The Issue The issues concern the question of whether the discovery of certain deficiencies related to the placement of legend drugs at the bedside of residents within the respondent's facility should be classified as a Class II or Class III deficiency within the meaning of Section 400.23, Florida Statutes.
Findings Of Fact On September 19 through 21, 1983, the State of Florida, Department of Health and Rehabilitative Services made an inspection of the Skilled Nursing Facility, operated by Jacksonville Methodist Home, Inc. as part of the Wesley Manor Retirement Village. That inspection was in keeping with the provisions of Chapter 400, Florida Statutes. The location of the facility is in St. Johns County, Florida. In the course of this inspection, in the room of one of the patients, the legend drugs Nitrol Ointment 2 percent and Aristocort A 0.1 percent Creme were discovered at the bedside of that patient. In another room, related to a second patient, the legend drug Timoptic 0.5 percent Eye Drops was found. Finally, in a third room, the legend drug Granulex Spray was found at the bedside of that patient. Although the patients were relatively alert and there was more than the minimum staffing required of such facilities, certain other ambulatory residents within the facility could have gained admittance into the three rooms where patients were residing for whom the various legend drugs had been prescribed. No indication was given that patients other than those for whom the legend drugs had been prescribed had used these legend drugs or of any other such event in the past history of the facility. While the facility in question had not experienced problems with the patients misusing legend drugs, there have been occasions in the experience of the inspector for the State, Patricia Dill, who is a graduate nurse, in which residents in comparable facilities have entered rooms of other patients and taken drugs not prescribed for that intruder. As indicated in the petitioner's Exhibit No. 2 admitted into evidence, there were 55 patients in the facility on September 19, 1983, of which 37 were listed as confused or disoriented, and 19 patients were under a form of restraint. Twelve patients required no assistance with ambulation and 32 required some form of assistance such as wheelchair, cane, or otherwise. Nitrol Ointment is a timed release nitroglycerin, to be used three times a day, which has the effect of release over an eight hour period and is prescribed for persons suffering angina. If used by a patient for whom it was not prescribed it might cause headaches or vomiting, if ingested. Placing the ointment on the skin would cause a lowering of blood pressure in patients for whom it was not prescribed. Aristocort Creme is a steroid, not for ingestion. If ingested it could cause the patient to feel bad, to include possible vomiting. Placement in the eyes would cause a problem with sight. Timoptic Eye Drops are related to the treatment of glaucoma and would not normally cause problems if swallowed, as opposed to being placed in the eyes. Granulex Spray is an enzyme which attacks dead tissue. Properties that present any danger to the patient would be related to spraying into the eyes. It is the aerosol feature of the Granulex Spray which presents that problem. The misuse of the legend drugs in question would not be expected to be a life-threatening event. Based upon the observations of legend drugs within the patient rooms, respondent is said to have violated the provisions of Rule 10D-25.112 (11), Florida Administrative Code. While the respondent concedes such violation, it disagrees with the petitioner's characterization of this violation as a Class II violation, and requested the formal hearing to challenge that classification.
Recommendation Upon a full consideration of the facts found and the conclusions of law reached, it is RECOMMENDED: That a final order be entered which classifies the violations related to the discovery of legend drugs in the rooms of the residents/patients as Class III deficiencies. DONE and ENTERED this 31st day of August, 1984 in Tallahassee, Florida. CHARLES C. ADAMS Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of August, 1984. COPIES FURNISHED: Jonathan S. Grout, Esquire Department of Health and Rehabilitative Services Post Office Box 210 Jacksonville, Florida 32231 R. Grady Snowden, Jr. Administrator Wesley Manor Retirement Village State Road 13 and Julington Creek Road Jacksonville, Florida 32223 David Pingree, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301
The Issue At issue is whether Respondent committed the offenses set forth in the Administrative Complaint dated March 3, 2000, and, if so, what penalty should be imposed.
Findings Of Fact Respondent, Robert Gibson McLester, III ("McLester") is a licensed pharmacist 2 with a heretofore unblemished record. McLester graduated from the University of Florida with a degree in pharmacy in August 1977. He was licensed by the State of Florida to practice pharmacy in February 1978. He currently holds an Alabama pharmacy license, and was previously licensed in Mississippi but at some point ceased to pay the state's licensing fee; the license thus lapsed by operation of law. McLester received a Master of Science degree in hospital pharmacy from the University of Mississippi in December 1987 and a Master of Health Care Administration from the same institution the following May. McLester entered the Navy as an aviator cadet in June 1965, and was commissioned as a naval aviator in February 1967. He flew 103 missions with Attack Squadron 147 and was honorably discharged as a lieutenant in December 1970. Following a brief stint in the insurance and investment business, McLester applied unsuccessfully to medical school. McLester entered the University of Florida's pharmacy school in September 1974 and following his graduation in August 1977, has been continuously employed as a pharmacist when not pursuing advanced degrees in pharmacy and related fields. Much of McLester's pharmacy employment has been in the Navy, which he reentered in February 1978 as an ensign in the Medical Service Corps. McLester served in a variety of posts before retiring as a lieutenant commander in August 1992, including at the National Naval Medical Center in Bethesda, Maryland, where he supervised in excess of 25 pharmacists and pharmacy technicians in the preparation of an average of 1600 outpatient prescriptions per day. McLester continued the practice of pharmacy as a civilian, working briefly as a relief pharmacist for the Eckerd Drug chain in the Vero Beach area before being hired full time by Winn-Dixie in August 1992. Under McLester's supervision, Store No. 2358 enjoyed high sales volume and was used as a training site for other Winn-Dixie pharmacies. At all times during McLester's employment at Winn- Dixie, reports of annual inspections of his pharmacy conducted by the Agency for Health Care Administration ("AHCA") pursuant to law showed no deficiencies of any kind. McLester worked at the Winn-Dixie Store No. 2358 until June 17, 1998. McLester's separation from Winn-Dixie was voluntary. McLester left Winn-Dixie because he considered the hours assigned to him by his new supervisor, Steve Howard ("Howard") to be "slave hours." Following McLester's departure, sales and customer satisfaction at Store No. 2358 deteriorated. For most of the time relevant to this case, McLester was responsible for filling in the neighborhood of 150 prescriptions per day. That number placed his store at the high end of Winn- Dixie pharmacy productivity. 3 During the course of his employment at Winn-Dixie, McLester had occasion to report approximately a dozen instances of prescription drug fraud to the authorities, including St.Lucie County Detective Scott Silverman (Silverman). Following his resignation from Winn-Dixie, McLester worked briefly with various services which would find him work as a relief pharmacist. On the instructions of Howard, McLester was not permitted to work at any of the Winn-Dixie stores in the area. In October 1998, McLester found full-time employment with Doctors' Clinic Pharmacy in Vero Beach, a "closed pharmacy" which serves only the patients of that multi-specialty practice. During his term of employment at Winn-Dixie, McLester was assisted by about a half dozen pharmacy technicians. Pharmacy technicians are licensed by the state and must work under the close supervision of a registered pharmacist. Tasks which the law permits to be delegated to pharmacy technicians and which, in fact, are typically delegated to a pharmacy technician include ordering drugs, including controlled substances; receiving drugs and other inventory; counting and transferring drugs from their original containers to packages for individual prescriptions; shelf maintenance; department maintenance; and stocking shelves. Other tasks which pharmacy technicians may legally perform, and which were in fact performed by technicians at Winn-Dixie stores, include logging invoices into the computer system for payment; verifying orders shipped into the store; answering telephones; taking refills from patients or doctors provided that there is no change in any element of the prescription (i.e. instructions to the patient, dosage, etc.); requests to doctors to issue new prescriptions on behalf of a patient; preparing labels and delivering filled prescriptions to the pharmacist for final verification. Because of the nature of the tasks delegated to pharmacy technicians, the relationship between pharmacist and technician must be one of, as several witnesses testified, implicit trust. McLester trusted all of the pharmacy technicians with whom he worked at Winn-Dixie. One of the Winn-Dixie pharmacy technicians, Tonya Tipton ("Tipton") betrayed McLester's trust, along with the trust of the State of Florida which licensed her, Winn-Dixie which employed her, and several other pharmacists under whose supervision she worked. Weeks after McLester left Winn-Dixie, Tipton's betrayal of trust was discovered. Soon after, she was fired from Winn-Dixie and subsequently arrested for crimes she allegedly committed in and against the Winn-Dixie pharmacy. Tipton's arrest set in motion a chain of events which led to this Administrative Complaint. Following a work-related injury suffered in the early 1990s, Tipton developed a dependence upon prescription painkilling medication, including the narcotic nasal spray Stadol.4 Unbeknownst to anyone, Tipton devised a scheme by which she could steal Stadol from Winn-Dixie, and also obtain Stadol under a forged prescription. At all times prior to Tipton's firing from Winn-Dixie, she was a trusted employee. Tipton fell under suspicion when she stated to a co- worker that a package would be arriving the following day and that it should not be opened. Store employees opened the package nevertheless and discovered it contained Stadol. Thereafter, a fellow pharmacy technician followed Tipton into the ladies' room and discovered empty bottles of Stadol in the wastebasket. Confronted by store employees about her inappropriate instruction to the co-worker not to open the package, as well as the empty Stadol containers in the ladies' room, Tipton admitted only to taking one bottle of Stadol from the Winn-Dixie pharmacy. Abundant circumstantial evidence suggests that Tipton's dependence upon Stadol led her to commit more than the one offense to which she admitted. McLester had been the primary pharmacist on duty at Store No. 2358 during many of the shifts when Tipton was alleged to have illegally obtained Stadol. Following a criminal investigation by Detective Silverman and the arrest of Tipton, McLester's former supervisor, Howard, lodged a complaint against McLester with the Board of Pharmacy. In his letter of complaint, Howard characterized his complaint as an effort to protect the interests of Winn-Dixie "in case this problem was found out." Howard claimed that Mostafa Macida ("Macida"), who had replaced McLester as the store's primary pharmacist,"discovered" that Stadol was being stolen from the pharmacy but this testimony is rejected as inconsistent with the testimony of numerous individuals who, unlike Howard, had personal knowledge of the events surrounding Tipton's arrest. Macida suspected nothing and discovered nothing. Tipton's employment at Winn-Dixie began in February 1995 when she was hired as a pharmacy technician by McLester.5 In that capacity, Tipton worked not only with McLester, but also with then-Head Technician Ava Forsythe (Forsythe). Forsythe trained Tipton in the technicians' duties, including the various methods by which prescription drugs, both controlled and non-controlled, may be ordered. At all times relevant to this case, there are three ways in which Winn-Dixie pharmacies may procure drugs and medical supplies requiring prescriptions for resale to the public. The primary system is a computer-generated daily order. The system was referred to by many witnesses as "the PDX system" ("PDX"). Technicians, working under the supervision of the pharmacist, would review the order to verify that the required types and quantities of supplies were being ordered. When the order was deemed complete, "the button was pushed" and the order electronically transmitted to Winn-Dixie's major drug supplier, Bindley-Western.6 In theory, the computer would accurately track stock in over 2,000 line items. The computer was supposed to automatically add to the inventory based upon what was ordered, and subtract based upon records of what was actually dispensed to customers. In reality, the computer-generated inventory was corrupt on a daily basis. Because of the PDX system's unreliability, technicians often had to make adjustments by hand so that the computerized records would match what was actually in stock. Orders could also be manually keypunched into a unit called a Telxon, which also transmitted orders to Bindley- Western. The Telxon unit is portable. The size of a telephone, the Telxon unit at Store No. 2358 was generally kept in a drawer when not being used. Finally, drugs can be ordered from Bindley-Western and/or from one of two secondary suppliers used by Winn-Dixie from any telephone, whether or not the telephone is located in a Winn-Dixie store. None of the systems used by Winn-Dixie, either singly or in combination, had the ability to flag the fact that hundreds of bottles of Stadol had been ordered and paid for by Winn-Dixie, yet not placed on the shelves as pharmacy inventory in Store No. 2358, during the period of Tipton's employment. Under Winn-Dixie's system, it is possible for a pharmacy technician to order medications unbeknownst to the pharmacist, to have them paid for by Winn-Dixie, and to physically divert them to his possession before the medications were logged in to pharmacy inventory. Once drugs are properly entered into inventory, it is reasonable to expect that the pharmacist could be aware of large amounts of a drug being stolen from the inventory. Any single incident of placing unauthorized drug orders could take place in the two or three minutes the duty pharmacist might be absent to go to the restroom, or have his attention diverted for any reason. Silverman is an experienced police officer, having served for over two decades in various law enforcement positions in Florida. For nearly five years Silverman has been exclusively assigned to work with pharmacies and other law enforcement agencies in St. Lucie County. Silverman's job is to assist in the prevention and prosecution of crimes involving the misuse of prescription drugs. Silverman's involvement in this case began when Tipton sought him out. Tipton knew Silverman because her husband is a fellow St. Lucie County detective, and Tipton herself was a sworn St. Lucie officer. Tipton approached Silverman to confess that she had taken a bottle of Stadol from the Winn-Dixie store where she worked. Tipton's confession was not provoked by an attack of conscience. Rather, after she was fired by Winn-Dixie, she began damage control. As Silverman's investigation progressed, substantial effort was made to determine how Tipton had diverted Stadol and what, if any, other crimes may have been committed. Documents collected in the course of the investigation revealed that Tipton had developed a dependency on prescription painkillers dating to a back injury in 1990 in which she suffered a herniated disc. Tipton developed a dependency on Stadol in 1996, after dealing with pain related to the 1990 injury. Tipton claimed to Winn-Dixie security supervisor Robert Blakely ("Blakely") that she had told McLester of the problem, and that he referred her to her doctor for help. Ultimately, Silverman arrested Tipton on 17 counts of insurance fraud and one count of felony possession of a controlled substance. No evidence was offered regarding the disposition of Tipton's case. No evidence was presented of what, if any, effort was made to determine from Tipton if McLester had any complicity in her crimes. It was clear to Silverman that while Tipton had figured out a way to illegally divert Stadol to her unauthorized use, as of the date of the final hearing, "nobody knows how it was done." 7 There was conflicting testimony as to precisely how much Stadol was diverted by Tipton over the relevant period of time but Tipton's ability to obtain the drug through the use of fraudulent prescriptions and outright theft was audacious in scale. Stadol was a legend drug until June 1997 when the Drug Enforcement Agency upgraded its status to a Schedule IV controlled substance. Prior to October 19, 1996, Tipton had a legitimate prescription for Stadol. On that date, Les Gessley ("Gessley"), a relief pharmacist at Store No. 2358, approved a new Stadol prescription for Tipton under a legend number. Tipton used this approved prescription number subsequently when she herself prepared numerous unauthorized refills under this same number. Each of these unauthorized refills was listed on daily pharmacy logs certified mostly by McLester, but also by other duty pharmacists as well. Because these unauthorized prescriptions were refills rather than original prescriptions, the duty pharmacist was not required to personally view the original written prescription. McLester was the pharmacist on duty a majority of the days on which Tipton is believed to have diverted Stadol illegally. Somewhere between ten and twenty percent of the Stadol believed to have been unlawfully diverted by Tipton from Store No. 2358 was diverted after McLester had ceased to be employed there. Some of the Stadol obtained by Tipton under fraudulent prescription at Store No. 2358 was obtained on days when McLester was not the pharmacist on duty. In addition to Les Gessley and Mostafa Macida, other pharmacists on duty while Tipton was believed to have engaged in the criminal diversion of Stadol are Ted Kline and Al Leota. McLester admitted knowing Tipton had a problem with Stadol but did not know the extent of her problem. Forsythe told McLester that she thought there might be some Stadol missing from the shelves. When she shared her concern with McLester, he instructed Forsythe not to leave Tipton alone in the pharmacy. No evidence placed McLester's conversation[s] with Tipton and other parties about her use of Stadol in the context of when Tipton's alleged diversions occurred. According to Forsythe's unrebutted testimony, If you were that desperate you could order any medication you wanted on the Telxon machine or verbally order without knowledge of the pharmacist knowing what you were doing. And then when the medication comes in, you pay the invoice. You throw the invoice away. You throw the copy that you received from the computer away. The invoice is paid. The only person that will know about it will be the person at the headquarters that pays the payment on the invoice without knowing what is on it and the person gets the medication. Take the medication home via however and no one is the wiser. Winn-Dixie has no security procedures in place, such as searching handbags or packages, to prevent employee theft in the pharmacy. Winn-Dixie's ordering system is tailor-made to be abused by individuals who are, in Forsythe's words, "that desperate." It is not illegal for pharmacy technicians to fill their own prescriptions. It is possible for a pharmacy technician to fill or refill a prescription without the pharmacist knowing that had been done if he was absent from the pharmacy or had his attention diverted in some fashion. It appears that Tipton refilled her own fraudulent prescription on a number of occasions, but that her preferred method of diverting Stadol was outright theft. The Winn-Dixie system by which the pharmacies are stocked is flawed in a manner which allowed Tipton to divert Stadol without being detected by the duty pharmacist. The Department failed to show that McLester knew or should have known that Tipton had diverted Stadol to her unauthorized use at Store No. 2358.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the charges in the Administrative Complaint be dismissed. DONE AND ENTERED this 17th day of November, 2000, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS 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 17th day of November, 2000.
Findings Of Fact Hilda T. Clark, Respondent, is a registered nurse who holds license no. 21750-2. Evidence adduced during the course of the hearing reveals that during 1961, while Respondent was employed as a private duty nurse at Mount Sinai Hospital in Miami, she withdrew a narcotic drug, to wit: Dilaudid, for her patient, Mrs. Fanny Goldblum on approximately thirty occasions, which she administered to herself instead of the patient. Based on an Information for violation of the Florida Uniform Narcotic Drug Act (Chapter 398.19, F.S.) which was filed on March 15, 1961, the Respondent pled guilty and was placed on probation for a term of seven years on March 31, 1961. Thereafter, on January 12, 1977, the Respondent, while employed as a private duty registered nurse at the University of Miami Hospital and Clinic, converted to her own use a narcotic drug, to wit: Demerol. When confronted with this fact, the Respondent admitted to the Head Nurse, M. Francis, R.N., that she had injected herself with the Demerol and that she was addicted to narcotics for many years. The Respondent does not contest the above allegations and in fact admits that she engaged in the conduct that is alleged in the administrative complaint filed herein. However, she urges that the suspension of her license is unwarranted in these circumstances inasmuch as she was undergoing tremendous pressure based on her mother and spouse's poor health. Additionally, she related an incident wherein she was undergoing tremendous pain and was placed on the medication, Demerol for the relief of pain due to severe herpes zoster infection. Evidence and testimony introduced during the course of the hearing reveal that herpes zoster infection causes severe pain and that to control such pain, her physician, Edward E. Goldman, M.D., prescribed oral Tolwen, Demerol and Dilaudid suppositories. There also was evidence introduced during the course of the hearing which indicated that the Respondent is not now suffering from any drug related problems or addiction and that her professional abilities are beyond question. Respecting the most recent incident which occurred on January 12, 1977, evidence reveals that the Respondent was indeed laboring under a great deal of stress and mental pressures which, in her words, forced her to resort to the unlawful withdrawal and injection of the narcotic drug, Demerol. There was no evidence introduced that the Respondent engaged in any unlawful act during the period between the incident which occurred in 1961 and the January, 1977 incident. Nor was there any further evidence of any drug addiction problem by Respondent subsequent to the January, 1977 incident. The unlawful use of and procurement of drugs by nursing professionals is a serious act which should not be condoned without sanction by the Board of Nursing. It goes without saying that such acts and/or conduct constitutes a departure from the minimal standards of acceptable and prevailing nursing practice and in fact constitutes unprofessional conduct. See Chapter 464.21(b), Florida Statutes. Based on evidence received during the course of the hearing, there is substantial and competent evidence from which a finding can be made that the Respondent engaged in conduct violative of the above chapter i.e., Subsection 464.21(b), Florida Statutes. However, there was no evidence introduced on which a finding can be made that the Respondent is guilty of conduct violative of Chapter 464.21(c) and (d), as alleged. Although two instances of unlawful useage of narcotic drugs was alleged which the Respondent admits, in view of the length of time between the two occurrences, the undersigned concludes that the record fails to establish that the Respondent is habitually addicted to the use of controlled substances as provided in Chapter 464.21(c), Florida Statutes. I shall therefore recommend that the remaining two allegations be dismissed. Respecting the finding that the Respondent engaged in unprofessional conduct within the meaning of Chapter 464.21(b), Florida Statutes, I shall bear in mind and give consideration to the lengthy and creditable service that she has given to the nursing profession, a profession in which she desires to continue to practice. Based thereon and the favorable testimonials received into evidence, I shall recommend that the Respondent be placed on probation for a period of two years.
Recommendation Based on the foregoing findings of fact and conclusions of law I hereby recommend that the Respondent be placed on probation for a term of two years. In all other respects, I hereby recommend that the complaint allegations be dismissed. RECOMMENDED this 12th day of September, 1977, in Tallahassee, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Julius Finegold, Esquire 1005 Blackstone Building Jacksonville, Florida 32202 George A. Kokus, Esquire Cohen and Kokus 500 Roberts Building 28 West Flagler Street Miami, Florida 33130 =================================================================
Findings Of Fact Respondent Dora Villanueva, is a licensed pharmacist, having been issued license number PS 0014957, and whose last known address is 3017 Southwest 107the Avenue, Miami, Florida 33165. At all times material hereto, Respondent Villanueva was the prescription department manager and part-owner of Century Pharmacy, 3017 Southwest 107th Avenue, Miami, Florida 33165. Respondent Century is permitted to operate a community pharmacy under the laws of the State of Florida, having been issued permit number PH 0006839 and operating at 3017 Southwest 107th Avenue, Miami, Florida 33165. On or about August 5, 1983, a Department of Professional Regulation investigator purchased 20 Librax and 20 Donnatal from Century Pharmacy, without first presenting a prescription. The aforementioned Librax and Donnatal were dispensed by Jose Ceferino Calvera, not a licensed pharmacist in the State of Florida. Librax and Donnatal are medicinal drugs as defined in Subsection 465.003(7), Florida Statutes (1983)(F.S.), and require a prescription to be dispensed. Respondent Dora Villanueva was not present in the pharmacy when the Librax and Donnatal were dispensed on August 5, 1983, and the prescription department of the pharmacy had a sign stating that the prescription department was closed. On or about August 17, 1983, a Department of Professional Regulation investigator purchased ten Dalmane, 20 Librax and 20 Donnatal, from Respondent Villanueva at the Respondent Century Pharmacy, Inc. without first furnishing a prescription. Dalmane, Librax and Donnatal are medicinal drugs as defined in Section 465.003(7), F.S. and require a prescription to be dispensed. On or about August 22, 1983, a Department of Professional Regulation investigator purchased ten Tranxene 7.5 mg and ten Dalmane, 30 mg, from Respondent Villanueva at the Respondent Century Pharmacy, Inc., without a prescription. Tranxene and Dalame are medicinal drugs as defined in Section 465.003(7), F.S., and require a prescription to be dispensed. On or about September 8, 1983, an audit was conducted of the controlled substances at Respondent Century Pharmacy, Inc., for the time period of January 1, 1983 through September 8, 1983. Said audit revealed the following shortages in the drugs which were audited: DRUG SHORTAGE Dalmane 30 mg 1,590 Dalmane 15 mg 799 Ativan 1 mg 151 Ativan 2 mg 4,163 Talwin Injectable 22 Dalmane, Ativan and Talwin are controlled substances as defined in Chapter 893, F.S. and are medicinal drugs as defined in Subsection 465.003(7), F.S. Respondent Villanueva denied making the August 17, 1983 sale. However, she did remember Petitioner's investigator from the August 22, 1983, transaction. Since Petititoner's investigator kept a contemporaneous record of her purchases, Respondent's denial is rejected as not credible. Both Respondent Villanueva and Petitioners investigator are immigrants from Cuba. Respondents claim the investigator was allowed to make the August 22, 1983 purchase without a prescription because she stated she had recently arrived from Cuba and had no doctor or money to pay one. Even if this were an accurate account of the transaction (which Petitioner denies) it would not provide grounds for dispensing controlled drugs without a prescription.
Recommendation Based on the foregoing, it is RECOMMENDED: That Petitioner issue a final order suspending the license of Respondent Dora Villanueva and the permit of Century Pharmacy, Inc. for a period of 90 days. DONE and ENTERED this 31st day of July, 1984 in Tallahassee, Florida. R. T. CARPENTER, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of July, 1984. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Blas E. Padrino, Esquire 2355 Salzedo Street, Suite 309 Coral Gables, Florida 33134 Wanda Willis, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against a medical doctor on the basis of alleged violations of paragraphs (m), (q), and (t) of Section 458.331(1), Florida Statutes. The violations charged relate to allegations that the Respondent improperly prescribed legend drugs, including controlled substances, and that he failed to keep certain records.
Findings Of Fact The Respondent is, and has been at all times material to this proceeding, a licensed physician, having been issued license number ME 0026758 by the State of Florida. During 1988 and 1990 the Respondent wrote five prescriptions for a person named V. L. R. The prescriptions were dated 7/9/88, 8/23/88, 9/27/88 11/18/88, and 2/12/90. As of October 22, 1990, the Respondent did not have any medical records in his possession regarding V. L. R. The Respondent has never had any medical records regarding V. L. R. The prescriptions the Respondent gave to V. R. L. included a prescription for 100 tablets of Eskalith CR, 450 milligrams each. Eskalith is a brand name for Lithium. The prescriptions the Respondent gave to V. L. R. also included a prescription for 500 tablets of Lithobid, 300 milligrams each, which is another brand name for Lithium. Before prescribing Lithium, a physician should establish the existence of a mood disorder as a diagnostic basis for the prescription. The diagnosis should be reflected in medical records. When prescribing Lithium, a physician should also monitor the concentration of the drug in the system of the person to whom the drug is prescribed, because the therapeutic level of Lithium is very close to the toxic level of Lithium. If the concentration is too low, the drug is not effective. If the concentration is too high, there can be toxic effects including vomiting, diarrhea, unsteady gait, and the possibility of falling. The prescriptions the Respondent gave to V. R. L. included a prescription for 30 tablets of Ativan, 100 milligrams each. Ativan is a controlled substance which is habit forming. It is a tranquilizer. A physician should not prescribe Ativan without a diagnosis of a sleeping problem or anxiety. The diagnosis should be documented in the medical records of the person to whom the prescription is given. The name of the drug, the dosage, and the times the drug should be taken should all be included in the medical records. The prescriptions the Respondent gave to V. R. L. included a prescription for 100 tablets of Tegretol, 100 milligrams each. Tegretol is an anti-seizure medication that is also used as a mood stabilizer in people who have a major mood disorder. When prescribing Tegretol, a physician should also monitor the concentration of the drug in the system of the person to whom the drug is prescribed, because the drug has the potential for adverse side effects, including inhibition of blood cell production and the production of platelets leading to the risk of infection or bleeding. A physician should not prescribe Tegretol unless a diagnosis of a mood disorder has been made. The diagnosis should be reflected in medical records. A physician should not prescribe Tegretol and Lithobid to the same person unless there have been some difficulties in the treatment of the person and a need for simultaneous prescription of both drugs has been established by the physician. The name of the drug, the dosage, and the times the drug should be taken should all be included in the medical records. The prescriptions the Respondent gave to V. R. L. included a prescription for 100 tablets of Anafranil, 25 milligrams each. Anafranil is a drug prescribed to treat obsessive/compulsive disorder with or without depression. A physician should not prescribe Anafranil without a diagnosis of an obsessive/compulsive disorder. The diagnosis should be documented in the medical records of the person to whom the prescription is given. Any symptoms of depression should also be noted in the medical records. The name of the drug, the dosage, and the times the drug should be taken should all be included in the medical records. When prescribing Anafranil, the physician should monitor the effect of the drug by observation of the person to whom the prescription is given. Such observations should be noted in the medical records. The prescriptions the Respondent gave to V. R. L. included a prescription for 10 tablets of Endep, 25 milligrams each. Endep is a commercial name for amitriptyline, which is an antidepressant. It is used to treat depression. A physician should not prescribe Endep unless a diagnosis of depression has been made. The diagnosis should be included in the medical records. The name of the drug, the dosage, and the times the drug should be taken should all be included in the medical records. The prescriptions the Respondent gave to V. R. L. included a prescription for 15 tablets of Halcion, 25 milligrams each. Halcion is a controlled substance that is used to treat sleeping disorders. A physician should not prescribe Halcion unless a diagnosis of a sleeping disorder has been made and the need for the drug is established. When prescribing Halcion, the physician should monitor the effect of the drug by means of observations of and discussions with the person to whom the prescription was given. The diagnosis of sleeping disorder and the observations and discussions should all be noted in the medical records. The name of the drug, the dosage, and the times the drug should be taken should also all be included in the medical records. The Respondent prescribed quantities of medication that represented a potential danger to V. L. R. The Respondent prescribed excessive or inappropriate quantities of drugs to V. L. R. The Respondent, by providing the prescriptions described above to V. L. R., prescribed legend drugs, including controlled substances, outside the scope of his professional practice.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Board of Medicine issue a Final Order in this case to the following effect: Dismissing the charges alleged in Counts One and Two of the Amended Administrative Complaint; Finding the Respondent guilty of a violation of Section 458.331(1)(q), Florida Statutes, as alleged in Count Three of the Amended Administrative Complaint; and Imposing an administrative penalty comprised of (i) an administrative fine in the amount of one thousand dollars ($1,000.00), (ii) a requirement that the Respondent attend one or more continuing education courses on the subject of legal and ethical issues associated with the prescription of controlled substances, and (iii) a public reprimand of the Respondent for the violation described above. DONE AND ENTERED this 28th day of June, 1994, at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH, 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 Adminsitrative Hearings this 28thday of June, 1994. APPENDIX The following are the specific rulings on all proposed findings of fact submitted by all parties. Findings submitted by Petitioner: Paragraphs 1 and 2: Accepted. Paragraph 3: Rejected as subordinate and unnecessary details. Paragraph 4: Accepted in substance. Paragraph 5: Rejected as not supported by clear and convincing evidence. (It is clear that the Respondent did not make any records of any such examinations or tests, but it is not clearly established that he did not perform the examinations or tests.) Paragraph 6: Rejected as subordinate and unnecessary details. Paragraph 7: Accepted in part and rejected in part. It is clear that the Respondent failed to keep medical records regarding V. L. R.; it is not clear that he "treated" her or that she was a patient. Paragraphs 8 through 36: Accepted. Paragraphs 37 and 38: Rejected for several reasons, including the following: These two paragraphs are to some extent arguments, rather than proposed findings of fact. The opinions described in these two paragraphs are both based on an assumption that was not proved; the assumption that V. L. R. was a patient who was being treated. There is no clear and convincing evidence that V. L. R. was the Respondent's patient. Paragraph 39: Rejected as an invalid and incorrect opinion. The issuance of a prescription does not always constitute treatment of the person for whom the prescription is written. (A classic example of when prescription writing does not constitute treatment is when a prescription is written for a drug to be used for recreational purposes, rather than for a legitimate medical purpose.) Paragraph 40: Rejected as not supported by clear and convincing evidence. (It is clear that the Respondent did not make any records of any history, psychiatric evaluation, or diagnosis of V. L. R., but it is not clearly established that he did not do those things.) Paragraph 41: Accepted. Paragraph 42: Rejected for several reasons. First, the facts proposed in this paragraph were not established by clear and convincing evidence. (McKenzie's testimony about who wrote the notes was hearsay that would not meet one of the recognized hearsay exceptions; Norwich's testimony about who wrote the notes was limited to an unquantifiable "probably.") Paragraph 43: Rejected for several reasons. First the evidence is insufficient to establish what kind of relationship the Respondent had with V. L. R. Second, there is no clear and convincing evidence of a sexual relationship between the Respondent and V. L. R. Third, there is no clear and convincing evidence that V. L. was a patient of the Respondent. Fourth, any findings about a sexual relationship would be irrelevant because there is no allegation in the Amended Administrative Complaint regarding any sexual relationship. Paragraph 44: Rejected because this opinion is based on at least one fact that was not proved at the formal hearing. Paragraph 45: Accepted. Paragraph 46: First three lines and first word of fourth line are accepted. The reference to the sexual relationship is rejected as not charged and as not proved by clear and convincing evidence. Paragraph 47: Rejected because this opinion is based on at least one fact that was not proved at the formal hearing. Findings submitted by Respondent: Paragraph 1: Accepted. Paragraphs 2 and 3: Rejected as subordinate and unnecessary procedural details. Paragraphs 4 and 5: Rejected as not supported by persuasive competent substantial evidence. Paragraph 6: Accepted in substance. Paragraph 7: Rejected as subordinate and unnecessary details. Paragraphs 8 through 10: Accepted in substance, with some subordinate and unnecessary details omitted. Paragraph 11: Rejected as incorrect dates; the correct dates are 1988 to 1990. Paragraph 12: Accepted in substance. Paragraph 13: Rejected as irrelevant. COPIES FURNISHED: Francesca Plendl, Esquire Senior Attorney Department of Business and Professional Regulation 1940 North Monroe Street, Suite 60 Tallahassee, Florida 32399-0792 Harold M. Braxton, Esquire, and Tania Therese Wong, Esquire Suite 400, One Datran Center 9100 South Dadeland Boulevard Miami, Florida 33156 Jack McRay, General Counsel General Counsel Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dr. Marm Harris Executive Director Board of Medicine Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact Based upon the entire record, the following findings of fact are determined: Background At all times relevant hereto, respondent, Obi E. Enemchukwu, was licensed as a pharmacist having been issued license number PS 0023082 by petitioner, Department of Professional Regulation, Board of Pharmacy (Board). He has been licensed as a pharmacist since 1981. There is no evidence that respondent has been the subject of disciplinary action prior to this occasion. When the events herein occurred, respondent was the designated prescription department manager and pharmacy permittee for Oviedo Drug World (ODW), a community pharmacy located at 83 Geneva Drive, Oviedo, Florida. A community pharmacy is not defined by statute or rule. However, a Board witness described such a pharmacy as being a drug store that serves customers in an outpatient or ambulatory setting. As the prescription manager for the pharmacy, respondent was responsible for maintaining all drug records, providing for the security of the prescription department, and following all other rules governing the practice of pharmacy. Count I This count alleges that respondent violated a Board rule by virtue of the ODW prescription department being "opened at 9:00 a.m. with a pharmacy technician only on duty with no pharmacist present until approximately 9:15 a.m.". In this regard, the evidence shows that on February 28, 1991, a DPR senior pharmacist, Charles C. Lewis, made a routine inspection of ODW. He entered the premises at approximately 9:00 a.m. and found the drug store open, the lights on in the pharmacy section, and only a pharmacist technician on duty. Respondent was not on the premises. Respondent eventually entered the premises around 9:10 a.m. Because the law requires that a registered pharmacist be on duty whenever a community pharmacy is open, respondent, as the designated manager, was in contravention of that requirement. Count II The second count alleges that "on one occasion in approximately August 1990, pharmacist technicians on duty were required to dispense medicinal drugs despite no pharmacist having been present". As to this charge, respondent admitted without further proof that the allegations were true. Thus, the charge in Count II has been sustained. Count III The third count alleges that "on at least two occasions refills for medicinal drugs were dispensed without authorization from the prescribing physician." As to this count, during the course of his inspection of ODW's prescription file, Lewis found copies of two original prescriptions dispensed by respondent on Saturday, February 9, 1991, and Saturday, February 16, 1991, respectively. Original prescriptions are those either handwritten by a doctor and brought in for filling by the patient or those that are telephoned in to the pharmacy by the doctor's office. If a prescription is telephoned in, it must be immediately reduced to writing by the pharmacist. Original prescriptions do not include refills. In this case, the two prescriptions were the type telephoned in by the doctor directly to the pharmacy. Because doctors are rarely in their offices on Saturday, Lewis turned the prescription records over to DPR for further investigation. The records of the prescriptions have been received in evidence as a part of petitioner's exhibits 1 and 2. The prescriptions indicate that Dr. James E. Quinn prescribed thirty Nalfon tablets (600 mg.) to patient L. C. on February 9, 1991, and Dr. Michael E. Meyer prescribed ten Tagamet tablets (300 mg.) to patient J. K. on February 16, 1991. The record does not disclose whether the drugs are scheduled legend drugs or non-scheduled legend drugs. Deposition testimony given by Drs. Quinn and Meyer established that neither doctor authorized by telephone or in writing that the two prescriptions in question be filled. Respondent concedes that he dispensed the drugs, and by doing so, he violated the law. Count IV The final count alleges that respondent, as a pharmacy permittee, violated former rule 21S-1.023 (now renumbered as rule 21S-28.112) by dispensing a medicinal drug in violation of state law. Because this charge is founded on the same set of facts set forth in findings of fact 4, 5 and 6, it is found that this charge has been sustained. Mitigation and Penalty At hearing, respondent generally offered mitigating testimony. As to Count I, he indicated he planned to arrive at the store at 9:00 a.m. but an automobile accident tied up traffic and caused him to be ten minutes late. He suspects that the store owner, who had the only other set of keys, opened up the store and pharmacy area and improperly let the technician into the pharmacy area even though respondent had not yet arrived. As to Count II, respondent acknowledged that two prescriptions were dispensed by pharmacy technicians without a pharmacist on duty but believes the store owner authorized the technician to dispense two prescriptions that he had filled the previous evening. He says appropriate instructions have been given to insure that this will not occur again. Finally, respondent gave the following explanation for dispensing the two prescriptions without authorization from a doctor. During the time period in question, respondent had a practice of partially filling prescriptions. In other words, even though a prescription might authorize a total of 100 tablets, respondent would dispense them piecemeal (e.g., 10 at a time) over the life of the prescription. Thus, at the end of the prescription period, if only 80 of 100 tablets had been previously dispensed, he would fill the remaining 20 tablets even though the prescription from a particular doctor had expired. In the case of the two prescriptions in issue, respondent believes that the customers either had a valid prescription from another doctor but he inadvertently refilled the prescription using the former doctor's name because the prescription had not been used up, or he noted that the patient had not been given the total number of tablets authorized under the original prescription. However, no documentation was submitted by respondent to support the claim that he was presented with a new valid prescription by one of the customers. Respondent apparently no longer engages in this practice. Finally, throughout the course of this proceeding, respondent has fully cooperated with the Board. Although the Board did not submit a proposed order containing a recommended penalty, at hearing counsel for the Board suggested that respondent's conduct warrants the imposition of a fine, probation and a reprimand.
Recommendation Based upon the foregoing findings of facts and conclusions of law, it is RECOMMENDED that respondent be found guilty of violating Sections 465.014, 465.015(2)(c), 465.016(1)(e)and (n), and 465.023(1)(c), Florida Statutes (1989), and that he be given a reprimand, fined $500 and his license placed on probation for one year. DONE and ENTERED this 12th day of March, 1992, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of March, 1992. COPIES FURNISHED: Tracey S. Hartman, Esquire 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Obi E. Enemchukwu P. O. Box 32 Tavares, FL 32778-0032 Jack L. McRay, Esquire 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 John Taylor, Executive Director Board of Pharmacy 1940 North Monroe Street Tallahassee, FL 32399-0792
Findings Of Fact At all times pertinent to the allegations contained herein, Respondent was licensed as a naturopath in Florida under license number NA0000530, issued by the State of Florida, and maintained an office for his practice at 7202 East Broadway, Tampa, Florida. The Petitioner, Board of Medicine, is the state agency charged with regulating the practice of naturopathy in Florida. Pursuant to an ongoing investigation, on September 24, 1987, Detective Robert S. DuBose, acting in an undercover capacity in the name of Robert Adams, went to the Respondent's office to try to buy a controlled drug. He was accompanied by several other police officers and Mr. Fierman-Rentas, a DEA agent, all of whom remained outside in a car across the street, attempting to record the transmission from the body brig Mr. DuBose was wearing. On entering the Respondent's office, Mr. DuBose introduced himself to the doctor and told him he had been cut off from his prior source of Valium pills formerly supplied by an unstated friend. When the Respondent asked DuBose why he wanted the Valium, DuBose replied that nothing was wrong with him but that the Valium just made him feel good. Dr. Helland took DuBose's temperature, blood pressure, and pulse rate, stating at the time that he had to have some support for the prescription but that he knew nothing was wrong with DuBose. As a matter of fact, at that time, DuBose was under the care of another physician for a stomach condition not treated by Valium, but did not advise Respondent of this. DuBose's actual condition had no bearing on his relationship with the Respondent. During their conversation, Respondent asked DuBose how long he had been taking Valium and DuBose replied that though he had been taking it for 6 months, he was not sick but just wanted it because of how it made him feel. Respondent indicated he knew DuBose had nothing wrong with him but he had to put something down in his records. As a result, DuBose laughingly stated he was nervous. After filling out a small card on which he wrote some of the information given him by DuBose, Respondent then wrote out a prescription for Robert Adams for 30 tablets of 10 mg Valium for which DuBose paid him $30.00. At no time did Respondent take a proper medical history from DuBose or ask him if he was under the care of another physician. Valium is the commercial brand name of Diazepam, a Schedule IV controlled substance. On October 1, 1987, DuBose returned to Respondent's office, again accompanied by the other officers who waited in cars across the street. DuBose asked for a refill of his prescription and after Respondent asked DuBose what his name was and looked at his patient card, he indicated that DuBose was three days early for a refill. Thirty pills, prescribed for use at the rate of three a day, would not be used up for 10 days. When Respondent pointed this out, DuBose indicated he had given some to his girlfriend. Dr. Helland responded that he didn't care what DuBose did with them, but that he should come for a refill only every 10 days. However, Respondent stated that since he had obviously not explained that fully on the prior visit, he would write another prescription for 30 Valium tablets which he did after giving DuBose a cursory examination. When DuBose asked if an exam would be necessary each visit, Respondent stated that it would. Respondent seemed concerned that DuBose not suffer any side effects from the Valium and counselled him to stop taking them. Nonetheless, he wrote out the prescription which he gave to DuBose upon payment of a $30.00 fee. Again, DuBose indicated no medical support for a prescription for Valium. DuBose went back to Respondent's office on October 27, 1987, this time in the company of Detective Sinclair, also under cover as Donald Simpson, a construction worker. Sinclair waited in the waiting room while DuBose saw Respondent who took his pulse and blood pressure and listened to his heart and lungs. When DuBose asked why they had to go through that each time, Respondent replied that he had to make sure DuBose was all right. After receiving his third prescription for 30 Valium tablets from the Respondent, DuBose asked him if he could see his friend. Respondent asked what was wrong with the friend and DuBose stated he didn't think anything was wrong. Respondent stated then that he'd have to have some reason to prescribe for Sinclair. DuBose then got Sinclair, introduced him to the doctor, and left them alone. Sinclair had a brief introductory conversation with the Respondent during which Respondent asked what he wanted. Sinclair indicated he wanted Percodan, a Schedule II drug, because it made him feel good. Respondent would not prescribe Percodan for Sinclair stating he needed something more to justify any prescription. Respondent asked if Sinclair were nervous or needed something to help him sleep, which Sinclair denied. Respondent then said he had to have some "damned" thing to justify a prescription. Sinclair continued to decline to say more than it made him feel better. Respondent ultimately indicated that Sinclair must be nervous and needed a tranquilizer and Sinclair finally agreed. Respondent then took some personal information from him, took his blood pressure, temperature, and pulse, and listened to his heart and lungs. He then wrote out a prescription for 30 Valium tablets, whereupon Sinclair paid him $30.00 and left. At no time did Respondent take any medical tests or ask if Sinclair was under the care of another physician. When DuBose again went to Respondent's office, on November 19, 1987, he had Detective Stanbro with him posing as his girlfriend. As previously done, Respondent took his blood pressure and did a cursory examination during which DuBose said he felt good. Respondent wrote out a prescription for 30 Valium and DuBose asked if the doctor would prescribe Percodan as well. Respondent refused to do so. DuBose then asked Respondent to see his "girlfriend", introduced her, and left after paying for his own visit and prescription. At no time did DuBose ever indicate to the Respondent he had any ailment. In fact, he always said he felt good. When Respondent indicated he needed some medical justification to prescribe Valium, DuBose told him to put down that he was nervous and could not sleep. Respondent never tried to find a legitimate cause for that condition but instead merely conducted a cursory examination. He never asked if DuBose was under the care of another physician or if he was taking any medication. The first visit lasted about 15 minutes and the others were shorter. It is clear, therefore, that the "examinations" conducted by the Respondent of DuBose and Sinclair were no more than shadow exercises to justify writing a prescription and had no basis in actual medical diagnosis or treatment. When Ms. Stanbro saw the Respondent on November 19, 1987, he immediately saw there was nothing wrong with her and refused to give her a prescription for anything other than aspirin. He denied her request for Percodan and Valium even though he did no examination of any sort. Stanbro was with the doctor for only about a minute and a half. When he turned her down for both drugs, she left. At all times in his relationship with Ms. Stanbro, Respondent acted in a professional manner.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Respondent's license as a naturopathic physician in Florida be revoked. RECOMMENDED this 8th day of August, 1988, at Tallahassee, Florida. ARNOLD H. POLLOCK, 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 8th day of August, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 88-1318 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: DPR 1 - 2. Accepted and incorporated in Findings of Fact 1. 3. Accepted and incorporated in Findings of Fact 6. 4 - 8. Accepted and incorporated in Findings of Fact 2-5. 9 -10. Accepted and incorporated in Findings of Fact 7. 11 - 19. Accepted and incorporated in Findings of Fact 8-9. For the Respondent: Dr. Helland 1 - 3. Accepted and incorporated in Findings of Fact 1. 4 - 5. Accepted. 6. Accepted and incorporated in Findings of Fact 6. 7. Accepted. 8 - 12. Accepted and incorporated in Findings of Fact 2-5. 13 - 16. Accepted and incorporated in Findings of Fact 7. 17 - 20. Accepted and incorporated in Findings of Fact 8-9. 21 - 23. Accepted and incorporated in Findings of Fact 10-11. 24. Accepted as a restatement of testimony and not a Finding of Fact. 25 - 26. Accepted and incorporated in Finding of Fact 9. Accepted as a restatement of testimony and not a Finding of Fact. Accepted and incorporated in Finding of Fact 12. Rejected as a comment in the evidence and not a Finding of Fact. COPIES FURNISHED: John R. Alexander, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 John M. Fitzgibbons, Esquire Suite 1550 600 North Florida Avenue Tampa, Florida 33602-4505 Dorothy Faircloth, Executive Director DPR, Board of Medicine 130 North Monroe Street Tallahassee, Florida 32399-0750
Findings Of Fact At all times relevant hereto, William E.P. Shaw was licensed as a pharmacist in the State of Florida, having been issued license number 0008802. On January 21, 1986, Respondent, in the United States District Court for the Northern District of Georgia, pleaded guilty and was convicted of the offense of conspiracy to obtain drugs at a low purchase price under false and fraudulent pretenses and representations to various drug manufacturers that drugs were for use in Palms of Pasadena Hospital, St. Petersburg, Fla., which drugs were then diverted from said hospital use and resold at substantial profit, this being done by use of interstate Wire Communications and the U.S. Mail - all in violation of Section 1343, and 1341 and 2 - Title 18, and 371 - Title 18, U.S.C., as charged in the within indictment. (Exhibit 1). At the time of the alleged offense, Respondent was a staff pharmacist at Palms of Pasadena Hospital. Prior thereto he headed a company or group which managed several hospital pharmacies including that of Palms of Pasadena. His contract with Palms of Pasadena Hospital expired in 1984 and was not renewed. Drug manufacturers sell drugs to hospitals at a much lower price than they sell to wholesalers. Respondent set up an account on which the hospital comptroller had check writing authority, and as a pharmacist ordered specific drugs under the hospital's drug account number to be delivered to the hospital. Upon arrival at the hospital these drugs were immediately reshipped to a contact in Miami, who was a licensed drug wholesaler, or to a contact in Atlanta, who was not so licensed. To the hospital's price for the drugs, which was paid by the hospital's comptroller from the account established by Respondent, Respondent added ten percent. This sum was remitted to him by these two purchasers and the account from which the supplier was paid was reimbursed. Respondent testified that he was unaware that his scheme was in violation of the law; however, Respondent was aware that he was defrauding the drug companies and violating the hospital's agreement with these companies to dispense all drugs purchased only to hospital patients. Drugs so ordered and resold by Respondent were primarily prescription drugs slow-K and nitro patches. Following his conviction in the U.S. District Court Respondent was sentenced to three years imprisonment the execution of which was suspended and Respondent was placed on probation for three years, ordered to pay a fine of $7,500.00 and perform 400 hours of community service work (Exhibit 1). At the time of this hearing, Respondent had satisfied the sentence but for the unexpired probation. Respondent has been a licensed pharmacist since 1958 and, but for the federal charge and conviction, has enjoyed a good reputation in the field of pharmacy and in the community in which he lived.
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.
