STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, Case Number 2011-15575 PHARMACY ONE, INC.,, RESPONDENT. / ADMINISTRATIVE COMPLAINT Petitioner, Department of Health, by and through the undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy against Pharmacy One, Inc., and in support alleges: 1. Petitioner is the state agency charged with regulating pharmacies pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 465, Florida Statutes. 2. At all times material to this Complaint, Respondent was a permitted community pharmacy within the State of Florida, having been issued permit number PH 17820, 3. At all times material to this Complaint, Respondent’s address of record was 2505 Northwest 54" Street, Miami, Florida 33142. 4, At all times material to this Complaint, Respondent was also doing business as Robert’s Drug Store #3. 5. At all times material to this Complaint, Respondent was one of four pharmacies (doing business as Robert’s Drug Store #1, Robert’s Drug Store #2, and Robert’s Drug Store #4) that were owned, operated or associated, in whole in or in part, by or with Aiman Aryan (PS 33142), who was a pharmacist. Filed December 9, 2011 11:59 AM Division of Administrative Hearings 6. In 2010 and 2011, Respondent dispensed the opiates oxycodone, Oxycontin and Opana, 7 Opioid, or opiate, drugs have similar actions as the drug opium and are typically prescribed to treat pain. Opioid drugs are synthetically manufactured, while opiate drugs are naturally occurring, but the terms opioid and opiate are often used interchangeably. Opioid drugs are addictive and subject to abuse and diversion. 8. Oxycodone is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States, according to Section 893.03(2), Florida Statutes (2009-2011). Abuse of oxycodone may lead to severe psychological or physical dependence, 9. Oxycontin the brand name of a controlled release formulation. of oxycodone and | is a schedule II controlled substance, according to Section 893.03(2), Florida Statutes (2009- 2011). Oxycontin is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States. Abuse of oxycodone may lead to severe psychological or physical dependence, 10. Opana is the brand name for the drug oxymorphone hydrochloride. According to Section 893,03(2), Florida Statutes (2009-2011), oxymorphone hydrochloride is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States, Abuse of oxymorphone may lead to severe psychological or physical dependence, iL Between on or about January 1, 2011, and on or about June 30, 2011, Respondent purchased approximately 790,300 units of oxycodone or oxycodone derivative drugs. Page 2 of 8 12. Between on or about J anvary 1, 2011, and on or about June 30, 2011, Respondent purchased more oxycodone or oxycodone derivative drugs than any other pharmacy in the Miami-Dade county area. 13. In 2010 and 2011, the Respondent filled prescriptions for patients of Dr. FB. The majority of F.B.’s patients had prescriptions for 90 tablets of Oxycontin 80 mg and 180 tablets of oxycodone 30 mg that they were filling for the first time at the Respondent. 14, Approximately 420 mg oxycodone per day is a lethal dose for a patient that has not been exposed to opiates previously. 15. From on. or about June 20, 2010, through on or about October 2010, Respondent filled approximately 308 prescriptions written by F.B., which totaled approximately 32,520 units of oxycodone and/or Opana. 16, . From on or about April 7, 2011, through on or about August 17, 2011, Respondent dispensed approximately 9,130 units of oxycodone and/or Opana, as prescribed by FB. 17, Of the 9,130 units of oxycodone and/or Opana prescribed by F.B,. from on or about April 7, 2011 through on or about August 17, 2011, approximately 41 presctiptions were for oxycodone 30 mg; approximately 39 of those prescriptions were written for an identical amount of 180 tablets of oxycodone and approximately 30 prescriptions were written for an identical amount of 60 tablets of Opana 40 mg. 18. From on or about April 7, 2011 through on or about August 17, 2011, Respondent filled approximately 27 identical prescriptions for a combination of 60 units of Opana 40 mg and 180 oxycodone 30 mg, as prescribed by F.B. Page 3 of 8 19, The dispensing records of Respondent and the related Robert’s pharmacies were remarkable because of the similarities of the medication being prescribed by the same physician (F.B.) for large quantities of narcotics to hundreds of patients. 20, Dispensing or distributing legend drugs in excessive or inappropriate quantities is not in the best interest of a patient. , 21, Dispensing or distributing legend drugs in excessive or inappropriate quantities is not in the course of the professional practice of pharmacy. 22. One or more affiliated person, partner, officer, director, or agent of the Respondent knew or should have known that prescriptions for large number of opiates written by F.B. were excessive and inappropriate. By filling F.B.’s prescriptions, one or more affiliated person, partner, officer, director, or agent. of the Respondent were not engaged in the professional practice of pharmacy. 23, ° Apharmacy presented with prescriptions for large quantities of the same narcotics written by the same physician should contact the prescriber to verify the validity of the prescriptions. 24. By continuing to fill similar prescriptions from the same physician for large quantities of opiates, Respondent was dispensing opiates outside the legitimate practice of pharmacy. Count I 25, Petitioner realleges and incorporates paragraphs 1 through 24, as if fully set forth. 26. Section 465.023(1)(c), Florida Statutes (2009-2011), provides that a permittee is subject to discipline for violated any of the requirements of chapter 465 or any of the rules of the Board of Pharmacy; of chapter 499, known as the “Florida Drug and Cosmetic Act’; of 21 Page 4 of 8 U.S.C, ss. 301-392, known as the “Federal Food, Drug, and Cosmetic Act”; of 21 U.S.C. ss, 821 et seq., known as the Comprehensive Drug Abuse Prevention and Control Act; or of chapter 893. 27. Section 465.023(1)(h), Florida Statutes (2009-2011), provides that the Department may discipline the permit of any pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee, dispenses any medicinal drug based on upon a communication that purports to be a prescription as defined by Sections 465,003(14) or 893.02, Florida Statutes (2009-2011) when the pharmacist knows or has reason to believe that the purported prescription is not based upon a valid practitioner-patient relationship that includes a documented patient evaluation, including a history and a physical examination adequate to establish the diagnosis for which any drug is prescribed and any other requirement established by board rule under Chapters 458, 459, 461, 463, 464, or 466, Florida Statutes (2009-2011). 28. Respondent dispensed large quantities of controlled drugs when one or more affiliated person, partner, officer, director, or agent of the Respondent, knew or had reason to believe that the purported prescriptions were not based upon valid practitioner-patient relationships in one or more of the following manners: a By filling prescriptions written by F.B. for 90 tablets. of Oxycontin 80 mg and 180 tablets of oxycodone 30 mg for first time clients in 2010 and 2011. One or more affiliated person, partner, officer, director, or agent of the Respondent, knew or should have known that 420 mg oxycodone per day is a lethal dose for a patient that has not been exposed to opiates previously. db. ) By dispensing 32,520 units of oxycodone or oxycodone derivative drugs that F.B, prescribed between June and October 2010; and/or Page 5 of 8 c By dispensing 9,130 units of oxycodone or oxycodone derivative drugs to patients of F.B. between on or about April 7, 2011, and on or about August 17, 2011; and/or d. By dispensing approximately 27 identical prescriptions for 60 units of Opana 40 mg and 180 oxycodone 30 mg, to patients of F.B from on or about April 7, 2011 through on or about August 17, 2011. 29. Based on the foregoing, Respondent violated Section 465.023(1)(c), Florida Statutes (2009-2011), by violating section 465.023(1)(h), Florida Statutes (2009-2011), by dispensing medicinal drugs based on upon communications that purported to be prescriptions as defined by Sections 465.003(14) or 893.02, Florida Statutes (2009-2011), when one or more affiliated person, partner, officer, director, or agent of the Respondent knew or had reason to believe that the purported prescriptions were not based upon valid practitioner-patient relationships. Count 30. Petitioner realleges and incorporates paragraphs 1 through 24 as if fully set forth, 31, Section 465.023(1)(c), Florida Statutes (2009-2011), provides that a permittee is subject to discipline for violated any of the requirements of chapter 465 or any of the rules of the Board of Pharmacy; of chapter 499, known as the “Florida Drug and Cosmetic Act”: of 21 USC. ss. 301-392, known as the “Federal Food, Drug, and Cosmetic Act”; of 21 U.S.C, ss, 821 et seq., known as the Comprehensive Drug Abuse Prevention and Control Act; or of chapter 893. 32. Section 465.016(1)(i), Florida Statutes (2009-2011), provides that compounding, dispensing, or distributing a legend drug, including any controlled: substance, other than in the course of the professional practice of pharmacy constitutes grounds for disciplinary action. For the purposes of this section, it shall be legally presumed that the compounding, dispensing, or Page 6 of 8 | j fo icumen. distributing of legend drugs in excessive or inappropriate quantities is not in the best interests of the patient and is not in the course of the professional practice of pharmacy. 33. Respondent compounded, dispensed, or distributed legend drugs, including controlled substances, other than in the course of the professional practice of pharmacy, in the one or more of the following manners: a By filling prescriptions written by F.B. for 90 tablets’ of Oxycontin 80 mg and 180 tablets of oxycodone 30 mg for first-time clients in 2010 and 2011, One or more affiliated person, partner, officer, director, or agent of the Respondent, knew or should have known that 420 mg oxycodone per day is a lethal dose for a patient that has not been exposed to opiates previously. . b. By dispensing approximately 27 identical prescriptions for 60 units of Opana 40 mg and 180 oxycodone 30 mg, to patients of F.B from on or about April 7, 2011 through on or about August 17, 2011 c. By dispensing excessive and/or inappropriate quantities of oxycodone or oxycodone derivative drugs; and/or d. By dispensing excessive and/or inappropriate quantities of Opana ER; and/or 34, Based on the foregoing, Respondent violated Section 465,023(1)(c), Florida Statutes (2009-2011), by violating Section 465.016(1)(i), Florida Statutes (2009-2011), by compounding, dispensing or distributing a legend drug, including any controlled substance, other than in the course of the professional practice of pharmacy. WHEREFORE, Petitioner respectfully requests that the Board of Pharmacy enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent’s permit, restriction of practice, imposition of an administrative fine, issuance of a Page 7 of 8 reprimand, placement of the Respondent on probation, corrective. action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. SIGNED this_3/ Stay of bE t-nert 2011, H. Frank Farmer, Jr., M.D., Ph.D., RA.C.P. State Surgeon General Gace Kher FILED TH ‘Grace Kim DEPARTMENT OF HEAL Assistant General Counsel DES nders DOH Prosecution Services Unit CLERK Ange O11 4052 Bald Cypress Way, Bin C-65 pate 10/31/2 Tallahassee, FL 32399-3265 Florida Bar # 31096 (850) 245-4640, Ext. 8187 PHONE (850) 245-4662 FAX IGK PCP: October 31, 2011 PCP Members: Lorena Risch, Pharm.D, and Michelle Weizer, Pharm.D. NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested, NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this matter, Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed. Page 8 of 8

Docket for Case No: 11-006245