Aug 11 2006 3:03 fug 11 2006 8:00 P.03 ' STATE OF FLORIDA DEPARTMENT OF HEALTH _ DEPARTMENT OF HEALTH, | PETITIONER, uo CASE NO, 2003-06829 STANLEY DYEN, 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, Stanley Dyen, R.Ph,, and in support thereof alleges: | 1. 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. 2. . At all times material to this Complaint, Respondent was a licensed pharmacist within the state of Florida, having been issued license number PS 13959. 3. Respondent's address of record is 5631 Vintage Oaks Circle, Delray Beach, Florida 33484-5219. Aug 11 2006 3:03 fug 11 2006 8:01 P. O04 4, For the time period relevant to this complaint, specifically, February 2003 through June 2003, Respondent was the prescription department manager for Your Druggist, located at 8091 West. Sample Road, in Coral Springs, Florida. °5. Your Druggist is permitted as a community pharmacy by the Florida Board of Pharmacy and holds permit number PH 8106. 6. On or about February 17, 2003, Department of Health (DOH) investigators conducted a routine inspection of Your Druggist. 7. On-or about June 9, 2003, DOH investigators conducted a re- inspection of Your Druggist. 8. Section 465.018, Florida’ Statutes (2002), provides that 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 pharmacy. 9, Section 465. 016(1)(n), Florida Statutes (2002), provides that violating a rule of the Board of Pharmacy or department or violating an order of the Board of Pharmacy or the department. previously entered in a disciplinary proceeding: constitutes grounds for disciplinary action by the Board of Pharmacy. Aug 11 2006 3:03 fug 11 2006 8:01 P.O5 COUNT ONE 10. Petitioner realleges and incorporates paragraphs one (1) through nine.(9) as if fully set forth herein. ' 41. Rule 64B16-28.110, Florida Administrative Code, provides that persons qualified to do so shall examine the stock of the prescription department at a minimum interval of four months and remove alli deteriorated pharmaceuticals or pharmaceuticals that bear upon the container an expiration date which date has been reached. . 12. During the February 17, 2003, inspection, the DOH investigators found outdated medications in the Your Druggist prescription department. 13.. The outdated medications found during the February 17, 2003,. inspection, included: a, Prozac liquid, lot number 4NF57M, expiration 1/03; b,. Hydroxyzine HCl, lot number 23651C, expiration 12/02; c. ‘Quad Tann Ped, Suspension, lot number 70920, expiration 9/02; d. Donnagel Liquid, lot number 0000028, expiration 5/02; e, Dura Dal HD Plus Liquid, lot number 00912, expiration 9/02; Aug 11 2006 3:03 fug 11 2006 8:01 P. O06 f, Cimetidine 200mg tablets, jot number 2660-702, expiration 10/01; 'g. - Calcionate Syrup, lot number 067921, expiration 6/02; he Chiorpheniramine 4mg_ tablets, lot number P20551: expiration 5/02; i. Generlac Solution 10g/i5ml, lot number 23801A, expiration 11/02; , or Furosemide Oral Solution 10mg/ml, lot number 23342C, expiration 7/02; . k. Coumadin 7-1/2 mg tablets, lot number ENE240A, expiration 4/02; I Metoclopramide Oral Solution .5mg/ml, lot number 23594A, expiration 11/02; m. Naproxen Sodium tablets 550mg, lot number 567244, expiration 5/02; n. Vineristine Sulfate Injection, lot mumber 1037139, expiration :8/02: o. Sterile Bacitracin 50,000 units, lot number 37DMW, expiration 4/02; hue 31 2008 rot PLO? p. Darvocet-N' 100 tablets, lot number 3AK83M, expiration 10/02; - | q. Novolin R Pen Fill Insulin, lot number 1M27004, expiration 12/02; r Humulin N. Pen U-100 Insulin, lot number FFON9OA, expiration 6/02; s. Humulin 70/30 Pen U-100 Insulin, lot number FFOL23A, expiration 5/02;.. | t. Chiorhexidiné Digluconate 20%, jot number 59199, expiration 11/99; u. Bubble Gum Flavor Concentrate, lot number 89626, expiration 2/03; V. Promethazine HCI, lot number 50314, expiration 3/01; w. Butylated Hydroxytoluene FCC, jot number 44057, expiration 9/99: x. Betahistine’ Dihydrochlorite, lot number 81515, expiration 12/01; , y. Vitamin D-2, lot number 86938, expiration 7/02; z. Alupent Aerosol, lot number 000253W, expiration 5/02; Aug 11 2006 3:04 fug 11 2006 8:01 P. 08 aa. Promethazine DM Syrup, lot number 0990460, expiration 10/02; bb, Raspberry Fiavor Concentrate, lot number 82386, ‘expiration 4/02; , cc. Orange Flavor Concentrate, lot number 83744, expiration 5/02; dd. Strawberry Flavor Concentrate, lot number .70821, expiration 12/00; ee, Benzocaine Powder, lot number 40879, expiration 5/99; ff. Phenylephrine HC! Powder, lot number 56573, expiration 3/99; gg. Bellaconna Tincture, lot number 12124, expiration 4/01/91; hh. Peppermint Oil, lot number 147684, expiration 6/01; and i. | Betamethasone Dipropionate Powder, lot number BDMO79, expiration 10/00. 14. During the June 9, 2003, inspection, the DOH investigators found outdated medications in the prescription department. Aug 11 2006 3:04 fug 11 2006 8:02 P.09 15, The outdated medications found during the June 9, 2003, - inspection included: a. Pilaudid Cough Syrup, lot number 33300018, expiration 1/2002; , b. Cimetidine HCL Oral Solution, lot number RK1688, expiration 4/03; , ¢. Sodium Polystyrene Sulfonate Powder, lot nurnber’ RB 1243, expiration 11/30/02: d. . Buspirone 5mg tablets, lot number 3015092, expiration 11/2002; a. Per-lax capsules, lot number 0286AB, expiration 11/02; f. Buspirone 10mg tablets, lot number 3013004, expiration 10/2002; g. Epoetin Alfa-Procrit, lot number D002713, expiration 4/03; h. Humulin R inj, lot number FFOM73A, expiration 5/02; i. Neosporin G.U. Irrigant, lot number OA1296, expiration j. Miconazole Nitrate, lot number 63289, expiration 5/03; k. Bethanechol Chloride, lot number 78183, expiration 9/01; Aug 11 2006 38:04 Aug 11 2006 8:02 P10 |. Reserpine Powder, lot numbers 58618 and 67567, expiration 11/02; om, Nystatin USP, lot number 81213, expiration 3/03; and n. Acetylcysteine Inj., lot number 1072-15, expiration 5/03. 16. Based on his status as prescription department manager for Your Druggist, Respondent is responsible for ensuring that Your Druggist complies with all of the rules governing the practice of pharmacy, including ensuring that outdated medications are removed from the active stock of , the prescription department, 17, Based on the foregoing, Respondent has violated Section 465,016(1)(n), Florida Statutes (2002), violating a rule of the board, through @ violation of Rule 64B16-28.110, Florida Administrative Code, by failing to remove outdated pharmaceuticals from the active stock of the prescription. department of the pharmacy at which Respondent serves as ‘the prescription department manager. COUNT TWO 48, Petitioner realleges and incorporates paragraphs one. (1) through nine (9) as if fully set forth in this count. 19. Rule 64B16-27.300(3)(a), Florida Administrative Code, provides that each pharmacy establish a Continuous Quality Improvement Program Aug 11 2006 3:04 fug 11 2006 8:02 P.11 (CQT) with the CQI being described. in the pharmacy’s policy and procedures manual. Ata minimum, the CQI shall contain: provisions for a CQ! committee; provisions for the prescription department manager to ensure that the committee conducts a review of Quality Related events at least every three months; a planned process to record, measure, assess, and improve the quality of patient care; and the procedure for reviewing Quality Related events. 20. Rule 64B16-27.300(5), Florida Administrative Code, provides that the records maintained as @ component of the pharmacy CQI are confidential; however, to determine compliance, the Department may review the policy and procedures and a Summarization of Quality Related Events, 21. During the February 17, 2003, inspection and the June 9, 2003, inspection, the DOH investigator requested to review Respondent's policy | and procedures and summarization of Quality Related Events. , 22, No CQI or Summarization of Quality Related Events was presented to the DOH investigator during the February 17, 2003, inspection. 23. No CQL or Summarization of Quality Reiated Events was presented to the DOH investigator during the June 9, 2003, inspection. 9 Aug 11 2006 3:05 fug 11 2006 8:02 P.12 24. Based on his status -as prescription department manager for Your Drugaist, Respondent is responsible for ensuring that Your Druggist complies with all of the rules governing the practice of pharmacy, including ‘establishing COI and ensuring that Your Druggist’s policy and procedures and Summarization of Quality Related Events are available for review by the Department. 25. Based on the foregoing, Respondent has violated Section , , 465.016(41)(n), Florida Statutes (2002), violating a rule of the board, through a violation of Rule 64B16-27.300(5), Florida Administrative Code, by failing to make the: pharmacy’s policy and procedures, including CQI and a Summarization. of Quality Related Events, available ‘to the Department investigator for-review. 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 ar collected, remedial education and/or any other relief that the Board deems appropriate. Aug 11 2006 3:05 fug 11 2006 8:09 P.13 NS x ‘SIGNED this _3& day of__F, by , 2004. John O. Agwunobi, M.D., M.B.A,, M.P.H, Secretary, Department of Health Deborah B. Loucks ; Assistant General Counsel DEPARTMENT OF HEALTH DOH Prosecution Services Unit DEPUTY CLERK 4052 Bald Cypress Way, Bin C-65 ourex Nrcthen Colmar Tallahassee, FL 32399-3265 DATE 2\2\% Florida Bar # 0169889 (850) 414-8126 (850) 488-1855 FAX Reviewed and approved by: DEE ( initialsy 722/27 (date) pep, fat/oS PCP Members: Novel ¥ Lluarey Stanley Dyen, R.Ph.; DOH Case # 2003-06550 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. Vl

Docket for Case No: 06-002881PL