Findings Of Fact Respondent is, and has been at all times material to this proceeding, a community pharmacy in the State of Florida, having been issued permit number 0008482. Respondent's last known address is A & C Pharmacy #2, 1053 Washington Avenue, Miami Beach, Florida 33139. On May 29, 1984, and May 30, 1984, an audit was conducted at respondent's pharmacy by investigators for the Department of Regulation. The audit covered the period from March 15 1984, the date the permit was first issued and the business first opened, to May 29, 1984. The audit revealed that the pharmacy was unable to produce records to account for shortages in the following controlled substances, 1/ as defined in Chapter 893, Florida Statutes, and the evidence revealed the shortages to be in the following amounts: DRUG SHORTAGE Librium 5 mg. 62 capsules Darvon Compound 65 120 capsules Tenuate 75 mg. 130 tablets Valium 5 mg. 55 tablets Valium 10 mg. 8 tablets Librium's generic name is chlordiazepoxide, Darvon Compound 65 contains propoxyphene, Tenuate's generic name is diethylpropion, and Valium's generic name is diazepam. Section 893.07(1)(b), Florida Statutes, requires that every person engaged in dispensing controlled substances maintain "on a current basis a complete and accurate record of each substance manufactured, received, sold, delivered, or otherwise disposed of by him . . ." The audit revealed that the respondent did not have records that showed the disposition of the controlled substances listed above. The records of respondent were in disarray and, to some extent, were mixed with the records of a related pharmacy, A & C Pharmacy #1, located on Flagler Street. Controlled substances were often ordered at the same time for both pharmacies and, on occasion, drugs ordered by one store were delivered to the other. Indeed, due to the poor record keeping, there was some confusion concerning the amount of Tenuate received by the respondent and, accordingly, the amount of the shortage. It is undisputed that respondent received 200 tablets of diethylpropion or Tenuate, on April 9, 1984. On May 10, 1984, an additional 100 tablets of diethylpropion were ordered. The invoice revealed that these tablets were ordered by the A & C Pharmacy on Flagler Street. However, Mrs. Rodriguez provided the invoice to the auditors as part of respondent's records. She also told the auditors that 100 tablets of Tenuate had been transferred from the Flagler Street pharmacy to the respondent due to orders being mixed-up and drugs ordered by one store being delivered to the other. The auditors therefore determined that respondent and received 400 Tenuate tablets: 200 on April 9th, 100 on May 10th, and, an additional 100 transferred from the Flagler pharmacy. There were 170 tablets in respondent's inventory, and no records of any sale. Thus, the auditors determined that there was a shortage of 230 tablets. However, from the evidence presented at the hearing, it appears that the 100 tablets that Mrs. Rodriguez mentioned were the same 100 tablets shown on the invoice dated May 10, 1984. Ms. Jorge's testimony linked the tablets that were transferred to an invoice that had the Flagler pharmacy's address (T-73), and Mr. Bludworth's testimony established that the only records showing purchases were the invoices of April 9 and May 10, 1984. (T-34) Thus, the shortage of Tenuate was 130 tablets rather than 230 tablets. At the time of the audit some of respondent's records, the prescriptions filled, had been sent to Luis Cruz, a Medicaid preparer. However, there was no evidence that any of the prescriptions that had been sent to Luis Cruz were for the controlled substances audited. The evidence establishes that respondent has failed to maintain, on a current basis, a complete and accurate record of each substance manufactured received sold, delivered or otherwise disposed of by respondent. On May 10, 1984, an inspection of Respondent's pharmacy was conducted by an investigator for the Department of Professional Regulation. At the time of the inspection, Ada Rodriguez, the owner of A & C Pharmacy was in the prescription department. Ada Rodriguez is not a licensed pharmacist in the State of Florida. The pharmacist on duty was not present when Ada Rodriguez was in the prescription department. There was no pharmacist on the premises at the time the inspection began, and the prescription department was not locked. No activity was observed by the investigator which would be consistent with an unlicensed pharmacist dispensing drugs. When the inspection was conducted, the business hours for the store where respondent's pharmacy is located were 8:30 a.m. to 5:00 p.m., Monday through Friday, and 9:30 a.m. to 3:30 p.m. on Saturday. When the inspection was conducted, the prescription department hours were from 9:00 a.m. to 3:00 p.m., Monday through Friday, thus the prescription department was open a total of thirty (30) hours a week. Rule 215-1.14, Florida Administrative Code, provides in part as follows: [A]t all times when the prescription depart- ment is closed, either because of the absence of a . . . pharmacist or for any other reason, said prescription department shall be . . . locked or padlocked so as to prevent the entry into said department by persons not licensed to practice pharmacy in the State of Florida, and at such times no person other than a person licensed to practice pharmacy in Florida shall enter or be permitted to enter the prescription department. . . . Rule 215-1.24 provides, in part, as follows: Any person who receives a community pharmacy permit pursuant to Section 465.018, Florida Statutes, and commences to operate such a establishment shall, for the benefit of the public health and welfare, keep the prescription department of the establishment open for a minimum of forty (40) hours per week and sixty (60 percent) percent of the total hours the establishment is open each day. . . . Since Mrs. Rodriguez has been informed by the investigators of the restricted access requirement for the prescription department, she has not gone into the prescription department except when the licensed pharmacist has been present. Upon being informed by the investigators of the minimum-hour requirements, the respondent expanded the working hours of the licensed pharmacist in order to increase the number of open hours of the prescription department in order to meet the provisions of Rule 215-1.24. The Respondent's pharmacy meets the needs of the predominantly Spanish-speaking neighborhood by providing pharmacy services with a Spanish- speaking pharmacist.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that respondent violated the requirements of section 893.07(1)(b), Florida Statutes, and rules 215-1.14 and 215-1.24, Florida Administrative Code, as alleged in Counts I, II and IV of the Administrative Complaint, and that, pursuant to section 465.023(1)(c), Florida Statutes, respondent be placed on probation for two (2) years, with the following terms: Respondent shall be inspected two (2) times per year, and respondent shall pay the reasonable costs of such inspections. Respondent shall remit a fine of $500 to the Board of Pharmacy within forty-five (45) days of filing the final order. DONE and ENTERED this 28th day of January, 1986, in Tallahassee Leon County Florida. DIANE A. GRUBBS 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 28th day of January 1986.
Findings Of Fact The Respondent, Natalie Patton, is a licensed pharmacist and has been licensed since 1959. She is a graduate of Sanford University, Birmingham, Alabama, and was initially licensed in Alabama as a pharmacist. She has worked as a licensed pharmacist for twelve years in Highlands County in the vicinity of Sebring. She is licensed as a pharmacy consultant as well and has been employed at several hospitals and pharmacies in that geographical area. She opened her present pharmacy' business in November, 1978, in a rural area southwest of Sebring at the community of Spring Lake. Her's is the only pharmacy in seventeen miles and her business volume reflects the rural nature of her business location and clientele in that she fills an average of thirty-five to fifty prescriptions a day. On "Race Friday," the day prior to the Sports Car Race at Sebring, a man entered her pharmacy complaining of severe headache and allergy to fumes associated with the infield and pits at the racetrack. He asked for Darvon, explaining that this was the only medication successful in treating his headaches. He explained he was from another part of the State and had no way to contact his physician. She sold him a non-prescription drug. He came back the next day, the day in question, March 22, and explained that her suggestion that he go to the emergency room the day before was impractical because a newspaper ad he had seen described the emergency room as overloaded and turning patients away. He complained of a worsening headache. She testified that she felt sympathy for him and ultimately and reluctantly sold him, at her cost, four Darvon to be used that Saturday and four for that Sunday. The individual requesting the medication then revealed himself to be a Deputy Sheriff of Highlands County, who arrested her on the spot, charging her with dispensing the Darvon without a prescription in violation of the above authority. She ultimately was tried on the charges and convicted, but adjudication was withheld and she was placed on three years probation by the Circuit Judge. A second related criminal charge was ultimately dismissed. She has been under the direction of a probation officer since that time and must report all her activities and receive permission before traveling out of her county. She also has been required to pay fifty dollars a month to reimburse the public defender for his services on her behalf. She is still operating her business and her customers have professed loyalty to her and her business is still increasing in volume. She has never had any altercation with law enforcement authorities of any type in her past and has never been convicted of any felony or misdemeanor. With the agreement of counsel for the Petitioner, certain testimonial letters on her behalf from persons who were not in attendance at the hearing were admitted as composite exhibit 1. These letters attest to and establish the fact, in corroboration of her testimony, that she is a decent and useful citizen and that she was totally unaware that she was committing a felonious act. These letters corroborate her testimony and establish that she is a crucial asset to her rural community. She is depended upon by numerous citizens, many of whom are of advanced years and who require frequent medication and are unable to travel any great distance. She has obviously gone to great lengths to operate her business in a professional and compassionate manner even to the extent of delivering medications to senior citizens and others long after the closing hours of her pharmacy. These letters in support of her position also are replete with instances described where she adheres strictly to the dictates of the various physicians' prescriptions and refused on a number of occasions to prescribe medication without a prescription. There is no question that the evidence in this record establishes that the Respondent is clothed with the highest personal integrity and moral character and that the isolated incident when she dispensed medication in violation of the above authority is not characteristic of the regular and otherwise consistent manner in which she practices pharmacy and conducts her business. The Respondent's probation officer sent a letter which is incorporated in Respondent's Exhibit 1 attesting to her conscientious efforts to obey the law and her usefulness as a citizen. He expressed the belief that she was unaware that she was actually committing a crime when the subject violation occurred and that she was simply and compassionately attempting to help a customer in trouble. He is convinced that revoking her pharmacy license would serve no useful purpose and would indeed impose a hardship on the rural customers she serves. He firmly believes she would not consciously violate the law or purposefully commit an illegal act. The Respondent was authorized by the Circuit Judge in the Respondent's criminal proceeding to make the following statement on the record in this proceeding: In re Natalie Patton: In open Court, in disposing of this case, and putting Natalie Patton on probation without adjudication, I made note of the numerous letters I received from people in the community, urging the Court to be lenient. The Respondent then noted that there were a hundred and forty signatures on those testimonial letters. At the conclusion of the Respondent's case the Respondent requested that the penalty herein be limited to a letter of reprimand. The Petitioner introduced no evidence and otherwise took no position with regard to the question of an appropriate penalty.
Recommendation Having considered the foregoing findings of fact, conclusions of law, the candor and demeanor of the witness and the evidence in the record, it is RECOMMENDED: That Natalie N. Patton and Spring Lake Pharmacy remain licensed and that Natalie Patton be accorded a written reprimand by the Board regarding the subject violation and that she be placed on probation by the Board for a period of time coextensive with the probation imposed in the criminal proceeding related hereto during which time her conduct of the practice of pharmacy be subjected to periodic monitoring by the Board. DONE AND ENTERED this 2nd day of November, 1981, in Tallahassee, Florida. COPIES FURNISHED: William M. Furlow, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Michael J. Trombley, Esquire 329 South Commerce Avenue Sebring, Florida 33870 P. MICHAEL RUFF, 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 4th day of November, 1981.
Findings Of Fact At all times pertinent to this hearing, Respondent, M. J. Warhola, was a doctor of osteopathic medicine and properly licensed as such by the State of Florida by license number OS 0001256, issued in 1957. He has been practicing osteopathic medicine at his present location in Tampa, Florida, for the past 17 or 18 years. Respondent first started treating Pearl O. Knowles in 1965. Generally, she was suffering from severe diabetes and was overweight. He also, over the years, treated her for arteriosclerosis. Among the drugs he was prescribing for her during the 1979-1989 time period were Placidyl (sleeping pill), Verstran (tranquilizer), Triavil (antidepressant), Dilantin (anticonvulsant) Teldrin (antiallergenic), Donnatal (sedative), Synalgos (painkiller), Talwin (painkiller), various antibiotics, and such other substances as insulin, stool hardeners, vitamins, diuretics, antihistamines, and antiemetics. During the period from January, 1979, through December, 1981, prescriptions written by Respondent for these varying medications for Mrs. Knowles or her husband were filled by area pharmacies in accordance with the following chart: MONTH/YR TOTAL MRS. K MONTH/YR TOTAL MRS. K Jan. 79 11 4 July 80 22 15 Feb. 79 15 7 Aug. 80 15 10 Mar. 79 10 5 Sept.80 26 19 Apr. 79 14 11 Oct. 80 20 10 May 79 13 10 Nov. 80 21 16 June 79 10 8 Dec. 80 22 17 July 79 11 6 Jan. 81 16 11 Aug. 79 15 10 Feb. 81 15 12 Sept.79 13 10 Mar. 81 25 17 Oct. 79 15 6 Apr. 81 26 17 Nov. 79 7 5 May 81 21 10 Dec. 79 17 12 June 81 11 4 Jan. 80 12 8 July 81 23 8 Feb. 80 17 12 Aug. 81 25 23 Mar. 80 21 17 Sept.81 5 5 Apr. 80 17 14 Oct. 81 20 14 May 80 24 22 Nov. 81 4 2 June 80 27 21 Dec. 81 2 2 TOTAL: 588 400 Many of the above instances are refills of the same prescription. According to Respondent, some prescriptions were authorized five refills without contact with him. Some, such as Prescription #27162 for 100 Triavil, initially filled on December 1, 1979, was subsequently refilled at least 11 times, and three other separate prescriptions for the same drug were filled multiple times. From January, 1979, through September, 1980, a period of 20 months, 30 tablets each prescriptions for Placidyl tablets, written by Respondent for Mrs. Knowles, were filled 46 times for a total of 1,380 tablets. During the same period, Triavil prescriptions for 100 capsules each written by Respondent for Mrs. Knowles were filled 22 times for 3,200 tablets, Talwin at 100 tablets 13 times for 1,300 tablets, at least 10 prescriptions for either Tylenol #3 or Fiorinol #3, both with codeine, at 50 tablets each for the Fiorinol at least totalling more than 509 tablets, as well as all the others stated in paragraph 2 above. Mrs. Knowles admits taking too much medication, but claims it is not the fault of Respondent. Whenever Respondent saw her and gave her a prescription for any medicine, he would tell her what dosage to take. She would see the Respondent every two or three weeks and get a new prescription each time and would also give her prescriptions at her request without her going to the office personally. Regardless of what instructions Respondent would give her concerning the dosage of the various painkillers and "nerve medicines" he would give her, she often exceeded the directed dose either by accident or in an effort to relieve the extreme pain she was experiencing in her hands and feet. Not only did she get drug prescriptions from Respondent, but by her own admission, she also saw other doctors during the period from whom she got "pain pills," as well as taking those given to her on her release from the hospitals to which she was admitted. She recognized that she was taking too many drugs at the time, but the pain was severe and she felt it was required. During this same period of time, from mid-1979 on through early 1982, while Mrs. Knowles was seeing Respondent for her diabetes and other chronic ailments, she was admitted to several hospitals in the area. On June 11, 1979, she was admitted to the Brandon Community Hospital (BCH) in Brandon, Florida (Brandon is a small community east of Tampa), in a confused and disoriented state. The admission diagnosis was diabetes with electrolyte imbalance. The attending physician noted at the time that the patient "is somewhat dependent on drugs." Approximately two months later, on August 15, 1979, Mrs. Knowles was again admitted to BCH, this time for uncontrolled diabetes and overdosing her drugs including Placidyl and Fiorinol. Again, the attending physician noted the failure of the patient to take care of her diabetes, her drinking, and her drug dependency. Mrs. Knowles thereafter stayed out of the hospital for about a year until, on September 1, 1981, she was again admitted to BCH, again for her diabetes. Secondary diagnoses on this occasion were hypertension and taxciencephalopathy, a disorder of brain function. At this time, she was seen in the hospital by Dr. Mark Stern. Based on the lab work performed and examination by Dr. Stern and other specialists to whom she was referred, it was concluded that her condition, aside from the diabetes and hypertension, was related to her overuse of drugs such as Talwin, Valium, Triavil, and the like. She was again seen by Dr. Stern at BCH on October 24, 1981, when she was admitted for an unintentional drug overdose. A drug screen done at the time of admission revealed a Placidyl level of 69.4 (normal level is 0.5 to 10, with toxic levels being greater than 20). A repeat test six and a half hours later showed the level of Placidyl at 62.4. Other lab tests showed opiates, benzodiazepan (tranquilizers such as Valium and Librium), and salecylates. When she was admitted on this occasion, she had with her a box containing several medicine bottles. Notwithstanding Petitioner's allegation that "Said labels were not labeled by Respondent," the testimony of Deborah Ann Brown, Director of Pharmacy at BCH, to whom the box of bottles was given for identification, shows that only one of all the bottles did not have the appropriate markings on it. It also appears that some of the medicines in the box had been prescribed for Mrs. Knowles' husband, Ira. Dr. Stern again saw Mrs. Knowles when she was brought to BCH on January 6, 1982, complaining of weakness and difficulty in walking. Again, her history showed she was taking antidepressants and Placidyl for chronic insomnia. Dr. Stern recalls that Mrs. Knowles telephoned him on October 9, 1981, and requested prescriptions for Placidyl, Triavil, and Talwin, but he refused to prescribe them for her. He terminated his relationship with her in August, 1982. During the period she was his patient, however, he did prescribe for her such substances as painkillers, sleeping pills, and antianxiety drugs, the same generic types of drugs as prescribed by Respondent, by written prescriptions, some of which called for multiple refills. Though Mrs. Knowles advised Dr. Stern that she was being treated by Dr. Warhola, Dr. Stern did not discuss her with Dr. Warhola or even contact him. Even when Mrs. Knowles threatened to get drugs from Respondent when Dr. Stern refused to give her prescription over the phone in October, 1981, Dr. Stern still did not contact Dr. Warhola. Between the fourth and fifth BCH hospitalizations, on December 21, 1981, Mrs. Knowles was admitted to Tampa General Hospital (TGH) and was examined by Dr. Jeffrey L. Miller, a rheumatologist internist, at the request of her regular physician, Dr. Sugarman. When Dr. Miller first saw her, Mrs. Knowles was overmedicated. She was confused, and her speech was slurred. She indicated to Dr. Miller that she was taking Triavil and other drugs as well, such as Zomax and Placidyl, but refused to tell him all the drugs she was taking. Those she mentioned are addictive, and it appeared that she was addicted because she had been hospitalized for nonaccidental overmedication and because her condition was consistent with addiction. Mrs. Knowles denied having a drug problem. In Dr. Miller's opinion, however, Mrs. Knowles was not receiving the proper therapy. Her diabetes did not require the drugs she was getting. Her other symptoms, in his opinion, did not justify the apparent liberal prescriptions she was getting and should have been treated with psychotherapy rather than drugs. In his opinion, therapy should be tailored for an individual like Mrs. Knowles so that the medication is limited and regulated to prevent addiction and the buildup of tolerance to a drug, which results in larger and larger doses. The evidence also shows, however, that Mrs. Knowles was a difficult patient. Dr. Sugarman was having difficulty with her and requested the consult by Miller. What must also be considered is that Mrs. Knowles' leg, about which she constantly complained of the pain, was subsequently surgically removed in 1982 as a result of her diabetes. The pain associated with this condition leading up to the amputation was real and required relief to some degree. In any case, Dr. Miller did not ever discuss Mrs. Knowles with Respondent or advise him of her addiction. Mrs. Knowles still receives painkillers and "nerve medicine" from her current physician, Dr. Sugarman, whom she sees every two weeks. She stopped seeing Dr. Warhola when she started seeing Dr. Sugarman, who, she felt, was more current in some of her problem areas than Respondent. She did not leave Respondent because she was dissatisfied with him. In fact, he was the only one who helped her blood clots. According to Respondent, he gave Mrs. Knowles the Placidyl for sleep because she had a lot of pain as a result of her diabetes and needed it to help her sleep. At this same time, Mrs. Knowles' husband was a severe alcoholic and, since she was under a lot of strain because of that, he gave her the drug to help her sleep. The call he got from Dr. Stern on October 26, 1981, when she was in BCH, indicating she was mixing drugs, was the first indication he had that she was abusing drugs. He told Stern she was not to get any more, and he, Respondent, has not prescribed any for her or seen her since. In fact, he was not informed of her hospitalizations in June or August, 1979, or in September, 1981. It is, even by the testimony of Petitioner's expert, Dr. Gladding, not uncommon in Florida for M.D.s to admit a D.O.'s patient to a hospital and not ever notify the D.O. of that fact. Mrs. Clifton M. Wood of Winter Haven, Florida, was first taken to see Respondent for a diet regimen in 1980. On the first visit on February 7, 1980, he gave her a physical examination which included a complete laboratory workup, cardiogram, and weight and pressure check. He gave her some pills which had instructions for use on the bottle, but did not tell her what they were. Each time she came to his office for a visit thereafter, on a monthly basis, either Respondent or his nurse would weigh her and take her blood pressure and adjust her medication as required. During the course of treating Mrs. Wood, Respondent gave her phedymetrazine, an appetite suppressant, methahydrine for high blood pressure, Donnatal, and vitamins and minerals. He gave Mrs. Wood only the drugs he felt she needed in the amount she needed. Mrs. Wood was admitted to Winter Haven Hospital on October 26, 1980, because a neighbor who was concerned about her brought her in. At the time, Mrs. Wood had trouble with dizziness, her balance, and falling. Before this incident, however, Respondent on one or more of his visits, had given her pills for her blood pressure and potassium pills for her to take in water. According to Dr. Gordon Rafool, who had also treated Mrs. Wood since 1979 and who admitted her to the hospital in October, 1989, at the time of admission, she was, among other things, dehydrated and had an electrolyte imbalance (lack of body salt, specifically potassium), the latter possibly being caused by the intemperate use of a diuretic. A diuretic is often used in cases of heart failure, high blood pressure, and, though not recommended, weight reduction, to get rid of body water. Since it was important to know what medicines Mrs. Wood was taking to help determine the reason for her condition, Dr. Rafool and other hospital personnel tried to get an identification of the drugs in Mrs. Wood's possession when she was brought in. The hospital pharmacy could not identify them, and no drug screen was done, but Dr. Rafool obtained a written authorization of Respondent to permit Respondent to release any information regarding drugs dispensed or prescribed to the patient by him. This authorization was forwarded to Respondent's office with a request for Mrs. Wood's medical records, but they were never released. Dr. Warhola's office manager, Mrs. Zacchini, states the request and authorization on Mrs. Wood were received, but were apparently inadvertently filed in the office record without the requested records being sent out. Though Dr. Rafool says that numerous follow-up calls were made to Respondent's office, Mrs. Zacchini denies any were received from either the hospital or Dr. Rafool. In any case, there is no evidence to indicate any calls were made to or received by Respondent directly, and he denies every having received any. Mrs. Wood still considers Respondent to be a good doctor, but she has not gone back to see him since her release from the hospital because Dr. Rafool told her to stay away from him. She has been seeing Dr. Rafool, who has been treating her with pills for her arthritis and high blood pressure. Petitioner presented the deposition of Dr. Lloyd D. Gladding, D.O., over the partial objection of Respondent, whose objection was not to the use of the deposition, but to specific parts thereof based on particular grounds. For example, Respondent objected to Dr. Gladding's testifying as an expert because, he contended, there had been no showing by Petitioner that the witness's experience compares to that of Dr. Warhola. He contends the witness does not practice in the same geographical area nor is there a showing he is a similar health care provider with a similar specialty or a similar type practice. However, Dr. Gladding's curriculum vitae, admitted without objection, shows he is currently co-chairman of a family practice seminar in his area and a clinical preceptor (teacher) at an osteopathic medical school and has been engaged in a family practice in the Fort Myers area since 1978. This area is geographically not far removed from the Tampa Bay area (the distance is not significant) and there is no showing that the patient conditions involved in the two cases at issue would or could be affected significantly by the geographical location of the patient or that treatment of these conditions varies greatly from location to location. In fact, according to this witness, he finds patients from widely differing areas (Pennsylvania, where he was trained, as opposed to Florida, where he practices) to be the same. Accepting the witness as an expert, then, with reference to Mrs. Knowles and her condition, he has had patients with a similar series of health problems where the patient was placed on multiple drug regimens. Sometimes, these patients developed drug dependencies for the different medications he prescribed. In the case of Mrs. Knowles, based on the number of Placidyl prescribed by the Respondent over about a year, she received enough to take two per day, which would constitute 1,500 mg. of the drug per day (two tablets of 759 mg. each). The drug company's recommended daily dose is between 590 and 750 mg. given at bedtime, with an additional 109 to 200 mg. later on, if needed. The fact that Mrs. Knowles was also getting other drugs, including a different type of sleeping pill, makes Dr. Gladding feel the prescriptions by Respondent were excessive. He admits, however, he does not know how much pain the patient was in and this makes it difficult to render an opinion. Because of this, he cannot unequivocally say that the dosage prescribed was excessive. Good practice is to prescribe as few Schedule II drugs as is possible. However, without knowing the patient, her attitude, and her actual condition, an opinion as to the appropriateness of the drugs prescribed, unless clearly inappropriate, would be merely guesswork. As to the patient Mrs. Wood, Dr. Gladding could not read Dr. Warhola's notes of what drugs he gave her. Therefore, in analyzing Respondent's prescriptions, he relied on and referred to a federal drug analysis of the unmarked drugs she got from Respondent as including barbiturates or their derivatives. This analysis was not introduced into evidence, and Dr. Gladding's reference to it is hearsay which cannot, by itself and without other independent evidence of the identity of the drugs, support a finding of fact even though it would appear some were drugs that would not be used in weight control. However, there were drugs identified independently, such as the potassium replacement and the weight reduction drug, which were appropriate and, in addition, the tranquilizer could also be appropriate. In any case, Dr. Gladding does not know what Mrs. Wood told Respondent about the problems she was having sleeping. If she did tell him this, even the barbiturates could be appropriate. Dr. Gladding has also been confronted with a situation where a patient of his has been hospitalized and the hospital calls him for information on the patient on an emergency basis. He knows, he says, everyone in the local hospitals and generally provides the requested information on the spot without a formal release. He is more concerned with the patient's welfare than with technicalities. However, in the case of Mrs. Wood, there was not an emergency situation and there was no showing Respondent was ever personally contacted. In addition, there was evidence of only one written release, not three, as reflected by the witness.
Recommendation Based on the foregoing, it is, therefore, RECOMMENDED: That the Administrative Complaint filed herein against Dr. Warhola be dismissed, but that he be officially reminded of the necessity to conservatively prescribe controlled substances in the course of his practice. RECOMMENDED this 6th day of March, 1984, in Tallahassee, Florida. ARNOLD H. POLLOCK 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 6th day of March, 1984. COPIES FURNISHED: James H. Gillis, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32391 Gerald Nelson, Esquire 4950 West Kennedy Boulevard Suite 693 Tampa, Florida 33609 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee. Florida 32301 Ms. Dorothy Faircloth Executive Director Board of Osteopathic Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
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
