Paracetamol Pack Size Research Articles

Availability of Paracetamol Sold Over the Counter in Europe: A Descriptive Cross-Sectional International Survey of Pack Size Restriction.

Due to the risk of hepatotoxicity when excessive amounts of paracetamol are consumed, Poisons Information Centers (PICs) frequently receive paracetamol-related enquiries. This study examined how widely pack size restrictions of paracetamol sold over the counter have been implemented in Europe and also availability of paracetamol through non-pharmacy outlets and their possible associations with frequency of poisoning enquiries. A cross-sectional European multi-centre questionnaire study was performed using a questionnaire to identify the extent and nature of paracetamol pack size restrictions, non-pharmacy outlet sales and the frequency of paracetamol-related enquiries to PICs. In total, 21 European countries participated. All PICs provided telephone hotline services. In 14 (67%) countries, pack size restrictions had been implemented in pharmacies (range: 8-30g). No significant difference (median difference 0.7%, p-value=0.36) was found when comparing median frequencies of paracetamol-related enquiries in countries with pack size restriction to countries without restrictions. A significantly lower median frequency of paracetamol-related enquiries was found in countries without non-pharmacy outlet sales compared to those with such sales (median difference 2.2%, p=0.02). Pack size restrictions on pharmacy sales of paracetamol have been implemented in two-thirds of examined countries. There was no difference in the proportion of paracetamol-related enquiries to PICs among countries with and without pack size restrictions. However, a lower rate of paracetamol-related enquiries was noted in countries where paracetamol was not available in non-pharmacy outlets.

Size matters: effects of reduced paracetamol pack sizes in England and Wales

Size matters: effects of reduced paracetamol pack sizes in England and Wales

Impact of different pack sizes of paracetamol in the United Kingdom and Ireland on intentional overdoses: a comparative study

BackgroundIn order to reduce fatal self-poisoning legislation was introduced in the UK in 1998 to restrict pack sizes of paracetamol sold in pharmacies (maximum 32 tablets) and non-pharmacy outlets (maximum 16 tablets), and in Ireland in 2001, but with smaller maximum pack sizes (24 and 12 tablets). Our aim was to determine whether this resulted in smaller overdoses of paracetamol in Ireland compared with the UK.MethodsWe used data on general hospital presentations for non-fatal self-harm for 2002 - 2007 from the Multicentre Study of Self-harm in England (six hospitals), and from the National Registry of Deliberate Self-harm in Ireland. We compared sizes of overdoses of paracetamol in the two settings.ResultsThere were clear peaks in numbers of non-fatal overdoses, associated with maximum pack sizes of paracetamol in pharmacy and non-pharmacy outlets in both England and Ireland. Significantly more pack equivalents (based on maximum non-pharmacy pack sizes) were used in overdoses in Ireland (mean 2.63, 95% CI 2.57-2.69) compared with England (2.07, 95% CI 2.03-2.10). The overall size of overdoses did not differ significantly between England (median 22, interquartile range (IQR) 15-32) and Ireland (median 24, IQR 12-36).ConclusionsThe difference in paracetamol pack size legislation between England and Ireland does not appear to have resulted in a major difference in sizes of overdoses. This is because more pack equivalents are taken in overdoses in Ireland, possibly reflecting differing enforcement of sales advice. Differences in access to clinical services may also be relevant.

Paracetamol (acetaminophen) pack size restrictions and poisoning severity: time trends in enquiries to a UK poisons centre

In September 1998, legislation was introduced in the United Kingdom to limit paracetamol pack sizes to 16 tablets of 500 mg at general sales outlets and 32 tablets of 500 mg at pharmacies. The effect of the regulations on severity of paracetamol poisoning is unclear. The aim of this study was to describe trends in the severity of paracetamol poisoning and to assess the impact of the 1998 Regulations on the enquiries to a UK poisons centre. We extracted data about the age, sex and number of tablets or capsules of paracetamol ingested by patients notified to Guy's and St Thomas' Poisons Unit (London, UK) between 1996 and 2004. During the study period, there were approximately 140 000 patients with suspected paracetamol poisoning, accounting for around 11% of all patients reported to the poisons unit. The median number of tablets fell from 25 to 20 for males and 20 to 16 for females after 1998. There was also a reduction in the proportion of patients who ingested 17-32 tablets (from 36% to 30%) and 33-100 tablets (from 25% to 19%). Following the 1998 Regulations there was a decline in the severity, but not frequency, of paracetamol poisoning cases reported to Guy's and St Thomas' Poisons Unit. It is unclear whether the decline in severity was a direct consequence of the regulations.

Impact of Restricting Paracetamol Pack Sizes on Paracetamol Poisoning in the United Kingdom

Paracetamol (acetaminophen) is the most common drug taken in overdose in the UK, accounting for 48% of poisoning admissions to hospital and being involved in an estimated 100-200 deaths per year. In 1998, the UK government introduced legislation that reduced the maximum pack size of all non-effervescent tablets and capsules containing aspirin (acetylsalicylic acid) or paracetamol that can be sold or supplied from outlets other than registered pharmacies from 25 to 16 tablets or capsules. This article reviews the literature to determine the effectiveness of the legislation, focusing specifically on paracetamol poisoning. Seventeen studies on this subject were identified. Three studies found reductions in mortality rates; one study found an increase in mortality rates, while one found an initial reduction followed by an eventual increase; three found no significant difference in mortality rates before and after introduction of the legislation. Five studies found reductions in admissions to liver units, three of these finding a reduction in liver transplantation rates; two further studies found no change in liver function tests and rates of paracetamol-induced acute liver injury or failure. Four studies found a sustained decrease in hospital admissions, while two found an initial decrease followed by an eventual increase. One study found a decline in admissions for paracetamol poisoning and an increase in admissions for non-paracetamol poisoning. Sales data are conflicting, with two studies finding no significant difference in paracetamol sales before and after the introduction of the legislation and one reporting a decline. The severity of overdose appears to have decreased since the maximum permitted packet size was reduced, with five studies reporting a reduction in the number of severe overdoses (measured by numbers of tablets ingested, serum paracetamol concentrations and usage of antidotes). Only two studies reported an increase in the number of severe overdoses.Paracetamol-associated mortality rates, admissions to liver units/liver transplants, hospital admissions and the severity of paracetamol overdose appear to have been decreasing since 1998. However, one study showed that the reductions in mortality and hospital admissions began in 1997; therefore, the contribution of the 1998 legislation to the observed changes is unclear. Most of the studies are based on short-term follow-up so it is difficult to draw any conclusions regarding long-term trends. Many of the studies were also restricted to relatively small areas of the UK; this, combined with a variety of outcome measures, makes it difficult to distinguish any conclusive trends. The studies also suffer from a lack of comparison and control groups. Some studies do not clearly differentiate between the paracetamol preparations covered by the legislation and those not. The limited number of studies to date, combined with a variety of outcome measures, make it difficult to determine with accuracy whether or not the legislation has been a success. More long-term studies are needed to fully assess the impact of the legislation.

How has legislation restricting paracetamol pack size affected patterns of deprivation related inequalities in self-harm in Scotland?

To describe how changes in legislation to control sales and thus restrict the general availability of paracetamol have affected deprivation-related inequalities in deliberate self-harm associated with the drug in Scotland. A descriptive analysis of routine death and hospital discharge data for the entire Scottish population between 1995 and 2002. Patients in Scotland admitted to hospital with a diagnosis of poisoning and deaths in Scotland due to poisoning 1995-2002. Changes in mortality and overdose rates by deprivation quintile, and case fatality rates due to poisoning involving paracetamol. Rates of overdose involving paracetamol, while much higher in disadvantaged quintiles, fell in each deprivation quintile following the 1998 legislation. They then returned to levels similar, or above those in the mid 1990s. All quintiles were affected to a similar extent with the relationship between them remaining constant over time. Case fatality rates were significantly higher in more disadvantaged quintiles. Marked inequalities exist in paracetamol related harm in Scotland. The most disadvantaged groups (both male and female) have higher overdose and death rates, as well as higher case fatality rates. Following the restrictions all social groups saw similar reductions in paracetamol related harm. This effect has been short-lived and rates have returned to pre-legislation levels. Legislation has not permanently affected overall use of paracetamol in overdose in Scotland or reduced the proportion of patients taking paracetamol as a component of the overdose in the longer term. An important public health policy has failed to achieve its objective and it is not clear why. We need a better understanding of why this measure had only short-term benefits if its full potential is to be achieved.

Paracetamol availability and recent changes in paracetamol poisoning: is the 1998 legislation limiting availability of paracetamol being followed?

Objective: To determine the degree of adherence to legislation introduced in 1998 restricting the availability of over the counter paracetamol. Design: A prospective observational study. Setting: An emergency department in...

Impact of paracetamol pack size restrictions on poisoning from paracetamol in England and Wales: an observational study

About 500 drug poisoning deaths involving paracetamol (acetaminophen) occur every year in England and Wales. To reduce the number of deaths, regulations were introduced in 1998 to restrict the sale of paracetamol. In this paper, we evaluate the impact of these regulations. Mortality data for England and Wales were provided by the Office for National Statistics. Deaths were defined as due to compound paracetamol (paracetamol in combination with another analgesic, a low dose opioid or other ingredients) or paracetamol only, with or without alcohol or other drugs. The Department of Health provided data on all hospital admissions with a primary diagnosis of paracetamol poisoning. Mortality rates for paracetamol only were similar for males and females, and decreased from about 4.5 to 2.8 per million between 1997 and 1999 and again from about 3.1 to 2.2 per million between 2001 and 2002. These falls may be attributable to random variation in the rates. Deaths involving compound paracetamol, which were not subject to the 1998 regulations, remained relatively constant over the study period. There was evidence of a decreasing trend in paracetamol only mortality rates and this followed overall trends for other drug poisoning excluding opioids and drugs of misuse. Hospital admissions due to paracetamol poisoning increased from about 27 000 to 33 000 between 1995/1996 and 1997/1998 and then decreased to 25 000 in 2001/2002. There were almost 50 per cent more admissions for females than males, with the highest admission rates amongst females aged 15-24 years old. Between 1993 and 2002, mortality rates and hospital admissions due to paracetamol poisoning declined. However, the contribution of the 1998 regulations to this decline is not clear. Paracetamol poisoning continues to be an important public health issue in England and Wales and represents significant workload for the NHS in England.

Changes in paracetamol, antidepressants and opioid poisoning in Scotland during the 1990s.

Overdose is one of the commonest causes of medical admissions to UK hospitals. In Scotland (pop. 5.1 million), all NHS hospital discharge data is uniquely linked to enable identification of individuals re-presenting with the same diagnosis. To examine trends in discharges for poisoning, in particular paracetamol, antidepressants and opioids from 1990-99. Retrospective analysis. Discharge data from the Scottish Morbidity Record (SMR01) and mortality data from the General Register Office for Scotland (GROS) were analysed for 1990-99 by age and gender for the relevant codes. Overall discharge rates increased until 1997, after which they fell. This pattern was seen in paracetamol-related discharges, but not for antidepressants or for opioids. Overdose was more common in females, except for opioids. Discharges related to opioids increased in an exponential manner over the decade, five-fold in women and six-fold in men in 10 years. Increases in opioid-related presentations are of major concern. Changes in paracetamol pack-size have been associated with reduced discharge rates. In Scotland the age group with the highest rate of discharge (15-24 years) with paracetamol overdose is not the one with the highest mortality.

Paracetamol-related deaths in Scotland, 1994-2000.

To investigate the death rate due to paracetamol poisoning in Scotland and what effect the reduction in over-the-counter paracetamol pack sizes in 1998 had on the death rate. Records from 1994 to 2000 were examined to identify the number and annual incidence of paracetamol-related deaths. Numbers of deaths before and after the pack size reduction were compared. No significant differences were shown due to the pack size reduction. The Scottish paracetamol-related death rate was twice as high as in England and Wales. Further measures to reduce paracetamol-related morbidity and mortality in Scotland should be considered.

Paracetamol pack size restriction: the impact on paracetamol poisoning and the over‐the‐counter supply of paracetamol, aspirin and ibuprofen

Self-poisoning occurs with over-the-counter (OTC) drugs, particularly paracetamol (acetaminophen). In 1998, OTC pack sizes of paracetamol were reduced. We have studied the effect of this pack size restriction on OTC supply of paracetamol, aspirin and ibuprofen. IMS Health UK provided data on the UK sales of paracetamol, aspirin and ibuprofen. The total mass and number of packs of each drug supplied were compared for the years 1998, 1999 and 2000. The mass of aspirin and paracetamol sold fell, that of ibuprofen increased. The number of paracetamol packs sold was unchanged, the analgesic dose of aspirin fell and ibuprofen supply increased. It seems that the paracetamol pack size reduction has not achieved as large an overdose rate reduction as might have been expected. Instead, a shift to the use of ibuprofen may lead to an increase in gastrointestinal adverse events and continue the burden on healthcare resources.