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European Regulation for Children in Europe
- Imran Mushtaq (15 December 2007)
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Drugs for children in Europe: defining off-label priorities
- Jenny Bua, Federico Marchetti (17 December 2007)
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Imran Mushtaq, Associate Specialist-Child and Adolescent Psychiatrist Eaglestone Centre,Specialist CAMHS Standing Way Milton Keynes MK6 5AZ
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Children all over the world are regularly treated with unlicensed and off label drugs, which is putting them at risk. New European legislation encourages the drug industry to produce high quality transparent research, as hoped by Imti Choonara in her editorial (1).The European Medicines Agency is although, providing considerable financial incentives but will it influence pharmaceutical industry to spend more on paediatric research is anybody guess. American experience is in the favour of extensive investment in adult sector with big profit margins (2). A news item featured in current BMJ, is worrying for clinicians looking after children, with the US Food and Drug Administration (FDA) proposal for drug companies may enable them to send relevant information to doctors regarding ‘’off label’’ and unapproved drug uses (3). This may promote use of unlicensed drugs with false sense of security. It reminds me a small survey of unlicensed drugs in children, many years ago, when I was working in Paediatrics. A small sample involving 10 Paediatric SHO were asked about three drugs not licensed for children and 7/10 (70%) were not even aware of their unlicensed status and were using it without any ‘fear’. Thanks to Children’s BNF, an excellent contribution to children cause by Royal College of Paediatrics and Child Health, this relieves some of junior doctor’s anxieties. REFRENCES: 1. Choonara I. Regulation of drugs for children in Europe. BMJ 2007;335:1221-1222 2. Boots I, Sukhai RN, Klein RH, Holl RA, Wit JM, Cohen AF, et al. Stimulation programs for pediatric drug research—do children really benefit? Eur J Pediatr 2007;166:849-55. 3. FDA may allow drug and device companies to promote "off-label" uses.BMJ 2007;335:1229. Competing interests: None declared |
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Jenny Bua, resident in paediatrics Department of Paediatrics, Institute of Child Health, IRCCS Burlo Garofolo, Trieste, Federico Marchetti
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Sir, in his excellent editorial, Choonara (1) underlines the still very common phenomenon of off-label prescriptions in paediatrics. Although adverse drug reactions are more likely with off-label rather than with licensed products, often the use of off-label drugs represents the most rational, evidence based therapy, and a failure to use them when appropriate may constitute malpractice (2). Choonara (1) highlights the importance of both the European legislation and advocates for an increase in paediatric clinical pharmacologists. Both these initiatives are fundamental ingredients in the recipe to try to “close the gap in drug therapy” between children and adults (3) but not if alone. We do believe that a pivotal step is the identification of specific off-label clinical priorities. We conducted an observational study using a validated questionnaire sent to 32 departments of four tertiary Paediatrics Italian Hospitals, in order to examine the paediatricians’ perception and awareness on off-label usage in their daily practice (4). Among the off-label drugs perceived as a priority by Italian paediatricians there were some for which evidence of their benefit and safety in children already exists (i.e. propofol when performing invasive procedures on children, ciprofloxacin in cystic fibrosis patients younger than 5 years). In this case, a review and update of the Summary Product Characteristics would be sufficient. Other drugs, such as ACE-inhibitors, calcium-antagonists, beta-blockers, midazolam were identified because of the lack of an adequate formulation for paediatric use, which needs urgent measures given the number and severity of clinical conditions which require their use (severe hypertension, cardiac failure, chronic nephropathies, seizures). In the case of other products identified (micophenolate mofetile, rituximab, chetorolac) evidence is still too limited and further studies to test their safety in children are required. We believe that the answer of the off-label problem cannot be left only to incentives to the industry, while it is fundamental, starting from the everyday clinical experience, to better define the off-label priorities to guide the choices of governmental organisations, the pharmaceutical industry, and any relevant bodies or individuals’ in closing the gap between children and adults. References 1. Choonara I. Regulation of drugs for children in Europe. BMJ 2007;335:1221-122 2. Hill P. Off licence and off label prescribing in children: litigation fears for physicians. Arch Dis Child 2005;90 Suppl 1:i17-8. 3. Bonati M, Choonara I, Hoppu K, Pons G, Seyberth H. Closing the gap in drug therapy. Lancet 1999;353(9164):1625. 4. Marchetti F, Bua J, Ventura A, Notarangelo LD, Di Maio S, Migliore G, Bonati M. The awareness among paediatricians of off-label prescribing in children: a survey of Italian hospitals. Eur J Clin Pharmacol 2007;63(1):81-5 Jenny Bua, Federico Marchetti
Corresponding author:
Jenny Bua, MD MSc
Competing interests: None declared |
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