STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF PROFESSIONAL ) REGULATION, )
)
Petitioner, )
)
vs. ) CASE NO. 86-1079
) MICHAEL J. WARHOLA, D.O., )
)
Respondent. )
)
RECOMMENDED ORDER
For Petitioner: Stephanie A. Daniel, Esquire
Tallahassee, Florida
For Respondent: Gerald W. Nelson, Esquire and
Diana K. Wallace, Esquire Tampa, Florida
The issue in this case is whether the Florida Board of Osteopathic Medical Examiners should discipline Respondent, Michael J. Warhola, D.O. (Warhola), for the conduct alleged in the Administrative Complaint filed against him by Petitioner, Department of Professional Regulation. The Administrative Complaint alleges, in nine separate counts, three violations in connection with the treatment of each of three different patients. The three violations are: (1) violation of Section 459.015(1)(q), Florida' Statutes, by prescribing, dispensing, administering, mixing or otherwise preparing a legend drug inappropriately or in excessive or inappropriate quantities not in the best interest of the patients and not in the course of the osteopathic physician's professional practice; (2) violation of Section 459.015(1)(n), Florida Statutes, by failing to keep written medical records justifying the course of treatment of the patient; and (3) violation of Section 459.015(1)(t), Florida Statutes, by failing to practice osteopathic medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar osteopathic physician as, being acceptable under similar conditions and circumstances. 1/ In addition, as to one of the patients, Curtis Hancock, the Administrative Complaint alleges a violation of Section 459.051(1)(t), Florida Statutes, by gross or repeated malpractice. 2/
A formal administrative hearing was held on the issues raised in the Administrative Complaint in Tampa, on October 9 through 10 and December 30 through 31, 1986. One of the parties ordered a transcript of the final hearing. The parties requested and received 10 days after the filing of the transcript in which to file proposed recommended orders. The transcript was filed on February 2, 1987, making the proposed recommended orders due by February 12, 1987.
In addition to live testimony at the final hearing, Petitioner introduced into evidence Petitioner's Exhibits 1 through 19, and Respondent introduced into evidence Respondent's Exhibits 1 through 5. All of the exhibits were received in evidence.
FINDINGS OF FACT
At all times material, Respondent, Michael J. Warhola, D.O. (Warhola), was licensed as an osteopathic physician, license number 05 0001256, issued by the State of Florida.
At all times material, Warhola was in general practice in Tampa, Florida. A large part of Respondent's practice consisted of patients wishing to lose or control weight.
PATIENT CURTIS HANCOCK
Between on or about September 25, 1984 and on or about June 10, 1985, Respondent treated patient Curtis Hancock for weight control primarily. On the first visit, a patient history was obtained from Hancock. The patient history was adequate for a weight control patient such as Hancock except that it did not include a detailed record as to the length of time Hancock has experienced the weight problem, what diet medications Hancock had taken, what kind of weight loss program Hancock had been involved in and the history of recent weight loss or gain and diet.
On Hancock's first visit, Warhola also had Hancock's blood pressure, weight and pulse taken. Additionally, Hancock's age and height were recorded. Respondent did not listen to (auscultate) Hancock's heart sounds but did, and reviewed, an electrocardiogram. These physical examinations and other testing performed on Hancock on the first visit were inadequate for a patient such as Hancock only in that Warhola did not examine and palpate Hancock's neck (for thyroid abnormalities).
One of the tests Warhola had performed on Hancock on September 25, 1984, was a SMAC 26 comprehensive blood test which includes T3, T4 and T7 studies. Those test results and the rest of the examination revealed no abnormalities in Hancock's thyroid function or metabolic function.
On or about the first office visit, Respondent provided Hancock with literature about diet. The literature contained a recommendation that the patient abstain from alcohol and sugar intake. But Respondent did not attempt to treat Hancock by diet and exercise alone first. Respondent generally makes the presumption that by the time a patient comes to him for weight control the patient has tried an assortment of diet regimens, possibly supplemented by exercise and over-the-counter diet medications. He presumes that what the patient wants and needs in order to accomplish weight loss or weight control is prescription diet drugs.
On the first visit on September 25, 1984, Warhola prescribed and dispensed to Hancock the following drugs:
DRUG | QUANTITY |
Multi Vitamin | 28 |
Phentermine 8 mg. | 56 |
Phendimetrazine 35 mg. | 56 |
Promethazine HCL 12.5 mg. | 28 |
On each subsequent office visit Warhola had his office staff take Hancock's blood pressure, weight and pulse rate. At no time during his treatment of Hancock did Respondent listen to Hancock's heart sounds. No additional electrocardiograms of Hancock were taken after the initial visit. Respondent performed no other physical examination of Hancock on any of the subsequent office visits.
Between October 23, 1984 and June 10, 1985, Respondent prescribed and dispensed for Hancock the following drugs:
DATE MEDICATION QUANTITY
10/23/84 Multi Vitamin 28
Thyroid 1 gr. 28
Ferrous Gluconate 28
Phentermine 30 mg. 112
Phendimetrazine 35 mg. 112
Prcmetharine HCL 12.5 mg. 28
11/20/84 Multi Vitamin 28
Thyroid 1 gr. 28
Ferrous Gluconate 28
Phentermine 30 mg. 112
Phendimetrazine 35 mg. 112
Phentermine 8 mg. 112
Promethazine HCL 12.5 mg. 28
12/11/84 | Thyroid 1 gr. | 28 | |
Ferrcus Gluconate | 28 | ||
Phentermine 30 mg. | 112 | ||
Phendimetrazine 35 mg. | 112 | ||
Promethazine HCL 12.5 Bran Fiber | mg. | 28 | |
01/24/85 | Multi Vitamin | 28 | |
Levo Thyroid 0.1 | mg. | 28 | |
Ferrcus Gluconate | 28 | ||
Phentermine 30 mg. | 112 | ||
Phendimetrazine 35 mg. | 112 | ||
Promethazine HCL 12.5 mg. | 28 | ||
Fastamine | 112 | ||
02/01/85 | Multi Vitamin | 28 | |
Levo Thyroid 0.1 mg. | 28 | ||
Ferrous Gluconate | 28 | ||
Phentermine 30 mg. | 112 | ||
Phendimetrazine 35 mg. | 112 | ||
Promethazine HCL 12.5 mg. | 28 | ||
Fastamine | 112 | ||
Vistaril 50 mg. | 28 | ||
03/14/85 | Multi Vitamin | 56 | |
Levo Thyroid 0.1 mg. | 56 | ||
Ferrous Gluconate | 56 | ||
Phentermine 30 mg. | 224 | ||
Phendimetrazine 35 mg. | 224 | ||
Promethazine HCL 12.5 mg. 56
Vistaril 50 mg. 56
Hyosophen - 224
(Belladonna Alkaloids w/ Phenobarbital)
Hydrochlorothiazide 50 mg. 56
w/Reserpine 0.25 mg.
04/30/85 Multi Vitamin 56
Levo Thyroid 0.1 mg. 56
Ferrous Gluconate 56
Phentermine 30 mg. 224
Phendimetrazine 35 mg. 224
Promethazine HCL 12.5 mg. 56
Vistaril 50 mg. 56
Hyosophen 224
(Belladonna Alkaloids w/ Phenobarbital)
Hydrochlorothiazide 50 mg. 56
w/ Reserpine 0.25 mg.
06/10/85 Multi Vitamin 56
Levo Thyroid 0.1 mg. 56
Ferrous Gluconate 56
Phentermine 30 mg. 224
Phendimetrazine 35 mg. 224
Promethazine HCL 12.5 mg. 56
Vistaril 50 mg. 56
Hyosophen 224
(Belladonna Alkaloids w/ Phenobarbital)
Hydrochlorothiazide 50 mg. 56
w/ Reserpine 0.25 mg.
The labels for the drugs identified in the immediately preceding paragraph did not contain the name of the drugs dispensed. Hancock did not ask, and Respondent did not verbally advise Hancock of, the names of the drugs which Respondent dispensed or caused to be dispensed to Hancock.
Phentermine 8 mg. and 30 mg. and phendimetrazine 35 mg. are sympathomimetic amines. Phendimetrazine is a schedule III controlled substance, under Section 893.03, Florida Statutes. Phentermine is a schedule IV controlled substance, under Section 893.03, Florida Statutes. Tolerance to the anorectic affects of both of these drugs usually develops within a few weeks. When this occurs, the recommended dose usually should not be exceeded in an attempt to increase the effect; rather, the drugs should be discontinued. One of the notable contra-indications of both of these drugs is elevated blood pressure (moderate and severe hypertension, any diastolic value of 100 or higher). Manifestations of chronic intoxication with anorectic drugs (like phentermine and phendimetrazine) include marked insomnia, irritability, hyperactivity and personality changes.
Promethazine HCL is a sleep medication.
Thyroid and Levo Thyroid are both thyroid medications which are indicated for use where hypothyroidism exists. Both drugs are metabolic stimulants given to compensate for decreased thyroid function. If either of
these medications is administered to an individual who had a normal thyroid function or euthyroidism, the drugs would cause the individual to experience hyperthyroidism, or an increased metabolic condition, and the possibility of serious side effects.
Fastamine is the brand name for a drug containing benzocaine and is used to curb appetite by numbing the stomach.
Vistaril is a depressant which can function as an anti-anxiety agent.
Hydrochlorothiazide 50 mg. is a diuretic which was dispensed by Respondent in a compound form which also contained Reserpine 0.25 mg. Reserpine is a drug that will cause an initial stimulation, like epinephrine, followed by a secondary effect of depression. Hydrocholorthiazide 50 mg. with reserpine
0.25 mg. is used as a diuretic and an anti-hypertensive agent.
It is generally accepted that thyroid medications, such as Thyroid, Levo Thyroid and a drug named Cytomel (which is similar in action to the other thyroid medications), should not be prescribed, dispensed, or ordered with sympathomimetic amines. The combination of thyroid medications and sympathomimetic amines, when dispensed or prescribed to be taken together, can be very dangerous and can potentially result in cardiovascular shock. Unless caused by hypothyroidism, obesity is not an acceptable indication for thyroid hormone therapy.
A review of Respondent's records for patient Hancock reveals that between September 25 and December 11, 1984, Hancock lost 12 1/2 pounds. Between January 24 and February 1, 1985, Hancock gained 4 1/2 pounds. Between February
1 and April 30, 1985, Hancock lost 11 1/2 pounds. Between April 30 and June 10, 1985, Hancock gained 6 1/2 pounds. Respondent's records reflect Hancock's starting weight was 213 1/2 pounds. On the date of Hancock's last visit, almost ten months after the patient's first visit, Hancock weighed 200 1/2 pounds with a total weight loss of only 13 pounds.
A review of Respondent's records for patient Hancock reveals that Hancock's blood pressure was 120/84 on September 25, 1984; 120/84 on October 23, 1984; 122/80 on November 20, 1984; 120/84 on December 11, 1984; 130/90 on January 24, 1985; 140/100 on February 21, 1985; 150/100 on March 14, 1985; 144/90 on April 30, 1985; and 130/80 on June 10', 1985. In an otherwise healthy adult, any diastolic (the second of the two numbers in a blood pressure reading) value of 90 or greater for an extended period of time is considered mild hypertension. A diastolic value of 100 or greater is considered serious hypertension.
Despite the fact that the diastolic value of Hancock's blood pressure readings was 90 or higher between January 24, 1985 and April 30, 1985, Respondent did not reduce or eliminate the number of sympathomimetic amines and thyroid medications dispensed to patient Hancock. Respondent responded to the elevated blood pressure readings found in Hancock by adding an anti-hypertensive agent to the existing regimen of drugs. He hypothesized that the elevated blood pressure was a result of marital problems Hancock told him he was having.
On March 14, 1985, April 30, 1985, and June 10, 1985, Respondent dispensed what was supposed to be a two months supply of the above-listed drugs. On April 30, 1985, Hancock returned for more medications after 46 days; and on June 10, 1985, Hancock returned for medications after only 40 days.
Nonetheless, Respondent dispensed more medications on each occasion.
Respondent's records indicate that on April 30, 1985, a two month supply was dispensed because the Respondent was going on vacation.
Respondent told Ms. Gazverde during the course of an interview that if a patient returned earlier than scheduled, refills would be refused until the scheduled visit or proof of loss of medication was provided. But, if this was Respondent's policy, it was not followed in Hancock's case.
Respondent inappropriately and excessively dispensed phentermine, phendimetrazine and thyroid medications, including Thyroid and Levo Thyroid, to patient Hancock in that:
The phentermine and phendimetrazine were prescribed and dispensed in excessive dosages and for an excessive length of time;
The phentermine and phendimetrazine were prescribed and dispensed in combination (and in excessive dosages);
Thyroid medications were prescribed although Hancock's thyroid was normal;
Thyroid medications were prescribed to be taken in combination with the phentermine and phendimetrazine;
Respondent continued to prescribe phentermine, phendimetrozi and thyroid medications to Hancock despite moderate to severe hypertension (140/100 on 2/21/85 and 150/100 on 3/14/85);
Respondent twice dispensed more drugs than he had prescribed for Hancock without
requiring Hancock to account for the missing drugs; and
Respondent made no effort to treat Hancock without drugs as first line of treatment.
Respondent failed to practice osteopathic medicine with acceptable levels of care, skill and treatment for the reasons listed in paragraph 23, above, and because Respondent did not examine or palpate Hancock's neck for thyroid abnormalities on any visit and neither did an electrocardiogram nor listened to Hancock's heart sounds on follow-up visits.
In addition to the matters set out in the two immediately preceding paragraphs, Respondent's records for patient Hancock were not adequate to justify Respondent's treatment of Hancock in that no information was recorded as to the length of time the patient had experienced a weight problem; what diet medications Hancock had taken; what kind of weight loss program Hancock had been involved in; and a history of recent weight loss or gain and diet.
A reasonably prudent osteopathic physician, in obtaining a patient history for weight control purposes, would question the patient as to their normal weight, determine past techniques utilized for weight control (including medication, diet and exercise), and ascertain recent weight history and length of time the weight problem has existed. The information should be in the patient record.
Additionally, a reasonably prudent physician, in examining a patient for weight control purposes, would perform a physical examination including, at
a minimum, examination and palpation of the neck and auscultation of the heart. Alternatively, an electrocardiogram serves the purpose of auscultation of the heart.
Respondent did not examine or palpate patient Hancock's neck. Furthermore, Respondent did not listen to patient Hancock's heart sounds. Respondent did and reviewed an electrocardiogram on Hancock's first visit but not on his follow-up visits.
PATIENT HOPE ECHEZABAL
Between on or about November 3, 1971 and April 21, 1984, Warhola intermittently treated patient Hope Echezabal for weight control. On Echezabal's first visit, Warhola took an adequate patient history of Echezabal except, like Hancock, the patient history does not record detailed information as to the length of time the patient had experienced a weight problem, what diet medications Echezabal had taken, what kind of weight loss program Echezabal had been involved in, or a history of recent weight loss or gain and diet. The patient history indicated normal menstruation.
On Echezabal's first visit to Respondent's office, Respondent performed an inadequate physical examination only in that no pulse rate was taken and Warhola did not examine or palpate the patient's neck. Respondent also did not listen to Echezabal's heart sounds, but Warhola did have an electrocardiogram done on Echezabal.
The testing did include testing with an achilleometer, an obsolete thyroid test. All of the testing and physical examination of Echezabal revealed no thyroid or metabolic abnormalities.
Like Hancock after her, Echezabal was given diet literature, including a booklet called "Lo-Carbo Diet," and was advised to avoid starches, sugar, and alcoholic beverages. Respondent also discussed Echezabal's diet and eating habits.
Echezabal returned to Respondent's office on December 3, 1971, January 12, 1972 and April 7, 1972. As was his practice on follow-up visits, Warhola had his office staff weigh Echezabal and take her blood pressure. Although no additional electrocardiogram was performed, Warhola did not take Echezabal's pulse rate or listen to her heart sounds. In fact, he did no further physical examination of Echezabal at all. He just discussed diet and whether Echezabal was following her diet.
After a hiatus of two years, Echezabal went back to Respondent on or about August 20, 1973. In accordance with his practice, Warhola treated Echezabal as he would a new patient since she had not been to his office for over a year. Warhola had Echezabal update her patient history in the same manner in which he did her original patient history. His physical examination and testing also was the same as on the initial visit in 1971. Once again, the examination and testing revealed no thyroid or metabolic abnormalities. Warhola also discussed with the patient her diet and eating habits.
Echezabal returned to Respondent's office on November 16, 1973. On this follow-up visit, Warhola had his office staff take Echezabal's blood pressure and weigh her. Otherwise, Warhola did not physically examine
Echezabal. Her pulse rate was not taken, there was no additional electrocardiogram, and Respondent did not listen to her heart. Warhola did, however, again discuss Echezabal's diet and eating habits.
It is clear from Echezabal's testimony that Respondent's treatment of her before May, 1979, included the use of medications. Echezabal did not ask, and was never advised either verbally or by labeling, of the names of the drugs which were dispensed to her by Respondent. As with all his patients, Respondent documented the drugs dispensed to Echezabal by utilizing medication codes instead of the common name for the drugs. The medication codes were then recorded in the patient charts. Because the medication codes have changed over the years, the identities of the drugs dispensed to Echezabal before May, 1979, are unknown.
Echezabal did not return to Respondent's office again until May 29, 1979. Because it had been about 5 1/2 years since Echezabal's last visit, Respondent treated her as a new patient, requiring the same updates to her patient history and having the same examinations and tests performed, including an electrocardiogram. Testing indicated that Echezabal was marginally anemic, and Respondent prescribed and dispensed iron tablets only and told her to return for a follow-up visit. Otherwise, the examination and testing revealed no abnormalities.
Echezabal returned for a follow-up visit on June 11, 1979. On that date, Warhola had his office staff take Echezabal's blood pressure and weigh her. Additionally, office staff obtained a hemoglobin and hematocrit count on Echezabal and drew blood for analysis at an outside laboratory. Warhola did not take Echezabal's pulse rate or do another electrocardiogram or listen to her heart sounds. Warhola did no other physical examination of Respondent on June 11, 1979, but only discussed diet and eating habits.
On or about June 11, 1979, Respondent dispensed to Echezabal 28 ferrous sulfate 5 gr. tablets, 28 Thyroid 2 gr. tablets, 112 phendimetrazine 35 mg. tablets, 28 Benadryl 50 mg. tablets, and 28 multi vitamin/mineral tablets, with instructions to begin taking the pills on the next day. When Respondent dispensed the above-mentioned drugs on June 11, 1979, Respondent did not have the results of tests which were to be performed by an outside laboratory on blood drawn by office staff. (Respondent had ordered a SMA 15 profile, which includes testing for glucose levels, and a thyroid study done on the blood specimen.) However, Respondent would have contacted patient Echezabal when the results came back the next day if he thought the results contra-indicated any of the medications.
On or about June 12, 1979, Respondent received the results of a thyroid study and SMA 15 profile at Patterson Coleman Laboratories. The tests revealed no metabolic abnormalities. The test did reveal a slight abnormality in the T3 value, which was "34". The T3 value measures thyroid uptake and was only marginally below normal limits. In determining whether there is abnormal thyroid function, the "T3" value is only one factor to be considered. In view of the fact that the two other pertinent values, the thyroxine, or T4 value, and the "FTI" value were within normal limits, Echezabal could not properly have been diagnosed as suffering from abnormal thyroid function. Furthermore, it would be inappropriate to prescribe thyroid medication, given the results of the thyroid study done in June 1979.
Respondent's records for Echezabal do not document any history of an abnormal thyroid function or any history involving thyroid medications taken by Echezabal prior to 1971.
Despite the fact that patient Echezabal revealed no conclusive evidence of an abnormal thyroid function, Respondent failed to discontinue the thyroid medication which he ordered for Echezabal on June 11, 1979.
On or about August 2, 1983, Echezabal returned to Respondent's office and was, again, treated like a new patient. Accordingly, Echezabal was asked to update her patient history. Additionally, office staff took Echezabal's blood pressure and pulse, and weighed Echezabal. This was the first occasion on which Echezabal's pulse rate was taken. On August 2, 1983, office staff obtained a hemoglobin and hematocrit count, performed a urinalysis and performed an electrocardiogram on Echezabal. Additionally, office staff drew blood for analysis by an outside laboratory. Finally, Warhola again discussed diet and eating habits with Echezabal.
On or about August 2, 1983, Respondent dispensed or caused office staff to dispense to Hope Echezabal Cytomel 50 mg. (which is a thyroid medication similar to Thyroid and Levo Thyroid discussed above), phendimetrazine
35 mg., ferrous sulfate 5 gr. (iron), and Benadryl 50 mg., an antihistamine. Again, Respondent dispensed these medications without waiting for the results of SMA 26 profile which was to be performed on the blood specimen drawn by office staff at outside laboratories.
On or about August 3, 1983, Respondent received the results of the SMA
26 which was performed at Central Medical Laboratory, Inc., which included an analysis of thyroid function. The tests revealed completely normal thyroid function. Despite evidence of normal thyroid function, Respondent failed to discontinue the Cytomel 50 mg. which he had prescribed for Echezabal.
On or about September 8, 1983, Echezabal returned to Respondent's office. On that date, office staff took Echezabal's blood pressure and pulse. Additionally, office staff weighed Echezabal. Finally, as was his practice, Respondent spoke to Echezabal about her diet and eating habits. Respondent failed to conduct any kind of examination of Echezabal on September 8, 1983. Nor did Warhola do another electrocardiogram.
On or about September 8, 1983, Respondent caused office staff to dispense 28 Cytomel 50 mg. tablets, 112 phendimetrazine 35 mg. tablets, 28 Benadryl 50 mg. tablets and 28 multi vitamin/mineral tablets to patient Echezabal. At the time Respondent caused these medications to be dispensed, his records reflected normal thyroid function in Echezabal.
On or about April 21, 1984, Echezabal again came to Respondent's office for weight control purposes. On that date, office staff obtained an update in patient history, and obtained the patient's blood pressure, pulse, and weight. Also on that date, office staff obtained hematocrit and hemoglobin levels for the patient, a two hour post prandial blood sugar, and a urinalysis. Echezabal's blood pressure was 130/90 on April 21, 1984.
Respondent spoke with Echezabal about her diet and eating habits. Respondent did not examine patient Echezabal at all on April 21, 1984. Nor did Warhola do another electrocardiogram.
On or about April 21, 1984, Respondent caused office staff to dispense
28 Hydroreserpine .25 mg. tablets, 28 Levo Thyroid .1 mg. tablets, 56 phentermine 30 mg. tablets, 28 Benadryl 50 mg. tablets, and 28 multi vitamin/mineral tablets to Echezabal with instructions to start taking the pills the next day. At the time Respondent dispensed the above-mentioned drugs, his own records for patient Echezabal revealed normal thyroid function.
Hydroreserpine is the brand name for a compound containing a diuretic and reserpine (which has previously been described above). Hydroreserpine is typically given as an anit-hypertensive agent.
On or about April 22, 1984, Echezabal began to take the medications dispensed by Respondent on April 21, 1984, in the manner directed by Respondent. Accordingly, Echezabal would have taken 4 tablets by noon on that date. Echezabal should have taken by 10:00 a.m., on April 22, 1984, a green Hydroreserpine .25 mg. tablet (probably before breakfast), a yellow phentermine
30 mg. tablet (probably before breakfast), a yellow Levo Thyroid .1 mg. tablet (probably at 10:00 a.m.) and a white phentermine 30 mg. tablet (at 10:00 am.). After taking her 10:00 a.m. medication, Echezabal experienced a reaction to the medication. Specifically, Echezabal vomited and was hyperventilating. Echezabal rested for a period of time and was later transported to University Community Hospital in Tampa, Florida, by ambulance, where she was treated for a drug overdose.
At no time during his treatment of patient Echezabal did Echezabal ask, or did Respondent advise Echezabal of, the names of the drugs which were dispensed by his office staff to Echezabal. Furthermore, the labeling for the substances dispensed to Echezabal did not contain the name of the medications dispensed. When Echezabal arrived at University Community Hospital, neither Echezabal nor her husband, Henry, who drove her to the hospital, knew what drugs Mrs. Echezabal had taken on the morning of April 22, 1984.
At the time of admission at University Community Hospital, blood and urine specimens were taken from Echezabal for analysis. A comprehensive drug profile showed no alcohol. A second test performed on gastric blood serum revealed ethanol in the blood serum in the amount of 0.016 GM percent. The amount would be relatively negligible.
Respondent inappropriately dispensed medications to patient Echezabal in that:
Thyroid medications were prescribed although Echezabal's thyroid was normal;
Sympathomimetic amine was prescribed
to be taken in combination with thyroid medication;
Phentermine was prescribed on April 21, 1984, in excess of maximum dosages; and
Respondent made no effort to treat Echezabal without drugs as a first line of treatment (especially when she lost a pound between May 28 and June 11, 1979, without any medication prescription.)
Respondent failed to practice osteopathic medicine with acceptable levels of care, skill and treatment for the reasons listed in paragraph 55, above, and because Respondent did not examine or palpate Echezabal's neck for thyroid abnormalities on any visit, neither did an electrocardiogram nor
listened to her heart sounds on follow-up visits or on April 21, 1984, and did not take her pulse on some visits.
In addition to the matters set out in paragraphs 55 and 56, above, Respondent's records for patient Echezabal were not adequate to justify Respondent's treatment in that:
The records do not detail weight control programs the patient had tried, diet medications taken or recent history of weight loss or gain and diet;
The records do not justify starting Echezabal at relatively high dosages of phendimetrazine on June 11, 1979 and August 2, 1983;
The records do not justify the Benadryl prescriptions; and;
The records do not state whether the patient was on a diet or explain why she lost a pound between May 28 and June 11, 1979, without any medication prescription.
PATIENT BETH HELLE
Between on or about November 8, 1971, and on or about May 4, 1984, Respondent intermittently treated Beth Helle for weight control. On Helle's first visit, Warhola required a patient history which was adequate except it but did not detail the length of time the patient had experienced a weight problem, what diet medications she had taken, what kind of weight loss program she had been involved in or a history of the recent weight loss or gain and diet. It indicated a normal menstrual history. Warhola also performed an inadequate physical examination only in that Warhola did not take Helle's pulse or examine or palpate her neck for thyroid abnormality. He did not listen to her heart sounds, but he took Helle's cardiogram. Warhola also discussed diet with Helle. He told her what foods she could eat and gave her a book dealing with carbohydrate counts in different foods designed to assist the patient in limiting carbohydrate intake.
The examination and testing of Helle on November 8, 1971, which included testing with an achilleometer, did not reveal any abnormal thyroid or metabolic function. Helle's patient history revealed hypertension in 1970, but that condition probably related to a pregnancy and miscarriage at that time.
On or about November 8, 1971, Respondent caused office staff to dispense medications to Helle. Helle never asked, and Respondent never told Helle, what the medication were. The labels on medication dispensed to Helle (like Echezabal) did not contain the common name of the drug dispensed. In Respondent's records, the medication names are indicated in a code, which has since changed. The names of the medications dispensed by Respondent to Helle before 1984 are unknown.
On or about May 12, 1975, Helle returned to Respondent's office for treatment. Since 3 1/2 years had passed, Helle was treated as a new patient. Helle's patient history was updated in the same manner as the original patient history. Again Warhola inadequately examined Helle only in that Helle's pulse rate was not taken, and Respondent did not examine and palpate Helle's neck. Warhola did not listen to her heart sounds, but he did perform an electrocardiogram of Helle among the tests he performed. Again, the examination
and tests, which included testing with an achilleometer, revealed no abnormal thyroid or metabolic function.
In addition to the examination and testing on May 12, 1975, Warhola again discussed diet with Helle. He had his office staff dispense medications to Helle. Helle did not ask, and Respondent did not verbally advise Helle of, the names of the drugs dispensed. Again, the labels were in code, and identities of the drugs are not now known.
On or about June 16, 1975, Helle returned to Respondent's office. On this follow-up visit, Warhola had his office staff take and record Helle's blood pressure and weight. Her pulse was not taken, and no electrocardiogram was made. Warhola did not physically examine Helle and specifically did not listen to her heart sounds or examine or palpate her neck. Warhola again discussed eating habits and diet with Helle and had his office staff dispense medications. Again, Helle did not ask, and was not told, what the medications were, and the medication labeling did not reflect the drug name. The code on the label has been changed, and the identities of the drugs are not now known.
Helle returned for another follow-up visit on October 30, 1975. Again, Warhola had his office staff take and record Helle's blood pressure and weight. Her pulse rate was not taken, and no electrocardiogram was made. Warhola did no physical examination and specifically did not listen to Helle's heart sounds or examine or palpate her neck. Respondent again discussed diet and eating habits with Helle.
Helle did not return to Warhola's office for treatment until May 4, 1984. Since eight and 1/2 years had elapsed since her last visit, Helle was treated as a new patient the same type of update of her patient history was taken. Warhola also had his office staff take and record Helle's blood pressure, pulse and weight. Blood specimens for analysis at an outside laboratory also were drawn. Warhola did not listen to Helle's heart sounds but did make and review an electrocardiogram. He did not examine or palpate her neck. Finally, Respondent talked with Helle about her diet and eating habits, specifically advising her to avoid fatty foods.
On or about May 4, 1984, Respondent caused office staff to dispense 28 trichloromethiazide 4-mg. tablets, 28 Levo Thyroid .1 mg. tablets, 112 phendimetrazine 35 mg. tablets, 112 phentermine 8 mg. tablets, 28 branfiber tablets, and 28 Benadryl 50 mg. tablets. Respondent dispensed these medications without waiting for the analysis by the outside laboratory of blood drawn from Helle on that date.
Trichloromethiazide is an oral diuretic and anti- hypertensive agent.
On or about May 5, 1984, Respondent received the results of a SMA 26 profile run on the blood specimen obtained from Helle on May 4, 1984. The laboratory results revealed normal thyroid function, normal glucose levels and normal metabolic function. On or about May 8, 1984, Respondent received the results of a TSH profile run on May 4, 1984. The test again revealed normal thyroid function.
Respondent's records for patient Helle do not reveal any documentation of a history of abnormal thyroid function even though Helle testified at the formal hearing that she had experienced abnormal thyroid function previously. Proper documentation would include a description of the abnormality (hypothyroidism or hyperthyroidism); a statement as to how long the condition
existed; and a description of how the condition was treated. This last factor would be most significant in this case because Respondent dispensed Levo Thyroid although Helle testified that she had previous reactions to another thyroid medication (Cytomel).
Respondent's records contain no documentation of any abnormal thyroid function during Respondent's treatment of the patient.
None of the medications dispensed by Respondent's office staff on May 4, 1984, were labeled in a manner which would identify the common name of the drug.
Respondent inappropriately and excessively prescribed phentermine, phendimetrazine and Levo Thyroid to patient Helle, in that:
The phentermine and phendimetrazine were prescribed and dispensed in excessive dosages;
The phentermine and phendimetrazine were prescribed and dispensed on May 4, 1984, in combination (and in excessive dosages);
Thyroid medication was prescribed on
May 4, 1984, although Helle's thyroid was normal, according to information known to Warhola at that time;
Thyroid medication was prescribed to be taken in combination with phentermine and phendime- trazine; and
Respondent made no effort to treat Helle without drugs as a first line of treatment.
Respondent failed to practice osteopathic medicine with acceptable levels of care, skill and treatment for the reasons listed in paragraph 72, above, and because Respondent did not examine or palpate Helle's neck for thyroid abnormalities on any visit, neither did an electrocardiogram nor listened to her heart sounds on two follow-up visits, and did not take her pulse on the first four of her five visits.
In addition to the matters set out in paragraphs 72 and 73, above, Respondent's records for patient Helle were not adequate to justify Respondent's treatment in that:
The records do not detail weight control programs the patient had tried, diet medications taken or recent history of weight gain or loss and diet;
The records do not justify starting Helle at high dosages of phentimetrazine (much less in combination with the other drugs) on May 4, 1984;
The records do not justify the Benadryl prescription; and
the records do not detail what "swelling always" and "some fluid retention" notations mean, including the part of the body affected, the results of examination and Respondent's diagnosis.
CONCLUSIONS OF LAW
Section 459.015(2), Florida Statutes (1985), empowers the Board of Osteopathic Medical Examiners to revoke, suspend or otherwise discipline the license of an osteopathic physician for violating any of the following subsections of Section 459.015(1), Florida Statutes (1985):
(h) Failing to perform any statutory legal obligation placed upon a licensed osteopathic physician.
* * *
(l) Making deceptive, untrue, or fraudulent representations in the practice of osteopathic medicine or employing a trick or scheme in the practice of osteopathic medicine when such scheme or trick fails
to conform to the generally prevailing standards of treatment in the medical community.
* * *
(n) Failing to keep written medical records justifying the course of treatment of the patient, including, but not limited to patient histories, examination results, and test results.
* * *
(q) Prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including all controlled substances, other than in the course of the osteopathic physician's professional practice. For
the purposes of this paragraph, it shall be legally presumed that prescribing,
dispensing, administering, mixing, or otherwise preparing legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the osteopathic physician's professional practice, without regard to his intent.
* * *
(t) Gross or repeated malpractice or the failure to practice osteopathic medicine
with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances.
Counts One, Five and Nine of the Administrative Complaint allege that Respondent violated Section 459.015(1)(q), Florida Statutes (1985), by prescribing outside of the course of his practice. As found, the evidence proved that Respondent inappropriately and excessively prescribed controlled substances and legend drugs to all three patients. Section 459.015(1)(q), Florida Statutes (1985), provides that when a physician prescribes inappropriately or in excessive or inappropriate quantities, it shall be
presumed that the physician was acting outside the course of his professional practice and not in the best interests of the patient. Accordingly, it is concluded that Respondent violated Section 459.015(1)(q), Florida Statutes (1985), as alleged in Counts One, Five and Nine of the Administrative Complaint.
Counts Four, Eight, and Twelve of the Administrative Complaint allege that Respondent violated Section 459.015(1)(t), Florida Statutes (1985), by committing gross or repeated malpractice or failing to practice medicine with acceptable levels of care, skill and treatment. As reflected in the findings, the evidence proved that Respondent violated the latter provision of Section 489.015(1)(t), Florida Statutes (1985), with respect to all three patients. (Gross or repeated malpractice was not proved.) As to each patient, there were aspects of Respondent's care, skill and treatment in addition to the violations of Section 459.015(1)(q) which were below acceptable levels. Therefore, as reflected in the findings, the violations of Section 459.015(1)(t) are not merely duplicative of the violations of Section 459.015(1)(q) but are in addition to them.
Petitioner has taken the position that Respondent also violated Section 459.015(1)(t), Florida Statutes (1985), by failing to label the drugs he prescribed with the name of the drug and failing to tell the patients the name of the drugs. However, the evidence was that Respondent met all drug labeling requirements under the applicable laws.
Section 465.027(2), Florida Statutes (1985), which provides that nothing in Chapter 465, Florida Statutes, shall be construed to prevent a practitioner authorized by law to prescribe medicinal drugs from compounding, dispensing, or giving such drugs to his patients in the regular course of practice. Such compounding and dispensing may be done only by the practitioner himself and shall comply with all state and federal laws relating to the labeling and dispensing of medicinal drugs.
Section 499.07(4), Florida Statutes (1985), does state that a drug is misbranded if its label does not bear the common or usual name of the drug. However, Section 499.07(12)(b), states that a drug is exempt from the requirements of subsection (4), among others, if the drug bears a label containing the name and address of the dispenser or seller, the prescription number and date of such prescription or its filling, the name of the prescriber and the name of the patient, the directions for use and cautionary statements. This section does not require the name of the drug to be placed on the label.
Since Respondent followed the labeling law, it is concluded, as matter of law, that failure to label the drugs by name cannot be a violation of Section 459.018(1)(t). The evidence did not prove that a licensee is required to tell his patients the names of the drugs he prescribes for them if they do not ask (although it-may be the better practice.)
Counts Three, Seven and Eleven of the Administrative Complaint allege that Respondent failed to maintain adequate records to justify his treatment of the three patients, in violation of Section 459.015(1)(n), Florida Statutes (1985). This statutory subsection imposes a twofold requirement on osteopathic physicians. First, osteopathic physicians must maintain patient records including records of histories, physical examinations and laboratory testing. Furthermore, the statute requires the physician to keep such records as justify his treatment of the patient. As found, Respondent's patient records for all three patients were inadequate in some respects and did not justify all of the
treatments given to the patients. Accordingly, the evidence proved violations of Section 459.015(1)(n), Florida Statutes (1985).
As reflected in the findings, not every treatment not justified by a physician's records is a violation of Section 459.015(n). Where the treatment is not justified because it violates Section 459.015(q) or (t), it necessarily would not be justified by the records (unless the records were falsified.) Therefore, a Section 459.015(1)(n) violation is in the nature of a lesser included violation under Section.459.015(1)(q) and (t). A licensee guilty of the higher offense should not also be held guilty of the lesser included Section 459.015(1)(n) violation. Cf. 15 FLA. JUR. 2d Criminal Law ss 887-888 (1979).
Based on the foregoing Findings Of Fact and Conclusions Of Law, it is recommended that the Board of Osteopathic Medical Examiners enter a final order holding Respondent, Michael J. Warhola, D.O., guilty of violating Sections 459.015(n),(q) and (t), Florida Statutes (1985), and suspending his license to practice osteopathic medicine for six months.
RECOMMENDED this 4th day of March, 1987 in Tallahassee, Florida.
J. LAWRENCE JOHNSTON Hearing Officer
Division of Administrative Hearings The Oakland Building
2009 Apalachee Parkway
Tallahassee, Florida 32399-1550
(904) 488-9675
Filed with the Clerk of the Division of Administrative Hearings this 4th day of March, 1987.
ENDNOTES
1/ An additional allegation of a violation of Section 459.015(1)(h), Florida Statutes, by failing to perform the Statutory or legal obligation placed upon a licensed physician by Section 893.05, Florida Statutes, that a practitioner, in good faith and in the course of his professional practice only, may prescribe, administer, dispense, mix or otherwise prepare a controlled substance, was alleged in the Administrative Complaint but dismissed during the formal administrative hearing.
2/ The Administrative Complaint includes identical allegations as to the other two patients, but the allegations as to the other two patients were dismissed during the formal administrative hearing. The Administrative Complaint also contains three separate counts, each alleging as to one of the three patients a violation of Section 459.015(1)(h), Florida Statutes, by failing to perform the statutory or legal obligation placed upon a licensed osteopathic physician by Section 465.027(2), Florida Statutes, to comply with all federal and state laws relating to the labeling and dispensing of medicinal drugs. But these allegations were dismissed voluntarily in Petitioner's Proposed Recommended Order. Finally, in addition to the twelve separate counts relating to the
treatment of the three patients, the Administrative Complaint includes a Count Thirteen, which alleges that Respondent violated Section 459.015(1)(1), Florida Statutes, by employing a trick or scheme in the practice of osteopathic medicine when such scheme or trick fails to conform with the generally prevailing standards of treatment in the medical community. But this count also was dismissed voluntarily in Petitioner's Proposed Recommended Order.
APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-1079
These rulings on the parties' proposed findings of fact are made in compliance with Section 120.59(2), Florida Statutes (1985).
Petitioner's Proposed Findings Of Fact.
1.-2. Accepted and incorporated.
First two sentences, accepted and incorporated; rest accepted but unnecessary.
Accepted and incorporated except "lung sounds," which are irrelevant and unnecessary for a weight control patient and therefore an unnecessary finding of fact. In addition, the proposed finding omits reference to the electrocardiogram, which is an acceptable substitute for auscultation of the heart.
5.-6. Accepted and incorporated except, as to "lung sounds" in 6., see paragraph 4, above.
Accepted and incorporated except- it omits that the patient did not ask for drug identification.
Accepted and incorporated except the last sentence which is subordinate to facts found.
9.-14. Accepted and incorporated except, as to 14.,
there may be circumstances not present in this case which could justify use of thyroid medication with sympathomimetic amines, and obesity caused by hypothyroidism could justify use of thyroid medication in part for weight control.
Accepted but unnecessary. Respondent's use of blood pressure medication is not the issue as much as his failure to stop medicating with sympathomimetic amines in the face of moderate and severe hypertension.
Accepted but unnecessary since Respondent used it for hypertension, not as a placebo.
Accepted but in part unnecessary.
18.-22. Accepted and incorporated except, as to 20., the proposed finding omits to mention what Respondent believed was the cause of the hypertension.
Accepted but unnecessary because Hancock's reaction cannot be linked causally to Respondent. He was self-medicating, using illegal drugs and drinking at the same time he was using Respondent's
prescriptions, all of which Respondent did not know or have reason to know.
Accepted and incorporated, along with other findings, in part; in part, rejected as covered by other violations. See Conclusion Of Law 6.
Accepted and incorporated.
26.-27. Accepted and incorporated except: it omits that
an electrocardiogram serves as an acceptable substitute for auscultation of the heart; an examination and palpation of the abdomen is not necessary for a weight control patient; and auscultation of the lungs is not necessary for a weight control patient.
28. Accepted but unnecessary.
29.-30. Covered by Findings Of Fact 23 and 24. See also Conclusion Of Law 3.
31.-32. Accepted but unnecessary.
Unnecessary.
Accepted and incorporated to the extent necessary.
Accepted and incorporated to the extent necessary. See paragraphs 4 and 26.-27, above.
Accepted and incorporated to the extent necessary.
Accepted and incorporated.
Accepted and incorporated to the extent necessary.
Accepted but unnecessary. Without findings as to the drugs prescribed in these earlier years, Echezabal's pattern of weight gain and loss cannot support any relevant findings.
40.-41. Accepted and incorporated to the extent necessary; rejected, to the extent it implies Respondent did not consult and review the results of the tests, as not proved. Also, it omits reference to the electrocardiogram.
42.-46. Accepted and incorporated to the extent necessary.
However, they omit that the patient never asked for the identities of the drugs prescribed.
47.-52. Accepted and incorporated, with findings added to 49. 53.-64. Accepted and incorporated. (As to 64, see paragraphs
42-46, above.)
Accepted and incorporated to the extent necessary, not cumulative and not subordinate. (Only the alcohol readings are necessary; what Respondent prescribed and Echezabal took is cumulative.)
Covered by Finding Of Fact 57. See also Conclusion Of Law 6.
Covered by Finding Of Fact 55. See also Conclusion Of Law 6.
Covered by Finding Of Fact 56. -See also Conclusion Of Law 3.
Unnecessary.
70.-86. Accepted and incorporated to the extent necessary except (1) it omits that the hypertension in 1970 probably related to a pregnancy and miscarriage and (2), as to 73, 76 and 78, see paragraphs
42-46, above.
Rejected because (1) as to 1970, the records are adequate and (2) as to May 4, 1984, Respondent was not treating hypertension, but medicating as a preventive measure in conjunction with sympathomimetic amines.
Covered by Finding Of Fact 74. See also Conclusion Of Law 6. 88.[sic] Covered by Finding Of Fact 72.
Accepted and incorporated.
Covered by Finding Of Fact 73. See also Conclusion of Law 3.
Respondent's Proposed Findings Of Fact.
Accepted and incorporated.
Accepted but unnecessary.
Rejected. This is supposed to be the theory of anorectic drugs, but the evidence was insufficient to prove Respondent followed the theory in practice. His treatment of Curtis Hancock suggests he did not.
The evidence also suggested that the theory rarely works but use of anorectic drugs apparently still is an approved practice for an osteopathic physician.
Accepted and incorporated. However, not all of the medical community recognizes them as effective, according to the evidence.
Accepted, but only if the obesity is caused at least in part by hypothyroidism and only in the relatively short term. Improper use can result in
serious side effects. Rarely, if ever, should thyroid medication be used with anorectic agents for the primary purpose of weight loss or control.
Rejected as not proved. Most patients, not all, develop tolerance, but in different degrees. Patients must be monitored and treated on an individual basis. For patients who develop tolerances, increased dosage can continue weight loss or prevent weight regain.
But serious side effects and dangers of intoxication, addiction and overdose make long-term therapy unwise in almost all cases.
Accepted and incorporated. Anti-hypertensive drugs can be used in patients with mild hypertension as a precaution in tandem with an anorectic agent.
Rejected as not proved that a "cursory" examination is sufficient. Either an electrocardiogram or auscultation of the heart sounds is necessary on each visit. So is weight, blood pressure and pulse rate.
In addition, the patient's neck should' be examined and palpated for thyroid abnormality.
Accepted and incorporated to the extent necessary, except that pulse rate was not taken each time for the three patients in this case and the
medical histories were not "complete." The history generally does not seem to include detailed history of prior weight loss programs and medications, diets,
goals, weights achieves and the recent weight loss and gain.
Accepted and incorporated.
Accepted but unnecessary.
Accepted and incorporated. 13.-22. Accepted but unnecessary.
Accepted and incorporated.
Last sentence, rejected as contrary to facts found; the balance, accepted and incorporated to the extent necessary.
Rejected because the evidence was that Respondent's treatments were successful for relatively short periods of time when she followed the program, followed by a pattern of regaining the lost weight and more.
Rejected in part as not proved in that Echezabal did not get most of the tests on follow-up visits and did not always get an electrocardiogram, pulse and thyroid screen on initial visits. Examinations were inadequate only in that Respondent generally did not examine or palpate the patient's neck, did not always take her pulse and did not always either do an electrocardiogram or listen to heart sounds.
27.-32. Accepted and incorporated to the extent necessary.
Accepted and incorporated, except the last sentence is rejected because the alcohol revealed was relatively negligible.
Accepted and incorporated.
First sentence, accepted and incorporated; second sentence, unnecessary.
Rejected as subordinate to facts not proved. Also, unnecessary. See paragraph 37, below.
Rejected because it was not proved exactly what caused Echezabal's illness in addition-to the ingestion of some phentermine. It was not proved that the dosage prescribed by Respondent caused the patient's illness.
Accepted but unnecessary.
Rejected as contrary to facts found.
Accepted and incorporated.
Last sentence, rejected as contrary to facts found; the rest, accepted and incorporated to the extent necessary.
See paragraph 25, above.
Rejected in part as not proved in that Helle did
not get most of the tests on follow-up visits and did not always have her pulse taken and or get a thyroid screen on initial visits. Examinations were inadequate only in that Respondent generally did not examine or palpate the patient's neck, did not always take her pulse and did not always either do an electrocardiogram or listen to heart sounds.
Accepted and incorporated to the extent necessary.
Accepted and incorporated.
Accepted and incorporated.
Accepted and incorporated.
Accepted and incorporated.
Accepted except that Helle telephoned Respondent and was advised to try cutting the dosage in half but, in any event, unnecessary.
Accepted but unnecessary, and the first sentence also is subordinate.
Rejected as not proved what medication or program Helle followed on prior occasions. Accepted that Respondent could not have predicted a problem but unnecessary.
Rejected as contrary to facts found.
Accepted and incorporated.
See paragraphs 24 and 41.
As to the first sentence, see paragraphs 25 and 42, above. As to the second sentence, irrelevant.
Rejected in part as not proved in that Hancock did not get most of the tests on follow-up visits. Examinations were inadequate only in that Respondent
generally did not examine or palpate the patient's neck and did not always either do an electrocardiogram
or listen to heart sounds.
Accepted and incorporated to the extent necessary.
Accepted and incorporated.
Accepted and incorporated along with additional findings.
Accepted but unnecessary.
Rejected as not proved but accepted that Respondent thought that was the cause and incorporated.
62.-65. Unnecessary.
COPIES FURNISHED:
Stephanie A. Daniel, Esquire Department of Professional
Regulation
130 North Monroe Street Tallahassee, Florida 32399-0750
Gerald W. Nelson, Esquire Diana K. Wallace, Esquire 4950 West Kennedy Blvd.
Suite 603
Tampa, Florida 33609
Rod Presnell Executive Director
Board of Osteopathic Medical Examiners Department of Professional
Regulation
130 North Monroe Street Tallahassee, Florida 32399-0750
Van Poole Secretary
Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32399-0750
Wings S. Benton, Esquire General Counsel
Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32399-0750
=================================================================
AGENCY FINAL ORDER
================================================================= BEFORE THE BOARD OF OSTEOPATHIC MEDICAL EXAMINERS
DEPARTMENT OF PROFESSIONAL REGULATION,
Petitioner,
DPR CASE NO.: 0047751,
vs. 0048418
0059252
MICHAEL J. WARHOLA, D.O., DOAH CASE NO.: 86-1079
Respondent.
/
FINAL ORDER
Respondent, Michael J. Warhola, D.O., is a licensed osteopathic physician in the State of Florida, having been issued license No. 05 0001256. Petitioner filed an Administrative Complaint seeking suspension, revocation, or disciplinary action against the licensee.
Respondent requested a formal hearing and one was held before the Division of Administrative Hearings. The Recommended Order has been forwarded to the Board pursuant to Section 120.571, F.S.; it is attached to and made a part of this Order.
The Board of Osteopathic Medical Examiners met on June 25, 1988, in Tampa, Florida to take final agency action. The Petitioner was represented by Stephanie Daniel, Esquire; the Respondent was present and represented by Diana Wallace, Esquire. The Board has reviewed the entire record in the case.
FINDINGS OF FACT
The Board adopts the findings of fact of the Hearing Officer. Respondent through counsel had filed 37 exceptions to the findings of fact in the recommended order. With the exceptions of the particular exceptions which were deemed to be cumulative, the Board individually considered each of Respondent's options to the recommended order and denied the exceptions. In doing so, the Board upheld the Hearing Officer's findings of fact as being supported by competent substantial evidence in the record and also relied upon the wri ten responses to the exceptions contained within Petitioner's response to Respondent's exceptions to the recommended order. Notwithstanding the rejection of Respondent's exceptions, paragraphs 36 and 60 of the recommended order were amended as follows:
In paragraph 36 on page 11 of the recommended order, the last sentence was modified to strike the clause, "because the medication codes have changed over
the years,"; the last sentence thus reads: "the identities of the drugs dispensed to Echezabal before May, 1979, are unknown." Additionally, the words "which has since changed" were deleted from the fourth sentence in paragraph 60 on page 17 of the recommended order.
CONCLUSIONS OF LAW
The Board adopted the Hearing Officer's conclusions of law of the recommended order.
Based upon her findings of fact and conclusions of law, the Hearing Officer had recommended that Respondent's license be suspended for 6 months.
Upon review of the entire record, the Board modified the recommended penalty for the following reasons:
The gravity of the charges and the violations of which Respondent was found guilty necessitate a period of continued monitoring of Respondent's practice notwithstanding the length of years Respondent has continued to practice. The Board adopted the 6 month suspension; however, the Board stayed the suspension conditioned upon two year period of probation subject to the following conditions:
Respondent shall comply with all state and federal statutes, rules and regulations pertaining to the practice of medicine, including Chapters 455, 459 and 893, Florida Statutes, and Rules 21R, Florida Administrative Code.
Respondent shall appear before the Board at the first meeting after said probation commences, at the last meeting of the Board preceding termination of probation, and semi-annually.
In the event Respondent leaves the State of Florida for a period of thirty days or more, or otherwise does not engage in the practice of medicine in Florida, Respondent's probation shall be tolled and shall remain in a tolled status until Respondent returns to active practice in the State of Florida, at which time the probationary status shall resume. Respondent must keep current residence and business address on file with the Board. Respondent shall notify the Board within ten (10) days of any changes of said addresses.
Respondent shall work under the indirect supervision of a physician fully licensed under Chapter 459 to be approved by the Board or its probationary committee. Respondent shall have the monitoring physician with him at his first probation appearance before the Board or its probationary committee. Prior to approval of the monitoring physician by the committee, the Respondent shall provide to the monitoring physician a copy of the administrative complaint filed in this case. A failure of the Respondent or the monitoring physician to appear at the scheduled probation committee meeting shall constitute a violation of the Board's Final Order. The responsibilities of the monitoring physician shall include:
Submit quarterly/semi annual reports, in affidavit form which shall include:
Brief statement of why physicians is on probation.
Description of probationer's practice.
Brief statement of probationer's compliance with terms of probation.
Brief description of probationer's relationship with monitoring physician.
Detail any problems which may have arisen with probationer.
Respondent shall be responsible for ensuring that the monitoring physician submits the required reports.
Review all patient records of patients treated for weight control. Review Respondent's prescribing of controlled substances.
Respondent shall submit quarterly/semi-annual reports in affidavit form, the contents of which shall be specified by the Board. The reports shall include:
Brief statement of why physician is on probation.
Practice location.
Describe current practice type and composition.
Brief statement of compliance with probationary terms.
Describe relationship with monitoring/supervising physician.
Advise Board of any problems.
Other.
Respondent shall attend 30 hours of continuing medical education courses, within two years in addition to those hours required for renewal of licensure.
Respondent may prescribe controlled substances with the restrictions set forth below:
Respondent shall utilize sequentially numbered triplicate prescriptions in the prescribing of schedule controlled substances.
Respondent shall provide one copy of each prescription for controlled substances to his monitoring physician.
Respondent shall maintain one copy of each prescription for controlled substances in the patient's record.
Respondent understands that during this period of probation, semi-annual investigative reports will be complied by the Department concerning his compliance with the terms and conditions of probation and the rules and statutes regulating the practice of medicine.
Additionally, Respondent shall pay an administrative fine of $5,000.00 to the Board within 30 days from the filing of this final order. This order takes effect upon filing.
This order may be appealed by filing notices of appeal and a filing fee, as set out in Section 120.68(2), F.S. and Florida Rule of Appellate Procedure 9.110(b)(c) within 30 days of the date of filing.
DONE AND ORDERED this 25th day of July, 1988.
BOARD OF OSTEOPATHIC MEDICAL EXAMINERS
RALPH H. GREENWASSER, D.O., CHAIRMAN
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that a true copy of the foregoing was furnished by hand to Stephanie Daniel, Esquire, Department of Professional Regulation, 130 North Monroe Street, Tallahassee, Florida 32301, by Certified Mail to Michael J. Warhola, D.O., 4221 El Prado Blvd., Tampa, Florida 33609, and by U.S. Mail to Diana Wallace, Esquire, 4600 West Kennedy Blvd., Post Office Box 18607, Tampa, Florida 33679-8607 this 27 day of July, 1988.
| Issue Date | Proceedings |
|---|---|
| Mar. 04, 1987 | Recommended Order (hearing held , 2013). CASE CLOSED. |
| Issue Date | Document | Summary |
|---|---|---|
| Jul. 25, 1988 | Agency Final Order | |
| Mar. 04, 1987 | Recommended Order | Inappropriate and excessive prescription of legend drugs supposedly for weight control. No labeling violations. Inadequate records but lesser included. |
