STATE OF FLORIDA DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF )

PHARMACY, )

)

Petitioner, )

)

vs. ) CASE NO. 91-4822

)

OBI E. ENEMCHUKWU, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, the above matter was heard before the Division of Administrative Hearings by its duly designated Hearing Officer, Donald R. Alexander, on February 24, 1992, in Tavares, Florida.

APPEARANCES

For Petitioner: Tracey S. Hartman, Esquire

1940 North Monroe Street, Suite 60

Tallahassee, Florida 32399-0792

For Respondent: Obi E. Enemchukwu, pro se

P. O. Box 32

Tavares, Florida 32778-0032 STATEMENT OF THE ISSUES

The issue is whether respondent's license as a pharmacist should be disciplined for the reasons cited in the administrative complaint, as amended.

PRELIMINARY STATEMENT

This matter began on July 5, 1991, when petitioner, Department of Professional Regulation, Board of Pharmacy (Board), issued a four-count administrative complaint charging respondent, Obi E. Enemchkwu, a licensed pharmacist, with having violated Rule 21S-1.014, Florida Administrative Code, and Sections 465.014, 465.015((2)(c), and 465.016((1)(e) and (n), Florida Statutes (1989) by (a) opening the prescription department without a registered pharmacist on duty, (b) allowing pharmacy technicians to dispense medicinal drugs without a pharmacist being present, and (c) twice refilling a prescription for medicinal drugs without authorization from the prescribing physician. In addition, the complaint alleged that a pharmacy permittee (respondent) violated Rule 21S-1.023 by violating a provision of state law and thus was subject to discipline under the provisions of Subsection 465.023(1)(c), Florida Statutes (1989). Respondent disputed the above allegations and requested a formal hearing. The matter was referred by petitioner to the Division of Administrative Hearings on July 31, 1991, with a request that a Hearing Officer be assigned to conduct a formal hearing.

By notice of hearing issued on August 20, 1991, the matter was scheduled for final hearing on November 27, 1991, in Tavares, Florida. At petitioner's request the matter was rescheduled to February 24, 1992, at the same location. On February 20, 1992, the case was transferred from Hearing Officer Ella Jane P. Davis to the undersigned.

On December 16, 1991, petitioner filed a motion to amend its administrative complaint. The motion was granted by order dated January 7, 1992.

At final hearing, petitioner presented the testimony of Charles C. Lewis, a DPR senior pharmacist and a registered pharmacist since 1975. Also, it offered petitioner's exhibits 1 and 2. Both exhibits were received in evidence. The exhibits are the depositions of Dr. James E. Quinn, a Sanford, Florida medical doctor, and Dr. Michael A. Meyer, a Sanford, Florida doctor of osteopathic medicine. Although respondent was properly noticed for the depositions he did not attend. Respondent testified on his own behalf.

A transcript of hearing was filed on March 6, 1992. The parties waived their right to file proposed findings of fact and conclusions of law.

FINDINGS OF FACT

Based upon the entire record, the following findings of fact are determined:

1. Background

   
   

   1. At all times relevant hereto, respondent, Obi E. Enemchukwu, was licensed as a pharmacist having been issued license number PS 0023082 by petitioner, Department of Professional Regulation, Board of Pharmacy (Board). He has been licensed as a pharmacist since 1981. There is no evidence that respondent has been the subject of disciplinary action prior to this occasion.

      
      

   2. When the events herein occurred, respondent was the designated prescription department manager and pharmacy permittee for Oviedo Drug World (ODW), a community pharmacy located at 83 Geneva Drive, Oviedo, Florida. A community pharmacy is not defined by statute or rule. However, a Board witness described such a pharmacy as being a drug store that serves customers in an outpatient or ambulatory setting. As the prescription manager for the pharmacy, respondent was responsible for maintaining all drug records, providing for the security of the prescription department, and following all other rules governing the practice of pharmacy.

      
      

2. Count I

   
   

   1. This count alleges that respondent violated a Board rule by virtue of the ODW prescription department being "opened at 9:00 a.m. with a pharmacy technician only on duty with no pharmacist present until approximately 9:15 a.m.". In this regard, the evidence shows that on February 28, 1991, a DPR senior pharmacist, Charles C. Lewis, made a routine inspection of ODW. He entered the premises at approximately 9:00 a.m. and found the drug store open, the lights on in the pharmacy section, and only a pharmacist technician on duty. Respondent was not on the premises. Respondent eventually entered the premises around 9:10 a.m. Because the law requires that a registered pharmacist be on duty whenever a community pharmacy is open, respondent, as the designated manager, was in contravention of that requirement.

3. Count II

   
   

   1. The second count alleges that "on one occasion in approximately August 1990, pharmacist technicians on duty were required to dispense medicinal drugs despite no pharmacist having been present". As to this charge, respondent admitted without further proof that the allegations were true. Thus, the charge in Count II has been sustained.

      
      

4. Count III

1. The third count alleges that "on at least two occasions refills for medicinal drugs were dispensed without authorization from the prescribing physician." As to this count, during the course of his inspection of ODW's prescription file, Lewis found copies of two original prescriptions dispensed by respondent on Saturday, February 9, 1991, and Saturday, February 16, 1991, respectively. Original prescriptions are those either handwritten by a doctor and brought in for filling by the patient or those that are telephoned in to the pharmacy by the doctor's office. If a prescription is telephoned in, it must be immediately reduced to writing by the pharmacist. Original prescriptions do not include refills. In this case, the two prescriptions were the type telephoned in by the doctor directly to the pharmacy. Because doctors are rarely in their offices on Saturday, Lewis turned the prescription records over to DPR for further investigation. The records of the prescriptions have been received in evidence as a part of petitioner's exhibits 1 and 2. The prescriptions indicate that Dr. James E. Quinn prescribed thirty Nalfon tablets (600 mg.) to patient L.

   C. on February 9, 1991, and Dr. Michael E. Meyer prescribed ten Tagamet tablets (300 mg.) to patient J. K. on February 16, 1991. The record does not disclose whether the drugs are scheduled legend drugs or non-scheduled legend drugs.

   
   

2. Deposition testimony given by Drs. Quinn and Meyer established that neither doctor authorized by telephone or in writing that the two prescriptions in question be filled. Respondent concedes that he dispensed the drugs, and by doing so, he violated the law.

   
   

   1. Count IV

      
      

3. The final count alleges that respondent, as a pharmacy permittee, violated former rule 21S-1.023 (now renumbered as rule 21S-28.112) by dispensing a medicinal drug in violation of state law. Because this charge is founded on the same set of facts set forth in findings of fact 4, 5 and 6, it is found that this charge has been sustained.

   
   

   1. Mitigation and Penalty

   
   

4. At hearing, respondent generally offered mitigating testimony. As to Count I, he indicated he planned to arrive at the store at 9:00 a.m. but an automobile accident tied up traffic and caused him to be ten minutes late. He suspects that the store owner, who had the only other set of keys, opened up the store and pharmacy area and improperly let the technician into the pharmacy area even though respondent had not yet arrived. As to Count II, respondent acknowledged that two prescriptions were dispensed by pharmacy technicians without a pharmacist on duty but believes the store owner authorized the technician to dispense two prescriptions that he had filled the previous evening. He says appropriate instructions have been given to insure that this will not occur again. Finally, respondent gave the following explanation for dispensing the two prescriptions without authorization from a doctor. During

   the time period in question, respondent had a practice of partially filling prescriptions. In other words, even though a prescription might authorize a total of 100 tablets, respondent would dispense them piecemeal (e.g., 10 at a time) over the life of the prescription. Thus, at the end of the prescription period, if only 80 of 100 tablets had been previously dispensed, he would fill the remaining 20 tablets even though the prescription from a particular doctor had expired. In the case of the two prescriptions in issue, respondent believes that the customers either had a valid prescription from another doctor but he inadvertently refilled the prescription using the former doctor's name because the prescription had not been used up, or he noted that the patient had not been given the total number of tablets authorized under the original prescription.

   However, no documentation was submitted by respondent to support the claim that he was presented with a new valid prescription by one of the customers.

   Respondent apparently no longer engages in this practice. Finally, throughout the course of this proceeding, respondent has fully cooperated with the Board.

   
   

5. Although the Board did not submit a proposed order containing a recommended penalty, at hearing counsel for the Board suggested that respondent's conduct warrants the imposition of a fine, probation and a reprimand.

   
   

   CONCLUSIONS OF LAW

   
   

6. The Division of Administrative Hearings has jurisdiction of the subject matter and the parties hereto pursuant to Subsection 120.57(1), Florida Statutes (1991).

   
   

7. Because respondent's professional license is at risk, petitioner is obligated to prove the allegations in the administrative complaint by clear and convincing evidence. Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987).

   
   

8. Respondent is charged with violating former Rules 21S-1.014 and 21S- 1.023, Florida Administrative Code, and Sections 465.014, 465.015(2)(c), 465.016(1)e) and (n), and 465.023(1)(c), Florida Statutes (1989). The cited rules have now been renumbered as rules 21S-28.109 and 21S-28.112, respectively. However, new rule 21S-28.109 differs in content from old rule 21S-1.014, and thus the old rule is relevant to this proceeding. Accordingly, former rule 21S-

   1.014 and new rule 21S-28.112 will be considered. The former rule provides that:

   
   

   If a community pharmacy is open for business and a Florida registered pharmacist is not present and on duty, the prescription department shall be considered closed . . . the said prescription department shall be separate from the remainder of the community pharmacy . . . and 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 of any community pharmacy.

   Rule 21S-28.112 provides as follows:

   
   

   No person as defined by Section 1.01, Florida Statutes shall own, operate, maintain, open, establish, conduct, or take charge of any pharmacy wherein the sale, possession, or transfer of possession, either with or without prescription, of any medicinal drug is done in violation of the laws of the State of Florida or any federal laws.

   
   

   Also, Section 465.014 authorizes disciplinary action to be taken against a licensee for the following conduct:

   
   

   No person other than a licensed pharmacist or pharmacy intern may engage in the practice of the profession of pharmacy, except that a licensed pharmacist may designate to non- licensed pharmacy technicians those duties, tasks, and functions which do not fall within the purview of s. 465.003(12). All such delegated acts shall be performed under the direct supervision of a licensed pharmacist who shall be responsible for all such acts performed by persons under his supervision.

   No licensed pharmacist shall supervise more than one pharmacy technician unless otherwise permitted by the guidelines adopted by the board. The board shall establish guidelines to be followed by licensees or permittees in determining the circumstances under which a licensed pharmacist may supervise more than

   one but not more than two pharmacy technicians.

   
   

   In addition, subsection 465.015(2)(c) proscribes the following conduct on the part of a licensee:

   
   

   (c) To sell or dispense drugs as defined in s. 465.003(7) without first being furnished with a prescription.

   
   

   Next, subsections 465.016(1)(e) and (n) specify that the following acts shall be grounds for disciplinary action:

   
   

   (e) Violating any of the requirements of this chapter; . . .

   * * *

   (n) Violating a rule of the board or department or violating an order of the board or department previously entered in a disciplinary hearing.

   Finally, subsection 465.023(1)(c) authorizes disciplinary action against a pharmacy permittee if the permittee has:

   
   

   (c) Violated any of the requirements of this chapter or any of the rules of the Board of Pharmacy; . . .

   
   

9. By clear and convincing evidence, petitioner has sustained the charges in Counts I through IV. Therefore, it is concluded that respondent is guilty of all specified charges. Rule 21S-30.001, Florida Administrative Code, sets forth guidelines for imposing penalties on licensees found guilty of violating agency rules or statutory law. For violating a law governing the practice of pharmacy, to wit, allowing a nonlicensed pharmacy technician to dispense a drug and opening a pharmacy without a registered pharmacy being on duty, the rule calls for a penalty ranging from a reprimand and one year probation to a one year suspension. For selling or dispensing non-scheduled drugs without a prescription, the rule calls for a penalty ranging from a letter of guidance to one year suspension while the dispensing of scheduled drugs calls for a penalty ranging from a $1,000 fine and one year probation to revocation of the license. For violating a Board rule (21S-1.014 and 21S-28.112), the recommended penalty ranges from a letter of guidance to one year probation and a $1,000 fine.

Except for the fact that respondent has never been previously disciplined and no apparent harm to the public occurred by virtue of his conduct, there are no mitigating or aggravating circumstances. Given these considerations, a reprimand, one year probation and a $500 administrative fine is an appropriate penalty.

RECOMMENDATION

Based upon the foregoing findings of facts and conclusions of law, it is RECOMMENDED that respondent be found guilty of violating Sections 465.014,

465.015(2)(c), 465.016(1)(e)and (n), and 465.023(1)(c), Florida Statutes (1989), and that he be given a reprimand, fined $500 and his license placed on probation for one year.

DONE and ENTERED this 12th day of March, 1992, in Tallahassee, Florida.

DONALD R. ALEXANDER

Hearing Officer

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, FL 32399-1550

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 12th day of March, 1992.

COPIES FURNISHED:

Tracey S. Hartman, Esquire

1940 North Monroe Street, Suite 60

Tallahassee, FL 32399-0792

Obi E. Enemchukwu

P. O. Box 32

Tavares, FL 32778-0032

Jack L. McRay, Esquire

1940 North Monroe Street, Suite 60

Tallahassee, FL 32399-0792

John Taylor, Executive Director Board of Pharmacy

1940 North Monroe Street Tallahassee, FL 32399-0792

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

ALL PARTIES HAVE THE RIGHT TO SUBMIT WRITTEN EXCEPTIONS TO THIS RECOMMENDED ORDER. ALL AGENCIES ALLOW EACH PARTY AT LEAST 10 DAYS IN WHICH TO SUBMIT WRITTEN EXCEPTIONS. YOU SHOULD CONTACT THE AGENCY THAT WILL ISSUE THE FINAL ORDER IN THIS CASE CONCERNING AGENCY RULES ON THE DEADLINE FOR FILING EXCEPTIONS TO 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: 91-004822

Orders for Case No: 91-004822