Vivien Tong

‘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

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.

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

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.

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.

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.

OTC Medication and Pharmaceutical Care

With the increasing availability and use of over-the-counter (OTC) or nonprescription medicines by consumers globally, pharmacists have an integral role in delivering pharmaceutical care to support safe and appropriate OTC medication use. This chapter provides an overview of OTC medication use within the context of primary care and self-care. It outlines the role of pharmacists in relation to OTC medicines, details the medication-centered and service-oriented systems for delivering pharmaceutical care relevant to consumer OTC medication use, and discusses current and future scopes of practice within the context of OTC medication and pharmaceutical care.

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.