Title 201 | Chapter 002 | Regulation 210REG
PROPOSED
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BOARDS AND COMMISSIONS
Board of Pharmacy
(Amended at ARRS Committee)
201 KAR 2:210.Patient records, drug regimen review, patient counseling, and final product verificationand patient counseling.
Section 1.
Definitions.(1)
"Automated filling system":(a)
Means an automated system used by a pharmacy to assist in filling a prescription drug order or medical order by selecting, labeling, filling, or sealing medication for dispensing; and(b)
Does(2)
(3)
"Dispense" or "dispensing" is defined by KRS (3)(4)
"Electronic verification" means the non-physical visual verification a pharmacist utilizes to verify the accuracy of the final contents of the prepared prescription product and affixed label prior to dispensing.(4)(5)
"Electronic verification system" means an electronic verification, bar code verification, weight verification, radio frequency identification, or similar electronic process or system that accurately verifies medication has been properly prepared and labeled by, or loaded into, an automated filling system.(5)(6)
"Final product verification" means the process a pharmacist utilizes to verify the accuracy of the final contents of any prepared prescription product and affixed label prior to dispensing.(6)(7)
"Manufacturer unit of use package" means a drug dispensed in the manufacturer's original and sealed packaging, or in the original and sealed packaging of a re-packager, without additional manipulation or preparation by the pharmacy, except for application of the pharmacy label.(7)(8)
"Medical Order" is defined by KRS 315.010(14).(8)(9)
"Prepared prescription product" means(9)(10)
"Prescription drug order" is defined by KRS 315.010(25).(10)(11)
"Re-packager" means a re-packager registered with the United States Food and Drug Administration.(11)(12)
"Repacked" means any drug that has been removed from the original packaging of the manufacturer or a re-packager's packaging and is placed in a container for use in an automated filling system.Section 2.
Patient Records.(1)
(a)
A patient record system shall, with the exercise of professional judgment, be maintained by a pharmacy for patients for whom prescription drug or medical orders(2)(b)
A pharmacist, with the exercise of professional judgment, shall establish a procedure for obtaining, recording, and maintaining information required for a patient record.(3)(c)
A pharmacist, or a pharmacy technician or a pharmacist intern(4)(d)
A patient record shall:(a)1.
Be readily retrievable by manual or electronic means;(b)2.
Enable the pharmacist to identify previously dispensed drugs and known disease conditions;(c)3.
Enable the pharmacist to determine the impact of previously dispensed drugs and known disease conditions upon the newly submitted prescription drug or medical order(d)4.
Be maintained for not less than 180 days from the date of the last entry.(5)(2)
A patient record shall include:(a)
Full name of patient or animal for whom the drug is intended;(b)
Address and telephone number of the patient;(c)
Patient's age or date of birth;(d)
Patient's gender;(e)
A list of all prescriptions received by the pharmacy or dispensed to1.
Prescription number;2.
Name and strength of medication;3.
Quantity;4.
Date received;5.
Identity of prescriber; and6.
Comments or other information as may be relevant to the specific patient or drug; and(f)
Individual medical history if significant, including known disease states, known allergies, idiosyncrasies, reactions or conditions relating to prospective drug use and drug regimen reviews.Section 3.Section 2.
Prospective Drug Regimen Review.(1)
A pharmacist shall conduct a prospective drug regimen review(2)
It shall include an assessment of a patient's drug therapy and the prescription order.(3)
A prospective drug regimen review shall include a review by the pharmacist of the following:(a)
Known allergies;(b)
Rationale for use;(c)
Proper dose, route of administration, and directions;(d)
Synergism with currently employed modalities;(e)
Interaction or adverse reaction with applicable:1.
Drugs;2.
Foods; or3.
Known disease states;(f)
Proper utilization for optimum therapeutic outcomes; and(g)
Clinical misuse or abuse.Section 4.
Automated Filling Systems.(1)
Automated filling systems shall be stocked or loaded by a pharmacist, or by a pharmacist intern or certified pharmacy technician under the supervision of a pharmacist. A registered pharmacy technician may stock or load an automated filling system under the immediate supervision of a pharmacist.(2)
A licensed pharmacist shall inspect and verify the accuracy of the final contents of any prepared prescription product filled or packaged by an automated filling system and the affixed label(a)
The filling process is fully automated from the time the filling process is initiated until a completed, labeled, and sealed prepared prescription product is produced by the automated filling system that is ready for dispensing to the patient.(b)
A pharmacist verifies the accuracy of the prescription information used by or entered into the automated filling system for a specific patient prior to initiation of the automatic fill process. The name, initials, or identification code of the verifying pharmacist shall be recorded in the pharmacy's records and maintained for five (5) years after dispensing;(c)
The pharmacy establishes and follows a policy and procedure manual that complies with this administrative regulation;(d)
A pharmacist verifies the correct medication, repackaged container, or manufacturer unit of use package was properly stocked, filled, and loaded in the automated filling system prior to initiating the fill process. Alternatively, an electronic verification system may be used for verification of manufacturer unit of use packages or repacked medication previously verified by a pharmacist. The name, initials, or identification code of the verifying pharmacist shall be recorded in the pharmacy's records and maintained for five (5) years after dispensing;(e)
The medication to be dispensed is filled, labeled, and sealed in the prescription container by the automated filling system or dispensed by the system in a manufacturer's unit of use package or a repacked pharmacy container;(f)
An electronic verification system is used to verify the proper prescription label has been affixed to the correct medication, repackaged container, or manufacturer unit of use package for the correct patient; and(g)
Daily random quality testing is conducted by a pharmacist on a sample size of prescriptions filled by an automated filling system. The required sample size shall be at least(3)
Pharmacies verifying prescriptions utilizing the method in subsection (2) of this section shall establish and follow written policies and procedures to ensure the proper, safe, and secure functioning of the system. Policies and procedures shall be reviewed annually by the pharmacist in charge and shall be maintained in the pharmacy's records for a minimum of five (5) years. The required annual review shall be documented in the pharmacy's records and made available upon request.(4)
At a minimum, the pharmacy shall establish and follow policies and procedures for:(a)
Maintaining the automated filling system and any accompanying electronic verification system in good working order;(b)
Ensuring accurate filling, loading, and stocking of the system;(c)
Ensuring sanitary operations of the system and preventing cross-contamination of cells, cartridges, containers, cassettes, or packages;(d)
Reporting, investigating, and addressing filling errors and system malfunctions;(e)
Testing the accuracy of the automated filling system and any accompanying electronic verification system. At a minimum, the automated filling system and electronic verification system shall be tested before the first use of the system or restarting the system and upon any modification to the automated filling system or electronic verification system that changes or alters the filling or electronic verification process;(f)
Training persons authorized to access, stock, restock, or load the automated filling system in equipment use and operations;(g)
Tracking and documenting prescription errors related to the automated filling system that are not corrected prior to dispensing to the patient.(h)
Conducting routine and preventative maintenance, and, if applicable, calibration;(i)
Removing expired, adulterated, misbranded, or recalled drugs;(j)
Preventing unauthorized access to the system, including assigning, discontinuing, or changing security access;(k)
Identifying and recording persons responsible for stocking, loading, and filling the system;(l)
Ensuring compliance with state and federal law, including, all applicable labeling, storage and security requirements; and(m)
Maintaining an ongoing quality assurance program that monitors performance of the automatic fill system and any electronic verification system to ensure proper and accurate functioning.(5)
Records required by this administrative regulation shall be maintained by the pharmacy's records electronically or in writing for a minimum of five (5) years. When the verification requirements of subsection (2) of this section are completed by a pharmacist, the name, initials or identification code of the verifying pharmacist shall be recorded in the pharmacy's records and maintained for five (5) years after dispensing. Records shall be made available for inspection and produced to the board upon request.Section 5.
Final Product Verification.(1)
A pharmacist shall conduct final product verification of a prepared prescription product(2)
(3)
The identity of the pharmacist responsible for verifying the prepared prescription product shall be documented in the pharmacy's records.(4)
A mechanism shall be in place to record and communicate the pharmacist's verification.(5)
A licensed pharmacist may use an electronic verification system to verify the accuracy of a final prepared prescription product if:(a)
The electronic verification system allows the pharmacist to see an exact, clear, and unobstructed visual image or images of the prepared prescription product contents and the label affixed to the container. If multiple units are being dispensed, the pharmacist shall be able to see and verify an image or images of each unit and each individual affixed label;(b)
Pharmacy technicians and pharmacist interns preparing a prescription to be verified with electronic verification shall be trained and competent to perform the duties assigned and have a documented initial and annual assessment of competency using the pharmacy's approved electronic verification system;(c)
The pharmacy maintains an ongoing quality assurance program that monitors performance of the electronic verification system to ensure proper and accurate functioning and includes(d)
The pharmacy maintains records required by this administrative regulation(6)
Compounded preparations shall not be verified electronically. Compounded preparations shall be physically verified by a pharmacist.(7)
Final product verification of a prescription shall only occur on the premises of the originating pharmacy notwithstanding any final product verification occurring under 201 KAR 2:230 unless a permit holder has received prior board approval. A single request may be made for commonly owned permit holders, and approval or denial may be issued in the aggregate based on common ownership.(8)
The board may, upon a petition by a permit holder and uponSection 6.
Patient Counseling.(1)
The pharmacist shall offer to counsel a patient on matters which the pharmacist(a)
Upon the presentation of an original prescription order; and(b)
On refill prescriptions, as professional discretion dictates.(2)
(a)
The offer shall be made by the pharmacist in a face-to-face communication with the patient or caregiver, unless, in the professional judgment of the pharmacist, it is found(3)(b)
If found(a)1.
By the pharmacy technician or pharmacist intern(b)2.
In written communication;(c)3.
By telephone(d)4.
In another manner determined by the pharmacist to be appropriate.(4)(3)
Patient counseling shall be:(a)
In person if(b)
With reasonable effort, by telephone or real-time video.(5)(4)
The pharmacist shall include the following elements of patient counseling that the pharmacist(a)
The name and description of the drug;(b)
The dosage form, dose, route of administration, and duration of therapy;(c)
Special directions and precautions;(d)
Common and clinically significant adverse effects, interactions, or contraindications that may be encountered, including the(e)
Techniques for self-monitoring of drug therapy;(f)
Proper storage;(g)
Refill information;(h)
Action to be taken if(i)
The pharmacist's(j)
Any other information peculiar to the specific patient or drug.(6)(5)
If a pharmacist determines that it is appropriate, the pharmacist(a)
Written, electronic, or printed information leaflets;(b)
Pictogram labels; and(c)
Video programs.(7)(6)
Mail-order pharmacies shall be subject to the same counseling requirements as any other pharmacy.Section 7.
Documentation of Counseling.(1)
A record that the patient refused the pharmacist's offer to counsel shall be maintained for one (1) year.(2)
If there is no record that the patient refused the pharmacist's offer to counsel, there shall be a presumption that:(a)
The offer to counsel, as required in Section 6(b)
The counseling was provided.Section 8.Section 3.
Confidentiality.(1)
A patient record shall be held in confidence.(2)
It shall be communicated or released:(a)
To the patient;(b)
As the patient directs; or(c)
As prudent, professional discretion dictates.Section 4.
(1)
(2)
(3)
(a)
(b)
(c)
(d)
(e)
1.
2.
3.
(f)
(g)
Section 5.
(1)
(2)
(a)
(b)
Section 9.Section 6.
The provisions of this administrative regulation shall not apply:(1)
To(2)
Compliance with 902 KAR 20:016FILED WITH LRC: December 9, 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 2:210.Patient records, drug regimen review, patient counseling, and final product verification.
Section 1.
Definitions.(1)
"Automated filling system":(a)
Means an automated system used by a pharmacy to assist in filling a prescription drug order or medical order by selecting, labeling, filling, or sealing medication for dispensing; and(b)
Does not include an automated device used solely to count medication, vacuum tube drug delivery systems, automated pharmacy systems as defined in KRS 218A.185, or automated dispensing systems as defined in 201 KAR 2:370.(2)
"Dispense" or "dispensing" is defined by KRS 217.015(9), 218A.010(11), and 315.010(9).(3)
"Electronic verification" means the non-physical visual verification a pharmacist utilizes to verify the accuracy of the final contents of the prepared prescription product and affixed label prior to dispensing.(4)
"Electronic verification system" means an electronic verification, bar code verification, weight verification, radio frequency identification, or similar electronic process or system that accurately verifies medication has been properly prepared and labeled by, or loaded into, an automated filling system.(5)
"Final product verification" means the process a pharmacist utilizes to verify the accuracy of the final contents of any prepared prescription product and affixed label prior to dispensing.(6)
"Manufacturer unit of use package" means a drug dispensed in the manufacturer's original and sealed packaging, or in the original and sealed packaging of a re-packager, without additional manipulation or preparation by the pharmacy, except for application of the pharmacy label.(7)
"Medical Order" is defined by KRS 315.010(14).(8)
"Prepared prescription product" means a prescription drug or medical order prepared for dispensing by a pharmacist.(9)
"Prescription drug order" is defined by KRS 315.010(25).(10)
"Re-packager" means a re-packager registered with the United States Food and Drug Administration.(11)
"Repacked" means any drug that has been removed from the original packaging of the manufacturer or a re-packager's packaging and is placed in a container for use in an automated filling system.Section 2.
Patient Records.(1)
A patient record system shall, with the exercise of professional judgment, be maintained by a pharmacy for patients for whom prescription drug or medical orders are dispensed at that pharmacy location.(2)
A pharmacist, with the exercise of professional judgment, shall establish a procedure for obtaining, recording, and maintaining information required for a patient record.(3)
A pharmacist, or a pharmacy technician or a pharmacist intern, shall obtain, record, and maintain the information for a patient record.(4)
A patient record shall:(a)
Be readily retrievable by manual or electronic means;(b)
Enable the pharmacist to identify previously dispensed drugs and known disease conditions;(c)
Enable the pharmacist to determine the impact of previously dispensed drugs and known disease conditions upon the newly submitted prescription drug or medical order; and(d)
Be maintained for not less than 180 days from the date of the last entry.(5)
A patient record shall include:(a)
Full name of patient or animal for whom the drug is intended;(b)
Address and telephone number of the patient;(c)
Patient's age or date of birth;(d)
Patient's gender;(e)
A list of all prescriptions received by the pharmacy or dispensed to the patient at that pharmacy location for the past twelve (12) months by:1.
Prescription number;2.
Name and strength of medication;3.
Quantity;4.
Date received;5.
Identity of prescriber; and6.
Comments or other information as may be relevant to the specific patient or drug; and(f)
Individual medical history if significant, including known disease states, known allergies, idiosyncrasies, reactions or conditions relating to prospective drug use and drug regimen reviews.Section 3.
Prospective Drug Regimen Review.(1)
A pharmacist shall conduct a prospective drug regimen review prior to dispensing.(2)
It shall include an assessment of a patient's drug therapy and the prescription order.(3)
A prospective drug regimen review shall include a review by the pharmacist of the following:(a)
Known allergies;(b)
Rationale for use;(c)
Proper dose, route of administration, and directions;(d)
Synergism with currently employed modalities;(e)
Interaction or adverse reaction with applicable:1.
Drugs;2.
Foods; or3.
Known disease states;(f)
Proper utilization for optimum therapeutic outcomes; and(g)
Clinical misuse or abuse.Section 4.
Automated Filling Systems.(1)
Automated filling systems shall be stocked or loaded by a pharmacist, or by a pharmacist intern or certified pharmacy technician under the supervision of a pharmacist. A registered pharmacy technician may stock or load an automated filling system under the immediate supervision of a pharmacist.(2)
A licensed pharmacist shall inspect and verify the accuracy of the final contents of any prepared prescription product filled or packaged by an automated filling system and the affixed label prior to dispensing. A pharmacist shall be found to have verified the prepared prescription product and the affixed label if:(a)
The filling process is fully automated from the time the filling process is initiated until a completed, labeled, and sealed prepared prescription product is produced by the automated filling system that is ready for dispensing to the patient. Manual intervention with the medication or prepared prescription product shall not occur after the medication is loaded into the automated filling system. Manual intervention shall not include preparing a finished prepared prescription product for mailing, delivery, or storage;(b)
A pharmacist verifies the accuracy of the prescription information used by or entered into the automated filling system for a specific patient prior to initiation of the automatic fill process. The name, initials, or identification code of the verifying pharmacist shall be recorded in the pharmacy's records and maintained for five (5) years after dispensing;(c)
The pharmacy establishes and follows a policy and procedure manual that complies with this administrative regulation;(d)
A pharmacist verifies the correct medication, repackaged container, or manufacturer unit of use package was properly stocked, filled, and loaded in the automated filling system prior to initiating the fill process. Alternatively, an electronic verification system may be used for verification of manufacturer unit of use packages or repacked medication previously verified by a pharmacist. The name, initials, or identification code of the verifying pharmacist shall be recorded in the pharmacy's records and maintained for five (5) years after dispensing;(e)
The medication to be dispensed is filled, labeled, and sealed in the prescription container by the automated filling system or dispensed by the system in a manufacturer's unit of use package or a repacked pharmacy container;(f)
An electronic verification system is used to verify the proper prescription label has been affixed to the correct medication, repackaged container, or manufacturer unit of use package for the correct patient; and(g)
Daily random quality testing is conducted by a pharmacist on a sample size of prescriptions filled by an automated filling system. The required sample size shall be at least two (2) percent of the prescriptions filled by the automated system on the date tested or two (2) percent of the prescriptions filled by the automated system on the last day of system operation, as designated in writing by the pharmacist in charge. Proof of compliance, including date and results, of daily random quality testing shall be maintained and documented in the pharmacy's records.(3)
Pharmacies verifying prescriptions utilizing the method in subsection (2) of this section shall establish and follow written policies and procedures to ensure the proper, safe, and secure functioning of the system. Policies and procedures shall be reviewed annually by the pharmacist in charge and shall be maintained in the pharmacy's records for a minimum of five (5) years. The required annual review shall be documented in the pharmacy's records and made available upon request.(4)
At a minimum, the pharmacy shall establish and follow policies and procedures for:(a)
Maintaining the automated filling system and any accompanying electronic verification system in good working order;(b)
Ensuring accurate filling, loading, and stocking of the system;(c)
Ensuring sanitary operations of the system and preventing cross-contamination of cells, cartridges, containers, cassettes, or packages;(d)
Reporting, investigating, and addressing filling errors and system malfunctions;(e)
Testing the accuracy of the automated filling system and any accompanying electronic verification system. At a minimum, the automated filling system and electronic verification system shall be tested before the first use of the system or restarting the system and upon any modification to the automated filling system or electronic verification system that changes or alters the filling or electronic verification process;(f)
Training persons authorized to access, stock, restock, or load the automated filling system in equipment use and operations;(g)
Tracking and documenting prescription errors related to the automated filling system that are not corrected prior to dispensing to the patient. Documentation shall be maintained for five (5) years and produced to the board upon request;(h)
Conducting routine and preventative maintenance, and, if applicable, calibration;(i)
Removing expired, adulterated, misbranded, or recalled drugs;(j)
Preventing unauthorized access to the system, including assigning, discontinuing, or changing security access;(k)
Identifying and recording persons responsible for stocking, loading, and filling the system;(l)
Ensuring compliance with state and federal law, including, all applicable labeling, storage and security requirements; and(m)
Maintaining an ongoing quality assurance program that monitors performance of the automatic fill system and any electronic verification system to ensure proper and accurate functioning.(5)
Records required by this administrative regulation shall be maintained by the pharmacy's records electronically or in writing for a minimum of five (5) years. When the verification requirements of subsection (2) of this section are completed by a pharmacist, the name, initials or identification code of the verifying pharmacist shall be recorded in the pharmacy's records and maintained for five (5) years after dispensing. Records shall be made available for inspection and produced to the board upon request.Section 5.
Final Product Verification.(1)
A pharmacist shall conduct final product verification of a prepared prescription product prior to delivery of the prepared prescription product to the patient.(2)
Further manipulation of a prepared prescription product shall not occur after the pharmacist's verification is complete other than applying the required container lid or seal and preparing the prepared prescription product for mailing, delivery, or storage.(3)
The identity of the pharmacist responsible for verifying the prepared prescription product shall be documented in the pharmacy's records.(4)
A mechanism shall be in place to record and communicate the pharmacist's verification.(5)
A licensed pharmacist may use an electronic verification system to verify the accuracy of a final prepared prescription product if:(a)
The electronic verification system allows the pharmacist to see an exact, clear, and unobstructed visual image or images of the prepared prescription product contents and the label affixed to the container. If multiple units are being dispensed, the pharmacist shall be able to see and verify an image or images of each unit and each individual affixed label;(b)
Pharmacy technicians and pharmacist interns preparing a prescription to be verified with electronic verification shall be trained and competent to perform the duties assigned and have a documented initial and annual assessment of competency using the pharmacy's approved electronic verification system;(c)
The pharmacy maintains an ongoing quality assurance program that monitors performance of the electronic verification system to ensure proper and accurate functioning and includes procedures for system outages; and(d)
The pharmacy maintains records required by this administrative regulation electronically or in writing for a minimum of five (5) years. Records shall be made available for inspection and produced to the board upon request.(6)
Compounded preparations shall not be verified electronically. Compounded preparations shall be physically verified by a pharmacist.(7)
Final product verification of a prescription shall only occur on the premises of the originating pharmacy notwithstanding any final product verification occurring under 201 KAR 2:230 unless a permit holder has received prior board approval. A single request may be made for commonly owned permit holders, and approval or denial may be issued in the aggregate based on common ownership.(8)
The board may, upon a petition by a permit holder and upon the balancing the best interest of the public health, safety, and welfare, waive a specific portion of this section.Section 6.
Patient Counseling.(1)
The pharmacist shall offer to counsel a patient on matters which the pharmacist believes will optimize drug therapy with each patient or caregiver:(a)
Upon the presentation of an original prescription order; and(b)
On refill prescriptions, as professional discretion dictates.(2)
The offer shall be made by the pharmacist in a face-to-face communication with the patient or caregiver, unless, in the professional judgment of the pharmacist, it is found impractical or inappropriate.(3)
If found impractical or inappropriate, the offer to counsel may be made:(a)
By the pharmacy technician or pharmacist intern;(b)
In written communication;(c)
By telephone; or(d)
In another manner determined by the pharmacist to be appropriate.(4)
Patient counseling shall be:(a)
In person if practical; or(b)
With reasonable effort, by telephone or real-time video.(5)
The pharmacist shall include the following elements of patient counseling that the pharmacist has determined are appropriate:(a)
The name and description of the drug;(b)
The dosage form, dose, route of administration, and duration of therapy;(c)
Special directions and precautions;(d)
Common and clinically significant adverse effects, interactions, or contraindications that may be encountered, including the avoidance and the action required if these occur;(e)
Techniques for self-monitoring of drug therapy;(f)
Proper storage;(g)
Refill information;(h)
Action to be taken if a missed dose;(i)
The pharmacist's comments relevant to the individual's therapy; and(j)
Any other information peculiar to the specific patient or drug.(6)
If a pharmacist determines that it is appropriate, the pharmacist may supplement patient counseling with additional forms of patient information, such as:(a)
Written, electronic, or printed information leaflets;(b)
Pictogram labels; and(c)
Video programs.(7)
Mail-order pharmacies shall be subject to the same counseling requirements as any other pharmacy.Section 7.
Documentation of Counseling.(1)
A record that the patient refused the pharmacist's offer to counsel shall be maintained for one (1) year.(2)
If there is no record that the patient refused the pharmacist's offer to counsel, there shall be a presumption that:(a)
The offer to counsel, as required in Section 6 of this administrative regulation, was made and accepted; and(b)
The counseling was provided.Section 8.
Confidentiality.(1)
A patient record shall be held in confidence.(2)
It shall be communicated or released:(a)
To the patient;(b)
As the patient directs; or(c)
As prudent, professional discretion dictates.Section 9.
The provisions of this administrative regulation shall not apply:(1)
To a hospital or institution if other licensed health-care professionals may administer the drugs; and(2)
Compliance with 902 KAR 20:016, 201 KAR 2:074 and 201 KAR 2:076 is maintained.FILED WITH LRC: December 9, 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.