Developing a consensus-based competency framework for hospital pharmacists in the management of advanced therapy medicinal products (ATMPs): a modified delphi study in Macao.

backgroundAs advanced therapy medicinal products (ATMPs) increasingly enter clinical practice worldwide, many emerging markets still lack standardized pharmacy practice guidance. Macao represents one such setting where ATMP adoption is growing, yet structured competency expectations for hospital pharmacists remain limited. This study aims to develop and content-validate a competency framework (CF) for hospital pharmacists in the clinical use and management of ATMPs.

methodsA modified Delphi process incorporating the RAND/UCLA Appropriateness Method was conducted in accordance with the ACcurate COnsensus Reporting Document (ACCORD) guideline. A pharmacist expert panel (n = 15) assessed the preliminary CF through two iterative Delphi rounds using a nine-point Likert scale. Items with the disagreement index (DI) < 1 were considered appropriate for inclusion. Reliability was evaluated with Cronbach’s α and the authority coefficient (Cr).

resultsFrom the 53 potential competencies derived from a previous literature review, international guidelines, and expert opinions, all items were rated as appropriate by 15 panelists in the first Delphi round. However, revisions were proposed for 33 items based on appropriateness ratings and qualitative feedback. The revised CF was re-evaluated by 14 panelists in the second Delphi round, during which nine items were further refined to finalize the CF. Panelist feedback primarily focused on defining pharmacists’ responsibilities in ATMP management, ensuring quality assurance, clarifying procedures for preparation, dispensing, and transportation, and specifying the roles of pharmacy technicians in Macao hospitals. The finalized CF delineates pharmacists’ core competencies across six domains, covering ATMP governance and compliance, prescription evaluation, handling and storage, preparation processes, issue and transportation, administration and monitoring. Cronbach’s α indicated high internal consistency (0.975–0.979), and the average expert authority coefficients were satisfactory (0.70) in both rounds.

conclusionA consensus-based CF specific for pharmacists involved in ATMP management was developed in Macao, and its content validity was supported through a modified Delphi process. This CF provides a structured basis for strengthening pharmacists’ competencies and offers a transferable reference for policy and practice across other emerging healthcare systems.