Läkemedelsverkets Farmakovigilansdag 19 maj 2015

Storlek: px

Starta visningen från sidan:

Download "Läkemedelsverkets Farmakovigilansdag 19 maj 2015"

Jan-Erik Fredriksson
för 7 år sedan
Visningar:

1 Läkemedelsverkets Farmakovigilansdag 19 maj 2015 Incidence and outcome of paracetamol poisoning Rolf Gedeborg Associate Professor, Scientific Director of Epidemiology and Pharmacovigilance Unit for Scientific Support Paracetamol First used clinically in 1893 Did not appear commercially until 1950 in the United States First approval in Sweden in 1955 Very favorable safety profile Discovery in 1966 that a major overdose could cause severe and sometimes fatal liver damage Early treatment with N-acetylcysteine prevents liver toxicity Substantial increase in use in the 1980s when aspirin was linked to Reye's syndrome First-choice over-the-counter treatment for analgesia and antipyresis in children Observera att bilderna är presentatörens tolkning och avspeglar den information som fanns tillgänglig vid presentationstillfället 1

3 Läkemedelsverkets Farmakovigilansdag 19 maj 2015 Study rationale and objectives Estimate annual incidence and change over time. With 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 estimates 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. Summary incidence trend The incidence of paracetamol poisoning has increased with 103% during the 14-year study period, to a level of 16.2 per population in This corresponds to a total of paracetamol poisoning events in Sweden in Following the regulatory intervention in November 2009, when sales of paracetamol was allowed in non-pharmacy outlets, incidence has increased with 40%. Also after adjustment for overall time trends in sales volume of paracetamol, suicide rates, and hospital admission for selfharm, the change in trend appears unlikely to be caused by random variation. Observera att bilderna är presentatörens tolkning och avspeglar den information som fanns tillgänglig vid presentationstillfället 3

4 Läkemedelsverkets Farmakovigilansdag 19 maj 2015 Summary case baseline characteristics The majority of poisoning events (85%) are classified as intentional self-harm. The median age was 28 years and 76.7 % were female. Among cases of intentional self-harm 41% are in the age category years. 8.4 % of the cases were prescribed paracetamol during the 7-day period, 18.1 % during the 30-day period, and 37.9 % during the year preceding the poisoning event % had a alcohol related hospital discharge diagnosis recorded during the 5-year period preceding the poisoning event. Summary incidence indicator Incidence estimation based solely on hospital discharge diagnoses and cause of death data correlated well (r = 0.94) with, but underestimated, the primary case definition of the study. Frequency of poison center exposure calls also correlated with the study case definition but not to the same extent (r = 0.76). Observera att bilderna är presentatörens tolkning och avspeglar den information som fanns tillgänglig vid presentationstillfället 4

10 Läkemedelsverkets Farmakovigilansdag 19 maj 2015 Summary A signal of a rapidly increasing number of exposure calls to the Swedish PIC Possible to collect near national coverage of biomarker Temporally associated with the November 2009 decision to allow marketing of paracetamol in non-pharmacy outlets, there was a 40% increase in the incidence of paracetamol poisoning 85% self-harm Availability of importance to self-harm Previous studies Temporal association with increased availability Regulatory action Maximise effect on self-harm Minimise effect on normal usage Åtgärd Läkemedelsverket beslutat att receptfria tabletter med paracetamol inte längre ska få säljas på andra försäljningsställen än apotek efter den 1 november Förslaget berör endast tabletter med paracetamol avsedda att sväljas hela. Paracetamol i till exempel flytande form och brustabletter berörs inte utan kommer fortfarande att kunna finnas tillgängliga i dagligvaruhandeln. Observera att bilderna är presentatörens tolkning och avspeglar den information som fanns tillgänglig vid presentationstillfället 10

11 Läkemedelsverkets Farmakovigilansdag 19 maj 2015 Acknowledgement The study depended on the work and cooperation of health care professionals and administrators that provided high-quality individual patient data on serum paracetamol levels from the following Swedish county councils and regions: Blekinge County Council, Dalarna County Council, Gävleborg County Council, Jämtland County Council, Jönköping County Council, Kalmar County Council, Kronoberg County Council, Norrbotten County Council, Region Gotland, Region Halland, Region Skåne, Region Västra Götaland, Stockholm County Council, Sörmland County Council, Uppsala County Council, Värmland County Council, Västernorrland County Council, Västmanland County Council, Örebro County Council, and Östergötland County Council. Observera att bilderna är presentatörens tolkning och avspeglar den information som fanns tillgänglig vid presentationstillfället 11

Relevanta dokument

har du råd med höjd bensinskatt? har du råd med höjd bensinskatt?

har du råd med höjd bensinskatt? har du råd med höjd bensinskatt? 82 535 000 kronor dyrare med bensin för invånarna här i Blekinge län. 82 535 000 kronor dyrare med bensin för invånarna här i Blekinge län. 82 535 000 kronor dyrare med bensin för invånarna här i Blekinge