The Issue The issue is whether the certificate issued to Mr. Ramsey by the Criminal Justice Standards and Training Commission should be revoked for his failure to maintain good moral character through the use of cocaine.
Findings Of Fact Charles Ramsey was issued a certificate on October 2, 1981, by the Criminal Justice Standards and Training Commission, number 19-81-502-01, as a correctional officer. On April 12, 1988, Mr. Ramsey went to the Mount Sinai Medical Center for Industrial Medicine at 4300 Alton Road, Miami Beach, Florida 33140. The overall purpose of the visit was not clear, but as a part of his activities at the Center, Ramsey provided urine specimen for analysis. Before providing the specimen, Ramsey had disrobed, was wearing a hospital gown, and was escorted to a bathroom at the site, where he was given two marked specimen bottles. The first bottle was for the main sample, the second for any overflow if Mr. Ramsey's urine donation was greater than the size of the first bottle. Each bottle was a 60 ml. pharmaceutical round bottle. The specimen bottles had his name on them, a bar code identifying the bottles as bottles from an employee of the Metro-Dade Law Enforcement Department, and the unique specimen number of 117270. At that time, Mr. Ramsey initialed the information on the bottle acknowledging that it was correct. After he exited the bathroom and delivered the urine bottle it was sealed with evidence tape by the technician at Mount Sinai, Sonia Abreu, and was placed in a locked cabinet. The cabinet was opened with a key belonging to the courier for the Toxicology Testing Service of Miami, Florida. The urine was kept under lock and key until it was removed and brought to the screening room at Toxicology Testing Service. The technician there broke the seal and dispensed a sample into an automated clinical analyzer which performed an EMIT screen test on 3 ml. of urine. That test showed the presence of cocaine metabolites, i.e., substances left in the body after cocaine has been ingested and been processed by the metabolic action of the body. Based on this initial positive screening test result, another 3 ml. of the sample was used to perform the screening test again. When the screening test again was positive for cocaine metabolites, a more specific test for the presence of cocaine metabolites was performed by Dr. Terry Hall, who holds his doctorate in chemistry, and has specialized in forensic toxicology. The test was performed using a gas chromatograph and a mass spectrometer. The study showed the presence of methylecganine in the urine, which is a cocaine metabolite. The concentration of the methylecganire in the sample was such that it is likely that Mr. Ramsey used cocaine within the previous two weeks. Exposure to trace amounts of cocaine, such as from airborne cocaine which might be inhaled while measuring cocaine seized as part of a drug arrest, could not have yielded the high level of methylecganine found in Mr. Ramsey's urine. The level of metabolite is such that Mr. Ramsey would have had to ingest approximately 10 grams of cocaine.
Recommendation Based upon the foregoing, it is RECOMMENDED that the certificate held by Charles Ramsey be revoked for failure to maintain good moral character. DONE and ENTERED this 28th day of April, 1989, in Tallahassee, Leon County, Florida. WILLIAM R. DORSEY, JR. Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of April, 1989. COPIES FURNISHED: Joseph S. White, Esquire Florida Department of Law Enforcement Post Office Box 1489 Tallahassee, Florida 32302 Charles Ramsey 1064 Northwest 61st Street Miami, Florida 33127 Daryl McLaughlin, Executive Director Florida Department of Law Enforcement Post Office Box 1489 Tallahassee, Florida 32302 Jeffrey Long, Director Criminal Justice Standards and Training Commission
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.
Recommendation 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.
Findings Of Fact The parties stipulated that Monroe C. Schiffman is a pharmacist licensed by the Florida Board of Pharmacy. They further stipulated that Sharon Drugs, d/b/a Mercy Professional Building pharmacy is located at 3661 south Miami Avenue, Miami, Florida and that Sharon Drugs owns and operates Mercy Professional Building Pharmacy. The parties also stipulated that Monroe C. Schiffman was a corporate officer and share holder in Sharon Drugs, Inc., a Florida corporation, from February 1, 1975 until the dates of the audits in question and that Monroe C. Schiffman was a corporate officer and stockholder in Monroe Pharmacy, Inc. from March, 1974, until the audits in question. An inspection and audit of Sharon Drugs, Inc. d/b/a Mercy Professional Building Pharmacy, was begun on April 23, 1976 and lasted for several days. The audited period was from March 17, 1975 until April 26, 1976, during which dates Monroe C. Schiffman was the registered pharmacist for the operation of Sharon Drugs, Inc. The procedures for the audits were to assume a zero stockage as of March 17, 1975 and to account for the drugs received after that date. The drugs audited were controlled drugs as defined by Chapter 893, Florida Statutes. These drugs were chosen for audit because complete records of their order, receipt and dispensing must be kept pursuant to Chapter 893, Florida Statutes. Exhibit 1, a summary of the audit of Sharon Drugs, Inc., was identified by the Board's agent, Vernon K. Bell, as the summary of the discrepancies in controlled drugs revealed by the audit which he conducted. The audit conducted by Vernon K. Bell revealed a shortage of controlled drugs for which no records had been kept of 296,481 total units or pills. The drugs audited were Desoxyn (methamphetamine hydrochloride), Tuinal (sodium amobarbital and sodium secobarbital), Biphetamine (d- and dl-Amphetamine), Dilaudid (hydromorphone), Nembutal (sodium pentobarbital), Seconal (sodium secobarbital), Quaalude (methaqualone), Eskatrol Spansule (dextroamphetamine sulfate and prochlorperazine) , and Dexedrine (dextroamphetamine sulfate). Monroe C. Schiffman, while the registered pharmacist at Mercy Professional Building Pharmacy, did not keep the record required to be kept by law.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the license and registration of Monroe Charles Schiffman be revoked. DONE and ENTERED this 5th day of January, 1977, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Michael Schwartz, Esquire Suite 201, Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 Gerald Kogan, Esquire Suite 500 Security Trust Building 700 Brickell Avenue Miami, Florida 33131 H. F. Bevis, Executive Secretary State Board of Pharmacy 252 East Sixth Avenue Box 3355 Tallahassee, Florida 32303
The Issue The issue in this case is whether Florida Administrative Code Rule 64B16-27.500(6) regarding the negative drug formulary is an invalid exercise of delegated legislative authority within the meaning of Subsection 120.52(8), Florida Statutes (2007).1
Findings Of Fact Levothyroxine Sodium is a drug used to treat Hypothyroidism and Pituitary TSH Suppression. Mylan develops, manufactures, and sells generic pharmaceuticals and is licensed as a non-resident prescription drug manufacturer and an out-of-state prescription drug wholesaler in Florida pursuant to Section 499.01, Florida Statutes. Mylan has received approval from the United States Food and Drug Administration (FDA) to market 12 strengths of generic Levothyroxine Sodium tablets, which the FDA has determined to be bioequivalent and therefore therapeutically equivalent to corresponding strengths of four reference listed drugs2: Unithorid® tablets, Synthroid® tablets, Levoxyl® tablets, and Levothroid® tablets. Abbott is the manufacturer of Synthroid®, a Levothyroxine Sodium product marketed in Florida and other places. The Board of Pharmacy “has authority to adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of [Chapter 465] conferring duties upon it.” § 465.005, Fla. Stat. Subsection 465.025(6), Florida Statutes, provides: The Board of Pharmacy and the Board of Medicine shall establish by rule a formulary or generic drug type and brand name drug products which are determined by the boards to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, would pose a threat to the health and safety of patients receiving prescription medication. Subsection 465.025(1)(a), Florida Statutes, defines “brand name” as “the registered trademark name given to a drug product by its manufacturer, labeler, or distributor.” “Generically equivalent drug product” is defined in Subsection 465.025(1)(b), Florida Statutes, as “a drug product with the same active ingredient, finished dosage form, and strength.” Subsection 465.025(2), Florida Statutes, provides: A pharmacist who receives a prescription for a brand name drug shall, unless requested otherwise by the purchaser, substitute a less expensive, generically equivalent drug product that is: Distributed by a business entity doing business, and subject to suit and service of legal process, in the United States; and Listed in the formulary of generic and brand name products as provided in subsection (5) for the brand name drug prescribed unless the prescriber writes the words “MEDICALLY NECESSARY,” in her or his own handwriting, on the face of a written prescription; unless, in the case of an oral prescription, the prescriber expressly indicates to the pharmacist that the brand name drug prescribed is medically necessary; or unless, in the case of a prescription that is electronically generated and transmitted, the prescriber makes an overt act when transmitting the prescription to indicate that the brand name drug prescribed is medically necessary. When done in conjunction with the electronic transmission of the prescription, the prescriber’s overt act indicates to the pharmacist that the brand name drug prescribed is medically necessary. Subsection 465.025(5), Florida Statutes, provides: Each community pharmacy shall establish a formulary of generic and brand name drug products which, if selected as the drug product of choice, would not pose a threat to the health and safety of patients receiving prescription medication. In compiling the list of generic and brand name drug products for inclusion in the formulary, the pharmacist shall rely on drug product research, testing, information, and formularies compiled by other pharmacies, by states, by the United States Department of Health, Education, and Welfare, by the United States Department of Health and Human Services, or by any other source which the pharmacist deems reliable. Each community pharmacy shall make such formulary available to the public, the Board of Pharmacy, or any physician requesting same. The formulary shall be revised following each addition, deletion, or modification of said formulary. If a brand name drug or a generic drug type drug product is listed on the negative drug formulary established by the Board of Pharmacy and Board of Medicine, a pharmacist is prohibited from substituting a generically equivalent drug product for a prescribed brand name drug product. § 465.025(6)(b), Fla. Stat. The Board of Pharmacy has adopted a negative drug formulary which is contained in Florida Administrative Code Rule 64B16-27.500, and Levothyroxine Sodium is listed on the negative drug formulary. Thus, Mylan’s generic products currently cannot be substituted where a prescription is written for a brand name Levothyroxine Sodium product. Mylan has challenged Florida Administrative Code Rule 64B16-27.500(6), which provides: The negative drug formulary is composed of medicinal drugs which have been specifically determined by the Board of Pharmacy and the Board of Medicine to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, could produce adverse clinical effects, or could otherwise pose a threat to the health and safety of patients receiving such prescription medications. Except where certain dosage forms are included on the negative drug formulary as a class, all medicinal drugs are listed by their official United States Pharmacopoeia Non-Proprietary (generic) name. The generic name of a drug shall be applicable to and include all brand-name equivalents of such drug for which a prescriber may write a prescription. Substitution by a dispensing pharmacist on a prescription written for any brand name equivalent of a generic named drug product listed on the negative drug formulary or for a drug within the class of certain dosage forms as listed, is strictly prohibited. In cases where the prescription is written for a drug listed on the negative drug formulary but a name brand equivalent is not specified by the prescriber, the drug dispensed must be one obtained from a manufacturer or distributor holding an approved new drug application or abbreviated new drug application issued by the Food and Drug Administration, United States Department of Health and Welfare permitting that manufacturer or distributor to market those medicinal drugs or when the former is not applicable, those manufacturers or distributors supplying such medicinal drugs must show compliance with other applicable Federal Food and Drug Administration marketing requirements. The following are included on the negative drug formulary: * * * (6) Levothyroxine Sodium. Subsection 465.0251(1), Florida Statutes, provides: The Board of Pharmacy and the Board of Medicine shall remove any generic named drug product from the formulary established by s. 465.025(6), if every commercially marketed equivalent of that drug is “A” rated as therapeutically equivalent to a reference listed drug or is a reference listed drug as referred to in “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) published by the United States Food and Drug Administration. The Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act. It also includes therapeutic equivalence evaluations for approved multisource prescription drug products. The Orange Book is updated annually and is supplemented with monthly cumulative updates. Additionally, the FDA has a website containing an electronic version of the Orange Book, which is also updated. The Orange Book used in 2007 is the 27th Edition. The Orange Book in effect at the date of the enactment of Section 465.0251, Florida Statutes,3 was the 21st Edition. Generally, approval by the FDA is required before a prescription drug product may be marketed, distributed, or sold in the United States. See 21 U.S.C. § 355(a). When a product contains a new active ingredient or otherwise differs significantly from previously approved products, the sponsor must provide the FDA with data demonstrating the product’s safety and effectiveness for the intended use. See, e.g., 21 U.S.C. § 355(b). When a product is a copy of a previously approved product—-what is commonly called a “generic” version of the original drug—-proof of safety and effectiveness is not required. Instead, the FDA requires a showing that, with regard to certain characteristics, the proposed generic product is essentially the same as the approved product it purports to copy, which is called the “reference listed drug.” See 21 U.S.C. § 355(j). The FDA’s previous finding that the reference listed drug is safe and effective is then imputed to the generic product. In general, the generic product must contain the same active ingredient in the same strength, and it must be in the same dosage form (e.g., tablet, capsule, solution) as the reference listed drug. See 21 U.S.C. § 355(j). Products that share these characteristics are considered “pharmaceutical equivalents” by the FDA. Orange Book, 27th Ed., at v-vi (Jan. 2007). Subsection 465.025(1)(b), Florida Statutes, uses the term “generically equivalent drug products” to describe such products. “Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.” Orange Book, 27th Ed. at vi. The FDA classifies as therapeutically equivalent those products that meet the following criteria: they are approved as safe and effective; they are pharmaceutical equivalents in that they (a) contain identical amounts of the same active drug ingredient in the same dosage form and same route of administration, and (b) meet compendial or other applicable standards of strength, quality, purity, and identity; (3) they are bioequivalent in that (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard; (4) they are adequately labeled; (5) they are manufactured in compliance with Current Good Practice Manufacturing Practice regulations. Id. These criteria are essentially the same criteria that existed in 2001 as shown in the final staff analysis of HB69, which was passed and became Chapter 2001-146, Laws of Florida, now codified as Section 465.0251, Florida Statutes. Drug products that have been relied on as reference listed drugs are so identified in the Orange Book, and products that are therapeutically equivalent to each other are identified by a shared therapeutic equivalence evaluation code (TE code). These are primarily, but not exclusively, reference listed drugs and the generic drugs approved on the grounds of pharmaceutical equivalence and bioequivalence to those reference listed drugs. Generally, the FDA uses a two-letter TE code, with a code of “AB” given to solid oral dosage form products that have demonstrated therapeutic equivalence. Orange Book, 27th Ed. at xii-xiii. For the vast majority of most multi-source drugs, there is one product that is the reference listed drug and one or more generic versions of that product, and all the products share a TE code of AB. However, there are situations in which there is more than one reference listed drug. These situations are discussed in the Orange Book, 27th Ed. at xiv. In certain instance, a number is added to the end of the AB code to make a three character code ( i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. . . . Drugs coded as AB under a heading are considered therapeutically equivalent only to other drugs coded as AB under that heading. Drugs coded with a three-character code under a heading are considered therapeutically equivalent only to other drugs coded with the same three- character code under that heading. The FDA first officially described the three-character code rating system in the 16th edition of the Orange Book in 1996. Levothyroxine Sodium tablets are a drug product for which there are multiple reference listed drugs. Currently the Orange Book identifies seven Levothyroxine Sodium products approved for sale in the United States: Synthroid®, Levo-T®, Levoxyl®, Levothroid®, Unithroid®, a generic-named product manufactured by Genpharm, and a generic manufactured by Mylan. The current Orange Book also contains the following levothyroxine sodium products in a section identifying “Discontinued” products that, although approved for distribution in the United States, are not being marketed: Novothyrox, Levolet, and Tirosint. The following drug products are currently identified in the Orange Book as reference listed drugs: Synthroid®, Levo-T®, Levoxyl®, Levothroid®, and Unithroid®. In the case of Levothyroxine Sodium products, not all the reference listed drugs are considered therapeutically equivalent to one another. The Orange Book discusses this situation and explains the therapeutic evaluations for Levothyroxine Sodium products as follows: Because there are multiple reference listed drugs of levothyroxine sodium tablets and some reference listed drugs’ sponsors have conducted studies to establish their drugs’ therapeutic equivalence to other reference listed drugs, FDA has determined that its usual practice of assigning two or three character TE codes may be potentially confusing and inadequate for these drug products. Accordingly, FDA provides the following explanation and chart of therapeutic equivalence evaluations for levothyroxine sodium products. Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Unithroid (Jerome Stevens NDA 021210) tablets. Levo-T (Alara NDA 021342), Levothyroxine Sodium (Mylan ANDA 76187), Unithroid (Jerome Stevens NDA 021210) and Levothyroxine Sodium (Genpharm ANDA 76752) tablets have been determined to be therapeutically equivalent to corresponding strengths of Synthroid (Abbott NDA 021402) tablets. Levo-T (Alara NDA 021342), Unithroid (Jerome Stevens NDA 021210), Levothyroxine Sodium (Mylan ANDA 076187) and Levothyroxine Sodium (Genpharm ANDA 76752) tablets have been determined to be therapeutically equivalent to corresponding strengths of Levoxyl (King/Jones Pharma NDA 021301) tablets. Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Levothroid (Lloyd NDA 021116) tablets. Novothyrox (Genpharm NDA 021292) requires further investigation and review to establish therapeutic equivalence to corresponding strengths of any other Levothyroxine Sodium drug products and is rated BX. Levolet (Vintage NDA 021137) requires further investigation and review to establish therapeutic equivalence to corresponding strengths of any other Levothyroxine Sodium drug products and is rated BX. The chart outlines TE codes for all 0.025mg products with other products being similar. Therapeutic equivalence has been established between products that have the same AB+number TE code. More than one TE code may apply to some products. One common TE code indicates therapeutic equivalence between products. Trade Name Applicant Potency TE CODE Appl No Product No UNITHROID STEVENS J 0.025mg AB1 21210 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB1 76187 001 LEVOXYL JONES PHARMA 0.025mg AB1 21301 001 SYNTHROID ABBOTT 0.025mg AB1 21402 001 SYNTHROID ABBOTT 0.025mg AB2 21402 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB2 76187 001 LEVO-T ALARA PHARM 0.025mg AB2 21342 001 UNITHROID STEVENS J 0.025mg AB2 21210 001 LEVOTHYROXINE SODIUM GENPHARM 0.025mg AB2 76752 001 LEVOXYL JONES PHARMA 0.025mg AB3 21301 001 LEVO-T ALARA PHARM 0.025mg AB3 21342 001 UNITHROID STEVENS J 0.025mg AB3 21210 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB3 76187 001 LEVOTHYROXINE SODIUM GENPHARM 0.025mg AB3 76752 001 LEVOTHROID LLOYD 0.025mg AB4 21116 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB4 76187 001 NOVOTHYROX GENPHARM 0.025mg BX 21292 001 LEVOLET VINTAGE PHARMS 0.025mg BX 21137 001 Orange Book, 27th Ed. at xix-xx. In the Orange Book, 21st Ed. (Cumulative Supplement 6, June 2001), only two Levothyroxine Sodium tablet products were listed, Levoxyl® and Unithroid®, and both were rated as BX, meaning that the data that had been reviewed by FDA was insufficient to determine therapeutic equivalence. There were also 12 additional Levothryroxine Sodium products that were being commercially marketed in the United States and were not listed in the Orange Book.
Findings Of Fact At all times material hereto, Respondent has been a medical doctor having been issued license number 0029773 by the State of Florida. At all times material hereto, Respondent was an employee of the Atlantic Stress and Obesity Clinic, Inc., located in North Miami Beach, Florida. While employed there, Respondent treated Daniel Wolfenstein, Cindy Vegazo, Neal Schoenberg, James F. McDonald, Scott Brown and Virginia Hagerty at the Clinic. On or about October 9, 1981, Respondent prescribed 45 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Daniel Wolfenstein. Respondent did not prescribe the above-described controlled substance to Daniel Wolfenstein for a medically justifiable purpose. That prescription was inappropriate and in an excessive or inappropriate quantity. Between the dates of approximately March 10, 1981, and February 8, 1982, Respondent prescribed 405 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Cindy Vegazo. Respondent did not prescribe the above-described controlled substance to Cindy Vegazo for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. Between the dates of approximately October 9, 1981, and January 5, 1952, Respondent prescribed 90 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for Neal Schoenberg. Respondent did not prescribe the above-described controlled substance to Neal Schoenberg for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. Between the dates of approximately September 9, 1981, and January 22, 1952, Respondent prescribed 225 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for James F. McDonald. Respondent did not prescribe the above-described controlled substance to James F. McDonald for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. On or about October 13, 1981, Respondent prescribed 45 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for Scott Brown. Respondent did not prescribe the above-described controlled substance to Scott Brown for a medically justifiable purpose. Said prescription was inappropriate and in excessive or inappropriate quantity. Between the dates of approximately August 4, 1981, and December 29, 1981, Respondent prescribed 135 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Virginia Hagerty. Respondent did not prescribe the above-described controlled substance to Virginia Hagerty for a medically justifiable purpose. Said prescriptions were inappropriate and in excessive or inappropriate quantities. The medical records of each of the above-listed patients indicate that each patient was given a prescription for 45 methaqualone tablets each time that patient came to the Atlantic Stress and Obesity Clinic to see Respondent. All patients indicated on the form checklist given to them at the Clinic that they were seeking medical aid because they were depressed, tense, unable to sleep, and/or without ambition. The progress notes for each patient are identical to the notes from prior visits, all progress notes appear in two different handwritings, and all patients are diagnosed as suffering from anxiety and insomnia, thereby requiring 45 more methaqualone tablets. There appears no variation in dosage or in diagnosis. Methaqualone is a depressant, and, therefore, prescribing methaqualone to depressed patients is contraindicted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent guilty of Counts I through XIX of the Administrative Complaint and permanently revoking Respondent's license to practice medicine in the State of Florida. DONE and RECOMMENDED this 27th day of July, 1983, in Tallahassee, Leon County, Florida. LINDA M. RIGOT, 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 27th day of July, 1983. COPIES FURNISHED: Charlie L. Adams, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Adolfo Z. Aguila, Esquire Midway Professional Building 55 Grand Canal Drive, Suite 404 Miami, Florida 33144 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy J. Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301
