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. 

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 Off-label use and harmful potential of drugs in a NICU in Brazil: A descriptive study

2016 ◽  
Vol 16 (1) ◽  
Author(s):  
Alcidésio Sales de Souza ◽  
Djanilson Barbosa dos Santos ◽  
Luís Carlos Rey ◽  
Marina Garruti Medeiros ◽  
Marta Gonçalves Vieira ◽  
...  
Keyword(s):  
Descriptive Study ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Prevalence of methylphenidate use by Master of Medicine students at a South African university

2021 ◽  
pp. postgradmedj-2021-140991
Author(s):  
Willem Andries Nienaber Louw ◽  
Ryan Alroy Davids
Keyword(s):  
South African ◽  
Undergraduate Students ◽  
Performance Enhancement ◽  
Off Label Use ◽  
Undergraduate Medical Students ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
Off Label ◽  
Significant Difference ◽  
Label Use

BackgroundMethylphenidate is mainly used for the treatment of attention-deficit/hyperactive-disorder (ADHD). Its effect of increased attentiveness leads to the potential of off-label use by students for academic enhancement—previously demonstrated in undergraduate students. No publication exists on postgraduate student use of methylphenidate.ObjectivesTo provide a summary of the self-reported prevalence and correlates of methylphenidate use in Masters of Medicine (MMed) students registered at the Faculty of Medical and Health Sciences of a South African university.MethodsA cross-sectional study was conducted. Data were collected via a self-administered anonymous online questionnaire distributed by email to 505 registered MMed students.ResultsOf the 253 responses (response rate 50.1%) received 71 (28.1%) have used methylphenidate. Only 2.4% have been diagnosed with ADHD. The majority (73.2%) obtained it without a formal medical consultation. Self-prescription (26.8%) and prescription by a colleague without consultation (23.9%) contributed significantly. Academic performance enhancement was the primary motivation for use in 71.8% and 42.3% of users started using methylphenidate while registered as an MMed student. There was no statistically significant difference in terms of gender (p=0.151), age (p=0.288) or year of study (p=0.149).ConclusionsOff-label use of methylphenidate is prevalent in MMed students registered at this South African university. The prevalence is significantly higher than in undergraduate medical students. The non-conventional means of access is of great concern. Efforts should be made to discourage self-prescription, educate students on the dangers of methylphenidate use, promote better access regulation and enhance psychological support.

scholarly journals Off-label drug prescriptions in French general practice: a cross-sectional study

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e026076 ◽  
Author(s):  
François Drogou ◽  
Allison Netboute ◽  
Joris Giai ◽  
Xavier Dode ◽  
David Darmon ◽  
...  
Keyword(s):  
General Practice ◽  
Drug Prescription ◽  
Low Frequency ◽  
Cross Sectional Study ◽  
Drug Prescriptions ◽  
Off Label Use ◽  
Sectional Study ◽  
Cross Sectional ◽  
Off Label ◽  
Label Use

ObjectivesOff-label drug prescribing is a public health and economic issue. The aim of this study was to describe off-label prescription in general practice in France, in terms of frequency and nature, and to identify its main determining factors.DesignMulticentre cross-sectional studySettingTwenty-three training general practice officesParticipantsAll the voluntary patients coming for a medical consultation or visited at home over a cumulative period of 5 days per office between November 2015 and January 2016.MethodsEleven interns, acting as observers, collected data. Two reviewers analysed the drugs prescribed by the trainers, in order to identify those prescribed off-label in terms of their indication or the age of the patient. We used a univariate, then a multivariate model, based on hierarchical mixed-effects logistic regression.ResultsAmong the 4932 drug prescriptions registered, 911 (18.5%[95% CI17.4% to 19.6%]) were off-label, of which 865 (17.6%) due to the indication of the drug and 58 (1.2%) due to the age of the patient. The prescription never mentioned the off-label use, neither was the patient informed of it, as required by the French law. With the multivariate analysis, variables contributing to off-label prescription were the number of drugs (OR=1.05 for each additional drug), the initiation of new drug therapy (OR=1.26) and the non-specific goal of the prescription (OR=1.43); the age of the patient ≤14 years (OR=1.42); the rural location of the physician’s practice (OR=1.38) and the low frequency of the visits of national health insurance representatives (OR=0.93).ConclusionAlmost one out of five drugs prescribed in French general practice was off-label. It seems necessary to better train physicians in clinical pharmacology, to provide them with more effective drug prescription software, to reinforce postmarketing surveillance and to clearly define off-label use by consensus.

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.

Prescribing practice and off-label use of psychotropic medications in post-acute brain injury rehabilitation centres: A cross-sectional survey

Brain Injury ◽  
2014 ◽  
Vol 29 (4) ◽  
pp. 508-516 ◽  
Author(s):  
Federica Edith Pisa ◽  
Giorgia Cosano ◽  
Manuela Giangreco ◽  
Tullio Giorgini ◽  
Emanuele Biasutti ◽  
...  
Keyword(s):  
Brain Injury ◽  
Psychotropic Medications ◽  
Acute Brain Injury ◽  
Off Label Use ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Injury Rehabilitation ◽  
Off Label ◽  
Prescribing Practice ◽  
Label Use

scholarly journals Prescription Pattern and Off-Label Use of Antipsychotics in a Middle Eastern Population

2021 ◽  
Vol 12 ◽  
Author(s):  
Kholoud Bastaki ◽  
Mohammed El Anbari ◽  
Suhaila Ghuloum ◽  
Puthen Veettil Jithesh
Keyword(s):  
Precision Medicine ◽  
Middle Eastern ◽  
Healthcare Providers ◽  
Outcome Data ◽  
Off Label Use ◽  
Cross Sectional ◽  
Prescription Pattern ◽  
Off Label ◽  
Number Of Patients ◽  
Label Use

Background: Understanding the prescription pattern of medications in a population can help reveal the potential usage scenarios, including off-label prescriptions, and the need for precision medicine implementation. Therefore, the aim of this study was to assess the prescription pattern and off-label use of antipsychotics in the Qatari population.Methods: We performed a cross-sectional study of Qatari patients who received antipsychotic prescriptions from the major healthcare providers in the country during the 2-year period between June 2018 and May 2020. The number of patients, prescriptions dispensed, and clinical indications were collected and statistical analysis using chi-square test was conducted.Results: Among the 9,349 Qatari patients prescribed with antipsychotics during the study period, the majority were female (57%; p < 0.001) and were in the age categories 20–39 and 30–39 years (both 22%; p < 0.001). Among the 35,938 antipsychotic prescriptions dispensed, second-generation antipsychotics were the most highly prescribed (59%), specifically, quetiapine (16%) and olanzapine (12%), but the first-generation antipsychotic prochlorperazine (13%) was also highly prescribed. Most of the indications of antipsychotics (69%) were for off-label use such as for controlling chronic diseases, sleeping disorders, benign paroxysmal positional vertigo and irritable bowel syndrome.Conclusion: Non-mental health and off-label prescriptions of several antipsychotics were observed. Integration of this data with pharmacogenomic and clinical outcome data will help in determining the course of action for implementing personalized and precision medicine in the country and beyond.

scholarly journals Peresepan Obat “Off-Label” Pada Anak Dengan Penyakit Infeksi Saluran Pernapasan Akut

2021 ◽  
Vol 2 (1) ◽  
pp. 94
Author(s):  
Oki Nugraha Putra ◽  
Eri Destin Anggraini ◽  
Ana Khusnul Faizah
Keyword(s):  
Tract Infection ◽  
Respiratory Tract ◽  
Respiratory Tract Infection ◽  
Prescription Drugs ◽  
Acute Respiratory Tract Infection ◽  
Off Label Use ◽  
Cross Sectional ◽  
Off Label ◽  
Tract Infections ◽  
Label Use

ABSTRAKInfeksi Saluran Pernapasan Akut (ISPA) termasuk penyakit yang banyak terjadi di Indonesia terutama pada usia anak. Pada populasi anak berisiko mendapatkan peresepan obat off-label dikarenakan terbatasanya data efikasi obat untuk anak. Penggunaan obat off-label meningkatkan risiko efek yang tidak dikehendaki. Penelitian ini bertujuan untuk mengevaluasi penggunaan obat secara off-label pada peresepan pasien ISPA anak. Penelitian ini merupakan penelitian deskriptif observasional dengan menggunakan desain cross-sectional. Pengumpulan data menggunakan peresepan obat dengan diagnosis ISPA  pada anak usia 0-18 tahun. Penelitian ini dilakukan pada bulan November 2019 sampai dengan Februari 2020. Pada` penelitian ini didapatkan 124 resep dengan diagnosis ISPA. Penggunaan obat off-label pada peresepan penyakit infeksi saluran pernapasan akut untuk pasien anak sebesar 23% dengan kategori off-label usia (15,67%), off-label dosis (5,70%), off-label rute pemberian (1,22%) dan off-label indikasi (0,40%). Jenis obat off-label paling banyak diresepkan untuk ISPA anak adalah antihistamin klorfeniramin maleat. Berdasarkan hasil penelitian yang telah dilakukan dapat disimpulkan bahwa penggunaan obat off-label pada penyakit ISPA anak cukup tinggi. Farmasis dan dokter dapat berkolaborasi untuk pemantauan penggunaan obat yang tergolong off-label. Penelitian lanjutan diperlukan untuk melihat korelasi atau faktor risiko yang berpotensi meningkatkan penggunaan off-label pada ISPA anak. Kata kunci : Obat off-label; ISPA; Peresepan; Anak. ABSTRACTAcute respiratory tract infections (ARTI) is a disease that often occurs in Indonesia, especially in children. The population of children is high risk of receiving off-label prescription drugs. The use of off-label drugs increases the risk of undesirable effects. This study was aimed to evaluate the off-label use of drugs in prescribing with acute respiratory tract infection. This research is a descriptive observational study using a cross-sectional design. Data was collected by the prescription in children aged 0-18 years old with acute respiratory tract infection. This study was conducted from November 2019 to February 2020. In this study, 124 prescriptions were obtained with a diagnosis of ARTI. The use of off-label drugs was 23% with the off-label age category (15.67%), off-label dose (5.70%), off-label route of administration (1.22%) and off-label indication (0.40%). The type of off-label drug most commonly prescribed in children with ARTI is chlorpheniramine maleate. It can be concluded that the use of off-label drugs in children with ARTI disease is quite high. Pharmacists and clinicians should collaborate each other to monitor the use of drugs that are classified as off-label. Further research is needed to analyze   correlations or risk factors that potentially may increase off-label use in children with ARTI.Keywords : Off-label drugs; Acute Respiratory Tract ; Infection; Prescribing; Children.

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