Presentation (CTI)

OBJECTIVES: The Health Service Executive Primary Care Reimbursement Service (HSE-PCRS) first introduced the High Tech Ordering and Management System (the High Tech Hub [HTH]) in Ireland, in March 2018 as an electronic stock management facility for medicines reimbursed under the High Tech Arrangement in the primary care setting. It was recognised as part of the national electronic prescription transfer system in August 2020. Off-label use of a medicinal product refers to the use of an authorised medicinal product outside the terms of its marketing authorisation or product registration. The aim of this study was to analyse prescription data from the HTH to identify off-label use of the biological medicine ustekinumab, reimbursed under the High Tech Arrangement.
METHODS: Anonymised prescription data from the HTH relating to ustekinumab (ATC code L04AC05) for the six month time period between January and June 2023 were extracted and analysed using Microsoft Excel™. Off-label use was identified through prescribing of ustekinumab at a dosage greater than the maximum licensed maintenance dosage (90mg every eight weeks).
RESULTS: The analyses highlighted high levels of off-label prescribing of ustekinumab under the High Tech Arrangement. Of the 4,085 prescriptions generated within the time period, 576 (14.1%) were for an off-label maintenance dosage of ustekinumab. When analysing by clinical speciality of the prescriber, the majority of these prescriptions were generated by gastroenterologists. Of 1,366 prescriptions generated by gastroenterologists, 548 (40.1%) were for an off-label dosage of ustekinumab.
CONCLUSIONS: The implementation of electronic prescribing initiatives such as the HTH enables better visibility and interrogation of prescribing practices. This in turn allows the identification of prescribing and utilisation of medicines outside of their formal reimbursement approval, and the introduction of health technology management measures to control same.