Prescribing Antipsychotic Medications to Patients With Dementia: Boxed Warnings and Mitigation of Legal Liability

Rose, Rachel V.; Kass, Joseph S.

doi:10.1212/con.0000000000000701

Cited by 4 publications

(4 citation statements)

References 2 publications

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“…The preservation of patients’ rights in the contemporary healthcare system is more complicated than the linear process of medication administration and should consider the whole process of medicines management [ 77 , 78 ]. Patients’ rights should encompass the discussion of specific risks and benefits of proposed therapy with patients or their guardians and the documentation of informed consent to medicine administration in the medical record [ 79 ].…”

Section: Discussionmentioning

confidence: 99%

A Systematic Review of the Legal Considerations Surrounding Medicines Management

et al. 2021

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Background and Objectives: There is a paucity of integrated knowledge regarding legal considerations required to ensure patient safety through safe medicines management. This study explores the legal considerations surrounding medicines management, providing a synthesis of existing knowledge. An integrative systematic review of the current international knowledge was performed. Materials and Methods: The search encompassed the online databases of PubMed (including Medline), Scopus, CINAHL, and Web of Science using MeSH terms and relevant keywords relating to the legal considerations of medicines management in healthcare settings. Results: The search process led to the identification of 6051 studies published between 2010 and 2020, of which six articles were found to be appropriate for data analysis and synthesis based on inclusion criteria. Research methods were varied and included qualitative interviews, mixed-methods designs, retrospective case reports and cross-sectional interrupted time-series analysis. Their foci were on the delegation of medicines management, pharmacovigilance and reporting of adverse drug reactions (ADRs) before and after legislation by nurses, physicians and pharmacists, medico-legal litigation, use of forced medication and the prescription monitoring program. Given the heterogenicity of the studies in terms of aims and research methods, a meta-analysis could not be performed and, therefore, our review findings are presented narratively under the categories of ‘healthcare providers’ education and monitoring tasks’, ‘individual and shared responsibility’, and ‘patients’ rights’. Conclusion: This review identifies legal aspects surrounding medicines management, including supervision and monitoring of the effects of medicines; healthcare providers’ knowledge and attitudes; support and standardised tools for monitoring and reporting medicines’ adverse side effects/ADRs; electronic health record systems; individual and shared perceptions of responsibility; recognition of nurses’ roles; detection of sentinel medication errors; covert or non-voluntary administration of medication, and patient participation.

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Section: Discussionmentioning

confidence: 99%

A Systematic Review of the Legal Considerations Surrounding Medicines Management

et al. 2021

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“…Furthermore, most antipsychotics have an EMA warning on the increased risk of death in people with dementia. 38 This warning was issued on the basis of observational long-term studies showing a higher risk for a number of conditions (including infections, cerebrovascular events, and overall risk of death) 39 ; however mortality was not increased in the included short-term studies. 30,31,34,37 Similarly, acceptability (total dropouts), 27,29 tolerability (dropouts due to adverse events), 29 and overall adverse events were not increased, 28,34 although for risperidone and olanzapine a higher risk of cerebrovascular events in people with dementia was found in short-term studies (⩽10 weeks).…”

Section: Discussionmentioning

confidence: 99%

Pharmacological treatment of hyperactive delirium in people with COVID-19: rethinking conventional approaches

Ostuzzi

Gastaldon

Papola

et al. 2020

Therapeutic Advances in Psychopharmacology

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People with coronavirus disease (COVID-19) might have several risk factors for delirium, which could in turn notably worsen the prognosis. Although pharmacological approaches for delirium are debated, haloperidol and other first-generation antipsychotics are frequently employed, particularly for hyperactive presentations. However, the use of these conventional treatments could be limited in people with COVID-19, due to the underlying medical condition and the risk of drug–drug interactions with anti-COVID treatments. On these premises, we carried out a rapid review in order to identify possible alternative medications for this particular population. By searching PubMed and the Cochrane Library, we selected the most updated systematic reviews of randomised trials on the pharmacological treatment of delirium in both intensive and non-intensive care settings, and on the treatment of agitation related to acute psychosis or dementia. We identified medications performing significantly better than placebo or haloperidol as the reference treatment in each population considered, and assessed the strength of association according to validated criteria. In addition, we collected data on other relevant clinical elements (i.e. common adverse events, drug-drug interactions with COVID-19 medications, daily doses) and regulatory elements (i.e. therapeutic indications, contra-indications, available formulations). A total of 10 systematic reviews were included. Overall, relatively few medications showed benefits over placebo in the four selected populations. As compared with placebo, significant benefits emerged for quetiapine and dexmedetomidine in intensive care unit (ICU) settings, and for none of the medications in non-ICU settings. Considering also data from indirect populations (agitation related to acute psychosis or dementia), aripiprazole, quetiapine and risperidone showed a potential benefit in two or three different populations. Despite limitations related to the rapid review methodology and the use of data from indirect populations, the evidence retrieved can pragmatically support treatment choices of frontline practitioners involved in the COVID-19 outbreak, and indicate future research directions for the treatment of delirium in particularly vulnerable populations.

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“…Use of conventional and atypical neuroleptics should be avoided, if possible, because of evidence for increased morbidity and mortality in patients with dementia, 71,72 leading to a class-wide US Food and Drug Administration (FDA) boxed warning. For more information on the boxed warning on antipsychotic medication use in dementia, refer to the article "Prescribing Antipsychotic Medications to Patients With Dementia: Boxed Warnings and Mitigation of Legal Liability" by Rachel V. Rose, JD, MBA, and Joseph S. Kass, MD, JD, FAAN, 73 in this issue of Continuum. Benzodiazepines should be avoided because of their sedating effects and the potential for further worsening cognition.…”

Section: Commentmentioning

confidence: 99%

Late-onset Alzheimer Disease

Rabinovici¹

2019

CONTINUUM: Lifelong Learning in Neurology

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PURPOSE OF REVIEW: Alzheimer disease (AD) is the most common cause of late-onset dementia. This article describes the epidemiology, genetic and environmental risk factors, clinical diagnosis, biomarkers, and treatment of late-onset AD, defined by age of onset of 65 years or older.RECENT FINDINGS: An estimated 5.7 million Americans are living with AD dementia, with the number of affected individuals growing rapidly because of an aging population. Vascular risk factors, sleep disorders, and traumatic brain injury are associated with an increased risk of AD, while increased cognitive and physical activity throughout the lifespan reduce the risk of disease. The primary genetic risk factor for late-onset AD is the apolipoprotein E (APOE) ε4 allele. AD typically presents with early and prominent episodic memory loss, although this clinical syndrome is neither sensitive nor specific for underlying AD neuropathology. Emerging CSF and imaging biomarkers can now detect the key neuropathologic features of the disease (amyloid plaques, neurofibrillary tangles, and neurodegeneration) in living people, allowing for characterization of patients based on biological measures. A comprehensive treatment plan for AD includes use of symptomatic medications, optimal treatment of comorbid conditions and neuropsychiatric symptoms, counseling about safety and future planning, and referrals to community resources.

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Prescribing Antipsychotic Medications to Patients With Dementia: Boxed Warnings and Mitigation of Legal Liability

Cited by 4 publications

References 2 publications

A Systematic Review of the Legal Considerations Surrounding Medicines Management

A Systematic Review of the Legal Considerations Surrounding Medicines Management

Pharmacological treatment of hyperactive delirium in people with COVID-19: rethinking conventional approaches

Late-onset Alzheimer Disease

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