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
The Issue The issue is whether the pharmacy permit issued to the Respondent, North Florida Drug Corporation, d/b/a Scottie Discount Drugs, should be revoked or otherwise penalized based on the acts alleged in the Administrative Complaint.
Findings Of Fact North Florida Drug Corporation, d/b/a Scottie Discount Drugs, currently holds permit No. PH 0004096 as a Community Pharmacy. Respondent is located at 1448 Bakers Square, Macclenny, Florida. On December 24, 1987, Gustave Goldstein, who had been the designated prescription department manager for Respondent, resigned as a pharmacist at the Respondent's location. He notified Frankie Rosier, the owner and operator of the Respondent, that he was leaving and he notified the DPR that he would no longer be the designated prescription department manager. Carl Messina is the relief pharmacist for the Respondent. From the time of Goldstein's resignation, Messina has told Ms. Rosier many times that it is illegal to operate without a prescription department manager. DPR inspected the Respondent's pharmacy in December, 1987, and determined that there was no prescription department manager after Goldstein quit. DPR conducted an inspection of the Respondent's premises on February 16, 1988, and discovered that there still was no prescription department manager employed there. Frankie Rosier was made aware of this deficiency. On February 16, 1988, the official records of DPR showed that no new designation of a prescription department manager had been filed by Respondent and Goldstein was still listed as the prescription department manager by Respondent. On May 22, 1988, DPR again inspected the premises and determined that there was still no prescription department manager. It is important that each permittee have a designated prescription department manager to assure that all required records are kept and that the pharmacy complies with all legal requirements. This is especially important regarding control and accountability for controlled substances. Without a prescription department manager, a non-pharmacist owner, like Ms. Rosier, would and does have access to these controlled substances without any accountability. By Final Order entered and filed with the agency clerk on December 17, 1987, this same permittee was fined and placed on probation for operating a community pharmacy with an expired permit and for obtaining a permit by misrepresentation or fraud or through an error of the department or the board.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Professional Regulation, Board of Pharmacy, enter a Final Order finding North Florida Drug Corporation, d/b/a Soottie Discount Drugs, guilty of the violations alleged and revoking the community pharmacy permit No. PH 0004096. DONE and ENTERED this 14th day of October, 1988, in Tallahassee, Florida. DIANE K. KIESLING Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14th day of October, 1988. COPIES FURNISHED: Michael A. Mone' Staff Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 North Florida Drug Corporation Scottie Discount Drugs 1448 Bakers Square Macclenny, Florida 32063 Bruce Lamb General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Rod Presnell, Executive Director Board of Pharmacy Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
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
The Issue Whether or not the Respondent's license to practice pharmacy should be suspended or revoked pursuant to Section 465.101(1)(e) and 893.13(3)(a) 1 , Florida Statutes. The Hearing Officer explained to the Respondent the nature of the hearing and his rights under the Administrative Procedure Act, including the right to be represented by counsel at his own expense, if he so desires. It was also explained to the Respondent that he could testify in his own behalf, but that he was not required to do so and that if he did so testify, he could be cross- examined by counsel for Petitioner. Respondent acknowledged understanding of these rights and elected not to testify in his own behalf during the course of the hearing; however, he did participate in the cross-examination of Petitioner's witnesses and made a closing statement in which he denied the allegations against him.
Findings Of Fact During the period in question, i.e., April, 1975, Mr. Stanley Margolis was the manager of Gray Drug Store, No. 365, located at 12852 Biscayne Boulevard, North Miami, Florida. He and the Respondent are the only licensed pharmacists employed at that store (testimony of Mr. Margolis). "Eskatrol" is a trade name for a drug which is bottled and sold in capsules called "spansules". It contains dextro- amphetaminesulfate and acts as a stimulant on the central nervous system. It is used primarily as an appetite suppressant, although it also is sometimes prescribed in an emergency situation for narcolepsy to keep a person awake. It is a Schedule II drug under the Florida Comprehensive Drug Abuse and Prevention Act, Chapter 893, F.S. because it is an amphetamine (Testimony of Mr. Bell, Dr. Danoff). The procedure employed by Gray Drug Store to order Schedule 11 drugs was for Mr. Margolis to write a narcotic order form which he sent to a wholesaler who would then fill the order and send back an invoice with the narcotics in a box that was signed for by one of the pharmacists. At that time, the drugs would be counted, checked off and written down. Either Margolis or Respondent was on duty at the drug store at all times when it was open for business and Respondent could sign for such deliveries if Margolis was not then present. On approximately April 10 or 11, the store had run out of narcotics order forms and had exhausted its supply of several drugs, including ones with the trade name of Eskatrol. However, on Saturday, April 12, a prior order for ten bottles of Eskatrol, each bottle containing 50 capsules or "spansules" as they were termed, were received at the store. Respondent was on duty at this time and signed for the shipment. It was his responsibility to check the numbers of bottles received, enter the amount in a narcotics journal and place the drugs in a locked cabinet. On Monday, April 14, Margolis came on duty, reviewed the receipt of Eskatrol and determined that the shipment was correct based upon his examination of the invoice. He did not check the drug cabinet at this time. About 6:00 or 7:00 p.m. he received a prescription for 50 sparsules of Eskatrol. At this time, he noticed that there were only eight bottles in the cabinet when there should have been ten. He thereupon checked his prescription files for narcotic and other drugs and found no prescription to cover the two missing bottles of Eskatrol ewhich would have contained a total of 100 spansules. The store maintained a daily prescription log which indicated the prescriptions filled and a "waiting" file which was used to hold prescriptions for emergency drugs which had been issued pursuant to a telephonic request of a physician while waiting for the written prescription from the physician to arrive at the store. Mr. Margolis, on the morning of April 16, asked Respondent about the discrepancy. The Respondent told him that the wholesaler had been" short two bottles." Margolis was disturbed about this alleged shortage and therefore called the district manager of Gray Drugs, a Mr. Krake. On the morning of April 17, Margolis found a telephoned prescription form for 50, spansules of Estatrol in the "waiting" file (Petitioner's Exhibit 1). The Respondent told him that it had been called in and that he was waiting for the prescription. He said that he had written the prescription. Margolis identified the handwriting as being that of the Respondent. The prescription was in the name of Ron Richards and showed an address of "2405 Northeast 135". It did not bear a street, avenue, or city designation. There was no date entered in the "Date" space on the form, but the figures "4/14" appeared on the "RX" portion of the form. This portion also bore the handwritten number 221030, and showed the figures "825". The doctor's name was Danoff and shown with address of 4100 South Hospital at Plantation. The number 5870448 also appeared on the prescription form and the words "will mail". Mr. Margolis then reviewed what had been entered on Sunday in the prescription log book and discovered that prescription number 221030 showed a patient named Kasen and a price of $1.95 for the prescription (Petitioner's Exhibit 2) . The practice of the pharmacy had been to use a numbering machine which would stamp the prescription and the patient's receipt with the prescription number. Although 99 percent of the prescriptions are marked with the numbered stamp, occasionally there can be some mistake if the machine jumps, and the same number can only be stamped two times by the machine. On April 14, while Mr. Margolis was checking the non-narcotic prescription files, he had seen a prescription numbered 221030 for 15 Actifed tablets, prescribed by a Dr. Wrench for a patient named Kasen. The retail price of 15 Actifed tablets is $1.95. His log book also reflected that the next number in sequence, prescription no. 221031, was also prescribed by Dr. Wrench for patient Kasen for Keflex (Petitioner's Exhibit 3). Both of these prescriptions were entered on the log for April 13th. Margolis does not know what happened to the other prescription bearing the number 221030; he saw it last on the night of April 15 (testimony of Mr. Margolis; Petitioner's Exhibits 1-3). Dr. Sherwood Danoff, a licensed physician who practices at Plantation, Florida, specializes in dermatology. He is not familiar with the name of Ron Richards and did not call the Gray Drug Store of North Miami, Florida, on April 13, 1975, to order Eskatrol for that individual. He had never written a prescription for Eskatrol, which is a combination of an amphetamine and a barbituate used in diet control as an appetite suppressant. He did not receive a phone call on April 13 from the Gray Drug Store and has never spoken on the phone to anyone representing himself to be the Respondent Mark Gorsky. The normal dosage of Eskatrol is one or two capsules a day and, although he has prescribed Schedule II drugs on an emergency basis over the phone, he would never issue a prescription for a dosage that would cover more than a 10-day period. An emergency prescription by telephone is usually given only for the period until the patient can get in to see the doctor. This is known as an oral prescription and the doctor must follow this up with a written prescription within 72 hours. Although Petitioner's Exhibit 1 reflects Dr. Danoff's phone number, he did not phone in the prescription (testimony of Dr. Danoff). On April 17, Mr. William W. Smith, the regional manager of Professional Services for Gray Drug Stores, Mr. Anthony Difulio, the Director of Loss Prevention for the drug Store chain for Florida, and Mr. Vernon K. Bell, an agent for the Florida Board of Pharmacy, met at the Gray Drug Store in North Miami to look into the discrepancy reported by Mr. Margolis. Mr. Smith made an inspection of the books and records of the store and discovered that certain narcotic drugs were missing, including two bottles of Eskatrol. He checked with Dr. Danoff's nurse and Gulf Company, the wholesaler of Eskatrol. He tried to find the address of Ron Richards, as shown on the prescription in an incomplete form, but any projection of the address by avenues or streets would place it in Biscayne Bay or the ocean. Mr. Smith, together with Mr. Difulio, Mr. Bell, and Mr. Krake, went into a back room of the drug store to discuss the situation and later asked the Respondent to join them. Neither Mr. Difulio nor Mr. Bell arc law enforcement officers and do not have the power to take a person into custody other than that effected under an ordinary citizen's powers. During this period, not all of the above-mentioned individuals remained in the room during the entire period of approximately an hour or an hour and a half. Mr. Gorsky left the room on two occasions. Prior to questioning the Respondent, Mr. Bell advised him that he did not have to answer any questions, that he had a right to remain silent and a right to counsel. He did not threaten him or offer him any inducements to answer questions. After this warning, Respondent decided not to take the polygraph or make a written statement, but he did make oral statements. At no time was Respondent told he was under arrest. Mr. Bell asked Respondent if he could explain or know anything about the shortage of Eskatrol. The Respondent stated that he had received a call from Dr. Danoff on Sunday, April 13, concerning the prescription and that he called the doctor back to make sure that it was authentic; that he had placed the `number at the right bottom of the prescription and in his mind it was legitimate. When asked about the existence of Ron Richards, Respondent told Bell that Richards had been in the store several times. Respondent admitted to Bell that he had written the prescription (Petitioner's Exhibit l) and that it was his handwriting. There is a certain conflict in what Respondent stated at this meeting in view of the fact that Mr. Difulio testified that Respondent had said a customer had come into the store on April 13 and said that a doctor wanted him to have Eskatrol; that he had called the doctor and verified the prescription. Difulio did not recall if Respondent had stated that he had first had a call from the doctor, although he testified that Respondent said that he had prepared the prescription and filled it for Richards. When shown by Difulio that the cash register tapes for April 13 did not reflect an entry of $8.25, and Respondent was asked for an explanation, he stated that he had probably "got taken" by believing the telephone number he called was that of the doctor. In addition, Respondent told Difulio that after filling the prescription, he became scared and put a number on it from another patient and, when asked by Difulio what had happened to it, Respondent stated that he had torn it up and destroyed it. Difulio did not recall Respondent telling Mr. Bell about Dr. Danoff calling Respondent concerning the prescription. However, Respondent made several different statements during the course of his interrogation while various of the parties to the meeting went in and out of the room (testimony of Mr. Smith, Mr. Difulio, Mr. Bell).
The Issue Whether Respondent's permit to operate a pharmacy should be suspended or revoked for alleged violations of Sections 465.18(1)(b), 465.18(2)(b), 465.22(1)(c), Florida Statutes, and Rule 21S-1.14, Florida Administrative Code. At the commencement of the hearing, counsel for Respondent moved to continue the proceedings in order that Detective Robert Delgado could be deposed. There being no showing that a timely notice of taking deposition had been issued or a subpoena requested therefor, the Motion was denied.
Findings Of Fact While on a routine inspection of a pharmacy, Vernon K. Bell, investigator for the Petitioner, obtained a prescription issued by Dr. Rafael Cardella, Miami, Florida for 30 tablets of cardilate, 10 miligrams, that had not been picked up at the pharmacy by the person designated in the prescription. Bell secured this prescription for use in investigation of other pharmacies. Cardilate is a vasodilator that is used by cardiac patients with angina pectoris as a maintenance medication to prevent one from having angina pectoris attacks. It is a product made by Burroughs Wellcome Pharmaceutical House and consists of scored white tablets. The tablets act similarly to nitroglycerin medication and are dispensed only upon prescription (Testimony of Bell, Petitioner's Exhibit 1.) Acting upon a prior complaint against Respondent's pharmacy, Bell conducted an investigation into its practices with regard to dispensing prescription medicine. At 8:50 P.M., January 14, 1976, he provided the cardilate prescription to officer Robert Delgado, intelligence investigator, Dade County Public Safety Department, who entered Respondent's pharmacy to see if the prescription would be filled during a period when it was assumed that the registered pharmacist was not on duty. He handed the prescription to Concepcion Prada and asked that it be filled. She went to the prescription area of the pharmacy through an unlocked door and in five or ten minutes came back with a bottle of pills labeled "cardilate 10". Delgado had been unable to observe who had filled the prescription. Mrs. Prada told him that she only had ten tablets, but that he could come the next day for the remainder of the prescription of thirty tablets. He paid her $1.50 for the medicine, left the pharmacy, and turned the bottle over to Bell who was outside (Testimony of Delgado, Petitioner's Exhibit 2.) Bell thereupon entered the Pharmacy, identified himself and asked Mrs. Prada if there was a pharmacist on duty. She responded in the negative. Bell then proceeded through an open door into the prescription department and picked up the prescription that he had given to Delgado. He then asked Mrs. Prada who had filled the prescription and she informed him that she had done so. He then told her that he would be issuing a violation complaint in the matter. Mrs. Prada had been a registered pharmacist in Cuba, but had informed Bell on a prior occasion that she was not a registered pharmacist in Florida. At the time of the incident described above, she told him that she was going to attend classes at Loyola School. This school prepares individuals who desire to obtain qualifications for taking examinations for registration before the Board of Pharmacy. Circumstances surrounding the statements made by Mrs. Prada to Bell establish that they were made voluntarily (Testimony of Bell.) It is possible that cardilate could save a life under certain circumstances. At the time of the dispensing of the medicine in question, three or four pharmacies within 10 blocks of Respondent's pharmacy were open (Testimony of Bell.)
Recommendation That a civil penalty in the sum of $500.00 be imposed against Respondent under the authority of Section 465.101(3), Florida Statutes, for violation of Section 465.18(1)(b), Florida Statutes, and Rule 21S-1.14, Florida Administrative Code. DONE and ENTERED this 19th day of April, 1976, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 Filed with the Clerk of the Division of Administrative Hearings this 19th day of April, 1976. COPIES FURNISHED: Michael Schwartz, Esquire 201 Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 Stanley P. Kaplan, Esquire 404 Biscayne Building Miami, Florida Guillermo F. Mascaro, Esquire 301 Almeria, Suite 3 Coral Gables, Florida 33134 Emilio De La Cal, Esquire 301 Almeria Avenue Coral Gables, Florida
The Issue The issues are whether Petitioner is liable to Respondent for Medicaid reimbursement overpayments, and if so, in what amount.
Findings Of Fact Respondent is the agency charged with administration of the Medicaid program in Florida pursuant to Section 409.907, Florida Statutes. Petitioner provides services to Medicaid beneficiaries under provider No. 1000098-00 pursuant to a contract with Respondent. Under the provider agreement dated March 31, 1997, Petitioner agreed to comply with all local, state and federal laws, rules, regulations, licensure laws, Medicaid bulletins, manuals, handbooks, and statements of policy. The contract also sets forth Petitioner's responsibilities to keep and maintain in a systematic and orderly manner all medical and Medicaid-related records, and to make them available for state and federal audits for five years. Heritage Information Systems, Inc. (Heritage) is and has been a pharmacy audit company since 1980. In 1999, Respondent contracted with Heritage to perform audits of pharmacies enrolled in the Florida Medicaid program. Respondent and Heritage subsequently created a list of violations to be investigated during an audit. The list is based upon provisions in the Florida Statutes and federal Medicaid policies and regulations. The purpose of the list is to guide Heritage in performing its duty during an audit. Heritage conducts its audits based on a standard methodology and protocol. During the course of an audit, Heritage examines a provider's records to determine whether a pharmacy is compliant with all rules and regulations that apply to the pharmacy. Heritage uses an established set of neutral criteria to select pharmacies for participation in an audit. Using these criteria, Heritage selected Petitioner as a candidate for audit. By letter dated January 17, 2000, Heritage advised Petitioner that it would be audited on January 26, 2000. The letter stated as follows in relevant part: The auditor(s) will require access to original hard-copy prescription records, third party signature logs, and, in some cases, pharmacy computer screens relating to a sample of prescription claims billed by your pharmacy between 12/25/1998 and 12/24/1999. Please note that the sample claim may actually be a refill of a prescription originally dispensed prior to the audit period. Because of this, we recommend that you also have the prior twelve months of prescription records available the day of the audit. For your reference, the audit terms are defined in your participating provider agreement and the prescribed drug services handbook. If you have any additional questions prior to the audit, please call Heritage Information Systems, Inc. . . . Between December 25, 1998, and December 24, 1999, Petitioner submitted claims and received payments from the Medicaid program for 7,065 claims. Using an industry standard software application, Heritage selected a random sample of 101 of Petitioner's claims to be analyzed during the audit. In performing the audit, Heritage utilized a methodology similar to that used by auditing agencies who examined Medicaid providers in previous years. During the audit, Heritage identified four areas of noncompliance for Petitioner. First, Heritage requested Petitioner's staff to produce hard-copy prescription records for the 101 sampled claims. Hard-copy prescriptions include those ordered and signed by a physician on a handwritten form and the records created by the pharmacists immediately after receiving verbal authorization from a physician by telephone. In this case, Petitioner could not produce hard-copy prescriptions for five claims. The second area of noncompliance involved unauthorized refills. In seven instances, Petitioner refilled prescriptions more times than the number authorized on the documented prescription. There were no notations on the hard-copy prescriptions or in the pharmacy computer to indicate that the doctors or someone from their office called to increase the number of authorized refills. The third area of noncompliance involved one instance in which Petitioner claimed payment for a "days supply value" that was inconsistent with the quantity and directions on the prescription. The prescription at issue was for sixty tablets with directions for the patient to take the drug once a day, constituting a sixty-day supply of medicine. Petitioner filled this prescription as a thirty-day supply and claimed Medicaid payment accordingly. Respondent did not include this violation in the calculation of overpayment. The fourth area of noncompliance involved a prescription that was refilled 30 days earlier than appropriate with respect to the quantity and directions for use that appeared on the prescription. This was the same prescription referenced above in paragraph twelve. After completing the audit, Heritage completed a final audit report. Said report documents the following: (a) 7,310 claims submitted by Petitioner; (b) $350,639.95 paid by Respondent for all claims; (c) 101 claims in total random sample; (d) $3,839.33 paid by Respondent for claims in total random sample; (e) 13 discrepant claims in random sample; $778.09 paid by Respondent for discrepant claims; 13 documented sanctions in random sample; (h) $724.91 paid by Respondent for documented sanctions in random sample; (i) $52,466.25 as the total calculated overpayment; and (j) $13,798.70 as the amount of the overpayment based on a 95 percent one-sided lower confidence limit. The final audit report also contained a listing of the violations discovered during the audit. The final audit report contained the following comments/notes in relevant part: Five prescriptions could not be found by auditors and could not be found by pharmacist Geiger and technician Daniels either. Many unauthorized refills were noticed. Pharmacy staff stated some information may be on the old computer system that was not functioning because of Y2K problems. Any authorization or documentation that was found on the computer system was accepted. Under cover of a letter dated March 2, 2000, Petitioner furnished Respondent with statements relative to the discrepant claims/documented sanctions signed by several physicians. All of the statements included the following: (a) statements that the doctors had prescribed the medication(s) for their patients; (b) the patient name; (c) the prescription number; (d) a print-out of a computer screen; and (e) opinions that Petitioner would not fill or refill prescriptions without authority and approval. None of these physicians testified at the hearing. By letter dated August 16, 2000, Respondent notified Petitioner of the determination of a Medicaid overpayment in the amount of $13,798.70. The greater weight of the evidence indicates that Petitioner received an overpayment in that amount or more.
Recommendation Based upon the findings of fact and conclusions of law, it is RECOMMENDED: That Respondent enter a final order finding that Petitioner must timely pay Respondent $13,798.70 for Medicaid reimbursement overpayments from December 25, 1998, through December 24, 1999. DONE AND ENTERED this 30th day of January, 2001, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD 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 30th day of January, 2001. COPIES FURNISHED: Melvin H. Fletcher, R.Ph. Corporate Representative Mayhugh Drugs, Inc. 200 South Orange Avenue Green Cove Springs, Florida 32043 L. William Porter, II, Esquire Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3116 Tallahassee, Florida 32308
