STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, V. CASE NO. 2012-07512 PRIME SYNERGY, LLC, D/B/A CURE-AID PHARMACY, RESPONDENT. / ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy against Respondent, Prime Synergy, LLC, d/b/a Cure- Aid Pharmacy, and in support thereof alleges: 1. Petitioner is the state agency charged with regulating the practice of pharmacy pursuant to Section 20.43, Florida Statutes (2012), and Chapters 456 and 465, Florida Statutes (2012). 2. At all times material to this Complaint, Respondent was permitted to operate as a community pharmacy within the State of Florida, having been issued permit number PH 25086. 3. Respondent’s address of record is 7333 Lake Underhill Road, Orlando, Florida 32822. 4. At all times material to this Complaint, Ramesh J. Pathak, R.Ph. (“Mr. Pathak”), was licensed to practice as a pharmacist in the State of Florida pursuant to Chapter 465, Florida Statutes (2012). 5. At all times material to this Complaint, Mr. Pathak was the prescription department manager and only pharmacist employed at Respondent. 6. At all times material to this Complaint, Respondent was owned by Mr. Pathak’s wife, M.J., and sister-in-law, H.J. 7. ~ At all times material to this Complaint, Respondent operated as a community pharmacy in Orlando, Florida. Facts Specific to Patient N.C. 8. On or about March 4, 2011, Patient N.C. presented three prescriptions to Mr. Pathak at Respondent. 9. The prescriptions, written by Dr. A.W., were for 30 diazepam 10 mg, 180 oxycodone 30 mg, and 90 carisoprodol 350 mg. 10. Mr. Pathak dispensed the medications pursuant to each prescription. DOH v. Prime Synergy, LLC Page 2 of 21 DOH Case Number 2012-07512 11. Diazepam, commonly known by the brand name Valium, is prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes (2010-2011), diazepam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use in treatment in the United States. Abuse of diazepam may lead to limited physical or psychological dependence relative to substances in Schedule III. 12. Oxycodone is commonly prescribed to treat pain. According to Section 893.03(2), Florida Statutes (2010-2011), 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. 13. Carisoprodol, commonly known by the brand name Soma, is a muscle relaxant commonly prescribed to treat muscular pain. According to Section 893.03(4), Florida Statutes (2010-2011), carisoprodol is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use in treatment in the United States. Abuse of carisoprodol may lead to limited DOH v. Prime Synergy, LLC Page 3 of 21 DOH Case Number 2012-07512 physical or psychological dependence relative to the substances in Schedule III. 14. On or about March 18, 2011, Patient N.C. presented three prescriptions to Mr. Pathak at Respondent. 15. Although all three prescriptions purported to be written by Dr. A.W., they were actually written by Patient N.C. 16. The prescriptions were for 90 tramadol 50 mg, 210 oxycodone 30 mg, and 90 Soma 350 mg. 17. Mr. Pathak dispensed the medications pursuant to each prescription without first attempting to verify the prescriptions. 18. Tramadol, commonly known by the brand name Ultram, is an opioid class medication prescribed to treat pain. Tramadol is a legend drug, but not a controlled substance. Tramadol, like ali opioid drugs, can affect mental alertness, is subject to abuse, and can be habit forming. 19. On or about March 24, 2011, Patient N.C. presented three prescriptions to Mr. Pathak at Respondent. 20. Although ail three prescriptions purported to be written by Dr. V.S., they were actually written by Patient N.C. DOH v. Prime Synergy, LLC Page 4 of 21 DOH Case Number 2012-07512 21. The prescriptions, which were dated March 23, 2011, were for 30 Xanax 2 mg, 30 Ibuprofen 800 mg, and 210 oxycodone 30 mg. 22. Mr. Pathak dispensed the medications pursuant to each prescription without first attempting to verify the prescriptions. 23. Xanax is the brand name for alprazolam and is prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes (2010- 2011), alprazolam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use in treatment in the United States. Abuse of alprazolam may lead to limited physical or psychological dependence relative to the substances in Schedule ITI. 24. Ibuprofen is a non-steroidal anti-inflammatory drug and is used to reduce fever and treat pain or inflammation. Some forms and dosages of ibuprofen can be obtained over-the-counter, while other forms and dosages require a prescription. 25. Mr. Pathak knew or had reason to believe the prescriptions Patient N.C. presented to him at Respondent on or about March 18 and 24, 2011, were fraudulent. DOH v. Prime Synergy, LLC Page 5 of 21 DOH Case Number 2012-07512 26. Mr. Pathak dispensed controlled substances to Patient N.C. too frequently and in a manner that was not in the best interest of the patient. 27. Mr. Pathak engaged in excessive and inappropriate dispensing of controlled substances to Patient N.C. Facts Specific to Patient A.D. 28. On or about March 8, 2011, Patient A.D. presented three prescriptions to Mr. Pathak at Respondent. 29. The prescriptions, written by Dr. V. S., were for 30 diazepam 5 mg, 60 methocarbamol 750 mg, and 120 oxycodone 30 mg. 30. Mr. Pathak dispensed the medications pursuant to each prescription. 31. Methocarbamol is a muscle relaxant and is used to treat pain or injury. Methocarbamol is a legend drug, but not a controlled substance. 32. On or about March 25, 2011, Patient A.D. presented three prescriptions to Mr. Pathak at Respondent. 33. Although the prescriptions were purportedly written by Dr. A.W., they were actually written by Patient N.C. 34. The prescriptions, which were dated March 21, 2011, were for 60 Xanax 2 mg, 180 oxycodone 30 mg, and 30 ibuprofen 800 mg. OOH v. Prime Synergy, LLC Page 6 of 21 DOH Case Number 2012-07512 35. Mr. Pathak dispensed the medications pursuant to each prescription without first attempting to verify the prescriptions. 36. Mr. Pathak knew or had reason to believe the prescriptions Patient A.D. presented to him at Respondent on or about March 25, 2011, were fraudulent. ' 37. Mr. Pathak dispensed controlled substances to Patient A.D. too frequently and in a manner that was not in the best interest of the patient. 38. Mr. Pathak engaged in excessive and inappropriate dispensing of a controlled substance to Patient A.D. Facts Specific to Patient A.R. 39. On or about February 15, 2011, Patient A.R. presented two prescriptions to Mr. Pathak at Respondent. 40. These prescriptions, written by Dr. M.M., were for 180 oxycodone 30 mg and 90 diazepam 10 mg. 41. Mr. Pathak dispensed the medications pursuant to each prescription. 42. On or about March 5, 2011, Patient A.R. presented a prescription, written by Dr. V.S., for 168 oxycodone 30 mg to Mr. Pathak at Respondent. DOH v. Prime Synergy, LLC Page 7 of 21 DOH Case Number 2012-07512 . 43. Mr. Pathak dispensed the medication pursuant to the prescription. 44. On or about March 11, 2011, Patient A.R. presented two prescriptions to Mr. Pathak at Respondent. 45. Although the prescriptions purported to be written by Dr. A.W., - they were actually written by Patient N.C. 46. The prescriptions, dated March 9, 2011, were for 60 Xanax 2 mg and 180 oxycodone 30 mg. 47. Mr. Pathak dispensed the medications pursuant to each prescription without first attempting to verify the prescriptions. 48. On or about March 17, 2011, Patient A.R. presented three prescriptions to Mr. Pathak at Respondent. 49. Although the prescriptions purported to be written by Dr. A.W., they were actually written by Patient N.C. 50. The prescriptions, dated March 16, 2011, were for 60 Xanax 2 mg, 30 Ibuprofen 800 mg, and 180 oxycodone 30 mg. 51. Mr. Pathak dispensed the medications pursuant to each prescription without first attempting to verify the prescriptions. DOH v. Prime Synergy, LLC Page 8 of 21 DOH Case Number 2012-07512 52. Mr. Pathak knew or had reason to believe the prescriptions Patient A.R. presented to him on or about March 11 and 17, 2011, were fraudulent. 53. Mr. Pathak dispensed controlled substances to Patient A.R. too frequently and not in the best interest of the patient. 54. Mr. Pathak engaged in excessive and inappropriate dispensing of controlled substances to Patient A.R. Facts Specific to Patient N.R. 55. On or about January 13, 2012, Patient N.R. presented three prescriptions written by Dr. M.M. to Mr. Pathak at Respondent. 56. The prescriptions were for 50 hydromorphone 8 mg, 130 — hydromorphone 8 mg, and 60 alprazolam 2mg. 57. Mr. Pathak dispensed the medications pursuant to each prescription. 58. Hydromorphone is commonly prescribed to treat pain. According to Section 893.03(2), Florida Statutes (2010-2011), hydromorphone is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted DOH v. Prime Synergy, LLC Page 9 of 21 DOH Case Number 2012-07512 medical use in treatment in the United States. Abuse of hydromorphone may lead to severe psychological or physical dependence. 59. On or about February 10, 2012, Mr. Pathak dispensed medication pursuant to a prescription for 50 hydromorphone 8 mg written ~ by Dr. M.M. for Patient N.R. 60. On or about February 11, 2012, Mr. Pathak dispensed medication pursuant to a prescription for 130 hydromorphone 8 mg written by Dr. M.M. for Patient N.R. 61. On or about March 9, 2012, Mr. Pathak dispensed medication pursuant to two prescriptions for a total of 180 hydromorphone 8 mg written by Dr. M.M. for Patient N.R. | 62. On or about April 5, 2012, Mr. Pathak dispensed medication pursuant to a prescription for 90 hydromorphone 8 mg written by Dr. M.M. for Patient N.R. . - 63. On or about April 6, 2012, Mr. Pathak dispensed medication pursuant to a prescription for 90 hydromorphone 8 mg written by Dr. M.M. for Patient N.R. DOH v. Prime Synergy, LLC Page 10 of 21 DOH Case Number 2012-07512 64. On or about May 3, 2012, Mr. Pathak dispensed medication pursuant to two prescriptions for a total of 180 hydromorphone 8 mg written by Dr. M.M. for Patient N.R. 65. On or about May 31, 2012, Mr. Pathak dispensed medication pursuant to two prescriptions for a total of 170 hydromorphone 8 mg written by Dr. M.M. for Patient N.R. 66. On or about June 27, 2012, Mr. Pathak dispensed medication pursuant to a prescription for 120 hydromorphone 8 mg written by Dr. M.M. for Patient N.R. 67. On or about June 28, 2012, Mr. Pathak dispensed medication pursuant to a prescription for 50 hydromorphone 8 mg written by Dr. M.M. for Patient N.R. 68. On or about July 30, 2012, Mr. Pathak dispensed medication pursuant to two prescriptions for a total of 160 hydromorphone 8 mg written by Dr. M.M. for Patient N.R. 69. On or about August 1, 2012, Mr. Pathak dispensed medication pursuant to a prescription for 10 oxymorphone 10 mg written by Dr. M.M. for Patient N.R. DOH v. Prime Synergy, LLC Page 11 of 21 DOH Case Number 2012-07512 70. Oxymorphone is prescribed to treat pain. According to Section 893.03(2), Florida. Statutes (2010-2011), 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 physical dependence. 71. Between approximately August 24, 2012, and approximately August 27, 2012, Mr. Pathak dispensed medication pursuant to two prescriptions for a total of 120 hydromorphone 8 mg written by Dr. M.M. for Patient N.R. 72. On or about August 31, 2012, Mr. Pathak dispensed medication pursuant to a prescription for 10 oxymorphone 10 mg written by Dr. M.M. for Patient N.R. 73. On or about September 4, 2012, Mr. Pathak dispensed medication pursuant to a prescription for 40 hydromorphone 8 mg written by Dr. M.M. for Patient N.R. 74. Mr. Pathak dispensed controlled substances to Patient N.R. too frequently and not in the best interest of the patient. DOH v. Prime Synergy, LLC Page 12 of 21 DOH Case Number 2012-07512 75. Mr. Pathak engaged in excessive and inappropriate dispensing of controlled substances to Patient N.R. Facts Specific to Patient K.H. 76. On or about January 24, 2012, Mr. Pathak . dispensed medication pursuant to two prescriptions for 300 methadone 10 mg and 300 oxycodone 30 mg, written by Dr. A.A. for Patient K.H. 77. Methadone is prescribed to treat pain. According to Section — 893.03(2), Florida Statutes (2010-2011), methadone 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 methadone may lead to severe psychological or physical dependence. 78. On or about February 21, 2012, March 21, 2012, April 17, 2012, and May 15, 2012, Patient K.H. presented prescriptions written by Dr. A.A. to Mr. Pathak at Respondent. 79. On each date, Mr. Pathak dispensed medication pursuant to prescriptions for 300 oxycodone 30 mg, 90 alprazolam 2 mg, 300 methadone 10 mg, and 120 hydrocodone/APAP 10/500 mg. DOH v. Prime Synergy, LLC Page 13 of 21 DOH Case Number 2012-07512 80. Hydrocodone/APAP contains hydrocodone and acetaminophen, or Tylenol, and is prescribed to treat pain. According to Section 893.03(3), Florida Statutes (2010-2011), hydrocodone, in the dosages found in hydrocodone/APAP, is a Schedule III controlled substance that has a potential for abuse less than the substances in Schedules I and II and has a currently accepted medical use in treatment in the United States. 81. On or about June 12, 2012, Mr. Pathak dispensed medication pursuant to prescriptions for 300 methadone 10 mg, 120 hydrocodone/APAP 10/500 mg, 300 oxycodone 30 mg, and 90 alprazolam 2 mg, written by Dr. M.G. for Patient K.H. 82. On or about July 10, 2012, Mr. Pathak dispensed medication pursuant to prescriptions for 180 oxycodone 30mg, 180 methadone 10mg, and 60 alprazolam 2mg, written by Dr. T.V. for Patient K.H. 83. On or about August 4, 2012, Mr. Pathak dispensed medication pursuant to prescriptions for 240 methadone 10 mg and 120 hydrocodone/APAP 10/500 mg, written by Dr. T.V. for Patient K.H. 84. On or about August 7, 2012, Mr. Pathak dispensed medication pursuant to prescriptions for 180 oxycodone 30 mg and 60 alprazolam 2 mg, written by Dr. T.V. for Patient K.H. DOH v. Prime Synergy, LLC Page 14 of 21 DOH Case Number 2012-07512 85. Mr. Pathak dispensed similar controlled medications to Patient K.H. on the same day, which is not in the best interest of the patient. 86. Mr. Pathak engaged in excessive and inappropriate dispensing of controlled substances to Patient K.H COUNT ONE 87. Petitioner realleges paragraphs 1 through 86, as if fully set forth herein. 88. Section 465.023(1)(h), Florida Statutes (2010-2011), subjects a pharmacy to discipline if it or any affiliated person or agent dispensed any medicinal drug based upon a communication that purports to be a prescription as defined by Section 465.003(14), Florida Statutes, or Section 893.02, Florida Statutes, when the pharmacist knows or has reason to believe that the purported prescription is not based upon a valid practitioner-patient relationship. 89. Section 465.003(14), Florida Statutes (2010-2011), states in pertinent part “Prescription” includes an order for drugs or medicinal supplies written or transmitted by any means of communication by a duly licensed practitioner authorized by the laws of the state to prescribe such drugs or medicinal supplies and intended to be dispensed by a pharmacist. DOH v. Prime Synergy, LLC Page 15 of 21 DOH Case Number 2012-07512 90. Section 893.02(22), Florida Statutes (2010-2011), states in pertinent part “Prescription” means and includes an order for drugs or medicinal supplies written, signed, or transmitted by word of mouth, telephone, telegram, or other means of communication by a duly licensed practitioner licensed by the laws of the state to prescribe such drugs or medicinal supplies, issued in good faith and in the course of professional practice, intended to be filled, compounded, or dispensed by another person licensed by the laws of the state to do so, and meeting the requirements of Section 893.04, Florida Statutes. 91. Based upon the foregoing, Respondent violated Section 465.023(1)(h), Florida Statutes (2010-2011), when Mr. Pathak dispensed medicinal drugs to Patients N.C., A.R., and A.D. based upon prescriptions Mr. Pathak knew or had reason to believe were not based upon a valid practitioner-patient relationship. . COUNT TWO 92. Petitioner realleges paragraphs 1 through 86, as if fully set forth herein. 93. Section 465.023(1)(c), Florida Statutes (2010-2011), subjects a pharmacy to discipline if it or any affiliated person or agent violated Chapter 465, Florida Statutes, or any rules of the Board of Pharmacy. DOH v, Prime Synergy, LLC Page 16 of 21 DOH Case Number 2012-07512 94. Rule 64B16-27.831, Florida Administrative Code, which sets forth the standards for the practice of dispensing controlled substances for the treatment of pain, states in pertinent part (1) An order purporting to be a prescription that is not issued for a legitimate medical purpose is not a prescription and the pharmacist knowingly filling such purported prescription shall be subject to penalties for violations of the law. (2) The following criteria shall cause a pharmacist to question whether a prescription was issued for a legitimate medical purpose: a. Frequent loss of controlled substance medications, b. Only controlled substance medications are prescribed for a patient, c. One person presents controlled substance prescriptions with different patient names, d. Same or similar controlled substance medication is prescribed by two or more prescribers at same time, e. Patient always pays cash and always insists on brand name product. (3) If any of the criteria in (2) is met, the pharmacist shall: a. Require that the person to whom the medication is dispensed provide picture identification... [....] b. Verify the prescription with the prescriber. [....] KK 95. Respondent violated Section 465.023(1)(c), Florida Statutes (2010-2011), when Mr. Pathak violated Rule 64B16-27.831 in the following ways: DOH v. Prime Synergy, LLC . Page 17 of 21 DOH Case Number 2012-07512 a. by knowingly filling purported prescriptions for Patients N.C., A.R., and A.D. that were not issued for a legitimate medical purpose; and b. by failing to verify the purported prescriptions presented by Patients N.C., A.R., and A.D. with the purported prescriber. 96. Based upon the foregoing, Respondent violated Section 465.023(1)(c), Florida Statutes (2010-2011), when Mr. Pathak violated Rule 64B16-27.831, Florida Administrative Code. COUNT THREE 97. Petitioner realleges paragraphs 1 through 86, as if fully set forth herein. 98. Section 465.023(1)(c), Florida Statutes (2010-2011), subjects a pharmacy to discipline if it or any affiliated person or agent violated Chapter 465, Florida Statutes, or any rules of the Board of Pharmacy. 99. Section 465.016(1)(i), Florida Statutes (2010-2011), subjects a pharmacist to discipline for dispensing a legend drug, including any controlled substance, other than in the course of the professional practice of pharmacy. For purposes of Section 465.016(1)(i), Florida Statutes (2010-2011), it is legally presumed that the dispensing of legend drugs in DOH v. Prime Synergy, LUC Page 18 of 21 DOH Case Number 2012-07512 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. 100. Respondent violated Section 465.023(1)(c), Florida Statutes (2010-2011), when Mr, Pathak violated Section 465.016(1)(i), Florida Statutes (2010-2011), in the following ways: a. by dispensing controlled substances based upon fraudulent prescriptions presented by Patients N.C., A.R., and A.D.; and b. by dispensing excessive or inappropriate quantities of controlled substances to Patients N.C., A.D., A.R., N.R., and K.H. 101. Based upon the foregoing, Respondent violated Section 465.023(1)(c), Florida Statutes (2010-2011), when Mr. Pathak violated Section 465.016(1)(i), Florida Statutes (2010-2011). WHEREFORE, Petitioner respectfully request that the Board of Pharmacy enter an order imposing one or more of the following penalties: revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of Respondent on probation, corrective action, remedial education, payment of costs, and/or any other relief that the Board deems appropriate. DOH v. Prime Synergy, LLC Page 19 of 21 DOH Case Number 2012-07512 ce, SIGNED this__ |i day of October 2012. FILED DEPARTMENT OF HEALTH DEPUTY CLERK cLERK Angel Sanders pare OCT 15 20re PCP Date: JOHN H. ARMSTRONG, MD State n General and Secretary of Health C 5 te “oo N Alicia E. Adams, Esq. Assistant General Counsel Florida Bar Number 0065248 Department of Health, Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (P) 850-245-4546 (F) 850-245-4662 (E) Alicia_Adams@doh.state.fl.us October 15, 2012 PCP Members: Leo Fallon, BPharm, PhD and Michele Weizer, PharmD DOH v. Prime Synergy, LLC DOH Case Number 2012-07512 Page 20 of 21 NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Sections 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 Respondent in addition to any other discipline imposed. DOH v. Prime Synergy, LLC Page 21 of 21 DOH Case Number 2012-07512

Docket for Case No: 15-006895