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Delivering Better Medicines to Children

Need for Better Integration Between the Science, the Policy, and the Practice

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Abstract

We are experiencing an exciting and unprecedented period in the history of children’s medicines globally. Milestone developments unfolding in recent years include the formation of the International Alliance for Better Medicines for Children in 2006 and landmark initiatives by the EU, the World Health Assembly (WHA), and the WHO in 2007. However, the challenges of optimizing the development, wider availability, and routine use of effective, safe, and affordable medicines addressing important child health needs are considerable. Each aspect of this continuum has so far received differential attention. Major initiatives in the US and EU have focused on stimulating research into children’s medicines, largely driven by drug regulatory reforms, but with important gaps remaining. Many countries are lacking similar reforms, so the benefits of these initiatives are currently not well reflected in the rest of the world. A systematic approach to knowledge translation to improve use of best evidence and deliver quality use of medicines (QUM) to children routinely has also been largely a ‘missing link’ so far. The WHO’s Essential Medicines List for Children and related initiatives are addressing improving children’s access to needed medicines. Priority research gaps, especially in the developing world, are also being pursued by the WHO. However, in many countries, including developed nations such as Australia, the policy response to the WHA resolution on ‘Better Medicines for Children’ has been inconsistent or fragmented. A better integrated overall approach, linking global medicines research efforts to child health needs and actual medicines use is needed. International networking to support the conduct, synthesis, and rapid dissemination of pediatric medicines research will help close knowledge gaps at a global level. Harmonization of pediatric drug regulation will support this goal and facilitate improving access to needed medicines. Increasing research into and dissemination of effective strategies to promote QUM is an essential component to maximize return (in health benefits) on increased investment in medicines research. A greater focus on QUM should also help create demand for better evidence from clinicians. Delivering on the promise of better medicines for children, wherever in the world they may be, depends on achieving successful integration between the science, the policy, and the practice of pediatric medicines.

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References

  1. Ward RM, Kauffman R. Future of pediatric therapeutics: reauthorization of BPCA and PREA. Clin Pharmacol Ther 2007; 81(4): 477–9

    Article  PubMed  CAS  Google Scholar 

  2. MacLeod S, Peterson R, Wang Y, et al. Challenges in international pediatric pharmacology: a milestone meeting in Shanghai. Pediatr Drugs 2007; 9(4): 215–8

    Article  Google Scholar 

  3. Stephenson T. “bonne anne”, “gutes neues jahr”? Will 2007 be a “happy new year” for children’s medicines in Europe? Arch Dis Child 2007; 92: 661–3

    Article  PubMed  CAS  Google Scholar 

  4. Permanand G, Mossialos E, McKee M. The EU’s new paediatric medicines legislation: serving children’s needs? Arch Dis Child 2007; 92: 808–11

    Article  PubMed  Google Scholar 

  5. Hoppu K. Paediatric clinical pharmacology: at the beginning of a new era. Eur J Clin Pharmacol 2008; 64(2): 201–5

    Article  PubMed  Google Scholar 

  6. WHO. Make medicines child size (2007) [online]. Available from URL: http://www.who.int/childmedicines/en/ [Accessed 2008 Dec 9]

  7. Schreiner M. Paediatric clinical trials: redressing the imbalance. Nat Rev Drug Discov 2003; 2: 949–61

    Article  PubMed  CAS  Google Scholar 

  8. Li JS, Eisenstein EL, Grabowski HG, et al. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA 2007; 297(5): 480–8

    Article  PubMed  CAS  Google Scholar 

  9. Roberts R, Rodriguez W, Murphy D, et al. Pediatric drug labelling: improving the safety and efficacy of pediatric therapies. JAMA 2003; 290(7): 905–11

    Article  PubMed  Google Scholar 

  10. Grieve J, Tordoff J, Reith D, et al. Effect of the pediatric exclusivity provision on children’s access to medicines. Br J Clin Pharmacol 2005; 59(6): 730–5

    Article  PubMed  Google Scholar 

  11. Lenfant C. Clinical research to clinical practice: lost in translation? N Engl J Med 2003; 349: 868–74

    Article  PubMed  Google Scholar 

  12. Gazarian M. EBM in practice: paediatrics. Med J Aust 2001; 174: 586–7

    PubMed  CAS  Google Scholar 

  13. Gazarian M. Delivering better medicines to children: need for a better integrated approach. International Paediatric Pharmacology Symposium, 15th World Congress of Pharmacology, International Challenges in Paediatric Pharmacology; 2006 Jun 29–30; Shanghai

  14. Gazarian M. QUM and children: on the cusp of a brand new era [abstract no. 203]. National Medicines Symposium 2008. QUM-what does it really mean for you? The science the policy and the practice; 2008 May 14–16; Canberra (ACT): 75

  15. Hogerzeil HV. The concept of essential medicines: lessons for rich countries. BMJ 2004; 329: 1169–72

    Article  PubMed  Google Scholar 

  16. Australian Government Department of Health and Ageing. The national medicines policy document [online]. Available from URL: http://www.health.gov.au/internet/main/publishing.nsf/Content/nmp-objectives-policy.htm [Accessed 2008 Dec 8]

  17. Australian Government Department of Health and Ageing. The national strategy for quality use of medicines (executive summary) [online]. Available from URL: http://www.health.gov.au/internet/main/publishing.nsf/Content/4CCAC8550BA36A52CA256F1800468A6E/$File/execsumbro.pdf [Accessed 2008 Dec 8]

  18. National Prescribing Service Limited [online]. Available from URL: http://www.nps.org.au/about_us [Accessed 2008 Dec 8]

  19. National Prescribing Service Limited. Annual report 2006–7 [online]. Available from URL: http://www.nps.org.au/__data/assets/pdf_file/0005/26861/nps_annual_report_2007.pdf [Accessed 2008 Dec 8]

  20. Gazarian M, Kelly M, McPhee JR, et al. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust 2006; 185: 544–8

    PubMed  Google Scholar 

  21. Gazarian M. Evaluating appropriateness of off-label medicines use: implications for policy, practice and research [abstract]. The IXth World Conference on Clinical Pharmacology and Therapeutics; 2008 Jul 27-Aug 1; Quebec City (QC)

  22. Gazarian M. Off-label use of medicines in the paediatric population: recommendations for assessing appropriateness. Discussion paper for consultation, 7 May 2007. In: WHO. Expert consultation on essential medicines for children, 9–13 July 2007, Geneva [online]. Available from URL: http://archives.who.int/eml/expcom/children/INDEX_children_07-2.htm [Accessed 2008 Dec 11]

  23. WHO. WHO Model Lists of Essential Medicines [online]. Available from URL: http://www.who.int/medicines/publications/essentialmedicines/en/index.html [Accessed 2008 Dec 19]

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Acknowledgements

Dr Gazarian is a member of the AHMAC PPWG, representing the Division of Paediatrics and Child Health of the Royal Australasian College of Physicians (RACP). She is also a member of the Therapeutics Expert Advisory Group of the RACP; the Paediatric Clinical Pharmacology Sub-Committee of the International Union of Basic and Clinical Pharmacology; and a founding member of the IABMC. The views expressed in this article are those of the author. No official endorsement by any of these organizations is provided or should be inferred. No sources of funding were used to assist in the preparation of this article. The author has no conflicts of interest that are directly relevant to the content of this article.

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Correspondence to Madlen Gazarian.

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Gazarian, M. Delivering Better Medicines to Children. Pediatr-Drugs 11, 41–44 (2009). https://doi.org/10.2165/0148581-200911010-00014

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