STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF )

PHARMACY, )

)

Petitioner, )

)

vs. ) CASE NO. 83-1957

) DRUG MART, INC., OF LAKE )

WALES, d/b/a DRUG MART; and ) GERALD W. GETTEL, )

)

Respondents. )

)

RECOMMENDED ORDER

This is a disciplinary action brought by the Petitioner, Department of Professional Regulation, Board of Pharmacy, against the Respondents, Drug Mart, Inc., of Lake Wales, doing business as Drug Mart, and Gerald W. Gettel. The two-count Administrative Complaint filed by the Petitioner against the Respondent alleges that when inspected on or about March 30, 1982, the Respondents did not have on file the prescriptions for Schedule II controlled substances for the period from June 1980 through August 1980. Count I of the Administrative Complaint alleges that this constitutes a violation of Section

893.04(1)(d), Florida Statutes, which in turn constitutes a violation of Section 465.016(1)(e), Florida Statutes. Count II of the Administrative Complaint alleges that on said date the Respondents had not accounted for an unstated number of DEA 22 order forms; and that this constitutes a violation of Section 893.07, Florida Statutes, and thereby a violation of Section 415.016(1)(e), Florida Statutes.

After Notice of Hearing, the Petitioner and Respondents stipulated to the facts surrounding the case and to submission of the controversy to the Hearing Officer based upon their stipulation. It was the understanding of the parties and of the Hearing Officer that the parties would file briefs setting forth their positions with regard to the stipulated facts. Thereafter, counsel for the Respondents withdrew and briefs were not filed. On or about February 29, 1984, the Petitioner moved to allow the parties to file their briefs. This motion was granted, and the briefs were filed by the Petitioner on March 29 and by the Respondents on April 5, 1984.

Petitioner was represented by Bruce D. Lamb, Esquire, Department of Professional Regulation, 130 North Monroe Street, Tallahassee, Florida 32301; and the Respondents were represented by Richard G. Prosser, Esquire, who filed a notice of withdrawal on or about November 16, 1983. The stipulation entered into by the parties was executed on November 14, 1983, by Gerald W. Gettel for the Respondents, and Gettel subsequently filed the brief on behalf of the Respondents. The parties' briefs were read and considered. Those findings not incorporated herein are found to be subordinate, cumulative, immaterial, unnecessary, or not supported by the evidence.

The issue is whether the Respondents violated Sections 893.04(1)(d) and 893.07, Florida Statutes, which allegedly constitute a violation of Section 465.016(1)(e), Florida Statutes.

FINDINGS OF FACT

The following findings of fact are based upon the stipulation of the parties:

1. The Respondent pharmacy, Drug Mart, Inc., of Lake Wales, doing business as Drug Mart, is a corporation holding community pharmacy permit number 0007122.

   
   

2. The Respondent Gerald W. Gettel is a pharmacist licensed under the laws of the State of Florida, license number 0015091, whose last known address is 168 Poe Drive, Winter Haven, Florida 33890.

   
   

3. Pursuant to Section 465.081, Florida Statutes, Gettel was employed as the pharmacy department manager at Drug Mart, Inc., of Lake Wales, 608 Lake Wales Plaza, Lake Wales, Florida 33853.

   
   

4. On or about March 30, 1982, when inspected, the Respondents did not have on file Schedule II controlled substance prescriptions for the period of June 1980 through and including August 1980.

   
   

5. If a hearing had been held in this case, Respondent Gettel would have testified that the destruction of the Schedule II controlled substance prescriptions mentioned above was unintentional . Gettel's testimony would have been supported by two witnesses whose affidavits are attached to this Recommended Order as Exhibits A and B.

   
   

6. At a hearing, Gettel would have testified he could reproduce from computer records all of the dispensing information contained on the original prescriptions but admits it is accepted practice of pharmacists to maintain the original Schedule II controlled substance prescriptions for a period of two years.

   
   

7. It is specifically stipulated that Schedule II controlled substance prescriptions are not subject to the exceptions provided by Section 893.07(4)(b), Florida Statutes.

   
   

8. The responsibility for maintaining Schedule II controlled substance records is imposed upon the pharmacy manager (per the stipulation of the parties; however, the law is contrary). The permit holder, Drug Mart, Inc., of Lake Wales, is not directly responsible for the maintenance of said records.

   
   

9. The Respondent Gettel notified the Drug Enforcement Administration of the destruction of the subject prescriptions. (See Exhibits C and D attached hereto.)

   
   

10. At a hearing, Gettel would have stated that he also notified the Board of Pharmacy and would have introduced a letter and certified mail receipt relating to this notice to the Board. (See Exhibit E attached hereto.)

    
    

11. If called to testify, the custodian of records of the Board of Pharmacy would state that the Board does not have a copy of the above-referenced

    letter (Exhibit E) in Respondent Gettel's file or in the Board's records of correspondence relating to lost or destroyed drugs or records.

    
    

12. At a hearing, the Petitioner would offer no testimony contrary to the tendered testimony of Respondent Gettel and the referenced exhibits regarding the destruction of the subject records.

    
    

    CONCLUSIONS OF LAW

    
    

13. The Board of Pharmacy has jurisdiction pursuant to Chapter 465, Florida Statutes, to discipline licensed pharmacists and holders of community pharmacy permits. This Recommended Order is entered pursuant to the provisions of Section 120.57(1), Florida Statutes, and through the stipulation of the parties to submit this controversy upon said stipulation. It was the intent of the parties to have the tendered testimony in the stipulation considered as the facts together with the supporting exhibits.

    
    

14. In summary, an inspection of the Respondent pharmacy revealed that the records referenced in Count I of the Administrative Complaint were not present. Respondent Gettel became aware that said records had been inadvertently destroyed and notified the Drug Enforcement Administration and the Board of Pharmacy of said destruction. Gettel had caused the essential information contained on the actual prescriptions to be entered into the Respondent pharmacy's computer. From this source, the information contained in the destroyed records could be reproduced. No evidence or testimony to the contrary could be introduced by the Petitioner. No evidence regarding the allegations contained in Count II of the Administrative Complaint was introduced.

    
    

15. Section 893.04(1)(d), Florida Statutes, which the Respondents are charged with violating, provides as follows:

    
    

    1. 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, under the following conditions:

       * * *

       (d) The prescription shall be retained on file by the proprietor of the pharmacy in which it is filled for a period of 2 years.

       
       

16. The Petitioner has charged the Respondents with failure to retain on file prescription records for Schedule II controlled substances. It is asserted by the Petitioner that this constitutes a violation of Section 893.04(1)(d), Florida Statutes, and thereby a violation of Section 465.016, Florida Statutes. It is concluded that the Respondents did not violate this statute as alleged for the following reasons:

    
    

    1. Section 894.04(1)(d), supra, is not a disciplinary statute. It sets forth certain conditions which must be met by pharmacists in order to dispense controlled substances. One of these conditions is that the records be maintained on file for a period of two years. Presumably, if the records were not maintained on file for a period of two years, the condition under which controlled substances could be dispensed would not be met. The record in this cause indicates that when the Respondent Gettel determined this situation

       existed, he notified DEA and the Board of Pharmacy. Apparently, the Board misplaced its copy of this notification; however, DEA advised Gettel that it intended to take no further action concerning the matter. Presumably, Gettel was free at this point to dispense controlled substances under the provisions of Sections 893.04(1)(d), Florida Statutes, because he was maintaining his current records as required. No evidence was received that the Respondents failed to retain said records for current prescriptions.

       
       

    2. Further, the provisions of Section 893.04(1)(d), Florida Statutes, place the responsibility of maintaining such records on the proprietor of the pharmacy. Notwithstanding the stipulation of the parties that the pharmacy manager is responsible, it is the proprietor of the pharmacy who is required by Chapter 893, Florida Statutes, to maintain on file prescription records. A proprietor is defined by Black's Law Dictionary and by Webster's New Collegiate Dictionary as one who has a legal right to anything or something. In many instances, "proprietor" is synonymous with "owner." No evidence has been presented that the Respondent Gettel is the proprietor of the Respondent pharmacy. Therefore, if one assumes that Section 893.04(1)(d), Florida Statutes, was violated, it is the permit holder or proprietor who is responsible. Discipline of a pharmacy permittee is controlled by Section 465.023, Florida Statutes; however, the Administrative Complaint limits its allegations to violation of Chapter 893, Florida Statutes, by Gettel under Section 465.016, Florida Statutes. It is further noted that Section 465.018, Florida Statutes, provides that "no permit shall be issued unless a licensed pharmacist is designated as the prescription department manager responsible for maintaining all drug records . . . ." (Emphasis supplied.) Therefore, the unique situation exists in which Chapter 893, supra, which is the statute primarily devoted to the regulation of drugs and drug records, places the burden of maintaining said records on the proprietor; however, Chapter 465, Florida Statutes, governing pharmacy and under which this action is brought, specifically relieves the pharmacy permittee (proprietor) of this obligation. Therefore, if the Respondent pharmacy is responsible for the purported violation of Chapter 893, then Chapter 465, supra, does not provide for the discipline of the pharmacy permittee. However, the Administrative Complaint charges the Respondent Gettel with violating Chapter 893, supra. As stated above, Chapter 893 places the responsibility of keeping drug records on the proprietor; therefore, Gettel did not violate Chapter 893 or Section 465.016, Florida Statutes.

       
       

    3. Lastly, based upon the stipulation of the parties and the information which is before the Hearing Officer, the destruction of the subject records was accidental. Neither Chapter 893 nor Chapter 465, Florida Statutes, was intended to discipline pharmacy permittees or licensees for the accidental destruction of such records. The Respondent Gettel took action to notify the appropriate authorities of the destruction of the subject records, at which point he had done all that he could do.

    
    

17. For the reasons stated above, it is concluded that the actions of the Respondents are not in violation of the statutes as alleged.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the Administrative Complaint filed against the Respondents be dismissed.

DONE AND ENTERED this 3rd day of May, 1984, in Tallahassee, Leon County, Florida.

STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway

Tallahassee, Florida 32301 904/488-9675

Filed with the Clerk of the Division of Administrative Hearings this 3rd day of April, 1984.

COPIES FURNISHED:

Bruce D. Lamb, Esquire Department of Professional

Regulation

130 North Monroe Street Tallahassee, Florida 32301

Mr. Gerald W. Gettel

168 Poe Drive

Winter Haven, Florida 33880

Drug Mart, Inc., of Lake Wales 608 Lake Wales Plaza

Lake Wales, Florida 33853

Frederick Roche, Secretary Department of Professional

Regulation

130 North Monroe Street Tallahassee, Florida 32301

Wanda Willis, Executive Director Board of Pharmacy

130 North Monroe Street Tallahassee, Florida 32301

Docket for Case No: 83-001957

Orders for Case No: 83-001957