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.

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 Medication-Use Evaluation of Recombinant Human Factor VIIa

2020 ◽  
Vol 3 (2) ◽  
pp. 38-43 ◽  
Author(s):  
Abrar Al-Subhi ◽  
Mansoor Ahmed Khan ◽  
Mohammed A. Aseeri
Keyword(s):  
Human Factor ◽  
Hemophilia A ◽  
Factor Viia ◽  
Medication Use ◽  
Off Label Use ◽  
Off Label ◽  
Medical City ◽  
One Year ◽  
The Cost ◽  
Label Use

ABSTRACT Introduction Medication-use evaluation (MUE) is a performance improvement method used to achieve optimal patient outcomes. The recombinant human factor VIIa (rFVIIa) (NovoSeven) is an expensive agent approved by the U.S. Food and Drug Administration (FDA) for specific indications. However, in clinical practice, rFVIIa is often used for conditions unrelated to the one approved, with limited evidence. The use of rFVIIa has been associated with expenditures of more than Saudi riyal (SR)30 million ($8 million) annually at King Abdul-Aziz Medical City-Western Region (KAMC-WR). Therefore, we planned a MUE of rFVIIa. The primary purpose was to determine the off-label use of rFVIIa, and the secondary purpose was to evaluate the cost impact of off-label use of rFVIIa at KAMC-WR. Methods This was an observational retrospective cohort study conducted to assess the off-label usage pattern and the direct cost of rFVIIa for one year. Results A total of 27 patients who received rFVIIa were included. Two out of the 27 patients had hemophilia A with inhibitors (7%), and 23 of the 27 patients received rFVIIa with off-label indications (85%). The total cost associated with the use of rFVIIa was SR18.61 million ($4.96 million). The cost of the rFVIIa used for the appropriate purpose was SR17.83 million ($4.75 million), which represented 95.8% of the expenditures. Conclusions Recombinant FVIIa is one of the most expensive medications in our hospital. It has been used mostly in patients having hemophilia A with inhibitors.

Abstract 2563: Off Label Use Of Sirolimus Eluting Stent Increases The Rate Of Death And Stent Thrombosis Without Jeopardizing The Efficacy: Result Of The Evastent Matched Corhort Registry

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Aude Boignard ◽  
Alison Foote ◽  
Jean Louis Quesada ◽  
Mohamed Sahnoun ◽  
Nicolas Danchin ◽  
...  
Keyword(s):  
Stent Thrombosis ◽  
Safety Concern ◽  
Diabetic Patients ◽  
Off Label Use ◽  
Off Label ◽  
Risk Of Death ◽  
Sirolimus Eluting Stent ◽  
One Year ◽  
The One ◽  
Label Use

In everyday practice the off label use of DES is widespread, but are SES as effective in reducing the need for revascularisation when used on-label and do certain types of off-label use raise greater safety concerns? The EVASTENT nationwide matched cohort registry was designed to assess the efficacy and safety of the SES in diabetic patients with single or multiple vessel disease (SVD and MVD) compared to non-diabetic patients. 1731 pts were included (844 diabetic and 730 MVD patients). Although on-label use of SES was required patients presenting with various categories of off-label lesions were included. 428 (24% ) patients included and 514/ 2730 lesions (19%) treated were off-label: bifurcation lesions (n=182), lesions with thrombus (n=139), highly calcified lesions (n=134), ostial lesions (n=102), very long (>30 mm) lesions (n=15), left-main stenosis n=11), EF<0.30 (n=7). In 73 cases the lesion was off-label for more than one reason. Complete interim one year follow-up data are available for 98% of the patients and in October 2007 most patients will have been followed for 3 years. All MACES (cardiac death, non-fatal myocardial infarction and Stent thrombosis ST) have been evaluated by an independent critical events committee and cases of ST have been classified according to the ARC criteria. Results: off-label use was not more frequent in diabetic patients but occurred more often in MVD patients. Table 1 shows the one-year comparison between on and off-label use. Subgroup analysis suggests that highly calcified, bifurcation and ostial lesions are particularly at risk for ST. In multivariate analysis off-label use remained an independent predictor of death and the occurrence of MACEs. Conclusion: Off-label use of SES does not reduce the efficacy of the SES, but increases the risk of death and ST. This safety concern must be taken into consideration when designing studies to evaluate new indications for these DES. On and Off-Label comparison

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.

scholarly journals An overview of the use of Carbamazepine at PKU Muhammadiyah Hospital Yogyakarta

2020 ◽  
Vol 11 (SPL4) ◽  
Author(s):  
Bangunawati Rahajeng ◽  
Sabtanti Harimurti
Keyword(s):  
Neuropathic Pain ◽  
Trigeminal Neuralgia ◽  
Off Label Use ◽  
Diabetic Neuropathic Pain ◽  
National Agency ◽  
Cross Sectional ◽  
Off Label ◽  
Manic Depressive ◽  
Cross Sectional Design ◽  
Label Use

Carbamazepine is often used for indications other than epilepsy. In Indonesia, carbamazepine is registered for prophylaxis for lithium-responsive manic depressive disease, antiepilepsy, epilepsy of all types (except petit mal), and trigeminal neuralgia. This research aimed to describe the use of carbamazepine at PKU Muhammadiyah Hospital Yogyakarta. This was an observational study with a cross-sectional design. The data were taken retrospectively from the medical records of patients who received carbamazepine during 2014. The use of carbamazepine included 494 prescriptions given to 117 patients. The physician who most prescribed carbamazepine was a neurologist (63.04%). The most appropriate use of carbamazepine following the National Agency for Drugs And Foods Controls of Republic of Indonesia (NA-DFC) was for epilepsy (34.19%), followed by trigeminal neuralgia (6.84%) and bipolar disorder (4.27%). The most off-label use was in cases of stroke (7.69%), followed by diabetic neuropathic pain, herniated nucleus pulposus, and cephalgia (all 3.42%). Evidence found for the off-label use of carbamazepine was in diabetic neuropathic pain and neuropathic pain post-stroke (24.53%). The use of carbamazepine at PKU Muhammadiyah Yogyakarta hospital is mostly on-label, with some off-label use. The off-label use of carbamazepine (24.53%) has strong evidence, while some use has a lack of scientific support or no evidence at all. 

Indikationsfremde Anwendung von Medikamenten und Medizinprodukten in der Notfallmedizin

2019 ◽  
Vol 14 (04) ◽  
pp. 361-371
Author(s):  
Karl Peter Ittner ◽  
Joachim Koppenberg ◽  
Ute Walter
Keyword(s):  
Off Label Use ◽  
Off Label ◽  
Label Use

ZusammenfassungWenn zugelassene Arzneimittel außerhalb der in der entsprechenden Fachinformation dargelegten Beschreibungen angewendet werden, dann spricht man von einer nicht zulassungskonformen Anwendung oder von einem Off-Label-Use. Wie in fast allen medizinischen Fachgebieten gibt es auch im Rettungsdienst sogenannte Off-Label-Use-Pharmakotherapien. Sofern evidenzbasierte Informationen zu einer nicht zulassungskonformen Anwendung vorliegen, und insbesondere im konkreten Notfall keine zulassungskonforme Möglichkeit besteht, dann ist diese gerechtfertigt. Verwendet ein Notarzt aber ein Medizinprodukt außerhalb der Zulassung, dann stellt er ein neues Produkt her und haftet persönlich bei einem Patientenschaden.

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