Findings Of Fact Based upon my observation of the witnesses, their demeanor while testifying, the documentary evidence received and the entire record compiled herein, I make the following findings of fact: The Department of Health and Rehabilitative Services (??"HRS") is the regulatory agency charged with the administration of Chapter 499, Florida Statutes, which includes the issuance of permits to operate a drug wholesale facility. Sometime prior to December, 1986, Petitioner, Vetco International, Inc. d/b/a Pompano Vet Supply ("Vetco") was issued Wholesale Drug Permit Number 03:00375 by the Pharmacy Program of HRS. On December 15, 1986, HRS received an application from Thomas Karpinski, owner of Vetco, to renew Vetco's drug wholesale permit for 1987. On December 17, 1986, HRS denied Vetco's application for renewal of its wholesale drug permit for the year 1987. Vetco requested a formal administrative hearing on the denial and the matter was referred to the Division of Administrative Hearings where it was assigned Case No. 87-0832. A hearing was held in that case on August 18, 1987 by Hearing Officer, James Bradwell of the Division of Administrative Hearings. On March 28, 1988, Hearing Officer Bradwell entered a Recommended Order recommending that Vetco's renewal application for the year 1987 be denied. The basis for that recommendation was that the applicable statutes and rules required that facilities where drugs are held be made available for inspection; that on several occasions Vetco's facility was not made available to authorized agents of HRS for inspection; and that Vetco's denial of inspections to HRS constituted a substantial violation of Chapter 499, Florida Statutes and Rule 10D-45, Florida Administrative Code. Hearing Officer Bradwell's Recommended Order was approved and incorporated in a Final Order by HRS dated April 20, 1988. On May 16, 1988, Vetco filed a Notice of Administrative Appeal to the Fourth District Court of Appeal regarding the Final Order issued by HRS on April 20, 1988. The case number assigned by the District Court of Appeal was Case No. 88-1342. On June 23, 1988, Vetco filed a Motion for Imposition of Automatic Stay with the Fourth District Court of Appeal seeking to stay the effect of HRS' April 20, 1988 Final Order. The Motion to Stay was granted by the Fourth District Court of Appeal on July 15, 1988. On December 28, 1988, the Fourth District Court of Appeal, per curiam, affirmed HRS' April 20, 1988 Final Order. The Mandate from the Fourth District Court of Appeal was issued on January 13, 1989. During the time period between the conclusion of the formal administrative hearing in August, 1987 and the issuance of the Recommended Order by Hearing Officer Bradwell in March, 1988, counsel for Vetco initiated efforts to obtain a renewal of the drug wholesale permit for the year 1988. Vetco contends that it did not receive the standard 1988 renewal application form typically sent by HRS prior to the beginning of the new year. By letter dated January 21, 1988, counsel for Vetco advised HRS that Vetco intended to keep its license in effect. In that letter, counsel for Vetco submitted a check for the amount of the renewal fee and provided certain other information required as part of the renewal process. During the period from January, 1988 through May, 1988, there were several exchanges between counsel for Vetco and the representatives of HRS regarding the renewal for the year 1988. HRS took the position that the January 21, 1988 letter from counsel for Vetco could not serve as a renewal application because it was not signed by the owner of the company and was not submitted on the appropriate HRS form. Vetco contends that the January 21, 1988 letter included all of the information legally required to process the renewal application and should have been treated as a renewal application. After exchanging correspondence and phone calls with counsel for Vetco and obtaining a signed form from Vetco, HRS acknowledged on May 24, 1988, that the renewal application was complete. On June 6, 1988, HRS denied Vetco's application for license renewal for the year 1988 citing the Final Order filed on April 20, 1988 and the Findings of Fact set forth in the Recommended Order entered by Hearing Officer Bradwell on March 28, 1988 in connection with the 1987 renewal application. By petition filed June 30, 1988, Vetco sought a formal hearing on the denial of its 1988 renewal application. The matter was referred to the Division of Administrative Hearings and assigned Case No. 88-3596. It is one of the two cases consolidated in the current proceeding. As noted above, by order dated July 13, 1988, the Fourth District Court of Appeal stayed the effect of the Final Order regarding the 1987 renewal application and, by agreement of the parties, Division of Administrative Hearings Case No. 88-3596 was abated pending the decision of the Fourth District Court of Appeal on the 1987 renewal. Thus, Vetco was able to continue business operations uninterrupted throughout 1987 and 1988. On January 6, 1989, Vetco applied for renewal of its drug wholesale permit for the year 1989. By letter dated January 17, 1989, HRS refused to renew Vetco's permit for 1989 citing the Fourth District Court Of Appeal's decision on the 1987 application. On February 2, 1989, Vetco filed a Petition for Formal Hearing challenging this denial. The Petition for Formal Hearing was transferred to the Division of Administrative Hearings and assigned Case No. 89-717. It is the second case involved in this current proceeding. By order dated April 19, 1989, Division of Administrative Hearings' Case Nos. 88-3596 and 89-717 were consolidated.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is: RECOMMENDED: Petitioner's application for renewal of its wholesale drug permit No. 03:00375 for the year 1988 be dismissed as moot and the application for renewal for the year 1989 be DENIED. DONE and ENTERED in Tallahassee, Leon County, Florida, this 23rd day of August, 1989. J. STEPHEN MENTON 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 23th day of August, 1989. APPENDIX TO RECOMMENDED ORDER, CASE NOs. 88-3596 AND 89-0717 The parties have submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. The Petitioner's Proposed Findings of Fact Proposed Finding Paragraph Number in Recommended Order of Fact Number Findings of Fact where accepted or reason for rejection 1 2-7 2-12 Adopted in part in Findings of Fact 13-16, otherwise rejected as irrelevant. 13 Adopted in part in Findings of Fact 17, otherwise rejected as irrelevant. 14 Rejected as irrelevant. 15 Adopted in part in Findings of Fact 18-19, otherwise rejected as irrelevant. 16 Adopted in part in Findings of Fact 9-12 and 20, otherwise rejected as irrelevant. 17-21 Rejected as irrelevant. The Respondent's Proposed Findings of Fact The proposed findings of fact in Respondent's Proposed Recommended Order are not numbered. The individual paragraphs are treated as though separately numbered. Proposed Finding Paragraph Number in Recommended Order of Fact Paragraph Findings of Fact where accepted Number reason for rejection 1 3 2 Adopted in part in Findings of Fact 4, otherwise rejected as irrelevant. 3 Adopted in part in Findings of Fact 5, otherwise rejected as irrelevant. 4 6 5 6-7 6 8-12 COPIES FURNISHED: Karen Coolman Amlong, Esquire Amlong & Amlong, P.A. 101 N.E. 3rd Avenue 2nd Fl. Fort Lauderdale, Florida 33301 John Rodriguez, Esquire Technical Health Services, Department of Health and Rehabilitative Services 1317 Winewood Boulevard Building 1, Room 304 Tallahassee, Florida 32399-070 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 John Miller Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
Findings Of Fact Respondent holds community pharmacy license No. PH0007711, renewed January 13, 1983. On May 21, 1981, Lester J. Henderson signed a new establishment permit application as owner, officer, manager and registered pharmacist. On June 9, 1981, petitioner conducted a new establishment inspection of Tampa Park Plaza Pharmacy. On June 19, 1981, Mr. Henderson wrote that "Andrew Mobley is no longer the Pharmacy Manager of Tampa Park Plaza Pharmacy, but I am . . . ." Petitioner's Exhibit No. 1. Petitioner received this notification on June 24, 1981, and, on the following day, wrote Mr. Henderson "to advise that effective as of June 19, 1981, our records were amended to reflect that you are the pharmacist manager." MBHS Corp., Inc. (MBHS), owns Tampa Park Plaza Pharmacy, (the pharmacy) and MBHS is owned in turn by its three officers. MBHS' president, Andrew Mobley, and Lester Henderson, an MBHS vice-president, are registered pharmacists. Samuel Snowden, also an MBHS vice-president and the third stockholder, is not a pharmacist. After the pharmacy opened for business, Andrew Mobley left Florida, and left the every day operation of the pharmacy to Lester Henderson, whom he knew to have had no retail experience as a pharmacist. In December of 1981, Mr. Mobley returned from Oklahoma to find a complete dearth of pharmaceutical records. Mr. Henderson explained that he did not like paperwork. Mr. Mobley returned to Oklahoma, again leaving the every day operation of the pharmacy to Mr. Henderson, but returned to Tampa when a bank that had made the pharmacy a loan threatened to call it in. He found scheduled drugs mixed in together, with unscheduled drugs, and a continued lack of records. Mr. Mobley then set up an inventory control book, something that had been neglected to that point. It developed that some Dilaudid was missing, which seemed to be news to Mr. Henderson. Mr. Mobley told Mr. Henderson the fact that the drugs were missing would have to be reported to the Department of Professional Regulation and Mr. Mobley got forms from the Department of Professional Regulation's office on Henderson Boulevard, which he gave to Mr. Henderson to fill out. Mr. Henderson never did fill them out and reportedly said "Andrew . . . must be crazy if he thinks I'm going to fill out those papers and send them in to those people." (T. 35) Mr. Mobley worked with Mr. Henderson in an effort to straighten out record keeping at the pharmacy, but also took a job at Walgreen's beginning in February of 1983. He left this job in June to take over from Mr. Henderson as pharmacy manager at the pharmacy. Mr. Henderson has not been employed at the pharmacy since. Edward G. Bludworth and Merry L. Paige, investigators in petitioner's employ, visited the pharmacy about ten o'clock on February 16, 1983. The prescription department was open; it was unlocked and there was no "closed" sign, but there was no pharmacist on duty. When the investigators asked to speak to the pharmacist, the store clerk made several telephone calls. She was only able to locate Mr. Henderson at about two o'clock, after the investigators had left. Mr. Bludworth and Ms. Paige conducted an audit of scheduled drugs at the pharmacy on February 16, 1983. Because of the lack of an inventory report as of the spring of 1981, they assumed no drugs on hand as of June 9, 1981. On this assumption they concluded that 296 tablets of Dilaudid 2 mg. were missing and unaccounted for. Dilaudid contains dihy dromorphinone [sic]. On the same assumption, they found a shortage of 41 Percodan tablets, which contain oxycodone, and an overage of 97 Demerol tablets 50 mg. Petitioner's Exhibit No. During the audit period, the pharmacy purchased 400 tablets of Dilaudid 2 mg. and 500 Percodan tablets. Id. The discrepancies uncovered by the audit exceeded significantly the five percent error rate that the investigators commonly see. Mr. Bludworth and Ms. Paige returned for a second visit on April 19, 1983, at about ten o'clock in the morning. Once again, the prescription department was unlocked and open. There was no "closed" sign and no pharmacist to be seen. This time Mr. Henderson's presence was procured by noon. On one of their visits, Mr. Henderson told the investigators that there had been a break-in at the pharmacy more than a year earlier. He said he had reported the incident at the time to the authorities but was unable to produce documentation of any such report. The investigators requested such documentation at the time of the visit, and Ms. Paige later telephoned him to ask again for documentation.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner suspend respondent's license for one (1) year. DONE and ENTERED this 20th day of October, 1983, in Tallahassee, Florida. ROBERT T. BENTON II 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 20th day of October, 1983. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Andrew Mobley Tampa Park Plaza Pharmacy 1497 Nebraska Avenue Tampa, Florida 33602 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Wanda Willis, Executive Director Department of Professional Regulation Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
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 The Respondent, Natalie Patton, is a licensed pharmacist and has been licensed since 1959. She is a graduate of Sanford University, Birmingham, Alabama, and was initially licensed in Alabama as a pharmacist. She has worked as a licensed pharmacist for twelve years in Highlands County in the vicinity of Sebring. She is licensed as a pharmacy consultant as well and has been employed at several hospitals and pharmacies in that geographical area. She opened her present pharmacy' business in November, 1978, in a rural area southwest of Sebring at the community of Spring Lake. Her's is the only pharmacy in seventeen miles and her business volume reflects the rural nature of her business location and clientele in that she fills an average of thirty-five to fifty prescriptions a day. On "Race Friday," the day prior to the Sports Car Race at Sebring, a man entered her pharmacy complaining of severe headache and allergy to fumes associated with the infield and pits at the racetrack. He asked for Darvon, explaining that this was the only medication successful in treating his headaches. He explained he was from another part of the State and had no way to contact his physician. She sold him a non-prescription drug. He came back the next day, the day in question, March 22, and explained that her suggestion that he go to the emergency room the day before was impractical because a newspaper ad he had seen described the emergency room as overloaded and turning patients away. He complained of a worsening headache. She testified that she felt sympathy for him and ultimately and reluctantly sold him, at her cost, four Darvon to be used that Saturday and four for that Sunday. The individual requesting the medication then revealed himself to be a Deputy Sheriff of Highlands County, who arrested her on the spot, charging her with dispensing the Darvon without a prescription in violation of the above authority. She ultimately was tried on the charges and convicted, but adjudication was withheld and she was placed on three years probation by the Circuit Judge. A second related criminal charge was ultimately dismissed. She has been under the direction of a probation officer since that time and must report all her activities and receive permission before traveling out of her county. She also has been required to pay fifty dollars a month to reimburse the public defender for his services on her behalf. She is still operating her business and her customers have professed loyalty to her and her business is still increasing in volume. She has never had any altercation with law enforcement authorities of any type in her past and has never been convicted of any felony or misdemeanor. With the agreement of counsel for the Petitioner, certain testimonial letters on her behalf from persons who were not in attendance at the hearing were admitted as composite exhibit 1. These letters attest to and establish the fact, in corroboration of her testimony, that she is a decent and useful citizen and that she was totally unaware that she was committing a felonious act. These letters corroborate her testimony and establish that she is a crucial asset to her rural community. She is depended upon by numerous citizens, many of whom are of advanced years and who require frequent medication and are unable to travel any great distance. She has obviously gone to great lengths to operate her business in a professional and compassionate manner even to the extent of delivering medications to senior citizens and others long after the closing hours of her pharmacy. These letters in support of her position also are replete with instances described where she adheres strictly to the dictates of the various physicians' prescriptions and refused on a number of occasions to prescribe medication without a prescription. There is no question that the evidence in this record establishes that the Respondent is clothed with the highest personal integrity and moral character and that the isolated incident when she dispensed medication in violation of the above authority is not characteristic of the regular and otherwise consistent manner in which she practices pharmacy and conducts her business. The Respondent's probation officer sent a letter which is incorporated in Respondent's Exhibit 1 attesting to her conscientious efforts to obey the law and her usefulness as a citizen. He expressed the belief that she was unaware that she was actually committing a crime when the subject violation occurred and that she was simply and compassionately attempting to help a customer in trouble. He is convinced that revoking her pharmacy license would serve no useful purpose and would indeed impose a hardship on the rural customers she serves. He firmly believes she would not consciously violate the law or purposefully commit an illegal act. The Respondent was authorized by the Circuit Judge in the Respondent's criminal proceeding to make the following statement on the record in this proceeding: In re Natalie Patton: In open Court, in disposing of this case, and putting Natalie Patton on probation without adjudication, I made note of the numerous letters I received from people in the community, urging the Court to be lenient. The Respondent then noted that there were a hundred and forty signatures on those testimonial letters. At the conclusion of the Respondent's case the Respondent requested that the penalty herein be limited to a letter of reprimand. The Petitioner introduced no evidence and otherwise took no position with regard to the question of an appropriate penalty.
Recommendation Having considered the foregoing findings of fact, conclusions of law, the candor and demeanor of the witness and the evidence in the record, it is RECOMMENDED: That Natalie N. Patton and Spring Lake Pharmacy remain licensed and that Natalie Patton be accorded a written reprimand by the Board regarding the subject violation and that she be placed on probation by the Board for a period of time coextensive with the probation imposed in the criminal proceeding related hereto during which time her conduct of the practice of pharmacy be subjected to periodic monitoring by the Board. DONE AND ENTERED this 2nd day of November, 1981, in Tallahassee, Florida. COPIES FURNISHED: William M. Furlow, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Michael J. Trombley, Esquire 329 South Commerce Avenue Sebring, Florida 33870 P. MICHAEL RUFF, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of November, 1981.
Findings Of Fact Based on the record evidence and the admissions made by Sandbank at hearing, the Hearing Officer makes the following findings of fact: Stanley Sandbank has been a licensed pharmacist in the State of Florida since 1975 and has actively engaged in the practice of pharmacy in this state since 1982. During the Fall of 1987, Sandbank was employed as a pharmacist at Rite- Aid Discount Pharmacy 2165 in Miami Beach, Florida. Toward the latter part of November of that year, Rite-Aid management received a telephone call from a Drug Enforcement Administration (DEA) agent, who stated that she had obtained a tip from a reliable informant that Sandbank "was selling drugs on the street." The DEA agent suggested that a controlled audit be conducted to ascertain whether these drugs were being misappropriated from the pharmacy at which Sandbank worked. Rite-Aid management followed the DEA agent's suggestion and performed such a controlled audit. The audit was completed on November 25, 1987. It revealed that 154 dosage units of Percocet and 201 dosage units of Percodan were unaccounted for and missing from the pharmacy's inventory of controlled substances. Percocet is a brand name of a "medicinal drug," as defined in Section 456.003(7), Florida Statutes, which contains Oxycodone, a controlled substance listed in Schedule II of Chapter 893, Florida Statutes. Percodan is a brand name of a "medicinal drug," as defined in Section 465.003(7), Florida Statutes, which also contains Oxycodone. Because Sandbank was the only pharmacist on duty during the time the audit was conducted, Rite Aid management believed that he was responsible for the shortages that had been discovered. Sandbank initially denied knowing anything about the matter, but later admitted his transgression. As Sandbank freely admitted, he had removed from the pharmacy and delivered to relatives and neighbors the following approximate quantities of controlled substances without first having been presented with a valid prescription and without Rite-Aid having received payment in full for these controlled substances: CONTROLLED SUBSTANCE QUANTITY Valium 10 mg. 300 Diazepam 10 mg. 400 Percodan 375 Percocet 360 Dilaudid 100 Hycodan Syrup 240 Placidyl 750 mg. 30 Valium, Dilaudid, Hycodan Syrup, and Placidyl are brand names of "medicinal drugs," within the meaning of Section 465.003(7). Valium contains Diazepam, which is a controlled substance listed in Schedule IV of Chapter 893, Florida Statutes. Dialudid contains Hydromorphone, which is a controlled substance listed in Schedule II of Chapter 893, Florida Statutes. Hycodan Syrup contains Hydrocodone, which is a controlled substance listed in Schedule III of Chapter 893, Florida Statutes. Placidyl contains Ethchlorvynol, which is a controlled substance listed in Schecdule IV of Chapter 893, Florida Statutes. Sandbank kept at least a portion of the money he had been given by this neighbors and relatives for having delivered to them the above-described controlled substances. He therefore reaped a financial gain as a result of his unauthorized and surreptitious diversion of these controlled substances from Rite-Aid Discount Pharmacy #2165.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Pharmacy enter a Final Order finding that Stanley Sandbank violated Section 465.016(1)(e), Florida Statutes, as alleged in the Administrative Complaint, and imposing the above-described disciplinary action which the Department of Professional Regulation has proposed. DONE and ENTERED this 25th day of April, 1989, in Tallahassee, Florida. STUART M. LERNER 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 25th day of November, 1989. COPIES FURNISHED: Michael A. Mone', Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Stanley Sandbank 4300 Sheridan Street Hollywood, Florida 32399-0750 Rod Presnell, Executive Director Board of Pharmacy Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Kenneth D. Easley, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
