ObjectivesThe aim of this study was to investigate the use of off‐label (OL) and unlicensed (UL) medicines to hospitalised children in Norway, to add to the current knowledge on use of medicines in this vulnerable patient group.MethodsThe study was performed as a cross‐sectional prospective study. Medication was classified as on‐ or off‐label based on the comparison with the SmPC regarding age, indication, dosage, route of administration and handling of the product. UL products were classified as imported or pharmacy produced.Key findingsMore than 90% of children receiving medicines in our study were given OL or UL medicines. More patients received OL (83%) than UL (59%). Route of administration was the most frequently observed OL category. The vast majority of the OL prescriptions were for ‘off‐patent’ products. One‐third of products prescribed were UL.ConclusionsThe study confirms that medicines to children in hospital to a significant degree are being used outside or without authorisation, in spite of recent paediatric regulatory initiatives. More data are still needed on efficacy and safety of medicines used in children, data to be incorporated in the SmPC. In addition, suitable formulations are needed to ensure optimal dosing and adherence without risky manipulations.

Background and objectiveA comparison of sick leave in pregnancy between countries is difficult as most studies have been conducted in single countries in Scandinavia. The objective of this study was to explore patterns of and reasons for sick leave during pregnancy on a multinational level, focusing on medication use but also differences in sick leave policies.Design and settingCross-sectional, web-based study in 12 European countries from October 2011 to February 2012. Data were collected via an electronic questionnaire.ParticipantsPregnant women and mothers of children under the age of 1 year.Primary outcome measureSick leave prevalence in pregnancy.ResultsOf 6686 women included, 3385 (50.6%) had been on sick leave during pregnancy. The rates of sick leave varied across countries, ranging from 31.7%–34.8% in Sweden and the UK to 62.4%–71.3% in Norway, Serbia, Croatia and Poland. The most common reasons for being on sick leave were pregnancy complications (26.5%); pain in the neck, back or pelvic girdle (16.2%); and nausea and vomiting (NVP, 16.0%). Women using medications for acute illnesses were more likely to be on sick leave than their non-medicated counterparts, while an opposite trend was observed for women with chronic disorders, where non-medicated women were more likely to be on sick leave. Women from countries with ‘low’ sick leave policies were less likely to have extensions of sick leaves compared with women from countries with ‘medium’ policies (adjusted OR 0.63, 95% CI 0.49 to 0.82).ConclusionThe rates of sick leave in pregnancy vary greatly across European countries. Women using medications were more likely to be on sick leave, especially for acute illnesses. The differences in sick leave patterns across countries only partially reflected differences in sick leave policies, which implies that sick leave in pregnancy is also affected by other national differences.

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