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Off-label use of orphan medicinal products: a Belgian qualitative study

Overview of attention for article published in Orphanet Journal of Rare Diseases, October 2016
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  • In the top 25% of all research outputs scored by Altmetric
  • Good Attention Score compared to outputs of the same age (72nd percentile)
  • Above-average Attention Score compared to outputs of the same age and source (63rd percentile)

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Title
Off-label use of orphan medicinal products: a Belgian qualitative study
Published in
Orphanet Journal of Rare Diseases, October 2016
DOI 10.1186/s13023-016-0507-y
Pubmed ID
Authors

Marc Dooms, David Cassiman, Steven Simoens

Abstract

Off-label use of (orphan) medicinal products for (rare) diseases is quite common but not underpinned by clinical studies to confirm efficacy and safety. No risk-analyses by regulatory agencies are carried out. The objective of this study was to map off-label use of orphan medicinal products in Belgium in terms of attitude towards off-label prescribing, factors influencing off-label prescribing, disclosure of information towards the patient, reporting of off-label use, risks and consequences. Most of the EMA authorized orphan drugs are fully reimbursed in Belgium under well-defined circumstances. Moreover, a "Special Solidarity Fund" takes care of some specific cases eventually prescribed off-label. Semi-structured interviews with seven physicians with expertise in the treatment with and six experts in the reimbursement of orphan medicinal products in Belgium. This task was performed by five last-year pharmacy students after having studied profoundly the medical literature around off-label prescribing. They had no previous contact with the participants. Most participants do agree with the off-label use if the medicinal product is quite safe and well-tolerated, if the on-label indication is rather general and when all other options have failed in some specific, evidence-based indications, especially in children. Before starting off-label use, the patient/family needs to be fully and clearly informed. The treatment is not reimbursed but sometimes sponsored by the company or by charity funds. Reporting of the outcome is necessary to avoid losing valuable information. The prescriber is responsible and can be held accountable. While there is support from physicians and reimbursement experts, there is also concern in case of off-label use, mainly for reasons of patient safety especially when medicinal products are prescribed off-label in the absence of medical or scientific justification and driven by cost-containment motives.

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X Demographics

The data shown below were collected from the profiles of 8 X users who shared this research output. Click here to find out more about how the information was compiled.
Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 71 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 71 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 14 20%
Researcher 8 11%
Student > Bachelor 8 11%
Student > Ph. D. Student 7 10%
Other 5 7%
Other 9 13%
Unknown 20 28%
Readers by discipline Count As %
Pharmacology, Toxicology and Pharmaceutical Science 17 24%
Medicine and Dentistry 10 14%
Nursing and Health Professions 7 10%
Social Sciences 5 7%
Biochemistry, Genetics and Molecular Biology 3 4%
Other 7 10%
Unknown 22 31%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 6. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 20 September 2021.
All research outputs
#5,716,700
of 23,198,445 outputs
Outputs from Orphanet Journal of Rare Diseases
#713
of 2,663 outputs
Outputs of similar age
#85,980
of 314,709 outputs
Outputs of similar age from Orphanet Journal of Rare Diseases
#15
of 41 outputs
Altmetric has tracked 23,198,445 research outputs across all sources so far. Compared to these this one has done well and is in the 75th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 2,663 research outputs from this source. They typically receive more attention than average, with a mean Attention Score of 7.6. This one has gotten more attention than average, scoring higher than 72% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 314,709 tracked outputs that were published within six weeks on either side of this one in any source. This one has gotten more attention than average, scoring higher than 72% of its contemporaries.
We're also able to compare this research output to 41 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 63% of its contemporaries.