Renly Lim

Introduction: Spontaneous adverse drug reactions (ADRs) are underreported. Digital reporting systems are increasingly used to address this issue; however, limited knowledge exists about the barriers and facilitators influencing their use by consumers. Aim: To explore facilitators and barriers influencing consumers’ use of digital tools for ADR reporting, and to identify the factors, expectations and preferences that affect their engagement with these tools. Method: An exploratory qualitative descriptive study using semi-structured in-depth interviews was conducted among Australian adults who self-reported having experienced an ADR. Interviews were conducted face-to-face or via Zoom, audio-recorded, transcribed verbatim, and analysed inductively using reflexive thematic analysis. Themes were mapped onto domains of the Combined Technology Acceptance Model and Theory of Planned Behaviour (C-TAM-TPB) framework. Results: Fourteen participants were interviewed. Consumers expressed positive intentions to use online ADR reporting tools. Identified facilitators included user-friendly and accessible tools that are simple to complete, the use of images to aid comprehension, integration with existing patient health records, the ability to submit reports to both healthcare professionals and regulators, and a tool designed specifically for consumers using layperson language. Identified barriers included lack of awareness that consumers could report ADRs using online tools, the need for registration, complex medical terminology, compulsory fields, and the absence of feedback after submission. Conclusion: Consumers were willing to use online ADR reporting tools but were largely unaware of their existence. Enhancing usability through user-friendly design, and reporting forms specifically designed for consumers may increase engagement. Addressing barriers such as lack of awareness, registration requirements, medical jargon, and lack of feedback may improve usability and contribute to strengthening pharmacovigilance systems.

Background: Fertility rates in Australia have been declining over recent decades, reaching a record low total fertility rate of 1.48 births per woman in 2024. Concurrently, vasectomy remains widely accessible and increasingly normalised as a permanent contraceptive option. Despite extensive commentary on falling birth rates, no contemporary Australian study has examined vasectomy rates relative to birth rates over time. We aimed to compare population level vasectomy and birth rates across Australian jurisdictions and age groups. Study design: Nationwide retrospective time-series study. Retrospective population-based study using Medicare Benefits Schedule item 37623 to identify vasectomy procedures performed between July 2015 and December 2024. Rates were calculated per 100,000 male population using quarterly Australian Bureau of Statistics (ABS) population estimates and summarised as rolling 12-month averages. Birth rates were derived using matched ABS data for women across equivalent age strata (18–24, 25–34, 35–44 years). Results: Vasectomy rates increased nationally from 32 per 100,000 in 2016 to 55 per 100,000 in 2023 before declining modestly in 2024. Birth rates declined from 5,200 to 3,800 per 100,000 over the same period. Trends were consistent across states and age groups, with the greatest vasectomy uptake in men aged 35–44 years. Conclusion: Australia is undergoing a demographic shift characterised by rising vasectomy uptake and declining fertility. We have observed changing secular trends in two related but distinct demographic indicators of reproductive intention. Ongoing monitoring of permanent and long-acting contraception is essential to understand evolving population dynamics and inform reproductive health policy. Short summary for non-experts: This nationwide study demonstrates that rising vasectomy uptake in Australia coincides with declining birth rates, particularly among men aged 35–44 years. Monitoring permanent contraceptive use alongside fertility trends may help clinicians and policymakers better understand changing reproductive intentions and inform future reproductive health planning. Short summary for non-experts: Australia’s birth rate has fallen to record lows, raising growing concerns about how changing reproductive choices may shape future society and healthcare needs. In this study, we found that vasectomy rates increased steadily across Australia between 2016 and 2024 while birth rates declined, particularly among adults aged 35-44 years. These findings suggest Australian men are increasingly choosing permanent contraception and highlight the need for ongoing monitoring of reproductive health trends to inform future policy and service planning.

Aims: The Black Triangle Scheme, introduced in 2018 in Australia, does not appear to have increased the quantity of adverse drug event (ADE) reports. This study evaluated healthcare professionals' (HCPs') and consumers' awareness of the scheme, its influence on intentions for future ADE reporting, and suggested improvements. Methods: A mixed‐methods study was conducted (August–December 2024) consisting of an online questionnaire and follow‐up interviews with HCPs (doctors, pharmacists, nurses) and consumers in Australia. Descriptive and qualitative data analyses were conducted. Results: A total of 405 participants completed the questionnaire (138 HCPs, 267 consumers). Half of the HCPs (52%) and a tenth of the consumers (10%) were aware of the scheme. After viewing the symbol, 66.2% reported being likely or very likely to report an ADE linked to a medicine carrying it. Twenty‐one participated in the interviews (11 HCPs, 10 consumers). Interviewees suggested various strategies to improve awareness, including social media, television, posters and printed labels. Most noted that the Black Triangle symbol, in its current form and placement within medicine leaflets, is easy to miss. Once the scheme's purpose was explained, participants described it as “very important” and a “good initiative” to enhance medicine safety. Interview participants expressed mixed views on the scheme's impact on their future ADE reporting. Conclusion: Awareness of the scheme was notably lower among consumers than HCPs. Once informed, most participants viewed the scheme favourably and indicated a greater likelihood of reporting. However, issues related to the visibility and meaning of the Black Triangle symbol were raised.

BACKGROUND Digital technologies have the potential to support proactive identification of early signs of medicine-related harms, including changes in sleep, physical activity, and cognition. The use of a centralised digital platform to support pharmacists in monitoring longitudinal health data and detecting medicine-related harms in this setting has not been evaluated. OBJECTIVE To develop and assess the feasibility of a digitally enabled pharmacist service to monitor signs and symptoms of medicine-related harms in residential aged care. METHODS The study was conducted in two phases. In Phase I, the establishment phase, health and medication data from participants’ records were exported into the TeleClinical Care (TCC-ADEPT) digital platform. Phase II comprised a 12-week feasibility study with assessments conducted at baseline, 4 weeks, 8 weeks, and 12 weeks. During this phase, the on-site residential aged care pharmacist monitored all participants using the centralised TCC-ADEPT platform. The digital technology intervention included collection of digital biomarkers to supplement information from patient care record and medication chart with subsequent display as longitudinal visualisations of change in residents’ health and medicine use using a cloud-based monitoring platform; TeleClinical Care. The aged care pharmacist monitored residents’ clinical, medicine, sleep, and physical activity data to identify signs and symptoms of medicine-related harms using the centralised platform and notified the residents’ general practitioners when necessary. The RE-AIM framework was used to evaluate the feasibility of the digitally informed pharmacist service. Assessments included service reach, changes in resident symptom scores as measured by the Edmonton Symptom Assessment Scale, medicine use, number of adverse events, cognitive scores as measured by the Montreal Cognitive Assessment, sleep and physical activity as measured by sleep sensor and accelerometer, number and types of pharmacist recommendations to general practitioners (GPs), and qualitative interviews. RESULTS Twenty-nine participants were enrolled in the study, with 27 completing the 12-week assessments. The average age was 86 years old, and 65% were female. There was a significant decrease in total numbers of adverse events at 12-weeks compared to baseline (45 at baseline, 27 at 12-weeks; p=0.006). There were no significant differences in changes in symptom scores, medicine use, cognitive scores, sleep, and physical activity. Overall, the pharmacist made 25 recommendations to the participants’ GP; with half (n=13, 52%) being implemented. Five residents, one family member, the on-site pharmacist, three staff members, and two members of senior management were interviewed to understand their views of the pharmacist service as well as facilitators and barriers to its delivery. Overall, participants reported positive views of the service, and senior management indicated an intention to continue using the service. CONCLUSIONS Our findings suggest that the digitally informed pharmacist service is feasible and has the potential to reduce adverse events due to medicines within the aged care setting. CLINICALTRIAL ACTRN12623000506695 INTERNATIONAL REGISTERED REPORT RR2-doi: 10.1136/bmjopen-2023-080148

Background: Over 80–90% of antimicrobial use occurs in primary health care, underscoring the need for specific data from this sector to inform practices and interventions to improve antimicrobial use. This study aimed to identify a wide range of research instruments in primary health care and qualitatively describe their structure, scope, and content. Methods: For the narrative review, we reviewed Medline (inception–November 2023) and agency/network websites to identify surveys on antimicrobial use prevalence in LMIC primary care. We applied no language restrictions and extracted survey instruments from publications or requested them from authors when unavailable. Results: We identified 450 studies and extracted 42 survey instruments issued between 1993 and 2023, all but one post-2000. These covered both multi-country (16.7%) and country-specific implementations across all WHO regions. Sampling units included households/consumers (24/42, 57.2%), health professionals (14/42, 33.3%), drug sellers (3/42, 7.1%), and bulk sales data (1/42, 2.4%). Surveys typically captured antimicrobial type, prescription status, and reason for use; AWaRe classification was mentioned only once. We found 13 stand-alone protocols on antimicrobial use and 4 on general medicine use. Conclusions: We identified diverse tools for measuring antimicrobial use in LMICs, though many lacked protocols or analytic support. Surveys often focused solely on antibiotics, used paper-based methods, and rarely referenced the AWaRe classification. Future efforts should broaden the scope beyond antibiotics, leverage digital data systems, include implementation protocols and analytic tools, report standardized indicators, and adopt AWaRe-related variables as a core criterion to strengthen AMU monitoring in PHC.

Background Risk management plans (RMPs) are a critical element of pharmacovigilance. However, few studies have examined the quality and type of information included in RMPs, and none has examined the RMPs in the Australian medicines regulatory context. Objectives This study aims to characterise safety concerns, particularly missing information listed in the current Australian RMPs for commonly used biologic medicines, and identify additional pharmacovigilance and risk minimisation activities proposed to address identified gaps. Methods A descriptive review of RMPs included in the Australian Public Assessment Reports (2009–2024) was performed for 15 biologic medicines approved for use and universally funded in Australia for inflammatory arthropathies, inflammatory bowel diseases and inflammatory skin conditions. We extracted and quantified safety concerns (important identified risks, important potential risks and missing information) from the latest Australian Public Assessment Reports, and further categorised missing information by specific populations and conditions. We then qualitatively described the additional activities proposed. Results There were 246 safety concerns listed for the 15 medicines of interest: 85 important identified risks (34.6%), 81 important potential risks (32.9%) and 80 instances of missing information (32.5%). More than half (n = 9, 60%) of the reviewed medicines listed children and adolescents as the most common populations with missing information. Pregnant women (n = 8, 53%) and those with hepatic and renal impairment (n = 7, 47%) were also commonly listed as having missing information. Additional pharmacovigilance activities were proposed for two thirds of the medicines (n = 10, 77%) where missing information was listed. Only one third of the reviewed medicines (n = 5, 33%) had specific proposals or protocols listed in the current Australian Public Assessment Reports to address missing information. Conclusions Our study identified important gaps in RMPs for commonly used biologic medicines at the post-market phase. Despite some medicines having an extensive market history, these safety concerns remain unaddressed. Regular monitoring and critical review of RMPs are recommended to prioritise post-market studies and address outstanding safety concerns.

The adoption of technology, particularly for monitoring the effects of medications in residential aged care (nursing home), has been slow. Ageing populations have led to increased demand for residential aged care globally, resulting in a growing imperative to implement technological solutions to meet the complex healthcare and medication needs of older people in residential aged care. This commentary explores the potential for and the challenges associated with implementing technological interventions within residential aged care to improve monitoring of medication effects. Drawing on insights from two implementation trials, specifically the Reducing Medicine-induced Deterioration and Adverse Reactions and A Digitally Enabled Pharmacist Service to detecT medicine harms in residential aged care, we discuss the unique challenges and opportunities arising from the real-world applications of digital technologies for medication safety in aged care.

Background: Adverse medicine events (AMEs) are unintended effects that occur following administration of medicines. Up to 70% of AMEs are not reported to, and hence remain undetected by, health care professionals and only 6% of AMEs are reported to regulators. Increased reporting by consumers, health care professionals, and pharmaceutical companies to medicine regulatory authorities is needed to increase the safety of medicines. Objective: We describe a project that aims to co-design a digital reporting platform to improve detection and management of AMEs by consumers and health care professionals and improve reporting to regulators. Methods: The project will be conducted in 3 phases and uses a co-design methodology that prioritizes equity in designing with stakeholders. Our project is guided by the Consolidated Framework for Implementation Research. In phase 1, we will engage with 3 stakeholder groups—consumers, health care professionals, and regulators—to define digital platform development standards. We will conduct a series of individual interviews, focus group discussions, and co-design workshops with the stakeholder groups. In phase 2, we will work with a software developer and user interaction design experts to prototype, test, and develop the digital reporting platform based on findings from phase 1. In phase 3, we will implement and trial the digital reporting platform in South Australia through general practices and pharmacies. Consumers who have recently started using medicines new to them will be recruited to use the digital reporting platform to report any apparent, suspected, or possible AMEs since starting the new medicine. Process and outcome evaluations will be conducted to assess the implementation process and to determine whether the new platform has increased AME detection and reporting. Results: This project, initiated in 2023, will run until 2026. Phase 1 will result in persona profiles and user journey maps that define the standards for the user-friendly platform and interactive data visualization tool or dashboard that will be developed and further improved in phase 2. Finally, phase 3 will provide insights of the implemented platform regarding its impact on AME detection, management, and reporting. Findings will be published progressively as we complete the different phases of the project. Conclusions: This project adopts a co-design methodology to develop a new digital reporting platform for AME detection and reporting, considering the perspectives and lived experience of stakeholders and addressing their requirements throughout the entire process. The overarching goal of the project is to leverage the potential of both consumers and technology to address the existing challenges of underdetection and underreporting of AMEs to health care professionals and regulators. The project potentially will improve individual patient safety and generate new data for regulatory purposes related to medicine safety and effectiveness. International Registered Report Identifier (IRRID): DERR1-10.2196/60084

Background Reporting of adverse drug events (ADEs) to regulatory authorities remains low, particularly among consumers. Objectives To explore stakeholders’ views on the development and use of a digital platform to improve ADE reporting by consumers to the regulatory authority in Australia, i.e., the Therapeutic Goods Administration. Methods A qualitative study was conducted using semi-structured interviews, focus group discussions (FGDs), and co-design workshops with consumers, healthcare professionals (HCPs), and regulators. The interview recordings were transcribed verbatim, coded, and analysed thematically according to the Capability, Opportunity, Motivation, Behaviour model. Findings of the FGDs and co-design workshops were incorporated to enhance and complement the insights gathered from the interviews. Results A total of 39 participants took part in the study (54 % consumers, 41 % HCPs, and 5 % regulators). Uncovered themes related to ADE reporting in general were: difficulty recognizing ADEs and health literacy, awareness about reporting ADEs (Capability); visibility of ADE reporting, professionals’ views on consumer ADE reporting, consumer education (Opportunity); the common good, benefit to the reporter, identifying ADEs worth reporting, and concern about reporting (Motivation). Additional identified themes specific to a new digital platform were: physical abilities (Capability); features that facilitate intuitive use, convenience and accessibility, user experience, integration with existing systems, trust, sharing experiences with others (Opportunity); and concern about using a reporting platform, and feedback loop (Motivation). Conclusions A cross-section of attitudes and values were obtained regarding ADE reporting in general and a new ADE reporting digital platform for consumers in Australia, which will inform its development, implementation and evaluation.

This study aimed to investigate the current knowledge and experiences of consumers in Australia on adverse drug reaction (ADR) reporting and their reasons for reporting or not reporting ADRs, with a focus on the use of digital tools for ADR reporting. Methods: A cross-sectional online survey was conducted among adults who had taken medicine in Australia. A structured questionnaire with multiple choice or Likert scale responses with an option for participants to provide free-text responses and pretested for face validity was used. Consumer characteristics, knowledge, and ADR reporting practices were analyzed using descriptive statistics and the chi-square test or Fisher’s exact test. Results: A total of 544 survey responses were included in the analysis. The majority of respondents were women (68%), and 22% were aged between 65 and 74 years. Fifty-eight percent (n = 317) of respondents knew that they could report ADRs to either the Therapeutic Goods Administration (TGA), state or territory government health department, or healthcare professionals. Three-quarters (n = 405) of respondents stated that they had experienced an ADR; of these, 36% reported an ADR to either the TGA, state or territory government health department, or healthcare professionals. Among those who reported ADRs, 58% were unaware that they could use digital tools to report ADRs. The main reason for not reporting was that they did not think the ADR was serious enough to report (39%). Conclusion: Over half of consumers knew that they could report ADR; however, improved consumer awareness about using digital tools for ADR reporting and increased ADR reporting is needed.