Kansas State Regulatory Update April 2019
Pharmacy Technician Certification
Before the October 2019 renewal period for pharmacy technicians, each pharmacy technician initially registered on or after July 1, 2017, whose registration expires on October 31, 2019, will be required to pass a national pharmacy technician certification examination (K.A.R. 68-5-17). The Board has approved the Pharmacy Technician Certification Board and the National Healthcareer Association's Examination for the Certification of Pharmacy Technicians, also known as ExCPT. Any technician who is unable to take or pass an approved exam may request a six-month extension at least 30 days before the pharmacy technician's registration expiration date.
New Board Regulations and Guidance - Effective January 4, 2019.
Kansas Administrative Regulations (K.A.R.) 68-7-10, 68-9-2, and 68-9-3 align definitions with statutory changes and allow nurses and other healing arts professionals to access automated drug delivery systems in long-term care facilities, pharmacies, and other facilities to administer medications to patients consistent with their respective practice acts. This should eliminate the perceived need for nurses to also be registered as pharmacy technicians.
K.A.R. 68-2-23 requires each owner of a Kansas-registered pharmacy to notify the Board within 30 days of any denial, limitation, suspension, revocation, voluntary surrender, or other disciplinary action taken by the state of Kansas or another jurisdiction against the pharmacy, the pharmacy owner, or any application, license, registration, or permit held by the pharmacy owner.
K.A.R. 68-20-15b requires either the PIC or the pharmacy owner to notify the Board in writing within one day of any suspected diversion, theft, or loss of any controlled substance (CS) and provide a copy of Drug Enforcement Administration (DEA) Form 106 upon completion.
K.A.R. 68-7-25 requires each pharmacist, pharmacy technician, and pharmacy student to notify the Board within 30 days of any criminal arrest, charge, or conviction rationally related to drugs or the practice of pharmacy, or any denial, limitation, suspension, revocation, voluntary surrender, or other disciplinary action taken by the state of Kansas or another jurisdiction against any professional or occupational application, license, registration, or permit held by the individual.
Intern Immunization Authority
The Board recently adopted guidance to provide clarification regarding whether pharmacy students or interns who administer vaccines are required to have a signed vaccination protocol with licensed physicians. Interns are authorized to administer vaccines under Kansas Statutes Annotated 65-1635a only under the direct supervision and control of a pharmacist. Each intern is required to complete a CPR course and an immunization training course approved by Accreditation Council for Pharmacy Education (ACPE) or the Board and have a current CPR certificate. The supervising pharmacist is also required to complete a CPR course and an immunization training course approved by ACPE or the Board and have a current CPR certificate. The supervising pharmacist is responsible for ensuring that he or she has a current, signed protocol with a licensed physician to administer vaccinations and that all requirements are met for administering, recording, and reporting all vaccinations administered by the intern under the pharmacist's supervision in accordance with the Kansas Pharmacy Act. Interns are not required to have a signed protocol or be party to a protocol between their supervising pharmacist and a licensed physician.
What does this mean for pharmacists practicing in the state of Kansas?
- All pharmacy managers must ensure that their technician staff is aware of the changes for technician licensure, and that two exams are approved for national certification. All technicians on staff must adhere to the registration policies outlined above for continued employment. All hiring practices for pharmacy technicians must include a validation of state registration and adherence to these new requirements.
- Several administrative changes involve reporting, recordkeeping for the Board of Pharmacy for the pharmacy and pharmacist permit holder. Ensure that all processes include these new notifications and that all staff are trained.
- Pharmacists can allow interns to administer immunizations if both the pharmacist and intern meet the above requirements. Review all current intern and immunizing pharmacist credentials to ensure that the requirements are met in your pharmacy. All hiring processes must include a method of reviewing candidate credentials prior to immunizing.
Kansas State Regulatory Summary- 2018
The following regulations were enacted or amended during the 2018 legislative session and can be found in detail at the Kansas Board of Pharmacy.
KAR 68-13-2: Definitions update; Compounding
KAR 68 13-3: Compounding of Non-Sterile Products
KAR 68-13-4: Compounding of Sterile Products
KAR 68-21-7: Drugs of Concern
KAR 68-5-17: Pharmacy Technicians; Certification Exams; Request for Extension
What do these new regulations mean for pharmacists practicing within the state of Kansas?
- Term definitions have been updated to reflect updated FDA and USP compounding requirements and language. If you work in a pharmacy location that participates in non-sterile or sterile compounding, review all terms to ensure that new regulations are understood.
- Additional guidance for non-sterile compounding is present in the regulations to include what can be compounded, compounding, storage, and labeling conditions, and record-keeping. Review and audit that all aspects of the law is being met in your current practice of non-sterile compounding.
- Additional guidance has also been included for sterile compounding (as in above), but also including quality and sterility testing, appropriate device inspection and certification, and employee technique testing. Ensure that there is a complete understanding of all regulations and that proper technique assessment is completed and proper documentation and record-keeping is in place.
- Provide consistent educational opportunities to maintain professional competency in current techniques and processes.
- Gabapentin has been added as a "drug of concern" based on increased incidences of abuse. Execute due diligence and professional judgement when dispensing this medication to patients.
- Pharmacy technicians must pass either the PTCE or ExCPT exam before their first renewal date. If the candidate fails to pass either exam, they may file for an extension to the Board of Pharmacy 30 days prior to their registration expiration.
- All technicians must provide proof to the Board of Pharmacy within 30 days of passing, or prior to their first renewal date, whichever is less. Communicate these changes to your technician employees and ensure that they are prepared for their national exam through proper training and education.
For full regulatory language, refer to the Kansas Board of Pharmacy
