Findings Of Fact The Petitioner is the Department of Professional Regulation, Board of Pharmacy. Petitioner seeks to suspend, revoke or take other disciplinary action against the Respondents. Respondent BGJM, Inc. (hereinafter "Save-on Drugs") holds Permit No. 7171 located at 4282 North State Road 7, Lauderdale Lakes, Florida. Save on Drugs has held said permit at all times material hereto. Respondent Robert E. Levy holds Pharmacy License No. 0017283 and has held said license at all times material hereto. Respondent Levy operated Save on Drugs as the sole proprietor and is the only pharmacist employed at the aforementioned store. Respondent Levy, while working at Save on Drugs, between the dates October 16, 1981 and April 2, 1982, dispensed approximately 139,000 Methaqualone tablets on 3,136 prescriptions. Respondent Levy ceased dispensing Methaqualone tablets approximately three (3) weeks prior to the institution of Petitioner's investigation of Respondent Levy's dispensing of controlled substances. The Respondent dispensed, over a three-month period, some 57,250 units of Methaqualone on behalf of one practitioner, a Dr. Lena. A specific breakdown of Dr. Lena's prescribing activity for part of the relevant period is as follows: DATE PHARMACY DRUG AMOUNT SCRIPT 12/14/81 Save-On Quaa-300 mg. 630 14 12/15 Save-On 720 16 12/16 Save-On 495 11 12/17 Save-On 765 17 12/18 Save-On 1,440 32 12/21 Save-On 945 21 12/22 Save-On 1 x 30 mg. 675 15 12/23 Save-On incl. 1,080 24 12/24 Save-On 1,215 27 12/28 Save-On 1,035 23 12/29 Save-On 1,305 29 12/30 Save-On 1,575 35 12/31 Save-On 1,305 29 Totals 13,185 293 The numerous prescriptions introduced into evidence by the Petitioner reflect circumstances where Respondent Levy failed to properly initial and date Schedule II prescriptions as they were filed. As example, Petitioner offered the following: prescription Nos. 48854, 48052, 50189, 48068, 48856, 48912 and 48905. Louis Fisher 2/ , an employee of the Department of Justice, Drug Enforcement Administration, since approximately November, 1971, has been involved with the regulation of controlled substances. Mr. Fisher works with doctors as well as pharmacists at the retail level. Mr. Fisher is a registered pharmacist and has been charged with drafting regulations for controlled substances. Without question, Methaqualone is a Schedule II drug and is a sedative and hypnotic agent. The drug has a high abuse potential. During the summer of 1982, Methaqualone was changed from Schedule II to a Schedule I controlled substance. After being provided with a hypothetical situation giving the number of prescriptions that Respondent Levy had filled during the time period involved, Mr. Fisher concluded that a pharmacist filling the number of prescriptions within the time period as is here involved by Respondent Levy was, in Mr. Fisher's opinion, unprofessional, excessive, outside the course of good professional practices, and not conduct amounting to professional practice in the patients' best interest. 3/ Dr. Lena was employed by Northeast Medical Services, a stress clinic. In this regard, the parties stipulated that all the prescriptions involved herein were written by a licensed medical doctor. Daniel O'Connell, an investigator with the Department of Professional Regulation, visited the Respondent's store during approximately October 1981, and performed a routine change of ownership inspection. At that time, Respondent Levy engaged in a conversation with investigator O'Connell at which time Respondent Levy was apprised of the problem with respect to dispensing Methaqualone in the south Florida area. Jim R. Golden, an investigator with the Department of Professional Regulation since approximately September 1981, visited Respondent Levy's store during April 1982, to perform a routine inspection to determine the amount of Schedule II drug prescriptions that Respondent was filling. Investigator Golden reviewed a large number of prescriptions that were filled by Respondent for Dr. Lena and inquired of Respondent the reason for dispensing such a large number of prescriptions for Methaqualone tablets. Respondent Levy replied that it was the "money end of it" and that he (Respondent) could fill six (6) Methaqualone prescriptions and do better with those prescriptions from a profit viewpoint than he could with the remainder of his other prescribing activities in the store for the remainder of any given day. Further, Respondent related that he hand to do extensive repairs to make the store operational. (Testimony of Investigator Golden)
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED: That Respondent BGJM, Inc.'s Permit No.7171 be REVOKED. That Respondent Robert E. Levy's Pharmacy License No. 0017283 be placed on probation for a period of two (2) years. RECOMMENDED this 12th day of May, 1983, in Tallahassee, Florida. JAMES E. BRADWELL, 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 12th day of May, 1983.
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 At all times pertinent to the allegations involved in this hearing, Respondent, Robert A. Lieberman, was licensed to practice medicine in the State of Florida. John P. Spanogle, an investigator with the Department of Professional Regulation since 1980 and with the Board of Medical Examiners prior to that back to 1975, in November, 1979, was requested by representatives of the Orlando Florida Police Department to work with their detectives in several ongoing drug investigations. Respondent was not the subject of any of those particular Orlando Police Department investigations. However, during the course of these investigations, Mr. Spanogle secured certain prescriptions for Class II controlled substances that were written by the Respondent. As a result of these prescriptions, Mr. Spanogle interviewed the Respondent on July 7, 1982, at Respondent's office. At the outset of the interview, Mr. Spanogle advised Respondent of the nature of the allegations and of his rights regarding being questioned. He found Respondent to be extremely cooperative and received full answers to the questions asked, as well as patient release forms and patient records as to the patients listed in the various counts of the Administrative Complaint. During the course of the interview, Mr. Spanogle and Dr. Lieberman discussed several of the doctor's patients and the prescriptions he had written for them over the period in question. Dr. Lieberman seemed surprised he had prescribed so many Percodan and other drugs and could not readily explain why he had written so many prescriptions. Only one of the doctor's former patients testified for the Petitioner at the hearing. This was Linda Gorsuch Creed, a/k/a Linda Clary Morgan, the individual described in Count I of the Administrative Complaint. Ms. Creed is a former drug abuser who started abusing drugs when she was 18 years of age. She is now 26. During the course of her drug abuse, she used such substances as heroin, Dilaudid, Demerol, and others, injecting them into her arms and hands. She first saw Respondent in early 1979 for the purpose of securing drugs. Dr. Lieberman did not know this, however, because her stated complaint was of not being able to have sex without pain. This, however, was false. During the first visit, she was examined by the Respondent and was nude except for the examination gown. She cannot state whether she had drug injection track marks on her arms, but imagines she did since she was using drugs at the time. She does not know whether Respondent saw them, if in fact she had them. Respondent denies noticing any track marks on the witness; and on the basis of the evidence as presented, it can be concluded, reasonably, that Dr. Lieberman was not aware that this patient was in fact a drug abuser. During the first visit, she asked for Dilaudid and Valium and was given a prescription for both. Several months later, she again visited Dr. Lieberman for the purpose of securing drugs. On this visit, she complained of cramps, which again was not true, but at the conclusion of the visit was issued a prescription for Dilaudid. Approximately four years later, she again visited Respondent for the purpose of procuring drugs. At this time, she was mainlining and presumes that she had tracks which she feels may have been seen by the doctor. However, she asked for and received drugs based upon her represented "illness" and the Respondent's examination of her. Just about this time, she was arrested for drug abuse. At the time of her arrest, she had a prescription bottle for Dilaudid and one with Valium in it, both of which she had received from the Respondent. While she was out on bond, she again went to see the Respondent and asked for drugs. He refused, however, to give her any at this time because he had finally become aware that she was abusing drugs. She saw him several times thereafter and, on each occasion, he gave her only legitimate prescriptions; and she has not taken any illegal drug since 1980. The testimony of Dr. Lieberman on this same patient is consistent with that of the patient herself, though from a different perspective. The doctor's records reflect that the first visit from this patient on January 10, 1979, concerned her claim that she had had no period for three months and was in great pain. Examination revealed that her stomach was distended. He did a pelvic examination and found that her vagina was inflamed and she had a vaginal discharge. He gave her antibiotics for the infection and suggested that she have a laparoscopy examination in which a light device is passed through the navel into the fallopian tubes. The conditions described by the patient, if true, are in fact painful. The lack of period can be extremely painful because as a result the organs are swollen with fluid. The vaginal discharge and the history associated therewith indicated a possibility of pelvic disease and an inflammation of the fallopian tubes. It was for this reason that the laparoscopy was suggested. Because it was obvious that the patient was suffering great discomfort and because of her representation that Dilaudid was all that helped her (she was allergic to codeine and aspirin), he prescribed that drug for her. It is significant to note here that her allergy to codeine and aspirin limited the painkillers she could take and, as a result, which he could prescribe. He states that at the time of the examination, he saw no drug tracks on her body and did not know that she was an addict. He cautioned her on Dilaudid's addictive propensity and wanted her to have the laparoscopy so as to get her off Dilaudid as soon as possible. Dr. Lieberman was again visited by Ms. Creed in March 1979, approximately two months after the first visit. During this second visit, in which she stated she again had no period in the intervening two months since the first visit, the examination reflected that her stomach was tender, as were her organs, as well. The doctor gave her a hormone to start and regulate her periods and Dilaudid for the pain. On each prescription, Dr. Lieberman prescribed 20 capsules of Dilaudid. This drug is for severe pain, and he prescribed it only because, in his professional judgment, he felt she was in pain severe enough to justify it. Wilda Sue Boudreaux, another of Respondent's former patients, went to see him in May 1979, for the treatment of female problems. Dr. Lieberman recommended she have a hysterectomy, to which she agreed. She went into the hospital on May 23, 1979, for that operation and a bladder tac with removal of preexisting adhesions. Both operations were successful, and she was released after seven days' hospitalization. Dr. Lieberman saw her several times during her postoperative course of treatment. The surgery was done during the second or third day she was in the hospital. After the surgery, she was having severe pain and complications with a nerve in her leg that had been nicked during the hysterectomy surgery. After she was released from the hospital, because of these conditions, she was in constant, severe pain to the point she could not walk. Pain radiated through her leg and her lower body. She communicated these complaints to the doctor and received from him a prescription for Percodan. The Administrative Complaint alleges she received prescriptions on June 4, 5 and 19 and September 4 and 12. Ms. Boudreaux admits having received all prescriptions except the one on June 5 and denies emphatically that she received prescriptions for Percodan two days in a row. At the time the doctor prescribed Percodan for her, he told her it was a strong drug and should be taken carefully. She requested it, however, because it was the only drug that helped her. A couple of months after this surgery, she developed a urinary infection which resulted in severe pain during urination. She also continued to have severe pain in her left side where the leg nerve damage was and repeated pain from the prior surgery. She went back to the Respondent for a follow-up visit, and he hospitalized her for further tests. As a result of the tests, it was determined that the pain was due to severe nerve damage and that the pain would continue for some extended time until the nerve damage healed. Ms. Boudreaux considers Dr. Lieberman to be a good doctor who was concerned about her as a patient and who, at the time he gave her a prescription, explained to her why she was having the problems, what drugs he was giving her and what the drugs were for. It is her opinion that, throughout the entire period of time she was in contact with him, he appeared to be concerned about her as a person, not only as a patient. Respondent's testimony regarding his treatment of this patient was consistent with hers. He first saw her in March 1979, when she had a complaint regarding constant vaginal bleeding, painful periods and, as a result, he determined that she needed a complete hysterectomy, including complete removal of the tubes and ovaries, and surgery for preexisting bladder problems. During that operation, she sustained damage to a nerve which resulted in constant pain in her leg and abdomen. Nerve damage is one of the slowest types of damage to heal. As a result, this patient experienced constant pain over a long period after the surgery. On top of that, she developed a urinary tract infection as a result of the bladder surgery. As a result, she was maintained on Percodan until the infection cleared up and the nerve damage repaired itself. In the doctor's opinion, all the prescriptions for Percodan were appropriate. It is important to note here and with regard to the other allegations not the date of the prescriptions, but when and how they were to be used. Ms. Boudreaux is a school bus driver and a very responsible person; and Dr. Lieberman felt it was appropriate to prescribe Percodan as he did for her to stockpile them so that she would not have to come back into his office so often. In fact, she did not come back after June 19 until September 4, almost three months later. At that point, she still had the nerve damage and the bladder infection was first discovered. Petitioner made much of the fact that there may have been a less addictive drug that could have been used, both for this patient and for Linda Creed. Respondent claimed, however, that, based on his knowledge of the case of the individuals, he had no reason to disbelieve them; and in the case of Linda Creed, when she said Dilaudid had worked previously, he prescribed that in good faith. There is no evidence to show he did other than that in any case. Regarding the allegations pertaining to patient Patricia Rousseau, the patient information reflects that when first seen by Dr. Lieberman, Ms. Rousseau was a 30-year-old waitress with one child. She appeared well kept and was the sole support of herself and her child and needed to continue to work. At the first visit on July 9, 1979, Ms. Rousseau came in for an abortion, which was accomplished. At the time of her release, Dr. Lieberman prescribed 20 Percodan tablets to be taken one every six hours because, in this case, he thought it was medically indicated. Ms. Rousseau indicated she was in severe pain; and, based on the doctor's experience, he was convinced that, as a result of the procedure followed surgically, the pain could last for at least five days, which was the time it would take to use 20 tablets, taking one every six hours. Dr. Lieberman saw Ms. Rousseau again in January 1980. By this time, she had gotten pregnant again and wanted another abortion. She advised him that she had been to a clinic for that procedure and had developed an ovarian cyst. When Dr. Lieberman examined her, he felt that she could have a cyst, which, in his opinion, is a painful condition, and gave her medication for it. Here, he feels Percodan was indicated because of the fact that the condition arose from a second abortion and the additional pain that went along with it. Along with this condition, she also had dismenhorreah, a condition manifesting itself in painful periods, which, according to the Respondent, can be extremely painful and, in some women, totally disabling. Considering the fact that the patient needed to continue to work, as she was the sole support of herself and her child and could not be bedridden because of her period for three to five days each month, he felt Percodan was indicated, which he prescribed 15 or 20 at a time once a month for use during her period. The quantities prescribed were not, in his opinion, excessive. An additional patient who visited Respondent and whose course of treatment was considered to be improper by Petitioner was Martha Star Curtis, whose first visit to Respondent was on July 27, 1978. She was complaining of lower abdominal pain which, upon examination, turned out to result from a pregnancy. On August 2, 1978, this pregnancy was aborted. Her medical history, taken by Dr. Lieberman, revealed a prior ectopic pregnancy in the right tube and a lost tube and ovary. The following year, she had a cyst removed from her left ovary. At her first postoperative checkup, three weeks after surgery, Dr. Lieberman noticed a small ovarian cyst. When she came back a month later, the cyst was larger and was very painful. This pain related to the cyst was magnified because of chronic pelvic inflammatory disease, and Dr. Lieberman proposed to do a laparoscopy. Ms. Curtis had previously agreed that if this procedure had shown anything irregular, the doctor could go in, check it out and take care of whatever problem existed on the condition that her reproductive capability not be removed. As it turned out, upon accomplishment of the procedure, the doctor discovered that Ms. Curtis had substantial internal scar tissue in her pelvic area which had attached itself to her bladder, tubes, ovaries, intestines, interior of the "belly" and other internal and pelvic areas. This creates almost debilitating, constant pain as scar tissue develops, which increases as the scarring advances. Movement makes it worse--even the simple movements of walking, turning, etc. Even when the scar tissue is removed, it comes back unless there is a hysterectomy. Contra to this theory is the testimony of the Petitioner's expert, Dr. Lewis, who opined that movement not of the individual, but of the organ, would create pain. This difference in opinion is not particularly significant, however, as it is hard to conceive how movement by an individual, unless undertaken with an extremely delicate step, would not result in movement of the organs. In any case, since Dr. Lewis did not examine the patient, was not familiar with her nature, her makeup, or her disposition, it is more logical to assume that the physician who treated her over an extended period of time would be more acquainted with her condition and with the results of her activities than would one who sits in his office examining merely records. In this case, therefore, the observations and opinions of Respondent, who treated the patient, who performed the surgery and who was familiar with the individual, prevail. It is also pertinent to note here that Ms. Curtis, at the time this situation was going on, had met a man she intended to marry and bear children for. As a result, she did not agree to have the needed hysterectomy that was the only procedure that would cure the problem and remove the pain, at least until such time as she conceived and bore this man a child. Therefore, under those circumstances, in the opinion of the Respondent, Percodan was appropriate. Even though they are frequent and repeated, in his opinion, in light of her circumstances, her mental, physical, emotional and situational needs, this regimen was called for. While the Physician's Desk Reference indicates the standard dosage of Percodan as one every six hours, it also provides that this dosage can legitimately and should be exceeded when the situation calls for it. It is pertinent, also, to note here that Ms. Curtis at this time was traveling with her intended husband, a truck driver, in his truck, a situation which created more pain than would normally be experienced, and because of that could not come into the doctor's office as often as necessary. Therefore, in light of the fact that she would not agree to the only procedure that would alleviate her pain, the hysterectomy, and insisted on traveling with her putative husband, it was imperative that she receive relief from the pain, and Percodan was the only thing that would do it. Dr. Lieberman also treated a Julie Londy, first on August 18, 1980, when she came to see him, complaining of chronic pelvic pain, chronic bleeding from the vagina and painful periods. This lady was married, wanted no children and desired a hysterectomy. She entered the hospital for that procedure on April 22, 1980, and had a total abdominal hysterectomy plus an appendectomy on April 24, 1980. She was discharged on May 3, 1980. The conjunction of two major surgical procedures may have increased her pain, and her pain may have carried over from the previous condition she was experiencing, thereby reducing her tolerance for pain. Dr. Lieberman prescribed Tylox on three separate days within a six-day period, May 3, 7 and 9, 1980. Tylox is a Class II drug which is indicated for the reduction of pain. The generally accepted dosage is one every six hours, except in extreme discomfort, when the dosage can be increased. In this case, Ms. Londy was experiencing great pain because, coincident with her recuperation from the hysterectomy and appendectomy, she was experiencing a bladder infection; and, since she is allergic to codeine, Demerol, Dilaudid and aspirin and had told Respondent that Tylox was the only medication that would relieve her pain to which she was not allergic, he prescribed that substance. The first prescription was given on May 3, 1980, the day of her discharge from the hospital, and consisted of 40 pills. That should have lasted for ten days at the normal rate. The second prescription, for 30 pills, was given four days later because she was experiencing great discomfort. The third prescription, for 40 more, was administered on May 9, 1980, at her regular follow-up visit, after which the doctor was not to see her again for at least a month. It was his intention, by prescribing so many pills at one time, to give her a restful postoperative recovery; and the large number of pills was an advance. As a matter of fact, after May 9, the doctor did not see her again until late June 1980, some six weeks after the date of the last prescription. At that time, she was experiencing no pain, and neither asked for nor received additional narcotics. Respondent first saw Marilyn Quantrill on February 1, 1977. At that time, the patient, a 21-year-old female, was in early stages of pregnancy and wanted an abortion. This procedure was accomplished on February 7, 1977. Shortly thereafter, she got pregnant again and, despite the fact that she was being beaten by her husband, she decided to have the baby and did. Her husband continued to beat and emotionally abuse her (threats to take the child) to the point that she was a "nervous wreck." When she came to see Dr. Lieberman for the Seconal on July 17, 1978, her condition was such that she could not sleep because of her relationship with her husband, and Respondent gave her the Seconal to help her sleep. She was experiencing difficulty in coping with stress, and this condition is made worse by lack of sleep. She needed to sleep, and he gave her the pills in question to help her sleep. He thought his prescription for one pill per day at night for sleep was appropriate. The total number of Quaaludes prescribed over the five-month period was 210 pills. The period in question accounted for approximately 163 days. This is slightly over one pill per day, not notably excessive. It is also noted that Dr. Lieberman initially prescribed Seconal, thereafter switching to Quaaludes. He discontinued the Seconal because it was not strong enough to provide the necessary effect in light of her situation. It is also noted that Ms. Quantrill's husband was reported to be a drug dealer. When Dr. Lieberman found out this was the case, he not only stopped providing drugs for Ms. Quantrill, he declined to take her as a patient any longer. In the case of patient Stormy Druga (Smith) who received a drug called Eskatrol on three different occasions for weight loss, the allegation is not that the doctor prescribed improper amounts of the drug, but that the drug was prescribed for a purpose not permitted under Florida Statutes. Dr. Lieberman admits prescribing the drug on the date set out and the amount. He had used this drug for this patient before because she was overweight. She had just had a hysterectomy, was getting a divorce and desperately wanted to lose weight to improve her appearance. The prior use was successful in that she lost 30 pounds. Though Dr. Lieberman subscribed to numerous publications, he did not know that Florida had changed the law, prohibiting the use of Eskatrol for diet purposes. During the period in question, from August through November 1980, Ms. Druga came in every month for a weight control regimen, and he prescribed 30 pills each visit for a total of three visits. Unknown to him, the Florida Legislature had recently changed the law, prohibiting the use of any amphetamines or sympathomimetic amine drug or a compound designated as a Schedule II controlled substance, except for certain conditions of which weight control is not one. The first notice that Dr. Lieberman had that the law was changed was a bulletin issued by the Department of Professional Regulation in February 1981, three months after he stopped the prescription. In that regard, Dr. Lewis, the Petitioner's witness, stated that according to his experience, a doctor becomes aware of a change in one of several ways: (1) drug company flier, (2) a pharmacist's comment, and (3) national subscription-type letters. However, the State does not normally send out any bulletins regarding changes at the time the change is considered or initially made. Under these circumstances, it is quite likely that Respondent was not aware of the fact that the law had changed, prohibiting the use of Eskatrol for weight control purposes, during the time he prescribed it for Ms. Druga, as alleged. Each allegation against Respondent was evaluated by an expert in the field of obstetrics/gynecology for both Petitioner and Respondent. Petitioner's expert, Dr. Lewis, concluded, with regard to Ms. Rousseau, at least, that Respondent's charting is weak; he did not indicate on the record if the patient was seen on any of the visits which resulted in the issuance of a prescription and that Percodan, in this case, was prescribed without any clinical entry of observations on the records. On the other hand, Respondent's expert, Dr. Harry J. Stone, concluded that Percodan was appropriate in both the substance and the amount prescribed for Ms. Rousseau, a total of approximately 320 capsules over a two-plus-year period. If, as was claimed by Dr. Lewis, none of the prescriptions are charted, even that does not constitute malpractice because, according to Dr. Stone, in the practice of obstetrics end gynecology, quite often medications are not charted when the doctor is called out on an emergency situation before he can put it on the chart. As to Ms. Druga, Dr. Lewis indicated that Eskatrol was withdrawn from market use for weight control in 1980 because so much got into the Black Market and because of the undesirable side effects of amphetamines. The records examined by the doctor, which cover a period of time not alleged in the Administrative Complaint, show that over a period consisting of one year, five months and 21 days, Ms. Druga received 480 capsules and diuretics with a total weight loss of 10 pounds. While this is not successful weight loss maintenance, it is nonetheless not unusual depending upon the individual. Dr. Stone, himself, did not know of the change in the law regarding Eskatrol when it went into effect on July 1, 1980, and in his opinion, knowledge of this change within the medical community was poor. Both experts are in agreement that the State does not notify doctors of the changes, as the federal government does. The notices generally go to the pharmacists and, as a courtesy, the pharmacist should have called the Respondent, especially since the prescription here clearly stated it was for diet control. There is no question that prescriptions were issued for Eskatrol by Dr. Lieberman at a time when the law had been changed to prohibit the use of that drug for weight control purposes. It is equally clear, however, that Dr. Lieberman was unaware of the change and that insufficient effort was made by the State at the time to provide knowledge of the change to the various physicians. Turning to Ms. Quantrill, Dr. Lewis feels that because the patient came in and requested Valium and thereafter, as indicated in her letter to the Respondent, took 30 milligrams at one time, which is an excessive dose, Respondent should have suspected that she was likely to abuse drugs. She received prescriptions for 210 Quaalude capsules within a 163-day period. Dr. Stone, on the other hand, opined that the amounts in question were justified based on the emotional strain the patient was undergoing, as well as the pain from her condition. As to Ms. Creed, Dr. Lewis feels that when a patient asks for a particular Class II drug, that is characteristic of an addict, and he does not believe that Dilaudid was called for when Respondent administered it. On the other hand, Dr. Stone, based on the medical records he reviewed, including patient's case history, feels that under the circumstances of the first visit, the prescription of Dilaudid was appropriate in both substance and amount because of the acute pain associated with chronic pelvic disease. The antibiotics that were prescribed by Dr. Lieberman to cure this condition take a long time to work, and the patient needs help to stand the pain. If Dilaudid had worked in the past, it was not inappropriate to use it again. As to the second visit when Ms. Creed got Dilaudid, Dr. Stone feels that again the drug and the amounts prescribed were appropriate for much the same reasons. As to Ms. Boudreaux, Dr. Lewis feels that Respondent's records do not show any complications, and he feels that the drugs prescribed were too much in quantity for an uncomplicated postoperative course. It should be noted here, as elsewhere, that Dr. Lewis, in examining Dr. Lieberman's records, is at times very critical of them as being not complete enough, but at other times relies on them to support his viewpoint. For example, the witness uses the number of pills listed in the record to support the conclusion of over prescription without knowing the patient or having seen her, but when asked if the records say that Respondent stopped prescribing the drugs, this same witness states, "But we don't know what transpired because it's not in the record of what he saw the patient about, whether a medical problem or a drug problem." Dr. Stone, on the other hand, is of the opinion that the prescription of Percodan for Ms. Boudreaux was appropriate because of the combination of the two operations., the insertion of a painful catheter for a long period (six days) , the infection (which was painful) and the nerve injury (very painful). Because of the second hospitalization for the infection in September, Dr. Stone feels that the Percodan prescribed in September and October was appropriate. There does not appear to be an opinion from Dr. Lewis on the treatment given to Ms. Curtis. Dr. Stone, however, opines that the Percodan prescribed by Respondent for this patient from March to July 1979, was justified because of the repeated surgery. A second operation in the same area as former surgery is very painful. This drug can be given and was given at a prescribed rate of one every four hours as necessary for pain. In the opinion of Dr. Stone, this is reasonable, even though the Physician's Desk Reference calls for administration of one every six hours. In addition, continued use, which admittedly this patient had done, develops a tolerance which can result in raised usage. Therefore, even though Dr. Lieberman prescribed 830 pills over 121 days, a rate of almost seven a day, while higher than normal, this is not so aberrant a prescription rate under these circumstances as to be considered necessarily inappropriate or constitute substandard practice. Dr. Lewis also did not give an opinion as to Ms. Londy, for whom Tylox was prescribed. Dr. Stone, on the other hand, felt that the use of Tylox in the amounts prescribed was justified. Here, the patient had undergone major surgery, including an appendectomy, had had implanted a drain and had developed a fever, which indicates infection, with swelling and pain. All of these conditions justify the use of the drug in the amounts. Though the total quantity may seem high, it should be noted, however, this was only for a short period, and the pain of all the surgery and the patient's condition under these circumstances rendered this prescription in this amount not necessarily inappropriate. Based on his overall evaluation of the various patient records and his knowledge of Dr. Lieberman gained from observing him on staff at Florida Hospital and Respondent's excellent reputation as a gynecological and obstetrical surgeon in his community, he is satisfied there has been no gross or repeated malpractice in what Dr. Lieberman has done. Further, his review of the records reveals no indication of fraud, trickery, or any of the other alleged deceptive representations or any indication of bad faith on the part of the Respondent. Petitioner offered no evidence of these latter characteristics. Turning to the issue of medical stockpiling, however, Dr. Stone is quick to admit and recognize that the stockpiling of medicines as was done here in some cases by this Respondent is not a good idea. However, in the world as it exists, it may in some cases, and he is of the opinion that it was in the cases here, be acceptable practice, and not malpractice. Respondent, who has treated approximately 10,000 patients since he entered medical practice in 1976, routinely prescribes controlled substances in his practice. When he does so, he uses a high degree of care because of the addictive nature of Class II drugs. Before prescribing, he considers the individual and their medical problem needs. Modern OB/GYN practice allows physicians in these specialties to serve as "full" physicians to women, and they can treat their patients for illnesses other than those related to the OB/GYN practice. Under this situation, the doctor is required to also consider the emotional, physical, psychological and socioeconomic needs of his patients. It is wrong to merely consider records. A doctor treats people.
Recommendation On the basis of the above, it is, therefore, RECOMMENDED: That the Administrative Complaint against Respondent, Robert A. Lieberman, M.D., be dismissed and no disciplinary action be taken against him on the basis of the activity alleged in this Administrative Complaint. RECOMMENDED this 31st day of January 1984, in Tallahassee, Florida. ARNOLD H . POLLOCK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 31st day of January 1984. COPIES FURNISHED: Barbara K. Hobbs, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Herbert M. Hill, Esquire Thomas Michael Burke, Esquire Post Office Box 1873 Orlando, Florida 32802 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Ms. Dorothy Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact At all times material hereto, Respondent has been a physician licensed to practice in the state of Florida, having been issued license number ME 0044173. She practiced medicine in Key West, Florida, from 1985 through June 1993 when she closed her office as a result of a family problem and moved to West Virginia. She is licensed as a physician in West Virginia and currently practices medicine in that state. Respondent is Board-certified in internal medicine. In April 1993, Petitioner's pharmacy inspector responded to telephone calls from pharmacists in Key West concerning Respondent's prescribing practices by traveling to Key West and reviewing pharmacy records of Respondent's patients. One of Petitioner's investigators thereafter collected and compiled copies of computer printouts from six pharmacies listing prescriptions filled for seven of Respondent's patients. Respondent had worked at a clinic where she experienced approximately 15,000 patient visits per year. After determining that Respondent had prescribed what he considered to be an inordinate amount of controlled substances, Schedule II narcotics, the investigator wrote to Respondent advising her that an investigation had been commenced. In July, Respondent telephoned him and advised him that she had relocated to West Virginia. The investigator asked her for the medical records for the seven patients he questioned, and Respondent advised him that in conjunction with her closing her practice and relocating, she had given their medical records to approximately 500 of her patients so they could take them to other physicians and continue receiving their medical care, and those records not picked up by patients had been sent to a Dr. Garriques to be the custodian of those records. Of the seven medical records requested by the investigator, six of them had been given to the patients, and the seventh had been transferred to Dr. Garriques. Respondent admitted that she had not personally kept either the originals or copies of the medical records of her patients. The investigator subsequently telephoned Sun Belt Clinic where Respondent had worked and was told that Respondent's medical records were not there because she had given them to her patients. In December 1993, the investigator issued a subpoena to Sun Belt Clinic for Respondent's medical records and received nothing. Petitioner has made no further effort to obtain the medical records of the patients involved in this proceeding. Controlled substances are categorized by the Drug Enforcement Agency in five different schedules according to their potential for abuse. Schedule I substances are illegal. Schedule II substances, although considered highly addictive, can be prescribed by licensed physicians for medical purposes. Schedule II substances can be narcotic (opiates administered for pain) or non- narcotic. Schedule II narcotics include morphine (morphine sulfate), methadone (dolophine), dilaudid (hydromor-phone), and oxycodone (percodan and percoset). Dexedrine is also a Schedule II controlled substance. Although morphine is the most potent narcotic available in the United States, only approximately 10-20 percent of it is absorbed, when ingested. Methadone is available in government-run clinics for the treatment of heroin addiction. Methadone is also a bona fide treatment for pain. Pursuant to the statutes regulating the conduct of registered pharmacists in the state of Florida, pharmacists are not permitted to dispense methadone for addiction; rather, pharmacists can only dispense methadone as a pain medication. At least one doctor in Key West, other than Respondent, prescribes methadone for pain, and a local hospital there has begun using methadone to treat pain on an in- patient basis. L.P., one of Respondent's patients, is a narcoleptic. Narcoleptics need a stimulant, such as dexedrine or ritalin, to function normally. Before seeing Respondent, L.P. had been "worked up" at Stanford and was taking a maintenance dosage of dexedrine. Between September 11, 1992, and June 1, 1993, Respondent prescribed dexedrine, 15 mg., for L.P., the same dosage L.P. was on before and after being Respondent's patient. The amount and frequency of dexedrine prescribed by Respondent for L.P. is within the range recommended by the Physician's Desk Reference and was an appropriate treatment for L.P.'s narcolepsy. Persons suffering from chronic pain (as opposed to acute episodes of pain) for which there is no cure or treatment available that can alleviate the person's pain are said to suffer from "intractable pain." There are two types of patients who suffer from intractable pain. The first group are patients with terminal, irreversible illnesses, such as cancer patients. Physicians generally give those patients whatever narcotics they need to alleviate the pain during the end stage of their lives. The second group is composed of patients who suffer from non-terminal disease processes who have tried different specialists and treatments available without achieving relief from their chronic pain. Those persons are generally not treated in family practice settings but rather are referred to pain management centers or pain clinics, in locations where such are available, to have their pain alleviated by treatments such as receiving morphine implants or having doctors perform nerve blocks. Many physicians avoid caring for patients who require Schedule II controlled substances to alleviate their suffering. The United States Department of Health, Education and Welfare, through its Agency for Health Care Planning and Research, has established national guidelines for treatment of moderate to severe pain in cancer patients, using Schedule II narcotics. The guidelines are written as a starting dose for opiate-naive adults, i.e., adults who have never before taken opiates. The guidelines further indicate that adults who are not opiate-naive may need a stronger dose. Although none of Respondent's other five patients involved in this proceeding were cancer patients, they suffered from intractable pain. Respondent prescribed narcotics for them within the guidelines recommended to relieve intractable pain in cancer patients. The Agency for Health Care Planning and Research recommends for moderate to severe pain a starting dose of dilaudid of 6 milligrams every three to four hours with a maximum recommended dose of 24 milligrams a day. It recommends a starting dose for moderate to severe pain for methadone or dolophine of 20 milligrams every six to eight hours with a maximum of 80 milligrams a day. For morphine, Agency guidelines recommend a starting dose of 30 milligrams every three to four hours. As to those five patients discussed hereinafter, Respondent saw each of them two times a week when they came to her for their prescriptions. In that way, she was able to monitor them closely and write prescriptions for limited quantities of medication. Sometimes, she saw those patients more often since the pharmacies in Key West were not able to stock supplies of narcotics as easily as non-narcotic medications. If a patient brought a prescription for such narcotics to a pharmacy and the pharmacy had an insufficient quantity in stock to fill that prescription, the patient could go elsewhere or could take the quantity the pharmacy had in stock. Under that circumstance, the prescription for the full quantity would be cancelled, and the patient would return to Respondent to get an additional prescription in order to have the full dose prescribed by Respondent. Respondent treated J.P. for six years for migraine headaches on an indigent basis. J.P. could not afford a CAT scan, and there were no other resources in Key West available to him for further work-up at no cost. Respondent based her treatment plan on her best clinical judgment and a complete physical examination. She tried Midren and other anti-inflammatory medications first. She prescribed percoset for three or four years. She then tried dilaudid. She prescribed dilaudid, 2 mg. from March 19, 1992, through April 23, 1992. She then prescribed dilaudid, 4 mg., from April 30, 1992, through August 17, 1992. From September 3, 1992, through November 30, 1992, she prescribed dolophine, 10 mg. On December 4, 1992, she changed J.P.'s treatment, prescribing morphine, 30 mg., through January 29, 1993. Pharmacy records reflect other medications thereafter, with a prescription for 15 dilaudid, 4 mg., on March 24, 1993, followed by 8 morphine sulfate tablets, 30 mg., on May 21, 1993; 5 percoset tablets on May 31, 1993; 15 morphine sulfate tablets, 30 mg., on June 4, 1993; and 5 percodan tablets on June 7, 1993. Although J.P. filled Respondent's prescriptions at several pharmacies, for example using three different pharmacies during the month of January 1993, the total amount of medication prescribed by Respondent was within the federal Agency guidelines. Respondent's prescribing practices as to J.P. were appropriate and not excessive. Over the course of her treatment of J.P., Respondent observed him change from a "non-functional" person to a functional person who was able to hold a job as a chef when his pain was relieved. Respondent treated M.G. for AIDS-related cluster headaches, which are very intense. He was also grieving for his girlfriend who had died of AIDS. Respondent treated him with dilaudid, which made him pain-free most of the time, and, in addition, he learned relaxation techniques to help deal with his pain. Respondent maintained him on a dosage of dilaudid, 4 mg., from December 28, 1992, through early March 1993. The quantity of dilaudid prescribed by Respondent was within the federal Agency guidelines, and was appropriate and not excessive. While taking dilaudid, M.G. was able to work four days a week as a taxi dispatcher. Respondent treated C.D. for chronic severe pain resulting from connective tissue disease. C.D. also suffered from intermittent gland swelling. Respondent unsuccessfully tried numerous anti-inflammatory medications in treating C.D., and he was treated by a rheumatologist in Miami without benefit. Respondent placed him on a maintenance treatment plan of 100 mg. a day of morphine and kept him at that level. Pharmacy computer printouts reveal C.D.'s morphine treatment commencing in February of 1992 and continuing into mid-June 1993. His functioning improved so that he was able to obtain a job as a taxi driver and once again start playing his guitar in a band. The maintenance program Respondent instituted for C.D. was within the federal Agency guidelines and was appropriate. Respondent treated J.B. for six years for multiple orthopedic problems and back pain. J.B. was not opiate-naive. He had been severely abused as a child and started taking narcotics at the age of two when he suffered a broken arm and severe burns to his hand as a result of his father's behavior. Respondent wrote alternating prescriptions for methadone, dolophine, and morphine for J.B. from December of 1991 through mid-June 1993. He remained on the same dosage. When seen in the community, J.B. was clean, spoke coherently, walked in a straight line, and dressed appropriately for Key West. Although the mixture of prescriptions and the dosage amounts Respondent prescribed for J.B. were substantial, her prescribing practices for J.B. were within the federal Agency guidelines and were appropriate. Respondent treated P.P. from 1986 through 1993 for severe sinusitis. P.P. also developed severe low back pain (sciatica). Respondent took a back x- ray, administered physical therapy, and referred P.P. to a hypnotist. Respondent wrote on prescriptions which she gave to P.P. that her diagnosis was a herniated disc. Respondent started her on dilaudid, 2 mg., in February 1992 and continued that regimen through January 1993. She also prescribed percoset and valium, 5 mg., for the severe back pain and muscle spasm. She also prescribed an anti-inflammatory for the stomach upset resulting from the narcotic. Respondent's prescribing practices as to P.P. were within the federal Agency's guidelines and were appropriate. In her treatment and prescribing practices for L.P., J.P., M.G., C.D., J.B., and P.P., Respondent kept detailed records, in part due to her concern that she might become the subject of criticism by Petitioner. Such records were not, however, offered at hearing by either party. The prescribing of controlled substances to the patients involved in this proceeding was done in the course of Respondent's professional practice.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent not guilty and dismissing the Administrative Complaint filed against her in this cause. DONE and ENTERED this 1st day of June, 1995, at Tallahassee, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 1st day of June, 1995. APPENDIX TO RECOMMENDED ORDER Petitioner's proposed findings of fact numbered 1-3 and 22 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed findings of fact numbered 4-21, 23, and 24 have been rejected as not being supported by the weight of the credible evidence in this cause. Respondent's fifth unnumbered paragraph has been adopted either verbatim or in substance in this Recommended Order. Respondent's fourth unnumbered paragraph has been rejected as being irrelevant to the issues involved herein. Respondent's first, second, third, sixth, and seventh paragraphs have been rejected as containing only argument. COPIES FURNISHED: Steven Rothenburg, Esquire Agency for Health Care Administration Suite 210 9325 Bay Plaza Boulevard Tampa, Florida 33619 Katherine Anne Hoover, M.D. Route 2 Box 203 Lost Creek, West Virginia 26385 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0770 Tom Wallace, Assistant Director Agency for Health Care Administration Suite 301 The Atrium 325 John Knox Road Tallahassee, Florida 32303
The Issue The issues to be decided are whether Respondent violated portions of chapter 458, Florida Statutes, as alleged in the Administrative Complaints; and, if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to this matter, Dr. Mubang was a licensed physician within the State of Florida, having been issued license number ME55171. Respondent’s address of record is 741 Martin Luther King Boulevard West, Seffner, Florida 33584. Since at least March 17, 2010, Dr. Mubang’s practice at 741 Martin Luther King Boulevard has been registered as a pain management clinic with Petitioner. Dr. Mubang is board-certified in geriatric medicine and ambulatory medicine. Dr. Mubang immigrated to the United States from Cameroon, West Africa, to obtain his college education at State University of New York-Buffalo (“SUNY-Buffalo”). Dr. Mubang received a bachelor of arts degree in biology from SUNY-Buffalo. Dr. Mubang attended medical school at Southwestern University School of Medicine in the Philippines. Upon completion of his medical education, Dr. Mubang attended the Medical College of Pennsylvania for clinical rotations. He performed his residency at State University of New York-Brooklyn and Hahnemann University. Dr. Mubang’s license was first issued June 14, 1989, and is valid through January 31, 2020. His license has not been the subject of prior discipline. Dr. Mubang has maintained his Drug Enforcement Agency (“DEA”) Certificate of Registration without revocation, suspension, or other sanction. He has additionally qualified for, and obtained, a separate DEA Certificate of Registration to dispense Suboxone and buprenorphine. This secondary DEA Certificate of Registration requires training in addiction medicine. Dr. Mubang has continuously practiced as the primary care physician for many of his patients. He began his practice in Florida with CIGNA Health Group in one of its managed care clinics at University Mall in Tampa. When CIGNA closed its clinics, Dr. Mubang became employed by Correctional Medical Services (“CMS”), initially at Lake Correctional Facility, and then as the medical director for the Hillsborough County Sheriff’s Office. During his tenure with the Hillsborough County Sheriff’s Office, Dr. Mubang was recognized as the “Medical Director of the Year” for CMS in 1998. After leaving the Hillsborough County Sheriff’s Office, Dr. Mubang joined a practice with Dr. Encarnacion in Seffner, Florida. When Dr. Encarnacion retired, Dr. Mubang acquired the practice. In May 2009, Dr. Mubang received from the Board of Medicine and the Department of Health a publication entitled, “responsible opioid prescribing.” Dr. Mubang learned through his participation in various continuing medical education seminars about certain forms recommended for the treatment of patients suffering from chronic pain. He did not use electronic medical records prior to the dates of treatment charged in these consolidated Administrative Complaints. While in private practice, Dr. Mubang continued to treat patients committed to the State of Florida Juvenile Assessment Centers in Pasco, Pinellas, Sarasota, and Manatee counties. Dr. Mubang’s practice was licensed as a pain management clinic in 2010, despite his having limited formal training or education in pain management. Since initial licensure, his pain management clinic has remained continuously in operation, and has consistently passed all inspections. Pain Management Clinics are subject to annual inspections by DOH pursuant to section 458.3265(4)(a). Dr. Mubang’s Pain Management Clinic has never failed an inspection. DOH Investigator Victor Troupe of the Investigative Services Unit performed inspections of Dr. Mubang’s clinic. The clinic passed inspection. Dr. Mubang’s charged treatment of Patients A.M., B.B., C.C., W.B., and M.H., as alleged in the Administrative Complaint, occurred prior to October 17, 2010, the effective date of revised rule 64B8-9.013. Both parties presented expert witnesses board-certified in pain management to testify as to the standard of care required in this matter. Dr. Robert Guskiewicz testified as a medical expert for Petitioner. Dr. Guskiewicz is board-certified by the American Board of Anesthesiology in anesthesiology with a subspecialty in pain medicine. Dr. Guskiewicz practices as part of a large multispecialty practice in Gainesville, Florida, called Southeast Integrated Medical (“SIMED”). SIMED’s practice areas include neurology, neurosurgery, rheumatology, gynecology, psychology, urology, physiatry, allergy, family practice, and internal medicine. Dr. Guskiewicz is not now, and never has been, a primary care physician. About 40 percent of Dr. Guskiewicz’s practice is performing injections or interventions on patients. Most of the balance is patients on medication management seeking to achieve better functionality. Dr. Guskiewicz defines the standard of care as “what a prudent physician would do with a particular patient in a particular situation at that particular time.” In his practice, Dr. Guskiewicz prescribes 30 mg of oxycodone. Oxycodone is an effective pain medication. According to him, there is no maximum recommended dose for 30 mg of oxycodone. For the purposes of his expert testimony, Dr. Guskiewicz has no knowledge or information regarding Dr. Mubang or his practice. He does not know how big the clinic is where Dr. Mubang practices, who owns it, how many patients are seen each day, how many employees work there, or the types of patients treated there. Dr. Guskiewicz was paid an hourly fee for his expert testimony and preparation for deposition in this matter. Dr. Guskiewicz testified that he did a page-by-page review of the medical records he initially reviewed and those provided for his deposition in lieu of live testimony. Dr. Guskiewicz testified that the records were identical for Patients A.M., B.B., W.B., and M.H., but that the Bates numbers for the records for Patients C.C. and B.D. were not in sync. For Patient B.B., it was apparent at the hearing that Dr. Guskiewicz was in possession of the requisite records, which Respondent argued, had not been reviewed. For Patient M.H., Dr. Mubang argued that Joint Exhibit 6, covering records of treatment from 2010-2012, was not reviewed by Dr. Guskiewicz. Dr. Guskiewicz testified that the records for Patient M.H. were identical. In any event, the records subject to Respondent’s objection concern treatment after the treatment dates at issue in the Administrative Complaint. Only the records concerning the allegations contained in the Administrative Complaints will be considered for purposes of this Recommended Order. Dr. Mubang also raised the issue that Dr. Guskiewicz was not a similarly situated practitioner to Respondent. Dr. Mubang self-identified as practicing in pain management, and he owned and operated a clinic that was registered as a pain management clinic with DOH. Each patient treated by Dr. Mubang signed an Attestation for Pain Management, along with an Agreement for Treatment with Controlled Substances Therapy for Pain. Dr. Mubang acknowledged that if he gave a patient a pain management agreement, he was providing pain management to that patient. If a health care provider is providing evaluation, treatment, or diagnosis for a condition that is not within his or her specialty, a specialist trained in the evaluation, treatment, or diagnosis for that condition shall be considered a similar health care provider, pursuant to section 766.102(8), Florida Statutes. Because Respondent’s care at issue in this case is pain management, which is not specifically within his specialty, Dr. Guskiewicz is considered a similarly situated practitioner to Respondent. Petitioner did not provide Dr. Guskiewicz with any deposition testimony in this action until after his deposition in lieu of live testimony on October 9, 2018. Consequently, the depositions were not considered at the time Dr. Guskiewicz prepared his reports in this action. Dr. Guskiewicz never interviewed any of the patients at issue in this matter; never conducted any physical examination of the patients; and does not know where any of these patients are today. Further, he does not know what their current condition is; whether any of the patients are still receiving treatment for chronic pain; and whether any of the patients are still receiving opioid pain medications for the treatment of chronic pain. During the time periods relevant to these consolidated actions, Florida did not have a prescription drug monitoring database or E-FORCSE. At the time Dr. Guskiewicz authored his November 29, 2011, report, there was not a prescription drug monitoring database in Florida to permit practitioners to verify a patient’s representations about the medications they were taking and who had prescribed them. Dr. Guskiewicz is not a primary care physician, and has never been called upon to cover for a primary care physician who is treating a patient and has an ongoing relationship with that patient. Dr. Guskiewicz agrees that physicians in Florida have an obligation to consider their patients’ subjective complaints of pain and to treat them. Dr. Guskiewicz defines pain management as “treating patients who have chronic pain and provide different modalities of care to increase the functionality and well-being within that patient.” The goal of pain management is to optimize the patient’s functionality, lifestyle, and well-being within his or her family and community. Dr. Guskiewicz acknowledged that a patient coming to him for medical management of his or her pain is looking for an increase in function so he or she can get back to work and participate in normal activities of daily living. Dr. Guskiewicz defines intractable pain as “pain that perpetuates itself no matter what modalities are tried and will always be there. It’s now thought of being a more centralized pain that is basically within the brain itself.” Dr. Thomas Simopoulos testified as a medical expert for Respondent. Dr. Simopoulos is board-certified by the American Board of Anesthesiology in anesthesiology with a subspecialty in pain medicine. Dr. Simopoulos testifies as an expert for the defense more than 90 percent of the time. In the last five years, Respondent’s counsel has paid Dr. Simopoulos $30,000 to $50,000 in expert witness fees. Dr. Simopoulos lives in and practices medicine in Massachusetts. Dr. Simopoulos is not licensed to practice medicine in any other state; and he has never practiced medicine in the State of Florida. Dr. Simopoulos testified that the standard of care at the time material to this case was more regional than national. Dr. Simopoulos educated himself about the regional standard of care in Florida through conversations with his students and through hearing from people at national meetings. Dr. Simopoulos testified that patients have the right to reject a surgical recommendation: “Patients who are younger, in their more productive years, may not want to seek out surgery as a solution, particularly of the spine because it usually means that they’re at risk for having multiple surgeries. So and that even continues today, we try to manage younger folks with more conservative measure [sic], including medications to try to avoid surgery, because we know where that trajectory is going to go.” Dr. Simopoulos admitted that there were no studies at the time material to this case that revealed the exact nature and course of practice in the State of Florida. While Dr. Simopoulos is credited as an expert in anesthesiology and pain management, his reliance on the second- hand accounts from students and conferences he attended to form his opinions about the regional standard of care in Florida, are not as persuasive as the accounts of Dr. Guskiewicz, a physician practicing in the area of anesthesiology and pain management in Florida. Accordingly, Dr. Guskiewicz’s testimony is entitled to greater weight in this proceeding. Dr. Simopoulos also opined that the standard of care can only be violated when a patient is harmed. DOH argued that his definition is inconsistent with the definition in Florida law as contained in section 766.102(1). DOH Investigator Victor Troupe served a subpoena on September 2, 2010, for patient records to include: A.M., B.B., C.C., M.H., and W.B. Investigator Troupe took possession of the original files on that date. He has no reason to believe those patient files had been altered in any way. Investigator Troupe had performed numerous annual inspections of Dr. Mubang’s clinic, and neither found any violations or issued any citations. Investigator Troupe never interviewed Patients A.M., B.B., C.C., M.H., W.B., or B.D. Further, Investigator Troupe has no knowledge or information regarding the present whereabouts of any of those individuals. Finally, he has no information about whether those patients are still receiving opioid analgesic pain medication, even though DOH has access to E-FORCSE for investigative purposes. Drug Definitions Oxycodone is commonly prescribed to treat pain. Roxicodone is a brand name for oxycodone. Oxycodone is a Schedule II controlled substance. Oxycodone will be used throughout this Order, even if the brand name Roxicodone was prescribed. All Schedule II controlled substances have a high potential for abuse and have currently accepted, but severely restricted, medical use in treatment in the United States. Abuse of Schedule II controlled substances may lead to severe psychological or physical dependence. § 893.03(2), Fla. Stat. Fentanyl is a very strong opioid that is prescribed to treat pain and is listed as a Schedule II controlled substance. § 893.03(2)(b), Fla. Stat. Hydromorphone is a Schedule II controlled substance that is commonly prescribed to treat pain. Hydromorphone is commonly prescribed under the brand name Dilaudid. § 893.03(2)(a), Fla. Stat. Methadone is a synthetic opioid prescribed to treat pain. Methadone is a Schedule II controlled substance. § 893.03(2)(b), Fla. Stat. Vicodin and Lortab are brand names for hydrocodone/APAP. Hydrocodone/APAP contains hydrocodone and acetaminophen and is prescribed to treat pain. Hydrocodone in the dosages found in Vicodin is a Schedule III controlled substance. § 893.03(3)(c)4., Fla. Stat. All Schedule III controlled substances have a potential for abuse less than the substances in Schedules I and II. Abuse of Schedule III controlled substances may lead to moderate or low physical dependence or high psychological dependence. § 893.03(3), Fla. Stat. Fiorinal with codeine is the brand name for a drug that contains butalbital and codeine and is commonly prescribed to treat migraine headaches. Butalbital is a Schedule III controlled substance. Codeine is commonly prescribed to treat pain. Codeine is a Schedule II controlled substance. § 893.03(3)(a) and (2)(a), Fla. Stat. Ultram is a brand name for tramadol, an opioid-class narcotic medication prescribed to treat pain. At the time of the events of this case, tramadol was not a controlled substance. Tramadol is currently a Schedule IV controlled substance. § 893.03(4)(b), Fla. Stat. (2018). All Schedule IV controlled substances have a low potential for abuse relative to the substances in Schedule III. Abuse of Schedule IV controlled substances may lead to limited physical or psychological dependence relative to the substances in Schedule III. § 893.03(4), Fla. Stat. Soma is the brand name for carisoprodol. Carisoprodol is a muscle relaxant commonly prescribed to treat muscular pain. Carisoprodol is a Schedule IV controlled substance. § 893.03(4), Fla. Stat. Adderall is the brand name for a drug that contains amphetamine. Adderall is commonly prescribed to treat attention deficit disorder (“ADD”). Adderall is a Schedule II controlled substance. § 893.03(2)(c), Fla. Stat. Xanax is the brand name for alprazolam. Klonopin is the brand name for clonazepam. Valium is the brand name for diazepam. All three drugs are benzodiazepine-class drugs prescribed to treat anxiety, and all three drugs are Schedule IV controlled substances. During the time Respondent treated the five patients, who are the subject of the DOH Case No. 2010-12384, Florida did not have a prescription drug monitoring database. Before E-FORCSE, practitioners had to rely upon a patient’s representation regarding his or her medication history and verify the information by calling identified pharmacies. This “trust but verify” policy was in place at Dr. Mubang’s practice. During the time of Dr. Mubang’s treatment of these patients, he received a letter from Ana M. Viamonte Ros, M.D., the surgeon general for the State of Florida, and Fred Bearison, M.D., the chairman of the Florida Board of Medicine, dated May 13, 2009. That letter enclosed a copy of Responsible Opioid Prescribing, A Physician’s Guide, written by Scott M. Fishman, M.D. The letter advised Dr. Mubang, and others similarly situated, that Dr. Fishman’s book “is a practical guide to Florida’s current standards for the use of controlled substances for the treatment of pain,” based upon the Federation of State Medical Board’s Model Rule, “so it is right on point for Florida practicing doctors.” The book also stated, at page 25: Although Medicare and other institutions have defined what constitutes a physical examination for purposes of coding and reimbursement, exactly what comprises an appropriate or acceptable physical examination for pain is not well-defined, largely because it will differ from case to case. Regulators who expect to see a physical examination as part of the evaluation that leads to appropriate pain care involving controlled substances assume that a basic, if not focused, examination is warranted. The exact components of the examination are left to the judgment of the clinician who is expected to have performed an examination proportionate to the diagnosis that justifies a treatment. Dr. Mubang testified at the hearing, “many point-of- care screens for ‘opiates’ do not reliably detect any opioid other than codeine and morphine, or may not report if levels are below a certain threshold. Therefore, they may give false negative results for semisynthetic and synthetic oil opioid analgesics.” Dr. Mubang received feedback from pharmacists and patients regarding limitations on prescribing imposed on distributors and pharmacies by the DEA, including during the fall of 2010. During the time Dr. Mubang treated the six patients subject to these consolidated administrative actions, there was no upper limit recommended or identified regarding the maximum dosage for opioid analgesics. New patients to Dr. Mubang’s practice have to fill out paperwork, including a patient history. Patients were also required to sign an opioid contract, which mandated patients to use only one pharmacy and required that the patient only obtain medication from Dr. Mubang. Dr. Mubang obtained authorizations for release of medical information to acquire records of prior treating physicians. His office consistently obtained prior records, including MRIs and other diagnostic studies. Dr. Mubang testified that he performed a physical examination of each patient on each office visit. The initial exam was broad, while follow-up examinations were focal. His physical examinations included a review of systems, from head to toe. He stated that each physical examination included a review of the patient’s neurological status and notes whether the patient is oriented to person, time, and place. Dr. Mubang’s practice was to observe patients in his waiting room, and watch each patient as they come to the exam room. This observation is intended to identify things like gait abnormalities, guarding, and posture. Pain patients in Dr. Mubang’s practice are required to complete a Brief Pain Inventory, which he reviews with each patient. Dr. Mubang also reviews past medications with each patient to determine whether the medication has been effective in relieving pain and increasing activities of daily living. He reviews with each patient potential side effects of medication and the risks and benefits of using those medications. Dr. Mubang prepares a progress note for each office visit with a patient. Additionally, he maintains copies of each prescription issued to a patient. The identified treatment plan for each of these six patients was to improve the patient’s functional abilities, to allow them to return to work, and to participate in relationships. Dr. Mubang periodically required patients to submit to a urine immunoassay. This is a presumptive screening test for illicit substances and some other controlled substances. As Dr. Fishman points out on page 61 in his book Responsible Opioid Prescribing, Dr. Mubang was aware that “point-of-care screens for opioids do not reliably detect any opiate other than codeine and morphine.” During the 2010 timeframe, a physician who ordered a urine drug screen was not required to do anything with the results. Further, the requirements of rule 64B8-9.013(3)(d) to monitor patient compliance were not mandatory until after October 17, 2010. Dr. Mubang is aware of the sedative effects of opioids taken with muscle relaxants like Soma. This combination of medication should be dispensed with caution, but if a patient has been taking it for a period of time with no problems, he believes the prescription is appropriate. Dr. Mubang’s approach to changing pain medication, as explored more fully in the following discussion of the six patients subject to this proceeding is consistent, but deserves close scrutiny. He testified that: If the vital signs are stable, you can do what you want, so long as it doesn't have consequences. If you see the visit after this, this patient did not come in with hypertension or they did not end up in the hospital or I was not called at 2:00 in the morning. So it tells you what you're doing is right. See? That's why we do these vital signs. The Patients Each of the patients in this cause completed a two-page questionnaire about his or her pain, titled “brief pain inventory,” during each visit after the initial visit. The pain inventory contained: an anatomical figure for the patient to mark painful areas, 12 questions with a one-to-ten scale for pain level and for activities of daily living, and spaces for the patient to describe the pain in writing. Dr. Mubang’s progress notes for each of the patients consisted of a printed form, containing a similar anatomical figure at the top of the page with most of the rest of the page containing a checklist for “assessment.” Patient A.M. From December 22, 2009, to October 20, 2010, Dr. Mubang provided pain management treatment to Patient A.M., a then 23-year-old female, for lower back pain related to a car accident that occurred several years earlier. Dr. Mubang had first begun treating Patient A.M. while covering for Dr. Luis Azan at Plant City Polyclinic, where he prescribed her 240 30 mg tablets of oxycodone and 120 10 mg tablets of methadone. Dr. Mubang noted that Patient A.M. had been a passenger in the back of the car and was wearing a seatbelt. He noted that Patient A.M. did not lose consciousness, and while she went to the emergency room, she did not have an in-patient stay. On her initial evaluation questionnaire, Patient A.M. reported trying four alternative treatment methods for her pain out of 18 possible treatment options on Dr. Mubang’s checklist form: chiropractic treatment (no relief); muscle injections (no relief); massage (no relief); and pain relievers (some relief). By her own report, Patient A.M. had not tried physical therapy, nerve blocks, or surgery. Patient A.M. had sequential MRI findings from November 7, 2007 (ordered by Dr. Murthy Ravipati), and March 23, 2010 (ordered by Dr. Mubang), which demonstrated a central focal disc protrusion (herniated nucleus pulposus) at L5-S1. On her first visit at his office, Dr. Mubang increased Patient A.M.’s oxycodone from 240 to 270 30 mg tablets per month. He failed to document a rationale for the 30-pill increase. Dr. Mubang’s medical records included Patient A.M.’s medical history and physical examination; diagnostic, therapeutic, and laboratory results; evaluations and consultations; objectives identified; risks and benefits of the treatment ordered; treatments and medications ordered and documented; and instructions and agreements regarding pain management. Dr. Mubang made referrals to consulting physicians, including Dr. Goldsmith (orthopedic) and physical therapy (Select Physical Therapy). From December 22, 2009, to August 27, 2010, Dr. Mubang prescribed 270 30 mg tablets of oxycodone in combination with 120 10 mg tablets of methadone to Patient A.M. monthly. In ten months, Patient A.M. received 3,870 pain pills from Dr. Mubang. In order to take the pain medication as prescribed, Patient A.M. would have to take 13 pain pills per day. By comparison, Dr. Mubang’s expert, Dr. Simopoulos, testified that in his practice the most 30 mg of oxycodone that he ever prescribed was six tablets per day, or 180-200 tablets per month. Petitioner’s expert, Dr. Guskiewicz, testified that in his practice the most 30 mg of oxycodone that he ever prescribed was five per day, or 150 tablets. In addition to the pain medication, Dr. Mubang prescribed 90 350 mg tablets of Soma to Patient A.M. per month. On August 2, 2010, Dr. Mubang ordered a urine drug screen for Patient A.M. The drug screen was positive for benzodiazepines and negative for methadone. If a patient tests negative for a prescribed medication, the physician should consider the possibility that the patient is not taking the drug and, instead, is diverting it. Given Patient A.M.’s negative test for methadone, Dr. Mubang should not have continued to prescribe methadone to her, or at least should have questioned her about her usage of the prescribed drug. Despite the aberrant test result, Dr. Mubang continued to prescribe potentially lethal doses of oxycodone, methadone, and Soma to Patient A.M. Further, from December 22, 2009, through August 27, 2010, Dr. Mubang did not perform nor did he document performing a complete and adequate physical examination or medical history to justify his prescribing of potentially lethal doses of methadone, oxycodone, and Soma to Patient A.M. From December 22, 2009, through August 27, 2010, Dr. Mubang did not diagnose Patient A.M. with intractable pain prior to prescribing potentially lethal doses of methadone, oxycodone, and Soma to Patient A.M. To meet the standard of care, Dr. Mubang should have immediately reduced the amount of medication that he prescribed to Patient A.M. Additionally, he should have tried to determine the root cause of Patient A.M.’s pain. Dr. Mubang should have followed up on his ordering of alternative treatment modalities, such as physical therapy, and if Patient A.M. refused to follow his instructions, he should have discharged Patient A.M. While Dr. Mubang’s records are at times difficult to read, some were legible enough for review by the two experts who offered opinions in this matter. On the whole, however, the medical records for Patient A.M. were inadequate (and some of them were actually illegible) to provide complete information to either Dr. Mubang or another reviewing physician or investigator. Patient B.B. From March 25, 2010, to August 23, 2010, Respondent provided pain management treatment to Patient B.B., a then 25- year-old female. Patient B.B. initially visited Dr. Mubang on March 25, 2010, with a history of cervical spinal fusion in 2003 following a motor vehicle accident. Dr. Mubang’s Initial Evaluation documented a thorough review of systems, including skin; HEENT (head, eyes, ears, nose, and throat); neurological; and musculoskeletal. Simultaneously, Dr. Mubang and the patient completed a Pain Questionnaire documenting the location and severity of Patient B.B.’s pain and other treatment modalities, which had been tried, but failed (surgery, braces, chiropractic, physical therapy, TENS, and massage). On her initial visit with Dr. Mubang, Patient B.B. reported having neck, shoulder, and upper back pain. Dr. Mubang noted on his initial range of motion assessment that Patient B.B. had no thoraco-lumbar spine pain. Patient B.B. never indicated on her brief pain inventories that she had pain radiating down the leg. Instead, she consistently marked pain in the neck, radiating down the right arm, and pain in the middle back. After the initial visit, Dr. Mubang recorded that Patient B.B. had lower back pain by noting “LBP & radiculopathy” with a line drawn down the leg of the anatomical figure. Dr. Mubang’s explanation for the discrepancy between his notation on the anatomical figure and Patient B.B.’s notation was that the patient was noting pain, but that he was noting tenderness. He did not explain the difference. As discussed below, this same inconsistency appears frequently in many of the patients’ records. Dr. Mubang’s offered explanation for the discrepancy between his records and the patient-generated records is not credible. From March 25, 2010, to August 23, 2010, Dr. Mubang prescribed 240 30 mg tablets of oxycodone in combination with 60 2 mg tablets of Xanax to Patient B.B. monthly. From March 25, 2010, to May 20, 2010, Dr. Mubang also prescribed 120 350 mg tablets of Soma to Patient B.B., in addition to the oxycodone and Xanax each month. To justify the amount of Xanax he prescribed to Patient B.B., Dr. Mubang relied on an anxiety checklist questionnaire completed by Patient B.B. In his practice, if a patient marked five to six of the criteria on his anxiety checklist, Dr. Mubang would prescribe the patient Xanax. For Patient B.B., on three of his five progress notes, Dr. Mubang checked the box for anxiety. Other than that, there is no annotation or documentation by Dr. Mubang concerning Patient B.B.’s anxiety. From March 25, 2010, through August 23, 2010, based on Patient B.B.’s history and physical findings, Dr. Mubang prescribed potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. in excessive quantities and without sufficient justification. From March 25, 2010, through August 23, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing of potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. From March 25, 2010, through August 23, 2010, Dr. Mubang failed to diagnose Patient B.B. with an anxiety disorder, which would have supported his prescribing of Xanax to Patient B.B. From March 25, 2010, through August 23, 2010, Dr. Mubang did not diagnose Patient B.B. with intractable pain prior to prescribing potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. To meet the standard of care, Dr. Mubang should have done more to treat Patient B.B.’s underlying source of pain through referrals for physical therapy or orthopedics. Depending on the particular findings, he should have tried intervention care to relieve Patient B.B.’s pain instead of relying solely on medication management, particularly, excessive amounts of oxycodone. Patient B.B., as a relatively young patient, would have benefited from more aggressive physical therapy, massage therapy, and other treatment modalities to keep her off of addictive pain medication as much as possible. Dr. Mubang attempted, in part, to justify his excessive amounts of medications, based upon The Super Saver pharmacy profile for Patient B.B., which confirms that this patient was receiving the same quantities and combination of medications from the prior physician, Ibem R. Borges, M.D. He also cites rule 64B8-9.013 (2003) to support the heavy prescribing of medications, which indicates the Board of Medicine will not judge the validity of prescribing, “based upon the quantity and chronicity,” and that a “physician’s conduct will be evaluated to a great extent by treatment outcome.” He argues that Petitioner failed to introduce any evidence to establish Patient B.B. suffered any adverse effect from Dr. Mubang’s treatment. Patient C.C. From April 29, 2010, to May 28, 2012, Dr. Mubang provided pain management treatment to Patient C.C., a then 32-year-old female. At her initial evaluation, Patient C.C. reported having lower back pain and left knee pain. On her subsequent brief pain inventories, Patient C.C. consistently marked pain at the middle of the lower back and pain at the left knee. Almost identical to Patient B.B., Dr. Mubang’s progress notes for Patient C.C. note “LBP & radiculopathy” with a line drawn down the leg of an anatomical figure indicating pain radiating down the leg. Contained in Respondent’s records were notes from two prior treating providers, Drs. David Herson and Marc Weinstein. On a note dated February 27, 2007, Dr. Herson noted that Patient C.C.’s cervical and lumbar range of motion was within normal limits, and he noted no tenderness to palpation of the lumbar spine. Dr. Herson recommended epidural injections to Patient C.C. for the left knee pain. Dr. Herson prescribed Patient C.C. 30 tablets of Ultram for her pain. On a note dated March 1, 2007, Dr. Weinstein noted that “MRI scans of her cervical and lumbar spine and left knee were performed and show no significant abnormalities that would require surgery.” From April 29, 2010, to August 19, 2010, Dr. Mubang prescribed 290 30 mg tablets of oxycodone in combination with 180 10 mg tablets of methadone to Patient C.C. monthly. In a period of four months, Patient C.C. received 2,350 pain pills from Dr. Mubang, which equates to a daily prescription of 15.5 pills. In addition to addictive pain medication, Dr. Mubang also prescribed 60 2 mg tablets of Xanax to Patient C.C. per month. Opioids and benzodiazepines in combination increase the risk of respiratory depression, which can be fatal. On April 29, 2010, and May 27, 2010, Dr. Mubang added 90 350 mg tablets of Soma to the potentially lethal cocktail of medications he prescribed to Patient C.C. Dr. Mubang failed to document his rationale for starting and stopping Soma. On April 29, 2010, as part of her initial evaluation with Dr. Mubang, Patient C.C. reported to him that her current medications were oxycodone, methadone, Xanax, and Soma. On April 29, 2010, Dr. Mubang ordered a urine drug screen for Patient C.C. The drug screen was positive for opiates, oxycodone, and benzodiazepines, but was negative for methadone. Opiates and opioids are discernibly different categories of drugs. Opiates are morphine derivatives. Opioids are synthetic opiates. No medications Patient C.C. reported taking were opiates. The standard of care required Dr. Mubang to inquire as to the reasons behind the aberrant drug test result and adjust Patient C.C.’s medications accordingly. In his 2012 deposition, Dr. Mubang speculated that he may have consulted Patient C.C. about the drug test and that maybe she ran out of medication. He could not tell from his records if he discussed the results with Patient C.C. or the reason for the aberrant test result because his records lacked any such information. At the final hearing in this matter, Dr. Mubang raised for the first time the defense that the urine drug screen he used at that time was incapable of testing for methadone. He also argued that if a patient is taking oxycodone and methadone together, then either one, both, or neither may show up positive on a urine drug screen due to “tolerance” and methadone’s interaction with oxycodone and with the NMDA (the amino acid neuro receptor that increases the tolerance of oxycodone by interacting with methadone). This was a clear misunderstanding by Dr. Mubang of his expert’s testimony regarding the use of methadone in pain management. Dr. Mubang testified many times at hearing that methadone has a tolerance effect on oxycodone, which causes a physician to increase the dose of oxycodone. Respondent’s testimony was incongruent with the description given by his expert witness. Dr. Simopoulos explained that methadone can antagonize NMDA receptors, which can help some patients who have a tolerance to oxycodone. However, Dr. Simopoulos’s testimony regarding NMDA did not relate to the ability to detect methadone in a urine drug screen. Despite the negative test result for methadone, during the same visit, Dr. Mubang prescribed 180 10 mg tablets of methadone to Patient C.C. No questions of whether Patient C.C. may have diverted her methadone or notations of such were in the doctor’s notes. Dr. Mubang failed to order a second urine drug screen for Patient C.C. until ten months later on February 2, 2011. The second test was also negative for the prescribed medication methadone. From April 29, 2010, through August 19, 2010, based on Patient C.C.’s presentation, Dr. Mubang prescribed potentially lethal doses of oxycodone, methadone, Xanax, and Soma to Patient C.C. inappropriately, in excessive quantities, and without justification. From April 29, 2010, through August 19, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing potentially lethal doses of oxycodone, methadone, Xanax, and Soma to Patient C.C. Dr. Mubang did not diagnose Patient C.C. with intractable pain prior to prescribing to the patient the potentially lethal doses of oxycodone, methadone, Xanax, and Soma. To meet the standard of care, Dr. Mubang should not have prescribed such large amounts of pain medication to Patient C.C., a patient who did not have a significant pathology for pain. Instead, he should have pursued other treatment modalities, such as injections and physical therapy. Patient W.B. From December 13, 2008, to February 18, 2011, Dr. Mubang provided pain management treatment to Patient W.B., a then 52-year-old male. On or about April 20, 2008, prior to visiting Dr. Mubang, Patient W.B. presented to the emergency room at Sarasota Memorial Hospital after being hit by a “slow moving vehicle,” while riding his bicycle. The emergency room physician diagnosed Patient W.B. with a bruise of the left knee and left hip and prescribed an unknown quantity of 7.5 mg Lortab to Patient W.B. Patient W.B. then visited Physician’s Group, LLC, in Sarasota for follow-up care on April 20, May 28, November 11, and December 2, 2008. On May 28, 2008, Patient W.B. reported to a provider at Physician’s Group, LLC, that he had taken Dilaudid from a friend. On November 11, 2008, Patient W.B. saw Dr. Frederic Sonstein. Dr. Sonstein noted that Patient W.B. missed a scheduled appointment because he was incarcerated. While incarcerated, Patient W.B. was treated with Flexeril and Ultram. Dr. Sonstein recommended referral to a pain management specialist and prescribed Vicodin for pain control. A November 24, 2008, MRI report of Patient W.B.’s lumbar spine was unremarkable. On December 13, 2008, Patient W.B. came to Dr. Mubang and reported having pain in his neck and shoulders, with pain radiating down both arms. In contrast to Patient W.B.’s report, on his initial range of motion evaluation, Dr. Mubang did not document any findings under cervical spine. Instead, he noted lumbar spine pain with radiculopathy. On his initial evaluation questionnaire, Patient W.B. reported only having tried one alternative treatment method for his pain, “braces or cast.” By his own report, Patient W.B. had not tried any of the other alternative treatment options on Dr. Mubang’s checklist form, such as physical therapy, chiropractic, muscle injections, or surgery. Despite the minimal objective findings in Patient W.B.’s history, Dr. Mubang began to prescribe escalating amounts of oxycodone to Patient W.B. On December 13, 2008, Dr. Mubang prescribed 120 30 mg tablets of oxycodone to Patient W.B. Then, he increased the amount of oxycodone he prescribed to Patient W.B. over the following monthly visits as follows: 150, 180, 210, 210, 240, 240, and ultimately settling at 270 30 mg tablets of oxycodone per month. From December 13, 2008, to August 24, 2010, Dr. Mubang prescribed Patient W.B. 4,050 30 mg tablets of oxycodone. On July 11, 2009, in addition to oxycodone and Soma, Dr. Mubang added Xanax and Fiorinal with codeine to Patient W.B.’s monthly prescription regimen. Like with Patient B.B., Dr. Mubang prescribed Xanax to Patient W.B. based on Patient W.B.’s answers to his checklist anxiety questionnaire. On July 11, 2009, Dr. Mubang saw Patient W.B. and renewed his medication. He scheduled Patient W.B. to return on August 9, 2009; however, Patient W.B. missed the appointment. Patient W.B. next visited Dr. Mubang two months later, on October 13, 2009. Dr. Mubang failed to document the reason for Patient W.B.’s three-month absence. He failed to document if Patient W.B. continued to receive pain medication from another source. He did not note whether Patient W.B. experienced withdrawal symptoms without his oxycodone for two months or how Patient W.B. managed his pain without oxycodone for two months. Dr. Mubang admitted during the hearing that, “[i]t is important to me to know why he misses visits. And you're right. Your point is well-taken.” Dr. Mubang’s own controlled substance agreement, which was executed by Patient W.B., explicitly stated that renewals are contingent on keeping scheduled appointments. Despite the unexplained absence, on October 13, 2009, he renewed Patient W.B.’s prescriptions for 270 tablets oxycodone, 30 tablets Soma, 60 tablets Xanax, and 90 tablets of Fiorinal with codeine. Dr. Mubang should not have restarted Patient W.B. at the same high dosage of oxycodone that he had previously prescribed, as it was potentially fatal. On November 10, 2009, Dr. Mubang ordered a urine drug screen for Patient W.B. The drug screen was positive for cocaine and hydromorphone. The drug screen was negative for the prescribed medications Soma (carisoprodol) and Xanax (alprazolam). Based upon the November 10, 2009, drug screen result, the standard of care required Dr. Mubang to refer Patient W.B. to a drug treatment center. When questioned about the positive cocaine result, Dr. Mubang’s expert, Dr. Simopoulos, testified, “That’s the part where this patient has a substance abuse disorder, obviously.” Dr. Simopoulos opined that, “if you are going to continue prescribing in this case, because the patient has duel diagnoses, you would want the input of a psychiatrist for this case.” Patient W.B. next visited Dr. Mubang approximately three months later on February 9, 2010. Again, Dr. Mubang failed to document the reason for the absence. At the February 9, 2010, visit, Dr. Mubang ordered a urine drug screen for Patient W.B., which returned completely negative results. After a multi-month absence and with a completely negative urine drug screen, Patient W.B. would have been opioid negative. In his 2012 deposition, Dr. Mubang theorized that the completely negative result may have been because Patient W.B. drove himself to his appointment and Dr. Mubang instructed his patients not to drive while on medication. This made little sense. Despite the completely negative result and unexplained absence, Respondent prescribed Patient W.B. 270 tablets of oxycodone, 30 tablets of Soma, 60 tablets of Xanax, and 90 tablets of Fiorinal with codeine. Again, Dr. Mubang should not have restarted Patient W.B. at the same high dosage of oxycodone that he had previously prescribed, as it was potentially fatal. Despite prescribing 270 tablets of oxycodone per month to Patient W.B., or nine pills per day, Dr. Mubang testified at hearing that, “[i]f I give them what they call ‘breakthrough medications,’ like oxycodone, all these, they'll tell you some days they take it, some days they don't take it.” Dr. Mubang was aware that Patient W.B. did not require nine oxycodone tablets per day and that the amount of oxycodone he prescribed to Patient W.B. was not justified. The foregoing pattern of unexplained absence and completely negative urine drug screen result, followed by Dr. Mubang renewing prescriptions, was repeated in November 2010. From December 13, 2008, through November 10, 2010, Dr. Mubang prescribed potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. inappropriately, in excessive quantities, and without justification. From December 13, 2008, through November 10, 2010, Dr. Mubang neither performed nor did he document performing a complete and adequate physical examination or medical history to justify his prescribing of the potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. From December 13, 2008, through August 24, 2010, Respondent did not diagnose Patient W.B. with intractable pain prior to prescribing potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. To meet the standard of care, Dr. Mubang should have discontinued prescribing the amount of medication that he prescribed to Patient W.B. based on the minimal findings in Patient W.B.’s history and the minimal changes on examination. In addition, Dr. Mubang should have referred Patient W.B. to a drug treatment center. Patient M.H. From January 10, 2005, to May 29, 2012, Dr. Mubang provided pain management treatment to Patient M.H., who first visited him as a 29-year-old female, suffering lower back pain. Prior to seeing Dr. Mubang, on March 24, 2004, Patient M.H. visited Dr. Edward Jacobson. Dr. Jacobson noted that Patient M.H. had been in a car accident on February 21, 2004, and that Patient M.H. was complaining of headaches. He prescribed 15 tablets of Vicodin to her. On January 10, 2005, Patient M.H.’s first visit with Dr. Mubang, he prescribed her 60 tablets of Vicodin. On January 21, 2005, Dr. Mubang added clonazepam and Adderall to Patient M.H.’s medication regimen. Dr. Mubang’s note for the January 21, 2005, visit does not make any mention of Patient M.H. suffering from an anxiety disorder or ADD that would justify his use of clonazepam or Adderall, save for a simple “ADD” noted in the assessment/plan portion of the form. Dr. Mubang should have referred Patient M.H. to a psychiatrist for diagnostic confirmation of ADD before automatically prescribing (or refilling) the Adderall prescription. From June 15, 2005, to March 7, 2007, Dr. Mubang prescribed Valium in combination with clonazepam to Patient M.H. monthly. Then on March 23, 2009, he discontinued clonazepam and started Patient M.H. on 90 2 mg tablets of Xanax. Dr. Mubang neglected to document a justification for prescribing Patient M.H. benzodiazepine-class drugs, or for prescribing her a combination of two different benzodiazepine- class drugs, or for the changes he made to the benzodiazepines he prescribed. On January 6, 2009, Patient M.H. reported having lower back pain from a car accident in 2003. Dr. Mubang noted that Patient M.H. was the driver of a car that was rear-ended. He also noted that Patient M.H. did not lose consciousness during the accident and did not go to the emergency room. At the January 6, 2009, visit, Patient M.H. reported trying three alternative treatment methods for her pain. By her own report, Patient M.H. had not tried any of the other 18 alternative treatment options on Dr. Mubang’s checklist form, such as physical therapy, muscle injections, or surgery. In 2009, for unexplained reasons, Dr. Mubang began significantly increasing Patient M.H.’s opioid pain medication. In January 2009, he increased Patient M.H.’s Vicodin from 60 to 90 tablets per month, then in July 2009 from 90 to 120 tablets per month. On October 19, 2009, Dr. Mubang prescribed Patient M.H. ten 50 mcg patches of fentanyl in combination with 120 tablets of Vicodin. A 50 mcg fentanyl patch is intended to last for 72 hours; so, a prescription of ten patches is intended to last one month. Fentanyl is a very strong opioid. Based on Patient M.H.’s experience with opioids, Dr. Mubang’s prescribing fentanyl to Patient M.H. was potentially lethal. On November 16, 2009, Dr. Mubang discontinued fentanyl and started Patient M.H. on 90 15 mg tablets of oxycodone, which he increased to 120 tablets the next month. Dr. Mubang prescribed the oxycodone in combination with 120 tablets of Vicodin. At hearing, Dr. Mubang could not tell from his notes and was, therefore, unable to explain his rationale as to why he prescribed fentanyl to Patient M.H., or why he discontinued the fentanyl and started Patient M.H. on oxycodone. The limited documentation that was included in Dr. Mubang’s records contradicted his course of treatment, as he routinely documented that Patient M.H.’s pain was a two out of ten with medication. From March 8, 2010, to June 28, 2010, Dr. Mubang added and then discontinued prescribing Soma to Patient M.H. His records do not contain any justification for starting Patient M.H. on Soma or for stopping Soma. On May 3, 2010, Dr. Mubang ordered a urine drug screen for Patient M.H. The urine drug screen result was negative for the prescribed medication oxycodone. The standard of care required Dr. Mubang to ask about the reason for the aberrant result to determine whether she was taking the medications or diverting them. Depending upon Patient M.H.’s answer, he should have ordered a repeat urine drug screen at the following visit. Despite the negative test, Dr. Mubang continued to prescribe potentially lethal doses of oxycodone and Vicodin to Patient M.H. From January 10, 2005, through August 23, 2010, Dr. Mubang prescribed potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone to Patient M.H. inappropriately, in excessive quantities, and without justification. From January 10, 2005, through August 23, 2010, Dr. Mubang did not diagnose Patient M.H. with ADD or any other clinical indication to support his prescribing Adderall to Patient M.H. From January 10, 2005, through August 23, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing of the potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone to Patient M.H. Dr. Mubang did not diagnose Patient M.H. with intractable pain prior to prescribing to the patient the potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone. To meet the standard of care in his treatment of Patient M.H., Dr. Mubang should not have prescribed fentanyl to Patient M.H. without sufficient medical justification, as doing so was life threatening. Respondent should have referred Patient M.H. to specialists, such as orthopedics, physical therapy, and psychiatry. To the extent Dr. Mubang documented referrals to specialists, he should have followed up on his ordering of referrals to minimize the amount of medications he provided to Patient M.H., instead of escalating the amounts of pain medicine he prescribed. Patient B.D. From November 11, 2010, to November 8, 2012, Dr. Mubang provided pain management treatment to Patient B.D., a then 24- to 26-year-old female. In addition to lower back pain, Patient B.D. was also diagnosed with fibromyalgia. Dr. Mubang’s medical records for Patient B.D. contain a note from Dr. Indira Koshy, a prior treating provider, for a visit on August 24, 2010, in New York. Dr. Koshy noted that Patient B.D. was “entering rehab” and that Patient B.D. has seizures when she does not take her medications. Dr. Koshy’s note indicates potential for doctor shopping. At no point during his treatment of Patient B.D. did Dr. Mubang address the note from Dr. Koshy, specifically; Patient B.D.’s entry into rehabilitation; Patient B.D.’s seizures when she did not take her medications; or Patient B.D.’s potential for doctor shopping. Dr. Mubang previously treated Patient B.D. at Care Point Medical Center as a covering physician. He testified that when covering as a physician he provided “continuation of care” and that his practice was not to change a patient’s medication. Despite his testimony, when covering at Care Point Medical Center, Dr. Mubang increased Patient B.D.’s oxycodone from 210 tablets per month to 240 tablets per month. Then, on November 11, 2010, when Patient B.D. visited his practice, Dr. Mubang decreased her oxycodone from 240 to 180 tablets. As discussed below, this decrease came after he received notice of Petitioner’s investigation. From November 11, 2010, until May 24, 2012, Dr. Mubang prescribed Patient B.D. 180 30 mg tablets of oxycodone, 30 or 60 10 mg tablets of methadone, 60 350 mg tablets of Soma, and 30 0.5 mg to 2 mg tablets of Xanax monthly. On June 21, 2012, Dr. Mubang changed Patient B.D.’s prescribed muscle relaxant from Soma to baclofen; and on July 19, 2012, he changed Patient B.D.’s prescribed anxiolytic medication from 60 0.5 mg tablets of Xanax to 60 2 mg tablets of clonazepam. Dr. Mubang did not document any justification for the foregoing medication changes. From September 13, 2012, until November 8, 2012, Dr. Mubang prescribed 112 8 mg tablets of Dilaudid, 28 10 mg tablets of methadone, and 60 tablets of clonazepam to Patient B.D. monthly. On June 23, 2011, Dr. Mubang performed a urine drug screen on Patient B.D. The drug screen was negative for benzodiazepines, even though he prescribed Xanax to Patient B.D. The urine drug screen was positive for methadone, despite Dr. Mubang’s testimony that his urine drug screen could not detect methadone. On December 8, 2011, and June 21, 2012, Dr. Mubang performed urine drug screens on Patient B.D. Both drug screens were negative for the prescribed medication methadone. The standard of care required a reasonably prudent physician to question the patient about the aberrant urine drug screens results and cease prescribing methadone to a patient whose urine drug screen was negative for the drug. Despite the negative test results, Dr. Mubang continued to prescribe methadone to Patient B.D. From November 11, 2010, through November 8, 2012, Dr. Mubang neither performed nor documented performing an adequate history or physical examination to justify his prescribing of the potentially lethal controlled substances to Patient B.D. From November 11, 2010, through November 8, 2012, based on Patient B.D.’s history and physical findings, Dr. Mubang’s prescribing of the controlled substances to Patient B.D. was excessive and without justification. From June 23, 2011, through November 8, 2012, Dr. Mubang failed to address Patient B.D.’s aberrant urine drug screen results. To meet the standard of care in his treatment of Patient B.D., Dr. Mubang should not have prescribed the quantity and combination of drugs he prescribed to Patient B.D. He should have referred Patient B.D. for a rheumatology consult to confirm or rule out fibromyalgia and other diseases. He should have offered more physical therapy, and other, non-opioid modalities of care, and he should have routinely followed up with Patient B.D. to ensure that she was complying with his orders. Dr. Mubang testified that Soma was part of the “holy trinity,” which is a slang drug term used to refer to the prescription combination of oxycodone, a benzodiazepine, and Soma. He prescribed the “holy trinity” to five of the six patients in this cause. Dr. Mubang’s Medical Records Dr. Mubang’s medical records for the six patients, who are the subjects of the Administrative Complaints, were generally lacking in specificity to justify the level of his prescribing. Some examples common to the patients at issue illustrate these shortcomings. For each visit for each of the patients, Dr. Mubang noted that the patient had straight leg raise pain at 30 degrees, even though he testified that a patient can have straight leg raise pain at 15, 20, 30, or 45 degrees. Maybe this was a coincidence, but more credibly it is a pattern of sloppiness or autofill by the doctor. Also, for each patient, Dr. Mubang routinely drew a line down one leg of the anatomical figure on his progress notes indicating radiculopathy, regardless of where the patient reported pain. At hearing, on multiple occasions, Dr. Mubang could not determine his rationale for changing a patient’s medication regimen, based on his progress notes. His own expert, Dr. Simopoulos, testified that, “there's not much rationale on the plans in--in Dr. Mubang's notes in general.” Dr. Mubang tried to justify the lack of documented rationale by explaining that if a subsequent treating physician needed to know why he made medication changes, the physician would just call him and ask. While this should be true in an ideal world, his attempted justification is contrary to the purpose of medical records, which is continuity of care. No doctor, regardless of his education and experience, can be expected to remember every detail about every patient when he only sees the patient periodically. The medical record and doctor’s notes comprise his guide to ensuring the patient receives continuous, appropriate care. In addition to lacking in rationale, both experts were unable to read some of Dr. Mubang’s handwritten notes due to legibility. His own expert testified that, “The hardest part about these records is, obviously, how legible they are. I wish they were more legible.” Dr. Mubang’s medical records were inadequate for all six of the patients at issue here. Dr. Mubang’s Defenses Dr. Mubang passionately testified at hearing that he practices addiction medicine, that he prescribes Suboxone, and that his goal is to titrate patients’ medication. However, Dr. Mubang’s interest in addiction medicine and Suboxone is a recent phenomenon. In his 2012 deposition, he did not mention practicing addiction medicine, and the word Suboxone does not even appear in that deposition. Dr. Mubang titrated the medication he prescribed for four of the six patients in this cause. His reasoning for titrating the patients’ medication changed from his deposition testimony to his hearing testimony. In his 2018 deposition, he testified that he reduced the patients’ pain medication because the patients’ conditions were improving, and his goal was to titrate the medication. At hearing, he asserted the theory that he changed his prescribing practices because pharmacies contacted him and told him that they would no longer fill prescriptions written for such large quantities. The first of these is based upon a consideration of quality of care, while the second is based upon the practical reality of changing pharmacy practices as the dangers of over-prescribing opiates started to become more prevalent in the eyes of health professionals and regulators. On September 2, 2010, Investigator Victor Troupe personally served Dr. Mubang with a notice of investigation and a subpoena for medical records for Patients A.M., B.B., C.C., W.B., and M.H., among others. Following receipt of the notice of investigation, the doctor radically changed his prescribing practice for the patients in this cause. For ten months, Dr. Mubang prescribed Patient A.M. 270 tablets of oxycodone. Then on September 24, 2010, three weeks after being served by Petitioner, Respondent reduced Patient A.M.’s prescription of oxycodone from 270 tablets to 210, and then from 210 tablets to 180. For five months, Dr. Mubang prescribed Patient C.C. 290 tablets oxycodone. Then on September 9, 2010, Respondent reduced Patient C.C.’s prescription of oxycodone from 290 tablets to 210. At the patient’s next visit on January 5, 2011, Dr. Mubang reduced the patient’s prescription of oxycodone from 210 tablets to 180. Dr. Mubang also reduced Patient C.C.’s methadone. For five months, he prescribed 180 10 mg tablets of methadone to Patient C.C., but he reduced that number first to 60 tablets, then to 30, then discontinued the prescription. Further, in a matter of three visits, the doctor went from prescribing Patient C.C. 470 pain pills per month to 180 tablets. For ten months, Dr. Mubang prescribed Patient W.B. 270 tablets of oxycodone. Then on November 6, 2010, Patient W.B.’s first visit after the doctor received notice of the investigation, he reduced Patient W.B.’s prescription of oxycodone to 240 tablets, then to 210 on the next visit. For five months, Dr. Mubang prescribed Patient B.D. 240 tablets of oxycodone. Then on November 11, 2010, Patient B.D.’s first visit with the doctor after he had received notice of the investigation, he reduced Patient B.D.’s prescription of oxycodone to 180 tablets. The logical explanation for Dr. Mubang’s sudden reduction in amounts of pain medication prescribed is that the Petitioner’s notice of investigation triggered him to change his prescribing practice. The notice of investigation might have been his “eureka” moment or it might have served as a wake-up call to him concerning his prior over-prescribing practices. The evidence clearly and convincingly demonstrates that Dr. Mubang used little critical medical judgment when prescribing dangerous controlled substances to the patients in this matter. His diagnoses were based solely on patient report, and his primary tool for treating these patients was the prescription of controlled substances without first exhausting less harmful treatment modalities or combining lower doses of controlled substances with his patients seeking other treatment modalities.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order: finding that Respondent, John Nkolo Mubang, M.D., violated sections 458.331(1)(nn), 458.331(1)(q), 458.331(1)(t), 458.331(1)(m), and 458.331(1)(cc), Florida Statutes, as charged in Petitioner’s Administrative Complaints; and revoking Dr. Mubang’s Florida medical license. DONE AND ENTERED this 25th day of June, 2019, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of June, 2019. COPIES FURNISHED: Chad Wayne Dunn, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Dale R. Sisco, Esquire Sisco-Law 1110 North Florida Avenue Tampa, Florida 33602 (eServed) Zachary Bell, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Claudia Kemp, JD, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 (eServed) Louise Wilhite-St Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed)
