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Published on 1 May 2007

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Improving safety and formulation in medicines for children

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Peter Mulholland
MSc MRPharmS MCCP
Principal Pharmacist
Pharmacy Informatics
Pharmacy Department
Southern General Hospital
Glasgow
UK
E: peter.mulholland@sgh.scot.nhs.uk

Speaking on the subject of safe medication practice initiatives for children, Professor David Cousins (Head of Safe Medication Practice, National Patient Safety Agency) said that the agency receives around 50-60,000 incident reports each month, of which about 8% are medication related, and rising. Around 7% of these relate to children. 80% of reports are “no harm” and 14% “low harm”. However, “no harm” does not mean “no consequence”.

More than 75% of reports are from acute care, with 60% of reports being related to administration, 16% dispensing and 16% prescribing. Reports are not always complete (eg, only 30% of reports have the drug name field completed). The age section is often not completed, making it difficult to analyse across the age range.

There has been progress towards medicine safety but further analysis of the national reporting and learning system (NRLS) database is required with both better quality and quantity of data required.

Dr Patricia McClean (Consultant Paediatric Hepatologist, St James’ University Hospital, Leeds) presented the keynote lecture on the topic of neonatal liver disease. Most newborn infants develop physiological jaundice within the first two weeks of life and in some this continues for several more weeks. Trying to identify the children with liver disease within this cohort is difficult, as most will appear as healthy as those with physiological jaundice. The recommendation at Leeds was that all babies jaundiced beyond two weeks of age should have a split bilirubin measured (conjugated and unconjugated bilirubin) and those with a raised conjugated fraction should be investigated for underlying liver disease.

The immaturity of the newborn liver means that all neonates also have a degree of physiological cholestasis; thus, the causes of the “neonatal hepatitis syndrome” range from any infection, through metabolic and endocrine disorders, to congenital abnormalities of the biliary tree. It is important to recognise liver disease as early as possible to identify disorders in which early treatment will improve outcome (eg, biliary atresia) and to anticipate the complications of chronic cholestasis, some of which can have devastating consequences (eg, intracranial haemorrhage due to vitamin K malabsorption). More rarely infants present in liver failure with coagulopathy and even encephalopathy. Some have metabolic conditions (eg, tyrosinaemia), which respond to medical therapy, and others may be assessed for liver transplantation but overall there is a high mortality in infants presenting with liver failure.

The prognosis for infants with neonatal liver disease depends on the underlying condition. Many remain cholestatic and require long-term specialised nutritional management with medium-chain triglyceride (MCT)-based feeds and high doses of fat soluble vitamins. Itching due to high concentrations of bile salts in the blood can be a problem. Eventually some children develop cirrhosis and portal hypertension requiring consideration for a liver transplant.

Tony Nunn (Associate Director, Medicines for Children Research Network, University of Liverpool) presented an update on the Medicines for Children Clinical Research Network (MCRN).

Pharmacists working in paediatrics and neo-natology are familiar with the lack of authorised medicines and suitable age-adapted formulations, and with the difficulty in obtaining relevant drug information. Recent Department of Health strategy has emphasised the need for more clinical research and established the UK Clinical Research Network, involving six topic specific networks, including one called Medicines for Children.

The MCRN is coordinated from Liverpool and has six local research networks (LRN), a dedicated paediatric clinical trials unit (CTU) in Liverpool and perinatal CTU in Oxford. The network will facilitate both investigator-led (charity- or grant-funded) and commercial (industry-funded and collaborative) research and should provide a competitive research environment to undertake the clinical trials associated with the new EU regulation on paediatric medicines. MCRN has clinical studies groups (CSG) to establish research priorities and develop studies.

CSG are the drivers of the network and are the primary route by which clinical studies are considered in the development of the MCRN research portfolio. They will identify research priorities within their speciality area and propose and develop trial ideas and proposals. A Pharmacy and Pharmacology group and Methodologies group will provide cross-cutting support to each.

The aim of the MCRN is: “To facilitate the conduct of randomised trials and other well-designed studies of medicines for children, including those for prevention, diagnosis and treatment.”

Recognising the need to improve formulations of medicines for children, the MCRN will appoint three formulation fellows to assist in the investigation of extemporaneous formulations, “adult” dosage forms adapted for children and clinical trial requirements (see Resources).

The development of an electronic-based learning and assessment package for Responding to symptoms of childhood ailments was the winner of the 2006 NPPG/ManMed award. Steve Tomlin (Principal Paediatric Pharmacist, Evalina Children’s Hospital, London) presented the results of the work undertaken using the award funding. Community pharmacists are faced with a challenging situation – to provide high-quality patient care to all customers with limited time. Responding to minor symptoms and referring major illness is a major part of the community pharmacist’s role. The trend of self-care has prompted an increasing number of people to visit their local pharmacies for initial medical advice that is recognised as a valuable resource. However, community pharmacists are under more pressure than ever to manage a growing number of symptoms, not just for adults but also for children, and to provide appropriate advice and treatments. This free online self-learning package is designed with the special needs of children and their carers in mind, by supporting community pharmacists in acquiring knowledge of childhood ailments, their treatments and when it is appropriate to refer. The package is designed to make the process of learning fun, easy and meaningful (see Resources).

Improving the quality and formulation of extemporaneous medicines in the NHS is a 12-month research project supported by a £50,000 grant from the National Implementation Board for the Modernisation of Manufacturing, reported Andy Lowey (Quality Control Pharmacist, St James’ University Hospital, Leeds). Commissioned by the National Quality Control Committee (Working Party for Extemporaneous Dispensing), the aim of the project is to investigate and improve the evidence base behind the most common extemporaneously-dispensed oral liquid medicines.

Following a data collection phase, the most commonly supplied 50 oral liquid medicines were ranked in order of their perceived risk (clinical and technical). This list then provided the basis for prioritisation of further work. A summary of all the available data and information is under construction for each of these 50 drugs. Recommendations will be made for sourcing and pharmacovigilance strategies, and five new monographs will appear in the 2008 British Pharmacopoeia:

  • Phenobarbital (alcohol-free) solution.
  • Mercaptopurine suspension.
  • Methotrexate suspension.
  • Sodium chloride oral solution.
  • Sodium bicarbonate oral solution.

A further 12 products are being investigated.

Mr Lowey stated that, when producing care plans, pharmacists should highlight extemporaneous products as high-risk items and monitor patients carefully. Pharmacists are the only members of the clinical team to possess formulation knowledge.

The Special Products award for best oral presentation was won by Niall Corry (Antrim Hospitals) for his work on reducing the risk of hospital-acquired hyponatraemia developing in children receiving fluid therapy.

An algorithm guideline for parenteral fluid therapy for the initial management of previously healthy children (from one month to 16 years of age) was produced. The types and amounts of fluids required for bolus, maintenance and deficit, along with the monitoring required, have been incorporated into the algorithm. In order to complement the algorithm a new fluid prescription sheet was also drafted. In April 2006 the Acting Chief Medical Officer for Northern Ireland wrote to the chief executives of all acute trusts in Northern Ireland, requesting implementation of the new guideline. The algorithm provides a structure for assessment, decision-making and monitoring. However, it is not a replacement for individual patient assessment and treatment or for consultation with a senior colleague The limited availability of licensed isotonic solutions with a range of glucose and potassium concentrations constitutes a significant obstacle to further reducing the associated risks of IV therapy and this problem also requires to be addressed.

The Special Products award for best poster presentation was won by Vicky Holden and colleagues (Leeds Teaching Hospitals) for their work on Moving the care of children and young adults with acute lymphoblastic leukaemia closer to home: the development of a model for home-based maintenance therapy.

The aim of the project was to develop and establish a system of home-based maintenance therapy for children and adolescents treated for acute lymphoblastic leukaemia at the Yorkshire Regional Centre for Paediatric and Adolescent Oncology. Patients on maintenance therapy previously attended the outpatient clinic in Leeds on a weekly or fortnightly basis, resulting in disruption to family life and schooling.

The project has now been implemented for over a year, and 63 patients have been recruited on to the scheme. Patient/parent questionnaires show that families are satisfied with the scheme. It has helped patients to attend school more frequently while causing less disruption to family life. The outpatient clinic has benefited, as clinic lists are now shorter, resulting in shorter waiting times. The compliance audit, assessed by tablet counting, has revealed compliance issues in some families. Reviewing patient/parent education and counselling on maintenance therapy have addressed this problem. Poor compliance has led to the removal of two patients from the scheme. It is planned to introduce pharmacist supplementary prescribing for maintenance therapy dose modifications between clinic visits.

Resources
Medicines for Children Research Network
W: www.mcrn.org.uk
Paediatric Minor Ailments Electronic Learning Package
W: www.paedpharm.org.uk
Neonatal and Paediatric Pharmacists Group www.nppg.org.uk



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