[EQ] Promoting safety of medicines for children

          Promoting safety of medicines for children

World Health Organization (WHO), September 2007

Available online PDF [64p.] at: http://www.who.int/medicines/publications/essentialmedicines/Promotion_safe_med_childrens.pdf

".....The lack of thorough and reliable clinical data on the way medicines affect children requires strengthened safety monitoring and vigilance of medicinal products. This is the fundamental message of Promoting safety of medicines for children.

The publication gives an overview of the problem and offers solutions on how best to address side effects from medicines in children; namely, through improved reporting systems and collaboration between governments, regulatory authorities, research institutions and the pharmaceutical industry..."

"......Monitoring the safety of medicine use in children is of paramount importance since, during the clinical development of medicines, only limited data on this
aspect are generated through clinical trials. Use of medicines outside the specifications described in the licence (e.g. in terms of formulation, indications,
contraindications or age) constitutes off-label and off-licence use and these are a major area of concern.

These guidelines are intended to improve awareness of medicine safety issues among everyone who has an interest in the safety of medicines in children and
to provide guidance on effective systems for monitoring medicine safety in the pediatric populations. The document will be of interest to all health-care
professionals, medicine regulatory authorities, pharmacovigilance centres, academia, the pharmaceutical industry and policy-makers.

Systems for monitoring medicine safety are described in Annex 1 - Pharmacovigilance methods and some examples of recent information on adverse reactions
to marketed medicines are discussed in Annex 2....."

Content:

1 Introduction

2 Current situation
2.1 Problems with medicine treatment in children and adolescents around the world
2.2 Consequences of present status of the use of medicines in children (environmental aspects).
2.3 General risk factors that predispose children to develop an adverse reaction to a medicine (medical aspects)
2.4 Differences between paediatric populations and adults
2.5 The need for additional, independent studies on the development of paediatric medicines
2.6 Current legal and regulatory framework .
2.7 Consequences of the lack of studies of medicines development in children and authorization of paediatric medicines

3 The essential role of safety monitoring in the life-cycle of a medicine.
3.1 Pre-marketing assessment of medicine safety
3.2 Post-marketing monitoring of medicine safety for medicines already on the market including those used “off-label”
3.3 Benefit-to-risk considerations in children

4 Medication errors.
4.1 Increased risk of medication errors in children
4.2 Incidence of medication errors .

5 Primary responsibility of stakeholders

6 Guidance: measures to be taken.
6.1 Improvement of awareness among stakeholders
6.2 Methods, approaches and infrastructure for an effective system for medicine safety monitoring at the national level.
6.3 Implementation of methods and structural changes for effective monitoring of medicine safety at the national level
6.4 Impact measurement and audit

7 Measures to be taken by WHO.
References
Annex I Annex 2

 

 

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