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Is the provision of paediatric oral liquid unlicensed medicines safe?
  1. Elizabeth Rawlence1,
  2. Andrew Lowey2,
  3. Stephen Tomlin3,
  4. Vivian Auyeung4
  1. 1 Department of Pharmacy, King’s College Hospital NHS Foundation Trust, London, UK
  2. 2 Department of Pharmacy, Leeds Teaching Hospital NHS Trust, Leeds, UK
  3. 3 Department of Pharmacy, Evelina Children’s Hospital, London, UK
  4. 4 Pharmacy Department, King’s College London, School of Medical Education, Institute of Pharmaceutical Science, London, UK
  1. Correspondence to Mrs Elizabeth Rawlence, Department of Pharmacy, Chenye Wing, King’s College Hospital NHS Foundation Trust, London SE5 9RS, UK; elizabeth.rawlence{at}nhs.net and Andrew Lowey; andrew.lowey{at}nhs.net

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Licensed medicines for paediatric patients

In the last two decades, international legislation has been introduced to try to ensure that medicines for use in children are of high quality, ethically researched and authorised appropriately.1 2 This is stimulating improvements in the research and development of suitable paediatric medicines by increasing the number of licensed products (see box 1) with reliable evidence-based dosing and safety profiles.

Box 1

‘Licensed medicine’

A medicine with a marketing authorisation which defines its terms of use. It has also been assessed for efficacy, safety and quality; has been manufactured to appropriate quality standards and when placed on the market is accompanied by appropriate product information and labelling.3

No suitable licensed product available, what’s next?

Although these improvements in legislation have encouraged and promoted the licensing of paediatric medicines, there are still many patients receiving unlicensed medicines due to a lack of available suitable licensed products.

Studies across Europe have shown that at least one-third of children in hospital and up to 90% of neonates in neonatal intensive care receive unlicensed medicines (see boxes 2 and 3).4 Similarly, previous UK studies of paediatric populations within primary care show that unlicensed and/or off-label medicines are used around 11% of the time.5

Box 2

‘Unlicensed medicines’

A medicinal product that does not have a marketing authorisation. The medicine has not been assessed for efficacy, safety and quality to the same standards as a licensed product.

Box 3

Types of unlicensed medicines15

  • ‘Off-Label’: use of a medicine outside the terms of its licence, for example, licensed for intravenous administration but administered orally.

  • ‘Extemporaneous (magistral)’: preparation through manipulation of a medicine into a powder or a suspension for an individual patient by a pharmacist.

  • ‘Special’: medicines made by a pharmaceutical manufacturer under a Manufacturing Specials licence (UK specific).

  • ‘Imported’: medicines with a licence from another country …

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