The Issue Whether Respondent, a licensed nutritional counselor, committed the offenses alleged in the administrative complaint and the penalties, if any, that should be imposed.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of nutritional counseling pursuant to Section 20.42, Florida Statutes; Chapter 455, Florida Statutes, and Chapter 468, Florida Statutes. Respondent was licensed as a nutritional counselor at all times pertinent to this proceeding. Respondent was issued license number NC 0000427 in 1990. At the time of the formal hearing, Respondent’s address was 6661 Royal Palm Boulevard, Margate, Florida 33063-2108. At all times pertinent to this proceeding, C. B. was a female cancer patient of Franciso Bellette, M.D., a physician specializing in the field of oncology. Before Dr. Bellette moved to Florida in 1993, C. B. was treated by another physician in the practice group that Dr. Bellette subsequently joined. Prior to 1993, C. B. had chemotherapy, which she tolerated poorly. In October 1995, Dr. Bellette diagnosed C. B. as having Stage 4 breast cancer with bony metastasis. Although the preferred treatment was chemotherapy, C. B. refused further chemotherapy because of her poor prior experience with chemotherapy. As the alternative treatment, Dr. Bellette prescribed the drug Tamoxifen for C. B., and she began taking that medicine. Tamoxifen has been used to treat cancer patients for several years. There are documented side effects and risks associated with taking the drug. Dr. Bellette was aware of those side effects and risks and explained them to C. B. before she began taking Tamoxifen. It was Dr. Bellette’s opinion that for C. B. the benefits of taking Tamoxifen outweighed the known side effects and risks. In January 1996, C. B. traveled to Mexico to investigate an alternative treatment plan that included special diets. Because of the language barrier, she was not certain she understood the nutritional counseling she had received in Mexico. After she returned from Mexico, C. B. made an appointment with Respondent to discuss her nutritional needs. C. B. and Respondent met only on one occasion in late January or early February 1996. Respondent’s nutritional counseling typically includes three visits. The first visit is typically an informal meeting during which he explains nutritional counseling to the prospective client, which includes a discussion as to the client’s nutritional needs and goals. If the client wants to continue with the other two visits, Respondent prepares and thereafter implements a nutritional plan for the client. C. B. decided that she did not want to pursue the other two visits with Respondent. Consequently, Respondent did not prepare a nutritional assessment of C. B., did not prepare a nutritional plan for C. B., and did not become her nutritional counselor. During his meeting with C. B., Respondent discussed her illness and the fact that she was taking Tamoxifen. C. B. testified in her deposition that Respondent told her that Tamoxifen was a killer drug and that she should stop taking the drug. C. B. also testified that she was sure Respondent had told her to stop taking Tamoxifen. Respondent testified, credibly, that he did not tell C. B. to stop taking Tamoxifen, but that he discussed the drug and its severe side effects with her so she could make an informed decision as to her course of treatment. C. B. was in hospice at the time of her deposition and heavily medicated. C. B. readily conceded that the medication she was on impaired her memory. It is not clear whether C. B. accurately recalled the statements made by Respondent, as opposed to recalling her interpretation of what Respondent had said. This conflict in the evidence is resolved by finding that Respondent discussed with C. B. the severe side effects of Tamoxifen in a manner designed to discourage C. B. from taking the medicine. The testimony of C. B. is insufficient to establish by clear and convincing evidence that Respondent told her to stop taking Tamoxifen. Respondent did not hold himself out as a physician or as a pharmacist.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order that adopts the findings of fact and conclusions of law contained herein. It is further recommended that the final order dismiss the administrative complaint against Respondent. DONE AND ENTERED this 5th day of June, 1997, in Tallahassee, Leon County, Florida. Hearings Hearings CLAUDE B. ARRINGTON Administrative Law Judge Division of Administrative The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative this 5th day of June, 1997
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.
The Issue The issues are whether Respondents committed the acts or omissions alleged in four administrative complaints, and, if so, what penalty should be imposed against Respondents' licenses.
Findings Of Fact Petitioner proved the grounds alleged in paragraphs 1 through 3 of each Amended Complaint and the grounds alleged in paragraphs 1 through 5 of each Administrative Complaint. Petitioner is the state agency responsible for regulating the practice of pharmacy in Florida pursuant to Section 20.43 and Chapters 456 and 465. Rx and Gordon are each licensed in Florida, respectively, as a community pharmacy and pharmacist pursuant to license numbers PH 17718 and PS 27618. Rx is a community pharmacy located at 5400 South University Drive, Suite 107, Davie, Florida 33328. Gordon is the pharmacy manager. Rx operates an Internet pharmacy. Rx fills prescriptions received over the Internet and dispenses the prescribed medications. A website company identified in the record as USAPrescriptions.com (USAP) obtains personal information from individuals responding to USAP advertisements on the Internet. USAP transmits the patient information to physicians who prescribe medication for the individuals and transmit the prescriptions and patient information to Rx by e-mail. Rx prints a written record of the electronically transmitted prescription, but the written record of the prescription is not the actual prescription. Rx then enters the patient information into its computer system; fills the prescription; labels the medication in accordance with the requirements of Section 893.04(1)(e); obtains a written confirmation of the prescription from the physician; and dispenses the medication to the patient by private courier. Petitioner conducted on-site inspections of Rx on April 6 and October 18, 2001. Petitioner proved the grounds alleged in paragraph 4(b) of the Amended Complaints. Many of the medications in evidence are controlled substances within the meaning of Section 893.03. None of the controlled substances are Schedule I or Schedule II drugs defined in Section 893.03(1) and (2). Most of the medications are Schedule III, IV, or V drugs defined in Section 893.03(3)-(5). The remaining medications are legend drugs that are not scheduled by statute. Most of the medications in evidence are controlled substances identified in the record as obesity drugs and marketed under the brand names Adipex, Bontril, Didrex, Ionamin, Meridia, Phentermine, and Tenuate. Other medications include Celebrex, Ultram, Valtrex, Viagra, Xenical, and Zyban. Petitioner failed to prove the allegation in subparagraph 4(a) of the Amended Complaints that Respondents filled prescriptions written by out-of-state physicians who prescribed medication based on Internet questionnaires. Rx and Gordon do not fill "written" prescriptions. Respondents fill electronic prescriptions that physicians transmit by e-mail. The electronic prescriptions are transmitted by "other means of communication" authorized in Section 893.02(20). Respondents reduce each electronic prescription to a written record referred to in Section 893.04(1)(a). The evidence is not clear and convincing that physicians prescribe based on Internet questionnaires. None of the prescribing physicians testified. The content of the Internet questionnaire is not established by clear and convincing evidence. The prescribing physicians provide Respondents with patient profiles that include medical information for each patient. Evidence that the patient profiles are an inadequate basis for the prescriptions is less than clear and convincing. Petitioner's experts relied on the adequacy of the patient profiles, in relevant part, to opine that Respondents failed to properly consult patient profiles before dispensing obesity drugs. Evidence that patient profiles were an adequate source of medical information to consult before dispensing drugs is inconsistent with allegations that the patient profiles received from the prescribing physicians were an inadequate basis for the prescription or that the Internet questionnaires did not include sufficient information. Inconsistent evidence and allegations are not clear and convincing. The allegation in paragraph 4(a) that an "out-of-state physician" transmitted the referenced prescription is not material to the statutory mandate for Respondents to determine the validity of the prescription. The statute requires a pharmacist to determine the validity of the prescription only when the prescribing physician is "licensed" in a state other than Florida. The physical location of the physician is immaterial. The trier of fact cannot infer that Petitioner intended to allege a material fact. The fact must be alleged in the plain language of the Amended Complaint. It may be reasonable for the fact-finder to infer that the physician is licensed in the state where he or she is located, but such an inference is less than clear and convincing. The ALJ has ruled that any ambiguity in the factual allegation must be construed in favor of the licensee because this is a license discipline proceeding. The evidence is less than clear and convincing that Gordon was present at Rx on April 6, 2001. The investigator's testimony that he interviewed Gordon on April 6, 2001, is not persuasive. That testimony conflicts with evidence that the investigator customarily documents interviews in his investigative report and did not document an interview with Gordon on April 6, 2001. Such inconsistent evidence is less than clear and convincing. Even if Gordon were found to be present during the inspection, the evidence does not show how long she was present or the nature and scope of her personal conduct concerning the alleged acts or omissions. The evidence is less than clear and convincing that the alleged acts or omissions were caused by misconduct on the part of Rx. The alleged acts or omissions are limited to April 6, 2001. Evidence relevant to the inspection conducted on April 6, 2001, consists primarily of the testimony of one inspector and two exhibits. The evidence is insufficient to show that unidentified employees of Rx engaged in the alleged acts or omissions in a persistent and practiced manner. The evidence is insufficient to support an inference that Rx is vicariously responsible for the alleged acts or omissions of its employees on April 6, 2001. Paragraph 4(c) in the Amended Complaints alleges that the prescriptions filled by Respondents were not valid because there was no patient-physician relationship upon which to base a treatment plan or "to justify prescribing medications." The evidence does not establish standards applicable to Respondents. The investigator's testimony makes clear that the alleged grounds are based on a rule promulgated by the Board of Medicine that is applicable only to physicians licensed in Florida. The ALJ has ruled in the Conclusions of Law that Petitioner has no jurisdiction to discipline Respondents for violating a rule applicable to physicians. No further findings are made concerning the grounds alleged in the Amended Complaints. Paragraph five in the Amended Complaints charges a violation based on facts alleged in the preceding four paragraphs of the complaint. The remaining references in the Recommended Order to a "paragraph" refer to paragraphs in the Administrative Complaints. Paragraph 5 alleges that the "inspection team observed" four technicians and one pharmacist dispensing medications on October 18, 2001, in violation of the maximum ratio of 3:1 prescribed in Section 465.014. The observations of the "inspection team" are a method of proof but, in this instance, include the fact sought to be proven. On October 18, 2001, Gordon was the only pharmacist on duty during the inspection. Four other employees were present at the time, but the evidence is less than clear and convincing that all four employees were technicians. Two members of Petitioner's inspection team found that Respondents maintained the correct ratio. One member is a licensed pharmacist. A third member found the ratio to be improper. Such inconsistent evidence is less than clear and convincing. As to paragraph 6, Petitioner proved that mislabeled drugs were present in the offices of Rx on October 18, 2001. The evidence is clear and convincing that a potentially dangerous pre-packaging procedure occurred on that day. The deficient procedure failed to properly label medications during the re-packaging process. The evidence of personal misconduct by Gordon on October 18, 2001, is less than clear and convincing. Although Gordon was present during the inspection, there is little detailed evidence of her personal conduct. The facts are similar for Rx. The evidence is less than clear and convincing that Rx directed its employees to commit the deficiencies or knew of the deficiencies. Uncontroverted admissions by Rx employees indicate they were instructed to use the deficient procedure to label vials. However, the evidence is insufficient to show that the instructions came personally from Gordon, the owners of Rx, or some other employee or manager. The evidence does not support an inference by the trier of fact that Rx or Gordon is vicariously responsible for the deficiencies. The evidence is insufficient to show that the labeling deficiencies on October 18, 2001, were persistent and practiced. The allegation is limited to a specific day, and the inspection team was not in the offices of Rx all day. The evidence established the standards required for Respondents to exercise due care. The medications were improperly labeled in vials loaded in bins prior to the time that an employee filled a specific prescription. The bins were labeled with the name of the medication and the number of pills. However, the vials did not contain a label stating the strength of the drug, dosage form, manufacturer's lot number or control number, and expiration date as required in Section 499.006(3) and Rule 64F-12.006(1). The standard of care is that the vials must be labeled with the requisite information before filling the vial rather than afterward. The potential for harm from mislabeled drugs is great. It is unsafe and dangerous to keep unlabeled prescription vials containing medications. However, the evidence is not clear and convincing that any actual harm occurred. No finding is made concerning the grounds alleged in paragraph 7. If the facts expressly alleged in paragraph seven were proven, those grounds would not prove any of the remaining charges. Paragraph 7 alleges virtually every fact related to the misuse of a Kirby-Lester machine except that Respondents actually misused the machine by not cleaning it after counting one type of medication and before counting a different type of medication. The allegation is that contamination can occur if the machine is not cleaned between medications. Paragraph 7 does not allege that any member of the inspection team observed Respondents using the machine to count different medications without cleaning the machine between medications. The trier of fact cannot draw an inference that facts not expressly stated were intended to be alleged. The allegation must appear in the plain language of the paragraph. Petitioner failed to prove the grounds alleged in paragraph 8. The evidence is less than clear and convincing that Respondents prepared, packaged, or held drugs under conditions that could contaminate the drugs with filth or render the drugs injurious to health. The evidence is less than clear and convincing that the drugs and drug packaging material referred to in the allegation were part of the dispensing process. The materials were being held for return to the manufacturer. Petitioner submitted no evidence showing that Respondents used the empty vials or vial tops to package medications or that Respondents actually dispensed pills that had been dropped on the floor. The evidence of Gordon's personal conduct concerning the alleged grounds is less than clear and convincing. The evidence does not show that the acts or omissions occurred in a persistent and practiced manner. The evidence is less than clear and convincing that Rx operated an unsanitary, unsafe, or unclean pharmacy or that Gordon managed such a pharmacy. It is reasonable for a busy pharmacy to accumulate debris and clutter on the floor in the course of a busy day. Routine clutter does not render a pharmacy unsafe, unclean, or unsanitary. Petitioner proved the allegation in paragraph 9 that unnamed employees at Rx received approximately 764 prescriptions on October 5, 2001, and that the prescriptions were not signed. Petitioner failed to prove that the prescriptions were written and required by law to be signed. The unsigned documents are not prescriptions within the meaning of Section 893.02(20). They are the written record of prescriptions that are transmitted electronically over the Internet. Paragraph 9 refers to Rule 64B8-9.012(4). That rule is promulgated by the Board of Medicine and applies to physicians. Respondents are not physicians. Petitioner proved part of the grounds alleged in Paragraph 10 but failed to prove a material ground. No finding is made regarding the remaining ground. Petitioner proved that Section 893.02(20) contains the provision quoted in paragraph 10. For reasons stated in paragraphs 9 through 11 of the Findings of Fact, evidence of the basis upon which the prescribing physicians ordered medications is less than clear and convincing. No finding is made concerning the allegation that "many of these . . . controlled substances . . . were prescribed. . . ." The prescribing physicians did not testify, and Respondents do not prescribe medications. Respondents fill prescriptions and dispense medications. No finding is made concerning paragraph 11. Paragraph 11 does not allege that Respondents committed any specific act or omission. Paragraph 11 recites Section 465.003(14). No finding is made concerning paragraphs 12 and 13. The grounds alleged in both paragraphs pertain to physicians rather than pharmacists. In relevant part, paragraph 14 alleges: Accordingly, Respondent is dispensing obesity medications prescribed without benefit of a valid patient/physician relationship in violation of Section 465.016(1)(i). . . For purposes of Section 465.016(1)(i) . . ., it shall be legally presumed that the . . . dispensing of . . . drugs in excessive or inappropriate quantities is not in . . . the course of the professional practice of pharmacy. Also, the practice constitutes violations of sections 894.04(1) and 893.02(20). . . for dispensing controlled substances outside the course of the professional practice of pharmacy by failing to determine whether the prescriptions were issued pursuant to a valid patient/physician relationship, and by failing to determine that the drugs so ordered are considered necessary for the continuation of treatment of a chronic or recurrent illness. (emphasis supplied) Paragraph 14 charges that Respondents violated the referenced statutes based on antecedent facts alleged in paragraphs 9 through 13 and incorporated by reference through terms such as "accordingly" and "the practice." Related counts in paragraphs 66-88 or 90 contain substantially similar charges based on facts alleged in paragraphs 1-65. The charges in paragraph 14 and related counts are read together to include relevant factual allegations in paragraphs 1-65. Section 893.02(20), in relevant part, requires a pharmacist to determine whether prescriptions from a physician licensed in a state other than Florida are issued pursuant to a valid patient-physician relationship, are authentic, and are necessary for the continuation of treatment of a chronic or recurrent illness (the validity test). The terms of the validity test are susceptible to different interpretations. The validity test could be construed to require a pharmacist to determine whether the physician considers the patient-physician relationship to be valid, the prescription authentic, and the drugs necessary. Alternatively, the validity test could require the pharmacist to substitute the pharmacist's judgment for that of the physician. The ALJ has determined that any ambiguity in the terms of the validity test must be construed in favor of Respondents and against the imposition of discipline. The ALJ has also determined that a requirement for a pharmacist to substitute her or his judgment to determine the medical necessity of medication may, in some cases, require the licensee to practice medicine. Respondents exercise reasonable care to ensure that the validity test has been satisfied, when applicable, by requiring the prescribing physician to sign a written verification of the prescriptions ordered by that physician. Respondents do not fill any prescription before Respondents receive a "site fill list" or "daily log" signed by the prescribing physician to verify the authenticity of the prescription, the validity of the patient-physician relationship, and the medical necessity of the medication. If pharmacists were required to substitute their judgment for that of prescribing physicians, the standards for exercising that judgment are less than clear and convincing. The requirement for a licensee to determine the validity of the patient-physician relationship applies only if the physician is licensed in a state other than Florida. Standards used to determine the validity of a patient-physician relationship vary from state to state. Clear and convincing evidence does not indicate whether a Florida pharmacist must apply Florida law to make the necessary determination or must apply the law of the state where the prescribing physician is licensed. Petitioner relies on an unwritten agency statement by the Board of Pharmacy to explicate the standards that pharmacists must use in determining the validity of a patient- physician relationship. The agency statement requires licensees to determine whether a prescribing physician, licensed in any state including Florida, has conducted an in-person examination of the patient prior to prescribing a medication. The agency statement holds that the absence of an in-person examination renders the prescription invalid. Findings pertaining to the agency statement are discussed further in the Conclusion of Law because continuity requires a simultaneous discussion of both findings of fact and conclusions of law. The charge in paragraph 14 that Respondents dispense excessive or inappropriate quantities of legend drugs is equivalent to charges in Count Two against Rx and Count Four against Gordon. Facts relevant to those charges are alleged in paragraphs 9, 15, 16, 17, and 20 through 22 of the Administrative Complaints. Paragraphs 25, 26, and 29 in the Administrative Complaint against Rx allege additional relevant facts, as do paragraphs 26, 27, and 30 in the Administrative Complaint against Gordon. In relevant part, paragraph 9 alleges that on October 5, 2001, Respondents received 764 prescriptions from three physicians identified in the record as Drs. Rosenkrantz, Rivera, and Thompson. Paragraphs 15 through 17 allege that two drugs marketed under the names Phentermine and Bontril are controlled substances that have a high potential for abuse. Respondents stipulated to paragraphs 15 through 17. Paragraph 20 alleges that many of the controlled substances are for a three-months' supply per purchase. Paragraph 21 alleges that the PDR states that tolerance for the anorectic effect of many obesity drugs occurs after a "few weeks," and that the drug should be discontinued at that time rather than increased to overcome tolerance. Paragraph 22 alleges that Respondents filled hundreds of prescriptions for obesity drugs each day included in the business practices described in paragraphs 1 through 21. The business practices described in paragraphs 1 through 21 are for the dates that occurred from October 5 through 18, 2001. Paragraphs 25 and 26 pertaining to Rx, and paragraphs 26 and 27, pertaining to Gordon, allege that Petitioner's investigator obtained the written record of additional prescriptions when an employee for Rx produced the documents on October 24, 2001. Paragraph 29, pertaining to Rx, and paragraph 30, pertaining to Gordon, allege that the computer operated by Rx showed that Rx and its employees dispensed 17,410 tablets of Phentermine on December 5, 2001; and that a daily log dated September 4, 2001, showed that Rx employees received 300 prescriptions from Dr. Rivera. The facts alleged to support the charges of dispensing excessive or inappropriate quantities of legend drugs involve dates from September 4 through December 6, 2001 (the relevant period). Within the relevant period, the enumerated paragraphs together allege that Rx and Gordon dispensed excessive and inappropriate quantities of legend drugs including: hundreds each day; 17,410 tablets on December 5, 2001; and 300 from Dr. Rivera on September 4, 2001. The relevant paragraphs also allege that many of the legend drugs were obesity drugs such as Bontril and Phentermine; and that many drugs were dispensed pursuant to prescriptions for 90 days' supply per purchase. The relevant paragraphs further allege methods of proof, including documents received on October 24, 2001, provisions of the PDR, and documents collected by the inspectors. The evidence is less than clear and convincing that Gordon personally dispensed drugs during the relevant period. There is insufficient evidence, or allegations, to show when Gordon was present at the pharmacy, for how long, or if her duties required her to fill prescriptions and dispense drugs. The evidence is less than clear and convincing that Gordon is vicariously responsible for drugs that others dispensed during the relevant period. Although the evidence is clear that drugs were dispensed in a persistent and practiced manner, there is insufficient evidence for the trier of fact to draw an inference that Gordon was vicariously responsible. Petitioner did not prove that Gordon was the only manager during the relevant period. Paragraph 5 of the Administrative Complaints alleges that, on October 18, 2001, Gordon identified another person present at the pharmacy as the owner. The next allegations concerning Gordon's management control over pharmacy operations pertain to the inspection conducted on January 31, 2002. The allegations and evidence are insufficient to differentiate the duties of Gordon and others with management control. The evidence is insufficient to show which days various managers were present, what specific duties each performed, and how the managers allocated management responsibilities among themselves. The evidence is less than clear and convincing that Gordon had any management control over those who dispensed medications during the relevant period. There is no doubt that Rx dispensed large quantities of medication during the relevant period. Employees at Rx dispensed approximately 1,942 legend drugs during the relevant period. That is a practiced and persistent manner of dispensing drugs regardless of which employees dispensed the drugs. Large quantities of drugs are not necessarily excessive or inappropriate quantities. Petitioner stipulated during the hearing that a determination of whether quantities are excessive or inappropriate must be made "per patient" and not by reference to the pharmacy. The evidence of prescriptions filled by Rx consists of Petitioner's Exhibits 59, 62, 63, 76, 77, 87, 88, 90, 92, and 94 (P59, P62, etc.). The prescriptions were filled from January 11, 2001, through April 26, 2002. Prescriptions evidenced in P87, P88, and P92 are outside the relevant period. Of the remaining prescriptions, the prescriptions that are essential to the opinion of Petitioner's expert are set forth in P94. That exhibit consists of a Site Fill List, or daily log, maintained by Rx for the period from September 4 through October 10, 2001. Petitioner's expert identified 102 instances in P94 in which he opined that medications were dispensed to individual patients in excessive or inappropriate quantities. The instances relied on by Petitioner's expert may be fairly summarized as follows: Item Date Patient Drug Dose/Quantity 1. 9/20 L.A. Phentermine(P) 30mg/30 2. 9/20 L.A. P 30mg/30 3. 9/20 L.W. P 30mg/90 4. 9/20 L.W. Meridia (M) 15mg/90 5. 9/4 K.Co. Diethylpropion(DP) 75mg/90 6. 9/4 K.Cu P 30mg/90 7. 9/10 A.J. Adipex (A) 37.5mg/90 8. 9/10 A.J. Didrex (D) 50mg/30 9. 9/10 A.J. Adipex (A) 37.5mg/90 10. 9/10 A.J. Didrex (D) 50mg/30 11. 9/11 D.B. Bontril (B) 105mg/90 12. 10/2 D.B. B 105mg/90 13. 10/2 K.Sg. P 15mg/90 14. 10/1 K.Sg. P 30mg/90 15. 9/4 I.To. P 30mg/30 16. 9/26 I.To. P 37.5mg/90 17. 10/1 I.Tr. A 37.5mg/90 18. 10/5 I.Tr. A 37.5mg/90 19. 10/3 I.Tr. Celebrex 200mg/50 20. 10/5 I.Tr. Xenical 120mg/270 21. 9/10 D.Ha. A 37.5mg/90 Item Date Patient Drug Dose/Quantity 22. 9/6 D.Ha. P 30mg/90 23. 10/10 J.H. M 10mg/30 24. 10/5 J.H. P 30mg/90 25. 9/6 D.Ht. D 50mg/30 26. 9/7 D.Ht. D 30mg/30 27. 9/28 L.M. Viagra 100mg/30 28. 9/28 L.M. Viagra 100mg/30 29. 9/5 J.S. P 30mg/30 30. 9/24 J.S. P 30mg/30 31. 10/1 J.S. P 30mg/90 32. 9/25 Z.H. P 30mg/30 33. 9/25 Z.H. P 30mg/30 34. 9/5 D.I. A 37.5mg/30 35. 9/6 D.I. A 37.5mg/30 36. 10/10 L.Z. D 50mg/90 37. 10/8 L.Z. P 30mg/90 38. 9/17 T.W. A 37.5mg/30 39. 9/14 T.W. P 37.5mg/90 40. 9/20 L.A. P 30mg/30 41. 9/20 L.A. P 30mg/30 42. 9/17 A.E. P 30mg/30 43. 9/24 A.E. P 30mg/90 44. 9/27 D.P. A 37.5mg/90 45. 9/26 D.P. P 30mg/90 46. 10/5 K.Sh. A 37.5mg/30 47. 10/5 K.Sh. P 37.5mg/30 48. 10/5 P.S. P 30mg/90 49. 9/27 P.S. P 37.5mg/30 50. 9/10 M.F. P 30mg/90 51. 9/10 M.F. P 30mg/90 52. 9/24 A.G. A 37.5mg/30 53. 9/6 A.G. B 105mg/30 54. 9/4 B.A. DP 75mg/30 55. 9/4 B.A. DP 75mg/30 56. 9/17 M.S. P 37.5mg/90 57. 9/20 M.S. P 37.5mg/90 58. 10/9 V.S. P 30mg/90 59. 9/24 V.S. P 37.5mg/90 60. 9/17 D.Cd. P 37.5mg/90 61. 9/4 D.Cf. P 37.5/90 62. 9/26 J.Ws. P 30mg/90 63. 9/27 J.Ws. P 37.5mg/90 64. 9/25 R.R. B 105mg/30 65. 9/24 R.R. B 105mg/90 66. 9/10 A.J. A 37.5mg/90 Item Date Patient Drug Dose/Quantity 67. 9/10 A.J. D 50mg/30 68. 9/28 K.J. P 30mg/90 69. 10/1 K.J. P 30mg/90 70. 9/12 S.F. P 30mg/30 71. 9/12 S.F. P 30mg/30 72. 10/3 S.F. P 30mg/30 73. 10/3 D.M. A 37.5mg/30 74. 10/5 D.M. A 37.5mg/30 75. 9/14 P.G. DP 75mg/30 76. 9/14 P.G. DP 75mg/90 77. 9/17 M.I. P 30mg/30 78. 9/21 M.I. P 30mg/90 79. 9/19 T.H. Viagra 100mg/20 80. 9/18 T.H. Viagra 100mg/30 81. 9/12 C.C. Ionamin (I) 30mg/90 82. 9/5 C.C. P 37.5mg/30 83. 9/21 M.P. D 50mg/30 84. 9/25 M.P. D 50mg/90 85. 9/4 K.H. A 37.5mg/30 86. 9/28 K.H. A 37.5mg/30 87. 10/10 K.H. A 37.5mg/30 88. 10/3 A.C. Viagra 100mg/10 89. 10/3 A.C. Viagra 100mg/10 90. 9/24 K.K. P 37.5mg/30 91. 10/2 K.K. P 37.5mg/90 92. 9/6 J.Wi. A 37.5mg/30 93. 9/19 J.Wi. D 37.5mg/30 94. 9/5 T.W. A 37.5mg/30 95. 9/19 T.W. A 37.5mg/30 96. 10/8 T.W. A 37.5mg/30 97. 9/28 A.M. P 30mg/30 98. 10/9 A.M. P 30mg/30 99. 9/17 S.K. Viagra 100mg/10 100. 9/17 S.K. Viagra 100mg/10 101. 10/5 C.K. Ultram 50mg/30 102. 10/8 C.K. ULtram 50mg/90 The appropriateness of a quantity of medication is determined by reference to the medical profile of a particular patient. The evidence is less than clear and convincing that the quantities of dispensed medication were inappropriate. Evidence and allegations concerning patient profiles are inconsistent. Petitioner alleges in its complaints that information in patient profiles provided an insufficient basis for the prescribing physician to order medication. However, witnesses for Petitioner opined that Respondents deviated from the professional practice of pharmacy by failing to consult the profiles. The necessary implication is that the profiles contained sufficient medical information for Respondents to consult before dispensing medication. There would be no rational reason to consult an invalid patient profile. Other evidence suggests the patient profiles contain insufficient medical information. The apparent inconsistency was confusing, contributed to a hesitance in the mind of the trier of fact that either proposition was true, and eroded the credibility of expert testimony that Rx employees dispensed medication in inappropriate quantities to particular patients. A medication is dispensed in an excessive quantity if the quantity dispensed exceeds the maximum recommended quantity for the medication. Petitioner cited no statute or rule that defines the term "quantity." The plain and ordinary meaning of the "quantity" of a drug is the "measurable [or] countable . . . property" of the drug. The American Heritage Dictionary of the English Language, 1432 (4th ed. 2000). The trier of fact measured the total medication dispensed pursuant to a single prescription by the total milligrams of medication dispensed. Rx employees dispensed obesity drugs evidenced in P94 in the form of pills. The total medication dispensed by pill is a mathematical product equal to the strength of each pill multiplied by the number of pills, including refills. The evidence is less than clear and convincing that prescriptions in P94 included refills. Petitioner cited no statute or rule that identifies the maximum recommended quantity for the obesity drugs at issue. Rather, a combination of expert testimony and the maximum strengths evidenced in P94 establish a maximum recommended quantity for the obesity drugs at issue. The trier of fact determined that obesity drugs in P94 were dispensed in excessive quantities if the total medication dispensed to a patient within 90 days exceeded the total medication in 90 pills, at the maximum strength for each pill, taken once a day for 90 days (the 90-day standard). Evidence of which obesity drugs have a lower quantity standard is less than clear and convincing. It is clear, however, that any of the obesity drugs in P94 are dispensed in excessive quantities if the total dispensed medication exceeds the total medication in the 90-day standard. The evidence is less than clear and convincing that the total dispensed medication was excessive in item numbers 1, 2, 7 through 10, 40, 41, 66, and 67. Items 1, 2, 40, and 41 may be duplicates as may be the case for items 8, 10, and 67; and 7, 9, and 66. The trier of fact has sufficient doubt as to whether the opinions based on the enumerated items are true. The evidence is less than clear and convincing that the total dispensed medication was excessive in items 19, 20, 27, 28, 79, 80, 88, 89, and 99 through 102. Those items show that the medications are not obesity drugs. Evidence of the quantity standards for legend drugs other than obesity drugs is less than clear and convincing. The evidence is less than clear and convincing that total dispensed medication was excessive in connection with items 5, 6, 25 and 26, 32 through 35, 46 and 47, 52 through 55, 60, 61, 70 through 74, 85 through 87, and 92 through 98. Patient names in items 5 and 6 and 60 and 61 are different. Where patient names are the same for two prescriptions, the total medication dispensed pursuant to both prescriptions does not exceed the 90-day standard. The evidence is clear and convincing that the total dispensed obesity medication exceeded the 90-day standard in several instances. Those instances are evidenced in items 3 and 4, 11 through 18, 21 through 24, 29 through 31, 36 through 39, 42 through 45, 48 through 51, 56 through 59, 62 through 65, 68 and 69, 75 through 78, 81 through 84, and 90 and 91. Neither the strength of each pill nor the number of pills dispensed pursuant to a single prescription caused total dispensed medication to exceed the total medication in the 90- day standard. Total dispensed medication generally exceeded total medication in the 90-day standard when employees dispensed an obesity drug to a patient pursuant to a second prescription within 90 days of the first. In items 29 through 31, however, the excess occurred when obesity drugs were dispensed pursuant to a third prescription in item 31 within 90 days of the first two prescriptions in items 29 and 30. Therefore, the 49 items enumerated in the preceding paragraph evidence only 24 instances of excessive quantities of obesity drugs. The total dispensed medication exceeded the total medication in the 90-day standard in three types of fact patterns. In one fact pattern, Rx employees dispensed the same brand name obesity drug to a patient at the maximum strength pursuant to two prescriptions within 90 days. In item 11, for example, Rx employees dispensed 90 pills of Bontril at the maximum strength of 105 milligrams per pill. In item 12, they dispensed the same quantity approximately 22 days later. The total dispensed medication within 90 days is equal to the product of 180 pills multiplied by 105 milligrams, or 18,900 milligrams. The total medication in the 90-day standard is 90 pills at 105 milligrams, or 9,450 milligrams. The excessive quantity is the excess of the dispensed medication (18,900) over the medication in the 90-day standard (9,450). The excessive quantity evidenced in items 11 and 12 is 9,450 milligrams. By similar calculations, the excessive quantity in items 56 and 57 is 3,375 milligrams. The excessive quantity in items 64 and 65 is 3,150 milligrams. In items 75 and 76, 83 and 84, and 90 and 91, the excessive quantities are 2,250, 1,500, and 1,125 milligrams, respectively. In the second fact pattern, Rx employees dispensed the same brand name obesity drug to a patient at less than the maximum strength pursuant to two or more prescriptions within 90 days. In item 14, for example, Rx employees dispensed 90 pills of Phentermine at a strength of 30 milligrams per pill. In item 13, they dispensed 90 pills of the same drug the next day at 15 milligrams per pill. The total medication dispensed within 90 days is equal to the sum of the total milligrams dispensed in each instance, or 4,050 milligrams. The total medication in the 90-day standard is 90 pills at 37.5 milligrams, or 3,375 milligrams. The excessive quantity is the excess of the dispensed medication (4,050) over the medication in the 90-day standard (3,375). The excessive quantity evidenced in items 13 and 14 is 675 milligrams. By similar calculations, the excessive quantities in items 15 and 16, 29 through 31, 42 and 43, 48 and 49, 50 and 51, 58 and 59, 62 and 63, 68 and 69, and 77 and 78, respectively, are 900, 1,125, 225, 450, 2,025, 2,700, 2,700, 2,025, and 225 milligrams. In the third fact pattern, Rx employees dispensed different brand name obesity drugs in different strengths pursuant to two prescriptions within 90 days. In item 3, for example, Rx employees dispensed 90 pills of Phentermine at 30 milligrams per pill. In item 4, they dispensed 90 pills of Meridia on the same day at 15 milligrams per pill. The total medication dispensed within 90 days is equal to the sum of the milligrams dispensed in each instance, or 4,050 milligrams. The total medication in the 90-day standard is 90 pills at 37.5 milligrams, or 3,375 milligrams. The excessive quantity is the excess of the dispensed medication (4,050) over the medication in the 90-day standard (3,375), or 675 milligrams. By similar calculations, the excessive quantities in items 21 through 24, 36 through 39, 44 and 45, and 80 and 81, respectively, are 2,975, 1,575, 2,700, and 450 milligrams. Rx employees dispensed obesity drugs in the three fact patterns just discussed in an aggregate excessive quantity of 42,275 milligrams. The average excessive quantity for each of the 24 instances found in P94 is 1,761 milligrams. The average excess quantity correlates to a 90-day excess of approximately 17 pills at a maximum strength of 105 milligrams, 23 pills at 75 milligrams, 35 pills at 50 milligrams, 47 pills at 37.5 milligrams, and 117 pills at 15 milligrams. The ALJ has concluded that Section 465.016(1)(i) creates a legal presumption that the excessive quantities of obesity drugs dispensed by Rx employees were not dispensed in the course of the practice of pharmacy. Rx did not rebut the statutory presumption with persuasive evidence that explains the quantities of medications dispensed or rebuts the quantity standards in evidence. Respondents' expert relied on substantially the same evidence as that relied on by Petitioner's expert and opined that Respondents dispensed medication in accordance with the professional practice of pharmacy. However, that opinion was an ultimate conclusion that was not fact specific and did not cast doubt on the details that gave rise to the statutory presumption. That opinion was not persuasive. Rx argues that Petitioner did not show that the prescriptions were actually filled, did not sufficiently identify the patients, and did not show that the patients actually received the medications. Those arguments are neither credible nor persuasive. They do not create a hesitance in the mind of the trier of fact concerning the details supporting the statutory presumption. Information in P94 is part of the QS1 system. The instances of excessive quantities of medications provide a sufficient basis for the trier of fact to find that Rx is vicariously liable for Rx employees who dispensed obesity drugs in excessive quantities in the 24 instances evidenced in P94. The instances are not isolated events. During the 26 days evidenced in P94, the 24 instances of excessive quantities occurred, on average, almost once a day. That evidence shows that Rx employees dispensed excessive quantities of obesity drugs in a persistent and practiced manner. Rx did not require its employees to comply with the standard of conduct evidenced in expert testimony. In the absence of an adequate alternative, Rx employees must personally review site fill lists to ensure that quantities are not excessive. Rx employees do not personally review site fill lists. Rather, Rx permits its employees to rely on the QS1 computer system for that and other purposes. Reliance on the QS1 computer system was reasonable and was made in good faith. The QS1 is a computer system commonly utilized by pharmacies. The system maintains inventory, patient profiles, and patient addresses and phone numbers. The QS1 system enables Rx to capture and monitor patient profiles in dispensing medications. The evidence is less than clear and convincing that the information in the patient profiles is inaccurate or inadequate. Rx employees enter a prescription into the QS1 system and then retrieve the prescribed medication from inventory. If the medication has not been pre-packed, the employee counts the medication and places it in a vial. If the medication has been pre-packed, Rx labels the medication. The QS1 system alerts Rx employees to any particular problems that a patient may have as a result of the prescribed medication. If an Rx employee receives an alert, she or he reviews the patient profile and resolves the problem. Once the prescription is prepared for dispensing, Rx pharmacists compare the prescription with the vial label to ensure accuracy. Rx employees then place the medication in an envelope for shipping but do not actually ship the medication until they receive a signed copy of the daily log from the prescribing physician verifying that the physician has not prescribed medication in excessive quantities. The daily log is not a prescription but is an extra step taken by Rx to ensure the accuracy of the order for medication. The QS1 system performed its purpose well when measured by statistical standards. There are approximately 1,942 prescriptions listed in P94. Only 24 of those were for excessive quantities of obesity drugs. The QS1 system achieved an error rate of approximately 1.23 percent. That rate of error, however, produced excessive quantities of medication almost once a day for 26 days. Rx relied on the QS1 system in filling approximately 154,773 prescriptions between October 19, 2001, and April 26, 2002. If the QS1 system were to maintain an error rate of 1.23 percent during that period, the mathematical probability is that Rx would have dispensed excessive quantities of medication in 1,903 instances over approximately 190 days for an average of approximately 10 instances a day. If the excess quantity in each instance were equal to 1,761 milligrams, according to the average determined in paragraph 76 of the Findings of Fact, Rx would have dispensed 17,644 milligrams of excess medication each day and 3,352,429 milligrams of excess medication in 190 days. An error rate of 1.23 percent represents a significant potential for harm. However, the evidence of actual harm is less than clear and convincing. Rx dispensed excessive quantities of obesity drugs in 24 instances evidenced in P94. Rx dispensed the medication irrespective of whether the patients actually received it. Receipt is a relevant inquiry to determine harm to an identified recipient. Receipt does not determine whether Rx employees dispensed obesity drugs from the pharmacy. The grounds alleged in paragraphs 15 through 17 are not disputed. Paragraph 18 alleges, in relevant part: The concept of dispensing . . . scheduled drugs by permitting them to be specifically requested and 'ordered' over the internet is a potentially dangerous method of allowing . . . medications to be 'taken on the user's own initiative rather than on the basis of professional medical advice. ' Dispensing controlled . . . drugs in this manner by Respondent[s] runs contrary to the spirit, intent, and purpose of chapter 893 with regard to protecting the safety of the public. (emphasis supplied) No findings are made concerning the grounds alleged in paragraph 18. The trier of fact cannot discern what specific acts or omissions paragraph 18 alleges. Paragraph 18 implies that Respondents somehow transformed a "concept" into a "method" but does not allege any specific acts or omissions by which Respondents effectuated the transformation. Paragraph 18 is devoid of patient names, dates, specific transactions, details, and other allegations of essential facts. Several allegations in paragraphs 19 through 21 concern the "Physician's Desk Reference" (PDR). Other than those findings already made, the trier of fact is uncertain what Petitioner intends to allege in paragraphs 19 through 21. The PDR is a method of proving a fact not alleged. Evidence of the legal effect of the PDR in this proceeding is less than clear and convincing. Petitioner failed to sufficiently evidence the specific standards allegedly enunciated in the PDR. The allegation is that the PDR states that obesity drugs should be discontinued within a "few weeks." Petitioner failed to define a "few weeks" with clear and convincing evidence as any period less than 90 days. The remaining grounds alleged in paragraphs 19 through 21 recite or paraphrase provisions of the PDR. No further findings are made concerning paragraphs 19 through 21. Petitioner proved the allegation in paragraph 22 that Rx dispensed hundreds of medications each day from October 5 through 18, 2001. Petitioner did not prove the remaining grounds alleged in paragraph 22. For reasons stated in paragraphs 9 through 11 of the Findings of Fact, evidence of the allegation in paragraph 22 that prescribing physicians wrote and submitted prescriptions based solely on information received from Internet questionnaires is less than clear and convincing. Information included in the Internet questionnaires is not established by the requisite standard of proof. No finding is made concerning the grounds alleged against Rx in paragraphs 23 through 24 or those alleged against Gordon in paragraphs 23 through 25. Petitioner concedes in its PRO at pages 27 through 28 that Petitioner did not prove grounds supporting the charges that: Respondents failed to report violators to Petitioner; and used USAP to promote or advertise the use or sale of controlled substances. Petitioner proved the grounds alleged against Rx in paragraphs 25 and 26 and those alleged against Gordon in paragraphs 26 and 27. Respondents produced the written record of prescriptions requested by the inspector. Respondents conferred with their attorney before producing the documents. The grounds alleged in paragraphs 27 through 36 against Rx and in paragraphs 28 through 37 against Gordon pertain to an inspection conducted by Petitioner on December 6, 2001. Petitioner proved some of the grounds alleged against Rx in paragraphs 27 and 28 and some of those alleged against Gordon in paragraphs 28 and 29. The evidence shows that Gordon was not present at the pharmacy during the inspection on December 6, 2001. The evidence is less than clear and convincing that Gordon worked at the pharmacy that day. The evidence is insufficient to prove that Gordon committed the acts or omissions alleged in paragraphs 28 through 31 or that the acts or omissions of others were so persistent and practiced during that period that Gordon was vicariously responsible for their acts or omissions. Petitioner proved some of the grounds alleged against Rx in paragraph 27. When the inspector first arrived, two technicians and an administrator were visible to the inspector. Two pharmacists greeted the inspector within 15 minutes of his arrival at Rx. No sign was posted that the pharmacists were out to lunch or on break. The evidence is less than clear and convincing that both pharmacists were out to lunch or on break. One of the pharmacists may have been in the bathroom or otherwise available for questions from technicians. Respondents argued during the hearing that legislation identified in the record as the "potty bill" carves out an exception to the requirement to post a sign when a pharmacist goes to the bathroom. Although the argument does not evidence the "potty bill," the argument creates sufficient doubt in the mind of the trier of fact concerning the issue of whether both pharmacists were out to lunch. Evidence of the whereabouts of the second pharmacist is less than clear and convincing. Evidence defining the term "[l]ater" is less than clear and convincing. Petitioner failed to prove the allegations in paragraph 28 that a technician was working "alone" or was "unsupervised." If it were found that Rx committed the charged violation, there would be no potential or actual harm. The requirement for a sign has little meaning for an Internet pharmacy such as Rx. The testimony of several witnesses for Petitioner makes clear that Rx is not open to patients who physically walk into the pharmacy and present written prescriptions. The front door is frequently locked. At least one investigator had to knock on the front door to gain access. Patients who fill their prescriptions at Rx "walk in" electronically and are unable to read any sign posted inside the pharmacy. The only persons who would benefit from such a sign would be those employed at the pharmacy. More likely than not, Rx employees do not need a sign to tell them a pharmacist is not in the same room with them. The evidence is less than clear and convincing that Rx employees failed to properly label drugs on December 6, 2001. The plain terms of paragraph 28 admit that Rx complied with all but one of the labeling requirements in Rule 64F-12.006(1)(a) by ensuring that its employees place pills in vials labeled with all of the requisite information except dosage form. The evidence is less than clear and convincing that the labels did not include dosage form. The evidence is less than clear and convincing that Rx placed the labeled vials with "unsigned prescriptions." Rather, the preponderance of evidence shows that the unsigned documents are the written record of electronic prescriptions and not unsigned written prescriptions. Petitioner proved the allegations against Rx in paragraph 29. The dates alleged in paragraph 29 are included in previous findings that Rx dispenses large numbers of medications ordered by Drs. Rosenkrantz, Rivera, and Thompson. Petitioner did not prove substantially similar allegations against Gordon in paragraph 30. Petitioner did not prove the allegations in paragraph 30 and 31 that Rx and Gordon knowingly possessed mislabeled drugs. The evidence is less than clear and convincing that Rx employees possessed mislabeled drugs or, if so, that Rx or Gordon are vicariously responsible for that deficiency. The grounds alleged to have occurred on December 6, 2001, are not supported by the quantum or quality of evidence that supports the finding of mislabeled drugs on October 18, 2001. Evidence of grounds arising from the inspection on December 6, 2001, primarily consists of the testimony of one inspector and three exhibits. The photographs in evidence pertain to the inspection conducted on October 18, 2001. Petitioner's experts relied on those photographs, in relevant part, in rendering their opinions concerning allegations that Rx knowingly possessed mislabeled drugs. Expert opinions are unnecessary to assist the trier of fact in determining whether Rx possessed mislabeled drugs on any date. The trier of fact is capable of making that determination based on the standards enunciated in the applicable rules, the testimony of the fact witnesses, and the pictures and documents that support their testimony. Grounds alleged against Rx in paragraphs 31-36, and those alleged against Gordon in paragraphs 32-37, arise from a re-inspection conducted on January 31, 2002. Like the evidence pertaining to the inspection on December 6, 2001, grounds arising from the inspection on January 31, 2002, are not supported by the quantum or quality of evidence that supports the inspection of October 18, 2001. Petitioner must prove the grounds arising from each inspection by clear and convincing evidence. The trier of fact cannot draw an inference from the findings pertaining to October 18, 2001, to bolster the evidence submitted for the other inspections. If it were found that evidence concerning each inspection satisfied the clear and convincing standard of proof, it would be appropriate for the trier of fact to consider all of the inspections in determining whether the alleged deficiencies were so persistent and practiced that they supported an inference of vicarious responsibility. The evidence is less than clear and convincing that the alleged grounds arising from the inspection on January 31, 2002, are true. The preponderance of evidence shows a bin containing unlabeled vials of medication was on top of a counter on one side of a room in the pharmacy. On the other side of the room, all of the medication vials and bins were labeled. The medication in the bin by itself was separated from medication in the pharmacy's active stock. Bins of medication containing active stock were labeled. It is unlikely the separated medication would be inadvertently dispensed. Medication in the separated bin was not labeled because it was being returned to the manufacturer. Respondents did not hold medication in the separated bin to be dispensed. The grounds alleged against Rx in paragraphs 37 through 65 and against Gordon in paragraphs 38 through 65 pertain to complaints filed by T.M. and J.W. For convenience, a finding pertaining to the cited paragraphs may contain references to more than one paragraph. References to a lower numbered paragraph, or group of paragraphs, refer to the grounds alleged against Rx. References to a higher numbered paragraph, or group of paragraphs, refer to grounds alleged against Gordon. Petitioner proved the grounds alleged in paragraphs 37 (against Rx) and 38 (against Gordon). Petitioner proved some of the grounds alleged in paragraphs 38 through 48 and 39 through 49 and portions of the grounds alleged against Rx in paragraph 52. On October 21, 2001, T.M. opened an e-mail from USAP and responded with information about her. T.M. purchased 90 tablets of Phentermine and paid $169 to USAP by credit card. T.M. subsequently returned the medication and received a refund. T.M. received the medication by overnight delivery. The vial label indicated Rx dispensed the medication. The label listed Dr. Rivera as the prescribing physician. T.M. never saw Dr. Rivera or heard of Rx or Gordon before receiving the medication. T.M. did not choose Rx as a pharmacy and did not choose Gordon as a pharmacist. T.M. attempted to return the medication for a refund. T.M. spoke by telephone to a representative of USAP. The representative denied T.M.'s request for refund. T.M. telephoned Rx at the number provided on the prescription label. T.M. spoke to a female who identified herself as a pharmacist and answered with a heavy accent. It is not clear that Gordon has a heavy accent. T.M. had no technical questions of the medication dispensed by Rx. The pharmacist stated that she could not help T.M. with her refund and referred T.M. back to USAP. The remaining testimony of T.M. is less than clear and convincing. On cross examination, T.M. distinctly recalled few, if any, facts. Her testimony was neither precise nor specific. T.M. was confused as to material facts in issue. Petitioner failed to prove the remaining grounds alleged in paragraphs 38 through 48 and 39 through 49. The ALJ ruled that evidence of the statements made in the USAP website is hearsay and that Sections 120.57(1)(c) and (l) prohibit the trier of fact from basing a finding on anything less than competent and substantial evidence. There is less than clear and convincing evidence that the website does not afford patients a choice in pharmacies. If it were found that the USAP website failed to offer a choice of pharmacies, the evidence is less than clear and convincing that Respondents knowingly participated in a system that does not afford a choice in pharmacies. USAP is located in the same building that Rx occupies at 5400 University Drive. Any further findings would require the fact-finder to draw an inference based on insufficient evidence. The evidence is less than clear and convincing that Rx controls the operations of USAP; that Rx and USAP are sibling or related companies, or share common officers, managers, directors, or employees; or that Rx has any legal or actual influence in the management or operation of USAP. The evidence is less than clear and convincing that Respondents had editorial control or input into the content and operation of the website used by USAP in the conduct of USAP's business; or that Respondents knew the content of the website. For similar reasons, evidence of the grounds alleged in paragraphs 53 through 65 concerning the content of the USAP website is less than clear and convincing. Petitioner failed to prove the grounds in paragraphs 43 and 44 alleging that the obesity medication prescription for T.M. was not written within the course of the professional practice of medicine. The prescriptions were not written. Petitioner failed to prove the grounds alleged in paragraphs 49 through 51 and 50 through 52. Operative terms in Section 893.02(20) apply to a pharmacist and not to a pharmacy. A pharmacist and a pharmacy are defined separately in Section 465.03(10) and (11). Section 893.02(20) does not require a pharmacy, including Rx, to make any determination regarding the validity test defined in paragraph 42 of the Findings of Fact. Section 893.02(20) requires Gordon to apply the validity test only if Gordon receives a prescription ordered by a physician licensed in a state other than Florida. While the statute necessarily requires Gordon to determine the state in which the prescribing physician is licensed before Gordon can know whether to apply the validity test, the evidence is less than clear and convincing that Gordon failed to perform her statutory duty. Petitioner did not submit any competent substantial evidence that Drs. Rosenkrantz, Rivera, and Thompson are licensed in a state other than Florida. Sufficient evidence of the statutory prerequisite to the charged violation is missing from the record. The prescriptions evidenced in P92 list a Florida address for Drs. Rosenkrantz and Rivera and a Missouri address for Dr. Thompson. It may be reasonable for the fact-finder to infer that the physicians are licensed in the state where they are located, but such an inference is less than clear and convincing. If Drs. Rosenkrantz and Rivera were licensed in Florida, Section 893.02(20) would impose no statutory duty on Gordon concerning their prescriptions. Dr. Thompson is not licensed in Florida. It is unclear that Dr. Thompson is licensed in a state other than Florida. Sufficient evidence of the statutory prerequisite to the charged violation is missing from the record. If it were found that Drs. Rosenkrantz, Rivera, and Thompson are licensed in a state other than Florida, the evidence is less than clear and convincing that Gordon failed to correctly apply the validity test prescribed in Section 893.02(20). Before employees of the pharmacy managed by Gordon dispensed any medications ordered by these physicians, the employees required each physician to sign a site fill list, or daily log, verifying the validity of the professional relationship, the authenticity of the prescription, and the medical necessity for the drugs. An unwritten agency statement prohibits Gordon from dispensing any controlled substance pursuant to a prescription transmitted by a physician who has not conducted an in-person examination of the patient. The unwritten agency statement requires Gordon to determine whether the physician has conducted an in-person examination regardless of the state in which the physician is licensed. It is clear from the record that Drs. Rosenkrantz, Rivera, and Thompson did not physically examine their patients prior to ordering the prescriptions evidenced in P92. Drs. Rosenkrantz, Rivera, and Thompson transmitted substantially all of the prescriptions evidenced in P92. The prescriptions list Florida addresses for Drs. Rosenkrantz and Rivera and a Missouri address for Dr. Thompson. The prescriptions are for patients located in more than 36 states and the District of Columbia. By negative proof, three prescribing physicians in Florida and Missouri could not have physically examined all of the patients in a single day. For purposes of continuity, further findings regarding the agency statement are made in the Conclusions of Law. Petitioner failed to prove the allegations in paragraphs 64 and 65 that Respondents engage in a fee splitting, commission, kickback, rebate, or split fee arrangement with USAP. Standards defining the prohibited arrangement are not defined clearly and convincingly. No evidence shows that Gordon receives anything from USAP or pays anything to USAP. Rx and USAP are located in the same building and maintain a business relationship. USAP pays Rx a fee for filling prescriptions plus any costs incurred by Rx. USAP pays Rx the costs of each prescription filled plus a fee of either $5 or $10 for each prescription. From October 19, 2001, through January 18, 2002, Rx filled approximately 66,217 prescriptions and billed USAP approximately $584,460 for fees, exclusive of costs. From January 25 through April 26, 2002, Rx filled approximately 88,556 prescriptions and billed USAP approximately $416,100 for fees, exclusive of costs. The evidence is less than clear and convincing that Rx paid any amount to USAP for referring patients to Rx or otherwise. The evidence is less than clear and convincing that USAP paid Rx for anything other than the costs incurred and services performed in filling prescriptions.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding Gordon not guilty of the allegations in the two administrative complaints against her; Rx guilty of violating Section 465.016(1)(i); imposing an administrative fine of $24,000 for the 24 instances of dispensing excessive quantities of controlled substances; placing Rx on probation for one year, subject to the condition that Rx utilize personal review or some other system adequate to prevent its employees from dispensing excessive quantities of controlled substances; and requiring Rx to pay the costs directly related to that part of the investigation and prosecution required to prove that Rx dispensed excessive quantities of controlled substances. DONE AND ENTERED this 10th day of January, 2003, in Tallahassee, Leon County, Florida. DANIEL MANRY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 10th day of January, 2003. COPIES FURNISHED: Rosanna M. Catalano, Esquire David Herman, Esquire John Raymaker, Esquire Bureau of Practitioner Regulation - Legal Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Sean M. Ellsworth, Esquire Mark A. Dresnick, Esquire Monica L. Felder, Esquire Dresnick, Ellsworth & Felder, P.A. 201 Alhambra Circle Sun Trust Plaza, Suite 701 Coral Gables, Florida 33134-5108 John Taylor, R.Ph., Executive Director Board of Pharmacy Department of Health 4052 Bald Cypress Way, Bin C-04 Tallahassee, Florida 32399-1701 S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701
The Issue Whether Shady Rest Care Pavilion, Inc. failed to maintain the nutritional status of one of its residents so as to justify the imposition of a conditional license rating upon the facility and an administrative fine of $2,500.
Findings Of Fact Based upon the testimony and evidence received at the hearing and the parties' stipulations, the following findings are made: Shady Rest is licensed by the Agency as a skilled nursing facility. Shady Rest's license number is SNF1497096. The Agency conducted an on-site survey of Shady Rest from July 30, 2001, to August 2, 2001. At the time of the survey, Shady Rest's licensure status was standard. The survey was conducted by a "team" that included dietitian Lori Riddle and other health care professionals. The survey team identified several deficiencies at the facility. The deficiencies were detailed on the Form 2567 which was provided to Shady Rest by the Agency. The only deficiency still at issue in this proceeding is the Tag F325 which was summarized on the Form 2567 as follows: Based on observations, clinical record review and staff interviews, the facility failed to ensure that nutritional needs were met for 3 (Residents 11, 21 and 22) of 5 active sampled residents receiving tube feeding who were at high risk for malnutrition as evidenced by significant weight loss, low albumin and total protein levels and recurring pressure sores. The survey team classified the Tag F325 at Level "G" (i.e., isolated actual harm) on the federal scope and severity matrix, which corresponds to an isolated Class II deficiency under the Florida classification scheme. Based upon the cited Class II deficiency, the Agency issued a notice of intent to change Shady Rest's licensure status from standard to conditional, and the Agency initiated a separate action to impose an administrative fine upon Shady Rest. This proceeding followed. At the hearing, the Agency narrowed the focus of the alleged deficiency from the three residents identified on the Form 2567 to only one, Resident 11. No evidence or testimony was presented regarding any other residents. Resident 11 is a female. At the time of the survey, she was 89 years old, 64 inches (five feet, four inches) tall, and weighed 145 pounds. She has been at Shady Rest since 1987. A care plan for Resident 11 was developed by a "team" that included the director of nursing at Shady Rest, a nurse (Sonja Reece, R.N.), a dietitian (Ann Marie Shields, R.D.), two care plan coordinators, and social service and activity personnel. Members of the care plan team worked closely with Resident 11's physician, Dr. Lakshmi Bushan, to manage Resident 11's medical conditions. Dr. Bushan was actively involved with the care of Resident 11 and was very familiar with her conditions. Dr. Bushan was at the facility on a weekly basis and sometimes several times per week. Resident 11 is totally dependent on Shady Rest and its staff for the provision of nutrition. She is fed through a tube connected directly to her stomach. Resident 11 is a "very complex resident" as a result of a myriad of serious medical conditions, including heart attack, seizure disorder, edema (i.e., swelling of the tissues due to fluid retention), hiatal hernia with reflux, pemphagus (i.e., an autoimmune disease resulting in blisters around the body), congestion in the lungs which caused breathing problems, kidney disease, and liver problems. She was also prone to skin breakdown. The treatment of Resident 11 was complicated by the fact that management of one of her conditions would exacerbate another. For example, the Prednisone she was taking to treat her pemphagus increased her fluid retention and, hence, her edema; but, Lasix, the diuretic she was taking for the edema, caused her to have diarrhea which led to the breakdown of her skin from constant cleaning and put her at risk of dehydration and kidney failure. Resident 11's edema was at a dangerous level, referred to as "3+ pitting edema." Relieving the edema was determined to be of critical importance to Resident 11 by her physician. The fluid retention in Resident 11's lungs caused her to suffer from shortness of breath which could ultimately lead to congestive heart failure. Because Resident 11 did not respond well to Lasix and because it actually exacerbated her other medical problems (i.e., skin breakdown), a fluid reduction diet was deemed necessary by her physician. Resident 11 was overweight, partially due to her edema. Resident 11's weight contributed to and exacerbated her medical conditions, particularly her congestion and breathing problems, and it enhanced her risk of congestive heart failure. On April 3, 2001, Dr. Bushan ordered an evaluation of Resident 11's nutritional status and the adequacy of her tube feeding. Resident 11 weighed 163 pounds on that date. On April 4, 2001, Ms. Shields, performed the evaluation ordered by Dr. Bushan. Ms. Shields calculated the total calories per day (cal/day) needed by Resident 11 based upon a standard formula. She then subtracted 400 cal/day to take into account the weight loss desired by Dr. Bushan. Ms. Shields' calculation resulted in an estimated caloric need for Resident 11 of 1,100 to 1,200 cal/day. Because the feeding ordered at that time provided 1,125 cal/day, which was within the range computed by Ms. Shields, no changes were made to Resident 11's diet at that time. Resident 11 was, however, taken off Lasix at that time because it was not contributing significantly to her weight loss and it was putting her at risk for dehydration and kidney failure. Resident 11's weight dropped only slightly after the April 4, 2001, evaluation. On May 1, 2001, she weighed 159 pounds and on June 1, 2001, she weighed 158 pounds. Dr. Bushan wanted Resident 11 to lose more weight more rapidly to stabilize her serious medical conditions. Accordingly, on June 13, 2001, Dr. Bushan requested a dietary consultant to check the amount of Resident 11's tube feedings in order to implement a planned weight loss program to reduce Resident 11's weight to 145 to 150 pounds. Ms. Shields conducted the assessment on June 14, 2001, and after consulting with Resident 11's care plan team, she recommended to Dr. Bushan that Resident 11's caloric intake be reduced from 1,125 cal/day to 750 cal/day to accomplish the rapid and significant weight loss desired by Dr. Bushan. Dr. Bushan accepted Ms. Shield's recommendations and ordered the reduction in calories on June 14, 2001. On that date, Resident 11 weighed 158 pounds. Resident 11's care plan was updated on June 14, 2001, to reflect the goal of reducing her weight by not more than five pounds per week until she reached less than or equal to 150 pounds. The dietary change achieved the desired effect of rapidly reducing Resident 11's weight and stabilizing her medical conditions. Her weight records showed the following: Date June 20, 2001 Weight 153 June 27, 2001 153 July 4, 2001 152 July 11, 2001 153 July 18, 2001 152 July 25, 2001 n/a August 2, 2001 145 The dietary notes for August 1, 2001, indicate that Resident 11's "weight goal was met" and recommended a dietary change to increase Resident 11's caloric intake to 1,000 cal/day. The record does not include the doctor's order implementing that recommendation. However, by August 8, 2001, Resident 11's weight was at 151 pounds, suggesting that the dietary change was implemented. Between the June 14, 2001, dietary change and the August 2, 2001, survey, Resident 11 lost 13 pounds, which is an 8.2 percent weight loss. For the three-month period of May 1, 2001 through August 2, 2001, Resident 11 lost 14 pounds, which is an 8.8 percent weight loss. Resident 11's edema improved significantly during this period; it was no longer at the "3+ pitting edema" level. In this regard, some of Resident 11's weight loss is attributable to the elimination of retained fluids (i.e., reduction in her edema), which was a significant purpose of the weight loss program. The amount of the weight loss attributable to the fluid loss is not quantifiable. The federal guidelines discussing Tag F325, which the Agency's survey team uses in its evaluation of a facility, state that "weight loss (or gain) is a guide in determining nutritional status" and identify parameters to be used in evaluating the significance or severity of weight loss. The 8.8 percent weight loss experienced by Resident 11 over a three- month period would be considered "severe" based upon the parameters. The parameters in the federal guidelines specifically refer to "unplanned and undesired weight loss." By contrast, the weight loss experienced by Resident 11 was planned and desirable. It was directed by Dr. Bushan after Ms. Shield's dietary consultation in order to reduce Resident 11's fluid intake and her edema while also promoting rapid weight loss to minimize her congestion and related breathing problems. The estimated protein needs for Resident 11 were 53 to 57 grams per day. The protein that she was being given, both prior to and after the June 14, 2001, dietary change was within that range. Increasing Resident 11's protein to offset the calorie reduction was not considered a viable option for Resident 11 because her history showed that the more protein she received the more weight she gained. Moreover, too much protein could cause liver failure, which was a risk for Resident 11. When the body is not receiving enough calories, it can metabolize protein as a calorie source rather than for the purposes protein is normally used, such as health of the skin. Resident 11 experienced skin breakdown (i.e., pressure sores or decubitus ulcers) after the June 14, 2001, dietary change. The sores were very small in size and, consistent with Resident 11's past history, the sores healed quickly. Therefore, they are not indicative of a protein deficiency. Indeed, subsequent to the dietary change, Resident 11's skin turgor was good. The laboratory reports for Resident 11 showed her having low albumin levels after the dietary change. Low albumin is generally an indicator of insufficient protein in the body. However, as noted above, the rate at which Resident 11's skin healed suggests that she was getting sufficient protein. Resident 11's low albumin level, in and of itself, is not determinative of her nutritional status. Indeed, the federal guidelines provided to the survey team state: Because some healthy elderly people have abnormal laboratory values, and because abnormal values can be expected in some disease processes, do not expect laboratory values to be within normal ranges for all residents. Consider abnormal values in conjunction with the resident's clinical condition and baseline abnormal values. Even before the June 14, 2001, dietary change, Resident 11's albumin level was not within the normal range. Her abnormal albumin levels may have been the result of her liver problems. Dr. Bushan and the care plan team at Shady Rest managed Resident 11's care based upon their clinical observations of her in conjunction with their experience regarding what worked for her in the past, not simply based upon her laboratory values. They were constantly weighing standards of practice with what was actually happening with Resident 11.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration issue a final order which: Dismisses the Administrative Complaint against Shady Rest Care Pavilion in DOAH Case No. 02-1291; and Rescinds the notice of intent to assign conditional licensure status to Shady Rest Care Pavilion in DOAH Case No. 02-1965 and retains the facility's standard licensure status. DONE AND ENTERED this 26th day of August, 2002, in Tallahassee, Leon County, Florida. T. KENT WETHERELL, II Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of August, 2002.
Findings Of Fact 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.
The Issue DOAH Case No. 02-0949: Whether Respondent's licensure status should be reduced from standard to conditional. DOAH Case No. 02-1299: Whether Respondent committed the violation alleged in the Administrative Complaint dated February 19, 2002, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: AHCA is the state Agency responsible for licensure and regulation of nursing homes operating in the State of Florida. Chapter 400, Part II, Florida Statutes. Harbour Health operates a licensed nursing home at 23013 Westchester Boulevard, Port Charlotte, Florida. The standard form used by AHCA to document survey findings, titled "Statement of Deficiencies and Plan of Correction," is commonly referred to as a "2567" form. The individual deficiencies are noted on the form by way of identifying numbers commonly called "Tags." A Tag identifies the applicable regulatory standard that the surveyors believe has been violated and provides a summary of the violation, specific factual allegations that the surveyors believe support the violation, and two ratings which indicate the severity of the deficiency. One of the ratings identified in a Tag is a "scope and severity" rating, which is a letter rating from A to L with A representing the least severe deficiency and L representing the most severe. The second rating is a "class" rating, which is a numerical rating of I, II, or III, with I representing the most severe deficiency and III representing the least severe deficiency. On October 22 through 25, 2001, AHCA conducted an annual licensure and certification survey of Harbour Health, to evaluate the facility's compliance with state and federal regulations governing the operation of nursing homes. The survey team alleged several deficiencies during the survey, only one of which is at issue in these proceedings. At issue is a deficiency identified as Tag F325 (violation of 42 C.F.R. Section 483.25(i)(1), relating to maintenance of acceptable parameters of nutritional status). The deficiency alleged in the survey was classified as Class II under the Florida classification system for nursing homes. A Class II deficiency is "a deficiency that the agency determines has compromised the resident's ability to maintain or reach his or her highest practicable physical, mental, and psychosocial well-being, as defined by an accurate and comprehensive resident assessment, plan of care, and provision of services." Section 400.23(8)(b), Florida Statutes. The deficiency alleged in the survey was cited at a federal scope and severity rating of G, meaning that the deficiency was isolated and caused actual harm that is not immediate jeopardy. Based on the alleged Class II deficiency in Tag F325, AHCA imposed a conditional license on Harbour Health, effective October 25, 2001. The license expiration date was August 31, 2002. The survey allegedly found a violation of 42 C.F.R. Section 483.25(i)(1), which states: Nutrition. Based on a resident's comprehensive assessment, the facility must ensure that a resident-- Maintains acceptable parameters of nutritional status, such as body weight and protein levels, unless the resident's clinical condition demonstrates that this is not possible. . . . This requirement is referenced on Form 2567 as "Tag F325." The survey found one instance in which Harbour Health allegedly failed to ensure that a resident maintained acceptable parameters of nutritional status. The surveyor's observation on Form 2567 concerned Resident 5, or "R-5": Based on observations, record review and staff interviews, the facility failed to maintain acceptable parameters of nutritional status and did not use all possible interventions, to prevent an unplanned, severe weight loss (7.8 percent in a two month period) for 1 (Resident 5) of 20 active sampled residents. The findings include: During her lunch on 10/22/01 at approximately 12:20 P.M., Resident 5 was observed clinching her teeth together making it difficult to get food into her mouth. Resident 5 was observed on 10/23/01 at 12:30 P.M., taking a limited amount of thickened liquids from her nosey cup, and clinching her teeth together making feeding her more difficult. Resident 5 was observed 5:25 P.M. until 5:55 P.M. on 10/23/01, taking small sips from the nosey cup and clinching her teeth together making it very difficult for the Certified Nursing Assistant (CNA) to feed her 25 percent of her meal. These observations were made in the assisted dining room on A-Wing. Record review of Resident 5's chart, documents 5/1/01 she weighed 127 pounds. On 7/2/01 and again on 7/16/01, her weight was documented 117 pounds. This is a severe weight loss of 7.8 percent in a two month period. Review of the resident's care plan dated 7/18/01, revealed the resident's nutrition problem was "Res. is on a puree diet with thickened liquids-- is continuing to lose weight-- is terminal-- weight is down 6 pounds for the month-- on weekly weight-- consumes 25-50 percent of her meals-- small portions at lunch-- super cereal on breakfast tray and Carnation Instant Breakfast on other trays. Resident can be combative during meals-- resists any attempt to assist her with eating-- is very difficult to feed." Approaches to address the problem included consult with Registered Dietician as needed and to monitor labs. Further review of the care plan included the problem: "Resident is on psychotropic meds for dementia with psychosis as evidenced by . . . increased agitation and resisting care." Review of the resident's physician orders reveal the resident began receiving Risperdal in July 2001 for the diagnosis of psychosis. The record also revealed that the resident was given a terminal status in January 2001. During an interview at 5:20 P.M. on 10/23/01, regarding Resident 5's evening meal being delivered after the other 3 residents at her table, the Certified Nursing Assistant stated, "She don't eat nothing anyway." Interview with CDM (Certified Dietary Manager) and Consulting Dietician on 10/23/01 at approximately 4:45 P.M., regarding resident's severe weight loss and limited nutritional intake, revealed that the Consulting Dietician stated she was unaware of this resident. The CDM stated the resident clinches her teeth, refuses food, and they have tried everything else. She stated that the resident was terminal and that the family did not want a tube feeding placed. The resident was put on thickened liquids by a speech therapist in 1998 for dysphagia, but there had been no speech therapy follow-up. They confirmed that no psychiatric consult was ordered since the care plan was developed, despite continued behaviors during feeding. An interview was conducted with the CDM joined by the DON regarding Resident 5's weight loss and possible interventions on 10/24/01 at 3:05 P.M. It was identified that no routine snacks were ordered, no psychiatric follow-up nor speech therapy follow-up, nor medication adjustments had been done during May 2001 through July 2001. The CDM stated that the facility only acknowledges a 5 percent weight loss at an interval of 1 month, and 10 percent at a 6 month interval as significant, but would not look at a 7.5 percent because it would not trigger on the Minimum Data Set. On 10/24/01 at 3:55 P.M., during an interview with the Unit Manager regarding Resident 5, she stated there was no psychiatric or mental health evaluation ordered, it was only on her care plan. Diane Ashworth was the survey team member who recorded the observation of R-5. Ms. Ashworth based her findings on her observations of R-5, a review of the resident's medical records, and interviews with Harbour Health staff. R-5 was a 92-year-old female who had resided at Harbour Health since 1998. She suffered from dementia with psychosis, in particular end-stage Alzheimer's disease. Her worsening condition caused her physician to request a neurological consultation in January 2001. The consulting neurologist diagnosed her condition as terminal. R-5 was severely impaired cognitively, and was completely dependent on Harbor Health staff for all of her care. R-5 was unable to feed herself. For over three years, Harbour Health has implemented a "restorative dining" program for residents with eating problems. In the restorative dining program, the resident is taken to a quiet area and given one-to-one attention by a CNA during meals. R-5 has been in the restorative dining program since its introduction. During her entire stay at Harbour Health, R-5 was very difficult to feed. She would clench her teeth, cover her mouth and push away. At times she would take the food into her mouth, then spit it back into the face of the caregiver. R-5's medical condition made it impossible to reason with her about the importance of maintaining nutrition. The CNA assigned to R-5 as her restorative aide would spend up to two hours feeding one meal to her. The CNA would attempt to feed R-5 until her agitation and resistance made it impossible. The CNA would refrigerate the food, then wait for R-5 to calm down. Then the CNA would reheat the food and begin the process again. Because of her Alzheimer's and her difficult behavior during meals, R-5 was identified as at risk for weight loss and dehydration. Harbour Health's care plan for R-5 identified several strategies for maximizing R-5's caloric intake, and called for consultation with the facility's registered dietician when needed. R-5 was on a no-sodium-added puree diet, taking thickened liquids in place of solid food. Because she tended to consume only 25 to 50 percent of the food offered at meals, the facility offered her 3,252 calories per day at meals, well in excess of the 1,677 to 1,960 calories required to maintain her usual body weight of 120 to 123 pounds. Staff noted that R-5 appeared overwhelmed by large portions of food and began offering her smaller amounts at one time. R-5 was offered fortified cereals and potatoes, and supplements such as Health Shake and Carnation Instant Breakfast. If R-5 showed signs of accepting certain foods, such as eggs, staff would order extra portions of those foods. Snacks were offered between meals, and R-5 was given vitamin C, zinc, and multivitamins with iron to supplement her nutrition. Staff employed items such as a "Nosey Cup," a cup designed to permit its being held near the resident's face without bumping the nose, to ease the feeding process. Harbour Health's standard practice was to weigh residents once per month. If the monthly weights indicated a problem, then Harbour Health would commence weighing the resident on a weekly basis until the problem was resolved. As noted by Ms. Ashworth, R-5 weighed 127 pounds at her monthly weighing on May 1, 2001. At her next monthly weighing on June 1, 2001, R-5 weighed 123 pounds. At the following monthly weighing on July 2, 2001, R-5 weighed 117 pounds. Ms. Ashworth calculated the weight loss from May 1 to July 2, 2001 as 7.8 percent of R-5's body weight. Noting the weight loss, Harbour Health placed R-5 on weekly weights in July 2001. On July 16, 2001, her weight remained at 117 pounds. On July 23, 2001, her weight had increased to 123 pounds. On August 1, 2001, R-5's weight was 125 pounds. Thus, by early August R-5 had regained nearly all of the weight she had lost between May and July 2001. On July 6, 2001, R-5's attending physician prescribed Risperdal, an antipsychotic medication, to calm her severe agitation and constant movement. Risperdal can act as an appetite stimulant. The administration of Risperdal to R-5 coincided with her weight gain in July 2001. When the facility became aware of R-5's weight loss in July 2001, staff began offering R-5 food more often, including more snacks between meals. The attending physician removed the sodium restriction from R-5's puree diet. Aside from those steps, Harbour Health maintained the same nutritional procedures for R-5. The agency alleged that Harbour Health was deficient in not involving the consulting dietician when it became aware of R-5's weight loss. The agency further alleged that Harbour Health should have ordered a psychiatric consultation and a speech therapy consultation. Regular snacks should have been ordered, and R-5's medications should have been adjusted. Harbour Health contended that it was already doing everything possible to ensure R-5's nutritional status. The only alternative to the puree diet would be tube feeding. R-5's son, who acted as her guardian, made it clear to the facility that he would not consent to tube feeding. In May 2001, R-5 suffered from an upper respiratory infection diagnosed as bronchitis by her attending physician. On May 14, 2001, the physician ordered the antibiotic Levaquin; nebulizer treatments with Albuterol and Atrovent, both bronchodilators; and oral administration of Robitussin. All of these medications were ordered and administered for a period of one week. Harbour Health contended that R-5's respiratory infection completely explained her weight loss. The evidence does not entirely support that contention. The medical records indicate that R-5's condition was largely resolved by the latter part of May 2001. R-5 lost four pounds during the month of May 2001. The majority of R-5's weight loss occurred during the month of June 2001, after her bronchitis was treated and apparently resolved. At most, R-5's weight loss was only partially explained by her upper respiratory infection. Dr. Michael Brinson, R-5's attending physician, testified that it is expected that an end-stage Alzheimer's patient will lose weight, because at some point the resident loses the will to live. In Dr. Brinson's opinion, R-5 had reached this point, which explained her refusal to eat. He was aware of R-5's weight loss. Given R-5's clinical condition, the weight loss did not concern Dr. Brinson, who deemed it irrelevant to her care and treatment. Even Ms. Ashworth, the agency RN who performed the survey observation of R-5, agreed that weight loss can be a symptom of end-stage Alzheimer's. R-5 had been provided with a speech consultation and speech therapy in 1998. She was discharged from speech therapy in March 1998 because it was determined that nothing more could be done for her. Dr. Brinson testified that a speech therapy consultation would have been useless in July 2001. Speech therapy is called for if the resident's refusal to eat is related to a swallowing problem. R-5 had no swallowing problem. Catherine Rolin, the restorative nurse who supervised R-5's feedings, confirmed that there were no indications R-5 had difficulty swallowing, or had choked or aspirated during the time she was losing weight. Dr. Brinson opined that R-5's terminal diagnosis with end-stage Alzheimer's disease made a psychiatric consultation of no value. R-5's cognitive impairment would have rendered her unable to participate in any psychiatric examination. Dr. Brinson came to the facility at least once a week. His Advanced Registered Nurse Practitioner ("ARNP"), Vickie Swank, came to the facility several times a week. Dr. Brinson would have had to order any psychiatric or speech therapy consultation, or any laboratory work. Dr. Brinson believed that none of these was appropriate for R-5. The interdisciplinary team overseeing R-5's care included the facility's certified dietary manager. The team was aware of R-5's weight loss as of July 2, 2001, and decided that R-5's status did not trigger a need to consult the registered dietician. Deborah Blackburn, a dietician and expert in nutrition, reviewed R-5's records and concluded that there was no need to consult a registered dietician. Ms. Blackburn opined that the facility was taking all reasonable steps to maintain R- 5's caloric intake and nutritional status. She could not think of a workable approach that Harbour Health had failed to employ. Aside from the weight loss itself, R-5 suffered no skin breakdown or other negative effects. Viewing the evidence in its entirety, it is found that AHCA failed to prove the elements of Tag F325 by a preponderance of the evidence. R-5 lost the weight then quickly gained most of it back with no dramatic changes in Harbour Health's approaches to her feeding and overall nutrition. This fact demonstrates that R-5's weight loss was caused not by Harbour Health's failure to provide adequate nutrition, but by a combination of R-5's terminal Alzheimer's disease and her upper respiratory infection. Once Harbour Health became aware of the weight loss, it reacted appropriately and successfully. The steps that the agency faulted Harbour Health for failing to take--psychiatric consultation, speech therapy consultation, dietician consultation, and medication adjustments--were demonstrated to be unnecessary in light of R-5's condition.
Recommendation Upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Agency for Health Care Administration enter a final order dismissing the Administrative Complaint in DOAH Case No. 02-1299, and rescinding the notice of intent to assign conditional licensure status to Harbour Health Center in DOAH Case No. 02-0949 and reinstating the facility's standard licensure status. DONE AND ENTERED this 23rd day of September, 2002, in Tallahassee, Leon County, Florida. LAWRENCE P. STEVENSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 23rd day of September, 2002. COPIES FURNISHED: Ursula Eikman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Dennis L. Godfrey, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Room 310L St. Petersburg, Florida 33701 Karen L. Goldsmith, Esquire Goldsmith, Grout & Lewis, P.A. 2180 North Park Avenue, Suite 100 Post Office Box 2011 Winter Park, Florida 32790-2011 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valinda Clark Christian, Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
Findings Of Fact At all times material, Respondent, Michael J. Warhola, D.O. (Warhola), was licensed as an osteopathic physician, license number 05 0001256, issued by the State of Florida. At all times material, Warhola was in general practice in Tampa, Florida. A large part of Respondent's practice consisted of patients wishing to lose or control weight. PATIENT CURTIS HANCOCK Between on or about September 25, 1984 and on or about June 10, 1985, Respondent treated patient Curtis Hancock for weight control primarily. On the first visit, a patient history was obtained from Hancock. The patient history was adequate for a weight control patient such as Hancock except that it did not include a detailed record as to the length of time Hancock has experienced the weight problem, what diet medications Hancock had taken, what kind of weight loss program Hancock had been involved in and the history of recent weight loss or gain and diet. On Hancock's first visit, Warhola also had Hancock's blood pressure, weight and pulse taken. Additionally, Hancock's age and height were recorded. Respondent did not listen to (auscultate) Hancock's heart sounds but did, and reviewed, an electrocardiogram. These physical examinations and other testing performed on Hancock on the first visit were inadequate for a patient such as Hancock only in that Warhola did not examine and palpate Hancock's neck (for thyroid abnormalities). One of the tests Warhola had performed on Hancock on September 25, 1984, was a SMAC 26 comprehensive blood test which includes T3, T4 and T7 studies. Those test results and the rest of the examination revealed no abnormalities in Hancock's thyroid function or metabolic function. On or about the first office visit, Respondent provided Hancock with literature about diet. The literature contained a recommendation that the patient abstain from alcohol and sugar intake. But Respondent did not attempt to treat Hancock by diet and exercise alone first. Respondent generally makes the presumption that by the time a patient comes to him for weight control the patient has tried an assortment of diet regimens, possibly supplemented by exercise and over-the-counter diet medications. He presumes that what the patient wants and needs in order to accomplish weight loss or weight control is prescription diet drugs. On the first visit on September 25, 1984, Warhola prescribed and dispensed to Hancock the following drugs: DRUG QUANTITY Multi Vitamin 28 Phentermine 8 mg. 56 Phendimetrazine 35 mg. 56 Promethazine HCL 12.5 mg. 28 On each subsequent office visit Warhola had his office staff take Hancock's blood pressure, weight and pulse rate. At no time during his treatment of Hancock did Respondent listen to Hancock's heart sounds. No additional electrocardiograms of Hancock were taken after the initial visit. Respondent performed no other physical examination of Hancock on any of the subsequent office visits. Between October 23, 1984 and June 10, 1985, Respondent prescribed and dispensed for Hancock the following drugs: DATE MEDICATION QUANTITY 10/23/84 Multi Vitamin 28 Thyroid 1 gr. 28 Ferrous Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Prcmetharine HCL 12.5 mg. 28 11/20/84 Multi Vitamin 28 Thyroid 1 gr. 28 Ferrous Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Phentermine 8 mg. 112 Promethazine HCL 12.5 mg. 28 12/11/84 Thyroid 1 gr. 28 Ferrcus Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Promethazine HCL 12.5 Bran Fiber mg. 28 01/24/85 Multi Vitamin 28 Levo Thyroid 0.1 mg. 28 Ferrcus Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Promethazine HCL 12.5 mg. 28 Fastamine 112 02/01/85 Multi Vitamin 28 Levo Thyroid 0.1 mg. 28 Ferrous Gluconate 28 Phentermine 30 mg. 112 Phendimetrazine 35 mg. 112 Promethazine HCL 12.5 mg. 28 Fastamine 112 Vistaril 50 mg. 28 03/14/85 Multi Vitamin 56 Levo Thyroid 0.1 mg. 56 Ferrous Gluconate 56 Phentermine 30 mg. 224 Phendimetrazine 35 mg. 224 Promethazine HCL 12.5 mg. 56 Vistaril 50 mg. 56 Hyosophen - 224 (Belladonna Alkaloids w/ Phenobarbital) Hydrochlorothiazide 50 mg. 56 w/Reserpine 0.25 mg. 04/30/85 Multi Vitamin 56 Levo Thyroid 0.1 mg. 56 Ferrous Gluconate 56 Phentermine 30 mg. 224 Phendimetrazine 35 mg. 224 Promethazine HCL 12.5 mg. 56 Vistaril 50 mg. 56 Hyosophen 224 (Belladonna Alkaloids w/ Phenobarbital) Hydrochlorothiazide 50 mg. 56 w/ Reserpine 0.25 mg. 06/10/85 Multi Vitamin 56 Levo Thyroid 0.1 mg. 56 Ferrous Gluconate 56 Phentermine 30 mg. 224 Phendimetrazine 35 mg. 224 Promethazine HCL 12.5 mg. 56 Vistaril 50 mg. 56 Hyosophen 224 (Belladonna Alkaloids w/ Phenobarbital) Hydrochlorothiazide 50 mg. 56 w/ Reserpine 0.25 mg. The labels for the drugs identified in the immediately preceding paragraph did not contain the name of the drugs dispensed. Hancock did not ask, and Respondent did not verbally advise Hancock of, the names of the drugs which Respondent dispensed or caused to be dispensed to Hancock. Phentermine 8 mg. and 30 mg. and phendimetrazine 35 mg. are sympathomimetic amines. Phendimetrazine is a schedule III controlled substance, under Section 893.03, Florida Statutes. Phentermine is a schedule IV controlled substance, under Section 893.03, Florida Statutes. Tolerance to the anorectic affects of both of these drugs usually develops within a few weeks. When this occurs, the recommended dose usually should not be exceeded in an attempt to increase the effect; rather, the drugs should be discontinued. One of the notable contra-indications of both of these drugs is elevated blood pressure (moderate and severe hypertension, any diastolic value of 100 or higher). Manifestations of chronic intoxication with anorectic drugs (like phentermine and phendimetrazine) include marked insomnia, irritability, hyperactivity and personality changes. Promethazine HCL is a sleep medication. Thyroid and Levo Thyroid are both thyroid medications which are indicated for use where hypothyroidism exists. Both drugs are metabolic stimulants given to compensate for decreased thyroid function. If either of these medications is administered to an individual who had a normal thyroid function or euthyroidism, the drugs would cause the individual to experience hyperthyroidism, or an increased metabolic condition, and the possibility of serious side effects. Fastamine is the brand name for a drug containing benzocaine and is used to curb appetite by numbing the stomach. Vistaril is a depressant which can function as an anti-anxiety agent. Hydrochlorothiazide 50 mg. is a diuretic which was dispensed by Respondent in a compound form which also contained Reserpine 0.25 mg. Reserpine is a drug that will cause an initial stimulation, like epinephrine, followed by a secondary effect of depression. Hydrocholorthiazide 50 mg. with reserpine 0.25 mg. is used as a diuretic and an anti-hypertensive agent. It is generally accepted that thyroid medications, such as Thyroid, Levo Thyroid and a drug named Cytomel (which is similar in action to the other thyroid medications), should not be prescribed, dispensed, or ordered with sympathomimetic amines. The combination of thyroid medications and sympathomimetic amines, when dispensed or prescribed to be taken together, can be very dangerous and can potentially result in cardiovascular shock. Unless caused by hypothyroidism, obesity is not an acceptable indication for thyroid hormone therapy. A review of Respondent's records for patient Hancock reveals that between September 25 and December 11, 1984, Hancock lost 12 1/2 pounds. Between January 24 and February 1, 1985, Hancock gained 4 1/2 pounds. Between February 1 and April 30, 1985, Hancock lost 11 1/2 pounds. Between April 30 and June 10, 1985, Hancock gained 6 1/2 pounds. Respondent's records reflect Hancock's starting weight was 213 1/2 pounds. On the date of Hancock's last visit, almost ten months after the patient's first visit, Hancock weighed 200 1/2 pounds with a total weight loss of only 13 pounds. A review of Respondent's records for patient Hancock reveals that Hancock's blood pressure was 120/84 on September 25, 1984; 120/84 on October 23, 1984; 122/80 on November 20, 1984; 120/84 on December 11, 1984; 130/90 on January 24, 1985; 140/100 on February 21, 1985; 150/100 on March 14, 1985; 144/90 on April 30, 1985; and 130/80 on June 10', 1985. In an otherwise healthy adult, any diastolic (the second of the two numbers in a blood pressure reading) value of 90 or greater for an extended period of time is considered mild hypertension. A diastolic value of 100 or greater is considered serious hypertension. Despite the fact that the diastolic value of Hancock's blood pressure readings was 90 or higher between January 24, 1985 and April 30, 1985, Respondent did not reduce or eliminate the number of sympathomimetic amines and thyroid medications dispensed to patient Hancock. Respondent responded to the elevated blood pressure readings found in Hancock by adding an anti-hypertensive agent to the existing regimen of drugs. He hypothesized that the elevated blood pressure was a result of marital problems Hancock told him he was having. On March 14, 1985, April 30, 1985, and June 10, 1985, Respondent dispensed what was supposed to be a two months supply of the above-listed drugs. On April 30, 1985, Hancock returned for more medications after 46 days; and on June 10, 1985, Hancock returned for medications after only 40 days. Nonetheless, Respondent dispensed more medications on each occasion. Respondent's records indicate that on April 30, 1985, a two month supply was dispensed because the Respondent was going on vacation. Respondent told Ms. Gazverde during the course of an interview that if a patient returned earlier than scheduled, refills would be refused until the scheduled visit or proof of loss of medication was provided. But, if this was Respondent's policy, it was not followed in Hancock's case. Respondent inappropriately and excessively dispensed phentermine, phendimetrazine and thyroid medications, including Thyroid and Levo Thyroid, to patient Hancock in that: The phentermine and phendimetrazine were prescribed and dispensed in excessive dosages and for an excessive length of time; The phentermine and phendimetrazine were prescribed and dispensed in combination (and in excessive dosages); Thyroid medications were prescribed although Hancock's thyroid was normal; Thyroid medications were prescribed to be taken in combination with the phentermine and phendimetrazine; Respondent continued to prescribe phentermine, phendimetrozi and thyroid medications to Hancock despite moderate to severe hypertension (140/100 on 2/21/85 and 150/100 on 3/14/85); Respondent twice dispensed more drugs than he had prescribed for Hancock without requiring Hancock to account for the missing drugs; and Respondent made no effort to treat Hancock without drugs as first line of treatment. Respondent failed to practice osteopathic medicine with acceptable levels of care, skill and treatment for the reasons listed in paragraph 23, above, and because Respondent did not examine or palpate Hancock's neck for thyroid abnormalities on any visit and neither did an electrocardiogram nor listened to Hancock's heart sounds on follow-up visits. In addition to the matters set out in the two immediately preceding paragraphs, Respondent's records for patient Hancock were not adequate to justify Respondent's treatment of Hancock in that no information was recorded as to the length of time the patient had experienced a weight problem; what diet medications Hancock had taken; what kind of weight loss program Hancock had been involved in; and a history of recent weight loss or gain and diet. A reasonably prudent osteopathic physician, in obtaining a patient history for weight control purposes, would question the patient as to their normal weight, determine past techniques utilized for weight control (including medication, diet and exercise), and ascertain recent weight history and length of time the weight problem has existed. The information should be in the patient record. Additionally, a reasonably prudent physician, in examining a patient for weight control purposes, would perform a physical examination including, at a minimum, examination and palpation of the neck and auscultation of the heart. Alternatively, an electrocardiogram serves the purpose of auscultation of the heart. Respondent did not examine or palpate patient Hancock's neck. Furthermore, Respondent did not listen to patient Hancock's heart sounds. Respondent did and reviewed an electrocardiogram on Hancock's first visit but not on his follow-up visits. PATIENT HOPE ECHEZABAL Between on or about November 3, 1971 and April 21, 1984, Warhola intermittently treated patient Hope Echezabal for weight control. On Echezabal's first visit, Warhola took an adequate patient history of Echezabal except, like Hancock, the patient history does not record detailed information as to the length of time the patient had experienced a weight problem, what diet medications Echezabal had taken, what kind of weight loss program Echezabal had been involved in, or a history of recent weight loss or gain and diet. The patient history indicated normal menstruation. On Echezabal's first visit to Respondent's office, Respondent performed an inadequate physical examination only in that no pulse rate was taken and Warhola did not examine or palpate the patient's neck. Respondent also did not listen to Echezabal's heart sounds, but Warhola did have an electrocardiogram done on Echezabal. The testing did include testing with an achilleometer, an obsolete thyroid test. All of the testing and physical examination of Echezabal revealed no thyroid or metabolic abnormalities. Like Hancock after her, Echezabal was given diet literature, including a booklet called "Lo-Carbo Diet," and was advised to avoid starches, sugar, and alcoholic beverages. Respondent also discussed Echezabal's diet and eating habits. Echezabal returned to Respondent's office on December 3, 1971, January 12, 1972 and April 7, 1972. As was his practice on follow-up visits, Warhola had his office staff weigh Echezabal and take her blood pressure. Although no additional electrocardiogram was performed, Warhola did not take Echezabal's pulse rate or listen to her heart sounds. In fact, he did no further physical examination of Echezabal at all. He just discussed diet and whether Echezabal was following her diet. After a hiatus of two years, Echezabal went back to Respondent on or about August 20, 1973. In accordance with his practice, Warhola treated Echezabal as he would a new patient since she had not been to his office for over a year. Warhola had Echezabal update her patient history in the same manner in which he did her original patient history. His physical examination and testing also was the same as on the initial visit in 1971. Once again, the examination and testing revealed no thyroid or metabolic abnormalities. Warhola also discussed with the patient her diet and eating habits. Echezabal returned to Respondent's office on November 16, 1973. On this follow-up visit, Warhola had his office staff take Echezabal's blood pressure and weigh her. Otherwise, Warhola did not physically examine Echezabal. Her pulse rate was not taken, there was no additional electrocardiogram, and Respondent did not listen to her heart. Warhola did, however, again discuss Echezabal's diet and eating habits. It is clear from Echezabal's testimony that Respondent's treatment of her before May, 1979, included the use of medications. Echezabal did not ask, and was never advised either verbally or by labeling, of the names of the drugs which were dispensed to her by Respondent. As with all his patients, Respondent documented the drugs dispensed to Echezabal by utilizing medication codes instead of the common name for the drugs. The medication codes were then recorded in the patient charts. Because the medication codes have changed over the years, the identities of the drugs dispensed to Echezabal before May, 1979, are unknown. Echezabal did not return to Respondent's office again until May 29, 1979. Because it had been about 5 1/2 years since Echezabal's last visit, Respondent treated her as a new patient, requiring the same updates to her patient history and having the same examinations and tests performed, including an electrocardiogram. Testing indicated that Echezabal was marginally anemic, and Respondent prescribed and dispensed iron tablets only and told her to return for a follow-up visit. Otherwise, the examination and testing revealed no abnormalities. Echezabal returned for a follow-up visit on June 11, 1979. On that date, Warhola had his office staff take Echezabal's blood pressure and weigh her. Additionally, office staff obtained a hemoglobin and hematocrit count on Echezabal and drew blood for analysis at an outside laboratory. Warhola did not take Echezabal's pulse rate or do another electrocardiogram or listen to her heart sounds. Warhola did no other physical examination of Respondent on June 11, 1979, but only discussed diet and eating habits. On or about June 11, 1979, Respondent dispensed to Echezabal 28 ferrous sulfate 5 gr. tablets, 28 Thyroid 2 gr. tablets, 112 phendimetrazine 35 mg. tablets, 28 Benadryl 50 mg. tablets, and 28 multi vitamin/mineral tablets, with instructions to begin taking the pills on the next day. When Respondent dispensed the above-mentioned drugs on June 11, 1979, Respondent did not have the results of tests which were to be performed by an outside laboratory on blood drawn by office staff. (Respondent had ordered a SMA 15 profile, which includes testing for glucose levels, and a thyroid study done on the blood specimen.) However, Respondent would have contacted patient Echezabal when the results came back the next day if he thought the results contra-indicated any of the medications. On or about June 12, 1979, Respondent received the results of a thyroid study and SMA 15 profile at Patterson Coleman Laboratories. The tests revealed no metabolic abnormalities. The test did reveal a slight abnormality in the T3 value, which was "34". The T3 value measures thyroid uptake and was only marginally below normal limits. In determining whether there is abnormal thyroid function, the "T3" value is only one factor to be considered. In view of the fact that the two other pertinent values, the thyroxine, or T4 value, and the "FTI" value were within normal limits, Echezabal could not properly have been diagnosed as suffering from abnormal thyroid function. Furthermore, it would be inappropriate to prescribe thyroid medication, given the results of the thyroid study done in June 1979. Respondent's records for Echezabal do not document any history of an abnormal thyroid function or any history involving thyroid medications taken by Echezabal prior to 1971. Despite the fact that patient Echezabal revealed no conclusive evidence of an abnormal thyroid function, Respondent failed to discontinue the thyroid medication which he ordered for Echezabal on June 11, 1979. On or about August 2, 1983, Echezabal returned to Respondent's office and was, again, treated like a new patient. Accordingly, Echezabal was asked to update her patient history. Additionally, office staff took Echezabal's blood pressure and pulse, and weighed Echezabal. This was the first occasion on which Echezabal's pulse rate was taken. On August 2, 1983, office staff obtained a hemoglobin and hematocrit count, performed a urinalysis and performed an electrocardiogram on Echezabal. Additionally, office staff drew blood for analysis by an outside laboratory. Finally, Warhola again discussed diet and eating habits with Echezabal. On or about August 2, 1983, Respondent dispensed or caused office staff to dispense to Hope Echezabal Cytomel 50 mg. (which is a thyroid medication similar to Thyroid and Levo Thyroid discussed above), phendimetrazine 35 mg., ferrous sulfate 5 gr. (iron), and Benadryl 50 mg., an antihistamine. Again, Respondent dispensed these medications without waiting for the results of SMA 26 profile which was to be performed on the blood specimen drawn by office staff at outside laboratories. On or about August 3, 1983, Respondent received the results of the SMA 26 which was performed at Central Medical Laboratory, Inc., which included an analysis of thyroid function. The tests revealed completely normal thyroid function. Despite evidence of normal thyroid function, Respondent failed to discontinue the Cytomel 50 mg. which he had prescribed for Echezabal. On or about September 8, 1983, Echezabal returned to Respondent's office. On that date, office staff took Echezabal's blood pressure and pulse. Additionally, office staff weighed Echezabal. Finally, as was his practice, Respondent spoke to Echezabal about her diet and eating habits. Respondent failed to conduct any kind of examination of Echezabal on September 8, 1983. Nor did Warhola do another electrocardiogram. On or about September 8, 1983, Respondent caused office staff to dispense 28 Cytomel 50 mg. tablets, 112 phendimetrazine 35 mg. tablets, 28 Benadryl 50 mg. tablets and 28 multi vitamin/mineral tablets to patient Echezabal. At the time Respondent caused these medications to be dispensed, his records reflected normal thyroid function in Echezabal. On or about April 21, 1984, Echezabal again came to Respondent's office for weight control purposes. On that date, office staff obtained an update in patient history, and obtained the patient's blood pressure, pulse, and weight. Also on that date, office staff obtained hematocrit and hemoglobin levels for the patient, a two hour post prandial blood sugar, and a urinalysis. Echezabal's blood pressure was 130/90 on April 21, 1984. Respondent spoke with Echezabal about her diet and eating habits. Respondent did not examine patient Echezabal at all on April 21, 1984. Nor did Warhola do another electrocardiogram. On or about April 21, 1984, Respondent caused office staff to dispense 28 Hydroreserpine .25 mg. tablets, 28 Levo Thyroid .1 mg. tablets, 56 phentermine 30 mg. tablets, 28 Benadryl 50 mg. tablets, and 28 multi vitamin/mineral tablets to Echezabal with instructions to start taking the pills the next day. At the time Respondent dispensed the above-mentioned drugs, his own records for patient Echezabal revealed normal thyroid function. Hydroreserpine is the brand name for a compound containing a diuretic and reserpine (which has previously been described above). Hydroreserpine is typically given as an anit-hypertensive agent. On or about April 22, 1984, Echezabal began to take the medications dispensed by Respondent on April 21, 1984, in the manner directed by Respondent. Accordingly, Echezabal would have taken 4 tablets by noon on that date. Echezabal should have taken by 10:00 a.m., on April 22, 1984, a green Hydroreserpine .25 mg. tablet (probably before breakfast), a yellow phentermine 30 mg. tablet (probably before breakfast), a yellow Levo Thyroid .1 mg. tablet (probably at 10:00 a.m.) and a white phentermine 30 mg. tablet (at 10:00 am.). After taking her 10:00 a.m. medication, Echezabal experienced a reaction to the medication. Specifically, Echezabal vomited and was hyperventilating. Echezabal rested for a period of time and was later transported to University Community Hospital in Tampa, Florida, by ambulance, where she was treated for a drug overdose. At no time during his treatment of patient Echezabal did Echezabal ask, or did Respondent advise Echezabal of, the names of the drugs which were dispensed by his office staff to Echezabal. Furthermore, the labeling for the substances dispensed to Echezabal did not contain the name of the medications dispensed. When Echezabal arrived at University Community Hospital, neither Echezabal nor her husband, Henry, who drove her to the hospital, knew what drugs Mrs. Echezabal had taken on the morning of April 22, 1984. At the time of admission at University Community Hospital, blood and urine specimens were taken from Echezabal for analysis. A comprehensive drug profile showed no alcohol. A second test performed on gastric blood serum revealed ethanol in the blood serum in the amount of 0.016 GM percent. The amount would be relatively negligible. Respondent inappropriately dispensed medications to patient Echezabal in that: Thyroid medications were prescribed although Echezabal's thyroid was normal; Sympathomimetic amine was prescribed to be taken in combination with thyroid medication; Phentermine was prescribed on April 21, 1984, in excess of maximum dosages; and Respondent made no effort to treat Echezabal without drugs as a first line of treatment (especially when she lost a pound between May 28 and June 11, 1979, without any medication prescription.) Respondent failed to practice osteopathic medicine with acceptable levels of care, skill and treatment for the reasons listed in paragraph 55, above, and because Respondent did not examine or palpate Echezabal's neck for thyroid abnormalities on any visit, neither did an electrocardiogram nor listened to her heart sounds on follow-up visits or on April 21, 1984, and did not take her pulse on some visits. In addition to the matters set out in paragraphs 55 and 56, above, Respondent's records for patient Echezabal were not adequate to justify Respondent's treatment in that: The records do not detail weight control programs the patient had tried, diet medications taken or recent history of weight loss or gain and diet; The records do not justify starting Echezabal at relatively high dosages of phendimetrazine on June 11, 1979 and August 2, 1983; The records do not justify the Benadryl prescriptions; and; The records do not state whether the patient was on a diet or explain why she lost a pound between May 28 and June 11, 1979, without any medication prescription. PATIENT BETH HELLE Between on or about November 8, 1971, and on or about May 4, 1984, Respondent intermittently treated Beth Helle for weight control. On Helle's first visit, Warhola required a patient history which was adequate except it but did not detail the length of time the patient had experienced a weight problem, what diet medications she had taken, what kind of weight loss program she had been involved in or a history of the recent weight loss or gain and diet. It indicated a normal menstrual history. Warhola also performed an inadequate physical examination only in that Warhola did not take Helle's pulse or examine or palpate her neck for thyroid abnormality. He did not listen to her heart sounds, but he took Helle's cardiogram. Warhola also discussed diet with Helle. He told her what foods she could eat and gave her a book dealing with carbohydrate counts in different foods designed to assist the patient in limiting carbohydrate intake. The examination and testing of Helle on November 8, 1971, which included testing with an achilleometer, did not reveal any abnormal thyroid or metabolic function. Helle's patient history revealed hypertension in 1970, but that condition probably related to a pregnancy and miscarriage at that time. On or about November 8, 1971, Respondent caused office staff to dispense medications to Helle. Helle never asked, and Respondent never told Helle, what the medication were. The labels on medication dispensed to Helle (like Echezabal) did not contain the common name of the drug dispensed. In Respondent's records, the medication names are indicated in a code, which has since changed. The names of the medications dispensed by Respondent to Helle before 1984 are unknown. On or about May 12, 1975, Helle returned to Respondent's office for treatment. Since 3 1/2 years had passed, Helle was treated as a new patient. Helle's patient history was updated in the same manner as the original patient history. Again Warhola inadequately examined Helle only in that Helle's pulse rate was not taken, and Respondent did not examine and palpate Helle's neck. Warhola did not listen to her heart sounds, but he did perform an electrocardiogram of Helle among the tests he performed. Again, the examination and tests, which included testing with an achilleometer, revealed no abnormal thyroid or metabolic function. In addition to the examination and testing on May 12, 1975, Warhola again discussed diet with Helle. He had his office staff dispense medications to Helle. Helle did not ask, and Respondent did not verbally advise Helle of, the names of the drugs dispensed. Again, the labels were in code, and identities of the drugs are not now known. On or about June 16, 1975, Helle returned to Respondent's office. On this follow-up visit, Warhola had his office staff take and record Helle's blood pressure and weight. Her pulse was not taken, and no electrocardiogram was made. Warhola did not physically examine Helle and specifically did not listen to her heart sounds or examine or palpate her neck. Warhola again discussed eating habits and diet with Helle and had his office staff dispense medications. Again, Helle did not ask, and was not told, what the medications were, and the medication labeling did not reflect the drug name. The code on the label has been changed, and the identities of the drugs are not now known. Helle returned for another follow-up visit on October 30, 1975. Again, Warhola had his office staff take and record Helle's blood pressure and weight. Her pulse rate was not taken, and no electrocardiogram was made. Warhola did no physical examination and specifically did not listen to Helle's heart sounds or examine or palpate her neck. Respondent again discussed diet and eating habits with Helle. Helle did not return to Warhola's office for treatment until May 4, 1984. Since eight and 1/2 years had elapsed since her last visit, Helle was treated as a new patient the same type of update of her patient history was taken. Warhola also had his office staff take and record Helle's blood pressure, pulse and weight. Blood specimens for analysis at an outside laboratory also were drawn. Warhola did not listen to Helle's heart sounds but did make and review an electrocardiogram. He did not examine or palpate her neck. Finally, Respondent talked with Helle about her diet and eating habits, specifically advising her to avoid fatty foods. On or about May 4, 1984, Respondent caused office staff to dispense 28 trichloromethiazide 4-mg. tablets, 28 Levo Thyroid .1 mg. tablets, 112 phendimetrazine 35 mg. tablets, 112 phentermine 8 mg. tablets, 28 branfiber tablets, and 28 Benadryl 50 mg. tablets. Respondent dispensed these medications without waiting for the analysis by the outside laboratory of blood drawn from Helle on that date. Trichloromethiazide is an oral diuretic and anti- hypertensive agent. On or about May 5, 1984, Respondent received the results of a SMA 26 profile run on the blood specimen obtained from Helle on May 4, 1984. The laboratory results revealed normal thyroid function, normal glucose levels and normal metabolic function. On or about May 8, 1984, Respondent received the results of a TSH profile run on May 4, 1984. The test again revealed normal thyroid function. Respondent's records for patient Helle do not reveal any documentation of a history of abnormal thyroid function even though Helle testified at the formal hearing that she had experienced abnormal thyroid function previously. Proper documentation would include a description of the abnormality (hypothyroidism or hyperthyroidism); a statement as to how long the condition existed; and a description of how the condition was treated. This last factor would be most significant in this case because Respondent dispensed Levo Thyroid although Helle testified that she had previous reactions to another thyroid medication (Cytomel). Respondent's records contain no documentation of any abnormal thyroid function during Respondent's treatment of the patient. None of the medications dispensed by Respondent's office staff on May 4, 1984, were labeled in a manner which would identify the common name of the drug. Respondent inappropriately and excessively prescribed phentermine, phendimetrazine and Levo Thyroid to patient Helle, in that: The phentermine and phendimetrazine were prescribed and dispensed in excessive dosages; The phentermine and phendimetrazine were prescribed and dispensed on May 4, 1984, in combination (and in excessive dosages); Thyroid medication was prescribed on May 4, 1984, although Helle's thyroid was normal, according to information known to Warhola at that time; Thyroid medication was prescribed to be taken in combination with phentermine and phendime- trazine; and Respondent made no effort to treat Helle without drugs as a first line of treatment. Respondent failed to practice osteopathic medicine with acceptable levels of care, skill and treatment for the reasons listed in paragraph 72, above, and because Respondent did not examine or palpate Helle's neck for thyroid abnormalities on any visit, neither did an electrocardiogram nor listened to her heart sounds on two follow-up visits, and did not take her pulse on the first four of her five visits. In addition to the matters set out in paragraphs 72 and 73, above, Respondent's records for patient Helle were not adequate to justify Respondent's treatment in that: The records do not detail weight control programs the patient had tried, diet medications taken or recent history of weight gain or loss and diet; The records do not justify starting Helle at high dosages of phentimetrazine (much less in combination with the other drugs) on May 4, 1984; The records do not justify the Benadryl prescription; and the records do not detail what "swelling always" and "some fluid retention" notations mean, including the part of the body affected, the results of examination and Respondent's diagnosis.
Recommendation Based on the foregoing Findings Of Fact and Conclusions Of Law, it is recommended that the Board of Osteopathic Medical Examiners enter a final order holding Respondent, Michael J. Warhola, D.O., guilty of violating Sections 459.015(n),(q) and (t), Florida Statutes (1985), and suspending his license to practice osteopathic medicine for six months. RECOMMENDED this 4th day of March, 1987 in Tallahassee, Florida. J. LAWRENCE JOHNSTON Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of March, 1987.
Findings Of Fact At all times material hereto, Respondent has been a medical doctor having been issued license number 0029773 by the State of Florida. At all times material hereto, Respondent was an employee of the Atlantic Stress and Obesity Clinic, Inc., located in North Miami Beach, Florida. While employed there, Respondent treated Daniel Wolfenstein, Cindy Vegazo, Neal Schoenberg, James F. McDonald, Scott Brown and Virginia Hagerty at the Clinic. On or about October 9, 1981, Respondent prescribed 45 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Daniel Wolfenstein. Respondent did not prescribe the above-described controlled substance to Daniel Wolfenstein for a medically justifiable purpose. That prescription was inappropriate and in an excessive or inappropriate quantity. Between the dates of approximately March 10, 1981, and February 8, 1982, Respondent prescribed 405 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Cindy Vegazo. Respondent did not prescribe the above-described controlled substance to Cindy Vegazo for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. Between the dates of approximately October 9, 1981, and January 5, 1952, Respondent prescribed 90 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for Neal Schoenberg. Respondent did not prescribe the above-described controlled substance to Neal Schoenberg for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. Between the dates of approximately September 9, 1981, and January 22, 1952, Respondent prescribed 225 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for James F. McDonald. Respondent did not prescribe the above-described controlled substance to James F. McDonald for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. On or about October 13, 1981, Respondent prescribed 45 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for Scott Brown. Respondent did not prescribe the above-described controlled substance to Scott Brown for a medically justifiable purpose. Said prescription was inappropriate and in excessive or inappropriate quantity. Between the dates of approximately August 4, 1981, and December 29, 1981, Respondent prescribed 135 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Virginia Hagerty. Respondent did not prescribe the above-described controlled substance to Virginia Hagerty for a medically justifiable purpose. Said prescriptions were inappropriate and in excessive or inappropriate quantities. The medical records of each of the above-listed patients indicate that each patient was given a prescription for 45 methaqualone tablets each time that patient came to the Atlantic Stress and Obesity Clinic to see Respondent. All patients indicated on the form checklist given to them at the Clinic that they were seeking medical aid because they were depressed, tense, unable to sleep, and/or without ambition. The progress notes for each patient are identical to the notes from prior visits, all progress notes appear in two different handwritings, and all patients are diagnosed as suffering from anxiety and insomnia, thereby requiring 45 more methaqualone tablets. There appears no variation in dosage or in diagnosis. Methaqualone is a depressant, and, therefore, prescribing methaqualone to depressed patients is contraindicted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent guilty of Counts I through XIX of the Administrative Complaint and permanently revoking Respondent's license to practice medicine in the State of Florida. DONE and RECOMMENDED this 27th day of July, 1983, in Tallahassee, Leon County, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of July, 1983. COPIES FURNISHED: Charlie L. Adams, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Adolfo Z. Aguila, Esquire Midway Professional Building 55 Grand Canal Drive, Suite 404 Miami, Florida 33144 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy J. Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact The Respondent Walter L. Hurt is a licensed medical doctor having been issued license number ME 0007892. The last known address of the Respondent Hurt is 9871 Indigo Street, Perrine, Florida 33157. The Respondent's medical practice during the period set forth in the Administrative Complaint dealt primarily with weight control. Between approximately February 22, 1980 and August 11, 1981, the Respondent Hurt prescribed to Ms. Gloria Litton the following schedule II controlled substances as defined by Chapter 893, Florida Statutes: DATE DRUG AMOUNT 2/22/80 Sodium Amytal, 50 mg. 30 tablets 2/7/81 Sodium Amytal, 50 mg. 30 tablets 4/6/81 Sodium Amytal, 50 mg. 30 tablets 5/7/81 Sodium Amytal, 50 mg. 30 tablets 6/11/81 Sodium Amytal, 50 mg. 30 tablets 7/12/81 Sodium Amytal, 50 mg. 30 tablets 8/11/81 Sodium Amytal, 50 mg. 30 tablets 12/22/80 Dexedrine Sulfate, 5 mg. 30 tablets 2/26/81 Dexedrine Sulfate, 5 mg. 30 tablets 4/6/81 Dexedrine Sulfate, 5 mg. 30 tablets 5/7/81 Dexedrine Sulfate, 5 mg. 30 tablets 6/11/81 Dexedrine Sulfate, 5 mg. 30 tablets 7/12/81 Dexedrine Sulfate, 5 mg. 30 tablets 8/11/81 Dexedrine Sulfate, 5 mg. 30 tablets 1/14/80 Eskatrol Spans, 15 mg. 30 tablets No Date Tenuate Tabs, 25 mg. 60 tablets These drugs prescribed to Ms. Litton were excessive and inappropriate drugs for the purpose of weight loss. Between October 1, 1980 and December 1, 1980, the Respondent Hurt prescribed 90 tablets of Dexedrine, an amphetamine or sympathomimetic amine drug or compound designated as a schedule II controlled substance pursuant to Chapter 893, Florida Statutes to Ms. Litton for obesity. The drugs prescribed by the Respondent Hurt for Ms. Litton were ineffectual in treating her weight problem. In prescribing the type and quantity of controlled drugs for Ms. Litton, the Respondent failed to practice medicine with that level of care, skill and treatment required by a reasonably prudent similar physician confronted with the same conditions and circumstances. Moreover, the drugs were prescribed for a purpose outside the scope of Section 458.331(1)(cc), Florida Statutes, which prohibits prescribing an amphetamine or sympathomimetic amine drug except for certain enumerated purposes which do not include weight control. On January 29, 1981, the Respondent Hurt issued to Ms. Madeline Lyons a prescription for 30 tablets of Eskatrol Spansules, 15 mg. Further, on July 23, 1981, the Respondent Hurt issued a prescription to Ms. Lyons for 100 tablets of Fastin. These medications are amphetamines or sympathomimetic amine drugs or compounds designated as schedule II controlled substances pursuant to Chapter 893, Florida Statutes, and were given to Ms. Lyons by the Respondent for weight control. In prescribing these schedule II drugs for purposes of weight control, the Respondent failed to practice medicine with the degree of care, skill and treatment which is recognized as acceptable by a reasonably prudent similar physician confronted with similar conditions and circumstances. Moreover, these drugs were prescribed to Ms. Lyons for a purpose outside the scope of Section 458.331(1)(cc), Florida Statutes, which prohibits prescribing amphetamines or sympathomimetic amine drugs except for certain enumerated purposes which do not include weight control. Between approximately June 16, 1980 and October 1, 1981, the Respondent Hurt issued to Mr. Stephen Noel prescriptions for the following controlled substances as defined by Chapter 893, Florida Statutes. DATE DRUG AMOUNT 6/16/80 Preludin Endurets, 75 mg. 100 tablets 8/2/80 Preludin Endurets, 75 mg. 50 tablets 8/19/80 Preludin Endurets, 75 mg. 100 tablets 8/23/80 Preludin Endurets, 75 mg. 45 tablets 9/5/80 Preludin Endurets, 75 mg. 50 tablets 9/11/80 Preludin Endurets, 75 mg. 60 tablets 9/22/80 Preludin Endurets, 75 mg. 60 tablets 10/10/80 Preludin Endurets, 75 mg. 75 tablets 9/3/81 Didrex 100 tablets 9/17/81 Didrex 100 tablets 9/25/81 Didrex 100 tablets 10/1/81 Didrex 100 tablets The prescribing of these controlled substances by the Respondent Hurt to Mr. Noel was excessive and inappropriate for purposes of weight control. In prescribing excessive and inappropriate drugs, the Respondent engaged in gross or repeated malpractice or failed to practice medicine with the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Between approximately July 5, 1980 and October 1, 1981, the Respondent Hurt issued to Mrs. Edna Noel prescriptions for the following controlled substances as defined by Chapter 893, Florida Statutes: DATE DRUG AMOUNT 7/5/80 Preludin Endurets, 75 mg. 15 tablets 7/7/80 Preludin Endurets, 75 mg. 60 tablets 7/10/80 Preludin Endurets, 75 mg. 60 tablets 7/29/80 Preludin Endurets, 75 mg. 100 tablets 8/19/80 Preludin Endurets, 75 mg. 60 tablets 8/29/80 Preludin Endurets, 75 mg. 60 tablets 9/8/80 Preludin Endurets, 75 mg. 60 tablets 9/25/80 Preludin Endurets, 75 mg. 60 tablets 10/4/80 Preludin Endurets, 75 mg. 60 tablets 10/14/80 Preludin Endurets, 75 mg. 60 tablets 9/8/81 Didrex 100 tablets 9/12/81 Didrex 100 tablets 9/21/81 Didrex 100 tablets 9/28/81 Didrex 100 tablets 10/5/81 Didrex 100 tablets The prescribing of these controlled substances to Mrs. Edna Noel for purposes of weight control was excessive and inappropriate. In prescribing excessive and inappropriate controlled medications, the Respondent Hurt failed to practice medicine with the degree of care, skill and treatment which is recognized as acceptable by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The prescriptions issued by the Respondent to Mrs. Edna Noel on October 4 and 14, 1980, for 120 tablets of Preludin Endurets, 75 mg. were for weight control. Preludins are amphetamines or sympathomimetic amine drug or compounds designated as a schedule II controlled substance pursuant to Chapter 893, Florida Statutes. These schedule II controlled substances were prescribed for Mrs. Noel for a purpose outside the scope of Section 458.331(1)(cc), Florida Statutes which prohibits prescribing such drugs except for certain statutorily enumerated purposes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board of Medical Examiners issue a Final Order finding the Respondent guilty of violating Sections 458.331(1)(q), (t) and (cc), Florida Statutes (1981), and revoking his license. DONE and ORDERED this 28th day of December, 1982, in Tallahassee, Florida. SHARYN L. SMITH, 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 28th day of December, 1982.
