STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF ) PHARMACY, )

)

Petitioner, )

)

vs. ) Case No. 00-4310PL

)

MARLENE BASS, R.PH., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a hearing was held in this case in accordance with Section 120.57(1), Florida Statutes, on December 28, 2000, by video teleconference at sites in West Palm Beach and Tallahassee, Florida, before Stuart M. Lerner, a duly-designated Administrative Law Judge of the Division of Administrative Hearings.

APPEARANCES

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

Agency for Health Care Administration 2727 Mahan Drive

Tallahassee, Florida 32308

For Respondent: Marlene Bass, R.Ph., pro se

3000 North Ocean Drive, No. 9G Riviera Beach, Florida 33404

STATEMENT OF THE ISSUES

Whether Respondent committed the violation alleged in the Administrative Complaint, and, if so, what disciplinary action should be taken against her.

PRELIMINARY STATEMENT

On August 23, 2000, Petitioner filed an Administrative Complaint against Respondent, a Florida-licensed pharmacist, alleging that Respondent engaged in the following conduct and thereby violated Section 465.016(1)(g), Florida Statutes:

On June 18, 1998 a prescription was presented to Respondent to be filled for an eighty year old female patient. The prescription called for Thyroid #30, 15 milligrams each. In lieu of that prescribed by the treating physician[,] the Respondent dispensed fifteen (15) pills on June 18, 1998, and fifteen (15) pills on June 29, 1998, each of [which] contained

180 milligram[] dosages of Thyroid.

Through the submission of a completed Election of Rights form dated September 20, 2000, Respondent "dispute[d]

the . . . allegations of fact contained in the Administrative Complaint" and requested "a hearing involving disputed issues of material fact, pursuant to Section 120.569 and 120.57(1), Florida Statutes, before an administrative law judge appointed by the Division of Administrative Hearings." On October 19, 2000, the matter was referred to the Division of Administrative Hearings (Division) for the assignment of a Division Administrative Law Judge to conduct the hearing Respondent had requested.

On December 14, 2000, Petitioner filed a Motion to Relinquish Jurisdiction in the instant case, arguing that there "remain[ed] no disputed issues of material fact." In

its motion, Petitioner conceded that "[a]nother pharmacist separate and apart from the Respondent filled the June 29 prescription [referred to in the Administrative Complaint]." On December 27, 2000, following a motion hearing held by telephone conference call, an Order was issued denying Petitioner's Motion to Relinquish Jurisdiction.

As noted above, the final hearing was held on

December 28, 2000. Three witnesses testified at the hearing: Anthony Lamattina, Respondent, and David Dimon. In addition to the testimony of these three witnesses, one exhibit, Petitioner's Exhibit 1, was offered and received into evidence.

At the close of the evidentiary portion of the hearing, the undersigned established a deadline (15 days from the date of the filing of the hearing transcript with the Division) for the filing of proposed recommended orders.

A transcript of final hearing (consisting of one volume) was filed with the Division on February 19, 2001. Respondent filed a proposed recommended order on January 8, 2001. To date, Petitioner has not filed any post-hearing submittal.

FINDINGS OF FACT

Based upon the evidence adduced at the final hearing and the record as a whole, the following findings of fact are made:

1. Respondent is now, and has been since 1976, a Florida-licensed pharmacist.

2. At all times material to the instant case, Respondent was employed by Eckerd Corporation as one of two full-time pharmacists assigned to the Eckerd Drug Store (Store Number 3372) located at 312 North Lake Boulevard in North Palm Beach, Florida, which housed a community pharmacy that was open 14 hours a day.

3. Respondent and the store's other full-time pharmacist worked separate, alternating shifts.

4. At the beginning of each shift, Respondent "signed on" the pharmacy's computer system. She "logged off" the system at the end of the shift.

5. Respondent was responsible for the supervision of all activities in the pharmacy during her shift.

6. Among the activities it was her responsibility to supervise were those engaged in by the pharmacy technician on duty.

7. The pharmacy technician assisted Respondent by, among other things, preparing computer-generated prescription labels and customer receipts for prescriptions that needed to be filled. The technician prepared these items by entering the required information, including the name and strength of the prescribed medication, into the pharmacy's computer

   system. 1/

   
   

8. All prescription labels and customer receipts prepared by the pharmacy technician on duty during Respondent's shift contained Respondent's initials ("MCB").

9. After they were prepared, the prescription labels and customer receipts were placed in bags, and the bags were put in baskets on the counter near Respondent, where they remained until the prescriptions were filled.

10. When filling a prescription, it was Respondent's practice to examine the actual prescription written by the prescribing physician or, in the case of an oral prescription, the pharmacy's written record of such prescription, to confirm the accuracy of the prescription information on the prescription label and customer receipt and to make sure that she was dispensing what the physician had prescribed. 2/

11. The pharmacy was a "very busy" one. As a result, at the end of her shift, there were sometimes prescriptions for which labels and receipts (bearing her initials) had been prepared, but which Respondent had not had the opportunity to fill, and it was not until the following shift, when she was off duty, that these prescriptions were actually filled.

12. Respondent was on duty on June 18, 1998, when a computer-generated prescription label and customer receipt for a prescription (Prescription Number 6071853) for Patient H. V.

    were prepared. The computer-generated prescription label and customer receipt, which had Respondent's initials on them, indicated, among other things, that the prescription was for

    15 180 milligram tablets of Thyroid and that the prescribing physician was Dr. H. Pomeranz.

13. It is unclear when, and by whom, Prescription Number 6071853 was filled.

14. On or about October 9, 1998, Patient H. V.'s son,

    
    

    R. V., filed a complaint with Petitioner alleging that "the prescription [his mother] was suppose[d] to [have] be[en] taking was 15 mil[li]grams," but she instead "was given 180 mil[lli]grams per day by [the] Eckerd Drug Store [on North Lake Boulevard]."

15. David Dimon, a Medical Malpractice Investigator with the Agency for Health Care Administration, investigated the complaint.

16. As part of his investigation, Mr. Dimon contacted Respondent, who advised him that she did not want to make a statement regarding the complaint.

17. Mr. Dimon also spoke with the prescribing physician, Dr. Pomeranz, who told him that she "prescribed Thyroid, 15 milligrams, for the patient, and not the 180 milligram dose given by Eckerd Pharmacy." 3/ Dr. Pomeranz further indicated

    to Mr. Dimon that H. V. 4/ suffered "side effects" as a result of taking the 180 milligram tablets.

    CONCLUSIONS OF LAW

    
    

18. Petitioner is statutorily empowered to take disciplinary action against Florida-licensed pharmacists based upon any of the grounds enumerated in Section 465.016(1), Florida Statutes. Such disciplinary action may include one or more of the following penalties: license revocation; license suspension; imposition of an administrative fine not to exceed

    $5,000 for each count or separate offense; issuance of a reprimand; and placement on probation for a period of time and subject to such conditions as the Board may specify, including, but not limited to, requiring the licensee to submit to treatment, to attend continuing education courses, to submit to reexamination, or to work under the supervision of another licensee. Section 465.016(2), Florida Statutes.

19. A license that has been suspended or revoked may not be "reinstate[d] . . . until such time as [Petitioner] is satisfied that [the disciplined licensee] has complied with all the terms and conditions set forth in the final order and that the [licensee] is capable of safely engaging in the practice of pharmacy." Section 465.016(3), Florida Statutes.

20. Section 465.016(1)(g), Florida Statutes, authorizes Petitioner to take disciplinary action against a licensed

    pharmacist for "[u]sing in the compounding of a prescription, or furnishing upon prescription, an ingredient or article different in any manner from the ingredient or article prescribed, except as authorized in s. 465.019(6) or s.

    465.025." 5/

    
    

21. "No revocation [or] suspension . . . of any [pharmacist's] license is lawful unless, prior to the entry of a final order, [Petitioner] has served, by personal service or certified mail, an administrative complaint which affords reasonable notice to the licensee of facts or conduct which warrant the intended action and unless the licensee has been given an adequate opportunity to request a proceeding pursuant to ss. 120.569 and 120.57." Section 120.60(5), Florida Statutes.

22. The licensee must be afforded an evidentiary hearing if, upon receiving such written notice, the licensee disputes the alleged facts set forth in the administrative complaint. Sections 120.569(1) and 120.57, Florida Statutes.

23. At the hearing, Petitioner bears the burden of proving that the licensee engaged in the conduct, and thereby committed the violations, alleged in the administrative complaint. Proof greater than a mere preponderance of the evidence must be presented. Clear and convincing evidence of the licensee's guilt is required. See Department of Banking

    and Finance, Division of Securities and Investor Protection v. Osborne Stern and Company, 670 So. 2d 932, 935 (Fla. 1996); Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987); Pou v.

    Department of Insurance and Treasurer, 707 So. 2d 941 (Fla. 3d DCA 1998); and Section 120.57(1)(j), Florida Statutes ("Findings of fact shall be based upon a preponderance of the evidence, except in penal or licensure disciplinary proceedings or except as otherwise provided by

    statute ").

    
    

24. Clear and convincing evidence "requires more proof than a 'preponderance of the evidence' but less than 'beyond and to the exclusion of a reasonable doubt.'" In re Graziano, 696 So. 2d 744, 753 (Fla. 1997). It is an "intermediate standard." Id. For proof to be considered "'clear and convincing' . . . 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." In re Davey, 645 So. 2d 398, 404 (Fla. 1994), quoting, with approval, from Slomowitz v. Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983).

25. In determining whether Petitioner has met its burden of proof, it is necessary to evaluate its evidentiary presentation in light of the specific factual allegations made in the administrative complaint. Due process prohibits an agency from taking disciplinary action against a licensee based upon conduct not specifically alleged in the agency's administrative complaint or other charging instrument. See Hamilton v. Department of Business and Professional Regulation, 764 So. 2d 778 (Fla. 1st DCA 2000); Lusskin v. Agency for Health Care Administration, 731 So. 2d 67, 69 (Fla. 4th DCA 1999); and Cottrill v. Department of Insurance, 685 So. 2d 1371, 1372 (Fla. 1st DCA 1996).

26. Furthermore, "the conduct proved must legally fall within the statute or rule claimed [in the administrative complaint] to have been violated." Delk v. Department of Professional Regulation, 595 So. 2d 966, 967 (Fla. 5th DCA 1992). In deciding whether "the statute or rule claimed to have been violated" was in fact violated, as alleged by Petitioner, if there is any reasonable doubt, that doubt must be resolved in favor of the licensee. See Whitaker v. Department of Insurance and Treasurer, 680 So. 2d 528, 531 (Fla. 1st DCA 1996); Elmariah v. Department of Professional Regulation, Board of Medicine, 574 So. 2d 164, 165 (Fla. 1st DCA 1990); and Lester v. Department of Professional and

    Occupational Regulations, 348 So. 2d 923, 925 (Fla. 1st DCA 1977).

27. Petitioner has alleged in the Administrative Complaint issued in the instant case that Respondent violated Section 465.016(1)(g), Florida Statutes, on June 18, 1998, and again on June 29, 1998, by dispensing 15 180 milligram Thyroid pills, when the prescriptions she was given to fill on those two occasions "called for" 30 15 milligram pills of Thyroid.

28. To meet its burden of proving that Respondent violated Section 465.016(1)(g), Florida Statutes, as alleged in the Administrative Complaint, Petitioner had to clearly and convincingly establish, through its proof at hearing, that Respondent filled the two prescriptions referenced in the Administrative Complaint (which hereinafter will be referred to as the "June 18 prescription" and the "June 29 prescription") and that she did so in a manner that deviated from the requirements of the prescriptions.

29. Petitioner made no attempt, at hearing, to prove that Respondent had misfilled the June 29 prescription, Petitioner having conceded prior to hearing (in its Motion to Relinquish Jurisdiction) that "[a]nother pharmacist separate and apart from the Respondent [had] filled the June 29 prescription."

30. While it did pursue the charge made in the Administrative Complaint concerning the filling of the June 18 prescription, its proof fell short of that necessary to establish Respondent's guilt of the violation charged.

31. To prove that Respondent was the pharmacist that had filled the June 18 prescription, Petitioner presented evidence establishing that Respondent was one of the pharmacists on duty at Eckerd Drug Store Number 3372 on June 18, 1998, and that her initials were on the label and customer receipt that the store's computer system had generated for the prescription that day. Such evidence, however, does not clearly and convincingly establish that it was Respondent (as opposed to the pharmacist who worked the following shift) who filled the June 18 prescription. See Nelms v. Walgreen Co., 1999 WL 462145 (Tenn. App. 1999)("Plaintiff argues that, from this evidence, a jury could have inferred that Walgreen Company's representatives engaged in fraudulent conduct in an attempt to conceal the fact that a pharmacy technician, and not Daniel [the pharmacist whose initials were on the prescription label], filled Inez Nelms' prescription. We conclude that this argument is without merit. Although a jury could have found from the foregoing evidence that Ed Daniel was not the pharmacist who filled Inez Nelms' prescription, such a finding would not necessarily lead to the inference that a pharmacy

    technician rather than a pharmacist filled the prescription. Steve Presson, the pharmacist who was scheduled to work from 1:00 p.m. to 10:00 p.m. on October 2, 1995, testified that either he or Daniel was the pharmacist on duty when the prescription was filled. Thus, the Plaintiff's proof presented two equally probable scenarios: that a pharmacy technician filled the prescription in Ed Daniel's absence and, alternatively, that Steve Presson filled the prescription.

    Inasmuch as the proof failed to establish that one of these conclusions was more probable than the other, we hold that this proof cannot constitute clear and convincing evidence that Walgreen Company's representatives fraudulently concealed the fact that a pharmacy technician filled Inez Nelms' prescription."). Indeed, Petitioner's own witness, Anthony Lamattina, an Eckerd Corporation pharmacist who testified as to the standard operating procedures followed in Eckerd Drug Stores, was unable, with any degree of confidence, to conclude, based upon the presence of Respondent's initials on the computer-generated label and customer receipt for the June

    18 prescription, that the prescription had been filled by Respondent. 6/

32. Not only did Petitioner fail to prove that it was Respondent who had filled the June 18 prescription, Petitioner also failed to prove that the prescription had been misfilled.

    To show that the prescription had been misfilled, it was necessary for Petitioner, as a threshold requirement, to establish, by clear and convincing evidence, what the prescription actually "called for." The only proof it submitted concerning the actual contents of the prescription was the testimony of Mr. Dimon concerning what Dr. Pomeranz had told him about the prescription. Petitioner did not offer the prescription into evidence, nor did it present the testimony of Dr. Pomeranz. Mr. Dimon's testimony constitutes hearsay evidence 7/ that would not be admissible over objection in a civil proceeding in Florida, and it therefore, standing alone, is insufficient to support a finding concerning the contents of the June 18 prescription. See Department of Environmental Protection v. Department of Management Services, Division of Administrative Hearings, 667 So. 2d 369, 370 (Fla. 1st DCA 1995); Sublett v. Sumter County School Board, 664 So. 2d 1178 (Fla. 5th DCA 1995); Doyle v.

    Florida Unemployment Appeals Commission, 635 So. 2d 1028,

    
    

    (Fla. 2d DCA 1994); Scott v. Department of Professional Regulation, 603 So. 2d 519 (Fla. 1st DCA 1992); Forehand v. School Board of Gulf County, 600 So. 2d 1187, 1191-92 (Fla. 1st DCA 1992); Department of Administration, Division of Retirement v. Porter, 591 So. 2d 1108, 1109 (Fla. 2d DCA 1992); Doran v. Department of Health and Rehabilitative

    Services, 558 So. 2d 87, 88 (Fla. 1st DCA 1990); Johnson v. Department of Health and Rehabilitative Services, 546 So. 2d 741 (Fla. 1st DCA 1989); and Section 120.57(1)(c), Florida Statutes ("Hearsay evidence may be used for the purpose of supplementing or explaining other evidence, but it shall not be sufficient in itself to support a finding unless it would be admissible over objection in civil actions."); see also Keefover v. Giant Food, Inc., 574 A.2d 339 (Md. App.

    1990)("Judge Levin, in sustaining objections by Giant, said: 'I am not going to let you get in any evidence as of right now of anything that Dr. Ein prescribed for this lady [Ms.

    Keefover, the plaintiff in this action involving the alleged negligent filling of a prescription]. It's that simple.' We believe the trial court was correct. The statements allegedly made by Dr. Ein are clearly hearsay insofar as Keefover's claim against Giant is concerned.").

33. Inasmuch as the record evidence does not clearly and convincingly establish that Respondent misfilled either the June 18 prescription or the June 29 prescription, the Administrative Complaint issued against Respondent, which alleges that she engaged in such professional misconduct, must be dismissed.

    RECOMMENDATION

    
    

    Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby

    RECOMMENDED that the Board enter a final order dismissing the Administrative Complaint issued against Respondent in its entirety.

    DONE AND ENTERED this 13th day of March, 2001, in Tallahassee, Leon County, Florida.

    ___________________________________ STUART M. LERNER

    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 13th day of March, 2001.

    
    

    ENDNOTES

    
    

    1/ Rule 64B16-27.410, Florida Administrative Code, authorizes the use of pharmacy technicians in community pharmacies. It provides as follows:

    
    

    Pharmacy technicians may assist a Florida licensed pharmacist in performing professional services within a community pharmacy or institutional pharmacy environment provided that no licensed pharmacist shall supervise more than one pharmacy technician unless otherwise permitted by the Florida Board of Pharmacy. A pharmacist's supervision of a pharmacy technician in a 1:1 ratio working

    environment requires that a pharmacy technician be under the direct and immediate personal supervision of a Florida licensed pharmacist. All pharmacy technicians shall identify themselves as pharmacy technicians by wearing a type of identification badge that is clearly visible which specifically identifies the employee by name and by status as a "pharmacy technician", and in the context of telephone or other forms of communication, pharmacy technicians shall state their names and verbally identify themselves (or otherwise communicate their identities) as pharmacy technicians.

    Pursuant to the direction of the licensed

    pharmacist, pharmacy technicians may engage in the following functions to assist the licensed pharmacist:

    
    

    1. Prepackaging and labeling of unit and multiple dose packages pursuant to appropriate procedures. The pharmacist shall directly supervise and conduct in- process and final checks, and affix his/her initials to the record. Such pharmacy technician activities would include the maintenance of control records;

       
       

    2. Assist the pharmacist in the preparation of the prescription. Such pharmacy technician functions include the typing of prescription labels on a typewriter or through entry into a computer system and the entry of prescription information or physicians' orders into a computer system. The pharmacist, however, must complete the dispensing act and initial the prescription;

       
       

    3. Assist in the preparation of products in a pharmacy where such products are not directly dispensed and administered to the patient and when done pursuant to appropriate procedures under the direct and immediate supervision of a pharmacist who shall conduct in-process and final checks;

    4. Issue supplies and other products from an institutional pharmacy to physicians, nursing homes, and other departments in institutions, pursuant to appropriate procedures;

       
       

    5. Initiate a phone call to a prescribing practitioner or their medical staffs (or agents) regarding patient prescription refill authorization requests. Such pharmacy technician activities allow initiating calls to the practitioner or agent, communicating the refill request and confirming the patient's name, medication, strength, quantity, directions and date of last refill. Any response to the above refill request that indicates a change in the order must be directly received by the pharmacist and/or pharmacy intern.

       
       

       2/ All such original prescriptions filled at Eckerd Corporation pharmacies are retained for a period of seven years. (Rule 64B16-28.140(1)(d), Florida Administrative Code, requires that "[a]ll original prescriptions . . . be retained for a period of not less than two years from the date of last filing.")

       
       

       3/ This "out-of-court" statement made by Dr. Pomeranz (who did not testify at the final hearing) is the only record evidence supporting the allegation made in the Administrative Complaint that Prescription Number 6071853 (a copy of which was not offered into evidence at the final hearing) "called for" 15 milligram, not 180 milligram, tablets of Thyroid.

       
       

       4/ H. V., like Dr. Pomeranz, did not testify at the final hearing.

       
       

       5/ Sections 465.019(6) and 465.025, Florida Statutes, provide as follows:

       
       

       465.019 Institutional pharmacies; permits.-- . . . .

       
       

    6. In a Class II institutional pharmacy, an institutional formulary system may be adopted with approval of the medical staff for the purpose of identifying those medicinal drugs and proprietary

preparations that may be dispensed by the pharmacists employed in such institution. A facility with a Class II institutional permit which is operating under the formulary system shall establish policies and procedures for the development of the system in accordance with the joint standards of the American Hospital Association and American Society of Hospital Pharmacists for the utilization of a hospital formulary system, which formulary shall be approved by the medical staff.

465.025 Substitution of drugs.--

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 her or 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).

(b) 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.

   
   

2. Each community pharmacy shall establish a formulary of generic and brand name drug products which, if selected as the drug product of choice, would not pose a threat to the health and safety of patients receiving prescription medication. In compiling the list of generic and brand name drug products for inclusion in the formulary, the pharmacist shall rely on drug product research, testing, information, and formularies compiled by other pharmacies, by states, by the United States Department of Health, Education, and Welfare, by the United States Department of Health and Human Services, or by any other source which the pharmacist deems reliable. Each community pharmacy shall make such formulary available to the public, the Board of Pharmacy, or any physician requesting same. This formulary shall be

   revised following each addition, deletion, or modification of said formulary.

   
   

3. The Board of Pharmacy and the Board of Medicine shall establish by rule a formulary of generic drug type and brand name drug products which are determined by the boards to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, would pose a threat to the health and safety of patients receiving prescription medication.

   
   

   1. The formulary may be added to or deleted from as the Board of Pharmacy and the Board of Medicine deem appropriate. Any person who requests any inclusion, addition, or deletion of a generic drug type or brand name drug product to the

      formulary shall have the burden of proof to show cause why such inclusion, addition, or deletion should be made.

      
      

   2. Upon adoption of the formulary required by this subsection, and upon each addition, deletion, or modification to the formulary, the Board of Pharmacy shall mail a copy to each manager of the prescription department of each community pharmacy licensed by the state, each nonresident pharmacy registered in the state, and each board regulating practitioners licensed by the laws of the state to prescribe drugs shall incorporate such formulary into its rules. No pharmacist shall substitute a generically equivalent drug product for a prescribed brand name drug product if the brand name drug product or the generic drug type drug product is included in the said formulary.

      
      

4. Every community pharmacy shall display in a prominent place that is in clear and unobstructed public view, at or near the place where prescriptions are dispensed, a sign in block letters not less than 1 inch in height which shall read: "CONSULT YOUR

   PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF FLORIDA LAW."

   
   

5. The standard of care to be applied to the acts of any pharmacist performing professional services in compliance with this section when a substitution is made by said pharmacist shall be that which would apply to the performance of professional services in the dispensing of a prescription order prescribing a drug by generic name. In no event when a pharmacist substitutes a drug shall the prescriber be liable in any action for loss, damage, injury, or death to any person occasioned by or arising from the use or nonuse of the substituted drug, unless the original drug was incorrectly prescribed.

6/ Mr. Lamattina gave the following testimony on the subject: CROSS-EXAMINATION

BY MS. BASS: . . . .

Q. So it's possible that, while my initials are on that prescription, somebody else could have filled that prescription [the June 18 prescription]?

A. Very possible.

MS. BASS: That's all the questions I have.

REDIRECT EXAMINATION BY MR. KRANERT:

Q. How would that have happened?

A. You come in the middle of the day, and someone else has been filling -- another pharmacist is in charge, but has a backlog of prescription labels in baskets.

You're given a basket, it has the label in the basket, sometimes it has the drug. You read the -- and the prescription, you read the prescription, you read the label, you put together the prescription, and out it goes.

It does have the other pharmacist's, who is in the computer at the time, initials on the label.

Q. Now as described to you, this particular label does not have another pharmacist's initial[s] on the label?

A. No it doesn't.

Q. It -- it has Ms. Bass' initial[s] on the label?

A. That's correct.

Q. So Ms. Bass and/or her technician for this original prescription was responsible for not only the filling, but the verification of the completed product before it was delivered to the patient.

A. I can't say that, because some other pharmacist may have come in and filled it, even though this was in a basket to be filled . . . -- I can't tell you that she filled the prescription. . . .

RE-CROSS-EXAMINATION BY MS. BASS:

Q. But it is possible that the pharmacist who actually filled that prescription could be somebody other than M[C]B; is that not correct?

A. The pharmacist who actually counted the pills, labeled it --

Q. Did -- did --

A. -- looked at the original prescription if it was there, could be someone else, yes.

MS. BASS: That's it.

FURTHER REDIRECT EXAMINATION BY MR. KRANERT:

Q. Why would their labels not appear -- their initials not appear on the label?

A. Because when the label was typed they were not in the computer. . . .

FURTHER CROSS-EXAMINATION BY MS. BASS:

Q. But that pharmacist that filled that prescription does not -- would not necessarily have been the name on the label?

A. That is correct.

Q. Is it not true that you come in some days and there are baskets sky high --

A. Correct.

Q. -- and they have somebody else's initials on them?

A. That's correct.

Q. And you fill them and send them on their way.

A. That's correct.

Q. So the prescription -- the -- the pharmacist's name on the label is not yours?

A. The initials printed by the computer don't necessarily have to be mine, even though I filled the prescription, and that -- . . . .

7/ "'Hearsay' is a statement, other than one made by the declarant while testifying at the trial or hearing, offered in evidence to prove the truth of the matter asserted." Section 90.801(1)(c), Florida Statutes.

COPIES FURNISHED:

Lawrence F. Kranert, Jr., Esquire Agency for Health Care Administration Fort Knox Building

2727 Mahan Drive

Tallahassee, Florida 32308

Marlene Bass, R.Ph.

3000 North Ocean Drive, No. 9G Riviera Beach, Florida 33404

John Taylor, R.Ph., Executive Director Board of Pharmacy

Department of Health 4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

Theodore M. Henderson, Agency Clerk Department of Health

4052 Bald Cypress Way Bin A00

Tallahassee, Florida 32399-1701

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: 00-004310PL

Orders for Case No: 00-004310PL