00-004311PL Department Of Health, Board Of Pharmacy vs. Guy Hendricks, Iii, R.Ph. Status: Closed Recommended Order on Wednesday, March 28, 2001.

Summary: Consulting pharmacist charged with improper use of automated drug dispensing machine; recommend charges in Amended Administrative Complaint be dismissed.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

PHARMACY, )

)

Petitioner, )

)

vs. ) Case No. 00-4311PL

)

GUY HENDRICKS, III, R.PH ., )

)

Respondent. )

)

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 nu rsing 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 i nstitutional

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 als o 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 mach ine 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 Hea lth 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 agenc ies 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 consultin g 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 [phone]

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.