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 issues are whether Respondent is guilty of: 1) failing to practice medicine within the applicable standard of care, as required by section 458.331(1)(t), Florida Statutes, by inappropriately and excessively prescribing one or more controlled substances and 2) failing to keep medical records that justify the course of treatment for prescribing one or more controlled substances, as required by section 458.331(1)(m), Florida Statutes, by failing to document patient histories, examination results, test results, results of drugs prescribed, dispensed or administered, or reports of consultations or hospitalizations, or failing to justify the amount and dosage of pills prescribed.
Findings Of Fact Introduction At all material times, Respondent has been a physician licensed to practice medicine in Florida. His license number is ME 33389. His practice is located in Delray. Respondent is not Board certified in any specialty. He appears to have practiced for many years. In 1987, Respondent was disciplined for a failure to keep medical records. The Board of Medicine reprimanded Respondent, imposed $2000 of costs and one year's probation, required 30 hours' coursework in risk management and recordkeeping, and restricted Respondent's license by requiring the submission of quarterly reports covering prescribing activities, among other things. In 2007, Respondent was disciplined for a violation of the requirements imposed on a dispensing practitioner. The Board of Medicine imposed a fine and probation. The Board also required a drug course, a law and rules course, ten hours' coursework in the responsibilities of dispensing practitioners and 25 hours' community service. This case involves Respondent's use of chronic opioid therapy for chronic and breakthrough pain not associated with cancer or other terminal disease. As detailed in the Conclusions of Law, the issues require consideration of whether Respondent's medical records are adequate to justify these prescriptions and whether these prescriptions are inappropriate, excessive, or otherwise unjustified, so as to violate the applicable standard of care. In attempting to prove these two sets of violations, Petitioner has limited its allegations to Respondent's prescriptions of five Schedule II controlled substances and one Schedule III controlled substance. The five Schedule II controlled substances are oxycodone, roxicodone, Oxycontin®, Oxyfast®, and Percocet®. The lone Schedule III controlled substance is Norco®. A Schedule II controlled substance has a high potential for abuse and has a currently accepted, but severely restricted, medical use in treatment in the United States. Abuse of a Schedule II controlled substance may lead to severe psychological or physical dependence. A Schedule III controlled substance has a lower potential for abuse and a currently accepted medical use in treatment in the United States. Abuse of a Schedule III controlled substance may lead to moderate or low physical dependence or high psychological dependence. People have used opium for pain relief for thousands of years. The pharmacological production of opioid drugs started after the identification of the morphine alkaloid in 1806. By the end of the 19th century, in the United States, legal controls were imposed on opioids. By the 1940s, opioids could be legally used only if prescribed by physicians, pursuant to strict regulatory controls. By the end of the 20th century, tension had emerged between physicians reluctant to prescribe opioids due to professional-liability considerations and advocates of pain control. Particularly contentious issues are whether and how to prescribe opioid therapy for chronic pain not associated with terminal disease. Oxycodone and hydrocodone are short-acting opioids with an onset of 30-90 minutes and duration of 4-6 hours. Roxicodone is oxycodone hydrochloride. In controlled-release form, such as Oxycontin®, oxycodone hydrochloride is a long-acting opioid with an onset of 1-12 hours and duration of 8-72 hours. With a quicker onset than oxycodone in pill form, Oxyfast® is a liquid containing 20 mg of oxycodone hydrochloride in a one-ml bottle. Percocet® is oxycodone and acetaminophen: a dosage of "10/325" is 10 mg of oxycodone and 325 mg of acetaminophen. Norco® is hydrocodone and acetaminophen: a dosage of "10/325" is 10 mg of hydrocodone and 325 mg of acetaminophen. Methadone is an inexpensive synthetic opioid with long- acting effect. The half-life of methadone typically ranges from 15-60 hours, but may extend to 120 hours. The long, variable half-life of Methadone discourages its wider use in pain control because of difficulties in maintaining not more than therapeutic levels. During the time in question, Oxycontin® was relatively expensive among the opioids listed in the preceding paragraph. At that time, one 30-mg roxicodone pill cost an uninsured patient about $0.70-$1.00, one 40-mg Oxycontin® pill cost an uninsured patient about $8.00, and one 80-mg Oxycontin® pill cost an uninsured patient about $14.00. The record does not reliably establish street values for these drugs, but all of them were traded and consumed at high rates illegally on the street. Short-acting opioids are more appropriate for breakthrough pain, which is a temporary spike in pain above chronic-pain levels due, for example, to physical exertion. A short-acting opioid is well-matched to the relatively short duration of breakthrough pain. This record does not permit resolution of the dispute over whether long-acting opioids are more effective than short-acting opioids for the relief of chronic pain. Generally, prescribed opioids pose distinct risks of consumption and diversion by the patient. For the opiate-naïve patient, doses of opioids that may be easily tolerated by the opiate-tolerant patient may cause potentially life-threatening side effects, including respiratory depression. For the opioid- tolerant patient who is consuming opioids not prescribed by the practitioner--from other, undisclosed practitioners or from street purchases--additional doses of prescribed opioids may cause the same life-threatening side effects as those faced by the opiate-naïve patient, although, with controlled dosing among opioid-tolerant patients, opioids typically may be increased until pain control is attained. Pain medicine practitioners may manage these risks, in part, by administering periodic urinalyses to their patients. The urinalyses administered to the ten patients in this case were threshold tests that would detect the presence of various substances above a certain level. Such tests would uncover opioid-naïve patients and patients consuming other controlled substances, but not the level of any controlled substance detected by the test. Sometimes, opioid rotation may achieve the desired analgesic effect at relatively low doses. Otherwise, chronic pain may require increasing doses of the same opioid to obtain the same relief originally obtained by lower doses, although some patients may find effective relief for extended periods at a dosing level that is not increased. Less frequently, higher opioid doses may produce hyperalgesia. Optimally, effective pain management is multifaceted, including such disciplines or techniques as psychotherapy, cognitive behavioral therapy, biofeedback, relaxation techniques, physical therapy, and reliance on nonopioid analgesics. But limits on insurance coverage or lack of insurance and the relatively high costs of most of these alternative disciplines or techniques may legitimately require the practitioner to rely more on the relatively inexpensive opioids. Even Petitioner's expert witness admitted, "Sometimes I have self-pay patients who are on opiates only because they can't afford anything else." (Pet. Ex. 4, p. 7.) Petitioner's expert acknowledged that roxicodone "is something you tend to give people who have no insurance." (Tr., p. 85.) Cost considerations may also require that the practitioner break down what would be a single prescription of, say, 100 pills into two prescriptions of 50 pills each, so the patient can effectively pay for his prescription in two installments. Again, Petitioner's expert witness admitted that there was nothing wrong with this practice. (Pet. Ex. 4. p. 41.) None of the ten patients addressed in this case had insurance during the relevant period. (One patient potentially had COBRA coverage that would have expired long before the period in question.) Although at least a couple of patients were employed in professions in which at least moderate earnings might be expected, the record does not reliably describe the financial resources of any of the ten patients. The record contains no evidence of injury to the patients discussed below in terms of the care, including prescribed opioids, that they received from Respondent. Excessive consumption of prescribed or diverted opioids is dangerous and can be fatal. But, as Respondent's expert witness testified, the fatal combination seen "excessively" in the eight deaths per day in Florida from prescription drug abuse is opioids; benzodiazepines, such as Xanax®; and muscle relaxants, such as Soma®. Although Respondent prescribed medications in all three categories, Petitioner has not alleged any violations arising from Respondent's prescriptions of any drug besides the opioids discussed above, so Respondent's prescriptions of benzodiazepines and muscle relaxants to these ten patients are generally omitted from the Findings of Fact. As Petitioner's expert testified, there is no quantitative criterion for the standard of care in prescribing opioids. (Tr., pp. 29 and 108.) The standard-of-care determination is dependent on the facts. Two facts of importance are the achievement of pain relief and the restoration or maintenance of function in the patient. The record contains ample evidence of the extent of pain relief, although nearly all of it is in the form of reports from patients, whose credibility is difficult to assess. The record contains relatively little evidence of functionality for most patients. As discussed in the Conclusions of Law, contrary to the testimony of Petitioner's expert, a standard-of-care violation is not established, per se, by a medical-records violation. The record is problematic in several other respects. Most notably: 1) Petitioner's expert witness stated in his initial report to Petitioner that Respondent's medical records were adequate and justified the course of treatment (Tr., pp. 111-22); but 2) Respondent's expert witness stated that Respondent's medical records were inadequate, at least based on present practices. (Depo. Tr., Forest S. Tennant, Jr., pp. 51- 52.) Also, in what probably came as a surprise to Petitioner, its expert witness three times opined that, under certain conditions, a physician may lawfully deviate from the applicable standard of care in the prescription of opioids. (Tr., pp. 65, 90, and 95-96.) The testimony of each expert witness was uneven. Most of the flaws of Petitioner's expert are listed above, but he repeatedly tended to agree with the attorney asking him questions. Neither expert displayed an over-familiarity with the details of the medical records; sometimes, Respondent seemed somewhat unfamiliar with them too. Petitioner's expert is Board certified in the subspecialty of pain medicine and practices in Orlando; Respondent's expert is not Board certified in any specialty or subspecialty and has never practiced in Florida. But Respondent's expert thoughtfully explained how a higher blood pressure and pulse rate might be associated with under- medication, and a lower blood pressure and pulse rate might be associated with over-medication. Respondent's expert also recognized the difference between a medical-records violation and a standard-of-care violation. During the time in question, Respondent saw 15 patients daily, not 60 or more patients daily, as are seen by some high-volume opioid-prescribing physicians. The ten patients in this case are all residents of Florida, not residents of other states drawn to the opioid-prescribing practices of a compliant Florida physician. (One of the ten patients appears to have been a resident of Mississippi, but had a Florida driver license--tending dispel an inference that he was in Florida briefly for the purpose of obtaining opioids.) Almost always, Respondent obtained patient records from the physician who had been treating the patient immediately before he or she began seeing Respondent. And, at a time when the practice was not required by statute or rule, Respondent used urine screens to determine whether his patients were consuming the opioids that he was prescribing them. For none of the ten patients has adherence to the dosing practice of a preceding physician, per se, constituted compliance with the applicable standard of care. Except for a relatively brief period after acquiring the patient, Respondent could only satisfy the applicable standard of care by appropriate treatment, regardless of the dosing practice of the preceding physician. In large part, the purpose of administering urinalyses was to detect aberrant behavior by the patient. In this context, aberrant behavior means patient diversion of opioids or consumption of other opioids or other controlled substances without disclosure to Respondent or, in the case of illegal consumption of such substances, even with disclosure to Respondent. W. C. From February 12, 2007, through July 16, 2009, Respondent prescribed to W. C. 150 30-mg roxicodone pills and 120 15-mg roxicodone pills each month. Respondent first saw W. C. on June 20, 2001, when Respondent served as the medical director of the Pain Management Center in Miami. At the time of this initial visit, according to Respondent's medical records, Respondent complained of rheumatorial arthritis of the left knee, on which he had had surgery, two years earlier, to repair a tear of the medial collateral ligament. W. C. also complained of lower back pain and tendonitis in the left elbow and shoulder. The patient's situation was exacerbated by his job, which involved moving refrigerators. The initial note states that the patient's general practitioner, Dr. Martin Coleman, had prescribed him 5-mg pills of Roxicet®, and the patient had taken some Xanax® from his wife to relieve spasms and stress. The next office visit took place on July 16, 2001, at which time Respondent brought a "note," not medical records, from Dr. Coleman. According to Respondent's medical records, Dr. Coleman's note stated that the degenerative arthritis was of the right knee, not the left knee, which had been treated with Percocet®, which is similar to Roxicet®. Evidently relying on the patient's statement that he had tried his wife's Xanax®, the July 16 record states: "His anxiety is helped tremendously with Xanax®." At this time, Respondent saw W. C. for seven or eight months. These medical records are missing, but they are not at issue in this case. At some point, W. C. transferred to the Delray office of the Pain Management Center while this office was staffed by Drs. Morency, Rabinsky, and Weed. In November 2005, W. C. suffered a wedge fracture of the T12 vertebra, which caused him severe back pain, as a result of an automobile accident. On February 14, 2007, Respondent saw W. C. in the Delray office of the Pain Management Center, to which Respondent had since transferred. Among the records that Respondent reviewed was a neurological consultation dated September 7, 2006, in which the neurologist, Dr. Perry Hoeltzell, described cervical, left arm, left lower back, and left leg complaints since the November 2005 accident. Respondent also examined an MRI of the spine taken on September 7, 2006, that showed a T12/L1 collapse of the disc with chronic anterior wedging of the T12 vertebra. The appearance was of a flexion trauma. These conditions supported the finding or complaint of cervical radiculopathy of C3 through C6 and lumbar radiculopathy of L4-5/L5-6. W. C. informed Respondent that he liked the flexibility of his current prescription of 150 pills of 30-mg roxicodone and 120 pills of 15-mg roxicodone monthly, so he could decide which dose to take when. However, W. C. did not appear to be an uncritical consumer of every controlled substance that he could get. The July 16, 2009, medical note reports that W. C. declined a renewal of Cymbalta®, saying that it did not work and, "I didn't think I needed it." At the time of the February 14, 2007, office visit and through the final office visit of July 16, 2009, W. C. was able to work and suffered no side effects. Each month, Respondent saw W. C. in the office and typically spent 15-30 minutes talking with him. The medical records over this period are inadequate and do not justify the opioid prescriptions that Respondent gave W. C. during this time. For two and one-half years, Respondent prescribed the same two prescriptions of roxicodone with medical records consisting of monthly reports of blood pressure, pulse, general appearance, patient history, and complaints, such as level of pain, the extent of pain relief, side effects, sleep, and mood. As tended to be his practice with all ten patients, Respondent never filled in the bottom of the medical-record form, which prompted insertion of the "plan." Respondent never recorded any diagnosis or general assessment of W. C., or recorded how he was managing the patient. For over two and one-half years, Respondent failed to document these important elements of medical records. This was too long for Respondent to claim that he was merely maintaining the prescription regime of the preceding physician until Respondent had the opportunity to assess the patient, discuss with the patient treatment alternatives, and develop a pain- management plan. In this timeframe, Respondent should have documented these tasks multiple times. The absence of this critical patient assessment and treatment information from the medical records means that the records fail to justify the course of treatment. Petitioner's expert witness opined that Respondent violated the applicable standard of care due to the excessive prescription of medications. But when asked why the prescribed medications were excessive, the expert responded, "the medical records," which, he explained, failed to provide an understanding of how the patient was managed, failed to provide a diagnosis, assessment, or treatment plan, and omitted any description of level of functioning, clinical exams, or physical exams. (Tr., p. 23.) Petitioner's expert witness described Respondent's medical records as "poor." (Tr., p. 27.) If there were any doubt that the basis of the expert's standard-of-care opinion was the inadequate medical records, he dispelled it in the following exchange: Q: Dr. Gerber, this prescribing of roxicodone 30 mg of 150 pills in conjunction with roxicodone 15 mg of 120 pills, what is your opinion about the appropriateness and whether or not the prescribing of those two--that combination is within the standard of care and why? A: Well, without medical records justifying it, if falls below the standard of care. There's no explanation of why these two potent opioids are being prescribed together. . . . (Tr., pp. 24-25.) Obviously, where the patients, other than W. C., do not testify, the ability of Petitioner's expert to opine as to the standard of care is limited to what he has learned of their care from the medical records and the testimony of Respondent, which supplies very little in addition to what is contained in the medical records. After an extensive discussion of the inadequacies of the medical records, in response to a standard- of-care question, the expert admitted that the lack of medical records left him "not able to formulate an opinion as to how this patient was managed." (Tr., p. 23.) Immediately after this statement, Petitioner's expert twice testified that the standard-of-care violation was due to the problems with the medical records. (Tr., pp. 23-24.) The frustration of Petitioner's expert witness, although understandable, does not justify elevating a medical-records violation to a standard-of- care violation--again, as explained in the Conclusions of Law. The sole attempt of Petitioner's expert to predicate a standard-of-care violation on something besides the inadequate medical records was unsuccessful. Although he elsewhere disclaimed reliance merely on the quantity of prescribed opioids as the sole basis of a standard-of-care violation, Petitioner's expert complained about Respondent's prescription of "these two potent opioids . . . together." (Tr., p. 25.) Of course, there is only one potent opioid at issue in the W. C. counts-- roxicodone. (Xanax®, which Respondent also prescribed to W. C., is not an opioid and, as noted above, is not alleged as a basis of any liability in this case.) If the two opioids were the two dosages of roxicodone, the expert's complaint appears to be a back-door attempt to object to the quantity of prescribed opioids--in isolation from other relevant factors. Significantly, Petitioner's expert testified that, with acceptable documentation, "one [of the roxicodone prescriptions] by [itself] might be acceptable" (Tr., p. 25)--implying that his underlying problem is with the quantity of this opioid that Respondent has prescribed. But, as Petitioner's expert witness conceded, "patients can have a lot of pain and require high doses of opioids even with minimal diagnostic studies." (Tr., p. 26.) Petitioner's expert eventually admitted that a monthly prescription of 120 pills of a hypothetical 45-mg roxicodone, which is slightly less than Respondent's prescription of 120 pills of 15-mg roxicodone and 150 pills of 30-mg roxicodone, might have met the standard of care, if "there was good documentation of physical functioning [and] the notes and records clearly documented an assessment and plan." (Tr., p. 31). For W. C., clinical reports amply documented injuries that could have accounted for the pain that W. C. consistently reported during the period in question. The record establishes sustained function during the course of treatment--and even beyond. Alone among the patients, W. C. testified to his extensive orthopedic problems in his back and to the role of Respondent and his medication regime in preserving W. C.'s functionality. Respondent's treatment of W. C. left one question unanswered. In general, Petitioner's expert rightly asked why Respondent did not offer or explore nonopioid treatments. (Tr., p. 27.) The absence of any consideration of nonopioid treatments is a deficiency in the medical records, but also relevant in determining whether Respondent met the standard of care. Respondent's usual explanation--the prohibitive costs of such alternative treatments--may not apply to W. C., who was continuously employed throughout his treatment, possibly even as the owner of the company for which he worked. Respondent testified: "He was a laborer, he had his own moving company." (Tr., p. 209.) But, standing alone, this question does not establish a standard-of-care violation. There is less, if any, value in the suggestion of Petitioner's expert that a standard-of-care violation may be based on Respondent's failure to prescribe methadone. As noted above, this record fails to establish that the standard of care requires the use of long-acting opioids for chronic pain, and this repeated suggestion by Petitioner's expert fails to account for the difficulties, noted above, in the use of this persistent opioid, which even Petitioner's expert admitted must be used "carefully." (Tr., p. 32.) Petitioner proved a medical-records violation, but not a standard-of-care violation. D. M. From January 8, 2007, through July 18, 2007, Respondent prescribed to D. M. a monthly regime of roxicodone and Oxycontin®. The sole exception to the monthly office visits with Respondent is an office visit dated February 5, 2007, which, judging from the handwriting on the note, involved another physician at the Pain Management Center. Respondent's prescriptions for January 8 and March 5 were for 100 30-mg roxicodone pills and 180 40-mg Oxycontin® pills. On April 2, Respondent increased the monthly prescription to 180 30-mg roxicodone pills while maintaining the number and dose of Oxycontin® pills. On April 30, Respondent increased the number of roxicodone pills to 200 monthly, but decreased the dosage to 15 mg, while maintaining the number and dose of Oxycontin® pills. On May 24, Respondent issued a prescription for 200 15-mg roxicodone pills, 100 30-mg roxicodone pills, and 180 40-mg Oxycontin® pills. On June 21, Respondent prescribed 200 15-mg roxicodone pills and 180 40-mg Oxycontin® pills. On July 18, Respondent prescribed 100 30-mg roxicodone pills and 180 40-mg Oxycontin® pills. D. M. is unique among the ten patients in two regards. She has the shortest treatment period at six months, and she is the only patient to have received Oxycontin® monthly for the duration of her treatment under Respondent. Another unusual aspect of D. M.'s case is Respondent's clear confusion about his treatment of her. Respondent testified that he first saw her on May 24, 2007. This testimony is contrary to the stipulation, and it is not borne out by the medical records. The medical notes for January 8 (Joint Ex. 2, p. 159), March 5 (Joint Ex. 2, p. 157), April 2 (Joint Ex. 2, p. 156), and April 30 (Joint Ex. 2, p. 155) all appear to be in the handwriting of the physician who filled out the medical note for May 24 (Joint Ex. 2, p. 346). D. M. bore a diagnosis of fibromyalgia, which is a diagnosis of a condition whose existence divides the medical community. However, associated with the diagnosis is widespread pain involving the muscles and soft tissues and sleep disturbances, both of which D. M. reported. Although the disease is not like a fracture or herniated disc in its ability to be confirmed by some form of imaging technology, the present record provides an inadequate basis to disregard the existence of this condition or dismiss the potential severity of the pain associated with this condition. In 1995, D. M.'s physician, Thomas Fitzpatrick, M.D., referred D. M. to John H. Gridley, Jr., M.D., who specialized in internal medicine and rheumatology. After an examination of this 35-year-old patient, Dr. Gridley diagnosed D. M. with what is now referred to as fibromyalgia. She has borne this diagnosis ever since. D. M. had been a patient of the Kendall office of the Pain Management Center since 2003. Her condition had deteriorated since 1995; she had spent two years in bed. During this time, she had received the opioids that Respondent later maintained. When D. M. first saw Respondent nearly 12 years later, she had gained 70 pounds, and her systolic blood pressure had increased 34 mm to 144/72. D. M. advised Respondent that the only medication that relieved her pain was Oxycontin®, so, after discussing diet and exercise, Respondent continued her existing prescription of Oxycontin® with roxicodone for breakthrough pain. On D. M.'s next visit, on March 5, no vital signs were taken. On her next visit, on April 2, her blood pressure had dropped to 102/78, although her pulse was 78. Her pain, which was reported as "6" on her first visit, was down to "5" on this visit. In addition to his confusion over when he started treating D. M., Respondent seemed confused by his own treatment plan for this patient. Alluding to his much-used explanation of financial constraints precluding the prescription of Oxycontin®, Respondent testified that, due to "financial reasons," "we converted one Oxycontin® to Roxy 30s, giving her exactly the same dosage. The patient was having financial problems. I remember that." (Tr., p. 227.) However, the record reveals no reduction in the relatively expensive Oxycontin® prescription, only an increase in the roxicodone prescription on April 30 and again on May 24. Later, Respondent testified that his office mistakenly increased the roxicodone prescription on April 30 from "100 to 180 milligrams." (Tr., p. 228.) However, this increase amounted to only 20 30-mg pills for the month or about 20 mg daily. The increase on May 24 was much larger--from 6000 mg/month of roxicodone to 9000 mg/month of roxicodone. This was also a mistake, but a much bigger one. D. M. never informed Respondent of the prescription error, which Respondent "didn't like." (Tr., p. 228.) Respondent reduced the June 21 prescription, probably to allow D. M. to use some of the extra roxicodone that she had on hand. (Tr., p. 228.) However, Respondent never attempted to explain how these two dosing mistakes happened or, if they were not mistakes, what justified these dramatic increases in opioids being prescribed to the patient. Respondent probably did not attempt a justification of these increased dosages because no justification existed: D. M. reported a small increase in pain from April 30 to May 24, but only from a "5" to a "6." Consistent with his refusal to predicate a standard- of-care violation strictly on the quantity of opioids prescribed, Petitioner's expert witness admitted, "counting pills is not the best way of managing a patient." (Tr., p. 43.) But his standard-of-care analysis regarding Respondent's care for D. M. includes the quantity of pills in the context of patient complaints, the underlying diagnosis, and the existence of alternative means of treating the patient's pain, such as a fentanyl patch. (Tr., pp. 40 and 45.) The standard-of-care violation for D. M. relies on this broader record of Respondent's care for this patient, not on the following testimony of Petitioner's expert: "So, the whole case boils down to, you shouldn't be putting patients with fibromyalgia on this much medication." (Tr., p. 44.) Neither in May 2007 nor three and one-half years later at the hearing did Respondent have any idea why he dramatically increased D. M.'s roxicodone prescription on May 24. To the extent that Respondent claimed a "mere" mistake, his explanation would have carried more weight, if he had not also offered his well-worn financial argument that the patient could not afford the additional cost of the long-acting opioid, Oxycontin®. This argument did not apply to D. M., who was already paying for Oxycontin® each month. This makeshift defense, the unjustified increase of opioids, the mistaken recollection of the substitution of roxicodone for Oxycontin®, and the failure to recall when Respondent's treatment of this patient started combine to make Respondent's brief treatment of D. M. appear random and chaotic. On these facts, Respondent's prescription of opioids was inappropriate, excessive, and otherwise unjustified. Petitioner proved a medical-records violation and a standard-of-care violation. R. H. From January 29, 2007, through July 7, 2009, Respondent prescribed to R. H. a monthly regime of 30-mg roxicodone and 10/235 Norco®. For January 29 and March 2, the dosages were 60 roxicodone pills and 240 Norco® pills. On March 27, Respondent raised the roxicodone prescription to 90 pills. This prescription continued through visits on April 24, May 22, June 20, and July 18. On August 2, which was only two weeks after the preceding office visit, Respondent doubled the number of roxicodone pills to 180. On September 28, Respondent increased the roxicodone by one-third, from 180 to 240 pills. On November 30, Respondent increased the roxicodone prescription to 300 roxicodone pills and, for the first time, changed the Norco® prescription, raising it from 240 pills to 300 pills. Respondent maintained these prescriptions through 14 "monthly" visits in 2008--actually, 13, as the last is on December 23, 2008--and visits on January 21 and February 17, 2009. On March 17, Respondent decreased the Norco® to 280 pills. On the final visit, on July 7, 2009, Respondent decreased the roxicodone to 270 pills and Norco® to 240 pills. Respondent first saw R. H. in 2001 due to failed-back syndrome following a car accident three or four years earlier and a micro-discectomy of L5/S1, which had resulted in additional complications. R. H. had been wheelchair-bound for eight months and was learning to walk again; she was in intractable pain. A psychiatrist later diagnosed her with severe anxiety disorder and post-traumatic stress disorder. R. H. visited the Pain Management Center after a referral by her physician, who was no longer comfortable prescribing her Vicodin ES®. R. H. disclosed in her 2001 initial office visit that she had recently had another automobile accident, for which she had been charged for driving under the influence. R. H. reported that epidural injections had failed to control her pain, and she had gained 50 pounds in the past couple of years. An unsettling consultation note is in R. H.'s medical records. On January 31, 2001, Anjan K. Ghosh, M.D., of the Anesthesia Pain Care Consultants, Inc., saw R. H. in consultation. Dr. Ghosh concluded the R. H. suffered from lumbar post-laminectomy pain syndrome "with conflicting physical signs on examination," mechanical lumbar axial pain, severe anxiety disorder, and gastroesophagael reflux disease. In a detailed plan of treatment, Dr. Ghosh proposed a caudal catheter neuroplasty and nerve root decompression to treat R. H.'s recurrent lumbar radiculitis. Based evidently in part on an adverse surgical experience, R. H. refused this treatment, saying, "the reason I was sent to see you [was] for only pain medication." After Dr. Ghosh explained that he would continue her Vicodin ES® only for two weeks, R. H. asked again if she could consider the surgical intervention later, but, for now, obtain prescriptions for an opioid regimen, which Dr. Ghosh declined to do. R. H. was an unusual patient because, even though she was in her mid-thirties when she first saw Respondent, she often brought her mother, who, according to Respondent, "doled" out her prescribed opioids. (Tr., p. 242.) In contradictory statements, Respondent testified: "She did well. She was able to function. She lost jobs constantly." (Tr., p. 243.) Respondent's testimony about this patient is surprisingly brief based on the lengthy two and one-half years that he saw her, as covered by this case; the dramatic increase in roxicodone from 1800 mg monthly to 9000 mg monthly, with a smaller increase in Norco®; and the instability of the patient, as reflected by her dogged pursuit of opioids, her DUI arrest five or six years earlier, and the role of her mother as the gatekeeper to her prescribed opioids. Petitioner's expert witness noted that the March 27, 2007, medical note, in which Respondent raised the roxicodone from 60 pills to 90 pills monthly, contained no explanation for the increase. Likewise, Petitioner's expert found no justification in the medical records for the doubling of the roxicodone from 90 pills to 180 pills monthly in August 2007, the increase from 180 pills to 240 pills monthly two months later, or the increase of the Norco® from 240 pills to 300 pills monthly one month later. Petitioner's expert noted these increases in opioids were not accompanied by physical exams, physical findings, or any consideration of alternative therapies, such as nonsteroidal anti-inflammatory drugs. Respondent's medical records reveal a "4" for reported pain on March 1, 2007, but no vitals, and no pain report or vitals on March 27, 2007, when Respondent hiked the roxicodone by 50% and prescribed Neurontin®, which Respondent testified at the hearing he did not "even know what it is." (Tr., p. 240- 41.) The medical note for April 24, 2007, consists of a few scribbled lines without any vitals or pain report. On May 22 and June 20, 2007, the medical records contain vitals, but no pain report. Finally, on July 18, the medical note contains a pain report, but it is still a "4." Two weeks later, when Respondent doubled the roxicodone from 90 to 180 pills monthly, the medical note reflects that the pain is still only a "4." During this period of time, R. H. had had a molar surgically removed on April 7, 2007, and had been passing out weekly since that event. In mid-September 2007, R. H. was admitted to a local hospital one week after an automobile accident. In the followup to the automobile accident, a CT scan of the brain revealed vascular abnormality, which required a followup hospital admission that did not reveal anything especially serious. However, the accident had resulted in some upper extremity pain and some back pain. At the time of the hospital admission in connection with this accident, R. H. admitted only to the use of Soma® and Valium®, as well as occasional marijuana, but not the extensive opioids that Respondent was prescribing. All of this information is in Respondent's medical records. R. H. reported a pain level of "8" on the September 28 medical note, despite the large increase in roxicodone prescribed two months earlier. If there was a discussion of the recent automobile accident, it does not emerge from the nearly illegible notes, and Respondent did not testify to any analysis of the effect of this recent accident. At this time, Respondent increased the roxicodone by 50%--from 180 pills to 240 pills monthly. On November 1, 2007, the medical note reveals that R. H. reported pain at a level of "5." On a patient questionnaire, R. H. reported that pain had not interfered at all in the past month with her mood, walking, sleeping, concentrating, appetite, work, or relationships, and she denied any side effects. Despite this information, one month later, on November 30, with the pain reported at only a "4," Respondent increased the roxicodone by 60 pills monthly. While Respondent maintained this prescription through 2008, R. H. reported pain at only a "4." On February 17, 2009, in a medical review, Respondent noted that R. H.'s urine had tested positive for THC. This note records R. H.'s difficulty in keeping a job. This note describes a treatment plan to continue the present pain medications, possibly taper benzodiazepines, and continue to refer R. H. to psychotherapy. There is little connection between the medical records--most notably, the self-reported pain levels--and the amount of opioids that Respondent prescribed. Given the obvious difficulties that this patient was experiencing and the large increases in opioids that Respondent prescribed her, the treatment plan described in the preceding paragraph was insufficient. These facts do not depict merely a failure of the medical records to justify the course of treatment. Even without regard to the single indication of marijuana use, R. H. was a substance abuser who lied to health-care providers about what she was taking and required her mother to control her access to the opioids that Respondent prescribed. Respondent's treatment "plan" was to give R. H. exactly what she wanted, including one drug with which Respondent was completely unfamiliar. This patient needed help, and Respondent, for two and one-half years, failed to practice in accordance with the applicable standard of care by continuing to supply her with an increasing supply of opioids--essentially, failing to treat her. Under these circumstances, Respondent's opioid prescriptions were inappropriate, excessive, and otherwise unjustified. Petitioner proved a medical-records violation and a standard-of-care violation. K. L. From March 15, 2007, through July 16, 2009, Respondent prescribed to K. L. a monthly regime of mostly 30-mg roxicodone with occasional 10/325 Percocet®, 80-mg Oxycontin®, and 15-mg roxicodone. On March 15, 2007, Respondent prescribed 420 30-mg roxicodone pills (all roxicodone prescriptions for K. L. are for 30 mg unless otherwise stated) and 120 Percocet® pills. This prescription continued through office visits on April 11, May 9, and June 6, at which time Respondent dropped the Percocet® prescription. From July 2, 2007, through November 14, 2007, which covers five and one-half months, Respondent prescribed "monthly"--on six occasions--420 pills of roxicodone. On December 12, 2007, Respondent reduced the prescription to 400 pills of roxicodone, but added 60 Percocet® pills. This prescription continued through office visits on January 8, 2008, and February 7. On March 5, 2008, Respondent dropped the Percocet® from the prescription, but raised the roxicodone to 420 pills. This prescription continued until January 5, 2009--so as to cover 11 months with 12 "monthly" prescriptions. On January 30, 2009, Respondent reduced the roxicodone from 420 pills to 360 pills. On February 26, 2009, Respondent effectively increased the prescription by reducing the 30-mg roxicodone from 360 pills to 280 pills, but adding 200 pills of 15-mg roxicodone. On March 5 and 6, 2009, Respondent prescribed 90 roxicodone pills, 30 Percocet® pills, and 26 Oxycontin® pills (in two prescriptions). Four days later, on March 10, Respondent prescribed 120 roxicodone pills. Fifteen days later, on March 26, Respondent prescribed 390 roxicodone pills. On April 22, Respondent prescribed 360 roxicodone pills. On May 20, he prescribed 330 roxicodone pills. And on June 17 and July 16, 2009, Respondent prescribed 300 roxicodone pills each office visit. At the initial visit, K. L. informed Respondent that he had been seeing another pain physician, Frederick Swartz, M.D., but was required to visit every three weeks and found the office hours inconvenient. One may safely infer that the frequency of visits was part of Dr. Swartz's attempt to restrict K. L.'s aberrant behavior. Dr. Swartz had prescribed, every three weeks, 84 Percocet®, 284 roxicodone, and 84 Xanax®. On a monthly basis, the 84 pills translate to about 121 pills, and the 284 pills translate to about 410 pills. Respondent's initial prescription thus maintained the levels of Percocet® and roxicodone that the preceding physician had prescribed. During the initial interview, K. L. advised Respondent that he had suffered orthopedic injuries from being struck in the face with a baseball bat many years earlier, as well as two automobile accidents more recently. Having previously worked as a personal trainer, according to the notes, K. L. "works now in the New York State Business." The meaning of this statement remains known only to its author, but does not necessarily mean that K. L. was an out-of-state patient. K. L. informed Respondent that he obtained adequate pain relief from the 14 roxicodone that he took daily. K. L. stated that he had tried Oxycontin® for a couple of days, but did not like it due to cognitive impairment. His only surgical history involved the repair of the eye socket following the baseball bat injury. K. L. rated his pain as a "6." Respondent testified that, after four months, he eliminated the Percocet® because there was no need for K. L. to be taking two short-acting opioids simultaneously, and Respondent was concerned about potential acetaminophen toxicity. These were prudent concerns. A major issue in this patient's treatment developed when, on March 15, 2007, he took a urinalysis, and it tested positive for opiates, in addition to the oxycodone and benzodiazepine that Respondent had been taking, as prescribed. The test results distinguish between the oxycodone present in the roxicodone and Percocet® that had been prescribed for K. L., and other, nonprescribed opiates, such as heroin and codeine. K. L. failed subsequent urinalyses administered by Respondent. On May 9, 2007, his urine tested positive for oxycodone and other opiates, but not benzodiazepines. On February 7, 2008, January 30, 2009, and February 26, 2009, K. L.'s urine tested positive for oxycodone, morphine (another opiate that evidently is disclosed separately from opiates), and benzodiazepines. Respondent's contradictory testimony confirms his mishandling of the patient. Initially, Respondent testified that he had concluded, when K. L.'s urinalyses first disclosed opiates, that K. L. suffered from some sort of rare condition in which the liver failed to metabolize the oxycodone and caused the urinalyses to detect the oxycodone as other opiates. This explanation is discredited because Respondent failed to order additional lab work on liver function at the time and failed generally to proceed to rule out or otherwise deal with any liver problems. Respondent later admitted, in cross- examination, that he was not concerned about K. L.'s liver in 2007 (Tr., p. 339.), but only became concerned about it in 2009. (Tr., p. 340.) The actual explanation for the failed urinalyses was K. L.'s consumption of other opiates that he was not disclosing to Respondent. And Respondent was aware of this aberrant behavior. Undermining his testimony about a later suspicion of liver dysfunction, Respondent, reading from a medical note dated January 30, 2009, testified: "I even put [K. L.] on probation because I thought he was lying to me." Obviously, he would not have put a patient on probation for impaired liver function. Even if Respondent were telling the truth that he did not realize, until January 30, 2009, that K. L. had been lying to him about other opiate use--which he was not--two facts nonetheless undermine Respondent's attempted explanations. First, from March 15, 2007, through January 30, 2009, Respondent prescribed to K. L. over 10,000 roxicodone pills. After Respondent claimed to have concluded that K. L. was lying about other opiate use, Respondent prescribed, from February 26, 2009, through July 16, 2009, over 2000 more roxicodone pills plus 200 15-mg roxicodone pills. As was the case with R. H., these facts do not depict merely a failure of the medical records to justify the course of treatment. K. L. is also a substance abuser, engaging in the especially dangerous behavior of combining his prescribed opioids with unprescribed opioids. For almost two years, Respondent joined K. L. in an elaborate rationalization process designed to avoid confronting the patient's urgent problem. K. L. needed help, and Respondent, for two years, failed to practice in accordance with the applicable standard of care by continuing to supply him with an increasing supply of opioids-- essentially, failing to treat him. Under these circumstances, Respondent's opioid prescriptions were inappropriate, excessive, and otherwise unjustified. Petitioner proved a medical-records violation and a standard-of-care violation. J. K. From May 22, 2007, through July 27, 2009, Respondent prescribed to J. K. a monthly regime of 30-mg roxicodone plus Oxyfast® occasionally. (All roxicodone prescriptions for J. K. are for 30 mg.) On May 22, 2007, Respondent provided J. K. with two prescriptions of 120 roxicodone pills each. On June 19, Respondent wrote J. K. two roxicodone prescriptions--one for 150 pills and one for 170 pills. On July 16, Respondent wrote J. K. a prescription for 150 roxicodone pills, a prescription for 120 roxicodone pills, and one bottle of Oxyfast®. On August 13, Respondent wrote J. K. a prescription for 300 roxicodone pills, five roxicodone pills, and two bottles of Oxyfast®. On September 10, Respondent wrote J. K. a prescriptions for 295 roxicodone pills, five roxicodone pills, and one bottle of Oxyfast®. On October 8, Respondent reduced the numbers of roxicodone pills by giving J. K. prescriptions for 190 roxicodone pills, 140 roxicodone pills, ten roxicodone pills, and one bottle of Oxyfast®. On November 2, Respondent maintained these prescriptions, dropping only the prescription for ten roxicodone pills. But, three days later, Respondent gave J. K. a prescription for ten roxicodone pills. On December 3, 2007, Respondent greatly increased the prescription, raising it to 410 roxicodone pills and two bottles of Oxyfast®. On January 4, 2008, Respondent reduced the prescription to 330 roxicodone pills in one prescription and ten roxicodone pills in the other, as well as two bottles of Oxyfast®. Again, on February 1, 2008, Respondent increased the prescription, raising it to 380 roxicodone pills, but dropping the Oxyfast®. Respondent repeated this prescription on February 28 and raised it to 410 roxicodone pills on March 28. Respondent lowered it to 380 roxicodone pills on May 22. Then, on May 22, June 19, July 17, and August 13, Respondent prescribed 450 roxicodone pills each month. Respondent did not see J. K. for the next five months. On January 19, 2009, Respondent gave J. K. separate prescriptions of 200 and 250 roxicodone pills. On February 13, Respondent issued J. K. a single prescription for 450 roxicodone pills. On March 12, Respondent issued five roxicodone prescriptions for 200 pills, 100 pills, 100 pills, 50 pills, and 70 pills--for a total of 520 pills. Six days later, on March 18, Respondent gave J. K. another roxicodone prescription--this time for 30 pills. On April 7, Respondent gave J. K. two roxicodone prescriptions--one for 100 pills and one for 250 pills. Six days later, on April 13, Respondent gave J. K. two more roxicodone prescriptions--one for 200 pills and one for 50 pills. On May 5, Respondent gave J. K. a roxicodone prescription for 250 pills. On June 1, Respondent gave J. K. roxicodone prescriptions for 250 and 200 pills each. And on June 29 and July 27, Respondent gave J. K. roxicodone prescriptions for 450 pills each. J. K. had been a semi-professional hockey player who retired prematurely due to back pain. He exacerbated his back problems when he was involved in an automobile accident on April 19, 2004. On July 16, 2007, J. K. reported a pain level of "7," but this increased to a "9" on August 13, 2007. At this time, Respondent increased the roxicodone prescription. However, the medical records do not reveal escalating pain reports during the first half of 2008 when Respondent twice ramped up the roxicodone levels. The complaints of Petitioner's expert witness are that Respondent prescribed short-acting opioids for chronic pain, and Respondent prescribed excessive opioids for the injury at issue, which Petitioner's expert first identified as the older hockey injury, not the newer injury from the car wreck. These complaints appear ungrounded. As noted above, this record fails to reveal the superiority of long-acting opioids over short-acting opioids for the treatment of chronic pain, and Petitioner's expert acknowledged that a practitioner must sometimes prescribe roxicodone, rather than a long-acting opioid, such as Oxycontin®, due to cost considerations. Obviously, in suggesting that J. K.'s pain was disproportionate to his injury, Petitioner's expert would have enjoyed greater credibility if he had not first based his testimony on the much- older hockey injury to the face, rather than the newer injuries to the back from the automobile accident. In her cross-examination of Respondent, Petitioner's counsel tried to suggest that Respondent violated the standard of care by resuming the roxicodone prescription, after a five- month hiatus in visits between August 2008 and January 2009. However, Respondent first confirmed that J. K. was positive for oxycodone and, thus, not opioid-naïve. Respondent also explained that J. K. had seen a doctor in New Jersey while he was there visiting his mother. Essentially, for J. K., the standard-of-care opinion of Petitioner's expert witness is based entirely on inadequate medical records. The expert noted correctly that Respondent's medical records, which span two years, lack assessments, diagnoses, and treatment plans. At times, the medical records fail to support changes in medications. But Petitioner has failed to prove that Respondent's treatment of J. K. itself violates the standard of care because there is some correspondence between pain reports and prescription quantities. Petitioner proved a medical-records violation, but not a standard-of-care violation. K. G. From June 19, 2007, through July 27, 2009, Respondent prescribed to K. G. a monthly regime of 30-mg roxicodone pills. (All roxicodone prescriptions to K. G. are for 30-mg doses, unless otherwise indicated.) For the first four months, Respondent prescribed 300 roxicodone pills monthly. For the next four months, Respondent prescribed 280 pills monthly. For the next year, Respondent did not see K. G. When K. G. returned on December 19, 2008, Respondent prescribed 280 roxicodone pills, which he maintained for the next two months' prescriptions. On April 6, 2009, Respondent maintained the prescription at 160 30-mg roxicodone pills plus 240 15-mg roxicodone pills, which is the equivalent of 280 30-mg pills. On April 30, 2009, Respondent provided two prescriptions of 160 and 120 roxicodone pills, and, on May 26, June 24, and July 27, 2009, Respondent prescribed 280 roxicodone pills each month. K. G. presented to Respondent with complaints of lower back pain, probably resulting from two automobile accidents. An MRI of the lumbar spine showed a herniated disc at L5/S1, causing impingement of the right and left S1 nerve root, and a herniated disc at L4/L5. Dr. Deluca, who was no longer practicing, had been prescribing K. G. 120 80-mg Oxycontin® pills and 420 30-mg Oxycontin® pills, presumably monthly. K. G. had been switched to Suboxone®, which is used to withdraw a patient from opioids, but K. G. admitted to buying and using Oxycontin® on the street. The initial note contains a treatment plan. Claiming a pain level of "9," K. G. asked to resume Oxycontin®, but Respondent declined, based in part of K. G.'s history of high intake of opiates. Respondent instead suggested interventional pain management. A urinalysis administered on the initial visit was negative as to "everything." Respondent then prescribed ten roxicodone pills daily, perhaps revealing a belief that K. G. was not, in fact, opioid-naïve at the time. On K. G.'s next visit, on July 17, 2007, he tested positive for THC. In a medical note dated October 22, 2007, Respondent noted that K. G. had not seen the orthopedist, to whom he had referred him. Respondent found K. G. difficult to manage because he traveled a lot, working as a market maker for stocks. K. G. took Suboxone®, but only to avoid withdrawal symptoms from interruptions in his roxicodone regime while he was in other countries, where he presumably could not take his roxicodone. On January 4, 2008, Respondent placed K. G. on probation due to unspecified aberrations in behavior. K. G. promptly discontinued seeing Respondent for over ten months between January 4 and November 21, 2008. On his return, K. G. again tested positive for THC. Respondent testified that he counseled him not to continue to use marijuana, but his records do not document this fact. Respondent continued treating K. G. for another eight months without administering another urinalysis. Again, the medical records reveal no assessment, diagnosis, or treatment plan. Petitioner's expert witness pursued some false trails in trying to establish a standard-of-care violation. He complained about a split prescription on April 30, 2009, but there were only three such prescriptions over two years, and this record fails to reveal a sinister purpose in splitting prescriptions. About the worst thing that Petitioner's expert has to say about the practice is that he is "not sure of the purpose for that." (Tr., p. 70.) Petitioner's expert witness raised the issue of short-acting versus long-acting opioids, but this has already been addressed. Petitioner's expert objected to Respondent's prescription of Xanax® and Soma®, but, as already noted, Petitioner did not plead these matters. Petitioner's expert witness mentioned the polysubstance use of benzodiazepines and oxycodone--both prescribed--with marijuana. Petitioner's expert opined that patients who persist in using marijuana "need to be tapered off their [opioids] and referred for [substance abuse] counseling." (Tr., pp. 72 and 145.) Respondent's expert opined that practitioners are divided in what to do with patients whose aberrant behavior involves exclusively marijuana use. The standard of care as applied to marijuana use is discussed in the Conclusions of Law. Petitioner's expert finds firmer footing when he ties in the other aberrant behavior of K. G., including obtaining Oxycontin® on the street and K. G.'s on-again, off-again misuse of Suboxone® as a opiate-substitute, not as an agent to assist in opiate detoxification. When K. G. ignored Respondent's referral to an orthopedist, K. G. blatantly ignored Respondent's lone attempt to initiate a reexamination of the patient's underlying condition. There were one or more unspecified aberrant behaviors, and, when Respondent finally placed the patient on probation, K. G. quit seeing Respondent for ten months: on his return, he promptly tested positive for marijuana again. These facts are the grounds of the standard-of-care violation. As was the case with R. H. and K. L., so it is with K. G. By continuing to prescribe opioids and not treating the underlying condition, or tapering him off and then dismissing K. G. as a patient, if he refused to stop his aberrant behavior, Respondent essentially deprived K. G. of the treatment that he required. Petitioner proved a medical-records violation and standard-of-care violation. D. D. From June 30, 2008, through June 3, 2009, Respondent prescribed to D. D. a monthly regime of 290 30-mg roxicodone pills. And, in this case, a one-year span produced only 12 prescriptions. At his initial visit on June 30 or July 1, 2008, D. D., a diabetic in his 50s, presented with pain in both knees. His left knee had been replaced two years earlier and was doing well, but he was awaiting replacement of his right knee. D. D. had an abscess at L5/S1. He was on SSI disability. Although taking 30-mg and 15-mg roxicodone, D. D. wanted to get off the 30-mg pills because he had no insurance. Obese at 192 pounds, D. D. reported his pain to be an "8." The treatment plan involved converting D. D.'s 15-mg roxicodone pills for 30-mg roxicodone pills, despite his interest in dropping the 30-mg pills, but Respondent maintained the same dosage as had been prescribed by the preceding physician. Otherwise, the treatment plan consisted of discussing the rules of the Pain Management Center. Petitioner's expert witness complimented Respondent on his initial medical record: he called it a "well presented medical record, a good history there. I think this is an appropriate medical record." (Tr., p. 85.) And it is. Petitioner's expert also testified that the patient required opiate management. Laboring under a misunderstanding as to the amount of roxicodone that Respondent had prescribed on the first visit, Petitioner's expert was alarmed by what he thought had been a doubling on the second visit; in fact, the quantity had remained unchanged. In this case, given the short time of treatment and the extensive medical difficulties of the patient, whom Respondent described aptly as "one of the saddest patients I have" (Tr., p. 230), Petitioner's expert lacked support in the record for his opinion that Respondent was required to address eliminating pain medications from D. D.'s life. D. D. was a low-functioning person when he presented to Respondent, and the standard of care did not require, within one year, that Respondent either get D. D. off opioids or substantially improve his function. However, toward the end of the treatment period, D. D. enjoyed greater functionality, as he was able to help raise his grandson. Petitioner failed to prove a medical-records violation or a standard-of-care violation. J. M. From October 1, 2007, through July 3, 2009, Respondent prescribed J. M. a monthly regime of 30-mg roxicodone pills and Oxyfast bottles. (All roxicodone prescriptions to J. M. are for 30-mg doses, unless otherwise indicated.) On October 1, 2007, Respondent prescribed 240 roxicodone pills and one bottle of Oxyfast.® On October 23, Respondent maintained the roxicodone, but doubled the Oxyfast® to two bottles. Respondent maintained this prescription level the next month. On December 21, Respondent essentially maintained the same prescription level by prescribing 105 30-mg roxicodone pills and 273 15-mg roxicodone pills, as well as two bottles of Oxyfast.® On January 18, 2008, Respondent again maintained the same prescription level by prescribing 70 30-gm roxicodone pills and 340 15-mg roxicodone pills, plus two bottles of Oxyfast.® But four days later, Respondent prescribed another 70 roxicodone pills. On February 18, Respondent prescribed 240 roxicodone pills in two prescriptions--one for 70 pills and one for 170 pills--but no Oxyfast.® On March 25, Respondent prescribed 240 roxicodone pills--in separate prescriptions of 110 and 130 pills--and two bottles of Oxyfast®. Respondent repeated this prescription, but with a single roxicodone prescription each month, for the next nine months. The only exceptions were split prescriptions of 140 pills each on June 17 and the discontinuation of visits between June 17 and September 8. On February 24, 2009, Respondent reduced the prescription to 60 pills of 15-mg roxicodone. On March 23, he raised it to 300 pills of roxicodone--split into prescriptions of 120 pills and 180 pills--and two bottles of Oxyfast.® On April 17, Respondent prescribed two bottles of Oxyfast®, and, on April 23, Respondent prescribed 70 roxicodone pills. On May 15 and June 10, 2009, Respondent prescribed 300 roxicodone pills--divided into two prescriptions of equal amounts--and two bottles of Oxyfast®. On July 3, 2009, Respondent prescribed 300 roxicodone pills--divided into prescriptions of 80 and 220 pills--and two bottles of Oxyfast®. In the initial visit in 2002, J. M. presented as a 32-year-old male with lower back pain. He reported that he had injured his back a few months earlier picking up an object. Unable to lift, J. M. had had to quit working as a gardener. He had been taking four or five Percocet 10/325's daily. The treatment plan, which was prepared by Respondent, was to help J. M. quit smoking tobacco and convert him from Percocet, with the potential acetaminophen toxicity, to roxicodone. J. M. told Respondent that his girlfriend had let him try some of her Xanax®, which had helped him with spasms and sleeping, so Respondent prescribed that too. They also discussed that J. M. should exercise his COBRA rights on his insurance because he was going to get some evaluations, as well as epidural injections. An MRI of the lumbar spine performed on February 6, 2008, revealed multilevel central disc herniations at L2/L3, L3/L4, L4/L5, and L5/S1 with annular tears in the herniations at L3/L4, L4/L5, and L5/S1. The MRI disclosed mild spinal stenosis at L4/L5. None of the ten patients involved in this case displayed the same extent of objective bases for the pain of which he or she complained. In August 2007, while being seen by Dr. Morency at the Pain Management Center, J. M. expressed a desire to be seen by a different physician, but the medical record fails to reveal why. On October 1, 2007, when first treating J. M., Respondent continued the level of opioids that Dr. Morency had been prescribing. Respondent prescribed Oxyfast® with roxicodone because the former, as a liquid, has a faster onset than the pill, which can take 45 minutes to take effect. Respondent testified that he doubled the Oxyfast® on October 23 because the pain was worse. But, according to the medical records, J. M. reported pain of "5" on October 1, 2007, and, three weeks later, reported pain of only "3." On July 3, 2009, a urinalysis revealed THC. Respondent discussed with J. M. his aberrant behavior and placed him on probation, warning him not to test positive for marijuana again. However, J. M. had tested positive for marijuana on April 17, 2006, August 7, 2007, and October 23, 2007--each time he had been tested. Respondent did not test J. M. again for nearly two years. Petitioner's expert faulted Respondent for his handling, or lack of handling, of J. M.'s apparently ongoing marijuana use during treatment. This is addressed in the Conclusions of Law. Petitioner's expert witness faulted Respondent for using short-acting opioids rather than long-acting opioids, but this has been dealt with already. Except for the doubling of the Oxyfast® early in the period of treatment, the medical records fail to establish a correspondence between pain reports and prescription levels of roxicodone on three occasions: the two months during which Respondent supplemented the roxicodone prescription with 70 pills and the 25% increase in roxicodone in early 2009. The medical records lack assessments, diagnoses, and treatment plans. In particular, the medical records are deficient because they do not justify the three increases in prescribed opioids. But there is insufficient evidence of a standard-of- care violation as to J. M. There is insufficient evidence of aberrant behavior that would require Respondent to taper off J. M. from pain medications--despite well-documented sources of pain--while he obtained counseling to help him stop using marijuana. And the three instances in which increased prescriptions were not justified in the medical records prove a medical-records violation, not a standard-of-care violation, as discussed in the Conclusions of Law. No other evidence in the record establishes a lack of justification for the prescribed opioids. Petitioner proved a medical-records violation, but not a standard-of-care violation. M. L. From April 26, 2007, through March 3, 2009, Respondent prescribed to M. L. a monthly regime of 30-mg roxicodone pills, except for a single prescription of oxycodone and two prescriptions of Percocet® 10/325. (All roxicodone prescriptions to M. L. are for 30-mg doses.) On April 26, 2007, Respondent prescribed 440 mg of roxicodone pills in two prescriptions--one for 200 pills and one for 240 pills. Respondent repeated this prescription monthly for seven months--eight times--when, on December 6, 2007, he raised it to 540 mg in two prescriptions--one for 290 pills and one for 250 pills. Starting January 8, 2008, Respondent returned to his initial pattern of prescribing 440 pills of roxicodone in two prescriptions. This continued through 2008--again, counting January 8, this amounted to 13 prescriptions, not 12, over the year. Respondent continued this prescription pattern on January 6 and February 2--the latter incorporating 40 15-mg roxicodone pills to achieve the same total prescription in dosage. On March 3, 2009, Respondent prescribed 150 roxicodone pills, 210 5-mg oxycodone pills, and 210 Percocet® 10/325 pills. In 1999, David Buchalter, M.D., referred M. L. to the Pain Management Center with a report stating that an MRI suggested that the patient had a small herniated disc at C3/C4, a mild disc bulge at C4/C5, and degenerative disc space narrowing at C5/C6. By the time that Respondent saw M. L., he had been complaining of neck and lower back pain for many years. M. L. could not afford Oxycontin®, but a urinalysis confirmed that he was taking his prescribed short-acting opioids. M. L. had been seen by the Pain Management Center for several years, and he had never exhibited aberrant behavior. Nothing stands out in the record concerning the care received by M. L., although, again, two years of medical records contain no assessment, diagnosis, or treatment plan. Petitioner proved a medical-records violation, but not a standard-of-care violation. M. P. From February 12, 2007, through July 7, 2009, Respondent prescribed to M. P. a monthly regime of Oxycontin and methadone initially and, later, mostly roxicodone. (All roxicodone prescriptions for M. P. are for 30 mg, unless otherwise indicated.) M. P. had been seen by the Pain Management Center since at least 2002. He was operating a forklift in 1999 when boxes fell on him, injuring his neck. An MRI revealed a ruptured disk at C3/C4, a disc bulge at C4/C5, and degenerative disc disease at C5/C6. At the time of the office visit, M. P. was still employed driving a forklift, but was taking 120 mg of Oxycontin® daily. Despite a medical record dated January 5, 2006, stating that M. P. could not afford Oxycontin®, he was still on this relatively expensive, long-acting opioid at the start of the period in question. During his years of treatment at the Pain Management Center, M. P. had never displayed any aberrant behavior, as periodic urinalyses revealed that M. P. was taking his prescribed opioids and nothing else. The medical records during the period in question contain no patient assessments or treatment plans, nor do they explain the switching of medications. Of particular interest, as to the standard of care, is the relatively long period that Respondent prescribed two long-acting opioids, methadone and Oxycontin®. As Petitioner's expert testified, such overlapping is appropriate during a dosage-transition phase, as the practitioner transitions the patient from one such opioid to another. But here, Respondent prescribed methadone and Oxycontin for five months. At the end of this period, Respondent discontinued the Oxycontin®, but there is no constant tapering off of Oxycontin® during this period. From February to July 2007, the monthly prescriptions for Oxycontin® are for 14,400 mg, 14,400 mg, 14,400 mg, 14,400 mg, 0 mg, and 4800 mg. As noted above, methadone is difficult to use for analgesic purposes. Doubtlessly, this difficulty is increased by adding another long-acting opioid, even if its half life is much shorter than the half-life of methadone. But this is really all that Petitioner presents for a standard-of-care violation. Although it is a close question, Petitioner's evidence fails to convince that five months' dual prescribing of two long-acting opioids was inappropriate, excessive, or unjustified. Petitioner's expert questioned the amount of roxicodone prescribed, in conjunction with methadone, for back pain. This criticism was less well-founded, as Respondent eventually discontinued the methadone also. Additionally, M. P. tended to report high pain levels during the period in question. Again, during the two and one-half years of relevant treatment, the medical records fail to include an assessment, diagnosis, or treatment plan, including any guide to the transitioning of the patient off of two long-acting opioids. Petitioner proved a medical-records violation, but not a standard-of-care violation.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of nine counts of medical-records violations and four counts of standard-of-care violations and imposing $107,500 in administrative fines, four years' suspension from the practice of medicine, 200 hours' community service, six years' probation after completion of the suspension, restrictions upon Respondent's license after it is reinstated, coursework, and costs. DONE AND ENTERED this 23rd day of June, 2011, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 23rd day of June, 2011. COPIES FURNISHED: Shirley L. Bates, Esquire Grace Kim, Esquire Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-1701 Sean Michael Ellsworth, Esquire Ellsworth Law Firm, P.A. 1501 Collins Avenue, Suite 208 Miami Beach, Florida 33139 Renee Alsobrook, Acting General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Jr., Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399
The Issue The issues are whether Respondents committed the acts or omissions alleged in four administrative complaints, and, if so, what penalty should be imposed against Respondents' licenses.
Findings Of Fact Petitioner proved the grounds alleged in paragraphs 1 through 3 of each Amended Complaint and the grounds alleged in paragraphs 1 through 5 of each Administrative Complaint. Petitioner is the state agency responsible for regulating the practice of pharmacy in Florida pursuant to Section 20.43 and Chapters 456 and 465. Rx and Gordon are each licensed in Florida, respectively, as a community pharmacy and pharmacist pursuant to license numbers PH 17718 and PS 27618. Rx is a community pharmacy located at 5400 South University Drive, Suite 107, Davie, Florida 33328. Gordon is the pharmacy manager. Rx operates an Internet pharmacy. Rx fills prescriptions received over the Internet and dispenses the prescribed medications. A website company identified in the record as USAPrescriptions.com (USAP) obtains personal information from individuals responding to USAP advertisements on the Internet. USAP transmits the patient information to physicians who prescribe medication for the individuals and transmit the prescriptions and patient information to Rx by e-mail. Rx prints a written record of the electronically transmitted prescription, but the written record of the prescription is not the actual prescription. Rx then enters the patient information into its computer system; fills the prescription; labels the medication in accordance with the requirements of Section 893.04(1)(e); obtains a written confirmation of the prescription from the physician; and dispenses the medication to the patient by private courier. Petitioner conducted on-site inspections of Rx on April 6 and October 18, 2001. Petitioner proved the grounds alleged in paragraph 4(b) of the Amended Complaints. Many of the medications in evidence are controlled substances within the meaning of Section 893.03. None of the controlled substances are Schedule I or Schedule II drugs defined in Section 893.03(1) and (2). Most of the medications are Schedule III, IV, or V drugs defined in Section 893.03(3)-(5). The remaining medications are legend drugs that are not scheduled by statute. Most of the medications in evidence are controlled substances identified in the record as obesity drugs and marketed under the brand names Adipex, Bontril, Didrex, Ionamin, Meridia, Phentermine, and Tenuate. Other medications include Celebrex, Ultram, Valtrex, Viagra, Xenical, and Zyban. Petitioner failed to prove the allegation in subparagraph 4(a) of the Amended Complaints that Respondents filled prescriptions written by out-of-state physicians who prescribed medication based on Internet questionnaires. Rx and Gordon do not fill "written" prescriptions. Respondents fill electronic prescriptions that physicians transmit by e-mail. The electronic prescriptions are transmitted by "other means of communication" authorized in Section 893.02(20). Respondents reduce each electronic prescription to a written record referred to in Section 893.04(1)(a). The evidence is not clear and convincing that physicians prescribe based on Internet questionnaires. None of the prescribing physicians testified. The content of the Internet questionnaire is not established by clear and convincing evidence. The prescribing physicians provide Respondents with patient profiles that include medical information for each patient. Evidence that the patient profiles are an inadequate basis for the prescriptions is less than clear and convincing. Petitioner's experts relied on the adequacy of the patient profiles, in relevant part, to opine that Respondents failed to properly consult patient profiles before dispensing obesity drugs. Evidence that patient profiles were an adequate source of medical information to consult before dispensing drugs is inconsistent with allegations that the patient profiles received from the prescribing physicians were an inadequate basis for the prescription or that the Internet questionnaires did not include sufficient information. Inconsistent evidence and allegations are not clear and convincing. The allegation in paragraph 4(a) that an "out-of-state physician" transmitted the referenced prescription is not material to the statutory mandate for Respondents to determine the validity of the prescription. The statute requires a pharmacist to determine the validity of the prescription only when the prescribing physician is "licensed" in a state other than Florida. The physical location of the physician is immaterial. The trier of fact cannot infer that Petitioner intended to allege a material fact. The fact must be alleged in the plain language of the Amended Complaint. It may be reasonable for the fact-finder to infer that the physician is licensed in the state where he or she is located, but such an inference is less than clear and convincing. The ALJ has ruled that any ambiguity in the factual allegation must be construed in favor of the licensee because this is a license discipline proceeding. The evidence is less than clear and convincing that Gordon was present at Rx on April 6, 2001. The investigator's testimony that he interviewed Gordon on April 6, 2001, is not persuasive. That testimony conflicts with evidence that the investigator customarily documents interviews in his investigative report and did not document an interview with Gordon on April 6, 2001. Such inconsistent evidence is less than clear and convincing. Even if Gordon were found to be present during the inspection, the evidence does not show how long she was present or the nature and scope of her personal conduct concerning the alleged acts or omissions. The evidence is less than clear and convincing that the alleged acts or omissions were caused by misconduct on the part of Rx. The alleged acts or omissions are limited to April 6, 2001. Evidence relevant to the inspection conducted on April 6, 2001, consists primarily of the testimony of one inspector and two exhibits. The evidence is insufficient to show that unidentified employees of Rx engaged in the alleged acts or omissions in a persistent and practiced manner. The evidence is insufficient to support an inference that Rx is vicariously responsible for the alleged acts or omissions of its employees on April 6, 2001. Paragraph 4(c) in the Amended Complaints alleges that the prescriptions filled by Respondents were not valid because there was no patient-physician relationship upon which to base a treatment plan or "to justify prescribing medications." The evidence does not establish standards applicable to Respondents. The investigator's testimony makes clear that the alleged grounds are based on a rule promulgated by the Board of Medicine that is applicable only to physicians licensed in Florida. The ALJ has ruled in the Conclusions of Law that Petitioner has no jurisdiction to discipline Respondents for violating a rule applicable to physicians. No further findings are made concerning the grounds alleged in the Amended Complaints. Paragraph five in the Amended Complaints charges a violation based on facts alleged in the preceding four paragraphs of the complaint. The remaining references in the Recommended Order to a "paragraph" refer to paragraphs in the Administrative Complaints. Paragraph 5 alleges that the "inspection team observed" four technicians and one pharmacist dispensing medications on October 18, 2001, in violation of the maximum ratio of 3:1 prescribed in Section 465.014. The observations of the "inspection team" are a method of proof but, in this instance, include the fact sought to be proven. On October 18, 2001, Gordon was the only pharmacist on duty during the inspection. Four other employees were present at the time, but the evidence is less than clear and convincing that all four employees were technicians. Two members of Petitioner's inspection team found that Respondents maintained the correct ratio. One member is a licensed pharmacist. A third member found the ratio to be improper. Such inconsistent evidence is less than clear and convincing. As to paragraph 6, Petitioner proved that mislabeled drugs were present in the offices of Rx on October 18, 2001. The evidence is clear and convincing that a potentially dangerous pre-packaging procedure occurred on that day. The deficient procedure failed to properly label medications during the re-packaging process. The evidence of personal misconduct by Gordon on October 18, 2001, is less than clear and convincing. Although Gordon was present during the inspection, there is little detailed evidence of her personal conduct. The facts are similar for Rx. The evidence is less than clear and convincing that Rx directed its employees to commit the deficiencies or knew of the deficiencies. Uncontroverted admissions by Rx employees indicate they were instructed to use the deficient procedure to label vials. However, the evidence is insufficient to show that the instructions came personally from Gordon, the owners of Rx, or some other employee or manager. The evidence does not support an inference by the trier of fact that Rx or Gordon is vicariously responsible for the deficiencies. The evidence is insufficient to show that the labeling deficiencies on October 18, 2001, were persistent and practiced. The allegation is limited to a specific day, and the inspection team was not in the offices of Rx all day. The evidence established the standards required for Respondents to exercise due care. The medications were improperly labeled in vials loaded in bins prior to the time that an employee filled a specific prescription. The bins were labeled with the name of the medication and the number of pills. However, the vials did not contain a label stating the strength of the drug, dosage form, manufacturer's lot number or control number, and expiration date as required in Section 499.006(3) and Rule 64F-12.006(1). The standard of care is that the vials must be labeled with the requisite information before filling the vial rather than afterward. The potential for harm from mislabeled drugs is great. It is unsafe and dangerous to keep unlabeled prescription vials containing medications. However, the evidence is not clear and convincing that any actual harm occurred. No finding is made concerning the grounds alleged in paragraph 7. If the facts expressly alleged in paragraph seven were proven, those grounds would not prove any of the remaining charges. Paragraph 7 alleges virtually every fact related to the misuse of a Kirby-Lester machine except that Respondents actually misused the machine by not cleaning it after counting one type of medication and before counting a different type of medication. The allegation is that contamination can occur if the machine is not cleaned between medications. Paragraph 7 does not allege that any member of the inspection team observed Respondents using the machine to count different medications without cleaning the machine between medications. The trier of fact cannot draw an inference that facts not expressly stated were intended to be alleged. The allegation must appear in the plain language of the paragraph. Petitioner failed to prove the grounds alleged in paragraph 8. The evidence is less than clear and convincing that Respondents prepared, packaged, or held drugs under conditions that could contaminate the drugs with filth or render the drugs injurious to health. The evidence is less than clear and convincing that the drugs and drug packaging material referred to in the allegation were part of the dispensing process. The materials were being held for return to the manufacturer. Petitioner submitted no evidence showing that Respondents used the empty vials or vial tops to package medications or that Respondents actually dispensed pills that had been dropped on the floor. The evidence of Gordon's personal conduct concerning the alleged grounds is less than clear and convincing. The evidence does not show that the acts or omissions occurred in a persistent and practiced manner. The evidence is less than clear and convincing that Rx operated an unsanitary, unsafe, or unclean pharmacy or that Gordon managed such a pharmacy. It is reasonable for a busy pharmacy to accumulate debris and clutter on the floor in the course of a busy day. Routine clutter does not render a pharmacy unsafe, unclean, or unsanitary. Petitioner proved the allegation in paragraph 9 that unnamed employees at Rx received approximately 764 prescriptions on October 5, 2001, and that the prescriptions were not signed. Petitioner failed to prove that the prescriptions were written and required by law to be signed. The unsigned documents are not prescriptions within the meaning of Section 893.02(20). They are the written record of prescriptions that are transmitted electronically over the Internet. Paragraph 9 refers to Rule 64B8-9.012(4). That rule is promulgated by the Board of Medicine and applies to physicians. Respondents are not physicians. Petitioner proved part of the grounds alleged in Paragraph 10 but failed to prove a material ground. No finding is made regarding the remaining ground. Petitioner proved that Section 893.02(20) contains the provision quoted in paragraph 10. For reasons stated in paragraphs 9 through 11 of the Findings of Fact, evidence of the basis upon which the prescribing physicians ordered medications is less than clear and convincing. No finding is made concerning the allegation that "many of these . . . controlled substances . . . were prescribed. . . ." The prescribing physicians did not testify, and Respondents do not prescribe medications. Respondents fill prescriptions and dispense medications. No finding is made concerning paragraph 11. Paragraph 11 does not allege that Respondents committed any specific act or omission. Paragraph 11 recites Section 465.003(14). No finding is made concerning paragraphs 12 and 13. The grounds alleged in both paragraphs pertain to physicians rather than pharmacists. In relevant part, paragraph 14 alleges: Accordingly, Respondent is dispensing obesity medications prescribed without benefit of a valid patient/physician relationship in violation of Section 465.016(1)(i). . . For purposes of Section 465.016(1)(i) . . ., it shall be legally presumed that the . . . dispensing of . . . drugs in excessive or inappropriate quantities is not in . . . the course of the professional practice of pharmacy. Also, the practice constitutes violations of sections 894.04(1) and 893.02(20). . . for dispensing controlled substances outside the course of the professional practice of pharmacy by failing to determine whether the prescriptions were issued pursuant to a valid patient/physician relationship, and by failing to determine that the drugs so ordered are considered necessary for the continuation of treatment of a chronic or recurrent illness. (emphasis supplied) Paragraph 14 charges that Respondents violated the referenced statutes based on antecedent facts alleged in paragraphs 9 through 13 and incorporated by reference through terms such as "accordingly" and "the practice." Related counts in paragraphs 66-88 or 90 contain substantially similar charges based on facts alleged in paragraphs 1-65. The charges in paragraph 14 and related counts are read together to include relevant factual allegations in paragraphs 1-65. Section 893.02(20), in relevant part, requires a pharmacist to determine whether prescriptions from a physician licensed in a state other than Florida are issued pursuant to a valid patient-physician relationship, are authentic, and are necessary for the continuation of treatment of a chronic or recurrent illness (the validity test). The terms of the validity test are susceptible to different interpretations. The validity test could be construed to require a pharmacist to determine whether the physician considers the patient-physician relationship to be valid, the prescription authentic, and the drugs necessary. Alternatively, the validity test could require the pharmacist to substitute the pharmacist's judgment for that of the physician. The ALJ has determined that any ambiguity in the terms of the validity test must be construed in favor of Respondents and against the imposition of discipline. The ALJ has also determined that a requirement for a pharmacist to substitute her or his judgment to determine the medical necessity of medication may, in some cases, require the licensee to practice medicine. Respondents exercise reasonable care to ensure that the validity test has been satisfied, when applicable, by requiring the prescribing physician to sign a written verification of the prescriptions ordered by that physician. Respondents do not fill any prescription before Respondents receive a "site fill list" or "daily log" signed by the prescribing physician to verify the authenticity of the prescription, the validity of the patient-physician relationship, and the medical necessity of the medication. If pharmacists were required to substitute their judgment for that of prescribing physicians, the standards for exercising that judgment are less than clear and convincing. The requirement for a licensee to determine the validity of the patient-physician relationship applies only if the physician is licensed in a state other than Florida. Standards used to determine the validity of a patient-physician relationship vary from state to state. Clear and convincing evidence does not indicate whether a Florida pharmacist must apply Florida law to make the necessary determination or must apply the law of the state where the prescribing physician is licensed. Petitioner relies on an unwritten agency statement by the Board of Pharmacy to explicate the standards that pharmacists must use in determining the validity of a patient- physician relationship. The agency statement requires licensees to determine whether a prescribing physician, licensed in any state including Florida, has conducted an in-person examination of the patient prior to prescribing a medication. The agency statement holds that the absence of an in-person examination renders the prescription invalid. Findings pertaining to the agency statement are discussed further in the Conclusion of Law because continuity requires a simultaneous discussion of both findings of fact and conclusions of law. The charge in paragraph 14 that Respondents dispense excessive or inappropriate quantities of legend drugs is equivalent to charges in Count Two against Rx and Count Four against Gordon. Facts relevant to those charges are alleged in paragraphs 9, 15, 16, 17, and 20 through 22 of the Administrative Complaints. Paragraphs 25, 26, and 29 in the Administrative Complaint against Rx allege additional relevant facts, as do paragraphs 26, 27, and 30 in the Administrative Complaint against Gordon. In relevant part, paragraph 9 alleges that on October 5, 2001, Respondents received 764 prescriptions from three physicians identified in the record as Drs. Rosenkrantz, Rivera, and Thompson. Paragraphs 15 through 17 allege that two drugs marketed under the names Phentermine and Bontril are controlled substances that have a high potential for abuse. Respondents stipulated to paragraphs 15 through 17. Paragraph 20 alleges that many of the controlled substances are for a three-months' supply per purchase. Paragraph 21 alleges that the PDR states that tolerance for the anorectic effect of many obesity drugs occurs after a "few weeks," and that the drug should be discontinued at that time rather than increased to overcome tolerance. Paragraph 22 alleges that Respondents filled hundreds of prescriptions for obesity drugs each day included in the business practices described in paragraphs 1 through 21. The business practices described in paragraphs 1 through 21 are for the dates that occurred from October 5 through 18, 2001. Paragraphs 25 and 26 pertaining to Rx, and paragraphs 26 and 27, pertaining to Gordon, allege that Petitioner's investigator obtained the written record of additional prescriptions when an employee for Rx produced the documents on October 24, 2001. Paragraph 29, pertaining to Rx, and paragraph 30, pertaining to Gordon, allege that the computer operated by Rx showed that Rx and its employees dispensed 17,410 tablets of Phentermine on December 5, 2001; and that a daily log dated September 4, 2001, showed that Rx employees received 300 prescriptions from Dr. Rivera. The facts alleged to support the charges of dispensing excessive or inappropriate quantities of legend drugs involve dates from September 4 through December 6, 2001 (the relevant period). Within the relevant period, the enumerated paragraphs together allege that Rx and Gordon dispensed excessive and inappropriate quantities of legend drugs including: hundreds each day; 17,410 tablets on December 5, 2001; and 300 from Dr. Rivera on September 4, 2001. The relevant paragraphs also allege that many of the legend drugs were obesity drugs such as Bontril and Phentermine; and that many drugs were dispensed pursuant to prescriptions for 90 days' supply per purchase. The relevant paragraphs further allege methods of proof, including documents received on October 24, 2001, provisions of the PDR, and documents collected by the inspectors. The evidence is less than clear and convincing that Gordon personally dispensed drugs during the relevant period. There is insufficient evidence, or allegations, to show when Gordon was present at the pharmacy, for how long, or if her duties required her to fill prescriptions and dispense drugs. The evidence is less than clear and convincing that Gordon is vicariously responsible for drugs that others dispensed during the relevant period. Although the evidence is clear that drugs were dispensed in a persistent and practiced manner, there is insufficient evidence for the trier of fact to draw an inference that Gordon was vicariously responsible. Petitioner did not prove that Gordon was the only manager during the relevant period. Paragraph 5 of the Administrative Complaints alleges that, on October 18, 2001, Gordon identified another person present at the pharmacy as the owner. The next allegations concerning Gordon's management control over pharmacy operations pertain to the inspection conducted on January 31, 2002. The allegations and evidence are insufficient to differentiate the duties of Gordon and others with management control. The evidence is insufficient to show which days various managers were present, what specific duties each performed, and how the managers allocated management responsibilities among themselves. The evidence is less than clear and convincing that Gordon had any management control over those who dispensed medications during the relevant period. There is no doubt that Rx dispensed large quantities of medication during the relevant period. Employees at Rx dispensed approximately 1,942 legend drugs during the relevant period. That is a practiced and persistent manner of dispensing drugs regardless of which employees dispensed the drugs. Large quantities of drugs are not necessarily excessive or inappropriate quantities. Petitioner stipulated during the hearing that a determination of whether quantities are excessive or inappropriate must be made "per patient" and not by reference to the pharmacy. The evidence of prescriptions filled by Rx consists of Petitioner's Exhibits 59, 62, 63, 76, 77, 87, 88, 90, 92, and 94 (P59, P62, etc.). The prescriptions were filled from January 11, 2001, through April 26, 2002. Prescriptions evidenced in P87, P88, and P92 are outside the relevant period. Of the remaining prescriptions, the prescriptions that are essential to the opinion of Petitioner's expert are set forth in P94. That exhibit consists of a Site Fill List, or daily log, maintained by Rx for the period from September 4 through October 10, 2001. Petitioner's expert identified 102 instances in P94 in which he opined that medications were dispensed to individual patients in excessive or inappropriate quantities. The instances relied on by Petitioner's expert may be fairly summarized as follows: Item Date Patient Drug Dose/Quantity 1. 9/20 L.A. Phentermine(P) 30mg/30 2. 9/20 L.A. P 30mg/30 3. 9/20 L.W. P 30mg/90 4. 9/20 L.W. Meridia (M) 15mg/90 5. 9/4 K.Co. Diethylpropion(DP) 75mg/90 6. 9/4 K.Cu P 30mg/90 7. 9/10 A.J. Adipex (A) 37.5mg/90 8. 9/10 A.J. Didrex (D) 50mg/30 9. 9/10 A.J. Adipex (A) 37.5mg/90 10. 9/10 A.J. Didrex (D) 50mg/30 11. 9/11 D.B. Bontril (B) 105mg/90 12. 10/2 D.B. B 105mg/90 13. 10/2 K.Sg. P 15mg/90 14. 10/1 K.Sg. P 30mg/90 15. 9/4 I.To. P 30mg/30 16. 9/26 I.To. P 37.5mg/90 17. 10/1 I.Tr. A 37.5mg/90 18. 10/5 I.Tr. A 37.5mg/90 19. 10/3 I.Tr. Celebrex 200mg/50 20. 10/5 I.Tr. Xenical 120mg/270 21. 9/10 D.Ha. A 37.5mg/90 Item Date Patient Drug Dose/Quantity 22. 9/6 D.Ha. P 30mg/90 23. 10/10 J.H. M 10mg/30 24. 10/5 J.H. P 30mg/90 25. 9/6 D.Ht. D 50mg/30 26. 9/7 D.Ht. D 30mg/30 27. 9/28 L.M. Viagra 100mg/30 28. 9/28 L.M. Viagra 100mg/30 29. 9/5 J.S. P 30mg/30 30. 9/24 J.S. P 30mg/30 31. 10/1 J.S. P 30mg/90 32. 9/25 Z.H. P 30mg/30 33. 9/25 Z.H. P 30mg/30 34. 9/5 D.I. A 37.5mg/30 35. 9/6 D.I. A 37.5mg/30 36. 10/10 L.Z. D 50mg/90 37. 10/8 L.Z. P 30mg/90 38. 9/17 T.W. A 37.5mg/30 39. 9/14 T.W. P 37.5mg/90 40. 9/20 L.A. P 30mg/30 41. 9/20 L.A. P 30mg/30 42. 9/17 A.E. P 30mg/30 43. 9/24 A.E. P 30mg/90 44. 9/27 D.P. A 37.5mg/90 45. 9/26 D.P. P 30mg/90 46. 10/5 K.Sh. A 37.5mg/30 47. 10/5 K.Sh. P 37.5mg/30 48. 10/5 P.S. P 30mg/90 49. 9/27 P.S. P 37.5mg/30 50. 9/10 M.F. P 30mg/90 51. 9/10 M.F. P 30mg/90 52. 9/24 A.G. A 37.5mg/30 53. 9/6 A.G. B 105mg/30 54. 9/4 B.A. DP 75mg/30 55. 9/4 B.A. DP 75mg/30 56. 9/17 M.S. P 37.5mg/90 57. 9/20 M.S. P 37.5mg/90 58. 10/9 V.S. P 30mg/90 59. 9/24 V.S. P 37.5mg/90 60. 9/17 D.Cd. P 37.5mg/90 61. 9/4 D.Cf. P 37.5/90 62. 9/26 J.Ws. P 30mg/90 63. 9/27 J.Ws. P 37.5mg/90 64. 9/25 R.R. B 105mg/30 65. 9/24 R.R. B 105mg/90 66. 9/10 A.J. A 37.5mg/90 Item Date Patient Drug Dose/Quantity 67. 9/10 A.J. D 50mg/30 68. 9/28 K.J. P 30mg/90 69. 10/1 K.J. P 30mg/90 70. 9/12 S.F. P 30mg/30 71. 9/12 S.F. P 30mg/30 72. 10/3 S.F. P 30mg/30 73. 10/3 D.M. A 37.5mg/30 74. 10/5 D.M. A 37.5mg/30 75. 9/14 P.G. DP 75mg/30 76. 9/14 P.G. DP 75mg/90 77. 9/17 M.I. P 30mg/30 78. 9/21 M.I. P 30mg/90 79. 9/19 T.H. Viagra 100mg/20 80. 9/18 T.H. Viagra 100mg/30 81. 9/12 C.C. Ionamin (I) 30mg/90 82. 9/5 C.C. P 37.5mg/30 83. 9/21 M.P. D 50mg/30 84. 9/25 M.P. D 50mg/90 85. 9/4 K.H. A 37.5mg/30 86. 9/28 K.H. A 37.5mg/30 87. 10/10 K.H. A 37.5mg/30 88. 10/3 A.C. Viagra 100mg/10 89. 10/3 A.C. Viagra 100mg/10 90. 9/24 K.K. P 37.5mg/30 91. 10/2 K.K. P 37.5mg/90 92. 9/6 J.Wi. A 37.5mg/30 93. 9/19 J.Wi. D 37.5mg/30 94. 9/5 T.W. A 37.5mg/30 95. 9/19 T.W. A 37.5mg/30 96. 10/8 T.W. A 37.5mg/30 97. 9/28 A.M. P 30mg/30 98. 10/9 A.M. P 30mg/30 99. 9/17 S.K. Viagra 100mg/10 100. 9/17 S.K. Viagra 100mg/10 101. 10/5 C.K. Ultram 50mg/30 102. 10/8 C.K. ULtram 50mg/90 The appropriateness of a quantity of medication is determined by reference to the medical profile of a particular patient. The evidence is less than clear and convincing that the quantities of dispensed medication were inappropriate. Evidence and allegations concerning patient profiles are inconsistent. Petitioner alleges in its complaints that information in patient profiles provided an insufficient basis for the prescribing physician to order medication. However, witnesses for Petitioner opined that Respondents deviated from the professional practice of pharmacy by failing to consult the profiles. The necessary implication is that the profiles contained sufficient medical information for Respondents to consult before dispensing medication. There would be no rational reason to consult an invalid patient profile. Other evidence suggests the patient profiles contain insufficient medical information. The apparent inconsistency was confusing, contributed to a hesitance in the mind of the trier of fact that either proposition was true, and eroded the credibility of expert testimony that Rx employees dispensed medication in inappropriate quantities to particular patients. A medication is dispensed in an excessive quantity if the quantity dispensed exceeds the maximum recommended quantity for the medication. Petitioner cited no statute or rule that defines the term "quantity." The plain and ordinary meaning of the "quantity" of a drug is the "measurable [or] countable . . . property" of the drug. The American Heritage Dictionary of the English Language, 1432 (4th ed. 2000). The trier of fact measured the total medication dispensed pursuant to a single prescription by the total milligrams of medication dispensed. Rx employees dispensed obesity drugs evidenced in P94 in the form of pills. The total medication dispensed by pill is a mathematical product equal to the strength of each pill multiplied by the number of pills, including refills. The evidence is less than clear and convincing that prescriptions in P94 included refills. Petitioner cited no statute or rule that identifies the maximum recommended quantity for the obesity drugs at issue. Rather, a combination of expert testimony and the maximum strengths evidenced in P94 establish a maximum recommended quantity for the obesity drugs at issue. The trier of fact determined that obesity drugs in P94 were dispensed in excessive quantities if the total medication dispensed to a patient within 90 days exceeded the total medication in 90 pills, at the maximum strength for each pill, taken once a day for 90 days (the 90-day standard). Evidence of which obesity drugs have a lower quantity standard is less than clear and convincing. It is clear, however, that any of the obesity drugs in P94 are dispensed in excessive quantities if the total dispensed medication exceeds the total medication in the 90-day standard. The evidence is less than clear and convincing that the total dispensed medication was excessive in item numbers 1, 2, 7 through 10, 40, 41, 66, and 67. Items 1, 2, 40, and 41 may be duplicates as may be the case for items 8, 10, and 67; and 7, 9, and 66. The trier of fact has sufficient doubt as to whether the opinions based on the enumerated items are true. The evidence is less than clear and convincing that the total dispensed medication was excessive in items 19, 20, 27, 28, 79, 80, 88, 89, and 99 through 102. Those items show that the medications are not obesity drugs. Evidence of the quantity standards for legend drugs other than obesity drugs is less than clear and convincing. The evidence is less than clear and convincing that total dispensed medication was excessive in connection with items 5, 6, 25 and 26, 32 through 35, 46 and 47, 52 through 55, 60, 61, 70 through 74, 85 through 87, and 92 through 98. Patient names in items 5 and 6 and 60 and 61 are different. Where patient names are the same for two prescriptions, the total medication dispensed pursuant to both prescriptions does not exceed the 90-day standard. The evidence is clear and convincing that the total dispensed obesity medication exceeded the 90-day standard in several instances. Those instances are evidenced in items 3 and 4, 11 through 18, 21 through 24, 29 through 31, 36 through 39, 42 through 45, 48 through 51, 56 through 59, 62 through 65, 68 and 69, 75 through 78, 81 through 84, and 90 and 91. Neither the strength of each pill nor the number of pills dispensed pursuant to a single prescription caused total dispensed medication to exceed the total medication in the 90- day standard. Total dispensed medication generally exceeded total medication in the 90-day standard when employees dispensed an obesity drug to a patient pursuant to a second prescription within 90 days of the first. In items 29 through 31, however, the excess occurred when obesity drugs were dispensed pursuant to a third prescription in item 31 within 90 days of the first two prescriptions in items 29 and 30. Therefore, the 49 items enumerated in the preceding paragraph evidence only 24 instances of excessive quantities of obesity drugs. The total dispensed medication exceeded the total medication in the 90-day standard in three types of fact patterns. In one fact pattern, Rx employees dispensed the same brand name obesity drug to a patient at the maximum strength pursuant to two prescriptions within 90 days. In item 11, for example, Rx employees dispensed 90 pills of Bontril at the maximum strength of 105 milligrams per pill. In item 12, they dispensed the same quantity approximately 22 days later. The total dispensed medication within 90 days is equal to the product of 180 pills multiplied by 105 milligrams, or 18,900 milligrams. The total medication in the 90-day standard is 90 pills at 105 milligrams, or 9,450 milligrams. The excessive quantity is the excess of the dispensed medication (18,900) over the medication in the 90-day standard (9,450). The excessive quantity evidenced in items 11 and 12 is 9,450 milligrams. By similar calculations, the excessive quantity in items 56 and 57 is 3,375 milligrams. The excessive quantity in items 64 and 65 is 3,150 milligrams. In items 75 and 76, 83 and 84, and 90 and 91, the excessive quantities are 2,250, 1,500, and 1,125 milligrams, respectively. In the second fact pattern, Rx employees dispensed the same brand name obesity drug to a patient at less than the maximum strength pursuant to two or more prescriptions within 90 days. In item 14, for example, Rx employees dispensed 90 pills of Phentermine at a strength of 30 milligrams per pill. In item 13, they dispensed 90 pills of the same drug the next day at 15 milligrams per pill. The total medication dispensed within 90 days is equal to the sum of the total milligrams dispensed in each instance, or 4,050 milligrams. The total medication in the 90-day standard is 90 pills at 37.5 milligrams, or 3,375 milligrams. The excessive quantity is the excess of the dispensed medication (4,050) over the medication in the 90-day standard (3,375). The excessive quantity evidenced in items 13 and 14 is 675 milligrams. By similar calculations, the excessive quantities in items 15 and 16, 29 through 31, 42 and 43, 48 and 49, 50 and 51, 58 and 59, 62 and 63, 68 and 69, and 77 and 78, respectively, are 900, 1,125, 225, 450, 2,025, 2,700, 2,700, 2,025, and 225 milligrams. In the third fact pattern, Rx employees dispensed different brand name obesity drugs in different strengths pursuant to two prescriptions within 90 days. In item 3, for example, Rx employees dispensed 90 pills of Phentermine at 30 milligrams per pill. In item 4, they dispensed 90 pills of Meridia on the same day at 15 milligrams per pill. The total medication dispensed within 90 days is equal to the sum of the milligrams dispensed in each instance, or 4,050 milligrams. The total medication in the 90-day standard is 90 pills at 37.5 milligrams, or 3,375 milligrams. The excessive quantity is the excess of the dispensed medication (4,050) over the medication in the 90-day standard (3,375), or 675 milligrams. By similar calculations, the excessive quantities in items 21 through 24, 36 through 39, 44 and 45, and 80 and 81, respectively, are 2,975, 1,575, 2,700, and 450 milligrams. Rx employees dispensed obesity drugs in the three fact patterns just discussed in an aggregate excessive quantity of 42,275 milligrams. The average excessive quantity for each of the 24 instances found in P94 is 1,761 milligrams. The average excess quantity correlates to a 90-day excess of approximately 17 pills at a maximum strength of 105 milligrams, 23 pills at 75 milligrams, 35 pills at 50 milligrams, 47 pills at 37.5 milligrams, and 117 pills at 15 milligrams. The ALJ has concluded that Section 465.016(1)(i) creates a legal presumption that the excessive quantities of obesity drugs dispensed by Rx employees were not dispensed in the course of the practice of pharmacy. Rx did not rebut the statutory presumption with persuasive evidence that explains the quantities of medications dispensed or rebuts the quantity standards in evidence. Respondents' expert relied on substantially the same evidence as that relied on by Petitioner's expert and opined that Respondents dispensed medication in accordance with the professional practice of pharmacy. However, that opinion was an ultimate conclusion that was not fact specific and did not cast doubt on the details that gave rise to the statutory presumption. That opinion was not persuasive. Rx argues that Petitioner did not show that the prescriptions were actually filled, did not sufficiently identify the patients, and did not show that the patients actually received the medications. Those arguments are neither credible nor persuasive. They do not create a hesitance in the mind of the trier of fact concerning the details supporting the statutory presumption. Information in P94 is part of the QS1 system. The instances of excessive quantities of medications provide a sufficient basis for the trier of fact to find that Rx is vicariously liable for Rx employees who dispensed obesity drugs in excessive quantities in the 24 instances evidenced in P94. The instances are not isolated events. During the 26 days evidenced in P94, the 24 instances of excessive quantities occurred, on average, almost once a day. That evidence shows that Rx employees dispensed excessive quantities of obesity drugs in a persistent and practiced manner. Rx did not require its employees to comply with the standard of conduct evidenced in expert testimony. In the absence of an adequate alternative, Rx employees must personally review site fill lists to ensure that quantities are not excessive. Rx employees do not personally review site fill lists. Rather, Rx permits its employees to rely on the QS1 computer system for that and other purposes. Reliance on the QS1 computer system was reasonable and was made in good faith. The QS1 is a computer system commonly utilized by pharmacies. The system maintains inventory, patient profiles, and patient addresses and phone numbers. The QS1 system enables Rx to capture and monitor patient profiles in dispensing medications. The evidence is less than clear and convincing that the information in the patient profiles is inaccurate or inadequate. Rx employees enter a prescription into the QS1 system and then retrieve the prescribed medication from inventory. If the medication has not been pre-packed, the employee counts the medication and places it in a vial. If the medication has been pre-packed, Rx labels the medication. The QS1 system alerts Rx employees to any particular problems that a patient may have as a result of the prescribed medication. If an Rx employee receives an alert, she or he reviews the patient profile and resolves the problem. Once the prescription is prepared for dispensing, Rx pharmacists compare the prescription with the vial label to ensure accuracy. Rx employees then place the medication in an envelope for shipping but do not actually ship the medication until they receive a signed copy of the daily log from the prescribing physician verifying that the physician has not prescribed medication in excessive quantities. The daily log is not a prescription but is an extra step taken by Rx to ensure the accuracy of the order for medication. The QS1 system performed its purpose well when measured by statistical standards. There are approximately 1,942 prescriptions listed in P94. Only 24 of those were for excessive quantities of obesity drugs. The QS1 system achieved an error rate of approximately 1.23 percent. That rate of error, however, produced excessive quantities of medication almost once a day for 26 days. Rx relied on the QS1 system in filling approximately 154,773 prescriptions between October 19, 2001, and April 26, 2002. If the QS1 system were to maintain an error rate of 1.23 percent during that period, the mathematical probability is that Rx would have dispensed excessive quantities of medication in 1,903 instances over approximately 190 days for an average of approximately 10 instances a day. If the excess quantity in each instance were equal to 1,761 milligrams, according to the average determined in paragraph 76 of the Findings of Fact, Rx would have dispensed 17,644 milligrams of excess medication each day and 3,352,429 milligrams of excess medication in 190 days. An error rate of 1.23 percent represents a significant potential for harm. However, the evidence of actual harm is less than clear and convincing. Rx dispensed excessive quantities of obesity drugs in 24 instances evidenced in P94. Rx dispensed the medication irrespective of whether the patients actually received it. Receipt is a relevant inquiry to determine harm to an identified recipient. Receipt does not determine whether Rx employees dispensed obesity drugs from the pharmacy. The grounds alleged in paragraphs 15 through 17 are not disputed. Paragraph 18 alleges, in relevant part: The concept of dispensing . . . scheduled drugs by permitting them to be specifically requested and 'ordered' over the internet is a potentially dangerous method of allowing . . . medications to be 'taken on the user's own initiative rather than on the basis of professional medical advice. ' Dispensing controlled . . . drugs in this manner by Respondent[s] runs contrary to the spirit, intent, and purpose of chapter 893 with regard to protecting the safety of the public. (emphasis supplied) No findings are made concerning the grounds alleged in paragraph 18. The trier of fact cannot discern what specific acts or omissions paragraph 18 alleges. Paragraph 18 implies that Respondents somehow transformed a "concept" into a "method" but does not allege any specific acts or omissions by which Respondents effectuated the transformation. Paragraph 18 is devoid of patient names, dates, specific transactions, details, and other allegations of essential facts. Several allegations in paragraphs 19 through 21 concern the "Physician's Desk Reference" (PDR). Other than those findings already made, the trier of fact is uncertain what Petitioner intends to allege in paragraphs 19 through 21. The PDR is a method of proving a fact not alleged. Evidence of the legal effect of the PDR in this proceeding is less than clear and convincing. Petitioner failed to sufficiently evidence the specific standards allegedly enunciated in the PDR. The allegation is that the PDR states that obesity drugs should be discontinued within a "few weeks." Petitioner failed to define a "few weeks" with clear and convincing evidence as any period less than 90 days. The remaining grounds alleged in paragraphs 19 through 21 recite or paraphrase provisions of the PDR. No further findings are made concerning paragraphs 19 through 21. Petitioner proved the allegation in paragraph 22 that Rx dispensed hundreds of medications each day from October 5 through 18, 2001. Petitioner did not prove the remaining grounds alleged in paragraph 22. For reasons stated in paragraphs 9 through 11 of the Findings of Fact, evidence of the allegation in paragraph 22 that prescribing physicians wrote and submitted prescriptions based solely on information received from Internet questionnaires is less than clear and convincing. Information included in the Internet questionnaires is not established by the requisite standard of proof. No finding is made concerning the grounds alleged against Rx in paragraphs 23 through 24 or those alleged against Gordon in paragraphs 23 through 25. Petitioner concedes in its PRO at pages 27 through 28 that Petitioner did not prove grounds supporting the charges that: Respondents failed to report violators to Petitioner; and used USAP to promote or advertise the use or sale of controlled substances. Petitioner proved the grounds alleged against Rx in paragraphs 25 and 26 and those alleged against Gordon in paragraphs 26 and 27. Respondents produced the written record of prescriptions requested by the inspector. Respondents conferred with their attorney before producing the documents. The grounds alleged in paragraphs 27 through 36 against Rx and in paragraphs 28 through 37 against Gordon pertain to an inspection conducted by Petitioner on December 6, 2001. Petitioner proved some of the grounds alleged against Rx in paragraphs 27 and 28 and some of those alleged against Gordon in paragraphs 28 and 29. The evidence shows that Gordon was not present at the pharmacy during the inspection on December 6, 2001. The evidence is less than clear and convincing that Gordon worked at the pharmacy that day. The evidence is insufficient to prove that Gordon committed the acts or omissions alleged in paragraphs 28 through 31 or that the acts or omissions of others were so persistent and practiced during that period that Gordon was vicariously responsible for their acts or omissions. Petitioner proved some of the grounds alleged against Rx in paragraph 27. When the inspector first arrived, two technicians and an administrator were visible to the inspector. Two pharmacists greeted the inspector within 15 minutes of his arrival at Rx. No sign was posted that the pharmacists were out to lunch or on break. The evidence is less than clear and convincing that both pharmacists were out to lunch or on break. One of the pharmacists may have been in the bathroom or otherwise available for questions from technicians. Respondents argued during the hearing that legislation identified in the record as the "potty bill" carves out an exception to the requirement to post a sign when a pharmacist goes to the bathroom. Although the argument does not evidence the "potty bill," the argument creates sufficient doubt in the mind of the trier of fact concerning the issue of whether both pharmacists were out to lunch. Evidence of the whereabouts of the second pharmacist is less than clear and convincing. Evidence defining the term "[l]ater" is less than clear and convincing. Petitioner failed to prove the allegations in paragraph 28 that a technician was working "alone" or was "unsupervised." If it were found that Rx committed the charged violation, there would be no potential or actual harm. The requirement for a sign has little meaning for an Internet pharmacy such as Rx. The testimony of several witnesses for Petitioner makes clear that Rx is not open to patients who physically walk into the pharmacy and present written prescriptions. The front door is frequently locked. At least one investigator had to knock on the front door to gain access. Patients who fill their prescriptions at Rx "walk in" electronically and are unable to read any sign posted inside the pharmacy. The only persons who would benefit from such a sign would be those employed at the pharmacy. More likely than not, Rx employees do not need a sign to tell them a pharmacist is not in the same room with them. The evidence is less than clear and convincing that Rx employees failed to properly label drugs on December 6, 2001. The plain terms of paragraph 28 admit that Rx complied with all but one of the labeling requirements in Rule 64F-12.006(1)(a) by ensuring that its employees place pills in vials labeled with all of the requisite information except dosage form. The evidence is less than clear and convincing that the labels did not include dosage form. The evidence is less than clear and convincing that Rx placed the labeled vials with "unsigned prescriptions." Rather, the preponderance of evidence shows that the unsigned documents are the written record of electronic prescriptions and not unsigned written prescriptions. Petitioner proved the allegations against Rx in paragraph 29. The dates alleged in paragraph 29 are included in previous findings that Rx dispenses large numbers of medications ordered by Drs. Rosenkrantz, Rivera, and Thompson. Petitioner did not prove substantially similar allegations against Gordon in paragraph 30. Petitioner did not prove the allegations in paragraph 30 and 31 that Rx and Gordon knowingly possessed mislabeled drugs. The evidence is less than clear and convincing that Rx employees possessed mislabeled drugs or, if so, that Rx or Gordon are vicariously responsible for that deficiency. The grounds alleged to have occurred on December 6, 2001, are not supported by the quantum or quality of evidence that supports the finding of mislabeled drugs on October 18, 2001. Evidence of grounds arising from the inspection on December 6, 2001, primarily consists of the testimony of one inspector and three exhibits. The photographs in evidence pertain to the inspection conducted on October 18, 2001. Petitioner's experts relied on those photographs, in relevant part, in rendering their opinions concerning allegations that Rx knowingly possessed mislabeled drugs. Expert opinions are unnecessary to assist the trier of fact in determining whether Rx possessed mislabeled drugs on any date. The trier of fact is capable of making that determination based on the standards enunciated in the applicable rules, the testimony of the fact witnesses, and the pictures and documents that support their testimony. Grounds alleged against Rx in paragraphs 31-36, and those alleged against Gordon in paragraphs 32-37, arise from a re-inspection conducted on January 31, 2002. Like the evidence pertaining to the inspection on December 6, 2001, grounds arising from the inspection on January 31, 2002, are not supported by the quantum or quality of evidence that supports the inspection of October 18, 2001. Petitioner must prove the grounds arising from each inspection by clear and convincing evidence. The trier of fact cannot draw an inference from the findings pertaining to October 18, 2001, to bolster the evidence submitted for the other inspections. If it were found that evidence concerning each inspection satisfied the clear and convincing standard of proof, it would be appropriate for the trier of fact to consider all of the inspections in determining whether the alleged deficiencies were so persistent and practiced that they supported an inference of vicarious responsibility. The evidence is less than clear and convincing that the alleged grounds arising from the inspection on January 31, 2002, are true. The preponderance of evidence shows a bin containing unlabeled vials of medication was on top of a counter on one side of a room in the pharmacy. On the other side of the room, all of the medication vials and bins were labeled. The medication in the bin by itself was separated from medication in the pharmacy's active stock. Bins of medication containing active stock were labeled. It is unlikely the separated medication would be inadvertently dispensed. Medication in the separated bin was not labeled because it was being returned to the manufacturer. Respondents did not hold medication in the separated bin to be dispensed. The grounds alleged against Rx in paragraphs 37 through 65 and against Gordon in paragraphs 38 through 65 pertain to complaints filed by T.M. and J.W. For convenience, a finding pertaining to the cited paragraphs may contain references to more than one paragraph. References to a lower numbered paragraph, or group of paragraphs, refer to the grounds alleged against Rx. References to a higher numbered paragraph, or group of paragraphs, refer to grounds alleged against Gordon. Petitioner proved the grounds alleged in paragraphs 37 (against Rx) and 38 (against Gordon). Petitioner proved some of the grounds alleged in paragraphs 38 through 48 and 39 through 49 and portions of the grounds alleged against Rx in paragraph 52. On October 21, 2001, T.M. opened an e-mail from USAP and responded with information about her. T.M. purchased 90 tablets of Phentermine and paid $169 to USAP by credit card. T.M. subsequently returned the medication and received a refund. T.M. received the medication by overnight delivery. The vial label indicated Rx dispensed the medication. The label listed Dr. Rivera as the prescribing physician. T.M. never saw Dr. Rivera or heard of Rx or Gordon before receiving the medication. T.M. did not choose Rx as a pharmacy and did not choose Gordon as a pharmacist. T.M. attempted to return the medication for a refund. T.M. spoke by telephone to a representative of USAP. The representative denied T.M.'s request for refund. T.M. telephoned Rx at the number provided on the prescription label. T.M. spoke to a female who identified herself as a pharmacist and answered with a heavy accent. It is not clear that Gordon has a heavy accent. T.M. had no technical questions of the medication dispensed by Rx. The pharmacist stated that she could not help T.M. with her refund and referred T.M. back to USAP. The remaining testimony of T.M. is less than clear and convincing. On cross examination, T.M. distinctly recalled few, if any, facts. Her testimony was neither precise nor specific. T.M. was confused as to material facts in issue. Petitioner failed to prove the remaining grounds alleged in paragraphs 38 through 48 and 39 through 49. The ALJ ruled that evidence of the statements made in the USAP website is hearsay and that Sections 120.57(1)(c) and (l) prohibit the trier of fact from basing a finding on anything less than competent and substantial evidence. There is less than clear and convincing evidence that the website does not afford patients a choice in pharmacies. If it were found that the USAP website failed to offer a choice of pharmacies, the evidence is less than clear and convincing that Respondents knowingly participated in a system that does not afford a choice in pharmacies. USAP is located in the same building that Rx occupies at 5400 University Drive. Any further findings would require the fact-finder to draw an inference based on insufficient evidence. The evidence is less than clear and convincing that Rx controls the operations of USAP; that Rx and USAP are sibling or related companies, or share common officers, managers, directors, or employees; or that Rx has any legal or actual influence in the management or operation of USAP. The evidence is less than clear and convincing that Respondents had editorial control or input into the content and operation of the website used by USAP in the conduct of USAP's business; or that Respondents knew the content of the website. For similar reasons, evidence of the grounds alleged in paragraphs 53 through 65 concerning the content of the USAP website is less than clear and convincing. Petitioner failed to prove the grounds in paragraphs 43 and 44 alleging that the obesity medication prescription for T.M. was not written within the course of the professional practice of medicine. The prescriptions were not written. Petitioner failed to prove the grounds alleged in paragraphs 49 through 51 and 50 through 52. Operative terms in Section 893.02(20) apply to a pharmacist and not to a pharmacy. A pharmacist and a pharmacy are defined separately in Section 465.03(10) and (11). Section 893.02(20) does not require a pharmacy, including Rx, to make any determination regarding the validity test defined in paragraph 42 of the Findings of Fact. Section 893.02(20) requires Gordon to apply the validity test only if Gordon receives a prescription ordered by a physician licensed in a state other than Florida. While the statute necessarily requires Gordon to determine the state in which the prescribing physician is licensed before Gordon can know whether to apply the validity test, the evidence is less than clear and convincing that Gordon failed to perform her statutory duty. Petitioner did not submit any competent substantial evidence that Drs. Rosenkrantz, Rivera, and Thompson are licensed in a state other than Florida. Sufficient evidence of the statutory prerequisite to the charged violation is missing from the record. The prescriptions evidenced in P92 list a Florida address for Drs. Rosenkrantz and Rivera and a Missouri address for Dr. Thompson. It may be reasonable for the fact-finder to infer that the physicians are licensed in the state where they are located, but such an inference is less than clear and convincing. If Drs. Rosenkrantz and Rivera were licensed in Florida, Section 893.02(20) would impose no statutory duty on Gordon concerning their prescriptions. Dr. Thompson is not licensed in Florida. It is unclear that Dr. Thompson is licensed in a state other than Florida. Sufficient evidence of the statutory prerequisite to the charged violation is missing from the record. If it were found that Drs. Rosenkrantz, Rivera, and Thompson are licensed in a state other than Florida, the evidence is less than clear and convincing that Gordon failed to correctly apply the validity test prescribed in Section 893.02(20). Before employees of the pharmacy managed by Gordon dispensed any medications ordered by these physicians, the employees required each physician to sign a site fill list, or daily log, verifying the validity of the professional relationship, the authenticity of the prescription, and the medical necessity for the drugs. An unwritten agency statement prohibits Gordon from dispensing any controlled substance pursuant to a prescription transmitted by a physician who has not conducted an in-person examination of the patient. The unwritten agency statement requires Gordon to determine whether the physician has conducted an in-person examination regardless of the state in which the physician is licensed. It is clear from the record that Drs. Rosenkrantz, Rivera, and Thompson did not physically examine their patients prior to ordering the prescriptions evidenced in P92. Drs. Rosenkrantz, Rivera, and Thompson transmitted substantially all of the prescriptions evidenced in P92. The prescriptions list Florida addresses for Drs. Rosenkrantz and Rivera and a Missouri address for Dr. Thompson. The prescriptions are for patients located in more than 36 states and the District of Columbia. By negative proof, three prescribing physicians in Florida and Missouri could not have physically examined all of the patients in a single day. For purposes of continuity, further findings regarding the agency statement are made in the Conclusions of Law. Petitioner failed to prove the allegations in paragraphs 64 and 65 that Respondents engage in a fee splitting, commission, kickback, rebate, or split fee arrangement with USAP. Standards defining the prohibited arrangement are not defined clearly and convincingly. No evidence shows that Gordon receives anything from USAP or pays anything to USAP. Rx and USAP are located in the same building and maintain a business relationship. USAP pays Rx a fee for filling prescriptions plus any costs incurred by Rx. USAP pays Rx the costs of each prescription filled plus a fee of either $5 or $10 for each prescription. From October 19, 2001, through January 18, 2002, Rx filled approximately 66,217 prescriptions and billed USAP approximately $584,460 for fees, exclusive of costs. From January 25 through April 26, 2002, Rx filled approximately 88,556 prescriptions and billed USAP approximately $416,100 for fees, exclusive of costs. The evidence is less than clear and convincing that Rx paid any amount to USAP for referring patients to Rx or otherwise. The evidence is less than clear and convincing that USAP paid Rx for anything other than the costs incurred and services performed in filling prescriptions.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding Gordon not guilty of the allegations in the two administrative complaints against her; Rx guilty of violating Section 465.016(1)(i); imposing an administrative fine of $24,000 for the 24 instances of dispensing excessive quantities of controlled substances; placing Rx on probation for one year, subject to the condition that Rx utilize personal review or some other system adequate to prevent its employees from dispensing excessive quantities of controlled substances; and requiring Rx to pay the costs directly related to that part of the investigation and prosecution required to prove that Rx dispensed excessive quantities of controlled substances. DONE AND ENTERED this 10th day of January, 2003, in Tallahassee, Leon County, Florida. DANIEL MANRY 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 10th day of January, 2003. COPIES FURNISHED: Rosanna M. Catalano, Esquire David Herman, Esquire John Raymaker, Esquire Bureau of Practitioner Regulation - Legal Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Sean M. Ellsworth, Esquire Mark A. Dresnick, Esquire Monica L. Felder, Esquire Dresnick, Ellsworth & Felder, P.A. 201 Alhambra Circle Sun Trust Plaza, Suite 701 Coral Gables, Florida 33134-5108 John Taylor, R.Ph., Executive Director Board of Pharmacy Department of Health 4052 Bald Cypress Way, Bin C-04 Tallahassee, Florida 32399-1701 S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701
Findings Of Fact Respondent John E. Nichols is licensed by Petitioner and was in the private practice of dentistry in Marianna, Florida from 1975 to December, 1978. He attended undergraduate school at the University of Florida and, while there, saw a psychiatrist on several occasions for treatment of depression. He graduated from dental school at Western Reserve University in 1968 and thereafter served two years as a dentist in the United States Air Force in Okinawa. During this period, he visited an Air Force psychiatrist on a regular basis for treatment of depression, and upon discharge received a Veterans Administration service connected disability rating with diagnosis of anxiety reaction. In 1971, while employed as a private practitioner in Miami, Florida, he consulted and received treatment from a psychiatrist there for the complaint of depression. In 1972, he went to Marianna where he worked for three years in a boy's school prior to entry into private practice there. He had episodes of depression during his employment at the school and sought treatment at a guidance clinic in Marianna. In 1975 or 1976, Respondent sought treatment at the Oshner Clinic in New Orleans and psychiatrists there were of the opinion that his depression might be organic in nature. He has been under the treatment of Dr. John F. Mason, Jr., a psychiatrist in Panama City, Florida, since January, 1977 until the present date. (Testimony of Respondent, Mason (Deposition)) Respondent experienced difficulties with his marriage after going into private practice in Marianna, which led to a divorce in December, 1977. However, Respondent appealed the divorce decree and the matter was not finally settled until the latter part of 1978. He closed his office for approximately a six-month period prior to May, 1978. this time, Respondent was taking drugs prescribed by his psychiatrist which consisted of Valium and Parnate to treat his diagnosed conditions of schizophrenia and depression. Additionally, he was drinking alcoholic beverages to excess during this period due to difficulties in sleeping at night. (Testimony of Respondent, Mason) During the period May through December, 1978, there were a number of times when Respondent's employees cancelled appointments of patients due to his inability to perform dental services. A primary cause for such inability was Respondent's drinking alcoholic beverages the previous night with resulting intoxication. On such occasions, he would awaken in the morning feeling very depressed and unsure of himself. He would either notify his staff to cancel appointments or come to the office prepared to keep appointments, but be advised by his employees that he was in no condition to perform dental work. In such instances, he normally would not see patients. Sometimes he solicited employees' opinions as to his ability to work and other times they would volunteer such information to him. He appeared to be intoxicated at these times with a puffy face, lack of equilibrium, slurred speech, and red eyes. On one occasion, an employee smelled alcohol on his breath. Once he was observed by an employee coming to the office in the morning and staggering past a patient who was in the waiting room. Respondent had about forty child patients who were provided dental services through the auspices of the Department of Health and Rehabilitative Services. In 1978, he cancelled twelve appointments with HRS patients, ten of which were due to his mental or physical condition. These cancellations were normally made on the day of the appointment and thus caused inconvenience to HRS social workers who transported the children to and from their appointments. Although Respondent did not perform dental work on patients at times when he was intoxicated, he was observed by an employee on one occasion treating a patient when he "wasn't at himself" and didn't have "a straight chain of thought." (Testimony of Respondent, Adkins, Daffin, Welch, DeVane, Sellers, Respondent's Exhibits 1-2. (Respondent's Exhibit 2 was erroneously received in evidence at the hearing as Respondent's Exhibit 1. It has therefore been renumbered.)) In August, 1978, Respondent was at his home and received a call one evening from a male who stated that his female friend had a bad toothache. Respondent told him to bring her to his house and, when they arrived, he examined the girl, Sherry Ratner, and found her to have large decay in a tooth. Respondent suggested that he write a prescription for Demerol to alleviate the pain and that she make an appointment with his office on the next working day. The girl told him that she did not want anything that strong, but mentioned that she had previously taken Dilaudid which had been adequate for dental pain in the past. Respondent was unfamiliar with the drug, but determined through a reference work that it was an acceptable medication for pain relief. Respondent therefore gave her a prescription and the couple indicated that she would come into Respondent's office the next day. The couple came into Respondent's office on two subsequent occasions to obtain another prescription for Dilaudid and went into Respondent's back office without having a previous appointment or filling out a medical history statement. Later, a pharmacist called one of Respondent's employees and stated that he didn't carry the medication in as strong a dosage as shown on the prescription. Then queried by his employees concerning the matter, Respondent told them that the girl was coming in for an appointment the next day and they told him that she did not have an appointment. Respondent then said that she was on a drug rehabilitation program and that he wrote the prescription to keep her from obtaining the drug on the streets. Respondent testified that after he discovered that the girl was in a drug rehabilitative program in Kentucky, he felt that there was a problem in prescribing medication for her because she might have been using the drugs to "get high," and that he was further concerned that she had not made an appointment for dental care. (Testimony of Respondent, Adkins, Daffin, Cliff, Petitioner's Exhibit 3) On November 30, 1978, Respondent obtained thirty 100 mg Seconal tablets from a pharmacy by means of writing a prescription in the name of Shelta Jean Pacock, who was one of his patients in Marianna. On December 4, 1978, Respondent took over twenty of the tablets in a suicide attempt for which he was hospitalized for several weeks. Respondent testified that the suicide attempt was made because of his depressive state. He further testified that he wrote the Seconal prescription in someone else's name because he had been told by a local pharmacist that he could not prescribe drugs for himself. (Testimony of Respondent, Peacock, Petitioner's Exhibit 1) After release from hospitalization, Respondent closed his dental office and referred records of patients upon request to other dentists in the vicinity. He remarried in January, 1979, and, except for one instance in January or February, 1979, has not indulged in alcoholic beverages this year. His medication was changed by his psychiatrist and he is presently taking varying amounts of Elavil, Cogentin, Haldol and Antabuse. Respondent testified that he believes he does not presently have the self-confidence necessary to practice either by himself or with another dentist. He is of the opinion that after a few months he could resume practice, but would prefer to associate with another dentist who could help him at times when he felt insecure as a result of his illness. He is further of the opinion that the problems that he has experienced in the past psychologically can be eliminated by proper treatment and medication which will enhance his self-confidence. (Testimony of Respondent, M. Nichols.) Respondent's psychiatrist, Dr. John F. Mason, testified that throughout 1977-78, Respondent was at times very depressed and potentially suicidal, somewhat paranoid, and on occasion used alcohol to excess. He believes that Respondent's divorce was the precipitating cause for the depressive condition. Dr. Mason saw Respondent on "crisis consultation" a number of times and hospitalized him during acute episodes when he was suicidal until the period had passed. Since his suicide attempt in December, 1978, Respondent has been hospitalized only once, which occurred after he received a letter from Petitioner concerning licensing proceedings. He thereafter started drinking to excess and voluntarily hospitalized himself for treatment. At the present time, he is doing very well and his stable and supportive relationship with his present wife assists in providing strong elements of support to improve his prognosis to "reasonably good" for the future. Dr. Mason believes that Respondent should avoid the pressure of private practice which plays a part in his condition, by employment as a dentist in an institutional setting which would have a structured program. He diagnoses Respondent's condition as schizophrenia with depression as a complication of the basic elements. His condition is maintained on anti-psychotic drugs such as Stelazine, Haldol and Nalvane, and antidepressant drugs, including Elavil. He has not been psychotic while under treatment by Dr. Mason. Dr. Mason testified that Respondent's prior use of alcohol complicated the treatment of the depression, but he does not characterize him as an alcoholic because his use of alcohol was secondary to his psychiatric illness. At times during 1977-78, Respondent's medication was not properly balanced, causing some tremor of his hands and side effects as to concentration and memory. However, a puffy face, slurred speech, and bloodshot eyes are side effects of alcoholic beverages. (Testimony of Mason (Stipulated Admission of Deposition)) Several years ago, Respondent obtained counseling services concerning his alcohol problem with a fellow church member who was a former alcoholic and had worked in counseling programs. Several of Respondent's former patients and employees attested at the hearing to their belief that Respondent is a capable and considerate dentist. Respondent's wife testified that his present medication agrees with his system and that he has shown a tremendous improvement in his condition since December, 1978, and that he has gained more self- confidence during the past few months. (Testimony of Adkins, Daffin, Welch, Cheesborough, Gause, Conner, Wester, M. Nichols)
Recommendation That the Petitioner suspend Respondent's license to practice dentistry pursuant to the authority contained in Section 466.24(1) and (3)(a), Florida Statutes, under the conditions stated in paragraph 6 of the foregoing Conclusions of Law. DONE and ENTERED this 6th day of July, 1979, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings 101 Collins Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Armando Garcia and Joseph Boyd, Esquires 131 North Gadsden Street Post Office Box 1501 Tallahassee, Florida 32302 Dean Bunch, Esquire Ervin, Varn, Jacobs, Odom and Kitchen Post Office Box 1170 Tallahassee, Florida 32302 Florida State Board of Dentistry 2009 Apalachee Parkway Tallahassee, Florida 32301
Findings Of Fact Respondent's Exception A.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception A.2. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception B. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception C. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception D. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception E. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.2. is GRANTED. There is no competent substantial evidence in the record to support the finding, "It has nothing to do with thinness or girth of the Chinese people." Since the burden of proof is on the Petitioner, a lack of evidence by the Respondent on a point cannot be, itself, the basis for a finding of fact against Respondent. Respondent's Exception F.3. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.4. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.5. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.2. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.3. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.4. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exceptions H.1. through H.3. are REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.2. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.3. (first) is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.3. (second) through I.5. are REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception J.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception J.2. through J.3. are REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception J.4. is REJECTED for the reasons stated in the arguments of the Petitioner. RULINGS ON EXCEPTIONS TO CONCLUSIONS OF LAW Respondent's Exception A.1. is REJECTED on the basis that the Hearing Officer's analysis is correct. The Board is authorized and required to rule on federal laws and rules, as well as Florida Statutes, such as Chapter 499, which set forth the requirements that licensed medical doctors must meet but which are not within the Medical Practice Act, Chapter 458, Florida Statutes. This Exception is also REJECTED based on the reasons set forth in the Petitioner's argument. Respondent's Exception A.2. is REJECTED based on the written argument of the Petitioner. Respondent's Exception A.3. is REJECTED based on the Department's oral argument and its written arguments to Exceptions A.1. and A.3. to the conclusions of law. Respondent's Exception B.1. is REJECTED based on the arguments set forth by Petitioner. Respondent's Exception C.1. is REJECTED for the reasons stated in the oral argument by the Petitioner and the written argument by the Petitioner in response to Exceptions in C.1 in Exceptions to Findings of Fact and C.1. in Exceptions to Conclusions of Law. Respondent's Exception D. is REJECTED for the reasons set forth by the Petitioner. Respondent's Exception E. is REJECTED for the reasons set forth by the Petitioner. Respondent's Exception F.1. is REJECTED for the reasons set forth by the Petitioner. Petitioner's reliance on the Rodgers case is misplaced because that case involved full informed consent of the patients and did not involve fraud. Respondent's Exception F.2. through F.3. are REJECTED based on the reasons set forth by the Petitioner. Respondent's Exception G.1. is REJECTED for the reasons set forth by the Petitioner. Respondent's Exception set forth as "IV. SUMMARY" is REJECTED as cummulative. See Rule 21M-18.004, Florida Administrative Code. RESPONDENT'S EXCEPTION TO PENALTY 1. Respondent's Exception to penalty is REJECTED. PENALTY Upon a complete review of the record in this case, the Board determines that the penalty recommended by the Hearing Officer be ACCEPTED and ADOPTED. WHEREFORE, IT IS HEREBY ORDERED AND ADJUDGED that Respondent shall pay an administrative fine in the amount of $50,000.00 to the Executive Director within thirty days. Respondent's license to practice medicine in the State of Florida is SUSPENDED for a period of one year. Upon reinstatement from suspension, Respondent's license to practice medicine in the State of Florida is placed on PROBATION for a period of two years, subject to the special condition that Respondent pay $60,000.00 to the Department of Legal Affairs Division of General Legal Services, for use in consumer protection. This Order takes effect upon filing with the Clerk of the Department of Professional Regulation. DONE AND ORDERED this 17th day of August, 1989. BOARD OF MEDICINE FUAD S. ASHKAR, M.D. CHAIRMAN
Recommendation It is recommended that Dr. Willner be found guilty of ten counts of violation of the Medical Practice Act, that he be fined $50,000, and that his license be suspended for a period of one year, and that his licensure then be placed on probation for two years subject to the special condition that he pay $60,000 to the Department of Legal Affairs, Division of General Legal Services, for use in consumer protection. DONE and ORDERED this 7th day of June, 1989, in Tallahassee, Florida. WILLIAM R. DORSEY, JR. Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 7th day of June, 1989.
Findings Of Fact Respondent is a medical doctor, licensed to practice in Florida, and holds license number ME 0009310, issued by Petitioner. Respondent specializes in family practice and has been board certified by the American Academy of Family Physicians since 1974. Percodan is the manufacturer's brand name for oxycodone, which is a Schedule II controlled substance pursuant to Chapter 893, F.S. 2/ It is a drug used for the relief of pain, a synthetic analgesic, and is both a physically and psychologically dependent producing drug. It can cause drowsiness, urinary retention, nausea, vomiting, and interacts unfavorably with other sedative drugs, and is considered a depressant. On December 30, 1966, Evelyn Milstead, a 30 year old woman, came to Respondent's office complaining of nausea and a rash in her mouth. Respondent conducted a physical examination, took her medical history and thereafter prescribed tigan for the nausea. Ms. Milstead became a regular patient of Respondent's and he continued treating her for various ailments over a period of years. During the course of Respondent's treatment, Milstead developed a chronic urinary tract infection and kidney condition in which she passed kidney stones. On occasion Milstead was treated by Dr. Gillespie, a specialist in the field of urology for her kidney condition. In 1978, Respondent also referred instead to the Ochsner Clinic for evaluation of her urinary tract and kidney problems. She was evaluated at Ochsner Clinic and received prescriptions for darvocet, a pain medication, and keflex, an antibiotic, and was told that she would continue to have a chronic kidney problem. Over the years, Milstead was hospitalized several times by Dr. Gillespie for treatment of her kidney condition. The testimony of Dr. William H. Nass and Dr. Robert P. Johnson established that Respondent's initial prescriptions of percodan to Milstead were appropriate. However, Respondent's percodan prescriptions to Milstead eventually became inappropriate. Specifically, the prescriptions for 2,668 percodan tablets between August, 1980 and November, 1982, were established as excessive. On July 30, 1977, Bruce White, a 25 year old male, came to Respondent for medical treatment for headaches and thereafter returned to Respondent for treatment of various medical problems. Mr. White's wife, Vicki White, and their children were also seen by Respondent as their family doctor. On May 18, 1981, White came to Respondent complaining of neck and back pain from an automobile accident in which he also fractured his left lower leg. Respondent noted that White had been seen by a neurologist and an orthopedic surgeon for his head and leg. In addition to other medication, Respondent prescribed percodan to White for pain. White had also developed arthritis in his left leg, as a result of the car accident and fracture, and on one occasion was hospitalized for swelling of his left leg. Respondent referred White to Dr. Tippett, a neurosurgeon, concerning his headaches and to Dr. Graybiel, a rheumatologist, concerning his arthritis. However, White continued to see Respondent as his medical doctor because his work schedule on an offshore oil rig would only permit Saturday appointments with his doctor and Respondent's offices are open on Saturday mornings. White also found it difficult to pay the fees charged by specialists. Between May 8, 1981 and September 30, 1982, Respondent prescribed 780 percodan tablets for Bruce White. The testimony of Dr. Nass and Dr. Johnson established that Respondent's initial prescriptions of percodan to White were appropriate. However, the percodan prescriptions to White became inappropriate over time due to their excessiveness. The seriousness of this lapse is underscored by Respondent's failure to try other pain alleviating measures and failure to investigate abuse possibilities. On October 18, 1979, Vicki White, the wife of Bruce White, a 23 year old woman, came to Respondent's office seeking treatment. She complained of migraine headaches and stated that her father was in the hospital with cancer. She also stated that she had seen Dr. Eyser, a neurosurgeon, for her headaches. Respondent prescribed wygesic for her pain. She subsequently returned to Respondent for treatment of various complaints including chronic migraine headaches, colds, and a dislocated right shoulder. Initially, Respondent prescribed norcet for relief of this pain, and on July 31, 1981, first prescribed percodan for her migraine headaches. Respondent prescribed percodan on other occasions in response to her complaints of pain from migraine headaches and back strain. Respondent considered referring her to a neurologist for the headaches but White stated that she could not afford to see a specialist. Respondent prescribed 590 percodan tablets for Vicki White between July 31, 1981 and September 22, 1982. Percodan is an appropriate and acceptable medicine for the relief of migraine headaches, and Respondent's initial prescription of percodan to Ms. White was appropriate. However, his prescriptions became excessive over time since percodan is not to be used for long term treatment of migraine headaches. On September 7, 1982, M. D. Medlen, an Escambia County Deputy Sheriff, went to Respondent's office as an undercover police officer, under the assumed name of Donna Slay. She had been asked by Robert Powers, a narcotics officer with the Escambia County Sheriff's Department and Charles Deckard, an investigator with the Department of Professional Regulation, to go to Respondent's office in an undercover capacity and attempt to obtain a prescription for percodan. Medlen/Slay first gave general information to the receptionist, including identification, in the name of Donna Slay, chief complaint of a backache, previous illnesses, drug allergies, address, social security number, and insurance information. Medlen/Slay was shown to an examination room where her blood pressure and weight were taken by the nurse and a urinalysis was performed. Respondent then came in and asked Medlen/Slay what her problem was. She informed him that she had been pushed into a wall during a fight, and had injured her back. Respondent checked her pulse, did a range of motion test, and checked the alleged injured area by palpation. Each time Respondent pressed on the alleged injured area, Medlen/Slay told him it hurt. Respondent did not visually inspect the alleged injured area but asked Medlan/Slay if there was a bruise and she said no. In order to get the percodan, Medlen/Slay told Respondent that she had injured her back one other time and a doctor in Louisiana had prescribed percodan for that injury. Respondent asked how long ago Medlen/Slay had taken the percodan and she said one year ago. Respondent discussed the dangers of drug addiction with Medlan/Slay and then prescribed 20 tablets of percodan for pain and 30 tablets of indocin to reduce inflammation. Upon leaving Respondent's office, Medlen/Slay did not fill the prescriptions but turned them over to Deckard. Percodan is an acceptable medicine for back and shoulder pain. However, Respondent should have considered the possibility of fracture, visually examined the area to ascertain the presence of a hematoma (blood clot) and listened to the patient's chest to determine the presence of lung injury. Respondent did not perform an appropriate examination prior to prescribing percodan, and the prescription was therefore inappropriate. Respondent used poor judgment in his excessive prescriptions of percodan to the patients discussed herein. However, there is no evidence that Respondent prescribed the percodan for personal financial gain or that any patient was injured by Respondent's prescribing practices. The testimony of the expert witness established that the records maintained on these patients were inadequate. Frequently, the only notation for a given visit was the prescription for percodan, with no evaluation of the patient's condition. Further, Respondent's patient records did not even list all the percodan prescriptions issued. Thus, these records essentially reflect partial inventories of prescriptions issued, and do not justify the course of prescribing, which is important to the safe practice of medicine.
Recommendation Based on the foregoing, it is RECOMMENDED that Petitioner enter a final order placing Respondent on probation for a period of five years, require that Respondent practice under the supervision of another physician to be named by Petitioner during the initial year of his probation and that Petitioner restrict Respondent's license against prescribing Schedule II controlled substances while he is under such supervision. 4/ DONE and ENTERED this 24th day of April, 1984 in Tallahassee, Florida. R. T. CARPENTER, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of April, 1984.
Findings Of Fact Alexander G. Toth graduated from medical school in 1943 and migrated to Miami in 1948. He took his three-year residency in general surgery at the V. A. Hospital in Miami starting in 1951 and thereafter practiced general surgery until 1976 when he had a serious accident. This accident plus additional health problems caused him to give up surgery and he has practiced family medicine since 1976. His office hours have been limited from 9 until 12 each week day since 1976. Approximately 10 patients per day were seen by Respondent during the period involved in these charges. At all times here relevant Respondent was licensed by Petitioner as a physician. Richard Hatcher was a patient of Respondent in 1975 at which time he complained of headaches and low back pain. Respondent prescribed Percodan, Doriden, Dilaudid and Placidyl during a one-year period Hatcher was a regular patient. At this time Hatcher had a suit pending to recover damages for injuries received in an automobile collision. Hatcher did not see Respondent with any regularity again until 1978. Respondent's patient records of Hatcher (Exhibit 5) show he treated Hatcher on 11-20-78 on complaint of can't sleep, low back pain and spasm of lower back, by prescribing 100 Valium and 100 Percodan. Exhibit 6, which is a copy of prescriptions written by Respondent for Hatcher, shows the following prescriptions were written for Hatcher on dates indicated: 6/2/78 - 30 Valium 10 mg; 8/8/78 - 50 Seconal and 30 Fastin 30 mg; 10/11/78 60 Tuinal 3 grs, 60 Fastin 30 mg, 50 Valium 10 mg and 100 Percodan; and 11/20/78 - Valium 10 mg, 30 Fastin 30 mg and 100 Percodan. Exhibit 5 shows in 1975 Hatcher was 6 feet and 180 pounds. The entry dated 12/18/78 opposite Fastin is (Wt 205). During the period 12/18/78 to 2/27/79 Respondent prescribed for Hatcher on numerous prescriptions the following: 300 Percodan, 250 Valium, 230 Tuinal 3 gr, 60 Fastin, 60 Demerol 100 mg, one 30 cc vial Demerol 100 mg per cc, and 30 syringes (Exhibit 6) . Exhibit 5 contains an entry dated 3/2/79 "(Wants Demerol) Refused - refer to JMH", and a final entry (3-19) Deceased." Hatcher voiced the same or similar complaints of pain on each visit to Respondent. Richard Hatcher was found dead in his apartment on or about 21 March 1979 some 24 to 36 hours after he died. Cause of death was acute intravenous narcotism. The syringe with which the fatal narcotic was injected was still in his arm when his body was found. Due to the rapid clearing of many drugs from the blood the autopsy failed to reveal which of the opiate drugs caused Hatcher's death. About one week later Mrs. Hatcher, the mother of Richard, received from her ex-husband and father of Richard a page from a notebook found in Richard's apartment after his death signed by Richard which indicates some concern by Hatcher that he might overdose on drugs given him by Dr. Toth, the Respondent (Exhibit 12). Richard Hatcher became seriously involved with drugs in 1967 when he was 21 years old. By 1975 his mother noted a personality change where he would quickly go from normal to extremely agitated. In the fall of 1978 Hatcher committed himself to Village South, a drug rehabilitation program in Dade County, for some 4 or 5 months. After release from Village South Hatcher continued to take drugs. To his mother's knowledge he overdosed several times before his death. Three times she found him unconscious on the floor of her apartment and on numerous other occasions he was "spaced out". Respondent testified that Hatcher showed no indication he had abused or misused the medications Respondent prescribed. If so, it is evident that Respondent did not closely observe Hatcher or do more than hear his litany of pain. On the other hand, Exhibit 5 shows that some 2-1/2 weeks before Hatcher's death Respondent refused to prescribe the Demerol wanted by Hatcher. Unless Respondent recognized the seriousness of Hatcher's addiction it is not conceivable that he would suddenly refuse drugs so freely prescribed in the past. Michael Kavney was a patient of Respondent from June 1979 until his death from an overdose of Placidyl on 14 or 15 January 1980. On June 11 1979 Kavney complained of pain in his shoulder and Respondent prescribed 50 Tylenol. Kavney was 6 feet tall, weighed 189 pounds, and told Respondent he wanted to lose weight. Respondent on June 11, 1979 also prescribed 50 Fastin. On 8-16-79 Respondent, at Kavney's request, called in a prescription for 50 Valium. On 9/7/79 he called in a prescription for 50 Tylenol. Both of these prescriptions resulted from a phone call to Respondent. On October 29, 1979 Kavney visited Respondent, told him the shoulder pain persists and he would like some more weight reducers. By this time Kavney's weight was down to 185 pounds from 189 four months earlier. Respondent prescribed 50 Tylenol, 50 Valium (Exhibit 4) and 30 Fastin (Exhibit 3). By script dated 11/21/79 Respondent prescribed 50 Fastin for Kavney and by script dated 11/26/79 he prescribed 50 Tylenol (Exhibit 4). No record of these is contained in Exhibit 3. By entry on Exhibit 3 dated December 17, 1979 Respondent recorded "pain left shoulder, using heat at home, can't take codeine, Percodan 50". The Tylenol, which had been prescribed on four previous occasions, contains 1 grain of codeine per tablet. On January 14, 1980 Kavney visited Respondent, told him of disturbed sleep patterns, that he had taken Placidyl on prior occasions with good results and Respondent prescribed 60 Placidyl (750). Kavney was found dead in his automobile with an empty bottle with Placidyl label on the floor. An autopsy done on January 15, 1980 shows Kavney died from an overdose of Placidyl. Terry McGarey grew up in Miami and played in bands with Kavney as early as high school days. He had also known Hatcher since 1963. McGarey first visited Respondent in 1970 with an arm injury. He next saw Respondent near the end of 1976 and he complained of headache and leg pains from an earlier motorcycle accident. McGarey received a prescription for Percodan. McGarey, who appeared as a witness, testified that he had visited Respondent every three or four weeks in 1976 complaining of headache and during these visits he also received Placidyl, Demerol, Parest and Valium. These visits continued in 1977 with the same frequency and results. Respondent's patient records for Terrance McGarey (Exhibit 1) commence 3/28/78. The first entry is not dated but states "cc severe headaches - nausea - at JMH March `78. Neuological dept. - treated for organic brain syndrome - at JMH 1976 migraine - no allergies - only relief Demerol. Rx demerol 100 mg #5 fiorinal tabs." Thereafter Exhibit 1 shows entries 7-31-78, 8-7-78, 8-28, 9-1, 9-6, 9-11, 9-27, 10-9, 10-20, 10-29, 10-31, 11-16, 11-22, 12-18, 12-22, 12-29, 1-3, 1-8, 3-21 and 4-19-79. Most of these entries resulted from office visits but some entries recorded prescriptions as a result of phone calls. During this period prescriptions were issued to McGarey for Percodan, Emperin, Doriden Parest, Tuinal, Demerol, Placidyl, Dalmane, Darvon, Seconal and Valium (Exhibit 2) On May 7, 1979 McGarey called the Cardella Pharmacy saying he was Dr. Toth, gave the correct DEA number and authorized the delivery of 18 Placidyl 50 mg to patient Jerry McGaret. The pharmacist called the doctor's office, which was closed, and then issued the drugs to McGarey. A subsequent try was unsuccessful when the pharmacist was told by Respondent's office that this man was no longer a patient of Respondent. Respondent testified that he treated McGarey for migraine headaches, insomnia, nervousness, and low back pain. He found no evidence of abnormal conditions in his examination of McGarey. Through mid-October Respondent had no indication McGarey was in a methadone program or addicted and the drugs were continued with each visit or phone call. On December 29 Respondent learned from McGarey that he had been admitted to JMH for seizures and the resident recommended Seconal. On this basis Respondent prescribed Seconal but did not learn the cause of the seizures. On January 8, 1979 McGarey's mother called Respondent to advise that her son was a drug abuser and had been on a methadone program for 18 months. Following this entry is the notation "No more Rx's - back to JMH". Respondent's next entry on Exhibit 1 is "Called records at JMH patient admitted 2-9-79 - overdosed - discharged 2-14 Signed out - mother took him home." Although Respondent testified it never entered his mind that McGarey might be a drug abuser he also testified that the symptoms of narcotic addiction are agitation, nervousness, slurred speech and poor equilibrium. On the witness stand McGarey exhibited traits of nervousness and agitation. He appeared hyperactive rather than calm and sedate. His movements were jerky rather than fluid and he did not give the impression of a normally relaxed person under tension because he was testifying. On 11 January 1980 Kirk Kratz, a 29-year-old male, visited Respondent's office as a patient. He had a cast on his right upper arm and stated it was fractured some two weeks earlier. Also he had received a gunshot wound in the abdomen before Christmas and a laparotomy had been performed. He complained of pain in the right arm. He was given a prescription for 100 Percodan for pain and 60 Tuinal 3 gr for sleep. Kratz returned 12 February with same complaints and was given prescriptions for 100 Percodan, 60 Tuinal and 30 Valium. On 2/29 Kraft appeared without the cast, told Respondent the police had broken the cast, held him in jail for 3 days and confiscated his medication. He was given prescriptions for 100 Percodan and 60 Tuinal. On 4/8/80 Kratz still complained of "pain in the shoulder and arm and can't sleep." Prescriptions for 100 Percodan, 60 Tuinal and 100 Valium were given him. Finally on 6/13, with complaint of pain in hand and shoulder, Kratz was given prescriptions for 100 Percodan and 30 Doriden (Exhibit 9). Hatcher and McGarey were drug addicts before and during the time they were being treated by Respondent. At one time or another both of them had been enrolled in the methadone program at Jackson Memorial Hospital and/or other withdrawal programs for addicts. In addition to getting drugs from Respondent, they were also obtaining drug prescriptions from other doctors. Also from the quantity of drugs prescribed for Kavney and Kratz it is evident that both of these individuals were also addicts. During the period between 1 January 1980 and 14 June 1980 Respondent, with an active practice of some 700 patients prescribed approximately 28,000 Percodan and 2,000 Percocet tablets to various patients. Exhibit 16 shows a breakdown of the 130 patients treated by Respondent during this period. While Exhibit 16 shows Kirk Kratz received 100 Percodan only on 2/29/80, Exhibit 8 indicates he received 500 Percodan between 1 January and 14 June 1980. Assuming all other entries on Exhibit 16 to be accurate, a spot check shows the following patients were given Percodan or Percocet during the period 1 January - 14 June in the following quantities: Steven Arnold - 300; Cathy Blauk - 450; Bill Davis - 500; Kirk Decker - 300; George Fernandez - 300; Sidney Ford - 600; Ron Jangie - 300; Jerome Johnson - 300; Patty La Fortuna - 310; Vincent La Fortuna - 200; William Leonard - 350; Mary Leslie - 300; Gus Melquezo - 400; Michael Pravioski - 225; Debbie Saey - 250; Robert Sandifer - 400; James Setters - 300; Alvin Terrell - 300; Mike Thill - 300; Mark Wolfson - 200; Joe Worth - 300; and Harvey Zemaster - 200. Exhibit 16 also shows that most of these prescriptions were written for quantities of 100. It also lists almost 18,000 Percodan issued to 130 patients during this period, or an average of 140 per patient. Percodan, Tuinal, Parest, Demerol and Seconal are Class II drugs. One hundred Percodan taken in a one-month period will cause addiction in the taker. After 48 hours taking Percodan every 4 to 6 hours the patient will have withdrawal symptoms. Although Placidyl, Valium, Doriden, Empirin and Dalmane are not Class II drugs, they are dangerous and therefore controlled. Fifteen Placidyls taken at one time can be fatal. Many of the drugs prescribed by Respondent, when taken in combination, create a synergistic effect which makes the combination greater than the sum of its parts. Similarly a synergistic effect is created when some of these drugs are taken in conjunction with alcohol. Fastin is used for weight control. Neither Hatcher nor Kavney at 6 feet and 180 - 185 pounds should have been a candidate for weight loss. Further, prescriptions for Fastin and Seconal (for sleep) at the same time are incompatible as one is an upper, the other a downer. Tuinal in combination with Valium will increase depression. When Fastin is added, a pharmacological jungle can result. Respondent acknowledged that he relied more on the statements of his patients than upon an examination to determine when to prescribe medications. If the patient said he hurt, Respondent would prescribe a pain killer. A two- week-old fracture properly set and in a cast should cause little pain. If pain persists two weeks after casting something is wrong that will not likely heal itself. Therefore, painkillers to mask the symptoms are contraindicated. Similarly, a persistent pain in the shoulder is likely to be caused by inflammation and an anti-flammatory agent is indicated. Neither Tylenol nor Percodan are anti-inflammatory agents. Dr. John V. Handwerker, M.D. was accepted as an expert in family practice medicine. After reviewing Respondent's records of Hatcher, Kavney, Kratz and McGarey he expressed the strong opinion that the complaints of the patients did not justify the narcotics prescribed; that much larger quantities of each drug were prescribed at one time than was medically indicated or prudent; that drugs were prescribed in dangerous combinations due to the synergistic effect if taken together, plus some of these drugs such as Fastin and Valium are mutually exclusive; that issuing a prescription to take these drugs "as needed" was improper and dangerous; and that narcotics were frequently prescribed for alleged ailments for which more effective non-narcotic drugs were available. This witness was particularly critical of the prescription for liquid Demerol, as this should be prescribed only when the patient can't take the drug orally. After reviewing Exhibit 7 Dr. Handwerker expressed the opinion that prescribing 28,000 Percodan tablets during a 5-1/2 month period could only be justified with a large practice limited to trauma patients and that the records and prescription schedules show a practice harmful to the public. This opinion was based partially on Dr. Handwerker's practice in which, during the same period, he saw 2,081 patients and wrote 73 prescriptions for 1,996 Percodan tablets. Exhibit 7 contains 291 prescriptions issued by Respondent during this period, and recovered by Petitioner's investigator from pharmacies in the vicinity of Respondent's office. These coupled with Respondent's patient records show some 28,000 Percodan and 2000 Percocet tablets were prescribed. Valium is the most commonly prescribed drug in the United States and one of the most abused drugs. If a patient is emotionally stable 60 Valium is too many to prescribe for a patient at one time. If a patient is emotionally disturbed there is even greater reason for not prescribing 60 Valium. Dr. Roderick Palmer, M.D., testified as an expert in clinical pharmacology. He opined that prescribing 100 Percodan for a patient at one time was not appropriate because if the pain results from a traumatic injury, such injury will normally cease being painful in 4 or 5 days, and 100 Percodan is enough to commit suicide or become addicted. Dr. Palmer described Percodan and Placidyl as widely abused drugs. Sixty Placidyl in one prescription is too many because of suicide potential. Further, if one Placidyl is taken every day for 60 days the patient would probably become addicted. Taking more than one Placidyl per day could impair coordination enough to result in an industrial or automobile accident or other injury. With respect to Exhibit 7, Dr. Palmer cited instructions for Percodan or Percocet that the physician should not prescribe enough to result in addiction (not more than 30) nor prescribe enough for patient to commit suicide. It is necessary for patients to return to the physician before the patient can become addicted to the drugs prescribed. In this way the doctor will not lose control over the patient which could result in the patient becoming addicted. With respect to the 28,000 Percodan prescribed in a 5-1/2 months period Dr. Palmer viewed that quantity as more than he would prescribe in a lifetime. Dr. Murray Sims, M.D., is a Board certified surgeon who testified on behalf of Respondent. He found the prescriptions issued to Hatcher, Kavney, McGarey and Kratz to be proper for the complaints of the patients. Sims has known Respondent for many years, and has worked, studied, and taken examinations with Respondent. Dr. Sims prescribes Percodan in quantities of 100 and even 200. He does not believe 100 Percodan taken in a 30-day period is addictive. He has one 93-year old patient to whom he mails prescriptions for 100 Percodan per month (40 to 60 days) because, as she told him, "It makes my day start off right." (Tr. Vol. II, p. 102). When asked if Percodan and Tuinal taken together would have a synergistic effect Dr. Sims said no (Tr. Vol. II, p. 67) but on p. 119 he testified "I guess it would, you get a relief of both, yes. Don't hold me too much about pharmacy." Dr. Sims practice is 99 percent devoted to surgery patients and if he has a patient with a non-surgical related disorder he usually refers the patient to another doctor. This witness's testimony regarding the various drugs prescribed by Respondent and the appropriateness thereof was not deemed as credible as was the testimony of Drs. Hardwerker and Palmer. This was so because the latter had more expertise in this area of medicine and demonstrated greater credibility on the witness stand.
