2021-11-05

AILD in children: Survey on the availability of age-specific drug formulations

AUTOIMMUNE LIVER DISEASE IN CHILDREN: EUROPEAN SURVEY ON THE AVAILABILITY OF AGE-SPECIFIC PEDIATRIC DRUG FORMULATIONS

Dear Colleagues,

as you all probably now, the EU Pediatric Regulation recommends that, independently from disease epidemiology, age-appropriate drug formulations should be available for children to ensure that pediatric patients have access to treatment as well as to safe and accurate dosage of medicines (https://www.ema.europa.eu/en/human-regulatory/overview/paediatric-medicines-overview).

Despite the above-mentioned recommendation, the availability of pediatric drug formulations varies greatly across European states and is significantly inferior to that for the adult counterpart of patients.

We thus propose a short survey to investigate the availability of age-appropriate drug formulations for children with autoimmune liver disease (AILD) among members of the European Reference Network on Hepatological Diseases (ERN RARE-LIVER) and among members of the Hepatology Interest Group (HIG) of the European Society for Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN). In case of large differences across Europe and disparities in comparison to the adult population, the results of this survey could be used to ensure an equal treatment for children with AILD at a national and supranational level as well as to start a dialogue with the pharmaceutical industry.

Link to the survey: https://ec.europa.eu/eusurvey/runner/AILDchildrenmedication
We are looking forward to your response.

Best wishes,

Ruth De Bruyne (University of Ghent, Belgium)

Marianne Samyn (King’s College Hospital, UK)

Mara Cananzi (University Hospital of Padova, Italy)

Marianne Hørby Jørgensen (Copenhagen University Hospital, Denmark)