It’s now more important than ever that prescriptions for amoxicillin be issued only to patients who really need them, according to the French National Agency for Medicines and Health Products Safety (ANSM). The agency has notified prescribing providers that there is “significant strain” on the supply of amoxicillin in France.
The current situation results from the usual surge in seasonal infections and a faltering production line that hasn’t returned to pre-COVID levels. There have also been closures following the global drop in antibiotic use during the pandemic.
The problem, which the ANSM expects to last until March 2023, affects all pharmaceutical laboratories marketing medicinal products containing amoxicillin.
Pediatric Forms “Strained”
The ANSM has specified that the most affected pediatric forms are Clamoxyl (amoxicillin) and its generic versions (125 mg/5 mL, 250 mg/5 mL and 500 mg/5 mL doses) and Augmentin (amoxicillin/clavulanic acid) and its generic versions (100 mg/12.5 mg/mL doses).
“The disruption to the supply chain for pediatric drugs is increasingly worse and urgent in the community,” Martial Fraysse, MD, pharmacist in Fontenay-sous-Bois in the Val-de-Marne region and member of the French Pharmacy Academy, said at a joint meeting with the French Medical Academy to discuss the misuse of medicinal products. “We have already exceeded records from 2020. This issue arose for the first time before COVID and has since been aggravated by it.
“Currently, the only solution is to dispense amoxicillin 1 g as a dispersible tablet to children. This is fine for a 500-mg dose but becomes trickier when you have to divide the tablet into four for a 250-mg dose,” he added. He went on to state that “the most important thing is to not put children at risk” and that prescribers must “learn how to evaluate the parents’ capacity to fully understand that they will then have to explain how to divide the tablet to their childcare provider.”
During his talk, Fraysse listed the main pediatric medicines currently or often affected by a shortage, namely, Fluvermal syrup, Debridat oral suspension, Tiorfan (racecadotril) and Gaviscon infant.
Good Practice Guidance
The ANSM has worked with the French pediatric society’s childhood infectious diseases working group, the French association for pediatric outpatient care, and the French-language infectious diseases society to publish guidelines.
These guidelines remind prescribers that “antibiotics must not be prescribed when they are not needed (infections that are most commonly viral in nature).”
Antibiotics should also not be prescribed for the following illnesses: the common cold, laryngitis, acute otitis media, chronic otitis media, otitis for which the type is uncertain, bronchiolitis, acute bronchitis, acute tonsillitis in a child younger than age 3 years, the flu, COVID-19, asthma episode with fever, suspected pneumonia without confirmatory testing (x-ray or ultrasound, serum CRP assay), superficial skin infections (impetigo), and dermatoses with secondary impetigo or unexplained fever.
The ANSM and other medical associations advise that patients who are diagnosed with a viral infection that does not require antibiotics be given a leaflet explaining why they haven’t been prescribed antibiotics.
Adults with acute tonsillitis should take a rapid diagnostic test (RDT) for group A beta-hemolytic streptococcus to determine treatment. If the RDT can’t be carried out at the time of the appointment, prescribers are advised to write a prescription for antibiotics for conditional dispensation. “Write on the prescription, ‘If tonsillitis RDT positive, in x calendar days.’ This means that the pharmacist will not issue the antibiotic unless the RDT carried out at the doctor’s office is positive,” according to the document.
If an antibiotic must be prescribed, the ANSM stresses that recommendations for good practice that have been published by the French Health Authorities must be followed.
These adaptations, which are based on current supply chain limitations, propose shortening a course of oral antibiotics to 5 days for most common infectious diseases (eg, bacterial tonsillitis, ear infections, pneumonia).
For cases of acute otitis media in infants and children, antibiotics can be started immediately for infants younger than 6 months or for those with complicated ear infections (high fever, intense ear pain, and ear discharge), or, in children older than 6 months, if there is no improvement 36 to 48 hours after taking an antipyretic medicine.
This article was translated from the Medscape French edition.
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