Findings Of Fact The Respondent, Glenn R. Johnston, is a medical doctor, holding license number ME0018091. His address is 201 North Lakemont Avenue, Winter Park, Florida 32759. The Respondent obtained his Bachelor of Science degree from the University of Florida in 1966, and his medical degree from Bowman Gray School of Medicine in 1970. He served his internship and a two-year general family practice residency at Jacksonville Naval Hospital while serving in the Navy, and became board certified in family practice in 1973. Subsequently, the Respondent served for four years as Chief of the Family Practice Department at the Naval Regional Medical Center in Orlando. In approximately 1976 the Respondent entered private practice in Orlando with a group of doctors, and began his own medical practice in 1977. The Respondent has been married for sixteen years, and has two children, ages 11 and 13. The Respondent performs his family practice in a responsible manner, utilizing the prescription of narcotics and narcotic pain medications at an overall very low rate. The Respondent has never before been the subject of an investigation by the Department of Professional Regulation, and this is the first proceeding against him and his medical license. Between the dates of approximately July 1, 1980, and June 30, 1981, the Respondent prescribed Dilaudid (4 mg.) hydromorphone hydrdchloride for his patient, Robert Hicks in the quantity of 4499. Between the dates of July 3, 1980, and July 3, 1981, the Respondent prescribed Dilaudid (4 mg.) hydromorphone hydrochloride for his patient, James Everett, in the quantity of 4320. Between the dates of approximately July 3, 1980, and June 10, 1981, the Respondent prescribed Dilaudid (4 mg.) hydromorphone hydrochloride for his patient, Harold Stacy, in the quantity of 2550. Between the dates of approximately October 2, 1980, and November 20, 1981, the Respondent prescribed Dilaudid (4 mg.) hydromorphone hydrochloride, Percodan, and Tylox to his patient, Billy Carr, in the quantities of 1620, 30 and 30, respectively. Dilaudid, Percodan, and Tylox are Schedule II controlled substances pursuant to Chapter 593, Florida Statutes. The Physicians Desk Reference (PDR) states the following relative to Dilaudid: Description: DILAUDID (hydromorphone hydrochloride) (WARNING: May be habit forming), a hydrogenated keton of morphine, is a narcotic analgesic . . . * * * DRUG ABUSE AND DEPENDENCE: DILAUDID is a Schedule II narcotic. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, DILAUDID should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when DILAUDID is used for a short time for the treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependency may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. * * * Oral: The usual oral dose is 2mg. every 4 to 6 hours as necessary. The dose must be individually adjusted according to severity of pain, patient response and patient size. More severe pain may require 4mg. or more every 4 to 6 hours. If the pain increases in severity, analgesia is not adequate or tolerance occurs, a gradual increase in dosage may be required. If pain is exceedingly severe, or if prompt response is desired, parenteral DILAUDID should be used initially in adequate amounts to control the pain. The Respondent prescribed Dilaudid to patient Robert Hicks for severe chronic pain associated with multiple medical problems, primarily related to his severe degenerative rheumatoid arthritis. Mr. Hicks, 49 years of age, had a long history of multiple joint pains, degeneration of his normal joints, chronic pain in his joints, swelling and abnormal laboratory tests. He had been diagnosed as having rheumatoid arthritis since 1976 by a neurosurgeon, confirmed by blood tests and x-rays. He was classified as 100 percent disabled in 1977 by the Veterans Administration because of the chronic joint pains of rheumatoid arthritis. He had been seen by numerous doctors and treated with various pain medications including Dilaudid, which was the only drug that allowed him to function. The pains, discomfort and disability that Mr. Hicks suffered were located in most of the joints of his body, especially in his lumbosacral spine, with involvement in the left hip, shoulder areas, both knees and elbows, with swelling and deformity in the hands. Practically every joint in his body was involved. Mr. Hicks frequently used a cane for walking, and occasionally used crutches. He had difficulty in standing from a sitting position and on occasion he used a wheelchair. The Respondent tried several different medications to treat his rheumatoid arthritis, in addition to physical therapy, and used various pain medications, but Dilaudid proved to be the best when used in conjunction with treatment medications that would allow Mr. Hicks sufficient relief to work and function in a reasonably normal life-style. The Respondent prescribed 4 mg. Dilaudid tablets to Mr. Hicks, to be taken in doses within the limits recommended by the Physician's Desk Reference (PDR) in that the overall quantity prescribed for him did not exceed the maximum limit recommended by the PDR. Mr. Hicks also had other medical problems appropriately treated by the Respondent, such as subdeltoid bursitis, lateral ankylosing spondylitis, spondylolisthesis, Reiter's Syndrome, cervical spondylosis and diabetes. The Respondent prescribed Dilaudid in quantities of two pills of 4 mgs. every four hours as needed for pain, to patient James Everett for chronic severe pain stemming primarily from the lower chest wall and left upper abdominal chest wall which followed a transthoracic hiatal hernia repair performed in 1965. Mr. Everett also had angina with a history of one or two myocardial infarctions in 1970; he was on medication for the angina. The hiatal hernia repair left a surgical scar across his entire left chest, extending from the midportion of the back all the way across his chest and ending right above the stomach, at the lower part of the anterior chest wall, with another scar extending from his epigastric region down the mid-rib and into the lower midline area. During the surgical repair, Mr. Everett suffered a collapsed lung and suffered a great deal of scar tissue visible in his chest x-rays in the area where most of the pain is reported. Most of his pain resulted from the surgical scar tissue rather than the angina, as confirmed by a cardiologist. Mr. Everett was a very debilitated, elderly person, older looking than his 60 years, obese, very pale, with a slow gait; he perspired quite a bit and appeared to be a patient with chronic medical problems. Mr. Everett had been taking Dilaudid on prescription from his previous physician when he became the Respondent's patient. The quantity of Dilaudid prescribed for Mr. Everett did not exceed the maximum recommended dosage. The Respondent tried other medications and therapies to relieve the patient's chronic severe pain, with limited success, and used other methods of treatment for the patient's problems, which included diabetes and high blood pressure. Mr. Everett had been classified 100 percent disabled by the Veterans Administration because of his chronic severe pain. The Respondent concluded that Dilaudid was the only pain medication that would give the patient sufficient relief from pain to enable him to continue his employment and to function in his daily life. The Respondent prescribed Dilaudid in quantities of 2 tablets of 4 mgs. every 4 hours as needed for pain, to patient Harold Stacy for chronic severe pain relating to acute possibly pinched, nerve, lumbosacral low back pain with radiation into the left leg and degenerative arthritis, possible spinal cord tumor, early hypertrophic osteoarthritis, and possible hernitated disc. At age 49, Mr. Stacy was semi-crippled, always requiring a cane while walking and always in a great deal of pain. The hypertrophic arthritis was confirmed by calcium deposits visible on x-ray films. Mr. Stacy was never able to function normally, and could not maintain employment without the pain relief the Dilaudid provided. The Respondent used other medications in an attempt to relieve the pain, but found that Dilaudid was the only medication which would allow Mr. Stacy to work and function in as reasonable a fashion as possible. The Respondent treated Mr. Stacy's physical and health problems with an appropriate variety of treatment methods and medications. The quantity of Dilaudid prescribed for Mr. Stacy did not exceed the PDR recommended dosage. The Respondent prescribed Dilaudid, in dosages of 1-2 tablets of 4 mgs. every 4 hours, to patient Billy Carr for relief of chronic severe low back pain, related to chronic lumbosacral spine strain, chronic prostatitis and spondylolisthesis. Mr. Carr, at age 49, walked with a severe limp, had pain in his perineal area, had difficulty in sitting, and had a deformity in one of his legs due to a pseudoarthritis resulting from a malunion of a fracture of his femur. The Respondent tried several different pain medications and treatment methods, but found that Dilaudid was the only medication which would relieve the pain to allow Mr. Carr to work and enjoy as reasonable a life-style as possible. The quantity of Dilaudid prescribed for Mr. Carr did not exceed the maximum PDR recommended dosage. The Respondent is a board certified family practitioner. The Petitioner's expert witness, Dr. Robert Johnson, is a general practitioner who is not board certified. The Respondent's expert witnesses, Drs. Charles Grant, James Louttit and Clarence Bailey, are board certified in family practice and testified as such. All four expert witnesses testified, and it is so found, that a medically justifiable purpose in treating a patient is determined by the treating physician, and means a treatment which enhances the well-being of a patient and enhances the quality of a patient's life, in a manner the physician feels qualified to render. Reasonable physicians differ in the manner of treating the same condition. Reasonable physicians differ in the manner of treating pain. A person's pain is not measurable. A person's pain threshold is not measurable. One method of determining the level of medication needed to relieve a person's pain is by titration, that is, adjusting the quantity and type of medication to the patient's symptoms. Dilaudid is approved by the Federal Drug Administration for the treatment of pain. The Physician Desk Reference (PDR) does not place a cap on the quantity of Dilaudid to be prescribed for a patient in chronic moderate to severe pain. The analgesic effect of Dilaudid shortens with continued use. Some patients require a greater amount of Dilaudid to relieve pain than other patients. It is a medically justifiable purpose to prescribe Dilaudid to a patient for the relief of moderate to severe pain. It is a medically justifiable purpose to continue to prescribe Dilaudid to a patient for chronic moderate to severe pain. It is ethical, and medically justifiable, for a physician to treat a patient who is already habituated or tolerant to Dilaudid, and who has chronic moderate to severe pain, for the purpose of relieving this pain, since the patient should be given relief from the pain. There is no evidence that any of the four patients treated by the Respondent were drug abusers. It was medically justifiable for the Respondent to prescribe Dilaudid to each of his four patients during the time periods alleged in the Administrative Complaint. The quantities of Dilaudid prescribed by the Respondent to each of the four patients during the time period alleged in the Administrative Complaint were neither excessive nor inappropriate. The evidence is not sufficient to support a finding of fact that the Respondent failed to practice medicine with that level of care, skill and treatment which is recognized by a reasonable and prudent physician as being acceptable, under the circumstances alleged in the Administrative Complaint. There is insufficient evidence to support a finding that the Respondent engaged in repeated malpractice in the treatment of the four subject patients. Dr. Robert B. Johnson, testifying on behalf of the Petitioner as an expert general practitioner, did not feel that it was medically justifiable for the Respondent to prescribe Dilaudid in the quantities alleged, to each of the four patients, and he testified that such quantities were excessive. However, Dr. Johnson neither saw nor examined the patients, and he was not able to tell from reviewing the patient records how much pain any of the four patients were experiencing. Dr. Johnson also testified that, in his opinion, it is a gross departure from acceptable medical practice to prescribe the quantities of Dilaudid in question to a patient with any history other than terminal cancer, and that it would even be a questionable practice for this purpose; that three months would be the maximum length of time Dilaudid should be prescribed to a patient; and that it is not proper for a physician to continue to treat a patient for chronic moderate to severe pain by prescription of Dilaudid in the quantities and over the time periods alleged in the complaint; yet Dr. Johnson could find no physical harm to any of the four patients resulting from the Respondent's treatment. On the basis of the records reviewed, Dr. Johnson could not testify that the Respondent prescribed the Dilaudid in question other than in the course of his medical practice. The opinions of Dr. Johnson, however, were contradicted by the expert opinions of the Respondent's medical witnesses, Drs. Hailey, Grant and Louttit, except for their agreement that the Respondent's patients suffered no physical harm from their treatment by the Respondent, and that the Respondent prescribed Dilaudid to the four subject patients in the course of his medical practice. Where the expert medical opinions are in conflict, the testimony of Dr. Johnson is rejected as less credible than the opinions of Drs. Bailey, Grant and Louttit.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medical Examiners enter a Final Order finding the Respondent, Glenn R. Johnston, M.D., not guilty of Counts I, IV, VII, X and XIII in the Administrative Complaint, and that the Board dismiss the Administrative Complaint with prejudice. THIS RECOMMENDED ORDER entered this 30th day of September, 1983. WILLIAM B. THOMAS, 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 30th day of September, 1983. COPIES FURNISHED: Spiro T. Kypreos, Esquire 130 North Monroe Street Tallahassee, Florida 32301 Paul Watson Lambert, Esquire 1114 East Park Avenue Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Department of Professional Regulation, Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION, Petitioner, vs. CASE NO. 83-356 GLENN R. JOHNSTON, M.D., License No. 12142 Respondent. /
The Issue The issues presented herein are whether or not Respondent's incense to practice medicine should be suspended, revoked or the licensee otherwise disciplined for alleged violation of Chapters 458 and 893, Florida Statutes, as set forth in the Administrative Complaint filed herein signed May 31, 1983.
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received, stipulations of the parties and the entire record compiled herein, I hereby make the following relevant factual findings. Respondent is a medical doctor and has been issued license number ME 0017825. Respondent's last known address is 2361 N.W. 24 Terrace, Miami, Florida 33172. (Stipulation of the parties) Respondent has been licensed as a medical doctor in Florida since 1971. Respondent studied at Havana University School of Medicine and graduated in 1957. He practiced in Cuba from 1957 through 1966. During that period, he was engaged in a general practice and was also a psychiatrist at Clinica Dependiente. While at Clinica Dependiente, Respondent served as a medical director for the rehabilitation of minors and as medical director for Santa Clinica Psiquiatria. Respondent relocated from Cuba and came to Miami on or about February 15, 1967. Respondent sat for the Federation of State and Medical Boards of the United States during September of 1968, the standardized test for graduates of foreign medical schools. During 1968 and 1969, Respondent was engaged as a psychiatrist at Halifax District Hospital in Daytona Beach, Florida. During 1969, he served a rotating internship at Mount Sinai Hospital for one year. Thereafter, he served rotating internships at Doctors, Victoria, Parkway and one other hospital in the Dade County area until approximately 1974. During his tenure at Halifax Hospital, Respondent treated some parties who were drug addicts. Respondent admits to having treated the patients referred to in the Administrative Complaint filed herein. Additionally, pursuant to Petitioner's Request for Admissions filed herein, Respondent has admitted the allegations set forth in paragraphs 3, 10, 17, 24, 31, 38, 45, 52 and 59 of the Administrative Complaint, to wit: Between the dates of approximately January 5, 1981 and December 15, 1981, Respondent prescribed 360 Dilaudid 2/ (Hydromorphone), a controlled substance, pursuant to Chapter 893, Florida Statutes, for Patrick Golden. Between the dates of approximately March 26, 1981 and January 15, 1982, Respondent prescribed 1425 Dilaudid (Hydromorphone) for Ellen Henderson. Between the dates of approximately March 2, 1981 and November 11, 1982, Respondent prescribed 855 Dilaudid (Hydromorphone) for Ronald Chica. Between the dates of approximately May 12, 1981 and January 9, 1982, Respondent prescribed 132 Dilaudid (Hydromorphone) for James Brannigan. Between the dates of approximately February 19, 1981 and February 2, 1982, Respondent prescribed 965 Dilaudid (Hydromorphone) for Gilbert Fernandez. Between the dates of approximately November 21, 1981 and December 12, 1981, Respondent prescribed 180 Dilaudid (Hydromorphone) for Patsy Gamlin. Between the dates of approximately January 7, 1981 and January 14, 1982, Respondent prescribed 820 Dilaudid (Hydromorphone) for Rudolph Ferguson. Between the dates of approximately February 24, 1981 and February 15, 1982, Respondent prescribed 2220 Dilaudid (Hydromorphone) for Michael Salle. Between the dates of approximately February 24, 1981 and February 15, 1982, Respondent prescribed 2190 Dilaudid (Hydromorphone) for Ronald Weatherington. Dale K. Lindberg, M.D., was tendered and received as an expert in these proceedings in the area of Family Practice, Methadone and Drug Addiction. Dr. Lindberg has been instrumental in establishing a methadone detoxification program at Memorial Hospital in Hollywood, Florida. Methadone is the only legally recognized Schedule II controlled substance used in this country for the treatment of drug addiction. Private practitioners, pursuant to specific federal law, cannot legally administer methadone or any other Schedule II controlled substance for the treatment of drug addition. In order to qualify or be certified to treat drug addicts, application must be made simultaneously with the Federal Food and Drug Administration (to their Methadone Monitor Division), to the Federal Drug Enforcement Agency and to the Federal Department of Mental Health and Drug Abuse. Upon certification with these governmental departments, only then can a physician prescribe methadone to a drug addict to be ingested in oral form, once a day. (21 C.F.R. 291.505) Dr. Lindberg received and reviewed the nine (9) patients' records listed in the Administrative Complaint as well as the prescriptions written for those patients by Respondent. (Petitioner's Exhibit 2-19). Dr. Lindberg, after review, concluded that Respondent inappropriately and excessively prescribed Dilaudid to said patients. Dr. Lindberg opined that Respondent prescribed Dilaudid for those patients for "very little indication" and continued over long periods of time prescribing Dilaudid to those patients. He considered that Respondent was maintaining the patients on Dilaudid in violation of the law. (TR 148, 239). Dr. John Handwerker, M.D., testified as an expert herein on behalf of Petitioner. He has served as the first Chairman of the Department of Family Practice at the University of Florida Family and Community Medicine Programs. He is Chairman of the Family Practice Department of Mercy Hospital in Miami and is Assistant Professor of Pharmacology at the University of Miami. Dr. Handwerker is knowledgeable regarding generally prevailing and accepted standards of family practice in Dade County and was accepted, without challenge, as an expert in the field of Family Practice. Dr. Handwerker reviewed the nine (9) patients' records listed in the Administrative Complaint as well as the prescriptions written for each patient. Based upon Dr. Handwerker's review of those records and prescriptions, Respondent committed gross and repeated malpractice. This opinion stems from Respondent's "inappropriately and excessively prescribing Dilaudid to patient for chronic" while the Physicians Desk Reference clearly stated that Dilaudid should not be prescribed for patients with chronic pain. (Testimony of Dr. Handwerker) SPECIFIC PATIENTS A. Patrick Golden first visited Respondent's office on October 7, 1981. Golden complained of chronic pain arising from trauma suffered while he was involved in an industrial accident. His diagnosis was a compression of the fourth and fifth lumbar disk. He was treated for radiculitis. Respondent prescribed Dilaudid to relieve the pain that patient Golden was suffering from and based on the fact that Golden reportedly had been receiving Dilaudid from a former physician. Respondent conducted an examination of patient Golden and prescribed exercises for him. Respondent did not take x-rays although he states that he observed x-rays which had been taken by Golden's former physician. Respondent prescribed Dilaudid for Golden because it was the only drug which "killed the pain, unlike motrin and metrobromate." Nearing the end of Respondent's treatment of patient Golden, his wife began stealing Mr. Golden's drugs. Respondent referred her to a methadone program and obtained a notarized statement from Mrs. Golden to substantiate the fact that she was diverting drugs intended for her husband. Respondent observed that patient Golden was becoming addicted to Dilaudid nearing the end of his treatment although throughout the major portion of his treatment of patient Golden, he felt that while he was dependent on Dilaudid, he was not felt that while he was dependent on Dilaudid, he was not "addicted." Respondent tried to reduce the amount of Dilaudid that he was prescribing to patient Golden without success. Respondent believed that Dilaudid was medically necessary to treat patient Golden due to the suffering he was undergoing from the chronic pain. (Respondent's testimony and Petitioner's Exhibit 20). B. Ellen Henderson was treated by Respondent during the dates of approximately March, 1981 through January, 1982. Henderson suffered with her lumbar spine. Patient Henderson took motrin tablets since her preteen years. Patient Henderson has been treated at several methadone centers and is believed to have been taking approximately 25-40 Dilaudid four-milligram tablets per day. Upon Respondent's first treatment of patient Henderson, he advised her that she was "killing herself and that she needed to reduce that terrible dosage of Dilaudid." Patient Henderson was "treated for pain in the back and to reduce the amount of Dilaudid." In this regard, Respondent tried to reduce her intake of Dilaudid to approximately 8 Dilaudid four-milligram tablets per day. When Respondent stopped treating patient Henderson, he had reduced the amount of Dilaudid that he was prescribing for her to approximately 8 four- milligram tablets of Dilaudid per day. C. Respondent treated Ronald Chica from approximately March, 1981 through November, 1982. Chica was treated for spondylolysis--a degeneration of the vertebrae. Respondent prescribed Dilaudid for patient Chica because it relieved the pain. Respondent knew that patient Chica was addicted to the drug Dilaudid. D. James Brannigan was treated by Respondent from approximately May of 1981 through January of 1982. Respondent knew that Mr. Brannigan was dependent upon Dilaudid. Despite this knowledge, Respondent continued to prescribe Dilaudid for Mr. Brannigan in an effort to treat Brannigan's addiction with Dilaudid. Respondent was attempting to ease the withdrawal symptoms that patient Brannigan would suffer if he were immediately cut off from his supply of Dilaudid. E. Respondent treated patient Gilbert Fernandez during the dates of approximately February of 1981 through approximately February of 1982. During that period, Mr. Fernandez suffered from compression features of the ribs and the lumbar region. Mr. Fernandez had a physical and psychological dependence on the drug Dilaudid. Respondent treated patient Fernandez by prescribing Dilaudid tablets for him. Patient Fernandez had been treated at methadone centers in the past and presently was receiving methadone treatment while Respondent was treating him. Respondent prescribed Dilaudid to relieve the pain as well as to ease the withdrawal symptoms that patient Fernandez would undergo if he was immediately taken from the administration of Dilaudid. F. Between the dates of approximately February of 1981 through February of 1982, Respondent prescribed approximately 2,190 four-milligram Dilaudid tablets for patient Ronald Wetherington. Patient Wetherington was given approximately 60 tablets every 7 days. Patient Wetherington was addicted to the drug Dilaudid and Respondent ultimately referred him to a methadone center to deal with his withdrawal problems. G. During the period of February, 1981 through February, 1982, Respondent prescribed approximately 2,220 four-milligram Dilaudid tablets for patient Michael Sallee. Patient Sallee suffered from and was treated by Respondent for a compression fracture of the fifth lumbar. Mr. Sallee was a cabinetmaker and did considerable lifting in the performance of his work. Respondent knew that Mr. Sallee was dependent upon Dilaudid and continued to prescribe the narcotic during the term of his treatment. Respondent attempted to treat Mr. Sallee's addiction with Dilaudid. H. During the period of January of 1981 through January of 1982, Respondent treated patient Rudolph Ferguson and, during that period, prescribed approximately 820 four-milligram Dilaudid tablets for him. Patient Ferguson suffered from and was treated for back and rib problems from an auto accident. Respondent knew that patient Ferguson was dependent upon the drug Dilaudid and knew he was addicted to Dilaudid. Despite this knowledge, Respondent continued prescribing the drug Dilaudid to patient Ferguson to reduce the withdrawal symptoms and "to continue to treat the disease." Respondent referred patient Ferguson to a methadone clinic and, in fact, drove him to a nearby clinic for treatment. I. Respondent treated patient Patsy Gamlin during the period of November 21, 1981 through December 12, 1981. During that period, he prescribed 180 tablets or approximately 60 tablets every 10-14. Respondent administered a drug screen during December of 1981 and did not treat patient Gamlin after December. Dilaudid is a narcotic analgesic; its principal therapeutic effect is relief of pain. There is no intrinsic limit to the analgesic effect of Dilaudid; like morphine, adequate doses will relieve even the most severe pain. Clinically however, dosage limitations are imposed by the adverse effect, primarily respiratory, depression, nausea and vomiting which can result from high dosages. (Physicians Desk Reference, page 1038 [1984 Edition]) The Physicians Desk Reference has this to say about drug abuse and dependence: Dilaudid is a schedule II narcotic. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore dilaudid should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when dilaudid is used for a short time for treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, usually assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Prior to prescribing a drug such as Dilaudid, a physician should take a full history from a patient and perform a thorough physical examination. The history should include, inter alia, the patient's chief complaint, with questions from the physician to the patient involving areas of past problems with the nervous system, ears, eyes, lungs, chest, respiratory system, GI tract and urinary tract. The physical examination should involve all body systems, including blood pressure, examination of the head, neck, chest and back regions. If patient complains of low back pain, there should be a physical examination specifically involving the low back area before prescribing the scheduled controlled substance here at issue. The past history is important to determine the duration of the problem, any previous medical treatment, examinations or tests by other physicians regarding the lumbosacral or low back area. A physical examination should be performed designed to elicit indications of neurological evolvement, including straight-leg raise tests, impairment of sensation in the extremities tests and other neurological inquiries. Such a full history and a physical examination is prior to initiating a course of treatment involving treatment of chronic pain due to the existence of a wide assortment of other treatment modalities which might treat the root of the problem, rather than merely being pain symptoms. An examination of the Respondent's records and the prescribing patterns of Dilaudid for the patients involved indicates that Respondent simply made insufficient findings upon which to base the decision to prescribe the drug Dilaudid. By prescribing Dilaudid, without an adequate physical examination, or the gathering of detailed patient medical history, would constitute a failure to conform to the level of care, skill and treatment recognized by reasonably prudent similar physicians under these conditions and circumstances. By continuing to prescribe these drugs, without any involved discussion or consideration of the effect the previous course of treatment had had on the patient, other than simple inquiry by Respondent concerning, as example, how the patient was feeling, 3/ also constitutes inappropriate prescribing of scheduled controlled substances, and demonstrates a failure to conform to the generally accepted an prevailing standards of medical practice in the Dade County community. (Testimony of Dr. Handwerker) Respondent has never been subjected to disciplinary proceedings in the past. His past professional record reveals that he has a sincere concern for his patients. Throughout these investigative proceedings and the final hearing herein, the Respondent was candid, forthright and truthful. His prescribing of the controlled substance Dilaudid was based on his mistaken opinion that it was medically necessary to prescribe Dilaudid for his patients. Throughout these proceedings, it became clear that Respondent had not kept abreast of the proper course of treatment, detection and proper prescribing patterns for scheduled drugs for the patients be treated. To Respondent's credit, he has been studying the proper prescribing of controlled substances since the initiation of the investigation and the administrative proceedings involved herein. Respondent has never "faked" exams and every prescription that he wrote was based on an office visit and an exam, though a very cursory exam. Respondent did not receive any illegal profits from the sale of drugs nor did he divert, or attempt to divert, any drugs for illegal profit. His office fees, which range from $15 to $25 were not based on the amount of the drugs prescribed but, rather, on the patient's ability to pay. Respondent operates a small general practice with his wife serving as his receptionist. He personally completes all prescription forms with his wife/receptionist. Patients receiving treatment from Respondent are free to get their prescriptions filled at any pharmacy of their choice. Respondent was unaware and the evidence does not show that any of his patients had prior criminal records.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, and the entire evidence of record, it is therefore recommended that a Final Order be entered imposing a written reprimand and one year's probation upon the Respondent Carlos de la Fe, and requiring that during the probationary, he enroll and complete, to the satisfaction of the Board of Medical Examiners, a continuing medical education course concerned with the appropriate indications for and prescription of scheduled controlled substances. 4/ RECOMMENDED this 24th day of October, 1984 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 25th day of October, 1984.
The Issue Whether petitioner should take disciplinary action against respondent for the reasons alleged in the administrative complaint?
Findings Of Fact At all pertinent times, respondent Manuel P. Villaflor, M.D., held a Florida license as a physician, No. ME 0020072. He practices in Daytona Beach, where he has an office on Ridgewood Avenue. UNTIMELY DEATH K.D., a white male, was pronounced dead at 3:59 P.M. on October 19, 1985, a few days shy of his 34th birthday. The autopsy disclosed superficial abrasions, acute blunt trauma to K.D.'s face, scalp and right hand, and acute, diffuse subdural hemorrhage. A paper bag full of prescriptidn medicine containers accompanied the body to the autopsy. Apparently because the labels indicated that Dr. Villaflor had written pain killing prescriptions for K.D., the medical examiner's office notified DPR. Some four months later, analysis of samples of K.D.'s blood and urine revealed that codeine, oxycodone, amitriptyline, also known as Elavil, nortriptyline, also known as Pamelor, and chlordiazepoxide, also known as Librium, had been present in the corpse in quantities "beyond the reference range for therapeutic use." Botting deposition, p. 6. The pathologist amended his initial conclusion that head injuries resulting from "multi-focal blunt trauma," id., p. 7, had caused R.D.'s death, by adding "multiple drug intoxication," id., as another cause of death. As far as the record shows, Dr. Villaflor never prescribed Elavil, Pamelor, Librium or their chemical equivalents for K.D. An osteopath whom K.D. saw toward the end of his life prescribed at least two of these medications, as well as medicine containing oxycodone. CONTROLLED SUBSTANCES UNCONTROLLED On November 15, 1985, Diane Rabideau, an investigator for DPR, called on Dr. Villaflor at his office. He was polite and cooperative. Ms. Rabideau had some difficulty understanding him; he is not a native English speaker, and he had recently suffered a stroke. But she understood well enough Dr. Villaflor's assertions that he did not believe K.D. to have been addicted to any drugs, and that he had not over-prescribed any medicine. Ms. Rabideau inspected the controlled substances kept in Dr. Villaflor's office. She found Tenuate Dospan, Restoril, Darvocet, Valium, Tylenol No. 4, Fiorinal No. 3, Xanax, Vicodin, Tylenol with codeine elixir, Dalmane, Anexsia, Centrax, "Tussend Ex. 1/2 oz.," Limbitrol, Equagesic, Phrenilin with codeine, Novahistine, Naldecon, Ativan, Nucofed, and "P.V. Tussin." When she saw them, they were not under lock and key. No inventory records reflected what was on hand and what had been dispensed. The parties stipulated that Dr. Villaflor "failed to maintain records of the[se] schedule controlled substances . . . as required by Section 893.07, Florida Statutes"; and that he "failed to keep the[se] drugs . . . under lock and key as required by 21 C.F.R. Section 1301.72." When Ms. Rabideau pointed out these omissions, Dr. Villaflor and his wife, who works with him in the office, said they would comply in the future. Mrs. Villaflor said she had not known of these requirements. A subsequent inspection by a DPR investigation found Dr. Villaflor in full compliance with reporting requirements governing controlled substances. K.D.'s PAIN On July 8, 1981, Dr. Villaflor saw K.D., apparently for the first time, at the Halifax Hospital Medical Center emergency room, and admitted him to the hospital. K.D. had sustained an electrical shock when he struck a high voltage power line with an aluminum ladder, as he was hurrying for shelter from a sudden rain. He lost consciousness "surrounded by a bluish flame." Petitioner's Exhibit No. 12. The elecricity burned his feet and made his lower legs tender, as well. Discharged from the hospital, he visited Dr. Villaflor's office on July 15, 1981. In these proceedings, DPR does not question Dr. Villaflor's prescription of Percocet, a combination of Tylenol and oxycodone, for pain on that visit. As a teenager, K.D. had broken his collar bone in falls from motorcycles on two separate occasions. One accident involved a ride over a waterfall. When he was 2l years old, he "was smashed between a construction vehicle and a bulldozer," Petitioner's Exhibit No. 12, suffering "a severe crushing injury to his chest." Some ten years later he "still ha[d] very mobile ribs secondary to this injury," and persistent pain in his back and legs. In November of 1981, Dr. Kolin, a psychiatrist in Orlando, admitted K.D. to Orlando Regional Medical Center. A myelogram "revealed a mild L5 radicular lesion on the left, consistent with chronic myofascial pain and left L5 radiculitis." Petitioner's Exhibit No. 11. During this hospital stay, K.D.'s "narcotic medications were tapered and discontinued." Id. Dr. Villaflor sent copies of his records to Dr. Kolin, to whom Dr. Gillespie in Nashua, New Hampshire, had referred K.D. Apparently Dr. Villaflor never asked and Dr. Kolin never volunteered to forward Dr. Kolin's records to Dr. Villaflor. Gary G. Parsons, a vocation rehabilitation counselor, met K.D. on February 8, 1982. After K.D. made a perfect score on an aptitude test, a state agency subsidized his vocational training at the American Computer Institute. When K.D.'s training there concluded on January 4, 1983, Mr. Parsons tried to assist him in obtaining employment, but eventually concluded that K.D. could not hold a job because "his pain, and his limitation was greater than" (T. 283) Mr. Parsons had originally realized. K.D.'s pain or his physical condition "was primary in his conversation almost every time" (T. 283-4) he and Mr. Parsons spoke. Even after the vocational rehabilitation file was closed on June 26, 1984, he came by Mr. Parsons' office twice. Both times K.D. seemed depressed to Mr. Parsons, who had recommended he go for counseling to the Human Resources Center, a community mental health center. Mr. Parsons saw K.D. for the last time on March 22, 1985. At least as early as August of 1984, K.D. mentioned suicide to Mr. Parsons as a possibility. In March of 1985, K.D. began weekly counselling sessions with Dr. Rafael Parlade, a clinical psychologist at the Human Resources Center. In these sessions "the two issues . . . were his suicidal ideation combination with the depression, and the departure of his live-in girlfriend." (T. 273) He "still had a lot of pain." (T. 274) Dr. Parlade hoped K.D. would "increase his activities," (T. 276) so that with . . . activity in his life more, he would focus away from his pain. Because for a period of time that was all he was living with. (T. 276) Dr. Parlade viewed decreasing the amount of pain medication as a secondary goal (T. 275), a result he hoped would flow from K.D.'s being less preoccupied with the pain he experienced continually. PAIN REMEDIES On January 31, 1983, K.D. visited Dr. Villaflor's office. Dr. Villaflor's notes for that day mentioned K.D.'s "Electrocution High Voltage in 7/81" and reflect a prescription for 50 tablets of Talwin. K.D.'s blood pressure, 120 over 70, is noted, and reference is made to a TENS unit, or transcutaneous nerve stimulator. Somebody at the Orlando Pain Clinic K.D. had visited had recommended one of these electrical devices to K.D., but it had proved ineffective against his pain. At one time or other, K.D. resorted to acupuncture and resumed wearing a corset of the kind originally prescribed for the back pain he experienced in the wake of the cascading motorcycle accident. Dr. Villaflor's office notes of April 15, 1983, record "Back Pain," a second prescription for 50 tablets of Talwin and another prescription for Xanax. On May 11, 1983, Dr. Villaflor's records again note K.D.'s "Back Pain" and indicate prescriptions for Xanax and Percocet. Nothing suggests Dr. Villaflor knew that Talwin had been dispensed to K.D. five days earlier, when K.D. appeared at his office on May 26, 1983. Essentially illegible, Dr. Villaflor's office notes for May 26, 1983, reflect prescriptions for Percocet and Xanax tablets, with which K.D. obtained 30 quarter milligram Xanax tablets on June 6, 1983, and 35 Percocet tablets on June 8, 1983. Xanax, a tranquilizer, is taken three or four times daily. Since Percocet may be taken every four to six hours, it was "very much within reason" (T. 239) for Dr. Villaflor to prescribe more on June 9, 1983. When this prescription was filled on June 22, 1983, K.D. received 45 tablets. On July 7, 1983, Dr. Villaflor saw K.D. at his office for the first time in almost a month, and prescribed 35 more tablets of Percocet, also known as oxycodone with acetaminophen. The same day K.D. had the prescription filled, obtaining 35 tablets. Some three weeks later, on July 29, 1983, Dr. Villaflor again prescribed and K.D. again obtained 35 Percocet tablets. On the same day two other prescriptions Dr. Villaflor wrote for K.D. were filled, one for Atarax, an antihistamine sometimes prescribed in lieu of a tranquilizer, and one for Tylenol with codeine. This 35-tablet Tylenol prescription was refilled on September 7, 1983. With more and less potent pain medications, K.D. could take one or the other, as appropriate, depending upon the intensity of the pain. Since no other prescription for pain killing medication was written or filled until October 4, 1983, these prescriptions were, according to one of the Department's witnesses, "[w]ithin reason." (T. 243) On the October 4 visit, Dr. Villaflor noted "Back Pain from Electrocution" and recorded K.D.'s blood pressure as 138 over 70 or 80, before prescribing 45 Percocet tablets. That day, K.D. obtained the Percocet. He returned to Dr. Villaflor's office on October 13, 1983, complaining not only of back pain, but also of nausea and vomiting. Dr. Villaflor prescribed an additional 30 Percocet tablets. On October 15, 1983, K.D. acquired 50 tablets of the antihistamine Dr. Villaflor had been prescribing for him, "hydroxizine pam." On November 3, 1983, he obtained 60 Percocet tablets and 50 Tylenol No. 3 tablets. On November 12, 1983, the antihistamine prescripton was refilled as was, on November 16, the Tylenol No. 3 prescription. Perhaps Dr. Villaflor wrote the antihistamine prescription two days before it was first filled. The office notes are difficult to decipher. He wrote the Percocet and Tylenol prescriptions when he saw K.D. on November 3, 1983, at which time he recorded his blood pressure (132 over 70) and noted "back injury." On December 2, 1983, Dr. Villaflor's office notes reflect a visit and prescriptions for Tylenol No. 3, Percocet and the antihistamine. With respect to prescriptions filled on and after November 3, 1983, but before December 2, 1983, DPR's witness testified that the amount of medication was "a little high, but it's still, you know, again, acceptable for a person in pain." (T. 246) On December 2, 1983, K.D. obtained 60 Percocet tablets and 50 Tylenol No. 3 tablets, the latter by virtue of a prescription that was refilled on December 14, 1983. On January 3, 1984, K.D. returned to Dr. Villaflor's office where he obtained prescriptions for Percocet and Tylenol No. 3. In March, Dr. Villaflor began prescribing a tranquilizer, Dalmane, instead of the antihistamine, but the new year progressed much as the old year had, in terms of Dr. Villaflor's prescriptions and documentation, and, apparently, of K.D.'s pain, as well, until early August. On August 3, 1984, Dr. Villaflor prescribed for K.D., 200 "Sk- Oxycodone w/Apap" tablets, 200 Tylenol No. 4 tablets and 180 Dalmane capsules. K.D. had asked for them to take along to New England, where he travelled for an extended visit with his parents and others. This represented more than a two months' supply, and the prescriptions inspired a pharmacist, Paul Douglas, to telephone Dr. Villaflor's office before filling them. Mr. Douglas had called once before in the spring of the year, when he noticed that a total of 100 Tylenol (acetaminophen with codeine) No. 3 tablets and 60 tablets of Percocet (or the generic equivalent) had been dispensed to K.D. for use over a 24-day (April 2 to April 26, 1984) period. The pharmacist was concerned on that occasion because K.D. would have needed only 144, not 160, tablets during that period, if he had been taking no more than one every four hours. Back in Daytona Beach, K.D. presented himself at Dr. Villaflor's office on November 5, 1984, and received prescriptions for 45 tablets of Percocet, 55 tablets of Tylenol No. 3 and a quantity of Dalmane. All three prescriptions were filled the same day, and the prescription for Tylenol No. 3 was refilled on November 19, 1984. After his last telephone call to Dr. Villaflor's office, the pharmacist talked to K.D., telling him he would "not fill these medications again . . . until the prescribed number of days." (T. 222). On December 5, 1984, K.D. appeared a second time after his return from up north, and Dr. Villaflor again prescribed all three drugs, this time specifying 50 tablets of Percocet and 50 tablets of Tylenol No. 3. K.D. caused these prescriptions to be filled the day he got them. The office notes for both these visits mention only electrical shock by way of explanation for the prescriptions. On December 19, 1984, Dr. Villaflor suffered a stroke and was hospitalized. Two days later prescriptions he had purportedly written for K.D. were filled, but their authenticity, like that of the prescriptions filled on November 21, 1984, is not certain. While Dr. Villaflor was indisposed on account of the stroke, Dr. Wagid F. Guirgis filled in for him. The day he began, K.D. came in complaining of severe pain in his lower back and legs. Dr. Guirgis prescribed Dalmane, 50 Percocet tablets and 50 Tylenol No. 3 tablets, the latter prescription being twice refillable. Dr. Guirgis suggested to R.D. that he see an orthopedist or a neurologist, and, on January 21, 1985, refused K.D.'s request to prescribe more Percocet. At no time did Dr. Guirgis and Dr. Villaflor discuss K.D. or his treatment. Later the same day K.D. went to Dr. M.H. Ledbetter's office. This osteopath prescribed 30 Percocet tablets to be taken twice daily, as well as Elavil and Tranxene. On February 4, 1985, Dr. Ledbetter prescribed the same medicines. On February 28, 1985, Dr. Ledbetter prescribed Elavil, Librium and 50 tablets of Percocet. On March 22, 1985, he prescribed the same things. On April 19, 1985, K.D. again visited Dr. Ledbetter. The same day he purchased Librium and 60 Percocet tablets at Walgreen's. Dr. Ledbetter prescribed Librium, Elavil and 60 tablets of Percocet, to be taken twice daily, when he saw K.D. on May 16, 1985. In May Dr. Villaflor returned to his office, and K.D. appeared on May 21, 1985, five days after he had seen Dr. Ledbetter. Dr. Villaflor prescribed 60 Percocet and 50 Tylenol No. 3 tablets for K.D., along with Dalmane and a vitamin (Bl2) injection. K.D. weighed 142 pounds that day and his blood pressure was also noted. The office notes report "same complaints." On June 18, 1985, Dr. Villaflor prescribed 60 Percocet tablets, ten fewer than he prescribed on K.D.'s next visit, on July 17, 1985 , when K.D. limped "on left foot." In July, Dr. Villaflor also prescribed Dalmane and 50 Tylenol No. 3 tablets. On both visits K.D.'s weight (142 then 138) and blood pressure (122 then 120 over 80) were noted. On August 19, 1985, K.D.'s weight had fallen to 132 pounds but his blood pressure remained 120 over 80. Sixty Percocet tablets - one every four hours - were prescribed, as were 50 Tylenol No. 3 tablets. The diagnosis indicated in Dr. Villaflor's office notes was "electrocution." On September 16, 1985, Dr. Villaflor again prescribed Dalmane, Tylenol and 60 Percocet tablets. On October 17, 1985, K.D. limped to his last visit to Dr. Villaflor's office. His face bruised, K.D. complained that both feet were swollen, and reported that he had lost his balance and fallen down four stairs and over a concrete wall. For the last time, Dr. Villaflor prescribed Tylenol No. 3 and Percocet for K.D., 30 and 60 tablets respectively. Unbeknownst to Dr. Villaflor, K.D. had continued to visit Dr. Ledbetter, himself unaware of Dr. Villaflor's renewed involvement with K.D. On June 7, July 5, July 26, August 27, September 16 and October 10, 1985, Dr. Ledbetter prescribed Librium, Elavil and Percocet. Dr. Ledbetter's office notes also reflect K.D.'s fall. REQUIRED PRACTICE Keeping complete medical records is important not only as a mnemonic aid for the treating physician, but also to make the patient's history available to other physicians who may succeed or assist the recordkeeper. Although each is "a moderate type of analgesic," (T. 324), both codeine and oxycodone are "narcotic derivatives . . . [and] addictive in nature." Id. Dalmane "can be" (T. 221) "potentially addictive." Id. Because of his depression, K.D. "was not a good candidate" to entrust with several hundred pills at once. A physician who suspects addiction should limit prescriptions to "around ten to fifteen" (T.326) tablets and "start checking with other pharmacies to make sure if a patient is getting drugs from any other source . . . ." Id. He should perform "very close and repeated physical exams" (T. 327) and be alert for "overdose side effects," id., such as dizziness, slurred speech, or staggering. The evidence here fell short of a clear and convincing showing that Dr. Villaflor was remiss in failing to suspect addiction, however, Dr. Ledbetter, who had similar, albeit similarly incomplete, information apparently did not suspect. The evidence did not prove the existence of side effects from the drugs Dr. Villaflor prescribed. Although, on his last visit to Dr. Villaflor's office, K.D. reported dizziness, the cause is unknown. On the other hand, his office records do not suggest that Dr. Villaflor took any steps to determine the cause of K.D.'s dizziness or of his swollen feet. Dr. Villaflor's treatment of K.D. fell below acceptable levels, if he failed to refer K.D. for periodic reevaluations of the underlying orthopedic or neurological problem, which his records suggest he did not do. His treatment was also inadequate for failure periodically to "get the medicine . . . out of the system . . . for a limited time" (T. 337) in an effort to learn what side effects, if any, the drugs he prescribed caused, either singly or in combination. This is so, even though the effort might have been frustrated, if K.D. had acquired the same medicines from other sources.
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 Rainbow (herein sometimes Respondent) began operations as a methadone treatment center (outpatient methadone program) on May 15, 1988, with a probationary license for 90 days granted by the Petitioner, Department of Health and Rehabilitative Services. All methadone treatment programs begin operations with a probationary license. Methadone is a classified Schedule II narcotic drug, a synthetic opiate, manufactured in a pharmaceutical laboratory. It is highly addictive and for that reason, it is closely monitored and controlled by the Federal Drug Enforcement Administration, can only be dispensed and administered by authorized medical personnel and the authorized dispensers of methadone are required to maintain strict security of access to methadone. Respondent's operation is a drug abuse treatment and prevention program (DATAP) and is defined as such and governed by Chapter 397, Florida Statutes. Respondent's program is designed to assist its clients, particularly the heroin addict or someone who is taking the synthetic opiate Dilaudid, a popular street drug, to take the client "off the street," and give them a stabilizing dose of methadone so that they can return to a more fully functional and responsible life style. That is accomplished by first stabilizing the client on a dose of methadone which is acceptable to them physically and provide treatment planning and auxillary services to assist them in restructuring their life style. The goal of the program is to reduce the methadone a client receives with the ultimate idea of making the addict drug free. On July 13-14, 1988, Petitioner dispatched a technical team to inspect Respondent's program. The inspection team consisted of Phil Highman, Sr., Human Services Program Specialist, Anton Krone, M. D., Mark Engelhardt, Program Supervisor - HRS District VI, and Gail Potter, Senior Human Services Program Analyst. Respondent's President, Angela Duncan, was present along with Lois Knoffler, R. N., Nursing Supervisor and Barbara Reszac, L. P. N. Following the inspection, an exit conference was held on July 14, at which time the inspection team advised Duncan of numerous clinical and medical standard deficiencies which were not being complied with. The inspection team found that Respondent's problems were due principally to a lack of knowledge regarding addiction and methadone treatment and a general laxness in implementing and documenting service provisions. On the clinical side there was no evidence to suggest that charts were being reviewed on a consistent, regular basis to ensure that specific treatment activities were in compliance with Chapter 10E-7, Florida Administrative Code, and on the medical side, the Medical Director exhibited little experience in the addiction field and the services provided were minimal at best. Also, the Medical Director was not spending adequate time at the clinic. The following programmatic elements were in noncompliance with regulations and required corrective action. In the clinical area these were: An absence of a psycho-social assessment including a clinical summary of each record within 10 days of admission to out-patient maintenance treatment as required by Section 10E-7.039 (a)(g), Florida Administrative Code. Respondent's failure to provide signed credentialed and dated, psycho-social assessments for each client as required by Section 10E-7.032(18)(g), Florida Administrative Code. An absence of individualized treatment plans developed for each patient within 30 days of admission to include measurable goals and objectives and the type and frequency of services required and properly signed, credentialed and dated. Sections 10E- 7.032(28)(b) and 10E-7.039(3)(j)2., Florida Administrative Code. An absence of recorded progress notes in the case records in accordance with the frequency of counseling. Sections 10E- 7.039(3)(j)1 and 3, Florida Administrative Code. A failure to place on phase one, all persons admitted, readmitted or transferred to maintenance treatment absent an authorized exception. Sections 10E-7.039(3)(d)6. and 10E-7.039(3)(e), Florida Administrative Code. Failure to document that clients who violated clinical rules such as illicit drug use and absenteeism had received disciplinary actions appropriate to the nature of the violation. Section 10E-7.039(3)(h), Florida Administrative Code and Sections 291.505 (d)(8)(v), (b) and (1), Code of Federal Regulations. In the medical area the following deficiencies were noted: A failure to document that the program physician conducted a physical exam prior to administration of the initial dose of methadone absent a documentable emergency. Section 10E-7.039(2)(f)2., Florida Administrative Code. A failure to document that all physical exams con formed to the medical services requirements prescribed under Sections 10E- 7.034(1)(a) and 10E-7.039(2)(F), Florida Administrative Code. A failure to provide results of a laboratory test which is required on each patient at the time of admission. Section 10E-7.039 (f)(1), Florida Administrative Code. Failure to document that the program physician thoroughly documented each patient's current addiction and history of addiction before administering the initial dose of methadone. Sections 10E-7.039(2)(f) 5.A. and 10E-7.039(3)(a)1.-3., Florida Administrative Code. Failure to document that each patient had signed the "consent to methadone treatment" form prior to being administered the initial methadone dose. Section 291.505(d)(1)(ii), Code of Federal Regulations. A failure to document that the program physician signed or countersigned, within 72 hours, all orders relative to medication and take-home privileges. Sections 10E- 7.039(2)(f)5.d-f, Florida Administrative Code. On August 15, 1988, Petitioner advised Respondent of the non- compliance of the above-referred clinical and medical standards and by that notification, extended Respondent's first probationary license 45 days through September 27, 1988 to allow Respondent an opportunity to correct the deficiencies; placed a moratorium on admissions of new clients beginning August 14, 1988, and advised of its serious concern with the deficiencies with Petitioner's then consideration of denying Respondent a regular license. Respondent was further advised that Petitioner would continue to monitor Respondent's activities during the probationary period. Petitioner's moratorium limited Respondent to 49 clients. On August 30, 1988, Petitioner again dispatched an inspection team to Respondent's facility to monitor compliance. Petitioner's attendees were the same attendees who made up the earlier inspection on July 13-14, 1988. Administrator Duncan was present along with clinical supervisor, Bob Brouck and Clifford Frost, counselor. On the day of inspection there were 49 clients in treatment in keeping with the moratorium and current staff/client ratio was within acceptable standards. In the clinical area, the team reviewed 14 clinical records and while there were psycho-social assessments available in all case records, in 11 of 14 cases assessments had not been completed within the required 10 days of admission. In the area of treatment plans, plans were available in 13 of 14 cases. In two cases, plans were not completed within the required 30 days of admission and in none of the cases reviewed, was the information provided delineating the type and frequency of services to be provided. In the area of progress notes, improvement was shown in terms of content but in 12 of 14 cases, notes were not recorded with the proper frequency according to client phase level. Also, in 5 of 14 cases, urine drug screens indicated that the clients in question were involved in illicit drug use and no reference to these incidents were made in the progress notes. In the medical area, a total of 7 medical charts were reviewed. In the area of physical exams, in only 2 of 7 cases were physicals completed prior to administering the initial dose of methadone. In the remaining cases, physicals were either unavailable, undated or not completed within the required time frame. Laboratory tests were available in 6 of 7 cases. However, in only one of the six cases was the test completed upon admission. In one case the lab was unable to draw blood from the client because of difficulty in locating a vein. In all cases reviewed, there was adequate documentation of the client's current addiction. In the phasing and take-out privileges area, it was difficult to determine each client's phase level from the clinical records; however, an examination of dosing records indicated that patients were participating on the proper phase level according to time and treatment. Respondent's program was out of compliance in the following clinical areas: Psycho-social assessments were not completed within 10 days of admission as required. Individualized treatment plans were not developed within 30 days of admission and no reference was made to the type and frequency of services to be provided. Progress notes were not recorded in case records with proper frequency according to phase level and, Illicit drug use had not been addressed relative to appropriate disciplinary action. In the medical area, the following deficiencies were noted: Physical exams had not been conducted prior to the administration of the initial dose of methadone. Physical exams did not conform to the medical service requirements prescribed under Sections 10E-7.034(1)(a) and 10E-7.039(2)(f)1 Florida Administrative Code. Laboratory tests had not been conducted at the time of admission. See Section 10E- 7.039(2)(f)1, Florida Administrative Code. At that time, Petitioner extended Respondent's second probationary period for a full 90 days, i.e. from August 14, to November 11, 1988, to allow Respondent time to correct the noted program deficiencies and items of non- compliance with rules and regulations which were cited by the inspection team. On September 29, 1988, Petitioner's agents Emenheiser and Moffett again inspected Respondent's program to determine compliance with the moratorium on new clients. At approximately 9:30 a.m. on September 29, Emenheiser and Moffett went to Rainbow, knocked on the door and were admitted by Respondent's counselor, Clifford Frost whom Emenheiser met at the previous inspection visit. Respondent's operating hours were 6 o'clock a.m. to 2 o'clock p.m., seven days a week. Rainbow was open for business to administer and dispense methadone. At the time of their arrival, there was a client in Respondent's waiting area talking with Frost. Inspectors Emenheiser and Moffett asked Frost for entry into the methadone dispensing area and inquired as to the whereabouts of Administrator Duncan and the dispensing nurse. Neither were at the clinic. Frost left the area and obtained the key to the dispensing area and unlocked the dispensing room. At the time, there were no medical personnel in the facility. Counselor Frost is not a medical person nor is he authorized to enter the dispensing room or to dispense methadone. The inspectors, after gaining entry to the dispensing area by Frost, found the dispensing room safe open with a telephone cord draped between the safe door and the body of the safe. In the open safe they found a full bottle of methadone and a box with 4 full bottles next to it. On the dispensing room counter, the inspectors found a bottle with about two inches of methadone in it and a pipette dispenser in its top and a take-out bottle with a small amount of methadone. Emenheiser and Moffett observed the medication record which contained signed entries initial led in advance. While in the dispensing room, Inspectors Emenheiser and Moffett observed another client come into the facility and Frost administered the take- out bottle of methadone to the client in the dispensing room. The take-out bottle was prepared in advance by Frost. In this regard, Frost stated that he did not do that sort of thing very often. Based on the inspectors observance of the access by an unauthorized person to obtain entry into the storage area where the liquid methadone was stored, the absence of medical personnel at Respondent's premises during the period of time when the facility was open for business to dispense and administer methadone, the dispensing and administration of methadone to a patient by an unauthorized employee, and the general lack of security in the area where the methadone was stored, Petitioner's agents called the Federal Drug Enforcement Administration (DEA) to report their findings and the events they had witnessed. After confirming that these were security violations, the inspectors left the facility immediately to consult with their superiors. The inspectors later provided affidavits detailing their findings and provided assistance in drafting the administrative complaint and the emergency final order. Respondent was ordered to cease and desist all operations of its DATAP program effective at 5 o'clock p.m. on October 10, 1988. Clifford Frost, Respondent's counselor, gave testimony and maintained, via deposition, that he allowed Petitioner's agents access to the storage area where methadone was kept based on prior conversations that he had with Emenheiser to the effect that if he (Frost) would help him close down Respondent's program, he (Emenheiser) would help Frost get another job. Frost maintains that he was being led by Emenheiser to shut down Respondent's facility and that he did so in an effort to go along with Emenheiser's wishes. Emenheiser denied having any motivation to shut down Respondent's program and as a long term career veteran with Petitioner's DATAP programs, the absence of any bias having been shown by Respondent, Emenheiser's testimony is credited. Frost's testimony is not credited to the extent that his testimony differs from the versions of events found herein and as testified to by employees Phillip Emenheiser, Harry Moffett and Gail Potter.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Petitioner enter a final order revoking Petitioner's probationary license to operate a methadone treatment center. DONE and ENTERED this 26th day of July, 1989, in Tallahassee, Leon County, Florida. JAMES E. BRADWELL 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 26th day of July, 1989. APPENDIX TO RECOMMENDED ORDER CASE NO. 88-5518 Rulings on Petitioner's Proposed Findings of Fact Paragraph 9, rejected as conclusionary. Paragraphs 10 and 11, adopted as modified, last sentence in paragraph 23, Recommended Order. Paragraph 12, adopted as modified, paragraphs 11 and 15, Recommended Order. Paragraph 13, adopted as modified, paragraph 23, Recommended Order. Paragraph 14, adopted as modified, paragraph 10, Recommended Order. Paragraphs 15, 16, 17 and 18, adopted as relevant, paragraphs 11-14 and 24, Recommended Order. The remainder rejected as irrelevant and/or unnecessary. Paragraph 19, adopted as modified, paragraph 14, Recommended Order. Paragraph 20, adopted as relevant, paragraphs 15-17, Recommended Order. Paragraph 21, rejected, irrelevant. Paragraph 22, adopted as modified, paragraphs 19 and 20, Recommended Order. Paragraph 28, rejected, irrelevant. Paragraph 29, adopted as modified, paragraph 23, lines 16-21, Recommended Order. Rulings on Respondent's Proposed Findings of Fact Paragraph 1, adopted, paragraph 1, stipulated facts and paragraphs 1 and 18, Recommended Order. Paragraph 2, adopted, paragraph 4, stipulated facts. Paragraph 3, adopted as modified, paragraph 19, Recommended Order. Paragraph 4, first sentence, adopted and second sentence rejected based on contrary findings in paragraph 20, Recommended Order. Paragraph 5, rejected based on contrary findings in paragraph 24, Recommended Order. Paragraph 6, rejected as unnecessary to resolve the issues posed. Paragraphs 8-12, rejected based on contrary credibility resolutions stated in paragraph 24, Recommended Order. Paragraph 13, adopted as modified, paragraph 23, Recommended Order. Paragraph 14, rejected based on contrary findings in paragraph 23 to the effect that Frost was unauthorized to dispense and administer methadone. Paragraph 15, rejected as argument. Paragraph 16, rejected as irrelevant based on the determination in paragraph 23 to the extent there was a general lack of security in the storage of methadone and that such lack of security was in violation of the security requirements of a scheduled, highly addictive drug. Paragraph 17, rejected as argument. Paragraph 18, rejected based on contrary findings in paragraph 23 and the general lack of security by Respondent at the treatment center. Paragraph 19, rejected as irrelevant. Paragraphs 21 through 23, rejected, irrelevant and not probative of the issues posed. COPIES FURNISHED: Jack Farley, Esquire Department of Health and Rehabilitative Services 400 W. Buffalo Avenue 5th Floor, Room 500 Tampa, Florida 3361 Amelia M. Park, Esquire and William M. Park, Esquire 8001 North Dale Mabry Highway Building 601, Suite B Tampa, Florida 33614 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Building One, Suite 407 Tallahassee, Florida 32399-0700 John Miller, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
Findings Of Fact The parties stipulated that Monroe C. Schiffman is a pharmacist licensed by the Florida Board of Pharmacy. They further stipulated that Sharon Drugs, d/b/a Mercy Professional Building pharmacy is located at 3661 south Miami Avenue, Miami, Florida and that Sharon Drugs owns and operates Mercy Professional Building Pharmacy. The parties also stipulated that Monroe C. Schiffman was a corporate officer and share holder in Sharon Drugs, Inc., a Florida corporation, from February 1, 1975 until the dates of the audits in question and that Monroe C. Schiffman was a corporate officer and stockholder in Monroe Pharmacy, Inc. from March, 1974, until the audits in question. An inspection and audit of Sharon Drugs, Inc. d/b/a Mercy Professional Building Pharmacy, was begun on April 23, 1976 and lasted for several days. The audited period was from March 17, 1975 until April 26, 1976, during which dates Monroe C. Schiffman was the registered pharmacist for the operation of Sharon Drugs, Inc. The procedures for the audits were to assume a zero stockage as of March 17, 1975 and to account for the drugs received after that date. The drugs audited were controlled drugs as defined by Chapter 893, Florida Statutes. These drugs were chosen for audit because complete records of their order, receipt and dispensing must be kept pursuant to Chapter 893, Florida Statutes. Exhibit 1, a summary of the audit of Sharon Drugs, Inc., was identified by the Board's agent, Vernon K. Bell, as the summary of the discrepancies in controlled drugs revealed by the audit which he conducted. The audit conducted by Vernon K. Bell revealed a shortage of controlled drugs for which no records had been kept of 296,481 total units or pills. The drugs audited were Desoxyn (methamphetamine hydrochloride), Tuinal (sodium amobarbital and sodium secobarbital), Biphetamine (d- and dl-Amphetamine), Dilaudid (hydromorphone), Nembutal (sodium pentobarbital), Seconal (sodium secobarbital), Quaalude (methaqualone), Eskatrol Spansule (dextroamphetamine sulfate and prochlorperazine) , and Dexedrine (dextroamphetamine sulfate). Monroe C. Schiffman, while the registered pharmacist at Mercy Professional Building Pharmacy, did not keep the record required to be kept by law.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the license and registration of Monroe Charles Schiffman be revoked. DONE and ENTERED this 5th day of January, 1977, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Michael Schwartz, Esquire Suite 201, Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 Gerald Kogan, Esquire Suite 500 Security Trust Building 700 Brickell Avenue Miami, Florida 33131 H. F. Bevis, Executive Secretary State Board of Pharmacy 252 East Sixth Avenue Box 3355 Tallahassee, Florida 32303
The Issue The issues are whether Respondent failed to maintain an accurate medication record relating to narcotic medications in violation of Section 400.419(1)(b), Florida Statutes, and Rule 58A-5.0185(3)(b), Florida Administrative Code; and if so, what penalty should be imposed.
Findings Of Fact Petitioner has authority to license assisted living facilities (ALFs) and the duty to enforce all statutes and rules governing such facilities. Respondent is a licensed ALF with a total capacity for 35 residents. Respondent's License No. AL5888 is effective March 20, 2002, through March 19, 2004. On January 31, 2002, Petitioner completed a biennial survey of Respondent's facility. During the survey, Petitioner's staff observed Respondent's staff administering medication to six residents who needed medication assistance. Resident No. 6 received a narcotic medication, in tablet form, that she was supposed to take by mouth three times daily, as needed, for pain. The medication is addictive and may be obtained only by prescription. The prescription bottle at issue here indicated that it was filled on January 21, 2002, with 100 tablets. There is no other evidence regarding the number of tablets in the bottle when it arrived at Respondent's facility. Respondent did not count the tablets in the bottle upon receiving it from the pharmacy. Resident 6's MOR showed that she received the narcotic tablet three times daily, everyday, with no missed doses during the time period at issue here. According to the MOR, Resident 6 received a total of 32 doses of the medication beginning January 21, 2002, at 7:00 a.m. through January 31, 2002, at 12:25 p.m. However, the bottle contained only 54 tablets as of January 31, 2002, at 12.25 p.m. Respondent's staff could not explain or account for the 14 missing narcotic tablets. Under cover of a letter dated February 12, 2002, Petitioner advised Respondent that the biennial survey had identified a Class II deficiency relative to Resident 6's medication administration. The letter requested Respondent to file a plan of correction within ten days. Resident 6's narcotic medication was refilled on February 19, 2002, with 100 tablets. As of March 8, 2002, Resident 6 had 51 pills remaining in the new prescription bottle. On March 8, 2002, Petitioner's staff conducted a follow-up visit to Respondent's facility. The count of tablets in Resident 6's narcotic medication prescription bottle, when compared to the MOR, was correct at that time. Under cover of a letter dated March 15, 2002, Petitioner advised Respondent that the previously cited deficiency had been corrected.
Recommendation Based on the foregoing Findings of Facts and Conclusions of Law, it is RECOMMENDED: That Petitioner enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 10th day of October, 2002, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 10th day of October, 2002. COPIES FURNISHED: Michael O. Mathis, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308-5403 Alvin L. Peters, Esquire 25 East Eighth Street Panama City, Florida 32401 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
