STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, )

BOARD OF PHARMACY, )

)

Petitioner, )

)

vs. ) Case No. 00-0375

)

AZUBUEZE IKEJIANI, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a formal hearing was held in this case on March 24, 2000, at Miami, Florida, before Susan B. Kirkland, a designated Administrative Law Judge of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Lawrence F. Kranert, Jr., Esquire

Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 32317-4229

For Respondent: Azubueze Ikejiani, pro se

2321 Dunhill Avenue

Hollywood, Florida 33025-3815 STATEMENT OF THE ISSUES

Whether Respondent violated Sections 465.016(1)(e), 465.018, and 893.07(1)(b), Florida Statutes, and Rules 64B16-28.107(2)(b), 64B16-28.110, and 64B16-28.140(3)(c), (d), and (e), Florida

Administrative Code, and if so, what penalty should be imposed.

PRELIMINARY STATEMENT

On September 24, 1998, Petitioner, Department of Health (Department), filed an Administrative Complaint against Respondent, Azubueze Ikejiani (Ikejiani), alleging that he violated Rule 64B16-28.107(2)(b), Florida Administrative Code, by failing to ensure that the prescription department had one set of prescription weights in good condition; that he violated

Rule 64B16-28.110, Florida Administrative Code, by failing to ensure that outdated pharmaceuticals were removed from the pharmacy; that he violated Section 893.07(1)(b), Florida Statutes, by failing to have available for inspection a biennial controlled substance inventory; and that he violated

Rule 64B16-28.104(3)(c), (d), and (e), Florida Administrative Code, by failing to maintain a certified daily log or printout of dispensed medications. Ikejiani requested an administrative hearing, and the case was forwarded to the Division of Administrative Hearings for assignment to an Administrative Law Judge.

At the final hearing Petitioner called Ikejiani and Harold Gluck as its witnesses. Petitioner's Exhibit 1 was entered into evidence. Respondent testified in his own behalf and presented no exhibits.

Official recognition was taken of Sections 455.594, 455.621, 455.624, 455.681, 465.016-465.019, 465.0193, 465.0196, 465.015,

465.0155, 465,156, 465.009, 465.012, and 465.008, Florida

Statutes, and Rules 64B16-28.110, 64B16-28.109, 64B16-28.101, 64B16-28.107, 64B16-28.140, 64B16-28.404, 64B16-26.103,

64B16-26.603, and 64B16-26.606 and Chapter 64B16-30, Florida Administrative Code.

At the final hearing the parties agreed to file proposed recommended orders within ten days of the filing of the Transcript, which was filed on April 13, 2000. The time for filing proposed recommended orders was extended to June 9, 2000. Neither Petitioner nor Respondent filed a proposed recommended order.

FINDINGS OF FACT

1. Ikejiani has held a pharmacist license since 1987. In February 1997, Ikejiani was the owner and pharmacy manager of Makgoni Pharmaceuticals, which was doing business as Citadel Pharmacy (Citadel). The business was located at 5301 Northeast 2nd Avenue, Miami, Florida. Citadel is a community pharmacy.

2. The posted pharmacy hours for Citadel were 10:00 a.m. to 6:00 p.m. Monday through Friday, and 10:00 a.m. to 4:00 p.m. on Saturday.

3. On February 14, 1997, Harold Gluck (Gluck), an inspector for the Department, visited Citadel at 12:10 p.m. There was a sign in the pharmacy area, indicating that the pharmacy portion of the business was closed. There was no pharmacist on duty. Ikejiani was a few doors down visiting a doctor. Although there

   was a clerk on duty at the business, she did not advise Gluck of the whereabouts of Ikejiani.

4. On February 17, 1997, Gluck returned to Citadel at 10:45 a.m. to inspect the pharmacy. Again, no pharmacist was present, and there was a "Closed" sign in the pharmacy area.

5. On February 18, 1997, Gluck visited Citadel at 1:20 p.m. No pharmacist was present, and the pharmacy was closed.

6. On February 26, 1997, Gluck returned to Citadel, where Ikejiani was present and the pharmacy was open for business. Gluck inspected the premises and found a pharmacy balance but no weights. Each pharmacy is required to have a balance and weights to be used when there is a prescription which requires that the ingredients be measured.

7. Gluck found approximately 70 bottles of expired legend drugs on the pharmacy shelves. The 70 bottles were not located in a section for expired drugs, but were interspersed with the regular drugs. No evidence was presented as to the expiration dates of the 70 bottles. In the refrigerator among the regular drugs, he found five pints of erythromycin, which had expired approximately five months before the inspection.

8. Gluck observed other expired medications which were in boxes on the floor of the pharmacy. These medications were not with the regular merchandize and were to be shipped by the manufacturer for a refund.

9. Ikejiani did not have a controlled substance inventory. He did have controlled III and IV substances on the shelves, including such things as cough syrup made with a codeine preparation, and sleeping pills.

10. Ikejiani was maintaining his certified log of deliveries and prescriptions of legend and controlled substances on a monthly basis, rather than on a daily basis.

    CONCLUSIONS OF LAW

    
    

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

12. In Count I of the Administrative Complaint, the Department alleged that Ikejiani violated

    Rule 64B16-28.107(2)(b), Florida Administrative Code, which provides that the prescription department of a pharmacy shall have the following items:

    (2) The prescription department of any pharmacy permittee unless otherwise required by these rules shall have such other equipment as is necessary to meet the needs of the professional practice of pharmacy including:

    * * *

    
    

    (b) One set of prescription weights in good condition;

    
    

13. Ikejiani violated Rule 64B16-28.107(2)(b), Florida Administrative Code, by failing to have a set of prescription weights for the prescription department of Citadel.

14. In Count II of the Administrative Complaint, the Department alleged that Ikejiani violated Rule 64B16-28.110, Administrative Code, which provides:

    Persons qualified to do so shall examine the stock of the prescription department of each pharmacy at a minimum interval of four months, and shall remove all deteriorated pharmaceuticals, or pharmaceuticals which bear upon the container an expiration date which date has been reached, and under no circumstances will pharmaceuticals or devices which bear upon the container an expiration date which has been reached be sold or dispensed to the public.

15. Ikejiani violated 64B16-28.110, Florida Administrative Code, by having five pints of erythromycin, which had been expired for five months, in with the regular pharmaceuticals. Rule 64B16-28.110, Florida Administrative Code, requires the stock to be examined every four months at a minimum. Thus, it is possible to have expired medications on the shelves which have been expired less than four months and still not be in violation of the rule. There was no evidence presented to indicate how long the 70 bottles of medicine pulled from the shelves had been expired. No evidence was presented to show that Ikejiani had sold or dispensed medications which had expired.

16. The Department has alleged that Respondent violated Section 465.016(1)(e), Florida Statutes, which provides that the following acts shall be grounds for Disciplinary action:

    (e) Violating any of the requirements of this chapter; or if licensed as a practitioner in this or any other state, violating any of the requirements of their

    respective practice act or violating chapter 499; 21 U.S.C. ss. 301-392, known as the Federal Food, Drug, and Cosmetic Act; 21

    U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse Prevention and Control Act; or chapter 893.

    
    

17. In Count III of the Administrative Complaint, the Department alleges that Ikejiani violated Sections 465.016(1)(e) and 893.07(1)(b), Florida Statutes, which provide:

    1. Every person who engages in the manufacture, 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:

       
       

       * * *

       
       

       1. 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 disposed of by him or her, except that this subsection shall not require the maintenance of a perpetual inventory. Compliance with the provisions of federal law pertaining to the keeping of records of controlled substances shall be deemed a compliance with the requirements of this subsection.

18. Ikejiani violated Section 893.07(1)(b), Florida Statutes, because he failed to maintain an inventory of controlled substances.

19. In Count IV of the Administrative Complaint, the Department alleges that Ikejiani violated

    Rule 64B16-28.140(3)(c), (d), and (e), Florida Administrative Code, which pertains to records of dispensing prescriptions and provides:

    1. The daily hard-copy printout shall be produced within 72 hours of the date on which the prescription drug orders were dispensed and shall be maintained in a separate file at the pharmacy. Records of controlled substances shall be readily retrievable from records of non-controlled substances.

    2. Each individual pharmacist who dispenses or refills a prescription drug order shall verify that the data indicated on the daily hard-copy printout is correct, by dating and signing such document in the same manner as signing a check or legal document (e.g., J. H. Smith, or John H. Smith) within seven days from the date of dispensing.

    3. In lieu of producing the printout described in subparagraphs (b) and (c) of this section, the pharmacy shall maintain a log book in which each individual pharmacist using the data processing system shall sign a statement each day, attesting to the fact that the information entered into the data processing system that day has been reviewed by him or her and is correct as entered.

    Such log book shall be maintained at the pharmacy employing such a system for a period of two years after the date of dispensing provided, however, that the data processing system can produce the hard-copy printout on demand by an authorized agent of the Department of Health. If no printer is available on site, the hard-copy printout shall be available within 48 hours with a certification by the individual providing the printout, which states that the printout is true and correct as of the date of entry and such information has not been altered, amended or modified.

20. Ikejiani violated Rule 64B16-28.140(3)(c), (d), and (e), Florida Administrative Code, because he was maintaining his dispensing records on a monthly basis rather than a daily basis as required.

21. Rule 64B16-30.001, Florida Administrative Code, provides disciplinary guidelines, including a range of penalties

for violations of Chapter 465, Florida Statutes, and the rules promulgated thereto. The penalty range for violations of Rules 64B16-28.107 and 64B16-28.110, Florida Administrative Code, is a

$500 fine to one-year probation and $1,000 fine. The penalty range for a violation of Section 893.07(1)(b), Florida Statues, is a $1,000 fine and one-year probation to revocation. No penalty range could be found for a violation of Rule 64B16- 28.140.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Azubueze Ikejiani violated Rules 64B16-28.107(2)(b), 64B16- 28.110, and 64B16-28.140(3)(c), (d), and (c), Florida Administrative Code, and Section 893.07(1)(b), Florida Statutes, and imposing a $500 fine for the violation of Rule 64B16-28.107, Florida Administrative Code, a $1,000 fine for the violation of Rule 64B16-28.110, Florida Administrative Code, a $1,000 fine and one-year probation for violation of Section 893.07(1)(b), Florida Statutes, and a $500 fine for violation of Rule 64B16-28.140, Florida Administrative Code.

DONE AND ENTERED this 16th day of June, 2000, in Tallahassee, Leon County, Florida.

SUSAN B. KIRKLAND

Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488-9675 SUNCOM 278-9675

Fax Filing (850) 921-6847 www.doah.state.fl.us

Filed with the Clerk of the Division of Administrative Hearings this 16th day of June, 2000.

COPIES FURNISHED:

Lawrence F. Kranert, Jr., Esquire Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 33217-4229

Azubueze Ikejiani 2321 Dunhill Avenue

Hollywood, Florida 33025-3815

John Taylor, Executive Director Board of Pharmacy

Department of Health 1940 North Monroe Street

Tallahassee, Florida 32399-0750

Amy M. Jones, General Counsel Department of Health

Bin A02

2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701

Angela T. Hall, Agency Clerk Department of Health

Bin A02

2020 Capital Circle, Southeast Tallahassee, Florida 32399-1703

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within 15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.

Docket for Case No: 00-000375

Orders for Case No: 00-000375