The Issue In addition to the issue of whether the Respondent committed the acts alleged, the administrative complaint alleges on its face that the Respondent was not licensed to practice medicine in the State of Florida until July 13, 1982. Most of the administrative complaint relates to alleged violations by the Respondent prior to the date of his licensure. A primary issue is the Petitioner's jurisdiction over the Respondent to prosecute for acts committed prior to his licensure. A major factual issue in this case are the dates upon which the doctor's conduct allegedly took place.
Findings Of Fact The Respondent was licensed as a medical doctor on July 13, 1982, in the State of Florida. Prior to that date the Respondent was not licensed to practice medicine in this or any other state. Prior to his licensure he was participating in a medical internship program in Pensacola, Florida. He was permitted to practice and prescribe medicine as an intern in and within the limits of this program. (Re: Count I through Count IV) The Respondent presented prescriptions for Eskatrol and Dexedrine on two different occasions to two different pharmacies. These prescriptions listed the Respondent as the person for whom the prescriptions were filled and signed by the Respondent. Neither prescription was accepted by the pharmacists and neither prescription was introduced into evidence. Eskatrol and Dexedrine are amphetamine compounds and are Schedule II controlled substances. The Respondent's ex-wife placed the Respondent's use of amphetamines in February of 1981. See Transcript page 95 line 19 through page 96 line 1. One of the pharmacists to whom the prescription was presented by the Respondent was Ann Cole Wilson, the Respondent's former sister-in-law and sister of his ex-wife. Wilson's testimony concerning the date of the alleged occurrence testifies as follows: Q. Can you tell me what occurred on that occasion, and tell me approximately when this occurred? A. Like I say, it's hard to remember. It was sometime during the summer months. Q. The summer of what year? A. Oh, gosh. Right now it's been, let's see, `82 or `83. Q. The summer of `82? A. I would say `82 yeah. The other pharmacist who testified regarding the Respondent's presentation of prescriptions for amphetamines was Elizabeth S. Grimsley. Grimsley testified regarding the alleged events as follows: Q. How did you come to meet him? A. He brought in a prescription one night for, two prescriptions, rather, written for him by himself for Eskatrol and Dexedrine, amphetamine prescriptions. Q. These prescriptions were written for the use of Dr. Taylor and they were written by Dr. Taylor? A. Yes, sir. Q. Do you remember approximately when this occurred? A. No, sir; roughly a year and a half or two years ago, I suppose. The latter witness is very vague about the date, and the former witness has an interest in these proceedings by virtue of her relationship with the Respondent's former wife. The relationship by Respondent and his former wife is characterized by hostility and continuing litigation arising out of their divorce and concerning child custody. It is concluded that the Petitioner failed to prove the acts occurred after the date of the Respondent's licensure. (Counts V, VI) The Respondent ordered legend and other drugs from pharmaceutical companies using the name of Michael Archer, M.D. and Archer's DEA registration number. Archer did not approve the order or give the Respondent permission to use his DEA registration in order to obtain these drugs. Respondent's actions took place in 1981 and 1982 prior to the date of the Respondent's licensure by the Florida Board. See the depositions of Farrell, Schied & Perez. (Count VII) Between the dates of March 3, 1982, and June 30, 1982, the Respondent submitted drug orders for and received thirty Crescormon No. 4 iu- vials from Pharmacia Corporated, 800 Centennial Avenue, Piscataway, New Jersey 08854. These events occurred prior to the Respondent's licensure by the Petitioner. See deposition of Schied, Exhibit 3. Respondent ordered amino acids from Varitex Corporation, a Michigan company. These materials which are not legend drugs were ordered and received by the Respondent prior to the date of his licensure by the Petitioner. See deposition of Myers, Exhibit 4. Respondent ordered various drugs from Generix Drug Corp., 1900 W. Commercial Blvd., Ft. Lauderdale, Florida, in the same manner. All these transactions occurred before the Respondent was licensed. See the deposition of Perez, Exhibit 5. (Count VIII) The Respondent sold or provided Darrell R. Black substances represented by the Respondent and thought to be by Black a drug with the trade name Dianabol. Dianabol is a steroid and a legend drug. This transaction was not a part of Dr. Taylor's practice under the Pensacola Education Program, the internship in which Dr. Taylor was participating. This transaction occurred in 1981, prior to Dr. Taylor's licensure by the Board. See Transcript page 38. The Respondent sold or provided to Shaun Francis Farrell drugs represented by the Respondent and thought to be by Farrell testosterone and Deca-Durabolin. This transaction was not part of the Respondent's internship in the Pensacola Educational Program. These transactions occurred in 1981, prior to Respondent's licensure by the Board. See Transcript page 46. (Count IX) The Respondent presented prescriptions for and received various metabolic steroids during 1981. However, all of these were presented prior to the date of the Respondent's licensure by the Board. See Transcript, pages 15, 16, 20, 21, 22, 31, 32, 33. One prescription for Trisorlan was presented by the Respondent for himself on October 20, 1982. Trisorlan is a legend drug, however it is not a controlled substance. Trisorlan is a drug affecting the pigmentation of skin. Transcript page 24. No evidence was received concerning the propriety of Dr. Taylor prescribing this medication for himself. (Count XI) No evidence was received that the Respondent held himself out as being licensed to practice medicine. Black and Ferrell did not see Respondent as a doctor. Respondent saw Cayton at the hospital and was authorized to treat patients within the scope of his internship. Most of the witnesses stated that they knew that the Respondent was a doctor, that he was "practicing" at Sacred Heart Hospital. The Respondent holds a degree as an M.D. and was practicing at Sacred Heart as an intern. Further to the extent that the Respondent may have held himself out as a physician contrary to Section 458.327, he did so prior to the date of his licensure and acquisition of jurisdiction by the Board.
Recommendation Having found no evidence to support the jurisdiction of the Board over the Respondent on the allegations of Count X, the Hearing Officer recommends that the Board take no action against the Respondent and the administrative complaint against the Respondent be dismissed. DONE and ORDERED this 4th day of February, 1985, in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 4th day of February, 1985. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Dorothy Faircloth, Executive Department of Professional Director Regulation Department of Professional 130 North Monroe Street Regulation Tallahassee, Florida 32301 Board of Medical Examiners 130 North Monroe Street William Taylor, M.D. Tallahassee, Florida 32301 5271 Myrtlewood Sarasota, Florida 33580 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Salvatore Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether the Respondent committed the violations alleged in the Amended Administrative Complaint dated March 26, 2010, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing, the facts stipulated to by the parties in the Joint Prehearing Stipulation, and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 456.072, Fla. Stat. The Board of Medicine ("Board") is the entity responsible for regulating the practice of medicine and for imposing penalties on physicians found to have violated the provisions of section 458.331(1). See § 458.331(2), Fla. Stat. At the times pertinent to this proceeding, Dr. Christensen was a physician licensed to practice in Florida, having been issued license number 92135, and he practiced with the A1A Health & Wellness Clinic ("Clinic"), specializing in pain management. In 1975, Dr. Christensen received a degree in chiropractic, and he specialized in chiropractic orthopedics. Dr. Christensen has been practicing chiropractic orthopedics in the Palm Beach, Florida, area since 1975, although he took time away from his practice to attend medical school and to obtain a master's degree in public health. Dr. Christensen received his medical degree in 1995, and he completed a one-year internship in internal medicine. Dr. Christensen was certified in preventive medicine by the American Board of Preventive Medicine on January 22, 2007, and, after passing an examination, he was credentialed in March 2007 by the American Academy of Pain Management. Between February 9, 1997, and February 1998, Dr. Christensen was certified as an addiction professional by the American Association of Acupuncture and Oriental Medicine and the American College of Addictionology and Compulsive Disorders after having taken a 120-hour program in addictionology. Dr. Christensen first saw A.L. at the Clinic on February 12, 2007. At the time, A.L. was 21 years old, having been born on September 17, 1985. At the February 12, 2007, office visit, A.L. completed a Personal History form in which he stated that he was self- employed and worked in construction; that his major complaint was knee and back pain; and that the condition of which he complained began when he was 13 years old, which would have been in or about 1998. A.L. also noted on the Personal History form that he had seen other doctors for "pain management," but he did not include the names of any of the doctors who had provided pain management treatment. Dr. Christensen completed the New Patient History Form at A.L.'s first office visit. He noted that A.L. complained of intense, sharp, incapacitating pain in his left knee, with associated pain in his lower back. A.L. reported that he had had multiple surgeries on his knee that had been unsuccessful. Dr. Christensen performed a general examination of A.L. to confirm that he was alert and oriented and that his organ systems functioned properly. Dr. Christensen noted that A.L. was thin, but he did not identify any abnormal finding. Dr. Christensen did note that A.L. complained of anxiety. Because of A.L.'s complaints, however, Dr. Christensen focused his examination on A.L.'s left knee and lower back. Dr. Christensen observed scars on A.L.'s left knee, which confirmed the multiple surgeries that A.L. reported, and he also noted muscle atrophy of A.L.'s left leg, a condition that Dr. Christensen attributed to lack of exercise of the left leg. Dr. Christensen performed several orthopedic tests targeted at A.L.'s left knee and lower back, and Dr. Christensen's objective physical examination confirmed A.L.'s subjective complaints of pain. The differential diagnosis noted by Dr. Christensen on the New Patient History Form was multiple failed knee surgeries with associated lower back pain and lumbar disc syndrome. Dr. Christensen concluded that A.L. most likely had a lumbar disc problem because of A.L.'s abnormal gait resulting from the knee injury and the resulting pressure on A.L.'s pelvis. Dr. Christensen also noted on the New Patient History Form that A.L. reported that, each month for years, he had taken 60 to 90 80-milligram tablets of Oxycontin; 400 to 600 30- milligram tablets of Roxicodone; 200+ 40-milligram tablets of Methadone; 60 to 90 2-milligram tablets of Xanax; and 3 bottles of Oxifast. Based on these medications, dosages, and quantities, Dr. Christensen considered A.L. overmedicated, and he intended, during his treatment of A.L., to gradually reduce the amount of medications prescribed for A.L. Oxycontin and Methadone are pain medications, and Oxycontin and Roxicodone are trade names for the generic drug Oxycodone. Oxifast is a liquid form of Oxycodone, and Xanax is a drug used to treat anxiety. Both Oxycodone and Methadone are classified as schedule II controlled substances in section 893.03(2), Florida Statutes, and have a high potential for abuse; Xanax, which is the trade name for the generic drug Alprazolam, is classified as a schedule IV controlled substance in section 893.03(4), with a low potential for abuse relative to schedule I, II, and III controlled substances. As part of his initial office visit with Dr. Christensen, A.L. signed a Pain Management Agreement, in which he agreed that, among other things, he would not take any pain medications not prescribed by Dr. Christensen or seek treatment from any other doctors in order to obtain pain medications; prescriptions would be filled at the same pharmacy, which A.L. identified as "Gordons Pharmacy"; he would take the medications prescribed in the manner indicated on the label; he agreed to random urine drug tests; and he understood he would be discharged by Dr. Christensen if he failed to abide by the Pain Management Agreement. Dr. Christensen went over this agreement with A.L. during this initial office visit, and he emphasized that the agreement was a legal document that, if breached, would result in A.L.'s being discharged as Dr. Christensen's patient. In his typed notes for A.L.'s February 12, 2007, office visit, Dr. Christensen stated: Subjective: Mr. [L] indicated on his first visit today that he is feel constant severe pain in his left knee causing him to limp which refers pain to the lower back. Mr. L additionally reports restricted movement pain localized in the right lumbar, left lumbar, right lower lumbar area, and left lower lumbar area. Mr. [L] stated that for years he is made fairly comfortably by taking pain pills but his low back pain is a lot more uncomfortable due to bending, driving, lifting, and standing. He also stated today that he is experiencing constant severe pain in the area of the left knee joint and related he has had 7 failed knee surgeries since he was 13 years old. Mr. [L] additionally made particular comment about stiffness, restricted movement, and inflexibility pain localized in the left kneecap. Mr. [L]'s knee joint pain feels worse due to bending, standing, and walking. He states that taking pain pills reduces the severity of the pain. Dr. Christensen also noted in his typed notes that A.L. rated the level of knee joint and low back pain at nine on a scale of one to ten; Dr. Christensen's handwritten notes indicate that A.L. rated the level of pain at "10+". Dr. Christensen's assessment, as reflected in his typed notes, was that A.L. showed a persistent chronic symptomatology; that is, Dr. Christensen considered A.L.'s knee and lower back pain to be a chronic and stable condition, with no hope of improvement given that A.L. rejected additional surgery on his left knee as an option. Dr. Christensen also requested at the February 12, 2007, office visit that A.L. provide him with any MRI reports or other radiologic studies as soon as possible, and A.L. provided several radiological consultation reports the day after his initial office visit. The reports included an MRI of A.L.'s left knee done on or about April 1998; an MRI of A.L.'s lumbosacral spine done on or about December 2000; an MRI of A.L.'s left knee done on February 9, 2001; an MRI of A.L.'s left knee done on August 23, 2002; and a radiological study of A.L.'s cervical spine and a CT scan of A.L.'s brain in April 2006. Dr. Christensen reviewed the reports and confirmed that A.L.'s diagnosis was an osteochondral defect of his left knee, most likely from a sports injury. Dr. Christensen did not order additional diagnostic studies of A.L.'s knee and lower back because he concluded, as a chiropractic orthopedist and based both on his objective findings from the physical examination of A.L. and on his review of the radiological reports, that A.L.'s injury would not get better on its own; that additional diagnostic tests would show only that A.L.'s condition had gotten worse; and that the results of additional diagnostic tests would not change his diagnosis or treatment of A.L. The treatment plan for A.L. that Dr. Christensen outlined in his typed notes is as follows: One month appointment is scheduled for the patient. Pain medication that he was taking was reviewed and a decreased amount of pain medicine was prescribed. He was given a book on Subutex/Suboxone. I covered our pain management agreement, cautioned of side effects, addiction, health concepts, physical therapy, patient is too young for knee replacement, etc. Our plan is to reduce the patients [sic] present intake of pain meds . . . to a lessor [sic] amount each month as we are able. Dr. Christensen believed that A.L. was taking too much pain medication. He wanted to help A.L. undo the damage that had been done by the excessive pain medications that Dr. Christensen believed had been prescribed for A.L., and Dr. Christensen planned to reduce the amount gradually to a more appropriate level of medication. Accordingly, on February 12, 2007, Dr. Christensen wrote A.L. prescriptions for 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day; 300 30-milligram tablets of Roxicodone, with instructions to take two tablets five times per day; and 60 2-milligram tablets of Xanax, with instructions to take one tablet two times per day. Based on the quantities and dosages of medications that A.L. reported he was taking as of February 12, 2007, Dr. Christensen eliminated the prescriptions for Oxycodone and Oxifast and significantly reduced the number of 30-milligram Roxicodone tablets and 40-milligram Methadone tablets A.L. could take each month. Dr. Christensen prescribed Xanax for A.L. because A.L. reported to Dr. Christensen that he had anxiety; because Dr. Christensen observed that he was anxious during the office visit and knew that pain could cause anxiety; and because A.L. reported to Dr. Christensen that he had been taking Xanax prior to February 12, 2007. Although Dr. Christensen prescribed less Xanax for A.L. than A.L. reported that he had been taking, Dr. Christensen did not want to A.L. to stop taking Xanax abruptly because A.L. could have seizures and die. The prescriptions written for A.L. by Dr. Christensen significantly decreased the amount of pain medication A.L. was reportedly taking prior to February 12, 2007, but Dr. Christensen was satisfied that the prescriptions would provide a sufficient amount of medication to control A.L.'s pain. Dr. Christensen felt that he could not refuse to prescribe pain medications for A.L. on February 12, 2007, because, once a patient has been on pain medications for years, as A.L. reportedly had, stopping the pain medications abruptly could result in very severe withdrawal symptoms. In addition, Dr. Christensen was concerned that, if he did not prescribe pain medications for A.L., A.L. would not continue his treatment with Dr. Christensen. As part of his treatment plan, Dr. Christensen also discussed with A.L. on February 12, 2007, health concepts such as improving his diet, getting exercise, considering physical therapy, setting goals, and increasing spiritual awareness. In addition, he gave A.L. information on Suboxone, a drug used primarily to prevent withdrawal symptoms when the amount of opioids such as Roxicodone is significantly reduced. Although A.L. was not interested in discussing Suboxone at the February 12, 2007, office visit, Dr. Christensen intended to continue discussing the drug with A.L. at subsequent office visits because Dr. Christensen's ultimate plan was to wean A.L. off of opioids completely. A.L. continued treatment with Dr. Christensen until June 29, 2007, seeing Dr. Christensen on March 12, 2007; April 10, 2007; May 7, 2007; June 2, 2007; and June 29, 2007. As recorded in Dr. Christensen's typed notes, A.L. complained at each office visit of "constant severe pain" in his lower back and his left knee area, with restricted movement in the lower back area and "stiffness, restricted movement, and inflexibility pain localized in the left kneecap." At each office visit, A.L. rated his knee and/or lower back pain at nine on a scale of one to ten, except that, at the office visit on May 7, 2007, A.L. rated his knee joint pain at eight on a scale of one to ten. Dr. Christensen reviewed A.L.'s systems at each office visit and conducted a physical examination focused on A.L.'s left knee and back. Dr. Christensen's assessment of A.L.'s status at each office visit was that his condition was chronic and/or stable. At A.L.'s March 12, 2007, Dr. Christensen prescribed 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day; 300 30-milligram tablets of Roxicodone, with instructions to take two tablets five times per day; and 60 2-milligram tablets of Xanax, with instructions to take one tablet two times per day. In his handwritten notes of the March 12, 2007, office visit, Dr. Christensen noted that A.L. was stable on the pain medications prescribed. On March 12, 2007, A.L. also completed a Pain Outcomes Profile, in which he rated his pain generally as five or six on a scale of one to ten; A.L. rated his level of anxiety as seven on a scale of one to ten. In his handwritten notes of the April 10, 2007, office visit, Dr. Christensen stated that he had a long discussion with A.L. about weaning him off of the pain medications and developing goals for doing so. Dr. Christensen drew a graph in his notes of the April 10, 2007, office visit to illustrate his discussion with A.L. about taking one 30-milligram Roxicodone ten times at a time instead of two. Dr. Christensen noted that A.L. wanted to take the Roxicodone tablets more often than ten times per day, and Dr. Christensen explained to A.L. that he needed to take enough pain medication to control his pain but not enough that he would go into a state of euphoria because that would lead to addiction. Dr. Christensen expanded on his point about weaning A.L. off of the large dose of Roxicodone in his typewritten notes of the April 10, 2007, office visit: I explained the concept of 2 roxicodone's [sic] (60 mg) verse [sic] 30 mg taken more often. 2 tabs can cause excess, waste, build tolerance and the patient will run out of meds. Taking the roxicone [sic] 30 mg tablets one at a time will allow the patient to dose himself better, decrease tolerance, reduce waste, laste [sic] longer. Less pain, and ultimately take less pain meds. I showed him how 240 roxies would provide more pain relief than 300 roxies if taken 1 at a time more often then [sic] taking 2 or more at a time which is how the patient was taking them. On April 10, 2007, Dr. Christensen prescribed 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day and 60 2-milligram tablets of Xanax, with instructions to take one tablet two times per day. Dr. Christensen also prescribed 300 30-milligram tablets of Roxicodone, but he instructed A.L. to take one tablet ten times per day rather than two tablets five times per day. A.L. completed a Pain Outcomes Profile at the April 10, 2007, office visit, and he rated his pain level generally at five on a scale of one to ten; A.L. rated his level of anxiety at seven on a scale of one to ten. A.L. also signed an A1A Health & Wellness Clinic Patient Informed Consent and Notice of Material Risks for Treatment of Intractable Pain with Controlled Substances on April 10, 2007, in which A.L. confirmed that Dr. Christensen had recommended and A.L. had requested treatment with opioid pain medication. By signing the form, A.L. also confirmed that he and Dr. Christensen had discussed alternative therapies, including drug cessation treatment using Suboxone and potential side effects and risks of controlled substances. At A.L.'s next office visit, on May 7, 2007, Dr. Christensen prescribed 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day and 60 2- milligram tablets of Xanax, with instructions to take one tablet two times per day. Dr. Christensen decreased A.L.'s prescription for Roxicodone from 300 30-milligram tablets to 240 30-milligram tablets, with instructions to take one tablet eight times per day. Dr. Christensen also noted in his typewritten notes that A.L. refused physical therapy and that Suboxone/Subutex was discussed with A.L. but that A.L. indicated that he was "not at all interested." At A.L.'s June 2, 2007, office visit, Dr. Christensen further reduced to 210 the number of 30-milligram Roxicodone tablets he prescribed for A.L., and he instructed A.L. to take one tablet seven times per day. Dr. Christensen noted in the Follow Up Visit form that he completed on June 2, 2007, that A.L. was not happy about the decrease in the number of Roxicodone tablets and complained that he would be in pain. Dr. Christensen noted that he explained again that the goal was to get A.L. drug-free. Dr. Christensen also discussed additional knee surgery as an option, but he noted that A.L. emphatically refused further surgery. Dr. Christensen included on the Follow Up Visit form for the June 2, 2007, office visit a notation that states in part that A.L. brought with him a "Drug Class II w/o Script (it was meds prescribed by in wrong bottle.)." There is no further explanation or mention of this in either Dr. Christensen's handwritten notes or typewritten notes for the June 2, 2007, office visit. A.L.'s final office visit to Dr. Christensen was on June 29, 2007. Dr. Christensen noted on the Follow Up Visit form that A.L. complained of knee pain that was "unbearable" at times. Dr. Christensen also noted that A.L. was experiencing increased lower back pain because he was walking with a limp. Dr. Christensen again decreased to 180 the number of 30-milligram Roxicodone tablets he prescribed for A.L., with one tablet to be taken every six hours. Dr. Christensen noted: "Patient will be underdosed but it was explain [sic] the importance of ? Roxi More H2O, reviewed [pain management] contract & goals of ? meds over time." According to the notes on the Follow Up Visit form, Dr. Christensen intended to let A.L. stabilize at 180 30-milligram Roxicodone tablets per month and to talk with A.L. again about beginning Suboxone. Dr. Christensen believed that the amount of medications that A.L. claimed to be taking at the first office visit on February 12, 2007, was clearly excessive, but he believed that A.L. was telling the truth. Although doubts about A.L.'s truthfulness regarding his medications crossed Dr. Christensen's mind, he chose to believe A.L. was telling the truth for several reasons. First, Dr. Christensen believed that a physician must assume that a patient is telling the truth, especially a complex patient like A.L., unless there is an objective reason for doubting the patient's veracity. Second, Dr. Christensen considered A.L. to be a model patient; he was clean, polite, fully alert, and competent. In addition, A.L. continued to keep his appointments with Dr. Christensen even though Dr. Christensen was decreasing the amount of Roxicodone he prescribed for A.L. each month. Third, Dr. Christensen was aware from his physical examinations of A.L. and from A.L.'s medical history that A.L. had long-standing problems with his knee that caused him pain. A.L. reported that he had been on pain medication for approximately ten years, and, even though Dr. Christensen thought the amount of medications A.L. reported he was taking at his first office visit with Dr. Christensen on February 12, 2007, was excessive, Dr. Christensen thought that A.L. could conceivably be taking the amount of pain medications he reported because, over time, A.L. probably had built up a tolerance for the pain medications and needed to take more of the medication. Dr. Christensen was concerned about the amount of pain medication A.L. reportedly was taking, however, and, therefore, one of Dr. Christensen's goals for A.L.'s treatment was to reduce the amount of pain medications A.L. was taking and, eventually, to wean him off of pain medications entirely. Fourth, an incident occurred early in his relationship with A.L. that made Dr. Christensen doubt A.L.'s veracity, but this assessment was proven wrong. Shortly after his first office visit on February 12, 2007, A.L. returned to Dr. Christensen's office and asked for a replacement prescription for Roxicodone, explaining that the prescription was in the pocket of his jeans and that the prescription had been damaged when his mother washed the jeans. Dr. Christensen thought that A.L. was simply seeking an additional amount of the pain medication. Dr. Christensen told A.L. he would have to bring in the damaged prescription, but Dr. Christensen doubted that he would do so. A.L. brought in the prescription, which had obviously been damaged, and Dr. Christensen felt badly because he had misjudged A.L. He taped the damaged prescription in A.L.'s medical file to remind himself that he should not prejudge his patients. Even though A.L. had consented to urine drug tests in the Pain Management Agreement he signed on February 12, 2007, Dr. Christensen did not order A.L. to submit to a urine toxicology screening test on his initial office visit, as a condition of Dr. Christensen's taking him on as a patient, nor did Dr. Christensen order A.L. to submit to a random urine toxicology screening test during the time A.L. was Dr. Christensen's patient. Given the extremely large amount of pain medications A.L. reported to Dr. Christensen that he had been taking prior to his first office visit on February 12, 2007, and Dr. Christensen's concern that A.L. was overmedicated, Dr. Christensen should have considered asking A.L. to submit to a urine toxicology screening test as provided in the Pain Management Agreement. Even if Dr. Christensen had administered one or more urine toxicology screening tests to A.L., however, the results of the test would have revealed only the types of drugs in A.L.'s system; that is, the urine toxicology screening test could have confirmed that A.L. was taking the medications that he reported to Dr. Christensen on February 12, 2007, and would have identified any illicit drugs he was taking at the time of the test; it would not, however, have provided any information on the quantities of drugs in A.L.'s system and, therefore, would not have confirmed the quantities of drugs A.L. reported to Dr. Christensen that he was taking at the time of his first office visit. Summary and findings of ultimate fact A few words of explanation are necessary before proceeding with the analysis of the evidence in this case. Given A.L.'s tragic death in July 2007, it is difficult for all concerned in this case to restrict their analysis of the evidence to those facts of which Dr. Christensen was aware during the time he treated A.L., yet it is essential that the evidence be viewed from this perspective. It became apparent during the course of this hearing that A.L. did not disclose certain matters to Dr. Christensen that might have changed the course of Dr. Christensen's treatment of A.L. These matters are irrelevant to the issues presented in the Department's Administrative Complaint; they are not part of the record in this case; and they have not, therefore, been considered in the preparation of this Recommended Order. Counts One and Three through Eight The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen prescribed Roxicodone, Methadone, or Xanax for A.L. inappropriately or in excessive amounts or that he breached the standard of care in prescribing these medications. The Department's expert witness testified that Dr. Christensen violated the standard of care because the combination, quantities, and dosages of the medications Dr. Christensen prescribed for A.L. were excessive. The Department's expert witness did not, however, identify the standard of care that would have governed Dr. Christensen's treatment of A.L., nor did he provide a clear explanation of the basis for his opinion that the combination, quantities, and dosages of medications Dr. Christensen prescribed for A.L. were excessive, especially considering the combination, quantities, and dosages of medications that A.L. reported to Dr. Christensen that he was taking at the time of his first office visit with Dr. Christensen. Rather, the Department's expert witness repeatedly stated his opinion, based on "his knowledge of pharmacology and more than 20 years['] experience,"5 that the prescriptions written by Dr. Christensen, if taken by A.L. as directed, would be "100 percent lethal, 100 percent of the time."6 The Department's expert witness gave no cogent explanation for his opinion that the combination, quantities, and dosages of the drugs would be 100 percent lethal, 100 percent of the time,7 which opinion, in any event, is refuted by the fact that A.L. was successfully treated by Dr. Christensen with the same combination of drugs, albeit with decreasing quantities of Roxicodone, for a period of four and one-half months.8 In addition, in formulating his opinion that the quantities and dosages of the medications Dr. Christensen prescribed for A.L. were excessive, the Department's expert witness apparently did not consider the possibility that A.L. had, over the years, developed a tolerance for these medications.9 In fact, the Department's expert witness did not give credence to A.L.'s complaints of pain; he did not believe that A.L. should have been treated with narcotics for pain; and it can reasonably be inferred from his testimony that the Department's expert witness would have refused to treat A.L. The Department's expert witness dismissed A.L.'s complaints of pain as not credible, stating that "[t]he patient is extremely young to have any pain complaints."10 The Department's expert witness testified that, if he had been consulted, he "would have recommended a trial of spinal cord stimulation"; that Dr. Christensen could have "prescribe[d] an appropriate brace for the knee"; or that Dr. Christensen might have chosen "to then make a referral to an orthopedic surgeon" for surgery on A.L.'s knee.11 The testimony of the Department's expert witness as to the treatment he would have provided to A.L. was repeatedly conditioned by the word "if"; if A.L.'s reported knee problem were confirmed, and if the Department's expert witness had agreed to treat A.L. In fact, on the basis of the written medical records alone, the Department's expert witness dismissed A.L. as "a liar and probably a substance abuser and certainly diverting his medication" and labeled as "outlandish" A.L.'s "self reported history of medication and prescription" and his "claims of being prescribed high dosages and lethal quantities" of controlled substances.12 In rendering his opinion that the combination, quantities, and dosages of the medications Dr. Christensen prescribed for A.L. were excessive and in violation of the standard of care, the Department's expert witness did not acknowledge in his testimony that Dr. Christensen considered the quantities, dosages, and number of different pain medications that A.L. reported on his first office visit to be excessive; that Dr. Christensen concluded that A.L. was overmedicated; that Dr. Christensen's treatment plan focused on decreasing the quantity of medications prescribed for A.L.; that Dr. Christensen did, in fact, refuse to write A.L. prescriptions for Oxycodone and Oxifast; that, at A.L.'s first office visit, Dr. Christensen wrote prescriptions for Roxicodone and Methadone for A.L. that were for quantities substantially smaller than those A.L. reportedly was taking; that Dr. Christensen assumed that A.L. was truthful when he reported that he was taking 60 to 90 two-milligram Xanax; that Dr. Christensen could not eliminate Xanax from the prescriptions he wrote for A.L. because abrupt withdrawal from Xanax could cause death; that Dr. Christensen reduced by one-third the number of two-milligram Xanax he prescribed for A.L.; that Dr. Christensen introduced at A.L.'s first office visit the possibility of A.L.'s using Suboxone to help in weaning him off of opioid analgesics such as Roxicodone and Methadone; that Dr. Christensen steadily decreased the quantity of Roxicodone he prescribed for A.L., until the amount was substantially less than the amount A.L. reportedly was taking at the time of his first office visit with Dr. Christensen. By failing to indicate that he considered these factors in rendering his opinions and by making the broad and unsupported assertion that the medications prescribed by Dr. Christensen for A.L. were 100 percent lethal, 100 percent of the time, the Department's expert witness substantially diminished the credibility of his opinions. Rather than taking an objective view of the treatment that Dr. Christensen provided A.L. from February 12, 2007, to June 29, 2007, the Department's expert witness demonstrated throughout his testimony a disdain for Dr. Christensen as a physician. This disdain for Dr. Christensen is made particularly clear when the Department's expert witness attributed to Dr. Christensen a purely economic motive in his treatment of A.L. The Department's expert witness testified that Dr. Christensen, in common with "most pill mills or physicians like the subject," had "a huge economic incentive" for his treatment of A.L.13 These statements demonstrated a bias against Dr. Christensen that substantially diminished the credibility of his testimony, in general, for the following reasons. First, there was no allegation in the Administrative Complaint and no evidence in this record to support the categorization of Dr. Christensen by the Department's expert witness as a physician associated with a "pill mill." Second, in reaching his conclusion that Dr. Christensen's motivation for treating A.L. was purely financial, the Department's expert witness assumed, in the absence of even a scintilla of evidence in this record, that Dr. Christensen required his patients to pay a substantial amount of cash for each office visit and that Dr. Christensen was a "dispensing physician," that is, a physician who sells drugs as well as prescribing them.14 Count Two In Count Two of the Administrative Complaint, the Department charged Dr. Christensen with violating the standard of care in four respects, which are discussed in detail below. Failure to diagnose a history of anxiety The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to diagnose a history of anxiety to support prescribing Alprazolam."15 Dr. Christensen noted on the New Patient History Form completed during A.L.'s first office visit on February 12, 2007, that A.L. reported a history of anxiety as a psychiatric condition, and A.L. also reported that he was currently taking Alprazolam, or Xanax. On each of A.L.'s subsequent office visits to Dr. Christensen, A.L. reported on the Pain Outcomes Profile that he had significant feelings of anxiety, and Dr. Christensen observed that A.L. exhibited anxious behaviors during his office visits. The Department's expert witness apparently overlooked this information in Dr. Christensen's medical records because he testified that he could find no justification for prescribing Alprazolam for A.L.16 Failure to order urine toxicology screening test The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to order screening urine toxicology to rule out usage of illicit substances or confirm usage of prescribed medications." The Department's expert witness identified the standard of care at the times pertinent to this proceeding as requiring patients to submit to intermittent urine toxicology screening studies so that the patient wouldn't know when such testing would take place. The Department's expert witness further explained that it was always a matter of clinical judgment as to when to require a patient to submit to a urine toxicology screening study, even to a patient such as A.L., who had reported taking a large quantity of pain medications at the time of his first office visit to Dr. Christensen. The Department's expert witness testified that, given the amount of pain medications A.L. reported to Dr. Christensen that he was taking at the time of A.L.'s first office visit, a urine toxicology screening study of A.L. at the first office visit would be "indicated," but the Department's expert witness did not testify that Dr. Christensen violated the standard of care by failing to require A.L. to submit to such a study at that first office visit or during the time he was treating A.L. In fact, according to Dr. Christensen's expert witness, at the times pertinent to this proceeding, it would not be within the standard of care to require a patient to submit to a urine toxicology screening study within the first four and one-half months of treatment.17 Finally, there is no indication in the record that Dr. Christensen had any reason to suspect that A.L. was taking illicit substances; the primary concern Dr. Christensen, and the Department's expert witness, had with respect to A.L. was the quantity of pain medications he was reportedly taking at the time of his first office visit. Because a urine toxicology screening study reveals only the types of substances in the urine and not the quantity of such substances, a urine toxicology screening study would not have revealed whether A.L. was lying about the quantities of pain medications he reported to Dr. Christensen on his first office visit, as was concluded by the Department's expert witness; such a study would have revealed only whether A.L. was, in fact, taking these substances, a concern that, based on the information available to him, Dr. Christensen did not have at A.L.'s first or subsequent office visits. According to the standard of care identified by the Department's expert witness, Dr. Christensen did not deviate from this standard of care by using his clinical judgment to decide not to require A.L. to submit to a urine toxicology screening study. Failing to refer A.L. for treatment for substance abuse The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to refer Patient A.L. to a psychiatrist and/or addiction specialist and/or rehabilitation center for substance abuse." The only mention of Dr. Christensen's failure to refer A.L. to a psychiatrist, addiction specialist, or rehabilitation center in the testimony of the Department's expert witness was in answer to the question of the Department's counsel: "Would respondent's failure to do so in this case fall below the standard of care?" The Department's expert witness answered: "Given his [A.L.'s] claims of previous medication prescription and usage, yes."18 The Department's expert witness never defined the standard of care to which he was referring, and his opinion, therefore, is not persuasive on this issue.19 Failure to order diagnostic tests The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to order diagnostic tests to justify the course of treatment for patient A.L." The Department's expert witness testified that he would "not be prepared to say that [Dr. Christensen's failure to order a diagnostic test to justify his course of treatment for A.L. fell below the standard of care] because there's no justification for the course of treatment regardless of any study or consultation that the subject could have initiated."20 There was no allegation in the Administrative Complaint that Dr. Christensen violated the standard of care because there was no justification for the treatment he provided A.L., and this testimony is irrelevant to a determination of whether Dr. Christensen should have ordered additional diagnostic tests for A.L. The Department's expert witness did, however, go on to state that, under the circumstances of this case, "a reasonable and prudent physician . . . should have, at the very least, ordered an MRI study of the knee, [and] performed a comprehensive physical examination of the effected [sic] joint" and that "many physicians would have ordered an MRI of the knee or at the very least, perform [sic] a very detailed and well documented physical examination and then written down his treatment plan and the justification for his treatment plan."21 To the extent that this testimony constitutes the articulation of the standard of care by the Department's expert witness, the opinion of the Department's expert witness that Dr. Christensen fell below this standard of care is unsupportable for two reasons. First, the Department's expert witness incorrectly identified the report of the MRI of A.L.'s knee done in 1998 as the only MRI report in Dr. Christensen's medical records. The Department's expert witness overlooked the report in Dr. Christensen's medical records of the post-surgical MRI done of A.L.'s left knee on August 23, 2002, four and one-half years before A.L.'s first office visit to Dr. Christensen in February 2007. Therefore, the opinion of the Department's expert witness that Dr. Christensen fell below the standard of care for failing to order an MRI is not persuasive because it is based on the incorrect assumption that the most recent MRI of A.L.'s knee was done nine years prior to his first office visit with Dr. Christensen. Second, Dr. Christensen did a comprehensive physical examination of A.L.'s left knee joint. Dr. Christensen, aided by his background in chiropractic orthopedics, performed several tests on A.L.'s left knee, which, together with the post- operative MRI done in August 2002, led him to the conclusion that, if anything, the condition of A.L.'s left knee would not have improved, and probably would have worsened, over the intervening years. Dr. Christensen documented the results of the examination in the typed notes he prepared on February 12. 2007, and set out his diagnosis and treatment plan for A.L. Therefore, the opinion of the Department's expert witness that Dr. Christensen fell below the standard of care for failing to conduct a comprehensive physical examination of A.L.'s left knee and to document the results of the examination and the treatment plan for A.L. is unpersuasive because the Department's expert witness apparently overlooked this information in A.L.'s medical records.22
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint filed against John Christensen, M.D., by the Department of Health. DONE AND ENTERED this 28th day of June, 2011, in Tallahassee, Leon County, Florida. S Patricia M. Hart Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of June, 2011.
The Issue The issue in this case is whether Florida Administrative Code Rule 64B16-27.500(6) regarding the negative drug formulary is an invalid exercise of delegated legislative authority within the meaning of Subsection 120.52(8), Florida Statutes (2007).1
Findings Of Fact Levothyroxine Sodium is a drug used to treat Hypothyroidism and Pituitary TSH Suppression. Mylan develops, manufactures, and sells generic pharmaceuticals and is licensed as a non-resident prescription drug manufacturer and an out-of-state prescription drug wholesaler in Florida pursuant to Section 499.01, Florida Statutes. Mylan has received approval from the United States Food and Drug Administration (FDA) to market 12 strengths of generic Levothyroxine Sodium tablets, which the FDA has determined to be bioequivalent and therefore therapeutically equivalent to corresponding strengths of four reference listed drugs2: Unithorid® tablets, Synthroid® tablets, Levoxyl® tablets, and Levothroid® tablets. Abbott is the manufacturer of Synthroid®, a Levothyroxine Sodium product marketed in Florida and other places. The Board of Pharmacy “has authority to adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of [Chapter 465] conferring duties upon it.” § 465.005, Fla. Stat. Subsection 465.025(6), Florida Statutes, provides: The Board of Pharmacy and the Board of Medicine shall establish by rule a formulary or generic drug type and brand name drug products which are determined by the boards to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, would pose a threat to the health and safety of patients receiving prescription medication. Subsection 465.025(1)(a), Florida Statutes, defines “brand name” as “the registered trademark name given to a drug product by its manufacturer, labeler, or distributor.” “Generically equivalent drug product” is defined in Subsection 465.025(1)(b), Florida Statutes, as “a drug product with the same active ingredient, finished dosage form, and strength.” Subsection 465.025(2), Florida Statutes, provides: A pharmacist who receives a prescription for a brand name drug shall, unless requested otherwise by the purchaser, substitute a less expensive, generically equivalent drug product that is: Distributed by a business entity doing business, and subject to suit and service of legal process, in the United States; and Listed in the formulary of generic and brand name products as provided in subsection (5) for the brand name drug prescribed unless the prescriber writes the words “MEDICALLY NECESSARY,” in her or his own handwriting, on the face of a written prescription; unless, in the case of an oral prescription, the prescriber expressly indicates to the pharmacist that the brand name drug prescribed is medically necessary; or unless, in the case of a prescription that is electronically generated and transmitted, the prescriber makes an overt act when transmitting the prescription to indicate that the brand name drug prescribed is medically necessary. When done in conjunction with the electronic transmission of the prescription, the prescriber’s overt act indicates to the pharmacist that the brand name drug prescribed is medically necessary. Subsection 465.025(5), Florida Statutes, provides: Each community pharmacy shall establish a formulary of generic and brand name drug products which, if selected as the drug product of choice, would not pose a threat to the health and safety of patients receiving prescription medication. In compiling the list of generic and brand name drug products for inclusion in the formulary, the pharmacist shall rely on drug product research, testing, information, and formularies compiled by other pharmacies, by states, by the United States Department of Health, Education, and Welfare, by the United States Department of Health and Human Services, or by any other source which the pharmacist deems reliable. Each community pharmacy shall make such formulary available to the public, the Board of Pharmacy, or any physician requesting same. The formulary shall be revised following each addition, deletion, or modification of said formulary. If a brand name drug or a generic drug type drug product is listed on the negative drug formulary established by the Board of Pharmacy and Board of Medicine, a pharmacist is prohibited from substituting a generically equivalent drug product for a prescribed brand name drug product. § 465.025(6)(b), Fla. Stat. The Board of Pharmacy has adopted a negative drug formulary which is contained in Florida Administrative Code Rule 64B16-27.500, and Levothyroxine Sodium is listed on the negative drug formulary. Thus, Mylan’s generic products currently cannot be substituted where a prescription is written for a brand name Levothyroxine Sodium product. Mylan has challenged Florida Administrative Code Rule 64B16-27.500(6), which provides: The negative drug formulary is composed of medicinal drugs which have been specifically determined by the Board of Pharmacy and the Board of Medicine to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, could produce adverse clinical effects, or could otherwise pose a threat to the health and safety of patients receiving such prescription medications. Except where certain dosage forms are included on the negative drug formulary as a class, all medicinal drugs are listed by their official United States Pharmacopoeia Non-Proprietary (generic) name. The generic name of a drug shall be applicable to and include all brand-name equivalents of such drug for which a prescriber may write a prescription. Substitution by a dispensing pharmacist on a prescription written for any brand name equivalent of a generic named drug product listed on the negative drug formulary or for a drug within the class of certain dosage forms as listed, is strictly prohibited. In cases where the prescription is written for a drug listed on the negative drug formulary but a name brand equivalent is not specified by the prescriber, the drug dispensed must be one obtained from a manufacturer or distributor holding an approved new drug application or abbreviated new drug application issued by the Food and Drug Administration, United States Department of Health and Welfare permitting that manufacturer or distributor to market those medicinal drugs or when the former is not applicable, those manufacturers or distributors supplying such medicinal drugs must show compliance with other applicable Federal Food and Drug Administration marketing requirements. The following are included on the negative drug formulary: * * * (6) Levothyroxine Sodium. Subsection 465.0251(1), Florida Statutes, provides: The Board of Pharmacy and the Board of Medicine shall remove any generic named drug product from the formulary established by s. 465.025(6), if every commercially marketed equivalent of that drug is “A” rated as therapeutically equivalent to a reference listed drug or is a reference listed drug as referred to in “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) published by the United States Food and Drug Administration. The Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act. It also includes therapeutic equivalence evaluations for approved multisource prescription drug products. The Orange Book is updated annually and is supplemented with monthly cumulative updates. Additionally, the FDA has a website containing an electronic version of the Orange Book, which is also updated. The Orange Book used in 2007 is the 27th Edition. The Orange Book in effect at the date of the enactment of Section 465.0251, Florida Statutes,3 was the 21st Edition. Generally, approval by the FDA is required before a prescription drug product may be marketed, distributed, or sold in the United States. See 21 U.S.C. § 355(a). When a product contains a new active ingredient or otherwise differs significantly from previously approved products, the sponsor must provide the FDA with data demonstrating the product’s safety and effectiveness for the intended use. See, e.g., 21 U.S.C. § 355(b). When a product is a copy of a previously approved product—-what is commonly called a “generic” version of the original drug—-proof of safety and effectiveness is not required. Instead, the FDA requires a showing that, with regard to certain characteristics, the proposed generic product is essentially the same as the approved product it purports to copy, which is called the “reference listed drug.” See 21 U.S.C. § 355(j). The FDA’s previous finding that the reference listed drug is safe and effective is then imputed to the generic product. In general, the generic product must contain the same active ingredient in the same strength, and it must be in the same dosage form (e.g., tablet, capsule, solution) as the reference listed drug. See 21 U.S.C. § 355(j). Products that share these characteristics are considered “pharmaceutical equivalents” by the FDA. Orange Book, 27th Ed., at v-vi (Jan. 2007). Subsection 465.025(1)(b), Florida Statutes, uses the term “generically equivalent drug products” to describe such products. “Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.” Orange Book, 27th Ed. at vi. The FDA classifies as therapeutically equivalent those products that meet the following criteria: they are approved as safe and effective; they are pharmaceutical equivalents in that they (a) contain identical amounts of the same active drug ingredient in the same dosage form and same route of administration, and (b) meet compendial or other applicable standards of strength, quality, purity, and identity; (3) they are bioequivalent in that (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard; (4) they are adequately labeled; (5) they are manufactured in compliance with Current Good Practice Manufacturing Practice regulations. Id. These criteria are essentially the same criteria that existed in 2001 as shown in the final staff analysis of HB69, which was passed and became Chapter 2001-146, Laws of Florida, now codified as Section 465.0251, Florida Statutes. Drug products that have been relied on as reference listed drugs are so identified in the Orange Book, and products that are therapeutically equivalent to each other are identified by a shared therapeutic equivalence evaluation code (TE code). These are primarily, but not exclusively, reference listed drugs and the generic drugs approved on the grounds of pharmaceutical equivalence and bioequivalence to those reference listed drugs. Generally, the FDA uses a two-letter TE code, with a code of “AB” given to solid oral dosage form products that have demonstrated therapeutic equivalence. Orange Book, 27th Ed. at xii-xiii. For the vast majority of most multi-source drugs, there is one product that is the reference listed drug and one or more generic versions of that product, and all the products share a TE code of AB. However, there are situations in which there is more than one reference listed drug. These situations are discussed in the Orange Book, 27th Ed. at xiv. In certain instance, a number is added to the end of the AB code to make a three character code ( i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. . . . Drugs coded as AB under a heading are considered therapeutically equivalent only to other drugs coded as AB under that heading. Drugs coded with a three-character code under a heading are considered therapeutically equivalent only to other drugs coded with the same three- character code under that heading. The FDA first officially described the three-character code rating system in the 16th edition of the Orange Book in 1996. Levothyroxine Sodium tablets are a drug product for which there are multiple reference listed drugs. Currently the Orange Book identifies seven Levothyroxine Sodium products approved for sale in the United States: Synthroid®, Levo-T®, Levoxyl®, Levothroid®, Unithroid®, a generic-named product manufactured by Genpharm, and a generic manufactured by Mylan. The current Orange Book also contains the following levothyroxine sodium products in a section identifying “Discontinued” products that, although approved for distribution in the United States, are not being marketed: Novothyrox, Levolet, and Tirosint. The following drug products are currently identified in the Orange Book as reference listed drugs: Synthroid®, Levo-T®, Levoxyl®, Levothroid®, and Unithroid®. In the case of Levothyroxine Sodium products, not all the reference listed drugs are considered therapeutically equivalent to one another. The Orange Book discusses this situation and explains the therapeutic evaluations for Levothyroxine Sodium products as follows: Because there are multiple reference listed drugs of levothyroxine sodium tablets and some reference listed drugs’ sponsors have conducted studies to establish their drugs’ therapeutic equivalence to other reference listed drugs, FDA has determined that its usual practice of assigning two or three character TE codes may be potentially confusing and inadequate for these drug products. Accordingly, FDA provides the following explanation and chart of therapeutic equivalence evaluations for levothyroxine sodium products. Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Unithroid (Jerome Stevens NDA 021210) tablets. Levo-T (Alara NDA 021342), Levothyroxine Sodium (Mylan ANDA 76187), Unithroid (Jerome Stevens NDA 021210) and Levothyroxine Sodium (Genpharm ANDA 76752) tablets have been determined to be therapeutically equivalent to corresponding strengths of Synthroid (Abbott NDA 021402) tablets. Levo-T (Alara NDA 021342), Unithroid (Jerome Stevens NDA 021210), Levothyroxine Sodium (Mylan ANDA 076187) and Levothyroxine Sodium (Genpharm ANDA 76752) tablets have been determined to be therapeutically equivalent to corresponding strengths of Levoxyl (King/Jones Pharma NDA 021301) tablets. Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Levothroid (Lloyd NDA 021116) tablets. Novothyrox (Genpharm NDA 021292) requires further investigation and review to establish therapeutic equivalence to corresponding strengths of any other Levothyroxine Sodium drug products and is rated BX. Levolet (Vintage NDA 021137) requires further investigation and review to establish therapeutic equivalence to corresponding strengths of any other Levothyroxine Sodium drug products and is rated BX. The chart outlines TE codes for all 0.025mg products with other products being similar. Therapeutic equivalence has been established between products that have the same AB+number TE code. More than one TE code may apply to some products. One common TE code indicates therapeutic equivalence between products. Trade Name Applicant Potency TE CODE Appl No Product No UNITHROID STEVENS J 0.025mg AB1 21210 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB1 76187 001 LEVOXYL JONES PHARMA 0.025mg AB1 21301 001 SYNTHROID ABBOTT 0.025mg AB1 21402 001 SYNTHROID ABBOTT 0.025mg AB2 21402 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB2 76187 001 LEVO-T ALARA PHARM 0.025mg AB2 21342 001 UNITHROID STEVENS J 0.025mg AB2 21210 001 LEVOTHYROXINE SODIUM GENPHARM 0.025mg AB2 76752 001 LEVOXYL JONES PHARMA 0.025mg AB3 21301 001 LEVO-T ALARA PHARM 0.025mg AB3 21342 001 UNITHROID STEVENS J 0.025mg AB3 21210 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB3 76187 001 LEVOTHYROXINE SODIUM GENPHARM 0.025mg AB3 76752 001 LEVOTHROID LLOYD 0.025mg AB4 21116 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB4 76187 001 NOVOTHYROX GENPHARM 0.025mg BX 21292 001 LEVOLET VINTAGE PHARMS 0.025mg BX 21137 001 Orange Book, 27th Ed. at xix-xx. In the Orange Book, 21st Ed. (Cumulative Supplement 6, June 2001), only two Levothyroxine Sodium tablet products were listed, Levoxyl® and Unithroid®, and both were rated as BX, meaning that the data that had been reviewed by FDA was insufficient to determine therapeutic equivalence. There were also 12 additional Levothryroxine Sodium products that were being commercially marketed in the United States and were not listed in the Orange Book.
Findings Of Fact The parties stipulated that Monroe C. Schiffman is a pharmacist licensed by the Florida Board of Pharmacy. They further stipulated that Sharon Drugs, Inc. d/b/a Mercy Professional Building Pharmacy is located at 3661 South Miami Avenue, Miami, Florida and that Sharon Drugs, Inc. owns and operates Mercy Professional Building Pharmacy. The parties also stipulated that Monroe C. Schiffman was a corporate officer and share holder in Sharon Drugs, Inc., a Florida corporation, from March, 1974 until the audits in question. An inspection and audit of Monroe Drugs, Inc. d/b/a Morris Drugs and Monroe Schiffman and Sharon Schiffman, was begun on May 5, 1976 and lasted several days. The audited period was from July 1, 1974 until May 5, 1976 during which dates Monroe C. Schiffman was a corporate officer and stockholder in Morris Drugs, Inc. The procedures for the audits were to assume a zero stockage as of July 1, 1974 and to account for the drugs received after that date. The drugs audited were controlled drugs as defined by Chapter 893, Florida Statutes. These drugs were chosen for audit because complete records of their order, receipt and dispensing must be kept pursuant to Chapter 893, Florida Statutes. Exhibit 2, a summary of the audit of Morris Drugs, Inc., was identified by the Board's agent, Vernon K. Bell, as the summary of the discrepancies in controlled drugs revealed by the audit which he conducted. The audit conducted by Vernon K. Bell revealed a shortage of controlled drugs for which no records had been kept of 157,569 total units or pills. The drugs audited were Desoxyn (methamphetamine hydrochloride), Percodan (Oxycodone hydrochloride), Quaalude (methaqualone), Biphetamine (d- and dl-Amphetamine), Eskatrol Spansule (dextroamphetamine sulfate and prochlorperazine), Tuinal (sodium amobarbital and sodium secobarbital), Seconal (sodium secobarbital), Dexedrine (dextroamphetaimine sulfate), Nembutal (sodium pentobarbital), Dilaudid (hydromorphone), Amytal (amobarbital), and Dexamyl (dextroamphetamine sulfate). The records required to be kept by law of the dispensing of controlled drugs were not kept by the permittee, Monroe Pharmacy, Inc. d/b/a Morris Drugs and Monroe Schiffman and Sharon Schiffman.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the permit of Monroe Pharmacy, Inc. d/b/a Morris Drugs and Monroe Schiffman and Sharon Schiffman be revoked. DONE and ORDERED this 5th day of January, 1977 in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings Room 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Michael Schwartz, Esquire Suite 201 Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 Gerald Kogan, Esquire Suite 500 Security Trust Building 700 Brickell Avenue Miami, Florida 33131 H. F. Bevis, Executive Secretary State Board of Pharmacy 252 East Sixth Avenue Box 3355 Tallahassee, Florida 32303
Findings Of Fact The Petitioner is the Department of Professional Regulation, Board of Pharmacy. Petitioner seeks to suspend, revoke or take other disciplinary action against the Respondents. Respondent BGJM, Inc. (hereinafter "Save-on Drugs") holds Permit No. 7171 located at 4282 North State Road 7, Lauderdale Lakes, Florida. Save on Drugs has held said permit at all times material hereto. Respondent Robert E. Levy holds Pharmacy License No. 0017283 and has held said license at all times material hereto. Respondent Levy operated Save on Drugs as the sole proprietor and is the only pharmacist employed at the aforementioned store. Respondent Levy, while working at Save on Drugs, between the dates October 16, 1981 and April 2, 1982, dispensed approximately 139,000 Methaqualone tablets on 3,136 prescriptions. Respondent Levy ceased dispensing Methaqualone tablets approximately three (3) weeks prior to the institution of Petitioner's investigation of Respondent Levy's dispensing of controlled substances. The Respondent dispensed, over a three-month period, some 57,250 units of Methaqualone on behalf of one practitioner, a Dr. Lena. A specific breakdown of Dr. Lena's prescribing activity for part of the relevant period is as follows: DATE PHARMACY DRUG AMOUNT SCRIPT 12/14/81 Save-On Quaa-300 mg. 630 14 12/15 Save-On 720 16 12/16 Save-On 495 11 12/17 Save-On 765 17 12/18 Save-On 1,440 32 12/21 Save-On 945 21 12/22 Save-On 1 x 30 mg. 675 15 12/23 Save-On incl. 1,080 24 12/24 Save-On 1,215 27 12/28 Save-On 1,035 23 12/29 Save-On 1,305 29 12/30 Save-On 1,575 35 12/31 Save-On 1,305 29 Totals 13,185 293 The numerous prescriptions introduced into evidence by the Petitioner reflect circumstances where Respondent Levy failed to properly initial and date Schedule II prescriptions as they were filed. As example, Petitioner offered the following: prescription Nos. 48854, 48052, 50189, 48068, 48856, 48912 and 48905. Louis Fisher 2/ , an employee of the Department of Justice, Drug Enforcement Administration, since approximately November, 1971, has been involved with the regulation of controlled substances. Mr. Fisher works with doctors as well as pharmacists at the retail level. Mr. Fisher is a registered pharmacist and has been charged with drafting regulations for controlled substances. Without question, Methaqualone is a Schedule II drug and is a sedative and hypnotic agent. The drug has a high abuse potential. During the summer of 1982, Methaqualone was changed from Schedule II to a Schedule I controlled substance. After being provided with a hypothetical situation giving the number of prescriptions that Respondent Levy had filled during the time period involved, Mr. Fisher concluded that a pharmacist filling the number of prescriptions within the time period as is here involved by Respondent Levy was, in Mr. Fisher's opinion, unprofessional, excessive, outside the course of good professional practices, and not conduct amounting to professional practice in the patients' best interest. 3/ Dr. Lena was employed by Northeast Medical Services, a stress clinic. In this regard, the parties stipulated that all the prescriptions involved herein were written by a licensed medical doctor. Daniel O'Connell, an investigator with the Department of Professional Regulation, visited the Respondent's store during approximately October 1981, and performed a routine change of ownership inspection. At that time, Respondent Levy engaged in a conversation with investigator O'Connell at which time Respondent Levy was apprised of the problem with respect to dispensing Methaqualone in the south Florida area. Jim R. Golden, an investigator with the Department of Professional Regulation since approximately September 1981, visited Respondent Levy's store during April 1982, to perform a routine inspection to determine the amount of Schedule II drug prescriptions that Respondent was filling. Investigator Golden reviewed a large number of prescriptions that were filled by Respondent for Dr. Lena and inquired of Respondent the reason for dispensing such a large number of prescriptions for Methaqualone tablets. Respondent Levy replied that it was the "money end of it" and that he (Respondent) could fill six (6) Methaqualone prescriptions and do better with those prescriptions from a profit viewpoint than he could with the remainder of his other prescribing activities in the store for the remainder of any given day. Further, Respondent related that he hand to do extensive repairs to make the store operational. (Testimony of Investigator Golden)
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED: That Respondent BGJM, Inc.'s Permit No.7171 be REVOKED. That Respondent Robert E. Levy's Pharmacy License No. 0017283 be placed on probation for a period of two (2) years. RECOMMENDED this 12th day of May, 1983, in Tallahassee, Florida. JAMES E. BRADWELL, 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 12th day of May, 1983.
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)
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.
