STATE OF FLORIDA DEPARTMENT OF HEALTH

Transcription

1 DEPARTMENT OF HEALTH, STATE OF FLORIDA DEPARTMENT OF HEALTH PETITIONER, v. CASE NO VITAL RX, INC., 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, Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding, 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 Administrative Complaint, Respondent was a permitted Special Sterile Compounding Pharmacy (SSCP) within the state of Florida, having been issued permit number PH Respondent's address of record is 1000 E. Atlantic Boulevard, Suite 110, Pompano Beach, Florida

2 4. Compounded Sterile Products (CSP) are defined by Section (20), Florida Statutes (2017) as a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug or product that is required to be sterile under federal or state law or rule, which is produced through compounding, but is not approved by the United States Food and Drug Administration (FDA). 5. High-risk level CSPs are either contaminated or at a high-risk of becoming contaminated before sterilization. Contaminated CSPs are most hazardous to patients when administered into body cavities, central nervous and vascular systems, eyes, and joints. 6. Pharmacies which prepare high-risk level CSPs have the responsibility of ensuring that the procedures, techniques, ingredients, devices, and equipment used to prepare CSPs conform to the requirements of the United States Pharmacopeia (USP), Chapter Respondent engaged in the compounding of high-risk CSPs. 8. On or about June 13, 2017, inspectors with the Department of Health conducted a routine special sterile compounding inspection of Respondent. 9. At the time of the inspection, Respondent did not employ any pharmacist with training or experience in sterile compounding. Administrative Complaint Page 2 of 20

3 10. Respondent released CSPs to the public without a visual examination for the presence of particulate matter. 11. All CSPs that are intended to be solutions must be visually examined for the presence of particulate matter and must not be administered and/or dispensed when such matter is observed. CSPs with observed defects are to be immediately discarded or marked and segregated from acceptable products in a manner that prevents their administration. 12. A vial of calcium gluconatel, lot number , was observed by inspectors to be contaminated by large particles of foreign matter. 13. Respondent dispensed the contaminated calcium gluconate to the public. Respondent failed to notify the public, and/or recall the contaminated product. 14. The USP requires that all compounding employees shall be properly trained for the type of compounding conducted by them, to ensure that they are capable of compounding sterile products without introducing microorganisms into the final product. 15. The USP also requires that all training activities of compounding employees shall be documented. This training includes, but is not limited to, 1 Calcium gluconate is a mineral supplement and medication, used by injection into a vein to treat low blood calcium, high blood potassium, and magnesium toxicity. Administrative Complaint Page 3 of 20

4 direct supervision by a qualified compounding pharmacist, until the ability to repeat procedures without assistance is demonstrated by the employee. 16. At all times material to his Complaint, Respondent employed a pharmacy technician, A.S., who compounded CSPs. 17. A.S. does not have the requisite training and/or experience to compound CSPs. 18. A.S. was not supervised by a qualified compounding pharmacist properly trained in sterile compounding techniques. 19. A.S. failed to demonstrate capability of compounding sterile products without introducing microorganisms into the final product. 20. The USP requires that filter units used to sterilize CSPs shall be subjected to manufacturers' recommended integrity test, such as the bubble point test A.S. failed to demonstrate proper execution of the bubble point test, or other recommended integrity tests, when she placed the filter on the wrong end of the device. 2 The bubble-point test, also known as a filter integrity test, measures the minimum pressure required to overcome the capillary forces which hold a wetting liquid within a filter's pore structure. This test helps ensure that the sterilizing filter used is effective in filtering out microorganisms. Administrative Complaint Page 4 of 20

5 22. The USP requires an aseptic work practice assessment and evaluation via personnel glove fingertip sampling Respondent failed to properly document A.S.'s completion of the required gloved fingertip/thumb sampling procedure, prior to compounding CSPs for human use. 24. The USP requires compounding personnel to undergo media-fill testing,4 and that media-fill tests shall represent the most challenging or stressful conditions actually encountered by the personnel being evaluated when they prepare low-and medium-risk level CSPs and when sterilizing highrisk level CSPs. 25. A.S.'s media-fill tests did not replicate the most challenging/stressful batch. 3 "Sampling of compounding personnel glove fingertips shall be performed for all CSP risk level compounding because direct touch contamination is the most likely source of introducing microorganisms into CSPs prepared by humans. Glove fingertip sampling shall be used to evaluate the competency of personnel in performing hand hygiene and garbing procedures in addition to educating compounding personnel on proper work practices, which include frequent and repeated glove disinfection using sterile 70% IPA during actual compounding of CSPs. All personnel shall demonstrate competency in proper hand hygiene and garbing procedures and in aseptic work practices (e.g., disinfection of component surfaces, routine disinfection of gloved hands)." Chapter 797, USP. 4 Pursuant to Chapter 797, USP: The skill of personnel to aseptically prepare CSPs shall be evaluated using sterile fluid bacterial culture media-fill verification, (i.e., sterile bacterial culture medium transfer via a sterile syringe and needle). Media-fill testing is used to assess the quality of the aseptic skill of compounding personnel. Media-fill challenge tests are also used to verify the capability of the compounding environment and processes to produce sterile preparations. 5 Media-fill tests are performed to test aseptic technique. Aseptic technique is used to reduce the chance of contamination from pathogens. All compounding personnel shall have their aseptic technique and related practice competency evaluated initially during the media-fill test procedure and subsequent annual or semiannual media-fill test procedures on the Sample Form for Assessing Aseptic Technique and Related Practices of Compounding Personnel Administrative Complaint Page 5 of 20

6 26. Respondent used a Sterivex SVGP01050 and a Meissner Stylux GSST0.2, sterilizing membrane filters. 27. The documentation for the Sterivex SVGP01050 filter indicated that it is for laboratory rather than pharmaceutical use, and Respondent failed to document that it passed the bacterial challenge test Documentation for the Meissner Stylux GSST0.2 filter indicated that the filter passed sterility assurance testing with a bubble point of twenty (20) pounds per square inch. The Meissner Stylux GSST0.2 should have a bubble point greater than forty-four (44) pounds per square inch. 29. Chapter 797 of the USP provides that Viable Air Sampling (VAS)7 shall be performed by properly trained individuals. 30. A.S. performed VAS for Respondent. A.S. is not properly trained and/or Respondent did not have documentation indicating A.S. was properly trained to perform VAS. 31. Respondent's documentation for VAS did not indicate testing dates or media information. 6 The bacterial challenge test validates the ability of a filter to provide sterile effluent in a specific pharmaceutical liquid. 7 VAS is the evaluation of airborne microorganisms using volumetric collection methods in controlled air environments. Administrative Complaint Page 6 of 20

7 32. The USP requires that Respondent shall conduct surface sampling Respondent failed to conduct and/or failed to document conducting surface sampling. 34. The USP provides that glass and metal devices used in the compounding of CSPs be covered tightly with aluminum foil, then exposed to dry heat in an oven to achieve sterility and depyrogenation, and that such items should either be used immediately or stored until use in an environment suitable for compounding Low-Risk and Medium-Risk Level CSPs. 35. Respondent stored vials, used for final compounded products, wrapped in aluminum foil in an environment unsuitable for low risk/medium risk level compounding. 36. Respondent stored glassware, used to compound non-sterile products, in an environment unsuitable for low risk/medium risk level compounding. 37. The USP provides that hazardous drugs9 shall be prepared for administration only under certain conditions, that they shall be stored 8 Surface sampling is an important component of the maintenance of a suitable microbially controlled environment for compounding CSPs, especially since the transfer of microbial contamination from improperly disinfected work surfaces via inadvertent touch contact by compounding personnel can be a potential source of contamination into CSPs. 9 Hazardous drugs include those used for cancer chemotherapy, antiviral drugs, hormones, some bioengineered drugs, and other miscellaneous drugs. Administrative Complaint Page 7 of 20

8 separately from other inventory to prevent contamination and personnel exposure, and that the storage area for them should have sufficient general exhaust ventilation. 38. The USP further provides that hazardous drugs shall be prepared in a negative pressure environment with protective engineering controls in place, that access to them shall be limited to areas where drugs are stored and prepared to protect persons not involved in drug preparation, and that appropriate personnel protective equipment (PPE)10 shall be worn when compounding Hazardous Drugs. 39. A prescription for Human Chorionic Gonadotropin (HCG),11 a hazardous drug, was located by inspectors, indicating that Respondent was compounding this drug. 40. Respondent does not have a negative pressure room in which to compound hazardous drugs or other equipment/ppe required for compounding hazardous drugs. COUNT I 10 PPE should include gowns, face masks, eye protection, hair covers, shoe covers or dedicated shoes, double gloving with sterile chemo-type gloves, and compliance with manufacturers' recommendations. 11 HCG is a Hazardous Drug, due to its potential for reproductive toxicity and teratogenicicity. Many hazardous drugs have sufficient vapor pressures that allow volatilization at room temperature. Administrative Complaint Page 8 of 20

9 41. Petitioner re-alleges and incorporates paragraphs one (1) through forty (40), as if fully set forth herein. 42. Section (1)(c), Florida Statutes ( ), subjects a pharmacy permittee to discipline, when the permittee or any affiliated person, partner, officer, director, or agent of the permittee, violates any of the requirements of Chapter 465, Florida Statutes, or the Rules of the Board of Pharmacy. 43. Section (1)(r), Florida Statutes ( ), subjects a pharmacy permittee to discipline, for violations of Chapter 465 or Chapter 456, Florida Statutes ( ), or any rules adopted pursuant thereto. 44. Rule (1)(a), Florida Administrative Code, provides, in relevant part, that all sterile compounding shall be performed in accordance with the minimum practice and quality standards of the following chapters of the United States Pharmacopeia ("USP"), 36th revision, Second Supplement, incorporated and adopted by reference with the effective chapter dates of December 1, 2013: Chapter 797, Pharmaceutical Compounding-Sterile Preparations. 45. Chapter 797 of the USP requires that compounding personnel be adequately skilled, educated, instructed, and trained to correctly perform and document the following activities in their sterile compounding duties: Administrative Complaint Page 9 of 20

10 a. perform antiseptic hand cleansing and disinfection of nonsterile compounding surfaces; b. select and appropriately don protective garb; c. maintain or achieve sterility of CSPs in IS012 Class 5 PEC devices and protect personnel and compounding environments from contamination by radioactive, cytotoxic, and chemotoxic drugs, d. identify, weigh, and measure ingredients; and e. manipulate sterile products aseptically, sterilize high-risk level CSPs, and label and quality inspect CSPs. 46. Chapter 797 of the USP requires that personnel who prepare CSPs shall be trained conscientiously and skillfully by expert personnel and through audio-visual instructional sources and professional publications in the theoretical principles and practical skills of aseptic manipulations, garbing procedures, cleaning and disinfection practices, and in achieving and maintaining ISO Class 5 environmental conditions before they begin to prepare CSPs. Each person assigned to the aseptic area in the preparation of 12 International Organization for Standardization (ISO) Administrative Complaint Page 10 of 20

11 sterile products shall successfully complete specialized training in aseptic techniques and aseptic area practices prior to preparing CSPs. 47. Chapter 797 of the USP requires that CSPs be visually inspected for abnormal particulate matter and color and have intact containers and seals. 48. Chapter 797 of the USP requires that compounding personnel be meticulously conscientious in precluding contact contamination of CSPs both within and outside ISO Class 5 areas. 49. Chapter 797 of the USP requires that compounding personnel rapidly identify and correct deficiencies in compounding. 50. Chapter 797 of the USP requires that a sterile compounding pharmacy develop a written description of specific training and performance evaluation for individuals involved in the use of aseptic techniques for the preparation of sterile products. 51. Chapter 797 of the USP requires that compounding personnel perform didactic review and pass written and media-fill testing of aseptic manipulative skills initially, at least annually thereafter for low- and mediumrisk level compounding, and semiannually for high-risk level compounding. Administrative Complaint Page 11 of 20

12 52. Chapter 797 of the USP requires that filter units used to sterilize CSPs be subjected to the manufacturers' recommended integrity test, such as the bubble point test. 53. Chapter 797 of the USP requires that a pharmacy use glove fingertip sampling to evaluate the competency of personnel in performing hand hygiene and garbing procedures and in aseptic work practices. All personnel shall demonstrate competency in proper hand hygiene and garbing procedures and in aseptic work practices. 54. Chapter 797 of the USP requires that all compounding personnel have their aseptic technique and related practice competency evaluated initially during a media-fill test procedure and subsequent annual or semiannual media-fill test procedures. The pharmacy shall maintain records of these evaluations and a permanent record of and long term assessment of personnel competency. 55. Chapter 797 of the USP requires that compounding supervisor ensure, directly or from appropriate documentation, that the filters are chemically and physically stable at the pressure and temperature conditions to be used, that they have enough capacity to filter the required volumes, and that they will achieve sterility and maintain prefiltration pharmaceutical quality, including strength of ingredients of the specific CSP. Administrative Complaint Page 12 of 20

13 56. Chapter 797 of the USP requires that properly trained individuals evaluate airborne microorganisms using volumetric collection methods in the controlled air environments for all compounding risk levels. 57. Chapter 797 of the USP requires that a sterile compounding pharmacy perform surface sampling in all ISO classified areas on a periodic basis. 58. Chapter 797 of the USP classifies hazardous drugs as drugs where studies in animals or humans indicate that exposures to those drugs have a potential for causing cancer, developmental or reproductive toxicity, or harm to organs. 59. Chapter 797 of the USP requires hazardous drugs to be compounded in their own negative pressure buffer room. 60. As set forth above, Respondent violated Section (1)(c), Florida Statutes ( ), by violating Rule (1)(a), Florida Administrative Code, by: a. allowing unqualified personnel who lacked the appropriate training and experience, to produce CSPs; b. failing to visually inspect a lot of calcium gluconate, prior to dispensing the CSP to the public; Administrative Complaint Page 13 of 20

14 c. failing to prevent contamination of a lot of calcium gluconate and dispensing the contaminated CSP to the public; d. failing to identify and correct the contamination of a lot of calcium gluconate, prior to dispensing to the public; e. failing to recall or notify the public of the contaminated lot of calcium gluconate; f. failing to subject sterilizing membrane filters to an appropriate and competently-performed integrity test; g. failing to document whether personnel completed the required gloved fingertip sampling; h. allowing personnel to produce CSPs without completing the required media-fill test; i. failing to ensure that the sterilizing membrane filters used were chemically and physically compatible with the CSP; j. failing to ensure that the sterilizing membrane filters were chemically and physically stable at the pressure and temperature conditions to be used; k. documenting a sterilizing membrane filter as having passed an integrity test at the wrong bubble-point; I. allowing unqualified personnel to conduct VAS; Administrative Complaint Page 14 of 20

15 m. failing to keep adequate records of VAS; n. failing to conduct and/or document conducting surface sampling; and/or o. failing to maintain a negative pressure environment and use proper equipment and storage when compounding the Hazardous Drug, HCG. 61. Based on the foregoing, Respondent violated Section (1)(c), Florida Statutes ( ), by violating Rule 64E (1)(a), Florida Administrative Code, by failing to comply with the aforementioned requirements of USP Chapter 797. COUNT II 62. Petitioner realleges and incorporates paragraphs one through forty (40), as if fully set forth herein. 63. Section (1)(k), Florida Statutes ( ), provides that failing to perform any statutory or legal obligation placed upon a licensee constitutes grounds for disciplinary action. 64. Section (1)(c), Florida Statutes ( ), provides that violating any of the requirements of this chapter or any of the rules of the Board of Pharmacy; of chapter 499, known as the "Florida Drug and Cosmetic Act"; of 21 U.S.C. ss , known as the "Federal Food, Drug, Administrative Complaint Page 15 of 20

16 and Cosmetic Act"; of 21 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse Prevention and Control Act; or of chapter 893, constitutes grounds for discipline. 65. Section , Florida Statutes ( ), provides that it is unlawful for a person to perform or cause the performance of the following acts: a. (1) The manufacture, repackaging, sale, delivery, or holding or offering for sale of any drug, device, or cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use. b. (2) The adulteration or misbranding of any drug, device, or cosmetic. c. (4) The Sale, distribution, purchase, trade, holding, or offering of any drug, device, or cosmetic in violation of this part. 66. Section , Florida Statutes ( ), provides that a drug or device is adulterated, if any of the following apply: a. (1) It consists in whole or in part of any filthy, putrid, or decomposed substance; Administrative Complaint Page 16 of 20

17 b. (2) It has been produced, prepared, packed, or held under conditions whereby it could have been contaminated with filth or rendered injurious to health; and/or c. (3) It is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, current good manufacturing practices to assure that the drug meets the requirements of this part and that the drug has the identity and strength, and meets the standard of quality and purity, which it purports or is represented to possess. 67. As set forth above, Respondent violated Section (1)(k), Florida Statutes ( ), through a violation of Section (1)(c), Florida Statutes ( ), by violating Section (1),(2) and/or (4), Florida Statutes ( ), by: a. Manufacturing, repackagaing, selling, delivering, and/or holding or offering for sale vial(s) of calcium gluconate, lot number , which were: Administrative Complaint Page 17 of 20

18 i. produced, prepared, packed, or held under conditions whereby their contamination with filth and/or their being rendered injurious to health were likely; ii. contaminated by large particles of foreign matter; iii. not visually inspected prior to being dispensed to the public; and/or iv. dispensed to the public with contaminants present; b. Adulterating or misbranding vial(s) of calcium gluconate, lot number ; and/or c. Selling, distributing, purchasing, trading, holding, or offering vial(s) of calcium gluconate, lot number , in violation of this part. 68. Based on the foregoing, Respondent violated Section (1)(k), Florida Statutes ( ), by and through a violation of Section (1)(c), Florida Statutes ( ), by violating Section (1), (2) and/or (4), Florida Statutes ( ). 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, Administrative Complaint Page 18 of 20

19 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. SIGNED this 28th day of September Celeste Philip, MD, MPH State Surgeon General and Secretary 1st Lindsey H. Frost LINDSEY H. FROST Assistant General Counsel Fla. Bar No Florida Department of Health Office of the General Counsel 4052 Bald Cypress Way, Bin #C65 Tallahassee, FL Telephone: (850) Facsimile: (850) FILED DEPARTMENT OF REAM DEPUTY CLERK CLERK: DATE C9.1174::: SEP PCP: 09/21/2017 PCP Members: Mikhael & Alvarez Administrative Complaint Page 19 of 20

20 NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section and , 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. A request or petition for an administrative hearing must be in writing and must be received by the Department within 21 days from the day Respondent received the Administrative Complaint, pursuant to Rule (2), Florida Administrative Code. If Respondent fails to request a hearing within 21 days of receipt of this Administrative Complaint, Respondent waives the right to request a hearing on the facts alleged in this Administrative Complaint pursuant to Rule (4), Florida Administrative Code. Any request for an administrative proceeding to challenge or contest the material facts or charges contained in the Administrative Complaint must conform to Rule (5), Florida Administrative Code. Please note that mediation under Section , Florida Statutes, is not available to resolve this Administrative Complaint. 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 (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. Administrative Complaint Page 20 of 20