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

Hagemann, Vera; Bausewein, Claudia; Rémi, Constanze

doi:10.1177/0269216319840602

Cited by 27 publications

(24 citation statements)

References 22 publications

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“…17 Conversely, this approach to symptoms, commonly used in the hospice population, may not always be appropriate for older residents in the aged care setting. Off-label prescribing, a common practice in palliative care, 74 may be particularly risky for the residential aged care population.…”

Section: Discussionmentioning

confidence: 99%

Medication use in aged care residents in the last year of life: A scoping review

et al. 2020

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Background: A substantial number of older adults die in residential aged care facilities, yet little is known about the characteristics of and how best to optimise medication use in the last year of life. Aim: The aim of this review was to map characteristics of medication use in aged care residents during the last year of life in order to examine key concepts related to medication safety and draw implications for further research and service provision. Design: A scoping review following Arskey and O’Malley’s framework was conducted using a targeted keyword search, followed by assessments of eligibility based on title and content of abstracts and full papers. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, the scoping review protocol was prospectively registered to the Open Science Framework on 27 November 2018. Data Sources: We searched MEDLINE, EMBASE, AMED, CINAHL and Cochrane databases to identify peer-reviewed studies published between 1937 and 2018, written in English and looking at medication use in individuals living in aged care facilities within their last year of life. Results: A total of 30 papers were reviewed. Five key overarching themes were derived from the analysis process: (1) access to medicines at the end of life, (2) categorisation and classes: medicines and populations, (3) polypharmacy and total medication numbers, (4) use of symptomatic versus preventive medications and (5) ‘inappropriate’ medications. Conclusion: Number of prescriptions or blunt categorisations of medications to assess their appropriateness are unlikely to be sufficient to promote well-being and medication safety for older people in residential aged care in the final stages of life.

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Section: Discussionmentioning

confidence: 99%

Medication use in aged care residents in the last year of life: A scoping review

et al. 2020

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“…W Wielkiej Brytanii zgodę na wykorzystanie leków poza wskazaniami uzyskiwało mniej niż 5% konsultantów medycyny paliatywnej [20]. Do wyjątków jednak należą ośrodki opieki paliatywnej, w których istnieją opracowane wewnętrzne zalecenia dotyczą-ce stosowania leków poza wskazaniami [21]. W niniejszym badaniu spośród procedur pozarejestracyjnych blisko 40% jest stosowanych często i bardzo często przez oceniających ekspertów.…”

Section: Dyskusjaunclassified

Off-label drug use in palliative care in Poland

Dzierżanowski¹,

Grądalski²,

Graczyk³

et al. 2020

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Wstęp: Pozarejestracyjne zastosowanie leku ma miejsce wówczas, gdy podawany jest on we wskazaniach, dawkach, formach, drogami podania oraz w grupach pacjentów niewymienionych w charakterystyce produktu leczniczego lub pomimo przeciwwskazań. Cel pracy: Prowadzenie badań klinicznych w populacji pacjentów objętych opieką paliatywną z przyczyn etycznych jest znacznie ograniczone, a wręcz niemożliwe, wobec czego dość często wprowadza się leki, opierając się na doświadczeniu klinicysty, powszechnej praktyce lub utartej opinii. Pozarejestracyjne zastosowanie leku może nie przynosić pożądanych efektów, a nawet szkodzić. Materiał i metody: W badaniu zebrano 304 doniesienia o możliwym pozarejestracyjnym zastosowaniu leków w Polsce. Po odrzuceniu doniesień błędnych, powtarzających się lub nieuzasadnionych ostatecznie zostało 86 procedur poza wskazaniami u dorosłych w opiece paliatywnej, dla których dokonano przeglądu piśmiennictwa oraz które poddano ocenie przez zespół ekspertów. Wyniki: Eksperci potwierdzili stosowanie w swojej praktyce w dwóch trzecich przypadków tych procedur, a w 37,1%-często lub bardzo często. Dziewięć spośród nich specjaliści ocenili jako procedury niezbędne, niemające alternatywy. W ten sposób powstała lista zastosowań pozarejestracyjnych ze sformułowanym zaleceniem, kategorią niezbędności, jakością dowodów oraz stopniem rekomendacji. Częste stosowanie leków poza zarejestrowanymi wskazaniami w opiece paliatywnej wynika z braku innych opcji, a także rozdźwięku pomiędzy praktyką kliniczną, brakiem danych klinicznych oraz treścią charakterystyk produktów leczniczych. Wnioski: Potrzebne są zmiany prawne w odniesieniu do stosowania leków na podstawie zaleceń klinicznych, a w szczególności procedur niezbędnych i niemających alternatywy.

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“…off-label-use, is common practice in palliative care. 1 Off-label drug use includes any type of drug use deviant from the authorisation label, such as indication, route of administration, dose or duration of treatment. 2 Various reasons for off-label-use are reported with the lack of labelled alternatives mentioned most common.…”

Section: Introductionmentioning

confidence: 99%

“…2 Various reasons for off-label-use are reported with the lack of labelled alternatives mentioned most common. 1 Off-label-use is both a risk and an opportunity: it potentially puts a patient at risk of an uninvestigated treatment but is also needed to advance treatment options and might even be superior to licenced alternatives in certain circumstances. The main aim should always be to identify the treatment with the highest benefit and the lowest risk potential for an individual patient in the current treatment context.…”

Section: Introductionmentioning

confidence: 99%

“…7 Both a systematic review with studies on off-label drug use in palliative care and a web-based survey of palliative care physicians in Germany identified the same topics named in the expert workshop. 1,8 Based on the increasing significance of off-label-use in palliative care and the challenges in medical practice regarding decision making and informed consent, formulating recommendations for off-labeluse is essential to increase the safety of drug therapy and thus patient safety. However, the development of recommendations for off-label-use requires a different approach compared to already existing recommendations for the treatment of symptoms in palliative medicine, e.g.…”

Section: Introductionmentioning

confidence: 99%

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

Rémi¹,

K²,

Hagemann³

et al. 2019

Preprint

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

Cited by 27 publications

References 22 publications

Medication use in aged care residents in the last year of life: A scoping review

Medication use in aged care residents in the last year of life: A scoping review

Off-label drug use in palliative care in Poland

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

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