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
The Issue Whether Shady Rest Care Pavilion, Inc. failed to maintain the nutritional status of one of its residents so as to justify the imposition of a conditional license rating upon the facility and an administrative fine of $2,500.
Findings Of Fact Based upon the testimony and evidence received at the hearing and the parties' stipulations, the following findings are made: Shady Rest is licensed by the Agency as a skilled nursing facility. Shady Rest's license number is SNF1497096. The Agency conducted an on-site survey of Shady Rest from July 30, 2001, to August 2, 2001. At the time of the survey, Shady Rest's licensure status was standard. The survey was conducted by a "team" that included dietitian Lori Riddle and other health care professionals. The survey team identified several deficiencies at the facility. The deficiencies were detailed on the Form 2567 which was provided to Shady Rest by the Agency. The only deficiency still at issue in this proceeding is the Tag F325 which was summarized on the Form 2567 as follows: Based on observations, clinical record review and staff interviews, the facility failed to ensure that nutritional needs were met for 3 (Residents 11, 21 and 22) of 5 active sampled residents receiving tube feeding who were at high risk for malnutrition as evidenced by significant weight loss, low albumin and total protein levels and recurring pressure sores. The survey team classified the Tag F325 at Level "G" (i.e., isolated actual harm) on the federal scope and severity matrix, which corresponds to an isolated Class II deficiency under the Florida classification scheme. Based upon the cited Class II deficiency, the Agency issued a notice of intent to change Shady Rest's licensure status from standard to conditional, and the Agency initiated a separate action to impose an administrative fine upon Shady Rest. This proceeding followed. At the hearing, the Agency narrowed the focus of the alleged deficiency from the three residents identified on the Form 2567 to only one, Resident 11. No evidence or testimony was presented regarding any other residents. Resident 11 is a female. At the time of the survey, she was 89 years old, 64 inches (five feet, four inches) tall, and weighed 145 pounds. She has been at Shady Rest since 1987. A care plan for Resident 11 was developed by a "team" that included the director of nursing at Shady Rest, a nurse (Sonja Reece, R.N.), a dietitian (Ann Marie Shields, R.D.), two care plan coordinators, and social service and activity personnel. Members of the care plan team worked closely with Resident 11's physician, Dr. Lakshmi Bushan, to manage Resident 11's medical conditions. Dr. Bushan was actively involved with the care of Resident 11 and was very familiar with her conditions. Dr. Bushan was at the facility on a weekly basis and sometimes several times per week. Resident 11 is totally dependent on Shady Rest and its staff for the provision of nutrition. She is fed through a tube connected directly to her stomach. Resident 11 is a "very complex resident" as a result of a myriad of serious medical conditions, including heart attack, seizure disorder, edema (i.e., swelling of the tissues due to fluid retention), hiatal hernia with reflux, pemphagus (i.e., an autoimmune disease resulting in blisters around the body), congestion in the lungs which caused breathing problems, kidney disease, and liver problems. She was also prone to skin breakdown. The treatment of Resident 11 was complicated by the fact that management of one of her conditions would exacerbate another. For example, the Prednisone she was taking to treat her pemphagus increased her fluid retention and, hence, her edema; but, Lasix, the diuretic she was taking for the edema, caused her to have diarrhea which led to the breakdown of her skin from constant cleaning and put her at risk of dehydration and kidney failure. Resident 11's edema was at a dangerous level, referred to as "3+ pitting edema." Relieving the edema was determined to be of critical importance to Resident 11 by her physician. The fluid retention in Resident 11's lungs caused her to suffer from shortness of breath which could ultimately lead to congestive heart failure. Because Resident 11 did not respond well to Lasix and because it actually exacerbated her other medical problems (i.e., skin breakdown), a fluid reduction diet was deemed necessary by her physician. Resident 11 was overweight, partially due to her edema. Resident 11's weight contributed to and exacerbated her medical conditions, particularly her congestion and breathing problems, and it enhanced her risk of congestive heart failure. On April 3, 2001, Dr. Bushan ordered an evaluation of Resident 11's nutritional status and the adequacy of her tube feeding. Resident 11 weighed 163 pounds on that date. On April 4, 2001, Ms. Shields, performed the evaluation ordered by Dr. Bushan. Ms. Shields calculated the total calories per day (cal/day) needed by Resident 11 based upon a standard formula. She then subtracted 400 cal/day to take into account the weight loss desired by Dr. Bushan. Ms. Shields' calculation resulted in an estimated caloric need for Resident 11 of 1,100 to 1,200 cal/day. Because the feeding ordered at that time provided 1,125 cal/day, which was within the range computed by Ms. Shields, no changes were made to Resident 11's diet at that time. Resident 11 was, however, taken off Lasix at that time because it was not contributing significantly to her weight loss and it was putting her at risk for dehydration and kidney failure. Resident 11's weight dropped only slightly after the April 4, 2001, evaluation. On May 1, 2001, she weighed 159 pounds and on June 1, 2001, she weighed 158 pounds. Dr. Bushan wanted Resident 11 to lose more weight more rapidly to stabilize her serious medical conditions. Accordingly, on June 13, 2001, Dr. Bushan requested a dietary consultant to check the amount of Resident 11's tube feedings in order to implement a planned weight loss program to reduce Resident 11's weight to 145 to 150 pounds. Ms. Shields conducted the assessment on June 14, 2001, and after consulting with Resident 11's care plan team, she recommended to Dr. Bushan that Resident 11's caloric intake be reduced from 1,125 cal/day to 750 cal/day to accomplish the rapid and significant weight loss desired by Dr. Bushan. Dr. Bushan accepted Ms. Shield's recommendations and ordered the reduction in calories on June 14, 2001. On that date, Resident 11 weighed 158 pounds. Resident 11's care plan was updated on June 14, 2001, to reflect the goal of reducing her weight by not more than five pounds per week until she reached less than or equal to 150 pounds. The dietary change achieved the desired effect of rapidly reducing Resident 11's weight and stabilizing her medical conditions. Her weight records showed the following: Date June 20, 2001 Weight 153 June 27, 2001 153 July 4, 2001 152 July 11, 2001 153 July 18, 2001 152 July 25, 2001 n/a August 2, 2001 145 The dietary notes for August 1, 2001, indicate that Resident 11's "weight goal was met" and recommended a dietary change to increase Resident 11's caloric intake to 1,000 cal/day. The record does not include the doctor's order implementing that recommendation. However, by August 8, 2001, Resident 11's weight was at 151 pounds, suggesting that the dietary change was implemented. Between the June 14, 2001, dietary change and the August 2, 2001, survey, Resident 11 lost 13 pounds, which is an 8.2 percent weight loss. For the three-month period of May 1, 2001 through August 2, 2001, Resident 11 lost 14 pounds, which is an 8.8 percent weight loss. Resident 11's edema improved significantly during this period; it was no longer at the "3+ pitting edema" level. In this regard, some of Resident 11's weight loss is attributable to the elimination of retained fluids (i.e., reduction in her edema), which was a significant purpose of the weight loss program. The amount of the weight loss attributable to the fluid loss is not quantifiable. The federal guidelines discussing Tag F325, which the Agency's survey team uses in its evaluation of a facility, state that "weight loss (or gain) is a guide in determining nutritional status" and identify parameters to be used in evaluating the significance or severity of weight loss. The 8.8 percent weight loss experienced by Resident 11 over a three- month period would be considered "severe" based upon the parameters. The parameters in the federal guidelines specifically refer to "unplanned and undesired weight loss." By contrast, the weight loss experienced by Resident 11 was planned and desirable. It was directed by Dr. Bushan after Ms. Shield's dietary consultation in order to reduce Resident 11's fluid intake and her edema while also promoting rapid weight loss to minimize her congestion and related breathing problems. The estimated protein needs for Resident 11 were 53 to 57 grams per day. The protein that she was being given, both prior to and after the June 14, 2001, dietary change was within that range. Increasing Resident 11's protein to offset the calorie reduction was not considered a viable option for Resident 11 because her history showed that the more protein she received the more weight she gained. Moreover, too much protein could cause liver failure, which was a risk for Resident 11. When the body is not receiving enough calories, it can metabolize protein as a calorie source rather than for the purposes protein is normally used, such as health of the skin. Resident 11 experienced skin breakdown (i.e., pressure sores or decubitus ulcers) after the June 14, 2001, dietary change. The sores were very small in size and, consistent with Resident 11's past history, the sores healed quickly. Therefore, they are not indicative of a protein deficiency. Indeed, subsequent to the dietary change, Resident 11's skin turgor was good. The laboratory reports for Resident 11 showed her having low albumin levels after the dietary change. Low albumin is generally an indicator of insufficient protein in the body. However, as noted above, the rate at which Resident 11's skin healed suggests that she was getting sufficient protein. Resident 11's low albumin level, in and of itself, is not determinative of her nutritional status. Indeed, the federal guidelines provided to the survey team state: Because some healthy elderly people have abnormal laboratory values, and because abnormal values can be expected in some disease processes, do not expect laboratory values to be within normal ranges for all residents. Consider abnormal values in conjunction with the resident's clinical condition and baseline abnormal values. Even before the June 14, 2001, dietary change, Resident 11's albumin level was not within the normal range. Her abnormal albumin levels may have been the result of her liver problems. Dr. Bushan and the care plan team at Shady Rest managed Resident 11's care based upon their clinical observations of her in conjunction with their experience regarding what worked for her in the past, not simply based upon her laboratory values. They were constantly weighing standards of practice with what was actually happening with Resident 11.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration issue a final order which: Dismisses the Administrative Complaint against Shady Rest Care Pavilion in DOAH Case No. 02-1291; and Rescinds the notice of intent to assign conditional licensure status to Shady Rest Care Pavilion in DOAH Case No. 02-1965 and retains the facility's standard licensure status. DONE AND ENTERED this 26th day of August, 2002, in Tallahassee, Leon County, Florida. T. KENT WETHERELL, II 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 26th day of August, 2002.
Findings Of Fact At all times material, Respondent, Michael J. Warhola, D.O. (Warhola), was licensed as an osteopathic physician, license number 05 0001256, issued by the State of Florida. At all times material, Warhola was in general practice in Tampa, Florida. A large part of Respondent's practice consisted of patients wishing to lose or control weight. PATIENT CURTIS HANCOCK Between on or about September 25, 1984 and on or about June 10, 1985, Respondent treated patient Curtis Hancock for weight control primarily. On the first visit, a patient history was obtained from Hancock. The patient history was adequate for a weight control patient such as Hancock except that it did not include a detailed record as to the length of time Hancock has experienced the weight problem, what diet medications Hancock had taken, what kind of weight loss program Hancock had been involved in and the history of recent weight loss or gain and diet. On Hancock's first visit, Warhola also had Hancock's blood pressure, weight and pulse taken. Additionally, Hancock's age and height were recorded. Respondent did not listen to (auscultate) Hancock's heart sounds but did, and reviewed, an electrocardiogram. These physical examinations and other testing performed on Hancock on the first visit were inadequate for a patient such as Hancock only in that Warhola did not examine and palpate Hancock's neck (for thyroid abnormalities). One of the tests Warhola had performed on Hancock on September 25, 1984, was a SMAC 26 comprehensive blood test which includes T3, T4 and T7 studies. Those test results and the rest of the examination revealed no abnormalities in Hancock's thyroid function or metabolic function. On or about the first office visit, Respondent provided Hancock with literature about diet. The literature contained a recommendation that the patient abstain from alcohol and sugar intake. But Respondent did not attempt to treat Hancock by diet and exercise alone first. Respondent generally makes the presumption that by the time a patient comes to him for weight control the patient has tried an assortment of diet regimens, possibly supplemented by exercise and over-the-counter diet medications. He presumes that what the patient wants and needs in order to accomplish weight loss or weight control is prescription diet drugs. On the first visit on September 25, 1984, Warhola prescribed and dispensed to Hancock the following drugs: DRUG QUANTITY Multi Vitamin 28 Phentermine 8 mg. 56 Phendimetrazine 35 mg. 56 Promethazine HCL 12.5 mg. 28 On each subsequent office visit Warhola had his office staff take Hancock's blood pressure, weight and pulse rate. At no time during his treatment of Hancock did Respondent listen to Hancock's heart sounds. No additional electrocardiograms of Hancock were taken after the initial visit. Respondent performed no other physical examination of Hancock on any of the subsequent office visits. Between October 23, 1984 and June 10, 1985, Respondent prescribed and dispensed for Hancock the following drugs: DATE MEDICATION QUANTITY 10/23/84 Multi Vitamin 28 Thyroid 1 gr. 28 Ferrous Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Prcmetharine HCL 12.5 mg. 28 11/20/84 Multi Vitamin 28 Thyroid 1 gr. 28 Ferrous Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Phentermine 8 mg. 112 Promethazine HCL 12.5 mg. 28 12/11/84 Thyroid 1 gr. 28 Ferrcus Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Promethazine HCL 12.5 Bran Fiber mg. 28 01/24/85 Multi Vitamin 28 Levo Thyroid 0.1 mg. 28 Ferrcus Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Promethazine HCL 12.5 mg. 28 Fastamine 112 02/01/85 Multi Vitamin 28 Levo Thyroid 0.1 mg. 28 Ferrous Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Promethazine HCL 12.5 mg. 28 Fastamine 112 Vistaril 50 mg. 28 03/14/85 Multi Vitamin 56 Levo Thyroid 0.1 mg. 56 Ferrous Gluconate 56 Phentermine 30 mg. 224 Phendimetrazine 35 mg. 224 Promethazine HCL 12.5 mg. 56 Vistaril 50 mg. 56 Hyosophen - 224 (Belladonna Alkaloids w/ Phenobarbital) Hydrochlorothiazide 50 mg. 56 w/Reserpine 0.25 mg. 04/30/85 Multi Vitamin 56 Levo Thyroid 0.1 mg. 56 Ferrous Gluconate 56 Phentermine 30 mg. 224 Phendimetrazine 35 mg. 224 Promethazine HCL 12.5 mg. 56 Vistaril 50 mg. 56 Hyosophen 224 (Belladonna Alkaloids w/ Phenobarbital) Hydrochlorothiazide 50 mg. 56 w/ Reserpine 0.25 mg. 06/10/85 Multi Vitamin 56 Levo Thyroid 0.1 mg. 56 Ferrous Gluconate 56 Phentermine 30 mg. 224 Phendimetrazine 35 mg. 224 Promethazine HCL 12.5 mg. 56 Vistaril 50 mg. 56 Hyosophen 224 (Belladonna Alkaloids w/ Phenobarbital) Hydrochlorothiazide 50 mg. 56 w/ Reserpine 0.25 mg. The labels for the drugs identified in the immediately preceding paragraph did not contain the name of the drugs dispensed. Hancock did not ask, and Respondent did not verbally advise Hancock of, the names of the drugs which Respondent dispensed or caused to be dispensed to Hancock. Phentermine 8 mg. and 30 mg. and phendimetrazine 35 mg. are sympathomimetic amines. Phendimetrazine is a schedule III controlled substance, under Section 893.03, Florida Statutes. Phentermine is a schedule IV controlled substance, under Section 893.03, Florida Statutes. Tolerance to the anorectic affects of both of these drugs usually develops within a few weeks. When this occurs, the recommended dose usually should not be exceeded in an attempt to increase the effect; rather, the drugs should be discontinued. One of the notable contra-indications of both of these drugs is elevated blood pressure (moderate and severe hypertension, any diastolic value of 100 or higher). Manifestations of chronic intoxication with anorectic drugs (like phentermine and phendimetrazine) include marked insomnia, irritability, hyperactivity and personality changes. Promethazine HCL is a sleep medication. Thyroid and Levo Thyroid are both thyroid medications which are indicated for use where hypothyroidism exists. Both drugs are metabolic stimulants given to compensate for decreased thyroid function. If either of these medications is administered to an individual who had a normal thyroid function or euthyroidism, the drugs would cause the individual to experience hyperthyroidism, or an increased metabolic condition, and the possibility of serious side effects. Fastamine is the brand name for a drug containing benzocaine and is used to curb appetite by numbing the stomach. Vistaril is a depressant which can function as an anti-anxiety agent. Hydrochlorothiazide 50 mg. is a diuretic which was dispensed by Respondent in a compound form which also contained Reserpine 0.25 mg. Reserpine is a drug that will cause an initial stimulation, like epinephrine, followed by a secondary effect of depression. Hydrocholorthiazide 50 mg. with reserpine 0.25 mg. is used as a diuretic and an anti-hypertensive agent. It is generally accepted that thyroid medications, such as Thyroid, Levo Thyroid and a drug named Cytomel (which is similar in action to the other thyroid medications), should not be prescribed, dispensed, or ordered with sympathomimetic amines. The combination of thyroid medications and sympathomimetic amines, when dispensed or prescribed to be taken together, can be very dangerous and can potentially result in cardiovascular shock. Unless caused by hypothyroidism, obesity is not an acceptable indication for thyroid hormone therapy. A review of Respondent's records for patient Hancock reveals that between September 25 and December 11, 1984, Hancock lost 12 1/2 pounds. Between January 24 and February 1, 1985, Hancock gained 4 1/2 pounds. Between February 1 and April 30, 1985, Hancock lost 11 1/2 pounds. Between April 30 and June 10, 1985, Hancock gained 6 1/2 pounds. Respondent's records reflect Hancock's starting weight was 213 1/2 pounds. On the date of Hancock's last visit, almost ten months after the patient's first visit, Hancock weighed 200 1/2 pounds with a total weight loss of only 13 pounds. A review of Respondent's records for patient Hancock reveals that Hancock's blood pressure was 120/84 on September 25, 1984; 120/84 on October 23, 1984; 122/80 on November 20, 1984; 120/84 on December 11, 1984; 130/90 on January 24, 1985; 140/100 on February 21, 1985; 150/100 on March 14, 1985; 144/90 on April 30, 1985; and 130/80 on June 10', 1985. In an otherwise healthy adult, any diastolic (the second of the two numbers in a blood pressure reading) value of 90 or greater for an extended period of time is considered mild hypertension. A diastolic value of 100 or greater is considered serious hypertension. Despite the fact that the diastolic value of Hancock's blood pressure readings was 90 or higher between January 24, 1985 and April 30, 1985, Respondent did not reduce or eliminate the number of sympathomimetic amines and thyroid medications dispensed to patient Hancock. Respondent responded to the elevated blood pressure readings found in Hancock by adding an anti-hypertensive agent to the existing regimen of drugs. He hypothesized that the elevated blood pressure was a result of marital problems Hancock told him he was having. On March 14, 1985, April 30, 1985, and June 10, 1985, Respondent dispensed what was supposed to be a two months supply of the above-listed drugs. On April 30, 1985, Hancock returned for more medications after 46 days; and on June 10, 1985, Hancock returned for medications after only 40 days. Nonetheless, Respondent dispensed more medications on each occasion. Respondent's records indicate that on April 30, 1985, a two month supply was dispensed because the Respondent was going on vacation. Respondent told Ms. Gazverde during the course of an interview that if a patient returned earlier than scheduled, refills would be refused until the scheduled visit or proof of loss of medication was provided. But, if this was Respondent's policy, it was not followed in Hancock's case. Respondent inappropriately and excessively dispensed phentermine, phendimetrazine and thyroid medications, including Thyroid and Levo Thyroid, to patient Hancock in that: The phentermine and phendimetrazine were prescribed and dispensed in excessive dosages and for an excessive length of time; The phentermine and phendimetrazine were prescribed and dispensed in combination (and in excessive dosages); Thyroid medications were prescribed although Hancock's thyroid was normal; Thyroid medications were prescribed to be taken in combination with the phentermine and phendimetrazine; Respondent continued to prescribe phentermine, phendimetrozi and thyroid medications to Hancock despite moderate to severe hypertension (140/100 on 2/21/85 and 150/100 on 3/14/85); Respondent twice dispensed more drugs than he had prescribed for Hancock without requiring Hancock to account for the missing drugs; and Respondent made no effort to treat Hancock without drugs as first line of treatment. Respondent failed to practice osteopathic medicine with acceptable levels of care, skill and treatment for the reasons listed in paragraph 23, above, and because Respondent did not examine or palpate Hancock's neck for thyroid abnormalities on any visit and neither did an electrocardiogram nor listened to Hancock's heart sounds on follow-up visits. In addition to the matters set out in the two immediately preceding paragraphs, Respondent's records for patient Hancock were not adequate to justify Respondent's treatment of Hancock in that no information was recorded as to the length of time the patient had experienced a weight problem; what diet medications Hancock had taken; what kind of weight loss program Hancock had been involved in; and a history of recent weight loss or gain and diet. A reasonably prudent osteopathic physician, in obtaining a patient history for weight control purposes, would question the patient as to their normal weight, determine past techniques utilized for weight control (including medication, diet and exercise), and ascertain recent weight history and length of time the weight problem has existed. The information should be in the patient record. Additionally, a reasonably prudent physician, in examining a patient for weight control purposes, would perform a physical examination including, at a minimum, examination and palpation of the neck and auscultation of the heart. Alternatively, an electrocardiogram serves the purpose of auscultation of the heart. Respondent did not examine or palpate patient Hancock's neck. Furthermore, Respondent did not listen to patient Hancock's heart sounds. Respondent did and reviewed an electrocardiogram on Hancock's first visit but not on his follow-up visits. PATIENT HOPE ECHEZABAL Between on or about November 3, 1971 and April 21, 1984, Warhola intermittently treated patient Hope Echezabal for weight control. On Echezabal's first visit, Warhola took an adequate patient history of Echezabal except, like Hancock, the patient history does not record detailed information as to the length of time the patient had experienced a weight problem, what diet medications Echezabal had taken, what kind of weight loss program Echezabal had been involved in, or a history of recent weight loss or gain and diet. The patient history indicated normal menstruation. On Echezabal's first visit to Respondent's office, Respondent performed an inadequate physical examination only in that no pulse rate was taken and Warhola did not examine or palpate the patient's neck. Respondent also did not listen to Echezabal's heart sounds, but Warhola did have an electrocardiogram done on Echezabal. The testing did include testing with an achilleometer, an obsolete thyroid test. All of the testing and physical examination of Echezabal revealed no thyroid or metabolic abnormalities. Like Hancock after her, Echezabal was given diet literature, including a booklet called "Lo-Carbo Diet," and was advised to avoid starches, sugar, and alcoholic beverages. Respondent also discussed Echezabal's diet and eating habits. Echezabal returned to Respondent's office on December 3, 1971, January 12, 1972 and April 7, 1972. As was his practice on follow-up visits, Warhola had his office staff weigh Echezabal and take her blood pressure. Although no additional electrocardiogram was performed, Warhola did not take Echezabal's pulse rate or listen to her heart sounds. In fact, he did no further physical examination of Echezabal at all. He just discussed diet and whether Echezabal was following her diet. After a hiatus of two years, Echezabal went back to Respondent on or about August 20, 1973. In accordance with his practice, Warhola treated Echezabal as he would a new patient since she had not been to his office for over a year. Warhola had Echezabal update her patient history in the same manner in which he did her original patient history. His physical examination and testing also was the same as on the initial visit in 1971. Once again, the examination and testing revealed no thyroid or metabolic abnormalities. Warhola also discussed with the patient her diet and eating habits. Echezabal returned to Respondent's office on November 16, 1973. On this follow-up visit, Warhola had his office staff take Echezabal's blood pressure and weigh her. Otherwise, Warhola did not physically examine Echezabal. Her pulse rate was not taken, there was no additional electrocardiogram, and Respondent did not listen to her heart. Warhola did, however, again discuss Echezabal's diet and eating habits. It is clear from Echezabal's testimony that Respondent's treatment of her before May, 1979, included the use of medications. Echezabal did not ask, and was never advised either verbally or by labeling, of the names of the drugs which were dispensed to her by Respondent. As with all his patients, Respondent documented the drugs dispensed to Echezabal by utilizing medication codes instead of the common name for the drugs. The medication codes were then recorded in the patient charts. Because the medication codes have changed over the years, the identities of the drugs dispensed to Echezabal before May, 1979, are unknown. Echezabal did not return to Respondent's office again until May 29, 1979. Because it had been about 5 1/2 years since Echezabal's last visit, Respondent treated her as a new patient, requiring the same updates to her patient history and having the same examinations and tests performed, including an electrocardiogram. Testing indicated that Echezabal was marginally anemic, and Respondent prescribed and dispensed iron tablets only and told her to return for a follow-up visit. Otherwise, the examination and testing revealed no abnormalities. Echezabal returned for a follow-up visit on June 11, 1979. On that date, Warhola had his office staff take Echezabal's blood pressure and weigh her. Additionally, office staff obtained a hemoglobin and hematocrit count on Echezabal and drew blood for analysis at an outside laboratory. Warhola did not take Echezabal's pulse rate or do another electrocardiogram or listen to her heart sounds. Warhola did no other physical examination of Respondent on June 11, 1979, but only discussed diet and eating habits. On or about June 11, 1979, Respondent dispensed to Echezabal 28 ferrous sulfate 5 gr. tablets, 28 Thyroid 2 gr. tablets, 112 phendimetrazine 35 mg. tablets, 28 Benadryl 50 mg. tablets, and 28 multi vitamin/mineral tablets, with instructions to begin taking the pills on the next day. When Respondent dispensed the above-mentioned drugs on June 11, 1979, Respondent did not have the results of tests which were to be performed by an outside laboratory on blood drawn by office staff. (Respondent had ordered a SMA 15 profile, which includes testing for glucose levels, and a thyroid study done on the blood specimen.) However, Respondent would have contacted patient Echezabal when the results came back the next day if he thought the results contra-indicated any of the medications. On or about June 12, 1979, Respondent received the results of a thyroid study and SMA 15 profile at Patterson Coleman Laboratories. The tests revealed no metabolic abnormalities. The test did reveal a slight abnormality in the T3 value, which was "34". The T3 value measures thyroid uptake and was only marginally below normal limits. In determining whether there is abnormal thyroid function, the "T3" value is only one factor to be considered. In view of the fact that the two other pertinent values, the thyroxine, or T4 value, and the "FTI" value were within normal limits, Echezabal could not properly have been diagnosed as suffering from abnormal thyroid function. Furthermore, it would be inappropriate to prescribe thyroid medication, given the results of the thyroid study done in June 1979. Respondent's records for Echezabal do not document any history of an abnormal thyroid function or any history involving thyroid medications taken by Echezabal prior to 1971. Despite the fact that patient Echezabal revealed no conclusive evidence of an abnormal thyroid function, Respondent failed to discontinue the thyroid medication which he ordered for Echezabal on June 11, 1979. On or about August 2, 1983, Echezabal returned to Respondent's office and was, again, treated like a new patient. Accordingly, Echezabal was asked to update her patient history. Additionally, office staff took Echezabal's blood pressure and pulse, and weighed Echezabal. This was the first occasion on which Echezabal's pulse rate was taken. On August 2, 1983, office staff obtained a hemoglobin and hematocrit count, performed a urinalysis and performed an electrocardiogram on Echezabal. Additionally, office staff drew blood for analysis by an outside laboratory. Finally, Warhola again discussed diet and eating habits with Echezabal. On or about August 2, 1983, Respondent dispensed or caused office staff to dispense to Hope Echezabal Cytomel 50 mg. (which is a thyroid medication similar to Thyroid and Levo Thyroid discussed above), phendimetrazine 35 mg., ferrous sulfate 5 gr. (iron), and Benadryl 50 mg., an antihistamine. Again, Respondent dispensed these medications without waiting for the results of SMA 26 profile which was to be performed on the blood specimen drawn by office staff at outside laboratories. On or about August 3, 1983, Respondent received the results of the SMA 26 which was performed at Central Medical Laboratory, Inc., which included an analysis of thyroid function. The tests revealed completely normal thyroid function. Despite evidence of normal thyroid function, Respondent failed to discontinue the Cytomel 50 mg. which he had prescribed for Echezabal. On or about September 8, 1983, Echezabal returned to Respondent's office. On that date, office staff took Echezabal's blood pressure and pulse. Additionally, office staff weighed Echezabal. Finally, as was his practice, Respondent spoke to Echezabal about her diet and eating habits. Respondent failed to conduct any kind of examination of Echezabal on September 8, 1983. Nor did Warhola do another electrocardiogram. On or about September 8, 1983, Respondent caused office staff to dispense 28 Cytomel 50 mg. tablets, 112 phendimetrazine 35 mg. tablets, 28 Benadryl 50 mg. tablets and 28 multi vitamin/mineral tablets to patient Echezabal. At the time Respondent caused these medications to be dispensed, his records reflected normal thyroid function in Echezabal. On or about April 21, 1984, Echezabal again came to Respondent's office for weight control purposes. On that date, office staff obtained an update in patient history, and obtained the patient's blood pressure, pulse, and weight. Also on that date, office staff obtained hematocrit and hemoglobin levels for the patient, a two hour post prandial blood sugar, and a urinalysis. Echezabal's blood pressure was 130/90 on April 21, 1984. Respondent spoke with Echezabal about her diet and eating habits. Respondent did not examine patient Echezabal at all on April 21, 1984. Nor did Warhola do another electrocardiogram. On or about April 21, 1984, Respondent caused office staff to dispense 28 Hydroreserpine .25 mg. tablets, 28 Levo Thyroid .1 mg. tablets, 56 phentermine 30 mg. tablets, 28 Benadryl 50 mg. tablets, and 28 multi vitamin/mineral tablets to Echezabal with instructions to start taking the pills the next day. At the time Respondent dispensed the above-mentioned drugs, his own records for patient Echezabal revealed normal thyroid function. Hydroreserpine is the brand name for a compound containing a diuretic and reserpine (which has previously been described above). Hydroreserpine is typically given as an anit-hypertensive agent. On or about April 22, 1984, Echezabal began to take the medications dispensed by Respondent on April 21, 1984, in the manner directed by Respondent. Accordingly, Echezabal would have taken 4 tablets by noon on that date. Echezabal should have taken by 10:00 a.m., on April 22, 1984, a green Hydroreserpine .25 mg. tablet (probably before breakfast), a yellow phentermine 30 mg. tablet (probably before breakfast), a yellow Levo Thyroid .1 mg. tablet (probably at 10:00 a.m.) and a white phentermine 30 mg. tablet (at 10:00 am.). After taking her 10:00 a.m. medication, Echezabal experienced a reaction to the medication. Specifically, Echezabal vomited and was hyperventilating. Echezabal rested for a period of time and was later transported to University Community Hospital in Tampa, Florida, by ambulance, where she was treated for a drug overdose. At no time during his treatment of patient Echezabal did Echezabal ask, or did Respondent advise Echezabal of, the names of the drugs which were dispensed by his office staff to Echezabal. Furthermore, the labeling for the substances dispensed to Echezabal did not contain the name of the medications dispensed. When Echezabal arrived at University Community Hospital, neither Echezabal nor her husband, Henry, who drove her to the hospital, knew what drugs Mrs. Echezabal had taken on the morning of April 22, 1984. At the time of admission at University Community Hospital, blood and urine specimens were taken from Echezabal for analysis. A comprehensive drug profile showed no alcohol. A second test performed on gastric blood serum revealed ethanol in the blood serum in the amount of 0.016 GM percent. The amount would be relatively negligible. Respondent inappropriately dispensed medications to patient Echezabal in that: Thyroid medications were prescribed although Echezabal's thyroid was normal; Sympathomimetic amine was prescribed to be taken in combination with thyroid medication; Phentermine was prescribed on April 21, 1984, in excess of maximum dosages; and Respondent made no effort to treat Echezabal without drugs as a first line of treatment (especially when she lost a pound between May 28 and June 11, 1979, without any medication prescription.) Respondent failed to practice osteopathic medicine with acceptable levels of care, skill and treatment for the reasons listed in paragraph 55, above, and because Respondent did not examine or palpate Echezabal's neck for thyroid abnormalities on any visit, neither did an electrocardiogram nor listened to her heart sounds on follow-up visits or on April 21, 1984, and did not take her pulse on some visits. In addition to the matters set out in paragraphs 55 and 56, above, Respondent's records for patient Echezabal were not adequate to justify Respondent's treatment in that: The records do not detail weight control programs the patient had tried, diet medications taken or recent history of weight loss or gain and diet; The records do not justify starting Echezabal at relatively high dosages of phendimetrazine on June 11, 1979 and August 2, 1983; The records do not justify the Benadryl prescriptions; and; The records do not state whether the patient was on a diet or explain why she lost a pound between May 28 and June 11, 1979, without any medication prescription. PATIENT BETH HELLE Between on or about November 8, 1971, and on or about May 4, 1984, Respondent intermittently treated Beth Helle for weight control. On Helle's first visit, Warhola required a patient history which was adequate except it but did not detail the length of time the patient had experienced a weight problem, what diet medications she had taken, what kind of weight loss program she had been involved in or a history of the recent weight loss or gain and diet. It indicated a normal menstrual history. Warhola also performed an inadequate physical examination only in that Warhola did not take Helle's pulse or examine or palpate her neck for thyroid abnormality. He did not listen to her heart sounds, but he took Helle's cardiogram. Warhola also discussed diet with Helle. He told her what foods she could eat and gave her a book dealing with carbohydrate counts in different foods designed to assist the patient in limiting carbohydrate intake. The examination and testing of Helle on November 8, 1971, which included testing with an achilleometer, did not reveal any abnormal thyroid or metabolic function. Helle's patient history revealed hypertension in 1970, but that condition probably related to a pregnancy and miscarriage at that time. On or about November 8, 1971, Respondent caused office staff to dispense medications to Helle. Helle never asked, and Respondent never told Helle, what the medication were. The labels on medication dispensed to Helle (like Echezabal) did not contain the common name of the drug dispensed. In Respondent's records, the medication names are indicated in a code, which has since changed. The names of the medications dispensed by Respondent to Helle before 1984 are unknown. On or about May 12, 1975, Helle returned to Respondent's office for treatment. Since 3 1/2 years had passed, Helle was treated as a new patient. Helle's patient history was updated in the same manner as the original patient history. Again Warhola inadequately examined Helle only in that Helle's pulse rate was not taken, and Respondent did not examine and palpate Helle's neck. Warhola did not listen to her heart sounds, but he did perform an electrocardiogram of Helle among the tests he performed. Again, the examination and tests, which included testing with an achilleometer, revealed no abnormal thyroid or metabolic function. In addition to the examination and testing on May 12, 1975, Warhola again discussed diet with Helle. He had his office staff dispense medications to Helle. Helle did not ask, and Respondent did not verbally advise Helle of, the names of the drugs dispensed. Again, the labels were in code, and identities of the drugs are not now known. On or about June 16, 1975, Helle returned to Respondent's office. On this follow-up visit, Warhola had his office staff take and record Helle's blood pressure and weight. Her pulse was not taken, and no electrocardiogram was made. Warhola did not physically examine Helle and specifically did not listen to her heart sounds or examine or palpate her neck. Warhola again discussed eating habits and diet with Helle and had his office staff dispense medications. Again, Helle did not ask, and was not told, what the medications were, and the medication labeling did not reflect the drug name. The code on the label has been changed, and the identities of the drugs are not now known. Helle returned for another follow-up visit on October 30, 1975. Again, Warhola had his office staff take and record Helle's blood pressure and weight. Her pulse rate was not taken, and no electrocardiogram was made. Warhola did no physical examination and specifically did not listen to Helle's heart sounds or examine or palpate her neck. Respondent again discussed diet and eating habits with Helle. Helle did not return to Warhola's office for treatment until May 4, 1984. Since eight and 1/2 years had elapsed since her last visit, Helle was treated as a new patient the same type of update of her patient history was taken. Warhola also had his office staff take and record Helle's blood pressure, pulse and weight. Blood specimens for analysis at an outside laboratory also were drawn. Warhola did not listen to Helle's heart sounds but did make and review an electrocardiogram. He did not examine or palpate her neck. Finally, Respondent talked with Helle about her diet and eating habits, specifically advising her to avoid fatty foods. On or about May 4, 1984, Respondent caused office staff to dispense 28 trichloromethiazide 4-mg. tablets, 28 Levo Thyroid .1 mg. tablets, 112 phendimetrazine 35 mg. tablets, 112 phentermine 8 mg. tablets, 28 branfiber tablets, and 28 Benadryl 50 mg. tablets. Respondent dispensed these medications without waiting for the analysis by the outside laboratory of blood drawn from Helle on that date. Trichloromethiazide is an oral diuretic and anti- hypertensive agent. On or about May 5, 1984, Respondent received the results of a SMA 26 profile run on the blood specimen obtained from Helle on May 4, 1984. The laboratory results revealed normal thyroid function, normal glucose levels and normal metabolic function. On or about May 8, 1984, Respondent received the results of a TSH profile run on May 4, 1984. The test again revealed normal thyroid function. Respondent's records for patient Helle do not reveal any documentation of a history of abnormal thyroid function even though Helle testified at the formal hearing that she had experienced abnormal thyroid function previously. Proper documentation would include a description of the abnormality (hypothyroidism or hyperthyroidism); a statement as to how long the condition existed; and a description of how the condition was treated. This last factor would be most significant in this case because Respondent dispensed Levo Thyroid although Helle testified that she had previous reactions to another thyroid medication (Cytomel). Respondent's records contain no documentation of any abnormal thyroid function during Respondent's treatment of the patient. None of the medications dispensed by Respondent's office staff on May 4, 1984, were labeled in a manner which would identify the common name of the drug. Respondent inappropriately and excessively prescribed phentermine, phendimetrazine and Levo Thyroid to patient Helle, in that: The phentermine and phendimetrazine were prescribed and dispensed in excessive dosages; The phentermine and phendimetrazine were prescribed and dispensed on May 4, 1984, in combination (and in excessive dosages); Thyroid medication was prescribed on May 4, 1984, although Helle's thyroid was normal, according to information known to Warhola at that time; Thyroid medication was prescribed to be taken in combination with phentermine and phendime- trazine; and Respondent made no effort to treat Helle without drugs as a first line of treatment. Respondent failed to practice osteopathic medicine with acceptable levels of care, skill and treatment for the reasons listed in paragraph 72, above, and because Respondent did not examine or palpate Helle's neck for thyroid abnormalities on any visit, neither did an electrocardiogram nor listened to her heart sounds on two follow-up visits, and did not take her pulse on the first four of her five visits. In addition to the matters set out in paragraphs 72 and 73, above, Respondent's records for patient Helle were not adequate to justify Respondent's treatment in that: The records do not detail weight control programs the patient had tried, diet medications taken or recent history of weight gain or loss and diet; The records do not justify starting Helle at high dosages of phentimetrazine (much less in combination with the other drugs) on May 4, 1984; The records do not justify the Benadryl prescription; and the records do not detail what "swelling always" and "some fluid retention" notations mean, including the part of the body affected, the results of examination and Respondent's diagnosis.
Recommendation Based on the foregoing Findings Of Fact and Conclusions Of Law, it is recommended that the Board of Osteopathic Medical Examiners enter a final order holding Respondent, Michael J. Warhola, D.O., guilty of violating Sections 459.015(n),(q) and (t), Florida Statutes (1985), and suspending his license to practice osteopathic medicine for six months. RECOMMENDED this 4th day of March, 1987 in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of March, 1987.
Findings Of Fact At all times material hereto, Respondent has been a medical doctor having been issued license number 0029773 by the State of Florida. At all times material hereto, Respondent was an employee of the Atlantic Stress and Obesity Clinic, Inc., located in North Miami Beach, Florida. While employed there, Respondent treated Daniel Wolfenstein, Cindy Vegazo, Neal Schoenberg, James F. McDonald, Scott Brown and Virginia Hagerty at the Clinic. On or about October 9, 1981, Respondent prescribed 45 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Daniel Wolfenstein. Respondent did not prescribe the above-described controlled substance to Daniel Wolfenstein for a medically justifiable purpose. That prescription was inappropriate and in an excessive or inappropriate quantity. Between the dates of approximately March 10, 1981, and February 8, 1982, Respondent prescribed 405 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Cindy Vegazo. Respondent did not prescribe the above-described controlled substance to Cindy Vegazo for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. Between the dates of approximately October 9, 1981, and January 5, 1952, Respondent prescribed 90 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for Neal Schoenberg. Respondent did not prescribe the above-described controlled substance to Neal Schoenberg for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. Between the dates of approximately September 9, 1981, and January 22, 1952, Respondent prescribed 225 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for James F. McDonald. Respondent did not prescribe the above-described controlled substance to James F. McDonald for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. On or about October 13, 1981, Respondent prescribed 45 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for Scott Brown. Respondent did not prescribe the above-described controlled substance to Scott Brown for a medically justifiable purpose. Said prescription was inappropriate and in excessive or inappropriate quantity. Between the dates of approximately August 4, 1981, and December 29, 1981, Respondent prescribed 135 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Virginia Hagerty. Respondent did not prescribe the above-described controlled substance to Virginia Hagerty for a medically justifiable purpose. Said prescriptions were inappropriate and in excessive or inappropriate quantities. The medical records of each of the above-listed patients indicate that each patient was given a prescription for 45 methaqualone tablets each time that patient came to the Atlantic Stress and Obesity Clinic to see Respondent. All patients indicated on the form checklist given to them at the Clinic that they were seeking medical aid because they were depressed, tense, unable to sleep, and/or without ambition. The progress notes for each patient are identical to the notes from prior visits, all progress notes appear in two different handwritings, and all patients are diagnosed as suffering from anxiety and insomnia, thereby requiring 45 more methaqualone tablets. There appears no variation in dosage or in diagnosis. Methaqualone is a depressant, and, therefore, prescribing methaqualone to depressed patients is contraindicted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent guilty of Counts I through XIX of the Administrative Complaint and permanently revoking Respondent's license to practice medicine in the State of Florida. DONE and RECOMMENDED this 27th day of July, 1983, in Tallahassee, Leon County, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of July, 1983. COPIES FURNISHED: Charlie L. Adams, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Adolfo Z. Aguila, Esquire Midway Professional Building 55 Grand Canal Drive, Suite 404 Miami, Florida 33144 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy J. Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issues in this case are whether Respondent committed the allegations contained in the Amended Administrative Complaint, and if so, the penalty that should be imposed.
Findings Of Fact The Parties Petitioner Department of Health has regulatory jurisdiction over licensed physicians such as Respondent. In particular, Petitioner is authorized to file and prosecute an administrative complaint, as it has done in this instance, when a panel of the Board of Medicine has found probable cause exists to suspect that the physician has committed one or more disciplinable offenses. At all times relevant to this proceeding, Respondent was a physician licensed in the State of Florida, having been issued license number ME 36889, and his medical office was located at 7200 West Commercial Boulevard, Suite 210, Fort Lauderdale, Florida. As mentioned previously, Petitioner alleges in this cause that Respondent's treatment of patient L.V. fell below the minimum standard of care in that: thyroid medication was prescribed in the absence of medical necessity; or, even assuming that some amount of thyroid medication was indicated, L.V. was prescribed excessive doses of the drug. To facilitate the reader's understanding of these issues, the factual recitation will be preceded by a brief description of the thyroid gland and anterior pituitary, as well as the hormones secreted by these glands. Relevant Glands and Hormones The thyroid gland (or simply, "the thyroid") is one of the human body's primary endocrine glands. The thyroid secretes several thyroid hormones——Triiodothyronine ("T3"), the active form of thyroid hormone; and Thyroxine ("T4"), which is inactive——that control and regulate the body's metabolism, development, growth, and temperature. The production of T3 and T4 is regulated by thyroid- stimulating hormone ("TSH"), which is produced by the anterior pituitary gland. Generally speaking, when thyroid hormone levels are low, the production of TSH increases; conversely, TSH production decreases when thyroid hormones concentrations are high. Accordingly, a high TSH level is suggestive of an underactive thyroid or hypothyroidism, while a depressed level of TSH indicates an overactive thyroid or hyperthyroidism. Treatment of L.V. On October 7, 2008, patient L.V., a 57-year-old female, presented to Respondent's medical office to address, in the patient's words, "hormonal problems." As it was her first visit to Respondent's office, L.V. was asked to complete a new patient intake form that solicited, among other information, her current symptoms and previous medical conditions. In the form, L.V. disclosed a variety of complaints: dizziness, fatigue, insomnia, forgetfulness, a rapid heartbeat,2/ and post-menopausal symptoms. After completing the paperwork referenced above, L.V. was seen by Shirley Jimenez, Respondent's physician assistant, who conducted a physical examination3/ and gathered a complete history. During her visit with Ms. Jimenez, L.V. revealed, as an additional complaint, that she occasionally experienced intolerance to cold. At the conclusion of the October 7, 2008, appointment, Ms. Jimenez recommended, with Respondent's approval, that blood work be conducted——to determine, among other things, the levels of T3, T4, and TSH——and that L.V. return for a follow-up appointment in several weeks. On or about October 21, 2008, the results of L.V.'s blood work were forwarded to Respondent for his review. With respect to L.V.'s levels of T3, T4, and TSH, the laboratory report indicated the following values and reference ranges (i.e., the levels deemed "normal" by the laboratory): Hormone Result Reference Ranges T3, Free: 264 pg/dL 230-420 pg/dL T4, Free: 1.1 ng/dL 0.8-1.8 ng/dL TSH: 2.94 mIU/L 0.40-4.50 mIU/L L.V.'s next office appointment was on October 23, 2008, during which she met Respondent for the first time. On that date, Respondent determined, based upon a review of L.V.'s complaints and symptoms (fatigue, dizziness, cold intolerance, forgetfulness, and low basal body temperature) and an examination of the laboratory results——as enumerated above, a T3 level at the low end of the reference range and a TSH value greater than 2.50 mIU/L, considered by Respondent to be high in light of L.V.'s symptoms——that the patient suffered from thyroid dysfunction. Notably, and contrary to Petitioner's allegations, Respondent did not diagnose L.V. with hypothyroidism.4/ Believing that L.V.'s symptoms could be alleviated by increasing her T3 level into the upper half of the typical range (i.e., 350 pg/dL), Respondent prescribed a low dosage of desiccated thyroid——a medication prepared from pig thyroids, which contains both T3 and T4——in the amount of .25 grain, which L.V. was instructed to take twice daily.5/ By all accounts, L.V. began taking the desiccated thyroid medication on or about October 23, 2008, and continued to do so until April 19, 2009. L.V. appeared for her third appointment on November 12, 2008, during which the patient made no indication of adverse side effects from the desiccated thyroid. At the conclusion of the office visit, Respondent refilled L.V.'s prescription at the same dosage. One month later, on December 12, 2008, a second blood sample was collected from L.V. The results, which were reported to Respondent on December 22, 2008,6/ indicated little to no change in L.V.'s levels of T3, T4, and TSH: Hormone Result Reference Ranges T3, Free: 255 pg/dL 230-420 pg/dL T4, Free: 1.0 ng/dL 0.8-1.8 ng/dL TSH: 3.00 mIU/L 0.40-4.50 mIU/L During her next office appointment, which occurred on December 29, 2008, L.V. once again reported no adverse side effects from the medication. L.V. did, however, state that she continued to suffer from vertigo, fatigue, and forgetfulness. In light of these persistent symptoms, as well as the laboratory results that revealed no meaningful change in the levels of T3, T4, and TSH (indeed, the T3 value had decreased slightly), Respondent increased the dosage of desiccated thyroid to .5 grain twice daily. L.V. appeared for her fifth office visit on January 13, 2009, at which time she reported, once again, that she continued to experience vertigo and fatigue. Respondent concluded, reasonably, that L.V. should be continued on desiccated thyroid at the current dosage due to the relatively short amount of time that had elapsed (15 days) since the medication's increase to .5 grain twice daily; in other words, Respondent believed that the additional time was needed for the higher dosage to produce results. On February 10, 2009, L.V. provided a third blood sample, the results of which were reported to Respondent 14 days later. In contrast to the previous sample, which demonstrated little or no change in L.V.'s hormone levels, the February 10 laboratory report showed that the medication was beginning to achieve the desired effect——i.e., increases in the T3 and T4 hormones, as well as a corresponding decrease in TSH: Hormone Result Previous Result Reference Ranges T3, Free: 293 pg/dL 255 pg/dL 230-420 pg/dL T4, Free: 1.1 ng/dL 1.0 ng/dL 0.8-1.8 ng/dL TSH: 1.78 mIU/L 3.00 mIU/L 0.40-4.50 mIU/L L.V.'s final office appointment, at least as an active patient of Respondent's, was on February 24, 2009. During the visit, L.V. reported some improvement with her vertigo and fatigue, and, as was the case during each of the prior appointments, L.V. neither disclosed, nor did Respondent or his staff detect, any adverse side effects from the thyroid medication. In light of L.V.'s continued symptoms; her T3 level, which was still significantly below Respondent's target of 350 pg/dL; and demonstrated ability to tolerate the medication, Respondent determined that an increase of the desiccated thyroid to .5 grain three times daily would prove helpful. L.V.'s Hospitalization Nearly two months later, on April 19, 2009, L.V. presented to the emergency room at Coral Springs Medical Center ("Coral Springs") and reported that she was experiencing "chest pains"; she also informed the medical staff that she had been suffering, for approximately three weeks, from persistent diarrhea——a condition that L.V. had experienced on multiple occasions over the years, long before she began taking the desiccated thyroid medication prescribed by Respondent. Based upon the nature of the complaints, L.V. was promptly admitted to the hospital for evaluation and treatment. L.V. remained hospitalized at Coral Springs for the next several days, during which time no evidence of a cardiac event was discovered. Indeed, the treating cardiologist summed up L.V.'s symptoms as follows: "Non-cardiac chest pain. The less said about this the better. No further investigation needed." With respect to L.V.'s diarrhea, the treating endocrinologist, Dr. Vanessa Rodriguez, attributed the symptom to iatrogenic hyperthyroidism (i.e., physician-induced overactive thyroid). Dr. Rodriguez reached this conclusion based upon L.V.'s low TSH level (.02 and .03 mIU/L on April 19 and 21, respectively), notwithstanding L.V.'s normal thyroid values7/ and the absence of symptoms frequently associated with hyperthyroidism, such as rapid heartbeat,8/ tremors, and hyperreflexia. Based upon her diagnosis——which, as discussed later in this Recommended Order, is rebutted by the credible testimony of Respondent's expert——Dr. Rodriguez instructed L.V. to discontinue the desiccated thyroid medication. Expert Testimony During the final hearing in this cause, Petitioner presented the testimony of Dr. Elton Shapiro, a board-certified endocrinologist, in support of its contention that Respondent's treatment of L.V. departed from the standard of care. During his direct examination, Dr. Shapiro opined, first, that Respondent violated the standard of care by initiating treatment with desiccated thyroid medication where the patient's TSH did not fall outside the testing laboratory's reference range. In Dr. Shapiro's view, once it is determined that a patient's TSH level is within the upper limit of the reference range established by the laboratory (typically 4.5 mIU/L),9/ it is improper for a physician to begin thyroid supplementation——irrespective of the patient's symptoms,10/ thyroid hormone levels (i.e., T3 and T4), or the proximity of the TSH value to the upper end of the range. Thus, per Dr. Shapiro's conception of the standard of care, a physician would commit misconduct by prescribing, ab initio, thyroid medication to a patient with a TSH of 4.4 mIU/L (a value barely within the upper limit), even if the levels of T3 and T4 are low and the patient exhibits symptoms consistent with thyroid dysfunction. Dr. Shapiro further opined that once thyroid medication is prescribed——which, per the witness, may only occur if the TSH is greater than 4.5 mIU/L——a physician should endeavor to decrease the patient's TSH to a range of .3-3.0 mIU/L, with an optimum level of 2.0 mIU/L. Thus, Dr. Shapiro accepts as "normal," for initial diagnostic purposes, a TSH level that does not exceed the upper reference range of 4.5 mIU/L; upon the initiation of therapy, however, a TSH level previously regarded during the diagnostic phase as acceptable (e.g., 4.0 mIU/L) is less than ideal and worthy of downward movement. In other words, what is considered "normal" or optimal depends, in Dr. Shapiro's view, on whether the patient has already been placed on thyroid medication or has yet to begin such therapy.11/ With respect to Respondent's treatment of L.V. during the period of November 2008 through February 2009 (i.e., after the patient began taking thyroid medication), Dr. Shapiro testified that Respondent deviated from the standard of care by: ordering a refill of the thyroid medication in November 2008; increasing the dosage of thyroid medication in December 2008; continuing L.V. on the medication in January 2009; and increasing the dosage a second time in February 2009. As the sole basis for his opinion that continued treatment was not warranted, Dr. Shapiro noted that L.V.'s TSH levels in December 2008 and February 2009 (3.00 mIU/L and 1.78 mIU/L, respectively) did not exceed the upper end of the laboratory reference range (4.5 mIU/L) and were therefore "normal." This testimony appears, however, to be inconsistent with the witness' own standard, as described in the previous paragraph of this Recommend Order: i.e., once thyroid supplementation has begun, the laboratory reference ranges are supplanted by a permissible range of .3-3.0 mIU/L and a target of 2.0 mIU/L.12/ Finally, Dr. Shapiro opined, based solely upon L.V.'s extremely low TSH levels upon her admission to the hospital, that Respondent's treatment resulted in the patient's development of iatrogenic hyperthyroidism. On cross-examination, Dr. Shapiro was asked, on a number of occasions, to enumerate the sources upon which he relied in his articulation of the standard of care. In response, Dr. Shapiro repeatedly testified that his opinions were derived from guidelines promulgated by the American College of Endocrinology ("ACE guidelines"),13/ which contemplate that thyroid supplementation is properly initiated only where a patient's TSH level is greater than the testing laboratory's reference range14/; once treatment is initiated, the guidelines call for a TSH range of .3-3.0 mIU/L and a target of 2.0 mIU/L.15/ Critically, however, Dr. Shapiro never testified that the ACE guidelines were intended by its drafters to establish a standard of care, nor, more importantly, did he testify that Florida physicians adhere to these guidelines with such uniformity that they mark the standard of a minimally competent practitioner. Instead, Dr. Shapiro's testimony simply reflects that he regards the ACE guidelines as absolute and binding, which, as discussed later in this Recommended Order, is insufficient to establish the standard of care by clear and convincing evidence. Even assuming that Dr. Shapiro' exclusive reliance on the ACE guidelines is a deficiency that can be brushed aside, the undersigned would nevertheless reject his opinions in favor of those articulated by Respondent's expert witness, Dr. Edwin Lee.16/ Dr. Lee, a board-certified endocrinologist, credibly opined, first, that Respondent's initiation of treatment was consistent with the standard of care in light of L.V.'s symptoms, initial TSH value (which exceeded 2.5 mIU/L), as well as L.V.'s level of T3, Free, which was measured at the low end of the reference range. (Dr. Lee explained that 95% of normal patients have a TSH level of 2.5 mIU/L or less, and that a value in excess of 2.5 mIU/L is an indication of mild underactive thyroid.) Further, Dr. Lee testified, again credibly, that Respondent's continued treatment of L.V. with increasing levels17/ of desiccated thyroid supplementation comported with the standard of care where the patient, who had demonstrated no adverse reactions to the medication, continued to present with symptoms and sub-optimal laboratory values (i.e., levels of T3 below an ideal range of 300-350 pg/dL, and TSH values outside a target range of .3-1.0 mIU/L). Finally, Dr. Lee credibly opined that that Respondent's treatment of L.V. with desiccated thyroid medication did not result in iatrogenic hyperthyroidism. In support of this opinion, Dr. Lee emphasized, among other factors, that L.V.'s T3 and T4 levels, as well as heart rate, were entirely normal upon the patient's admission to the hospital.18/ Dr. Lee further observed, correctly in the undersigned's view, that L.V.'s persistent diarrhea——a condition from which the patient had suffered on multiple occasions over the years, long before she began treatment with Respondent——was more likely caused by medications (Flagyl and Levaquin) prescribed by another physician.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Board of Medicine dismissing Counts I and II of the Amended Administrative Complaint. DONE AND ENTERED this 7th day of January, 2013, in Tallahassee, Leon County, Florida. S EDWARD T. BAUER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 7th day of January, 2013.
Findings Of Fact Surindar S. Bedi, Respondent, is licensed as a medical doctor by the Florida Board of Medical Examiners and was so licensed at all times here relevant. He is board certified in family practice and has offices in Zephyrhills and Elfers, Florida. The charges involving six of the complaining witnesses arose following either a local health fair or open house (when Respondent opened his new office) at which these witnesses had a free EKG strip taken. At the health fair Respondent had set up facilities to take strip EKG's of persons so desiring them at no cost. Those given the EKG filled out a release form on which they gave name, address, age, phone number, date of birth, weight, height, whether they had high blood pressure, heart condition, stroke or diabetes, and medications they were taking. They were told that they would be notified by phone if any abnormalities were disclosed in the EKG and by letter if the EKG was normal. John Morris was 74 years old when he and his wife visited the health fair at Gulf View Mall in Port Richey July 23, 1982. At that time Mrs. Morris thought the health fair was sponsored by the county medical association and suggested to John Morris that he take the EKG offered, which he did. In the release form the heart condition, stroke, and diabetes boxes were checked yes, and under medications were listed Pronestyl, Quinidex, Isordil, Digitalis, and Procane (Exhibit 7). In March, 1976, Morris had a massive heart attack, a stroke in 1977, and was in intensive care for 43 days in 1979 with another coronary accident. Prior to the hearing, Mr. Morris has had three cardiac arrests and three strokes or near-strokes. As a result Mrs. Morris had been exposed to cardiovascular illness for several years and, as an intelligent lady, has acquired considerable knowledge of the subject. Approximately one week after the strip EKG was taken at the mall, Mrs. Morris received a telephone call from a female referring to the EKG strip taken at the mall and telling Mrs. Morris that the EKG showed irregularities and that Mr. Morris should have a full EKG taken immediately. This call was received Friday afternoon around 3:00 p.m. Mrs. Morris offered to bring her husband down immediately for the EKG but was told it was not necessary because they closed at 4:00 p.m. An appointment was made for 11:15 a.m. Monday. Mrs. Morris proceeded to the Pasco County Medical Society office on Route 54 with her husband. Upon arrival she was told the county medical society had not participated in the health fair and it was a private clinic that had participated. Mrs. Morris then drove to Bedi Medical Complex on the same road as the Pasco County Medical Society office. Upon arrival she told her husband to stay in the car. She went inside and asked if John Morris had an appointment for 11:15. When told yes, Mrs. Morris demanded all medical records they had on her husband to take to his regular doctor. After a short consultation she was given Exhibit 7. When told that the EKG was irregular, Mrs. Morris was quite concerned. When told that the full EKG could wait until a later time, Mrs. Morris, who was well aware of the necessity of prompt medical attention when a heart starts acting up, was upset. When she learned the appointment had been made with a private clinic, she was resolute in her decision to take the records to the doctor who was familiar with John Morris' medical history and condition. Allen R. Smith, M.D., completed his residency in internal medicine and became board certified in 1978. He started treating John Morris as a patient in October, 1981. When Mrs. Morris brought her husband to Smith's office, after the strip EKG had been taken at the mall, on his next scheduled visit, September 12, 1982, she requested an EKG be taken and gave Dr. Smith the strip EKG she had obtained from Respondent's clinic. All strips taken by Respondent or his associates and presented at this hearing were of poor quality due to wandering base lines with artifacts all through the strips. Artifacts are interferences from the electrical circuit into which the EKG machine is plugged and anything else not related to the heart that causes the needle to move. Although Respondent and Dr. Costarella both testified that certain information other than heart rhythm can be obtained from a single lead (strip) EKG, all of the other medical witnesses concurred that the only reliable evidence obtainable from a strip EKG is heart rhythm. The normal EKG contains 12 leads which measure electrical activity at various parts of the heart so a picture of the entire heart is generated; while a rhythm strip shows activity at only one point on the heart. With respect to the rhythm strip taken on Morris, all witnesses who examined the EKG found it to be of poor quality. Even Dr. Costarella, who worked at the clinic with Respondent and initially read the strip and marked it slightly abnormal, testified the strip was closer to being one that should be repeated than to abnormal. Dr. Smith categorized this strip as "It simply isn't readable. It's a bad rhythm strip. It's just uninterpretable." (TR p.155) Helvi Grinko went to Respondent's open house in March, 1982, with her husband and was given a free strip EKG (Exhibit 4). Dr. Bedi placed the lead on Mrs. Grinko's chest and operated the machine. Upon completion of the strip he told Mrs. Grinko she had a short life expectancy. Grinko testified that Respondent taped the lead to her chest with a piece of adhesive tape. Respondent contends he placed the lead under Grinko's breast and had to lift up the breast to properly secure the lead. It is not credible that Mrs. Grinko would fail to remember such a procedure. This patient is very much overweight but has never experienced any heart problems. At the open house she had been shown around the medical center and given a brochure on Respondent's diet program. She also talked to Respondent's father, who was presented as living proof of the success of Respondent's dietary program, which he calls the Polarization Diet. Mrs. Grinko testified that she was so stunned when told she was going to die that she does not remember much that occurred subsequent thereto. Respondent denied telling Mrs. Grinko she was going to die. After Mrs. Grinko left Respondent's clinic, she was called twice by someone identifying herself as calling from Bedi's clinic and asking her to come so Bedi could help her. When Mrs. Grinko went North on vacation in May, she visited her former family doctor who did an EKG but prescribed no medication or any other treatment for her. Dr. Sandra Mann examined Helvi Grinko when the latter moved to the area in 1981 and wanted to establish a family doctor. Dr. Mann is an internist. The EKG taken on Mrs. Grinko in April, 1981, indicated diffuse STD changes, there were no direct cardiac symptoms but her history of hypertension and overweight indicated further studies were needed to rule out heart problems. These other studies did not reveal any heart problems. Because of the wandering base line on Exhibit 4, the strip EKG taken on Grinko at Respondent's clinic cannot establish any irregularity in Grinko's heart. Randall H. Sells, M.D., is board certified in family practice and Helvi Grinko has been a patient of his since January, 1983. When he first examined her and took a cardiogram, it was perfectly normal. This patient has high blood pressure, is overweight, and has arthritic problems. His examination, Exhibit 4 and Exhibit 30, the one lead rhythm strip taken by Respondent on Grinko, reveals no irregular beats and, in his opinion, no diagnosis of serious heart problems can be made from this strip. This conclusion is concurred in by Dr. Neufeld (Exhibit 20 p. 16) who found this strip EKG to be of technically poor quality and showing no abnormality of heart. On the other hand, Respondent found the poor T-waves and obesity of patient indicated she may be hypothyroid. He showed her some literature used in conjunction with his Polarization Diet program which indicated people should stop killing themselves with what they eat. Dr. Costarella read Exhibits 4 and 30 as very bad because of the absence of T-waves which indicate the heart does not rest between beats. He acknowledged on cross- examination that a poor connection of the single lead could cause loss of T- waves, and the strip EKG could not support a conclusion that the patient had a serious heart condition. Salvatore Guerrera is 61 years old and has had poor circulation for sometime before he retired and came to Florida in 1980. He attended the health fair in July, 1982, conducted by Respondent and had an EKG strip taken. A short time later Guerrera was called by Respondent's clinic regarding the EKG and was told the EKG showed abnormalities. Mrs. Guerrera made an appointment for him to go to the clinic. While there with Mrs. Guerrera he was shown the strip EKG by Respondent and told something was wrong with his heart. When Mrs. Guerrera asked how could he tell from such a small strip, Respondent took a full 12-lead EKG and again pronounced Guerrera's heart was not beating right and tried to interest the Guerreras in his Polarization Diet program. Mrs. Guerrera suffers from agoraphobia and she testified by deposition (Exhibit 12). Respondent pointed out how much she needed her husband to take her places she could not go alone and that she should take care of him because he was the only husband she had. Guerrera did not enroll in Respondent's nutrition program but went to see his regular doctor, Allen Smith, for a checkup. Dr. Smith had first seen Guerrera October 10, 1980, when he came as a new patient. Dr. Smith saw Guerrera in his office on September 3, 1982. Guerrera's medical records (Exhibit 8) show he told Dr. Smith that he had been told by Respondent that he had an abnormal EKG and would die if he did not get nutritional prescriptions. The EKG taken by Smith showed no abnormality. When Guerrera returned four days later complaining of chest pressure, Dr. Smith suspected a hiatal hernia and subsequent tests so found. No diagnostic irregularities in Guerrera's EKG had been found by Smith and no cardiac symptoms are indicated. Guerrera has a slow heart rate (sinus bradycardia) but from the EKG Smith could not conclude Guerrera has a heart problem. Dr. Smith then obtained Guerrera's medical records from Respondent (Exhibit 9). The EKG in these records showed sinus bradycardia, some coarse artifact irregularity of the base line, but no other abnormal conditions. With no specific complaint of discomfort from the patient which would require further investigation, the EKG and patient history will not support a diagnosis of heart disease. Phyllis Hagedorn is a 62-year-old retired school teacher who attended the health fair in July, 1982, with her husband and participated in the free EKG strip. Mrs. Hagedorn is overweight and has a tendency towards high blood pressure. For this she took a drug called Apresazide. A few weeks after the health fair Mrs. Hagedorn received a telephone call suggesting she come to Respondent's clinic for a free complete EKG. About one week later she received a second call advising that the EKG taken at the health fair showed a slight irregularity and she should come in for a full EKG. She made an appointment for early September, 1982, at which time she went to the clinic where a full EKG was taken. She was then invited into a classroom area where Respondent discussed problems he observed on the EKG and to hear about a program on nutrition. Respondent marked with a pen on Hagedorn's EGK showing problem areas and advised Mrs. Hagadorn that she had a 70 percent blockage but his nutritional and exercise program could correct her condition. The price of $160 was quoted for four sessions at weekly intervals where she would be shown how to prepare tasty meals without the harmful fats, oils, salts, etc. If her husband also attended the price for him would be less than $160. Mrs. Hagedorn then went to her family doctor, Randall B. Sells, who is board certified in family practice. Dr. Sells, at patient's request, took a 12- lead EKG and no evidence of heart disease was found. When Dr. Sells examined the strip EKG and the full EKG taken by Respondent, he found both of them inadequate for diagnostic purposes. The strip was inadequate for the same reasons given with respect to the other strip EKG's. The full EKG had a wandering base line which makes it almost impossible to tell about the elevation or depression of the ST segments (TR p.54) . From a purely technical standpoint this EKG was inadequate to diagnose heart irregularities or abnormalities of the patient. No ischemic changes are observable in the EKG and, absent physical complaints from the patient, no blockage of the blood vessels can be predicted, let alone a specific percentage. Mrs. Hagedorn was subsequently subjected to a stress test but the test was stopped before any results could be reached because of difficulty in walking on the treadmill. Dr. Neufeld reviewed Respondent's records of Mrs. Hagedorn and found the strip EKG to be poor with a wandering base line but showed normal rhythm. The full EKG taken also had a wandering base line and Neufeld could find thereon no evidence of heart disease. Neither of these EKG's were technically capable of being used to make a definitive diagnosis regarding heart disease of Phyllis Hagedorn. Accordingly, no diagnosis of vessel blockage of 50 to 70 percent could be made from those EKG's. Ellen Buonocore and Robert Neville attended the health fair in July, 1982, and participated in the free EKG strips. About a month later Ms. Buonocore received a call advising her that there was an irregularity in the EKG and she should come in for a full EKG. She was also told there was an irregularity in Neville's EKG and he, too, should come in. She made an appointment for both of them. After a full EKG was taken Respondent, with EKG in hand, pointed out to Buonocore various irregularities and suggested she have a full physical examination. Neville suggested they go to their regular doctor. Respondent offered them a full physical exam for $70 each. Since that was less than they expected to pay their regular doctor, they accepted. Neville went for his physical exam the day before Buonocore and came back with her for a stress test. Respondent had told Neville that he was receiving an inadequate supply of blood to his brain and recommended the stress test to determine the extent of blockage. Buonocore was also told she had an inadequate flow of blood to the brain and she wanted all the tests Neville had been given. No extra charge for the stress test was quoted to Buonocore but the evidence is in dispute whether or not Neville was told there was an extra charge for this. Both commenced the stress test but Buonocore did not complete the test because the room was not air conditioned and it got too hot. When both complained of the bills exceeding the $70 quoted, the amount Neville had paid over $70 was refunded and Buonocore was charged only $70. Buonocore testified that during her eye examination Respondent called the nurse over to show what Buonocore understood to be a cataract in her eye. She also testified that he conducted the examination with a pen light. Respondent testified he used an ophthalmoscope, called the nurse over to show her an arcus senilis which some people thought was a cataract. Nothing was said to Buonocore regarding her having a cataract and no such indication was entered in the physical exam; accordingly, Respondent's version of the cataract incident is found to be correct. The EKG's taken by Respondent and subsequent EKG's taken by others reveal that Buonocore has earlier had a mild infarction of which she was unaware at the time it occurred and there has been no significant change since that time; and that Neville has a right bundle branch block which causes deep Q-waves in one lead which are not present in others, and therefore that Q-wave cannot be interpreted as lack of blood supply or evidence of ischemia. This diagnosis was concurred in by Dr. Neufeld, who opined that a diagnosis of heart disease could not be made from the EKG 's and physical examination taken by Respondent on Buonocore and Neville. Mary Mundy, a 57-year-old housewife, had been a patient of Respondent for treatment of back injury suffered in an automobile accident in 1980. On September 21, 1982, Mrs. Mundy went to her gynecologist, Dr. Madani, for a checkup and annual Pap smear. The Pap smear indicated the presence of squamous cell carcinoma. After discussing the problem with Mundy and her husband, Dr. Madani, on October 12, 1982, performed a fractional D and C and a cervical cone biopsy to check the tissue at the cervix. The tissue sample went to the lab and came back positive for cancer. Dr. Madani told Mrs. Mundy and her husband that she should have a hysterectomy to cure the cancer. She agreed and her operation was scheduled for about one month after the cone biopsy. Mrs. Mundy then called Respondent for an appointment to get a second Pap smear. When she arrived at his office and they were in consultation, she asked for a second Pap smear. Instead of examining her or performing the Pap test, Respondent talked to her about some of the programs he was running at the clinic and indicated to Mrs. Mundy that if she went on his diet and exercise programs she might not have to undergo the hysterectomy. He also discussed chelation therapy and Mrs. Mundy saw several people walking around the clinic carrying IV bottles taking chelation therapy. Although denied by Respondent, Mrs. Mundy was also told by Respondent that if it was his own mother he would not recommend a hysterectomy. Regardless of the words used, Respondent conveyed to Mrs. Mundy the concept that her cancer could be treated and cured by diet, exercise, chelation therapy, and/or laetrile. Respondent does not use laetrile in his practice and has never used laetrile so his purpose in mentioning that drug is not clear. After leaving Respondent's clinic, Mrs. Mundy realized that she had no choice but to have the hysterectomy and went to the hospital the next week as scheduled. Ernest Wiard is 69 years old and retired in 1970. In 1978 he had a blood clot and cardiac failure and has taken Coumadin since that time. When he moved to Florida in 1978, he was taking Aldomet, Apresoline, Lasix, Zyloprim, Colchicine, Digoxin, and Coumadin for his heart condition, gout, blood pressure, blood thinner, and excess fluids. He introduced himself at Bedi's clinic and was checked by Respondent's physician's assistant and got his prescriptions for these medications. Wiard first saw Bedi in October, 1980, for his three-month checkup. At that time he did not need any prescription refills. On January 15, 1981, Wiard went to the pharmacy to get his prescription for Coumadin refilled. The pharmacist noted the prescription was over a year old, could not be refilled, and that Wiard needed a new prescription. He told Wiard he would call Bedi's clinic and that Wiard could return later in the day for his medication. Later that afternoon Wiard returned to the pharmacy and was told the clinic had never called back. Wiard had been told by his previous doctor that he would always have to take Coumadin so he then went to the clinic and saw Respondent. Respondent took out Wiard's chart and told him that he wanted Wiard to come in the following day for a physical examination and that he wanted to put Wiard on his Polarization Diet and get him off of medication. Wiard told Respondent that he had been told he would be on Coumadin the rest of his life but no new prescription was forthcoming. The following day Wiard reported to the clinic and spent all day undergoing his physical examination and the following day, January 17, 1981, after signing a release, he was given a stress test. During the examination Wiard requested the prescription for Coumadin. Respondent had Wiard bring his wife in so he could talk to both of them about the Polarization Diet. While preparing Wiard for this diet, Respondent told him to stop all medication but Digoxin. Respondent explained to Wiard how Respondent's father had been on numerous drugs as a result of heart problems and how he had been able to stop taking medication, start feeling good again, and enjoying good health since he went on the Polarization Diet and the exercise program. On January 20, 1981, when Wiard went to Respondent for his three-month checkup his legs were beginning to cramp and hurt him. He told Respondent his legs were beginning to stiffen and burn and asked to be put back on his medication. Respondent diagnosed this problem as lack of potassium and drug withdrawal without examining Wiard's legs. Respondent gave Wiard a prescription for Slow K to increase his potassium level and Tranxene for nerves. Wiard took those drugs as prescribed until he entered the hospital. When Wiard went to Respondent on January 16, 1981, to get his prescriptions renewed, he had three Coumadin left. These ran out January 18,1981. After the January 20 visit Wiard's legs continued to hurt and cramp. On Friday evening, February 2, 1981 Wiard's legs were hurting badly and Mrs. Wiard called Respondent's home. Respondent was going to his office to tend to another patient and told Mrs. Wiard to bring her husband down. That night around 9:00 p.m. Mrs. Wiard, with the help of a neighbor, got Mr. Wiard in the car and into Respondent's office. Wiard told Respondent that his legs were burning and cramping and Respondent told him to do an exercise demonstrated by Respondent, go home, and take two aspirin. Wiard again asked Respondent to put him back on his old medication. Respondent asked Wiard to continue on his diet and exercise program for another week to give it a chance to work. Wiard testified that Respondent did not examine his legs. Respondent testified that he did examine Wiard's legs and found nothing wrong. No notes were made in Wiard's chart reporting the actions taken by Respondent on that evening. The following Monday afternoon around 3:00 p.m., on February 5, 1981, Mrs. Wiard got her husband in the car and drove him to Respondent's office. Upon arrival she went in to get a wheelchair because Wiard's legs were so bad he could not walk. Respondent saw her and went out to the car with her to see Wiard. When he saw Wiard, Bedi apparently realized he had a sick man on his hands and asked Wiard if he wanted to go to the hospital. Wiard was sitting in the front seat on the passenger's side of the car. Respondent testified he opened the car door and examined Wiard's legs and saw no mottling or discoloration and felt a good pulse. Wiard and Mrs. Wiard testified Respondent did not examine Wiard's legs. Respondent told Wiard to go home and take two Coumadin, to which Wiard replied that he had no Coumadin. The physical configuration of the front seat of a car with a door obviously hinged to the front is such that an examination of the legs of the passenger whose feet were on the floor of the car would be awkward, if not difficult. At this time Respondent contends he first became aware that Wiard was no longer taking Coumadin after he asked Mrs. Wiard what drugs her husband was taking and Coumadin was not included in her reply. He felt two might be needed to thin the blood that had received no Coumadin for some two weeks. No explanation was provided why more specific action was not taken by Respondent when Mrs. Wiard told him he had no Coumadin to take. Respondent's testimony that Wiard's legs appeared normal to sight and touch does not square with a report of the emergency room at Dade City Community Hospital where Wiard was taken around 9:00 p.m. on February 5, 1981. Upon his arrival there Wiard was examined and found to have arterial occlusion of both lower extremities, the legs were mottled and discolored with evidence of very poor circulation. Treatment was beyond the capabilities of Dade City Community Hospital and Wiard was transferred to Tampa General Hospital by ambulance that night. He arrived at Tampa General early on the morning of February 6, 1981. His examination there revealed a major decrease in the blood supply to Wiard's legs (Exhibit 15 p. 7) and an irregular heartbeat. Arteriograms were taken which suggested a embolic occlusion. Further procedures were carried out. Heparin was administered for anticoagulation. Clots were removed from both legs and Wiard was carefully monitored for circulation in the legs. Ultimately on February 10, 1981, Wiard's right leg was amputated three inches above the knee. Respondent's Director of Public Relations, Linda Sharp, started working for Respondent the Monday following the health fair conducted mid-July, 1980. She is the one who made the telephone calls to those who had strip EKG's taken. She has been trained by Respondent to conduct seminars for senior citizens to explain heart disease and how diet relates to the circulatory system. She has had no medical training other than that provided by Respondent. Dr. Costerella had reviewed more than half of the strip EKG's taken and of those he reviewed only 10 to 15 percent were readable. On those that were too bad to read he put "irregular," "slightly abnormal," or "repeat." All of those strip EKG's with irregular or abnormal on them resulted in a phone call from Ms. Sharp telling the patients that they had an irregular or abnormal EKG and they should come in for a free full EKG. Once the patients came to the office they were given the free EKG and then given some explanation of the EKG and a sales pitch on the diet and exercise program. Respondent has embarked on a program he refers to as preventive medicine. He was led to this program a few years ago in trying to take care of his father who suffered from cardiovascular problems. During this time Respondent became a disciple of Dr. Sodi Pollaris, who is described by Respondent as being one of the foremost cardiologists in the world and who practices in Mexico, and who treats cardiac patients by dietary means. This diet focuses on fruit and vegetables, no red meat, reduction in salt, no canned vegetables, etc. Respondent talked to Dr. Sodi's patients in Mexico and tried the diet and exercise program on his father. When his father got better after going on the program and giving up his medications, Respondent further developed the program and solicited patients to come in to learn about the Polarization Diet. In setting up the strip EKG's at the open house and health fair at the mall, Respondent used those EKG's to get new patients into his office. Although Respondent contends he is trying to help those cardiac patients to a better life, and, in fact, made no money whatsoever on several of the witnesses who testified in these proceedings, nevertheless he brought these people into his office by giving them inaccurate medical information and thereafter attempted to sell them on his program. Respondent's testimony that he can read changes in the electrocardiogram when the patient goes on the diet and can detect patients' cheating on the diet by use of an electrocardiogram differs from the testimony given by all other witnesses regarding the information obtainable from an electrocardiogram. Furthermore, his testimony that such information can be obtained from a strip EKG also conflicts with all other medical testimony presented. This misplaced confidence also appears in the use of stress tests by Respondent. All other medical witnesses who testified on the subject of stress tests did not deem it prudent for anyone other than a cardiologist to give a patient a stress test; and then, only if appropriate equipment was readily available with the necessary expertise of the physician to take care of the cardiac accident which can readily occur during a stress test. These witnesses included family practitioners, such as Respondent, and internists. The latter are generally better qualified to treat heart patients than are family practitioners, although the latter are qualified to treat routine heart conditions.
