Findings Of Fact The Respondent Walter Deryk is a pharmacist licensed in the State of Florida, License No. 12139. On or about July 30, 1980, while in his employment as chief pharmacist at St. Joseph's Hospital in Port Charlotte, Florida, the Respondent took or converted to his own use, without prescription or permission of his employer, the legend drugs described in attachment one to the administrative complaint, and incorporated by reference herein, which were the property of St. Joseph's Hospital. On or about that same date the Respondent packaged the drugs and delivered them to the United Parcel Service in a package marked "souvenirs shells" for shipment to Kenneth J. Moffa in Long Island, New York. Kenneth J. Moffa is a pharmacist licensed in the State of New York. On a number of other occasions prior to July 30, 1980, while in his employment as chief pharmacist at St. Joseph's Hospital and without permission of that employer nor proper prescription, the Respondent similarly converted legend drugs belonging to the hospital to his own use and shipped them to New York. During a routine inspection for proper packaging by the United Parcel Service, it was discovered that the box shipped to New York on July 30, 1980, contained legend drugs which had been taken from St. Joseph's Hospital pharmacy. The Respondent was arrested for theft shortly thereafter and admitted taking the drugs from the pharmacy. Criminal charges were instituted against the Respondent and the Respondent made a motion to suppress the physical evidence based upon allegations of improper search and seizure. The motion was denied in Circuit Court and the Respondent entered a plea of nolo contendere, but reserving the right to appeal the court's ruling on the suppression issue. That appeal is still pending. The Respondent was convicted in Circuit Court for the theft and this administrative prosecution resulted.
Recommendation Having considered the foregoing findings of fact, the evidence in the record and the pleadings and arguments of counsel, it is RECOMMENDED that the license of Walter Deryk authorizing him to practice pharmacy in the State of Florida be REVOKED. DONE AND ENTERED this 6th day of October, 1981, in Tallahassee, Leon County, Florida. 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 6th day of October, 1981. COPIES FURNISHED: William M. Furlow, Esquire Department of Professional Regulation 130 North Monroe St. Tallahassee, Florida 32301 John D. Hooker, Esquire Suite 100, The Legal Center 725 E. Kennedy Boulevard Tampa, Florida 33602
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: At all times material to this proceeding, the Respondent, Howard E. Staats, was licensed as a pharmacist with license number PS 0007704. On July 15, 1985, Dr. Ali A. Zomorodian treated James C. Jowers for thrombose hemorrhoids at the Memorial Medical Center in Jacksonville, Florida and prescribed Proctofoam HC, allowing three (3) refills of the medication. Proctofoam HC is a "medicinal" drug which is commonly known as a "legend" or "prescription" drug which can only be dispensed by prescription. On July 15, 1985, James Jowers presented the prescription for Proctofoam HC issued by Dr. Zomorodian to the Respondent for filling at Scottie's Discount Drug Store, 41 Arlington Road South, Jacksonville, Florida. During the course of filling the prescription on July 15, 1985, the Respondent discussed genital cancer with Jowers and showed Jowers pictures of the genital area. There was insufficient evidence to show that Respondent asked Jowers to come behind the prescription counter that day on the pretense of checking Jowers' hemorrhoids, and then pulling down Jowers' shorts and touching Jowers' penis and testicles. After Respondent had filled Jowers' prescription for Proctofoam HC on July 15, 1985, Jowers decided that the price was too high and asked that Respondent return his prescription. Respondent returned the prescription to Jowers and Jowers had it filled at the Mayport Naval Station pharmacy on July 16, 1985. While Respondent had the prescription in his possession on July 15, 1985, and before returning it to Jowers, Respondent copied certain information from the prescription and gave the prescription a number (83116) on Respondent's prescription log. This information was placed on file at Scottie's. Based on information furnished by Jowers concerning Respondent's behavior on July 15, 1985, John Danson, Investigator for Petitioner and detectives from the Duval County Sheriff's Office asked Jowers to return to Scottie's and make contact with the Respondent on the pretense of needing the prescription for Proctofoam HC filled. On July 29, 1985, Jowers returned to Scottie's where Respondent was on duty and told Respondent that he had lost the prescription for Proctofoam HC but that he needed it filled. Using the information that he had copied from the original prescription on July 15, 1985, Respondent filled the prescription for Proctofoam HC and gave the medication to Jowers. Jowers upon leaving Scottie's gave the medication to Danson and the detectives from the Duval County Sheriff's Office. There was insufficient evidence to show that Respondent knew on July 29, 1985 that the prescription had been filled at the Mayport Naval Station pharmacy or that the prescription was on file at the Mayport Naval Station pharmacy. The medication given to Danson and the detectives contained the same prescription number (83116) that Respondent had given the prescription when presented to him on July 15, 1985. There was insufficient evidence to show that Respondent asked Jowers into his office and pulled down Jowers' pants and touched Jowers' penis or testicles on July 29, 1985. At all times relevant to this proceeding, the original prescription for Proctofoam HC used by Dr. Zomorodian to Jowers on July 15, 1985 was on file at the Mayport Naval Station pharmacy. The Mayport Naval Station pharmacy did not transfer the prescription for Proctofoam HC issued by Dr. Zomorodian to Jowers on July 15, 1985. Neither Dr. Zomorodian nor his staff "called-in" the prescription for Proctofoam HC given to Jowers by Dr. Zomorodian on July 15, 1985 to Scottie's or the Respondent. The Respondent did not call Dr. Zomorodian or his staff for authorization to dispense Proctofoam HC to Jowers under the prescription issued by Dr. Zomorodian to Jowers on July 15, 1985. Respondent prepared and maintains in his files a written record of the information copied from the original prescription presented to him by Jowers issued by Dr. Zomorodian for Poctofoam HC on July 15, 1985. In addition to the number (83116) being listed in the Scottie's prescription log, it is also listed on the above-referenced record. Respondent's dispensing of the Proctofoam HC to Jowers on July 29, 1985 under the circumstances of this cause was done in good faith. Although there was conflicting expert testimony, Respondent's dispensing of the Proctofoam HC to Jowers on July 29, 1985 under the circumstances of this cause was done in the course of professional practice of pharmacy.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses, it is, therefore RECOMMENDED that the Amended Administrative Complaint be DISMISSED. Respectfully submitted and entered this 12th day of November, 1987, in Tallahassee, Leon County, Florida. WILLIAM R. CAVE 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 12th day of November, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-0287 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the Petitioner in this case. Rulings on Proposed Findings of Fact Submitted by the Petitioner Adopted in Finding of Fact 1. Adopted in Finding of Fact 2. Adopted in Finding of Fact 3. Adopted in Findings of Fact 4 and 6. Adopted in Finding of Fact 6. Adopted in Finding of Fact 8. Adopted in Findings of Fact 8 and 15 but clarified. Adopted in Finding of Fact 8. Adopted in Findings of Fact 6 and 12 but clarified. Rejected as not supported by substantial competent evidence, as being hearsay and as not being material or relevant. 11-13. Adopted in Findings of Fact 13 and 14 but clarified. 14.-15. Although Dr. Zaenger's background and the fact that she testified as an expert witness on the standards of practice in pharmacy are important to determine the weight given her testimony, these findings are not necessary and add nothing to the finding of fact in this order. Rejected as being a conclusions of law rather than a Finding of Fact. Rejected as not being material or relevant since it is not a finding of fact but only a statement of a hypothetical situation. Rejected as not supported by substantial competent evidence. 19.-23. Rejected as not being material or relevant. Rulings on Proposed Findings of Fact Submitted by the Respondent 1. Adopted in Finding of Fact 1. 2-3. Adopted in Finding of Fact 4. 4. Adopted in Finding of Fact 13 but clarified. 5.-6. Adopted in Findings of Fact 13 and 14 but clarified. 7.-8. Paragraph 7 and the first sentence of paragraph 8 rejected as a restatement of the testimony and not a finding of fact. The balance of paragraph 8 is adopted in Findings of Fact 6, 7 and 8 but clarified. Adopted in Finding of Fact 6. Adopted in Finding of Fact 7. Adopted in Finding of Fact 5 but clarified. 12.-14. Adopted in Finding of Fact 8. Adopted in Finding of Fact 6. Rejected as not being material or relevant. 17.-19. Adopted in Finding of Fact 8. Adopted in Finding of Fact 12. Adopted in Finding of Fact 14 but clarified. Adopted in Finding of Fact 3. Adopted in Finding of Fact 8. 24.-27. The first two (2) sentences of paragraph 25 are adopted in Findings of Fact 3 and 10. The balance of paragraphs 24-27 are rejected as being a restatement of the testimony and not a finding of fact. COPIES FURNISHED: Robert D. Newell, Jr., Esquire Newell & Stahl, P.A. 102 S. Monroe St. Tallahassee, Florida 32301 Robert Palmer, Esquire Michael Ed wards, Esquire Suite 305, 24 N. Market St. Jacksonville, Florida 32202 Tom Gallagher, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Rod Presnell, Executive Director Board of Pharmacy Department of Professional Regulation 130 N. Monroe St. Tallahassee, Florida 32399-0750
The Issue The issue for consideration in this case is whether Respondent's license as a physician in Florida should be disciplined because of the matters alleged in the Administrative Complaint filed herein.
Findings Of Fact At all times pertinent to the issues herein, the Petitioner, Board of Medicine, has been the state agency responsible for the licensing of physicians and the regulation of the medical profession in Florida. Respondent was a licensed physician in Florida under license number ME 0039846. On September 23, 1988, Respondent saw Patient #1, a 55 year old female, who presented with a primary complaint of chronic pain in the neck and low back resulting from an automobile accident. The patient history taken by the Respondent revealed a head injury, a back injury and a whiplash injury, all within the previous five years. The patient also had a history of unstable blood pressure, especially in times of stress, and a history of alcohol abuse which had been in remission for the past two years. Respondent examined the patient and found she was suffering from depression but evidenced no suicidal ideations or indications of psychosis. Respondent diagnosed a major depressive reaction and myofacial syndrome of the neck and low back. Dr. Morales treated this patient from September 23, 1988 to February 1, 1990, prescribing various antidepressants and anti-anxiety medications including Limbitrol, Prozac, Valium, Halcion and Tranxene for her. He also prescribed various opiates including Percodan and Percocet. Respondent claims he made a copy of each prescription he wrote for the patient medical records of each patient so that he could keep track of the number of pills he prescribed for that patient. He claims that the quantity of a prescribed medication was kept in a separate area of the patient's chart and not with the clinical notes. Though Respondent claims this procedure was a common office practice and done consistently in every patient's chart, the evidence indicates otherwise. His method of recording medication in the clinical record was inconsistent. At some places in the record he would indicate the exact number of a specific pill prescribed. At other places in the record, he would not. Examples of this practice, as seen from the medical records of Patient #1 available, shows the following entries: October 20, 1988, Rx for Valium for patient #1 but no indication of the amount prescribed is found in the records. March 2, 1989, Rx for Percodan QID (4 times a day), but no indication in records of the amount prescribed. July 8, 1989 Rx for Percodan - 60 tabs. August 2, 1989 Respondent notes to continue with Percoset, but no notation in records as to amount. September 7, 1989 Rx for Percocet but records do not reflect amount prescribed. November 15, 1989 Rx for 60 Percocet. December 6, 1989 Rx for 30 Percocet pills. While Patient #1 was under Respondent's care, she was admitted to the hospital twice. On September 18, 1989 she was admitted to Largo Medical Center for narcotics addiction and was discharged on September 28, 1989. On September 18, 1989, while the patient was in the hospital, Dr. Farullah, a staff physician, called Respondent to discuss the patient with him. This conversation, including the Respondent's name, is itemized in the hospital records for this patient. It is appropriate practice protocol upon the admission of a patient to the hospital for the admitting physician to notify the patient's attending physician about the patient's diagnoses and condition. It would appear this was done here by Dr. Farullah. Nonetheless, Respondent claims he did not know the patient was hospitalized, contending he did not recall the conversation, and noting that the information regarding hospitalization might not have been included in it. Respondent claims he never heard of Dr. Farulla until a subsequent visit from the patient in his office on October 24, 1989. After the patient's discharge from the hospital, she came to Respondent's office for a 30 minute visit on October 4, 1989. Though this visit occurred only 6 days after her discharge from the hospital, Respondent claims the subject of her hospitalization was not discussed. Two days later, on October 6, 1989, the patient returned to Respondent's office for another 30 minute visit and again, the subject of her hospitalization did not come up. This patient was readmitted to the hospital on October 10, 1989 with a diagnosis of, among other things, drug dependency. She was discharged on October 20, 1989, but, again, Respondent claims he did not know of her hospitalization. He saw her on October 24, 1989 for another 30 minute visit during which, he claims, the subject of her hospitalization did not come up. This appears to be a conflict with his previous testimony , noted in Paragraph 8, supra, wherein he stated he never heard of Dr. Farullah until he met with the patient in his office on October 24, 1989. On April 10, 1990, in the course of filing a disability claim with the Department of Health and Rehabilitative Services, (DHRS), the patient signed a medical release form. Thereafter, HRS requested the patient's records from the Respondent, but they were not forthcoming. A second request was transmitted to the Respondent who replied that the records requested had been copied but not dispatched because no release form accompanied the request. Respondent indicated that upon receipt of the release form, the records would be forwarded, and on June 4, 1990, they were, in fact, sent by the Respondent. This was approximately 17 months before the burglary of Respondent's office to be discussed, infra. Respondent claims it was his policy, however, in responding to requests for information to the Social Security Administration, (disability claims are paid by Social Security), to provide only clinical notes, initial evaluation, and a medical summary update. Other records, including prescription records, are not sent. Respondent's office was burglarized on November 30, 1991 by one of his former employees. According to Respondent, all the medical records he had were taken during the break-in. Though they were ultimately returned, he claims they were incomplete when returned. However, comparison done by the Department's investigator, of the medical records of Patient #1 which were sent to HRS before the burglary with those taken from Respondent's office after the burglary, indicated they were the same, except for some duplicates. Nonetheless, Respondent claims that some of the records pertaining to Patient #1, including prescription records, were not recovered. This could explain the absence of prescription records in both sets of records, but that is not found to be the case here, however. According to the Board's expert, Dr. Boorstin, a Board Certified Psychiatrist who specializes in addiction psychiatry and opiastic medicine, the benzodiazepins prescribed for Patient #1 by the Respondent, were inappropriate because of her known alcoholism, and he failed to adequately monitor her for possible addiction or dependence. Even though her condition had been in remission for two years, Dr. Boorstin concluded it was below standard practice to prescribe those drugs to this patient. Dr. Boorstin also concluded that Respondent failed to keep adequate written medical records for this patient and did not justify the less than conservative prescription of anti-anxiety and pain medications to a known alcoholic. A physician must keep track of the drugs being used by a patient to be sure no abuse trends exist. The Respondent should have detailed with exactitude in his records the number of each specific medication. From September 30, 1988 to February 1, 1990, a period of 16 months, he prescribed various opiate-based pain killers to Patient #1, including Tylenol #3, Codeine, Percodan and Percocet. His prescription of the latter two, in Dr. Boorstin's opinion, fell below the appropriate standard of care. The patient's hospital records indicate she was suffering from drug addiction, and if, as the Department claims, Respondent knew of her hospitalizations and the reason therefor, his prescription of liberal amounts of opiate based drugs was inappropriate. The evidence shows the patient was admitted to the hospital on two occasions, both times for, among other problems, drug addiction. Less than one month after her second discharge, Respondent prescribed Percocet for this patient for pain relief at a rate of two tables every six hours. According to Dr. Boorstin, the usual adult dosage is one tablet every six hours. This is outlined in the Physician's Desk Reference, (PDR), a compendium of drugs and medications with manufacturer's recommendations for dosage. Though authoritative in nature, the PDR is not mandatory in application, and physicians often use it as a guide only, modifying strength and dosage as is felt appropriate for the circumstance. On at least one occasion, Respondent's medical records for this patient show he prescribed Percocet but not the amount prescribed. This is below standard. The same is true for the noted prescription for Percodan. Both Percodan and Percocet are Schedule II drugs. A notation in the records for a prescription for Valium also reveals no indication was given as to the amount prescribed. Again, this is below standard. Dr. Boorstin's opinion is contradicted by that of Dr. Wen-Hsien Wu, the Director of the Pain Management Center at the Schools of Dentistry and Medicine of New Jersey, the New Jersey Medical School, who testified by deposition for the Respondent. Dr. Wu claims he has prescribed medications in amounts and dosages far in excess of those prescribed by Respondent and for a much longer period of time. Wu is Board certified in anesthesiology and has published numerous articles on pain management. Dr. Wu contends there is no contraindication for the use of narcotic therapy in Patient #1's alcoholism. The use of narcotics is appropriate if the patient can return to function with careful monitoring. Here, it would appear that Patient #1 was monitored through her frequent visits to the Respondent's office. It is impossible to tell from the Respondent's patient records just how much medication he prescribed for his patient. Because of the failure to indicate the number of pills of each type Respondent was prescribing, it is impossible to form a conclusion as to whether the amount prescribed was appropriate or excessive. Notwithstanding Respondent's claim in his Proposed Findings of Fact that "...there is no indication of drug abuse in the prescribed drug area", the medical records show that on each admission of Patient #1, a diagnosis of drug addiction was made. To be sure, these records do not reflect the drug to which the addiction relates.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that a Final Order be entered herein finding Respondent guilty of all allegations except prescribing in inappropriate amounts. It is also recommended that Respondent be ordered to pay an administrative fine of $3,500 within 90 days of the date of the Final Order herein, be reprimanded, and within one year of the date of the Final Order herein, attend continuing medical education courses at the University of South Florida Medical School in appropriate medical record keeping and in the prescribing of abusable drugs. RECOMMENDED this 12th day of June, 1995, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 12th day of June, 1995. APPENDIX TO RECOMMENDED ORDER The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: Accepted and incorporated herein. - 5. Accepted and incorporated herein. 6. - 15. Accepted and incorporated herein. 16. - 19. Accepted and incorporated herein. & 21. Accepted as a representation by Respondent. Accepted as Respondent's position but not accepted as fact. Accepted and incorporated herein. Accepted. - 27. Accepted and incorporated herein. Rejected as unproven. & 30. Accepted but repetitive of other evidence previously admitted. 31. & 32. Accepted and incorporated herein. - 38. Not appropriate Findings of Fact but merely recitations of the contents of records. Accepted and incorporated herein. - 42. Restatement of witness testimony. FOR THE RESPONDENT: Accepted and incorporated herein. - 5. Accepted and incorporated herein. 6. & 7. Accepted as testimony of Respondent, but not as probative of any issue. 8. - 11. Accepted and incorporated herein 12. & 13. Accepted. 14. - 16. Accepted and incorporated herein. 17. Accepted. 18. & 19. Accepted. 20. Accepted. 21. Accepted. 22. - 24. Accepted. 25. - 29. Accepted and incorporated herein. 30. & 31. Accepted. 32. Accepted. & 34. Accepted as opinions of the witness, but not as the ultimate fact. Accepted as to admissions but rejected as to Respondent not being advised. Accepted and incorporated herein. COPIES FURNISHED: Steven A, Rothenberg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33617 Grover C. Freeman, Esquire Freeman, Hunter & Malloy 201 E. Kennedy Boulevard Suite 1950 Tampa, Florida 33602 Dr. Marm Harris Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0770 Assistant Director Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue The issue is whether Billy H. Davis, on two occasions, sold to undercover detectives of the Miami Police Department the medicinal drug Ampicillin without prescriptions in contravention of Section 465.015(2)(c), Florida Statutes (1985), and is therefore subject to discipline pursuant to Section 465.016(1)(e), Florida Statutes (1985)?
Findings Of Fact Respondent, Billy H. Davis ("Mr. Davis"), at all times relevant herein, has been licensed as a pharmacist in the State of Florida, and has been issued license number 0010622. During the period at issue here, Mr. Davis was prescription manager for Service Drugs, Inc. located at 1304 N.W. 3rd Avenue, Miami, Florida 33136 (Exhibits 1 and 2). On March 27, 1985 Detective Carolyn Clarke of the Miami Police Department purchased thirteen red and gray capsules from Mr. Davis for $8.00 (T. 50, 54). She did not present a prescription during the transaction or represent that she had authorization from a physician to obtain any drugs for which a prescription is required (Tr. 52-3). In March of 1985 Officer Jesse J. Williams purchased twelve red and green capsules from Mr. Davis for $8.00 (Tr. 58- 61). He did not present a prescription or indicate that he had authorization from a physician to receive prescription medication during the transaction (Tr. 60). Upon analysis at the Metro Dade Police Department Crime Laboratory, the capsules purchased by Detectives Clarke and Williams proved to be Ampicillin (Tr. 63-77, Department Exhibits 7 and 8). Ampicillin is a prescription or medicinal drug in the United States (Tr. 96). Mr. Davis has sold or dispensed drugs as defined in Section 465.003(7), Florida Statutes (1985) without first being furnished with a prescription. When the drugs were sold, Mr. Davis had been told by the purchasers that they needed medication either for gonorrhea (Tr. 50) or for an unspecified venereal disease (Tr. 59). Oral antibiotics are not the appropriate treatment for drug-resistant strains of gonorrhea, such as penicillinase- producing neisseria gonorrhea ("PPNG") (Tr. 87). There has recently been a large outbreak of PPNG in Florida, and specifically Dade County and Miami (Tr. 89), with a large portion of the disease occurring in the black community in the Liberty City and Overtown areas (Tr. 90). Self-administration of antibiotics has played a role in the propagation of PPNG, because when there is a drug-resistant strain of venereal disease in a community and patients take antibiotics not appropriate to treat their condition, patients believe that they are getting better when they are still infectious (Tr. 93-94). This may cause those patients, if women, to develop pelvic inflammatory disease which can lead to infertility and occasionally users can develop an infection of the heart valves known as bacterial endocarditis (Tr. 94-95). It is not possible for patients to tell from symptoms or by mere physical examination whether they have been- infected with a drug-resistant strain of PPNG: a patient must have a culture done by a physician to make this determination (Tr. 96).
Recommendation Based on the foregoing, it is recommended that a final order be entered finding Mr. Davis guilty of violating Sections 465.015(2)(c) and 465.016(1)(e), Florida Statutes (1985). In view of the well-intentioned nature of Mr. Davis' actions, the apparent absence of any profit motive, but keeping in mind the potential public health hazard involved in dispensing of medicinal drugs for the relief of venereal disease without prescription, it is recommended that pursuant to Section 465.016(2)(b), Florida Statutes, his license to practice pharmacy be suspended for a period of thirty days; pursuant to Section 465.016(2)(c), Florida Statutes, that he be fined a total of $250.00; and pursuant to Section 465.016(2)(e), Florida Statutes, within one year he be required to attend continuing education courses pertaining or relating to the appropriate use of medicinal drugs in the treatment of venereal disease. DONE AND ORDERED this 17th day of June 1986 in Tallahassee, Leon County, Florida. WILLIAM R. DORSEY,JR., Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of June 1986. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Billy H. Davis 1304 N.W. Third Avenue Miami, Florida 33136 Mr. Rod Presnell Executive Director Board of Pharmacy Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Salvatore A. Carpino, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER =================================================================
Findings Of Fact Respondent Jose Raul Suarez has been licensed to practice medicine in the State of Florida since January 12, 1961. He conducts his practice at the Flagler Medical Clinic, 965 West Flagler Street, Miami, Florida. (Testimony of Manresa, Petitioner's Exhibit 1) On August 27, 1979, one Ronald Gudger was arrested by Miami police for possession of a stolen credit card. During the pendency of the criminal proceeding, Gudger informed police officials that Respondent had issued false prescriptions for drugs to himself and to others. On September 10, 1979, Gudger was released and placed in a pretrial intervention program. Subsequent to his release, Gudger told city detectives further details concerning his prior relationship with Respondent, including the fact that Respondent had previously provided him with written prescriptions for Preludin, Placidyl, and Percodan on various occasions in 1979. He also indicated to the officers that Respondent was desirous of obtaining a Betamax video recorder. Gudger had been introduced to Respondent by an individual named "Pete." During the course of some ten to fifteen visits to Respondent, Gudger never received a physical examination or informed Respondent that he had a weight problem or any other medical reason for needing the drugs. However, Respondent had asked him questions once for his records. On only one occasion did he pay Respondent a $10.00 office visit fee. On one occasion, he had promised to give Respondent a "stereo" in exchange for prescriptions for drugs. Although he obtained the prescriptions from Respondent, he was not able to get the stereo. (Testimony of Manresa, Lopez, Gudger (Deposition-Petitioner's Exhibit 7) Rabin, Petitioner's Exhibit 6) Pursuant to an arrangement with Miami narcotics detectives Luis M. Lopez and George Manresa, Gudger became a paid confidential informant for the police department. On September 12, 1979, Lopez and Gudger went to Respondent's office planning to offer Respondent a Betamax in exchange for drug prescriptions. The officers had obtained a Betamax from county sources and it was in the trunk of an unmarked police car parked in a lot in back of Respondent's office. At the time, Manresa conducted surveillance of the parking lot from a van in which he also monitored communication equipment designed to record any conversations in Respondent's office from a transmitter which had been hidden on the person of Lopez. Another police officer had camera equipment. At about 1:00 p.m., Lopez and Gudger entered Respondent's office. Gudger informed the receptionist that they had a Betamax that the Doctor wanted which had been stolen the previous night. In approximately an hour or an hour and a half, when all the patients had left the office, the receptionist told Gudger he could see Respondent. Gudger told Respondent that he had a Betamax waiting for him in return for $100.00 and some prescriptions. Respondent stated that he was short of cash. Gudger informed Respondent that "Louie" was in the outer office and was a friend of his. Respondent asked "Is he cool?" and Gudger said "Yes." Gudger brought Lopez into the office and introduced him to Respondent as the "guy with the Betamax." Lopez told Respondent he had the Betamax , which was "hot," in the trunk of his automobile which was parked behind the office. Respondent stated "It's no problem." They told Respondent that they would take prescriptions for the machine and Respondent asked how they wanted to do it. Lopez gave Respondent list of several names and addresses and told him that he had a brother named Luis Lopez. Lopez identified himself with a false identification card in the name of Luis Trigo. Respondent then proceeded to write six prescriptions for Placidyl 750 mg and Preludin 75 mg in the amounts of 30 each. Two prescriptions were in the name of Luis Lopez, two in the name of Lazaro Luis Trigo, one in the name of Ronald Gudger, and another in the name of Rhonda Gudger, his wife. Lopez asked Respondent to write one prescription for a different date than September 12 and Respondent dated one of the Trigo prescriptions for September 13. While writing the prescriptions, Lopez remarked to Gudger that he was really going to get "high" that night with the pills, and Respondent merely smiled when hearing this statement. Respondent told them that when filling the prescriptions, they should dress neatly and comb their hair so that they would not call attention to themselves. Be also told them not to go to the Golden Pharmacy in North Miami because the police had been checking it and it was "hot." Respondent told Lopez that he would fill out a patient card on him for his records, but did not do so at that time. Lopez told Respondent that he did not want to have a physical examination and Respondent replied that he didn't need one. He told the men to put the prescriptions in their pocket as they left the office so that they would not be noticeable, and said that he would meet them in back for the Betamax. Gudger and Lopez then left the office and went to the parking lot. Respondent followed soon thereafter. Lopez drove his automobile so its trunk was near the trunk of Respondent's car . He opened the trunk and showed the Betamax to Respondent and asked him if that was what he wanted. Respondent said it was perfect because it was a two-hour cassette type and told him to put it in the trunk of his automobile. At that time, the other police personnel in the vicinity came to the scene and arrested Respondent who was thereafter charged with possession and dealing in stolen property and sale of controlled substances. Respondent was later tried on the criminal charges and found not guilty by jury verdict. Patient records obtained from Respondent during the course of discovery in that proceeding reflected both Ronald Gudger and Rhonda Gudger as patients who both suffered from depression and insomnia. In addition, the records indicated that Rhonda Gudger desired to lose weight. Ronald Gudger's card reflected that he had sought treatment on four occasions from May to August 1979, at which time Preludin and Valium had been prescribed, and that on an additional visit he had been issued a refill of Preludin since he had lost his prescription. (Testimony of Manresa, Rabin, Lopez, Igoe (deposition), Gudger (Petitioner's Exhibit 7), Petitioner's Exhibits 2-6, 8) Placidyl is a trade name for Etchlorvynol, a Schedule IV controlled substance under Chapter 893, Florida Statutes. Preludin is the trade name for Phenmetrazine, a Schedule II controlled substance under Chapter 893. Placidyl depresses the central nervous system and is customarily prescribed for insomnia. Preludin is used for appetite suppression, anorexia, and narcolepsy. It is excitatory and produces adrenaline-like effects. Both drugs can be used safely if properly administered after a thorough medical history and physical evaluation has been made by a physician, but should never be prescribed without interviewing the patient and arriving at an informed diagnosis of his condition. In the opinion of an expert medical authority, it would be an unacceptable medical practice to prescribe such drugs to persons whom a physician had never seen. In the vernacular of drug abusers, Placidyl is termed a "downer" and Preludin an "upper." (Testimony of Palmer, Stonis) Respondent testified at the hearing substantially as follows: Ronald and Rhonda Gudger had been his patients whom he had treated for legitimate complaints in 1979. He had prescribed Preludin to Ronald Gudger for conditions of depression, insomnia and obesity, to serve as an anti-depressant and "mood elevator." He had seen Rhonda on June 8, 1979, and prescribed Preludin for her obesity. He saw Gudger on September 12, 1979, at which time Gudger requested that he be given a refill prescription of Preludin and also Placidyl, claiming it was good for his sleep. He also asked Respondent to refill his wife's prescription because she, was doing well on the medication. Respondent claimed that he wrote both prescriptions and told Gudger that he owed $10.00 from his last visit and $10.00 for the present visit, at which point Gudger stated that he had no money but would sell Respondent a Betamax. Respondent then informed Gudger that he did not want anything stolen and Gudger told him that it was "cool" and that he needed money. Respondent stated that he would have to see it. Gudger asked him to see his friend and thereafter brought Lopez into the office. Lopez asked for Preludin stating that he had used it before as a mood elevator. Respondent asked Lopez questions concerning his medical history and was going to perform a physical examination, but Lopez objected stating that he did not need one. Respondent then wrote the prescriptions for Lopez, at which time Lopez told him that he had a 29 year old brother who also took the same medicine and asked for prescriptions for him. Respondent wrote the prescriptions for the brother because he had patients waiting and Lopez had told him the brother was in good health and "strong as an ox." Respondent then went to the parking lot behind his office to obtain a prescription pad and also to see the Betamax which he had agreed to purchase from Gudger if it worked properly and they could agree on a price. He denied that Lopez had told him that the Betamax was "hot." Respondent issued the prescription for Gudger's wife because he trusted him when he stated that his wife had done well on the drug and that she needed a refill of the prescription. He had issued the prescriptions to Lopez because he had said he was in perfect health and just felt "down" and had difficulty sleeping at night. (Testimony of Respondent) Two local physicians and a nursing supervisor testified at the hearing as to their observations that Respondent provided his patients with excellent care. A number of letters were received in evidence from fellow physicians in Miami attesting to Respondent's good reputation as an ethical and professionally capable physician in the community. Also, Respondent's work with the Armed Forces Examining and Entrance Station in Miami was praised in a letter from the station's commanding officer. A nursing administrator for Multicare, Inc. in Miami also provided a letter concerning Respondent's concern for patients' needs in the Medicare program and his efforts to prevent mismanagement of Medicare funds. A high school principal wrote a letter concerning Respondent's treatment of his family and his services to schools and other community activities in the Miami area. (Testimony of Serratta-Noges, Lameles, Cruz, supplemented by Respondent's Exhibit 1)
Recommendation That the State Board of Medical Examiners issue a Final Order suspending the license of Respondent Jose Raul Suarez to practice medicine for a period of one year, pursuant to subsection 458.331(1)(q) and (2), Florida Statutes. DONE and ENTERED this 2nd day of September, 1980, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings 101 Collins Building Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of September, 1980. COPIES FURNISHED: Kenneth G. Oertel, Esquire Acting General Counsel Department of Professional Regulation 2009 Apalachee Parkway Tallahassee, Florida 32301 Julian Mark, Esquire Suite 500 - Security Trust Bldg. 700 Brickell Avenue Miami, Florida 33131
Findings Of Fact At all times material hereto Respondent has been licensed as a pharmacist having been issued license number 0015784. Respondent's license was previously suspended for a period of five (5) years by Final Order of the Florida Board of Pharmacy on June 15, 1984 in Case Number 0036893. In that prior case Respondent admitted to self medicating herself with controlled substances in violation of Section 465.016(1)(d)2, Florida Statutes. Respondent's license is therefore currently under suspension and has been suspended since June 15, 1984. Respondent was hospitalized at Shands Teaching Hospital in June, 1984 by George W. Sypert, M.D., for back and chest pains resulting from an automobile accident in May, 1983. This was Respondent's second hospitalization for treatment resulting from the accident. While hospitalized Dr. Sypert performed surgery on Respondent who was also attended by J. Marc Simard, M.D., a resident at the time. It was Dr. Simard who prepared the discharge summary on Respondent on June 19, 1984 and also wrote a discharge prescription for 10 Percodan which were to be taken one every six hours for severe pain remaining from the surgery which Dr. Sypert had performed. Both Respondent and her husband, George W. Bowen, were under the belief that Respondent would be "adequately medicated" for pain after her operation and upon her discharge. Mr. Bowen was formerly a licensed pharmacist in Florida, but his license has been revoked due to violations involving controlled substances. Mr. Bowen was extremely frustrated and concerned about the pain his wife was suffering and did not feel that 10 Percodan would be sufficient for her discharge. The Percodan prescription was given to Mr. Bowen who admitted during his testimony that he altered the prescription by adding a zero so that the prescription was then for 100 Percodan. Respondent never saw the prescription before or after it was altered, and her husband did not tell her what he had done. Mr. Bowen took this action out of concern for his wife and the pain she was suffering, and he did not take any of the Percodan himself. He had attempted to contact Dr. Sypert to request an increase in the prescription when he saw that Dr. Simard had written it for only 10 Percodan, but he was unsuccessful. Mr. Bowen presented the altered prescription at Eckerd's Drugs on June 20, 1984 and Russell Blaser, a licensed pharmacist, filled the prescription with 100 Percodan, which was paid for by Mr. Bowen and given to Mr. Bowen. Respondent was with her husband when he filled the prescription, but was almost immobile, having just been discharged. Blaser called Dr. Simard after he had filled the prescription to advise Dr. Simard that, due to Respondent's previous drug dependency, he felt that any further prescriptions should be for a lesser amount. It was at this time that Dr. Simard said the prescription he had written was for only 10 Percodan, not 100. Respondent was arrested on or about June 22, 1984, for obtaining a controlled substance by fraud. Following the arrest she learned for the first time that her husband had altered the prescription, and she thereupon destroyed the remaining Percodan.
Recommendation Based upon the foregoing, it is recommended that the Board of Pharmacy issue a Final Order dismissing these charges against Respondent. DONE and ENTERED this 5th day of November, 1985, at Tallahassee, Florida. DONALD D. CONN, 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 5th day of November, 1985.' APPENDIX Adopted in Finding of Fact 1. Rejected in Findings of Fact 3 and 4. Adopted in Findings of Fact 2 and 6. Rejected in Findings of Fact 3, 4 and 7. Rejected as a conclusion of law which is not based on evidence in the record. COPIES FURNISHED: Rod Presnell, Executive Director Board of Pharmacy Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Deborah S. Bowen 1033 N.E. 8th Avenue Gainesville, Florida 32601 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Salvatore A. Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether Petitioner should be granted a Retail Pharmacy Drug Wholesale Distribution Permit, pursuant to Subsection 499.01(2)(f), Florida Statutes (2009).1
Findings Of Fact Background Petitioner holds Florida Community Pharmacy License No. PH23699 (the “pharmacy license”), pursuant to Chapter 499, Florida Statutes. The establishment is located at 1507 Park Center Drive, Suite 1L, Orlando, Florida 32835 (“establishment”), where Petitioner’s records are stored. On or about July 29, 2009, Petitioner submitted the first portions an application to Respondent for a Retail Pharmacy Wholesaler Distributor Permit, pursuant to Subsection 499.01(2)(f), Florida Statutes (“application”). On September 16, 2009, Respondent's drug agents conducted an onsite inspection of the establishment (“inspection”) for purposes of assisting in Respondent’s determination of whether to issue the permit to Petitioner. On or about November 13, 2009, Respondent notified Petitioner that Respondent intended to deny the application (“notice”), and Petitioner filed a petition for administrative review, raising disputes of material fact (“petition”). Prescription Drug Inventory and Petition as a “Retail Pharmacy” To qualify as a retail pharmacy, Petitioner must have adequate inventory on hand that would be required by the general public for a variety of medical conditions. On the date of inspection, there was inadequate inventory on hand. There were only 18 commercially-available prescription drugs. Many of the drugs were injectables, which would only fill the needs of a very specific and limited patient population. At the time of inspection, Petitioner’s on-hand inventory of prescription drugs lacked any opiate painkillers and any drugs indicated for treatment or maintenance of (i) high blood cholesterol levels, (ii) systemic bacterial infections (oral antibiotics), (iii) osteoporosis, (iv) cough (syrups), (v) viral infections, (vi) depression, and (vii) asthma. These are some of the most commonly-required drugs in the pharmacological arsenal. Petitioner’s specialization in the area of compounded prescription drugs is evidenced by Petitioner’s prescription drug inventory and the nature of the prescriptions Petitioner filled in the months leading up to inspection. Most of Petitioner’s on-hand prescription drug inventory was composed of compounded prescription drugs or ingredients to be used in compounding prescription drugs. Less than eight percent of Petitioner's prescription drugs, or about 18 items, consisted of commercially-available prescription drugs in finished dosage forms. In the two-month period before September 29, 2009, Petitioner did not dispense a single dose of commercially- available, finished-form prescription drugs. All were specially-prepared or “compounded” products tailored to the specific needs of individual patients. Petitioner, as a result of an inability to meet the most basic and commonplace prescription drug needs of the general public, lacked adequate inventory required by the general public. Petitioner served a specific and limited patient population: i.e., those patients requiring specially-compounded prescription drugs and those rare patients whose needs could not be met by commercially-available products. Petitioner's explanation as to the reason for having only 18 commercially-available prescription drugs available at the time of inspection is not persuasive; Petitioner, therefore, was not a retail pharmacy. Life Specialty Pharmacy Medical Equipment and Supplies, Inc.: Petitioner’s Unauthorized Source for Prescription Drugs Life Specialty Pharmacy Medical Equipment and Supplies, Inc. (“Life Specialty”), a separate entity from Petitioner, is under common control with Petitioner. It has the same owners, principals, and pharmacy department manager. Life Specialty holds Community and Special Parenteral/Enteral Pharmacy License No. PH22346 for an establishment located at 1507 Park Center Drive, Suite 1L, Orlando, Florida 32835. It is not authorized under Florida law to purchase, receive, own, or distribute prescription drugs. Petitioner’s prescription drug inventory at the time of inspection included certain quantities of Sarapin, a prescription drug. Life Specialty acquired and received Sarapin from a Kmart pharmacy that is no longer in business. At the time Life Specialty acquired and received the Sarapin from Kmart pharmacy, that drug was readily available from Life Specialty’s prescription drug wholesale suppliers. Life Specialty later transferred the Sarapin to Petitioner. Life Specialty lacks any permit or authorization under Part I of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes (Act), to engage in the wholesale distribution of prescription drugs. Petitioner, nevertheless, received prescription drugs from Life Specialty, and many of these drugs were in Petitioner’s prescription drug inventory at the time of inspection, including prescription drugs compounded by Life Specialty. Those drugs included: Sarapin Ketamine Hydrochorlide USP Progesterone Micro USP Chloral Hydrate (CIV), Crystal USP 100% 125gm Testosterone Propionate Micro USP Ketamine Hydrochloride USP 100% Powder 25mg Amphotericin B USP 100% Powder 1gm Cyclobenzaprine HCl USP Recordkeeping and Pedigree Papers During the course of the inspection, Respondent requested the opportunity to review pedigree papers and other source-related records for the prescription drugs Petitioner received from Life Specialty. Specifically, Petitioner could not produce any pedigree papers for prescription drugs received from Life Specialty. Petitioner received from Life Specialty, without a valid pedigree paper, the following: Sarapin Ketamine Hydrochorlide USP Progesterone Micro USP Testosterone Propionate Micro USP Cyclobenzaprine HCl USP Recordkeeping Petitioner did not acquire all of its pedigree papers contemporaneously with the underlying transactions. Petitioner acquired many of the pedigree papers for the prescription drugs in its inventory after the Respondent's inspection. Petitioner's explanation for these failures was not credible.
Recommendation Based on the Findings of Facts and the Conclusion of Law cited above, it is RECOMMENDED that the Department of Health enter a final order, denying Petitioner's application for a permit to act as a retail pharmacy drug wholesale distributor. DONE AND ENTERED this 1st day of September, 2010, in Tallahassee, Leon County, Florida. S DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of September, 2010.
The Issue The issues are whether Respondent failed to maintain an accurate medication record relating to narcotic medications in violation of Section 400.419(1)(b), Florida Statutes, and Rule 58A-5.0185(3)(b), Florida Administrative Code; and if so, what penalty should be imposed.
Findings Of Fact Petitioner has authority to license assisted living facilities (ALFs) and the duty to enforce all statutes and rules governing such facilities. Respondent is a licensed ALF with a total capacity for 35 residents. Respondent's License No. AL5888 is effective March 20, 2002, through March 19, 2004. On January 31, 2002, Petitioner completed a biennial survey of Respondent's facility. During the survey, Petitioner's staff observed Respondent's staff administering medication to six residents who needed medication assistance. Resident No. 6 received a narcotic medication, in tablet form, that she was supposed to take by mouth three times daily, as needed, for pain. The medication is addictive and may be obtained only by prescription. The prescription bottle at issue here indicated that it was filled on January 21, 2002, with 100 tablets. There is no other evidence regarding the number of tablets in the bottle when it arrived at Respondent's facility. Respondent did not count the tablets in the bottle upon receiving it from the pharmacy. Resident 6's MOR showed that she received the narcotic tablet three times daily, everyday, with no missed doses during the time period at issue here. According to the MOR, Resident 6 received a total of 32 doses of the medication beginning January 21, 2002, at 7:00 a.m. through January 31, 2002, at 12:25 p.m. However, the bottle contained only 54 tablets as of January 31, 2002, at 12.25 p.m. Respondent's staff could not explain or account for the 14 missing narcotic tablets. Under cover of a letter dated February 12, 2002, Petitioner advised Respondent that the biennial survey had identified a Class II deficiency relative to Resident 6's medication administration. The letter requested Respondent to file a plan of correction within ten days. Resident 6's narcotic medication was refilled on February 19, 2002, with 100 tablets. As of March 8, 2002, Resident 6 had 51 pills remaining in the new prescription bottle. On March 8, 2002, Petitioner's staff conducted a follow-up visit to Respondent's facility. The count of tablets in Resident 6's narcotic medication prescription bottle, when compared to the MOR, was correct at that time. Under cover of a letter dated March 15, 2002, Petitioner advised Respondent that the previously cited deficiency had been corrected.
Recommendation Based on the foregoing Findings of Facts and Conclusions of Law, it is RECOMMENDED: That Petitioner enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 10th day of October, 2002, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 10th day of October, 2002. COPIES FURNISHED: Michael O. Mathis, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308-5403 Alvin L. Peters, Esquire 25 East Eighth Street Panama City, Florida 32401 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
