Aligning quality of life and guidelines for off-label psychotropic drugs in adults with intellectual disabilities and challenging behaviour

Abstract

Introduction

Adults with intellectual disabilities have an increased vulnerability to mental health problems and challenging behaviour. In addition to psychotherapeutic or psychoeducational methods, off-label pharmacotherapy, is a commonly used treatment modality.

Objective

The aim of this study was to establish evidence-based guideline recommendations for the responsible prescription of off-label psychotropic drugs, in relation to Quality of Life (QoL).

Method

A list of guidelines was selected, and principles were established based on international literature, guideline review and expert evaluation. The Delphi method was used to achieve consensus about guideline recommendations among a 58-member international multidisciplinary expert Delphi panel. Thirty-three statements were rated on a 5-point Likert-scale, ranging from totally disagree to totally agree, in consecutive Delphi rounds. When at least 70% of the participants agreed (score equal or higher than 4), a statement was accepted . Statements without a consensus were adjusted between consecutive Delphi rounds based on feedback from the Delphi panel.

Results

Consensus was reached on 4 general:the importance of non-pharmaceutical treatments, comprehensive diagnostics and multidisciplinary treatment. Consensus was reached in 4 rounds on 29 statements. No consensus was reached on 4 statements concerning: freedom-restricting measures, the treatment plan, the evaluation of the treatment plan, and the informed consent.

Conclusion

The study led to recommendations and principles for the responsible prescription – aligned with the QoL perspective – of off-label psychotropic drugs for adults with intellectual disabilities and challenging behaviour. Extensive discussion is needed regarding the issues on which there was no consensus to furthering the ongoing development of this guideline.

Keywords:

• quality of life
• psychotropic drugs
• intellectual disability
• off-label use
• guidelines
• challenging behaviour
• Delphi study

Acknowledgements

This publication was authored by Pauline Laermans, Filip Morisse, Marco Lombardi, Sylvie Gérard, Stijn Vandevelde, Gerda de Kuijper, Kurt Audenaert and Claudia Claes. All authors declare that they have no conflicts of interest. This article has been written as part of a scientific advisory report by the Superior Health Council on the use of off-label psychotropic drugs for adults with intellectual disabilities. The authors were members of the ad hoc working group and sincerely thank the other members of the group (Godelieve Baetens, Gunther Degraeve and Eric Willaye).The research was made possible by the support of EQUALITY ResearchCollective and Scientific Foundation Mental Health Care Organisation Brothers of Charity. We would like to thank the members of the Scientific Steering Committee for their advice and the theory and practice elements in this study. We are also grateful to the national and international participants of the Delphi study for their time and input.

Disclosure statement

No potential conflict of interest was reported by the authors.