Skrinska-Kirilova Veselina, Sawchik Javier, Sabbe Martine, Debacker Martine, Weber Guy, Vuillemin Anne-Cécile, Hamdani Jamila
Ministry of Health and Social Security, Directorate of Health, Division of Pharmacy and Medicines (DPM-DISA), Rue Thomas Edison 2, L-1445, Strassen, Luxembourg.
Federal Agency for Medicines and Health Products (FAMHP), DG Post Authorisation, Avenue Galilée 5/03, 1210, Brussels, Belgium.
Drugs Real World Outcomes. 2025 Sep;12(3):425-435. doi: 10.1007/s40801-025-00508-8. Epub 2025 Jul 26.
Topical 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.
The 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.
A 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.
In 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.
The 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.
外用酮洛芬凝胶（法斯通凝胶）用于治疗风湿性和创伤性肌肉骨骼疼痛。继光敏反应报告之后，欧洲已实施额外的风险最小化措施，以告知医疗保健专业人员（HCPs）和患者这一风险。
我们调查的主要目的是评估HCPs对法斯通凝胶相关光敏风险的认知，以及他们对在比利时和卢森堡进行年度直接医疗保健专业人员沟通（DHPC）的有用性的看法。
在2023年6月至7月期间进行了一项横断面在线调查，即年度DHPC分发后约1个月。目标HCPs被问及他们对法斯通凝胶相关光敏风险的认知，以及他们对年度DHPC有用性的看法。该研究还探讨了接收信息的渠道，以及对教育材料的认知和使用情况。计算了每个国家总体以及按HCP类别划分的频率和百分比。
在比利时，569名HCPs回复了调查。几乎所有HCPs都报告称他们知晓这一风险（99%）。超过一半的药剂师（58%）和一半的医生（50%）表示年度DHPC是必要的。约一半的受访者（49%）回忆起在2023年收到过有关该风险的信息，主要是通过DHPC（68%），同时还提到了其他渠道，如包装上的标识（42%）和产品特性摘要（40%）。对患者卡片（32%）和检查表（5%）的认知总体较低，在2023年的使用非常有限。在卢森堡，190名HCPs回复了调查。几乎所有HCPs都报告称他们知晓这一风险（97%）。大多数药剂师（70%）和超过一半的医生（52%）支持年度DHPC分发。超过三分之二的受访者（68%）回忆起在2023年收到过相关信息，主要是通过DHPC（70%），但也通过产品特性摘要（30%）。对患者卡片（22%）和检查表（13%）的认知总体较低，在2023年的使用非常有限。
结果表明参与调查的HCPs对法斯通凝胶的光敏风险认知程度较高。值得注意的是，大多数HCPs表示需要年度DHPC。这项研究还强调了使用多种信息渠道以增加接触HCPs机会的重要性。然而，调查显示HCPs对检查表和患者卡片的使用有限。
