Adverse drug reactions in South African patients receiving bedaquiline-containing tuberculosis treatment: an evaluation of spontaneously reported cases.

BACKGROUND: Bedaquiline was recently introduced into World Health Organization (WHO)-recommended regimens for treatment of drug resistant tuberculosis. There is limited data on the long-term safety of bedaquiline. Because bedaquiline prolongs the QT interval, there are concerns regarding cardiovascular safety. The Western Cape Province in South Africa has an established pharmacovigilance programme: a targeted spontaneous reporting system which solicits reports of suspected adverse drug reactions (ADRs) in patients with HIV-1 and/or tuberculosis infection. Since 2015, bedaquiline has been included in the treatment regimens recommended for resistant tuberculosis in South Africa. We describe ADRs in patients on bedaquiline-containing tuberculosis treatment that were reported to the Western Cape Pharmacovigilance programme. METHODS: We reviewed reports of suspected ADRs and deaths received between March 2015 and June 2016 involving patients receiving bedaquiline-containing tuberculosis treatment. A multidisciplinary panel assessed causality, and categorised suspected ADRs using World Health Organisation-Uppsala Monitoring Centre system categories. "Confirmed ADRs" included all ADRs categorised as definite, probable or possible. Preventability was assessed using Schumock and Thornton criteria. Where a confirmed ADR occurred in a patient who died, the panel categorised the extent to which the ADR contributed to the patient's death as follows: major contributor, contributor or non-contributor. RESULTS: Thirty-five suspected ADRs were reported in 32 patients, including 13 deaths. There were 30 confirmed ADRs, of which 23 were classified as "possible" and seven as "probable". Bedaquiline was implicated in 22 confirmed ADRs in 22 patients. The most common confirmed ADR in patients receiving bedaquiline was QT prolongation (8 cases, 7 of which were severe). A fatal arrhythmia was suspected in 4 sudden deaths. These 4 patients were all taking bedaquiline together with other QT-prolonging drugs. There were 8 non-bedaquiline-associated ADRs, of which 7 contributed to deaths. CONCLUSIONS: Confirmed ADRs in patients receiving bedaquiline reflect the known safety profile of bedaquiline. Quantifying the incidence and clinical consequences of severe QT-prolongation in patients receiving bedaquiline-containing regimens is a research priority to inform recommendations for patient monitoring in treatment programmes for drug resistant tuberculosis. Pharmacovigilance systems within tuberculosis treatment programmes should be supported and encouraged, to provide ongoing monitoring of treatment-limiting drug toxicity.

Best practice guidelines on publishing ethics: a publisher's perspective, 2nd edition.

Wiley has updated its publishing ethics guidelines, first published in 2006. The new guidelines provide guidance, resources, and practical advice on ethical concerns that arise in academic publishing for editors, authors, and researchers, among other audiences. New guidance is also included on whistle blowers, animal research, clinical research, and clinical trial registration, addressing cultural differences, human rights, and confidentiality. The guidelines are uniquely interdisciplinary, and were reviewed by 24 editors and experts chosen from the wide range of communities that Wiley serves. They are also published in Advanced Materials, International Journal of Clinical Practice, Annals of the New York Academy of Sciences, Social Science Quarterly, and on the website http://exchanges.wiley.com/ethicsguidelines.

Management of Type 2 Diabetes Mellitus and Kidney Failure in People with HIV-Infection in Africa: Current Status and a Call to Action.

There is an increasing global burden of diabetes mellitus (DM) and chronic kidney disease (CKD), coupled with a high burden of people with HIV (PWH). Due to an increased lifespan on ART, PWH are now at risk of developing non-communicable diseases, including DM. Africa has the greatest burden of HIV infection and will experience the greatest increase in prevalence of DM over the next two decades. In addition, there is a rising number of people with CKD and progression to kidney failure. Therefore, there is an urgent need for the early identification and management of all 3 diseases to prevent disease progression and complications. This is particularly important in Africa for people with CKD where there is restricted or no access to dialysis and/or transplantation. This review focuses on the epidemiology and pathophysiology of the interaction between HIV infection and DM and the impact that these diseases have on the development and progression of CKD. Finally, it also aims to review the data on the management, which stems from the growing burden of all three diseases.

Devastatingly human: an analysis of registered nurses' medication error accounts.

Despite many safeguards, nurses make the majority of medication administration errors. The purpose of our research was to investigate the perceived causes for such errors and to better understand how nurses deal with them. We performed an interpretive analysis of 158 accounts by nurses who made self-identified medication errors. We found common themes among these accounts. First, although nurses admitted responsibility for errors, they simultaneously identified a variety of external contributing factors. Second, nurses' accounts were often framed in terms of "being new," with the underlying background expectancy of inexperience. Third, emotionally devastating visceral responses to errors were common and often incongruent with error severity. Fourth, nurses had to deal with fear. Fifth, nurses voiced frustrations with technologies and regulations. Sixth, embedded within many of the accounts was a "lessons learned" theme, through which nurses developed "personal rules" as a result of an error. We conclude with suggestions for additional research.

When the 5 rights go wrong: medication errors from the nursing perspective.

This study describes nurses' perceptions about how and why medication errors occur and their personal experiences with medication errors. A survey was mailed to a random sample of registered nurses. Two hundred and two responded. Of those, 158 (78%) nurses admitted making medication errors and provided details about these errors. This study, by providing the perspective of frontline nurses, contributes to the body of knowledge on medication errors.

Developing critical thinking in the perioperative environment.

Critical thinking is considered an essential skill for nurses by many, including major accrediting agencies, health care administrators, and AORN. This is in part because of the environment in which nurses function. Health care, medicine, technology, and nursing are dynamic and constantly changing. The perioperative environment is complex, fast paced, unique, and oftentimes unpredictable. Critical thinking skills enable perioperative nurses to function effectively and evolve in this ever-changing environment. Nursing education programs are mandated to teach critical thinking skills. It is the practice arena, however, that refines, hones, and grows these skills. This article provides an overview of critical thinking in the context of nursing, as well as strategies and interventions designed to teach critical thinking skills.

Use of Clinical Faculty Input in Development of an Error and Near-Miss Reporting Form.

BACKGROUND: Nonreporting of medical errors is an impediment to error prevention and safety in the clinical environment. Many prelicensure nursing education programs do not have policies, procedures, or forms to support student reporting of errors or near misses during their clinical experiences. PURPOSE: The purpose of this study was to describe the experiences of clinical faculty with prelicensure nursing student errors or near misses in the clinical environment and to use this information to create a reporting form. METHODS: Focus groups were used to obtain information about the experiences of clinical faculty (n = 28) with errors or near misses of students. RESULTS: Clinical faculty reported students having safety issues with medication administration, being too task oriented, and modeling shortcut behaviors they had witnessed in clinical practice rather than performing skills as they had learned them. Using information obtained, a clinical error and near-miss reporting form was developed. CONCLUSIONS: This form has the potential to increase patient safety in the clinical environment by improving reporting.

More Than 1 Million Potential Second Victims: How Many Could Nursing Education Prevent?

Any error made in health care can cause the health care provider to become a second victim. There are many initiatives, tools, and instruments designed to support second victims after an error has been made. The role that nursing education can play in preventing nurses from becoming second victims has not been well explored. This article presents a study designed to investigate perceptions of recent BSN graduates about preparation for medication administration, medication error, and their personal experience with error making and second victimhood.

Nurses' rights of medication administration: Including authority with accountability and responsibility.

Medication errors continue to occur too frequently in the United States. Although the five rights of medication administration have expanded to include several others, evidence that the number of errors has decreased is missing. This study suggests that medication rights for nurses as they administer medications are needed. The historical marginalization of the voice of nurses has been perpetuated with detrimental impacts to nurses and patients. In recent years, a focus on the creation of a just culture, with a balance of accountability and responsibility, has sought to bring a fairer and safer construct to the healthcare environment. This paper proposes that in order for a truly just culture to exist, the balance must also include nurses' authority. Only when a triumvirate of responsibility, accountability, and authority exists can an environment that supports reduced medication errors flourish. Through identification and implementation of Nurses Rights of Medication Administration, nurses' authority to control the administration process is both formalized and legitimized. Further study is needed to identify these rights and how to fully implement them.

After the Medication Error: Recent Nursing Graduates' Reflections on Adequacy of Education.

BACKGROUND: The purpose of this study was to better understand individual- and system-level factors surrounding making a medication error from the perspective of recent Bachelor of Science in Nursing graduates. METHOD: Online survey mixed-methods items included perceptions of adequacy of preparatory nursing education, contributory variables, emotional responses, and treatment by employer following the error. RESULTS: Of the 168 respondents, 55% had made a medication error. Errors resulted from inexperience, rushing, technology, staffing, and patient acuity. Twenty-four percent did not report their errors. Key themes for improving education included more practice in varied clinical areas, intensive pharmacological preparation, practical instruction in functioning within the health care environment, and coping after making medication errors. CONCLUSION: Errors generally caused emotional distress in the error maker. Overall, perceived treatment after the error reflected supportive environments, where nurses were generally treated with respect, fair treatment, and understanding. Opportunities for nursing education include second victim awareness and reinforcing professional practice standards. [J Nurs Educ. 2018;57(5):275-280.].

Making an Infusion Error: The Second Victims of Infusion Therapy-Related Medication Errors.

Infusion therapy-related adverse events can result in distress and professional suffering for the nurse involved with the event, with long-lasting consequences. This article discusses the second victim syndrome and its impacts on nurses. Original research on 168 recent nursing graduates and their experiences with second victim syndrome after making an infusion-related error is also presented. The article concludes with strategies to help nurses cope with the aftermath of making an infusion therapy-related medication error.

Adverse Drug Reactions Reported to a National HIV & Tuberculosis Health Care Worker Hotline in South Africa: Description and Prospective Follow-Up of Reports.

INTRODUCTION: The National HIV & Tuberculosis Health Care Worker (HCW) Hotline provides advice on the management of suspected adverse drug reactions (ADRs). We describe suspected ADRs reported to the hotline by HCWs, concordance with advice, and patient outcomes. METHODS: We reviewed suspected ADRs in HIV-infected patients, patients taking antiretrovirals and patients taking anti-tuberculosis therapy reported from May 2013 to October 2014. We performed causality assessment using the World Health Organization Uppsala Monitoring Centre (WHO-UMC) criteria. We included suspected ADRs categorized as certain, probable or possible in further analysis. RESULTS: We received 772 ADR reports, of which 87/772 (11.3%) were classified as certain, 176/772 (22.8%) as probable, 361/772 (46.8%) as possible, and 148/772 (19.2%) as unlikely or unassessable. The most frequent ADRs were rash, drug-induced liver injury (DILI) and kidney injury, comprising 110/624 (17.6%), 87/624 (13.9%), and 77/624 (12.3%), respectively. The ADR was severe in 27.3% of rashes, 36.4% of kidney injury reports and 88.5% of DILI reports. Most frequently implicated drugs, either alone or in combination with other potentially causative drugs, were efavirenz (rashes), efavirenz and anti-tuberculosis drugs (DILI) and tenofovir (kidney injury). In 383 cases with HCW follow-up, 254 (66.3%) improved, 9 (2.3%) had complete resolution, 32 (8.4%) remained unchanged, 6 (1.6%) deteriorated, 10 (2.6%) died and 72 (18.8%) had unknown outcome. Advice provided was followed in 93.2% of these cases. Of 223 ADRs with preventability data, 40 (17.9%) were preventable. CONCLUSION: Queries about rashes, DILIs and kidney injuries were common. Detection and management of these ADRs should be included in HCW training. In cases with follow-up, concordance with advice was high, and HCWs reported improvement in the majority.

Implementation of Mock Competency Skill Assessments to Improve Student Outcomes.

A primary responsibility for nurse educators is to provide students with theoretical knowledge and clinical skills for professional nursing. In this study, laboratory faculty developed a creative pedagogical strategy to reduce nursing student stress during assessment of skill performance. Mock competencies were structured so that students participated in peer-to-peer evaluations in simulated competency assessments. The purpose of this study was to determine whether this pedagogical strategy had an impact on first-round pass rates for skills competency assessments.

Best practice guidelines on publishing ethics: a publisher's perspective, 2nd edition.

Wiley has updated its publishing ethics guidelines, first published in 2006. These new guidelines provide guidance, resources, and practical advice on ethical concerns that arise in academic publishing for editors, authors, and researchers, among other audiences. New guidance is included about whistle blowers, animal research, clinical research, and clinical trial registration, addressing cultural differences, human rights, and confidentiality. The guidelines are uniquely interdisciplinary, and were reviewed by 24 editors and experts chosen from the wide range of communities that Wiley serves. These guidelines are also published in: Headache, International Journal of Clinical Practice, Annals of the New York Academy of Sciences, Social Science Quarterly, and on the website http://exchanges.wiley.com/ethicsguidelines.

Oral hygiene behaviors and caries experience in Northwest PRECEDENT patients.

OBJECTIVES: To investigate the association between oral hygiene behaviors (toothbrushing, water rinsing after brushing, interproximal cleaning, and adjunctive use of fluoride products) and recent caries (past 24 months) in a random sample of patients in Northwest PRECEDENT practices. METHODS: Practitioner-members of Northwest PRECEDENT, a dental practice-based research network, conducted a longitudinal study on caries risk assessment. At baseline, patients completed a questionnaire on oral self-care, snacking, health, and socio-demographics. A dental examination recorded readily visible heavy plaque and decayed, missing, and filled teeth; chart review captured new caries and treatments in the previous 24 months. Bivariate and multiple generalized estimating equations (GEE) log-linear regression models stratified by age-groups were used to relate oral hygiene behaviors to the primary outcome of mean dental caries in the past 24 months on data from 1400 patients in 63 practices. The primary exposure of interest was fluoride toothbrushing frequency. RESULTS: Fluoride toothbrushing once per day or twice or more per day by patients 9-17 was significantly associated with a 50% lower mean caries rate compared with fluoride toothbrushing less than once per day, after adjustment for covariates [rate ratios (RR) = 0.5; 95% confidence intervals (CI) = 0.3-0.8]. After adjustment, for patients 18-64, fluoride toothbrushing two or more times per day was significantly associated with a 40% lower recent mean caries rate (RR = 0.6; 95% CI = 0.4-0.9); in patients 65+, twice a day or more fluoride toothbrushing was not associated with lower caries rates (RR = 1.1; 95% CI = 0.7-1.8). Of the other oral hygiene variables, after adjustment, patients 18-64 who rinsed with water after brushing had a 40% lower mean caries rate compared with no rinsing (RR = 0.6; 95% CI = 0.4-0.9) and the presence of readily visible heavy plaque was significantly associated with an increase in the mean caries rate for patients 18-64 (RR = 1.6; 95% CI = 1.2-2.2) and 65+ (RR = 2.5; 95% CI = 1.8-3.5). CONCLUSIONS: In the present study, the frequency of fluoride toothbrushing and the presence of readily visible heavy plaque were the factors most strongly associated with mean caries rate. In young patients with permanent dentition, the daily application of fluoride toothpaste appears more important than emphasis on thorough plaque removal. While for adults, the protective effect of twice daily fluoride toothbrushing disappears with advancing age and the presence of readily visible heavy plaque becomes increasingly associated with caries risk.

Best practice guidelines on publishing ethics: a publisher's perspective, 2nd edition.

Wiley has updated its publishing ethics guidelines, first published in 2006. The new guidelines provide guidance, resources, and practical advice on ethical concerns that arise in academic publishing for editors, authors, and researchers, among other audiences. New guidance is also included on whistle blowers, animal research, clinical research, and clinical trial registration, addressing cultural differences, human rights, and confidentiality. The guidelines are uniquely interdisciplinary and were reviewed by 24 editors and experts chosen from the wide range of communities that Wiley serves. The new guidelines are also published in Advanced Materials, Headache, International Journal of Clinical Practice, Social Science Quarterly, and on the website http://exchanges.wiley.com/ethicsguidelines.