ADAPTA: ADAPTED ORAL DRUG FORMULATIONS FOR PREANESTHETIC USE IN CHILDREN WITH AUTISM SPECTRUM DISORDER
European Statement
Production and Compounding
Author(s)
Carlota Mestres Gonzalvo
Juan José Lázaro Alcay
Ángela Pieras López
Marta Duero Adrados
Carlos Javier Moreno Pérez
Why was it done?
Children with ASD frequently reject standard oral medications due to sensory sensitivities, which increases distress and drives the use of invasive routes (intramuscular and/or intravenous), undermining safety, family wellbeing, and perioperative efficiency. Current forms are not adapted to ASD needs; the aim is to maximise acceptability and minimise distress through patient-friendly formulations and calming environments, ensuring equitable, high‑quality preanesthetic care.
What was done?
The project is creating and preparing to clinically evaluate novel, palatable oral formulations—such as sensory-friendly gummies—co-designed by hospital pharmacists, anaesthesiologists, and university formulation experts using advanced flavour–texture modification. In parallel, dedicated sensorial rooms with direct street-access entry, adjustable lighting and sound, and tactile comfort features are being incorporated to reduce overstimulation during preanesthetic preparation.
How was it done?
The first phase addresses obstacles such as heterogeneity in ASD sensory profiles and stringent pharmaco-technical and safety requirements. The team is overcoming these through stakeholder engagement with families, sensory mapping, iterative prototyping with in‑house stability and sensory testing, and multidisciplinary collaboration for rapid, compliant development. Hospital infrastructure supports integration, regulatory documentation, and implementation of sensorial rooms and staff training.
What has been achieved?
A multidisciplinary team has been established, equipment and consumables planned, and formulation development initiated, alongside design parameters for sensorial rooms and workflow integration. Expected outcomes include improved medication acceptance, reduced preanesthetic distress, fewer invasive interventions, greater perioperative efficiency, and higher staff confidence in ASD care, with internal dissemination and readiness for pilot evaluation.
What next?
The ADAPTA initiative is developing tailored oral drug formulations and implementing sensorial rooms to improve preanesthetic care for children with autism spectrum disorder (ASD), integrating pharmaceutical innovation with patient-centre ed strategies in a multidisciplinary hospital setting.
ADAPTA represents good practice by uniting pharmaceutical innovation with environmental and behavioural adaptations, offering a scalable, replicable model for inclusive paediatric anaesthesia. Next steps include completing prototype validation, pilot clinical and sensory acceptability studies within sensorial rooms, standardising operating procedures, and preparing for scale‑up across additional services and paediatric populations.
Clinical and economic optimisation for the management of patient at risk of respiratory syncytial virus infection
Pdf
European Statement
Clinical Pharmacy Services
Author(s)
Erica Cusumano, Giorgia Nairi, Cristina Baiamonte, Chiara Schimmenti, Lo Verso Clelia, Carolina Scaccianoce, Marcello Vitaliti, Sceila Affronti, Marco Benanti, Paolo Amari, Patrizia Marrone
Why was it done?
Until 2020, pavilizumab, refunded by National Health System for Respiratory Sincytial Virus (RSV) infection prophylaxis of paediatric patient at risk, was dispensed in 50 mg (FL 50) and/or 100 mg (FL 100) unit packs, regardless of the prescribed dose, with subsequent preparation on the ward and waste of any residual drug. Therefore, the project’s purpose, from November 2021, was to overcome the past distributive criticalities of pavilizumab.
What was done?
In our Hospital, Early Start 2.0 project (E.S-2.0) was implemented in collaboration with the neonatal intensive care unit. The E.S-2.0 purpose was to increase quality and safety of Pavilizumab galenic preparation to guarantee the patient’s health and generate an economic saving with an optimisation of hospital resources.
How was it done?
The E.S.-2.0 involved weekly drug days for the delivery to department staff of personalised galenic preparations of pavilizumab, prepared by hospital pharmacy service in a contamination-controlled environment. Through the hospital management system, prescriptions for the period November 2021 to April 2022 were extrapolated to verify the validity of the project. There were 85 patients. A palivizumab consumption database was created to evaluate the mg saved after E.S.-2.0 and the related economic savings.
What has been achieved?
Project implementation allowed us to obtain an economic saving of 9.33% related to 2339.01 mg that would have been dispensed and wasted without E.S-2.0. The results obtained considering the costs of pavilizumab (FL-50: 10.79 €/mg and FL-100: 8.96 €/mg) and our saving indicators: mg saved= mg that would have been delivered before E.S-2.0 – mg after E.S-2.0; € saved = (mg residues that would have been dispensed and wasted before E.S-2.0 from FL 100 x 8.96 €/mg) + (mg residues that would have been dispensed and wasted before E.S-2.0 from 50 x 10.79 €/mg). In addition, the personalised galenic preparations in controlled contamination pharmacy premises guaranteed a sterile pharmacological manipulation process.
What next?
E.S.-2.0 represents a cost saving policy safeguarding patient security. Practice described is worthy of implementation in hospitals not just for prophylaxis of RVS infection but also for the management of all patients undergoing treatment with therapies that can be prepared in galenical laboratory.
The European Paediatric Formulary: a reinforced approach for improved monographs
Pdf
European Statement
Production and Compounding
Author(s)
Théo Henriet, Jane Francomb, Dirk Leutner, Jörg Breitkreutz
Why was it done?
The PaedForm project was launched as a bibliographical exercise, with the aim of collecting age-appropriate formulations from existing formularies or from established sources in Europe and incorporating them into the PaedForm.
However, the data underpinning existing monographs were not as complete as expected and errors in the source data were observed. Adding an experimental verification step was therefore crucial to ensuring the reliability and the appropriate quality of the formulations described in PaedForm and demonstrating that the monographs could be used in practice.
What was done?
A decision to add an experimental verification to the elaboration process for monographs to be published in the European Paediatric Formulary (PaedForm) was recommended by the experts from the PaedF working party (PaedF WP) – assisted by the European Directorate for the Quality of Medicines & Healthcare (EDQM) – and supported by the European Committee on Pharmaceuticals and Pharmaceutical Care and the European Pharmacopoeia Commission.
This verification step involved checking the preparation against the description in the monograph and, where necessary, completing it. Samples prepared during this step were then tested to check that the quality control methods included in the monograph were suitable. The findings were used to determine whether the monograph could be completed.
Where necessary, this experimental verification would include tests such as the microbial challenge test as described in European Pharmacopoeia (Ph. Eur.) general chapter 5.1.3.
How was it done?
Experts from the PaedF WP support the need for practical verification and perform the experimental verification if needed. The EDQM supported this work by sourcing active substances and consumables and by organising analytical testing for techniques not available to the experts.
What has been achieved?
This approach enabled the enhancement of a furosemide oral formulation. The composition of this formulation as described in the source material did not meet the Ph. Eur. requirements for antimicrobial preservation, so it was changed to include a higher concentration of the preservative and comply with the Ph. Eur. requirements.
What next?
The PaedF WP will continue to expand PaedForm by elaborating new monographs covering unmet therapeutic needs. Users are invited to contribute to this process by commenting on texts published in the PaedForm Pharmeuropa public consultation platform.