STATE OF FLORIDA DIVISION OF ADMINISTRATIVE HEARINGS

FLORIDA BOARD OF PHARMACY, )

)

Petitioner, )

)

vs. ) CASE NO. 76-401

)

CORAL WAY PHARMACY, INC., )

and RAUL PRADA, )

)

Respondents. )

)

RECOMMENDED ORDER

A hearing was held in the above-styled matter, after due notice to the parties, at Miami, Florida, on March 31, 1976, before the undersigned Hearing Officer.

APPEARANCES

For Petitioner: Stanley P. Kaplan, Esquire

404 Biscayne Building Miami, Florida

For Respondent: Emilio De La Cal, Esquire

301 Almeria Avenue Coral Gables, Florida

ISSUE PRESENTED

Whether Respondent's permit to operate a pharmacy should be suspended or revoked for alleged violations of Sections 465.18(1)(b), 465.18(2)(b), 465.22(1)(c), Florida Statutes, and Rule 21S-1.14, Florida Administrative Code.

At the commencement of the hearing, counsel for Respondent moved to continue the proceedings in order that Detective Robert Delgado could be deposed. There being no showing that a timely notice of taking deposition had been issued or a subpoena requested therefor, the Motion was denied.

FINDINGS OF FACT

1. While on a routine inspection of a pharmacy, Vernon K. Bell, investigator for the Petitioner, obtained a prescription issued by Dr. Rafael Cardella, Miami, Florida for 30 tablets of cardilate, 10 miligrams, that had not been picked up at the pharmacy by the person designated in the prescription. Bell secured this prescription for use in investigation of other pharmacies. Cardilate is a vasodilator that is used by cardiac patients with angina pectoris as a maintenance medication to prevent one from having angina pectoris attacks. It is a product made by Burroughs Wellcome Pharmaceutical House and consists of scored white tablets. The tablets act similarly to nitroglycerin medication and

   are dispensed only upon prescription (Testimony of Bell, Petitioner's Exhibit 1.)

   
   

2. Acting upon a prior complaint against Respondent's pharmacy, Bell conducted an investigation into its practices with regard to dispensing prescription medicine. At 8:50 P.M., January 14, 1976, he provided the cardilate prescription to officer Robert Delgado, intelligence investigator, Dade County Public Safety Department, who entered Respondent's pharmacy to see if the prescription would be filled during a period when it was assumed that the registered pharmacist was not on duty. He handed the prescription to Concepcion Prada and asked that it be filled. She went to the prescription area of the pharmacy through an unlocked door and in five or ten minutes came back with a bottle of pills labeled "cardilate 10". Delgado had been unable to observe who had filled the prescription. Mrs. Prada told him that she only had ten tablets, but that he could come the next day for the remainder of the prescription of thirty tablets. He paid her $1.50 for the medicine, left the pharmacy, and turned the bottle over to Bell who was outside (Testimony of Delgado, Petitioner's Exhibit 2.)

   
   

3. Bell thereupon entered the Pharmacy, identified himself and asked Mrs. Prada if there was a pharmacist on duty. She responded in the negative. Bell then proceeded through an open door into the prescription department and picked up the prescription that he had given to Delgado. He then asked Mrs. Prada who had filled the prescription and she informed him that she had done so. He then told her that he would be issuing a violation complaint in the matter. Mrs. Prada had been a registered pharmacist in Cuba, but had informed Bell on a prior occasion that she was not a registered pharmacist in Florida. At the time of the incident described above, she told him that she was going to attend classes at Loyola School. This school prepares individuals who desire to obtain qualifications for taking examinations for registration before the Board of Pharmacy. Circumstances surrounding the statements made by Mrs. Prada to Bell establish that they were made voluntarily (Testimony of Bell.)

   
   

4. It is possible that cardilate could save a life under certain circumstances. At the time of the dispensing of the medicine in question, three or four pharmacies within 10 blocks of Respondent's pharmacy were open (Testimony of Bell.)

   
   

   CONCLUSIONS OF LAW

   
   

5. Petitioner seeks to take adverse action concerning Respondent's permit to operate a pharmacy based on alleged violations of Sections 465.18(1)(b), 465.18(2)(b), 465.22(1)(c), Florida Statutes, and Rule 21S-1.14, Florida Administrative Code, which read pertinently as follow:

   
   

   "465.18 Violations and penalties.-

   1. It is unlawful for any person to own, operate, maintain, open, establish, conduct, or have charge of, either alone or with another person or persons, a pharmacy:

      * * *

      (b) In which a person not licensed as a pharmacist in this state, or not registered as an intern in this state, or an intern who is not acting under the direct and immediate personal supervision of a licensed pharmacist, fills, compounds, or dis- penses any prescription, or dispenses medicinal

      drugs.

      * * *

   2. It is unlawful for any person:

      * * *

      1. To fill, compound, or dispense prescriptions or to dispense medicinal drugs when such person is not licensed as a pharmacist in this state, is not

         registered as an intern in this state, or is an intern not acting under the direct and immediate personal supervision of a licensed pharmacist.

         
         

         465.22 Authority to revoke or suspend pharmacy permits.-

         (1) The Board of Pharmacy may revoke or suspend the permit of any pharmacy after giving reasonable notice and an opportunity to be heard to any permittee who shall have:

         * * *

      2. Violated any of the requirements of this chapter or any of the rules and regulations of the Board of Pharmacy...

      
      

      21S-1.14 Prescription Department; Padlock; Sign: "Prescription Department Closed". If a community pharmacy is open for business and a Florida reg- istered pharmacist is not present and on duty, the prescription department shall be considered closed;... provided that all times when the prescription department is closed, either

      because of the absence of a Florida registered pharmacist or for any other reason, the said prescription department shall be separated from the remainder of the community pharmacy by part- ition or other means of enclosure, and said enclosure shall be locked or padlocked so as to prevent the entry into said department by persons not licensed to practice pharmacy in the State of Florida, and at such times no person other than a person licensed to practice pharmacy in Florida shall enter or be permitted to enter the prescrip-

      tion department of any community pharmacy provided, further, that all such times only a Florida regis- tered pharmacist shall have the means to gain access to the said prescription department ...

      
      

6. As to Count I - In this Count, Petitioner alleges that Respondent permitted the unlawful practice of pharmacy by the fact that a person who is not licensed or registered as a pharmacist or as a pharmacy intern in Florida, Concepcion Prada (sic), filled and dispensed a prescription legend drug, 10 Cardilate, 10 milligram tablets to R. Delgado on January 14, 1976. Although Petitioner did not submit evidence concerning the issuance of a permit to Respondent nor establish specifically that Mrs. Prada was not a registered Florida pharmacist or pharmacy intern, the testimony of Bell as to his conversation with her concerning her status is considered sufficient to show that she was not a person authorized under Section 465.18(1)(b) and 2(b), to dispense drugs. By her own admission, Mrs. Prada dispensed prescription drugs to Delgado. Although the prescription utilized in this case was originally

   obtained under somewhat unusual circumstances, it was authentic and sufficient under the definition of the term "prescription", as set forth in Section 465.03(1).

   
   

7. The evidence consisting of the labeled bottle of medicine further supports the fact that the tablets dispensed by Mrs. Prada were, in fact, those required by the prescription, i.e., Cardilate 10 milligram tablets, in the absence of evidence to the contrary. It is thus concluded that Petitioner is authorized to take adverse action concerning the permit of Respondent under the authority of Section 465.22(1)(c) for a violation of the requirements of Chapter 465, to wit: Section 465.18(1)(b). It is considered that a violation of 465.18(2)(b) is inappropriate because that subsection is directed against the individual who unlawfully dispenses drugs and does not relate to the pharmacy itself.

   
   

8. As to Count II - This count alleges that Respondent violated Rule 21S-

   1.14 by permitting the prescription department to remain unlocked at a time when a licensed pharmacist was not present and on duty at the pharmacy. The evidence establishes that the door to the prescription area of Respondent's pharmacy was not locked at the time of the incident that occurred on January 14, 1976, and that a licensed pharmacist was not present on duty at the time. This constitutes a violation of the cited rule and authorizes adverse action as to Respondent's permit under the authority of Section 465.22(1)(c) as a violation of a rule of the Board of Pharmacy.

   
   

9. Respondent contends that disciplinary action should not be taken in the matter due to the fact that Mrs. Prada reasonably could have supposed that a person's life had been in danger when she was given the prescription and therefore was acting in a humane manner in filling the same. However, nothing had been said by officer Delgado which could have led her to this belief and it was established that several pharmacies were open in the immediate area. Accordingly, this is not considered as a mitigating aspect. On the other hand, Mrs. Prada had been a registered pharmacist in Cuba and was by no means unfamiliar with the dispensing of prescription drugs. Therefore, it is highly unlikely that her filling of the prescription in question could have been inaccurate or could have posed a serious danger to the public. Nevertheless, it was in violation of the law and warrants appropriate disciplinary action.

   
   

10. Taking into consideration the entire circumstances, it is determined that suspension or revocation of Respondent's permit is not warranted, but that a civil penalty of $500.00 should be imposed in lieu thereof under the authority of Section 465.101(3).

RECOMMENDATION

That a civil penalty in the sum of $500.00 be imposed against Respondent under the authority of Section 465.101(3), Florida Statutes, for violation of Section 465.18(1)(b), Florida Statutes, and Rule 21S-1.14, Florida Administrative Code.

DONE and ENTERED this 19th day of April, 1976, in Tallahassee, Florida.

THOMAS C. OLDHAM

Hearing Officer

Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304

Filed with the Clerk of the Division of Administrative Hearings this 19th day of April, 1976.

COPIES FURNISHED:

Michael Schwartz, Esquire

201 Ellis Building

1311 Executive Center Drive Tallahassee, Florida 32301

Stanley P. Kaplan, Esquire

404 Biscayne Building Miami, Florida

Guillermo F. Mascaro, Esquire

301 Almeria, Suite 3

Coral Gables, Florida 33134

Emilio De La Cal, Esquire

301 Almeria Avenue Coral Gables, Florida

Docket for Case No: 76-000401

Orders for Case No: 76-000401