Evidence map›Paper›PMID 40715974›Full record

ArticleDrugs - real world outcomes2025

Evaluation of Awareness of Photosensitivity Risk and Additional Risk Minimisation Measures for Ketoprofen Gel in Belgium and Luxembourg.

Veselina Skrinska-Kirilova, Javier Sawchik, Martine Sabbe, Martine Debacker, Guy Weber, Anne-Cécile Vuillemin, Jamila Hamdani

Abstract read
In one paragraph

Article in Drugs - real world outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

7 authors.

Veselina Skrinska-Kirilova *Ministry of Health and Social Security, Directorate of Health, Division of Pharmacy and Medicines (DPM-DISA), Rue Thomas Edison 2, L-1445, Strassen, Luxembourg. veselina.skrinska-kirilova@ms.etat.lu.ORCID http://orcid.org/0009-0005-0380-7613
Javier Sawchik *Federal Agency for Medicines and Health Products (FAMHP), DG Post Authorisation, Avenue Galilée 5/03, 1210, Brussels, Belgium. javier.sawchik@fagg-afmps.be.ORCID http://orcid.org/0000-0002-7744-908X
Martine SabbeFederal Agency for Medicines and Health Products (FAMHP), DG Post Authorisation, Avenue Galilée 5/03, 1210, Brussels, Belgium.
Martine DebackerMinistry of Health and Social Security, Directorate of Health, Epidemiology and Statistics Unit (Service Épidémiologie et Statistique-DISA), Luxembourg, Luxembourg.
Guy WeberMinistry of Health and Social Security, Directorate of Health, Epidemiology and Statistics Unit (Service Épidémiologie et Statistique-DISA), Luxembourg, Luxembourg.
Anne-Cécile VuilleminMinistry of Health and Social Security, Directorate of Health, Division of Pharmacy and Medicines (DPM-DISA), Rue Thomas Edison 2, L-1445, Strassen, Luxembourg.
Jamila HamdaniFederal Agency for Medicines and Health Products (FAMHP), DG Post Authorisation, Avenue Galilée 5/03, 1210, Brussels, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTopical ketoprofen gel (Fastum gel) is used for the treatment of rheumatic and traumatic musculoskeletal pain. Following reports of photosensitivity reactions, additional risk minimisation measures have been implemented in Europe to inform healthcare professionals (HCPs) and patients about this risk.

objectiveThe main objectives of our survey were to assess both HCPs' awareness of the risk of photosensitivity associated with Fastum gel and their opinion on the usefulness of an annual direct healthcare professional communication (DHPC) in Belgium and Luxembourg.

methodsA cross-sectional online survey was conducted between June and July 2023, approximately 1 month after the annual distribution of the DHPC. Targeted HCPs were asked about their awareness of the photosensitivity risk associated with Fastum gel, as well as their opinion on the usefulness of the annual DHPC. The study also explored the channels through which the information was received, along with awareness and use of educational materials. Frequencies and percentages were calculated both overall and by HCP category for each country.

resultsIn Belgium, 569 HCPs responded to the survey. Almost all HCPs reported that they were aware of this risk (99%). More than half of pharmacists (58%) and half of physicians (50%) indicated that an annual DHPC is necessary. Around half of the respondents (49%) recalled receiving information about the risk in 2023, primarily through the DHPC (68%) while outlining other channels such as the logo on the packaging (42%) and the Summary of Product Characteristics (40%). Awareness of the patient card (32%) and the checklist (5%) was overall low, with very limited use in 2023. In Luxembourg, 190 HCPs responded to the survey. Almost all HCPs reported that they were aware of this risk (97%). The majority of pharmacists (70%) and more than half of physicians (52%) supported the annual DHPC distribution. Over two thirds of the respondents (68%) recalled receiving relevant information in 2023, mainly through the DHPC (70%) but also through the SmPC (30%). Awareness of the patient card (22%) and the checklist (13%) was overall low, with very limited use in 2023.

conclusionsThe results indicate a high level of awareness of the photosensitivity risk of Fastum gel among participating HCPs. Notably, a majority of HCPs expressed the need for an annual DHPC. This study also underscores the importance of using multiple channels of information to increase the opportunities for reaching HCPs. Nevertheless, the survey revealed limited use of the checklist and the patient card among HCPs.

Identifiers

PMID40715974
PMCPMC12381325

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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.