Our study shows that legislation limiting OTC availability of paracetamol is not being followed in south London, and furthermore that many patients still have a potentially toxic supply of paracetamol at home. Half of patients who ingested greater than 16 tablets used stocks at home. Our study shows that 80% of non‐pharmacy outlets in south London that were surveyed sold paracetamol in a manner contravening the 1998 legislation.
Although the total number of patients who ingested a potentially toxic amount of paracetamol and who had purchased the tablets for the purpose of taking the overdose is small (35), nearly half (16) of these patients purchased the tablets in a manner contravening the 1998 legislation. This finding suggests that enforcement of the legislation may help to reduce the severity of paracetamol poisoning. The methods used to obtain paracetamol tablets (that is, if the tablets were purchased in a manner contravening the legislation) by the 72 patients who did not purchase a toxic amount of paracetamol for the purpose of taking an overdose were not recorded.
Although strict enforcement of the legislation would have only reduced the total number of overdoses by 15% in this study, one of the indirect aims of the legislation was to decrease the severity of poisoning and this would have been achieved in 21% (16 of 77) of potentially toxic overdoses.
This is a small study, examining a discrete community in south London. Our findings may not be reflective of nationwide practice in regards to the 1998 legislation. The numbers of outlets in our study is too small to enable analysis by type of outlet and therefore the overall conclusions cannot be generalised to particular types of outlet. There is potential for bias and inaccuracy when patients provide information regarding methods used to obtain paracetamol tablets. This small study needs to be repeated on a larger scale before nationwide conclusions can be made.
Although studies have examined the impact of 1998 legislation limiting the OTC availability of paracetamol,2,10,11
a recent review article highlights the limitations and conflicting findings of currently published studies, and concludes that although the 1998 legislation seems to have been associated with reduced paracetamol related morbidity, further research is needed to fully evaluate the impact of the legislation.11,12
Attributing the legislation as the primary cause of any apparent changes in paracetamol overdose related morbidity requires evidence that the legislation is achieving its primary goal—to reduce the availability of paracetamol stores in the home at any one time and hence the amount of paracetamol available to be ingested in overdose.5
Sales data show that although pack sizes of paracetamol decreased from an average of 35 tablets (1996–7) to 24 tablets (1998–9), the total number of tablets sold increased from 520 million (1996–7) to 580 million (2001–2).10
Total sales of compound analgesic tablets containing paracetamol also increased.10
These findings cannot be explained by an increase in the UK population (population growth averaged 0.3% per year 1991–200315
). These figures do not support the assumption that the 1998 legislation has lead to a decrease in the amount of paracetamol stored in the average UK home available for short term ingestion. The legislation may have reduced the peak availability in terms of number of tablets available in the home at any one time for a single ingestion; however there are currently no published data available illustrating this. Half of our study population who ingested a potentially toxic dose of paracetamol did so by using stocks stored at home.
- Legislation introduced in 1998 restricting the availability of OTC paracetamol is not being adhered to in south London.
- Further studies are needed to determine the degree of nationwide adherence to this legislation.
- The legislation may not be achieving the goal of reducing stores of paracetamol in the community available for overdose.
Other studies have illustrated poor adherence to guidelines or legislation limiting the availability of paracetamol in the community. A study in Ireland showed poor compliance among non‐pharmacy outlets with guidelines limiting paracetamol sales at a time when hospital admissions for paracetamol overdose were increasing.16
A 2001 study in London showed poor compliance with the new legislation in pharmacies, supermarkets, and corner stores.17
Gunnell et al
found that compared with England and Wales paracetamol related morbidity and mortality were less in France where the quantity of paracetamol in a single purchase is limited, suggesting a link between paracetamol availability in the community and paracetamol related morbidity and mortality.18
Currently there is no published evidence showing that the 1998 legislation has reduced the total mass of paracetamol available in household stocks to be ingested in overdose, and our study shows that, in south London at least, there is poor adherence with the legislation. Further research is needed to determine the degree of adherence to the 1998 legislation throughout the UK and to assess whether any observed changes in paracetamol poisoning are attributable to the legislation itself or other factors. If other studies confirm poor adherence, measures must be introduced to enforce the legislation.