The Issue The issues are whether Respondents committed the acts or omissions alleged in four administrative complaints, and, if so, what penalty should be imposed against Respondents' licenses.
Findings Of Fact Petitioner proved the grounds alleged in paragraphs 1 through 3 of each Amended Complaint and the grounds alleged in paragraphs 1 through 5 of each Administrative Complaint. Petitioner is the state agency responsible for regulating the practice of pharmacy in Florida pursuant to Section 20.43 and Chapters 456 and 465. Rx and Gordon are each licensed in Florida, respectively, as a community pharmacy and pharmacist pursuant to license numbers PH 17718 and PS 27618. Rx is a community pharmacy located at 5400 South University Drive, Suite 107, Davie, Florida 33328. Gordon is the pharmacy manager. Rx operates an Internet pharmacy. Rx fills prescriptions received over the Internet and dispenses the prescribed medications. A website company identified in the record as USAPrescriptions.com (USAP) obtains personal information from individuals responding to USAP advertisements on the Internet. USAP transmits the patient information to physicians who prescribe medication for the individuals and transmit the prescriptions and patient information to Rx by e-mail. Rx prints a written record of the electronically transmitted prescription, but the written record of the prescription is not the actual prescription. Rx then enters the patient information into its computer system; fills the prescription; labels the medication in accordance with the requirements of Section 893.04(1)(e); obtains a written confirmation of the prescription from the physician; and dispenses the medication to the patient by private courier. Petitioner conducted on-site inspections of Rx on April 6 and October 18, 2001. Petitioner proved the grounds alleged in paragraph 4(b) of the Amended Complaints. Many of the medications in evidence are controlled substances within the meaning of Section 893.03. None of the controlled substances are Schedule I or Schedule II drugs defined in Section 893.03(1) and (2). Most of the medications are Schedule III, IV, or V drugs defined in Section 893.03(3)-(5). The remaining medications are legend drugs that are not scheduled by statute. Most of the medications in evidence are controlled substances identified in the record as obesity drugs and marketed under the brand names Adipex, Bontril, Didrex, Ionamin, Meridia, Phentermine, and Tenuate. Other medications include Celebrex, Ultram, Valtrex, Viagra, Xenical, and Zyban. Petitioner failed to prove the allegation in subparagraph 4(a) of the Amended Complaints that Respondents filled prescriptions written by out-of-state physicians who prescribed medication based on Internet questionnaires. Rx and Gordon do not fill "written" prescriptions. Respondents fill electronic prescriptions that physicians transmit by e-mail. The electronic prescriptions are transmitted by "other means of communication" authorized in Section 893.02(20). Respondents reduce each electronic prescription to a written record referred to in Section 893.04(1)(a). The evidence is not clear and convincing that physicians prescribe based on Internet questionnaires. None of the prescribing physicians testified. The content of the Internet questionnaire is not established by clear and convincing evidence. The prescribing physicians provide Respondents with patient profiles that include medical information for each patient. Evidence that the patient profiles are an inadequate basis for the prescriptions is less than clear and convincing. Petitioner's experts relied on the adequacy of the patient profiles, in relevant part, to opine that Respondents failed to properly consult patient profiles before dispensing obesity drugs. Evidence that patient profiles were an adequate source of medical information to consult before dispensing drugs is inconsistent with allegations that the patient profiles received from the prescribing physicians were an inadequate basis for the prescription or that the Internet questionnaires did not include sufficient information. Inconsistent evidence and allegations are not clear and convincing. The allegation in paragraph 4(a) that an "out-of-state physician" transmitted the referenced prescription is not material to the statutory mandate for Respondents to determine the validity of the prescription. The statute requires a pharmacist to determine the validity of the prescription only when the prescribing physician is "licensed" in a state other than Florida. The physical location of the physician is immaterial. The trier of fact cannot infer that Petitioner intended to allege a material fact. The fact must be alleged in the plain language of the Amended Complaint. It may be reasonable for the fact-finder to infer that the physician is licensed in the state where he or she is located, but such an inference is less than clear and convincing. The ALJ has ruled that any ambiguity in the factual allegation must be construed in favor of the licensee because this is a license discipline proceeding. The evidence is less than clear and convincing that Gordon was present at Rx on April 6, 2001. The investigator's testimony that he interviewed Gordon on April 6, 2001, is not persuasive. That testimony conflicts with evidence that the investigator customarily documents interviews in his investigative report and did not document an interview with Gordon on April 6, 2001. Such inconsistent evidence is less than clear and convincing. Even if Gordon were found to be present during the inspection, the evidence does not show how long she was present or the nature and scope of her personal conduct concerning the alleged acts or omissions. The evidence is less than clear and convincing that the alleged acts or omissions were caused by misconduct on the part of Rx. The alleged acts or omissions are limited to April 6, 2001. Evidence relevant to the inspection conducted on April 6, 2001, consists primarily of the testimony of one inspector and two exhibits. The evidence is insufficient to show that unidentified employees of Rx engaged in the alleged acts or omissions in a persistent and practiced manner. The evidence is insufficient to support an inference that Rx is vicariously responsible for the alleged acts or omissions of its employees on April 6, 2001. Paragraph 4(c) in the Amended Complaints alleges that the prescriptions filled by Respondents were not valid because there was no patient-physician relationship upon which to base a treatment plan or "to justify prescribing medications." The evidence does not establish standards applicable to Respondents. The investigator's testimony makes clear that the alleged grounds are based on a rule promulgated by the Board of Medicine that is applicable only to physicians licensed in Florida. The ALJ has ruled in the Conclusions of Law that Petitioner has no jurisdiction to discipline Respondents for violating a rule applicable to physicians. No further findings are made concerning the grounds alleged in the Amended Complaints. Paragraph five in the Amended Complaints charges a violation based on facts alleged in the preceding four paragraphs of the complaint. The remaining references in the Recommended Order to a "paragraph" refer to paragraphs in the Administrative Complaints. Paragraph 5 alleges that the "inspection team observed" four technicians and one pharmacist dispensing medications on October 18, 2001, in violation of the maximum ratio of 3:1 prescribed in Section 465.014. The observations of the "inspection team" are a method of proof but, in this instance, include the fact sought to be proven. On October 18, 2001, Gordon was the only pharmacist on duty during the inspection. Four other employees were present at the time, but the evidence is less than clear and convincing that all four employees were technicians. Two members of Petitioner's inspection team found that Respondents maintained the correct ratio. One member is a licensed pharmacist. A third member found the ratio to be improper. Such inconsistent evidence is less than clear and convincing. As to paragraph 6, Petitioner proved that mislabeled drugs were present in the offices of Rx on October 18, 2001. The evidence is clear and convincing that a potentially dangerous pre-packaging procedure occurred on that day. The deficient procedure failed to properly label medications during the re-packaging process. The evidence of personal misconduct by Gordon on October 18, 2001, is less than clear and convincing. Although Gordon was present during the inspection, there is little detailed evidence of her personal conduct. The facts are similar for Rx. The evidence is less than clear and convincing that Rx directed its employees to commit the deficiencies or knew of the deficiencies. Uncontroverted admissions by Rx employees indicate they were instructed to use the deficient procedure to label vials. However, the evidence is insufficient to show that the instructions came personally from Gordon, the owners of Rx, or some other employee or manager. The evidence does not support an inference by the trier of fact that Rx or Gordon is vicariously responsible for the deficiencies. The evidence is insufficient to show that the labeling deficiencies on October 18, 2001, were persistent and practiced. The allegation is limited to a specific day, and the inspection team was not in the offices of Rx all day. The evidence established the standards required for Respondents to exercise due care. The medications were improperly labeled in vials loaded in bins prior to the time that an employee filled a specific prescription. The bins were labeled with the name of the medication and the number of pills. However, the vials did not contain a label stating the strength of the drug, dosage form, manufacturer's lot number or control number, and expiration date as required in Section 499.006(3) and Rule 64F-12.006(1). The standard of care is that the vials must be labeled with the requisite information before filling the vial rather than afterward. The potential for harm from mislabeled drugs is great. It is unsafe and dangerous to keep unlabeled prescription vials containing medications. However, the evidence is not clear and convincing that any actual harm occurred. No finding is made concerning the grounds alleged in paragraph 7. If the facts expressly alleged in paragraph seven were proven, those grounds would not prove any of the remaining charges. Paragraph 7 alleges virtually every fact related to the misuse of a Kirby-Lester machine except that Respondents actually misused the machine by not cleaning it after counting one type of medication and before counting a different type of medication. The allegation is that contamination can occur if the machine is not cleaned between medications. Paragraph 7 does not allege that any member of the inspection team observed Respondents using the machine to count different medications without cleaning the machine between medications. The trier of fact cannot draw an inference that facts not expressly stated were intended to be alleged. The allegation must appear in the plain language of the paragraph. Petitioner failed to prove the grounds alleged in paragraph 8. The evidence is less than clear and convincing that Respondents prepared, packaged, or held drugs under conditions that could contaminate the drugs with filth or render the drugs injurious to health. The evidence is less than clear and convincing that the drugs and drug packaging material referred to in the allegation were part of the dispensing process. The materials were being held for return to the manufacturer. Petitioner submitted no evidence showing that Respondents used the empty vials or vial tops to package medications or that Respondents actually dispensed pills that had been dropped on the floor. The evidence of Gordon's personal conduct concerning the alleged grounds is less than clear and convincing. The evidence does not show that the acts or omissions occurred in a persistent and practiced manner. The evidence is less than clear and convincing that Rx operated an unsanitary, unsafe, or unclean pharmacy or that Gordon managed such a pharmacy. It is reasonable for a busy pharmacy to accumulate debris and clutter on the floor in the course of a busy day. Routine clutter does not render a pharmacy unsafe, unclean, or unsanitary. Petitioner proved the allegation in paragraph 9 that unnamed employees at Rx received approximately 764 prescriptions on October 5, 2001, and that the prescriptions were not signed. Petitioner failed to prove that the prescriptions were written and required by law to be signed. The unsigned documents are not prescriptions within the meaning of Section 893.02(20). They are the written record of prescriptions that are transmitted electronically over the Internet. Paragraph 9 refers to Rule 64B8-9.012(4). That rule is promulgated by the Board of Medicine and applies to physicians. Respondents are not physicians. Petitioner proved part of the grounds alleged in Paragraph 10 but failed to prove a material ground. No finding is made regarding the remaining ground. Petitioner proved that Section 893.02(20) contains the provision quoted in paragraph 10. For reasons stated in paragraphs 9 through 11 of the Findings of Fact, evidence of the basis upon which the prescribing physicians ordered medications is less than clear and convincing. No finding is made concerning the allegation that "many of these . . . controlled substances . . . were prescribed. . . ." The prescribing physicians did not testify, and Respondents do not prescribe medications. Respondents fill prescriptions and dispense medications. No finding is made concerning paragraph 11. Paragraph 11 does not allege that Respondents committed any specific act or omission. Paragraph 11 recites Section 465.003(14). No finding is made concerning paragraphs 12 and 13. The grounds alleged in both paragraphs pertain to physicians rather than pharmacists. In relevant part, paragraph 14 alleges: Accordingly, Respondent is dispensing obesity medications prescribed without benefit of a valid patient/physician relationship in violation of Section 465.016(1)(i). . . For purposes of Section 465.016(1)(i) . . ., it shall be legally presumed that the . . . dispensing of . . . drugs in excessive or inappropriate quantities is not in . . . the course of the professional practice of pharmacy. Also, the practice constitutes violations of sections 894.04(1) and 893.02(20). . . for dispensing controlled substances outside the course of the professional practice of pharmacy by failing to determine whether the prescriptions were issued pursuant to a valid patient/physician relationship, and by failing to determine that the drugs so ordered are considered necessary for the continuation of treatment of a chronic or recurrent illness. (emphasis supplied) Paragraph 14 charges that Respondents violated the referenced statutes based on antecedent facts alleged in paragraphs 9 through 13 and incorporated by reference through terms such as "accordingly" and "the practice." Related counts in paragraphs 66-88 or 90 contain substantially similar charges based on facts alleged in paragraphs 1-65. The charges in paragraph 14 and related counts are read together to include relevant factual allegations in paragraphs 1-65. Section 893.02(20), in relevant part, requires a pharmacist to determine whether prescriptions from a physician licensed in a state other than Florida are issued pursuant to a valid patient-physician relationship, are authentic, and are necessary for the continuation of treatment of a chronic or recurrent illness (the validity test). The terms of the validity test are susceptible to different interpretations. The validity test could be construed to require a pharmacist to determine whether the physician considers the patient-physician relationship to be valid, the prescription authentic, and the drugs necessary. Alternatively, the validity test could require the pharmacist to substitute the pharmacist's judgment for that of the physician. The ALJ has determined that any ambiguity in the terms of the validity test must be construed in favor of Respondents and against the imposition of discipline. The ALJ has also determined that a requirement for a pharmacist to substitute her or his judgment to determine the medical necessity of medication may, in some cases, require the licensee to practice medicine. Respondents exercise reasonable care to ensure that the validity test has been satisfied, when applicable, by requiring the prescribing physician to sign a written verification of the prescriptions ordered by that physician. Respondents do not fill any prescription before Respondents receive a "site fill list" or "daily log" signed by the prescribing physician to verify the authenticity of the prescription, the validity of the patient-physician relationship, and the medical necessity of the medication. If pharmacists were required to substitute their judgment for that of prescribing physicians, the standards for exercising that judgment are less than clear and convincing. The requirement for a licensee to determine the validity of the patient-physician relationship applies only if the physician is licensed in a state other than Florida. Standards used to determine the validity of a patient-physician relationship vary from state to state. Clear and convincing evidence does not indicate whether a Florida pharmacist must apply Florida law to make the necessary determination or must apply the law of the state where the prescribing physician is licensed. Petitioner relies on an unwritten agency statement by the Board of Pharmacy to explicate the standards that pharmacists must use in determining the validity of a patient- physician relationship. The agency statement requires licensees to determine whether a prescribing physician, licensed in any state including Florida, has conducted an in-person examination of the patient prior to prescribing a medication. The agency statement holds that the absence of an in-person examination renders the prescription invalid. Findings pertaining to the agency statement are discussed further in the Conclusion of Law because continuity requires a simultaneous discussion of both findings of fact and conclusions of law. The charge in paragraph 14 that Respondents dispense excessive or inappropriate quantities of legend drugs is equivalent to charges in Count Two against Rx and Count Four against Gordon. Facts relevant to those charges are alleged in paragraphs 9, 15, 16, 17, and 20 through 22 of the Administrative Complaints. Paragraphs 25, 26, and 29 in the Administrative Complaint against Rx allege additional relevant facts, as do paragraphs 26, 27, and 30 in the Administrative Complaint against Gordon. In relevant part, paragraph 9 alleges that on October 5, 2001, Respondents received 764 prescriptions from three physicians identified in the record as Drs. Rosenkrantz, Rivera, and Thompson. Paragraphs 15 through 17 allege that two drugs marketed under the names Phentermine and Bontril are controlled substances that have a high potential for abuse. Respondents stipulated to paragraphs 15 through 17. Paragraph 20 alleges that many of the controlled substances are for a three-months' supply per purchase. Paragraph 21 alleges that the PDR states that tolerance for the anorectic effect of many obesity drugs occurs after a "few weeks," and that the drug should be discontinued at that time rather than increased to overcome tolerance. Paragraph 22 alleges that Respondents filled hundreds of prescriptions for obesity drugs each day included in the business practices described in paragraphs 1 through 21. The business practices described in paragraphs 1 through 21 are for the dates that occurred from October 5 through 18, 2001. Paragraphs 25 and 26 pertaining to Rx, and paragraphs 26 and 27, pertaining to Gordon, allege that Petitioner's investigator obtained the written record of additional prescriptions when an employee for Rx produced the documents on October 24, 2001. Paragraph 29, pertaining to Rx, and paragraph 30, pertaining to Gordon, allege that the computer operated by Rx showed that Rx and its employees dispensed 17,410 tablets of Phentermine on December 5, 2001; and that a daily log dated September 4, 2001, showed that Rx employees received 300 prescriptions from Dr. Rivera. The facts alleged to support the charges of dispensing excessive or inappropriate quantities of legend drugs involve dates from September 4 through December 6, 2001 (the relevant period). Within the relevant period, the enumerated paragraphs together allege that Rx and Gordon dispensed excessive and inappropriate quantities of legend drugs including: hundreds each day; 17,410 tablets on December 5, 2001; and 300 from Dr. Rivera on September 4, 2001. The relevant paragraphs also allege that many of the legend drugs were obesity drugs such as Bontril and Phentermine; and that many drugs were dispensed pursuant to prescriptions for 90 days' supply per purchase. The relevant paragraphs further allege methods of proof, including documents received on October 24, 2001, provisions of the PDR, and documents collected by the inspectors. The evidence is less than clear and convincing that Gordon personally dispensed drugs during the relevant period. There is insufficient evidence, or allegations, to show when Gordon was present at the pharmacy, for how long, or if her duties required her to fill prescriptions and dispense drugs. The evidence is less than clear and convincing that Gordon is vicariously responsible for drugs that others dispensed during the relevant period. Although the evidence is clear that drugs were dispensed in a persistent and practiced manner, there is insufficient evidence for the trier of fact to draw an inference that Gordon was vicariously responsible. Petitioner did not prove that Gordon was the only manager during the relevant period. Paragraph 5 of the Administrative Complaints alleges that, on October 18, 2001, Gordon identified another person present at the pharmacy as the owner. The next allegations concerning Gordon's management control over pharmacy operations pertain to the inspection conducted on January 31, 2002. The allegations and evidence are insufficient to differentiate the duties of Gordon and others with management control. The evidence is insufficient to show which days various managers were present, what specific duties each performed, and how the managers allocated management responsibilities among themselves. The evidence is less than clear and convincing that Gordon had any management control over those who dispensed medications during the relevant period. There is no doubt that Rx dispensed large quantities of medication during the relevant period. Employees at Rx dispensed approximately 1,942 legend drugs during the relevant period. That is a practiced and persistent manner of dispensing drugs regardless of which employees dispensed the drugs. Large quantities of drugs are not necessarily excessive or inappropriate quantities. Petitioner stipulated during the hearing that a determination of whether quantities are excessive or inappropriate must be made "per patient" and not by reference to the pharmacy. The evidence of prescriptions filled by Rx consists of Petitioner's Exhibits 59, 62, 63, 76, 77, 87, 88, 90, 92, and 94 (P59, P62, etc.). The prescriptions were filled from January 11, 2001, through April 26, 2002. Prescriptions evidenced in P87, P88, and P92 are outside the relevant period. Of the remaining prescriptions, the prescriptions that are essential to the opinion of Petitioner's expert are set forth in P94. That exhibit consists of a Site Fill List, or daily log, maintained by Rx for the period from September 4 through October 10, 2001. Petitioner's expert identified 102 instances in P94 in which he opined that medications were dispensed to individual patients in excessive or inappropriate quantities. The instances relied on by Petitioner's expert may be fairly summarized as follows: Item Date Patient Drug Dose/Quantity 1. 9/20 L.A. Phentermine(P) 30mg/30 2. 9/20 L.A. P 30mg/30 3. 9/20 L.W. P 30mg/90 4. 9/20 L.W. Meridia (M) 15mg/90 5. 9/4 K.Co. Diethylpropion(DP) 75mg/90 6. 9/4 K.Cu P 30mg/90 7. 9/10 A.J. Adipex (A) 37.5mg/90 8. 9/10 A.J. Didrex (D) 50mg/30 9. 9/10 A.J. Adipex (A) 37.5mg/90 10. 9/10 A.J. Didrex (D) 50mg/30 11. 9/11 D.B. Bontril (B) 105mg/90 12. 10/2 D.B. B 105mg/90 13. 10/2 K.Sg. P 15mg/90 14. 10/1 K.Sg. P 30mg/90 15. 9/4 I.To. P 30mg/30 16. 9/26 I.To. P 37.5mg/90 17. 10/1 I.Tr. A 37.5mg/90 18. 10/5 I.Tr. A 37.5mg/90 19. 10/3 I.Tr. Celebrex 200mg/50 20. 10/5 I.Tr. Xenical 120mg/270 21. 9/10 D.Ha. A 37.5mg/90 Item Date Patient Drug Dose/Quantity 22. 9/6 D.Ha. P 30mg/90 23. 10/10 J.H. M 10mg/30 24. 10/5 J.H. P 30mg/90 25. 9/6 D.Ht. D 50mg/30 26. 9/7 D.Ht. D 30mg/30 27. 9/28 L.M. Viagra 100mg/30 28. 9/28 L.M. Viagra 100mg/30 29. 9/5 J.S. P 30mg/30 30. 9/24 J.S. P 30mg/30 31. 10/1 J.S. P 30mg/90 32. 9/25 Z.H. P 30mg/30 33. 9/25 Z.H. P 30mg/30 34. 9/5 D.I. A 37.5mg/30 35. 9/6 D.I. A 37.5mg/30 36. 10/10 L.Z. D 50mg/90 37. 10/8 L.Z. P 30mg/90 38. 9/17 T.W. A 37.5mg/30 39. 9/14 T.W. P 37.5mg/90 40. 9/20 L.A. P 30mg/30 41. 9/20 L.A. P 30mg/30 42. 9/17 A.E. P 30mg/30 43. 9/24 A.E. P 30mg/90 44. 9/27 D.P. A 37.5mg/90 45. 9/26 D.P. P 30mg/90 46. 10/5 K.Sh. A 37.5mg/30 47. 10/5 K.Sh. P 37.5mg/30 48. 10/5 P.S. P 30mg/90 49. 9/27 P.S. P 37.5mg/30 50. 9/10 M.F. P 30mg/90 51. 9/10 M.F. P 30mg/90 52. 9/24 A.G. A 37.5mg/30 53. 9/6 A.G. B 105mg/30 54. 9/4 B.A. DP 75mg/30 55. 9/4 B.A. DP 75mg/30 56. 9/17 M.S. P 37.5mg/90 57. 9/20 M.S. P 37.5mg/90 58. 10/9 V.S. P 30mg/90 59. 9/24 V.S. P 37.5mg/90 60. 9/17 D.Cd. P 37.5mg/90 61. 9/4 D.Cf. P 37.5/90 62. 9/26 J.Ws. P 30mg/90 63. 9/27 J.Ws. P 37.5mg/90 64. 9/25 R.R. B 105mg/30 65. 9/24 R.R. B 105mg/90 66. 9/10 A.J. A 37.5mg/90 Item Date Patient Drug Dose/Quantity 67. 9/10 A.J. D 50mg/30 68. 9/28 K.J. P 30mg/90 69. 10/1 K.J. P 30mg/90 70. 9/12 S.F. P 30mg/30 71. 9/12 S.F. P 30mg/30 72. 10/3 S.F. P 30mg/30 73. 10/3 D.M. A 37.5mg/30 74. 10/5 D.M. A 37.5mg/30 75. 9/14 P.G. DP 75mg/30 76. 9/14 P.G. DP 75mg/90 77. 9/17 M.I. P 30mg/30 78. 9/21 M.I. P 30mg/90 79. 9/19 T.H. Viagra 100mg/20 80. 9/18 T.H. Viagra 100mg/30 81. 9/12 C.C. Ionamin (I) 30mg/90 82. 9/5 C.C. P 37.5mg/30 83. 9/21 M.P. D 50mg/30 84. 9/25 M.P. D 50mg/90 85. 9/4 K.H. A 37.5mg/30 86. 9/28 K.H. A 37.5mg/30 87. 10/10 K.H. A 37.5mg/30 88. 10/3 A.C. Viagra 100mg/10 89. 10/3 A.C. Viagra 100mg/10 90. 9/24 K.K. P 37.5mg/30 91. 10/2 K.K. P 37.5mg/90 92. 9/6 J.Wi. A 37.5mg/30 93. 9/19 J.Wi. D 37.5mg/30 94. 9/5 T.W. A 37.5mg/30 95. 9/19 T.W. A 37.5mg/30 96. 10/8 T.W. A 37.5mg/30 97. 9/28 A.M. P 30mg/30 98. 10/9 A.M. P 30mg/30 99. 9/17 S.K. Viagra 100mg/10 100. 9/17 S.K. Viagra 100mg/10 101. 10/5 C.K. Ultram 50mg/30 102. 10/8 C.K. ULtram 50mg/90 The appropriateness of a quantity of medication is determined by reference to the medical profile of a particular patient. The evidence is less than clear and convincing that the quantities of dispensed medication were inappropriate. Evidence and allegations concerning patient profiles are inconsistent. Petitioner alleges in its complaints that information in patient profiles provided an insufficient basis for the prescribing physician to order medication. However, witnesses for Petitioner opined that Respondents deviated from the professional practice of pharmacy by failing to consult the profiles. The necessary implication is that the profiles contained sufficient medical information for Respondents to consult before dispensing medication. There would be no rational reason to consult an invalid patient profile. Other evidence suggests the patient profiles contain insufficient medical information. The apparent inconsistency was confusing, contributed to a hesitance in the mind of the trier of fact that either proposition was true, and eroded the credibility of expert testimony that Rx employees dispensed medication in inappropriate quantities to particular patients. A medication is dispensed in an excessive quantity if the quantity dispensed exceeds the maximum recommended quantity for the medication. Petitioner cited no statute or rule that defines the term "quantity." The plain and ordinary meaning of the "quantity" of a drug is the "measurable [or] countable . . . property" of the drug. The American Heritage Dictionary of the English Language, 1432 (4th ed. 2000). The trier of fact measured the total medication dispensed pursuant to a single prescription by the total milligrams of medication dispensed. Rx employees dispensed obesity drugs evidenced in P94 in the form of pills. The total medication dispensed by pill is a mathematical product equal to the strength of each pill multiplied by the number of pills, including refills. The evidence is less than clear and convincing that prescriptions in P94 included refills. Petitioner cited no statute or rule that identifies the maximum recommended quantity for the obesity drugs at issue. Rather, a combination of expert testimony and the maximum strengths evidenced in P94 establish a maximum recommended quantity for the obesity drugs at issue. The trier of fact determined that obesity drugs in P94 were dispensed in excessive quantities if the total medication dispensed to a patient within 90 days exceeded the total medication in 90 pills, at the maximum strength for each pill, taken once a day for 90 days (the 90-day standard). Evidence of which obesity drugs have a lower quantity standard is less than clear and convincing. It is clear, however, that any of the obesity drugs in P94 are dispensed in excessive quantities if the total dispensed medication exceeds the total medication in the 90-day standard. The evidence is less than clear and convincing that the total dispensed medication was excessive in item numbers 1, 2, 7 through 10, 40, 41, 66, and 67. Items 1, 2, 40, and 41 may be duplicates as may be the case for items 8, 10, and 67; and 7, 9, and 66. The trier of fact has sufficient doubt as to whether the opinions based on the enumerated items are true. The evidence is less than clear and convincing that the total dispensed medication was excessive in items 19, 20, 27, 28, 79, 80, 88, 89, and 99 through 102. Those items show that the medications are not obesity drugs. Evidence of the quantity standards for legend drugs other than obesity drugs is less than clear and convincing. The evidence is less than clear and convincing that total dispensed medication was excessive in connection with items 5, 6, 25 and 26, 32 through 35, 46 and 47, 52 through 55, 60, 61, 70 through 74, 85 through 87, and 92 through 98. Patient names in items 5 and 6 and 60 and 61 are different. Where patient names are the same for two prescriptions, the total medication dispensed pursuant to both prescriptions does not exceed the 90-day standard. The evidence is clear and convincing that the total dispensed obesity medication exceeded the 90-day standard in several instances. Those instances are evidenced in items 3 and 4, 11 through 18, 21 through 24, 29 through 31, 36 through 39, 42 through 45, 48 through 51, 56 through 59, 62 through 65, 68 and 69, 75 through 78, 81 through 84, and 90 and 91. Neither the strength of each pill nor the number of pills dispensed pursuant to a single prescription caused total dispensed medication to exceed the total medication in the 90- day standard. Total dispensed medication generally exceeded total medication in the 90-day standard when employees dispensed an obesity drug to a patient pursuant to a second prescription within 90 days of the first. In items 29 through 31, however, the excess occurred when obesity drugs were dispensed pursuant to a third prescription in item 31 within 90 days of the first two prescriptions in items 29 and 30. Therefore, the 49 items enumerated in the preceding paragraph evidence only 24 instances of excessive quantities of obesity drugs. The total dispensed medication exceeded the total medication in the 90-day standard in three types of fact patterns. In one fact pattern, Rx employees dispensed the same brand name obesity drug to a patient at the maximum strength pursuant to two prescriptions within 90 days. In item 11, for example, Rx employees dispensed 90 pills of Bontril at the maximum strength of 105 milligrams per pill. In item 12, they dispensed the same quantity approximately 22 days later. The total dispensed medication within 90 days is equal to the product of 180 pills multiplied by 105 milligrams, or 18,900 milligrams. The total medication in the 90-day standard is 90 pills at 105 milligrams, or 9,450 milligrams. The excessive quantity is the excess of the dispensed medication (18,900) over the medication in the 90-day standard (9,450). The excessive quantity evidenced in items 11 and 12 is 9,450 milligrams. By similar calculations, the excessive quantity in items 56 and 57 is 3,375 milligrams. The excessive quantity in items 64 and 65 is 3,150 milligrams. In items 75 and 76, 83 and 84, and 90 and 91, the excessive quantities are 2,250, 1,500, and 1,125 milligrams, respectively. In the second fact pattern, Rx employees dispensed the same brand name obesity drug to a patient at less than the maximum strength pursuant to two or more prescriptions within 90 days. In item 14, for example, Rx employees dispensed 90 pills of Phentermine at a strength of 30 milligrams per pill. In item 13, they dispensed 90 pills of the same drug the next day at 15 milligrams per pill. The total medication dispensed within 90 days is equal to the sum of the total milligrams dispensed in each instance, or 4,050 milligrams. The total medication in the 90-day standard is 90 pills at 37.5 milligrams, or 3,375 milligrams. The excessive quantity is the excess of the dispensed medication (4,050) over the medication in the 90-day standard (3,375). The excessive quantity evidenced in items 13 and 14 is 675 milligrams. By similar calculations, the excessive quantities in items 15 and 16, 29 through 31, 42 and 43, 48 and 49, 50 and 51, 58 and 59, 62 and 63, 68 and 69, and 77 and 78, respectively, are 900, 1,125, 225, 450, 2,025, 2,700, 2,700, 2,025, and 225 milligrams. In the third fact pattern, Rx employees dispensed different brand name obesity drugs in different strengths pursuant to two prescriptions within 90 days. In item 3, for example, Rx employees dispensed 90 pills of Phentermine at 30 milligrams per pill. In item 4, they dispensed 90 pills of Meridia on the same day at 15 milligrams per pill. The total medication dispensed within 90 days is equal to the sum of the milligrams dispensed in each instance, or 4,050 milligrams. The total medication in the 90-day standard is 90 pills at 37.5 milligrams, or 3,375 milligrams. The excessive quantity is the excess of the dispensed medication (4,050) over the medication in the 90-day standard (3,375), or 675 milligrams. By similar calculations, the excessive quantities in items 21 through 24, 36 through 39, 44 and 45, and 80 and 81, respectively, are 2,975, 1,575, 2,700, and 450 milligrams. Rx employees dispensed obesity drugs in the three fact patterns just discussed in an aggregate excessive quantity of 42,275 milligrams. The average excessive quantity for each of the 24 instances found in P94 is 1,761 milligrams. The average excess quantity correlates to a 90-day excess of approximately 17 pills at a maximum strength of 105 milligrams, 23 pills at 75 milligrams, 35 pills at 50 milligrams, 47 pills at 37.5 milligrams, and 117 pills at 15 milligrams. The ALJ has concluded that Section 465.016(1)(i) creates a legal presumption that the excessive quantities of obesity drugs dispensed by Rx employees were not dispensed in the course of the practice of pharmacy. Rx did not rebut the statutory presumption with persuasive evidence that explains the quantities of medications dispensed or rebuts the quantity standards in evidence. Respondents' expert relied on substantially the same evidence as that relied on by Petitioner's expert and opined that Respondents dispensed medication in accordance with the professional practice of pharmacy. However, that opinion was an ultimate conclusion that was not fact specific and did not cast doubt on the details that gave rise to the statutory presumption. That opinion was not persuasive. Rx argues that Petitioner did not show that the prescriptions were actually filled, did not sufficiently identify the patients, and did not show that the patients actually received the medications. Those arguments are neither credible nor persuasive. They do not create a hesitance in the mind of the trier of fact concerning the details supporting the statutory presumption. Information in P94 is part of the QS1 system. The instances of excessive quantities of medications provide a sufficient basis for the trier of fact to find that Rx is vicariously liable for Rx employees who dispensed obesity drugs in excessive quantities in the 24 instances evidenced in P94. The instances are not isolated events. During the 26 days evidenced in P94, the 24 instances of excessive quantities occurred, on average, almost once a day. That evidence shows that Rx employees dispensed excessive quantities of obesity drugs in a persistent and practiced manner. Rx did not require its employees to comply with the standard of conduct evidenced in expert testimony. In the absence of an adequate alternative, Rx employees must personally review site fill lists to ensure that quantities are not excessive. Rx employees do not personally review site fill lists. Rather, Rx permits its employees to rely on the QS1 computer system for that and other purposes. Reliance on the QS1 computer system was reasonable and was made in good faith. The QS1 is a computer system commonly utilized by pharmacies. The system maintains inventory, patient profiles, and patient addresses and phone numbers. The QS1 system enables Rx to capture and monitor patient profiles in dispensing medications. The evidence is less than clear and convincing that the information in the patient profiles is inaccurate or inadequate. Rx employees enter a prescription into the QS1 system and then retrieve the prescribed medication from inventory. If the medication has not been pre-packed, the employee counts the medication and places it in a vial. If the medication has been pre-packed, Rx labels the medication. The QS1 system alerts Rx employees to any particular problems that a patient may have as a result of the prescribed medication. If an Rx employee receives an alert, she or he reviews the patient profile and resolves the problem. Once the prescription is prepared for dispensing, Rx pharmacists compare the prescription with the vial label to ensure accuracy. Rx employees then place the medication in an envelope for shipping but do not actually ship the medication until they receive a signed copy of the daily log from the prescribing physician verifying that the physician has not prescribed medication in excessive quantities. The daily log is not a prescription but is an extra step taken by Rx to ensure the accuracy of the order for medication. The QS1 system performed its purpose well when measured by statistical standards. There are approximately 1,942 prescriptions listed in P94. Only 24 of those were for excessive quantities of obesity drugs. The QS1 system achieved an error rate of approximately 1.23 percent. That rate of error, however, produced excessive quantities of medication almost once a day for 26 days. Rx relied on the QS1 system in filling approximately 154,773 prescriptions between October 19, 2001, and April 26, 2002. If the QS1 system were to maintain an error rate of 1.23 percent during that period, the mathematical probability is that Rx would have dispensed excessive quantities of medication in 1,903 instances over approximately 190 days for an average of approximately 10 instances a day. If the excess quantity in each instance were equal to 1,761 milligrams, according to the average determined in paragraph 76 of the Findings of Fact, Rx would have dispensed 17,644 milligrams of excess medication each day and 3,352,429 milligrams of excess medication in 190 days. An error rate of 1.23 percent represents a significant potential for harm. However, the evidence of actual harm is less than clear and convincing. Rx dispensed excessive quantities of obesity drugs in 24 instances evidenced in P94. Rx dispensed the medication irrespective of whether the patients actually received it. Receipt is a relevant inquiry to determine harm to an identified recipient. Receipt does not determine whether Rx employees dispensed obesity drugs from the pharmacy. The grounds alleged in paragraphs 15 through 17 are not disputed. Paragraph 18 alleges, in relevant part: The concept of dispensing . . . scheduled drugs by permitting them to be specifically requested and 'ordered' over the internet is a potentially dangerous method of allowing . . . medications to be 'taken on the user's own initiative rather than on the basis of professional medical advice. ' Dispensing controlled . . . drugs in this manner by Respondent[s] runs contrary to the spirit, intent, and purpose of chapter 893 with regard to protecting the safety of the public. (emphasis supplied) No findings are made concerning the grounds alleged in paragraph 18. The trier of fact cannot discern what specific acts or omissions paragraph 18 alleges. Paragraph 18 implies that Respondents somehow transformed a "concept" into a "method" but does not allege any specific acts or omissions by which Respondents effectuated the transformation. Paragraph 18 is devoid of patient names, dates, specific transactions, details, and other allegations of essential facts. Several allegations in paragraphs 19 through 21 concern the "Physician's Desk Reference" (PDR). Other than those findings already made, the trier of fact is uncertain what Petitioner intends to allege in paragraphs 19 through 21. The PDR is a method of proving a fact not alleged. Evidence of the legal effect of the PDR in this proceeding is less than clear and convincing. Petitioner failed to sufficiently evidence the specific standards allegedly enunciated in the PDR. The allegation is that the PDR states that obesity drugs should be discontinued within a "few weeks." Petitioner failed to define a "few weeks" with clear and convincing evidence as any period less than 90 days. The remaining grounds alleged in paragraphs 19 through 21 recite or paraphrase provisions of the PDR. No further findings are made concerning paragraphs 19 through 21. Petitioner proved the allegation in paragraph 22 that Rx dispensed hundreds of medications each day from October 5 through 18, 2001. Petitioner did not prove the remaining grounds alleged in paragraph 22. For reasons stated in paragraphs 9 through 11 of the Findings of Fact, evidence of the allegation in paragraph 22 that prescribing physicians wrote and submitted prescriptions based solely on information received from Internet questionnaires is less than clear and convincing. Information included in the Internet questionnaires is not established by the requisite standard of proof. No finding is made concerning the grounds alleged against Rx in paragraphs 23 through 24 or those alleged against Gordon in paragraphs 23 through 25. Petitioner concedes in its PRO at pages 27 through 28 that Petitioner did not prove grounds supporting the charges that: Respondents failed to report violators to Petitioner; and used USAP to promote or advertise the use or sale of controlled substances. Petitioner proved the grounds alleged against Rx in paragraphs 25 and 26 and those alleged against Gordon in paragraphs 26 and 27. Respondents produced the written record of prescriptions requested by the inspector. Respondents conferred with their attorney before producing the documents. The grounds alleged in paragraphs 27 through 36 against Rx and in paragraphs 28 through 37 against Gordon pertain to an inspection conducted by Petitioner on December 6, 2001. Petitioner proved some of the grounds alleged against Rx in paragraphs 27 and 28 and some of those alleged against Gordon in paragraphs 28 and 29. The evidence shows that Gordon was not present at the pharmacy during the inspection on December 6, 2001. The evidence is less than clear and convincing that Gordon worked at the pharmacy that day. The evidence is insufficient to prove that Gordon committed the acts or omissions alleged in paragraphs 28 through 31 or that the acts or omissions of others were so persistent and practiced during that period that Gordon was vicariously responsible for their acts or omissions. Petitioner proved some of the grounds alleged against Rx in paragraph 27. When the inspector first arrived, two technicians and an administrator were visible to the inspector. Two pharmacists greeted the inspector within 15 minutes of his arrival at Rx. No sign was posted that the pharmacists were out to lunch or on break. The evidence is less than clear and convincing that both pharmacists were out to lunch or on break. One of the pharmacists may have been in the bathroom or otherwise available for questions from technicians. Respondents argued during the hearing that legislation identified in the record as the "potty bill" carves out an exception to the requirement to post a sign when a pharmacist goes to the bathroom. Although the argument does not evidence the "potty bill," the argument creates sufficient doubt in the mind of the trier of fact concerning the issue of whether both pharmacists were out to lunch. Evidence of the whereabouts of the second pharmacist is less than clear and convincing. Evidence defining the term "[l]ater" is less than clear and convincing. Petitioner failed to prove the allegations in paragraph 28 that a technician was working "alone" or was "unsupervised." If it were found that Rx committed the charged violation, there would be no potential or actual harm. The requirement for a sign has little meaning for an Internet pharmacy such as Rx. The testimony of several witnesses for Petitioner makes clear that Rx is not open to patients who physically walk into the pharmacy and present written prescriptions. The front door is frequently locked. At least one investigator had to knock on the front door to gain access. Patients who fill their prescriptions at Rx "walk in" electronically and are unable to read any sign posted inside the pharmacy. The only persons who would benefit from such a sign would be those employed at the pharmacy. More likely than not, Rx employees do not need a sign to tell them a pharmacist is not in the same room with them. The evidence is less than clear and convincing that Rx employees failed to properly label drugs on December 6, 2001. The plain terms of paragraph 28 admit that Rx complied with all but one of the labeling requirements in Rule 64F-12.006(1)(a) by ensuring that its employees place pills in vials labeled with all of the requisite information except dosage form. The evidence is less than clear and convincing that the labels did not include dosage form. The evidence is less than clear and convincing that Rx placed the labeled vials with "unsigned prescriptions." Rather, the preponderance of evidence shows that the unsigned documents are the written record of electronic prescriptions and not unsigned written prescriptions. Petitioner proved the allegations against Rx in paragraph 29. The dates alleged in paragraph 29 are included in previous findings that Rx dispenses large numbers of medications ordered by Drs. Rosenkrantz, Rivera, and Thompson. Petitioner did not prove substantially similar allegations against Gordon in paragraph 30. Petitioner did not prove the allegations in paragraph 30 and 31 that Rx and Gordon knowingly possessed mislabeled drugs. The evidence is less than clear and convincing that Rx employees possessed mislabeled drugs or, if so, that Rx or Gordon are vicariously responsible for that deficiency. The grounds alleged to have occurred on December 6, 2001, are not supported by the quantum or quality of evidence that supports the finding of mislabeled drugs on October 18, 2001. Evidence of grounds arising from the inspection on December 6, 2001, primarily consists of the testimony of one inspector and three exhibits. The photographs in evidence pertain to the inspection conducted on October 18, 2001. Petitioner's experts relied on those photographs, in relevant part, in rendering their opinions concerning allegations that Rx knowingly possessed mislabeled drugs. Expert opinions are unnecessary to assist the trier of fact in determining whether Rx possessed mislabeled drugs on any date. The trier of fact is capable of making that determination based on the standards enunciated in the applicable rules, the testimony of the fact witnesses, and the pictures and documents that support their testimony. Grounds alleged against Rx in paragraphs 31-36, and those alleged against Gordon in paragraphs 32-37, arise from a re-inspection conducted on January 31, 2002. Like the evidence pertaining to the inspection on December 6, 2001, grounds arising from the inspection on January 31, 2002, are not supported by the quantum or quality of evidence that supports the inspection of October 18, 2001. Petitioner must prove the grounds arising from each inspection by clear and convincing evidence. The trier of fact cannot draw an inference from the findings pertaining to October 18, 2001, to bolster the evidence submitted for the other inspections. If it were found that evidence concerning each inspection satisfied the clear and convincing standard of proof, it would be appropriate for the trier of fact to consider all of the inspections in determining whether the alleged deficiencies were so persistent and practiced that they supported an inference of vicarious responsibility. The evidence is less than clear and convincing that the alleged grounds arising from the inspection on January 31, 2002, are true. The preponderance of evidence shows a bin containing unlabeled vials of medication was on top of a counter on one side of a room in the pharmacy. On the other side of the room, all of the medication vials and bins were labeled. The medication in the bin by itself was separated from medication in the pharmacy's active stock. Bins of medication containing active stock were labeled. It is unlikely the separated medication would be inadvertently dispensed. Medication in the separated bin was not labeled because it was being returned to the manufacturer. Respondents did not hold medication in the separated bin to be dispensed. The grounds alleged against Rx in paragraphs 37 through 65 and against Gordon in paragraphs 38 through 65 pertain to complaints filed by T.M. and J.W. For convenience, a finding pertaining to the cited paragraphs may contain references to more than one paragraph. References to a lower numbered paragraph, or group of paragraphs, refer to the grounds alleged against Rx. References to a higher numbered paragraph, or group of paragraphs, refer to grounds alleged against Gordon. Petitioner proved the grounds alleged in paragraphs 37 (against Rx) and 38 (against Gordon). Petitioner proved some of the grounds alleged in paragraphs 38 through 48 and 39 through 49 and portions of the grounds alleged against Rx in paragraph 52. On October 21, 2001, T.M. opened an e-mail from USAP and responded with information about her. T.M. purchased 90 tablets of Phentermine and paid $169 to USAP by credit card. T.M. subsequently returned the medication and received a refund. T.M. received the medication by overnight delivery. The vial label indicated Rx dispensed the medication. The label listed Dr. Rivera as the prescribing physician. T.M. never saw Dr. Rivera or heard of Rx or Gordon before receiving the medication. T.M. did not choose Rx as a pharmacy and did not choose Gordon as a pharmacist. T.M. attempted to return the medication for a refund. T.M. spoke by telephone to a representative of USAP. The representative denied T.M.'s request for refund. T.M. telephoned Rx at the number provided on the prescription label. T.M. spoke to a female who identified herself as a pharmacist and answered with a heavy accent. It is not clear that Gordon has a heavy accent. T.M. had no technical questions of the medication dispensed by Rx. The pharmacist stated that she could not help T.M. with her refund and referred T.M. back to USAP. The remaining testimony of T.M. is less than clear and convincing. On cross examination, T.M. distinctly recalled few, if any, facts. Her testimony was neither precise nor specific. T.M. was confused as to material facts in issue. Petitioner failed to prove the remaining grounds alleged in paragraphs 38 through 48 and 39 through 49. The ALJ ruled that evidence of the statements made in the USAP website is hearsay and that Sections 120.57(1)(c) and (l) prohibit the trier of fact from basing a finding on anything less than competent and substantial evidence. There is less than clear and convincing evidence that the website does not afford patients a choice in pharmacies. If it were found that the USAP website failed to offer a choice of pharmacies, the evidence is less than clear and convincing that Respondents knowingly participated in a system that does not afford a choice in pharmacies. USAP is located in the same building that Rx occupies at 5400 University Drive. Any further findings would require the fact-finder to draw an inference based on insufficient evidence. The evidence is less than clear and convincing that Rx controls the operations of USAP; that Rx and USAP are sibling or related companies, or share common officers, managers, directors, or employees; or that Rx has any legal or actual influence in the management or operation of USAP. The evidence is less than clear and convincing that Respondents had editorial control or input into the content and operation of the website used by USAP in the conduct of USAP's business; or that Respondents knew the content of the website. For similar reasons, evidence of the grounds alleged in paragraphs 53 through 65 concerning the content of the USAP website is less than clear and convincing. Petitioner failed to prove the grounds in paragraphs 43 and 44 alleging that the obesity medication prescription for T.M. was not written within the course of the professional practice of medicine. The prescriptions were not written. Petitioner failed to prove the grounds alleged in paragraphs 49 through 51 and 50 through 52. Operative terms in Section 893.02(20) apply to a pharmacist and not to a pharmacy. A pharmacist and a pharmacy are defined separately in Section 465.03(10) and (11). Section 893.02(20) does not require a pharmacy, including Rx, to make any determination regarding the validity test defined in paragraph 42 of the Findings of Fact. Section 893.02(20) requires Gordon to apply the validity test only if Gordon receives a prescription ordered by a physician licensed in a state other than Florida. While the statute necessarily requires Gordon to determine the state in which the prescribing physician is licensed before Gordon can know whether to apply the validity test, the evidence is less than clear and convincing that Gordon failed to perform her statutory duty. Petitioner did not submit any competent substantial evidence that Drs. Rosenkrantz, Rivera, and Thompson are licensed in a state other than Florida. Sufficient evidence of the statutory prerequisite to the charged violation is missing from the record. The prescriptions evidenced in P92 list a Florida address for Drs. Rosenkrantz and Rivera and a Missouri address for Dr. Thompson. It may be reasonable for the fact-finder to infer that the physicians are licensed in the state where they are located, but such an inference is less than clear and convincing. If Drs. Rosenkrantz and Rivera were licensed in Florida, Section 893.02(20) would impose no statutory duty on Gordon concerning their prescriptions. Dr. Thompson is not licensed in Florida. It is unclear that Dr. Thompson is licensed in a state other than Florida. Sufficient evidence of the statutory prerequisite to the charged violation is missing from the record. If it were found that Drs. Rosenkrantz, Rivera, and Thompson are licensed in a state other than Florida, the evidence is less than clear and convincing that Gordon failed to correctly apply the validity test prescribed in Section 893.02(20). Before employees of the pharmacy managed by Gordon dispensed any medications ordered by these physicians, the employees required each physician to sign a site fill list, or daily log, verifying the validity of the professional relationship, the authenticity of the prescription, and the medical necessity for the drugs. An unwritten agency statement prohibits Gordon from dispensing any controlled substance pursuant to a prescription transmitted by a physician who has not conducted an in-person examination of the patient. The unwritten agency statement requires Gordon to determine whether the physician has conducted an in-person examination regardless of the state in which the physician is licensed. It is clear from the record that Drs. Rosenkrantz, Rivera, and Thompson did not physically examine their patients prior to ordering the prescriptions evidenced in P92. Drs. Rosenkrantz, Rivera, and Thompson transmitted substantially all of the prescriptions evidenced in P92. The prescriptions list Florida addresses for Drs. Rosenkrantz and Rivera and a Missouri address for Dr. Thompson. The prescriptions are for patients located in more than 36 states and the District of Columbia. By negative proof, three prescribing physicians in Florida and Missouri could not have physically examined all of the patients in a single day. For purposes of continuity, further findings regarding the agency statement are made in the Conclusions of Law. Petitioner failed to prove the allegations in paragraphs 64 and 65 that Respondents engage in a fee splitting, commission, kickback, rebate, or split fee arrangement with USAP. Standards defining the prohibited arrangement are not defined clearly and convincingly. No evidence shows that Gordon receives anything from USAP or pays anything to USAP. Rx and USAP are located in the same building and maintain a business relationship. USAP pays Rx a fee for filling prescriptions plus any costs incurred by Rx. USAP pays Rx the costs of each prescription filled plus a fee of either $5 or $10 for each prescription. From October 19, 2001, through January 18, 2002, Rx filled approximately 66,217 prescriptions and billed USAP approximately $584,460 for fees, exclusive of costs. From January 25 through April 26, 2002, Rx filled approximately 88,556 prescriptions and billed USAP approximately $416,100 for fees, exclusive of costs. The evidence is less than clear and convincing that Rx paid any amount to USAP for referring patients to Rx or otherwise. The evidence is less than clear and convincing that USAP paid Rx for anything other than the costs incurred and services performed in filling prescriptions.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding Gordon not guilty of the allegations in the two administrative complaints against her; Rx guilty of violating Section 465.016(1)(i); imposing an administrative fine of $24,000 for the 24 instances of dispensing excessive quantities of controlled substances; placing Rx on probation for one year, subject to the condition that Rx utilize personal review or some other system adequate to prevent its employees from dispensing excessive quantities of controlled substances; and requiring Rx to pay the costs directly related to that part of the investigation and prosecution required to prove that Rx dispensed excessive quantities of controlled substances. DONE AND ENTERED this 10th day of January, 2003, in Tallahassee, Leon County, Florida. DANIEL MANRY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 10th day of January, 2003. COPIES FURNISHED: Rosanna M. Catalano, Esquire David Herman, Esquire John Raymaker, Esquire Bureau of Practitioner Regulation - Legal Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Sean M. Ellsworth, Esquire Mark A. Dresnick, Esquire Monica L. Felder, Esquire Dresnick, Ellsworth & Felder, P.A. 201 Alhambra Circle Sun Trust Plaza, Suite 701 Coral Gables, Florida 33134-5108 John Taylor, R.Ph., Executive Director Board of Pharmacy Department of Health 4052 Bald Cypress Way, Bin C-04 Tallahassee, Florida 32399-1701 S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701
Findings Of Fact At all times pertinent to the allegations involved in this hearing, Respondent, Robert A. Lieberman, was licensed to practice medicine in the State of Florida. John P. Spanogle, an investigator with the Department of Professional Regulation since 1980 and with the Board of Medical Examiners prior to that back to 1975, in November, 1979, was requested by representatives of the Orlando Florida Police Department to work with their detectives in several ongoing drug investigations. Respondent was not the subject of any of those particular Orlando Police Department investigations. However, during the course of these investigations, Mr. Spanogle secured certain prescriptions for Class II controlled substances that were written by the Respondent. As a result of these prescriptions, Mr. Spanogle interviewed the Respondent on July 7, 1982, at Respondent's office. At the outset of the interview, Mr. Spanogle advised Respondent of the nature of the allegations and of his rights regarding being questioned. He found Respondent to be extremely cooperative and received full answers to the questions asked, as well as patient release forms and patient records as to the patients listed in the various counts of the Administrative Complaint. During the course of the interview, Mr. Spanogle and Dr. Lieberman discussed several of the doctor's patients and the prescriptions he had written for them over the period in question. Dr. Lieberman seemed surprised he had prescribed so many Percodan and other drugs and could not readily explain why he had written so many prescriptions. Only one of the doctor's former patients testified for the Petitioner at the hearing. This was Linda Gorsuch Creed, a/k/a Linda Clary Morgan, the individual described in Count I of the Administrative Complaint. Ms. Creed is a former drug abuser who started abusing drugs when she was 18 years of age. She is now 26. During the course of her drug abuse, she used such substances as heroin, Dilaudid, Demerol, and others, injecting them into her arms and hands. She first saw Respondent in early 1979 for the purpose of securing drugs. Dr. Lieberman did not know this, however, because her stated complaint was of not being able to have sex without pain. This, however, was false. During the first visit, she was examined by the Respondent and was nude except for the examination gown. She cannot state whether she had drug injection track marks on her arms, but imagines she did since she was using drugs at the time. She does not know whether Respondent saw them, if in fact she had them. Respondent denies noticing any track marks on the witness; and on the basis of the evidence as presented, it can be concluded, reasonably, that Dr. Lieberman was not aware that this patient was in fact a drug abuser. During the first visit, she asked for Dilaudid and Valium and was given a prescription for both. Several months later, she again visited Dr. Lieberman for the purpose of securing drugs. On this visit, she complained of cramps, which again was not true, but at the conclusion of the visit was issued a prescription for Dilaudid. Approximately four years later, she again visited Respondent for the purpose of procuring drugs. At this time, she was mainlining and presumes that she had tracks which she feels may have been seen by the doctor. However, she asked for and received drugs based upon her represented "illness" and the Respondent's examination of her. Just about this time, she was arrested for drug abuse. At the time of her arrest, she had a prescription bottle for Dilaudid and one with Valium in it, both of which she had received from the Respondent. While she was out on bond, she again went to see the Respondent and asked for drugs. He refused, however, to give her any at this time because he had finally become aware that she was abusing drugs. She saw him several times thereafter and, on each occasion, he gave her only legitimate prescriptions; and she has not taken any illegal drug since 1980. The testimony of Dr. Lieberman on this same patient is consistent with that of the patient herself, though from a different perspective. The doctor's records reflect that the first visit from this patient on January 10, 1979, concerned her claim that she had had no period for three months and was in great pain. Examination revealed that her stomach was distended. He did a pelvic examination and found that her vagina was inflamed and she had a vaginal discharge. He gave her antibiotics for the infection and suggested that she have a laparoscopy examination in which a light device is passed through the navel into the fallopian tubes. The conditions described by the patient, if true, are in fact painful. The lack of period can be extremely painful because as a result the organs are swollen with fluid. The vaginal discharge and the history associated therewith indicated a possibility of pelvic disease and an inflammation of the fallopian tubes. It was for this reason that the laparoscopy was suggested. Because it was obvious that the patient was suffering great discomfort and because of her representation that Dilaudid was all that helped her (she was allergic to codeine and aspirin), he prescribed that drug for her. It is significant to note here that her allergy to codeine and aspirin limited the painkillers she could take and, as a result, which he could prescribe. He states that at the time of the examination, he saw no drug tracks on her body and did not know that she was an addict. He cautioned her on Dilaudid's addictive propensity and wanted her to have the laparoscopy so as to get her off Dilaudid as soon as possible. Dr. Lieberman was again visited by Ms. Creed in March 1979, approximately two months after the first visit. During this second visit, in which she stated she again had no period in the intervening two months since the first visit, the examination reflected that her stomach was tender, as were her organs, as well. The doctor gave her a hormone to start and regulate her periods and Dilaudid for the pain. On each prescription, Dr. Lieberman prescribed 20 capsules of Dilaudid. This drug is for severe pain, and he prescribed it only because, in his professional judgment, he felt she was in pain severe enough to justify it. Wilda Sue Boudreaux, another of Respondent's former patients, went to see him in May 1979, for the treatment of female problems. Dr. Lieberman recommended she have a hysterectomy, to which she agreed. She went into the hospital on May 23, 1979, for that operation and a bladder tac with removal of preexisting adhesions. Both operations were successful, and she was released after seven days' hospitalization. Dr. Lieberman saw her several times during her postoperative course of treatment. The surgery was done during the second or third day she was in the hospital. After the surgery, she was having severe pain and complications with a nerve in her leg that had been nicked during the hysterectomy surgery. After she was released from the hospital, because of these conditions, she was in constant, severe pain to the point she could not walk. Pain radiated through her leg and her lower body. She communicated these complaints to the doctor and received from him a prescription for Percodan. The Administrative Complaint alleges she received prescriptions on June 4, 5 and 19 and September 4 and 12. Ms. Boudreaux admits having received all prescriptions except the one on June 5 and denies emphatically that she received prescriptions for Percodan two days in a row. At the time the doctor prescribed Percodan for her, he told her it was a strong drug and should be taken carefully. She requested it, however, because it was the only drug that helped her. A couple of months after this surgery, she developed a urinary infection which resulted in severe pain during urination. She also continued to have severe pain in her left side where the leg nerve damage was and repeated pain from the prior surgery. She went back to the Respondent for a follow-up visit, and he hospitalized her for further tests. As a result of the tests, it was determined that the pain was due to severe nerve damage and that the pain would continue for some extended time until the nerve damage healed. Ms. Boudreaux considers Dr. Lieberman to be a good doctor who was concerned about her as a patient and who, at the time he gave her a prescription, explained to her why she was having the problems, what drugs he was giving her and what the drugs were for. It is her opinion that, throughout the entire period of time she was in contact with him, he appeared to be concerned about her as a person, not only as a patient. Respondent's testimony regarding his treatment of this patient was consistent with hers. He first saw her in March 1979, when she had a complaint regarding constant vaginal bleeding, painful periods and, as a result, he determined that she needed a complete hysterectomy, including complete removal of the tubes and ovaries, and surgery for preexisting bladder problems. During that operation, she sustained damage to a nerve which resulted in constant pain in her leg and abdomen. Nerve damage is one of the slowest types of damage to heal. As a result, this patient experienced constant pain over a long period after the surgery. On top of that, she developed a urinary tract infection as a result of the bladder surgery. As a result, she was maintained on Percodan until the infection cleared up and the nerve damage repaired itself. In the doctor's opinion, all the prescriptions for Percodan were appropriate. It is important to note here and with regard to the other allegations not the date of the prescriptions, but when and how they were to be used. Ms. Boudreaux is a school bus driver and a very responsible person; and Dr. Lieberman felt it was appropriate to prescribe Percodan as he did for her to stockpile them so that she would not have to come back into his office so often. In fact, she did not come back after June 19 until September 4, almost three months later. At that point, she still had the nerve damage and the bladder infection was first discovered. Petitioner made much of the fact that there may have been a less addictive drug that could have been used, both for this patient and for Linda Creed. Respondent claimed, however, that, based on his knowledge of the case of the individuals, he had no reason to disbelieve them; and in the case of Linda Creed, when she said Dilaudid had worked previously, he prescribed that in good faith. There is no evidence to show he did other than that in any case. Regarding the allegations pertaining to patient Patricia Rousseau, the patient information reflects that when first seen by Dr. Lieberman, Ms. Rousseau was a 30-year-old waitress with one child. She appeared well kept and was the sole support of herself and her child and needed to continue to work. At the first visit on July 9, 1979, Ms. Rousseau came in for an abortion, which was accomplished. At the time of her release, Dr. Lieberman prescribed 20 Percodan tablets to be taken one every six hours because, in this case, he thought it was medically indicated. Ms. Rousseau indicated she was in severe pain; and, based on the doctor's experience, he was convinced that, as a result of the procedure followed surgically, the pain could last for at least five days, which was the time it would take to use 20 tablets, taking one every six hours. Dr. Lieberman saw Ms. Rousseau again in January 1980. By this time, she had gotten pregnant again and wanted another abortion. She advised him that she had been to a clinic for that procedure and had developed an ovarian cyst. When Dr. Lieberman examined her, he felt that she could have a cyst, which, in his opinion, is a painful condition, and gave her medication for it. Here, he feels Percodan was indicated because of the fact that the condition arose from a second abortion and the additional pain that went along with it. Along with this condition, she also had dismenhorreah, a condition manifesting itself in painful periods, which, according to the Respondent, can be extremely painful and, in some women, totally disabling. Considering the fact that the patient needed to continue to work, as she was the sole support of herself and her child and could not be bedridden because of her period for three to five days each month, he felt Percodan was indicated, which he prescribed 15 or 20 at a time once a month for use during her period. The quantities prescribed were not, in his opinion, excessive. An additional patient who visited Respondent and whose course of treatment was considered to be improper by Petitioner was Martha Star Curtis, whose first visit to Respondent was on July 27, 1978. She was complaining of lower abdominal pain which, upon examination, turned out to result from a pregnancy. On August 2, 1978, this pregnancy was aborted. Her medical history, taken by Dr. Lieberman, revealed a prior ectopic pregnancy in the right tube and a lost tube and ovary. The following year, she had a cyst removed from her left ovary. At her first postoperative checkup, three weeks after surgery, Dr. Lieberman noticed a small ovarian cyst. When she came back a month later, the cyst was larger and was very painful. This pain related to the cyst was magnified because of chronic pelvic inflammatory disease, and Dr. Lieberman proposed to do a laparoscopy. Ms. Curtis had previously agreed that if this procedure had shown anything irregular, the doctor could go in, check it out and take care of whatever problem existed on the condition that her reproductive capability not be removed. As it turned out, upon accomplishment of the procedure, the doctor discovered that Ms. Curtis had substantial internal scar tissue in her pelvic area which had attached itself to her bladder, tubes, ovaries, intestines, interior of the "belly" and other internal and pelvic areas. This creates almost debilitating, constant pain as scar tissue develops, which increases as the scarring advances. Movement makes it worse--even the simple movements of walking, turning, etc. Even when the scar tissue is removed, it comes back unless there is a hysterectomy. Contra to this theory is the testimony of the Petitioner's expert, Dr. Lewis, who opined that movement not of the individual, but of the organ, would create pain. This difference in opinion is not particularly significant, however, as it is hard to conceive how movement by an individual, unless undertaken with an extremely delicate step, would not result in movement of the organs. In any case, since Dr. Lewis did not examine the patient, was not familiar with her nature, her makeup, or her disposition, it is more logical to assume that the physician who treated her over an extended period of time would be more acquainted with her condition and with the results of her activities than would one who sits in his office examining merely records. In this case, therefore, the observations and opinions of Respondent, who treated the patient, who performed the surgery and who was familiar with the individual, prevail. It is also pertinent to note here that Ms. Curtis, at the time this situation was going on, had met a man she intended to marry and bear children for. As a result, she did not agree to have the needed hysterectomy that was the only procedure that would cure the problem and remove the pain, at least until such time as she conceived and bore this man a child. Therefore, under those circumstances, in the opinion of the Respondent, Percodan was appropriate. Even though they are frequent and repeated, in his opinion, in light of her circumstances, her mental, physical, emotional and situational needs, this regimen was called for. While the Physician's Desk Reference indicates the standard dosage of Percodan as one every six hours, it also provides that this dosage can legitimately and should be exceeded when the situation calls for it. It is pertinent, also, to note here that Ms. Curtis at this time was traveling with her intended husband, a truck driver, in his truck, a situation which created more pain than would normally be experienced, and because of that could not come into the doctor's office as often as necessary. Therefore, in light of the fact that she would not agree to the only procedure that would alleviate her pain, the hysterectomy, and insisted on traveling with her putative husband, it was imperative that she receive relief from the pain, and Percodan was the only thing that would do it. Dr. Lieberman also treated a Julie Londy, first on August 18, 1980, when she came to see him, complaining of chronic pelvic pain, chronic bleeding from the vagina and painful periods. This lady was married, wanted no children and desired a hysterectomy. She entered the hospital for that procedure on April 22, 1980, and had a total abdominal hysterectomy plus an appendectomy on April 24, 1980. She was discharged on May 3, 1980. The conjunction of two major surgical procedures may have increased her pain, and her pain may have carried over from the previous condition she was experiencing, thereby reducing her tolerance for pain. Dr. Lieberman prescribed Tylox on three separate days within a six-day period, May 3, 7 and 9, 1980. Tylox is a Class II drug which is indicated for the reduction of pain. The generally accepted dosage is one every six hours, except in extreme discomfort, when the dosage can be increased. In this case, Ms. Londy was experiencing great pain because, coincident with her recuperation from the hysterectomy and appendectomy, she was experiencing a bladder infection; and, since she is allergic to codeine, Demerol, Dilaudid and aspirin and had told Respondent that Tylox was the only medication that would relieve her pain to which she was not allergic, he prescribed that substance. The first prescription was given on May 3, 1980, the day of her discharge from the hospital, and consisted of 40 pills. That should have lasted for ten days at the normal rate. The second prescription, for 30 pills, was given four days later because she was experiencing great discomfort. The third prescription, for 40 more, was administered on May 9, 1980, at her regular follow-up visit, after which the doctor was not to see her again for at least a month. It was his intention, by prescribing so many pills at one time, to give her a restful postoperative recovery; and the large number of pills was an advance. As a matter of fact, after May 9, the doctor did not see her again until late June 1980, some six weeks after the date of the last prescription. At that time, she was experiencing no pain, and neither asked for nor received additional narcotics. Respondent first saw Marilyn Quantrill on February 1, 1977. At that time, the patient, a 21-year-old female, was in early stages of pregnancy and wanted an abortion. This procedure was accomplished on February 7, 1977. Shortly thereafter, she got pregnant again and, despite the fact that she was being beaten by her husband, she decided to have the baby and did. Her husband continued to beat and emotionally abuse her (threats to take the child) to the point that she was a "nervous wreck." When she came to see Dr. Lieberman for the Seconal on July 17, 1978, her condition was such that she could not sleep because of her relationship with her husband, and Respondent gave her the Seconal to help her sleep. She was experiencing difficulty in coping with stress, and this condition is made worse by lack of sleep. She needed to sleep, and he gave her the pills in question to help her sleep. He thought his prescription for one pill per day at night for sleep was appropriate. The total number of Quaaludes prescribed over the five-month period was 210 pills. The period in question accounted for approximately 163 days. This is slightly over one pill per day, not notably excessive. It is also noted that Dr. Lieberman initially prescribed Seconal, thereafter switching to Quaaludes. He discontinued the Seconal because it was not strong enough to provide the necessary effect in light of her situation. It is also noted that Ms. Quantrill's husband was reported to be a drug dealer. When Dr. Lieberman found out this was the case, he not only stopped providing drugs for Ms. Quantrill, he declined to take her as a patient any longer. In the case of patient Stormy Druga (Smith) who received a drug called Eskatrol on three different occasions for weight loss, the allegation is not that the doctor prescribed improper amounts of the drug, but that the drug was prescribed for a purpose not permitted under Florida Statutes. Dr. Lieberman admits prescribing the drug on the date set out and the amount. He had used this drug for this patient before because she was overweight. She had just had a hysterectomy, was getting a divorce and desperately wanted to lose weight to improve her appearance. The prior use was successful in that she lost 30 pounds. Though Dr. Lieberman subscribed to numerous publications, he did not know that Florida had changed the law, prohibiting the use of Eskatrol for diet purposes. During the period in question, from August through November 1980, Ms. Druga came in every month for a weight control regimen, and he prescribed 30 pills each visit for a total of three visits. Unknown to him, the Florida Legislature had recently changed the law, prohibiting the use of any amphetamines or sympathomimetic amine drug or a compound designated as a Schedule II controlled substance, except for certain conditions of which weight control is not one. The first notice that Dr. Lieberman had that the law was changed was a bulletin issued by the Department of Professional Regulation in February 1981, three months after he stopped the prescription. In that regard, Dr. Lewis, the Petitioner's witness, stated that according to his experience, a doctor becomes aware of a change in one of several ways: (1) drug company flier, (2) a pharmacist's comment, and (3) national subscription-type letters. However, the State does not normally send out any bulletins regarding changes at the time the change is considered or initially made. Under these circumstances, it is quite likely that Respondent was not aware of the fact that the law had changed, prohibiting the use of Eskatrol for weight control purposes, during the time he prescribed it for Ms. Druga, as alleged. Each allegation against Respondent was evaluated by an expert in the field of obstetrics/gynecology for both Petitioner and Respondent. Petitioner's expert, Dr. Lewis, concluded, with regard to Ms. Rousseau, at least, that Respondent's charting is weak; he did not indicate on the record if the patient was seen on any of the visits which resulted in the issuance of a prescription and that Percodan, in this case, was prescribed without any clinical entry of observations on the records. On the other hand, Respondent's expert, Dr. Harry J. Stone, concluded that Percodan was appropriate in both the substance and the amount prescribed for Ms. Rousseau, a total of approximately 320 capsules over a two-plus-year period. If, as was claimed by Dr. Lewis, none of the prescriptions are charted, even that does not constitute malpractice because, according to Dr. Stone, in the practice of obstetrics end gynecology, quite often medications are not charted when the doctor is called out on an emergency situation before he can put it on the chart. As to Ms. Druga, Dr. Lewis indicated that Eskatrol was withdrawn from market use for weight control in 1980 because so much got into the Black Market and because of the undesirable side effects of amphetamines. The records examined by the doctor, which cover a period of time not alleged in the Administrative Complaint, show that over a period consisting of one year, five months and 21 days, Ms. Druga received 480 capsules and diuretics with a total weight loss of 10 pounds. While this is not successful weight loss maintenance, it is nonetheless not unusual depending upon the individual. Dr. Stone, himself, did not know of the change in the law regarding Eskatrol when it went into effect on July 1, 1980, and in his opinion, knowledge of this change within the medical community was poor. Both experts are in agreement that the State does not notify doctors of the changes, as the federal government does. The notices generally go to the pharmacists and, as a courtesy, the pharmacist should have called the Respondent, especially since the prescription here clearly stated it was for diet control. There is no question that prescriptions were issued for Eskatrol by Dr. Lieberman at a time when the law had been changed to prohibit the use of that drug for weight control purposes. It is equally clear, however, that Dr. Lieberman was unaware of the change and that insufficient effort was made by the State at the time to provide knowledge of the change to the various physicians. Turning to Ms. Quantrill, Dr. Lewis feels that because the patient came in and requested Valium and thereafter, as indicated in her letter to the Respondent, took 30 milligrams at one time, which is an excessive dose, Respondent should have suspected that she was likely to abuse drugs. She received prescriptions for 210 Quaalude capsules within a 163-day period. Dr. Stone, on the other hand, opined that the amounts in question were justified based on the emotional strain the patient was undergoing, as well as the pain from her condition. As to Ms. Creed, Dr. Lewis feels that when a patient asks for a particular Class II drug, that is characteristic of an addict, and he does not believe that Dilaudid was called for when Respondent administered it. On the other hand, Dr. Stone, based on the medical records he reviewed, including patient's case history, feels that under the circumstances of the first visit, the prescription of Dilaudid was appropriate in both substance and amount because of the acute pain associated with chronic pelvic disease. The antibiotics that were prescribed by Dr. Lieberman to cure this condition take a long time to work, and the patient needs help to stand the pain. If Dilaudid had worked in the past, it was not inappropriate to use it again. As to the second visit when Ms. Creed got Dilaudid, Dr. Stone feels that again the drug and the amounts prescribed were appropriate for much the same reasons. As to Ms. Boudreaux, Dr. Lewis feels that Respondent's records do not show any complications, and he feels that the drugs prescribed were too much in quantity for an uncomplicated postoperative course. It should be noted here, as elsewhere, that Dr. Lewis, in examining Dr. Lieberman's records, is at times very critical of them as being not complete enough, but at other times relies on them to support his viewpoint. For example, the witness uses the number of pills listed in the record to support the conclusion of over prescription without knowing the patient or having seen her, but when asked if the records say that Respondent stopped prescribing the drugs, this same witness states, "But we don't know what transpired because it's not in the record of what he saw the patient about, whether a medical problem or a drug problem." Dr. Stone, on the other hand, is of the opinion that the prescription of Percodan for Ms. Boudreaux was appropriate because of the combination of the two operations., the insertion of a painful catheter for a long period (six days) , the infection (which was painful) and the nerve injury (very painful). Because of the second hospitalization for the infection in September, Dr. Stone feels that the Percodan prescribed in September and October was appropriate. There does not appear to be an opinion from Dr. Lewis on the treatment given to Ms. Curtis. Dr. Stone, however, opines that the Percodan prescribed by Respondent for this patient from March to July 1979, was justified because of the repeated surgery. A second operation in the same area as former surgery is very painful. This drug can be given and was given at a prescribed rate of one every four hours as necessary for pain. In the opinion of Dr. Stone, this is reasonable, even though the Physician's Desk Reference calls for administration of one every six hours. In addition, continued use, which admittedly this patient had done, develops a tolerance which can result in raised usage. Therefore, even though Dr. Lieberman prescribed 830 pills over 121 days, a rate of almost seven a day, while higher than normal, this is not so aberrant a prescription rate under these circumstances as to be considered necessarily inappropriate or constitute substandard practice. Dr. Lewis also did not give an opinion as to Ms. Londy, for whom Tylox was prescribed. Dr. Stone, on the other hand, felt that the use of Tylox in the amounts prescribed was justified. Here, the patient had undergone major surgery, including an appendectomy, had had implanted a drain and had developed a fever, which indicates infection, with swelling and pain. All of these conditions justify the use of the drug in the amounts. Though the total quantity may seem high, it should be noted, however, this was only for a short period, and the pain of all the surgery and the patient's condition under these circumstances rendered this prescription in this amount not necessarily inappropriate. Based on his overall evaluation of the various patient records and his knowledge of Dr. Lieberman gained from observing him on staff at Florida Hospital and Respondent's excellent reputation as a gynecological and obstetrical surgeon in his community, he is satisfied there has been no gross or repeated malpractice in what Dr. Lieberman has done. Further, his review of the records reveals no indication of fraud, trickery, or any of the other alleged deceptive representations or any indication of bad faith on the part of the Respondent. Petitioner offered no evidence of these latter characteristics. Turning to the issue of medical stockpiling, however, Dr. Stone is quick to admit and recognize that the stockpiling of medicines as was done here in some cases by this Respondent is not a good idea. However, in the world as it exists, it may in some cases, and he is of the opinion that it was in the cases here, be acceptable practice, and not malpractice. Respondent, who has treated approximately 10,000 patients since he entered medical practice in 1976, routinely prescribes controlled substances in his practice. When he does so, he uses a high degree of care because of the addictive nature of Class II drugs. Before prescribing, he considers the individual and their medical problem needs. Modern OB/GYN practice allows physicians in these specialties to serve as "full" physicians to women, and they can treat their patients for illnesses other than those related to the OB/GYN practice. Under this situation, the doctor is required to also consider the emotional, physical, psychological and socioeconomic needs of his patients. It is wrong to merely consider records. A doctor treats people.
Recommendation On the basis of the above, it is, therefore, RECOMMENDED: That the Administrative Complaint against Respondent, Robert A. Lieberman, M.D., be dismissed and no disciplinary action be taken against him on the basis of the activity alleged in this Administrative Complaint. RECOMMENDED this 31st day of January 1984, in Tallahassee, Florida. ARNOLD H . POLLOCK 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 31st day of January 1984. COPIES FURNISHED: Barbara K. Hobbs, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Herbert M. Hill, Esquire Thomas Michael Burke, Esquire Post Office Box 1873 Orlando, Florida 32802 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Ms. Dorothy Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
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 The Respondent, Stephen L. Watson, M.D., has been practicing medicine in Lakeland, Florida, since 1945. Since 1950, he has been board-certified in obstetrics and gynecology. Until this case, he has not been the subject of any Board of Medicine disciplinary proceeding. He recently closed his practice of medicine due to his own poor health. The Respondent saw B. D., as a gynecology patient, for the first time in December, 1983. She was 33 years old at the time and was obese, weighing 184 pounds and standing only approximately five feet, four inches. She also had borderline high blood pressure, at 140/90. On the patient's second visit in July, 1984, the Respondent discussed her weight and gave her a book on diet and weight loss entitled, "The Lighter Side of Life, the Doctor's Program that Really Works." He discussed the contents of the book with her, emphasizing certain parts of it. He also prescribed a month's supply of an appetite suppressant called Fastin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient's next visit was a weight conference on January 2, 1987. On this visit the patient weighed 212; her blood pressure was 140/90. The Respondent again discussed weight and diet with the patient and prescribed a month's supply of another appetite suppressant called Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic. Didrex contains the anorectic agent benzphetamine hydrochloride. It is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include some central nervous system stimulation and elevation of blood pressure. Didrex is contraindicated in patients with moderate to severe hypertension, and caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. At the visit on January 2, 1987, it also was arranged that the Respondent would have blood work done on January 6, a pelvic examination on January 7, and another weight conference on January 29, 1987. As often would happen during the long doctor-patient relationship, the patient missed all three appointments and did not request a refill of her medications. The patient's next visit was for another weight conference on February 10, 1987. She had lost 12 pounds (down to 200), and her blood pressure reading was down to 130/88. The Respondent's course of treatment seemed to be effective. The Respondent prescribed another month's supply of Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic. Ten days later, the patient came in complaining of "nerves" after taking her medications. The Respondent discontinued the Didrex and the diuretic and scheduled the patient for another weight conference for March 10, 1987. The patient missed the March 10, 1987, appointment as well as the next two rescheduled appointments, and she did not request a refill of her medications. Finally, the patient kept the third rescheduled appointment for a weight conference, for May 6, 1987. By this time, the patient's weight was back up to 208. Her blood pressure reading was 120/80. The Respondent prescribed a month's supply of another appetite suppressant called Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her weight conference scheduled for June 3, 1987, and did not request a refill of her medications. The patient kept her rescheduled appointment for a weight conference, for June 11, 1987. This time, her weight was back down, to 197, and her blood pressure reading was 120/80. The Respondent's course of treatment seemed to be effective. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient again missed her next scheduled weight conference, for July 9, 1987, and did not request a refill of her medications. The patient kept her rescheduled appointment for a weight conference, for July 13, 1987. This time, her weight was down further, to 187, and her blood pressure reading again was 120/80. The Respondent's course of treatment continued to seem to be effective. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient's next weight conference was on August 17, 1987. Her weight was down a little more, to 183.5, and her blood pressure reading remained at 120/80. The Respondent's course of treatment continued to seem to be effective, although the patient's rate of weight loss was decreasing. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, but discontinued the diuretic apparently due to a bladder problem. The patient missed her next scheduled weight conference, for September 15, 1987, and did not request a refill of her medications. The patient's next rescheduled weight conference was on October 9, 1987. Her weight was up a little, to 184.75. Her blood pressure reading again was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next scheduled weight conference, for November 6, 1987, and did not request a refill of her medications. The patient's next rescheduled weight conference was on December 7, 1987. Her weight was down a little, to 183. Her blood pressure reading again was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next scheduled weight conference, for January 5, 1988, and did not request a refill of her medications. The patient's next rescheduled weight conference was on February 18, 1988. Her weight was up a little, to 187.5. Her blood pressure reading was 130/80. The Respondent prescribed a month's supply of another appetite suppressant called Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. Tenuate Dospan contains the anorectic agent diethylpropion hydrochloride. Like Didrex, it is a sympathomimetic amine with some pharmacologic activity similar to that of the prototype drugs of this class used in obesity, the amphetamines. Actions include some central nervous system stimulation and elevation of blood pressure. It is contraindicated in patients with severe hypertension, and caution is to be exercised in prescribing it for any patient with hypertension. The Respondent did not see the patient again for weight control, or prescribe any more medication, until May 3, 1988, when the patient was seen for bladder problems. Her weight was down a little, to 181.5, and her blood pressure reading was 120/80. The Respondent prescribed another month's supply of Ionamin, to be taken in conjunction with the diet recommendations, but discontinued the diuretic again apparently due to a bladder problem. The patient preferred Tenuate Dospan, and the Respondent changed the prescription to another month's supply of Tenuate Dospan. The patient missed the next two conferences, scheduled for August 8 and rescheduled for August 9, 1988, and did not request a refill of her medications. She did not see the Respondent or get any more medications from him until a weight conference on December 2, 1988. Her weight was up a little, to 185. Her blood pressure reading was 130/80. The Respondent prescribed a month's supply of Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient missed her next four scheduled appointments and did not request a refill of her medications. She did not see the Respondent or get any more medications from him until a blood pressure conference on June 28, 1989. Her weight was up significantly, to 200, and her blood pressure reading was up significantly, to 140/100. Although the patient still was relatively young (approximatly 39), and the Respondent believed there was a causal connection between the patient's weight and blood pressure, the Respondent prescribed only a month's supply of Enduron, a medication for hypertension. The patient missed her next two scheduled blood pressure conferences and did not request a refill of her blood pressure medications, or request any other medications. She did not see the Respondent or get any more medications from him until she saw him for blood in the urine on October 3, 1989, and had a urinalysis and conference. At the time, her weight was up a little more, to 203, and her blood pressure reading was 140/90. The Respondent prescribed an antibiotic and, for reasons not apparent from the evidence, a month's supply of a mild antidepressant, called Elavil. On or about October 23, 1989, the patient telephoned for a refill of her Enduron prescription, which was about to run out, and the Respondent prescribed another month's supply. The patient again missed her next weight conference scheduled for October 30, 1989, and did not request any other medications. She did not see the Respondent or get any more medications from him until a rescheduled weight conference on December 11, 1989. By this time her weight was up to 217, and her blood pressure reading was 140/98. The Respondent was aware that amphetamine-like appetite suppressants should be used with caution with patients having moderately high blood pressure, as the patient had by December 11, 1989. But he also continued to believe that there was a causal connection between the patient's weight and blood pressure and that, given the patient's relative youth and the past success with the treatment, it was worth trying appetite suppressants, in conjunction with diet recommendations, to help reduce both the patient's weight and her blood pressure. He prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. (Tenuate is essentially the same drug as Tenuate Dospan but is shorter lasting.) On January 5, 1990, the patient telephoned the Respondent with a complaint of "nerves." The Respondent prescribed another month's supply of Elavil, with authority for two refills. The patient's next weight conference was on January 24, 1990. Her weight was up a little more, to 220, and her blood pressure reading was 160/98. At that point, it seemed that perhaps the Tenuate Dospan was not effective. Although there could be other explanations why the patient was not losing weight, and it was possible that all appetite suppressants had become ineffective, the Respondent decided to switch the patient to Didrex, which seemed to have been effective in the past, and prescribed a month's supply, to be taken in conjunction with the diet recommendations, along with a diuretic. He also changed her blood pressure medication to Wytensin. The patient missed her next weight conference, scheduled for January 31, 1990, and did not request any additional medications. The patient did not see the Respondent again, or get any additional medications from him, until March 21, 1990, when she saw him to get a letter for employment purposes certifying that she was disease-free. Her weight was up to 226, and her blood pressure was 164/96. The Respondent prescribed another month's supply of Didrex, to be taken in conjunction with the diet recommendations, along with a diuretic and another month's supply of Wytensin. The patient did not see the Respondent again, or get any additional medications from him until August 28, 1991, when she saw him to complain of blood in the urine. At this time, her weight was 234, and her blood pressure reading was 140/90. In addition to treating the urine problem, the Respondent prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic and a month's supply of Wytensin. The patient missed her appointment for a pelvic examination on September 5, 1991, and did not see the Respondent, or get any additional medications from him until she went to a weight conference on December 11, 1989. Her weight was 234.5, and her blood pressure reading was 140/94. The Respondent prescribed a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. (It is not clear from the evidence why no blood pressure medication was prescribed.) The patient missed her appointment for a pelvic exam on December 17, 1991, and missed scheduled weight conferences for February 10, 11, and 19, 1992. She did not request any additional medications during this time. The patient made her next scheduled appointment on March 16, 1992, when the Respondent discussed her weight, blood pressure and complaint of headaches. Both her weight and her blood pressure were at their highest: weight, 237; blood pressure reading, 150/110. At this point, there was a real question whether the appetite suppressants still were effective in controlling the patient's weight and thereby helping reduce the patient's blood pressure. On the other hand, the patient continued to miss weight conferences and not follow through on the Respondent's instructions, and it was not clear whether the patient ever had followed the Respondent's weight control treatment long enough to give it a fair chance to work. The patient's blood pressure now was moderately to severely high; on the other hand, she still was only about 42 years of age, and her weight still could have been contributing to her high blood pressure. Nonetheless, the Respondent decided to prescribe only Wytensin on March 16; he also scheduled a complete physical for March 20, 1992. On March 20, 1992, the Respondent had the patient undergo a complete physical. Her weight still was 237, and her blood pressure reading was 160/120. He switched her blood pressure medication to Accupril and decided not to prescribe any appetite suppressants at that time. He scheduled the patient for a weight conference on April 3, 1992. On April 3, 1992, the patient's weight still was 237, but her blood pressure reading was 150/110. Although the patient's blood pressure still was moderately to severely high, the Respondent decided to try an appetite suppressant to reduce her weight in the hopes of, together with the blood pressure medication, effecting a lasting reduction in her blood pressure. He prescribed a month's supply of Tenuate Dospan, to be taken in conjunction with the diet recommendations, along with a diuretic. On April 14, 1992, the patient telephoned the Respondent to report that her blood pressure still was up and that she continued to suffer from headaches. The Respondent decided that it was time to refer the patient to a specialist in internal medicine and made an appointment for her. The patient missed her next scheduled weight conference on April 16, 1992, and missed the appointment with the internist which the Respondent had scheduled for her. She never saw the internist. The patient's next appointment was on May 6, 1992. The Respondent discussed the patient's weight and her hypertension. Her weight was 236, and her blood pressure reading was down to 144/100. The Respondent decided to prescribe a month's supply of Tenuate, to be taken in conjunction with the diet recommendations, along with a diuretic. The patient overdosed on a pain medication (not the appetite suppressant) and was hospitalized on June 4, 1992. She missed the next scheduled weight conference on June 15, 1992. She did not request any additional medications. The patient's next appointment with the Respondent was on June 18, 1992. She weighed 230, and her blood pressure reading was 140/110. The Respondent prescribed only Accupril and an iron supplement. The Respondent only saw the patient once more, on July 17, 1992, for gynecological problems, and referred the patient to a specialist. He did not prescribe any medications. The patient's blood pressure was 130/100. Her weight was not recorded. The evidence does not reflect that the patient, B. D., grew progressively dependent on the appetite suppressants the Respondent prescribed for her. There was no evidence that the patient ever asked for a refill or new prescription early. She often missed scheduled appointments, resulting in gaps of time between prescriptions when the patient presumably had no appetite suppressants available to her. There also were extended periods of time between visits during which time the patient presumably had no appetite suppressants available to her. Some reputable physicians now seriously question the use of appetite suppressants. There is some evidence that patients lose as much weight and maintain as much weight loss without them as with them. The trend in the late 1980s and early 1990s has been to treat patients for obesity with behavior modification (essentially, diet and exercise) only. But there is no evidence that it is below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances to treat patients for obesity by prescribing appetite suppressants in conjunction with diet recommendations. It is true that the Respondent prescribed appetite suppressants for longer periods of time than recommended in the medical and pharmaceutical literature. The literature recommends using appetite suppressants only during the early weeks of a weight reduction program. The reasons are twofold and related: first, the patient generally builds a tolerance to the appetite suppressant, making them less effective; second, the patient can become dependent on them. The goal is to use appetite suppressants to begin reducing caloric intake for initial weight loss, while changing eating habits for long term reduction in caloric intake and weight. The problem confronting the Respondent in this case lay in the nature of the patient's noncompliance. She would begin the program but not follow it or continue with it for long. When she returned to the Respondent after a long hiatus, it was like starting the program over again. The evidence did not prove that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent to repeatedly restart his treatment for obesity, namely by prescribing appetite suppressants in conjunction with diet recommendations. There were occasions when the Respondent prescribed an appetite suppressant when the patient's blood pressure reading was high. According to the medical and pharmaceutical literature and the expert medical testimony, caution should be exercised in prescribing these medications for patients with high blood pressure. But the exercise of that caution is a matter of medical judgment, based on an overall knowledge and understanding of the patient and circumstances involved. Only once, on April 3, 1992, did the Respondent prescribe an appetite suppressant (Tenuate Dospan) when the patient's blood pressure reading was so high (150/110) as to clearly contraindicate the use of the appetite suppressant. On all other occasions, the patient's blood pressure would be considered mildly or moderately high, requiring the Respondent to exercise caution, which he did. In all cases, the Respondent believed that there was a causal connection between the patient's weight and blood pressure and that, given the patient's relative youth and the past success with the treatment, it was worth trying appetite suppressants, in conjunction with diet recommendations, to help reduce both the patient's weight and her blood pressure. Although some physicians would disagree with the Respondent's medical judgments, except for April 3, 1992, it was not proven that the Respondent's medical judgment in this case fell below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. However, it is found that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent to prescribe Tenuate Dospan on April 3, 1992. It was not proven that it was below the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances for the Respondent not to refer the patient to a specialist for hypertension before April 14, 1992. The first evidence of severe hypertension appeared on her visit on March 16, 1992. But the Respondent had not seen the patient since December, 1991, due to missed appointments, and it was reasonable at that point for the Respondent not to refer immediately. It could be argued that he should have referred the patient after one of the next two visits, but the delay until April 14, 1992, was fairly short. It was not the Respondent's fault that the patient did not keep the appointment with the specialist which he made for her. It should be noted that the patient does not complain about the level of care and treatment given by the Respondent. Nor is there any evidence that the Respondent's care and treatment harmed the patient. Apparently, while the patient was hospitalized for overdosing on pain medication unrelated to the Respondent's care and treatment, the patient's medical records were brought to the attention of the predecessor of the AHCA, and it appeared to that agency (and to the AHCA) that the Respondent was guilty of worse practice of medicine than ultimately was proven in this case.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order: (1) finding the Respondent guilty of a single violation, on April 3, 1992, of Section 458.331(1)(t), which also resulted in a technical violation of Section 458.331(1)(q), Fla. Stat. (1993); (2) requiring the Respondent to notify the Board or the AHCA if he reopens his practice of medicine; (3) placing the Respondent on probation on appropriate terms in the event the Respondent reopens his practice; and (4) fining the Respondent $500. RECOMMENDED this 15th day of November, 1994, in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of November, 1994. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-2375 To comply with the requirements of Section 120.59(2), Fla. Stat. (1993), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. 1.-8. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven. Rejected as not proven. (The Respondent testified.) Accepted but subordinate and unnecessary. Accepted. First sentence, subordinate to facts contrary to those found; second sentence, subordinate to facts found. Rejected as not proven that the patient's hypertension was severe. Otherwise, accepted but subordinate to facts contrary to those found. 14.-19. Accepted and incorporated. Rejected as not proven, except for patients with severe hypertension. First sentence, rejected as not proven. (He believed it permissible because the patient's blood pressure was not stable.) Second sentence, accepted but subordinate to facts contrary to those found. Third sentence, accepted but subordinate to facts contrary to those found, and unnecessary. First sentence, accepted but subordinate to facts contrary to those found. Second sentence, rejected as not proven. Accepted. Subordinate to facts found. Accepted but subordinate to facts contrary to those found. First sentence, accepted but subordinate to facts contrary to those found. Second sentence, rejected as not proven as to Didrex after 1990; otherwise, accepted and incorporated. First sentence, accepted and incorporated. Second sentence, accepted but subordinate to facts contrary to those found, and unnecessary. (The AHCA did not charge inadequate records.) 27.-29. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as not proven. Accepted but subordinate to facts contrary to those found. Accepted and incorporated to the extent not subordinate or unnecessary. (The question is not whether a referral would have been appropriate but rather whether not referring was inappropriate.) Accepted and incorporated. Rejected as not proven that referral was required in 1984 or that the patient's weight and blood pressure did not respond to treatment before 1988. Otherwise, accepted and incorporated to the extent not subordinate or unnecessary. (The question is not whether a referral would have been appropriate but rather whether not referring was inappropriate.) Accepted but subordinate and unnecessary. Rejected. They knew it to the extent that it is the same as for an internist. 37.-38. Accepted but subordinate and unnecessary. 39. Rejected as not proven and as contrary to the facts found. Respondent's Proposed Findings of Fact. 1.-4. Accepted and incorporated to the extent not subordinate or unnecessary. 5. Accepted but subordinate and unnecessary. 6.-20. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to the greater weight of the evidence. Accepted but subordinate and unnecessary. 23.-28. Accepted and incorporated to the extent not subordinate or unnecessary. Other than evidence that she may have become nervous on occasion from the appetite suppressants, accepted and incorporated to the extent not subordinate or unnecessary. Accepted. The second occasion is irrelevant, having occurred after the events in issue in this case. The first is accepted and incorporated to the extent not subordinate or unnecessary. 31.-32. Accepted and incorporated to the extent not subordinate or unnecessary. Rejected as contrary to the greater weight of the evidence. Accepted and incorporated. Accepted but subordinate and unnecessary. 36.-37. Accepted and incorporated. 38.-40. Accepted. Subordinate to facts found. First sentence, accepted and incorporated. Second sentence, accepted but subordinate and unnecessary. Accepted (that it is not necessarily inappropriate) and incorporated. Accepted. First two sentences, incorporated; second, subordinate to facts found. Accepted. Subordinate to facts found. Rejected as to April 3, 1992, as contrary to facts found and to the greater weight of the evidence. Otherwise, accepted but subordinate to facts found. 46.-47. Accepted and incorporated. 48. Rejected as to April 3, 1992, as contrary to facts found and to the greater weight of the evidence. Otherwise, accepted and incorporated. COPIES FURNISHED: Alex D. Barker, Esquire Elaine Lucas, Esquire Agency for Health Care Administration 7960 Arlington Expressway Suite 230 Jacksonville, Florida 32211-7466 John A. Naser, Esquire 1401 South Florida Avenue Suite 201 Lakeland, Florida 33802 Dr. Marm Harris Executive Director, Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Harold D. Lewis, Esquire Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
Findings Of Fact Respondent's Exception A.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception A.2. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception B. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception C. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception D. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception E. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.2. is GRANTED. There is no competent substantial evidence in the record to support the finding, "It has nothing to do with thinness or girth of the Chinese people." Since the burden of proof is on the Petitioner, a lack of evidence by the Respondent on a point cannot be, itself, the basis for a finding of fact against Respondent. Respondent's Exception F.3. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.4. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception F.5. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.2. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.3. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception G.4. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exceptions H.1. through H.3. are REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.2. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.3. (first) is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception I.3. (second) through I.5. are REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception J.1. is REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception J.2. through J.3. are REJECTED for the reasons stated in the arguments of the Petitioner. Respondent's Exception J.4. is REJECTED for the reasons stated in the arguments of the Petitioner. RULINGS ON EXCEPTIONS TO CONCLUSIONS OF LAW Respondent's Exception A.1. is REJECTED on the basis that the Hearing Officer's analysis is correct. The Board is authorized and required to rule on federal laws and rules, as well as Florida Statutes, such as Chapter 499, which set forth the requirements that licensed medical doctors must meet but which are not within the Medical Practice Act, Chapter 458, Florida Statutes. This Exception is also REJECTED based on the reasons set forth in the Petitioner's argument. Respondent's Exception A.2. is REJECTED based on the written argument of the Petitioner. Respondent's Exception A.3. is REJECTED based on the Department's oral argument and its written arguments to Exceptions A.1. and A.3. to the conclusions of law. Respondent's Exception B.1. is REJECTED based on the arguments set forth by Petitioner. Respondent's Exception C.1. is REJECTED for the reasons stated in the oral argument by the Petitioner and the written argument by the Petitioner in response to Exceptions in C.1 in Exceptions to Findings of Fact and C.1. in Exceptions to Conclusions of Law. Respondent's Exception D. is REJECTED for the reasons set forth by the Petitioner. Respondent's Exception E. is REJECTED for the reasons set forth by the Petitioner. Respondent's Exception F.1. is REJECTED for the reasons set forth by the Petitioner. Petitioner's reliance on the Rodgers case is misplaced because that case involved full informed consent of the patients and did not involve fraud. Respondent's Exception F.2. through F.3. are REJECTED based on the reasons set forth by the Petitioner. Respondent's Exception G.1. is REJECTED for the reasons set forth by the Petitioner. Respondent's Exception set forth as "IV. SUMMARY" is REJECTED as cummulative. See Rule 21M-18.004, Florida Administrative Code. RESPONDENT'S EXCEPTION TO PENALTY 1. Respondent's Exception to penalty is REJECTED. PENALTY Upon a complete review of the record in this case, the Board determines that the penalty recommended by the Hearing Officer be ACCEPTED and ADOPTED. WHEREFORE, IT IS HEREBY ORDERED AND ADJUDGED that Respondent shall pay an administrative fine in the amount of $50,000.00 to the Executive Director within thirty days. Respondent's license to practice medicine in the State of Florida is SUSPENDED for a period of one year. Upon reinstatement from suspension, Respondent's license to practice medicine in the State of Florida is placed on PROBATION for a period of two years, subject to the special condition that Respondent pay $60,000.00 to the Department of Legal Affairs Division of General Legal Services, for use in consumer protection. This Order takes effect upon filing with the Clerk of the Department of Professional Regulation. DONE AND ORDERED this 17th day of August, 1989. BOARD OF MEDICINE FUAD S. ASHKAR, M.D. CHAIRMAN
Recommendation It is recommended that Dr. Willner be found guilty of ten counts of violation of the Medical Practice Act, that he be fined $50,000, and that his license be suspended for a period of one year, and that his licensure then be placed on probation for two years subject to the special condition that he pay $60,000 to the Department of Legal Affairs, Division of General Legal Services, for use in consumer protection. DONE and ORDERED this 7th day of June, 1989, in Tallahassee, Florida. WILLIAM R. DORSEY, JR. Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 7th day of June, 1989.
Findings Of Fact Respondent is a medical doctor, licensed to practice in Florida, and holds license number ME 0009310, issued by Petitioner. Respondent specializes in family practice and has been board certified by the American Academy of Family Physicians since 1974. Percodan is the manufacturer's brand name for oxycodone, which is a Schedule II controlled substance pursuant to Chapter 893, F.S. 2/ It is a drug used for the relief of pain, a synthetic analgesic, and is both a physically and psychologically dependent producing drug. It can cause drowsiness, urinary retention, nausea, vomiting, and interacts unfavorably with other sedative drugs, and is considered a depressant. On December 30, 1966, Evelyn Milstead, a 30 year old woman, came to Respondent's office complaining of nausea and a rash in her mouth. Respondent conducted a physical examination, took her medical history and thereafter prescribed tigan for the nausea. Ms. Milstead became a regular patient of Respondent's and he continued treating her for various ailments over a period of years. During the course of Respondent's treatment, Milstead developed a chronic urinary tract infection and kidney condition in which she passed kidney stones. On occasion Milstead was treated by Dr. Gillespie, a specialist in the field of urology for her kidney condition. In 1978, Respondent also referred instead to the Ochsner Clinic for evaluation of her urinary tract and kidney problems. She was evaluated at Ochsner Clinic and received prescriptions for darvocet, a pain medication, and keflex, an antibiotic, and was told that she would continue to have a chronic kidney problem. Over the years, Milstead was hospitalized several times by Dr. Gillespie for treatment of her kidney condition. The testimony of Dr. William H. Nass and Dr. Robert P. Johnson established that Respondent's initial prescriptions of percodan to Milstead were appropriate. However, Respondent's percodan prescriptions to Milstead eventually became inappropriate. Specifically, the prescriptions for 2,668 percodan tablets between August, 1980 and November, 1982, were established as excessive. On July 30, 1977, Bruce White, a 25 year old male, came to Respondent for medical treatment for headaches and thereafter returned to Respondent for treatment of various medical problems. Mr. White's wife, Vicki White, and their children were also seen by Respondent as their family doctor. On May 18, 1981, White came to Respondent complaining of neck and back pain from an automobile accident in which he also fractured his left lower leg. Respondent noted that White had been seen by a neurologist and an orthopedic surgeon for his head and leg. In addition to other medication, Respondent prescribed percodan to White for pain. White had also developed arthritis in his left leg, as a result of the car accident and fracture, and on one occasion was hospitalized for swelling of his left leg. Respondent referred White to Dr. Tippett, a neurosurgeon, concerning his headaches and to Dr. Graybiel, a rheumatologist, concerning his arthritis. However, White continued to see Respondent as his medical doctor because his work schedule on an offshore oil rig would only permit Saturday appointments with his doctor and Respondent's offices are open on Saturday mornings. White also found it difficult to pay the fees charged by specialists. Between May 8, 1981 and September 30, 1982, Respondent prescribed 780 percodan tablets for Bruce White. The testimony of Dr. Nass and Dr. Johnson established that Respondent's initial prescriptions of percodan to White were appropriate. However, the percodan prescriptions to White became inappropriate over time due to their excessiveness. The seriousness of this lapse is underscored by Respondent's failure to try other pain alleviating measures and failure to investigate abuse possibilities. On October 18, 1979, Vicki White, the wife of Bruce White, a 23 year old woman, came to Respondent's office seeking treatment. She complained of migraine headaches and stated that her father was in the hospital with cancer. She also stated that she had seen Dr. Eyser, a neurosurgeon, for her headaches. Respondent prescribed wygesic for her pain. She subsequently returned to Respondent for treatment of various complaints including chronic migraine headaches, colds, and a dislocated right shoulder. Initially, Respondent prescribed norcet for relief of this pain, and on July 31, 1981, first prescribed percodan for her migraine headaches. Respondent prescribed percodan on other occasions in response to her complaints of pain from migraine headaches and back strain. Respondent considered referring her to a neurologist for the headaches but White stated that she could not afford to see a specialist. Respondent prescribed 590 percodan tablets for Vicki White between July 31, 1981 and September 22, 1982. Percodan is an appropriate and acceptable medicine for the relief of migraine headaches, and Respondent's initial prescription of percodan to Ms. White was appropriate. However, his prescriptions became excessive over time since percodan is not to be used for long term treatment of migraine headaches. On September 7, 1982, M. D. Medlen, an Escambia County Deputy Sheriff, went to Respondent's office as an undercover police officer, under the assumed name of Donna Slay. She had been asked by Robert Powers, a narcotics officer with the Escambia County Sheriff's Department and Charles Deckard, an investigator with the Department of Professional Regulation, to go to Respondent's office in an undercover capacity and attempt to obtain a prescription for percodan. Medlen/Slay first gave general information to the receptionist, including identification, in the name of Donna Slay, chief complaint of a backache, previous illnesses, drug allergies, address, social security number, and insurance information. Medlen/Slay was shown to an examination room where her blood pressure and weight were taken by the nurse and a urinalysis was performed. Respondent then came in and asked Medlen/Slay what her problem was. She informed him that she had been pushed into a wall during a fight, and had injured her back. Respondent checked her pulse, did a range of motion test, and checked the alleged injured area by palpation. Each time Respondent pressed on the alleged injured area, Medlen/Slay told him it hurt. Respondent did not visually inspect the alleged injured area but asked Medlan/Slay if there was a bruise and she said no. In order to get the percodan, Medlen/Slay told Respondent that she had injured her back one other time and a doctor in Louisiana had prescribed percodan for that injury. Respondent asked how long ago Medlen/Slay had taken the percodan and she said one year ago. Respondent discussed the dangers of drug addiction with Medlan/Slay and then prescribed 20 tablets of percodan for pain and 30 tablets of indocin to reduce inflammation. Upon leaving Respondent's office, Medlen/Slay did not fill the prescriptions but turned them over to Deckard. Percodan is an acceptable medicine for back and shoulder pain. However, Respondent should have considered the possibility of fracture, visually examined the area to ascertain the presence of a hematoma (blood clot) and listened to the patient's chest to determine the presence of lung injury. Respondent did not perform an appropriate examination prior to prescribing percodan, and the prescription was therefore inappropriate. Respondent used poor judgment in his excessive prescriptions of percodan to the patients discussed herein. However, there is no evidence that Respondent prescribed the percodan for personal financial gain or that any patient was injured by Respondent's prescribing practices. The testimony of the expert witness established that the records maintained on these patients were inadequate. Frequently, the only notation for a given visit was the prescription for percodan, with no evaluation of the patient's condition. Further, Respondent's patient records did not even list all the percodan prescriptions issued. Thus, these records essentially reflect partial inventories of prescriptions issued, and do not justify the course of prescribing, which is important to the safe practice of medicine.
Recommendation Based on the foregoing, it is RECOMMENDED that Petitioner enter a final order placing Respondent on probation for a period of five years, require that Respondent practice under the supervision of another physician to be named by Petitioner during the initial year of his probation and that Petitioner restrict Respondent's license against prescribing Schedule II controlled substances while he is under such supervision. 4/ DONE and ENTERED this 24th day of April, 1984 in Tallahassee, Florida. R. T. CARPENTER, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of April, 1984.
The Issue This case concerns an administrative complaint brought by the Petitioner against the Respondent alleging various violations of Chapter 458, Florida Statutes. Generally speaking, the Respondent is accused of prescribing controlled substances in bad faith, deception, untrue and fraudulent representations in the practice of medicine failing to keep written medical records justifying treatment gross or repeated malpractice or the failure to practice medicine with the requisite level of care, skill and treatment expected of him and with the violation of a related provision of law, premised upon the aforementioned substantive violations.
Findings Of Fact The Board accepts and adopts and incorporates herein the Findings of Fact of the Hearing Officer. There is competent substantial evidence to support the Findings of Fact.
Findings Of Fact Petitioner is a pharmacist doing business as Dyal's Pharmacy in Daytona Beach, Florida. Petitioner is a Medicaid provider under the rules of the Respondent, operating under Provider No. 1018147. Respondent is a department of the State of Florida, with its principal office in Tallahassee, Leon County, Florida. Respondent is designated as the state agency responsible for the administration of Medicaid funds, and is authorized to provide payments for medical services, pursuant to Section 409.266, Florida Statutes. Pursuant to his responsibilities as a Medicaid provider and a pharmacist, Petitioner has, during the period of March, 1982, through August, 1983, filled 43 prescriptions for nonsteroidal anti-arthritic drugs other than buffered aspirin, which did not have the words "medically necessary" written on the prescription form by the prescribing physician in his own handwriting. Petitioner filed claims with Respondent with regard to the aforementioned prescriptions, and Respondent paid $854.44 to Petitioner as reimbursement. By letter received by Petitioner on December 27, 1983, Respondent has notified Petitioner of its intention to seek repayment of that amount pursuant to Rule 10C- 7.42(4)(b), Florida Administrative Cede. Rule 10C-7.42, Florida Administrative Code, provides, in pertinent part, as follows: (4) Covered Benefits * * * (b) All prescriptions for buffered or enteric coated aspirin must indicate that an arthritic condition is being treated and dispensed in quantities no less than 200. Any nonsteroidal anti-arthritic drug, other than buffered aspirin, must have `medically necessary' written on the prescription by the practioner in his own handwriting. Noncompliance will warrant recoupment. Petitioner has sought an informal hearing regarding Respondent's attempt to recoup amounts previously paid to Petitioner, but in light of the provisions of the challenged rule it is unlikely that he can prevail. The existence of Rule 10C- 7.42(4)(b) is the only basis upon which repayment could be demanded by Respondent from Petitioner. The Florida Medicaid Program is administered through Respondent. In order to receive federal matching funds, Respondent must implement certain mandatory services for indigent. Other services which may qualify for federal funds are optional, and the state may cheese not to implement those programs. The pharmacy program, which this rule purports to regulate, is one such optional service which the State of Florida has chosen to implement. Funds utilized in the Medicaid Program are controlled by the legislature through funding of Respondent's budget. To regulate its budget, Respondent regularly reviews utilization and implements cost containment in various program. In 1981, Respondent was required to reduce its budget, and approximately $2 million of that reduction was required to be made in the Medicaid Program. In considering various options to reduce the Medicaid budget by this amount, the Department reviewed the pharmacy program budget which is the third largest in the Medicaid Program. Options such as limiting the number of prescriptions and requiring full payment were considered since these options had been implemented in other states. Such restrictions were not initiated, however, because Respondent felt that the large elderly population in Florida would forego taking necessary medication and endanger their health. Specific medications which were being paid for through the prescribed drug program were reviewed and certain drugs were eliminated from reimbursement under the program when prescribed for specified reasons, and other drugs were eliminated completely. These categories eliminated were chosen which would have the least detrimental effect on recipients. Additionally, Respondent, in consultation with physicians and pharmacists, considered the use of nonsteroidal anti-inflammatory drugs for the treatment of arthritis. While the drug of choice for treatment of arthritis is aspirin, because it is more effective than most nonsteroidal anti-arthritics, these nonsteroidal anti-arthritic drugs may be necessary for some patients who can't take aspirin. The number of persons who require such drugs instead of aspirin is small, however, and would not justify the large percentage of prescriptions for the nonsteroidal anti-arthritics which Respondent had observed through administering the pharmacy program. Because of their relatively high cost, nonsteroidal anti-arthritic drugs were accounting for 9.6 percent of the pharmacy program budget. Instead of eliminating the entire category of nonsteroidal anti- arthritic drugs from reimbursement under the program, which some states have implemented, Respondent opted to add aspirin to the list of covered benefits when prescribed for arthritis, and to require that the term "medically necessary" be written by the physician on the prescription form for nonsteroidal anti- arthritic drugs in order to be eligible for Medicaid reimbursement. This procedure was initiated in an effort to direct physicians' attention to the cost differential between the two types of drugs to ensure that a physician was making a conscious decision when prescribing the more expensive nonsteroidal anti-arthritic medication. The term "medically necessary" was chosen because physicians were familiar with that phrase through its use under the Florida Generic Drug statute. In response to an inquiry from the Florida Medical Association concerning the use of the term "medically necessary, Respondent indicated to that group that the term "drug of choice" would be an acceptable alternative. The challenged rule had not been amended at the time of final hearing in this cause to reflect this alternative term, nor was there any indication of record that any group other than the Florida Medical Association had been notified of Respondent's policy choice in this regard.
