v.
COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy against Respondent, Aiman I. Aryan, and in support thereof alleges:
Petitioner is the state department charged with regulating the practice of pharmacy pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 465, Florida Statutes.
At all times material to this Complaint, Respondent was a licensed pharmacist within the State of Florida, having been issued license number PS 33142.
At all times material to this Complaint, Respondent's address of record was 590 West Flagler Street, Miami, Florida, 33130.
At all times material to this Complaint, Respondent owned, operated
Filed January 12, 2012 3:41 PM Division of Administrative Hearings
and practiced at Izz & Sons's Inc. (lzz & Sons), a community pharmacy that held permit number PS 33142 and DEA pharmacy registration number BI5793395.
Respondent entered into an arrangement with Dr. F.B. and other
individuals to distribute and divert controlled substances.
In particular, individuals (sponsors) would recruit purported patients to obtain drug prescriptions from Dr. F.B.
The sponsor would coach the patient as to what symptoms to allege to Dr.F.B.
With knowledge of this arrangement, Dr. F.B. would then prescribe large amounts of controlled substances, including Oxycontin, oxycodone and/or Opana ER, to the patient without a medical necessity.
Oxycodone is commonly prescribed to treat pain. Oxycodone is an opioid drug, which has similar effects as the drug opium. 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. According to Section 893.03(2)(a), Florida Statutes (2009- 2011), oxycodone, or any salt, compound, derivative, or preparation of 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. Abuse of oxycodone may lead to severe psychological or physical
dependence.
Oxycontin 1s a brand name of oxycodone hydrochloride and is prescribed to treat pain. Oxycontin is an extended-release medication used to provide pain relief for extending periods of time, while oxycodone is an immediate-release medication used to provide short-term pain relief. According to Section 893.03(2)(a), Florida Statutes (2009-2010), oxycodone, or any salt, compound, derivative, or preparation of 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. Abuse of oxycodone may lead to severe psychologicai or physical dependence.
Opana ER is a brand of oxymorphone hydrochloride, a morphine-like opioid agonist, and is prescribed to treat pain. Opana ER is similar to Oxycontin in that it is an extended-release medication used to provide pain relief over an extended period of time. According to Section 893.03(2), Florida Statutes (2011), oxymorphone 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 physi<:al dependence.
After obtaining the prescription, the sponsor would contact Respondent, who directed the sponsor and patient to one of his four pharmacies, at
which time the pharmacy would dispense the prescribed drugs to the patient.
Respondent would receive cash from the sponsor to process and fill the prescriptions without scrutiny, and the patient would then provide the sponsor with the drugs in exchange for $600.
Between on or about June 1, 2010, and on or about December 1, 2010, Respondent dispensed approximately 28,880 tablets of Oxycontin 80 mg, approximately 4,260 tablets of Opana ER 40 mg and 6 approximately 7,968 tablets of oxycodone 30 mg, all of which were prescribed by Dr. F.B.
Of those prescriptions, Respondent dispensed or had dispensed a combination of Oxycontin 80 mg and oxycodcme 30 mg on 303 occasions.
Beginning on or about October 7, 2010, and continuing until on or about October 25, 2010, Dr. F.B. began prescribing a combination of Opana ER 40 mg and oxycodone 30 mg, a combination which Respondent dispensed or had dispensed on approximately 71 occasions during that time period.
Similarly, between on or about March 9; 2011, and on or about September 28, 2011, Respondent dispensed or had dispensed a combination of Opana ER 40 mg and oxycodone 30 mg, all of which were prescribed by Dr. F.B., on apl?roximately 221 occasions.
Although the quantities of drugs dispensed between June 1 2010, and September 28, 2011, varied, Respondent routinely dispensed or had dispensed a
combination of 60-90 tablets of Oxycontin 80 mg/ Opana ER 40 mg and 120-180 tablets of oxycodone 30 mg to individual patients.
Thus, each purported patient received a minimum of 280 mg of oxycodone per day if he or she received the oxycodone-Oxycontin combination, or a minimum of 200 mg of oxycodone per day if he or she received the oxycodone Opana ER combination.
Respondent knew or should have known that the prescription medications dispensed were excessive and/or inappropriate.
Respondent knew or knew or had reason to believe that the prescription medications dispensed were not based upon a valid practitioner-patient relatinship.
Respondent knew or should have known that Dr. F.B. was engaged in diversion of controlled substances.
Respondent dispensed controlled substances· that are not in patients' best interest and were not in the normal course of the practice of pharmacy.
.: COUNT ONE
Petitioner realleges and incorporates paragraphs 1 through 23 as if fully set forth herein.
Section 465.016(1)0), Florida Statutes (2009-2011), allows the Board of Pharmacy (Board) to discipline or suspend the license of a pharmacist for
compounding, dispensing or distributing a legend drug, including any controlled substance, other than in the course of the professional practice of pharmacy. For purposes of this paragraph, it shall be legally presumed that the compounding,
dispensing or distributing of legend drugs in excessive or inappropriate quantities
:1 is not in the best interests of the patient and is not in the course of the professional practice of pharmacy.
Respondent dispensed or distributed controlled substances m excessive or inappropriate quantities in one or more of the following manners:
By dispensing excessive or inappropriate quantities of oxycodone 30 mg;
By dispensing excessive or inappropriate quantities of Oxycontin 80 mg;
By dispensing excessive or inappropriate quantities of Opana ER40mg;
By dispensing combinations of excessive or. inappropriate
quantities of combinations of oxycodone 30 mg and Oxycontin 80 mg; and/or
By dispensing combinations of excessive or inappropriate quantities of combinations of oxycodone 30 mg and Opana 40 mg.
Based on the foregoing, Respondent has violated Section
465.016(1)(i), Florida Statutes (2009-2011), by compounding, dispensing, or distributing legend drugs, including controlled substances, other than in the course of the professional practice of pharmacy.
COUNT TWO
Petitioner realleges and incorporates paragraphs 1 through 23 as if fully set forth herein.
Section 465.016(l)(s), Florida Statutes (2009-2011), allows the Board to discipline or suspend the license of a pharmacist for dispensing any medicinal drug based upon a communication that purports to be a prescription as defined by Sections 465.003(14) and 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.
Respondent was engaged in an arrangement with Dr. F.B. and other individuals, whereby Respondent would dispense prescription medications prescribed by Dr. F.B. for non-medical purposes.
Respondent dispensed controlled substances based upon purported
. .
. prescriptions when he knew or had reason to believe that the purported prescr.iptions were not based upon a valid practitioner-patient relationship, in one
or more of the following manners:
In his dispensing of oxycodone prescribed by Dr. F.B.;
In his dispensing of Oxycontin 80 mg prescribed by Dr. F.B.;
In his dispensing of Opana ER 40 mg prescribed by Dr. F.B.;
In his dispensing of combinations of oxycodone 30 mg and Oxycontin 80 mg prescribed by Dr. F.B.; and/or
e. In his dispensing of combinations of oxycodone 30 mg and Opana ER 40 mg prescribed by Dr. F.B.
Based on the foregoing, Respondent violated Section 465.016(l)(s), Florida Statutes (2009-2011), by dispensing any medicinal drug based upon a communication that purports to be a prescription as defined by Sections 465.003(14) and 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.
ri'
i COUNT THREE
Petitioner realleges and incorporates paragraphs 1 through 23 as if fully set forth herein.
Section 465.016(l)(r), Florida Statutes (2009-2011), allows the Board to discipline or suspend the license of a pharmacist for violating any provision of Chapters 456 or 465, Florida Statutes (2009-2011), or any rules adopted pursuant thereto.
Rule 64B16-27.831(5), Florida Administrative Code, sets forth the
standards of practice for the dispensing of controlled substances for treatment of
,
pain, in part, as follows:
;1
Any pharmacist who has reason to believe that a prescriber of controlled substances is involved in the diversion of controlled substances shall report such prescriber to the Department of Health.
Respondent had reason to believe Dr. F.B. was involved m the diversion of controlled substances.
Respondent failed to report Dr. F.B. to the Department.
Based on the foregoing, Respondent violated Section 465.016(1)(r), Florida Statutes (2009-2011), by violating any provision of Chapters 456 or 465, Florida Statutes (2009-2011), or any rules adopted pursuant thereto.
COUNTFOUR
Petitioner realleges and incorporates paragraphs 1 through 23 as if fully set forth herein.
Section 465.016(1)(r), Florida Statutes (2009-2011), allows the Board to discipline or suspend the license of a pharmacist for violating any provision of Chapters 456 or 465, Florida Statutes (2009-2011), or any rules adopted pursuant thereto.
Rule 64B16-27.104(3), Florida Administrative Code, provides:
No pharmacist or pharmacy, or employee or agent thereof, shall enter into or engage in any agreement or arrangement with any physician or other practitioner or nursing home or extended care facility for the
payment or acceptance of compensation in any form or type for the recommending of the professional services of either; or enter into a rebate or percentage rental agreement of any kind, whereby in any way a patient's free choice of a pharmacist or pharmacy is or may be limited.
Respondent and/or his employees entered into an arrangement with Dr. F.B. to fill prescriptions from Dr. F.B.'s patients for a fee.
Respondent's arrangement with Dr. F.B. may have limited the patients' free choice of a pharmacy.
Based on the foregoing, Respondent has violated Section 465.016(1)(r), Florida Statutes (2009-2011), by violating any provision of Chapters 456 or 465, Florida Statutes (2009-2011), or any rules adopted pursuant thereto.
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 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.
.. sr
H. Frank Farmer, Jr., M.D., Ph.D., F.A.C.P.
avm . Burge Assistant Gene I Couns Florida Bar No.
PCP Members: Lorena Risch, Phann. D., Michele Weizer, Phann. 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.
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 any other discipline imposed.
