CQI meetings must be held quarterly (every 90 days).

• K.A.R. 68-19-1

• Date of meeting
• Who attended
• Review and list all incident reports generated since last quarterly meeting
• What progressive preventative steps will be implemented to prevent future errors
• List of Board newsletter(s) reviewed since last CQI meeting
• Best practice is to utilize prescription numbers when identifying incident reports reviewed.
• CQI meeting reports must be made available to the Board for inspection.

K.S.A. 65-1695 and KAR 68-19-1

Any form may be used provided it includes all requirements of the statute and/or regulation. You may use the CQI Form provided by the Board and found under “Forms” on the Board website.

A sample Incident Report Form can be found on the Board website. Its use is not required, and pharmacies may use their own forms provided the requirements of K.A.R. 68-7-12b are met.

There are six (6) reportable incidents.

• The patient receiving the wrong drug
• The patient receiving an incorrect drug strength
• The patient receiving an incorrect dosage form
• The drug being received by the wrong patient
• Inadequate or incorrect packaging, labeling, or directions
• The dispensing of a drug to a patient in a situation that results in or has the potential to result in serious harm to the patient

K.A.R. 68-7-12b(c)

Yes. All pharmacy employees involved in the incident must sign the report and document registration or license number.

• K.A.R. 68-7-12b(c)(6)

Five (5) years.

• K.A.R. 68-7-12b(c)

• Yearly (no later than 375 days after the date of the previous inventory) and with Pharmacist in Charge (PIC) changes (outgoing and incoming PIC)
• All controlled substances and drugs of concern shall be inventoried on the same calendar date
• K.A.R. 68-20-16(b), K.A.R. 68-1-9(h)(2) & (3), and 21 C.F.R. 1304.11

• All on hand schedule II-V drugs and drugs of concern listed in K.A.R. 68-21-7.
  
  • Each of the following shall be classified as a drug of concern:
    
    1. Any product containing all three of these drugs: butalbital, acetaminophen, and caffeine;
    2. any compound, mixture, or preparation that contains any detectable quantity of ephedrine, its salts or optical isomers, or salts of optical isomers and is exempt from being reported to the statewide electronic logging system for the sale of methamphetamine precursors;
    3. any compound, mixture, or preparation that contains any detectable quantity of pseudoephedrine, its salts or optical isomers, or salts of optical isomers and is exempt from being reported to the statewide electronic logging system for the sale of methamphetamine precursors;
    4. promethazine with codeine; and
    5. any product, compound, mixture, or preparation that contains gabapentin.
• Do not forget to count and document any out of date (expired) controlled substances on the inventory.
• For retail pharmacies: This inventory must include will call bins, outdated drugs, C-V OTC drugs, and non-automated LTCF e-kits.
• For medical care facilities: This inventory must include automated drug dispensing systems, crash carts, med carts, emergency rooms, operating rooms, etc.
• Each required inventory of schedule II controlled substances and nonliquid dosage forms of other controlled substances and drugs of concern shall be taken by exact count.
• K.A.R. 68-20-16, 21 C.F.R. 1304.04(h), and 21 C.F.R. 1304.11

• It shall be maintained in legible, hard-copy format
• It shall include the following:
  
  • The date the inventory was conducted
  • The name, license or registration number, and signature of each individual participating in the inventory
  • Documentation of whether the inventory was taken before the opening of business or after the close of business.  If pharmacy is open 24 hours, the time that the count was taken shall be documented.
    
    • K.A.R. 68-20-16(e)

Yes. They shall be conspicuously displayed in the place for which the registration or permit was granted.

• K.S.A. 65-1645(f)

Yes. The original license and renewal card of a pharmacist must be displayed in full view of the public at the pharmacist’s primary place of employment. The current registration card of a technician must be displayed in the area in which the technician works at their primary place of employment.

• K.S.A. 65-1641 and K.S.A. 65-1663(j)

Yes. The addresses may be covered so they are not visible to the public.

All pharmacists, interns, or technicians shall wear a visible nametag stating the wearer’s name and position while performing those functions. This applies to all pharmacy settings.

• K.A.R. 68-2-15

Each pharmacist, intern, and technician is responsible for complying with the regulations regarding the posting of their license or registration and wearing their name tag.

• K.S.A. 65-1641, KSA 65-1676(h), K.A.R. 65-1663(j), and K.A.R. 68-2-15

K.A.R. 68-7-13 states “no pharmacist shall be a PIC of more than one full-time pharmacy which is defined as being one where the on-premises pharmacist services total 30 hours or more weekly.” A pharmacist could be a PIC at more than one pharmacy provided the required pharmacists’ services are less than 30 hours per week. A pharmacist may be a PIC at the same location where the facility has multiple registrations. For example, a pharmacist may be PIC at a non-resident pharmacy that is also applying for registration as an outsourcing facility.

The outgoing PIC must notify the Board no later than five (5) days after ceasing to be PIC. The notification must be made by either submitting section A of the PIC Change Form BA-50 to the Board office or completing the online PIC resignation option after logging into the pharmacist’s Board of Pharmacy eLicense account. The outgoing PIC must also inventory all controlled substances and drugs of concern, listed in K.A.R. 68-21-7(a) no more than two days prior to ceasing to be a PIC and no later than the day ceasing to serve as PIC.

• K.A.R. 68-2-5, K.A.R. 68-1-9

The PIC Change Form BA-50 may be mailed, emailed, or faxed to the Board office. Any mailed Form BA-50 must be postmarked no later than 5 days after the pharmacist’s last day as PIC.

If the outgoing PIC is unable to complete the final inventory or is terminated for a suspected or known violation of the Kansas pharmacy act, the pharmacy or facility owner shall request approval from the board to designate another pharmacist to conduct the inventory.

• K.A.R. 68-1-9(h)(4)

The pharmacy owner must obtain a new PIC with 30 days. If additional time is needed, the owner or authorized agent can complete section C of the PIC Change Form BA-50 and submit to the Board before the 30 days expires.

• K.A.R. 68-1-2a(c)(d)

• See K.A.R. 68-1-9 for responsibilities of ALL PICs
• For medical care facility specific responsibilities see K.A.R 68-7-11
• For a facility other than a medical care facility specific responsibilities see K.A.R 68-7-12
• Each pharmacist-in-charge shall be responsible for reviewing each published board newsletter and posting the newsletter in a conspicuous area within the pharmacy until publication of the next board newsletter.
  
  • It needs to be posted in an area where the staff can read it. It does not need to be posted for the public to read.
    
    • K.A.R. 68-1-9(g)

No. The PIC shall supervise the pharmacy on a full-time or part-time basis and shall be personally available to the extent required to ensure comprehensive pharmaceutical services within the pharmacy.

• K.S.A. 65-1626(xx) and K.A.R. 68-7-12(b)

The incoming PIC shall take a beginning inventory of ALL controlled substances and drugs of concern no more than two days after beginning to serve as the PIC and submit the completed PIC Change Form BA-50 to the Board.

The inventory may be taken simultaneously with the previous PIC on the last day of the previous PIC if both pharmacists are present in the pharmacy, actively participating in the inventory, and sign the inventory.

• K.A.R. 68-1-9

Each prospective PIC shall, at the time of assuming these duties, sign an acknowledgment that states the pharmacist has reviewed the pharmacy act and board’s regulations and is aware of the responsibilities of a pharmacist-in-charge and provide this acknowledgement to the board within 30 days of assuming the duties of PIC.

• K.A.R. 68-1-2a(b)

All controlled substance prescriptions in schedules II-IV plus five drugs of concern defined in K.A.R. 68-21-7 are required to be reported to K-TRACS. K.S.A. 65-1683 outlines the 16 data elements required to be reported for each prescription.

A “dispenser” is defined in K.S.A. 65-1682 as a “practitioner, pharmacy or pharmacist who delivers a scheduled substance or drug of concern to an ultimate user, but does not include:

• A licensed hospital pharmacy that distributes such substances for the purpose of inpatient hospital care;
• A medical care facility as defined in K.S.A. 65-425, and amendments thereto, practitioner or other authorized person who administers such a substance;
• A registered wholesale distributor of such substances;
• A veterinarian licensed by the Kansas board of veterinary examiners who dispenses or prescribes a scheduled substance or drug of concern; or
• A practitioner who has been exempted from the reporting requirements of this act in rules and regulations promulgated by the board.

An exemption request process is in place for dispensers who do not meet these requirements but also do not dispense controlled substances or drugs of concern in Kansas.

K.A.R. 68-21-7 defines drugs of concern as:

• Any product containing all three of these drugs: butalbital, acetaminophen and caffeine;
• Any compound, mixture or preparation that contains any detectable quantity of ephedrine, its salts or optical isomers, or salts of optical isomers and is exempt from being reported to the statewide electronic logging system for the sale of methamphetamine precursors;
• Any compound, mixture or preparation that contains any detectable quantity of pseudoephedrine, its salts or optical isomers, or salts of optical isomers and is exempt from being reported to the statewide electronic logging system for the sale of methamphetamine precursors; Promethazine with codeine; and
• Any product, compound, mixture or preparation that contains gabapentin.

Yes, a zero report is required to be submitted by the end of the next business day following a day in which no dispensations occur.

Only pharmacists-in-charge are permitted to correct errors within their K-TRACS account. If you are not a PIC, you will not be able to see the error list. If you are a PIC and are unable to see the errors for your pharmacy, contact K-TRACS to update your account information to receive the correct permissions.

Errors occur in prescriptions reported when missing or incorrect information is submitted. Pharmacists-in-charge (PICs) have access to correct errors by logging into their K-TRACS account, navigating to the Menu, then to Rx Management. Each prescription that contains errors is listed. Missing or incorrect information is highlighted within each prescription and can be corrected and re-submitted by the PIC.

Read: How to Correct Errors

No. A patient's physical address is required to be reported with the dispensation. PO boxes are not acceptable. You can obtain a patient's physical address from their driver's license, state ID or insurance card.

For veterinarians without NPI or DEA numbers, pharmacies should use the veterinarian's four-digit state license number in the state license number field. The DEA and NPI fields should be left blank.

For other types of prescribers without a DEA number, the NPI number should be used.

All controlled substance prescriptions must include a DEA number.

Animal prescriptions filled in pharmacies should be entered in pharmacy dispensing systems in the following manner:

• Use the animal's name as the patient name
• Use the human/owner's date of birth and address
• Select the patient type or species code as animal or non-human (required as of November 1, 2023)

Data entry at the pharmacy remains unchanged for these prescriptions. However, K-TRACS recommends pharmacy system vendors report the human/owner's information in the patient (PAT) fields in addition to the species code and animal name.

The distinction between human and non-human prescriptions is important for healthcare providers looking up human prescription history to use in their clinical decision-making, as well as in reporting prescription data in aggregate.

Read: How to Correct Animal Prescription Errors

Any employee becoming aware of diversion should report it immediately.

• 21 C.F.R. 1301.91

DEA Form 106. The report must be submitted to the DEA and to the Board of Pharmacy.

• K.A.R. 68-20-15b and 21 C.F.R. 1301.76(b)

Either the pharmacist in charge (PIC) or the pharmacy owner shall notify the Board in writing within one day of any suspected diversion, theft, or loss of any controlled substance and, upon completion, shall provide the Board with a copy of the completed DEA Form 106.

• K.A.R. 68-20-15b

A Virtual Manufacturer is an entity that engages in the manufacture of drug or device products for which it:

• Owns the NDA or ANDA number, if a prescription drug;
• Owns the UDI number, as available, for a prescription device;
• Contracts with a contract manufacturing organization for the physical manufacture of the drug or device product;
• Is not involved in the physical manufacture of the drug or device product; and
• At no time takes physical possession of, or stores, the drug or device product.

If the facility is only shipping products into Kansas that are manufactured at that specific facility into Kansas, register as a manufacturer.

If the facility is shipping products into Kansas manufactured at other facilities/locations, register as a distributor or a third party logistics provider (depending on whether or not the facility takes ownership).

1. A list of drug or device products it distributes;
2. A list of the NDA or ANDA numbers associated with each drug it distributes;
3. A list of the UDI numbers, as available, associated with each device it distributes;
4. The name and facility address of the contract manufacturer for each drug or device product it distributes;
5. Verification of current FDA registration for each contract manufacturing facility listed;
6. If the contract manufacturer distributes into Kansas, the wholesale distributor permit number for the contract manufacturer;
7. If the contract manufacturer does not distribute into Kansas, the name and Kansas wholesale distributor registration number for the entity that physically distributes the product into this State