The Status Of Paediatric Medicines Initiatives Around The World—what Has Happened And What Has Not?
K. Hoppu, G. Anabwani, F. García-Bournissen, M. Gazarian, G. Kearns, H. Nakamura, R. G. Peterson, S. Sri Ranganathan, S. D. Wildt
Published 2011 · Medicine
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PurposeThis review was conducted to examine the current status of paediatric medicines initiatives across the globe.MethodsThe authors made a non-systematic descriptive review of current world situation.ResultsTwo regions, the United States (US) and the European Union (EU), and the World Health Organization (WHO) have introduced strong paediatric initiatives to improve children’s health through improving access to better paediatric medicines. The experience from the US initiative indicates that it is possible to stimulate development and study of paediatric medicines and provide important new information for improvement of paediatric therapy. The early results from the EU initiative are similarly encouraging. In Canada, Japan, Australia and other developed countries, specific paediatric medicines initiatives have been less extensive and weaker, with modest results. Disappointingly, current evidence suggests that results from clinical trials outside the US often do not benefit children in the country in which the trials were largely conducted. Pharmaceutical companies that have derived a financial benefit commensurate with the cost of doing the paediatric trials in one country do not seem to be making the results of these trials available to all countries if there is no financial incentive to the company. The WHO campaign ‘make medicines child size’ has produced substantive accomplishments in building improved foundations to improve mechanisms that will enhance children’s access to critical medicines in resource-limited settings. However, practically all of this work has been performed using an amalgamation of short-term funding from a variety of sources as opposed to a sustained, programmatic commitment.ConclusionsAlthough much still needs to be done, it’s clear that with concerted efforts and appropriate resources, change is possible but slow. Retaining and fostering public and political interest in paediatric medicines is challenging, but pivotal for success.
This paper references
Safety and transparency of pediatric drug trials.
D. Benjamin (2009)
Report to the European Commission
Realities of paediatric pharmacotherapy in the developing world
K. Hoppu (2011)
A European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
N. Ruperto (2011)
Pan American Conference on Drug Regulatory Harmonization
Organización Panamericana de la Salud. Medicamentos Esenciales Tecnología (1998)
Pediatric drug labeling: improving the safety and efficacy of pediatric therapies.
R. Roberts (2003)
Will children with cancer benefit from the new European Paediatric Medicines Regulation?
Gilles Vassal (2009)
Recent developments and strategies in pediatric pharmacology research in the USA Pediatric trials network
B Vitiello (2008)
Effect of the pediatric exclusivity provision on children's access to medicines.
Joanne Grieve (2005)
Scaling up priority HIV / AIDS interventions in the health sector JUNE 2008
Balancing the upside and downside of antiretroviral therapy in children.
R. Yogev (2005)
Pediatric Research Equity Act. http://www.fda. gov/downloads/Drugs/DevelopmentApprovalProcess/Development Resources/UCM077853
Us Fda (2003)
In resource-limited settings good early outcomes can be achieved in children using adult fixed-dose combination antiretroviral therapy
D. O'Brien (2006)
Regulation (EC) no 1901/2006 of the European parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) no 1768
Home page. www.micyrn.ca. Accessed 10 Clinical Trials Action Group (CTAG)
WORLD HEALTH ASSEMBLY
J. Glaister (1958)
How to… home page
Challenger Tafe (2004)
WHO global campaign: make medicines child size
Globalization of Pediatric Research: Analysis of Clinical Trials Completed for Pediatric Exclusivity
S. Pasquali (2010)
Eur J Clin Pharmacol
The economic returns of pediatric clinical trials of antihypertensive drugs.
C. Baker-Smith (2008)
Network for drug regulatory harmonization website. http://new.paho.org/hq/index. php?option=com_content&task=blogcategory&id=1156& Itemid=513
Resolution WHA60.20 'Better medicines for children
Guide to Paediatric drug development and clinical research
Klaus Rose (2010)
Paediatric clinical pharmacology—at the beginning of a new era
K. Hoppu (2007)
Pan American Health Organization (no year) Guia para realizacion de ensayos clinicos en poblacion pediatrica—borrador en discusion
Understanding the relative roles of pharmacogenetics and ontogeny in pediatric drug development and regulatory science.
J. S. Leeder (2010)
Pediatric clinical pharmacology
Hannsjörg W. Seyberth (2011)
European Medicines (2011)
Recent developments and strategies in pediatric pharmacology research in the USA
B. Vitiello (2008)
Setting standards for essential children's medicines.
S. Hill (2007)
Delivering Better Medicines to Children
Madlen Gazarian (2009)
The European Regulation on medicines for paediatric use.
J. Dunne (2007)
Three years of paediatric regulation in the European Union
Thorsten M. Olski (2011)
Editorial Comment: Therapeutic Orphans
H. Shirkey (1968)
PANDRH good clinical practices workgroup—draft under discussion—guide for conducting clinical studies in pediatric populations
Pandrh Gpc (2008)
Facilitation of Paediatric Research in Japan
Hidefumi Nakamura (2010)
Stimulation programs for pediatric drug
I Boots (2007)
Global aspects of drug development.
K. Hoppu (2011)
H. Shirkey (1968)
Delivering better medicines to children: need for better integration between the science, the policy, and the practice.
Madlen Gazarian (2009)
European Medicines Agency receives 1,000th application for a Paediatric Investigation Plan or Waiver
Clinical trials in children: an assessment of the information in the Clinical Trials Registry of India (CTRI)
S Manikandan (2011)
Drug therapy in pediatrics: a developing field
L. Mathis (2009)
The selection and use of essential medicines.
P. Kazembe (2009)
Research on neglected priority needs. http://apps. who.int/tdr/svc/research
Stimulation programs for pediatric drug research – do children really benefit?
I. Boots (2006)
Survey of the current state of pediatric drug use in Japan (1994-6). Drug Therapy Committee of the Japan Pediatric Society.
Antiretroviral therapy in children: Indian experience.
S. Natu (2007)
Excellence in Family Paediatricians: the FIMP-MCRN (Medicines for Children Research Network) becomes a member of ENPR-EMA (European Network of Paediatric Research at the European Medicines Agency)
E. Napoleone (2011)
This paper is referenced by
Persistent pharmacokinetic challenges to pediatric drug development
Daniel P. Sage (2014)
J. N. van den Anker (2013)
Adjusting the dose in paediatric care: dispersing four different aspirin tablets and taking a proportion
Jørgen Brustugun (2019)
Pharmacokinetics in neonatal prescribing: evidence base, paradigms and the future
K. O'hara (2015)
Clinical Studies in Infants (Pediatric Pharmacology)
Karel Allegaert (2017)
Comparison of access to medicines between Klang Valley and East Coast of peninsular Malaysia for children living in poor households
Asmalita Saiful (2016)
The Unmet Needs of Paediatric Therapeutics in Poor Countries.
Q. Bassat (2015)
Perfil dos ensaios clínicos envolvendo crianças brasileiras
Jean Mendes de Lucena Vieira (2017)
Methods in pharmacoepidemiology: a review of statistical analyses and data reporting in pediatric drug utilization studies
Marco Sequi (2012)
Clinical pharmacological studies in children: From exploratory towards confirmation driven methodology.
K. Allegaert (2012)
Shifting Demographics and Clinical Pharmacy/Pharmacology Priorities
Stuart M. Macleod (2015)
Uso de medicamentos e outros produtos com finalidade terapêutica entre crianças no Brasil
Tatiane da Silva Dal Pizzol (2016)
Off‐label drug use in hospitalized children: a prospective observational study at Gondar University Referral Hospital, Northwestern Ethiopia
Yonas Getaye Tefera (2017)
Children’s Medicines in Tanzania: A National Survey of Administration Practices and Preferences
L. Adams (2013)
Pediatric pharmacokinetics of the antibiotics in the access and watch groups of the 2019 WHO model list of essential medicines for children: a systematic review
Asia N Rashed (2019)
Questions About Research Involving Children
Ian Mitchell (2019)
The Clinical Relevance of Pediatric Formulations
Karel Allegaert (2014)
Public drug policy for children in Canada
A. Denburg (2017)
Drug evaluation studies in neonates: how to overcome the current limitations
Karel Allegaert (2018)
Two decades of off-label prescribing in children: a literature review
Shamala Balan (2018)
Optimiser l'évaluation des médicaments en néonatologie : l'exemple des médicaments anti-infectieux
F. Kaguelidou (2012)
Better Drug Therapy for the Children of Africa: Current Impediments to Success and Potential Strategies for Improvement
S. Macleod (2013)
Essential medicines for children
K. Hoppu (2015)
Availability of pediatric-evaluated formulations in Serbia
Bojana Božič (2017)
Physiologically based pharmacokinetic (PBPK) modeling and simulation in neonatal drug development: how clinicians can contribute
A. Smits (2018)
Paediatric clinical pharmacology in the UK
I. Choonara (2014)
Inflammatory Bowel Disease National Action Plan Literature Review 2018
Leanne Raven (2019)
Time to change the paradigm of children's medicines from liquid formulations to flexible solid oral dosage forms
C. G. Uragoda (2016)
Are antihistamines effective in children? A review of the evidence
Pauline De Bruyne (2016)
Evolution in Pediatric Pharmacology: Microdosing, metabolism, and membrane transporters
Miriam Mooij (2016)
Pharmacovigilance for Children’s Sake
Kristina Star (2014)
Regulatory and logistical issues influencing access to antineoplastic and supportive care medications for children with cancer in developing countries.
J. Wiernikowski (2014)See more