Aim Patient information leaflets (PILs) have been a legal requirement in the UK for all medicines for almost 20 years. However, as many of the drugs used in children with cancer are unlicensed or used outside the terms of their licence ‘off- label’, information provided by the manufacturer does not always tell parents/patients everything they need to know about the use of the medicine in children and young people. In 2014, a survey conducted by the Children’s Cancer and Leukaemia Group (CCLG) revealed 92% of parents wanted more drug specific information. The aim of this piece of work was to address these information needs through the development of standardised drug specific factsheets for children and young people with cancer.
Methods Information was collated on the availability of paediatric drug specific PIL’s at primary treatment centres (PTC’s) in the UK and Ireland. The CLLG and members of the Paediatric Oncology Pharmacists (POP) group worked together in reviewing and comparing a selection of PIL’s already available, in addition to agreeing a standardised format and outline of headings for proposed factsheets. Drafts were produced for 10 of the most common oral chemotherapy drugs used in children. These were reviewed for content, language, punctuation, grammar and structure by a wide range of end users, such as parents of children on treatment, parents of children whose treatment had finished, clinical nurse educators, paediatric oncology/haematology consultants, clinical nurse specialists, ward managers and different members of the POP group. Feedback and comments were collated. Proposed changes suggested were either actioned or reasons for not actioning documented on a change log. This process repeated until a final version was agreed.
Results Of the 12 PTC’s, 5 had their own oral chemotherapy PIL’s, with the range of leaflets available varying across these five centres. Only 1 PTC had their own intravenous (IV) chemotherapy PIL’s. Information provided varied from centre to centre with drug information also provided from treatment protocols, the Macmillan website or from the manufacturers summary of product characteristics (SPC). Factsheets for the following oral chemotherapy drugs have been produced; chlorambucil, cyclophosphamide, dexamethasone, etoposide, imatinib, lomustine, mercaptopurine, methotrexate, procarbazine and temozolomide. A factsheet on the ‘safe handling of oral chemotherapy’ was developed alongside these to further support parents in managing their child’s oral chemotherapy safely at home.
Conclusion User engagement is paramount in producing information that is clear, accurate, up-to-date, easy to understand and practical. Factsheets are available to order/download free of charge providing equal access to all healthcare professionals, parents/carers and patients across the UK and Ireland, ensuring families are not disadvantaged by geographical treatment location. Current multimedia technology offers the benefit of increased and fast access to information; however, a further survey of families is required to establish whether parents drug information needs have been met though the availability of these factsheets.
Standardised IV chemotherapy factsheets and additional oral drug factsheets for dasatanib, hydroxycarbamide and isotretinoin are currently in development. MHRA Medicines and Healthcare Products Regulatory Authority (2012) Best practice guidance on patient information leaflets [Online]. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/328405/Best_practice_guidance_on_patient_information_leaflets.pdf (accessed 12 Jun 2018)
Shinfield, C. Chief Information Officer. Children’s Cancer and Leukaemia Group. Personal communication. 25thNovember 2015
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