Unlicensed and off-label prescription of drugs to children in primary health care: A systematic review.

OBJECTIVE

To evaluate unlicensed and off-label prescription and use of drugs to children in primary health care.

METHODS

This is a systematic review that was written based on Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). The studies were extracted from the databases: LILACS, PubMed/MEDLINE, and Scopus. Studies in English, Spanish or Portuguese with abstract available regarding the use and prescription of off-label and unlicensed drugs to children aged 0-18 years in primary health care were included. The evaluation of the titles, abstracts and Full-text were performed independently by two reviewers, and the divergences were resolved by a third reviewer.

RESULTS

Six studies were included. The incidence of off-label prescription varied from 29.5% to 51.7% in relation to the total number of drugs prescribed. The prevalence of off-label drugs ranged from 31.7% to 93.5% in relation to the total number of drugs prescribed. It was observed a higher proportion of off-label prescription related to age and dose. For unlicensed drugs, there was a small variation in incidence between 2.4% and 3.9%, relative to the total number of prescriptions, or between 2.4% and 10.0%, relative to the sample size. It was observed a higher proportion of unlicensed prescription related to children under 2 years of age.

CONCLUSIONS

The unlicensed and off-label prescription of drugs is recurring in the pediatric population of primary health care. It is necessary to have better information on these drugs by the regulatory agencies and the pharmaceutical industries for rational use of drugs in children.