Article Text

Download PDFPDF
Improving safety of unlicenced liquid specials medicines in the UK
  1. Yincent Tse1,2,
  2. Jan Dudley3,
  3. Ashifa Trivedi4,
  4. Jo Crook5,
  5. Daniel B Hawcutt6,7,
  6. Stephen Tomlin8
  7. On behalf of the Joint RCPCH/NPPG Medicines committee
  1. 1Great North Children's Hospital, Newcastle Upon Tyne, UK
  2. 2Newcastle University Faculty of Medical Sciences, Newcastle upon Tyne, UK
  3. 3Bristol Royal Hospital for Children, Bristol, UK
  4. 4NHS London Procurement Partnership, London, UK
  5. 5Paediatric Pharmacy, Kings College Hospital, London, UK
  6. 6Department of Women’s and Children’s Health, University of Liverpool, Liverpool, UK
  7. 7NIHR Alder Hey Clinical Research Facility, Liverpool, UK
  8. 8Children’s Medicines Research & Innovation Centre, Great Ormond Street Hospital for Children, London, UK
  1. Correspondence to Dr Yincent Tse; yincenttse{at}nhs.net

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Unlicenced medicines (‘specials’) for children pose a pervasive and important safety concern for the National Health Service (NHS). Specials are usually supplied when no suitable licenced product exists and thus are an essential resource in the appropriate treatment of children. They represent around 1% of all prescriptions in the UK but account for more than 75 000 formulations.1 These medicines may have different strengths, tastes, excipients, bioavailability, storage conditions and stability (shelf life). In hospital settings, many of these problems with specials are mitigated, for example, through experience and risk management with specific products, and limiting the range of options. However, problems increase when liquid specials medicines are initiated in hospital but resupplied in the community.

One of the most common errors occurs due to a change in concentration of the liquid supplied without the parent or carer being aware of the change, potentially leading to severe, even fatal consequences. In the UK, several specials suppliers exist. When community pharmacies receive a prescription for a specials medicine, they may therefore procure it from a different supplier to the one used by the initiating hospital, leading to variations in strength, appearance, taste and ingredients (with limited or no data on bioequivalence). This lack of consistency across pharmacies can pose challenges for patients and their families.

Harm caused to children through inadvertent underdosing and overdosing of liquid medicines is not a new issue, and paediatric medication errors affect 10–20% of prescriptions and administrations.2 Even 10-fold dosing errors are not uncommon and can lead to significant harms.3 4 It is important to be aware of the risks associated with providing medicines to children, and the importance of stringent prescribing, ordering, dispensing, checking and counselling processes.

The continued use of a wide range of specials have led to a succession of serious …

View Full Text

Footnotes

  • X @YincentTse, @AshifaTrivedi, @joeyjocrook, @Pharmaforkids

  • Collaborators On behalf of the Joint RCPCH/NPPG Medicines committee.

  • Contributors The idea for the article and content was generated at the Joint RCPCH/NPPG Medicines committee by all members which included all authors. ST initially collated the recommendations. All (YT, JD, AT, JC, DBH, ST) contributed to the text of the article, edited and approved final version. YT prepared the initial draft and is the guarantor.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests All authors are members of the Joint RCPCH/NPPG Medicines committee. No other conflict of interests have been identified.

  • Provenance and peer review Not commissioned; externally peer reviewed.