Kansas Regulations
Board of Pharmacy

COVID-19 Information

The Board office will be closed from March 21 – April 5, 2020.

The Kansas Board of Pharmacy has received numerous calls regarding COVID-19 and the impact it may cause on pharmacy services. To manage the volume of inquiries, the Board respectfully requests that licensees and registrants send questions to the Board via email. Direct inspector contact information is available here on by visiting the Board website. The Board website will be updated with new information Updates and recommendations as needed.

The Kansas Department of Health and Environment has a COVID-19 Resource Center on their website that may be accessed at: http://www.kdheks.gov/coronavirus. Their website allows consumers to subscribe to updates and provides links to frequently asked questions and CDC coronavirus information. They have also extended their phone hours: Monday-Friday 8am-7pm, Saturday 10am-2pm, and Sunday from 1pm-5pm.

KDHE ‘s number is:

1-866-534-3463 (1-866-KDHEINF)

Other information may be found at:

CDC https://www.cdc.gov/coronavirus/2019-ncov/hcp/index.html

DEA https://www.deadiversion.usdoj.gov/coronavirus.html

BOARD OPERATIONS

The Board office will be open and operational until 3:00pm March 20, 2020. To enforce social distancing requirements, the office is temporarily closed to walk-in customers. The Board will still receive drop-off, mail, email, and fax correspondence. Though we will be closed temporarily, long-term changes to service offerings, applications, renewals, or license/registration timelines are not anticipated at this time. However, the Board will continue to assess the COVID-19 situation in conjunction with the State of Kansas.

BEST PRACTICE RECOMMENDATIONS

To minimize contact and spread of COVID-19, the Board recommends pharmacies encourage customers to utilize drive-throughs where they are available. The Board also recommends requesting customers space themselves out when waiting in line and that the pharmacy consider the use of some sort of counter extension to establish a larger gap between the customer and the cashier, where possible.

CLEANING AND DETECTION

Pharmacists should use their professional judgment to ensure policies and procedures are in place to protect Kansas patients. The Board also recommends the following:

A. As always, pharmacy services must be safely and properly provided at all times. Pharmacies should take proactive steps to prevent the spread of germs and to protect Kansas patients. Proper cleaning, sanitizing, and disinfection procedures must be in place. See CDC’s guidance for keeping the workplace safe. https://www.cdc.gov/coronavirus/2019-ncov/downloads/workplace-school-and-home- guidance.pdf

B. The United States Environmental Protection Agency (EPA) has published an online listing of disinfectant products approved for use against SARS-COV-2, the coronavirus that causes COVID-19. The EPA list and other EPA virus related information is available online at https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2.

C. Pharmacy staff should be trained on how to recognize symptoms of potential illness and what to do if they develop symptoms or come in close contact with a person known to have COVID- 19. See the materials from KDHE and CDC as listed above.

D. The Board recommends establishing procedures for staff to report potential symptoms or COVID-19 exposure to pharmacy management/the pharmacist-in-charge. Pharmacy management should be trained on appropriate response measures, including any quarantine requirements. The CDC recommends that workers stay home if they are feeling sick or have a sick family member in their home.

E. Make sure pharmacy staff are trained on and use proper handwashing techniques. CDC handwashing recommendations are available online at: https://www.cdc.gov/coronavirus/2019- ncov/about/prevention.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus %2F2019-ncov%2Fabout%2Fprevention-treatment.html

A free CDC handwashing video is also available online at: https://www.youtube.com/watch?v=d914EnpU4Fo.

TEMPORARY PHARMACY CLOSURE

The Board recognizes that situations could occur that may require the pharmacy to temporarily close. Planning is key! The Board encourages licensees to take proactive steps to adopt emergency response plans before an actual emergency occurs. In the event a pharmacy has to temporarily close, licensees should take proactive steps to assist patients and avoid interruptions in patient care: A. Provide patients as much advance notification as possible. The Board recommends posting signs/notifications in a publicly visible location such as on main entry doors, near the pharmacy area, and on the pharmacy’s website. Other direct patient notification options should also be considered (e.g., HIPAA compliant texts/e-mails).

B. Patients should be provided instructions and contact information for contacting the pharmacy/speaking with a pharmacist (phone number/e-mail). To avoid medication interruptions, the Board recommends providing directions for transferring prescriptions, if necessary.

C. Notify the Board by email if the pharmacy must temporarily close (more than one day) due to COVID-19 and provide follow-up email notification when the pharmacy reopens.

D. Remote – Kansas does not have any regulation that would allow a pharmacist not licensed by Kansas or not working for a Kansas-registered nonresident pharmacy to provide remote services to a pharmacy in Kansas.

Kansas law does not allow for technicians to work from home.

REUSE OF GARB FOR STERILE COMPOUNDING PHARMACIES

Licensees have expressed concerns with potential shortages of gowns, face masks, and shoe covers. The Board recommends talking with your supplier. If a shortage is anticipated, pharmacies should first consider measures to conserve supplies they have on hand. Potential measures could include limiting the number of personnel entering the buffer room/controlled area and modifying staging activities to minimize trips into the buffer room/controlled area.

The Board recommends watching the CriticalPoint® webinar “COVID-19: Downstream Implications for Sterile Compounding” available on their website:

https://www.criticalpoint.info/

The Board has approved the reuse of masks per CriticalPoint® suggestion. Please make sure to update policy and procedures and to train staff if there are any changes to current practices.

Note: CriticalPoint® information is being provided for informational purposes only.

The webinar was conducted by a private entity and is not officially endorsed or sponsored by the Board. Recommendations/suggestions are solely those of CriticalPoint® and do not necessarily represent the opinions/recommendations of the State of Kansas. In the event of a conflict, Kansas law will apply.

This is a temporary allowance due to shortages resulting from COVID-19.

Reassessment will be April 13th.

EMERGENCY REFILLS

As a reminder, emergency refills are addressed in K.S.A. 65-1637(k)(2) which states:

“A pharmacist may refill a prescription order issued on or after the effective date of this act for any prescription drug, except a drug listed on schedule II of the uniform controlled substances act or a narcotic drug listed on any schedule of the uniform controlled substances act, without the prescriber’s authorization when all reasonable efforts to contact the prescriber have failed and when, in the pharmacist’s professional judgment, continuation of the medication is necessary for the patient’s health, safety and welfare. Such prescription refill shall only be in an amount judged by the pharmacist to be sufficient to maintain the patient until the prescriber can be contacted, but in no event shall a refill under this paragraph be more than a seven-day supply or one package of the drug. However, if the prescriber states on a prescription that there shall be no emergency refilling of that prescription, then the pharmacist shall not dispense any emergency medication pursuant to that prescription. A pharmacist who refills a prescription order under this paragraph shall contact the prescriber of the prescription order on the next business day subsequent to the refill or as soon thereafter as possible. No pharmacist shall be required to refill any prescription order under this paragraph. A prescriber shall not be subject to liability for any damages resulting from the refilling of a prescription order by a pharmacist under this paragraph unless such damages are occasioned by the gross negligence or willful or wanton acts or omissions by the prescriber.”

NEW FDA GUIDANCE

The FDA has published guidance on the temporary compounding of hand sanitizer by pharmacies and outsourcing facilities during this emergency period. This guidance can be found at https://www.fda.gov/media/136118/download. During the emergency period, the Board will allow over-the-counter compounding of hand sanitizer without a prescription only when the FDA guidance document, including the information regarding formulation and labeling, is being followed exactly. This allowance is in effect until rescinded by the Board as published and noticed on the Board website. The Board does expect all applicable compounding documentation to be maintained in accordance with Kansas compounding regulations for any hand sanitizer products made by registered facilities during this time.

The FDA has also issued a letter to healthcare providers on surgical mask and gown conservation strategies. This letter can be read by clicking here.

BOARD RENEWALS

The Board plans to proceed with the regular renewal schedule for all licenses and registrations expiring June 30, 2020. Renewals will open on or around May 15. Once approved, facilities will be expected to print the renewed registration through the online portal – they will NOT be mailed. A renewed pharmacist license will still be mailed to the address of record.

Updated information related to the new requirements and categorizations to comply with the DSCSA and K.A.R. 68-14-1 through K.A.R. 68-14-7b will be released soon.

ASHP RESOURCES

ASHP is making its resources available to pharmacists for free for the next 60 days by unlocking resources on ASHP.org including section and topical Resource Centers (e.g., Emergency Preparedness, Geriatrics, Inpatient Care), relevant webinars and online programs (e.g., infectious diseases, flu, disaster and mass casualty preparedness, and well-being and resilience), and select AJHP articles. Additionally, public access to AHFS Drug Information is available for the next 60 days with the username "ahfs@ashp.org" and password "covid-19."

COVID-19 Resource Center

REMOTE WORK

The Board has made the decision to temporarily allow remote work by pharmacy employees. This allowance only applies to pharmacies physically located in Kansas and persons licensed or registered with the Board. This allowance is only in effect until rescinded by the Board as published and noticed on the Board website. The Board guidelines for remote work are as follows:

Pharmacies:

• Remote workers must have secure, electronic access to the pharmacy prescription processing software.

• Any technology used must meet HIPAA compliance standards. The Board also expects HIPAA safeguards to be in place at the location of remote work so that non-employee persons present at the location are not able to see or have access to patient information.

• The Board will not offer guidance as to whether a pharmacy’s established processes meet federally-required security and privacy standards.

• The pharmacy must maintain a document (for 5 years) at the pharmacy that includes: o A list of all employees working remotely which shall include:

• Name and license/registration/permit number of the employee

• Address where the employee will be located when performing the remote activities

• Phone number where the employee can be reached when performing the remote activities

o The date range that the pharmacy conducted remote work activities

• All remote activities must be able to meet Kansas requirements for recordkeeping and documentation including, but not limited to, tracking the specific personnel who performed various steps in the dispensing process.

• All physical dispensing activities (tablet counting, packaging, labeling, compounding, etc.) and final product review must occur on-site at the pharmacy.

• Nothing in this guidance is intended to allow a pharmacy to be open without a pharmacist physically present at the pharmacy. See K.S.A. 65-1637c.

Pharmacists:

• The pharmacist must be licensed in Kansas.

• Any supervision of technicians, including those working remotely, must be conducted by a pharmacist physically located at the pharmacy. A pharmacist working remotely may not supervise a technician.

• The 4:1 technician to pharmacist ratio is still in effect and includes any technician working remotely. See updated K.A.R. 68-5-16, effective February 7, 2020.

Technicians:

• Only grandfathered technicians and technicians that have passed an approved national certification exam may work remotely. This includes technicians with 14- prefixes to their registration number. Technicians with 24- prefixes to their registration number are not allowed to work remotely.

• Technicians may only work remotely during the pharmacy’s regular business hours.

• Technicians may perform the following tasks when working remotely:

o Data Entry

o Refill queue processing

o Sending refill requests to prescribers by automated methods o Insurance Processing

o Contacting patients for clarification of personal data and insurance processing information (i.e., date of birth, insurance information, etc.)

•Please note: Patients may be unwilling to provide personal information to a person calling from a phone number unrelated to the pharmacy. Please do not be forceful with patients in these situations and have the technician contact the pharmacy to call the patient directly.

• While working remotely, technicians may not:

o Directly contact prescribers or prescriber offices for clarifications or refills o Directly contact patients for issues related to medication therapy.

o Please note: This list is not exhaustive and the supervising pharmacist should rely on the aforementioned list of approved activities to direct technicians.

• Any technician working remotely must maintain direct communication capabilities with the supervising pharmacist (located at the pharmacy) at all times. A video component is not required.

For interns:

• Interns may only work remotely to perform technician functions and are expected to follow the guidelines for technicians.

• Any hours spent working remotely to perform technician duties shall not count towards the intern hours required by the Board.