A before and after, cross-sectional survey to evaluate the effectiveness of risk minimisation measures to minimise the risk of hospital-acquired hyponatraemia

Study identification

• EU PAS number:
  EUPAS38732
• Study ID:
  38733
• Official title and acronym:
  A before and after, cross-sectional survey to evaluate the effectiveness of risk minimisation measures to minimise the risk of hospital-acquired hyponatraemia
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  In July 2017, the European Pharmacovigilance Risk Assessment Committee concluded that there is an increased risk of hospital-acquired hyponatraemia associated with the administration of hypotonic intravenous fluids containing electrolytes and/or carbohydrates. Besides updating the product information, it was decided that further risk minimisation measures should be initiated at the national level. The Danish Medicines Agency and the Danish Patient Safety Authority Agency decided to distribute a treatment guide in June 2020 with basic information on treatment and prevention of hyponatraemia to all physicians working at emergency departments in Denmark. The primary objective of this study was to evaluate the effectiveness of the treatment guide implemented as part risk minimisation measures to reduce the risk of hospital-acquired hyponatraemia by assessing prescribing practice before and after the introduction of the treatment guide.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Data Analytic Center (DAC), Danish Medicine Agency

Denmark

Study timelines

Date when funding contract was signed

Planned:04/09/2018

Actual:04/09/2018

Study start date

Planned:01/03/2019

Actual:01/03/2019

Date of final study report

Planned:01/12/2021

Sources of funding

Other

More details on funding

Danish Medicines Agency

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable