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“