Aug 15 2005 3:14 AUIG-15-2885 Get26 AHCA P.@3 STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, Petitioner, VS. CASE NO. 2003-14898 ESTELA PINNAVARIA, R.PH., Respondent. | ADMINISTRATIVE COMPLAINT Petitioner, DEPARTMENT OF HEALTH, by and_ through undersigned counsel, files this Administrative Complaint before the Board of Pharmacy against Respondent, ESTELA PINNAVARIA, R.PH.., 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; Chapter 456, Florida Statutes; and Chapter 465, Florida Statutes. 2. At all times material to this complaint, Respondent was a licensed pharmacist within the State of Florida, having been issued license number PS 31335. 3. Respondent's address of record is 9161 East Bay Harbor Drive, Suite #7-A, Bay Harbor Island, Florida 33154. 1 Aug 15 2005 3:15 AUG-15-2885 ete? AHCA 4. Section 465.018, Florida Statutes (2002), states that any person desiring a permit to operate a community pharmacy shall apply to the department. No permit shall be issued unless a licensed pharmacist is designated as the prescription department manager responsible for maintaining all drug records, providing for the security of the prescription department, and following such other rules as relate to the practice of the profession of pharmacy. 5. On or about May 1, 2003, an ‘investigator for the Department of Health (DOH) conducted a routine inspection’ of Pharmasource DME, Inc. (Pharmasource), a Community and Special Parenteral/Enteral pharmacy, located at 15173 B NE 21* Avenue, North Miami Beach, Florida 33162. 6. At all times material to this Administrative Complaint, Respondent was the Prescription Department Manager of Pharmasource. 7. During the inspection of Pharmasource on May 1, 2003, the following deficiencies were noted: a. There was no current copy of reference manuals or Florida Pharmacy laws and rules; Aug 15 2005 3:15 AUIG-15-2885 ete? AHCA b. There was no. proof of Continuous Quality Improvement (CQT) Policies and Procedures or proof of the required CQI meetings; c. No. biennial inventory of controlled substances available for inspection; and d. Outdated pharmaceuticals were found in the active stock of the prescription department. 8. On or about June 6, 2003, a DOH investigator conducted a re-inspection of Pharmasource. 9. During the re-inspection of Pharmasource on June 6, 2003, the following deficiencies were noted: a. There was no current copy of the Florida Pharmacy faws and rules; and b. There was no proof of CQI Policies and Procedures or proof of the required CQI meetings. 10. Section 465.016(1)(r), Florida Statutes (2002), provides that violating any provision of Chapter 465 or Chapter 456, or any rules adopted pursuant thereto, constitutes grounds for disciplinary action. Aug 15 2005 3:15 AUIG-15-2885 ete? AHCA 11. Section 456.072(1)(k), Florida Statutes (2002), provides that failing to perform any statutory or legal obligation placed upon a licensee constitutes grounds for which disciplinary action may be taken. COUNT ONE 12. Petitioner realleges and incorporates paragraphs one (1) through eleven (11) as if fully set herein. 13. Rule 64B16-28.107(1), Florida Administrative Code, requires that a prescription department be minimally equipped with a current pharmacy reference compendium such as the United States Pharmacopoeial/National Formulary, the U.S. Dispensatory, USPDI (United States Pharmacopoeial Drug Information), the Remington Practice of Pharmacy, Facts and Comparisons or an equivalent thereof sufficient in scope to meet the professional practice needs of that pharmacy, and a current copy of the laws and rules governing the practice of pharmacy in the State of Florida. It shall be acceptable, in lieu of an actual hard copy, to maintain these materials in a readily available electronic data format. Aug 15 2005 3:15 AUIG-15-2885 ete? AHCA 14. On May i, 2003 and June 6, 2003, Respondent could not furnish to the DOH investigator a current copy of the pharmacy laws and rules or a current reference compendium. 15. Respondent, in her capacity as prescription department manager, failed to ensure that Pharmasource was in compliance with the rules related to the practice of pharmacy by failing to provide to the DOH investigator a current copy of the pharmacy laws and rules or a current reference compendium. 16. Based upon the foregoing, Respondent is subject to . discipline for violating Section 465.016(1)(r), Florida Statutes (2002), by violating a provision of Chapter 456, or any rules adopted pursuant thereto, through a violation of Section 456.072(1)(k), Florida Statutes (2002), by failing to perform any statutory or legal obligation imposed upon a licensee, created by her status as prescription department manager pursuant to Section 465.018, Florida Statutes (2002), by failing to ensure that the pharmacy at which she is prescription department manager complied with the rules of the Board of Pharmacy, specifically Rule 64B16-28.107(1), Florida Administrative Code, by failing to provide to the DOH Aug 15 2005 3:16 AUG-15-2885 8:28 AHCA investigator a current copy of the Pharmacy laws and rules or a current reference compendium. COUNT TWO 17. Petitioner realleges and incorporates paragraphs one (1) through eleven (11) as if fully set herein. 18, Rule 64B16-27.300(3)(a)2, Florida Administrative Code, requires that each pharmacy establish a CQI Program that shall be described in the pharmacy’s policy and procedure manual and, at a . minimum, shall contain provisions for the prescription department manager of record to ensure that the committee conducts a review of Quality Related Events at least every three months. 19. On May 1, 2003 and June 6, 2003, Respondent did not furnish to the DOH investigator a CQI Policy and Procedures manual or proof of any required CQI quarterly meetings taking place. 20. Respondent, in her capacity as prescription department manager, failed to ensure that Pharmasource was in compliance with the rules related to the practice of pharmacy by failing to provide to the DOH investigator a COI Policy and Procedures manual or proof of any required CQI quarteriy meetings taking place. Aug 15 2005 3:16 AUG-15-2885 8:28 AHCA 21. Based upon the foregoing, Respondent is subject to discipline for violating Section 465.016(1)(r), Florida Statutes (2002), by violating a provision of Chapter 456, or any rules adopted pursuant thereto, through a violation of Section 456.072(1)(k), Florida Statutes (2002), by failing to perform any statutory or legal obligation imposed upon a licensee, created by her status as prescription department manager pursuant to Section 465.018, Florida Statutes (2002), by failing to ensure that the pharmacy at which she is prescription department manager complied with the rules of the Board of Pharmacy, specifically Rule 64B16- 27.300(3)(a)2, Florida Administrative Code, by not having a CQI Policies and Procedures manual or proof of the required CQI quarterly meetings taking place. COUNT THREE 22. Petitioner realleges and incorporates paragraphs one (1) through seven (7), ten (10) and eleven (11) as if fully set herein. 23. Section 893.07(4)(b), Florida Statutes (2002), requires that records of controlled substances be kept and made available for inspection for a period of at least 2 years. Aug 15 2005 3:16 AUG-15-2885 8:28 AHCA 24. On May 1, 2003, Respondent was unable to provide Pharmasource’s biennial controlled substance inventory to the DOH investigator for review. 25. Respondent, in her capacity as prescription department manager, failed to ensure that Pharmasource was in compliance with the statutory requirements related to the practice of pharmacy by failing to provide to the DOH investigator Pharmasources’s biennial controlled substance inventory. 26. Based upon the foregoing, Respondent is subject to discipline for violating Section 465.016(1)(r), Florida Statutes (2002), by violating a provision of Chapter 456, or any rules adopted pursuant thereto, through a violation of Section 456.072(1)(k), Florida Statutes (2002), by failing to perform any statutory or legal obligation imposed upon a licensee, created by her status as prescription department manager pursuant to Section 465.018, Florida Statutes (2002), by failing to ensure that the pharmacy at which she is prescription department manager complied with Section 893.07(4)(b), Florida Statutes (2002), by failing to provide to the DOH investigator Pharmasource’s biennial controlled substance inventory. Aug 15 2005 3:16 AUIG-15-2885 Get29 AHCA COUNT FOUR 27. Petitioner realleges and incorporates paragraphs one (1) through seven (7), ten (10) and eleven (11) as if fully set herein. 28. Rule 64B16-28.110, Florida Administrative Code, requires that persons qualified to do so examine the stock of the prescription department of each pharmacy at a minimum interval of four months, and remove all deteriorated pharmaceuticals, or pharmaceuticals which bear upon the container an expiration date that has been reached. 29. On May 1, 2003, the DOH investigator found outdated pharmaceuticals in the active stock of the prescription department of Pharmasource. 30. Respondent, in her capacity as prescription department manager, failed to ensure that Pharmasource was in compliance with the rules related to the practice of pharmacy by failing to have outdated pharmaceuticals removed from the active stock of the prescription department. 31. Based upon the foregoing, Respondent is subject to discipline for violating Section 465.016(1)(r), Florida Statutes (2002), by violating a provision of Chapter 456, or any rules adopted pursuant thereto, through a violation of Section 456.072(1)(k), 9 Aug 15 2005 3:17 AUIG-15-2885 Get29 AHCA Florida Statutes (2002), by failing to perform any statutory or legal obligation imposed upon a licensee, created by her status as prescription: department manager pursuant to Section 465.018, Florida Statutes (2002), by failing to ensure that the pharmacy at which she is prescription department manager complied with the rules of the Board of Pharmacy, specifically Rule 64B16-28.110, Florida Administrative Code, by failing to have outdated pharmaceuticals removed from the active stock of the prescription department. 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 license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. Aug 15 2005 3:17 AUIG-15-2885 Get29 AHCA P.13 SIGNED this 34 day of Poguast 2004. John ©, Agwunobi, M.D., M.B.A., M.P.H. Secretary, Department of Health Dewll &. Guia Danille R. Carroll Assistant General Counsel FILED Department of Health aw OF HEALTH Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 CLERK fives Stingtake Tallahassee, Florida 32399-3265 oare__S/.] 04S Florida Bar No. 0101893 (850) 414-8126 (850) 488-1855 Fax PCP: PCP Members: Arlene entra? Estela Pinnavaria, R.Ph, Case 2003-14898 eps“ feop approved by: DWE. (initials) €/3/ 0 (date) 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. Aug 15 2005 3:17 AUIG-15-2885 Get29 AHCA 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. Estela Pinnavatia, R.Ph, Case 2003-14898

Docket for Case No: 05-002893PL