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International Journal of Clinical Pharmacy

, Volume 40, Issue 3, pp 509–512 | Cite as

Off-label and unlicensed prescribing in Europe: implications for patients’ informed consent and liability

  • Lise AagaardEmail author
  • Kent Kristensen
Commentary

Abstract

This article reviews the implications of off-label (OL) and unlicensed (UL) medicine use with respect to the legal duty to inform patients and the liability for failure to provide the patient with adequate information on benefits and risks. Informed consent is a legal prerequisite to any medical treatment and requires the physician to inform the patient about benefits and risks important for the patient’s decision. Since OL/UL medicine use is common in all fields of medical practice, physicians must be aware of the stricter requirements for information of the patient. The UK High Supreme Court ruled in the case Montgomery v. Lanarkshire Health Board that physicians’ information duty is not limited to the level of information that the physician finds important, but to what the patient deems important. In general, violations of the rule of informed consent does not constitute a physical injury, and patients can only claim compensation for damages, if adequate disclosure had been given, and its likely, that patients would have either rejected or opted for an alternative treatment.

Keywords

Informed consent Liability Medicine use Off-label prescribing Patient information Unlicensed prescribing 

Notes

Funding

None.

Conflicts of interest

The authors declare that they have no conflict of interest.

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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Havemann Law FirmCopenhagenDenmark
  2. 2.Institute of Law, University of Southern DenmarkOdenseDenmark

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