STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF )

PHARMACY, )

)

Petitioner, )

)

vs. ) CASE NO. 90-5809

)

AHMAD ALLY, as an individual) pharmacist and as owner of ) THE MEDICINE SHOPPE, )

)

Respondent. )

)

RECOMMENDED ORDER

This matter came on for hearing in Miami, Florida, before Robert T. Benton, II, Hearing Officer of the Division of Administrative Hearings, on May 28, 1991. The parties filed proposed recommended orders on June 25, 1991, the date on which all agreed. The attached appendix addresses proposed findings of fact by number.

APPEARANCES

For Petitioner: Michael A. Mone Esquire

Department of Professional Regulation

1940 N. Monroe Street Tallahassee, Florida 32399-0752

For Respondent: Neil F. Garfield, Esquire

Garfield & Associates

3500 North State Road 7, Suite 333 Ft. Lauderdale, Florida 33319

STATEMENT OF THE ISSUE

Whether petitioner should take disciplinary action against respondent for the reasons alleged in the administrative complaint?

PRELIMINARY STATEMENT

By administrative complaint filed April 12, 1989, petitioner alleged that respondent "at all times material . . . a pharmacist . . . and . . . president of American Chemist Shops, Inc., the permittee of The Medicine Shoppe . . . is and has been the prescription department manager of The Medicine Shoppe"; that on "or about November 28, 1988, the Respondent sold to Detective Schuster of the North Miami Police Department approximately six ounces of Tussionex . . . [even though] Schuster did not present the Respondent with a prescription for the Tussionex . . . which contains hydrocodone and is listed in Schedule III of

Chapter 893, Florida Statutes," all in violation of Section 465.016(1)(e) and

1. and 465.023(1)(c), Florida Statutes; and that on "or about December 7, 1988, the Respondent delivered and sold to Detective Schuster approximately sixty Valium without first being presented a valid prescription for the Valium . . . which contains diazepam a controlled substance listed in Schedule IV of Chapter 893, Florida Statutes," in violation of the same statutory provisions; and finally that "[b]etween approximately January 1988 and December 1988, the Respondent dispersed controlled substances pursuant to prescriptions which were forgeries . . . failed to exercise professional judgment . . . to obtain verification of the validity of the prescriptions presented . . . [thereby violating] a requirement of Chapter 893, Florida Statutes" and so of Section 465.016(1)(e), Florida Statutes.

   
   

   FINDINGS OF FACT

   
   

   1. At all pertinent times, respondent has held a Florida pharmacist's license, No. PS0017402, and has been president of American Chemist Shops, Inc., which holds permit No. PH0009600 to operate The Medicine Shoppe, a community pharmacy, at 488 NE 125th Street in North Miami, Florida.

      
      

   2. A second generation pharmacist, Mr. Ally trained in his native (British) Guyana and at the Chelsea School of Pharmacy in London, before qualifying as a pharmacist in England. He also worked at Rand Memorial Hospital in Freeport, Bahama Islands, before his initial licensure in Florida in 1979.

      
      

   3. After three years as a staff pharmacist at one Florida hospital and five and a half years as director of pharmacy at another, he went to work for Mrs. Friedman, a pharmacist's widow, then bought the pharmacy from her. Ever since he started at The Medicine Shoppe, respondent has been director of the pharmacy department.

      
      

   4. Even when Howard Friedmann was alive, Bonita Liston, a woman in her twenties, was a regular customer of The Medicine Shoppe. From time to time a Dr. Murray prescribed pain killers or antibiotics for her. The shop kept a file or card on Ms. Liston as it did on other regular customers.

      
      

   5. Ms. Liston's record reflected the filling of several prescriptions, but none after June 10, 1988, the date respondent's assistant made a note in the file which reads, "North Miami Detectives came in Shoppe, Do not disperse any Rx's." Hearing Officer's Exhibit No. 1.

      
      

   6. Nevertheless, on November 28, 1988, Mr. Ally gave Ms. Liston a brown two-ounce bottle full of Tussionex, a Schedule III "medicinal drug" containing hydrocodone. Coughing, she had arrived without a prescription shortly before the pharmacy closed that day.

      
      

   7. Dr. Murray had prescribed six-ounce supplies of this medicine for her on two occasions in September of 1987, and, respondent testified, she told him she would secure another such prescription the next day, return for four more ounces, and make payment.

      
      

   8. With Ms. Liston at the pharmacy on November 28, 1988, was Jodie Schuster, at the time an undercover policewoman working for the North Miami Police Department. Concealed on her person was a microphone or "body bug" which allowed special agent Jeffrey Michael Portz of the Florida Department of Law Enforcement to monitor conversations in the pharmacy.

   9. On December 7, 1988, respondent's 35th wedding anniversary, Ms. Schuster returned to the pharmacy similarly wired, and Mr. Portz resumed monitoring. She asked for more cough medicine for Ms. Liston, and respondent gave her two ounces of Hycodan, a drug not unlike Tussionex. Respondent's testimony that he did not also give her Valium tablets has been credited. Again no money changed hands, nor was any consideration offered or discussed.

      
      

   10. Taken from the pharmacy in handcuffs, respondent was criminally prosecuted and, on May 22, 1987, sentenced. Among other things, the sentencing judge suspended respondent's pharmacist's license effective that date. Petitioner reinstated the license on January 31, 1991, and renewed it shortly before hearing.

       
       

   11. Before his arrest, respondent and his assistant filled 80 to 120 prescriptions a day. In keeping with legal requirements, physicians prescribing controlled substances report the number assigned them by the federal Drug Enforcement Administration (DEA), by writing it or causing it to be written on the prescription form. Every such number is preceded by two letters, "A" followed by the first letter of the doctor's last name.

       
       

   12. Among the prescriptions for controlled substances filled by respondent or under his supervision at The Medicine Shoppe were some 30 which another pharmacist testified he would not have filled without verification. Two do not have patients' addresses. One prescription filled, Petitioner's Exhibit No. 1A, lacks a legible doctor's name, and has no DEA number. Another gives DEA number AH 224 3119 for a Dr. A. Carlos Casademont. Petitioner's Exhibit No. 6B.

       
       

   13. These irregularities notwithstanding, petitioner did not offer competent evidence to prove that any of the prescriptions were forged or invalid. An expert testified that good practice would have required verification, but was unable to say that respondent had in fact failed to verify the prescriptions. Petitioner did not allege or prove the absence of a written record (apart from the cancelled prescriptions themselves) of controlled substances, or prove the contents of any such records.

       
       

       CONCLUSIONS OF LAW

       
       

   14. Since the Department of Professional Regulation referred respondent's hearing request to the Division of Administrative Hearings, in accordance with Section 120.57(1)(b)3., Florida Statutes (1990 Supp.), "the division has jurisdiction over the formal proceeding." Section 120.57(1)(b)3., Florida Statutes (1990 Supp.).

       
       

   15. Petitioner seeks revocation of respondent's license. License revocation proceedings have been said to be "'penal' in nature." State ex rel. Vining vs. Florida Real Estate Commission, 281 So.2d 487, 491 (Fla. 1973); Kozerowitz vs. Florida Real Estate Commission, 289 So.2d 391 (Fla. 1974); Bach vs. Florida State Board of Dentistry, 378 So.2d 34 (Fla. 1st DCA 1979) (reh. den. 1980). Strict procedural protections apply in disciplinary cases, and the prosecuting agency's burden is to prove its case clearly and convincingly. Ferris vs. Turlington, 510 So.2d 292 (Fla. 1987). See Addington vs. Texas, 441

       U.S. 426 (1979); Ferris vs. Austin, 487 So.2d 1163 (Fla. 5th DCA 1986);

       Anheuser-Busch, Inc. vs. Department of Business Regulation, 393 So.2d 1177 (Fla. 1st DCA 1981); Walker vs. State Board of Optometry, 322 So.2d 612 (Fla. 3rd DCA 1975); Reid vs. Florida Real Estate Commission, 188 So.2d 846, 851 (Fla. 2nd DCA 1966). A licensee's breach of duty justifies revocation only if the duty has a

       "substantial basis," Bowling vs. Department of Insurance, 394 So.2d 165, 173 (Fla. 1st DCA 1981) in the evidence, unless applicable statutes and rules create a clear duty, which the evidence shows has been breached.

       
       

   16. In appropriate cases, the Board of Pharmacy is authorized to "enter an order imposing one or more of the following penalties:

       
       

       1. Refusal to certify to the department an application for licensure.

       2. Revocation or suspension of a license.

       3. Imposition of an administrative fine not to exceed $1,000 for each count or separate offense.

       4. Issuance of a reprimand.

       5. Placement of the pharmacist on probation for a period of time and subject to such con- ditions as the board may specify, including requiring the pharmacist to submit to treatment, to attend continuing education courses, to submit to reexamination, or to work under the supervision of another pharmacist.

          
          

          Section 465.016(2), Florida Statutes (1989). As grounds for disciplinary action against respondent's license as a pharmacist, petitioner sought to prove respondent guilty of the following:

          
          

          (e) Violating any of the requirements of this chapter; or if licensed as a practitioner in this or any other state, violating any of the requirements of their respective practice act

          or violating chapter 499; 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.

          . . .

          (i) Compounding, dispensing, or distributing a legend drug, including any controlled sub- stance, other than in the course of the pro- fessional practice of pharmacy. For purposes

          of this paragraph, it shall be legally presumed that the compounding, dispensing, or distri- buting of legend drugs in excessive or inappro- priate 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 (1989). Section 415.015(2), Florida Statutes (1989) makes it "unlawful for any person: . . . (c) To sell or dispense drugs as defined in s. 465.003(7) without first being furnished with a prescription." Under the statute, "'drugs' means those substances or preparations commonly known as 'prescription' or 'legend' drugs which are required by federal or state law to be dispensed only on a prescription, . . .

          ." Section 465.003(7), Florida Statutes (1989).

          
          

   17. To the same effect, Section 465.023, Florida Statutes (1989), authorizes the "board . . . [to] revoke or suspend the permit of any pharmacy permittee, and . . . fine, place on probation, or otherwise discipline any

       pharmacy permittee who has: . . . (c) Violated any of the requirements of this chapter or any of the rules of the Board of Pharmacy; of chapter 499, known as the "Florida Drug and Cosmetic Act"; of 21 U.S.C. ss. 301-392, known as the "Federal Food, Drug, and Cosmetic Act"; of 21 U.S.C. ss. 821 et seq., known as the Federal Drug Abuse Act; or of chapter 893." (Footnotes omitted.) In subsection two, the statute further provides that "If a pharmacy permit is revoked or suspended, the . . . period of such suspension shall be prescribed by the Board of Pharmacy, but in no case shall it exceed 1 year." Section 465.023, Florida Statutes (1989).

       
       

   18. The proof showed that a Dr. Casademont's DEA number beginning with the letters AH should have put respondent on notice that something was amiss, whether or not he noticed the discrepancy in fact. But petitioner did not allege or prove any violation of a rule adopting "standards of practice relating to the practice of pharmacy." Section 465.0155, Florida Statutes (1989). Petitioner also failed to demonstrate noncompliance with Section 893.04, Florida Statutes (1989), which provides:

1. A pharmacist, in good faith and in the course of professional practice only, may dis- pense controlled substances upon a written or oral prescription of a practitioner, under the following conditions:

   1. Oral prescriptions must be promptly re- duced to writing by the pharmacist.

   2. The written prescription must be dated and signed by the prescribing practitioner on the day when issued.

   3. There shall appear on the face of the prescription or written record thereof for the controlled substance the following information:

1. The full name and address of the person

   for whom, or the owner of the animal for which, the controlled substance is dispensed.

2. The full name and address of the pre- scribing practitioner and his federal con- trolled substance registry number shall be printed thereon.

3. If the prescription is for an animal, the species of animal for which the controlled substance is prescribed.

4. The name of the controlled substance prescribed and the strength, quantity, and directions for use thereof.

5. The number of the prescription, as re- corded in the prescription files of the pharmacy in which it is filled.

6. The initials of the pharmacist filling the prescription and the date filled. (Emphasis supplied.)

While the evidence was clear that not all the required information appeared on all of the cancelled prescriptions, the proof did not exclude the existence of other adequate "written record thereof." But the evidence did establish clearly and convincingly that respondent dispensed legend drugs at The Medicine Shoppe

for which no prescription was presented, in violation of Sections 465.016(2)(e) and 465.023, Florida Statutes (1989), including Tussionex, as alleged in the administrative complaint.

RECOMMENDATION

It is, accordingly recommended:

1. That petitioner suspend respondent's pharmacist's license for two (2) years, with credit for any suspension on account of delivery of Tussionex to Bonita Liston already accomplished.

   
   

2. That petitioner suspend respondent's pharmacy permit for one (1) year, with credit for any suspension on account of delivery of Tussionex to Bonita Liston already accomplished.

RECOMMENDED this 27th day of August, 1991, in Tallahassee, Florida.

ROBERT T. BENTON, II

Hearing Officer

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, FL 32399-1550

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 27th day of August, 1991.

APPENDIX TO RECOMMENDED ORDER, CASE NO. 90-5809

With respect to petitioner's proposed finding of fact No. 1, the testimony was that the drug delivered to Ms. Schuster on December 7, 1988, resembled Tussionex but was not Tussionex.

Petitioner's proposed finding of fact No. 2 is rejected as against the weight of the evidence.

With respect to petitioner's proposed finding of fact No. 3, the evidence showed that certain prescriptions lacked the patient's address, the physician's DEA number or other detail, but petitioner's expert said it was acceptable practice to fill such prescriptions, if verified.

Petitioner's proposed finding of fact No. 4 has been accepted at least as regards the Casademont prescription with DEA No. AH 224 3119.

Petitioner's proposed finding of fact No. 5 is really a proposed conclusion of law.

Respondent's proposed finding of fact No. 3, including subparts, has been adopted in substance, insofar as material, and to the extent reported in the findings of fact.

Respondent's proposed findings of fact Nos. 4.1 through 4.4 are rejected as contrary to the weight of the evidence.

Respondent's proposed findings of fact Nos. 4.5 through 4.9 and No. 5, including subparts, have been adopted, in substance, insofar as material.

COPIES FURNISHED:

John Taylor, Executive Director Board of Pharmacy

Department of Professional Regulation

1940 N. Monroe Street Tallahassee, FL 32399-0792

Jack McRay, General Counsel Department of Professional

Regulation

1940 N. Monroe Street Tallahassee, FL 32399-0792

Michael A. Mone, Esquire Department of Professional

Regulation

1940 N. Monroe Street Tallahassee, FL 32399-0752

Neil F. Garfield, Esquire Garfield & Associates

3500 North State Road 7, Suite 333 Ft. Lauderdale, FL 33319

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS:

ALL PARTIES HAVE THE RIGHT TO SUBMIT WRITTEN EXCEPTIONS TO THIS RECOMMENDED ORDER. ALL AGENCIES ALLOW EACH PARTY AT LEAST 10 DAYS IN WHICH TO SUBMIT WRITTEN EXCEPTIONS. YOU SHOULD CONTACT THE AGENCY THAT WILL ISSUE THE FINAL ORDER IN THIS CASE CONCERNING AGENCY RULES ON THE DEADLINE FOR FILING EXCEPTIONS TO THIS RECOMMENDED ORDER. ANY EXCEPTIONS TO THIS RECOMMENDED ORDER SHOULD BE FILED WITH THE AGENCY THAT WILL ISSUE THE FINAL ORDER IN THIS CASE.

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AGENCY FINAL ORDER

=================================================================

STATE OF FLORIDA

DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF PHARMACY

DEPARTMENT OF PROFESSIONAL REGULATION,

Petitioner,

vs. CASE NO. 90-5809

AHMAD ALLY,

Respondent.

/

FINAL ORDER

The Florida Board of Pharmacy of the Department of Professional Regulations on November 14, 1991 at a regular scheduled meeting held in Miami, Florida, after reviewing the Recommended Order entered in this case by Robert T. Benton, II, Hearing Officer, Division of Administrative Hearings, on August 27, 1991, and after reviewing the exceptions filed in this cause by Petitioner, and being otherwise fully advised in the premises, hereby REJECTS the Exceptions filed by Respondent, however, the Board determines that the Hearing Officer's recommended disci- pline i.e., two (2) years suspension of the Respondent's pharmacist's license and an additional one (1) year suspension of the pharmacy permit is not warranted. It is the Board's position that in view of the type of medication at issue in the instant cause and its limited potential for addiction that the improper dispensing of the same by Respondent in the instant cause does not warrant any additional discipline other than that already imposed on Respondent's pharmacist's license by the Circuit Court. As a result therefore, the Board accepts the Proposed Finding of Fact and Conclusions of Law of the Hearing Officer. However, it modifies the Recommended Penalty to delete the suspension of Respondent's permit and to limit the suspension of Respondent's pharmacy license to the same terms and conditions imposed by the Circuit Court and to run concurrent with the Circuit Court's Order. Said Recommended Order is hereby declared to be and this Order becomes the Final Order of the Board of Pharmacy.

DONE and ORDERED this 20th day of December , 1991, by the Florida Board of Pharmacy.

cc: Niel F. Garfield, Esquire Michael A. Mone', Esquire

JOHN TAYLOR EXECUTIVE DIRECTOR

Docket for Case No: 90-005809

Orders for Case No: 90-005809