The Issue Should the Board of Medicine (the Board) discipline Respondent's license to practice medicine in Florida, based upon an alleged failure in the level of care and treatment of J.P., his patient?
Findings Of Fact STIPULATED FACTS: Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes, and Chapter 458, Florida Statutes. The Respondent, whose address of record is 1834 SW 1st Avenue, Ocala, Florida 34474, was issued license number ME 56306. At all times material to this Complaint, the Respondent was a licensed medical physician within the State of Florida. Respondent specializes in pulmonology. Respondent was Patient J.P.'s attending physician. Respondent ordered a bronchoscopy and specimens that revealed possible Mycobacterium Avium-Intracellulare (MAI). The biopsies revealed signs of granulomalous infection as seen in MAI or tuberculosis (TB). During this (his) hospital stay, Patient J.P. was started on the drug ethambutol at 1600 mg daily. It is the manufacturer's recommendation that the dose of ethambutol, if started at 25 mg per kilogram per day, should be reduced to 15 mg per kilogram per day after 60 days. The infections (infectious disease) specialist saw Patient J.P. in his office on or about July 26, and August 8, 2000 and in his August 18, 2000 letter to Respondent, there was no mention or recommendation for a change in Patient J.P.'s dosage after two months on the ethambutol therapy. Patient J.P. was subsequently seen by the Respondent on October 23, and again on December 27, 2000, when Patient J.P. complained of eye problems. At this later visit Respondent immediately discontinued the ethambutol and referred Patient J.P. to an eye specialist. ADDITIONAL FACTS: Patient J.P.: On May 8, 2000, Patient J.P. was seen at Ocala Lung and Critical Care Associates (Ocala Lung and Critical Care) in Ocala, Florida. This practice is Respondent's Professional Association. The patient had been referred by Dr. Dave Metcalf. On that date the patient was seen by Respondent's associate, Poonan Warman, M.D. According to the note in the patient records for that date, the patient reported a complaint of "cough and cold" with no weight loss. (Petitioner's Exhibit No. 1, page 28) On May 23, 2000, the patient returned to Ocala Lung and Critical Care. Again Dr. Warman saw the patient. A note in the patient's chart describes J.P.'s condition on that date. (Petitioner's Exhibit No. 1, page 35) At that time Dr. Warman concluded that the patient had a mass in his left lung with right lung abscess. Dr. Warman scheduled a bronchoscopy and prescribed mediation. On June 13, 2000, Respondent first say Patient J.P. at Ocala Lung and Critical Care. At that time Respondent made notes in the patient's chart concerning the patient's condition. (Petitioner's Exhibit No. 1, page 49) Respondent assessed the condition as a system in the patient's right upper lobe, possible lung abscess. The note refers to the provision of an antibiotic, a CBC differential and CRP that was ordered. This was a follow- up visit for the bronchoscopy that had been performed by Dr. Warman. Cultures in association with the organism found through the bronchoscopy were pending. At that time Respondent's recommendation to the patient was to continue the antibiotic treatment of Augmentin as well as Clindamycin. The patient was to be seen back in a month's time, according to a typed note within the patient's chart bearing Respondent's signature. (Petitioner's Exhibit No. 1, page 48) In that same typed note it was noted that the bronchoscopy and the biopsy that had also been performed did not reveal malignancy but chronic inflammatory cells had developed. The type-written impression entered in the chart was right upper lobe cavitary lesion, most likely lung abscess. On this date Respondent concluded that the patient had bacterial infection in the lung and the lung abscess. Respondent wanted blood work done to monitor the side effects of the antibiotics being given. Respondent discussed the side effects of the medication with the patient as noted in the written entries in the chart. In relation to the antibiotic medications that were provided to Patient J.P., notes were made on June 14 and 20, 2000, in the patient records maintained by Ocala Lung and Critical Care, commenting on the efforts by the practice to assist Patient J.P. in obtaining those medications from that office and other doctors' offices because of his inability to pay for the medicine. (Petitioner's Exhibit No. 1, page 47) On June 27, 2000, Respondent saw Patient J.P. at the Monroe Regional Medical Center (the Medical Center) in Ocala, Florida, for a medical emergency. The Medical Center is a hospital. At that time the patient's chief complaint was a right-side chest pain. The patient was admitted to the Medical Center by Frank E. Reisner, M.D. The patient had called Respondent's office before his admission. Under the circumstances Respondent was concerned that the patient would not receive adequate treatment as an outpatient. It was recommended that the patient be admitted for inpatient hospital treatment of his lung abscess. On June 27, 2000, the emergency department note in the hospital record refers to the admission of Patient J.P. to the service of Dr. Mishra, an internist at the hospital. (Petitioner's Exhibit No. 1, page 354) Dr. Mishra had also spoken to Patient J.P. and told the patient to come to the hospital. Because the Patient J.P. had a lung abscess problem and had been seen by Respondent in the past, Respondent became responsible for the patient in the hospital upon the request of another physician. Respondent's decision to have the patient remain admitted for treatment of the lung abscess was made the same day the patient arrived at the hospital. Under this arrangement Respondent was the attending physician. On June 28, 2000, after receiving the chart for Patient J.P. from Respondent's office, to review the patient history and based upon results at the hospital that revealed the patient had possible MAI present in bronchial washings from a bronchoscopy performed in the hospital, Respondent decided to consult with Lee Prchal, M.D., who specializes in infectious disease and practices in Ocala, Florida. The reason for the consultation was that Respondent does not treat MAI. Decisions about the appropriateness of treatment for MAI, in Respondent's view, would best be made by a physician specializing in infectious diseases. Respondent did not feel comfortable treating MAI, in that he did not have sufficient knowledge about the condition and its treatment. If Dr. Prchal thought that the patient needed to be treated for MAI, Respondent expected that the other physician would be responsible for the care. With this in mind Respondent did not follow the patient as an attending physician would normally during the patient's stay in the hospital. Nonetheless, Respondent was aware that Patient J.P. had been prescribed ethambutol, also referred to as ethambutol hydrochloride or by the generic drug name Myambutol. Respondent understood that the medication had been prescribed initially in a setting in which it was uncertain whether the patient had a problem with MAI or tuberculosis. Dr. Prchal had written the order for ethambutol given to Patient J.P. in the hospital stay. Dr. Prchal intended to address any MAI with the medication. Dr. Prchal did not write orders for ethambutol upon the patient's discharge, although the patient continued to take the medication. Respondent did not order an initial visual acuity test when Patient J.P. was first prescribed ethambutol in the hospital stay. Dr. Prchal did not order visual testing to establish a baseline while the patient was hospitalized. At no point during the time Patient J.P. was treated with ethambutol did Respondent consider himself responsible in addressing MAI. Respondent did not believe that he had the duty to manage the treatment. He believed that Dr. Prchal was responsible while the patient was in the hospital and upon the patient's discharge. On July 19, 2000, following the Patient J.P.'s discharge from the hospital, Respondent saw the patient again in an office visit. Notes concerning that visit were made. (Petitioner's Exhibit No. 1, page 84) The notes reflect that the patient was doing well, and his cough had improved. Respondent's impression was that the patient had atypical TB and COPD. COPD refers to Chronic Obstructive Pulmonary Disease. At the time it was noted that the patient was advised to keep in touch with HRS for atypical TB. HRS refers to Health and Rehabilitative Services. In actuality, the Marion County Health Department was the health organization that Respondent had in mind. The comment on HRS is in association with an adult clinic in Ocala, Florida. According to a note in the patient record made by a member of Respondent's staff, someone previously had spoken to a person from the Health Department, who said that Patient J.P. did not have tuberculosis. This meant that the TB clinic with the Health Department would not follow his case for tuberculosis, but he could be followed in the adult health clinic for the condition he did have and that clinic should be able to help the patient with needed medication. (Petitioner's Exhibit No. 1, page 47) The adult health clinic is a general clinic affiliated with the Department of Health, and if seen in the general clinic Respondent believed that the patient could be provided needed medications. Patient J.P. had experienced difficulties obtaining needed medication in the past. As before, Respondent did not examine Patient J.P. in relation to visual acuity. The patient offered no complaints about his vision at this visit. On the July 19, 2000 visit Respondent did not consider reducing the ethambutol dosage for Patient J.P. The patient was referred to Dr. Prchal for a visit on July 26, 2000, in relation to MAI. Given the referral to Dr. Prchal, Respondent proceeded on the basis that Dr. Prchal was responsible for treating Patient J.P. for MAI. It was intended that the patient return to see the Respondent on October 23, 2000. Patient J.P. saw Dr. Prchal on July 26, 2000. Following that visit Dr. Prchal wrote the Respondent. The letter was dated August 18, 2000. (Petitioner's Exhibit No. 1, pages 87 and 88) In concluding remarks Dr. Prchal stated in the correspondence: Therefore, at this time, I would recommend continued ethambutol and biaxin for treatment of his MAI. The duration of his clindamycin will require your clinical judgment, but in view of his radiographic changes, it may require further prolonged administration. Respondent's reading of the correspondence was that Dr. Prchal would continue to monitor and be responsible for ethambutol therapy while deferring to Respondent to treat the lung abscess with Clindamycin. On October 23, 2000, Respondent saw Patient J.P. in Respondent's office. Handwritten notes were made by the Respondent during the visit, followed by typewritten notes for the patient's record. (Petitioner's Exhibit No. 1, pages 90 and 91) The patient records refer to the Respondent's perception that Dr. Prchal was treating MAI with multiple antibiotics. The note refers to COPD, lung abscess and MAI. Respondent asked the patient to discontinue Clindamycin and to continue Biaxin. Respondent also asked Patient J.P. to continue taking ethambutol. Respondent did not consider himself to be responsible for treating MAI with ethambutol. In the typed document for the patient record pertaining to the October 23, 2000 visit, it is indicated under the section dealing with Respondent's impression that the lung abscess healed resulting from treatment with clindamycin. At the same time the typed notes indicated that MAI would require long-term treatment. Although Respondent contends that Dr. Prchal would follow Patient J.P. routinely for MAI, the typewritten note describes Dr. Prchal's August 18, 2000 correspondence as a "final note." On October 23, 2000, the patient did not complain of any problems with visual acuity and no eye examination was ordered by Respondent. No specific inquiry was made concerning the patient's progress with the MAI. A follow-up appointment was scheduled for December 27, 2000. Patient J.P. kept that appointment. On December 27, 2000, Patient J.P. complained of an eye problem. He told Respondent that he was not able to see and that two weeks before he had seen an eye physician. As the patient record indicates, the patient complained to Respondent whether this problem with his vision was due to medicine. As a record on the patient care states, authored by Respondent, Respondent indicates "In response, [to complaints about the patient's vision] I have stopped his ethambutol." The impression in the patient record that was typed indicates as well "Ethambutol is being stopped today." This patient record is by way of a letter from Respondent to Dr. Prchal. (Petitioner's Exhibit No. 1, page 93) The letter goes on under the portion referred to as "Plan" to say, "I referred him back to you [Dr. Prchal] for evaluation of the disease process and then we will decide how long he will require the Biaxin." The discussion given thus far of the facts, includes the perspective of the Respondent as to his explanation of care for MAI in Patient J.P. The next part of the discussion is in relation to testimony by deposition by Dr. Prchal including his explanation of his care for MAI provided Patient J.P. Dr. Prchal has practiced in Ocala, Florida, since 1987. His primary specialty is infectious disease. His first encounter with Patient J.P. was at the Medical Center when the patient was referred to him by Respondent, the attending physician, to consult as an infectious disease specialist. When Patient J.P. was first seen, the working differential, as Dr. Prchal recalls it, was that the patient had an underlying chronic lung disease with a history of smoking and a family history of lung cancer. The patient had failed outpatient treatment and when seen could have underlying cancer and/or infections in his lung. Following the bronchoscopy performed on the patient in the hospital, Dr. Prchal wrote an order for ethambutol 1600 mg. The order was written on June 28, 2000. He wanted the patient to receive ethambutol because it was an antibiotic that is used for treating MAI. As Dr. Prchal describes, MAI is a germ in the family of tuberculosis. The patient received his first dose of ethambutol on June 29, 2000. The reason for prescribing 1600 mg of ethambutol was in recognition of the patient's weight. The dosage was presented in four tablets of 400 mg. Dr. Prchal's view of the prescription of ethambutol was that he had signed-off on the case before the patient was discharged from the hospital. At the same time, he considered the use of ethambutol to be open-ended and dependent upon the clinical response by Patient J.P. beyond his discharge. The concluding point for using ethambutol was to be decided by Respondent, in Dr. Prchal's perception, in that Respondent was the attending physician and the main person in charge of the case. Dr. Prchal's view of the choice of dosage of milligrams per kilograms of weight ranging from 15 mg to 25 mg per kilogram of weight, depends upon the person's clinical circumstance. The common starting dose is 25 mg per kg, in his view. Dr. Prchal's experience with ethambutol is that he had prescribed ethambutol to more than 50 patients. Dr. Prchal realized that optic neuritis is a potential side effect in the use of ethambutol. Dr. Prchal does not believe that baseline vision testing is necessary before providing ethambutol therapy. Dr. Prchal is familiar with the PDR concerning ethambutol, which he considers to be the manufacturers guidelines for use of that medication. In relation to the PDR reference to monthly testing for visual acuity during the use of ethambutol, particularly in dosages in the amount of 25 mg per kg, Dr. Prchal refers to the difficulty in having an ophthalmologist see patients for screening in the Ocala area and the difference of opinion among members of the medical community concerning screening. He does not believe that there is a specific standard to be followed in the community for screening. When Patient J.P. was in the hospital receiving his first dosage of ethambutol on June 29, 2000, Dr. Prchal indicated that baseline vision testing was not available in that setting and could only be done following the discharge of the patient. The frequency of testing beyond baseline testing would be on a case by case basis. According to Dr. Prchal, visual monitoring is part of the overall monitoring in the use of ethambutol. In Dr. Prchal's physician progress notes for Patient J.P. made on July 1, 2000, at the hospital, pertaining to ethambutol he referred to "appropriate monitoring." He then goes on to say that he "will sign off." He explains the latter reference to indicate that he was signing-off on the case. (Petitioner's Exhibit No. 1, page 121) Dr. Prchal saw Patient J.P. on July 26, 2000. At that time the patient was continuing with ethambutol. Dr. Prchal inquired about any visual symptoms. Patient J.P. responded that he did not have visual symptoms. The patient told Dr. Prchal that he had been referred to the Marion County Health Department. In Dr. Prchal's opinion the patient's medical condition at the time was better and the medicine seemed to be working. This is taken to mean that the ethambutol was working. Dr. Prchal saw Patient J.P. on August 8, 2000. This was their last visit. As with the visit on July 26, 2000, when Dr. Prchal saw Patient J.P. on August 8, 2000, the patient expressed no complaints about his vision. On August 8, 2000, Dr. Prchal had determined that the patient did not have tuberculosis, and medications to treat that disease were not necessary and could be discontinued. The medications for treating tuberculosis were IMH, Tyrazinamide and Rifampin. Dr. Prchal thought that ethambutol for treating MAI was still called for, together with Biaxin. Dr. Prchal did not have in mind a specific dosage of ethambutol. Being persuaded that Respondent was the attending physician overseeing the care, Dr. Prchal made known his views in the correspondence to Respondent on August 18, 2000. (Petitioner's Exhibit No. 1, pages 87 and 88) Dr. Prchal believes that the reason for Patient J.P.'s visits on July 26, 2000, and August 8, 2000, was Respondent's desire to know what medications still needed to be continued in treating the patient. EYE CARE The day before Patient J.P. saw Respondent on December 27, 2000, the patient had been at Ritz Eye Care. The reason for his visit was "check eyes-has trouble seeing." (Petitioner's Exhibit No. 1, page 192). On the visit to Ritz Eye Care he was seen by Daniel L. Ritz, O.D. Dr. Ritz consulted with Robert N. Mames, M.D., specializing in diseases and surgery of the Vitreous and Retina. Dr. Mames performed an ophthalmic examination and diagnosed the Patient J.P.'s condition as (1) decreased visual acuity in both eyes; (2) minimal nuclear sclerosis; and (3) history of lung abscess, Mycobacterium Avium. In his impression Dr. Mames said "etiologies include optic neuropathy secondary to ethambutol versus CAR syndrome (Canon-associated retinopathy), which is unlikely with no history of cancer." These findings were made in the report from Dr. Mames to Dr. Ritz dated January 16, 2001. (Petitioner's Exhibit No. 1, page 199) Patient J.P. was seen at the University of Florida, College of Medicine, Department of Ophthalmology, on March 23, 2001, by M. Tariq Bhatti, M.D., an assistant professor of the Department of Ophthalmology and Neurology. He indicates in correspondence to Mandouh H. Zeini, M.D., practicing in Ocala, Florida, "It appears that Mr. P. has bilateral optic atrophy. As you are aware, ethambutol is a well-known toxin to the optic nerves. However, I think it would be important to rule out other treatable causes of his optic atrophy. Therefore, I have recommended B-12, folate level, sedimentation rate, syphilis serology, ANA and an MRI of the brain and orbits." (Petitioner's Exhibit No. 1, page 224) On April 25, 2001, Dr. Bhatti saw Patient J.P. again. In turn, he corresponded with Dr. Zeini on that date. (Petitioner's Exhibit No. 1, page 227) With the negative work-up on the prior tests given Patient J.P., Dr. Bhatti wrote, "I suspect Mr. P.'s bilateral optic neuropathies are ethambutol- related. He has discontinued the use of ethambutol, therefore this should remain a static process with no visual loss." PHYSICIAN DESK REFERENCE: MYAMBUTOL The PDR in referring to MYAMBUTOL under the heading DESCRIPTION states: MYAMBUTOL ethambutol hydrochloride is an oral chemo-therapeutic agent which is specifically effective against actively growing micro- organisms of the genus mycobacterium, including M. tuberculosis. In the PDR under the heading INDICATIONS it is stated: MYAMBUTOL is indicated for the treatment of pulmonary tuberculosis. The PDR refers to CONTRAINDICATIONS where it states: MYAMBUTOL is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgment determines that it may be used. Under PRECAUTIONS the PDR states: . . . Because the drug may have adverse effects on vision, physical examination should include ophthalmoscopy, finger perimetry and testing of color discrimination. . . . In relation to ADVERSE REACTIONS the PDR states: MYAMBUTOL may produce decreases in visual acuity which appear to be due to optic neuritis and to be related to dose and duration of treatment. . . . Patients should be advised to report promptly to their physician any change of visual acuity. . . . Testing of visual acuity should be performed before beginning MYAMBUTOL therapy and periodically during drug administration, except that it should be done monthly when a patient is on a dosage of more than 15 mg. per kilogram per day. . . . In relation to INITIAL TREATMENT the PDR states: In patients who have not received previous antituberculosis therapy, administer MYAMBUTOL 15 mg. per kilogram. (7 mg. per pound) of body weight, as a single oral dose once every 24 hours. On the related subject of RETREATMENT the PDR states: In patients that have received previous anti- tuberculosis therapy, administer MYAMBUTOL 25 mgs. Per kilogram (11 mg. per pound) of body weight, as a single oral dose every 24 hours. . . . After 60 days of MYAMBUTOL administration, decrease the dose to 15 mg. per kilogram (7 mg. per pound) of body weight, and administer as a single oral dose every 24 hours. During the period when a patient is on a daily dose of 25 mg/kg monthly eye examinations are advised. EXPERT OPINION TESTIMONY: George Andrews Schoonover, M.D. has been licensed to practice in Florida since 1978. He practices pulmonary medicine in Jacksonville, Florida. He is certified in pulmonary medicine as well as internal medicine and has a sub-specialty in critical care medicine. For proposes of this hearing Dr. Schoonover was recognized as an expert in pulmonary diseases. To prepare himself for testimony at hearing he looked at the materials in Petitioner's Exhibit No. 1, which describes the care and treatment received by Patient J.P. during the relevant period. He also looked at the PDR in relation to MYAMBUTOL (ethambutol hydro-chloride). (Petitioner's Exhibit No. 3) His testimony was offered as a consultant for Petitioner. It supports Petitioner's attempt to impose discipline against Respondent's license. In interpreting the physician's progress note entered by Dr. Prchal on July 1, 2000, while Patient J.P. was in the hospital, which states "would sign off," Dr. Schoonover takes this to mean that Dr. Prchal will not be seeing the patient again, either in the hospital or as an outpatient, unless asked to formally consult at a future date. (Petitioner's Exhibit No. 1, page 121) Patient J.P. was discharged from the hospital on July 5, 2000, by Nagesh Kohli, M.D. Dr. Schoonover points out that the discharge summary explained to the patient in the discharge instructions that the patient, if experiencing any recurrence of symptoms, dyspnea, fever or questions or concerns, may call the Respondent. As well, the discharge instructions note that the patient was to follow up with Dr. Mitra in three to four weeks. (Petitioner's Exhibit No. 1, page 77) This instruction tends to coincide with the patient's visit to Respondent on July 19, 2000. Dr. Schoonover commented on the medications that Patient J.P. would continue upon discharge, in particular ethambutol 1600 mg q.d., part of the discharge summary by Dr. Kohli. This is as distinguished from the ethambutol Dr. Prchal had prescribed earlier in the hospital stay. In a patient medication record for Patient J.P. maintained by Respondent's practice, information is contained concerning ethambutol use over time. (Petitioner's Exhibit No. 1, page 9) Dr. Schoonover refers to the dosage of 400 mg four times per day, on July 19, 2000, October 23, 2000, and December 27, 2000, reflected in the patient record. Based upon the record, Dr. Schoonover assumes that Respondent was aware of the dosage of ethambutol for Patient J.P. upon these dates when the patient was seen, indicating a lack of change in the dosage over time. Dr. Schoonover commented upon the correspondence from Dr. Prchal to Dr. Mitra dated August 18, 2000. In his reading, Dr. Schoonover believes that the correspondence points out that Respondent was the physician of record from the standpoint of monitoring Patient J.P., and in treating the patient from the hospital discharge until the patient was seen by Dr. Prchal on July 26, 2000. In this connection notes made by Dr. Prchal concerning Patient J.P. in August 2000 were interpreted by Dr. Schoonover to indicate that the patient was receiving his prescriptions for medication from Respondent. (Petitioner's Exhibit No. 1, page 270) Dr. Schoonover also mentions the August 30, 2000 note in Patient J.P.'s records maintained by Respondent's practice, which describes a call by Dr. Prchal and his office note, taken to mean the correspondence directed to Respondent on August 18, 2000, in which Dr. Prchal requests Respondent to make sure that the patient has plenty of meds (medication) while Dr. Prchal was out of town through September 18, 2000. (Petitioner's Exhibit No. 1, page 89) That note maintained by Respondent in his practice indicates that the request was honored where it states, "Done." Dr. Schoonover assumes that the reference to meds would include ethambutol. Dr. Schoonover commented on the October 23, 2000 visit with Respondent as reflected in the note made on that date by Respondent (Petitioner's Exhibit No. 1, page 90), wherein it indicates that that patient is being continued on ethambutol. Dr. Schoonover believes that Respondent was responsible for monitoring that therapy and potential side effects and drug interactions associated with ethambutol. Dr. Schoonover commented on the December 27, 2000 correspondence from Respondent to Dr. Prchal, in which Respondent describes the complaint by Patient J.P. made December 26, 2000, about some eye problem, and whether the problem was due to medication. As Dr. Schoonover was aware, Respondent responded to those remarks by stopping the ethambutol. Dr. Schoonover was asked about his ability to form an opinion with a reasonable degree of medical certainty, whether the Respondent by his treatment of Patient J.P. practiced medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. He had an opinion. That opinion was that Respondent deviated from the standard of care, that the Respondent fell below the standard of care. Dr. Schoonover feels that deviation was in two areas. The first was the failure to order eye examinations for Patient J.P. The second reason was that the Respondent did not reduce the dosage of ethambutol after two months of therapy. Dr. Schoonover offered his opinion with the belief that Respondent was the attending physician in the hospital and continued to treat the patient beyond the patient's release from the hospital. Dr. Schoonover indicated that had the Respondent not ordered an initial eye examination be done, then at some subsequent point in the care the examination should have been ordered. Concerning reducing the dosage of ethambutol, Dr. Schoonover further explains his opinion that the dosage should have been reduced by Respondent after 60 days or at least determined why the specialist (Dr. Prchal) had not reduced it after 60 days. Dr. Schoonover concludes that Respondent could have taken steps to prevent the permanent visual impairment of Patient J.P. through an initial eye examination or subsequent follow-up eye examination, finding the problem early enough that this discontinuation of the medication would resolve the problem and promote improvement before permanent damage was done. Dr. Schoonover holds the opinion that Dr. Prchal also deviated from the recognized standard of care in his treatment of Patient J.P. in relation to ethambutol. He believes that both Respondent and Dr. Prchal were in a situation wherein they shared the care and they were both equally responsible and failed to meet the standard of care for the same reasons. In essence Respondent was treating the Patient J.P. for MAI as well as Dr. Prchal. In his testimony Dr. Schoonover is less precise in his opinion concerning the responsibility for a physician to order an initial eye examination for Patient J.P., testifying that it was someone's responsibility. He then goes on to say that it was several persons' responsibility and that Respondent and Dr. Prchal were among those persons. They are the persons discussed as well as Dr. Kohli. Finally, in order to find a deviation from the standard of care by Respondent, Dr. Schoonover believes that it is necessary to show that the patient had diminished visual acuity more probably than not connected to ethambutol. His reading of the April 25, 2001 correspondence from Dr. Bhatti in particular, leads him to believe that there was a connection between the use of ethambutol and bilateral optic neuropathies as described by Dr. Bhatti. (Petitioner's Exhibit No. 1, page 227) Raymond L. Parker, Jr., M.D., has been practicing in Florida since 1976. His current practice is with Pulmonary Physicians of South Florida in South Miami, Florida. He specializes in internal medicine, pulmonary disease and critical care. He is board certified in all specialties. He testified by deposition in behalf of Respondent as an expert, in particular, in relation to his specialty in pulmonary diseases. (Petitioner's Exhibit No. 2) In the deposition the parties stipulated that the witness was an expert in pulmonary diseases. That stipulation is accepted. In preparing to offer his opinion concerning the care provided by Respondent to Patient J.P., Dr. Parker had exposure to the deposition of Respondent, the deposition of Dr. Prchal, the deposition of Dr. Kohli, medical records of Dr. Prchal, Frank's Pharmacy records, medical records of Dr. Leslie Husband, medical records of Beatriz X-Ray and Imaging Center, medical records of Dr. Zeini, medical records of Dr. DiLorenzo, medical records of the Marion County Department of Health, medical records of Express Care of Belleview, and medical records of the Monroe Regional Medical Center. Dr. Parker also had exposure to records related to Patient J.P., part of Respondent's office practice. Dr. Parker comments on the bronchoscopy performed by Respondent on June 29, 2000, while Patient J.P. was in the hospital, in which the bronchoscopic specimen showed no endoscopic evidence of malignancy. Based upon the results of the bronchoscopy in the hospital and an earlier bronchoscopy performed a Dr. Warman on June 7, 2000, Dr. Parker was persuaded that the patient was going to be treated for MAI based upon cultures that grew out from the procedures. Further, Dr. Parker refers to the discharge diagnosis when Patient J.P. left the hospital, where it is stated that the patient had atypical tuberculosis, MAI, in addition to a right-upper lobe abscess and COPD. Dr. Parker's refers to the progress note dated July 1, 2000, when Patient J.P. was in the hospital, made by Dr. Prchal, in which Dr. Prchal recommends 400 mg tablets, four times daily of ethambutol, totaling 1600 mg, as being part of a treatment for TB and MAI pending AFB culture results. Dr. Parker's reading of the note by Dr. Prchal calling for "Appropriate monitoring. Will sign off," in the context of other materials reviewed by Dr. Parker, meant that Patient J.P. was being referred to the tuberculosis health center and those persons in that facility would manage the tuberculosis and MAI issue in the future. Dr. Parker refers to information in the patient records where the wife of Patient J.P. contacted a social worker leading to the patient being informed that the tuberculosis unit did not treat MAI but that an attempt was being made to make an appointment for Patient J.P. to be seen at the adult clinic. Ultimately, Dr. Parker interprets the information he reviewed as indicating that Patient J.P.'s wife decided that an appointment needed to be made with Respondent resulting in the appointment on July 19, 2000, between the patient and Respondent. Between July 1, 2000, when Dr. Prchal wrote his "sign off" note and July 19, 2000, when the patient was seen by Respondent, Dr. Parker expressed the opinion that Respondent and Dr. Kohli were the attending physicians for Patient J.P. The prescription recommendations upon discharge would have been the responsibility of Dr. Kohli because he discharged the patient. According to Dr. Parker this included ethambutol. Dr. Parker is familiar with the PDR. He does not consider it to be an authoritative source for information among doctors. He considers that the information contained in the PDR was written years before. Consequently, it is not authoritative or up to date. Dr. Parker prescribes ethambutol for his patients but rarely. He has a special interest in MAI. He is aware of the recommendations within the PDR pertaining to visual testing and dosage for ethambutol. He considers some of the recommendations for using ethambutol to be controversial. For example, he does not recommend his patients get monthly monitoring for their vision. Instead, he recommends that they watch out for problems. He considers that this approach is the general consensus in the community where he treats patients. Specifically, Dr. Parker does not question the prescription of 25 mg per kg of patient weight for the Patient J.P. when ethambutol was first prescribed. The dosage points to the patient loosing weight, fevers and sweats, not doing well and the need to "jump on him or he would just wither away." Dr. Parker does believe that there should have been an eye test when starting the patient on ethambutol. Dr. Parker in his understanding perceives that when Dr. Kohli discharged the patient from the hospital, Dr. Kohli believed that the patient would be attending the TB Clinic for treatment and monitoring, to include baseline studies for visual acuity. Dr. Parker in his opinion looks upon the suggestion in the PDR that the dosage of ethambutol be changed over time as being a guideline and that the proper treatment is in view of the clinical needs of the patient. If the patient is improving the dosage can be reduced. If he remains very sick, he would not necessarily reduce the dose. Concerning the maintenance of 25 mg per kg over periods of three, four, five, or six months Dr. Parker says that under appropriate circumstances the maintenance of 25 mg per kg of patient weight is acceptable. He does not offer his opinion concerning this case. Concerning the prospect for reducing the dosage, Dr. Parker's review of the records does not lead him to a conclusion one way or the other. When patients are maintained on 25 mg. per kg. of patient weight, Dr. Parker expresses the opinion that more frequent eye testing is in order. If the dosage is less than that amount he would not recommend that a patient have repeat eye testing but that the patient be cautioned to quickly advise the doctor about changes in vision and or visual fields or color vision. From his review of the records Dr. Parker was aware that the patient was maintained on ethambutol 25 mg per kg of weight for approximately six months and no eye tests were provided during that period. Dr. Parker interprets the correspondence from Dr. Prchal to Respondent dated August 18, 2000, as a guiding letter for addressing Patient J.P.'s MAI, leading to the belief by Dr. Parker that Respondent deferred to Dr. Prchal in the treatment of MAI with ethambutol following that correspondence. Overall Dr. Parker does not believe that Respondent was treating Patient J.P. for MAI and had no experience with the drug ethambutol as part of that care. This meant that Dr. Parker does not believe that Respondent was addressing the MAI issue or ethambutol. Dr. Parker interprets the note in Respondent's office practice where on August 30, 2000, the call was received from Dr. Prchal referring to the office note of August 18, 2000, from Dr. Prchal. That request asks that the patient have plenty of meds while Dr. Prchal was out of town until September 18, 2000. This indicates that Dr. Prchal could not write the prescriptions and that he was requesting Respondent's office to handle the writing of prescriptions. This is not seen by Dr. Parker as turning over the management of the patient in reference to the prescriptions. In Dr. Parker's view, when consultants prescribe medication, the attending physician does not have a standard of care obligation to hold the knowledge about these drugs prescribed by the consultant for the patient. The attending physician relies upon the consultant for guidance on the drugs and any questions need to be followed up with the consultant, according to Dr. Parker. In this case he goes on to describe the expectation, upon the discharge from the hospital, that the patient would be seen by a clinic where the attending physician felt there would be necessary expertise. Dr. Parker reached an opinion on standard for care issues concerning Respondent's treatment and care of Patient J.P. His opinion is that Respondent met the standard of care because he was the treating physician limited to the lung abscess and COPD. Dr. Parker interprets the results of the July 19, 2000 visit to Respondent to be one in which Respondent realized that the patient was not going to be seen at a tuberculosis health clinic, resulting in Respondent referring the patient back to Dr. Prchal for management of MAI. Dr. Parker attaches importance to the August 18, 2000 letter from Dr. Prchal to Respondent, in which Dr. Prchal indicates a treatment plan for MAI and Respondent defers to that judgment. At the inception Dr. Parker believes Respondent was acting appropriately to refer Patient J.P. to Dr. Prchal, an infectious disease expert. Concerning the need for a baseline eye examination to be performed when ethambutol is being started, Dr. Parker thinks that is necessary. However, the physician managing the care with respect to the MAI and who ordered the medication is responsible for ordering the initial eye examination. In this case that would have been Dr. Prchal. Any follow-up eye examinations on a periodic basis would be the responsibility of the physician with a special interest in management of atypical mycobacterial disease, with some understanding of the various drugs involved, to include ethambutol. Dr. Parker believes that additional eye examinations are needed when continuing the dosage of 25 mg per kg of patient weight. Given the continuing dosage over time, Dr. Parker believes that Dr. Prchal was responsible for ordering subsequent eye examinations. In relation to the suggestion in the PDR that around 60 days the dosage of ethambutol be reduced, Dr. Parker believes that it is dependent upon the clinical response of the patient. Sometimes the dosage would be reduced earlier, sometimes later. The judgments concerning dosage would be that of the expert familiar with the MAI and drugs used to address it. SUMMARIZING FACTS: Respondent's explanation of the availability of the adult clinic in Ocala, Florida, to address Patient J.P.'s need for medications and other services only establishes that availability. It does not establish what was done at the clinic, if anything, in terms of treatment for MAI through the use of ethambutol and related vision tests. There is no proof that anything transpired at the adult clinic to treat MAI, or test for visual acuity. Whatever may have been offered to the patient in treatment and care by the adult clinic, it does not change the fact that Respondent and Dr. Prchal were involved with the treatment for MAI, to include the need to properly use ethambutol. Having considered the facts found concerning the care provided Patient J.P. by Respondent and Dr. Prchal and the opinions by the parties' experts Dr. Schoonover and Dr. Parker, Respondent has failed to practice medicine with the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Dr. Prchal was responsible for prescribing ethambutol while Patient J.P. was in the hospital. Consequently Dr. Prchal was responsible for testing initial visual acuity for the patient. The initial treatment provided was upon a request to consult made by Respondent. Dr. Prchal was also responsible for establishing the initial dosage for the patient. When the patient was discharged from the hospital, Dr. Prchal was no longer responsible for the treatment from July 5, 2000, the discharge date until July 26, 2000, when called upon again by Respondent to consult. When Dr. Prchal saw Patient J.P. on July 26, 2000, and August 8, 2000, it reestablished his responsibility but only temporarily. The treatment was turned back to Respondent as established in the correspondence following the second consult. That correspondence was dated August 18, 2000, from Dr. Prchal to Respondent involving ethambutol and its use in treating Patient J.P. Respondent had responsibility for Patient J.P. in relation to ethambutol following the patient hospital discharge and upon the visit by Patient J.P. to Respondent's office on July 19, 2000. Respondent briefly deferred to Dr. Prchal as a consultant on July 26, 2000, until he received the correspondence from Dr. Prchal dated August 18, 2000. Beyond that point in time, Respondent was responsible for Patient J.P.'s use of the medication ethambutol. This responsibility was evidenced in the Respondent's transcribed office note dated October 23, 2000, when the Patient J.P. was seen on a follow-up visit. It refers to the final note from Dr. Prchal dated August 18, 2000 and the continuation of ethambutol for the patient. It describes the need for the patient to continue on ethambutol for a year or so. On December 27, 2000, when Patient J.P. was next seen by Respondent in the office, the patient complained of an eye problem. In response Respondent "stopped his ethambutol" as of that day. During the time that Respondent was responsible for Patient J.P., related to the use of ethambutol by that patient, he was expected to make a clinical judgment about the proper dosage, but not necessarily at a two-month interval. There is no indication that he made any judgment. More significantly, given allegations in the Administrative Complaint, Respondent should have arranged periodic testing of visual acuity, while he was responsible for the use of ethambutol in treating Patient J.P., having failed to reduce the dosage from 25 mg per kg of body weight. Respondent's failure to meet the standard of care is not excused by Dr. Prchal's conduct when treating Patient J.P. with ethambutol. Respondent's belief that Dr. Prchal was all together responsible for treating Patient J.P.'s MAI with ethambutol and other medications is not accepted, realizing that to some degree Respondent undertook the treatment whether capable or not. Finally, there was no proof in this record concerning the local Department of Health, adult clinic providing treatment to Patient J.P. for MAI, to include judgment about the dosage of ethambutol and test for visual acuity. Absent such proof the responsibility fell entirely to Respondent and Dr. Prchal at various times. Their stated assumptions concerning the role, if any, played by the Department of Health, adult clinic in treating Patient J.P. without proof are unavailing and create no defense for their conduct. DISCIPLINARY HISTORY In the case of Department of Health, Petitioner vs. Purushottam Mitra, M.D., Respondent, DOH Case No. 1999-58979, a Final Order was entered. This Final Order was based upon a Recommended Order in Department of Health, Board of Medicine, Petitioner vs. Purushottam Mitra, M.D., Respondent, DOAH Case No. 01-2069PL. The Final Order concluded that Respondent had violated Section 458.331(1)(m), Florida Statutes, pertaining to maintenance of patient records justifying a course of treatment for a patient. It imposed an administrative fine amounting to $5,000.00. Respondent was also reprimanded by the Board. (Petitioner's Exhibit No. 4)
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes (2000), imposing an administrative fine of $10,000.00, and issuing a written reprimand. DONE AND ENTERED this 25th day of February, 2005, in Tallahassee, Leon County, Florida. S CHARLES C. ADAMS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of February, 2005. COPIES FURNISHED: Irving Levine, Esquire Judith Law, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Michael R. D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A. Bank of America Center, Suite 1000 Post Office Box 2753 Orlando, Florida 32802-2753 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue 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, Rosalind Clarice Stratton, is a registered nurse with the Florida State Board of Nursing and holds license No. 48493-2. Testimony elicited during the course of the hearing revealed that the Respondent, while employed as an R.N. at the Morton F. Plant Hospital, Clearwater, Florida, converted to her own personal use 25 mg. of compazine. During early June, 1975, the administrator at Morton F. Plant Hospital experienced a pilferage problem and retained the services of the Wackenhut Corporation, a private detective agency, to assist it in alleviating the pilferage problem. In so doing, one of Wackenhut's agents was employed under the guise of an orderly who created an artificial shortage in the narcotics bin. On that date, June 12, 1975, Respondent noted that three ampules of demerol were missing from the narcotics bin and in an attempt to correct the shortage, she transcribed erroneous narcotic counts on the administration medication charts for the two preceding days. During the same period, Respondent had in her possession an ampule of compazine which she admitted taking from the narcotic cart because she was experiencing severe headaches. These admissions were brought out during the course of the hearing. In a letter dated April 4, 1976, to the Board, Respondent admitted that in the past drugs had been a problem however she indicated that she would like to resume the practice of her nursing profession. Evidence reveals further that on October 25, 1975, Respondent signed out on the narcotics chart for 50 mg. demerol and 25 mg. of phenogram for patient Arthur Bonde while there was no outstanding doctor's order for such. An examination of the hospital records produced at the hearing revealed that Respondent noted that she had administered the drugs to patient Bonde. On October 28, 1975, pursuant to doctors orders, Respondent charged out 50 mg. of demerol and 25 mg. of vistaril and charted as having administered only 50 mg. of demerol. She failed to administer the 25 mg. of vistaril nor did she offer any explanation as to the disposition of the vistaril. Similar infractions of Mrs. Stratton's conduct in failure to follow doctors orders occurred on October 22 and October 29, 1975. On November 13, 1975, on three occasions, Respondent failed to follow the hospital's procedure for destruction of controlled drugs by having a cosigner to verify and confirm the destruction of narcotics. Testimony revealed that the hospital, in regulating the destruction of controlled substances, required that a cosigner be present to sign and verify that in fact excess amounts of narcotics are not accumulated by employees for illegal purposes. Mrs. Joyce Billings, R.N., Director of Nursing for Tarpon Springs General Hospital for approximately two years, testified that charting is important in the administration of medication since most narcotics are administered on an as needed basis. She testified that occasionally nurses are relieved from duty and when the narcotic controls are not properly maintained overdoses could occur. She further stressed the fact that the failure to properly document or chart is considered a departure from the hospital's established procedure for maintaining records for controlled drugs. On December 9, 1975, Respondent was assigned to care for a critically ill patient. Mrs. Billings, during her regular rounds, stopped in to check on the patient assigned to the Respondent. She found that the patient was uncomfortable and that the control and output of the intravenous fluid to which the patient was being administered was not being monitored by Respondent. She testified that Mrs. Stratton was sitting in a chair in a slouched fashion and that her speech was slurred. Respondent also appeared generally unconcerned about the patient's welfare. This matter was called to the Administrator's attention who in turn contacted Respondent's supervisor who relieved her from duty due to her inability to perform in a satisfactory manner. Based on the foregoing findings of fact, I make the following:
Recommendation Based on the foregoing findings of fact and conclusions of law, I hereby recommend that in view of the seriousness and the repeated violations of the licensing law by the Respondent, that her license to practice as a registered nurse be revoked. RECOMMENDED this 30th day of June, 1977, in Tallahassee Florida. JAMES E. BRADWELL, Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Julius Finegold, Esquire 1005 Blackstone Building Jacksonville, Florida 32202 Mrs. Rosalind Clarice Stratton 1388-1/2 Palmetto Street Clearwater, Florida 33515 Mrs. Geraldine B. Johnson 6501 Arlington Expressway Building B Jacksonville, Florida 32211
The Issue The issue to be resolved in this proceeding concerns whether the Respondent is guilty of certain alleged violations of Section 458.331(1)(m), (q), and (t), Florida Statutes, concerning his treatment of one patient during 1984 and 1985 and, if so, what penalty is warranted.
Findings Of Fact The Respondent, Samir Najjar, M.D., is a licensed physician in the State of Florida, having been issued License No. ME0041782. He has been licensed as such at all times pertinent hereto. He received his medical degree from the University of Mexico in 1978. He performed an internship and residency in internal medicine at the Greater Baltimore Medical Center, completing that in 1981. He then completed a fellowship in pulmonary medicine at Wayne State University in Detroit, Michigan, in 1983. He is board certified in internal medicine and holds a Ph.D. in pharmacology and toxicology from Howard University in Washington, D.C. Pharmacology is a specialized field of study in drug pharmacology. It includes the study of chemistry, the effects and uses of drugs, including their toxicology, the origin and nature of drugs, and the pharmacodynamics of drugs. A pharmacologist also studies the effects of drug combinations and their effects on various illnesses and on the body generally. The patient involved in this proceeding is an adult male, who was born on March 4, 1950. He had a long history of reactive, obstructive airway disease, beginning at the age of 17 months to approximately 14 years of age. Between the ages of 14 and 30, the condition alleviated substantially so that he only had very occasional shortness of breath, which could be treated with bronchodilator inhalers. In April of 1980, however, the patient suffered an acute onset of shortness of breath, which condition worsened. He was treated by physicians with a course of Prednisone, an oral steroid medication, for some two to three weeks. This was prior to his being treated by the Respondent. The patient’s condition improved with the Prednisone therapy, but he experienced increasing shortness of breath one to two weeks after terminating that therapy. His shortness of breath become acute, resulting in a respiratory arrest and coma in May of 1980. The patient experienced a hypoxic seizure (lack of oxygen) and was hospitalized at St. Vincent’s Hospital in Jacksonville, Florida, for approximately seven days. Between April of 1980 and July of 1984, he was hospitalized 12 to 15 times for exacerbations of the asthma condition. During this time, he required intubation, or the placing of a breathing tube in the trachea, due to respiratory arrest on three or four occasions, the last one being in December of 1983. The patient has clearly been steroid dependent, with outpatient doses ranging from 5 milligrams four times per day of Prednisone to 35 milligrams twice per day of Medrol through September of 1984. Between July and September of 1984, the patient was receiving 35 milligrams twice per day of Medrol, also an oral steroid. The patient was primarily treated by Edward A. Mizrahi, M.D., between June of 1984 and June of 1985. Dr. Mizrahi is an allergist in Jacksonville, Florida. Prior to that time, he was treated by Irwin Schneider, M.D., a pulmonologist in Jacksonville, Florida. Upon initial presentation to Dr. Mizrahi, the doctor felt that the patient had severe steroid-dependent bronchial asthma with corticosteroid side effects. Patients who have life- threatening asthma are typically treated with anti-inflammatory medications, such as corticosteroids. Severe asthmatics can have life-threatening risks from their condition and will die, on many occasions, without the administration of steroid medications. Thus, such patients must take these medications to survive. Steroids have significant adverse side effects, including “cushinoid features”, development of cataracts and the development of osteoporosis. Despite such adverse side effects, the use of corticosteroids may be necessary in order to simply allow the patient to survive. The subject patient was in such a category. The patient suffered from many of the side effects from long-term steroid use. Dr. Mizrahi noted compression fractures of the spine, cataracts, peptic ulcer disease, and weight gain during his initial evaluation of the patient on June 11, 1984; and on October 10, 1984, noted cushinoid appearance or features. This was before the patient was ever seen or treated by the Respondent. On August 20, 1984, Dr. Mizrahi arranged for the patient to be evaluated at the National Asthma Center (Center) of the National Jewish Hospital and Research Center in Denver, Colorado. This is a specialty facility for the treatment of asthma and is commonly referred to as a “court of last resort”, where pulmonologists refer patients with difficult asthmatic conditions which have not as yet responded satisfactorily to treatment regimens. Between September 12, 1984 and September 16, 1984, the patient was evaluated and treated at the Center. The Center noted the patient’s long history of severe asthma and resultant steroid dependency. Upon initial evaluation, the physicians at the Center felt that the patient would probably require continuing steroid therapy, but they did attempt to reduce the steroid dosage. The attempt to reduce the steroid dosage in the patient was unsuccessful, and the Center ultimately had to increase the steroid dosage. The patient was discharged from the Center on an oral steroid medication, Medrol, 20 milligrams, alternating with 40 milligrams, four times per day. This is considered a high dose of steroid medication and was reluctantly arrived at and prescribed by the physicians at the Center after they made bona fide attempts to wean the patient from steroids to the extent possible. During his hospitalization, the physicians at the Center noted that the patient gave a “convincing history for ischemic heart disease”. They suggested an investigation to determine the presence of this condition. Upon the patient’s return to Jacksonville, Florida, he continued to be treated by Dr. Mizrahi and continued to receive oral steroid medication in high doses. Additionally, he was receiving Halcion, Adivan, Fiorinal, and Fastin. The Respondent first saw the patient on June 13, 1985 upon a referral from Dr. Samara, a urologist in Jacksonville, Florida, who had some contact with the patient. The Respondent took an extensive history from the patient, including a list of the current medications he was receiving from Dr. Mizrahi, which then included Medrol, 24 milligrams, four times per day, with a bolus of Medrol as needed of 60 milligrams four times per day for 48 hours, followed by 30 milligrams four times per day for two weeks. The patient was also receiving Halcion at 0.25 milligrams at bedtime and Adivan at 2 milligrams. The Respondent had the impression that the patient suffered from asthma and possibly from coronary artery disease. Due to the possibility of coronary artery disease, which had been raised during the admission at the Center, the Respondent hospitalized the patient from June 17, 1985 to June 22, 1985 at St. Vincent’s Medical Center in Jacksonville, Florida, to investigate the coronary situation. During this hospitalization, an extensive history and physical were performed, including a neurological examination of the patient. A cardiac workup was performed by consulting cardiologist, Joel Ferree, M.D. This included a cardiac catheterization performed by Dr. Ferree, which indicated that the patient had normal right ventricular function, no significant arteriosclerotic lesions, and no significant artery response to adrenergic agonist agents. The cardiac catheterization reported normal left ventricular function. The cardiac catheterization report ruled out any cardiomyopathy. During this hospitalization, the Respondent also ordered x-rays of the cervical and thoracic spine. The x-rays revealed “mild, old compression deformities of the eighth and ninth thoracic vertebral bodies, with no change since a previous examination on November 30, 1983”. This x-ray report was consistent with the previously- reported compression deformities, or compression fractures, which are the result of osteoporosis. Osteoporosis leaves the bones weak, with loss of trabeculation. The patient’s vertebra were already being crushed as of June of 1985, when the Respondent undertook his care. At the time of discharge from this hospitalization, the Respondent recorded that he would like to wean the patient off steroids over several months. The Respondent continued to treat the patient through April of 1989. During this period of time, the asthma was reasonably controlled with the use of steroid medications and bronchodilaters. Unlike the previous few years, the patient only required hospitalization for treatment of exacerbation of asthma symptoms on one occasion, on November 7, 1985. During this period of treatment, he never had a respiratory arrest and intubation was never required. The Respondent would wean the patient from the use of steroids during this period of treatment when the symptoms allowed. When the symptoms were exacerbated, he would provide prescriptions for corticosteroids so as to address the patient’s condition. The Respondent made numerous attempts to wean the patient off high-dose steroid medication, but the patient’s condition would not permit a cessation of it. The fact that the Respondent was unable to wean the patient from steroids is not surprising to physicians who treat such a condition. It is not a deviation from the accepted standard of care. The patient had a very significant case of asthma, which was life threatening, as demonstrated by the records of not only the Respondent, but the prior treating physicians. His asthma was so significant that he had to receive steroid medication, despite the significant side effects caused by such medication, in order to insure survival. During the course of treatment, the Respondent also treated the patient for cervical strain and low-back pain. His compression fractures were a source of great pain, justifying the prescription of narcotic analgesics. The Respondent’s treatment for these conditions included physical therapy, paralumbar trigger point injections, biofeedback, TENS Unit, ice packs, as well as drugs, including muscle relaxants and analgesics. The Respondent also referred the patient for examination by orthopedic physicians and neurologists. These efforts were appropriate and within the standard of care. The prescriptions for Flexeril, Fiorinal, Lortab and Tylox and other medications for the control of back pain and muscle spasms were appropriate and under the circumstances of this severely-distressed patient, were within the standard of care. The Respondent, on occasion, prescribed medications for control of insomnia, including Halcion. These same medications had previously been prescribed for the patient by Dr. Mizrahi for the same condition and were appropriate prescriptions. The corticosteroids and other medications used to control asthma can produce a side effect of insomnia. This manifestation must be treated for the benefit of the patient. The prescriptions for Halcion were appropriate and within the standard of care. An additional side effect of steroid medication is weight gain. The Respondent advised the patient regarding dietary control for his weight to alleviate such a problem. The patient, however, exhibited substantial weight gain. Therefore, the Respondent prescribed a limited amount of Fastin, an appetite suppressant. Physicians must use medications such as Fastin with caution on patients with significant hypertension. The patient’s blood pressure, however, was not significantly elevated; and his blood pressure was being monitored during his use of Fastin. The use of Fastin by this patient did not cause a significant increase in his blood pressure. Fastin is a sympathomimetic amine. It is not a true amphetamine. It is appropriately prescribed for weight control and this patient had exhibited an increase in weight, doubtless due to a side effect of the steroid medications. Increased weight in the patient was medically significant because he already had compression fractures of his vertebrae caused, no doubt, by osteoporosis, also attributable to side effects of steroid medications. Increased weight could exacerbate his skeletal problem and cause additional pain. Increased weight is also dangerous for patients with asthma, in any event, because it severely taxes the respiratory system and can make intubation, if necessary, more difficult. The Respondent’s prescriptions for Fastin were shown to be appropriate and within the standard of care, as demonstrated by the expert testimony of Dr. Miller and the other testimony in evidence offered by the Respondent. During treatment of the patient, the Respondent prescribed Adivan also. Adivan is a muscle relaxing drug, and it was shown to be appropriately within the standard of care for physicians confronted with a patient with the multiple problems exhibited by this one. Although there can be some concern about mood alteration under certain circumstances with the use of Adivan and perhaps to some extent with Halcion, the Respondent did perform mental status examinations and referred the patient for evaluation when indicated. During his treatment of the patient, there was never any symptom of suicidal ideation expressed by the patient. There was no reason demonstrated which would justify the referral of the patient to a psychiatrist at an earlier date in the subject situation. The testimony of Dr. Miller and the other experts adduced by the Respondent shows that under the peculiar circumstances of this patient, the use of Adivan, as well as Halcion, in conjunction with the other medications the patient was taking, was medically justified and within the appropriate standard of care. It has been demonstrated that the medical records maintained by the Respondent justify the course of treatment of the patient, as shown by testimony of record at pages 105 and 106 of the transcript of the proceedings and Respondent’s Exhibit 1 at pages 52-54. The Respondent practiced with that level of care, skill and treatment recognized as appropriate to meet the standard of care for similar physicians. Upon weighing the expert testimony adduced by the parties, it is determined that the expert testimony presented by the Respondent was more persuasive and creditable than that presented by the Petitioner. The Petitioner’s expert, Dr. Kreitzer, relied upon some flawed information in developing his expert opinions, including, but not limited to, his reliance upon compilations of prescription information which was not established as accurate in the course of this proceeding, being merely computer printouts from records of pharmacists. Those records do not, for instance, even show that the Respondent prescribed all of those medications represented thereon. Dr. Kreitzer’s opinion was also flawed because his belief was based, in part, on his understanding that the patient was suffering from cardiomyopathy, when that condition had already been ruled out by cardiac tests performed upon the Respondent’s order during the June of 1985 hospitalization. Dr. Kreitzer’s mistaken belief that Fastin is an amphetamine, which it is not, also detracts from the weight which can be ascribed to his opinion. Further, Dr. Groble, the other expert presented by the Petitioner, cannot be relied upon because in his testimony he admits that he cannot render an opinion that the Respondent departed from appropriate standards of care in his practice with regard to the subject patient in the instances alleged in the Administrative Complaint because he had not seen all of the Respondent’s pertinent medical records. Consequently, he could not render a definitive opinion, one way or the other. The Respondent’s expert witnesses, Dr. Miller and Dr. Sharpe, are accepted as more credible than the Petitioner’s expert testimony. Both Drs. Miller and Sharpe indicated that they had reviewed, in some depth, the medical records which the Respondent maintained concerning the patient and those records and the history pertaining to treatment rendered by other physicians and the Center. Their testimony revealed an in-depth study, reflection and consideration of the concededly large doses of multiple medications, some of which have significant side effects. They regrettably agree, that confronted with a complex, life-threatened patient, such as this, the Respondent could have done little else than follow the course of treatment and medication pattern and practice which he followed. While these experts and the Respondent, in the course of treatment, recognized the risks attendant to the engendering of dependency on the steroids and the use of the other medications, they acknowledged that under the circumstances there was little else that could be done in order to keep the patient stable, accord him some quality of life, and even to save his life. In summary, it has not been established that the Respondent failed to adequately keep written medical records which justify the course of treatment of the patient. It has not been established that the Respondent prescribed legend drugs, including controlled substances, other than in the course of his professional practice, nor has it been established that he prescribed legend drugs in excessive quantities and in excessive combinations or, otherwise, inappropriately in relation to generally-accepted medical practice. It has not been established that the Respondent failed to practice medicine with that level of care, skill and treatment recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered by the Board of Medicine dismissing the Administrative Complaint in its entirety.DONE AND ENTERED this 5th day of February, 1997, in Tallahassee, Florida. P. MICHAEL RUFF Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 5th day of February, 1997. COPIES FURNISHED: Albert Peacock, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Bruce D. Lamb, Esquire SHEAR, NEWMAN, ET AL. Post Office Box 2378 Tampa, Florida 33602 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403
Findings Of Fact Respondent, Gregory Burgess Stone, is a licensed practical nurse holding license number 0463451. Respondent was so licensed at all times relevant to this proceeding. Respondent was employed at Orlando Lutheran Towers Health Care Center, 300 East Church Street, Orlando, Florida, as a practical nurse at all times material hereto. During April, 1982, Respondent acted as the full-time medicine nurse on the 7:00 a.m. through 3:00 p.m. nursing shift at Orlando Lutheran Towers. Orlando Lutheran Towers utilizes the Unidose system of medication administration. The individual who administers the medication is required only to remove the appropriate dosage from the Unidose card which may contain from thirty to sixty doses of medication and thereafter record the administration of the medication on a medication administration record by inserting his initials under the appropriate date on the medication administration record format. Each patient at Orlando Lutheran Towers is assigned a Unidose card for each medication he may require. The patient's name and other pertinent information appear on a label placed on the front of the Unidose card. Respondent was intermittently relieved from duty in April by Gloria Underhill, another nurse-employee of Orlando Lutheran Towers. Underhill worked in place of Respondent on April 8, and the Respondent thereafter worked the intervening period from April 9 through April 12. Underhill returned to work in place of Respondent again on April 13, and in the course of administering medications, she observed that certain prescribed medications had not been administered between April 9 and April 13. Underhill ascertained this information because of the procedure she had previously followed. It was Underhill's general practice to place her initials not only on the medication administration record but also on the Unidose card next to the particular unit of medication she intended to administer. By comparing her initials with the physical presence of the succeeding units of medication in the Unidose card, she determined that the Respondent had apparently failed to administer medication to the following patients: PATIENT MEDICATION UNITS NOT RECEIVED 1. Lowe DDS 100 milligrams 4 2. Doze Corgard 40 milligrams 4 3. Miller TAM/LL 3 The medication administration record, however, indicated by the placement of the Respondent's initials that the foregoing medications had been received. Respondent speculated that he may have administered the medication by utilizing doses not taken by other patients. This possibility was not supported by the evidence and is rejected. Underhill's findings were given to the Director of Nursing and the Administrator of Orlando Lutheran Towers, who thereafter confronted Respondent with the Unidose card discrepancies. Respondent did not offer any explanation for the discrepancies and was therefore discharged from employment at Orlando Lutheran Towers.
Recommendation Based on the foregoing, it is RECOMMENDED: That Petitioner enter a final order finding Respondent guilty of the violations of law charged in the Administrative Complaint and placing his license in a probationary status for two years. DONE and ORDERED this 18th day of March, 1983, 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 18th day of March, 1983. COPIES FURNISHED: W. Douglas Moody, Esquire 119 North Monroe Street Tallahassee, Florida 32301 James M. Nicholas, Esquire 170 East Washington Street Orlando, Florida 32801 Helen P. Keefe, Executive Director Board of Nursing Department of Professional Regulation Room 504, 111 East Coastline Drive Jacksonville, Florida 32202 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
