Abstract
BackgroundOff-label drug use is widespread in pediatric drug treatment, and the implementation of guidelines on this topic remains challenging. The objective of this study was to evaluate current practice and awareness of healthcare professionals towards pediatric off-label drug use, as well as the barriers to guideline implementation among pediatric healthcare professionals in Shanghai, China.MethodsA validated questionnaire was issued to representatives of pediatricians, pharmacists, nurses and administrators from hospitals with pediatric qualification in Shanghai.ResultsA total of 679 completed questionnaires from 69 hospitals were included in the analysis. Nearly half (47.9%) of the pediatricians acknowledged that they had prescribed off-label drugs. Most (88.4%) of the pharmacists acknowledged that they had dispensed off-label medicines. The main reason for off-label prescribing was the lack of pediatric dosage information. The most common category of off-label prescribing in children was dosage. Nearly half (42.0%) of the participating hospitals had developed internal protocols for off-label drug use. However, approximately half of the respondents reported that they did not adhere to the guidance and that it had barriers to implementation. Most respondents (84.5%) declared that they were familiar with the term “off-label drug use”. However, the awareness rate of the Chinese Expert Consensus of Pediatric Off-Label Drug Use was low (45.7%). More than half (55.4%) of the respondents declared that they did not adhere to the process proposed in the consensus and that barriers existed for its utilization.ConclusionsPediatric off-label drug use is widespread in Shanghai, China, and barriers exist to the implementation of the guideline. A legally recognized national guideline with a broad scope of application for off-label drug use is urgently needed; at the same time, more education and training on off-label drug use should be provided to targeted healthcare professionals.
Highlights
Off-label drug use is widespread in pediatric drug treatment, and the implementation of guidelines on this topic remains challenging
Some of the findings in this survey were consistent with the results of earlier studies carried out in Western countries such as that off-label drug use was widespread and common, that the majority of healthcare professionals were familiar with the concept of off-label drug use, and that a lack of pediatric dosage information was one of the main reasons for off-label prescribing, while dosage was highlighted as the most common category of off-label drug use [20, 21]
31% of hospital based pediatricians admitted to obtaining informed consent when they were prescribing an off-label medicine in Scotland [22], with a similar rate reported in a Northern Ireland study (30.7%) [16]; In this study, we found a lower rate of 21.6%, despite 83.5% of the respondents agreeing that parents or guardians should be informed when an off-label medicine was prescribed for their children
Summary
Off-label drug use is widespread in pediatric drug treatment, and the implementation of guidelines on this topic remains challenging. The objective of this study was to evaluate current practice and awareness of healthcare professionals towards pediatric off-label drug use, as well as the barriers to guideline implementation among pediatric healthcare professionals in Shanghai, China. Off-label drug use is defined as “drugs prescribed and used outside their licensed indications with respect to dosage, age, indication, or route” [1]. Off-label prescribing can jeopardize patient safety in certain clinical scenarios where a positive benefit-risk ratio is not fully established. This is mainly due to the fact that off-label drug use is not systematically appraised by regulators, guideline formulators or even healthcare policymakers.
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