| Role of pharmacoepidemiology in evaluating prescription drug safety in pediatrics. | |
| | |
MedLine Citation:
|
PMID: 17854515 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
BACKGROUND: Pharmacoepidemiology is a discipline that applies epidemiological methodologies to the study of drug use, especially the safety of drug use in a large group of people. But this methodology has not been widely utilized to assess drug safety in pediatrics for children aged between 0 and 18 years. OBJECTIVES: (1) To describe current gaps in evaluating pediatric drug safety; (2) to use published examples demonstrating the value of pharmacoepidemiology in detecting and quantifying adverse drug events in pediatrics; (3) to review pharmacoepidemiological study designs, their strengths and limitations, and examples of their applications in the field of drug safety evaluation; and (4) to provide recommendations about selecting an appropriate study design and minimizing a major methodological limitation. OVERVIEW: Only about 20% of approved drugs are licensed for pediatric use, and many prescription drugs are used as 'off label' or 'unlicensed' pediatric treatments. Among this small percentage of licensed pediatric drugs, pre-marketing trials may not adequately address all drug-related safety issues in pediatrics. Consequently, an important gap exists in pediatric drug safety evaluation. Pharmacoepidemiology offers a number of advantages in detecting and quantifying adverse drug events in pediatrics. Each pharmacoepidemiological study design has its own strengths and limitations in the evaluation of drug safety. An appropriate study design depends on the underlying research question being addressed. Confounding by indication, the most serious and challenge form of confounding in pharmacoepidemiological designs, could lead to misleading claims about the relationship between drug use and the development of potential adverse drug events, and should be adequately controlled. CONCLUSIONS: Pharmacoepidemiology is a powerful methodology that offers many advantages to assess pediatric drug safety such as large sample size, long period of follow-up, and good generalizibility. But this methodology should be applied judiciously to maximize its potential. |
| | |
Authors:
|
Xuemei Luo; Jim Doherty; Joseph C Cappelleri; Karen Frush |
Related Documents
:
|
2719355 - Comparative efficiency of a laboratory and examining room assay for therapeutic drug mo... 10272395 - Rational approach to therapeutic drug monitoring. 10223775 - A multiple-dose safety and bioequivalence study of a narrow therapeutic index drug: a c... 18406595 - Encapsulation of lead from hazardous crt glass wastes using biopolymer cross-linked con... 1970585 - Paradoxical bronchospasm associated with the use of inhaled beta agonists. 9098655 - Drug interactions with proton pump inhibitors. |
Publication Detail:
|
Type: Journal Article; Review |
Journal Detail:
|
Title: Current medical research and opinion Volume: 23 ISSN: 1473-4877 ISO Abbreviation: Curr Med Res Opin Publication Date: 2007 Nov |
Date Detail:
|
Created Date: 2007-11-02 Completed Date: 2008-01-16 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 0351014 Medline TA: Curr Med Res Opin Country: England |
Other Details:
|
Languages: eng Pagination: 2607-15 Citation Subset: IM |
Affiliation:
|
Duke University Health System, Durham, NC, USA. xuemei.luo@pfizer.com |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Child Humans Pediatrics* Pharmaceutical Preparations / adverse effects* Pharmacoepidemiology* |
| Chemical | |
Reg. No./Substance:
|
0/Pharmaceutical Preparations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Quantification of cardiac baroreflex function at rest and during autonomic stimulation.
Next Document: Natural cycle IVF: a question of semantics?