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  • 08/03/2021 9:09 AM | Anonymous member (Administrator)

    By Don R. McGuire Jr., R.Ph., J.D.
    Pharmacists Mutual Insurance Company

    As a young pharmacist, I experienced my first recall when the drug Oraflex (benoxaprofen) was taken off the market in 1982. The drug was effective in treating arthritis, but had some serious side effects. What I remember were patients telling us this was the only drug that worked for them and asking us to sell it to them rather than returning the drug to the manufacturer. Ultimately, we decided to send it back to the manufacturer. The recent recall of ranitidine and other products for nitrosamine impurities caused me to reflect on how little I understood recalls in 1982.

    Drug recalls are voluntary actions taken by a manufacturer to remove a defective product from the marketplace. A recall can be initiated by the manufacturer or the Food and Drug Administration (FDA) can request a recall. Recalls are almost always voluntary by the manufacturer and FDA rarely requests a recall. FDA's role in a drug recall is the same as in the recall of other FDA regulated products; e.g. medical devices, cosmetics, food, etc. The agency's role is to classify the recall, to oversee the manufacturer's strategy, and assess the adequacy of the recall.

    Recalls are classified by their severity. Class I recalls involve a dangerous or defective product that could cause serious health problems or death. Class II recalls involve products that could cause a temporary health problem or a slight threat of serious harm. Products involved in Class III recalls are unlikely to cause adverse health reactions, but the products violate labeling or manufacturing laws. You will not hear about every recall on the news. Public notification of a recall usually occurs when the product has been widely distributed or poses a serious health hazard, such as in a Class I recall. However, all recalls are posted weekly on the FDA website through their Enforcement Reports page.

    You can also register to receive email notifications of new and updated recalls. Familiarizing yourself with current recalls will be beneficial when your patients contact you with a question about a recall. FDA recommends patients talk to their pharmacists about recalled medications. Class I recalls generally provide information specifically for patients, but other Class recalls do not. Being informed about current recalls will assist you in helping your patients get replacement therapies.

    The ranitidine recall applied to both prescription and over-the-counter (OTC) versions of the drug. The recall notice advised patients to stop taking OTC ranitidine immediately, but to consult with their health care professional about other treatment options before discontinuing prescription ranitidine. These types of instruction will generate questions from your patients. Besides being aware of the recommendations for your patients, the recall notice will advise the pharmacy on the removal of the drug from stock and the return procedures.

    From a liability perspective, you should follow the procedures outlined in the recall notice. Remove items from stock as instructed. Some recalls will advise you to contact patients currently taking a prescription product. Verify that you have or had the affected lots and notify your patients who received the affected lots as soon as practical. Keeping your computer system updated with current lot numbers and expiration dates of prescription products is crucial to being able to identify those who have received the recalled product. If you receive a new prescription after the recall notice, use the opportunity to help educate prescribers in your area. Be ready to suggest alternatives that are not affected by the recall. Needless to say, it is not a good idea to sell or dispense recalled products at the patient's request instead of following the return process in the recall notice. Another bad idea is compounding the recalled medication when the manufactured product isn't available due to a recall.

    Rather than being a passive recipient of information, going online to regularly review recall notices will allow you to be proactive with you patients' therapies. Your patients will see you as a trusted partner in their healthcare. Follow the recall procedures, make sound professional judgments when necessary, and your patients will value your services even more.

    ©Don R. McGuire Jr., R.Ph., J.D., is General Counsel, Senior Vice President, Risk Management & Compliance at Pharmacists Mutual Insurance Company.

    This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with policies and procedures of their employers and insurance companies, and act accordingly.

  • 07/21/2021 6:59 AM | Anonymous member (Administrator)

    Don't miss out on discounted rates for the 2021 KPhA Annual Meeting and Trade Show! Early Bird pricing ends July 31. Standard rates run through the end of August.

    The Kansas Pharmacists Association will RECONNECT Sept. 24-26 in Dodge City for a three-day IN-PERSON event with fellow KPhA members from across the state and network with industry professionals and the next generation of pharmacy leaders.

    What can you expect?

    9.24 // Get back into the swing of things on Friday morning with the Kansas Pharmacy Foundation Golf Tournament. If golf isn't your thing, enjoy an art class at the Carnegie Center for the arts and lunch in downtown Dodge City before taking in the history of the area. That evening, connect with industry-leading professionals during the trade show and dinner.

    9.25 // The education program covers two full days of learning and features speakers from APhA and NCPA, as well as topics ranging from telepharmacy, profit-building strategies, and CBD to antibiotic resistance, genomics, and much more! See a variety show performance before we take an after-hours tour the newly renovated Boot Hill Museum.

    9.26 // Don't miss the annual pharmacy law update from the Kansas Board of Pharmacy. The Annual Meeting and Awards Banquet highlights the day as we pay tribute to deserving Kansas pharmacy leaders. The Self Care Challenge also makes its return with the ever popular students vs. pharmacists OTC trivia competition.

    Don't wait -- register today!

  • 07/21/2021 6:49 AM | Anonymous member (Administrator)

    As essential businesses on the front lines, pharmacies have continued to demonstrate their value during the pandemic by remaining open to the community for vital prescription services, evolving into COVID-19 point-of-care testing sites, and becoming COVID-19 vaccine administration sites. Pharmacies are essential in achieving the end goal of herd immunity2 in the global battle against SARS-CoV-2, the virus that causes COVID-19.

    Now pharmacies will have the opportunity to take the lessons learned during the COVID-19 vaccination rollout to prepare for the 2021-2022 influenza season.

    Continue reading at Pharmacy Times.

  • 07/14/2021 4:38 PM | Anonymous member (Administrator)

    By Trenton Thiede, PharmD, MBA
    President, PAAS National®

    When processing a prescription, the pharmacy is required to assign an origin code to the claim. PAAS National® continues to see audit results for invalid origin codes. These discrepancies can range from $5 fees to full recoupments. The proper use of the origin code field is to record how the pharmacy originally received the prescription order from the prescriber. Below are two of the most common questions PAAS receives related to origin codes.

    1. Does the origin code change if you need to call the prescriber to clarify a prescription and make a clinical note?

    Answer: No, NCPDP states that any clarifications or modifications to the original prescription [after receiving it at the pharmacy] do not change the origin code. The origin codes stays the same throughout the life of that prescription.

    2. What origin code is used for a standing order or protocol?

    Answer: Origin code 5 – Pharmacy (some software systems label as Transfer instead of Pharmacy). A standing order or protocol would be designated as origin code 5 because it is being created by the pharmacy. Two examples of a standing order or protocol commonly used are for administering immunizations and dispensing Narcan.

    Here are the NCPDP Definitions:
    0 – Not Known
    1 – Written – Prescription obtained via paper.
    2 – Telephone – Prescription obtained via oral instructions or interactive voice response using a phone.
    3 – Electronic – Prescription obtained via SCRIPT or HL7 Standard transactions, or electronically within closed systems.
    4 – Facsimile – Prescription obtained via transmission using a fax machine.
    5 – Pharmacy – This value is used to cover any situations where a new Rx number needs to be created from an existing valid prescription such as traditional transfers, intrachain transfers, file buys, software upgrades/migrations, and any reason necessary to “give it a new number.” This value is also the appropriate value for “Pharmacy Dispensing” when applicable such as behind the counter (BTC), Plan B, established protocols, pharmacist’s authority to prescriber, etc.

    You can find a link to the NCPDP February 2021, Telecommunication Version D and Above Questions, Answers and Editorial Updates document here: ncpdp.org/NCPDP/media/pdf/VersionD-Questions.pdf (see section 3.1.4 on origin codes).

    PAAS National® is an expert third-party audit assistance and FWA/HIPAA compliance organization. It is committed to serving community pharmacies and helping keep hard-earned money where it belongs. Learn more at paasnational.com or email info@paasnational.com to see why membership might be right for you.

    ©2021 PAAS National® LLC All Rights Reserved

  • 06/28/2021 12:17 PM | Anonymous member (Administrator)

    The Centers for Disease Control and Prevention (CDC) has identified that the combined frequencies of the SARS-CoV-2 P.1/Gamma variant (first identified in Brazil) and the B.1.351/Beta variant (first identified in South Africa) throughout the United States exceed 11% and are trending upward (https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html).

    Data suggests that bamlanivimab and etesevimab together are not active against either the P.1 (Gamma) or B.1.351 (Beta) variants, while other authorized monoclonal antibody therapies are expected to retain activity to this variant. Antiviral resistance information for bamlanivimab and etesevimab together can be found in Section 15 of the authorized Fact Sheet for Healthcare Providers. The FDA recommends that healthcare providers use alternative authorized monoclonal antibody therapies until further notice, and the Assistant Secretary for Preparedness and Response (ASPR) will temporarily stop shipping bamlanivimab and etesevimab together, and etesevimab alone to pair with existing bamlanivimab. You can read the Dear HCP Letter, or get more information on this and other updates here.

    For additional information, contact the Lilly COVID Hotline at 1-855-545-5921 or visit LillyAntibody.com.

    Authorized Use
    Bamlanivimab and etesevimab are authorized to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

    • Bamlanivimab and etesevimab together have not been approved, but have been authorized for emergency use by the FDA.
    • Bamlanivimab and etesevimab together are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab and etesevimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

    Limitations of Authorized Use

    • Bamlanivimab and etesevimab together are not authorized for use in patients:
      • who are hospitalized due to COVID-19, OR
      • who require oxygen therapy due to COVID-19, OR
      • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
    • Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

    There are limited clinical data available for bamlanivimab and etesevimab. Serious and unexpected adverse events may occur that have not been previously reported with the use of bamlanivimab and etesevimab together.

    Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions
    Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of bamlanivimab with and without etesevimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy.

    Infusion-related reactions have been observed with administration of bamlanivimab and etesevimab together. These reactions may be severe or life threatening. Signs and symptoms of infusion-related reactions may include:

    • fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, and diaphoresis.

    If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.

    Clinical Worsening After Bamlanivimab Administration
    Clinical worsening of COVID-19 after administration of bamlanivimab has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19.

    Limitations of Benefit and Potential Risk in Patients with Severe COVID-19
    Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. See Limitations of Authorized Use.

    Adverse Reactions
    Adverse reactions observed in those who have received bamlanivimab and etesevimab are anaphylaxis (n=1, 0.07%) and infusion-related reactions (n=16, 1.1%). The most common treatment-emergent adverse events included nausea, dizziness, and pruritis. No treatment-emergent events occurred in more than 1% of participants and rates were comparable to placebo.

    There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bamlanivimab and etesevimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

    There are no available data on the presence of bamlanivimab or etesevimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

    Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bamlanivimab and etesevimab and mandatory requirements of the EUA. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bamlanivimab and etesevimab.

  • 06/08/2021 11:47 AM | Anonymous member (Administrator)

    Kansas Tobacco Cessation Help is a free, newly revised tobacco cessation online training. It is a self-paced course that guides you through seven modules, each ranging from 15-30 minutes. The modules cover enhanced Quitline services, Kansas Medicaid cessation benefits, vaping, teen tobacco use, behavioral health, and Quitline counseling call samples. To review a summary of each module or register for the training, please visit https://quitlogixeducation.org/kansas.

  • 06/07/2021 1:33 PM | Anonymous member (Administrator)

    On May 26, the 2021 legislative session came to its ceremonial end as the House and Senate adjourned Sine Die. The full legislature will not return until Jan. 10 of next year to convene its 2022 session. This was an unprecedented session in many ways, from COVID-19 challenges to the passage of a constitutional amendment, tax and election reforms, and the first-ever medical cannabis bill to pass out of committee and across the House floor with bipartisan support.

    Enacted Legislation - Many bills were signed by the Governor, while several were vetoed and some overridden by the required two-thirds majority vote in each chamber. Of a majority of the bills she signed into law, Gov. Kelly said: “This is the kind of success that can be achieved when we work together – not as Republicans or Democrats – but as Kansans. I want to thank my colleagues in the legislature, on both sides of the aisle, for their efforts.”

    Below are some of the more notable bills either approved by the Governor, bills that became law without her signature, and those bills that were vetoed and overridden, becoming law without her approval.


    • SB13 - Property tax reform, including county tax lid discontinuance and establishing the taxpayer notification costs fund
    • SB14 - Extending certain provisions of the governmental response to the COVID-19 pandemic in Kansas and providing certain relief related to health, welfare, property and economic security
    • SB60 - Creating the crime of sexual extortion and requiring an offender to register under the Kansas offender registration act, other increased criminal penalties
    • SB88 - Establishing the city utility low-interest loan program following the extreme weather event of February 2021
    • SB170 - Enacting the physical therapy licensure compact, other healthcare measures
    • SB283 - Continuing the governmental response to the COVID-19 pandemic in Kansas by extending the expanded use of telemedicine and granting of certain temporary emergency licenses
    • HB2064 - Creating the Kansas promise scholarship act
    • HB2066 - Expanding the military spouse and service members expedited licensure law to all applicants who have established or intend to establish residency in Kansas
    • HB2085 - Creating the students' right to know act to provide information on postsecondary education options
    • HB2134 - Making appropriations for the Kansas state department of education for FY 2021-2023, amending at-risk definitions, extending high-density at-risk weighting, and other provisions for schools
    • HB2187 - Enacting the first-time home buyer savings account act
    • HB2196 - Unemployment system modernization, creating the unemployment compensation modernization and improvement council, development of a new unemployment insurance information technology system, and other provisions
    • HB2208 - Enacting the rural emergency hospital act to provide for the licensure of rural emergency hospitals
    • HB2379 - Enacting the peer-to-peer vehicle sharing act

    Vetoed and Overridden:

    • SB50 - Tax reform, requiring marketplace facilitators to collect and remit sales, providing for addition and subtraction modifications for the treatment of global intangible low-taxed income, expanding the expense deduction for income taxpayers and calculating the deduction amount, providing the ability to elect to itemize for individuals, other provisions
    • HB2058 - Providing reciprocity for licenses to carry concealed handguns and creating a new class of concealed carry license for individuals 18 to 20 years of age, and creating the Kansas protection of firearm rights act to restore the right to possess a firearm upon expungement of certain convictions
    • HB2183 - Election reforms, creating the transparency in revenues underwriting elections act; prohibiting the receipt and expenditure of private moneys by election officials; directing the secretary of state to publish certain registered voter totals, limiting the number of such ballots that can be delivered, removing the secretary of state's authority to provide additional time for receipt of such ballots, creating the crime of false representation of an election official; and, expanding the crime of electioneering, other provisions
    • HB2332 - Further election reforms, prohibiting the modification of election laws other than by legislative process, requiring identification of the sender on third party solicitations to registered voters to file an application for an advance voting ballot and prohibiting such solicitations by nonresidents of this state, expanding the crime of election tampering and providing for the appointment of elected officials when vacancy is due to military service

    *Note: One veto override was attempted on Sine Die - SB 29 (providing for short-term, limited duration health plans). The two-thirds majority vote requirement was met in the Senate but fell short in the House, and the veto was sustained.


    1861 Consulting, on behalf of the Kansas Pharmacists Association, actively tracked 47 bills, and lobbied 13 bills on during the 2021 Session. The biggest wins from this session were the passage of the Telepharmacy and Modernization bill, the continued interest in prescription costs, and the hearing, conversations, and legislative support on a Point of Care Test and Treat bill. We will continue conversations with legislators and stakeholders over the interim on these issues to keep KPhA support and momentum going into the 2022 Legislative Session.

    Board of Pharmacy Authority, Telepharmacy (CCR SB 238 / HB 2280) - HB 2280 would amend the Board of Pharmacy's regulatory and investigative authority, allow for telepharmacy in Kansas, and a series of other technical updates including updating the definition of “dispense”. On April 8th a conference committee inserted the contents of HB 2280 into SB 238 without changes made in the Senate on off-label physician prescribing. On April 9th the House approved CCR SB 238 on a vote of 116-7 and on May 5th the Senate on a vote of 36-4. SB 238 was signed into law by Gov. Kelly on May 19th and will take effect upon publication in the Register.

    PBM Licensure, Enhanced Regulation (SB 244 / HB 2383) - SB 244 and HB 2383 would require licensure of pharmacy benefits managers and their enhanced regulation. Neither SB 244 nor HB 2383 were enacted during the 2021 Session and will carry over for the 2022 Session.

    Point of Care Test & Treat (SB 200 / HB 2385) - HB 2385 and SB 200 would allow a pharmacist to test and initiate therapy for a health condition that is generally managed with minimal treatment including, but not limited to: Influenza, streptococcus, COVID-19, pre-exposure prophylaxis, post-exposure prophylaxis, and other CLIA waived tests. SB 200 & HB 2385 are DEAD for the 2021 Session. Neither SB 200 nor HB 2385 were enacted during the 2021 Session and will carry over for the 2022 Session.

    Reimbursement for Pharmacist Services (HB 2388) - HB 2388 would require insurers that provide coverage of a professional service provided by a physician, APRN, or a PA also provide coverage for such services if lawfully provided by a pharmacist. HB 2388 was not enacted during the 2021 Session and will carry over for the 2022 Session.

    340B Amendment / Omnibus Budget (SB 159) - The Legislature included an interim review of the 340B program within HB 159. This 13-member LCC-appointed committee, with a Chair appointed by the Speaker of the House, will review federal law requirements; the role of qualifying 340B providers, pharmacies, PBMs and pharmaceutical drug manufacturers; the fiscal impact; federal or state law changes; marketplace developments; healthcare payers, including insureds, self-insureds and government programs. SB 159 was signed into law by Gov. Kelly on May 21st and will take effect upon publication in the Register.

    PBM Treatment of 340B Pharmacies (SB 128 / HB 2260) - SB 128 and HB 2260 would limit PBM’s from interfering with a covered person’s choice, under certain conditions requiring collection of a cost share, or disparate treatment of a pharmacy by requiring terms that differ from those imposed on another pharmacy based solely on such pharmacy's designation on a 340B covered entity. Neither SB 128 or HB 2260 were enacted during the 2021 Session and will carry over for the 2022 Session.

    Expedited Licensure (HB 2066) - HB 2066 expands the expedited licensure law currently in place for a military spouse and service member to all applicants who have established or intend to establish residence in Kansas. HB 2066 was signed into law by Gov. Kelly on April 21st and will take effect July 1, 2021.

  • 06/05/2021 1:40 PM | Anonymous member (Administrator)

    Early Bird Registration is open for the 2021 Annual Meeting and Trade Show in Dodge City with discounted pricing available through July 31.

    The weekend kicks off on Friday, Sept. 24, with the annual Kansas Pharmacy Foundation Golf Tournament at Dodge City Country Club. Check-in for the 4-person scramble begins at 8:30 a.m. and play begins at 9 a.m. If golf isn't your thing, you can check out Downtown Dodge City and take an art class at the Carnegie Center for the Arts. Attendees then will gather at United Wireless Arena that eventing for the trade show and dinner, where they'll also get a first look at items up for bid in the KPF Silent Auction.

    Fourteen classes are on tap for Saturday, with featured speaker Cory Jenks - an improv comedian and pharmacist - will teach you how going off script (pharmacy pun intended) is the secret to creating an incredible healthcare experience for patients and providers. His program will include a Lunch and Learn session on Improv 101. Sunday's educational offerings include a keynote from APhA President Scott Knoer on The Future of Pharmacy and Alexandra Blasi with a Board of Pharmacy Law Update.

    KPhA will once again be collecting travel- or trial-size personal care items to make a difference in our host city. Items will be donated to Manna House, a Dodge City shelter.

    Get a full run-down of the weekend and reserve your spot at https://kansaspharmacistsassociation.wildapricot.org/kpha2021.

  • 06/05/2021 11:34 AM | Anonymous member (Administrator)

    Kansas Board of Pharmacy

    In September and October 2020, some pharmacy technicians were approved for the technician certification extension through June 30, 2021. Registrations issued after July 1, 2017, require proof of completion of the national certification examination to the Board office. For those technicians granted a waiver, failure to provide proof by  June  30  will  result  in  the  technician’s  registration  being canceled.

    Please email pharmacy@ks.gov or fax 785-296-8420 a copy of the Pharmacy Technician Certification Board’s Pharmacy  Technician  Certification  Exam  (PTCE)  or  the  Exam for the Certification of Pharmacy Technicians (ExCPT) certificate. Individuals with expired certifications will not be able to reapply for registration as a pharmacy technician in Kansas until they have passed the certification exam. The Board has approved the PTCE and the National Health-career Association’s ExCPT.

    Any pharmacy technician who is unable to take or pass the PTCE or ExCPT by Oct. 31, 2021, may request a six-month extension  at  least  30  days  before  the  technician’s  registration  expiration  date  by  completing  a  Technician  Certification  Extension Request Form LA-75.

  • 06/03/2021 11:33 AM | Anonymous member (Administrator)

    The CEO of the country’s largest organization of community pharmacies today called for immediate action after the Centers for Medicare & Medicaid Services disclosed in a budget document that pharmacy benefit managers increased retroactive fees on pharmacies by an astonishing 91,500 percent in recent years.

    “This is absolutely unsustainable,” said B. Douglas Hoey, CEO of the National Community Pharmacists Association, which represents more than 21,000 independently owned pharmacies across the country.

    Read more at www.ncpa.org.

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