STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, Vv. CASE NO.: 2011-09924 CORAL WEST PHARMACY, INC,, d/b/a WESTCHESTER PHARMACY, RESPONDENT. / DMIN IVE P Petitioner Department of Health (“Department”) files _ this Administrative Complaint before the Board of Pharmacy against Coral West Pharmacy, Inc., d/b/a Westchester Pharmacy (“Coral West” or the “Pharmacy”), and in support thereof alleges: 1. The Department Is the state agency charged with regulating pharmacies in Florida, pursuant to Chapters 20, 456 and 465, Florida Statutes (2010). . 2. At all times material to this Order, Coral West was licensed to _ Operate as a pharmacy in the State of Florida pursuant to Chapter 465, Florida Statutes. Filed August 9, 2011 4:34 PM Division of Administrative Hearings DOH v, Coral West Pharmacy, Inc., d/b/a Westchester Pharmacy Case No. 2011-09924 3. On January 13, 2011, an undercover Investigator (‘UC”) from the Florida Attorney General’s Medicaid Fraud Control Unit (“MFCU”) and a confidential informant (“CI’)' presented to Coral West as Medicaid recipients seeking to sell prescriptions? to Coral West. 4. Once within the Pharmacy, UC and CA met with the Pharmacy’s registered technician (the “R.T.”), who asked CI to identify which prescriptions he wanted filled and which ones he wanted to sell. CI advised the R.T. that he wanted to sell his prescriptions for Prevacid and Crestor and that he wanted his remaining prescriptions? filled. 5. Prevacid belongs to a class of antisecretory compounds and is used to suppress gastric acid secretion. Crestor is a synthetic lipid- lowering agent. 1 Before becoming @ confidential Informant for MFCU, CI routinely sold prescriptions to Coral West, 2 CI had previously provided Cora! West with paper prescriptions for these medications and, during this visit, sought a refill of the medications. Cl’s remaining prescriptions were for Temazepam, Lisinopril, Alprazolam, Metropoto!, Digoxin and Furosemide. Temazepam contains benzodiazepine and Is prescribed for the short-term treatment of sleeplessness In patients who have difficulty maintaining sleep, According to Section 893,03(4), Florida Statutes, Temazepam Is a Schedule 1V 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 Temazepam may tead to limited physical or psycholagical dependence relative to the substances In Schedule IIT, Lsinoprit Is an anglotensin-converting enzyme (ACE) inhibitor that Is primarily used in weatment of hypertension, congestive heart fallure, and heart attacks and also In preventing rena! and retinal complications of diabetes. Alprazolam (brand name Xanax, benzodiazepine) is prescribed to treat anxiety. According to Section 893,03(4), Florida Statutes, alprazolam Is-@ Schedule 1V controfled substance that has a low potential for abuse relative to the substances in Schedule IIT and has a currently accepted medical use in treatment In the United States. Abuse of alprazolam may tead to Smited physical or psychological dependence relative to the substances In Schedule TI], Metropoto! is a selective Bi; receptor blocker used in treatment of several diseases of the cardiovascular system, especially hypertension. Digoxin is indicated for the treatment of various heart conditions, namely atrial fibrillation, atrial flutter and sometimes heart fallure that cannot be controlled by other medication, Furosemide Is a loop diuretic used in the treatment of congestive heart fallure and edema. DOH v. Coral West Pharmacy, Inc,, d/b/a Westchester Pharmacy Case No, 2011-09924 6. At the conclusion of this visit, Coral West provided CI with an envelope containing $30.00 for the Prevacid prescription and $30.00 for the Crestor prescription. Following this visit, Coral West billed, and received payment from, the Medicaid Program for the Crestor and Prevacid prescriptions presented by CI that were never filled or dispensed by the © Pharmacy. In addition, Coral West billed, and received payment from, the Medicaid Program for a Plavix prescription that CI did not present to Coral _ West and that was never filled or dispensed by the Pharmacy. In total, Coral West collected payment from the Medicaid Program in the amount of $453.91 for purportedly filling the Plavix, Crestor and Prevacid prescriptions presented by CI. 7. Plavix is the brand name for clopidogrel, an antiplatelet agent used to inhibit blood clots. 8. On or about January 20, 2011, CI dropped off prescriptions for Lidoderm and Abilify at Coral West for the purpose of selling the prescriptions to the Pharmacy. According to a prior arrangement between CI and the R.T., CI was to be paid $50.00 for each Abilify prescription and $30.00 for each Lidoderm prescription sold to Coral West. DOH v. Coral West Pharmacy, Inc., d/b/a Westchester Pharmacy Case No. 2011-09924 9, Abilify is an atypical antipsychotic and antidepressant used in the treatment of schizophrenia, bipolar disorder and clinical depression. 10. Lidoderm is an adhesive patch that contains lidocaine, a local anesthetic that may lead to severe toxicity or death in both children and adults if used Improperly. 11. On January 27, 2011, CI and UC presented to Coral West to collect payment on the Abilify and Lidoderm prescriptions CI had previously delivered to the Pharmacy. At the conclusion of this visit, Coral West made payment to CI in the amount of $50.00 for the Abilify prescription and $30.00 for the Lidoderm prescription. After this visit, Coral West collected payment from the Medicaid Program in the amount of $688.01 for the Abilify and Lidoderm prescriptions presented by CI, neither of which was ever actually filled. 12. On or about February 15, 2011, CI and UC presented to Coral West in order to sell Cl’s prescriptions for Prevacid, Plavix and Abilify to the Pharmacy. CI presented hardcopy prescriptions for Prevacid and Plavix and refill prescriptions for several other medications’, Including Abilify and ‘The other refill prescriptions presented by CI were for medications that Included Alprazolam, Furosemide, Metropolol, Lisinopril, Olgoxin, Nitrostat, Carvedilol and Temazepam, Nitrostat contains nitraglycerin, which is used medically as a vasodilator to treat heart conditions, such as angina and chronic heart fallure. Carvedito! Is a non-selective beta blocker/alpha-1 blocker indicated in the treatment of nilld to moderate congestive heart fallure, DOH v, Coral West Pharmacy, Inc., d/b/a Westchester Pharmacy Case No, 2011-09924 Crestor, to the Pharmacy. During this visit, the R.T. advised CI and UC that Coral West would make payment to CI for the prescriptions presented that day on a later date. 13. On February 22, 2011, CI and UC returned to Coral West. The R.T. made payment to CI for the Abilify, Prevacid, Plavix and Crestor | prescriptions presented by CI on February 17, 2011, In the amount of $60.00 for the Abilify prescription, $30.00 for the Prevacid prescription, $30.00 for the Plavix prescription and $30.00 for the Crestor prescription, _ for a total of $150.00. -Coral West subsequently billed, and recelved payment from, Medicald in the amount of $960.64 for the four prescriptions, none of which was filled by the Pharmacy. 14. On March 15, 2011, CI presented to Coral West with refill prescriptions for Carvedilol, Spironolactone, Temazepam, Metropoiol, Lisinopril, Furosemide, Digoxin, Alprazolam, Aspirin, Crestor, Prevactd, Abilify and Plavix. Spironolactone Is a diuretic used primarily to treat heart failure 15. As with prior visits, CI identified those prescriptions he wanted filled and those he wanted to sell. At the conclusion of this visit, CI received payment from Coral West In the amount of $140.00 for his DOH v. Coral West Pharmacy, Inc., d/o/a Westchester Pharmacy Case No, 2011-09924 Crestor, Prevacid, Abilify and Plavix prescriptions. Subsequently, Coral West billed, and received payment from, Medicaid in the amount of $1,012.27 for the Crestor, Prevacid, Abilify and Plavix prescriptions, none of which was filled by the Pharmacy. - 16. On April 14, 2011, CI and UC again presented at Coral West. CI and UC had previously dropped off prescriptions for Lidoderm, Crestor, Plavix, Abilify, Prevacid, Digoxin, Lisinopril, Aspirin, Metropolol, Furosemide, Carvedilol and Spironolactone at Coral West and were returning to pick up the medications that were to be filled and to collect payment on those that were being: sold to the Pharmacy. During this visit, CI identified those prescriptions he wanted to sell to the Pharmacy and those he wanted to be filled, At the conclusion. of this visit, Coral -West made payment to CI in the amount of $140.00 for his prescriptions for Crestor, Prevacid, Abilify and Plavix, none of which was filled by Coral West. Coral West subsequently billed, and received payment from, Medicaid in the amount of $1,196.10 for the Lidgderm®, Crestor, Prevacid, Abilify and Plavix prescriptions, none of which was filled by the pharmacy. CI’s remaining prescriptions were filled by the Pharmacy. During the course of this visit, CI also sold seven 5 Coral west neither filled, nor paid CI for, the Lidoderm prescription. DOH v, Coral West Pharmacy, Inc., d/b/a Westchester Pharmacy Case No. 2011-09924 boxes of Lidoderm patches he obtained from a third party® to the Pharmacy for $190.00. 17, On May 12, 2011, CI and UC returned to Coral West to pick up medications and collect payment in connection with prescriptions CI had previously dropped off at the Pharmacy. A short time later, Coral West's pharmacist dispensed the following medications to CI: Alprazolam, Furosemide, Temazepam, Digoxin, Lisinopril, Amlodipine Besylate, Splronolactone, Carvedilol and Aspirin. Amlodipine Besylate is a long- acting calclum channel blocker ‘(dihydropyridine class) used as an anti- hypertensive and In the treatment of angina. 18. Later this visit, Coral West made payment to CI in the amount of $140.00 for his prescriptions for Crestor, Prevacid, Abilify and Plavix, none of which was filled by Coral West. Coral West subsequently billed, . and received payment from, Medicaid in the amount of $1,196.10 for the Lidoderm’, Crestor, Prevacid, Abilify and Plavix prescriptions, none of which . was filled by the Pharmacy. § This person was a customer of the Pharmacy and was not authorized to distribute prescription drugs. 1 coral West neither filled, nor paid CI for, the Lidoderm prescription. DOH vy, Coral West Pharmacy, Inc., d/b/a Westchester Pharmacy Case No, 2011-09924 19. On June 9, 2011, Department investigators performed an inspection of Coral West. During the course. of their inspection, the Department's investigators determined that Coral West was not safe to operate as a pharmacy because (1) there were no pedigree documents identifying the source of many of the medications being held in the Pharmacy’s Inventory; (2) medications bearing labels from other pharmacies were being held In Coral West’s Inventory; and (3) multiple bottles of medications without labels were being held In the Pharmacy’s inventory. ~ COUNT I 20. The Department realleages and incorporates paragraphs 1 through 19 above as if fully set forth herein. 21, Section 465.016(1)(1), Florida Statutes (2010), subjects a pharmacy to discipline for placing in its stock any part of any prescription compounded or dispensed which has been returned by a patient. 22. Coral West violated Section 465.016(1)(I), Florida Statutes (2010), by placing In its stock parts of prescriptions compounded or dispensed which were returned by patients. COUNT Il DOH v. Coral West Pharmacy, Inc., d/b/a Westchester Pharmacy Case No, 2011-09924 23. The Department realleages and incorporates paragraphs 1 | through 19 above as if fully set forth herein. 24. Section 465.016(1)(r), Florida Statutes (2010), subjects a _ pharmacy to discipline for violating any provision of Chapters 465 or 456, Florida Statutes (2010), or any rules adopted pursuant thereto, Section 456.072(1)(m), Florida Statutes (2010), subjects licensees, including pharmacies, to discipline for making deceptive, untrue, or fraudulent representations in or related to the practice of a profession or employing a trick or scheme in or related to the practice of a profession. 25. Coral West violated Section 456.072(1)(m), Florida Statutes (2010), by billing the Medicaid Program for filling prescriptions it did not actually fill. By violating Section 456.072(1)(m), Florida Statutes (2010), Coral West also violated Section 465.016(1)(r), Florida Statutes (2010). OUNT Ti 26. The Department realleages and Incorporates paragraphs 1 through 19 above as if fully set forth herein. 27. Section 465.023(1)(c), Florida Statutes (2010), subjects a pharmacy to discipline for violating any of the requirements of Chapter 499, Florida Statutes. Section 499.005, Florida Statutes (2010), prohibits, DOH v, Coral West Pharmacy, Inc., d/b/a Westchester Pharmacy Case No, 2011-09924 in relevant part, the holding or offering for sale of any drug that is adulterated, the receipt of any drug that is adulterated and the failure to acquire a pedigree paper in connection with the purchase of a prescription drug. According to Section 499.006, Florida Statutes (2010), a drug is adulterated if it is a prescription drug for which the required. pedigree paper is nonexistent, fraudulent, or incomplete under the requirements of this part or applicable rules, or that has been purchased, held, sold, or distributed at any time by a person not authorized under federal or state law to do so, . 28. Coral West violated Section 499.005, Florida Statutes (2010), by purchasing and holding prescription drugs that were adulterated and by failing to have pedigree papers for prescription drugs in its inventory. By violating Section 499.005, Florida Statutes (2010), Coral West also violated Section 465.023(1)(c), Florida Statutes (2010). WHEREFORE, the Department respectfully requests the Board of Pharmacy enter an order imposing one or more of the following penalties against Coral West's license to operate as a pharmacy: permanent revocation or suspension, restriction of practice, administrative fine, DOH v. Coral West Pharmacy, Inc., d/b/a Westchester Pharmacy Case No. 2011-09924 reprimand, probation, corrective action, refund of fees billed or collected, remedial education and any other relief the Board deems appropriate. we SIGNED this_ 2/0 dayof__ | JULY , 2011. H. Frank Farmer, Jr., M.D., Ph.D. . State Surgeon General fr anlel Hernandez, Chief Legal Counsel! FILED Florida Bar No. 176834 PHN O04ZISS DEPARTMENT OF HEALTH DOH Prosecution Services Unit 4052:Bald Cypress Way, Bin C-65 CLERKNT ILA, Tinie, Tallahassee, FL 32399-3265 pare XX -20( soy 245-4640 (850) 245-4681 FAX PCP: alocefoo" | PCP Members: (LAZEr , Risch DOH v, Coral West Pharmacy, Inc., d/b/a Westchester Pharmacy Case No. 2011-09924 T. F HT. ' 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. - E ARDI E 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. 12

Docket for Case No: 11-003994