Utah State Regulatory Update April 2019
Senate Bill (SB) 184. passed during the 2018 Utah Legislative General Session, amended the Pharmacy Practice Act to permit a pharmacist to dispense a self-administered hormonal contraceptive under a standing prescription order.
Section R156-17b-102. The following definitions are added:
The term "self-administered hormonal contraceptive" is defined by referring to Section 26-62-102(9).
The new "Utah Hormonal Contraceptive Self Screening Risk Assessment Questionnaire" is defined as the self-screening risk assessment questionnaire that is approved by the Division of Occupational and Professional Licensing pursuant to Section 26-62-106.
Section R156-17b-309. These proposed amendments make the following clarifications and updates to CE requirements by:
- for pharmacists, updating CE standards and topics by deleting the old topics of "drug therapy or patient management," and substituting the current topics of "disease state management/drug therapy," "AIDS/ HIV therapy," or "patient safety";
- for pharmacy technicians, reducing the eight-hour "live or technology-enabled participation" requirement to six hours;
- for pharmacists, clarifying the existing CE requirements regarding individual licensee practices (such as requiring two CE hours in topics related to long acting injectables if the licensee will be providing administration of long-acting injectable drug therapy, and requiring two hours in topics related to hormonal contraceptive therapy if the licensee will be prescribing and dispensing a self-administered hormonal contraceptive);
- adding additional options for fulfilling CE requirements, including allowing one "live" CE hour for attending one Board meeting, for a maximum of two CE hours during each two-year period, and allowing two CE hours for each hour of lecturing or instructing a CE course or teaching in the licensee's profession, for a maximum of ten CE hours during each two-year period; and
- requiring licensees to prove compliance with their CE requirements through registration with the CPE Monitor service, accessible through the National Association of Boards of Pharmacy website. Either of the two CPE Monitor plans, the standard or the plus, meet this requirement. Licensees using the free CPE Monitor standard plan are also required to maintain a certificate of completion or other adequate documentation for CE that cannot be tracked through this plan.
Section R156-17b-610. These proposed amendments provide guidelines for patient counseling by a pharmacist or pharmacy intern who dispenses a self-administered hormonal contraceptive. The guidelines require the pharmacist or pharmacy intern to obtain a completed Utah Hormonal Contraceptive Self-Screening Risk Assessment Questionnaire, and provide the written information and counseling described in Section 26-62-106.
Section R156-17b-621b. This proposed rule establishes the operating standards for pharmacists and pharmacy interns dispensing a self-administered hormonal contraceptive. These standards require special initial training, CE, and the use of the new Utah Hormonal Contraceptive Self-Screening Risk Assessment Questionnaire, which was adopted by the Division of Occupational and Professional Licensing in collaboration with the Board.
Pharmacy Technician Training Programs. "On-the-job" pharmacy technician training pharmacies will no longer meet the education requirement for pharmacy technician trainee applications submitted after December 31, 2018. Pharmacy technician trainees must attend a program that is American Society of Health-System Pharmacists (ASHP)-accredited; in ASHP candidate status; or conducted by the National Pharmacy Technician Association, Pharmacy Technicians University, or a branch of the United States Armed Forces. Please refer to the following excerpt of the rule for further clarification. R156-17b-303a.
Qualifications for Licensure.
Education Requirements. (3) In accordance with Subsection 58-17b-305(1)(f), a pharmacy technician shall complete a training program that is: accredited by ASHP; or conducted by the National Pharmacy Technician Association; Pharmacy Technicians University; or a branch of the Armed Forces of the United States, and meets the following standards:
- Completion of at least 180 hours of directly supervised practical training in a licensed pharmacy as determined appropriate by a licensed pharmacist in good standing; and
- Written protocols and guidelines for the teaching pharmacist outlining the utilization and supervision of pharmacy technician trainees that address: (A) the specific way supervision will be completed; and (B) an evaluative procedure to verify the accuracy and completeness of all acts, tasks and functions performed by the pharmacy technician trainee. An individual shall complete a pharmacy technician training program and successfully pass the required examination within two years after obtaining a pharmacy technician trainee license. Unless otherwise approved, an individual who fails to apply for and obtain a pharmacy technician license within the two-year time frame shall repeat a pharmacy technician training program in its entirety if the individual pursues licensure as a pharmacy technician.
- Pharmacy technician training programs that received Division approval on or before April 30, 2014 are exempt from satisfying standards for students enrolled on or before December 31, 2018. A student in such program shall comply with the program completion deadline and testing requirements, except that the license application shall be submitted to the Division no later than December 31, 2021. A program in ASHP candidate status shall notify a student prior to enrollment that if the program is denied accreditation status while the student is enrolled in the program, the student will be required to complete education in another program with no assurance of how many credits will transfer to the new program. A program in ASHP candidate status that is denied accreditation shall immediately notify the Division, enrolled students and student practice sites, of the denial. The notice shall instruct each student and practice site that: (i) the program no longer satisfies the pharmacy technician license education requirement in Utah; and (ii) enrollment in a different program meeting requirement established is necessary for the student to complete training and to satisfy the pharmacy technician license education requirement in Utah. An applicant from another jurisdiction seeking licensure as a pharmacy technician in Utah is deemed to have met the qualifications for licensure if the applicant: (a) has engaged in the practice of a pharmacy technician for a minimum of 1,000 hours in that jurisdiction within the past two years or has equivalent experience as approved by the Division in collaboration with the Board; and (b) has passed and maintained current PTCB or ExCPT certification.
What does this mean for pharmacists practicing in the state of Utah?
- Pharmacists are now allowed limited prescriptive authority of hormonal contraception by protocol, if they meet all requirements for training, assessment, and monitoring as part of their program and protocol.
- Pharmacists must be aware of all changes to CE requirements and tracking for all renewals going forward. Proper documentation and completion of CE is required for continued practice within the state.
- There have been some major changes regarding technician training programs, and what is accepted within the state. Review your pharmacy's technician training program and requirement and ensure that it either satisfied all requirements for the state or provide a suitable alternative for your technicians going forward. Educate your technician candidates on the changes to the state's requirements.
Utah State Regulatory Summary- 2018
The following laws, summarized here, were enacted by the Utah legislature during the 2018 session:
58-17b-622. Pharmacy benefit management services - Auditing of pharmacy records - Appeals. Effective May 8, 2018.
If an audit is conducted on site at a pharmacy, the entity conducting the audit:
- shall give the pharmacy 10 days advanced written notice of the audit; and the range of prescription numbers or a date range included in the audit;
- may not audit a pharmacy during the first five business days of the month, unless the pharmacy agrees to the timing of the audit.
58-37-7. Labeling and packaging-controlled substance -- Informational pamphlet for opiates Effective May 8, 2018.
A pharmacist shall affix a warning to the container or the lid for the container in which the substance is sold or dispensed that contains the following text:
- "Caution: Opioid. Risk of overdose and addiction"; or
- any other language that is approved by the Department of Health.
A pharmacist shall prominently display the informational pamphlet developed by the Department of Health and use this pamphlet as part of their patient counseling session.
Chapter 37f- Controlled Substance Database Act Updates Effective May 8, 2018
- If the dispenser's access and review of the database suggest that the individual seeking an opioid may be obtaining opioids in quantities or frequencies inconsistent with generally recognized standards, the dispenser shall reasonably attempt to contact the prescriber to obtain the prescriber's informed, current, and professional decision regarding whether the prescribed opioid is medically justified.
- Failure by pharmacist to submit information Penalties added
- A pharmacist must submit information to the PMP real time, or 24-hour daily or next business day, whichever is later, batch submission of the information.
What do these new regulations mean for pharmacists practicing within the state of Utah?
- The new law now places limits and guidelines on when and how a PBM can initiate an audit, allowing pharmacists to comply with those audits with minimal disruption of patient care, and ensure that the pharmacist in charge is aware of these new audit policies.
- When a pharmacist dispenses a prescription for an opioid, they must ensure that all required information, including a new addiction warning label is affixed to the vial.
- The pharmacist must make available an educational brochure approved by the Department of Health; they should also use this for counseling on the new opioid medication
- Ensure that both steps are included in any standard operating procedures and that all pharmacists are aware and trained on these new required actions.
- The controlled substance reporting regulation has been updated to include penalties for not using the state reporting site, new requirements for when a dispensing must be recorded into the site and outlining the state's plan to monitor usage of the site by both practitioners and pharmacists. Finally, language was updated to exempt veterinarian activities from reporting requirements, as well as ensure that all pharmacists are registered to access and are using the reporting site as part of their standard dispensing duties.
For full regulatory language, refer to the Utah Board of Pharmacy.
