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Patient Education and Counseling 87 (2012) 395–401
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Patient Education and Counseling
journal homepage: www.elsevier.com/locate/pateducou
Medication information
Factors that influence Italian consumers’ understanding of over-the-counter
medicines and risk perception
Andrea Calamusa a, Alessandra Di Marzio a, Renza Cristofani b, Paola Arrighetti c, Vincenzo Santaniello c,
Simona Alfani a, Annalaura Carducci a,*
a
b
c
Health Communication Observatory, Department of Biology, University of Pisa, Italy
Medical Statistics Unit, School of Medicine, University of Pisa, Italy
COOP Italia, Italy
A R T I C L E I N F O
A B S T R A C T
Article history:
Received 27 April 2011
Received in revised form 11 October 2011
Accepted 22 October 2011
Objective: To evaluate information needs for safe self-medication we explored the Italian consumers’
functional health literacy, specific knowledge and risk awareness about over-the-counter (OTC)
medicines.
Methods: A survey was conducted in the health sections of six large super stores. Data were collected
from a convenience sample of 1.206 adults aged 18 years and older through a self-administered
questionnaire.
Results: Around 42% confused the concept of ‘‘contraindications’’ with that of ‘‘side effects’’ and were
unable to calculate simple dosages. Most respondents were aware of the OTC general potential for side
effects but 64.3% did not know that people with high blood pressure should use painkillers with cautions
and 14.0% and 20.0% were unaware of the risks of long-term use of laxatives and nasal decongestants
respectively. Higher total scores were obtained from women, highly educated people and those citing
package leaflets as information sources.
Conclusion: The study, the first of this type in Italy, showed an incomplete awareness of several risk
areas, with regard to drug interactions and misuse/abuse.
Practice implications: The results of this study were the basis of a following intervention plan tailored to the
observed consumer needs and including information tools for customers and courses for the retail
pharmacists.
ß 2011 Elsevier Ireland Ltd. All rights reserved.
Keywords:
Non-prescription medicines
OTC drugs
Health literacy
Knowledge
Risk awareness
Information needs
1. Introduction
Self-medication is becoming increasingly important, because it
offers advantages to healthcare systems in terms of better health
outcomes and resource savings and it also impels people towards
greater independence in making decisions about their health [1].
Effective self-medication requires that people be able to recognize
symptoms and choose the appropriate over-the counter (OTC)
medicine, be aware of potential risks, read and follow the
instructions in Package Information Leaflets (PILs) and know
when to seek the advice of health-care professionals.
The decision process of self-medication depends not only on
individual knowledge, attitudes and practices regarding health,
disease and medication, but also on cultural and social factors. In
particular, advertising in different mass media is a potent source of
* Corresponding author at: Department of Biology, University of Pisa, via S. Zeno,
35/39, 561127 Pisa, Italy. Tel.: +39 050 2213644; fax: +39 050 2213647.
E-mail address: [email protected] (A. Carducci).
0738-3991/$ – see front matter ß 2011 Elsevier Ireland Ltd. All rights reserved.
doi:10.1016/j.pec.2011.10.003
information and influence on the purchase and use of OTC
medicines. Nevertheless doctors and pharmacists still play a leading
role in the self-medication decision-making process, as they are
considered the most trustworthy sources of information [2–5].
Although OTC drugs have a favourable safety profile, the relevant
risks remain a matter of concern because of the widespread use of
these medications. These risks are largely due to some form of
inappropriate use [6–14] and may stem from poor knowledge and
risk perception [15–17].
Of the several factors that may lead to poor knowledge and low
risk awareness regarding self-medication drugs, health literacy can
be considered of particular interest: it is a broad complex concept
which has been defined as ‘‘the capacity to obtain, process and
understand basic health information and services needed to make
appropriate health decisions’’ [18], and is strongly related to
patients’ knowledge, health behaviors, health outcomes and medical
costs [18–20]. Several screening tools have been developed and
validated to identify people at risk for poor health literacy and to
evaluate its association with medication knowledge [21–25].
However, these tools do not seem to be applicable to large-scale
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A. Calamusa et al. / Patient Education and Counseling 87 (2012) 395–401
questionnaire surveys, as they cannot be completed easily without
help, especially by people with low literacy, defined as scored at level
1 of 5 in prose and document competencies [26].
In the wider concept of health literacy Nutbeam (2000) defined
three different levels (functional, communicative and critical): the
‘‘functional health literacy’’ (FHL) represent the baseline literacy
individual skills (reading, writing and making simple calculations)
that enable people to read and understand health information. The
majority of research in clinical settings has focused on FHL,
considered as mediating factor in health and clinical decisionmaking [Nutbeam, 2008]. ‘‘To this aim several screening tools
(REALM [21,22] TOFHLA [23,24]) have been developed and validated
to identify people at risk for poor functional health literacy and to
evaluate its association with medication knowledge [25]. In some
research studies about clinical conditions such as asthma, hypertension, diabetes, and heart failure, specific aspects of baseline
conceptual knowledge have been measured to understand a
patient’s learning needs before an educational program. These
measures of disease-specific knowledge generally show a direct,
linear correlation with measures of reading fluency [19].
As a consequence of the ongoing evolution of OTC distribution
across Europe, in Italy since August 2006 all non-prescription
medicines, can be sold in channels other than traditional pharmacies,
such as supermarket corners, selling also products like herbal
remedies, cosmetics etc. In these areas customers can chose
medicine by themselves, although the presence of a pharmacist is
compulsory at the cash desk to give information and advices. Such a
big change in the OTC medicines distribution could lead to an
increase of unsafe behaviors if customers are unaware of risks related
to self-medication and unable of understanding the information
provided by the Package Information Leaflet, that is a leaflet inserted
within the outer packaging of the medicinal product containing
information about its use and risks (EU Directive 2001/83/EC).
In Italy no systematic research has been conducted on health
literacy and its association with medication knowledge. The
functional literacy of the general adult population as reported by
an international study [26,27] is a matter of concern because more
than 45% of people aged 16–65 years were scored at the lowest
level of prose and document literacy.
The aim of this study was to survey Italian consumers’
functional health literacy, specific knowledge and risk awareness
about over-the-counter (OTC) medicines, and associated factors.
The questionnaire survey was performed at select health sections
of Coop, Italian leading company in modern retail, where OTC and
health products are sold under the professional supervision of
pharmacists. The results of this survey were the first step in
designing an information and communication programme focusing
on consumer needs.
2. Methods
2.1. Survey design and questionnaire development
In a preliminary phase a literature review was carried on PubMed
database using the keyword ‘‘self-medication’’. Among the 3880
found references; a further selection was made considering studies
about readability and understandability of package leaflets;
knowledge; attitudes; perceptios; behaviors and pharmacist
counseling. Objectives and methods of these surveys were compared
to choose the study design and questions most appropriate for our
purpose. A first set of questions exploring the areas of interest for our
survey were then asked to a sample of 64 customer attending 8
shopping centres in different cities; using two different methods:
semi structured interview (35 people) or self-administered questionnaire (29). The overall response rate was 43% and the most
frequent motivation of refusing was the hurry. This preliminary
study showed that interviews were time consuming (25 min each)
and very difficult; owing to the large turnout of customers: then a
self-administered questionnaire (15 min for compilation) was
chosen for the survey; although this method could cause a possible
selection bias; requiring at least basic reading and writing skills.
The first draft of the questionnaire was then tested in 4 focus
groups (36 people) and on a convenience sample of 78 university
students, in order to fine tune its completeness, readability,
comprehensibility and acceptability.
A second pilot study, aimed to test the final version of the
questionnaire and its distribution method in the real setting, was
then carried out on a sample of customers (210) at the health
section of the Livorno Coop supermarket [28], a real setting before
conducting the large-scale survey.
The final questionnaire (available from the authors upon
request) consisted of 18 close-ended questions and was divided
in 4 sections:
(1) Demographic data (age, gender, education), current use of
prescription drugs and information sources about minor ailments;
(2) Functional health literacy/knowledge section: to measure the
ability of reading and understanding information (FHL) related
OTC use, a specific new tool was designed, divided in three subsection. The first (vocabulary) investigated the interpretation
of most frequent technical words in information leaflet, the
second (numeracy) the solution of a simple dosage calculation,
the third (knowledge) the awareness about OTC meaning,
distribution and identification.
(2.1) Vocabulary: 17 high frequency terms were chosen from a
list of the most common words obtained through a
computational linguistic analysis [29] on a sample of 38
OTC PILs. The understanding of 12 of these terms was
tested by asking participants to place them in the correct
section of a stylized body divided into four sections
(Fig. 1). The meanings of five further terms (‘‘analgesic’’,
‘‘active principle’’, ‘‘dosage’’, ‘‘contraindications’’, ‘‘interactions’’) were asked in multiple-choice questions.
(2.2) Numeracy: it was evaluated by asking subjects to
calculate the maximum number of pills not to be
exceeded per day according to the PILs instructions:
‘‘Take 1 or 2 tablets once or twice a day’’.
(2.3) Knowledge of OTC: the synonyms of ‘‘non-prescription
medicines’’ were asked, focusing on the possible confusion
between OTC and ‘‘generic’’ medicine (i.e. a drug marketed
without brand name which is equivalent to a brand
reference medicine); moreover the knowledge of OTC
distribution channel and identification symbol, which is
printed on the outer package of all non-prescription
medicines, by national regulations, was tested.
(3) Risk awareness: a list of twelve statements representative of
three risk categories (‘‘drug interactions’’, ‘‘side effects’’ and
‘‘abuse/misuse’’) was presented for true/false/do not know
responses.
(4) General attitudes and practices regarding the purchase/use of
OTC drugs and PILs: personal motivation for buying OTC drugs,
tendency to tell the pharmacist about the concomitant use of
other drugs and to read the PIL, PILs understanding and
psychological impact were investigated (was the PIL helpful,
alarming or confusing?).
2.2. Questionnaire distribution
Data were collected from a convenience sample of 1.206 adults
aged 18 years and older through a self-administered questionnaire.
All questionnaires were collected in the health sections of six Coop
large super stores (that include multiple stores, such as a
A. Calamusa et al. / Patient Education and Counseling 87 (2012) 395–401
397
Fig. 1. Functional health literacy skills: Knowledge of body location of 12 select terms, definition of 5 select terms and numeracy skill. Participants were asked to place the first
12 terms in the right section of a stylized body divided into four sections. Multiple-choice questions were used to test knowledge of the definition of the other 5 words. The
English translations of some of these Italian terms may not adequately reflect their frequency of use in the general population of native English speakers. The plain language
translation of technical words is reported following: Cephalea: headache; Gastritis: inflammation of the lining of the stomach; Meniscus: a wedge of cartilage in the knee
joint; Oral: to be taken by mouth; Antacid: a substance used to treat acidity in the stomach; Laxative: a medicine that induces the emptying of the bowels; Peptic ulcer: an
ulcer in the stomach or duodenum; Mucolytic: an agent that reduces the viscosity of mucus; Hepatic: of the liver; Constipation: a condition in which emptying one’s bowels is
difficult; Nephritis: inflammation of the kidney; Hematouria: blood in urine; Analgesic: a drug that relieves pain; Active principle: a constituent of a substance that
determines its characteristics; Posology: dosage. The ability to perform simple dosage calculations was assessed by asking participants to calculate the maximum number of
pills not to be exceeded per day based on the instructions ‘‘Take 1 or 2 tablets once or twice a day’’.
supermarket, a pharmacy, a department store) located in northern
(Milan, Turin, Bologna), central (Sarzana, Rome) and southern Italy
(Bari). The study was conducted over a five-week period between
November and December 2008. The questionnaire was distributed
three days a week in each shopping centre, from 10:00 A.M. to 6:00
P.M., on different days of the week (from Monday to Saturday) in
order to cover as many customer shopping patterns as possible. A
desk, clearly evidenced by posters with the study purpose, was
placed at the entrance of each ‘‘health corner’’ (that is the space were
OTC are sold in supermarkets). Two trained members of the research
team invited to participate every adult customer who entered this
area, excluding people evidently vision and cognitively impaired;
the purpose of the research was explained and instructions given on
how to complete the anonymous questionnaire. The questionnaires
were filled out on site and immediately collected in a closed box to
guarantee the anonymity. The questionnaire took respondents
15 min on average to complete. No incentive (e.g. discount on
purchases) was offered; those who completed the questionnaire
received the correct answers as educational feedback.
Due to the large turnout of customers in the natural setting of the
study, a precise calculation of the response rate was not feasible
during the large survey, Then, to estimate the response rate we
considered data from pilot tests, when people who refused were
asked reason for not participating: as previously reported the overall
response rate was 43% and the most frequent motivation of refusing
was the hurry.
2.3. Data analysis
Except for the age and the number of pills calculation, all
answers were coded as qualitative data and entered into Excel for
WindowsTM. The spreadsheet was then converted and analysed
using the SAS System software (Version 8.2). The relative
frequencies of the different answers to each question were
calculated, also taking into account missing responses. Participants
level of knowledge and risk awareness were evaluated as scores by
awarding 1 point for each correct answer, 0.8 for each partially
correct answer, 0 for each incorrect, ‘‘do not know’’ or no response.
For the vocabulary skills related to the stylized body, a weighted
score was attributed to each correct answer depending on the
difficulty level of each term as assessed in the pilot studies. The
mean total score of the study population and its variability were
then calculated, together with the mean knowledge and risk
awareness sub-scores. The maximum total score achievable was
27 (15 for the knowledge sub-score and 12 for the risk awareness
sub-score).
In order to evaluate the influence of information sources we
divided the respondents into four sub-groups depending on the
sources cited: (1) personal professional sources (doctor and/or
pharmacist), alone or associated with other sources, excluding
PILs; (2) personal professional sources, alone or associated with
other sources, including PILs; (3) non-professional sources,
excluding PILs; and (4) non-professional sources, including PILs.
Continuous variables were summarized by mean values and
standard deviations, the categorical ones by proportions. Pearson’s
chi-square test was used to compare categorical variables and the
Cochran–Armitage test to evaluate the trend in age or educational
in binomial tables. The Student’s t-test was used to compare twosample means and the General Linear Model (GLM) approach to
the analysis of variance to simultaneously compare means among
levels defined by categorical characteristics of participants. Once a
significant difference was found in the analysis of variance, the
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A. Calamusa et al. / Patient Education and Counseling 87 (2012) 395–401
Bonferroni t test, alfa level = 0.05, was used in multiple comparisons.
Spearman correlation coefficient was used to estimate the association among ordinal variables. Lastly, in order to identify the variables
most closely associated with correct knowledge and risk awareness,
a multiple logistic regression was performed. We decided to use the
multiple logistic regression model due to the lack of normality of
total score distribution (Shapiro–Wilk W = 0.95, p < 0.0001; Kolmgorov–Smirnov D = 0.085, p < 0.01). To this aim, the total score was
divided into two levels (<21 and = or > 21 based on its median
value), the education into two categories (primary/middle and
secondary/degree) and the age into four classes: 18–29, 30–44, 45–
59 and the last 60 years which was taken as reference in the logistic
analysis. Probability of alpha levels less than 0.05 were considered
statistically significant. Sas software, version 8.2, has been used for
all statistical computations.
3. Results
3.1. Sample characteristics
On the whole, 1.206 questionnaires were collected. The
participants’ characteristics are shown in Table 1. About 44%
professed to take prescription medicines regularly, without gender
difference, but with a positive age related trend (Cochran–
Armitage trend test: z = 12.95, p < 0.0001), and a significant
association with the education level (Cochran–Armitage trend
test: z = 7.0, p < 0.0001), indicating an higher use of prescriptions
in people with lower education levels.
3.2. Information sources about minor ailment remedies
The most frequently cited information sources were personal
ones (61.5% doctor, 40.4% pharmacist, 26.5% friends/relatives);
4.5% declared that they did not use any source of information, but
decided on their own. Written and mass-media sources were less
commonly mentioned (16.5% PIL, 8.6% journals/magazines, 8.5%
internet, 7.5% television, 4.5% advertising). Regarding the professional sources (doctor and/or pharmacist), females were more
likely to cite them than males (81.6% vs 74.3%, p < 0.005), while
there was no difference in terms of age or education or prescription
drug use. PIL was less frequently cited by males than females
(12.5% vs 19.6%, p < 0.01), by those aged 60 than other age groups
(9.8% vs 19.3%, p < 0.001), by those with lower education (primary/
middle) than those with higher education (secondary/degree;
11.1% vs 18.3%, p < 0.01) and by prescription drug users than nonusers (13.0% vs 18.8%, p < 0.01).
3.3. Health literacy, knowledge and risk awareness
The knowledge and risk awareness sections were filled out to at
least 80% by 1.061 respondents (88% of the study sample): for the
analysis regarding these aspects we used data from the respondents who completed all sections of the questionnaire.
The literacy skills results are shown in Fig. 1: correct body
placement varied from 90.0% for ‘‘cephalea’’ to 28.3% for ‘‘haematuria’’. A lexical confusion between the concepts of drug contraindications and side effects was found in 30% of respondents. More
than half of participants gave the correct answer to the numeracy test,
with a significant association with education level (82% secondary/
degree vs 18% primary/middle, p < .0001). Among the wrong
answers, the lower dosage predominated (34.2% against 4.4%).
Almost half of respondents gave the correct answer about the
meaning of ‘‘non-prescription’’ medicines, but 41.7% confused
them with ‘‘generic’’ drugs. Only 61.4% of the respondents
recognized the OTC identification symbol. Most respondents knew
that only non-prescription drugs can be sold in supermarkets.
Table 1
Background characteristics of Italian health section clients of a retail chain
participating in the study (total = 1.206).
Gender (n = 1.145)
Female
Male
Age (n = 1.145)
18–29 years
30–44 years
45–59 years
60
Education (n = 1.145)
Primary (grades 1–5)
Middle (grades 6–8)
Secondary (grades 9–13)
University degree
Use of prescription drugs (n = 1.146)
Yes
No
Information sources (n = 1.198)*
Group 1a
Group 2b
Group 3c
Group 4d
*
a
N
(%)
637
508
(55.6)
(44.4)
109
347
337
352
(9.5)
(30.3)
(29.4)
(30.7)
80
238
590
237
(7.0)
(20.8)
(51.5)
(20.7)
510
636
(44.5)
(55.5)
794
148
205
51
(66.3)
(12.3)
(17.1)
(4.3)
Participants were divided into four groups depending on stated sources.
Group 1: professional sources, alone or associated with other sources, excluding
PIL.
b
Group 2: professional sources, alone or associated with other sources, including
PIL.
c
d
Group 3: non-professional sources, excluding PIL.
Group 4: non-professional sources, including PIL.
The results of the risk awareness section are shown in Fig. 2. Most
respondents were aware of the risks related to OTC drugs’ potential
for side effects. On the other hand, the drug interaction risk category
revealed the highest percentage of incorrect and ‘‘do not know’’
responses, in particular about the risk of using painkillers for people
suffering from high blood pressure. With regard to the misuse/abuse
risk category, 14 and 20% of respondents showed inadequate
awareness of the risks related to the long-term use of laxatives and
nasal decongestants, respectively.
The scores for knowledge and risk awareness are presented in
Table 2. The mean total score was 20.12 (SD 4.15, range 2.00–
27.00). Scores were directly associated with female gender and
education level. Moreover, the middle age groups between 30 and
59 years achieved higher mean totals than younger and older
groups. Similar associations were found for the mean knowledge
and risk awareness sub-scores.
No significant differences were found between prescription drug
users and non-users for mean total score or the two mean subscores.
The subgroups citing PILs as information source had significantly
higher mean knowledge and total scores. Those who cited nonprofessional sources without doctor or pharmacist, but included PILs
among their sources had significantly higher knowledge and total
scores, while there was no significant difference between the
subgroups for the risk awareness sub-score.
These results were confirmed by multiple logistic regression.
Higher total scores were directly associated with higher
education level (OR 2.9; 95% CI 2.1–4.1), female gender (OR
1.8; 95% CI 1.4–2.4) and the citation of PILs among the
information sources (OR 1.7; 95% CI 1.2–2.5). Regarding age,
the oldest one taken as reference, adults aged between 45 and 60
years had significantly higher total scores (OR 1.7; 95% CI 1.2–
2.4) and young aged between 18 and 25 years significantly lower
(OR 0.3; 95% CI 0.2–0.5).
The correlation between functional health literacy and risk
awareness sub-scores was slightly positive (Spearman correlation
coefficient 0.38).
A. Calamusa et al. / Patient Education and Counseling 87 (2012) 395–401
Correct
Incorrect
"I don't know"
399
Missing
DRUG INTERACTIONS
It's better to tell the pharmacist if you are taking
other medication
If taken together, two painkillers work better
Non-prescription drugs may not "agree with"
with other drugs
Those who suffer from high blood pressure
should use painkillers with caution
MISUSE/ABUSE
It's important to consider children's weight
before giving them drugs
Laxative drugs, if used regularly to lose weight,
are potentially harmful
Long-term use of nasal decongestants is
potentially harmful
Those who suffer from constipation must take
laxative drugs regularly
SIDE EFFECTS
Even non-prescription drugs may cause side
effects
Painkillers may damage the stomach
A drug promoted through advertising is safer
Some drugs against allergies may cause
sleepiness
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Fig. 2. Perception of risks associated with OTC drug use, according to three risk categories: drug interactions, misuse/abuse, side effects. Participants were asked to indicate
whether each statement was true or false; the option ‘‘do not know’’ was also included. The results are presented as correct answers regardless of whether true or false.
3.4. Attitudes and practices regarding the purchase and use of OTC
drugs and package leaflets
Only 39.8% of the sample declared telling their pharmacist that
they take other drugs at the time of purchase, with no difference
between prescription drug users and non-users. Most respondents
reported that they read PIL every time they buy an OTC medication,
mainly regarding the dosage instructions and side effects, but only
38.1% professed to completely understand their contents, with
significant differences between education levels (46.1% for
secondary/degree versus 26.0% for primary/middle p < .0001).
The impact of reading the package leaflets was reportedly
Table 2
Participant characteristics associated with knowledge (the maximum score was 15), risk awareness (the maximum score was 12) and total mean scores (the maximum
achievable total score was 27).
Knowledge sub-score
Risk awareness sub-score
Mean
Total score
Characteristic
Mean
SD
p value
SD
p value
Mean
SD
p value
Total sample
Gender
Male
Female
Age
18–29 years
30–44 years
45–59 years
60 years
Education
Primary (grades 1–5)
Middle (grades 6–8)
Secondary (grades 9–13)
University degree
Use of prescription drugs
Yes
No
Information sources*
Group 1a
Group 2b
Group 3c
Group 4d
10.38
3.02
–
9.60
2.06
–
20.12
4.15
–
9.99
10.79
2.96
2.98
<.0001
9.34
9.85
2.15
1.87
<.0001
19.40
20.82
4.10
3.96
<.0001
9.33
10.93
10.99
9.62
2.77
2.74
2.91
3.23
<.0001
8.96
9.71
9.93
9.48
1.96
1.82
1.88
2.24
<.0001
18.38
20.67
21.01
19.35
3.97
3.90
3.91
4.23
<.0001
7.63
9.09
10.53
12.01
3.25
2.99
2.86
2.22
<.0001
9.01
9.45
9.62
10.05
2.37
2.20
1.97
1.72
0.0002
17.09
18.70
20.22
22.09
4.22
4.23
3.98
3.23
<.0001
10.27
10.51
3.15
2.93
0.22
9.52
9.71
2.15
1.89
0.10
19.94
20.31
4.27
4.01
0.16
10.27
11.28
10.09
10.65
3.08
2.68
2.94
2.98
0.002
9.59
9.80
9.49
9.82
2.04
1.95
2.15
2.00
0.43
19.96
21.27
19.77
20.74
4.17
3.97
4.11
3.98
0.003
Note: Total score, knowledge and risk awareness sub-scores were calculated for each respondent by awarding assigning 1 point for each correct answer, 0.8 for each partially
correct answer, 0 for each incorrect, ‘‘do not know’’ or no answer. The mean scores are associated to gender, age groups, education levels, use of prescription drugs and
information sources on minor ailment remedies The mean total score of the study population and its variability was then calculated, together with the mean knowledge and
risk awareness sub-scores. p values are the probabilities of an alfa error as defined by Anova analysis.
*
Participants were divided into four groups depending on stated sources.
a
Group 1: professional sources, alone or associated with other sources, excluding PIL.
b
Group 2: professional sources, alone or associated with other sources, including PIL.
c
Group 3: non-professional sources, excluding PIL.
d
Group 4: non-professional sources, including PIL.
400
A. Calamusa et al. / Patient Education and Counseling 87 (2012) 395–401
perceived as helpful by 67.3% of respondents, but as alarming by
22.6% and as confusing by 9.2%.
4. Discussion and conclusion
4.1. Discussion
This study was intended to explore the consumers’ functional
health literacy, specific knowledge and risk awareness about overthe-counter (OTC) medicines in order to develop an educational
program tailored to the real information needs.
The results of this study are in line with other surveys which
point to the doctor and the pharmacist as the public’s main sources
of information on general health matters and on drug usage,
women being more likely to choose personal professional sources
than men [2–5,32,33].
Regarding information needs, the mean score resulting from
the study revealed that the majority of respondents have a good
knowledge and risk awareness related to OTC drugs. As reported
in previous studies [25,30], functional health literacy, including
vocabulary, reading and numeracy skill, is directly associated
with education level, age and female gender. However, a better
understanding of the information could be obtained by using
plain language, glossaries and clear explanations. Although
European Directive [31] dictates that PILs must be written and
designed to be clear and understandable, and Italian national
regulations [32] require that terms such as ‘‘contraindications’’,
‘‘active principle’’ and ‘‘dosage’’ are to be substituted by
standard explanatory wordings, a difficult language is still
present in several national OTC PILs (as revealed by the analysis
of 38 PILs). Also the results about the numeracy skills showed
that quantitative dosage instructions can be misinterpreted and,
as other studies suggest [33], it is essential to optimize dosage
instructions in PILs and to specify the maximum number of pills
not to be exceeded per day.
Although the level of risk awareness is generally high, between
10 and 65% of respondents are not fully aware of several risk areas,
particularly regarding drug interactions and misuse/abuse. These
results show that OTC risk awareness should be increased in the
general public, as indicated in previous studies [4,14,17]. Our study
reveals that prescription drug users do not show a higher drug
interaction risk awareness in comparison to non-users, neither a
more positive attitude in informing a pharmacist of the concomitant use of other drugs. Although in our study most people showed
to be aware of the potential gastric damage of OTC NSAIDs, another
fairly common risk condition, such as the concomitant use of these
drugs and antihypertensive prescription medicines, is scarcely
known. Furthermore up to 22% of respondents are unaware of OTC
misuse risks, e.g. long-term use of laxatives and nasal decongestants. Even the rising trend in OTC abuse, such as the long-term
use of laxatives to lose weight, should be deepened in future
studies, as also suggested in other studies [4,11]. Higher education,
female gender, adult age (44–60 years) and the citation of PIL and
non-professional information sources are independent variables
predictive of higher total scores. As well as the oldest age 60
years, the youngest age class (18–29 years) is associated to the
probability to have lower scores.
The results on information sources are in line with other
surveys which point to doctors and pharmacists as the public’s
main sources on general health matters and on drug usage, women
being more likely to choose personal professional sources than
men [2–5,34,35].
Regarding the package leaflet, although there is a general
positive attitude towards its consultation, this study shows that,
while the vast majority declared they could read it, less than half
said they understood it in accordance with a research published in
2000 [36]. Nevertheless this study suggests that the PIL may be an
important factor affecting knowledge and risk awareness as
respondents who cited PIL among information sources had
significantly higher knowledge scores.
Some limitations in the present study must be considered
when interpreting the data. Potential selection bias can be due to
questionnaire distribution: the self-compilation probably excluded people unable to read or vision impaired. For this reason
the sample had an education level higher than expected on the
basis of national data. Besides, excluding Sunday from the
questionnaire distribution could have also excluded people who
work weekdays.
In fact probably the study has overestimated the general
public’s knowledge and risk awareness. Besides not all critical
issues related to OTC medicines could be covered in the
questionnaire. We tried to focus on a mix of knowledge, skills
and awareness that can foster consumer wisdom and responsibility in choosing and using OTC drugs.
4.2. Conclusion
The present study is the first to explore functional health
literacy regarding OTC medicines in a sample of Italian
consumers. The results show gaps in understanding the
vocabulary of package leaflets and in the ability to calculate
maximum daily dosages, as well as a low awareness of risk,
mostly related to drug interactions and misuse/abuse. The OTC
marketplace is still evolving, and with it, the knowledge and risk
awareness of the general public. Further studies will therefore
be essential in order to monitor the public’s growing need for
information on self-medication.
An all-out effort is moreover required to increase public’s
knowledge and risk awareness of potential side effects, drug
interactions and misuse/abuse. Our results indicated that all
consumers, regardless of their literacy skills, need to be educated
about OTC medicines and their risks. Educational programmes
should address both a pharmacist-assisted self-care model and
written information materials, which must contain scientifically
reliable information presented in a form that is easily understandable, acceptable and useful to consumers.
4.3. Practice implications
The results of this study have implications for both health
professional-patient communication regarding the risks of OTC
medications and the development of educational programmes
tailored to consumer information needs. Following the data
analysis, we developed an intervention plan, including information
tools for customers, available at supermarket health sections and
on the retailer’s Website [37]. The intervention plan also included
meetings with the retailer’s pharmacists in order to sensitise them
to the results of the study and their key role in meeting OTC
consumers’ information needs.
From a methodological perspective the next step is to test the
questionnaire further in comparison to standardised health
literacy screening tools, such as REALM, and transfer the method
to other functional health literacy areas to guide the development
of educational programmes.
Acknowledgements
The study was co-funded by Coop and the University of Pisa. No
ethical approval was required. The authors would like to thank the
management, pharmacists, members and clients of Coop sites for
their co-operation during the study.
A. Calamusa et al. / Patient Education and Counseling 87 (2012) 395–401
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