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      Long term effect of reduced pack sizes of paracetamol on poisoning deaths and liver transplant activity in England and Wales: interrupted time series analyses


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          Objective To assess the long term effect of United Kingdom legislation introduced in September 1998 to restrict pack sizes of paracetamol on deaths from paracetamol poisoning and liver unit activity.

          Design Interrupted time series analyses to assess mean quarterly changes from October 1998 to the end of 2009 relative to projected deaths without the legislation based on pre-legislation trends.

          Setting Mortality (1993-2009) and liver unit activity (1995-2009) in England and Wales, using information from the Office for National Statistics and NHS Blood and Transplant, respectively.

          Participants Residents of England and Wales.

          Main outcome measures Suicide, deaths of undetermined intent, and accidental poisoning deaths involving single drug ingestion of paracetamol and paracetamol compounds in people aged 10 years and over, and liver unit registrations and transplantations for paracetamol induced hepatotoxicity.

          Results Compared with the pre-legislation level, following the legislation there was an estimated average reduction of 17 (95% confidence interval −25 to −9) deaths per quarter in England and Wales involving paracetamol alone (with or without alcohol) that received suicide or undetermined verdicts. This decrease represented a 43% reduction or an estimated 765 fewer deaths over the 11¼ years after the legislation. A similar effect was found when accidental poisoning deaths were included, and when a conservative method of analysis was used. This decrease was largely unaltered after controlling for a non-significant reduction in deaths involving other methods of poisoning and also suicides by all methods. There was a 61% reduction in registrations for liver transplantation for paracetamol induced hepatotoxicity (−11 (−20 to −1) registrations per quarter). But no reduction was seen in actual transplantations (−3 (−12 to 6)), nor in registrations after a conservative method of analysis was used.

          Conclusions UK legislation to reduce pack sizes of paracetamol was followed by significant reductions in deaths due to paracetamol overdose, with some indication of fewer registrations for transplantation at liver units during the 11 years after the legislation. The continuing toll of deaths suggests, however, that further preventive measures should be sought.

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          Most cited references25

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          Interrupted time series designs in health technology assessment: lessons from two systematic reviews of behavior change strategies.

          In an interrupted time series (ITS) design, data are collected at multiple instances over time before and after an intervention to detect whether the intervention has an effect significantly greater than the underlying secular trend. We critically reviewed the methodological quality of ITS designs using studies included in two systematic reviews (a review of mass media interventions and a review of guideline dissemination and implementation strategies). Quality criteria were developed, and data were abstracted from each study. If the primary study analyzed the ITS design inappropriately, we reanalyzed the results by using time series regression. Twenty mass media studies and thirty-eight guideline studies were included. A total of 66% of ITS studies did not rule out the threat that another event could have occurred at the point of intervention. Thirty-three studies were reanalyzed, of which eight had significant preintervention trends. All of the studies were considered "effective" in the original report, but approximately half of the reanalyzed studies showed no statistically significant differences. We demonstrated that ITS designs are often analyzed inappropriately, underpowered, and poorly reported in implementation research. We have illustrated a framework for appraising ITS designs, and more widespread adoption of this framework would strengthen reviews that use ITS designs.
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            Open verdict v. suicide - importance to research.

            Open verdicts are often included in with suicides for research purposes and for setting health targets. To examine similarities and differences in cases defined by the coroner as suicide and open verdicts and the implications of open verdicts for suicide research. All cases of open and suicide verdicts recorded in the Newcastle Coroner's Court in the period 1985-1994 were compared on demographic and medical parameters. Open and suicide verdicts had many similarities, differing only in some respects, of which logistic regression identified the most significant to be a suicide note, method used and age. Open verdicts should be included in all suicide research after excluding cases in which suicide was unlikely. Objective criteria are needed to facilitate comparison between different studies.
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              UK legislation on analgesic packs: before and after study of long term effect on poisonings.

              To evaluate the long term effect of legislation limiting the size of packs of analgesics sold over the counter. Before and after study. Suicides in England and Wales, data from six liver units in England and Scotland and five general hospitals in England, and UK data on sales of analgesics, between September 1993 and September 2002. Office for National Statistics; six liver units in England and Scotland; monitoring systems in general hospitals in Oxford, Manchester, and Derby; and Intercontinental Medical Statistics Health UK. Deaths by suicidal overdose with paracetamol, salicylates, or ibuprofen; numbers of patients admitted to liver units, listed for liver transplant, and undergoing transplantations for paracetamol induced hepatotoxicity; non-fatal self poisonings with analgesics and numbers of tablets taken; and sales figures for analgesics. Suicidal deaths from paracetamol and salicylates were reduced by 22% (95% confidence interval 11% to 32%) in the year after the change in legislation on 16 September 1998, and this reduction persisted in the next two years. Liver unit admissions and liver transplants for paracetamol induced hepatotoxicity were reduced by around 30% in the four years after the legislation. Numbers of paracetamol and salicylate tablets in non-fatal overdoses were reduced in the three years after the legislation. Large overdoses were reduced by 20% (9% to 29%) for paracetamol and by 39% (14% to 57%) for salicylates in the second and third years after the legislation. Ibuprofen overdoses increased after the legislation, but with little or no effect on deaths. Legislation restricting pack sizes of analgesics in the United Kingdom has been beneficial. A further reduction in pack sizes could prevent more deaths.

                Author and article information

                Role: professor of psychiatry and director centre for suicide research
                Role: researcher
                Role: researcher
                Role: scientific assessor
                Role: principal statistician
                Role: reader in hepatology
                Role: professor of epidemiology
                Role: professor of psychiatry and population health
                BMJ : British Medical Journal
                BMJ Publishing Group Ltd.
                7 February 2013
                : 346
                : f403
                [1 ]University of Oxford Centre for Suicide Research, Department of Psychiatry, Warneford Hospital, Headington, Oxford OX3 7JX, UK
                [2 ]Post Authorisation Signal Unit, Vigilance and Risk Management of Medicines, Medicines and Healthcare products Regulatory Agency, London, UK
                [3 ]Statistics and Clinical Audit, NHS Blood and Transplant, Stoke Gifford, Bristol, UK
                [4 ]Liver Intensive Therapy Unit, Institute of Liver Studies, King’s College Hospital, London, UK
                [5 ]University of Bristol, School of Social and Community Medicine, Canynge Hall, Bristol UK
                [6 ]University of Manchester, Centre for Suicide Prevention, University Place, Manchester, UK
                Author notes
                Correspondence to: K Hawton keith.hawton@ 123456psych.ox.ac.uk
                © Hawton et al 2013

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

                : 11 December 2012



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