J H C Inglis
NHS Health Scotland, Woodburn House, Canaan Lane, Edinburgh
Correspondence to: Dr James Inglis, Consultant in Public Health, Medicine/Director of Health Information, NHS Health Scotland, Woodburn, House, Canaan Lane, Edinburgh, EH10 4HG Tel: 44 (0)131 536 5500
Email: jamie.inglis@hebs.scot.nhs.uk
SMJ 2004 49(4): 142-143
Objective: To identify any effect on deaths and emergency admissions for poisoning resulting from the restriction on paracetamol sales introduced in September 1998. Setting: Scotland Data: Deaths from poisoning were extracted from the General Registrar (Scotland) Office annual reports for 1991 to 2001 and emergency admissions data for 1990/91 to 2001/02 was supplied by the Information and Statistics Division of NHS Scotland. Results: Deaths In the early 1990s, deaths from all poisonings and deaths from paracetamol poisoning were stable. After the restrictions deaths from all poisonings remained stable. Deaths from paracetamol poisoning fell by 45% in 1998 but have risen in each of the three years since to reach pre-restriction levels. Results : Emergency admissions In the early 1990s all poisonings rose steadily. Following the restrictions all admissions fell by 10% and paracetamol poisonings fell by 14%. All admissions remained lower for a further two years but are now rising again. Paracetamol poisonings remained lower for a second year but the last two years have both seen 10% increases to reach record levels. Discussion: The restrictions caused a dramatic 45% fall in deaths from paracetamol poisoning and reversed a relentless upward rise in all admissions for poisoning. The benefits were short-lived lasting about two years. Deaths and admissions are rising again and admissions are at record levels. Conclusions: Restricting paracetamol sales resulted in significant health gain. Further restrictions and public education on this valuable but dangerous drug are both urgently needed.
Keywords: Paracetamol, poisoning, deaths, emergency admissions, Scotland public health, legislation.
Paracetamol is one of the most widely used of all drugs. With a population of 5.1 million people, Scotland consumed an estimated 300 million tablets containing paracetamol in 2001.1 Paracetamol overdose is the most common method of deliberate self-harm in the UK and is implicated in 40% of cases.2 Poisoning, both intentional and unintentional, with paracetamol became a significant public health issue throughout the 1970s and an epidemic of paracetamol related suicide in the UK in the 1980s and into the 1990s eventually developed.3 Population based measures to control paracetamol poisoning were needed and, as a result, on 16th September 1998 regulations came into force restricting the sale of paracetamol (and aspirin) tablets to 16 tablets per person per purchase from retail outlets and 32 tablets per sale from pharmacies.4 The packaging was changed from a loose preparation to a blister pack and this additional measure resulted in an almost doubling of the price per tablet of both paracetamol and aspirin. Regulations for the control of paracetamol came into force in Ireland in October 2001.5 In the United States, the Food and Drug Administration (FDA) has decided not to introduce restrictions on paracetamol sales.6
Data
Deaths data for all poisonings and those attributed to paracetamol were extracted from the General Registrar (Scotland) Office (GR(S)O) Annual Reports for the years 1991 to 2001. (The codings used include ICD9, E950 plus E980; and ICD10, X-60 to 64). Admissions data for the years 1990/91 to 2001/02 was provided by the Information and Statistics Division of the Common Services Agency, NHS Scotland. The data was extracted from the SMR01 file and covers all emergency admissions for poisoning.
Deaths
Deaths from poisoning in Scotland 1991-2001 [figure 1] Between 1991 and 1997 all deaths from poisoning range from 250 to 300 deaths per year and remained essentially stable. In the same period deaths from paracetamol poisoning ranged from 36 to 48 deaths per year and also appeared relatively stable. In 1998 there was a small decline in all deaths and a 45% fall to 22 paracetamol deaths. All deaths from poisonings remained stable in 1999 and 2000, but 2001 saw a 23% rise to stand again at just under 300 deaths that year. Deaths from paracetamol poisoning have climbed in each of the three years since their 1998 low, reaching 38 deaths in 2001.
Emergency admissions
Emergency admissions for poisoning in Scotland 1990/ 91-2001/02 (Fig 2) (Note: The admissions data covers financial years. Consequently 97/98 was not affected, 98/ 99 was affected for six months and 99/00 was the first year fully affected by the restrictions.) A steady and sustained increase in the total number of poisonings in Scotland can be seen rising from 13,613 in 1990/91 to 20,127 in 1997/98, an increase of 48%. A similar picture is evident for paracetamol poisonings increasing at a faster rate from 3,605 admissions in 1990/ 91 to a peak of 6,782 admissions in 1997/98, an increase of 88%.
In 1998/99, the first year partially affected by the restrictions a reversal of the trend in both total poisonings and poisonings by paracetamol occurred with a fall of 10% in total poisonings and a 14% fall in paracetamol poisonings. The reduction in all admissions and paracetamol poisoning lasted for a second year but emergency admissions for paracetamol poisoning rose by 10% in 2000/01 and recorded a further 10 increase in 2001/02 to reach their present peak of 6,984 admissions. All admissions for poisoning remained lower for a third year but have since begun to rise and have almost returned to their 1997/98 peak. Admissions for paracetamol overdose now make up 36.3% of all admissions compared with 26.5% in 1991/92.
Restricting the number of paracetamol tablets that could be purchased at any one time caused a dramatic 45% reduction in deaths from paracetamol poisoning and reversed the upward trend in all emergency admissions for poisoning. This lasted for about two years. As many as 30 deaths may have been prevented and a large number of emergency admissions and concomitant morbidity avoided. Five years after the limited restriction on sales, irrespective of the impact of the current restrictions, significant harm is still being caused as a result of paracetamol poisoning.
Options
A number of population based strategies have been proposed including: adding methionine, which protects the liver, to each tablet; restricting sales still further to 12x500mg tablets as ingestion of 12g (24 tablets) or less is unlikely to cause serious harm7 ; making paracetamol a prescription only medicine (POM); making paracetamol a pharmacy only medicine; and further public education on the dangers of overdose.
Risks
The principal risk with any strategy to reduce paracetamol poisoning is forcing individuals intent on self-harm to switch to another even more dangerous medication. Similarly, any strategy focusing solely on paracetamol poisoning runs the risk of failing to address the societal influences which determine intentional self-harm. International comparisons suggest the United Kingdom has an entrenched mass awareness of paracetamol as a vehicle for suicide and that notion may be difficult to reverse.3 The case for methionine remains not proven as the risks are not well enough known8 9 . Further restrictions would cause inconvenience but 74% of paracetamol overdoses have premeditation of less than three hours and 41% of such patients had obtained tablets less than an hour before.10
Five years after the restriction on sales the upward momentum of the epidemic has returned and preventable deaths and avoidable emergency admissions are as high, or higher, than before the restrictions were introduced. Given the evidence that restrictions on sales achieve significant health gain, the Medicines and Healthcare products Regulatory Agency should impose further restrictions on sales. Public education campaigns on the dangers of paracetamol are also urgently needed to improve knowledge and reduce reliance on this valuable but dangerous drug.
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