ABSTRACT
Title
Pharmacovigilance in paediatrics quality care: the role of family paediatrician
Authors
M.R. Filograna
(Responsabile nazionale qualità FIMP, Lecce)
(Responsabile nazionale qualità FIMP, Lecce)
Abstract
In quality primary care, one of the benchmarks together with appropriateness, efficacy, efficiency and customer satisfaction, is safety care, especially in paediatric age, because children are the most widely exposed subjects to toxic and adverse drug reactions (ADRs). (1)
Surely pharmacovigilanceis the most suited and qualified instrument to check possible events and adverse reactions during assumptions of drugs in children attended.
Family paediatrician and his capillary diffusion on the territory, as trustworthy parents reference and for his specific knowledge, are able to check collateral effects and adverse drugs reactions (ADRs) trough a prompt report, but it can be even faster if organized in network throughout the country.
Our aim is to stimulate a continuous quality improvement process in paediatrics care trough both continuous education in pharmacovigilance and shared reporting procedures. (2)
In fact a pregnant data-gathering in this field will let to find standards or safety indicators in drugs commonly used in paediatric age, considering that most of them are “off –label”.
To improve the quality care in pharmacology it is evident that our aim will be to reduce clinical error according to drug monitoring and drug management , but it is necessary to evaluate the ratio risk/benefit of pharmacological treatment in paediatric age based on process and outcome indicators in the evaluation of quality health care. (3-4)
Surely pharmacovigilanceis the most suited and qualified instrument to check possible events and adverse reactions during assumptions of drugs in children attended.
Family paediatrician and his capillary diffusion on the territory, as trustworthy parents reference and for his specific knowledge, are able to check collateral effects and adverse drugs reactions (ADRs) trough a prompt report, but it can be even faster if organized in network throughout the country.
Our aim is to stimulate a continuous quality improvement process in paediatrics care trough both continuous education in pharmacovigilance and shared reporting procedures. (2)
In fact a pregnant data-gathering in this field will let to find standards or safety indicators in drugs commonly used in paediatric age, considering that most of them are “off –label”.
To improve the quality care in pharmacology it is evident that our aim will be to reduce clinical error according to drug monitoring and drug management , but it is necessary to evaluate the ratio risk/benefit of pharmacological treatment in paediatric age based on process and outcome indicators in the evaluation of quality health care. (3-4)
- 1. EMEA “GUIDELINE ON CONDUCT OF PHARMACOVIGILANCE FOR MEDICINES USED BY THE PAEDIATRIC POPULATION” January 2007- rev.1
- 2. Santucci S. e Longhi R. “La qualità in Pediatria”, Area Pediatrica 2003, 2, pag. 5-26;
- 3. Langiano Tommaso, art. “Qualità ed assistenza”, Gaslini (rivista di pediatria e di specialità pediatriche), 2002, vol. 34, pag. 24-26;
- 4. Brook R., Cleary PD, “Measuring quality of care”, N.Engl. J. Med. 1996, 335: 966-970;