Findings Of Fact At all times relevant hereto, respondent, Cuca Pharmacy, Inc. (Cuca), held community pharmacy license number PH007348 issued by petitioner, Department of Professional Regulation Board of Pharmacy. When the events herein occurred, Hortensia Lopez-Perez was its president and permittee. Its location is 11048 West Flagler Street, Miami, Florida. After the events herein occurred, the pharmacy was closed by emergency suspension order and it has remained closed since that time. In February, 1984 special agent Alberto Fernandez was performing undercover operations in the Miami area for the Drug Enforcement Agency (DEA) for the purpose of enforcing federal narcotic laws. On February 17, he received information from an informant that ten kilograms of cocaine could be purchased for $21,000.00 per kilogram from two individuals named Zayas and Santos. He was told the cocaine was stored at respondent's pharmacy. Fernandez met the two "dealers" in Hialeah but Zayas and Santos were unable to produce any drugs. Consequently, no sale took place. On February 25, Fernandez again received a telephone call from his informant and was told to go to Cuca and meet an individual named Jesus Avila who was interested in selling some cocaine. Fernandez, Avila and the informant met in the rear of the pharmacy where Avila agreed to sell ten kilograms of cocaine to Fernandez for an undisclosed price. They further agreed to meet in a nearby shopping center where Fernandez would show his money and Avila would show the drugs as a good faith gesture. If both parties were satisfied, they agreed to then make the transfer at Cuca. Fernandez went to the shopping center but when Avila did not appear at the designated time, Fernandez returned to Cuca. Respondent's permittee, Hortensia Perez, advised him the drugs were on the way and not to worry. Later on that day, Fernandez received a telephone call from his informant advising that two kilograms had just arrived at Cuca and to return there for the buy. When he returned he met Avila and Lopez-Perez and went to the back of the store. Avila told Fernandez he couldn't sell cocaine that day but could arrange to do so in a few days. On February 29, Fernandez received another telephone call from his informant who advised him that the cocaine was at Cuca and to be there at 3:00 p.m. At the designated time, Fernandez, the informant and Lopez-Perez went to the rear of the pharmacy where Lopez-Perez pulled a clear plastic bag containing a white powdery substance from a metal cabinet and gave it to Fernandez. The transfer of the substance was made without a prescription. Lopez-Perez was then arrested for allegedly violating federal narcotic laws. The contents of the bag were later subjected to a chemical analysis and found to weigh 2.2 pounds (one kilogram) and to be 95 percent pure cocaine hydrochloride, a controlled substance and legend drug which requires a prescription for dispensing. Records of Miami area drug wholesalers introduced into evidence reflected that Cuca had not ordered any cocaine for prescription purposes between 1982 and June, 1984. This was confirmed by testimony from Cuca's prescription department manager. Lopez was charged with one count of conspiring to possess with intent to distribute a controlled substance (cocaine) in violation of Title 21, U.S.C., Section 846, and with one count of possessing with intent to distribute a controlled substance (cocaine) in violation of Title 21, U.S.C., Section 841(a)(1) and Title 18, U.S.C., Section 2. She was found guilty on both counts, and a certified copy of the judgment and probation/commitment order dated August 16, 1984 was received in evidence. That document reflects she was sentenced to five years confinement and three years of special parole on count two and five years probation on the first count. Lopez is free on bond while she appeals that judgment.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty as charged in the first and second administrative complaints and that its license as a community pharmacy be REVOKED. DONE and ORDERED this 13th day of January 1986, in Tallahassee, Florida. DONALD R. ALEXANDER 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 13th day of January, 1986.
The Issue The issue in this case is whether certain statements by officials of Respondent Department of Business and Professional Regulation, Division of Alcoholic Beverages and Tobacco (ABT), constitute an unpromulgated rule that is invalid pursuant to Subsection 120.54(1)(a), Florida Statutes (2006).1/
Findings Of Fact The Parties Petitioner TWM is a licensed retail vendor of alcoholic beverages. It operates nine stores in Florida that sell alcoholic beverages, including distilled spirits, by the package. Respondent ABT is the state agency authorized by Section 561.02, Florida Statutes, to regulate the alcoholic beverage industry, including manufacturers, distributors and vendors of alcoholic beverages within the State of Florida. Intervenor ABC is a licensed retail vendor of alcoholic beverages, holding in excess of 100 licenses authorizing the sale of alcoholic beverages, including distilled spirits, by the package. The Alleged Unpromulgated Rule Florida has a three-tiered system of alcoholic beverage distribution. Manufacturers produce the product and sell to distributors, distributors sell the product at wholesale to licensed vendors, and vendors sell the product to the general public at retail. §§ 561.14(1)-(3), Fla. Stat. The term "in-store servicing" refers generally to activities by distributors or manufacturers on the vendor's premises, such as placing stock on shelves, rotating stock, and affixing prices. On April 4, 2007, Renee Alsobrook emailed a message to John Harris, a governmental consultant, which included the following statement: In researching the coupon rule, I reviewed prior opinions I had provided and determined that this opinion provided to you in March, 2006, was wrong. I WAS WRONG. Section 561.424, F.S., clearly excludes in-store servicing of distilled spirits. Please communicate the position of ABT to your wholesalers and Trone. On April 24, 2007, Stephen Hougland emailed the following message to Mr. Harris: John, after considerable research and consultation, ABT's opinion is that FL law does not permit in-store servicing for spirits. I'd be glad to talk to you about the decision as I am sure you are concerned about the impact on your clients. These two email messages were cited by TWM in its Petition as expressions of a new policy that has not been adopted as a rule and is, therefore, invalid and unenforceable. In the course of discovery, other written statements by ABT employees were found that were also made in April 2007, which TWM contends are expressions of the new policy. In a letter dated April 9, 2007, from Lisa Comingore, assistant general counsel for DBPR, to Charles Bailes of ABC, Ms. Comingore states: Wholesalers and manufacturers of distilled spirits are not authorized to provide in- store servicing by section 561.424, Florida Statutes and would be providing aid to retailers in the form of providing labor for the retailer. Such aid to the retailer could constitute a violation of section 561.42, Florida Statutes. In a letter dated April 30, 2007, from Director Hougland to Mr. and Mrs. John Schaeffer of Great Spirits Liquor & Fine Wine, Director Hougland states: Florida law allows in-store servicing of beer and malt beverages as well as vinous beverages, however, in-store servicing of distilled spirits is not authorized . . . Section 561.424(2), Florida Statutes, specifically excludes in-store servicing of distilled spirits. Wholesalers and manufacturers of distilled spirits are not authorized to provide in- store servicing by section 561.424, Florida Statutes and would be providing aid to retailers in the form of providing labor for the retailer. Such aid to the retailer could constitute a violation of section 561.42, Florida Statutes. The Governing Statutes The federal government and many states, including Florida, enacted "Tied House Evil" laws to prevent the "evils" that arose from relationships between vendors of alcoholic beverages and manufacturers and distributors which caused the vendors to be controlled by or "tied" to the distributors and manufacturers. Winn Dixie Stores, Inc., v. Schenck Co., 662 So. 2d 1021, 1023 (Fla. 5th DCA 1995); Musleh v. Fulton Distributing Co. of Florida, 254 So. 2d 815, 817 (Fla. 1st DCA 1971). Florida's Tied House Evil law, set forth in Subsection 561.42(1), Florida Statutes, provides: No licensed manufacturer or distributor of any of the beverages herein referred to shall have any financial interest, directly or indirectly, in the establishment or business of any vendor licensed under the beverage laws; nor shall such licensed manufacturer or distributor assist any vendor by any gifts or loans of money or property of any description or by the giving of any rebates of any kind whatsoever. No licensed vendor shall accept, directly or indirectly, any gift or loan of money or property of any description or any rebates from any such licensed manufacturer or distributor; provided, however, that this does not apply to any bottles, barrels, or other containers necessary for the legitimate transportation of such beverages or to advertising materials and does not apply to the extension of credit, for liquors sold, made strictly in compliance with the provisions of this section. ABT contends that Subsection 561.42(1), Florida Statutes, prohibits in-store servicing of alcoholic beverages by distributors or manufacturers because it constitutes a gift of "free labor" to the vendor. TWM does not dispute ABT's interpretation of Subsection 561.42(1), Florida Statutes, as prohibiting in-store servicing as a form of gift, but TWM contends that subsequent legislation resulted in the removal of the prohibition. In 1975, Section 561.423, Florida Statutes, created an exception for in-store servicing of beer and malt beverages: Nothing in s. 561.42 or any other provision of the Beverage Law shall prohibit a distributor of beer or malt beverages from providing in-store servicing of malt beverages. "In-store servicing" as used herein means quality control procedures which include, but are not limited to: rotation of malt beverages on the vendor's shelves, rotation and placing of malt beverages in vendor's coolers, proper stacking and maintenance of appearance and display of malt beverages on vendor's shelves, price stamping of malt beverages on vendor's licensed premises, and moving or resetting any product or display in order to display a distributor's own product when authorized by the vendor. In 1977, Subsection 561.424(2), Florida Statutes, created an exception for in-store servicing of wine: Nothing in s. 561.42 or any other provision of the Alcoholic Beverage Law shall prohibit a distributor of wine from providing in- store servicing of wine sold by such distributor to a vendor. "In-store servicing" as used herein means: placing the wine on the vendor's shelves and maintaining the appearance and display of said wine on the vendor's shelves in the vendor's licensed premises; placing the wine not so shelved or displayed in a storage area designated by the vendor, which is located in the vendor's licensed premises; rotation of vinous beverages; and price stamping of vinous beverages in a vendor's licensed premises. This section shall not apply to distilled spirits. (Emphasis added) No similar statute was created to expressly authorize in-store servicing of distilled spirits by distributors. After the enactment of Section 561.423 and Subsection 561.424(2), Florida Statutes, there should have been little doubt that the Tied House Evil law was intended by the Legislature to prohibit in-store servicing of alcoholic beverages and that only by express exception was in-store servicing of beer and wine by distributors permitted.2/ The only evidence in the record that tends to explain why distilled spirits were treated differently from beer and wine with regard to in-store servicing is a statement made by Charles Bailes of ABC in a letter to Ms. Alsobrook that, "Historically, in-store servicing of perishable products such as wine and beer have been allowed so as to maximize freshness and minimize the chances of consumers purchasing spoiled merchandise." Mr. Bailes goes on to state that distilled spirits are not perishable. Florida Administrative Code Rule 7A-4.058 The main cause of the current confusion about in-store servicing of distilled spirits can be traced to a rule adopted by ABT in 1985. The year before, Subsection 561.42(12), Florida Statutes, was amended to add the following directive: The Division shall make reasonable rules governing promotional displays and advertising, which rules shall not conflict with or be more stringent than the federal regulations pertaining to such promotional displays and advertising furnished vendors by distributors and manufacturers. ABT responded by promulgating Florida Administrative Code Rule 7A-4.058, entitled "Promotional Displays and Advertising," effective January 2, 1985. The rule adopted certain federal regulations by reference: The Division adopts by reference the provisions of subpart D, Chapter 6, of Title 27, Code of Federal Regulations, regulations 6.81 through 6.101 inclusive. It shall be a violation of Section 561.42, F.S., for any vendor to accept or for any manufacturer or distributor to give a retailer promotional displays, advertising or other such items, services or assistance governed by the regulations adopted by subsection (1) when given in a manner not in strict conformity with the adopted regulations. Subpart D was entitled "Exceptions" and established exceptions to the federal Tied House Evil law. It included exceptions clearly related to promotional displays and advertising, such as "Product Displays," "Inside Signs," "Retailer Advertising Specialties," "Consumer Advertising Specialties," and "Advertising Services." However, Subpart D also included exceptions on subjects that did not appear to involve promotional displays or advertising, such as "Educational Seminars" (for the employees of vendors), "Participation in Retailer Association Activities," "Joint Ventures," "Coil Cleaning Service," and "Stocking, Rotation and Pricing Services." Section 6.99 of the federal regulations, entitled "Stocking, Rotation and Pricing Services," provided: Industry members may, at a retail establishment, stock, rotate and affix the price to distilled spirits, wine, or malt beverages which they sell, provided products of other industry members are not altered or disturbed. The rearranging or resetting of all or part of a store or liquor department is not hereby authorized. Because stocking, rotation, and pricing services are synonymous with in-store servicing, ABT's adoption of Section 6.99 by reference in Florida Administrative Code Rule 7A-4.058 authorized in-store servicing of distilled spirits by distributors and manufacturers in Florida, in apparent conflict with the governing statutes. The adoption by reference of Section 6.99 also conflicted with Section 561.423 and Subsection 561.424(2), Florida Statutes, because these statutes only authorized in-store servicing of beer and wine by distributors, but the federal regulation authorized in-store servicing by "industry members," a term that includes manufacturers. Soon after the adoption of Florida Administrative Code Rule 7A-5.048, ABT's 1986 compliance guidelines included a statement that "27 CFR 6.99 and F.S.S. 561.424" authorize "manufacturers or distributors of distilled spirits or wine to stock, rotate and affix the price to their products at a licensed retailer's premises." ABT's 1988, 1993, and 1995 compliance guidelines contained the same statement.3/ Promotional Displays and Advertising The term "promotional displays and advertising" is not defined in Chapter 561, Florida Statutes, but insight into the Legislature's intended meaning for the term can be gleaned from the 1985 amendment of Subsection 561.42(12), Florida Statutes. Following the sentence that directs ABT to adopt rules regarding promotional displays and advertising, the 1985 amendment added "provided, however," followed by eight new paragraphs dealing with specific situations involving promotional displays and advertising: If a manufacturer or distributor of malt beverage provides a vendor with expendable retailer advertising specialties such as trays, coasters, mats, menu cards, napkins, cups, glasses, thermometers, and the like, such items shall be sold at a price not less than the actual cost to the industry member who initially purchased them, without limitation in total dollar value of such items sold to a vendor. Without limitation in total dollar value of such items provided to a vendor, a manufacturer or distributor of malt beverage may rent, loan without charge for an indefinite duration, or sell durable retailer advertising specialties such as clocks, pool table lights, and the like, which bear advertising matter. If a manufacturer or distributor of malt beverage provides a vendor with consumer advertising specialties such as ashtrays, T-shirts, bottle openers, shopping bags, and the like, such items shall be sold at a price not less than the actual cost to the industry member who initially purchased them, but may be sold without limitation in total value of such items sold to a vendor. A manufacturer or distributor of malt beverage may provide consumer advertising specialties described in paragraph (c) to consumers on any vendor’s licensed premises. Coupons redeemable by vendors shall not be furnished by distributors of beer to consumers. Manufacturers or distributors of beer shall not conduct any sampling activities that include tasting of their product at a vendor’s premises licensed for off-premises sales only. Manufacturers and distributors of beer shall not engage in cooperative advertising with vendors. Distributors of beer may sell to vendors draft equipment and tapping accessories at a price not less than the cost to the industry member who initially purchased them, except there is no required charge, and a distributor may exchange any parts which are not compatible with a competitor’s system and are necessary to dispense the distributor’s brands. A distributor of beer may furnish to a vendor at no charge replacement parts of nominal intrinsic value, including, but not limited to, washers, gaskets, tail pieces, hoses, hose connections, clamps, plungers, and tap markers. None of the examples in the statute suggest that in-store servicing of alcoholic beverages comes within the Legislature's intended meaning of promotional displays and advertising. The common meanings of the words "stocking," "rotation," and "pricing" do not match up with the common meanings of the words "promotional displays" and "advertising." As noted above, there were other federal exceptions adopted by reference in Florida Administrative Code Rule 7A-4.058 that involved neither promotional displays nor advertising. ABT offered no explanation for the agency's indiscriminate adoption by reference of all the federal regulations in Subpart D, including those regulations that were not related to promotional displays and advertising. ABT now acknowledges that the 1985 rule was "non-compliant" with statutory law. TWM presented no evidence to show that stocking, rotation, and pricing are, as a matter of fact, forms of promotional displays or advertising. Instead, TWM argues that ABT's 1985 adoption by reference of Section 6.99 and ABT's subsequent representations that in-store servicing of distilled spirits was authorized in Florida, "determined" and "defined" in-store servicing as a promotional display or advertising. ABT changed its position sometime after 1995. In 1997, ABT repealed Florida Administrative Code Rule 7A-4.058 (which had been renumbered 61A-4.058). Although ABT replaced that rule with a new rule that regulated promotional displays and advertising, the new rule did not adopt any federal regulations by reference and the subject of stocking, rotation, and pricing services was abandoned, along with some of the other subjects covered by the federal regulations previously adopted by reference.4/ ABT's repeal of Florida Administrative Code Rule 61A-4.058 and its adoption of Florida Administrative Code Rule 61A-1.010 in 1977 was announced in public notices published in the Florida Administrative Weekly and through industry bulletins. Two public hearings were held on Florida Administrative Code Rule 61A-1.010, which were attended by industry representatives. The rule prohibited any gift from distributors or manufacturers to vendors that was not specifically identified in the rule or specifically authorized by statute. In-store servicing of distilled spirits is not listed in the rule and, as discussed above, is not specifically authorized by statute. In 1998, ABT issued an industry bulletin to industry representatives on the specific subject of in-store servicing. The bulletin notes that there is no statutory exception for in-store servicing of distilled spirits as there is for beer and wine and states that "Unauthorized services to a vendor would be considered a gift of financial assistance, unless the vendor paid for the services provided to them [sic]." The 1998 bulletin concludes by stating that because of the "confusion about these in-store servicing provisions," no enforcement action would be taken against a vendor, distributor, or manufacturer for unauthorized services provided before the date of the bulletin. After the 1997 repeal of Florida Administrative Code Rule 61A-4.058, the main cause of confusion on the subject of in-store servicing of distilled spirits had been removed. However, the 1998 bulletin and any other efforts ABT made to inform and educate the regulated industry about its change of position were not completely successful. In-store servicing of distilled spirits by distributors continues to some extent today.5/ ABT does not dispute that the prohibition of in-store servicing of distilled spirits has general statewide application and that rulemaking on the subject is not infeasible or impractical. ABT's position is that the prohibition of in-store servicing of distilled spirits does not require a rule because the prohibition is established by statute.
Findings Of Fact Dr. Lawrence A. Hall is licensed by the Florida State Board of Dentistry and the Hearing Officer has jurisdiction over the Respondent and the offenses alleged. During the time periods alleged Respondent smoked marijuana in the office after office hours in company with employees including a 16-year-old employee. During the time periods alleged Respondent wrote numerous prescriptions in the names of employees for controlled substances or drugs to be used for his personal use or for the use of his wife or friends. These drugs consisted of Eskatrol, Dexadrine, Dexamyl, Percodan, and Quaalude and were taken by Hall during office hours while he was performing work on dental patients. Some of these drugs made Respondent nervous and irritable and adversely affected his practice of dentistry. During the period between March, 1974 and July, 1975 Hall habitually used controlled substances add drugs. On many occasions he would be late getting to the office for morning appointments and late returning from lunch for afternoon appointments. Occasionally he would fail to come to the office at all and scheduled appointments would have to be cancelled - usually after the patient had appeared for the appointment. Hall wrote prescriptions for his wife and for his employees for controlled substances and drugs for uses not related to the practice of dentistry. These drugs consisted of amphetamines, Quaalude, and Percodan, and were often picked up from the pharmacy by one of his office employees not named in the prescription. Hall knew that his federal narcotics license did not authorize him to write prescriptions for drugs not intended for use in the practice of dentistry. Amphetamines are listed as Class II controlled substances in Chapter 893 F.S. On one occasion, while treating a small child, Hall became exasperated, threw a syringe across the room, then ran out of the office to jog around the adjacent shopping center for about 15 minutes to regain his composure. On another occasion a patient reacted adversely to an anesthetic and was thereafter properly treated by Hall to restore her breathing to normal. The dental procedure for which the anesthetic was given was then performed satisfactorily. The patient involved remained a patient of Hall until she moved to a location too far away to continue to use Hall as her dentist. She was satisfied with the dental treatment received from Hall. Hall sought help in his personal and drug related problems from his minister. No evidence was presented that Hall performed unsatisfactory dental work. To the contrary, all evidence presented in this regard was to the effect that Hall's dental work was above average. At the time of the hearing and for some months prior thereto Hall was not taking drugs.
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.
The Issue Whether Respondents committed the offenses described in the Amended Administrative Complaints? If so, what disciplinary action should be taken against them?
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Department is a state government licensing and regulatory agency. Haro is now, and has been since April of 1980, a licensed pharmacist in the State of Florida. He holds license number PS 0017949. Rome is now, and has been since February of 1978, the holder of permit number PH 0007008, which authorizes it to operate La Generosa Pharmacy (hereinafter referred to as "La Generosa" or the "Pharmacy") as a community pharmacy in Dade County, Florida. At no time in the past has Rome, as the holder of permit number PH 0007008, been disciplined by the Board of Pharmacy. For the past eighteen years, Roger Diaz has been Rome's sole corporate shareholder and the owner of the Pharmacy. Haro was employed as the prescription department manager of La Generosa and its only pharmacist from approximately October 16, 1990, until some time after the dates of the alleged violations in these consolidated cases. He worked full-time (40 hours a week). Harold Gluck is an investigator with the Department. On December 4, 1990, at approximately 2:00 p.m., Gluck attempted to conduct a routine annual inspection of the Pharmacy, which had last been inspected 13 months previous. Upon entering the Pharmacy, Gluck found that there was no pharmacist on duty. Diaz was there, however. The lights in the prescription department were off and a "closed" sign was posted. A door to the prescription department, although closed, was unlocked. Gluck opened the door, walked in and turned on the lights. He saw Haro's license hanging on the wall. On the counter, he observed prescription vials containing pharmaceuticals. It appeared to Gluck that someone had been in the process of filling these vials and had been interrupted before completing the task. Gluck inquired of Diaz as to the whereabouts of the pharmacist. Diaz, in response to Gluck's inquiry, indicated that Haro had taken the day off to tend to some personal business. Gluck then asked Diaz who was filling the prescription vials "if the pharmacist isn't here." Diaz responded, "I don't know." Gluck continued his inspection. On the shelves in the prescription department he discovered a large number of expired drugs, some of which had expiration dates that predated the last inspection of the Pharmacy that had been conducted 13 months previous. None of the drugs that had been outdated for more than 13 months had been on the shelves during the last inspection. Gluck's inspection on December 4, 1990, also revealed prescription drugs in the Pharmacy outside of the prescription department. After cursorily examining the premises, Gluck left the Pharmacy. He told Diaz that he would be paying a return visit the following day to speak with Haro and to conduct a more thorough inspection. He warned Diaz not to enter the prescription department and asked him to lock the doors leading into that area of the Pharmacy. Diaz indicated that he would comply. Later that day at around 5:00 p.m., following Glucks's departure, Haro went to the Pharmacy "to observe how [it] was functioning." As he had promised, Gluck returned to the Pharmacy on December 5, 1990. He was accompanied by another of the Department's investigators, as well as three HRS drug inspectors. The prescription department was closed and Haro was nowhere to be seen. Diaz was present and Gluck asked him whether Haro had reported to work that day. Diaz told Gluck that Haro had again taken the day off to take care of a personal matter. Gluck tried to open the door he had used the day before to enter the prescription department, but it was locked and Diaz claimed not to know where to find a key to unlock the door. With Diaz's permission, Gluck and one of the HRS drug inspectors, Cesar Arias, walked into a back storage room that was adjacent the prescription department (hereinafter referred to as the "storage room") to ascertain if there was another entrance to the prescription department. There they spotted an unlocked door that led to the prescription department. After obtaining Diaz's authorization, they pushed the door open. In so doing, they moved an appliance, that had been behind the door, out of the way. They then walked into the prescription department. While in the prescription department, Gluck and Arias noticed a doorway that was covered, but not completely, by a piece of paneling. They removed the piece of paneling and then walked into the room (hereinafter referred to as the "hidden room"). The December 5, 1990, inspection of the Pharmacy revealed the following: Of the approximately 2,000 containers on the shelves in the prescription department, approximately 200 contained expired pharmaceuticals. Expired pharmaceuticals that Haro had removed from the shelves were in boxes in the storage room. There were containers of pharmaceuticals on the shelves in the prescription department that had labels which understated the quantity of pharmaceuticals in the container. There were containers of pharmaceuticals on the shelves in the prescription department that had labels which inaccurately described the strength of the pharmaceuticals in the container. On the shelves in the prescription department were containers of pharmaceuticals to which samples, that had been removed from their original packaging, had been added. According to records in the prescription department, prescriptions had been filled on December 4, 1990. Prescriptions for controlled substances that had been filled by Haro within the past month were lacking the date the prescription had been filled, the patient's name and address, the dispensing pharmacist's initials and/or the prescribing physician's DEA registration number. A bottle of Uropol, which Haro had for his own personal use, was in the prescription department. Uropol is a foreign drug that has not been approved for use in the United States. Vials containing prescription drugs that had been dispensed by Jorge's Pharmacy, another local pharmacy, were in the hidden room, as well as in bags, ready for customer pick-up, in the storage area. These vials had labels prepared by Jorge's Pharmacy. References to Jorge's Pharmacy's appear- ing on the labels, however, had been "whited out" so as to make it appear that Jorge's Pharmacy's was not the dispensing pharmacy. Furthermore, some of these vials contained lesser quantities of drugs than indicated on their labels. As Diaz candidly admitted to the inspection team during the inspection, Jorge's Pharmacy had filled these prescriptions pursuant to an arrangement that it had with Diaz. These were Medicaid prescriptions. Jorge's Pharmacy was a participant in the Medicaid program. La Generosa had been suspended from the program and therefore, unlike Jorge's Pharmacy, was not able to fill Medicaid prescriptions. Wanting to keep his Medicaid customers, Diaz had devised and implemented a scheme that allowed him to continue to do business with these customers. He had his Medicaid customers present their prescriptions to him or Blanca Uzman, one of his subordinates, at a counter outside of the store's prescription department (hereinafter referred to as the "outside counter"). The prescriptions were thereafter taken to Jorge's Pharmacy, where they were filled. The labeled vials containing the dispensed drugs were then delivered to La Generosa, where they were ultimately picked up, at the outside counter, but not before an effort had been made to obliterate, by using white-out, all references to Jorge's Pharmacy appearing on the vials' labels. Although Haro knew of this scheme, he was in no way involved in it. A prescription balance and prescription weights were in the hidden room. Neither a copy of the laws and rules governing the practice of pharmacy, a negative formulary, nor a biennial inventory record of controlled substances were located by the inspection team, although these items were on the premises. Following the December 5, 1990, inspection of La Generosa, administrative charges were brought against both Haro and Rome. Subsequent inspections of the Pharmacy established that "everything was in proper order."
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board, with respect to Case No. 91-6297, enter a final order finding Haro guilty of the violations alleged in Counts I, III, VIII, VIV, and XV of the Amended Complaint/Haro and disciplining him for having committed these violations by suspending his license for a period of 60 days, placing him on probation for a period of one year following the end of his suspension subject to such terms as the Board may specify, and requiring him to pay an administrative fine in the amount of $1,500.00, and, with respect to Case No. 92-0227, enter a final order finding Rome guilty of the violations alleged in Counts I, V, VII, IX, and XI of the Amended Complaint/Rome and disciplining it for having committed these violations by suspending its permit to operate La Generosa as a community pharmacy for a period of two years, placing it on probation for a period of one year following the end of its suspension subject to such terms as the Board may specify, and requiring it to pay an administrative fine in the amount of $2,500.00. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 27th day of September, 1993. STUART M. LERNER 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 27th day of September, 1993.
Findings Of Fact At all times relevant thereto, respondent, Manuel M. Maralit, held medical doctor license number ME 0033337 issued by petitioner, Department of Professional Regulation, Board of Medical Examiners. Maralit has been licensed as a medical doctor by the State of Florida since September 13, 1978. He has been a medical doctor since graduation from medical school in May, 1967. From January 1, 1983 through September 30, 1983, Maralit practiced medicine in Alachua County, Florida. During that period of time, he filed two unauthorized claims under the Florida Medicaid Program, each having an aggregate value of $200 or more in violation of Subsection 409.325(4)(a), Florida Statutes. He also received one unauthorized payment under the same program having an aggregate value of more than $200.00 in violation of Subsection 409.325(4)(c), Florida Statutes. After an information was filed by the State Attorney on December 13, 1983, Maralit pled guilty to the above three violations, and to a fourth charge of grand larceny. For this, he received twenty years probation, 2,000 hours of community service, a $15,000.00 fine to be paid within 12 months, and was required to make restitution of $2,398.51 to the Department of Health and Rehabilitative Services and $921.00 to the Florida National Bank. According to the official records of petitioner introduced into evidence, Dr. Maralit was subject to prior disciplinary action by the Medical Board in 1982 (DOAH Case No. 81-1367, Final Order entered January 4, 1982). At that time his license was suspended for thirty days, and was placed on probation for one year. The probationary period has long since expired. The violations in that proceeding are not similar in any respect to those charged in this case. There is no evidence as to any damage, physical or otherwise, to specific patients caused by respondent's conduct.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty as charged in Counts I and II of the administrative Complaint, and that his medical license be suspended for one year with six months' suspension stayed and his license be placed on three years probation. Count III should be dismissed. DONE and ORDERED this 4th day of December, 1985, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of December, 1985.
The Issue Whether petitioner should take disciplinary action against respondent for the reasons alleged in the administrative complaint?
Findings Of Fact At all pertinent times, respondent has held a Florida pharmacist's license, No. PS0017402, and has been president of American Chemist Shops, Inc., which holds permit No. PH0009600 to operate The Medicine Shoppe, a community pharmacy, at 488 NE 125th Street in North Miami, Florida. A second generation pharmacist, Mr. Ally trained in his native (British) Guyana and at the Chelsea School of Pharmacy in London, before qualifying as a pharmacist in England. He also worked at Rand Memorial Hospital in Freeport, Bahama Islands, before his initial licensure in Florida in 1979. After three years as a staff pharmacist at one Florida hospital and five and a half years as director of pharmacy at another, he went to work for Mrs. Friedman, a pharmacist's widow, then bought the pharmacy from her. Ever since he started at The Medicine Shoppe, respondent has been director of the pharmacy department. Even when Howard Friedmann was alive, Bonita Liston, a woman in her twenties, was a regular customer of The Medicine Shoppe. From time to time a Dr. Murray prescribed pain killers or antibiotics for her. The shop kept a file or card on Ms. Liston as it did on other regular customers. Ms. Liston's record reflected the filling of several prescriptions, but none after June 10, 1988, the date respondent's assistant made a note in the file which reads, "North Miami Detectives came in Shoppe, Do not disperse any Rx's." Hearing Officer's Exhibit No. 1. Nevertheless, on November 28, 1988, Mr. Ally gave Ms. Liston a brown two-ounce bottle full of Tussionex, a Schedule III "medicinal drug" containing hydrocodone. Coughing, she had arrived without a prescription shortly before the pharmacy closed that day. Dr. Murray had prescribed six-ounce supplies of this medicine for her on two occasions in September of 1987, and, respondent testified, she told him she would secure another such prescription the next day, return for four more ounces, and make payment. With Ms. Liston at the pharmacy on November 28, 1988, was Jodie Schuster, at the time an undercover policewoman working for the North Miami Police Department. Concealed on her person was a microphone or "body bug" which allowed special agent Jeffrey Michael Portz of the Florida Department of Law Enforcement to monitor conversations in the pharmacy. On December 7, 1988, respondent's 35th wedding anniversary, Ms. Schuster returned to the pharmacy similarly wired, and Mr. Portz resumed monitoring. She asked for more cough medicine for Ms. Liston, and respondent gave her two ounces of Hycodan, a drug not unlike Tussionex. Respondent's testimony that he did not also give her Valium tablets has been credited. Again no money changed hands, nor was any consideration offered or discussed. Taken from the pharmacy in handcuffs, respondent was criminally prosecuted and, on May 22, 1987, sentenced. Among other things, the sentencing judge suspended respondent's pharmacist's license effective that date. Petitioner reinstated the license on January 31, 1991, and renewed it shortly before hearing. Before his arrest, respondent and his assistant filled 80 to 120 prescriptions a day. In keeping with legal requirements, physicians prescribing controlled substances report the number assigned them by the federal Drug Enforcement Administration (DEA), by writing it or causing it to be written on the prescription form. Every such number is preceded by two letters, "A" followed by the first letter of the doctor's last name. Among the prescriptions for controlled substances filled by respondent or under his supervision at The Medicine Shoppe were some 30 which another pharmacist testified he would not have filled without verification. Two do not have patients' addresses. One prescription filled, Petitioner's Exhibit No. 1A, lacks a legible doctor's name, and has no DEA number. Another gives DEA number AH 224 3119 for a Dr. A. Carlos Casademont. Petitioner's Exhibit No. 6B. These irregularities notwithstanding, petitioner did not offer competent evidence to prove that any of the prescriptions were forged or invalid. An expert testified that good practice would have required verification, but was unable to say that respondent had in fact failed to verify the prescriptions. Petitioner did not allege or prove the absence of a written record (apart from the cancelled prescriptions themselves) of controlled substances, or prove the contents of any such records.
Recommendation It is, accordingly recommended: That petitioner suspend respondent's pharmacist's license for two (2) years, with credit for any suspension on account of delivery of Tussionex to Bonita Liston already accomplished. That petitioner suspend respondent's pharmacy permit for one (1) year, with credit for any suspension on account of delivery of Tussionex to Bonita Liston already accomplished. RECOMMENDED this 27th day of August, 1991, in Tallahassee, Florida. ROBERT T. BENTON, II 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 27th day of August, 1991. APPENDIX TO RECOMMENDED ORDER, CASE NO. 90-5809 With respect to petitioner's proposed finding of fact No. 1, the testimony was that the drug delivered to Ms. Schuster on December 7, 1988, resembled Tussionex but was not Tussionex. Petitioner's proposed finding of fact No. 2 is rejected as against the weight of the evidence. With respect to petitioner's proposed finding of fact No. 3, the evidence showed that certain prescriptions lacked the patient's address, the physician's DEA number or other detail, but petitioner's expert said it was acceptable practice to fill such prescriptions, if verified. Petitioner's proposed finding of fact No. 4 has been accepted at least as regards the Casademont prescription with DEA No. AH 224 3119. Petitioner's proposed finding of fact No. 5 is really a proposed conclusion of law. Respondent's proposed finding of fact No. 3, including subparts, has been adopted in substance, insofar as material, and to the extent reported in the findings of fact. Respondent's proposed findings of fact Nos. 4.1 through 4.4 are rejected as contrary to the weight of the evidence. Respondent's proposed findings of fact Nos. 4.5 through 4.9 and No. 5, including subparts, have been adopted, in substance, insofar as material. COPIES FURNISHED: John Taylor, Executive Director Board of Pharmacy Department of Professional Regulation 1940 N. Monroe Street Tallahassee, FL 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 N. Monroe Street Tallahassee, FL 32399-0792 Michael A. Mone, Esquire Department of Professional Regulation 1940 N. Monroe Street Tallahassee, FL 32399-0752 Neil F. Garfield, Esquire Garfield & Associates 3500 North State Road 7, Suite 333 Ft. Lauderdale, FL 33319
