Action Research Calls For Children To Have The Right To Properly Tested Medicines
Some children being treated in hospital might not be having their pain adequately controlled due to a lack of clinical evidence on medicines, a researcher suggests today.
James McElnay, Professor of Pharmacy at Queen’s University of Belfast, has just completed a pioneering study into paediatric prescribing – the world’s first research project of its kind and funded by leading medical charity Action Research.
The study was designed to gain a better understanding of medicines which are commonly prescribed to hospitalised children, but which are unlicensed or untested for these young patients. Although Professor McElnay stressed that the doses selected by clinicians in the study were on the whole appropriate and safe, the control of symptoms were questionable, especially regarding the control of pain. He says: ‘This could mean doctors are erring on the side of caution.’ Professor McElnay adds: ‘Whilst any new drug must undergo extensive testing before being used in adults, there is currently no obligation for separate trials for children, which I would argue is a violation of their basic human rights.
‘In this 21st Century, when there is a growing need for clinical excellence, the time has come for doctors to be armed with the confidence of evidence-based guidelines. Children are not merely little adults.’ Children and babies differ from adults in the way that they handle and absorb drugs because their liver and kidneys are less developed, putting them at risk of potential over-dosing. Yet figures estimate that as many as 90% of babies, and 66% of children being treated in hospital are prescribed drugs that are unlicensed or licensed only for use in adults. (BMJ: 321 4 November 2000 pg 1093) Findings revealed today in a MORI poll commissioned by Action Research suggest that there is ignorance about the issues among the general public.
More than six in ten (63%) adults believe that medicines are thoroughly tested for use in children and babies before they are used in this country, with 22 per cent of respondents agreeing strongly that this is the case. The same survey found that a third of adults thought that all babies and children in hospital receive medicines that have been tested or licensed specifically for these young patients (33% in each case). One in three of this group are parents with children. Mrs Susan Baker’s 13-year-old son James was one of 500 young patients that took part in the Action Research study. The Belfast teenager suffers from a range of conditions including an immune deficiency disorder, epilepsy, and muscle weakness, and has daily pain.
Mrs Baker says: ‘When James first became ill I wasn’t aware that medicines are often unlicensed or untested for children, and I was more than willing to help in the research study because I value its importance. ‘James’ care has been second to none but more research and therefore more scientific evidence would give parents like me so much more reassurance and the confidence that medicines are being used appropriately.’ The pioneering three-and-a-half-year-study, to which Action Research has committed almost £214,000 in funding, was spearheaded at Belfast’s Queen’s University and The Royal Hospital for Sick Children, in collaboration with Liverpool’s Alder Hey Children’s Hospital.
It is the first part of an ongoing research programme that has focused on a range of drugs including, for example, those used for post-operative pain, heart conditions and oral sedatives. More than 1,000 blood samples were collected from almost 500 infants and children, as part of their routine clinical management, and the effect of the medicines, beneficial or otherwise, analysed. According to the findings, some of which are being revealed at The British Pharmaceutical Conference in Manchester in September, a considerable percentage (42.1 per cent) of young patients were still suffering moderate pain after being given Diclofenac, a post-operative pain-killer. And in a small percentage of patients (1.3 per cent) the pain was recorded as severe. Professor McElnay observed: ‘This, together with the general lack of anticipated side-effects, begs the question as to whether the dosage of the pain-relieving preparations could have been increased without risk to the patients, and to their benefit. This type of research will need ongoing analysis.’
He says the main success of the study has been to establish the sophisticated methods for performing the research. This new system will pave the way for new collaborations with other children’s hospitals and therefore scientific guidance for additional medicines. Professor McElnay says: ‘There are obviously many ethical difficulties associated with clinical trials in children, but our approach overcomes some of these.
The methodology is applicable to all medicines used in children, and is ripe for expansion,’ he says. ‘The bottom line is that children in hospital and primary care deserve the same rights as adults when it comes to having access to evidence-based medicine.’ Simon Moore, Chief Executive at Action Research agrees: ‘We should never be in the hazardous situation where prescribing drugs for children and babies is based on assumption, or even worse guesswork.
This research is taking groundbreaking steps forward.’ Notes To Editors: For further information and interviews, please contact Nicole Duckworth or Vicki Rayment in the Action Research press office on 01403 327403/404 Fax: 01403 210541, or email firstname.lastname@example.org ISDN facilities are available *MORI Social Research Institute interviewed a representative quota sample of 2,065 adults aged 15 and over. Interviews were conducted face-to-face in homes across Great Britain in 191 constituency-based sampling points. Interviews were carried out between July 25-30 2002.
For further information please contact Michele Corrado or Claire O’Dell at MORI on 0207 347 3000. *The British Pharmaceutical Conference is taking place in Manchester between September 23-25, and is organised by the Royal Pharmaceutical Society of Great Britain