Arresoedal Hospice, Frederiksvaerk, Copenhagen, Denmark
Section of Palliative Medicine, Department of Oncology, Rigshospitalet, København, Denmark.
BMJ Support Palliat Care. 2022 Dec;12(e6):e723-e729. doi: 10.1136/bmjspcare-2020-002185. Epub 2020 Sep 4.
The marketing authorisation for many injectable drugs used in palliative care does not cover the frequently preferred subcutaneous route. Consequently, subcutaneous off-label drug administration is often practised.
To assess the use, safety and tolerability of subcutaneous label and subcutaneous off-label drug administration in a Danish hospice.
Retrospective data from hospice inpatient records registered with subcutaneous drug administration. Prospective data of subcutaneous drug administration registered to hospice inpatients over a period of 2 months.
Drugs were administered subcutaneously to 90% of patients in both studied cohorts. Thirty different drugs were administered subcutaneously. Ten (33%) drugs were authorised for subcutaneous administration, 14 (47%) for intramuscular and 6 (20%) for intravenous administration only. A search in major palliative literature and scientific publications revealed that 11 of the 20 subcutaneous off-labelled drugs were administered with little to no support from these sources. In seven patients, 11 adverse drug reactions (ADRs) were registered. ADRs were all minor local reactions and led to drug discontinuation in two patients only.
Subcutaneous drug administration was frequently used in the hospice. Two-thirds of the drugs were administered subcutaneously off-label. The findings of only a few and minor ADRs indicate that the drugs identified in this study, although often subcutaneously off-label and with little support from palliative literature, were administered with acceptable safety and tolerability. Off-label treatment practised in the clinic should be identified, reported and serve as inspiration for future scientific research and incentives for extension of marketing authorisations.
许多用于姑息治疗的注射药物的营销许可并不涵盖经常首选的皮下途径。因此，皮下超说明书药物给药经常实施。
评估丹麦一家临终关怀机构中皮下标签和皮下超说明书药物给药的使用、安全性和耐受性。
回顾性数据来自姑息治疗住院患者记录中皮下药物给药的登记情况。前瞻性数据来自在 2 个月期间登记在该临终关怀机构中的皮下药物给药的住院患者。
在两个研究队列中，90%的患者都接受了皮下给药。共给予 30 种不同的药物。10 种（33%）药物被授权皮下给药，14 种（47%）药物仅被授权肌肉内给药，6 种（20%）药物仅被授权静脉内给药。在主要姑息治疗文献和科学出版物中进行检索，发现 20 种皮下超说明书药物中有 11 种给药没有得到这些来源的支持。在 7 名患者中，登记了 11 例药物不良反应（ADR）。ADR 均为轻微局部反应，仅导致 2 名患者停药。
在临终关怀机构中，皮下药物给药经常使用。三分之二的药物是皮下超说明书给药。只有少数轻微 ADR 的发现表明，本研究中确定的药物虽然经常皮下超说明书给药，且很少得到姑息治疗文献的支持，但给药具有可接受的安全性和耐受性。临床实践中的超说明书治疗应被识别、报告，并作为未来科学研究的灵感来源，以及扩大营销许可的激励措施。
