ISSN 2321–3647
Sat, 18 Nov 2017

Are unlicensed and off labelled drugs being practiced safely in Pediatric population? A Systematic review

Muhammad A Hamid1*, Jabeen Fayyaz2, Sohaib Siddiqui1, Arif Haque1, Christina Yeung1, Dennis Scolnik3

1. Assistant Professor Pediatrics, University of Toronto & Consultant Paediatrician Rouge Valley Health Services,  2867 Ellesmere Road, Toronto

2.Clinical Fellow Paediatric emergency Medicine , The Hospital for Sick Children

3. Associate Professor, Pediatrics, University of Toronto, Staff Physician
 Pediatric Emergency Medicine

 & Clinical Pharmacology and Toxicology, The Hospital for Sick Children


The aim of this systematic review is to analyze after that is the ‘unlicensed ’ and ‘off labelled ’drugs prescribed for children are being used safely in pediatric after population. A systematic search was made in Medline PubMed, CINAHL and Cochrane Library from 1998 to 2014 addressing the use of unlicensed and off labelled drugs in pediatric population. After that process of identification 29 studies fulfilled the criteria to be included . Total number of pediatric patients covered in the review of 29 selected publications is 3589061. Data from 16 countries are included. Unlicensed use of drug in pediatric age group starting from neonates were found to be from 1.26% - 16.8% with a maximum of 90% use of off-label use of drug in the age group of 23-36 weeks. Almost 34-36% off-label use of these drugs and 62.3% for unlicensed or off-label use of the drugs were found in critical care areas. A range of 3.3% to 76% off-label and 1.26-33%  unlicensed or unapproved drugs usage was found in the OPD and Clinical settings. The drug categories found to be used mostly are analgesic drugs 26.9% and antispasmodic drugs (31.5%). Paracetamol had 25-49% off-label use. A considerable off- label and unlicensed use is observed in pediatric population. The increase in number of studies and awareness is also evident through this review. The regulatory agencies apart from stringent rules to control unapproved use of drugs have to ensure pharmacovigilance of existing drugs. Healthcare providers should be prudent in the use of drugs weighing the risk-benefit analysis and practice informing the parents about the off- label use and start after their consent.

Keywords: Healthcare providers, Pediatric, drugs

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