STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF PROFESSIONAL )
REGULATION, )
)
Petitioner, )
)
vs. ) CASE NO. 89-6093
)
JESSE ALEXANDER, N.D., )
)
Respondent. )
)
RECOMMENDED ORDER
Pursuant to notice, the above-styled matter was heard before the Division of Administrative Hearings by its duly designated Hearing Officer, Daniel M. Kilbride, on May 29, 1990, in Melbourne, and on May 30, 1990, in Orlando, Florida. The following appearances were entered:
APPEARANCES
For Petitioner: Bruce D. Lamb, Esquire
Chief Trial Attorney Department of Professional Regulation
Suite 201
730 South Sterling Street Tampa, Florida
For Respondent: Steven J. Jacovitz, Esquire
43 South Atlantic Avenue Cocoa Beach, Florida
STATEMENT OF THE ISSUES
Whether Respondent is guilty of violation Section 462.14(1)(q), Florida Statutes, by prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the naturopathic physician's professional practice.
Whether Respondent is guilty of violating Section 462.14.(1)(n), Florida Statutes, by failing to keep written medical records justifying the course of treatment of the patient, S.N.
Whether Respondent is guilty of violating Section 462.14(1)(h), Florida Statutes, by failing to perform a statutory or legal obligation placed upon a licensed naturopathic physician, by prescribing a controlled substance to patient S.N. not done in good faith or not done in the course of Respondent's professional practice.
Whether Respondent is guilty of gross or repeated malpractice or failed to practice naturopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being appropriate under similar conditions and circumstances, in violation of Section 462.14(1)(t), Florida Statutes.
Whether Respondent is guilty of exercising undue influence on the patient or client, S.N., in such a manner as to exploit the patient or client for the financial gain of the licensee, in violation of Section 462.14(1)(o), Florida Statutes.
Whether Respondent is guilty of gross or repeated malpractice or failed to practice naturopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being appropriate under similar conditions and circumstances, concerning patients M.C.P., J.S. and M.A. for the following reasons:
failure to perform an adequate physical examination or order appropriate tests;
failure to adequately monitor the patient;
failure to properly supervises the staff of MIWC; and,
prescribing legend drugs inappropriately, in violation of Section 462.14(1)(t), Florida Statutes.
Whether Respondent is guilty of violating Section 462.14(1)(n), Florida Statutes by failing to keep written medical records justifying the course of treatment of the patients, M.C.P., J.S. and M.A.
Whether Respondent is guilty of violating Section 462.14(1)(q), Florida Statutes, by prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, to patients M.C.P.,
and M.A. other than in the course of the naturopathic physician's professional practice.
Whether Respondent is guilty of violating Section 462.14(1)(w), Florida Statutes, by delegating professional responsibilities to a person when the licensee delegating such responsibilities knows or has reason to know that such a person is not qualified by training, experience, or licensure to perform them.
Whether Respondent is guilty of violating Section 462.14(1)(h), Florida Statutes, by allowing the dispensing of drugs not under his direct supervision. Whether Respondent is guilty of violating Section 462.14(1) (h), Florida Statutes, by failure to properly label medical drugs dispensed at the Island Weight Clinic (hereinafter, WIWC)
Whether Respondent is guilty of violating Section 462.14(1)(h), Florida Statutes, by failure to make a complete and accurate inventory of all controlled substances on a biannual basis.
Whether Respondent is guilty of violating Section 462.14(1) (1), Florida Statutes, by making deceptive, untrue, or fraudulent representations in the practice of naturopathic medicine by claiming the substance HCG is an effective adjunctive therapy in the treatment of obesity.
PRELIMINARY STATEMENT
On July 28, 1987, Petitioner filed an Administrative Complaint against the Respondent in Department Case Nos. 0083804 and 0083805. On September 20, 1989, the Department filed an Amended Administrative Complaint incorporating additional allegations. Respondent denied the allegations and requested a formal hearing before the Division of Administrative Hearings on October 4, 1989. Following a motion to amend, Petitioner was permitted, by order, to amend its complaint by filing a Second Amended Administrative Complaint on December 8, 1989. Following discovery and various motions hearing, this matter proceeded to formal hearing on the allegations contained in the Second Amended Administrative Complaint.
At the hearing, the Petitioner presented the testimony of eleven witnesses and sixteen exhibits were admitted in evidence, in addition five exhibits were offered but not admitted. Respondent offered the testimony of one witness and testified under oath. He offered no exhibits in evidence. The Hearing Officer reserved ruling on two objections which were briefed separately by the parties and are discussed below. The Respondent requested fifteen days to file proposed recommended orders. Petitioner did not object and the request was granted. The transcript was filed with the Clerk of the Division on June 29f 1990.
Petitioner filed its Proposed Recommended Order and Memorandum of Law on July 13, 1990. Respondent filed his July 20, 1990. Each parties' proposals have been carefully considered and are incorporated in this Recommended Order where appropriate. My specific rulings on each party's proposed findings of fact are set out in the appendix attached hereto.
Respondent objected to the admission of the Petitioner's witness's, Flo- Nita Spanogle, testimony relating to the interview of Respondent at the Department's offices in Orlando in 1986 and the interview of Respondent at his apartment in Maitland, Florida and the signed statement, dated September 23, 1988. Ruling on the objection was reserved and the parties filed memoranda of law at the time of the filing of the proposed recommended orders. After review of the memoranda, it is determined that the Respondent is entitled to exercise the privilege against self-incrimination during professional disciplinary investigations conducted by the Department if the refusal to testify is based on a reasonable fear of criminal prosecution. See: Boedy vs. Department of Professional Regulation, 463 So.2d 215 (Fla. 1985), State ex rel Vining vs.
Florida Real Estate Commission, 281 So.2d 487 (Fla. 1973). However, under the facts set forth in Findings of Fact, paragraph 3, Respondent was never subjected to custodial interrogation and therefore there was no requirement to recite Miranda warnings to Respondent. Therefore, the statements made by Respondent during noncustodial interrogations are admissible regardless of the interviewer's subjective intent to elicit culpable statements. State of Florida v. Gonzalez, 467 So.2d 723 (Fla. 1985).
Respondent objected that Petitioner's expert witnesses, Stanley L. Weiss, D.O., and Jeffrey E. Ehrlich, M.D., were not competent to testify and give an opinion on the standard of care and proper course of treatment for Respondent's weight control clinic patients since neither doctor was a licensed naturopathic physician. Both doctors were qualified as an expert in the field of weight control and weight reduction. Neither doctor had special knowledge or training in the field of naturopathic healing and therefore do not qualify as an expert in every aspect of that field. Naturopaths are trained in the homeopathic school of practice, while medical doctors are allopathic physicians and osteopaths are trained similarly. They are not of the same discipline or school of practice as naturopaths. Sections 90.702 and 768.045(2)(c), now Sec.
766.102(2)(c), Florida Statutes (1989); Van Sickle v. Allstate Insurance Company, 503 So.2d 1288 (Fla. 5th DCA 1987). However, expert physicians of different disciplines are not excluded from testifying when that testimony bears on a point as to which the principles of the schools do or should concur.
Ashburn v. Fox, 233 So.2d 840 (Fla. 3d DCA 1970). In applying this principle to the case before this tribunal, the schools must concur on the minimum standard of care for the dispensing of medicinal or legend drugs to patients and of weight control or weight loss. Both Drs. Weiss and Ehrlich meet the requirement of possessing the training, experience or knowledge to testify on the standard of care in those fields. Chenoweth v. Kemp, 396 So.2d 1122 (Fla. 1981)
Based upon all of the evidence, the following findings of fact are determined:
FINDINGS OF FACT
Department of Professional Regulation is the state agency governing the practice of Naturopathy in the State of Florida. Section 462.01(1), Florida Statutes.
Respondent Jesse L. Alexander, N.D., is and has been at all times material to the allegations in the Second Amended Administrative Complaint, licensed to practice naturopathy in the State of Florida, having been issued license number NA 0000515.
During the course of its investigation in 1986 agents of Petitioner inspected Respondent's facilities at the Merritt Island Weight Clinic (MIWC) and the Island Weight Clinic (IWC). Following the inspection, Flo-Nita Spanogle, DPR inspector, telephoned Respondent, advised him of the investigation, requested that he come to her office for an interview. Respondent was advised that he was not required to speak to the investigator. Respondent traveled to the Petitioner's offices in Orlando, Florida and answered questions posed by the investigator. A subsequent interview was conducted at Respondent's residence in Maitland, Florida, where Respondent hand wrote a statement which was notarized by Ms. Spanogle and dated September 23, 1988.
FINDINGS OF FACT CONCERNING S. N.
Beginning on or about January 3, 1986, and continuing through April 19, 1988, Respondent prescribed the following legend drugs for S.N.:
01/03/86 | 60 | Calphosan Inj. 60 ml |
01/06/86 | 20 | Duricef 500 mg. caps. |
01/13/86 | 25 | Provera 2.5 mg. Tablets |
02/17/86 | 12 | Percocet Tablets |
06/16/86 | 40 | Provera 2.5 mg. Tablets |
07/02/86 | 30 | Ben/Mycostatin Oral |
07/02/86 | 100 Phenobarbital 30 mg. | |
07/02/86 | 10 | Macrodantin 50 mg. caps. |
07/02/86 | 12 | Vasotec Tablets 10 mg. |
09/01/86 | 30 | Nitrodisc 5 mg. |
12/07/86 | 30 | Nitrodisc 5 mg. |
12/19/86 | 20 | Cardizem 60 mg. Tablets |
01/23/87 | 12 | Vasotec Tablets 10 mg. |
06/12/87 | 250 Acidophilus with Pectin | |
06/15/87 | 60 | Padma 28 500 mg. Tablets |
09/08/87 | 90 | Maxepa 1000 mg./MARI |
11/11/87 120 Tussi-Organidin Dm.
12/12/87 4 Metronidazole 500 mg.
02/03/88 120 Paregoric Tincture
02/16/88 6 Anaprox 275 mg. Tablets
2/24/88 480 Donnatal Elixir
04/15/88 100 Xanax 1 mg. Tablets
04/19/88 100 Phenobarbital 30 mg.
04/19/88 100 Quinaglute 324 mg. Tablets
04/19/88 100 Ponstel 250 mg. caps.
Respondent stated that S.N. was his neighbor, not his patient; and he prescribed medication to S.N. because she was in severe pain, and was too ill to travel to her regular physician, Dr. Hoult, whose offices were in Fort Lauderdale. The unrebutted testimony of Respondent was that when he first prescribed medicine for her he advised S. N. not to drink alcohol when taking medication.
Respondent's prescribing medication to S.N. was inappropriate and in excessive and inappropriate quantities.
Respondent prescribed legend drugs to S.N., including controlled substances, other than in the course of the naturopathic physician's professional practice.
The Respondent prescribed legend drugs over a period of more than two years and failed to create any medical records for S.N., who was in fact a patient, except for an incomplete list of drugs prescribed; and, therefore, has failed to maintain medical records justifying the course of treatment of patient S.N.
Percocet is the brand name of tablets containing oxycodone hydrochloride and is a Schedule II controlled substance as defined by Subsection 893.03(2), Florida Statutes.
Phenobarbital is a Schedule IV controlled substance as defined by Subsection 893.03(4), Florida Statutes.
Paregoric Tincture is a substance containing opium alkaloids and is a Schedule III controlled substance as defined by Subsection 893.03(3), Florida Statutes.
Xanax is a brand name of alprazolam tablets, which is a benzodiazepine and is a Schedule IV controlled substance as defined by Subsection 893.03(4), Florida Statutes.
On or about April 27, 1988, Respondent found S.N. dead in her apartment.
An autopsy revealed that the probable cause of death of S.N. was convulsive seizure due to cardiac arrhythmia due to acute ethanol and drug intoxication. The autopsy further revealed that S.N.'s blood and urine contained significant quantities of ethanol, phenobarbital and benzodiazipine.
Respondent had prescribed to S.N. Xanax, a benodiazipine on or about April 15, 1988; Phenobarbital on or about April 19, 1988 and Quinaglute, a drug to control cardiac arrhythmia on or about April 19, 1988.
A reasonably prudent similar naturopathic physician under similar conditions and circumstances would have created a medical records including at least a social history i.e., use of ethanol); or the warnings, if any, given to the patient in regard to the use of these drugs. Respondent failed to create such a medical record.
Respondent committed gross malpractice in the treatment of S.N.
Respondent failed to keep written medical records justifying the course of treatment of S.N., including but not limited to, patient histories, examination results, test results, x-rays and records of the prescribing, dispensing and administering of drugs.
Before patient S.N.'s death, she had a social relationship with Respondent and traveled with Respondent. S.N. established a joint bank account with Respondent with rights of survivorship.
After patient S.N.'s death, Respondent withdrew approximately
$18,800.00 from the aforementioned bank account.
Respondent testified that S.N. wanted to repay him for previous loans to her family members in the amount of $13,000.
FINDING OF FACT CONCERNING PATIENT M.C.P.
On or about April 1, 1987, patient M.C.P. presented to Respondent at the MIWC, for treatment of a weight problem.
Respondent saw M.C.P. A minimum physical examination and blood test were performed, and Respondent prescribed the following legend drugs for M.C.P., purportedly to enable her to lose weight.:
Human Chorionic Gonadotropine (hereinafter: HCG) injections, and
Phentermine (Ionimin).
Also prescribed were thyroid pills, potassium glucanate and vitamin B-6.
On or about April 1, 1987, an employee of MIWC dispensed and administered legend drugs to M.C.P. without the direct supervision of Respondent, including, but not limited to, Human Chorionic Gonadotropin (HCG) and Phentermine, both Schedule IV controlled substances.
For approximately one (1)month after April 1, 1987, employees of MIWC dispensed and administered legend drugs to M.C.P. as ordered by Respondent, although Respondent did not directly supervise these employees.
The employees dispensing legend drugs to M.C.P. were not licensed pharmacists in the State of Florida.
Respondent did not perform any further examination or testing on patient M.C.P.
Respondent failed to keep sufficient medical records justifying the course of treatment of patient M.C.P.
FINDINGS OF FACT CONCERNING PATIENT J.S.
On or about September 20, 1988, patient J.S., an investigator for Petitioner acting in an undercover capacity, presented to Respondent at MIWC and requested treatment for a weight problem. J.S. was requested to obtain blood work.
On or about October 5, 1988, patient J.S. returned with the required blood work. MIWC employees took her blood pressure, pulse and weight. J.S. then met with Respondent. He explained the diet regime and provided J.S. with basal temperature instructions. Patient J.S. advised Respondent that she did not want any injections. Respondent advised patient J.S. that pills could be substituted for the injections, but that the results would not be "as spectacular."
On or about October 5, 11, and 18, 1988, J.S. was dispensed legend drugs by Sandra Kaye Smith at MIWC. Respondent was not present when the drugs were dispensed. However, on October 11, Respondent did examine J.S. because her blood pressure was elevated and changed her prescription.
Sandra Kaye Smith is not a licensed pharmacist.
Respondent failed to keep sufficient records justifying the course of treatment of patient J.S.
FINDINGS OF FACT CONCERNING PATIENT M.A.
On or about January 10, 1979, M.A. presented to Respondent at MIWC for treatment of a weight problem. Respondent conducted a limited physical examination of patient M.A.
From on or about January 10, 1979 until about January 16, 1988, Sandra Kaye Smith or other individuals dispensed legend drugs to M.A. inappropriately prescribed by Respondent and with Respondent's knowledge, although Respondent did not directly supervise these individuals.
Respondent failed to keep records justifying the course of treatment to patient M.A.
FINDINGS OF FACT CONCERNING THE OPERATION OF THE CLINICS
Many of the medicinal (legend) drugs dispensed at MIWC did not bear labels containing the following information:
patient's name;
date dispensed;
directions for use; or,
drug name or prescription number.
On May 20, 1986, an inspection was conducted at MIWC. Respondent had not conducted an inventory of all controlled substances at the time at hand on a biannual basis.
Respondent's standard practice in regard to new weight clinic patients is as follows:
Height, weight, blood pressure and pulse are recorded and blood is taken. Respondent sees patients for about fifteen minutes for an initial examination and they are not seen again by him unless they have problems; each patient is instructed to take their own basal temperature.
Patient's blood is checked for hemoglobin, uric acid, cholesterol and blood sugar only;
Reports are examined by Respondent if Respondent feels it is needed;
Respondent uses practically the same medication for everyone, including:
Thyroid pills,
HCG or lipotropics,
Potassium glucanate, and
Ionamin (brand name of phentermine).
Vitamin B-6
Folic acid
If the patient's blood pressure is elevated the clinic calls Respondent;
Clinic staff orders the units of phentermine for delivery at MIWC and another diet clinic
in Melbourne, Florida, and dispenses medicinal drugs without direct supervision.
Respondent, during the period of time February 10, 1984 through July 1989, has ordered the following quantities of medicinal drugs and controlled substances:
Phentermine 8 mg. 31,000
Phentermine 30 mg. 432,000
Phentermine 37.5 mg. 13,000
Thyroid 1/2 grain 1,243,000
Thyroid 1 grain 129,000
Thyroid 2 grain 72,000
HCG 422,000
Potassium 1,170,000
Respondent has provided to weight control patients a printed handout concerning the weight control program.
Petitioner has not demonstrated by clear and convincing evidence that HCG is not an effective adjunctive therapy in the treatment of obesity.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter of this proceeding, and the parties thereto, pursuant to subsection 120.57(1), Florida Statutes.
The Petitioner must prove the allegations in the Second Amended Administrative Complaint by clear and convincing evidence. Ferris v. Turlington, 510 So.2d 292 (Fla. 1987). Section 462.14, Florida Statutes, provides in pertinent part:
(1) The following acts constitute grounds for which the disciplinary actions specified in subsection (2) may be taken:
* * *
Failing to perform any statutory or legal obligation placed upon a licensed naturopathic physician.
(1) Making deceptive, untrue, or fraudulent representations in the practice of naturopathic medicine or employing a trick or scheme in the practice of naturopathic medicine when such scheme or trick fails to conform to the generally prevailing standards of treatment in the medical community.
Failing to keep written medical records justifying the course of treatment of the patient, including, but not limited to, patient histories, examination results, test results, x-rays, records of the prescribing, dispensing and administering drugs.
Exercising influence on the patient or client in such a manner as to exploit the patient or client for the financial gain of the licensee or of a third party, which shall include, but not be limited to, the promoting or selling of services, goods, appliances, or drugs and the promoting or advertising on any prescription form of a community pharmacy unless the form also states "This prescription may be filled at any pharmacy of your choice."
(q) Prescribing, dispensing, administering, mixing, or otherwise preparing legend drug, including any controlled substance, other than in the course of the naturopathic physician's professional practice. For purposes of this paragraph, it shall be legally presumed that the prescribing, dispensing, administering, mixing, or otherwise preparing legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the naturopathic physician's professional practice, without regard to his intent.
(t) Gross or repeated malpractice or the failure to practice naturopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.
Respondent was charged with violations of Subsection 462.14(1)(h), (1)(n), (o), (q), (t) and (w), Florida Statutes.
CONCLUSIONS OF LAW CONCERNING THE TREATMENT OF S.N.
Petitioner has established by clear and cnvincing evidence that Respondnet has prescribed legend drugs, including controlled substances, to S.N. inappropriateely and in excessive and inappropriate quantities. Section 462.14(1)(q), Florida Statutes, contains a presumption that prescribing inappropriately, or in excessive or inappropriate quantities constitutes prescribing other than in the course of the naturopathic physician's professional practice.
Section 462.14(1)(n), Florida Statutes, requires naturopathicc c physicians to keep written medical records justifying the course of treatment of patients. S.N. was Respondent's patient as evidenced by his long term prescribing of legend drugs and controlled substances to S.N. Respondent maintained no medical records for this individual with the exception of a partial list of drugs prescribed. This list does not satisfy the requirement to maintain medical records justifying the course of treatment of the patient. The Respondent has admitted that he conducted no physical examination of the patient. The medical records maintained contain no patient history, examination result, test result, and only a partial list of the drugs prescribed. Respondent, in regard to his treatment of S.N., has failed to keep written medical records justifying his course of treatment of the patient and has violated Section 462.14(1)(n), Florida Statutes.
Section 893.05, Florida Statutes, provides in pertinent part:
A practitioner, in good faith and in the course of his professional practice only, may prescribe . . . a controlled substance . .
Respondent's prescribing of controlled substances to patient S.N. was not done in good faith. Respondent is a practitioner as contemplated under Section 893.05, Florida Statutes. See Section 893.02(16), Florida Statutes. Therefore, it is concluded that the Respondent was under a statutory or legal obligation to prescribe controlled substances only in good faith. Respondent has breached this responsibility and has violated the provisions of Section 462.14(1)(h), Florida Statutes, by violating a statutory or legal obligation.
Respondent, for the reasons set forth in the Findings of Fact above, has committed gross malpractice and has failed to practice naturopathic medicine with that level of care, skill and treatment which is recognized by a reasonably prudent which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.
(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.
Respondent was charged with violations of Subsection 462.14(1) (h), (1),(n),(o),(q),(t) and (w), Florida Statutes.
CONCLUSIONS OF LAW CONCERNING THE TREATMENT OF S.N.
Petitioner has established by clear and convincing evidence that Respondent has prescribed legend drugs, including controlled substances, to S.N. inappropriately and in excessive and inappropriate quantities. Section 462.14(1)(q), Florida Statutes, contains a presumption that prescribing inappropriately, or in excessive or inappropriate quantities, constitutes prescribing other than in the course of the naturopathic physician's professional practice.
Section 462.14(1)(n), Florida Statutes, requires naturopathic physicians to keep written medical records justifying the course of treatment of patients. S.N. was Respondent's patient as evidenced by his long term prescribing of legend drugs and controlled substances to S.N. Respondent maintained no medical records for this individual with the exception of a partial list of drugs prescribed. This list does not satisfy the requirement to maintain medical records similar physician as being appropriate under similar conditions and circumstances, in regard to his treatment of S.N. Therefore, Respondent has violated the provisions of Section 462.14(1)(t), Florida Statutes.
Although Respondent's relationship with patient S.N. and his prescribing of medicinal drugs and controlled substances to her gives the appearance that Respondent has exercised influence over this patient, the appearance of undue influence is not enough. The evidence is not clear and convincing that Respondent has exercised influence on this patient in such a manner as to exploit the patient for financial gain of the licensee in violation of Section 462.14(1)(o), Florida Statutes.
CONCLUSIONS OF LAW CONCERNING THE WEIGHT CLINIC PATIENTS
Based upon the Findings of Fact set forth above, it is concluded that Respondent has committed repeated malpractice and has failed to practice naturopathic medicine with that level of care, skill and treatment which is recognized by a reasonably prudent, similar physician as being acceptable under similar conditions and circumstances in regard to his treatment of weight clinic patients in violation of Section 462.14(1)(t), Florida Statutes.
Respondent's medical records for the weight clinic patients are insufficient to justify the course of treatment of the patients. Therefore, Respondent has failed to keep written medical records justifying the course of treatment of the patients including, but not limited to, patient histories, examination results, test results, x-rays, and records of the prescribing, dispensing and administering of drugs, all in violation of Section 462.140(1)(n), Florida Statutes.
Based upon the Finding of Fact above, it is concluded that Respondent has dispensed and administered legend drugs, including controlled substances, inappropriately. Based upon the presumption contained in Section 462.14(1)(q), Florida Statutes, Respondent has dispensed and administered legend drugs, including controlled substances other than in the course of his professional practice in violation of Section 462.14(1)(q), Florida Statutes.
Former Section 465.027(2), Florida Statutes (1979), provided in pertinent part:
Nothing in this Chapter shall be construed to prevent a practitioner authorized by law to prescribe medicinal drugs from compounding, dispensing, or giving such drugs to his patients in the regular course of his practice. Such compounding and dispensing may be done only by the practitioner himself and shall comply with all Federal and State Laws relating to the labeling and dispensing of medicinal drugs.
The provisions of Section 465.027(2), Florida Statutes, were interpreted in two significant opinions. In Parr et al. v. Spires, 41 So.2d 36 (Fla. 1949), the Supreme Court held that a physician's employees, though not registered pharmacists, may lawfully for the doctor's own patients only, dispense, compound and sell any medicinal drugs, provided such dispensing, compounding and selling are done under the doctor's constant and immediate supervision and direction.
In addition, in 1963 the First District Court of Appeal in Love v. Escambia County, 157 So.2d 205 (Fla. 1st DCA 1963) stated the language in Chapter 465, Florida Statutes, creating an exception for a physician "himself" dispensing is satisfied where the dispensing is done under the immediate supervision of a physician. The Court stated that the letter and spirit of the statutes is complied with where such dispensing is done under the immediate direction of the physician.
In 1986, the Legislature deleted Section 465.027(2), Florida Statutes, and enacted Section 465.0276, Florida Statutes, which provides:
A person may not dispense medicinal drugs unless licensed as a pharmacist or
otherwise authorized under this chapter to do so, except that a practitioner authorized by law to prescribe drugs may dispense such drugs in the course of his practice in compliance with this section.
A practitioner who dispenses medicinal drugs for human consumption for fee or remuneration of any kind whether direct or indirect, must:
* * *
(b) Comply with and be subject to all laws and rules applicable to pharmacists and pharmacies, including, but not limited to, this chapter, chapter 499 and chapter 893 and all federal laws and federal regulations.
It is concluded, therefore, that the Respondent, as a practitioner authorized to prescribe medicinal drugs, (see Section 462.01, Florida Statutes) may dispense the drugs himself to his patients in the regular course of his practice provided he complies with all laws and rules governing the practice of pharmacy.
Section 465.003(5), Florida Statutes, provides in pertinent part:
"Dispense" means the transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer or his agent. As an element of dispensing, the pharmacist shall, prior to the actual physical transfer, interpret and assess the prescription . . . and he shall certify that the medicinal drug called for by the prescription is ready for transfer.
Rule 215-4.002(2), Florida Administrative Code, confirms the responsibility of the pharmacist, and therefore, the physician in the dispensing act and provides:
(2) Pursuant to the direction of the
licensed pharmacist, pharmacy technicians may 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 in a computer system and the entry of prescription information or physician's orders into a computer system. The pharmacist, however, must complete the dispensing act and initial the prescription.
Therefore, under both Section 465.027(2), Florida Statutes (1979) and Section 465.0276 (1987), Florida Statutes, Respondent was obligated to personally dispense or to certify that the medicinal drugs called for by the prescription were ready for transfer. In addition, Respondent was obliged to comply with all statutes and regulations governing the practice of pharmacy.
Rule 215-1.013(1), Florida Administrative Code, is a rule of the Board of Pharmacy, applying to pharmacies and pharmacists. Said rule provides that labels of all non-controlled substances must include the following information:
Name and address of the pharmacy;
the name of the prescriber;
the name of patient;
the date of the original filling or refill date;
the prescription number or other prescription information adequate to readily identify the prescription;
the directions for use; and,
the name of the medicinal drug dispensed (except where the health care practitioner prescribing the drug specifically denotes that the name is to be withheld).
In addition, Section 893.05, Florida Statutes, provides in pertinent part:
(2) When any controlled substance is dispensed by a practitioner, there shall be affixed to the original container in which
the controlled substance is delivered a label on which appears:
A date of delivery;
the directions for use of the controlled substance;
the name and address of the practitioner;
the name of the patient;
a clear and concise warning that it is a crime to transfer the controlled substance to any person other than the patient for whom it is pre- scribed.
Rule 21S-1.014, Florida Administrative Code, requires that the prescription department be closed when a licensed pharmacist is not present. Therefore, no drugs can be dispensed in the absence of a licensed pharmacist. Likewise, this regulation would be applicable to dispensing practitioners.
Respondent permitted staff members not licensed as pharmacists to dispense medicinal drugs, including controlled substances when he was not present, and had not certified the drugs as being ready for dispensing. In addition, the labels utilized by the Respondent did not meet the requirements of Florida law. Respondent has, therefore, violated the following:
Respondent has delegated professional responsibilities to a person when he knew or had reason to know that such person was not qualified by training, experience, or licensure to perform them; to wit, dispensing of medicinal drugs and controlled substances, in violation of Section 462.14(1)(w), Florida Statutes.
Respondent has failed to perform a statutory or legal obligation in violation of Section 462.14(1)(h), to wit, by allowing the dispensing of drugs other than under his direct supervision, or in violation of Section 893.05(1), Florida Statutes, and without proper labeling in violation of Florida Statutes and rules set forth above.
Section 893.07, Florida Statutes, requires that all practitioners make a complete and accurate inventory of all controlled substances on hand on a biennial basis. Respondent failed to conduct the required inventories. Therefore, Respondent has violated Section 462.14(1)(h), Florida Statutes, by failing to perform any statutory or legal obligation placed upon a licensed naturopathic physician.
Respondent has made representations concerning the effects of HCG as an effective adjunctive therapy in the treatment of obesity both verbally and in the printed handout provided to weight control patients on a routine basis. The representations contained in the handout and made to patients have not been shown to be deceptive, untrue or fraudulent, by clear and convincing evidence. Therefore, Respondent is not guilty of violating of Section 462.14(1)(l), Florida Statutes.
It is concluded that Petitioner has established by clear and convincing evidence that Respondent has violated the provisions of Subsections 462.14(1)(h),(n),(q),(t) and (w), Florida Statutes.
Section 462.14(2), Florida Statutes, provides in pertinent part:
(2) When the department finds any person guilty of any of the grounds set forth in subsection (1), it may enter an order imposing one or more of the following penalties:
(b) Revocation or suspension of license.
(d) Imposition of an Administrative Fine not to exceed $1,000.00 for each count or separate offense.
Based on the foregoing findings of fact, conclusions of law and the multiple and continuing violations as demonstrated, it is recommended:
That the license of Jesse Alexander as a naturopathic physician be revoked and that an administrative fine of $4,000 be imposed.
DONE AND ENTERED this 7th day of August, 1990, in Tallahassee, Leon County, Florida.
DANIEL M. KILBRIDE
Hearing Officer
Division of Administrative Hearings The DeSoto Building
1230 Apalachee Parkway
Tallahassee, Florida 32399-1550
(904)488-9675
Filed with the Clerk of the Division of Administrative Hearings this 7th day of August, 1990.
APPENDIX TO RECOMMENDED ORDER CASE NO. 89-6093
The following constitutes my specific rulings, in accordance with section 120.59, Florida Statutes, on findings of fact submitted by the parties.
Petitioner's Proposed Findings of Fact:
Accepted: Paragraphs 1, 2, 3, 4 (in substance), 5, 6, 7, 8, 9, 10, 11, 13 (in
substance), 14, 15, 16, 17 (in part), 18, 19, 20, 21, 22, 24, 25, 25(#2), 26,
27, 28, 29, 30, 31, 33, 34, 35, 36 (in part), 37, 38, 46, 48, 49 (in substance)
51, 53 (in part)
Rejected: Paragraphs 12 (conclusion of law), 23 (against the greater weight of the evidence), 32, 33, 39 through 44 (repetitious finding), 45 (conclusion of
law), 47 (conclusion), 50 (conclusion), 52 (conclusion) 54 (against the greater weight of the evidence)
Respondent's Proposed Findings of Fact:
Respondent's proposals have been carefully reviewed and incorporated when supported by the evidence. However, Respondent's proposals, for the most part, are a recitation of the testimony of witnesses, documents in the evidence and argument. Therefore, findings of fact 2-4,6-60 are rejected.
COPIES FURNISHED:
Bruce D. Lamb, Esquire Chief Trial Attorney Department of Professional Regulation, Suite 201
730 S. Sterling Street Tampa, FL 33609
Steven J. Jacovitz, Esquire
43 S. Atlantic Avenue Cocoa Beach, FL 32931
Lawrence A. Gonzalez Secretary
Department of Professional Regulation
Northwood Centre
1940 North Monroe Street Suite 60
Tallahassee, FL 32399-0792
Kenneth E. Easley General Counsel
Department of Professional Regulation
Northwood Centre
1940 North Monroe Street Suite 60
Tallahassee, FL 32399-0792
=================================================================
AGENCY FINAL ORDER
=================================================================
STATE OF FLORIDA
DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF MEDICINE
DEPARTMENT OF PROFESSIONAL REGULATION,
Petitioner,
vs. DOAH CASE NO. 89-6093
DPR CASE NOS. 0063804
JESSE ALEXANDER, M.D., 0063805
0090289
Respondent. 0103905
/
FINAL ORDER
This cause came before Larry Gonzalez, the Secretary of the Department of Professional Regulation, as agency head, pursuant to Section 120.57(1)(b), Florida Statutes, for the purpose of considering the Recommended Order issued in this cause. A copy of the Recommended Order is attached hereto and incorporated herein.
Upon review of the Recommended Order, and after a review of the complete record in this case, the Department of Professional Regulation, by and through its agency head and Secretary, Larry Gonzalez, makes the following findings and conclusions.
Findings of Fact
The findings of fact set forth in the Recommended Order are approved and adopted, with one exception as noted below, and, with that exception, are incorporated herein.
In the Recommended Order, at page 13, paragraph 38, a scrivener's error exists. The paragraph currently states:
"On May 20, 1986, an inspection was conducted at MIWC. Respondent had not conducted an inventory of all controlled substances at the time at hand on a biannual (sic) basis."
As corrected, the paragraph should state:
"On May 20, 1986, an inspection was conducted at MIWC. Respondent had not conducted an inventory of all controlled substances at the time at hand on a biennial basis."
In this regard, see Petitioner's Exhibits 9 and 10.
2. Competent substantial evidence exists to support the findings of fact, as modified by the Secretary's action regarding Finding of Fact 38.
Conclusions of Law
The Department of Professional Regulation, by and through its agency head and Secretary, Larry Gonzalez, has jurisdiction of this matter pursuant to Section 120.57(1), Florida Statutes, and Chapter 462, Florida Statutes.
The Conclusions of Law set forth in the Recommended Order are approved and adopted and said Conclusions of Law are incorporated herein.
Penalty
Upon a complete review of the record in this case, the Department of Professional Regulation, by and through its agency head and Secretary, Larry Gonzalez, determines that the recommended penalty of the hearing officer be ACCEPTED.
WHEREFORE, IT IS HEREBY ORDERED AND ADJUDGED that the license to practice naturopathy, number NA 0000515, of Jesse L. Alexander, M.D., shall be revoked and Jesse Alexander, M.D., shall further pay an administrative fine in the amount of $4,000.00.
DONE AND ORDERED THIS 25th day of September, 1990.
LARRY GONZALES SECRETARY
Notice of Right to Judicial Review
Pursuant to Section 120.68, Florida Statutes, the parties are hereby notified that they may appeal this Final Order by filing one copy of a Notice of Appeal with the Clerk of the agency and by filing the filing fee and copy of a Notice of Appeal with the District Court of Appeal within thirty (30) days of the date that this Order is filed, as provided in Chapter 120, Florida Statutes, and the Florida Rules of Appellate Procedure.
CERTIFICATE OF SERVICE
I HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished to Steven J. Jacovitz, Esquire, 43 South Atlantic Avenue, Cocoa Beach, Florida 32931; Jesse L. Alexander, N.D., at 1100 South Orlando Avenue, #106, Maitland, Florida 32751- 6464; and to Bruce D. Lamb, Chief Litigation Attorney, at 730 South Sterling Avenue, Suite 313, Tampa, Florida 33609-4582, by United States Mail this 25th day of September, 1990.
Stephanie A. Daniel Chief Medical Attorney
Department of Professional Regulation
| Issue Date | Proceedings |
|---|---|
| Aug. 07, 1990 | Recommended Order (hearing held , 2013). CASE CLOSED. |
| Issue Date | Document | Summary |
|---|---|---|
| Sep. 25, 1990 | Agency Final Order | |
| Aug. 07, 1990 | Recommended Order | Naturopathic physician`s license revoked for prescribing legend drugs inappropriately; failed to keep records; improper procedure at weight control clinic. |
