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BOARD OF MEDICAL EXAMINERS vs. MANUEL P. VILLAFLOR, 86-003256 (1986)
Division of Administrative Hearings, Florida Number: 86-003256 Latest Update: Feb. 18, 1988

The Issue Whether petitioner should take disciplinary action against respondent for the reasons alleged in the administrative complaint?

Findings Of Fact At all pertinent times, respondent Manuel P. Villaflor, M.D., held a Florida license as a physician, No. ME 0020072. He practices in Daytona Beach, where he has an office on Ridgewood Avenue. UNTIMELY DEATH K.D., a white male, was pronounced dead at 3:59 P.M. on October 19, 1985, a few days shy of his 34th birthday. The autopsy disclosed superficial abrasions, acute blunt trauma to K.D.'s face, scalp and right hand, and acute, diffuse subdural hemorrhage. A paper bag full of prescriptidn medicine containers accompanied the body to the autopsy. Apparently because the labels indicated that Dr. Villaflor had written pain killing prescriptions for K.D., the medical examiner's office notified DPR. Some four months later, analysis of samples of K.D.'s blood and urine revealed that codeine, oxycodone, amitriptyline, also known as Elavil, nortriptyline, also known as Pamelor, and chlordiazepoxide, also known as Librium, had been present in the corpse in quantities "beyond the reference range for therapeutic use." Botting deposition, p. 6. The pathologist amended his initial conclusion that head injuries resulting from "multi-focal blunt trauma," id., p. 7, had caused R.D.'s death, by adding "multiple drug intoxication," id., as another cause of death. As far as the record shows, Dr. Villaflor never prescribed Elavil, Pamelor, Librium or their chemical equivalents for K.D. An osteopath whom K.D. saw toward the end of his life prescribed at least two of these medications, as well as medicine containing oxycodone. CONTROLLED SUBSTANCES UNCONTROLLED On November 15, 1985, Diane Rabideau, an investigator for DPR, called on Dr. Villaflor at his office. He was polite and cooperative. Ms. Rabideau had some difficulty understanding him; he is not a native English speaker, and he had recently suffered a stroke. But she understood well enough Dr. Villaflor's assertions that he did not believe K.D. to have been addicted to any drugs, and that he had not over-prescribed any medicine. Ms. Rabideau inspected the controlled substances kept in Dr. Villaflor's office. She found Tenuate Dospan, Restoril, Darvocet, Valium, Tylenol No. 4, Fiorinal No. 3, Xanax, Vicodin, Tylenol with codeine elixir, Dalmane, Anexsia, Centrax, "Tussend Ex. 1/2 oz.," Limbitrol, Equagesic, Phrenilin with codeine, Novahistine, Naldecon, Ativan, Nucofed, and "P.V. Tussin." When she saw them, they were not under lock and key. No inventory records reflected what was on hand and what had been dispensed. The parties stipulated that Dr. Villaflor "failed to maintain records of the[se] schedule controlled substances . . . as required by Section 893.07, Florida Statutes"; and that he "failed to keep the[se] drugs . . . under lock and key as required by 21 C.F.R. Section 1301.72." When Ms. Rabideau pointed out these omissions, Dr. Villaflor and his wife, who works with him in the office, said they would comply in the future. Mrs. Villaflor said she had not known of these requirements. A subsequent inspection by a DPR investigation found Dr. Villaflor in full compliance with reporting requirements governing controlled substances. K.D.'s PAIN On July 8, 1981, Dr. Villaflor saw K.D., apparently for the first time, at the Halifax Hospital Medical Center emergency room, and admitted him to the hospital. K.D. had sustained an electrical shock when he struck a high voltage power line with an aluminum ladder, as he was hurrying for shelter from a sudden rain. He lost consciousness "surrounded by a bluish flame." Petitioner's Exhibit No. 12. The elecricity burned his feet and made his lower legs tender, as well. Discharged from the hospital, he visited Dr. Villaflor's office on July 15, 1981. In these proceedings, DPR does not question Dr. Villaflor's prescription of Percocet, a combination of Tylenol and oxycodone, for pain on that visit. As a teenager, K.D. had broken his collar bone in falls from motorcycles on two separate occasions. One accident involved a ride over a waterfall. When he was 2l years old, he "was smashed between a construction vehicle and a bulldozer," Petitioner's Exhibit No. 12, suffering "a severe crushing injury to his chest." Some ten years later he "still ha[d] very mobile ribs secondary to this injury," and persistent pain in his back and legs. In November of 1981, Dr. Kolin, a psychiatrist in Orlando, admitted K.D. to Orlando Regional Medical Center. A myelogram "revealed a mild L5 radicular lesion on the left, consistent with chronic myofascial pain and left L5 radiculitis." Petitioner's Exhibit No. 11. During this hospital stay, K.D.'s "narcotic medications were tapered and discontinued." Id. Dr. Villaflor sent copies of his records to Dr. Kolin, to whom Dr. Gillespie in Nashua, New Hampshire, had referred K.D. Apparently Dr. Villaflor never asked and Dr. Kolin never volunteered to forward Dr. Kolin's records to Dr. Villaflor. Gary G. Parsons, a vocation rehabilitation counselor, met K.D. on February 8, 1982. After K.D. made a perfect score on an aptitude test, a state agency subsidized his vocational training at the American Computer Institute. When K.D.'s training there concluded on January 4, 1983, Mr. Parsons tried to assist him in obtaining employment, but eventually concluded that K.D. could not hold a job because "his pain, and his limitation was greater than" (T. 283) Mr. Parsons had originally realized. K.D.'s pain or his physical condition "was primary in his conversation almost every time" (T. 283-4) he and Mr. Parsons spoke. Even after the vocational rehabilitation file was closed on June 26, 1984, he came by Mr. Parsons' office twice. Both times K.D. seemed depressed to Mr. Parsons, who had recommended he go for counseling to the Human Resources Center, a community mental health center. Mr. Parsons saw K.D. for the last time on March 22, 1985. At least as early as August of 1984, K.D. mentioned suicide to Mr. Parsons as a possibility. In March of 1985, K.D. began weekly counselling sessions with Dr. Rafael Parlade, a clinical psychologist at the Human Resources Center. In these sessions "the two issues . . . were his suicidal ideation combination with the depression, and the departure of his live-in girlfriend." (T. 273) He "still had a lot of pain." (T. 274) Dr. Parlade hoped K.D. would "increase his activities," (T. 276) so that with . . . activity in his life more, he would focus away from his pain. Because for a period of time that was all he was living with. (T. 276) Dr. Parlade viewed decreasing the amount of pain medication as a secondary goal (T. 275), a result he hoped would flow from K.D.'s being less preoccupied with the pain he experienced continually. PAIN REMEDIES On January 31, 1983, K.D. visited Dr. Villaflor's office. Dr. Villaflor's notes for that day mentioned K.D.'s "Electrocution High Voltage in 7/81" and reflect a prescription for 50 tablets of Talwin. K.D.'s blood pressure, 120 over 70, is noted, and reference is made to a TENS unit, or transcutaneous nerve stimulator. Somebody at the Orlando Pain Clinic K.D. had visited had recommended one of these electrical devices to K.D., but it had proved ineffective against his pain. At one time or other, K.D. resorted to acupuncture and resumed wearing a corset of the kind originally prescribed for the back pain he experienced in the wake of the cascading motorcycle accident. Dr. Villaflor's office notes of April 15, 1983, record "Back Pain," a second prescription for 50 tablets of Talwin and another prescription for Xanax. On May 11, 1983, Dr. Villaflor's records again note K.D.'s "Back Pain" and indicate prescriptions for Xanax and Percocet. Nothing suggests Dr. Villaflor knew that Talwin had been dispensed to K.D. five days earlier, when K.D. appeared at his office on May 26, 1983. Essentially illegible, Dr. Villaflor's office notes for May 26, 1983, reflect prescriptions for Percocet and Xanax tablets, with which K.D. obtained 30 quarter milligram Xanax tablets on June 6, 1983, and 35 Percocet tablets on June 8, 1983. Xanax, a tranquilizer, is taken three or four times daily. Since Percocet may be taken every four to six hours, it was "very much within reason" (T. 239) for Dr. Villaflor to prescribe more on June 9, 1983. When this prescription was filled on June 22, 1983, K.D. received 45 tablets. On July 7, 1983, Dr. Villaflor saw K.D. at his office for the first time in almost a month, and prescribed 35 more tablets of Percocet, also known as oxycodone with acetaminophen. The same day K.D. had the prescription filled, obtaining 35 tablets. Some three weeks later, on July 29, 1983, Dr. Villaflor again prescribed and K.D. again obtained 35 Percocet tablets. On the same day two other prescriptions Dr. Villaflor wrote for K.D. were filled, one for Atarax, an antihistamine sometimes prescribed in lieu of a tranquilizer, and one for Tylenol with codeine. This 35-tablet Tylenol prescription was refilled on September 7, 1983. With more and less potent pain medications, K.D. could take one or the other, as appropriate, depending upon the intensity of the pain. Since no other prescription for pain killing medication was written or filled until October 4, 1983, these prescriptions were, according to one of the Department's witnesses, "[w]ithin reason." (T. 243) On the October 4 visit, Dr. Villaflor noted "Back Pain from Electrocution" and recorded K.D.'s blood pressure as 138 over 70 or 80, before prescribing 45 Percocet tablets. That day, K.D. obtained the Percocet. He returned to Dr. Villaflor's office on October 13, 1983, complaining not only of back pain, but also of nausea and vomiting. Dr. Villaflor prescribed an additional 30 Percocet tablets. On October 15, 1983, K.D. acquired 50 tablets of the antihistamine Dr. Villaflor had been prescribing for him, "hydroxizine pam." On November 3, 1983, he obtained 60 Percocet tablets and 50 Tylenol No. 3 tablets. On November 12, 1983, the antihistamine prescripton was refilled as was, on November 16, the Tylenol No. 3 prescription. Perhaps Dr. Villaflor wrote the antihistamine prescription two days before it was first filled. The office notes are difficult to decipher. He wrote the Percocet and Tylenol prescriptions when he saw K.D. on November 3, 1983, at which time he recorded his blood pressure (132 over 70) and noted "back injury." On December 2, 1983, Dr. Villaflor's office notes reflect a visit and prescriptions for Tylenol No. 3, Percocet and the antihistamine. With respect to prescriptions filled on and after November 3, 1983, but before December 2, 1983, DPR's witness testified that the amount of medication was "a little high, but it's still, you know, again, acceptable for a person in pain." (T. 246) On December 2, 1983, K.D. obtained 60 Percocet tablets and 50 Tylenol No. 3 tablets, the latter by virtue of a prescription that was refilled on December 14, 1983. On January 3, 1984, K.D. returned to Dr. Villaflor's office where he obtained prescriptions for Percocet and Tylenol No. 3. In March, Dr. Villaflor began prescribing a tranquilizer, Dalmane, instead of the antihistamine, but the new year progressed much as the old year had, in terms of Dr. Villaflor's prescriptions and documentation, and, apparently, of K.D.'s pain, as well, until early August. On August 3, 1984, Dr. Villaflor prescribed for K.D., 200 "Sk- Oxycodone w/Apap" tablets, 200 Tylenol No. 4 tablets and 180 Dalmane capsules. K.D. had asked for them to take along to New England, where he travelled for an extended visit with his parents and others. This represented more than a two months' supply, and the prescriptions inspired a pharmacist, Paul Douglas, to telephone Dr. Villaflor's office before filling them. Mr. Douglas had called once before in the spring of the year, when he noticed that a total of 100 Tylenol (acetaminophen with codeine) No. 3 tablets and 60 tablets of Percocet (or the generic equivalent) had been dispensed to K.D. for use over a 24-day (April 2 to April 26, 1984) period. The pharmacist was concerned on that occasion because K.D. would have needed only 144, not 160, tablets during that period, if he had been taking no more than one every four hours. Back in Daytona Beach, K.D. presented himself at Dr. Villaflor's office on November 5, 1984, and received prescriptions for 45 tablets of Percocet, 55 tablets of Tylenol No. 3 and a quantity of Dalmane. All three prescriptions were filled the same day, and the prescription for Tylenol No. 3 was refilled on November 19, 1984. After his last telephone call to Dr. Villaflor's office, the pharmacist talked to K.D., telling him he would "not fill these medications again . . . until the prescribed number of days." (T. 222). On December 5, 1984, K.D. appeared a second time after his return from up north, and Dr. Villaflor again prescribed all three drugs, this time specifying 50 tablets of Percocet and 50 tablets of Tylenol No. 3. K.D. caused these prescriptions to be filled the day he got them. The office notes for both these visits mention only electrical shock by way of explanation for the prescriptions. On December 19, 1984, Dr. Villaflor suffered a stroke and was hospitalized. Two days later prescriptions he had purportedly written for K.D. were filled, but their authenticity, like that of the prescriptions filled on November 21, 1984, is not certain. While Dr. Villaflor was indisposed on account of the stroke, Dr. Wagid F. Guirgis filled in for him. The day he began, K.D. came in complaining of severe pain in his lower back and legs. Dr. Guirgis prescribed Dalmane, 50 Percocet tablets and 50 Tylenol No. 3 tablets, the latter prescription being twice refillable. Dr. Guirgis suggested to R.D. that he see an orthopedist or a neurologist, and, on January 21, 1985, refused K.D.'s request to prescribe more Percocet. At no time did Dr. Guirgis and Dr. Villaflor discuss K.D. or his treatment. Later the same day K.D. went to Dr. M.H. Ledbetter's office. This osteopath prescribed 30 Percocet tablets to be taken twice daily, as well as Elavil and Tranxene. On February 4, 1985, Dr. Ledbetter prescribed the same medicines. On February 28, 1985, Dr. Ledbetter prescribed Elavil, Librium and 50 tablets of Percocet. On March 22, 1985, he prescribed the same things. On April 19, 1985, K.D. again visited Dr. Ledbetter. The same day he purchased Librium and 60 Percocet tablets at Walgreen's. Dr. Ledbetter prescribed Librium, Elavil and 60 tablets of Percocet, to be taken twice daily, when he saw K.D. on May 16, 1985. In May Dr. Villaflor returned to his office, and K.D. appeared on May 21, 1985, five days after he had seen Dr. Ledbetter. Dr. Villaflor prescribed 60 Percocet and 50 Tylenol No. 3 tablets for K.D., along with Dalmane and a vitamin (Bl2) injection. K.D. weighed 142 pounds that day and his blood pressure was also noted. The office notes report "same complaints." On June 18, 1985, Dr. Villaflor prescribed 60 Percocet tablets, ten fewer than he prescribed on K.D.'s next visit, on July 17, 1985 , when K.D. limped "on left foot." In July, Dr. Villaflor also prescribed Dalmane and 50 Tylenol No. 3 tablets. On both visits K.D.'s weight (142 then 138) and blood pressure (122 then 120 over 80) were noted. On August 19, 1985, K.D.'s weight had fallen to 132 pounds but his blood pressure remained 120 over 80. Sixty Percocet tablets - one every four hours - were prescribed, as were 50 Tylenol No. 3 tablets. The diagnosis indicated in Dr. Villaflor's office notes was "electrocution." On September 16, 1985, Dr. Villaflor again prescribed Dalmane, Tylenol and 60 Percocet tablets. On October 17, 1985, K.D. limped to his last visit to Dr. Villaflor's office. His face bruised, K.D. complained that both feet were swollen, and reported that he had lost his balance and fallen down four stairs and over a concrete wall. For the last time, Dr. Villaflor prescribed Tylenol No. 3 and Percocet for K.D., 30 and 60 tablets respectively. Unbeknownst to Dr. Villaflor, K.D. had continued to visit Dr. Ledbetter, himself unaware of Dr. Villaflor's renewed involvement with K.D. On June 7, July 5, July 26, August 27, September 16 and October 10, 1985, Dr. Ledbetter prescribed Librium, Elavil and Percocet. Dr. Ledbetter's office notes also reflect K.D.'s fall. REQUIRED PRACTICE Keeping complete medical records is important not only as a mnemonic aid for the treating physician, but also to make the patient's history available to other physicians who may succeed or assist the recordkeeper. Although each is "a moderate type of analgesic," (T. 324), both codeine and oxycodone are "narcotic derivatives . . . [and] addictive in nature." Id. Dalmane "can be" (T. 221) "potentially addictive." Id. Because of his depression, K.D. "was not a good candidate" to entrust with several hundred pills at once. A physician who suspects addiction should limit prescriptions to "around ten to fifteen" (T.326) tablets and "start checking with other pharmacies to make sure if a patient is getting drugs from any other source . . . ." Id. He should perform "very close and repeated physical exams" (T. 327) and be alert for "overdose side effects," id., such as dizziness, slurred speech, or staggering. The evidence here fell short of a clear and convincing showing that Dr. Villaflor was remiss in failing to suspect addiction, however, Dr. Ledbetter, who had similar, albeit similarly incomplete, information apparently did not suspect. The evidence did not prove the existence of side effects from the drugs Dr. Villaflor prescribed. Although, on his last visit to Dr. Villaflor's office, K.D. reported dizziness, the cause is unknown. On the other hand, his office records do not suggest that Dr. Villaflor took any steps to determine the cause of K.D.'s dizziness or of his swollen feet. Dr. Villaflor's treatment of K.D. fell below acceptable levels, if he failed to refer K.D. for periodic reevaluations of the underlying orthopedic or neurological problem, which his records suggest he did not do. His treatment was also inadequate for failure periodically to "get the medicine . . . out of the system . . . for a limited time" (T. 337) in an effort to learn what side effects, if any, the drugs he prescribed caused, either singly or in combination. This is so, even though the effort might have been frustrated, if K.D. had acquired the same medicines from other sources.

USC (1) 21 CFR 1301.72 Florida Laws (2) 458.331893.07
# 1
BOARD OF MEDICAL EXAMINERS vs. TEOTIMO D. BONZON, 82-000799 (1982)
Division of Administrative Hearings, Florida Number: 82-000799 Latest Update: Mar. 03, 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.

Florida Laws (2) 120.57458.331
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BOARD OF MEDICAL EXAMINERS vs. SOLOMON D. KLOTZ, 83-002370 (1983)
Division of Administrative Hearings, Florida Number: 83-002370 Latest Update: Jul. 03, 1984

Findings Of Fact The Respondent, Solomon D. Klotz, M.D., at all times pertinent hereto, has held a current, valid medical license number ME 0002269, issued by the Board of Medical Examiners, Department of Professional Regulation, which is the agency charged with enforcing Chapter 458, the "Medical Practice Act," as it relates to qualification for licensure and standards for regulating medical practice of physicians licensed in the State of Florida. The Respondent is also board- certified by the American Board of Internal Medicine in internal medicine and is board- certified in the field of allergy and immunology by the American Board of Allergy and Immunology. The Respondent obtained his M.D. Degree from New York Medical College in 1937, obtaining a Masters from that institution in 1942. He was licensed in New York in 1938 and was made a diplomate of the National Board of Medical Examiners in 1938. He was issued his Florida license in 1941. He served in the Medical Corps of the United States Army in World War II and during the years 1945 and 1946 was a clinical instructor at New York Medical College, and a research fellow at Metropolitan Hospital Research Unit in New York. The Respondent has practiced in his specialty field of internal medicine as well as allergy and immunology in Florida for many years. He is presently a clinical professor at the College of Health of the University of Central Florida, and an adjunct professor at the Department of Biological Sciences at the University of Central Florida. Respondent is presently on the medical staffs at Winter Park Memorial Hospital, Florida Hospital, Orlando Regional Medical Center and Humana Hospital/Lucerne, with a senior consultant rating at each of the above hospitals. The Respondent is a member of 21 professional societies and was a founding member of the Salk Institute for Biological Studies and, the board of the Joint Council of Allergy and Immunology. He has served as president of the American College of Allergists, the Florida Allergy Society, Southeastern Allergy Society, and is president of the medical staff of Florida Hospital in Orlando. The Respondent has published or presented more than 50 research papers, seven of which have been published within the past three years in such journals as the Annals of Allergy, the Journal of the Florida Medical Association, the Journal of the American Academy of Allergy and Immunology and the American Heart Journal. Concerning the disease or condition most pertinent to the charges in the administrative complaint, the Respondent published a paper jointly with Dr. Von Hilsheimer in 1970 concerning minimal brain dysfunction, attention disorders and the diagnosis of functional narcolepsy. Dr. George Von Hilsheimer was accepted as Respondent's expert witness concerning the diagnosis of narcolepsy and the various forms or manifestations of narcolepsy and the treatment thereof. He is a licensed psychologist in the State of Florida, having been educated at the University of Miami with postgraduate work at the University of Chicago. He interned in psychology at the Corsack Clinic and the Seabrook Institute in San Francisco. He completed his Ph.D. in psychology with a multiple major in neuropsychology, psychoimmunology and psychotherapy. He is an associate fellow in the Society for Clinical Ecology, a consultant to the Science Advisory Committee of the Environmental Protection Agency as a neuropsychologist and behavioral toxochologist. He is eligible for board certification by the Academy for Psychosomatic Medicine and the American Academy of Behavioral Medicine. He has published numerous reference papers and a number of books, one of which books focused on the diagnosis of minimal brain dysfunction and the issue of psychosomatic versus somatic causes for behavior. He has presented two papers in conjunction with the Respondent on the issue of minimal brain dysfunction, tension disorders and the diagnosis of functional narcolepsy. Since 1980, Dr. Von Hilsheimer's practice has been split between psychotherapy and psychoimmunology. In the past ten years he has presented numerous continuing education workshops for physicians, which courses were certified by the American Medical Association. Dr. Dale K. Lindberg, M.D., was accepted as an expert witness for the Petitioner regarding the pharmacological effects, uses and indications of the drugs related to the charges in the administrative complaint. Dr. Lindberg has been a licensed physician in the State of Florida since 1959. He is board certified in nuclear medicine. He took a residency in nuclear medicine at Mt. Sinai Hospital in Miami Beach between the years 1974 and 1977. Since 1973, his practice has been limited to primarily that of supervising methadone maintenance programs and clinics. Prior to 1973 his practice was in the area of family practice, as well as nuclear medicine. He is a member of the Broward County Medical Association, Florida Medical Association, American Medical Association, Broward County Family Practice Association, as well as the Society of Nuclear Medicine. Dr. Lindberg has never treated a patient with narcolepsy nor has he seen patients exhibiting the various kinds of narcoleptic behavior. METHAQUALONE PRESCRIPTIONS; COUNTS I, II AND III The first three counts in the administrative complaint concern prescriptions written June 24, 1982, for allegedly excessive and unjustified amounts of a controlled substance, methaqualone, prescribed to patients Harri Klotz (Count I) , Sam Meiner (Count II) and Charles Meiner (Count III). Those prescriptions consisted of 121 sopor (150 mgs) for Harri Klotz; 189 parest for Sam Meiner; and 34 quaaludes for Charles Meiner, all of which are methaqualone medications. The Respondent received a telephone call on or shortly before June 24, 1982, the date the prescriptions were written, from a pharmacist whom he regularly dealt with, who informed him that, inasmuch as, effective July 1, 1982, he would be unable to fill methaqualone prescriptions due to a change in the law by which it became a Schedule I drug, that he would make available the small quantity of methaqualone remaining in stock to the Respondent for his patients who required the drug. The Respondent acknowledged having a few such patients and accordingly wrote prescriptions for the above odd numbers of capsules to patients whom had been regularly receiving methaqualone medication for a period of time previously. Patient Harri Klotz is the Respondent's wife. She has been a patient of Respondent since approximately 1940. She suffers from generalized osteo- arthritis involving mainly the hips, which was first diagnosed in 1967. Due to progressive severity of the disease she received surgery in October, 1970, in Germany, for replacement of both hip joints with artificial prosthesis. Since that time the right hip prosthesis joint cracked, causing her severe, chronic pain which caused her great difficulty in sleeping. After taking numerous combinations of medicine, Mrs. Klotz was found to respond most effectively to methaqualone, which induced sleep in spite of the pain, without undesirable side effects the next morning. She ultimately had the right hip prosthesis repaired. Her medical records indicate that this medication had also been prescribed for her by her treating physicians when the prosthetic devices were implanted. In 1981 she again began experiencing the same type of agonizing, chronic pain in her left hip and consulted an orthopedic surgeon at regular intervals concerning it. It was not until November, 1952, however, that the diagnosis was made that her left prosthesis had also broken. During the various attempts to diagnose the cause of this problem with her left hip, she was experiencing severe, chronic pain. Finally, after a third stint of surgery the left hip prosthesis was replaced and her symptoms ultimately improved. In the meantime however, on October 14, 1981, Respondent purchased 1,000 quaaludes for his wife. He did not dispense the entire lot to her, rather she was given 30 capsules at a time for use in inducing sleep during the period when she suffered from her painful condition at intervals of one and one-half to two months. The Respondent carefully monitored her dosage and kept the balance under lock and key at his office, duly recording on a dispensing record the capsules actually given to his wife on each occasion. On June 24, 1982, before methaqualone became a Schedule I Controlled Substance, he last prescribed that substance for his wife when he wrote the prescription for 121 sopor. He has not since prescribed a methaqualone substance to his wife. On June 24, 1982, the Respondent prescribed methaqualone to Sam Meiner. Mr. Meiner (Respondent's counsel) has been a patient of the Respondent since approximately 1968. Be suffers from a severe, chronic painful condition called regional enteritis, a condition characterized by severe, chronic pain and acute bowel spasms associated with acute exacerbations of the enteritis condition. As a result of this condition he has had two bowel resection surgeries, during the course of which surgeons removed approximately six feet of his small intestine. He has suffered from this disease chronically for approximately 18 years, having his first surgery in 1967 and the second in 1977. "hen the enteritis condition became acutely inflamed after his second surgery, he once again sought Respondent's medical advice. He has been a continuous patient of the Respondent ever since that time, seeing him almost on a weekly basis. Included in the total medical care Respondent has given this patient is a prescription of methaqualone for its beneficial soporific and antispasmodic effects designed to curtail the severity and duration of the bowel spasm incidents. Other physicians, as well as Respondent, in treating this patient have attempted many other combinations of medications before the Respondent and patient determined that methaqualone was the most effective modality. Since being under the Respondent's care with attendant methaqualone medication, the patient has required no hospitalization and has been able to lead a substantially normal existence, even though this disease or condition if unsuccessfully treated can ultimately prove fatal, especially if additional such surgical procedures are resorted to. Witness Meiner was shown to have no abnormal adverse effects nor physical or psychological dependence on the drug. It is now no longer legally obtainable, the patient being afforded his last prescription therefor on June 24, 1982, some six days before the prescription of the drug became illegal. On June 24, 1982, the Respondent prescribed 34 methaqualone capsules to Charles Meiner. Charles Meiner (also counsel for Respondent) suffers from a chronic, severe back injury involving a ruptured or degenerative disc. He periodically suffers excruciating, chronic back pain, resulting in his inability to sleep. He has been a patient of the Respondent since 1969. In 1973 he required hospitalization due to the severity of the back pain. lie has seen the Respondent for this problem at regular intervals ever since. He had been prescribed methaqualone on a number of occasions prior to June, 1982, as the medication helps his insomnia resulting from the chronic back pain, without imposing any adverse effect the following morning or inhibiting his ability to function in the legal profession. Be has never taken more than one tablet per day and some days only a half tablet during the course of his back pain flare- ups. In May of 1982, his back condition became particularly severe, with persistent pain. Because of this exacerbation of his back condition, he was given a prescription for 34 quaalude tablets on June 24, 1982, to relieve his pain and enable him to sleep. During the time Respondent prescribed methaqualone to these three above-named patients, methaqualone was an acceptable medication for relief of the symptoms these patients exhibited. Petitioner's witness Dr. Lindberg acknowledged that the prescribing of methaqualone by the Respondent to these patients on or before July 1, 1982, was for a medically justifiable purpose, and that the dosages involved were within recommended daily dosages for the treatment of the symptoms exhibited by these patients, as depicted in the Physician's Desk Reference (PDR) a work relied on by both parties throughout this proceeding. AMPHETAMINE PRESCIPTIONS: COUNTS IV, V, VII, XI, XII, XIII, XIV, XVI, XVII, XVIII and XIX. The prescription of amphetamines became restricted as to use by the enactment of Section 458.331(1)(cc) , Florida Statutes, effective August 30, 1980. This restricted the prescription of any drug which is an amphetamine or a sympathomimetic amine drug (a Schedule II drug) except, as pertinent here, for the condition of narcolepsy. Prior to the restriction of the drug, the Respondent had prescribed such drugs for short-term use for patients who were attempting to embark on a successful weight-control program. The Petitioner's expert witness, Dr. Lindberg, acknowledged that this was a medically appropriate use of this type of medication at the time and that he himself had made similar prescriptions for similar purposes. The Respondent conceded that as of July 3, 1980, that he was not aware of the change in the legal status of amphetamine type drugs by the enactment of the above statute, and did not become aware of such restrictions until the pharmacist with whom he regularly dealt informed him that he could not prescribe Biphetamine, Dexedrine or other sympathomimetics unless the patient had a narcoleptic condition. Upon becoming aware of this restriction after August 30,1980, the Respondent discontinued use of those drugs except for the treatment of narcoleptic symptoms in patients. Dr. Lindberg opined that the only type of narcolepsy he would recognize was "ideopathic narcolepsy." By this he meant that he would only diagnose narcolepsy when all four recognized symptoms are present: excessive daytime sleepiness, cataplexy (a condition when muscles become limp) , hypnogogic hallucinations (dreams shortly before going to sleep or upon awakening) and sleep paralysis whereby the patient is unable to move, although the limbs are not rigid. Dr. Lindberg has never treated a patient with narcolepsy nor has he ever observed a patient exhibit narcoleptic behavior in his practice. Both the Respondent and Dr. Von Hilsheimer, the Respondent's expert witness on the subject, have studied and treated this condition and published recognized research papers on the subject of narcolepsy. Further, the Respondent in connection with his speciality in the field of allergies, has performed testing regarding patients with certain food sensitivities and has observed that some of them will exhibit narcoleptic symptoms as a reaction to certain foods. Dr. Von Hilsheimer, as delineated above, has extensive experience in the diagnosis and treatment of narcolepsy in its various forms and in teaching recognition of the condition to doctors through continuing education courses. Idiopathic narcolepsy, the extreme or classic view of the disease, may involve exhibition of all four of the above symptoms in a patient, however, only 10 percent of patients legitimately diagnosed as narcoleptic present all four symptoms, and therefore most of the scientific and medical community uses the term "narcolepsy" In a broader, more general sense to mean essentially excessive, inappropriate daytime sleepiness, especially at inappropriate times. In addition to narcolepsy being a primary affliction, it can also be a subsyndrome, or secondary disorder related to a different medical problem. It can be permanent or can be a transient condition and can be a by-product of unusual psychological or physical stress. The Respondent prescribed a small dosage of an amphetamine for Nina Balabon between January 11, 1980, and September 17, 1982, at various times. (Count IV) Ms. Balabon is a 92 year old woman who has been taking a very small dosage of Dexedrine for many years. The dosage is substantially below that allowable for such a patient as conceded by the Petitioner and delineated in the Physician's Desk Reference. Ms. Balabon lives alone in Woodstock, New York, and is the foster mother of the Respondent's wife. She had been under the care of another physician who prescribed this course of treatment and drug for her so that she could remain alert enough to independently function and take care of herself in her own home. She is home-bound and after her doctor's death, she was unable to secure another doctor who would make house calls. She called upon the Respondent who is, in effect, a family member, and financially supports her, and asked him to prescribe the medication for her, in conjunction with which she retained the services of a visiting nurse. In her old age she has become afflicted with lassitude, inappropriate and excessive daytime sleepiness, depression and a diminished "will to live." The Respondent visits her in Woodstock, New York, periodically and he or his wife, telephone her at least once a week. A visiting nurse checks on her condition weekly and reports to the Respondent on her physical condition. The Petitioner's expert witness, Dr. Lindberg, has never seen this patient, but surmised upon her recorded weight that she is slightly malnourished. Accordingly, he opines that it is inappropriate to give a person with such a condition (slight malnourishment) amphetamines to curb her appetite and provide her "pep." The Respondent, however, did not prescribe amphetamine for this purpose. Be found, in the exercise of his medical judgment that she exhibits definite symptoms of narcolepsy. The dosage is extremely small and the patient is not shown to suffer any adverse effects therefrom. It was not shown that the dosage curbed her appetite, and indeed, Respondent established that the patient is not malnourished. She is a very small, slightly built woman and her mere recorded weight is not an indication in itself of malnourishment such that the prescription involved would be contraindicated. Petitioner's expert witness, further was unaware that the patient exhibited symptoms of narcoleptic behavior, and admitted that otherwise the dosages were quite small and not excessive for such a patient. Dr. Lindberg merely opposed the prescription of the medication because he believed that the law changed regarding the use of this drug, such that after August 30, 1980, it is only permissible for narcoleptic symptoms. In any event, the Respondent's diagnosis of the patient was uncontradicted and the 92 year old patient was shown to benefit from this treatment of her condition because it permitted her, with the assistance of the visiting nurse, to continue living independently rather than suffering commission to a nursing home or other institutional facility. Count VII concerns alleged prescriptions of amphetamines to one Doris Calloway between February 16, 1982 and October 13, 1982. Petitioner failed to introduce any evidence or testimony concerning this count. With regard to Count XI, Respondent prescribed on only one occasion, 50 Biphetamine capsules for Lori Carroccia on September 29, 1980. At the time this prescription was written and issued, the Respondent was unaware of the recent restrictions imposed by the legislature on the purposes for which amphetamine-type drugs could be prescribed by the passage of Section 458.331(1)(cc), Florida Statutes, effective July 1, 1980. The Respondent had known this patient for approximately six years and she was his nurse, employed at his clinic at the time the prescription was written. The single prescription was written when she complained to him of difficulty in starting a weight loss program and asked for his assistance. Prior to writing the prescription, he checked Ms. Carroccia's physical health, checked her weight and blood pressure, and indeed was already aware of her medical history because of his close association with her. During the entire two months she received this medication Respondent saw her on a daily basis and monitored her progress. The medication proved to be an effective means for her to develop a successful weight loss program. She suffered no adverse effects from receiving this drug. The Respondent only prescribed this medication once, in a small dosage to Initiate her weight loss program and not for the purposes of maintaining weight loss or a particular weight level through long-term prescriptions. Petitioner's sole expert witness conceded that the dosages were not excessive and were medically indicated in the PDR for the initiation of such a weight loss program. Petitioner's expert witness admitted that his opinion regarding inappropriateness of the prescription was solely predicated on the change in the legal status of the drug. The Respondent prescribed an amphetamine medication to patient Evelyn Lilly between April 14, 1981 and December 19, 1981 (Count XII). Ms. Lilly had been his patient since 1979 for allergy evaluation and treatment to alleviate chronic symptoms of runny nose, throat infections and irritations and sinus headaches. Respondent gave her an allergic evaluation in response to these symptoms. In completing her patient history he noted that Ms. Lilly suffers from rheumatism and arthritis. During the course of her allergy treatments Ms. Lilly's weight began increasing dramatically, with a worsening of her arthritic condition. Respondent noted she was markedly fatigued and became concerned about her general physical condition. In response to her fatigue or lassitude complaints, he initially performed a thyroid test in an effort to determine the cause of her lassitude and rapid weight gain. That test was inconclusive. lie then decided that between the complications of arthritis and her allergies he must reduce her weight before he could successfully treat either of those conditions. He initially prescribed Tenuate Dosepan which proved ineffective and then Ritalin, which also proved ineffective. She was then prescribed a course of Biphetamine. She responded dramatically to this medication with relief of her lassitude and the loss of 30 to 40 pounds. After noting that the initial sympathomimetic type drugs prescribed were ineffective and that the change to the Biphetamine produced markedly successful results, Respondent came to the conclusion that the patient was narcoleptic. Narcolepsy sometimes is not alleviated with the prescribing of one type of sympathomimetic drug when the switch to treatment with another type will suddenly prove to be successful in alleviating the narcoleptic symptoms. The doctor's chart for this patient did not definitely indicate the purpose of the prescription of the amphetamine medication, although Dr. Klotz candidly responded in his testimony that it may have been in part for weight control because a reduction in weight would help alleviate her arthritic joint problems. However, inasmuch as narcolepsy can be indicated when one type of sympathomimetic drug will not relieve its symptoms and another type will and since is. Lilly in her reaction to the medications displayed this phenomenon, Respondent, in the reasonable exercise of his medical judgment concluded that she displayed symptoms of narcolepsy. This view is corroborated by Dr. Von Hilsheimer. He has had more than 1,000 patients referred to him over the years by the Respondent. Approximately one-third of these patients were obese and yet he was only aware of four such patients who were treated with biphetamines by the Respondent. Be thus concludes that the Respondent used some differential reason other than mere weight control for prescribing biphetamine which led to the diagnosis of symptomatic narcolepsy with Ms. Lilly. The Petitioner's expert witness once again felt that the Biphetamine and Ritalin prescriptions for Ms. Lilly were inappropriate and excessive, but acknowledged that his criticism of these prescriptions was predicated solely on the fact that the medication had become illegal for prescription for weight control purposes before Ms. Lilly's prescriptions were made. Dr. Lindberg ultimately agreed however, after consulting the PDR that the amounts and types of medication were within appropriate indications, dosage limits and amounts and thus the amounts prescribed were within the reasonable exercise of the Respondent's judgment as a physician for the symptoms displayed, and alleviated them. Concerning this patient, as with all the others involved herein, Petitioner's expert witness bases his testimony merely on the doctor's patient chart which does not specifically refer to narcoleptic symptoms. Respondent admits his records are not detailed in all cases, since the patients were not referrals, but were his patients for many years such that he was intimately familiar with their histories and conditions. Based on the lack of reference to narcoleptic symptoms in the records themselves, Dr. Lindberg opined that the prescription was medically inappropriate, however, the mere absence of reference to that condition in the medical records alone does not establish the medical inappropriateness of the prescription, especially in view of the Respondent's showing (corroborated by Dr. Von Hilsheimer) that indeed Ms. Lilly was narcoleptic. Mr. Emmett Peter was prescribed biphetamines between October 16, 1979 and September 14, 1982 by the Respondent (Count XVI). Mr. peter has been Respondent's patient since 1969 and `gas definitely diagnosed as a narcoleptic individual by a physician who treated him prior to that time and related that fact in his initial medical history provided Respondent. At the time he and his wife became patients of the Respondent, Mr. Peter was receiving a medication called Obedrin, which is a dexedrine-type drug. During the entire time he received medication from the Respondent, he periodically visited the Respondent on his own behalf, as well as accompanying his wife to the Respondent's clinic for treatment, at which times the Respondent also observed Mr. Peter. Although the Respondent was unaware of the change in the law regarding restriction of the use of amphetamines to the treatment of narcolepsy at the time he prescribed Mr. Peter's medications at issue in this case, he continued to prescribe the medication for Mr. Peter after he became aware of the law, because he definitely diagnosed Mr. Peter to be a narcoleptic. The Respondent's expert witness, Dr. Von Hilsheimer, has seen both Mr. and Mrs. Peter on a professional basis as a researcher. He had numerous occasions to observe Mr. Peter, approximately twice a week from March, 1980 through May, 1982. Be became quickly aware of the fact that Mr. Peter was narcoleptic due to the fact that Mr. Peter, when waiting for his wife at Dr. Von Hilsheimer's office, often fell asleep in a very dramatic way, sometimes even when Dr. Von Hilsheimer was engaged in conversation with him. It was thus established that Mr. Peter, based upon his medical history and the personal observation of both Dr. Klotz and Dr. Von Hilsheimer, suffers from a minimal brain dysfunction manifested as excessive, inappropriate sleepiness. Dr. Von Hilsheimer further noted that Mr. Peter's condition is also characterized by moderate cataplexy, another symptom of narcolepsy. There is no question that Mr. Peter suffers from narcolepsy, therefore the prescription of amphetamine medications to Mr. Peter was clearly medically appropriate and the Petitioner admitted that the amounts of the medication were not excessive. On February 24, 1981, Charne D. Porter, the Respondent's daughter was given a prescription for 30 10-mg Ritalin tablets (Count XVII). The Respondent has been her treating physician most of her life. At the time the prescription was written she was editing and producing a motion picture. She was working very long hours and complained to Respondent that she was having difficulty staying awake during all times of the day and in completing her film-editing work. Prior to this period of time however, her typical work schedule involved such long hours with no apparent ill effects. This was not an unusual work schedule for her. Dr. Von Hilsheimer has known Ms. Porter since 1979 and she has consulted him professionally in the past. He was quite familiar with the patient history and had occasion to see her during the time the medication involved was prescribed. During this period of time he found that when she was attempting to do film-editing work which is normally a stimulating, arousing type of endeavor, she did not have her normal responsiveness and while talking to him would doze off in the middle of a conversation in his office. The work she was trying to do at the time was quite arousing under unusual conditions of lighting and interest and yet she would still doze off at inappropriate times during the day while working. The doctor did not find that her long work schedule or hours were responsible for such a condition. Ms. Porter had a debilitating illness consisting of the lingering aftereffects of a form of hepatitis and this, coupled with the stress related to her film-editing job (for which she was obtaining treatment through self-hypnosis training by Dr. Von Hilsheimer) caused her to lose her normal "arousal ability." Because of this she did have an attack or episode of transient narcolepsy as diagnosed by Respondent and Dr. Von Hilsheimer. During visits in his office he observed her display three of the four commonly recognized symptoms of narcolepsy during approximately the same period of time in which she received the Ritalin prescription. These inappropriate sleep episodes were a transient condition and Ms. Porter recovered from that condition and is functioning well personally and professionally. The small original Ritalin prescription needed no renewal. The use of the Ritalin prescription was a reasonable exercise of Respondent's medical judgment and approach to alleviating the transitory narcolepsy symptoms exhibited by Ms. Porter and caused her no harm whatever. Patient Sandy Lee Bradford was prescribed Biphetamine between December 14, 1980 and December 15, 1981. She is the daughter of the Respondent's secretary and has been the Respondent's patient for many years. On December 15, 1980, due to her complaint of fatigue, daytime sleepiness episodes, along with inability to lose weight and excessive weight gain, the Respondent first prescribed biphetamines to her. Over a one year period she subsequently received four other prescriptions of biphetamines. Each time she received a new prescription, she personally saw and consulted with Dr. Klotz. At the time the prescriptions were administered she had recently been divorced and was suffering unusual stress and emotional anxiety related to that divorce, which Respondent believed had a direct effect on her sudden weight gain and inability to lose weight. At the time the Respondent made these prescriptions, he was as yet unaware of the change in the legal status of amphetamine-type drugs such that it was no longer legally permissible to prescribe them for weight loss purposes. The Respondent candidly admitted that he primarily prescribed the drugs for assisting her in embarking on a successful weight loss program, not for chronic use. Other anorectic medications had been tried on this patient and had proved ineffective, however, with the judicious prescription and use of the biphetamine medication the patient made substantial progress in losing weight and in alleviating symptoms of fatigue. When Respondent became aware of the change in the legal status of biphetamines, he discontinued that medication promptly and substituted Tenuate Dosepan, which proved ineffective. He then substituted Ionamine which also proved ineffective, in an attempt to avoid prescribing biphetamines for the patient. The biphetamines prescribed were in appropriate, non-excessive quantities for the condition and symptoms exhibited by the patient and successfully alleviated her complaints with no harm to the patient. He discontinued biphetamines because he felt he could not with reasonable medical certainty, diagnose her as a narcoleptic patient. Dr. Lindberg conceded that the prescriptions were medically appropriate, but for the change in the law regarding their permissible use, and that change was the sole basis for his opinion that the prescription was inappropriate. Patient Trudy Heintz was prescribed Dexedrine between January 3, 1980 and October 29, 1982. She has been a patient of the Respondent since the early 1950's. She has displayed, over many years, symptoms of excessive, inappropriate daytime sleepiness and a simple inability to perform her employment duties as a result. The Respondent was treating her for phlebitis and arthritis, and thus she is an internal medicine patient. As such the Respondent monitored her physical condition quite closely, making physical examinations including monitoring of blood pressure when necessary. He observed no adverse effects caused by the administration of Dexedrine to this patient, which alleviated her narcoleptic symptoms and enabled her to remain productive and fully functional in her employment and daily pursuits. The Respondent thus diagnosed her as suffering from narcolepsy and established that as an appropriate basis for the prescription of Dexedrine. He continued to prescribe Dexedrine for the patient, even after he became aware of the restriction of its use because he genuinely believes that she is a true narcoleptic. Dr. Lindberg opined that the Dexedrine was inappropriate medication and was prescribed in excessive amounts. He did not believe that Ms. Heintz exhibited narcoleptic behavior, but he had never observed the patient and based his opinion merely upon less than detailed references to narcoleptic behavior in the patient's records. The Respondent, however, established that this patient had been a patient for many years and he was intimately familiar with the physical condition, complaints and medical history, and makes notes only for his own use. Because of his familiarity with her medical history and problems, it was unnecessary for him to make his own notes in sufficient detail so that Dr. Lindberg would be able to thoroughly review the patient's status and treatment indications by looking at her chart alone. Dr. Lindberg, in opining that the dosage was excessive at 30 mg. per day failed to take into account that the PDR provides that the accepted prescription of Dexedrine for narcolepsy is from 5 mg to 60 mg per day with no time limitation as to its use. His opinion as to excessiveness was based on the medical indications in the PDR for obesity only, not for narcolepsy. Such a dosage for this patient was not excessive in view of her proven diagnosis of narcolepsy. Count XXI concerns the purchase on October 14, 1981, of 1,000 quaalude tablets with regard to which it is alleged that the Respondent failed to maintain proper records justifying purchase and disposal of them as allegedly required by Section 21 USC 1306.04(b). Section 21 USC 1306.04(b) has not been placed in evidence in this proceeding, nor has it been made the subject of judicial notice, pursuant to Section 120.61, Florida Statutes. In any event, the 1,000 quaalude tablets were purchased by the Respondent for use by his wife, Harri Klotz. The Drug Enforcement Administration (DEA) Form 222, required to be maintained by the purchaser of such drugs was maintained by the Respondent and his office manager, and a dispensing record also maintained by them shows that the medication was dispensed upon receipt to Respondent's wife. In fact the drugs were established to be retained in the Respondent's office under lock and key and not physically dispensed to the Respondent's wife at one time, rather they were dedicated to her use, but maintained securely on the Respondent's office premises. Mrs. Klotz was then dispensed 30 tablets at a time in approximately one and one-half to two month intervals, and an additional journal card was established by Ms. Lindblom, the office manager, showing the dates when Mrs. Klotz drew down upon that medication in 30 tablet increments which withdrawals were recorded ads "pills dispensed." Additionally, the 130 methaqualone tablets prescribed for Mrs. Klotz on June 24, 1982, were for the purpose of providing her an additional supply to be used in a light, periodic, controlled manner because the drugs were about to become illegal. Later in August or September, 1982, Ms. Lindblom, when she became aware that the additional prescribing of methaqualone might be illegal, upon advice of Mr. Meiner, the Respondent's counsel, elected to dispose of the remaining quaalude tablets at which time 790 of the original 1,130 tablets dedicated to the use of Mrs. Klotz remained at the Respondent's office and were disposed of. Thus the receipt of 1,000 quaalude tablets was duly recorded in Respondent's record and the 30 tablet dispensations of the medication periodically from October 14, 1981 through June 28, 1982, were recorded in a dispensing record in evidence, which record also reflects the disposal of the 790 unused tablets.

Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses and the pleadings and arguments of counsel, it is, therefore RECOMMENDED: That the Administrative Complaint against the Respondent, Solomon D. Klotz, be DISMISSED except as to the minor violations of Section 458.331(1)(h) and (cc) Florida Statutes, proven with regards to Counts XI and XVIII for which, under the circumstances of this case, no disciplinary action should be taken. DONE and ENTERED this 4th day of May, 1984, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of May, 1984. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Chief Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Sam C. Meiner, Esquire 26 Wall Street Orlando, Florida 32801 Helen C. Ellis, Esquire 1804 Old Fort Drive Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301

Florida Laws (4) 120.57458.331893.03893.05
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs JOHN NKOLO MUBANG, M.D., 18-000606PL (2018)
Division of Administrative Hearings, Florida Filed:Tampa, Florida Feb. 05, 2018 Number: 18-000606PL Latest Update: Nov. 04, 2019

The Issue The issues to be decided are whether Respondent violated portions of chapter 458, Florida Statutes, as alleged in the Administrative Complaints; and, if so, what penalty should be imposed.

Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to this matter, Dr. Mubang was a licensed physician within the State of Florida, having been issued license number ME55171. Respondent’s address of record is 741 Martin Luther King Boulevard West, Seffner, Florida 33584. Since at least March 17, 2010, Dr. Mubang’s practice at 741 Martin Luther King Boulevard has been registered as a pain management clinic with Petitioner. Dr. Mubang is board-certified in geriatric medicine and ambulatory medicine. Dr. Mubang immigrated to the United States from Cameroon, West Africa, to obtain his college education at State University of New York-Buffalo (“SUNY-Buffalo”). Dr. Mubang received a bachelor of arts degree in biology from SUNY-Buffalo. Dr. Mubang attended medical school at Southwestern University School of Medicine in the Philippines. Upon completion of his medical education, Dr. Mubang attended the Medical College of Pennsylvania for clinical rotations. He performed his residency at State University of New York-Brooklyn and Hahnemann University. Dr. Mubang’s license was first issued June 14, 1989, and is valid through January 31, 2020. His license has not been the subject of prior discipline. Dr. Mubang has maintained his Drug Enforcement Agency (“DEA”) Certificate of Registration without revocation, suspension, or other sanction. He has additionally qualified for, and obtained, a separate DEA Certificate of Registration to dispense Suboxone and buprenorphine. This secondary DEA Certificate of Registration requires training in addiction medicine. Dr. Mubang has continuously practiced as the primary care physician for many of his patients. He began his practice in Florida with CIGNA Health Group in one of its managed care clinics at University Mall in Tampa. When CIGNA closed its clinics, Dr. Mubang became employed by Correctional Medical Services (“CMS”), initially at Lake Correctional Facility, and then as the medical director for the Hillsborough County Sheriff’s Office. During his tenure with the Hillsborough County Sheriff’s Office, Dr. Mubang was recognized as the “Medical Director of the Year” for CMS in 1998. After leaving the Hillsborough County Sheriff’s Office, Dr. Mubang joined a practice with Dr. Encarnacion in Seffner, Florida. When Dr. Encarnacion retired, Dr. Mubang acquired the practice. In May 2009, Dr. Mubang received from the Board of Medicine and the Department of Health a publication entitled, “responsible opioid prescribing.” Dr. Mubang learned through his participation in various continuing medical education seminars about certain forms recommended for the treatment of patients suffering from chronic pain. He did not use electronic medical records prior to the dates of treatment charged in these consolidated Administrative Complaints. While in private practice, Dr. Mubang continued to treat patients committed to the State of Florida Juvenile Assessment Centers in Pasco, Pinellas, Sarasota, and Manatee counties. Dr. Mubang’s practice was licensed as a pain management clinic in 2010, despite his having limited formal training or education in pain management. Since initial licensure, his pain management clinic has remained continuously in operation, and has consistently passed all inspections. Pain Management Clinics are subject to annual inspections by DOH pursuant to section 458.3265(4)(a). Dr. Mubang’s Pain Management Clinic has never failed an inspection. DOH Investigator Victor Troupe of the Investigative Services Unit performed inspections of Dr. Mubang’s clinic. The clinic passed inspection. Dr. Mubang’s charged treatment of Patients A.M., B.B., C.C., W.B., and M.H., as alleged in the Administrative Complaint, occurred prior to October 17, 2010, the effective date of revised rule 64B8-9.013. Both parties presented expert witnesses board-certified in pain management to testify as to the standard of care required in this matter. Dr. Robert Guskiewicz testified as a medical expert for Petitioner. Dr. Guskiewicz is board-certified by the American Board of Anesthesiology in anesthesiology with a subspecialty in pain medicine. Dr. Guskiewicz practices as part of a large multispecialty practice in Gainesville, Florida, called Southeast Integrated Medical (“SIMED”). SIMED’s practice areas include neurology, neurosurgery, rheumatology, gynecology, psychology, urology, physiatry, allergy, family practice, and internal medicine. Dr. Guskiewicz is not now, and never has been, a primary care physician. About 40 percent of Dr. Guskiewicz’s practice is performing injections or interventions on patients. Most of the balance is patients on medication management seeking to achieve better functionality. Dr. Guskiewicz defines the standard of care as “what a prudent physician would do with a particular patient in a particular situation at that particular time.” In his practice, Dr. Guskiewicz prescribes 30 mg of oxycodone. Oxycodone is an effective pain medication. According to him, there is no maximum recommended dose for 30 mg of oxycodone. For the purposes of his expert testimony, Dr. Guskiewicz has no knowledge or information regarding Dr. Mubang or his practice. He does not know how big the clinic is where Dr. Mubang practices, who owns it, how many patients are seen each day, how many employees work there, or the types of patients treated there. Dr. Guskiewicz was paid an hourly fee for his expert testimony and preparation for deposition in this matter. Dr. Guskiewicz testified that he did a page-by-page review of the medical records he initially reviewed and those provided for his deposition in lieu of live testimony. Dr. Guskiewicz testified that the records were identical for Patients A.M., B.B., W.B., and M.H., but that the Bates numbers for the records for Patients C.C. and B.D. were not in sync. For Patient B.B., it was apparent at the hearing that Dr. Guskiewicz was in possession of the requisite records, which Respondent argued, had not been reviewed. For Patient M.H., Dr. Mubang argued that Joint Exhibit 6, covering records of treatment from 2010-2012, was not reviewed by Dr. Guskiewicz. Dr. Guskiewicz testified that the records for Patient M.H. were identical. In any event, the records subject to Respondent’s objection concern treatment after the treatment dates at issue in the Administrative Complaint. Only the records concerning the allegations contained in the Administrative Complaints will be considered for purposes of this Recommended Order. Dr. Mubang also raised the issue that Dr. Guskiewicz was not a similarly situated practitioner to Respondent. Dr. Mubang self-identified as practicing in pain management, and he owned and operated a clinic that was registered as a pain management clinic with DOH. Each patient treated by Dr. Mubang signed an Attestation for Pain Management, along with an Agreement for Treatment with Controlled Substances Therapy for Pain. Dr. Mubang acknowledged that if he gave a patient a pain management agreement, he was providing pain management to that patient. If a health care provider is providing evaluation, treatment, or diagnosis for a condition that is not within his or her specialty, a specialist trained in the evaluation, treatment, or diagnosis for that condition shall be considered a similar health care provider, pursuant to section 766.102(8), Florida Statutes. Because Respondent’s care at issue in this case is pain management, which is not specifically within his specialty, Dr. Guskiewicz is considered a similarly situated practitioner to Respondent. Petitioner did not provide Dr. Guskiewicz with any deposition testimony in this action until after his deposition in lieu of live testimony on October 9, 2018. Consequently, the depositions were not considered at the time Dr. Guskiewicz prepared his reports in this action. Dr. Guskiewicz never interviewed any of the patients at issue in this matter; never conducted any physical examination of the patients; and does not know where any of these patients are today. Further, he does not know what their current condition is; whether any of the patients are still receiving treatment for chronic pain; and whether any of the patients are still receiving opioid pain medications for the treatment of chronic pain. During the time periods relevant to these consolidated actions, Florida did not have a prescription drug monitoring database or E-FORCSE. At the time Dr. Guskiewicz authored his November 29, 2011, report, there was not a prescription drug monitoring database in Florida to permit practitioners to verify a patient’s representations about the medications they were taking and who had prescribed them. Dr. Guskiewicz is not a primary care physician, and has never been called upon to cover for a primary care physician who is treating a patient and has an ongoing relationship with that patient. Dr. Guskiewicz agrees that physicians in Florida have an obligation to consider their patients’ subjective complaints of pain and to treat them. Dr. Guskiewicz defines pain management as “treating patients who have chronic pain and provide different modalities of care to increase the functionality and well-being within that patient.” The goal of pain management is to optimize the patient’s functionality, lifestyle, and well-being within his or her family and community. Dr. Guskiewicz acknowledged that a patient coming to him for medical management of his or her pain is looking for an increase in function so he or she can get back to work and participate in normal activities of daily living. Dr. Guskiewicz defines intractable pain as “pain that perpetuates itself no matter what modalities are tried and will always be there. It’s now thought of being a more centralized pain that is basically within the brain itself.” Dr. Thomas Simopoulos testified as a medical expert for Respondent. Dr. Simopoulos is board-certified by the American Board of Anesthesiology in anesthesiology with a subspecialty in pain medicine. Dr. Simopoulos testifies as an expert for the defense more than 90 percent of the time. In the last five years, Respondent’s counsel has paid Dr. Simopoulos $30,000 to $50,000 in expert witness fees. Dr. Simopoulos lives in and practices medicine in Massachusetts. Dr. Simopoulos is not licensed to practice medicine in any other state; and he has never practiced medicine in the State of Florida. Dr. Simopoulos testified that the standard of care at the time material to this case was more regional than national. Dr. Simopoulos educated himself about the regional standard of care in Florida through conversations with his students and through hearing from people at national meetings. Dr. Simopoulos testified that patients have the right to reject a surgical recommendation: “Patients who are younger, in their more productive years, may not want to seek out surgery as a solution, particularly of the spine because it usually means that they’re at risk for having multiple surgeries. So and that even continues today, we try to manage younger folks with more conservative measure [sic], including medications to try to avoid surgery, because we know where that trajectory is going to go.” Dr. Simopoulos admitted that there were no studies at the time material to this case that revealed the exact nature and course of practice in the State of Florida. While Dr. Simopoulos is credited as an expert in anesthesiology and pain management, his reliance on the second- hand accounts from students and conferences he attended to form his opinions about the regional standard of care in Florida, are not as persuasive as the accounts of Dr. Guskiewicz, a physician practicing in the area of anesthesiology and pain management in Florida. Accordingly, Dr. Guskiewicz’s testimony is entitled to greater weight in this proceeding. Dr. Simopoulos also opined that the standard of care can only be violated when a patient is harmed. DOH argued that his definition is inconsistent with the definition in Florida law as contained in section 766.102(1). DOH Investigator Victor Troupe served a subpoena on September 2, 2010, for patient records to include: A.M., B.B., C.C., M.H., and W.B. Investigator Troupe took possession of the original files on that date. He has no reason to believe those patient files had been altered in any way. Investigator Troupe had performed numerous annual inspections of Dr. Mubang’s clinic, and neither found any violations or issued any citations. Investigator Troupe never interviewed Patients A.M., B.B., C.C., M.H., W.B., or B.D. Further, Investigator Troupe has no knowledge or information regarding the present whereabouts of any of those individuals. Finally, he has no information about whether those patients are still receiving opioid analgesic pain medication, even though DOH has access to E-FORCSE for investigative purposes. Drug Definitions Oxycodone is commonly prescribed to treat pain. Roxicodone is a brand name for oxycodone. Oxycodone is a Schedule II controlled substance. Oxycodone will be used throughout this Order, even if the brand name Roxicodone was prescribed. All Schedule II controlled substances have a high potential for abuse and have currently accepted, but severely restricted, medical use in treatment in the United States. Abuse of Schedule II controlled substances may lead to severe psychological or physical dependence. § 893.03(2), Fla. Stat. Fentanyl is a very strong opioid that is prescribed to treat pain and is listed as a Schedule II controlled substance. § 893.03(2)(b), Fla. Stat. Hydromorphone is a Schedule II controlled substance that is commonly prescribed to treat pain. Hydromorphone is commonly prescribed under the brand name Dilaudid. § 893.03(2)(a), Fla. Stat. Methadone is a synthetic opioid prescribed to treat pain. Methadone is a Schedule II controlled substance. § 893.03(2)(b), Fla. Stat. Vicodin and Lortab are brand names for hydrocodone/APAP. Hydrocodone/APAP contains hydrocodone and acetaminophen and is prescribed to treat pain. Hydrocodone in the dosages found in Vicodin is a Schedule III controlled substance. § 893.03(3)(c)4., Fla. Stat. All Schedule III controlled substances have a potential for abuse less than the substances in Schedules I and II. Abuse of Schedule III controlled substances may lead to moderate or low physical dependence or high psychological dependence. § 893.03(3), Fla. Stat. Fiorinal with codeine is the brand name for a drug that contains butalbital and codeine and is commonly prescribed to treat migraine headaches. Butalbital is a Schedule III controlled substance. Codeine is commonly prescribed to treat pain. Codeine is a Schedule II controlled substance. § 893.03(3)(a) and (2)(a), Fla. Stat. Ultram is a brand name for tramadol, an opioid-class narcotic medication prescribed to treat pain. At the time of the events of this case, tramadol was not a controlled substance. Tramadol is currently a Schedule IV controlled substance. § 893.03(4)(b), Fla. Stat. (2018). All Schedule IV controlled substances have a low potential for abuse relative to the substances in Schedule III. Abuse of Schedule IV controlled substances may lead to limited physical or psychological dependence relative to the substances in Schedule III. § 893.03(4), Fla. Stat. Soma is the brand name for carisoprodol. Carisoprodol is a muscle relaxant commonly prescribed to treat muscular pain. Carisoprodol is a Schedule IV controlled substance. § 893.03(4), Fla. Stat. Adderall is the brand name for a drug that contains amphetamine. Adderall is commonly prescribed to treat attention deficit disorder (“ADD”). Adderall is a Schedule II controlled substance. § 893.03(2)(c), Fla. Stat. Xanax is the brand name for alprazolam. Klonopin is the brand name for clonazepam. Valium is the brand name for diazepam. All three drugs are benzodiazepine-class drugs prescribed to treat anxiety, and all three drugs are Schedule IV controlled substances. During the time Respondent treated the five patients, who are the subject of the DOH Case No. 2010-12384, Florida did not have a prescription drug monitoring database. Before E-FORCSE, practitioners had to rely upon a patient’s representation regarding his or her medication history and verify the information by calling identified pharmacies. This “trust but verify” policy was in place at Dr. Mubang’s practice. During the time of Dr. Mubang’s treatment of these patients, he received a letter from Ana M. Viamonte Ros, M.D., the surgeon general for the State of Florida, and Fred Bearison, M.D., the chairman of the Florida Board of Medicine, dated May 13, 2009. That letter enclosed a copy of Responsible Opioid Prescribing, A Physician’s Guide, written by Scott M. Fishman, M.D. The letter advised Dr. Mubang, and others similarly situated, that Dr. Fishman’s book “is a practical guide to Florida’s current standards for the use of controlled substances for the treatment of pain,” based upon the Federation of State Medical Board’s Model Rule, “so it is right on point for Florida practicing doctors.” The book also stated, at page 25: Although Medicare and other institutions have defined what constitutes a physical examination for purposes of coding and reimbursement, exactly what comprises an appropriate or acceptable physical examination for pain is not well-defined, largely because it will differ from case to case. Regulators who expect to see a physical examination as part of the evaluation that leads to appropriate pain care involving controlled substances assume that a basic, if not focused, examination is warranted. The exact components of the examination are left to the judgment of the clinician who is expected to have performed an examination proportionate to the diagnosis that justifies a treatment. Dr. Mubang testified at the hearing, “many point-of- care screens for ‘opiates’ do not reliably detect any opioid other than codeine and morphine, or may not report if levels are below a certain threshold. Therefore, they may give false negative results for semisynthetic and synthetic oil opioid analgesics.” Dr. Mubang received feedback from pharmacists and patients regarding limitations on prescribing imposed on distributors and pharmacies by the DEA, including during the fall of 2010. During the time Dr. Mubang treated the six patients subject to these consolidated administrative actions, there was no upper limit recommended or identified regarding the maximum dosage for opioid analgesics. New patients to Dr. Mubang’s practice have to fill out paperwork, including a patient history. Patients were also required to sign an opioid contract, which mandated patients to use only one pharmacy and required that the patient only obtain medication from Dr. Mubang. Dr. Mubang obtained authorizations for release of medical information to acquire records of prior treating physicians. His office consistently obtained prior records, including MRIs and other diagnostic studies. Dr. Mubang testified that he performed a physical examination of each patient on each office visit. The initial exam was broad, while follow-up examinations were focal. His physical examinations included a review of systems, from head to toe. He stated that each physical examination included a review of the patient’s neurological status and notes whether the patient is oriented to person, time, and place. Dr. Mubang’s practice was to observe patients in his waiting room, and watch each patient as they come to the exam room. This observation is intended to identify things like gait abnormalities, guarding, and posture. Pain patients in Dr. Mubang’s practice are required to complete a Brief Pain Inventory, which he reviews with each patient. Dr. Mubang also reviews past medications with each patient to determine whether the medication has been effective in relieving pain and increasing activities of daily living. He reviews with each patient potential side effects of medication and the risks and benefits of using those medications. Dr. Mubang prepares a progress note for each office visit with a patient. Additionally, he maintains copies of each prescription issued to a patient. The identified treatment plan for each of these six patients was to improve the patient’s functional abilities, to allow them to return to work, and to participate in relationships. Dr. Mubang periodically required patients to submit to a urine immunoassay. This is a presumptive screening test for illicit substances and some other controlled substances. As Dr. Fishman points out on page 61 in his book Responsible Opioid Prescribing, Dr. Mubang was aware that “point-of-care screens for opioids do not reliably detect any opiate other than codeine and morphine.” During the 2010 timeframe, a physician who ordered a urine drug screen was not required to do anything with the results. Further, the requirements of rule 64B8-9.013(3)(d) to monitor patient compliance were not mandatory until after October 17, 2010. Dr. Mubang is aware of the sedative effects of opioids taken with muscle relaxants like Soma. This combination of medication should be dispensed with caution, but if a patient has been taking it for a period of time with no problems, he believes the prescription is appropriate. Dr. Mubang’s approach to changing pain medication, as explored more fully in the following discussion of the six patients subject to this proceeding is consistent, but deserves close scrutiny. He testified that: If the vital signs are stable, you can do what you want, so long as it doesn't have consequences. If you see the visit after this, this patient did not come in with hypertension or they did not end up in the hospital or I was not called at 2:00 in the morning. So it tells you what you're doing is right. See? That's why we do these vital signs. The Patients Each of the patients in this cause completed a two-page questionnaire about his or her pain, titled “brief pain inventory,” during each visit after the initial visit. The pain inventory contained: an anatomical figure for the patient to mark painful areas, 12 questions with a one-to-ten scale for pain level and for activities of daily living, and spaces for the patient to describe the pain in writing. Dr. Mubang’s progress notes for each of the patients consisted of a printed form, containing a similar anatomical figure at the top of the page with most of the rest of the page containing a checklist for “assessment.” Patient A.M. From December 22, 2009, to October 20, 2010, Dr. Mubang provided pain management treatment to Patient A.M., a then 23-year-old female, for lower back pain related to a car accident that occurred several years earlier. Dr. Mubang had first begun treating Patient A.M. while covering for Dr. Luis Azan at Plant City Polyclinic, where he prescribed her 240 30 mg tablets of oxycodone and 120 10 mg tablets of methadone. Dr. Mubang noted that Patient A.M. had been a passenger in the back of the car and was wearing a seatbelt. He noted that Patient A.M. did not lose consciousness, and while she went to the emergency room, she did not have an in-patient stay. On her initial evaluation questionnaire, Patient A.M. reported trying four alternative treatment methods for her pain out of 18 possible treatment options on Dr. Mubang’s checklist form: chiropractic treatment (no relief); muscle injections (no relief); massage (no relief); and pain relievers (some relief). By her own report, Patient A.M. had not tried physical therapy, nerve blocks, or surgery. Patient A.M. had sequential MRI findings from November 7, 2007 (ordered by Dr. Murthy Ravipati), and March 23, 2010 (ordered by Dr. Mubang), which demonstrated a central focal disc protrusion (herniated nucleus pulposus) at L5-S1. On her first visit at his office, Dr. Mubang increased Patient A.M.’s oxycodone from 240 to 270 30 mg tablets per month. He failed to document a rationale for the 30-pill increase. Dr. Mubang’s medical records included Patient A.M.’s medical history and physical examination; diagnostic, therapeutic, and laboratory results; evaluations and consultations; objectives identified; risks and benefits of the treatment ordered; treatments and medications ordered and documented; and instructions and agreements regarding pain management. Dr. Mubang made referrals to consulting physicians, including Dr. Goldsmith (orthopedic) and physical therapy (Select Physical Therapy). From December 22, 2009, to August 27, 2010, Dr. Mubang prescribed 270 30 mg tablets of oxycodone in combination with 120 10 mg tablets of methadone to Patient A.M. monthly. In ten months, Patient A.M. received 3,870 pain pills from Dr. Mubang. In order to take the pain medication as prescribed, Patient A.M. would have to take 13 pain pills per day. By comparison, Dr. Mubang’s expert, Dr. Simopoulos, testified that in his practice the most 30 mg of oxycodone that he ever prescribed was six tablets per day, or 180-200 tablets per month. Petitioner’s expert, Dr. Guskiewicz, testified that in his practice the most 30 mg of oxycodone that he ever prescribed was five per day, or 150 tablets. In addition to the pain medication, Dr. Mubang prescribed 90 350 mg tablets of Soma to Patient A.M. per month. On August 2, 2010, Dr. Mubang ordered a urine drug screen for Patient A.M. The drug screen was positive for benzodiazepines and negative for methadone. If a patient tests negative for a prescribed medication, the physician should consider the possibility that the patient is not taking the drug and, instead, is diverting it. Given Patient A.M.’s negative test for methadone, Dr. Mubang should not have continued to prescribe methadone to her, or at least should have questioned her about her usage of the prescribed drug. Despite the aberrant test result, Dr. Mubang continued to prescribe potentially lethal doses of oxycodone, methadone, and Soma to Patient A.M. Further, from December 22, 2009, through August 27, 2010, Dr. Mubang did not perform nor did he document performing a complete and adequate physical examination or medical history to justify his prescribing of potentially lethal doses of methadone, oxycodone, and Soma to Patient A.M. From December 22, 2009, through August 27, 2010, Dr. Mubang did not diagnose Patient A.M. with intractable pain prior to prescribing potentially lethal doses of methadone, oxycodone, and Soma to Patient A.M. To meet the standard of care, Dr. Mubang should have immediately reduced the amount of medication that he prescribed to Patient A.M. Additionally, he should have tried to determine the root cause of Patient A.M.’s pain. Dr. Mubang should have followed up on his ordering of alternative treatment modalities, such as physical therapy, and if Patient A.M. refused to follow his instructions, he should have discharged Patient A.M. While Dr. Mubang’s records are at times difficult to read, some were legible enough for review by the two experts who offered opinions in this matter. On the whole, however, the medical records for Patient A.M. were inadequate (and some of them were actually illegible) to provide complete information to either Dr. Mubang or another reviewing physician or investigator. Patient B.B. From March 25, 2010, to August 23, 2010, Respondent provided pain management treatment to Patient B.B., a then 25- year-old female. Patient B.B. initially visited Dr. Mubang on March 25, 2010, with a history of cervical spinal fusion in 2003 following a motor vehicle accident. Dr. Mubang’s Initial Evaluation documented a thorough review of systems, including skin; HEENT (head, eyes, ears, nose, and throat); neurological; and musculoskeletal. Simultaneously, Dr. Mubang and the patient completed a Pain Questionnaire documenting the location and severity of Patient B.B.’s pain and other treatment modalities, which had been tried, but failed (surgery, braces, chiropractic, physical therapy, TENS, and massage). On her initial visit with Dr. Mubang, Patient B.B. reported having neck, shoulder, and upper back pain. Dr. Mubang noted on his initial range of motion assessment that Patient B.B. had no thoraco-lumbar spine pain. Patient B.B. never indicated on her brief pain inventories that she had pain radiating down the leg. Instead, she consistently marked pain in the neck, radiating down the right arm, and pain in the middle back. After the initial visit, Dr. Mubang recorded that Patient B.B. had lower back pain by noting “LBP & radiculopathy” with a line drawn down the leg of the anatomical figure. Dr. Mubang’s explanation for the discrepancy between his notation on the anatomical figure and Patient B.B.’s notation was that the patient was noting pain, but that he was noting tenderness. He did not explain the difference. As discussed below, this same inconsistency appears frequently in many of the patients’ records. Dr. Mubang’s offered explanation for the discrepancy between his records and the patient-generated records is not credible. From March 25, 2010, to August 23, 2010, Dr. Mubang prescribed 240 30 mg tablets of oxycodone in combination with 60 2 mg tablets of Xanax to Patient B.B. monthly. From March 25, 2010, to May 20, 2010, Dr. Mubang also prescribed 120 350 mg tablets of Soma to Patient B.B., in addition to the oxycodone and Xanax each month. To justify the amount of Xanax he prescribed to Patient B.B., Dr. Mubang relied on an anxiety checklist questionnaire completed by Patient B.B. In his practice, if a patient marked five to six of the criteria on his anxiety checklist, Dr. Mubang would prescribe the patient Xanax. For Patient B.B., on three of his five progress notes, Dr. Mubang checked the box for anxiety. Other than that, there is no annotation or documentation by Dr. Mubang concerning Patient B.B.’s anxiety. From March 25, 2010, through August 23, 2010, based on Patient B.B.’s history and physical findings, Dr. Mubang prescribed potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. in excessive quantities and without sufficient justification. From March 25, 2010, through August 23, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing of potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. From March 25, 2010, through August 23, 2010, Dr. Mubang failed to diagnose Patient B.B. with an anxiety disorder, which would have supported his prescribing of Xanax to Patient B.B. From March 25, 2010, through August 23, 2010, Dr. Mubang did not diagnose Patient B.B. with intractable pain prior to prescribing potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. To meet the standard of care, Dr. Mubang should have done more to treat Patient B.B.’s underlying source of pain through referrals for physical therapy or orthopedics. Depending on the particular findings, he should have tried intervention care to relieve Patient B.B.’s pain instead of relying solely on medication management, particularly, excessive amounts of oxycodone. Patient B.B., as a relatively young patient, would have benefited from more aggressive physical therapy, massage therapy, and other treatment modalities to keep her off of addictive pain medication as much as possible. Dr. Mubang attempted, in part, to justify his excessive amounts of medications, based upon The Super Saver pharmacy profile for Patient B.B., which confirms that this patient was receiving the same quantities and combination of medications from the prior physician, Ibem R. Borges, M.D. He also cites rule 64B8-9.013 (2003) to support the heavy prescribing of medications, which indicates the Board of Medicine will not judge the validity of prescribing, “based upon the quantity and chronicity,” and that a “physician’s conduct will be evaluated to a great extent by treatment outcome.” He argues that Petitioner failed to introduce any evidence to establish Patient B.B. suffered any adverse effect from Dr. Mubang’s treatment. Patient C.C. From April 29, 2010, to May 28, 2012, Dr. Mubang provided pain management treatment to Patient C.C., a then 32-year-old female. At her initial evaluation, Patient C.C. reported having lower back pain and left knee pain. On her subsequent brief pain inventories, Patient C.C. consistently marked pain at the middle of the lower back and pain at the left knee. Almost identical to Patient B.B., Dr. Mubang’s progress notes for Patient C.C. note “LBP & radiculopathy” with a line drawn down the leg of an anatomical figure indicating pain radiating down the leg. Contained in Respondent’s records were notes from two prior treating providers, Drs. David Herson and Marc Weinstein. On a note dated February 27, 2007, Dr. Herson noted that Patient C.C.’s cervical and lumbar range of motion was within normal limits, and he noted no tenderness to palpation of the lumbar spine. Dr. Herson recommended epidural injections to Patient C.C. for the left knee pain. Dr. Herson prescribed Patient C.C. 30 tablets of Ultram for her pain. On a note dated March 1, 2007, Dr. Weinstein noted that “MRI scans of her cervical and lumbar spine and left knee were performed and show no significant abnormalities that would require surgery.” From April 29, 2010, to August 19, 2010, Dr. Mubang prescribed 290 30 mg tablets of oxycodone in combination with 180 10 mg tablets of methadone to Patient C.C. monthly. In a period of four months, Patient C.C. received 2,350 pain pills from Dr. Mubang, which equates to a daily prescription of 15.5 pills. In addition to addictive pain medication, Dr. Mubang also prescribed 60 2 mg tablets of Xanax to Patient C.C. per month. Opioids and benzodiazepines in combination increase the risk of respiratory depression, which can be fatal. On April 29, 2010, and May 27, 2010, Dr. Mubang added 90 350 mg tablets of Soma to the potentially lethal cocktail of medications he prescribed to Patient C.C. Dr. Mubang failed to document his rationale for starting and stopping Soma. On April 29, 2010, as part of her initial evaluation with Dr. Mubang, Patient C.C. reported to him that her current medications were oxycodone, methadone, Xanax, and Soma. On April 29, 2010, Dr. Mubang ordered a urine drug screen for Patient C.C. The drug screen was positive for opiates, oxycodone, and benzodiazepines, but was negative for methadone. Opiates and opioids are discernibly different categories of drugs. Opiates are morphine derivatives. Opioids are synthetic opiates. No medications Patient C.C. reported taking were opiates. The standard of care required Dr. Mubang to inquire as to the reasons behind the aberrant drug test result and adjust Patient C.C.’s medications accordingly. In his 2012 deposition, Dr. Mubang speculated that he may have consulted Patient C.C. about the drug test and that maybe she ran out of medication. He could not tell from his records if he discussed the results with Patient C.C. or the reason for the aberrant test result because his records lacked any such information. At the final hearing in this matter, Dr. Mubang raised for the first time the defense that the urine drug screen he used at that time was incapable of testing for methadone. He also argued that if a patient is taking oxycodone and methadone together, then either one, both, or neither may show up positive on a urine drug screen due to “tolerance” and methadone’s interaction with oxycodone and with the NMDA (the amino acid neuro receptor that increases the tolerance of oxycodone by interacting with methadone). This was a clear misunderstanding by Dr. Mubang of his expert’s testimony regarding the use of methadone in pain management. Dr. Mubang testified many times at hearing that methadone has a tolerance effect on oxycodone, which causes a physician to increase the dose of oxycodone. Respondent’s testimony was incongruent with the description given by his expert witness. Dr. Simopoulos explained that methadone can antagonize NMDA receptors, which can help some patients who have a tolerance to oxycodone. However, Dr. Simopoulos’s testimony regarding NMDA did not relate to the ability to detect methadone in a urine drug screen. Despite the negative test result for methadone, during the same visit, Dr. Mubang prescribed 180 10 mg tablets of methadone to Patient C.C. No questions of whether Patient C.C. may have diverted her methadone or notations of such were in the doctor’s notes. Dr. Mubang failed to order a second urine drug screen for Patient C.C. until ten months later on February 2, 2011. The second test was also negative for the prescribed medication methadone. From April 29, 2010, through August 19, 2010, based on Patient C.C.’s presentation, Dr. Mubang prescribed potentially lethal doses of oxycodone, methadone, Xanax, and Soma to Patient C.C. inappropriately, in excessive quantities, and without justification. From April 29, 2010, through August 19, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing potentially lethal doses of oxycodone, methadone, Xanax, and Soma to Patient C.C. Dr. Mubang did not diagnose Patient C.C. with intractable pain prior to prescribing to the patient the potentially lethal doses of oxycodone, methadone, Xanax, and Soma. To meet the standard of care, Dr. Mubang should not have prescribed such large amounts of pain medication to Patient C.C., a patient who did not have a significant pathology for pain. Instead, he should have pursued other treatment modalities, such as injections and physical therapy. Patient W.B. From December 13, 2008, to February 18, 2011, Dr. Mubang provided pain management treatment to Patient W.B., a then 52-year-old male. On or about April 20, 2008, prior to visiting Dr. Mubang, Patient W.B. presented to the emergency room at Sarasota Memorial Hospital after being hit by a “slow moving vehicle,” while riding his bicycle. The emergency room physician diagnosed Patient W.B. with a bruise of the left knee and left hip and prescribed an unknown quantity of 7.5 mg Lortab to Patient W.B. Patient W.B. then visited Physician’s Group, LLC, in Sarasota for follow-up care on April 20, May 28, November 11, and December 2, 2008. On May 28, 2008, Patient W.B. reported to a provider at Physician’s Group, LLC, that he had taken Dilaudid from a friend. On November 11, 2008, Patient W.B. saw Dr. Frederic Sonstein. Dr. Sonstein noted that Patient W.B. missed a scheduled appointment because he was incarcerated. While incarcerated, Patient W.B. was treated with Flexeril and Ultram. Dr. Sonstein recommended referral to a pain management specialist and prescribed Vicodin for pain control. A November 24, 2008, MRI report of Patient W.B.’s lumbar spine was unremarkable. On December 13, 2008, Patient W.B. came to Dr. Mubang and reported having pain in his neck and shoulders, with pain radiating down both arms. In contrast to Patient W.B.’s report, on his initial range of motion evaluation, Dr. Mubang did not document any findings under cervical spine. Instead, he noted lumbar spine pain with radiculopathy. On his initial evaluation questionnaire, Patient W.B. reported only having tried one alternative treatment method for his pain, “braces or cast.” By his own report, Patient W.B. had not tried any of the other alternative treatment options on Dr. Mubang’s checklist form, such as physical therapy, chiropractic, muscle injections, or surgery. Despite the minimal objective findings in Patient W.B.’s history, Dr. Mubang began to prescribe escalating amounts of oxycodone to Patient W.B. On December 13, 2008, Dr. Mubang prescribed 120 30 mg tablets of oxycodone to Patient W.B. Then, he increased the amount of oxycodone he prescribed to Patient W.B. over the following monthly visits as follows: 150, 180, 210, 210, 240, 240, and ultimately settling at 270 30 mg tablets of oxycodone per month. From December 13, 2008, to August 24, 2010, Dr. Mubang prescribed Patient W.B. 4,050 30 mg tablets of oxycodone. On July 11, 2009, in addition to oxycodone and Soma, Dr. Mubang added Xanax and Fiorinal with codeine to Patient W.B.’s monthly prescription regimen. Like with Patient B.B., Dr. Mubang prescribed Xanax to Patient W.B. based on Patient W.B.’s answers to his checklist anxiety questionnaire. On July 11, 2009, Dr. Mubang saw Patient W.B. and renewed his medication. He scheduled Patient W.B. to return on August 9, 2009; however, Patient W.B. missed the appointment. Patient W.B. next visited Dr. Mubang two months later, on October 13, 2009. Dr. Mubang failed to document the reason for Patient W.B.’s three-month absence. He failed to document if Patient W.B. continued to receive pain medication from another source. He did not note whether Patient W.B. experienced withdrawal symptoms without his oxycodone for two months or how Patient W.B. managed his pain without oxycodone for two months. Dr. Mubang admitted during the hearing that, “[i]t is important to me to know why he misses visits. And you're right. Your point is well-taken.” Dr. Mubang’s own controlled substance agreement, which was executed by Patient W.B., explicitly stated that renewals are contingent on keeping scheduled appointments. Despite the unexplained absence, on October 13, 2009, he renewed Patient W.B.’s prescriptions for 270 tablets oxycodone, 30 tablets Soma, 60 tablets Xanax, and 90 tablets of Fiorinal with codeine. Dr. Mubang should not have restarted Patient W.B. at the same high dosage of oxycodone that he had previously prescribed, as it was potentially fatal. On November 10, 2009, Dr. Mubang ordered a urine drug screen for Patient W.B. The drug screen was positive for cocaine and hydromorphone. The drug screen was negative for the prescribed medications Soma (carisoprodol) and Xanax (alprazolam). Based upon the November 10, 2009, drug screen result, the standard of care required Dr. Mubang to refer Patient W.B. to a drug treatment center. When questioned about the positive cocaine result, Dr. Mubang’s expert, Dr. Simopoulos, testified, “That’s the part where this patient has a substance abuse disorder, obviously.” Dr. Simopoulos opined that, “if you are going to continue prescribing in this case, because the patient has duel diagnoses, you would want the input of a psychiatrist for this case.” Patient W.B. next visited Dr. Mubang approximately three months later on February 9, 2010. Again, Dr. Mubang failed to document the reason for the absence. At the February 9, 2010, visit, Dr. Mubang ordered a urine drug screen for Patient W.B., which returned completely negative results. After a multi-month absence and with a completely negative urine drug screen, Patient W.B. would have been opioid negative. In his 2012 deposition, Dr. Mubang theorized that the completely negative result may have been because Patient W.B. drove himself to his appointment and Dr. Mubang instructed his patients not to drive while on medication. This made little sense. Despite the completely negative result and unexplained absence, Respondent prescribed Patient W.B. 270 tablets of oxycodone, 30 tablets of Soma, 60 tablets of Xanax, and 90 tablets of Fiorinal with codeine. Again, Dr. Mubang should not have restarted Patient W.B. at the same high dosage of oxycodone that he had previously prescribed, as it was potentially fatal. Despite prescribing 270 tablets of oxycodone per month to Patient W.B., or nine pills per day, Dr. Mubang testified at hearing that, “[i]f I give them what they call ‘breakthrough medications,’ like oxycodone, all these, they'll tell you some days they take it, some days they don't take it.” Dr. Mubang was aware that Patient W.B. did not require nine oxycodone tablets per day and that the amount of oxycodone he prescribed to Patient W.B. was not justified. The foregoing pattern of unexplained absence and completely negative urine drug screen result, followed by Dr. Mubang renewing prescriptions, was repeated in November 2010. From December 13, 2008, through November 10, 2010, Dr. Mubang prescribed potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. inappropriately, in excessive quantities, and without justification. From December 13, 2008, through November 10, 2010, Dr. Mubang neither performed nor did he document performing a complete and adequate physical examination or medical history to justify his prescribing of the potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. From December 13, 2008, through August 24, 2010, Respondent did not diagnose Patient W.B. with intractable pain prior to prescribing potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. To meet the standard of care, Dr. Mubang should have discontinued prescribing the amount of medication that he prescribed to Patient W.B. based on the minimal findings in Patient W.B.’s history and the minimal changes on examination. In addition, Dr. Mubang should have referred Patient W.B. to a drug treatment center. Patient M.H. From January 10, 2005, to May 29, 2012, Dr. Mubang provided pain management treatment to Patient M.H., who first visited him as a 29-year-old female, suffering lower back pain. Prior to seeing Dr. Mubang, on March 24, 2004, Patient M.H. visited Dr. Edward Jacobson. Dr. Jacobson noted that Patient M.H. had been in a car accident on February 21, 2004, and that Patient M.H. was complaining of headaches. He prescribed 15 tablets of Vicodin to her. On January 10, 2005, Patient M.H.’s first visit with Dr. Mubang, he prescribed her 60 tablets of Vicodin. On January 21, 2005, Dr. Mubang added clonazepam and Adderall to Patient M.H.’s medication regimen. Dr. Mubang’s note for the January 21, 2005, visit does not make any mention of Patient M.H. suffering from an anxiety disorder or ADD that would justify his use of clonazepam or Adderall, save for a simple “ADD” noted in the assessment/plan portion of the form. Dr. Mubang should have referred Patient M.H. to a psychiatrist for diagnostic confirmation of ADD before automatically prescribing (or refilling) the Adderall prescription. From June 15, 2005, to March 7, 2007, Dr. Mubang prescribed Valium in combination with clonazepam to Patient M.H. monthly. Then on March 23, 2009, he discontinued clonazepam and started Patient M.H. on 90 2 mg tablets of Xanax. Dr. Mubang neglected to document a justification for prescribing Patient M.H. benzodiazepine-class drugs, or for prescribing her a combination of two different benzodiazepine- class drugs, or for the changes he made to the benzodiazepines he prescribed. On January 6, 2009, Patient M.H. reported having lower back pain from a car accident in 2003. Dr. Mubang noted that Patient M.H. was the driver of a car that was rear-ended. He also noted that Patient M.H. did not lose consciousness during the accident and did not go to the emergency room. At the January 6, 2009, visit, Patient M.H. reported trying three alternative treatment methods for her pain. By her own report, Patient M.H. had not tried any of the other 18 alternative treatment options on Dr. Mubang’s checklist form, such as physical therapy, muscle injections, or surgery. In 2009, for unexplained reasons, Dr. Mubang began significantly increasing Patient M.H.’s opioid pain medication. In January 2009, he increased Patient M.H.’s Vicodin from 60 to 90 tablets per month, then in July 2009 from 90 to 120 tablets per month. On October 19, 2009, Dr. Mubang prescribed Patient M.H. ten 50 mcg patches of fentanyl in combination with 120 tablets of Vicodin. A 50 mcg fentanyl patch is intended to last for 72 hours; so, a prescription of ten patches is intended to last one month. Fentanyl is a very strong opioid. Based on Patient M.H.’s experience with opioids, Dr. Mubang’s prescribing fentanyl to Patient M.H. was potentially lethal. On November 16, 2009, Dr. Mubang discontinued fentanyl and started Patient M.H. on 90 15 mg tablets of oxycodone, which he increased to 120 tablets the next month. Dr. Mubang prescribed the oxycodone in combination with 120 tablets of Vicodin. At hearing, Dr. Mubang could not tell from his notes and was, therefore, unable to explain his rationale as to why he prescribed fentanyl to Patient M.H., or why he discontinued the fentanyl and started Patient M.H. on oxycodone. The limited documentation that was included in Dr. Mubang’s records contradicted his course of treatment, as he routinely documented that Patient M.H.’s pain was a two out of ten with medication. From March 8, 2010, to June 28, 2010, Dr. Mubang added and then discontinued prescribing Soma to Patient M.H. His records do not contain any justification for starting Patient M.H. on Soma or for stopping Soma. On May 3, 2010, Dr. Mubang ordered a urine drug screen for Patient M.H. The urine drug screen result was negative for the prescribed medication oxycodone. The standard of care required Dr. Mubang to ask about the reason for the aberrant result to determine whether she was taking the medications or diverting them. Depending upon Patient M.H.’s answer, he should have ordered a repeat urine drug screen at the following visit. Despite the negative test, Dr. Mubang continued to prescribe potentially lethal doses of oxycodone and Vicodin to Patient M.H. From January 10, 2005, through August 23, 2010, Dr. Mubang prescribed potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone to Patient M.H. inappropriately, in excessive quantities, and without justification. From January 10, 2005, through August 23, 2010, Dr. Mubang did not diagnose Patient M.H. with ADD or any other clinical indication to support his prescribing Adderall to Patient M.H. From January 10, 2005, through August 23, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing of the potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone to Patient M.H. Dr. Mubang did not diagnose Patient M.H. with intractable pain prior to prescribing to the patient the potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone. To meet the standard of care in his treatment of Patient M.H., Dr. Mubang should not have prescribed fentanyl to Patient M.H. without sufficient medical justification, as doing so was life threatening. Respondent should have referred Patient M.H. to specialists, such as orthopedics, physical therapy, and psychiatry. To the extent Dr. Mubang documented referrals to specialists, he should have followed up on his ordering of referrals to minimize the amount of medications he provided to Patient M.H., instead of escalating the amounts of pain medicine he prescribed. Patient B.D. From November 11, 2010, to November 8, 2012, Dr. Mubang provided pain management treatment to Patient B.D., a then 24- to 26-year-old female. In addition to lower back pain, Patient B.D. was also diagnosed with fibromyalgia. Dr. Mubang’s medical records for Patient B.D. contain a note from Dr. Indira Koshy, a prior treating provider, for a visit on August 24, 2010, in New York. Dr. Koshy noted that Patient B.D. was “entering rehab” and that Patient B.D. has seizures when she does not take her medications. Dr. Koshy’s note indicates potential for doctor shopping. At no point during his treatment of Patient B.D. did Dr. Mubang address the note from Dr. Koshy, specifically; Patient B.D.’s entry into rehabilitation; Patient B.D.’s seizures when she did not take her medications; or Patient B.D.’s potential for doctor shopping. Dr. Mubang previously treated Patient B.D. at Care Point Medical Center as a covering physician. He testified that when covering as a physician he provided “continuation of care” and that his practice was not to change a patient’s medication. Despite his testimony, when covering at Care Point Medical Center, Dr. Mubang increased Patient B.D.’s oxycodone from 210 tablets per month to 240 tablets per month. Then, on November 11, 2010, when Patient B.D. visited his practice, Dr. Mubang decreased her oxycodone from 240 to 180 tablets. As discussed below, this decrease came after he received notice of Petitioner’s investigation. From November 11, 2010, until May 24, 2012, Dr. Mubang prescribed Patient B.D. 180 30 mg tablets of oxycodone, 30 or 60 10 mg tablets of methadone, 60 350 mg tablets of Soma, and 30 0.5 mg to 2 mg tablets of Xanax monthly. On June 21, 2012, Dr. Mubang changed Patient B.D.’s prescribed muscle relaxant from Soma to baclofen; and on July 19, 2012, he changed Patient B.D.’s prescribed anxiolytic medication from 60 0.5 mg tablets of Xanax to 60 2 mg tablets of clonazepam. Dr. Mubang did not document any justification for the foregoing medication changes. From September 13, 2012, until November 8, 2012, Dr. Mubang prescribed 112 8 mg tablets of Dilaudid, 28 10 mg tablets of methadone, and 60 tablets of clonazepam to Patient B.D. monthly. On June 23, 2011, Dr. Mubang performed a urine drug screen on Patient B.D. The drug screen was negative for benzodiazepines, even though he prescribed Xanax to Patient B.D. The urine drug screen was positive for methadone, despite Dr. Mubang’s testimony that his urine drug screen could not detect methadone. On December 8, 2011, and June 21, 2012, Dr. Mubang performed urine drug screens on Patient B.D. Both drug screens were negative for the prescribed medication methadone. The standard of care required a reasonably prudent physician to question the patient about the aberrant urine drug screens results and cease prescribing methadone to a patient whose urine drug screen was negative for the drug. Despite the negative test results, Dr. Mubang continued to prescribe methadone to Patient B.D. From November 11, 2010, through November 8, 2012, Dr. Mubang neither performed nor documented performing an adequate history or physical examination to justify his prescribing of the potentially lethal controlled substances to Patient B.D. From November 11, 2010, through November 8, 2012, based on Patient B.D.’s history and physical findings, Dr. Mubang’s prescribing of the controlled substances to Patient B.D. was excessive and without justification. From June 23, 2011, through November 8, 2012, Dr. Mubang failed to address Patient B.D.’s aberrant urine drug screen results. To meet the standard of care in his treatment of Patient B.D., Dr. Mubang should not have prescribed the quantity and combination of drugs he prescribed to Patient B.D. He should have referred Patient B.D. for a rheumatology consult to confirm or rule out fibromyalgia and other diseases. He should have offered more physical therapy, and other, non-opioid modalities of care, and he should have routinely followed up with Patient B.D. to ensure that she was complying with his orders. Dr. Mubang testified that Soma was part of the “holy trinity,” which is a slang drug term used to refer to the prescription combination of oxycodone, a benzodiazepine, and Soma. He prescribed the “holy trinity” to five of the six patients in this cause. Dr. Mubang’s Medical Records Dr. Mubang’s medical records for the six patients, who are the subjects of the Administrative Complaints, were generally lacking in specificity to justify the level of his prescribing. Some examples common to the patients at issue illustrate these shortcomings. For each visit for each of the patients, Dr. Mubang noted that the patient had straight leg raise pain at 30 degrees, even though he testified that a patient can have straight leg raise pain at 15, 20, 30, or 45 degrees. Maybe this was a coincidence, but more credibly it is a pattern of sloppiness or autofill by the doctor. Also, for each patient, Dr. Mubang routinely drew a line down one leg of the anatomical figure on his progress notes indicating radiculopathy, regardless of where the patient reported pain. At hearing, on multiple occasions, Dr. Mubang could not determine his rationale for changing a patient’s medication regimen, based on his progress notes. His own expert, Dr. Simopoulos, testified that, “there's not much rationale on the plans in--in Dr. Mubang's notes in general.” Dr. Mubang tried to justify the lack of documented rationale by explaining that if a subsequent treating physician needed to know why he made medication changes, the physician would just call him and ask. While this should be true in an ideal world, his attempted justification is contrary to the purpose of medical records, which is continuity of care. No doctor, regardless of his education and experience, can be expected to remember every detail about every patient when he only sees the patient periodically. The medical record and doctor’s notes comprise his guide to ensuring the patient receives continuous, appropriate care. In addition to lacking in rationale, both experts were unable to read some of Dr. Mubang’s handwritten notes due to legibility. His own expert testified that, “The hardest part about these records is, obviously, how legible they are. I wish they were more legible.” Dr. Mubang’s medical records were inadequate for all six of the patients at issue here. Dr. Mubang’s Defenses Dr. Mubang passionately testified at hearing that he practices addiction medicine, that he prescribes Suboxone, and that his goal is to titrate patients’ medication. However, Dr. Mubang’s interest in addiction medicine and Suboxone is a recent phenomenon. In his 2012 deposition, he did not mention practicing addiction medicine, and the word Suboxone does not even appear in that deposition. Dr. Mubang titrated the medication he prescribed for four of the six patients in this cause. His reasoning for titrating the patients’ medication changed from his deposition testimony to his hearing testimony. In his 2018 deposition, he testified that he reduced the patients’ pain medication because the patients’ conditions were improving, and his goal was to titrate the medication. At hearing, he asserted the theory that he changed his prescribing practices because pharmacies contacted him and told him that they would no longer fill prescriptions written for such large quantities. The first of these is based upon a consideration of quality of care, while the second is based upon the practical reality of changing pharmacy practices as the dangers of over-prescribing opiates started to become more prevalent in the eyes of health professionals and regulators. On September 2, 2010, Investigator Victor Troupe personally served Dr. Mubang with a notice of investigation and a subpoena for medical records for Patients A.M., B.B., C.C., W.B., and M.H., among others. Following receipt of the notice of investigation, the doctor radically changed his prescribing practice for the patients in this cause. For ten months, Dr. Mubang prescribed Patient A.M. 270 tablets of oxycodone. Then on September 24, 2010, three weeks after being served by Petitioner, Respondent reduced Patient A.M.’s prescription of oxycodone from 270 tablets to 210, and then from 210 tablets to 180. For five months, Dr. Mubang prescribed Patient C.C. 290 tablets oxycodone. Then on September 9, 2010, Respondent reduced Patient C.C.’s prescription of oxycodone from 290 tablets to 210. At the patient’s next visit on January 5, 2011, Dr. Mubang reduced the patient’s prescription of oxycodone from 210 tablets to 180. Dr. Mubang also reduced Patient C.C.’s methadone. For five months, he prescribed 180 10 mg tablets of methadone to Patient C.C., but he reduced that number first to 60 tablets, then to 30, then discontinued the prescription. Further, in a matter of three visits, the doctor went from prescribing Patient C.C. 470 pain pills per month to 180 tablets. For ten months, Dr. Mubang prescribed Patient W.B. 270 tablets of oxycodone. Then on November 6, 2010, Patient W.B.’s first visit after the doctor received notice of the investigation, he reduced Patient W.B.’s prescription of oxycodone to 240 tablets, then to 210 on the next visit. For five months, Dr. Mubang prescribed Patient B.D. 240 tablets of oxycodone. Then on November 11, 2010, Patient B.D.’s first visit with the doctor after he had received notice of the investigation, he reduced Patient B.D.’s prescription of oxycodone to 180 tablets. The logical explanation for Dr. Mubang’s sudden reduction in amounts of pain medication prescribed is that the Petitioner’s notice of investigation triggered him to change his prescribing practice. The notice of investigation might have been his “eureka” moment or it might have served as a wake-up call to him concerning his prior over-prescribing practices. The evidence clearly and convincingly demonstrates that Dr. Mubang used little critical medical judgment when prescribing dangerous controlled substances to the patients in this matter. His diagnoses were based solely on patient report, and his primary tool for treating these patients was the prescription of controlled substances without first exhausting less harmful treatment modalities or combining lower doses of controlled substances with his patients seeking other treatment modalities.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order: finding that Respondent, John Nkolo Mubang, M.D., violated sections 458.331(1)(nn), 458.331(1)(q), 458.331(1)(t), 458.331(1)(m), and 458.331(1)(cc), Florida Statutes, as charged in Petitioner’s Administrative Complaints; and revoking Dr. Mubang’s Florida medical license. DONE AND ENTERED this 25th day of June, 2019, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of June, 2019. COPIES FURNISHED: Chad Wayne Dunn, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Dale R. Sisco, Esquire Sisco-Law 1110 North Florida Avenue Tampa, Florida 33602 (eServed) Zachary Bell, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Claudia Kemp, JD, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 (eServed) Louise Wilhite-St Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed)

Florida Laws (12) 120.569120.57120.6820.43456.072456.079456.50458.326458.3265458.331766.102893.03 Florida Administrative Code (5) 28-106.21764B8-8.00164B8-8.001164B8-9.00364B8-9.013
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DACCO BEHAVORIAL HEALTH, INC.; OPERATION PAR, INC.; AND ASPIRE PARTNERS, INC. vs DEPARTMENT OF CHILDREN AND FAMILIES, 17-006655RU (2017)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Dec. 11, 2017 Number: 17-006655RU Latest Update: Mar. 14, 2019

The Issue The issue in this case is whether Florida Administrative Code Emergency Rule 65DER17-2 (the “Emergency Rule”) constitutes an invalid exercise of delegated legislative authority as defined in section 120.52(8), Florida Statutes. (Unless specifically stated otherwise herein, all references to Florida Statutes will be to the 2017 version.) More specifically, on September 19, 2017, the Florida Department of Children and Families (the “Department”), published the Emergency Rule, which dealt with the need for and licensing of new methadone medication-assisted treatment centers for persons dealing with opioid addiction. Pursuant to the Emergency Rule, the Department decided which providers would receive approval notices to submit licensure applications in certain counties based on the order in which complete and responsive applications were received by the Department. A number of parties are challenging the validity of the Emergency Rule.

Findings Of Fact Parties and Standing Respondent, the Department, is the state agency responsible for licensing providers of care in methadone medication-assisted treatment facilities. It is the agency, which promulgated the Emergency Rule. Petitioner, Dacco Behavioral Health, Inc. (“Dacco”), is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Dacco submitted three applications for licensure under the Emergency Rule. Its applications were not approved by the Department. Dacco timely filed an administrative challenge to its denied applications. Dacco has standing in this proceeding. Petitioner, OPI, is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. OPI submitted six applications for licensure under the Emergency Rule. None of its applications were approved by the Department. OPI timely filed an administrative challenge to its denied applications. OPI has standing in this proceeding. Petitioner, Aspire Health Partners, Inc. (“Aspire”), is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Aspire submitted two applications for licensure under the Emergency Rule. Neither of its applications was approved by the Department. Aspire timely filed an administrative challenge to its denied applications. Aspire has standing in this proceeding. Intervenor, CRC, is a Delaware limited liability company registered to do business in Florida. CRC is currently licensed to operate a methadone medication-assisted treatment clinic in Florida. CRC submitted 16 applications for licensure under the Emergency Rule. Its applications were not approved by the Department. CRC timely filed an administrative challenge to its denied applications. CRC has standing to intervene in this proceeding. Intervenor, Riverwood Group, LLC (“Riverwood”), is a Delaware limited liability company authorized to do business in Florida. Riverwood is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Riverwood submitted six applications for licensure under the Emergency Rule. Its applications were not approved by the Department. Riverwood timely filed an administrative challenge to its denied applications. Riverwood has standing to intervene in this proceeding. Intervenor, Symetria, is a Florida limited liability company whose parent company is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Symetria submitted 11 applications for licensure under the Emergency Rule. One of its applications was approved; the other 10 were not approved by the Department. Symetria did not file an administrative challenge to the denial of its applications. Opposition to Symetria’s standing was raised by Intervenors appearing in support of Respondent. Symetria was allowed to participate at final hearing pending adequate proof of standing. Symetria did not prove its standing at final hearing. Symetria does not have standing in this proceeding on behalf of Petitioners as it does not satisfy the two-prong test announced in Agrico Chemical Company v. Department of Environmental Regulation, 406 So. 2d 478 (Fla. 1st DCA 1978). (After entry of this Final Order, Symetria will be stricken from the style of the case.) It should be noted that Symetria apparently never received notice as to its denied applications and may have challenged those denials, if notices had been issued, but that possibility is too speculative to award standing in this matter. It should also be noted that none of the parties hereto objected to Symetria’s involvement in the final hearing, including its introduction of evidence and examination of witnesses. Intervenor, CFSATC, d/b/a Central Florida Substance Abuse (“CFSATC”), is a Florida corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. CFSATC submitted seven applications for licensure under the Emergency Rule. None of its applications were approved by the Department. CFSATC timely filed an administrative challenge to its denied applications. CFSATC has standing to intervene in this proceeding. Intervenor, Bay County Healthcare Services, LLC (“Bay County Healthcare”), is a Georgia limited liability company and is currently licensed to operate a methadone medication- assisted treatment clinic in Florida. Bay County Healthcare submitted eight applications for licensure under the Emergency Rule. None of its applications were approved by the Department. Bay County Healthcare timely filed an administrative challenge to its denied applications. Bay County Healthcare has standing to intervene in this proceeding. Intervenor, Palm Beach Drug Testing, LLC, d/b/a Relax Mental Health Care (“Relax”), submitted 14 applications for licensure under the Emergency Rule; eight of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of Relax. Relax has standing to intervene in this proceeding. Intervenor, Colonial Management Group, L.P. (“Colonial”), operates methadone medication-assisted treatment centers nationwide, including Florida. Colonial submitted 19 applications for licensure under the Emergency Rule; all 19 of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of Colonial. Colonial has standing to intervene in this proceeding. Intervenor, PAS, submitted 48 applications for licensure under the Emergency Rule; twenty of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of PAS. PAS has standing to intervene in this proceeding. Procedural History On May 3, 2017, Governor Scott signed Executive Order No. 17-146, alluding to the nearly 4,000 deaths in Florida caused by opioids during calendar year 2015. Florida had nearly 10 percent of all opioid-related deaths in the entire country that year. The Governor declared that an opioid epidemic threatens the State and has created an emergency situation. He directed the State Health Officer and Surgeon General to announce a statewide public health emergency. The Governor’s executive order noted that the United States Department of Health and Human Services had awarded a grant of $27,150,403 per year for two years to the Department to provide prevention, treatment, and recovery support services to address the opioid epidemic. The Governor said it was necessary to immediately draw down those federal grant funds in order to provide services to Florida communities, and that the State could not wait until the next fiscal year (which would start two months hence, on July 1, 2017) to begin that distribution. On June 29, 2017, the Governor signed Executive Order No. 17-177, extending for an additional 60 days the state of emergency declaration set forth in Executive Order 17-146. This action was precipitated by hurricanes threatening the State. The executive orders issued by the Governor appear to direct State agencies to utilize the federal grant monies to bolster existing providers of treatment. Nothing in the executive orders issued by the Governor directs the approval of additional opioid treatment centers. There is, however, an omnibus provision in the executive order directing the State Health Officer to “take any action necessary to protect the public health.” The Department’s response to the executive orders was to publish emergency rule 65DER17-1 in the FAR on August 25, 2017. That rule was superseded by the Emergency Rule, which revised the dates during which applications for licensure could be submitted. This change was deemed necessary in response to the devastation wrought by Hurricane Irma, making travel to Tallahassee (for delivery of applications) somewhat difficult during the timeframes set forth in emergency rule 65DER17-1. The Notice of Emergency Rule, as published in the Florida Administrative Register, states in full (with strikethrough/underline in original): Notice of Emergency Rule DEPARTMENT OF CHILDREN AND FAMILIESSubstance Abuse Program RULE NO.: RULE TITLE: 65DER17-2 Standards for Medication-Assisted Treatment for Opioid Addiction SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE: On May 3, 2017, the Governor of the State of Florida signed Executive Order Number 17-146 declaring that the opioid epidemic threatens the State with an emergency and that, as a consequence of this danger, a state of emergency exists. Also, in the executive order, the Governor directed the State Health Officer and Surgeon General to declare a statewide public health emergency, pursuant to its authority in section 381.00315, F.S. On June 29, 2017, the Governor signed Executive Order Number 17-177 to extend the state of emergency declaration. The department was recently awarded a two-year grant to address this opioid epidemic. The department will use these funds in part to expand methadone medication-assisted treatment services in needed areas of the state as part of a comprehensive plan to address the opioid crisis. Revising the licensure requirements through an emergency rule is necessary to accommodate the critical need for more methadone medication-assisted treatment providers. Due to the impact of Hurricane Irma on providers and individuals in treatment, the department has determined that extending the submission dates for applicants is necessary. REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: The procedure is fair under the circumstances because it ensures equitable treatment of methadone medication-assisted treatment providers. SUMMARY: This rule makes changes to permanent Rule 65D-30.014 F.A.C., relating to licensure requirements for methadone medication-assisted treatment programs. THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Bill Hardin. He can be reached at William.Hardin@myflfamilies.com or Office of Substance Abuse and Mental Health, 1317 Winewood Boulevard, Building 6, Tallahassee, Florida 32399-0700. THE FULL TEXT OF THE EMERGENCY RULE IS: 65DER17-2 (65D-30.014): Standards for Medication-Assisted Treatment for Opioid Addiction. 65DER17-2 supersedes 65DER17-1. In addition to Rule 65D-30.004, F.A.C., the following standards apply to Standards for Medication-Assisted Treatment for Opioid Addiction. State Authority. The state authority is the department’s Office of Substance Abuse and Mental Health. Federal Authority. The federal authority is the Center for Substance Abuse Treatment. Determination of Need. Criteria. In accordance with s. 397.427, F.S., the department shall not license any new medication-assisted treatment programs for opioid addiction until the department conducts a needs assessment to determine whether additional providers are needed in Florida. The determination of need shall only apply to methadone medication-assisted treatment programs for opioid addiction. Department of Correction facilities are excluded from this process. The department shall use a methodology based on a formula that identifies the number of people who meet the criteria for dependence or abuse of heroin or pain relievers who did not receive any treatment, and the number of opioid-caused deaths. This formula will be weighted, with 70 percent driven by the number of people with an unmet need for treatment and 30 percent driven by the number of deaths. In its effort to determine need, the department shall examine the following data: Population estimates by age and by county; Number of opioid-caused deaths; Estimated number of past-year nonmedical pain reliever users; and Estimated number of life-time heroin users; Procedure. By August 28, 2017, the department will conduct a needs assessment to determine whether additional methadone medication-assisted treatment providers are needed in Florida. The department will publish a determination of need in the Florida Administrative Register and on the department’s website at http://www.myfl families.com/service-programs/substance- abuse on August 30, 2017. If the department determines that additional providers are needed, the department will also publish instructions for submitting an appropriate application. Applicants interested in providing methadone medication-assisted treatment must complete and submit CF-MH 4036 titled, “Methadone Medication-Assisted Treatment Provider Application in Response to Emergency Rule”, June 2017, incorporated herein by reference. Form CF-MH 4036 is available from the department’s website at https://eds.myflfamilies.com/DCFForms Internet/Search/DCFFormSearch.aspx and at http://www.myflfamilies.com/service- programs/substance-abuse. Applications must be complete and responsive to all of the questions on this form. Applications will be accepted at department headquarters from October 2, 2017 September 22, 2017 at 8 a.m. Eastern Time until October 23, 2017 October 13, 2017, at 5 p.m. Eastern Time. Applications must be delivered to the following address: Florida Department of Children and Families, Office of Substance Abuse and Mental Health, 1317 Winewood Boulevard, Building 6, Tallahassee, Florida 32399-0700. For the application review period in response to this emergency rule, the department will use CF-MH 4037 titled, “Review Form for Methadone Medication- Assisted Treatment Provider Application in Response to Emergency Rule”, June 2017, incorporated herein by reference. Form CF- MH 4037 is available from the department’s website at https://eds.myflfamilies.com/ DCFFormsInternet/Search/DCFFormSearch.aspx and at http://www.myflfamilies.com/service- programs/substance-abuse. Should the number of applications for a new provider in a Florida county exceed the determined need, the selection of a provider shall be based on the order in which complete and responsive applications are received by the Office of Substance Abuse and Mental Health headquarters. Applicants who are approved to apply for licensure will receive notices from the department by November 17, 2017 November 10, 2017. Applicants who receive approval notices shall submit applications for licensure to the department’s regional Substance Abuse and Mental Health office(s) where the service will be provided. The regional Substance Abuse and Mental Health office will process applications for licensure in accordance with the standards and requirements in 65D-30, F.A.C. through (6) No change. Rulemaking Authority 397.321(5) F.S. Law Implemented 397.311(25)(a)7., 397.321(1), 397.419, FS. History–New 5-25-00, Amended 4-3-03, Amended 8-25-17, Amended 9-19-17. THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE. EFFECTIVE DATE: 9/19/2017 Petitioners filed challenges to the Emergency Rule at DOAH on December 11, 2017, 83 days after the effective date set forth in the FAR. Respondent asserts that the Emergency Rule is merely an amendment to Rule 65DER 17-1, which had an effective date of August 25, 2017. Thus, reasons Respondent, challenges to the Emergency Rule were due on or before November 23, 2017, i.e., 90 days after August 25, 2017. However, emergency rules are not renewable so as to expand their validity beyond 90 days. § 120.54(4), Fla. Stat. As set forth above, the clear language appearing in the FAR establishes September 19, 2017, as the effective date of the Emergency Rule. Had the Department wished to retain the effective date from the prior rule, it certainly could have done so. It did not. Petitioners’ challenge to the Emergency Rule was timely. Background Florida has had rules in effect for 18 years regarding the need for opioid treatment centers around the State. Florida Administrative Code Rule 65D-30.014 is entitled, “Standards for Medication and Methadone Maintenance Treatment.” This rule sets forth the process for providers to request licenses to establish new opioid treatment facilities, based on the Department’s annual determination of need. According to the rule, the Department is to conduct an annual assessment of need, publishing the results of that assessment by June 30 of each year, although, inexplicably, no assessment was done for calendar years 2016 or 2017. After the need assessment is published, the Department directs interested parties to submit applications for licensure to the Department’s district office in the area where the need exists. All such applications would have to be submitted no later than on a “closing date” to be provided by the Department. The Department’s district office would receive the application(s) and conduct a formal rating of the applicant(s). There were minimum requirements each applicant must meet in order to be considered for licensure. If the number of applicants exceeded the determined need, the selection of a provider would be done based on certain substantive criteria, e.g., number of years the applicant has been licensed; the organizational capability of the applicant; and the applicant’s history of noncompliance with Department rules. Pursuant to rule 65D-30.014, the Department had conducted assessments in calendar years 2012, 2013, 2014, and 2015. The award of licenses based on the 2012 and 2013 need assessment was delayed by litigation. A need for 31 additional treatment centers was found in 2014, but no applications were accepted by the Department due to the ongoing litigation relating to the previous years. The following year, 2015, the Department found a need for only five additional treatment centers, even though none of the 31 treatment centers identified as needed in 2014 had been awarded to anyone. The 2015 assessment was lower than the prior year due to some changes in the methodology used by the Department. The Department did not accept any applications to meet the established need in 2015. One rationale for not accepting applications, even though there was a need, was that the Department was drafting new rules. That process would give stakeholders an opportunity for input. The notices that the rules were being developed, however, were not filed until some 11 months after the 2015 need projections were published. The Department explained that it was busy with other rulemaking duties during that time, causing some delay. Developing the Emergency Rule After entry of the Governor’s executive orders, the Department began the process of distributing the federal grant money to existing treatment centers. The Department, though it never met with the Governor to discuss use of the grant funds, handed out the funds to various existing clinics in order to help them deal with the clinics’ backlogs and waiting lists. There was no discussion between the Governor and the Department concerning the necessity for new clinics. A needs assessment was apparently conducted by the Department. The Department based its assessment in part on data it had gathered when applying for the federal grant. Existing treatment centers had provided the Department waiting lists, indicative of a greater need than could be met by the existing clinics. That data, however, was only from public providers; private providers were not included. The public providers were essentially those contracting with the Department’s “managing entities,” who act as intermediaries between the provider and the Department. An emergency rule was proposed as the vehicle for addressing the need and acquiring applications for licensure. Though the Department’s Director of Substance Abuse and Mental Health thought it best to simply proceed with the rule currently under development, the Emergency Rule was pursued. The thinking at the Department was that the existing rule had created considerable litigation that the Emergency Rule might avoid. That did not happen. The emergent situation warranting an emergency rule was, according to the Department, the scenario described by the Governor in his executive orders. The Department of Health had declared a public health emergency, which was also used as a basis for creating the Emergency Rule. The federal grant funds, however, were not an impetus for creating the Emergency Rule. The Emergency Rule relied upon data from calendar year 2015, as it was the latest data available to the Department at that time. The Governor’s executive orders had also relied upon 2015 data. Some interim data had been available, but the only full year of information available at the time the rule was promulgated was for 2015. The interim data, however, indicated a sharp (approximately 30 percent) increase in need. The Department published a determination of need on its website on August 30, 2017. Apparently the need determination was not published in the FAR despite the directive to do so in subsection (3)(b) of the Emergency Rule. The Department found a need for one clinic each in 47 of Florida’s 67 counties, as well as for two in Hillsborough County, for a total of 49 new clinics. Pursuant to the Emergency Rule, interested applicants were to file an application on the Department’s approved form (CF-MH 4036, attached hereto as an Addendum) expressing an interest in becoming licensed in one or more of those counties. Such applications were to be “accepted at department headquarters from October 2, 2017, at 8 a.m., Eastern Time, until October 27, 2017 at 5 p.m., Eastern Time. Applications must be delivered to [the department].” In contrast to rule 65D- 30.014, applications under the Emergency Rule were to be filed at the Department’s headquarters in Tallahassee rather than in the various district offices around the State. The application form utilized by the Department is a one-page document. The form requests minimal identification information concerning the applicant and its business (questions 1 through 10). Question 11 asks if the applicant plans to accept Medicaid-eligible, indigent, and/or pregnant women as patients. The 12th question directs the applicant to submit documentation concerning its target population, proof of a physician on staff, the anticipated date of initiation of services, and proof of registration with the Department of Revenue or Division of Corporations. The Department also created a “review form,” used to check the completeness of applications. The review form mirrors the application, providing a space for the Department reviewer to state whether the applicant had completed each section of the application form. The Department maintains that the applicants’ responses to Question 11 were not considered in its review of the applications submitted under the Emergency Rule. This was because, according to the Department, a response to that question might favor one applicant over another. The Department did not elaborate as to how this “favoritism” might negatively affect the process. The question had been used under the prior rules and had been deemed important, presumably because--as reported by some of the parties herein--a large majority of their patients were either Medicaid-eligible, indigent persons, or pregnant women. It certainly was reasonable that the Department would ensure that those groups of citizens, who were undoubtedly accounted for in the need assessment, had access to approved treatment centers under the Emergency Rule. Nonetheless, the Department did not utilize the Question 11 responses in its review. This is contrary to the plain language of the Emergency Rule, which states: “Applications must be complete and responsive to all questions on this form.” (emphasis added). See 65DER17- 2(3)(b)1. The Emergency Rule as published contained the following language: “REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: The procedure is fair under the circumstances because it ensures equitable treatment of methadone medication-assisted treatment providers.” Neither the Emergency Rule language nor the Department at final hearing provided a persuasive rationale for that statement and conclusion. In fact, the Department acknowledged that if the first person in line had filed applications for all 49 new clinics, all the other applicants would have been denied the right to seek licensure. How is that fair? What the Emergency Rule did was to set a window within which interested applicants could either mail, overnight-deliver, or hand-deliver a copy of the one-page application and attachments to the Department’s headquarters in Tallahassee. The Department felt that allowing applications to be submitted via email would potentially crash its email system, so email submission was not allowed. The applications received first by the Department were to be approved, notwithstanding any substantive shortcomings or comparative failings of those applications as compared to applications received later. No other criteria were considered; first was deemed best. What is fair about approving competing applications based on who filed first rather than on substantive differences in the services being proposed? What actually transpired vis-à-vis submission of the applications was not foreseen by the Department or by most of the applicants. That is, some applicants either lined up at Department headquarters days prior to the 8:00 a.m. acceptance time on October 2, 2017, or had someone wait in line for them. Then, when the doors opened at 8:00 a.m., the first person in line presented applications for 19 of the 49 sites identified by the Department as having a need. The second applicant in line submitted 17 applications, etc. By the time each of the Petitioners reached the front of the line, only minutes after the doors had opened, applications for their prospective counties of interest had already been filed. Under the Emergency Rule, the earlier filed applications were accepted without comparison to competing applications. As a result, Colonial was approved for 19 licenses; PAS was approved for 20; and Relax obtained eight; i.e., 47 of the 49 licenses were obtained by just three individual applicants. Again, the Department acknowledged that “[a]fter it, you know, happened the way it did, there were many considerations that we should have made.” Ute Gazioch, Jt. Exh. 6, page 81. Interestingly, the first application accepted by the Department was by an applicant who did not even appear at Department headquarters. That applicant, Lakeview Center, Inc., submitted its application via FedEx. The FedEx box containing Lakeview Center’s application was received and clocked in by an office at Department headquarters, other than the Substance Abuse and Mental Health office, at 7:40 a.m., i.e., prior to the window for filing. When the application made its way to the appropriate office, it was deemed received at 8:00 a.m. As a result, it was “first in line.” The incongruity of that situation was not persuasively justified by the Department. In fact, the Department testified that if all of the applications had been filed at the wrong office, it would likely have simply defaulted to an 8:00 a.m. arrival time for each one. Upon being approved, an applicant would then be allowed to submit an application for licensure. Under the licensure process, the applicant would be vetted in order to assure it met at least minimal requirements for obtaining a license. No comparison of the approved applicant to other applicants was made by the Department to ascertain whether another applicant might be superior as to services provided. Rather, if the approved applicant could satisfy, even minimally, the licensure requirements, it would be granted the right to seek a license. Once licensed, it could take considerable time and financial resources to effectuate the opening of a new opioid treatment clinic. There are many factors to be addressed and resolved, including but not limited to: acquisition of an appropriate site, whether by way of purchase of undeveloped property and new construction or lease/purchase of an existing building; construction or renovation, as needed; zoning concerns; permitting by state, county, and/or municipal bodies; staffing; coordination of state and federal licenses or certifications; etc. It is not uncommon for the process to take up to two years, sometimes more. In addition, the financial expenditures could be in the hundreds of thousands of dollars (and even as much as a million dollars) for each project. For this reason, the Department did not foresee that any entity might apply for so many applications as actually transpired. The likelihood that a single entity would have the time, money, or other resources to move forward on multiple products at one time is small. It is more likely that a single entity receiving approval for multiple new clinics might “bank” the approvals, expending time and money for only a few at a time, at best. If so, that could result in far fewer new clinics coming on line than the 49 projected by the Department under the Emergency Rule. As the applications contained no requirement to provide financial information, it is impossible for the Department to determine whether the approved entities, which received multiple approvals, could successfully–-and timely–-complete their projects. There is no specific time frame for which a granted applicant must commence operations once approved. However, as the approvals were done pursuant to an “emergency,” it follows that clinics should be opened as soon as practicable. Petitioners assert that the “first in line” scheme enunciated in the Emergency Rule is arbitrary, capricious, and patently contrary to a determination of the applicants’ ability to provide care to persons suffering opioid addiction. The facts bear that assertion out.

Florida Laws (14) 120.52120.54120.56120.569120.57120.595120.60120.68381.00315397.301397.305397.321397.419397.427
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs NORMA S. LAKE, M.D., 17-006179PL (2017)
Division of Administrative Hearings, Florida Filed:Miami, Florida Nov. 09, 2017 Number: 17-006179PL Latest Update: Dec. 25, 2024
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BOARD OF MEDICAL EXAMINERS vs. MARIA APIAU, 83-001206 (1983)
Division of Administrative Hearings, Florida Number: 83-001206 Latest Update: Aug. 29, 1990

The Issue Whether respondent, a licensed physician, violated provisions of Chapter 458, Florida Statutes, by allegedly (1) failing to keep medical records justifying her course of treatment; (2) prescribing controlled substances (Methaqualone) other than in the scope of her professional practice; (3) prescribing a Scheduled II controlled substance (Methaqualone) for a purpose not allowed by statutes; (4) engaging in gross or repeated malpractice or failing to practice medicine in accordance with medical standards recognized as acceptable by reasonably prudent similar physicians under similar conditions; (5) failing to perform a statutory obligation; (6) making untrue or fraudulent representations or employing a trick or scheme in the practice of medicine, and exploiting patients for financial gain.

Findings Of Fact Respondent, 54, is a female medical doctor licensed to practice medicine in the State of Florida. From August through December 1981, she was the sole physician employed by Northeast Medical Services, Inc. ("the clinic"), a clinic located at 4600 North Federal Highway, Ft. Lauderdale, Florida. The clinic also employed a nurse, a psychologist, and a receptionist. Clinic patients were processed under a standardized office procedure. First, they would fill out personal information and medical history forms, then answer a written "Stress Questioanaire," and sign a "drug potency warning." Next, they would be screened by a psychologist and physically examined by a nurse and respondent. Most patients came to the clinic complaining of stress or stress related symptoms. 1/ Most patients were diagnosed as suffering from stress. The treatment usually consisted of prescribing stress (vitamin) tablets and 45 tablets of 300 mg. Methaqualone, for which patients paid $75 to $100 in cash. During the several months she was employed by the clinic, respondent saw 15 to 20 patients a day, sometimes many more. From August 13, 1981, through October 30, 1981, she wrote at least 378 separate prescriptions for Methaualone (45 tablets, 300 mg.) totaling 17,010 tablets. (Petitioner's Exhibit No. 2) II. Barbara Bennett: Counts 1-24 On September 9, 1981, Barbara Ann Bennett visited respondent at the clinic. She completed the personal information and medical history forms, was screened by the psychologist, and physically examined by respondent. The physical examination included taking her weight, height, pulse, respiration, and blood pressure. Respondent checked her general appearance, skin, head, eyes, ears, nose, throat, heart, lymph nodes and neurological responses. Respondent spoke with her and noted in her progress report that the patient did not like her job as a bartender and did not sleep well. The Stress Questionnaire completed by Ms. Bennett indicated that she came to the clinic for the sole purpose of reducing stress. She checked-off items reflected that, among other symptoms, she had experienced poor sleep, was under a great deal of stress, and was unable to relax. Respondent rendered an initial impression or diagnosis of stress and prescribed stress (vitamin) tablets, 600, No. 30, 30 tablets and Methaqualone, 300 mg., 45 tablets, with directions to take one tablet at bedtime and one-quarter tablet twice a day, as needed. At that time, Chapter 893, Florida Statutes, identified Methaqualone as a Schedule II controlled substance, a substance with a high potential for abuse but which had an accepted but severely restricted medical use and treatment in the United States. This statute recognized that it could be abused and result in severe psychological and physical dependency. In 1981, Methaqualone--a non-barbiturate--was known as a highly potent hypnotic drug which was subject to widespread and growing abuse. It was gaining a reputation as a street drug, and was referred to as quaaludes. For patients diagnosed as suffering from stress, prevailing medical standards (in the area where respondent practiced) dictated the prescription of a mild tranquilizer for daytime use, not a potent hypnotic such as Methaqualone. Generalized complaints of stress, including checked-off items such as contained on the Stress Questionnaire used by respondent, were insufficient to justify prescribing a powerful drug such as Methaqualone, for either night or daytime use. As Dr. Warren Zundell, a qualified physician, testified at hearing: If 100 people were taken off the street and asked if they had stress--100 would say "yes." Prescribing Methaqualone for such patients was, in Dr. Zundell's opinion "like hunting ants with an elephant gun." (TR.-250) For sleeping problems, a milder hypnotic--of which there were several--was the appropriate treatment. Although respondent's initial diagnosis of stress was justified, her prescription of Methaqualone for night and daytime use (though with a lesser dosage) was inappropriate, medically unjustified, and constituted a failure to practice medicine with that level of care which is recognized by reasonably prudent similar physicians as acceptable under similar conditions. Under prevailing medical standards of practice then in effect, the diagnosis of stress did not justify more than the prescription of a mild tranquilizer or sedative. Ms. Bennett's alluded to sleeping problem did not justify the prescribing of Methaqualone when there were many other hypnotics available which were less potent and less subject to abuse. The medical records kept by respondent did not justify her prescribing Methaqualone to Ms. Bennett. The Methaqualone was thus prescribed other than in the course of respondent's professional practice and for other than a legitimate medical purpose. On September 11, 1981, Ms. Bennett was hospitalized at Hollywood Memorial Hospital for a drug overdose. The hospital staff contacted respondent who confirmed that she had issued the September 9, 1981 prescription for Methaqualone. Notation of this call was made in Ms. Bennett's patient records. On or about November 17, 1981, respondent issued Ms. Bennett another prescription for stress tablets and Methaqualone, identical in amount to the September 9, 1981, prescription. Presumably, this prescription was for the purpose of treating the same symptom--stress. It was not medically justified, inappropriate, and outside the scope of her professional practice. The patient's medical records did not justify this prescription. In fact, there are no records of Ms. Bennett's having visited the clinic on November 17, 1981. The prescribing of Methaqualone to Ms. Bennett, especially in light of her prior hospitalization for a drug overdose, constituted a gross failure to practice medicine with that level of care recognized by reasonably prudent similar physicians as accepted under similar conditions. Adrienne Gampel: Counts 25-48 On August 28, 1981, Ms. Adrienne Gampel visited respondent at the clinic. Personal and medical history were taken and the Stress Questionnaire was completed. She acknowledged that she came to the clinic for the sole purpose of reducing stress, and checked off descriptors on the questionnaire indicating that she was under a great deal of pressure at home and had experienced poor sleep. After seeing the psychologist she was given a complete physical examination, similar to that given Ms. Bennett. Respondent rendered a diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets. For the reasons stated in paragraphs 6 and 7 above, the prescription of Methaqualone to Ms. Gampel was inappropriate, not medically justified, and not justified by respondent's medical records. It was outside the scope of her professional practice and constituted a failure to practice medicine with that level of care recognized by reasonably prudent similar physicians as acceptable under similar conditions. In October and November 1981, Ms. Gample revisited respondent at the clinic. It has not been shown, however, that a new Methaqualone prescription was issued on either occasion. Robert Distillator: Counts 49-81 On September 3, 1981, Robert Distillator visited the respondent at the clinic. His personal and medical history were taken, and the Stress Questionnaire was completed. He acknowledged that he came for the sole purpose of reducing stress and checked-off descriptors on the questionnaire indicating that he had experienced loss of appetite, poor sleep, boredom on weekends, difficulty in making decisions, inability to have a good time, and a great deal of pressure. He also indicated he felt tense, depressed, unable to relax, and had more problems than he could handle. A complete physical examination was given him and his blood was analyzed. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg. 45 tablets, with directions identical to those given Ms. Bennett. For the reasons provided in paragraphs 6 and 7 above, respondent's prescribing of Methaqualone for night and daytime use was medically unjustified, inappropriate, not justified by the records, and outside the scope of her professional practice. It constituted a failure to practice medicine with that level of care recognized by reasonably prudent similar physicians as acceptable under similar circumstances. Furthermore, it was inappropriate to prescribe Methaqualone to a patient, such as Mr. Distillator, who indicated depression, since such a symptom would increase the likelihood of self-abuse. On or about October 7, 1981, Mr. Distillator revisited respondent at the clinic. However, it has not been shown that he was issued another Methaqualone prescription on that occasion. On or about November 5, 1981, he revisited respondent at the clinic. His blood was analyzed and he was then issued another prescription for stress tablets and Methaqualone--identical in all respects to his first prescription. This prescription was not even noted by respondent in the patient's medical records. For the reasons stated in paragraphs 6 and 7 above, her prescription of Methaqualone was inappropriate, not medically justified, outside the scope of her professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions. On December 14, 1981, respondent issued Mr. Distillator another prescription of stress tablets and Methaqualone, in like amount. The prescription was not noted in his patient records. Presumably, it was given for the continued treatment of stress. For the reasons specified in paragraphs 6 and 7 above, this prescription was inappropriate, medically unjustified, not justified--or even noted--in the patient's medical records, and was outside the scope of professional practice. It constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions. Joe Morreale: Counts 81-96 On October 12, 1981, Joe Morreale visited respondent at the clinic. His personal and medical history were taken, the Stress Questionnaire was completed, and a physical was given. He acknowledged on the questionnaire that his sole purpose for coming was to reduce stress, and checked-off descriptors indicating that he had experienced pressure at home and at work, headaches, nightmares, and poor sleep. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone 300 mg., 45 tablets, with her standard instructions--one daily at bedtime and one-quarter tablet, twice a day, as needed. For the reasons specified in paragraphs 6 and 7 above, the prescribing of Methaqualone to Mr. Morreale was inappropriate, medically unjustified, not justified by the records, outside the scope of professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar circumstances. On December 11, 1981, Mr. Morreale revisited respondent at the clinic. However, it has not been shown that she issued him another prescription for Methaqualone at that time. Joani Levi: Counts 97-104 On September 30, 1981, Ms. Joani Levi visited respondent at the clinic. A personal medical history was taken, the questionnaire was completed, and a physical was given. On the questionnaire, she indicated that the sole purpose of her visit was to reduce stress, and checked-off descriptors indicating she had experienced poor sleep, marital problems, and pressure at work. Respondent noted in her records that the patient was confused, nervous, and suffering extreme anxiety. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets, with her standard instructions for night and daytime use. For the reasons provided in paragraphs 6 and 7 above, this prescription was inappropriate, not medically justified, not justified by the patient's medical records, and outside the scope of professional practice. It constituted a failure to practice medicine with that level of care which is recognized by reasonably similar prudent physicians as acceptable under similar conditions. Rachel Mack: Counts 105-112 On September 28, 1981, Ms. Rachel Mack visited Respondent at the clinic. Her medical history was taken and the Stress Questionnaire was completed; then she was given a physical. On the questionnaire, she indicated her sole reason for coming was to reduce stress. She checked-off descriptors indicating that she had experienced poor sleep, difficulty in making decisions, disturbing thoughts or fears, pressure at work and at home, and inability to have a good time. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets, with her usual instructions. For the reasons stated in paragraphs 6 and 7 above, the prescribing of Methaqualone to Ms. Mack was inappropriate, medically unjustified, not justified by her patient records, and beyond the scope of professional practice. It constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions. Robin Millman: Counts 113-128 On September 14 and 23, 1981, respondent issued Ms. Robin Millman, an employee at the clinic, a prescription for Methaqualone, 300 mg., 45 tablets. The purpose of this prescription was to relieve stress. There are no medical records justifying this treatment. Indeed, there were no patient records for Ms. Millman. For the reasons stated in paragraphs 6 and 7 above, this prescription was medically unjustified, inappropriate, outside the scope of professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar circumstances. Brenda Villa: Counts 127-161 On September 5, 9, 14, October 22, and November 12, 1981, respondent issued Ms. Brenda Villa, another employee of the clinic, a prescription for Methaqualone, 300 mg., 45 tablets, for the purpose of treating stress. There were no patient records for Miss Villa, and there were no medical records justifying this prescription. For the reasons stated in paragraphs 6 and 7 above, the prescription was inappropriate, medically unjustified, outside the scope of professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably similar prudent physicians under similar conditions. Michael Bransfield: Counts 162-169 On September 24, 1981, Michael Bransfield visited respondent at the clinic. A personal and medical history was taken, the Stress Questionnaire was completed, and a physical was given. On the questionnaire, he indicated that the sole purpose of his visit was to reduce stress. He checked off descriptors indicating he had experienced poor sleep, pressure at home and at work, and inability to relax. Respondent rendered a diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets, with her usual instructions for night and daytime use. For the reasons provided in paragraphs 6 and 7 above, this prescription was inappropriate, not medically justified, not justified by the patient's medical records, and outside the scope of professional practice. It also constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions.

Recommendation Based on the foregoing, it is RECOMMENDED: That respondent's license to practice medicine be revoked for multiple violations of the Medical Practice Act. DONE and ENTERED this 5th day of April 1984, in Tallahassee, Florida. R. L. CALEEN, JR. 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 5th day of April 1984.

Florida Laws (2) 120.57458.331
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DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES vs. JACKSONVILLE METHODIST HOME, INC., 83-003414 (1983)
Division of Administrative Hearings, Florida Number: 83-003414 Latest Update: Dec. 10, 1984

The Issue The issues concern the question of whether the discovery of certain deficiencies related to the placement of legend drugs at the bedside of residents within the respondent's facility should be classified as a Class II or Class III deficiency within the meaning of Section 400.23, Florida Statutes.

Findings Of Fact On September 19 through 21, 1983, the State of Florida, Department of Health and Rehabilitative Services made an inspection of the Skilled Nursing Facility, operated by Jacksonville Methodist Home, Inc. as part of the Wesley Manor Retirement Village. That inspection was in keeping with the provisions of Chapter 400, Florida Statutes. The location of the facility is in St. Johns County, Florida. In the course of this inspection, in the room of one of the patients, the legend drugs Nitrol Ointment 2 percent and Aristocort A 0.1 percent Creme were discovered at the bedside of that patient. In another room, related to a second patient, the legend drug Timoptic 0.5 percent Eye Drops was found. Finally, in a third room, the legend drug Granulex Spray was found at the bedside of that patient. Although the patients were relatively alert and there was more than the minimum staffing required of such facilities, certain other ambulatory residents within the facility could have gained admittance into the three rooms where patients were residing for whom the various legend drugs had been prescribed. No indication was given that patients other than those for whom the legend drugs had been prescribed had used these legend drugs or of any other such event in the past history of the facility. While the facility in question had not experienced problems with the patients misusing legend drugs, there have been occasions in the experience of the inspector for the State, Patricia Dill, who is a graduate nurse, in which residents in comparable facilities have entered rooms of other patients and taken drugs not prescribed for that intruder. As indicated in the petitioner's Exhibit No. 2 admitted into evidence, there were 55 patients in the facility on September 19, 1983, of which 37 were listed as confused or disoriented, and 19 patients were under a form of restraint. Twelve patients required no assistance with ambulation and 32 required some form of assistance such as wheelchair, cane, or otherwise. Nitrol Ointment is a timed release nitroglycerin, to be used three times a day, which has the effect of release over an eight hour period and is prescribed for persons suffering angina. If used by a patient for whom it was not prescribed it might cause headaches or vomiting, if ingested. Placing the ointment on the skin would cause a lowering of blood pressure in patients for whom it was not prescribed. Aristocort Creme is a steroid, not for ingestion. If ingested it could cause the patient to feel bad, to include possible vomiting. Placement in the eyes would cause a problem with sight. Timoptic Eye Drops are related to the treatment of glaucoma and would not normally cause problems if swallowed, as opposed to being placed in the eyes. Granulex Spray is an enzyme which attacks dead tissue. Properties that present any danger to the patient would be related to spraying into the eyes. It is the aerosol feature of the Granulex Spray which presents that problem. The misuse of the legend drugs in question would not be expected to be a life-threatening event. Based upon the observations of legend drugs within the patient rooms, respondent is said to have violated the provisions of Rule 10D-25.112 (11), Florida Administrative Code. While the respondent concedes such violation, it disagrees with the petitioner's characterization of this violation as a Class II violation, and requested the formal hearing to challenge that classification.

Recommendation Upon a full consideration of the facts found and the conclusions of law reached, it is RECOMMENDED: That a final order be entered which classifies the violations related to the discovery of legend drugs in the rooms of the residents/patients as Class III deficiencies. DONE and ENTERED this 31st day of August, 1984 in Tallahassee, Florida. CHARLES C. ADAMS Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of August, 1984. COPIES FURNISHED: Jonathan S. Grout, Esquire Department of Health and Rehabilitative Services Post Office Box 210 Jacksonville, Florida 32231 R. Grady Snowden, Jr. Administrator Wesley Manor Retirement Village State Road 13 and Julington Creek Road Jacksonville, Florida 32223 David Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301

Florida Laws (2) 120.57400.23
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs GARY J. COWEN, M.D., 11-005703PL (2011)
Division of Administrative Hearings, Florida Filed:Miami, Florida Nov. 03, 2011 Number: 11-005703PL Latest Update: Dec. 25, 2024
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs NORMA S. LAKE, M.D., 17-001974PL (2017)
Division of Administrative Hearings, Florida Filed:Miami, Florida Mar. 30, 2017 Number: 17-001974PL Latest Update: Dec. 25, 2024
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