Bulletin Today
CDC releases 2024 immunization schedules for all age groups
The official 2024 immunization schedules with new vaccine recommendations for children, adolescents, and adults are now available from CDC. The updated schedules were published in late 2023.
The 2024 immunization schedules contain several changes. Notably, CDC added vaccines for meningococcal disease and mpox to the immunization schedules following recommendations from ACIP. For meningococcal disease, CDC has included information about the use of the newly licensed MenACWY-TT/MenB-FHbp (Penbraya) vaccine. They also developed a resource to assist health care providers with shared clinical decision–making recommendations for this particular vaccination. Information was added for the mpox vaccine (Jynneos) for those aged 18 years or older who are at risk.
CDC deleted the following vaccines from the 2024 schedules because they are no longer distributed or recommended: bivalent mRNA COVID-19 vaccines, 13-valent pneumococcal conjugate vaccine (PCV13), diphtheria and tetanus toxoid vaccine, and Menactra meningococcal conjugate vaccine.
The schedules summarize final recommendations by CDC. Comprehensive details will be published in CDC’s Morbidity and Mortality Report in early 2024. ■
FDA approves first OTC test for chlamydia and gonorrhea
FDA granted marketing approval to the first diagnostic test for chlamydia and gonorrhea with at-home sample collection.
Called the Simple 2 Test from LetsGetChecked, the test will be available OTC and is intended for use in individuals 18 years and older.
The Simple 2 Test is the first FDA-authorized test with at-home sample collection for any sexually transmitted disease other than HIV. The only previously cleared tests for either chlamydia or gonorrhea have required samples collected at the point of care, such as a doctor’s office.
“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in a news release. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home.”
With the new test, samples are collected at home using either vaginal swabs or urine specimens, as appropriate, and are then submitted to a designated laboratory for testing. Results are provided online, with follow up from a health care provider in cases of positive or invalid test results. ■
CDC: Vaccine exemptions for kindergartners at highest level
Parents across the country are increasingly declining to vaccinate their children as they enter school, new CDC data reveal.
While all 50 states and the District of Columbia require school-age children to be protected against measles, polio, whooping cough, and other infectious diseases, exemptions for medical reasons are permitted, with some states offering religious and philosophical exemptions as well.
Based on mandatory reporting, CDC calculated a jump in the share of kindergartners with an exemption to a new high of 3% during the 2022 to 2023 school year, from 2.6% during the previous academic year.
“It is not clear whether this reflects a true increase in opposition to vaccination, or if parents are opting for nonmedical exemptions because of barriers to vaccination or out of convenience,” the report noted.
Vaccine hesitancy and antivaccine sentiment have swelled during the pandemic, which also saw childhood vaccination rates dip for logistical reasons. Many parents have had trouble getting their child back on track in the aftermath of closed physicians’ offices, scheduling problems, and other setbacks. ■
FDA warns of potential lethal reaction to certain seizure meds
On November 28, 2023, FDA issued an alert detailing potential harms tied to the use of brand-name and generic versions of certain antiseizure medications.
According to Medscape, nearly three dozen serious cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) linked to levetiracetam have been identified around the world, including three in the United States.
Another 10 serious cases, including one domestically, have been tied to clobazam.
In response to the potential for harm, FDA said levetiracetam and clobazam labels and patient medication guides will be updated.
“Health care professionals should be aware that prompt recognition and early treatment is important for improving DRESS outcomes and decreasing mortality,” FDA noted.
Symptoms typically present early as a fever, swollen lymph nodes, and rash, but left untreated can cause damage to internal organs.
All 42 patients with known serious cases of the drug hypersensitivity reaction required hospitalization, and two—both users of levetiracetam—did not survive. ■
Pharmacists’ role in BP control saves significant U.S. health care dollars
A new economic analysis published November 3, 2023, in JAMA Network Open found that with a pharmacist-led intervention, 15 million heart attacks could be prevented for Americans as well as over a trillion dollars saved for the health care system over 30 years.
The study, led by Virginia Commonwealth University (VCU) researchers, provides data on the economics of pharmacist prescribing to improve BP control. All 50 U.S. states has given pharmacists prescriptive authority in collaboration with physicians. However, even though the United States has all the tools and resources to put pharmacist prescribing interventions in place, there is still no reimbursement for pharmacists to be paid for their clinical services.
The $1.1 trillion in health care savings over 30 years, or a cost savings of $10,162 per patient, stems from preventive measures, such as pharmacists educating patients on high BP and prescribing antihypertensive medication, as well as from helping patients better manage their BP. The ability to offer these services could mean a reduction in CV emergencies, which is crucial given the increasing mortality rates around hypertension. Over 30 years, patients could regain more than 30 million “quality-adjusted life years,” or years where their quality of life is significantly higher than it would have been if they were to have a health emergency.
Pharmacists’ services could also close gaps in poor outcomes for racial and ethnic minority groups, said Dave Dixon, PharmD, lead author of the study. Black patients aged 35 years to64 years had the highest rates of death due to hypertension of any racial or ethnic group in the United States, according to a 2020 study in the journal Hypertension. “Pharmacist-led interventions have been shown to significantly improve BP control among Black individuals and individuals of racial and ethnic minoritized groups,” wrote the JAMA Network Open study authors.
Researchers also found that if pharmacists had a larger role in prescribing medications to control BP, they could prevent more than 15 million heart attacks, nearly 8 million strokes, and more than 4 million cases each of angina and heart failure in the United States over 30 years.
“Being that hypertension affects so many Americans—we’re talking about over 100 million people in the U.S.—I think the impact is tremendous because everybody knows somebody with high blood pressure,” said Dixon in a news release. “It’s one of the leading causes of heart disease and kidney failure in the world.”
As the United States faces a shortage of primary care professionals, Dixon, who is chair of the Department of Pharmacotherapy & Outcomes Science at VCU School of Pharmacy, said pharmacists could bridge that gap.
“Pharmacists’ role as health care providers tends to be underused in the community, and this is really about how pharmacists can provide for their communities in a way that improves access to care for hypertension,” said Dixon, who also serves as an affiliate professor of internal medicine in the Division of Cardiology at the VCU School of Medicine.
According to CDC, patients visit their community pharmacist 12 times more frequently than their primary care provider. ■
Has generic imatinib reduced Medicare beneficiaries’ cost for this expensive drug?
Imatinib is one of the most effective cancer drugs available, but many patients cannot afford the steep price.
In a cross-sectional study examining whether costs have come down for Medicare beneficiaries with the introduction of generic versions of the drug starting in 2016, researchers analyzed Medicare Part D plan, contract, and formulary records for each year from 2017 to 2022.
When they looked specifically at what pharmacies paid for generic imatinib and how much health plans, PBMs, and patients paid when filling prescriptions, they found that pharmacy acquisition costs declined dramatically to $59 per fill from $8,618. Despite lower prices, Medicare beneficiaries still faced out-of-pocket costs of $80 to $400 each time they filled a prescription.
“The gap between generic imatinib point-of-sale prices and average pharmacy acquisition costs supports […] efforts to evaluate spending across PBMs, health plans, and pharmacies to avoid overpayment for medications covered under Medicare Part D,” wrote corresponding author Stacie B. Dusetzina, PhD, with Vanderbilt University School of Medicine.
The research was published in JAMA Internal Medicine on November 20, 2023. ■