ORCID Profile
0000-0001-8424-7729
Current Organisation
Tengku Ampuan Rahimah Hospital
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Publisher: Elsevier BV
Date: 11-2017
Publisher: Springer Science and Business Media LLC
Date: 14-09-2018
DOI: 10.1007/S12519-018-0186-Y
Abstract: In the past two decades, many legislative and regulatory initiatives were taken globally to improve drug use in children. However, children are still found to be prescribed with off-label drugs. This study was conducted to provide an overview of the worldwide trend in off-label prescribing in children from the year 1996 to 2016. The articles published in PubMed, MEDLINE and Google Scholar were searched using text words: off-label, unlicensed, paediatric and children. Additional articles were identified by reviewing the bibliography of the retrieved articles. Full-text articles published in English which reported on the prevalence of off-label prescribing in children between January 1996 and December 2016 were included. A total of 101 studies met the inclusion criteria. Off-label prescribing definition included four main categories: age, indication, dose and route of administration. The three most common reference sources used in the studies were summary of product characteristics, national formularies and package inserts. Overall, the off-label prescribing rates in children ranged from 1.2 to 99.7%. The most common category of off-label prescribing in children was dose and age. This review highlighted that off-label prescribing in children was found to be highly prevalent throughout the past two decades, persistently in the neonatal intensive care units. This suggests that besides legislative and regulatory initiatives, behavioural, knowledge aspects and efforts to integrate evidence into practice related to off-label prescribing also need to be evaluated and consolidated as part of the concerted efforts to narrow the gaps in prescribing for children.
Publisher: Elsevier BV
Date: 05-2017
DOI: 10.1016/J.SAPHARM.2016.06.014
Abstract: The pediatric population is an enormously erse segment of population varying both in size and age. The ersity caused pharmacists face various challenges primarily related to procuring, provision as well as use of drugs in this group of patients. Pediatric dose calculation is particularly a concern for pharmacists. Another challenge faced by pharmacists is unavailability of suitable formulations for pediatric use. This has also led many pharmacists to prepare extemporaneous liquid preparations, even though stability data on such preparations are scarce. Some extemporaneous preparations contain excipients which are potentially harmful in children. Besides that, inadequate labeling and drug information for pediatric drug use had not only challenged pharmacists in recommending and optimizing drug use in children, but also inadvertently caused many drugs used outside the approved terms of the product license (off-label use). Pharmacists are striving to stay connected to overcome the common and comparable challenges faced in their day to day duties and strive to maximize the safe and effective use of medicines for children.
Publisher: Springer Science and Business Media LLC
Date: 13-06-2019
DOI: 10.1007/S11096-019-00862-Y
Abstract: Background Off-label prescribing in children is associated with several prerequisites such as ensuring sound and scientific evidence and obtaining written consent prior to use of off-label drugs to ensure that protection is provided to patients and healthcare professionals. Adherence to the pre-requisites depends on the attitude, views and knowledge of the pharmacists and doctors involved in this practice. Objective To explore the attitudes, knowledge and views on off-label prescribing in children among hospital-based pharmacists and paediatric doctors. Setting The study was conducted in a 620-bedded general hospital located in the urban area of central Peninsular Malaysia. Method Face to face, semi-structured interviews with 12 pharmacists and 12 paediatric doctors. Interviews were audio-recorded, transcribed and analysed using constant comparison method. Main outcome measure Themes surrounding hospital-based pharmacists' and paediatric doctors' attitude, knowledge and views on off-label prescribing in children. Results Four themes were derived: knowledge on off-label prescribing in children, views on off-label prescribing in children, attitude towards off-label prescribing in children and guidance on off-label prescribing in children. Conclusion There is a need to increase the knowledge of hospital-based pharmacists and paediatric doctors and address several concerns on off-label prescribing in children. The decision to prescribe or dispense off-label drugs involved collective decision-making mechanisms and guidance is required with regards to offlabel prescribing in children.
No related grants have been discovered for Shamala Balan.