Cargando…

Frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in a southern municipality of Brazil

OBJECTIVE: To determine the frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in medium-sized municipality of Rio Grande do Sul, Brazil. METHODS: Cross-sectional study with retrospective data collection, which analyzed prescriptions issued...

Descripción completa

Detalles Bibliográficos
Autores principales: Gonçalves, Marcele Giacomin, Heineck, Isabela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Sociedade de Pediatria de São Paulo 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4795716/
https://www.ncbi.nlm.nih.gov/pubmed/26530249
http://dx.doi.org/10.1016/j.rppede.2015.06.023
_version_ 1782421650576244736
author Gonçalves, Marcele Giacomin
Heineck, Isabela
author_facet Gonçalves, Marcele Giacomin
Heineck, Isabela
author_sort Gonçalves, Marcele Giacomin
collection PubMed
description OBJECTIVE: To determine the frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in medium-sized municipality of Rio Grande do Sul, Brazil. METHODS: Cross-sectional study with retrospective data collection, which analyzed prescriptions issued to 326 patients from August to December/2012 in two basic health units in the city of Viamão, state of Rio Grande do Sul. It included all prescriptions of patients whose medical records or service records were available and complete in relation to the date of presence, weight and date of birth. Off-label prescriptions were those which, in relation to the drug leaflet, showed dose different the recommended range, frequency of prescription and/or different form of administration and younger age than the indicated range. Descriptive statistics with absolute frequencies, means and standard deviations were used. RESULTS: During the study period, a total of 731 drug prescriptions were issued and the frequency of off-label medications prescribed was 31.7%, especially antihistamines and antiasthmatics (32.3% and 31.5%, respectively). The main type of off-label prescription was dose (38.8%), followed by age range (31.5%) and frequency of administration (29.3%). Regarding the dose off-label prescription, overdose was more frequent (93.3%) than the underdose (6.7%). Prescriptions of unapproved drugs were not identified. CONCLUSIONS: The study showed that off label prescription is common in both assessed units. The observed percentage of off label prescription was higher than that reported by European studies carried out in primary care. On the other hand, the prescription of drugs not approved for children was not observed.
format Online
Article
Text
id pubmed-4795716
institution National Center for Biotechnology Information
language English
publishDate 2016
publisher Sociedade de Pediatria de São Paulo
record_format MEDLINE/PubMed
spelling pubmed-47957162016-04-01 Frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in a southern municipality of Brazil Gonçalves, Marcele Giacomin Heineck, Isabela Rev Paul Pediatr Original Articles OBJECTIVE: To determine the frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in medium-sized municipality of Rio Grande do Sul, Brazil. METHODS: Cross-sectional study with retrospective data collection, which analyzed prescriptions issued to 326 patients from August to December/2012 in two basic health units in the city of Viamão, state of Rio Grande do Sul. It included all prescriptions of patients whose medical records or service records were available and complete in relation to the date of presence, weight and date of birth. Off-label prescriptions were those which, in relation to the drug leaflet, showed dose different the recommended range, frequency of prescription and/or different form of administration and younger age than the indicated range. Descriptive statistics with absolute frequencies, means and standard deviations were used. RESULTS: During the study period, a total of 731 drug prescriptions were issued and the frequency of off-label medications prescribed was 31.7%, especially antihistamines and antiasthmatics (32.3% and 31.5%, respectively). The main type of off-label prescription was dose (38.8%), followed by age range (31.5%) and frequency of administration (29.3%). Regarding the dose off-label prescription, overdose was more frequent (93.3%) than the underdose (6.7%). Prescriptions of unapproved drugs were not identified. CONCLUSIONS: The study showed that off label prescription is common in both assessed units. The observed percentage of off label prescription was higher than that reported by European studies carried out in primary care. On the other hand, the prescription of drugs not approved for children was not observed. Sociedade de Pediatria de São Paulo 2016 /pmc/articles/PMC4795716/ /pubmed/26530249 http://dx.doi.org/10.1016/j.rppede.2015.06.023 Text en © 2015 Sociedade de Pediatria de São Paulo. Published by Elsevier Editora Ltda http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Articles
Gonçalves, Marcele Giacomin
Heineck, Isabela
Frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in a southern municipality of Brazil
title Frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in a southern municipality of Brazil
title_full Frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in a southern municipality of Brazil
title_fullStr Frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in a southern municipality of Brazil
title_full_unstemmed Frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in a southern municipality of Brazil
title_short Frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in a southern municipality of Brazil
title_sort frequency of prescriptions of off-label drugs and drugs not approved for pediatric use in primary health care in a southern municipality of brazil
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4795716/
https://www.ncbi.nlm.nih.gov/pubmed/26530249
http://dx.doi.org/10.1016/j.rppede.2015.06.023
work_keys_str_mv AT goncalvesmarcelegiacomin frequencyofprescriptionsofofflabeldrugsanddrugsnotapprovedforpediatricuseinprimaryhealthcareinasouthernmunicipalityofbrazil
AT heineckisabela frequencyofprescriptionsofofflabeldrugsanddrugsnotapprovedforpediatricuseinprimaryhealthcareinasouthernmunicipalityofbrazil