Findings Of Fact Respondent is a chiropractic physician licensed in the State of Florida, having been issued license No. 0001050. Respondent's office is located at 920 North Federal Highway, Hollywood, Florida. On July 31, 1980, Evelyn Yaxley, an elderly resident of Hollywood, was initially seen as a patient by Respondent. During that first visit, Respondent took a patient history, performed an examination, and administered a complete blood count and a urine test. He also dispensed to Mrs. Yaxley a bottle of Baldrian, a natural muscle relaxant, together with some vitamins. Respondent also performed an adjustment to Mrs. Yaxley's coccyx. At the end of the visit, Mrs. Yaxley was given a bill for $102.00 for Respondent's services, which she and her husband paid before leaving the office. On August 5, 1980, Mrs. Yaxley returned to Respondent for her next scheduled appointment, and was again accompanied by her husband. During the visit, Respondent informed Mrs. Yaxley that she had a urinary tract infection, which Respondent diagnosed partially from the laboratory test results obtained from the urine test taken on her previous visit. During the second visit, Mrs. Yaxley was taken into a treatment room where Respondent administered another adjustment. Dr. Kahn then left the treatment room and, in the presence of the patient's husband, instructed a receptionist who worked in his office to give Mrs. Yaxley four Azo Gantrisin tablets. The receptionist then entered the treatment room and gave four Azo Gantrisin tablets to Mrs. Yaxley, which Mrs. Yaxley took. At some point attendant to the administration of the Azo Gantrisin tablets, the Yaxleys questioned the Respondent about the advisability of administering Azo Gantrisin inasmuch as Mrs. Yaxley was sensitive to "sulfa drugs." The Yaxleys were assured, however, by Dr. Kahn that though the tablets were a sulfa drug derivative, they would be safe for her to take. The Yaxleys were then given, at Respondent's direction, a bottle of Azo Gantrisin tablets and instructed to have Mrs. Yaxley take two tablets every four hours. The Yaxleys paid Respondent $40.00 for his services rendered during the second visit. Azo Gantrisin is a product of two chemical entities, Phenaxopyridine and Sulfisoxazole, and is commonly referred to as a "sulfa drug." The drug is prescribed for treatment of urinary tract infections. Azo Gantrisin can cause adverse drug reactions, which are defined as any unintended or unexpected noxious effects that alter the structure or function of the body. Adverse drug reactions include allergic reactions, such as scratching, itching, swelling, and rashes. Other adverse drug reactions include swelling of the skin, difficulty in breathing, nausea, and vomiting. After the Yaxleys' visit to Respondent's office on August 5, 1980, they returned home, and later that same day Mrs. Yaxley took an additional dosage of Azo Gantrisin tablets in accordance with Respondent's instructions. Shortly thereafter, she became ill, experiencing severe nausea and vomiting. These symptoms continued throughout the night and into the next day. On the morning of August 6, 1980, Mrs. Yaxley was treated by her family physician for these symptoms, and was ultimately admitted to the hospital, where she remained for a period of approximately eight days. Mrs. Yaxley reported to both her family physician and hospital physicians that she had been given Azo Gantrisin tablets by a chiropractic physician and had taken them in the dosages reflected hereinabove. She also reported to hospital physicians, as she had indicated to Respondent earlier, that she was allergic to sulfa drugs. However, despite the similarities of the symptoms reported by Mrs. Yaxley to those which indicate an adverse reaction to sulfa drugs, tests run while she was hospitalized are inconclusive on the question of whether she in fact suffered such a reaction. These tests neither confirm nor rule out such an adverse reaction. Azo Gantrisin is a legend drug required to be dispensed or administered only by a physician. A chiropractic physician is expressly prohibited from administering or dispensing any legend medicine or drug. Respondent has never had an administrative complaint filed against him by the Department of Professional Regulation or the Board of Chiropractic prior to the instant Administrative Complaint.
Findings Of Fact The parties stipulated that Monroe C. Schiffman is a pharmacist licensed by the Florida Board of Pharmacy. They further stipulated that Sharon Drugs, Inc. d/b/a Mercy Professional Building Pharmacy is located at 3661 South Miami Avenue, Miami, Florida and that Sharon Drugs, Inc. owns and operates Mercy Professional Building Pharmacy. The parties also stipulated that Monroe C. Schiffman was a corporate officer and share holder in Sharon Drugs, Inc., a Florida corporation, from March, 1974 until the audits in question. An inspection and audit of Monroe Drugs, Inc. d/b/a Morris Drugs and Monroe Schiffman and Sharon Schiffman, was begun on May 5, 1976 and lasted several days. The audited period was from July 1, 1974 until May 5, 1976 during which dates Monroe C. Schiffman was a corporate officer and stockholder in Morris Drugs, Inc. The procedures for the audits were to assume a zero stockage as of July 1, 1974 and to account for the drugs received after that date. The drugs audited were controlled drugs as defined by Chapter 893, Florida Statutes. These drugs were chosen for audit because complete records of their order, receipt and dispensing must be kept pursuant to Chapter 893, Florida Statutes. Exhibit 2, a summary of the audit of Morris Drugs, Inc., was identified by the Board's agent, Vernon K. Bell, as the summary of the discrepancies in controlled drugs revealed by the audit which he conducted. The audit conducted by Vernon K. Bell revealed a shortage of controlled drugs for which no records had been kept of 157,569 total units or pills. The drugs audited were Desoxyn (methamphetamine hydrochloride), Percodan (Oxycodone hydrochloride), Quaalude (methaqualone), Biphetamine (d- and dl-Amphetamine), Eskatrol Spansule (dextroamphetamine sulfate and prochlorperazine), Tuinal (sodium amobarbital and sodium secobarbital), Seconal (sodium secobarbital), Dexedrine (dextroamphetaimine sulfate), Nembutal (sodium pentobarbital), Dilaudid (hydromorphone), Amytal (amobarbital), and Dexamyl (dextroamphetamine sulfate). The records required to be kept by law of the dispensing of controlled drugs were not kept by the permittee, Monroe Pharmacy, Inc. d/b/a Morris Drugs and Monroe Schiffman and Sharon Schiffman.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the permit of Monroe Pharmacy, Inc. d/b/a Morris Drugs and Monroe Schiffman and Sharon Schiffman be revoked. DONE and ORDERED this 5th day of January, 1977 in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings Room 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Michael Schwartz, Esquire Suite 201 Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 Gerald Kogan, Esquire Suite 500 Security Trust Building 700 Brickell Avenue Miami, Florida 33131 H. F. Bevis, Executive Secretary State Board of Pharmacy 252 East Sixth Avenue Box 3355 Tallahassee, Florida 32303
The Issue Whether CFSATC, Inc. (Petitioner), should be selected as the service provider instead of Metro Treatment of Florida, L.P. (Metro/Intervenor), to meet the need of an additional outpatient methadone maintenance program in the Department of Children and Family Services (DCF), District 7 (Osceola County).
Findings Of Fact The Department of Children and Family Services (DCF/Respondent) notified Petitioner by letter dated May 28, 1999, that DCF had selected another applicant to be the service provider to meet the determined need of one additional outpatient methadone maintenance program in DCF, District 7. As an applicant to be a service provider, Petitioner's interests are substantially affected by Respondent's action. Respondent also notified Intervenor by letter dated May 28, 1999, that Metro had been selected by DCF to be the service provider to meet the determined need of one additional outpatient methadone maintenance program in District 7, as published by Respondent in the Florida Administrative Weekly. On June 18, 1999, Petitioner timely filed a Petition challenging Respondent's action on May 28, 1999, in "denying its license" with Respondent. On July 7, 1999, Petitioner filed an Amended Petition with DCF which not only challenged Respondent's action in "denying" Petitioner's license, but also challenged Respondent's May 28, 1999, action in "awarding a license" to Metro. On or about August 10, 1999, Metro filed a Motion to Intervene in the instant proceeding which was granted. Intervenor's interests in being selected as the service provider to meet the determined need of an additional outpatient methadone maintenance program in DCF, District 7, as published by Respondent are substantially affected by the Petition seeking to challenge Respondent's action, or request that DCF issue a second license. Determination of Need The intent of Chapter 397, Florida Statutes, as it relates to methadone licenses is to control the growth of methadone programs. Under the statute and rules, DCF is required to complete an annual heroin and methadone treatment needs assessment survey no later than October 1, and publish the results of the survey no later than the following January 1. Respondent failed to complete a needs assessment survey in 1998. In 1999, Respondent, as the State Methadone Authority, conducted a needs assessment for methadone providers by collecting information on four different criteria delineated in Rule 65D-16.014(1)(c)1.c., Florida Administrative Code, including arrest data from the Florida Department of Law Enforcement and information on travel hardship from the local district offices of DCF. The data was compiled into a report which concluded that "a need has been established in Districts 7 and 11," but not in any other district. It is Respondent's responsibility, as the State Methadone Authority, to review the needs assessment data and/or report and to interpret the data, and make a determination as to the number of new medication treatment service providers needed in each district. Respondent determined that there is a need for one additional methadone medication treatment service provider in Osceola County. Respondent's determination of need for only one additional outpatient methadone treatment provider in Osceola County is consistent with past DCF practices of limiting the expansion of medication treatment programs to a single facility at a time. On April 9, 1999, Respondent published a statement of findings in the Florida Administrative Weekly, identifying Respondent's determination of need for the state. The statement which provided as follows: Pursuant to section 397.427, Florida Statutes, and administrative rules adopted thereunder, the Department of Children and Family Services has conducted a survey to determine the need for new medication (methadone) treatment service providers. The survey results are provided by the Department of Children and Family Services District Offices as follows: District 7 and 11 The need for one additional outpatient methadone maintenance program has been established for each of these districts. Prospective applicants for a license to operate an outpatient methadone maintenance program in Districts 7 and 11 may direct requests for an application to the following: District 7-Department of Children and Family Services Alcohol, Drug Abuse, and Mental Health Program Office, 400 West Robinson Street, Hurston Building, South Tower, Suite S-430, Orlando, Florida 32801, Attention: Glen Casel. District 11-Department of Children and Family Services, Adult Care Division, 401 N.W. 2nd Avenue, Room 812, North Tower Miami, Florida 33128, Attention: David Raymond. Districts 1, 2, 3, 4, 5, 6, 8, 9, 10, 12, 13, 14 and 15. The need for additional medication (methadone) services has not been established in these districts. Copies of the assessment report may be obtained from: Department of Children and Family Services, Substance Abuse Program Office, 1317 Winewood Boulevard Building 3, Room 105-I, Tallahassee, Florida 32399-0700. Respondent published a correction to its April 9, 1999, publication on April 30, 1999, in the Florida Administrative Weekly. The April 30, 1999, publication was identical to the April 9, 1999, publication except that it provided for a May 14, 1999, deadline for submitting applications to Districts 7 and 11. No administrative petitions or challenges were filed with Respondent challenging its determination of need for "one additional outpatient methadone maintenance program" for Osceola County. Petitioner filed an application to be a new service provider for District 7 with DCF dated April 14, 1999. The application did not contain a physical address for the proposed clinic. Respondent informed Petitioner verbally and in writing that in order for the application to be considered it would have to provide a physical location or address. In addition, it would have "to provide a fire inspection, evidence of zoning approval, occupational licenses and originally, also a health inspection of the property, which was after the fact." Petitioner secured a physical location and submitted a supplement to its application on May 10, 1999. The fire inspection submitted by Petitioner for the proposed facility showed that it had code violations which would need to be corrected before Respondent could issue a license. Intervenor's original application was sent by Federal Express, standard overnight delivery, on May 13, 1999, addressed to Glen Casel, Florida Department of Children and Family Services, 400 West Robinson Street, Suite 1129, Orlando, Florida. According to the published notice in the Florida Administrative Weekly, prospective applicants for a license to operate an outpatient methadone maintenance program in Districts 7 and 11 are instructed to "direct requests for an application" to District 7, Department of Children and Family Services, Alcohol, Drug Abuse, and Mental Health Program Office, 400 West Robinson Street, Hurston Building, South Tower, Suite S-430, Orlando, Florida 32801, Attention: Glen Casel. The notice does not state a specific address where the application must be filed. Suite 1129 is the District Administrator's Office for DCF, District 7. Respondent sought to verify, prior to reviewing the applications, that Intervenor's application was received by DCF on May 14, 1999. The evidence presented at hearing was sufficient to indicate that Metro's application was received by Respondent on May 14, 1999. In response to DCF's April 9, 1999, and/or April 30, 1999, publication in the Florida Administrative Weekly, Respondent received two timely-filed applications for license to operate one additional methadone outpatient clinic in District 7. One application from Petitioner and one application from Intervenor. The number of responses to Respondent's April 9, 1999, and/or April 30, 1999, published notice of need exceeded the determined need for "one additional outpatient methadone maintenance program" for District 7. When the number of applications exceeds the need determined by DCF, Respondent views the application process as a two-step process. First, Respondent reviews the applications pursuant to Rule 65D-16.014(1)(c)1.c., Florida Administrative Code, to select a service provider based on "organizational capability" to implement DCF's rules; and second, the applicant selected must then come into compliance with all the license requirements of Section 397.403, Florida Statutes, to obtain a permanent license. In looking at the "organizational capability" of the applicants, Respondent rates the applicants based on their ability to implement the required provisions of the administrative rule. It is Respondent's interpretation of both its statute and administrative rules that fire inspections, zoning approval, safety inspection, and occupational licenses need to be in place prior to Respondent's issuing a permanent license to a service provider, but do not necessarily have to be in place prior to evaluating competing applications when the number of applications exceeds the need determined by Respondent. Both applications were evaluated by Respondent pursuant to the rule, for selection of the service provider. In its initial evaluation of two application, Respondent determined that Metro's written policies and procedures demonstrate that its "organizational capability . . . to properly implement the appropriate federal and state methadone regulations" exceeds the organizational capability of Petitioner. Petitioner's Organizational Capability Carol Ball testified that she was the executive director and program sponsor for Petitioner. Ball is not a licensed health professional. She understood that pursuant to Rule 65D-16.014(2)(a), Florida Administrative Code, defining "program sponsor," she could substitute five years' experience in the field of addictions in lieu of being a licensed health professional. Respondent testified that in order to be a program sponsor for a methadone service provider, a person had to be a licensed health professional and have five years experience in the field of addictions. Therefore, Ball did not qualify as "program sponsor." Ball was then recalled as a witness and testified that she was only the program sponsor for purposes of the FDA, not the State of Florida. Ball's testimony that she was not the program sponsor for Petitioner is not credible. Petitioner presented no evidence as to the identity of a program sponsor other than Ball. Petitioner's application failed to include letters of reference or a statement of educational level or work experience for its program sponsor as required by the rules. Dr. Juan Perez Boudet, who is identified in Petitioner's application as the medical director, is a physician licensed by the State of Florida and has worked in the field of addictions for at least 15 years. Petitioner's application did not include résumés or background information for any of its staff. The rules require that an applicant submit written policies and procedures with the application. Petitioner failed to submit any written policies and procedures as part of its original application. Petitioner testified that it did not provide résumés, background information, and written policies and procedures as part of its original application as required by the rules because the information "was not requested by the Department." The person responsible for regulatory and licensing issues for Petitioner testified that she did not review the applicable administrative rules prior to submitting the application. Petitioner submitted an undated policies and procedures manual into evidence at the hearing but presented no testimony about such policies and procedures. Petitioner's policies and procedures manual consists of approximately 200 pages, 50 percent of which are blank FDA and state forms. Petitioner's policies and procedures manual indicates that the manual submitted by Petitioner at the hearing has not been recently updated. Petitioner displayed a lack of knowledge of the requirements of Chapter 65D-16, Florida Administrative Code, and Chapter 397, Florida Statutes, specifically as it relates to the application process. It repeatedly faulted Respondent for any shortcomings in Petitioner's application. Metro's Organizational Capability Dr. Randall B. Greene is identified in both Intervenor's original application filed with DCF on May 14, 1999, and the updated application, tendered into evidence at the hearing, as both the program sponsor and executive medical director for Metro Treatment of Florida, L.P., d/b/a Mid Florida Metro Treatment Center. Dr. Randall B. Greene is a doctor of osteopathy licensed by the State of Florida, License No. OS-0004037. Dr. Greene operated eight methadone clinics in several states, including Florida, from 1985 to 1997, when he sold the clinics to the parent company of Metro. Dr. Greene is currently under a management agreement with Colonial Management Group, L.P., which owns and manages Metro. Under the terms of the management agreement, Dr. Greene's duties include establishing new methadone clinics, formulating policies and procedures that relate to medical practice, and ensure the operation of the methadone clinics from a medical perspective, and complies with federal and state rules and regulations. Dr. Greene exhibited an in-depth knowledge as to the operation of Metro's clinics in each city, as well as staffing patterns. Dr. Greene has been working in the field of addiction in excess of five years as required by the rules. Dr. Greene, as executive medical director of Metro, oversees all medical services provided by Metro's clinics, as well as the licensed physician/medical director for each clinic. Dr. Green's responsibilities are described in Metro's policies and procedures manual as required by the rules. Metro's original application, as well as its updated application, include a résumé for Dr. Greene which sets forth his educational level and work experience, and a letter of recommendation from Dr. Greene's former employer as required. Dr. Greene prepared Metro's application currently at issue. Peter Santostefano is the chief executive officer of Metro and its parent company, Colonial Management Group, L.P. The CEO retains overall administrative responsibility and authority in all center or program matters. William Sheridan is the Vice President of Operations for Colonial Management Group, L.P., a Delaware limited partnership which is authorized to do business in Florida, which owns and manages Metro. It owns and operates eight methadone treatment centers in Florida. He currently supervises five regional directors who supervise 30 methadone programs nationwide. Sheridan holds a Bachelors degree in criminal justice, a masters degree in counseling and is certified as an addictions specialist by the American Academy. Prior to assuming the position of Vice President of Operations for Colonial Management, Sheridan worked directly for Dr. Greene holding positions as a case manager for the Daytona Methadone Clinic in 1987, a program director for the Daytona Methadone Clinic from 1988-1991, with duties including operating a methadone clinic in compliance with state and federal regulations; a regional director from 1991 to 1993 where he had management oversight over all methadone clinic and implemented policies and procedures in a specific geographic area; and vice president of Operations from 1993 until 1997, when Dr. Greene sold his clinics to its current owners. Sheridan was retained as Vice President of Operations by Colonial Management Group, L.P., when it acquired the clinics from Dr. Greene. Intervenor's current organizational structure includes a hierarchy of case managers, program directors, and regional directors. Sheridan is listed on Intervenor's application as the qualified professional, insured training coordinator, and data coordinator and is fully familiar with Chapter 65D-16, Florida Administrative Code, and the duties and functions of each position and stated that he would fill such positions if Intervenor could not hire permanent qualified personnel to fill such positions when the clinic opens. Carol Schwartz will be the program director in Osceola County and is certified as Certified Addictions Professional by the State of Florida. Intervenor identified in its original and updated application that it would open its clinic with three counselors, in addition to its program director. Intervenor identified in its original application and updated application that it would have a licensed professional nurse, Sharon Jones, on staff. She is licensed by the State of Florida. Dr. Greene reviewed the need assessment published by DCF along with a February 19, 1999, letter from the district administrator to Mr. Emenheiser, the "Methadone Authority" and determined that Kissimmee was the best location for the new methadone clinic in Osceola County, as 68 percent of the travel hardship cases lived in Kissimmee. Both Intervenor and Petitioner stated that they anticipated that the clinic in Osceola County would start with about 20-35 patients and would increase over time. Rule 65D-16.014(3)(I)3., Florida Administrative Code, requires that, for methadone programs, there be no more than 45 patients to one full-time counselor. Based on the travel hardship identified by Respondent of approximately 100 patients from the Osceola County area, and a review of Intervenor's organizational chart, Intervenor will be properly staffed to meet the need identified by the Department. Intervenor's application indicated that the program component requested in the application form could grow to 400 patients. Intervenor testified that it adds additional counselors, as needed, to meet the patient-to-counselor ratio required by Respondent. Intervenor's clinic, at all times material to the instant case, has been continuously licensed by Respondent and in good standing. Intervenor has contracted with Dr. Paul "Chip" Roberts to provide medical services in the Osceola clinic on a day-to-day basis. Dr. Roberts' title is that of licensed physician/medical director for purposes of the FDA. Dr. Roberts is a doctor of osteopathy, licensed by the State of Florida, License No. OS-0005120, and has eight years of experience in the field of addiction. Dr. Roberts has worked in the Orlando Methadone Treatment Center, for both Dr. Greene and now Colonial Management Group, L.P., as the clinic's licensed physician/medical director since 1987. Dr. Roberts is responsible for all patients, conducts physical examination, reviews laboratory work, drug screens, and interfaces with nurses and counselors in reference to medical needs. Dr. Roberts can perform the duties in Osceola County, as well as Orlando, as 75 of the patients in Orlando live in Osceola County and will likely transfer. Dr. Roberts, in his capacity as licensed physician/medical director, directly oversees all medical services provided by the program on a day-to-day basis, and his responsibilities are described in Intervenor's policies and procedures manual as required by the rules. Dr. Greene presented testimony regarding the way the policies and procedures operated, the controls in place for inventory, pharmacy, the unique methadone control, staff control, in regard to nurses responsibilities, and how the job is to be performed. Metro's policies and procedures manual consists of 330 pages and over 200 indexed subsections which provide detailed explanations and procedures regarding all aspects of the operation of a methadone clinic, including, but not limited to: administration, program standards, admission procedures, treatment procedures, transfer procedures, detoxification procedures, discharge procedures, pharmacy services and protocols, medical services, and protocols. Intervenor's policies and procedures were developed by Dr. Greene and Sheridan and are updated on an annual basis. Intervenor's written policies and procedures, as submitted at the hearing, demonstrate that its "organizational capability . . . to properly implement the appropriate federal and state methadone regulations" exceeds the organizational capability of Petitioner. Intervenor's original and updated applications contained current general and professional liability insurance policies for Metro, and also covered various physician's whose services are engaged by Colonial Management Group. Intervenor's original and updated applications contained sufficient information that Metro is financially well-able to run the Mid Florida Metro Treatment Center in Osceola County.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Department of Children and Family Services enter a final order selecting Metro Treatment of Florida, L.P., d/b/a Mid Florida Metro Treatment Center, as the service provider to provide methadone outpatient service in accordance with the DCF's determination of need for District 7 and dismissing Petitioner's Petition. DONE AND ENTERED this 15th day of May, 2000, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE 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 15th day of May, 2000. COPIES FURNISHED: Keith A. Graham, Esquire Yovannie Rodriguez-Smith, Esquire Marchena and Graham, P.A. 233 South Semoran Boulevard Orlando, Florida 32807 James Sawyer, Esquire District 7, Legal Counsel Department of Children and Family Services 400 West Robinson Street, Suite S-1106 Orlando, Florida 32801-1782 Wilbur E. Brewton, Esquire Kelly Brewton Plante, Esquire Gray, Harris and Robinson, P.A. 225 South Adams Street, Suite 250 Tallahassee, Florida 32301 Virginia Daire, Agency Clerk Department of Children and Family Services Building 2, Room 204B 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Josie Tomayo, General Counsel Department of Children and Family Services Building 2, Room 204B 1317 Winewood Boulevard Tallahassee, Florida 32399-0700
Findings Of Fact Respondent is a licensed medical doctor having been issued license number 0028827. At all times material hereto, Respondent worked at or operated Health Centers, Inc., a clinic which ostensibly treated persons suffering from stress. At the behest of the Legislature, Petitioner performed a survey of prescriptions for Schedule II controlled substances filled by all pharmacies in the State of Florida. That drug survey revealed that nine different pharmacies in Dade County filled 3,139 prescriptions issued by Respondent between June 1980 and August 1981 for a total of 137,314 tablets of Methaqualone, a Schedule II controlled substance commonly known as quaaludes. Michael Bransfield visited Respondent at Health Centers, Inc. on July 28, 1980, August 26, 1980, December 2, 1980 and December 31, 1980. On the first visit he received a prescription for 45 quaaludes, and he received a prescription for an additional 40 quaaludes on each subsequent visit. On September 17, 1980 Bransfield was admitted to Mount Sinai Hospital after an overdose of quaaludes caused him to fall two stories. The hospital records indicate that Methaqualone was in his blood at the time of the injury. "Drug abuse" was listed on the hospital records as both an admission and discharge diagnosis. In addition to the other injuries Bransfield received in his fall, he fractured his skull and was required to undergo brain surgery for the removal of an epidural hematoma. Bransfield had a set of his medical records from Mount Sinai Hospital forwarded to Respondent. Prior to issuing to Bransfield the 40 quaaludes on December 2, 1980 and the 40 quaaludes on December 31, 1980, Respondent knew that Bransfield had undergone brain surgery as a result of a quaalude overdose. Under the circumstances, issuing prescriptions to Bransfield for quaaludes was life threatening in that it would have been impossible to distinguish a loss of consciousness from drug-induced sleep. Thus, unconsciousness as a result of the head injury would go unnoticed and untreated. Michele Heller visited Respondent on the following dates and received the following prescriptions from him: August 1, 1980 40 quaaludes December 12, 1980 40 quaaludes January 9, 1981 40 quaaludes February 10, 1981 40 quaaludes March 23, 1981 40 quaaludes April 22, 1981 45 quaaludes May 22, 1981 45 quaaludes July 25, 1981 45 quaaludes August 29, 1981 45 quaaludes September 26, 1981 -0- September 29, 1981 45 quaaludes Ana L. Fernandez visited Respondent at Health Centers, Inc. on August 22, 1981 and received a prescription for 45 quaaludes. Methaqualone is a hypnotic drug, used for the production of sleep. It was used initially for the treatment of insomnia but only on a short-term basis- -approximately two weeks--for the reason that it is strongly addictive. By approximately 1980 the use of Methaqualone was largely abandoned by the medical profession since it was well known by that time that Methaqualone was being highly abused, both by drug abusers and by people who wanted to "get high." Since Methaqualone is a depressant, it is an inappropriate medication for a person who is depressed. The medical records of Bransfield, Fernandez and Heller all indicate that they often suffered from depression. The medical records of Bransfield, Fernandez and Heller all indicate that Respondent started them on a monthly prescription of either 40 or 45 quaaludes on their very first visit to him although no tests were administered and no laboratory results obtained in order too ascertain if any of those three patients suffered from some physical problem. The only diagnosis appearing in the medical records of Bransfield, Fernandez or Heller is the word "stress" without any modifiers in explanation of that alleged condition. Additionally, the only "treatment" reflected in Respondent's records of those patients is the monthly prescription of 40 or 45 quaaludes. No other medication was tried, and the only time Respondent failed to prescribe 40 or 45 quaaludes occurred when Heller returned to Respondent's office for her monthly prescription without waiting the required 30 days. Although Heller's medical records indicated on her first visit to Respondent that she awakened rested, Respondent prescribed for her Methaqualone, a sleep producing drug. Respondent's records for Bransfield's December 2, 1980 visit indicate that Bransfield reported be was feeling much improved, that he was dealing with his stress, and that he was feeling that he had control over his present life. Yet, Respondent continued to prescribe 80 additional quaaludes after the patient said that he was better. Respondent's medical records for Bransfield, Fernandez and Heller do not reflect that any of them suffered from any condition for which Methaqualone could be statutori1y prescribed. The mere prescription of Methaqualone is not an appropriate treatment for stress since it does nothing to identify a patient's stressors so that the patient can effectuate necessary life style changes and/or learn how to deal with those stressors.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent guilty of the allegations contained in the Administrative Complaint filed against him and revoking his license to practice medicine under the laws of the State of Florida. DONE and ORDERED this 8th day of March, 1985 at Tallahassee, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904)488-9675 FILED with the Clerk of the Division of Administrative Hearings this 8th day of March, 1985. COPIES FURNISHED: Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Salvatore Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Michael J. Cohen, Esquire 517 Southwest First Avenue Fort Lauderdale, Florida 32301 William A. Cain, Esquire May L. Cain, Esquire 11755 Biscayne Boulevard Suite 401 North Miami, Florida 33181
The Issue The issues are whether Respondent obtained Oxycontin by using a forged prescription, in violation of Section 464.018(1)(h), Florida Statutes, and Rule 64B9-8.005, Florida Administrative Code, which prohibit unprofessional conduct, and in violation of Section 464.018(1)(i), Florida Statutes, which prohibit the unauthorized possession, sale, or distribution of controlled substances; and whether Respondent's use of Oxycontin affects her ability to practice nursing with reasonable skill and safety, in violation of Section 464.018(1)(j), Florida Statutes, which prohibits the inability to practice nursing with reasonable skill and safety by reason of illness or use of alcohol, drugs, narcotics, or chemicals or as a result of any mental or physical condition. If so, an additional issue is what penalty should be imposed.
Findings Of Fact Respondent is a licensed registered nurse, holding license number RN 521142. She has been so licensed for 31 years. Respondent's long career in nursing has featured dedication, hard work, commitment, and competence. The record does not reveal any past discipline. For most of Respondent's professional career, starting in 1971, she has worked at Indian River Memorial Hospital in Vero Beach. Respondent has worked in various capacities at the hospital, including the emergency room and operating room. Respondent later helped develop a neurological unit at the hospital. Starting in 1980, she worked for a couple of years at Vero Orthopedics. Since 1997, Respondent has worked on a contract basis at the Indian River Memorial Hospital, although her present physical infirmities, partly described below, prevent her from working at present. In May 2000, Respondent injured her back while moving a heavy patient in the hospital. A couple of months later, Respondent underwent a laminectomy to relieve the pain from two herniated disks. Six weeks after the surgery, Respondent reinjured her back and had to undergo additional surgery. Six weeks after the second surgery, Respondent, who was not doing well, left her job at the orthopedic clinic and took a less strenuous job. One month after doing so, Respondent was still experiencing pain when she got into and out of cars. In June 2001, Respondent underwent a third operation, in which the surgeon fused two injured vertebrae. The surgery obtained access to the vertebrae by a posterior incision running from the breast to the pubis. The surgery also required a hip bone graft, thus necessitating an incision to the hip. The recovery from this excruciatingly painful surgery was difficult, and Respondent has not yet returned to work, although she is nearing the point at which she can perform some nursing-related work, such as teaching. At present, she still has difficulty walking or standing. When discharging Respondent from the hospital in late June 2001, Dr. Gomez prescribed her Oxycontin for pain. Dr. Gomez was covering for Respondent's neurosurgeon, Dr. Magana. Later, Dr. Cunningham, a pain management specialist and Respondent's family physician, resumed the care of Respondent. Dr. Cunningham continues to monitor Respondent and treat her pain. On direct examination, Respondent testified that she has not taken Oxycontin since December 2001. (However, on August 9, 2002, Respondent told her certified addictions professional that she had not taken any Oxycontin since March 2001.) Respondent testified that, after Oxycontin, she took no pain medication besides nonsteroidal anti-inflammatory medications and steroids. However, on cross-examination, Respondent admitted that she takes Methadose as needed, pursuant to a prescription from Dr. Cunningham. Respondent testified that he switched her from Oxycontin in July 2002. Respondent filled the Methadose prescription at a different drug store than the one that she has used for her other prescriptions. On October 5, 2001, Respondent presented a forged prescription to a different drug store than the one she has used for her other prescriptions. The prescription was for fifty 20- mg. Oxycontin tablets, which Respondent picked up two days later. Respondent fraudulently obtained the Oxycontin for her own use. Oxycontin is an analgesic opioid and a schedule II controlled substance. It is highly addictive and presently among the most commonly abused controlled substances. Oxycontin can produce a feeling of short-lived euphoria, as well as impaired cognitive functioning and impaired judgment. Methadose, a form of methadone, is a synthetic analgesic. It is also used in the detoxification process undergone by heroin addicts. Petitioner has proved by clear and convincing evidence that Respondent engaged in unprofessional conduct in her acquisition of the Oxycontin by using a forged prescription and that Respondent unlawfully possessed a controlled substance. Petitioner has not proved by clear and convincing evidence that Respondent's use of Oxycontin affects her ability to practice nursing with reasonable skill and safety. First, Petitioner did not prove by clear and convincing evidence that Respondent still uses Oxycontin. It appears likely that she may have substituted Methadose for Oxycontin to manage her pain. It is unclear from the present record whether Respondent's use of Methadose is also to assist her in overcoming an addiction to Oxycontin. But even if Petitioner had pleaded Methadose rather than Oxycontin, the record does not reveal the extent to which Respondent presently uses Methadose. For the reasons stated in the preceding paragraph, the relevance of the Methadose is not to prove the third count of the Administrative Complaint, but to underscore the risk that Respondent may pose if she practices nursing at present. Respondent was not candid at the hearing. She was not candid about the October 2001 incident. She was not candid about the recent use of Methadose and was evasive about the drug's properties. The two-hour evaluation that Respondent underwent by a certified addictions professional was cursory and curiously deferential to Respondent. This remarkable evaluation is entitled to absolutely no weight whatsoever. The opinion of the certified addictions professional that Respondent does not suffer from a drug abuse or dependency may or may not be true, but, if true, the result is a chance occurrence, rather than a professional conclusion following the comprehensive collection of relevant, reliable data and the careful, informed analysis of such data. The safeguards provided by the pretrial intervention program, into which Respondent entered after her arrest for the fraudulent acquisition of the Oxycontin, are inadequate. The random drug tests always occur on Tuesdays, just not every Tuesday. The assurances that ensue from Respondent's apparent compliance with the conditions of her probation, which include negative urinalyses, are meaningful, but not sufficiently rigorous to provide the necessary protection to a nurse's patients. On December 26, 2001, Petitioner entered an emergency suspension order in this case. The record amply demonstrates that Respondent will suffer considerable financial distress if denied the opportunity to practice her profession. However, Respondent's lack of candor precludes a detailed analysis of the safeguards in her current monitoring program and a detailed prescription of what, if any, additional safeguards would be required to permit any discipline short of a suspension. In its proposed recommended order, Petitioner seeks a suspension until lifted pursuant to, and subject to the conditions set by, an evaluation coordinated by the Intervention Project for Nurses (IPN); treatment as recommended by the IPN; probation for three years if no treatment is recommended by the IPN; an administrative fine of $750; a reprimand; and the assessment of costs of the investigation and prosecution.
Recommendation It is RECOMMENDED that the Board of Nursing enter a final order finding Respondent guilty of violating Section 464.018(1)(i), Florida Statutes, and imposing a penalty of a $250 administrative fine, a suspension until lifted pursuant to, and subject to the conditions set by, an evaluation coordinated by the IPN; treatment as recommended by the Intervention Project for Nurses; probation for three years if no treatment is recommended by the Intervention Project for Nurses; and the assessment of costs of the investigation and prosecution, upon remand, if necessary. DONE AND ENTERED this 20th day of December, 2002, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 2002. COPIES FURNISHED: Dan Coble, RN PhD CNAA C, BC Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C02 Tallahassee, Florida 32399-3252 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Amy M. Pietrodangelo Assistant General Counsel Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Suzanne H. Suarez Suzanne Hope Suarez, P.A. The Legal Building 447 3rd Avenue North, Suite 404 St. Petersburg, Florida 33701-3255
