Findings Of Fact Respondent is a medical doctor, licensed to practice in Florida, and holds license number ME 0009310, issued by Petitioner. Respondent specializes in family practice and has been board certified by the American Academy of Family Physicians since 1974. Percodan is the manufacturer's brand name for oxycodone, which is a Schedule II controlled substance pursuant to Chapter 893, F.S. 2/ It is a drug used for the relief of pain, a synthetic analgesic, and is both a physically and psychologically dependent producing drug. It can cause drowsiness, urinary retention, nausea, vomiting, and interacts unfavorably with other sedative drugs, and is considered a depressant. On December 30, 1966, Evelyn Milstead, a 30 year old woman, came to Respondent's office complaining of nausea and a rash in her mouth. Respondent conducted a physical examination, took her medical history and thereafter prescribed tigan for the nausea. Ms. Milstead became a regular patient of Respondent's and he continued treating her for various ailments over a period of years. During the course of Respondent's treatment, Milstead developed a chronic urinary tract infection and kidney condition in which she passed kidney stones. On occasion Milstead was treated by Dr. Gillespie, a specialist in the field of urology for her kidney condition. In 1978, Respondent also referred instead to the Ochsner Clinic for evaluation of her urinary tract and kidney problems. She was evaluated at Ochsner Clinic and received prescriptions for darvocet, a pain medication, and keflex, an antibiotic, and was told that she would continue to have a chronic kidney problem. Over the years, Milstead was hospitalized several times by Dr. Gillespie for treatment of her kidney condition. The testimony of Dr. William H. Nass and Dr. Robert P. Johnson established that Respondent's initial prescriptions of percodan to Milstead were appropriate. However, Respondent's percodan prescriptions to Milstead eventually became inappropriate. Specifically, the prescriptions for 2,668 percodan tablets between August, 1980 and November, 1982, were established as excessive. On July 30, 1977, Bruce White, a 25 year old male, came to Respondent for medical treatment for headaches and thereafter returned to Respondent for treatment of various medical problems. Mr. White's wife, Vicki White, and their children were also seen by Respondent as their family doctor. On May 18, 1981, White came to Respondent complaining of neck and back pain from an automobile accident in which he also fractured his left lower leg. Respondent noted that White had been seen by a neurologist and an orthopedic surgeon for his head and leg. In addition to other medication, Respondent prescribed percodan to White for pain. White had also developed arthritis in his left leg, as a result of the car accident and fracture, and on one occasion was hospitalized for swelling of his left leg. Respondent referred White to Dr. Tippett, a neurosurgeon, concerning his headaches and to Dr. Graybiel, a rheumatologist, concerning his arthritis. However, White continued to see Respondent as his medical doctor because his work schedule on an offshore oil rig would only permit Saturday appointments with his doctor and Respondent's offices are open on Saturday mornings. White also found it difficult to pay the fees charged by specialists. Between May 8, 1981 and September 30, 1982, Respondent prescribed 780 percodan tablets for Bruce White. The testimony of Dr. Nass and Dr. Johnson established that Respondent's initial prescriptions of percodan to White were appropriate. However, the percodan prescriptions to White became inappropriate over time due to their excessiveness. The seriousness of this lapse is underscored by Respondent's failure to try other pain alleviating measures and failure to investigate abuse possibilities. On October 18, 1979, Vicki White, the wife of Bruce White, a 23 year old woman, came to Respondent's office seeking treatment. She complained of migraine headaches and stated that her father was in the hospital with cancer. She also stated that she had seen Dr. Eyser, a neurosurgeon, for her headaches. Respondent prescribed wygesic for her pain. She subsequently returned to Respondent for treatment of various complaints including chronic migraine headaches, colds, and a dislocated right shoulder. Initially, Respondent prescribed norcet for relief of this pain, and on July 31, 1981, first prescribed percodan for her migraine headaches. Respondent prescribed percodan on other occasions in response to her complaints of pain from migraine headaches and back strain. Respondent considered referring her to a neurologist for the headaches but White stated that she could not afford to see a specialist. Respondent prescribed 590 percodan tablets for Vicki White between July 31, 1981 and September 22, 1982. Percodan is an appropriate and acceptable medicine for the relief of migraine headaches, and Respondent's initial prescription of percodan to Ms. White was appropriate. However, his prescriptions became excessive over time since percodan is not to be used for long term treatment of migraine headaches. On September 7, 1982, M. D. Medlen, an Escambia County Deputy Sheriff, went to Respondent's office as an undercover police officer, under the assumed name of Donna Slay. She had been asked by Robert Powers, a narcotics officer with the Escambia County Sheriff's Department and Charles Deckard, an investigator with the Department of Professional Regulation, to go to Respondent's office in an undercover capacity and attempt to obtain a prescription for percodan. Medlen/Slay first gave general information to the receptionist, including identification, in the name of Donna Slay, chief complaint of a backache, previous illnesses, drug allergies, address, social security number, and insurance information. Medlen/Slay was shown to an examination room where her blood pressure and weight were taken by the nurse and a urinalysis was performed. Respondent then came in and asked Medlen/Slay what her problem was. She informed him that she had been pushed into a wall during a fight, and had injured her back. Respondent checked her pulse, did a range of motion test, and checked the alleged injured area by palpation. Each time Respondent pressed on the alleged injured area, Medlen/Slay told him it hurt. Respondent did not visually inspect the alleged injured area but asked Medlan/Slay if there was a bruise and she said no. In order to get the percodan, Medlen/Slay told Respondent that she had injured her back one other time and a doctor in Louisiana had prescribed percodan for that injury. Respondent asked how long ago Medlen/Slay had taken the percodan and she said one year ago. Respondent discussed the dangers of drug addiction with Medlan/Slay and then prescribed 20 tablets of percodan for pain and 30 tablets of indocin to reduce inflammation. Upon leaving Respondent's office, Medlen/Slay did not fill the prescriptions but turned them over to Deckard. Percodan is an acceptable medicine for back and shoulder pain. However, Respondent should have considered the possibility of fracture, visually examined the area to ascertain the presence of a hematoma (blood clot) and listened to the patient's chest to determine the presence of lung injury. Respondent did not perform an appropriate examination prior to prescribing percodan, and the prescription was therefore inappropriate. Respondent used poor judgment in his excessive prescriptions of percodan to the patients discussed herein. However, there is no evidence that Respondent prescribed the percodan for personal financial gain or that any patient was injured by Respondent's prescribing practices. The testimony of the expert witness established that the records maintained on these patients were inadequate. Frequently, the only notation for a given visit was the prescription for percodan, with no evaluation of the patient's condition. Further, Respondent's patient records did not even list all the percodan prescriptions issued. Thus, these records essentially reflect partial inventories of prescriptions issued, and do not justify the course of prescribing, which is important to the safe practice of medicine.
Recommendation Based on the foregoing, it is RECOMMENDED that Petitioner enter a final order placing Respondent on probation for a period of five years, require that Respondent practice under the supervision of another physician to be named by Petitioner during the initial year of his probation and that Petitioner restrict Respondent's license against prescribing Schedule II controlled substances while he is under such supervision. 4/ DONE and ENTERED this 24th day of April, 1984 in Tallahassee, Florida. R. T. CARPENTER, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of April, 1984.
The Issue The matters presented for consideration in this case concern an administrative complaint brought by the Petitioner against the Respondent. That complaint alleges violations of various provisions of Chapter 458, Florida Statutes. Those sections of law are more particularly described in the conclusions of law in this Recommended Order. In summary, Respondent is alleged, in the course of his relationship with patients under his care, to have prescribed numerous controlled substances which were in excessive amounts, and were not appropriate prescriptions for the medical problems experienced by the patients, and were not prescribed in the course of the Respondent's professional practice. In the face of these circumstances, Respondent is accused of having committed gross or repeated malpractice in failing to recognized by reasonably prudent similar physicians in his community. Respondent is also accused of having failed to keep written medical records justifying the course of treatment.
Findings Of Fact Teotimo D. Bonzon, M.D., is a physician licensed to practice medicine in Florida through licensure by the State of Florida, Department of Professional Regulation, Board of Medical Examiners, license No. MF0016786. He has held this license at all times relevant to this inquiry and during this period has practiced medicine at 830 Gary Street, Jacksonville, Florida, and 6229 Merrill Road, Jacksonville, Florida. At present, Respondent does general surgery approximately three times a week and sees 30-35 patients a day in his general office practice. Dr. Bonzon is a graduate of the medical school, Far Eastern University, Manila, the Philippines. The date of his graduation was 1961. In 1962, he took his internship at St. Francis Hospital in Jersey City, New Jersey. There followed five years of general surgery training at Booth Medical Center in Flushing, New York, and York Hospital in York, Pennsylvania. Respondent then took a year of surgical fellowship at the Community General Hospital of Syracuse, New York. Following this practice, Respondent stood examination for medical license to practice in the State of Florida, and in the States of Pennsylvania and Indiana. Having passed those examinations, the decision was made to move to Florida. Respondent arrived in Florida in June of 1971 and has been involved in the practice of general surgery and general office practice since that time. The initial two years in practice in Florida were primarily concerned with general surgery and industrial medicine, which relates to provision of care for those persons who have been injured in industrial accidents. The administrative complaint, which is the subject of this controversy, dates from March 10, 1982, and is the result of a survey made by the State of Florida, Department of number of Schedule II controlled substances per Chapter 893, Florida Statutes, which had been prescribed by physicians who practice in the Jacksonville, Florida, area. This survey transpired over a period of approximately six months, beginning in the fall of 1981. After being properly served with the administrative complaint, Respondent made a timely request for a formal hearing pursuant to Subsection 120.57(1), Florida Statutes. ARTHUR LEE SCHEIDER (Counts I, II, IV, V) Dr. Bonzon first saw Arthur Scheider in his office on May 29, 1979. At that time, the chief complaints of the patient had to do with "nerves, that the patient could not sleep, that he itched and broke out in a rash." These matters are reflected on the copy of the patient's records, which are admitted as Petitioner's Exhibit C. Additionally, it was noted that the patient had been utilizing methaqualone or Quaaludes for one year prior to being seen by Dr. Bonzon. Scheider had also been receiving Valium in 10 milligram amounts. On this date, Dr. Bonzon prescribed 100, 300-milligram Quaaludes to assist the patient in sleeping and 100, 10-milligram Valium tablets related to the nervous problem being experienced by the patient. Both of these drugs are Schedule II controlled substances with a potential for abuse by those persons for whom the prescription has been given. Methaqualone is a sleep producer. Valium is a muscle relaxer. Scheider was again seen on August 20, 1979, still complaining of nervousness and problems with sleep together with a rash condition on his torso and extremities. At that time, a further prescription of Quaaludes in the amount of 100 at 300-milligram each and Valium in the amount of 100 at 10- milligram each were prescribed for the patient with the opportunity for one refill related to the Valium. On November 1, 1979, the patient returned and based upon a diagnostic note in the patient's records to the effect that the patient needed nerve medicine, a further prescription Valium with opportunity for one refill was prescribed. These prescriptions were given on November 1, 1979, before the amounts related to the August 20, 1979, prescription for Quaaludes and Valium had been exhausted. This is based upon Dr. Bonzon's appropriate recommendation that no more than one Valium and one Quaalude tablet be taken per day. On January 7, 1980, a brother of the patient Scheider asked for Quaalude medication and was denied. The request for medication is reflected in the aforementioned exhibit related to patient records of Scheider. Scheider was again seen on March 14, 1980, complaining of laryngitis, cough, and of a fever in the range of 100 degrees. On that date, in addition to other medication, 100, 300-milligram Quaaludes and 100, 10-milligram Valium were prescribed for the patient. No explanation is made as to why Quaaludes and Valium were prescribed. On May 19, 1980, the patient record reflects that 50, 10-milligram Valium were prescribed for the patient Scheider; no indication is made as to the reason for this prescription. The Valium prescription was given at a time prior to the exhaustion of the March 14, 1980, prescription for Valium based upon a utilization rate of one Valium tablet per day. On June 11, 1980, a sister of Arthur Lee Scheider's called and spoke to the Respondent and told the Respondent that Arthur Lee Scheider had been selling Valium to Scheider's mother. As a consequence, Dr. Bonzon noted in the patient record that he would not prescribe Valium for Scheider in the future and in fact abided by this choice. Respondent did prescribe 100, 300-milligram strength methaqualone tablets on this date. On September 12, 1980, Scheider was again seen by the Respondent reference an examination which led to the conclusion that the patient needed an operation related to a circumcision. At that time, 100 additional 300-milligram Quaaludes were prescribed for the patient. Prescribed methaqualone or Quaaludes for the patient Scheider, it was always on the basis that Dr. Bonzon felt that the patient needed assistance in sleeping. Although not reflected in the medical record, Bonzon had suggested to Scheider that he see a psychiatrist in trying to combat his problem with sleep; however, Scheider declined this suggestion and the Respondent continued to prescribe methaqualone or Quaaludes. These prescriptions of 100 were made, notwithstanding the fact that the Physicians' Desk Reference indicated that methaqualone or Quaaludes should be prescribed in "small quantities." Respondent believes that this suggestion is a relative matter and really intends that the patients not be allowed to take more than one methaqualone tablet per day, an erroneous assumption. Respondent learned of Scheider's trafficking in the controlled substance, methaqualone, on November 25, 1980, and made a note in the patient's file that the patient had been arrested for this activity and that no more medication should be prescribed for this patient for drugs which were under "narcotic control." It was also indicated that appointments for this patient should pertain to other medical problems unrelated to controlled substances. Dr. Ensor R. Dunsford practices medicine in Jacksonville, Florida. He has, during his career, practiced in general surgery and is board certified in that field. His present practice involves emergency treatment in a freestanding emergency care facility. Upon examination of the patient records related to Arthur Lee Scheider, involving the prescription of methaqualone and Valium over the period May 19, 1979, through September 12, 1980, Dr. Dunsford was of the opinion that the act of prescribing was "grossly overdone." Further, Dr. Dunsford felt that this amount prescribed was risky for a patient because of the potential for abuse. If the patient has an emotional need for the substance, then the risk is there that a physical need might be created. In summary, Dr. Dunsford felt that the number of Valium and methaqualone tablets which were in the best interest of the patient. Moreover, Dr. Dunsford felt that the amounts of methaqualone and Valium which Respondent prescribed for Scheider over the period of time were not acts of a "reasonably prudent physician" related to practicing medicine with a level of care, skill and treatment performed by a similar physician in the community. Dr. Dunsford also expressed the opinion that the decision to prescribe the additional methaqualone or Quaaludes on June 11, 1980, and September 12, 1980, after receiving information that the patient was selling a controlled substance (the information of June 11, 1980, from patient's sister related to Valium) was inappropriate and a reflection of substandard medical judgment. To Dr. Dunsford, the information that was given by the sister of patient Scheider was a "red flag" waving in the face of the practitioner, Dr. Bonzon. Dr. Dunsford also states that the September 12, 1980, medical record does not establish a basis for prescribing Quaaludes related to symptomology of the patient. The record makes no reference to the problem with sleeping and pertains only to scrotal erythema, parietitis and the need for circumcision. Finally, given the facts of the prescriptions from May 29, 1979, through September 12, 1980, with emphasis on the information related to suspected drug sales which was imparted on June 11, 1980, Dr. Dunsford feels that a reasonably prudent physician would not want to be involved with that type of situation, i.e. prescribing the drugs on June 11, 1980, and September 12, 1980. All opinions, as expressed by Dr. Dunsford found above are accepted. Dr. Apolinar C. Ilano gave testimony. Dr. Ilano practices in Jacksonville, Florida, as a general surgeon. Dr. Ilano agrees with Dr. Dunsford that methaqualone has a potential for abuse. Following review of the patient records of Arthur Lee Scheider, Dr. Ilano's opinion was that some record had been made which justified the prescription of methaqualone for the sleep problem of Scheider and Valium related to the nervous problem of that patient. The justification found by Dr. Ilano does not satifactorily explain the lack of explanation for prescribing methaqualone on September 12, 1980, as referred to by Dr. Dunsford. Dr. Ilano did not feel that the amounts of methaqualone and Valium that were prescribed to Scheider were excessive or inappropriate or contrary to good judgment by reasonably prudent similar physicians in that there was some justification for prescribing the medication to be found in the record; no indication in the record that the patient was abusing Valium, as opposed to sticking to the amount or dosage prescribed, and the rationalization that Dr. Bonzon was attempting to limit the number of office visits by prescribing the high amounts of methaqualone and Valium. The opinion expressed in the prior sentence is not compelling in the face of facts presented and the more acceptable explanation offered by Dr. Dunsford. Even Dr. Ilano was concerned about prescribing methaqualone after learning that the patient was possibly selling Valium, although his opinion did not reach the level of finding fault with the quality of care offered by Dr. Bonzon in prescribing methaqualone after being informed of the possible sale of Valium, as Dr. Dunsford had. Again, Dr. Dunsford's opinion is accepted on this topic. Dr. Ilano correctly states that if the patient is selling Valium he might in turn sell methaqualone. Dr. Osbey L. Sayler gave testimony related to the care and treatment of Arthur Lee Scheider. Dr. Sayler practices in Orange Park, Florida, and is a board-certified general surgeon. The sum and substance of Dr. Saylor's opinion of Dr. Bonzon's care and treatment of Arthur Lee Scheider was to the effect that Dr. Bonzon had done nothing inappropriate as alleged in the various counts pertaining to that patient. After considering this opinion testimony and that of the other physicians, Dr. Saylor's opinions are accepted to the extent that they describe methaqualone as being an addictive or habit-forming drug which has been resorted to by persons attempting suicide and which is sold on the street as a "downer" and his opinion that Valium has a potential for abuse and can be addictive. Otherwise Dr. Sayler's opinions are rejected. GLADYS KNIGHT (Counts VI, XII, and XIII) Respondent treated the patient Gladys Knight over a period of years. During that time, the patient was seen on April 28, 1981, and was prescribed 30, 10-milligram Ritalin tablets. Ritalin is a Schedule II controlled substance. A notation of the prescription may be found in Petitioner's Exhibit D admitted into evidence, a copy of the patient records kept by the Respondent related to Gladys Knight. As established through the testimony of Dr. Dunsford, no indication is made in those records of an acceptable reason for prescribing Ritalin which is in the category of amphetamine or sympathomimetic amine drugs, spoke to in Section 458.331(1)(cc) , Florida Statutes. The underlying diagnostic impression upon the April 28, 1981, visit, according to the patient records related to complaints of the inability to get out of bed because of fatigue and insomnia. Remarks are also made in that entry that the patient is without energy and is complaining of arthritis pain in her right shoulder. None of these matters comport with a justifiable basis for prescribing ritalin as allowed in Section 458.331(1)(cc), Florida Statutes. In discussing the prescription of Ritalin, Dr. Bonzon indicated in the course of the hearing that he recognized Ritalin to be a central nervous system stimulant, which it is, and that he prescribed it for Mrs. Knight on April 28, 1981, because of his perception of signs of depression in that patient. More particularly, Dr. Bonzon indicated that she had claimed she didn't have energy, didn't want to get out of bed and was recalling a time when her husband was still alive. As a consequence, Bonzon felt that on this one occasion, in his medical judgment, Knight would benefit from a short term use of Ritalin. This was the only prescription of that substance for the patient. No mention was made in the patient record of the depressed condition; however, this impression which was given of the patient's condition in the course of the hearing is not sufficient justification for the prescription of Ritalin, "depressed state" not being one of the accepted bases for prescribing Ritalin as related in Section 458.331(1)(cc), Florida Statutes. Respondent also prescribed Preludin to the patient, Gladys Knight, commencing February 22, 1979. Preludin is a Schedule II controlled substance. This drug was prescribed for purposes of weight control. On the initial date, the patient was provided with 30 tablets with the opportunity for three refills. At that time, the patient weighed 148 pounds. The patient was seen again on August 14, 1979, for weight control and 50 Preludin tables were prescribed with the opportunity for one refill. This visit was made with a Dr. Lagman. At that time, the patient weighed 145 pounds. On September 27, 1979, the patient was seen by the Respondent and was given a further prescription of Preludin to control her weight. She weighed 143 pounds upon that visit. On December 3, 1979, the Respondent saw the patient again and prescribed Preludin in the amount of 100 tablets for weight control. At that time, the patient weighed 146 pounds. Finally, the patient was seen by the Respondent on February 14, 1980, her weight was shown to be 143 pounds and she was given a further prescription of Preludin in the amount of 100 tablets. This was on prescription by Respondent. Knight had been instructed by the Respondent on the occasion of prescribing Preludin on the question of how to utilize the Preludin tablets. At the time Respondent prescribed Preludin for patient Knight, he was unaware that the drug was an amphetamine or sympathomimetic amine drug. Respondent also discovered that Preludin prescriptions could not be refilled when a pharmacist contacted him in August of 1979 reference an effort by Knight to refill a prescription. Dr. Dunsford had reviewed the patient records related to Gladys Knight, particularly as it related to the prescription of Preludin. He identified that Preludin has been prescribed to assist obese people in weight control through the devise of suppressing the appetite of those patients. Because of a potential for abuse, Preludin is only prescribed for utilization over a period approximating a few weeks, per Dr. Dunsford. His testimony about Preludin, related to utilization, appropriate limits of its use, and potential for abuse is accepted. Dr. Dunsford felt that the Preludin had been over prescribed in the sense of amounts being too large on each prescription and over too long a period of time. Dr. Dunsford placed particular emphasis on the lack of wisdom in prescribing 100 tablets of Preludin on one occasion and felt that would be excessive and inappropriate. These opinions are accepted. Moreover, the opinion by Dr. Dunsford that the pattern of prescribing Preludin for Knight were not the actions of a reasonably prudent physician, under similar conditions and circumstances, is found to be correct. Dr. Ilano did not feel that the amount of Preludin was excessive nor did he feel that the actions of the Respondent constituted a failure to practice medicine with the care and skill that a reasonably prudent physician, under similar conditions and circumstances, would pursue. Dr. Ilano's opinion is not accepted. Nor is the opinion of Dr. Saylor related to the treatment of Mrs. Knight utilizing Preludin found to be compelling when he speaks favorably to treatment choices by the Respondent. JOHN BROUGHTON (Counts VIII, IX, X and XI) John Broughton was a patient of the Respondent in the time period August 13, 1979, through February 16, 1981. Records related to the treatment of Broughton are found as part of the Petitioner's Exhibit E admitted into evidence. During the treatment of Broughton, beginning on August 13, 1979, 40 Preludin, 75-milligram tablets were provided for weight control. Preludin, 75- milligrams was again prescribed for control on September 21, 1979, following examination by Respondent. On October 31, 1979, Dr. Bonzon saw Broughton and prescribed Preludin 75-milligram in the amount of 60 tablets related to weight control. On December 31, 1979, an additional 80 tablets of 75-milligrams Preludin was prescribed by Respondent for the benefit of Broughton. On March 13, 1980, 100, 75-milligram preludin tablets were given to Broughton on prescription issued by Respondent. On June 4, 1980, 50, 75-milligram Preludin tablets were prescribed by Respondent for Broughton. Respondent denied Broughton a request for Preludin upon an office visit on July 28, 1980, to see how the patient would react without the drug. On November 3, 1980, Preludin, 75-milligrams in the amount of 40 tablets was prescribed by Respondent for Broughton for weight control and a notation made that no further prescription would be written unless 40 days had transpired. On December 11, 1980, without examining the patient, Preludin was prescribed for an unidentified condition. The strength of the Preludin was 75-milligrams and 50 tablets were authorized by the prescription issued by Respondent for the benefit of Broughton. Other evidence in the hearing demonstrates that this Preludin was prescribed for weight control on that visit. During the course of the treatment, Broughton lost approximately 20 pounds in weight. In the interval of treatment, Broughton had requested Respondent to prescribe additional Preludin tablets and had been advised by Respondent that they would not be forthcoming based upon the fact that sufficient time had not transpired to have utilized one tablet per day on the previous prescription. In addition, the Preludin was not prescribed for Broughton if his blood pressure was too high upon examination by Dr. Bonzon. At the time Dr. Bonzon prescribed Preludin in November and December, 1980, as identified before, he was unaware that Preludin, an amphetamine or simpathomimetic amine drug, could not be prescribed for weight control after July 3, 1980. 1/ On August 13, 1979, Talwin was prescribed for Broughton by the Respondent upon an office visit. The explanation for this prescription says for "hip." In particular, it related to the provision of pain medication. Talwin, as with the case of Preludin, is a Chapter 893, Florida Statutes, controlled substance with addictive qualities. Talwin is, in effect, a pain medication. On September 21, 1979, a further prescription of Talwin was prescribed by Respondent for Broughton upon an office visit. This Talwin in 15-milligram strength, 40 tablets with opportunity for a single refill. No indication was made in the record as to the basis for prescribing this pain medication. Between August 13, 1979, and September 21, 1979, there is a notation in the patient records effective August 28, 1979, of a refill of Talwin in 50-milligram strength, 30 tablets and a further indication of Talwin being prescribed, 50- milligram strength, 30 tablets on September 13, 1979. On November 8, 1979, the patient record shows a refill of Talwin in the amount of 50 tablets. On November 16, 1979, the file establishes that the patient said he had been caught in the rain and his bottle got wet and that the Talwin turned to mush and a prescription was written in the amount of 50 Talwins to replenish Broughton. Broughton verified this story in the course of his testimony at hearing. The pills had not been destroyed but the Respondent did not know this at the time the prescription was written on November 16, 1979. The records reflect a notation on that date that no refills of Talwin should be given until November 28, 1979. On December 31, 1979, the patient was seen by Respondent for a problem he was experiencing with a hernia condition and a cough, congestion, and headaches. On that date, Talwin in, the 50-milligram strength, 50 tablets was prescribed. On the dates January 22, 1980; February 10, 1980; and February 28, 1980, patient records show prescription of Talwin in the 50-milligram strength, 50 tablets on each of those dates. The patient was seen by Dr. Bonzon on March 30, 1980, complaining of the hernia condition and a prescription was written for 50 Talwin, 50-milligram tablets. On June 4, 1980, the Respondent saw Broughton and prescribed 50 Talwin in 50-milligram strength. On July 28, 1980, Respondent saw Broughton and discussion was made of establishing surgery for hernia repair. Talwin was prescribed in a 50-milligram strength, 50 tablets with an indication of no refill, as established in the patient records. On August 25, 1980, an indication is made in the patient records that Talwin, 50-milligram strength in the amount of 40 tablets was prescribed for the patient. On October 10, 1980, patient records show that Talwin was refilled. On November 10, 1980, patient records reflect that a Pic N Save Drug Store had received a request for refill of Talwin in the amount of 40 tablets and this request was denied by the doctor's office based upon the fact that a refill had just been given on November 3, 1980. On November 20, 1980, the records reflect that the Pic N Save at Sandlewood was given a prescription of Talwin, 50-milligram strength in the amount of 40 tablets for benefit of Broughton. On December 8, 1980, the patient was seen by Respondent. It was noted in the record that Talwin in the strength of 50-milligrams, 20 tablets had been prescribed two days before. Other evidence does not clarify whether that prescription was indeed written. On December 19, 1980, the patient records reflect that Talwin in the strength of 50-milligrams, 50 tablets was prescribed. On January 9, 1981, the records reflect Talwin, 50-milligram strength, 40 tablets was prescribed. On January 19, 1981, the record reflects Talwin, 50-milligram strength, 40 tablets was prescribed. On February 2, 1981, a notation is given that the patient has injured his leg and had received a night appointment and has reported using all the Talwin due to intense pain. Further indication is that Talwin in the amount of 50-milligram strength, 10 tablets was prescribed. A second entry related to February 2, 1981, is made having to do with a visit in which Respondent examined Broughton. He found the leg on the right calf highly inflamed and two large hemotomas and that the patient was experiencing pain and for this condition, Talwin in the amount of 50-milligram strength, 50 tablets was prescribed. On February 11, 1981, a final notation indicates a refill of Talwin and the establishment of an appointment for the following day. That appointment was not kept. On February 16, 1981, the Talwin was ordered refilled. A notation was made at that time that the patient had not been keeping his appointments because of money owed and an expression of the importance to come in even if he could only pay a portion of the bill and a notation that the patient was using too much Talwin. All record notations are accepted as accurate depictions of events reported. Eventually, Broughton was picked up for criminal offenses related to controlled substances and was imprisoned. Unknown to Respondent, Broughton had given Talwin and Preludin which had been prescribed for him through Respondent to other persons. Following his release from incarceration, Respondent has refused to see Broughton. Although the records do not reflect the specific basis for prescribing Talwin in the questioned period, August 13, 1979, through February 16, 1981, other than the occasions of the hip and leg injury to his calf, it has been extrinsically established that Talwin was prescribed for pain related to a hernia condition, at times beginning December 31, 1979, and forward. There is other indication that the patient Broughton had sustained an injury to his coccyx and had some sacro coccygeal pain; however, it is unclear whether the Talwin was prescribed for that condition in the questioned period. Moreover, by May 20, 1980, Dr. Bonzon is expressing the opinion that physical examination of Broughton was negative regarding sacro coccygeal pain. The patient's records do indicate on March 11, 1977, complaints of Broughton with his tail bone or coccyx because of a fall in a Pantry Pride store in San Diego, California. On the subject of Broughton's involvement with drugs, in an interview held in November 1981, Respondent told John E. Danson, an investigator with the Department of Professional Regulation, that he thought Broughton was a drug addict because on one occasion, Broughton had offered him $50 to prescribe Dilaudid, a Schedule II controlled substance, at which time Broughton had been asked to leave Bonzon's office. Dr. Dunsford examined the records of treatment received by Broughton found in Petitioner's Exhibit E and gave the opinion that the amounts of Preludin and Talwin prescribed to Broughton in the time frame described were excessive and inappropriate. The prescription of those drugs over this period of time was not in the best interests of the patient according to Dr. Dunsford and not the actions of a reasonably prudent similar physician dealing with a patient under similar circumstances and conditions, on the subject of the skill and treatment afforded to this patient. As described by Dr. Dunsford, both Talwin and Preludin have addictive qualities. Dr. Dunsford did not feel that the pain the patient Broughton had experienced was sufficiently severe to warrant the number of Talwin tablets received. Continued response to the patient's request for more Talwin was in the words of Dr. Dunsford "bad." Dr. Dunsford also observed that the prescription of Preludin in November and December 1980, was not based upon any of the health conditions described in Section 458.331(1)(cc), Florida Statutes. The overall records of Dr. Bonzon related to the prescriptions of Talwin and Preludin, with particular emphasis on the December 11, 1980, prescription were deficient as it relates to a justification of continuing the regimen of prescribing these substances, according to Dr. Dunsford. The observations and opinions of Dr. Dunsford found in this paragraph are accepted. Dr. Ilano examined the records related to Broughton and did not find that Respondent's treatment was unacceptable. Likewise, Dr. Saylor did not find the treatment of Broughton to be unacceptable. The opinions by these doctors are not accepted. COUNTS XIV and XV Between July 1, 1980, and December 31, 1980, Respondent prescribed approximately 15,260 controlled substances constituted of Percodan, Percocet, Tuinal, Preludin, Tylox, Quaalude, Ritalin, Demerol, Merperganfortis, Biphetamine, Sopar, Eskatrol and Dilaudid. With the exception of these substances related to the patients Scheider, Knight, and Broughton, no notation has been made that these drugs were prescribed, dispensed or administered in excessive or inappropriate amounts i.e., the 15,000 number is not excessive and inappropriate "on its face," nor is this raw number an indication that Respondent has failed to practice medicine with a level of care, skill and treatment which is recognized by a reasonably prudent, similar physician as being acceptable under similar conditions and circumstances.
The Issue The issue is whether Petitioner is entitled to a permit as a prescription drug wholesale distributor.
Findings Of Fact On August 29, 2007, Petitioner filed with Respondent an application for a permit as a prescription drug wholesaler establishment (Application). Pursuant to a change in the law effective July 1, 2008, this permit is now for a prescription drug wholesale distributor. The Application lists Boris Rios as the sole owner of Petitioner and its president and manager. The Application lists Alexander Valdes as the next highest-ranking employee with a title of certified designated representative (CDR). The Application requires Petitioner to list all persons who meet the following descriptions of affiliates: a) "a director, officer, trustee, partner, or committee member of a permittee or applicant or a subsidiary or service corporation of the permittee or applicant"; b) "a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless of whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant"; c) "a person who has filed or is required to file a personal information statement pursuant to s. 499.012(4), F.S., or is required to be identified in an application for a permit or to renew a permit pursuant to s. 499.012(3), F.S."; d) "the five largest natural shareholders who own at least 5 percent of the permittee or applicant . . ."; and e) "shareholder[s] owning 5% or more of the applicant." In response to this item, the Application states that Mr. Rios meets the criteria set forth in paragraphs a) through e), and Mr. Valdes meets the criteria set forth in paragraph b). Attached to the Application are Personal Information Statements for Mr. Rios and Mr. Valdes. Mr. Rios's Personal Information Statement discloses his employment, from July 2003 to July 2007, as a "sales mgr" with Worldwide Medical Supplies and Pharmaceuticals, Inc. (Worldwide). His statement includes a resume that states he was a "sales executive" for Worldwide from July 2003 to February 2004, a "purchasing/deliver[ies] manager" for Worldwide from February 2004 to May 2005, and a "sales manager" for Worldwide from May 2005 to July 2007. As sales manager, Mr. Rios stated that he "[o]ver looked all sales transactions for all sales reps (7 man sales force). Buy establishing sales strategies and product promotions to help increase our sales and profit margins. And keeping sales force motivated and inspired by creating incentives to reach goals." Mr. Rios's attached resume shows that he had been a sales manager for another pharmaceutical manufacturer from January 2001 to July 2003. Mr. Rios's statement also answers in the negative a question asking whether he, "or a company for which you were an owner, officer, director, or manager, has been fined or disciplined by a regulatory agency in any state (including Florida) for any offense that would constitute a violation of Chapter 499, Florida Statutes?" However, his statement answers in the affirmative a question asking whether he, "or a company for which you were an owner, officer, director, or manager, ever held a permit issued under Chapter 499, Florida Statutes, in a different name than [Petitioner's name]?" However, on a mostly blank page entitled, Additional Information," Mr. Rios handwrote that he was employed by Worldwide from July 2003 to July 2007 as the sales manager of seven salespersons from May 2005 to July 2007, as the purchasing manager from February 2004 to May 2005, and as a sales representative from July 2003 to February 2004. Mr. Valdes's Personal Information Statement discloses his employment with Worldwide from 2003 to present as a "sales mgr" and "D Rep," meaning certified designated representative. Inserted in the Application is a letter dated May 30, 2008, from Mr. Valdes to Rebecca Burnett, an employee of Respondent, stating that he was "hereby submit[ting] my resignation from Worldwide . . . effective May 30, 2008 " Mr. Valdes's Personal Information Statement contains a long typewritten statement that says he was employed at Worldwide since 2003 in "various positions," starting as a sales person, then a sales manager, and finally a CDR, following his preparing for and passing the certification test. At about the same time, a newer Worldwide employee, Rick Nielsen, also took the CDR test, passed, and became a CDR for Worldwide, working a different shift from Mr. Valdes. Mr. Valdes stated that he often ordered Worldwide not to accept or to return a product due to product-safety issues, and he helped state inspectors in their investigations concerning these matters. However, on the Personal Information Statement itself, Mr. Valdes answered in the negative a question whether he or any company for which he had been a manager had been fined or disciplined by a regulatory agency. By letter dated September 8, 2008 (Denial Letter), Respondent advised Petitioner of its intent to deny the application. Among the reasons cited for denial are that Petitioner listed Mr. Valdes as its CDR. The Denial Letter states that, in Final Order Number 08-1216, Respondent found 37 violations of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes, and revoked the permit of Worldwide Medical Supplies and Pharmaceuticals, Inc. (Worldwide), to operate as a prescription drug wholesale distributor. According to the Denial Letter, Mr. Valdes was Worldwide's CDR from August 2005 to May 2008 and sales manager from April 2003 to May 2008; he is also the son of the president and owner of Worldwide, Miriam Gonzalez. The Denial Letter states that Mr. Valdes was listed on the Application as a key employee of Worldwide and did not submit to Respondent his resignation as Worldwide's CDR until May 30, 2008. The Denial Letter asserts that, on four occasions from July 18 to November 8, 2005, Mr. Valdes received and authenticated a pedigree that was not authenticated, so that Worldwide failed to keep the required records of prescription drug transactions. The Denial Letter states that, on six occasions between October 17 and 31, 2005, Mr. Valdes or another Worldwide employee falsely represented under Mr. Valdes's signature that a pedigree had been presented to Worldwide and authenticated by Mr. Valdes, but Worldwide had not received the complete and accurate pedigrees and had not maintained them. The Denial Letter states that receipt of the drugs without a complete or accurate pedigree caused the drugs to be deemed adulterated. The Denial Letter states that, on August 16 and September 23, 2004; and September 25, October 16, and October 27, 2006, Worldwide purchased a prescription drug from an unlicensed manufacturer or wholesaler. The letter states that this activity constituted the purchase of contraband in commerce and was detrimental to the public health. The Denial Letter asserts that Mr. Rios was an affiliated party of Worldwide at all material times. The Denial Letter states that Mr. Rios owns Petitioner and provides financial support and assistance to Petitioner, so he is an affiliate of Petitioner. The Denial Letter states that Respondent found that Petitioner was not entitled to licensure under Section 499.012(4)(d)9, Florida Statutes. The Denial Letter states that, pursuant to Section 499.012(10)(b), Florida Statutes, Respondent may deny an application if it finds that the managers, officers, or directors of the applicant or an affiliate of the applicant are incompetent or untrustworthy. Based on the facts set forth above, Respondent finds Mr. Valdes, an affiliate, incompetent or untrustworthy. The Denial Letter states that, pursuant to Section 499.012(10)(g), Florida Statutes, Respondent may deny an application if it finds that the applicant is affiliated, directly or indirectly through ownership, control or other business relations, with any person or persons whose business operations are or have been detrimental to the public health. Based on the facts set forth above, Respondent finds Mr. Valdes is an affiliate whose prior business operations are or have been detrimental to the public health The Denial Letter states that, pursuant to Section 499.012(10)(r), Florida Statutes, Respondent may deny an application if it finds that the applicant or any affiliate has failed to comply with the requirements for manufacturing or distributing prescription drugs under Chapter 499, Florida Statutes. The Denial Letter asserts that Section 499.003(3), Florida Statutes, defines an affiliate to be a person who has filed or is required to file a personal information statement or a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant. The Denial Letter states that Respondent finds that Mr. Valdes, while employed at Worldwide, failed to comply with the laws related to the distribution of prescription drugs while having a duty to be actively involved in and aware of the actual daily operation of the company. The Denial Letter states that Mr. Valdes had a duty to be actively involved in and aware of the actual daily operations of the company. The Denial Letter states that, while Mr. Valdes was CDR for Worldwide, the company purchased prescription drugs from an unauthorized source, in violation of Section 499.005(16), Florida Statutes; failed to maintain records of prescription drug distributions as required by Florida Administrative Code Rule 64F-12.012(6) and (10), in violation of Section 499.005(18), Florida Statutes; accepted or maintained incomplete or nonexistent pedigrees and sold drugs to unlicensed persons, thus violating the adulterated-drug provisions of Section 499.005(1), (2), and (4), Florida Statutes. The Denial Letter states that, pursuant to Section 499.012(10)(m), Florida Statutes, Respondent may deny an application if the applicant or affiliate receives, directly or indirectly, financial support and assistance from a person who was an affiliate of a permittee whose permit was subject to discipline or suspended or revoked. The Denial Letter states that Petitioner receives financial support and assistance from Mr. Rios, who was an affiliate of Worldwide and is an affiliate of Petitioner. The Denial Letter states that, at all material times, Worldwide engaged in business operations that were detrimental to the public health by purchasing adulterated prescription drugs and by adulterating prescription drugs. Worldwide filed a renewal application on May 17, 2007, for a renewal term from July 1, 2007, to June 30, 2008. The renewal application lists Ms. Gonzalez as the company's sole shareholder and manager. The only persons listed among the next four highest-ranking employees are Mr. Valdes, who is listed as the CDR and "Longistic [sic] Manager" and Mr. Rios, who is listed as "Purch/Sales Director." Each man is reported as "a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee " Sometime in 2007, Respondent commenced a disciplinary proceeding against Worldwide. In its Second Amended Administrative Complaint dated August 24, 2007, Respondent alleged that Worldwide violated Sections 499.001 through 499.081, Florida Statutes, based on documents that it had prepared during 2004-06. A formal hearing took place on February 11 and 12, 2008, and Administrative Law Judge Patricia M. Hart entered a Recommended Order on May 1, 2008, which was adopted in its entirety by Final Order entered October 12, 2008 (FO). The Final Order finds Worldwide guilty of 37 violations of Chapter 499, Florida Statutes, imposes administrative fines of $185,000, and revokes Worldwide's permit as a Prescription Drug Wholesaler. The Final Order (FO) was never appealed. The FO finds multiple acts and omissions attributable to Worldwide in the handling of prescription drugs shipped to it or, in some cases, purchased by it. Concerning incomplete and thus fraudulent authentications of pedigree papers, these acts and omissions ranged from February to April, June to September, and December 2004; and April to November 2005. Only seven of these violations occurred in 2004; the rest were in 2005. Concerning purchases from unlawful persons, of which there were a dozen, these acts and omissions took place in August 2004, December 2004, June 2005 (two), April 2006, September 2006 (two purchases from Kuehne & Nagel) October 2006 (four purchases from Kuehne & Nagel), and March 2007. Mr. Valdes is named in connection with six of the unlawful transactions. For October 2005 (except for one transaction in November 2005, as indicated), the FO found a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 35 6GM vials of Carimune was incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of seven 10ML units of Baygam as incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 15 12GM vials of Carimune as incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 100 2ML units of Baygam was incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 100 units of Gammar P as incomplete and thus "false" (November 2005), and one pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of one 2ML unit of Baygam SDV and three 10CP units of Tamiflu 75MG was incomplete and thus "fraudulent." In his responses to requests for admission in this case, Mr. Valdes admits that he received and authenticated the pedigree paper, on October 10, 2005, for Carimune; the pedigree paper, on October 18, 2005, for Baygam; the pedigree paper, on July 18, 2005, for Baygam; and the pedigree paper, on November 8, 2005, for Gammar P. Worldwide never employed many employees, perhaps never more than 8-10. Ms. Gonzalez owned the company, but reduced her interest to 51 percent from February 2004 to December 31, 2006, during which period Mr. Nielsen owned 49 percent. However, Mr. Nielsen terminated his employment with Worldwide on December 31, 2006, and evidently relinquished his interest in the company at that time. Upon initial employment, Mr. Nielsen occupied a position in which he supervised the purchasing manager, Mr. Rios, who, even though called a manager, supervised no one. At that time, Mr. Rios was lower-ranking than Ms. Gonzalez, Mr. Nielsen, Mr. Valdes, and possibly another employee. At some point, Mr. Nielsen was designated a CDR for Worldwide, and he remained a CDR for Worldwide until he left employment with the company. Prior to that, Mr. Gonzalez had served as the CDR for Worldwide. Mr. Valdes also served as a CDR for Worldwide. Based on his responses to requests for admission, Mr. Valdes started as CDR for Worldwide in August 2005, so he and Mr. Nielsen were both CDRs for Worldwide at the same time. Mr. Valdes served until the end of July or early August 2006, when, dissatisfied with his employment situation, he terminated his employment. Mr. Valdes did not return until early January 2007 when his mother needed him to serve as CDR again because Mr. Nielsen had left, and no one remaining with Worldwide could pass the test to become a CDR. Mr. Valdes produced testimonials from various persons, such as a former drug agent supervisor of Respondent and current investigators of Medicaid fraud, who commend him for assisting in combating fraud in the wholesale pharmaceutical industry. However, at the hearing, Mr. Valdes never explained how he was not at fault or responsible for the violations in which the paperwork bore his stamp or other violations taking place, particularly while he was CDR. Mr. Valdes was sales manager during the 2004 violations and a CDR during all of the bad-pedigree transactions from August to December 2005, as well as one bad-purchase transaction in April 2006. He had sizable responsibilities during a timeframe that many violations were taking place at Worldwide, and, despite the three commendations and candid demeanor at the hearing, does not appear to have done a good job discharging these important duties. As confirmed by Ms. Gonzalez, Mr. Rios was the sales manager from May 2005 to July 2007, and he had supervisory authority over a sales staff that, at most, numbered seven persons. Mr. Rios could hire and fire salespersons, but he had no contact with the prescription drugs. From February 2004 to May 2005, Mr. Rios was purchasing manager, but worked under the supervision of Mr. Nielsen and lacked any managerial duties.
Recommendation It is RECOMMENDED that the Department of Health enter a final order denying the application for a permit as a prescription drug wholesale distributor until Mr. Rios substitutes a qualified CDR for Mr. Valdes--a condition that the Department of Health should allow Mr. Valdes a reasonable time to satisfy. If Mr. Rios cannot submit the name of a qualified CDR within such time, the final order should provide for the denial of the application without prejudice to refiling at a later date with a qualified CDR. DONE AND ENTERED this 9th day of March, 2009, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of March, 2009. COPIES FURNISHED: Alexander Valdes, Qualified Representative 14052 Southwest 80th Street Miami, Florida 33183 Gary L. Asbell, Esquire Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 Rebecca Poston, R.Ph., Executive Director Drugs, Devices, and Cosmetics Program Department of Health 4052 Bald Cypress Way, BIN C04 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701
Findings Of Fact The Respondent Herman Ginsberg is a licensed pharmacist having been issued license number 0008019. The last known address of the Respondent is 775 Northeast 164th Street, North Miami Beach, Florida 33162. At all times material to this proceeding, the Respondent was the managing pharmacist at Jaffe Pharmacy, also known as Jaffe Discount Drugs, located at 737 Northeast 167th Street, North Miami Beach, Florida 33162. On or about November 26, 1980, the Respondent Ginsberg directed a clerk at the pharmacy, Lorraine Gronfine to remove nine (9) prescriptions from the class II prescription records and place them under a desk blotter. The scripts were pulled by Ms. Gronfine prior to a drug inspection by the authorities. According to the Respondent Ginsberg, he was ordered by the manager of the pharmacy, Ed Terry, to pull the prescriptions in order to inflate an insurance claim resulting from a burglary which occurred in September 1980. The Respondent complied with Mr. Terry's request and reported that drugs were stolen which were not in fact stolen in order to inflate an insurance claim to approximately $7,000. The prescriptions were discovered under the blotter by Irving Losee, another pharmacist employed by Jaffe, who turned them over to Graymark Security. Graymark personnel questioned both the Respondent and Ms. Gronfine about the prescriptions and both gave statements to Graymark concerning how the prescriptions came to be placed under the blotter. Many, although not all, of the prescriptions found by Losee were altered. No testimony expert or otherwise was introduced to prove that the Respondent altered the prescriptions in question. As noted by counsel for Respondent, no direct evidence was introduced to rebut the Respondent's sworn denial that he personally altered the prescriptions. In the normal course of business at Jaffee Pharmacy, a patient log was kept for all prescriptions filled on a daily basis. It is undisputed by the parties that the patient log, which was kept by the Respondent, was not altered and reflected the actual number of pills dispensed by the pharmacy. In order to divert classified drugs for personal profit, it is logical to assume that the Respondent would have altered the patient logs along with the prescriptions to consistently cover the amount of classified drugs ordered from pharmaceutical companies and placed on record with the Drug Enforcement Administration. Indeed, the failure to alter the daily patient logs to be consistent with the altered prescriptions was one of the ways that the problem with the altered prescriptions was uncovered. Although Mr. Terry examined the patient logs nightly to grade his employees on their sales of drugs, this would not have necessarily stopped the logs from being changed to conform to the altered prescriptions. The Respondent or anyone with access to the patient logs, could have altered the logs after the nightly review and conform the logs and prescriptions without arousing undue suspicion. No testimony was presented concerning this point other than that the logs did not go to accounting and were presented to Mr. Terry for his review. If Mr. Terry kept the logs and the Respondent had no further access to them, the Petitioner's theory concerning the alterations would be more plausible; however, the record failed to show that the Respondent lacked the ability to alter the logs subsequent to Mr. Terry's review. Each prescription placed into evidence and filled by the Respondent is marked as being "verified by the issuing physician." The Respondent has admitted that some of these prescriptions were not verified and that the certifications were erroneous. The Respondent admitted that a person named Fred Sessler, who was associated with a stress or obesity clinic, was permitted to pick up controlled drugs for the clinic without a prescription. Mr. Sessler was apparently permitted this privilege because the Respondent knew that one of the clinic physicians would eventually furnish a prescription. Additionally, the Respondent has admitted that in connection with the Sessler transactions, he failed to immediately record all the information required in order to dispense oral prescriptions and failed to notify the Drug Enforcement Administration that he was emergency dispensing via telephone. While acting as managing pharmacist at Jaffee, the Respondent ordered and distributed excessive quantities of a Schedule II drug. (See Petitioner's Exhibit 26 and Respondent's Exhibit 1.)
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the license of the Respondent Herman Ginsberg be suspended for two (2) years and that he be placed on probation for three (3) years thereafter, subject to attending appropriate continuing education classes and working under the direct supervision of a pharmacist approved by the Board. DONE and ENTERED this 27th day of January, 1983, in Tallahassee, Florida. SHARYN L. SMITH Hearing Officer Division of Administrative Hearings 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 January, 1983.
Findings Of Fact Respondent Alden Craig Schewe is a 50-year-old, board certified surgeon who practiced in Pittsfield, Illinois, before relocating to Plantation Key, Florida, in 1973, where he joined the staff of what is now Mariners Hospital. He was originally licensed to practice in Florida in 1970, and the parties stipulated that he was licensed to practice medicine in Florida at all pertinent times. MISFORTUNES Respondent had a series of accidents, beginning in 1976, that left him able to perform surgery, but which nevertheless caused painful injuries. At hearing Dr. Schewe recounted a "number of misfortunes." The first was an electrical shock from an auxiliary generator at his home which knocked him unconscious. He hurt his back as he fell. Later the same year, a 23-foot boat fell on him when a davit cable parted, injuring his left shoulder and his back. He was not hospitalized on either occasion, but he began taking pain killers. Some time later Dr. Schewe was at the controls of a helicopter which plunged into the water shortly after taking off. He swam to shore unassisted. Still later he broke his foot when an engine was dropped on it. Finally, in 1978, he stepped through a rotten dock and injured his right shoulder. PILLS PRESCRIBED Demerol or meperidine, T: Vol. I, p. 28, Vol II, p. 145, is a synthetic narcotic, an analgesic for relief of pain. Vol. I, p. 11. Percodan and Tylox are trade names for compounds that include a Class II narcotic. T: Vol. I, p. 33. Vol II, p. 173. They are very similar. The only difference between them may be that Tylox contains Tylenol, while Percodan contains aspirin. They are both "morphine derivatives. They contain an isomer of codeine called Oxycodone and will create a positive finding in the urine in the morphine or codeine screen." Vol. I, p. 12. These drugs are prescribed as pain relievers, and are occasionally used in weaning a heroin addict from heroin. T: Vol. I, p. 35. On January 29, 1976, Dr. Schewe wrote a prescription for 100 Percodan tablets for himself for use "as directed." He wrote other prescriptions for 100 Percodan tablets for himself for use "as directed" on February 16, 1976, and March 16, 1976. On April 1, 1976, he wrote himself another prescription for 100 Percodan tablets. Dr. Schewe wrote additional prescriptions for 100 Percodan Tablets for himself for use "as directed" on April 22, 1976, on May 20, 1976, on June 10, 1976, on June 25, 1976, on July 19, 1976, on August 3, 1976, on August 30, 1976, on September 17, 1976, on October 7, 1976, on October 30, 1976, on November 15, 1976, on November 29, 1976, and on December 17, 1976. In all, Dr. Schewe prescribed 1700 Percodan tablets for himself in 1976. At various times throughout 1976, respondent also wrote 15 prescriptions for himself for Demerol or meperidine. Three of these were marked "as directed," and three were marked "office use" or had the word "office" on the prescription form elsewhere than in the address blank. The following year saw Dr. Schewe prescribe an additional 1700 Percodan tablets for himself. He wrote 100- tablet Percodan prescriptions for himself for use "as directed" on January 3, 1977, on January 14, 1977, on February 16, 1977, on March 17, 1977, on May 16, 1977, on June 30, 1977, on July 12, 1977, on July 28, 1977, on October 31, 1977, and on November 14, 1977. He also wrote 50- tablet Percodan prescriptions for himself for use "as directed" on April 27, 1977, on May 26, 1977, and on October 13, 1977. He wrote a prescription for himself for 50 Percodan tablets on May 11, 1977, on which he made the notation "office stock." "Office stock" was also written on prescriptions respondent wrote for himself on June 4, 1977, on June 13, 1977, on August 9, 1977, on August 26, 1977, and on September 1, 1977, each for 100 tablets. At various times during 1977, respondent also wrote 10 prescriptions for himself for Demerol or meperidine. Three of these prescriptions had the notation "as directed", four had the notation "office stock" and one read "for med bag." In 1977, DEA agents came to Mariners' Hospital to investigate, and the medical staff of the hospital met with respondent in or about December of 1977. He was asked why he had prescribed so many controlled substances for himself, and was advised that it was against the law to write such prescriptions for himself. On March 7, 1978, on April 24, 1978, in May of 1978, in June of 1978 and on two other occasions in 1978, Dr. Halvor Leopoldo Franco wrote prescriptions for respondent for a total of 550 Percodan pills, after respondent told him that "he needed them for his chronic pain in his back or in his right shoulder, for his bursitis." Vol. II, p. 40. Dr. Franco is the anesthesiologist who regularly worked with respondent in surgery. He kept no medical records on Dr. Schewe because Dr. Schewe was not "an official patient of [his]." (Vol. II, p. 35) During 1979, Dr. Schewe wrote Percodan prescriptions for himself and for his second wife, Judy. For himself he prescribed 100 tablets of Percodan on August 12, 1979, 100 tablets of Percodan on September 24, 1979, and 50 tablets of Percodan on October 24, 1979, all for use "as directed." Respondent prescribed 50 Percodan tablets for Mrs. Schewe on April 16, 1979, another 50 on June 16, 1979, and another 50 on July 18, 1979. Dr. Halvor Franco prescribed Percodan tablets for respondent in 1979. On June 26, 1979, and again on July 21, 1979, Dr. Franco prescribed 100 Percodan tablets for respondent as needed for bursitis of the right shoulder. During the following year, Dr. Franco again prescribed Percodan tablets for respondent. On April 24, 1980, Dr. Franco wrote a 100-tablet prescription for Dr. Schewe for "acute pain in rt shoulder." On February 12, 1980, on August 6, 1980, and on November 21, 1980, Dr. Franco prescribed Tylox tablets for respondent Each prescription was for 100 tablets. The April and August prescriptions were ostensibly for "lumbar pain." On December 1, 1980, Dr. Ross prescribed 100 Tylox tablets for respondent. At various times during 1980, Dr. Schewe wrote Percodan and Tylox prescriptions for his wife. PILLS INGESTED All of the foregoing prescriptions were filled by the Mariners Hospital pharmacy. Respondent took almost all of these pills. He may have given some away to indigent patients, as he testified, but the nurse who began working for him on June 24, 1974, and worked in the office he shared with three other physicians for three and a half years testified that she could not remember respondent ever dispensing Percodan. The Percodan and Demerol in the office were not obtained pursuant to Dr. Schewe's prescriptions, in any event. When the Percodan supply was replenished, moreover, it was in batches of "perhaps twenty-four..." He might have given some Demerol to the son of a business associate who was addicted to cocaine or heroin. There was some testimony to that effect. But, by and large, respondent himself took the pills prescribed for him by himself and others, including the Percodan he prescribed for himself after July 1, 1979. The evidence was circumstantial but it was overwhelming. Mrs. Schewe took some of the pills respondent prescribed for her. She was ill and in pain for some time. But she did not like the side effects of Tylox and told her physician so, at the time. Respondent took some of the Tylox pills he prescribed for his wife. She saw him do it. In fact, even though she saw him take these pills several times, she never saw him take Percodan or Tylox that he prescribed for himself. Vol. II, pp. 137 and 140. Respondent never told Dr. Franco that he was getting Percodan or Tylox elsewhere when he made his repeated requests for prescriptions. Once, when he asked Dr. Ross for Tylox and Dr. Ross prescribed ten tablets, Dr. Schewe "refused because of the numbers, and [Dr. Ross] increased that number to 100 at his request." T: Vol. I, p. 17. PATIENTS' SAFETY Dolores A. Morgan, a board-certified family practitioner with considerable experience and expertise in treating physicians with chemical dependency problems, testified that a functional addict is one who seems to function normally so long as he maintains a certain blood level of an addictive substance, such as oxycodone. When respondent voluntarily submitted to an evaluation by her, no oxycodone was detected in his system, but Dr. Morgan was nevertheless persuaded, principally because of what she took to be his evasiveness, that Dr. Schewe was an "impaired physician." Sanford Jacobson, a psychiatrist, disagreed. More than one witness recalled Dr. Franco's expressing concern because Dr. Schewe's hands shook while he was operating. At hearing, however, Dr. Franco denied that he had ever seen respondent's hands shake or that he had ever told anybody that he had. Because the only testimony of shaking hands was hearsay to which timely objection was made, respondent's motion to strike was granted and there is no evidence to support a finding that Dr. Schewe's hands shook in surgery. All the competent evidence was the other way. Fellow physicians and operating room nurses all said that they had never seen any indication that Dr. Schewe's abilities as a surgeon were in any way diminished. He performed surgery at something like the rate of 250 operations a year during the period in question, and at all hours of the day and night. There was no showing that respondent has ever made any error in the practice of medicine for any reason, on any patient other than himself.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner suspend respondent's license for six (6) months and place him on probation thereafter for five (5) years. DONE and ENTERED this 14th day of September, 1983, in Tallahassee, Florida. ROBERT T. BENTON, II 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 14th day of September, 1983. COPIES FURNISHED: Joel S. Fass, Esquire 626 N.E. 124th Street North Miami, Florida 33161 Alfred K. Frigola, Esquire Post Office Box 177 Marathon, Florida 33050 Ellis S. Rubin, Esquire and S. Richard Kaplan, Esquire 265 N.E. 26th Terrace Miami, Florida 33137 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Deborah J. Miller, Esquire Department of Professional Regulation Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Department of Professional Regulation Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION, Petitioner, vs. CASE NO. 81-2362 ALDEN CRAIG SCHEWE, M.D. License No. 18477 Respondent. /
The Issue Whether or not the Respondent's license to practice pharmacy should be suspended or revoked pursuant to Section 465.101(1)(e) and 893.13(3)(a) 1 , Florida Statutes. The Hearing Officer explained to the Respondent the nature of the hearing and his rights under the Administrative Procedure Act, including the right to be represented by counsel at his own expense, if he so desires. It was also explained to the Respondent that he could testify in his own behalf, but that he was not required to do so and that if he did so testify, he could be cross- examined by counsel for Petitioner. Respondent acknowledged understanding of these rights and elected not to testify in his own behalf during the course of the hearing; however, he did participate in the cross-examination of Petitioner's witnesses and made a closing statement in which he denied the allegations against him.
Findings Of Fact During the period in question, i.e., April, 1975, Mr. Stanley Margolis was the manager of Gray Drug Store, No. 365, located at 12852 Biscayne Boulevard, North Miami, Florida. He and the Respondent are the only licensed pharmacists employed at that store (testimony of Mr. Margolis). "Eskatrol" is a trade name for a drug which is bottled and sold in capsules called "spansules". It contains dextro- amphetaminesulfate and acts as a stimulant on the central nervous system. It is used primarily as an appetite suppressant, although it also is sometimes prescribed in an emergency situation for narcolepsy to keep a person awake. It is a Schedule II drug under the Florida Comprehensive Drug Abuse and Prevention Act, Chapter 893, F.S. because it is an amphetamine (Testimony of Mr. Bell, Dr. Danoff). The procedure employed by Gray Drug Store to order Schedule 11 drugs was for Mr. Margolis to write a narcotic order form which he sent to a wholesaler who would then fill the order and send back an invoice with the narcotics in a box that was signed for by one of the pharmacists. At that time, the drugs would be counted, checked off and written down. Either Margolis or Respondent was on duty at the drug store at all times when it was open for business and Respondent could sign for such deliveries if Margolis was not then present. On approximately April 10 or 11, the store had run out of narcotics order forms and had exhausted its supply of several drugs, including ones with the trade name of Eskatrol. However, on Saturday, April 12, a prior order for ten bottles of Eskatrol, each bottle containing 50 capsules or "spansules" as they were termed, were received at the store. Respondent was on duty at this time and signed for the shipment. It was his responsibility to check the numbers of bottles received, enter the amount in a narcotics journal and place the drugs in a locked cabinet. On Monday, April 14, Margolis came on duty, reviewed the receipt of Eskatrol and determined that the shipment was correct based upon his examination of the invoice. He did not check the drug cabinet at this time. About 6:00 or 7:00 p.m. he received a prescription for 50 sparsules of Eskatrol. At this time, he noticed that there were only eight bottles in the cabinet when there should have been ten. He thereupon checked his prescription files for narcotic and other drugs and found no prescription to cover the two missing bottles of Eskatrol ewhich would have contained a total of 100 spansules. The store maintained a daily prescription log which indicated the prescriptions filled and a "waiting" file which was used to hold prescriptions for emergency drugs which had been issued pursuant to a telephonic request of a physician while waiting for the written prescription from the physician to arrive at the store. Mr. Margolis, on the morning of April 16, asked Respondent about the discrepancy. The Respondent told him that the wholesaler had been" short two bottles." Margolis was disturbed about this alleged shortage and therefore called the district manager of Gray Drugs, a Mr. Krake. On the morning of April 17, Margolis found a telephoned prescription form for 50, spansules of Estatrol in the "waiting" file (Petitioner's Exhibit 1). The Respondent told him that it had been called in and that he was waiting for the prescription. He said that he had written the prescription. Margolis identified the handwriting as being that of the Respondent. The prescription was in the name of Ron Richards and showed an address of "2405 Northeast 135". It did not bear a street, avenue, or city designation. There was no date entered in the "Date" space on the form, but the figures "4/14" appeared on the "RX" portion of the form. This portion also bore the handwritten number 221030, and showed the figures "825". The doctor's name was Danoff and shown with address of 4100 South Hospital at Plantation. The number 5870448 also appeared on the prescription form and the words "will mail". Mr. Margolis then reviewed what had been entered on Sunday in the prescription log book and discovered that prescription number 221030 showed a patient named Kasen and a price of $1.95 for the prescription (Petitioner's Exhibit 2) . The practice of the pharmacy had been to use a numbering machine which would stamp the prescription and the patient's receipt with the prescription number. Although 99 percent of the prescriptions are marked with the numbered stamp, occasionally there can be some mistake if the machine jumps, and the same number can only be stamped two times by the machine. On April 14, while Mr. Margolis was checking the non-narcotic prescription files, he had seen a prescription numbered 221030 for 15 Actifed tablets, prescribed by a Dr. Wrench for a patient named Kasen. The retail price of 15 Actifed tablets is $1.95. His log book also reflected that the next number in sequence, prescription no. 221031, was also prescribed by Dr. Wrench for patient Kasen for Keflex (Petitioner's Exhibit 3). Both of these prescriptions were entered on the log for April 13th. Margolis does not know what happened to the other prescription bearing the number 221030; he saw it last on the night of April 15 (testimony of Mr. Margolis; Petitioner's Exhibits 1-3). Dr. Sherwood Danoff, a licensed physician who practices at Plantation, Florida, specializes in dermatology. He is not familiar with the name of Ron Richards and did not call the Gray Drug Store of North Miami, Florida, on April 13, 1975, to order Eskatrol for that individual. He had never written a prescription for Eskatrol, which is a combination of an amphetamine and a barbituate used in diet control as an appetite suppressant. He did not receive a phone call on April 13 from the Gray Drug Store and has never spoken on the phone to anyone representing himself to be the Respondent Mark Gorsky. The normal dosage of Eskatrol is one or two capsules a day and, although he has prescribed Schedule II drugs on an emergency basis over the phone, he would never issue a prescription for a dosage that would cover more than a 10-day period. An emergency prescription by telephone is usually given only for the period until the patient can get in to see the doctor. This is known as an oral prescription and the doctor must follow this up with a written prescription within 72 hours. Although Petitioner's Exhibit 1 reflects Dr. Danoff's phone number, he did not phone in the prescription (testimony of Dr. Danoff). On April 17, Mr. William W. Smith, the regional manager of Professional Services for Gray Drug Stores, Mr. Anthony Difulio, the Director of Loss Prevention for the drug Store chain for Florida, and Mr. Vernon K. Bell, an agent for the Florida Board of Pharmacy, met at the Gray Drug Store in North Miami to look into the discrepancy reported by Mr. Margolis. Mr. Smith made an inspection of the books and records of the store and discovered that certain narcotic drugs were missing, including two bottles of Eskatrol. He checked with Dr. Danoff's nurse and Gulf Company, the wholesaler of Eskatrol. He tried to find the address of Ron Richards, as shown on the prescription in an incomplete form, but any projection of the address by avenues or streets would place it in Biscayne Bay or the ocean. Mr. Smith, together with Mr. Difulio, Mr. Bell, and Mr. Krake, went into a back room of the drug store to discuss the situation and later asked the Respondent to join them. Neither Mr. Difulio nor Mr. Bell arc law enforcement officers and do not have the power to take a person into custody other than that effected under an ordinary citizen's powers. During this period, not all of the above-mentioned individuals remained in the room during the entire period of approximately an hour or an hour and a half. Mr. Gorsky left the room on two occasions. Prior to questioning the Respondent, Mr. Bell advised him that he did not have to answer any questions, that he had a right to remain silent and a right to counsel. He did not threaten him or offer him any inducements to answer questions. After this warning, Respondent decided not to take the polygraph or make a written statement, but he did make oral statements. At no time was Respondent told he was under arrest. Mr. Bell asked Respondent if he could explain or know anything about the shortage of Eskatrol. The Respondent stated that he had received a call from Dr. Danoff on Sunday, April 13, concerning the prescription and that he called the doctor back to make sure that it was authentic; that he had placed the `number at the right bottom of the prescription and in his mind it was legitimate. When asked about the existence of Ron Richards, Respondent told Bell that Richards had been in the store several times. Respondent admitted to Bell that he had written the prescription (Petitioner's Exhibit l) and that it was his handwriting. There is a certain conflict in what Respondent stated at this meeting in view of the fact that Mr. Difulio testified that Respondent had said a customer had come into the store on April 13 and said that a doctor wanted him to have Eskatrol; that he had called the doctor and verified the prescription. Difulio did not recall if Respondent had stated that he had first had a call from the doctor, although he testified that Respondent said that he had prepared the prescription and filled it for Richards. When shown by Difulio that the cash register tapes for April 13 did not reflect an entry of $8.25, and Respondent was asked for an explanation, he stated that he had probably "got taken" by believing the telephone number he called was that of the doctor. In addition, Respondent told Difulio that after filling the prescription, he became scared and put a number on it from another patient and, when asked by Difulio what had happened to it, Respondent stated that he had torn it up and destroyed it. Difulio did not recall Respondent telling Mr. Bell about Dr. Danoff calling Respondent concerning the prescription. However, Respondent made several different statements during the course of his interrogation while various of the parties to the meeting went in and out of the room (testimony of Mr. Smith, Mr. Difulio, Mr. Bell).
