Elawyers Elawyers
Washington| Change
Find Similar Cases by Filters
You can browse Case Laws by Courts, or by your need.
Find 49 similar cases
BOARD OF PHARMACY vs. MARIA C. PEREZ, 83-002819 (1983)
Division of Administrative Hearings, Florida Number: 83-002819 Latest Update: Jun. 22, 1984

Findings Of Fact At all times material hereto, Respondent Maria C. Perez has been licensed as a pharmacist under the laws of the State of Florida, having been issued license number 0018025. At all times material hereto, Respondent Perez has been the managing pharmacist at Respondent San Lazaro Pharmacy. At all times material hereto, Respondent San Lazaro Pharmacy has been the holder of a permit to operate a community pharmacy under the laws of the State of Florida, having been issued permit number 0002864. At all times material hereto, Olegario Cepro (or Cepero) was employed at Respondent pharmacy. At no time material hereto was Cepro licensed as a pharmacist or registered as a pharmacy intern in the State of Florida. On March 1, 1983, Georgina Jorge, an investigator with the Department of Professional Regulation, entered the Respondent pharmacy. Jorge asked Cepro for 30 Berocca tablets, 10 Librax capsules, and 5 Darvon Compound capsules. Cepro went into the dispensary department and thereafter delivered to Jorge 45 pills. At no time during this transaction did Jorge present Cepro with a prescription. On March 1, 1983, the pills received were taken to the Metropolitan Dade County Crime Laboratory. A subsequent chemical analysis of the pills revealed the presence of the controlled substance known as chlordiazepoxide, the active ingredient in Librax, a medicinal drug requiring a prescription for dispensing. Another sample which was analyzed revealed the presence of the controlled substance known as dextro propoxyphene, the active ingredient in Darvon Compound, a medicinal drug requiring a prescription to be dispensed. The suspected Berocca was not analyzed. On March 8, 1983, Jorge returned to the Respondent pharmacy. She asked Cepro for 10 penicillin tablets, 20 Valium tablets, and 10 Darvon Compound capsules. Cepro obtained from the pharmacy dispensary and gave to Jorge 10 tablets which appeared to be penicillin, 20 tablets which appeared to be Valium, and 20 capsules which appeared to be Darvon Compound. At that time, Respondent Perez was in the pharmacy dispensary. At no time during this transaction did Jorge present Cepro with a prescription. On March 8, 1983, the above substances were taken to the Metropolitan Dade County Crime Laboratory. A subsequent chemical analysis of the pills revealed in one sample the presence of penicillin, a medicinal drug requiring a prescription for dispensing. Analysis of another substance revealed the presence of the controlled substance diazepam, the active ingredient in Valium, a medicinal drug requiring a prescription for dispensing. On March 25, 1983, Jorge went to the Respondent pharmacy and asked Cepro for prices on bottles of Valium, Mebaral, Lomotil, Ritalin, Trofanil, and Lasix. Prices were quoted to Jorge by Cepro. Thereafter, Cepro delivered to Jorge 20 apparent Valium tablets, 36 apparent Ritalin tablets, 250 apparent Mebaral tablets, and 20 apparent Darvon Compound capsules. On this occasion, Jorge observed Respondent Perez, the licensed managing pharmacist, in the dispensary. At no time during this transaction did Jorge present Cepro with a prescription. On March 25, 1983, the substances which Jorge had received at the Respondent pharmacy were taken to the Metropolitan Dade County Crime Laboratory. A subsequent chemical analysis of the substances revealed the presence of the controlled substance known as methylphenidate, the active ingredient in Ritalin, which is a medicinal drug requiring a prescription to be dispensed. Methylphenidate is a Schedule II controlled substance pursuant to Chapter 893, Florida Statutes. Laboratory analysis of additional substances received from the March 25, 1983, transaction revealed the presence of the controlled substance known as mephobarbital, the active ingredient in Mebaral, a medicinal drug requiring a prescription for dispensing. In addition, one of the 20 capsules received was analyzed and revealed the presence of the controlled substance known as propoxyphene, the active ingredient in Darvon Compound, which is a medicinal drug requiring a prescription for dispensing. On March 28, 1903, Jorge went to the Respondent pharmacy once again. She asked Cepro for 20 Valium tablets and 20 Lomotil tablets. Jorge saw Respondent Perez in the prescription department. Cepro went into the prescription or dispensary department and returned with suspected controlled substances. At no time during this transaction did Jorge present Cepro or Respondent Perez with a prescription. On March 28, 1983, the suspected controlled substances were taken to the Metropolitan Dade County Crime Laboratory for analysis. A subsequent chemical analysis of the tablets revealed the presence of the controlled substance known as diazepam, the active ingredient in Valium, a medicinal drug requiring a prescription for dispensing. On March 28, 1983, an audit of the controlled substances was conducted at the Respondent pharmacy by Edward Bludworth, an investigator with the Department of Professional Regulation. That audit revealed that Respondents could not provide prescriptions or other documentation to show the dispensing of 41 Darvon Compound-65, 1,005 Valium 5 mg., 801 Valium 10 mg., 280 Tranxene 3.75 mg., 33,451 Talwin 50 mg., and 20 Talwin injectable vials. Darvon, Tranxene, Valium, and Talwin are all compounds containing controlled substances as defined in Chapter 893, Florida Statutes. Petitioner presented no evidence concerning the allegations of Count III [sic II; paragraphs 13, 14, 15, and 16] of the Administrative Complaint filed against Respondent Perez in DOAH Case No. 83-2918.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered dismissing Count III of the Administrative Complaint filed against Respondent Maria C. Perez, finding her guilty of Counts I and II of the Administrative Complaint filed against her, and revoking her license to practice pharmacy in the State of Florida. It is further RECOMMENDED that a Final Order be entered finding Respondent San Lazaro Pharmacy guilty of each and every count in the Administrative Complaint filed against it and revoking its permit to operate a community pharmacy in the State of Florida. DONE and RECOMMENDED this 27th day of March, 1984, in Tallahassee, Leon County, Florida. LINDA M. RIGOT 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 27th day of March, 1984. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 A. M. Schwitalla, Esquire 135 Almeria Avenue Coral Gables, Florida 33134 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Wanda Willis, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301

Florida Laws (5) 120.57465.015465.016465.023893.04
# 1
DEPARTMENT OF HEALTH, BOARD OF PHARMACY vs KENNETH M. LOOMIS, 01-003074PL (2001)
Division of Administrative Hearings, Florida Filed:Orlando, Florida Aug. 02, 2001 Number: 01-003074PL Latest Update: Jan. 10, 2025
# 2
BOARD OF MEDICAL EXAMINERS vs. JAY S. REESE, 83-000355 (1983)
Division of Administrative Hearings, Florida Number: 83-000355 Latest Update: May 08, 1990

Findings Of Fact Respondent, Jay S. Reese, is a physician in family practice in Temple Terrace, Florida. He holds license number ME 0014119 issued by Petitioner, Department of Professional Regulation, Board of Medical Examiners. Reese graduated from the Indiana University of Medicine in 1961. He became licensed in the State of Florida in March 1969 and has practiced in the Tampa area since 1972. He is on the active medical staff of the University Community Hospital in Tampa and enjoys an excellent professional reputation with his peers. He has been considered by some to be an "outstanding physician" in his field. Indeed, one of those physicians who testified against Reese in this proceeding characterized him as being a "very capable physician." Respondent has had a long and sincere interest in drug abuse problems since the late 1960s when he served in the U.S. Navy. Thereafter, he became affiliated with a drug clinic in Winter Haven, Florida, which provided assistance to drug abusers. When he moved to Tampa in 1972 he continued his efforts to fight drug abuse by serving on the Department of Health and Rehabilitative Services Advisory Council for Drug Abuse, and on the board of the Drug Abuse Comprehensive Coordinating Office (DACCO) for Tampa and Hillsborough County. He was also on the steering committee which founded the Hillsborough County Alcohol Community Treatment Services in 1979. He is in frequent contact with various law enforcement authorities and judges in Hillsborough County in association with this work. Because of his involvement with drug and alcohol abuse clinics, Reese has often taken care of patients who have had alcohol or drug addiction or habituation problems. This group of patients is considered to be the most difficult to treat. It is not uncommon for such patients to claim they lost their prescriptions, alter prescriptions, steal blank pads from a physician's office, buy and sell drugs on the streets, or to be seeing more than one physician at the same time. In view of this, few physicians are willing to assume the inherent difficulties associated with a former addict or alcoholic. Nonetheless, Reese has opened his doors to the former drug addicts and alcoholics who are in need of medical treatment because of his concern and interest in this field. In light of his longtime volunteer work in the drug abuse area, it came as a surprise to Reese when petitioner filed a lengthy administrative complaint charging him with prescribing excessive and inappropriate amounts of controlled substances to numerous patients for non-medically justified purposes and not in the course of his professional practice. 1/ This prompted the instant proceeding. As narrowed during the course of the hearing and by subsequent pleadings of petitioner, the charges involve thirteen patients treated by Reese at varying times between 1979 and 1982. Most, if not all, had a history of prior alcohol or drug addiction or habituation problems. Nonetheless, they had legitimate medical problems requiring the attention and care of a competent physician. The quantities and duration of controlled substances given to the thirteen patients are set forth in petitioner's exhibits 2-8 and 10-15 received in evidence. Nine patients received controlled substances (dilaudid, percodan, demerol, mequin and percocet) for the treatment and management of pain, three were given quaalude exclusively, and a fourth received both quaalude and sapor. The latter four patients suffered from legitimate sleeping problems which necessitated the prescriptions in question. In treating these patients, Reese acted prudently and honestly, and used his best medical judgment to select the type and amount of drug prescribed. All were given thorough physical examinations and necessary periodic follow-up checks. Those patients for whom Dr. Reese prescribed painkilling controlled substances had various ailments which inflicted pain on the patient in varying degrees of severity and duration. All medical problems were legitimate in nature, and the testimony did not establish otherwise. Dr. Reese's treatment was in accord with mainstream medical opinion that the utilization of controlled substances in the management of patient pain is appropriate. The prescription of controlled substances for various types of pain will depend on the severity of the pain and the response of the individual, among other factors. Authoritative medical literature declares that pain should be treated and should be treated early. In the absence of an alternative therapy, narcotic drugs should not necessarily be withheld from the patient. Each patient must be individually evaluated and continually evaluated during the doctor-patient relationship. The results of such treatment should be continually monitored. Because pain can be psychologically and physically debilitating, it should be brought under control as quickly as possible. To do so requires a subjective evaluation by the physician of the patient since there is no prescribed or defined procession through which a physician goes in determining the strength of pain medication. Generally, a doctor will prescribe smaller amounts of medication when first treating a patient, and once he gets to know the patient and his condition, a physician will schedule longer intervals between visits and larger quantities of drugs with more frequent refills. This is true since once a situation is under control, there is no reason to have the patient come to the office on a frequent, recurring basis. In treating pain, a drug of greater potency and potential for abuse should not be ignored in favor of a less potent drug, simply by virtue of the former drug's potential for abuse. In this regard, a physician achieves a better pain control with Schedule II medications than with Schedule III medications. The bottom line is the treating physician's medical judgment, that is, his judgment as to how severe the pain might be as he interprets it and what medication can achieve the best results. Pain control is the most difficult area to quantitate by virtue of the manner in which patients react to pain under medication. The prescription of drugs by a competent physician for the management of pain is a legitimate medical objective. The use of quaaludes for sleeping disorders was shown to be medically justified. Although some physicians do not ascribe to its use, it is nonetheless an appropriate drug for certain diagnoses, and was not shown to be inappropriate for patient numbers 5, 7, 13 and 14 as to either quantity or duration. Petitioner presented the testimony of two physicians who were accepted as experts for this proceeding. Their evaluation of the treatment given by Dr. Reese was based only upon a review of the patient records. They did not interview the patients, or meet with Dr. Reese to discuss his prescribing regimen. They had never actually seen or treated the patients. They generally concluded that Reese had not acted as a reasonably prudent physician or in accord with the level of care, skill and treatment which is recognized by a reasonably prudent physician in the Hillsborough County area. In short, they supported the relevant allegations in the administrative complaint. In contrast, experts presented by respondent painted a completely different picture and found no violations of applicable statutes, rules or standards of conduct. Indeed, they praised respondent for his willingness to treat this most difficult type of patient, and his dedication to the medical profession. It is noteworthy that the experts on both sides had minimal experience in treating patients who abuse alcohol and drugs, and in any event far less than the experience of Reese. It is a well-accepted fact in the medical community that as between two equally competent physicians, one of whom treats the patient and one of whom looks at records after the fact, the former physician will have substantially greater knowledge and "feel" of the treatment result than one merely looking at records. Given this fact, and the more persuasive testimony of respondent's experts, it is found that no deviation from the level of care, skill and treatment of the patients in question has occurred. It is further found that the drugs were in appropriate quantities and duration, were for medically justifiable purposes, and were not prescribed outside the course of Reese's medical profession.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that all charges against Dr. Jay S. Reese be DISMISSED with prejudice. DONE and ENTERED this 10th day of February 1984, in Tallahassee, Florida. DONALD R. ALEXANDER 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 10th day of February 1984.

Florida Laws (2) 120.57458.331
# 4
BOARD OF MEDICAL EXAMINERS vs. RICHARD STEPHAN FLATT, 80-001886 (1980)
Division of Administrative Hearings, Florida Number: 80-001886 Latest Update: Aug. 29, 1990

Findings Of Fact Richard Stephan Flatt, M.D., Respondent, is licensed by the Board of Medical Examiners, Department of Professional Regulation (Petitioner) as a medical doctor and was so licensed at all times here relevant. Respondent has been a Board certified Dermatologist since 1957 and has practiced Dermatology in Sarasota for some 20 years. He is 54 years old. Tana Williams was a patient of Respondent in 1971 when he first treated her for warts, and he also treated Ms. Williams' daughter. Afterward she left Sarasota but returned in 1975 or 1976, at which time she was divorced. She visited Respondent's office for treatment of warts on 5 April 1976. Her appointment was near the close of Respondent's office hours. During this visit she told Respondent she was divorced; that she liked older men; and that she would like to see him socially. He suggested she come back to the office after 5:30 p.m. when his nurse normally departed. Upon her return after 5:30, Respondent and Ms. Williams discussed an arrangement whereby he would contribute $250 per month towards her support and spend weekends at the apartment she would occupy. According to Respondent's testimony, at this time he was going through a mid-life crisis and was delighted with the prospects of being desired by a woman 23 years his junior. Some two weeks later the first weekend was shared. Although the situation was very satisfactory to Respondent, the $250 per month was insufficient even to pay the rent, let alone satisfy Ms. Williams' money requirements. Accordingly, Respondent found the liaison was costing more than he could fund from his ready cash. After the 5 April 1976 visit, Ms. Williams did not again visit Respondent's office, or consider herself Respondent' s patient. In addition to cash, Ms. Williams also wanted drugs for her nervous condition and Respondent began supplying her with Quaaludes in the latter part of 1978. By 1979, Ms. Williams was psychologically dependent on Quaaludes and was taking 10 to 12 per day. As Respondent became more financially strapped the Quaaludes were provided for the additional purpose of being converted by Ms. Williams into cash to help maintain her life style. In 1976 Respondent began ordering Quaaludes and Preludin from New York drug houses under his DEA authorization. The Quaaludes started out in quantities of 200 every few months but increased to 1,000 nearly every month by the end of 1979. Most, if not all, of the 11,000 300 mg. Quaaludes Respondent ordered on an Official Order Form for Controlled Substances were given to Ms. Williams. In addition, Respondent ordered Preludin which he also gave to Ms. Williams. Both Preludin and Quaaludes are Class II controlled substances. Due to Ms. Williams' increasing dependence on Quaaludes, nearly half of these drugs given her by Respondent were taken by her. Petitioner presented no evidence that Preludin was wrongfully prescribed or abused. During the nearly four years the relationship continued, several interruptions occurred, due largely to Ms. Williams' living with other men, one of whom she married for a short period of about two months. During the periods Ms. Williams was living with other men, she would contact Respondent to continue or renew their liaison and even threatened suicide and to publicize their relationship to his wife if he did not continue to see her. In the latter months of their association, assignations were arranged at motels at which Respondent gave Ms. Williams money and/or drugs in exchange for sex. In addition to supplying Ms. Williams with drugs obtained on Official Order Forms, Respondent also wrote prescriptions in Ms. Williams' name, in the names of his children, or in the name of a fictitious person. Those prescriptions written in names other than Ms. Williams, Respondent took to Wallpole's Pharmacy personally and picked up the drugs. By this procedure from late 1978 through 1979 Respondent acquired an additional 1,249 300-mg. Quaaludes, 150 Preludin Endurettes, and 100 Preludin tablets which he gave to Ms. Williams. Using a confidential informant, the Sarasota police made two controlled buys of Quaaludes from Ms. Williams and on one of these occasions the informant was wired for sound so his conversations with Ms. Williams could be monitored. With information received from the confidential informant and a surveillance of Ms. Williams' residence, the police became aware that Respondent was Ms. Williams' supplier of drugs. On the morning of 8 February 1980, Ms. Williams was arrested at her home on charges of possession and sale of controlled substances. After being advised of her rights, she was taken down to the State Attorney's office where she was told that she could get up to 10 years in prison for possession and sale of drugs, but that if she cooperated with the police in their case against Respondent, the State Attorney's office would recommend probation rather than jail when she was sentenced. Prior to the arrest of Ms. Williams the Sarasota Police, state and federal drug authorities were aware of Respondent's involvement and were investigating. Respondent, too, was aware of his increasing vulnerability to criminal prosecution and requested a pharmacist to pass the word to the proper authorities that he would like to surrender his DEA certificate, under the authority of which he ordered controlled substances. On February 12, 1980 federal, state and local authorities, armed with information that Respondent had ordered some 11,000 Quaaludes from three New York drug companies during the period from 1976 to the present, visited Respondent's office, told him he was suspected of narcotics violation, read him his rights and asked to see his records. Respondent cooperated fully with the authorities and presented his records which confirmed that Respondent could not account for more than 10,600 Quaaludes during the period from 1976 to the date of the inspection. Respondent made a voluntary statement to the police in which he acknowledged many of the facts noted above. He also voluntarily surrendered his narcotics license. On 22 May 1980, Respondent pleaded guilty in the Circuit Court in and for Sarasota County of two counts of possession of methaqualone and two counts of sale of methaqualone. Adjudication of guilt was withheld, but the Court sentenced Respondent to probation for a period of three years and a $5,000.00 fine on each of the two counts of possession and sale.

Florida Laws (5) 120.60458.329458.331475.25893.13
# 5
BOARD OF NURSING vs. LOIS E. ANDERSON BAILEY, 83-001948 (1983)
Division of Administrative Hearings, Florida Number: 83-001948 Latest Update: Oct. 04, 1990

Findings Of Fact At all times pertinent to the issues contained herein, Respondent, Lois E. Anderson Bailey, was a licensed practical nurse in the State of Florida under license number 12519-1. During the period between July, 1982 and January, 1983, and for an unknown period both before and after that time, Dr. Allan R. Varraux was a pulmonary specialist who, as a part of his practice, performed bronchoscopies at ORMC. As a routine part of this practice, Dr. Varraux utilized a cocaine solution to spray the back of the throat of his patients as an anesthetic prior to inserting the bronchoscope. Cocaine is also used as an anesthetic after the bronchoscope is inserted because it lasts between one-half an hour to forty-five minutes as opposed to xylocaine which lasts only fifteen minutes or so. Dr. Varraux also prefers to use cocaine over xylocaine because the latter often causes spasms in the patient. During this period, Dr. Varraux knew the Respondent, who was nursing supervisor of the Endoscopy section at the time, and discussed with her the controls for the use of cocaine for this purpose because cocaine is a controlled substance. At no time did Dr. Varraux ever discuss with Respondent the potential for the substitution of xylocaine for cocaine in this procedure nor did he ever approve its substitution. On or about January 18, 1983, Dr. Varraux wrote a letter to Mr. Holton, Director of the hospital pharmacy, asking for a survey of cocaine use at ORMC. He did this because of a survey done at another hospital at which he also practiced with which he was familiar to be sure that the amount of cocaine he was using was reasonable. The audit revealed that at the time in issue here, no cocaine was dispensed by the pharmacy for the Endoscopy section. Dr. Varraux considered this odd because he was ordering cocaine solution for the bronchoscopies he was performing and as a result, some cocaine should have been issued. He subsequently found out that xylocaine was being substituted for cocaine. He had not authorized the substitution and was greatly concerned because of the potentially serious impact the substitution might have on a patient if the patient were allergic to xylocaine and the physician did not know that the substitution had been made. In his opinion, it is not good medical practice to substitute xylocaine for cocaine without the doctor's orders and without informing the physician of the change. In practice, the cocaine is injected with a syringe into the apparatus being utilized during the bronchoscopy. At that point, the order for the use of cocaine is a verbal order which is, thereafter recorded in the nurse's notes and in the doctor's dictated report concerning the procedure. Since there is no standard procedure for this operation, Dr. Varraux established, in discussions with the Respondent, his general procedures which in all cases included the use of cocaine as an anesthetic. Respondent actually assisted in very few of Dr. Varraux procedures. Eighty-five percent of his procedures were done with Ken Rosenau assisting and Mary Ann Hinds assisted in others. However, Respondent was the supervisor of the endoscopy section and if there was a problem, Dr. Varraux would go to her first. Lynn W. Capraun, an instructor of respiratory therapy at Valencia Community College, and an advisor in that area to ORMC, was asked by Mr. Rogers to audit the endoscopy section records for bronchoscopies performed from July, 1982 through January, 1983. His audit was limited to only those on a list of procedures given him by Mr. Rogers and he is not aware of what percentage of the total bronchoscopy load this list consisted of. However, as a part of this audit, he reviewed for each specific case the doctor's clinical resume' and the nurse's notes to see what the doctor called for and what was in fact done. Based on his audit, it appeared that during the period in question, more than 203 ml of cocaine had been ordered by physicians but there was no supporting documentation in the nurse's notes to indicate that the cocaine had been administered even though there was documentation for the use of other drugs. Here, it should be noted that Mr. Capraun is also the partner of Mr. Rogers in a private respiratory therapy business. The records of the pharmacy at ORMC revealed that the last issue of cocaine too the endoscopy section prior to the audit was made in July, 1982. Prior to that time, as far back as 1981, records indicated that the pharmacy had issued 60 ml of cocaine solution every three or four weeks. All issues are reflected as such issues are logged and the name of the individual to whom the drug is issued, who must be licensed, is retained. In addition, pharmacy records reflected no issue of any controlled drug, not only cocaine, to the endoscopy section between late October, 1982 and January 3, 1983. After Respondent was suspended on January 19, 1983, Mr. Holton examined the drug sheets kept in the endoscopy section and the drugs kept on the floor. He found three bottles of cocaine solution, one of which contained 60 ml and the other two contained 40 ml. Analysis of the contents of one bottle reflected the solution at 3.9 percent cocaine which is acceptable. The other two bottles, however, were at a lower strength - one at .5 percent and the other at 1.4 percent cocaine. Though there were three bottles of solution, only two records to support these bottles were found. One was dated May 21, 1982 and the other, June 23, 1982. Cocaine is issued by the pharmacy only upon the presentment of a proof of use sheet which reflects the fact that the previous issue has been used up and it is the practice of the pharmacy, according to Mr. Holton, not to issue new supplies of a controlled substance without a proof of use sheet to show the use of the previous issue. The records of the hospital reflect that the Endoscopy section is a small user of any controlled drug. From the above, an inference can be drawn that cocaine was improperly removed from the Endoscopy section. However, from review of the evidence as a whole, not only that already discussed but that to be discussed as well, it is impossible to determine for certain that there was a loss and if so, who was responsible for it. It certainly cannot be said with any degree of certainty that the Respondent either took it or knew who did. When Mr. Rogers received the letter from Dr. Varraux regarding the use of cocaine in the Endoscopy section of his department, he went to look for the Respondent to discuss the problem with her. He found that she had gone for the day and so he discussed the situation with Mrs. Williams, one of Respondent's assistants, who advised that Respondent had, at times, asked her to substitute xylocaine for cocaine. The following day, he looked into the situation further and after talking with his supervisor, called in Respondent and showed her Dr. Varraux's letter. He says Respondent first indicated she was aware of the situation - then changed her position. She again changed her position, indicating that she was aware of only one incident and that she had discussed with the employees of the section the illegality of the practice advising them not to do it. Mr. Rogers was told by his employers that he could suspend the Respondent if he felt it to be necessary. As a part of his inquiry, he discussed the matter with Mr. Holton and other employees of the department whom he asked to make statements regarding the alleged substitution. His requests were for specifics of the incidents - if they knew of the practice, who had asked them to do it, and things of that nature. When he got the employees' statements back, he reviewed them and took them to the personnel office for advice. Thereafter, he notified Respondent by mail of her termination. Mary Ann Hinds worked at the Endoscopy section as an LPN during the period July, 1982 through September, 1983 assisting physicians, including Dr. Varraux, in bronchoscopy procedures. She contends that at some time during October or November, 1982, Respondent called her into the office and advised that cocaine would no longer be used in bronchoscopy procedures and xylocaine would be substituted. She says she was told to chart the initial 4 percent xylocaine solution but not the 10 percent xylocaine solution she would give to the doctor without telling him of the substitution even though the doctor might ask for cocaine. She says that Ms. Bailey told her this would be done because during a prior procedure when the assistant used xylocaine instead of cocaine, Dr. Varraux did not know the difference and Bailey concluded that they would use the xylocaine instead of cocaine thereafter. Ms. Hinds did not question this because Respondent was the head of the department. Ms. Bailey was, in her opinion, difficult to talk to and as a result of these instructions, she followed this new procedure from the time of the instruction on through January, 1983. During this period, she saw Mr. Rosenau and Mr. Hooper also do the same thing. Although Ms. Hinds was quite definite in her testimony regarding the conversation with Ms. Bailey, she is significantly less sure of her testimony regarding control of drugs on the ward. For example, she cannot recall ever signing any proof of use forms. She contends that the LPNs and technicians did not sign off on the drug book. They would tell the Respondent what was used and she made the entries. When cocaine was to be used, she got it from a bottle in the Respondent's office. Helen Williams also worked under Respondent in the endoscopy section until January, 1983 assisting doctors with bronchoscopy procedures. When she first came to work in this section, she did not know that cocaine was being used. She recalls that in a conversation shortly after she came to work, Respondent told her they were using 4 percent xylocaine solution in place of a cocaine solution because they had done it one time with Dr. Varraux and he did not notice and as a result, they continued to follow this procedure. However, Ms. Williams, though she subsequently heard from Rosenau that substitutions were being made, never saw it done nor did she ever substitute. Though she says she advised Respondent she didn't think this substitution was a good idea, Respondent is supposed to have replied that this is the way it was done. Ms. Williams accepted Ms. Bailey's word when told that there was no cocaine on the unit and that cocaine was not being used even though the drug book at the time showed 27 cc of cocaine solution unused and on the unit. She discussed this with Ms. Bailey and concluded that if her supervisor knew about it, that was sufficient, and she did not report this to anyone else. She also did not report her knowledge of the substitutions being made to anyone else because she did not feel it was her place to do so since Respondent was the section head and knew about it. Ted Hooper, also an endoscopy technician, did bronchoscopies with Dr. Varraux for several years and toward the end, substituted xylocaine for cocaine in these procedures without telling the doctor what he was doing. He had seen Rosenau substitute xylocaine while he was watching procedures to learn how to do them before becoming a technician. When he asked Bailey about this, he says, she responded that it was done, for one reason, because it was cheaper for the patient. She also told him it was all right to do this as it had already been taken care of. She did not tell him, outright, to make the substitution but because she had said it was taken care of, he thought it was permissible. However, he also contends that he observed cocaine being used by Hinds and others in Dr. Varraux' cases after he became a technician in July, 1982. James E. Hardy, in October, 1982, employed as a transporter in the Endoscopy section of ORMC, also assisted in bronchoscopies, working at times with Dr. Varraux and he was aware of the practice of substituting xylocaine for cocaine in these procedures. When he first went to work in the section, he says, he was asked to substitute by Respondent who told him it was being done because it was cheaper for the patient but refused to do so. To his knowledge, however, he does not recall seeing the substitution actually performed. On one bronchoscopy he recalls, which he set up, cocaine was used which he got from Respondent. Mr. Rosenau testified at the March, 1985 hearing. He clearly indicated that xylocaine was substituted for cocaine in the procedures performed by Dr. Varraux and the cocaine they had on hand was rarely taken from the drug locker. He absolutely denies that during all the period of time he was working with Respondent, he ever discussed with her or admitted to her that he had substituted xylocaine for cocaine nor did Respondent ever tell him to do this. In fact, he cannot recall how this practice got started. Here it should be noted that Rosenau, Hardy, and Hooper were all friends of Mr. Rogers and at least Rosenau and Hardy owed their employment at the time to him. Respondent was recognized by Dr. Bone as partially responsible for the growth of the Endoscopy section at ORMC. He recalls her as being an exceptional nurse: reliable, dependable, and proficient - a perfectionist who did an excellent job. He had complete confidence in her ability and in her honesty and integrity. If he asked her to do something, she did it more reliably than others. Because of her perfectionist nature, however, she may have alienated people and turned them away, but he never had any doubts about her nor did he ever have any reports from other doctors that she did not do her job well. He worked with her until she left the hospital. She was a "take charge" person but never exceeded her authority or deviated from prescribed procedures or doctors' orders. This opinion of Respondent is shared by Christina Stephens who worked under Respondent for a period of time. She found the Respondent to be stern, regimented as to order of procedures, and very organized, but she never saw any irregularities by the Respondent in carrying out doctor's orders. As to Mr. Rosenau, however, of whom she also had some knowledge, she found him to be somewhat unprofessional in his patient care and actions and brought this to the attention of the supervisor by written report on several occasions. This was, however, several years prior to the time in issue here and she has not worked with him since 1976 nor does she have any knowledge of his performance since that time. Respondent began work at ORMC after she was a student in the respiratory therapy program there at the request of Mr. Rogers. She started as a pulmonary rehabilitation technician part time. At that time, there were only two employees in the section. When, after a few months, the supervisor left, Respondent took over. Over a period of time, new procedures were introduced including gastroenterology and Respondent was trained in them as she went. She began doing more of the latter than pulmonary rehabilitation even though she remained head of that section. She was then asked to help set up an Endoscopy section and started doing those procedures as well. Rosenau was working on the floor in the respiratory therapy section and was having trouble with his supervisor. As a result he wanted to come to work in the Endoscopy section and Respondent arranged a transfer for him even though he had little experience in endoscopy and none in gastroenterology. When she first started working with gastroenterology, the patient and his medication were brought into the section. When the procedure was finished, the unused medication was sent back with the patient. As the section got bigger however, and more procedures were accomplished, this practice began to hold things up. The physicians requested that medications be kept in the section for their use. Respondent resisted this because she did not feel there were sufficient safeguards available to maintain proper control. Nonetheless, the physicians pushed for it but the change did not happen until Dr. Varraux became insistent that the medications be kept there. He worked through Rogers and Holton to get a narcotics box installed on the section. When this was done Mr. Holton gave two sets of keys to the box to Mr. Rogers who immediately turned one set over to the Respondent and gave one set to Rosenau. When Dr. Varraux decided to use cocaine for anesthesia he discussed it with Rogers and Holton since Respondent did not have the authority to request it. As a result, the pharmacy began dispensing 60 ml bottles of cocaine solution for use in bronchoscopies with a control sheet accompanying it to be kept in the locked portion of the bronchoscopy cart. Again, Respondent and Rosenau both had access to this cart. In fact, Rosenau had access to every key that Respondent had except the one to her desk. According to the Respondent, she had difficulty with Rosenau regarding drugs on several occasions when he would draw narcotics into syringes, a procedure he was neither trained nor authorized to do. In the Spring of 1982, bronchoscopies were done by nurses who would give valium but cocaine was administered by Rosenau only. However, when cocaine was used, Respondent would sign off on the sheets along with others whose names appeared on the form as administers of the drug. In mid-1982 bronchoscopies were transferred to the respiratory therapy section, by then headed by Rosenau, but this did not seem to work out and after a short period, the procedure was returned back to the endoscopy section, with Rosenau still doing them under the overall supervision of Respondent. Respondent contends that she did not train people to do the bronchoscopy procedures. Rosenau had been doing this for months before all of this took place. Ms. Hinds came to work in late July, 1982, and Respondent had no control over bronchoscopies at that point as they were in Rosenau's section. As to Hardy, she characterized him as an errand boy who was never trained to do bronchoscopies and with whom she never discussed them. She did, however, have a discussion with Rosenau on one occasion about cocaine. She relates that on this particular instance, Rosenau advised her in confidence that he had substituted Xylocaine for cocaine by mistake on a bronchoscopy performed by Dr. Varraux and wanted to get it off his chest. He assured her that if she would give him another chance, he would never let it happen again. Here, even though Rosenau had a previous disciplinary record which she had discussed with Rogers, she decided to take no action because she felt it would be fruitless. Rogers had taken no corrective action against Rosenau in the past and she had no reason to believe he would do so now. Rosenau, as was seen above, denies this conversation but no doubt it did occur. Respondent does not know why she was terminated and was shocked by the action. Rogers had mentioned something about cocaine and had given her an opportunity to resign but she refused. She claims to know nothing about the dilution of the cocaine solution. She claims to know nothing of the substitutions of xylocaine for cocaine other than that reported to her by Rosenau. She categorically denies ever telling Hinds, Williams, or anyone else to substitute xylocaine for cocaine. Counsel for Respondent spent considerable time attempting to establish that the charges against her are the result of a plot by Rogers, Rosenau and others at the hospital to remove her from her position. At best, the evidence shows a lack of control within the respiratory therapy section. There does appear to be a decided relationship between Mr. Rogers and Mr. Rosenau but Respondent has failed to establish that this relationship manifested itself in a plan to bring about her unjustified separation. The evidence establishes that xylocaine was substituted for cocaine and there is some substantial evidence to indicate the Respondent had some knowledge or information indicating that this was being done. There is no credible evidence, however, to establish that Respondent herself substituted xylocaine for cocaine or instructed or directed anyone else to do so. At worst hers is a sin of omission rather than commission.

Florida Laws (1) 464.018
# 6
DEPARTMENT OF HEALTH, BOARD OF PHARMACY vs OLA`S PHARMACY, INC., 03-004782PL (2003)
Division of Administrative Hearings, Florida Filed:Miami, Florida Dec. 22, 2003 Number: 03-004782PL Latest Update: Jan. 10, 2025
# 7
DEPARTMENT OF LAW ENFORCEMENT, CRIMINAL JUSTICE STANDARDS AND TRAINING COMMISSION vs. MILTON FRANKLIN, 89-000715 (1989)
Division of Administrative Hearings, Florida Number: 89-000715 Latest Update: Aug. 18, 1989

The Issue Whether Respondent failed to maintain the qualification set forth in Section 943.13(7), Florida Statutes, requiring a law enforcement officer in the State of Florida to have good moral character.

Findings Of Fact On October 8, 1968, the State of Florida, acting through Petitioner, certified Respondent as a law enforcement officer. Certificate number 02-13556 was duly issued to Respondent by Petitioner. Respondent was employed as a police officer by the South Miami Police Department in April, 1988. Respondent was directed by his employer to present himself on April 27, 1988, for an annual physical examination at Mount Sinai Medical Center. Under the policy of the South Miami Police Department, all officers are required to submit to an annual physical examination, which includes an analysis of a urine sample from the officer for the presence of controlled substances. The specific date on which an officer is required by the South Miami Police Department to report for his annual physical is randomly selected. On the morning of April 27, 1988, Respondent reported to Mount Sinai Medical Center to submit to the annual physical examination required by the South Miami Police Department. At approximately 9:45 a.m., he was given a small sterile sample bottle in which he produced a sample of his urine as instructed. Nurse Joyce Hampton, the Mount Sinai employee responsible for the collection of urine samples from police officers undergoing annual physicals, received the urine sample from Respondent and promptly poured the urine sample into another sterile bottle and sealed the bottle with its cap and then with evidence tape. The sealed bottle containing Respondent's urine sample was labeled so as to identify it as Respondent's urine sample and placed in a locked box. On the afternoon of April 27, 1988, the sealed bottle containing Respondent's urine sample was picked up by an employee of Toxicology Testing Service and transported to the facilities of Toxicology Testing Service in Dade County, Florida. Mount Sinai used adequate procedures to ensure that Respondent's urine sample was properly labeled, that the chain of custody was properly maintained, and that the urine sample could not be tampered with without detection. On May 3, 1988, the sealed bottle containing Respondent's urine sample was opened by a laboratory analyst employed by Toxicology Testing Service. Respondent's urine was thereafter analyzed by Toxicology Testing Service. Toxicology Testing Service used adequate procedures to ensure that Respondent's urine sample was properly identified, that the chain of custody was properly maintained, and that the urine sample had not been tampered with. The testing procedures followed by Toxicology Testing Service are widely accepted in the industry. The equipment used by Toxicology Testing Service was in proper working order. A small amount of Respondent's urine sample was introduced into the analyzer equipment used by Toxicology Testing Service to screen the sample for the possible presence of controlled substances. The sample screened positive for cocaine metabolite, a metabolized derivative of cocaine created by the natural processing of cocaine by the human body. A confirmatory analysis of the sample was then conducted utilizing the gas chromatography mass spectrometry method of testing urine samples. This method is over 99% accurate and is the accepted method among toxicologists for identifying drugs and their metabolites. The procedures followed in the taking of Respondent's urine sample and in the subsequent analysis of the urine sample were consistent with the procedures set forth in Rule 11B-27.00225, Florida Administrative Code, which is entitled Controlled Substance Testing Procedures. Respondent's urine contained a metabolite of cocaine, in a concentration of 100 nanograms per milliliter. This result was due to Respondent's use of cocaine. Respondent contends his positive testing for cocaine was caused by his passive exposure to cocaine from the several cups of a type of coca tea that he drank on a daily basis. This contention is inconsistent with the results of the urine analysis and is rejected. Respondent took early retirement with the South Miami Police Department on May 19, 1988, the date the Department's internal affairs investigators had asked Respondent to give a sworn statement as to his use of cocaine.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is: RECOMMENDED that Petitioner, Florida Department of Law Enforcement, Criminal Justice Standards Training Commission, enter a final order which finds that Respondent failed to maintained good moral character and which further revokes the certification of Respondent as a law enforcement officer. DONE AND ENTERED this 18th day of August, 1989, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of August, 1989. APPENDIX TO RECOMMENDED ORDER, CASE NO. 89-0715 The proposed findings of fact submitted on behalf of Petitioner are addressed as follows: Addressed in paragraph 1. Addressed in paragraph 2. Addressed in paragraph 3. Addressed in paragraph 4. Addressed in paragraph 5. 6.-13. Addressed in paragraphs 6 and 7. 14-19. Addressed in paragraphs 8, 9, and 11. The proposed finding of fact submitted by Respondent that the positive testing for cocaine was produced by a coca tea that he drank is addressed by paragraph 11. Respondent's letter filed July 14, 1989, contains no other proposed finding of fact. COPIES FURNISHED: Joseph S. White, Esquire Assistant General Counsel Florida Department of Law Enforcement Post Office Box 1489 Tallahassee, Florida 32302 Milton Franklin 11635 Southwest 136th Terrace Miami, Florida 33176 Jeffrey Long, Director Department of Law Enforcement Criminal Justice Standards Training Commission Post Office Box 1489 Tallahassee, Florida 32302 James T. Moore, Commissioner Department of Law Enforcement Post Office Box 1489 Tallahassee, Florida 32302 Rodney Gaddy, General Counsel Department of Law Enforcement Post Office Box 1489 Tallahassee, Florida 32302

Florida Laws (3) 120.57943.13943.1395 Florida Administrative Code (3) 11B-27.001111B-27.0022511B-27.005
# 8
DEPARTMENT OF HEALTH vs ALTAIRE PHARMACEUTICALS, INC., 09-000326 (2009)
Division of Administrative Hearings, Florida Filed:Miami, Florida Jan. 20, 2009 Number: 09-000326 Latest Update: Jan. 10, 2025
# 9
BOARD OF MEDICAL EXAMINERS vs. CARLOS DE LA FE, 83-003502 (1983)
Division of Administrative Hearings, Florida Number: 83-003502 Latest Update: May 08, 1990

The Issue The issues presented herein are whether or not Respondent's incense to practice medicine should be suspended, revoked or the licensee otherwise disciplined for alleged violation of Chapters 458 and 893, Florida Statutes, as set forth in the Administrative Complaint filed herein signed May 31, 1983.

Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received, stipulations of the parties and the entire record compiled herein, I hereby make the following relevant factual findings. Respondent is a medical doctor and has been issued license number ME 0017825. Respondent's last known address is 2361 N.W. 24 Terrace, Miami, Florida 33172. (Stipulation of the parties) Respondent has been licensed as a medical doctor in Florida since 1971. Respondent studied at Havana University School of Medicine and graduated in 1957. He practiced in Cuba from 1957 through 1966. During that period, he was engaged in a general practice and was also a psychiatrist at Clinica Dependiente. While at Clinica Dependiente, Respondent served as a medical director for the rehabilitation of minors and as medical director for Santa Clinica Psiquiatria. Respondent relocated from Cuba and came to Miami on or about February 15, 1967. Respondent sat for the Federation of State and Medical Boards of the United States during September of 1968, the standardized test for graduates of foreign medical schools. During 1968 and 1969, Respondent was engaged as a psychiatrist at Halifax District Hospital in Daytona Beach, Florida. During 1969, he served a rotating internship at Mount Sinai Hospital for one year. Thereafter, he served rotating internships at Doctors, Victoria, Parkway and one other hospital in the Dade County area until approximately 1974. During his tenure at Halifax Hospital, Respondent treated some parties who were drug addicts. Respondent admits to having treated the patients referred to in the Administrative Complaint filed herein. Additionally, pursuant to Petitioner's Request for Admissions filed herein, Respondent has admitted the allegations set forth in paragraphs 3, 10, 17, 24, 31, 38, 45, 52 and 59 of the Administrative Complaint, to wit: Between the dates of approximately January 5, 1981 and December 15, 1981, Respondent prescribed 360 Dilaudid 2/ (Hydromorphone), a controlled substance, pursuant to Chapter 893, Florida Statutes, for Patrick Golden. Between the dates of approximately March 26, 1981 and January 15, 1982, Respondent prescribed 1425 Dilaudid (Hydromorphone) for Ellen Henderson. Between the dates of approximately March 2, 1981 and November 11, 1982, Respondent prescribed 855 Dilaudid (Hydromorphone) for Ronald Chica. Between the dates of approximately May 12, 1981 and January 9, 1982, Respondent prescribed 132 Dilaudid (Hydromorphone) for James Brannigan. Between the dates of approximately February 19, 1981 and February 2, 1982, Respondent prescribed 965 Dilaudid (Hydromorphone) for Gilbert Fernandez. Between the dates of approximately November 21, 1981 and December 12, 1981, Respondent prescribed 180 Dilaudid (Hydromorphone) for Patsy Gamlin. Between the dates of approximately January 7, 1981 and January 14, 1982, Respondent prescribed 820 Dilaudid (Hydromorphone) for Rudolph Ferguson. Between the dates of approximately February 24, 1981 and February 15, 1982, Respondent prescribed 2220 Dilaudid (Hydromorphone) for Michael Salle. Between the dates of approximately February 24, 1981 and February 15, 1982, Respondent prescribed 2190 Dilaudid (Hydromorphone) for Ronald Weatherington. Dale K. Lindberg, M.D., was tendered and received as an expert in these proceedings in the area of Family Practice, Methadone and Drug Addiction. Dr. Lindberg has been instrumental in establishing a methadone detoxification program at Memorial Hospital in Hollywood, Florida. Methadone is the only legally recognized Schedule II controlled substance used in this country for the treatment of drug addiction. Private practitioners, pursuant to specific federal law, cannot legally administer methadone or any other Schedule II controlled substance for the treatment of drug addition. In order to qualify or be certified to treat drug addicts, application must be made simultaneously with the Federal Food and Drug Administration (to their Methadone Monitor Division), to the Federal Drug Enforcement Agency and to the Federal Department of Mental Health and Drug Abuse. Upon certification with these governmental departments, only then can a physician prescribe methadone to a drug addict to be ingested in oral form, once a day. (21 C.F.R. 291.505) Dr. Lindberg received and reviewed the nine (9) patients' records listed in the Administrative Complaint as well as the prescriptions written for those patients by Respondent. (Petitioner's Exhibit 2-19). Dr. Lindberg, after review, concluded that Respondent inappropriately and excessively prescribed Dilaudid to said patients. Dr. Lindberg opined that Respondent prescribed Dilaudid for those patients for "very little indication" and continued over long periods of time prescribing Dilaudid to those patients. He considered that Respondent was maintaining the patients on Dilaudid in violation of the law. (TR 148, 239). Dr. John Handwerker, M.D., testified as an expert herein on behalf of Petitioner. He has served as the first Chairman of the Department of Family Practice at the University of Florida Family and Community Medicine Programs. He is Chairman of the Family Practice Department of Mercy Hospital in Miami and is Assistant Professor of Pharmacology at the University of Miami. Dr. Handwerker is knowledgeable regarding generally prevailing and accepted standards of family practice in Dade County and was accepted, without challenge, as an expert in the field of Family Practice. Dr. Handwerker reviewed the nine (9) patients' records listed in the Administrative Complaint as well as the prescriptions written for each patient. Based upon Dr. Handwerker's review of those records and prescriptions, Respondent committed gross and repeated malpractice. This opinion stems from Respondent's "inappropriately and excessively prescribing Dilaudid to patient for chronic" while the Physicians Desk Reference clearly stated that Dilaudid should not be prescribed for patients with chronic pain. (Testimony of Dr. Handwerker) SPECIFIC PATIENTS A. Patrick Golden first visited Respondent's office on October 7, 1981. Golden complained of chronic pain arising from trauma suffered while he was involved in an industrial accident. His diagnosis was a compression of the fourth and fifth lumbar disk. He was treated for radiculitis. Respondent prescribed Dilaudid to relieve the pain that patient Golden was suffering from and based on the fact that Golden reportedly had been receiving Dilaudid from a former physician. Respondent conducted an examination of patient Golden and prescribed exercises for him. Respondent did not take x-rays although he states that he observed x-rays which had been taken by Golden's former physician. Respondent prescribed Dilaudid for Golden because it was the only drug which "killed the pain, unlike motrin and metrobromate." Nearing the end of Respondent's treatment of patient Golden, his wife began stealing Mr. Golden's drugs. Respondent referred her to a methadone program and obtained a notarized statement from Mrs. Golden to substantiate the fact that she was diverting drugs intended for her husband. Respondent observed that patient Golden was becoming addicted to Dilaudid nearing the end of his treatment although throughout the major portion of his treatment of patient Golden, he felt that while he was dependent on Dilaudid, he was not felt that while he was dependent on Dilaudid, he was not "addicted." Respondent tried to reduce the amount of Dilaudid that he was prescribing to patient Golden without success. Respondent believed that Dilaudid was medically necessary to treat patient Golden due to the suffering he was undergoing from the chronic pain. (Respondent's testimony and Petitioner's Exhibit 20). B. Ellen Henderson was treated by Respondent during the dates of approximately March, 1981 through January, 1982. Henderson suffered with her lumbar spine. Patient Henderson took motrin tablets since her preteen years. Patient Henderson has been treated at several methadone centers and is believed to have been taking approximately 25-40 Dilaudid four-milligram tablets per day. Upon Respondent's first treatment of patient Henderson, he advised her that she was "killing herself and that she needed to reduce that terrible dosage of Dilaudid." Patient Henderson was "treated for pain in the back and to reduce the amount of Dilaudid." In this regard, Respondent tried to reduce her intake of Dilaudid to approximately 8 Dilaudid four-milligram tablets per day. When Respondent stopped treating patient Henderson, he had reduced the amount of Dilaudid that he was prescribing for her to approximately 8 four- milligram tablets of Dilaudid per day. C. Respondent treated Ronald Chica from approximately March, 1981 through November, 1982. Chica was treated for spondylolysis--a degeneration of the vertebrae. Respondent prescribed Dilaudid for patient Chica because it relieved the pain. Respondent knew that patient Chica was addicted to the drug Dilaudid. D. James Brannigan was treated by Respondent from approximately May of 1981 through January of 1982. Respondent knew that Mr. Brannigan was dependent upon Dilaudid. Despite this knowledge, Respondent continued to prescribe Dilaudid for Mr. Brannigan in an effort to treat Brannigan's addiction with Dilaudid. Respondent was attempting to ease the withdrawal symptoms that patient Brannigan would suffer if he were immediately cut off from his supply of Dilaudid. E. Respondent treated patient Gilbert Fernandez during the dates of approximately February of 1981 through approximately February of 1982. During that period, Mr. Fernandez suffered from compression features of the ribs and the lumbar region. Mr. Fernandez had a physical and psychological dependence on the drug Dilaudid. Respondent treated patient Fernandez by prescribing Dilaudid tablets for him. Patient Fernandez had been treated at methadone centers in the past and presently was receiving methadone treatment while Respondent was treating him. Respondent prescribed Dilaudid to relieve the pain as well as to ease the withdrawal symptoms that patient Fernandez would undergo if he was immediately taken from the administration of Dilaudid. F. Between the dates of approximately February of 1981 through February of 1982, Respondent prescribed approximately 2,190 four-milligram Dilaudid tablets for patient Ronald Wetherington. Patient Wetherington was given approximately 60 tablets every 7 days. Patient Wetherington was addicted to the drug Dilaudid and Respondent ultimately referred him to a methadone center to deal with his withdrawal problems. G. During the period of February, 1981 through February, 1982, Respondent prescribed approximately 2,220 four-milligram Dilaudid tablets for patient Michael Sallee. Patient Sallee suffered from and was treated by Respondent for a compression fracture of the fifth lumbar. Mr. Sallee was a cabinetmaker and did considerable lifting in the performance of his work. Respondent knew that Mr. Sallee was dependent upon Dilaudid and continued to prescribe the narcotic during the term of his treatment. Respondent attempted to treat Mr. Sallee's addiction with Dilaudid. H. During the period of January of 1981 through January of 1982, Respondent treated patient Rudolph Ferguson and, during that period, prescribed approximately 820 four-milligram Dilaudid tablets for him. Patient Ferguson suffered from and was treated for back and rib problems from an auto accident. Respondent knew that patient Ferguson was dependent upon the drug Dilaudid and knew he was addicted to Dilaudid. Despite this knowledge, Respondent continued prescribing the drug Dilaudid to patient Ferguson to reduce the withdrawal symptoms and "to continue to treat the disease." Respondent referred patient Ferguson to a methadone clinic and, in fact, drove him to a nearby clinic for treatment. I. Respondent treated patient Patsy Gamlin during the period of November 21, 1981 through December 12, 1981. During that period, he prescribed 180 tablets or approximately 60 tablets every 10-14. Respondent administered a drug screen during December of 1981 and did not treat patient Gamlin after December. Dilaudid is a narcotic analgesic; its principal therapeutic effect is relief of pain. There is no intrinsic limit to the analgesic effect of Dilaudid; like morphine, adequate doses will relieve even the most severe pain. Clinically however, dosage limitations are imposed by the adverse effect, primarily respiratory, depression, nausea and vomiting which can result from high dosages. (Physicians Desk Reference, page 1038 [1984 Edition]) The Physicians Desk Reference has this to say about drug abuse and dependence: Dilaudid is a schedule II narcotic. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore dilaudid should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when dilaudid is used for a short time for treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, usually assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Prior to prescribing a drug such as Dilaudid, a physician should take a full history from a patient and perform a thorough physical examination. The history should include, inter alia, the patient's chief complaint, with questions from the physician to the patient involving areas of past problems with the nervous system, ears, eyes, lungs, chest, respiratory system, GI tract and urinary tract. The physical examination should involve all body systems, including blood pressure, examination of the head, neck, chest and back regions. If patient complains of low back pain, there should be a physical examination specifically involving the low back area before prescribing the scheduled controlled substance here at issue. The past history is important to determine the duration of the problem, any previous medical treatment, examinations or tests by other physicians regarding the lumbosacral or low back area. A physical examination should be performed designed to elicit indications of neurological evolvement, including straight-leg raise tests, impairment of sensation in the extremities tests and other neurological inquiries. Such a full history and a physical examination is prior to initiating a course of treatment involving treatment of chronic pain due to the existence of a wide assortment of other treatment modalities which might treat the root of the problem, rather than merely being pain symptoms. An examination of the Respondent's records and the prescribing patterns of Dilaudid for the patients involved indicates that Respondent simply made insufficient findings upon which to base the decision to prescribe the drug Dilaudid. By prescribing Dilaudid, without an adequate physical examination, or the gathering of detailed patient medical history, would constitute a failure to conform to the level of care, skill and treatment recognized by reasonably prudent similar physicians under these conditions and circumstances. By continuing to prescribe these drugs, without any involved discussion or consideration of the effect the previous course of treatment had had on the patient, other than simple inquiry by Respondent concerning, as example, how the patient was feeling, 3/ also constitutes inappropriate prescribing of scheduled controlled substances, and demonstrates a failure to conform to the generally accepted an prevailing standards of medical practice in the Dade County community. (Testimony of Dr. Handwerker) Respondent has never been subjected to disciplinary proceedings in the past. His past professional record reveals that he has a sincere concern for his patients. Throughout these investigative proceedings and the final hearing herein, the Respondent was candid, forthright and truthful. His prescribing of the controlled substance Dilaudid was based on his mistaken opinion that it was medically necessary to prescribe Dilaudid for his patients. Throughout these proceedings, it became clear that Respondent had not kept abreast of the proper course of treatment, detection and proper prescribing patterns for scheduled drugs for the patients be treated. To Respondent's credit, he has been studying the proper prescribing of controlled substances since the initiation of the investigation and the administrative proceedings involved herein. Respondent has never "faked" exams and every prescription that he wrote was based on an office visit and an exam, though a very cursory exam. Respondent did not receive any illegal profits from the sale of drugs nor did he divert, or attempt to divert, any drugs for illegal profit. His office fees, which range from $15 to $25 were not based on the amount of the drugs prescribed but, rather, on the patient's ability to pay. Respondent operates a small general practice with his wife serving as his receptionist. He personally completes all prescription forms with his wife/receptionist. Patients receiving treatment from Respondent are free to get their prescriptions filled at any pharmacy of their choice. Respondent was unaware and the evidence does not show that any of his patients had prior criminal records.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, and the entire evidence of record, it is therefore recommended that a Final Order be entered imposing a written reprimand and one year's probation upon the Respondent Carlos de la Fe, and requiring that during the probationary, he enroll and complete, to the satisfaction of the Board of Medical Examiners, a continuing medical education course concerned with the appropriate indications for and prescription of scheduled controlled substances. 4/ RECOMMENDED this 24th day of October, 1984 in Tallahassee, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904)488-9675 FILED with the Clerk of the Division of Administrative Hearings this 25th day of October, 1984.

USC (1) 21 CFR 291.505 Florida Laws (3) 120.57458.331893.05
# 10

Can't find what you're looking for?

Post a free question on our public forum.
Ask a Question
Search for lawyers by practice areas.
Find a Lawyer