Supply of unlicensed medicines for children: parents’ experiences

• Research type

  Research Study

• Full title

  Supply of unlicensed medicines for children: A qualitative study exploring the experiences of parents and carers

• IRAS ID

  150577

• Contact name

  Steve Tomlin

• Contact email

  stephen.tomlin@gstt.nhs.uk

• Sponsor organisation

  Guy's & St Thomas' NHS Foundation Trust

• Research summary

  Unlicensed medicines are frequently prescribed within paediatric care. The necessity for this practice results from:
  • a lack of age-appropriate licensed formulations that are suitable to deliver small doses
  • ethical and financial constraints on conducting clinical trials in small paediatric populations

  The Medicines and Healthcare Products Regulatory Agency (MHRA) states that unlicensed medicines should only be prescribed if considered in the best interest of the patient on the basis of evidence and only when there is no licensed alternative. Unlicensed medicines are usually initiated within secondary/tertiary care, with the responsibility for ongoing prescribing passed to the child’s GP.

  Due to lack of a marketing authorisation (‘product licence’), the safety and monitoring requirements of unlicensed medicines are known to be a concern for GPs and community pharmacists. It has been reported that some GPs and community pharmacists are reluctant or unwilling to participate in the supply of unlicensed medicines to children, compromising children’s access to these medicines.

  Whilst it is evident that there is a need for unlicensed medicines to be used in children, the current system for safe and timely supply of these medicines is inadequate. Before the system for medicines supply can be improved it is vital to understand the how the process occurs currently from the user’s experience. This study therefore aims to explore the experiences of parents and carers relating to the supply of unlicensed medicines for their child.

  Semi-structured telephone interviews will be conducted with parents/carers of children who have been prescribed an unlicensed medicine. Participants will be identified via the child’s prescription at the Evelina London Children’s Hospital Pharmacy. The interviews will discuss the parent/carer’s experiences in obtaining the unlicensed medicine and explore their views on how and where they would prefer to obtain their child’s medicines.

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  14/NW/0243

• Date of REC Opinion

  7 Apr 2014

• REC opinion

  Favourable Opinion