GENERAL PUBLIC HEALTH
Consumer knowledge about over-the-counter
NSAIDs: they don’t know what they don’t know
Judy Mullan,1 Kathryn M. Weston,1 Andrew Bonney,1 Pippa Burns,1 John Mullan,2 Rima Rudd3
N
on-steroidal anti-inflammatory
drugs (NSAIDs) are among the
most common medications used to
treat acute pain associated with a variety of
conditions, such as headache, muscle injury,
dental pain, sore throat and dysmenorrhea.1
They are also used to treat chronic pain or
inflammation associated with long-term
conditions, such as rheumatoid arthritis and
osteoarthritis.2 NSAIDs are available without
a prescription as over-the-counter (OTC)
products in many countries, which may have
contributed, in part, to the increase in the
consumption of NSAIDs over the past 20
years.3-7 Estimates suggest that analgesic
medicine sales are a significant proportion
of the non-prescription market (8.5% in
Australia; 14% in Europe and 16.5% in the
United States [US]).8 This ready availability
of NSAIDs may also have resulted in an
increased incidence of drug-related morbidity
among people, and especially among older
adults, with pre-existing gastrointestinal,
cardiovascular and renal complications.2,9,10
Ibuprofen is the most widely purchased
and used OTC NSAID both in the US11 and
Australia.8 In Australia, ibuprofen 200 mg has
been available for purchase in pharmacies
as an OTC product since 1989, and in 2004 it
was re-scheduled to a ‘general sales’ status.8
This means that ibuprofen 200 mg can be
purchased in pharmacies and from general
retail outlets (e.g. supermarkets, convenience
stores and service stations) and is not
included in any of the Australian poisons
standard schedules.12 These changes are
more convenient for patients self-managing
their pain.4 However, if taken inappropriately
and over long periods, ibuprofen can cause
gastro-intestinal,13,14 renal,15 and cardiac16,17
1. School of Medicine, University of Wollongong, New South Wales
2. Community Pharmacist, New South Wales
3. Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Harvard University, US
Correspondence to: Dr Judy Mullan, School of Medicine, University of Wollongong, Northfields Ave, Wollongong, NSW 2522; e-mail: jmullan@uow.edu.au
Submitted: January 2016; Revision requested: May 2016; Accepted: June 2016
The authors have stated they have no conflict of interest.
210
Abstract
Objective: To investigate consumers’ knowledge about commonly purchased over-the-counter
(OTC) products containing ibuprofen.
Methods: Customers buying two popular OTC ibuprofen-containing products (Nurofen or
Nurofen Plus) were asked to complete a short survey assessing their knowledge about the
products.
Results: The survey was completed by 262 respondents, most of whom were older than 50 years
of age; female; well-educated; with adequate functional health literacy. The majority correctly
identified ibuprofen as an active ingredient and knew the correct intervals between doses.
However, almost a third couldn’t correctly identify the maximum daily dose and were unaware
of some contraindications. Furthermore, fewer than half recognised potential side effects. Those
who hadn’t completed high school were significantly less likely to seek medical advice (when
required) and significantly less likely to know when it was safe to take these products.
Conclusions: The gaps in consumer knowledge, especially about the maximum daily dose,
contraindications and potential side effects may be placing consumers at risk of experiencing
ibuprofen-related adverse events.
Implications for public health: Improving consumer knowledge to address these gaps in
their understanding about the safe use of popular OTC ibuprofen-containing products is an
important public health concern.
Key words: Over-the-counter NSAIDs, health literacy, Ibuprofen, consumer knowledge, adverse
drug events
complications, especially among the ‘at risk’ more than half of Australian adults (59%), had
patient groups.2,7,9,10 A previous Australian difficulty locating information on a bottle
study found that since becoming a ‘general of medicine and to identify the maximum
sales’ item, ibuprofen sales had increased, number of days to take the medicine.20
and so too had the number of patients Consequently, it is reasonable to suggest
inappropriately using ibuprofen.8 that many Australians buying OTC NSAID
products may not be able to understand
Factors that may contribute to the
the information printed on the side of the
inappropriate use of OTC analgesics and
packaging addressing appropriate use,
poor self-management include inadequate
beneficial or adverse effects.
health literacy18,19 and consumers’ inability
to find and/or understand product labelling The limited research in this area, along
on different medicines.8 The 2006 Australian with the increasing use of OTC ibuprofen,
Adult Literacy and Life Skills Survey (ALLS) prompted this investigation into consumer
found that a large proportion of the understanding of the information available
population had limitations in their ability to on the side of the packaging of regularly
use information related to medicine and that purchased OTC NSAID products. More
Aust NZ J Public Health. 2017; 41:210-4; doi: 10.1111/1753-6405.12589
Australian and New Zealand Journal of Public Health 2017 vol. 41 no. 2
© 2016 Public Health Association of Australia
General Public Health
specifically, the aim of this study was to
investigate consumers’ knowledge about the
active ingredient, the dosage requirements,
potential side effects and contraindications
associated with two popular OTC ibuprofen
containing products (Nurofen™ and
Nurofen Plus™). The study also investigated
whether consumers’ product knowledge
was associated with their functional health
literacy and/or their levels of education.
Methods
Following ethics approval from the University
of Wollongong Human Research Ethics
committee, seven Australian community
pharmacies were recruited to take part in the
study between January and August 2013.
The pharmacies were across the New South
Wales South Coast region in an attempt to
recruit respondents from different socio-
demographic backgrounds.
Consumers, aged 18 years and over, who
bought Nurofen or Nurofen Plus (a
popular and frequently advertised brand
of ibuprofen) during the study period were
invited to take part in the study by one of two
research assistants (AM or JM). Individuals
who did not read English and those who were
unable to complete the survey unassisted
were excluded from the study.
Volunteering respondents were asked to
complete a 10-minute paper-based survey
at the point-of-purchase of either Nurofen
or Nurofen Plus. Completed surveys
were deposited in a sealed box. The survey
included demographic questions (age,
gender and education) and the adequacy
of their functional health literacy was
determined by using the validated single
item literacy screener (SILS).21 Respondents
with scores of 1: never or 2: rarely (‘need
help reading instructions’) were deemed
to have adequate functional health literacy
scores, while those who responded with 3:
sometimes, 4: often or 5: always were deemed
to have inadequate functional health literacy
scores. This cut-off point is the same as that
used by Morris et al. (2006).21
The survey also included several other
questions developed by the authors. Survey
respondents were informed that the correct
answers to these questions, were available
on the outside of the Nurofen and Nurofen
Plus product packaging.
(a) Which ingredient is in this medicine?
2017 vol. 41 no. 2
Consumer knowledge about over-the-counter NSAIDs
Multiple-choice options were: Aspirin;
Glucosamine; Ibuprofen; Paracetamol.
(b) What is the maximum amount of this
medicine that an adult can take in one day
(24 hours)? Multiple-choice options: 2 tablets;
4 tablets; 6 tablets; 8 tablets; 10 or more
tablets.
(c) If you took two of these tablets at 8 am,
when is the earliest time that you can take
more of these tables on the same day?
Multiple choice options: 2-3 hours later
(between 10am and 11am); 4 hours later (12
noon); and 5-6 hours later (between 1pm and
2pm).
(d) When should you seek medical advice
before taking this medicine? Yes or no
responses were required for each of the
following options: If you suffer from asthma;
If you have a history of kidney disease; If you
are taking medicine that thins the blood
e.g. warfarin; If you are on medicine for high
blood pressure or heart problems; and If you
have a sleeping disorder.
(e) Is it safe to take this medicine? Yes or
no responses were required for each of
the following options: If you have kidney
problems; If you have high blood pressure
or heart problems; If you have asthma; and If
you have a sleeping disorder.
(f) Can you take this medicine? Yes or no
responses were required for each of the
following options: If you are allergic to
ibuprofen; If you are allergic to aspirin; and If
you are allergic to milk products.
(g) Which of the following are possible
side effects of this medicine? Respondents
were asked to tick the correct answers from
the following options: arthritis; coughing,
kidney disease; ringing in the ears; stomach
problems; and no side effects.
SPSS Statistics for Windows version 21 was
used to analyse the data. The generalised
estimating equation procedure was used to
fit binary logistic regression models with the
respondent’s pharmacy included as a subject
variable to control for the clustered nature
of the data. Univariate regression models for
respondents’ age and gender were tested
with ‘When should you seek medical advice
before taking this medicine?’ as the outcome
variable. Controlling for age and gender,
models were then fitted with the respondents’
education level and functional health literacy
scores as the predictor variables, with ‘When
should you seek medical advice before taking
this medicine?’ and ‘Is it safe to take this
Australian and New Zealand Journal of Public Health
© 2016 Public Health Association of Australia
medicine?’ as the outcome variables. Since
respondents may not have known the correct
response to an item but still acted safely
by not consuming the medication before
seeking medical advice, the ‘When should
you seek medical advice before taking this
medicine?’ responses were chosen as the
primary measure of consumers’ knowledge
of safe medication behaviour. The ‘Is it safe
to take this medicine?’ responses were
considered to reflect the consumers’ personal
knowledge of potential harms of the OTC
products and were analysed as a secondary
outcome. Responses to items in the following
domains ‘When should you seek medical
advice before taking this medicine?’ or ‘Is it
safe to take this medicine?’ were collapsed
into binary variables; with either ‘all responses
correct’ or ‘any response incorrect’ for each
domain.
Results
Demographic information and health
literacy levels of respondents
In total, 262 respondents completed the
survey (Table 1), 68.7% of whom were female.
The largest age-group were aged between
50 and 69 years (34%) with a median age of
48 years. The study sample was well educated
with more than 70% of respondents having
completed high school; Technical and Further
Education (TAFE) and/or college/university. It
is therefore not surprising that the majority of
respondents had adequate functional health
literacy scores (94.3%) (Table 1).
Table 1: Demographic information of study
respondents.
Number of
responses
n=262 (%)
Gender (n=260 responses)
Female 180 (68.7%)
Male 80 (30.5%)
Age range (years)(n=260 responses)
18-33 years of age (born 1982–2000) 60 (22.9%)
34-49 years of age (born 1966–1981) 77 (29.4%)
50-69 years of age (born 1946–1965) 89 (34.0%)
70-90 years of age (born 1925–1945) 34 (13.0%)
Education level (n= 261 responses)
Did not complete high school 74 (28.2%)
Completed high school or Technical and 107 (40.8%)
Further Education (TAFE)
Completed College or University 80 (30.5%)
Health Literacy Level (n=262 responses)
Adequate 247 (94.3%)
Inadequate 15 (5.7%)
211
Mullan et al. Article

Knowledge about active ingredient, did not answer the question or mistakenly Knowledge of potential side effects
maximum daily dosage and shortest believed that the shortest interval between When asked to indicate which of the
dosage interval doses was between two and three hours. options provided were potential side effects
The majority of the respondents (80.5%) associated with taking these OTC products
Knowledge about when to seek fewer than half the respondents correctly
correctly identified ibuprofen as being an
active ingredient in Nurofen and Nurofen medical advice and contraindications recognised that kidney disease (43.5%;
Plus (Table 2). However, since a number Well over two-thirds of the respondents n=114) was a side effect and that ringing
of them ticked more than one option for recognised that they needed to seek medical in the ears could also be a problem (11.5%;
this question, just under a third incorrectly advice before taking the OTC products if n=30). More respondents knew that stomach
identified additional ingredients, such as they suffered from asthma (71.4%); kidney problems (58.4%; n=153) were possible side
paracetamol (19.5%) and aspirin (11.5%) as disease (66.8%); blood pressure/heart disease effects, while only a few incorrectly believed
being available in these OTC products (Table (73.7%); or if they were taking blood thinning that arthritis (4.2%, n=11) and coughing
2). medications (67.6%)(Table 3). Notably (10.7%, n=28) were possible side effects. Just
however, at least a quarter of the study over a fifth of the study sample (21.8%; n=57)
Nearly two-thirds of the respondents (64.5%)
sample incorrectly answered these questions believed that no side effects were associated
correctly recognised that a maximum of six
or simply provided no responses (Table 3). with taking these OTC products.
tablets could be taken in a 24-hour period
(Table 2). While the remaining one-third In addition, over a third of the respondents
incorrectly indicated that either a larger daily incorrectly believed that they required Logistic regression results
dose of up to 8–10 tablets could be safely medical advice (39.3%) before taking the Of the responses received, most respondents
consumed (18.7%), or that no more than medications (Table 3). made at least one incorrect response to
four tablets could be taken within a 24-hour Even though the majority of the respondents the question asking ‘When should you seek
period (12.5%)(Table 2). recognised that it was not safe to take the medical advice before taking this medicine?’
OTC products if they suffered from kidney (85.5%; n=153) and ‘When is it safe to take
The majority of the respondents correctly
disease (74.0%) or if they had an ibuprofen this medicine?’ (86.8%; n=165). Neither
indicated that a minimum period of four
allergy (87.8%), a considerable number age nor gender of the respondents was
hours was required between doses of these
incorrectly thought that it was safe to take the significantly associated with the responses
OTC products (70.2%)(Table 2). Notably
products if they suffered from asthma (27.1%) tested. However, with ‘completed university’
however, as many as 17 respondents (10.3%)
or high blood pressure/heart problems as the referent category, lower education
(21.4%)(Table 3). Many of the study sample attainment (‘did not complete high school’)
Table 2: Participant responses to product incorrectly believed that it was not safe to was significantly associated with respondents
information questions. take the products if they had a sleeping making incorrect responses in both the
Number of Percentage disorder (36.6%) or a milk allergy (26.3%), and ‘When should you seek medical advice before
Participant of Participant just under a third of them (30.2%) did not taking this medicine’ (OR 2.56; 95% CI 1.15-
Responses Responses recognise that an allergy to aspirin was also a 5.73; p=0.022) and ‘When is it safe to take
(a) What ingredients are in this medicine? (note: several contraindication (Table 3). this medicine?’ (OR 5.62; 95% CI 2.06-15.32;
participants ticked more than one active ingredient for
p=0.001). Inadequate functional health
this question)
literacy was not associated with respondents
Aspirin 30 11.5%
making incorrect responses for either these
Glucosamine 6 2.3%
questions.
Ibuprofen (correct 211 80.5%
response)
Paracetamol 51 19.5%
Table 3: Responses to the following yes/no questions.
(b) What is the maximum amount of this medicine that
Correct Responses Incorrect Responses No Responses
an adult can take in one day (24 hours?);
n (%) n (%) n (%)
2 tablets 18 6.9%
When should you seek medical advice before taking this medicine?
4 tablets 15 5.7%
If you suffer from asthma 187 (71.4%) 39 (14.9%) 36 (13.7%)
6 tablets (correct response) 169 64.5%
If you have a history of kidney disease 175 (66.8%) 40 (15.3%) 47 (17.9%)
8 tablets 45 17.2%
If you are taking medicine that thins the blood e.g. warfarin 177 (67.6%) 45 (17.2%) 40 (15.3%)
10 or more tablets 4 1.5%
If you are on medicine for high blood pressure or heart problems 193 (73.7%) 33 (12.6%) 36 (13.7%)
No response 11 4.2%
If you have a sleeping disorder 91 (34.7%) 103 (39.3%) 68 (26.0%)
(c) If you took two of these tablets at 8 am, when is the
Is it safe to take this medicine?
earliest time that you can take more of these tables on
If you have kidney problems 194 (74.0%) 28 (10.7%) 40 (15.3%)
the same day?
If you have blood pressure or heart problems 165 (63%) 56 (21.4%) 41 (15.6%)
2-3 hours later (between 15 5.7%
10am and 11am) If you have asthma 146 (55.7%) 71 (27.1%) 45 (17.2%)
4 hours later (at 12 noon) 184 70.2% If you have a sleeping disorder 106 (40.5%) 96 (36.6%) 60 (22.9%)
(correct response) Can you take this medicine?
5-6 hours later between 51 19.5% If you are allergic to aspirin 162 (61.8%) 79 (30.2%) 21 (8.0%)
(1pm and 2pm) If you are allergic to ibuprofen 230 (87.8%) 14 (5.3%) 18 (6.9%)
No response 12 4.6% If you are allergic to milk products 149 (56.9%) 69 (26.3%) 44 (16.8%)

212 Australian and New Zealand Journal of Public Health 2017 vol. 41 no. 2
© 2016 Public Health Association of Australia
General Public Health
Discussion
Despite the majority of this sample being
well-educated and having adequate
functional health literacy (94%), almost a fifth
of the respondents were unable to identify
ibuprofen as an active ingredient and/or
incorrectly identified paracetamol and aspirin
as active ingredients. In terms of dosing
regimen, just under a third of the sample did
not know the maximum number of tablets
that could be taken in a 24-hour period and
a quarter of the respondents did not know
the shortest possible interval between doses.
For those under-dosing (under-estimating
the daily maximum dose), this could lead
to sub-optimal pain management and
for those over-dosing (over-estimating
the daily maximum dose) it could lead to
complications and adverse drug events.
In the main, at least a quarter of the
respondents gave incorrect or no responses
for indications that require medical advice
before taking the OTC products, and for
health conditions and/or allergies which
are contraindications for the use of these
NSAIDs. Of greater concern, was that less
than 60% of the study sample recognised
that stomach problems were a potential
side effect, and that less than half of the
respondents identified that kidney disease
was another possible side effect. Moreover,
just over a fifth of the study sample (21.5%)
believed that taking these products would
cause no side effects, which is very worrying
given that many of these products are
available from retail outlets where no health
professional advice is available at the point
of purchase. Our study findings support
those of other researchers,22-24 including
Ngo et al (2010) who found that many
people were unaware that ibuprofen could
cause serious adverse effects.25 This gap in
knowledge may predispose consumers to
adverse drug events because many may
inadvertently exceed recommended daily
doses, especially if they have very low health
literacy scores as identified by Kaufman et al
in their paracetamol/acetaminophen study.26
Many may also not recognise potential
contraindications or simply not be aware of
potential side effects, thereby making this a
widespread public health issue.
Even though seven pharmacies from different
socio-demographic areas were recruited,
very few respondents with low functional
health literacy actually took part in the
study. This may help to explain why our
2017 vol. 41 no. 2
Consumer knowledge about over-the-counter NSAIDs
results did not find an association between
inadequate functional health literacy and
a poorer knowledge and understanding
about the safe use of OTC NSAID products,
contrary to the evidence in the literature.27-30
Our study did, however, find that lower
educational attainment was associated
with significantly poorer knowledge of safe
NSAID consumption and potential harms.
This finding concurs with the evidence in
the literature31-33 and suggests that we need
to better target consumers who are poorly
educated when providing information about
the safe and effective use of these products.
We also need to be mindful that information
sources need to be many and varied, given
that these products are easily accessible.
Information sources could include simple and
easy-to-read written information available on
product packaging, the internet and, when
applicable, in the media.
Easy-to-understand verbal communication
is another important strategy that should be
considered by all health professionals. It has
been previously established that increasing
communication between pharmacy staff and
consumers helped to minimise the negative
consequences of limited health literacy34
and improve consumer knowledge about
NSAIDs.35 However, given that these NSAIDs
can be bought outside the pharmacy setting,
it is necessary for all healthcare practitioners
to play a more active role in increasing
consumer knowledge about the potential
harms associated with taking these products.
It may also be worthwhile for policy makers
to revisit whether OTC NSAIDs containing
ibuprofen should only be made available in
pharmacies, where verbal counselling can
be provided, as previously suggested by an
international study.7
This study highlights a need for future
research to investigate how consumer
knowledge about OTC NSAID products
impacts their personal use of these drugs;
with reference to frequency of use, use
of other analgesic agents and interacting
medications. The study findings also suggest
that the information available on the side
of the packets of OTC NSAIDs may need to
be redesigned to become more accessible
and useful for the consumer, especially for
those from low educational backgrounds.
Furthermore, there is a need for research to
investigate whether the information provided
on the side of the pack is suitable for people
with poor functional health literacy. Given the
findings of the current study, it is important
Australian and New Zealand Journal of Public Health
© 2016 Public Health Association of Australia
to acknowledge the need for further
future strategies to help reduce the gaps in
consumer knowledge and understanding
about the safe use OTC NSAIDs.
Limitations
This study is limited in that the self-selected
sample was drawn from seven community
pharmacies in regional New South Wales,
Australia and may have included individuals
buying these NSAID products for the first
time and/or for use by others. The majority
of participants were female (68.7%), which
is consistent with other research regarding
NSAIDs.25,36 The methodology resulted in
the majority of the sample being highly
educated and having adequate functional
health literacy, which is not reflective of the
population as a whole.20 It is worth noting
that those with inadequate health literacy
are more likely to have bigger gaps in their
knowledge of the safe use of NSAIDs, which
in turn could place them at increased risk of
experiencing NSAID-related adverse drug
events and requires further investigation.
The generalisability of these findings are
also limited by the fact that consumers
purchasing these products from other
retail outlets (e.g. supermarkets and service
stations), and consumers from culturally
and linguistically diverse backgrounds were
unable to complete the survey for pragmatic
reasons (it was a paper-based survey, written
in English). Furthermore, by focusing on a
particular brand of ibuprofen products the
generalisability of the current study findings
may be limited and warrants further research
in this area.
Conclusions
This study highlights that many consumers
purchasing OTC NSAIDs have gaps in their
knowledge about how to use these pain
medications safely and effectively, which is
a major public health issue. It is important
therefore, to consider ways in which these
gaps could be reduced by focusing on a
number of strategies, such as improving
product labelling, providing more media
coverage about how to safely manage these
products and by improving communication
about these products between health
care professionals and consumers. This
combination of strategies will help to
reinforce public awareness of the possible
adverse effects associated with taking these
products inappropriately and to heighten
sensitivities about their potential side effects.
213
Mullan et al.
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