The Issue Whether Respondent committed the offense set forth in the Administrative Complaint and, if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency responsible for regulating the practice of medicine in Florida pursuant to Sections 20.165 and 20.43, and Chapters 456 and 458, Florida Statutes. Respondent is at all times material to this case a licensed physician in the state of Florida. As such, he is subject to disciplinary action for failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonable, prudent similar physician as being acceptable under similar conditions and circumstances. Iribar has been disciplined on two prior occasions. Both cases involved standard of care violations. In Case No. 113487, the Board of Medicine entered a Final Order on April 20, 1992, disciplining Respondent for multiple violations of Section 458.331(1)(t) related to, among other things, prescribing errors. In Case No. 1991-03407, the Board of Medicine entered a Final Order on July 17, 1995, disciplining Respondent for additional prescribing violations. On August 25, 1997, C. H. required medical attention for pain and swelling in his left knee. By the time he was "worked in" at the office of his primary care physician, C. H. was unable to get around without the aid of crutches. In seeking relief for his knee problem, C. H. set in motion a chain of events which would cost him his life. C. H. had been for years a patient at the clinic where Iribar practiced medicine in partnership with Dr. Raul Alvarez (Alvarez). C. H. had a complex medical history, and had long been under the care of Alvarez. Iribar had never seen C. H., but was covering his partner's emergencies on August 25, 1997. C. H.'s knee swelling, which was visible from across a medical examining room, plainly qualified as a matter which needed prompt attention. The clinic had an extensive chart on C. H. It contained records of many office visits, tests, and information concerning care received at other locations which occurred over a period of years in which Alvarez served as C. H.'s primary care doctor. As a partner in the practice, Iribar would of course have been authorized to read every word on the chart before, during or after C. H.'s visit. Numerous references in the chart address real or perceived allergies. At many places in C. H.'s chart, an allergy to aspirin in indicated. In many other places, C. H. is said to be allergic to penicillin as well as aspirin. Iribar's focus in his lone encounter with C. H. was totally upon the need for emergency attention to the swollen and sore knee. On August 25, 1997, it was the routine in the Iribar/Alvarez practice to maintain a form detailing the patient's history, including allergies, on the inside left cover of the file. C.H.'s chart had such a document and it reflected an allergy to penicillin. Iribar freely admits that he never looked at C. H.'s chart prior to prescribing penicillin for his injured knee. Instead, Iribar testified that he conversed with C. H. while examining him and felt that he could obtain from C. H. an accurate answer to the question of whether he was allergic to any medications. During the examination and treatment process, C. H. was articulate regarding his complex medical history. He enumerated at least six medications which he was currently taking. Iribar testified that he asked C. H. if he was allergic to any medications and C. H. responded "aspirin." Iribar states that he informed C. H. that he was going to place him on oral penicillin, which might later be discontinued depending upon the outcome of lab results. According to Iribar, C. H. failed to inform him of a penicillin allergy. For reasons more fully set forth below, the undersigned does not credit Iribar's recollection that he in fact asked C. H. if he had allergies. Neither does the undersigned credit Iribar's testimony to the effect that he informed C. H. of his intent to administer penicillin. Apart from that dispositive fact, the undersigned does credit Iribar's account of his encounter with C. H. Based upon that testimony and the corroborating opinion of the experts for both sides, the evidence established that Iribar entered the examining room and noted that C. H. had a large left knee effusion with pain, redness, and increased temperature to touch. Iribar properly performed an arthrocentesis (a puncture through a joint capsule to relieve an effusion), removing 20cc of yellow pus-like material to relieve the pain. He then prescribed ibuprofen for pain and Pen VK, which is in fact penicillin, to prevent infection. Penicillin is, for most patients, safe and effective for the prevention of infection following a procedure such as the one performed on C. H. Alternative antibiotics exist and would have been prescribed for C. H. had Iribar been aware of the existence of a possible allergy. For an allergic patient such as C. H., the result of taking penicillin can be, and in this case was, swift cardiac arrest followed by a coma from which the patient never emerged. He died five months later. Expert witnesses for both sides agree, and the undersigned finds, that it would have been a gross violation of the standard of care to prescribe penicillin to a person known to be allergic. There is no contention that Iribar actually knew of the allergy, and Iribar did not intend any harm to C. H. Instead, the evidence established that Iribar was covering his partner's emergency and trying to help the patient. Thus, the issue is whether Iribar fell below the standard of care of failing to take reasonable steps to determine whether C. H. had a penicillin allergy. In this case, the totality of the record compels the conclusion that Iribar did not take even a first step. He did not inquire of C. H. as to whether he had any allergies, nor did he look at the patient's chart, which would have placed him on inquiry notice regarding the existence of a penicillin allergy. In failing to take either precaution, he fell below the standard of care. Iribar's disciplinary history reveals prior failures in adhering to the standard of care with respect to the professional obligation to ask the questions a doctor needs to ask to determine if a drug should or should not be prescribed. Additionally, his careless response to the Board of Medicine's inquiry regarding his treatment of C. H. is telling. In an undated letter to Board investigator, Lidice Muniz, Iribar stated, ". . . I asked the patient in front of two medical assistants aiding me [Ana Dickinson and Barbara Olesco] if he was allergic to any medication, he replied 'Aspirin' and he denied all other drug allergies." Common sense suggests that Iribar would have been scrupulously accurate in communicating in writing to state investigators about a matter of such importance. Thus, the undersigned takes seriously Iribar's statement that two assistants witnessed the exchange referenced in the letter. Yet, at the final hearing, neither Iribar nor Olesco claimed that this exchange was witnessed by one, let alone two medical assistants. The undersigned carefully observed Iribar's demeanor while under oath. His recollection that he engaged C. H. on the question of allergies is determined to be untrustworthy. Specifically, the undersigned does not credit Iribar's assertion that he asked his patient about allergies. In light of this finding, it is not necessary to address whether Iribar would have been bound to review the chart had C. H. in fact been asked about allergies. With respect to C. H., Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances in that he failed to take any step to afford himself the opportunity to know what if any allergies C. H. had prior to prescribing the medication which caused the patient's death.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law and having reviewed the Recommended Range of Penalty under the Florida Administrative Code, it is RECOMMENDED that the Board enter a final order finding Respondent guilty and imposing the following penalty: A fine of $10,000; continuing medical education classes specified by the Board of Medicine; a six- month suspension; two years of probation, with terms set by the Board of Medicine; a letter of reprimand; and requiring Respondent to report to the Board of Medicine regarding procedures he has or will implement to assure appropriate inquiry of patients regarding their allergies in accordance with the standard of care currently prevailing. It is also RECOMMENDED that the Board impose costs associated with the investigation and prosecution of this case in compliance with Section 456.072(4), Florida Statutes. DONE AND ENTERED this 14th day of January, 2003, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS 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 14th day of January, 2003. COPIES FURNISHED: Sean M. Ellsworth, Esquire Dresnick, Ellsworth & Felder, P.A. 201 Alhambra Circle Sun Trust Plaza, Suite 701 Coral Gables, Florida 33134-5108 John E. Terrel, Esquire Department of Health 4052 Bald Cypress Way Bin C-65 Tallahassee, Florida 32399-3265 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue The issue in this case is whether Florida Administrative Code Emergency Rule 65DER17-2 (the “Emergency Rule”) constitutes an invalid exercise of delegated legislative authority as defined in section 120.52(8), Florida Statutes. (Unless specifically stated otherwise herein, all references to Florida Statutes will be to the 2017 version.) More specifically, on September 19, 2017, the Florida Department of Children and Families (the “Department”), published the Emergency Rule, which dealt with the need for and licensing of new methadone medication-assisted treatment centers for persons dealing with opioid addiction. Pursuant to the Emergency Rule, the Department decided which providers would receive approval notices to submit licensure applications in certain counties based on the order in which complete and responsive applications were received by the Department. A number of parties are challenging the validity of the Emergency Rule.
Findings Of Fact Parties and Standing Respondent, the Department, is the state agency responsible for licensing providers of care in methadone medication-assisted treatment facilities. It is the agency, which promulgated the Emergency Rule. Petitioner, Dacco Behavioral Health, Inc. (“Dacco”), is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Dacco submitted three applications for licensure under the Emergency Rule. Its applications were not approved by the Department. Dacco timely filed an administrative challenge to its denied applications. Dacco has standing in this proceeding. Petitioner, OPI, is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. OPI submitted six applications for licensure under the Emergency Rule. None of its applications were approved by the Department. OPI timely filed an administrative challenge to its denied applications. OPI has standing in this proceeding. Petitioner, Aspire Health Partners, Inc. (“Aspire”), is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Aspire submitted two applications for licensure under the Emergency Rule. Neither of its applications was approved by the Department. Aspire timely filed an administrative challenge to its denied applications. Aspire has standing in this proceeding. Intervenor, CRC, is a Delaware limited liability company registered to do business in Florida. CRC is currently licensed to operate a methadone medication-assisted treatment clinic in Florida. CRC submitted 16 applications for licensure under the Emergency Rule. Its applications were not approved by the Department. CRC timely filed an administrative challenge to its denied applications. CRC has standing to intervene in this proceeding. Intervenor, Riverwood Group, LLC (“Riverwood”), is a Delaware limited liability company authorized to do business in Florida. Riverwood is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Riverwood submitted six applications for licensure under the Emergency Rule. Its applications were not approved by the Department. Riverwood timely filed an administrative challenge to its denied applications. Riverwood has standing to intervene in this proceeding. Intervenor, Symetria, is a Florida limited liability company whose parent company is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Symetria submitted 11 applications for licensure under the Emergency Rule. One of its applications was approved; the other 10 were not approved by the Department. Symetria did not file an administrative challenge to the denial of its applications. Opposition to Symetria’s standing was raised by Intervenors appearing in support of Respondent. Symetria was allowed to participate at final hearing pending adequate proof of standing. Symetria did not prove its standing at final hearing. Symetria does not have standing in this proceeding on behalf of Petitioners as it does not satisfy the two-prong test announced in Agrico Chemical Company v. Department of Environmental Regulation, 406 So. 2d 478 (Fla. 1st DCA 1978). (After entry of this Final Order, Symetria will be stricken from the style of the case.) It should be noted that Symetria apparently never received notice as to its denied applications and may have challenged those denials, if notices had been issued, but that possibility is too speculative to award standing in this matter. It should also be noted that none of the parties hereto objected to Symetria’s involvement in the final hearing, including its introduction of evidence and examination of witnesses. Intervenor, CFSATC, d/b/a Central Florida Substance Abuse (“CFSATC”), is a Florida corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. CFSATC submitted seven applications for licensure under the Emergency Rule. None of its applications were approved by the Department. CFSATC timely filed an administrative challenge to its denied applications. CFSATC has standing to intervene in this proceeding. Intervenor, Bay County Healthcare Services, LLC (“Bay County Healthcare”), is a Georgia limited liability company and is currently licensed to operate a methadone medication- assisted treatment clinic in Florida. Bay County Healthcare submitted eight applications for licensure under the Emergency Rule. None of its applications were approved by the Department. Bay County Healthcare timely filed an administrative challenge to its denied applications. Bay County Healthcare has standing to intervene in this proceeding. Intervenor, Palm Beach Drug Testing, LLC, d/b/a Relax Mental Health Care (“Relax”), submitted 14 applications for licensure under the Emergency Rule; eight of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of Relax. Relax has standing to intervene in this proceeding. Intervenor, Colonial Management Group, L.P. (“Colonial”), operates methadone medication-assisted treatment centers nationwide, including Florida. Colonial submitted 19 applications for licensure under the Emergency Rule; all 19 of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of Colonial. Colonial has standing to intervene in this proceeding. Intervenor, PAS, submitted 48 applications for licensure under the Emergency Rule; twenty of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of PAS. PAS has standing to intervene in this proceeding. Procedural History On May 3, 2017, Governor Scott signed Executive Order No. 17-146, alluding to the nearly 4,000 deaths in Florida caused by opioids during calendar year 2015. Florida had nearly 10 percent of all opioid-related deaths in the entire country that year. The Governor declared that an opioid epidemic threatens the State and has created an emergency situation. He directed the State Health Officer and Surgeon General to announce a statewide public health emergency. The Governor’s executive order noted that the United States Department of Health and Human Services had awarded a grant of $27,150,403 per year for two years to the Department to provide prevention, treatment, and recovery support services to address the opioid epidemic. The Governor said it was necessary to immediately draw down those federal grant funds in order to provide services to Florida communities, and that the State could not wait until the next fiscal year (which would start two months hence, on July 1, 2017) to begin that distribution. On June 29, 2017, the Governor signed Executive Order No. 17-177, extending for an additional 60 days the state of emergency declaration set forth in Executive Order 17-146. This action was precipitated by hurricanes threatening the State. The executive orders issued by the Governor appear to direct State agencies to utilize the federal grant monies to bolster existing providers of treatment. Nothing in the executive orders issued by the Governor directs the approval of additional opioid treatment centers. There is, however, an omnibus provision in the executive order directing the State Health Officer to “take any action necessary to protect the public health.” The Department’s response to the executive orders was to publish emergency rule 65DER17-1 in the FAR on August 25, 2017. That rule was superseded by the Emergency Rule, which revised the dates during which applications for licensure could be submitted. This change was deemed necessary in response to the devastation wrought by Hurricane Irma, making travel to Tallahassee (for delivery of applications) somewhat difficult during the timeframes set forth in emergency rule 65DER17-1. The Notice of Emergency Rule, as published in the Florida Administrative Register, states in full (with strikethrough/underline in original): Notice of Emergency Rule DEPARTMENT OF CHILDREN AND FAMILIESSubstance Abuse Program RULE NO.: RULE TITLE: 65DER17-2 Standards for Medication-Assisted Treatment for Opioid Addiction SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE: On May 3, 2017, the Governor of the State of Florida signed Executive Order Number 17-146 declaring that the opioid epidemic threatens the State with an emergency and that, as a consequence of this danger, a state of emergency exists. Also, in the executive order, the Governor directed the State Health Officer and Surgeon General to declare a statewide public health emergency, pursuant to its authority in section 381.00315, F.S. On June 29, 2017, the Governor signed Executive Order Number 17-177 to extend the state of emergency declaration. The department was recently awarded a two-year grant to address this opioid epidemic. The department will use these funds in part to expand methadone medication-assisted treatment services in needed areas of the state as part of a comprehensive plan to address the opioid crisis. Revising the licensure requirements through an emergency rule is necessary to accommodate the critical need for more methadone medication-assisted treatment providers. Due to the impact of Hurricane Irma on providers and individuals in treatment, the department has determined that extending the submission dates for applicants is necessary. REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: The procedure is fair under the circumstances because it ensures equitable treatment of methadone medication-assisted treatment providers. SUMMARY: This rule makes changes to permanent Rule 65D-30.014 F.A.C., relating to licensure requirements for methadone medication-assisted treatment programs. THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Bill Hardin. He can be reached at William.Hardin@myflfamilies.com or Office of Substance Abuse and Mental Health, 1317 Winewood Boulevard, Building 6, Tallahassee, Florida 32399-0700. THE FULL TEXT OF THE EMERGENCY RULE IS: 65DER17-2 (65D-30.014): Standards for Medication-Assisted Treatment for Opioid Addiction. 65DER17-2 supersedes 65DER17-1. In addition to Rule 65D-30.004, F.A.C., the following standards apply to Standards for Medication-Assisted Treatment for Opioid Addiction. State Authority. The state authority is the department’s Office of Substance Abuse and Mental Health. Federal Authority. The federal authority is the Center for Substance Abuse Treatment. Determination of Need. Criteria. In accordance with s. 397.427, F.S., the department shall not license any new medication-assisted treatment programs for opioid addiction until the department conducts a needs assessment to determine whether additional providers are needed in Florida. The determination of need shall only apply to methadone medication-assisted treatment programs for opioid addiction. Department of Correction facilities are excluded from this process. The department shall use a methodology based on a formula that identifies the number of people who meet the criteria for dependence or abuse of heroin or pain relievers who did not receive any treatment, and the number of opioid-caused deaths. This formula will be weighted, with 70 percent driven by the number of people with an unmet need for treatment and 30 percent driven by the number of deaths. In its effort to determine need, the department shall examine the following data: Population estimates by age and by county; Number of opioid-caused deaths; Estimated number of past-year nonmedical pain reliever users; and Estimated number of life-time heroin users; Procedure. By August 28, 2017, the department will conduct a needs assessment to determine whether additional methadone medication-assisted treatment providers are needed in Florida. The department will publish a determination of need in the Florida Administrative Register and on the department’s website at http://www.myfl families.com/service-programs/substance- abuse on August 30, 2017. If the department determines that additional providers are needed, the department will also publish instructions for submitting an appropriate application. Applicants interested in providing methadone medication-assisted treatment must complete and submit CF-MH 4036 titled, “Methadone Medication-Assisted Treatment Provider Application in Response to Emergency Rule”, June 2017, incorporated herein by reference. Form CF-MH 4036 is available from the department’s website at https://eds.myflfamilies.com/DCFForms Internet/Search/DCFFormSearch.aspx and at http://www.myflfamilies.com/service- programs/substance-abuse. Applications must be complete and responsive to all of the questions on this form. Applications will be accepted at department headquarters from October 2, 2017 September 22, 2017 at 8 a.m. Eastern Time until October 23, 2017 October 13, 2017, at 5 p.m. Eastern Time. Applications must be delivered to the following address: Florida Department of Children and Families, Office of Substance Abuse and Mental Health, 1317 Winewood Boulevard, Building 6, Tallahassee, Florida 32399-0700. For the application review period in response to this emergency rule, the department will use CF-MH 4037 titled, “Review Form for Methadone Medication- Assisted Treatment Provider Application in Response to Emergency Rule”, June 2017, incorporated herein by reference. Form CF- MH 4037 is available from the department’s website at https://eds.myflfamilies.com/ DCFFormsInternet/Search/DCFFormSearch.aspx and at http://www.myflfamilies.com/service- programs/substance-abuse. Should the number of applications for a new provider in a Florida county exceed the determined need, the selection of a provider shall be based on the order in which complete and responsive applications are received by the Office of Substance Abuse and Mental Health headquarters. Applicants who are approved to apply for licensure will receive notices from the department by November 17, 2017 November 10, 2017. Applicants who receive approval notices shall submit applications for licensure to the department’s regional Substance Abuse and Mental Health office(s) where the service will be provided. The regional Substance Abuse and Mental Health office will process applications for licensure in accordance with the standards and requirements in 65D-30, F.A.C. through (6) No change. Rulemaking Authority 397.321(5) F.S. Law Implemented 397.311(25)(a)7., 397.321(1), 397.419, FS. History–New 5-25-00, Amended 4-3-03, Amended 8-25-17, Amended 9-19-17. THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE. EFFECTIVE DATE: 9/19/2017 Petitioners filed challenges to the Emergency Rule at DOAH on December 11, 2017, 83 days after the effective date set forth in the FAR. Respondent asserts that the Emergency Rule is merely an amendment to Rule 65DER 17-1, which had an effective date of August 25, 2017. Thus, reasons Respondent, challenges to the Emergency Rule were due on or before November 23, 2017, i.e., 90 days after August 25, 2017. However, emergency rules are not renewable so as to expand their validity beyond 90 days. § 120.54(4), Fla. Stat. As set forth above, the clear language appearing in the FAR establishes September 19, 2017, as the effective date of the Emergency Rule. Had the Department wished to retain the effective date from the prior rule, it certainly could have done so. It did not. Petitioners’ challenge to the Emergency Rule was timely. Background Florida has had rules in effect for 18 years regarding the need for opioid treatment centers around the State. Florida Administrative Code Rule 65D-30.014 is entitled, “Standards for Medication and Methadone Maintenance Treatment.” This rule sets forth the process for providers to request licenses to establish new opioid treatment facilities, based on the Department’s annual determination of need. According to the rule, the Department is to conduct an annual assessment of need, publishing the results of that assessment by June 30 of each year, although, inexplicably, no assessment was done for calendar years 2016 or 2017. After the need assessment is published, the Department directs interested parties to submit applications for licensure to the Department’s district office in the area where the need exists. All such applications would have to be submitted no later than on a “closing date” to be provided by the Department. The Department’s district office would receive the application(s) and conduct a formal rating of the applicant(s). There were minimum requirements each applicant must meet in order to be considered for licensure. If the number of applicants exceeded the determined need, the selection of a provider would be done based on certain substantive criteria, e.g., number of years the applicant has been licensed; the organizational capability of the applicant; and the applicant’s history of noncompliance with Department rules. Pursuant to rule 65D-30.014, the Department had conducted assessments in calendar years 2012, 2013, 2014, and 2015. The award of licenses based on the 2012 and 2013 need assessment was delayed by litigation. A need for 31 additional treatment centers was found in 2014, but no applications were accepted by the Department due to the ongoing litigation relating to the previous years. The following year, 2015, the Department found a need for only five additional treatment centers, even though none of the 31 treatment centers identified as needed in 2014 had been awarded to anyone. The 2015 assessment was lower than the prior year due to some changes in the methodology used by the Department. The Department did not accept any applications to meet the established need in 2015. One rationale for not accepting applications, even though there was a need, was that the Department was drafting new rules. That process would give stakeholders an opportunity for input. The notices that the rules were being developed, however, were not filed until some 11 months after the 2015 need projections were published. The Department explained that it was busy with other rulemaking duties during that time, causing some delay. Developing the Emergency Rule After entry of the Governor’s executive orders, the Department began the process of distributing the federal grant money to existing treatment centers. The Department, though it never met with the Governor to discuss use of the grant funds, handed out the funds to various existing clinics in order to help them deal with the clinics’ backlogs and waiting lists. There was no discussion between the Governor and the Department concerning the necessity for new clinics. A needs assessment was apparently conducted by the Department. The Department based its assessment in part on data it had gathered when applying for the federal grant. Existing treatment centers had provided the Department waiting lists, indicative of a greater need than could be met by the existing clinics. That data, however, was only from public providers; private providers were not included. The public providers were essentially those contracting with the Department’s “managing entities,” who act as intermediaries between the provider and the Department. An emergency rule was proposed as the vehicle for addressing the need and acquiring applications for licensure. Though the Department’s Director of Substance Abuse and Mental Health thought it best to simply proceed with the rule currently under development, the Emergency Rule was pursued. The thinking at the Department was that the existing rule had created considerable litigation that the Emergency Rule might avoid. That did not happen. The emergent situation warranting an emergency rule was, according to the Department, the scenario described by the Governor in his executive orders. The Department of Health had declared a public health emergency, which was also used as a basis for creating the Emergency Rule. The federal grant funds, however, were not an impetus for creating the Emergency Rule. The Emergency Rule relied upon data from calendar year 2015, as it was the latest data available to the Department at that time. The Governor’s executive orders had also relied upon 2015 data. Some interim data had been available, but the only full year of information available at the time the rule was promulgated was for 2015. The interim data, however, indicated a sharp (approximately 30 percent) increase in need. The Department published a determination of need on its website on August 30, 2017. Apparently the need determination was not published in the FAR despite the directive to do so in subsection (3)(b) of the Emergency Rule. The Department found a need for one clinic each in 47 of Florida’s 67 counties, as well as for two in Hillsborough County, for a total of 49 new clinics. Pursuant to the Emergency Rule, interested applicants were to file an application on the Department’s approved form (CF-MH 4036, attached hereto as an Addendum) expressing an interest in becoming licensed in one or more of those counties. Such applications were to be “accepted at department headquarters from October 2, 2017, at 8 a.m., Eastern Time, until October 27, 2017 at 5 p.m., Eastern Time. Applications must be delivered to [the department].” In contrast to rule 65D- 30.014, applications under the Emergency Rule were to be filed at the Department’s headquarters in Tallahassee rather than in the various district offices around the State. The application form utilized by the Department is a one-page document. The form requests minimal identification information concerning the applicant and its business (questions 1 through 10). Question 11 asks if the applicant plans to accept Medicaid-eligible, indigent, and/or pregnant women as patients. The 12th question directs the applicant to submit documentation concerning its target population, proof of a physician on staff, the anticipated date of initiation of services, and proof of registration with the Department of Revenue or Division of Corporations. The Department also created a “review form,” used to check the completeness of applications. The review form mirrors the application, providing a space for the Department reviewer to state whether the applicant had completed each section of the application form. The Department maintains that the applicants’ responses to Question 11 were not considered in its review of the applications submitted under the Emergency Rule. This was because, according to the Department, a response to that question might favor one applicant over another. The Department did not elaborate as to how this “favoritism” might negatively affect the process. The question had been used under the prior rules and had been deemed important, presumably because--as reported by some of the parties herein--a large majority of their patients were either Medicaid-eligible, indigent persons, or pregnant women. It certainly was reasonable that the Department would ensure that those groups of citizens, who were undoubtedly accounted for in the need assessment, had access to approved treatment centers under the Emergency Rule. Nonetheless, the Department did not utilize the Question 11 responses in its review. This is contrary to the plain language of the Emergency Rule, which states: “Applications must be complete and responsive to all questions on this form.” (emphasis added). See 65DER17- 2(3)(b)1. The Emergency Rule as published contained the following language: “REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: The procedure is fair under the circumstances because it ensures equitable treatment of methadone medication-assisted treatment providers.” Neither the Emergency Rule language nor the Department at final hearing provided a persuasive rationale for that statement and conclusion. In fact, the Department acknowledged that if the first person in line had filed applications for all 49 new clinics, all the other applicants would have been denied the right to seek licensure. How is that fair? What the Emergency Rule did was to set a window within which interested applicants could either mail, overnight-deliver, or hand-deliver a copy of the one-page application and attachments to the Department’s headquarters in Tallahassee. The Department felt that allowing applications to be submitted via email would potentially crash its email system, so email submission was not allowed. The applications received first by the Department were to be approved, notwithstanding any substantive shortcomings or comparative failings of those applications as compared to applications received later. No other criteria were considered; first was deemed best. What is fair about approving competing applications based on who filed first rather than on substantive differences in the services being proposed? What actually transpired vis-à-vis submission of the applications was not foreseen by the Department or by most of the applicants. That is, some applicants either lined up at Department headquarters days prior to the 8:00 a.m. acceptance time on October 2, 2017, or had someone wait in line for them. Then, when the doors opened at 8:00 a.m., the first person in line presented applications for 19 of the 49 sites identified by the Department as having a need. The second applicant in line submitted 17 applications, etc. By the time each of the Petitioners reached the front of the line, only minutes after the doors had opened, applications for their prospective counties of interest had already been filed. Under the Emergency Rule, the earlier filed applications were accepted without comparison to competing applications. As a result, Colonial was approved for 19 licenses; PAS was approved for 20; and Relax obtained eight; i.e., 47 of the 49 licenses were obtained by just three individual applicants. Again, the Department acknowledged that “[a]fter it, you know, happened the way it did, there were many considerations that we should have made.” Ute Gazioch, Jt. Exh. 6, page 81. Interestingly, the first application accepted by the Department was by an applicant who did not even appear at Department headquarters. That applicant, Lakeview Center, Inc., submitted its application via FedEx. The FedEx box containing Lakeview Center’s application was received and clocked in by an office at Department headquarters, other than the Substance Abuse and Mental Health office, at 7:40 a.m., i.e., prior to the window for filing. When the application made its way to the appropriate office, it was deemed received at 8:00 a.m. As a result, it was “first in line.” The incongruity of that situation was not persuasively justified by the Department. In fact, the Department testified that if all of the applications had been filed at the wrong office, it would likely have simply defaulted to an 8:00 a.m. arrival time for each one. Upon being approved, an applicant would then be allowed to submit an application for licensure. Under the licensure process, the applicant would be vetted in order to assure it met at least minimal requirements for obtaining a license. No comparison of the approved applicant to other applicants was made by the Department to ascertain whether another applicant might be superior as to services provided. Rather, if the approved applicant could satisfy, even minimally, the licensure requirements, it would be granted the right to seek a license. Once licensed, it could take considerable time and financial resources to effectuate the opening of a new opioid treatment clinic. There are many factors to be addressed and resolved, including but not limited to: acquisition of an appropriate site, whether by way of purchase of undeveloped property and new construction or lease/purchase of an existing building; construction or renovation, as needed; zoning concerns; permitting by state, county, and/or municipal bodies; staffing; coordination of state and federal licenses or certifications; etc. It is not uncommon for the process to take up to two years, sometimes more. In addition, the financial expenditures could be in the hundreds of thousands of dollars (and even as much as a million dollars) for each project. For this reason, the Department did not foresee that any entity might apply for so many applications as actually transpired. The likelihood that a single entity would have the time, money, or other resources to move forward on multiple products at one time is small. It is more likely that a single entity receiving approval for multiple new clinics might “bank” the approvals, expending time and money for only a few at a time, at best. If so, that could result in far fewer new clinics coming on line than the 49 projected by the Department under the Emergency Rule. As the applications contained no requirement to provide financial information, it is impossible for the Department to determine whether the approved entities, which received multiple approvals, could successfully–-and timely–-complete their projects. There is no specific time frame for which a granted applicant must commence operations once approved. However, as the approvals were done pursuant to an “emergency,” it follows that clinics should be opened as soon as practicable. Petitioners assert that the “first in line” scheme enunciated in the Emergency Rule is arbitrary, capricious, and patently contrary to a determination of the applicants’ ability to provide care to persons suffering opioid addiction. The facts bear that assertion out.
Findings Of Fact The Respondent, Clayton E. Linkous, Jr., M.D., at all times pertinent to this proceeding, has held a current and valid medical license issued by the Board of Medical Examiners of the Department of Professional Regulation. The Petitioner is an agency of the State of Florida charged with enforcing the requirements of Chapter 458, Florida Statutes, and appurtenant rules involving the licensing of physicians, the regulation of their licensure status and the enforcement of standards of professional practice of physicians it licenses to practice in the State of Florida. The Respondent received his medical degree from the University of West Virginia Medical School. Be entered the Navy and served a "rotating internship" at Bethesda Naval Hospital. He was on the staff at Bethesda Naval Hospital for approximately one year. The Respondent then came to Pensacola for Naval Flight Surgeon training and was ultimately assigned to Camp Pendleton, California. The Respondent later was assigned to Vietnam with the Marine Corps as a Flight Surgeon and General Surgeon. Upon concluding his tour of duty in Vietnam, the Respondent returned to the Naval Air Station in Pensacola where he was placed in charge of the Division of Physical Evaluation of Aviation Medicine, serving in that post for some two and a half years. The Respondent resigned from the service and opened a practice of emergency medicine at Sacred Heart Hospital in Pensacola, serving in that capacity for approximately four years. The Respondent then entered private practice in the areas of acute medicine and family practice, which practice he was engaged in at the time of the hearing. The Respondent is a member of the County Medical Society in Escambia County, the American Medical Association, Southern Medical Association, Association of Military Surgeons and a Charter Member of the American College of Emergency Physicians. The Respondent is current on continuing medical education requirements through September, 1983. In January of 1978, Mrs. Julie Hebert visited the Respondent with complaints of a recent weight gain of 7 pounds and sleeping long hours. Mrs. Hebert weighed approximately 101 pounds at that time. The Respondent treated Mrs. Hebert for sleeping long hours and for depression, for which he prescribed antidepressants as well as anorexiants, which are appetite suppressors. During his course of treatment of Mrs. Hebert on this and later occasions, the Respondent failed to record her height, which has a direct relationship to a determination of her ideal weight, although he was treating her to alleviate a supposed excessive weight gain. The Respondent also failed to take a psychosocial or neurological examination of Mrs. Hebert and thus, of course, failed to make a written record of any such examination or history. The Respondent made a diagnosis of obesity. The patient complained of a 7 pound weight gain and her weight was 101 pounds, but if a diagnosis of obesity is made, the usual and reasonable course of treatment for a physician engaged in family practice is to try and predict an ideal body weight or weight loss goal, interview the patient extensively with regard to diet habits, exercise habits and then try to make recommendations to modify those in order to alleviate the diagnosed condition of obesity. This should always be done before an anorexiant drug is prescribed and the appropriate standard of care for a patient with a diagnosis of obesity does not consist of merely prescribing anorexiants to suppress appetite. Anorexiants suppress the appetite control center of the brain. Their use can be helpful to suppress appetite during the first few weeks of treatment for obesity, but they must be prescribed as a part of a total program of weight control consisting of diet modification and exercise on a long-term basis. Anorexiants provide a diminishing return in their benefits in treating obesity because, as their use continues, their effectiveness diminishes and an increasing dose is required as a few weeks elapse. The need to increase the dosage to achieve the same effect of suppressing appetite, and therefore weight control increases geometrically. Thus, if their dosages continued at or near the originally prescribed amount, the anorexiant soon no longer has the effect of suppressing the patient's appetite and the patient has nothing helping him to lose weight unless an appropriate diet and exercise program was thoroughly discussed and prescribed. On the other hand, if anorexiant dosages are increased as their beneficial effect diminishes, then the serious side effects of anorexiant drugs come into play. Anorexiants cause an elevated pulse rate and an increased body temperature similar to that of an adrenaline response or "high active state." Anorexiants are amphetamines or "amphetamine-analogue" drugs, which, because of their stimulative effects, often cause cardiac arrhythmias and increasing dosages can often prove seriously harmful or fatal to a patient. Because of these potentially dangerous effects of anorexiant medications and because their use necessitates geometrically increasing dosages in order to remain effective in weight control, the use of such "amphetamine- family" anorexiants is inappropriate in a patient like Julie Hebert, particularly because of her age of 17 years, because of the potential for causing serious heart rhythm abnormalities and possible death, as well as the addictive potential of such increasing dosages. The use of anorexiants were especially contraindicated in the case of patient Hebert because no long-term diet and exercise modification program was discussed with the patient nor prescribed and the diagnosis of obesity, when the patient reported a recent weight gain of only 7 pounds and only weighed approximately 101 pounds on the first examination, was established to be incorrect. (Cohen deposition; Petitioner's Exhibit 2) The Respondent also diagnosed Julie Hebert, as suffering from depression. The appropriate standard of care in treating depression is a thorough consultation with the patient about depression, its causes and means for alleviating it. A family practitioner practicing an appropriate standard of care in dealing with depression should recommend counseling for the patient herself, as well as involving her family and should take an extensive psychosocial history of the patient's personal and family background in order to assist him in determining the causes of her depression. The Respondent failed to do this in this case. Instead he immediately prescribed two antidepressant medications, which, without the accompanying consultation and counseling and eliciting of a detailed history, can be a potentially dangerous deviation from the standard practice when dealing with such a 17-year-old patient. Antidepressant medication, when appropriately prescribed, requires approximately four weeks to exert its full, antidepressant effect. Its benefit is not immediate, but rather is a cumulative effect. This patient's antidepressant medications, however, were changed frequently. Two medicines were prescribed the first visit and two different antidepressant medications were prescribed on the next visit and still a third medication prescribed on the her third visit, all in the space of less than two months. In fact, on her third visit a major phenothiazine tranquilizer was prescribed when, according to the Respondent's notes, the patient seemed anxious and agitated. That type of medication is used to treat schizophrenia or a major psychosis. There is no psychosocial history in the case of Julie Hebert to indicate that she had or ever had a psychosis which would justify prescribing that drug, especially in view of the fact that it represented a third change from the previous course of antidepressant medications prescribed. The changing of antidepressant medications three times in less than two months is not a course of treatment followed by reasonable, prudent general practitioners or family practitioners in treating such a patient because an insufficient opportunity was provided for the initial medications prescribed to render their full beneficial effects before their use ceased. Further, the doctor prescribed three different amphetamine-family medications in less than three weeks and failed to keep any record of the amounts of any of those medications. The use of such amphetamine-family drugs or anorexiants has no therapeutic place in diet therapy, especially with a 17-year-old girl who only weighs approximately 101 to 105 pounds. On April 18, 1978, patient Gloria Brock visited Respondent at his office complaining of a weight problem. At that visit the Respondent failed to record the patient's height and failed to record an ideal body weight or any weight loss goals. No record was made of the patient's diet habits or exercise habits, nor the type of therapy he prescribed for her. The doctor did prescribe a substantial number of medications. He prescribed diuretics, thyroid medication and amphetamine-family anorexiants. The doctor prescribed Tofranil, an antidepressant; Valium, a minor tranquilizer; Oretic, a diuretic; Thyrolar, a thyroid hormone; Ionamin and Bacarate, both amphetamine analogue medications; and well as Midrin, a headache medication. The sole diagnosis underlying these prescriptions was the patient's weight problem. The doctor next saw this patient on May 9, 1978, at which time he refilled the prescriptions for the previous medications and added a prescription for Phenaphen #2, a narcotic analgesic and Didrex, a different diuretic medication. On that visit she had an additional complaint of mild muscle tenderness in her neck. On June 15, 1978, she came in complaining of additional problems involving miofasciculitis and vascular cephalgia (sore muscles and headaches). He refilled the previous medications, except the Oretic and Tofranil, and added a prescription for Elavil, which is a different anti-depressant from that previously prescribed. He also increased the dose of thyroid hormone. On July 17, 1978, she again visited the Respondent's office and he administered an injectable medication called Vernate, a decongestant and antihistamine combination. Vernate has no therapeutic purpose with a patient in Mrs. Brock's medical situation. The patient also received an injection of Keflex, as well as Comhistla and Ionamin injections. Keflex is an antibiotic. The Respondent had made a note on that date that he thought her ear canal was inflamed or infected. The Keflex was used, however, in conjunction with Terramycin, which is a brand of Tetracycline, the use of which in combination with Keflex is wholly inappropriate. The use of the antibiotic Keflex with the antibiotic Tetracycline is incompatible and the Tetracycline actually will impair the effect of the Keflex prescription. Comhistla is an antihistamine decongestant and Ionamin is a amphetamine-family anorexiant. On September 6, 1978, the Respondent prescribed to her Parafon Forte, a muscle relaxant; Triaprin DC, which is an analgesic containing synthetic Codeine; Histalet, an antihistamine and Minocin, an antibiotic. No record was made by the Respondent of any of these prescriptions. The next office visit was October 23, 1978. No complaints by the patient were recorded for that date, but some physical findings were noted such as her weight (121 3/4 pounds) and that her nasal mucus membranes were swollen. The patient received three injectable medications that date; Iatric, a multi- vitamin combination that is combined with Testosterone and Estrone. That medication is designed for geriatric use and has no therapeutic value in treating Mrs. Brock, a 38-year-old patient with no symptoms indicating its use. She was also injected with vitamin B-12. The only therapeutic indication for a B-12 injection is for pernicious anemia, which Mrs. Brock did not have. Vernate was again injected on that date. The Respondent also prescribed Brexin, another amphetamine-family anorexiant; another antibiotic (Erythromycin); Sinequan, an anti-depressant; and refilled Thyrolar, a thyroid medication. On November 15, 1978, Mrs. Brock came to his office complaining of a muscle spasm. At that time she was injected with Aristocort and Vernate. Prescriptions were also given on that date for Soma Compound, an analgesic- muscle relaxant combination. The next visit was January 18, 1979, when the previous medications were re-prescribed. The Respondent made no notes on that visit regarding the patient's complaints and no physical findings were recorded in his notes. The Respondent last saw this patient on January 30, 1979, and injected her with Lincocin, an antibiotic; Aristocort, a cortisone synthetic preparation; and Cofene, another decongestant-antihistamine combination. On that visit she complained of intermittent auxiliary or underarm swollen glands as well as swollen glands in the groin area (lymphnodes), nausea and weakness. Prescriptions for Vectrin, Elavil and Cofene were given on that date. Those are, respectively, antidepressants and an antihistamine decongestant. . . None of these medications were medically indicated for these complaints. The Respondent's records and notes made during this visit and his course of treatment of Mrs. Brock do not reflect an appropriate history, physical findings or amounts of drugs prescribed. Some of the later physical complaints by the patient during her course of treatment, such as nausea and weakness, are actually signs of misuse or overuse of the medications prescribed and yet the Respondent's later prescription practice and treatment of the patient does not reflect consideration of any adverse drug reactions or side effects. Patient, Vassie Johnson, came to the Respondent on November 7, 1977, complaining of a weight problem. The Respondent recorded her weight as 190 pounds and her age as 60 years and made no recordation of her height at that time as it related to her then present weight or her ideal weight. The Respondent prescribed Ionamin and Bacarate, two amphetamine anorexiants. He also prescribed Hygroton, a diuretic; Thyrolar, which is a thyroid hormone; Quibron Plus, a bronchial dilator; Triavil, an antidepressant. The Respondent diagnosed her problems as being chronic, obstructive pulmonary disease; peripheral vascular insufficiency; obesity; and Mitral Valve Prolapse, a disease or condition of the heart. When she came to the Respondent on this first visit, this patient was already taking the following medications: Triavil, an antidepressant; Donnatal, a gastro-intestinal anti-spasmodic; Dyazide, a diuretic; Inderal, an anti-hypertensive drug; Premarin, a female hormone replacement; Nicotinic Acid; and Librax, a gastro-intestinal anti-spasmodic. The patient had indicated on the personal history she supplied the Respondent that she had emphysema, that she had high blood pressure (hypertension), and that she had Mitral Valve disease of the heart. The prescription of amphetamine-family anorexiants are particularly dangerous for someone known to have heart disease and are contraindicated with a patient who has hypertension, as this patient did. This is because the stimulant effects of such drugs speed the heart rate, stress the heart muscle and elevate the blood pressure in someone who already has a problem with elevated blood pressure. Such a course of treatment with a patient such as Mrs. Johnson could have serious adverse health consequences for her, possibly even fatal ones. The standard treatment for obesity with a patient such as Mrs. Johnson is to do a standard medical history, including her diet and exercise history. The practitioner should then establish a program of diet and exercise habit modification appropriate to the patient. The doctor's records do not reflect that this was done with Mrs. Johnson. Catecholamine is a substance produced by cells in the nervous system which acts as a stimulant. Exogenous catecholamines are drugs that have that same effect. They are prescribed for persons with asthma or lung disease, but should not be used with amphetamine-family anorexiants. The Respondent however prescribed two amphetamine-family anorexiants on the same occasion that he prescribed Quibron Plus, a bronchodilator (catecholamines) which is clearly contraindicated in the manufacturer's recommendations. As noted above, amphetamine-family anorexiants can cause heart rhythm problems. On the very next visit, November 28, 1977, Mrs. Johnson complained of chest pain and Dr. Linkous' notation for that visit notes that it is relieved by nitroglycerin. He also notes, in addition to chest pain, that the patient had an occasional extra heart beat or altered heart rhythm. This is a known adverse side effect from the prescription of amphetamine anorexiants. Thus the Respondent, already having a history of the patient's heart problems before prescribing the anorexiants the first time, was supplied additional unequivocal evidence of the patient's heart condition by her complaints of chest pains and altered heart rhythm. In spite of this, on the next visit, on December 5, 1977, the doctor merely prescribed additional medications. Those medications were Hygrotin, a diuretic, P 200 (nature unidentified) ; Bacarate and Ionamin, the same amphetamine-family anorexiants once again. The heart symptoms she experienced at that time are consistent with the known side effects of the prescription of such amphetamine-family medications. Two days after the patient had complained of chest pains and occasional irregular heart beat, November 30, 1977, the Respondent admitted her to Sacred Heart Hospital of Pensacola. His diagnosis at that time consisted of ruling out ischemic myocardial disease, peptic ulcer disease, chronic obstructive pulmonary disease, hyperthyroidism. In his admission summary, the doctor made no record whatever of the medication already prescribed to the patient and which she was at that time taking. He merely indicated in his admission summary the medications the patient was already taking when she first came to him for her first visit. The subsequent office notes during the Respondent's entire course of treatment of this patient do not reflect the course of treatment in the hospital nor that she was ever hospitalized, which is a significant error of omission, as is the failure to record in the hospital admissions summary the medications the patient had been taking and was taking. On December 23, 1977, Mrs. Johnson returned to the Respondent complaining of dysphagia, meaning difficulty in swallowing. The doctor's records don't reflect that any prescriptions were given on that date. She again returned to the Respondent on February 13, 1978, and the doctor's notes indicate that the same medications were continued. In summary, there is no question that the care he provided these three patients was indeed quite dangerous and could or may have been substantially harmful to them. The Respondent has never been charged with a violation of statutory professional practice standards and has never been disciplined with regard to his licensure status.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence in the record and the candor and demeanor of the witnesses, it is, therefore RECOMMENDED: That the Respondent, Dr. Clayton D. Linkous, Jr., be found guilty of violating Subsections 458.1201(1)(m) and (k), Florida Statutes (1977), as substantially reenacted by Subsections 458.331(1)(t) and (h), Florida Statutes, and that his license be suspended for one (1) year, but with that suspension to be stayed and held in abeyance after 45 days of that suspension has been served, and that it be permanently abated after the Respondent demonstrates to the Board that he has successfully completed a continuing medical education course designed to enhance his skills regarding the appropriate use of drugs in medical practice and therapy, appropriate prescription practices and appropriate patient record-keeping and monitoring. DONE and ENTERED this 4th day of June, 1983, in Tallahassee, Florida. P. MICHAEL RUFF, 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 4th day of June, 1983. COPIES FURNISHED: Harold E. Regan, Esquire The Whitehouse - Suite 3 203 North Gadsden Street Tallahassee, Florida 32301 Paul W. Lambert, Esquire 1114 East Park Avenue Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Nonroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION, Petitioner, vs. CASE NO. 81-1631 CLAYTON E. LINKOUS, JR., M.D., License No. 15233 Respondent. /
The Issue The issue to be resolved in this proceeding concerns whether the Respondent is guilty of certain alleged violations of Section 458.331(1)(m), (q), and (t), Florida Statutes, concerning his treatment of one patient during 1984 and 1985 and, if so, what penalty is warranted.
Findings Of Fact The Respondent, Samir Najjar, M.D., is a licensed physician in the State of Florida, having been issued License No. ME0041782. He has been licensed as such at all times pertinent hereto. He received his medical degree from the University of Mexico in 1978. He performed an internship and residency in internal medicine at the Greater Baltimore Medical Center, completing that in 1981. He then completed a fellowship in pulmonary medicine at Wayne State University in Detroit, Michigan, in 1983. He is board certified in internal medicine and holds a Ph.D. in pharmacology and toxicology from Howard University in Washington, D.C. Pharmacology is a specialized field of study in drug pharmacology. It includes the study of chemistry, the effects and uses of drugs, including their toxicology, the origin and nature of drugs, and the pharmacodynamics of drugs. A pharmacologist also studies the effects of drug combinations and their effects on various illnesses and on the body generally. The patient involved in this proceeding is an adult male, who was born on March 4, 1950. He had a long history of reactive, obstructive airway disease, beginning at the age of 17 months to approximately 14 years of age. Between the ages of 14 and 30, the condition alleviated substantially so that he only had very occasional shortness of breath, which could be treated with bronchodilator inhalers. In April of 1980, however, the patient suffered an acute onset of shortness of breath, which condition worsened. He was treated by physicians with a course of Prednisone, an oral steroid medication, for some two to three weeks. This was prior to his being treated by the Respondent. The patient’s condition improved with the Prednisone therapy, but he experienced increasing shortness of breath one to two weeks after terminating that therapy. His shortness of breath become acute, resulting in a respiratory arrest and coma in May of 1980. The patient experienced a hypoxic seizure (lack of oxygen) and was hospitalized at St. Vincent’s Hospital in Jacksonville, Florida, for approximately seven days. Between April of 1980 and July of 1984, he was hospitalized 12 to 15 times for exacerbations of the asthma condition. During this time, he required intubation, or the placing of a breathing tube in the trachea, due to respiratory arrest on three or four occasions, the last one being in December of 1983. The patient has clearly been steroid dependent, with outpatient doses ranging from 5 milligrams four times per day of Prednisone to 35 milligrams twice per day of Medrol through September of 1984. Between July and September of 1984, the patient was receiving 35 milligrams twice per day of Medrol, also an oral steroid. The patient was primarily treated by Edward A. Mizrahi, M.D., between June of 1984 and June of 1985. Dr. Mizrahi is an allergist in Jacksonville, Florida. Prior to that time, he was treated by Irwin Schneider, M.D., a pulmonologist in Jacksonville, Florida. Upon initial presentation to Dr. Mizrahi, the doctor felt that the patient had severe steroid-dependent bronchial asthma with corticosteroid side effects. Patients who have life- threatening asthma are typically treated with anti-inflammatory medications, such as corticosteroids. Severe asthmatics can have life-threatening risks from their condition and will die, on many occasions, without the administration of steroid medications. Thus, such patients must take these medications to survive. Steroids have significant adverse side effects, including “cushinoid features”, development of cataracts and the development of osteoporosis. Despite such adverse side effects, the use of corticosteroids may be necessary in order to simply allow the patient to survive. The subject patient was in such a category. The patient suffered from many of the side effects from long-term steroid use. Dr. Mizrahi noted compression fractures of the spine, cataracts, peptic ulcer disease, and weight gain during his initial evaluation of the patient on June 11, 1984; and on October 10, 1984, noted cushinoid appearance or features. This was before the patient was ever seen or treated by the Respondent. On August 20, 1984, Dr. Mizrahi arranged for the patient to be evaluated at the National Asthma Center (Center) of the National Jewish Hospital and Research Center in Denver, Colorado. This is a specialty facility for the treatment of asthma and is commonly referred to as a “court of last resort”, where pulmonologists refer patients with difficult asthmatic conditions which have not as yet responded satisfactorily to treatment regimens. Between September 12, 1984 and September 16, 1984, the patient was evaluated and treated at the Center. The Center noted the patient’s long history of severe asthma and resultant steroid dependency. Upon initial evaluation, the physicians at the Center felt that the patient would probably require continuing steroid therapy, but they did attempt to reduce the steroid dosage. The attempt to reduce the steroid dosage in the patient was unsuccessful, and the Center ultimately had to increase the steroid dosage. The patient was discharged from the Center on an oral steroid medication, Medrol, 20 milligrams, alternating with 40 milligrams, four times per day. This is considered a high dose of steroid medication and was reluctantly arrived at and prescribed by the physicians at the Center after they made bona fide attempts to wean the patient from steroids to the extent possible. During his hospitalization, the physicians at the Center noted that the patient gave a “convincing history for ischemic heart disease”. They suggested an investigation to determine the presence of this condition. Upon the patient’s return to Jacksonville, Florida, he continued to be treated by Dr. Mizrahi and continued to receive oral steroid medication in high doses. Additionally, he was receiving Halcion, Adivan, Fiorinal, and Fastin. The Respondent first saw the patient on June 13, 1985 upon a referral from Dr. Samara, a urologist in Jacksonville, Florida, who had some contact with the patient. The Respondent took an extensive history from the patient, including a list of the current medications he was receiving from Dr. Mizrahi, which then included Medrol, 24 milligrams, four times per day, with a bolus of Medrol as needed of 60 milligrams four times per day for 48 hours, followed by 30 milligrams four times per day for two weeks. The patient was also receiving Halcion at 0.25 milligrams at bedtime and Adivan at 2 milligrams. The Respondent had the impression that the patient suffered from asthma and possibly from coronary artery disease. Due to the possibility of coronary artery disease, which had been raised during the admission at the Center, the Respondent hospitalized the patient from June 17, 1985 to June 22, 1985 at St. Vincent’s Medical Center in Jacksonville, Florida, to investigate the coronary situation. During this hospitalization, an extensive history and physical were performed, including a neurological examination of the patient. A cardiac workup was performed by consulting cardiologist, Joel Ferree, M.D. This included a cardiac catheterization performed by Dr. Ferree, which indicated that the patient had normal right ventricular function, no significant arteriosclerotic lesions, and no significant artery response to adrenergic agonist agents. The cardiac catheterization reported normal left ventricular function. The cardiac catheterization report ruled out any cardiomyopathy. During this hospitalization, the Respondent also ordered x-rays of the cervical and thoracic spine. The x-rays revealed “mild, old compression deformities of the eighth and ninth thoracic vertebral bodies, with no change since a previous examination on November 30, 1983”. This x-ray report was consistent with the previously- reported compression deformities, or compression fractures, which are the result of osteoporosis. Osteoporosis leaves the bones weak, with loss of trabeculation. The patient’s vertebra were already being crushed as of June of 1985, when the Respondent undertook his care. At the time of discharge from this hospitalization, the Respondent recorded that he would like to wean the patient off steroids over several months. The Respondent continued to treat the patient through April of 1989. During this period of time, the asthma was reasonably controlled with the use of steroid medications and bronchodilaters. Unlike the previous few years, the patient only required hospitalization for treatment of exacerbation of asthma symptoms on one occasion, on November 7, 1985. During this period of treatment, he never had a respiratory arrest and intubation was never required. The Respondent would wean the patient from the use of steroids during this period of treatment when the symptoms allowed. When the symptoms were exacerbated, he would provide prescriptions for corticosteroids so as to address the patient’s condition. The Respondent made numerous attempts to wean the patient off high-dose steroid medication, but the patient’s condition would not permit a cessation of it. The fact that the Respondent was unable to wean the patient from steroids is not surprising to physicians who treat such a condition. It is not a deviation from the accepted standard of care. The patient had a very significant case of asthma, which was life threatening, as demonstrated by the records of not only the Respondent, but the prior treating physicians. His asthma was so significant that he had to receive steroid medication, despite the significant side effects caused by such medication, in order to insure survival. During the course of treatment, the Respondent also treated the patient for cervical strain and low-back pain. His compression fractures were a source of great pain, justifying the prescription of narcotic analgesics. The Respondent’s treatment for these conditions included physical therapy, paralumbar trigger point injections, biofeedback, TENS Unit, ice packs, as well as drugs, including muscle relaxants and analgesics. The Respondent also referred the patient for examination by orthopedic physicians and neurologists. These efforts were appropriate and within the standard of care. The prescriptions for Flexeril, Fiorinal, Lortab and Tylox and other medications for the control of back pain and muscle spasms were appropriate and under the circumstances of this severely-distressed patient, were within the standard of care. The Respondent, on occasion, prescribed medications for control of insomnia, including Halcion. These same medications had previously been prescribed for the patient by Dr. Mizrahi for the same condition and were appropriate prescriptions. The corticosteroids and other medications used to control asthma can produce a side effect of insomnia. This manifestation must be treated for the benefit of the patient. The prescriptions for Halcion were appropriate and within the standard of care. An additional side effect of steroid medication is weight gain. The Respondent advised the patient regarding dietary control for his weight to alleviate such a problem. The patient, however, exhibited substantial weight gain. Therefore, the Respondent prescribed a limited amount of Fastin, an appetite suppressant. Physicians must use medications such as Fastin with caution on patients with significant hypertension. The patient’s blood pressure, however, was not significantly elevated; and his blood pressure was being monitored during his use of Fastin. The use of Fastin by this patient did not cause a significant increase in his blood pressure. Fastin is a sympathomimetic amine. It is not a true amphetamine. It is appropriately prescribed for weight control and this patient had exhibited an increase in weight, doubtless due to a side effect of the steroid medications. Increased weight in the patient was medically significant because he already had compression fractures of his vertebrae caused, no doubt, by osteoporosis, also attributable to side effects of steroid medications. Increased weight could exacerbate his skeletal problem and cause additional pain. Increased weight is also dangerous for patients with asthma, in any event, because it severely taxes the respiratory system and can make intubation, if necessary, more difficult. The Respondent’s prescriptions for Fastin were shown to be appropriate and within the standard of care, as demonstrated by the expert testimony of Dr. Miller and the other testimony in evidence offered by the Respondent. During treatment of the patient, the Respondent prescribed Adivan also. Adivan is a muscle relaxing drug, and it was shown to be appropriately within the standard of care for physicians confronted with a patient with the multiple problems exhibited by this one. Although there can be some concern about mood alteration under certain circumstances with the use of Adivan and perhaps to some extent with Halcion, the Respondent did perform mental status examinations and referred the patient for evaluation when indicated. During his treatment of the patient, there was never any symptom of suicidal ideation expressed by the patient. There was no reason demonstrated which would justify the referral of the patient to a psychiatrist at an earlier date in the subject situation. The testimony of Dr. Miller and the other experts adduced by the Respondent shows that under the peculiar circumstances of this patient, the use of Adivan, as well as Halcion, in conjunction with the other medications the patient was taking, was medically justified and within the appropriate standard of care. It has been demonstrated that the medical records maintained by the Respondent justify the course of treatment of the patient, as shown by testimony of record at pages 105 and 106 of the transcript of the proceedings and Respondent’s Exhibit 1 at pages 52-54. The Respondent practiced with that level of care, skill and treatment recognized as appropriate to meet the standard of care for similar physicians. Upon weighing the expert testimony adduced by the parties, it is determined that the expert testimony presented by the Respondent was more persuasive and creditable than that presented by the Petitioner. The Petitioner’s expert, Dr. Kreitzer, relied upon some flawed information in developing his expert opinions, including, but not limited to, his reliance upon compilations of prescription information which was not established as accurate in the course of this proceeding, being merely computer printouts from records of pharmacists. Those records do not, for instance, even show that the Respondent prescribed all of those medications represented thereon. Dr. Kreitzer’s opinion was also flawed because his belief was based, in part, on his understanding that the patient was suffering from cardiomyopathy, when that condition had already been ruled out by cardiac tests performed upon the Respondent’s order during the June of 1985 hospitalization. Dr. Kreitzer’s mistaken belief that Fastin is an amphetamine, which it is not, also detracts from the weight which can be ascribed to his opinion. Further, Dr. Groble, the other expert presented by the Petitioner, cannot be relied upon because in his testimony he admits that he cannot render an opinion that the Respondent departed from appropriate standards of care in his practice with regard to the subject patient in the instances alleged in the Administrative Complaint because he had not seen all of the Respondent’s pertinent medical records. Consequently, he could not render a definitive opinion, one way or the other. The Respondent’s expert witnesses, Dr. Miller and Dr. Sharpe, are accepted as more credible than the Petitioner’s expert testimony. Both Drs. Miller and Sharpe indicated that they had reviewed, in some depth, the medical records which the Respondent maintained concerning the patient and those records and the history pertaining to treatment rendered by other physicians and the Center. Their testimony revealed an in-depth study, reflection and consideration of the concededly large doses of multiple medications, some of which have significant side effects. They regrettably agree, that confronted with a complex, life-threatened patient, such as this, the Respondent could have done little else than follow the course of treatment and medication pattern and practice which he followed. While these experts and the Respondent, in the course of treatment, recognized the risks attendant to the engendering of dependency on the steroids and the use of the other medications, they acknowledged that under the circumstances there was little else that could be done in order to keep the patient stable, accord him some quality of life, and even to save his life. In summary, it has not been established that the Respondent failed to adequately keep written medical records which justify the course of treatment of the patient. It has not been established that the Respondent prescribed legend drugs, including controlled substances, other than in the course of his professional practice, nor has it been established that he prescribed legend drugs in excessive quantities and in excessive combinations or, otherwise, inappropriately in relation to generally-accepted medical practice. It has not been established that the Respondent failed to practice medicine with that level of care, skill and treatment recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered by the Board of Medicine dismissing the Administrative Complaint in its entirety.DONE AND ENTERED this 5th day of February, 1997, in Tallahassee, Florida. P. MICHAEL RUFF Administrative Law Judge Division of Administrative Hearings 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 Hearings this 5th day of February, 1997. COPIES FURNISHED: Albert Peacock, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Bruce D. Lamb, Esquire SHEAR, NEWMAN, ET AL. Post Office Box 2378 Tampa, Florida 33602 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403
The Issue Whether Dr. Henson inappropriately administered repeated injections of vitamin B-12 to his patient, Gertrude Ashton, without documenting their necessity in the patient's medical records? Whether Dr. Henson inappropriately administered repeated injections of steroids to his patient, Gertrude Ashton, without documenting their necessity in the patient's medical records? Whether Dr. Henson inappropriately administered repeated injections of Mandol to his patient, Gertrude Ashton, which were not considered to be therapeutically effective?
Findings Of Fact The parties stipulated to the following findings of fact: The Respondent, D. Ross Henson, D.O., is currently, and at all times relevant to this proceeding was, licensed as an osteopathic physician in the State of Florida; Dr. Henson's license number is OS 0001793; Between December 1979, and September 1983, Dr. Henson treated a patient by the name of Gertrude Ashton. Ms. Ashton's husband died in 1981. Ms. Ashton witnessed Mr. Ashton's death in the back yard of their residence. Mr. Ashton's death caused Ms. Ashton anxiety and depression. Ms. Ashton's business had some financial problems during the period at issue in this case. During the approximately forty-six months at issue in this proceeding, Dr. Henson treated Ms. Ashton on sixty occasions. During this period of time Dr. Henson prescribed 2,000 micrograms of vitamin B-12, to be administered intramuscularly, for Ms. Ashton. Ms. Ashton received injections of vitamin B-12 on sixteen separate occasions from Dr. Henson. When Dr. Henson prescribed vitamin B-12 injections for Ms. Ashton, he documented the various problems which she was having at the time in her medical records. Dr. Henson indicated that the reasons for the injections were that Ms. Ashton was under stress, she had long-standing, ongoing disease processes which produced further stress, she was on antibiotics and she was receiving diuretic therapy. Additionally, on occasion, Ms. Ashton requested vitamin B-12 injections. Generally, vitamin B-12 should be administered intramuscularly only if a patient is suffering from vitamin B-12 deficiency. A vitamin B-12 deficiency may be caused by pernicious anemia or malabsorption of vitamin B-12. If a physician suspects that a patient is suffering from vitamin B-12 deficiency, a simple blood test should be administered to determine if the patient's vitamin B-12 level is low. If it is, the physician should then attempt to determine the cause of the deficiency. Dr. Henson did not determine whether Ms. Ashton was suffering from a vitamin B-12 deficiency. Occasionally vitamin B-12 may be administered to a patient who believes that the vitamin will help him or her feel better. Although vitamin B-12 is included as part of nutritional supplements, it is not taken intramuscularly as a nutritional supplement. If a patient is in need of vitamin B-12, 1,000 micrograms is a sufficient dosage. An injection of 2,000 micrograms of vitamin B-12 is excessive. It would be difficult to harm a patient by injecting the patient with vitamin B-12. The reasons for administering vitamin B-12 injections to Ms. Ashton advanced by Dr. Henson and Dr. Henson's medical records fail to justify all of the vitamin B-12 shots administered to Ms. Ashton. Nowhere in Dr. Henson's records concerning Ms. Ashton is it indicated that Ms. Ashton suffered from a vitamin B-12 deficiency. Nor is any other adequate reason for administering the shots she received indicated. It is true that a few of the vitamin B-12 shots prescribed by Dr. Henson for Ms. Ashton may have been requested by Ms. Ashton because she believed they would help her. Not all of the sixteen shots were requested by Ms. Ashton, however. Nor would all sixteen shots be justified by such a request had it been made. Prescribing 2,000 micrograms of vitamin B-12 for Ms. Ashton was also not justified. The repeated injections of 2,000 micrograms of vitamin B-12 administered to Ms. Ashton were a deviation from the accepted standard of care. Dr. Henson also prescribed 34 intramuscular injections of steroids for Ms. Ashton over the 46 months at issue in this proceeding. Dr. Henson injected Ms. Ashton with methylprednisolone acetate, a form of injectable steroid. The brand name of the methylprednisolone acetate used by Dr. Henson was Depo-Medrol. The 34 injections of methylprednisolone acetate were given in doses of fifty milligrams. Methylprednisolone acetate should be given in doses of twenty to eighty milligrams per injection. Prednisolone tebutate, another form of injectable steroid, should be given in doses of four to forty milligrams. Dr. Henson did not, however, give Ms. Ashton prednisolone tebutate. Dr. Henson noted in his medical records concerning Ms. Ashton that he had given her an injection of "Pred." Identifying the injections as "Pred" was insufficient to inform others of how Ms. Ashton was treated with steroids. Dr. Henson indicated that he gave Ms. Ashton steroid injections for the following problems: Acute synovitis and osteoarthritis of the lumbar and cervical spine, acute contact dermatitis, acute allergic rhinitis and acute polyposis. Steroids can be used to treat bursitis and tendinitis. Usually, an injection of steroids for this type of treatment is administered locally. Ms. Ashton's acute contact dermatitis was attributable to her repeated contact with poison ivy and the use of undiluted bleach which Ms. Ashton bathed in as a treatment of her poison ivy. Ms. Ashton also inhaled the fumes from the bleach. Occasional injections of steroids for the treatment of poison ivy, especially when the area affected has been bathed in undiluted bleach, is appropriate. The weight of the evidence concerning Dr. Henson's treatment of Ms. Ashton with steroids proved that generally, most physicians would have administered the injections locally or orally. The evidence did not prove that Dr. Henson's treatment of Ms. Ashton with steroids was not within acceptable standards of care. Dr. Henson also prescribed three injections of Mandol for Ms. Ashton over the 46 months at issue in this proceeding. Injections of Mandol were administered on March 13, 1980 and November 13 and 16, 1981. The injections of Mandol administered to Ms. Ashton were in doses of 250 milligrams. The recommended dose of Mandol is from 500 milligrams to one gram. A dose of 250 milligrams is sub-therapeutic. Mandol is a cephalosporin, which is a form of antibiotic. The March 13, 1980, injection of Mandol was given for acute bronchitis, acute pyelonephritis and acute cystitis. Ms. Ashton was also taking Ceclor, another cephalosporin, orally at the time the injection of Mandol was given. The November 13 and 16, 1981, injections of Mandol were given for acute bronchitis and acute generalized dermatitis due to poison ivy and exposure to bleach. Ms. Ashton was taking another cephalosporin orally at the time the injections of Mandol were given. If a lower dose of Mandol would be effective, it would be listed by the drug manufacturer as a recommended dose. Although there are possible side effects from treatments with Mandol, Dr. Henson did not establish that those side effects were present in Ms. Ashton's case. Dr. Henson's treatment of Ms. Ashton with Mandol during the period of time at issue in this proceeding deviated from the standard of medical care reasonably acceptable under similar conditions and circumstances. Ms. Ashton subsequently filed a complaint concerning Dr. Henson with the Department. The Department investigated the complaint and found probable cause to formally charge Dr. Henson.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Dr. Henson be found guilty of failing to keep written medical records justifying his treatment of Ms. Ashton with injections of vitamin B-12, steroids and Mandol between December 1979, and September 1983. A fine of $500.00 should be imposed on Dr. Henson for his treatment of Ms. Ashton with excessive doses of vitamin B-12; a fine of $500.00 should be imposed on Dr. Henson for his failure to adequately document the type of steroid administered to Ms. Ashton; and a fine of $500.00 should be imposed on Dr. Henson for his treatment of Ms. Ashton with sub-therapeutic doses of Mandol. Dr. Henson should also receive a reprimand for these three violations of Section 459.015(1)(p), Florida Statutes (1987) It is further RECOMMENDED that Dr. Henson be found guilty of failing to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances with regard to his treatment of Ms. Ashton with injections of vitamin B-12 and Mandol between December 1979, and September 1983. Dr. Henson should be fined $1,000.00 for his violations of Section 459.015(1)(y), Florida Statutes (1987), placed on probation for ninety (90) days and required to successfully complete ten (10) hours of Category I continuing medical education in prescribing controlled substances during the twelve months following the issuance of a final order in this case. It is further RECOMMENDED that the charge that Dr. Henson's treatment of Ms. Ashton with steroids between December 1979, and September 1983, constitutes a violation of Section 459.015(1)(y), Florida Statutes (1987), be dismissed. It is further RECOMMENDED that the charge that Dr. Henson's treatment of Ms. Ashton with vitamin B-12, steroids and Mandol between December, 1979, and September, 1983, constitutes a violation of Section 459.015(1)(u), Florida Statutes (1987), be dismissed. DONE and ENTERED this 24th day of June, 1988, in Tallahassee, Florida. LARRY J. SARTIN 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 day of June, 1988. APPENDIX Case Number 86-3336 The parties have submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. The Department's Proposed Findings of Fact Proposed Finding Paragraph Number in Recommended Order of Fact Number of Acceptance or Reason for Rejection 1-2 1. 3-6 Hereby accepted. 7 4. 8 15-16. 9 19. 10 25-26. 11-13 Not relevant to the charges contained in the Administrative Complaint against Dr. Henson in this case. 14 2. 15-25 & 27 Not relevant to the charges contained in the Administrative Complaint against Dr. Henson in this case. 26 33. Dr. Henson's Proposed Findings of Fact Proposed Finding Paragraph Number Recommended Order of Fact Number of Acceptance or Reason for Rejection 1-2 1. 3 Not relevant to this case. 4 2-3. 5 Not relevant to this case or not supported by the weight of the evidence. 6 4-5. 7 5. 8 4-5. 9 Summary of testimony and events which took place during the formal hearing. The facts this testimony supports were not supported by the weight of the evidence. 10 15-19. 11 20. 12-13 22. Not relevant to this case. Summary of testimony. The facts this testimony supports were not supported by the weight of the evidence. 16 25 and 28. 17 26 and 28. The last three sentences are not supported by the weight of the evidence. 18 29. 19 Summary of testimony. The facts this testimony supports were not supported by the weight of the evidence. COPIES FURNISHED: Theodore Doran, Esquire James J. Kearn, Esquire DOPAN & DANIELS, P.A. P. O. Drawer 1231 Daytona Beach, Florida 32015 James W. Smith, Esquire Kim D. Bouck, Esquire SMITH, SCHODER & ROUSE, P.A. 605 S. Ridgewood Avenue Daytona, Florida 32014 Rod Presnell Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Lee Sims Staff Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================
