Off-label drug use in home palliative care: A non-evidence-based established practice.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 225-225
Author(s):  
Laura Velutti ◽  
Carlotta Pavesi ◽  
Diego Lopane ◽  
Concetta Arcanà ◽  
Annalisa Saetta ◽  
...  
Keyword(s):  
Palliative Care ◽  
Retrospective Analysis ◽  
Evidence Based ◽  
Care Pathways ◽  
Administration Route ◽  
Off Label Use ◽  
Off Label ◽  
Treatment Interruptions ◽  
Infusion Duration ◽  
Label Use

225 Background: Advanced cancer patients (pts) often present with multiple concomitant symptoms and off-label use of drugs (indications doses formulations administration route) is a common practice. Drugs mixture (DM) solutions by continuous administration are frequently used. However, evidence-based data in this setting is scarce. Methods: We performed a retrospective analysis of 576 consecutive care pathways provided by our Home Palliative Care (HC) Service from Jul 2010 to Jun 2017. Infusions were administered subcutaneously (sc) or by a venous (iv) access, by elastomeric pumps (EP) (5 days - 2 mL/h) with drugs diluted in 0.9% NaCl with no light protection. We analyzed: treated symptoms, drugs, doses/concentrations, solution transparency, administration route, infusion duration, clinical response, adverse events (AEs), compliance/treatment acceptability, device proper functioning, and treatment interruptions. Results: We analyzed 266 pts out of 576 care pathways treated with DM infusions, M/F 143/123, median age 70 yrs (21-92); treated symptoms: pain (50%), nausea/vomiting (20%), dyspnea/agitation (20%), dysphagia/mucositis (18%); infused drugs: morphine, midazolam, dexamethasone, ranitidine, metoclopramide, scopolamine, alizapride, haloperidol, furosemide, and ketorolac. Median number of drugs in the DM was 3 (1-6). Administration route was sc in 214 pts/80%, iv in 52 pts/20%. Median infusion duration was 5 days (0-64). Symptoms control was achieved within 72 h in 69% of pts. No AEs related to the infusion devices were observed. Compliance was good in 92% of pts, poor/inadequate in 8%. 5 EP malfunctions were observed: 1 human error, 1 device obstruction due to furosemide flocculation, 3 unexplained. Also, 3 pts required sc infusion interruption due to fluid accumulation near the injection site. Conclusions: This retrospective analysis on a large number of pts shows efficacy and tolerability of DM administration by EP in the HC setting. Treatment compliance was high, no AEs were observed, EP malfunction and therapy discontinuation were rare. However, there are still many open questions about the off-label use of drugs in this setting, and prospective trials are strongly suggested.

Off-Label Use of Sunitinib in Patients with Advanced, Epithelial Thyroid Cancer: A Retrospective Analysis

2012 ◽  
Vol 6 (2) ◽  
pp. 171-176 ◽  
Author(s):  
Giuseppe Pasqualetti ◽  
Sergio Ricci ◽  
Giuseppe Boni ◽  
Sara Tognini ◽  
Antonio Polini ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Retrospective Analysis ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

scholarly journals Medicamentos passíveis de infusão por hipodermóclise

2018 ◽  
Vol 51 (1) ◽  
pp. 55-68
Author(s):  
Rita de Cássia Quaglio ◽  
Fabiana Rossi Varallo ◽  
Nereida Kilza da Costa Lima ◽  
André Felipe Junqueira ◽  
Edgar Ianhez Júnior ◽  
...  
Keyword(s):  
Palliative Care ◽  
Off Label Use ◽  
Off Label ◽  
Hospice Palliative Care ◽  
Care Nursing ◽  
Label Use

Modelo do estudo: Revisão Sistemática da Literatura e discussão com profissionais especialistas. Objetivo: Propor a lista de medicações, diluente e volume de diluição, para o uso por hipodermóclise, a pacientes acima de 18 anos Método: Com base em diretrizes Prisma, foi realizado um levantamento bibliográfico na base de dados MEDLINE através do portal Pubmed e pela biblioteca virtual SCIELO, utilizando os descritores: infusions; subcutaneous; palliative care; hospice; palliative care nursing e as palavra-chave hypodermoclysis e off-label use, seus correspondentes em português e seus cruzamentos. Os artigos encontrados foram analisados a partir do instrumento AMSTAR, seguido de discussão com profissionais de formação avançada em CP. Resultados: Dos artigos foram extraídas as seguintes variáveis: medicamentos administrados por hipodermóclise, veículo e volume de diluição, tempo de infusão, forma de administração (continua e em bolus), além de observações referentes à administração em sítio único e concentração máxima. A partir destas variáveis elaborou-se síntese em relação às medicações a serem utilizadas. Conclusões: Chegou-se a uma lista de medicações, dosagem, volume de diluição e diluente. Os resultados encontrados na literatura foram discutidos em processo dialógico e convergente, pelos profissionais de enfermagem, medicina e farmácia. Sendo assim, esta lista possui perfil replicável para outros serviços com cuidados paliativos ou que utilizam a via hipodermóclise.

scholarly journals Contrasting evidence to reimbursement reality for off-label use (OLU) of drug treatments in cancer care: rationale and design of the CEIT-OLU project

ESMO Open ◽  
2019 ◽  
Vol 4 (6) ◽  
pp. e000596
Author(s):  
Amanda Katherina Herbrand ◽  
Andreas Michael Schmitt ◽  
Matthias Briel ◽  
Stefan Diem ◽  
Hannah Ewald ◽  
...  
Keyword(s):  
Cancer Care ◽  
Clinical Evidence ◽  
Patient Characteristics ◽  
Evidence Based ◽  
Cancer Drugs ◽  
Off Label Use ◽  
Level Of Evidence ◽  
Treatment Benefit ◽  
Off Label ◽  
Label Use

BackgroundOff-label use (OLU) of a drug reflects a perceived unmet medical need, which is common in oncology. Cancer drugs are often highly expensive and their reimbursement is a challenge for many healthcare systems. OLU is frequently regulated by reimbursement restrictions. For evidence-based healthcare, treatment ought to be reimbursed if there is sufficient clinical evidence for treatment benefit independently of patient factors not related to the treatment indication. However, little is known about the reality of OLU reimbursement and its association with the underlying clinical evidence. Here, we aim to investigate the relationship of reimbursement decisions with the underlying clinical evidence.Methods/ designWe will extract patient characteristics and details on treatment and reimbursement of cancer drugs from over 3000 patients treated in three Swiss hospitals. We will systematically search for clinical trial evidence on benefits associated with OLU in the most common indications. We will describe the prevalence of OLU in Switzerland and its reimbursement in cancer care, and use multivariable logistic regression techniques to investigate the association of approval/rejection of a reimbursement requests to the evidence on treatment effects and to further factors, including type of drug, molecular predictive markers and the health insurer.DiscussionOur study will provide a systematic overview and assessment of OLU and its reimbursement reality in Switzerland. We may provide a better understanding of the access to cancer care that is regulated by health insurers and we hope to identify factors that determine the level of evidence-based cancer care in a highly diverse western healthcare system.

DI-028 Off-label use: a descriptive retrospective analysis

2015 ◽  
Vol 22 (Suppl 1) ◽  
pp. A86.1-A86
Author(s):  
S Buendía-Bravo ◽  
A Giménez Manzorro ◽  
B Monje García ◽  
M Sanjurjo Sáez
Keyword(s):  
Retrospective Analysis ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Off-Label Use of Drugs in Pain Medicine and Palliative Care: An Algorithm for the Assessment of its Safe and Legal Prescription

Pain Practice ◽  
2008 ◽  
Vol 8 (3) ◽  
pp. 157-163 ◽  
Author(s):  
Constans C. A. H. H. V. M. Verhagen ◽  
Anne G. H. Niezink ◽  
Yvonne Y Engels ◽  
Yechiel Y. A. Hekster ◽  
Joan J. Doornebal ◽  
...  
Keyword(s):  
Palliative Care ◽  
Pain Medicine ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Off-label drugs in palliative care: a Group Delphi treatment recommendation process

2020 ◽  
pp. bmjspcare-2019-002165
Author(s):  
Constanze Remi ◽  
Kathrin Weingärtner ◽  
Vera Hagemann ◽  
Claudia Bausewein ◽  
Farina Hodiamont
Keyword(s):  
Palliative Care ◽  
Patient Safety ◽  
Online Survey ◽  
Delphi Process ◽  
Treatment Quality ◽  
Direct Patient Care ◽  
Treatment Recommendation ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

ObjectivesThe use of drugs beyond their marketing authorisation, that is, off-label use, is common practice in palliative care with over 70% of off-label use having little or no scientific support. The lack of evidence makes recommendations for off-label use essential, in order to increase the safety of drug therapy and thus patient safety. The aim of this study was to develop a guide for preparing and consenting drug-specific recommendations for off-label use in palliative care.MethodsGroup Delphi Study with three rounds and a prior online survey to identify topics of dissent. Participants represented professional groups working in palliative care involved in direct patient care and/or drug management and various care settings. Furthermore, representatives of relevant professional associations, experts with academic, non-clinical background and experts with international expertise were invited.Results18/20 invited professionals participated in the prior online-survey. 15 experts participated in the Group Delphi process. Six domains, including identification of drugs, drug uses, assessment of evidence, formulation, consensus and updating of recommendations were generated and respective statements were included in the Group Delphi process. The consensus process resulted in 28 statements forming the guide for recommendations.ConclusionsThe resultant systematic approach for preparing and consenting drug-specific recommendations for off-label use will allow the development of recommendations with transparent and reproducible monographs. This will help to increase treatment quality and patient safety as well as security of decision-making in palliative care. The developed guide is part of a larger project aiming to provide therapy recommendations for areas that have little or no scientific evidence.

scholarly journals Guide for recommendations on specific drug-related off-label treatment in palliative care: A Group Delphi process

2019 ◽  
Author(s):  
Constanze Remi ◽  
Kathrin Weingärtner ◽  
Vera Hagemann ◽  
Claudia Bausewein ◽  
Farina Hodiamont
Keyword(s):  
Palliative Care ◽  
Patient Safety ◽  
Delphi Study ◽  
Online Survey ◽  
Delphi Process ◽  
Treatment Quality ◽  
Direct Patient Care ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Abstract Background The use of drugs beyond their authorisation label, i.e. off-label-use, is common practice in palliative care with over 70% of off-label-use having little or no scientific support. Recommendations for off-label-use are essential to increase the safety of drug therapy and thus patient safety. The aim was to develop a guide for preparing and consenting drug-specific recommendations for off-label-use in palliative medicine.Methods Group Delphi Study with three rounds and a prior online survey. Participants represented professional groups working in palliative care involved in direct patient care and/or drug management (doctors, pharmacists, nurses) and various care settings (inpatient/community, university/non-university). Furthermore, representatives of relevant professional associations, experts with academic, non-clinical background and experts with international expertise were invited.Results For the preliminary online-survey 18/20 invited participants returned 18 questionnaires. Six domains, including identification of drugs, drug uses, assessment of evidence, formulation, consensus and updating of recommendations were generated and eventually 22 statements were included in the Group Delphi process. 15 experts participated in this consensus process. In combination with the survey results, consensus was achieved over a 28 statements after 3 Delphi rounds.Conclusions The resulted systematic approach for preparing and consenting drug-specific recommendations for off-label-use will allow to develop such recommendations with transparent and reproducible monographs. This will help to increase treatment quality and patient safety as well as security of decision-making in palliative care. The developed guide is part of a larger project aiming to provide therapy recommendations for areas that have little or no scientific evidence to date.

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