Author Title Subject Argument Country Evaluation

An AD-HOC MINIMUM INFORMATION FOR A guide was designed Leaflets produced by professional organisations An independent 2/3. Clinical Pharmacologists/physcians ideas
working group, SENSIBLE USE to specify what information is required to meet are generally unsuitable for these purposes of a group, mainly clinical regarding the minimum information that is required
1977 OF SELF-PRESCRIBED the needs of patients, with regards to their medications. patient, information sets should be put together pharmacologists and by patients (with regards to their medication).
MEDICINES by small independent groups consisting of physicians from 16
An International Consensus clinical pharmacologists, clinicians, pharmacists, countries
and consumers.

Hermann, 1978 Package inserts for prescribed
medicines: what minimum
information do patients need?
When the medicine has been dispensed the patient needs
to know how to take the drug; how to store the drug; how it
is expected to help; and how to recognise problems and
what to do about them. A guide was designed to specify
what information is required to meet these needs. Using
this guide, a set of minimum information on tetracycline
was prepared that aimed at being brief, specific, and
readable. The best format for the information remains to be
determined.
Since leaflets produced by professional United States, United
organisations are generally unsuitable for these Kingdom, Sri Lanka
purposes, information sets should be put
together by small independent groups consisting
of clinical pharmacologists, clinicians,
pharmacists, and consumers. Each country
should produce its own sets, adapting model
sets to the circumstances of local practice.
1/2. Fidnings suggest that information sets should be
put together by small independent groups consisting
of clinical pharmacologists, clinicians, pharmacists,
and consumers. Each country should produce its own
sets, adapting model sets to the circumstances of
local practice.

Morris, 1980 Consumer Reactions to Differing Four prototype patient package inserts (PPIs) for There was no difference in the total amount of United States 3. Produces findings to differing amounts of written
Amounts of Written Drug erythromycin were tested in an analog study using 325 knowledge communicated by the different PPIs, drug information on patient package inserts.
Information individuals drawn from a college community. but results for individual test items suggest more
explicit information may be better recalled, and
longer PPIs may aid in information integration,
whereas shorter PPIs may aid in pure recall of
facts. PPIs containing elaboration on why drug
effects occur were rated by the subjects as more
accurate. Subjects tended to rate PPIs that
provided behavioural instructions on what to do
if certain drug effects occurred as designed to
promote better care.

Ridout, 1986 What information do patients Respondents (62%) felt that not enough was explained Most patients need to have more information United Kingdom 3. Findings suggest that patients would like
need? about medicines by doctors or pharmacists. Eighty-three about prescribed medicines and they would medicines information leaflets when given a
per cent of respondents thought an information leaflet welcome written leaflets. However, further work prescription for medication.
would be helpful. is necessary to determine the best format for
such leaflets.
Gibbs, 1989 The benefits of prescription Patients knowledge regarding their medication was Significantly more patients United Kingdom 3. Statistically significant findings were produced
information leaflets assessed, with two towns being compared. One towns who received leaflets knew the potential side- suggesting patients who receive patient information
patients received patient information leaflets, while another effects of their treatment and, were more leaflets, know more about their medications, and are
town did not. satisfied with the information they received. more satisfied with the information they receive.

Harvey, 1991 Comparative attitudes to verbal Study was undertaken to assess the comparative preference Patient preference for a leaflet or verbal Australia 2/3. Produces findings on what sort of information
and written medication of pharmacy outpatients for verbal and written medication counseling with a leaflet provides further patients value in medicines information
information among hospital information and to identify factors that might influence evidence that leaflets should be widely used.
outpatients. these preferences

Researched Consumer Product Information: Comprehensive explanations of the ideas and arguments for New Zealand. 2/3. Gives a 1994 New Zealand perspective.
Medicines What you should know about and against consumer product infomration in the year 1994,
Industry your medicines. for New Zealand.
Association

Berry, 1995 What Do Patients Want to
Know: An Empirical Approach to
Explnation Generation and
Validation
Reports three studies that investigate what patients want to
know when they have been prescribed
medication. The question is asked in the context of the
development of a drug prescription system
called OPADE. The system is aimed primarily at improving
the prescribing behaviour of physicians,
but will also produce written explanations for indirect users
such as patients.
For an explanation to be considered useful it had United Kingdom
to include information about side effects, what
the medication does, and any lifestyle changes
involved.
2. Details finsings of three studies lo9oking into what
patients want/require with regards to medicines
information, in the context of OPADE, a computer
based prescription software, that is able to produce
indivualised medicines infomration for patients.

Laires, 1995 Health in the New One chaptor: OPADE: Optimisation of drug prescription European Union 3. Talks about testing/implemetation of a
Communications Age: Health using advanced informatics. (Belgium) computerised drug prescription system that is able to
Care Telematics for the 21st talour medicines information to individual platiients
Century to aid in compliance.

Wise, 1996 Development and evaluation of

a novel patient information
system
Berry, 1997 What do patients want to know,
An empirical approach to
explanation generation and
validation
Mottram, 1997 Comparative evaluation of
patient information leaflets by
pharmacists, doctors and the
general public
Raynor, 1998 The Influence of Written
Information on Patient
Knowledge and adherence to
Treatment
Amery, 1999 Coming Full Circle in
Pharmacovigilance:
Communicating Safety
Infomratio to Patients Through
Patient Package Inserts
da Silvia, 2000 Drug package inserts and the
adequacy of patients drug
information
Comparison to how doctors rate a list of information Patients have different ideas regarding what they United Kingdom 2/3. Produces findings on what information patients
categories (regarding medicines information (identified by want to know about their medications value in medicines information in comparison to
Berry, Gillie and Banbury 1995)) compared to patients, with incompaison to what doctors thought patients what doctors think patients should value, as well as
regards to importance. should know. findings reporting that the inclusion of negative
information relating to the medication in medicine
infomration, has a negative effect on compliance.
This study was undertaken to compare and contrast the United Kingdom
views of pharmacists, general practitioners (GPs) and the
general public on the value or otherwise of pharmacy-
generated patient information leaflets.
(Book chapter). How can information influence adhearnce? United Kingdom 2/3. Comprehensive book chapter on medicines
What are the main catagories of written information? What information and its affect on patient
is the effect of patient information leaflets on knowledge compliance/adhearnce.
and adhearnce (USA and UK studies), Written or verbal
information? Patient information leaflet initiatives in the
USA and UK, Idividualised written information, the link
between written information, transfer of knowledge and
adhearnce, preparing effective written information, method
of delievery, design and layout, content, piloting of written
information who does written information exclude,
adhearnce and written informaton the way forward.
(Summary). Belgium
To investigate the adequacy of the content and format of Important information for the drug user was not Brazil 3. Findings produced suggest that in Brazil, medcines
the patient information section in package inserts of presented in package inserts analysed, limiting infomration leaflets do not contain important
commonly prescribed drugs at the internal medicine service the purpose of inserts as an instrument for information, thus limit the purpose of inserts as an
of a school hospital. patient education. instrument for patient education.
Robson, 2001 Pharmaceutical and Medicines (Book). A number of possibly useful chapters: Medical United Kingdom 4/3. Possible useful chapters.
Information Management: information in the pharmaceutical industry. Research
Principles and Practice information in the pharmaceutical industry. Legal and
ethical requirements for drug information pharmacists.

Patient information leaflets for
medicines: using consumer
testing to determine the most
effective design.
This exploratory study compared consumers ability to use a
leaflet based on the EC model leaflet and an alternative
leaflet based on best practice in information design (Mark
II).
Open questioning confirmed the problems with United Kingdom
the European Commission leaflet, including a
failure to understand key concepts about
medicine interactions and contraindications. This
research demonstrates the benefits of consumer
testing, ensuring that leaflets are patient-
orientated.
1/2. Idetified problems with the European
Commission leaflet, including a failure to understand
key concepts about medicine interactions and
contraindications. This research demonstrates the
benefits of consumer testing, ensuring that leaflets
are patient-orientated.

Dixon-Woods, Writing wrongs? An analysis of
2001 published discourses about the
use of patient information
leaflets
Much has been written about how to communicate with
patients, but there has been little critical scrutiny of this
literature. This paper presents an analysis of publications
about the use of patient information leaflets.
It suggests that two discourses can be United Kingdom 3. Scrutinises literature on patient information
distinguished in this literature. It reflects leaflets.
traditional biomedical concerns and it invokes a
mechanistic model of communication in which
patients are characterised as passive and open
to manipulation in the interests of a biomedical
agenda. This second discourse draws on a
political agenda of patient empowerment, and
reflects this in its choice of outcomes of interest,
its concern with the use of leaflets as a means of
democratisation, and its orientation towards
patients.

Krass, 2001 Using alternative methodologies A variety of direct and indirect methods have been used to
for evaluating patient
medication leaflets
In conclusion, we confirmed the importance of United States 3/4. Assessed alternative methodologies for
evaluate written medication information; however, no design characteristics in the production of evaluating patient medication leaflets.
published research has validated assessment tools or written medication information and have also
presented direct consumer assessment of patient developed and validated two easy-to-use tools
information leaflets (PILs) provided in US community for the assessment of written medication
pharmacy (CP). We report on two new instruments: the information
medication information design assessment scale (MIDAS),
an indirect measure of design quality administered by the
investigators, and the consumer information rating form
(CIRF), a direct measure of comprehensibility, utility, and
overall design quality applied by a consumer panel.
Nair, 2002 What patients want to know
about their medications:
Dickinson, 2003 Ask the patientsthey may
want to know more than you
think
Gustafsson, A Method to Evaluate Patient
2003 Information Leaflets
Mansoor, 2003 Effect of Pictograms on
Readability of Patient
Information Materials
Schaafsma, Accessing medication
2003 information by ethnic
minorities: barriers and possible
solutions
Focus group study of patient and clinicain persepctives, on Patients want information about the Canada 2. Discusses patients wants regarding medicine
what is required in medicines information. medications they are prescribed. Patients want information with specific findings relating to patients
to know that proposed medications are right for wanting treatment information, explidely
them personally. personalised for their own unique health situations
[Opinion piece] In interviewing people about drug
treatments,5 6 we
have consistently noticed that people respond to four
essential aspects of a drug:
x Side effects
x What it does and what its for
x Dos and donts
x How to take it.
The aim of this study was to develop a useful method for We conclude that patient information leaflets Sweden 3. A method for evaluation medicines information.
evaluating patient information leaflets by comparing the that score above average on the expert
result of expert and patient evaluations. The hypothesis was examination of con tent (ie, adherence to the
that if there was a correlation between the results of these directive) will also score above the average on
evaluations it would be acceptable to only do expert review the patient examination.
for patient information leaflets currently in use.
To design, develop, and evaluate a simple, understandable The presence of pictograms had a positive effect South Africa 3/4. Effect of Pictograms on Readability of Patient
medicine label and patient information leaflet (PIL) for in the acquisition and comprehension of drug Information Materials
nystatin suspension, and to assess the effect of information.
incorporating pictograms on understanding in low-literate
participants.
This review discusses two main questions: how suitable is Barriers to the access of medication information Neatherlands 2. Discusses the situation of ethnic minoritoes
current consumer medication information for minority by ethnic minorities include second language accesssing medicines information.
ethnic groups, and what are effective strategies to overcome issues and cultural differences due to different
existing barriers. The focus is on minority groups whose first health beliefs, together with the low socio-
language is not the language of the healthcare system. economic status often seen among ethnic
minorities.
Hameen-Antilla, Do pictograms improve
2004 childrens understanding of
medicine leaflet information?.
Shaw, 2005 Information for patients on
medicines
Hamrosi, 2006 Pharmacist and general A qualitative study was conducted to explore the opinions
practitioner ambivalence about and attitudes of healthcare professionals toward the use of
providing written medicine written medicine information in practice.
information to patients - A
qualitative study
Grime, 2007 The role and value of written
information for patients about
individual medicines: a
systematic review
The aim of this study was to test whether children
understand pictograms developed by the United States
Pharmacopeia (USP), and especially, if the pictograms
improve childrens understanding of medicine leaflet
information.
The Medicines Information Project has shown that
the pharmaceutical industry can develop information
for patients and the general public about medicines,
under the direction of a multisector board that
includes patients organisations, health professionals,
and the medicines regulator.
To review research on the role and value of written
medicines information for patients from the perspective of professionals, and the diverse and changing
patients and health professionals.
Most of the children understood the meanings Finland 3/4. The understanding of pictorgrams by children
of the selected 15 pictograms correctly. Even when used in medicines infomration leaflets.
well-understood pictograms did not help the
children understand the leaflet information,
although they reduced the need for probing.
This study shows that the context in which
pictograms are tested makes a difference in the
results. Testing plain pictograms without
incorporating them in their real context, e.g., in
the patient information leaflet may exaggerate
their usefulness in leaflet information.
These guides have advantages over mandatory United Kingdom 3. Shows evidence of where a project has produced
patient information leaflets. They can be guides that can be indivulised to a specific
customised to provide only the information patient/indication.
relevant to a specific indication; they discuss
medicines in the context of all available
alternatives, including non-drug options; and
they link to relevant clinical information about
conditions.
Participants were ambivalent about supplying Australia, United 2/3. Produced findings surrounding the opionons of
written medicine information to their patients Kingdom halth professionals in regards to medicine
and concerned about its impact on the patient- infomration, as well as made the conclusion that
provider relationship. A tailored approach to there is a possible requirement for patient taloured
meet individual patient information preferences, medicines information.
together with efforts to support professionals as
facilitators of information may increase written
medicine information utilization as an
information-sharing tool to improve health
literacy and patient engagement.
The different perspectives of patients and health United Kingdom 2/3. A systematic review on the role and value of
written medicines information for patients from the
information needs of patients pose a challenge perspective of patients and health professionals.
to providers of written medicines information.
Narhi, 2007 Sources of medicine information To study the medicine users sources of medicine Medicine users reported receiving medicine Finaland 3/4. Sources of medicine information and their
and their reliability evaluated by information and the perceived reliability of these sources in information from many sources. The most reliability evaluated by medicine users
medicine users different age groups. commonly used sources were perceived as the
most reliable, but their reliability did not seem
to depend on age. The counsellors should take
into account that patients have many sources of
medicine information, with varying validity.

Nemeth, 2007 Speech based Drug Information Medicine Line (MLN) is an automatic telephone information Hungary 3/4. A summary of a Speech based Drug Information
System for Aged and Visually system operating in Hungary since December 2006. It is System for Aged and Visually Impaired Persons in
Impaired Persons primarily intended for visually handicapped persons and Hungary
elderly people.

Raynor, 2007 How do patients use medicine
information leaflets in the UK?
To determine how patients use patient information leaflets Almost all patients surveyed were aware of the United Kingdom
(PILs) for prescription medicines.
2/3. Produced finsing on the use of medicines
PIL, showing that 8 years after becoming information by consumers/patients.
mandatory, the presence of the leaflets is now
being felt. It is encouraging that most read the
leaflet with the first supply, although the same
cannot be assumed for very old individuals, who
were under-represented. The fact that a
majority taking a medicine long term did not
read the leaflet again, after the first time, is a
concern. Much will have been forgotten and
some information may have changed.
Pharmacists continue to have a role in
encouraging the use of PILs.

Raynor, 2007 The importance of medicines
information for patients
Discusses the importance of spoken and written information Text-based information will remain important as United Kingdom
for patients about their treatment and suggests how current supporting information, though current
patient information leaflets can be improved. medicine leaflets need to be improved. In the
future, web-based information will allow the
more tailored information that people want,
linked to information about their condition and
other treatments.
3. (Opinion based piece). Provides a consise overview
of patient information leaflets, and their regulation in
the United Kingdom. Provides unsourced statements
providing what patients want to know about the
medicines.
Carrigan, 2008 Adequacy of Patient Information We assessed the leaflets supplied with the 50 most
on Adverse Effects frequently prescribed drugs in England, to determine the
extent to which the likelihood of adverse effects was
described, and whether it met the requirements of the EU
guidance and/or best practice.
Patient need is not being met in terms of the United Kingdom 3. Findings on the adeqaxy of medcines information
provision of usable information about the with regards to adverse effects.
likelihood of adverse effects. Most patients
receive no information, whereas some are given
verbal descriptors, both of which lead to
overestimation of the risk. Very few of the
patient information leaflets assessed used
currently described best practice, i.e. to present
verbal descriptions alongside numerical
information in the form of natural frequencies,
e.g. rare (affects less than 1 in 1000 people).

Nader, 2008 Patient sources for drug
information in Iran: A
questionnaire-based survey
To identify sources used by patients to obtain drug-related A significant portion of patients obtained Iran 3/4. Fidnings produced (in Iran) on the use of PILs
information and to find which portion of patients study the medicines without a prescription. Only a small and information received by patietns about their
Patient Information Leaflet (PIL). portion of patients in Shiraz received adequate medicines from doctors and pharmacists.
drug information from their physician or
pharmacist. A considerable portion of patients
did not study PILs

Hirsh, 2009 Patient assessment of To obtain patient feedback about the structure and quality According to people with RA, leaflets generated Australia 3. Produced findings that medicines infomration
medication information leaflets of medication information leaflets and validate the from a linguistic framework are clearer and more leaflets can be improved when applying a ELF when
and validation of the Evaluative usefulness of the Evaluative Linguistic Framework (ELF) for effective in communicating information about producing leaflets.
Linguistic Framework (ELF) improving written communication with patients. medications

Raynor, 2009 Key Principles to Guide
Development of Consumer
Medicine InformationContent
Analysis of Information Design
Texts
To identify principles from the wider discipline of
information design for use by health professionals when
developing or assessing written drug information for
patients.
Applying the good information design principles United Kingdom 3. Produced good information design prinicples.
identified to written consumer medicines
information could support health professionals
when developing and assessing drug information
for patients.

Luk, 2010 Written Medicine Information To identify, collate, and evaluate different formats of written Six English speaking 3/4.
from English-Speaking Countries medicine information (WMI). countries
How Does It Compare?

Henk Pander Improving the usability of This study assesses the usability of three patient Although the current EU regulations for patient Neatherlands 3. Fidnings on medicines information design.
Maat, 2010 patient information leaflets. information leaflets and attempts to improve them while information leaflets do not guarantee leaflet
complying with the current EU regulations. usability, the leaflets can be improved somewhat
within the regulations. However, further
research should evaluate the text structure
currently imposed on leaflets.
van der Berg, How was patient empowerment
2010 portrayed in information leaflets
describing the community
pharmacy Medicines Use
Review service in the UK?
The Medicines Use Review (MUR) community pharmacy
service was introduced in 2005 to enhance patient
empowerment but the service has not been taken up as
widely as expected. We investigated the depiction of the
patientpharmacist power relationship within MUR patient
information leaflets.
The educational role of the MUR overshadowed United Kingdom 3/4. Produced findings of patient empowerment
the intended patient empowerment that would through the use of medicines leaflets.
take place with a true concordance-centred
approach. Although patient empowerment was
implied, this was within the boundaries of the
biomedical model with the pharmacist as the
expert provider of medicines information.

Jay, 2011 User testing of consumer This article presents an overview of the design and Given CMIs role in empowering patients with Australia 2/3. Produces findings to support the claim that
medicine information in development of Australian CMI, and discusses user-testing information, it follows that every attempt should when producing medicines information "user-teting"
Australia as an iterative, formative process for CMI design. be made to ensure that they are consumer methods should be applied.
friendly and usable. There is a strong argument
that user testing should be employed in writing
medicine information.

Schwappach, Is less more? Patients
2011 preferences for drug
information leaflets
Present package information leaflets do not fulfil the needs
of many patients. The objective of this study was to
investigate patients preferences towards content and
presentation of drug information leaflets using prepared
medication brochures in a discrete choice experiment.
In general, participants preferred condensed,
plain information in a clear and moderately
coloured design, but preferences to- wards drug
information are affected by age and level of
education.
Switzerland 3. Produced findings on patients wants/requirements
for formatting stule with regards to medicine
infomration leaflets.

Hmeen- Developing a national medicines The Finnish Medicines Agency was mandated to develop a Stakeholders identified multiple strengths, Finland 3. Identified multiple strengths, challenges and
Anttila, 2012 information strategy in Finland-- national medicines information strategy. The objectives of challenges and opportunities in medicines opportunities in medicines information that were
a stakeholders' perspective on this study were to assess stakeholders views on strengths, information that were fundamental to fundamental to developing the national medicines
the strengths, challenges and challenges and opportunities in medicines information for developing the national medicines information information strategy.
opportunities in medicines the basis of the strategy. strategy. An inventory of stakeholder
information. perspectives can be recommended as a tool to
support decision-making in pharmaceutical
policy.
Dickinson, 2013 Suits you? A qualitative study To explore participants opinions and preferences on Most participants welcomed tailored leaflets but United Kingdom Produced finsings on patients opionions with regards
exploring preferences regarding tailored written medicines information. overall valued a more personalised approach to individualised taloured patient infomration.
the tailoring of consumer than the generalised tailored information.
medicines information. Despite concerns about quality and delivery,
many felt tailoring written medicines
information could improve the relevance of the
information to the individual and potentially
encourage them to value it.

Hamrosi, 2013 Its for your benefit: exploring To explore consumers beliefs and preferences for benefit Participants wanted to receive information Australia 3. Produced finsings relatinging to consumers beliefs
patients opinions about the information in medicine leaflets and examine their about the benefits of their medicines. However, and preferences for benefit information in medicine
inclusion of textual and understanding and reaction to treatment benefits. they may misinterpret the numerical information leaflets and examine their understanding and
numerical benefit information in provided. reaction to treatment benefits.
medicine leaflets

Krska, 2013 Patients Use of Information
about Medicine Side Effects in
Relation to Experiences of
Suspected Adverse Drug
Reactions: A Cross-Sectional
Survey in Medical In-Patients
The objective was to determine how patients use patient
information leaflets (PILs) or other medicines information
sources and whether information use differs depending on
experiences of suspected ADRs.
The results support the view that most patients United Kingdom 3. Fidnings suggesting that the reading of medicines
feel knowledgeable about medicines risks and information does not lead to patients experiencing
suspected ADRs and value information about suspected ADRs.
side effects, but that reading about side effects
in PILs or other medicines information sources
does not lead to experiences of suspected ADRs.

Nicolson, 2013 Good quality patient leaflets are

prerequisite to concordance
between patients and
healthcare professionals

Raynor, 2013 User testing in developing A summary of how user testing is carried out on patient United Kingdom 3/4. A summary of how user testing is carried out on
patient medication information medication infomration in Europe patient medication infomration in Europe
in Europe
Ziegler, 2013 Comprehension of the
Description of Side Effects in
Drug Information Leaflets
The German Federal Institute for Drugs and Medical Devices
(Bundesinstitut fr Arzneimittel und Medizinprodukte,
BfArM) states that it uses
standardized terms to describe the probabilities of side
effects in drug
information leaflets. It is unclear, however, whether these
terms are actually
understood correctly by doctors, pharmacists, and lawyers.
Statements about the frequency of side effects Germany 3. Produced findings on the doctors and pharmacsits
are found in all drug information leaflets. Only a undestanding of terms used in medcines leaflets.
small minority of the respondents correctly
stated the meaning of terms that are used to
describe the frequency of occurrence of side
effects, even though they routinely have to
convey probabilities of side effects in the course
of their professional duties. It can be concluded
that the BfArM definitions of these terms do
not, in general, correspond to their meanings in
ordinary language.

Hamrosi, 2014 (Bundesinstitut fr Arzneimittel To examine and compare the awareness, use and provision Consumers want and read information about Australia 2/3. Discussion between the opinions of GP,
und Medizinprodukte, BfArM) of CMI by consumers, pharmacists and general practitioners their medicines, especially when received from pharmacists and consumers, with regards to
states that it uses (GPs). their GP or pharmacist. Healthcare professionals medicines infomration.
report usually discussing CMI when providing it
to patients, although continued improvements in
dissemination rates are desirable. Regular use of
CMI remains a challenge, and ongoing strategies
to promote CMI use are necessary to improve
uptake of CMI in Australia.

Spinillo, 2014 How Do Patient Information
Leaflets Aid Medicine Usage? A
Proposal for Assessing Usability
of Medicine Inserts
There is a lack of empirical evidence on the usability of PILs Brazil 2/3. Asses the usability of medicines information
since most research has focused on their readability and leaflets, as a whole, without lookinging at formatting
legibility, and legal regulations worldwide have neglected style as a factor.
their usability aspects. Considering the importance of this
matter, the aim of this study was to assess PILs usability.

Tong, 2014 standardized terms to describe To explore consumer opinions on (i) the presentation of One single method of risk presentation in CMI is Australia 2/3. Produced findings about the consumers' want
the probabilities of side effects side-effect information in existing Australian CMI leaflets unable to cater for all consumers. Consumer for side effects to be detailed in medicines
in drug and alternative study-designed CMIs and (ii) side-effect risk misunderstandings are indicative of possible information.
information and its impact on treatment decision making. health literacy and numeracy factors that
influence consumer risk appraisal, which should
be explored further.

Bennin, 2015 But its just paracetamol: To determine whether caregivers are able to make informed Most caregivers are not able to make informed South Africa 3. Produced findings on the ability of caregivers, to
Caregivers ability to administer decisions about their families use of over-the-counter (OTC) decisions from the information provided with make infomraed decisions from medicines
over-the-counter painkillers to painkillers through access to and use of three mechanisms OTC painkillers. This is mostly attributable to information, thus correlating to health literacy.
children with the information of information provision. limited provision of information and low health
provided literacy.
Boudewyns, Influence of patient medication
2015 information format on
comprehension and application
of medication information: A
randomized, controlled
experiment
Maat, 2015 information leaflets. It is
unclear, however, whether
these terms are actually
Dickinson, 2016 understood correctly by doctors, Patient information leaflets (PILs) are required with all
pharmacists, and lawyers.
Dickinson, 2016 Do Patients Use a Headline
Section in a Leaflet to Find Key
Information About Their
Medicines? Findings From a
User-Test Study
Hameen-Antilla, Strategic development of
2016 medicines information:
Expanding key global initiatives collaboration.
To examine patients comprehension and application of
alternative versions of patient medication information
handouts for a fictitious drug, and whether patient
characteristics influence patients ability to understand the
handouts.
The structure of patient information leaflets (PILs) supplied
with medicines in the European Union is largely determined
by a regulatory template, requiring a fixed sequence of pre-
formulated headings and sub-headings. The template has
been criticized on various occasions, but it has never been
tested with users. This paper proposes an alternative
template, informed by templates used in the USA and
Australia, and by previous user testing.The main research
question is whether the revision better enables users to find
relevant information.
license medicines throughout the European Union (EU) and
they must include information about all side effects and
their likelihood. This has led to criticism of a lack of balance,
with little information included about potential benefits.
Recent European Medicines Agency guidance proposed the
inclusion of benefit information, and this study examined
the current prevalence and type of such information in PILs
in the EU.
To explore the extent to which readers used a headline
section in a PIL, using a form of diagnostic testing called
user-testing, which examines how readers find and
understand key information.
This commentary gives an example of national level
strategic development of MI, and calls for international
Both formats resulted in better comprehension United States 3. Findings on the comprehension and application of
than the MedGuide format used in the study. alternative versions of patient medication
Practice implications: Results provide valuable information handouts for a fictitious drug.
information on how to design patient
information to improve patients understanding
of the risks and benefits of the drugs they are
prescribed. Results could be extended to inform
the content of other types of patient education
materials.
Concluded that document template designs can Netherlands, United Concluded that document template designs can be
be analyzed in terms of the four parameters Kingdom analyzed in terms of the four parameters grouping,
grouping, ordering, granularity and wording. ordering, granularity and wording. Furthermore, they
Furthermore, they need to be tested on their need to be tested on their effects on information
effects on information findability, with template findability.
translations requiring separate testing. It was
found that the new patient information leaflet
template proposed here provides better
information findability.
Current PILs do not appropriately communicate United Kingdom 2/3. Produced findings about the consumers' want
information about benefit. At the basic level, for side effects to be detailed in medicines
around a half did not include information about information.
treatment rationale or whether the treatment
was to treat symptoms, curative or preventative.
However, for true informed decision making,
patients need quantitative information about
benefits and none of the leaflets provided this.
The research suggests there does not appear to United Kingdom 2/3. Findings suggesting that patients find the
be any negative impact from including a headline section in a leaflet to find key infomration
headline section in a PIL, and it is a technique valuable.
that is highly valued by the consumers of
medicines information.
Finland 3. An argument for international collaboration on the
strategic development of medicines information.
Pires, 2016 Factors influencing subjects'
comprehension of a set of
medicine package inserts
To evaluate the participants comprehension of a sample of Given that a high level of education and literacy Portugal 3. Findings suggest PIs should be clearly written to
PIs and to build an explanatory model of subjects were found to be the most relevant predictors assure that they are understood by all potential
understanding of the con- tent of these documents. for acceptable comprehension rates, PIs should users, including the less educated.
be clearly written to assure that they are
understood by all potential users, including the
less educated.

Tong, 2016 Exploring consumer opinions on To explore consumer opinions on (i) the presentation of One single method of risk presentation in CMI is Australia 3. Findings on comsumer opinions on the
the presentation of side-effects side-effect information in existing Australian CMI leaflets unable to cater for all consumers. Consumer presentation of side effects infomration.
information in Australian and alternative study-designed CMIs and (ii) side-effect risk misunderstandings are indicative of possible
Consumer Medicine Information information and its impact on treatment decision making. health literacy and numeracy factors that
leaflet influence consumer risk appraisal, which should
be explored further.