Title 201 | Chapter 002 | Regulation 480REG
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BOARDS AND COMMISSIONS
Board of Pharmacy
(Amended at ARRS Committee)
201 KAR 2:480.Telework and electronic supervision for remote prescription processing.
Section 1.
Definitions.(1)
"Electronic Supervision" means(2)
"Telework" means the practice or assistance in the practice of pharmacy by a contractor or an employee of the pharmacy from a remote location outside of the permitted pharmacy.(3)
"Telework Functions" means:(a)
For1.(a)
Receiving, interpreting, or clarifying medical orders or prescription drug orders;2.(b)
Order entry and order entry verification;3.(c)
Transfer of prescription information;4.(d)
Prospective drug utilization reviews;5.(e)
Interpretation of clinical data;6.(f)
Refill authorizations;7.(g)
Performing therapeutic intervention; and8.(h)
Patient counseling; and(b)(4)
For(4)(5)
"Telework Site" means a location within the United States where a pharmacy technician assistsSection 2.
Registration. The pharmacy and the pharmacist-in-charge of the pharmacy shall ensureSection 3.
Requirements.(1)
The pharmacy and pharmacist-in-charge, or the designee appointed by the pharmacist in charge shall ensure that interns and pharmacy technicians working under electronic supervision are supervised by a Kentucky licensed pharmacist.(2)
A pharmacist or intern that engages in the practice of pharmacy and a pharmacy technician that assists in the practice of pharmacy at a telework site shall be licensed or registered by the board and shall comply with all applicable federal and state law(3)
Prescription drugs and related devices shall not be at a telework site.(4)
The pharmacy utilizing telework functions shall:(a)
Possess a written agreement with the licensee or registrant that includes all conditions, duties, and policies governing the licensee or registrant engaged in telework activities;(b)
Maintain a continuously updated, readily retrievable, list of all licensees and registrants engaged in telework and the:1.
Address and phone number for each telework site;2.
Functions being performed by licensees or registrants engaged in telework; and3.
The name of the pharmacist providing supervision for each non-pharmacist registrant.(5)
The pharmacist-in-charge or the designee appointed by the pharmacist in charge of a pharmacy utilizing telework functions shall:(a)
Develop, implement, and enforce a continuous quality improvement program designed to objectively and systematically:1.
Monitor, evaluate, and document the quality and appropriateness of patient care;2.
Improve patient care;3.
Identify, resolve, and establish the root cause of dispensing and drug utilization review errors; and4.
Implement measures to prevent recurrence;(b)
Develop, implement, and enforce a procedure for identifying the pharmacist, intern, and pharmacy technician responsible for telework functions; and(c)
Develop, implement, and enforce a process for a virtual inspection of each telework site where a pharmacist technician is assisting in the practice of pharmacy or a pharmacist intern is engaged in the practice of pharmacy by a pharmacist at least once every twelve (12) months or more frequently as determinedSection 4.
Electronic Supervision Requirements. The pharmacy, pharmacist-in-charge, or the designee appointed by the pharmacist in charge and the supervising pharmacist from the pharmacy shall:(1)
Utilize an electronic communication system and have appropriate technology or interface to allow access to information required to complete assigned duties;(2)
Ensure a pharmacist is supervising and directing each intern and pharmacy technician and that the electronic communication system is operational;(3)
Ensure that a pharmacist, using professional judgment, determines the frequency of check-ins with registrants to ensure patient safety, competent practice, and compliance with federal and state laws.(4)
Ensure that a pharmacist is readily available to answer questions and be fully responsible for the practice and accuracy of the registrant; and(5)
Ensure the intern or pharmacy technician knows the identity of the pharmacist who is providing supervision and direction.Section 5.
Confidentiality. The Kentucky permitted pharmacy, pharmacist-in-charge of the pharmacy, or the designee appointed by the pharmacist in charge, and the pharmacist, intern, and pharmacy technician shall:(1)
Ensure patient and prescription information is managed in compliance with current state and federal law;(2)
Ensure the security and confidentiality of patient information and pharmacy records;(3)
Document in writing and report to the board within ten (10) days of discovery any confirmed breach in the security of the system or breach of confidentiality; and(4)
Report any breach of security or confidentiality to the Kentucky permitted pharmacy within twenty-four (24) hours of discovery and to the board within ten (10) days.Section 6.
Technology. The pharmacist-in-charge or the designee appointed by the pharmacist in charge shall:(1)
Test the electronic communication system with the telework site and document that it operates properly before the intern or pharmacy technician engages in telework at the telework site;(2)
Develop, implement, and enforce a plan for responding to and recovering from an interruption of service which prevents a pharmacist from supervising and directing the intern and pharmacy technician at the telework site;(3)
Ensure access to appropriate and current pharmaceutical references based on the services offered and shall include Kentucky Revised Statutes, Kentucky Administrative Regulations, United States Code, Code of Federal Regulations, standards adopted by reference, and the Board of Pharmacy quarterly newsletters; and(4)
Train the pharmacists, interns, and pharmacy technicians in the operation of the electronic communication system.Section 7.
Security.(1)
The pharmacist-in-charge or the designee appointed by the pharmacist in charge and each pharmacist supervising a telework site shall ensure(2)
Confidentiality shall be maintained so(3)
All computer equipment used for telework shall:(a)
Establish and maintain a secure connection to the pharmacy and patient information;(b)
Utilize a program that prevents unauthorized access to the pharmacy and patient information; and(c)
Ensure the pharmacy and patient information is not accessed if1.
There is not a2.
There is not an3.
Any component of the electronic communication system is not functioning; or(d)
Be configured so information from any patient or pharmacy records are not duplicated, downloaded, or removed from the electronic database if(4)
A record shall be maintained with the date, time, and identification of the licensee or registrant accessing patient or pharmacy records at a telework site.(5)
All records shall be stored in a secure manner that prevents access by unauthorized persons.Section 8.
Policies and Procedures.(1)
The pharmacy and the pharmacist-in-charge, or the designee appointed by the pharmacist in charge shall be(2)
The written policies and procedures shall include the services and responsibilities of the licensee or registrant engaging in telework including:(a)
Security;(b)
Operation, testing, training, and maintenance of the electronic communication system;(c)
Detailed description of work performed;(d)
Pharmacist supervision and direction of interns and pharmacy technicians;(e)
Recordkeeping;(f)
Patient confidentiality;(g)
Continuous quality improvement;(h)
Plan for discontinuing and recovering services if the electronic communication system is disrupted;(i)
Confirmation of secure telework sites;(j)
Documenting the identity, function, location, date, and time of the licensees engaging in telework at a telework site;(k)
Written agreement with contracted licensees engaging in telework outlining the specific functions performed and requirement to comply with telework policies and procedures; and(l)
Equipment.Section 9.
Records.(1)
The recordkeeping requirements of this administrative regulation shall be(2)
A pharmacy utilizing registrants or licensees via telework shall be able to produce a record of each pharmacist, pharmacist intern, or pharmacy technician involved in each order entry function. The record shall include the date and time when each step function was completed.(3)
Physical records shall not be stored at the telework site.(4)
Records shall not be duplicated, downloaded, or removed if(5)
Records shall be stored in a manner that prevents unauthorized access.(6)
Records shall include items such as(a)
Patient profiles and records;(b)
Patient contact and services provided;(c)
Date, time, and identification of the licensee or registrant accessing patient or pharmacy records;(d)
If processing prescriptions, date, time, and identification of the licensee or registrant and the specific activity or function of the person performing each step in the process;(e)
Training records;(f)
Virtual inspections;(g)
List of employees performing telework that includes:1.
Name;2.
License or registration number and expiration date;3.
Address of telework site; and4.
Name of the Kentucky licensed pharmacist who:a.
Supervised the intern or pharmacy technician;b.
Approved licensee to telework; andc.
Approved each telework site; and(h)
Electronic communication system testing and training.Section 10.
Prohibited Practices. Final product verification and dispensing from a location outside of or other than a permitted pharmacy shall not occurFILED WITH LRC: November 13, 2024
CONTACT PERSON: Christopher Harlow, Executive Director, Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building Annex, Frankfort, Kentucky 40601, phone (502) 564-7910, fax (502) 696-3806, email Christopher.harlow@ky.gov.
BOARDS AND COMMISSIONS
Board of Pharmacy
(Amended at ARRS Committee)
201 KAR 2:480.Telework and electronic supervision for remote prescription processing.
Section 1.
Definitions.(1)
"Electronic Supervision" means the oversight provided by a pharmacist licensed in Kentucky and supervising, by means of a real-time electronic communication system, a pharmacist intern or registered pharmacy technician who is working for a permitted pharmacy.(2)
"Telework" means the practice or assistance in the practice of pharmacy by a contractor or an employee of the pharmacy from a remote location outside of the permitted pharmacy.(3)
"Telework Functions" means:(a)
For a pharmacist includes:1.
Receiving, interpreting, or clarifying medical orders or prescription drug orders;2.
Order entry and order entry verification;3.
Transfer of prescription information;4.
Prospective drug utilization reviews;5.
Interpretation of clinical data;6.
Refill authorizations;7.
Performing therapeutic intervention; and8.
Patient counseling; and(b)
For a pharmacy technician are limited to tasks authorized under KRS 315.020(5).(4)
"Telework Site" means a location within the United States where a pharmacy technician assists in the practice of pharmacy, or a pharmacist or pharmacist intern engages in the practice of pharmacy as a contractor or an employee outside of the pharmacy located and permitted in Kentucky.Section 2.
Registration. The pharmacy and the pharmacist-in-charge of the pharmacy shall ensure individuals at telework sites are licensed or registered with the board.Section 3.
Requirements.(1)
The pharmacy and pharmacist-in-charge, or the designee appointed by the pharmacist in charge shall ensure that interns and pharmacy technicians working under electronic supervision are supervised by a Kentucky licensed pharmacist.(2)
A pharmacist or intern that engages in the practice of pharmacy and a pharmacy technician that assists in the practice of pharmacy at a telework site shall be licensed or registered by the board and shall comply with all applicable federal and state law.(3)
Prescription drugs and related devices shall not be at a telework site.(4)
The pharmacy utilizing telework functions shall:(a)
Possess a written agreement with the licensee or registrant that includes all conditions, duties, and policies governing the licensee or registrant engaged in telework activities;(b)
Maintain a continuously updated, readily retrievable, list of all licensees and registrants engaged in telework and the:1.
Address and phone number for each telework site;2.
Functions being performed by licensees or registrants engaged in telework; and3.
The name of the pharmacist providing supervision for each non-pharmacist registrant.(5)
The pharmacist-in-charge or the designee appointed by the pharmacist in charge of a pharmacy utilizing telework functions shall:(a)
Develop, implement, and enforce a continuous quality improvement program designed to objectively and systematically:1.
Monitor, evaluate, and document the quality and appropriateness of patient care;2.
Improve patient care;3.
Identify, resolve, and establish the root cause of dispensing and drug utilization review errors; and4.
Implement measures to prevent recurrence;(b)
Develop, implement, and enforce a procedure for identifying the pharmacist, intern, and pharmacy technician responsible for telework functions; and(c)
Develop, implement, and enforce a process for a virtual inspection of each telework site where a pharmacist technician is assisting in the practice of pharmacy or a pharmacist intern is engaged in the practice of pharmacy by a pharmacist at least once every twelve (12) months or more frequently as determined necessary by the pharmacist. The inspection shall be documented and records retained. Board staff may request and participate in virtual inspections.Section 4.
Electronic Supervision Requirements. The pharmacy, pharmacist-in-charge, or the designee appointed by the pharmacist in charge and the supervising pharmacist from the pharmacy shall:(1)
Utilize an electronic communication system and have appropriate technology or interface to allow access to information required to complete assigned duties;(2)
Ensure a pharmacist is supervising and directing each intern and pharmacy technician and that the electronic communication system is operational;(3)
Ensure that a pharmacist, using professional judgment, determines the frequency of check-ins with registrants to ensure patient safety, competent practice, and compliance with federal and state laws.(4)
Ensure that a pharmacist is readily available to answer questions and be fully responsible for the practice and accuracy of the registrant; and(5)
Ensure the intern or pharmacy technician knows the identity of the pharmacist who is providing supervision and direction.Section 5.
Confidentiality. The Kentucky permitted pharmacy, pharmacist-in-charge of the pharmacy, or the designee appointed by the pharmacist in charge, and the pharmacist, intern, and pharmacy technician shall:(1)
Ensure patient and prescription information is managed in compliance with current state and federal law;(2)
Ensure the security and confidentiality of patient information and pharmacy records;(3)
Document in writing and report to the board within ten (10) days of discovery any confirmed breach in the security of the system or breach of confidentiality; and(4)
Report any breach of security or confidentiality to the Kentucky permitted pharmacy within twenty-four (24) hours of discovery and to the board within ten (10) days.Section 6.
Technology. The pharmacist-in-charge or the designee appointed by the pharmacist in charge shall:(1)
Test the electronic communication system with the telework site and document that it operates properly before the intern or pharmacy technician engages in telework at the telework site;(2)
Develop, implement, and enforce a plan for responding to and recovering from an interruption of service which prevents a pharmacist from supervising and directing the intern and pharmacy technician at the telework site;(3)
Ensure access to appropriate and current pharmaceutical references based on the services offered and shall include Kentucky Revised Statutes, Kentucky Administrative Regulations, United States Code, Code of Federal Regulations, standards adopted by reference, and the Board of Pharmacy quarterly newsletters; and(4)
Train the pharmacists, interns, and pharmacy technicians in the operation of the electronic communication system.Section 7.
Security.(1)
The pharmacist-in-charge or the designee appointed by the pharmacist in charge and each pharmacist supervising a telework site shall ensure the telework site has a designated work area that is secure and has been approved by a pharmacist prior to utilization.(2)
Confidentiality shall be maintained so that patient information cannot be viewed or overheard by anyone other than the pharmacist, intern, or pharmacy technician.(3)
All computer equipment used for telework shall:(a)
Establish and maintain a secure connection to the pharmacy and patient information;(b)
Utilize a program that prevents unauthorized access to the pharmacy and patient information; and(c)
Ensure the pharmacy and patient information is not accessed if:1.
There is not a pharmacist actively supervising the intern or pharmacy technician at a telework site;2.
There is not an intern or pharmacy technician present at the electronically supervised telework site; or3.
Any component of the electronic communication system is not functioning; or(d)
Be configured so information from any patient or pharmacy records are not duplicated, downloaded, or removed from the electronic database if an electronic database is accessed remotely.(4)
A record shall be maintained with the date, time, and identification of the licensee or registrant accessing patient or pharmacy records at a telework site.(5)
All records shall be stored in a secure manner that prevents access by unauthorized persons.Section 8.
Policies and Procedures.(1)
The pharmacy and the pharmacist-in-charge, or the designee appointed by the pharmacist in charge shall be accountable for establishing, maintaining, and enforcing written policies and procedures for the licensees working via telework. The written policies and procedures shall be maintained at the pharmacy and shall be available to the board upon request.(2)
The written policies and procedures shall include the services and responsibilities of the licensee or registrant engaging in telework including:(a)
Security;(b)
Operation, testing, training, and maintenance of the electronic communication system;(c)
Detailed description of work performed;(d)
Pharmacist supervision and direction of interns and pharmacy technicians;(e)
Recordkeeping;(f)
Patient confidentiality;(g)
Continuous quality improvement;(h)
Plan for discontinuing and recovering services if the electronic communication system is disrupted;(i)
Confirmation of secure telework sites;(j)
Documenting the identity, function, location, date, and time of the licensees engaging in telework at a telework site;(k)
Written agreement with contracted licensees engaging in telework outlining the specific functions performed and requirement to comply with telework policies and procedures; and(l)
Equipment.Section 9.
Records.(1)
The recordkeeping requirements of this administrative regulation shall be in addition to 201 KAR 2:171.(2)
A pharmacy utilizing registrants or licensees via telework shall be able to produce a record of each pharmacist, pharmacist intern, or pharmacy technician involved in each order entry function. The record shall include the date and time when each step function was completed.(3)
Physical records shall not be stored at the telework site.(4)
Records shall not be duplicated, downloaded, or removed if accessed via telework.(5)
Records shall be stored in a manner that prevents unauthorized access.(6)
Records shall include items such as:(a)
Patient profiles and records;(b)
Patient contact and services provided;(c)
Date, time, and identification of the licensee or registrant accessing patient or pharmacy records;(d)
If processing prescriptions, date, time, and identification of the licensee or registrant and the specific activity or function of the person performing each step in the process;(e)
Training records;(f)
Virtual inspections;(g)
List of employees performing telework that includes:1.
Name;2.
License or registration number and expiration date;3.
Address of telework site; and4.
Name of the Kentucky licensed pharmacist who:a.
Supervised the intern or pharmacy technician;b.
Approved licensee to telework; andc.
Approved each telework site; and(h)
Electronic communication system testing and training.Section 10.
Prohibited Practices. Final product verification and dispensing from a location outside of or other than a permitted pharmacy shall not occur in telework.FILED WITH LRC: November 13, 2024
CONTACT PERSON: Christopher Harlow, Executive Director, Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building Annex, Frankfort, Kentucky 40601, phone (502) 564-7910, fax (502) 696-3806, email Christopher.harlow@ky.gov.