Incidence and outcome of paracetamol poisoning

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17369
• EU PAS number:
  EUPAS6420
• Study ID:
  17369
• Official title and acronym:
  Incidence and outcome of paracetamol poisoning
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  During the past few years there has been a rapid increase in the number of exposure calls to the Swedish national poison center regarding paracetamol poisoning. The number of calls is probably an underestimation of the true incidence of this type of poisoning. The national hospital discharge registry is considered to have questionable reliability for estimation of incidence of this type of poisoning due to a large and increasing proportion of poisonings given an entirely unspecific ICD-10 code (T51.9 without ATC-code).The aim of the planned study is to collect individual data on actual levels of S-Paracetamol from hospital laboratories nation-wide. Cases will be defined by the S-paracetamol level, thus circumventing the problem with unspecific hospital discharge coding of poisonings. Based on this case definition information will be linked from the Swedish hospital discharge registry, Cause of death registry, and the Swedish prescribed drug register to target the following main goals:• Estimate annual incidence and change over time during the last 10 years.• By time series analysis evaluate possible effects of previous regulatory interventions, e.g. when sales of paracetamol was allowed outside pharmacies.• Describe outcome of this type of poisoning.• Estimate reliability of incidence based on data sources such as frequency of exposure calls to poison center.• Develop and validate indicators and time series analyses based on such data to be able to evaluate effects of future regulatory action.
• Study status:
  Finalised

Research institutions and networks

Institutions

Medical Products Agency

Study timelines

Date when funding contract was signed

Actual: 01/01/2014

Study start date

Planned: 05/05/2014

Actual: 09/05/2014

Data analysis start date

Planned: 01/09/2014

Actual: 03/11/2014

Date of final study report

Planned: 15/12/2014

Actual: 16/01/2017

Sources of funding

Other

More details on funding

Medical Products Agency

Regulatory

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