Does the EU’s Paediatric Regulation work for new medicines for children in Denmark, Finland, Norway and Sweden? A cross-sectional study
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ABSTRACT: Objective
The aim of this study was to assess the marketing status of the new paediatric medicinal products listed in the 10-year report as initially authorised between 2007 and 2016, reflecting the product availability in four Nordic countries. Design
This is a cross-sectional study. Setting
Analysis of the national medicine agency’s databases in Denmark, Finland, Norway and Sweden. Data source
New medicinal products with paediatric indications and new paediatric formulations listed in the Annex of European Medicines Agency’s EU Paediatric Regulation 10-year report. Data analysis
The products were classified according to national marketing status between January 2019 and March 2019, whether a product was authorised and whether the product was marketed. Main outcome measures
The percentages of the new medicinal products with paediatric indications and new paediatric formulations having a valid marketing authorisation and being marketed, both in terms of the sums of all countries and separately for each country. Results
Across the four countries, 21%–32% (16/76–24/76) of the new medicinal products were not marketed. Of the new formulations relevant to children, 29%–50% (16/56–28/56) were not marketed, and a significant proportion of these products had never been marketed. Conclusions
This study reflects the reality of the implementation of the Paediatric Regulation. The results show that several new paediatric medicines and new formulations are not marketed. This affects the product availability. Similar data from other countries are needed to evaluate the overall European status to find remedies to current situation and increase the availability of the medicines for children.
SUBMITTER: Lepola P
PROVIDER: S-EPMC7780531 | biostudies-literature | 2020 Jan
REPOSITORIES: biostudies-literature
Similar Datasets
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Project description:ObjectivesThe aim of this study was to investigate the association between multiple lifestyle-related risk factors (unhealthy diet, low leisure-time physical activity, overweight/obesity and smoking) and self-rated work ability in a general working population.SettingPopulation-based cross-sectional study, in Telemark County, Norway, 2013.ParticipantsA random sample of 50?000 subjects was invited to answer a self-administered questionnaire and 16?099 responded. Complete data on lifestyle and work ability were obtained for 10?355 participants aged 18-50 years all engaged in paid work during the preceding 12 months.Outcome measureWork ability was assessed using the Work Ability Score (WAS)-the first question in the Work Ability Index. To study the association between multiple lifestyle risk factors and work ability, a lifestyle risk index was constructed and relationships examined using multiple logistic regression analysis.ResultsLow work ability was more likely among subjects with an unhealthy diet (ORadj 1.3, 95%?CI 1.02 to 1.5), inactive persons (ORadj 1.4, 95%?CI 1.2 to 1.6), obese respondents (ORadj 1.5, 95%?CI 1.3 to 1.7) and former and current smokers (ORadj 1.2, 95%?CI 1.1 to 1.4 and 1.3, 95%?CI 1.2 to 1.5, respectively). An additive relationship was observed between the lifestyle risk index and the likelihood of decreased work ability (moderate-risk score: ORadj 1.3; 95% CI 1.1 to 1.6; high-risk score: ORadj 1.9; 95% CI 1.6 to 2.2; very high risk score: ORadj 2.4; 95% CI 1.9 to 3.0). The overall population attributable fraction (PAF) of low work ability based on the overall risk index was 38%, while the PAFs of physical activity, smoking, body mass index and diet were 16%, 11%, 11% and 6%, respectively.ConclusionsLifestyle risk factors were associated with low work ability. An additive relationship was observed. The findings are considered relevant to occupational intervention programmes aimed at prevention and improvement of decreased work ability.
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Project description:BackgroundPopulation-based cohorts of immune thrombocytopenia (ITP) are useful for understanding occurrence, clinical characteristics and long-term clinical course. This paper describes the content of the Nordic Country Patient Registry for Romiplostim (NCPRR) and provides prevalence and incidence estimates of chronic ITP (cITP).MethodsThe NCPRR, a cohort study established in 2009, includes all adult (≥ 18 years) patients in Denmark, Sweden and Norway with cITP (defined as ITP lasting > 12 months and platelet count < 100 × 109/L), combining data from national health registries and medical records. The NCPRR currently includes prevalent cITP patients diagnosed before 2009 and incident cITP patients diagnosed during 2009-2016. The registry obtains clinical information for cITP patients, including comorbidities, treatments, laboratory values, and complete follow-up for various outcomes.FindingsThe NCPRR currently includes 3831 patients with cITP (1258 prevalent; 2573 incident). In 2009, the prevalence of registered cITP was 10 · 0/100,000 (95%CI:9 · 1-11 · 0) adult persons in Denmark and 10 · 7/100,000 (95% CI: 9 · 9-11 · 4) adults in Sweden. During 2009-2016, the incidence rates of cITP per 100,000 person-years were 2 · 8 (95%CI: 2 · 6-3 · 0), 1 · 8 (95%CI: 1 · 7-1 · 9) and 2 · 1 (95%CI: 1 · 9-2 · 2) in Denmark, Sweden and Norway, respectively. Fifty-eight percent of cITP patients were women. At NCPRR inclusion, 30.2% were aged ≥ 70 years, 23% had a platelet count < 50 × 109/L, 17.4% were splenectomized, 41% had prior ITP therapy, and 8.6% had severe comorbidity.InterpretationThe NCPRR provides population-based data on the epidemiology and characteristics of almost 4000 cITP patients and is a valuable resource for research.FundingThis study was partly funded by a research grant from Amgen to Aarhus University.
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