STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )

)

Petitioner, )

)

vs. ) CASE NO. 82-1729

) FEDERGO DISCOUNT CENTER and ) EDDY PORTILLO and EDITH )

PORTILLO, Owners/Officers, )

)

Respondents. )

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, SHARYN L. SMITH, held a formal hearing in this case on March 31, 1983, in Miami, Florida. The following appearances were entered:

APPEARANCES

For Petitioner: W. Douglas Moody, Jr., Esquire

119 North Monroe Street Post Office Drawer 11007 Tallahassee, Florida 32302

For Respondents: Eddy and Edith Portillo

1881 79th Street Causeway Miami Beach, Florida 33143

ISSUE

The issue presented at the final hearing was whether the Respondents' Eddy and Edith Portillo pharmacy permit should be revoked or suspended for the acts of a licensed pharmacist hired by the Respondents who engaged in unprofessional and bad faith dispensing of methaqualone as alleged in the Administrative Complaint filed May 26, 1982.

John McDonough, a Department medical investigator, John Statnik, a community pharmacist and licensed pharmacist, and Sidney Simkovitz, a retired pharmacist, testified for the Petitioner.

Petitioner's Exhibits 1-3 were offered and admitted into evidence. The Respondent Eddy Portillo testified on his own behalf and Respondents' Exhibit 1 was admitted as a late-filed exhibit.

A proposed Recommended Order has been submitted by the Petitioner. To the extent that the proposed findings submitted by Petitioner are not reflected in this Order, they were rejected as being either not supported by the weight of admissible evidence or as being irrelevant to the issues determined here.

FINDINGS OF FACT

1. The Respondents Eddy and Edith Portillo hold pharmacy permit number 7276 for Federgo Discount Center, which is located at 1881 79th Street Causeway, North Bay Village, Miami Beach, Florida.

   
   

2. Federgo Discount Center is a discount dry goods facility housed in a building of approximately 3,000 square feet. A small portion of the store is occupied by a pharmacy.

   
   

3. The Respondent Eddy Portillo is the manager of the entire facility. Since Portillo was not a licensed pharmacist, he hired Michael Interess, a state licensed pharmacist, to operate the pharmacy portion of the store.

   
   

4. Pursuant to a "contract work agreement" executed between the Respondent Eddy Portillo and Interess, net profits from the operation of the pharmacy were divided 40 percent to the pharmacist and 60 percent to the store following the deduction of certain delineated items from gross profits. In effect, the pharmacist's wages were based on his success in operating the pharmacy since he was not paid any guaranteed wage.

   
   

5. A drug diversion audit conducted by the Petitioner established that the following amounts of methaqualone were dispensed by the pharmacy:

   
   

   1. November 1, 1981 through February 15, 1982; 56,386 Methaqualone dispensed.

   2. June 1, 1980 through February 15, 1982; 251,230 Methaqualone dispensed.

      
      

6. When compared to all other Schedule II drugs dispensed by the pharmacy, the percentage of methaqualone dispensed during the audit period was 76.96 percent. No evidence was presented concerning the amount of methaqualone as a percentage of total prescription sales.

   
   

7. Based on a seven-day week, approximately 14 methaqualone prescriptions were filled every day of the audit period by the pharmacy.

   
   

8. As manager and cashier of the center, the Respondent Eddy Portillo spent a considerable amount of time within the store. The Respondent Portillo received a daily log of all drug sales which indicated the amount of sales in order to compensate Interess, the pharmacist. Although the Respondent Eddy Portillo knew the pharmacy was filling methaqualone prescriptions, he believed the percentage of methaqualone dispensed to be reasonable in relation to total prescription sales. The pharmacy received a large number of methaqualone prescriptions due to its geographical proximity to physicians who apparently frequently prescribed this drug.

   
   

   CONCLUSIONS OF LAW

   
   

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

   
   

10. The Respondents Eddy and Edith Portillo are charged with violating Sections 465.023(1)(c), 465.016(1)(i) and 893.04(1), Florida Statutes (1981). 1/

11. Section 465.023(1)(c), Florida Statutes authorizes the department or board to revoke or suspend the permit of any person was has, inter alia:

    
    

    Violated any of the requirements of this chapter or any of the rules of the Board of Pharmacy; of chapter 500, known as the "Florida Food, Drug, and Cosmetic Law"; or of chapter 893; . . .

    
    

12. Section 465.016(1)(i), Florida Statutes, empowers the board to take disciplinary action against a pharmacist found to have been, inter alia:

    
    

    Compounding, dispensing, or distributing a legend drug, including any controlled substance, other than in the course of professional practice of pharmacy. For purposes of this paragraph, 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.

    
    

13. Pursuant to Section 893.04(1), Florida Statutes, a pharmacist must act in good faith and in the course of his professional practice in dispensing controlled substances.

    
    

14. The thrust of the Department's position in this case is that the Respondents' permit is subject to revocation based on the unlawful actions of the pharmacist who was employed during the period in question. In effect, the Respondents are charged with failing to adequately supervise the pharmacist to ensure that he was not excessively dispensing controlled substances.

    
    

15. Initially, it must be determined whether any statute places a duty on a permit holder to supervise the professional activities of a licensed pharmacist. Section 465.018, Florida Statutes, places three duties on a permit holder at the time of issuance of a permit, including: (1) designating a prescription department manager, who must be a licensed pharmacist, who is responsible for maintaining all drug records, (2) providing for the security of the prescription department, and (3) following such other rules as they relate to the practice of the profession of pharmacy. 2/ Section 465.023(1)(c), Florida Statutes, authorizes disciplinary proceedings against a permit holder for violating any of the requirements of Chapter 465. Thus, the failure to comply with Section 465.018 following issuance of a permit constitutes grounds for discipline pursuant to Section 465.023(1)(c), Florida Statutes.

    
    

16. The Respondent is clearly not charged with failing to designate a licensed pharmacist as a prescription manager who is responsible for maintaining drug records. Neither is he charged with failing to provide for the security of the prescription department through negligence or otherwise. It is not alleged in the Administrative Complaint, nor was it stated at any subsequent time, that the Respondent violated any "rules" regulating the practice of pharmacy or precisely what such rules were.

17. Instead, it is apparently the position of the Department that the Respondent's duty to supervise the professional judgment of a licensed pharmacist is a result of general principles of agency, rather than any specific duty imposed by law. The Department asserts that vicarious liability exists as to the principal, in this case the permit holder, in a situation where an agent's improper or criminal acts were committed in the course of the agent's employment.

    
    

18. In Alles v. Department of Professional Regulation, 423 So.2d 624 (Fla. 5th DCA 1982), the court found that a licensed contractor who acted as a qualifying agent for an otherwise unlicensed construction company had a statutorily imposed duty to supervise the construction undertaken by the company which he qualified. The supervisory duty in Alles was based on the statute in question, Section 489.119, Florida Statutes, which evidenced a legislative intent that qualifying agents be required to supervise a project entered into under the name of and by use of the contractor's license. The power to discipline in Alles was not based on concepts of agency, but rather on a duty imposed by statute. Additionally, a practical problem presented in Alles was that the only licensed individual was the qualifying agent. In the instant case, the statutory scheme set forth in Chapters 465 and 893, Florida Statutes, places well defined duties on licensed pharmacists which require the careful exercise of sound professional judgment. In certain instances, a licensed pharmacist may be required by law to exercise professional discretion by refusing to dispense, notwithstanding the existence of a prescription written by a duly authorized physician which complies with all procedural statutory requirements. To take this one step further by requiring a nonprofessional permit holder to supervise the activities of a licensed pharmacist which involve the exercise of professional judgment and discretion is a requirement which should not be inferred in the absence of clear and unequivocal legislative authority. 3/ Had the licensed pharmacist failed to adequately maintain records, or had he otherwise compromised the security of the drugs in the prescription department, a different result could be indicated. However, in this case, the allegations concerning inadequate record-keeping which were" contained in Count II of the Administrative complaint were not pursued by the Petitioner.

    
    

19. Moreover, assuming, arguendo, that the Respondents as permit holder had a duty imposed by statute to supervise the dispensing of prescription drugs by a licensed pharmacist, the Petitioner failed to carry its burden of proving that the Respondents knew or should have known that the licensed pharmacist was excessively dispensing Quaaludes. While the Respondent Eddy Portillo was present on the premises as store manager, he was not involved in the operation of the pharmacy. Although the Respondent Portillo knew that methaqualone was being dispensed, he believed it to be a reasonable portion of total sales. The Respondent Portillo received daily figures which demonstrated total sales, but did not receive individual breakdowns of prescriptions by drug or class of drug. Additionally, no evidence is contained in the record that the Respondent Edith Portillo was involved in operating either the center or the pharmacy.

    
    

20. Finally, it should be noted that nothing in the law requires a community pharmacy permit holder to be a licensed pharmacist, although both experts who testified for the Petitioner were licensed pharmacists who were also community pharmacy permit holders. It is, therefore, reasonable to assume that the steps which were taken by the experts to supervise the licensed pharmacists which they hired for their community pharmacies were based in large part on their professional knowledge and personal experiences as licensed pharmacists. 4/ To require the same or similar standard of a non-professional permit holder

who is not required by law to be a licensed pharmacist could lead to a situation where non-professional permit holders could be held to a standard that only licensed professionals could reasonably be expected to meet.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered by the Board of Pharmacy

dismissing the Administrative Complaint against the Respondents.

DONE and ORDERED this 17th day of June, 1983, in Tallahassee, Florida.

SHARYN L. SMITH, 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 17th day of June, 1983.

ENDNOTES

1/ The Petitioner has conceded that no proof was presented at hearing on Count II of the Administrative Complaint.

2/ The "rules" referred to in the statute are unidentified.

3/ Compare Bach v. Board of Dentistry, 378 So.2d 34 (Fla. 1st DCA 1979) which discussed the supervisory duties of a dentist toward a dental hygienist required by Sections 466.09(8) and (9), Florida Statutes.

4/ One expert recognized this by stating that his procedures for checking on doctors who write prescriptions for certain drugs such as Percodan or codeine, were based on his experience of having served on the Board. See Transcript at 71.

COPIES FURNISHED:

W. Douglas Moody, Jr., Esquire

119 North Monroe Street Post Office Drawer 11007 Tallahassee, Florida 32302

Eddy and Edith Portillo 1881 79th Street Causeway Miami Beach, Florida 33143

Wanda Willis, Executive Director Florida Board of Pharmacy

Old Courthouse Square Building

130 North Monroe Street Tallahassee, Florida 32301

Frederick Roche, Secretary Department of Professional

Regulation

130 North Monroe Street Tallahassee, Florida 32301

Docket for Case No: 82-001729

Orders for Case No: 82-001729