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.

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 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.

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

Research on patient safety for off-label use of recombinant factor VIIa

2015 ◽  
Vol 72 (8) ◽  
pp. 600-602 ◽  
Author(s):  
Agnes E. Aysola ◽  
Monika M. Wahi ◽  
Russell P. McKelvey ◽  
Cynthia Russell Gerdik
Keyword(s):  
Patient Safety ◽  
Recombinant Factor Viia ◽  
Factor Viia ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

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.

scholarly journals An online survey of Australian physicians reported practice with the off-label use of nebulised frusemide

2012 ◽  
Vol 11 (1) ◽  
Author(s):  
Phillip J Newton ◽  
Patricia M Davidson ◽  
Christine Sanderson
Keyword(s):  
Online Survey ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Drug use beyond the licence in palliative care: A systematic review and narrative synthesis

2019 ◽  
Vol 33 (6) ◽  
pp. 650-662 ◽  
Author(s):  
Vera Hagemann ◽  
Claudia Bausewein ◽  
Constanze Remi
Keyword(s):  
Palliative Care ◽  
Clinical Practice ◽  
Drug Use ◽  
Meta Analysis ◽  
Management Strategies ◽  
Narrative Synthesis ◽  
Off Label Use ◽  
Off Label ◽  
Study Designs ◽  
Label Use

Background: Drug use beyond the licence (off-label use, off-label drug use) is a common practice in palliative care and respective recommendations can often be identified in the literature. It is both risky and offers opportunities at the same time and, therefore, requires special attention in clinical practice. Aim: To determine the prevalence of off-label drug use in palliative care and to identify, evaluate and critically appraise studies describing the clinical practice, healthcare professionals’ awareness, knowledge and attitudes towards off-label-use and management strategies. Design: Systematic literature review following the guidance of the Centre for Reviews and Dissemination. Data sources: Medline, Embase, Web of Science and Current Contents Connect were searched in July 2018 as well as hand searches. The reference lists of pertinent studies were screened for further relevant publications, and citation tracking was performed. Results: Eight studies met the inclusion criteria. Due to the variety in study designs and settings, no meta-analysis or meaningful statistical analysis was possible and a narrative synthesis of the data was performed. Frequency of off-label drug use ranged from 14.5% to 35%. Up to 97% of palliative care units did not have any policy or guidance on handling off-label drug use. About 20% of prescribers never obtain consent in the context of off-label use. Conclusion: Off-label use is common in palliative care with up to one-third of prescriptions affected. Challenges are often related to obtaining informed consent. Little is known about the decision-making process. More information and guidance for the prescribers are needed to enable safe handling of drugs outside their licence in palliative care.

Speech-language pathologists in paediatric palliative care: a Delphi study protocol

2018 ◽  
Vol 10 (4) ◽  
pp. e43-e43 ◽  
Author(s):  
Lillian Krikheli ◽  
Lindsay B Carey ◽  
Bernice A Mathisen ◽  
Shane Erickson ◽  
Christa L Carey-Sargeant
Keyword(s):  
Palliative Care ◽  
Clinical Practice ◽  
Delphi Study ◽  
Online Survey ◽  
Delphi Process ◽  
Scope Of Practice ◽  
Delphi Panel ◽  
Speech Language Pathologists ◽  
Paediatric Palliative Care ◽  
Palliative Care Teams

BackgroundGiven the dearth of literature and no clinical practice guidelines written for speech-language pathologists (SLPs) working in paediatric palliative care (PPC), a need has been identified to explore the scope of clinical practice and strategies used by SLPs.ObjectiveThis study aims to undertake an international investigation into the role and scope of practice of SLPs working in PPC to develop consensus-driven ‘Recommendations for Speech-Language Pathologists in Paediatric Palliative Care Teams’ (ReSP3CT).MethodsA modified Delphi process will be used to synthesise consensus-based statements from SLPs in six different countries about their role and practice working in PPC. Initially, preliminary survey data will be collected from SLPs to obtain demographic and caseload information. Respondents will then be invited to participate in an in-depth interview to explore common and unique themes that emerge from the online survey. Participants from the interview will then ‘opt-in’ to become Delphi panel members and receive questionnaires comprising statements for agreement over multiple rounds. Statements will be based on common themes that arise from the literature review, survey and interview data. The Delphi process for each statement will stop if statements achieve ≥ 70 % agreement and an IQR of ≤ 1 (maximum of five rounds).ConclusionThis is the first study to investigate the role and practice of SLPs in PPC across internationally accepted scope of practice areas. The study will use existing frameworks for statistical analysis and a mixed-methods approach to aid in the synthesis of statements/recommendations for international consensus.

scholarly journals Off-label use of dexmedetomidine in paediatric anaesthesiology: an international survey of 791 (paediatric) anaesthesiologists

2020 ◽  
Author(s):  
Camille E. van Hoorn ◽  
Robert B. Flint ◽  
Justin Skowno ◽  
Paul Davies ◽  
Thomas Engelhardt ◽  
...  
Keyword(s):  
Online Survey ◽  
International Study ◽  
Procedural Sedation ◽  
Off Label Use ◽  
Prescribing Practices ◽  
Off Label ◽  
The Usa ◽  
Paediatric Practice ◽  
Icu Sedation ◽  
Label Use

Abstract Purpose The purpose of this international study was to investigate prescribing practices of dexmedetomidine by paediatric anaesthesiologists. Methods We performed an online survey on the prescription rate of dexmedetomidine, route of administration and dosage, adverse drug reactions, education on the drug and overall experience. Members of specialist paediatric anaesthesia societies of Europe (ESPA), New Zealand and Australia (SPANZA), Great Britain and Ireland (APAGBI) and the USA (SPA) were consulted. Responses were collected in July and August 2019. Results Data from 791 responders (17% of 5171 invitees) were included in the analyses. Dexmedetomidine was prescribed by 70% of the respondents (ESPA 53%; SPANZA 69%; APAGBI 34% and SPA 96%), mostly for procedural sedation (68%), premedication (46%) and/or ICU sedation (46%). Seventy-three percent had access to local or national protocols, although lack of education was the main reason cited by 26% of the respondents not to prescribe dexmedetomidine. The main difference in dexmedetomidine use concerned the age of patients (SPA primarily < 1 year, others primarily > 1 year). The dosage varied widely ranging from 0.2–5 μg kg−1 for nasal premedication, 0.2–8 μg kg−1 for nasal procedural sedation and 0–4 μg kg−1 intravenously as adjuvant for anaesthesia. Only ESPA members (61%) had noted an adverse drug reaction, namely bradycardia. Conclusion The majority of anaesthesiologists use dexmedetomidine in paediatrics for premedication, procedural sedation, ICU sedation and anaesthesia, despite the off-label use and sparse evidence. The large intercontinental differences in prescribing dexmedetomidine call for consensus and worldwide education on the optimal use in paediatric practice.

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