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 central issue in this case is whether the jeopardy assessment filed by the Department against Petitioner should be affirmed.
Findings Of Fact Based upon the testimony of the witnesses and the documentary evidence received at the hearing, I make the following findings of fact: The petitioner, Albert Charles Harris, is also known as Bert or Albert Harris. During the month of July, 1986, Petitioner was employed to copilot a flight from Florida to Colombia and to return to an airstrip located near Lakeland, Florida. The private flight was arranged for the purpose of bringing 460 kilograms of cocaine into the State of Florida. The airplane was owned by a drug importation organization that arranged transportation for drugs from Colombia to the United States. Cocaine is a controlled substance enumerated in Section 893.03, Florida Statutes. Richard Bahmann was employed as the pilot for the July flight in which Petitioner participated. Frank Bahmann was also employed to fly a cover plane for the aircraft piloted by Richard Bahmann and Petitioner. The "mission" of the Bahmanns and Petitioner was to assure the safe delivery of cocaine from its owners in Colombia to its owners in Florida. Petitioner did not own the substance transported. Petitioner's employers did not own the substance transported. Petitioner and the others were to be paid based upon the volume of cocaine they were able to transport to Florida. Petitioner participated in the transportation of 460 kilograms of cocaine from Colombia to Florida in July, 1986. The street value of cocaine in the Miami area in July, 1986 was $35,000/kilo. The amounts owed to the Bahmanns and Petitioner for their participation in the transportation was $330,000. There is no evidence as to what amount Petitioner's employers were paid for their part in the transportation.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED: That the tax warrant and jeopardy assessment filed against Albert Charles Harris be affirmed. DONE and RECOMMENDED this 30th day of August, 1988, in Tallahassee, Florida. JOYOUS D. PARRISH Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of August, 1988. COPIES FURNISHED: Douglas Stratton 505 Lincoln Road Miami Beach, Florida 33139 William Watson and Jeffrey Dikman Department of Legal Affairs Tax Section, Capitol Building Tallahassee, Florida 32399-1050 Sam D. Alexander Executive Director 102 Carlton Building Tallahassee, Florida 32399-0100 William D. Townsend General Counsel 104 Carlton Building Tallahassee, Florida 32399-0100 =================================================================
The Issue Whether respondent committed the acts alleged in the Administrative Complaint, and, if so, whether respondent's license should be revoked or suspended, or whether other discipline should be imposed.
Findings Of Fact Respondent is a licensed pharmacist in the State of Florida, having been issued license number 005517, and was so licensed at all times material to the Administrative Complaint. The respondent is engaged in the practice of pharmacy at Interbay Discount Drugs, 4332 South Manhattan, Tampa, Florida, where he is the proprietor and the sole pharmacist. On April 23, 1986, Ms. Beth Christie, investigation specialist for the Department of Professional Regulation, conducted a pharmacy inspection of Interbay Discount Drugs. During the pharmacy inspection, Ms. Christie reviewed certain documents, including the Certified Exempt Narcotic Record of Retail Sales maintained by Interbay Discount Drugs. This record, or log, is required to be maintained by a pharmacist to reflect the pharmacist's dispensing of Schedule V drugs. The log must show to whom the Schedule V drug was dispensed, the date it was dispensed, and identify the dispensing pharmacist. The log is used to ensure that certain amounts of exempt drugs are not dispensed to the same customer within a 48-hour period. Since respondent was the sole pharmacist at Interbay Drugs, all the log entries are followed by his initials. Ms. Christie initially reviewed the log while conducting her inspection at Interbay Discount Drugs. She noticed the same names appearing over and over again throughout the log which covered approximately a two-year period. Subsequently, Ms. Christie reviewed the log more extensively and prepared a patient profile for Cynthia D. Anderson and Vester L. McDaniel based on the information contained in the log. The patient profiles contained the date the drug was dispensed to the patient, the drug dispensed, and the quantity. The patient profile revealed that Vester L. McDaniel received Robitussin AC, 2 oz., on the following dates in the 1 1/2-year period from November 30, 1984, through April 21, 1986: 11-30-84 04-25-85 08-20-85 11-21-85 02-08-86 12-04-84 04-27-85 08-22-85 11-23-85 02-10-86 12-11-84 05-02-85 08-24-85 11-26-85 02-12-86 12-15-84 05-07-85 08-27-85 11-30-85 02-14-86 12-20-84 05-11-85 08-29-85 12-03-85 02-17-86 12-22-84 05-16-85 09-02-85 12-04-85 02-18-86 12-27-84 05-21-85 09-05-85 12-07-85 02-21-86 12-31-84 05-25-85 09-07-85 12-10-85 02-24-86 01-05-85 05-27-85 09-10-85 12-12-85 02-26-86 01-10-85 05-29-85 09-12-85 12-14-85 02-28-86 01-15-85 06-03-85 09-14-85 12-17-85 03-03-86 01-22-85 06-07-85 09-17-85 12-19-85 03-10-86 01-29-85 06-11-85 09-21-85 12-21-85 03-12-86 02-02-85 06-15-85 09-26-85 12-23-85 03-14-86 02-06-85 06-18-85 10-01-85 12-26-85 03-17-86 02-09-85 06-22-85 10-03-85 12-28-85 03-19-86 02-12-85 06-28-85 10-08-85 12-31-85 03-21-86 02-16-85 07-02-85 10-10-85 01-02-86 03-24-86 02-18-85 07-06-85 10-12-85 01-04-86 03-26-86 02-21-85 07-09-85 10-14-85 01-06-86 03-28-86 02-23-85 07-13-85 10-15-85 01-08-86 03-31-86 02-26-85 07-16-85 10-22-85 01-11-86 04-02-86 03-01-85 07-18-85 10-24-85 01-14-86 04-04-86 03-05-85 07-20-85 10-26-85 01-16-86 04-06-86 03-08-85 07-23-85 10-29-85 01-18-86 04-09-86 03-14-85 07-30-85 10-31-85 01-20-86 04-11-86 03-18-85 08-01-85 11-02-85 01-22-86 04-14-86 03-23-85 08-03-85 11-05-85 01-24-86 04-17-86 04-04-85 08-06-85 11-07-85 01-27-86 04-19-86 04-06-85 08-08-85 11-09-85 01-29-86 04-21-86 04-10-85 08-10-85 11-14-85 01-31-86 04-18-85 08-13-85 11-16-85 02-03-86 04-20-85 08-17-85 11-19-85 02-06-86 In addition to the above, Mr. McDaniel received Terpin Hydrate with Codeine on September 19, 1985, and November 12, 1985. The record reveals that Mr. McDaniel received Robitussin AC, 2 oz., on October 14 and 15, 1985, and on December 3 and 4, 1985. The quantity of codeine contained in the Robitussin AC dispensed to Mr. McDaniel by respondent within the 48-hour period from 10-14-85 to 10-15-85 and the 48-hour period from 12-3-85 to 12-4-85 exceeded 120 milligrams. The patient profile of Cynthia D. Anderson revealed that Ms. Anderson received Robitussin AC, 2 oz. on February 24, 1984, and received Novahistine DH, 2 oz., on the following dates in the 2-year period from April 14, 1984, to April 23, 1986: 04-25-85 09-04-85 12-09-85 02-21-86 04-14-84 04-29-85 09-06-85 12-11-85 02-24-86 04-20-84 06-29-85 09-09-85 12-13-85 02-26-86 05-04-84 07-02-85 09-11-85 12-16-85 02-28-86 07-31-84 07-06-85 09-13-85 12-21-85 03-03-86 08-23-84 07-09-85 09-16-85 12-23-85 03-05-86 09-05-84 07-11-85 09-18-85 12-30-85 03-07-86 09-08-84 07-13-85 09-20-85 01-01-86 03-10-86 10-11-84 07-15-85 09-23-85 01-03-86 03-12-86 10-13-84 07-17-85 09-30-85 01-07-86 03-14-86 10-16-84 07-22-85 10-02-85 01-10-86 03-17-86 10-23-84 07-24-85 10-04-85 01-13-86 03-19-86 11-01-84 07-26-85 10-07-85 01-14-86 03-21-86 11-15-84 07-29-85 10-09-85 01-16-86 03-24-86 11-17-84 07-31-85 10-11-85 01-20-86 03-26-86 12-07-84 08-02-85 10-15-85 01-22-86 03-28-86 12-27-84 08-07-85 10-17-85 01-24-86 03-31-86 01-28-85 08-09-85 10-21-85 01-27-86 04-02-86 01-30-85 08-12-85 10-23-85 01-29-86 04-04-86 02-06-85 08-14-85 10-25-85 01-31-86 04-06-86 02-12-85 08-16-85 10-29-85 02-03-86 04-08-86 02-15-85 08-20-85 10-31-85 02-05-86 04-10-86 02-18-85 08-22-85 11-18-85 02-07-86 04-14-86 02-21-85 08-24-85 11-22-85 02-10-86 04-14-86 04-06-85 08-26-85 11-27-85 02-12-86 04-18-86 04-09-85 08-28-85 12-02-85 02-14-86 04-21-86 04-11-85 08-30-85 12-04-85 02-17-86 04-23-86 04-23-85 09-02-85 12-06-85 02-19-86 As the above shows, respondent dispensed Novahistine DH, 2 oz., to Ms. Anderson twice on April 14, 1986. 2/ The quantity of codeine contained in the Novahistine DH dispensed to Ms. Anderson on April 14, 1986, exceeded 120 milligrams. Ms. Christie asked respondent about the repeated dispensing of Robitusin AC and Novahistine DH to Mr. McDaniel and Ms. Anderson, and respondent stated that both complained of a chronic cough. However, Ms. Christie observed Ms. Anderson, who happened to purchase Novahistine DH while Ms. Christie was performing her inspection, and Ms. Anderson did not cough at all while she was in the store. Respondent also told Ms. Christie that he continued to provide the drugs to Ms. Anderson and Mr. McDaniel because "they were regular customers and purchased other items in his store [and] it would be awkward for him to refuse to sell the exempt narcotics to them." [T-30] Codeine is a very potent narcotic, and it can be addictive. Approximately 60 milligrams of codeine are contained in one ounce of Robitusin AC, Novahistine DH, and Terpin Hydrate with Codeine. Robitusin AC, Novahistine DH, and Terpin Hydrate with Codeine, in two ounce quantities, are Schedule V controlled substances. No more than two ounces of these drugs can be dispensed by a pharmacist to the same person within a 48-hour period without a prescription. Although Robitusin AC, Novahistine DH, and Terpin Hydrate with Codeine are cough depressants, there are much better things for people with chronic coughs than cough depressants that contain narcotics. A pharmacist who is presented with a request for Robitusin AC, 2 oz., by the same customer every two or three days should be very concerned and cautious. First, the pharmacist should be concerned about the health of the customer. A chronic coughing problem over a period of time should be treated professionally by a physician, not a pharmacist. A pharmacist should advise the customer to see a physician and refuse to sell the customer any more of the drug. Second, the pharmacist should be cautious because of the potential for abuse of the drug. It would be prudent for a pharmacist to refuse to dispense the drug after about three requests within a short period of time. To dispense Robitusin AC regularly over a two-year period cannot be considered dispensing the drug in good faith as a medicine. Any pharmacist dispensing the drug in good faith as a medicine would cease such regular dispensing of the drug long before two years had elapsed. The dispensing of Robitusin AC, 2 oz., and Terpin Hydrate with Codeine to Mr. McDaniel from November 30, 1984, to April 21, 1986, was not in good faith as a medicine. Novahistine DH is a essentially the same drug as Robitusin AC but made by a different company. The dispensing of Novahistine DH to Ms. Anderson from April 14, 1984, to April 23, 1986, was not in good faith as a medicine. Respondent admitted that he used poor judgement in dispensing the drugs to Mr. McDaniel and Ms. Anderson, but he denied that he dispensed the drugs not in good faith as a medicine. Mr. McDaniel was a heavy smoker and had a chronic cough. Respondent stated that he was just not aware that Mr. McDaniel had been receiving Robitusin AC for the period of time that he had. Respondent stated that Ms. Anderson had a family history of chronic bronchitis and respondent felt the medication was needed. Respondent also stated that he did not sell more than two ounces of either Robitusin AC or Novahistine DH to Ms. Anderson or Mr. McDaniel within a 48-hour period, although he admitted that his log reflected that such had occurred. Respondent contended that the customers had written in the wrong dates.
Recommendation Based upon the foregoing findings of fact and conclusions of law it is RECOMMENDED that the Board of Pharmacy enter a final order finding respondent committed those acts set forth in Counts I, II, III, and IV of the Administrative Complaint, imposing an administrative fine of $200 for each of the four counts, for a total fine of $800, and placing the respondent on probation for a period of one year under such terms and conditions as the Board may deem appropriate. DONE and ORDERED this 17th day of April 1987, in Tallahassee, Florida. DIANE A. GRUBBS 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 April 1987.
The Issue Whether disciplinary action should be taken against Respondent's license to practice medicine based on the administrative complaint in this case, which charges, in general, that he obtained his license through fraudulent misrepresentations and is unable to practice medicine safely because of illness or use of drugs he prescribed for himself illegally under the names of fictitious patients?
Findings Of Fact The Parties Petitioner, the Board of Medicine, created by Chapter 458, Florida Statutes, (the "Medical Practice Act,") is the regulatory authority charged with regulating the practice of medicine in the State of Florida. The Board is within the Agency for Health Care Administration, Section 20.42, Florida Statutes, which, in turn, is within the Department of Business and Professional Regulation. Id. In particular, as is pertinent to this case, the Board has the power to impose disciplinary penalties on a licensee when it finds guilt of any of the grounds set forth in subsection (1) of Section 458.331, Florida Statutes, the "grounds for disciplinary action" section of the Medical Practice Act. Respondent, John Mark Pennington, M.D., is currently a licensee of the Board of Medicine. He has been continuously licensed as a physician in Florida since March 11, 1994. Currently residing in Terra Ceia, Florida, Respondent has a specialty in anesthesiology. He does not, however, presently practice in his specialty. He practices, instead, as a physician in a walk-in medical clinic where he is closely monitored and his access to drugs and medication is completely restricted. The reason for not presently practicing as an anesthesiologist and being closely monitored at the walk-in clinic is the same: an addiction to narcotics. In recovery from the disease of chemical dependency at the time of hearing, and as long as he remains in recovery, Dr. Pennington is not presently impaired as the result of his addiction. Respondent's Checkered Past History of Drug Use Dr. Pennington's use and abuse of drugs spans many years. His illegal drug use began when he was a teenager in high school. In addition to drinking, he was using marijuana, cocaine and other drugs. He continued in college to use drugs, including amphetamines. In 1981, Dr. Pennington graduated from pharmacy school and began work as a pharmacist licensed by the State of Georgia in the City of Savannah. During his employment, he would take from the pharmacy, without the benefit of a medical prescription and without authorization from the pharmacy, certain drugs for his personal use. These included opiate derivatives, Hydrocordone, for example, which are classified as narcotics, as well as amphetamines and amphetamine-like medications such as Ritalin. Sometime in 1981, shortly after he began using narcotics, Dr. Pennington became addicted to them. Dr. Pennington managed to conceal his narcotic addiction from his closest associates, including his former wife, who was employed as a fellow pharmacist with him at the pharmacy in Savannah. In 1985, following an inventory at the pharmacy that indicated a discrepancy in narcotics, Dr. Pennington admitted his drug usage. He went directly into treatment at Willingway Hospital in Statesboro, Georgia where he remained for six weeks until his release. As the result of the discovery and Dr. Pennington's admission, disciplinary proceedings were brought against Dr. Pennington by the Georgia State Board of Pharmacy. The Georgia Administrative Hearing At the hearing during those proceedings, Dr. Pennington acknowledged his addiction. He testified that he knew that he would have to deal with addiction the rest of his life. But, he further testified, thanks to being in recovery as a result of the program at Willingway and a continuing program of treatment, that he was then drug-free and committed to remaining so. Moreover, he testified, that he felt there was no pressure too great to cause him to return to illicit use of drugs. In his view, no pressure was too great because he was committed to the ongoing drug treatment program in which he was then involved. He found the program to be an effective method for dealing with the addiction, a method he had not even known existed prior to his entry into the Willingway program. With regard to the effect the addiction and his behavior had on his life and others, Dr. Pennington testified: There is no way I can really express the guilt I feel and the remorse I feel for what I have done. I just want to do my best, and whatever the Board wants I will follow any direction they want me to go into. I embarrassed my profession by doing this. I almost lost my life, and my family, and my job and everything else. Regardless of what decision is made, I am going to go in the right direction to get my life back to the way it's supposed to be. Petitioner's Ex. No. 4, pgs. 46 - 47. At this same hearing on the Georgia disciplinary proceeding, Dr. Pennington called as witnesses on his behalf his then current employer, Mr. Rupert Heller, and his then wife, Kim Pennington. Mr. Heller testified that he had allowed Dr. Pennington to return to work at his pharmacy as a pharmacist. But the return was subject to certain conditions. The conditions included weekly random urinalyses, direct supervision by other pharmacists, no access to medications and lie-detector tests when requested. Mr. Heller also testified that Dr. Pennington was a competent, conscientious pharmacist who always performed well the duties of his employment. Kim Pennington testified that she had been unaware that Dr. Pennington had used drugs prior to the revelation of early 1985. She also testified about her involvement in Dr. Pennington's treatment program at Willingway, including spending five days at the facility to integrate her into his care and attendance at family counseling sessions. Persuaded by the testimony of Dr. Pennington, his employer and his wife, Kim, and recommendations by the Attorney for the Board, the hearing officer wrote the following in his Initial Decision: The State produced evidence through testimony and the Respondent produced evidence through testimony of witnesses that the Respondent made a mistake in his life and is coping with that mistake in an attempt to overcome his use of drugs and drug abuse. The Respondent moved on his own volition with the help of others to search out and take advantage of programs that would rehabilitate him with respect to overcoming ... drug abuse ... . The Hearing Officer was persuaded to consider any recommendations which were made by the Attorney for the Board in these matters due to the goodwill effort on behalf of the Respondent as well as the assistance and guidance that has been given to the Respondent b[y] said Respondent's present employer.... Exhibit No. 6 attached to Petitioner's Ex. No. 2. Georgia Discipline Following the hearing in Georgia and the initial decision of the hearing officer, the Georgia Board imposed a suspension of Dr. Pennington's license to practice pharmacy for six months, just as the hearing officer had initially decided. But further, again following the lead of the hearing officer's initial decision, the Board suspended enforcement of the suspension for two years during which Dr. Pennington was to be on probation with conditions. Among other conditions of the probation, Dr. Pennington was required to submit to random urinalyses and to attend professional aftercare treatment and counseling. The probationary period was set from December 1985 until December 1987. Medical School After being on probation for a period of eight months, Dr. Pennington, in August of 1986, entered a medical school in the Caribbean on the island nation of Grenada. Dr. Pennington requested the Board of Pharmacy that the conditions of probation be lifted while he was in medical school because of the difficulty in complying with them in Grenada. The request was granted. After his second year of medical school in Grenada, Dr. Pennington transferred to the Medical College of Georgia in Augusta, Georgia. While in medical school in Georgia, Dr. Pennington began working part-time as a pharmacist again. Dr. Pennington did not resume compliance with the conditions of probation imposed by the order of the Georgia Board of Pharmacy. As to its role in overseeing Dr. Pennington, the Georgia Board apparently simply lost track of his case. In any event, the Georgia Board did not follow up to ensure that Dr. Pennington had completed his probation successfully. Resumption of Drug Use During his third year of medical school, while working as a pharmacist again, Dr. Pennington began drinking. Before long, he was taking drugs from the pharmacy at which he was working for his own personal use, again without authorization from the pharmacy or a prescription. Following graduation from medical school, Dr. Pennington undertook his residency at the Ochsner Clinic in New Orleans. His drug use continued. But instead of taking drugs from a pharmacy inventory, Dr. Pennington opted for a method not subject to pharmacy inventories. He wrote prescriptions for them in the names of other persons. Access to More Powerful Narcotics as an Anesthesiologist Respondent began his residency in internal medicine but switched to anesthesiology. The switch was not helpful to Dr. Pennington in terms of controlling his addiction. Now, different drugs, often more powerful, were readily available to him. Among them was Sufenta. To narcotic addicts subject to monitoring who want to resume narcotic use, Sufenta is a drug of choice because it is difficult to detect in bodily fluids. Listed as a controlled substance under Schedule II, Section 893.03(2), Florida Statutes, Sufenta is used primarily for analgesia in surgery. In addition to eliminating physical pain, it produces feelings of well-being and stops emotional pain. It has an effect similar to hydrocodone but it is shorter-acting and much more potent. In fact, Sufenta is the most potent opiate used in medicine today. Dr. Pennington began using Sufenta while a resident in anesthesiology either by injecting it or by inhaling it nasally. His use of this extremely powerful narcotic continued throughout the first half of this decade. Application for Florida Licensure as an M.D. In July of 1993, Dr. Pennington's fiance, Rachel, (now his wife,) assisted him in filling out his application for licensure by the Board of Medicine. Just as Dr. Pennington's previous spouse and other family members had been unaware of his narcotic addiction while a pharmacist prior to entering medical school, Rachel Pennington, too, was unaware that Dr. Pennington was using narcotics. Moreover, she did not know of his past history of drug use or his discipline in Georgia. Rachel Pennington typed the application for Dr. Pennington. Questions 4, 9 and 10 on the application were these: Have you ever been notified to appear before any licensing agency for a hearing on a complaint of any nature, including, but not limited to, a charge or violation of the medical practice act, unprofessional or unethical conduct? Are you now or have you ever been addicted to or excessively used alcohol, narcotics, barbiturates, or any other medication? Have you ever voluntarily or otherwise been a patient in a hospital, institution, clinic or medical facility for the treatment of mental/ emotional illness, drug, addiction/abuse, or excessive use of alcohol? Although the correct answer to each of the three questions in Dr. Pennington's case is "yes," the answers he gave on the application to each were "no." Dr. Pennington reviewed and signed the application. At this moment of opportunity to reveal the truth to his fiancee, Dr. Pennington chose to continue to conceal his addiction and past history of both drug use and discipline. The falsified application was submitted to the Board of Medicine in November of 1993. During the hearing in this case, Dr. Pennington was asked on cross examination about his awareness that the application contained misrepresentations: Q You were aware at the time you filled out your licensure application that the answers to those three questions were incorrect, weren't you? A ... I don't think it is adequate to answer the question saying that because of my denial of the disease that I didn't know the question was wrong. I definitely, at some level, knew the question was wrong. Q ... You knew that you had been disciplined before?. A Yes. Q And you knew that you had been in a treatment facility before. A Yes. Q ... Did you consider that you were in a treatment facility because you were excessively using drugs? * * * A Well, I guess to answer that ... I have to say yes, at some level I definitely did. I was not willing to admit that but to answer your question I have to say yes. (Tr. 201). Practice in Florida and Continued Drug Use Dr. Pennington was licensed by the Board of Medicine on March 11, 1994. He continues to hold that license, license number ME 0065888. In June of 1994, Dr. Pennington completed his residency. Shortly thereafter, he moved to Florida to begin practice as an anesthesiologist. He continued to use narcotics. In order to stave off withdrawal symptoms, the onset of which can occur within several hours of using a powerful opiate like Sufenta, Dr. Pennington was forced to use narcotics throughout the day, including while at work. Moreover, he was unable from time-to-time to avoid the side effects of withdrawal, which included chills and diarrhea. To control those symptoms, he used drugs such as Lomotil. Lomotil, like Sufenta and the other opiates Dr. Pennington has used, requires a prescription. Self-prescribing and Fictitious Patients In order to obtain some of these drugs, Dr. Pennington wrote out prescriptions for Bob Pennington (his father), Rachel Pennington (his wife), and Kim Patrick (his ex-spouse), none of whom were patients of his. For example, between November, 1994, and February, 1995, he wrote or called in at least fourteen prescriptions for Hycodan, Lomotil and Tussionex, in the names of the three fictitious patients. In reality, the prescriptions were for himself. The Self-prescribed Medications Hycodan contains hydrocodone bitartrate, and is a Schedule III controlled substance under Section 893.03(3), Florida Statutes. It is used for cough-relief. The maximum recommended daily dose is 30 milliliters, or six tablets, which consists of thirty milligrams of hydrocodone. Tussionex contains hydrocodone polistirex, and is a Schedule III controlled substance under Section 893.03(3), Florida Statutes. It is used for cough relief and upper respiratory symptoms associated with allergies or colds. The maximum recommended daily dose is ten milliliters consisting of twenty milligrams of hydrocodone. Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. It is a narcotic with potential, of course, for abuse. It has the potential for abuse because it is an opiate derivative, one that, attached to the morphine or opiate receptor in the brain, produces effects of somnolence and euphoria, as well as suppressing other nerve impulses. Hydrocodone causes one to feel good about oneself, blurs time relationships, and changes a person's perceptions. It can cause lack of attention or cause one to be easily distracted, traits that pose extreme danger to patients under the care of an anesthesiologist. Once a certain level of tolerance is reached with hydrocodone, it causes twitching, nervousness, diarrhea, flushing, chills, goosepimples, and other classic symptoms of narcotics withdrawal. Lomotil contains diphenoxylate hydrochloride, and is a Schedule V controlled substance under Section 893.03(5), Florida Statutes. It is used in the management of diarrhea, a common symptom of narcotics withdrawal. It is also used to control other symptoms of withdrawal such as pain and twitching. The maximum recommended daily dose of Lomotil is eight tablets a day or twenty milligrams. At high doses, it is addictive, causing codeine-like effects. Between November, 1994, and March, 1995, Dr. Pennington was taking approximately 15-20 hydrocodone tablets, that is, 75- 100 milligrams, per day, and 30 to 50 Lomotil tablets or 75 to 125 milligrams per day. These levels of consumption are three to five times the recommended maximum daily dosage. Dr. Pennington was self-administering these substances for several purposes: satisfying his addiction, fending of withdrawal symptoms and controlling withdrawal symptoms he could not avoid. Caught Again On March 24, 1995, Dr. Pennington was questioned by an official of the Drug Enforcement Agency (DEA) and a Pinellas County Sheriff's Office detective regarding the fourteen prescriptions for fictitious patients written in late 1994 and early 1995. The interview took place immediately after Dr. Pennington had completed administering anesthesia during an operative procedure on a patient. Dr. Pennington admitted writing the fraudulent prescriptions. Furthermore, he provided the officers with a syringe containing approximately one cubic centimeter of Sufenta. Dr. Pennington admitted that he had used Sufenta about two hours earlier before administering anesthesia to the patient. Talbott-Marsh On March 25, 1995, the day after the DEA discovered Dr. Pennington was illegally using narcotics, he was admitted to the Talbott-Marsh Recovery System in Georgia, having been referred because of his chemical dependency by the Physicians Recovery Network. An inpatient chemical dependency treatment facility, Talbott-Marsh is specifically designed to meet the treatment needs of chemically addicted health care professionals, especially physicians. Five months after admission, on August 25, 1995, Dr. Pennington was discharged from Talbott-Marsh. He had completed the program successfully. Once again, just as upon successful completion of the program at Willingway, Dr. Pennington was in recovery from the disease of chemical dependency. Addiction: the Disease of Chemical Dependency The Disease and its Stages Chemical dependency or addiction is a chronic illness. An identifiable disease recognized by the medical profession, it is not the result of voluntary behavior. Rather, it is the result of a biogenetic defect, one with which the addicted person is born. Together with introduction into the person's system of a sufficient amount of a mood altering substance, this defect produces addiction. Initially, the disease manifests itself in abuse of the drug. In this early stage, addiction has not yet occurred. As use recurs, however, at some point the person crosses the threshold of addiction. After addiction, the individual becomes more and more preoccupied with obtaining the drug, primarily to avoid withdrawal symptoms when the addiction is not satisfied. The more preoccupied the individual becomes with obtaining the drug, the more avoidance there is of external responsibilities: those related to family, work and self. The disease is characterized by the continued use of the drug in the face of ongoing adversity as the result of the avoidance of external responsibilities. Left untreated, the disease leads to serious consequences: institutionalization due to a number of factors which may include brain damage or uncontrollability, disability, and, in extreme cases, death. Crossing the Wall As the disease progresses, eventually it takes control of not only the individual's use of the drugs but all of the individual's thinking as well. This point is referred by practitioners of addictionology as "crossing the wall." When the addict crosses the wall, the disease is in control. It is not uncommon for an addict who crosses the wall to conceal the drug use from everyone including spouse, other family members, friends, and employers. It is common for an addict who has crossed the wall to lie about drug use and minimize the extent of its effects on the addict's life. The acts of denying, concealing, and lying about drug use are common manifestations of the disease of chemical dependency. They fall into a continuum of symptoms of the disease ranging from denial, which relates to the negative consequences the use is having on the addict, to lying. Physicians as Addicts It is common for physicians addicted to drugs to steal them, divert them, write prescriptions for their own use or engage in other deceptive means of obtaining drugs. The manner used by physicians to obtain drugs is often dependent upon the physician's specialty. Nonetheless, self- prescribing medications is found in almost all of the cases of addicted physicians. Consuming massive quantities of drugs is not unusual for the addicted physician, often, in part, because of ready access to drugs. It is, moreover, a sign of tolerance of the drugs. Even in cases of great consumption, and despite the characteristics of narcotics and opiates, when physicians develop tolerance, they remain able to function well while under the influence of the substance. It is common, therefore, for drug usage to go undetected for long periods of time. Furthermore, with regard to opiates and narcotics, it is often difficult to determine whether a person is using them. There tends to be much less muscular coordination, slurred speech and recent memory deficits as would be observed of persons under the influence of other drugs. An individual addicted to and under the influence of opiates, even a physician practicing in a specialty as demanding as anesthesiology, can appear to be functioning as well as a person not under the influence of drugs. This is the case, in part, because a person addicted to opiates can develop tolerance rapidly. The more powerful the opiate, the sooner tolerance may be developed, as in the case of Sufenta. A physician under the influence of Sufenta can take a massive dose and appear to be basically normal to the untrained eye. Dr. Pennington's Stage of Addiction at the Time of Application Prior to the fall of 1993, that is, the time when Dr. Pennington made out and submitted his application to the Board of Medicine, he exhibited all the symptoms of a person who has crossed the wall. He had concealed his drug use, which at that time had become quite advanced, from his fiancee, his family, friends, and colleagues. He was taking massive quantities of narcotic opiates, yet, to the untrained eye, he was not exhibiting symptoms of a person under the influence. At the time of application, Dr. Pennington was well- thought of by his colleagues in the residency program in Louisiana. He was highly recommended for licensure to the Board of Medicine by the instructors of his residency training program. Treatment, Care and Aftercare Treatment is an important phase of the recovery process. Those suffering chemical dependency generally do well in treatment because of the controlled and structured nature of the treatment environment. The environment is safe. The patient is surrounded by others with similar problems. There is a lot of support both from those suffering the disease as well as from professionals. A successful treatment program must insist that the patient be rigorously honest in order to attain full recovery. Rigorous Honesty Because lying is an integral part of the disease of chemical dependency, a program of recovery demands rigorous honesty. In an effective recovery program, such as the one Dr. Pennington participated in at Talbott-Marsh, the physician is required to face the consequences of addiction and participate in psychotherapy when needed. During the treatment phase, the physician is required to go through identification with the family, have a fourth and fifth step of identifying the history of past defects and telling them to another human being. The Physician Recovery Network The Physician Recovery Network is the program used by the Board of Medicine to monitor physicians impaired by addiction in the State of Florida under Section 455.261, Florida Statutes. The Physician Recovery Network ("PRN,") assists the physician in developing and maintaining a manner of living which demands rigorous honesty. PRN does this by requiring the physician to enter into an Advocacy Contract, a five year contract that can be extended if necessary. The Advocacy Contract is designed to serve as a deterrent, promote honesty, to verify through face-to-face conferences and monthly and weekly meetings and periodic urine screens, that a physician is progressing or improving and is not endangering the public or him or herself. Physicians are required to identify the consequences of their drug use and admit their powerlessness over their ability to stop using drugs. Rigorous honesty is demanded by PRN from its participants because it is absolutely required in order to break denial and to prevent rationalization and denial from returning to the behavioral patterns of the addicted physician. PRN educates physicians about the negative behavioral patterns of their disease and monitors the physicians for the return of erratic behavior or evidence of returning denial or evidence of lying. PRN educates physicians about their own indicators for relapse so that they avoid positions likely to produce relapse and so that they will not be unconsciously driven to resume drug use to relieve personal discomfort. PRN monitors its physician participants through local group facilitators. Monitors are assigned because of geographic proximity that will allow immediate access in order to provide counseling. Initially, the PRN monitor undertakes a direct physical evaluation of the physician and becomes familiarized with the physician's specific problems to allow early identification of developing problems that would endanger the public or the physician. In addition, the monitor maintains close contact with PRN. Reports to PRN are made at least weekly providing information about general progress, insight, attentiveness, responsiveness to urine screens, participation in group sessions, openness of the physician, assessment of honesty, and assessment of coping skills. The contact between the monitor and PRN is so comprehensive that it can be characterized as an ongoing dialogue about all aspects of the physician related to management of the addiction and the medical-legal implications for the physician's practice and protection of the public. The monitor is also charged with providing the participating physician with support. If a physician fails to comply with PRN instructions or relapses, the monitor immediately reports it to PRN so that the physician can be submitted to treatment. If necessary to protect the public in such a case, PRN does not hesitate to report the matter to the Agency for Health Care Administration for entry of an emergency order suspending the license. While some number below 20 percent of physicians who enter PRN require more than one treatment to become firmly committed to recovery, 97 percent of the physicians who enter PRN practice without difficulty after five years. The ninety-seven percent success rate PRN has experienced with addicted physicians is significantly higher than the success after treatment of the general population of sufferers of chemical dependency in returning to lives committed to recovery and free of the problems of addiction. Aftercare Aftercare, the stage of recovery which follows treatment and the diseased physician's entry into recovery, is an essential phase of the recovery process, every bit as important, if not more so, than the initial program of treatment. It must consist of close monitoring with repetitive follow-up. This is provided by PRN. As an aftercare program more highly developed than the aftercare received by Dr. Pennington from Willingway in the previous decade, in part, due to advances in the study of addictionology, PRN provides the type of aftercare that supports recovery as fully as possible in light of the status of addictionology today. For example, the syndrome of "protracted withdrawal from opiates," was not even known to exist at the time Dr. Pennington participated in the Willingway program. The syndrome is the result of the body shutting off its own, natural, manufacture of endorphins and other "internal opiates," necessary to a sense of well-being while taking narcotic opiates and introducing into the body exogenous opiates. As a result, it takes the body several years, a period longer than the initial treatment phase, to begin producing its own internal opiates. In the meantime, the opiate addict will continue to suffer withdrawal symptoms, hence the term "protracted" withdrawal. Unlike the care after the Willingway program, the PRN aftercare program provides treatment for protracted withdrawal. Dr. Pennington's Experience with PRN and Adherence to the Advocacy Contract At least through the time of hearing, Dr. Pennington has maintained a strict adherence to his PRN contract. He has fully complied with monitoring by PRN. He has shown a significant commitment to his program of recovery since entering into the advocacy contract. Since late summer, 1995, PRN has considered Dr. Pennington to be safe to practice under the terms of his advocacy contract with continued monitoring. In making that determination, PRN has considered all of the Respondent's past addictive behavior including the length of his addiction, his ability to function normally while under the influence of opiates and other drugs, lying about drug use, concealing it from family, friends, work colleagues, even the Board, stealing drugs, and self-prescribing. Moreover, PRN has considered his prior discipline by the Georgia Board of Pharmacy, the treatment at Willingway and the failed aftercare in his first effort at recovery. Most importantly, PRN has considered the potential danger Dr. Pennington poses to patients and the public. Because of restrictions imposed upon him by both Talbott-Marsh and PRN, Dr. Pennington is not practicing as an anesthesiologist. He cannot resume that practice until his treatment professionals and PRN agree that it is safe for him to do so. Dr. Pennington is not permitted access to controlled substances. He must utilize triplicate prescriptions, one for the patient, one in the chart, and the other for monitoring. Since leaving Talbott-Marsh, Dr. Pennington has successfully met these requirements imposed for his aftercare from the moment he left Talbott-Marsh: Monitor and addictionologist: Dr. Roger Goetz and a local monitor, Jim Noyes, Ph. D. Primary physician of Marte Kautzler, D.O. Not to return to anesthesiology for at least one year following treatment. Return to Talbott-Marsh for reassessment. Work 40 hours per week maximum. Utilize triplicate prescription pads in his practice. Reside with wife, Rachel, and attend couples therapy as directed by Dr. Noyes. Attend Caduceus and AA, 90 meetings in 90 days, followed by attending at a frequency of four to seven times per week. See Joint Exhibit 1. Board Action Had it Been Aware of the Truth at the Time the Application Was Filed Had the Board been aware at the time Dr. Pennington filed his application that the answers to questions 4, 9 and 10 were inaccurate, Dr. Pennington would have had to appear before the Board's Credential Committee. The Committee would have required a personal appearance of Dr. Pennington and a PRN evaluation. Based on the evaluation and Dr. Pennington's explanation for the inaccuracies in the application, the Committee would have recommended either denial of licensure or issuance of the license. Dr. Pennington is in full compliance with his PRN contract and has demonstrated a strong commitment to his program of recovery and the requirements of PRN. It is likely, based on an analysis of similar cases, that if Dr. Pennington were to apply for a license today, with full disclosure, and under the current circumstances of his good standing in the PRN program, that the Board would grant him a license with conditions. Dr. Pennington's Practice Today Today, Dr. Pennington is employed as a practicing physician at a private walk-in clinic. In addition to the practice of requiring his prescriptions in triplicate, his access to controlled substances is completely restricted and the restriction is closely monitored. The nurses at the clinic maintain the keys which allow access to the drugs. An inventory is conducted in the morning when the facility opens and is matched every day with an inventory done in the evening when the facility closes. A urinalysis to check for recent drug use was performed when Dr. Pennington was hired and random urinalyses are done of all employees, including the owner, from time to time without warning. Dr. Pennington, at the time of hearing, had been subject to two urinalyses. Dr. Pennington is observed at the facility for behaviors that would indicate relapse. At the time of hearing, he had not exhibited any such behaviors. His knowledge of medicine was described by his employer as good. Moreover, Dr. Pennington has shown good clinical judgment in the cases he has encountered as well as excellent skills in dealing with his patients. The Impact of Discipline on Dr. Pennington It would be counter-therapeutic to Dr. Pennington to remove him from the practice of medicine while he is in recovery. In fact, one of the main reasons for the extremely high success rate of PRN's work with physicians suffering from the disease of chemical dependency when compared to the general population of those with the disease, is that the physician is working and his or her license is always at stake. Protection of the Public The department, in an attempt to protect the public, is seeking discipline of Dr. Pennington. Yet, the Board, by not taking emergency action against his license, has conceded that he is not impaired at the moment and so long as he is in recovery. Moreover, by allowing his practice pending this proceeding and not taking emergency action against his license, the Board has determined Dr. Pennington's practice as a physician in a walk-in clinic does not pose an imminent danger to public health safety and welfare.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That Dr. Pennington's license to practice medicine be suspended for five years; That the suspension be stayed and that he be placed on probation immediately for at least five years with probation to be extended, if necessary at the end of the five years; That appropriate conditions of the suspension be imposed by the Board to include, at a minimum: No practice of anesthesiology during the period of probation; No access to controlled substances, drugs or medicines requiring a prescription during the period of probation; and, Participation in the Physician's Recovery Network for the entire period of probation. DONE AND ENTERED this 22nd day of November, 1996, in Tallahassee, Leon County, Florida. DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of November, 1996. COPIES FURNISHED: Monica Felder, Esquire Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399 Grover C. Freeman, Esquire Jon M. Pellett, Esquire Freeman, Hunter & Malloy 201 East Kennedy Blvd., Suite 1950 Tampa, Florida 33602 Dr. Marm Harris Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact At all times relevant hereto, William E.P. Shaw was licensed as a pharmacist in the State of Florida, having been issued license number 0008802. On January 21, 1986, Respondent, in the United States District Court for the Northern District of Georgia, pleaded guilty and was convicted of the offense of conspiracy to obtain drugs at a low purchase price under false and fraudulent pretenses and representations to various drug manufacturers that drugs were for use in Palms of Pasadena Hospital, St. Petersburg, Fla., which drugs were then diverted from said hospital use and resold at substantial profit, this being done by use of interstate Wire Communications and the U.S. Mail - all in violation of Section 1343, and 1341 and 2 - Title 18, and 371 - Title 18, U.S.C., as charged in the within indictment. (Exhibit 1). At the time of the alleged offense, Respondent was a staff pharmacist at Palms of Pasadena Hospital. Prior thereto he headed a company or group which managed several hospital pharmacies including that of Palms of Pasadena. His contract with Palms of Pasadena Hospital expired in 1984 and was not renewed. Drug manufacturers sell drugs to hospitals at a much lower price than they sell to wholesalers. Respondent set up an account on which the hospital comptroller had check writing authority, and as a pharmacist ordered specific drugs under the hospital's drug account number to be delivered to the hospital. Upon arrival at the hospital these drugs were immediately reshipped to a contact in Miami, who was a licensed drug wholesaler, or to a contact in Atlanta, who was not so licensed. To the hospital's price for the drugs, which was paid by the hospital's comptroller from the account established by Respondent, Respondent added ten percent. This sum was remitted to him by these two purchasers and the account from which the supplier was paid was reimbursed. Respondent testified that he was unaware that his scheme was in violation of the law; however, Respondent was aware that he was defrauding the drug companies and violating the hospital's agreement with these companies to dispense all drugs purchased only to hospital patients. Drugs so ordered and resold by Respondent were primarily prescription drugs slow-K and nitro patches. Following his conviction in the U.S. District Court Respondent was sentenced to three years imprisonment the execution of which was suspended and Respondent was placed on probation for three years, ordered to pay a fine of $7,500.00 and perform 400 hours of community service work (Exhibit 1). At the time of this hearing, Respondent had satisfied the sentence but for the unexpired probation. Respondent has been a licensed pharmacist since 1958 and, but for the federal charge and conviction, has enjoyed a good reputation in the field of pharmacy and in the community in which he lived.
