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
The Issue The issues to be determined here concern disciplinary action to be taken against Respondent for those administrative offenses pertaining to the controlled substances Talwin, Dilaudid and Paregoric dispensed by Scottie Drug Store in Duval County, Florida, during the period April 2, 1981, to March 23, 1982, in violation of various provisions of Chapter 465, Florida Statutes. These contentions made by the State of Florida, Department of Professional Regulation, are more particularly described in the Administrative Complaint, DPR Case No. 0022146.
Findings Of Fact Howard E. Staats is a pharmacist who has been issued a license by the State of Florida, Department of Professional Regulation, Board of Pharmacy. The license number is 0007704. At times relevant to this proceeding, Staats, practiced pharmacy in Jacksonville, Florida. At all times pertinent to the Administrative Complaint, which is the focus of this action, Staats was the managing pharmacist at American Apothecaries, Inc., which does business as Scottie Drug Store at 41 Arlington Road South, Jacksonville, Florida. A copy of Respondent's most recent license may be found as Petitioner's Exhibit No. 1, admitted into evidence. Petitioner's Exhibit No. 2, admitted into evidence, is a copy of the permit for American Apothecaries. Sometime within the period March 23, 1982, through March 29, 1982, an audit was conducted at the Scottie Drug Store. The audit revealed that in the period April 2, 1981, through March 23, 1982, the drug store had purchased 66,900 tablets of Talwin, 50 mg., had sold 29,373 tablets of that drug, had lost by robbery or theft, 1,000 tablets of the drug, leaving 36,527 tablets of Talwin unaccounted for. During that same audit period, the pharmacy purchased 4,000 tablets of Dilaudid, 4 mg., selling 3,025 tablets of that drug, losing by robbery or theft, 200 tablets of the drug and failing to account for 775 tablets of the drug. Finally, during the audit period, 2,064 ounces of Paregoric had been purchased and 699 ounces sold, with the remaining amount of 1,285 ounces being unaccounted for. See Petitioner's Exhibit No. 4. Talwin is a Schedule IV controlled substance within the meaning of Chapter 893, Florida Statutes. Dilaudid is a Schedule II controlled substance within the meaning of Chapter 893, Florida Statutes. Paregoric is a Schedule III controlled substance within the meaning of Chapter 893, Florida Statutes. The audit which was conducted at the Scottie Drug Store revealed numerous prescriptions for the controlled substance Talwin, 50 mg., written on prescription blanks of Drs. W. W. Shell, Jr., and L. T. McCarthy, Jr., which had allegedly been signed by those physicians, when in fact the patients for whom the prescriptions were written were unknown to the physicians and the signatures of the physicians were forgeries. Those prescriptions are depicted in Petitioner's Exhibit No. 5, admitted into evidence. During the period covered by the audit, it was shown that Staats filled a number of prescriptions for various patients for the controlled substance Talwin, which had been written on prescription pads of Methodist Hospital and Baptist Medical Center in Jacksonville, Florida, and signed by individuals who are not physicians having hospital privileges at those medical centers nor practicing as physicians in the Duval County area. Copies of those prescriptions may be found as Petitioner's Exhibit No. 6, admitted into evidence. In the course of the time sequence related to the audit review process, it was discovered that Staats had refilled numerous prescriptions for controlled substances on more occasions than had been authorized by physicians, namely prescription No. 51632 was refilled twice although the physician indicated there were to be no refills; prescription No. 51579 was refilled once although the prescription indicated there should be no refills; prescription No. 51639 was refilled twice although the prescription indicated there should be no refills; prescription No. 51217 was refilled once although the prescription indicated there should be no refills; prescription No. 51238 was refilled once although the prescription indicated that there should be no refills; prescription No. 53010 was refilled once although the prescription indicated that there should be no refills; prescription No. 53597 was refilled four (4) times although the prescription indicated that it should only be refilled once; prescription No. 53537 was refilled once although the prescription indicated that it should not be refilled; and prescription No. 53592 was refilled twice although the prescription indicated that there should be no refills. Petitioner's Exhibit No. 7, admitted into evidence, is copies of prescriptions spoken to in this paragraph. Respondent Staats had operated the Scottie store under a lease arrangement during 1979 and 1980, and in January of 1981, took a position as an active pharmacist in that store. After becoming the principal operating pharmacist in the Scottie store, Staats began to receive prescriptions from doctors Shell and McCarthy for the substance Talwin and when a prescription purportedly written by those physicians was in question, Staats would call the office of the physicians for confirmation, which at times would be given over the phone and at other times an indication was made that a call back from the physician's office to Staats would be necessary. Some of the indications of physicians' prescription authority of the substances in question would be placed on a separate log and not on the back of the prescription and on other occasions, the note of the prescription information would be placed on the back of the prescription form and not in the log. Normally, this information would be reflected both in the log and on the back of the prescription. There were occasional circumstances in which the authority was not stated in either place. At approximately the same time as was covered by the audit, Staats began to ask for identification from customers who were seeking prescriptions for Talwin and noted that the demand for that substance declined with the advent of the request for identification. Staats posted a notice in the window of the pharmacy to the effect that state law imposed a fine of $5,000.00 or might cause incarceration for five (5) years for presenting forged prescriptions or conspiring or agreeing with another to have a forged prescription filled. On two (2) occasions Staats called law enforcement officials on a circumstance involving suspect prescriptions and those persons were apprehended. (Poor record keeping and mistakes in estimating the amount of losses due to a robbery and a larceny which occurred in the period covered by the audit contributed to the unaccounted for controlled substances, but those matters of record keeping and theft reports would cause only a slight differential in the disparity, as opposed to explaining the whereabouts of a substantial portion of the missing controlled substances.) Beginning on March 25, 1982, Staats began to keep a daily inventory log on the substance Talwin and a number of other controlled substances. A copy of that log may be found as Respondent's Exhibit No. 9, admitted into evidence. In addition, certain out-of-date and otherwise undesirable controlled substances, Schedules II, III and IV, have been removed from inventory and turned over to appropriate authorities for destruction.
Recommendation That a final order be entered placing Respondent Staats on probation for a period of two (2) years, with a special requirement that Staats attend continuing education courses dealing with the proper methods for prescribing controlled substances and to the extent possible, courses which emphasize the detrimental effect to the public when those controlled substances are abused and requiring that Respondent work under the supervision of another pharmacist for the first six (6) months of his probationary period. DONE and ENTERED this 17th day of November, 1982, in Tallahassee, Florida. CHARLES C. ADAMS 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 17th day of November, 1982.
Findings Of Fact The parties have stipulated that the Respondent is a licensed medical doctor, having been issued license number ME 0029977. He has been licensed in the State of Florida for approximately seven years and is a board eligible urologist. The Respondent practices in the field of general practice and urology. The Petitioner is an agency of the State of Florida charged with administering and enforcing the licensure standards and practice standards set forth in Chapter 458, Florida Statutes, and related rules. The Respondent's wife has a medical condition which causes her to be chronically drowsy and to be difficult to awaken or even to remain awake sometimes, even while conversing with other people. On or about April 18, 1980, the Respondent prescribed a total of 60 Ritalin tablets, a Scheduled II controlled substance, for Mrs. Tandon. The Respondent established that these were prescribed for a medically justifiable purpose, to enable his wife to remain awake and alert, and that the Respondent, in all prescriptions to family members, including his wife, was extremely conservative. Although he prescribed his wife Ritalin from time to time, he sometimes withheld it in order to avoid any chance of a dependency developing. In any event, because of her (unnamed) medical condition, the Ritalin was prescribed for a medically justifiable purpose. The Respondent did not prescribe Ritalin for his own use on this occasion. More than two years later, on November 23, 1982, the Respondent executed a similar prescription for 60 Ritalin tablets. Once again these were not for the Respondent's own use. On December 13, 1979, however, the Respondent prescribed a total of 50 Ritalin tablets to himself, as indicated on the prescription. These Ritalin were in reality for his wife's use. On November 4, 1980, and on July 5, 1981, the Respondent on each of those occasions prescribed 30 Nembutal tablets for himself and his wife. This Nembutal was prescribed by the Respondent to himself because of a condition he had experienced of late involving difficulty in sleeping. The difficulty in sleeping was caused by anguish that he, as well as his wife, suffered related to their daughter's divorce which occurred not long after her carefully arranged marriage and elaborate East Indian wedding ceremony. In the East Indian culture such a divorce is a very traumatic experience for a family such as Dr. Tandon's, and it was sufficiently upsetting to Dr. Tandon and his wife to cause both of them to seek medical care. Indeed, Mrs. Tandon developed a hypertension condition during this period of family turmoil. The doctor freely admitted that on these occasions he prescribed the Nembutal for himself and on the December 13, 1979 occasion, prescribed the Ritalin not for himself, but in reality for his wife's use. The Respondent had no knowledge that such a pattern of prescribing for himself or for himself on behalf of his wife or a family member is legally proscribed under Chapter 458, Florida Statutes (1981) . . . Indeed, in India, as well as in Britain and parts of Europe, it is traditionally and legally acceptable for physicians to prescribe for themselves and their family members. The Respondent established, as corroborated by Respondent's Exhibit D, that he is indeed a stable and sober person and a competent and caring physician. He openly prescribed the medication for his wife during a period of great stress and sadness on her part and could have easily have asked a colleague to write a prescription for her. He wrote the prescription in an open, honest manner, which he freely disclosed to the Petitioner when questioned, because he simply felt there was no reason to have a colleague issue the prescription since he was unaware that it was illegal for him to do so. Indeed, by Dr. David Honey, whose corroborative testimony appears in Exhibit D, it was shown that he could have given his wife sample medications which doctors characteristically have on hand in their offices, but preferred instead to forthrightly write a prescription for it, thus creating a record of that medication's prescription and use. In short, the Respondent established that he is a competent physician who is not given to misprescribing or overprescribing or otherwise misusing drugs at all. Indeed he currently, and before the subject prosecution, devoted approximately two days a week to a drug rehabilitation center and has donated his time for television appearances in his work combatting drug abuse. His practice has never been characterized by anything other than conservative prescription and administering of drugs and medications. He excels in his practice in the field of urology and indeed earned one of the highest scores on the examination when he was admitted to practice in Florida. Near the conclusion of the proceeding, counsel for the Petitioner forthrightly agreed to dismiss the majority of the counts of the administrative complaint inasmuch as the evidence did not support them. Thus, the Petitioner continues to proceed with regard to the alleged violation of Section 458.331(1)(r), Florida Statutes (1981), related to the Respondent's prescribing of medication to himself. Thus, Counts I, II, V, VI, I, XI, and XII remain at issue at whole or in part in this proceeding.
Recommendation Having considered the foregoing findings of fact, conclusions of law and the evidence of record, it is, therefore RECOMMENDED: That Dr. Prem Narain Tandon be found guilty of violating Section 458.331(1)(r), Florida Statutes (1981), and that he be fined $200 and that his license to practice medicine be subjected to a one month probationary status and that the administrative complaint, in all other particulars, be dismissed. DONE and ENTERED this 30th day of November, 1983, in Tallahassee, Florida. P. MICHAEL RUFF, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of November, 1983. COPIES FURNISHED: Barbara K. Hobbs, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Prem Narain Tandon, M.D. 15 West Columbia Street Suite "J" Orlando, Florida 32806 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department or Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact Respondent, Norman G. Becker, Jr., is a licensed dentist having been issued license number DN 0002281 by Petitioner, Department of Professional Regulation, Board of Dentistry. He has practiced dentistry in the State since 1958. On or about September 8, 1980, Respondent furnished one William R. Northlick, 101 North Grandview, Mount Dora, Florida, a written prescription for four-ounces of dimethvl sulfoxide (DMSO). Northlick had been a patient of Respondent for approximately ten years, had complained of severe elbow pain, and inquired as to the status of DMSO and where it could be obtained. Respondent told him it was available at a local drug store and advised he could try a small amount. At an undisclosed date in 1980, Respondent was approached by a professional golfer named Gary Weintz who commlained of golfers elbow and who asked about the availability of DMSO. Respondent is active in arranging golf functions on the Professional Golf Association-(PGA) tour and presumably met Weintz, uho is a member of the PGA, in that capacity. Respondent telephoned William Kennedy, a pharmacist at Thayer's Colonial Pharmacy in Orlando, Florida, and asked whether DMSO could be legally prescribed. Kennedy replied that he believed it permissible for Becker to assist Weintz in obtaining the drug and thereafter took a prescription for the same over the telephone. Before filling the prescription, Kennedy required Weintz to sign a patient release form acknowledging that DMSO was a veterinary product and releasing anyone from liability due to its use. Other than the two occasions referred to above, Becker has not prescribed DMSO at any time. He did not charge Northlick or Weintz for his assistance nor did he provide any follow-up care or treatment to either individual. Respondent has never personally used DMSO or applied it to any other patient or friend. Respondent has been a practicing dentist in Florida since 1958, and has lived in Winter Park, Florida, for the last eighteen years. His specialty is periodontics and he was the founder and first president of the Florida Society of Periodontics. He enjoys an excellent personal and professional reputation in the community. This was attested to by Dr. Neil G. Powell, immediate past president of the Florida Dental Association. Other than the present incident, Respondent's record has been exemplary, and he has never been subject to prior disciplinary action. Although Becker wrote the prescription for Northlick on a prescription pad, he did not consider it to be a prescription item". Rather, he considered it the same as when giving customers written instructions for obtaining water piks, electric toothbrushes and other non-prescription items. For this reason, he wrote the words "use as directed" on the prescription pad in lieu of the detailed instructions typically given when writing a normal prescription.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Respondent be found guilty of violating Subsection 466.028(1)(z), Florida Statutes, as charged in the Administrative Complaint and that the remaining charge in paragraph 11a be dismissed. It is further RECOMMENDED that Respondent be issued a private reprimand. DONE and ENTERED this 22nd day of February, 1982, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of February, 1982. COPIES FURNISHED: Theodore R. Gay, Esquire 130 North Monroe Street Tallahassee, Florida 32301 James F. Page, Jr., Esquire P.O. Box 3068 Orlando, Florida 32802 Salvatore A. Carpino, Esquire 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact The Respondent Herman Ginsberg is a licensed pharmacist having been issued license number 0008019. The last known address of the Respondent is 775 Northeast 164th Street, North Miami Beach, Florida 33162. At all times material to this proceeding, the Respondent was the managing pharmacist at Jaffe Pharmacy, also known as Jaffe Discount Drugs, located at 737 Northeast 167th Street, North Miami Beach, Florida 33162. On or about November 26, 1980, the Respondent Ginsberg directed a clerk at the pharmacy, Lorraine Gronfine to remove nine (9) prescriptions from the class II prescription records and place them under a desk blotter. The scripts were pulled by Ms. Gronfine prior to a drug inspection by the authorities. According to the Respondent Ginsberg, he was ordered by the manager of the pharmacy, Ed Terry, to pull the prescriptions in order to inflate an insurance claim resulting from a burglary which occurred in September 1980. The Respondent complied with Mr. Terry's request and reported that drugs were stolen which were not in fact stolen in order to inflate an insurance claim to approximately $7,000. The prescriptions were discovered under the blotter by Irving Losee, another pharmacist employed by Jaffe, who turned them over to Graymark Security. Graymark personnel questioned both the Respondent and Ms. Gronfine about the prescriptions and both gave statements to Graymark concerning how the prescriptions came to be placed under the blotter. Many, although not all, of the prescriptions found by Losee were altered. No testimony expert or otherwise was introduced to prove that the Respondent altered the prescriptions in question. As noted by counsel for Respondent, no direct evidence was introduced to rebut the Respondent's sworn denial that he personally altered the prescriptions. In the normal course of business at Jaffee Pharmacy, a patient log was kept for all prescriptions filled on a daily basis. It is undisputed by the parties that the patient log, which was kept by the Respondent, was not altered and reflected the actual number of pills dispensed by the pharmacy. In order to divert classified drugs for personal profit, it is logical to assume that the Respondent would have altered the patient logs along with the prescriptions to consistently cover the amount of classified drugs ordered from pharmaceutical companies and placed on record with the Drug Enforcement Administration. Indeed, the failure to alter the daily patient logs to be consistent with the altered prescriptions was one of the ways that the problem with the altered prescriptions was uncovered. Although Mr. Terry examined the patient logs nightly to grade his employees on their sales of drugs, this would not have necessarily stopped the logs from being changed to conform to the altered prescriptions. The Respondent or anyone with access to the patient logs, could have altered the logs after the nightly review and conform the logs and prescriptions without arousing undue suspicion. No testimony was presented concerning this point other than that the logs did not go to accounting and were presented to Mr. Terry for his review. If Mr. Terry kept the logs and the Respondent had no further access to them, the Petitioner's theory concerning the alterations would be more plausible; however, the record failed to show that the Respondent lacked the ability to alter the logs subsequent to Mr. Terry's review. Each prescription placed into evidence and filled by the Respondent is marked as being "verified by the issuing physician." The Respondent has admitted that some of these prescriptions were not verified and that the certifications were erroneous. The Respondent admitted that a person named Fred Sessler, who was associated with a stress or obesity clinic, was permitted to pick up controlled drugs for the clinic without a prescription. Mr. Sessler was apparently permitted this privilege because the Respondent knew that one of the clinic physicians would eventually furnish a prescription. Additionally, the Respondent has admitted that in connection with the Sessler transactions, he failed to immediately record all the information required in order to dispense oral prescriptions and failed to notify the Drug Enforcement Administration that he was emergency dispensing via telephone. While acting as managing pharmacist at Jaffee, the Respondent ordered and distributed excessive quantities of a Schedule II drug. (See Petitioner's Exhibit 26 and Respondent's Exhibit 1.)
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the license of the Respondent Herman Ginsberg be suspended for two (2) years and that he be placed on probation for three (3) years thereafter, subject to attending appropriate continuing education classes and working under the direct supervision of a pharmacist approved by the Board. DONE and ENTERED this 27th day of January, 1983, in Tallahassee, Florida. SHARYN L. SMITH Hearing Officer Division of Administrative Hearings Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of January, 1983.
Findings Of Fact At all times material hereto Respondent has been licensed as a pharmacist having been issued license number 0015784. Respondent's license was previously suspended for a period of five (5) years by Final Order of the Florida Board of Pharmacy on June 15, 1984 in Case Number 0036893. In that prior case Respondent admitted to self medicating herself with controlled substances in violation of Section 465.016(1)(d)2, Florida Statutes. Respondent's license is therefore currently under suspension and has been suspended since June 15, 1984. Respondent was hospitalized at Shands Teaching Hospital in June, 1984 by George W. Sypert, M.D., for back and chest pains resulting from an automobile accident in May, 1983. This was Respondent's second hospitalization for treatment resulting from the accident. While hospitalized Dr. Sypert performed surgery on Respondent who was also attended by J. Marc Simard, M.D., a resident at the time. It was Dr. Simard who prepared the discharge summary on Respondent on June 19, 1984 and also wrote a discharge prescription for 10 Percodan which were to be taken one every six hours for severe pain remaining from the surgery which Dr. Sypert had performed. Both Respondent and her husband, George W. Bowen, were under the belief that Respondent would be "adequately medicated" for pain after her operation and upon her discharge. Mr. Bowen was formerly a licensed pharmacist in Florida, but his license has been revoked due to violations involving controlled substances. Mr. Bowen was extremely frustrated and concerned about the pain his wife was suffering and did not feel that 10 Percodan would be sufficient for her discharge. The Percodan prescription was given to Mr. Bowen who admitted during his testimony that he altered the prescription by adding a zero so that the prescription was then for 100 Percodan. Respondent never saw the prescription before or after it was altered, and her husband did not tell her what he had done. Mr. Bowen took this action out of concern for his wife and the pain she was suffering, and he did not take any of the Percodan himself. He had attempted to contact Dr. Sypert to request an increase in the prescription when he saw that Dr. Simard had written it for only 10 Percodan, but he was unsuccessful. Mr. Bowen presented the altered prescription at Eckerd's Drugs on June 20, 1984 and Russell Blaser, a licensed pharmacist, filled the prescription with 100 Percodan, which was paid for by Mr. Bowen and given to Mr. Bowen. Respondent was with her husband when he filled the prescription, but was almost immobile, having just been discharged. Blaser called Dr. Simard after he had filled the prescription to advise Dr. Simard that, due to Respondent's previous drug dependency, he felt that any further prescriptions should be for a lesser amount. It was at this time that Dr. Simard said the prescription he had written was for only 10 Percodan, not 100. Respondent was arrested on or about June 22, 1984, for obtaining a controlled substance by fraud. Following the arrest she learned for the first time that her husband had altered the prescription, and she thereupon destroyed the remaining Percodan.
Recommendation Based upon the foregoing, it is recommended that the Board of Pharmacy issue a Final Order dismissing these charges against Respondent. DONE and ENTERED this 5th day of November, 1985, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 5th day of November, 1985.' APPENDIX Adopted in Finding of Fact 1. Rejected in Findings of Fact 3 and 4. Adopted in Findings of Fact 2 and 6. Rejected in Findings of Fact 3, 4 and 7. Rejected as a conclusion of law which is not based on evidence in the record. COPIES FURNISHED: Rod Presnell, Executive Director Board of Pharmacy Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Deborah S. Bowen 1033 N.E. 8th Avenue Gainesville, Florida 32601 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Salvatore A. Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
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
