CHAPTER 29 PHARMACY TECHNICIANS

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1 CHAPTER 29 PHARMACY TECHNICIANS 29.1

2 HOSPITAL PHARMACY TECHNICIANS 1. Proper Identification as Pharmacy Technician 2. Policy and procedures regulating duties of technician and scope of responsibility 3. Registration of pharmacy technicians required a. Minimum 17 years old b. Biennial renewal requiring 20 hours CE approved by Board or ACPE c. Board of Pharmacy disciplinary oversight for violation of F.S. 456 and 465 d. Competency effective 1/1/11 Board Approved Training Program 4. Pharmacist must maintain continuing review and supervision Cannot delegate consultation with practitioner regarding interpretation of prescription and data in patient profile Cannot engage in professional consultation with nurse or other health professional Cannot advise the patient One to one ratio of supervision unless otherwise approved 5. Interns No licensed pharmacist may be responsible for the supervision of more than one intern at any one time (64B ) 29.2

3 64B Practice of Pharmacy. Those functions within the definition of the practice of the profession of pharmacy, as defined by Section (13), F.S., are specifically reserved to a pharmacist or a duly registered pharmacy intern in this state acting under the direct and immediate personal supervision of a pharmacist. The following subjects come solely within the purview of the pharmacist. (1) A pharmacist or registered pharmacy intern must: (a) Supervise and be responsible for the controlled substance inventory. (b) Receive verbal prescriptions from a practitioner. (c) Interpret and identify prescription contents. (d) Engage in consultation with a practitioner regarding interpretation of the prescription and date in patient profile. (e) Engage in professional communication with practitioners, nurses or other health professionals. (f) Advise or consult with a patient, both as to the prescription and the patient profile record. (2) When parenteral and bulk solutions of all sizes are prepared, regardless of the route of administration, the pharmacist must: (a) Interpret and identify all incoming orders. (b) Mix all extemporaneous compounding or be physically present and give direction to the registered pharmacy technician for reconstitution, for addition of additives, or for bulk compounding of the parenteral solution. (c) Physically examine, certify to the accuracy of the final preparation, thereby assuming responsibility for the final preparation. (d) Systemize all records and documentation of processing in such a manner that professional responsibility can be easily traced to a pharmacist. (3) Only a pharmacist may make the final check of the completed prescription thereby assuming the complete responsibility for its preparation and accuracy. (4) The pharmacist, as an integral aspect of dispensing, shall be directly and immediately available to the patient or the patient s agent for consultation and shall not dispense to a third party. No prescription shall be deemed to be properly dispensed unless the pharmacist is personally available. (5) The pharmacist performing in this state any of the acts defined as the practice of the profession of pharmacy in Section (13), F.S., shall be actively licensed as a pharmacist in this state, regardless of whether the practice occurs in a permitted location (facility) or other location. (6) The pharmacist may take a meal break, not to exceed 30 minutes in length, during which the pharmacy department of a permittee shall not be considered closed, under the following conditions: (a) The pharmacist shall be considered present and on duty during any such meal break if a sign has been prominently posted in the pharmacy indicating the specific hours of the day during which meal breaks may be taken by the pharmacist and assuring patients that a pharmacist is available on the premises for consultation upon request during a meal break. (b) The pharmacist shall be considered directly and immediately available to patients during such meal breaks if patients to whom medications are delivered during meal breaks are verbally informed that they may request that a pharmacist contact them at the pharmacist s earliest convenience after the meal break, and if a pharmacist is available on the premises during the meal break for consultation regarding emergency matters. Only prescriptions with the final certification by the pharmacist may be delivered. (c) The activities of registered pharmacy technicians during such a meal break shall be considered to be under the direct and immediate personal supervision of a pharmacist if the pharmacist is available on the premises during the meal break to respond to questions by the technicians, and if at the end of the meal break the pharmacist certifies all prescriptions prepared by the registered pharmacy technicians during the meal break. (7) The delegation of any duties, tasks or functions to registered pharmacy interns and registered pharmacy technicians must be performed subject to a continuing review and ultimate supervision of 29.3

4 the pharmacist who instigated the specific task, so that a continuity of supervised activity is present between one pharmacist and one registered pharmacy technician. In every pharmacy, the pharmacist shall retain the professional and personal responsibility for any delegated act performed by registered pharmacy interns and registered pharmacy technicians in the licensee s employ or under the licensee s supervision. Rulemaking Authority , FS. Law Implemented (11)(b), (13), , FS. History New , Amended B Requirements for Pharmacy Technician Registration. Applicants who are at least 17 years of age may apply to become a registered pharmacy technician. (1) All applicants for registration must be made on form DH-MQA PH1183, Pharmacy Technician Registration Application and Instructions effective September 2009, which is incorporated by reference. Contact the Board of Pharmacy at 4052 Bald Cypress Way, Bin #C04, Tallahassee, FL , or (850) to request an application or download the application from the board s website at The application must be accompanied with a non-refundable application fee and an initial registration fee set forth in Rules 64B and 64B , F.A.C. (2) Prior to January 1, 2011, a registered pharmacy technician must submit proof of having met one of the following requirements: (a) Completed a Board approved training course as outlined in Rule 64B , F.A.C; or (b) Worked as a registered pharmacy technician for a minimum of 1500 hours under the supervision of a pharmacist; or (c) Received certification as a pharmacy technician by a certification program accredited by the National Commission for Certifying Agencies. (3) Applicants applying for registration after January 1, 2011 must submit proof of completion of a Board approved training course as outlined in Rule 64B , F.A.C. Rulemaking Authority FS. Law Implemented FS. History New B Registered Pharmacy Technician, to Pharmacist Ratio. (1) Registered pharmacy technicians may assist a pharmacist in performing professional services within a pharmacy environment provided that no pharmacist shall supervise more than one registered pharmacy technician unless otherwise permitted by the Florida Board of Pharmacy. A pharmacist s supervision of a registered pharmacy technician in a working environment requires that a registered pharmacy technician be under the direct personal supervision of a pharmacist. (2) The prescription department manager or consultant pharmacist of record is required to submit a written request and receive approval prior to the pharmacy s allowing a pharmacist to supervise more than one registered pharmacy technician as permitted by law. Such requests shall be reviewed and pre-approved by Board staff according to the guidelines adopted herein, and submitted to the Board for ratification. (3) The request to practice with a ratio greater than 1:1 shall include a brief description of the workflow needs that justify the ratio request. The brief description of workflow needs shall include the operating hours of the pharmacy, number of pharmacists, registered interns, and registered pharmacy technicians employed. (4) A pharmacy that employs pharmacy technicians shall meet the following conditions: (a) Establish written job descriptions, task protocols, and policies and procedures that pertain to duties performed by the registered pharmacy technician and provide this information to the Board upon request; (b) Establish that each registered pharmacy technician is knowledgeable in the established job descriptions, task protocols, and policy and procedures in the pharmacy setting in which the technician is to perform his or her duties; (c) Ensure that the duties assigned to any registered pharmacy technician do not exceed the established 29.4

5 job descriptions, task protocols, and policy and procedures, nor involve any of the prohibited tasks in Rule 64B , F.A.C.; or (d) Ensure that each registered pharmacy technician receives employer-based or on-the-job training in order for the registered pharmacy technician to assume his or her responsibilities and maintain documentation of the training. (5) The pharmacy shall maintain a policy and procedure manual with regard to registered pharmacy technicians which shall include the following: (a) Supervision by a pharmacist; (b) Minimum qualifications as established by law; (c) Documentation of in-service education and/or on-going training and demonstration of competency, specific to practice site and job function; (d) General duties and responsibilities of registered pharmacy technicians; (e) Retrieval of prescription files, patient files, patient profile information and other records pertaining to the practice of pharmacy; (f) All functions related to prescription processing; (g) All functions related to prescription legend drug and controlled substance ordering and inventory control, including procedures for documentation and recordkeeping; (h) rescription refill and renewal authorization; (i) Registered pharmacy technician functions related to automated pharmacy systems; and (j) Continuous quality improvement program. Rulemaking Authority FS. Law Implemented , (1)(b) FS. History New , Amended , Formerly 21S-4.02, Amended , Formerly 21S-4.002, Amended , Formerly 21S , 61F , Amended , Formerly 59X , Amended , , B Registered Pharmacy Technician Responsibilities. (1) Registered pharmacy technicians may assist the pharmacist in performing the following tasks: (a) Retrieval of prescription files, patient files and profiles and other such records pertaining to the practice of pharmacy; (b) Data Entry; (c) Label preparation; (d) The counting, weighing, measuring, pouring and compounding of prescription medication or stock legend drugs and controlled substances, including the filling of an automated medication system; (e) Initiate communication to a prescribing practitioner or their medical staffs (or agents) regarding patient prescription refill authorization requests. For the purposes of this section prescription refill means the dispensing of medications pursuant to a prescriber s authorization provided on the original prescription; (f) Initiate communication to confirm the patient s name, medication, strength, quantity, directions and date of last refill; (g) Initiate communication to a prescribing practitioner or their medical staff (or agents) to obtain clarification on missing or illegible dates, prescriber name, brand/generic preference, quantity, DEA registration number or license numbers; and (h) May accept authorization for a prescription renewal. For the purposes of this section, prescription renewal means the dispensing of medications pursuant to a practitioner s authorization to fill an existing prescription that has no refill remaining. (2) Registered Pharmacy technicians shall not: (a) Receive new verbal prescriptions or any change in the medication, strength or directions; (b) Interpret a prescription or medication order for therapeutic acceptability and appropriateness; 29.5

6 (c) Conduct a final verification of dosage and directions; (d) Engage in prospective drug review; (e) Provide patient counseling; (f) Monitor prescription usage; and (g) Override clinical alerts without first notifying the pharmacist. (3) Nuclear pharmacy permits allow the registered pharmacy technician to receive diagnostic orders only. The pharmacist must receive therapy or blood product procedure orders. (4)(a) All registered pharmacy technicians shall identify themselves as registered pharmacy technicians by wearing a type of identification badge that is clearly visible which specifically identifies the employee by name and by status as a registered pharmacy technician ; and (b) All registered pharmacy technicians shall state their names and verbally identify themselves as registered pharmacy technicians in the context of telephone or other forms of communication. Rulemaking Authority , FS. Law Implemented FS. History New , Formerly 21S , Amended , Formerly 21S , 61F , 59X , Amended , B Responsibilities of the Pharmacist. The delegation of any duties, tasks or functions to registered pharmacy interns and registered pharmacy technicians must be performed subject to a continuing review and ultimate supervision of the pharmacist who instigated the specific task, so that a continuity of supervised activity is present between one (1) pharmacist and one (1) registered pharmacy technician. In every pharmacy, the licensed pharmacist shall retain the professional and personal responsibility for any delegated act performed by registered pharmacy interns and registered pharmacy technicians in his employ and under his supervision. Rulemaking Authority FS. Law Implemented FS. History New , Formerly 21S-4.03, Amended , Formerly 21S-4.003, 21S , 61F , 59X , Amended B 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. Rulemaking Authority FS. Law Implemented FS. History New , Formerly 21S-4.04, 21S , Amended , Formerly 21S , 61F , 59X , Amended B Standards for Approval of Registered Pharmacy Technician Training Programs. (1) The following programs are approved Registered Pharmacy Technician Training programs: (a) Pharmacy technician training programs accredited, approved or licensed on or before January 1, 2011 by the American Society of Health-System Pharmacists, (b) Pharmacy technician training programs accredited, approved or licensed on or before January 1, 2011 by the Southern Association of Colleges and Schools, (c) Pharmacy technician training programs accredited, approved or licensed on or before January 1, 2011 by the Florida Department of Education, or Florida Commission for Independent Education, (d) Pharmacy technician training programs provided by a branch of the federal armed services for which the applicant possesses a certificate of completion. (e) Pharmacy technician training programs accredited, approved or licensed on or before January 1, 2011 by the Council on Occupational Education. (2) All other training programs must be employer based. Any pharmacy technician training program sponsored by a Florida permitted pharmacy or affiliated group of pharmacies under common ownership, 29.6

7 must contain a minimum of 160 hours of training, that extends over a period not to exceed 6 months; is provided solely to employees of said pharmacy or affiliated group; and has been approved by the Board. An application for approval of a Registered Pharmacy Technician Training Program shall be made on Board of Pharmacy approved form DH-MQA 1232 Board of Pharmacy Registered Pharmacy Technician Training Program Provider Application, effective February 2010, which is hereby incorporated by reference. To obtain an application, contact the Board of Pharmacy at 4052 Bald Cypress Way, Bin #C04, Tallahassee, FL , or (850) , or download the application form the board s website at http//: The application must be accompanied with a non-refundable application fee. The following objectives must be met: (a) Program content: 1. Introduction to pharmacy and health care systems: a. Confidentiality, b. Patient rights and Health Insurance Portability and Accountability Act (HIPAA). 2. Pharmacy law: a. Federal law, b. State law, c. State rules, d. Pharmacy technician rules and law. 3. Pharmaceutical-medical terminology, abbreviations, and symbols: a. Medication safety and error prevention, b. Prescriptions and medication orders. 4. Records management and inventory control: a. Pharmaceutical supplies, b. Medication labeling, c. Medication packaging and storage, d. Controlled substances, e. Adjudication and billing. 5. Interpersonal relations, communications, and ethics: a. Diversity of communications, b. Empathetic communications, c. Ethics governing pharmacy practice, d. Patient and caregiver communication. 6. Pharmaceutical calculations. (b) Materials and Methods. Evidence satisfactory to the Board shall be presented that: 1. Learning experiences and teaching methods are appropriate to meet the content stated above. 2. Time allotted for each activity shall be sufficient for the participant to meet the objectives. 3. Principles of adult education are utilized in determining teaching strategies and learning activities. (c) Faculty Qualifications. 1. The faculty shall provide evidence of academic preparation or experience in the subject matter. 2. When the subject matter of an offering includes pharmacy technician practice, a licensed pharmacist or registered pharmacy technician with expertise in the content area must be involved in the planning and instruction. 3. Pharmacy technician faculty supervising learning experiences in a clinical area in this State shall be currently registered. 4. When an offering includes clinical practice training in Florida, a Florida licensed pharmacist competent in the practice area shall provide supervision. (d) Evaluation. Evidence satisfactory to the Board shall be presented that participants are given an opportunity to evaluate learning experiences, instructional methods, facilities and resources used for the offering. Self-directed learning experiences, including but not limited to home study, computer programs, 29.7

8 internet or web-based courses, are required to evaluate participant knowledge at the completion of the learning experience. The evaluation must include a minimum of 100 questions. The participant must achieve a minimum score of 70% on the evaluation to receive the certificate of completion. The evaluation must be graded by the provider. (e) There shall be a designated person assuming responsibility for registered pharmacy technician training program. If the contact person is not a licensed pharmacist or registered pharmacy technician, provision should be made for insuring licensed pharmacist or registered pharmacy technician input in overall program planning and evaluation. (f) Required documentation. 1. Providers shall establish written policies and procedures for implementation of the registered pharmacy technician training program. 2. Providers shall maintain a system of record-keeping which provides for storage of program information. 3. Records of programs shall be maintained for three years and be available for inspection by the board or department. 4. Providers shall furnish each participant with an authenticated individual Certificate of Completion. 5. Providers shall securely maintain all participant records and copies of certificates issued for a period of three years and said records shall be available for inspection by the board or department. Rulemaking Authority FS. Law Implemented FS. History New B Pharmacy Intern Registration Internship Requirements (U.S. Pharmacy Students/Graduates). A U.S. pharmacy student or graduate is required to be registered with the Department of Health as an intern before being employed as an intern in a pharmacy in Florida. (1) All applications for registration must be made on form DH-MQA 104, Pharmacy Intern Application for U.S. Pharmacy Students/Graduates and Instructions, (Rev. 09/09), which is hereby incorporated by reference. Contact the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida , or (850) to request an application or download the application from the board s website at (2) An applicant for pharmacy intern registration must submit proof of: (a) Enrollment in an intern program at a college or school of pharmacy accredited by the Accreditation Council of Pharmaceutical Education (ACPE); or (b) Graduation from a college or school of pharmacy accredited by the ACPE. (3) Upon the receipt of proof satisfactory to the Board that the intern applicant meets the requirement of either paragraph (2)(a) or (2)(b), unless there exists good cause for the Board s refusal to certify an applicant as set forth in Section , F.S., the Board shall certify the applicant to the Department for registration as an intern. (4) No intern shall perform any acts relating to the filing, compounding, or dispensing of medicinal drugs unless it is done under the direct and immediate personal supervision of a person actively licensed to practice pharmacy in this state. (5) All internship experience for the purpose of qualifying for the examination pursuant to Section (1)(c), F.S., shall be obtained in a community pharmacy, institutional pharmacy or any Florida Board of Pharmacy approved pharmacy practice, which includes significant aspects of the practice of pharmacy as defined in Section (13), F.S. (6) An internship program at college or school of pharmacy accredited by the ACPE shall assure that community or institutional pharmacies utilized for the obtaining of internship experience meet the following minimum requirements: 29.8

9 (a) The pharmacy shall hold a current license or permit issued by the state in which they are operating and shall have available all necessary equipment for professional services, necessary reference works, in addition to the official standards and current professional journals. (b) The pharmacy shall be operated at all times under the supervision of a pharmacist and shall be willing to train persons desiring to obtain professional experience. (c) The pharmacy shall establish to the program s satisfaction that the pharmacy fills, compounds and dispenses a sufficient number, kind and variety of prescriptions during the course of a year so as to afford to an intern a broad experience in the filling, compounding and dispensing of prescription drugs. (d) The pharmacy shall have a clear record as to observance of federal, state and municipal laws and ordinances covering any phase of activity in which it is engaged. (e) No pharmacist may be responsible for the supervision of more than one intern at any one time. (7) The program shall assure that all preceptors meet the following requirements: (a) The pharmacist shall willingly accept the responsibility for professional guidance and training of the intern and be able to devote time to preceptor training sessions and to instruction of the intern. (b) The pharmacist shall hold current licensure in the state in which pharmacy is practiced. (c) The pharmacist shall be ineligible to serve as a preceptor during any period in which the pharmacist s license to practice pharmacy is revoked, suspended, on probation, or subject to payment of an unpaid fine levied by lawful Board order, or during any period in which the pharmacist s license is the subject of ongoing disciplinary proceedings. (d) The pharmacist shall agree to assist the school or college of pharmacy in the achievement of the educational objectives set forth and to provide a professional environment for the training of the intern. (e) Evidence shall be provided of the pharmacist s desire to continue broadening professional education and of an active involvement in a patient-oriented practice. (8) In the event a program meets all the requirements set forth in subsection (2) of this rule, except for prior approval by the Florida Board of Pharmacy, any applicant submitting it for the purpose of qualifying for licensure by examination must show in addition to successful completion of the internship: (a) Approval of the program by a state board of pharmacy; and (b) Sufficient hours to total 2080 hours; or (c) Licensure in another state and work performed as a pharmacist for a sufficient number of hours to total 2080 hours when combined with the internship hours. (9) All internship hours may be obtained prior to the applicant s graduation. (10) Proof of completion of an internship program shall consist of a certification that the applicant has completed the program. If additional hours are required to total 2080 hours, satisfactory proof of the additional hours shall be constituted by the program s certification of completion of the additional hours. (11) Hours worked in excess of 50 hours per week prior to the applicant s graduation or in excess of 60 hours per week after an applicant s graduation, will not be credited toward meeting the required internship hours. (12) The Board approves all internships that are required to obtain the doctor of pharmacy degree from institutions which are accredited as provided by Section (1)(b)1., F.S. Applicants graduating after January 1, 2001 with the doctor of pharmacy degree from such institutions shall be deemed to have met the requirements of this section with documentation of graduation. (13) The Board may conduct periodic review of programs to assure compliance with these rules. (14) Proof of current licensure in another state and work as a pharmacist for up to 2080 hours may substitute for all or part of the internship requirement. (15) Governmental and private radiopharmacy internship programs shall not apply to the pharmacy internship required under subsection (1) of this rule. Rulemaking Authority FS. Law Implemented (12), , , FS. History New , Amended

10 64B Pharmacy Interns; Registration; Employment. (1) A pharmacy intern is required to be registered with the Department of Health as an intern before being employed as an intern in a pharmacy in Florida. (2) An applicant for pharmacy intern registration must submit proof of: (a) Enrollment in an intern program at an accredited college or school of pharmacy or; (b) Graduation from an accredited college or school of pharmacy and not yet licensed in the state. For purposes of this rule only, any individual who has been accepted by the Foreign Pharmacy Graduate Examination Commission to sit or the Foreign Pharmacy Graduate Equivalency Examination shall be considered a graduate of an accredited college or school of pharmacy. The internship experience allowed under this provision shall not count toward the 500-hours internship required subsequent to passage of the Foreign Pharmacy Graduate Equivalency Examination as mandated in Section (1)(b)2., F.S., and as defined in Rule 64B , F.A.C. (3) Upon the receipt of proof satisfactory to the Board that the intern applicant meets the requirements of either paragraph (a) or (b) of subsection (2), and unless there exists good cause for the Board s refusal to certify an applicant as set forth in Section , F.S., the Board shall certify the applicant to the Department for registration as an intern. (4) No intern shall perform any acts relating to the filling, compounding, or dispensing of medicinal drugs unless it is done under the direct and immediate personal supervision of a person actively licensed to practice pharmacy in this state. Specific Authority FS. Law Implemented FS. History Amended , , , Repromulgated , Amended , , Formerly 21S-1.21, Amended , Formerly 21S-1.021, Amended , , Formerly 21S , 61F , 59X , Amended

11 Pharmacy Technicians in a Nursing Home Pharmacy NURSING HOME 1. Policy and Procedures must define: a. What the technician will do in the Pharmacy. b. How they will do the functions identified. c. What they may not do in the Pharmacy. 2. Activities allowed a. Entry of information into the computer, unit dose, facility re-supply, return of medications 3. Activities not allowed a. May not engage in professional communication with licensed practitioners 4. Ratio/supervision - suggest getting 3:1 ratio approved even if you may not need this many techs at the present time 5. Name badges -- worn clearly visible and identified as a technician or nurse consultant 29.11

12 NOTE: rule 64B governs the practice of pharmacy with regard to the use of pharmacy technicians. This rule lists certain functions to be personally performed by a pharmacist, or a duly registered intern acting under the direct and immediate personal supervision of a licensed pharmacist. This list of pharmacist functions is not meant to be conclusive and all encompassing, but may be used to help define functions that may not be delegated to a pharmacy technician. Noteworthy from the list of functions that may not be delegated by the pharmacist are: 1. Engage in consultation with a practitioner regarding interpretation of the prescription and data in a patient profile; 2. Engage in professional communication with licensed practitioners, nurses or other health professions, and 3. Advise or consult with a patient, both as to the prescription and the patient profile record. From the above, it is clear that a pharmacy technician should not make the telephone call to a practitioner s office to request additional refills for a patient. Also if the patient should be consulted concerning his/her prescription it should be a direct pharmacistpatient exchange and not relayed via the pharmacy technician. Other points from this section include: No licensed pharmacist shall supervise more than one pharmacy technician unless otherwise permitted by the Florida Board of Pharmacy; All pharmacy technicians shall wear a type of identification badge that is clearly visible which specifically identifies the employee by stating pharmacy technician ; Any pharmacy utilizing 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. These are a few of the issues addressed in the rule. It is suggested a pharmacist utilizing pharmacy technicians completely review Rule 64B ; , , and copies of which are at the end of this chapter

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