Evidence map›Paper›PMID 26530249›Full record

ArticleRevista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo

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

Marcele Giacomin Gonçalves, Isabela Heineck

Abstract read
In one paragraph

Article in Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Article
  2. Observational
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Relation between safe use of medicines and Clinical Pharmacy Services at Pediatric Intensive Care Units.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2016
    Article
  11. Adverse drug events in pediatric intensive care are common, but improvement strategies exist and are effective.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2016
    Article
  12. [Challenges on off label medicine use].Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Marcele Giacomin GonçalvesFaculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brasil. Electronic address: marcele_gg@yahoo.com.br.
Isabela HeineckFaculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brasil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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.

methodsCross-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.

resultsDuring 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.

conclusionsThe 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.

Indexed as

Age FactorsBrazilChildChild, PreschoolCross-Sectional StudiesDrug-Related Side Effects and Adverse ReactionsHumansInfantOff-Label UsePharmaceutical PreparationsPrimary Health CareRetrospective StudiesPharmaceutical PreparationsAtenção primária à saúdeMedication usePediatriaPediatricsPrimary health careUso de medicamentos

Identifiers

PMID26530249
PMCPMC4795716

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.