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Simon Keady is principal pharmacist, women and children’s services, University College London Hospital NHS Foundation Trust. Ian Costello is senior editor, BNF for children. Steve Tomlin is principal pharmacist, paediatrics, Guy’s and St Thomas’ NHS Foundation Trust |
The role of the paediatric pharmacist in delivering pharmaceutical care to children and young people is increasing in significance. Paediatric pharmacy encompasses all the clinical specialties present in adult medicine and paediatric pharmacists must therefore have a working knowledge of all these areas. They must also have a sound knowledge of the concepts of drug use and medicines management across a whole range of ages — from birth and in neonatal intensive care units, through to adolescence and the transition to adult medicine.
Extra care and attention
Although health professionals may be familiar with the mantra “children are not little adults and cannot be treated as such”, it is often overlooked. Children’s bodies handle medicines differently from those of adults and wide variations occur between different age groups. Therefore, care and attention needs to be paid when making prescribing decisions for children, which must take into account their stage of development. Lack of evidence on the use of medicines in children leads to uncertainty in dosing. Even at the most appropriate dose, the use of medicines in children can lead to differences in effectiveness and adverse effects compared with use in adults.
More than any other patient group, drug treatment in children needs to be adjusted to response. Monitoring and adjustment of therapy requires a detailed knowledge of variations in pharmacokinetics and pharmacodynamics as well as other factors that influence efficacy, such as administration, formulation and absorption. However, there are no special systems in place to help parents manage their children’s medication effectively, which is a particularly important issue in chronic medical conditions such as epilepsy. In many cases, these families may receive less information than others since patient information leaflets (PILs) are often not relevant to paediatric conditions. Pharmacists are in a unique position to provide this expertise in an acute and chronic setting in both primary and secondary care.
Patient information
The national move towards using manufacturers’ patient packs may provide problems for pharmacists working with children. Legally, PILs must be provided even if the medicine is being used in an off-label manner, eg, because of the age of the patient. However, PILs often contain information that is not relevant or may be alarming to patients, and the paediatric pharmacist has a pivotal role in ensuring that the parent or carer’s confidence is maintained.
Adequate information should be made available so that the parent, carer or, where appropriate, the young person can make an informed decision regarding their medicines. Additional information should be given if possible and generic leaflets are available for parents and adolescents explaining the use of unlicensed and off-label medicines. The feasibility of producing nationally available information leaflets for using such medicines in children is under discussion. It is hoped that this process will engage the views of children and parents and that the information will in the future be available in suitable formats for different age groups.
Medicines at school
Schoolage children may have to take medicines during the school day. This can cause problems, especially if the school does not have a robust policy on the storage, handling and administration of medicines. These problems can often be overcome by using the pharmacist’s knowledge in drug selection and dosing to allow for either once- or twice-daily drug administration.
Teachers may need support in managing medicines in schools. Pharmacists have an opportunity to be involved in the development of medicines policies in schools and to provide training for teachers to enable them to support pupils with long-term medical conditions who need to take medicines in school. Development of pupil-focused education initiatives around health and drugs is also a possibility.
Licensing issues
On paediatric wards, at least 25 per cent of medicines prescribed are used outside their product licence.1–3 This is often considered central to many of the issues in paediatric medicines management and is unavoidable because most new drugs that go through the licensing process have only been investigated for adults. This lack of evidence in safety and efficacy raises specific issues for clinical governance and presents a particular challenge to paediatric pharmacists. Children should not be denied effective treatment simply because of the licence status of a drug for a particular age group. Pharmacists are in a unique position to evaluate the evidence, risks and consequences of drug use and inform other health care professionals appropriately.
In September 2004, the European Commission accepted a proposal entitled “Better medicines for children” which was designed to encourage more research to be carried out on medicinal products for use in children.4 It is hoped that this will become European law in late 2006, leading to more licensed products for children.
Problems brought about by the lack of paediatric licensed medicines include crushing tablets to form suspensions, using vials containing 100 times overdose amounts for neonates, suspensions containing enough alcohol to harm an infant seriously and a general lack of evidence for dosing. Formulation and administration can directly affect treatment efficacy. Once again, pharmacists are uniquely qualified to advise and influence treatment, and risk management assessments of all new drugs, formulations and preparations should form part of this role.
Risk assessment should include a review of the appropriateness of the formulation and the potential for error in normal use. Systems to minimise the potential for error should be designed. Information sources, eg, formularies such as Medicines for Children and especially the recently launched BNF for children are important to paediatric pharmacists in providing informed advice for the recommendation and dispensing of medicines which are either unlicensed or being used off-label.
Problems after leaving hospital
The sometimes complex nature of medicines used by children described above can cause problems when children are discharged from hospital and can pose significant risks (eg, medicines may be unlicensed and difficult to source, information regarding appropriate doses may be difficult to obtain from standard sources or special formulations may be required). Parents often report difficulty in obtaining repeat supplies of unlicensed medicines. However, GPs, community pharmacists and other health care professionals are expected to manage a child’s treatment and provide continuing supplies.
Many of these issues arise because of poor discharge planning and communication or lack of appropriate information. The potential role of the pharmacist in improving paediatric medicines management at this point is obvious. Developing a local, standardised approach across all sectors of health care may be one way of addressing the issues. The National Pharmacy Association has recommended the introduction of a medicines management support programme, specifically designed to support families with complex medicines management needs. Developed through joint working across primary, secondary and tertiary care, this approach could help improve patient care and minimise risks for children who need to take such medicines.
Postgraduate education
At the moment, there are no nationally recognised training schemes or mandatory postgraduate qualifications for pharmacists wishing to work in this field. Experience is normally gained on a day-to-day basis with the support of more experienced paediatric pharmacists, by attending conferences and from study days and journal reading. Paediatric pharmacy expertise may be limited locally due to lack of specific education and training. This lack of underpinning support often puts pharmacists off becoming involved in paediatrics since it is viewed as a complex area of practice. A wider, structured networking of paediatric expertise may help with the provision of training and enable sharing of knowledge and experience and the development of a consistent approach to specific paediatric issues.
In 2002, the Faculty of Neonatal and Paediatric Pharmacy was launched in association with the College fo Pharmacy Practice. This faculty provides professional support for pharmacists in the UK interested in or working in the field of paediatrics. Their aim is to provide a career pathway for practitioners, with competence assessed and acknowledged by experts in the field of neonatal and paediatric pharmacy. The faculty is working closely with both NHS Education for Scotland and the Centre for Pharmacy Postgraduate Education to produce distance learning packages to aid the knowledge and skill requirements set by the faculty.
A number of schools of pharmacy offer modules in paediatrics with their postgraduate courses. However, few of these modules, if any, are aimed at or attract pharmacists from primary care.
There are currently no postgraduate courses available for more experienced paediatric pharmacists, although the School of Pharmacy, London, recently piloted an advanced paediatric module that was targeted at such pharmacists. Six pharmacists successfully completed this course in 2005 and it is hoped that this course will continue to be run over the coming years.
Conclusion
Paediatrics is a unique and rewarding area of pharmacy practice. However, there are challenges in overcoming the significant gaps in paediatric pharmaceutical care that exist. It is expected that continued research into this area will result in the gathering of more solid safety and efficacy data and lead to an increase in the manufacture of medicines specifically tailored to children. This will allow pharmacists to practise more confidently in this specialty.
References
1. Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, et al. Survey of unlicensed and off-label drug use in paediatric wards in European countries. BMJ 2000;320:79–82.
2. Turner S, Longworth A, Nunn AJ, Choonara I. Unlicensed and off-label drug use in paediatric wards — prospective study. BMJ 1998;316:343–5.
3. Dick A, Keady S, Brayley S, Mohamed F, Lloyd BW, Thomson MA, et al. Use of unlicensed and off-label medications in paediatric gastroenterology with a review of the commonly used formularies in the UK. Alimentary Pharmacology and Therapeutics 2003;17:571–5.
4. European Commision — DG enterprise and industry. Pharmaceuticals. Available at http://pharmacos.eudra.org/F2/ (accessed 17 January 2006).
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