FDA leader wants pharma firms to warn of demand spikes ahead of shortages

News brief

A US Food and Drug Administration (FDA) official wants pharmaceutical companies to start reporting spikes in demand for drugs in an effort to prevent or ease shortages, Endpoints News reports.

In a webinar last week hosted by the nonprofit Alliance for a Stronger FDA, Valerie Jensen, RPh, associate director of the FDA's Drug Shortage Staff, noted increasing quality-related issues and demand for certain drugs over the past decade—but particularly amid the COVID-19 pandemic. She called on drug companies to report demand spikes, although they are currently required only to report supply disruptions.

"I think that really the key is early notification," Jensen said. "The earlier companies let us know about an issue, the earlier we can deal with it."

Drug shortages are complex and multifaceted, but one issue, she said, is that some manufacturers have had to produce COVID-19 vaccines and products in addition to or instead of their usual products. "So, the same products are being made on those lines that are making the vaccines and Covid-related products, and then that creates a competition situation, Jensen said.

The earlier companies let us know about an issue, the earlier we can deal with it.

Recent surges of respiratory illnesses such as flu and respiratory syncytial virus (RSV), together with a steady flow of COVID-19 cases, have also contributed to shortages and have complicated patient care.

Recent examples

Examples of ongoing major drug shortages are Adderall and amoxicillin. Items used to make, store, and deliver drugs (eg, glass, filters, vial-filling equipment) are also hard to source, Jensen said.

To learn whether the United States can import certain drugs from other countries, Jensen said she has stepped up coordination with international regulatory agencies. She is also working with experts to inform the public and speed the review of products that manufacturers need to increase drug supplies and with pharmacy associations and other trade groups to identify and address pharmacy-level issues.

COVID vaccine hesitancy linked to 'nocebo' side effects

News brief

Vaccine hesitancy about COVID-19 vaccines is a positive predictor of negative side effects with vaccination—an example of the "nocebo" effect—according to a study today in Scientific Reports.

Nocebo, a play on placebo, is a phenomenon in which people experience negative effects on health when they have negative views or expectations surrounding medical interventions.

The study was based on surveys of a representative sample of 756 older Israeli adults (mean age, 69 years) who were questioned following a second Pfizer vaccine dose and after their booster at least 6 months later. Older adults were selected for the study because they have the highest vaccine uptake because they are most likely to suffer complications from COVID-19 infections, the authors said.

The authors found that hesitancy about the second Pfizer dose resulted in nocebo side effects for 16% of study participants. There were sex differences seen among those who reported side effects, with women reporting increasing side effects after both the second vaccine injection and the booster dose.

Public health messaging should consider addressing the issue that side-effects comprise a nocebo component.

"Results from previous studies have indicated that side-effect severity leads to vaccine hesitancy," the study authors said. "The current results showing the opposite direction, namely that vaccination side-effects are predicted by vaccine hesitancy."

"As COVID-19 may still be a threat and vaccines are still offered, public health messaging should consider addressing the issue that side-effects comprise a nocebo component," said Yaakov Hoffman, PhD, of Bar-Ilan University and the lead study authors in a university press release.

Ohio measles outbreak sickens at least 50 kids, all unvaccinated

News brief

A measles outbreak in the Columbus, Ohio, area that began in early November with four unvaccinated sick kids with no travel history at a daycare facility has now expanded to 50 cases, according to the latest data from Columbus Public Health.

Of the 50 cases confirmed so far, 20 were hospitalized. No deaths have been reported. All 50 of the patients are unvaccinated. More than half of the patients are children between the ages of 1 and 2. The latest illness onset is Nov 30.

The US Centers for Disease Control and Prevention (CDC) recently warned about a drop in measles vaccination coverage in children, which declined during the pandemic. In a joint report, the CDC and the World Health Organization (WHO) estimate that 40 million kids missed a measles-containing vaccine in 2021, including 25 million who missed their first dose and 14.7 million who missed their second dose.

Estimate: 40 million kids missed a measles-containing vaccine in 2021.

In 2021, 22 countries experienced large outbreaks that have persisted into 2022. When combined with vaccination gaps, the outbreaks pose a threat to all world regions, the WHO and CDC said.

In the United States as of Dec 1, 76 measles cases in five jurisdictions have been reported this year. The number is up sharply from the 49 cases reported in 2021 and the 13 cases reported in 2020. However, the numbers are well below the 1,274 cases reported to the CDC in 2019.

High-path H5N1 avian flu spreads to birds in Venezuela

News brief

Venezuela reported its first detection of highly pathogenic H5N1 avian flu in wild birds, as the virus continues to expand southward in the Americas. A notification from the World Organization for Animal Health (WOAH) said the outbreak began on Nov 16 and the findings were confirmed on Nov 28.

A Venezuelan government statement translated and posted by Avian Flu Diary, an infectious disease news blog, said the outbreak occurred in pelicans in Anzoategui state on the country's north coast. Officials declared a 90-day health alert and quarantine measures for it and three other states.

In a related development, the Pan American Health Organization (PAHO) updated its recent epidemiologic alert for H5N1 avian flu, warning countries about the increase in outbreaks and urging them to strengthen animal health measures and illness monitoring in people exposed to birds. So far, H5N1 detections in wild birds and poultry have occurred in the United States, Canada, Mexico, Colombia, Ecuador, Peru, and Venezuela.

More US outbreaks

Meanwhile, the US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) reported more outbreaks in poultry flocks in five states, according to the latest updates.

In Arkansas, Nebraska, North Carolina, Missouri, and South Dakota, the virus struck backyard birds. Also, South Dakota reported another outbreak at a commercial turkey farm, this time a facility in Lake County that houses 78,000 birds.

So far, the outbreaks in US poultry, which began in February, have led to the loss of a record 52.7 million birds in 26 states.

Prescribers followed stewardship rules for scarce antibiotics 57% of the time

News brief

During shortages of five antibiotics at a Kansas City children's hospital, prescribers adhered to restriction protocols 57% of the time, according to a study published last week in the American Journal of Health-System Pharmacy.

A team led by Children's Mercy Kansas City researchers reviewed the medical records of 266 children hospitalized during shortages of five antimicrobials from 2015 to 2020 to determine adherence to restriction criteria. Shortages of the drugs, which included ampicillin/sulbactam, cefepime, meropenem, piperacillin/tazobactam, and metronidazole, were communicated to clinicians.

Among the 266 patients, antimicrobial use followed restriction criteria for 57%. The highest adherence rates were for meropenem, ampicillin/sulbactam, and piperacillin/tazobactam. Median days of therapy (DOT) were shorter in the nonadherent than in the adherent group (2 vs 4 days, respectively), and fewer average doses were given (6 vs 16, respectively).

Prescribers were most often nonadherent when using antimicrobials to rule out sepsis, prevent surgical infections, and treat urinary tract infections. The most nonadherent departments were nephrology, gastroenterology/hepatology, and critical care. The addition of the "limited availability" phrase next to a medication name in the electronic medical record (EMR) was associated with increased adherence (99% vs 94%).

DOT of all shortage antibiotics, except cefepime, fell during restriction periods, but after shortages were resolved, DOT exceeded the baseline for all antibiotics except meropenem and metronidazole, which returned to baseline. Use of one to three recommended alternative antimicrobials for each drug rose significantly during restrictions.

Factors such as patient allergies, age, and comorbid conditions further limit the selection of alternative antimicrobials.

The researchers noted that antimicrobial shortages can complicate patient care because use of nonpreferred drugs can be less effective or more toxic. "Frequently used alternative agents have a broader spectrum of activity, which can promote the development of antimicrobial resistance in the patient and community," they wrote. "Additional factors such as patient allergies, age, and comorbid conditions further limit the selection of alternative antimicrobials."

The authors said that while overall use of shortage antibiotics fell significantly during the study period, adherence to stewardship protocols was relatively low. "Overall, opportunity exists for the standardization of antimicrobial shortage management."

Shortages of drugs to treat kids' respiratory illnesses troubling doctors, parents

News brief

Recent shortages of certain drugs to treat children's respiratory illnesses are worrying both physicians and parents amid surges of respiratory syncytial virus (RSV) and the flu and continuing COVID-19 cases.

Some formulations of the prescription antibiotic amoxicillin and liquid pediatric formulations of the over-the-counter fever and pain medications acetaminophen (Children's Tylenol) and ibuprofen (Children's Advil, Children's Motrin) have been scarce in the United States, Canada, and parts of Europe. While amoxicillin isn't effective against viruses, clinicians sometimes presumptively use it for this indication, driving demand spikes that may divert it away from patients who need it for bacterial infections.

Experts worry that the lack of acetaminophen and ibuprofen to relieve symptoms could force parents to seek care for their children at urgent-care centers and emergency departments. "It's a huge problem," Kristina Powell, a Virginia pediatrician, told the Washington Post. "Parents run to Walmart or Target, the shelves are empty. … This is going to be a long fall and winter of viral infections."

Erin Fox, director of the University of Utah's Drug Information Service, which tracks medication shortages, told the Post that shortages of acetaminophen and ibuprofen were related to spikes in demand and should resolve "relatively quickly."

This is going to be a long fall and winter of viral infections.

But in Forbes, writer Joshua Cohen noted that drug shortages are a persistent problem in the United States and that there are no easy fixes. "There is no facile method to scale up production to meet periodic sharp increases in demand, like the one occurring at the moment," he said. "And there remains a limited profit motive to do so, particularly for low-cost generics."

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