In recent years, there has been a surge in the development of AI-based Software as a Medical Device (SaMD), particularly in visual specialties such as dermatology. In Australia, the Therapeutic Goods Administration (TGA) regulates AI-based SaMD to ensure its safe use. Proper labelling of these devices is crucial to ensure that healthcare professionals and the general public understand how to use them and interpret results accurately. However, guidelines for labelling AI-based SaMD in dermatology are lacking, which may result in products failing to provide essential information about algorithm development and performance metrics. This review examines existing labelling guidelines for AI-based SaMD across visual medical specialties, with a specific focus on dermatology. Common recommendations for labelling are identified and applied to currently available dermatology AI-based SaMD mobile applications to determine usage of these labels. Of the 21 AI-based SaMD mobile applications identified, none fully comply with common labelling recommendations. Results highlight the need for standardized labelling guidelines. Ensuring transparency and accessibility of information is essential for the safe integration of AI into health care and preventing potential risks associated with inaccurate clinical decisions.

OBJECTIVE: Artificial intelligence (AI) holds remarkable potential to improve care delivery in dermatology. End users (health professionals and general public) of AI-based Software as Medical Devices (SaMD) require relevant labelling information to ensure that these devices can be used appropriately. Currently, there are no clear minimum labelling requirements for dermatology AI-based SaMDs.
METHODS: Common labelling recommendations for AI-based SaMD identified in a recent literature review were evaluated by an Australian expert panel in digital health and dermatology via a modified Delphi consensus process. A nine-point Likert scale was used to indicate importance of 10 items, and voting was conducted to determine the specific characteristics to include for some items. Consensus was achieved when more than 75% of the experts agreed that inclusion of information was necessary.
RESULTS: There was robust consensus supporting inclusion of all proposed items as minimum labelling requirements; indication for use, intended user, training and test data sets, algorithm design, image processing techniques, clinical validation, performance metrics, limitations, updates and adverse events. Nearly all suggested characteristics of the labelling items received endorsement, except for some characteristics related to performance metrics. Moreover, there was consensus that uniform labelling criteria should apply across all AI categories and risk classes set out by the Therapeutic Goods Administration.
CONCLUSIONS: This study provides critical evidence for setting labelling standards by the Therapeutic Goods Administration to safeguard patients, health professionals, consumers, industry, and regulatory bodies from AI-based dermatology SaMDs that do not currently provide adequate information about how they were developed and tested.

Many countries have adopted warning labels for combustible tobacco products, yet little research exists describing tobacco warning characteristics globally and to what extent they meet the WHO Framework Convention for Tobacco Control (FCTC) Guidelines. This study evaluates characteristics of combustible tobacco warnings.
We conducted a content analysis to describe the overall landscape of warnings using descriptive statistics and compared to the WHO FCTC Guidelines.
We searched existing warning databases for combustible tobacco warnings from English-speaking countries. We compiled warnings meeting inclusion criteria and coded for message and image characteristics using a pre-defined codebook.
Characteristics of combustible tobacco warning text statements and warning images were the primary study outcomes. There were no secondary study outcomes.
We identified a total of 316 warnings from 26 countries or jurisdictions worldwide. Of these warnings, 94% included warning text and an image. Warning text statements most often described health effects to the respiratory (26%), circulatory (19%) and reproductive systems (19%). Cancer was the most frequently mentioned health topic (28%). Fewer than half of warnings included a Quitline resource (41%). Few warnings included messages about secondhand smoke (11%), addiction (6%) or cost (1%). Of warnings with images, most were in colour and showed people (88%), mostly adults (40%). More than 1 in 5 warnings with images included a smoking cue (ie, cigarette).
While most tobacco warnings followed WHO FCTC guidance on effective tobacco warnings, such as communicating health risks and inclusion of images, many did not include local Quitline or cessation resources. A sizeable minority include smoking cues that could inhibit effectiveness. Full alignment with WHO FCTC guidelines will improve warnings and better achieve the WHO FCTC objectives.

Guidelines for sustainable use of moxidectin were established in 2020. This study aimed to identify how Scottish sheep farmers are using this key endectocide and estimate its effectiveness against gastrointestinal nematodes.
Questionnaires were distributed to sheep farmers across Scotland, and analysis focused on moxidectin use in relation to Sustainable Control of Parasites in Sheep (SCOPS) guidelines. Farmers using moxidectin in their flock volunteered to submit post-treatment sheep faecal samples, which were analysed for the presence of gastrointestinal nematodes using faecal egg counts with polymerase chain reaction to determine species.
Despite 70% of farmers using moxidectin in 2020, knowledge levels varied: 24% of farmers included other anthelmintics when asked about moxidectin use. Moxidectin was used for a wide variety of reasons, and most farmers did not consistently follow SCOPS guidelines. Despite only 2 of 76 farmers reporting failure of moxidectin treatment, gastrointestinal nematodes were found following moxidectin treatment on five out of six farms tested and included Teladorsagia circumcincta, Cooperia curticei, Haemonchus contortus and Nematodirus sp.
Findings from this project indicate the need for improved anthelmintic product labelling and farmer support to encourage sustainable use. The presence of nematodes in treated animals is suggestive of anthelmintic resistance.

The World Health Organization recommends immunization with inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine during pregnancy. Yet, product labelling information for IIV and Tdap sends a different message. In a previous study, we developed evidence-based statements about vaccination in pregnancy that could be included in product information. This study compares healthcare providers\' perceptions of the revised statements to those currently used in vaccine product labelling information.
A 30-item online survey with qualitative and quantitative components was distributed to Canadian maternal healthcare providers via professional organizations and public health. Participants read excerpts from revised and existing IIV and Tdap product labelling information and answered questions about how they perceived the safety and effectiveness of the vaccines, whether they would recommend each vaccine during pregnancy, and which statements they preferred.
From June to August 2018, 449 healthcare providers completed the survey, including physicians (45%), nurses (24%), midwives (27%) and others (5%). Most participants perceived the vaccines to be safe and effective based on the revised statements. Over twice as many participants said they would recommend the IIV and Tdap vaccines in pregnancy based on the revised rather than the existing statements (64% versus 21% for IIV and 63% versus 27% for Tdap). Most participants selected that the revised statements better explained the risks and benefits of vaccination in pregnancy (65% versus 21% for IIV; 51% versus 27% for Tdap). Qualitative comments highlighted the strengths of the revised statements and areas for improvement.
The majority of participants demonstrated preferences for the revised IIV and Tdap product label statements over the existing statements. Comments suggested the revised statements include improvements to the evidence-base and readability. Involving stakeholders improved the development of product labelling information, but further improvement is needed to support the evidence-based use of vaccines in pregnancy.

The UK low-risk drinking guidelines (LRDG) recommend not regularly drinking more than 14 units of alcohol per week. We tested the effect of different pictorial representations of alcohol content, some with a health warning, on knowledge of the LRDG and understanding of how many drinks it equates to.
Parallel randomized controlled trial.
On-line, 25 January-1 February 2019.
Participants (n = 7516) were English, aged over 18 years and drink alcohol.
The control group saw existing industry-standard labels; six intervention groups saw designs based on: food labels (serving or serving and container), pictographs (servings or containers), pie charts (servings) or risk gradients. A total of 500 participants (~70 per condition) saw a health warning under the design.
Primary outcomes: (i) knowledge: proportion who answered that the LRDG is 14 units; and (ii) understanding: how many servings/containers of beverages one can drink before reaching 14 units (10 questions, average distance from correct answer).
In the control group, 21.5% knew the LRDG; proportions were higher in intervention groups (all P < 0.001). The three best-performing designs had the LRDG in a separate statement, beneath the pictograph container: 51.1% [adjusted odds ratio (aOR) = 3.74, 95% confidence interval (CI) = 3.08-4.54], pictograph serving 48.8% (aOR = 4.11, 95% CI = 3.39-4.99) and pie-chart serving, 47.5% (aOR = 3.57, 95% CI = 2.93-4.34). Participants underestimated how many servings they could drink: control mean = -4.64, standard deviation (SD) = 3.43; intervention groups were more accurate (all P < 0.001), best performing was pictograph serving (mean = -0.93, SD = 3.43). Participants overestimated how many containers they could drink: control mean = 0.09, SD = 1.02; intervention groups overestimated even more (all P < 0.007), worst-performing was food label serving (mean = 1.10, SD = 1.27). Participants judged the alcohol content of beers more accurately than wine or spirits. The inclusion of a health warning had no statistically significant effect on any measure.
Labels with enhanced pictorial representations of alcohol content improved knowledge and understanding of the UK\'s low-risk drinking guidelines compared with industry-standard labels; health warnings did not improve knowledge or understanding of low-risk drinking guidelines. Designs that improved knowledge most had the low-risk drinking guidelines in a separate statement located beneath the graphics.

To test whether alcohol labels with a cancer warning and national drinking guidelines are an effective tool for supporting more informed and safer alcohol consumption among drinkers.
Using a quasi-experimental design, pre-post surveys were conducted with 1647 cohort participants systematically selected in liquor stores in two matched sites in Canada in 2017-2018. Enhanced labels designed according to best practices for effective product labels were applied to alcohol containers in the liquor store in the intervention site for one month, and usual practice continued in the comparison site. Generalized estimating equations tested the differences between sites over time in label salience and processing, and self-reported impact of the labels on drinking behaviours.
After the intervention, recall of the cancer warning label increased to a greater extent in the intervention versus comparison site (adjusted odds ratio (AOR) = 32.2, 95% CI = 5.4, 191.1), but not the national drinking guideline label (AOR = 2.7, 95% CI = 0.2, 31.8). There were significant label effects in the intervention versus comparison site for reading (AOR = 1.8, 95% CI = 1.3, 2.5), thinking about (AOR = 2.0, 95% CI = 1.4, 2.9), and talking with others about (AOR = 2.1, 95% CI = 1.3, 3.6) the labels, as well as self-reported impact to cut down on drinking (AOR = 2.5, 95% CI = 1.3, 4.7) and to drink less (AOR = 2.4, 95% CI = 1.3, 4.3).
Alcohol labels with a cancer warning and national drinking guidelines do a better job conveying risk information and promoting safer consumption than existing practices. Industry has a legal duty to adequately inform consumers about their products and should be mandated to include key information on alcohol containers.

Alcohol labels are one strategy for communicating health information to consumers. This study tested the extent to which consumers recalled alcohol labels with national drinking guidelines and examined the impact of labels on awareness and knowledge of the guidelines.
A quasi-experimental study was conducted in two jurisdictions in northern Canada examining the impact of labels on the following outcomes: unprompted and prompted recall of the drinking guideline label message, awareness of the drinking guidelines, and knowledge of the daily and weekly recommended drink limits. The intervention site applied labels with national drinking guidelines, a cancer warning, and standard drink information to alcohol containers in its liquor store, whereas the comparison site did not apply these labels. In total, 2,049 cohort participants in both sites were recruited to complete surveys before and at two time points after the intervention. Changes in outcomes were examined using generalized estimating equations.
After the intervention, unprompted and prompted recall of the drinking guideline label message increased more in the intervention versus comparison site (adjusted odds ratio [AOR] = 10.8, 95% CI [0.9, 127.6]; AOR = 7.0, 95% CI [3.3, 14.9], respectively). Awareness of the drinking guidelines increased 2.9 times more in the intervention versus comparison site (AOR = 2.9, 95% CI [2.0, 4.3]). In addition, knowledge of the daily and weekly drink limits increased 1.5 and 1.4 times more in the intervention versus comparison site, respectively (daily: AOR = 1.5, 95% CI [1.0, 2.1]; weekly: AOR = 1.4, 95% CI [1.0, 2.0]).
Enhanced alcohol labels get noticed and may be an effective population-level strategy for increasing awareness and knowledge of national drinking guidelines.

Australia has an ageing population. Given the concomitant increase in the numbers and proportion of risky drinkers among older adults, research examining contributory factors is a priority. The current study examined older adults\' estimates of the NHMRC low-risk drinking guidelines, consumption patterns and associated harms and self-identification of drinking type.
Data from respondents aged 50+ years (N = 11 886) in the 2016 National Drug Strategy Household Survey were subjected to secondary analyses. Estimates of low-risk drinking levels, perceived level of harm from current drinking, self-identification of drinking type and awareness of standard drinks and labelling were included. Data were examined for those aged 50-59 years and 60+.
Seventeen percent of older Australians drank at both long-term and short-term risk levels. Approximately 39% of males and 11% of females overestimated the long-term low-risk levels and 54% of males and 20% of females overestimated the short-term low-risk levels. Overestimation was highest among risky drinkers. Most older risky drinkers were aware of standard drinks and labelling; however, less than half perceived their drinking as harmful, instead identifying as social drinkers.
Although substantial gaps are evident in older respondents\' estimates of low-risk drinking, additional public awareness campaigns are likely to be of limited use. Older peoples\' engagement with the public health system presents \'windows of opportunity\' to provide targeted, age-appropriate harm reduction strategies. Appropriate intervention and policy responses are required to direct resources to this emerging area of concern.

Rosacea is a widespread inflammatory skin disease that is chronically recurrent and affects predominately the central parts of the face. Affected individuals typically react to numerous cosmetics with redness, burning, and/or worsening of the complexion. Consequently, there is a high demand for dermocosmetics that do not provoke such reactions and are suitable for use in rosacea. The present guideline of the Society for Dermopharmacy describes the requirements that dermocosmetics for use in rosacea should meet. They include, inter alia, methods to prove the efficacy of and tolerance to these cosmetics, as well as the product documentation that the manufacturer or the distributing company should make available to professionals, like dermatologists and pharmacists, counseling patients with rosacea.