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 The Off-Label Use of Antineoplastics in Oncology Is Limited But Has Notable Scientific Support in a University Hospital Setting

2019 ◽  
Vol 10 ◽  
Author(s):  
Marta Herrero Fernandez ◽  
Raquel Molina Villaverde ◽  
Monica Arroyo Yustos ◽  
Fatima Navarro Expósito ◽  
Jose Luis Lopez Gonzalez ◽  
...  
Keyword(s):  
Hospital Setting ◽  
University Hospital ◽  
Off Label Use ◽  
Off Label ◽  
Scientific Support ◽  
Label Use

scholarly journals A RETROSPECTIVE STUDY: THE OFF-LABEL USE OF ANTICONVULSANTS AT A PRIVATE HOSPITAL IN INDONESIA

2018 ◽  
Vol 10 (5) ◽  
pp. 119
Author(s):  
Bangunawati Rahajeng ◽  
Zullies Ikawati ◽  
Tri Murti Andayani ◽  
Iwan Dwiprahasto
Keyword(s):  
Medical Records ◽  
Private Hospital ◽  
Descriptive Analysis ◽  
Food Control ◽  
Off Label Use ◽  
National Agency ◽  
Off Label ◽  
Retrospective Data Collection ◽  
One Year ◽  
Label Use

Objective: Anticonvulsant is one class of drugs often used off-label. This study was conducted to investigate the prevalence and the indication of the off-label use of anticonvulsants in a private hospital in Java, Indonesia.Methods: This was an observational study with a retrospective data collection in a private hospital in Java. Data were obtained on the prescription of anticonvulsants. Indications of the use of anticonvulsants were obtained from the medical records of patients who were prescribed anticonvulsants. The off-label use of anticonvulsants was defined a prescribing of medication outside the indication approved by The National Agency of Drug and Food Control Indonesia (NA-DFC). The use off-label of anticonvulsants was calculated by descriptive analysis and presented as a percentage.Results: It showed that in one year there were 5,310 for 1,316 patients: of this 462 patients (35.11%) were for an off-label use. The anticonvulsants used off-label were oxcarbazepine 67.27% (37/55), carbamazepine 46.15% (54/117), pregabalin45.45% (60/132), phenytoin37.62% (225/598), valproate 25.34% (37/109), and gabapentin 18.28% (49/219). The highest off-label use of anticonvulsants was found in neurological and psychiatric disorders 67.32% (n=311), and on 97.19% of them were not supported by strong clinical evidence.Conclusion: The off-label use of anticonvulsants occurred in one-third of patients receiving prescriptions of anticonvulsants, even though for most of them there was a lack of evidence. More attention must be paid to the efficacy and risk of side effects of the drug used.

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

scholarly journals THE OFF- LABEL USE OF CARBAMAZEPINE IN INDONESIA

2018 ◽  
Vol 11 (5) ◽  
pp. 64
Author(s):  
Bangunawati Rahajeng ◽  
Zullies Ikawati ◽  
Tri Murti Andayani ◽  
Iwan Dwiprahasto
Keyword(s):  
Neuropathic Pain ◽  
Depressive Disorders ◽  
Descriptive Study ◽  
Off Label Use ◽  
National Agency ◽  
Cross Sectional ◽  
Off Label ◽  
Essential Step ◽  
Manic Depressive ◽  
Label Use

 Objective:. In Indonesia, carbamazepine was approved by The National Agency of Drugs And Foods Controls for the prophylaxis of lithium unresponsive manic-depressive disorders, all types of epilepsy (except for petit mal), and trigeminal neuralgia. This study was conducted to determine the off-label use of carbamazepine in Indonesia.Methods: This research is a nonexperimental descriptive study with a cross-sectional method. Data collection retrospectively by taking all patients that were prescribed carbamazepine in 2014. Data were obtained from four general hospitals in Yogyakarta. The off-label use of carbamazepine was defined a prescribing of carbamazepine outside the indication that approved by The National Agency for Drugs And Foods Controls of Republic of Indonesia (NA-DFC).Results: The use of carbamazepine in 2014 were 704 prescriptions, and on 251 (35.6%) of them were off-label drug use. The off-label use of carbamazepine were 149 prescriptions (59.4%) for neuropathic pain, 83 prescriptions (33.0%) for nociceptive pain, and 19 prescriptions (7.6%) for other indications.Conclusion: The mostly off-label use of carbamazepine in Indonesia was in neuropathic pain with low evidence. Further research to study the efficacy and the risk of off-label use of carbamazepine may be an essential step toward defining the potential for such purpose.

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