Embecta is a new fully disposable insulin patch pump for patients with Type 1 and Type 2 Diabetes. This patch pump has a larger reservoir holding 300 units of insulin allowing for extended use for up to 3 days to better accommodate higher insulin needs as seen with Type 2 Diabetes. The pump patch also is great for individuals who are doing multiple daily injections to manage their diabetes therefore improving compliance and convenience for individuals.
Bezisterim is an investigation drug being studied for "potential ability to reduce the neurological symptoms associated with long Covid” Though there is not exact definition of what "long Covid" is, common symptoms are extreme fatigue, brain fog, light headedness, dizziness, and loss of taste and smell. Bezasterim is being investigated for Alzheimer’s and Parkinsons Disease since results showed patients experienced improved cognition and biomarker levels in Alzheimer’s disease. This drug can potentially be an added benefit in LTC if it shows meaningful improvement in motor control and cognition.
Novavax just received Emergency use authorization from the FDA for its new 2024-25 formula of the Covid-19 vaccine. Novavax is different from the other MRNA technology-based vaccines, as this on is protein based and targets the JN.1 strain but effectively covers the KP strains. Authorization of the updated Novavax, gives an additional option of another Covid-19 vaccine meeting FDA standards.
Neffy is the first ever needle-free Epinephrine Nasal spray that received approval from the FDA. Neffy is approved for type 1 allergic reactions, including anaphylaxis in adults and pediatrics that weigh over 66 pounds. This is a breakthrough treatment because up until now EpiPen/epinephrine has only been available as an injectable and can be challenging to self- administer for some individuals who fear needles that are going through an anaphylactic reaction. That delay in administering a needle can be life threatening with anaphylaxis. Neffy will be a safe and accessible therapeutic option and is easy to carry/store - beneficial to the long-term care and community.
References:
https://www.drugtopics.com/fda-updates
September 2024
All nursing homes that participate in the Medicare program must go through an annual recertification inspection, known as standard survey. These surprise visits conducted by the State can last days and is an intense process. Covid-19 and other factors resulted in state surveyors falling months to years behind on the annual survey process. Delayed surveys affect the CMS compliance and five - star quality rating of a nursing home as well and cause some facilities to fall out of compliance due to lack of consistent surveys. CMS finally decided to pilot a new "risk- based survey" as of April 2024. The goal is to use a more focused survey that will take less time for facilities that were consistently "higher- quality". The goal is that shorter quality surveys for these facilities will free up the time and resources for the higher-risk nursing homes and help all facilities to be up to date with annual surveys and their CMS ratings. "Higher quality nursing homes" are considered those that had few to no citations of non-compliance, better higher staffing, and fewer hospitalizations as well as other characteristics related to resident harm, abuse, investigations etc. If this survey pilot is successful, it will be the first change in the survey process in a long time and a potential benefit for all.
Embecta is a new fully disposable insulin patch pump for patients with Type 1 and Type 2 Diabetes. This patch pump has a larger reservoir holding 300 units of insulin allowing for extended use for up to 3 days to better accommodate higher insulin needs as seen with Type 2 Diabetes. The pump patch also is great for individuals who are doing multiple daily injections to manage their diabetes therefore improving compliance and convenience for individuals.
Bezisterim is an investigation drug being studied for "potential ability to reduce the neurological symptoms associated with long Covid” Though there is not exact definition of what "long Covid" is, common symptoms are extreme fatigue, brain fog, light headedness, dizziness, and loss of taste and smell. Bezasterim is being investigated for Alzheimer’s and Parkinsons Disease since results showed patients experienced improved cognition and biomarker levels in Alzheimer’s disease. This drug can potentially be an added benefit in LTC if it shows meaningful improvement in motor control and cognition.
Novavax just received Emergency use authorization from the FDA for its new 2024-25 formula of the Covid-19 vaccine. Novavax is different from the other MRNA technology-based vaccines, as this on is protein based and targets the JN.1 strain but effectively covers the KP strains. Authorization of the updated Novavax, gives an additional option of another Covid-19 vaccine meeting FDA standards.
Neffy is the first ever needle-free Epinephrine Nasal spray that received approval from the FDA. Neffy is approved for type 1 allergic reactions, including anaphylaxis in adults and pediatrics that weigh over 66 pounds. This is a breakthrough treatment because up until now EpiPen/epinephrine has only been available as an injectable and can be challenging to self- administer for some individuals who fear needles that are going through an anaphylactic reaction. That delay in administering a needle can be life threatening with anaphylaxis. Neffy will be a safe and accessible therapeutic option and is easy to carry/store - beneficial to the long-term care and community.
References:
https://www.drugtopics.com/fda-updates
September 2024
All nursing homes that participate in the Medicare program must go through an annual recertification inspection, known as standard survey. These surprise visits conducted by the State can last days and is an intense process. Covid-19 and other factors resulted in state surveyors falling months to years behind on the annual survey process. Delayed surveys affect the CMS compliance and five - star quality rating of a nursing home as well and cause some facilities to fall out of compliance due to lack of consistent surveys. CMS finally decided to pilot a new "risk- based survey" as of April 2024. The goal is to use a more focused survey that will take less time for facilities that were consistently "higher- quality". The goal is that shorter quality surveys for these facilities will free up the time and resources for the higher-risk nursing homes and help all facilities to be up to date with annual surveys and their CMS ratings. "Higher quality nursing homes" are considered those that had few to no citations of non-compliance, better higher staffing, and fewer hospitalizations as well as other characteristics related to resident harm, abuse, investigations etc. If this survey pilot is successful, it will be the first change in the survey process in a long time and a potential benefit for all.
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.
Final Rule CMS 3442-Final
The minimum staffing standards final ruling was confirmed on April 22, 2024, thereby holding nursing homes accountable for staffing to provide safe and quality care for residents living in such facilities. This final rule has new comprehensive minimum nurse staffing requirements with the goal to reduce risks to residents, reduce medication errors, and improve on quality care. The ruling and implementation is outlined below:
During the first quarter of 2024 alone there have been over 320 drug shortages, a ten-year record high. Most of these shortages are older generic products, with half being injectable medications. The generic medications can only compete with pricing, so likely a supply vs demand issue played a role in these shortages. The generic shortages do not affect the drug companies, because the cost to produce these medications is so low which is why there is not real drive to address the shortages quickly.
Many clinics and hospitals are completely out of certain medications causing disruptions in patient care. The FDA is looking at different tools that can be utilized to increase supply, including an expedited review of a supplement. Many of the shortages began years ago but were exacerbated by COVID-19 and we are now seeing the effects of the pandemic on supply. HHS will be looking at wholesalers and drug purchasing to identify disruptions in the supply chain.They are seeing how corporate control of drugs affects the end user, the patient.
