The Contribution to the Assignment of Defined Daily Dose ( <scp>DDD</scp> ) to Antineoplastic Drugs of the Italian Working Group on <scp>DDD</scp>
PURPOSE: To report the experience of the Italian Working Group on DDD (Ita-DDD-wg) in assigning DDDs to a list of antineoplastic agents. METHODS: Active substances from the ATC L01 group with no assigned DDD and reimbursed at least once during 2021 by the Italian Healthcare Service were identified. A DDD-assignment reporting template was developed, including the following fields: ATC fifth-level code, active substance, route of administration, reference indication of use, reference posology, assignment criteria, DDD calculation formula, DDD value, and DDD unit of measure. Information from national and international Summaries of Product Characteristics of medicines containing the active substance of interest, along with evidence from literature and input from Ita-DDD-wg experts, were considered. DDD assignment criteria were based on ATC/DDD guidelines and, whenever necessary, complemented by ad hoc criteria. RESULTS: ), treatment cycle duration, and average daily amounts of topical product. CONCLUSION: This work demonstrated that assigning DDDs to antineoplastic agents is feasible based on few additional assumptions and criteria with respect to those from ATC/DDD guidelines. In fact, based on this work, WHO decided to establish an ad hoc working group for evaluation and assignment of DDDs to antineoplastic agents.
Authors
- Martina Zanforlini
- Michele Ercolanoni (ORCID: https://orcid.org/0000-0002-1484-9086)
- Marco Finocchietti (ORCID: https://orcid.org/0009-0008-4265-448X)
- Ursula Kirchmayer (ORCID: https://orcid.org/0000-0001-7732-0166)
- F Barone-Adesi
- Giampiero Mazzaglia (ORCID: https://orcid.org/0000-0003-4933-2148)
- Anna Girardi
- Elena Tragni (ORCID: https://orcid.org/0000-0001-9932-415X)
- Gianluca Trifirò (ORCID: https://orcid.org/0000-0003-1147-7296)
- Elisabetta Poluzzi (ORCID: https://orcid.org/0000-0002-7209-0426)
- Giuseppe Roberto (ORCID: https://orcid.org/0000-0001-6478-6442)
- Arianna Mazzone
- Giulia Hyeraci (ORCID: https://orcid.org/0000-0002-6536-2083)
- Olivia Leoni (ORCID: https://orcid.org/0000-0002-6906-2424)
- Ippazio Cosimo Antonazzo (ORCID: https://orcid.org/0000-0001-8046-4574)
- Rosa Gini (ORCID: https://orcid.org/0000-0002-6250-877X)
- Valentina Ientile
- Andrea Spini (ORCID: https://orcid.org/0000-0001-7496-5575)
- Casula Manuela
- Angela Boccia
- Belleudi Valeria (ORCID: https://orcid.org/0000-0002-8286-443X)
- Ylenia Ingrasciotta
Institutions
- Agenzia Regionale per la Protezione Ambientale del Piemonte (IT)
- University of Verona (IT)
- Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT)
- University of Milan (IT)
- University of Ferrara (IT)
- ASL Roma (IT)
- Agenzia Regionale di Sanità della Toscana (IT)
- Lombardia Informatica (Italy) (IT)
- University of Milano-Bicocca (IT)
- University of Bologna (IT)
Publication Details
- Journal
- Pharmacoepidemiology and Drug Safety
- Published
- 2026-05-01
- DOI
- https://doi.org/10.1002/pds.70379
- Primary Topic
- Safe Handling of Antineoplastic Drugs
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Eli Lilly and Company
- Pfizer
- Sanofi
- Biogen
- Novo Nordisk
- Shionogi
- Università degli Studi di Verona
- Daiichi Sankyo Europe