R05 - Off-label drugs use in home care: a non evidence-based established practice

Abstract

Background: Advanced cancer patients (pts) experience many different symptoms and the use of drugs in off-label indications, doses, formulations and administration route is a common practice in this setting. Drugs mixture (DM) solutions by continuous administration are frequently utilized. However, evidence-based data on the use of off-label drugs in this patients subset is scarce. Patients and methods: A retrospecitive analysis of 484 consecutive assistential pathways provided by our Home Care Service from July 2010 to April 2016 was performed. Elastomeric pumps (5 days - 2 ml/h) with drugs diluited in 0.9% NaCl without protection from light were used. Infusions were administreted subcutaneously (sc) or by a central venous (iv) access. Analysis was performed on: treated symptoms, drugs, doses and concentrations, solution transparency, adminitration route, infusion duration, clinical response, adverse events (AEs), compliance and treatment acceptability, device proper functioning and treatment interruptions. Results: 226 pts/484 pathways (47%) treated with DM infusions were identified, M/F 121/105, median age 70 yrs (range 21-92), treated symptoms were pain (50%), nausea/vomiting (20%), dyspnea/agitation (20%), dysphagia/mucositis (18%). Most of pts had >1 symptom. Infused drugs included morphine, midazolam, dexamethasone, ranitidine, metoclopramide, scopolamine, alizapride, haloperidol, furosemide and ketorolac. The median number of drugs in the DM was 3 (range 1-6). The administration route was sc in 174 pts (77%), iv in 52 pts (23%). Median/mean infusion duration was 5/9.6 days (range 0-64). Symptom control was archieved within 72 hours in 69% of pts. No AEs related to the infusion devices were observed. Compliance was good in 92% of pts, poor/inadequate in 8%. 4 elastomeric pumps malfunctions were observed: 1 human error, 1 device obstruction due to furosemide flocculation, 2 unexplained. Also, 2 pts required sc infusion interruption due to fluid accumulation near the injection site. Conclusions: This retroscpective analysis showed efficacy and tolerability of DM administration by elastomeric pumps in the home care setting. Treatment compliance were high. No AEs were observed, pump malfuncion and therapy discontinuation were rare. However, there are still many open questions about the off-label use of drugs in this setting. Prospective trials are strongly suggested.