STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

STATE OF FLORIDA, DEPARTMENT OF ) PROFESSIONAL REGULATION (Board )

of Pharmacy), )

)

Petitioner, )

)

vs. ) CASE NO. 81-1873

)

KARL L. SMITH, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a hearing was held before Charles C. Adams, a Hearing Officer with the Division of Administrative Hearings. This hearing was conducted in the Richard P. Daniel Building, 111 Coast Line Drive East, Jacksonville, Florida, on December 10, 1981. This Recommended Order is being entered following the receipt of proposed recommended orders filed by counsel for the parties. The receipt date by the Division of Administrative Hearings for the last installment of those proposals was January 25, 1982. 1/

APPEARANCES

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

119 North Monroe Street Tallahassee, Florida 32301

For Respondent: Joseph S. Farley, Jr., Esquire

350 East Adams Street Jacksonville, Florida 32202

ISSUES

The matters presented here concern action by an Administrative Complaint filed by the Petitioner against the the named Respondent. By this action, the Petitioner seeks to suspend, revoke or take other disciplinary action against the Respondent.

In particular, it is alleged that, in keeping with a controlled substance audit at the Medical Center Pharmacy, certain drug shortages were discovered, namely: (a) Between September 1, 1980, and January 28, 1981, 38,190 unit doses of Talwin 50 mg., a controlled substance; (b) Between September 1, 1980, and January 28, 1981, 16,920 unit doses of Pyribensamine (PBZ), and (c) between the dates of October 4, 1980, and January 29, 1981, 285 unit doses of Percodan.

By Count I to the Administrative Complaint, it is alleged that, based upon the facts as set forth above, the Respondent has violated Subsection 465.016(1)(a), Florida Statutes, by violating Subsection 893.07(2), Florida

Statutes, dealing with failure to maintain proper records of controlled substances.

Count II to the Administrative Complaint states that based upon the alleged facts, the Respondent has violated Subsection 465.016(1)(i), Florida Statutes, by compounding, dispensing, or distributing a legend drug, including any controlled substance, other than in the course of professional practice of pharmacy.

Count III alleges a violation of Subsection 465.016(1)(e) Florida Statutes, in view of a violation of Rule 21S-1.114, Florida Administrative Code, for failure to close the pharmacy when a registered pharmacist was not present and on duty related to acts which occurred on January 28, 1981, during the audit.

Count IV alleges a violation of Subsection 465.016(1)(e) Florida Statutes, by violating Rule 21S-1.24(4), Florida Administrative Code, for alleged failure to display hours of operation at the pharmacy, based upon observations during the January 28, 1981, audit conducted at the pharmacy. 2/

FINDINGS OF FACT

1. This cause is presented based upon the Administrative Complaint which has been alluded to in the Issues statement to this Recommended Order. That complaint was filed June 4, 1981, and in the face of the Administrative Complaint, the Respondent, by execution of an Election of Rights form on July 10, 1981, indicated that certain material allegations of fact set forth in the Administrative Complaint were in dispute and requested a formal hearing in keeping with Subsection 120.57(1), Florida Statutes.

   
   

2. The petitioning agency in this matter is a governmental body in the State of Florida, which has the power to license, regulate and discipline individuals and entities holding licenses or permits to practice pharmacy in the State of Florida. See Chapters 455 and 465, Florida Statutes.

   
   

3. Karl L. Smith is registered by the Board of Pharmacy in the State of Florida to be a pharmacist and holds License No. 141337.

   
   

4. Edgewood Medical Center Pharmacy, Inc., which did business, at all times pertinent to this Administrative Complaint, as Medical Center Pharmacy, is a community pharmacy licensed by the State of Florida to operate as a pharmacy under the terms of Permit No. 0007060. During the period in question, this pharmacy was located at 3160 West Edgewood Avenue, Jacksonville, Florida. At all times pertinent, Karl L. Smith was the only licensed pharmacist for Medical Center Pharmacy.

   
   

5. On January 28, 1981, Petitioner's Investigators C. J. Hokinson and Johnny Danson proceeded to the Medical Center Pharmacy for purposes of conducting an audit of select controlled substances and legend drugs.

   
   

6. When the Investigators entered the pharmacy, they spoke with Karl L. Smith who allowed them to examine pharmacy records related to Talwin, a Schedule IV drug and Pyribensamine, a legend drug.

   
   

7. The audit process utilized for Talwin started with a zero inventory balance on September 2, 1980, and ended on January 28, 1981, with a total purchase count in the audit period of 39,200 unit doses. There remained on hand at the pharmacy 160 unit doses of the drug and some 850 unit doses were shown to

   be disposed of by prescription sale. There remained 38,190 unit doses of Talwin unaccounted for by explanation or documentation.

   
   

8. An examination on January 28, 1981, of the second drug Pyribensamine, started with the zero inventory dating from September 2, 1980, and the audit period ended January 28, 1981. Within the audit period, there were 17,200 unit doses shown to have been purchased. On hand at the pharmacy on the date of the audit, 100 unit doses were found. An additional 180 unit doses had been dispensed by prescription sale. There remained 16,920 unit doses of Pyribensamine which were unaccounted for by explanation or documentation.

   
   

9. While conducting the audit on January 28, 1981, Karl L. Smith, the only registered pharmacist on the premises left the pharmacy without closing it and Kathy Elain Smith, an intern pharmacist not admitted to practice pharmacy, was left in charge. Further the hours of operation for the pharmacy were not posted at the pharmacy on that date.

   
   

10. On January 29, 1981, Investigator Danson returned to the pharmacy to conduct an audit for Percodan, a Schedule II drug. The audit period on this occasion started with a zero inventory for October 1, 1980, and the last day of the audit period was January 1, 1981. During this time frame, 1,000 unit doses had been purchased and 560 unit doses were on hand at the pharmacy on the date of the audit. Another 155 unit doses had been dispensed by prescription sale and 285 unit doses were unaccounted for by explanation or documentation.

    
    

11. (The exact whereabouts of the missing drug items were not established. Karl L. Smith indicated that those drugs could have been removed by "friends" whom he had allowed to work in the pharmacy with him. No further explanation of the location of the missing drugs was volunteered, notwithstanding the fact that Karl L. Smith had been afforded several opportunities to explain what happened to the missing drugs.)

    
    

    CONCLUSIONS OF LAW

    
    

12. The Division of Administrative Hearings has jurisdiction over the subject matter and the parties to this action pursuant to Subsection 120.57(1), Florida Statutes.

    
    

13. In connection with Count I, the facts revealed that the Respondent, Karl L. Smith, failed to maintain proper records of the controlled substances Talwin and Percodan, in that no records were found concerning the missing unit doses pertaining to those substances as discovered in the audit, contrary to Section 893.07, Florida Statutes, and in particular, Subsection 893.07(2), Florida Statutes.

    
    

14. In turn, Subsection 465.016(1)(e), Florida Statutes, subjects the Respondent to disciplinary action for violating the provisions of Chapter 893, Florida Statutes.

    
    

15. In connection with Count II, the Respondent is charged with the violation of Subsection 465.016(1)(i), Florida Statutes. This provision makes it a violation to compound, dispense or distribute a legend drug, to include controlled substances other than in the course of professional practices. This provision goes on to state that there is a legal presumption that compounding, dispensing or distributing legend drugs in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the professional practice of pharmacy.

16. While there is ample proof of the fact that these drugs in whatever composition were dispensed or distributed, and there is ample evidence to the effect that Talwin, Pyribensamine and Percodan are within the category of drugs contemplated by this provision, the proof is insufficient to demonstrate that Karl L. Smith was responsible for this violation.

    
    

17. Count III to the Administrative Complaint charges a violation by Karl

    L. Smith for failure to close the pharmacy when a registered pharmacist was not present and on duty. Rule 21S-1.114, Florida Administrative Code. In turn, it is alleged that the violation of this rule provision causes a violation of Subsection 465.016(1)(e), Florida Statutes, and subjects the Respondent to the penalties set forth therein.

    
    

18. On January 28, 1981, Karl L. Smith, as the pharmacist in charge of Medical Center Pharmacy, left that pharmacy open for business at a time when a Florida registered pharmacist was not present and on duty and therefore violated Rule 21S-1.14, Florida Administrative Code; however, violation of this administrative rule does not subject the Respondent, Karl L. Smith, to disciplinary action under Subsection 465.016(1)(e), Florida Statutes. This conclusion is reached because the subject rule in keeping with Section 465.022, Florida Statutes, establishes specific requirements for community pharmacy permit holders, not individual licensed pharmacists. Therefore, the Respondent pharmacist cannot be held to have violated any legal requirement contemplated in the disciplinary provision. Subsection 465.016(1)(e) Florida Statutes.

    
    

19. Count IV of the Administrative Complaint alleges that Karl L. Smith violated Rule 21S-1.24(1), Florida Administrative Code, by failing to display the hours of operation of a medical center pharmacy and in turn is subject to the penalties set forth in Subsection 465.016(1)(e), Florida Statutes.

    
    

20. On January 28, 1981, the hours had not been posted concerning the operation of the pharmacy contrary to Rule 21S-1.24(1), Florida Administrative Code. Nonetheless, for reasons discussed in analyzing Count III to this Administrative Complaint, the violation of this rule provision does not subject the Respondent to the penalties set forth in Subsection 465.016(1)(e) , Florida Statutes; i.e., the rules provision pertains to community pharmacy permit holders as contemplated in Section 465.022, Florida Statutes, and not to licensed pharmacists within the meaning of Section 465.016, Florida Statutes. Consequently, the Petitioner has failed to prove a violation of Count IV.

Based upon a full consideration of the Findings of Fact, Conclusions of Law, Proposed Recommended Orders and other appropriate matters, it is RECOMMENDED:

That a final order be entered dismissing Counts II, III, IV and V and revoking the license of Karl L. Smith for the violation established through Count I.

DONE and ENTERED this 3rd day of February, 1982, in Tallahassee, Florida.

CHARLES C. ADAMS

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 3rd day of February, 1982.

ENDNOTES

1/ The proposed recommended orders have been reviewed prior to the entry of this Recommended Order. To the extent that those proposals are consistent with this Recommended Order, they have been utilized. To the extent that the proposals are inconsistent with the Recommended Order, they are hereby rejected.

2/ The Administrative Complaint had contained allegations under a Count V however, that count was voluntarily dismissed at the commencement of the hearing and no further treatment shall be made to that aspect of the Administrative Complaint.

COPIES FURNISHED:

W. Douglas Moody, Jr., Esquire

119 North Monroe Street Tallahassee, Florida 32301

Joseph S. Farley, Jr., Esquire

350 East Adams Street Jacksonville, Florida 32202

Samuel Shorstein, Secretary Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

Docket for Case No: 81-001873

Orders for Case No: 81-001873