Off-Label Use of Drugs and Medical Devices: A Review of Policy Implications

2012 ◽  
Vol 91 (5) ◽  
pp. 920-925 ◽  
Author(s):  
R S Stafford
Keyword(s):  
Medical Devices ◽  
Policy Implications ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Medical Liability for Off Label Use of Drugs in Romania

2018 ◽  
Vol 69 (3) ◽  
pp. 755-757
Author(s):  
Ionut Vida Simiti
Keyword(s):  
Side Effects ◽  
Medical Devices ◽  
Medical Liability ◽  
Criminal Offence ◽  
Off Label Use ◽  
National Agency ◽  
Off Label ◽  
Scientific Support ◽  
The Common ◽  
Label Use

Breaking the limits of the risks for the human body, health or even the life of the patient, as assumed by the pharmaceutical producers, by using a drug off label, for its side effects, in another purpose or even against the purpose for which the drug was authorized by the National Agency of Medicine and Medical Devices, is not in itself illegal if the off label use has the common consent of both the doctor and the patient for a treatment and only for a treatment which, although a spread procedure, has little or no scientific support. But if the patient is subjected to unreasonable risks, endangering his body, health or life beyond the possible benefits of the treatment, without being informed about the lack of scientific support, the doctor is liable not only for malpractice (civil medical liability) but also for a criminal offence.

scholarly journals Outcomes Associated with the Off-label Use of Medical Devices in Congenital Heart Disease at a Single Institute

2017 ◽  
Vol 47 (4) ◽  
pp. 509
Author(s):  
Young Hwa Kong ◽  
Jinyoung Song ◽  
Jun Huh ◽  
I-Seok Kang
Keyword(s):  
Congenital Heart Disease ◽  
Heart Disease ◽  
Medical Devices ◽  
Congenital Heart ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Off-label use of interventional medical devices.

1999 ◽  
Vol 173 (3) ◽  
pp. 539-542 ◽  
Author(s):  
J J Smith ◽  
L Berlin
Keyword(s):  
Medical Devices ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

scholarly journals Off-Label Use of Medical Devices in Children

PEDIATRICS ◽  
2016 ◽  
Vol 139 (1) ◽  
pp. e20163439 ◽  
Author(s):  
◽  
Keyword(s):  
Medical Devices ◽  
Off Label Use ◽  
Off Label ◽  
Label Use
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