Balancing Burdens and Benefits: Ethical Issues of Off‐Label Prescription Pharmaceutical Use

Topic: Risk, prevention and care in population studies

He has even given a threshold outlining when the practice of medicine ends versus when the practice of unethical, non–institutional review board approved research begins. As a result, routine medicine becomes an impractical and unhelpful endeavor under these constraints which I do not consider ethical at all. He prescribes it most often for patients under age 65 years, which suggests that he is not using the drug for its sole FDA-approved indication, Alzheimer-type dementia. In these cases, we are correct to draw from our knowledge of analogous conditions that often have a greater research base simply due to a more economically favorable population for pharmaceutical and device We have a to of the information about the we and a to new treatment with our We have a to inform our patients and their about our level of in the we and we should encourage their in treatment effects versus effects. should that for more and evidence-based and more severe without standard can greater risk under informed that this of and individual medical practice an ethical a When will all the physicians the to back for a will us on of drugs for uses other than the for which the FDA has approved their use use of a drug to treat a than the one for which it was or to treat a such as using a drug for children when it was only in is widespread and for at of all prescriptions 1. not all such uses the the ethical by the routine off-label use of a drug by a single physician when such use has been as safe and through as the general standard of care for the in I on this of off-label use rather than on a physician who uses a drug off as a of treating a particular patient who has not responded to other because it was the in The Washington Post article in which I was quoted 2. also are by the and by the even more in which physicians prescribe a drug for an off-label use that has been through published in or that has of the of most or all physicians without a example, in the latter physicians may be prescribing the drug without that they are using it in a that has not been and approved by the FDA or without really the implications of prescribing on and off off-label use of drugs is questions as to whether this is good as of the law is that is to that a that its drug is safe and for the use that will be on its a sometimes the Once a drug has been for and the FDA has no to how physicians use whether in with the or a physician with the to use a drug in a when he or she has to believe that doing so

Key findings

• He has even given a threshold outlining when the practice of medicine ends versus when the practice of unethical, non–institutional review board approved research begins.
• As a result, routine medicine becomes an impractical and unhelpful endeavor under these constraints which I do not consider ethical at all.
• He prescribes it most often for patients under age 65 years, which suggests that he is not using the drug for its sole FDA-approved indication, Alzheimer-type dementia.
• In these cases, we are correct to draw from our knowledge of analogous conditions that often have a greater research base simply due to a more economically favorable population for pharmaceutical and device We have a to of the information about the we and a to new treatment with our We have a to inf

Why it matters

This paper discusses ethical issues of prescribing drugs off-label, including a drug prescribed for Alzheimer-type dementia outside its approved use. It does not report testing a treatment, cure, or prevention for Alzheimer's disease.

Study details

• Study designrandomized controlled trial
• Evidence strengthHigh

Read the original

• DOI: 10.1016/j.pmrj.2013.08.601
• PubMed: 24160301
• Original source →

May need a subscription OpenAlex found no free copy of the full text (checked 6 Feb 1020), so the publisher may charge for it. The PubMed abstract is free.

@article{vox2013-24160301,
  author  = {Vox, Ford and Capron, Alexander Morgan and Kraus, Marilyn F. and Alexander, G. Caleb and Kirschner, Kristi L.},
  title   = {{Balancing Burdens and Benefits: Ethical Issues of Off‐Label Prescription Pharmaceutical Use}},
  journal = {PM\&R},
  year    = {2013},
  doi     = {10.1016/j.pmrj.2013.08.601},
  pmid    = {24160301},
  url     = {https://doi.org/10.1016/j.pmrj.2013.08.601}
}

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