A snapshot of the prescribing patterns and off‐label use of gabapentinoid agents in tertiary care: a retrospective, cross‐sectional, descriptive study

Author(s):  
Felicity H. Prior
Author(s):  
Bangunawati Rahajeng ◽  
Zullies Ikawati ◽  
Tri Murti Andayani ◽  
Iwan Dwiprahasto

 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.


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

2021 ◽  
pp. postgradmedj-2021-140991
Author(s):  
Willem Andries Nienaber Louw ◽  
Ryan Alroy Davids

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.


BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e026076 ◽  
Author(s):  
François Drogou ◽  
Allison Netboute ◽  
Joris Giai ◽  
Xavier Dode ◽  
David Darmon ◽  
...  

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.


2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Mohd Masnoon Saiyed ◽  
Tarachand Lalwani ◽  
Devang Rana

Background. In the absence of standard pediatric prescribing information, clinicians often use medicines in an off-label way. Many studies have been published across the globe reporting different rates of off-label use. There is currently no study based on Indian drug formulary.Methods. The prospective observational study included pediatric patients in ages between 0 and 12 years admitted in a tertiary care hospital. Off-label use was assessed using the National Formulary of India (NFI). Predictors of off-label use were determined by logistic regression.Results. Of the 1645 medications prescribed, 1152 (70%) were off-label based on 14 possible off-label categories. Off-label medicines were mainly due to dose difference and use in restricted age limits as indicated in NFI. Respiratory medicines (82%), anti-infectives (73%), and nervous system medicines (53%) had higher off-label use. Important predictors of off-label prescribing were pediatric patients in age of 0 to 2 years (OR 1.68, 95% CI;P<0.001) and hospital stay of six to 10 days (OR 1.91, 95% CI;P<0.001).Conclusion. Off-label prescribing is common among pediatric patients. There is need to generate more quality data on the safety and efficacy of off-label medicines to rationalize pediatric pharmacotherapy.


Brain Injury ◽  
2014 ◽  
Vol 29 (4) ◽  
pp. 508-516 ◽  
Author(s):  
Federica Edith Pisa ◽  
Giorgia Cosano ◽  
Manuela Giangreco ◽  
Tullio Giorgini ◽  
Emanuele Biasutti ◽  
...  

BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S63-S64
Author(s):  
Ala Abdelgadir ◽  
Richard Walsh ◽  
Elizabeth Walsh ◽  
Sonn Patel

AimsQuetiapine is an atypical anti-psychotic medication licensed for the treatment of schizophrenia, bipolar disorder and adjunctive use in major depressive disorder. It's off-label use in low doses is increasing, possibly due to its sedative qualities, tolerability, low risk of extrapyramidal symptoms and to limit the unnecessary use of benzodiazepines. However, previous research highlights the risk of metabolic consequences even in low doses. Our aim is to establish the prescribing patterns and off-label use of quetiapine within a complete comminity mental health team population (CMHT).MethodThe GR1 CMHT provides care to a population of 25,000 people in a mixed urban and rural area. Multi-disciplinary case notes for all registered patients were reviewed for a one-year period. A database was created to include sociodemographic details, diagnosis, and medication. The proportion of patients prescribed quetiapine was identified and the dosage divided into multiple increments. The team's consultant reviewed and verified all ICD-10 diagnoses. Quetiapine dose by diagnosis was examined using descriptive statistics.ResultOf 246 registered patients, 62 (25% of CMHT caseload) were prescribed Quetiapine. Quetiapine was prescribed across a range of disorders including psychotic 17 (27%), mood 18 (29%), anxiety 14 (22 %), personality disorders 11 (18%) and others 2 (3%). Doses spanned between 25 mg – 800 mg daily. 19 patients (31%) were prescribed less than 25 mg, 20 patients (32%) between 25 mg and 100 mg and 23 patients (37%) above 100 mg. In psychotic and mood disorders, dosage varied widely between the low and high range. Furthermore, of the psychotic disorders, 11 (65%) were prescribed a second antipsychotic medication. For diagnoses in which the prescribing indication was clearly off-label, the dosages were predominantly low (100 mg or less).ConclusionQuetiapine was commonly prescribed in our patient population. Its frequent off-label use in low doses suggests that its prescription was for its additional qualities. Our findings highlight the importance of assessing the risk-benefit profile for every patient given the potential side effects, involving patients in the consultation of its off-label use and appropriate monitoring.


2020 ◽  
pp. 001857872094222
Author(s):  
Aeshah AlAzmi ◽  
Zahra Alasmari ◽  
Consuela Yousef ◽  
Ahmed Alenazi ◽  
Mohammed AlOtaibi ◽  
...  

Objective: Prescribing a drug for a child is not an easy task and requires using the best available evidence as a guide, especially when a drug is used off-label. The practice of prescribing a drug for off-label use is fairly widespread worldwide. The FDA does not regulate prescribing patterns or practices of individual practitioners and, therefore, allows off-label use. The main objective of this study is to evaluate off-label prescribing among the pediatric population in the Kingdom of Saudi Arabia (KSA). Method: This is a retrospective, simple random selection observational study of children (≤15 years) who visited pediatric clinics and had at least 1 drug prescribed over a 12-month period (January to December 2018). Results: A total of 865 drugs (mean 1 and SD 0.24) were prescribed to 326 children. Off-label was identified in 39.4% of the drugs with a frequency of 512 (as 1 drug may belong to more than 1 off-label category). The most common reason for off-label prescribing was related to doses that were “higher or lower than the recommended use” (48.6%), and the most frequently identified drug class prescribed for off-label use was anti-infective drugs for systemic use (39.9%). The percentage of off-label drug use was found to be higher in girls and in the age group of 1 month to 2 years ( P = .001) for both variables. In addition, a significant association was found between off label drug use and the total number of drugs prescribed, P < .001. Conclusion: The findings of this study showed a high incidence of off-label prescribing mainly related to dosing and indication. The results of this observational study support the need to establish a unified national pediatric dosing formulary guide to ensure safe drug use in pediatrics.


2017 ◽  
Vol 39 (4) ◽  
pp. 860-866
Author(s):  
Muhammad Aamir ◽  
Jamshaid Ali Khan ◽  
Faisal Shakeel ◽  
Syed Muhammad Asim

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