As we start off 2025, it is important to review any changes that will take place with regards to CMS surveys and other regulatory updates. The CMS has updated the survey guidance and revised the State Operations Manual that will be effective as of February 24, 2025. Surveyors will begin using the new guidance for all surveys as of the above effective date. The goal is to streamline the survey process and eliminate overlapping citations. The following are some of the guidances that have been revised. Your team should review and ensure that changes in your processes have been made to maintain compliance with new standards.
High-alert medications are those with a high risk of causing significant harm if used incorrectly. They often have narrow therapeutic indices, complex dosing requirements, and similar names or packaging to other drugs.
Common examples include:
Prevention strategies include robust error identification, limiting access to these medications, staff and patient education, and ensuring rapid access to antidotes or reversal agents in case of errors. Vigilance and adherence to protocols are essential to mitigate risks associated with these medications.
May 6th was World Asthma Day, and SpecialtyRx is here to give you all the latest updates around Asthma guidelines!
The Global Asthma Initiative (GINA) has updated its guidelines for 2025. Some ofthe key changes include looking at additional biomarkers for Type 2 inflammation,additional risk factors for severe exacerbation in adults, including environmentalfactors and air quality that they are exposed to, and the impact of extreme weather.The diagnosis criteria have also been updated for clarity because variability insymptoms and expiratory airflow are two distinct characteristics of Asthma.Additionally, a reference to a calculator of peak expiratory flow variability was alsoadded.
Treatment recommendations for adults are in two treatment tracks for better clarity,and due to poor access to some preferred combination inhaled products. The mainkey difference is the medication that is used for symptom relief. Track one maintainsan"as needed" inhaled corticosteroid (ICS) - formoterol combination product such asSymbicort or Dulera as the preferred treatment approach. Formoterol substantiallyreduces the risk of severe exacerbations and systemic corticosteroid exposure ascompared to short-acting beta agonists (SABA) based regimens. Also, thecombination products provide a simpler regimen and better overall compliance.
Track 2 uses the alternative approach of “as needed” SABA or as needed ICS-SABA(ie, Airsupra -combo product or albuterol and a steroid inhaler separately), which maybe a good option for patients with controlled stable asthma and no exacerbations. Itis recommended to ensure the patient is good with medication adherence beforeusing one of these suggested products.
The U.S. Department of Veterans Affairs (VA) and Department of Defense alsoreleased updated clinical practice guidelines for Asthma in March 2025. Like the GINAguidelines, the VA also makes strong recommendations for the use of ICS incombination with a long-acting beta agonist (LABA) such as formoterol as both acontroller and reliever for those with uncontrolled asthma.
Lastly, the latest studies show that the use of Proton Pump Inhibitors (PPI) has beenassociated with increased asthma incidence. While PPIs are used to manage GERD,which itself can also worsen symptoms of asthma, the use of PPIs may not be thebest option in asthma patients. If there are residents who are on PPIs and seem tocontinue having asthma that is uncontrolled, consider switching to an H2-receptorantagonist such as famotidine or ranitidine.
Asthma is a chronic condition that can affect many residents in the nursing homesetting. Proper management by identifying triggers, educating residents and staff,and having up-to-date knowledge of new and preferred treatment options can begreatly beneficial in better controlling and reducing asthma exacerbations in theelderly.
On June 5, 2024, the Vaccines and Related Biological Products Advisory Committee (VRBAC) and FDA panel met and unanimously voted for the JN.1 strain for the new fall 2024-25 COVID-19 vaccine formulation. A week later, based on updated data, the FDA asked the vaccine manufacturers to focus on the KP.2 and KP.3 strains of the JN.1 lineage as they are becoming the more dominant strains. It is anticipated that the change requested by the FDA will not cause any delays in the manufacturing of the new formulations.
The vaccine manufacturers (Pfizer, Moderna) expect the new vaccine will be available mid to late August, while Novavax anticipates a slightly later release in September but still in time to begin the fall vaccine administrations once the final approval is received by the FDA. The current COVID-19 2023-24 vaccine is still approved for administration, likely for the remainder of the summer, however, production of the 2023-24 formulation has stopped as manufacturers gear for the new formulation.
Currently, Pfizer has stopped shipping all 2023-24 from Pfizer direct. Going forward, additional doses of Pfizer and Moderna may be obtained through regular wholesalers or vendors IF they have any more stock remaining. Once the 2023-24 is completely depleted from all Vendors, facilities should wait until the new formulation is available early fall.
Facilities are encouraged to review all patients who did not receive any vaccine or dose of the 2023-24 formula and administer it as a priority for those patients. For all others who have already received at least one dose of the 2023-24 formula in recent months, it may be beneficial to wait for the new formulation at the discretion of the healthcare provider and facility protocol.
The ACIP and CDC advisory group made official recommendations on June 27, 2024, for who should get the new vaccine in the fall. They continue to support vaccination against Covid-19 with one dose of the new 2024-25 formulation in all individuals ages 6 months and older irrespective of whether they were previously vaccinated for COVID-19.
