reflects a diagnosis of dementia with poor short term memory, and that she needs assistance bathing, dressing, and grooming. Erica Crenshaw described Resident 6 as "a little difficult to work with." Staff works on nails, hands and feet, two days a week. If at first Resident 6 was resistant to having her nails trimmed, they would "give her space" then approach her again later. She described Resident 6's nails as "pretty decent." Resident 6 received health care from both Ms. Lavigne and Ms. McCormick. Both nurses are of the opinion that staff worked with Resident 6 to keep her nails in good shape. As a resident of an ALF, Ms. McCormick noted that Resident 6 had the right to refuse nail care and decide whether her nails needed to be trimmed. Ms. Lavigne informed staff that they needed to work with Resident 6 at her own pace, and to be careful not to make her combative. Ms. Lavigne treated Resident 6 for a wrist problem in mid-summer of 2011, when Resident 6 was in a splint for approximately six weeks, and received physical therapy. She described Resident 6's nails as "nice, round, nothing broken, nothing chipped. Every once in a while she's actually let staff put nail polish on them but as far as cutting them down, it's like an act of Congress to get her to sit down enough to trim them." There is no evidence as to what could have been under Resident 6's nails when Ms. Endress saw her. However, the evidence establishes that Resident 6's nails were tended to by staff on a regular basis, and that her treating nurse was not aware of any problem with them. Regarding facial hair, Ms. Lavigne never noticed any facial hair on Resident 6 other than having "a couple little whiskers here and there." Ms. Lavigne was Resident 6's treating nurse in the general time-period around the survey in question, and was never informed about any problems with Resident 6 regarding nails or facial hair, nor noticed any. Ms. Endress classified the findings she made regarding Resident 6's nails and hair as a Class II violation because she perceived it as a "dignity issue because women do not like facial hair on them." Ms. McIntyre confirmed the class determined by Ms. Endress, although the record is not clear why. Count II--cleanliness and maintenance Count II of the Amended Administrative Complaint alleges that Kipling Manor failed to honor the rights of residents by not providing a safe and decent living environment to prevent the spread of disease for all residents. The Amended Administrative Complaint alleges in pertinent part as follows: In an interview resident #3 on 7/12/11 at 9:00 am stated this place was not clean. He stated the cook will have gloves on his hands when he leaves the kitchen. The cook continues rolling the food down the hallway to the dining room while simultaneously rolling the open garbage container which is soiled. Without changing his gloves he will serve the food to the residents.1/ An observation of lunch on 7/12/11 at 12:00 pm revealed the cook serving turkey with gloved hands not using a utensil. Without changing his gloves he handled silver ware, moved a gallon of milk and was touching the dining room table. He was using the same gloved hand to serve corn bread. While serving food he never changed his gloves between clean and dirty. Other staff wearing gloves were serving lunch to residents and cleaning tables and pouring beverages without changing gloves. They were serving beverages touching the rims of glasses without changing clothes [sic]. During the survey, the following was seen: Bathroom floor for room 9 on wing 1 was dirty with build-up of dirt in the corners. Lounge area at the end of wing 1 had a broken recliner that was being used by a resident. The floor and furniture were soiled. Room and bathroom #3 on wing 1 had dirty floors with build-up of dirt along baseboards and the toilet lid was too small for the tank. Vents were clogged with dust. The door was too short for the opening; wood was missing on door frame and the threshold had broken tile. Dining room bathroom at the end of wing 2 had dirty floors with build-up of dirt along baseboards; around bottom of the toilet was black and the seal was cracked. Dining room floors were dirty and walls had dried food on them. Room 27 had filthy floors with build up along baseboards; dried spills were noted and the drywall had a hole in it. Wing 2 had drywall that was pulling away from ceiling and the ceiling had brown water spots: soiled dirty walls; dirty baseboards with build up of dust; spills on walls and vents dusty. Wing 2 had no baseboard near the shower; the cabinet had mildew on the outside surface; the wood was warped and peeling. The sink was soiled with dried brown substance. The door to the cabinet would not close. The baseboard wood near sink was split and the drywall had an indentation of the door knob. Room 21 floors were filthy and smelled of urine. Soiled clothes laid on the floor with soiled underwear which were observed while medication technician was assisting resident. No action was taken by the medication technician. Laundry room floors were filthy. There was no division between clean clothes and dirty clothes. Clothes were lying on the floor.2/ Based upon this complaint, Ms. Endress observed the dining room during a meal and toured the building. At hearing, Ms. Endress acknowledged that she did not see the cook touch the garbage pail or garbage and then touch food. She maintained, however, that she observed the cook while wearing gloves, touch food then touch "dirty surfaces," then go back and touch food on plates and touch the rims on glasses. Ms. Endress did not specify at hearing what she meant by "dirty surfaces," but in her report which was the basis for the Amended Administrative Complaint, she noted that the cook would touch food and then touch surfaces such as moving a gallon of milk, touching the dining room table, and handling silver ware. She also testified that she saw other staff wearing gloves who were serving residents, cleaning tables, and serving beverages without changing their gloves. Deborah Jackson is a personal care assistant (PCA), food server, and laundry worker at Kipling Manor. Ms. Jackson and one other PCA serve meals for about 60 residents. She received training in food service. She was working at Kipling Manor the days Ms. Endress was there for the survey. Ms. Jackson always wears gloves when serving the residents. If she touches anything besides food she changes gloves. For example, if she moves chairs, she changes gloves before resuming food service. She has never seen the other PCA touch other items then serve food. She was trained never to touch the rims of the glasses but to pick up glasses and cups from the side. She goes through "probably a whole box" of gloves in a day. According to Ms. Jackson, the cook stands behind the area and puts the food on the plates, preparing two plates at a time. She watches him prepare the plates of food. She and the other PCA then serve the food to the residents. The garbage can is kept in the back, not where food is being served. She has never seen the cook touch the garbage can then prepare plates of food. When he has finished, he takes all "his stuff" out on a cart, while the PCAs clean up. If a resident spilled food, the PCAs, not the cook, would clean it up. L.N. was the cook at the time of the survey inspection. L.N. was hired in April 2011 and received training in infectious control and food service sanitation. L.N. no longer works for Kipling Manor.3/ Billie Williams, as administrator of Kipling Manor, confirmed Ms. Jackson's description of the cook's role in serving dinner. That is, that the cook prepared plates of food and the PCAs then served the residents. At hearing, Ms. Endress essentially reiterated her findings regarding the other allegations in count II dealing with the cleanliness and condition of the facility. No further proof was offered regarding these or any other allegations in the Amended Administrative Complaint. Mr. Williams' testimony contradicted much of what Ms. Endress described regarding the cleanliness and condition of the facility. Specifically, Mr. Williams noted that on the day of the survey inspection, maintenance men were repairing a ceiling leak. The ceiling leak was the cause of the "drywall pulling away from the ceiling" and the "brown water spots" on the ceiling cited in the Amended Administrative Complaint. These conditions were the result of the water leak and were in the process of being repaired at the time of the survey. The workers arrived early in the morning and cut drywall from the ceiling where the water dripped down on it. They necessarily used a ladder to do the ceiling repair work. A maintenance man stood at the bottom of the ladder and, if a resident approached, would escort the resident around the ladder. Regarding the issues of cleanliness, Mr. Williams has two housekeepers, a person who does the laundry, and two maintenance men. Mr. Williams acknowledged that there may be a small wax buildup along baseboards or on the inside corner of a door. However, the two maintenance men wax, strip, and buff the floors throughout the building. The floors are swept and buffed every day. The baseboards (wall to floor) are dust mopped twice a day. Regarding the allegation that there was black around the bottom of the toilet and the seal was cracked in the bathroom off the dining room area, Mr. Williams went to that room with the maintenance men to personally inspect it. He observed some discoloration on the floor where the toilet may have overflowed at some time and got underneath the tile. The maintenance men cleaned this immediately and replaced the tile. Regarding the allegation that there was mildew on a bathroom cabinet, Mr. Williams inspected the black mark and found it to be a tire mark from a wheelchair. He found no mold or mildew. The black mark was removed. There is a separate laundry room where washers and dryers are located. Any clothes on the floor are for sorting or separating by color or other reason prior to washing. Once clothes are washed, they are taken back to the residents' rooms immediately. Clean sheets, towels, and wash cloths are placed on wooden shelves that were built for that purpose. There is no evidence that establishes that clean and dirty clothes were mixed on the floor. Mr. Williams also inspected the recliner. The recliner has snap-on armrests and one had been snapped off. The maintenance men snapped the armrest back on the chair, and it was easily repaired. Regarding the allegation that the drywall in a bathroom had an indentation of the door knob, Mr. Williams inspected that and found that the doorstop on the bottom had broken off. There was an indentation in the wall the size of a doorknob where the door had been opened hard. This was repaired by the maintenance men. Regarding the allegation of vents being clogged with dust in a room and bathroom, Mr. Williams found "a little" dust on a vent which was cleaned immediately by staff. He then instructed staff to check the vents daily for dust build-up. Mr. Williams could not find a door that was too short for the opening, and noted that this would be a fire code violation. Kipling Manor is current on fire and health safety inspections. In general response to the allegations regarding cleanliness and maintenance and to a question asking whether he keeps a well-maintained building, Mr. Williams stated: We try our best. I mean, I have--you know, when you have incontinent residents who are demented, who are bipolar or suffering from depression, they will do things. And, yes, they do. And like, I think in one of the reports she wrote up, there was wet clothes on the floor. Well, if a resident, some of them are semi-independent, too. I mean, they take care of their own needs. If they had an incontinent issue that morning, and they took their clothes off and left it there on the floor, you know, they expect the staff to pick it up and take it to a laundry room when they come through. You know, we do, I think, we do a darn good job given the -- a lot of my residents have been homeless, have never had any structured living. Nobody else in town takes them, but I have. Ms. Endress classified the alleged violations in Count II as Class II "because of the potential for harm to residents which could occur from an unsafe environment and potential spread of infection." Ms. McIntyre agreed with Ms. Endress that "the totality of all the findings are what drove the deficiency to be considered a Class II." Count III--Resident 4 medications Count III alleges that Kipling Manor failed to administer medications according to the medication observation record (MOR) for 1 out of 9 sampled residents (Resident 4). During lunch, Ms. Endress observed Resident 4 become agitated, rub his face, and complain loudly in the dining room. Following an observation of this resident and a conversation with him, Ms. Endress reviewed Resident 4's medication observation record (MOR) and health assessment. Ms. Endress determined that Resident 4 had not been given one of his medications, Interferon, when scheduled. The MOR shows a time for administration as 8 a.m. According to Ms. Endress, on the date this took place, July 12, 2011, the MOR was blank in the box that should be initialed when the medication was administered. The MOR in evidence, however, reflects initials in that box (i.e., it is not blank). When a drug is self-administered, the staff member initials the box for that day. Erica Crenshaw recognized and identified the initials in the box for that day as those of former unit manager Tekara Levine, who trained Ms. Crenshaw. According to Mr. Williams, Ms. Levine, was certified in the self- administration of medications and was a trustworthy employee. Ms. Endress observed Resident 4 wheel himself from the dining room to the medication room and self-administer his medication. This occurred around noon that day. Ms. Endress determined this to be a Class II violation as she believed it directly threatened the resident emotionally. She based this in part on the resident's demeanor before the medication and afterwards, and the comments the resident made to her. Resident 4 is one of Nurse Lavigne's patients. Resident 4 has a diagnosis of MS, major depression, post traumatic stress disorder, a paranoid psychosis, and anxiety and affective disorder. He receives Interferon for his MS. It is injectable and he self-administers it every other day. According to Nurse Lavigne, there is no doctor's order stating that the Interferon must be given at 8 a.m. or any other particular time. The injection can be administered at any time during the day. Resident 4 sometimes gets confused about his medications. He gets extremely upset if he thinks he has not gotten his medications. He will sometimes tell her (Nurse Lavigne) that he did not receive a particular medication when he, in fact, did receive it. Once he is shown the MOR indicating that he has received his medication, he visibly calms down. He does not like to leave his room because he thinks somebody is changing stations on his TV. Regarding his once-a- day medications, staff will wait until he is ready to come out of his room because he can get agitated. He sometimes gets upset if there are a lot of people around him, such as in the dining room. Nurse Lavigne does a full assessment when she sees Resident 4. She was not aware of any problems with Resident 4 during that time period regarding his medications. While the record is unclear as to why Resident 4's MOR shows an administration time of 8 a.m., the evidence established, through Nurse Levine, his treating nurse, that there is no doctor's order requiring that the drug be administered at that particular time. The evidence also established that Resident 4 self-administered his medication at noon on July 14, and that this was initialed by a staff member on his MOR. Count IV--Resident 1 medications As a result of a complaint received, Ms. Endress interviewed residents about their medications and spoke to a new staff member. Based upon these interviews, Ms. Endress determined that one of Resident 1's medications (Flexeril) had not been available for one dose on July 13, 2011, and another of this resident's medications (Visteril) had not been available from June 23 until July 12, 2011). Ms. Endress classified this alleged violation as a Class II because she determined that that it directly affected the resident psychologically and physically. Resident 1 had a diagnosis of COPD and has an anxiety disorder. She is alert and oriented. Resident 1 was prescribed Flexeril to be administered every evening, and Vistaril and Ativan for anxiety. She is to receive Ativan twice a day and PRN (as needed) and Visteril before bed and PRN. Each day a medication is administered, the residents' MORs are initialed by staff in a box indicating each day of the month. However, if the resident runs out of a drug, the staff member will put a circle in the box representing that day and makes a note on the back of the MOR. No circles or notes appear on Resident 1's MOR indicating that either drug was not available. Resident 1 is a patient of Nurse McCormick. Resident 1 becomes anxious or agitated if she does not receive her medication for her anxiety disorder. Nurse McCormick considered Resident 1's anxiety disorder well controlled by the medications. Resident 1's MOR reflects that she received Visteral from June 1 through 30 at night as ordered and received it PRN several times prior to June 23, 2011, but did not receive it PRN the rest of the month of June or July 1 through 14. She also received Ativan twice a day routinely in June and July and five times PRN during the period June 23 through 30, 2011, and four times during the period July 1 through 14. According to Nurse McCormick, either medication was appropriate for controlling Resident 1's anxiety disorder. Resident 1's MOR reflects that she received Flexeril on June 30, 2011. Nurse McCormick was not made aware at any time that Resident 1 was not receiving any of her medications. As the treating and prescribing nurse, missed or unavailable medications would have come to Nurse McCormick's attention. Resident 1 was not anxious, nervous or agitated when interviewed by Ms. Endress on July 12, 2011. There is no competent evidence that Resident 1 displayed any signs of anxiety, nervousness or agitation during the survey or during the times that the Amended Administrative Complaint alleges that she did not receive her medication. Nurse McCormick found the staff of Kipling Manor to be careful with all residents. She has been to the facility at various times of the day from early in the morning to late into the evening. Nurse McCormick is of the opinion that the staff takes care of all its residents and provides them with dignity. Despite Kipling Manor's resident population of seriously mentally ill residents, Nurse McCormick is of the opinion that the facility manages its residents with dignity and care. Count V--Background Check The Amended Administrative Complaint alleges that one staff member of Kipling Manor, the cook, had not been background screened. Based upon record review and staff interview, Ms. Endress determined that the facility did not complete a level 2 background check for 1 out of 8 sampled staff members. A record review revealed that this employee had been hired in April 2011. On April 26, 2011, the employee in question signed an Affidavit of Compliance with Background Screening Requirements, using AHCA form #3100-0008. By signing this form, the employee attested to never having been arrested for, pled nolo contendere to, or convicted of certain disqualifying offenses. Mr. Williams did not complete a background check on the cook because he did not think the cook was covered under the law. That is, he did not think the law applied to the cook because of the lack of personal contact with the residents. The cook is present during meal times serving plates of food to the dining workers who then directly serve the residents. The living areas are accessible to the cook. This employee no longer works at Kipling Manor. The record is not clear as to when he stopped working there. Ms. Endress determined that this constituted a Class II deficiency as she believed that it could potentially lead to harm to residents of the facility. According to Ms. McIntyre, AHCA always imposes a Level II deficiency for failure to have a level 2 background screening for employees. Both Ms. Endress and Ms. McIntyre testified at hearing regarding what constitutes Class II and Class III deficiencies. In several instances, Ms. Endress classified a violation or deficiency that could potentially result in harm to a resident as a Class II. Ms. McIntyre testified that "a potential harm to a resident could be a class II deficiency." She described a Class III as one that "indirectly threatens the physical, emotional health or safety of a resident. . . . indirectly or potentially." The Agency provided a mandatory correction date of August 1, 2011, for all five counts in the Administrative Complaint.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED: That the Agency for Health Care Administration enter a final order imposing a fine of $2,000, imposing a survey fee of $500, and dismissing the remaining allegations of the Amended Administrative Complaint against Respondent, Kipling Manor. DONE AND ENTERED this 1st day of May, 2012, in Tallahassee, Leon County, Florida. S BARBARA J. STAROS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of May, 2012.
The Issue The issue is whether Norwood Pines' annual licensure to operate an adult congregate living facility should be renewed. The Department denied renewal because of repeated failures to correct deficiencies at the facility, and due to the necessity to impose a moratorium on admissions on March 31, 1989, due to conditions at the home which threatened the health, safety, and welfare of residents.
Findings Of Fact Norwood Pines had been licensed as an Adult Congregate Living Facility (ACLF) under the "Adulte Congregate Living Facilities Act", Part II, Chapter 400, Florida Statutes. It had a licensed capacity of four beds. A survey of Norwood Pines was conducted by Lorraine Grissom, a registered nurse who serves as a senior community health nursing consultant for the Department. She regularly conducts ACLF licensure surveys. An ACLF is a home which provides housing, food service, and personal services for adults, which may include limited nursing services when the home is specifically licensed to do so. Section 400.402(2), Florida Statutes. An ACLF license is good for only one year. Section 400.417(1), Florida Statutes. At the time of the survey on March 31, 1989, four elderly women resided at the Norwood Pines ACLF: J.M., R.R., B.A.; and a fourth resident whose condition is not at issue in this proceeding. The home had been established by David Winfrey, and his wife, Barbara Winfrey, who is a registered nurse. Barbara Winfrey had been involved in the operation of the facility but had turned over responsibility for the ACLF to Mr. Winfrey. At the time of the survey on March 31, 1989, she was but of town, out of touch, and unavailable to consult with the aide at the home about problems with any of the residents. On her first visit Ms. Grissom observed one of the aides at the home was under the influence of come substance (whether alcohol or drugs could not be readily determined). The aide's gait was unsteady (she stumbled several times), her speech was slurred, and the content of her conversation was disorganized. The aides had never been given written job descriptions outlining their duties and responsibilities in providing personal care to the residents. Two residents at the ACLF were inappropriate for ACLF care. J.M. was incontinent, confused, and needed care beyond that which Norwood Pines was able to provide. Rule 10A- 5.0181(3)(a)1.e., Florida Administrative Code. B.A. was confused and disoriented; would wander outside in the rain, needed to be watched constantly; and needed to have drugs administered, because she was too disoriented to medicate herself. Rule 10A- 5.018(2)(a)4.c., Florida Administrative Code. B.A. was so disoriented that in case of fire she could not preserve herself or follow directions. Rule 10A-5.0181(2)(a)4.f., Florida Administrative Code. Food service at the home was inappropriate in that menus had not been dated and planned one week in advance, and menus were not followed in the preparation and service of food. Mr. Winfrey did not contest this survey finding, although he did maintain that residents got enough to eat. The administration of medications to residents was a severe problem at the home. There were problems with the supervision of administration of medications, the maintenance of proper medication records, and proper storage and labeling of medications. If a resident is fully capable of taking her own medication, she may purchase and maintain in her own room over- the-counter drugs such as aspirin or rolaids without a prescription, and without the necessity of a label showing the name of the resident, the name of the prescribing M.D. and instructions for the use of the medication. If the facility undertakes the responsibility for supervision of self- administered medications, staff must read the medication label to the resident when it is taken, check self-administered dosages against the label of the container, and assure that resident obtains and takes the dosage prescribed. Rules 10A-5.013(2)(jj) and 10A-5.024(1)(c), Florida Administrative Code. Medicines may be centrally stored but medicines so stored must be kept locked. Rule 10A-5.0182(3)(a)4.a., Florida Administrative Code. Resident R.R. was seen removing Excedrin from an unsecured cabinet in violation of the rule. The centrally stored medicines were not labeled with the name of the resident, the dose, the M.D. who prescribed it, and the directions for use, in violation of Rule 10A-5.0182(3)(a)5., Florida Administrative Code. A medication sheet was not kept for the medication administered to residents, contrary to Rule 10-5.024(1)(c), Florida Administrative Code. For example, resident R.R. had a prescription for 30 Tylenol #3 tablets filled on March 25, 1984. Although 5 tablets were left in the bottle on March 31, 1989, there is no indication on her medication sheet that she had been provided those tablets. This violates Rule 10A-5.0182(3)(b)2.h. and (c)1., Florida Administrative Code. In addition, there was no indication that Peri- Colace, which had been ordered by a physician for resident J.M., had been given. Staff advised Ms. Grissom that J.M. had not been given the medicine during the month of March because J.M. could not swallow it. This information was not given to J.M.'s physician. As a result, J.M. became impacted with feces. Staff was then instructed to administer Ex-lax to J.M. without a physician's order, and not to document its use on the medication sheet for J.M. Staff also gave J.M. a Fleet enema, without a physician's order. This was not proper treatment for the impaction. As a result of the impaction, JAM. had refused to eat for 2-3 days, was lethargic and was aspirating mucus. She also had difficulty breathing. The aide did not notify J.M.'s physician of this, even though her condition was a significant deviation from J.M.'s normal state of health, in violation of Rule 10A-5.0182 (1)(d), Florida Administrative Code. Resident B.A. needed to have her medication actually administered to her, rather than having supervision in taking her own medication. Staff at an ACLF may administer medication to a resident if there is a licensed RN or LPN on staff. There was no nurse at Norwood Pines to administer medication; it was done by an untrained, unlicensed aide, in violation of Rule 10A-5.0182(3)(b) and (c), Florida Administrative Code. This is especially significant because the medications involved were psychotropic drugs such as Mellaril, which the doctor ordered to be administered on an "as needed" basis for depression. This medication was given daily, because the aide did not know how to recognize behaviors which show that it was needed, something which a LPN or RN could be trained to recognize. Daily administration of Mellaril is dangerous, and contrary to the physician's instructions. The side effects of Mellaril can be severe shaking and involuntary movements, which is a particularly high risk for elderly persons, and can be irreversible. Other drugs which did appear on the medication sheets for patients on March 31, 1989, such as Lanoxin, and Haldol were not in the ACLF and therefore could not be administered as required. These violations found on March 31, 1989, had been brought to the attention of the Administrator before. Unlabeled medications, use of unlicensed staff to give medication and the lack of health assessments had been cited as deficiencies on the October 22, 1988, survey. Ms. Grissom returned on May 31, 1989, for a follow- up survey to see whether the deficiencies identified on March 31, 1989, had been corrected. All of the deficiencies remained uncorrected, including those related to proper storage, labeling, recording and supervision of the administration of medication; to the criteria for retaining residents at the home; to staff awareness of health and well-being of residents; and to provision of appropriate staff and food service. The Administrator, Mr. Winfrey, did not contest that these deficiencies had not been corrected on May 31, 1989. On May 31, 1989, Mellaril was still being given to R.R. by an untrained, unlicensed aide when the physician required that it be given on an "as needed" basis. Five hundred milligrams of calcium was being given to R.R., although the medication was unlabeled, and there was no doctor's order to provide it. A doctor had ordered that potassium be given to B.A. with plenty of water and with food, but she was given only a small amount of orange juice in a four ounce cup with the potassium. Ms. Grissom explained that it is dangerous to give potassium in a manner other than as ordered to patients with heart problems such as B.A. The medication records did not show that two other medications given for heart disease, Lanoxin and Lasix were being given daily as prescribed. B.A. was still a resident at the home on May 31, 1989, though she was still so disoriented that it was inappropriate for her to be in an ACLF. B.A. was only transferred to a facility appropriate for her care after Ms. Grissom made another visit on October 30, 1989. On May 31, 1989, staff was still unable to perform duties and ensure proper care of residents because the untrained aide was still responsible for administering psychotropic medications to residents. A final appraisal of the home was done on October 30, 1989, by Ms. Grissom. At that time, untrained, unlicensed staff was still administering medications and admitted doing so. As noted above, B.A. who was an inappropriate client, still resided at the facility. Medication records were still as inaccurate as they had been on March 31 and May 31, 1989. The daily records were not being kept as medications were given. When Ms. Grissom asked the aide for the resident's files, the aide brought menus. In short, the aide was unprepared to do those things expected of her. Health assessments for the residents were not available, although the facility had been cited for this deficiency in the October 28, 1988, survey. By the October visit, Haldol had been ordered for B.A. by her physician, to be administered "as needed," but was given as a regular dose. Mellaril, another dangerous drug, had been ordered to be given up to three times a day as needed for depression to R.R., but it was given three times a day as a regular dose, even though R.R. showed no signs of depression. None of the findings about the October 30, 1989, were controverted by Mr. Winfrey. As a result of the March 31, 1989, survey a moratorium on admissions was imposed at the Norwood Pines ACLF due to conditions which threatened the residents' health, safety, and welfare. Norwood Pines did not appeal the moratorium.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered denying the request of Norwood Pines for a renewal license to operate an Adult Congregate Living Facility. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 27th day of March, 1990. WILLIAM R. DORSEY, JR. 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 27th day of March, 1990. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 89-4346 The substance of the proposals submitted by the Department have been accepted. No proposed findings of fact were submitted by Norwood Pines. COPIES FURNISHED: Leonard T. Helfand, Esquire Department of Health and Rehabilitative Services 401 Northwest Second Avenue North Tower, Room 526 Miami, Florida 33128 David G. Winfrey Norwood Pines 19021 Northwest 10th Street Miami, Florida 33169 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 John Miller, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
The Issue Whether disciplinary action should be taken against Respondent's license to practice medicine based on: The allegations of the Administrative Complaint in DOAH Case No. 97-3363, pertaining to patient R.W., of violations of Sections 458.331(1)(q), Florida Statutes, [failure to appropriately prescribe in the best interest of the patient]; 458.331(1)(t), Florida Statutes, [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]; and Section 458.331(1)(m), Florida Statutes, [failure to keep medical records justifying the course of treatment of the patient during his care of the patient]; and The allegations of the Administrative Complaint in DOAH Case No. 97-3442, pertaining to patient N.W., of violating Section 458.331(1)(t), Florida Statutes, [failure to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances].
Findings Of Fact Respondent is a licensed medical physician in the State of Florida and has been licensed in Florida at all times material under license number ME0041782. Respondent is Board-certified in internal medicine, and his area of specialty is pulmonary medicine. AHCA Case No. 95-5043; DOAH Case No. 97-3442; Patient R.W. On or about November 5, 1990, Patient Mr. R.W. suffered a work-related accident resulting in a very significant injury to his back, including a complete disc herniation. On November 10, 1990, orthopedic surgeon Georges El Bahri, M.D., performed major spinal surgery, including a complete laminectomy of L4, L5, disc excision of L5, S1, and exploratory surgery in the region of S1 on R.W. at Memorial Medical Center in Jacksonville, Florida. This surgery was of an emergency nature to prevent paraplegia. Prior to this surgery, R.W. was referred by Dr. El Bahri to Respondent on a pulmonary consult for surgical clearance because R.W. was suffering from chronic pulmonary disease, (CPD). R.W. experienced genitourinary dysfunction (a dysfunction of the genitalia or urinary organs) as a result of his accident, and he saw a urologist, Mohammed N. Mona, M.D., for treatment. On November 22, 1990, a second surgery was required for removal of a previously unidentified disc fragment. Dr. El Bahri recommended a spinal fusion. Evaluation by a second orthopedic surgeon indicated that R.W. had suffered a 30 percent disability of the body as a whole related to his orthopedic injuries. The second orthopedic surgeon also suggested a bone fusion. A spinal fusion operation would have exposed R.W. to a risk of loss of lower body function, and he declined the operation. Dr. El Bahri referred R.W. to Respondent to provide continuing care for R.W.'s pulmonary problem. Without surgery, R.W.'s back pain would continue to be severe and intractable. Dr. El Bahri had tried multiple alternative modalities of pain management with R.W. during the period of time that he participated in R.W.'s care, including use of a cane, weight reduction, corset, body brace, physical therapy, and a transcutaneous epidural nerve stimulator unit (TENS). Dr. El Bahri also had prescribed pain mediation for R.W. An implanted nerve stimulation device had been recommended, but R.W. declined it. Dr. El Bahri and Respondent consulted concerning efforts to control R.W.'s pain. Dr. El Bahri made Respondent aware of the various alternative pain modalities that he had tried. At some point, it was agreed between Dr. El Bahri and Respondent that where there is intractable pain requiring prescription drugs, one physician should assume primary care. Dr. El Bahri, as the orthopedic surgeon who could not get R.W. to agree to further surgery, deferred to Respondent who was treating R.W.'s chronic pulmonary problems. Dr. El Bahri and Respondent agreed that Respondent would prescribe analgesic and other medications for management of R.W.'s intractable pain. R.W.'s first office visit with Respondent was on May 3, 1991, and his last office visit was on June 16, 1993. Petitioner alleged violations by Respondent both as to level of care and the keeping of medical records because he did not perform and record a full physical for R.W. at or about the time of R.W.'s first office visit. However, Dr. Harvey, testifying on behalf of Petitioner, as well as Dr. Corral, testifying on behalf of Respondent, agreed that it would not be necessary for Respondent to repeat a complete history and physical on R.W. between the November 1990 hospital consultation and physical and the May 3, 1991, office visit. Dr. Harvey would have allowed a ten-month delay, and Dr. Corral felt no further complete physical was necessary for treatment of a chronic condition so long as there was evidence of frequent office visit evaluations. All the medical expert witnesses faulted Respondent's office records if they did not physically contain the hospital consultation sheets, and there is reason to believe that Respondent's office records did not include the consultation sheets until after R.W.'s death. Likewise, I do not find the other, later brief notes in Respondent's office records of partial examinations by Respondent or by his Physician's Assistant to constitute sufficient alternative documentation under the circumstances. See, infra. Therefore, to this degree, Respondent's records did not justify his course of treatment of R.W. R.W. presented to Respondent with multiple problems: intractable back pain secondary to his injuries, chronic obstructive pulmonary disease (CPD-COPD), a history of smoking a pack and a half of cigarettes every day for 25 years, impotency, back surgery, hyperlipidemia, and labile hypertension. "Hyperlipidemia" means high cholesterol and trigylcerides. "Labile hypertension" refers to erratic high blood pressure. At 205 pounds, R.W. also was overweight, but not "morbidly obese" for his height and age. While under Respondent's care, R.W. continued to suffer from intractable back pain secondary to his injury, anxiety, and situational depression. On April 10, 1992, while under Respondent's care, R.W. underwent a psychiatric evaluation at the University of Florida Health Sciences Center in Jacksonville, Florida. The psychiatrist, Ernest C. Miller, M.D., prepared a report dated June 9, 1992, in which he indicated that R.W. suffered adult situational disorder with chronic depression. He recommended "psychiatric contact." Respondent facilitated the workers' compensation insurance carrier's referral of R.W. to the psychiatrist for evaluation. Respondent's office records are deficient on this matter, but it appears most likely from the evidence as a whole that R.W. did not follow up on the psychiatrist's recommendation for psychiatric counseling because his workers' compensation employer-carrier declined to pay for any further psychiatric care. Although Dr. Harvey testified that Respondent should have tried to talk R.W. into psychiatric counseling, the evidence as a whole falls short of demonstrating that Respondent bore any professional responsibility to force R.W. into psychiatric care or counseling against R.W.'s will and at R.W.'s own expense. The psychiatrist recommended tricyclic anti- depressants. Respondent prescribed tricyclic anti-depressants as well as other drugs described infra. Respondent obtained consultations of specialists, including two orthopedic physicians and a neurosurgeon. Respondent also tried additional alternative modalities of pain management, including Marcaine (analgesic) trigger point injections, and topical anesthetics. Despite Petitioner's charge that Respondent's care of R.W. was substandard due to his failure to refer R.W. to a pain management specialist, I find that between Dr. El Bahri and Respondent, most acceptable pain management modalities were attempted with R.W, and Respondent's failure to refer R.W. to a pain management specialist did not fall below the professional standard of care. In making this finding of fact, I have given weighted consideration to Dr. Harvey's testimony that there was no other pain management besides drugs unless Respondent could talk R.W. into psychiatric counseling or surgery, or retrying a TENS unit, and to Dr. Corral's testimony that it was not necessary for Respondent to consult with a pain specialist because the patient had refused all invasive and some non- invasive pain management and that anything other than invasive pain management could be done for R.W. by the Respondent. During the period of time R.W. was under Respondent's care, Respondent prescribed to him analgesic medications for pain. He also prescribed anti-depressant, anti-anxiety, and muscle relaxant medications. It is with the quantity of these prescriptions, the inter-action of the drugs prescribed, and the failure to record these prescriptions in Respondent's office records for R.W. that the Petitioner finds fault. Between April 21, 1992, and July 6, 1993, Respondent wrote R.W. in excess of 30 prescriptions for pain management and depression. Dispensation of these prescriptions, including approved refills, exceeded 4,000 tablets. However, during this period of time, Respondent also recorded 11 office visits: 4/21/92, 5/15/92, 5/18/92, 5/20/92, 6/18/92, 8/21/92, 11/9/92, 2/1/93, 4/5/93, 5/4/93, and 6/16/93. Based on a "Pharmacy Profile," R.W. received the following medications prescribed by Respondent between April 21, 1992, and July 6, 1993. Drug Prescribed Dosage/Quantity Dates Filled Diazepam 10mg 50 06/16/93 Amitriptyline 50mg 30 07/24/92 50mg 30 08/11/92 50mg 30 09/23/92 50mg 30 10/20/92 50mg 30 11/20/92 50mg 30 12/16/92 100mg 30 02/01/93 100mg 30 03/03/93 100mg 30 04/02/93 100mg 30 05/03/93 150mg 30 05/07/93 100mg 30 06/02/93 100mg 30 06/25/93 Drug Prescribed Dosage/Quantity Dates Filled Lorcet Plus 100 06/18/92 100 07/15/92 100 08/11/92 90 09/11/92 90 10/07/92 90 11/09/92 90 12/07/92 90 12/31/92 90 01/29/93 100 03/01/93 100 04/02/93 100 05/03/93 100 05/07/93 100 06/07/93 100 07/06/93 Roxicet 5/325 40 04/05/93 Clorazepate 100 04/05/93 Xanax 1mg 100 04/22/92 100 05/26/92 100 07/09/92 100 08/11/92 100 10/07/92 100 11/09/92 100 12/07/92 100 12/31/92 100 01/29/93 100 03/01/93 100 04/02/93 100 05/03/93 100 06/07/93 100 07/06/93 Acetaminophen 500mg 100 09/11/92 100 10/20/92 100 11/20/92 100 12/05/92 100 02/10/93 Notriptyline 50mg 120 09/11/92 120 10/20/92 120 01/18/93 Carisoprodol 350mg 100 05/07/93 100 07/06/93 Xanax, Lorcet Plus, Amitriptyline, Clorazepate, Roxicet, Diazepam, and Carisoprodol are Central Nervous System (CNS) depressants and several, including Xanax and Diazepam (Valium), are benzodiazepines. When taken together, CNS depressants can produce additive CNS effects. Benzodiazepines are drugs which are in a class of structurally related compounds. They have sedative, anti- convulsant, and skeletal muscle relaxant properties and are used for the treatment of anxiety and other purposes. Using several benzodiazepines together can also be fatal, because the patient may develop a tolerance to the drug and ultimately consume toxic dosages. Xanax is a Schedule IV legend drug used to treat anxiety disorders. It produces additive CNS depressant effects when administered with other CNS depressants. Lorcet Plus is a Schedule III legend drug which contains Hydrocodone. It is used for treating moderate to moderately severe pain. If used with other CNS depressants, it can produce additive CNS depression. Amitriptyline is a legend drug and a trycyclic anti- depressant. It can enhance the effects of alcohol, barbiturates, and CNS depressants. It can aggravate heart conditions. Clorazepate is a Schedule IV benzodiazepine legend drug indicated for the treatment of anxiety disorders. It has a CNS effect. Clorazepate should not be administered to patients with indications of drug dependencies. Roxicet is a Schedule II legend drug which has a high potential for abuse and has a currently accepted, but severely restricted, medical use. It can produce dependency of the morphine type. Diazepam is a Schedule IV drug indicated for the treatment of anxiety disorder. It is a form of Valium and is a CNS depressant. Nortriptyline is a legend drug that is a tricyclic anti-depressant. Carisoprodol is a legend drug that is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. It is a CNS depressant. R.W. died unexpectedly at his home on July 9, 1993. Petitioner contends that because the prescribed medications were not listed in R.W.'s chart at the material times, the prescriptions and renewals were given by Respondent without any reference to a medical record which would allow Respondent or any physician to provide R.W. with sufficient warnings or information regarding the combined use of these drugs and/or to appropriately monitor or limit R.W.'s simultaneous intake of the CNS depressants, and that, whether one concludes that R.W. died due to multiple drug toxicity or as a result of a myocardial infarction is not critical, but that Respondent's care and treatment was so careless as to create an environment in which R.W. was an "accident waiting to happen." All the testifying medical experts agreed that Respondent should have given R.W. medication overdose and interaction warnings. Respondent claims to have orally warned R.W. and R.W.'s wife concerning R.W.'s prescriptions, but it is not disputed that prior to R.W.'s death, R.W.'s chart/medical records in Respondent's office did not contain adequate notations of oral medication overdose and interaction warnings. Dr. Corral testified that not all such warnings must be recorded. It is also undisputed that prior to R.W.'s death, his chart/records in Respondent's office did not contain adequate notes on the drugs prescribed by Respondent. In his office practice, Respondent had established a system whereby requests for refills of medications previously prescribed to patients would be documented on a separate IO9 drug tally sheet or "day sheet" by Respondent's staff. Sometime during each work day, Respondent would review the list of requested refills, and approve or deny each by making a written notation on the "day sheet." Respondent's staff would then telephonically authorize the pharmacy to refill only those prescriptions that Respondent had authorized in writing. By making a written notation approving requested refills, Respondent was creating a record of drugs he prescribed. Under Respondent's system, his staff members were then supposed to transpose the refill information from the "day sheet" onto each patient's individual medical record chart. The aforementioned system for approval of requested refills and documentation thereof is an acceptable means of documenting refill information on medications for individual patient charts, but it was not followed in this instance. Vickie Browning, as receptionist and "front office" staff member, was primarily responsible for the transfer of the medication information from the day sheets to individual patient charts. Periodically, when she got backed up with telephone calls or otherwise behind in her work, Ms. Browning simply threw away piled-up day sheets without transferring the prescription information to individual patient charts. In making this finding of fact, I have noted the clear testimony of another staff member, Angie McKenzie, who saw Ms. Browning throw away a pile of prescription day sheets, but who admittedly did not advise Respondent of what was going on. I also have considered Linda Eady Turner's testimony that Ms. Turner saw a pile of day sheets in the trash can on a single occasion. I also have carefully scrutinized Ms. Browning's testimony, which by candor and demeanor, internal inconsistencies, and motivation to fabricate, I find to be unreliable and incredible. Despite R.W.'s 11 office visits during the material period of time, during each of which Respondent presumably reviewed R.W.'s chart, Respondent did not become aware that prescription refill information was not being recorded in R.W.'s chart. Likewise, Respondent did not become aware that prescription refill information was not being recorded in any patient charts until he reviewed R.W.'s medical chart after R.W.'s death. As the medical professional ultimately responsible for accuracy of medical records and treatment of his patients, Respondent should have noted the gaps on R.W.'s and other patients' charts before he did. For the same reasons, he should have known, prior to R.W.'s death, that his system was not being followed. After R.W.'s death, the Duval County Medical Examiner confiscated drugs from R.W.'s home and created a Medication Log containing the following drugs: Xanax 1 mg, 1-1/2 pills remaining; Amitriptyline 150 mg, 1 remaining; Amitriptyline 100 mg, 8 remaining; Ketoproten 75 mg, 61 remaining, Zantac 150 mg, 1 remaining; Amoxicillin 500 mg, 1 remaining; Helotestin 10 mg, 9 remaining; Lorcet Plus tablets, 88 remaining; Carisoprodol 350 mg, 54 remaining; Xanax 1 mg, 88-1/2 remaining; Carisoprodol 350 mg, 97 remaining; and Hydrocodone, 27 remaining. All of these drugs were prescribed by Respondent. Laboratory tests performed on R.W. revealed the presence of Amitriptyline, Hydrocodone, Nordiazepam (which is from Diazepam), Carisoprodol, and Xanax. Respondent was quickly embroiled in legal actions arising out of R.W.'s death. Upon discovering that prescription refill information relating to R.W. had not been recorded by his staff on R.W.'s chart, Respondent instructed members of his staff to obtain prescription information from the pharmacy, and recreate a medication list for R.W.'s chart. He further advised his staff to record any recollections they had which related to interactions of any staff members and R.W. or R.W.'s wife. Once his staff had completed the prescription information recreation, Respondent placed a note on the recreated records, identifying them as recreations and not contemporaneous notes. He also advised his attorney and the attorney representing the estate of R.W. of the recreated records. This would logically show no intent to, or conspiracy by, Respondent to fabricate or falsify patient records, but merely an intent and effort to recreate prescription information for his defense at trial. In making this finding of fact, I have again discounted Ms. Browning's testimony for the reasons previously cited. All testifying medical experts agreed that it is professionally acceptable for a medical physician to add notes as an addendum, provided the physician indicates the date of additional notes and clearly shows that they are not contemporaneous. At the request of one of R.W.'s relatives employed in the Sheriff's Office, the Assistant Medical Examiner for Duval County, Dr. Bonafacio Floro, performed an autopsy on R.W.'s corpse. He opined that the immediate cause of R.W.'s death was "multiple drug toxicity," although he noted "arteriosclerotic disease" as a secondary, or contributing, cause of death. He also speculated that one or more prescription drugs could have caused a myocardial infarction. In formulating his opinion on the proximate cause of R.W.'s death, Dr. Floro relied almost exclusively on laboratory tests performed by the Duval County Medical Examiner's Office and by an outside laboratory revealing the presence of several drugs in R.W.'s blood. The results of the drug tests performed by the Duval County Medical Examiner's Office and the outside laboratory are inconsistent, but this is largely a difference without a distinction. By either test, R.W.'s blood level of Hydrocodone would be "lethal" as established by a generally accepted medical text, and his blood level of Xanax would be "toxic" as established by the same generally accepted medical text. This medical text, however, is basically only a catalogue of drug toxicity levels in persons already dead. According to Dr. Venard Adams, however, all of the drugs in R.W.'s blood at the time of his death were at therapeutic levels, except for Hydrocodone, which was at the low end of the generally accepted lethal range, and this level might not be lethal for one who had developed a tolerance for several drugs. Dr. Adams's opinion on this score was shared by Dr. Thomas F. Hegert. Each of these physicians are also Florida Medical Examiners. Dr. Floro's conclusion that multiple drug toxicity was the proximate cause of R.W.'s death also was not shared by the other medical experts, and Dr. Floro conceded that he had no opinion on where the line is crossed between achieving therapeutic levels and toxic or lethal levels in living patients with increased medicinal tolerance. Except for Dr. Floro, all of the other medical experts testified that the Respondent's prescriptions for R.W. continued to be mostly the same types and amount of each drug from R.W.'s first visit to his last; that Respondent's prescriptions did not exceed reasonable amounts of each individual medication; that in some cases the amounts Respondent prescribed were less than the maximum amounts permissible for individual medications; and that the prescriptions, if taken as prescribed, should not have exceeded reasonable amounts for their purpose. Dr. Corral considered Respondent's use of all the drugs together to be common practice. Dr. Hegert considered the combination of drugs selected by Respondent to be appropriate within current chronic pain management therapy and effective, in that because of the combination and amounts Respondent used, Respondent would not have had to prescribe even stronger pain medications which have a greater potential for addiction than those Respondent actually used. Dr. Hegert also found no indication that the drug levels in R.W.'s blood at death, as indicated by the laboratory reports, were any different than the probable levels R.W. had experienced over a considerable period of time. Although Dr. Floro reviewed some cut sections of the deceased's heart, Dr. Floro did not clearly acknowledge evidence of an acute myocardial infarction. Cut sections of R.W.'s heart were prepared with a special stain by Dr. Hegert and microscopically viewed. These sections revealed myocardial injury, "clear evidence" of an acute myocardial infarction. Dr. Hegert concluded that R.W. died of acute myocardial infarction secondary to severe coronary artery disease. There are a few pills from R.W.'s last prescriptions which are unaccounted for, but this is insufficient under the facts of this case to assume that R.W. consumed more pills than the labels prescribed or that excessive use of a single prescription drug or several prescription drugs triggered his myocardial infarction. In light of the testimony of a borderline nature for R.W. of the Hydrocodone level and the probable therapeutic level of the other drugs, there is no clear and convincing evidence that R.W. exceeded the labeled dosage. There is certainly no clear evidence that if R.W. exceeded the labeled dosage, he did so because of Respondent's failure to warn him. Finally, there is no clear and convincing evidence that Respondent's prescription practice rendered R.W. chemically dependent on prescription drugs. AHCA Case No. 95-01594; DOAH Case No. 97-3363; Patient N.W. Mrs. N.W. had been a patient of Respondent since April 17, 1992. Approximately a year before April 6, 1994, N.W. had required hospitalization due to severe gastroenteritis. At that time, she was hospitalized for re-hydration and attendant care. Thereafter, until April 6, 1994, N.W. enjoyed reasonably good health, except that she suffered from systemic lupus and erythema. On Wednesday, April 6, 1994, N.W. presented to Respondent's office with complaints of having eaten bad ham at a picnic, nausea, vomiting, and diarrhea for several days. These were similar symptoms to those at her hospitalization the year before. Long-term nausea, vomiting, and diarrhea can cause severe dehydration. Respondent recommended that N.W. be hospitalized for re-hydration. N.W. and her husband refused, accepting instead a prescription for antibiotics. On Friday, April 8, 1994, N.W. was not improved and either she or her husband contacted Respondent's office. Respondent's office was advised that N.W. had continued to suffer from nausea, vomiting, and diarrhea since her Wednesday office visit. N.W. then accepted Respondent's recommendation, and directions were given for her to be directly admitted to Memorial Medical Center (hospital) in Jacksonville, Florida, without first being seen at Respondent's office. N.W. was admitted to the hospital at approximately 4:30 p.m. Patients suffering from dehydration can develop hypovolemia (low blood volume) and can appear very ill and develop low blood pressure (hypotension); high or low heart rate (tachycardia or bradycardia); and become cold and clammy. These symptoms are also consistent with a myocardial infarction, although high heart rate is more common than bradycardia with a myocardial infarction. Appropriate treatment of hypovolemia is re-hydration through the administration of intravenous (IV) fluids. N.W. ultimately died four days later on April 12, 1994, from congestive heart failure initiated by a myocardial infarction which had most probably occurred sometime around noon on April 8, 1994, prior to her admission to the hospital. All witnesses concur that the only period of time that is material to the charges against Respondent is approximately 4:00 p.m. April 8, 1994 to 8:00 a.m. April 9, 1994. The thrust of the Administrative Complaint is that the information of an abnormal EKG and abnormal cardiac enzymes were repeatedly relayed to Respondent by telephone and that he failed to timely take aggressive action. Sometime subsequent to April 9, 1994, the nursing progress notes covering the period of time from approximately 8:00 p.m. April 8, 1994, until approximately 7:00 a.m. April 9, 1994, were found to be missing. Subsequently, the hospital's Risk Management staff directed that the nursing notes be recreated. The recreated notes were reviewed by the Risk Management staff and the hospital attorney. They were dissatisfied with them as being too subjective. At their instruction, a second set of nursing notes was recreated. However, Risk Management and the hospital attorney ultimately included the first set of recreated notes in N.W.'s hospital chart, believing that the first set of recreated notes would be more accurate because they were closer in time to the events charted. The copy of a 7:32 p.m. April 8, 1994, electrocardiogram (EKG) report currently in the hospital chart, which indicates an acute myocardial infarction, was not the copy of the EKG interpretation that was originally placed in N.W.'s hospital chart during the period of time that N.W. was hospitalized on April 8, 1994. The EKG copy in the hospital chart is a copy that has been interpreted by a cardiologist, Benjamin C. Olive, M.D. The undersigned has had the benefit of considering both sets of recreated notes, the witnesses' testimony, and all other exhibits admitted in evidence. In making the following Findings of Fact, the undersigned has compared, considered credibility, and weighed all elements of the record. After initial evaluation by hospital nursing staff, N.W. was evaluated at approximately 7:30 p.m., by Earl Manion, Respondent's Physician's Assistant. Mr. Manion noted, among other things, that because N.W.'s abdominal pain was very high up into the sternum, cardiac involvement should be investigated. Mr. Manion gave appropriate orders for initial laboratory and radiological evaluation of N.W. A CPK test is part of a standard chemistry panel done for all admittees, but the initial tests ordered by Mr. Manion included the performance of an EKG and blood chemical studies including cardiac enzyme testing (CPK-MB). At Memorial Medical Center, as in many facilities, EKGs are initially interpreted by a computer program, which provides a printed verbal interpretation of the EKG. Hospital nurses are not expected to interpret the line configurations on EKGs. Standard procedure is for them to notify the admitting physician of the computer's printed verbal interpretation. Mr. Manion did not remain on the cardiopulmonary floor to which N.W. was initially assigned (Three South Tower) to read the results of the tests he had ordered. He anticipated that Respondent would shortly be making rounds and would see the test results for himself. He did not relay his cardiac concerns to Respondent or tell Respondent that he had ordered a CPK-MB instead of a CPK test. In fact, Respondent did not make rounds that evening, and there was no requirement that he should do so. Lay persons normally refer to a myocardial infarction as a "heart attack." Persons can suffer from a myocardial infarction and, dependent upon its severity, they may not even be aware it has occurred. A myocardial infarction may be classified as "acute," meaning "recent" or "on-going," or it may be classified as "chronic," meaning "old" or "in the past." If it is an old infarction, no immediate physician response is necessary. The first EKG performed on N.W. printed out the verbal interpretation of "consider inferior infarct, age undetermined." This result is not an acute myocardial infarction alert. This result was reported telephonically to Respondent by Donna Hughes, R.N. Nurse Hughes was the first nurse significantly involved in N.W.'s care, and was the responsible nurse between admission and midnight on April 8, 1994. The CPK-MB test results came in subsequent to Ms. Hughes' first telephone call to Respondent, so she made a second telephone call to Respondent about 10:30 p.m. on April 8, 1994. She subsequently recreated notes to the effect that she related to Respondent that N.W. showed "elevated cardiac enzymes," but in her testimony, Ms. Hughes confirmed that she recalled telling Respondent only that the "CPK" was elevated. Despite reports by N.W.'s husband that his wife's face "was turning colors," neither nurse Hughes nor Physician's Assistant Manion observed such a phenomenon. In fact, to them, N.W. denied any chest pain or chest tightness. Nurse Hughes did not believe that N.W. was having a myocardial infarction during her shift. Chemical tests can be performed on a patient's blood for various enzymes that are released into the bloodstream as a result of stress on muscle systems. Various enzymes and "bands" of enzymes reflect stress or damage to different muscle systems. A CPK is an enzyme test that may indicate damage to muscles in the body generally, or more specifically, damage to skeletal muscles. It may also reflect systems' reactions to injected anti-vomiting medications, which N.W. had received. A CPK-MB (or CK-MB) band is a more specific enzyme test that is indicative of stress or damage to the heart muscle. The CPK-MB (or CK-MB) band is appropriately referred to as a "cardiac enzyme test." The CPK is not appropriately referred to as a "cardiac enzyme test." There is no clear and convincing evidence that Nurse Hughes advised Respondent that the CPK-MB or CK-MB was elevated. It is more likely that she only correctly identified that the test was a "cardiac enzyme test" in her recreated notes. Because Respondent was aware of N.W.'s past history of gastroenteritis and that N.W. had been suffering from vomiting, including retching, and had received intra-muscular injections of anti-nausea medication, and because retching and intra-muscular injections can result in an elevated CPK, it would be reasonable for him to discount the results of a CPK, which he did during the second phone call from Nurse Hughes. He ordered an increase in the potassium IV. Jennifer Stephenson, R.N., was a graduate nurse (G.N.) performing nursing care for N.W. on Three South Tower after midnight on April 8, 1994. She involved the charge nurse and the nurse coordinator due to her G.N. status and due to her concern for N.W.'s condition. She placed a telephone call to Respondent's "service" but did not speak to him. When Respondent returned the telephone call, his call was received by Tess Bunal, R.N. He denied that any clear information about the CPK-MB or about a new EKG was given to him in this phone call. During this phone call, Respondent authorized the transfer of N.W. to the Telemetry Unit (Three Central) for closer monitoring. The Telemetry Unit is a monitored unit with heart pattern displayed at each bedside and at a monitor bank. It provides one staff nurse for every three to four patients. It is only one step down from an intensive care floor. Upon N.W.'s arrival at the Telemetry Unit, Kevin Murphy, R.N. became the nurse involved in her care. Mr. Murphy spoke with Respondent at or about 1:40 a.m. on April 9, 1994, regarding N.W.'s EKG, low blood pressure, and increased heart rate. At that time, Nurse Murphy relied on another nurse's oral report that Respondent had already been informed of the elevated heart enzymes and also had been informed of the results of an abnormal EKG. Nurse Murphy recommended that N.W. be transferred to an intensive care unit, also known as a "cardiac care unit" (CCU). However, Mr. Murphy testified that he did not advise Respondent of the result of the EKG or any specific enzyme results, because he believed Respondent already had that information. The Respondent rejected Nurse Murphy's recommendation to transfer N.W. to CCU. Instead, he gave orders to increase the IV. Nurse Murphy was uncomfortable with Respondent's response to his recommendation. He closely monitored N.W. N.W.'s vital signs did not change markedly, but she continued to complain of nausea and even some chest tightness. Nurse Murphy ordered another EKG, which showed an "acute myocardial infarction." He again spoke with Respondent by telephone at approximately 3:40 a.m. on April 9, 1994, and again requested that N.W. be transferred to the intensive care unit. He did not inform Respondent of an EKG showing "acute myocardial infarction" or that the MB band was elevated. His testimony does not clarify whether he did or did not relay to Respondent any complaint of chest tightness. However, at Nurse Murphy's insistence, Respondent ordered N.W. transferred to CCU. At no time on any of the three units (cardiopulmonary, telemetry, or cardiac care) did any nurse become sufficiently concerned about N.W.'s condition or about Respondent's responses so as to call on the hospital's "fail safe" procedures which included the opportunity to involve an on-call "intensivist." At approximately 7:00 a.m. on April 9, 1994, a new nurse, Nurse Waples, began her shift on CCU. She contacted Respondent by telephone at 7:20 a.m. and advised Respondent clearly that N.W. was complaining of chest tightness, and of the results of the latest EKG. She also clearly stated that N.W. had an elevated CK-MB. Respondent immediately gave appropriate orders for evaluation and treatment of a possible cardiac problem, including EKG, cardiac medication, oxygen, arterial blood gases, pulse oxymeter, and a cardiac consultation, and he proceeded directly to the hospital. The Respondent saw N.W. in the hospital for the first time at 7:55 a.m. on April 9, 1994. At that time, he and a cardiologist correctly diagnosed her as having had an acute myocardial infarction and going into cardiogenic shock. Respondent timely requested the participation of a cardiologist and provided appropriate orders for N.W.'s cardiac condition. He also appropriately monitored her status. Nonetheless, N.W. ultimately went into congestive heart failure. After several unsuccessful treatment attempts, she died on April 12, 1994, at 5:33 p.m. Petitioner's medical physician expert, Dr. Patel, testified that Respondent, in response to the several nurses' telephone calls concerning "elevated cardiac enzymes" and an abnormal EKG, should have either been in immediate personal attendance at N.W.'s bedside, or should have obtained a proper consultation with a cardiologist, and/or should have called on the intensivist provided by the hospital, and that Respondent's failure to take at least one of these courses of action constituted his failure to practice medicine with that level of care, skill, and treatment recognized by reasonably prudent physicians as being acceptable under similar conditions and circumstances. Respondent's experts agreed that if Respondent had received clear notification of an "acute" condition by EKG, of an elevated CPK-MB or CK-MB, or of clear symptomatology such as chest pain, these were "red flags" telling Respondent that he should aggressively address a cardiac problem. However, all experts, even Dr. Patel, concurred that if the EKG had showed only "consider inferior infarct, age undetermined," that, alone, would not be sufficient to trigger an immediate response from Respondent. Based on all he reviewed, which was not all of the evidence in this case, Dr. Patel acknowledged that if the information relayed by Nurse Waples had been given Respondent earlier he could have met the standard of care by merely requesting that the nurse call a cardiologist for a consultation or call the hospital's intensivist to see N.W. Under these circumstances, Respondent would not even have had to come into the hospital, and therefore his failure to respond could not be attributed to "laziness." Because Respondent acted knowledgeably and appropriately when clearly informed of N.W.'s condition by Nurse Waples, Dr. Patel would not attribute Respondent's lack of response to lack of knowledge or ability. Dr. Patel ultimately opined that because the first set of recreated notes showed repeated notifications to Respondent that N.W.'s blood pressure was falling while her heart rate was rising; this, with all the other information, including notification of chest tightness, should have resulted in a more aggressive response from Respondent, but he conceded that these symptoms occasionally are consistent with hypovolemia, and the undersigned notes that in testimony, only Nurse Murphy clearly testified that he notified Respondent of the disparity in blood pressure and heart rate, and did not specifically state that he mentioned chest tightness. No witness clearly suggested that Respondent had an affirmative duty to inquire whether a CPK or CPK-MB had been administered to N.W., or to inquire if a second EKG had been performed after the first one, or to personally order a subsequent EKG based on the several phone calls as related by the testifying nurses. No one testified that repeated phone calls from nursing staff by itself should have alerted Respondent to a myocardial infarction. Respondent's experts concurred that absent clear notification of an elevated CPK-MB, the information that N.W.'s EKG showed an old myocardial infarction did not require any response beyond the responses Respondent made.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Medicine enter a Final Order that Finds Respondent not guilty of violating Section 458.331(1)(t) in DOAH Case No. 97-3363 with regard to Patient N.W. Finds Respondent not guilty of violating Sections 458.331(1)(q) and (t), in DOAH Case No. 97-3442 with regard to Patient R.W. Finds Respondent guilty of violating Section 458.331(1)(m) Florida Statutes, in DOAH Case No. 97-3442 with regard to Patient R.W., and imposes a penalty of two months suspension of license followed by probation of Respondent's license for six months upon such terms and conditions as the Board may impose to correct his record-keeping, and imposes a $1,000.00 fine. See Rule 21M-20.001(2)(m), Florida Administrative Code. DONE AND ENTERED this 18th day of August, 1998, in Tallahassee, Leon County, Florida. ELLA JANE P. 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 Filed with the Clerk of the Division of Administrative Hearings this 18th day of August, 1998. COPIES FURNISHED: Bruce Lamb, Esquire Shear, Newman, Hahn & Rosenkranz, P.A. Post Office Box 2378 Tampa, Florida 33601 Albert Peacock, Senior Attorney Agency for Health Care Administration 2727 Mahan Drive Post Office Box 14229 Tallahassee, Florida 32317 Dr. Marm Harris, Executive Director Department of Health Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Angela T. Hall, Agency Clerk Department of Health 1317 Winewood Boulevard Building 6 Tallahassee, Florida 32399-0700
Findings Of Fact The Respondent, Clayton E. Linkous, Jr., M.D., at all times pertinent to this proceeding, has held a current and valid medical license issued by the Board of Medical Examiners of the Department of Professional Regulation. The Petitioner is an agency of the State of Florida charged with enforcing the requirements of Chapter 458, Florida Statutes, and appurtenant rules involving the licensing of physicians, the regulation of their licensure status and the enforcement of standards of professional practice of physicians it licenses to practice in the State of Florida. The Respondent received his medical degree from the University of West Virginia Medical School. Be entered the Navy and served a "rotating internship" at Bethesda Naval Hospital. He was on the staff at Bethesda Naval Hospital for approximately one year. The Respondent then came to Pensacola for Naval Flight Surgeon training and was ultimately assigned to Camp Pendleton, California. The Respondent later was assigned to Vietnam with the Marine Corps as a Flight Surgeon and General Surgeon. Upon concluding his tour of duty in Vietnam, the Respondent returned to the Naval Air Station in Pensacola where he was placed in charge of the Division of Physical Evaluation of Aviation Medicine, serving in that post for some two and a half years. The Respondent resigned from the service and opened a practice of emergency medicine at Sacred Heart Hospital in Pensacola, serving in that capacity for approximately four years. The Respondent then entered private practice in the areas of acute medicine and family practice, which practice he was engaged in at the time of the hearing. The Respondent is a member of the County Medical Society in Escambia County, the American Medical Association, Southern Medical Association, Association of Military Surgeons and a Charter Member of the American College of Emergency Physicians. The Respondent is current on continuing medical education requirements through September, 1983. In January of 1978, Mrs. Julie Hebert visited the Respondent with complaints of a recent weight gain of 7 pounds and sleeping long hours. Mrs. Hebert weighed approximately 101 pounds at that time. The Respondent treated Mrs. Hebert for sleeping long hours and for depression, for which he prescribed antidepressants as well as anorexiants, which are appetite suppressors. During his course of treatment of Mrs. Hebert on this and later occasions, the Respondent failed to record her height, which has a direct relationship to a determination of her ideal weight, although he was treating her to alleviate a supposed excessive weight gain. The Respondent also failed to take a psychosocial or neurological examination of Mrs. Hebert and thus, of course, failed to make a written record of any such examination or history. The Respondent made a diagnosis of obesity. The patient complained of a 7 pound weight gain and her weight was 101 pounds, but if a diagnosis of obesity is made, the usual and reasonable course of treatment for a physician engaged in family practice is to try and predict an ideal body weight or weight loss goal, interview the patient extensively with regard to diet habits, exercise habits and then try to make recommendations to modify those in order to alleviate the diagnosed condition of obesity. This should always be done before an anorexiant drug is prescribed and the appropriate standard of care for a patient with a diagnosis of obesity does not consist of merely prescribing anorexiants to suppress appetite. Anorexiants suppress the appetite control center of the brain. Their use can be helpful to suppress appetite during the first few weeks of treatment for obesity, but they must be prescribed as a part of a total program of weight control consisting of diet modification and exercise on a long-term basis. Anorexiants provide a diminishing return in their benefits in treating obesity because, as their use continues, their effectiveness diminishes and an increasing dose is required as a few weeks elapse. The need to increase the dosage to achieve the same effect of suppressing appetite, and therefore weight control increases geometrically. Thus, if their dosages continued at or near the originally prescribed amount, the anorexiant soon no longer has the effect of suppressing the patient's appetite and the patient has nothing helping him to lose weight unless an appropriate diet and exercise program was thoroughly discussed and prescribed. On the other hand, if anorexiant dosages are increased as their beneficial effect diminishes, then the serious side effects of anorexiant drugs come into play. Anorexiants cause an elevated pulse rate and an increased body temperature similar to that of an adrenaline response or "high active state." Anorexiants are amphetamines or "amphetamine-analogue" drugs, which, because of their stimulative effects, often cause cardiac arrhythmias and increasing dosages can often prove seriously harmful or fatal to a patient. Because of these potentially dangerous effects of anorexiant medications and because their use necessitates geometrically increasing dosages in order to remain effective in weight control, the use of such "amphetamine- family" anorexiants is inappropriate in a patient like Julie Hebert, particularly because of her age of 17 years, because of the potential for causing serious heart rhythm abnormalities and possible death, as well as the addictive potential of such increasing dosages. The use of anorexiants were especially contraindicated in the case of patient Hebert because no long-term diet and exercise modification program was discussed with the patient nor prescribed and the diagnosis of obesity, when the patient reported a recent weight gain of only 7 pounds and only weighed approximately 101 pounds on the first examination, was established to be incorrect. (Cohen deposition; Petitioner's Exhibit 2) The Respondent also diagnosed Julie Hebert, as suffering from depression. The appropriate standard of care in treating depression is a thorough consultation with the patient about depression, its causes and means for alleviating it. A family practitioner practicing an appropriate standard of care in dealing with depression should recommend counseling for the patient herself, as well as involving her family and should take an extensive psychosocial history of the patient's personal and family background in order to assist him in determining the causes of her depression. The Respondent failed to do this in this case. Instead he immediately prescribed two antidepressant medications, which, without the accompanying consultation and counseling and eliciting of a detailed history, can be a potentially dangerous deviation from the standard practice when dealing with such a 17-year-old patient. Antidepressant medication, when appropriately prescribed, requires approximately four weeks to exert its full, antidepressant effect. Its benefit is not immediate, but rather is a cumulative effect. This patient's antidepressant medications, however, were changed frequently. Two medicines were prescribed the first visit and two different antidepressant medications were prescribed on the next visit and still a third medication prescribed on the her third visit, all in the space of less than two months. In fact, on her third visit a major phenothiazine tranquilizer was prescribed when, according to the Respondent's notes, the patient seemed anxious and agitated. That type of medication is used to treat schizophrenia or a major psychosis. There is no psychosocial history in the case of Julie Hebert to indicate that she had or ever had a psychosis which would justify prescribing that drug, especially in view of the fact that it represented a third change from the previous course of antidepressant medications prescribed. The changing of antidepressant medications three times in less than two months is not a course of treatment followed by reasonable, prudent general practitioners or family practitioners in treating such a patient because an insufficient opportunity was provided for the initial medications prescribed to render their full beneficial effects before their use ceased. Further, the doctor prescribed three different amphetamine-family medications in less than three weeks and failed to keep any record of the amounts of any of those medications. The use of such amphetamine-family drugs or anorexiants has no therapeutic place in diet therapy, especially with a 17-year-old girl who only weighs approximately 101 to 105 pounds. On April 18, 1978, patient Gloria Brock visited Respondent at his office complaining of a weight problem. At that visit the Respondent failed to record the patient's height and failed to record an ideal body weight or any weight loss goals. No record was made of the patient's diet habits or exercise habits, nor the type of therapy he prescribed for her. The doctor did prescribe a substantial number of medications. He prescribed diuretics, thyroid medication and amphetamine-family anorexiants. The doctor prescribed Tofranil, an antidepressant; Valium, a minor tranquilizer; Oretic, a diuretic; Thyrolar, a thyroid hormone; Ionamin and Bacarate, both amphetamine analogue medications; and well as Midrin, a headache medication. The sole diagnosis underlying these prescriptions was the patient's weight problem. The doctor next saw this patient on May 9, 1978, at which time he refilled the prescriptions for the previous medications and added a prescription for Phenaphen #2, a narcotic analgesic and Didrex, a different diuretic medication. On that visit she had an additional complaint of mild muscle tenderness in her neck. On June 15, 1978, she came in complaining of additional problems involving miofasciculitis and vascular cephalgia (sore muscles and headaches). He refilled the previous medications, except the Oretic and Tofranil, and added a prescription for Elavil, which is a different anti-depressant from that previously prescribed. He also increased the dose of thyroid hormone. On July 17, 1978, she again visited the Respondent's office and he administered an injectable medication called Vernate, a decongestant and antihistamine combination. Vernate has no therapeutic purpose with a patient in Mrs. Brock's medical situation. The patient also received an injection of Keflex, as well as Comhistla and Ionamin injections. Keflex is an antibiotic. The Respondent had made a note on that date that he thought her ear canal was inflamed or infected. The Keflex was used, however, in conjunction with Terramycin, which is a brand of Tetracycline, the use of which in combination with Keflex is wholly inappropriate. The use of the antibiotic Keflex with the antibiotic Tetracycline is incompatible and the Tetracycline actually will impair the effect of the Keflex prescription. Comhistla is an antihistamine decongestant and Ionamin is a amphetamine-family anorexiant. On September 6, 1978, the Respondent prescribed to her Parafon Forte, a muscle relaxant; Triaprin DC, which is an analgesic containing synthetic Codeine; Histalet, an antihistamine and Minocin, an antibiotic. No record was made by the Respondent of any of these prescriptions. The next office visit was October 23, 1978. No complaints by the patient were recorded for that date, but some physical findings were noted such as her weight (121 3/4 pounds) and that her nasal mucus membranes were swollen. The patient received three injectable medications that date; Iatric, a multi- vitamin combination that is combined with Testosterone and Estrone. That medication is designed for geriatric use and has no therapeutic value in treating Mrs. Brock, a 38-year-old patient with no symptoms indicating its use. She was also injected with vitamin B-12. The only therapeutic indication for a B-12 injection is for pernicious anemia, which Mrs. Brock did not have. Vernate was again injected on that date. The Respondent also prescribed Brexin, another amphetamine-family anorexiant; another antibiotic (Erythromycin); Sinequan, an anti-depressant; and refilled Thyrolar, a thyroid medication. On November 15, 1978, Mrs. Brock came to his office complaining of a muscle spasm. At that time she was injected with Aristocort and Vernate. Prescriptions were also given on that date for Soma Compound, an analgesic- muscle relaxant combination. The next visit was January 18, 1979, when the previous medications were re-prescribed. The Respondent made no notes on that visit regarding the patient's complaints and no physical findings were recorded in his notes. The Respondent last saw this patient on January 30, 1979, and injected her with Lincocin, an antibiotic; Aristocort, a cortisone synthetic preparation; and Cofene, another decongestant-antihistamine combination. On that visit she complained of intermittent auxiliary or underarm swollen glands as well as swollen glands in the groin area (lymphnodes), nausea and weakness. Prescriptions for Vectrin, Elavil and Cofene were given on that date. Those are, respectively, antidepressants and an antihistamine decongestant. . . None of these medications were medically indicated for these complaints. The Respondent's records and notes made during this visit and his course of treatment of Mrs. Brock do not reflect an appropriate history, physical findings or amounts of drugs prescribed. Some of the later physical complaints by the patient during her course of treatment, such as nausea and weakness, are actually signs of misuse or overuse of the medications prescribed and yet the Respondent's later prescription practice and treatment of the patient does not reflect consideration of any adverse drug reactions or side effects. Patient, Vassie Johnson, came to the Respondent on November 7, 1977, complaining of a weight problem. The Respondent recorded her weight as 190 pounds and her age as 60 years and made no recordation of her height at that time as it related to her then present weight or her ideal weight. The Respondent prescribed Ionamin and Bacarate, two amphetamine anorexiants. He also prescribed Hygroton, a diuretic; Thyrolar, which is a thyroid hormone; Quibron Plus, a bronchial dilator; Triavil, an antidepressant. The Respondent diagnosed her problems as being chronic, obstructive pulmonary disease; peripheral vascular insufficiency; obesity; and Mitral Valve Prolapse, a disease or condition of the heart. When she came to the Respondent on this first visit, this patient was already taking the following medications: Triavil, an antidepressant; Donnatal, a gastro-intestinal anti-spasmodic; Dyazide, a diuretic; Inderal, an anti-hypertensive drug; Premarin, a female hormone replacement; Nicotinic Acid; and Librax, a gastro-intestinal anti-spasmodic. The patient had indicated on the personal history she supplied the Respondent that she had emphysema, that she had high blood pressure (hypertension), and that she had Mitral Valve disease of the heart. The prescription of amphetamine-family anorexiants are particularly dangerous for someone known to have heart disease and are contraindicated with a patient who has hypertension, as this patient did. This is because the stimulant effects of such drugs speed the heart rate, stress the heart muscle and elevate the blood pressure in someone who already has a problem with elevated blood pressure. Such a course of treatment with a patient such as Mrs. Johnson could have serious adverse health consequences for her, possibly even fatal ones. The standard treatment for obesity with a patient such as Mrs. Johnson is to do a standard medical history, including her diet and exercise history. The practitioner should then establish a program of diet and exercise habit modification appropriate to the patient. The doctor's records do not reflect that this was done with Mrs. Johnson. Catecholamine is a substance produced by cells in the nervous system which acts as a stimulant. Exogenous catecholamines are drugs that have that same effect. They are prescribed for persons with asthma or lung disease, but should not be used with amphetamine-family anorexiants. The Respondent however prescribed two amphetamine-family anorexiants on the same occasion that he prescribed Quibron Plus, a bronchodilator (catecholamines) which is clearly contraindicated in the manufacturer's recommendations. As noted above, amphetamine-family anorexiants can cause heart rhythm problems. On the very next visit, November 28, 1977, Mrs. Johnson complained of chest pain and Dr. Linkous' notation for that visit notes that it is relieved by nitroglycerin. He also notes, in addition to chest pain, that the patient had an occasional extra heart beat or altered heart rhythm. This is a known adverse side effect from the prescription of amphetamine anorexiants. Thus the Respondent, already having a history of the patient's heart problems before prescribing the anorexiants the first time, was supplied additional unequivocal evidence of the patient's heart condition by her complaints of chest pains and altered heart rhythm. In spite of this, on the next visit, on December 5, 1977, the doctor merely prescribed additional medications. Those medications were Hygrotin, a diuretic, P 200 (nature unidentified) ; Bacarate and Ionamin, the same amphetamine-family anorexiants once again. The heart symptoms she experienced at that time are consistent with the known side effects of the prescription of such amphetamine-family medications. Two days after the patient had complained of chest pains and occasional irregular heart beat, November 30, 1977, the Respondent admitted her to Sacred Heart Hospital of Pensacola. His diagnosis at that time consisted of ruling out ischemic myocardial disease, peptic ulcer disease, chronic obstructive pulmonary disease, hyperthyroidism. In his admission summary, the doctor made no record whatever of the medication already prescribed to the patient and which she was at that time taking. He merely indicated in his admission summary the medications the patient was already taking when she first came to him for her first visit. The subsequent office notes during the Respondent's entire course of treatment of this patient do not reflect the course of treatment in the hospital nor that she was ever hospitalized, which is a significant error of omission, as is the failure to record in the hospital admissions summary the medications the patient had been taking and was taking. On December 23, 1977, Mrs. Johnson returned to the Respondent complaining of dysphagia, meaning difficulty in swallowing. The doctor's records don't reflect that any prescriptions were given on that date. She again returned to the Respondent on February 13, 1978, and the doctor's notes indicate that the same medications were continued. In summary, there is no question that the care he provided these three patients was indeed quite dangerous and could or may have been substantially harmful to them. The Respondent has never been charged with a violation of statutory professional practice standards and has never been disciplined with regard to his licensure status.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence in the record and the candor and demeanor of the witnesses, it is, therefore RECOMMENDED: That the Respondent, Dr. Clayton D. Linkous, Jr., be found guilty of violating Subsections 458.1201(1)(m) and (k), Florida Statutes (1977), as substantially reenacted by Subsections 458.331(1)(t) and (h), Florida Statutes, and that his license be suspended for one (1) year, but with that suspension to be stayed and held in abeyance after 45 days of that suspension has been served, and that it be permanently abated after the Respondent demonstrates to the Board that he has successfully completed a continuing medical education course designed to enhance his skills regarding the appropriate use of drugs in medical practice and therapy, appropriate prescription practices and appropriate patient record-keeping and monitoring. DONE and ENTERED this 4th day of June, 1983, 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 June, 1983. COPIES FURNISHED: Harold E. Regan, Esquire The Whitehouse - Suite 3 203 North Gadsden Street Tallahassee, Florida 32301 Paul W. Lambert, Esquire 1114 East Park Avenue Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Nonroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION, Petitioner, vs. CASE NO. 81-1631 CLAYTON E. LINKOUS, JR., M.D., License No. 15233 Respondent. /
Findings Of Fact Respondent is a medical doctor, licensed to practice in Florida, and holds license number ME 0009310, issued by Petitioner. Respondent specializes in family practice and has been board certified by the American Academy of Family Physicians since 1974. Percodan is the manufacturer's brand name for oxycodone, which is a Schedule II controlled substance pursuant to Chapter 893, F.S. 2/ It is a drug used for the relief of pain, a synthetic analgesic, and is both a physically and psychologically dependent producing drug. It can cause drowsiness, urinary retention, nausea, vomiting, and interacts unfavorably with other sedative drugs, and is considered a depressant. On December 30, 1966, Evelyn Milstead, a 30 year old woman, came to Respondent's office complaining of nausea and a rash in her mouth. Respondent conducted a physical examination, took her medical history and thereafter prescribed tigan for the nausea. Ms. Milstead became a regular patient of Respondent's and he continued treating her for various ailments over a period of years. During the course of Respondent's treatment, Milstead developed a chronic urinary tract infection and kidney condition in which she passed kidney stones. On occasion Milstead was treated by Dr. Gillespie, a specialist in the field of urology for her kidney condition. In 1978, Respondent also referred instead to the Ochsner Clinic for evaluation of her urinary tract and kidney problems. She was evaluated at Ochsner Clinic and received prescriptions for darvocet, a pain medication, and keflex, an antibiotic, and was told that she would continue to have a chronic kidney problem. Over the years, Milstead was hospitalized several times by Dr. Gillespie for treatment of her kidney condition. The testimony of Dr. William H. Nass and Dr. Robert P. Johnson established that Respondent's initial prescriptions of percodan to Milstead were appropriate. However, Respondent's percodan prescriptions to Milstead eventually became inappropriate. Specifically, the prescriptions for 2,668 percodan tablets between August, 1980 and November, 1982, were established as excessive. On July 30, 1977, Bruce White, a 25 year old male, came to Respondent for medical treatment for headaches and thereafter returned to Respondent for treatment of various medical problems. Mr. White's wife, Vicki White, and their children were also seen by Respondent as their family doctor. On May 18, 1981, White came to Respondent complaining of neck and back pain from an automobile accident in which he also fractured his left lower leg. Respondent noted that White had been seen by a neurologist and an orthopedic surgeon for his head and leg. In addition to other medication, Respondent prescribed percodan to White for pain. White had also developed arthritis in his left leg, as a result of the car accident and fracture, and on one occasion was hospitalized for swelling of his left leg. Respondent referred White to Dr. Tippett, a neurosurgeon, concerning his headaches and to Dr. Graybiel, a rheumatologist, concerning his arthritis. However, White continued to see Respondent as his medical doctor because his work schedule on an offshore oil rig would only permit Saturday appointments with his doctor and Respondent's offices are open on Saturday mornings. White also found it difficult to pay the fees charged by specialists. Between May 8, 1981 and September 30, 1982, Respondent prescribed 780 percodan tablets for Bruce White. The testimony of Dr. Nass and Dr. Johnson established that Respondent's initial prescriptions of percodan to White were appropriate. However, the percodan prescriptions to White became inappropriate over time due to their excessiveness. The seriousness of this lapse is underscored by Respondent's failure to try other pain alleviating measures and failure to investigate abuse possibilities. On October 18, 1979, Vicki White, the wife of Bruce White, a 23 year old woman, came to Respondent's office seeking treatment. She complained of migraine headaches and stated that her father was in the hospital with cancer. She also stated that she had seen Dr. Eyser, a neurosurgeon, for her headaches. Respondent prescribed wygesic for her pain. She subsequently returned to Respondent for treatment of various complaints including chronic migraine headaches, colds, and a dislocated right shoulder. Initially, Respondent prescribed norcet for relief of this pain, and on July 31, 1981, first prescribed percodan for her migraine headaches. Respondent prescribed percodan on other occasions in response to her complaints of pain from migraine headaches and back strain. Respondent considered referring her to a neurologist for the headaches but White stated that she could not afford to see a specialist. Respondent prescribed 590 percodan tablets for Vicki White between July 31, 1981 and September 22, 1982. Percodan is an appropriate and acceptable medicine for the relief of migraine headaches, and Respondent's initial prescription of percodan to Ms. White was appropriate. However, his prescriptions became excessive over time since percodan is not to be used for long term treatment of migraine headaches. On September 7, 1982, M. D. Medlen, an Escambia County Deputy Sheriff, went to Respondent's office as an undercover police officer, under the assumed name of Donna Slay. She had been asked by Robert Powers, a narcotics officer with the Escambia County Sheriff's Department and Charles Deckard, an investigator with the Department of Professional Regulation, to go to Respondent's office in an undercover capacity and attempt to obtain a prescription for percodan. Medlen/Slay first gave general information to the receptionist, including identification, in the name of Donna Slay, chief complaint of a backache, previous illnesses, drug allergies, address, social security number, and insurance information. Medlen/Slay was shown to an examination room where her blood pressure and weight were taken by the nurse and a urinalysis was performed. Respondent then came in and asked Medlen/Slay what her problem was. She informed him that she had been pushed into a wall during a fight, and had injured her back. Respondent checked her pulse, did a range of motion test, and checked the alleged injured area by palpation. Each time Respondent pressed on the alleged injured area, Medlen/Slay told him it hurt. Respondent did not visually inspect the alleged injured area but asked Medlan/Slay if there was a bruise and she said no. In order to get the percodan, Medlen/Slay told Respondent that she had injured her back one other time and a doctor in Louisiana had prescribed percodan for that injury. Respondent asked how long ago Medlen/Slay had taken the percodan and she said one year ago. Respondent discussed the dangers of drug addiction with Medlan/Slay and then prescribed 20 tablets of percodan for pain and 30 tablets of indocin to reduce inflammation. Upon leaving Respondent's office, Medlen/Slay did not fill the prescriptions but turned them over to Deckard. Percodan is an acceptable medicine for back and shoulder pain. However, Respondent should have considered the possibility of fracture, visually examined the area to ascertain the presence of a hematoma (blood clot) and listened to the patient's chest to determine the presence of lung injury. Respondent did not perform an appropriate examination prior to prescribing percodan, and the prescription was therefore inappropriate. Respondent used poor judgment in his excessive prescriptions of percodan to the patients discussed herein. However, there is no evidence that Respondent prescribed the percodan for personal financial gain or that any patient was injured by Respondent's prescribing practices. The testimony of the expert witness established that the records maintained on these patients were inadequate. Frequently, the only notation for a given visit was the prescription for percodan, with no evaluation of the patient's condition. Further, Respondent's patient records did not even list all the percodan prescriptions issued. Thus, these records essentially reflect partial inventories of prescriptions issued, and do not justify the course of prescribing, which is important to the safe practice of medicine.
Recommendation Based on the foregoing, it is RECOMMENDED that Petitioner enter a final order placing Respondent on probation for a period of five years, require that Respondent practice under the supervision of another physician to be named by Petitioner during the initial year of his probation and that Petitioner restrict Respondent's license against prescribing Schedule II controlled substances while he is under such supervision. 4/ DONE and ENTERED this 24th day of April, 1984 in Tallahassee, Florida. R. T. CARPENTER, 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 24th day of April, 1984.
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
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
