REGISTERED PHARMACY TECHNICIANS: REQUIREMENTS & REGULATIONS UPDATE Zipporah-Darvi W. Redding A.S., RPhT, CPhT Lead Adherence Technician UF College of Pharmacy MTM CCC Owner of Prime Care Solutionz LLC zipporah.dr@gmail.com I have no vested interest in or affiliation with any other corporate organization offering financial support for this continuing education activity. DISCLAIMER OBJECTIVES FOR PHARMACISTS Discuss Pharmacist to Tech ratio Define Registration and Certification Demonstrate multiple strategies regarding workflow 1
OBJECTIVES FOR PHARMACY TECHNICIANS Review laws and statues of FL regarding registered pharmacy technicians Recognize advantages of expanded technician roles to assist pharmacists Distinguish between judgmental and non judgmental tasks in pharmacy List methods to keep up with requirements SELF-ASSESSMENT QUESTIONS 1. GN is a pharmacy technician from Georgia relocating to Florida, GN has to register with FL DOH before beginning to work as a technician in FL? True/False 2. Registered Pharmacy Technicians i required continuing i education include 1 hour of law, 4 hours of medication errors, and 2 hours live? True/False 3. The pharmacist to tech ratio is 6:1 regardless of the practice setting? True/False 4. All Continuing Education courses must be entered in CE Broker? True/False 5. Pharmacists are responsible for verifying staff s licensure? True/False Pharmacy THE Technicians JOURNEY play OF a PHARMACY vital role in TECHNICIANS the pharmacy profession assisting Licensed Pharmacists by working directly under their supervision; Pharmacy Technicians are instrumental with many different tasks including verifying the legibility of prescriptions, filling prescriptions, placing orders, and assisting in activities not requiring judgment of a pharmacist to help patients, etc. Pharmacy Technicians have to maintain FL Registration in order to perform duties. Pharmacy Technicians are recognized as Health Care Professionals. 2
BACKGROUND - INITIAL 2008 Legislative i l i Process Regulatory Process Board of Pharmacy Regulations (See SB1360) BACKGROUND REQUIRED REGISTRATION 2011 Grandfather h period expired Thousands of revoked registrants Understanding CE requirements BACKGROUND WHERE ARE WE NOW? 2015 2 renewal cycles passed Pharmacist to Tech Ratio update Thousands of Null/Void records 3
WHY REGISTRATION? Accountability Rules Prevention of Errors Continuing Education Regulations Liability Credentials WHAT S IN THE NUMBER? As of 11/28/2015 there are 37,608 active registered pharmacy technicians As of 11/28/2015 there are 25,796 delinquent & null/void records Source: 1. www.flhealthsource.gov ASSESSMENT QUESTION #1 Any person performing the duties of a pharmacy technician must be registered with the Florida Board of Pharmacy? a. Yes b. No 4
GOVERNING LAWS & REGULATIONS Florida Pharmacy Laws (Statutes) Chapter 465 Florida Pharmacy Act Chapter 893 Florida Comprehensive Drug Abuse Prevention and Control Act Chapter 120 Administrative Procedures Act Chapter 499 Florida Drug, Device and Cosmetics Act Chapter 456 Health Professions and Occupations Florida Pharmacy Regulations (Rules) Chapter 64B-16 Board of Pharmacy Chapter 61N-1 Drugs, Devices and Cosmetic Program Chapter 64K-1 Prescription Drug Monitoring Program 465.014-Pharmacy Technician 465.015-Violations and Penalties FOLLOWING THE LAW AND RULES 465.019-Institutional Pharmacies 465.0196-Special Pharmacy Permits 465.0197-Internet Pharmacy Permits 64B16-26.103-Continuing Education Credits; Renewal 64B16-26.350-Requirements 6 for Pharmacy Technician Registration 64B16-26.351-Standards for Approval of Registered Pharmacy Technician Programs 64B16-26.355-Subject Matter for Registered Pharmacy Technician CE 64B16-27.100-Display of Current License: Pharmacist, Intern, and Registered Pharmacy Technician 64B16-27.410-Registered Pharmacy Technician to Pharmacist Ratio 64B16-27.420-Registered Pharmacy Technician Responsibilities 64B16-27.430-Responsibilities of the Pharmacist 64B16-27.440-Policies and Procedures 465.014-PHARMACY TECHNICIAN A person other than a licensed pharmacist or pharmacy intern may not engage in the practice of the profession of pharmacy Certain tasks and responsibilities may be delegated to registered pharmacy technicians Students enrolled in a BOP tech training program do not need to register with the BOP; Interns do not need to register as a tech Anyone wishing to work as a PT must register with the BOP Persons with denied, restricted, or suspended pharmacist license cannot register as a tech Source: 2. www.leg.state.fl.us 5
465.015-VIOLATIONS AND PENALTIES It is unlawful for a person who is not registered as a pharmacy technician under this chapter or who is not otherwise exempt from the requirement to register as a pharmacy technician, to perform the functions of a registered pharmacy technician, or hold himself or herself out to others as a person who is registered to perform the functions of a registered pharmacy technician in this state. Source: 2. www.leg.state.fl.us 465.019-INSTITUTIONAL PHARMACIES & 465.0196-SPECIAL PHARMACY PERMITS Every institutional pharmacy and each permitee that employs or otherwise uses registered pharmacy technicians shall have a written policy and procedures manual specifying those duties, tasks, and functions that a registered pharmacy technician is allowed to perform. Source: 2. www.leg.state.fl.us ASSESSMENT QUESTION #2 Pharmacy interns must register with the FL Board of Pharmacy as a technician in order to work in the pharmacy? a. Yes b. No 6
64B16-26.103-CONTINUING EDUCATION CREDITS; RENEWAL First time renewal; more than 12 months exp 1 Hour HIV/Aids update FL Board approved 2 hours in prevention of medication errors 2 hours live Total of 12 CE hours Biennial Renewal FL Board approved 2 hours in prevention of medication errors 4 hours live Total of 20 CE hours 64B16-26.103-CONTINUING EDUCATION CREDITS; RENEWAL CONTINUED All CE s must be ACPE approved or FL Board approved All Registered Pharmacy Technician CE s must have UAN-T designation Example: 0165-0000-15-121-L03-T Pharmacist renew their licenses on odd years Registered Pharmacy Techs renew their registration on even years Consultant Pharmacist too renew their licenses on even years CONTINUING EDUCATION CREDITS Have you set up your NABP e-profile and registered for CPE monitor? All CE s must be uploaded to CE broker prior to license/registration renewal All CE requirements must be completed prior to renewing 7
64B16-26.350-REQUIREMENTS FOR PHARMACY TECHNICIAN REGISTRATION Applicants must be at least 17 years Applicants must submit a completed application with the BOP in addition to paying fees Applicants must have completed a Board approved training program ASSESSMENT QUESTION #3 LK is a registered pharmacy technician renewing his registration for the second time, what does he need? a. 1 hour law, 2 hours live, 4 hours med errors, 13 general ce s b. 1 hour HIV/Aids update, 2 hours med errors, 2 hours live, 15 general ce s c. 4 hours live, 2 hours med errors, 14 general hours 64B16-26.351-STANDARDS FOR APPROVAL OF REGISTERED PHARMACY TECHNICIAN PROGRAMS The following programs are approved Registered Pharmacy Technician Training programs: American Society of Health-System Pharmacists (ASHP) Southern Association of Colleges and Schools Florida Commission for Independent Education Federal Armed Services Technician Training Programs Council on Occupational Education 8
64B16-26.351-STANDARDS FOR APPROVAL OF REGISTERED PHARMACY TECHNICIAN PROGRAMS CONTINUED Training programs must have been accredited prior to 1/2011, otherwise, Commission for Independent Education pursuant to Chapter 1005, F.S., or the equivalent licensing authority of another state or be within the public school system of the State of Florida 64B16-26.351-STANDARDS FOR APPROVAL OF REGISTERED PHARMACY TECHNICIAN PROGRAMS CONTINUED Employer based programs must meet requirements: Must contain a minimum of 160 hours of training extends over a period not to exceed 6 months Solely provided to employees BOP approved (Application must be submitted for program) Evaluation which includes at minimum 100 questions/70% to pass Employer based programs must meet requirements: Must contain FOLLOWING a minimum THE of 160 LAW hours AND of RULES training extends over a period not to exceed 6 months Solely provided to employees BOP approved (Application must be submitted for program) Evaluation which includes at minimum 100 questions/70% to pass Evidence of academic preparation or experience in the subject matter; including faculty qualifications Responsible person designated (Pharmacist or Pharmacy Technician) Requirements of documentation 9
64B16-26.355-SUBJECT MATTER FOR REGISTERED PHARMACY TECHNICIAN CE (1) Pharmacy technician practice areas and special health care problems. (2) Biological, physical, behavioral and social sciences. (3) Legal aspects of health care. (4) Management/administration of health care personnel and patient care. (5) Teaching/learning process of health care personnel and patients. (6) Subjects which are taken at an accredited educational institution as verified by an official transcript. ASSESSMENT QUESTION #4 Employee based programs can be used for any person as long as they register with the board upon completion? a. True b. False 64B16-27.100-DISPLAY OF CURRENT LICENSE: PHARMACIST, INTERN, AND REGISTERED PHARMACY TECHNICIAN Current licensures shall be displayed in a conspicuous place Easily readable by patrons Licensed and registered staff must be properly identified Name badge/monogramed smock showing credentials (Pharmacist, Registered Intern, Registered Pharmacy Technician) Persons working in secondary practice sites must carry wallet registration card 10
64B16-27.410-REGISTERED PHARMACY TECHNICIAN TO PHARMACIST RATIO Initial Ratio 1:1 (Pharmacy Interns and Student Techs are not in ratio) Unless approved by Board of Pharmacy with a letter of approval of increased ratio which can be readily retrievable for inspection: 3:1-Any pharmacy/pharmacist engaged in sterile compounding shall not exceed a ratio of up to three registered pharmacy technicians 4:1-Any pharmacy/pharmacist may allow this ratio as long as there is no sterile compounding 6:1-A pharmacy which does not dispense medicinal drug as long as delegable tasks do not include sterile compounding 64B16-27.420-REGISTERED PHARMACY TECHNICIAN DELEGABLE TASKS Data Entry Initiating communication with Labeling of preparations and prescriber: prescriptions Retrieval of Rx files, PT files and profiles, plus similar records pertaining to pharmacy Counting, weighing, measuring, pouring; stocking legend and controlled medications etc. Refill authorization (Accept) Confirming Rx information Organizing/participating in CQI Diagnostic orders (Nuclear) Perform only delegable tasks 64B16-27.420-REGISTERED PHARMACY TECHNICIAN NON-DELEGABLE TASKS Receiving new non written prescriptions: Change in medication name Strength Directions Interpret a prescription or medication order for therapeutic acceptability and appropriateness Prepare a copy of a prescription or read a prescription to any person for purposes p of providing reference concerning treatment of the person or animal for whom the prescription was written; Engage in patient counseling; Engage in any other act that requires the exercise of a pharmacist s professional judgment. 11
ASSESSMENT QUESTION #5 QP is a Pharmacy Manager who is short staffed and has her board approval for 3:1, she takes on becoming a preceptor for 2 college of pharmacy students and a student technician, is this acceptable? a. Yes b. No 64B16-27.430-RESPONSIBILITIES OF THE PHARMACIST Delegation of any duties, tasks or functions to: Pharmacy Interns (students) Registered Pharmacy Technicians Subjective delegation The licensed pharmacist shall retain the professional and personal responsibility for any delegated act 64B16-27.440-POLICIES AND PROCEDURES Any pharmacy utilizing registered pharmacy technicians shall be required to have written policies and procedures regarding the number of positions and their utilization, including the specific scope of responsibilities of technicians, available for inspection by the Florida Board of Pharmacy or its authorized agents and representatives. 12
64B16-30.001 DISCIPLINARY GUIDELINES; RANGE OF PENALTIES; AGGRAVATING AND MITIGATING CIRCUMSTANCES. Violation 1. Chapter 465, F.S.: Penalty range minimum, including first time for single count violations Maximum, including multiple or repeated violations of the same provision ( ) y a. Failure to supervise registered $250 fine and one (1) year $1000 fine and one (1) year pharmacy technician. (Section 465.014, F.S.) probation and 12 hour Laws and Rules course or MPJE. suspension followed by one (1) year probation, to Revocation. c. Operating a pharmacy where $5,000 fine and one (1) year $10,000 fine and one (1) year an unlicensed, unregistered, or probation. suspension followed by one (1) unsupervised person practices year probation, to Revocation. pharmacy. (Section 465.015(1)(b), F.S.) ASSESSMENT QUESTION #6 Registered Pharmacy Technicians are exempt from getting fines or penalties if they commit a violation? a. True b. False DEFINITIONS Registration (RPhT) The recording of professional qualification information relevant to government licensing regulations Certification (CPhT) The process by which h a non-governmental association. or agency grants recognition to an individual specified by that association or agency. Source: 4. Registration definition provided by thefreedictionary.com Source: 5. Certification definition provided by ptcb.org 13
Verify Active Records: www.flhealthsource.com FOLLOWING THE LAW AND RULES Verify Active Records continued: www.flhealthsource.com Person s Name FOLLOWING THE LAW AND RULES Address on file for primary setting DEFINITIONS DELINQUENT - Chapter 456 F.S. - the licensed practitioner who held a CLEAR ACTIVE or CLEAR INACTIVE license, but failed to renew the license by the expiration date. The licensed practitioner is not authorized to practice in the state of Florida. The practitioner is obligated to update his/her profile data. NULL AND VOID - the licensed practitioner failed to renew their licensure status for two renewal cycles, resulting in their license expiring. Practitioner no longer obligated to update his/her profile data. Source: 1. www.flhealthsource.com 14
ASSESSMENT QUESTION #7 The pharmacist is responsible for making sure all staff working is compliant with having current active registration with FL DOH? a. True b. False CONSIDERATIONS FOR WORKFLOW STRATEGIES Time Management Attention To Detail CQI Meetings Error Report Communication Planning Ahead Inventory Aki Asking questions Quizzes Cross Training Continuing Education METHODS TO KEEP UP WITH CE REQUIREMENTS Create spreadsheet of completed CE s Keep a file for all CE s completed Stay ahead of deadlines Make a check off list for CE s remaining to be completed Sign up for CE Broker (Free Edition) Reregister before deadline if possible 15
EXPANDED TECHNICIAN ROLES Medication Reconciliation MTM Pharmacy Techs Quality Analyst Senior/Lead Instructors Pharmacy Buyer Certified SELF-ASSESSMENT QUESTIONS 1. XJ recently graduated from a board approved tech training program, XJ can immediately start working as a tech? True/False 2. Registered Pharmacy Technicians can receive refill authorizations? True/False 3. The pharmacist to tech ratio is 6:1 regardless of the practice setting? True/False 4. Registered Pharmacy Technician should not counsel? True/False 5. Pharmacists are responsible for verifying staff s licensure? True/False Resources FOLLOWING THE LAW AND RULES 1. www.flhealthsource.gov 2. www.leg.state.fl.us 3. www.flrules.org l 4. Registration definition provided by thefreedictionary.com 5. Certification definition provided by ptcb.org 16
QUESTIONS? Let s stay legal! 17