The Issue The issue is whether Petitioner is entitled to a permit as a prescription drug wholesale distributor.
Findings Of Fact On August 29, 2007, Petitioner filed with Respondent an application for a permit as a prescription drug wholesaler establishment (Application). Pursuant to a change in the law effective July 1, 2008, this permit is now for a prescription drug wholesale distributor. The Application lists Boris Rios as the sole owner of Petitioner and its president and manager. The Application lists Alexander Valdes as the next highest-ranking employee with a title of certified designated representative (CDR). The Application requires Petitioner to list all persons who meet the following descriptions of affiliates: a) "a director, officer, trustee, partner, or committee member of a permittee or applicant or a subsidiary or service corporation of the permittee or applicant"; b) "a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless of whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant"; c) "a person who has filed or is required to file a personal information statement pursuant to s. 499.012(4), F.S., or is required to be identified in an application for a permit or to renew a permit pursuant to s. 499.012(3), F.S."; d) "the five largest natural shareholders who own at least 5 percent of the permittee or applicant . . ."; and e) "shareholder[s] owning 5% or more of the applicant." In response to this item, the Application states that Mr. Rios meets the criteria set forth in paragraphs a) through e), and Mr. Valdes meets the criteria set forth in paragraph b). Attached to the Application are Personal Information Statements for Mr. Rios and Mr. Valdes. Mr. Rios's Personal Information Statement discloses his employment, from July 2003 to July 2007, as a "sales mgr" with Worldwide Medical Supplies and Pharmaceuticals, Inc. (Worldwide). His statement includes a resume that states he was a "sales executive" for Worldwide from July 2003 to February 2004, a "purchasing/deliver[ies] manager" for Worldwide from February 2004 to May 2005, and a "sales manager" for Worldwide from May 2005 to July 2007. As sales manager, Mr. Rios stated that he "[o]ver looked all sales transactions for all sales reps (7 man sales force). Buy establishing sales strategies and product promotions to help increase our sales and profit margins. And keeping sales force motivated and inspired by creating incentives to reach goals." Mr. Rios's attached resume shows that he had been a sales manager for another pharmaceutical manufacturer from January 2001 to July 2003. Mr. Rios's statement also answers in the negative a question asking whether he, "or a company for which you were an owner, officer, director, or manager, has been fined or disciplined by a regulatory agency in any state (including Florida) for any offense that would constitute a violation of Chapter 499, Florida Statutes?" However, his statement answers in the affirmative a question asking whether he, "or a company for which you were an owner, officer, director, or manager, ever held a permit issued under Chapter 499, Florida Statutes, in a different name than [Petitioner's name]?" However, on a mostly blank page entitled, Additional Information," Mr. Rios handwrote that he was employed by Worldwide from July 2003 to July 2007 as the sales manager of seven salespersons from May 2005 to July 2007, as the purchasing manager from February 2004 to May 2005, and as a sales representative from July 2003 to February 2004. Mr. Valdes's Personal Information Statement discloses his employment with Worldwide from 2003 to present as a "sales mgr" and "D Rep," meaning certified designated representative. Inserted in the Application is a letter dated May 30, 2008, from Mr. Valdes to Rebecca Burnett, an employee of Respondent, stating that he was "hereby submit[ting] my resignation from Worldwide . . . effective May 30, 2008 " Mr. Valdes's Personal Information Statement contains a long typewritten statement that says he was employed at Worldwide since 2003 in "various positions," starting as a sales person, then a sales manager, and finally a CDR, following his preparing for and passing the certification test. At about the same time, a newer Worldwide employee, Rick Nielsen, also took the CDR test, passed, and became a CDR for Worldwide, working a different shift from Mr. Valdes. Mr. Valdes stated that he often ordered Worldwide not to accept or to return a product due to product-safety issues, and he helped state inspectors in their investigations concerning these matters. However, on the Personal Information Statement itself, Mr. Valdes answered in the negative a question whether he or any company for which he had been a manager had been fined or disciplined by a regulatory agency. By letter dated September 8, 2008 (Denial Letter), Respondent advised Petitioner of its intent to deny the application. Among the reasons cited for denial are that Petitioner listed Mr. Valdes as its CDR. The Denial Letter states that, in Final Order Number 08-1216, Respondent found 37 violations of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes, and revoked the permit of Worldwide Medical Supplies and Pharmaceuticals, Inc. (Worldwide), to operate as a prescription drug wholesale distributor. According to the Denial Letter, Mr. Valdes was Worldwide's CDR from August 2005 to May 2008 and sales manager from April 2003 to May 2008; he is also the son of the president and owner of Worldwide, Miriam Gonzalez. The Denial Letter states that Mr. Valdes was listed on the Application as a key employee of Worldwide and did not submit to Respondent his resignation as Worldwide's CDR until May 30, 2008. The Denial Letter asserts that, on four occasions from July 18 to November 8, 2005, Mr. Valdes received and authenticated a pedigree that was not authenticated, so that Worldwide failed to keep the required records of prescription drug transactions. The Denial Letter states that, on six occasions between October 17 and 31, 2005, Mr. Valdes or another Worldwide employee falsely represented under Mr. Valdes's signature that a pedigree had been presented to Worldwide and authenticated by Mr. Valdes, but Worldwide had not received the complete and accurate pedigrees and had not maintained them. The Denial Letter states that receipt of the drugs without a complete or accurate pedigree caused the drugs to be deemed adulterated. The Denial Letter states that, on August 16 and September 23, 2004; and September 25, October 16, and October 27, 2006, Worldwide purchased a prescription drug from an unlicensed manufacturer or wholesaler. The letter states that this activity constituted the purchase of contraband in commerce and was detrimental to the public health. The Denial Letter asserts that Mr. Rios was an affiliated party of Worldwide at all material times. The Denial Letter states that Mr. Rios owns Petitioner and provides financial support and assistance to Petitioner, so he is an affiliate of Petitioner. The Denial Letter states that Respondent found that Petitioner was not entitled to licensure under Section 499.012(4)(d)9, Florida Statutes. The Denial Letter states that, pursuant to Section 499.012(10)(b), Florida Statutes, Respondent may deny an application if it finds that the managers, officers, or directors of the applicant or an affiliate of the applicant are incompetent or untrustworthy. Based on the facts set forth above, Respondent finds Mr. Valdes, an affiliate, incompetent or untrustworthy. The Denial Letter states that, pursuant to Section 499.012(10)(g), Florida Statutes, Respondent may deny an application if it finds that the applicant is affiliated, directly or indirectly through ownership, control or other business relations, with any person or persons whose business operations are or have been detrimental to the public health. Based on the facts set forth above, Respondent finds Mr. Valdes is an affiliate whose prior business operations are or have been detrimental to the public health The Denial Letter states that, pursuant to Section 499.012(10)(r), Florida Statutes, Respondent may deny an application if it finds that the applicant or any affiliate has failed to comply with the requirements for manufacturing or distributing prescription drugs under Chapter 499, Florida Statutes. The Denial Letter asserts that Section 499.003(3), Florida Statutes, defines an affiliate to be a person who has filed or is required to file a personal information statement or a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant. The Denial Letter states that Respondent finds that Mr. Valdes, while employed at Worldwide, failed to comply with the laws related to the distribution of prescription drugs while having a duty to be actively involved in and aware of the actual daily operation of the company. The Denial Letter states that Mr. Valdes had a duty to be actively involved in and aware of the actual daily operations of the company. The Denial Letter states that, while Mr. Valdes was CDR for Worldwide, the company purchased prescription drugs from an unauthorized source, in violation of Section 499.005(16), Florida Statutes; failed to maintain records of prescription drug distributions as required by Florida Administrative Code Rule 64F-12.012(6) and (10), in violation of Section 499.005(18), Florida Statutes; accepted or maintained incomplete or nonexistent pedigrees and sold drugs to unlicensed persons, thus violating the adulterated-drug provisions of Section 499.005(1), (2), and (4), Florida Statutes. The Denial Letter states that, pursuant to Section 499.012(10)(m), Florida Statutes, Respondent may deny an application if the applicant or affiliate receives, directly or indirectly, financial support and assistance from a person who was an affiliate of a permittee whose permit was subject to discipline or suspended or revoked. The Denial Letter states that Petitioner receives financial support and assistance from Mr. Rios, who was an affiliate of Worldwide and is an affiliate of Petitioner. The Denial Letter states that, at all material times, Worldwide engaged in business operations that were detrimental to the public health by purchasing adulterated prescription drugs and by adulterating prescription drugs. Worldwide filed a renewal application on May 17, 2007, for a renewal term from July 1, 2007, to June 30, 2008. The renewal application lists Ms. Gonzalez as the company's sole shareholder and manager. The only persons listed among the next four highest-ranking employees are Mr. Valdes, who is listed as the CDR and "Longistic [sic] Manager" and Mr. Rios, who is listed as "Purch/Sales Director." Each man is reported as "a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee " Sometime in 2007, Respondent commenced a disciplinary proceeding against Worldwide. In its Second Amended Administrative Complaint dated August 24, 2007, Respondent alleged that Worldwide violated Sections 499.001 through 499.081, Florida Statutes, based on documents that it had prepared during 2004-06. A formal hearing took place on February 11 and 12, 2008, and Administrative Law Judge Patricia M. Hart entered a Recommended Order on May 1, 2008, which was adopted in its entirety by Final Order entered October 12, 2008 (FO). The Final Order finds Worldwide guilty of 37 violations of Chapter 499, Florida Statutes, imposes administrative fines of $185,000, and revokes Worldwide's permit as a Prescription Drug Wholesaler. The Final Order (FO) was never appealed. The FO finds multiple acts and omissions attributable to Worldwide in the handling of prescription drugs shipped to it or, in some cases, purchased by it. Concerning incomplete and thus fraudulent authentications of pedigree papers, these acts and omissions ranged from February to April, June to September, and December 2004; and April to November 2005. Only seven of these violations occurred in 2004; the rest were in 2005. Concerning purchases from unlawful persons, of which there were a dozen, these acts and omissions took place in August 2004, December 2004, June 2005 (two), April 2006, September 2006 (two purchases from Kuehne & Nagel) October 2006 (four purchases from Kuehne & Nagel), and March 2007. Mr. Valdes is named in connection with six of the unlawful transactions. For October 2005 (except for one transaction in November 2005, as indicated), the FO found a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 35 6GM vials of Carimune was incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of seven 10ML units of Baygam as incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 15 12GM vials of Carimune as incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 100 2ML units of Baygam was incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 100 units of Gammar P as incomplete and thus "false" (November 2005), and one pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of one 2ML unit of Baygam SDV and three 10CP units of Tamiflu 75MG was incomplete and thus "fraudulent." In his responses to requests for admission in this case, Mr. Valdes admits that he received and authenticated the pedigree paper, on October 10, 2005, for Carimune; the pedigree paper, on October 18, 2005, for Baygam; the pedigree paper, on July 18, 2005, for Baygam; and the pedigree paper, on November 8, 2005, for Gammar P. Worldwide never employed many employees, perhaps never more than 8-10. Ms. Gonzalez owned the company, but reduced her interest to 51 percent from February 2004 to December 31, 2006, during which period Mr. Nielsen owned 49 percent. However, Mr. Nielsen terminated his employment with Worldwide on December 31, 2006, and evidently relinquished his interest in the company at that time. Upon initial employment, Mr. Nielsen occupied a position in which he supervised the purchasing manager, Mr. Rios, who, even though called a manager, supervised no one. At that time, Mr. Rios was lower-ranking than Ms. Gonzalez, Mr. Nielsen, Mr. Valdes, and possibly another employee. At some point, Mr. Nielsen was designated a CDR for Worldwide, and he remained a CDR for Worldwide until he left employment with the company. Prior to that, Mr. Gonzalez had served as the CDR for Worldwide. Mr. Valdes also served as a CDR for Worldwide. Based on his responses to requests for admission, Mr. Valdes started as CDR for Worldwide in August 2005, so he and Mr. Nielsen were both CDRs for Worldwide at the same time. Mr. Valdes served until the end of July or early August 2006, when, dissatisfied with his employment situation, he terminated his employment. Mr. Valdes did not return until early January 2007 when his mother needed him to serve as CDR again because Mr. Nielsen had left, and no one remaining with Worldwide could pass the test to become a CDR. Mr. Valdes produced testimonials from various persons, such as a former drug agent supervisor of Respondent and current investigators of Medicaid fraud, who commend him for assisting in combating fraud in the wholesale pharmaceutical industry. However, at the hearing, Mr. Valdes never explained how he was not at fault or responsible for the violations in which the paperwork bore his stamp or other violations taking place, particularly while he was CDR. Mr. Valdes was sales manager during the 2004 violations and a CDR during all of the bad-pedigree transactions from August to December 2005, as well as one bad-purchase transaction in April 2006. He had sizable responsibilities during a timeframe that many violations were taking place at Worldwide, and, despite the three commendations and candid demeanor at the hearing, does not appear to have done a good job discharging these important duties. As confirmed by Ms. Gonzalez, Mr. Rios was the sales manager from May 2005 to July 2007, and he had supervisory authority over a sales staff that, at most, numbered seven persons. Mr. Rios could hire and fire salespersons, but he had no contact with the prescription drugs. From February 2004 to May 2005, Mr. Rios was purchasing manager, but worked under the supervision of Mr. Nielsen and lacked any managerial duties.
Recommendation It is RECOMMENDED that the Department of Health enter a final order denying the application for a permit as a prescription drug wholesale distributor until Mr. Rios substitutes a qualified CDR for Mr. Valdes--a condition that the Department of Health should allow Mr. Valdes a reasonable time to satisfy. If Mr. Rios cannot submit the name of a qualified CDR within such time, the final order should provide for the denial of the application without prejudice to refiling at a later date with a qualified CDR. DONE AND ENTERED this 9th day of March, 2009, in Tallahassee, Leon County, Florida. ROBERT E. MEALE 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 9th day of March, 2009. COPIES FURNISHED: Alexander Valdes, Qualified Representative 14052 Southwest 80th Street Miami, Florida 33183 Gary L. Asbell, Esquire Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 Rebecca Poston, R.Ph., Executive Director Drugs, Devices, and Cosmetics Program Department of Health 4052 Bald Cypress Way, BIN C04 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701
Findings Of Fact Respondent is Paula Kay Spears. She is a licensed registered nurse and holds license number 1435502. At all times pertinent to these proceedings, Respondent was employed as a registered nurse at Lakeland Regional Medical Center in Lakeland, Florida. Caren Hicks worked as a unit coordinator in the cardiovascular surgery unit of the hospital where Respondent was also employed as a registered nurse. Hicks and Respondent worked together for approximately five years. In April of 1988, Hicks witnessed Respondent using for the first time what Hicks believed to be a drug commonly called "crank". Hicks also used the substance on that occasion. Hicks purchased the substance from Respondent on only one later occasion; although she and Respondent engaged in joint use of the substance on several subsequent occasions. They ingested the substance by "snorting" it through the nose. Hicks provided crank on some occasions for the joint use of herself and Respondent. The two used the drug while on duty in the cardiovascular unit to which they were assigned. The last occasion of their joint usage of the drug was September 11, 1988. When she nasally inhaled the drug, Hicks observedthat her pulse rate and energy level increased. While she experienced fatigue when the effects of the drug wore off, Hicks never experienced any sense of confusion. She compared the effects of the substance to that of a drug commonly called "speed". Tommy Smith is the head nurse for the cardiovascular unit where Respondent and Hicks were employed in September of 1988. He confronted Respondent with the accusation that she and Hicks had used crank while on duty. Respondent denied the charge. Smith offered Respondent continued employment in her position, provided she submit to drug screening and rehabilitative treatment for drug abuse. Respondent rejected the offer. Subsequently, Respondent's employment with the hospital was terminated. Later, Smith made the same offer to Hicks. Hicks accepted the offer, attended a drug rehabilitation program and is still employed at the hospital. Expert testimony of Martin Zfaz, M.D., establishes that crank is a form of methamphetamine, a central nervous system stimulant which is regulated in accordance with Chapter 893, Florida Statutes, as a controlled substance and a schedule II drug. Crank, over a period of time, can cause confusion in the user's mental acuity. Depression follows use of the drug when its effects wear off. Usage can lead to dependence, with the possibility of resultant acute psychosis. Poor, impaired or confused judgement in the user can result. The substance is highly addictive, with limited medical use. Medical uses for crank include treatment for narcolepsy and hyper- activity in children. The substance is also prescribed as a balance to phenobarbital medication of epileptic patients. Although it depresses appetite, its usage for this purpose has decreased. Use of crank would have a negative effect on a medical nurse's judgement and performance.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered by the Board of Nursing finding Respondent in violation of Section 464.018(1)(i) and Section 464.018(1)(h), Florida Statutes. IT IS FURTHER RECOMMENDED that such Final Order suspend Respondent's license pending Respondent's completion of a drug dependency evaluation and provision by her of a report of that evaluation to the Board and demonstration to the Board that she is capable of safely practicing the profession of nursing. IT IS FURTHER RECOMMENDED that such Final Order place Respondent's license on probationary status for a period of three years upon satisfaction of the foregoing requirements for termination of license suspension with specific conditions of such probation to include periodic drug dependency reevaluations and reports as may be determined by the Board and payment of an administrative fine of $500. DONE AND ENTERED this 3rd day of November, 1989, in Tallahassee, Leon County, Florida. DON W.DAVIS 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 3rd day of November, 1989. APPENDIX TO RECOMMENDED ORDER The following constitutes my specific rulings, in accordance with Section 120.59, Florida Statutes, on findings of fact submitted by the parties. Petitioner's Proposed Findings. 1.-2. Accepted. 3. Weight of the evidence demonstrates that Respondent ingested the drug by "snorting" it. Finding rejected. 4.-14. Accepted 15. Rejected. Not consistent with the weight of the evidence. 16.-17. Rejected, unnecessary to result reached. Respondent's Proposed Findings. None submitted. COPIES FURNISHED: Michael A. Mon), Esq. Department of Professional Regulation The Northwood Centre, Suite 60 1940 N. Monroe St. Tallahassee, FL 32399-0750 Paula Kay Spears 1240 Sarasota Avenue Lakeland, FL 33805 Kenneth Easley, Esq. General Counsel Department of Professional Regulation The Northwood Centre, Suite 60 1940 N. Monroe St. Tallahassee, FL 32399-0750 Judie Ritter Executive Director Board of Nursing Department of Professional Regulation 504 Daniel Building 111 East Coastline Drive Jacksonville, FL 32201
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.
The Issue The issues posed for decision herein are whether or not the Respondent, Michael Hornstein, registered pharmacist, individually and as owner/operator of Rolette Drugs, Inc., d/b/a Curtiss Pharmacy, has engaged in conduct which will be set forth hereinafter in detail which warrants disciplinary action by the Board of Pharmacy. 1/
Findings Of Fact Based upon my observation of the witness and his demeanor while testifying, the arguments of counsel and the entire record compiled herein, the following relevant facts are found. Michael Hornstein is a registered pharmacist and is the owner/operator (licensee) of Rolette Drugs, Inc., d/b/a Curtiss Pharmacy. Pursuant to a Complaint and Notice to Show Cause filed December 20, 1979, 2/ against Respondent, individually and as owner/operator of Curtiss Pharmacy, the subject administrative hearing was convened to consider allegations that the Respondent, as alleged in the Complaint and Notice to Show Cause, permitted the keeping of improper records, in that he failed to maintain current and accurate records of scheduled controlled substances during the period January 1 through November 30. Pursuant to information furnished by the Drug Enforcement Administration (DEA) in Miami, Florida, a drug accountability audit was performed at Curtiss Pharmacy covering the period January 1 through November 30. The subject audit covered the controlled drugs, Quaalude, Dilaudid, Biphetamine, Tuinal and Desoxyn. Vernon K. Bell, the investigative supervisor for Region V investigative services (Miami, Florida), conducted the drug accountability audit of Curtiss Pharmacy by conducting an on-site review and reconciliation of Respondent's scheduled drug purchases and prescription files respecting the subject drugs. Investigator Bell started the audit period with a beginning inventory for the subject drugs of zero, making no allowances for drugs the Respondent had on hand on January 1. Investigator Bell also allowed Respondent a credit for those scheduled drugs claimed to have been lost due to thefts and robberies. Respondent introduced records which revealed that as a result of robberies of the pharmacy on February 5 and September 26, approximately two hundred (200) Biphetamine capsules and three hundred (300) Quaalude tablets were taken. Examination of the drug accountability report reveals that during the audit period, from total purchases of approximately ten thousand six hundred (10,600) Quaalude 300 mg tablets, Respondent was short approximately eight thousand six hundred nine (8,609) tablets when the drug report was completed for the audit period on December 7 by Investigator Bell. For the scheduled drug, Dilaudid four mg tablets, of total purchases of one thousand four hundred (1,400) tablets, Respondent was short one thousand two hundred eighty (1,280) tablets as of the audit period ending November 30. Biphetamine 20 mg capsules were short approximately one thousand six hundred fourteen (1,614) tablets from total purchases of two thousand three hundred (2,300) tablets during the audit period. Allowing for adjustments, there is still an outstanding shortage of approximately one thousand three hundred fourteen (1,314) Biphetamine capsules. Of total purchases of two thousand (2,000) Tuinal three gram capsules, Respondent's records revealed a shortage of approximately one thousand eight hundred sixty-four (1,864) capsules. Finally, of seven hundred (700) Desoxyn 15 mg tablets, Respondent's records reflect a shortage of six hundred forty (640) tablets. (Petitioner's Exhibit 1 and testimony of Vernon K. Bell.) 3/ RESPONDENT'S DEFENSE Respondent introduced exhibits which substantiated that Respondent's pharmacy was robbed on at least two occasions and police incident reports were completed, as well as DEA controlled drug loss forms to substantiate Respondent's claimed loss for the subject drugs, Biphetamine and Quaalude. Allowances were made herein for the claimed losses. (Respondent's Composite Exhibits 1 through 5.) Thereafter, Respondent invoked the Fifth Amendment privilege based on the claimed pendency of other criminal litigation. Respondent also allowed that the instant administrative proceedings herein should have been abated based on the pending or imminent criminal proceedings involving the subject drug losses by DEA. Respondent requested leave to supplement the record at such time as immunity is granted or jeopardy is removed when the related criminal proceedings have been terminated. This request was considered and denied based on the undersigned's conclusion that the Petitioner is authorized and is in fact duty bound to proceed as the regulating agency charged with protecting the public. See Schwartz v. Florida Board of Pharmacy, 302 So.2d 423 (1DCA 1974), cert. denied, 314 So.2d 151 (,Fla. 1975). Finally, Respondent questioned the accuracy of the audit based on the adjustments made when the police incident and DEA 106 forms were presented. Respondent also claimed that there was a possibility that there should be an additional downward adjustment of approximately nine hundred (900) Quaalude tablets. 4/
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Respondent's license to practice pharmacy and permit to operate a pharmacy in this State be SUSPENDED FOR A PERIOD OF TWO (2) YEARS. RECOMMENDED this 16th day of July, 1980, in Tallahassee, Florida. JAMES E. BRADWELL, Hearing Officer Division of Administrative Hearings 101 Collins Building Tallahassee, Florida 32301 (904) 488-9675
Findings Of Fact The Respondent, Deborah Sanchez Nelson, L.P.N., admits that on or about February 23, 1978, on the sixth floor of Palmetto General Hospital, Hialeah, Florida, several ampules of a controlled drug, to wit: Demerol (Meperedine) Injectable, were discovered to have been tampered with in that the fluid levels were not uniform as is true of untampered ampules. The Respondent was assigned to medications on the sixth floor of said hospital and was questioned concerning the incident and admitted to having taken said narcotic. A search of the Respondent's purse by an officer of the Hialeah Police Department revealed a vial labeled as water, containing approximately 12 cc of clear liquid, which upon being chemically analyzed proved to be Meperedine. Deborah Sanchez Nelson had worked at Palmetto General Hospital from February 10, 1978, until the incidents described above on February 23, 1978. Nelson has voluntarily not worked as a licensed practical nurse since that date and is currently employed at J. C. Penny's as a salesperson. Freda Drees, Director of Nursing at Palmetto General Hospital, first met Nelson upon her employment on February 10, 1978. Drees observed Nelson during the hospital's orientation program and later after she assumed her duties with the hospital. Drees described Nelson as a good nurse. Mitchell M. Ross, Director of Pharmacy, Palmetto General Hospital, testified that he had known Nelson for approximately four years, having first met her while employed as a pharmacist at Parkway General Hospital. Nelson was employed at Parkway General Hospital serving on the night shift. Ross had occasion to observe Nelson and stated that she was very good with patients. Ross stated that there had never been any trouble with Nelson at Parkway General Hospital involving drugs and that because of his position with the hospital he would have been aware of any discrepancies or violations. Dorothy Ware, State Probation Officer, Department of Corrections, testified that she had known Nelson since July, 1978, when Nelson was assigned to her as a probationer. Nelson had been placed on probation by the Broward County Court as a result of her conviction for leaving the scene of an accident which occurred on approximately February 28, 1978. Ware stated that Nelson admitted her drug involvement to her during their initial interview and sought assistance from Ware in dealing with her drug problem. Nelson was referred by Ware to a drug rehabilitation program and immediately contacted this program. However, testing by the program revealed that Nelson was not using drugs, and she was not placed in the program. Ware stated that Nelson was very responsible, had met all obligations of her probation to include paying the cost of her probation as directed by the court. Ware stated that Nelson was very remorseful about her drug involvement and having taken drugs from the hospital. Ware recommended that no action be taken that would deny Nelson her right to practice practical nursing. Deborah Sanchez Nelson testified on her own behalf and admitted she had been involved with drugs for eight months. She stated that her involvement arose when she became personally involved with an individual who was involved with drugs and started using drugs herself. The drug of use was Demerol, which her friend was supplying. She stated that she had not admitted to herself that she was addicted and needed drugs until the incident at Palmetto General Hospital. At that time she had broken off her relationship with the person with whom she was involved and who was supplying her with the drug, Demerol. Nelson stated that the accident which had led to her conviction for leaving the scene of an accident had occurred because she was distraught over her theft of drugs from the hospital, the termination from her job, and the realization that she was addicted to drugs. After the accident, Nelson was admitted by a psychiatrist to the hospital for treatment. Nelson stated her involvement with drugs was over and that she had a better self-image of herself. Her testimony concerning her no longer being involved with drugs was confirmed by Ware's testimony that the study done of Nelson by the drug referral service revealed that Nelson was not using drugs. Nelson stated that she missed nursing, desired to continue practicing nursing, and would submit to any conditions established by the Board if permitted to continue in nursing.
Recommendation The admissions of the Respondent clearly establish that she violated the provisions of law cited above. The testimony in mitigation establishes that the Respondent was, prior to her involvement with drugs, a fine nurse who was good with patients. The Respondent's involvement with drugs arose out of a personal involvement with an individual who was also involved with drugs and supplied the Respondent with Demerol, which was the drug of abuse. The Respondent testified that she had not admitted to herself her addiction until her supply of Demerol was cut off, when her personal relationship with the individual supplying her was terminated. Nelson has sought professional treatment for her personal and drug problems, overcoming her drug addiction and apparently the personal problems which gave rise to it. She has voluntarily not practiced nursing for approximately one year. The Director of Nursing for Palmetto General Hospital and the Director of the Pharmacy at Palmetto General Hospital both voluntarily testified in her behalf. Her probation officer voluntarily appeared and confirmed that Nelson was no longer involved in drugs, was deeply remorseful over her involvement with drugs and stealing drugs from the hospital, and had responsibly met all of the terms of her probation for conviction of an unrelated offense. Her probation officer specifically recommended that no action be taken to deny Nelson the opportunity to practice nursing. Nelson testified and exhibited remorse and concern over her actions, freely admitted her addiction, and stated that she had overcome her drug problem and personal problems and turned her life around. She stated that she missed nursing and desired to return to nursing. The use of drugs by a nurse is one of the most serious violations of Chapter 464 because of the access available to medical personnel and because they must be mentally and physically capable of attending patients whose lives and well-being are entrusted to them. If possible, the theft of drugs from patients, or the adulteration of drugs for patients' use, is more serious because it affects the strength of the drugs administered and subjects the patient receiving them to pain and suffering. However, addiction is a powerful thing, and it overcomes the natural inclinations and professional training one has received. Unquestionably, those guilty of such violations should be appropriately disciplined. Generally, in a case involving patients' drugs a suspension of no less than two years would be recommended. However, in this instance the Respondent voluntarily removed herself from nursing nearly one year ago, which should be considered in determining the final penalty. Also, her own efforts and success in overcoming her personal problems and addiction must be considered. Based on the foregoing Findings of Fact Conclusions of Law and Facts in Mitigation, the Hearing Officer would recommend that the Board suspend the license of the Respondent for 24 months, give credit to the Respondent for the 12 months she has voluntarily not practiced, and suspend the last six months of the remaining 12 months, permitting the Respondent to return to practice under conditions established by the Board in order that the Board may maintain closer supervision over the Respondent during her initial return to practice. DONE and ORDERED this 27th day of February, 1979, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Julius Finegold, Esquire 1007 Blackstone Building Jacksonville, Florida 32202 Geraldine B. Johnson State Board of Nursing 6501 Arlington Expressway, Bldg B Jacksonville, Florida 32211 Deborah Sanchez Nelson 19414 NW 30th Court Miami, Florida 33162 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE FLORIDA STATE BOARD OF NURSING IN THE MATTER OF: Deborah Sanchez Nelson As a Registered Nurse Case No. 78-2056 19414 N. W. 30th Court License Number 32957-1 Miami, Florida 33162 /
The Issue The issue is whether the Petitioner, Harvey Donley, is liable for the jeopardy assessment as set forth in the Revised Notice of Assessment and Jeopardy Findings dated August 6, 1990.
Findings Of Fact On June 9, 1989, Petitioner sold a quantity of cocaine to a confidential informant at Albertson's Food Store on Apalachee Parkway, Tallahassee, Florida. On June 9, 1989, Petitioner drove to Albertson's Food Store, parked his car, and got into the confidential informant's vehicle. Shortly after Petitioner had entered the confidential informant's vehicle and conducted a transaction of cocaine, he was arrested. At the time of Petitioner's arrest, one plastic bag containing cocaine was recovered from the seat next to where Petitioner had been seated. A second bag of cocaine was recovered from Petitioner's shirt. After Petitioner's arrest, Petitioner told Sgt. McKissack that he got the cocaine from one Paul Dorlag. Petitioner further told Sgt. McKissack that the bag of cocaine in his shirt pocket was his "cut" of the cocaine. After Petitioner's arrest, police officers executed a search warrant at Petitioner's residence. During the search, under the search warrant, a small quantity of paraphernalia and drug residue were seized in Petitioner's home. This paraphernalia consisted of a plastic cocaine straw. Other evidence seized during the search of Petitioner's residence consisted of a cedar box containing cannabis residue and one bottle of Insitol. After his arrest, Petitioner was charged with trafficking in cocaine. Twenty-five and one-half (25.5) grams of cocaine were recovered from Petitioner's person when he was arrested. The estimated retail price of the cocaine seized from Petitioner was $100 per gram. The estimated retail value of the total amount of cocaine seized from Petitioner amounted to $2,550. The Revised Notice of Assessment and Jeopardy Findings dated August 6, 1990, is legally valid and mathematically correct. The 50% tax according to the revised assessment is $1,275. The 25% surcharge according to the revised assessment is $637.50. The penalty of 5% per month according to the revised assessment is $95.63. Interest accrued through August 2, 1990, amounts to $238.14. The total amount of the legal assessment against Petitioner is $2,246.27. The additional interest for the period from August 2, 1990, to the date of the hearing, January 31, 1991, amounts to $114.66. Interest continues to accrue until the assessment is paid. The total assessment due through January 31, 1991, is $2,360.93.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Department of Revenue enter a Final Order upholding the revised assessment in the amount of $2,360.93, plus additional interest as shall become due after the date of the hearing. RECOMMENDED this 13th day of March, 1991, in Tallahassee, Florida. DIANE K. KIESLING 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 13th day of March, 1991. APPENDIX TO RECOMMENDED ORDER, CASE NO. 90-2734 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on the proposed findings of fact submitted in this case. Specific Rulings on Proposed Findings of Fact Submitted by Respondent, Department of Revenue 1. Each of the following proposed findings of fact is adopted in substance as modified in the Recommended Order. The number in parentheses is the Finding of Fact which so adopts the proposed finding of fact: 1-20(1-20) and 21(16). COPIES FURNISHED: Lee R. Rohe Assistant Attorney General Tax Section, Capitol Building Tallahassee, Florida 32399-1050 Harvey Donley 4918-B Crawfordville Road Tallahassee, Florida 32304 J. Thomas Herndon Executive Director Department of Revenue 104 Carlton Building Tallahassee, FL 32399-0100 Vicki Weber General Counsel Department of Revenue 204 Carlton Building Tallahassee, FL 32399-0100
The Issue Whether the Petitioner is entitled to fees as a prevailing small business party pursuant to Section 57.111, Florida Statutes.
Findings Of Fact The Respondent is the state agency charged with the authority to oversee and govern the Medicaid Program in Florida. To that end the Agency has established a Medicaid Program Integrity Bureau that seeks to detect and prevent fraud and abuse by Medicaid providers. The Petitioner is a pharmacy provider within the purview of the Florida Medicaid Program. As such, it is accountable to the Agency for its accounting practices and records. At all times material to the underlying case in this matter (DOAH Case No. 00-4708) the Agency employed auditors who routinely review the records of Medicaid providers being reimbursed through the Medicaid Program. In DOAH Case No. 00-4708 such auditors determined that the records maintained by the Petitioner did not accurately reflect information needed to verify and support the billings for which the Medicaid Program had reimbursed the Petitioner. In one instance, the Petitioner did not produce authorizations for a substitution of a prescribed drug. In a separate claim, the Agency maintained that the records indicated an invoice shortage for a prescribed medication. In other words, the provider had allegedly billed for a certain amount of drugs but the acquisition records and invoice records did not establish that quantities in a corresponding amount had been purchased for dispensing. The Agency hired Heritage Information Systems to perform an independent audit of the Petitioner. That audit supported findings unfavorable to the Petitioner in that it identified a substitution problem. The substitution of a more expensive drug for a less expensive prescribed drug is not permissible under the Medicaid Program guidelines without authority from the prescribing physician. As it relates to this case, the prescribing physician was Dr. Sachs. Coincidentally, Dr. Sachs owns the Petitioner. At all times material to the auditing period, the Agency interviewed Dr. Sachs, reviewed all records provided to it at the Petitioner's office, and believed that Dr. Sachs had not authorized the substitution of the more expensive drug for the drug prescribed. Thus, when the records indicated the Petitioner had substituted and billed Medicaid for the more expensive drug, a substitution issue was documented. This claim formed the basis for DOAH Case No. 00-4708. Dr. Sachs appeared before the auditors on more than one occasion and did not indicate that he had authorized any substitution for the prescribed item. At all meetings with Dr. Sachs the Agency believed that the doctor had written prescriptions for IVIg. In fact, Dr. Sachs wrote prescriptions for IVIg, Dr. Sachs did not write prescriptions for CytoGam. As to all prescriptions written for IVIg, the Medicaid Program was billed for a drug known as CytoGam. The substitution of CytoGam for IVIg formed the crux of the auditing dispute. Based upon the substitution issue, the Agency elected to attempt recovery against the Petitioner for the unauthorized substitution of the more expensive drug. Not once during the auditing process did the Petitioner or Dr. Sachs allege that the substitution had been authorized. No records were produced during the audit to support the substitution. Nevertheless, in anticipation of trial and within a short time before hearing on the underlying case, the Petitioner produced documents that supported the Petitioner's claim that Dr. Sachs had authorized the substitution. This assertion was directly opposite of the position formerly held by the doctor. Moreover, given the short time remaining until hearing, the Agency had no opportunity to verify the authenticity of the exculpatory documents. Rather than proceed to hearing on the unauthorized substitution claim, the Agency filed a Motion to Relinquish Jurisdiction based upon its decision to rescind the action against the Petitioner. Such motion was treated as a voluntary dismissal. Subsequently, the hearing was canceled and the Division of Administrative Hearings relinquished jurisdiction to the Agency. A final order was entered by the Agency on July 19, 2001. The Agency has not contested the timeliness of the Petitioner's claim for fees and costs pursuant to Section 57.111, Florida Statutes. The Agency does not dispute that the Petitioner is a small business as defined by Section 57.111, Florida Statutes. The Agency maintains its actions were substantially justified in the underlying case and that the Petitioner is not a prevailing party as a matter of law. The Petitioner argues that had the Agency done its job of auditing more thoroughly the actions against the Petitioner would have been avoided. As such, the Petitioner maintains it is entitled to recover fees and costs in the amount of $15,000. The Agency does not dispute that the Petitioner incurred fees and costs in excess of the statutory cap in defense of the underlying case. One of the complicating factors in the case was the issue of whether CytoGam was a permissible substitution to fill a prescription written for IVIg. The issue of permissible substitution then was clouded by the fact that until preparations for hearing were being finalized the Agency did not know that Dr. Sachs had authorized the substitution. Presumably, had there been no authorizations, the question of permissible substitution of the drugs would have been the focus for trial. Once the exculpatory documents were produced by the Petitioner, the Agency's theory of the case was left questionable. Permissible or not, the doctor had authorized the substitution. Because the Petitioner had dispensed the drug billed to the Medicaid Program, the billing of the substituted more expensive drug would have been authorized. Additionally, had Dr. Sachs written prescriptions for CytoGam, the auditing process would have supported the records initially produced by the Petitioner.
The Issue The central issue in this case is whether the jeopardy assessment filed by the Department against Petitioner should be affirmed.
Findings Of Fact Based upon the testimony of the witnesses and the documentary evidence received at the hearing, I make the following findings of fact: The petitioner, Albert Charles Harris, is also known as Bert or Albert Harris. During the month of July, 1986, Petitioner was employed to copilot a flight from Florida to Colombia and to return to an airstrip located near Lakeland, Florida. The private flight was arranged for the purpose of bringing 460 kilograms of cocaine into the State of Florida. The airplane was owned by a drug importation organization that arranged transportation for drugs from Colombia to the United States. Cocaine is a controlled substance enumerated in Section 893.03, Florida Statutes. Richard Bahmann was employed as the pilot for the July flight in which Petitioner participated. Frank Bahmann was also employed to fly a cover plane for the aircraft piloted by Richard Bahmann and Petitioner. The "mission" of the Bahmanns and Petitioner was to assure the safe delivery of cocaine from its owners in Colombia to its owners in Florida. Petitioner did not own the substance transported. Petitioner's employers did not own the substance transported. Petitioner and the others were to be paid based upon the volume of cocaine they were able to transport to Florida. Petitioner participated in the transportation of 460 kilograms of cocaine from Colombia to Florida in July, 1986. The street value of cocaine in the Miami area in July, 1986 was $35,000/kilo. The amounts owed to the Bahmanns and Petitioner for their participation in the transportation was $330,000. There is no evidence as to what amount Petitioner's employers were paid for their part in the transportation.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That the tax warrant and jeopardy assessment filed against Albert Charles Harris be affirmed. DONE and RECOMMENDED this 30th day of August, 1988, in Tallahassee, Florida. JOYOUS D. PARRISH 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 30th day of August, 1988. COPIES FURNISHED: Douglas Stratton 505 Lincoln Road Miami Beach, Florida 33139 William Watson and Jeffrey Dikman Department of Legal Affairs Tax Section, Capitol Building Tallahassee, Florida 32399-1050 Sam D. Alexander Executive Director 102 Carlton Building Tallahassee, Florida 32399-0100 William D. Townsend General Counsel 104 Carlton Building Tallahassee, Florida 32399-0100 =================================================================
