Pediatric off‐label drug use in China: risk factors and management strategies

Zhang, Lingli; Li, Youping; Liu, Yi; Zeng, Linan; Hu, Die; Huang, Liang; Chen, Min; Lv, Juan; Yang, Chunsong

doi:10.1111/jebm.12017

Cited by 26 publications

(22 citation statements)

References 5 publications

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“…[4][5][6][7] Many studies have shown that neonates have higher risk of using off-label drugs than the children of other age groups. 6,[8][9][10][11] A range from 55 to 80% in the use of unlicensed or off-label drugs at neonatal settings is referred in literature reviews on this theme; the proportion of patients receiving at least one of these drugs ranges from 80-97%. 5,6,11 Other specificities of neonatology are the added risk of preterm newborns to die or develop serious morbidity throughout life.…”

Section: Introductionmentioning

confidence: 99%

Off-Label and Unlicensed Drug Use in Neonatology: Reality in a Portuguese University Hospital

et al. 2015

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Results:We analyzed 1011 prescriptions of 84 active substances, made in 218 admissions. In 42.9% of the cases, medicines were used according to Summary of Product Characteristics information; 27.9% of drugs were approved for neonatal period but used in an off-label manner; off-label drugs for neonates were used in 10.1%, whereas those with undetermined approval state and contraindicated were used 6.0% and 8.7% of the cases, respectively. Unlicensed prescriptions accounted for 4.4% of total. Preterm received a higher rate of drugs used according to Summary of Product Characteristics (p < 0.0001), whereas full-term received more off-label drugs for dose/frequency (p < 0.0001) and contra-indicated for neonates (p < 0.012). Discussion: Preterm neonates received a higher median number of drugs, since they stayed longer in the unit. The main reason for off-label prescribing was the use of doses/frequencies of administration different from those stated in the Summary of Product Characteristics, suggesting that updating these documents is necessary. Manipulation of medicines is one of the causes for unlicensed drugs use, emphasizing the lack of appropriate formulations for neonatal age. Conclusion:Progresses have been made to reduce the risks of off-label/unlicensed prescriptions, but competent authorities must continue their efforts to develop safer and more effective drugs for neonatal period.

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Section: Introductionmentioning

confidence: 99%

Off-Label and Unlicensed Drug Use in Neonatology: Reality in a Portuguese University Hospital

et al. 2015

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“…To improve the efficacy and safety of drugs used in the paediatric population, there is a need to increase research on new drugs and medications that are already on the market but have not been adequately adjusted for children. 22 Although several countries have encouraged protection against OLDU by authorizing a large number of new products with paediatric indications and ageappropriate pharmaceutical forms, 22 there is still an urgent need for regulations of OLDU not only for medical institutions but also for physicians, 23 as they are regularly confronted with questions of efficacy and safety, and ethical issues. 22 Patients will believe that all prescribed medicines have been approved by the country's regulatory agencies.…”

Section: Resultsmentioning

confidence: 99%

Off-label paediatric drug use in an Indonesian community setting

et al. 2015

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“…46 Neonates are the highest-risk paediatric population for off-label medicine use. 47 They require special consideration due to variables including prematurity and low birth weight affecting pharmacokinetics and pharmacodynamics. 10 An associated risk is the lack of child-appropriate dosage forms for medicine administration.…”

Section: Paediatricsmentioning

confidence: 99%

Navigating off‐label and unlicensed medicines use in obstetric and paediatric clinical practice

Gray

McGuire

2019

Pharmacy Practice and Res

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Off‐label or unlicensed medicines use is extremely common in obstetric and paediatric clinical practice and necessitates greater emphasis on the underlying evidence of a medicines safety or efficacy. This creates significant challenges for pharmacists relating to the supply and use of medicines in this setting. Understanding how and why unlicensed or off‐label medicine use occurs, together with the underlying evidence base, is critical for supporting the quality use of medicines. Addressing issues surrounding unlicensed or off‐label medicine use in a collaborative manner with prescribers and patients can help reduce unnecessary patient concern, possible non‐adherence and risk of suboptimal treatment outcomes. This review summarises current evidence and challenges surrounding off‐label and unlicensed medicine use in the obstetric and paediatric clinical setting from the perspective of key stakeholders. It aims to support pharmacists in their evaluation of the appropriateness of off‐label and unlicensed medicine use, and provide strategies to help manage these challenging medicines management decisions.

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Pediatric off‐label drug use in China: risk factors and management strategies

Cited by 26 publications

References 5 publications

Off-Label and Unlicensed Drug Use in Neonatology: Reality in a Portuguese University Hospital

Off-Label and Unlicensed Drug Use in Neonatology: Reality in a Portuguese University Hospital

Off-label paediatric drug use in an Indonesian community setting

Navigating off‐label and unlicensed medicines use in obstetric and paediatric clinical practice

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