EU to propose changing laws to address growing drug shortages

News brief

In March, the European Union (EU) will propose amending laws governing pharmaceuticals to require increasing stocks of essential medicines and offering more timely notifications of shortages, Reuters reports.

Yesterday, Stella Kyriakides, European commissioner for health and food safety, told the European Parliament that the proposal was spurred by growing antibiotic shortages. Twenty-six of the 27 EU countries have reported shortages to the European Medicines Agency amid an early surge of respiratory infections this fall.

"Our objective is and remains to secure access to medicines for all patients in need and to avoid any market disruption of medicines in the EU," Kyriakides said.

Exercising all options

EU legislators told the European Parliament that the shortages were urgent, but some experts told Reuters that shortfalls of essential generic drugs such as antibiotics were unlikely to be resolved because of the outsourcing of generic manufacturing to Asia.

Kyriakides said the EU is using all available regulatory options and is asking drug companies to boost production. She also said that the Health Emergency and Preparedness and Response Authority, the EU's health crisis group established in response to COVID-19, could help source drugs and medical supplies on behalf of member states.

Our objective is and remains to secure access to medicines for all patients in need and to avoid any market disruption.

Also yesterday, Supply Management reported that European countries have started stockpiling essential medicines and taking other mitigation measures.

Earlier this month, Greece banned the export of drugs after it found that pharmaceutical firms were importing drugs into the country at low prices before marking them up and exporting them again, leading to internal shortages. France also outlawed the online sale of the over-the-counter painkiller paracetamol (acetaminophen) to ensure availability of the drug in retail stores.

More than 65 million people around the world may have long COVID

News brief

Worldwide, at least 65 million people have long COVID, and that is likely an underestimate, finds a review article published late last week in Nature Reviews Microbiology.

Investigators from the Patient-Led Research Collaborative and Scripps Research Translational Institute reviewed the current literature on long-COVID in nonhospitalized adults.

Misinformation, underrecognition

The researchers said that the number of affected COVID-19 survivors was based on the estimated global rate of 10% of infected people and the more than 651 million documented cases. They cited the lack of polymerase chain reaction (PCR) test availability at the beginning of the pandemic and the high false-negative rate of rapid antigen tests as reasons for suspecting an undercount.

"Similarly, there is a broad misconception that everyone makes and retains SARS-CoV-2 antibodies, and many clinicians and researchers are unaware of the limited utility of antibody tests to determine prior infection," they wrote. "Between 22% and 36% of people infected with SARS-CoV-2 do not seroconvert, and many others lose their antibodies over the first few months."

There is a broad misconception that everyone makes and retains SARS-CoV-2 antibodies.

This misinformation, as well as the underrecognition of the nonrespiratory manifestations of long COVID, have skewed both the electronic health record (EHR) data and the research output, the authors said.

EHR data, they continued, are also more comprehensive for hospitalized patients, "leading to a bias toward the more traditional severe respiratory presentation and less focus on non-hospitalized patients," who tend to have neurologic or immune-related presentations.

The researchers said that current diagnostic and treatment options for long COVID are lacking and that clinical trials are needed to pinpoint the condition's mechanisms. "Additionally, to strengthen long COVID research, future studies must account for biases and SARS-CoV-2 testing issues, build on viral-onset research, be inclusive of marginalized populations and meaningfully engage patients throughout the research process," they wrote.

The team also called for training of the healthcare and research workforce on long COVID, a public education campaign, and policies and funding to support research and patient care.

Trial supports shorter postoperative antibiotics for complex appendicitis

News brief

A randomized clinical trial conducted in the Netherlands shows that 2 days of postoperative intravenous (IV) antibiotics for complex appendicitis is non-inferior to 5 days, Dutch researchers reported yesterday in The Lancet.

In the open-label non-inferiority trial, patients with complex appendicitis at 15 Dutch hospitals were randomly assigned to receive 2 days or 5 days of IV antibiotics after appendectomy. The primary end point, based on electronic patient records and a telephone consultation 90 days after appendectomy, was a composite of infectious complications and mortality within 90 days. The non-inferiority margin for the absolute risk difference, adjusted for age and severity of appendicitis, was 7.5%.

A total of 1,066 patients were randomly assigned to the two treatment arms from Apr 12, 2017, to Jun 3, 2021, with 533 in each group. Appendectomy was done laparoscopically in 955 (95%) of 1,005 patients. The primary end point occurred in 51 (10%) of 502 patients in the 2-day group and 41 (8%) of 503 patients in the 5-day group, for an adjusted absolute risk difference of 2.0% (95% confidence interval [CI], -1.6% to 5.6%) in favor of the 5-day group. Fewer patients in the 2-day group had adverse effects from antibiotics than in the 5-day group (9% vs 22%; odds ratio [OR], 0.34; 95% CI, 0.24 to 0.50), while hospital re-admission was more frequent in the 2-day group than in the 5-day group (12% vs 6%; OR, 2.14; 95% CI, 1.43 to 3.37).

"This study supports the idea that extended antibiotic prophylaxis for intra-abdominal infections is not indicated after adequate source control," the investigators wrote.

In an accompanying commentary, researchers from the United Kingdom, Sweden, and Rwanda note that a shorter postoperative antibiotic course should be used cautiously in low- and middle income settings, where presentation to surgeons takes longer and laparoscopic surgery is less commonly available.

"A whole body of research is necessary for health systems in low-income and middle-income countries, including to understand challenges around access and diagnosis, implementing sustainable laparoscopic capacity, and identifying the optimum context-specific antibiotic strategies," they wrote.

A whole body of research is necessary for health systems in low-income and middle-income countries.

Researchers identify Candida auris in Nevada wastewater

News brief

A team of researchers from Nevada and Utah this week reported the detection of Candida auris in samples from a wastewater treatment plant.

In a dispatch published in Emerging Infectious Diseases, a team led by scientists with the Utah Department of Health and Human Services and the Nevada Department of Health and Human Services described the culture-based recovery of C auris colonies in one of eight samples collected at a wastewater treatment plant in southern Nevada from May 23 to Jun 13, 2022, during an intense outbreak of the multidrug-resistant yeast. Genomic analysis of two separate wastewater-derived C auris isolates revealed phylogenetic relatedness to isolates from three acute-care hospitals in the same watershed.

It remains to be determined whether C. auris could be detected in geographic areas by wastewater surveillance before being recognized in clinical settings.

The first clinical case of C auris in Nevada was identified in June 2021. As of June 2022, a total of 300 C auris cases had been reported in 22 healthcare facilities in Nevada. According to Centers for Disease Control and Prevention tracking data, there were 1,994 clinical cases reported in 28 states from October 2021 to September 2022.

The authors say the findings highlight the potential utility of community-level wastewater surveillance for C auris, which spreads easily in healthcare settings and can cause severe and deadly infections in patients who have compromised immune systems. But they note there are limitations to their methods, which involved growing the culture in the presence of the antifungal fluconazole, which prevented other Candida species from growing. C auris is frequently resistant to fluconazole.

"It remains to be determined whether C. auris could be detected in geographic areas by wastewater surveillance before being recognized in clinical settings," they wrote. "Regardless, wastewater surveillance of pooled samples at the community level might effectively complement clinical surveillance of individual patients for detecting and characterizing C. auris outbreaks."

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