vs. )
Respondent. )
Case No. 00-4115PL
Administrative Law Judge ("ALJ") Daniel Manry conducted the administrative hearing of this proceeding on January 4, 2001, in Naples, Florida.
For Petitioner: Ephraim D. Livingston, Esquire
For Respondent: Bruce M. Stanley, Sr., Esquire
The ultimate issues for determination are whether Respondent violated Section 458.331(1)(f) and (w), Florida Statutes (2000), by allowing or directing a nurse to fill out two separate written prescriptions for Keflex and Vicodin and to sign Respondent's name and the nurse's initials on each
prescription; and, if so, what penalty, if any, should be imposed against Respondent's license to practice medicine. (All chapter and section references are to Florida Statutes (2000) unless otherwise stated.)
On June 26, 2000, Petitioner filed an Administrative Complaint against Respondent. Respondent timely requested an administrative hearing.
At the hearing, Petitioner presented the testimony of one witness and submitted six exhibits for admission in evidence. Respondent testified in his own behalf, presented the live testimony of one witness, and submitted as Respondent's only exhibit the deposition testimony of a plastic surgeon that Petitioner originally designated as its expert but did not call at the hearing ("Petitioner's expert"). The identity of the witnesses and exhibits and any attendant rulings are set forth in the Transcript of the hearing filed on January 23, 2001.
Respondent timely submitted his Proposed Recommended Order ("PRO") on January 26, 2001. Petitioner timely submitted its PRO on February 8, 2001.
Petitioner is the state agency responsible for regulating the practice of medicine in Florida pursuant to Sections 20.165 and 20.43 and Chapters 455 and 458. Respondent
is licensed as a medical physician in Florida pursuant to license number ME0054804.
Respondent has been a board-certified plastic surgeon since 1992. After graduating from the University of Virginia Medical School in 1983, Respondent completed a three-year residency in general surgery at the University of Alabama, a two-year residency in plastic surgery at the University of Tennessee, and a one-year fellowship in breast reconstructive surgery at Vanderbilt University. Respondent completed his fellowship at Vanderbilt University in 1989 and began the private practice of medicine in the same year as a plastic surgeon in West Palm Beach, Florida.
In 1997, Respondent moved to Naples, Florida, and joined the practice of Dr. Richard Maloney. Dr. Maloney operates a freestanding facility for plastic surgery known as the Aesthetic Surgery Center (the "Center"). Dr. Maloney has exclusive authority over the daily operation and policy of the Center. Respondent has authority over the medical care of Respondent's individual patients.
On or about July 8, 1998, Ms. Deborah Puhl, LPN, was a nurse at the Center. Nurse Puhl completed two written prescriptions for patient C.R. and signed Respondent's name to each prescription. Nurse Puhl wrote her initials beside the signature of Respondent's name on each prescription.
One of the written prescriptions was a prescription for Keflex 500 mg. The other written prescription was for Vicodin
7.5 mg. Keflex is an antibiotic. Vicodin is the brand name for hydrocodone bitartrate. Hydrocodone bitartrate is an opiod analgesic similar to codeine and a controlled substance within the meaning of Chapter 893.
When C.R. presented the two prescriptions to a pharmacist on duty at a local K-Mart, the pharmacist filled the written prescription for Keflex but correctly determined that the pharmacist has no legal authority to fill a written prescription for a controlled substance unless the prescription is signed by the physician. The pharmacist never filled the written prescription for Vicodin that was signed by Nurse Puhl.
The pharmacist telephoned the Center and verified the written prescription for Vicodin with a nurse at the Center. Once verified by telephone, the Pharmacist determined that there was a valid verbal prescription for Vicodin, and the pharmacist filled the verbal prescription for Vicodin.
The pharmacy then filed a complaint with Petitioner complaining of the procedure at the Center that allowed nurses to sign written prescriptions for a controlled substance. Petitioner investigated the complaint and determined there was probable cause to bring this action.
By letter dated October 28, 1998, Petitioner notified the Center that it was illegal for nurses to sign written prescriptions. Dr. Maloney immediately terminated the office procedure. Neither Dr. Maloney, Nurse Puhl, nor Respondent had actual knowledge prior to the letter from Petitioner that a pharmacist has no legal authority to fill a written prescription for a controlled substance unless the prescription is signed by the prescribing practitioner.
Petitioner argues in this case that Respondent violated an express provision in Section 893.04(1)(b). Petitioner construes the requirement in Section 893.04(1)(b) for a physician to sign a written prescription for a controlled substance as being enforceable against the physician. For reasons discussed more fully in the Conclusions of Law, Petitioner's statutory construction of Section 893.04(1)(b) may be misplaced. Even if Petitioner's statutory construction of Section 893.04(1)(b) were correct, Petitioner did not charge in the Administrative Complaint that Respondent violated Section 893.04(1)(b). Petitioner expressly limited the Administrative Complaint to allegations that Respondent violated Section 458.331(1)(f) and (w).
Petitioner cited no legal authority at the hearing or in its PRO that authorizes Petitioner to prove that Respondent is guilty of charges that are not alleged in the Administrative
Complaint. For reasons stated more fully in the Conclusions of Law, such a procedure would clearly violate fundamental principles of due process, deprive Respondent of adequate notice of the charges against him, and deprive Respondent of a fair opportunity to prepare a defense to allegations not included in the Administrative Complaint. Thus, matters relevant to the allegation that Respondent violated Section 893.04(1)(b) are beyond the scope of the Administrative Complaint and irrelevant to the allegations in the Administrative Complaint that Respondent violated Section 458.331(1)(f) and (w).
Section 458.331(1)(f) and (w) contains no express requirement for written prescriptions to be signed a physician or prescribing practitioner. In relevant part, Section 458.331(1) prohibits a physician from:
(f) Aiding, assisting, procuring, or advising any unlicensed person to practice medicine contrary to this chapter or to a rule of the department or board. (emphasis supplied)
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(w) Delegating professional responsibilities to a person when the licensee delegating such responsibilities knows or has reason to know that such person is not qualified by training, experience, or licensure to perform them.
Petitioner cited no provision in Chapter 458 or in any rule promulgated pursuant to Chapter 458 that expressly makes
the signature of a nurse on a written prescription a violation of either Section 458.331(f) or (w). A determination of whether a nurse's signature on a written prescription violates either Section 458.331(f) or (w), or both, must be made based on all of the surrounding facts and circumstances established by clear and convincing evidence.
Nurse Puhl's signature on the written prescription for Keflex did not violate either Section 458.331(1)(f) or (w).
The procedure used for the Keflex prescription involved neither the practice of medicine nor the performance of any professional responsibilities by an unqualified person. In response to questions about a nurse calling in a prescription for Keflex, Respondent's expert explained:
. . . I would say, [Nurse] Penny, would you please call in a prescription for Keflex
500 milligrams 14, directions take one twice a day and start the day before surgery
. . . .
Q. . . . you are not delegating to her any medical judgment? . . . .
A. I'm simply using her as an extended agent of myself for the patient's benefit.
Respondent's Exhibit 1, at 24-25.
The substance of the testimony of the pharmacist called as a witness by Petitioner was consistent with the testimony of Petitioner's expert. The pharmacist determined
that he was authorized to fill a written prescription for Keflex that was signed by a nurse.
The signature of Nurse Puhl on the written prescription for Vicodin involved neither the practice of medicine nor the performance of any professional responsibilities within the meaning of Section 458.331(1)(f) or (w). Respondent did not delegate to Nurse Puhl any medical discretion concerning the care of Respondent's patient. Nor did Respondent aid, assist, procure, or advise Nurse Puhl in the exercise of any medical discretion or similar professional responsibility concerning the care of Respondent's patient. Respondent alone determined the type of medication, dosage, administration, strength, and other particulars of the prescription for Vicodin. Nurse Puhl merely acted as an "extended agent" or scribe for Respondent.
The testimony of Respondent's expert elucidates the issue of whether a nurse practices medicine or performs professional responsibilities when she effectuates a physician's orders. Respondent's expert explained, in relevant part:
Q. And you don't give your nurse the option of what kind of medication to prescribe or the dosage or how often it should be taken, do you?
A. . . . here's where the rub is, if there is anything to do with narcotics . . ., it's been my understanding that I need to write a prescription for it. And in fact when I've
called to the pharmacy, for example, for Percocet, I have been told by the pharmacist that I cannot prescribe this over the phone and that there has to be a written prescription from me for the patient.
That's the pharmacists that are here and that has been my experience here. . . .
(emphasis supplied)
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. . . with anything that I'm asking my nurse to do, it's something that I've thought through that is my responsibility that I have asked her simply as a convenience to take care of as an agent for me, as a go- between for me that I'm not asking her to think about.
Respondent's Exhibit 1, at 25-26.
The prescriptions for Keflex and Vicodin were part of the routine standing orders in place at the Center. They were written on preprinted prescription forms. There was no opportunity for Nurse Puhl to change either prescription.
Respondent did not direct or allow Nurse Puhl to sign his name to the written prescriptions for Keflex and Vicodin. Nurse Puhl signed Respondent's name to the written prescriptions pursuant to the direction of Dr. Maloney. Dr. Maloney had exclusive authority to direct matters concerning office procedure. The signature of written prescriptions by nurses was part of the office procedure at the Center and within the sole and exclusive authority of Dr. Maloney. The signature of written prescriptions was not a matter of patient care over which Respondent had exclusive authority.
The signature of Nurse Puhl on the written prescription for Vicodin caused no harm to the public. The pharmacist did not fill the written prescription. The amount of Vicodin prescribed in both the written and verbal prescriptions was a reasonable post-surgical prescription for pain. Pain management is part of all medical practices, including plastic surgery. Petitioner has no prior disciplinary history.
CONCLUSION OF LAW
The Division of Administrative Hearings has jurisdiction over the parties and the subject matter. The parties received adequate notice of the administrative hearing. Section 120.57(1).
The burden of proof is on Petitioner. Petitioner must show by clear and convincing evidence that Respondent committed the violations alleged in Administrative Complaint and the reasonableness of any proposed penalty. 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); State ex rel. Vining v. Florida Real Estate Commission, 281 So. 2d 487 (Fla. 1973).
Petitioner did not satisfy its burden of proof. The reasons that Petitioner did not satisfy its burden of proof involve both legal and evidentiary deficiencies.
The legal deficiency arises from the interplay between Sections 893.04(1)(b) and 458.331(1)(f) and (w).
Section 893.04(1)(b) authorizes a pharmacist to "dispense" controlled substances only if the pharmacist has a written prescription that is signed by the prescribing practitioner. Section 893.13(7)(b) subjects any person who "distributes" a controlled substance in violation of Chapter 893 to criminal prosecution for a first degree misdemeanor that is punishable by up to one-year imprisonment as provided in Section 775.082(4)(a).
Neither Petitioner nor the undersigned sitting in place of the agency head has jurisdiction to enforce criminal statutes. However, Section 893.09(1) and (2) authorizes Petitioner to undertake an administrative action to enforce Section 893.04(1)(b).
Petitioner cited no legal authority to support a conclusion that Petitioner can enforce Section 893.04(1)(b) against a physician. In relevant part, Section 893.04 provides:
A pharmacist . . . may dispense controlled substances upon a written or oral prescription of a practitioner, under the following conditions: (emphasis supplied)
Oral prescriptions must be promptly reduced to writing by the pharmacist. (emphasis supplied)
The written prescription must be dated and signed by the prescribing practitioner on the day when issued.
The terms "dispense" and "distribute" are defined separately in Section 893.02(6) and (7). Neither definition expressly includes the writing of a prescription by a physician. Assuming arguendo that writing a prescription is a method of dispensing a controlled substance, nothing in Section 893.04 prescribes the conditions upon which a physician is authorized to "dispense" a controlled substance by written prescription. The plain and ordinary meaning of the terms of Section 893.04 prescribes conditions upon which a pharmacist is authorized to dispense a controlled substance by filling a presription. If a pharmacist dispenses a controlled substance based on a written prescription that is not signed by a physician, the enforcement action authorized in Section 893.09(1) and (2) is an administrative action against the pharmacist who violated Section 893.04(1)(b).
In support of its administrative action against Respondent, who is a physician, Petitioner relies on the provision in Section 893.04(1)(b) that prescribes the conditions upon which a pharmacist is authorized to dispense a controlled substance pursuant to a written prescription by a physician. Petitioner relies on a silent premise that if a pharmacist dispenses a controlled substance in violation of Section
893.04(1)(b), Petitioner may undertake an administrative action against the physician pursuant to Sections 893.04(1)(b) and 893.09(1) and (2). Petitioner cited no legal authority in support of its silent premise.
Petitioner did not allege in the Administrative Complaint that Respondent violated Section 893.04(1)(b). Petitioner limited the Administrative Complaint to allegations that Respondent violated Section 458.331(1)(f) and (w).
Petitioner argues that Respondent's alleged violation of Section 458.331(1)(f) and (w) is evidenced by the express provision in Section 893.04(1)(b) that authorizes a pharmacist to dispense a controlled substance only if the pharmacist has a written prescription signed by a physician. Unlike Section 893.04(1)(b), however, Section 458.331(1)(f) and (w) does not contain an express provision that authorizes a physician to prescribe a controlled substance only if the physician signs a written prescription. The two statutes are not synonymous and notice in the Administrative Complaint that Petitioner charged Respondent with violating Section 458.331(1)(f) and (w) is not adequate notice that provides a fair opportunity for Respondent to prepare a defense to the charge that Respondent violated Section 893.04(1)(b).
Petitioner cannot effectively amend Section 458.331(1)(f) and (w) to include the express provision found in
Section 893.04(1)(b) that authorizes a pharmacist to dispense a controlled substance only if a written prescription is signed by a physician. A statute such as Section 458.331(1)(f) and (w) that imposes a penalty is never to be construed in a manner that expands the statute. Hotel and Restaurant Commission v. Sunny
Seas No. One, 104 So. 2d 570, 571 (Fla. 1958.) Disciplinary statutes such as Section 458.331(1)(f) and (w) are penal in nature and must be strictly interpreted against the authorization of discipline and in favor of the person sought to be penalized. Munch v. Department of Business and Professional Regulation, 592 So. 2d 1136, 1143 (Fla. 1st DCA 1992); Fleischman v. Department of Business and Professional Regulation, 441 So. 2d 1121, 1133 (Fla. 3rd DCA 1983.); Lester
v. Department of Professional and Occupational Regulations, State Board of Medical Examiners, 348 So. 2d 923 (Fla. 1st. DCA 1977).
In the absence of an express requirement in Section 458.331(1)(f) and (w) for Respondent to sign a written prescription, the evidentiary issue for determination is whether the failure of Respondent to sign a written prescription aided, assisted, procured, or advised an unlicensed person to practice medicine or delegated professional responsibilities to an unqualified person within the meaning of Section 458.331(1)(f) or (w). Petitioner must prove each element required in the
statutory definition of the violation by clear and convincing evidence.
In order for evidence to be clear and convincing:
The evidence must be of such weight that it produces in the mind of the trier of fact a firm . . . conviction, without hesitancy, as to the truth of the allegations sought to be established.
Slomowitz v. Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983).
Petitioner's evidence consists of six exhibits and the testimony of the pharmacist who filled a verbal prescription for a controlled substance and who is the complaining witness against Respondent. The deposition testimony of Petitioner's expert is evidence submitted by Respondent.
The six exhibits submitted by Petitioner are the certified licensure file of Respondent, the curriculum vitae of Petitioner's expert witness, copies of the prescriptions for Keflex and Vicodin, a statement of the costs of investigation and prosecution up to the date of hearing, the investigative report of Petitioner, and the curriculum vitae of the pharmacist. None of Petitioner's exhibits are probative of the issue of whether the failure of Respondent to sign a written prescription aided, assisted, procured, or advised an unlicensed person to practice medicine or delegated professional responsibilities to an unqualified person within the meaning of Section 458.331(1)(f) or (w).
Part of the testimony of Petitioner's expert is legally irrelevant because it addresses the failure of Respondent to sign a written prescription for a controlled substance in the context of Section 893.04(1)(b). However, another part of the testimony of Petitioner's expert is relevant and material to the issue of whether the failure of Respondent to sign a written prescription aided, assisted, procured, or advised an unlicensed person to practice medicine or delegated professional responsibilities to an unqualified person within the meaning of Section 458.331(1)(f) or (w). The relevant part of the testimony of Petitioner's expert concludes that when a nurse carries out the orders of a physician, the physician does not delegate the practice of medicine or delegate professional responsibilities to an unqualified person. See, e.g., Respondent's Exhibit 1, at 23-26.
The deposition testimony of Respondent's expert and the testimony of the pharmacist at the hearing conflict over the authority of a pharmacist to fill a verbal prescription for Vicodin. Respondent's expert testified that pharmacists could not fill a verbal prescription for a controlled substance. The pharmacist testified that the verbal prescription for Vicodin was filled because the verbal prescription was a valid prescription. The pharmacist's testimony is consistent with the express terms of Section 893.04(1)(a) that authorizes a
pharmacist to fill an oral prescription for a controlled substance if the pharmacist immediately reduces the prescription to writing. Compare Respondent's Exhibit 1, at 25-26, and Section 893.04(1)(a) with Transcript at 52, line 18, through 55, line 22.
The remaining portion of the testimony of the pharmacist called as witness by Petitioner attempted to render an opinion as to whether a nurse's signature on a written prescription constituted the practice of medicine or the performance of professional responsibilities by an unqualified person within the meaning of Section 458.331(1)(f) and (w). However, a pharmacist is not qualified by education or experience to render an opinion regarding the practice of plastic surgery, including the writing of prescriptions for medication.
Even if a pharmacist were qualified to render an expert opinion regarding the practice of plastic surgery, the pharmacist in this case is an employee or agent of the complaining witness (the pharmacy) and, therefore, is an interested witness in this case. The testimony of one interested witness does not begin to approach the level of competent and substantial evidence. Robinson v. Florida Board of Dentistry, Department of Professional Regulation, Division of Professions, 447 So. 2d 930, 932 (Fla. 3d DCA 1984).
The evidence submitted by Respondent was credible and persuasive and sufficient to refute the evidence submitted by Petitioner. The evidence of record was clear and convincing that Respondent did not violate Section 458.331(1)(f) or (w).
RECOMMENDED that Petitioner enter a Final Order finding that Respondent is not guilty of violating Section 458.331(1)(f) and (w) and dismissing the Administrative Complaint.
Ephraim D. Livingston, Esquire
Bruce M. Stanley, Esquire Henderson, Franklin, Starnes & Holt Post Office Box 280
William W. Large, General Counsel Department of Health
Theodore M. Henderson, Agency Clerk Department of Health
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.
