investigating consumer medicine information (i-cmi)...
TRANSCRIPT
i
Investigating Consumer Medicine Information
(I-CMI) Project
Researchers:
University of Sydney, New South Wales Associate Professor Parisa Aslani Ms Kim Hamrosi Ms Eleonora Feletto University of Leeds, UK Professor DK Theo Raynor Dr Peter Knapp Graphic Design Consultant Mr Brian Parkinson
Curtin University, Western Australia Professor Jeff Hughes University of Queensland Associate Professor Lisa Nissen Linguistic Consultant Dr Alison Moore
THE RESEARCH AND DEVELOPMENT PROGRAM IS FUNDED BY THE AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH AND AGEING AS PART OF THE FOURTH COMMUNITY PHARMACY AGREEMENT
FINAL REPORT
2
FINAL REPORT
Acknowledgements The research team would like to thank the members of the CMI Effectiveness Advisory Panel for their guidance in the project:
Mr Michael Bolt (Department of Health and Ageing) Ms Jenny Bergin (Pharmacy Guild of Australia) Ms Elizabeth DeSomer (Medicines Australia) Mr John Donohue (Therapeutic Goods Administration) Ms Helen Dowling (Society of Hospital Pharmacists of Australia) Mr Peter McBeath (Pharmacy Guild of Australia) Dr Sylvia Roins (Electronic Distribution Working Group) Dr Deon Schoombie (Australian Self Medication Industry) Mr Barry Schultz (Pharmacy Guild of Australia) Mr Bill Scott (Pharmacy Guild of Australia) Ms Dimitra Tsucalas (Pharmaceutical Society of Australia) Ms Amy Zelmer (Consumer Health Forum) The research team would also like to thank the members of the I-CMI Advisory Team for their time and feedback:
Mrs Margaret Artist (National Prescribing Service) Mrs Mary Emanuel (CMI Quality Assurance Reference Group) Mrs Roma Cecere (Healthlinks.net) Dr Michelle Koo (National Prescribing Service) Mrs Anita Maberly (National Prescribing Service) Mrs Sheila Rimmer (Consumer Health Forum) Dr Margaret Williamson (National Prescribing Service) The research conducted on this project would not have been possible without the additional assistance and support of the following people:
Professor Alison Blenkinsopp Mr Elsamual (Sam) Elhebir Dr Janet Grime Ms Anthea Jones Ms Alice Luk Dr Julian Morrow Dr Donald Nicholson
Ms Pat Spoor Mr Daniel Stephenson Dr Jude Tasker Ms Natalie Tasker Dr Andrew Wearing Ms Rebecca Wegener Ms Laura Wilson
We would especially like to thank Eleonora Feletto who stepped in towards the end of the project to assist with the workflow change management plan. We would like to specifically thank Ms Erica Vowles and Ms Magda Markezic from The Pharmacy Guild of Australia for their understanding and support throughout the challenges of this project. We would also like to thank the following staff of these companies who provided their assistance and expertise:
Ms Jan Austin (J & S Research Services) Mr Jamie Cameron (CDM Call Centre) Mr Tim Cooper (Creative Data Solutions) Mr Aaron Morris (I-View Pty Ltd) Ms Emma Rowland (IPSOS Research) Dr Caroline Tomiczek (IPSOS Research) Thank you to all the consumers, general practitioners, community and hospital pharmacists, CMI writers and key stakeholders who provided their time and opinions in order to shape the future of CMI.
Lastly, thank you to the staff in the Faculty of Pharmacy office at The University of Sydney, in particular Ms Susan Putnam and the ever patient Ms Ewa Miszcak (Sydnovate, University of Sydney).
3
FINAL REPORT
Declaration of Interest DK Raynor is a Director of LUTO Research Ltd which provides health information testing services.
Ethics
Approval for the conduct of each stage of the research study was obtained from the Human Research Ethics Committee of the University of Sydney, and for Step 5 from the ethics committees of Curtin University and University of Queensland.
This report was produced with the financial assistance of the Australian Government Department of Health and Ageing. The financial assistance provided must not be taken as endorsement of the contents of this report.
The Pharmacy Guild of Australia manages the Fourth Community Pharmacy Agreement Research & Development which supports research and development in the area of pharmacy practice. The funded projects are undertaken by independent researchers and therefore, the views, hypotheses and subsequent findings of the research are not necessarily those of the Pharmacy Guild.
4
FINAL REPORT
Acronyms
Acronym Explanation
ABS Australian Bureau of Statistics
AUS Australian
CIRF Consumer Instrument Rating Form
CMI Consumer Medicine Information
CP Community Pharmacist
EDWG Electronic Distribution Working Group
EU European Union
FKGL Flesch-Kincaid Grade Level
GP General Practitioner
HCP Health Care Professional
HP Hospital Pharmacist
HREC Human Research Ethics Committee
I-CMI Investigating Consumer Medicine Information
NF Not Found
NPS National Prescribing Service
NSW New South Wales
NU Not Understood
NZ New Zealand
PBS Pharmaceutical Benefits Scheme
PI Product Information
PIL Patient Information Leaflet
PSA Pharmaceutical Society of Australia
QARG Quality Assurance Reference Group
QLD Queensland
QUM Quality Use of Medicines
S3 Pharmacist Only Medicine
S4 Prescription Only Medicine
SFL Systemic Functional Linguistics
SIMS Satisfaction with Information about Medicines Scale
TGA Therapeutic Goods Administration
TGR Therapeutic Goods Regulations
TKP Ten Key Principles
UK United Kingdom
USA United States of America
USKCC8 United States Keystone Consensus Criterion 8
UTQ User Testing Questionnaire
WA Western Australia
WMI Written Medicine Information
5
FINAL REPORT
Table of Contents Acknowledgements .................................................................................................................................................... 2
Declaration of Interest ……………………….………….. ............................................................................................. 3
Ethics ……………………….………….. ........................................................................................................................ 3
Acronyms………………………………………………………………………………………………………………………. 4
1. Introduction ............................................................................................................................................................. 6
1.1 Background of Consumer Medicine Information ............................................................................................... 6
1.2 Previous Research ............................................................................................................................................ 7
1.3 Project Aims and Objectives .............................................................................................................................. 7
2. Methodology Overview .......................................................................................................................................... 7
2.1 The Literature Review ....................................................................................................................................... 8
2.2 Collation and Evaluation of Written Medicine Information ................................................................................. 9
2.3 The Needs Analysis ........................................................................................................................................... 9
2.3.1Qualitative Stage .................................................................................................................................... 10
2.3.2 Quantitative Stage ................................................................................................................................. 10
2.4 Alternative CMI Formats .................................................................................................................................. 11
2.5 The CMI Pharmacy Trial .................................................................................................................................. 12
2.6 Workflow Change Management ...................................................................................................................... 13
2.7 Statistical Analysis ........................................................................................................................................... 13
3. Research Outcomes ............................................................................................................................................. 13
3.1 Study Participants ........................................................................................................................................... 13
3.2 Objective 1: Review and Identification of Gaps in the Literature ..................................................................... 16
3.3 Objective 2: Evaluation of WMI Formats for English-speaking Countries ....................................................... 18
3.4 Objective 3: Barriers and Facilitators to the Effective Use of CMI in Community Pharmacy .......................... 20
3.5 Objective 4: Development of Alternative CMI Formats ................................................................................... 23
3.6 Objective 5: Evaluation of Alternative CMI Formats with Consumers ............................................................. 25
3.6.1 Overview of Research Findings for CMI ............................................................................................... 27
3.7 Objective 6: Evaluation of Alternative CMI Formats in the Community Pharmacy Setting ............................. 29
3.8 Objective 7: The Optimal Delivery Format for S2 and S3 Medicines .............................................................. 32
3.9 Additional Key Findings ................................................................................................................................... 33
4. Limitations……. .................................................................................................................................................... 36
5. Conclusions………… ............................................................................................................................................ 37
Overview of Recommendations .............................................................................................................................. 37
Implementing the Recommendations .................................................................................................................... 38
References…….…… ................................................................................................................................................. 40
6
FINAL REPORT
1. Introduction
1.1 Background to Consumer Medicine Information
Over the last few years a noticeable shift in healthcare has occurred, focusing on increased patient-centred care underpinned by shared decision making or concordance between consumers and health care professionals (HCPs) regarding health decisions. More than ever consumers want to know about their medicines and their impact in order to make informed choices.
In Australia, written medicine information, known as Consumer Medicine Information (CMI) are available through various sources including HCPs and the Internet. CMI is standardised written information about prescription and pharmacist-only medicines prepared by pharmaceutical manufacturers in one or more of three formats: package inserts (found inside or attached to the medicines box); loose leaflets; and electronic (printed from the dispensary or prescribing computer). The content of CMI conforms to Schedule 12 and 13 of the Therapeutic Goods Regulations, which requires CMI to be “in English, clearly legible, written in a language easily understood by consumers and consistent with the product information (within the meaning of section 32 of the Act) of the medicinal product”
2, 3.
Pharmaceutical manufacturers have been providing CMI for prescription-only (S4 and S8) and pharmacist-only medicines since 1993 and 2004, respectively. Despite CMI being available in Australia for over 15 years, research undertaken in 2004 suggested that less than 30% of consumers received a CMI
1. The situation had not improved a
year later4. The formation of several committees such as the Electronic Distribution Working Group (EDWG) and
Quality Assurance Reference Group (QARG), along with the development and availability of Usability Guidelines and core CMI templates for CMI writers, has improved and standardised the CMI document. However, these have not resulted in a significant increase in utilisation and provision by HCPs or consumers. The introduction of remuneration for pharmacists, repeated reports and exhortations by pharmacy bodies has had little impact on increasing CMI provision. Consumers are still largely unaware of their existence. Consumer health representative bodies have lobbied heavily for action to increase consumer awareness, affecting some change.
Healthcare professionals have a duty of care to provide information to their consumers in order to ensure that they are taking their medicines correctly. The Pharmaceutical Society of Australia (PSA) in 1996 developed its first guideline Consumer Medicine Information and the Pharmacist
5 based on the original guidelines for all healthcare
professionals6, to assist pharmacists to meet their legal and professional obligations in ensuring that consumers
have the necessary information to make informed decisions and use their medicines appropriately. The guidelines note the circumstances under which a CMI should be provided, and that pharmacists should use their discretion to determine whether or not to provide a CMI. The Society of Hospital Pharmacists of Australia has also produced guidelines for the provision of CMI in hospitals
7.
Taking forward Consumer Medicine Information (CMI) to promote optimal effectiveness and best practice delivery in community pharmacy
Key Recommendations for implementation:
• Identified improvements regarding CMI layout, design, content and comprehensibility be incorporated into existing Usability Guidelines for CMI production. Core CMI to be re-evaluated.
• There should be further development and testing of a shorter summary version of CMI in conjunction with the comprehensive CMI currently available.
• A broad consumer awareness campaign promoting the availability of CMI be undertaken. • A targeted and active campaign for healthcare professionals, particularly pharmacists focussing on the
provision of CMI and its role in the continuum of care should be conducted. • A single prominent and user friendly internet based repository for all CMI should be available.
• There should be formal incorporation of CMI into healthcare professional workflow practices through
implementation of change management modelling.
• Improved opportunity for consumer consultation and input into the development of CMI.
• Performance based or user testing with consumers for all CMI produced should become standard practice. • An independent CMI document review process be incorporated to ensure and maintain quality of CMI
produced by manufacturers.
• A process for long-term evaluation of CMI and its impact on consumer quality use of medicines should be implemented.
7
FINAL REPORT
1.2 Previous Research
Funding through the Third Community Pharmacy Agreement8 resulted in a wider opportunity for availability of CMIs
to consumers when they are prescribed or dispensed medicines. However receipt and awareness of CMI remain limited. Research shows that consumers are aware of CMI, are receiving CMI from pharmacists and do read the CMI they receive
1, 9, 10. However, their understanding of what a CMI is varies, with the majority of people believing
that it is written information leaflets found inside medicine boxes9. Self-reported data indicate that between 24-82%
of consumers have received CMI1, 9, 10
, but the experience of receipt varies from simply finding the CMI in the medicine box, to receiving CMI only when requesting for it
9.
In 2003 and 2004, two surveys examining the readership and use of CMI by consumers were conducted as part of a larger study to evaluate the Medicine Information to Consumers (MIC) Program
1. The first survey was a self-
completion questionnaire distributed by pharmacists in July to October 2003 to 30 consecutive consumers to whom they provided a CMI (total n=200). From this survey, 94% of consumers (total n=200) reported receiving a computer printout CMI from the pharmacist. This high rate is most likely attributed to the fact that the provision of CMI was part of the inclusion criteria. In light of this, it is interesting to note that not all consumers who were given a CMI by the pharmacist were actually aware of it. The second survey consisted of two telephone surveys to a representative sample of 1000 Australian consumers (July 2003 and April 2004). This survey reported that 24% (July 2003) and 29% (April 2004) of consumers remembered receiving a computer printout CMI from their pharmacist sometime in the past. The study only took into account computer generated CMI printed by the pharmacist. Thus, these receipt rates may be an underestimation of the actual number of consumers who had access to CMI in its different forms.
In another CMI Study9, consumers (n=226) were shown to have variable understanding of CMI and most
commonly associated CMI with written information leaflets inside the medication box (n=142, 62.8%), a reflection of the main form of CMI available at the time of the study. The majority reported receiving a CMI on the day of the interview (n=132, 58.4%) or in the past (n=184, 81.4%), mainly as a package insert, and without the involvement of a health professional.
Several barriers have been reported in the literature with regard to the limited provision of CMI. Whilst the majority have been anecdotal, two studies identified perceived and actual barriers to CMI provision and use
9, 11. Barriers
centred on workflow issues and how CMI can be best integrated into the dispensing and counselling processes of pharmacists, as well as the CMI information content, design and format. Overall, the evidence shows that the provision of CMI is limited and that there are several barriers to its effective use.
1.3 Project Aims and Objectives
The overall aim of the project was to consolidate the findings related to the effectiveness of Consumer Medicine Information (CMI) and to substantiate the validity of anecdotal evidence in order to inform the development and evaluation of viable alternative CMI formats to be used in community pharmacy practice.
The specific objectives of the project were to:
Objective 1: undertake a review of Australian and international literature, relating to the provision of written medicine information (WMI) to consumers, focusing specifically on consumers’ needs for and expectations of information as it relates to the safety and effectiveness of their medicines.
Objective 2: identify and evaluate alternative WMI delivery formats currently used in comparable settings.
Objective 3: investigate barriers and facilitators to best practice CMI delivery, from the perspectives of prescribers, pharmacists, consumers, carers and other key stakeholders.
Objective 4: develop viable alternative CMI delivery formats for prescription and pharmacist-only medicines. Objective 5: qualitatively evaluate the new viable alternative formats with consumers.
Objective 6: evaluate up to three and two new viable alternative formats for prescription-only and pharmacist-only medicines, respectively, in a community pharmacy setting in terms of their effectiveness as a communication tool.
Objective 7: provide recommendations for optimum delivery format(s) of CMI for prescription-only and pharmacist-only medicines to allow the delivery of CMI as an effective tool for pharmacists.
2. Methodology Overview: The following report represents an overview of all stages of the study. Full details of all methods, results and discussion can be found in the Full Final Report.
The researchers developed a multi-pronged, staged research design to address the aims and objectives, and inform the design of alternative CMI formats. The staged approach aimed to access a wide range of views from
medicine information researchers, linguikey stakeholders and consumers in order to determine their opinions, needs and expectations regarding written medicine information use and delivery. The project’s broad approach souopinions of the various groups and stakeholders involved with CMI in order to produce alternative CMI formats that would ultimately better address the needs of the end providers and users. The research was divided isteps (Figure 1), each with specific objectives, with outcomes of each stage informing subsequent stages
1. A review of the literature from 1970 to 2008 pertaining to Consumer Medicine Information and other forms of written medicine information
2. The identification, collation and evaluation of different forms of medicine information used in community pharmacy both nationally and in English speaking countries
3. Assessing the needs of the providers and users of CMI: (a) qualitative research with healthcare professionals, consumers, CMI writers and key stakeholders regarding medicine information needs; (b) quantitative surveys of healthcare professionals and consume
4. The development, design and testing of viable alternative CMI formats (Alternative CMI Formats)5. The evaluation of new alternative CMI formats in community pharmacy (CMI Pharmacy Trial)
Figure 1. Key stages of the project
2.1 The Literature Review
The research team conducted a review of the provided to consumers within community pharmacy practice. Specifically the review examined the following areas:
• The role and value of written informationperspectives of patients themselves, carers and
• The effectiveness of written information available to patients about individual medicines in ipatients’ knowledge and understanding of treatment, and improving selfoutcomes.
• The barriers and facilitators to, firstly, the provision of health care professionals; and secondly, the use of
The reviews on the role and value, and effectiveness were undertaken on two occasions 2004 and Sept 2004 to June 2008. The role and value review built utwo of the researchers on the I-CMI Project (Grime et al 2007). barriers and facilitators was undertaken on one occasion and limited to the publication dates o
The databases searched were: CINAHLReviews, DARE, HTA database NHS EED)Consortium, Index to Theses, ISI Proceeof Science. Representatives from national and Australia were asked regarding relevant unpublished research. This route identified no additional studies.
FINAL REPORT
medicine information researchers, linguistic and information design experts, as well as healthcare professionals, in order to determine their opinions, needs and expectations regarding written
medicine information use and delivery. The project’s broad approach sought to bring together the expertise and opinions of the various groups and stakeholders involved with CMI in order to produce alternative CMI formats that would ultimately better address the needs of the end providers and users. The research was divided i
, each with specific objectives, with outcomes of each stage informing subsequent stages
review of the literature from 1970 to 2008 pertaining to Consumer Medicine Information and other forms of written medicine information available in community pharmacy practice (Literature Review).
and evaluation of different forms of medicine information used in community pharmacy both nationally and in English speaking countries (Collation and Evaluation).
ssessing the needs of the providers and users of CMI: (a) qualitative research with healthcare professionals, consumers, CMI writers and key stakeholders regarding medicine information needs; (b) quantitative surveys of healthcare professionals and consumers (Needs Analysis).The development, design and testing of viable alternative CMI formats (Alternative CMI Formats)The evaluation of new alternative CMI formats in community pharmacy (CMI Pharmacy Trial)
The research team conducted a review of the published and grey literature relating to CMI and other forms of WMI provided to consumers within community pharmacy practice. Specifically the review examined the following areas:
written information available to patients about individual medicines from the of patients themselves, carers and healthcare professionals.
of written information available to patients about individual medicines in ipatients’ knowledge and understanding of treatment, and improving self-management of illness and health
to, firstly, the provision of WMI to consumers by pharmacists health care professionals; and secondly, the use of WMI by consumers.
on the role and value, and effectiveness were undertaken on two occasions The role and value review built upon a systematic review completed in 2004 by
CMI Project (Grime et al 2007). The search for published and grey literature on the barriers and facilitators was undertaken on one occasion and limited to the publication dates o
CINAHL, Cochrane Library (CENTRAL, Cochrane Database of Systematic Reviews, DARE, HTA database NHS EED), Digital Dissertations, EMBASE, Health Management Information
ISI Proceedings, MEDLINE, Pharmline, PsycINFO, Sociological Abstractspresentatives from national Patient/Consumer Organisations and other relevant bodies in the UK
relevant unpublished research. This route identified no additional studies.
Step 1: Literature Review
Role and Value
Effectiveness
Barriers & Facilitators
Step 2: Collation and Evaluation
Collate Existing WMI
Consumer Instrument Rating Form
Functional Linguistic Evaluation
Step 3: Needs Analysis
Qualitative - Focus Groups and
Questionnaires
Quantitative - Mail surveys
Step 4: Alternative CMI Formats
Development and Design of CMI
User Testing
Step 5: The CMI Trial
Evaluation in Community Pharmacy
Workflow Change Management
Recommendations
Final Report
8
FINAL REPORT
healthcare professionals, in order to determine their opinions, needs and expectations regarding written
ght to bring together the expertise and opinions of the various groups and stakeholders involved with CMI in order to produce alternative CMI formats that would ultimately better address the needs of the end providers and users. The research was divided into five key
, each with specific objectives, with outcomes of each stage informing subsequent stages:
review of the literature from 1970 to 2008 pertaining to Consumer Medicine Information and other forms (Literature Review).
and evaluation of different forms of medicine information used in community (Collation and Evaluation).
ssessing the needs of the providers and users of CMI: (a) qualitative research with healthcare professionals, consumers, CMI writers and key stakeholders regarding medicine information needs; (b)
rs (Needs Analysis). The development, design and testing of viable alternative CMI formats (Alternative CMI Formats) The evaluation of new alternative CMI formats in community pharmacy (CMI Pharmacy Trial)
CMI and other forms of WMI provided to consumers within community pharmacy practice. Specifically the review examined the following areas:
available to patients about individual medicines from the
of written information available to patients about individual medicines in improving management of illness and health
to consumers by pharmacists and/or other
on the role and value, and effectiveness were undertaken on two occasions - from 1970 to September pon a systematic review completed in 2004 by
The search for published and grey literature on the barriers and facilitators was undertaken on one occasion and limited to the publication dates of 1970 to June 2008.
Cochrane Library (CENTRAL, Cochrane Database of Systematic Health Management Information
Sociological Abstracts and Web Organisations and other relevant bodies in the UK
relevant unpublished research. This route identified no additional studies.
9
FINAL REPORT
A total of 79,595 references were retrieved from database searches relevant to the role and value, and effectiveness review (of which 50,927 were from 1970–Sept. 2004, and 29,468 were from Oct. 2004-June 2008). A further 137 and 4,674 were identified through citation searching. The initial search strategy for literature related to barriers and facilitators yielded 27,322 references with 1,108 retained for critique. Following a complete appraisal by two independent reviewers, a total of 36 papers (from 35 studies) relating to role and value, 52 trials (from 42 papers) relating to effectiveness, and 8 papers relating to barriers and facilitators were included in the review.
2.2 Collation and Evaluation of Written Medicine Information
The aim of this stage was to identify, collate, evaluate and analyse the different forms of WMI (electronically generated and other) available for prescription and pharmacist-only medicines used in community pharmacy in six English-speaking countries (Australia, New Zealand, USA, Canada, Ireland and the UK), from the following perspectives: researcher, consumer and linguistics. English-speaking countries were selected as firstly, Australia’s main language is English, secondly, the evaluation tools available have been validated for English WMI documents, and thirdly language can impact style and how a document is written.
Researcher (Evaluation Criteria)
A total of 157 WMI documents for 10 prescription and 3 pharmacist-only medicines were collated. The WMI were evaluated using the US Keystone Consensus Criterion 8 (USKCC8)
12 and the Ten Key Principles (TKP) for CMI
13
that focus specifically on format and design of WMI. Readability was measured using the Flesch-Kincaid Grade Level (FKGL) and Fog tests. The results have been recently published
14, and are included in the full report.
Consumers (Consumer Instrument Rating Form)
The Consumer Information Rating Form (CIRF)15
, a validated survey instrument used to evaluate WMI from the consumers’ perspective, was used to assess a sample of 14 of the 157 WMI collated. The selected sample was based on the commonly prescribed medicines simvastatin, perindopril and metformin. A total of 700 survey packs were distributed in 76 pharmacies in the Sydney Metropolitan area.
Linguistic (Systemic Functional Linguistic Methods)
A Systemic Functional Linguistic (SFL) approach was used because it provided a well tested method for bringing changes in language, meaning and context into the one analytical frame
16, 17. The CMI and WMI for Lipitor
® was
reviewed using key SFL concepts of:
- ideational, interpersonal and textual function of the language - the levels of organisation in the language used - system (how language works via interacting sets of choices), instance (how a particular text case sits in
relation to other similar events) and register (the influence of writer and reader expectations of purpose and interpretation)
- empirical linguistics
Initial analysis of the CMIs and WMIs involved grammatical, lexical, formatting and discourse analytic techniques. Each section of the Lipitor
® CMI was reviewed and specific recommendations made to clarify conflict of findings
regarding meaning and purpose. The preliminary suggestions and recommendations from this analysis were used in the initial development stage of the alternative CMI formats. All final recommendations were adopted in the development of the new alternative CMI formats and evaluated in the User Testing.
2.3 Needs Analysis
The objective of the Needs Analysis stage was to explore and capture the opinions of consumers, HCPs and key stakeholders in regards to the provision and use of CMI in order to clarify anecdotal evidence and add depth to current evidence. Specifically the Needs Analysis aimed to:
• qualitatively evaluate the different forms of WMI collated from English-speaking countries. • identify and qualify barriers and facilitators to the effective use of CMI in community pharmacy practice. • identify consumers’ needs and expectations of medicine information related to the quality use of medicines. • identify the work activity required to improve the use of CMI.
The Needs Analysis step was conducted in two stages: a qualitative stage consisting of primarily focus group discussions, followed by a quantitative stage (national telephone surveys with consumers and mail surveys with healthcare professionals), to quantify and prioritise the barriers and facilitators, as well as consumers’ needs and expectations.
10
FINAL REPORT
2.3.1 Qualitative Stage
The qualitative stage consisted primarily of focus groups conducted over a period of 6 weeks (Oct-Nov 2008) in both metropolitan Sydney and rural areas of New South Wales (NSW). Participants were recruited from the following groups: consumer and carer, prescriber, hospital and community pharmacist and CMI writers from pharmaceutical companies. Key informants and stakeholders were requested to respond to the interview protocol in writing. This stage included:
- Eight consumer focus groups (n=62) - Four general practitioner (GP) focus groups (n=32) - Four community pharmacist focus groups (n=29) - One hospital pharmacist focus group (n=7) - One CMI writer focus group (n=7) - Thirty six key stakeholder written responses
Consumers were recruited through a market research company. The sample included a broad spectrum of consumers and carers with varying ethnic backgrounds, age, education, income and chronic illnesses.
Community pharmacists were recruited via mail or fax from the list of pharmacies maintained by the Pharmacy Board of NSW and through the Pharmacy Guild of Australia (NSW Branch). Hospital pharmacists were recruited from a list of major Sydney metropolitan hospitals by invitation through the Director of Pharmacy. GPs were either recruited by the market research company, or the researchers from a random sample selected from the Yellow Pages 2008, and contacted by mail or fax.
CMI writers were recruited from major pharmaceutical companies in the Sydney metropolitan area. An invitation to participate was emailed to the Regulatory Affairs Department or relevant person of the companies.
Key stakeholders were identified through either the project’s Chief Investigator who has been involved in CMI research since its inception in 1994, or through members of the project’s Advisory Team. In addition to the key stakeholders, eleven individuals were contacted, who had an interest or experience in CMI. A full list of representative groups and organisations contacted is attached (Appendix 1).
All subjects (except key stakeholders) completed a Consent Form and Subject Demographic Survey prior to the commencement of the focus groups. A semi-structured focus group discussion guide (Appendix 2) was developed to address the study aims outlined above. CMI and other WMI collated from English-speaking countries were provided during the focus groups to elicit opinions about format and design. Two researchers from the University of Sydney conducted each focus group.
All focus group discussions were audio recorded, with permission, and transcribed verbatim. Qualitative data were analysed using thematic content analysis- the transcripts and notes were reviewed to identify patterns or themes. Each of these major themes was then explored further for sub-themes. Suitable quotes illustrating the themes and sub-themes were noted. Each of the transcripts was coded independently by at least two researchers.
2.3.2 Quantitative Stage
Following the qualitative focus groups and mail feedback from key stakeholders, the quantitative stage of the Needs Analysis was conducted in order to quantify and prioritise the barriers and facilitators identified in the qualitative stage, as well as consumers’ needs and expectations with regard to medicine information, and specifically CMI. This stage consisted of two phases conducted nationally in conjunction with each other:
Phase 1: Mail Surveys with GPs and Pharmacists:
In order to detect the proportion of community pharmacists providing CMI, based on earlier provision data, and a response rate of 30%, a total sample size of 1046 (rounded to 1100) community pharmacists was required. There are no published data on the proportion of hospital pharmacists or GPs providing CMI. However based on sample size calculations, assuming a 30% and 20% response rate, respectively, a total of 600 and 1000 (rounded to 1100 to match community pharmacists) participants, respectively, were required. All participants were stratified by state.
The surveys (Appendix 4 and 5) were developed based on earlier research, and investigated CMI knowledge, current provision and use, experience, future use, content, format, and subject demographics. Slight modifications were made to the content to customise the surveys to the sample of GPs, hospital and community pharmacists.
Survey forms were posted to a random sample of GPs, community pharmacists and hospital pharmacists whose addresses had been obtained through the lists maintained by the Australian Medical Publishing Company. Postcards advising of the survey were sent out initially. A week later surveys were mailed out to all potential participants, together with a cover letter outlining the program and the purpose of the survey, as well as a reply paid envelope to return the completed survey. A competition to win one of ten 2009 Australian Medicines Handbooks was included as an incentive to complete the survey. A Thank you/Reminder was sent out after 2 weeks, and a further survey pack was sent out to non-responders 4 weeks after the initial mail out.
Phase 2: Computer Assisted Telephone Interviews (CATI) with Consumers:
A survey of 1000 consumers in a previous studysome point in the past. In order to provideconsumers was surveyed in this phase, stratified by state.conduct the telephone interviews with the consumers
2.4 Alternative CMI Formats
The objectives of this stage were to develop viable alternatimedicines, taking into consideration the presentation, length, content, readability, usability, and legal implications of the different forms. This stage was broken up into two phases:
Phase 1: Development and Design
The development and design of the new CMI formats involved several st
Assessment of the Collation and Evaluation stage
The key findings were reviewed and summarised of WMI, and used to inform the development of the alternative
Selection of the choice of medicines to be used in the alternative formats
The final decision on the medicines for which Effectiveness Tender Advisory Panel set up by the Pharmacy Guild of Australia. The PMersyndol
® would be the most suitable
Review of key principles of information design
The information design specialist led the development of the alternative CMI applying principles of good document practice including those referred to by
Needs Analysis with consumers, HCPs, CMI writers and key stakeholders
The results from the Needs Analysis were reviewed, and the main themes identified were summarised to form a brief (Appendix 3) for the information design expert. This brief gave an overview of the of consumers, HCPs and key stakeholders on the preferred econsistency of design, layout and formatting.
Review and Analysis of CMI
The initial project aim was to produce alternative content and wording changes. However, after reviewing the results of the Needs Analysis, it became the alternative CMI required rewriting, focusingcontent, accuracy and relevance of the medicine and disease in
The CMI for both Lipitor® and Mersyndol
Plain English techniques. The wording changes ensure the meanings were not lost in the rewording and reformatting of the documents. Repetition of the information was removed or reduced where possible
Phase 2: User Testing
The primary objective of conducting user testing is to determine whether important information can be easily located in the WMI leaflet by the consumer, and whether this information can be interpreted is essentially an iterative 4-step process
To ensure that participants were representative of the general population of likely users of the medicine being tested, each round of ten consisted of a sampling of:
• Age: minimum of one person in each
Interviews
• 10 Participants
• 15 Questions (UTQ)
• Test ability to find & understand information
Results
• Responses are timed
• Consumer feedback elicited
FINAL REPORT
isted Telephone Interviews (CATI) with Consumers:
consumers in a previous study1 showed that 18% of consumers had reported receiving CMI at
some point in the past. In order to provide ease of comparison between the two studies, , stratified by state. A market research company was commissioned to
conduct the telephone interviews with the consumers.
Alternative CMI Formats
develop viable alternative CMI formats for prescription and pharmacisttion the presentation, length, content, readability, usability, and legal implications of
This stage was broken up into two phases:
Development and Design
The development and design of the new CMI formats involved several steps:
Assessment of the Collation and Evaluation stage
and summarised with respect to readability, comprehensibilityused to inform the development of the alternative CMI formats.
the choice of medicines to be used in the alternative formats
for which alternative CMI were to be developed, was Effectiveness Tender Advisory Panel set up by the Pharmacy Guild of Australia. The Panel a
would be the most suitable S4 and S3 medicine, respectively, due to high dispensing volumes.
Review of key principles of information design
d the development of the alternative CMI formats for Lipitorapplying principles of good document practice including those referred to by Raynor and Dickinson
nalysis with consumers, HCPs, CMI writers and key stakeholders
nalysis were reviewed, and the main themes identified were summarised to form a brief (Appendix 3) for the information design expert. This brief gave an overview of the identified of consumers, HCPs and key stakeholders on the preferred elements of WMI. Emphasis was placed on consistency of design, layout and formatting.
alternative CMI formats focusing on the design and layout, without clinical However, after reviewing the results of the Needs Analysis, it became
, focusing on wording changes only. No changes were made to the clinical content, accuracy and relevance of the medicine and disease information included in the CMI.
and Mersyndol® were reviewed by pharmacists and medicine information experts using
wording changes were made in parallel with the linguistics recommendations were not lost in the rewording and reformatting of the documents. Repetition of the
or reduced where possible. Changes were consistent across the full and summary CMIs.
nducting user testing is to determine whether important information can be easily leaflet by the consumer, and whether this information can be interpreted
step process (Figure 2):
To ensure that participants were representative of the general population of likely users of the medicine being round of ten consisted of a sampling of:
in each decade between 30 - 70-plus (Lipitor®) and 20
Responses are timed
Consumer feedback elicited
Analysis
• Strengths and Weaknesses of document identified
• Guide modifications
11
FINAL REPORT
showed that 18% of consumers had reported receiving CMI at a sample of 1000
company was commissioned to
ve CMI formats for prescription and pharmacist-only tion the presentation, length, content, readability, usability, and legal implications of
respect to readability, comprehensibility, format and design
to be developed, was made by the CMI anel agreed that Lipitor
® and
due to high dispensing volumes.
formats for Lipitor® and Mersyndol
®,
Raynor and Dickinson18
and Sless19
.
nalysis were reviewed, and the main themes identified were summarised to form a identified information needs
lements of WMI. Emphasis was placed on
formats focusing on the design and layout, without clinical However, after reviewing the results of the Needs Analysis, it became evident that
on wording changes only. No changes were made to the clinical formation included in the CMI.
were reviewed by pharmacists and medicine information experts using he linguistics recommendations to
were not lost in the rewording and reformatting of the documents. Repetition of the he full and summary CMIs.
nducting user testing is to determine whether important information can be easily leaflet by the consumer, and whether this information can be interpreted correctly. User testing
To ensure that participants were representative of the general population of likely users of the medicine being
) and 20 - 70-plus (Mersyndol®)
Modification & Re-testing
• Document problems addressed
• Further round of new participant testing
12
FINAL REPORT
• Gender: minimum 3 participants of each gender • Education: no more than 3 higher education graduates (based on ABS statistics
20)
• Literature use: at least 2 participants who either do not use written documents as part of their work, or who are currently not working or retired
The development of the user testing questionnaires (UTQ) involved determining the key information that is important for the safe and effective use of the medicine by consumers. This involved reference to various clinical medicine information sources such as Micromedex, the Australian Medicines Handbook and the medicine’s Product Information. Two registered pharmacists on the research team reviewed the key points identified.
The purpose of the questions in the UTQ was to mimic real life situations and reflect possible questions or concerns that an actual user may have. The questions themselves focused on three main areas:
• Facts e.g. Dose; what the medicine is for? • Actions required e.g. what action would you take if you missed a dose? • Explanations of action or outcome e.g. Why can’t you drive while taking this medicine?
The questions were also chosen from each of the main sections of the CMI, to give appropriate coverage. The fifteen questions (Appendix 6) produced were reviewed by at least two other members of the research team. The questions were pilot tested on five participants and changes made based on their feedback. The majority of the questions for each CMI format were identical however some questions were substituted for others where there were specific format or wording variations in the CMI format e.g. boxed contact information.
Participants were recruited though a leaflet drop within the area surrounding the University of Sydney. Interviews were conducted at the University of Sydney by trained interviewers and participants were paid $40 for their time. Interviews lasted approximately 30 to 45 minutes. All interviews were conducted on specialised purpose-built computer software, which recorded locator success (whether subjects located the information), locator time (time taken to locate the information) and comprehension (whether consumers clearly understood the information). Scoring was based on well defined criteria as set out in ‘Writing about Medicines for People’
21 and the protocol for
the European Union (EU). An overall leaflet pass constituted that 90% of subjects tested were able to locate the requested information in the leaflet, of which 90% were able to understand the information with an overall pass mark of 81% or more. Greater sensitivity was applied to the testing process through additional time-related outcome measures, in order to identify problem areas for review and modification.
2.5 The CMI Pharmacy Trial
The primary outcome of this stage was to evaluate the effectiveness of the CMI formats as a communication tool. Other outcomes were, pharmacist and consumer satisfaction, opinions about the formats, how CMIs were used in counselling, and consumers’ self-reported behaviour after reading CMI.
Based on the results of the user testing and taking into account the desirable characteristics that were identified in the Needs Analysis, five alternative CMI formats were selected to be used in the pharmacy trial: three CMI (two comprehensive and one summary version) for Lipitor
® (Appendix 7-9) and two CMI (one comprehensive and one
summary version) for Mersyndol® (Appendix 10-11). The formats were labelled as Patient Medicine Information and
contained a disclaimer so as not to be confused with the existing CMI. Consumers were informed that they can request an official CMI if they wanted to as well.
The trial was conducted using a staged, repeated-measures approach, with consumer data collected on recruitment in the pharmacies (baseline) and at time points 5-9 days and 4 weeks post-baseline (for 20% of sample) for each cycle, by telephone. The design allowed for comparison between all alternative CMI formats, and the existing CMI. The five alternative CMI formats were assessed in 50 community pharmacies across three states: New South Wales (NSW), Western Australia (WA) and Queensland (QLD). Ten pharmacies were recruited for each of the study groups (a total of 20 in NSW, 20 in WA and 10 in QLD). In NSW and WA the pharmacies were randomised into Lipitor
® or Mersyndol
® groups according to the number of units of Mersyndol
® and Lipitor
®
sold/dispensed in the pharmacy in the month of September 2009. The recruitment targets were:
• Lipitor® - 36 consumers (12 per cycle) = total of 1080 consumers
• Mersyndol® (NSW and WA only) - 30 consumers (10 per cycle) = total of 600 consumers.
The initial and follow-up consumer telephone surveys (Appendix 12 and 13) were developed using results from the Needs Analysis and incorporating previously tested and validated surveys, including the CIRF
15, Satisfaction with
Information about Medicines Scale (SIMS)22
, Morisky23
scale and health literacy surveys24, 25
. Pharmacists’ surveys were developed to measure how CMI was used in counselling. The pharmacist surveys were not validated.
Consumers who were taking Mersyndol® or Lipitor
® were approached at random by the pharmacist or pharmacy
staff and provided with information about the study then asked to participate. Consenting participants competed a
13
FINAL REPORT
consent form, and demographic survey (Appendix 14). The consumers received either the existing CMI or a new alternative format CMI leaflet about their medicine (Mersyndol
® or Lipitor
®) to read at home.
A market research company conducted CATI surveys with all consumers at the above two time points. Self-reported data were collected from pharmacists using a survey (Appendix 15) which recorded CMI provision and use in counselling, and opinions about the CMI formats. Pharmacists were asked to complete an online qualitative feedback survey at the end of the study. Pharmacies were reimbursed $300 for their participation in the study.
2.6 Workflow Change Management The initial Tender document stated that pharmacy workflow strategies to optimise the provision and use of CMI in community pharmacy practice would be evaluated in the Pharmacy CMI Trial. Prior to the commencement of the CMI Trial, the workflow consultant who was to review and analyse the data obtained from the Needs Analysis and provide strategies for workflow management, ceased to be part of the project. A replacement expert was employed however, the implementation of the workflow strategies were not complete in time for assessment in the CMI Trial.
2.7 Statistical Analysis
IPSOS Research performed the statistical analysis on all CATI and quantitative surveys. All data collected were entered into, and analysed using the Statistical Package for the Social Sciences. Descriptive statistics were compiled for all quantitative data. Data were compared using a two-group independent t-test or equivalent (for non-parametric data sets). Chi-squared analysis was conducted to compare independent proportions. The a priori level of significance was set at 5%. Logistic regression was used to investigate relationships between outcomes.
3. Research Outcomes:
3.1 Study Participants
The participant data, demographics and sampling for each study step are explored further below.
Consumer Instrument Rating Form (CIRF)
A total of 68 consumers responded to the CIRF survey distributed through 76 pharmacies across the Sydney Metropolitan area. The low response rate and small sample size per WMI prevented robust analysis and realistic conclusions to be drawn from this stage of the study. Additionally, modification to the original Tender to incorporate User Testing as a more appropriate method of assessing CMI performance had been implemented. As a result, this stage did not play a significant role in the overall project, and was superseded by the User Testing.
Needs Analysis
Focus Groups
A total of 18 focus groups were conducted. The consumer focus groups included a range of subjects with varying age, gender, education and ethnic backgrounds in order to provide a wide scope of opinions. The pharmacists and GP focus groups were drawn from a random sample and it is likely that participants self-selected based on interest in WMI. The demographic characteristics for these groups are presented in Table 1. No demographic data are available for CMI writers. It should be noted that for qualitative studies the sample is not intended to be random or generalisable to the population of consumers, healthcare professionals, or stakeholders. Qualitative data are hypothesis generating rather than testing.
Key Participant Data:
• A total of 68 consumers from 76 pharmacies evaluated WMI using the CIRF.
• A total of 62 consumers, 32 GPs, 36 pharmacists and 7 CMI writers participated in the focus groups (Needs Analysis).
A further 36 individuals and organisations completed the Needs Analysis feedback questionnaire.
• A total of 1000 CATI consumer respondents, 349 community pharmacists, 170 hospital pharmacists and 180 GPs
completed the Needs Analysis quantitative surveys.
• A total of 120 consumers participated in the user testing interviews, evaluating the alternative CMI formats.
• A total of 551 CATI consumers and 54 pharmacies across three states (NSW, WA, and QLD) participated in the trial
evaluating five alternative CMI formats.
14
FINAL REPORT
Table 1. Focus group participant demographics (Pharmacist, General Practitioner and Consumer)
Participants Gender %
Country of Birth %
Language Spoken at Home
Avg Hrs Work/Week
Education Level % (Valid)
M F Australia Overseas English Other Post Grad
Bachelor Diploma or Cert
High School
Consumers 38.7 61.3 74.2 25.8 95.2 4.8 N/A 5.4 17.6 12.3 64.9 General Practitioners
56.3 43.8 46.9 53.1 75 25 42.5 78.2 21.9 N/A
Community Pharmacists
37.9 62.1 51.7 48.3 82.8 17.2 42.5 13.7 82.6 3.4
Hospital Pharmacists
14.3 85.7 57.1 42.9 71.4 28.6 35 14.3 71.5 14.3
Telephone (CATI) and Mail Surveys
The number of CATI participants was stratified geographically (Table 2). The proportions per state were selected to match ABS 2008
26 data in order to be representative of the Australian population based on age, gender and
geographic location. The response rate for the CATI survey was 32% over the survey period of 23 Feb to 15 March 2009. The CATI respondents’ tertiary education levels were higher than ABS data (May 2008) as more than one third were tertiary educated.
Table 2. Geographic Strata of CATI Participants Table 3. CATI Respondents Highest Education Level
The majority of CATI participants were aged between 46 and 75 years (Table 3). The majority of HCPs who responded to the mail survey were aged between 46 to 55 years (Table 4).
Table 3. Age of CATI, Community Pharmacists, Hospital Pharmacists and General Practitioner Participants
Age CATI Participants Community Pharmacists Hospital Pharmacists General Practitioners
N % total N % total N % total N % total
<25 20 2 24 7 7 4 0 0
26-35 60 6 77 22 36 21 12 7
36-45 100 10 63 18 31 18 45 25
46-55 230 23 94 27 56 33 57 32
56-65 250 25 59 17 34 20 48 27
66-75 220 22 24 7 5 3 11 6
>76 110 11 4 1 1 1 7 4
Refused 10 1 4 1
TOTAL 1000 100 349 100 170 100 180 101 Table 4. Gender of CATI, Community Pharmacists, Hospital Pharmacists and General Practitioner Participants
Gender CATI Participants Community Pharmacists Hospital Pharmacists General Practitioners
N % total N % total N % total N % total
Male 484 48.4 158 45.3 117 68.8 87 48.3
Female 516 51.6 189 54.2 53 31.2 93 51.7
Missing Data 0 0 2 0.5 0 0 0 0
Total 1000 100 349 100 170 100 180 100
State or Territory
CATI Participants
Metro Non Metro
Total N % total
NSW 215 126 341 34.1
VIC 180 76 255 25.5
QLD 77 96 173 17.3
WA 70 25 95 9.5
SA 61 23 84 8.4
TAS 10 16 26 2.6
NT 9 0 9 0.9
ACT 17 0 17 1.7
Total No. 639 362 1001
% Total 63.9 36.2
Highest Level of Education
Relative Frequency (%)
ABS Education Data 2008 (%) Aged 15-64
School year 10 or below
26 31
School year 11 or 12 27 30
TAFE or Certificate I-IV
10 16
Tertiary (Diploma, Bachelor or Higher)
37 23
Refused to respond 1
Total 1000 100
15
FINAL REPORT
User Testing A total of 10 participant interviews per CMI format tested, were completed. Subject inclusion criteria were met, and subjects were recruited across the inclusion categories. The results of two participants had to be excluded, one for literacy and inability to complete the user testing, and the other for being under the influence of a mind-altering substance. Table 5 illustrates the demographics of the participants per CMI format user tested. Table 5. Demographic Data for User Testing Participants
Lipitor®
Mersyndol®
CMI Version
Original
Rewritten
RED 3
I-CMI 1
I-CMI 3
I-CMI 4
I-CMI 6
I-CMI 7 Original
Rewritten
I-CMI 2
I-CMI 5
Gender % Fem 60 60 50 60 50 50 60 70 60 60 70 60 Male 40 40 50 40 50 50 40 30 40 40 30 40 Education % 1 40 10 20 10 10 30 30 20 20 10 10 20 2 30 60 50 60 60 40 40 50 50 60 60 50 3 30 30 30 30 30 30 30 30 30 30 30 30 Literature Use % Yes 30 40 20 40 50 30 30 40 50 40 50 30 No 70 60 80 60 50 70 70 60 50 60 50 70 Age % <30 10 20 10 20 30-39 40 10 10 10 10 20 20 20 10 10 10 10 40-49 10 20 20 20 30 10 20 10 10 10 10 10 50-59 30 40 10 30 30 20 30 30 20 30 30 30 60-69 10 20 40 30 20 40 20 30 30 10 30 20 >70 10 10 20 10 10 10 10 10 20 20 10 10 Note: CMI Version Alternative CMI format selected for user testing; numbering refers to format developed in Design and Development Stage
Education: 1 = Educated up to Year 10; 2 = Higher School Certificate or equivalent; 3 = Tertiary educated (Bachelor degree, Diploma or above)
Use of literature: Yes = regularly uses written documents in their work No = does not use written documents in their work, or is unemployed or retired
The CMI Pharmacy Trial A total of 71 pharmacies in the three states expressed interest in participating in the study, with 55 confirming their participation. Table 6 presents participating pharmacies’ demographic data for each study arm. Reasons for not participating included change of ownership, management or pharmacist who expressed interest initially, low dispensing numbers or the pharmacist changed their mind. The total number of participating community pharmacies was n=35 (Lipitor
®) and n=19 (Mersyndol
®) for the Trial. One pharmacy in the Mersyndol arm pulled
out in the first week of the trial. Attempts at finding a replacement in the short time frame were unsuccessful.
Table 6. Demographic data for participating Pharmacies
Variables LIPITOR®
n= 35 MERSYNDOL®
n= 19
PhARIA* 1 2 3 4 5 1 2 3 4 5
N 27 2 3 1 2 15 3 1 % 77.1 5.7 8.6 2.9 5.7 78.9 15.8 5.3 0 0 Pharmacy Size
<100 script/day
100-150 script/day
151-200 script/day
201-250 script/day
>250 script/day
<100 script/day
100-150 script/day
151-200 script/day
201-250 script/day
>250 script/day
N 2 13 6 9 5 1 5 5 2 6 % 5.7 37.1 17.1 25.7 14.3 5.2 26.3 26.3 10.5 31.6 QCCP / Other
Accred Not Accred
Mirixa PMP Accred Not Accred
Mirixa PMP
N 33 2 21 25 19 14 11 % 94.3 5.7 88.6 71.4 100 73.7 57.9 Type / Location
Independ Banner Strip Shop Centre
Stand alone
Independ Banner Strip Shop Centre
Stand alone
N 22 13 25 6 5 11 8 7 10 2 % 62.9 37.1 71.4 17.1 14.3 57.9 42.1 36.8 52.6 10.5 Pharmacist per shift
1 2 3 1 2 3
N 23 9 3 9 9 1 % 65.7 25.7 8.6 47.4 47.4 5.2 *Pharia 1 = Urban; 2-3 = Regional; >3 = Rural (www.gisca.adelaide.edu.au/projects/pharia_0910/PhARIA_info.html (Accessed 280110 1pm))
More than three quarters of the sample were born in Australia (Table 7). There was an almost equal proportion of males and females, and most were over 50 years in the Lipitor
® arm, whilst the majority of the sample were
females and of various ages in the Mersyndol® arm. This reflects the users of Lipitor
® and purchases / users of
Mersyndol®, and is not necessarily a representative sample of the general Australian population.
16
FINAL REPORT
Table 7. Consumer Demographic Data for participating Consumers
Variable Lipitor®
(n=382) Mersyndol®
(n=169)
N % total N % total
Gender Female 208 54.5 139 82.2 Male 170 44.5 30 17.8 Missing/Invalid 4 1 0 0 Age in years <30 1 0.2 14 8.3 30-39 2 0.5 28 16.5 40-49 21 5.5 49 29 50-59 90 23.6 40 23.7 60-69 129 33.8 31 18.3 >70 132 34.6 4 2.4 Missing/Invalid 7 1.8 3 1.8 Birth Country Australia 295 77.2 131 77.5 Overseas 78 20.4 37 21.9 Missing/Invalid 9 2.4 1 0.6 Education Primary 38 9.9 8 4.7 School Certificate Year 10 180 47.1 62 36.7 Higher School Certificate Year 12 70 18.3 43 25.4 Tertiary 77 20.2 50 29.6 Missing/Invalid 17 4.5 6 3.6
3.2 Objective 1: Review and Identification of Gaps in the Literature
The quality of the studies identified in the review were variable and, in many instances, poor. Trials paid little heed to concealment of allocation or masking of outcomes assessed; in very few cases a sample size calculation was reported. Most of the WMI leaflets did not adhere to what is now regarded as good practice in information design. Indeed only one trial reported any findings related to information design. It should also be noted that there are no trials that have evaluated the impact of Australian CMI on consumers’ knowledge and behaviours.
Impact on knowledge
Overall, the evidence suggests a marginally positive impact of the WMI used on knowledge, as the impact was statistically significant in about half of the trials. While knowledge might be a relevant outcome, there was a lack of clarity around its meaning in the studies. The studies tested recall of information, but none measured how recalled information translated into knowledge or informed actions. As the information items to be recalled were selected by researchers, they may not have represented the information patients themselves wanted to know. We also do not know if patient knowledge might be impacted differently if good information design had been applied.
Purpose of the information
Health professionals saw the primary purpose of WMI as providing facts that would lead to patient adherence. This contrasted with the views of patients. Patients saw the purpose of WMI as helping in decision-making (i) at the time of prescription or medicine purchase, in terms of whether or not to take it, and (ii) on an ongoing basis, with decisions about managing the medicine, interpreting symptoms and side-effects, and deciding whether medical advice was needed. Patients preferred information that related to their specific illness. However none of the effectiveness trials examined individualised information or investigated the use of information in an authentic setting that reflected the ways in which patients might use WMI.
Information patients want
Patients did not want ‘hard to understand’ information, but this was not the same as saying they wanted short and simple leaflets. Patients wanted information that related to their own condition and to know about other treatment
Findings:
• WMI may have a marginally positive effect on consumers’ knowledge. • Consumers saw WMI as a useful resource in treatment and day-to-day decision making in managing their medicines. • The length of WMI consumers needed varied, with both concise and longer leaflets valued depending on users’ needs
at a particular time in the medicine management cycle. • Positive benefit information may have an impact on perceptions of information in WMI by consumers. • Consumers did not currently value WMI leaflets; deficiencies in content and layout may contribute to this opinion. • Consumers wanted information on the likelihood of side effect occurrence. • Consumers wanted more time to discuss medicines with their doctor. • WMI content generally reflects professionals’ rather than patients’ priorities due to limited consumer involvement . • There was limited information on the ‘actual’ barriers and facilitators to CMI provision and use in community practice.
17
FINAL REPORT
options. Leaflets about medicines are rarely condition-specific, thus limiting their value to many patients. Trials of benefit information showed that it could impact on perceptions of the medicine. Consumers believed written information could not be divorced from spoken information - any conflict between them was a concern. Furthermore, WMI should not substitute for spoken information from their doctor; the latter was more highly valued.
Providing medicine information (rather than none) increased satisfaction with the information provided. The quantity of information required was not constant and both concise and longer leaflets were valued, depending on users’ needs at different times. Some of this variation in need related to the course of the disease from diagnosis to long-term experience. This emphasises the need for making available a range of different sources of information, or single sources from which the information required at a particular time can be easily identified and extracted.
Evidence confirmed that patients do not currently value the leaflets supplied. Deficiencies in content (e.g. complex language) and layout (e.g. small print size) contribute to this. The paper-based leaflet could be further improved by following the accepted principles of good information design. The findings in relation to content could also be used to guide the producers of other sources of written medicines information, including that which is web-based.
Consumers’ need for, and use of WMI varied with differing educational levels, type of pharmacy used, perceptions of pharmacists’ role, and availability and access to medicine information. They perceived pharmacists as being unable, unwilling or not knowledgeable enough as an information source. Pharmacists were often not perceived as a primary source of medicine information. Consumers often wanted WMI from the doctor at the time of prescribing.
The few studies that investigated professionals’ perspectives showed that they thought patients should receive short and simple information, believing that more complex information was not understood and would "overload" patients. Some advocated selective disclosure of side effect information, as they thought a full list could cause patients not to take a medicine. They also placed more emphasis on informing about the benefits of a medicine and what would happen if they did not take it.
Side effect information
There is a gap between patients’ and health professionals' views in relation to side effects. This is one of the highest information priorities for patients, but professionals have worries about its impact. Health professionals in the role and value studies expressed concerns about the possible negative impact of providing side effect information. But the findings suggest that some patients prefer to be ‘worried and aware’ rather than the reverse. Overall, the trial evidence showed that providing information about side effects does not deter patients from taking the medicine, or increase the side effects experienced or reported. The role of information in enabling patients to recognise side effects is potentially important and could improve medicine safety.
The only aspect of the presentation of side effects information for which robust evidence was available, covered how the likelihood of occurrence should be described. Medicine users:
- perceive the risk of a side effect to be greater when risk descriptor information is presented verbally; - have a greater intention to take the medicine when presented with numerical risk descriptor information; - estimate the severity of a side effect to be greater when presented with verbal risk descriptor information.
These trials showed clearly that numerical descriptors were superior to verbal descriptors alone.
Patient-professional interaction and adherence
Patients saw discussion with their doctor about the medicine as their primary information source. Patients in the role and value studies would have liked more time to discuss medicines with their doctor.
Adherence was included as an outcome in a small number of the effectiveness trials. Professionals saw adherence to therapy as a key purpose of the information. However, the appropriateness of adherence as an outcome measure was raised in the role and value strand of the review. That effectiveness studies found a lack of effect on adherence is not surprising, as the findings from the role and value strand confirm that medicine taking is a complex behaviour; written information is only one influencing factor.
Limited involvement of medicine users
A finding common to the role and value and effectiveness reviews was the lack of patient involvement in WMI development. The outcome measures and pre-determined response categories therefore frequently reflected professionals’ rather than patients’ priorities. The role and value review found that patients would like WMI to be written in lay knowledge. Patient testing of WMI is useful but could be more valuable if, rather than the information content of WMI being predefined by others, patients were involved in defining WMI scope and content.
Barriers and Facilitators
None of the published studies focussed specifically on determining the barriers and facilitators to the provision and use of WMI, in particular CMI, in community pharmacy practice. Most reported primarily ‘potential’ rather than
18
FINAL REPORT
‘actual’ barriers and facilitators, with limited differentiation between the two. The barriers and facilitators reported can be categorised into situational, attitudinal, cognitive, financial and informational (Table 8). The results revealed a suspected gap in the literature which was addressed in the I-CMI research project.
Table 8. Barriers and Facilitators identified in the Literature Review
Category Barrier Identified Facilitator Identified
Situational - Increased workload - Lack of Time - Lack of staff or staffing issues - Lack of storage and access to WMI leaflets - Lack of access to patients (mail-order pharmacy) - Pharmacy layout
- Automated dispensing systems to free up pharmacists time to provide cognitive services
- Increased staffing levels - Limits on prescription dispensing per pharmacist - Private counselling areas in pharmacy
Attitudinal - Community pharmacists attitudes to provision - Concern regarding increased liability for
provision of WMI - Belief patients won’t take the medicine - Belief counselling makes the job ‘more
complicated’ - Unwillingness to engage in ‘forward-pharmacy
practice’ or activities that promote the profession - Perceived limited consumer knowledge of WMI
- Promotion of the value of providing WMI to consumers (such as increased adherence, knowledge and customer loyalty)
- Promotion of WMI and education to consumers on availability of WMI
Cognitive - Limited knowledge about WMI - Limited knowledge on use of WMI in practice
- Further education and training in the use of WMI by pharmacists
Financial - Lack of financial remuneration for provision - Remuneration or financial incentive
Informational
(WMI document)
- Lack of confidence in the WMI to meet the needs of the consumer
- High readability and poor presentation of the written medicine information.
- Improvements to the WMI to be ‘user-friendly’ - Easy to understand and high quality WMI - Counselling advisory points as a checklist on the
WMI to aid the use by community pharmacists
3.3 Objective 2: Evaluation of WMI Formats from English-speaking Countries
Researcher evaluation
A total of 157 WMI for 10 prescription-only and 3 pharmacist-only medicines were collated from six English-Speaking countries. Some of the targeted examples of WMI were not found (e.g. generic brands), or not collected due to disparity with the Australian medicine scheduling. Fifty-six (36%) WMI were obtained from national repositories. Twenty-four (of 31) package inserts were electronically accessed for US, Canada, UK and Ireland. Originator brand-specific examples of WMIs comprised 58% (n=91) of WMI collected.
Findings:
• The NZ and Australian WMI performed best in adherence to format, presentation and readability criteria. • There were significant differences in WMI presentation and format across the countries. • Electronically produced WMI had higher adherence rates to format and presentation criteria but lower compliance with
the recommended reading age range. • The majority of WMI evaluated did not comply with the recommended reading age range. • Good design characteristics were identified for inclusion in the alternative CMI developed in this project. • Linguistic analysis provided potential improvements in defining the purpose of CMI, comprehension and meaning.
Gaps Identified from Literature Review:
- Generally, WMI currently available does not meet the acknowledged principles of good information design. - There is limited consumer input and involvement in the development of WMI. - There is a need for quality trials into the effect of WMI on knowledge and adherence outcomes, including long term. - There is limited information on the use of WMI in authentic settings that reflect actual consumer use. - There is limited data on how WMI content addressed the desires or needs of the medicine user. - The presentation of side effect information occurrence and risk-benefit vs positive information needs further
research to address the needs expressed by consumers. - There is limited research data on the identification and quantification of the ‘actual’ barriers and facilitators
associated with the provision and use of WMI in community practice from both HCP and consumer perspectives.
19
FINAL REPORT
The Median Test was chosen to compare compliance and readability scores (Table 9). Compliance with both sets of evaluation criteria was significantly different between countries evaluated, indicating a large international variation in WMI format and presentation. Certain format features were effectively utilised, such as minimal italics, conversational tone, and active voice. Package inserts resulted in lower compliance scores overall (61% USKCC8 & 67% TKP) compared to WMI available electronically (83% USKCC8 & 87% TKP). This might suggest that more optimal format features are present in electronically accessed WMI. However, reading grade levels were higher in electronically produced WMI (10 FKGL & 11 Fog) in comparison to package inserts (9 FKGL & 10 Fog).
Table 9. Median Compliance Scores and Median Reading Grades by Country
Leaflets Collated and Evaluated n=157 Median Compliance Rate % (interquartile range)
Median Grade Level * (interquartile range)
Country n USKCC* TKP FKGL Fog
Australia 26 81 (57-89) 90 (80-100) 9 (8-10) 10 (9-11)
New Zealand 23 83 (70-89) 90 (87-97) 9 (8-10) 11 (10-12)
US 58 55 (45-70) 63 (48-78) 11 (10-12) 12 (11-14)
Canada 20 70 (64-80) 67(53-81) 11 (9-14) 12 (11-15)
UK 18 63 (61-72) 60 (52-71) 11 (9-11) 11 (10-13)
Ireland 12 75 (57-78) 67 (59-86) 12 (9-14) 13 (11-15)
* Based on US education system; readability grades rounded to nearest whole number
NZ WMI showed consistently high adherence to both sets of criteria, followed very closely by Australian leaflets. This high adherence may be attributed to their standardised format and adherence to the Australian Usability Guidelines, and using simple terms instead of complicated medical words. The UK showed the lowest adherence to TKP. US leaflets showed the lowest adherence to USKCC8 and may highlight the fact that current US examples have poor design quality possibly due to the nonbinding regulations for WMI production in the US. The majority of the WMI samples did not comply with the recommended reading grade of 6–8. Australia had the highest proportion of leaflets demonstrating compliance with this recommended readability.
The wide variation in quality suggests the ineffective use of currently available WMI writing guidelines and the urgent need to improve both format and readability of current medicine information leaflets.
Functional linguistic evaluation
There were several main issues (described below) associated with the current Australian CMI for Lipitor® (and
consequently Mersyndol®). The detailed recommendations for each section of the CMI are found in the full report.
A lack of cohesive harmony
The opening heading ‘About this leaflet’ does not need to be topicalised and in doing so interrupts the organisation of information about the treatment. The opening section of the CMI should be revised so that the meanings about the leaflet and meanings about the medicine do not sit like two separate texts competing for the same space.
Interpersonal function or Tenor
In order for a CMI leaflet to help construe a clinical relationship as collaborative, they must represent the consumer or patient as a person with some autonomy who is capable of collaborating with a doctor or pharmacist or other medicines expert so that they can make best use of their medicine. A first step in achieving this is to make sure that the language of the CMI represents the patient as a participant in the events surrounding taking medicine and most CMIs do this. The use of statements found in the Australian Lipitor
® CMI such as ‘Your doctor has weighed
the risks of you taking LIPITOR® against the benefits he/she expects it will have for you’ conflicts with the idea of a
collaborative, concordant model of healthcare as it involves a number of construes:
• the arbiter of how risks and benefits should be weighed is the doctor, and not the patient (your doctor has weighed the risks against the benefits)
• the one who knows about benefits and risks is the doctor and not the patient (he/she expects Lipitor® to have certain
benefits and risks for you) • the patient/reader is depicted as the direct beneficiary of treatment but also the direct recipient of potential harm (risks
... benefits ... for you) • the patient/reader is depicted as somewhat active, but only in the material process of consuming the medicine (you
taking Lipitor®)
This clause may downgrade the patient’s role from potentially a collaborative decision maker to merely a medicine taker, and portrays the doctor as a unilateral decision maker.
20
FINAL REPORT
Contextual assumptions
Social linguistic theories and research suggest that people are most likely to accurately comprehend and act on important risk information when they have a familiar and clear model of the social context in which the communication about risk takes place, and a clear model of the context of any other communicative events that are discussed within that information. The patterns among Australian CMIs do not give readers a clear model of the communicative events of reading the CMI by themselves, talking through the CMI with a pharmacist, and going back to speak to their doctor when concerned, confused, or just following instructions from the CMI. Purpose of CMI in promoting risk and benefits
The key issue here was whether information about risks and benefits is balanced and unambiguous, without alarming patients unnecessarily. We note that review of the clinical content of the CMI was not within the scope of this project. Neither the current CMIs nor the revised CMIs include a section that is explicitly on the likely benefit of the medicine, although they do include a statement about indications for use and how the medicine works, as Schedule 12/13 require. Although written CMI is not intended to be used as a substitute for a frank discussion between patients and doctors about likely treatment benefits, the lack of a statement of benefit in CMIs has a number of implications. One implication is that side effects and risks may swamp the construal of benefit in CMIs. CMIs do not give indications of the likely outcome/risk of not taking the treatment, which may increase this swamping effect. A second implication is that CMIs provide consumers with indications of risk that vary in degree as the known risks of the treatment vary, so that medicines with higher risk side effect profiles are shown to have a high risk. But by contrast CMIs make all medicines sound equally effective, as they only describe what the treatment is used for and give no sense of whether it is a highly effective medicine, for the patient group, condition type etc. We believe that further research is needed on the issue of how best to position the benefits of taking the prescribed treatment, within the CMI itself and the various clinical conversations the CMI might be embedded in.
Long term suggestions
Clarifying and integrating the purposes of the text is a crucial first move for text redesign and will influence all other choices and recommendations. Instructions, explanations, information, directives, degree of patient agentivity and so on can then be arranged in the best way to suit tenor role relations that are coherent. This critical appraisal of CMI as texts would also alleviate some of the regulatory issues we found with rigid following of CMI guidelines at the expense of meaning and function. This is of course a question where the consolidated views of the research team and its external advisors and stakeholders need to be brought into interaction with the approach of linguists. The iterative collaborative process of evaluating, redesigning and testing different versions of the CMIs has helped to produce a more coherent model of text purpose and a CMI design that expresses this text purpose more clearly.
The linguistic analysis was able to provide recommendations that added to other research approaches in this project, and enhanced and complemented other approaches previously utilised. The linguistic analysis provided a number of potential improvements that had not been proposed to date about CMI documents. It also identified a number of further issues that appear to require more consideration and consultation, before recommendations about any changes in wording and/or layout can be made.
3.4 Objective 3: The Barriers and Facilitators to the Effective Use of CMI in Community Pharmacy
Findings:
• The most commonly cited barriers by consumers to CMI provision by HCPs were: limited time, HCPs beliefs that consumers do not need to know more than the verbal information provided, concerns that the information may be too difficult to read, that consumers may ask questions after reading a CMI, and that the CMI was too long to print.
• The most commonly cited barriers by HCPs were: lack of time, consumers are not interested in information, CMI is too long to print off and CMI is not available in other languages
• The most commonly cited facilitators suggested by consumers were: being aware of CMI and asking for it, making CMI provision compulsory, more time by HCPs to provide and explain CMI, and have a CMI summary version.
• The most commonly cited facilitators suggested by HCPs were: a summary CMI for counselling and more time.
Recommendations:
1. The use of current Usability Guidelines in the production of CMI should be a minimum standard of practice by all Pharmaceutical Manufacturers in order to improve format and readability of CMI.
2. Functional linguistics recommendations regarding wording and format should be incorporated into the current Usability Guidelines through a process of consultation with a Committee such as QARG.
3. Core CMI should be removed to include suggested changes to opening sections of CMI and selected standard wording.
21
FINAL REPORT
This section of the report outlines the findings in relation to the needs analysis of consumers, HCPs and key stakeholders regarding barriers and facilitators to the provision and use of CMI in community pharmacy practice.
Barriers and Facilitators
Focus Groups
A number of barriers and facilitators to CMI provision and use were reported. The biggest barrier reported by all groups was the lack of time available for consultation and provision of CMI. Many participants wanted longer consultation times to discuss information about medicines being prescribed or dispensed. Most GPs relied on the pharmacist to supply CMI, and community pharmacists felt pressured by high dispense volumes and the demand of customers to be served with minimum waiting time. This often meant that only verbal counselling was provided. Rapid patient turnover and the constantly changing medicines of patients in hospital also left hospital pharmacists little time to provide basic medication reconciliation services let alone CMI. Many consumers wanted more information but did not ask for it because of time constraints. Many pharmacists had introduced CMI integrated workflow systems and/or a ‘forward-pharmacy’ model into their practice to assist with CMI provision.
The lack of legal requirements for provision by HCPs, as well as limited awareness about and demand for CMI by consumers were seen as barriers. Almost all participants felt increasing consumer and HCP awareness through advertising and education campaigns would be of enormous benefit in increasing provision. Many consumers wanted an official website to access CMI. Several of the HCPs confirmed that they did not provide CMI to consumers, as they were concerned the patient would not take the medicine if they read the extensive list of side effect information. Most felt the length of the CMI stopped them from handing it out.
An important issue discussed by many participants was the relationship between the consumer and the GP and/or pharmacist. Many felt that establishing a rapport with a regular GP/pharmacist encouraged collaboration and information sharing. A number of consumers felt intimidated by their HCP and this was attributed to a lack of rapport, the consumer feeling less educated than the HCP, or language or literacy barriers. Consequently, consumers were often unwilling or afraid to ask for information.
Many felt that the attitude of HCPs was a barrier to CMI provision. Some respondents felt pharmacists’ attitudes to counselling and medicine information provision was not positive or conducive to distributing CMI. Consumers felt that HCPs did not want to be bothered by questions that may take up valuable time. Others felt a lack of privacy to discuss medicines was a concern, however this had been addressed by many pharmacies with semi-private or private counselling areas. This was not a reported issue with GPs.
Exclusively, CMI writers felt one of the main barriers to the optimisation of CMI was the regulatory process itself, specifically, the inclusion of information that may impact the risk-benefit decision-making process. Suggestions to administer and supply CMI by a central agency i.e. TGA were made, along with a single medicine specific CMI. Participants reported that the use of core CMIs had been helpful and produced a relatively consistent CMI in Australia however allowed little scope for individualisation of the CMI. The CMI writers indicated that pharmaceutical manufacturers are reluctant to allocate time and resources to CMI and diagnostic testing, due to lack of perceived benefit, and no guarantee of distribution by pharmacists. Diagnostic or user testing was valued, however the question of what to do with the results and decisions on CMI content were difficult.
Most respondents found the CMI document legalistic, lengthy, confusing and not patient-centred. Many suggested changes involved format (font, columns, use of graphics, headings etc). Most consumer and HCP participants felt a short, summary CMI should be available alongside the current CMI. Almost all participants in the focus groups and respondents to key stakeholder feedback wanted information on both risk and benefit, which include clearer reporting on side effects. An improved dialogue between HCPs, consumers and the sponsors of the medicine were reported as an important facilitator in determining the information content of CMI, in improving the quality of the CMI and producing patient-centred information.
Surveys with Consumers and HCPs
The top five reasons cited by between a quarter and more than half of the consumers for why HCPs do not provide CMI (Table 10) were (in decreasing order): limited time, belief that consumers do not need to know more than the verbal information provided, concerns that the information may be too difficult to read, concern that consumers may ask questions after reading a CMI, and that the CMI was too long to print.
Interestingly the top five reasons cited by community pharmacists (CPs) for not providing CMI, in general, were: 1) consumer has taken the medicine in the past, 2) consumer has difficulty understanding the CMI, 3) concern that the consumer will not take their medicine after reading the CMI (regarded as important by CPs only), 4) medicine is used for a purpose other than indicated (regarded as important by pharmacists), and 5) the medicine is for short term use. Whilst reasons 1 and 2 were shared by all HCPs, doctors ranked the fact that CMI will be provided by pharmacists second, and limited time with consumer and that the consumer receives all of their information verbally as reasons 4 and 5. Hospital pharmacists also cited limited time with consumers as an important factor.
22
FINAL REPORT
Table 10. Consumer Responses on HCPs Barriers and Facilitators to CMI Supply
Reasons for limited CMI provision (n= 999) N (%)* Facilitators of CMI provision (n = 1000) N (%)*
They have limited time or are too busy 527 52.7 For consumers to become more aware of the CMI and ask for it
404 40.4
They do not think consumers need to know more than what they tell them
346 34.6 Don't know 145 14.5
They may be concerned that the information may be difficult to understand or read
345 34.5 Legislate / make it compulsory to provide a CMI 143 14.3
They may be concerned that consumers may ask too many questions
291 29.1 Pharmacists / Doctors to devote more time to provide and explain CMI
82 8.2
The CMI is too long to print off for them 260 26.0 Nothing 44 4.4 They are not your regular Doctor/Pharmacist 224 22.4 Having a summary CMI covering important points
about the medicine 40 4.0
They are not interested in giving CMI out 177 17.7 Manufacturer to provide more information 26 2.6 They may be concerned you will not take the medicine
155 15.5 Having a regular Pharmacist or Doctor who knows the consumer well
23 2.3
I am always provided with CMI 25 2.5 Media / public education campaign 22 2.2 None/No reasons 24 2.4 If consumers paid for the CMI 17 1.7 Assume patient already knows 18 1.8 Having a self-serve computer in the Pharmacy or
Surgery to print CMI 10 1.0
Repeat prescriptions 9 0.9 If consumers could make an appointment with the Pharmacist to talk about their medicines
9 0.9
Consumers don’t ask/should ask for CMI 6 0.6 Website 7 0.7 Other reasons 42 4.2 Always given 7 0.7 Don’t know 59 5.9 If the Pharmacies have a private area for the
Pharmacist to discuss the CMI 6 0.6
* Results are not mutually exclusive, as respondents could provide several responses
Having CMI in different languages 6 0.6 Offered CMI 5 0.5 Other 91 9.1
More than three quarters of consumers reported that they do not read a CMI if they have taken the medicine in the past. This concurred with the findings of HCPs and why they do not use CMI with their consumers. This is an important and concerning finding as both consumers and HCPs may be devaluing the importance of information and CMI in consumers on chronic therapy.
When HCPs were asked about reasons why they themselves were unable to provide CMI (Figure 3), different reasons and rankings were elicited. The top four reasons cited by all HCPs were the same, however the rankings were different. It is notable that the same barriers impact HCPs provision and use of CMI, though the importance is different for each profession, and possibly individuals. It was also interesting to note that fewer CPs than HPs believed that the pharmacy workflow and layout made it difficult to provide CMI.
N=337 N=167 N=179
Figure 3. Reasons for not being able to provide CMI (Note: Results are not mutually exclusive)
Respondents identified several facilitators. The top four consumer facilitators (Table 10) were: 1) being aware of CMI and asking for it, 2) make CMI provision compulsory, 3) more time by HCPs to provide and explain CMI, 4) have a summary CMI version. HCPs also mentioned a number of facilitators to increase CMI provision (Table 11). Most of the facilitators related to how the process of CMI provision can be assisted in practice. Interestingly the most important facilitator was the availability of summary CMI containing the salient points.
A range of reasons was cited by a quarter to almost all of the HCPs as to why they gave CMI to their consumers. These ranged from having a duty of care to provide information to consumers and their carers, to reinforcing the verbal information provided, and checking that no information was missed verbally; and to involve consumers in the
58
7279
64
47 4334
51
232328
62
10
2316
916 12
7 1020
8
21
0
1319
13
0
10
20
30
40
50
60
70
80
90
100
Community Pharmacist Hospital Pharmacist General Practitioner
% Respondents
Limited time / too busy
Patients are not interested in receiving CMIThe CMI is not available in other languagesThe CMI is too long to print off
Lack of printers / printing costs
The person is not a regular customerIt is not the policy of the pharmacy
The pharmacy layout and workflow make it difficult to provideOther
23
FINAL REPORT
decision about their medicines. A few also cited (mainly CPs and GPs) that a CMI was provided because the consumer had had a bad experience in the past about their medicine.
Table 11. Facilitators cited by HCPs and their rankings
Facilitator Community Pharmacists
Hospital Pharmacists
General Practitioners
A CMI that gives a summary of the medicine 1 2 1 Increased reimbursement for provision of CMI 2 8 4 More time to provide and explain the CMI 3 1 2 A tick box on prescription form indicating that CMI to be provided by doctor 4 4 9 Dispensing software prompts CMI provision and records it automatically 5 7 3 More customer requests for CMI 6 5 7 Having a CMI in different languages 7 3 5 Counselling appointments to discuss a customer s medicines 8 6 5 Having a self serve computer in the pharmacy to print medicine information 9 9 8
Overall, the barriers and facilitators reported by HCPs and consumers may be addressed by changes in technology or process, improvements to the CMI and greater demand for and awareness of CMI. As some of these issues included limited time, issues of staffing, high workload and prioritisation, the improvements to time management such as CMI workflow strategies, automated dispensing systems, increased staffing and upper limits on scripts dispensed per pharmacist could free up pharmacists time for counselling and interacting with consumers.
Improvements to the CMI itself, through consumer consultation and testing during development, consistent application of good information design principles, adherence to accepted principles of good writing along with vigilant monitoring of CMI standards may aid in producing a patient-centred, well written document that may facilitate provision by HCPs and uptake by consumers. Additionally, addressing HCPs’ attitudes to CMI should be a priority as a greater understanding of its impact on health and knowledge outcomes for consumers may encourage HCPs to utilise CMI and incorporate it into their routine practice. Lastly, regulators and industry bodies may need to address the underlying barriers of HCPs towards CMI.
3.5 Objective 4: Development of Alternative CMI Formats
Overall, general changes were made which applied to all CMI documents:
• The use of ‘plain English’, removal of jargon or technical terms was incorporated into the document in order to provide clear and concise information. The theory behind ‘plain English’ writing is that the ‘intended audience can read, understand and act upon the first time they read it’.
• The use of bold was minimised in the revised text and was used for tier 3 and 4 headings, and for what was considered ‘more’ important information where emphasis of a point was deemed to be suitable. The original
Findings:
• Seventeen new alternative CMI were produced using different fonts, layouts and design features. • The use of plain English, design principles and re-organisation of information reduced word count and CMI length. • Changes to tiering for headings and sub-headings improved text search. • Specific attention to the structure of sentences and paragraphs spacing improved visual organisation and readability
Recommendations:
1. Consumer consultation on the scope and content should become standard practice during CMI development and testing.
2. Consideration should be given to evaluating time management strategies for pharmacists such as changed practices, caps on dispensing limits for pharmacists, automated systems and increased staffing levels.
3. A HCP education package should be implemented to increase CMI awareness and foster CMI use with consumers. The education package should include on-going assistance and strategies to incorporate CMI into daily practice.
4. Consumer awareness should be increased through: o Focused high intensity and ongoing media campaigns promoting awareness of CMI availability. o A single prominent and user-friendly Internet based repository for consumers. The address for this should also be
listed on each CMI. o Verbal promotion by HCPs during consultations.
5. Strong consideration should be given to the development of a summary CMI to be available to consumers through the medicine box, Internet and prescribing and dispensing software. This should be in addition to the existing CMI.
6. The desire by both HCPs and consumers for information to be available on positive benefit information and for clearer side effect reporting should be evaluated and researched further.
7. Investigations should be made into how dispensing and prescribing software may be streamlined to automatically prompt and record CMI provision.
24
FINAL REPORT
CMI format included both bold headings and a significant number of bolded sentences in the main text. This had the effect of reducing the impact of bolded information. Hence bolding was reserved for headings and only the most important pieces of main text. The decision on important information was sourced based on clinical content and safety implications using a number of sources.
• New sub-headings were included, for the organisation of ‘like’ information. An example of the new sub-headings included: Pregnancy and Breastfeeding; Food and Drink; Driving and Using Machines. These sub-headings incorporated related information in order to increase localisation times and comprehension. The re-organisation of this information also allowed people to ‘self-tailor’ the information, skipping over sections that did not apply to them i.e. Pregnancy and Breastfeeding if they were male.
• The re-organisation of information reduced repetition, overall word count and length of the CMI document. • Changes were made to font (Frutiger, Roman bold and Semi-bold) and layout (portrait and landscape). • Brand name in upper case (capitals) were made lower case, as capitals placed an overemphasis on the brand
name of the medicine. Words in capitals are harder to read than those in lower case, because the shape of words helps the brain to quickly recognise words. Words in capitals have less 'shape' and hence are less quickly recognised. This problem is magnified in CMI such as this, where the name of the product is repeated.
• As headings assist readers to text search, they need to be visually distinct or different. Therefore clear headings and sub-headings were introduced, where necessary, using bold and differing font sizes depending on their tier.
• Tier 2 headings were reverse tiered with black background and white writing e.g. How to take Lipitor
• Tier 3 headings were in bold and were 1 point font size above that of the text. • Tier 4 headings were in bold but remained the same size font as that of the body of the text.
• Particular attention was given to the structure of sentences and paragraphs and how they ‘hung’ together under a heading or bullet point to improve visual organization and readability. A good example of this is shown in the box below. In this example of the original CMI text, the reader may be uncertain as to which bullet point the sentence ‘This medicine may increase…stroke’ belongs to. In other words, is it a header for drinking alcohol or does it belong to the sentence above? The revision has clarified this.
Original CMI Text Revised text: Tell your doctor if you:
• have any other medical conditions including:
• liver problems
• muscle pain, tenderness or weakness from other medicines used to treat cholesterol or triglycerides.
• have had a type of stroke called a haemorrhagic stroke or a type of stroke called a lacunar stroke
This medicine may increase the risk of you having another haemorrhagic stroke
• drink alcohol regularly
Check with your doctor before you start taking Lipitor if:
• you have liver problems • you have had muscle pain, tenderness or weakness from
other medicines used to lower cholesterol or triglycerides • you have had either a ‘haemorrhagic stroke’ or a ‘lacunar
stroke’. This is because Lipitor may increase the risk of you having another stroke
• you drink alcohol regularly
The original CMI plus seventeen (17) new alternative formats were produced including one CMI based on recommendations from the RED3 Report
27. This latter format was included because Lipitor
® had been previously
user tested by RED3, and recommendations were made for its improvement. This CMI was considered a useful comparison for the user testing results of the remaining 16 alternative CMI formats developed as part of the I-CMI project. Ten of the 18 new CMI were chosen for User Testing. These 10 CMI encompassed all changes in design, format and language made by the research team in developing the alternative CMI.
Recommendations:
1. Consumer consultation on the scope and content should be an integral part of all stages of CMI development, and prior to undertaking of any formal testing process.
2. The development of CMI should be an individually reviewed process with particular attention given to structure, bullet points and use of bold to improve readability.
3. Clear headings (such as reverse tiering) and sub-headings should be incorporated in CMI. 4. Specific sub-headings relating to pregnancy, food and driving, should be included when writing CMI in order to improve
localisation and comprehension.
25
FINAL REPORT
3.6 Objective 5: Evaluation of Alternative CMI Formats with Consumers
The new alternative CMI formats were tested for ease of use and understanding, and consumers’ ability to act on content information, in comparison to the current CMI in use in Australia. The outcome of the testing informed the final alternative CMI formats selected for the CMI Trial in community pharmacies.
User Testing Results
Appendix 16 and 17 provide a summary of the overall testing results for each CMI format, demonstrating that all except one CMI met the scoring criteria as set out in Sless
21 and the EU protocols. The CMI that performed the
most poorly was the current Australian Lipitor® CMI. The alternative CMI formats developed showed significant
improvements on the current Lipitor® and Mersyndol
® CMI. The considerable difference in results between the
current Lipitor® and Mersyndol
® CMI, and the respective re-written CMI (with no design format changes) showed
the significant impact that simple re-organisation of information, and improved written communications techniques such as use of plain language, can have. There were no situations where the participants were able to find the information but unable to understand it. Comprehension of the information in all of the leaflets was relatively unproblematic where answers were found.
Appendix 18 and 19 provide question response times and CMI reading times. The overall average time to answer questions varied significantly between the original CMI (1.23 min) and the new formats (13–46 sec). Average reading times varied and times remained within the 8 to 11 minute range for the full CMI and 4 to 6 minutes for the summary versions. Average times to answer the questions can be valuable in determining how quickly participants are able to locate the required information. This information should not be considered in isolation, as the CMIs tested (except the summary versions) were long, and some participants are likely to take longer to find information than others. Reading times can provide a measure of how long it may actually take a person to read the CMI. However, this has limitations as although participants are asked to read the CMI prior to testing, it was not possible to determine whether participants skimmed through or thoroughly read it. Peoples reading ability also varies.
The incorporation of user testing in the overall development of the alternative CMI formats was an invaluable and crucial step towards producing documents that were easier to navigate, read and understand. Positive results were seen solely through CMI reformatting by an information design expert, and rewriting using a functional linguist, researchers with clinical knowledge, and good written communication principles. The positive results and improved CMI formats demonstrate the need for broader incorporation of user testing into the production cycle of CMI.
Selection of CMI for the CMI Trial
The five alternative CMI formats (Appendix 7-11) selected for the CMI Trial were three Lipitor® (two comprehensive
and one summary) and two Mersyndol® (one comprehensive and one summary) CMI (Table 12). In selecting the
final CMI, it was important to include CMI with the desirable characteristics reported from the Needs Analysis, and ensure that the selected CMI had performed well (and better than the current CMI) in the user testing. The rationale for the CMI selected has been reported in Table 13. Although the value and impact of user testing for a document’s document is invaluable, reliance on purely those results was not the only consideration given to final CMI selection given the project’s brief. User testing is an effective process in identifying areas of the CMI that require change, and may increase the consumer’s ability to find and interpret information. However it is not a process that can be generalised to the entire population. Thus, it was imperative to incorporate the findings of the Needs Analysis.
Table 12. CMI selected for Trial in Community Pharmacies (Step 5)
CMI Version number
CMI Trial Version Name
Content
Med Col-umn
Box Use
Cont-act Info
ADR Table
Page layout
Font Font Size (pt)
Page Nos
I-CMI 1 LIP-POR (Full) Lip 2 Y Y Y (Split) Portrait R-B 10 4
I-CMI 2 MER-POR (Full) Mer 2 N Y Y Portrait R-B 10 4
I-CMI 4 LIP-LAN (Full) Lip 4 N Y N L/Scape R-B 10 3
I-CMI 5 LIP-SUM (Summary) Mer 6 N N N L/Scape Frutig 8 1
I-CMI 7 MER-SUM (Summary) Lip 3 Y Y N Portrait Frutig 9 2
Findings:
• All new alternative formats displayed superior performance to the current CMI. • Changes to wording and re-organisation of information alone (without design and layout changes) showed significant
improvement in the User Testing. • Time to find information within the alternative CMI was significantly improved, although there were no significant
changes in overall reading time of the different CMI. • User testing was a valuable tool in identifying areas for improvement in layout, comprehensibility and language. • Five alternative CMI formats with specific desirable properties and improved performance were selected for the Trial.
26
FINAL REPORT
Core CMI
Appendix 20 provides a broad overview of the research findings regarding preferences, performance and usability of two current CMI that have been amended with several variants as detailed above. These have been examined in a preliminary manner and the outcomes suggest that the current Usability Guidelines may need to be reviewed alongside the current regulatory framework. Appendix 21 highlights areas of the new CMI format that could be used as ‘standard wording’ for the Core CMI. Whilst Core CMIs assist in providing consistent and regulated documents, this may be at the expense of meaning, function and cohesive harmony. Thus, Core CMI clauses should be used critically and within the context of the whole document itself.
A review of the research findings and standard wordings (pages 35-37; and Appendix 20 and 21) should be conducted systematically in consultation with existing key stakeholder groups such as consumers, healthcare professionals, pharmaceutical industry, QARG, EDWG and Healthlinks in order to redraft the current Usability Guidelines or develop alternative frameworks if required. Broad and systematic consultation would also provide a forum for input into compliance with the current Usability Guidelines, or other proposed policies that may guide CMI production in the future.
Table 13. Rationale for CMI Selection for the CMI Trial
CMI Specific Characteristics the CMI were selected for Comments on Choice
I-CMI 1
(Lipitor®
)
- 2 column portrait format - important contact information in a box on the front page
above text columns - index of headings - side effects information in a table with action to be taken - sections numbered to correspond with the index - section numbers: black on white background - section headings: white on black background
This performed not as well as two other similar new formats, but better than the original CMI, in user testing. The difficulties associated with this format, related to two specific areas – location of the contact information box and the side effect table.
I-CMI 2
(Mersyndol®
)
- 2 column portrait format - important contact information on the front page (not in a
box), after the index - index of headings - side effects information in a table with action to be taken
(different to I-CMI 1) - sections numbered - section headings: white on black background
This performed similar to re-write CMI (format 18) and has almost identical characteristic to I-CMI 1 with contact information in text column and not boxed, but did not show the same difficulties. The reasons may be that the contact information was incorporated into the normal flow of text and was possibly considered in the document’s context. The side effect table did not pose any problems in the testing, possibly as it was simpler and had less gridlines.
I-CMI 4
(Lipitor®
)
- landscape (and therefore four columns), - important contact information on the front page (in a box)
before the index (a point of difference with I-CMI 1) - index of headings - sections numbered to correspond with the index - sections numbers: black on white background - section headings: white on black background
The performance of Lipitor I-CMI 4 (format 7) was marginally worse in the average question time, reading time and ‘difficulty’ experienced in finding information, during the user testing compared to I-CMI 3 (format 5) and format 18.
I-CMI 5
(Mersyndol®
Summary)
- landscape (and therefore six columns) - one page, single sided - section headings: white on black background
This was chosen as a summary of the information in a re-written CMI. Selected on the basis of reported consumer and HCP desire to have a shorter or summarised CMI.
I-CMI 7
(Lipitor®
Summary)
- portrait - three columns, two pages (single if double sided), - all the main information is on first page - no index as it was unnecessary - no numbering of the sections
This was selected as it was a rewritten summary CMI whose content still fell within the TGA requirements of Schedule 12. This CMI was selected over another summary format because it performed better in the user testing.
Recommendations:
1. The conduct of user testing by pharmaceutical companies should be strongly encouraged for all CMI and should involve consumer consultation both during development and the formal testing process.
2. Further modification, evaluation and testing should be completed on the best performing CMI from the CMI Trial in order to refine and optimise readability, comprehensibility and design. Outcomes of this testing should consolidate the findings of this study and if necessary inform changes in the Usability Guidelines.
3. The current Core CMI should be reviewed and key aspects of the new alternative formats adopted into the Core CMI. A committee to review this could be set up under existing groups such as QARG. Funding for this group would be essential in order to employ a dedicated team to thoroughly evaluate the new Core CMI.
27
FINAL REPORT
3.6.1 Overview of Research Findings for CMI
1. Design and Formatting Findings
LAYOUT Headings As headings assist readers to search text, they need to be visually distinct or different. Therefore clear headings and sub-headings should be introduced, where necessary, using bold and differing font sizes depending on their tier.
• Tier 2 headings to be reverse tiered with black background and white writing e.g. How to take Lipitor
• Tier 3 headings to be in bold and 1 point font size above that of the text • Tier 4 headings to be in bold but remain the same size font as that of the
body of the text New Sub-headings New sub-headings should be included, for the organisation of ‘like’ information.
The new sub-headings may include: Pregnancy and Breastfeeding; Food and Drink; Driving and Using Machines or others as necessary based on the individual CMI. These sub-headings would incorporate related information in order to increase localization times and comprehension. This may allow users to locate information more rapidly. The re-organisation of information also allows people to ‘self-tailor’ the information, skipping over sections that do not apply to them i.e. Pregnancy and Breastfeeding if they were male.
Bullet Points The use of bullet points to organise lists of information assist with better processing of information by the user.
Columns Two column format was most preferred in testing.
Emphasis The use of bold should be minimised in the text and used for tier 3 and 4 headings, and for what is considered ‘more’ important information where emphasis of a point is deemed to be suitable. Overuse of both bold headings and a significant number of bolded sentences in the main text has the effect of reducing the impact and text recall of bolded information. Bolding should be reserved for headings and only the most important pieces of main text. The decision of what is deemed important information should be based on both clinical content and the safety implications using a number of evidence-based clinical resources eg MIMS on line, the medicines’ Product Information, AMH.
Pictures and Graphics Consumers and HCPs expressed a preference for the use of pictures and graphics. The use of these was not introduced in the course of the project due to the print capacity limitations within pharmacies. However the logos of both Pfizer and Sanofi Aventis were used on the CMI as well as a standardised logo. Test participants felt this made the document look more ‘official’.
Navigation Aids Where to find information in this leaflet
1. What ‘Medicine’ is used for 2. Before you take ‘Medicine’ 3. How to take ‘Medicine’ 4. While you are taking ‘Medicine’ 5. Side effects 6. Product details
Table of contents provides an anchoring point for the first section. The numbering corresponds to the relevant section of the leaflet, and should be incorporated to aid in users finding information topics of interest quickly. The colour of the numbers was the same in the list as well as the sections in the CMI.
LENGTH Line Length Short lines are preferred however the 3 column style sentence may be considered too short and ‘newspaper-like’.
Line Spacing Particular attention should be given to the structure of sentences and paragraphs and how they ‘hang’ together under a heading or bullet point to improve visual organization and readability. Orphan sentences that cross over to the next page reduce readability and localisation of information.
Document Length The document length should be kept to a minimum where possible.
TYPE Font Sans Serif was most preferred e.g. Frutiger or Myriad Roman Bold or Semi-Bold.
28
FINAL REPORT
Font Size Minimum 10 point font size.
Colour The use of colour was suggested by many participants however print limitations within pharmacies did not allow for exploration within this project.
2. Wording and Linguistic Changes – See also CORE CMI Example and Specific Linguistic Recommendations by Alison Moore
GENERAL LANGUAGE
Word Choice The use of ‘plain English’, The theory behind ‘plain English’ writing is that the ‘intended audience can read, understand and act upon the first time they read it’. Incorporating this with good document design principles and layout, should produce medicine information that people can rely on when they make decisions or need to act upon an adverse event when using their medicine.
Repetition Repetition throughout the document was removed through the re-organisation of information with the addition of sub-headings.
Jargon The removal of jargon or technical terms where possible is necessary in order to provide clear and concise information.
Phrasing ‘Lipitor’ replaced ‘LIPITOR’ in capitals, as capitals placed an overemphasis on the brand name of the medicine. It also goes against good writing principles as recommended previously by Sless
32. Words in capitals are harder to read than
those in lower case, because the shape of words helps the brain to quickly recognise words. Words in capitals have less 'shape' and hence are less quickly recognised. This problem is magnified in CMI such as this, where the name of the product is repeated frequently.
Important Contact Information
The inclusion of important contact information and website address for more information was based on focus groups and the desire by consumers and health care professionals to be directed to a legitimate site that contained the CMI. The location of this information should be located within the text prior to the table of contents.
3. Consumer review and input Consumers and Representative Groups
Consultation prior to and during CMI development should involve consumer input through either individuals with firsthand experience of the disease state being treated, an expert in the area or with representatives from a disease specific consumer group. A formal process could be introduced seeking specific feedback on needs and opinions.
4. User Testing
Inclusion Criteria In order to ensure that participants are representative of the general population of likely users of the medicine being tested each round of ten should consist of a sampling of:
• Age: minimum of one person in each decade between 30 and 70-plus (Lipitor
®) and 20 and 70-plus (Mersyndol
®)
• Gender: minimum 3 participants of each gender • Education: no more than 3 higher education graduates (ABS statistics
59)
• Literature use: at least 2 participants who either do not use written documents as part of their work, or who are currently not working or retired
• Non-English speaking: where possible a one participant whose first language is not English
It would be ideal if a basic health literacy questionnaire could be completed prior to User Testing to determine the impact of overall health literacy on testing results.
Important Contact Information for your Medicine: • Emergency: 000 • Australian Poisons Information Centre: 13 11 26 • NPS Medicines Line: 1300 888 763 • Pharmaceutical Company: 1800 000 000 • Website: www.medicines.org.au
29
FINAL REPORT
User testing Questions The first stage in the development of the user testing questionnaires (UTQ) involves determining the key information that is important for the safe and effective use of the medicine by consumers, and which related specifically to safety, urgent actions or referral, dose, use, precautions, interactions or contraindications for the medicine. This involves reference to various clinical medicine information sources such as Micromedex, the Australian Medicines Handbook and the medicine’s Product Information. Ideally a registered pharmacists should review the key points identified.
The questions in the UTQ should focus on these key points or messages. The purpose of the questions is to mimic real life situations and reflect possible questions or concerns that an actual user may have. The questions themselves should focus on three main areas:
• Facts e.g. Dose; what the medicine is for? • Actions required e.g. what action would you take if you missed a dose? • Explanations of action or outcome e.g. Why can’t you drive while taking this
medicine? The questions should be chosen from information in each of the main sections, to give appropriate coverage. The fifteen questions produced should be reviewed by at least one other appropriate person and then pilot tested on two participants.
User Testing Two rounds of 10 subjects to be tested and CMI scored as per the criteria in the Usability Guidelines. Results should be fed back in an iterative and formative process to determine the strengths and weaknesses of the document itself. This process will determine whether and where the document requires rewriting or reformatting. An internal quality control mechanism should ensure consistency and veracity of testing.
5. Review by independent committee
Independent committee including all key stakeholders (eg consumers, healthcare professionals, QARG, pharmaceutical manufacturers,)
A set of standard protocols (incorporating Usability Guidelines and changes to the Guidelines as a result of the project’s findings) should be developed to inform a minimum standard of CMI produced by Pharmaceutical Manufacturers. An independent body should oversee and maintain these quality standards.
3.7 Objective 6: Evaluation of Alternative CMI Formats in a Community Pharmacy Setting
The majority of consumers recruited into the study were regular users (86%-98%) of Lipitor® or Mersyndol
® and
received their medicine from their pharmacist or pharmacy graduate. Interestingly, more pharmacists were involved in the provision of the medicine with new Lipitor
® and Mersyndol
® CMI when compared to the current CMI version.
This may highlight the fact that the pharmacists were handing out new types of written information to their patients and wanted to interact more with them.
The proportion of consumers who were counselled varied depending on the type of CMI provided (Table 14). With the exception of LIP-POR, a staff member spoke to most of the consumers about their medicine. It is reassuring to see that the majority of consumers on Mersyndol
® were counselled. However, when asked who counselled the
consumers about their medicine, in the case of Lipitor®, the majority were counselled by the pharmacist, whilst with
Mersyndol®, the pharmacy assistant and graduate also played a significant role. Interestingly, more pharmacists
counselled consumers with the alternative CMI that looked the most different from the current available CMI for both Lipitor
® and Mersyndol
®. This may highlight the fact that pharmacists want to ensure that their consumers are
adequately aware of what the new written medicine information document is that they are providing them.
Findings:
• Pharmacists were more likely to provide the new format CMI than the existing CMI. • Both consumers and pharmacists felt the information in the CMI was informative and that the new formats were
considered less long than the current CMI. • A statistically significant proportion of consumers indicated they had kept the summary CMI formats. • The new alterative formats were more likely to be read, used and kept than the existing CMI. • Predominantly new format CMI were ranked higher in usefulness and quantity of information. • Consumers reported no significant difference in preference in format and design between existing and new CMI.
30
FINAL REPORT
The pharmacists reported that in most cases of the original Lipitor® and Mersyndol
® CMI, they encouraged the
consumers to read the CMI (Table 14). However, more pharmacists / pharmacy staff briefly reviewed the new CMI for Lipitor
® (LIP-POR & LIP-SUM) and Mersyndol
®. When asked about the CMI and how the information was
received the majority of consumers responded that they were encouraged to read the CMI (this was similar to the responses provided by the pharmacists). However, about a third of consumers (in 5 out of 7 CMI formats) also had the CMI briefly reviewed with them. There was a statistically significant difference between the MER-AUS and MER-POR, in that a larger proportion of consumers were encouraged to read the CMI, and fewer had the CMI reviewed with them than the original CMI.
Overall, the majority of pharmacists and consumers felt that the information that was provided was informative (Table 14). The majority of pharmacists felt that the Lipitor
® CMIs were informative, and more felt that the new
forms were informative compared to the currently available Lipitor® format. In the case of Mersyndol
®, a large
majority of pharmacists felt that the one page new CMI was informative. It is possible that pharmacists believed that less information should be available and provided to consumers collecting over the counter medicines than prescription only medicines. Overall, fewer pharmacists believed that the new alternative formats (all five) were too long when compared to those who believed that the currently available CMI were too long. No one thought any of the CMI were short. However, the consumers in each arm of the study were not exposed to all alternative CMI and may have been exposed to the original CMI in the past. Therefore, they could not base their judgement on a comparison between all new CMI. Overall, the new CMI formats were given better ratings by the pharmacists.
Table 14. Pharmacist and Consumers Experiences with CMI
Outcome Variables LIP-AUS LIP-POR
I-CMI 1
LIP-LAN
I-CMI 4
LIP-SUM
I-CMI 5
MER-AUS MER-POR
I-CMI 2
MER-SUM
I-CMI 7
Ph= Pharmacist, Con = Consumer, (% of participants)
Ph %
Con %
Ph %
Con %
Ph %
Con %
Ph %
Con %
Ph %
Con %
Ph %
Con %
Ph %
Con %
Proportion Verbally Counselled
Yes 67 40 55 39 91 51 72 19 90 70 93 31 95 73
No 33 60 45 61 9 49 28 81 10 30 7 69 5 27
Person Counselling Pharmacist 70 85 90 89 83 78 74 80 56 71 33 73 37 70 Pharmacy graduate/intern 29 0 7 5 17 0 21 0 16 4 13 0 7 3 Pharmacy assistant 1 7 2 5 0 19 5 20 42 21 54 18 10 23 Don't know 1 7 0 1 0 3 0 0 0 4 0 9 0 3 How Information Provided Simply handed out 15 0 18 10 3 8 4 4 10 15 11 3 9 5 Consumer was encouraged to read it 72 72 43 71 84 63 50 69 86 50 85 83 68 66 Pharmacist/Staff briefly reviewed it 43 28 43 16 56 28 50 23 28 30 33 14 55 29 Pharmacist/Staff spoke about it in detail 5 0 5 2 9 1 0 4 8 5 7 0 0 0 Amount of written information
Too long 28 6 9 8 19 6 0 8 20 10 31 11 4 7
Too Short 0 0 0 0 1 0 0 0 0 0 0 0 4 0
Too much 22 2 19 8 16 6 0 0 37 3 38 0 9 5
Informative 60 86 72 73 73 83 100 88 43 80 38 83 84 73
Not informative 4 1 0 0 0 0 0 0 2 0 0 0 0 0
Other 0 5 0 10 0 6 0 4 0 8 0 6 0 15
The majority of consumers retained and read the CMI they had received. Interestingly, a statistically significantly larger proportion of consumers kept the summary Lipitor
® (LIP-SUM) and Mersyndol
® CMI (MER-SUM), as well as
the Lipitor® (LIP-POR). This may indicate the value they placed on the CMI.
Consumers were asked about their overall impressions of how easy / hard it was to read and understand information in the CMI documents they were provided (Table 15). Overall, the new Mersyndol
® formats were easier
to read than the existing ones. Furthermore, the Lipitor® LIP-POR was the easiest format compared to the other
three types. Similar patterns were also observed in consumers’ perceptions of how easy it was to understand the information (Table 15). The differences observed in the Lipitor
® CMI (LIP-POR compared to LIP-LAN and original
CMI LIP-AUS) were statistically significant.
Consumers were also asked about how likely they would be to read, use and keep the information, if they had just been prescribed their medicine and received the CMI from their pharmacist (Table 15). It appears that a statistically larger number of consumers would be likely to read the alternative CMI format LIP-POR for Lipitor
® compared to
the other formats. However, similar responses were provided for the three Mersyndol® CMI formats.
31
FINAL REPORT
A statistically significantly larger proportion of consumers commented that they were unlikely to use the LIP-AUS and LIP-SUM versions of Lipitor
® (Table 15), which would be expected if they were also unlikely to read the
information. It was interesting to note that consumers felt they were unlikely to use the summary LIP-SUM considering it was what many consumers stated they wanted. A statistically significantly larger proportion of consumers reporting that they would be less likely to keep the original Lipitor
® CMI (LIP-AUS) if they had received
the information when they were first prescribed their Lipitor®.
Table 15. Consumer Perceptions of Alternative Format CMI
Factors affecting CMI LIP-AUS LIP-POR
I-CMI 1
LIP-LAN
I-CMI 4
LIP-SUM
I-CMI 5
MER-AUS MER-POR
I-CMI 2
MER-SUM
I-CMI 1
% of Participants % % % % % % %
Ease of Reading
Very easy 51 73 55 53 57 72 64
Quite easy 47 27 45 47 38 28 36
In between 1 0 0 0 5 0 0
Quite hard 0 0 0 0 0 0 0
Very hard 0 0 0 0 0 0 0 Ease of Understanding the information
Very easy 43 73 49 53 38 67 61
Quite easy 53 24 45 47 52 33 39
In between 4 3 2 0 10 0 0
Quite hard 0 0 4 0 0 0 0
Very hard 0 0 0 0 0 0 0
How likely to read the information
Very likely 47 76 47 27 67 56 75
Somewhat likely 26 18 35 47 24 33 11
Unsure 3 0 4 0 0 0 0
Somewhat unlikely 24 6 12 27 5 11 14
Very unlikely 0 0 2 0 5 0 0
How likely to use the information
Very likely 40 70 43 27 38 39 71
Somewhat likely 32 21 37 47 38 50 14
Unsure 4 3 4 0 14 0 0
Somewhat unlikely 24 6 14 27 5 11 14
Very unlikely 0 0 2 0 5 0 0
How likely to keep the information
Very likely 32 64 43 27 48 28 46
Somewhat likely 59 33 47 60 38 56 32
Unsure 9 3 10 13 14 17 21
Somewhat unlikely 0 0 0 0 0 0 0
Very unlikely 0 0 0 0 0 0 0
Consumers were questioned on how much information they had received in the CMI with respect to the information content of a CMI, and how useful this information was. It appeared that overall, CMI LIP-SUM of the Lipitor
® and
MER-POR of Mersyndol® performed the best with regard to containing ‘about the right amount’ of information. LIP-
SUM is a summary version, while MER-POR is the full version. It is possible that the Mersyndol® consumers have
not previously received any CMI with their Mersyndol®, and therefore they prefer this comprehensive version over
one that contains summarised information.
On the perception of the usefulness of the information, interestingly, while the two LIP-SUM and MER-POR had superior performance in quantity of information, they did not perform the best with regard to the usefulness of the information. This is in an interesting anomaly, and may be due to the overall impression of the usefulness of the document, taking into account the design and format as well as the content of the CMI. LIP-POR and MER-SUM were perceived as the most useful, which is the opposite to what performed best in regards to quantity of information. Appendix 22 gives a full list of the rankings for each CMI format.
Consumers were also asked to comment on the CMI format and design. Overall, the majority to almost all of the consumers felt that the CMI formats, including the current Australian CMI formats, were well organised, attractive, contained appropriate print size, were not alarming in tone, were helpful, unbiased and had good line space
between the words. No significant differences could be seen in the consumers’ perceptions of the format and design between the different formats. Overall, evidence from this trisummary CMI were the most preferred
3.8 Objective 7: The Optimum Delivery FMedicines
A workflow and CMI change management plan was developed to CMI provision and use in order to optimevaluate the workflow change management plan during the CMI Trial. included at least four stages (Figure 4). people and organisations involved. These el
An analysis of the barriers and facilitators in the provision of pliterature review and Needs Analysis, was used in identifying the areas requiring change. This analysis identified aspects that require change from different people involved in the process of CMI development, provision and evaluation. There are also different stages in the cycle of change and service implementation that these barriers and facilitators need to be actioned. The following points outline when and how these elements can be addressed.
Readiness for Change
Readiness for change refers to:
- Improving the CMI document to facilitate its use: redesigning, improving readability, audit of clinical content and availability of CMI.
- Changing the attitude of pharmacists and other stakeholders to CMI: utilisation of professional associations and educators e.g. PSA and the Pharmacy Guild to promote awareness and use
- Building the capacity of pharmacies to integrate CMI: determining service levels and capacity to implement CMI services.
Preparation for Change
Preparation for change begins with establiplan to overcome these barriers. Appendix owners/managers should be addressing to overcome them. Once the barriers tobeen overcome, the facilitators should be addressed to best support the change (Appendix
Implementation
The implementation stage of CMI provision requires a change to the workflow of the pharmacy that goes beyond the typical dispensing process. Appendix the dispensing process. Full details of each stage can be found in the full report.
Findings:
• Change in the practice of community pharmacy involves four stages: readiness for change, preparation for change, implementation and evaluation.
• A systematic plan and ongoing evaluation and support are necessary to implement changes to workflow in order to improve CMI provision and use in community pharmacy.
Recommendations:
1. A review of the current layout and design of CMI, contact information, side effects tables, should be conducted.
2. The provision of a summary CMI option may be a viable option especially for OTC medicines.
FINAL REPORT
between the words. No significant differences could be seen in the consumers’ perceptions of the format and Overall, evidence from this trial suggests that the two formats.
he Optimum Delivery Format of CMI for S2 and S3
A workflow and CMI change management plan was developed to address the barriers and support the facilito CMI provision and use in order to optimise delivery in community pharmacy practice. evaluate the workflow change management plan during the CMI Trial. The overall change management plan
. Each stage needs to be supported to varying degrees by the distinct people and organisations involved. These elements are outlined further below.
Figure 4. Change Management Cycle
An analysis of the barriers and facilitators in the provision of pharmacy services, specifically Wliterature review and Needs Analysis, was used in identifying the areas requiring change. This analysis identified aspects that require change from different people involved in the process of CMI development, provision and
also different stages in the cycle of change and service implementation that these barriers and facilitators need to be actioned. The following points outline when and how these elements can be addressed.
Improving the CMI document to facilitate its use: redesigning, improving readability, audit of clinical content
Changing the attitude of pharmacists and other stakeholders to CMI: utilisation of professional associations cators e.g. PSA and the Pharmacy Guild to promote awareness and use
Building the capacity of pharmacies to integrate CMI: determining service levels and capacity to implement
begins with establishing the relevant barriers to individual pharmacies and developing a plan to overcome these barriers. Appendix 23 outlines the identified barriers and the relevant issues pharmacy
/managers should be addressing to overcome them. Once the barriers to the specific service provision have been overcome, the facilitators should be addressed to best support the change (Appendix
The implementation stage of CMI provision requires a change to the workflow of the pharmacy that goes beyond he typical dispensing process. Appendix 25 outlines a workflow strategy that integrates the provision of CMI with the dispensing process. Full details of each stage can be found in the full report.
Readiness for Change
Preparation for Change
Implementation
Evaluation
Change in the practice of community pharmacy involves four stages: readiness for change, preparation for change,
A systematic plan and ongoing evaluation and support are necessary to implement changes to workflow in order to improve CMI provision and use in community pharmacy.
the current layout and design of CMI, with specific consideration to the inclusion of ide effects tables, should be conducted.
The provision of a summary CMI option may be a viable option especially for OTC medicines.
32
FINAL REPORT
between the words. No significant differences could be seen in the consumers’ perceptions of the format and al suggests that the two-column portrait and
S2 and S3
barriers and support the facilitators . It was not possible to
overall change management plan Each stage needs to be supported to varying degrees by the distinct
harmacy services, specifically WMI and CMI from the literature review and Needs Analysis, was used in identifying the areas requiring change. This analysis identified aspects that require change from different people involved in the process of CMI development, provision and
also different stages in the cycle of change and service implementation that these barriers and facilitators need to be actioned. The following points outline when and how these elements can be addressed.
Improving the CMI document to facilitate its use: redesigning, improving readability, audit of clinical content
Changing the attitude of pharmacists and other stakeholders to CMI: utilisation of professional associations cators e.g. PSA and the Pharmacy Guild to promote awareness and use.
Building the capacity of pharmacies to integrate CMI: determining service levels and capacity to implement
shing the relevant barriers to individual pharmacies and developing a outlines the identified barriers and the relevant issues pharmacy
the specific service provision have been overcome, the facilitators should be addressed to best support the change (Appendix 24).
The implementation stage of CMI provision requires a change to the workflow of the pharmacy that goes beyond outlines a workflow strategy that integrates the provision of CMI with
Change in the practice of community pharmacy involves four stages: readiness for change, preparation for change,
A systematic plan and ongoing evaluation and support are necessary to implement changes to workflow in order to
the inclusion of features such as: boxed
The provision of a summary CMI option may be a viable option especially for OTC medicines.
33
FINAL REPORT
Evaluation
The final step in the change cycle, evaluation, focuses on feeding back performance at two levels – individual pharmacy (e.g. waiting ticket scenario) and the profession overall (e.g. on-site evaluation). This means the quality of the service delivery is monitored and a pre-determined level of service provision can be maintained. The evaluation stage then returns to the first part of the cycle, readiness, where the pharmacy and profession’s capacity is reassessed depending on the outcomes of the evaluation stage.
3.9 Additional Key Findings
The project itself explored a number of themes associated with the provision and use of CMI. Below are some additional key findings that related to the Needs Analysis- Quantitative Stage (telephone and mail surveys).
Awareness and knowledge of CMI
Consumer awareness of CMI was similar in this study compared to a study conducted in April 20041. However,
about a quarter of the study sample were aware of CMI, but were not familiar with the term. By including this latter group, our study demonstrated that about two thirds of the sample was aware of WMI in the form of CMI. This is a considerable increase to previous studies
1, 9, and may highlight increased provision of CMI and / or awareness
strategies. However, there is still room for improvement as about a third did not know what a CMI was.
The overwhelming majority of HCPs were aware of CMI. However, there was still a noticeable proportion that did not know about CMI eg 10% of GPs. If we assume that HCPs who knew about WMI completed the survey, and if the figures are projected to the entire population, then the numbers of HCPs who are unaware of CMI is still alarmingly high. These results identify a gap, both in consumer and HCP awareness of CMI. A campaign to educate consumers and HCPs about CMI should be considered as a facilitator in increasing CMI use.
Provision and receipt of CMI
In general, 69% of the consumer respondents reported that they had received CMI for their prescription medicines in the past 6 months, and about 88% of these consumers had received it as a package insert, and just over a third as computer generated CMI from their pharmacists. Very few had received CMI from their doctors. Whilst, the proportion of consumers who reported to have received CMI has increased over the past 8 years, the majority were receiving package insert CMI, with only half of the respondents reporting that they had received a CMI directly from their HCP. The increased involvement of HCPs in the provision of CMI is reassuring as it shows that they are using the CMI document as a source of information more frequently. However, there are still a large proportion of consumers who are not receiving their CMI directly from their doctors or pharmacists, and who may be losing out on evidence-based standardised medicine information. Moreover, just under half of the consumers reported that they have received CMI with their new medicines, and just over a third had received CMI for their repeat prescription medicines. These proportions are lower than the recommended guidelines on the provision of CMI by the PSA. The PSA guidelines recommend that a CMI should be provided to consumers every time a new medicine is provided, and every 6 months for repeat prescriptions. Verbal counselling alone is insufficient to provide all the
Findings:
• A greater proportion of consumers were aware of CMI compared to 5 years ago. • Over two thirds of consumers reported receiving CMI in the last 6 months with about half receiving it in the last month.
The majority reported receiving it as a package insert rather than from their HCP. • About two thirds of consumers receiving CMI reported reading it. • The most common concern reported by consumers when reading a CMI was the side effects. Most reported seeing
their doctor or pharmacist. • A large proportion of consumers wanted the CMI available as a package insert. • About half of consumers reported wanting a CMI for their medicines with 44% only wanting verbal counselling • A third of consumers wanted a summary CMI to be available in addition to the existing CMI. This was in direct contrast
to HCPs who indicated strong support for a summary CMI.
Recommendations:
1. A trial of the Change Management Plan in community pharmacy, to evaluate and refine the workflow strategies, should be conducted using only one CMI format (in order to allow for investigation of the impact of the Plan without the CMI format as a confounder).
2. A program should be developed and implemented by professional organisations i.e. PSA or the Pharmacy Guild to assist, educate and support members to change/modify their practice workflows to encourage CMI provision and use.
3. To establish and maintain the quality of the counselling, guidelines (such as the PSA’s) could be used to develop a checklist of key communication evaluation criteria as well as medicine appropriate criteria to assess and score the pharmacy under the Quality Care Pharmacy Program.
34
FINAL REPORT
information about a medicine to a consumer who has just commenced therapy. Additionally, people’s information needs change with time and duration of therapy. Therefore, it is imperative that HCPs provide consumers with WMI, which can be read and referred to as needed by consumers, especially for long-term therapy.
When questioned specifically about the last CMI they had received, over half of the respondents stated that they had received a CMI in the past month. Based on the PBS and prescription (and repeat) requirements, it would be expected that consumers on chronic therapy would be collecting their prescription once a month. Therefore, receiving a CMI once a month would appear to be satisfactory. However, data were not collected in the survey to identify what medicine the CMI was for and whether consumers were receiving a CMI for that medicine every month. However, it is still reassuring that half of the sample had received a CMI in the month prior to the survey.
All and about 82% of the community and hospital pharmacists, respectively, reported that they had provided CMI. However, only about 69% of the GPs had done so. Overall, more discharge patients received CMI than outpatients; inpatients received the least number of CMI. However, compared to the responses provided by the consumers, it appears that HCPs prefer computer generated CMIs and give those out more than package inserts, while consumers seem to be receiving more package inserts than electronic CMI. This is an interesting finding from self-reported data and requires further investigation.
Comparing HCP data to consumer data on the frequency of receiving CMI, it was interesting to note that similar data were obtained, that is, HCPs tended to give out CMI to consumers on new medicines. However, the tendency in hospital practice was to provide CMI to inpatients, discharge and outpatients only when they asked for CMI.
Readership of CMI
About two thirds of the respondents reported reading the CMI. Readership was found to be influenced by gender (females were more than twice as likely to read the CMI), and how important the following information in the CMI was to them: what the medicine looks like, what the medicine is for, and how to dispose of leftover medicines.
Of those who read the CMI, the majority reported reading most sections of the CMI. The top five sections read (in decreasing order of importance) were what the medicine is for, side effects, before starting the medicine, how to take the medicine and how to store the medicine. With the exception of the last section, the data concur with the responses of the consumer focus group participants. Consumers are therefore interested and do read the CMI, with side effects as the most read piece of information. These findings should be articulated to HCPs so that they are aware of the usefulness of CMI and the interest with which consumers read CMI.
The top five sections discussed (in decreasing order) by community pharmacists, were 1) description of medicine, 2) side effects, 3) how to take medicine, 4) what the medicine is for, 5) drug-drug interactions. The information and order was slightly different for hospital pharmacists: 1), 3), 4), 2) and drug-food interactions; and for physicians 2), 1), 4), 3) and 5). It is reassuring that HCPs are in fact discussing information required by consumers.
Experience in receiving CMI
About a third of consumers received their CMI without any further discussions, whilst a similar proportion received the CMI together with a detailed discussion from their healthcare professional. When use of CMI was explored with HCPs, it was found that very few reported to hand out the CMI without verbal counselling. Whilst this supports the responses provided by consumers, it also raises the concern that a HCP may not provide a CMI because they feel that they do not have adequate time to counsel the consumer using the CMI. This may therefore lead to reduced use of CMI. HCPs should be encouraged to assist provision and use of CMI by setting minimum standards within their practices, such as provision of CMI, highlighting relevant sections for the consumer, asking the consumer to read the information and following up with the consumer either at their next visit or by telephone contact. This may require a practice workflow change, however, it can ensure better use of CMI, and a greater impact of CMI on improved use of medicines by consumers.
The majority of pharmacists reported that they tended to verbally discuss sections of the CMI that they felt were important or drew the consumer’s attention to specific sections of the CMI with some verbal counselling. Whilst these tended to also be the doctors’ most common modes of CMI use, fewer doctors reported doing so. Similar proportions also reported that they tended to provide the CMI and ask the patient to read and return with any questions. A large proportion of HCPs appear to be using the CMI effectively in their practice, the key issue to be addressed, is creating more opportunities for CMI use. This ties in with practice workflow changes to create opportunities for providing and using CMI effectively.
35
FINAL REPORT
The HCPs reported the sections within a CMI that they usually discussed with their consumers (Figure 6).
Figure 6. CMI sections rated as most important by Health Care Professionals
Action taken after receiving CMI
The consumer phone survey reported that over a third of those who had read the CMI reported that they had concerns or queries. The most common concern reported (62%) was that they might experience side effects. However, in nearly all of these cases the consumers sought the advice of their doctor. Some also consulted their pharmacist. A few consumers reported that they changed their medicine dose or the way they took it as a result of reading the information in a CMI. However, large numbers of HCPs: 91.7%, 74.7% and 89.4% of CP, HP and GPs, respectively, reported that their consumers/patients had concerns or queries with the information read in a CMI. HCPs reported the action was that consumers had contacted a pharmacist with their query or concern. Just over a third of pharmacists, and just over half of the GPs, reported that their consumers had contacted a doctor with their query or concern. There were very few reports of changes to therapy as a result of reading CMI.
The data from both consumers and HCPs demonstrated that at least most consumers will contact a HCP with any medicine related concerns or queries, rather than take matters in their own hands. However, the use of the Internet by consumers to address their concerns and queries, is itself a worry, as it is not known what sites were accessed and what the quality of the information was on those sites.
Information needs
Type of Consumer Medicine Information
A large proportion of consumers preferred to receive CMI as a package insert, while just over half preferred to receive a computer generated CMI from their doctor or pharmacist. This may be due to a certainty of receiving CMI with their medicine, without having to rely on a pharmacist; and no requirement to retain the CMI as it is regularly provided with their medicine box. It was interesting to note that about 44% preferred oral counselling. For this large group, CMI may not play a significant role in their quality use of medicines, especially as a larger proportion of the GP and HP samples preferred to provide information verbally as their first preference for information provision.
In contrast, more community pharmacists preferred to print CMI from their computer (first preference) or provide the CMI in the box (second preference) than verbally counsel their consumers. Perhaps, this is one of the issues that restricts the number of CMI provided by community pharmacists. If they are less willing to provide verbal counselling than provide CMI, and if they prefer to give a CMI out when they have the time to counsel, then this may account for the reduced use of CMI observed. This pattern is of concern when over half of the CP respondents as well as about 42% of the HPs, and over a third of consumers believed that pharmacists should provide CMI. About a quarter of consumers believed that the doctor should provide the CMI and about 23% felt that both pharmacists and doctors should provide it.
Only 50% of consumers responding to the survey reported that they would like to receive CMI for any of their prescription medicines. Of these respondents, a third preferred to receive their CMI from their pharmacist and just over 20% preferred package inserts without any interaction with a healthcare professional. Policy makers and consumer and professional organisations should be made aware that CMI may not be the ‘information answer’ for all consumers and that there is a large group of consumers who prefer verbal counselling. Moreover, there are a group who just want to receive the information with no interaction. A way of addressing these needs would be to have CMI available as package inserts and /or at a website accessible by all consumers. However, the option of CMI with or without verbal counselling should be offered to all consumers collecting prescription medicines.
9389
77
93
57
99
8387
60
83 84
60
51 52
4549
56
30
49
3843
32
47
29
0
10
20
30
40
50
60
70
80
90
100
Community Pharmacist Hospital Pharmacist General Practitioner
% Resondents
N=349 N=167 N=179
Side effects
Description of medicine
How to take the medicine
What the medicine is for
Drug-drug interactions
Drug-food interactions
Points to note before starting the medicine
Missed dose
36
FINAL REPORT
Provision and use of CMI
The majority of HCPs believed that CMI should be given out when consumers have been prescribed / dispensed a new medicine and when new information has become available. Most of the HPs felt that discharge patients should receive their CMI from the community pharmacist. It might be assumed that consumers on new medicines are more likely to receive CMI, while those on repeat medicines may miss out. Equally those on repeat medicines may also miss out on HCPs’ verbal counselling. This poses a risk to the quality use of medicines by consumers on repeat medicines, who may experience problems or have issues with medicine taking later in their treatment and when HCPs may assume that ‘all is going well’ with their therapy.
Interestingly none of the GP respondents believed that the doctor should provide CMI. This is concerning as consumers indicated a strong desire to receive information from the GPs. The HCPs desired use of CMI as a counselling tool mirrored their reported use of CMI. The majority of HCPs preferred to verbally discuss sections of the CMI that they felt were important or draw attention to specific sections with some verbal counselling. These methods are perhaps more effective in highlighting the value of CMI and its information content, and increasing consumer knowledge and understanding of the information, rather than going through an entire CMI in one consultation or not interacting with the document at all. Not interacting with the CMI as part of the verbal counselling may diminish the value of the CMI and interaction for the consumer consequently resulting in consumers preferring to receive the CMI in the box.
CMI content
Consumers and HCPs rated all sections of the CMI as important and the order of importance of information was similar between HCPs and consumers. The top seven information sections which were rated as very important by between 75-92% of the consumer respondents were (in decreasing order of importance): 1) side effects, 2) action to take if a side effect occurs, 3) how to take the medicine, 4) drug-drug interactions, 5) what the medicine is for, 6) before starting the medicine, and 7) drug-food interactions.
In terms of the side effects information presented, both consumers and HCPs preferred to see the information listed as ‘common’, ‘infrequent’ and ‘rare’. About a third of consumers also preferred to see the incidence of side effects presented as percentages. However, fewer HCPs preferred this, perhaps because they thought that consumers may not understand, or that they may need to spend more time explaining the information to them.
CMI format
About half of the consumers preferred a comprehensive CMI as is currently available, and over a third preferred a summary CMI but with access to the comprehensive CMI if necessary. Support for a comprehensive CMI, however, was limited amongst the HCPs. About a third preferred a summary CMI in the box, with access to a comprehensive CMI if necessary, and only a third of CPs and HPs preferred a summary CMI in the dispensing software too. There was little support from the GPs for a summary CMI in their prescribing software. A majority of HCPs believed that the pharmacist should provide the summary CMI. This supports the other findings of the survey where HCPs believed that pharmacists should provide CMI. In contrast, half of consumers thought that the summary CMI version should be located in the medicines box, about a third thought that doctors should also provide the summary when they prescribe a new medicine, while only a quarter thought that pharmacists should provide the summary version when dispensing.
4. Limitations Although all efforts were made to ensure that study participants were representative of the general population, differences in reading ability, education, health literacy and personal preferences could not be entirely predicted for all participants, however in several stages participants did closely correlate with ABS data.
Unfortunately, this study could not include a segment of Australian users of medicines because, due to the nature of the subject (Consumer Medicine Information) it predominantly dealt with people with assumed levels of basic literacy and competency in speaking the English language. Furthermore, health literacy of the consumer participants was not assessed, and therefore the data could not be correlated with health literacy and literacy levels
Recommendations:
1. Education programs, supported by various professional bodies on the importance of CMI to consumers and specific information consumers need when counselled, should be developed and implemented nationally.
2. HCPs awareness of CMI should be increased through articles and regular information in professional publications as well as training programs connected to CPE / CPD points.
3. The findings of this research project should be distributed widely to professional and consumer organisations to encourage and promote CMI awareness and provision.
4. Consideration should be given by pharmaceutical manufacturers, based on the strong response by consumers and HCP, to increasing the availability of CMI as package inserts.
37
FINAL REPORT
of, or generalised, to the entire Australian population. A means of addressing this would be through a method of basic literacy and health literacy questions that could be incorporated into further studies, as opposed to relying on education levels attained. However, the nature of CMI is such that consumers of low literacy and / or health literacy may not be able to participate, unless CMI is written to cater for information needs of consumers with varying levels of literacy and health literacy.
In regards to the focus groups, while the study was completed to theoretical saturation, it may be possible that issues and subtle differences of views in a small proportion of the population may not have been identified. Moreover, the focus group research was qualitative in nature and not generalisable to the entire population. Additional, focus group attendance was voluntary and people often self select to participate, potentially resulting in an overrepresentation of people interested in medicine information. Therefore, the quantitative surveys were conducted with consumers and HCPs as part of the Needs Analysis, to address these limitations.
It was an unfortunate outcome of unforseen circumstances that the Workflow Change Management Plan could not be assessed during the CMI trial. On the other hand, to appropriately evaluate the Plan, a larger Trial would have been required which could assess the impact of the Plan on CMI provision without the alternative CMI formats acting as confounders. It is the hope of researchers that this may be possible in the future.
5. Conclusions The iterative process of evaluating, designing and testing the alternative CMI, where development involved an information design, functional linguistic and medicine information expertise, and where the testing included user-testing, produced alternative CMI formats which performed better and were easier to read and comprehend. The development process was informed by a detailed needs analysis of the key stakeholders, including consumers and healthcare professionals.
The challenges associated with CMI are multi-factorial. In order to improve medicine information provision, the document itself needs to be improved in parallel with attempts to increase awareness and up-skill healthcare professionals in how to optimise the use of CMI as a tool in improving consumers’ quality use of medicines.
Regulators and producers of medicine information need to involve consumers in the process of producing medicine information so that their needs and views are better reflected. Information design experts and the use of information design principles should be utilised in developing CMI. Content wording and readability needs to be addressed to ensure clear, concise and easy to understand documents. Performance rating through the process of user testing should be considered standard routine practice in order to produce high quality CMI. Additionally, consideration should be given to alternative styles and avenues of CMI provision and monitoring.
Addressing the barriers and facilitators, and driving a process of implementing change strategies into community pharmacy are necessary ingredients in improving the overall provision of CMI. Consumers also need to take responsibility for their medicine information needs by demanding CMI from their HCPs in order to force change in work practices. A process of education of HCPs and the promotion of consumer health literacy in order to enhance health outcomes is an important factor in promoting and sustaining provision of CMI. The availability of CMI in other languages, literacy levels and other mediums may also need to be a focus of further research.
Consideration should also be given to the long-term processes of evaluation of CMI, in particular its actual impact on consumers’ quality use of medicines. CMI should become an integral part of the continuity of care. All pharmacists and doctors should be encouraged to support each profession’s use of CMI, refer consumers to the appropriate healthcare professional for CMI, set up mechanisms of addressing consumer queries and concerns in their practices, and follow up consumers with regard to their medicine information needs.
Overview of Recommendations
Short term
1. The findings of this research project should be distributed widely to professional and consumer organisations to encourage and promote CMI awareness and provision.
2. The findings of the project on the development and evaluation of the new alternative CMI formats should be used to inform and consolidate changes in the Usability Guidelines. This process should include consultations with a broad group of stakeholders, specifically the CMI QARG.
3. The use of current Usability Guidelines in the production of CMI should be a minimum standard of practice by all pharmaceutical manufacturers in order to improve format and readability of CMI.
38
FINAL REPORT
4. The conduct of user testing by pharmaceutical companies should be strongly encouraged for all CMI. 5. Consumer consultation on the scope and content should become standard practice during all stages of CMI
development and testing. 6. The current Core CMI should be reviewed and key aspects of the new alternative formats adopted into the
Core CMI. A committee to review this could be set up under existing groups such as QARG. Funding for this group would be essential in order to employ a dedicated team to thoroughly evaluate the new Core CMI.
7. The development of CMI should be an individually reviewed process with particular attention given to: a. structure, bullet points and use of bold to improve readability; b. layout and design of CMI, to include features such as: boxed contact information, side effects tables; c. clear headings (such as reverse tiering) and sub-headings; and d. specific sub-headings relating to pregnancy, food and driving, to improve localisation and
comprehension.
Medium term
8. Consumer awareness should be increased through: a. Focused high intensity and ongoing media campaigns promoting awareness of CMI availability. b. A single prominent and user-friendly Internet based repository for consumers. The address for this
should also be listed on each CMI. c. Verbal promotion by HCPs during consultations.
9. HCPs awareness of CMI should be increased through articles and regular information in professional publications as well as training programs connected to CPE / CPD points.
10. A trial of the Change Management Plan in community pharmacy, to evaluate and refine the workflow strategies, should be conducted using only one CMI format (in order to allow for investigation of the impact of the Plan without the CMI format as a confounder).
11. To establish and maintain the quality of the counselling, guidelines (such as the PSA’s) could be used to develop a checklist of key communication evaluation criteria as well as medicine appropriate criteria to assess and score the pharmacy under the Quality Care Pharmacy Program
Longer term
13. A key facilitator to the provision and use of CMI expressed by both healthcare professionals and consumers was the provision of a summary CMI. Further development and evaluation of a summary CMI should be considered in order to determine its viability. The summary CMI may be available in the medicine box, Internet and prescribing and dispensing software. This should be in addition to the existing CMI.
14. Time management strategies for pharmacists such as changed practices, caps on dispensing limits for pharmacists, automated systems and increased staffing levels, should be evaluated.
15. A HCP education package to increase CMI awareness and foster CMI use with consumers should be implemented. The education package should include on-going assistance and strategies to incorporate CMI into daily practice.
16. The desire by both HCPs and consumers for information to be available on positive benefit information and for clearer side effect reporting should be evaluated and researched further.
17. Investigations should be made into how dispensing and prescribing software may be streamlined to automatically prompt and record CMI provision.
Implementing the Recommendations
Time Frame Recommendation Procedure
Stage 1
(Immediate)
Increase CMI awareness The findings of this research project to be distributed widely to professional and consumer organisations to encourage and promote CMI awareness and provision. The platform for this should include professional publications, newsletters and journals
Establish a working committee to review and revise the Usability Guidelines, in light of the findings of the research project.
This committee should
The use of current Usability Guidelines in the production of CMI to be made the minimum standard of practice by all pharmaceutical manufacturers in order to improve format and readability of CMI.
Review and revise the findings of this study in order to inform changes in the Usability Guidelines. Specific areas of consideration to include:
• Consumer consultation on the scope and content of CMI
39
FINAL REPORT
include all relevant key stakeholders in the area of CMI (eg. Consumers, healthcare professionals, pharmaceutical industry, policy makers, CMI QARG)
development and testing. • Review and revision of the current Core CMI with key aspects of
the new alternative formats adopted into the revised Core CMI. • The development of CMI should be an individually reviewed
process with particular attention given to: o structure, bullet points and use of bold to improve readability; o layout and design of CMI, to include features such as: boxed
contact information, side effects tables; o clear headings (such as reverse tiering) and sub-headings;
and o specific sub-headings relating to pregnancy, food and driving,
to improve localisation and comprehension. • The functional linguistics recommendations to be reviewed and
incorporated into the current Usability Guidelines.
(See Appendix 20 and 21 in Final Report)
User testing as a gold standard
The conducting of user testing by pharmaceutical companies should be considered the gold standard for all CMI development.
Stage 2
(Longer Term)
Broadening of the CMI Awareness Campaign
Consumer awareness should be increased through:
• Focused high intensity and ongoing media campaigns promoting awareness of CMI availability.
• A single prominent and user-friendly Internet based repository for consumers. The address for this should be listed on each CMI.
• Verbal promotion by HCPs during consultations.
HCPs awareness of CMI should be increased through articles and regular information in professional publications as well as training programs connected to CPE / CPD points.
Implementing Practice Change
A trial of the Change Management Plan in community pharmacy, to evaluate and refine the workflow strategies, should be conducted using only one CMI format (in order to allow for investigation of the impact of the Plan without the CMI format as a confounder).
As lack of time was considered a significant barrier to CMI provision, time management strategies for pharmacists such as changed practices and systems, and increased staffing levels, should be evaluated.
Implementing CMI into QCCP Accreditation
To establish and maintain the quality of the counselling, guidelines (eg the PSA’s) could be used to develop a checklist of key communication evaluation criteria as well as medicine appropriate criteria to assess and score the pharmacy under the Quality Care Pharmacy Program (QCPP).
Improving CMI provision through HCP education strategies
A HCP education package to increase CMI awareness and foster CMI use with consumers should be implemented. The education package should include on-going assistance and strategies to incorporate CMI into daily practice.
Further research A key facilitator to the provision and use of CMI expressed by both healthcare professionals and consumers was the provision of a summary CMI. Further development and evaluation of a summary CMI should be considered. Summary CMI use in a variety of circumstances, such as, as an initial counselling tool, availability through the Internet, availability through prescribing / dispensing software and as a package insert, should be further considered.
The desire by both HCPs and consumers for information to be available on positive benefit information and for clearer side effect reporting should be evaluated and researched further.
40
FINAL REPORT
References:
1. Benton M, Snow K, Parr V. Evaluation of the Medicines Information for Consumer (MIC) Program: Pharmacy Guild of Australia; 2004.
2. Therapeutic Goods Regulations. (1993a). Part 2A- Patient Information, Regulation 9A.
3. Therapeutic Goods Regulations. (1993b). Schedule 12- Patient Information Documents.
4. Vitry A, Gilbert A, Mott K, Rao D, March G. Provision of medicines information in Australian community pharmacies. Pharm World Sci 2009;31:154-7.
5. Australian Pharmaceutical Formulary and Handbook (2006). 19th ed: Pharmaceutical Society of Australia.
6. Commonwealth Department of Human Services and Health (1995). General guidelines for health professionals on Consumer Product Information: Australian Government Publishing Service; May.
7. Standards of Practice for the Provision of Consumer Medicines Information by Pharmacists in Hospitals Australian Journal of Hospital Pharmacy 2000;30 225-8.
8. The Pharmacy Guild of Australia. www.guild.org.au/public/cpa/.
9. Koo M, Krass I, Aslani P. Consumer use of Consumer Medicine Information. Journal of Pharmacy Practice Research 2005;35:94-8.
10. Koo MM, Krass I, Aslani P. Patient characteristics influencing evaluation of written medicine information: lessons for patient education. Ann Pharmacother 2005;39:1434-40.
11. Aslani P, Benrimoj S, Krass I. Development and Evaluation of a training program to foster the use of written drug information in community pharmacies- Part 1- Development. 6(1) pp41-52. Pharmacy Education 2006;6:41-52.
12. Raynor DK, Svarstad B, Knapp P, et al. Consumer medication information in the United States, Europe, and Australia: a comparative evaluation. J Am Pharm Assoc (2003) 2007;47:717-24.
13. 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:iii, 1-160.
14. Luk A, Tasker N, Raynor DK, Aslani P. Written medicine information from english-speaking countries--how does it compare? Ann Pharmacother 2010;44:285-94.
15. Koo MM, Krass I, Aslani P. Evaluation of written medicine information: validation of the Consumer Information Rating Form. Ann Pharmacother 2007;41:951-6.
16. Halliday M, Matthiessen CMIM. An introduction to Systemic Functional Linguistics 3rd ed: London, Edward Arnold.; 2004.
17. Halliday MAK. Explorations in the Functions of Language: London: Edward Arnold; 1973.
18. Raynor DK, Dickinson D. Key principles to guide development of consumer medicine information--content analysis of information design texts. Ann Pharmacother 2009;43:700-6.
19. Sless D. Usable medicines information. In: Communication Research Institute of Australia; 2001.
20. Australian Bureau of Statistics. A Picture of a Nation: the Statisticians Report on the 2006 Census. Australian Bureau of Statistics; Canberra; 2006.
41
FINAL REPORT
21. Sless D, Shrensky R. Writing about Medicines for people in: Usability guidelines for consumer medicine information. 3rd ed: Australian Self-Medication Industry; 2006.
22. Horne R, Hankins M, Jenkins R. The Satisfaction with Information about Medicines Scale (SIMS): a new measurement tool for audit and research. Qual Health Care 2001;10:135-40.
23. Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich) 2008;10:348-54.
24. Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med 2004;36:588-94.
25. Chew LD, Griffin JM, Partin MR, et al. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med 2008;23:561-6.
26. Australian Bureau of Statistics. Australian Demographic Statistics; http://www.abs.gov.au/AUSSTATS/[email protected]/DetailsPage/3101.0Jun%202008?OpenDocument#Publications June 2008.
27. Wiseman R, Hourigan M. Testing and revising the Lipitor CMI: Research+Evaluation+Design 3; 2007.
47
FINAL REPORT
Appendices Appendix 1. Key Stakeholder Groups
Communication Research Institute of Australia Australian Self Medication Industry Pfizer Australia Alphapharm Pty Ltd PSA NSW MIMS Australia St Vincents Hospital Medicines Australia Diabetes Australia Diabetes Australia - NSW Diabetes Australia - QLD Diabetes Australia - VIC Diabetes Australia - SA Diabetes Australia - Tasmania Diabetes Australia - WA Australian Diabetes Educators Association Juvenile Diabetes Research Foundation Australia Heart Foundation National Stroke Foundation National Breast Cancer Centre RACGP College House - National Rural Faculty The Asthma Foundation of Victoria Diabetes Australia Arthritis Australia Council On the Aging Cystic Fibrosis Australia Parkinson's Australia Leukaemia Foundation Australia The Australian Lung Foundation Myeloma Foundation Australia Prostrate Cancer Foundation Australia Australian Pituitary Foundation Epilepsy Action Australia Mental Health Council of Australia MS Australia (QLD) MS Australia (WA) depressioNet Australian Federation of AIDS Organisations Federation of Ethnic Communities Councils of Australia Inc Health Consumers of Rural and Remote Australia Inc Health Issues Centre RACGP College House RACGP College House (NSW and ACT) RACGP College House (Victoria) RACGP College House (South Australia and Northern Territory) Alzheimer's Australia Breast Cancer Network Australia Kidney Health Australia Australian Cardiovascular Health and Rehabilitation Association Australian Healthcare and Hospitals Association Australian Primary Care Community Partnerships Inc beyond blue Australasian Society for HIV Medicine Mental Health Co-Coordinating Council Mental Illness Fellowship of Australia
Palliative Care Australia Royal College of Nursing Australia Society of Hospital Pharmacists of Australia RACGP College House (Queensland) RACGP College House (Western Australia) RACGP College House (Tasmania) Australian College of Rural and Remote Medicine Cancer Voices NSW National Asthma Council Australia The Pharmacy Board of NSW The Pharmacists Board of Queensland The Pharmacy Board of Victoria The Pharmacy Board of South Australia The Pharmaceutical Council of Western Australia The Pharmacy Board of Tasmania The Pharmacy Board of the Northern Territory The Pharmacy Board of the ACT Pharmaceutical Defence Limited Australian Pharmacy Council Australian General Practice Network ACT Division of General Practice Network General Practice NSW NSW Rural Doctors Network General Practice Network NT General Practice Queensland General Practice Network SA General Practice Tasmania Ltd General Practice Network Victoria WA Centre for Rural and Remote Medicine WA General Practice Network Epilepsy Action Australia ME/Chronic Fatigue Syndrome Association Ltd Asthma Foundations Australia Health Consumers' Council WA (Inc) Australian Crohns and Colitis Association Thyroid Australia Cancer Council ACT Cancer Council Northern Territory Cancer Council South Australia Cancer Council Victoria Cancer Council NSW Cancer Council Queensland Cancer Council Tasmania Cancer Council Western Australia MS Australia (ACT) MS Australia (NSW) MS Australia (VIC) MS Australia (SA and NT) MS Australia (TAS) Cancer Voices Queensland Cancer Voices Victoria Cancer Voices South Australia Continence Foundation of Australia Heart Support Australia Hepatitis Australia Chronic Illnesses Alliance
48
FINAL REPORT
Appendix 2. Focus Group Protocol Example (Consumer)
Faculty of Pharmacy
Investigating Consumer Medicine Information Focus Group Question Guide Objectives of the research study: 1. To qualitatively evaluate the different forms of written medicine information provided. 2. To identify and qualify barriers and facilitators to the effective use of CMI in community pharmacy practice 3. To identify consumers’ needs and expectations of medicine information related to the quality use of medicines. Question 1: What do you think are consumers’ needs with regard to medicine information in order to be able to use their medicines appropriately and effectively? Question 2: What do you think are consumers’ expectations with regard to medicine information that they receive from health professionals in order to be able to use their medicines appropriately and effectively?
• existence and availability of CMI?
• how often you receive CMI? What do you do with it? Eg. Keep it, throw it away et.
• Do you seek medicines information and where? Eg. GP, pharmacist, Internet (what sites?), other.
• Who do you want to receive CMI from and when? Question 3: Looking at the various CMI presented which come from English speaking countries, what do you think about this information? Comments sought on:
• the design and layout;
• how easy is it to scan and find information;
• how easy is it to read and understand; Question 4: How do you think CMI as a document can be changed to assist its use by consumers? (focusing on layout, design, presentation as well as content) What content could be added or removed? Question 5: Thinking about written medicine information that you may have received:
a. what do you think are some of the barriers to it being given out by health professionals such as doctors and pharmacists?
b. what do you think are some of the barriers to it being used in consultation by health professionals such as doctors and pharmacists?
Question 6: Thinking about written medicine information that you may have received:
a. what do you think are some things that may encourage it being given out by health professionals such as doctors and pharmacists?
b. what do you think are some things that may encourage it being used in consultation by health professionals such as doctors and pharmacists?
Question 7: What do you think are some of the barriers to CMI being used by you or other consumers? (eg. Literacy, ESL etc.) Question 8: What do you think are some things which help encourage CMI to be used by you or other consumers? (eg. Available in different languages etc.) Question 9: What other ways or forms other than written could you suggest that the CMI could be presented? Question 10: What other ways do you think could encourage awareness of CMI?
49
FINAL REPORT
Appendix 3. Information Design Brief based on Needs Analysis
A. Layout
Headings
- bold, short, clear headings - reverse type - the background is printed instead of the type i.e. black
background, white type - some wanted headings as a question, eg What is your medicine for? - some wanted topics headed with a positive i.e. How this medicine
helps you
White space
- sufficient white space, especially around the edges - document not to appear ‘squashed’ in or busy looking as this makes it
feel unapproachable or complicated to some
Bullet Points
- use of bullet points for lists of information rather than continuous text - some preferred numbering rather than bullet points to indicate
importance eg with side effects information - lists with bullet points should not be too long, and not be running over
several lines
Columns
- 2 column on A4 page was the most preferred format, followed by 3 column on A4 page format
- only one person preferred a single column
Emphasis
- most liked use of bold for important points, although many felt too much bold was distracting
-
Pictures and Graphics
- many participants wanted important information located in a box on the front page
- many wanted a boxed summary or ‘Frequently Asked Questions” section on the front page
- some felt that warnings and precautions should be boxed and highlighted
- some people wanted coloured pictures of the medicine in the CMI - one or two people felt the use of pictures and cartoon graphics may
assist those with literacy issues - most liked the side effects set-up in a table format giving action to be
taken against side effect (illustrated below). Possible Side Effects
Action to Take
Common - Diarrhoea, headache etc
If side effects worry you and don’t go away contact your doctor or pharmacist
Serious - Chest pain, irregular heart beat
Contact pharmacist/doctor promptly
Rare - Stiff muscles, high fever Immediately contact doctor or go to hospital
Navigation Aids
- use of list of contents on front page - numbering of headings to correspond to content list
Organisation
- clear structure of what is in document - summary of medicine information contained within a box on the front
page - side effects on the first page (as this is the information that
consumers are primarily interested in) - warnings/precautions on the first page - question and answer scenarios were preferred by some consumers
50
FINAL REPORT
- booklet style - clearly distinguish between sections in the document - sections to finish on a page, not continue on to the next so as the
information is not missed
B. Length
Line Length
- shorter lines were preferred, however many did not like the line length in 3 column as it was too short and appeared like a newspaper
- single column line length was too long and too difficult to read; it appeared overwhelming
Line Spacing
- well-spaced and clear was preferred - if the spacing was too condensed some focus groups participants
commented they felt something was being ‘hidden’ in the document
Document Length
- single page most preferred - must be no more than 2 or 3 pages length at most
C. Type
Font
- most did not like the serif font (Times New Roman or Courier) - sans serif font preferred - brand name should not be in bold or capitals
Font Size
- adequate font size was important ie 10 -12 point as a minimum - font size in the package insert written information documents was too
small to read
Colour
- use of colour to emphasise important points
- use of colour to emphasise sections e.g. the suggestion of red to highlight important sections or each section individually colour coded (no specific colours suggested)
51
FINAL REPORT
Appendix 4: Consumer Phone Survey
Investigating Consumer Medicine Information (CMI) Questionnaire (Consumer)
Interviewer: Firstly, just a reminder that you may withdraw from this survey at any time should you so wish. Now, I would like to start by defining what consumer medicine information is, before asking you a series of questions about consumer medicine information
Consumer Medicine Information (or CMI as it is called for short), is manufacturer produced written information about medicines that comes with prescription and some over-the-counter medicines. The CMI provides you with specific information about your medicines. The CMI comes in three different forms: a printed sheet inside your medication box, a loose leaflet given to you with the medication or a computer print out given to you at the pharmacy or the doctor.
1. Did you, prior to now know what Consumer Medicine Information (or CMI for short) is? � Yes � No
2. The CMI is available from several places. Please tell me, from the following list where you think consumers may get a CMI from? (You may choose more than one option) � Pharmacist � Doctor � Pharmaceutical Company website � Internet � Inside the medicines box � Other (please specify_______________________) 3. Have you received a CMI for any of your prescription medicines in the last six months? � Yes ---------- Interviewer - Go to Q4 � No ---------- Interviewer – Go to Q16 � Don’t know ---------- Interviewer - Go to Q16 4. If you think back to those CMI that you have received, what types were they? (You may choose more than one option) � Package inserts in the medicine box � Computer generated manufacturer produced CMI print-outs from your doctor or pharmacist � Computer generated information OTHER than a CMI from your doctor or pharmacist � Loose leaflets / brochures � Other (please specify __________________) 5. Who provided you with those CMI for your prescription medicine(s)? (You may choose more than one option) � Pharmacist � Doctor � Pharmacy assistant (Interviewer: Do not ask Q8 if this is answered) � None of the above as it was inside the medicine box (Interviewer: Do not ask Q8 if this is answered) � Family member, friend or carer (Interviewer: Do not ask Q8 if this is answered) 6. How often would you say that you are generally provided with a CMI from your pharmacist? (You may choose more than one option) � Every time you get a new medicine � Every time you collect a repeat prescription for a regular medicine � Every 6 or 12 months for repeat prescription (please specify time___) � Only when you ask for it 7. Have you ever been offered a CMI for your medicine and not wanted it? � Yes ----------- How often would you say this has happened? ___________ � No Interviewer: We would now like to explore the last time you received a CMI and find out what happened. Do you remember when you received your last CMI? (please specify if recalled_____________ )
52
FINAL REPORT
8. The last time you were provided with a CMI by your doctor or pharmacist, … (Interviewer: Only ask this question if pharmacist or doctor was answered in Q5) � It was handed out to you with no further discussion. � Sections of the CMI were pointed out to you � You were asked to read the CMI and come back if you had any questions. � The entire content of the CMI was discussed in detail with you by the pharmacist or doctor. 9. Do you usually read the CMI? � Yes ---------- Interviewer - Go to Q10 � No ---------- Interviewer - Go to Q15 10. I am now going to read out a list of what is in the CMI. Could you please tell me whether you usually read this information? (Please answer yes or no for each) Yes No List of the contents of the leaflet � � What the medicine is for � � Before starting the medicine � � How to take the medicine � � Drug-drug interactions � � Side effects � � How to store the medicine � � How to dispose of leftover medicine � � What the medicine looks like � � What the ingredients are � � Manufacturer contact details � � Interviewer: The next few questions refer to any concerns you may have had after reading a CMI. 11. Have you had any concerns or queries after you read a CMI? � Yes --------- Interviewer - Go to Q12 � No --------- Interviewer - Go to Q15 12. What were your concerns? (You may choose more than one option) � Experiencing the side effects � Having allergies to the medicine or other ingredients � Experiencing interactions with other medicines you were also taking � It was not the right medicine for you � Other (please specify ________________________________) 13. What did you do to address your concerns or queries? Did you………… (You may choose more than one option) � Contact your pharmacist --------- Interviewer - Go to Q14 � Contact your doctor --------- Interviewer - Go to Q14 � Contact another health care professional --------- Interviewer - Go to Q14 � Consult a friend or relative. --------- Interviewer - Go to Q15 � Search for more information (please specify where _________________Interviewer - Go to Q 15 � Make changes to the way you took the medicine (please specify what ____________Go to Q15 � Other (please specify_________________________________________Interviewer - Go to Q15 14. What happened after you contacted your pharmacist (or doctor or other health professional)? � There was no change in the way you were instructed to take your medicine. � Your medicine was stopped. � The dose of your medicine was changed. � The medicine itself was changed. � Other (please specify_________________________________) 15. Interviewer: There may be times when you do not read a CMI for your medicine. Would that apply to you? � Yes --------- Interviewer Go to Q15a � No --------- Interviewer Go to Q16
53
FINAL REPORT
15(a) What are your reasons for not reading a CMI? (You may choose more than one option) � You receive all the information you need from your doctor or pharmacist. � You trust your doctor or pharmacist to provide a medicine that is suitable for you. � You have taken the medicine previously � You are only taking the medicine for a short time (less than 2 weeks) � There is too much information in the CMI � The CMI is too long to read � Other (please specify)__________________ Interviewer: I would now like to explore whether you would like to receive a CMI for your prescription medicine(s), how and when. 16. Firstly, I will read you a list of possible sources of medicine information. Please tell me which TWO sources you most prefer? (Interviewer: you may choose up to TWO options) � Computer printed written medicine information from your doctor or pharmacist � Printed information in the medicine box � Verbal information from your doctor or pharmacist � Handwritten information from your doctor or pharmacist � A website you find yourself on medicines � A website recommended to you by your doctor or pharmacist � A Medicine Reference book � Other (please specify _____________________________) 17. Specifically, would you like to receive a CMI for any of your prescription medicines? � Yes ---------- Interviewer - Go to Q18 � No ---------- Interviewer - Go to Q21 � Don’t know ---------- Interviewer - Go to Q21 18. Who would you like to receive the CMI from? � Your doctor � Your pharmacist � Both doctor and pharmacist ………………….Interviewer – Go to Q20 � Neither ---------------------------------------- Interviewer - Go to Q20 � You would like it in the medicine box ---------- Interviewer - Go to Q21 � Obtained from an Internet website ---------- Interviewer - Go to Q21 19. Why do you think this person/s is the best person to provide you with CMI? (You may choose more than one option) � Your doctor/pharmacist is an expert on medicine(s) � Your doctor/pharmacist sees you on a regular basis � You have a good relationship with him/her � Your doctor/pharmacist is aware of your medical history and/or medicines � You have paid him/her for his/her time � He/she has more time to talk to you � He/she is easier to access anytime � You are more comfortable in discussing your medicines with him/her � Other (please specify ________________________________) 20. When would you like to receive a CMI for your prescription medicines? (You may choose more than one option) � The first time you get a new medicine � Every time you collect a repeat prescription � Every 6 or 12 months for repeat prescriptions (please specify_____________________) � When new information about the medicine becomes available � Only when I ask for it � Other (please specify____________________________) Interviewer: The next few questions will aim to discover what specific information you want to know about your medicines.
54
FINAL REPORT
21. Can you rate how important it is to you to receive the following information about your medicine, in order to be able to take your medicine correctly? The choices are “not important”, “somewhat important” or “very important” to you. Not Somewhat Very Important Important Important Drug name and all brand and generic names � � � List of the contents of the leaflet � � � What the medicine is for � � � Before starting the medicine � � � How to take the medicine � � � Benefits of taking the medicine � � � Drug-drug interactions � � � Food Interactions � � � Side effects � � � Action to take if a side effect occurs � � � How to store the medicine � � � How to dispose of leftover medicine � � � What the medicine looks like � � � What the ingredients are (eg Lactose, gluten) � � � Manufacturer contact details � � � Others (please specify ________________________) � � � 22. Side effects are often a concern for consumers. What do you think would be the best way of reporting them to help consumers understand the information? � Listed as common, infrequent and rare side effects � Listed as a number for example. 3 in 100 people have experienced a cough with this medicine � Listed as a percentage for example. 3% of people have experienced a cough � Compare to consumers NOT taking the medicine in clinical trials for example 3% of people taking the medicine
experienced a cough compared to 3% taking sugar pills. � Not sure 23. If you think about receiving written information with your medicines, what would be your preferred format? I will read out four options: � A summary of important points about the medicine � A summary of important points about the medicine INITIALLY, but able to access a comprehensive CMI from
your doctor/pharmacist or recommended website � A comprehensive document like the CMI currently available------Interviewer - Go to Q25 � None of the above --------- Interviewer - Go to Q25 24. How would you like this summary CMI to be provided? (You may choose more than one option) � In the medicines box � By the doctor at the time of prescribing the medicine � By the pharmacist on dispensing the medicine � Only with new medicines � Only when you ask for it 25. Some doctors and Pharmacists fail to give out CMI. Can you tell me from the following list reasons that YOU think doctors and pharmacists may not give out CMI to consumers. (You may choose more than one option) � They have limited time or are too busy � They are not your regular doctor/pharmacist � They are not interested in giving CMI out � They may be concerned you will not take the medicine � The CMI is too long to print off for them � They may be concerned that the information may be difficult to understand or read � They do not think consumers need to know more than what they tell them � They may be concerned that consumers may ask too many questions � Other reasons ( please specify ___________________________)
55
FINAL REPORT
26. What do you think may encourage your doctor and/or pharmacist to provide you and other consumers with CMI? (You may choose more than one option) � For Consumers to become more aware of the CMI and ask for it � Pharmacists/ doctors to devote more time to provide and explain CMI � If consumers could make an appointment with the pharmacist to talk about their medicines � If the pharmacies have a private area for the pharmacist to discuss the CMI � Having a summary CMI covering important points about the medicine � Having a regular pharmacist or doctor who knows the consumer well � Having CMI in different languages � Having a self serve computer in the pharmacy or surgery to print CMI � If consumers paid for the CMI � Other (please specify____________) 27. We would like to increase consumers’ awareness of CMI. Which of the following do you think could increase consumers’ awareness of the CMI and where CMI can be accessed? (You may choose more than one option) � Doctors and pharmacists referring to it � TV advertising � Radio advertising � Print media eg.newspapers, magazines, brochures � Posters in pharmacies or doctors surgeries � Promoted on prescriptions � Repeat prescriptions backing cards from pharmacies � Other (please specify _____________________________________) Interviewer: The remaining questions collect some demographic details about you. We would appreciate if you would please answer all questions. The information collected is for the sole use of this project. 28. Sex: Male �
Female �
29. How old are you? ____ years 30. What country were you born in? Australia � Overseas � please state 31. What is the main language you speak at home? English � Other � please state 32. What is the highest level of education that you have achieved? School Year 10 or below � School Year 11 or 12 � TAFE or Certificate I-IV �
Tertiary (Diploma, Bachelor or higher) � 33. What is your main occupation? Please specify___________________________ 34. What is the postcode of where you live? Please specify___________________________ Interviewer: Thank you for participating in this study. Your time is greatly appreciated and your input is highly valued. If you wish to receive any further information please contact the Investigating Consumer Medicines Project on 02 9909 0620.
56
FINAL REPORT
Appendix 5. Community Pharmacist Survey
57
FINAL REPORT
58
FINAL REPORT
59
FINAL REPORT
60
FINAL REPORT
61
FINAL REPORT
62
FINAL REPORT
63
FINAL REPORT
64
FINAL REPORT
Appendix 6. Lipitor User Testing Questions – Example
Q # Show card Question Indicative answer Note to interviewer
1 What is Lipitor used for? To lower the amount of fats in your blood
Prompt: What does it do to the amount of fats? (if participant does not say lower)
2 What is the usual dose of this medicine?
Need BOTH: // i) between 10 and 80mg // ii) once a day
Prompt: How many times per day?
3 What other things could you do to help keep your cholesterol low?
TWO of 3 required:// i) follow a low fat diet// ii) exercise// iii) maintain a healthy weight // iv) stop smoking
4 Lactose Imagine you have an allergy to one of the ingredients in this medicine called ‘Lactose’. What does the leaflet say about using this medicine?
Do not take Lipitor
5 Imagine you (are female) are on this medicine and find out you are pregnant. What does the leaflet say you should do?
NEED BOTH: Stop taking it AND talk to your doctor immediately
Note: if they read out the whole section - ask to clarify what they should do
6 What may cause your cholesterol levels to become too high?
BOTH: // i) If your body makes too much cholesterol // ii) you eat too much fat in your diet
7 What does the leaflet say may occur if you drink large amounts of alcohol when you are taking this medicine?
It increases your chance of Lipitor causing liver problems
8 Why may you need to keep taking this medicine for the rest of your life?
EITHER: // i) It is not a cure for your condition // ii) to keep your cholesterol at a healthy level.
9 Can you give me three ‘more common’ side effects of this medicine?
Any THREE:// i) constipation, diarrhoea// ii) feeling unusually tired or weak // iii) stomach or belly pain, feeling sick (nausea) // iv) headache// v) trouble sleeping
Note: Ask them to point out where is says 'more common side effects' when they answer
10 Imagine that you usually take your medicine at 8 o’clock in the evening. You realise at 3 o'clock in the afternoon that you have forgotten to take your medicine the night before. What does the leaflet say you should you do?
Leaflet says:// i) skip the dose and take your next dose when you’re meant to// ii) do not take a double dose.
Prompt: if they only say the first part ask them ‘Is there anything else it mentions?’
65
FINAL REPORT
11 Imagine you have been on this medicine for three months and you start to get muscle pain or weakness that you haven't had before. What does the leaflet say you should do?
Need ALL: // i) Call your doctor straight away // ii) go to the Accident and Emergency Department at your nearest hospital
12 Why may you need to be careful driving after using this medicine?
May make some people feel dizzy
If whole section read ask: “What might you experience that means you may not be able to drive?”
13 Haemorrhagic stroke.
What does the leaflet say may happen if you have ever had a haemorrhagic stroke and you are given this medicine?
May increase the risk of you having another stroke
14 How much grapefruit juice would you be able to drink each day when you are taking this medicine, before it could cause side effects?
Up to 1.2 litres
15 Clarithromycin Imagine you are currently taking Lipitor and your doctor prescribes you a new medicine called 'clarithromycin'. What does the leaflet say about how taking this medicine may act with Lipitor?
ANY: It may affect how it works OR how well it works OR it may interfere with it
Participants were also asked to provide feedback on the following aspects of the leaflet:
1. General impressions 2. Likes/dislikes 3. Appearance (columns, font) 4. Language 5. Size of print 6. How easy to find information 7. Improvements 8. Other comments
66
FINAL REPORT
Appendix 7. Comprehensive CMI Selected for Trial: Lipitor LIP-POR (I-CMI 1)
67
FINAL REPORT
68
FINAL REPORT
69
FINAL REPORT
Appendix 8. Comprehensive CMI Selected for Trial: Lipitor LIP-LAN (I-CMI 4)
70
FINAL REPORT
71
FINAL REPORT
72
FINAL REPORT
Appendix 9. Summary CMI Selected for Trial: Lipitor LIP-SUM (I-CMI 7)
73
FINAL REPORT
74
FINAL REPORT
Appendix 10. Comprehensive CMI Format Selected for Trial: Mersyndol MER-POR (I-CMI 2)
75
FINAL REPORT
76
FINAL REPORT
77
FINAL REPORT
Appendix 11. Summary CMI Format Selected for Trial: Mersyndol MER-SUM (I-CMI 5)
FINAL REPORT Appendix 12. Consumer Phone Survey - Initial 5-9 days
Telephone Survey Initial
Investigating Consumer Medicine Information Pilot Study Participant Details Patient Code: __/ __ __ / __ __ Participant Name: ____________________________________ Phone Number: ____________________________________ Medicine Name: ____________________________________ Leaflet (CMI) Format Number: ____________________________________ Section 1: General Counselling: 1. Was this the first time you have used/taken this medicine?
Yes ___ No __ If no, How long have you been taking it?_________________
2. Who handed out your Lipitor
® / Mersyndol
® tablets [delete as necessary] to you today?
Pharmacist / Pharmacy Graduate / Pharmacy Assistant / I don’t know 3. Did the pharmacist or any of the staff talk to you about your medicine?
Yes ___ No ____ (go to Q7)
4. Who talked to you about your medicine?
Pharmacist / Pharmacy Graduate / Pharmacy Assistant / I don’t know 5. About how long did the pharmacist or any of the other staff talk to you about your medicine?
Approx _______ minutes 6. What do you think about the amount of spoken medicine information the pharmacist gave you? Too long / Too short / Too much / Informative / Not informative / Other _____________ 7. Did you receive any written information about your Lipitor
® / Mersyndol
® [delete as necessary]?
Yes_____ No_____ (Cease Interview – incorrectly recruited/ misunderstood. F/Up with pharmacist)
8. How was the information given out to you? It was simply handed out / I was encouraged to read it / the pharmacist briefly reviewed it / the pharmacist spoke about it in detail /Other ______________________
9. What do you think about the amount of written medicine information the pharmacist gave you? Too long / Too short / Too much / Informative / Not informative / Other _____________
79
FINAL REPORT
Section 2: Use of leaflet: 1. Have you still got this leaflet?
Yes ___ No____ If no, then may I ask what you did with it? __________________________________________
2. Did you read any of this leaflet? Yes ____ If yes, then interviewer: “May I ask your reasons why you did?” ________________________ No ____ If no, then interviewer: “May I ask your reasons why? (Go to Section 3) __________________
3. Have you done anything different as a result of what you read in this leaflet?
Yes ____ If yes, what have you done? No ____
4. How often have you looked at/ referred to this leaflet? ___________ Section 3: Consumer Instrument Rating Form: After reading the medicine information you were given on Lipitor
® / Mersyndol
® [delete as necessary], could you
please give us your opinion about this leaflet by answering the following questions. 1. Overall, how easy or hard would you say the information in the medicine leaflet is to ………? Very easy Quite easy In between Quite hard Very hard Read � � � � � Understand � � � � � Remember � � � � � Locate important information � � � � � Keep for future reference � � � � � 2. If you were taking this medication for the first time and you found this medicine information in the medication box or received this leaflet from the pharmacist, how likely is it that you would (a, b, c)……… the medicine leaflet? Very likely Somewhat likely Unsure Somewhat unlikely Very unlikely (a) Read � � � � � (b) Use � � � � � (c) Keep � � � � � Section 3 - Information about medicines Please rate your overall feeling about the written information you have received for your medicine 3a. How much written information have you received about the following? None none too about too needed written little right much What your medicine is for � � � � � What it does � � � � � How it works � � � � � How long it will take to act � � � � � How you can tell if it is working � � � � � How long you will need to be on your medicine � � � � � How to use your medicine � � � � � Benefit of taking your medicine � � � � � Whether the medicine has any unwanted effects (side effects) � � � � � What are the risks of you getting side effects � � � � � What you should do if you experience unwanted side effects � � � � � Whether you can drink alcohol whilst taking this medicine � � � � �
80
FINAL REPORT
Whether this medicine interferes with other medicines � � � � � Whether the medicine will make you feel drowsy � � � � � How to look after your medicine � � � � � What you should do if you forget to take a dose � � � � � 3b. I am going to read out the same list of topics. Can you please tell me what you think about how useful you think this information would be if you were taking this medicine for the first time? How useful is the info? very fairly not so useful useful useful What your medicine is for � � � What it does � � � How it works � � � How long it will take to act � � � How you can tell if it is working � � � How long you will need to be on your medicine � � � How to use your medicine � � � Benefit of taking your medicine � � � Whether the medicine has any unwanted effects (side effects) � � � What are the risks of you getting side effects � � � What you should do if you experience unwanted side effects � � � Whether you can drink alcohol whilst taking this medicine � � � Whether this medicine interferes with other medicines � � � Whether the medication will make you feel drowsy � � � How to look after your medicine � � � What you should do if you forget to take a dose � � � 4. I am going to read out words describing the design, layout and tone of the medicine leaflet. On a scale of 1 - 5, which best describes your thoughts about the leaflet? 1 2 3 4 5
poorly organized well organized
1 2 3 4 5
unattractive attractive
1 2 3 4 5 poor print size ideal print size
1 2 3 4 5 alarming in tone encouraging in tone
1 2 3 4 5 unhelpful helpful
1 2 3 4 5 biased unbiased
1 2 3 4 5 poor spacing between lines ideal spacing between lines 5. Would you like to make any other comments about this particular medicine leaflet?
81
FINAL REPORT
___________________________________________________________________________________________ Section 4a: 8 - Item Medication Adherence Scale: (Morisky): (For Lipitor
® only)
Now, I am going to ask you a few questions about you taking your tablets. 1. Do you sometimes forget to take your Lipitor
® tablets? Yes / No
2. Over the past 2 weeks were there any days when you did not take you Lipitor
® tablets? Yes / No
3. Have you ever cut back or stopped taking your medicine without telling your doctor because you felt worse
when you took it? Yes / No 4. When you travel or leave home, do you sometimes forget to bring your medicine along? Yes / No 5. Did you take your Lipitor
® medicine yesterday? Yes / No
6. When you feel like your cholesterol is under control, do you sometimes stop taking your medicine? Yes /
No 7. Do you ever feel hassled about sticking to your cholesterol lowering treatment plan? Yes / No 8. How often do you have difficulty remembering to take your cholesterol medication? _______
Section 5: Health Information Understanding 1. How confident are you filling out forms by yourself? (“Confident with Forms”) Extremely Quite Somewhat A little Not at all � � � � � 2. How often do you have someone help you read written medicine information? (“Help Read”) None of the time A little of the time Some of the time Most of the time All of the time � � � � � 3. How often do you have problems learning about your medical condition or medicines because of difficulty reading written information? (“Problems Reading”) None of the time A little of the time Some of the time Most of the time All of the time � � � � � Thank you for participating in this study. Your time is greatly appreciated and your input is highly valued. Are there any comments relevant to CMIs or written drug information which you would like to make?
82
FINAL REPORT
Appendix 13. Consumer Phone Survey - 4 week follow-up
FOLLOW-UP TELEPHONE SURVEYS
Investigating Consumer Medicine Information Pilot Study
Participant Details Patient Code: __/ __ __ / __ __/___ Participant Name: ____________________________________ Phone Number: ____________________________________ Medicine Name: ____________________________________ Section 1: Use of leaflet: 1. Have you still got this leaflet?
Yes ___ If yes, why did you keep it? __________________________________________ No____ If no, then may I ask what you did with it? __________________________________________
2. Did you read any of this leaflet since we last spoke to you in the first survey?
Yes ____ If yes, then interviewer: “May I ask your reasons why you did?” ________(IF ANSWERED YES
– NEED TO COMPLETE SECTION 2) No ____ If no, then interviewer: “May I ask your reasons why? ______________________ (Go to Section 3 – LIPITOR
® ONLY OR FOR MERSYNDOL
® PROCEED TO SECTION 4)
3. Have you done anything different as a result of what you read in this leaflet?
Yes ____ If yes, what have you done? No ____
4. How often have you looked at or referred to this leaflet since we last spoke to you? ___________ Section 2: Consumer Instrument Rating Form: (ONLY ASK THIS SECTION IF THEY ANSWERED YES SECTION 1, QUESTION 2) After reading the medicine information you were given on Lipitor
® / Mersyndol
® [delete as necessary], could you
please give us your opinion about this leaflet by answering the following questions. 1. Overall, how easy or hard would you say the information in the medicine leaflet is to ………? Very easy Quite easy In between Quite hard Very hard Read � � � � � Understand � � � � � Remember � � � � � Locate important information � � � � � Keep for future reference � � � � �
83
FINAL REPORT
2. If you were taking this medication for the first time and you found this medicine information in the medication box or received this leaflet from the pharmacist, how likely is it that you would (a, b, c)……… the medicine leaflet? Very likely Somewhat likely Unsure Somewhat unlikely Very unlikely (a) Read � � � � � (b) Use � � � � � (c) Keep � � � � � Information about medicines Please rate your overall feeling about the written information you have received for your medicine 3a. How much written information have you received about the following? None none too about too needed written little right much What your medicine is for � � � � � What it does � � � � � How it works � � � � � How long it will take to act � � � � � How you can tell if it is working � � � � � How long you will need to be on your medicine � � � � � How to use your medicine � � � � � Benefit of taking your medicine � � � � � Whether the medicine has any unwanted effects (side effects) � � � � � What are the risks of you getting side effects � � � � � What you should do if you experience unwanted side effects � � � � � Whether you can drink alcohol whilst taking this medicine � � � � � Whether this medicine interferes with other medicines � � � � � Whether the medicine will make you feel drowsy � � � � � How to look after your medicine � � � � � What you should do if you forget to take a dose � � � � � 3b. I am going to read out the same list of topics. Can you please tell me what you think about how useful you think this information would be if you were taking this medicine for the first time? How useful is the info? very fairly not so useful useful useful What your medicine is for � � � What it does � � � How it works � � � How long it will take to act � � � How you can tell if it is working � � � How long you will need to be on your medicine � � � How to use your medicine � � � Benefit of taking your medicine � � � Whether the medicine has any unwanted effects (side effects) � � � What are the risks of you getting side effects � � � What you should do if you experience unwanted side effects � � � Whether you can drink alcohol whilst taking this medicine � � � Whether this medicine interferes with other medicines � � � Whether the medication will make you feel drowsy � � � How to look after your medicine � � � What you should do if you forget to take a dose � � �
84
FINAL REPORT
4. Would you like to make any other comments about this particular medicine leaflet? ___________________________________________________________________________________________ Section 3: 8 - Item Medication Adherence Scale: (Morisky): (For Lipitor
® only)
Now, I am going to ask you a few questions about you taking your tablets. 1. Do you sometimes forget to take your Lipitor
® tablets? Yes / No
2. Over the past 2 weeks were there any days when you did not take you Lipitor
® tablets? Yes / No
3. Have you ever cut back or stopped taking your medicine without telling your doctor because you felt worse
when you took it? Yes / No 4. When you travel or leave home, do you sometimes forget to bring your medicine along? Yes / No 5. Did you take your Lipitor
® medicine yesterday? Yes / No
6. When you feel like your cholesterol is under control, do you sometimes stop taking your medicine? Yes /
No 7. Do you ever feel hassled about sticking to your cholesterol lowering treatment plan? Yes / No 8. How often do you have difficulty remembering to take your cholesterol medication? _______
Section 4: Health Information Understanding 1. How confident are you filling out forms by yourself? (“Confident with Forms”) Extremely Quite Somewhat A little Not at all � � � � � 2. How often do you have someone help you read written medicine information? (“Help Read”) None of the time A little of the time Some of the time Most of the time All of the time � � � � � 3. How often do you have problems learning about your medical condition or medicines because of difficulty reading written information? (“Problems Reading”) None of the time A little of the time Some of the time Most of the time All of the time � � � � � Thank you for participating in this study. Your time is greatly appreciated and your input is highly valued. Are there any comments relevant to CMIs or written drug information which you would like to make?
85
FINAL REPORT
Appendix 14. Consumer Demographics for the CMI Trial
1. Sex: Male �
Female � 2. Date of Birth: _ _ / _ _ / _ _ _ _ 3. Country of birth: Australia � Overseas � please state ______________________ 4. Main language spoken at home: English � Other � please state ______________________ 5. Highest level of education: None � Primary school �
School Certificate (Year 10) � Higher School Certificate (Year 12) � Tertiary (Diploma, Bachelor or higher) � 6. Occupation: Managers and administrators � Professionals and associate professionals � Tradespersons and related workers � Clerical workers � go to Q 7 Production and transport workers � Sales and service workers � Labourers and related workers � Homemaker � go to Q 8 Student � go to Q 8 Other (please specify)________________ � go to Q 7 7. Employment status: Full time � Part time � Retired � Unable to work due to health reasons � Unemployed � 8. How long have you been taking Lipitor
® ?_______________________
9. What is the strength and dose of your Lipitor
® ?
Strength __________________________ Dose ____________________ 10. Have you ever received Consumer Medicine Information (CMI) for Lipitor
® in the past?
Yes � ………………… How long ago? __________________ No � 11. What are your current medical conditions? ______________________________________________________________________________________________________________________________________________________________________________________ 12. What are your current medications as prescribed by your doctor? ______________________________________________________________________________________________________________________________________________________________________________________
Consumer Survey - Lipitor
86
FINAL REPORT
1. Sex: Male � Female �
2. Date of Birth: _ _ / _ _ / _ _ _ _ 3. Country of birth: Australia � Overseas � please state ______________________ 4. Main language spoken at home: English � Other � please state ______________________ 5. Highest level of education: None � Primary school �
School Certificate (Year 10) � Higher School Certificate (Year 12) � Tertiary (Diploma, Bachelor or higher) � 6. Occupation: Managers and administrators � Professionals and associate professionals � Tradespersons and related workers � Clerical workers � go to Q 7 Production and transport workers � Sales and service workers � Labourers and related workers � Homemaker � go to Q 8 Student � go to Q 8 Other (please specify)________________ � go to Q 7 7. Employment status: Full time � Part time � Retired � Unable to work due to health reasons � Unemployed � 8. How long have you been taking Mersyndol
® ?_______________________
9. What is the dose of your Mersyndol® ?
Dose ____________________ 10. Have you ever received Consumer Medicine Information (CMI) for Mersyndol
® in the past?
Yes � ………………… How long ago? __________________ No � 11. What are your current medical conditions? ______________________________________________________________________________________________ ________________________________________________________________________________________ 12. What are your current medications as prescribed by your doctor? ______________________________________________________________________________________________________________________________________________________________________________________
Consumer Survey - Mersyndol
87
FINAL REPORT
Appendix 15. Pharmacist Surveys for the CMI Trial
Pharmacist Survey - Lipitor®
Survey Questions: 1. Was this the first time the customer has used/taken this medicine? Yes o No o If no, how long have they been taking it?_________________ 2. Who handed out the customer’s Lipitor
® tablets to them today?
Pharmacist o Pharmacy Intern o Pharmacy Assistant o I don’t know o 3. Did you or any of the staff talk to them about their medicine? Yes o No o(go to Q7) 4. Who talked to them about their medicine? Pharmacist o Pharmacy Intern o Pharmacy Assistant o I don’t know o 5. About how long did you or any of the other staff talk to them about their medicine? Approx _______ minutes 6. What do you think about the amount of verbal medicine information that you gave them?
Too long o Too short o Too much oInformative o Not informative oOther______
7. Did you give them any written information about their Lipitor® ?
Yes o No o (Participant not eligible for study- stop completing survey) 8. How was the written information given out to them? Simply handed out o They were encouraged to read it o I briefly reviewed it o I spoke about it in detail o
9. What do you think about the amount of written medicine information that you gave them?
Too long o Too short o Too much oInformative o Not informative oOther_____ 10. There are six main sections in this type of leaflet; I would like to know if you went through each section either
in detail or briefly:
What the medicine is for In Detail o Briefly o Things to do before you take it In Detail o Briefly o How and When to take it In Detail o Briefly o Side Effects In Detail o Briefly o How to store your medicine In Detail o Briefly o Further Information In Detail o Briefly o
Study Details:
Patient Code: __/ __ __ / __ __ Participant Name: ______________
Pharmacist Name: ____________ Pharmacy Name:
88
FINAL REPORT
Pharmacist Survey - Mersyndol®
Survey Questions: 1. Was this the first time the customer has used/taken this medicine? Yes o No o If no, how long have they been taking it?_________________ 2. Who handed out the customer’s Mersyndol
® tablets to them today?
Pharmacist o Pharmacy Intern o Pharmacy Assistant o I don’t know o 3. Did you or any of the staff talk to them about their medicine? Yes o No o(go to Q7) 4. Who talked to them about their medicine? Pharmacist o Pharmacy Intern o Pharmacy Assistant o I don’t know o 5. About how long did you or any of the other staff talk to them about their medicine? Approx _______ minutes 6. What do you think about the amount of verbal medicine information that you gave them?
Too long o Too short o Too much oInformative o Not informative oOther______
7. Did you give them any written information about their Mersyndol® ?
Yes o No o (Participant not eligible for study- stop completing survey) 8. How was the written information given out to them? Simply handed out o They were encouraged to read it o I briefly reviewed it o I spoke about it in detail o
9. What do you think about the amount of written medicine information that you gave them?
Too long o Too short o Too much oInformative o Not informative oOther_____ 10. There are six main sections in this type of leaflet; I would like to know if you went through each section either
in detail or briefly:
What the medicine is for In Detail o Briefly o Things to do before you take it In Detail o Briefly o How and When to take it In Detail o Briefly o Side Effects In Detail o Briefly o How to store your medicine In Detail o Briefly o Further Information In Detail o Briefly o
Study Details:
Patient Code: __/ __ __ / __ __ Participant Name: ______________
Pharmacist Name: ____________ Pharmacy Name:
FINAL REPORT Appendix 16. Locator Success and Average Locator Times Per Question for each CMI (Lipitor
®)
Question Number
CMI Version (Alt CMI number), Type & UTQ Appendix No.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Totals
Original (17) Full UTQ App. 2
Avg /Q (min)
0.16 0.31 2 1.19 1.36 3.56 0.52 0.36 0.4 0.41 2.16 1 0.33 1.06 4.51
Difficulty 0 0 2 2 4 1 0 0 0 0 3 1 0 1 1 15
Not Found 0 0 1 0 0 4 0 0 0 0 0 0 0 1 3 9
Rewritten (18) Full UTQ App. 3
Avg /Q (min)
0.12 0.15 0.28 1.17 0.15 1.07 0.16 0.36 0.23 0.28 0.28 0.06 0.35 0.06 0.27
Difficulty 0 0 0 2 0 0 0 1 0 0 0 0 0 0 0 3
Not Found 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1
RED3 (10) Full UTQ App. 4
Avg /Q (min)
0.43 0.49 1.33 0.58 1.49 2.01 0.29 1.02 0.21 0.31 0.3 0.35 0.4 0.21 2.36
Difficulty 1 1 4 1 3 4 0 2 0 0 0 0 0 0 2 18
Not Found 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1
I-CMI 1 (3) Full UTQ App. 5
Avg /Q (min) 0.17 0.31 1.01 0.41 0.16 1.13 0.26 0.59 0.11 1.13 1.07 0.1 0.34 0.08 0.59
Difficulty 0 0 0 0 0 2 0 2 0 2 2 0 0 0 1 9
Not Found 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1
I-CMI 3 (5) Full UTQ App. 6
Avg /Q (min)
0.18 0.31 0.37 0.5 0.12 0.36 0.22 0.42 0.36 0.37 0.58 0.16 0.49 0.06 0.23
Difficulty 0 0 0 1 0 0 0 1 0 0 1 0 0 0 0 3
Not Found 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1
I-CMI 4 (7) Full UTQ App. 5
Avg /Q (min)
0.15 0.26 0.42 1.15 0.17 0.34 0.59 0.58 0.32 0.41 1.09 0.48 0.44 0.12 0.38
Difficulty 0 0 0 1 0 0 1 1 0 1 0 1 0 0 0 5
Not Found 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1
I-CMI 6 (16) Summary UTQ App. 7
Avg /Q (min)
0.14 0.09 0.29 0.54 0.04 0.4 0.09 0.45 0.15 0.13 0.24 0.04 0.12 0.05 0.14
Difficulty 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 2
Not Found 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
I-CMI 7 (19) Summary UTQ App. 8
Avg /Q (min)
0.11 0.11 0.18 0.27 0.11 0.29 0.07 0.05 0.09 0.06 0.07 0.07 0.1 0.04 0.06
Difficulty 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Found 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
90
FINAL REPORT Appendix 17. Locator Success and Average Locator Times Per Question for each CMI (Mersyndol
®)
Question Number CMI Version (Alt CMI number), Medicine, Type & UTQ Appendix No.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Totals
Original (17) Full UTQ App. 9
Avg /Q (min)
0.17 0.15 1.09 0.46 0.28 0.58 0.52 0.55 1.23 0.24 0.27 0.35 0.3 0.26 1.27
Difficulty 0 0 3 0 1 1 1 1 2 0 0 0 1 0 2 12
Not Found 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Rewritten (18) Full UTQ App. 10
Avg /Q (min)
0.15 0.24 0.5 0.16 0.58 0.16 0.32 0.33 0.18 0.19 0.24 0.17 0.16 0.22 0.56
Difficulty 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1
Not Found 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1
I-CMI 2 (3B) Full UTQ App. 11
Avg /Q (min)
0.11 0.14 1.07 0.11 0.27 0.14 0.29 0.2 0.1 0.36 0.07 0.08 0.05 0.14 0.27
Difficulty 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1
Not Found 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
I-CMI 5 (13) Summary UTQ App. 12
Avg /Q (min)
0.15 0.15 0.37 0.07 0.51 0.08 0.28 0.07 0.08 0.16 0.14 0.15 0.06 0.3 0.15
Difficulty 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1
Not Found 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Indicates number of people with difficulty (D) or who did not find the information (NF)
91
FINAL REPORT Appendix 18. Locator times and reading times per CMI (Lipitor
®)
Alternate CMI format number
CMI Version For User Testing
Wording & Type Overall Avg Time to complete each Q (min)
Median Time per Q (min)
Min / Max Time per Q
(min)
Avg Read Time (min)
Median Read Time (min)
Min / Max Time (min)
17 CMI Original
(Full) 1.23 1.21 0.32/ 2.36 10. 8 5 / 17
18 CMI Original (I-CMI)
Re-written (Full)
0.31 0.31 0.08 / 0.50 11 11 5 / 15
10
RED 3 RED3 1.07 1.01 0.39 /1.50 11 9 8 / 17
3 I-CMI 1 Re-written (Full)
0.46 0.44 0.17 / 1.31 9 10 4 / 13
5 I-CMI 3 Re-written (Full)
0.32 0.34 0.12 / 0.57 9 8 6 / 16
7 I-CMI 4 Re-written (Full)
0.41 0.39 0.19 / 1.13 10 9 7 / 15
16 I-CMI 6 Re-written (Summary)
0.22 0.22 0.12 / 0.34 6 6 4 / 11
19 I-CMI 7 Re-written (Summary)
0.13 0.12 0.04 / 0.24 4 4 3 / 4
Note: Column 1: Alternative CMI format number - relates to the draft CMI produced in the design and development stage (Step 4). Column 2: CMI Version - the format that was selected for user testing. Column 3: Wording & Type- this refers to the information content of the CMI. See full details of this in Step 4 Design and Development. Columns 4, 5 and 6: Refer to the average, median, and minimum and maximum times per question, overall, for the 15 questions in the UTQ. Columns 7, 8 and 9: Refer to the average, median, and minimum and maximum times taken by consumers to read the CMI.
92
FINAL REPORT
Appendix 19. Locator times and reading times per CMI (Mersyndol®)
Alternate CMI format number
CMI Version For User Testing
Wording & Type Overall Avg Time to complete each Q (min)
Median Time per Q (min)
Min / Max Time per Q
(min)
Avg Read Time (min)
Median Read Time (min)
Min / Max Time (min)
17 CMI Original
(Full) 0.44 0.39 0.17 / 1.44 8 9 5 / 11
18 CMI Original (I-CMI)
Re-written (Full)
0.28 0.21 0.09 / 1.27 9 9 7 / 15
3b I-CMI 2 Re-written (Full)
0.20 0.23 0.07 / 0.38 10 9 5 / 18
13 I-CMI 5 Re-written (Summary)
0.20 0.21 0.10 / 0.28 6 5 4 / 9
Note: Column 1: Alternative CMI format number - relates to the draft CMI produced in the design and development stage (Step 4). Column 2: CMI Version - the format that was selected for user testing. Column 3: Wording & Type- this refers to the information content of the CMI. See full details of this in Step 4 Design and Development. Columns 4, 5 and 6: Refer to the average, median, and minimum and maximum times per question, overall, for the 15 questions in the UTQ. Columns 7, 8 and 9: Refer to the average, median, and minimum and maximum times taken by consumers to read the CMI.
93
FINAL REPORT Appendix 20. Overview of Research Findings for CMI
1. Design and Formatting Findings
LAYOUT Headings As headings assist readers to search text, they need to be visually distinct or different. Therefore clear headings and sub-headings should be introduced, where necessary, using bold and differing font sizes depending on their tier.
• Tier 2 headings to be reverse tiered with black background and
white writing e.g. How to take Lipitor
• Tier 3 headings to be in bold and 1 point font size above that of the text
• Tier 4 headings to be in bold but remain the same size font as that of the body of the text
New Sub-headings New sub-headings should be included, for the organisation of ‘like’ information. The new sub-headings may include: Pregnancy and Breastfeeding; Food and Drink; Driving and Using Machines or others as necessary based on the individual CMI. These sub-headings would incorporate related information in order to increase localization times and comprehension. This may allow users to locate information more rapidly. The re-organisation of information also allows people to ‘self-tailor’ the information, skipping over sections that do not apply to them i.e. Pregnancy and Breastfeeding if they were male.
Bullet Points The use of bullet points to organise lists of information assist with better processing of information by the user.
Columns Two column format was most preferred in testing.
Emphasis The use of bold should be minimised in the text and used for tier 3 and 4 headings, and for what is considered ‘more’ important information where emphasis of a point is deemed to be suitable. Overuse of both bold headings and a significant number of bolded sentences in the main text has the effect of reducing the impact and text recall of bolded information. Bolding should be reserved for headings and only the most important pieces of main text. The decision of what is deemed important information should be based on both clinical content and the safety implications using a number of evidence-based clinical resources eg MIMS on line, the medicines’ Product Information, Australian Medicines Handbook 2009 and Micromedex.
Pictures and Graphics
Consumers and HCPs expressed a preference for the use of pictures and graphics. The use of these was not introduced in the course of the project due to the print capacity limitations within pharmacies. However the logos of both Pfizer and Sanofi Aventis were used on the CMI as well as a standardised logo. Test participants felt this made the document look more ‘official’.
Navigation Aids Where to find information in this leaflet
1. What ‘Medicine’ is used for 2. Before you take ‘Medicine’ 3. How to take ‘Medicine’ 4. While you are taking ‘Medicine’ 5. Side effects 6. Product details
Table of contents provides an anchoring point for the first section. The numbering corresponds to the relevant section of the leaflet, and should be incorporated to aid in users finding information topics of interest quickly. The colour of the numbers was the same in the list as well as the sections in the CMI.
94
FINAL REPORT LENGTH Line Length Short lines are preferred however the 3 column style sentence may be
considered too short and ‘newspaper-like’.
Line Spacing Particular attention should be given to the structure of sentences and paragraphs and how they ‘hang’ together under a heading or bullet point to improve visual organization and readability. Orphan sentences that cross over to the next page reduce readability and localisation of information.
Document Length The document length should be kept to a minimum where possible.
TYPE Font Sans Serif was most preferred e.g. Frutiger or Myriad Roman Bold or Semi-Bold.
Font Size Minimum 10 point font size.
Colour The use of colour was suggested by many participants however print limitations within pharmacies did not allow for exploration within this project.
2. Wording and Linguistic Changes – See also CORE CMI Example and Specific Linguistic Recommendations by Alison Moore
GENERAL LANGUAGE
Word Choice The use of ‘plain English’, The theory behind ‘plain English’ writing is that the ‘intended audience can read, understand and act upon the first time they read it’. Incorporating this with good document design principles and layout, should produce medicine information that people can rely on when they make decisions or need to act upon an adverse event when using their medicine.
Repetition Repetition throughout the document was removed through the re-organisation of information with the addition of sub-headings.
Jargon The removal of jargon or technical terms where possible is necessary in order to provide clear and concise information.
Phrasing ‘Lipitor’ replaced ‘LIPITOR’ in capitals, as capitals placed an overemphasis on the brand name of the medicine. It also goes against good writing principles as recommended previously by Sless
32. Words in
capitals are harder to read than those in lower case, because the shape of words helps the brain to quickly recognise words. Words in capitals have less 'shape' and hence are less quickly recognised. This problem is magnified in CMI such as this, where the name of the product is repeated frequently.
Important Contact Information
The inclusion of important contact information and website address for more information was based on focus groups and the desire by consumers and health care professionals to be directed to a legitimate site that contained the CMI. The location of this information should be located within the text prior to the table of contents.
Important Contact Information for your Medicine:
• Emergency: 000
• Australian Poisons Information Centre: 13 11 26
• NPS Medicines Line: 1300 888 763
• Pharmaceutical Company: 1800 000 000
95
FINAL REPORT 3. Consumer review and input Consumers and Representative Groups
Consultation prior to and during CMI development should involve consumer input through either individuals with first hand experience of the disease state being treated, an expert in the area or with representatives from a disease specific consumer group. A formal process could be introduced seeking specific feedback on needs and opinions.
4. User Testing
Inclusion Criteria In order to ensure that participants are representative of the general population of likely users of the medicine being tested each round of ten should consist of a sampling of:
• Age: minimum of one person in each decade between 30 and 70-plus (Lipitor
®) and 20 and 70-plus (Mersyndol
®)
• Gender: minimum 3 participants of each gender • Education: no more than 3 higher education graduates (based on
ABS statistics59
) • Literature use: at least 2 participants who either do not use written
documents as part of their work, or who are currently not working or retired
• Non-English speaking: where possible a one participant whose first language is not English
It would be ideal if a basic health literacy questionnaire could be completed prior to User Testing to determine the impact of overall health literacy on testing results.
User testing Questions
The first stage in the development of the user testing questionnaires (UTQ) involves determining the key information that is important for the safe and effective use of the medicine by consumers, and which related specifically to safety, urgent actions or referral, dose, use, precautions, interactions or contraindications for the medicine. This involves reference to various clinical medicine information sources such as Micromedex, the Australian Medicines Handbook and the medicine’s Product Information. Ideally a registered pharmacists should review the key points identified.
The questions in the UTQ should focus on these key points or messages. The purpose of the questions is to mimic real life situations and reflect possible questions or concerns that an actual user may have. The questions themselves should focuse on three main areas:
• Facts e.g. Dose; what the medicine is for? • Actions required e.g. what action would you take if you missed a
dose? • Explanations of action or outcome e.g. Why can’t you drive while
taking this medicine? The questions should be chosen from information in each of the main sections, to give appropriate coverage. The fifteen questions produced should be reviewed by at least one other appropriate person and then pilot tested on two participants.
User Testing Two rounds of 10 subjects to be tested and CMI scored as per the criteria in the Usability Guidelines. Results should be fed back in an iterative and formative process to determine the strengths and weaknesses of the document itself. This process will determine whether and where the document requires rewriting or reformatting. An internal quality control mechanism should ensure consistency and veracity of testing.
5. Review by independent committee
Independent committee including all key stakeholders (eg consumers, healthcare professionals, QARG, pharmaceutical manufacturers,)
A set of standard protocols (incorporating Usability Guidelines and changes to the Guidelines as a result of the project’s findings) should be developed to inform a minimum standard of CMI produced by Pharmaceutical Manufacturers. An independent body should oversee and maintain these quality standards.
96
FINAL REPORT Appendix 21. Example of Standard Text for Core CMI (Cholesterol Medication)
[BRAND NAME] Drug Name
Consumer Medicine Information
This leaflet provides important information for
people taking [Medicine] or who are about to start
taking it.
You may have discussed many of these points with
your doctor already. However, it is important to
read this leaflet about [Medicine] to:
• double check that it is safe for you to take
• check exactly how to take it
• know what to expect if you have any side effects,
and what to do
• know in advance where to find important
information in the leaflet.
This is not all the information that is available on
[Medicine]. If you have any concerns about taking
this medicine, speak to your doctor or
pharmacist. More information is also available at:
www.medicines.org.au
Keep this leaflet with your medicine. You may want
to read it again.
Important Contact Information for your Medicine
• Emergency: 000
• Australian Poisons Information Centre: 13 11 26
• NPS Medicines Line: 1300 888 763
• Drug Company: 1800 000 000
• Websites: www.medicines.org.au
Where to find information in this leaflet
7. What [Medicine] is used for
8. Before you take [Medicine]
9. How to take [Medicine]
10. While taking [Medicine]
11. Side effects
12. Product details
1. What [Medicine] is used for
[Medicine] contains a medicine called [Drug name].
This belongs to a group of medicines called [group].
[Medicine] is used to lower the amount of fats in
your blood. These fats include cholesterol and
triglycerides.
[Medicine] is used in people with high cholesterol
who:
• have high blood pressure and coronary heart
disease (CHD)
or
• are at risk of CHD. This includes people with
diabetes, people who have had a stroke or have
arrowing of the blood vessels in the arms or legs.
In these people, [Medicine] is used to help reduce
the risk of having a heart attack or stroke.
When you are taking [Medicine], you should also
do things like:
• follow a low fat diet
• exercise
• maintain a healthy weight
• stop smoking.
What is cholesterol? Everyone has cholesterol in their blood. It is a type of
fat needed by the body. However, too much can be
a problem.
Cholesterol is found in many foods and is also made
in your body by the liver. Your level can become too
high if:
• your body makes too much cholesterol or
• you eat too much fat in your diet.
High cholesterol is more likely with certain illnesses
or if you have a family history of high cholesterol.
There are different types of cholesterol.
• HDL cholesterol is the 'good' cholesterol that
may remove the bad cholesterol from the blood.
• LDL cholesterol is the 'bad' cholesterol that can
block your blood vessels.
The blocking of your blood vessels can cause several
types of blood vessel disease, heart attack, angina
and stroke.
Triglycerides are another type of fat, which are a
source of energy. High levels of triglyceride can be
linked with a low level of 'good' cholesterol. This
may increase your risk of heart disease.
Some patients have both high cholesterol and high
triglycerides. [Medicine] can be used to treat both.
97
FINAL REPORT
How [Medicine] works [Medicine] works by reducing the amount of
cholesterol made by the liver. It:
• lowers the ‘bad’ cholesterol
• raises the ‘good’ cholesterol.
In most people, there are no signs of high
cholesterol or triglycerides. However, your doctor
can measure your levels with a simple blood test.
You may have been prescribed [Medicine] for
another reason. Speak to your doctor if you have
any questions about why you are taking [Medicine].
2. Before you take [Medicine]
Do not take [Medicine] if:
• you have an allergy to [Medicine] or any of the
ingredients listed at the end of this leaflet. Signs
of an allergic reaction may include skin rash,
itching, difficulty breathing, or swelling of the
face
• you are intolerant to [specific ingredient]
• you have [Disease]
• you are pregnant, might become pregnant, or
are breast-feeding (see ‘Pregnancy and Breast-
feeding’ below).
If any of the above applies to you, do not start taking
[Medicine] until you check with your doctor.
Check with your doctor before you start
taking [Medicine] if:
• you have [ medical condition]
• you have [ medical condition]
• you have allergies to any other medicines or
anything else, such as foods, preservatives or
dyes.
If you have not already told your doctor about any
of the above, check back with them before taking
[Medicine].
Taking other medicines Tell your doctor before you start taking [Medicine] if
you are taking any other medicines, vitamins or
remedies. This includes medicines that you buy
without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with [Medicine].
These include:
• medicine – for [general disease]
• medicine – for [general disease]
• medicine – for [general disease]
These medicines may be affected by [Medicine], or
may affect how well it works. Your doctor or
pharmacist has more information on medicines that
affect [Medicine].
Pregnancy and breast- feeding You should use a reliable method of birth control if
you are a woman of childbearing age. This is
because [Medicine] may affect your unborn baby if
you take it during pregnancy.
If you become pregnant while you are taking
[Medicine], stop taking it and talk to your doctor
immediately.
Do not take the medicine if you are breast-feeding
or intend to breast-feed. This is because [Medicine]
may pass into breast milk and affect your baby.
3. How to take [Medicine]
Take [Medicine] only when prescribed by your
doctor.
How much to take • The usual dose is [X] mg taken [frequency] a day.
• Swallow with a glass of water or other liquid.
• You can take [Medicine] with or without food.
If you are not sure how to take it, ask your doctor or
pharmacist for help. Also, talk to your doctor or
pharmacist if the directions they give you are
different from the information in this leaflet.
When to take it You can take [Medicine] at [specify] time of the day.
When you decide on a time, try to keep taking it at
the same time each day.
• Taking your tablets at the same time each day
will have the best effect.
• It will also help you remember when to take the
tablets.
How long to take it [Medicine] helps to lower your cholesterol, but is not
a cure for it. It is possible you may have to take
cholesterol medicines for the rest of your life to keep
your cholesterol at a healthy level.
If you forget to take it • If it is almost time for your next dose, skip the
dose you missed. Take your next dose when you
are meant to.
• Do not take a double dose to make up for the
dose that you missed.
• Otherwise, take it as soon as you remember.
Then, go back to taking your tablets as normal.
• If you are not sure whether to skip the dose, call
your doctor or pharmacist for advice.
98
FINAL REPORT If you have trouble remembering to take your
tablets, ask your doctor or pharmacist for some
hints.
If you take too much (overdose) If you think you or anyone else may have taken too
much [Medicine], you may need urgent medical
attention.
You should immediately:
• Phone the Australian Poisons Information
Centre (telephone 13 11 26)
or
• go to the Accident and Emergency department
at your nearest hospital.
Do this even if there are no signs of illness or
poisoning.
You may want to keep this telephone number
handy.
4. While you are taking {Medicine]
Things you should do:
• If you are about to start on a new medicine, let
your doctor or pharmacist know that you are
taking [Medicine].
Things you should not do:
• Do not give [Medicine] to anyone else, even if
they have the same problem as you.
• Do not use [Medicine] to treat any other illnesses
unless your doctor tells you to.
Food and drink Alcohol
• Drinking large amounts of alcohol may increase
your chance of [Medicine] causing liver
problems.
• If you drink alcohol regularly speak with your
doctor about taking [Medicine].
Grapefruit juice
• Grapefruit juice makes the body break down
[Medicine] more slowly.
• If you drink large amounts of grapefruit juice
(more than 1.2 litres) each day, your chance of
getting side effects from [Medicine] may
increase.
Driving or using machines
[Medicine] generally does not affect you being able
to drive a car, or use machines or tools. However,
[Medicine] may make some people feel dizzy.
Be careful driving or using machines or tools until
you know how [Medicine] affects you.
Looking after your medicine • Keep your tablets in the blister pack until it is
time to take them.
• Do not start a new packet if the packaging is
torn or shows signs of being opened.
• Do not take the tablets after the expiry date
(EXP) on the pack has passed.
• Keep [Medicine] in a [Insert correct storage
conditions]
• Keep your tablets where young children
cannot reach them.
• If your doctor tells you to stop taking [Medicine],
or the tablets have passed their expiry date, take
them to your pharmacy for disposal.
5. Side effects
All medicines can have side effects. Ask your doctor
or pharmacist to answer any questions you may
have about side effects.
Call your doctor straight away or go to the
Accident and Emergency Department at your
nearest hospital if you notice any of the
following rare but serious side effects:
• [side effect]
• [side effect]
• [side effect]
• [side effect]
• [side effect]
These serious side effects are rare.
Speak with your doctor if you notice any of the
following more common side effects and they
worry you:
• [side effect]
• [side effect]
• [side effect]
• [side effect]
• [side effect]
• [side effect]
• [side effect]
Usually these effects are mild and do not last long.
Tell your doctor if you notice anything else that is
making you feel unwell.
99
FINAL REPORT • Occasionally, some people experience side
effects not listed above.
• Some people have no side effects while taking
[Medicine].
6. Product details What [Medicine] tablets contain The active ingredient of [Medicine] is [Drug].
The inactive ingredients are: [INGREDIENTS]
Product description [Medicine] tablets are [DESCRIPTION OF EACH STRENGTH]
Distributor [Medicine] is supplied in Australia by:
Medicine Company Pty Ltd
ABN XXXXXXXX
Address 1
City, State, Postcode
Country
Toll Free Number: 1800 000 000 ®Registered Trademark
Australian Registration Number 10mg AUST R XXXX
20mg AUST R XXXX
40mg AUST R XXXX
80mg AUST R XXXX
This leaflet has been prepared for research purposes only and is the
property of the Commonwealth.
FINAL REPORT Appendix 22. Consumer Rankings for each CMI regarding Quantity and Usefulness of Information
Rankings for Quantity of Information Rankings for Usefulness of Information
Information Content
LIP-AUS
LIP-POR
LIP-LAN
LIP-SUM
MERAUS
MERPOR
MER SUM
LIP-AUS
LIP-POR
LIP-LAN
LIP-SUM
MERAUS
MERPOR
MER SUM
What your medicine is for
3 1 2 4 2 1 3 3 4 1 2 2 3 1
What it does 3 1 2 4 2 1 3 3 4 1 2 2 3 1
How it works 3 1 2 4 2 3 1 3 3 1 2 2 3 1
How long it will take to act
1 2 3 3 2 1 3 3 4 1 2 2 3 1
How you can tell if it is working
2 1 3 1 3 2 1 3 4 2 1 2 3 1
How long you will need to be on the medicine
2 1 3 4 2 1 3 3 4 1 2 2 3 1
How to use the medicine
3 1 2 4 1 2 3 3 4 1 2 2 3 1
Benefit of taking your medicine
2 1 3 4 3 1 2 3 4 1 2 2 3 1
Whether the medicine has any unwanted effects
4 3 1 2 1 3 2 2 4 1 2 1 3 2
What are the risks of you getting side effects
4 3 1 2 1 2 3 3 4 1 2 1 2 3
What should you do if you get a side effect
4 2 2 1 1 3 2 4 2 1 2 2 3 1
Whether you can drink alcohol whilst on the medicine
2 1 3 4 2 1 3 4 2 3 1 3 2 1
Whether this medicine interferes with other medicines
3 1 2 4 1 2 3 3 4 1 2 1 3 2
Whether this medicine will make you drowsy
3 1 2 4 1 3 2 2 4 1 2 2 3 1
How to look after your medicine
2 1 3 4 2 1 3 3 4 2 1 2 3 1
What you should do if you forget to take a dose
2 1 3 4 2 1 3 2 4 1 2 2 3 1
FINAL REPORT
Appendix 23. Overcoming barriers in my pharmacy
Barriers In my pharmacy... If no, what will I do to address this barrier?
CMI ...I have access to CMIs online or in hard copy � Yes � No
...I have space to store hard copies of CMIs or reference material
� Yes � No
...I have a printer dedicated to printing CMI � Yes � No
Cost ...I have calculated the cost of printing CMI � Yes � No
...I am able to cover the cost of printing CMI � Yes � No
...I have calculated the staff cost of providing CMI
� Yes � No
...I am able to cover the staff cost of providing CMI
� Yes � No
Consumer/ Patient
...I have developed a CMI awareness campaign (posters etc) for my pharmacy
� Yes � No
...I have developed a protocol to counsel patients that will clearly outline the important aspects of taking their medicine and actions to be taken when problems arise
� Yes � No
Pharmacist ...I understand the importance of CMI � Yes � No
...I know how to use CMI when counselling patients
� Yes � No
...I have established a workflow that will allow me time to counsel patients
� Yes � No
Pharmacy ...patients are aware they can approach me for advice as they require
� Yes � No
...I have a dedicated consultation area to use for counselling
� Yes � No
FINAL REPORT
Appendix 24. Enabling facilitators in my pharmacy
Facilitators In my pharmacy... If no, what will I do to enable this facilitator?
Increased demand by consumers
... I have developed a CMI awareness campaign (posters etc) for my pharmacy
� Yes � No
Pharmacist counselling skills
...I have undertaken training in counselling and communication skills to improve my ability to counsel patients
� Yes � No
Relationship with Doctors
...I have contacted my local doctors to ensure they understand the benefit of CMI and established their support for my role as a medicine information provider
� Yes � No
Pharmacy layout ... I have a dedicated consultation area to use for counselling
� Yes � No
Patient expectation
...I have made patients aware I am available to counsel through awareness campaigns and making myself available as required
� Yes � No
Manpower/ staff ... I have established a workflow that will allow me time to counsel patients
� Yes � No
Communication/ teamwork
...I have developed protocols to offer, provide and document the service as well as processing the medicine request
...I have planned how I will use the technology I have available to assist in CMI provision
� Yes � No
External support and assistance
...I know how to access updates of CMIs as required
� Yes � No
FINAL REPORT
Appendix 25. A workflow strategy for CMI Provision
Prescription
presented
Pharmacist only medication
requested
Offer CMI again
Change in dosage
Valid reason
Medicine first
provided
Regular intervals
Change in CMI
PROFESSIONAL JUDGMENT to determine type of written information required
Referral to the pharmacist
Pharmacy assistant
offers CMI
Patient requests a
CMI
Verbal counselling
provided using the following topic areas as
a guide:- how to take the medicine
- how the medicine works and what benefits to expect
- the possible side effects
and what actions to take if a side effect occurs
CMI refusedCMI counselling provided
Move to quiet, private area
for consultation with required resources
Conduct counselling
Document counselling
Identify and offer any additional services that may
be beneficial to the patient
ST
EP
1S
TE
P 2
ST
EP
3S
TE
P 4
1.A 1.B
3.A 3.B
4.B4.A
Medicine
processed
Medicine
dispensed
(as required)
2.A
2.B2.C
Document counselling
Key: blue: key steps in the traditional process of dispensing/counselling
yellow: key steps in the provision of CMI that is BEYOND the traditional process of dispensing/counselling green: elements of CMI provision from PSA guidelines
FINAL REPORT