Section 657.40.3. General requirements.

To participate in a TCT program, a hospital pharmacy shall be located in Iowa and provide pharmaceutical services to patients receiving treatment in a hospital located in Iowa. To participate in a TCT program, a general pharmacy shall be located in Iowa, and a TCT program shall only be implemented to provide pharmaceutical services to patients in a long-term care facility located in Iowa.

       40.3(1) Site-specific. A TCT program shall be specific to the site at which implementation of the program is proposed and shall include a site-specific training program tailored to the patient population and the drug distribution system utilized.

       40.3(2) Plan approval. At least 90 days prior to anticipated implementation of a TCT program, the pharmacist in charge shall submit the program plan, consistent with the requirements of these rules, for board approval. A pharmacy shall not implement a TCT program prior to receipt of notification that the board has approved the submitted TCT program plan.

       40.3(3) Technician utilization plan. The pharmacy technician utilization plan shall specifically identify the individual certified pharmacy technicians authorized to participate in the TCT program and shall identify in detail the types of work that the certified pharmacy technicians may perform and check. The pharmacy shall include participation in the TCT program in the defined duties of any certified pharmacy technician authorized to participate in the TCT program, and if the certified pharmacy technician is authorized to check the work of other certified pharmacy technicians, that function shall be clearly identified in the checking technician’s duties.

       40.3(4) Certified pharmacy technician participation. All of the following shall apply to a certified pharmacy technician authorized to participate in a TCT program.

        a.           National certification. The certified pharmacy technician’s national certification shall be current and in good standing.

        b.           Iowa registration. The certified pharmacy technician’s registration with the board shall be current, in good standing, and not currently subject to disciplinary charges or sanctions.

        c.           Prior experience. The checking technician shall be working at the pharmacy full- or part-time and shall have met the experience requirement for a checking technician as specified in policies and procedures and in the TCT program plan.

        d.           Training. The certified pharmacy technician shall complete site-specific training in the TCT program and the functions to be performed by the certified pharmacy technician as part of the TCT program.

        e.           Specialized training for checking technician. A certified pharmacy technician who is a checking technician shall receive specialized and advanced training as provided in policies and procedures, including training in the prevention, identification, and classification of medication errors. The training program for a checking technician shall be didactic in nature and shall include successful completion of a competency test.

       40.3(5) Responsible individuals. The pharmacist in charge may designate one pharmacist to be responsible for meeting TCT program training and validation requirements and may designate one or more pharmacists to supervise the activities of certified pharmacy technicians authorized to participate in the TCT program. A pharmacist supervising TCT program activities shall provide program plan evaluation information to the responsible pharmacist or the pharmacist in charge for collection and analysis. Each individual involved in the TCT program shall be responsible for the activities performed by that individual and for ensuring that those activities adhere to the TCT program policies and procedures and comply with board rules. The pharmacist in charge shall be ultimately responsible for TCT program activities and for development and implementation of TCT program policies and procedures.

       40.3(6) Policies and procedures. Parameters for supervising the activities of certified pharmacy technicians participating in the TCT program, including but not limited to specialized and advanced training for checking technicians, shall be specified in policies and procedures regarding the utilization of pharmacy technicians. Policies and procedures shall provide for continuous evaluation of certified pharmacy technicians authorized to participate in the TCT program, shall identify benchmarks and sentinel events, shall define an excessive overall error rate, shall address certified pharmacy technician retraining procedures, and shall address pharmacy staffing.

       40.3(7) Staffing. Pharmacy staffing shall be adequate to ensure consistent and safe implementation of the TCT program and to optimize pharmacist patient care services.

       40.3(8) Pharmacist review. Except in an emergency, when the pharmacy is closed, or when the prescriber is directly supervising and overseeing the administration of the drug to the patient, a pharmacist shall review all orders against a medication profile as required by rule 657—8.21(155A). A pharmacist shall be on site and available to certified pharmacy technicians during any period that TCT functions are being performed.

       40.3(9) Additional drug check prior to administration. The drug distribution system shall be structured so that at least one additional check of dispensed drugs, following dispensing and checking by a checking technician, is completed by a licensed health care professional in the facility prior to administration of the drug to the patient. A licensed health care professional or certified medication aide shall administer the drug to the patient. The TCT program plan shall identify the individuals authorized to administer the drug to the patient. The identification of these individuals may consist of a description of the classification of the authorized individuals, such as “registered nurse,” “licensed practical nurse,” or “certified medication aide,” or the identification may specifically identify the authorized individuals by name and title. Alternatively, the identification may reference an existing facility policy or procedure that identifies or specifies the individuals authorized to administer a drug to a patient.

       40.3(10) Program evaluation. Implementation of a TCT program shall result in the redirection of the pharmacist from distributive tasks to cognitive and patient care activities. As part of an ongoing program review and evaluation as provided in subrule 40.4(5), the pharmacist in charge or designee shall document the specific cognitive and patient care activities, and a summary of the approximate amount of time pharmacists spend on those activities, as a result of implementation of the TCT program. Program review and evaluation records shall be available for inspection and copying by the board or its representatives and any other authorized agencies for two years following the date of the record.

[ARC 9783B, IAB 10/5/11, effective 11/9/11]