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
Findings Of Fact Respondent is a medical doctor, licensed to practice in Florida, and holds license number ME 0009310, issued by Petitioner. Respondent specializes in family practice and has been board certified by the American Academy of Family Physicians since 1974. Percodan is the manufacturer's brand name for oxycodone, which is a Schedule II controlled substance pursuant to Chapter 893, F.S. 2/ It is a drug used for the relief of pain, a synthetic analgesic, and is both a physically and psychologically dependent producing drug. It can cause drowsiness, urinary retention, nausea, vomiting, and interacts unfavorably with other sedative drugs, and is considered a depressant. On December 30, 1966, Evelyn Milstead, a 30 year old woman, came to Respondent's office complaining of nausea and a rash in her mouth. Respondent conducted a physical examination, took her medical history and thereafter prescribed tigan for the nausea. Ms. Milstead became a regular patient of Respondent's and he continued treating her for various ailments over a period of years. During the course of Respondent's treatment, Milstead developed a chronic urinary tract infection and kidney condition in which she passed kidney stones. On occasion Milstead was treated by Dr. Gillespie, a specialist in the field of urology for her kidney condition. In 1978, Respondent also referred instead to the Ochsner Clinic for evaluation of her urinary tract and kidney problems. She was evaluated at Ochsner Clinic and received prescriptions for darvocet, a pain medication, and keflex, an antibiotic, and was told that she would continue to have a chronic kidney problem. Over the years, Milstead was hospitalized several times by Dr. Gillespie for treatment of her kidney condition. The testimony of Dr. William H. Nass and Dr. Robert P. Johnson established that Respondent's initial prescriptions of percodan to Milstead were appropriate. However, Respondent's percodan prescriptions to Milstead eventually became inappropriate. Specifically, the prescriptions for 2,668 percodan tablets between August, 1980 and November, 1982, were established as excessive. On July 30, 1977, Bruce White, a 25 year old male, came to Respondent for medical treatment for headaches and thereafter returned to Respondent for treatment of various medical problems. Mr. White's wife, Vicki White, and their children were also seen by Respondent as their family doctor. On May 18, 1981, White came to Respondent complaining of neck and back pain from an automobile accident in which he also fractured his left lower leg. Respondent noted that White had been seen by a neurologist and an orthopedic surgeon for his head and leg. In addition to other medication, Respondent prescribed percodan to White for pain. White had also developed arthritis in his left leg, as a result of the car accident and fracture, and on one occasion was hospitalized for swelling of his left leg. Respondent referred White to Dr. Tippett, a neurosurgeon, concerning his headaches and to Dr. Graybiel, a rheumatologist, concerning his arthritis. However, White continued to see Respondent as his medical doctor because his work schedule on an offshore oil rig would only permit Saturday appointments with his doctor and Respondent's offices are open on Saturday mornings. White also found it difficult to pay the fees charged by specialists. Between May 8, 1981 and September 30, 1982, Respondent prescribed 780 percodan tablets for Bruce White. The testimony of Dr. Nass and Dr. Johnson established that Respondent's initial prescriptions of percodan to White were appropriate. However, the percodan prescriptions to White became inappropriate over time due to their excessiveness. The seriousness of this lapse is underscored by Respondent's failure to try other pain alleviating measures and failure to investigate abuse possibilities. On October 18, 1979, Vicki White, the wife of Bruce White, a 23 year old woman, came to Respondent's office seeking treatment. She complained of migraine headaches and stated that her father was in the hospital with cancer. She also stated that she had seen Dr. Eyser, a neurosurgeon, for her headaches. Respondent prescribed wygesic for her pain. She subsequently returned to Respondent for treatment of various complaints including chronic migraine headaches, colds, and a dislocated right shoulder. Initially, Respondent prescribed norcet for relief of this pain, and on July 31, 1981, first prescribed percodan for her migraine headaches. Respondent prescribed percodan on other occasions in response to her complaints of pain from migraine headaches and back strain. Respondent considered referring her to a neurologist for the headaches but White stated that she could not afford to see a specialist. Respondent prescribed 590 percodan tablets for Vicki White between July 31, 1981 and September 22, 1982. Percodan is an appropriate and acceptable medicine for the relief of migraine headaches, and Respondent's initial prescription of percodan to Ms. White was appropriate. However, his prescriptions became excessive over time since percodan is not to be used for long term treatment of migraine headaches. On September 7, 1982, M. D. Medlen, an Escambia County Deputy Sheriff, went to Respondent's office as an undercover police officer, under the assumed name of Donna Slay. She had been asked by Robert Powers, a narcotics officer with the Escambia County Sheriff's Department and Charles Deckard, an investigator with the Department of Professional Regulation, to go to Respondent's office in an undercover capacity and attempt to obtain a prescription for percodan. Medlen/Slay first gave general information to the receptionist, including identification, in the name of Donna Slay, chief complaint of a backache, previous illnesses, drug allergies, address, social security number, and insurance information. Medlen/Slay was shown to an examination room where her blood pressure and weight were taken by the nurse and a urinalysis was performed. Respondent then came in and asked Medlen/Slay what her problem was. She informed him that she had been pushed into a wall during a fight, and had injured her back. Respondent checked her pulse, did a range of motion test, and checked the alleged injured area by palpation. Each time Respondent pressed on the alleged injured area, Medlen/Slay told him it hurt. Respondent did not visually inspect the alleged injured area but asked Medlan/Slay if there was a bruise and she said no. In order to get the percodan, Medlen/Slay told Respondent that she had injured her back one other time and a doctor in Louisiana had prescribed percodan for that injury. Respondent asked how long ago Medlen/Slay had taken the percodan and she said one year ago. Respondent discussed the dangers of drug addiction with Medlan/Slay and then prescribed 20 tablets of percodan for pain and 30 tablets of indocin to reduce inflammation. Upon leaving Respondent's office, Medlen/Slay did not fill the prescriptions but turned them over to Deckard. Percodan is an acceptable medicine for back and shoulder pain. However, Respondent should have considered the possibility of fracture, visually examined the area to ascertain the presence of a hematoma (blood clot) and listened to the patient's chest to determine the presence of lung injury. Respondent did not perform an appropriate examination prior to prescribing percodan, and the prescription was therefore inappropriate. Respondent used poor judgment in his excessive prescriptions of percodan to the patients discussed herein. However, there is no evidence that Respondent prescribed the percodan for personal financial gain or that any patient was injured by Respondent's prescribing practices. The testimony of the expert witness established that the records maintained on these patients were inadequate. Frequently, the only notation for a given visit was the prescription for percodan, with no evaluation of the patient's condition. Further, Respondent's patient records did not even list all the percodan prescriptions issued. Thus, these records essentially reflect partial inventories of prescriptions issued, and do not justify the course of prescribing, which is important to the safe practice of medicine.
Recommendation Based on the foregoing, it is RECOMMENDED that Petitioner enter a final order placing Respondent on probation for a period of five years, require that Respondent practice under the supervision of another physician to be named by Petitioner during the initial year of his probation and that Petitioner restrict Respondent's license against prescribing Schedule II controlled substances while he is under such supervision. 4/ DONE and ENTERED this 24th day of April, 1984 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 24th day of April, 1984.
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.
