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Off-Label Prescribing in Older Patients

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Abstract

The practice of off-label prescribing, i.e. prescribing drugs either for unregistered/unapproved therapeutic indications and age groups or using unregistered/unapproved doses or methods of administration, is common in older patients. This may be due to the poor representation of this group in pre-marketing clinical trials assessing therapeutic efficacy and safety of novel therapies or merely to the fact that trials in a particular indication have not been undertaken. Off-label prescribing should not be viewed as scientifically or ethically unsound when there are good clinical data to support a particular therapeutic indication. However, a number of steps should be followed in order to ensure therapeutic efficacy, reducing, at the same time, the risk of adverse drug reactions and/or medical litigation. This article discusses the current epidemiology and trends in off-label prescribing in older patients, the scientific and ethical justification of this practice, medico-legal implications, and proposed strategies for risk mitigation.

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Acknowledgements

No sources of funding were used to assist in the preparation of this article. The authors have no conflicts of interest that are directly relevant to the content of this article.

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Authors and Affiliations

  1. Department of Clinical Gerontology, King’s Health Partners Academic Health Science Centre, Denmark Hill, London, SE5 9RS, UK

    Stephen H. D. Jackson

  2. Department of Geriatric Medicine and Expertise Centre of Pharmacotherapy for Old Persons, Utrecht University Medical Centre, Utrecht, The Netherlands

    Paul A. F. Jansen

  3. Division of Applied Medicine, University of Aberdeen, Aberdeen, UK

    Arduino A. Mangoni

Authors
  1. Stephen H. D. Jackson
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  2. Paul A. F. Jansen
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  3. Arduino A. Mangoni
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Correspondence to Stephen H. D. Jackson.

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Jackson, S.H.D., Jansen, P.A.F. & Mangoni, A.A. Off-Label Prescribing in Older Patients. Drugs Aging 29, 427–434 (2012). https://doi.org/10.2165/11633520-000000000-00000

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