The Issue Whether Respondent committed the violation alleged in the Administrative Complaint, and, if so, what disciplinary action should be taken against her.
Findings Of Fact Based upon the evidence adduced at the final hearing and the record as a whole, the following findings of fact are made: Respondent is now, and has been since 1976, a Florida-licensed pharmacist. At all times material to the instant case, Respondent was employed by Eckerd Corporation as one of two full-time pharmacists assigned to the Eckerd Drug Store (Store Number 3372) located at 312 North Lake Boulevard in North Palm Beach, Florida, which housed a community pharmacy that was open 14 hours a day. Respondent and the store's other full-time pharmacist worked separate, alternating shifts. At the beginning of each shift, Respondent "signed on" the pharmacy's computer system. She "logged off" the system at the end of the shift. Respondent was responsible for the supervision of all activities in the pharmacy during her shift. Among the activities it was her responsibility to supervise were those engaged in by the pharmacy technician on duty. The pharmacy technician assisted Respondent by, among other things, preparing computer-generated prescription labels and customer receipts for prescriptions that needed to be filled. The technician prepared these items by entering the required information, including the name and strength of the prescribed medication, into the pharmacy's computer system. 1/ All prescription labels and customer receipts prepared by the pharmacy technician on duty during Respondent's shift contained Respondent's initials ("MCB"). After they were prepared, the prescription labels and customer receipts were placed in bags, and the bags were put in baskets on the counter near Respondent, where they remained until the prescriptions were filled. When filling a prescription, it was Respondent's practice to examine the actual prescription written by the prescribing physician or, in the case of an oral prescription, the pharmacy's written record of such prescription, to confirm the accuracy of the prescription information on the prescription label and customer receipt and to make sure that she was dispensing what the physician had prescribed. 2/ The pharmacy was a "very busy" one. As a result, at the end of her shift, there were sometimes prescriptions for which labels and receipts (bearing her initials) had been prepared, but which Respondent had not had the opportunity to fill, and it was not until the following shift, when she was off duty, that these prescriptions were actually filled. Respondent was on duty on June 18, 1998, when a computer-generated prescription label and customer receipt for a prescription (Prescription Number 6071853) for Patient H. V. were prepared. The computer-generated prescription label and customer receipt, which had Respondent's initials on them, indicated, among other things, that the prescription was for 15 180 milligram tablets of Thyroid and that the prescribing physician was Dr. H. Pomeranz. It is unclear when, and by whom, Prescription Number 6071853 was filled. On or about October 9, 1998, Patient H. V.'s son, R. V., filed a complaint with Petitioner alleging that "the prescription [his mother] was suppose[d] to [have] be[en] taking was 15 mil[li]grams," but she instead "was given 180 mil[lli]grams per day by [the] Eckerd Drug Store [on North Lake Boulevard]." David Dimon, a Medical Malpractice Investigator with the Agency for Health Care Administration, investigated the complaint. As part of his investigation, Mr. Dimon contacted Respondent, who advised him that she did not want to make a statement regarding the complaint. Mr. Dimon also spoke with the prescribing physician, Dr. Pomeranz, who told him that she "prescribed Thyroid, 15 milligrams, for the patient, and not the 180 milligram dose given by Eckerd Pharmacy." 3/ Dr. Pomeranz further indicated to Mr. Dimon that H. V. 4/ suffered "side effects" as a result of taking the 180 milligram tablets.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Board enter a final order dismissing the Administrative Complaint issued against Respondent in its entirety. DONE AND ENTERED this 13th day of March, 2001, in Tallahassee, Leon County, Florida. ___________________________________ STUART M. LERNER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 13th day of March, 2001.
The Issue The issue is whether Norwood Pines' annual licensure to operate an adult congregate living facility should be renewed. The Department denied renewal because of repeated failures to correct deficiencies at the facility, and due to the necessity to impose a moratorium on admissions on March 31, 1989, due to conditions at the home which threatened the health, safety, and welfare of residents.
Findings Of Fact Norwood Pines had been licensed as an Adult Congregate Living Facility (ACLF) under the "Adulte Congregate Living Facilities Act", Part II, Chapter 400, Florida Statutes. It had a licensed capacity of four beds. A survey of Norwood Pines was conducted by Lorraine Grissom, a registered nurse who serves as a senior community health nursing consultant for the Department. She regularly conducts ACLF licensure surveys. An ACLF is a home which provides housing, food service, and personal services for adults, which may include limited nursing services when the home is specifically licensed to do so. Section 400.402(2), Florida Statutes. An ACLF license is good for only one year. Section 400.417(1), Florida Statutes. At the time of the survey on March 31, 1989, four elderly women resided at the Norwood Pines ACLF: J.M., R.R., B.A.; and a fourth resident whose condition is not at issue in this proceeding. The home had been established by David Winfrey, and his wife, Barbara Winfrey, who is a registered nurse. Barbara Winfrey had been involved in the operation of the facility but had turned over responsibility for the ACLF to Mr. Winfrey. At the time of the survey on March 31, 1989, she was but of town, out of touch, and unavailable to consult with the aide at the home about problems with any of the residents. On her first visit Ms. Grissom observed one of the aides at the home was under the influence of come substance (whether alcohol or drugs could not be readily determined). The aide's gait was unsteady (she stumbled several times), her speech was slurred, and the content of her conversation was disorganized. The aides had never been given written job descriptions outlining their duties and responsibilities in providing personal care to the residents. Two residents at the ACLF were inappropriate for ACLF care. J.M. was incontinent, confused, and needed care beyond that which Norwood Pines was able to provide. Rule 10A- 5.0181(3)(a)1.e., Florida Administrative Code. B.A. was confused and disoriented; would wander outside in the rain, needed to be watched constantly; and needed to have drugs administered, because she was too disoriented to medicate herself. Rule 10A- 5.018(2)(a)4.c., Florida Administrative Code. B.A. was so disoriented that in case of fire she could not preserve herself or follow directions. Rule 10A-5.0181(2)(a)4.f., Florida Administrative Code. Food service at the home was inappropriate in that menus had not been dated and planned one week in advance, and menus were not followed in the preparation and service of food. Mr. Winfrey did not contest this survey finding, although he did maintain that residents got enough to eat. The administration of medications to residents was a severe problem at the home. There were problems with the supervision of administration of medications, the maintenance of proper medication records, and proper storage and labeling of medications. If a resident is fully capable of taking her own medication, she may purchase and maintain in her own room over- the-counter drugs such as aspirin or rolaids without a prescription, and without the necessity of a label showing the name of the resident, the name of the prescribing M.D. and instructions for the use of the medication. If the facility undertakes the responsibility for supervision of self- administered medications, staff must read the medication label to the resident when it is taken, check self-administered dosages against the label of the container, and assure that resident obtains and takes the dosage prescribed. Rules 10A-5.013(2)(jj) and 10A-5.024(1)(c), Florida Administrative Code. Medicines may be centrally stored but medicines so stored must be kept locked. Rule 10A-5.0182(3)(a)4.a., Florida Administrative Code. Resident R.R. was seen removing Excedrin from an unsecured cabinet in violation of the rule. The centrally stored medicines were not labeled with the name of the resident, the dose, the M.D. who prescribed it, and the directions for use, in violation of Rule 10A-5.0182(3)(a)5., Florida Administrative Code. A medication sheet was not kept for the medication administered to residents, contrary to Rule 10-5.024(1)(c), Florida Administrative Code. For example, resident R.R. had a prescription for 30 Tylenol #3 tablets filled on March 25, 1984. Although 5 tablets were left in the bottle on March 31, 1989, there is no indication on her medication sheet that she had been provided those tablets. This violates Rule 10A-5.0182(3)(b)2.h. and (c)1., Florida Administrative Code. In addition, there was no indication that Peri- Colace, which had been ordered by a physician for resident J.M., had been given. Staff advised Ms. Grissom that J.M. had not been given the medicine during the month of March because J.M. could not swallow it. This information was not given to J.M.'s physician. As a result, J.M. became impacted with feces. Staff was then instructed to administer Ex-lax to J.M. without a physician's order, and not to document its use on the medication sheet for J.M. Staff also gave J.M. a Fleet enema, without a physician's order. This was not proper treatment for the impaction. As a result of the impaction, JAM. had refused to eat for 2-3 days, was lethargic and was aspirating mucus. She also had difficulty breathing. The aide did not notify J.M.'s physician of this, even though her condition was a significant deviation from J.M.'s normal state of health, in violation of Rule 10A-5.0182 (1)(d), Florida Administrative Code. Resident B.A. needed to have her medication actually administered to her, rather than having supervision in taking her own medication. Staff at an ACLF may administer medication to a resident if there is a licensed RN or LPN on staff. There was no nurse at Norwood Pines to administer medication; it was done by an untrained, unlicensed aide, in violation of Rule 10A-5.0182(3)(b) and (c), Florida Administrative Code. This is especially significant because the medications involved were psychotropic drugs such as Mellaril, which the doctor ordered to be administered on an "as needed" basis for depression. This medication was given daily, because the aide did not know how to recognize behaviors which show that it was needed, something which a LPN or RN could be trained to recognize. Daily administration of Mellaril is dangerous, and contrary to the physician's instructions. The side effects of Mellaril can be severe shaking and involuntary movements, which is a particularly high risk for elderly persons, and can be irreversible. Other drugs which did appear on the medication sheets for patients on March 31, 1989, such as Lanoxin, and Haldol were not in the ACLF and therefore could not be administered as required. These violations found on March 31, 1989, had been brought to the attention of the Administrator before. Unlabeled medications, use of unlicensed staff to give medication and the lack of health assessments had been cited as deficiencies on the October 22, 1988, survey. Ms. Grissom returned on May 31, 1989, for a follow- up survey to see whether the deficiencies identified on March 31, 1989, had been corrected. All of the deficiencies remained uncorrected, including those related to proper storage, labeling, recording and supervision of the administration of medication; to the criteria for retaining residents at the home; to staff awareness of health and well-being of residents; and to provision of appropriate staff and food service. The Administrator, Mr. Winfrey, did not contest that these deficiencies had not been corrected on May 31, 1989. On May 31, 1989, Mellaril was still being given to R.R. by an untrained, unlicensed aide when the physician required that it be given on an "as needed" basis. Five hundred milligrams of calcium was being given to R.R., although the medication was unlabeled, and there was no doctor's order to provide it. A doctor had ordered that potassium be given to B.A. with plenty of water and with food, but she was given only a small amount of orange juice in a four ounce cup with the potassium. Ms. Grissom explained that it is dangerous to give potassium in a manner other than as ordered to patients with heart problems such as B.A. The medication records did not show that two other medications given for heart disease, Lanoxin and Lasix were being given daily as prescribed. B.A. was still a resident at the home on May 31, 1989, though she was still so disoriented that it was inappropriate for her to be in an ACLF. B.A. was only transferred to a facility appropriate for her care after Ms. Grissom made another visit on October 30, 1989. On May 31, 1989, staff was still unable to perform duties and ensure proper care of residents because the untrained aide was still responsible for administering psychotropic medications to residents. A final appraisal of the home was done on October 30, 1989, by Ms. Grissom. At that time, untrained, unlicensed staff was still administering medications and admitted doing so. As noted above, B.A. who was an inappropriate client, still resided at the facility. Medication records were still as inaccurate as they had been on March 31 and May 31, 1989. The daily records were not being kept as medications were given. When Ms. Grissom asked the aide for the resident's files, the aide brought menus. In short, the aide was unprepared to do those things expected of her. Health assessments for the residents were not available, although the facility had been cited for this deficiency in the October 28, 1988, survey. By the October visit, Haldol had been ordered for B.A. by her physician, to be administered "as needed," but was given as a regular dose. Mellaril, another dangerous drug, had been ordered to be given up to three times a day as needed for depression to R.R., but it was given three times a day as a regular dose, even though R.R. showed no signs of depression. None of the findings about the October 30, 1989, were controverted by Mr. Winfrey. As a result of the March 31, 1989, survey a moratorium on admissions was imposed at the Norwood Pines ACLF due to conditions which threatened the residents' health, safety, and welfare. Norwood Pines did not appeal the moratorium.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered denying the request of Norwood Pines for a renewal license to operate an Adult Congregate Living Facility. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 27th day of March, 1990. WILLIAM R. DORSEY, JR. 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 27th day of March, 1990. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 89-4346 The substance of the proposals submitted by the Department have been accepted. No proposed findings of fact were submitted by Norwood Pines. COPIES FURNISHED: Leonard T. Helfand, Esquire Department of Health and Rehabilitative Services 401 Northwest Second Avenue North Tower, Room 526 Miami, Florida 33128 David G. Winfrey Norwood Pines 19021 Northwest 10th Street Miami, Florida 33169 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 John Miller, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
The Issue The question presented in this case, is whether or not the Respondent has violated the conditions of Section 465.101(1)(e) Florida Statutes, by failing to maintain on a current basis a complete and accurate record of each controlled substance controlled by Chapter 893, Florida Statutes, in particular controlled by Section 893.07, Florida Statutes. This violation is alleged to have occurred at Washington Park Pharmacy, Inc., 750 Northwest 22 Road, Ft. Lauderdale, Florida. The alleged violation was noted by V. K. Bell, agent, Florida Board of Pharmacy, based upon a drug accountability audit which covered the period from September 1, 1976 to October 3, 1977.
Findings Of Fact This cause comes on for consideration based upon the complaint and notice to show cause brought by the Petitioner, Florida Board of Pharmacy, in an action against James R. Gibbons, who is licensed to practice pharmacy by the Petitioner. The action charges that James R. Gibbons, while licensed to practice pharmacy in the State of Florida, violated the provisions of Section 465.101(1)(e), Florida Statutes. This claim of violation is premised upon the alleged failure of the Respondent, James R. Gibbons, to comply with the conditions of Section 893.07, Florida Statutes, in that the Respondent permitted the improper keeping of records, by failing to maintain on a current basis a complete and accurate record of each controlled substance controlled by Chapter 893, Florida Statutes. This failure of control was alleged to have occurred at the Washington Park Pharmacy, Inc., at 750 Northwest 22 Road, Ft. Lauderdale, Florida. The prosecution is grounded on the investigation performed by V. K. Bell, agent, of the Petitioner and specifically arises from a drug accountability audit which covered the period from September 1, 1976 till October 3, 1977. As a part of his duties, agent V. K. Bell, an employee with the Florida Board of Pharmacy, conducted an audit of the Washington Park Pharmacy, Inc., located at 750 Northwest 22 Road, Ft. Lauderdale, Florida. The period of the audit covered September 1, 1976 through October 3, 1977. An element of the audit concerned the class II drugs, Dilaudid, 4mg. tablets and Quaalude, 300mg. tablets. A synopsis or summary of the audit process pertaining to the two drugs by weight, may be found as Petitioner's Exhibit #1, admitted into evidence. In that audit report, agent Bell has broken down the amounts of the questioned drugs into categories. These categories begin with a zero initial inventory on September 1, 1976 and report the total number of tablets purchased; the amount of ending inventory; the amount of sales by prescription, both legitimate and possible forgeries; the amount of loses by theft; and the amount short, for which there is allegedly no explanation. By the figures reported by agent Bell; 59,100 Dilaudid 4mg. tablets were purchased in the audit period; 200 tablets remained as ending inventory; 49,869 tablets were reported as sales or loss by theft; and 9,031 tablets were reported short. Looking at the report rendered by agent Bell on the substance Quaalude, 300 mg. tablets, it shows a total purchase within the inventory period of 32,200; an ending inventory of 50; sales of 25,421 by prescription; and 6,729 tablets short. The Respondent has taken issue with the statistical data offered by the Petitioner. In its argument against the case of the Petitioner, the Respondent has offered Respondent's Exhibits 5 & 6, admitted into evidence. These exhibits are respectively a compilation of the sales made to the Respondent by the Gulf Drug Company and Crandon Drugs, Inc. The tapes which are attached to those exhibits act as a take-off in adding the amounts of the two questioned substances, and show that 54,200 Dilaudid 4mg. tablets were purchased during the audit period and 29,700 Quaalude 300mg. tablets were purchased during the audit period, according to the computations of the Respondent, James R. Gibbons. Gibbons also takes issue with the allegation found in the audit summary, to the effect that certain prescriptions were forged by the doctors listed. The depositions of Drs. Collier, Cohen, Morris, and Walker were taken prior to the hearing. Those depositions have been admitted into the record in lieu of testimony at the hearing. The deposition of David Collier, D.O., shows that during the audit period, he wasn't treating the patients who needed the two drugs Dilaudid and Quaalude. He did indicate that at one time he had left prescription pads in the treatment rooms where someone may have picked those prescription pads up. However, he denies signing any prescriptions which were shown to him and alleged to have been under his signature. He thereby states that those prescriptions are forgeries. He also denied that any prescription forms with the name Washington Park Pharmacy had been provided to him. Dr. Collier's partner for a time, was Bernard Cohen, D.O. Dr. Cohen states that he wrote prescriptions for Quaalude and Dilaudid in November, 1975, but not on pads from Washington Park Pharmacy. He also admitted that employees within his office other than he and Dr. Collier had access to the prescription pads. He recalls that during the audit period one patient was on Dilaudid and one patient was receiving Quaalude. The writing exemplars that were shown to him which are prescriptions allegedly written by him were felt to be forgeries, with the exception of his patients which he identified as his. From his recollection the Washington Park Pharmacy never called about any alleged forgeries that may have been received bearing his name. The deposition of William A. Morris, III, M.D. establishes that he has prescribed Dilaudid and Quaalude, but not in the amounts attributed to him in the audit. He also stated that in February, 1976, there was a "break-in" and certain prescription pads were missing. The signature on the exemplars shown to him were felt to be similar to his signature; however, he did not recognize any of the names to be his patients and therefore felt that the substance of the prescription was a forgery. The deposition of Dr. Thomas J. Walker, M.D., establishes that he was not prescribing the drugs Dilaudid and Quaalude at the time of the audit. After looking at the exemplars of the prescriptions presented him he stated that those prescriptions had not been written by him. In his estimation, the prescription pads in his office were secure during the audit period and no "break-ins" or thefts had occurred. The explanation which the Respondent gave on the question of any possible forgeries was to the effect that he has a duty to fill the prescriptions which are tendered to him by a treating physician, and further that his practice is to notify the alleged treating physician when there is some question about the authenticity of the prescription given to him by a customer. The Respondent's explanation for any shortage of prescriptions during the audit period was to the effect that either the agent for the petitioner or the representatives of the United States Drug Enforcement Authority had lost some of the records in transporting his books and records to their office for examination; or in the alternative those records still regained in his pharmacy and were undiscovered by the Petitioner's representative and representatives of the Drug Enforcement Authority. The positions of the parties should be examined in view of the requirements of the law under which the charge is brought. Section 465.101(1)(e), Florida Statutes, reads as follows: 465.101 Authority to revoke or suspend licenses.- (1) The Board of Pharmacy may revoke or sus- pend the license and registration certificate of any registered pharmacist, after giving such pharmacist reasonable notice and an opportunity to be heard, who shall have: * * * (e) Violated any of the requirements of this chapter, of chapter 500, known as the "Florida Food, Drug, and Cosmetic Law," of ss. 301 through 392 of Title 21, United States Code, known as the "Federal Food, Drug and Cosmetic Act," or of chapter 893. By this charging document, the Petitioner is claiming that the Respondents have violated Section 893.07, Florida Statutes. A portion of that section is Section 893.07(3), Florida Statutes, which calls for the record of all controlled substances sold, administered, dispensed, or otherwise disposed of to be kept; to the extent of among other things, showing the kind and quantity of controlled substances sold, administered, or dispensed. Section 893.07(4), Florida Statutes, also states that these records shall be kept and made available for a period of at least two years for inspection and copying by law enforcement officials. Section 893.07(5), Florida Statutes, calls for the maintenance of records of any substances lost, destroyed or stolen, as to the kind and quantity of such controlled substances and the date of discovery of the loss, destruction or theft. In reviewing the facts offered into evidence at the hearing, in the context of the position taken by the Petitioner at that hearing, it appears that the Petitioner is most concerned with the shortages, as opposed to the questioned prescriptions which they feel might be forgeries. Moreover, the facts establish that there was a "break-in" on August 30, 1977, in which the Respondent, James R. Gibbons' inventory showed that 128 Dilaudid 4mg. tablets were stolen or missing, for which the Petitioner gives credit in the audit process. Therefore, the analysis to be given this case will center on the "so- called" shortages of the two substances. The undersigned has reviewed the Exhibits 5 & 6 by the Respondent and finds the computations of the Respondent to be incorrect. An examination of those exhibits shows that 55,400 Dilaudid 4mg. tablets were purchased in the audit period and 30,200 Quaalude 300mg. tablets were purchased in the audit period. Using those figures, and subtracting the amount of tablets dispensed by prescriptions or lost through theft, to include questioned prescriptions, it shows 5,531 Dilaudid 4mg. tablets are short and 4,779 Quaalude 300mg. tablets are short. These shortages are shortages in which no meaningful explanation has been offered. The substances Dilaudid and Quaalude are class II drugs, for which records must be kept in a manner described above, in keeping with Section 893.07, Florida Statutes. The Respondent, James R. Gibbons, has failed to maintain the records in accordance with Section 893.07, Florida Statutes, and has thereby violated Section 465.101(1)(e), Florida Statutes.
Recommendation It is recommended that the license and registration certificate of James R. Gibbons, to be a pharmacist in the State of Florida, be revoked. DONE AND ENTERED this 5th day of April, 1977, in Tallahassee, Florida. CHARLES C. ADAMS Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Robert A. Pierce, Esquire Suite 201 Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 W. George Allen, Esquire 116 Southeast Sixth Court Post Office Box 14738 Ft. Lauderdale, Florida 33302
Findings Of Fact At all pertinent times, respondent Margie V. Gray Denomme worked the 3- to-11 shift as a licensed practical nurse on the orthopedic floor, 3 North, of West Florida Hospital, in Pensacola. On or about September 9, 1980, respondent was counseled for failing to record the administration of Stadol and Demerol, controlled substances, "on MAR." Petitioner's Exhibit No. 2. CHART NO. 670613 On December 19, 1980, Dr. Hooper ordered, inter alia, 10 to 12 milligrams of morphine sulfate for a patient (Chart No. 670613) "q 3-4 hrs prn pain." Petitioner's Exhibit No. 1. According to a Narcotics and Controlled Drug Administration Record, Petitioner's Exhibit No. 2, respondent administered 10 milligrams of a 15-milligram tubex of morphine (sulfate) to the patient at five o'clock on the afternoon of December 26, 1980, and wasted the other five milligrams, the wastage being witnessed by another licensed practical nurse, Ms. Grant. The December 26, 1980, patient progress notes for the patient, Petitioner's Exhibit No. 1, contain an entry reflecting administration of medication at five o'clock in the afternoon: [complaining] o[f] pain, medicated [with] M[orphine] S[ulfate] 10 mg IM . . . as stated by M. Denomme LPN." The entry is signed, "G. Grant LPN." The PRN medication administration record for this patient was signed by "G. Grant LPN" for the 3-to-11 shift on December 26, 1980. Petitioner's Exhibit No. 1. CHART NO. 667312 On December 17, 1980, Dr. Batson ordered morphine sulfate for this patient "1/4 to 1/6 IM q 34 PRN Pain." Petitioner's Exhibit No. 1. At quarter of seven on the evening of December 17, 1980, respondent administered 15 milligrams of morphine sulfate to the patient, using one 10-milligram tubex and half of another, the wastage being witnessed by another licensed practical nurse, Ms. Grant, all according to the Narcotics and Controlled Drug Administration Record. Petitioner's Exhibit No. 2. "v. Robertson, GPN" signed the patient's PRN medication administration record for the 3-to-11 shift on December 17, 1980. Petitioner's Exhibit No. 1. The nurses' notes contain this entry for 6:45 (pm.): "c/o pain-Medicated E MS 15 mg IM as stated by V. Robertson GPN-G. Grant GPN." CHART NO. 67194-3 For this patient, Dr. Batson ordered, among other things, "Morphine gr 1/6-gr 1/4 IM q 3-4 h prn pain. or Demerol 50-75-100 mg q 3-4 h IM prn pain. Tylenol #3 po T-TT q 3-4 h prn pain" on December 17, 1980, the date of his admission to West Florida Hospital's orthopedic ward. At half past six on the evening of December 17, 1980, the patient was given two tablets of Tylenol #3. Petitioner's Exhibit No. 1. He got another two tablets of Tylenol #3 about noon the following day. Petitioner's Exhibit No. 1. On December 19, 1980, Randy Godwin, a licensed practical nurse at West Florida Hospital, signed a Narcotics and Controlled Drug Administration Record indicating he had administered 15 milligrams of morphine to the patient at 6:20 p.m. Petitioner's Exhibit No. 2. Attached to this Narcotics and Controlled Drug Administration Record is an interoffice memorandum to the hospital pharmacy from Cynthia Ayres, R.N., Assistant Director of Nursing. Ms. Ayres wrote, "I have met with Randy Godwin, LPN and discussed his specific narcotic errors. He was terminated from employment at WFH. I did not allow him to correct these errors." Petitioner's Exhibit No. 2. There is no indication on this patient's PRN medication administration record that he was given any morphine on December 19, 1980. Petitioner's Exhibit No. 1. No administration of morphine on December 19, 1980, was charted in the patient's progress notes. Petitioner's Exhibit No. 1. Respondent administered 75 milligrams of Demerol, the entire contents of a tubex, to this patient at half past seven on the evening of December 19, 1980, according to a Narcotics and Controlled Drug Administration Record. Petitioner's Exhibit No. 2. (Count II) At nine o'clock that night, the patient was watching television, and had no complaint of pain. JANUARY 24, 1981 As she administered narcotics to patients during the 3-to-11 shift on January 24, 1981, respondent dropped waste paper and other debris in the narcotics drawer of the medication cart she had charge of. Toward the end of the shift, she was in the process of cleaning out the narcotics drawer when she felt something wet. Exclaiming something like, "Oh God, look at this," (T. 156; Testimony of Peat), she retrieved a cardboard container soaked to the point of disintegration with a solution of morphine sulfate, in the presence of Sandra Jean Peat, Randy Godwin, and other nurses who were in the medical room on the orthopedic floor at the time. Respondent recorded these events in an incident report and took the five-tubex plastic sleeve to the hospital pharmacy, about quarter of eleven. She asked the hospital pharmacist, James Thomas Allred, "to swap them out for five good ones." (T. 88.) At Mr. Allred's request, respondent prepared a second incident report in which she stated: When I was cleaning the Narcotics drawer, I picked up some of the packages and felt moisture on my hands. I then took the cartridges out of the PCK & found solution in bottom of Plastic Jacket. Two cartridges had the stopper out & 1 cartridge was broken. The tabs were intact as wit- nessed by R. Godwin LPN. Petitioner's Exhibit No. 3. After the wet plastic sleeve had been exchanged for a new one, respondent returned to the floor to catch up on charting. By this time, Randy Godwin had left the hospital. Mr. Allred jotted down his own contemporaneous account on the Narcotics and Controlled Drug Administration Record: Replaced a packet of five morphine sulfate 15 mgs. for a packet of five returned by M. Denomme LPN. The packet returned had two syringes with their rubber plungers out. One of these two syringes was broken. All tabs were intact except for the broken syringe. The cart count will remain the same. Petitioner's Exhibit No. 2. When respondent noticed broken glass in the five-tubex plastic sleeve, after another nurse had seen the sleeve with all tabs intact but before respondent took it to the pharmacy, she opened a tab to fish out syringe shards. The evidence clearly and convincingly established that somebody tampered with more than one of the disposable syringes or tubexes inside the plastic sleeve. Although factory defects . . . do occur, this was not a case of defective manufacture; a needle had punctured the sleeve. As the medication nurse for the 3-to-11 shift, respondent had signed for the narcotics and controlled drugs in the medication cart and taken the keys at three o'clock on the afternoon of January 24, 1981. Petitioner's Exhibit No. When she counted narcotics, before assuming responsibility for them, respondent did not pick up each item. Looking down into the narcotics drawer, she would not necessarily have known whether the bottom of the cardboard container holding two plastic sleeves, each of which contained five 15-milligram tubexes of morphine sulfate, was wet. Respondent was the third person to sign the Narcotics and Controlled Drug Administration Record as "oncoming nurse." Petitioner's Exhibit No. 2. She had the keys to the medication cart during the entire 3-to-11 shift except when she went to supper or took a break. No patient on the orthopedic floor received any morphine sulfate during the whole 24-hour-period. CHART NO. 682231 Also on January 24, 1981, respondent administered two tablets of Tylenol #3 to this patient at 5:30 and another two tablets of Tylenol #3 at 9:35, according to a Narcotics and Controlled Drug Administration Record. Petitioner's Exhibit No. 2. This "patient had been medicated with Tylenol #3 since January 20th, and this medication had held her . . . for a period of at least four hours." (T. 55.) Respondent signed out for 75 milligrams of Demerol for this patient but wasted it, in the presence of Randy Godwin. Randy Godwin did not sign the Narcotics and Controlled Drug Administration Record as a witness, however. OTHER MATTERS There was absolutely no evidence that respondent acted strangely or as if under the influence of a controlled substance at any time between September, 1980, and February, 1981. No evidence was adduced regarding anything that happened on or about February 8, 1981. On or about January 30, 1981, Altha Steen Chandler, then a ward clerk on the 3-to-11 shift for the orthopedic floor, told Gail Price that, two weeks earlier, while cleaning in the conference room, she had knocked respondent's purse off a table; that the purse opened when it fell; and that she saw containers of codeine, Demerol, and Benadryl. On hearing this, Ms. Price promptly relayed it to Bonnie Ellen Ripstein, then departmental nursing supervisor over surgical floors. The truth of this allegation, repeated under oath at the hearing (T. 5), was not clearly and convincingly established, considering all the evidence. There was no proof that any codeine was ever missing or unaccounted for at West Florida Hospital at any time between September of 1980 and February of 1981. The only record keeping irregularity with which respondent has been charged regarding Demerol has to do with records kept on January 24, 1981, after the ward clerk claims to have seen a vial of Demerol in her purse. The substances themselves were not in evidence. Ms. Chandler's testimony about their packaging was contradictory: "The demerol and the codeine was in a plastic like container and had red writing on it. The benadryl was in a brown container, and it had yellow writing on it . . . . The benadryl was a glass vial, but the other two vials, seemed like they were plastic to me." (T. 16.) Respondent admits that she regularly carries a vial of Benadryl in her purse; she testified that she is allergic to bee stings. She denied that there was codeine or Demerol in her purse on or about January 16, 1981, and claimed to be allergic both to codeine and to Demerol. At some point,, Ms. Ripstein was given the assignment of auditing narcotics records with which respondent, Randy Godwin, Nancy Torch, and Debra Mann, now Rezzarday, had been involved. None of the four is now employed at West Florida Hospital. This audit turned up most of the charges made against respondent in these proceedings. STANDARDS AND CONDITIONS The nurses at West Florida Hospital were strongly encouraged to finish their duties before shift's end to avoid their employer's having to pay overtime wages. Once, when respondent stayed late to finish her charting, she was reprimanded even though she had clocked out. On the orthopedic floor, a nurse who was "caught up" with her work would chart for other nurses who were busy, indicating on the records that she was relying on oral representations of another nurse. This practice was against hospital policy and does not conform to minimal standards of acceptable and prevailing nursing practice. It is also a departure from minimal standards to waste a controlled substance like Demerol without a witness's signing the control sheet at the time the drug is wasted. It was not shown that any patient suffered any injury at respondent's hands or on her account. The written closing argument of respondent and petitioner's proposed recommended order have been considered in preparation of the foregoing findings of fact. Petitioner's proposed findings of fact have been adopted in substance, except where unsupported by clear and convincing evidence.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner suspend respondent's license for thirty days. DONE AND ENTERED this 28th day of June, 1982, in Tallahassee, Florida. ROBERT T. BENTON, II 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 28th day of June, 1982. COPIES FURNISHED: W. Douglas Moody, Jr., Esquire Samuel R. Shorstein, Secretary 119 North Monroe Street Department of Professional Tallahassee, Florida 32301 Regulation 130 North Monroe Street Allen W. Lindsay, Jr., Esquire Tallahassee, Florida 32301 Post Office Box 586 Milton, Florida 32570 Helen P. Keefe Executive Director Board of Nursing 111 East Coastline Drive Jacksonville, Florida 32202
The Issue Whether disciplinary action should be taken against Respondent's license to practice medicine based on: The allegations of the Administrative Complaint in DOAH Case No. 97-3363, pertaining to patient R.W., of violations of Sections 458.331(1)(q), Florida Statutes, [failure to appropriately prescribe in the best interest of the patient]; 458.331(1)(t), Florida Statutes, [failure to practice 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]; and Section 458.331(1)(m), Florida Statutes, [failure to keep medical records justifying the course of treatment of the patient during his care of the patient]; and The allegations of the Administrative Complaint in DOAH Case No. 97-3442, pertaining to patient N.W., of violating Section 458.331(1)(t), Florida Statutes, [failure to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances].
Findings Of Fact Respondent is a licensed medical physician in the State of Florida and has been licensed in Florida at all times material under license number ME0041782. Respondent is Board-certified in internal medicine, and his area of specialty is pulmonary medicine. AHCA Case No. 95-5043; DOAH Case No. 97-3442; Patient R.W. On or about November 5, 1990, Patient Mr. R.W. suffered a work-related accident resulting in a very significant injury to his back, including a complete disc herniation. On November 10, 1990, orthopedic surgeon Georges El Bahri, M.D., performed major spinal surgery, including a complete laminectomy of L4, L5, disc excision of L5, S1, and exploratory surgery in the region of S1 on R.W. at Memorial Medical Center in Jacksonville, Florida. This surgery was of an emergency nature to prevent paraplegia. Prior to this surgery, R.W. was referred by Dr. El Bahri to Respondent on a pulmonary consult for surgical clearance because R.W. was suffering from chronic pulmonary disease, (CPD). R.W. experienced genitourinary dysfunction (a dysfunction of the genitalia or urinary organs) as a result of his accident, and he saw a urologist, Mohammed N. Mona, M.D., for treatment. On November 22, 1990, a second surgery was required for removal of a previously unidentified disc fragment. Dr. El Bahri recommended a spinal fusion. Evaluation by a second orthopedic surgeon indicated that R.W. had suffered a 30 percent disability of the body as a whole related to his orthopedic injuries. The second orthopedic surgeon also suggested a bone fusion. A spinal fusion operation would have exposed R.W. to a risk of loss of lower body function, and he declined the operation. Dr. El Bahri referred R.W. to Respondent to provide continuing care for R.W.'s pulmonary problem. Without surgery, R.W.'s back pain would continue to be severe and intractable. Dr. El Bahri had tried multiple alternative modalities of pain management with R.W. during the period of time that he participated in R.W.'s care, including use of a cane, weight reduction, corset, body brace, physical therapy, and a transcutaneous epidural nerve stimulator unit (TENS). Dr. El Bahri also had prescribed pain mediation for R.W. An implanted nerve stimulation device had been recommended, but R.W. declined it. Dr. El Bahri and Respondent consulted concerning efforts to control R.W.'s pain. Dr. El Bahri made Respondent aware of the various alternative pain modalities that he had tried. At some point, it was agreed between Dr. El Bahri and Respondent that where there is intractable pain requiring prescription drugs, one physician should assume primary care. Dr. El Bahri, as the orthopedic surgeon who could not get R.W. to agree to further surgery, deferred to Respondent who was treating R.W.'s chronic pulmonary problems. Dr. El Bahri and Respondent agreed that Respondent would prescribe analgesic and other medications for management of R.W.'s intractable pain. R.W.'s first office visit with Respondent was on May 3, 1991, and his last office visit was on June 16, 1993. Petitioner alleged violations by Respondent both as to level of care and the keeping of medical records because he did not perform and record a full physical for R.W. at or about the time of R.W.'s first office visit. However, Dr. Harvey, testifying on behalf of Petitioner, as well as Dr. Corral, testifying on behalf of Respondent, agreed that it would not be necessary for Respondent to repeat a complete history and physical on R.W. between the November 1990 hospital consultation and physical and the May 3, 1991, office visit. Dr. Harvey would have allowed a ten-month delay, and Dr. Corral felt no further complete physical was necessary for treatment of a chronic condition so long as there was evidence of frequent office visit evaluations. All the medical expert witnesses faulted Respondent's office records if they did not physically contain the hospital consultation sheets, and there is reason to believe that Respondent's office records did not include the consultation sheets until after R.W.'s death. Likewise, I do not find the other, later brief notes in Respondent's office records of partial examinations by Respondent or by his Physician's Assistant to constitute sufficient alternative documentation under the circumstances. See, infra. Therefore, to this degree, Respondent's records did not justify his course of treatment of R.W. R.W. presented to Respondent with multiple problems: intractable back pain secondary to his injuries, chronic obstructive pulmonary disease (CPD-COPD), a history of smoking a pack and a half of cigarettes every day for 25 years, impotency, back surgery, hyperlipidemia, and labile hypertension. "Hyperlipidemia" means high cholesterol and trigylcerides. "Labile hypertension" refers to erratic high blood pressure. At 205 pounds, R.W. also was overweight, but not "morbidly obese" for his height and age. While under Respondent's care, R.W. continued to suffer from intractable back pain secondary to his injury, anxiety, and situational depression. On April 10, 1992, while under Respondent's care, R.W. underwent a psychiatric evaluation at the University of Florida Health Sciences Center in Jacksonville, Florida. The psychiatrist, Ernest C. Miller, M.D., prepared a report dated June 9, 1992, in which he indicated that R.W. suffered adult situational disorder with chronic depression. He recommended "psychiatric contact." Respondent facilitated the workers' compensation insurance carrier's referral of R.W. to the psychiatrist for evaluation. Respondent's office records are deficient on this matter, but it appears most likely from the evidence as a whole that R.W. did not follow up on the psychiatrist's recommendation for psychiatric counseling because his workers' compensation employer-carrier declined to pay for any further psychiatric care. Although Dr. Harvey testified that Respondent should have tried to talk R.W. into psychiatric counseling, the evidence as a whole falls short of demonstrating that Respondent bore any professional responsibility to force R.W. into psychiatric care or counseling against R.W.'s will and at R.W.'s own expense. The psychiatrist recommended tricyclic anti- depressants. Respondent prescribed tricyclic anti-depressants as well as other drugs described infra. Respondent obtained consultations of specialists, including two orthopedic physicians and a neurosurgeon. Respondent also tried additional alternative modalities of pain management, including Marcaine (analgesic) trigger point injections, and topical anesthetics. Despite Petitioner's charge that Respondent's care of R.W. was substandard due to his failure to refer R.W. to a pain management specialist, I find that between Dr. El Bahri and Respondent, most acceptable pain management modalities were attempted with R.W, and Respondent's failure to refer R.W. to a pain management specialist did not fall below the professional standard of care. In making this finding of fact, I have given weighted consideration to Dr. Harvey's testimony that there was no other pain management besides drugs unless Respondent could talk R.W. into psychiatric counseling or surgery, or retrying a TENS unit, and to Dr. Corral's testimony that it was not necessary for Respondent to consult with a pain specialist because the patient had refused all invasive and some non- invasive pain management and that anything other than invasive pain management could be done for R.W. by the Respondent. During the period of time R.W. was under Respondent's care, Respondent prescribed to him analgesic medications for pain. He also prescribed anti-depressant, anti-anxiety, and muscle relaxant medications. It is with the quantity of these prescriptions, the inter-action of the drugs prescribed, and the failure to record these prescriptions in Respondent's office records for R.W. that the Petitioner finds fault. Between April 21, 1992, and July 6, 1993, Respondent wrote R.W. in excess of 30 prescriptions for pain management and depression. Dispensation of these prescriptions, including approved refills, exceeded 4,000 tablets. However, during this period of time, Respondent also recorded 11 office visits: 4/21/92, 5/15/92, 5/18/92, 5/20/92, 6/18/92, 8/21/92, 11/9/92, 2/1/93, 4/5/93, 5/4/93, and 6/16/93. Based on a "Pharmacy Profile," R.W. received the following medications prescribed by Respondent between April 21, 1992, and July 6, 1993. Drug Prescribed Dosage/Quantity Dates Filled Diazepam 10mg 50 06/16/93 Amitriptyline 50mg 30 07/24/92 50mg 30 08/11/92 50mg 30 09/23/92 50mg 30 10/20/92 50mg 30 11/20/92 50mg 30 12/16/92 100mg 30 02/01/93 100mg 30 03/03/93 100mg 30 04/02/93 100mg 30 05/03/93 150mg 30 05/07/93 100mg 30 06/02/93 100mg 30 06/25/93 Drug Prescribed Dosage/Quantity Dates Filled Lorcet Plus 100 06/18/92 100 07/15/92 100 08/11/92 90 09/11/92 90 10/07/92 90 11/09/92 90 12/07/92 90 12/31/92 90 01/29/93 100 03/01/93 100 04/02/93 100 05/03/93 100 05/07/93 100 06/07/93 100 07/06/93 Roxicet 5/325 40 04/05/93 Clorazepate 100 04/05/93 Xanax 1mg 100 04/22/92 100 05/26/92 100 07/09/92 100 08/11/92 100 10/07/92 100 11/09/92 100 12/07/92 100 12/31/92 100 01/29/93 100 03/01/93 100 04/02/93 100 05/03/93 100 06/07/93 100 07/06/93 Acetaminophen 500mg 100 09/11/92 100 10/20/92 100 11/20/92 100 12/05/92 100 02/10/93 Notriptyline 50mg 120 09/11/92 120 10/20/92 120 01/18/93 Carisoprodol 350mg 100 05/07/93 100 07/06/93 Xanax, Lorcet Plus, Amitriptyline, Clorazepate, Roxicet, Diazepam, and Carisoprodol are Central Nervous System (CNS) depressants and several, including Xanax and Diazepam (Valium), are benzodiazepines. When taken together, CNS depressants can produce additive CNS effects. Benzodiazepines are drugs which are in a class of structurally related compounds. They have sedative, anti- convulsant, and skeletal muscle relaxant properties and are used for the treatment of anxiety and other purposes. Using several benzodiazepines together can also be fatal, because the patient may develop a tolerance to the drug and ultimately consume toxic dosages. Xanax is a Schedule IV legend drug used to treat anxiety disorders. It produces additive CNS depressant effects when administered with other CNS depressants. Lorcet Plus is a Schedule III legend drug which contains Hydrocodone. It is used for treating moderate to moderately severe pain. If used with other CNS depressants, it can produce additive CNS depression. Amitriptyline is a legend drug and a trycyclic anti- depressant. It can enhance the effects of alcohol, barbiturates, and CNS depressants. It can aggravate heart conditions. Clorazepate is a Schedule IV benzodiazepine legend drug indicated for the treatment of anxiety disorders. It has a CNS effect. Clorazepate should not be administered to patients with indications of drug dependencies. Roxicet is a Schedule II legend drug which has a high potential for abuse and has a currently accepted, but severely restricted, medical use. It can produce dependency of the morphine type. Diazepam is a Schedule IV drug indicated for the treatment of anxiety disorder. It is a form of Valium and is a CNS depressant. Nortriptyline is a legend drug that is a tricyclic anti-depressant. Carisoprodol is a legend drug that is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. It is a CNS depressant. R.W. died unexpectedly at his home on July 9, 1993. Petitioner contends that because the prescribed medications were not listed in R.W.'s chart at the material times, the prescriptions and renewals were given by Respondent without any reference to a medical record which would allow Respondent or any physician to provide R.W. with sufficient warnings or information regarding the combined use of these drugs and/or to appropriately monitor or limit R.W.'s simultaneous intake of the CNS depressants, and that, whether one concludes that R.W. died due to multiple drug toxicity or as a result of a myocardial infarction is not critical, but that Respondent's care and treatment was so careless as to create an environment in which R.W. was an "accident waiting to happen." All the testifying medical experts agreed that Respondent should have given R.W. medication overdose and interaction warnings. Respondent claims to have orally warned R.W. and R.W.'s wife concerning R.W.'s prescriptions, but it is not disputed that prior to R.W.'s death, R.W.'s chart/medical records in Respondent's office did not contain adequate notations of oral medication overdose and interaction warnings. Dr. Corral testified that not all such warnings must be recorded. It is also undisputed that prior to R.W.'s death, his chart/records in Respondent's office did not contain adequate notes on the drugs prescribed by Respondent. In his office practice, Respondent had established a system whereby requests for refills of medications previously prescribed to patients would be documented on a separate IO9 drug tally sheet or "day sheet" by Respondent's staff. Sometime during each work day, Respondent would review the list of requested refills, and approve or deny each by making a written notation on the "day sheet." Respondent's staff would then telephonically authorize the pharmacy to refill only those prescriptions that Respondent had authorized in writing. By making a written notation approving requested refills, Respondent was creating a record of drugs he prescribed. Under Respondent's system, his staff members were then supposed to transpose the refill information from the "day sheet" onto each patient's individual medical record chart. The aforementioned system for approval of requested refills and documentation thereof is an acceptable means of documenting refill information on medications for individual patient charts, but it was not followed in this instance. Vickie Browning, as receptionist and "front office" staff member, was primarily responsible for the transfer of the medication information from the day sheets to individual patient charts. Periodically, when she got backed up with telephone calls or otherwise behind in her work, Ms. Browning simply threw away piled-up day sheets without transferring the prescription information to individual patient charts. In making this finding of fact, I have noted the clear testimony of another staff member, Angie McKenzie, who saw Ms. Browning throw away a pile of prescription day sheets, but who admittedly did not advise Respondent of what was going on. I also have considered Linda Eady Turner's testimony that Ms. Turner saw a pile of day sheets in the trash can on a single occasion. I also have carefully scrutinized Ms. Browning's testimony, which by candor and demeanor, internal inconsistencies, and motivation to fabricate, I find to be unreliable and incredible. Despite R.W.'s 11 office visits during the material period of time, during each of which Respondent presumably reviewed R.W.'s chart, Respondent did not become aware that prescription refill information was not being recorded in R.W.'s chart. Likewise, Respondent did not become aware that prescription refill information was not being recorded in any patient charts until he reviewed R.W.'s medical chart after R.W.'s death. As the medical professional ultimately responsible for accuracy of medical records and treatment of his patients, Respondent should have noted the gaps on R.W.'s and other patients' charts before he did. For the same reasons, he should have known, prior to R.W.'s death, that his system was not being followed. After R.W.'s death, the Duval County Medical Examiner confiscated drugs from R.W.'s home and created a Medication Log containing the following drugs: Xanax 1 mg, 1-1/2 pills remaining; Amitriptyline 150 mg, 1 remaining; Amitriptyline 100 mg, 8 remaining; Ketoproten 75 mg, 61 remaining, Zantac 150 mg, 1 remaining; Amoxicillin 500 mg, 1 remaining; Helotestin 10 mg, 9 remaining; Lorcet Plus tablets, 88 remaining; Carisoprodol 350 mg, 54 remaining; Xanax 1 mg, 88-1/2 remaining; Carisoprodol 350 mg, 97 remaining; and Hydrocodone, 27 remaining. All of these drugs were prescribed by Respondent. Laboratory tests performed on R.W. revealed the presence of Amitriptyline, Hydrocodone, Nordiazepam (which is from Diazepam), Carisoprodol, and Xanax. Respondent was quickly embroiled in legal actions arising out of R.W.'s death. Upon discovering that prescription refill information relating to R.W. had not been recorded by his staff on R.W.'s chart, Respondent instructed members of his staff to obtain prescription information from the pharmacy, and recreate a medication list for R.W.'s chart. He further advised his staff to record any recollections they had which related to interactions of any staff members and R.W. or R.W.'s wife. Once his staff had completed the prescription information recreation, Respondent placed a note on the recreated records, identifying them as recreations and not contemporaneous notes. He also advised his attorney and the attorney representing the estate of R.W. of the recreated records. This would logically show no intent to, or conspiracy by, Respondent to fabricate or falsify patient records, but merely an intent and effort to recreate prescription information for his defense at trial. In making this finding of fact, I have again discounted Ms. Browning's testimony for the reasons previously cited. All testifying medical experts agreed that it is professionally acceptable for a medical physician to add notes as an addendum, provided the physician indicates the date of additional notes and clearly shows that they are not contemporaneous. At the request of one of R.W.'s relatives employed in the Sheriff's Office, the Assistant Medical Examiner for Duval County, Dr. Bonafacio Floro, performed an autopsy on R.W.'s corpse. He opined that the immediate cause of R.W.'s death was "multiple drug toxicity," although he noted "arteriosclerotic disease" as a secondary, or contributing, cause of death. He also speculated that one or more prescription drugs could have caused a myocardial infarction. In formulating his opinion on the proximate cause of R.W.'s death, Dr. Floro relied almost exclusively on laboratory tests performed by the Duval County Medical Examiner's Office and by an outside laboratory revealing the presence of several drugs in R.W.'s blood. The results of the drug tests performed by the Duval County Medical Examiner's Office and the outside laboratory are inconsistent, but this is largely a difference without a distinction. By either test, R.W.'s blood level of Hydrocodone would be "lethal" as established by a generally accepted medical text, and his blood level of Xanax would be "toxic" as established by the same generally accepted medical text. This medical text, however, is basically only a catalogue of drug toxicity levels in persons already dead. According to Dr. Venard Adams, however, all of the drugs in R.W.'s blood at the time of his death were at therapeutic levels, except for Hydrocodone, which was at the low end of the generally accepted lethal range, and this level might not be lethal for one who had developed a tolerance for several drugs. Dr. Adams's opinion on this score was shared by Dr. Thomas F. Hegert. Each of these physicians are also Florida Medical Examiners. Dr. Floro's conclusion that multiple drug toxicity was the proximate cause of R.W.'s death also was not shared by the other medical experts, and Dr. Floro conceded that he had no opinion on where the line is crossed between achieving therapeutic levels and toxic or lethal levels in living patients with increased medicinal tolerance. Except for Dr. Floro, all of the other medical experts testified that the Respondent's prescriptions for R.W. continued to be mostly the same types and amount of each drug from R.W.'s first visit to his last; that Respondent's prescriptions did not exceed reasonable amounts of each individual medication; that in some cases the amounts Respondent prescribed were less than the maximum amounts permissible for individual medications; and that the prescriptions, if taken as prescribed, should not have exceeded reasonable amounts for their purpose. Dr. Corral considered Respondent's use of all the drugs together to be common practice. Dr. Hegert considered the combination of drugs selected by Respondent to be appropriate within current chronic pain management therapy and effective, in that because of the combination and amounts Respondent used, Respondent would not have had to prescribe even stronger pain medications which have a greater potential for addiction than those Respondent actually used. Dr. Hegert also found no indication that the drug levels in R.W.'s blood at death, as indicated by the laboratory reports, were any different than the probable levels R.W. had experienced over a considerable period of time. Although Dr. Floro reviewed some cut sections of the deceased's heart, Dr. Floro did not clearly acknowledge evidence of an acute myocardial infarction. Cut sections of R.W.'s heart were prepared with a special stain by Dr. Hegert and microscopically viewed. These sections revealed myocardial injury, "clear evidence" of an acute myocardial infarction. Dr. Hegert concluded that R.W. died of acute myocardial infarction secondary to severe coronary artery disease. There are a few pills from R.W.'s last prescriptions which are unaccounted for, but this is insufficient under the facts of this case to assume that R.W. consumed more pills than the labels prescribed or that excessive use of a single prescription drug or several prescription drugs triggered his myocardial infarction. In light of the testimony of a borderline nature for R.W. of the Hydrocodone level and the probable therapeutic level of the other drugs, there is no clear and convincing evidence that R.W. exceeded the labeled dosage. There is certainly no clear evidence that if R.W. exceeded the labeled dosage, he did so because of Respondent's failure to warn him. Finally, there is no clear and convincing evidence that Respondent's prescription practice rendered R.W. chemically dependent on prescription drugs. AHCA Case No. 95-01594; DOAH Case No. 97-3363; Patient N.W. Mrs. N.W. had been a patient of Respondent since April 17, 1992. Approximately a year before April 6, 1994, N.W. had required hospitalization due to severe gastroenteritis. At that time, she was hospitalized for re-hydration and attendant care. Thereafter, until April 6, 1994, N.W. enjoyed reasonably good health, except that she suffered from systemic lupus and erythema. On Wednesday, April 6, 1994, N.W. presented to Respondent's office with complaints of having eaten bad ham at a picnic, nausea, vomiting, and diarrhea for several days. These were similar symptoms to those at her hospitalization the year before. Long-term nausea, vomiting, and diarrhea can cause severe dehydration. Respondent recommended that N.W. be hospitalized for re-hydration. N.W. and her husband refused, accepting instead a prescription for antibiotics. On Friday, April 8, 1994, N.W. was not improved and either she or her husband contacted Respondent's office. Respondent's office was advised that N.W. had continued to suffer from nausea, vomiting, and diarrhea since her Wednesday office visit. N.W. then accepted Respondent's recommendation, and directions were given for her to be directly admitted to Memorial Medical Center (hospital) in Jacksonville, Florida, without first being seen at Respondent's office. N.W. was admitted to the hospital at approximately 4:30 p.m. Patients suffering from dehydration can develop hypovolemia (low blood volume) and can appear very ill and develop low blood pressure (hypotension); high or low heart rate (tachycardia or bradycardia); and become cold and clammy. These symptoms are also consistent with a myocardial infarction, although high heart rate is more common than bradycardia with a myocardial infarction. Appropriate treatment of hypovolemia is re-hydration through the administration of intravenous (IV) fluids. N.W. ultimately died four days later on April 12, 1994, from congestive heart failure initiated by a myocardial infarction which had most probably occurred sometime around noon on April 8, 1994, prior to her admission to the hospital. All witnesses concur that the only period of time that is material to the charges against Respondent is approximately 4:00 p.m. April 8, 1994 to 8:00 a.m. April 9, 1994. The thrust of the Administrative Complaint is that the information of an abnormal EKG and abnormal cardiac enzymes were repeatedly relayed to Respondent by telephone and that he failed to timely take aggressive action. Sometime subsequent to April 9, 1994, the nursing progress notes covering the period of time from approximately 8:00 p.m. April 8, 1994, until approximately 7:00 a.m. April 9, 1994, were found to be missing. Subsequently, the hospital's Risk Management staff directed that the nursing notes be recreated. The recreated notes were reviewed by the Risk Management staff and the hospital attorney. They were dissatisfied with them as being too subjective. At their instruction, a second set of nursing notes was recreated. However, Risk Management and the hospital attorney ultimately included the first set of recreated notes in N.W.'s hospital chart, believing that the first set of recreated notes would be more accurate because they were closer in time to the events charted. The copy of a 7:32 p.m. April 8, 1994, electrocardiogram (EKG) report currently in the hospital chart, which indicates an acute myocardial infarction, was not the copy of the EKG interpretation that was originally placed in N.W.'s hospital chart during the period of time that N.W. was hospitalized on April 8, 1994. The EKG copy in the hospital chart is a copy that has been interpreted by a cardiologist, Benjamin C. Olive, M.D. The undersigned has had the benefit of considering both sets of recreated notes, the witnesses' testimony, and all other exhibits admitted in evidence. In making the following Findings of Fact, the undersigned has compared, considered credibility, and weighed all elements of the record. After initial evaluation by hospital nursing staff, N.W. was evaluated at approximately 7:30 p.m., by Earl Manion, Respondent's Physician's Assistant. Mr. Manion noted, among other things, that because N.W.'s abdominal pain was very high up into the sternum, cardiac involvement should be investigated. Mr. Manion gave appropriate orders for initial laboratory and radiological evaluation of N.W. A CPK test is part of a standard chemistry panel done for all admittees, but the initial tests ordered by Mr. Manion included the performance of an EKG and blood chemical studies including cardiac enzyme testing (CPK-MB). At Memorial Medical Center, as in many facilities, EKGs are initially interpreted by a computer program, which provides a printed verbal interpretation of the EKG. Hospital nurses are not expected to interpret the line configurations on EKGs. Standard procedure is for them to notify the admitting physician of the computer's printed verbal interpretation. Mr. Manion did not remain on the cardiopulmonary floor to which N.W. was initially assigned (Three South Tower) to read the results of the tests he had ordered. He anticipated that Respondent would shortly be making rounds and would see the test results for himself. He did not relay his cardiac concerns to Respondent or tell Respondent that he had ordered a CPK-MB instead of a CPK test. In fact, Respondent did not make rounds that evening, and there was no requirement that he should do so. Lay persons normally refer to a myocardial infarction as a "heart attack." Persons can suffer from a myocardial infarction and, dependent upon its severity, they may not even be aware it has occurred. A myocardial infarction may be classified as "acute," meaning "recent" or "on-going," or it may be classified as "chronic," meaning "old" or "in the past." If it is an old infarction, no immediate physician response is necessary. The first EKG performed on N.W. printed out the verbal interpretation of "consider inferior infarct, age undetermined." This result is not an acute myocardial infarction alert. This result was reported telephonically to Respondent by Donna Hughes, R.N. Nurse Hughes was the first nurse significantly involved in N.W.'s care, and was the responsible nurse between admission and midnight on April 8, 1994. The CPK-MB test results came in subsequent to Ms. Hughes' first telephone call to Respondent, so she made a second telephone call to Respondent about 10:30 p.m. on April 8, 1994. She subsequently recreated notes to the effect that she related to Respondent that N.W. showed "elevated cardiac enzymes," but in her testimony, Ms. Hughes confirmed that she recalled telling Respondent only that the "CPK" was elevated. Despite reports by N.W.'s husband that his wife's face "was turning colors," neither nurse Hughes nor Physician's Assistant Manion observed such a phenomenon. In fact, to them, N.W. denied any chest pain or chest tightness. Nurse Hughes did not believe that N.W. was having a myocardial infarction during her shift. Chemical tests can be performed on a patient's blood for various enzymes that are released into the bloodstream as a result of stress on muscle systems. Various enzymes and "bands" of enzymes reflect stress or damage to different muscle systems. A CPK is an enzyme test that may indicate damage to muscles in the body generally, or more specifically, damage to skeletal muscles. It may also reflect systems' reactions to injected anti-vomiting medications, which N.W. had received. A CPK-MB (or CK-MB) band is a more specific enzyme test that is indicative of stress or damage to the heart muscle. The CPK-MB (or CK-MB) band is appropriately referred to as a "cardiac enzyme test." The CPK is not appropriately referred to as a "cardiac enzyme test." There is no clear and convincing evidence that Nurse Hughes advised Respondent that the CPK-MB or CK-MB was elevated. It is more likely that she only correctly identified that the test was a "cardiac enzyme test" in her recreated notes. Because Respondent was aware of N.W.'s past history of gastroenteritis and that N.W. had been suffering from vomiting, including retching, and had received intra-muscular injections of anti-nausea medication, and because retching and intra-muscular injections can result in an elevated CPK, it would be reasonable for him to discount the results of a CPK, which he did during the second phone call from Nurse Hughes. He ordered an increase in the potassium IV. Jennifer Stephenson, R.N., was a graduate nurse (G.N.) performing nursing care for N.W. on Three South Tower after midnight on April 8, 1994. She involved the charge nurse and the nurse coordinator due to her G.N. status and due to her concern for N.W.'s condition. She placed a telephone call to Respondent's "service" but did not speak to him. When Respondent returned the telephone call, his call was received by Tess Bunal, R.N. He denied that any clear information about the CPK-MB or about a new EKG was given to him in this phone call. During this phone call, Respondent authorized the transfer of N.W. to the Telemetry Unit (Three Central) for closer monitoring. The Telemetry Unit is a monitored unit with heart pattern displayed at each bedside and at a monitor bank. It provides one staff nurse for every three to four patients. It is only one step down from an intensive care floor. Upon N.W.'s arrival at the Telemetry Unit, Kevin Murphy, R.N. became the nurse involved in her care. Mr. Murphy spoke with Respondent at or about 1:40 a.m. on April 9, 1994, regarding N.W.'s EKG, low blood pressure, and increased heart rate. At that time, Nurse Murphy relied on another nurse's oral report that Respondent had already been informed of the elevated heart enzymes and also had been informed of the results of an abnormal EKG. Nurse Murphy recommended that N.W. be transferred to an intensive care unit, also known as a "cardiac care unit" (CCU). However, Mr. Murphy testified that he did not advise Respondent of the result of the EKG or any specific enzyme results, because he believed Respondent already had that information. The Respondent rejected Nurse Murphy's recommendation to transfer N.W. to CCU. Instead, he gave orders to increase the IV. Nurse Murphy was uncomfortable with Respondent's response to his recommendation. He closely monitored N.W. N.W.'s vital signs did not change markedly, but she continued to complain of nausea and even some chest tightness. Nurse Murphy ordered another EKG, which showed an "acute myocardial infarction." He again spoke with Respondent by telephone at approximately 3:40 a.m. on April 9, 1994, and again requested that N.W. be transferred to the intensive care unit. He did not inform Respondent of an EKG showing "acute myocardial infarction" or that the MB band was elevated. His testimony does not clarify whether he did or did not relay to Respondent any complaint of chest tightness. However, at Nurse Murphy's insistence, Respondent ordered N.W. transferred to CCU. At no time on any of the three units (cardiopulmonary, telemetry, or cardiac care) did any nurse become sufficiently concerned about N.W.'s condition or about Respondent's responses so as to call on the hospital's "fail safe" procedures which included the opportunity to involve an on-call "intensivist." At approximately 7:00 a.m. on April 9, 1994, a new nurse, Nurse Waples, began her shift on CCU. She contacted Respondent by telephone at 7:20 a.m. and advised Respondent clearly that N.W. was complaining of chest tightness, and of the results of the latest EKG. She also clearly stated that N.W. had an elevated CK-MB. Respondent immediately gave appropriate orders for evaluation and treatment of a possible cardiac problem, including EKG, cardiac medication, oxygen, arterial blood gases, pulse oxymeter, and a cardiac consultation, and he proceeded directly to the hospital. The Respondent saw N.W. in the hospital for the first time at 7:55 a.m. on April 9, 1994. At that time, he and a cardiologist correctly diagnosed her as having had an acute myocardial infarction and going into cardiogenic shock. Respondent timely requested the participation of a cardiologist and provided appropriate orders for N.W.'s cardiac condition. He also appropriately monitored her status. Nonetheless, N.W. ultimately went into congestive heart failure. After several unsuccessful treatment attempts, she died on April 12, 1994, at 5:33 p.m. Petitioner's medical physician expert, Dr. Patel, testified that Respondent, in response to the several nurses' telephone calls concerning "elevated cardiac enzymes" and an abnormal EKG, should have either been in immediate personal attendance at N.W.'s bedside, or should have obtained a proper consultation with a cardiologist, and/or should have called on the intensivist provided by the hospital, and that Respondent's failure to take at least one of these courses of action constituted his failure to practice medicine with that level of care, skill, and treatment recognized by reasonably prudent physicians as being acceptable under similar conditions and circumstances. Respondent's experts agreed that if Respondent had received clear notification of an "acute" condition by EKG, of an elevated CPK-MB or CK-MB, or of clear symptomatology such as chest pain, these were "red flags" telling Respondent that he should aggressively address a cardiac problem. However, all experts, even Dr. Patel, concurred that if the EKG had showed only "consider inferior infarct, age undetermined," that, alone, would not be sufficient to trigger an immediate response from Respondent. Based on all he reviewed, which was not all of the evidence in this case, Dr. Patel acknowledged that if the information relayed by Nurse Waples had been given Respondent earlier he could have met the standard of care by merely requesting that the nurse call a cardiologist for a consultation or call the hospital's intensivist to see N.W. Under these circumstances, Respondent would not even have had to come into the hospital, and therefore his failure to respond could not be attributed to "laziness." Because Respondent acted knowledgeably and appropriately when clearly informed of N.W.'s condition by Nurse Waples, Dr. Patel would not attribute Respondent's lack of response to lack of knowledge or ability. Dr. Patel ultimately opined that because the first set of recreated notes showed repeated notifications to Respondent that N.W.'s blood pressure was falling while her heart rate was rising; this, with all the other information, including notification of chest tightness, should have resulted in a more aggressive response from Respondent, but he conceded that these symptoms occasionally are consistent with hypovolemia, and the undersigned notes that in testimony, only Nurse Murphy clearly testified that he notified Respondent of the disparity in blood pressure and heart rate, and did not specifically state that he mentioned chest tightness. No witness clearly suggested that Respondent had an affirmative duty to inquire whether a CPK or CPK-MB had been administered to N.W., or to inquire if a second EKG had been performed after the first one, or to personally order a subsequent EKG based on the several phone calls as related by the testifying nurses. No one testified that repeated phone calls from nursing staff by itself should have alerted Respondent to a myocardial infarction. Respondent's experts concurred that absent clear notification of an elevated CPK-MB, the information that N.W.'s EKG showed an old myocardial infarction did not require any response beyond the responses Respondent made.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Medicine enter a Final Order that Finds Respondent not guilty of violating Section 458.331(1)(t) in DOAH Case No. 97-3363 with regard to Patient N.W. Finds Respondent not guilty of violating Sections 458.331(1)(q) and (t), in DOAH Case No. 97-3442 with regard to Patient R.W. Finds Respondent guilty of violating Section 458.331(1)(m) Florida Statutes, in DOAH Case No. 97-3442 with regard to Patient R.W., and imposes a penalty of two months suspension of license followed by probation of Respondent's license for six months upon such terms and conditions as the Board may impose to correct his record-keeping, and imposes a $1,000.00 fine. See Rule 21M-20.001(2)(m), Florida Administrative Code. DONE AND ENTERED this 18th day of August, 1998, in Tallahassee, Leon County, Florida. ELLA JANE P. DAVIS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 18th day of August, 1998. COPIES FURNISHED: Bruce Lamb, Esquire Shear, Newman, Hahn & Rosenkranz, P.A. Post Office Box 2378 Tampa, Florida 33601 Albert Peacock, Senior Attorney Agency for Health Care Administration 2727 Mahan Drive Post Office Box 14229 Tallahassee, Florida 32317 Dr. Marm Harris, Executive Director Department of Health Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Angela T. Hall, Agency Clerk Department of Health 1317 Winewood Boulevard Building 6 Tallahassee, Florida 32399-0700
The Issue Whether the permit held by the Respondents to operate a pharmacy in the State of Florida should be revoked.
Findings Of Fact A Complaint and Notice to Show Cause was filed against the Respondents, Ponce de Leon, Inc., doing business as Capel Drugstore, and Milagros Ferreras, Evina Valera and Julio C. Pascual, on December 27, 1978, alleging that the Respondents failed to maintain on a current basis a complete and accurate record of controlled substances controlled by Chapter 893, Florida Statutes, and that Respondents while holding a permit to operate a pharmacy in the State of Florida permitted the unlawful practice of pharmacy at Ponce de Leon, Inc., doing business as Capel Drugstore, located at 6661 SW 8th Street, Miami, Florida, by permitting a person not licensed or registered as a pharmacist or pharmacy intern in this state, to wit Milagros Ferreras, to fill and dispense a controlled substance with prescriptions and without prescriptions to various people on various dates. A hearing was requested by the Respondents on January 5, 1979. Notice of Hearing was sent to the parties on February 5, 1979. The first witness called on behalf of the Petitioner was V. K. Bell, Agent for the Florida Board of Pharmacy and a licensed pharmacist. Agent Bell testified that while at a local wholesaler in the Miami area he noticed that Ponce de Leon, Inc., doing business as Capel Drugstore, had been buying a large volume of Quaalude tablets, which is a Schedule II controlled substance that has been the subject of high abuse in the Dade County area. Thereupon, he proceeded to Capel Drugstore in order to review their records. He said that he found the prescription records did not account for proper disposition through lawful dispensing of a large volume of the Quaalude tablets that were purchased and documented by the invoices. He testified that he talked with the pharmacist, Francisco DeQueuedo, and Respondent, Milagros Ferreras, one of the owners of Ponce de Leon, Inc., doing business as Capel Drugstore, and the President of the corporation. Mr. Bell advised Ms. Ferreras and Mr. DeQueuedo of their right to remain silent and not answer questions, that anything they said could be used against them, and that they had the right to have an attorney present if they desired. He then questioned the Respondent, Ms. Ferreras, and Mr. DeQueuedo. Ms. Ferreras stated that she had bought a bad business and found that she was having financial difficulties with the business, and she started to sell Quaalude tablets for 50 cents each to some 15 or 20 different people without prescriptions. Mr. Bell testified that Ms. Ferreras then stated that she had made sales of the controlled substance without prescriptions. Agent Bell testified that the pharmacist, Mr. DeQueuedo, admitted to him that he knew that Respondent Ferreras was making these sales, and that she would from time to time bring him prescriptions which he would sign, indicating on the prescriptions that he did in fact fill them, although he had not, and then put them on file at the pharmacy in an attempt to cover up some of the shortages due to the unlawful sales of the Quaalude tablets. After this conversation Mr. Bell testified that he proceeded to do a drug accountability audit. Mr. Bell said that even with giving the pharmacy credit for those prescriptions which were signed by the pharmacist, he could not account for 27,440 Quaalude tablets. The drug accountability report was identified by Mr. Bell and was introduced into evidence as Petitioner's Exhibit number 1. Agent Bell identified a series of documents which constituted various invoices and prescriptions utilized in the drug accountability audit as well as a perpetual inventory, which the pharmacist had run. These documents were marked as Petitioner's Composite Exhibit number 2 and were introduced into evidence. Thereafter, Mr. Bell identified a document which he noted was a copy of a receipt which he gave to the pharmacist noting the various invoices contained in Composite Exhibit number 2, which were removed from the pharmacy. This receipt was marked as Petitioner's Exhibit number 3 and was introduced into evidence. Mr. Bell verified a document which was the receipt that he gave to the pharmacist, Mr. DeQueuedo, when he removed the original prescriptions from the pharmacy file, which prescriptions were also part of the Composite Exhibit number 2. This receipt was marked as Petitioner's Exhibit number 4 and was introduced into evidence. Mr. Bell then identified another document, which was marked for identification as Petitioner's Exhibit number 5, and Agent Bell testified that this was a statement made to him in his conversations with the Respondent, Ms. Ferreras, and the pharmacist, Mr. DeQueuedo, which he reduced to writing and which both the pharmacist and Respondent Ferreras signed. Exhibit number 5 substantiates the testimony which was given by Mr. Bell in respect to the unlawful dispensing of controlled substances by Ms. Ferreras, falsification of the prescription records by Mr. DeQueuedo, and the shortages found in the drug accountability audit. Robert S. Pacitti, a police officer with the Dade County Public Safety Department, was called as a witness for Petitioner. Officer Pacitti stated that he had received a telephone call from Agent Bell with reference to Ms. Ferreras and Mr. DeQueuedo. Officer Pacitti testified that he went to the Capel Drugstore and advised both the Respondent Ferreras and Mr. DeQueuedo, the pharmacist, of their Miranda rights. Officer Pacitti obtained a verbal statement from Mr. DeQueuedo that he was aware of the fact that Ms. Ferreras was dispensing Quaalude tablets. Officer Pacitti then took Respondent Ferreras down to the Dade County Public Safety Department, where she made a statement taken by a stenographer in Officer Pacitti's presence confirming the testimony of Agent Bell and Officer Pacitti. Respondent Ferreras stated that the individuals to whom she had sold Quaalude tablets promised to bring her prescriptions for them at a later date but did not do so. Officer Pacitti identified a document marked as Petitioner's Exhibit number 6 as a copy of the statement of Respondent Milagros Ferreras, and thereafter this statement was introduced into evidence as Petitioner's Exhibit number 6. Officer Pacitti testified that even though the large quantity of Quaalude tablets was being sold for 50 cents each, the street value of these tablets was between $3.00 and $5.00 per tablet. The secretary of Jack R. Blumenfeld, the attorney of record for Respondent Milagros Ferreras, presented photocopies of letters from two physicians indicating that Ms. Ferreras had been in the hospital and then had been advised to restrict her physical activity and avoid emotional strain. These letters were marked and filed by the Hearing Officer. After listening to the testimony of Agent Bell and Officer Pacitti, and after examining the exhibits introduced into evidence, it is the finding of this Hearing Officer that the Respondent, Milagros Ferreras, did permit the improper keeping of records at Ponce de Leon, Inc., doing business as Capel Drugstore, and that complete and accurate records of controlled substances were not maintained on a current basis. It is the further finding of this Hearing Officer that the Respondent, Milagros Ferreras, allowed the pharmacist, Francisco DeQueuedo, to file false information in the files of Ponce de Leon, Inc., doing business as Capel Drugstore, by placing prescriptions in the files which were not actually dispensed by the pharmacist to the individuals named thereon. The Hearing Officer finds that the Respondent, Milagros Ferreras, President of the corporation doing business as Capel Drugstore, improperly dispensed and sold Quaalude tablets to individuals with prescriptions and to individuals without prescriptions.
Recommendation Revoke the permit to operate a pharmacy in the State of Florida issued to Ponce de Leon, Inc., doing business as Capel Drugstore, and Milagros Ferreras, Evina Valera and Julio C. Pascual. DONE and ORDERED this 15th day of March, 1979, in Tallahassee, Leon County, Florida. DELPHENE C. STRICKLAND Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Jack R. Blumenfeld, Esquire 619 NW 12th Avenue Miami, Florida 33136 Michael Schwartz, Esquire Suite 201, Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 H. F. Bevis Executive Secretary Florida Board of Pharmacy Post Office Box 3355 Tallahassee, Florida 32302
Findings Of Fact Respondent, Gregory Burgess Stone, is a licensed practical nurse holding license number 0463451. Respondent was so licensed at all times relevant to this proceeding. Respondent was employed at Orlando Lutheran Towers Health Care Center, 300 East Church Street, Orlando, Florida, as a practical nurse at all times material hereto. During April, 1982, Respondent acted as the full-time medicine nurse on the 7:00 a.m. through 3:00 p.m. nursing shift at Orlando Lutheran Towers. Orlando Lutheran Towers utilizes the Unidose system of medication administration. The individual who administers the medication is required only to remove the appropriate dosage from the Unidose card which may contain from thirty to sixty doses of medication and thereafter record the administration of the medication on a medication administration record by inserting his initials under the appropriate date on the medication administration record format. Each patient at Orlando Lutheran Towers is assigned a Unidose card for each medication he may require. The patient's name and other pertinent information appear on a label placed on the front of the Unidose card. Respondent was intermittently relieved from duty in April by Gloria Underhill, another nurse-employee of Orlando Lutheran Towers. Underhill worked in place of Respondent on April 8, and the Respondent thereafter worked the intervening period from April 9 through April 12. Underhill returned to work in place of Respondent again on April 13, and in the course of administering medications, she observed that certain prescribed medications had not been administered between April 9 and April 13. Underhill ascertained this information because of the procedure she had previously followed. It was Underhill's general practice to place her initials not only on the medication administration record but also on the Unidose card next to the particular unit of medication she intended to administer. By comparing her initials with the physical presence of the succeeding units of medication in the Unidose card, she determined that the Respondent had apparently failed to administer medication to the following patients: PATIENT MEDICATION UNITS NOT RECEIVED 1. Lowe DDS 100 milligrams 4 2. Doze Corgard 40 milligrams 4 3. Miller TAM/LL 3 The medication administration record, however, indicated by the placement of the Respondent's initials that the foregoing medications had been received. Respondent speculated that he may have administered the medication by utilizing doses not taken by other patients. This possibility was not supported by the evidence and is rejected. Underhill's findings were given to the Director of Nursing and the Administrator of Orlando Lutheran Towers, who thereafter confronted Respondent with the Unidose card discrepancies. Respondent did not offer any explanation for the discrepancies and was therefore discharged from employment at Orlando Lutheran Towers.
Recommendation Based on the foregoing, it is RECOMMENDED: That Petitioner enter a final order finding Respondent guilty of the violations of law charged in the Administrative Complaint and placing his license in a probationary status for two years. DONE and ORDERED this 18th day of March, 1983, in Tallahassee, Florida. R. T. CARPENTER, 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 18th day of March, 1983. COPIES FURNISHED: W. Douglas Moody, Esquire 119 North Monroe Street Tallahassee, Florida 32301 James M. Nicholas, Esquire 170 East Washington Street Orlando, Florida 32801 Helen P. Keefe, Executive Director Board of Nursing Department of Professional Regulation Room 504, 111 East Coastline Drive Jacksonville, Florida 32202 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
