Open Access
Research
Stephanie M Lau,1,2 Treasure M McGuire,3,4 Mieke L van Driel5
To cite: Lau SM,
McGuire TM, van Driel ML.
Consumer concerns about
paracetamol: a retrospective
analysis of a medicines call
centre. BMJ Open 2016;6:
e010860. doi:10.1136/
bmjopen-2015-010860
▸ Prepublication history and
additional material is
available. To view please visit
the journal (http://dx.doi.org/
10.1136/bmjopen-2015010860).
Received 14 December 2015
Revised 15 April 2016
Accepted 28 April 2016
1
Toowoomba Hospital,
Toowoomba, Queensland,
Australia
2
School of Medicine, The
University of Queensland,
Brisbane, Australia
3
School of Pharmacy,
The University of Queensland,
Woolloongabba, Brisbane,
Australia
4
Mater Pharmacy Services,
Mater Health Services,
Brisbane, Australia
5
Discipline of General
Practice, School of Medicine,
The University of Queensland,
Royal Brisbane Women’s
Hospital, Herston, Brisbane,
Australia
Correspondence to
Mieke L van Driel;
m.vandriel@uq.edu.au
ABSTRACT
Objectives: To identify consumer information needs
about paracetamol, the most commonly used analgesic
and antipyretic worldwide.
Design: Retrospective analysis of medicines questions
from the public.
Setting: Australian consumer medicines call centre.
Participants: Callers to National Prescribing Service
Medicines Line between September 2002 and June
2010 (n=123 217).
Main outcome measures: Enquiry profile:
demographics, enquiry type and concurrent medicines
included in paracetamol calls; question themes derived
from subset of call narratives.
Results: Paracetamol comprised part of the enquiry in
5.2% of calls (n=6367). The caller age distribution for
paracetamol calls was skewed towards a younger cohort,
with 45.2% made by those aged 25–44 vs 37.5% in ‘rest
of calls’. Significantly more paracetamol-related calls
were made for a child (23.7%) compared with ‘rest of
calls’ (12.7%, p<0.001). The most frequent concurrently
asked about medicines were codeine (11%, n=1521) and
ibuprofen (6.4%, n=884). Questions underpinned by
paracetamol risk (interaction, use in pregnancy/lactation
or other safety concerns) predominated (55.8%). When
individual paracetamol enquiry types were compared with
‘rest of calls’, efficacy was most frequent (24.9% vs
22.8%); however, interaction (21.5% vs 14.8%),
administration (15.5% vs 11%) and pregnancy/lactation
(13.8% vs 8.3%) categories were more prevalent for
paracetamol calls (all p<0.001). Enquiry type frequency
also varied by patient age group, with questions about
administration more common in younger groups and
efficacy dominating in those over 45. Narrative analysis of
over-represented paracetamol enquiry types showed
specific concerns relevant to life stages: young children,
those of reproductive age and the elderly.
Conclusions: Consumers have many concerns about
the use of paracetamol that may be under-recognised by
healthcare providers, with the nature of enquiries
differing across life stages. These concerns are not
adequately addressed by available consumer information.
Improving access to targeted information about
paracetamol would promote the safe and effective use of
this common medicine.
INTRODUCTION
Paracetamol is the most commonly used
analgesic and antipyretic worldwide and is
Strengths and limitations of this study
▪ Our database of over 100 000 calls made over
eight consecutive years by the Australian helpseeking public represents an untapped resource
for identifying consumer medicines information
gaps and concerns.
▪ The large sample size of paracetamol calls
enabled unique questions for various patient life
stages to be identified.
▪ Collected data permitted both quantitative and
narrative analysis, giving detailed insight into
consumer concerns, particularly in the areas of
interaction and administration of paracetamol.
▪ Limitations include sampling bias; people who
contact medicines call centres may have different
information needs from the wider population.
widely available over the counter (OTC) in
the UK and Australia.1 2 Although its mechanism of action is poorly understood, paracetamol remains popular due to tolerability
and safety when taken at recommended
doses. However, in an overdose—whether by
a large single dose or repeated supratherapeutic dosing—3irreversible hepatotoxicity
represents a global source of morbidity.4–7
The serious health ramifications of the
potential and proven misuse of paracetamol
demonstrates an opportunity for improvement in the provision of consumer-oriented
resources and justifies research into consumer information needs.
Despite its widespread use, consumer information needs about paracetamol have not
been well characterised in the literature. This
is highlighted by a recent British Medical
Journal (BMJ) editorial stating that ‘important questions remain unanswered’.2 While
the editorial sought to address three generalised questions about this common medicine,
paracetamol is used by distinct populations
spanning across life stages, who have varying
information-seeking priorities. These include
young children,8 pregnant women9 and the
elderly.10 For instance, since paracetamol is
commonly administered to infants, queries
Lau SM, et al. BMJ Open 2016;6:e010860. doi:10.1136/bmjopen-2015-010860
1
BMJ Open: first published as 10.1136/bmjopen-2015-010860 on 8 June 2016. Downloaded from http://bmjopen.bmj.com/ on June 5, 2020 by guest. Protected by copyright.
Consumer concerns about paracetamol:
a retrospective analysis of a medicines
call centre
Open Access
METHODS
Data collection
We used data from the National Prescribing Service
(NPS) MedicineWise (formerly NPS Medicines Line),
operated by clinical pharmacists of Mater Health
Services, Brisbane, between September 2002 and June
2010. This call centre was available to consumers
Australia-wide for medicine-related questions. Since data
from our observational study were originally routinely
collected as part of a health service without specific a
priori research goals, research was conducted and
reported in accordance with the REporting of studies
Conducted using Observational Routinely-collected
health Data (RECORD) guideline,17 an extension of the
STrengthening the Reporting of OBservational studies
in Epidemiology (STROBE) guidelines.18
Details of each call were captured on a standardised
form and entered into a Microsoft Access database.
These included demographics, enquiry type, relationship of caller to patient and motivation for calling. For
each call, up to three generic medicines relating to the
question were recorded and categorised by the
Anatomical Therapeutic Chemical (ATC) classification
system of medicines.19 Of the five ATC levels, we examined medicine classes at the ATC3 level, which labels
medicines according to their pharmacological subgroup
(eg, antihistamines-systemic), as well as at the ATC5
level, which identifies the chemical substance (eg, chlorpheniramine). Caller location was identified by postal
code and grouped by state/territory and Accessibility/
Remoteness Index of Australia (ARIA), a measure of the
remoteness of areas from service centres.20 The relative
population ratio was determined by dividing percentage
2
of paracetamol calls from each ARIA category by percentage of population living in each ARIA category.
Narrative for calls between January 2009 and June 2010
were also recorded electronically. Calls involving paracetamol in the question were extracted for analysis.
Remaining calls were classified as ‘rest of calls’. We
excluded calls that only involved a voicemail request for
Consumer Medicines Information (CMI) leaflets.
Quantitative analysis
We conducted a retrospective quantitative analysis on all
paracetamol-related calls. Comparisons between paracetamol and ‘rest of calls’ were performed using a χ2 test for
categorical data. Each call was originally coded for 1 of 25
enquiry types. These were collapsed into seven question
categories: ‘efficacy’ (indications for use, medicine comparisons, effectiveness for specific conditions or symptoms); ‘interaction’; ‘other safety’ (side effects or cautions
for use), ‘administration’ (dose, administration, formulation or storage issues); safety in ‘pregnancy and/or lactation’; ‘logistics’ (availability or cost) and ‘miscellaneous’.
Enquiry types were compared by patient age groups and
other life stages, for example, during pregnancy or breast
feeding. Concurrent medicines included in paracetamol
calls were also compared by age groups and a special
population, pregnant women. A two-sided p-value <0.05
was considered significant. The data were exported to
SPSS Statistics V.21 for analysis (IBM Corp. SPSS Statistics
for Windows, 23 edn. New York: IBM Corp, 2015).
Narrative analysis
Three highly ranked enquiry types where paracetamol
calls were over-represented compared with ‘rest of calls’
(‘interaction’, ‘administration’ and ‘pregnancy/lactation’) were selected for narrative analysis. Two investigators (SML and TMM) independently coded the content
of questions within each data set and created categories,
grouped under higher order headings or themes.
Coding differences were resolved through discussion
until consensus was reached. Themes for interaction
and administration calls were compared by age group.
Interactions were further explored based on whether
the call was: (1) directed towards a specific indication
( pain, cough and cold, etc); (2) sourcing information
on potential interactions for their medicines list including paracetamol or (3) incidental, where paracetamol
was not part of the enquiry.
RESULTS
A total of 123 217 calls were available for analysis. Of
these, 5.2% (n=6367) had paracetamol recorded as a
medicine directly relating to the question. Whether
paracetamol statistics were compared with ‘rest of calls’
longitudinally (annually) or collectively for the 8-year
period, enquiry demographics were remarkably consistent. Calls originated from all Australian states and territories, with metropolitan, rural and remote dwellers all
Lau SM, et al. BMJ Open 2016;6:e010860. doi:10.1136/bmjopen-2015-010860
BMJ Open: first published as 10.1136/bmjopen-2015-010860 on 8 June 2016. Downloaded from http://bmjopen.bmj.com/ on June 5, 2020 by guest. Protected by copyright.
from parents may differ in nature from those from the
general population.11 Additionally, paracetamol is available in various combination formulations such as
codeine for acute pain, with proven analgesic synergism.12 The diverse side effect profiles and indications
for combination products may result in unidentified differences in consumers’ information needs.
Consumers may seek information about medicines
from a variety of sources,6 including medical practitioners, pharmacists, the internet, medicines labelling
and information leaflets. For paracetamol, written information plays a significant role due to its OTC availability.
Health and medicines call centres are also used as a
resource in Australia13 and internationally.14–16 Studies
of queries handled by such helplines represent a largely
untapped repository for researching consumer medicines information gaps or concerns. This study aimed to
characterise consumer information needs about paracetamol through analysis of medicines call centre data.
This may serve to guide the practice of health professionals when prescribing or providing information about
this frequently used medicine, to promote its safe and
effective use.
Lau SM, et al. BMJ Open 2016;6:e010860. doi:10.1136/bmjopen-2015-010860
Pregnancy/lactation
Codeine
Ibuprofen
Pseudoephedrine
Doxylamine
Oxymetazoline
65+ Years
Codeine
Tramadol
Celecoxib
Meloxicam
Glucosamine
45–64 Years
Codeine
Ibuprofen
Oxycodone
Meloxicam
Dextropropoxyphene
25–44 Years
Codeine
Ibuprofen
Pseudoephedrine
Doxylamine
Tramadol
5–24 Years
Codeine
Ibuprofen
Promethazine
Pseudoephedrine
Dextropropoxyphene
1–4 Years
Ibuprofen
Codeine
Amoxicillin
Brompheniramine
Chlorpheniramine
<1 Year
Codeine
Ibuprofen
Pseudoephedrine
Oxymetazoline
Chlorpheniramine
BMJ Open: first published as 10.1136/bmjopen-2015-010860 on 8 June 2016. Downloaded from http://bmjopen.bmj.com/ on June 5, 2020 by guest. Protected by copyright.
well represented (relative population ratio living in each
ARIA category ranged between 0.6 and 1.09). The
majority of paracetamol calls were from females
(80.5%), which was not significantly greater than for
‘rest of calls’ (76.5%, p=0.05). There was a bimodal distribution for caller age, with peaks at 30 and 70 years.
Contrastingly, patient age distribution was trimodal, with
an additional peak at <1 year. Compared with ‘rest of
calls’, the distribution of caller age for paracetamol calls
was skewed towards a younger cohort, with 45.2% made
by the 25–44 age group versus 37.5% in ‘rest of calls’.
Paracetamol calls were significantly more often for
patients aged 14 and under (22.1%) versus ‘rest of calls’
(10.3%, p<0.001). Correspondingly, significantly more
paracetamol-related calls were made for a child (23.7%)
compared with ‘rest of calls’ (12.7%, p<0.001). Within
calls made about paracetamol, callers for children were
much more likely to be female (92.1%) than calls made
for themselves or others (76.8%, p<0.001). Over 90% of
paracetamol calls were prompted by one of three
reasons: inadequate information (47.9%), second
opinion (27.2%) or a worrying symptom (15%).
Compared with ‘\rest of calls’, more calls were made for
a second opinion (27.2% vs 23.3%, p<0.001).
The most frequent concurrently asked about medicines (ATC5) in paracetamol calls were codeine (11%,
n=1521) and ibuprofen (6.4%, n=884), with the remainder of concurrent medicines each comprising <2% of
paracetamol calls (in rank order: tramadol, dextropropoxyphene, oxycodone, pseudoephedrine, meloxicam,
diclofenac, celecoxib, aspirin). Of the top 10 medicines,
9 are indicated for analgesia, with pseudoephedrine (a
decongestant) the only exception. Codeine and ibuprofen were ranked first or second across all life stages
except in those aged 65 years or older, where tramadol
ranked second (table 1).
The most common pharmacological classes (ATC3)
included in paracetamol calls were non-steroidal antiinflammatory and antirheumatic medicines (12.8%,
n=1778), followed by cough suppressants (11.4%,
n=1578) (table 2). These were in the top three ATC3
classes across all patient age groups. The third ranked
class in the younger age groups (<1, 1–4, 5–24 years) was
antihistamines, with opioids ranking in the top three for
older groups.
Overall, enquiry types underpinned by paracetamol
risk predominated (interaction, use in pregnancy and/
or lactation or other safety concerns), constituting
55.8% of calls (table 3). When individual paracetamol
enquiry types were compared with ‘rest of calls’,
although efficacy was most frequent (24.9% vs 22.8%),
interaction (21.5% vs 14.8%), administration (15.5% vs
11%) and pregnancy/lactation (13.8% vs 8.3%) calls
occurred significantly more frequently for paracetamol
calls (all p<0.001).
The frequency of enquiry types also varied when compared by age groups. Administration enquiries were
more common in younger groups, comprising
Table 1 Top five Anatomical Therapeutic Chemical (ATC) fifth-level medicines included in paracetamol calls by age group
Open Access
3
Open Access
<1 Year
1–4 Years
5–24 Years
25–44 Years
45–64 Years
65+ Years
Cough
suppressants
Non-steroidal
anti-inflammatory
and antirheumatics
Antihistamines—
systemic
Non-steroidal
anti-inflammatory
and antirheumatics
Cough
suppressants
Antihistamines—
systemic
Cough
suppressants
Non-steroidal
anti-inflammatory
and antirheumatics
Antihistamines—
systemic
Cough
suppressants
Non-steroidal
anti-inflammatory
and antirheumatics
Opioids
Non-steroidal
anti-inflammatory
and antirheumatics
Cough
suppressants
Opioids
Non-steroidal
anti-inflammatory
and antirheumatics
Opioids
Cough
suppressants
approximately one-quarter of calls for patients aged
under 24 years (table 3). Conversely, efficacy predominated in older age groups, at nearly one-third of enquiries in those over 45. Logistics questions were more
common in this group, comprising 4.3–5.4% of enquiries in the over 45s vs 1.1–2.9% in younger groups. Calls
about safety also increased in incidence with age.
Enquiries about pregnancy and lactation were frequent
in age groups 0–4 and 25–44, most likely representing
infant and mother patient groups.
There were some differences in the call profile for
questions involving paracetamol alone versus those
involving a concurrently enquired about analgesic
(codeine or ibuprofen). Female callers predominated
for questions about efficacy, interactions or safety. For
paracetamol and ibuprofen calls, the caller was commonly of reproductive age (25–44 years) and asking on
behalf of a child in 39.0% of calls, which was significantly greater than for paracetamol calls without
ibuprofen (21.3%, p<0.001). In contrast, paracetamol
and codeine questions were more evenly distributed
across caller age range and were less frequently made on
behalf of a child (17.3% vs 22.9% for paracetamol calls
without codeine).
Narrative analysis
The enquiry types ‘interaction’, ‘administration’ and
‘pregnancy/lactation’ were selected for narrative analysis, with 65%, 58.7% and 57.5% of calls, respectively,
available for exploration of themes. A summary of narrative themes and question examples by life stage is provided in the online supplementary appendix tables 1
and 2.
Interaction calls
Fifteen themes were identified from 895 interaction
calls. The major theme was safety (85.1%, n=762), with a
small percentage addressing therapeutic strategy (6.1%,
Table 3 Frequencies of enquiry types for paracetamol and ‘rest of calls’ and enquiry types by age groups for paracetamol
calls
Paracetamol calls vs ‘rest of calls’
Paracetamol calls (%)
Enquiry type
n=6367
‘Rest of calls’ (%)
n=116 850
Efficacy
Interaction†
Other safety†
Administration
Pregnancy/lactation†
Logistics
Miscellaneous
Missing
22.8
14.8
32.6
11.0
8.3
5.8
4.4
0.3
24.9
21.5
20.6
15.5
13.7
3.3
0.5
0
p Value*
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
Paracetamol calls by age groups (years) (n=6367)
Enquiry type
<1 (%)
1–4 (%)
5–24 (%)
25–44 (%)
45–64 (%)
65+ (%)
Efficacy
Interaction
Other safety
Administration
Pregnancy/lactation
Logistics
Miscellaneous
19.6
29.3
15.3
24.6
8.3
2.9
0
17.7
22.2
17.2
9.0
31.6
1.7
0.6
31.9
21.7
27.4
13.8
0.2
4.3
0.6
31.3
20.0
27.7
14.7
0.4
5.4
0.5
15.8
10.5
9.3
17.5
45.3
1.5
0.2
24.1
28.2
9.5
29.4
7.9
0.7
0.2
*All statistical comparisons between paracetamol-related calls and ‘rest of calls’ used χ2 analyses.
†Enquiry types related to safety.
4
Lau SM, et al. BMJ Open 2016;6:e010860. doi:10.1136/bmjopen-2015-010860
BMJ Open: first published as 10.1136/bmjopen-2015-010860 on 8 June 2016. Downloaded from http://bmjopen.bmj.com/ on June 5, 2020 by guest. Protected by copyright.
Table 2 Top three Anatomical Therapeutic Chemical (ATC) third levels included in paracetamol calls by age group
Open Access
Administration calls
For the 582 administration enquiries, 22 themes were
identified. They could be broadly grouped as enquiries
relating to dose (37.6%, n=219), therapeutic strategy
(21.2%, n=124), medicine constituents (10.1%, n=59)
and safety concerns (9.6%, n=56), with the remainder
not targeting paracetamol as the primary medicine or
addressing issues such as pharmacokinetics. Common
dose-related questions asked across all age groups were
the appropriate amount or volume (45.7% of dose questions, n=100) (What dose can I give of Panadol for my son?)
and a safety check of a proposed dose (14.2%, n=31) (Is
it okay to take 4–6 tablets of paracetamol per day?).
Two age-specific themes in the <1 year group were
related to therapeutic strategy, specifically where callers
sought to achieve the best therapeutic outcome. First,
callers sought to verify the appropriateness of administration in a specific setting, usually for a specified age
(Can I give children’s Panadol to my 10-month-old baby?) or
indication (Can I give children’s Panadol 500 mg tablets for
fever to my 3 years old?). Second, management of redosing
paracetamol after vomiting or diarrhoea was a common
concern (Can I give my child another dose of Panadol if she
immediately vomited it up after I administered it?). These two
themes were replicated in the 1–4 age group. In addition, callers for those aged 1–4 asked about paracetamol
Lau SM, et al. BMJ Open 2016;6:e010860. doi:10.1136/bmjopen-2015-010860
administration with food or drink (Can Painstop be given
with juice?) and the action to take or outcomes after an
unintentional overdose (My 1 year old has swallowed at
least 1/2 a paracetamol tablet—will she be okay?).
Age-specific themes identified for patients aged 5–
24 years were largely dose related. These included dose
calculation (Should you dose paracetamol by weight or age in
children?), verifying dose timing (Is it okay to give my
5-year-old 9.5 mL of Panadol syrup every 4 hours for a fever?)
and repeating a dose (Can I repeat the dose of Panadol from
my child’s fever after the last dose 5 hours ago?). As for the
0–4 age group, outcome after an unintentional overdose
was also a common theme (Have I given too much Painstop
to my 10-year-old child?).
In the 25–44 age group, use of multiple paracetamolcontaining medicines was a focus (Can I take Mersyndol
1 hour after taking 1000 mg of Panamax?). In contrast,
callers aged 45–64 were interested in alternative analgesic options (Is it okay to take Panadeine Forte instead of
Endone?) and medicine constituents, whether excipient
or active (Can you tell me the gluten content for Panamax,
Tramal and Mobic?).
Several age-specific themes were identified in the 65+
group. Medicine constituent questions predominated,
with callers commonly asking for a direct comparison
between medicines (What is the difference between Panadol
and Panadol Osteo?). Enquiries about the maximum permissible dose were prevalent (What is the maximum dose of
paracetamol that I can take for osteoarthritis pain?). The concomitant use of a second paracetamol medicine was
another common theme, as with the 25–44 age group.
The final theme related to safety, where callers had a
specific health concern about paracetamol (Will taking
four paracetamol a day harm my liver?).
Pregnancy/lactation calls
There were broadly two types of questions related to
paracetamol in pregnancy or breast feeding. Callers,
usually the patient themselves, were either seeking
reassurance of safety after exposure to paracetamol (Will
it matter if I have taken Di-Gesic while breast feeding?) or
trying to minimise risk prior to medicine exposure. Risk
aversion questions included safety of use at a particular
gestation or while breast feeding (Can I take paracetamol
if I am [a specified number of weeks] pregnant/breast
feeding?) or seeking to quantify medication risk (What are
the effects of paracetamol on my baby when breast feeding?).
DISCUSSION
We found that consumers have many unanswered questions about paracetamol. The nature of their concerns
varied with patient age or life stage. Safety was the major
area of enquiry across ages, with interest in interaction
and side effect risk increasing with age. Effectiveness of
the medicine was an issue for all, but especially for preschool children and older adults. Pregnancy or lactation
questions focused on minimising paracetamol risk prior
5
BMJ Open: first published as 10.1136/bmjopen-2015-010860 on 8 June 2016. Downloaded from http://bmjopen.bmj.com/ on June 5, 2020 by guest. Protected by copyright.
n=55). The remainder did not primarily address paracetamol interactions. Across all age groups, the most
common objective was minimising medication risk,
asking about the safety of prospectively administering
paracetamol with another medicine (Can I take Panadol
with Mobic?). This comprised 73.6% of all interaction
enquiries (n=659). Another question common to all age
groups was whether paracetamol could be used shortly
after taking another medicine (Can I take paracetamol if I
had tramadol 50 mg 6 hours ago?) (6.9%, n=62). While
there was no specific theme identified for patients
<1 year, callers for the 1–4-year group were concerned
about combining medicines prior to administration
(Can I combine Dimetapp Elixir and Panadol to give to my
two year old?). Calls for patients aged 5–24 concerned
potential interactions with lifestyle products, such as
alcohol or supplements (Can I drink alcohol after taking
Phenergan and Panadol?). For groups aged 25–44, 45–64
and 65+, a common theme was the appropriate choice
of medicine for a particular purpose, based on current
medication (What analgesics are safe to take with Zoloft and
Xanax?). Finally, both the 25–44 and 65+ groups asked
about the potential for a worrying symptom being
caused by a medicine interaction (Could paracetamol and
esomeprazole have caused stomach cramps?).
When interaction calls were further categorised,
enquiries directed towards a specific indication comprised the majority in the <1 and 1–4 age groups
(59.0–64.6%). For all other age groups, calls sourcing
information on potential interactions for a medicines
list, including paracetamol, dominated.
Open Access
6
stage. Improving these aspects for paracetamol should
be a focus of future research.
While written information is available to varying standards in the UK and Australia, medical professionals
remain the most trusted information source.33
Consumers are, however, unlikely to consult their
general practitioner about OTC medicine use.34
Furthermore, research shows that healthcare professionals tend to drive and dominate communication
about medicines in consultations, rendering it critical
for deficiencies in patient knowledge to be brought to
the forefront of health professional awareness.35
Pharmacists may therefore play a pivotal role in providing information as the first and potentially only
face-to-face contact.36 Australian research has shown that
the majority of OTC medicines for children are still
sourced from pharmacies rather than supermarkets,33
with many considering pharmacists medicines experts
and preferring spoken over written information.37
Consideration could also be given to changing the OTC
status to pharmacist-only or prescription status, as has
been called for in research and the media.38 39
Medicines most commonly enquired about in combination with paracetamol were analgesics, especially
codeine and ibuprofen, despite concomitant use in
adults being safe and effective for additive analgesia at
recommended doses.40 41 The differing caller and question profile for concurrent analgesia involving paracetamol is important for clinicians to know. Health
professionals should also be aware that parents are concerned about interactions between the various medicines,
including paracetamol, antihistamines and ibuprofen.
While both the UK and Australian written medicines
information contain limited details about medicines with
potential for interactions;25 27 consideration to include a
similar list of safe medications would provide reassurance
where there is common concurrent use.
This study has several strengths. A large number of
calls made to Medicines Line were available over eight
consecutive years. Paracetamol call distribution
approached relative population frequency. The data also
permitted both quantitative and narrative analysis, giving
detailed insight into consumer concerns. Age groups
were well represented in the enquiry type subsets for
interaction and administration, so they can be considered a representative sample for thematic analysis by
age. Limitations include sampling bias; people who
contact medicines call centres may have different information needs from the wider population. This study
highlighted those consumers who had sufficient concerns about paracetamol use to seek information, but
fails to capture the reverse—consumers who assume that
paracetamol is safe due to its OTC status.42 The calls are
also from an Australian population and may not accurately reflect concerns held by consumers in other
countries.
Consumers have many concerns about paracetamol
use that are likely to be under-recognised by healthcare
Lau SM, et al. BMJ Open 2016;6:e010860. doi:10.1136/bmjopen-2015-010860
BMJ Open: first published as 10.1136/bmjopen-2015-010860 on 8 June 2016. Downloaded from http://bmjopen.bmj.com/ on June 5, 2020 by guest. Protected by copyright.
to maternal, fetal or infant exposure or seeking a risk
management strategy after inadvertent exposure, while
administration was an issue in young patients where
dosing can be difficult.
Previous research has investigated patient, carer and/
or health professional knowledge and attitudes about
the use (dosing and unintentional risks) of paracetamol.21–23 These studies identified paracetamol knowledge gaps for many consumers, as well as healthcare
providers having varied knowledge of appropriate use.
However, it was difficult to identify a question pattern
about paracetamol use from these publications due to
diversity in study design. Participants were commonly
recruited from a general practice waiting room where
they generally responded to questions constructed by
the investigators. This is not the same sample frame as
our database of spontaneous calls. In general, misinformation about risks was a recurring theme; and this is
what our paper also shows. While ‘greater education of
health care workers is required in order to provide families with appropriate information’23 was recommended,
little research has addressed health professional
responses to the information gaps consumers have
about paracetamol. Generally, healthcare providers
underestimate consumer concerns about medication
risk24–26 and do not adequately acknowledge these concerns.25 27 28 This mismatch was also highlighted in the
recent BMJ editorial2 that addressed only three broad
questions as important to paracetamol consumers (efficacy, adverse effects and dose). Our study provides the
consumer perspective to this issue.
The primary prompt for paracetamol calls was inadequate information, which highlights the lack of information provided with OTC medicines. In the UK,
general sales list medicines,29 which are freely available
in supermarkets, thus come without advice from health
professionals. Mandatory information supplied with
OTC
medicines
varies
between
countries.
Pharmaceutical companies in the UK must supply
approved Patient Information Leaflets with all medicines
unless all necessary information specified by the
Medicines and Healthcare products Regulatory Agency
(including indications, contraindications, general dosing
instructions and side effects) is included on the label.30
The electronic Medicines Compendium,31 targeted at
health professionals, provides additional Summaries of
Product Characteristics. The equivalent Australian documents are CMI leaflets and Product Information,
neither of which is mandatory for OTC medicines. Aside
from Panamax,32 there are no accessible CMI for
common paracetamol-only formulations. Importantly,
none of these consumer resources provide strategies to
prevent or reduce risk from common occurrences such
as redosing after vomiting or reassurance, where appropriate, when planned or inadvertent exposure to paracetamol occurs. Addressing consumer OTC medicine
concerns requires information in CMI (or equivalent) to
be comprehensible and actionable, targeted for life
Open Access
Acknowledgements The authors would like to acknowledge NPS
MedicineWise (formerly National Prescribing Service, Australia), funder of
NPS Medicines Line and service provider since July 2010. They would also
like to thank Mater Health Services for providing the raw service data from
September 2002 to 30 June 2010.
Contributors TMM and MLvD provided supervision, and conceived and
designed the study. SML conducted the literature review and data analysis.
SML, TMM and MLvD interpreted the data, and drafted and critically revised
the manuscript. SML, TMM and MLvD as guarantors accept full responsibility
for the work and/or the conduct of the study; they had access to the data and
controlled the decision to publish.
Funding This research received no specific grant from any funding agency in
the public, commercial or not-for-profit sector.
Competing interests None declared.
Ethics approval This study was approved by Mater Health Services Brisbane,
Human Research Ethics Committee (LNR submission 2012-68) and University
of Queensland School of Medicine Low Risk Ethical Review Committee
(2014-SOMILRE-0098).
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
Open Access This is an Open Access article distributed in accordance with
the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license,
which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided
the original work is properly cited and the use is non-commercial. See: http://
creativecommons.org/licenses/by-nc/4.0/
21.
22.
23.
24.
REFERENCES
1.
2.
3.
4.
5.
6.
7.
Sood S, Howell J, Sundararajan V, et al. Paracetamol overdose in
Victoria remains a significant health-care burden. J Gastroenterol
Hepatol 2013;28:1356–60.
Dear JW, Antoine DJ, Park BK. Where are we now with
paracetamol? BMJ 2015;351:h3705.
Daly FFS, O’Malley GF, Heard K, et al. Prospective evaluation of
repeated supratherapeutic acetaminophen ( paracetamol) ingestion.
Ann Emerg Med 2004;44:393–8.
McGill MR, Jaeschke H. Metabolism and disposition of
acetaminophen: recent advances in relation to hepatotoxicity and
diagnosis. Pharm Res 2013;30:2174–87.
Office for National Statistics. Deaths related to drug poisoning in
England and Wales, 2014 registrations. Newport: Office for National
Statistics, 2015 (cited 31 October 2015). http://www.ons.gov.uk/ons/
dcp171778_414574.pdf
Australian Institute of Health and Welfare. Drugs in Australia 2010:
tobacco, alcohol and other drugs. Canberra: Australian Institute of
Health and Welfare, 2011 (cited 15 September 2015). http://www.
aihw.gov.au/WorkArea/DownloadAsset.aspx?id=10737420455
Australian Bureau of Statistics. Deaths collection: drug related
deaths by type of drug (total drug related deaths). Canberra:
Commonwealth of Australia, 2007 (cited 31 October 2015).
Lau SM, et al. BMJ Open 2016;6:e010860. doi:10.1136/bmjopen-2015-010860
25.
26.
27.
28.
29.
30.
31.
http://www.drugfree.org.au/fileadmin/Media/Reference/DFA_
DrugRelatedStats.pdf
Holappa M, Ahonen R, Vainio K, et al. Information sources used by
parents to learn about medications they are giving their children. Res
Social Adm Pharm 2012;8:579–84.
Hämeen-Anttila K, Nordeng H, Kokki E, et al. Multiple information
sources and consequences of conflicting information about medicine
use during pregnancy: a multinational internet-based survey. J Med
Internet Res 2014;16:e60.
Grymonpre RE, Steele JW. The medication information line for the
elderly: an 8-year cumulative analysis. Ann Pharmacother
1998;32:743–8.
Khoo K, Bolt P, Babl FE, et al. Health information seeking by
parents in the internet age. J Paediatr Child Health 2008;44:
419–23.
Gatti A, Sabato E, Di Paolo AR, et al. Oxycodone/paracetamol:
a low-dose synergic combination useful in different types of pain.
Clin Drug Investig 2010;30(Suppl 2):3–14.
National Prescribing Service Limited. Medicines Line. Sydney:
National Prescribing Service, 2012 (cited 28 July 2015). http://www.
nps.org.au/contact-us/medicines-line
Pohjanoksa-Mäntylä MK, Antila J, Eerikäinen S, et al. Utilization
of a community pharmacy-operated national drug information call
center in Finland. Res Soc Adm Pharm 2008;4:144–52.
Marvin V, Park C, Vaughan L, et al. Phone calls to a hospital
medicines information helpline: analysis of queries from members
of the public and assessment of potential for harm from their
medicines. Int J Pharm Pract 2011;19:115–22.
Government of Ontario. Telehealth Ontario. Ontario: Government
of Ontario, 2015 (cited 28 July 2015). https://www.ontario.ca/page/
get-medical-advice-telehealth-ontario
Benchimol EI, Smeeth L, Guttmann A, et al. The REporting of
studies Conducted using Observational Routinely-collected health
Data (RECORD) Statement. PLoS Med 2015;12:e1001885.
von Elm E, Altman DG, Egger M, et al. Strengthening the Reporting
of Observational Studies in Epidemiology (STROBE) statement:
guidelines for reporting observational studies. BMJ 2007;335:806–8.
WHO Collaborating Centre for Drug Statistics Methodology.
Guidelines for ATC classification and DDD assignment, 2015. Oslo:
Norwegian Institute of Public Health, 2014 (cited 31 October 2015).
http://www.whocc.no/filearchive/publications/2015_guidelines.pdf
Australian Bureau of Statistics. Families in regional, rural and remote
Australia 2006 Census Data. Canberra: Australian Government,
2010 (cited 3 November 2015). http://www.abs.gov.au/AUSSTATS/
abs@.nsf/Lookup/1379.0.55.001Explanatory%20Notes12002-2006?
OpenDocument.
Wolf MS, King J, Jacobson K, et al. Risk of unintentional overdose
with non-prescription acetaminophen products. J Gen Intern Med
2012;27:1587–93.
Herndon CM, Dankenbring DM. Patient perception and knowledge
of acetaminophen in a large family medicine service. J Pain Palliat
Care Pharmacother 2014;28:109–16.
Karwowska A, Nijssen-Jordan C, Johnson D, et al. Parental and
health care provider understanding of childhood fever: a Canadian
perspective. CJEM 2002;4:394–400.
DeWitt JE, Sorofman BA. A model for understanding patient
attribution of adverse drug reaction symptoms. Drug Inf J
1999;33:907–20.
Britten N. Medication errors: the role of the patient. Br J Clin
Pharmacol 2009;67:646–50.
Knapp P, Gardner PH, Carrigan N, et al. Perceived risk of medicine
side effects in users of a patient information website: a study of the
use of verbal descriptors, percentages and natural frequencies.
Br J Health Psychol 2009;14:579–94.
Berry DC, Michas IC, Gillie T, et al. What do patients want to know
about their medicines and what do doctors want to tell them?
A comparative study. Psychol Health 1997;12:467–80.
Hoffmann TC, Del Mar C. Patients’ expectations of the benefits and
harms of treatments, screening, and tests: a systematic review.
JAMA Intern Med 2015;175:274–86.
National Health Service Choices. Medicines Information. London:
National Health Service, 2014 (cited 31 October 2015). http://www.
nhs.uk/conditions/Medicinesinfo/Pages/Introduction.aspx
Medical and Healthcare Products Regulatory Agency. Best practice
guidance on the labelling and packaging of medicines. London:
Government of the United Kingdom, 2014 (cited 31 October 2015)
https://www.gov.uk/government/publications/
best-practice-in-the-labelling-and-packaging-of-medicines.
Electronic Medicines Compendium. About the eMC. Leatherhead,
UK: Datapharm, 2015(cited 31 October 2015). http://www.medicines.
org.uk/emc/about-the-emc
7
BMJ Open: first published as 10.1136/bmjopen-2015-010860 on 8 June 2016. Downloaded from http://bmjopen.bmj.com/ on June 5, 2020 by guest. Protected by copyright.
providers, with different patient age groups and life
stages having unique questions that should be considered when targeting information towards patients.
Therapeutic strategies to minimise paracetamol risk are
not adequately addressed by available information.
Improving information may be challenging due to the
OTC status of paracetamol and the diversity of commercial brands. Strategies such as increasing pharmacist
involvement with paracetamol supply may be useful, but
may necessitate a change in its unrestricted availability
in other places such as supermarkets. Ultimately, the
accessibility of information that the public wants to know
needs to be targeted to optimise the safe and effective
use of paracetamol.
Open Access
32.
34.
35.
36.
8
37.
38.
39.
40.
41.
42.
Hamrosi K, Raynor D, Aslani P. Enhancing provision of written
medicine information in Australia: pharmacist, general practitioner
and consumer perceptions of the barriers and facilitators. BMC
Health Serv Res 2014;14:183.
Jó
zwiak-Bebenista M, Nowak JZ. Paracetamol: mechanism of action,
applications and safety concern. Acta Pol Pharm 2014;71:11–23.
Collins N. Paracetamol ‘should be prescription-only’. London: The
Telegraph, 2012 (cited 14 July 2014). http://www.telegraph.co.uk/
news/uknews/9134065/Paracetamol-should-be-prescription-only.html
Merry AF, Gibbs RD, Edwards J, et al. Combined acetaminophen
and ibuprofen for pain relief after oral surgery in adults: a
randomized controlled trial. Br J Anaesth 2010;104:80–8.
Barkin RL. Acetaminophen, aspirin, or ibuprofen in combination
analgesic products. Am J Ther 2001;8:433–42.
Bennin F, Rother HA. “But it’s just paracetamol”: Caregivers’ ability
to administer over-the-counter painkillers to children with the
information provided. Patient Educ Couns 2015;98:331–7.
Lau SM, et al. BMJ Open 2016;6:e010860. doi:10.1136/bmjopen-2015-010860
BMJ Open: first published as 10.1136/bmjopen-2015-010860 on 8 June 2016. Downloaded from http://bmjopen.bmj.com/ on June 5, 2020 by guest. Protected by copyright.
33.
Sanofi. Panamax: Consumer Medicines Information. Sydney: Sanofi,
2014 (cited 8 September 2015). http://www.sanofi.com.au/products/
aus_cmi_panamax.pdf
Hesse BW, Nelson DE, Kreps GL, et al. Trust and sources of health
information: the impact of the internet and its implications for health
care providers: findings from the first health information national
trends survey. Arch Intern Med 2005;165:2618–24.
Sleath B, Rubin RH, Campbell W, et al. Physician-patient
communication about over-the-counter medications. Soc Sci Med
2001;53:357–69.
Stevenson FA, Cox K, Britten N, et al. A systematic review of the
research on communication between patients and health care
professionals about medicines: the consequences for concordance.
Health Expect 2004;7:235–45.
Simoens S, Lobeau M, Verbeke K, et al. Patient experiences of
over-the-counter medicine purchases in Flemish community
pharmacies. Pharm World Sci 2009;31:450–7.