Types of Off-Label Drug Use and Informed Consent Doctrine When Prescribing Them

Types of Off-Label Drug Use and Informed Consent Doctrine When Prescribing Them
M. Drogovoz, V. M. Khomenko, V. V. Krynychko, M. Barus, A. Kovpak, M. O. Ostapets, T. O. Artiukh
Pharmacology Online, 2021; 3
Open Access
Today, medicine does not have a sufficient arsenal of drugs for the personalized treatment of cancer, neurological, psychiatric, pediatric patients, HIV-infected patients. An important aspect of informed consent when prescribing drugs off label is informing patients about potentially unknown risks, as well as about the existence of a rationale for such prescription of the drug. Thus, the doctrine of informed consent means, on the one hand, the doctor provides the patient with complete information about the use of an off label drug, an alternative method of treatment, the risks and potential benefits of such an alternative, and on the other hand, the patient decides whether he is ready to be treated with a drug that will be used off label, and confirms this with informed consent. In modern good medical practice, the patient’s rights take precedence over the opinion of the medical practitioner. Informed consent is an integral component of the modern relationship between doctors and their patients and a means of ensuring that the doctor’s beliefs do not override the patient’s right to self-determination and personal integrity.

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