alexa Assessment Of Off-label And Unlicensed Drug Prescriptions In Children: Discrepancies Between FDA And ANSM Guidelines | 63961
ISSN: 2161-0665

Pediatrics & Therapeutics
Open Access

Like us on:

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations
700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

10th Annual World Congress on Pediatrics,Pediatric Gastroenterology & Nutrition

Lydia Rabbaa Khabbaz
Saint-Joseph University of Beirut, Lebanon
Posters & Accepted Abstracts: Pediat Therapeut
DOI: 10.4172/2161-0665.C1.037
Abstract
The main objectives of this study were to assess the incidence of off-label (OL) and/or unlicensed (UL) prescriptions in a sample of Lebanese pediatric patients using FDA and ANSM regulations, to analyze the divergences between both regulations and to identify drugs most commonly involved in OL-UL utilization. This study was a retrospective analysis (500 pediatric files) conducted in a Lebanese university hospital in 3 pediatric wards: Chronic diseases, acute diseases, and pediatric intensive care unit. Each medicine was assessed twice, using FDA and ANSM regulations, to determine if it was an OL or UL prescription. The frequency of OL-UL drug was significantly different between pediatric wards (P<0.001) with the highest incidence occurring in the intensive care unit. It was also significantly related to the presenting complaint (P<0.001) with the most frequent OL-UL prescriptions occurring for cancer (oncology) admissions. Age was significantly related to OL-UL frequency (highest incidence in children between 0 and 1 year). The number of drugs prescribed per patient ranged between 1 and 20 (average 4.13±2.6). The incidence of OL-UL prescriptions was significantly higher in patients treated with a greater number of medicines (P<0.001). 58.9% of drugs prescriptions were authorized according to ANSM and 50.7% according to FDA regulations; 11.1 % (ANSM) and 15.8% (FDA) were unlicensed; these percentages were 30.2 and 33.5 respectively for OL use (where OL for the indication were the most common). The highest % of OL-UL prescriptions was seen with the following groups: blood and blood forming organs, genitourinary system and sex hormones, and alimentary tract and metabolism. Divergence between FDA and ANSM was mainly observed for OL medicines. UL prescriptions assessed according to both regulations showed similar results. For 40.8% to 41.7% of UL prescriptions, an authorized alternative was available. This study highlights the need for prescribers to continuously examine official regulations’ updates in order to avoid using an OL-UL drug whenever it is evitable and calls for a better harmonization between worldwide official guidelines concerning drugs used in children to reduce risk factors for adverse drug reactions.
Biography

Email: [email protected]

image PDF   |   image HTML
 
Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2018-19
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri & Aquaculture Journals

Dr. Krish

[email protected]

1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

General Science

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001Extn: 9042

 
© 2008- 2018 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
Leave Your Message 24x7