STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF ) PHARMACY, )

)

Petitioner, )

)

vs. )

) GUY HENDRICKS, III, R.PH., )

)

Respondent. )

Case No. 00-4311PL

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative Hearings, by its duly-designated Administrative Law Judge, Jeff B. Clark, held a formal hearing in this case on

December 18, 2000, by video teleconference, between Orlando and

Tallahassee, Florida.

APPEARANCES

For Petitioner: Guy Hendericks, III

Post Office Box 4173 Sebring, Florida 33871

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

Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 32317-4229 STATEMENT OF THE ISSUE

Whether Respondent, Guy Hendricks, III, R.Ph., is subject to discipline pursuant to Subsection 465.016(1)(e), Florida

Statutes, for violating Rule 64B16-28.120(2), Florida

Administrative Code.

PRELIMINARY STATEMENT

During an Annual Survey conducted by the Agency for Health Care Administration (AHCA) on August 28-29, 1996, at the Arbors in Orange Park, the nursing home was cited for the alleged inappropriate use of a SureMed Dispensing Machine. Respondent, Guy R. Hendricks, III, R.Ph., was notified by letter from AHCA dated July 9, 1997, that "there is a pending investigation regarding your license to practice" based on "the alleged improper use of an automated dispensing machine." Respondent had became the "consulting pharmacist" at the Arbors in Orange Park shortly before the August 1996 AHCA survey.

On October 19, 2000, the Division of Administrative Hearings (DOAH) received an Amended Administrative Complaint alleging that Respondent had violated Subsection 465.016(1)(e), Florida Statutes. This statute lists acts which are grounds for disciplinary actions against a pharmacist's license. Respondent had disputed the allegations and petitioned for a hearing.

On November 17, 2000, a Notice of Hearing was entered setting the case for final hearing on December 18, 2000, in Orlando, Florida. This notice was amended on December 14, 2000, setting the matter for hearing by video teleconference on

December 18, 2000; Respondent appeared in Orlando, and Petitioner and Administrative Law Judge in Tallahassee, Florida.

Petitioner presented three witnesses: Respondent; Franklin E. May, R.Ph., employed by AHCA; and Kathy Redfearn, a AHCA investigator. Petitioner offered five exhibits, all of which were received in evidence. Respondent elected not to testify in his case but presented an unsworn closing argument. The Transcript of the proceedings was filed on February 26, 2001. Neither party submitted proposed recommended orders.

FINDINGS OF FACT

Based on the oral and documentary evidence presented at the final hearing, the following findings of facts are made:

1. Respondent, Guy R. Hendricks, III, R.Ph., is a Florida-licensed registered pharmacist, so licensed in 1972; he was licensed as a consultant pharmacist in 1974.

2. Registered pharmacists typically dispense medications at a community pharmacy, for example, Eckerds and Walgreen's. Consulting pharmacists oversee a pharmaceutical distribution system in a long-term care nursing home facility with a Class I institutional permit.

3. In addition to his employment at the Arbors in Orange Park (the Arbors), Respondent is engaged in the development of "cutting edge consultant computer programs" and "research and development in the field of software platforms which will lead

   to a fully integrated consultant software package." (Respondent's vita, Petitioner's Exhibit 2)

4. On August 1, 1996, Respondent became the consulting pharmacist for the Arbors. The AHCA survey, which is the genesis of the allegations of the Amended Administrative Complaint in this case, was conducted later that same month.

5. The Arbors is a sub-acute care facility which has a Class I institutional pharmacy permit. Florida Statutes and Florida Administrative Code rules restrict the type of medicinal drugs and drug preparations allowed in Class I institutional pharmacies.

6. One of the consulting pharmacist's responsibilities is to see that the applicable Florida Statutes and Florida Administrative Code rules are followed within the Class I institutional pharmacies, subject to pharmacist's control.

7. The Arbors utilized a Baxter SureMed Dispensing Machine (SureMed machine) which is a computerized dispensing machine that stores medications and allows the pharmacist to track when medications are taken from the machine, by whom they are taken, what dosage is dispensed, and to whom the medication is administered. It has a complete computerized tracking system. It is a "modern tool of pharmacy" used to provide a high level of pharmaceutical care for nursing home residents.

8. Florida Statutes and Florida Administrative Code rules require that nursing homes, such as the Arbors, provide "reasonable and consistent quality of life for residents" and that "reasonable efforts be made to accommodate the needs and preferences of residents to enhance the quality of life in a nursing home."

9. Florida Administrative Code rules allow the Arbors to adopt policies and procedures regarding drugs to meet the needs of residents and to maintain an Emergency Medical Kit(s), the contents of which shall be determined by the facility's medical director, director of nursing, and pharmacist, and "it (the medical kit) shall be in accordance with facility policy and procedures"; the "emergency medical kit" may contain medicinal drugs and drug preparations which are not otherwise allowed within Class I institutional pharmacies. Respondent testified that the SureMed machine was being used as one of the Emergency Medical Kits of the Arbors.

10. The drugs contained in the SureMed machine were determined by the Arbors staff before Respondent was employed as consulting pharmacist.

11. During the August 27-28, 1996, AHCA Survey, the surveyor concluded that the SureMed machine was being used inappropriately by the Arbors. The survey revealed that the

    SureMed dispensing unit was used as an emergency medication kit. Review of the SureMed Policy and Procedure stated "Medications stored in SureMed are intended for emergency stat orders, late admission first dose, new orders and missing doses" (part of Petitioner's Exhibit 5) contrary to the approved use of medicinal drugs used in facilities with a Class I Institutional Pharmacy Permit. An inventory list provided by the facility revealed in excess of 300 medications in the SureMed unit and this unit had been accessed 22 times in the 24 hours prior to surveyor review. Further review of the usage log revealed that an unsampled resident received Norixin from the SureMed unit on 8/26/96 at 23:04, 8/27/96 at 22:21 and 8/28/96 at 22:21 instead of receiving a resident specific labeled medication from the provider pharmacy.

    
    

12. Respondent suggests that a "typographical error" may have occurred in the facility's SureMed policy and procedure in that, if the word "not" is inserted after the words "emergency stat orders," the policy and procedure would conform to the limitations proscribed for Class I institutional permitees. While this explanation is plausible, it is not accepted as credible. This portion of the Arbors' SureMed policy and procedure, referenced by the AHCA surveyor, does not follow Florida law.

13. If the foregoing policy and procedure language is the only language considered, the surveyor's conclusions may be justified; however, the surveyor failed to note the following language which immediately follows the quote from the same

    SureMed policy and procedure. "SureMed is not intended to be a routine source of medication. The pharmacy must be informed of all new admissions, new orders, refill orders, and missing doses."

14. When a nursing home resident is first admitted to the Arbors, the admittee does not bring medications but brings new prescription orders which must be filled by the provider or back-up pharmacy.

15. Home Care Pharmacy in Orlando, Florida, provides medications to the Arbors; it is 140 miles from Orlando to Orange Park. Deliveries are made two times a day. There were occasions in 1996 when patients were out of medication or Home Care Pharmacy was not delivering as ordered.

16. While the Arbors has only a Class I institutional permit which limits drugs readily available to residents, the facility accepts residents who are "sub-acute" care patients, for example, patients with chronic disease, post-surgical patients, and patients with "super" infections, all of whom require continuity of pharmaceutical therapy.

17. Frank May, a registered pharmacist and certified HCFA surveyor for AHCA, testified that while the Arbors' SureMed policy and procedure were "out of compliance," nevertheless, it was appropriate to "take a drug out of the machine or out of the emergency medication kit if it cannot be provided by the

    provider pharmacy or if that provider pharmacy is a long way off or by a back-up pharmacy in a timely manner for the next dosage of that medication."

18. May also testified that "there is nothing wrong" with utilizing the SureMed machine as an emergency medical kit or maintaining drugs, otherwise not permitted in a Class I institution permit, in the machine.

19. May further testified that without examining each instance wherein the SureMed machine was accessed immediately prior to the AHCA survey, it would be impossible to determine whether or not an "emergency" existed warranting the use of the particular drug obtained from the SureMed machine.

20. May testified that in 1996, the use of automated drug dispensing machines was becoming very prominent in nursing homes; and problems, such as addressed in this case, were "fairly prevalent."

21. Respondent maintains that the facility's use of the SureMed machine was on a bona fide emergency basis only.

22. The Arbors' SureMed policy and procedure were changed immediately following the August 1996 survey.

23. Respondent sent AHCA a July 20, 1997, letter in response to the AHCA licensure investigation in which he identified the SureMed machine as a "computerized emergency system," a "modern tool of pharmacy," and "our only

    solution" "to treat our residents' sub acute conditions" when "some local pharmacies . . . could not provide medications."

24. The SureMed machine was removed from the Arbors in November 1996.

    CONCLUSIONS OF LAW

    
    

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

26. The Department of Health is a state agency charged with regulating the practice of pharmacy pursuant to Section 20.43, Florida Statutes, and Chapters 455 and 465, Florida Statutes.

27. The Department of Health is authorized to take disciplinary action against pharmacists based upon the grounds stated in Section 465.016, Florida Statutes.

28. The Amended Administrative Complaint alleges that Respondent violated Chapter 465, Florida Statutes, in that he violated Rule 64B16-28.120(2), Florida Administrative Code, which provides that

    (2) All medicinal drugs or drug preparations as defined in

    Section 465.003(7), F.S., within Class I Institutional permittees as defined by Section 465.019(2)(a) shall have been dispensed pursuant to a prescription as defined in Section 465.003(13), F.S. All medicinal drugs or drug preparations as defined in Section 465.003(7), F.S., shall

    be prohibited within the confines of Class I Institutional pharmacies unless obtained upon a proper prescription and properly labeled in accordance with Chapter 499, Florida Statutes, and the rules and regulations contained in Chapter 59A-4, F.A.C., pertaining to the licensure of nursing homes and related facilities.

    
    

29. In a licensure discipline proceeding of this nature 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.

    
    

30. 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 licensee." Elmariah v. Department of Professional

    
    

    Regulation, 574 So. 2d 164, 165 (Fla. 1st DCA 1990).

    
    

31. Rule 59A-4.112, Florida Administrative Code, Pharmacy Services, states, in pertinent part, that

    1. The facility shall adopt procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals, to meet the needs of each resident.

       
       

       * * *

       
       

       (10) The facility shall maintain an Emergency Medication Kit, the contents of which shall be determined in consultation with the Medical Director, Director of Nursing and Pharmacist, and it shall be in accordance with facility policies and procedures. The kit shall be readily available and shall be kept sealed. All items in the kit shall be properly labeled. The facility shall maintain an accurate log of receipt and disposition of each item in the Emergency Medication Kit. An inventory of the contents of the Emergency Medication Kit shall be attached to the outside of the kit. If the seal is broken, the kit must be resealed the next business day after use.

       
       

32. After he became the consulting pharmacist at the Arbors on August 1, 1996, Respondent became responsible to assure that the facility's use of the SureMed machine complied with Florida law.

33. Florida law does not limit the type or amount of medicinal drugs or drug preparations which can be maintained in an Emergency Medication Kit in a nursing home facility.

34. The text of the Arbors' SureMed policy and procedure did not comply with Florida law in that the policy and procedure suggest accessing the SureMed machine on a non-emergency basis.

35. While the activity related to the SureMed machine immediately prior to the AHCA survey suggests inappropriate use of the SureMed machine, no clear and convincing evidence is presented that the machine was accessed on a non-emergency basis.

RECOMMENDATION

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

RECOMMENDED that the charges against Respondent in the Amended Administrative Complaint be dismissed.

DONE AND ENTERED this 28th day of March, 2001, in Tallahassee, Leon County, Florida.

JEFF B. CLARK

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 28th day of March, 2001.

COPIES FURNISHED:

Guy Hendericks, III Post Office Box 4173 Sebring, Florida 33871

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

Tallahassee, Florida 32317-4229

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 A02 Tallahassee, Florida 32399-1701

William W. Large, General Counsel Department of Health

4052 Bald Cypress Way, Bin A02 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: 00-004311PL

Orders for Case No: 00-004311PL