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Stay Alert | FDA Updates
Title of the regulatory update One
Stay Alert | FDA Updates
August 2025

Title of the regulatory update One

Covid-19 Updates
On March 1, 2024 the CDC updated their guidelines. An additional dose of the Covid-19 202324 vaccine has been approved for individuals over the age of 65. This dose can be administered 4 months after the previous dose.

The FDA issued a new Emergency Use Authorization (EUA) on March 22, 2024 for Pemgarda (pemivibart). This medication can be used for the prevention of Covid-19 as a pre-exposure prophylaxis treatment.

This is the first treatment to be used a “pre exposure medication” Pemgarda is for individuals over the after of 12 or at least weighing 40kg, who are not infected with the virus AND have not had recent exposure to Covid-19. It is only to be considered for individuals that are moderate to severe immune compromised where vaccine will likely not provide adequate immune response.


How statins reduce mortality

Statins are the first line treatment for cardiovascular disease-atherosclerosis, more simply put, the high cholesterol. However, since these medications also have known associated risks in the elderly, the effects of it in older patients with multiple comorbidities, including dementia was not available and it was broadly recommended to avoid statins.

Recently, after extensive review in this population, the use of statins has been associated with improved mortality in the elderly, including those with dementia
The take home message is that these medications might improve the quality of life by reducing the risk for cardiovascular events in the elderly including those with dementia and this is something to consider in the nursing home setting. Perhaps it is important to look at the bigger picture of the benefit these medications can provide before recommending to de-prescribe statins. 

Click here for full article

Updates to Asthma Management Guidelines
May 2025

Updates to Asthma Management Guidelines

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.

New COVID-19 Vaccine 2024-25 Formulation
August 2025

New COVID-19 Vaccine 2024-25 Formulation

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.

MedMemos: Medications That Need Glucose Monitoring
August 2025

MedMemos: Medications That Need Glucose Monitoring

One of the most common disease states in Long Term Care is Diabetes Mellitus Type 2. We always focus on obtaining glycemic control for these patients. However, often we forget that some of the most common classes of medications used to treat other disease states in diabetic patients, can disrupt the glucose levels. This may require extra monitoring of glucose levels or an adjustment of diabetic medications. Below are five commonly-used medication classes that should be reviewed when prescribing for your diabetic resident:

1. Glucocorticoids

Medications such as prednisone or methylprednisolone are some of the most commonly known offenders of affecting glycemic control in diabetics and even causing new onset diabetes or steroid induced diabetes. Management of glucose depends on duration of glucocorticoid therapy, and how well the patient’s glucose was controlled prior to initiating therapy.

Tips:

  • Metformin can help in managing glucose for short duration of glucocorticoid therapy.
  • Initiation of a short acting insulin or NPH might be the preferred option for patients
    with uncontrolled diabetes.
  • Use of continuous glucose monitoring devices is also particularly helpful for
    uncontrolled diabetes.
  • If glucocorticoids are tapered off, the diabetic treatments should also be adjusted as
    needed to ensure hypoglycemia does not occur.

2. Antipsychotics

Many drugs in this class can cause weight gain as a common side effect. As we know, obesity is a risk factor in contributing to or developing diabetes. Antipsychotics can also lead to insulin resistance. Some antipsychotics that more commonly affect glucose are Clozapine, Olanzapine, and Haloperidol. Alternatively, Ziprasidone is known to have less effects on glucose.

Tips:

  • The best approach with antipsychotics is to use ones that have less weight gain or the
    “third-generation antipsychotics” which include:
  • Abilify (Aripiprazole) – has the most coverage of FDA approved indications
  • Rexulti (Brexpiprazole)
  • Vraylar (Cariprazine)
  • Caplyta (Lumateperone)

3. Diuretics

Specifically, thiazide diuretics are a common first line therapy and adjunct in the management of high blood pressure. Some thiazide diuretics are Metolazone and Hydrochlorothiazide. Thiazide diuretics can also cause increased glucose levels in addition to affecting electrolyte levels such as potassium (hypokalemia). Studies show that hypokalemia due to thiazide diuretics can cause diabetes and reduce insulin sensitivity.

Tips:

  • Consider low dose diuretic since the side effect is dose dependent - a low dose
    thiazide may not cause hypokalemia and therefore reduce risk of diabetes.
  • Potassium levels should be monitored and manage hypokalemia with potassium
    supplements.

4. Statins

It is likely that your diabetic resident has other comorbidities such as high cholesterol which require treatment with statins. Statins are also on the list of medications that can reduce insulin secretion and sensitivity. In diabetics, statins may increase the hemoglobin A1C slightly. However, if you look at the risk vs benefit of statin therapy vs the development of diabetes, statin therapy should be initiated as the benefit to prevent cardiovascular disease and can outweigh risks with hyperglycemia.

Tips:

  • Monitoring of blood glucose and diabetic medication dose adjustments can be
    effective.
  • Atorvastatin has been linked to a greater effect on hemoglobin A1C levels.
  • Pitavastatin is associated with lower risk of new onset diabetes (but not the best data
    on cardiovascular risk reduction).
  • Pravastatin and Lovastatin are other low potency options for statins.

5. Beta Blockers

Beta blockers are commonly used for high blood pressure, coronary artery disease, and heart failure. Metoprolol and atenolol are associated with increasing hemoglobin A1C but also associated with increased risk of hypoglycemia. It is also important to keep in mind that beta blockers can mask the symptoms of hypoglycemia.

Tips:

  • Blood glucose monitoring can be beneficial especially with hypoglycemia risk.
  • Availability of Glucagon for managing hypoglycemic episode.
  • Education on managing hypoglycemia is important for diabetic patients that are
    taking Metoprolol or Atenolol.
  • Consider Carvedilol, Nebivolol, and Labetalol which show less effects on glucose.

E-Cigarette Use Among U.S. Youth Continues to Decline in 2024
August 2025

E-Cigarette Use Among U.S. Youth Continues to Decline in 2024

In 2024, the National Youth Tobacco Survey revealed a significant decrease in e-cigarette use among U.S. middle and high school students, with current use dropping from 2.13 million (7.7%) in 2023 to 1.63 million (5.9%) in 2024.

This reduction is mainly due to a decline in high school e-cigarette use, while middle school usage remained stable. The number of youth using e- cigarettes is now about one-third of the peak level in 2019. The survey also noted a decrease in the use of Elf Bar products, attributed to FDA enforcement actions. Despite these positive trends, concerns remain about any youth tobacco use, including nicotine pouches, and ongoing public health efforts are essential.

Stay Aware of Common High-Alert Medications
August 2025

Stay Aware of Common High-Alert Medications

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:

  1. Acetaminophen
  2. Chemotherapy Agents
  3. Insulin
  4. Oral Methotrexate
  5. Neuromuscular Blocking Agents
  6. Opioid Analgesics
  7. Intravenous Potassium

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.

Fall Vaccine Updates
August 2025

Fall Vaccine Updates

As we enter mid-fall and illnesses such as the influenza virus are on the rise, it is important to review the available vaccines, guidelines, and changes that have occurred. This guide will help consolidate key vaccine information into a single document for your reference and convenience as well as provide access to VIS and consent forms. Though this provides some general information, it is important to look at individualized patient needs and prescriber specific recommendations.

Flu Vaccine Recommendations

  • Everyone over the age of 6 months should receive a dose to be up to date.
  • Best time for vaccination is September/October.
  • All flu vaccines are trivalent formulation this year, inactivated, recombinant, live attenuated, along with High-Dose.
  • ACIP made a special off-label recommendation for people 18-64 with immunosuppression from organ transplant can now be given the High- Dose or adjuvanted flu vaccine which is typically indicated for ages 65+.

Flu (VIS)

Flu CPT/CVS Codes Product List

Respiratory Syncytial Virus (RSV)
Vaccine Recommendations

  • There are three currently available products.
  • This vaccine is not an annual vaccine like flu – it's a once single lifetime dose.
  • The newest vaccine Mresvia by Moderna is an mRNA vaccine, while the other two are recombinant.
  • The general recommendation is to give a single dose to all adults 60+.
  • A monoclonal antibody, Nirsevimab, is available for pediatric use for infants up to 8 months old going into their first RSV season.

RSV (VIS)

Pneumococcal Vaccine Recommendations

  • The age for routine vaccination has been lowered from 65 to 50 (PCV only).
  • Risk based recommendation still applies for individuals ages 19-49.
  • CDC approved use of the new PCV21 vaccine (Capvaxive) to be officially added to all pneumococcal recommendations.

Pneumococcal Conjugate Vaccine (VIS)
Pneumococcal Polysaccharide Vaccine (VIS)
Pneumococcal Vaccine Timing for Adults


COVID-19 Vaccine Recommendations

  • All individuals over the age of 6 months are eligible to receive a dose of the 2024-25 COVID-19 vaccine (pediatrics have more specific dosing based on prior vaccine history).
  • Adults over the age of 65, or individuals that are moderate to severely immunocompromised are now eligible to receive a 2nd dose of the 2024-25 formulation 6 months after the previous dose to be considered up to date.
  • An additional third dose can be considered based on shared clinical decision making for severely immunocompromised individuals with at least a two-month interval from last dose.
  • Reminder – moderate to severely compromised individuals dosing guidelines suggest that the initial dose series should be completed with the 2024-25 vaccine, meaning they will need the initial three-dose series and then the additional 4th dose after 6 months.
Celebrating National Safety Month
August 26, 2025

Celebrating National Safety Month

At SpecialtyRx, every month is Safety Month—but in June, we proudly join the national spotlight to raise awareness around medication safety. As a leading long-term care pharmacy, SpecialtyRx is committed to delivering safe, accurate, and clinically appropriate medications through a multifaceted approach that combines advanced technology, clinical expertise, and an unwavering focus on quality.

Here are five core ways we lead the industry in preventing medication errors:

1. Innovative Packaging that Sets the Standard

Medication safety begins with how medications are packaged. At SpecialtyRx, we utilize blister packaging (bingo cards) featuring detailed drug information and unique barcodes on every unit. Most medications are pre-packaged and pre-verified by our licensed pharmacists before they even hit the pharmacy shelves—providing an early checkpoint for identifying potential errors.

Each medication dispensed goes through a two-tier verification process:

  • A packaging scan by a pharmacy technician
  • A final barcode scan by a pharmacist to confirm it matches the prescription label

This rigorous process ensures accuracy and minimizes the risk of human error.

2. EHR Integration for Streamlined, Error-Free Orders

SpecialtyRx’s direct integration with facility Electronic Health Records (EHR) systems allows us to automatically populate prescriptions using the exact data entered at the point of care. This minimizes manual input and virtually eliminates transcription errors.

In addition, our secure EHR access means our pharmacists can log in to verify patient details, clarify questions, or confirm directions without delay—supporting faster, safer decision- making.

3. Comprehensive Clinical Oversight

Our clinical pharmacists go beyond simple order processing—they provide a thorough review of every prescription to detect potential drug-drug interactions, allergy risks, and dosing concerns.

By utilizing tools like the Specialty 365 Dashboard, our team maintains close communication with facility staff to foster a collaborative, transparent, and highly responsive care environment.

4. Industry-Leading Quality Assurance and Compliance

Safety isn't static—it evolves. Our Quality Assurance and Quality Improvement (QA/QI) teams are dedicated to tracking trends, auditing processes, and analyzing occurrences to identify potential risks before they become issues.

Led by our compliance department, this continuous feedback loop allows us to develop proactive solutions, revise protocols, and implement best practices that drive industry-wide improvements in safety.

5. Relentless Focus on Staff Training and Development

People are the heart of safety. That’s why our team is constantly learning and growing. From new hire onboarding to ongoing training and retraining, our training department works hand-in-hand with our compliance team to ensure every team member is equipped with the knowledge and skills needed to perform at the highest standard.

Weekly huddles, department meetings, and hands-on education keep our staff informed, engaged, and prepared to uphold the highest safety standards in every role.

Summer at SpecialtyRx: Prioritizing Safety, Preparedness & Continuity of Care
August 25, 2025

Summer at SpecialtyRx: Prioritizing Safety, Preparedness & Continuity of Care

As temperatures rise and weather conditions become more unpredictable, SpecialtyRx takes proactive steps to ensure the safety, efficacy, and availability of medications across all of our facilities — especially in regions where heat and extreme weather are seasonal challenges.

Our focus is clear: to preserve medication integrity and support uninterrupted patient care, regardless of the forecast.

Beating the Heat

At SpecialtyRx, we begin preparing for the summer heat well in advance. Our pharmacy and logistics teams review and reinforce best practices for cold chain management and delivery protocols to ensure the protection of temperature-sensitive medications.

Here's how we ensure medications stay within the proper range during transport:

  • Refrigerated medications are packed last, just before delivery departure.
  • Cold items, such as insulin and vaccines, are shipped with extra ice packs and placed in insulated cooler bags.
  • We use temperature-monitoring strips to track exposure during transit and ensure the integrity of our products.
  • Every delivery vehicle is equipped with a cooler and a built-in temperature gauge. Drivers are required to log temperatures throughout their routes to maintain compliance within the 36–46°F range.

Temperature fluctuations can compromise the efficacy of medications and lead to waste. That’s why we remain vigilant — because patient safety is non-negotiable.

Emergency Preparedness = Better Patient Outcomes

Summer weather can bring hurricanes, flash floods, and other natural disasters — especially in the southern regions we serve. SpecialtyRx maintains comprehensive emergency preparedness plans to ensure timely medication delivery and operational continuity in the event of any crisis.

Here’s how we stay ready:

  • Constantly monitoring forecasts and adjusting delivery schedules as needed.
  • Securing our medication supply chain and processing early refills in advance of potential disruptions.
  • Ensuring that power backup systems are fully operational so orders can continue to be filled.
  • Stocking extra ice packs, maintaining cooling systems, and using waterproof containers to protect inventory.
  • Maintaining a network of backup pharmacies near all partner facilities in case of an emergency.

Above all, we prioritize clear and proactive communication with facility teams to ensure that everyone is aligned and supported.

Tips for Facilities: Stay Ready with These Key Steps

To help our partners stay prepared, we recommend the following actions:

  • Ensure all emergency kits (antibiotics, backup boxes, IV kits, narcotic eKits) are stocked and secured.
  • Keep printed lists of all medications in eBoxes and automated dispensing systems (e.g., Cubex).
  • Maintain paper copies of patient medication profiles from your EMAR in case of power outages.
  • Request a Memo of Understanding (MOU) from SpecialtyRx, which includes a list of local backup pharmacies.
  • Place refill requests early when a weather-related evacuation or disruption is expected.
  • Keep a printed SpecialtyRx contact list, including your client service representative's name and contact information.
seminars

Continuing education with upcoming seminars