Bulletin Today
APhA Staff
A new study suggests that COVID-19 vaccination hesitancy has spilled over into influenza vaccination hesitancy. Researchers from UCLA found that adult flu vaccination rates declined in states with low rates of COVID-19 vaccination, which the authors say may be an indication of declining trust in public health.
“It is alarming that controversy surrounding COVID-19 vaccination may be undermining separate public health efforts that save thousands of lives each year,” said the study’s lead author, Richard Leuchter, MD, a resident physician at UCLA Health and the David Geffen School of Medicine, in a news release. “Many Americans who never before declined a routine, potentially lifesaving vaccine have started to do so. This supports what I have seen in my clinical practice and suggests that information and policies specific to COVID-19 vaccines may be eroding more general faith in medicine and our government’s role in public health.”
The findings were published in The New England Journal of Medicine as a letter to the editor on June 15, 2022.
The study authors used publicly available data from CDC to evaluate how flu vaccination rates changed during the pandemic based on statewide rates of COVID-19 vaccination. They found that flu vaccination rates for the first flu season of the pandemic (2020–2021), which predated the widespread availability of COVID-19 vaccines, remained relatively stable across all states.
However, in the second flu season of the pandemic (2021–2022), which was after widespread promotion of COVID-19 vaccines, flu vaccination rates dropped 4.5 percentage points (from 43.7% to 39.2%) in states with below-average rates of COVID-19 vaccination. Conversely, states with the highest uptake of COVID-19 vaccines saw increases in average flu vaccination rates of 3.8 percentage points (from 49.0% to 52.8%).
The study, however, did not directly measure individuals’ beliefs or reasons for forgoing vaccination. As an observational study, it did not prove that lack of trust of the vaccines or government caused the new decline in flu vaccination rates.
Despite these limitations, the researchers state that these findings should raise alarm and prompt rigorous study of the causes of decreases in non-COVID-19 vaccination rates. ■
FDA: Pharmacists can prescribe Paxlovid to treat COVID-19
Pharmacists across the country can now order and prescribe nirmatrelvir/ritonavir (Paxlovid—Pfizer), an option they were not granted under the original EUA for COVID-19 treatment authorities.
FDA made the change after a CDC analysis upheld APhA’s findings of inequitable dispensing of COVID-19 oral antiviral medications.
Now, state-licensed pharmacists may prescribe Paxlovid to individual patients as long as they have adequate medical documentation to evaluate the patient’s renal and hepatic function and to gauge the risk for potential drug interactions.
Ilisa BG Bernstein, PharmD, JD, FAPhA, interim executive vice president and CEO of APhA, thanked FDA for recognizing pharmacists as educated and trained professionals with much to contribute in terms of delivery of COVID-19 treatments.
“Removing barriers to pharmacist prescribing of oral antivirals has the potential to be a game-changer for addressing health equity and providing timely access to these life-saving treatments in pockets of the country where pharmacists may be the only health care provider for miles—just as it has been for the administration of COVID-19 vaccines,” Bernstein said. She added that it is critical for CMS and other payers to adequately reimburse pharmacists for consultations and services. ■
FDA introduces proposal to advance consumer access to nonprescription drugs
FDA issued a proposed rule aimed at expanding the range of marketed nonprescription drugs available to consumers. The Nonprescription Drug Product with an Additional Condition for Nonprescription Use rule seeks to empower consumers to self-treat certain common conditions and improve public health.
“Nonprescription drug products play a vital role in America’s health care system, as millions of people use them to self-manage conditions every day,” said FDA Commissioner Robert M. Califf, MD. “As part of the FDA’s ongoing efforts to improve public health, this proposal can broaden the types of drugs that can be approved as nonprescription—increasing availability of drugs that would otherwise only be available by prescription.”
If finalized, the proposed rule would establish the requirements for a drug company that submits a new application to bring a nonprescription drug product to market with an additional condition for nonprescription use. Under the proposal, when FDA determines that labeling alone is not enough to ensure the consumer can appropriately self-select and use a drug in a nonprescription setting, an applicant may submit an application proposing an additional condition for nonprescription use that a consumer must successfully fulfill in order to obtain the nonprescription drug.
FDA is encouraging public comment on the proposed rule. ■
CDC director adopts preference for specific influenza vaccines for older adults
CDC Director Rochelle P. Walensky, MD, MPH, adopted the Advisory Committee on Immunization Practices (ACIP) recommendation to preferentially recommend the use of specific influenza vaccines for adults aged 65 years and older, including higher-dose and adjuvanted flu vaccines.
The preference applies to the Fluzone High-Dose Quadrivalent (Sanofi Pasteur), Flublok Quadrivalent (Sanofi), and Fluad Quadrivalent (Seqirus) flu vaccines.
ACIP recently voted to preferentially recommend the use of higher-dose or adjuvanted flu vaccines over standard-dose unadjuvanted flu vaccines for older adults after a review of available studies indicated that, for this age group, these vaccines are potentially more effective than standard-dose unadjuvanted flu vaccines.
Walensky’s adoption of the ACIP recommendation makes it official CDC policy, and it will be further detailed in an upcoming Morbidity and Mortality Weekly Report. ■
CDC finds antiviral drugs for COVID-19 are inequitably prescribed
A new CDC study found that in recent months, consumers living in the most economically and socially disadvantaged communities were only one-half as likely as those in affluent areas to receive a prescription for oral antiviral medications against COVID-19.
The study, published June 21, 2022 in CDC’s Morbidity and Mortality Weekly Report, analyzed more than 1 million prescriptions dispensed for nirmatrelvir/ritonavir (Paxlovid—Pfizer) and molnupiravir (Lagevrio—Merck and Ridgeback Biotherapeutics) between December 23, 2021, and May 21, 2022.
Researchers used ZIP codes to classify geographic areas as having low, medium, or high social vulnerability. They found that in areas of high social vulnerability, prescriptions were written at one-half the rate as in ZIP codes classified as medium or low-social vulnerability.
The differences emerged even though roughly one-half of the sites capable of dispensing the drugs were located in the disadvantaged areas. The researchers noted that patients who sought to obtain the antivirals first needed to test positive for SARS-CoV-2 followed by a visit to a health care provider. Thus, they suggested that a clinical assessment and medication be made available during a single visit.
Cost also may be a hurdle because of the March 22, 2022, termination of a federal program that reimbursed uninsured individuals for the costs of testing, seeing a health care provider, and obtaining medication. ■
Unexplained hepatitis in children happened before pandemic, CDC study suggests
CDC investigators probing a rash of mysterious hepatitis illnesses in children across the country have one reassuring finding to report so far: cases are not occurring with any greater frequency now than before the COVID-19 pandemic.
The team of researchers began exploring a potential tie-in to COVID-19 and/or adenovirus after ruling out many of the usual culprits behind hepatitis. They reviewed 3 large medical databases and found that the number of weekly emergency department visits, monthly hospital admissions, and monthly liver transplants linked to unexplained and severe hepatitis were not significantly higher in late 2021 and early 2022 than during prepandemic years going back to 2017. They published their findings in the June 17, 2022, issue of CDC’s Morbidity and Mortality Weekly Report.
Another finding showed that, based on routine screening of pediatric stool samples, positive results for adenovirus types 40 and 41 also were not significantly greater in recent months. The study is far from definitive and more work is needed, said the researchers, noting that a slight upward trend in cases could go easily undetected since the diagnosis is so uncommon. It also is possible that clusters of cases both domestic and overseas simply reflect greater awareness of a problem that has existed all along.
“Ongoing assessment of trends, in addition to enhanced epidemiologic investigations, will help contextualize reported cases of acute hepatitis of unknown etiology in U.S. children,” the study authors wrote. ■
House passes mental health and SUD package with pharmacists’ input
In June 2022, the U.S. House of Representative passed a broad bipartisan mental health and substance use disorder (SUD) package known as the Restoring Hope for Mental Health and Well-Being Act of 2022 (H.R. 7666).
Included in this bill was language, long supported by APhA, that was originally found in the Mainstreaming Addiction Treatment Act (H.R. 1384). The legislation removes the requirement for certain health professionals to apply for and receive an X-waiver from DEA to prescribe buprenorphine. Because pharmacists are not eligible to apply for this waiver, this requirement prevented them from providing lifesaving treatment to patients across the country.
APhA, along with over 100 other organizations, signed onto a support letter to help get this measure passed. This is a huge win for pharmacists and the patients they serve. ■