Findings Of Fact The Respondent, Peter Kurachek, was a licensed dentist at all times relevant to the allegations contained in the Administrative Complaint, having been issued license number 0005429, and was so licensed at the time of hearing. On January 19, 1981, Clarence Nicholson consulted the Respondent at the Sheppard Dental Center in Clearwater, Florida, regarding a dental problem. The Respondent performed a root canal treatment on Nicholson's tooth number six, a cuspid, and prepared the tooth to receive a crown. On January 31, 1981, the Respondent installed the permanent crown, which he had had prepared. In August 1981, the crown fell out, and Nicholson returned to the Sheppard Dental Center. Nicholson did not see the Respondent on this visit, and the crown was recemented by Dr. Christopher Clarke. In November 1981, the crown fell out a second time. Nicholson returned to the Sheppard Dental Center. On this occasion, Nicholson did not see Respondent, and the crown was recemented in place by Dr. Clarke. Dr. Clarke made no gross alterations to the crown on either of the appointments; however, he did clean the crown in preparation for recementing it on both occasions. Shortly after Dr. Clarke recemented the crown the second time, Nicholson saw Respondent and requested that he correct the crown. The Respondent advised Nicholson that he would be happy to replace the crown and redo the work if the crown became loose again. Respondent feared that forcefully removing the crown in order to prepare a new one might damage Nicholson's tooth. Because he would be responsible if the tooth were broken while removing the crown, the Respondent elected to deal with Nicholson's problem if the crown became loose again of its own accord. In April 1982, more than a year after Respondent did the work for Nicholson, and after the crown had been recemented twice by another dentist, Nicholson was examined by Dr. Paul Hounchell, a dental consultant for the Petitioner. As a result of his examination, Dr. Hounchell opined that the treatment provided by the Respondent did not meet the minimal accepted standards of practice in the community. (Tr. 81.) However, Dr. Hounchell indicated that his opinion was based upon the fact that Nicholson was unable to have the crown fixed to his satisfaction. Dr. Hounchell stated, "The only unprofessional thing is that we run this man around, you know, for a half a year, a year or something like that." (Tr. 121.) The record reflects that Nicholson only saw the Respondent one time after the Respondent installed the crown, and that on that occasion the Respondent told Nicholson that he would replace the crown to Nicholson's satisfaction if the crown became loose again. The record further reflects that Nicholson never tried to see the Respondent thereafter. The tooth in question was a nonvital tooth as a result of the root canal therapy. Such a tooth is more brittle and may fracture more easily. However, the tooth had a good-sized large root which was adequate to support a longer post. The various dentists disagree concerning whether it would have been appropriate for the Respondent to have removed the crown when he saw Nicholson after Dr. Clarke had recemented the crown in place. The treatment provided by the Respondent to Nicholson met minimum acceptable standards of practice in the community.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the charges against the Respondent, Peter Kurachek, D.D.S., be dismissed. DONE and RECOMMENDED this 25th day of April, 1983, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 25th day of April, 1983. COPIES FURNISHED: Julie Gallagher, Esquire Department of professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Peter Kurachek, DDS 703 Tropical Circle Sarasota, Florida 33581 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 H. Fred Varn, Executive Director Board of Dentistry 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact At all times material hereto, Respondent has been licensed as a dentist in the State of Florida, having been issued license number DN-00003723. On November 15, 1982, the Board of Dentistry filed an Order in Case Number 0015545 (DOAH Case No. 82-1292) which approved and adopted a stipulation which Respondent had executed on October 5, 1982, in which he admitted that dental assistants who were employed by him and who were not licensed to practice dentistry in the State of Florida, had, in the course of their employment and with Respondent's knowledge, performed the task of forming orthodontic archwires. Based upon this stipulation, the Board of Dentistry disciplined Respondent's license by imposing a reprimand and assessing an administrative fine in the amount of $5,000. On or about August 18, 1986, the Respondent rendered treatment to the patient Dean Fodera which included, but was not limited to, orthodontic care for the patient. At the time, Dean Fodera was fourteen years old. Specifically, the Respondent placed fixed appliances, or braces, on Dean Fodera's teeth. After these appliances had been in place until June, 1987, Respondent determined that they could be removed and replaced with a retainer. As a result, Fodera was seen on June 11, and 30, 1987, at Respondent's dental office for the removal of his braces. However, Respondent did not personally remove Fodera's braces on either visit. While Respondent was present in the office and saw Fodera on the June 11, 1987, visit, the patient's posterior braces (bands and brackets) were actually removed by Robin Crews, a dental assistant employed by Respondent who is not licensed to practice dentistry in the State of Florida. On June 30, 1987, Respondent was not present in his office, and although another licensed dentist, Kenneth R. Scherer, was present in the office, Dr. Scherer did not treat Fodera. Instead, his remaining braces (anterior brackets) were also removed by Robin Crews on June 30, 1987. Dr. Scherer was not aware of the fact that Fodera's remaining braces had to be removed during the June 30, 1987 visit, but rather was under the impression that he was only delivering the patient's retainer. The findings set forth in this paragraph are based upon the testimony of Dean Fodera, as well as that of his parents and the deposition testimony of Dr. Scherer, which is specifically found to be more credible than the testimony of Robin Crews. While in the employ of Respondent from 1985 to 1988, Robin Crews routinely and repeatedly removed fixed appliances, or braces, from patients while Respondent was not present and with his full knowledge. The removal of fixed orthodontic appliances, such as braces, is an irremediable task, and is not a function that a dentist can delegate to a non- dentist because there is a significant chance of irremediable tooth fractures when braces are removed, or other tooth damage in the removal of adhesive materials. Respondent received payment by checks dated June 11 and 30, 1987, in the total amount of $205.00 for services performed on these dates for Deane Fodera. Based upon the testimony of David L. Leever, who was accepted as an expert in orthodontics, Myron Graff, a licensed dentist specializing in orthodontia, and the deposition testimony of Lucas E. Stevens, who is accepted as an expert in orthodontics, it is found that the care and treatment rendered to the patient Dean Fodera by the Respondent between August 18, 1986, and June 30, 1987, failed to meet the minimum acceptable standards in the dental profession. Specifically, when his braces were removed, Dean Fodera had a remaining overbite of 4mm, required a composite restoration of his maxillary left lateral incisor, and exhibited labioversion of his maxillary left lateral incisor as well as severe mobility and occlusal trauma. Labial root torque of his maxillary left cuspid was also noted in addition to posterior malocclusion. The only form of continuing treatment provided for Dean Fodera by Respondent was a standard Hawley retainer. It was established that a Hawley retainer could not correct this patient's severe mobility and occlusal trauma that was noted at the time. Respondent's decision to remove orthodontic appliances from Dean Fodera in June's 1987, was premature, absent a continuing treatment plan which could effectively address his remaining dental problems. His premature removal of these fixed appliances, and also his failure to provide an adequate continuing treatment plan constitutes the practice of dentistry below acceptable minimum standards of care. On October 20, 1988, a probable cause panel met to consider the investigative report in this matter. The members present, Dr. William F. Robinson and Mr. Tom Kraemer, both voted to find probable cause, and a memorandum of finding of probable cause panel was prepared on October 26, 1988. Official recognition was taken of Rule 21G-1.001, Florida Administrative Code, which authorizes a finding of probable cause by majority vote, or two members, of a panel consisting of three members. Thus, the finding of probable cause in this instance was properly made by two members of the probable cause panel. The facts in this case are distinguishable from those in Kibler v. Department of Professional Regulation, 418 So.2d 1081, 1083 (Fla. 4th DCA 1982), wherein the Court found that despite the clear requirements of applicable statutes and rules that there be at least two members on the probable cause panel, one board member and a lay member, an improperly constituted panel consisting of only one board member was convened and found probable cause.
Recommendation Based upon the foregoing,, it is recommended that Board of Dentistry enter a Final Order imposing on Respondent an administrative fine of $6,000 and a six month period of suspension, provided however, that prior to its expiration, the Board of Dentistry may terminate this period of suspension and place Respondent on probation for an additional six months if the Respondent submits documentation f his satisfactory completion of at least thirty (30) hours of continuing education in the area of orthodontics, or as otherwise specified by the Board. DONE AND ENTERED this 31st day of August, 1990 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 31st day of August, 1990. APPENDIX DOAH CASE NO. 89-0981 Rulings on the Petitioner's Proposed, Findings of Fact: Rejected as unnecessary. Adopted in Finding 1. 3-4. Adopted in Finding 3. 5. Adopted in Finding 4. 6-8. Adopted in Findings 8-10. 9-10. Adopted in Finding 9. 11. Adopted in Findings 8-10. While the Respondent filed several post-hearing documents, including a Special Appearance Concerning Jurisdictional Impropriety, a Special Appearance on Constructive Notice and Summation of Facts, and a Special Appearance Objecting To and Rebutting Petitioner's Proposed Recommended Order, none of these documents set forth specific proposed findings of fact upon which specific rulings can be made. They consist largely of legal argument, summations of testimony, and are lacking in any citation to the record, as required by Rule 22I-6.03)(3), F.A.C. COPIES FURNISHED: Bruce D. Lamb, Esquire Chief Trial Counsel 730 South Sterling Street Suite 201 Tampa, FL 33609 Alexander Buchwald, D.D.S. 3025 Lakewood Lane Hollywood, FL 33021 Kenneth E. Easley, General Counsel 1940 North Monroe Street Tallahassee, FL 32399-0792 William Buckhalt, Executive Director Board of Dentistry 1940 North Monroe Street Tallahassee, FL 32399-0792 =================================================================
Findings Of Fact In the November 27, 1985 edition of The Florida Administrative Weekly, Volume 11, Number 48, the Board noticed Proposed Rules 21G-14.001(7) and 21G-14.005(1), Florida Administrative Code, which were timely challenged by petitioner and which provide as follows: 21G-14.001 Definitions. * * * (7) Office team approach - A methodology employed by a dentist in the administration of general anesthesia and parenteral conscious sedation whereby the dentist may use one or more qualified anesthetic auxiliaries who, working under the direct supervision of the dentists assist the dentist, and assist in emergency care of the patient. 21G-14.005 Application for Permit. (1) No dentist shall administer or super- vise the administration of general anesthesia, or parenteral conscious sedation in a dental office for dental patients, unless such dentist possesses a permit issued by the Board. The dentist holding such a permit shall be subject to review and such permit must be renewed biennially. The cited statutory authority for these proposed rules includes Sections 466.004(3) and 466.017(3), Florida Statutes. Parenteral conscious sedation is defined by proposed Rule 210-14.001(6), which is not challenged in this case, as 21G-14.001 Definitions. * * * (6) Parenteral conscious sedation - A depressed level of consciousness produced by the parenteral administration of pharma- cologic substances, that retains the patient's ability to independently and continuously maintain an airway and respond appropriately to physical stimulation or verbal command. This modality includes administration of medications via all parenteral routes, that is: intravenous, intramuscular, subcutaneous, submucosal, or inhalation. A patient who is receiving parenteral conscious sedation will frequently slip in and out of consciousness, or a state of general anesthesia. General dentists do not receive adequate training in undergraduate dental school in the administration of general anesthesia and the treatment of medical emergencies which may result there from, and are not qualified to administer general anesthesia or treat resulting medical emergencies. The evidence is undisputed that a dentist who lacks the additional training in general anethesia and parenteral conscious sedation, which would be required under these rules, is not capable of competently and safely administering anesthesia or sedation himself, and does not possess the ability to competently assess all risks attendant to the administration of general anesthesia or parenteral conscious sedation. Additionally, such a dentist is not able to competently assess whether a patient is an acceptable risk for anesthesia or sedation, or to react to medical complications that may arise, such as respiratory obstruction and arrest, allergic or idiosyncratic reaction to drugs, cardiac arrest, miocardial infarction, seizures, and hypertensive crises. Since general dentists without further training in anesthesia are not qualified to administer general anesthesia in their dental office, or treat resulting medical emergencies, they are also not qualified to supervise the administration of general anesthesia in their office. The educational training received by undergraduate dentists in accredited dental schools in the United States and Canada offers only a brief didactic exposure to general anesthesia and parenteral conscious sedation of about 48 classroom hours. Clinical training is not offered. It is only at the graduate level of training, internship or residency programs that dental schools are required to offer training in dealing with medical emergencies. The general dentist does not maintain the equipment necessary to deal with medical emergencies and life threatening occurrences. Life threatening medical emergencies can develop while a patient is under general anesthesia, and a dentist administering or supervising the administration of general anesthesia must be able to deal with such emergencies. Undergraduate dental schools devote less than twenty-one hours in their entire program to the handling and treatment of medical emergencies and the evaluation of patients, and this does not prepare a general dentist without further training to deal with such emergencies. Certified registered nurse anesthetists (CRNA) are licensed by the Board of Nursing as advanced registered nurse practitioners. According to Nursing Board Rule 210-11.22, Florida Administrative Code, amended June 18, 1985: 210-11.22 Functions of the Advanced Registered Nurse. All categories of Advanced Registered Nurse Practitioner may perform functions listed in Section 464.012(3), F.S. The scope of practice for all categories of ARNPs shall include those functions which the ARNP has been educated to perform including the monitoring and altering of drug therapies, according to the established protocol and consistent with the practice setting. Specific activities which a CRNA may perform are enumerated in Section 464.012(4)(a), Florida Statutes (1984 Supplement). However, Section 464.012(3) specifies that these activities must be within the framework of an established protocol and that a licensed medical doctor, osteopathic physician or dentist shall maintain supervision for directing the specific course of medical treatment on any patient. Thus, a CPNA is not authorized to work independently on patients, but must operate within established protocols and under supervision. In order to become a CRNA, a registered nurse with at least one year's clinical experience in critical care nursing has to graduate from a two year accredited nurse anesthetist program comprised of approximately 425 contact hours, and also conduct 450 administrations of anesthesia consisting of 800 hours of actual anesthesia time. Thus, a CRNA has more training and experience in the administration of anesthesia than a general dentist receives in undergraduate dental school. The proposed rules in question were adopted to preclude a general dentist from employing a CRNA to administer anesthesia in his office unless he has received training beyond undergraduate dental school in anesthesia and has obtained a permit from the Board. As expressed in the Purpose and Effect portion of the notice for these proposed rules: The effect of the proposed amendment will be further assurance that those dentists who are using anesthesia, and related forms of sedation, have met minimal standards designed to protect the public's health, safety and welfare . . . * * * The purpose of the proposed rules is to implement the provisions of Section 466.017 (3)(e), F.S., as enacted by the 1985 Florida Legislature. The rules are designed to insure that those dentists who utilize general anesthesia or parenteral conscious sedation in a dental office for dental patients on an outpatient basis meet certain minimum qualifications. It is the opinion of the Board that dentists who administer or supervise the administration of general anesthesia or parenteral conscious sedation on an outpatient basis must satisfy certain training, equipment, and staffing requirements prior to engaging in such activity. The effect of the proposed rules is the establishment of a permitting procedure, as well as the requirement that adverse occurrences resulting from the use of nitrous- oxide inhalation analgesia, parenteral conscious sedation, general anesthesia be reported. These new procedures and require- ments should enhance the protection of the public from-licensees who are otherwise not competent to use general anesthesia, parenteral conscious sedation, or nitrous- oxide inhalation analgesia. The Economic Impact Statement (EIS) accompanying these proposed rules states, in pertinent part that: The proposed amendment will have some economic impact upon those licensees who are currently authorized to use general anesthesia and parenteral sedation. Upon the effective date of these rules, these individuals will be required to pay a permit application fee as well as expend those funds necessary to bring their training, equipment, and staffing level up to the requirements of the proposed rules. The precise number of dentists to be affected by the proposals and the precise impact upon them, other than the permit application fee, is not known at this time. * * * The proposed rules should have an economic impact upon those dentists who currently admin- ister or supervise the administration of general anesthesia and parenteral conscious sedation. Although the proposed rules do not in any way affect a dentist's ability to utilize general anesthesia or parenteral conscious sedation in a hospital or other medical facility, the rules will require the dentist to obtain a permit and to maintain his office at certain equipment and staffing level. Aside from the permit appli- cation feed the precise economic impact upon those dentists who currently utilize general anesthesia or parenteral sedation is not known at this time. It is anticipated that any additional costs to the practitioner will be passed on to the consumer. The fact that patient costs might increase as a result of these proposed rules was supported by Petitioner's witnesses Ira Gunn and Barbara Quick, but neither witness offered any more detailed information about the economic impact of these proposed rules than is contained in the Economic Impact Statement. Further, Petitioner offered no evidence to show that the proposed rules would affect persons other than those referenced in the Economic Impact Statement. It has not been demonstrated that the Economic Impact Statement is either inadequate, misleading or inaccurate. The evidence in the record is insufficient to support a finding that Petitioner is a non-profit corporation registered in Florida and is composed of a majority of the licensed nurse anesthetists in Florida, that it is the only Florida association of general membership representing nurse anesthetists, or that many of its members will be substantially affected by these rules. There is no evidence of Petitioner's legal status, its purposes as reflected in any by-laws, its membership, or the number of members who will be substantially affected by the rules. Thus, Petitioner has not proven the allegations in its petition regarding its standing in this matter.
The Issue Whether proposed rule 64B16-27.830 of the Board of Pharmacy (Board) is an invalid exercise of delegated authority pursuant to Section 120.52(8), Florida Statutes?
Findings Of Fact Respondent, Board of Pharmacy is the state entity charged with regulating the practice of pharmacy in the State of Florida pursuant to Section 20.43 and Chapters 456 and 465, Florida Statutes. Petitioner, the FMA, is organized and maintained for the benefit of the approximately 16,000 licensed Florida physicians who comprise its membership. One of the primary purposes of the FMA is to act on behalf of its members by representing their common interests before various governmental entities in the State of Florida, including the Department of Health and its Boards. Intervenors comprise 33 medical societies representing physicians licensed pursuant to Chapters 458 and 459, Florida Statutes. The membership totals for each of the Intervenors is listed in Petitioner's Exhibit 1. A primary purpose of each of the Intervenors is to act on behalf of its membership by representing their common interests before the various governmental entities of the State of Florida, including the Department of Health and its Boards. The Proposed Rule The text of the proposed rule is as follows: 64B16-27.830 Standards of Practice - Drug Therapy Management. through (3) No change A pharmacist may dispense a drug pursuant to a prescription where the practitioner indicates on the prescription "formulary compliance approval" either in the practitioner's own handwriting or preprinted with a box where the practitioner indicates approval by checking the box when: The pharmacist receives a formulary change as a consequence of the patient's third party plan or Medicaid. The product that the third party formulary designates as its preferred product is a therapeutic equivalent for the prescribed product. A therapeutic equivalent is a product that is in the same therapeutic class as the prescribed drug. The pharmacist, within 24 hours of the formulary compliance substitution, shall provide to the practitioner either in writing or by facsimile a statement indicating that the pharmacist engaged in formulary compliance and the therapeutic equivalent that the pharmacist dispensed. The pharmacist has complied with the requirements of Rule 64B16-27.530 with regard to the notification to the patient. The pharmacist may make adjustments in the quantity and directions to provide for an equivalent dose of the preferred formulary therapeutic alternative. (5)(4) No change. Specific authority 465.005, 465.0155 F.S. Law implemented 465.003(13), 465.0155, 465.022(1)(b) F.S. Section 465.005, Florida Statutes, listed as specific authority, provides the Board's general rulemaking authority. Section 465.0155, Florida Statutes, listed as both specific authority and law implemented, directs the Board to adopt by rule standards of practice relating to the practice of pharmacy. Section 465.003(13), Florida Statutes, listed as law implemented, defines the practice of pharmacy. Section 465.022(1)(b), Florida Statutes, listed as law implemented, provides: The board shall adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this chapter. Such rules shall include, but shall not be limited to, rules relating to: . . . . (b) Minimum standards for the physical facilities of pharmacies. The Rulemaking Process On October 22, 2004, in Volume 30, Number 43, Florida Administrative Weekly, the Board published its Notice of Development of Proposed Rule 64B16-27.830, entitled "Standards of Practice - Drug Therapy Management." On October 29, 2004, the FMA requested a rule workshop. On November, 19, 2004, in Volume 30, Number 47, Florida Administrative Weekly, the Board published a notice of a rule workshop on the proposed rule to be held December 7, 2004, in Jacksonville, Florida. On December 7, 2004, the Board held a rule workshop on the proposed rule. On December 17, 2004, in Volume 30, Number 51, Florida Administrative Weekly, the Board published a notice of withdrawal of the proposed rule. On April 29, 2005, in Volume 31, Number 17, Florida Administrative Weekly, the Board published the same rule language again, this time as a proposed rule. On April 29, 2005, the FMA requested a rule hearing. On May 12, 2005, Suzanne G. Printy, Chief Attorney for the Joint Administrative Procedures Committee (JAPC), sent to Ann Cocheu, Assistant Attorney General for the Board of Pharmacy, a letter indicating that she had "completed a review" of the rule and questioning the Board's authority to promulgate the rule. On May 20, 2005, in Volume 31, Number 20, Florida Administrative Weekly, the Board published a notice of a rule hearing on the proposed rule to be held June 14, 2005, in Tampa, Florida. On June 14, 2005, the rule hearing was held before the Board. At that time, several individuals spoke in opposition to the proposed rule. The Board voted to conduct a further public meeting with respect to the proposed language. On July 14, 2005, F. Scott Boyd, Executive Director and General Counsel for JAPC sent to Ann Cocheu a letter advising her of the deadlines applicable to the rulemaking process. Specifically, Mr. Boyd's letter stated: According to our records, the above-styled rule was noticed in the Florida Administrative Weekly on April 29, 2005. Paragraph 120.54(3)(e), F.S., requires that rules be filed for adoption not more than 90 days from the date of the original notice unless specified circumstances prevail. The 90-day period for filing the rule expires on July 28, 2005. If you intend to adopt the rule, we remind you that paragraph 120.54(3)(d), F.S., requires that if the rule has not been changed since the rule was filed with the Committee, or if the rule contains only technical changes, you must file a notice to that effect with this Committee at least 7 days prior to filing the rule for adoption. If any change has been made in the rule, other than a technical change, you must publish a notice, and file a copy with the committee, at least 21 days prior to filing the rule for adoption. If the rule is not filed within 90 days, and if an exception is not applicable, you must notice withdrawal of the rule. Any further action to adopt the rule must comply with the rulemaking procedures of § 120.54, F.S. Please advise us of any exceptions which apply to the rule so that we may keep our records current. On July 21, 2005, a paralegal from the Office of the Attorney General wrote to Suzanne Printy at JAPC and requested to "toll" the proposed rule. The July 21, 2005, letter advised that the Board had scheduled a review of the rule at a committee meeting to be held on August 15, 2005. While the July 21, 2005, letter refers to a copy of the meeting notice for August 15, 2006, no notice for the meeting is included in the record. At no time did JAPC notify the Board that an objection to the proposed rule was being considered. On August 15, 2005, the Board's Rules Committee met again to review the proposed rule. Minutes from the committee meeting reflect that the Rules Committee reviewed letters from the Florida Medical Association and the Chair of the Osteopathic Board of Medicine in opposition to the rule. These written materials, however, are not included in Respondent's Exhibit 1, which purports to be the Board's entire record with respect to the rulemaking proceedings for amendments to Rule 64B16-27.830. The Executive Director of the Board acknowledged receiving letters from Laurie Davies, M.D., Chair of the Board of Medicine and from the Coalition to Protect Health Care Access, representing several patient advocacy organizations expressing opposition to the proposed rule. These documents, likewise, are not in the Board's rulemaking record. The minutes of the August 15, 2005, meeting indicate that the Committee voted to hold the rule until statutory authority was obtained to enact it. Ms. Poston, the Board's Executive Director, was to send a letter to the Attorney General's office asking for a formal opinion regarding the Board's statutory authority. There is no indication in the record of any activity with respect to the proposed rule from August 15, 2005, until April 26, 2006, when Suzanne Printy wrote to Reginald Dixon, Assistant Attorney General, regarding its status. Her letter states in part: On July 21, 2005, the Office of the Attorney General, Administrative Law Bureau, notified this office that the board was tolling the 90 day time limit for adoption of those amendments in order to accommodate review of the amendments by this Committee. That original 90 day time limit would have expired on July 28, 2005. As of this date, we have not received any proposed revisions or notices of change in response to my concerns. Please be aware that if I have not received a notice of change or a notice of additional public hearing on the amendments within the next two weeks, I will have to conclude that my review of the rule is complete. The tolling of the adoption will then come to an end, and the board will have 7 days within which to change, adopt or withdraw the amendments. On May 19, 2006, in Volume 32, Number 20, Florida Administrative Weekly, the Board noticed an additional public meeting on the proposed rule to be held June 6, 2006, in Fort Lauderdale. A copy of the notice was provided to Suzanne Printy on May 11, 2006, one day after the two-week period set out in her letter of April 26, 2006, expired. Nothing in the Notice of Public Hearing for the June 6, 2006, public hearing gives any indication that this will be the final public hearing related to proposed amendments to Rule 64B16-27.830. On May 22, 2006, Suzanne Printy acknowledged receipt of the Notice of Public Hearing published May 19, 2006. In a letter addressed to Reginald Dixon, she stated: Please be advised that at the conclusion of the hearing, presumably June 6, 2006, the Board of Pharmacy will have 45 days from the conclusion of the hearing, or until July 21, 2006, within which to either publish a notice of change, publish another notice of public hearing, or to adopt the rules. On June 6, 2006, the rule hearing was held. The Board did not publish a notice of change, publish another notice of public hearing or adopt the proposed rule by July 21, 2006. Nor did the Board publish any notice that would indicate the June 6, 2006, hearing was intended to be the last public hearing on the proposed rule. However, Rebecca Poston, Executive Director for the Board of Pharmacy, testified that the Board voted to "move forward" with the rule. On July 20, 2006, Reginald Dixon advised Suzanne Printy of the Board's consideration of JAPC's concerns regarding the proposed amendments to Rule 64B16-27.830, and stated that the Board believed the amendment to the rule was authorized by the 1999 change to Section 465.003(15), adding "other pharmaceutical services" to the definition of the practice of the profession of pharmacy. Mr. Dixon stated that "The Board believes that this explanation addresses JAPC's concerns regarding the 64B16- 27.830(4), F.A.C., and has voted to go forward with the promulgation of the rule." On August 11, 2006, Ms. Printy again wrote to Mr. Dixon, reiterating JAPC's concerns about the rule: This rule authorizes pharmacists to dispense drugs from the same therapeutic class as the prescribed drug, pursuant to a prescription where the practitioner authorizes on the prescription "formulary compliance approval." Please explain whether a "therapeutic equivalent" of a prescribed drug which is in the same "therapeutic class" constitutes a generic equivalent. If a "therapeutic equivalent" of a prescribed medication does not constitute a general generic equivalent, please explain why changing the practitioner's prescription does not violate the following prohibition in s. 465.003(13), F.S.: However, nothing in this subsection may be interpreted to permit an alteration of a prescriber's directions, the diagnosis or treatment of any disease, the initiation of any drug therapy, the practice of medicine, or the practice of osteopathic medicine, unless otherwise permitted by law. On August 14, 2006, the FMA filed its petition to challenge the proposed rule. On August 30, 2006, Mr. Dixon wrote to Ms. Printy advising that a "therapeutic equivalent" is not a "generic" equivalent." He advised that the Board was relying on the "other pharmaceutical services" portion of Section 465.003(13) as authority for the proposed rule. The Contents of the Rule There is no generally accepted definition of "therapeutic equivalent" or "therapeutic class." The proposed rule simply states: "The product that the third party formulary designates as its preferred product is a therapeutic equivalent for the prescribed product. A therapeutic equivalent is a product that is in the same therapeutic class as the prescribed drug." The Board of Pharmacy did not conduct any research or determine whether any studies existed that examined the safety, benefits or detriments of following the course of conduct permitted by the proposed rule. Likewise, no studies were conducted regarding the definition of "therapeutic equivalent." A "generically equivalent drug product" is defined by statute as "a drug product with the same active ingredient, finished dosage form, and strength." § 465.025, Fla. Stat. Section 465.025(6) allows the Boards of Pharmacy and Medicine to establish a formulary of generic drug type and brand name products which the boards determine "demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, would pose a threat to the health and safety of patients receiving prescription medication." No pharmacist may substitute a generically equivalent drug product for a prescribed name brand product, if the brand name drug or generic drug is included in the formulary established by the Boards of Medicine and Pharmacy. § 465.025(6)(b), Fla. Stat. Thus, there are instances where even drugs having the same active ingredient, finished dosage form, and strength cannot be substituted for a brand name drug prescribed by a health care practitioner. According to John O'Brien, The United States Food and Drug Administration defines "therapeutic equivalent" to mean drugs that contain the same active ingredients and route of administration and strength; and they are assigned by the FDA the same therapeutic equivalence codes starting with the letter "A." There is no indication on the record presented that the Board's definition of therapeutic equivalent, i.e., a product in the same therapeutic class, is tied to or consistent with the Food and Drug Administration's use of that term. Formularies differ based upon the third party entity developing the formulary. As a consequence, a drug may be designated as part of different therapeutic classes, depending on the persons making up the formulary. For example, the drug Digoxin is listed on the Capital Health Plan formulary as an anti-eurhythmic, while it is listed under Blue Cross Blue Shield's formulary as a cardiac glycoside. The drug can be used for both purposes. Similarly, drugs with different side effects and contra-indications may be listed under the same class under a particular formulary. There is a group of blood pressure drugs known as angiotensin receptor blockers (ARBs). These drugs have a low side effect profile. There is another group of blood pressure medications called ACE inhibitors. These drugs have a higher side effect profile than ARBs. Under Florida's Medicaid formulary, ACE inhibitors and ARBs are both in the hypotensive category of drugs, as are beta blockers. Some studies suggest that beta-blockers may either mask the symptoms of or cause diabetes. Likewise, beta blockers should not be taken by patients who have asthma. It is possible, should the proposed rule be adopted, that a physician would prescribe a drug with the chemical make-up of an ARB and check the formulary compliance box thinking only another ARB could be substituted. Florida's Medicaid formulary, however, would allow a pharmacist to substitute either an ACE inhibitor or a beta-blocker for the originally prescribed ARB. This substitution could have significant negative effects on patient care. The proposed rule also removes any requirement the pharmacist currently has to speak to the prescribing physician before substituting a drug on the compliance formulary for the drug specified by the physician. Instead, the pharmacist need only notify the physician, in writing or by facsimile, within 24 hours after the substitution, that the pharmacist has engaged in formulary compliance and what "therapeutic equivalent" has been dispensed to the patient. While pharmacies keep records regarding drugs already prescribed to patients, those records are limited to those medications dispensed by that pharmacy. They would not necessarily have access to patient records indicating problems with another drug. By the time the physician knows of a substitution made by a pharmacist, the patient may have already received, and used, a medication that is not consistent with that person's particular needs.
Findings Of Fact Background. Petitioner, George T. Lloyd, Jr., has been employed by the State of Florida, Department of Revenue, for over 14 years, and was, at all times material hereto, a participant in the State of Florida Employees Group Health Self Insurance Plan (Plan), with family coverage. On March 25, 1986, petitioner's son, George T. Lloyd, III (George), then 17 years of age and an eligible dependent under the Plan, was admitted through the emergency room to Broward General Medical Center (Hospital), Fort Lauderdale, Florida. George was placed in the Hospital's Intensive Care Unit, and remained there until his recovery and transfer to the Hospital's psychiatric floor on April 4, 1986. Upon admission, George was comatose and diagnosed as having suffered a severe barbiturate drug overdose. Blood tests performed at the time demonstrated a serum barbiturate level of 145.6 UG (milligrams per milliliter) and a serum Dilantin level of 23.3 UG. At such levels, or even one-half such levels, George would have died of respiratory depression absent medical intervention. On or about August 9, 1986, Blue Cross and Blue Shield of Florida, Inc., the State's administrator of the Plan, notified petitioner that the Hospital's statement for services and supplies rendered during the course of his son's admission of March 25, 1986 to April 4, 1986, totalling $17,402.95, was ineligible for payment based upon the Plan's exclusion of benefits for intentional self-inflicted injuries, to wit: attempted suicide. Pertinent to this case, the Plan provides: VII. EXCLUSIONS The following exclusions shall apply under the Plan: * * * E. Any services and supplies received due to the following circumstances: * * * 2. Resulting from an intentional self- inflicted injury. Over the course of the next two years petitioner's claim for such expenses was reevaluated by the Plan administrator, as well as respondent, Department of Administration (Department). At the conclusion of that review, the Plan administrator concluded that the documentation available to it demonstrated that such expenses were incurred as a consequence of George's attempt to take his own life and were therefore excluded from coverage. By letter of August 19, 1988, the Department notified petitioner that his claim for benefits arising from his son's hospital admission of March 25, 1986 to April 4, 1986, was denied because such expenses resulted from his son's attempt at suicide. Petitioner filed a timely protest of the Department's decision, and the matter was referred to the Division of Administrative Hearings to conduct a formal hearing. An Intentional Self-Inflicted Injury? Petitioner's son has a history of alcohol and drug (marijuana and cocaine) abuse and emotional problems accompanied by periods of depression that predate the incident in question by a number of years. His mother and father (petitioner) were divorced in 1971 when George was approximately three years of age. Thereafter, George resided in Florida with his mother until his fifth birthday, at which time he was sent out-of-state to reside with his father. George resided with his father until he was eleven years old, and then returned to live with his mother in Florida. In the summer of 1984, George was abusing alcohol and drugs, and experiencing difficulties in school. At that time, his mother again sent George to live with his father in the apparent hope that he could assist George in addressing these problems. The petitioner secured group counseling for George in an attempt to assist him. George continued, however, to use alcohol and drugs, and within four months, dropped out of school and ran away. Approximately four or five months later, George reappeared and returned to Fort Lauderdale to live with his mother and stepfather. Following his return, George did little of a constructive nature, and what jobs he was able to secure as a tenth grade dropout were menial in nature and of a minimal wage. Variously he worked as a bag boy, mowed lawns, and washed cars. On March 25, 1986, George was unemployed, and had just concluded an argument with his stepfather concerning his unemployment and failure to follow any constructive pursuit. Depressed at his circumstances, George ingested phenobarbital and Dilantin, drugs that had been prescribed for his stepfather, with the intention of taking his own life. But for the medical intervention previously discussed, George's attempt would have proven successful. At the time he ingested the drugs, George was not under the influence of alcohol or any other drug, and was of sufficient age and maturity to appreciate the consequences of his actions. Both the nature of the drugs he took and the vast quantity he ingested indicate an intentional attempt to take his own life rather than an accidental overdose during "recreational" use. Here, the drugs he took were not "recreational" drugs, they produce no "high," and the dosage, as heretofore noted, was massive. Considering these factors, George's admission that he attempted suicide, and the totality of the circumstances, compels the conclusion that he did consciously attempt to take his own life, and that what depression he suffered did not deprive him of the ability to appreciate the consequences of his actions.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a final order be entered dismissing, with prejudice, the petition for administrative review. DONE and ENTERED this 16th day of May 1989, in Tallahassee, Leon County, Florida. WILLIAM J. KENDRICK 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 16th day of May, 1989.
Findings Of Fact Dr. Lawrence A. Hall is licensed by the Florida State Board of Dentistry and the Hearing Officer has jurisdiction over the Respondent and the offenses alleged. During the time periods alleged Respondent smoked marijuana in the office after office hours in company with employees including a 16-year-old employee. During the time periods alleged Respondent wrote numerous prescriptions in the names of employees for controlled substances or drugs to be used for his personal use or for the use of his wife or friends. These drugs consisted of Eskatrol, Dexadrine, Dexamyl, Percodan, and Quaalude and were taken by Hall during office hours while he was performing work on dental patients. Some of these drugs made Respondent nervous and irritable and adversely affected his practice of dentistry. During the period between March, 1974 and July, 1975 Hall habitually used controlled substances add drugs. On many occasions he would be late getting to the office for morning appointments and late returning from lunch for afternoon appointments. Occasionally he would fail to come to the office at all and scheduled appointments would have to be cancelled - usually after the patient had appeared for the appointment. Hall wrote prescriptions for his wife and for his employees for controlled substances and drugs for uses not related to the practice of dentistry. These drugs consisted of amphetamines, Quaalude, and Percodan, and were often picked up from the pharmacy by one of his office employees not named in the prescription. Hall knew that his federal narcotics license did not authorize him to write prescriptions for drugs not intended for use in the practice of dentistry. Amphetamines are listed as Class II controlled substances in Chapter 893 F.S. On one occasion, while treating a small child, Hall became exasperated, threw a syringe across the room, then ran out of the office to jog around the adjacent shopping center for about 15 minutes to regain his composure. On another occasion a patient reacted adversely to an anesthetic and was thereafter properly treated by Hall to restore her breathing to normal. The dental procedure for which the anesthetic was given was then performed satisfactorily. The patient involved remained a patient of Hall until she moved to a location too far away to continue to use Hall as her dentist. She was satisfied with the dental treatment received from Hall. Hall sought help in his personal and drug related problems from his minister. No evidence was presented that Hall performed unsatisfactory dental work. To the contrary, all evidence presented in this regard was to the effect that Hall's dental work was above average. At the time of the hearing and for some months prior thereto Hall was not taking drugs.
