Drugs - Real World Outcomes最新文献

{"title":"Association of Acetaminophen Access on Adolescent Self-poisoning in South Korea.","authors":"Hee Yeon Kay, Young Hee Kwon, Hyun Ik Kim","doi":"10.1007/s40801-025-00521-x","DOIUrl":"https://doi.org/10.1007/s40801-025-00521-x","url":null,"abstract":"<p><strong>Background: </strong>Acetaminophen is a commonly used analgesic and antipyretic. In South Korea, a 2012 regulatory change allowed its over-the-counter sale in convenience stores, increasing public accessibility.</p><p><strong>Objectives: </strong>We aimed to assess the impact of increased over-the-counter availability of acetaminophen on adolescent self-poisoning trends in South Korea.</p><p><strong>Methods: </strong>This population-based observational study used the National Health Insurance Service customized database to analyze trends in acetaminophen-related poisoning among adolescents before and after the 2012 policy change. Age-specific trends were evaluated, and poisoning episodes were categorized by recurrence and severity.</p><p><strong>Results: </strong>Following the policy change, the number of acetaminophen poisoning cases increased from 2.4 to 3.8 (during 2007-11 and 2013-17, respectively, per 100,000 adolescents). This increase was particularly significant among adolescents aged 16-18 years, rising from 10.7 to 23.8 per 100,000 (p < 0.05). While the total number of poisoning events increased, the number of affected individuals remained largely unchanged (86.4 vs 80.0), suggesting a more frequent recurrence. The proportion of acetaminophen poisonings among all drug poisoning cases increased from 5.2% to 9.7%, whereas the increase in the proportion of severe cases requiring hospitalization was relatively modest.</p><p><strong>Conclusions: </strong>The findings suggest that increased over-the-counter availability of acetaminophen may be associated with a rise in misuse among older adolescents. Public health measures, including stricter over-the-counter regulation and targeted interventions, may be needed to mitigate the risk of self-harm in this population.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145250405","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost Differences Between Oral Anticoagulation Therapies in Patients with Atrial Fibrillation in Finland.","authors":"Ossi Lehtonen, Olli Halminen, K E Juhani Airaksinen, Jari Haukka, Jukka Putaala, Pirjo Mustonen, Konsta Teppo, Elis Kouki, Aapo L Aro, Juha Hartikainen, Mika Lehto, Miika Linna","doi":"10.1007/s40801-025-00519-5","DOIUrl":"https://doi.org/10.1007/s40801-025-00519-5","url":null,"abstract":"<p><strong>Background: </strong>The cost burden of new-onset atrial fibrillation (AF) has not previously been studied with unselected nationwide data.</p><p><strong>Objective: </strong>We analyzed differences in the distribution and time course of costs from all categories of healthcare services in patients receiving direct oral anticoagulants (DOACs), warfarin, or no anticoagulation during the first year following diagnosis of AF.</p><p><strong>Methods: </strong>This sub-study of the Finnish AntiCoagulation in Atrial Fibrillation (FinACAF) project comprised all new-onset AF patients from 2011 to 2017 in Finland with an indication for oral anticoagulation treatment. The registry data included information on primary and secondary care services as well as social care services, drug purchases, laboratory data, and reimbursed private care and travel services. We report inverse probability of treatment weighted average costs for different pharmaceutical groups with bootstrapped confidence intervals.</p><p><strong>Results: </strong>In total, 130,745 patients (66,610 on warfarin, 32,996 on DOACs) were included. Weighted first-year costs after onset of AF were €11,364 for rivaroxaban (n = 13,230), €12,642 for apixaban (n = 11,886), €11,403 for dabigatran (n = 7514), and €10,752 for edoxaban (n = 366). Costs were clustered near the diagnosis of AF. Costs for warfarin patients were inversely related to the quality of anticoagulation therapy. Average first-year costs for warfarin patients were €15,860, higher than for patients on DOACs by €3218-€5108. Patients without any oral anticoagulation had the highest first-year costs, €17,682. Patients with high risk of stroke had higher total costs, both in patients using DOACs and warfarin.</p><p><strong>Conclusions: </strong>DOACs had lower total costs than warfarin despite higher drug expenses. Patients without any oral anticoagulation had the highest costs.</p><p><strong>Clinicaltrials identifier: </strong>NCT04645537.</p><p><strong>Encepp identifier: </strong>EUPAS29845.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145244007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Persistence of Weekly Injectable Semaglutide Use in Patients with Diabetes Mellitus and Obesity: A Retrospective Follow-Up in Colombia.","authors":"Manuel Enrique Machado-Duque, Andrés Gaviria-Mendoza, Luis Fernando Valladales-Restrepo, Jorge Enrique Machado-Alba","doi":"10.1007/s40801-025-00518-6","DOIUrl":"https://doi.org/10.1007/s40801-025-00518-6","url":null,"abstract":"<p><strong>Background: </strong>Semaglutide is an effective antidiabetic agent that is injected weekly to induce weight reduction, and the impact on cardiovascular outcomes is favorable.</p><p><strong>Objective: </strong>The aim was to evaluate the persistence of the use of weekly injectable semaglutide in Colombia for 12 months among new users.</p><p><strong>Methods: </strong>A retrospective longitudinal follow-up study of a cohort of patients with a new prescription of weekly injectable semaglutide between January and December 2022 and persistence for 365 days was evaluated. Kaplan‒Meier survival analyses were performed to evaluate the survival effect of semaglutide.</p><p><strong>Results: </strong>In total, 9356 new users of semaglutide were identified. The average age of the users was 61.6 ± 12.9 years, the main diagnoses were type 2 diabetes mellitus (43.8%) and obesity (41.8%), and 90.8% of them received the 0.25/0.5-mg dose. The mean duration of use was 93.7 ± 76.3 days, but only 13.8% and 0.2% of patients continued the treatment at 6 and 12 months of follow-up, respectively. In total, 35.4% had a prescription for a single month. The other concomitant antidiabetic drugs used were metformin (43.5%), sodium glucose-2 cotransporter inhibitors (38.3%) and insulin (18.2%).</p><p><strong>Conclusions: </strong>Most of the patients started semaglutide at the suggested doses to continue with staging; however, the persistence of use was low, which may be related to difficulties in access, education on application methods, drug tolerability, and lack of follow-up by the clinician.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145211969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of Dysphagia-Inducing Drugs and Risk of Aspiration Pneumonia: A Cross-Sectional Analysis Using a Japanese Claims Database.","authors":"Naoko Hayashi, Mari Yoshida, Narumi Maida, Shingo Kondo, Masanori Ogawa, Hiroki Iwata, Noriko Kobayashi, Katsunori Yamaura","doi":"10.1007/s40801-025-00517-7","DOIUrl":"https://doi.org/10.1007/s40801-025-00517-7","url":null,"abstract":"<p><strong>Background and objectives: </strong>Oropharyngeal dysphagia (OD), a dysfunction in swallowing food or drink, can result from various diseases and adverse drug reactions. OD is a risk factor for aspiration pneumonia (AP). However, the specific drugs causing OD and their incidence rates are not fully understood. This study aimed to identify drugs associated with OD, their incidence rates, and AP risk factors in patients taking these drugs on the basis of the information provided in package inserts.</p><p><strong>Methods: </strong>This study identified candidate dysphagia-inducing drugs (CDIDs) from Japanese package inserts that listed OD as an adverse reaction. The age, sex, medications, and comorbidities of patients taking CDIDs were analyzed using the JammNet insurance database, purchased from JammNet Co., Ltd. (Tokyo, Japan).</p><p><strong>Results: </strong>Overall, 54 ingredients were identified as CDIDs. Out of 24,276 patients taking CDIDs, 146 (0.6%) were diagnosed with OD and 76 (0.3%) with AP. Among those with AP, 23 patients (30%) also had OD. OD or AP occurred in patients taking 28 (52%) of the 54 target ingredients. In addition, 13 ingredients had an adverse reaction incidence of 1% or greater for either condition. The top five CDIDs with the highest incidence rates for each diagnosis were clobazam, baclofen, zonisamide, tiapride hydrochloride, and topiramate. Incidence rates of OD and AP were significantly higher with multiple CDIDs than with a single drug (p < 0.05). Logistic regression analysis showed that AP occurrence was significantly associated with males, late-stage elderly individuals, a diagnosis of OD, and constipation.</p><p><strong>Conclusions: </strong>The results of this study suggest that careful attention should be given to the risk of AP when prescribing CDIDs, particularly for elderly male patients.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145091376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tyrosine Kinase Inhibitors and Interstitial Lung Disease: A Disproportionality Analysis Using the European Post-marketing EudraVigilance Database.","authors":"Devron R Shah, Simon P Hart, Dominic L Sykes","doi":"10.1007/s40801-025-00515-9","DOIUrl":"https://doi.org/10.1007/s40801-025-00515-9","url":null,"abstract":"<p><strong>Background: </strong>Increasing global frequency of drug-induced interstitial lung disease (ILD) coincides with increasing market introduction of tyrosine kinase inhibitors (TKIs).</p><p><strong>Objectives: </strong>The aim was to detect disproportional reporting of TKI-induced ILD in the EudraVigilance post-marketing safety database and to scrutinise the prescribing information of these TKIs.</p><p><strong>Methods: </strong>Data were gathered on the number of total and individual ILD case safety reports for each TKI marketed in the European Union (EU), together with indications and patient demographics. Information was also obtained on numbers of total and ILD reports for all drugs in the entire database, covering the period January 2002 to March 2024. Chi-squared analyses and two measures of disproportionality, the proportional reporting ratio (PRR) and reporting odds ratio (ROR), were used to ascertain the ILD-inducing potential of TKIs, both as a group and with each TKI individually. The latest prescribing information for each TKI was evaluated for ILD-related information.</p><p><strong>Results: </strong>TKIs were collectively associated with a significantly stronger disproportionality signal for ILD reports compared to all non-TKI drugs (p < 0.001). There was marked variation in the disproportionality of ILD reporting across the 51 TKIs studied. Potential risk factors included male gender (p < 0.001), age 65-85 years (p < 0.001) and an oncological indication (p < 0.001), particularly non-small cell lung cancer (NSCLC). Fatality rates among cases of TKI-induced ILD were 17.4% overall, 22.2% in patients with NSCLC and 11.5% in those with a non-oncological indication. The prescribing information of 11 TKIs lacked any reference to ILD despite a strong signal that indicated their potential association with ILD.</p><p><strong>Conclusions: </strong>Drug-induced ILD is emerging as an important safety issue, and physicians need to maintain a high index of suspicion of ILD in patients treated with a TKI.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding Underreporting of Adverse Drug Reactions in the Philippines: A Mixed Methods Study.","authors":"Mark Ryann A Lirasan, Mark Harvey B Adamson, Vieno Gino Cruz, Julie Ann T Capuchino, Leslee Ann Lorna D De Jesus, Roland Amiel C Peñaloza, Jover D Francisco, Maureen Allysandra G Gulmatico, John Eric R Valiente, Maria Glezilda R Soriano, Rizza Ann A Oquendo","doi":"10.1007/s40801-025-00492-z","DOIUrl":"10.1007/s40801-025-00492-z","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Adverse drug reaction (ADR) reporting is a crucial element in ensuring medication safety and effective pharmacovigilance. However, underreporting of ADRs remains a significant challenge in the Philippines despite efforts made by the national pharmacovigilance center (NPVC). This study aims to explore the factors contributing to underreporting of ADRs among healthcare professionals (HCPs) in the Philippines, with a focus on understanding their knowledge, attitudes, and practices (KAP), as well as evaluating the usability of the online ADR reporting system.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A mixed-methods approach was employed, integrating quantitative and qualitative research methods. The study involved a KAP survey and focus group discussions (FGDs) with HCPs, including pharmacists, nurses, and physicians. The survey gathered quantitative data on KAP related to ADR reporting, while FGDs provided qualitative insights into contextual factors, misconceptions, and barriers. In addition, a system usability survey (SUS) was conducted among participants at the 1st Philippine Pharmacovigilance Summit to assess the usability of the online ADR reporting system. Data collection spanned 4 weeks, followed by thematic analysis of FGD data and descriptive statistical analysis of survey and SUS data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study revealed that HCPs generally recognize the importance of ADR reporting for FDA-approved drugs, vaccines, and antineoplastics, but there is a knowledge gap regarding the reporting of FDA-unapproved drugs. Awareness of the NPVC is limited, with less than half of HCPs (n = 4363) aware of its existence, and even fewer understanding its roles. Reporting practices are inconsistent, with many relying on paper-based methods, and a significant portion of HCPs are unaware of available reporting options. While 71.08% of participants expressed a high likelihood of reporting ADRs if familiar with the process, only 21.54% had actually reported one. Thematic analysis from focus group discussions identified several barriers to effective ADR reporting, including insufficient training, inconsistent practices, fear of legal repercussions, and low adoption of digital tools. The SUS results showed an \"okay\" usability rating for the online ADR reporting system, with a score of 68.81 (grade C). This shows that while many users found the tool acceptable and fairly easy to use, nearly half of the respondents felt it was too complex.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study reveals significant knowledge gaps among HCPs in the Philippines regarding ADR reporting. While HCPs acknowledge the importance of ADR reporting for patient safety, many perceive the process as complex and burdensome, which discourages consistent participation. The study highlights key barriers, including legal concerns and complexity of online reporting tools. A key policy implication is the need for government agencies, such as the Food and D","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"367-381"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381321/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144186783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacy Dispensing Records to Describe and Evaluate the Use of Acetylcholinesterase Inhibitors Among Swedish Antipsychotic Drug Users with Symptoms of Lewy Body Dementia.","authors":"Jonas Kindstedt, Hugo Lövheim, Maria Gustafsson","doi":"10.1007/s40801-025-00501-1","DOIUrl":"10.1007/s40801-025-00501-1","url":null,"abstract":"<p><strong>Introduction: </strong>People with Lewy body dementia (LBD) experience pronounced psychotic symptoms but are extremely sensitive to side effects from antipsychotic treatment. In comparison, acetylcholinesterase inhibitors (AChEIs) are a safer treatment option for managing cognitive and neuropsychiatric symptoms and should ideally be the first-line treatment according to review literature. This study described the pharmacological treatment of LBD-associated neuropsychiatric symptoms among older people by comparing dispensing records of antipsychotic drugs and AChEIs.</p><p><strong>Methods: </strong>This study included people with records of antipsychotic drugs dispensed in 2019 according to the Swedish Prescribed Drug Register, which functioned as an indicator of neuropsychiatric symptoms, who had been registered with LBD in the Swedish registry for cognitive/dementia disorders according to basal registrations from 2007 to 2020. We then determined the proportions of individuals with and without dispensing records of AChEIs prescribed before their index antipsychotic prescription fill of 2019, by comparing prescribing dates. Age, sex and nursing home residency were included as independent variables in a multiple logistic regression model to analyse associations between demographic factors and first-line treatment with AChEIs.</p><p><strong>Results: </strong>In total, 362 individuals with symptoms of LBD had filled at least one prescription for any antipsychotic drug in 2019. There were 114 people (31.5%) who had been prescribed antipsychotics as first-line treatment instead of AChEIs, and among them, 60 individuals had been diagnosed with LBD after the index antipsychotic prescribing date. First-line treatment with AChEIs was more common among males (odds ratio, OR, 1.65 [95% CI 1.03-2.62]) and nursing home residents (2.51 [1.59-3.96]).</p><p><strong>Conclusions: </strong>Antipsychotics were utilized as first-line treatment instead of AChEIs among almost one-third of antipsychotic users with symptoms of LBD. It is important to consider emerging psychotic symptoms among older people as possible manifestations of LBD to ensure early and appropriate pharmacological treatment.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"383-390"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381332/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144191644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Estimating Risks of Central Nervous System Disturbance Associated with Medications for Herpes Zoster: Findings from a Regional Population-Based Cohort Study Using the Shizuoka Kokuho Database.","authors":"Ryoya Hagiwara, Eiji Nakatani, Hideaki Kaneda, Hiroshi Okada, Hideo Hashizume, Nagato Kuriyama, Akira Sugawara","doi":"10.1007/s40801-025-00500-2","DOIUrl":"10.1007/s40801-025-00500-2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Herpes zoster commonly occurs in older adults, whose renal function often declines, necessitating careful dosing of antivirals such as acyclovir, valacyclovir, and famciclovir. Insufficient dose adjustment can increase central nervous system (CNS) disturbance risk. Although previous reports show varying neurotoxic risk among these drugs, the safety profiles of these drugs remain underexplored. CNS disturbance significantly impacts quality of life, but it is rare and primarily documented through case reports, with little thorough investigation or comparison across drugs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to evaluate the potential risks of CNS disturbance associated with acyclovir and valacyclovir compared with famciclovir in patients with herpes zoster, highlighting the potential influence of renal function and dose adjustments.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a population-based cohort study using data from the National Health Insurance and the Late-Stage Medical Care System for the Elderly in Japan, including patients diagnosed with herpes zoster and newly prescribed oral or intravenous antiviral drugs between April 2012 and September 2021. The outcome was defined as the occurrence of CNS disturbance within 1 month from the index date. Patients with neurological, infectious or psychiatric disorders during the 1-year baseline period were excluded. The incidence of CNS disturbance with 95% confidence intervals (CIs) was compared between dialysis and nondialysis patients, owing to incomplete renal function data. In addition, we compared the incidence of CNS disturbance among groups using propensity score matching to adjust for confounders, with famciclovir users as the control group. Postmatching, risk differences with 95% CIs, and number needed to harm (NNH) were calculated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The final cohort consisted of 82,646 patients (8646 acyclovir, 46,643 valacyclovir, and 27,357 famciclovir users). Severe renal dysfunction was associated with CNS disturbance. The CNS disturbance incidence was 0.33% in nondialysis and 2.29% (risk difference 1.96%, 95% CI [0.39-3.53]) in dialysis patients using acyclovir/valacyclovir versus 0.18% and 0.60% (risk difference 0.42%, 95% CI [- 0.76 to 1.6]) for famciclovir, respectively. After propensity score matching, CNS disturbances were observed in 0.50% of patients in the acyclovir group versus 0.17% in the famciclovir group and in 0.29% of patients in the valacyclovir group versus 0.17% in the famciclovir group. The risk of CNS disturbance remained higher in both the acyclovir group (risk difference 0.33%, 95% CI [0.16-0.51], NNH 278) and the valacyclovir group (0.12%, [0.04-0.19], 833) compared with the famciclovir group.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Acyclovir and valacyclovir, when compared with famciclovir, are associated with an increased risk of CNS disturbance in patients with herpes zoster, particularly among those with","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"399-410"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12380658/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Awareness of Photosensitivity Risk and Additional Risk Minimisation Measures for Ketoprofen Gel in Belgium and Luxembourg.","authors":"Veselina Skrinska-Kirilova, Javier Sawchik, Martine Sabbe, Martine Debacker, Guy Weber, Anne-Cécile Vuillemin, Jamila Hamdani","doi":"10.1007/s40801-025-00508-8","DOIUrl":"10.1007/s40801-025-00508-8","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"425-435"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381325/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144728720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association Between Vaccination for Human Papillomavirus (HPV) and Autonomic Dysfunction and Menstrual Irregularities: A Self-Controlled Case Series Analysis.","authors":"Linda Wastila, Yu-Hua Fu, Chih Chun Tung, Danya M Qato","doi":"10.1007/s40801-025-00504-y","DOIUrl":"10.1007/s40801-025-00504-y","url":null,"abstract":"<p><strong>Background: </strong>Limited research has addressed safety concerns related to vaccination against the human papillomavirus (HPV).</p><p><strong>Objective: </strong>To investigate the association between receipt of HPV vaccination and autonomic dysfunction and menstrual irregularities in girls and young women.</p><p><strong>Methods: </strong>Using a 25% random sample of IQVIA PharMetrics^® Plus for Academics claims database from 2016 to 2020, we conducted a self-controlled case series study in commercially insured girls and young women receiving their first HPV vaccine dose (analyses conducted between March 2024 and April 2025). Incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were estimated for two outcomes-autonomic dysfunction and menstrual irregularities. We conducted further analyses stratified by number of HPV vaccine doses received per beneficiary and by age (9-17 years vs. 18-26 years), as well as adjusted for age as a time-varying covariate. The IRRs were estimated over a maximum risk case post-vaccination period of 36 months compared to a 6-month within-person control pre-vaccination period.</p><p><strong>Results: </strong>There were 1654 individuals in the autonomic dysfunction cohort and 3140 individuals in the menstrual irregularities cohort. When adjusted for age, HPV vaccination was associated with elevated IRRs for autonomic dysfunction (IRR 1.23; 95% CI 1.08-1.41) and menstrual irregularities (IRR 1.30; 95% CI 1.18-1.43). IRRs for individual outcomes varied by age group, with the younger cohort showing a significantly higher age-adjusted IRR than the older cohort for menstrual irregularities (IRR 1.51; 95% CI 1.33-1.72 vs. IRR 1.15; 95% CI 0.99-1.33, respectively). Although the risk of experiencing autonomic dysfunction was not significant in the adjusted younger cohort, young women aged 18-26 years had a heightened age-adjusted risk (IRR 1.40; 95% CI 1.12-1.75). Findings from the dose-response analysis were inconclusive.</p><p><strong>Conclusions: </strong>HPV vaccination is associated with elevated risks of autonomic dysfunction and menstrual irregularities, which vary by age. Further research is needed to identify additional risk factors associated with HPV vaccination safety.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"467-477"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381344/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}