Evidence map›Paper›PMID 12634986›Full record

ArticleEuropean journal of clinical pharmacology2003

Widespread off-label prescribing of topical but not systemic drugs for 350,000 paediatric outpatients in Stockholm.

Mike Ufer, Anders Rane, Ake Karlsson, Elin Kimland, Ulf Bergman

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in European journal of clinical pharmacology, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
8.4field-weighted citation impact, top 3% of its field
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

11 citing papers in PubMed, 45 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Clinical symptoms and 'off-label' prescribing in children with asthma.The British journal of general practice : the journal of the Royal College of General Practitioners · 2007
    Article
  8. A literature review on off-label drug use in children.European journal of pediatrics · 2005
    Review
  9. Article
  10. Article
  11. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Mike UferDivision of Clinical Pharmacology, WHO Collaborating Centre for Drug Utilisation Research and Clinical Pharmacological Services, Karolinska Institute, Huddinge University Hospital, 14186, Stockholm, Sweden.
Anders Rane
Ake Karlsson
Elin Kimland
Ulf Bergman
Karolinska Institutet · SEStockholm County Council · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesMany hospital-based studies throughout Europe have shown that a substantial number of children receive off-label prescribed drugs that lack marketing authorisation for paediatric use. Since information about the extent and characteristics of this prescribing pattern in paediatric primary health care is limited, we assessed the proportion of off-label drug prescribing for paediatric outpatients in a reference population of 350,000 children using a computerised prescription database. We also determined the adherence to a treatment guideline provided by the Stockholm county council as a quality of prescribing indicator.

methodsAll drugs prescribed for children younger than 16 years of age in the Stockholm county in the year 2000 were ranked by the number of prescription items. The retrospective, descriptive analysis was restricted to those drugs that accounted for 90% of total prescribing. We calculated the proportion of off-label drug prescribing for different age and therapeutic groups with respect to age, formulation and route of administration using the Swedish Physician's Desk Reference. The quality of prescribing was estimated as the proportion of prescription items corresponding to recommended drugs in the local treatment guideline Kloka Listan (The Wise List).

resultsAmong the 317 drugs accounting for 90% of total prescribing, 575,526 prescription items were identified with an average proportion of off-label and recommended drug prescribing of 20.7% and 60.5%, respectively. The off-label proportion was similar in various age groups but widely different between therapeutic groups being much higher for topical (70.4%) than for systemic (5.4%) drugs. The extent to which recommended drugs were prescribed also greatly varied between therapeutic groups irrespectively of the off-label proportion.

conclusionsOff-label drug prescribing for paediatric outpatients is a common phenomenon. However, it mainly applied to topical drugs and was to a substantial extent recommended by the local treatment guideline. Thus, off-label prescribing might represent a more administrative rather than clinical problem in the paediatric outpatient setting.

Indexed as

Administration, TopicalAdolescentChildChild, PreschoolDrug LabelingDrug PrescriptionsDrug UtilizationFemaleHumansInfantMaleOutpatientsPharmaceutical PreparationsPractice Guidelines as TopicSwedenPharmaceutical Preparations

Identifiers

PMID12634986
OpenAlexW195996435

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.