STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )

)

Petitioner, )

)

vs. ) CASE NO. 84-3732

)

ADDY CORPORATION, d/b/a )

A & C PHARMACY, #2 )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a hearing was held in this cause on July 26, 1985, in Miami Florida before Diane A. Grubbs a hearing officer with the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Bruce Douglas Lamb, Esquire

Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

For Respondent: Kent Harrison Robbins, Esquire

370 Minorca Avenue

Coral Gables, Florida 33134 ISSUE

Whether respondent is guilty of the charges set forth in the Administrative Complaint and if so whether a penalty should be imposed.

BACKGROUND

On September 21, 1984, petitioner filed an Administrative Complaint against the respondent. Count I of the complaint charged respondent with failing to maintain complete and accurate records of drugs dispensed, in violation of section 893.07(1)(b) and thereby section 465.023(1)(c). Count II alleged that on May 10, 1984, Mrs. Rodriguez, the owner of the pharmacy who is not a pharmacist, was in the prescription department when the pharmacist was not on the premises in violation of Rule 215-1.14, Florida Administrative Coded and thereby Section 465.023(1)(c), Florida Statutes. Count III charged respondent with violating Section 465.015(2)(c), Florida Statutes. Count IV of the complaint alleged that respondent violated Rule 215-1.24, Florida Administrative Code, which requires that the prescription department of an establishment be open at least 40 hours a week and 60 percent of the total hours the establishment is open, and thereby violated Section 465.023(1)(c), Florida Statutes.

October 19, 1984, respondent requested a formal hearing on the charges, and the matter was referred to the Division of Administrative Hearings for further proceedings. At the hearings the petitioner dismissed Count III of the complaint and amended Count I, paragraph 5, of the complaint by deleting "Phenergan Ex with Codeine" and "Phentermine 30 mg." from the list of drugs.

The parties stipulated to certain facts including the facts alleged in Count Two, paragraphs 8-13, and Count IV, paragraphs 22-24.

Petitioner presented the testimony of Providence Padrick, Edward Bludworth, Georgina Jorge, Carlos Alfaras Olga Garcia and Ofelia Perez. In addition, Petitioner's exhibits one through five were admitted in evidence. The Respondent presented the testimony of Ada Rodriguez. Respondent's exhibit number two was received into evidence.

Both parties submitted proposed findings of fact and conclusions of law, and a ruling on each proposed finding of fact has been made in the appendix to this order.

FINDINGS OF FACT

1. Respondent is, and has been at all times material to this proceeding, a community pharmacy in the State of Florida, having been issued permit number 0008482. Respondent's last known address is A & C Pharmacy #2, 1053 Washington Avenue, Miami Beach, Florida 33139.

   
   

2. On May 29, 1984, and May 30, 1984, an audit was conducted at respondent's pharmacy by investigators for the Department of Regulation.

   
   

3. The audit covered the period from March 15 1984, the date the permit was first issued and the business first opened, to May 29, 1984.

   
   

4. The audit revealed that the pharmacy was unable to produce records to account for shortages in the following controlled substances, 1/ as defined in Chapter 893, Florida Statutes, and the evidence revealed the shortages to be in the following amounts:

   
   

   DRUG SHORTAGE

   
   

   Librium 5 mg. 62 capsules

   Darvon Compound 65 120 capsules

   Tenuate 75 mg. 130 tablets

   Valium 5 mg. 55 tablets

   Valium 10 mg. 8 tablets

   
   

5. Librium's generic name is chlordiazepoxide, Darvon Compound 65 contains propoxyphene, Tenuate's generic name is diethylpropion, and Valium's generic name is diazepam.

   
   

6. Section 893.07(1)(b), Florida Statutes, requires that every person engaged in dispensing controlled substances maintain "on a current basis a complete and accurate record of each substance manufactured, received, sold, delivered, or otherwise disposed of by him . . ." The audit revealed that the respondent did not have records that showed the disposition of the controlled substances listed above.

7. The records of respondent were in disarray and, to some extent, were mixed with the records of a related pharmacy, A & C Pharmacy #1, located on Flagler Street. Controlled substances were often ordered at the same time for both pharmacies and, on occasion, drugs ordered by one store were delivered to the other. Indeed, due to the poor record keeping, there was some confusion concerning the amount of Tenuate received by the respondent and, accordingly, the amount of the shortage. It is undisputed that respondent received 200 tablets of diethylpropion or Tenuate, on April 9, 1984. On May 10, 1984, an additional 100 tablets of diethylpropion were ordered. The invoice revealed that these tablets were ordered by the A & C Pharmacy on Flagler Street. However, Mrs. Rodriguez provided the invoice to the auditors as part of respondent's records. She also told the auditors that 100 tablets of Tenuate had been transferred from the Flagler Street pharmacy to the respondent due to orders being mixed-up and drugs ordered by one store being delivered to the other. The auditors therefore determined that respondent and received 400 Tenuate tablets: 200 on April 9th, 100 on May 10th, and, an additional 100 transferred from the Flagler pharmacy. There were 170 tablets in respondent's inventory, and no records of any sale. Thus, the auditors determined that there was a shortage of 230 tablets. However, from the evidence presented at the hearing, it appears that the 100 tablets that Mrs. Rodriguez mentioned were the same 100 tablets shown on the invoice dated May 10, 1984. Ms. Jorge's testimony linked the tablets that were transferred to an invoice that had the Flagler pharmacy's address (T-73), and Mr. Bludworth's testimony established that the only records showing purchases were the invoices of April 9 and May 10, 1984.

   (T-34) Thus, the shortage of Tenuate was 130 tablets rather than 230 tablets.

   
   

8. At the time of the audit some of respondent's records, the prescriptions filled, had been sent to Luis Cruz, a Medicaid preparer. However, there was no evidence that any of the prescriptions that had been sent to Luis Cruz were for the controlled substances audited.

   
   

9. The evidence establishes that respondent has failed to maintain, on a current basis, a complete and accurate record of each substance manufactured received sold, delivered or otherwise disposed of by respondent.

   
   

10. On May 10, 1984, an inspection of Respondent's pharmacy was conducted by an investigator for the Department of Professional Regulation.

    
    

11. At the time of the inspection, Ada Rodriguez, the owner of A & C Pharmacy was in the prescription department.

    
    

12. Ada Rodriguez is not a licensed pharmacist in the State of Florida.

    
    

13. The pharmacist on duty was not present when Ada Rodriguez was in the prescription department.

    
    

14. There was no pharmacist on the premises at the time the inspection began, and the prescription department was not locked.

    
    

15. No activity was observed by the investigator which would be consistent with an unlicensed pharmacist dispensing drugs.

    
    

16. When the inspection was conducted, the business hours for the store where respondent's pharmacy is located were 8:30 a.m. to 5:00 p.m., Monday through Friday, and 9:30 a.m. to 3:30 p.m. on Saturday.

17. When the inspection was conducted, the prescription department hours were from 9:00 a.m. to 3:00 p.m., Monday through Friday, thus the prescription department was open a total of thirty (30) hours a week.

    
    

18. Rule 215-1.14, Florida Administrative Code, provides in part as follows:

    
    

    [A]t all times when the prescription depart- ment is closed, either because of the absence of a . . . pharmacist or for any other reason, said prescription department 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 prescription department. . . .

    
    

19. Rule 215-1.24 provides, in part, as follows:

    
    

    1. Any person who receives a community pharmacy permit pursuant to Section 465.018, Florida Statutes, and commences to operate such a establishment shall, for the benefit of the public health and welfare, keep the prescription department of the establishment open for a minimum of forty (40) hours per

       week and sixty (60 percent) percent of the total hours the establishment is open each day. . . .

       
       

20. Since Mrs. Rodriguez has been informed by the investigators of the restricted access requirement for the prescription department, she has not gone into the prescription department except when the licensed pharmacist has been present.

    
    

21. Upon being informed by the investigators of the minimum-hour requirements, the respondent expanded the working hours of the licensed pharmacist in order to increase the number of open hours of the prescription department in order to meet the provisions of Rule 215-1.24.

    
    

22. The Respondent's pharmacy meets the needs of the predominantly Spanish-speaking neighborhood by providing pharmacy services with a Spanish- speaking pharmacist.

    
    

    CONCLUSIONS OF LAW

    
    

23. The Division of Administrative Hearings has jurisdiction over the subject matter of and the parties to this proceeding. Section 120.57(1), Florida Statutes. The Department of Professional Regulation and the Board of Pharmacy have authority to discipline the Respondent pursuant to Chapters 455 and 465, Florida Statutes.

    
    

    Section 465.023(1)(c) provides as follows:

    
    

    1. The Department or the board may revoke or suspend the permit of any pharmacy permittee,

and may fine, place on probation, or otherwise discipline any pharmacy permittee who has:

1. Violated any of the requirements of this chapter or any of the rules of the Board of Pharmacy, . . . or of Chapter 893 . . . .

   
   

   24, Section 893.07(1)(b), Florida Statutes, provides as follows:

   
   

   1. Every person who engaged in the manufac- ture, compounding, mixing, cultivating, growing, or by any other process producing or preparing, or in the dispensing, importation, or as a wholesaler, distribution of controlled substances shall:

(b) On and after January 1, 1974, maintain, on a current basis, a complete and accurate record of each substance manufactured, received, sold, delivered, or otherwise dis- posed of by him, except that this Subsection shall not require the maintenance of a perpetual inventory.

1. The respondent failed to maintain, on a current basis, a complete and accurate record of all controlled substances received sold, delivered or otherwise disposed of. By violating section 893.07(1)(b), Florida Statutes, respondent is subject to disciplinary action pursuant to section 465.023(1)(c), Florida Statutes.

   
   

2. The Respondent violated Rule 215-1.14, Florida Administrative Code, by failing to properly secure the prescription department so as to prevent the entry into said department by persons not licensed to practice pharmacy. Respondent also violated Rule 215-1.24, Florida Administrative Code, by failing to meet the minimum operating hours of a prescription department. By violating rules 215-1.14 and 215-1.24, respondent is subject to disciplinary action under section 465.O23(1)(c), Florida Statutes.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that respondent violated

the requirements of section 893.07(1)(b), Florida Statutes, and rules 215-1.14

and 215-1.24, Florida Administrative Code, as alleged in Counts I, II and IV of the Administrative Complaint, and that, pursuant to section 465.023(1)(c), Florida Statutes, respondent be placed on probation for two (2) years, with the following terms:

1. Respondent shall be inspected two (2) times per year, and respondent shall pay the reasonable costs of such inspections.

   
   

2. Respondent shall remit a fine of $500 to the Board of Pharmacy within forty-five (45) days of filing the final order.

DONE and ENTERED this 28th day of January, 1986, in Tallahassee Leon County Florida.

DIANE A. GRUBBS

Hearing Officer

Division of Administrative Hearings The Oakland Building

2009 Apalachee Parkway

Tallahassee, Florida 32399-1550

(904) 488-9675

FILED with the Clerk of the Division of Administrative Hearings this 28th day of January 1986.

ENDNOTE

1/ Respondent stipulated at the hearing that the five drugs listed were controlled substances under Section 893.03(4), or "control fours."

APPENDIX

The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case.

Rulings On Proposed Findings of Fact Submitted by the Petitioner 1-3. Accepted in Findings of Fact 1-3.

4. Accepted, except as to the shortage of Tenuate and Librium, in Finding

of Fact 4. The evidence establishes that the shortage of Librium was 62 capsules and the shortage of Tenuate was 130 capsules. (Finding of Fact 7)

5-8. Accepted in substance in Finding of Fact 5.

1. Accepted in Finding of Fact 6.

2. Accepted as modified in Finding of Fact 6.

3. Accepted in Findings of Fact 6 and 9.

4. Accepted in Finding of Fact 7.

5. Accepted in Finding of Fact 8.

6. Accepted in Findings of Fact 6 and 9. 15-19. Accepted in Findings of Fact 10-14. 20-22. Accepted in Findings of Fact 16-17.

1. Accepted in Finding of Fact 18.

2. Accepted in Finding of Fact 19.

3. Rejected as conclusion of law.

4. Rejected as cumulative and as conclusion of law.

Rulings on Proposed Findings of Fact Submitted By Respondent 1-3. Accepted in Findings of Fact 1-3.

4. Accepted, except as to the shortage of Tenuate and Librium, in Finding

of Fact 4. The evidence establishes that the shortage of Librium was 62 capsules and the shortage of Tenuate was 130 capsules. (Finding of Fact 7.)

5-8. Accepted in substance in Finding of Fact 5.

1. Accepted in Finding of Fact 6.

2. Accepted as modified in Finding of Fact 7.

3. Accepted in Finding of Fact 8.

4. Accepted in Findings of Fact 6-9.

13-20. Accepted in Findings of Fact 10-17.

1. Rejected as contrary to stipulation and respondent's own proposed finding 420.

2. Accepted in Finding of Fact 18.

3. Accepted in Finding of Fact 19.

4. Rejected as not supported by competent evidence.

5. Accepted as modified in Finding of Fact 20.

6. Accepted in Finding of Fact 21.

7. Accepted as modified in Finding of Fact 22.

COPIES FURNISHED:

Bruce Douglas Lamb, Esquire Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

Kent Harrison Robbins, Esquire

370 Minorca Avenue

Coral Gables, Florida 33134

Fred Roche, Secretary

Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

Salvatore Carpino General Counsel

Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

Rod Presnell, Executive Director Department of Professional Regulation Board of Pharmacy

130 North Monroe Street Tallahassee, Florida 32301

Docket for Case No: 84-003732

Orders for Case No: 84-003732