Regulating Pharmacy Technicians Allison Benz, R.Ph., M.S. Director of Professional Services and Nelma Sanchez, C.Ph.T. Enforcement Program Officer Pharmacy Technician Seminar Series April 14, 2012 Texas Pharmacy Act - Purpose Promote, preserve, and protect the public health, safety, and welfare through: Effectively controlling and regulating the practice of pharmacy. Licensing pharmacies engaged in the sale, delivery, or distribution of prescription drugs and devices used in diagnosing and treating injury, illness, and disease. 2 Board of Pharmacy Membership Nine members appointed by the Governor, with the advice and consent of the Senate to serve 6-year terms. Six members are pharmacists. Three members are consumers and represent the public. 3 Texas State Board of Pharmacy 1
Board of Pharmacy Members Jeanne D. Waggener, R.Ph. - President, Waco Dennis F. Wiesner, R.Ph. - Vice-President, Austin Buford T. Abeldt, Sr., R.Ph., - Treasurer, Lufkin W. Benjamin Fry, R.Ph. - San Benito L. Suzan Kedron - Dallas Alice G. Mendoza, R.Ph. - Kingsville Phyllis Stine - Abilene Joyce A. Tipton, R.Ph. - Houston Charles F. Wetherbee - Boerne 4 The Board/Agency The Board 9 members 6 Pharmacist Members and 3 Consumer Members Set policies Staff 78 FTEs Advise the Board on policy considerations Implement policies 6 Texas State Board of Pharmacy 2
Texas State Board of Pharmacy Organizational Chart Rick Perry Governor 9 Board Members Gay Dodson, R.Ph. Executive Director/Secretary Cathy Stella, PHR Director Administrative Services and Licensing Division Allison Benz, R.Ph., M.S. Director Professional Services Division Carol Fisher, R.Ph., M.P.A. Director Enforcement Division Kerstin Arnold, J.D. General Counsel/Director Legal Division 7 Employees 19 employees are pharmacy technicians (24%) 7 employees are pharmacists (9%) 52 employees are other 8 Pharmacy Technician Employees (cont.) Compliance Inspectors (5) Performs inspections of pharmacies to ensure compliance with laws and rules governing the practice of pharmacy. Compliance Specialist (1) Provides technical support to field Compliance Staff and analyzes responses to Warning Notices. Liaison to field Compliance Staff. 9 Texas State Board of Pharmacy 3
Pharmacy Technician Employees (cont.) Enforcement (11) In-house investigations involving pharmacy technicians Monitor pharmacists and pharmacy technicians subject to disciplinary orders Field investigator Administrative duties Supervisor 10 Pharmacy Technician Employees (cont.) Legal (2) Legal assistants to attorneys 11 Rules for Pharmacy Technicians in Hospital Pharmacies 12 Texas State Board of Pharmacy 4
Duties of the Pharmacist The following duties may only be performed by a pharmacist: Providing acts or services necessary to provide pharmaceutical care; receiving, interpreting, and evaluating prescription drug orders, and reducing verbal medication orders to writing either manually or electronically; 13 Duties of the Pharmacist (cont.) participating in drug and/or device selection as authorized by law, drug and/or device supplier selection, drug administration, drug regimen review, or drug or drug-related research; performing a specific act of drug therapy management for a patient delegated to a pharmacist by a written protocol from a physician licensed in this state in compliance with the Medical Practice Act Subtitle B, Chapter 157, Occupations Code; 14 Duties of the Pharmacist (cont.) accepting the responsibility for: distributing prescription drugs and devices with drug components pursuant to medication orders; compounding and labeling of prescription drugs and devices with drug components; proper and safe storage of prescription drugs and devices with drug components; and maintaining proper records for prescription drugs and devices with drug components. 15 Texas State Board of Pharmacy 5
Tech-Check-Tech Rules Effective Date: March 10, 2010. The amendments to the Class C rules implement the provisions of H.B. 1924 relating to one technician checking the work of another technician. H.B. 1924 specifies that hospitals that have ongoing clinical pharmacy programs may allow pharmacy technicians to verify the accuracy of work performed by another pharmacy technician relating to the filling of floor stock and unit dose distribution systems if the patient's orders have previously been reviewed and approved by a pharmacist. (Tech-Check-Tech). 16 Tech-Check-Tech Rules (cont.) 17 A Clinical Pharmacy Program is defined as: An ongoing program in which pharmacists provide direct focused, medication-related care for the purpose of optimizing patients' medication therapy and achieving definite outcomes, which includes the following activities: Prospective medication therapy consultation, selection, and adjustment; Monitoring laboratory values and therapeutic drug monitoring; Identifying and resolving medication-related problems; and Disease state management. Tech-Check-Tech Rules (cont.) Technicians must be trained in the: Procedures for one technician to verify the accuracy of actions performed by another technician including required documentation; and The duties that may be performed by one technician and checked by another technician. The patient's orders must have been reviewed and approved by a pharmacist. 18 Texas State Board of Pharmacy 6
Tech-Check-Tech Rules (cont.) 19 Duties: Filling medication carts; Distributing routine orders for stock supplies to patient care areas; and Accessing and restocking automated medication supply systems after: Proper training on the use of the automated medication supply system; and Demonstration of comprehensive knowledge of the written policies and procedures for its operation. Tech-Check-Tech Rules (cont.) Notification Requirements: The PIC must submit an application on a form provided by the Board, containing the following information: Pharmacy name, address, and license number; Name and license number of the PIC; Name and registration numbers of the pharmacy technicians; Date the pharmacy plans to begin allowing a Tech-Check- Tech; Documentation of an ongoing clinical pharmacy program; and Any other information specified on the application. 20 Rural Hospital Rules 21 Effective Date: May 30, 2010 Amendments to the Class C rules implement the provision of H.B. 1924 (Heflin/Seliger) regarding rural hospitals. A "rural hospital" is a hospital with 75 beds or fewer that: Is located in a county with a population =/< 50,000; or Has been designated by the Centers for Medicare and Medicaid Services as a critical access hospital, rural referral center, or sole community hospital. Texas State Board of Pharmacy 7
Rural Hospitals Rules (cont.) 22 Pharmacy technicians in a rural hospital are allowed to perform certain duties when a pharmacist is NOT on duty if: The pharmacy technician is registered and meets the training requirements specified by the Board. A pharmacist is accessible at all times to respond to any questions and needs of the pharmacy technician or other hospital employees. A nurse or practitioner or a pharmacist by remote access verifies the accuracy of the actions of the pharmacy technician. Rural Hospitals Rules (cont.) 23 In a rural hospital a pharmacy technician may perform the following duties without the direct supervision of a pharmacist: Enter medication order and drug distribution information into a data processing system. Prepare, package, or label a prescription drug if a licensed nurse or practitioner verifies the accuracy of the order before administration to the patient. Fill medication carts. Distribute routine orders for supplies to patient care areas. Access and restock automated medication supply systems. Rural Hospitals Rules (cont.) A rural hospital that wishes to allow a technician to perform duties without the direct supervision of a pharmacist must make application to the Board as follows. Prior to allowing a technician to perform duties without the direct supervision of a pharmacist, the PIC must submit an application to the Board. Pharmacy technicians may not perform duties without direct supervision until the Board has reviewed and approved the application and issued an amended license. 24 Texas State Board of Pharmacy 8
Rural Hospitals Rules (cont.) Every two years in conjunction with the application for renewal of the pharmacy license, the PIC must update the application for pharmacy technicians to perform duties without the direct supervision of a pharmacist. 26 Rural Hospitals Rules (cont.) 27 A pharmacy technician must make a record of all drugs distributed from the pharmacy in the absence of the pharmacist The pharmacist must: Verify and document the verification of all distributions made from the pharmacy in the absence of a pharmacist; Perform a drug regimen review for all medication orders and document the verification including any discrepancies; Review any discrepancy with the pharmacy technician and make any change in procedures or processes necessary to prevent future problems; and Report any adverse events that have a potential for harm to a patient to the appropriate committee of the hospital. Texas State Board of Pharmacy 9
Duties of Pharmacy Technicians Pre-package and label unit and multiple dose packages Prepare, package, compound, or label prescription drugs pursuant to medication orders Compound batch preparations Distribute routine orders for stock supplies to patient care areas 28 Duties of Pharmacy Technicians (cont.) Enter medication order and drug distribution information into a data processing system Load unlabeled drugs into an automated compounding or counting device Access and restock automated medication supply systems Compound non-sterile preparations 29 Duties of Pharmacy Technicians (cont.) Compound low-risk sterile preparations (after completing the required 40 hour training) Compound medium-risk and high-risk sterile preparations (after completing the required 40 hour training) Fill medication carts 30 Texas State Board of Pharmacy 10
Common Problems in Hospital Pharmacies 31 Compliance Inspections of Class C (Hospital) Pharmacies 2,492 inspections during FY2011 377 were Class C pharmacies 161 non-compliance issues 32 Most Common Non-Compliance Issues In Class C Pharmacies (FY2011) 33 Texas State Board of Pharmacy 11
Non-Compliance Issues Improper documentation of training includes failure to maintain documentation of initial pharmacy technician training, in-service training, sterile products training, rural hospital, and tech-check-tech 34 Non-Compliance Issues (cont.) Improper absence of pharmacist procedures includes failure to maintain proper records with regard to distribution of medications when a pharmacist is not present 35 Non-Compliance Issues (cont.) Licenses not posted in pharmacy 36 Texas State Board of Pharmacy 12
Non-Compliance Issues (cont.) Improper supervision of pharmacy technicians (or supportive personnel) includes pharmacy technicians performing duties of a pharmacist or performing duties of a pharmacy technician without the supervision of a pharmacist 37 Pharmacy Technician/Trainee Registration Pharmacy technicians must: be registered BEFORE they begin work; POST their registration certificate in the pharmacy; (exception) and renew their registration every 2-years and they CANNOT work with a delinquent registration. 38 Note: Pharmacy technician trainee registrations expire after 2-years and cannot be renewed. Other Rules 39 All pharmacy technicians must wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician, or a certified pharmacy technician, if the technician maintains current certification with the Pharmacy Technician Certification Board or any other entity providing an examination approved by the board. All pharmacy technician trainees shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician trainee. Texas State Board of Pharmacy 13
Other Rules - 297.9 Notifications (cont.) 40 Change of address/employment. Must notify the Board electronically or in writing within 10 days, giving the old and new address/employment and registration number. Change of name. Must notify the in writing within 10 days by: sending a copy of the official document reflecting the name change (e.g., marriage certificate, divorce decree, etc.); returning the current renewal certificate which reflects the previous name; and paying a fee of $20. Other Rules - 297.3 (cont.) An individual may use the title "Registered Pharmacy Technician" or "Ph.T.R." if the individual is registered as a pharmacy technician in this state. 41 www.tsbp.state.tx.us TSBP Website Texas State Board of Pharmacy 14
April 14, 2012 43 44 45 Texas State Board Texas State Board of Pharmacy July 14, 15
46 47 Questions? Thank You! Texas State Board of Pharmacy 16