STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

AGENCY FOR HEALTH CARE )

ADMINISTRATION, )

)

Petitioner, )

)

vs. ) Case No. 96-4946

)

LAWRIE B. GLICKMAN, D.D.S., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a final hearing was conducted in this matter by David M. Maloney, Administrative Law Judge of the Division of Administrative Hearings, on April 30, 1997, by video conference. The administrative law judge presided from the Department of Management Services in Tallahassee, Florida, and the parties and witnesses participated from Tampa, Florida.

APPEARANCES

For Petitioner: Natalie Duguid, Esquire

Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 32308-14229

For Respondent: Michael L. Kinney, Esquire

Post Office Box 18055 Tampa, Florida 33679-8055

STATEMENT OF 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?

PRELIMINARY STATEMENT

On October 17, 1996, the Division of Administrative Hearings received a letter from the Agency for Health Care Administration under the signature of Senior Attorney, Natalie Duguid. The letter requested assignment of an Administrative Law Judge to conduct formal proceedings pursuant to Section 120.57(1), Florida Statutes, necessitated by an Election of Rights Form signed by Respondent, Lawrie B. Glickman, D.D.S., in which he contested all of the facts in an Amended Administrative Complaint. Attached to the letter are copies of both the Election of Rights Form and the Amended Administrative Complaint.

The case was assigned to Administrative Law Judge, Richard

1. Hixson, and later re-assigned to the undersigned. On April 23, 1997, a Prehearing Stipulation was filed in which the parties limited the issues to whether Dr. Glickman violated Section 466.028(1)(q), Florida Statutes. The Agency agreed to dismiss Count I of the Administrative Complaint as well as any charges that Dr. Glickman violated paragraphs (m), (p), and (y) of subsection (1) in Section 466.028, Florida Statutes.

   Through operation of the pre-hearing stipulation, as well as the Agency's announcement of dismissal of portions of the Amended Administrative Complaint at final hearing, the Agency took the position that Dr. Glickman should be disciplined only pursuant to "three paragraphs of count two of the amended administrative complaint[,] [t]hose [being] . . . paragraphs thirteen, fourteen and fifteen," (Tr. 7,) "the (q) violations[.]" (Tr. 6).

   Dr. Glickman, on the other hand, both at hearing and in the pre-hearing stipulation took the position contrary to the charges in paragraphs 13, 14, and 15 of the amended administrative complaint or that, while he had written the prescriptions, he had not "prescribed for himself," (Emphasis Supplied) the substances named.

   At hearing, the Agency presented the testimony of three witnesses: Doug Healy, R.Ph.; John Taylor, R.Ph.; and Blayne Gumm, D.D.S., M.A.G.D. The Agency offered two exhibits, both of which were accepted into evidence. Dr. Glickman presented his own testimony as well as the testimony of another witness, Ms.

   Sonia Acosta. He offered two exhibits, both of which were admitted into evidence.

   On May 12, 1997, the Agency filed a Motion for Official Recognition of portions of the Florida Statutes and Title 21, Code of Federal Regulations, Chapter II, Part 1306. No response to the motion was filed. Official recognition is hereby taken of the laws attached to the motion.

   The parties submitted proposed recommended orders: the agency, on May 21, 1997; Dr. Glickman, six days later, on May 27, 1997.

   FINDINGS OF FACT

   
   

   The Parties

   
   

   1. 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.

   2. 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

      
      

   3. 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.

   4. "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.

   5. 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.

   6. 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.

   7. 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).

   8. 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.

   9. The syrup has additional uses of value during dental procedures. It depresses coughing, nausea, and vomiting.

      Testosterone Cypionate Injection

      
      

   10. 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.

   11. 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.

   12. Testosterone has been accepted for use in Europe in the healing of gangrenous tissues of diabetic patients or patients with cardiovascular disease.

   13. 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.

   14. 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.

   15. 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

       
       

   16. 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

       
       

   17. 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.

   18. 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.

   19. 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.

   20. 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."

   21. 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

       
       

   22. 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.

   23. Rather, Dr. Glickman wrote the three prescriptions for general office use and solely for such use.

   24. 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.

   25. 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.

   26. 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

       
       

   27. 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.

   28. 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.

       
       

       CONCLUSIONS OF LAW

       
       

   29. The Division of Administrative Hearings has jurisdiction over the subject matter and the parties to this case. Section 120.57(1), Florida Statutes.

   30. Disciplinary licensing proceedings are penal in nature. State ex rel. Vining v. Florida Real Estate Commission, 281 So.2d

       487 (Fla. 1973). If it hopes to suspend or revoke Dr. Glickman's license through this proceeding, the Agency must prove by clear and convincing evidence the violations of Section 466.028(1)(q), Florida Statutes, it alleges Dr. Glickman committed. Department of Banking and Finance v. Osborne Stern and Company, 670 So.2d 932 (Fla. 1996).

   31. Section 466.028(1)(q), Florida Statutes, reads as follows:

       466.028 Grounds for disciplinary action; action by the board.-

       
       

       (1) The following acts shall constitute grounds for which the disciplinary actions specified in subsection (2) may be taken:

       
       

       * * *

       (q) Prescribing, procuring, dispensing, administering any medicinal drug appearing on any schedule set forth in Chapter 893, by a dentist to himself, except those prescribed, dispensed, or administered to the dentist by another practitioner authorized to prescribe them.

       
       

   32. While Dr. Glickman did not write the three prescriptions at issue "for" himself (the wording used in the

       Amended Administrative Complaint) in the sense they were intended for his personal use, he did prescribe them "to" himself, in the sense that the prescriptions are written in his name. He did so in order to obtain the prescribed substances for legitimate office uses without having to follow the proper procedure of obtaining them by ordering from a licensed wholesaler.

   33. There is no decision or case law that has been brought to the attention of this administrative law judge that deals with improper prescriptions by a dentist to himself for the purpose of obtaining scheduled controlled substances quickly for use in the practice of dentistry so as to avoid the delay of the proper method of obtaining them.

   34. Rule 59Q-13.005(3)(u), Florida Administrative Code, provides a range of penalties for violations of paragraph (q) of the "grounds for discipline" statute. The range is from probation through restriction of practice to suspension or revocation. But, it appears from this record that Dr. Glickman's three violations of Section 466.028(q), Florida Statutes, are at most technical. Certainly, they are not deserving of punishment the Agency seeks in this case: license suspension for three months, probation for a period of one year under undelineated conditions to be imposed by the board, a reprimand and payment of administrative costs of $3,000.

   35. Dr. Glickman did not follow proper procedure. He prescribed controlled substance to himself on three occasions so

that he could obtain them rapidly for use in his office without the delay entailed in following established procedure. It was a violation of paragraph (q) in Section 466.028(1), Florida Statutes, each of the three times he did so. The violations were as to the strict letter of the law. Dr. Glickman's carelessness, however, did not violate the spirit or underlying intent of the statute. In order to ensure that he understands the problem caused by improper procedure he should not suffer a penalty of more than a short period of probation. A fine to be contributed to the administrative costs of the Agency is appropriate but three thousand dollars is excessive. A fine in the nature of

$250 per charge is more than adequate.

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

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within 15 days from the date of this recommended order. Any exceptions to this recommended order must be filed with the agency that will issue the final order in this case.

Docket for Case No: 96-004946

Orders for Case No: 96-004946