News Scan for Aug 05, 2021

News brief

Indonesian drug outlets often dispense antibiotics without prescription

A study involving simulated patients found that dispensing antibiotics without a prescription is common in Indonesian drug stores and pharmacies, despite regulations against it, researchers reported this week in BMJ Global Health.

Researchers from Indonesia, Australia, and the United Kingdom recruited and trained 21 people to visit drug outlets (community pharmacies and drugstores) in urban and rural areas of Indonesia, simulate clinical symptoms of an infection or report on another person's symptoms, and record the details of the interaction. The standardized patients (SPs) presented three clinical scenarios: a parent of a child with diarrhea, an adult with presumptive tuberculosis (TB), and an adult with an upper respiratory tract infection (URTI). The primary outcome was dispensing an antibiotic without a prescription, or without the client requesting it.

The SPs made a total of 495 visits to 166 drug outlets, and antibiotic dispensing without a prescription occurred at 69% of visits. In addition, antibiotics were frequently dispensed with few or no instructions on proper use.

Compared with drugstores, dispensing without a prescription was more likely at standalone pharmacies (odds ratio [OR], 5.9; 95% confidence interval [CI], 3.2 to 10.8) and pharmacies attached to clinics (OR, 2.2; 95% CI, 1.2 to 3.9). The odds of an SP receiving an antibiotic without a prescription were five times higher for presumptive TB (OR, 5.7; 95% CI, 3.0 to 10.8) or URTI (OR, 5.2; 95% CI, 2.7 to 9.8) than for a child with diarrhea.

Interviews with a sample of pharmacists and drug outlet staff revealed that inappropriate antibiotic dispensing was driven by strong patient demand, unqualified drug sellers dispensing medication, competition between different types of drug outlets, pressure on staff from drug outlet owners, and weak enforcement of regulations.

Under Indonesian law, licensed pharmacists can dispense antibiotics only with a prescription, and drugstores are prohibited from selling antibiotics. The study authors say stronger enforcement of those laws will not fully solve the problem.

"A multifaceted approach should be considered, taking into account the profit-maximising motives of drug outlets, the high demand for antibiotics among clients, and the push from owners to compete with other outlets, including drug stores which dispense antibiotics despite being prohibited from selling this class of medication," they wrote.
Aug 3 BMJ Glob Health study

Global flu activity in July remained low, mainly flu B

Flu activity in both hemispheres remained at interseasonal levels, with influenza B making up most of the few respiratory specimens that were positive for flu, the World Health Organization (WHO) said in its latest update, which covers the middle part of July.

Areas that reported a few detections include East and West Africa, India, Nepal, the Philippines, and Thailand.

Results from national flu labs found that 64.2% of positive samples were influenza B, and all were the Victoria lineage. Of subtyped influenza A samples, 62.2% were H3N2 and 37.8% were 2009 H1N1.

The WHO included its usual caveats that patterns should be interpreted with caution, because COVID-19 measures and surveillance could be influencing flu circulation and detection.
Aug 2 WHO global flu update

Valneva reports promising phase 3 results for chikungunya vaccine

France-based pharmaceutical company Valneva today reported promising phase 3 trial findings for its single-dose live-attenuated chikungunya vaccine. The vaccine recently received breakthrough designation status from the US Food and Drug Administration (FDA), a step designed to streamline the review process.

In a news release, the company said the vaccine, called VLA1553, prompted antibody titers in 98.5% of study participants 28 days after dosing and was well tolerated across all age-groups. The trial took place at 44 US sites and included 4,115 adults.

Safety findings were similar to results from the phase 1 trial, with about 50% reporting systemic symptoms such as headache, fatigue, and muscle ache. Most adverse events were mild or moderate and resolved within 3 days.

Juan Carlson Jaramillo, MD, the company's chief medical officer, said in the release that the company was pleased with the results. "These first-ever Phase 3 trial results for a chikungunya vaccine mean that we are a step closer to addressing this major, growing and unmet public health threat."

Valneva said it expects to report final results within 6 months.
Aug 5 Valneva press release
Jul 7 CIDRAP News scan "Valneva receives FDA breakthrough designation for chikungunya vaccine"

COVID-19 Scan for Aug 05, 2021

News brief

Heart inflammation after COVID vaccine may be more common than thought

Myocarditis and pericarditis both saw increased prevalence in COVID-19 vaccine recipients compared with a pre-vaccine period of January 2019 to January 2021, with the incidence still rare but higher than in previous studies, according to a JAMA research letter yesterday.

The researchers used electronic medical records from 40 hospitals in Washington, Oregon, Montana, and Los Angeles County to look at data from 2,000,287 people who received at least one COVID-19 vaccination from February to May 2021.

Twenty people had vaccine-related myocarditis (1.0 per 100,000 people) and 37 had pericarditis (1.8 per 100,000). No deaths occurred. Previous studies have reported a myocarditis incidence of about 0.48 per 100,000, or about half the rate in the new study, the authors say.

Overall, the average monthly number of myocarditis or myopericarditis went from 16.9 to 27.3 during the vaccination period, and pericarditis cases also increased, from 49.1 to 78.8.

Myocarditis occurred a median of 3.5 days after receiving the Moderna (11) or Pfizer/BioNTech (9) vaccine, most commonly in men (75%) and those who were younger (median age, 36). Four instances occurred after the first vaccine, and 16 occurred after the second. Two patients went on to receive the second vaccination and didn't report worsening symptoms. Although 19 were hospitalized, all were discharged after a median of 2 days. At a 23.5-day follow-up, 13 patients had no symptoms, and the remaining 7 were improving.

Fifteen people had pericarditis after the first vaccination, and 22 after the second. Again, the subgroup was predominantly men (73%), but the median age was older, at 59 years. Twelve received the Moderna vaccine and 23 the Pfizer vaccine. Median onset occurred 20 days after a vaccine dose, and while 13 were hospitalized (median stay, 1 day), none needed intensive care. Seven people received a second vaccine, but no further data were available. At 28 days' follow-up, 7 patients had no symptoms, and the remaining 23 were improving.

"This study shows a similar pattern [to previous studies], although at higher incidence, suggesting vaccine adverse event underreporting," the researchers write.
Aug 4 JAMA study

Study: Heparin not helpful for critically ill COVID-19 patients

The latest research on heparin and COVID-19 shows a mixed bag, with the blood thinner helping patients with moderate disease but failing to help patients with more severe cases, according to two studies yesterday in the New England Journal of Medicine.

The studies were based on the results of a large randomized controlled clinical trial of heparin use in 1,098 COVID-19 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). Because COVID-19 has been known to cause blood clots in patients, and hospitalized patients with COVID-19 are at a high risk for thrombosis, anticoagulants and blood thinners were hypothesized to have a therapeutic effect on patients with the novel coronavirus.

Heparin did not improve outcomes for critically ill patients, including days without organ support. Use of the drug was also associated with more major bleeding complications than usual-care prophylaxis (3.8% vs. 2.3%).

However moderately ill patients treated with therapeutic-dose heparin had a reduced need for organ support. Major bleeding was more common, however, in moderately ill patients treated with heparin (1.9% vs. 0.9%).

"These results make for a compelling example of how important it is to stratify patients with different disease severity in clinical trials. What might help one subgroup of patients might be of no benefit, or even harmful, in another," said National Heart, Lung, and Blood Institute (NHLB) Director Gary H. Gibbons, MD, in a press release.

In an editorial on the studies, Hugo ten Cate, MD, PhD, said the jury was still out on heparin treatments for COVID patients, and suggested the difference in outcomes between critically and moderately ill patients may be because in critically ill patients the "underlying thrombotic and inflammatory damage may have been too advanced to have been influenced by higher doses of heparins."
Aug 4 N Engl J Med critically ill study
Aug 4 N Engl J Med non-critically ill study
Aug 4 NHLB press release
Aug 4 N Engl J Med editorial