Does the EU's Paediatric Regulation work for new medicines for children in Denmark, Finland, Norway and Sweden? A cross-sectional study.

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.

An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions.

Introduction: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority.

Gamma-hydroxybutyrate and cocaine intoxication in a Danish child.

GHB intoxication must be considered in children with coma and a suspicion of drug intoxication. Furthermore, mixed intoxication with several substances and the possibility of unpredictable symptom profiles should be anticipated to ensure optimal symptomatic treatment of patients.

Cholecystectomy for the elderly: no hesitation for otherwise healthy patients.

Background: The number of Danish inhabitants older than 65 years is increasing, and cholecystectomy is one of the most common surgical procedures performed for this age group. This study aimed to analyze the role of age as an independent predictor of outcome for elderly cholecystectomy patients.

Methods: Data from the Danish Cholecystectomy Database (2006-2010) were used.

[Neurological symptoms following infusion of infliximab].

Infliximab is indicated for treatment of plaque psoriasis when traditional systemic therapy is inadequate or inappropriate. The treatment is efficient but also carries a risk of serious adverse drug events. We describe a case of neurological symptoms following the first infusion of infliximab in a patient treated for plaque psoriasis.

Nationwide quality improvement of cholecystectomy: results from a national database.

Objective: To evaluate whether quality improvements in the performance of cholecystectomy have been achieved in Denmark since 2006, after revision of the Danish National Guidelines for treatment of gallstones.

Design: A national database that monitors the quality of cholecystectomy was established, and registration of all cholecystectomies in Denmark was mandatory since 1 January 2006. Indicators describing the operation, the postoperative course, the surgical outcome and various risk factors were followed for 4 years.

The quality of cholecystectomy in Denmark: outcome and risk factors for 20,307 patients from the national database.

Background: Laparoscopic cholecystectomy is the standard treatment for symptomatic gallstones. The quality of the procedure frequently is included in quality improvement programs, but outcome values have not been described to define the standard of care for a general population. This study included 20,307 cholecystectomies from a national prospective database that combines administrative data with clinical data.

Sex differences in laparoscopic cholecystectomy.

Background: Conversion from laparoscopic to open cholecystectomy may not be desirable due to the increased complication rate and prolonged convalescence. In Denmark, nationwide data show that 7.7% of the laparoscopic cholecystectomies are converted to open surgery.

Validation of data and indicators in the Danish Cholecystectomy Database.

Objective: In The Danish Cholecystectomy Database (DCD), quality indicators are derived from clinical data in combination with administrative data from the National Patient Registry. The indicators 'Length of postoperative stay < or =1 day and no readmission', 'Length of stay (LOS) >3 days and/or readmission', 'Additional procedures within 30 days', 'Reconstructive bile duct surgery', 'Other surgery of the bile duct' and 'Death within 30 days' are all derived from administrative data. This study investigates the validity of the administrative data and evaluates the association between these indicators and postoperative complications.