STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )

)

Petitioner, )

)

vs. ) CASE NO. 92-4270

) NAN-DAN, INC., d/b/a BUY RITE ) DRUG and d/b/a PROFESSIONAL RX ) SYSTEMS, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice to all parties, a formal hearing was conducted in this case at West Palm Beach, Florida, on January 6, 1993, before Michael M. Parrish, a duly designated Hearing Officer of the Division of Administrative Hearings.

Appearances for the parties at the hearing were as follows:

APPEARANCES

For Petitioner: Wayne H. Mitchell, Esquire

Department of Professional Regulation Northwood Centre, Suite 60

1940 North Monroe Street Tallahassee, Florida 32399-0792

For Respondent: William M. Furlow, Esquire

Katz, Kutter, Haigler, Alderman, Davis & Marks, P.A.

Post Office Box 1877 Tallahassee, Florida 32302-1877

STATEMENT OF THE ISSUES

This is a license discipline case, in which the Petitioner seeks to take disciplinary action against a pharmacy licensee on the basis of alleged violations of Sections 465.014, 465.023(1)(c), and 465.025(3)(b), Florida Statutes.

PRELIMINARY STATEMENT

Shortly prior to the formal hearing in this case the Petitioner filed a Motion For Leave To Amend/Correct Petitioner's Administrative Complaint and accompanied the motion with a Second Amended Administrative Complaint. Argument on the motion was heard on the morning of the formal hearing. The motion was granted and the Petitioner was permitted to substitute the Second Amended Administrative Complaint for the prior administrative complaints in this case.

At the formal hearing the Petitioner presented the testimony of five witnesses and offered three exhibits. Petitioner's exhibits 2 and 3 were received in evidence; Petitioner's exhibit 1 was not. The Respondent offered the testimony of one witness. The Respondent did not offer any exhibits.

At the conclusion of the hearing, the parties were allowed 20 days from the filing of the transcript within which to file their proposed recommended orders. A transcript of the proceedings was filed with the Hearing Officer on February 15, 1993. Thereafter, all parties filed timely proposed recommended orders containing proposed findings of fact and conclusions of law. The parties' proposals have been carefully considered during the preparation of this Recommended Order. Specific rulings on all findings of fact proposed by the parties are contained in the appendix hereto.

FINDINGS OF FACT

1. The Respondent in this case, Nan-Dan, Inc., is, and has been at all times material to the Second Amended Administrative Complaint, a licensed community pharmacy, holding license number PH 0002807. The Respondent does business as "Buy-Rite Drugs." The Respondent's address is 103 South 3rd Street, Lantana, Florida 33462-2853. The Respondent Nan-Dan, Inc., does not do business as "Professional Rx Systems."

   
   

2. There is another business entity known as "Professional Rx Systems," which was licensed in November of 1987, and which does business as "Nan-Dan Corp., Inc." Professional Rx Systems is a licensed community pharmacy, having been issued license number PH 0010094. Professional Rx Systems is a separate and distinct licensee and is a separate and distinct business entity from Nan- Dan, Inc., the Respondent in this case.

   
   

3. On or about May 30, 1991, a pharmacy (probably Professional Rx Systems) prepared a billing statement regarding prescriptions for patient O.I. The entries on the billing statement include an entry for prescription number 6171144, described as "60 ROBAXIN-750 TABS," with a corresponding charge of

   $33.42. The second page of the May 30, 1991, billing statement includes an entry for prescription number 4173954, described as "30 DARVOCET N 100," with a corresponding charge of $20.02.

   
   

4. Robaxin 750 and Darvocet N-100 are both brand name drugs.

   
   

5. Dr. Faustino Gonzalez was and is the Medical Director of Gold Star Medical Management, a company which subcontracts with Humana Medical Plans to provide medical services to a group of patients. The facilities at which Gold Star Medical Management provides medical services probably includes Eason Nursing Home. In any event, in approximately May of 1991, Gold Star Medical Management did a quality review for Eason Nursing Home, in which it looked at the prescriptions for numerous patients. Of the cases that were reviewed, Dr. Gonzalez did not recall seeing anything but generic drugs which had been actually dispensed to the patients. However, Dr. Gonzalez does not recall whether the Robaxin 750 listed on the billing statement described above was one of the drugs he reviewed. Similarly, there is no evidence that the Darvocet N-

   100 listed on the billing statement described above was one of the drugs reviewed by Gold Star Medical Management.

   
   

6. Dr. Gonzalez did not recall whether he had ever actually seen patient

   O.I. and he did not know whether the drugs actually furnished to patient O.I. were brand name drugs or generic drugs.

7. There is no evidence in the record of this case of the identity of the pharmacist or pharmacists who may have dispensed any drugs to patient O.I. There is no evidence in the record of this case as to the amount of the cost savings, if any, that accrued or might have accrued to the pharmacy if generic drugs had been dispensed in lieu of brand name drugs. There is no evidence in the record of this case as to how much was paid by or on behalf of the patient

   O.I. for the drugs itemized on the billing statement described above.

   
   

8. For a brief period during July of 1987, the Respondent employed Harold

   B. Steinberg as a pharmacist. Mr. Steinberg presently has a hostile attitude towards the owner of the Respondent corporation.

   
   

9. From approximately February of 1991 through May of 1991, Joyce Trapp was employed by the Respondent as a pharmacy technician.

   
   

   CONCLUSIONS OF LAW

   
   

10. The Division of Administrative Hearings has jurisdiction over the subject matter of and the parties to this proceeding. Sec. 120.57(1), Fla. Stat.

    
    

11. In a license discipline proceeding of this nature the Petitioner bears the burden of proving its charges by clear and convincing evidence. See Ferris

    v. Turlington, 510 So.2d 292 (Fla. 1987). The nature of clear and convincing evidence has been described as follows in Slomowitz v. Walker, 429 So.2d 797, 800 (Fla. 4th DCA 1983):

    
    

    We therefore hold that clear and convincing evidence requires that the evidence must be found to be credible; the facts to which the witnesses testify must be distinctly remembered; the testimony must be precise and explicit and the witnesses must be lacking in confusion as to the facts in issue. The evidence must be of such weight that it produces in the mind of the trier of fact a firm belief or conviction, without hesitancy, as to the truth of the allegations sought to be established.

    
    

    See also, Smith v. Department of Health and Rehabilitative Services, 522 So.2d 956 (Fla. 1st DCA 1988), which, at page 958, quotes with approval the above- quoted language from Slomowitz. The Smith case also includes the following at page 958:

    
    

    "Clear and convincing evidence" is an intermediate standard of proof, more than the "preponderance of the evidence" standard used in most civil cases, and less than the "beyond a reasonable doubt" standard used in criminal cases. See State v. Graham, 240 So.2d 486 (Fla. 2d DCA 1970).

    
    

12. Although agencies generally have wide discretion in interpreting the statutes they are charged with administering, such discretion is more limited when the statute in question authorizes disciplinary action against a professional license. Statutes authorizing agencies to suspend or revoke

    professional licenses are considered to be penal in nature and, therefore, "must be strictly construed, with any ambiguity interpreted in favor of the licensee." Elmariah v. Department of Professional Regulation, 574 So.2d 164, 165 (Fla. 1st DCA 1990).

    
    

13. Count I of the Second Amended Administrative Complaint charges the Respondent with a violation of Section 465.025(3)(b), Florida Statutes, and goes on to assert that such a violation makes the Respondent subject to discipline as provided by Section 465.023(1)(c), Florida Statutes. Section 465.025, Florida Statutes (1989), reads as follows, in pertinent part:

    
    

    1. As used in this section:

       1. "Brand name" means the registered trademark name given to a drug product by its manufacturer, labeler, or distributor.

       2. "Generically equivalent drug product" means a drug product with the same active ingredient, finished dosage form, and strength.

       3. "Prescriber" means any practitioner licensed to prescribe medicinal drugs.

    2. A pharmacist who receives a prescription for a brand name drug shall, unless requested otherwise by the purchaser, substitute a less expensive, generically equivalent drug

       product that is:

       1. Distributed by a business entity doing business, and subject to suit and service of legal process, in the United States; and

       2. Listed in the formulary of generic and brand name drug products as provided in subsection (5) for the brand name drug prescribed, unless the prescriber writes

          the words "MEDICALLY NECESSARY," in his own handwriting, on the face of a written prescription or unless, in the case of an oral prescription, the prescriber expressly indicates to the pharmacist that the brand name drug prescribed is medically necessary.

          (3)(a) Any pharmacist who substitutes any drug as provided in subsection (2) shall notify the person presenting the prescription of such substitution, together with the existence and amount of the retail price difference between the brand name drug and the drug substituted for it, and shall inform the person presenting the prescription that such person may refuse the substitution as provided in subsection (2).

          1. Any pharmacist substituting a less expensive drug product shall pass on to the consumer the full amount of the savings realized by such substitution.

             1. Each pharmacist shall maintain a record of any substitution of a generically equivalent drug product for a prescribed brand name drug as provided in this section.

14. Section 465.023(1)(c), Florida Statutes (1989), reads as follows, in pertinent part:

    
    

    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. . . .

       
       

15. With respect to Petitioner's evidence in support of Count I, there was insufficient evidence presented to raise even an inference that the Respondent violated Section 465.025(3)(b), Florida Statutes, as charged in the Second Amended Administrative Complaint. First, it was never clearly established that the Respondent issued the billing statements or dispensed the drugs in question (if it is possible for a pharmacy, as opposed to a "pharmacist," to dispense drugs). And because there was no evidence offered to show that dispensing the generic drugs resulted in, or should have resulted in, a cost savings to the pharmacy, there is no way to determine whether there were any cost savings which were not passsed along to the consumer if the Respondent did, in fact, dispense a generic drug and bill for a brand name drug. Further, even if it had been established that a pharmacist employed by the Respondent pharmacy dispensed a generic drug to a patient, but billed for a more expensive brand name drug, the Petitioner still could not prevail on the allegations in Count I of the Second Amended Administrative Complaint without establishing that the consumer paid, or at least was billed for, an amount greater than the regular price of the brand name drug, less the generic drug substitution cost savings to the pharmacist. For all of the foregoing reasons, Count I of the Second Amended Administrative Complaint should be dismissed.

    
    

16. Count II of the Second Amended Administrative Complaint charges the Respondent with a violation of Section 465.014, Florida Statutes, and goes on to assert that such a violation makes the Respondent subject to discipline as provided by Section 465.023(1)(c), Florida Statutes. Section 465.014, Florida Statutes (1986 Supp.), reads as follows:

    
    

    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 delegate to nonlicensed 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.

    
    

17. The following statutory definition at Sections 465.003(5) and (12), Florida Statutes (1986 Supp.), are also relevant to the disposition of Count II:

    
    

    1. "Dispense" means the transfer of possession of one or more doses of a medicinal drug by a pharmacist or other licensed practitioner to the ultimate consumer thereof or to one who represents that it is his intention not to consume or use the same but to transfer the same to the ultimate consumer or user for consumption by the ultimate consumer or user. The actual sales transaction and delivery of such drug shall not be considered dispensing. The administration, as hereinafter defined, in a health care institution of medical drugs to a patient, or the administration of medicinal drugs by a physician to his patient, shall

    not be considered dispensing.

    
    

    (12) "Practice of the profession of pharmacy" includes compounding, dispensing, and consulting concerning contents, therapeutic values, and uses of any medicinal drug and consulting concerning therapeutic values and interactions of patent or proprietary preparations, whether pursuant to prescriptions or in the absence and entirely independent of such prescriptions or orders. The phrase also includes any other act, service, operation, or transaction incidental to, or forming a part of, any of the foregoing acts, requiring, involving, or employing the science or art of any branch of the pharmaceutical profession, study, or training.

    
    

18. The essential factual allegations of Count II are that "pharmacy technicians employed by the Respondent (Buy-Rite) were observed to be dispensing medicinal drugs to nursing homes without the supervision of a Florida registered pharmacist." These essential allegations were not proved by clear and convincing evidence. Quite to the contrary, the evidence on this issue was vague, incomplete, and unpersuasive. In this regard it is also noted that the obvious hostility of the witness Harold Steinberg seriously undermined whatever credibility he might otherwise have had. In light of the insufficiency of the evidence to establish the essential allegations of Count II by clear and convincing evidence, Count II of the Second Amended Administrative Complaint should be dismissed.

RECOMMENDATION

On the basis of all of the foregoing, it is RECOMMENDED that the Board of Pharmacy enter a Final Order in this case dismissing all of the violations alleged in the Second Amended Administrative Complaint.

DONE AND ENTERED this 25th day of August, 1993, at Tallahassee, Leon County, Florida.

MICHAEL M. PARRISH

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 25th day of August, 1993.

APPENDIX TO RECOMMENDED ORDER, CASE NO.92-4270

The following are my specific rulings on all proposed findings of fact submitted by all parties.

Findings submitted by Petitioner:

Paragraph 1: Rejected as contrary to the greater weight of the evidence. (See Petitioner's Exhibit 2.)

Paragraph 2: Rejected as not supported by clear and convincing evidence. The only witness to testify on this matter only referred to Eason as one of the nuring homes "being taken care of by Mr. Erb's operation." Mr. Erb has two operations, only one of which is a respondent here. Further, the witness' lack of reliable information on the matter is revealed by his testimony that he ". .

. never got to see the papers." As a final matter, the Hearing Officer has given very little credit to Mr. Steinberg's testimony. Mr. Steinberg's testimony was vague and imprecise and Mr. Steinberg appeared to have very hostile feelings towards the owner of the Respondent entity.

Paragraph 3: Accepted.

Paragraph 4: Rejected as not supported by persuasive clear and convincing evidence. Mr. Steinberg's testimony on this subject was vague and imprecise.

It also has some unexplained conflicting details, among them the assertion at one point that Steinberg was the only pharmacist on the premises and the later assertion that Mr. Erb was present and that Mr. Erb was also a pharmacist.

Further, the only evidence of the absence of supervision consists of hearsay evidence that would not be admissible over objection in a civil action, largely because the hearsay speakers are unidentified. And as a final matter, the activities vaguely described by Mr. Steinberg do not constitute "dispensing" within the statutory definition of the word "dispense" at Section 465.003(5), Florida Statutes (1986 Supp.).

Paragraph 5: Rejected as irrelevant or as subordinate and unnecessary details.

Paragraph 6: Accepted.

Paragraph 7: Rejected as irrelevant because not charged in the Second Amended Administrative Complaint. Also rejected as not supported by persuasive clear and convincing evidence. Ms. Trapp appeared to have a very poor memory and her testimony tended to be vague and incomplete.

Paragraph 8: Rejected for several reasons, including the fact that without a reference to the time and place of these proposed facts, there is no way to determine whether these proposed facts are relevant to the allegations of the Second Amended Administrative Complaint. Also rejected because there is no persuasive clear and convincing evidence of these proposed facts.

Paragraphs 9, 10, 11 and 12: Accepted in substance.

Paragraph 13: Rejected as either not supported by persuasive clear and convincing evidence or as being contrary to the greater weight of the evidence. In this regard it is noted that, although Petitioner's Ex. 3 is incomplete at the top, the visible portion of the business name at the top of the statement is "X SYSTEMS" and printed across the bottom of the statement is the business name "PROFESSIONAL RX SYSTEMS." Accordingly, it is more likely that the drugs billed to patient O.I. were billed by Professional Rx Systems (which is not a Respondent in this case) than that they were billed by the Respondent, Nan-Dan, Inc., d/b/a Buy Rite Drugs. Further, Dr. Gonzalez' testimony was to the effect that he was not sure whether his review included the drugs allegedly furnished to patient O.I.

Paragraphs 14 and 15: Rejected as not supported by persuasive competent substantial evidence. As noted above, any dispensing involving the patient O.I. was probably done by someone other than the Respondent and, in any event, there is no persuasive competent substantial evidence as to what was actually dispensed.

Paragraph 16: Accepted.

Paragraph 17: Rejected as not supported by persuasive competent substantial evidence or as contrary to the greater weight of the evidence. (See discussion of Paragraphs 13, 14, and 15, above.)

Paragraph 18: Accepted that the mentioned drug is a brand name "medicinal drug." The remainder of this paragraph is rejected as irrelevant, as well as not supported by persuasive competent substantial evidence.

Paragraph 19: Rejected as not supported by persuasive competent substantial evidence.

Findings submitted by Respondent:

Paragraphs 1 and 2: Accepted.

Paragraphs 3, 4, 5, and 6: Accepted in substance.

Paragraph 7: Accepted.

Paragraphs 8, 9, 10, 11, 12, and 13: Accepted in substance.

Paragraphs 14 and 14: The last two paragraphs (both of which are numbered as 14) of the Respondent's proposed findings are, for the most part, rejected as constituting arguments as to why findings should not be made, rather than proposed findings of fact. (It is noted that the arguments are, essentially, correct and have been considered in deciding what findings should be made.)

COPIES FURNISHED:

Wayne H. Mitchell, Esquire Department of Business and

Professional Regulation Northwood Centre, Suite 60 1940 North Monroe Street

Tallahassee, Florida 32399-0792

William M. Furlow, Esquire

Katz, Kutter, Haigler, Alderman, Davis & Marks, P.A.

Post Office Box 1877 Tallahassee, Florida 32302-1877

Jack McRay, General Counsel Department of Business and

Professional Regulation 1940 North Monroe Street

Tallahassee, Florida 32399-0792

John Taylor, Executive Director Board of Pharmacy

1940 North Monroe Street Tallahassee, Florida 32399-0775

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. Some agencies allow a larger period within 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: 92-004270

Orders for Case No: 92-004270