White paper
The changing landscape of consumer
medicine information: From paper to screen
Prepared for GuildLink by Optum
Introduction
Medicines are the most common treatment used in health care and, when used appropriately,
they contribute to significant improvements in health outcomes. As health treatment
regimens become increasingly complex, the use of multiple medicines is more prevalent
and the potential for medicine-related harms associated with errors and adverse events is
amplified — though the majority are preventable. The burden on patients and the health
system is considerable.
In Australia:
• 2–3% of all hospital admissions are medication related.1
• Estimates suggest an annual medication hospitalisation admission rate of 230,000 people
at a cost of $1.2 billion dollars annually.1
• 10% of patients saw a GP in the past six months for an adverse medication event.1
Written medicine information, such as Consumer Medicine Information (CMI), plays an
important role in educating patients about their medicines, improving knowledge, adherence
and understanding, reducing the potential for harm and inadvertent misadventure.
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A growing concern
The Internet is a part of everyday life in today’s world. With 83 percent of Australian
people using the Internet and 70 percent owning a smartphone or tablet,2,3 we are more
connected than ever before. The advent of the Internet has also fundamentally changed
consumers’ relationship with health information, offering new avenues for acquiring
information that previously was solely the domain of health care professionals. Recent
research shows that 72 percent of people search for health information online,4 and
this is more likely among people with chronic conditions.5 This growing trend, however,
has provided significant challenges for consumers in identifying credible information
and raised valid concerns regarding the quality and reliability of the information on
the Internet, as it is neither controlled nor standardised. Whilst considerable progress
has been made in improving transparency and accessibility to health and medicine
information through government, pharmaceutical and third-party health provider
websites, the benefit or harms to health outcomes is yet unknown.
Efforts to ensure currency and consistency in the appearance of CMI through the use of
Core CMI templates in conjunction with Usability Guidelines have made CMI an enviable
form of written medicine information worldwide.14 However, evidence suggests that
the current form of CMI does not necessarily meet the requirements of consumers and
health care professionals.
45%
of people search online
for prescription medicine
information
Source: http://www.pewinternet.
org/2009/06/11/prescription-orover-the-counter-drugs/
Medicine leaflets have not always been clearly understood by patients and their carers,
often due to complex medical language and poor visual presentation.6 Written medicine
information should have sufficient detail to meet user’s needs and be written in a tone
and language that is accessible and easily understood. The poor understanding of
information may lead to detrimental health outcomes by negatively influencing spoken
communication between patient and health care providers, and may adversely affect
adherence to therapy resulting in increased health care costs.
The value of consumer medicine information
Written medicine information such as CMI is a valuable tool in influencing
health literacy and plays a vital role in patient education and encouraging patientprovider communication.7
Studies have found:
•
Over two-thirds of consumers read CMI.8
•
CMI is an influencing factor in adherence to medicines. Patients receiving written
medicine information took the medicine as instructed more often.9
•
The CMI’s impact on knowledge may depend on a number of factors including the
quality (content, layout, design) and delivery method.10
•
Consumers find medicine leaflets too long and are likely to read and value a shorter,
more “concise” leaflet.11
However, the lack of perceived value and usefulness of CMI by health care professionals is
evident.12 This, along with a desire to protect patients from unnecessary worry over their
medicines, as well as concerns surrounding the erosion and broader impact on the patientprovider relationship, has had a negative impact on CMI provision rates. And, whilst
accessibility and availability of CMI over the past decades have increased due to changes
in legislation, policy and the Internet, a lack consumer awareness of the availability of CMI
and its rate of provision by health care professionals remains sub-optimal.
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Understanding why
At first glance, the provision and use of CMI should not be an issue. Yet, despite the
increase in the avenues of access to CMI available, a number of barriers still exist in its
provision and use13:
Consumer barriers
Health care
professional barriers
Pharmaceutical
manufacturer barriers
Rx
• Legalistic tone
• Limited time/too busy
• Not patient-focused
• Consumers not
interested
• Too long
• Confusing
• Limited awareness
• Attitude of HCP
• Lack of privacy
• Time constraints
• Literacy/language
barriers
• Regulatory
requirements
• Lack of time/resources
• Concerns about
consumer understanding
• Lack of perceived
benefit
• Too long
• No guarantee
of provision by
pharmacists
• Not available in other
languages
• Lack of consumer
demand
• Pharmacy layout/
workflow
The project: Exploring the issue
The project aimed to expand on the findings of the CMI Effectiveness Project, which
made several key recommendations relating to the further development of CMI, namely
a simpler version of CMI. As the use of the Internet by consumers is now commonplace,
the implications for the distribution and dissemination of CMI were considered. As such,
the specific objectives of the project were to:
• Review the current CMI format to produce a more succinct CMI.
• Examine whether the reviewed format CMI’s “performance” is improved.
• Examine the use of the revised CMI on a “screen”, e.g., tablet or computer.
The original sponsor-approved CMI was renamed to produce a “fake” leaflet called
“Optmed”. A revised Optmed leaflet was produced based on the original sponsor written
CMI, and re-written using best practice design and readability principles, then refined
through feedback. User testing was conducted on a target group of 20 eligible participants
for each format tested (n=60): the paper-based, sponser-based CMI and revised CMI and
the screen-based (desktop or iPad) CMI. User tests were based on the method developed
by Sless14 and the European Union (EU) Guidance on Readability Testing.15
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Project highlights
General
• Health literacy was not always correlated with higher levels of education.
Participants involved in screen (tablet or desktop) user test had higher health
literacy scores overall, compared to the paper-based testing participants.
• The changes to the reviewed CMI were positive and performed better than the
original sponsor CMI, with fewer participants experiencing difficulties or being
unable to find or understand the information.
• Co-locating of similar information and the addition of key sub-headings offered
significant improvements in finding information. It also allowed participants to
self-tailor, reading only information relevant to them personally.
• Small tweaks led to improvements in the participant’s ability to find information.
Further scope remains to incorporate improvements, particularly in relation to the
location of information about allergies.
• Clarity of wording regarding instructions on what to do if you miss a dose is
required due to the substantial variation in responses and reported actions
participants would take.
Internet (screen-based testing)
• Accessibility to medicine information online was very important to participants.
• All participants reported using the Internet either at work or at home. 70% of
participants reported used the Internet to search online for information about
medicines, predominantly when receiving a new medicine or for suspected side
effects.
• The main method Internet searching was Google, and most found it easy or
moderately easy to find information. Most were only mildly or moderately assisted
by the information they found.
• Participants generally scrolled through the document when searching for
information. Generally, participants scanned or skimmed the CMI using keywords,
sub-headings or headings to navigate and appeared speedier in locating
information in comparison to paper-based testing.
• The use of a disappearing versus static navigation menu did not increase use of the
navigation menus by participants.
• No obvious differences were observed between the use of the desktop when
compared to the tablet.
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The opportunity for change
The project findings build on the knowledge of CMI in Australia, presenting a unique
opportunity to further enhance the current CMI to reflect the changing landscape.
Building quality and value, leveraging accessibility, and raising awareness and
education surrounding CMI should be the focus when developing the strategies to
adapt to this changing environment.
Building quality and value
• A positive step towards driving further changes to CMI is the development of a
framework with the involvement of all stakeholders, providing a clear vision of the
role, value and place of CMI now and in the future.
• A standards and review committee could be formed under existing groups and
funding sought to drive the adoption of changes to the Core CMI. Revision to the
current Usability Guidelines may need to be contemplated alongside the current
regulatory framework.14
• A review of the current Core CMI incorporating key aspects of the findings of this
project and those of previous research should be considered. Core CMIs provide
consistent and regulated documents, however, these should be used critically,
within the context of the whole document. The use of Core CMI and their intent
could be reviewed as the writing of quality, usable CMI requires thought regarding
the final end-user readership of the document. Certain aspects of the medicine
and the use of sub-headings relevant and individual to the document may be
required.
A multifaceted approach
to deliver appropriate
strategies, programs and
governance to enhance
the utilisation and delivery
of CMI is essential to
facilitate change.
• Encourage pharmaceutical manufacturers to attend or develop workshops and
writing seminars to assist CMI writers in producing quality documents targeted to
the consumer; CMI that are succinct, to the point and simpler (but not simple).
• Consideration of a targeted in-house review/testing process with the involvement
of consumers when producing CMI, whether it be formalised CMI user test
processes or other internal processes to ensure consistency and quality.
Leveraging accessibility of CMI from paper to screen
• To further explore avenues of access to increase consumer and health care
professional uptake of CMI and provide further scope for health care professionals
to engage consumers with CMI.
• Stakeholder consultation, engagement and collaboration in the process
of transitioning CMI from the “leaflet” to the “screen” context would be
advantageous. The incorporation of social media, apps and other new modes of
communication should be explored and adopted to reach the broader market.
• A pilot trial in pharmacy and general practice using the reviewed CMI, including
both paper and online modes, should be implemented to determine its palatability,
practicality and sustainability in both clinical practice and with consumers. This
CMI may be disseminated to the consumer through their preferred method either
as a print leaflet, email, text, QR code, audio file or information on links to the
appropriate websites.
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• Further research into the opportunities and capabilities of providing information
to consumers via social media, the web or through cloud-based solutions in an
interactive form. Expandable terms providing further information, hyperlinks, links
to manufacturer websites, adverse drug reaction reporting (ADR) questions to ask
your health care professional, etc. As new technologies emerge, strategies to adapt
deftly and efficiently to the changing environment to ensure consumer needs are
met are essential into the future. The use of audio and video technology should be
further explored to ensure CMI is accessible to all people irrespective of literacy or
language.
Raising awareness and education through a targeted approach
• Establishment of a “Consumer Awareness and Education Sub-Committee” by the
Therapeutic Goods Administration or other relevant body. The establishment of a
standing committee would allow members to focus on coordinated and targeted
consumer awareness and education campaigns, disseminated through print and
electronic media.
Engaging stakeholders such
as consumer, professional
and government bodies in
a collaborative effort is a
crucial step for embracing
this opportunity for change.
• Promotion of websites that contain Australian CMI, for example, the Therapeutic
Goods Administration or medicines.org.au, to consumers as, although they are
readily accessible, few consumers are aware of them. The Internet web address for
these central repositories should be listed on each CMI.
• As further consolidation, health care professional education and awareness
campaigns should be promoted to remind, foster and encourage CMI use. The
campaign should focus on increasing health care professional awareness, the role
of the health care professional in CMI, the value of CMI as a tool for informationsharing and importantly, improving the attitudes of health care professionals
towards CMI. Strategies to incorporate CMI into daily practice are needed.
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References:
1. Australian Commission on Safety and Quality in Health Care (2013), Literature Review: Medication
Safety in Australia. ACSQHC, Sydney.
2. http://www.abs.gov.au/ausstats/[email protected]/Lookup/8146.0Chapter32012-13.
3. http://www.deepend.com.au/download-white-paper-device-usage-in-the-home.
4. http://www.pewinternet.org/fact-sheets/health-fact-sheet/.
5. http://www.pewinternet.org/2010/03/24/health-information/.
6. Nicolson DJ, Knapp P, Raynor DK, Grime J, Pollock K. Do themes in consumer medicines
information literature reviews reflect those important to stakeholders? Patient Educ Couns
2006;64(1-3):112-8.
7. Haynes RB. Interventions for helping patients to follow prescriptions for medications. Cochrane
Database Syst Rev 2001(Issue 1).
8. Hamrosi KK, Raynor DK, Aslani P. (2013) Pharmacist, general practitioner and consumer use of
written medicine information in Australia: are they on the same page? Research in Social and
Administrative Pharmacy 10(4):656-668.
9. Dodds LJ. Effects of information leaflets on compliance with antibiotic therapy. Pharm J
1986;236:48-51.
10. Raynor DK, Blenkinsopp A, Knapp P, et al. A systematic review of quantitative and qualitative
research on the role and effectiveness of written information available to patients about individual
medicines. Health Technol Assess 2007;11(5):iii, 1-160.
11. Koo M, Krass I, Aslani P. Consumer opinions on medicines information and factors affecting its
use-an Australian experience. Int J Pharm Pract 2002;10(2):107-14.
12. Hamrosi KK, Raynor DK, Aslani P. (2013) Pharmacist and general practitioner ambivalence about
providing written medicine information to patients - A qualitative study. Research in Social and
Administrative Pharmacy 9(5): 517-530.
13. Aslani P, Hamrosi K, Feletto E, et al. Investigating Consumer Medicine Information (CMI) Report.CMI
Effectiveness Tender. The Pharmacy Guild of Australia and Department of Health and Ageing, 2010.
14.Sless D, Shrensky R. Writing about Medicines for people in: Usability guidelines for consumer
medicine information. 3rd ed, ASMI, 2006.
15. European Commission. Directive 2004/27/EC of the European Parliament and of the Council of
31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal
products for human use., 2004.
Authors:
Dr Kim Hamrosi | Optum
Health Economics & Outcomes
Research Consultant
Asia Pacific, Life Sciences
[email protected]
Roma Cecere | GuildLink
General Manager
Strategic Business Performance
[email protected]
Prepared for GuildLink by Optum
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