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University of Southern Denmark
Availability of Paracetamol Sold Over the Counter in Europe
A Descriptive Cross-Sectional International Survey of Pack Size RestrictionMorthorst, Britt Reuter; Erlangsen, Annette; Nordentoft, Merete; Hawton, Keith; Hoegberg,Lotte Christine Groth; Dalhoff, Kim Peder
Published in:Basic & Clinical Pharmacology & Toxicology
DOI:10.1111/bcpt.12959
Publication date:2018
Document version:Accepted manuscript
Citation for pulished version (APA):Morthorst, B. R., Erlangsen, A., Nordentoft, M., Hawton, K., Hoegberg, L. C. G., & Dalhoff, K. P. (2018).Availability of Paracetamol Sold Over the Counter in Europe: A Descriptive Cross-Sectional International Surveyof Pack Size Restriction. Basic & Clinical Pharmacology & Toxicology, 122(6), 643-649.https://doi.org/10.1111/bcpt.12959
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This article has been accepted for publication and undergone full peer review but has not
been through the copyediting, typesetting, pagination and proofreading process, which may
lead to differences between this version and the Version of Record. Please cite this article as
doi: 10.1111/bcpt.12959
This article is protected by copyright. All rights reserved.
Article Type: Original Article
Availability of Paracetamol Sold Over-the-Counter in Europe: A
Descriptive Cross-Sectional International Survey of Pack Size
Restriction
Britt Reuter Morthorst1,2, Annette Erlangsen2,3,4, Merete Nordentoft1,2, Keith Hawton5, Lotte Christine Groth Hoegberg6 and Kim Peder Dalhoff7 1Faculty of Medical and Health Science, University of Copenhagen, Copenhagen, Denmark 2Danish Research Institute for Suicide Prevention, Research Unit, Mental Health Centre Copenhagen, Copenhagen, Denmark 3Department of Mental Health, Johns Hopkins School of Public Health, Baltimore, MD, USA 4Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark 5Centre for Suicide Research, University Department of Psychiatry, Oxford University, Oxford, UK 6Department of Anaesthesiology, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark 7Department of Clinical Pharmacology and Clinical Toxicology, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark Author for correspondence: Britt Reuter Morthorst, Danish Research Institute for Suicide Prevention, Research
Unit, Mental Health Centre Copenhagen, Kildegaardsvej 28, 2900 Hellerup, Denmark (e-mail: [email protected]).
Keywords: Paracetamol; poisoning; pack size restrictions; Poisons Information Centres. (Received 22 August 2017; Accepted 27 December 2017) Acknowledgement The authors are grateful to the EAPCCT and especially their general secretary Mark Zammit for his professional handling of our request. This study would not have been possible without his dedicated collaboration. The authors would also like to thank all participating members of EAPCCT who provided data.
Abstract
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
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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 multicentre 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-
30 grams). 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.
Suicidal behaviour constitutes a global health burden with close to one million deaths
annually and 10-40 times as many episodes of self-harm [1]. In European countries,
poisonings account for the major part of hospital-presenting deliberate self-harm, and
analgesics, especially paracetamol, are frequently used for intentional self-poisoning [2-5].
Mild analgesics including paracetamol are sold in all European countries with or without
prescription and often in large quantities. Yet, intentional and accidental self-poisoning with
especially paracetamol represents a significant healthcare problem [4,6,7]. The proportion
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of paracetamol-related poisonings related to all poisonings varies among European
emergency departments; ranging from 4.5 % as reported in Spain [8] to 12% in Norway [9]
and 40-44% in the UK over the past decades [10]. Poisons Information Centres (PICs) which
answer enquiries , including those related to paracetamol, are established in most European
countries [11]. A comparison of PICs worldwide showed that paracetamol was among the
20 most frequent agents for which enquiries were made [12]. However, the association
between paracetamol sold over-the-counter (OTC) in pharmacies and non-pharmacy
outlets and number of enquiries to PICs is sparsely described and with conflicting findings
[13,14]. A British report found no decrease of paracetamol-related enquiries when
comparing frequencies before and after implementation of the British pack size restriction
on paracetamol [15]. However, an Irish report showed a decrease in severity of paracetamol
poisonings and number of tablets taken, as recorded from paracetamol-related enquiries,
after the Irish pack size restriction had been introduced [16]. During 2010-2013, the Swedish
Medical Agency reported a marked increase in paracetamol-related enquiries, arguing that
this was related to the introduction of sales in non-pharmacy outlets in November 2009
[13]. This was supported by an earlier Swedish report that related a 158% increase (50%
within the first three years) in the number of paracetamol-related PIC enquiries to the same
legislative change [17].
Paracetamol may be hepatotoxic when ingested in doses exceeding daily recommendations
[7,18,19]. Gulmez and colleagues noted that a liver transplant was needed in 0 - 52% of ALF
cases due to overdose by paracetamol in a sample mainly from the UK and Ireland. The
same report revealed that nearly 97% of all ALF overdose cases were due to paracetamol
poisoning [20], though varying across Europe [21]. The relatively low case fatality rate is
partly explained through high standards in clinical practice [22], including treatment with
the antidote, N-acetylcysteine [23].
Suicidal behaviour is a complex phenomenon, with suicidal ideation and actions fluctuating
over time [24]. Impulsive suicidal behaviour, which is particularly prevalent among the
young, implies that the person would tend to use means available in close proximity, e.g.
agents available in the household [25,26]. One suicide preventive measure is to restrict
access to potentially toxic drugs like paracetamol [27-29] and restrictions on pack sizes of
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mild analgesics including paracetamol sold OTC have been introduced in several European
countries [30]. A structured overview of the availability of paracetamol tablets OTC and its
association with self-poisoning was published in 2000 for European countries [4]. However,
an update is due. The primary aim of the present study was to gain an updated overview of
restrictions on paracetamol sold OTC in pharmacy and non-pharmacy outlets in Europe.
Secondly, we wanted to investigate the association between frequency of paracetamol-
related enquiries to PICs and availability of the drug.
Methods
Design and setting
We conducted a European multicentre study in a cross-sectional design during 2015 and
2016 describing the availability status of paracetamol sold OTC in European pharmacies and
other retail outlets.
PICs in all European countries were contacted using the European Association of Poisons
Centres and Clinical Toxicologists (EAPCCT) member lists. The EAPCCT is a scientific
association with individual members rather than countries. Currently, it includes members
from 29 countries, covering all major countries in Europe.
Data
A detailed survey questionnaire was developed and distributed via email to all current
members by the EAPCCT secretary during March 2015 (see Appendix). Responses were
returned directly via e-mail to the corresponding author, and data were entered into an
electronic database. Responses were reviewed by two researchers or through follow-up
enquiries to the respective PIC in order to clarify unclear information. Where we received
several responses from the same country, responders were contacted with the aim of
settling potential differences. Responses with national level data were preferred.
The survey included questions regarding: description of PIC; national availability of
paracetamol tablets; pack size restrictions in pharmacies and non-pharmacy outlets;
number of tablets and grams sold OTC and presence of blister package products; services
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provided by the local PIC (calls, hotline, web contacts or ward activity); annual numbers of
paracetamol-related enquiries as well as total number of enquiries for the years 2011-2013;
risk assessment of poisoning enquiries using the standardized Poisoning Severity Score, as
introduced by EAPCCT in 1990 [31]; access to hospital records, discharge letters; and other
services, such as Ministry consultancy, educational activities or surveillance functions.
Missing data
A reminder was dispatched five months after the initial questionnaire by the EAPCCT
general secretary. PICs in non-responding countries were followed up with emails. Lastly,
aggregate data on enquiries to PICs were downloaded from the website of the UK National
Poison Information Services since no personal reply was achieved from the UK, and this
procedure was recommended by leading British toxicologists [32].
Analysis
Descriptive analysis was supplemented by non-parametric tests of differences. A normal
distribution could not be assumed with respect to mean proportions of paracetamol-related
enquiries of all poisonings to PICs due to significant outliers observed in data from two
countries. This meant that calculations were based on medians. This also applied to the
calculation of rates where a normal distribution of either observed or estimated means
could not be assumed; hence not supporting Poisson regressions. The Wilcoxon and Mann-
Whitney U test of differences, respectively, were applied to determine differences among
countries with and without pack size restrictions, as well as among those with and without
non-pharmacy outlet sales.
Ethical considerations
Ethical approval was not required as no person-level data were collected.
Results
In total, 21 European PICs or EAPCCT members responded. According to the EAPCCT
website, there are currently PICs in 29 European countries. Assuming that all members in
the possible 29 European countries had received the survey, the country-based response
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rate was 72.4%. We obtained responses from 18 PICs covering nationwide information,
while three PICs provided information at a sub-national level (Munich, Germany; Lodz,
Poland; and Moscow, the Russian Federation).
Pack size restrictions
In 14 (67%) of the responding countries, pack size restrictions had been implemented in
pharmacies (range: 8 to 30 grams in blister packages) (Table 1). Countries where pack size
restrictions had not been introduced were predominantly Eastern European (Slovakia,
Lithuania, Croatia, Czech Republic, Poland (Lodz) and the Russia Federation (Moscow)). In 12
(57%) countries, mild analgesics including paracetamol were not available in non-pharmacy
outlets. Respondents from all countries confirmed that larger quantities of paracetamol
were available to patients through prescription from their primary care doctor.
Enquiries to PICs about poisonings
Only countries where information on annual paracetamol-related enquiries and total
number of enquiries (n= 17) had been reported were included in further analyses. Rates of
enquiries per 100,000 inhabitants from the public were presented for the year 2013 for
countries providing these services (n=18) (Table 2).
Despite the fact that pack size restrictions have been implemented in the UK, Ireland and
Sweden, a larger proportion of paracetamol-related enquiries was noted in these countries
compared to others (Table 2). Yet, at the same time, mild analgesics including paracetamol
were available in non-pharmacy outlets. Most countries where paracetamol was sold in
non-pharmacy outlets had a proportionally higher percentage of annual mean number of
paracetamol-related enquiries when compared to countries with no such sales. France was
an exception to this. Two significant outliers regarding mean paracetamol-related enquiries
were identified (Table 2), leading to the necessity for using non-parametric tests of
differences for median proportions of paracetamol-related enquiries, presented in Table 3.
No significant difference in paracetamol-related enquiries were found among countries with
pack size restriction (range 1.1% to 16.1%) and countries without pack size restriction (range
1.7% to 5.6%); median difference 0.7%, p = 0.36. However, a significant difference was
noted for median proportions of paracetamol-related enquiries among countries with no
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non-pharmacy outlet sales (range 1.1% to 5.3%) and those with non-pharmacy outlet sales
(range 1.9% to 16.1%); median difference 2.2%, p = 0.02 (Table 3).
We found a shift in impact of paracetamol-related enquiries when calculated as rates per
100,000 inhabitants. The rates ranged between 1.1 in Croatia to 39.7 per 100,000
inhabitants in Sweden; implying that Sweden had the highest rate of enquiries. The non-
parametric test revealed that the mean rate of paracetamol-related enquiries to PICs was
higher in countries with pack size restrictions than in those with no pack size restrictions
(p=0.027) (Table 3). Also, a higher mean rate of paracetamol-related enquiries per 100,000
inhabitants was noted in countries with non-pharmacy outlet sales of paracetamol when
compared to those with no non-pharmacy outlet sales (p=0.019).
In three of 21 countries (Slovenia, The Netherlands and the UK), PIC services were provided
for clinicians only. In spite of the vast majority of countries providing services for both
clinicians and the public, we found large differences in rates of public enquiries among
countries (Table 2). The rates varied from 0.7 in Slovakia to 609.5 per 100,000 inhabitants in
Belgium. All responding PICs provided phone hotline services, while 11 (55%) offered
personal consultations and 13 (65%) supported web-based enquiries. Action cards (stepwise
information on risk assessment and treatment guidelines) were available from five of the
PICs (26%), while other services were supplied by 16 of the centres (80%). These covered:
special ward facility, insurance or Ministry consultancy, educational activities and
surveillance functions. Five centres (24%) were able to systematically access hospital
records, including information on diagnosis codes, while nine centres (43%) had access to
discharge letters. Routine risk assessment of the level of paracetamol poisoning was
performed by 17 of the PICs (77%), of which 8 (36%) applied the Poisoning Severity Score,
the severity grading scale suggested by the EAPCCT [31].
Discussion
This is, to our knowledge, the first study to examine the impact of pack size restrictions and
non-pharmacy availability of paracetamol in Europe based on data from European PICs. Pack
size restrictions on pharmacy sales of paracetamol have been implemented in two thirds of
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the examined countries. There was no difference in the proportion of population-based
paracetamol-related enquiries (per 100,000 inhabitants) to PICs among countries which had
and had not implemented pack size restrictions. However, there was a higher population-
based rate of paracetamol-related enquiries in countries where mild analgesics including
paracetamol were sold in non-pharmacy outlets.
The fact that level of enquiries seemingly did not depend on whether pack size restrictions
had been introduced might seem surprising, especially considering the strong evidence from
the UK that pack size restrictions were linked to substantial reductions in deaths from
paracetamol poisoning [33]. However, our findings may reflect a greater pressure to reduce
pack sizes in countries in which the incidence of paracetamol overdoses is high.
The finding that paracetamol-related enquiries are greater where non-pharmacy sales are
permitted is supported by a Czech study in 2004 where the number of enquiries concerning
pharmaceuticals including paracetamol and ibuprofen over a five-year period rose following
a legislative change allowing sales in non-pharmacy outlets [34]. In Norway, sale of
paracetamol in non-pharmacy outlets was introduced in 2003. A subsequent study showed
no difference in number of hospital contacts for paracetamol overdoses when comparing
the two years before and after the legislative change, although an increase in the number of
paracetamol-related enquiries to PICs was noted. However, the authors concluded that the
severity of paracetamol poisonings had decreased [14]. In Sweden, sales outside pharmacies
were introduced in 2009; during the following four years, a 40% increase in paracetamol-
related poisonings was noted using national register data on hospital admissions and causes
of death [35]. A similar increase in paracetamol-related enquiries to PICs was noted [13]. The
increase observed in Sweden was associated with the liberalisation and as a direct consequence of
this, sales of paracetamol as regular tablets were withdrawn from non-pharmacy outlets in
2015, leaving only effervescent tablets on the market (that were not associated with an
elevated toxicity risk) [13]. One should think that the Swedish approach of pack size
restrictions in pharmacies and no sales in non-pharmacy-outlets might ensure that
paracetamol are available in a safer and controlled manner. However, the total number of
PIC consultation related to paracetamol poisoning has continued to increase in Sweden [36].
Long-term studies are needed to determine the effect of the intervention, possibly using
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data on hospital admissions for poisonings. In Denmark, another legislative change prior to
pack size restriction was implemented in March 2011. This legislation prohibited sales of
mild analgesics including paracetamol to minors below 18 years of age. However, it is not
known if this had an impact on hospital contacts due to overdose.
We found that the PICs in the UK and Ireland had particularly high frequencies of
paracetamol-related enquires (16% and 15% of all inquiries, respectively) compared to the
other participating countries. This matches national reports stating that paracetamol
intoxication is the most common poisoning in the UK and Ireland [32,37]. It is also well
documented that rates of self-harm by overdose of paracetamol, recorded as hospital
contacts in the UK and Ireland are substantially higher [38] than in other European countries
[2].
Examination of the impact of paracetamol-related enquiries when based on population size
(rates per 100,000 inhabitants) changed the picture. The highest rates were then found in
Sweden, with a mean rate of 38.7 per 100,000. This finding is clearly in line with the above-
mentioned most recent legislative decision to withdraw sales of regular paracetamol tablets
from all non-pharmacy outlets [13]. Future Scandinavian studies investigating the impact of
the ban on sales from non-pharmacy outlets on population-based hospital and PIC data also taking
prescription patterns into account will provide important information for public health policy
makers.
One essential difference in PICs across Europe was the target group in that 18 (86%)
provided services for both clinicians and the public, whereas in the remaining three
countries PICs only provided services for clinicians. Typically the latter types of PICs will refer
public enquiries on to GPs. Among PICs which provided services to both clinicians and the
public, rates of public enquiries differed significantly possibly suggesting different levels of
public awareness. A steady increase in the number of public enquiries has been noted by
PICs [16,39]. Some PICs use public awareness campaigns and social media initiatives to
increase public awareness [40].
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We found that among the responding countries, it seemed that pack size restriction was
accepted as a suicide prevention strategy, in spite of very few national evaluations of this
initiative [4,41]. Evidence in favour of the pack size restriction has been reported through
significantly reduced paracetamol-related deaths and also referrals for liver transplantation
[41].
Strengths and Limitations
Data were provided by experts in the field of toxicology and representatives from European
PICs with access mainly to national level enquiry data. Due to the close collaboration with
EAPCCT, which distributed the questionnaire and e-mail reminders, an estimated response
rate of 72% was obtained. This contrasts previous investigations involving EAPCCT
members, which have reported response rates of less than 30% [4,12]. No uniform,
international data sources are available in this area; hence, the current data collection can
be viewed as unique.
Although a structured questionnaire was used, we obtained heterogeneous replies, and
answers from several PICs were incomplete. The lack of response from larger countries,
such as Spain and Portugal, is unfortunate. It was not possible to examine whether
legislative rules regarding number of packages allowed in single sales played a role due to
lack of responses. Availability in households of paracetamol-related drugs does not solely
depend on availability OTC; a substantial share of the population will have obtained the
drugs through prescription, which was not feasible to assess in this study.
It would have been preferred to have complete data on sales of paracetamol. However, this
would not have been feasible without having to compromise the number of reporting
countries.
The difference in service provision between accepting enquiries from clinicians only or from
both clinicians and the public is unfortunate when examining enquiries as a surrogate
outcome; we have met this limitation by calculating rates of enquiries from the public for
the year 2013 where data were obtained. Only three countries did not take public enquiries,
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namely Slovenia, The Netherlands and the UK. It could be argued that their enquiries might
be related to more severe cases; however, it was not feasible to address level of severity in
this survey, such as through a poisoning severity score.
The term ‘paracetamol-related enquiries’ might have been differently interpreted by
responders, ranging from mild poisonings to severe cases. It might also have been unclear
whether multi-drug poisonings should be included or not. This level of detail could
unfortunately not be addressed in the questionnaire. Although self-poisonings with
paracetamol is frequent in European countries, there is likely to be variation in self-harming
methods among countries [2,4]. Hence, it would be fair to state that not only restrictions
but also cultural habits may influence the pattern in methods used for self-harm. Future
analysis would benefit from national data on hospital admissions for poisonings as well as
other relevant clinical outcomes.
To conclude, in most European countries, clinicians and the public have access to treatment
advice on paracetamol-related poisonings through PICs. In the majority of examined
countries, pack size restrictions have been implemented for mild analgesics including
paracetamol sold OTC in pharmacies. Countries with no pack size restriction in pharmacies
and no sales in non-pharmacy outlets had fewer paracetamol-related enquiries to PICs. One
conclusion would be that pack size restriction has no influence on the number of
paracetamol poisoning, whereas not selling paracetamol OTC has. However, the lack of
significant difference in the proportion of enquiries among countries with no pack size
restriction and those with pack size restriction indicates a need for further research using
national data and toxicity-related outcomes. The higher rate of paracetamol-related
enquiries in countries where mild analgesics including paracetamol were available in non-
pharmacy outlets could suggest that more restrictive measures might be advisable.
Conflict of interest
None.
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[31] Persson HE, Sjoberg GK, Haines JA, et al. Poisoning severity score. Grading of acute poisoning. J
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Table 1 European PICs, their year of establishment, pack size restriction on paracetamol in
pharmacies, and sales in non-pharmacy outlets by country
PIC Year of
establis
hment
of PIC
Area of
coverage
OTC
Pharmacy
sales
(gram)
Non-
pharmacy
outlet sales
(gram)
Countries with
restriction (n=14)
Austria Poisons Information Center
Vienna 1975 National 30 No sale
Belgium Anti-Poison center of Belgium 1963 National 10 No sale
Denmark Information Center Danish
Poison 2006 National 10 5
France Toxic vigilance Coordination
Committee and Association of
French Poison Centers
1999 National 8 No sale
Finland Finnish Poison Center 1961 National 15 No sale
Germany/Munich Poison Information Center
Munich 1968 Regional 10 No sale
Iceland Iceland Poison Center 1994 National 15 No sale
Ireland National Poison Information
Center Ireland 1966 National 12 6
Italy Florence Poison Center & Pavia
Poison Control Center 1991 National 15 No sale
Norway Norwegian Poisons Information
Center National 10 5
Slovenia Poison Control Centre, Division of
Internal Medicine, Ljubljana 1973 National 10 No sale
Sweden Poison Information Center
Sweden 1960 National 10 No sale*
Switzerland Tox Info Suisse 1966 National 8 No sale
UK National Poison Information
Services England (Toxbase 1982) 1962
National 16 8
Countries without
restriction (n=7)
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Croatia Poison Control Center Zagreb 1970 National Unlimited No sale
Czech Republic Toxicological Information Center
of Czech Republic (TIC) 1964 National Unlimited 6
The Netherlands Dutch Poison Information Center 1959 National Unlimited No sales
Lithuania Poison Information Bureau 2012 National Unlimited No sale
Poland/Lodz Poison Information Center 1967 Regional Unlimited 6
Russian
Federation/Moscow
Research and Applied Toxicology
Center of Medical and Biological
Agency
1993 Regional Unlimited Unlimited
Slovakia Research and Applied Toxicology
Center of Medical and Biological
Agency
1968 National Unlimited No sale
* In 2015, Sweden withdrew sales of mild analgesics including paracetamol (10 g) from non-
pharmacy outlets sold as regular tablets leaving only effervescent tablets on the market.
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Table 2 Paracetamol-related enquiries to PICs according to pack size restrictions and sales through non-pharmacy outlets in Europe in the
period of 2011-2013
Country
Mean percent of
paracetamol-
related enquiries of
all poisonings (%)
Overall rate of
enquiries per 100,000
inhabitants and
(paracetamol-related
enquiries) 2011-2013
Rate of public
enquiries per 100,000
inhabitants in 2013
Pack size restriction
in pharmacy
Sales restricted to
pharmacies Italy 2.7 61.0 (1.66) 10.7
France 5.3 289.6 (15.45) 170.6
Belgium 2.6 ** 714.5 (12.55 **) 609.5
Slovenia¹ 3.9 ** 83.9 (3.23 **) Clinicians only
Austria 1.1 283.7 (3.06) 1
Iceland Missing **** Missing **** Missing ****
Switzerland 3.4 456.0 (15.39) 296.2
Germany (Munich) 2 Missing ***** Missing *****
Finland 3 566 (17.12) 14.5
Available in non-
pharmacy outlets Ireland 16.1 * 212.8 (34.14) 59.3
Norway 3.4 792.2 (27.03) 504.7
Sweden 4.7 854 (39.68) 606.4
UK¹ 14.9 * 64.9 (9.69) Clinicians only
Denmark 5.4 380.4 (20.67) 173.6
No pack size Sales restricted to Slovakia 3.4 77.7 (2.60) 0.7
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restriction in
pharmacy
pharmacies
Lithuania 1.7 77.5 (1.32) 45.5
Croatia 2.7 40.3 (1.08) 7.3
Available in non-
pharmacy outlets Czech Republic 2.7 153.3 (3.58) 61.6
Moscow (Russian
Federation) 1.9*** Missing ****** Missing ******
The Netherlands ¹ 5.6 264.3 (14.79) Clinicians only
Poland (Lodz) 5 Missing ***** Missing *****
* Significant outliers of mean frequencies
** Data only available for 2012 and 1013
*** Data only available for 2013
**** Data not available, hence Iceland not included in the analysis.
***** Only regional data available
****** Only city data available
¹ In Slovenia, The Netherlands and the UK PICs provide services for clinicians only
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Table 3 Differences in paracetamol-related enquiries to PICs according to pack size restrictions and sales through non-pharmacy outlets a
Median percent of
paracetamol-
related enquiries of
all poisonings 2011-
2013 (%) (range)
Median
difference
(%)
p-valueb
Rate of
paracetamol-
related
enquiries per
100,000
inhabitants
Mean difference
(95 % CI) p-valueb
Pack size restriction
in pharmacies
Yes (n = 13) 3.4 (1.1 – 16.1) 16.64
No (n = 7) 2.7 (1.7 – 5.6) 0.7 0.362 4.67 -11.97
(-21.25 to -2.68) 0.027*
Packages available
in non-pharmacy
outlets
Yes (n = 9) 4.9 (1.9 – 16.1) 21.37
No (n = 11) 2.7 (1.1 -5.3) 2.2 0.02* 7.35
-14.02
(-26.39 to -1.66)
0.019*
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a Based on countries where regional or national data were available. b Using the Wilcoxon test and Mann-Whitney U test, respectively
* Significance level 0.05