STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )

)

Petitioner, )

)

v. ) CASE NO. 82-3472

)

LAKE MARY PHARMACY, )

)

Respondent. )

) DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )

)

Petitioner, )

)

v. ) CASE NO. 82-3473

)

AUBREY MORAN, )

)

Respondent. )

)

RECOMMENDED ORDER

This matter came on for hearing in Sanford, Florida, before the Division of Administrative Hearings by its duly designated Hearing Officer, Robert T. Benton, II, on February 27, 1984. The Division of Administrative Hearings received the transcript of proceedings on March 22, 1984. The parties proposed recommended orders were received on April 3 and May 2, 1984. The parties were represented by counsel:

APPEARANCES

For Petitioner: Bruce D. Lamb, Esquire

130 North Monroe Street Tallahassee, Florida 32301

For Respondent: W. C. Hutchison, Jr., Esquire

Hutchison & Mamele

230 North Park Avenue Sanford, Florida 32771

By administrative complaints filed December 6, 1982, petitioner alleged that respondent Lake Mary Pharmacy "is a community pharmacy . . . [holding] permit number 0007301," that respondent Aubrey Moran holds "license number 0010982," and that Aubrey Moran was "at all times material . . . the managing pharmacist . . . and the dispensing pharmacist, employed at the Lake Mary Pharmacy."

The administrative complaints allege that respondents "from or about September 9, 1981 until December 3, 1981 . . . provided Robert Bevier, M.D., with seven (7) 1/4 oz. bottles of Cocaine HCL flakes"; "from or about August 9, 1982 until September 8, 1982 . . . provided Robert Bevier, M.D., with four (4) Demerol 20 cc. injectable ampules"; "on or about September 9, 1982 . . . provided Robert Bevier, M.D., with 100 Dilaudid tablets"; "from or about May 1, 1981 until August 30, 1982 . . . dispensed a total of" 387 Demerol 100 tablets, of which 337 "were dispensed on prescriptions written by Robert Bevier, M.D., in the period from or about July 14, 1982 until August 30, 1982 and that many of the prescriptions were picked up personally by Dr. Bevier"; that "all of the aforementioned drugs are . . . Schedule II substances, pursuant to Chapter 893, Florida Statutes"; that Aubrey Moran, and, through him, Lake Mary Pharmacy, knew "at all material times . . . that Dr. Bevier had had action taken against him by the Florida Board of Medical Examiners for alleged alcoholism and drug abuse"; all in violation of Sections 465.016(1)(e) and (i), 465.023(1)(c) and 893.04(1), Florida Statutes."

Both administrative complaints were subsequently amended to delete the allegation of knowledge of action taken against Dr. Bevier and to substitute the allegation that Aubrey Moran, and through him, Lake Mary Pharmacy, "on May 28, 1982 . . . was informed that dr. Bevier was under investigation by the Department of Professional Regulation for alleged self-prescribing of Schedule II drugs."

The parties stipulated to most of the pertinent facts and submitted a memorandum and proposed recommended orders, including proposed findings of fact on disputed matters, which have been adopted, in substance, except where unsupported by the weight of the evidence, immaterial, cumulative, or subordinate.

FINDINGS OF FACT

1. At all pertinent times, Aubrey Moran, who holds a Florida pharmacist's license, No. 0010982, was the managing pharmacist and the dispensing pharmacist at Lake Mary Pharmacy, 185 North Country Club Road, Lake Mary, Florida, a community pharmacy that holds permit No. 0007301. Half a block away from Lake Mary Pharmacy Robert L. Bevier, M.D., who was then Lake Mary's "principal general practitioner," had his office.

   
   

   COCAINE

   
   

2. In the fall of 1981, Dr. Bevier brought respondent an article from a medical journal, which read, as follows:

   
   

   Make Your Own TAC; It Works Well

   
   

   Atlanta--An Atlanta emergency physician has reported good results with a topical anesthetic called TAC made of tetracaine, cocaine, and epinephrine.

   
   

   Dr. Michael Kessler, director of a seminar on Outpatient Surgical Techniques for the Non-Surgeon, said his group at a freestanding emergency clinic sees large numbers of pediatric patients, and TAC has worked well as a topical anesthetic for children as well as adults.

   The recipe for TAC (taken from the January 1980 Journal of the American College of Emergency Physicians, according to Kessler) calls for 300 mg. tetracaine hydrochloride powder; one-fourth ounce (7,090 mg.) cocaine flakes; 30 cc 1:1000 inject epinephrine, and distilled water.

   
   

   The tetracaine is dissolved in a small amount of distilled water; the epinephrine and cocaine added; and the mixture combined with distilled water to make 60 cc volume. It should be stored in a brown bottle and has a shelf-life of 21 to

   30 days.

   
   

   Dr. Bevier asked Mr. Moran to compound some of this mixture.

   
   

3. Mr. Moran did not keep cocaine in stock ordinarily, but he acquired some from a wholesaler and dispensed 60 cc. amounts of the TAC solution to Dr. Bevier on three occasions. On each occasion Dr. Bevier wrote a prescription for himself on a form on which "AB 8796510" appeared just under his signature. The prescriptions were dated September 8, November 3 and November 23, 1981, and were filled on the dates written, except for the first, which was not filled until September 14, 1981, perhaps because of a delay in obtaining ingredients. Mr. Moran was under the impression that Dr. Bevier was using the solution as a local anesthetic in his practice for procedures like the removal of warts. Solutions of this type are also used to anesthetize mucous membranes. Cocaine in solution with epinephrine is of no use to an abuser. Deposition of Charles L. Park, p.

1. Testimony of Respondent. (T. 112)

   
   

   1. In early December of 1981, Dr. Bevier asked Mr. Moran for the TAC ingredients to keep on hold in his office so that he could mix the solution up along, as needed. Mr. Moran's only information about shelf life was what he had read in the article from the medical journal Dr. Bevier had shown him. He did in fact deliver the ingredients to Dr. Bevier, including four quarter ounce packages of cocaine hydrochloride flakes, on December 3, 1982. Dr. Bevier signed the official Drug Enforcement Administration form (DEA 222) required in connection with this transaction, and delivered it to the pharmacy.

      
      

      INVESTIGATOR ARRIVES

      
      

   2. After the cocaine flake purchases, Will A. Merrill, an investigator for petitioner Department of Professional Regulation visited Mr. Moran in the course of investigating Dr. Bevier. On May 27 and 28, 1982, Mr. Merrill examined respondent's records, and talked to Mr. Moran. Precisely what was said is a matter of dispute. At the very least, Mr. Merrill advised Mr. Moran that irregularities in Dr. Bevier's record keeping regarding Schedule II drugs were being looked into. Cocaine, Demerol (Meperidine) and Dilaudid are all controlled substances, and are listed on Schedule II in Chapter 893, Florida Statutes. The investigation culminated in an emergency suspension of Dr. Bevier's license to practice medicine on September 12, 1982. Thereafter the investigation of respondents began.

      DEMEROL AND DILAUDID

      
      

   3. Lige Williams, a cancer victim, was Dr. Bevier's stepfather. On July 14, 1982, and again on August 2, 1982, Mr. Moran filled prescriptions for Mr. Williams written by Dr. Bevier, each for sixty 100 milligram tablets of Demerol. He dispensed the medicine to Mr. Williams.

      
      

   4. On August 9, 1982, Mr. Moran dispensed a 20 milliliter ampule of Demerol to Dr. Bevier for office use after Dr. Bevier signed the appropriate Form 222. Dr. Bevier himself came into Lake Mary Pharmacy with a prescription for one hundred 100 milligram tablets of Demerol for Lige Williams on August 13, 1982, and Mr. Moran filled the prescription. On August 16, 1982, Mr. Moran dispensed a second 20 milliliter ampule of Demerol to Dr. Bevier for office use, again after Dr. Bevier signed the appropriate Form 222. Three days later Dr. Bevier presented another prescription for a hundred 100 milligram tablets of Demerol for Lige Williams, which Mr. Moran filled. On August 26 and September 8, 1982, Dr. Bevier signed two more Form 222s and Mr. Moran dispensed two more

      20 milliliter ampules of Demerol for office use. Dr. Bevier told Mr. Moran that the Demerol ampules were "primarily . . . for Mr. Williams' use." (T. 103) The parties stipulated that Mr. Moran dispensed another fifty 100 milligram tablets of Demerol at some time "from or about May 1, 1981 until August 30, 1982" to unspecified person(s) under unspecified circumstances.

      
      

   5. On September 9, 1982, Mr. Moran filled a prescription Dr. Bevier wrote and personally presented for Lige Williams for 100 four milligram tablets of Dilaudid. When Mr. Moran questioned the quantity of tablets, Dr. Bevier said that Lige Williams was leaving Lake Mary to go back to his own home and that he "want[ed] him to have enough tablets to get him up there and hold him until he can be seen by a physician up there." (T. 93)

      
      

   6. Dilaudid and Demerol in the sequence and dosages to be inferred from the prescriptions Mr. Moran filled for Mr. Williams, even assuming Mr. Williams received the full contents of all four ampules, are commonly and appropriately prescribed for terminally ill cancer patients, according to the uncontroverted medical testimony.

      
      

      CONCLUSIONS OF LAW

      
      

   7. Section 465.016(2), Florida Statutes (1983), authorizes petitioner to suspend or revoke a pharmacist's license, fine or reprimand a pharmacist or place a pharmacist on probation whenever it can be shown that the pharmacist has been guilty of any of the acts specified in Section 465.016(1), Florida Statutes (1983). The administrative complaint alleges that respondent Moran violated Section 465.016(1)(e) and (i), Florida Statutes (1983), by dispensing cocaine, Demerol and Dilaudid at Dr. Bevier's direction and to him personally for the most part. The statute proscribes:

      
      

      (e) Violating any of the requirements of this chapter; chapter 499, known as the "Florida Drug and Cosmetic Act"; 21 U.S.C. ss. 301-392, known as the "Federal Food, Drug, and Cosmetic Act"; 21

      U.S.C. ss. 821 et seq., known as the Federal Drug Abuse Act; or chapter 893. (footnote omitted)

      * * *

      (i) Compounding, dispensing, or distributing a legend drug, including any controlled substance, other than in the course of professional practice,

      it shall be legally presumed that the compounding, dispensing, or distributing of legend drugs in excessive or inappropriate quantities is not in the best interests of the patient and is not in

      the course of the professional practice of pharmacy. Section 465.016(1), Florida Statutes (1983).

      
      

      With respect to Section 465.016(1)(e), Florida Statutes (1983), petitioner has invoked Section 893.04(1), Florida Statutes (1983), which provides:

      
      

      A pharmacist, in good faith and in the course of professional practice only, may dispense controlled substances upon a written or oral prescription of a practitioner, . . . .

      
      

      Citing CFR 1306.04(a) for the first time in its proposed recommended order, petitioner proceeds on the theory that Mr. Moran did not dispense these controlled substances "in good faith and in the course of professional practice only."

      
      

   8. Section 465.023, Florida Statutes (1983), authorizes disciplinary action against pharmacy permittees on grounds that include, in Section 465.023(1)(c), Florida Statutes (1983), on which petitioner relies in the present case, grounds identical to those set forth with respect to pharmacists in Section 465.016(1)(e), Florida Statutes (1983), quoted above.

      
      

   9. In a matter of grave as license revocation proceedings, the duty allegedly breached by the licensee must appear clearly from applicable statutes or rules or have a "substantial basis," Bowling v. Department of Insurance, 394 So.2d 165, 173 (Fla. 1st DCA 1981), in the evidence. Disciplinary licensing proceedings like the present case are potentially license revocation proceedings, even in the absence of a recommendation of revocation, since the penalty for the infraction alleged lies within the discretion of the disciplining authority, if allegations of misconduct are established at a hearing. Florida Real Estate Commission v. Webb, 367 So.2d 201 (Fla. 1979). License revocation proceedings have been said to be "'penal' in nature." State ex rel. Vining v. Florida Real Estate Commission, 281 So.2d 487, 491 (Fla. 1973); Kozerowitz v. Florida Real Estate Commission, 289 So.2d 391 (Fla. 1974); Bach v. Florida State Board of Dentistry, 378 So2d 34 (Fla. 1st DCA 1979) (reh. den. 1980).

      
      

   10. This is not a case of physician's prescribing for himself or for office use. There was no allegation that respondents' dispensing controlled substances to a physician for office use was a per se violation of law. Dr. Bevier used what were apparently the appropriate forms required by the Drug Enforcement Administration for physicians who use controlled substances in their office practices. There was, in any event, no allegation otherwise. The contention is that the drugs were dispensed other than in good faith and in the course of the professional practice of pharmacy. The proof did not establish this. The first three quarter ounces of cocaine were dispensed in a solution with epinephrine, a form not subject to abuse, according to the uncontroverted testimony. Later a full ounce of unadulterated cocaine flakes was dispensed to Dr. Bevier along with the other ingredients necessary to make TAC, the mixture that would render the cocaine not subject to abuse. This may well have created a possibility for abuse, but proof of that fact falls short of establishing bad faith on Mr. Moran's part or that he dispensed the drugs other than in the course of his practice of pharmacy. The statutory presumption regarding

       "excessive or inappropriate quantities" contemplates filling a prescription for a patient. Whatever the investigator may have told Mr. Moran about Dr. Bevier, it was only after all the cocaine had been dispensed that the conversation occurred.

       
       

   11. Dispensation of the four Demerol ampules did occur after the investigator had spoken to Mr. Moran, but the evidence was insufficient to show that Mr. Moran was under a duty to disbelieve Dr. Bevier when he said he would use the drug to relieve the pain his dying stepfather was experiencing. No evidence suggests any impropriety on respondents' part in filling the prescriptions Dr. Bevier wrote for Lige Williams, his patient and stepfather, who, Mr. Moran was given to understand, was dying of lung cancer.

RECOMMENDATION

Upon consideration of the foregoing, it is RECOMMENDED:

That petitioner dismiss the administrative complaints filed against respondents.

DONE and ENTERED this 21st day of June, 1984, in Tallahassee, Florida.

ROBERT T. BENTON II

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 21st day of June, 1984.

COPIES FURNISHED:

Bruce D. Lamb, Esq.

Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

W. C. Hutchison, Jr., Esq. Hutchison & Mamele

230 North Park Avenue Sanford, Florida 32771

Fred Roche, Secretary

Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

Wanda Willis, Executive Director Department of Professional Regulation Board of Pharmacy

130 North Monroe Street Tallahassee, Florida 32301

Docket for Case No: 82-003472

Orders for Case No: 82-003472