Comparing comprehensibility of standard and enhanced prescription medicine labels: a randomized simulation.

OBJECTIVES: The objective of this study is to develop and user-test the comparative effectiveness of two enhanced label designs to improve comprehension of patients with low English proficiency versus a standard label representative of the pharmacist-affixed medicine labels currently used in practice. METHODS: Using a randomized two-group study design, 66 participants from Sydney, Australia were allocated to view a set of standard labels followed by a set of enhanced labels named 'linguistically enhanced labels' or 'linguistically and graphically enhanced labels'. Each set of labels depicted medicine directions of three levels of complexity, which participants viewed consecutively. The 'enhanced labels' incorporated several features documented in the literature as improving understanding of low-health-literate/linguistically compromised individuals such as translated directions in a language the person is more proficient in, numeric presentations of numbers/counts, carriage returns and graphic depiction of directions. A user-testing questionnaire relating to comprehensibility was conducted after each label was viewed. Differences in comprehensibility were assessed using a generalized linear model, Cochran-Mantel-Haenszel test for trend and a chi-square test. KEY FINDINGS: Results indicated significant improvements in comprehensibility with both types of enhanced labels compared with standard labels (P < 0.0001). The 'linguistically and graphically enhanced label' improved comprehensibility of the most complex directions to a greater extent than the 'linguistically enhanced label' (P < 0.0001). CONCLUSIONS: This study has highlighted the scope for improvement of existing pharmacist-affixed prescription medicine labels to ensure better understanding by individuals with low English proficiency. The enhanced labels trialled presented a means with which this may be achieved through the incorporation of key design elements, such as simpler, translated and graphically supported directions.

Association Between Conflicts of Interest and Authors' Positions on Harms of Varenicline: a Cross-Sectional Analysis.

BACKGROUND: Few studies have investigated the relationship between industry funding/conflicts of interest and authors' positions in opinion pieces on drug safety. Harmful effects of varenicline, a treatment for smoking cessation, have been highly contested. OBJECTIVE: To examine the association between pharmaceutical industry funding/authors' financial conflicts of interest and position on varenicline in opinion articles, especially in relation to the minimization of harms; to assess whether opinion pieces on drug safety issues written by authors with conflicts of interest are more frequently cited in the news or social media. DESIGN: Cross-sectional analysis. PARTICIPANTS: English language opinion pieces and narrative reviews about varenicline published between May 2006 and February 2019. MAIN MEASURES: Odds ratios and 95% confidence intervals; the Mann-Whitney two-sample statistic was used to test for differences in Altmetric scores, a measure of media attention. KEY RESULTS: Of the 221 included articles, 30.3% (67) disclosed the funding source and 62.9% (139) disclosed authors' conflicts of interest. Authors of opinion pieces on varenicline who reported financial ties to the pharmaceutical industry (as a conflict of interest or funding source) were more likely to minimise the cardiovascular and psychiatric risk of varenicline compared to those without conflicts of interest or industry funding (OR: 4.00; 95% CI: 1.32 to 12.16 for cardiovascular risk; OR: 8.51; 95% CI: 3.79 to 19.11 for psychiatric risk). These associations persisted in sensitivity analyses. No statistically significant difference in Altmetric score was found between articles with (mean 15.83, median 3) and without (mean 11.90, median 1) conflicts of interest, indicating similar media attention (p-value=0.11). CONCLUSIONS: We found that authors with financial ties to drug companies were more likely to publish opinion pieces that minimised harms of varenicline. These results raise questions about journals' editorial policies to accept reviews of treatments from authors with financial relationships with manufacturers.

Pharmacists' experiences serving culturally and linguistically diverse patients in the Australian community pharmacy setting.

Background There has been no in depth published study to date reporting on community pharmacists' current experiences and their future practice needs relating to providing culturally competent pharmaceutical care to Australian culturally and linguistically diverse patients with low English proficiency. Objective To explore community pharmacists' experiences serving culturally and linguistically diverse patients who have low English proficiency. Setting Community pharmacists in Australia. Method Focus group discussions with practising community pharmacists were conducted. Participants were recruited from metropolitan Sydney. Discussion centred around their current experiences and practice changes needed to enhance the provision of culturally competent pharmaceutical care. Thematic analysis using the constant comparison method within a grounded theory approach was performed on the data collected. Main outcome measure Participants' experiences in providing culturally competent care to culturally and linguistically diverse patients with low English proficiency. Results Thirty community pharmacists participated in six focus group discussions. Inadequate provision of culturally competent care was found to be primarily due to the issue of language incongruence between pharmacist and patient. Participants proposed various means with which such care may be provided to ensure patient safety. Conclusion Pharmacist participants expressed being inadequately equipped to provide culturally competent care in the community setting and identified potential means by which such care may be delivered. Addressing identified barriers that hinder community pharmacists' capacity to engage in culturally competent practice can potentially improve provision of pharmaceutical care to culturally and linguistically diverse patients with low English proficiency.

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies.

Information on rare adverse effects is often limited when a medication is initially approved for marketing. Medicines regulators use safety advisories to warn health professionals and consumers about emerging harms. This study aimed to identify characteristics and advice provided in cardiac safety advisories released by regulators in Australia, Canada, the United Kingdom, and the United States. This was a retrospective study of safety advisories about cardiac-related adverse events issued by these four international medicines regulators between 2010 and 2016. A descriptive overview was followed by a more detailed content analysis, focusing on recommended actions for health professionals, including monitoring advice. For the latter, we applied the systematic information for monitoring (SIM) scale to assess adequacy. Over this period, 164 safety advisories about cardiac harms were issued by the four regulators. There were 61 drugs with advisories of cardiac risk, only 9 (14.7%) of which had advisories from all regulators in countries where the drug was approved. The most common adverse events were cardiac arrhythmias (n = 97, 59.1%) and coronary artery disorders (n = 39, 23.8%). The most frequent advice to prescribers was to monitor patients (n = 74, 45.1%), although only 41.2% of these advisories provided detailed advice on how monitoring should occur. We found many differences in the decision to warn and the advice provided. Patient monitoring was most often recommended, but key information such as frequency or thresholds for action was often lacking. Healthcare professionals and consumers need consistent information about rare serious harms so that they can make informed decisions.

Media coverage of drug regulatory agencies' safety advisories: A case study of citalopram and denosumab.

AIMS: Drug regulators issue safety advisories to warn clinicians and the public about new evidence of harmful effects of medicines. It is unclear how often these messages are covered by the media. Our aim was to analyse the extent of media coverage of two medicines that were subject to safety advisories from 2007 to 2016 in Australia, Canada, the United Kingdom and the United States. METHODS: Two medicines widely used to treat mental health or physical conditions were selected: citalopram and denosumab. Media reports were identified by searching LexisNexis and Factiva. Reports were included if they stated at least one health benefit or harm. A content analysis of the reports was conducted. RESULTS: In total, 195 media reports on citalopram and 239 on denosumab were included. For citalopram, 43.1% (84/195) of the reports mentioned benefits, 85.6% (167/195) mentioned harms and 9.7% (19/195) mentioned the harm described in the advisories (cardiac arrhythmia). For denosumab, 94.1% (225/239) of the reports mentioned benefits and 39.7% (95/239) mentioned harms. The harms described in the advisories were rarely mentioned: 10.9% (26/239) of the reports mentioned osteonecrosis and ≤5% mentioned any of the other harms (atypical fractures, hypocalcaemia, serious infections and dermatologic reactions). CONCLUSIONS: We found limited media coverage of the harms highlighted in safety advisories. Almost two-thirds of the media stories on denosumab did not include any information about harms, despite the many advisories during this time frame. Citalopram coverage covered harms more often but rarely mentioned cardiac arrhythmias. These findings raise questions about how to better ensure that regulatory risk communications reach the general public.

Exploring culturally and linguistically diverse consumer needs in relation to medicines use and health information within the pharmacy setting.

BACKGROUND: Low health literacy may result in adverse health outcomes for patients and is a problem faced by countries with multi-ethnic demography. For those of culturally and linguistically diverse (CALD) backgrounds, this problem can be compounded by language barriers such as low English proficiency (LEP). The pharmacy is often the last point of health-care provider contact before patients begin taking their medicines and the first point of care for minor ailments. There is a paucity of data exploring or establishing the needs of this population with respect to general medicine use/health information and pharmacist assistance. OBJECTIVE: This study aimed to investigate the needs of CALD Australians with low or negligible English proficiency, specifically in regards to their understanding of health and medicines and the role of pharmacy in achieving best medicine use outcomes for this population. METHODS: A qualitative method was employed. Semi-structured interviews were conducted with individuals of CALD backgrounds with a self-reported low or negligible English proficiency. The interviews explored past experiences with medicines use and interaction with health care professionals. A grounded theory approach with the method of constant comparison was undertaken for analyzing the data. Interviews were conducted until there was a saturation of themes. RESULTS: Thirty-one interviews were conducted, and data analyses identified themes relating to medicine use of CALD community members which were broadly categorized into: (1) health information, (2) interactions with health care professionals, (3) social networks and (4) perceptions and beliefs influencing health-related behavior. CONCLUSIONS: In CALD communities there are significant barriers to patient understanding and optimal use of medicines. There is significant potential for pharmacy to facilitate in addressing these issues as currently pharmacy is largely playing the role of dispenser of medicines. Whilst timely access of medicines is being ensured, there seems to be ample room for improvement in terms of pharmacy's role in facilitating appropriate and efficacious use of medicines with such CALD community members.

Fitness to practise in pharmacy: a study of impairment in professional practice.

OBJECTIVE: To explore the opinions and knowledge of Australian pharmacists about impairment in the profession, and their awareness of new legislation regarding impairment and mandatory reporting. SETTING: Pharmacy practice in Australia. METHOD: Pharmacists' opinions and knowledge were explored using a purposively designed, de-identified survey distributed by an intermediate mailing house to randomly selected pharmacists registered with the Pharmacy Board. Descriptive statistics and thematic analyses were conducted on the data. KEY OUTCOME MEASURES: This being an explorative study, we analysed various items using standard statistical methods and qualitative thematic analysis for responses to open-ended questions. RESULTS: Responses from 370 registered pharmacists were obtained. Of these, nearly 60% were not confident in their knowledge of legislation relating to impairment. The vast majority stated they would consider reporting an impaired colleague in principle, but only after consulting the colleague. Older pharmacists demonstrated increased awareness of new legislation; this was accompanied however, by a marked decrease in confidence regarding knowledge about impairment. Thematic analysis of the qualitative data revealed four main themes: (1) perception of impairment and support systems available (2) stigma related to implications of impairment and whistle-blowing (3) factors affecting reporting of impairment and (4) management of impairment. CONCLUSION: Australian pharmacists in this study recognised the importance of the issue of impairment, but appeared to lack confidence and/or awareness of legislative requirements regarding impairment in the profession. There is a need for educative programs and accessible, profession-specific rehabilitative programs to be instigated for management of impairment in the profession of pharmacy in Australia.