Medicines Safety: Paediatric formulations provided by hospital pharmacies

Dr Andy Lowey Lead Clinician - Clinical Pharmacy & Preparative Services, Leeds Teaching Hospitals NHS Trust, UK

Medicines legislation was introduced in many countries around 50 years ago, largely as a response to the risks associated with medicines use in vulnerable patients, including unborn children and neonates.

In 2018, the quality, safety and efficacy of medicines used in paediatric patients remains problematic despite various strategic attempts to address the problem and to encourage more research into paediatric medicines use.

This session will explore the background to the current situation and examine some of the potential risks and why they still persist today. Andy will discuss some of the options open to prescribers and pharmacists, and discuss the relative level of risk associated with different types of paediatric medicines.

Topics for discussion will include cost, formulation quality and excipient choice, fitness-for-purpose, access to robust supply chains, and the level of patient/carer information available.

Building on the success of standardised chemotherapy doses (also known as “dose-banding”), the UK is now attempting to mitigate some of the risks involved by moving towards a more standardised approach to the use of certain “high risk” medicines. This includes a focus on the large range of oral liquid medicines which are commonly used in children.

Andy will share the approach to standardisation and risk mitigation, using examples that will include the treatment of tuberculosis in children in the UK; this represents a good example of a high risk area therapeutic area, and the use of high risk medicines with a narrow therapeutic index in a vulnerable patient population.

Are we doing enough to provide high quality, safe and effective medicines for our children?

Andy is a senior pharmacist and independent prescriber at one of the UK’s largest teaching hospitals, with responsibility for pharmacy services provided to the Leeds Children’s Hospital, the Leeds Cancer Centre and the Intestinal Failure Service. He also leads the preparative service, which operates 7 days a week and produces in excess of 200,000 ready-to-use parenteral items each year.

He advises the Royal Pharmaceutical Society of Great Britain on the quality assessment and risk assessment of the unlicensed use of medicines and is the co-editor of the Handbook of Extemporaneous Preparation. Andy is also a member of the UK Paediatric Chief Pharmacists’ Group.

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