DEPARTMENT OF HEALTH, STATE OF FLORIDA DEPARTMENT OF HEALTH PETITIONER, v. CASE NO. 2017-07415 SAMER SHEHAITA, RESPONDENT. ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health (Department), by and through its undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy against Respondent, Samer Shehaita, 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 Administrative Complaint, Respondent was a licensed pharmacist within the state of Florida, having been issued license number PS28842.
3. Respondent's address of record is 33048 US Highway 27, Haines City, Florida 33844. 4. At all times material to this Administrative Complaint, Respondent was the prescription department manager (PDM) of record for H C Pharmacy, LLC ("the Permitteel, a permitted community pharmacy located in Haines City, Florida. 5. On or about April 25, 2017, a Department inspector presented to the Permittee's address of record to conduct an inspection, 6. The inspection revealed that M.G., an unlicensed individual employed by the Permittee, was performing the duties of a registered pharmacy technician in the Permittee's prescription department 7. The inspection revealed that Respondent, as PDM of record for the Permittee, did not maintain written policy and procedures regarding the number of registered pharmacy technician positions and the specific scope of delegable tasks and job descriptions for the registered pharmacy technicians. 8. The inspection revealed that the Permittee did not maintain written policies and procedures regarding the establishment of a DOH v. Samer Shehaita, R.Ph. 2
continuous quality improvement (CQI) program and provisions for a CQI committee made up of staff members of the pharmacy. 9. The inspection revealed that the Permittee did not maintain written evidence of attendance by the CQI committee to reviews of quality related events held at least every three months. 10. The inspection revealed that the Permittee's compounding records for one or more nonsterile compounded preparations were missing original manufacturer's lot number and expiration dates for one or more active pharmaceutical ingredients. COUNT ONE 11. Petitioner realleges and incorporates paragraphs one through ten as if fully set forth herein. 12. Section 456.072(1)(j), Florida Statutes (2016), provides that aiding, assisting, procuring, employing, or advising any unlicensed person or entity to practice a profession contrary to this chapter, the chapter regulating the profession, or the rules of the department or the board. 13. Section 465.014(1), Florida Statutes (2016), provides that a person other than a licensed pharmacist or pharmacy intern may not engage in the practice of the profession of pharmacy, except that a DOH v. Samer Shehaita, R.Ph. 3
licensed pharmacist may delegate to pharmacy technicians who are registered pursuant to this section those duties, tasks, and functions that do not fall within the purview of s. 465.003(13). All such delegated acts must be performed under the direct supervision of a licensed pharmacist who is responsible for all such acts performed by persons under his or her supervision. A registered pharmacy technician, under the supervision of a pharmacist, may initiate or receive communications with a practitioner or his or her agent, on behalf of a patient, regarding refill authorization requests. A licensed pharmacist may not supervise more than one registered pharmacy technician unless otherwise permitted by the guidelines adopted by the board. The board shall establish guidelines to be followed by licensees or permittees in determining the circumstances under which a licensed pharmacist may supervise more than one pharmacy technician. 14. Respondent employed, assisted, aided, procured, or advised M.G., an unlicensed individual, to perform the duties of a registered pharmacy technician contrary to the provisions of Section 465.014(1), Florida Statutes. DOH v. Samer Shehaita, R.Ph. 4
15. Based on the foregoing, Respondent has violated Section 456.072(1)(j), Florida Statutes (2016). COUNT TWO 16. Petitioner realleges and incorporates paragraphs one through ten as if fully set forth herein. 17. Section 456.072(1)(k), Florida Statutes (2016), provides that failing to perform any statutory or legal obligation placed upon a licensee constitutes grounds for disciplinary action. 18. Rule 64B16-27.410(2)(a), Florida Administrative Code, provides that regardless of the technician ratio, every pharmacy, pharmacist, Prescription Department Manager (PDM) and Consultant Pharmacist (CP) that employs or utilizes registered pharmacy technicians must comply with the following conditions: (a) Establish and maintain a written Policy and Procedures Manual regarding the number of registered pharmacy technician positions and their utilization that includes the specific scope of delegable tasks of the technicians, job descriptions, and task protocols. 19. Respondent's, as PDM of record for the Permittee, failed to establish and maintain a written policy and procedures manual regarding the number of registered pharmacy technician positions and their utilization DOH v. Samer Shehaita, R.Ph. 5
that includes the specific scope of delegable tasks of the technicians, job descriptions, and task protocols. 20. Based on the foregoing, Respondent has violated Section 456.072(1)(k), Florida Statutes (2016), by failing to perform a legal or statutory obligation as set forth by Rule 64616-27.410(2)(a), Florida Administrative Code. COUNT THREE 21. Petitioner realleges and incorporates paragraphs one through ten as if fully set forth herein. 22. Section 456.072(1)(k), Florida Statutes (2016), provides that failing to perform any statutory or legal obligation placed upon a licensee constitutes grounds for disciplinary action. 23. Section 465.022(11)(a), Florida Statutes (2016), provides that the prescription department manager must ensure the permitteefs compliance with all rules adopted under those chapters as they relate to the practice of the profession of pharmacy and the sale of prescription drugs. 24. Rule 64616-27.300(3)(a), Florida Administrative Code, provides that each pharmacy shall establish a Continuous Quality Improvement DOH v. Samer Shehaita, R.Ph. 6
Program which program shall be described in the pharmacy's policy and procedure manual and, at a minimum shall contain: 1. Provisions for a Continuous Quality Improvement Committee that may be comprised of staff members of the pharmacy, including pharmacists, registered pharmacy interns, registered pharmacy technicians, clerical staff, and other personnel deemed necessary by the prescription department manager or the consultant pharmacist of record; 2. Provisions for the prescription department manager or the consultant pharmacist of record to ensure that the committee conducts a review of Quality Related Events at least every three months. 3. A planned process to record, measure, assess, and improve the quality of patient care; and 4. The procedure for reviewing Quality Related Events. 25. Respondent, as PDM of record, failed to ensure that the Permittee maintain written policies and procedures regarding the establishment of a CQI program and provisions for a CQI committee made up of staff members of the pharmacy. 26. Respondent, as PDM of record, failed to ensure that the Permittee maintain written evidence of attendance by the CQI committee to reviews of quality related events held at least every three months. DOH v. Samer Shehaita, R.Ph. 7
27. Based on the foregoing, Respondent has violated Section 456.072(1)(k), Florida Statutes (2016), by failing to perform a legal or statutory obligation as set forth by Section 465.022(11)(a), Florida Statutes (2016), by failing to ensure the Permittee's compliance with Rule 64B16-27.300(3)(a), Florida Administrative Code. COUNT FOUR 28. Petitioner realleges and incorporates paragraphs one through ten as if fully set forth herein. 29. Section 456.072(1)(k), Florida Statutes (2016), provides that failing to perform any statutory or legal obligation placed upon a licensee constitutes grounds for disciplinary action. 30. Section 465.022(11)(a), Florida Statutes (2016), provides that the prescription department manager must ensure the permittee's compliance with all rules adopted under those chapters as they relate to the practice of the profession of pharmacy and the sale of prescription drugs. 31. Rule 64B16-28.140(4)(b), Florida Administrative Code, provides that a written record shall be maintained for each batch/sub-batch of a compounded product under the provisions of Rule 64B16-27.700, F.A.C. DOH v. Samer Shehaita, R.Ph. 8
This record shall include [a] control number for each batch/sub-batch of a compounded product. This may be the manufacture's lot number or new numbers assigned by the pharmacist. If the number is assigned by the pharmacist, the pharmacist shall also record the original manufacture's lot number and expiration dates. If the original numbers and expiration dates are not known, the pharmacy shall record the source and acquisition date of the component. 32. Respondent, as PDM of record, failed to ensure that the Permittee's compounding records for one or more nonsterile compounded preparations contained original manufacturer's lot number and expiration dates for one or more active pharmaceutical ingredients. 33. Based on the foregoing, Respondent has violated Section 456.072(1)(k), Florida Statutes (2016), by failing to perform a legal or statutory obligation as set forth by Section 465.022(11)(a), Florida Statutes (2016), by failing to ensure the Permittee's compliance with Rule 64E316-28.140(4)(b), Florida Administrative Code. DOH v. Samer Shehaita, R,Ph. 9
WHEREFORE, the 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 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 VC1 day of Se 'epa1,tr, 2017. Celeste Philip, M.D., M.P.H. Surgeon General and Secretary FILED DEPARTMENT OF HEALTH DEPUTY CLERK CLERK: 64;,11, C0,4.07 DATE q -ri-x IT. CHRISTOPH R A. JURICH Assistant General Counsel Fla. Bar No. 0099014 Florida Department of Health Office of the General Counsel 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265 Telephone: (850) 558-9861 Facsimile: (850) 245-4662 Email: christopher.jurich@flhealth.gov PCP Meeting: September 7, 2017 PCP Members: Jeenu Philip, Debra Glass DOH v. Samer Shehaita, R.Ph. 10
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. 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 28-106.111(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 28-106.111(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 28-106.2015(5), Florida Administrative Code. Please note that mediation under Section 120,573, 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 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. DOH v. Samer Shehaita, R.Ph. 11