Findings Of Fact 1. Respondents Janet and Leonard Spivak acquired Hel- Len's Culinary Den II while they were still married, and their joint ownership persisted even after their divorce. Their marriage was dissolved some two or three years before the hearing. 2 During the month of October, 1979, Mr. Spivak was working as an accountant five days a week and helping out at the restaurant on weekends. On October 12, 1979, he was busy at the pizza oven 30 or 40 feet from Janet Spivak when he heard a disturbance and looked up to see Mrs. Spivak being arrested. She had just sold drugs, including 100 tablets of methaqualone, to an undercover deputy sheriff. Leonard Spivak had had no prior knowledge of his former wife's involvement with illicit drugs. At the time of Mrs. Spivak's arrest, Joseph Williams, the Broward County deputy sheriff to whom Mrs. Spivak sold the drugs, also arrested one Goldsmith, who had arranged the transaction at Williams' behest. Before his conversation with Goldsmith on October 12, 1979, Williams had no reason to suspect that drugs were being sold at Hel-Len's Culinary Den II. After her arrest, Mrs. Spivak produced all other pills and medications in her possession, upon instructions to do so. Among the pills were black capsules containing phentermine, a stimulant sometimes prescribed for weight loss, and blue diazapam tablets, which are sold under the trade name of Valium. Both of these drugs Mrs. Spivak kept for personal consumption.
Recommendation It is, accordingly, RECOMMENDED: That petitioner revoke respondents' license. DONE and ENTERED this 13th day of August, 1980, in Tallahassee, Florida. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: James Watson, Jr., Esquire Department of Business Regulation 725 South Bronough Street Tallahassee, Florida 32301 George Yochmowitz, Esquire Suite 906, Dupont Plaza Center Miami, Florida 33131 ================================================================= AGENCY FINAL ORDER =================================================================
The Issue Whether Respondent, Lawrie B. Glickman, D.D.S., violated Section 466.028(1)(q), Florida Statutes, by prescribing for himself, once, Promethazine/Phenyleph/Cod, and twice, Testosterone 200 mg/mcl 10 cc?
Findings Of Fact The Parties The Agency for Health Care Administration is in the Department of Business and Professional Regulation. Section 20.42, Florida Statutes. The Agency's Division of Health Quality Assurance contains the Board of Dentistry, Section 20.42(2)(a)2., Florida Statutes, which is responsible for "carry[ing] out the provisions of [Chapter 466, Florida Statutes,]" Section 466.004(1), Florida Statutes, the chapter through which the State of Florida regulates the practice of dentistry, dental hygiene, and dental laboratories. Lawrie B. Glickman, D.D.S., licensed by the State of Florida to practice dentistry under license number DN 0001383, has practiced dentistry in Tampa since 1957. Currently a sole practitioner, Dr. Glickman's practice includes all phases of general dentistry, among them, periodontal surgery, periodontal treatment, orthodontics, and orthopedic orthodontic treatment. Approximately ten percent of his practice is pediatric dentistry. Promethazine/Phenyleph/Codeine Phenergan VC or Promethazine VC with Codeine Cough Syrup ("promethazine cough syrup,") is an oral medication used by Dr. Glickman in his practice. Each 5 ml teaspoonful of promethazine cough syrup contains 6.25 mg of Promethazine Hydrochloride, 10 mg of codeine phosphate and 5 mg of phenylephrine hydrochloride. "Promethazine is a phenozathine derivative that is frequently used in dentistry, primarily in pediatric dentistry, as a sedative-hypnotic administered either orally or intramuscularly." Respondent's Ex. No. 2, Sedation, A Guide to Patient Management, Stanley F. Malamed, D.D.S., Professor and Chair, Section of Anesthesia and Medicine , University of Southern California, Mosby, 3rd Ed., p. 375. It also has antihistaminic action. Respondent's Ex. No. 2, Physician's Desk Reference, p. 2585. Phenylephrine, in therapeutic doses, "mainly causes vasoconstriction." Respondent's Ex. No. 2, Physician's Desk Reference, p. 2585. "Following oral administration . . ., constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. [N]asal decongestion may occur within 15 or 20 minutes and may persist for up to 4 hours." Id. Codeine is a controlled substance listed in Schedule II of the Florida Comprehensive Drug Abuse Prevention and Control Act. As such, it "has a currently accepted but severely restricted medical use," Section 893.03(2), Florida Statutes, because it has "a high potential for abuse . . . [which] may lead to severe psychological or physical dependence." Id. Dr. Glickman provides promethazine cough syrup to congested patients to whom he wants to administer nitrous oxide. Consistent with the Physician's Desk Reference's description of its clinical pharmocology, he finds that within "fifteen or twenty minutes after [the syrup's] usage congestion is reduced to the point of the airway being opened." (Tr. 55). Reduction of congestion in the congested patient expected to receive nitrous oxide is necessary because nitrous, a legend drug commonly used in the practice of dentistry as a mild sedative, is administered in the form of gas via inhalation. For nitrous to be optimally effective, the patient must be able to breathe freely; hence, the use of the syrup with its decongestant capability. The syrup has additional uses of value during dental procedures. It depresses coughing, nausea, and vomiting. Testosterone Cypionate Injection Dr. Glickman uses testosterone cypionate in a preliminary stage of oral tissue graft surgical procedures. Prior to the actual grafting of the tissue onto the oral cavity where needed, tissue taken from the palate of the patient is soaked in testosterone cypionate in order to promote epithelization (a growth process of covering the surface of the oral cavity with epithelium, cellular tissues that normally cover the lining of body cavities), and ultimately healing and bonding of the graft tissue inside the mouth. Testosterone cypionate comes in a liquid form in an injectable vial. As an anabolic steroid, testosterone cypionate falls into the category of "any drug or hormonal substance, chemically and pharmacologically related to testosterone, other than estrogens, progestins and corticosteroids, that promotes muscle growth . . .". Section 893.03(3)(d)1., Florida Statutes. Furthermore, it is a named anabolic steroid in the Schedule III list of controlled substances. As a Schedule III controlled substance, use of testosterone cypionate may lead to physical damage, but it has a potential for abuse less than the substances contained in Schedules I and II. Section 893.03(3), Florida Statutes, states that "it has a currently accepted medical use in treatment in the United States . . .", although the statute does not describe the use. Testosterone has been accepted for use in Europe in the healing of gangrenous tissues of diabetic patients or patients with cardiovascular disease. Although its use in dentistry is not widespread, as evidenced by Dr. Glickman's lack of awareness of any publication proclaiming its use in periodontics and Dr. Gumm's lack of awareness of its use in dentistry, testosterone has been commended by at least one authority in the field of dentistry as useful for the healing of oral wounds. Dr. Glickman first learned of its potential for promoting healing and epithelization in dentistry at a Boston University muco-gingival surgery course presented by Dr. Gerald Kramer, at that time, head of the university's periodontal department. Dr. Kramer recommended the use of testosterone in dentistry because of healing powers due to its anabolic effects. Dr. Glickman, moreover, has personal knowledge of testosterone's effects because it was prescribed for him by a urologist, Lawrence F. Grey, M.D. of the Grey Clinic in Urology following a surgical procedure. Liquid Injectable Testosterone Dr. Glickman obtained testosterone cypionate for his practice in an injectable, liquid form because it is not available in any other form. At hearing, Dr. Glickman described his handling of it in the following way: . . . [A]n injectable bottle has a metal ring with a rubber stopper. We would cut off the metal ring and then you could use it as any other bottle that would have a top. We would take off the rubber stopper, pour a little bit in this little tray we would use, and the graft material would be saturated in that. And again, as I stated a minute ago, it aids in wound healing, epithelization, and that's what you need when you do a tissue graft. (Tr. 56). Three Prescriptions Dr. Glickman wrote and signed a prescription dated October 21, 1993. The actual prescription was introduced into evidence. Handwritten on the prescription is "TESTOSTERONE CYPIONATE INJECTION 200mg.ml 10cc," in the name of "LAWRIE B. GLICKMAN," age "61," address, "8027 INTERBAY BLVD." Petitioner's Ex. No. 2. Dr. Glickman's office address is printed on the head of the prescription form as 4221 El Prado Boulevard in Tampa. According to DEA Drug Usage Report No. RX0415, dated August 4, 1994, a record kept by Walgreen's Pharmacy, another prescription was submitted to its "Store No. 01000" at "225 W.Shore Plaza" in Tampa, four months earlier. This second prescription submitted on June 20, 1993, was for "promethazine/phenlyeph/cod" in the patient name of "Lawrie Glickman," with a patient address of "4221 El Prado, Tampa, Florida, 33629," written by "L.B. Glickman," and a doctor's address of "4221 El Prado." Petitioner's Ex. No. 1. According to the same DEA Drug Usage Report, a third prescription was submitted to Walgreen "Store No. 01000" at "225 W.Shore Plaza" in Tampa on January 17, 1994, for "testosterone 200mg/ml" in the patient name of "Lawrie Glickman," with a patient address of "4221 El Prado, Tampa, Florida, 33629," written by "L.B. Glickman," and a doctor's address of "4221 El Prado." Id. Oddly, the same DEA Drug Usage Report also reflects that the first prescription referred to above, the October 21, 1993 prescription for testosterone, had a patient's address the same as Dr. Glickman's office address, 4221 El Prado, rather than the address reflected for the patient on the actual prescription: "8027 INTERBAY BLVD." In any event, Dr. Glickman wrote three prescriptions in the name of Lawrie B. Glickman or Lawrie Glickman. One was for "promethazine/phenyleph/cod" on June 20, 1993. The other two were for tesotosterone cypionate injection 200 mg/ml 10 cc, referred to in short on the Walgreen's records as "testosterone 200 mg/ml." The two testosterone prescriptions were submitted to Walgreen's on October 21, 1993 and January 17, 1994. Not for Personal Use The three prescriptions were not written for Dr. Glickman in the sense that they were for his own personal use in the way of the testosterone prescription Dr. Glickman's urologist, Dr. Grey, had written following Dr. Glickman's surgery. Rather, Dr. Glickman wrote the three prescriptions for general office use and solely for such use. In the case of the promethazine/phenyleph/cod, the use to which the substance was to be put was decongestion of patients in conjunction with the administration of nitrous oxide. This finding is borne out not only by Dr. Glickman's unrebutted testimony as to the purpose of the prescription but by a sticker dated "06/20/93," attached to Respondent's Ex. No. 1, a bottle of Promethazine VC with Codeine Cough Syrup given to Dr. Glickman in the name of "Lawrie Glickman," id., with the typed notation, "office use." Id. In the case of the testosterone, the office use was a solution in which tissue taken from the palate of a patient was soaked in anticipation of a tissue graft. Not only were the prescriptions written by Dr. Glickman for use in his dental office and office use alone, but there is no evidence that they were later put to any other use. Dr. Glickman did not, in fact, use them at any time for or on himself personally. Improper Means When Dr. Glickman wrote the three prescriptions for general office use in his own name as if he were the patient, he did not follow proper procedure. If a practitioner wishes to obtain controlled substances for use in an office, the practitioner should order the substances by invoice from a wholesaler licensed to provide the substances. There is never an occasion when a practitioner is allowed to obtain controlled substances for use in an office by means of a prescription in his own name or the name of his office. The prohibition is codified in 21 Code of Federal Regulations, part 1300, s. 1306.04(b), of which official recognition has been taken: A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purposes of general dispensing to patients.
Recommendation Accordingly, based on the foregoing findings of fact and conclusions of law, it is recommended that a final order be entered by the Board of Dentistry finding Lawrie B. Glickman, D.D.S., to have committed technical violations three times, on the dates charged in the Amended Administrative Complaint, of Section 428.066(1)(q), Florida Statutes, placing him on probation for three months during which time he should take and complete a continuing dental education course, if one is available, related to proper procedures for prescribing controlled substances, and fining him $250 per violation, for a total of $750. DONE AND ENTERED this 24th day of June, 1997, in Tallahassee, Leon County, Florida. DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 24th day of June, 1997. COPIES FURNISHED: Natalie Duguid, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32308-14229 Michael L. Kinney, Esquire Post Office Box 18055 Tampa, Florida 33679-8055 Jerome W. Hoffman, General Counsel Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive Tallahassee, Florida 32308-5403 William Buckhalt, Executive Director Board of Dentistry Division of Medical Quality Assurance Boards Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive Tallahassee, Florida 32308-5403
The Issue In addition to the issue of whether the Respondent committed the acts alleged, the administrative complaint alleges on its face that the Respondent was not licensed to practice medicine in the State of Florida until July 13, 1982. Most of the administrative complaint relates to alleged violations by the Respondent prior to the date of his licensure. A primary issue is the Petitioner's jurisdiction over the Respondent to prosecute for acts committed prior to his licensure. A major factual issue in this case are the dates upon which the doctor's conduct allegedly took place.
Findings Of Fact The Respondent was licensed as a medical doctor on July 13, 1982, in the State of Florida. Prior to that date the Respondent was not licensed to practice medicine in this or any other state. Prior to his licensure he was participating in a medical internship program in Pensacola, Florida. He was permitted to practice and prescribe medicine as an intern in and within the limits of this program. (Re: Count I through Count IV) The Respondent presented prescriptions for Eskatrol and Dexedrine on two different occasions to two different pharmacies. These prescriptions listed the Respondent as the person for whom the prescriptions were filled and signed by the Respondent. Neither prescription was accepted by the pharmacists and neither prescription was introduced into evidence. Eskatrol and Dexedrine are amphetamine compounds and are Schedule II controlled substances. The Respondent's ex-wife placed the Respondent's use of amphetamines in February of 1981. See Transcript page 95 line 19 through page 96 line 1. One of the pharmacists to whom the prescription was presented by the Respondent was Ann Cole Wilson, the Respondent's former sister-in-law and sister of his ex-wife. Wilson's testimony concerning the date of the alleged occurrence testifies as follows: Q. Can you tell me what occurred on that occasion, and tell me approximately when this occurred? A. Like I say, it's hard to remember. It was sometime during the summer months. Q. The summer of what year? A. Oh, gosh. Right now it's been, let's see, `82 or `83. Q. The summer of `82? A. I would say `82 yeah. The other pharmacist who testified regarding the Respondent's presentation of prescriptions for amphetamines was Elizabeth S. Grimsley. Grimsley testified regarding the alleged events as follows: Q. How did you come to meet him? A. He brought in a prescription one night for, two prescriptions, rather, written for him by himself for Eskatrol and Dexedrine, amphetamine prescriptions. Q. These prescriptions were written for the use of Dr. Taylor and they were written by Dr. Taylor? A. Yes, sir. Q. Do you remember approximately when this occurred? A. No, sir; roughly a year and a half or two years ago, I suppose. The latter witness is very vague about the date, and the former witness has an interest in these proceedings by virtue of her relationship with the Respondent's former wife. The relationship by Respondent and his former wife is characterized by hostility and continuing litigation arising out of their divorce and concerning child custody. It is concluded that the Petitioner failed to prove the acts occurred after the date of the Respondent's licensure. (Counts V, VI) The Respondent ordered legend and other drugs from pharmaceutical companies using the name of Michael Archer, M.D. and Archer's DEA registration number. Archer did not approve the order or give the Respondent permission to use his DEA registration in order to obtain these drugs. Respondent's actions took place in 1981 and 1982 prior to the date of the Respondent's licensure by the Florida Board. See the depositions of Farrell, Schied & Perez. (Count VII) Between the dates of March 3, 1982, and June 30, 1982, the Respondent submitted drug orders for and received thirty Crescormon No. 4 iu- vials from Pharmacia Corporated, 800 Centennial Avenue, Piscataway, New Jersey 08854. These events occurred prior to the Respondent's licensure by the Petitioner. See deposition of Schied, Exhibit 3. Respondent ordered amino acids from Varitex Corporation, a Michigan company. These materials which are not legend drugs were ordered and received by the Respondent prior to the date of his licensure by the Petitioner. See deposition of Myers, Exhibit 4. Respondent ordered various drugs from Generix Drug Corp., 1900 W. Commercial Blvd., Ft. Lauderdale, Florida, in the same manner. All these transactions occurred before the Respondent was licensed. See the deposition of Perez, Exhibit 5. (Count VIII) The Respondent sold or provided Darrell R. Black substances represented by the Respondent and thought to be by Black a drug with the trade name Dianabol. Dianabol is a steroid and a legend drug. This transaction was not a part of Dr. Taylor's practice under the Pensacola Education Program, the internship in which Dr. Taylor was participating. This transaction occurred in 1981, prior to Dr. Taylor's licensure by the Board. See Transcript page 38. The Respondent sold or provided to Shaun Francis Farrell drugs represented by the Respondent and thought to be by Farrell testosterone and Deca-Durabolin. This transaction was not part of the Respondent's internship in the Pensacola Educational Program. These transactions occurred in 1981, prior to Respondent's licensure by the Board. See Transcript page 46. (Count IX) The Respondent presented prescriptions for and received various metabolic steroids during 1981. However, all of these were presented prior to the date of the Respondent's licensure by the Board. See Transcript, pages 15, 16, 20, 21, 22, 31, 32, 33. One prescription for Trisorlan was presented by the Respondent for himself on October 20, 1982. Trisorlan is a legend drug, however it is not a controlled substance. Trisorlan is a drug affecting the pigmentation of skin. Transcript page 24. No evidence was received concerning the propriety of Dr. Taylor prescribing this medication for himself. (Count XI) No evidence was received that the Respondent held himself out as being licensed to practice medicine. Black and Ferrell did not see Respondent as a doctor. Respondent saw Cayton at the hospital and was authorized to treat patients within the scope of his internship. Most of the witnesses stated that they knew that the Respondent was a doctor, that he was "practicing" at Sacred Heart Hospital. The Respondent holds a degree as an M.D. and was practicing at Sacred Heart as an intern. Further to the extent that the Respondent may have held himself out as a physician contrary to Section 458.327, he did so prior to the date of his licensure and acquisition of jurisdiction by the Board.
Recommendation Having found no evidence to support the jurisdiction of the Board over the Respondent on the allegations of Count X, the Hearing Officer recommends that the Board take no action against the Respondent and the administrative complaint against the Respondent be dismissed. DONE and ORDERED this 4th day of February, 1985, in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 4th day of February, 1985. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Dorothy Faircloth, Executive Department of Professional Director Regulation Department of Professional 130 North Monroe Street Regulation Tallahassee, Florida 32301 Board of Medical Examiners 130 North Monroe Street William Taylor, M.D. Tallahassee, Florida 32301 5271 Myrtlewood Sarasota, Florida 33580 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Salvatore Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact Section 465.025(2), Florida Statutes, states that, when filling prescriptions for medication, Florida pharmacists must substitute less expensive generically equivalent drugs for the physician-prescribed medication, unless the physician or patient requests otherwise. A "generically equivalent drug product" is defined at section 465.025(1)(b), Florida Statutes, to mean the same active ingredient, finished dosage form, and strength. For a physician to indicate that the prescription should be filled as written, the statute provides at section 465.025(2), Florida Statutes, that the doctor must write the words "medically necessary" on the prescription, or in the case of an oral prescription, so indicate to the dispensing pharmacist. Section 465.025(6), Florida Statutes, provides for the establishment of a "negative drug formulary." The formulary is a list of drug products which are determined by the Boards of Pharmacy and Medicine "to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, would pose a threat to the health and safety of patients receiving prescription medication." Substitution by a pharmacist of a generic drug for a physician- prescribed brand name drug is prohibited in cases where the drug is included in the negative formulary. The Boards have established the formulary by Rule 215- 5.001 Florida Administrative Code. Neither the statute nor rule provide a definition of "clinically significant biological or therapeutic inequivalence." In the case of carbamazepine, it is clear that clinically significant biological or therapeutic inequivalence between brand Tegretol and the generic formulations would pose a serious threat to the health and safety of patients taking the medication. The rate at which active ingredients are dissolved and absorbed into the blood stream, and the time period during which such ingredients remain at therapeutic levels are critical in terms of properly titrating patient dosage levels. In the case of carbamazepine, the task is further complicated by the fact that carbamazepine affects its own elimination from the human body. On May 1, 1987, the Board of Pharmacy received a request from Ciba- Geigy, a pharmaceutical company, to add carbamazepine to the "negative drug formulary." Carbamazepine is the generic name for an anticonvulsant drug used in the treatment of epilepsy and other disorders. The effect of placing carbamazepine on the negative drug formulary would be to prohibit the substitution of generic carbamazepine for physician-prescribed "Tegretol," a Ciba-Geigy product. Carbamazepine was first marketed under thee brand name Tegretol, the so-called "innovator" form of the medication. Following the expiration of Ciba- Geigy's proprietary rights to the chemical formulation marketed as Tegretol, generic carbamazepine manufacturers began to produce the drug. Tegretol is still manufactured and marketed by Ciba-Geigy. In addition to Ciba-Geigy, there are six manufacturers of generic carbamazepine. Lemmon Company manufactures and markets "Epitol," one of the generic carbamazepine products. Tegretol and Epitol are conceded by the Respondent to be virtually identical. Lemmon Company manufactures and markets innovator and generic drugs distributed in Florida through sales to small independent pharmacies, wholesalers and chain pharmacies. Annual Epitol sales in Florida are estimated to be approximately $560,000. Ciba-Geigy, as justification for the request to add carbamazepine to tide negative formulary, asserts that the biological and therapeutic inequivalence between brand Tegretol and generic carbamazepine causes seizures or other side effects in patients who are switched from Tegretol to generic carbamazepine. However, the evidence does not establish clinically significant differences between Tegretol and generic carbamazepine which would support a finding of biological or therapeutic inequivalence. The evidence does not support a finding that alleged seizures or other side effects, where they have occurred, have resulted from the change in medication. The prohibition against the substitution, by a dispensing pharmacist, of a generic drug for a brand name drug is clearly beneficial to the branded drug's maker and detrimental to the manufacturers of the generic products. Because Tegretol, as the innovator, was the sole available formulation of carbamazepine for an extended period of time, prescribing physicians are more likely to be aware of, and to prescribe, the brand name Tegretol. Prohibition of generic substitutions undoubtedly impacts the sales of such generic drugs; thus Lemmon Company is substantially affected by the action of the Respondent in placing carbamazepine on the negative drug formulary. Following receipt of the Ciba-Geigy request, the Director of the Board of Pharmacy referred the issue to the Negative Formulary Study Committee for review. The study committee includes consultants to the board from the University of Florida Colleges of Pharmacy and Medicine. The review process apparently provides for initial consideration by the study committee which makes recommendations to the Negative Formulary Committee which, in turn, makes recommendations to the Boards of Pharmacy and Medicine. On July 1, 1987, the study committee considered the Ciba-Geigy request, including information submitted by Ciba-Geigy apparently consisting of limited anecdotal data, and thereafter elected not to recommend carbamazepine for inclusion on the negative drug formulary. The rationale for the determination was that the anecdotal information provided by Ciba-Geigy was not persuasive, and that there was no well-controlled clinical evidence demonstrating therapeutic differences between carbamazepine brands. On September 22 and November 25, 1987, the study committee met and again considered the Ciba-Geigy request. Additional anecdotal information had been received, primarily letters from physicians supporting inclusion of carbamazepine on the negative drug formulary. Further, Ciba-Geigy had submitted information related to six European studies purporting to establish the inequivalence of various carbamazepine formulations. The study committee found the information to contain "considerable inconsistency" and again elected not to recommend placement of carbamazepine on the negative drug formulary. The study committee suggested deferral of further consideration pending completion of a controlled study (the "Penry" study, which remains in progress) which may provide additional information related to alleged inequivalence of Tegretol and generic carbamazepine. On May 31, 1988, the study committee met and again declined to recommend that carbamazepine be included on the negative drug formulary. The study committee considered information, apparently erroneous, related to the Veteran's Administration Hospital System, but nonetheless chose to await the results of the Penry study. On November 1, 1988, four members of the Negative Formulary Committee, met by telephone conference call. The Negative Formulary Committee includes members of the Boards of Pharmacy and Medicine. At that time, the committee decided to recommend, to both boards, that carbamazepine be included in the negative formulary. There is limited evidence indicating the basis upon which this committee took the action. The committee may have considered the anecdotal information contained in letters submitted by physicians supporting the placement of carbamazepine on the formulary. It may have also considered a prior recall of a substantial number of generic carbamazepine dosages which apparently failed to meet FDA standards for tablet dissolution. The committee may have reviewed copies of adverse drug reports (ADRs) provided by Ciba-Geigy purporting to show adverse patient reactions to generic carbamazepine. At least one member of the committee may have considered telephone conversations with randomly selected physicians in his vicinity. Notice of the intent to add carbamazepine to the negative drug formulary was published in the December 16, 1988 edition of Florida Administrative Weekly. The Board of Pharmacy met on January 10, 1989. The Board of Medicine met on February 5, 1989. Both boards considered essentially the same materials and evidence related to the issue of placing carbamazepine on the negative drug formulary. Both boards elected to place carbamazepine on the negative drug formulary. Materials considered by the boards included physician letters, ADRs, and scientific articles relating to carbamazepine equivalency studies. The boards were aware of the recall of a significant quantity of generic carbamazepine tablets. There was discussion related to FDA standards and testing methods, and concern expressed related to interchangeability between carbamazepine products. There was discussion of Florida's Medicaid program, apparently, at least in part, based upon erroneous information, and on the carbamazepine-related issues being considered in at least one other state. Standards and specifications relating to the quality and purity of drugs available in the U.S. are established by the United States Pharmacopeia (USP), an independent entity, which has established such standards for carbamazepine. There is no evidence which would suggest that USP standards for carbamazepine are inadequate or erroneous. Such standards are found to be reasonable. The U.S. Food and Drug Administration (FDA) has responsibility for evaluation and control of prescription and generic drug products marketed in this country. The FDA utilizes the specifications and standards developed by the USP. As part of this responsibility, the FDA monitors the therapeutic equivalency of innovator and generic drugs marketed in the U.S., and makes specific findings as to such equivalence. Such findings are identified in the publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the "Orange Book." Drug products considered to be therapeutic equivalents by the FDA are pharmaceutical equivalents that can be expected to have the same therapeutic effect when administered to patients under the conditions specified in the labeling. As stated in the Orange Book, the FDA evaluates as therapeutically equivalent those products that meet the following general criteria: they are pharmaceutical equivalents in that they contain identical amounts of the same active drug ingredient in the same dosage form, and meet compendial or other applicable standards of strength, quality, purity, and identity; they are bioequivalent in that they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard matching both rate and extent; they are adequately labeled; and they are manufactured in compliance with Current Good Manufacturing Practice regulations. According to the FDA Orange Book, drug products are considered pharmaceutical equivalents if they contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration, and meet the same or comparable standards, as to strength, quality, purity, and identity. They may differ in characteristics such as color, flavor, shape, scoring configuration, packaging, preservatives; expiration time, and, within certain limits, labeling. Bioequivalent drug products are those which display comparable bioavailability when studied under similar experimental conditions. Bioavailability describes the rate and extent to which the active drug ingredient or therapeutic ingredient is absorbed from a drug product. Drugs are considered to be bioequivalent when the rate and extent of absorption of the test drug do not show a significant difference from the rate and extent of absorption of the reference drug, when such drugs are administered at the same therapeutic ingredient dose under similar experimental conditions. (There are further, unrelated standards by which bioavailabilty may be determined which are not relevant to this proceeding.) The FDA does not compare generic drugs for equivalency between generics, the assumption being that if the generics are biologically and therapeutically equivalent to the innovator reference, they will be equivalent among themselves. The greater weight of the evidence indicates that the assumption is reasonable. The FDA utilizes a series of two letter codes to identify therapeutic equivalency evaluation findings. The first letter of the code identifies whether a drug is considered to be therapeutically equivalent; the second letter identifies the basis for the equivalence evaluation. The drug products are listed in the Orange Book according to active ingredient, dosage form and strength. The FDA Orange Book identifies the 200 mg. oral tablet generic carbamazepine formulations and the 200 mg. oral tablet Tegretol brand carbamazepine, as being "AB" rated. As stated in the Orange Book, the AB evaluation generally denotes products that contain an active ingredient in a dosage form for which the submission of bioavailability or clinical data is required for approval or to permit therapeutic equivalence evaluations, and for which the applicant has provided adequate studies to establish the bioavailability and bioequivalence of its product. Otherwise stated, the generic carbamazepine products and Tegretol meet FDA therapeutic equivalence standards. The FDA finding of bioequivalence is based upon controlled tests performed on healthy live subjects. Such tests measure the maximum drug concentration in the blood stream (the "C-max") and the time required for the drug to reach such concentration levels (the "T-max"). Such statistical information is plotted, with the resulting graphic display (the "AUC," or "area under the curve") visually indicating the therapeutic effect the drug may be expected to provide. The generic drug test results are compared to the innovator brand test results. The suggestion that FDA tests should be performed on unhealthy persons so as to monitor effects in such situations was not supported by the greater weight of the evidence. The purpose of the tests is apparently to evaluate the expected therapeutic effect as measured by the C-max, T-max, and AUC, without complications induced by illness. In light of the purpose of the testing program, such evaluation procedures are reasonable. The FDA guidelines provide that a generic drug is considered bioequivalent when, at least 90% of the time the tests are performed (the "90% confidence interval"), the statistical indicators are within a 20% range of the innovator drug reference point. The permissible variance appears to reflect the use of live subjects for testing purposes and the fact that, even in tightly controlled situations, test results may be affected by factors related to individual body chemistry or metabolism. Even the same formulation may produce differing statistical data depending on extrinsic variables. The greater weight of the evidence establishes that the FDA guidelines utilized in determining therapeutic equivalence are reasonable. Although the FDA is reviewing the means by which determinations of equivalency for generic drugs are made, the evidence does not support a finding that the current FDA conclusions are erroneous or otherwise invalid. The evidence does not support a finding that the manner is which the FDA establishes therapeutic equivalence is unreasonable or inappropriate. The testing program utilized by the FDA in ascertaining equivalence is reasonable. Section 465.025(6)(a), Florida Statutes, provides that the party requesting the boards to include a drug on the negative formulary has the burden of proof to show why such inclusion should be made. In attempting to establish the alleged biological or therapeutic inequivalence between Tegretol and generic carbamazepine, Ciba-Geigy likely encouraged physicians to contact the boards through letter, and may otherwise have mobilized and demonstrated support for their position that carbamazepine should be placed on the negative formulary. A number of physicians sent letters to the Respondent addressing the issue of placing carbamazepine in the negative drug formulary. The letters provide anecdotal allegations of instances where therapeutic failures, generally seizures or side effects, are attributed to use of generic medication instead of Tegretol. The letters provide little evidence upon which a scientific determination can be based. There is no reason to presume that the anecdotal information contained within the letters is false. Although such anecdotal information gives cause for concern, concerned physicians can assure that brand Tegretol is used in filling prescriptions simply by writing "medically necessary" on the prescription, or by orally communicating such instructions in oral prescriptions. The letters are not sufficient to establish clinically significant biological or therapeutic inequivalence between Tegretol or generic carbamazepine. The Adverse Drug Reports (ADRs) do not establish that the alleged adverse reactions were related to the use of carbamazepine or substitution of the generic drug for Tegretol. Such reports are filed on a voluntary basis when a patient on medication experiences an unusual occurrence or incident which may by some means be related to use of the medication. ADRs are completed and submitted to the FDA by physicians or pharmacists who choose to do so. The FDA investigates the reports and monitors for trends which could indicate problems in manufacturing or equivalence. In fact, a reported adverse reaction may have no relationship to medication. The evidence did not establish that the FDA has identified biological or therapeutic equivalence concerns related to carbamazepine ADRs. Although the ADRs supplied by Ciba-Geigy to the boards imply that the alleged reactions resulted from substitutions of generic carbamazepine for Tegretol, no information is provided which specifically establishes a connection between the alleged reaction and the use of, or substitution of, generic carbamazepine. The bioequivalence of carbamazepine formulations is the subject of current scientific research, as reflected by a number of scholarly articles published in reputable medical journals, which suggest that various formulations may or may not be therapeutically equivalent. One of the studies compared liquid carbamazepine suspension to tablet form and concluded that the formulations were not equivalent due to absorption rates. However, the evidence indicates that the liquid suspension and the tablet formulation would not be classified as generically equivalent drugs in that they are not the same finished dosage form. Other studies have compared United States formulations of carbamazepine to other formulations which are not available within the United States or to formulations for which insufficient identification prevents determining availability. The evidence suggests that such foreign formulations are not commercially available within the U.S. Substitution by a Florida pharmacist of such a foreign formulation for a physician-prescribed carbamazepine product would be improper. The articles do not establish clinically significant biological or therapeutic inequivalence between generically equivalent carbamazepine products which may be used by a Florida pharmacist in dispensing medication. A recall of the generic carbamazepine tablets due to manufacturing difficulties does not establish biological or therapeutic inequivalence. It is possible for any pharmaceutical company to encounter problems related to manufacturing or storage which require the recalling of previously shipped dosages, as was apparently the case with the recall considered by the boards. Such recalls do not establish that the formulation of a drug is, in a clinically significant manner, biologically or therapeutically inequivalent. There is no clinically significant evidence which would establish that all generically equivalent carbamazepine products, containing the same active ingredient, finished dosage form, and strength are biologically or therapeutically inequivalent. The action of the Boards of Pharmacy and Medicine in placing carbamazepine on the negative drug formulary was arbitrary or capricious. The economic impact statement prepared as part of the Board of Pharmacy's rule adoption process clearly fails to address, or even mention, the economic impact to manufacturers and consumers of carbamazepine products. The summary of the estimated economic impact published in the December 16, 1988 edition of Florida Administrative Weekly minimally identifies the impact on consumers and manufacturers, however, the economic impact statement, contrary to statutory requirement, fails to properly include the estimated cost or economic benefit to all persons directly affected by rule adoption. The evidence indicates no more than cursory review of the economic impact of the rule adoption on manufacturers and consumers of the drug. The rule as adopted erroneously listed the referenced drug as carbomazepine, rather than the correctly spelled carbamazepine. There is no evidence that there was any confusion or harm resulting from the erroneous spelling, which apparently was the result of scrivener's error.
Findings Of Fact Respondent is a chiropractic physician licensed in the State of Florida, having been issued license No. 0001050. Respondent's office is located at 920 North Federal Highway, Hollywood, Florida. On July 31, 1980, Evelyn Yaxley, an elderly resident of Hollywood, was initially seen as a patient by Respondent. During that first visit, Respondent took a patient history, performed an examination, and administered a complete blood count and a urine test. He also dispensed to Mrs. Yaxley a bottle of Baldrian, a natural muscle relaxant, together with some vitamins. Respondent also performed an adjustment to Mrs. Yaxley's coccyx. At the end of the visit, Mrs. Yaxley was given a bill for $102.00 for Respondent's services, which she and her husband paid before leaving the office. On August 5, 1980, Mrs. Yaxley returned to Respondent for her next scheduled appointment, and was again accompanied by her husband. During the visit, Respondent informed Mrs. Yaxley that she had a urinary tract infection, which Respondent diagnosed partially from the laboratory test results obtained from the urine test taken on her previous visit. During the second visit, Mrs. Yaxley was taken into a treatment room where Respondent administered another adjustment. Dr. Kahn then left the treatment room and, in the presence of the patient's husband, instructed a receptionist who worked in his office to give Mrs. Yaxley four Azo Gantrisin tablets. The receptionist then entered the treatment room and gave four Azo Gantrisin tablets to Mrs. Yaxley, which Mrs. Yaxley took. At some point attendant to the administration of the Azo Gantrisin tablets, the Yaxleys questioned the Respondent about the advisability of administering Azo Gantrisin inasmuch as Mrs. Yaxley was sensitive to "sulfa drugs." The Yaxleys were assured, however, by Dr. Kahn that though the tablets were a sulfa drug derivative, they would be safe for her to take. The Yaxleys were then given, at Respondent's direction, a bottle of Azo Gantrisin tablets and instructed to have Mrs. Yaxley take two tablets every four hours. The Yaxleys paid Respondent $40.00 for his services rendered during the second visit. Azo Gantrisin is a product of two chemical entities, Phenaxopyridine and Sulfisoxazole, and is commonly referred to as a "sulfa drug." The drug is prescribed for treatment of urinary tract infections. Azo Gantrisin can cause adverse drug reactions, which are defined as any unintended or unexpected noxious effects that alter the structure or function of the body. Adverse drug reactions include allergic reactions, such as scratching, itching, swelling, and rashes. Other adverse drug reactions include swelling of the skin, difficulty in breathing, nausea, and vomiting. After the Yaxleys' visit to Respondent's office on August 5, 1980, they returned home, and later that same day Mrs. Yaxley took an additional dosage of Azo Gantrisin tablets in accordance with Respondent's instructions. Shortly thereafter, she became ill, experiencing severe nausea and vomiting. These symptoms continued throughout the night and into the next day. On the morning of August 6, 1980, Mrs. Yaxley was treated by her family physician for these symptoms, and was ultimately admitted to the hospital, where she remained for a period of approximately eight days. Mrs. Yaxley reported to both her family physician and hospital physicians that she had been given Azo Gantrisin tablets by a chiropractic physician and had taken them in the dosages reflected hereinabove. She also reported to hospital physicians, as she had indicated to Respondent earlier, that she was allergic to sulfa drugs. However, despite the similarities of the symptoms reported by Mrs. Yaxley to those which indicate an adverse reaction to sulfa drugs, tests run while she was hospitalized are inconclusive on the question of whether she in fact suffered such a reaction. These tests neither confirm nor rule out such an adverse reaction. Azo Gantrisin is a legend drug required to be dispensed or administered only by a physician. A chiropractic physician is expressly prohibited from administering or dispensing any legend medicine or drug. Respondent has never had an administrative complaint filed against him by the Department of Professional Regulation or the Board of Chiropractic prior to the instant Administrative Complaint.
Findings Of Fact The Petitioner, Department of Professional Regulation, Board of Pharmacy, seeks to take disciplinary action against Respondent based on its complaint filed February 24, 1982. Respondent, Herbert Lazarus, is a licensed pharmacist in the State of Florida and is holder of license number 5426. During times material herein, Respondent was employed at Don's Discount Drugs, 6234 S. Dixie Highway, South Miami, Florida. Respondent was the managing pharmacist of Don's Discount Drug Pharmacy Department throughout his employment and particularly during the period October 23, 1981 through January 6, 1982. The Drug Enforcement Administration, Department of Justice, conducted two audits to determine the quantities of Methaqualone dispensed from Don's Discount Drugs. The initial audit covered the period August 4, 1981 through October 23, 1981. The second audit covered the period October 23, 1981 through January 6, 1982. The first audit revealed that during the period August 4, 1981 through October 23, 1981, Don's Discount Drugs dispensed 68,738 300 milligram tablets of Methaqualone on 1,114 prescriptions. The second audit revealed that during the period October 23, 1981 through January 6, 1982, Don's Discount Drugs dispenses 133,667 Methaqualone 300 milligram tablets on 3,081 prescriptions from 6 physicians writing 2,241 of those prescriptions. The dosage appearing on more than 90 percent of the prescriptions relating to both audit periods is 45 units per prescription. The audit further revealed that the Methaqualone prescriptions constituted over 95 percent of all Schedule II prescriptions and more than one half of all prescriptions filled at Don's Discount Drugs. During times relevant herein, Methaqualone was a Schedule II controlled substance by virtue of statutory categorization in Section 893.03(2)(a)(4)(c)(5), Florida Statutes (1981). As such, Methaqualone is a substance which has a high potential for abuse and has severely restricted medical use. Abuse of Methaqualone leads to severe psychological or physical dependence. Methaqualone was designed to induce sleep. The drug generally should not be utilized for more than a period of three (3) weeks. (Testimony of John B. Handwerker, M.D.) Louis Fisher, a trained pharmacist, received his Bachelor of Science degree in Pharmacy from Hamden College of Pharmacy in Massachusetts. During the past eleven years, he has been a Federal Drug Enforcement Administration agent whose primary responsibility is to investigate pharmacists who handle and dispense Schedule II substances. Additionally, Mr. Fisher participated in the drafting of regulations that are now part of the federal Controlled Substances Act. Mr. Fisher was tendered and received as an expert herein in pharmacy. Mr. Fisher was presented with a hypothetical question encompassing the facts as presented herein respecting the dispensation of Methaqualone by the Respondent as managing pharmacist for Don's Discount Drugs during the period October, 1981 through January, 1982. Utilizing those facts, Mr. Fisher opined that such a managing pharmacist who permits the dispensation of Methaqualone in the amounts as described herein above would amount to the dispensing of Methaqualone in a manner outside the course of the professional practice of pharmacy; in a manner not in the good faith practice of pharmacy; in a manner considered to be excessive and inappropriate in the practice of pharmacy and not in good faith in dispensing those amounts of Methaqualone. An examination of one of the medical doctors who was prescribing the drug Methaqualone, was one Camila Dwyer, a stress clinic doctor. A review of Dr. Dwyer's prescribing patterns reveals that on an average day during the period during late December, 1981, Dr. Dwyer prescribed an average of 20 prescriptions which were tendered to be filled by Respondent at Don's Discount Drugs. The average prescription was for a quantity of 40 tablets of 300 milligram Methaqualone tablets. Mr. Fisher reviewed the prescribing pattern of Dr. Dwyer and expressed his opinion that Respondent, as managing pharmacist for Don's Discount Drugs, should have become alerted and inquired into Dr. Dwyer's prescribing practices since, in his opinion, the prescriptions were of doubtful origin and should have been refused by the Respondent and/or the filling pharmacist. Dr. John B. Handwerker, M.D. is a doctor who has practiced as such in Florida in excess of 31 years. Dr. Handwerker attended the University of Tennessee School of Medicine and trained at Jackson Memorial Hospital, Miami, Florida. Dr. Handwerker is an Assistant Professor of Clinical Pharmacology at the University of Miami Medical School. Dr. Handwerker was tendered and received herein as an expert in the dispensing of Schedule II drugs and in pharmacology. The recommended dosage for Methaqualone is 300 milligrams at bedtime used to induce sleep for a period not to exceed two to three weeks. This time period is used inasmuch as the effectiveness of the drug ceases following an approximate period of two weeks due to the pharmacological makeup of Methaqualone. Dr. Handwerker was also requested to review the prescribing patterns of Dr. Camila Dwyer. (Petitioner's Composite Exhibit 2) Dr. Handwerker determined, after reviewing Dr. Dwyer's prescribing pattern, that Dr. Dwyer's prescriptions should not have been accepted by the managing pharmacist at Don's Discount Drugs due to her abnormal prescribing pattern which should have been reported to the appropriate regulatory authorities. Methaqualone, a known street drug, is highly abused in south Florida. It is incumbent upon a pharmacist to question a doctor's prescribing patterns for drugs which are known to be abused. Jacob Hodus, a registered pharmacist since June, 1951, is an equal partner in Sandy's Drug, Inc., North Miami Beach, Florida. Mr. Hodus has practiced at Sandy's Drugs in excess of 28 years. Mr. Hodus was tendered and received as an expert herein in the practice of pharmacy in Florida. Mr. Hodus reviewed the prescribing patterns of the doctors who had prescribed Methaqualone and presented to Don's Discount Drugs to be filled. Based on what Mr. Hodus considered to be a pharmacist's obligation to report questionable prescribing practices to the appropriate regulatory agencies, he expressed the opinion that the Respondent, as manager of Don's Discount Drugs, should not have continued to fill the prescriptions for Methaqualone and that for him to continue to do so would not be either acting in the normal course of the professional practice of pharmacy or in the good faith practice of pharmacy. The Respondent's Position Herbert Lazarus, Respondent herein, is a registered pharmacist who has practiced that profession since 1947. Respondent has worked for numerous hospitals and drug stores and is presently still employed at Don's Discount Drug Store. At one time, Respondent owned Shadowlawn Pharmacies, but sold it due to medical problems. Respondent has served as the Chief Pharmacist at several hospitals including Victoria Hospital. From the period August 25, 1981 through May 3, 1982, Respondent served as a pharmacist for Stuart Levine, the former owner of Don's Discount Drugs. Respondent gave conflicting testimony as to the time that he became the manager of Don's Discount Drugs. At one point in his testimony, Respondent states that he became manager during mid-December, 1981 while, on other occasions, he testified that he became manager during January, 1982. Respondent avers that he was only a pharmacist employee and that all policy decisions respecting whether or not Methaqualone prescriptions should be filled were made by Stuart Levine. 2/ Stuart Levine expired on May 3, 1982. Thereafter, Respondent changed the policy of filling prescriptions for Methaqualone. It was noted, however, in this regard, that as of July 1, 1982, Methaqualone became a Class I drug and, therefore, is no longer sold in retail pharmaceutical outlets. Respondent expressed his belief that a pharmacist, in general, has no obligation to question a physician's prescribing practices. Respondent considered his primary responsibility to be that of verifying whether or not the prescription was, in fact, completed by a duly licensed physician authorized to dispense Schedule II drugs and whether that person presenting the prescription is the one for whom it was written. Once satisfied that those conditions were met, Respondent would fill that prescription and "keep his nose out of it." Respondent never inquired by physicians, whether the drug Methaqualone was medically necessary for treatment. Respondent maintained a detailed patient profile system. That system was used to monitor the dispensing of Schedule II substances. That system insured that Respondent had, at minimum, constructive knowledge of all the dispensing activity at Don's Discount Drugs. Prescriptions of doubtful origin were not filled as were prescriptions where the physical condition of the patient could not be readily determined. Respondent also would not fill a prescription where a doctor's license was in jeopardy. Respondent feels that he took the usual necessary steps to insure that the prescriptions for Methaqualone were properly filled. Don's Discount Drugs received an unusually large number of prescriptions for Methaqualone due to the large number of pharmacists who would not fill the prescriptions and due to the reasonable rate that Respondent charged for each Methaqualone tablet, i.e. $.50 versus the charges of approximately $1.00 to $1.50 per 300 milligram tablet at other pharmacies. Finally, Respondent considered that he was not obligated to second-guess a doctor's medical opinion where Methaqualone was prescribed. Respondent acknowledged that Methaqualone is a dangerous drug and has a high potential for abuse.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is hereby recommended that the license of Respondent Herbert Lazarus, number 5426, be REVOKED. RECOMMENDED this 9th day of May, 1984, at 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 9th day of May, 1984.
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
The Issue The issues are whether Respondent obtained Oxycontin by using a forged prescription, in violation of Section 464.018(1)(h), Florida Statutes, and Rule 64B9-8.005, Florida Administrative Code, which prohibit unprofessional conduct, and in violation of Section 464.018(1)(i), Florida Statutes, which prohibit the unauthorized possession, sale, or distribution of controlled substances; and whether Respondent's use of Oxycontin affects her ability to practice nursing with reasonable skill and safety, in violation of Section 464.018(1)(j), Florida Statutes, which prohibits the inability to practice nursing with reasonable skill and safety by reason of illness or use of alcohol, drugs, narcotics, or chemicals or as a result of any mental or physical condition. If so, an additional issue is what penalty should be imposed.
Findings Of Fact Respondent is a licensed registered nurse, holding license number RN 521142. She has been so licensed for 31 years. Respondent's long career in nursing has featured dedication, hard work, commitment, and competence. The record does not reveal any past discipline. For most of Respondent's professional career, starting in 1971, she has worked at Indian River Memorial Hospital in Vero Beach. Respondent has worked in various capacities at the hospital, including the emergency room and operating room. Respondent later helped develop a neurological unit at the hospital. Starting in 1980, she worked for a couple of years at Vero Orthopedics. Since 1997, Respondent has worked on a contract basis at the Indian River Memorial Hospital, although her present physical infirmities, partly described below, prevent her from working at present. In May 2000, Respondent injured her back while moving a heavy patient in the hospital. A couple of months later, Respondent underwent a laminectomy to relieve the pain from two herniated disks. Six weeks after the surgery, Respondent reinjured her back and had to undergo additional surgery. Six weeks after the second surgery, Respondent, who was not doing well, left her job at the orthopedic clinic and took a less strenuous job. One month after doing so, Respondent was still experiencing pain when she got into and out of cars. In June 2001, Respondent underwent a third operation, in which the surgeon fused two injured vertebrae. The surgery obtained access to the vertebrae by a posterior incision running from the breast to the pubis. The surgery also required a hip bone graft, thus necessitating an incision to the hip. The recovery from this excruciatingly painful surgery was difficult, and Respondent has not yet returned to work, although she is nearing the point at which she can perform some nursing-related work, such as teaching. At present, she still has difficulty walking or standing. When discharging Respondent from the hospital in late June 2001, Dr. Gomez prescribed her Oxycontin for pain. Dr. Gomez was covering for Respondent's neurosurgeon, Dr. Magana. Later, Dr. Cunningham, a pain management specialist and Respondent's family physician, resumed the care of Respondent. Dr. Cunningham continues to monitor Respondent and treat her pain. On direct examination, Respondent testified that she has not taken Oxycontin since December 2001. (However, on August 9, 2002, Respondent told her certified addictions professional that she had not taken any Oxycontin since March 2001.) Respondent testified that, after Oxycontin, she took no pain medication besides nonsteroidal anti-inflammatory medications and steroids. However, on cross-examination, Respondent admitted that she takes Methadose as needed, pursuant to a prescription from Dr. Cunningham. Respondent testified that he switched her from Oxycontin in July 2002. Respondent filled the Methadose prescription at a different drug store than the one that she has used for her other prescriptions. On October 5, 2001, Respondent presented a forged prescription to a different drug store than the one she has used for her other prescriptions. The prescription was for fifty 20- mg. Oxycontin tablets, which Respondent picked up two days later. Respondent fraudulently obtained the Oxycontin for her own use. Oxycontin is an analgesic opioid and a schedule II controlled substance. It is highly addictive and presently among the most commonly abused controlled substances. Oxycontin can produce a feeling of short-lived euphoria, as well as impaired cognitive functioning and impaired judgment. Methadose, a form of methadone, is a synthetic analgesic. It is also used in the detoxification process undergone by heroin addicts. Petitioner has proved by clear and convincing evidence that Respondent engaged in unprofessional conduct in her acquisition of the Oxycontin by using a forged prescription and that Respondent unlawfully possessed a controlled substance. Petitioner has not proved by clear and convincing evidence that Respondent's use of Oxycontin affects her ability to practice nursing with reasonable skill and safety. First, Petitioner did not prove by clear and convincing evidence that Respondent still uses Oxycontin. It appears likely that she may have substituted Methadose for Oxycontin to manage her pain. It is unclear from the present record whether Respondent's use of Methadose is also to assist her in overcoming an addiction to Oxycontin. But even if Petitioner had pleaded Methadose rather than Oxycontin, the record does not reveal the extent to which Respondent presently uses Methadose. For the reasons stated in the preceding paragraph, the relevance of the Methadose is not to prove the third count of the Administrative Complaint, but to underscore the risk that Respondent may pose if she practices nursing at present. Respondent was not candid at the hearing. She was not candid about the October 2001 incident. She was not candid about the recent use of Methadose and was evasive about the drug's properties. The two-hour evaluation that Respondent underwent by a certified addictions professional was cursory and curiously deferential to Respondent. This remarkable evaluation is entitled to absolutely no weight whatsoever. The opinion of the certified addictions professional that Respondent does not suffer from a drug abuse or dependency may or may not be true, but, if true, the result is a chance occurrence, rather than a professional conclusion following the comprehensive collection of relevant, reliable data and the careful, informed analysis of such data. The safeguards provided by the pretrial intervention program, into which Respondent entered after her arrest for the fraudulent acquisition of the Oxycontin, are inadequate. The random drug tests always occur on Tuesdays, just not every Tuesday. The assurances that ensue from Respondent's apparent compliance with the conditions of her probation, which include negative urinalyses, are meaningful, but not sufficiently rigorous to provide the necessary protection to a nurse's patients. On December 26, 2001, Petitioner entered an emergency suspension order in this case. The record amply demonstrates that Respondent will suffer considerable financial distress if denied the opportunity to practice her profession. However, Respondent's lack of candor precludes a detailed analysis of the safeguards in her current monitoring program and a detailed prescription of what, if any, additional safeguards would be required to permit any discipline short of a suspension. In its proposed recommended order, Petitioner seeks a suspension until lifted pursuant to, and subject to the conditions set by, an evaluation coordinated by the Intervention Project for Nurses (IPN); treatment as recommended by the IPN; probation for three years if no treatment is recommended by the IPN; an administrative fine of $750; a reprimand; and the assessment of costs of the investigation and prosecution.
Recommendation It is RECOMMENDED that the Board of Nursing enter a final order finding Respondent guilty of violating Section 464.018(1)(i), Florida Statutes, and imposing a penalty of a $250 administrative fine, a suspension until lifted pursuant to, and subject to the conditions set by, an evaluation coordinated by the IPN; treatment as recommended by the Intervention Project for Nurses; probation for three years if no treatment is recommended by the Intervention Project for Nurses; and the assessment of costs of the investigation and prosecution, upon remand, if necessary. DONE AND ENTERED this 20th day of December, 2002, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of December, 2002. COPIES FURNISHED: Dan Coble, RN PhD CNAA C, BC Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C02 Tallahassee, Florida 32399-3252 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Amy M. Pietrodangelo Assistant General Counsel Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Suzanne H. Suarez Suzanne Hope Suarez, P.A. The Legal Building 447 3rd Avenue North, Suite 404 St. Petersburg, Florida 33701-3255
