Opt-in or opt-out health-care communication? A cross-sectional study.

BACKGROUND: Patients need medication and medical condition-related information to better self-manage their health. Health-care professionals (HCPs) should be able to actively provide information outside of one-on-one consultations; however, patient consent may be required. OBJECTIVE: To investigate the Australian public's preferences, and factors that may influence their preferences, towards an opt-in versus an opt-out approach to health communication. DESIGN: A cross-sectional study using a structured questionnaire administered via Computer-Assisted Telephone Interviewing. SETTING AND PARTICIPANTS: Participants across Australia who were adults, English-speaking and had a long-term medical condition. MAIN OUTCOME MEASURES: Preferences for opt-in vs opt-out approach to receiving follow-up tailored information. RESULTS: A total of 8683 calls were made to achieve the required sample size of 589 completed surveys. Many (346/589; 58.7%) indicated that they were interested in receiving tailored, ongoing follow-up information from their HCP. Nearly half (n = 281; 47.7%) preferred an opt-in service and 293/589 (49.7%) an opt-out service for receiving follow-up information. Reasons for preferring an opt-in service were being in control of the information received (n = 254); able to make a decision that is best for them (n = 245); opt-in service would save time for HCPs (n = 217); they may not want or need the information (n = 240). Many (n = 255) felt that an opt-out service should be part of the normal duty of care of their HCP and believed (n = 267) that this approach would ensure that everyone has access to information. CONCLUSIONS: Respondents were interested in receiving tailored information outside of consultation times. However, preferences for an opt-in or opt-out approach were divided.

Developing and user testing new pharmacy label formats-A study to inform labelling standards.

BACKGROUND: Dispensed prescription medicine labels (prescription labels) are important information sources supporting safe and appropriate medicines use. OBJECTIVE: To develop and user test patient-centred prescription label formats. METHODS: Five stages: developing 12 labels for four fictitious medicines of varying dosage forms; diagnostic user testing of labels (Round 1) with 40 consumers (each testing three labels); iterative label revision, and development of Round 2 labels (n = 7); user testing of labels (Round 2) with 20 consumers (each testing four labels); labelling recommendations. Evaluated labels stated the active ingredient and brand name, using various design features (eg upper case and bold). Dosing was expressed differently across labels: frequency of doses/day, approximate times of day (eg morning), explicit times (eg 7 to 9 AM), and/or explicit dosing interval. Participants' ability to find and understand medicines information and plan a dosing schedule were assessed. RESULTS: Participants demonstrated satisfactory ability to find and understand the dosage for all label formats. Excluding active ingredient and dosing schedule, 14/19 labels (8/12 in Round 1; 6/7 in Round 2) met industry standard on performance. Participants' ability to correctly identify the active ingredient varied, with clear medicine name sign-posting enabling all participants evaluating these labels to find and understand the active ingredient. When planning a dosing schedule, doses were correctly spaced if the label stated a dosing interval, or frequency of doses/day. Two-thirds planned appropriate dosing schedules using a dosing table. CONCLUSIONS: Effective prescription label formatting and sign-posting of active ingredient improved communication of information on labels, potentially supporting safe medicines use. PATIENT AND PUBLIC INVOLVEMENT: Consumers actively contributed to the development of dispensed prescription medicine labels. Feedback from consumers following the first round was incorporated in revisions of the labels for the next round. Patient and public involvement in this study was critical to the development of readable and understandable dispensed prescription medicine labels.

Exploring consumer opinions on the presentation of side-effects information in Australian Consumer Medicine Information leaflets.

BACKGROUND: Consumer Medicine Information (CMI) is a brand-specific and standardized source of written medicine information available in Australia for all prescription medicines. Side-effect information is poorly presented in CMI and may not adequately address consumer information needs. OBJECTIVE: To explore consumer opinions on (i) the presentation of side-effect information in existing Australian CMI leaflets and alternative study-designed CMIs and (ii) side-effect risk information and its impact on treatment decision making. DESIGN: Fuzzy trace, affect heuristic, frequency hypothesis and cognitive-experiential theories were applied when revising existing CMI side-effects sections. Together with good information design, functional linguistics and medicine information expertise, alternative ramipril and clopidogrel CMI versions were proposed. Focus groups were then conducted to address the study objectives. PARTICIPANTS AND SETTING: Three focus groups (n = 18) were conducted in Sydney, Australia. Mean consumer age was 58 years (range 50-65 years), with equal number of males and females. RESULTS: All consumers preferred the alternative CMIs developed as part of the study, with unequivocal preference for the side-effects presented in a simple tabular format, as it allowed quick and easy access to information. Consumer misunderstandings reflected literacy and numeracy issues inherent in consumer risk appraisal. Many preferred no numerical information and a large proportion preferred natural frequencies. CONCLUSIONS: One single method of risk presentation in CMI is unable to cater for all consumers. Consumer misunderstandings are indicative of possible health literacy and numeracy factors that influence consumer risk appraisal, which should be explored further.

'It's all there in black and white' - or is it? Consumer perspectives on the proposed Australian Medicine Information Box over-the-counter label format.

BACKGROUND: Over-the-counter (OTC) labels help support safe medication use by consumers. In 2012, the Australian Therapeutic Goods Administration (TGA) released a consultation paper proposing OTC label standardization to improve label quality via implementation of the Medicine Information Box (MIB) label. However, consumer opinions of the MIB and standardization of OTC labelling remain unexplored. OBJECTIVE: To explore consumer perspectives of OTC label standardization and the proposed MIB. DESIGN: Mock MIB labels were developed by the research team, guided by the TGA consultation paper, and used as interview stimulus material. PARTICIPANTS AND SETTING: Semi-structured interviews were conducted with 38 Australian and 39 UK adult participants. Participant perspectives on OTC label standardization, opinions on the MIB and perceived improvements were explored. All interviews were audio-recorded with permission, transcribed verbatim, and the content thematically analysed. RESULTS: Participants expressed a range of opinions towards OTC label standardization, from welcoming standardization to concern that important details may be overlooked. The MIB was generally positively received due to its perceived good information design and ease of navigation. Participants requested reordering of information-specifically, for the active ingredient to be moved to a less prominent position. Suggested improvements centred on content and design changes, for example colour, pictograms, bolding. CONCLUSIONS: Participants felt positively towards OTC label standardization and saw the MIB as a feasible standardized format to implement for OTC labels. Although they appreciated its good information design, they felt further improvements to its content and design are required to enhance its quality and usability.

Impact of a pharmacy-led screening and intervention in people at risk of or living with chronic kidney disease in a primary care setting: a cluster randomised trial protocol.

INTRODUCTION: Chronic kidney disease (CKD) is increasingly recognised as a growing global public health problem. Early detection and management can significantly reduce the loss of kidney function. The proposed trial aims to evaluate the impact of a community pharmacy-led intervention combining CKD screening and medication review on CKD detection and quality use of medicines (QUM) for patients with CKD. We hypothesise that the proposed intervention will enhance detection of newly diagnosed CKD cases and reduce potentially inappropriate medications use by people at risk of or living with CKD. METHODS AND ANALYSIS: This study is a multicentre, pragmatic, two-level cluster randomised controlled trial which will be conducted across different regions in Australia. Clusters of community pharmacies from geographical groups of co-located postcodes will be randomised. The project will be conducted in 122 community pharmacies distributed across metropolitan and rural areas. The trial consists of two arms: (1) Control Group: a risk assessment using the QKidney CKD risk assessment tool, and (2) Intervention Group: a risk assessment using the QKidney CKD plus Point-of-Care Testing for kidney function markers (serum creatinine and estimated glomerular filtration rate), followed by a QUM service. The primary outcomes of the study are the proportion of patients newly diagnosed with CKD at the end of the study period (12 months); and rates of changes in the number of medications considered problematic in kidney disease (number of medications prescribed at inappropriate doses based on kidney function and/or number of nephrotoxic medications) over the same period. Secondary outcomes include proportion of people on potentially inappropriate medications, types of recommendations provided by the pharmacist (and acceptance rate by general practitioners), proportion of people who were screened, referred, and took up the referral to visit their general practitioners, and economic and other patient-centred outcomes. ETHICS AND DISSEMINATION: The trial protocol has been approved by the Human Research Ethics Committee at the University of Sydney (2022/044) and the findings of the study will be presented at scientific conferences and published in peer-reviewed journal(s). TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12622000329763).

The evolving profile of cognitive pharmaceutical services in Australia.

Globally, the availability and delivery of cognitive pharmaceutical services (CPS) by pharmacists has expanded over time. Australia has been no exception to this trend, with government funding to support the provision of certain CPS significantly increasing over the last two decades. Whilst medication management services have been consistently funded by the government for more than 15 years, fluctuations in the funding of other CPS have been observed; for example, certain disease state management CPS and introduction of funded MedsChecks. Furthermore, legislative changes have broadened pharmacists' scope of practice and the CPS provided, contributing to an increase in user-pay services. Although the literature to date has highlighted positive impacts associated with CPS on economic, clinical and/or humanistic outcomes, context-specific, real world evidence for the benefits of CPS is much needed to ensure the profession engages in evidence-based practice. The aim of this commentary is to outline the changes in CPS provision and funding within the Australian context, the existing evidence for CPS, and highlight the implications for future research.

An in-depth examination of funded and unfunded cognitive pharmaceutical services.

Background: A substantial expansion in the scope of practice of community pharmacists has become evident over the years, with increased government remuneration pledged to support cognitive pharmaceutical services (CPS) delivery as part of the Australian Community Pharmacy Agreements. Exploring experiences in providing funded and unfunded CPS within the existing work environment will enable better understanding of community pharmacists' roles and responsibilities in delivering CPS. Objective: To explore pharmacists' roles, responsibilities, experiences, and perceived impact associated with delivering CPS. Methods: Qualitative semi-structured interviews (n = 25) were conducted with practising community pharmacists in Australia who were engaged in delivering CPS during the time when the Sixth Community Pharmacy Agreement (6CPA) was in effect. Verbatim transcripts were thematically analysed (inductive analysis). Results: All participants reported an expansion of services being provided in community pharmacies. Pharmacists offered a broad range of CPS within the community pharmacy setting, via 6CPA-funded and non-6CPA or unfunded initiatives. Almost all participants reported that their pharmacy provided 6CPA-funded initiatives such as dose administration aids, clinical interventions, MedsChecks/Diabetes MedsChecks, and Home Medicines Reviews. User-pay services being offered included pharmacist-led flu vaccinations, opioid substitution therapy, sleep apnoea services, and absence from work certificates, among other services. However, profit margins on user-pay services were minimal. CPS provision was seen to have positive impacts at patient and health care system levels. Pharmacists felt they enabled timely and convenient access to health care for patients in the community pharmacy setting, and facilitated quality use of medicines, which in turn had positive impact on the community pharmacy business. Conclusions: A prominent shift in the provision of CPS was evident. Professional services provision has become the status quo for the practice of the profession, indicative of a likely shift in the work value of community pharmacists. Pharmacists should be further recognised professionally and financially for their contributions as health care professionals within the broader health care system.

Consumer opinions on adverse events associated with medical devices.

INTRODUCTION: Post-market surveillance of medical devices relies on compulsory and voluntary reports. Although direct consumer reporting of medical device-related adverse events (AEs) is available in Australia, the proportion of consumer reports has remained low. Limited qualitative research has previously explored consumer insights on AEs associated with medical devices and in particular, AE reporting. OBJECTIVE: To explore consumer opinions on AEs related to medical devices, and their knowledge of, experiences with, and views on, the reporting of medical device-related AEs. METHODS: Focus groups (n = 4; total of 29 participants) were conducted in metropolitan Sydney, Australia. Focus group discussions of approximately 1.5 h in length centred on consumers' understanding of AEs, opinions on AEs and their previous experiences, views on medical device benefits and harms, and actions taken (or potential actions) in response to AEs. With participant consent, discussions were audio-recorded, transcribed verbatim, and thematically analysed. RESULTS: Participants regarded medical device-related side effects to be unexpected AEs associated with their use. Where there was a clear need for the medical device itself, potential improvement in quality of life took precedence over potential harms. Most participants had not experienced negative issues with their medical device(s). There was poor awareness among participants of an existing direct consumer AE reporting system for medical devices. Despite this, the value of reporting was acknowledged. Severity of the AE was a key motivator for potential AE reporting. CONCLUSIONS: Further efforts are necessary to improve consumer awareness of available AE reporting systems to better support post-market surveillance and safe medical device use.

Receipt and use of spoken and written over-the-counter medicine information: insights into Australian and UK consumers' experiences.

OBJECTIVES: To explore Australian and UK consumers' receipt and use of spoken and written medicine information and examine the role of leaflets for consumers of over-the-counter (OTC) medicines. METHODS: Semistructured interviews were conducted with 37 Australian and 39 UK consumers to explore information received with their most recent OTC medicine purchase, and how information was used at different times post-purchase. Interviews were audio-recorded, transcribed verbatim and thematically analysed. KEY FINDINGS: Similarities were evident between the key themes identified from Australian and UK consumers' experiences. Consumers infrequently sought spoken information and reported that pharmacy staff provided minimal spoken information for OTC medicines. Leaflets were not always received or wanted and had a less salient role as an information source for repeat OTC purchases. Consumers tended not to read OTC labels or leaflets. Product familiarity led to consumers tending not to seek information on labels or leaflets. When labels were consulted, directions for use were commonly read. However, OTC medicine information in general was infrequently revisited. CONCLUSIONS: As familiarity is not an infallible proxy for safe and effective medication use, strategies to promote the value and use of these OTC medicine information sources are important and needed. Minimal spoken information provision coupled with limited written information use may adversely impact medication safety in self-management.

Developing alternative over-the-counter medicine label formats: How do they compare when evaluated by consumers?

BACKGROUND: In recent years, the Australian Therapeutic Goods Administration (TGA) has proposed implementing a standardized over-the-counter (OTC) medicine label. However, there were mixed consumer opinions regarding a label proposed in 2012 and limited evidence demonstrating the usability of the revised (2014) format. OBJECTIVE: To develop and examine the usability of alternative OTC medicine label formats for standardization, and explore consumer perspectives on the labels. MATERIALS AND METHODS: Four alternative labels were developed for the exemplar medicine diclofenac. One was based on the Medicine Information label proposed by the TGA ('Medicine Information'), one was based on the U.S. Drug Facts label ('Drug Facts'), and two were based on suggestions proposed by consumers in the earlier needs analysis phase of this research (referred to as the 'Medicine Facts' and 'Consumer Desires' label formats). Five cohorts of 10 participants were recruited. Each cohort was assigned to user test one of the alternative labels or an existing label for a proprietary diclofenac product (which acted as a comparator) for diagnostic purposes. Each participant then provided feedback on all 5 labels. Each interview consisted of the administration of a user testing questionnaire, measuring consumers' ability to find and understand key points of information, and a semi-structured interview exploring consumer perspectives. RESULTS: Overall, all 4 alternative label formats supported consumers' ability to find and understand key points. The existing comparator label was the poorer label with respect to participants' ability to find and understand key points. Factors such as perceived usability, color, design, content, and/or content ordering impacted consumer preferences. The 'Consumer Desires' or 'Drug Facts' label formats were most often preferred by consumers for use as the standardized OTC label over the TGA proposed format. CONCLUSIONS: All alternative label formats demonstrated satisfactory usability and could be considered for use in OTC label standardization. User testing of OTC labels and consumer feedback received as part of the testing process can assist in the refinement of OTC labeling to ensure that implemented policies are evidence-based.

Comparative User Testing of Australian and UK Over-the-Counter Labels and Leaflets for Diclofenac.

BACKGROUND: Limited research has evaluated the consumer usability of written information available with similar over-the-counter (OTC) products in different countries. This study evaluated the usability of labels and leaflets for Australian and UK OTC diclofenac products and explored consumer perspectives on their design, content, usability, and potential improvements. METHODS: Australian and UK OTC diclofenac products were selected for user testing. Demographically matched groups of Australian and UK consumers were recruited to user test each label and leaflet set to determine whether 9 salient clinical messages could be found and understood. Consumer perspectives on the tested label and leaflet were explored using semi-structured interviews as part of user testing. RESULTS: Forty consumers user tested the Voltaren Rapid 25 (Australia) and Voltarol Pain-eze Extra Strength 25-mg tablets (UK) information (10 participants per brand per country). Dosage, maximum daily dose, and contraindications information was found and understood by most (≥9/10 per group), except the Voltaren dosage which was misunderstood by 4/20. However, 12/20 could not locate the maximum duration of continuous use in the Voltaren leaflet. Participants had difficulty determining that another nonsteroidal anti-inflammatory drug could not be used with diclofenac (7/20 and 9/20 understood this in the Voltaren and Voltarol groups, respectively). Suggested label and leaflet improvements included increased font size, bolding/highlighting, and color. CONCLUSION: When evaluated in both countries, not all key clinical information was effectively communicated by information accompanying Australian and UK diclofenac products. Improvements in how information is communicated are needed.

Consumer opinions on adverse events associated with medicines and vaccines.

INTRODUCTION: Despite the availability of an Australian consumer adverse event (AE) reporting system for over 50 years, reporting rates remain low. A comprehensive understanding of consumer perceptions and experiences regarding AEs is needed to further ascertain factors impacting their engagement in AE reporting. AIM: The aim of this study was to explore consumer opinions about AEs potentially associated with medicines and vaccines, and their experiences and understanding of managing and reporting AEs. METHODS: Six focus groups were conducted across metropolitan Sydney with a total of 48 adult participants. A semi-structured focus group topic guide was developed to explore consumers' understanding, experiences, and actions taken in relation to AEs; and perspectives on managing treatment benefits and harms. Discussions were audio-recorded with participant permission and transcribed verbatim. Transcripts were thematically analyzed. RESULTS: Consumers acknowledged the potential for side effects (SEs), however inaccurately estimated SE risk in response to verbal descriptors such as "common." Consumer appraisal of treatment benefits and harms was influenced by factors such as medical condition(s), previous experiences, and beliefs. Although many had experienced SEs, consumers only reported them if considered severe or troublesome. Minimal awareness of consumer AE reporting systems was evident. Doctors were the primary avenue for reporting; consumers preferred doctors to act as the intermediary in reporting AEs to an independent body. CONCLUSION: Consumers' lack of awareness of AE reporting systems was evident. With the complexities inherent in benefit/harm risk appraisal, information seeking, and AE reporting preferences, better consumer understanding of AEs and the systems available for reporting is needed.

User testing as a method for identifying how consumers say they would act on information related to over-the-counter medicines.

BACKGROUND: User testing evaluates written medicine information (WMI) usability by examining participants' ability to find and understand information. It can also be an effective method to determine how consumers say they will act on information on an over-the-counter (OTC) label. OBJECTIVE: To examine consumers' proposed behaviors regarding dosage and storage as a measure of a medicine label's usability and consumers' functional health literacy. MATERIAL AND METHODS: User testing of 5 diclofenac OTC labels (by 50 subjects; 10 per label) measured consumers' ability to find and understand key points of information using a 13-item questionnaire. Consumers were required to elaborate on their behavior in regard to 2 additional questions: 1) when they would take diclofenac if they had constant back pain from 8 am (dosage-related) and; 2) where they would store it in their home (storage-related). Responses were transcribed verbatim, and coded by 2 pharmacists. RESULTS: Appropriate dosing for constant back pain was reported by 29 consumers. However, dosing intervals shorter than the specified 8 h were often reported (n = 19), due to adjusting intervals to accommodate up to the maximum of 8 tablets in 24 h, desire for pain relief, and/or pragmatic dosing (e.g. around bedtime). Only 29 consumers stated completely appropriate storage location examples (e.g. medicine cabinet). CONCLUSIONS: Consumers may act inappropriately on OTC label information about dosage and/or storage, which could potentially adversely impact medication use. User testing can contribute to the development of high quality WMI and help identify where label wordings are inappropriate for the health literacy levels of consumers.

Consumer Opinions on Existing and Proposed Australian Over-the-Counter Medicine Labeling Strategies in Comparison With the Standardized US Drug Facts Label.

BACKGROUND: With common over-the-counter (OTC) medication use, OTC labels as medicine information sources must be of high quality and usability. Standardized OTC labeling has been proposed in Australia using the Medicine Information Box (MIB), modeled on the US Drug Facts label. However, limited research has explored consumer opinions on existing nonstandardized Australian OTC, US Drug Facts, and proposed MIB labels. Therefore, this study aimed to explore consumer opinions on all 3 groups of OTC labels. METHODS: Three focus groups (N = 21 participants) were conducted in Sydney, Australia. Participants were shown existing Australian OTC labels, US Drug Facts labels, and mock MIB formats based on the Australian Therapeutic Goods Administration proposal. Discussions were audio recorded, transcribed verbatim, and thematically analyzed. RESULTS: Participants expressed varying opinions regarding existing nonstandardized Australian OTC labels' content and design, from acknowledgment of positive aspects (clear headings, relevant content) to decreased perceived readability (suboptimal color use, font size) and content discrepancies. Participants identified key Drug Facts and MIB label characteristics that contributed to perceived usability and format clarity (good headings, black-and-white format). Many preferred the Drug Facts label because of its greater perceived clarity and usability. Missing content (inactive ingredients, further contact details) were identified and consequently became opportunities for MIB improvement. CONCLUSIONS: Most participants seemed to prefer the US Drug Facts label, partly because of its perceived completeness. These findings suggest further improvements for the proposed MIB as a step toward Australian OTC label standardization.

Consumer interpretation of ramipril and clopidogrel medication risk information - implications for risk communication strategies.

PURPOSE: Side effects and side-effect risk information can be provided using written medicine information. However, challenges exist in effectively communicating this information to consumers. This study aimed to explore broad consumer profiles relevant to ramipril and clopidogrel side-effect risk information interpretation. METHODS: Three focus groups were conducted (n=18 consumers) exploring consumer perspectives, understanding and treatment decision making in response to ramipril and clopidogrel written medicine information leaflets containing side effects and side-effect risk information. All discussions were audio recorded, transcribed verbatim, and analyzed to explore consumer profiles pertaining to side-effect risk appraisal. RESULTS: Three consumer profiles emerged: glass half-empty, glass half-full, and middle-of-the-road consumers, highlighting the influence of perceived individual susceptibility, interpretation of side-effect risk information, and interindividual differences, on consumers' understanding of side-effect risk information. All profiles emphasized the importance of gaining an understanding of individual side-effect risk when taking medicines. CONCLUSION: Written side-effect risk information is not interpreted uniformly by consumers. Consumers formulated their own construct of individual susceptibility to side effects. Health care professionals should consider how consumers interpret side-effect risk information and its impact on medication use. Existing risk communication strategies should be evaluated in light of these profiles to determine their effectiveness in conveying information.

Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review.

BACKGROUND: Over-the-counter medicines must be supplied with appropriate, user-friendly medicine information to satisfactorily support consumer self-management and safe use. Product labels and written medicine information leaflets are highly accessible over-the-counter medicine information sources for consumers. Factors such as comprehensibility and design underpin the usefulness of over-the-counter labels and leaflets and should be further examined to better inform future optimisation strategies. Aim of the review To undertake an in-depth exploration of studies that have evaluated design and/or comprehensibility of over-the-counter labels and written medicine information leaflets Methods Database searches were performed using Medline, Embase, International Pharmaceutical Abstracts and PubMed. Studies exploring over-the-counter medicine label and/or leaflet comprehensibility and/or design were identified. Additional author and reference list searches were performed to identify studies which met the inclusion criteria and key terms. RESULTS: A total of 35 studies were included in the review, which explored OTC medicine information design and/or comprehensibility via researcher evaluation alone (n = 8) or with consumers (n = 27). Researcher-determined over-the-counter written medicine information leaflet readability (n = 4) has highlighted suboptimal readability, with few studies evaluating over-the-counter leaflet performance using the gold standard method of 'user testing' with consumers (n = 2). Variable over-the-counter label comprehensibility was identified in consumer studies, ranging from satisfactory understanding to considerable misunderstanding. The review findings indicate that consumer outcomes were influenced by information design, where implementation of good design principles generally improved over-the-counter label and leaflet performance. Significant diversity existed in study design aspects such as sampling frames, sample sizes and tools used to evaluate over-the-counter medicine information, which hindered the ability to adequately compare various study aspects and findings. CONCLUSION: A wide spectrum of consumer understanding of over-the-counter medicine labels is evident in the literature, with limited studies examining over-the-counter written medicine information leaflet comprehensibility with consumers. The application of good information design principles in over-the-counter labels and leaflets contribute to improved performance. Well-designed consumer studies are needed to ascertain and optimise over-the-counter label and leaflet performance.