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

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.

journal_name

Int J Clin Pharm

authors

Aagaard L,Kristensen K

doi

10.1007/s11096-018-0646-4

subject

Has Abstract

pub_date

2018-06-01 00:00:00

pages

509-512

issue

3

eissn

2210-7703

issn

2210-7711

pii

10.1007/s11096-018-0646-4

journal_volume

40

pub_type

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