title: 'He was like a zombie': off-label prescription of antipsychotic drugs in dementia.
abstract: This paper explores the legal position of the off-label prescription of antipsychotic medications to people with dementia who experience behavioural and psychological symptoms of dementia (BPSD). Dementia is a challenging illness, and BPSD can be very difficult for carers to manage, with evidence that this contributes to carer strain and can result in the early institutionalisation of people with dementia. As a result, the prescription of antipsychotic and other neuroleptic medications to treat BPSD has become commonplace, in spite of these drugs being untested and unlicensed for use to treat older people with dementia. In recent years, it has become apparent through clinical trials that antipsychotic drugs increase the risk of cerebrovascular accident (stroke) and death in people with dementia. In addition, these types of medication also have other risk factors for people with dementia, including over-sedation and worsening of cognitive function. Drawing on recent questionnaire (n = 185), focus group (n = 15), and interview (n = 11) data with carers of people with dementia, this paper explores the law relating to off-label prescription, and the applicability of medical negligence law to cases where adverse events follow the use of antipsychotic medication. It is argued that the practice of off-label prescribing requires regulatory intervention in order to protect vulnerable patients.
authors.affiliation: 1 University of Birmingham.
authors.forename: Rosie
authors.initials: R
authors.lastname: Harding
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Peel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D032763:Behavior Control / Q000379:methods; D017028:Caregivers / Q000523:psychology; D003704:Dementia / Q000188:drug therapy* / Q000523:psychology; D017007:Duty to Warn / Q000331:legislation & jurisprudence; D005260:Female; D017144:Focus Groups; D006801:Humans; D008297:Male; D008318:Malpractice / Q000331:legislation & jurisprudence; D008875:Middle Aged; D056687:Off-Label Use / Q000331:legislation & jurisprudence; D011795:Surveys and Questionnaires; D006113:United Kingdom
chemical_list: D014150:Antipsychotic Agents