Paracetamol Sales Research Articles

The impact of codeine rescheduling on non-opioid analgesic use by people who regularly use codeine: a prospective cohort study

BackgroundCodeine was rescheduled in Australia to prescription only in February 2018. Initial studies reported an increase in population level paracetamol and ibuprofen sales following codeine upscheduling. However, to date no study has been able to investigate changes in non-opioid analgesic use at the individual patient level to determine if sales data reflect actual consumption patterns.AimTo address this gap, we aimed to determine the impact of codeine rescheduling on non-opioid analgesic use in people who regularly used over-the-counter codeine, primarily for pain, prior to the rescheduling change.MethodWe conducted a prospective cohort study with 260 participants who reported regular over-the-counter codeine consumption at cohort entry. Surveys were completed at baseline (November 2017, 3 months before rescheduling) and at 1 month (February 2018), 4 months (June 2018), and 12 months (February 2019), following rescheduling. The primary outcomes were mean daily doses of non-opioid analgesics, captured through a 7 day medication diary.ResultsThe mean daily paracetamol dose decreased from 1754.4 mg (95% CI 1300.5–2208.3) at baseline to 1023.8 mg (95% CI 808.5–1239.1) at the final time-point (+ 12 months) (p = .009). The mean daily ibuprofen dose decreased from 305.1mg (95% CI 217.9–392.4) at baseline to 161.2 mg (95% CI 98.5–224.0) 12 months after rescheduling (p = .03). No significant change in doses of other medications remained was found.ConclusionIn people who regularly consumed over-the-counter codeine, doses of non-opioid analgesics either reduced or remained stable following codeine rescheduling, suggesting concerns of medication substitution or overuse following the change were not realised.

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.

Increased acetaminophen related calls to Finnish PIC better reflect acetaminophen sales than serious poisonings

Objective: Acetaminophen (APAP) or paracetamol is a commonly encountered medicine in poisonings. We studied the changes in APAP related calls to the Finnish poison information centre (FPIC), and serious intoxications, involving hepatotoxicity or death in 2001–2014. These data were compared with paracetamol sales in Finland.Methods: This is a retrospective analysis of the FPIC database calls, national cause of death registry, registries of liver transplantations and molecular adsorbent recycling system (MARS)-treated patients from Helsinki University Hospital together with the National Institute of Health and Welfare registry of patients hospitalized. Data on APAP sales were obtained from the Finnish Medicines Agency.Results: Between 2001 and 2014, the number of calls/year related to human APAP exposures to the FPIC increased from 227 to 1058. No change in the age distribution of enquiries was seen. Most calls involved minors: 58% (range 52–64%) for children under 6 years old, and 9% (range 6–14%) for children of 6–15 years. In Finland, APAP related fatalities have gradually increased from an average of 7/year (range 4–10) in 2000–2005 to an average of 11/year (range 6–17) in 2010–2013, whereas the number of liver transplantations remained low, average 0.6/year (range 0–2). For patients in need of MARS-treatment, a slight decrease was seen. Total APAP sales increased from 5.6 (47% prescription, 53% OTC) to 29.7 (81% prescription, 19% OTC). DDD/1000 inhabitants/day from 2001 to 2014 is recorded. Best linear relationship (R2 = 0.97; p < .001) was observed between total FPIC calls and total sales of APAP in 2001–2014. Fatalities show a weaker relationship with sales (R2 = 0.317; p = .045).Conclusions: During the study period, we see an increase in FPIC exposure calls accompanied by an increase in APAP sales. Changes in the chosen indicators for serious poisonings show only a weak association. Despite an evident trend between sales and fatalities, the correlation with fatality remains weak due to the small number of fatalities.

How well are national guidelines relating to the general sales of aspirin and paracetamol, adhered to by retail stores: a mystery shopper study

ObjectiveTo determine whether non-pharmaceutical retail outlets are aboding to the current Medicines and Healthcare products Regulatory Agency (MHRA) national guidelines for over-the-counter (OTC) sales of aspirin and paracetamol.MethodsStages 1 and...

Paracetamol as a toxic substance for children: aspects of legislation in selected countries.

Paracetamol is used widely in pediatrics because it has a high drug safety when used in therapeutic dosages. In case of overdose the majority of paracetamol is metabolized to N-acetyl-p-benzoquinone imine (NAPQI), which is responsible for the severe toxic effects. The covalent connection between NAPQI and hepatic proteins leads to hepatocellular damage and possibly to severe liver failure. The antidote for paracetamol is N-acetylcysteine (NAC). It is a precursor of glutathione and aids to fill glutathione stores. The Rumack-Matthew nomogram should be used to decide on antidote treatment. Pediatric drug metabolism differs from adult metabolism. Children have a larger liver size compared to their body weight than adults, resulting in a higher metabolism rate. Young children seem to be less sensitive to acute intoxication than adults. One hypothesis to explain the lower rate refers to the larger liver size. The acute toxic dosage for children is more than 200 mg/kg body weight. There seems to be a global increase in accidental pediatric paracetamol overdose. Governmental websites of various European Union (EU) countries were searched for legal information on paracetamol availability in pharmacies and non-pharmacy stores. Various EU countries permit prescription-free sales of paracetamol in pharmacies and non-pharmacy stores. In Sweden paracetamol 500 mg may be sold in both pharmacies and non-pharmacies in a maximum pack size of 20 units. In the United Kingdom (UK) paracetamol 500 mg is listed in the general sales list with a maximum pack size of 30 effervescent tablets or 16 tablets. In Ireland paracetamol 500 mg may be sold in a maximum pack size of 12 units in a non-pharmacy. In the Netherlands paracetamol 500 mg is legal to be sold in a maximum pack size of 50 units in a drug store and with a maximum of 20 units in any other non-pharmacy. Several countries in the European Union are permitted to offer paracetamol prescription-free in pharmacies and non-pharmacy stores without legal guidance on the storage position within the store. Further research is needed to investigate whether paracetamol is located directly accessible to young children within the stores in EU countries which permit prescription-free sales of paracetamol.

RPS calls for tighter legislation over paracetamol sales

RPS calls for tighter legislation over paracetamol sales

A one-year observational study of all hospitalized and fatal acute poisonings in Oslo: Epidemiology, intention and follow-up

BackgroundUp to date information on poisoning trends is important. This study reports the epidemiology of all hospitalized acute poisonings in Oslo, including mortality, follow-up referrals, and whether the introduction of over-the-counter sales of paracetamol outside pharmacies had an impact on the frequency of poisonings.MethodsAll acute poisonings of adults (≥16 years) treated at the five hospitals in Oslo from April 2008 to April 2009 were included consecutively in an observational cross-sectional multicentre study. A standardized form was completed by the treating physician, which covered the study aims. All deaths by poisoning in and outside hospitals were registered at the Institute of Forensic Medicine.ResultsThere were 1065 hospital admissions of 912 individuals; 460 (50%) were male, and the median age was 36 years. The annual incidence was 2.0 per 1000. The most frequent toxic agents were ethanol (18%), benzodiazepines (15%), paracetamol (11%), and opioids (11%). Physicians classified 46% as possible or definite suicide attempts, 37% as accidental overdoses with substances of abuse (AOSA), and 16% as other accidents. Twenty-four per cent were discharged without any follow-up and the no follow-up odds were highest for AOSA. There were 117 deaths (eight in hospital), of which 75% were males, and the median age was 41 years. Thus, the annual mortality rate was 25 per 100 000 and the in-hospital mortality was 0.8%. Opioids were the most frequent cause of death.ConclusionsThe incidence of hospitalized acute poisonings in Oslo was similar to that in 2003 and there was an equal sex distribution. Compared with a study performed in Oslo in 2003, there has been an increase in poisonings with a suicidal intention. The in-hospital mortality was low and nine out of ten deaths occurred outside hospitals. Opioids were the leading cause of death, so preventive measures should be encouraged among substance abusers. The number of poisonings caused by paracetamol remained unchanged after the introduction of over-the-counter sales outside pharmacies and there were no deaths, so over-the-counter sales may be considered safe.

Which population level environmental factors are associated with asthma, rhinoconjunctivitis and eczema? Review of the ecological analyses of ISAAC Phase One

The International Study of Asthma and Allergies in Childhood (ISAAC) Phase One showed large worldwide variations in the prevalence of symptoms of asthma, rhinoconjunctivitis and eczema, up to 10 to 20 fold between countries. Ecological analyses were undertaken with ISAAC Phase One data to explore factors that may have contributed to these variations, and are summarised and reviewed here.In ISAAC Phase One the prevalence of symptoms in the past 12 months of asthma, rhinoconjunctivitis and eczema were estimated from studies in 463,801 children aged 13 - 14 years in 155 centres in 56 countries, and in 257,800 children aged 6-7 years in 91 centres in 38 countries. Ecological analyses were undertaken between symptom prevalence and the following: Gross National Product per capita (GNP), food intake, immunisation rates, tuberculosis notifications, climatic factors, tobacco consumption, pollen, antibiotic sales, paracetamol sales, and outdoor air pollution.Symptom prevalence of all three conditions was positively associated with GNP, trans fatty acids, paracetamol, and women smoking, and inversely associated with food of plant origin, pollen, immunisations, tuberculosis notifications, air pollution, and men smoking. The magnitude of these associations was small, but consistent in direction between conditions. There were mixed associations of climate and antibiotic sales with symptom prevalence.The potential causality of these associations warrant further investigation. Factors which prevent the development of these conditions, or where there is an absence of a positive correlation at a population level may be as important from the policy viewpoint as a focus on the positive risk factors. Interventions based on small associations may have the potential for a large public health benefit.

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.

Restriction on paracetamol sales will not save lives

In reply to Geoffrey Brandon (letters November 1), about 18 years ago, when completing my training, I was ‘specialed’ to look after a 16-year-old girl who was very ill with a high temperature, diarrhoea and vomiting. The doctors had been unable to find an infection. Eventually her boyfriend told them she had taken eight paracetamol with a fizzy drink, having been told it would give the same effect as being drunk. Her condition deteriorated and she died.

Legislation restricting paracetamol sales and patterns of self‐harm and death from paracetamol‐containing preparations in Scotland

To describe how changes in legislation to restrict paracetamol sales have affected overdose discharges and death associated with the drug in Scotland. A descriptive analysis of routine death and hospital discharge data for the entire Scottish population between 1995 and 2004. Patients in Scotland participated who were discharged from hospital with a diagnosis of poisoning; deaths in Scotland from diagnosis of poisoning 1995-2003 were also analysed. Outcome measures were changes in mortality and overdose due to poisoning involving paracetamol. A comparison was made of in-hospital and out-of-hospital mortality in fatalities involving paracetamol. The majority of paracetamol-associated deaths were due to co-proxamol. Deaths associated with paracetamol alone or with ethanol occurred principally in hospital and were a minority of deaths overall. The proportion of in-hospital deaths attributed to paracetamol increased (post/pre ratio 1.347; 95% confidence interval 1.076, 1.639; P = 0.013). Overall numbers of cases discharged with poisoning fell. The proportion of these involving paracetamol in any form increased significantly in all groups except young men aged 10 to <20 years. Legislation has not reduced mortality or proportional use of paracetamol in overdose, both of which appear to have increased in Scotland since pack-size limitations. Other approaches are necessary to reduce the death rate from overdoses involving paracetamol.

Reduction in outpatient antibiotic sales for pre-school children: interrupted time series analysis of weekly antibiotic sales data in Sweden 1992–2002

The aim of this study was to use detailed weekly data on outpatient antibiotic sales for pre-school children in Sweden to test for the significance of trends during 1992-2002. We also report on the special features found in weekly antibiotic data, and how the interrupted time series (ITS) design can adjust for this. Weekly data on the total number of dispensed outpatient antibiotic prescriptions to pre-school children were studied, as well as the individual subgroups commonly used to treat respiratory tract infections in children: narrow-spectrum penicillins, broad-spectrum penicillins and macrolides. In parallel, monthly data of paracetamol sales of paediatric dosages were analysed to reflect trends in symptomatic treatment. An ITS model controlling for seasonality and autocorrelation was used to examine the datasets for significant level and trend shifts. A significant increase in mean and change in level could be found in the total antibiotic data in 1997, also reflected in broad-spectrum penicillin data where a similar trend break occurred in 1996. For macrolides, a trend break with a decrease in mean was noted in 1996, but no trend breaks were found in narrow-spectrum penicillin data. In contrast to the general decreasing trends in antibiotic sales, the yearly over-the-counter sales of paracetamol in paediatric preparations increased during the same period, with no identified trend breaks. The overall decrease in antibiotic sales and increase in paediatric paracetamol sales might suggest that symptomatic treatment in the home has increased, as antibiotics are less commonly prescribed.

The Safety Profile of Sustained Release Paracetamol During Therapeutic Use and Following Overdose

Sustained release (SR) formulations of paracetamol (acetaminophen) have been introduced in several countries to provide lasting pain relief and reduced risk of rebound pain. However, few studies have evaluated the safety of paracetamol SR formulations. To assess the available published safety data regarding SR formulations of paracetamol, the EMBASE and MEDLINE databases were searched from 1980 to June 2003 for published worldwide human experience with paracetamol SR formulations. All publications that included any information about ingestion of any paracetamol SR formulation were systematically reviewed and abstracted by trained staff. The literature searches returned a total of 14 references containing safety data on paracetamol SR. In addition, the Toxic Exposure Surveillance System (TESS) of the American Association of Poison Control Centers (AAPCC) database was searched for human exposure cases. The TESS database yielded 3003 cases from 1994 to 2002 that involved a paracetamol SR product. The available information indicates that the adverse event and safety profile of paracetamol SR is very similar to immediate release (IR) formulations of paracetamol. During therapeutic use, minor effects such as gastrointestinal upset and headache may occur. The rate of these effects varies substantially among studies but overall does not appear to be different between the SR and IR formulations of paracetamol. Overdose with paracetamol SR is expected to cause liver injury similar to overdose with IR formulations. The number of human exposure cases has increased since introduction of the SR formulation; however, sales of the SR formulation amounted to 7.5% of all paracetamol sales but accounted for 2.5% of the cases reported to poison centres. There were two deaths recorded in the TESS database: both were the result of multiple drug ingestion. No cases of death or unusual types of toxicity have been described from an overdose of paracetamol SR alone.

Restricting paracetamol in the United Kingdom to reduce poisoning: a systematic review

Paracetamol poisoning is implicated in about 150-200 poisoning deaths per year in England and Wales. We review previous studies assessing the effectiveness of regulations introduced in 1998 to restrict sales of paracetamol and reduce paracetamol poisoning. We searched the following electronic databases: MEDLINE, EMBASE, CINHAL, HIMIC, COCH, APC, CENTRAL and DARE. English language publications between 1998 and 2003 were included. Studies were included if they took place in the United Kingdom and assessed changes in any aspect of paracetamol poisoning following the introduction of the 1998 regulations. Twelve studies were identified, which examined several different outcomes. Three studies examined admissions to liver transplant units; all reported reductions. Eight studies evaluated severity of paracetamol poisoning; three reported reductions but five did not. Five out of six studies reported reductions in hospital admissions. One study reported reduced mortality in England and Wales after 1 year while another found no difference in Scotland 2 years after the regulations were introduced. Two studies observed a significant reduction in over-the-counter sales. Studies suffered from several limitations including short follow-up periods, no case definition for paracetamol poisoning and lack of comparison groups. The limitations of these studies makes it difficult to draw firm conclusions. They do, however, suggest that the 1998 regulations may have been associated with reduced admissions to liver units and liver transplants, reduced hospital attendance due to paracetamol poisoning and reduced sales of paracetamol. Further research is needed to fully evaluate the impact of the 1998 regulations. In the future, formal evaluation of the impact of similar interventions should be an integral part of policy formation.

Restricting Sales of Paracetamol Tablets: Effect on Deaths and Emergency Admissions for Poisoning in Scotland 1991 – 2002

To identify any effect on deaths and emergency admissions for poisoning resulting from the restriction on paracetamol sales introduced in September 1998. Scotland. 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. 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. 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. 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. Restricting paracetamol sales resulted in significant health gain. Further restrictions and public education on this valuable but dangerous drug are both urgently needed.

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.

Paracetamol sales and atopic disease in children and adults: an ecological analysis.

The authors recently observed that frequent paracetamol use was positively associated with asthma and rhinitis in young adults. Therefore, an ecological analysis was performed to measure international associations between paracetamol sales and atopic disease prevalences in children and adults. Published data from the International Study of Asthma and Allergies in Childhood (ISAAC) on the prevalence of four atopic symptoms in 13-14-yr-olds (112 centres) and 67-yr-olds (66 centres) in 1994/1995, and European Community Respiratory Health Survey (ECRHS) data on the prevalence of asthma symptoms, diagnosed asthma and rhinitis (44 centres), prevalence of atopy, mean bronchial responsiveness and mean total immunoglobulin E levels (34 centres) in young adults in 1991/1992, were used. Their associations with national 1994/1995 per capita paracetamol sales were measured using linear regression. Paracetamol sales were high in English-speaking countries, and were positively associated with asthma symptoms, eczema and allergic rhinoconjunctivitis in 13-14-yr-olds, and with wheeze, diagnosed asthma, rhinitis and bronchial responsiveness in adults. The prevalence of wheeze increased by 0.52% in 13-14-yr-olds and by 0.26% in adults (p<0.0005) for each gram increase in per capita paracetamol sales. These ecological findings require cautious interpretation, but raise the possibility that variation in paracetamol usage may explain some of the variation in atopic disease prevalence between countries.

Prescribing patterns for analgesics in relation to underprivileged area (UPA) score, mortality and suicide in 33 municipalities in the province of Skåne, southern Sweden.

Although it is well known that analgesics contribute to suicide, there is little knowledge about how much of the mortality and suicide can be explained by socioeconomic deprivation or by sales of analgesics. This ecological study analyses the relationships between the sales (defined daily doses per 1000 inhabitants per day) of dextropropoxyphene, dextropropoxyphene combinations, paracetamol, codeine and paracetamol combinations, and other codeine combinations and the Swedish UPA (underprivileged area) score, mortality and suicide rates in 33 municipalities in Skåne in 1987 and 1994 for people aged 20-64 years. The association of each of the subgroups of analgesics with all-cause mortality, and with standardised mortality rates for suicide, adjusted for UPA score, was investigated by using weighted (by population size) regression analysis. In 1994 there was a moderate to strong significant correlation between sales of analgesics and UPA scores, mortality and suicide (r = 0.49-0.78). Although UPA score explained 68.9% and 67.4% respectively of the variance between the analgesics and all-cause mortality and suicide, codeine and paracetamol combinations explained a further 10.1% of the variance in suicide. Dextropropoxyphene and codeine and paracetamol combinations explained an additional 3.8% and 2.9% respectively of the variance in mortality. Local prescription rates for analgesics were associated with mortality and suicide, when adjusted for socioeconomic deprivation defined as UPA score.

Use of paracetamol for suicide and non-fatal poisoning in the UK and France: are restrictions on availability justified?

OBJECTIVE: To investigate the relationship between the availability of paracetamol and its use for overdose and suicide. DESIGN: Analysis of routinely collected information on time trends for paracetamol suicides, non-fatal...

Consumption, overdose and death from analgesics during a period of over‐the‐counter availability of paracetamol in Denmark

During the period 1978-1986, annual sales of paracetamol in Denmark increased from 1 million defined daily doses (DDD) (3 g) to 47 million DDD, while the number of admissions and deaths from overdose increased from 26 to 202 and from 1 to 3-4, respectively. The corresponding figures for salicylates are a decrease in sales from 113 to 94 million DDD, an increase in admissions from 282 to 595, and an increase in deaths from 5 to 22. From 1 January 1984 paracetamol became available on an over-the-counter basis. The figures for 1983 and 1984 were an increase in sales from 14 to 28 million DDD, an increase in admissions from 114 to 198, and an increase in deaths from 0 to 4. The number of deaths from opioid overdose remained constant at a value of about fifty during this period, the mortality per dose being about 20-fold higher than for paracetamol and salicylates. Dextropropoxyphene-related deaths increased twofold to 121 in 1986, with unchanged sales figures. A campaign launched by the National Board of Health resulted in a reduction in the number of deaths from dextropropoxyphene to 66 in 1987. The main effect of over-the-counter release of paracetamol was a dramatic increase in sales, without the epidemic of deaths observed a decade ago in the UK. It is suggested that the higher mortality of paracetamol poisonings in the UK compared to Denmark is related to the dextropropoxyphene content of the combination product, which is not available in Denmark. From an epidemiological toxicological viewpoint such combinations are not justified.