Australian pharmacists' understanding of their continuing professional development obligations

Background: Adoption of mandatory continuing professional development (CPD) for pharmacists in Australia is relatively new. Difficulties have been reported with the introduction of CPD frameworks in other countries. There is limited information on how Australian pharmacists have engaged with the CPD requirements for registration. Aim: To explore Australian pharmacists' understanding and engagement with the CPD requirements for renewal of registration. Method: The Pharmacy Board of Australia's CPD requirements for registration was used to design an online survey to explore the level of understanding and engagement Australian pharmacists have with the CPD framework. Results: 278 pharmacists responded to the survey - 66% were female, 30% were male and 4% did not disclose their gender. 63% of respondents noted that it would not be difficult to acquire 40 CPD credits annually. Respondents identified that Group 1 activities were a preferred way of acquiring CPD credits. Majority of pharmacists (91%) believed that they knew the CPD requirements for registration and 77% noted that there had been sufficient guidance provided. Despite this, 26% of participants had never used self-directed learning plans and 38% did not know how to undertake self-directed learning. 76% of participants were under the common misconception that CPD is synonymous with continuing education. Conclusion: The majority of pharmacists believe they understand and can engage in the acquisition of CPD credits for renewal of registration. Some aspects of the CPD framework was not understood, such as how it aims to develop a pharmacist's practice. This aspect of the CPD framework will need to be further developed

Prevalence of swallowing difficulties and medication modification in customers of community pharmacists

BACKGROUND: People may alter their solid oral medication dosage forms to make it easier to swallow. However, modification of solid medication dosage forms can lead to undesirable effects, and people may alter the dosage forms without informing the health professionals involved in their care. AIM: To estimate the prevalence of swallowing difficulties and medication modification amongst community pharmacy consumers, and to investigate consumer views, attitudes, and interactions with health professionals regarding such issues. METHODS: Consumers were recruited from five community pharmacies in Brisbane, Queensland and invited to participate in a structured interview. RESULTS: A total of 369 consumers participated in the study. Overall, 16.5% of people reported experiencing swallowing difficulties, and 10.6% of all respondents reported modifying medication dosage forms. Almost half (44.2%) of those surveyed did not think there would be issues with modifying medication dosage forms. Some consumers would not seek advice from health professionals if they experienced swallowing problems and/or would not seek advice from health professionals before modifying their medication dosage forms, regardless of their thoughts about any problems associated with this practice. CONCLUSION: Some consumers appeared to be accustomed to modifying medication dosage forms, even when there was no apparent or obvious need. People were also reluctant to seek advice from health professionals regarding swallowing difficulties, or modifying medication dosage forms. Health professionals must be assertive in educating consumers about swallowing problems, and medication dosage form modification

Dosage form modification and oral drug delivery in older people

Many people cannot swallow whole tablets and capsules. The cause ranges from difficulties overriding the natural instinct to chew solids/foodstuff before swallowing, to a complex disorder of swallowing function affecting the ability to manage all food and fluid intake. Older people can experience swallowing difficulties because of co-morbidities, age-related physiological changes, and polypharmacy. To make medicines easier to swallow, many people will modify the medication dosage form e.g. split or crush tablets, and open capsules. Some of the challenges associated with administering medicines to older people, and issues with dosage form modification will be reviewed. Novel dosage forms in development are promising and may help overcome some of the issues. However, until these are more readily available, effective interdisciplinary teams, and improving patient health literacy will help reduce the risk of medication misadventures in older people

Nurse experiences of medication administration to people with swallowing difficulties living in aged care facilities: a systematic review of qualitative evidence

To identify nurses' experiences of administering oral medications to residents of aged care facilities (ACFs) with swallowing difficulties.Administering medicines to older people with swallowing difficulties is a challenging task. Nurses frequently modify oral medications e.g. by crushing/splitting tablets or opening capsules, to facilitate the administration process. These practices are associated with an increased risk of medication administration errors. However, the reasons for these practices from the nurse's perspective are not well understood.The review investigated studies on the experiences of nurses of any level with the responsibility of medication administration in ACFs in terms of problems and challenges they encountered when administering oral medicines to aged care residents with swallowing difficulties. Aged care facilities providing all levels of care were considered for inclusion. Qualitative studies including, but not limited to, phenomenology, grounded theory, ethnography and action research designs as well as mixed methods studies and text and opinion papers were considered.A comprehensive database search of PubMed, CINAHL, Embase and Scopus was conducted between October and December 2016. MedNar and ProQuest Dissertations and Theses were used to search for gray literature. No date limitation was applied. The Joanna Briggs Institute Qualitative Assessment and Review Instrument critical appraisal tool (JBI-QARI) was used to assess the quality of the papers. The JBI-QARI data extraction instrument was used to extract qualitative findings. Data synthesis was not applicable in the final analysis due to the inclusion of only one article.The initial search resulted in 1681 unique titles for screening. A total of 202 abstracts were screened, after which a full-text review conducted for 19 articles. After the full-text review, only one article was eligible to be included in the final report. The included study scored highly in terms of methodological quality. The findings highlighted issues around time constraints, complexity of medication administration process to residents of ACFs with swallowing difficulties, cost and resources for alternative strategies, inefficient information flow and communication among healthcare professionals, and nurses' knowledge and training needs.The limited findings of this systematic review indicate that further research is necessary to provide evidence of nurses' experiences with regards to administering oral medications to older people with swallowing difficulties living in ACFs. A comprehensive understanding of these experiences may lead to organizational system changes to support nurses and older people with swallowing difficulties in ACFs

The safety assessment of tampons: illustration of a comprehensive approach for four different products

IntroductionWe illustrate a comprehensive tampon safety assessment approach that assures products can be used safely. Material biocompatibility, vaginal mucosa assessment, vaginal microbiome evaluation, and in vitro assessment of potential risk of staphylococcal toxic shock syndrome expressed through growth of Staphylococcus aureus (S. aureus) and production of TSST-1 are the four essential portions of the approach. Post-marketing surveillance informs of possible health effects that warrant follow up. The approach meets or exceeds US and international regulatory guidance and is described through the example of four tampon products.Methods/ResultsEach product is comprised mostly of large molecular weight components (cotton, rayon, polymers) that cannot pass the vaginal mucosa, are widely used across the industry, and replete with a vast body of safety data and a long history of safe use in the category. Quantitative risk assessment of all small molecular weight components assured a sufficient margin of safety supporting their use. Vaginal mucosa assessment confirmed that pressure points, rough edges and/or sharp contact points were absent. A randomized cross-over clinical trial (ClinicalTrials.gov Identifier: NCT03478371) revealed favorable comfort ratings, and few complaints of irritation, burning, stinging, or discomfort upon insertion, wear, and removal. Adverse events were few, mild in severity, self-limited and resolved without treatment. Vaginal microbiota assessment in vitro presented no adverse effect on microbial growth. Culture-independent microbiome analyses from vaginal swab samples obtained during the clinical trial showed no differences attributable to tampon usage, but instead due to statistically significant subject-to-subject variability. Growth of S. aureus and TSST-1 toxin production in the presence of any of the four products in vitro were statistically significantly reduced when compared to medium control alone.DiscussionThe data from the four elements of the comprehensive safety assessment approach illustrated herein confirm that tampons evaluated using this system can be used safely for menstrual protection. A post-marketing surveillance system that monitors and responds to in-market experiences indicated in-use tolerability of the product among consumers, thus confirming the conclusions of the pre-marketing safety assessment

Exploration of change in persistence patterns of opioid use among patients with non-cancer and cancer pain over a three-year follow-up period

Background: Little is known about the different patterns of persistent opioid use and whether the patterns of clinical opioid use remain the same throughout the long-term opioid therapy. Aim: This study explores the different patterns of persistent opioid use and the change in these patterns over time in patients with non-cancer and cancer pain. Method: This retrospective cross-sectional study included patients with non-cancer and cancer pain receiving opioid prescriptions during 2013-2015 at outpatient tertiary hospital settings in Malaysia. A three-dimensional persistence measure consisting of treatment intensity, frequency and distribution were used to define persistent opioid users as wide (use opioids most of the days in a year), intermediate (use opioids daily) or strict (use opioids continuously to achieve a therapeutic concentration) users. The number of patients in each persistence definition and the change in persistence patterns over time was recorded. Results: Majority of persistent opioid users in the non-cancer and cancer groups were in the wide (9.3% vs.4.8%), followed by intermediate (3.1% vs.0.5%), and strict (1.8% vs.0.9%) definitions. Over a three-year study duration, change to a less stringent persistence definition was observed in the non-cancer group whereas no discernible pattern of change was observed in the cancer group. Conclusion: Change in the patterns of clinical opioid use over time was detected among persistent opioid users in both non-cancer and cancer groups using a three-dimensional persistence measure. This measure which is sensitive to the changes in clinical use of opioids over time can greatly impact future research and practices for better pain management involving opioids

Estimating the Impact of Adding C-Reactive Protein as a Criterion for Lipid Lowering Treatment in the United States

BACKGROUND: There is growing interest in using C-reactive protein (CRP) levels to help select patients for lipid lowering therapy—although this practice is not yet supported by evidence of benefit in a randomized trial. OBJECTIVE: To estimate the number of Americans potentially affected if a CRP criteria were adopted as an additional indication for lipid lowering therapy. To provide context, we also determined how well current lipid lowering guidelines are being implemented. METHODS: We analyzed nationally representative data to determine how many Americans age 35 and older meet current National Cholesterol Education Program (NCEP) treatment criteria (a combination of risk factors and their Framingham risk score). We then determined how many of the remaining individuals would meet criteria for treatment using 2 different CRP-based strategies: (1) narrow: treat individuals at intermediate risk (i.e., 2 or more risk factors and an estimated 10–20% risk of coronary artery disease over the next 10 years) with CRP > 3 mg/L and (2) broad: treat all individuals with CRP > 3 mg/L. DATA SOURCE: Analyses are based on the 2,778 individuals participating in the 1999–2002 National Health and Nutrition Examination Survey with complete data on cardiac risk factors, fasting lipid levels, CRP, and use of lipid lowering agents. MAIN MEASURES: The estimated number and proportion of American adults meeting NCEP criteria who take lipid-lowering drugs, and the additional number who would be eligible based on CRP testing. RESULTS: About 53 of the 153 million Americans aged 35 and older meet current NCEP criteria (that do not involve CRP) for lipid-lowering treatment. Sixty-five percent, however, are not currently being treated, even among those at highest risk (i.e., patients with established heart disease or its risk equivalent)—62% are untreated. Adopting the narrow and broad CRP strategies would make an additional 2.1 and 25.3 million Americans eligible for treatment, respectively. The latter strategy would make over half the adults age 35 and older eligible for lipid-lowering therapy, with most of the additionally eligible (57%) coming from the lowest NCEP heart risk category (i.e., 0–1 risk factors). CONCLUSION: There is substantial underuse of lipid lowering therapy for American adults at high risk for coronary disease. Rather than adopting CRP-based strategies, which would make millions more lower risk patients eligible for treatment (and for whom treatment benefit has not yet been demonstrated in a randomized trial), we should ensure the treatment of currently defined high-risk patients for whom the benefit of therapy is established

A Genetic Association Study of Serum Acute-Phase C-Reactive Protein Levels in Rheumatoid Arthritis: Implications for Clinical Interpretation

A genetic association study by Timothy Vyse and colleagues suggests that there is a significant association between CRP variants and acute-phase serum CRP concentrations in patients with rheumatoid arthritis, including those with chronic inflammation