Detecting Medication Risks among People in Need of Care: Performance of Six Instruments.

INTRODUCTION: Numerous tools exist to detect potentially inappropriate medication (PIM) and potential prescribing omissions (PPO) in older people, but it remains unclear which tools may be most relevant in which setting. OBJECTIVES: This cross sectional study compares six validated tools in terms of PIM and PPO detection. METHODS: We examined the PIM/PPO prevalence for all tools combined and the sensitivity of each tool. The pairwise agreement between tools was determined using Cohen's Kappa. RESULTS: We included 226 patients in need of care (median (IQR age 84 (80-89)). The overall PIM prevalence was 91.6 (95% CI, 87.2-94.9)% and the overall PPO prevalence was 63.7 (57.1-69.9%)%. The detected PIM prevalence ranged from 76.5%, for FORTA-C/D, to 6.6% for anticholinergic drugs (German-ACB). The PPO prevalences for START (63.7%) and FORTA-A (62.8%) were similar. The pairwise agreement between tools was poor to moderate. The sensitivity of PIM detection was highest for FORTA-C/D (55.1%), and increased to 79.2% when distinct items from STOPP were added. CONCLUSION: Using a single screening tool may not have sufficient sensitivity to detect PIMs and PPOs. Further research is required to optimize the composition of PIM and PPO tools in different settings.

Enhancing the quality of prescribing practices for older adults discharged from the emergency department in Rhode Island.

BACKGROUND: We sought to examine the effectiveness of the Enhancing the Quality of Prescribing Practices for Older Adults Discharged from the Emergency Department (EQUiPPED) medication safety program in three emergency departments (EDs) within the largest health system in Rhode Island (RI) with funding through a quality incentive payment by a private insurance partner. METHODS: This study utilized a quasi-experimental interrupted time series design to implement EQUiPPED, a three-prong intervention aimed at reducing potentially inappropriate medication (PIM) prescriptions to 5% or less per month. We included clinicians who prescribed medications to older ED patients during the pre-and post-intervention periods from July 2018 to January 2021. We determined the monthly rate of PIM prescribing among older adults discharged from the ED, according to the American Geriatrics Society Beers Criteria, using Poisson regression. RESULTS: 247 ED clinicians (48% attendings [n = 119], 27% residents [n = 67], 25% advanced practice providers [n = 61]) were included in EQUiPPED, of which 92% prescribed a PIM during the study period. In the pre-implementation period (July 2018-July 2019) the average monthly rate of PIM prescribing was 9.30% (95% CI: 8.82%, 9.78%). In the post-implementation period (October 2019-January 2021) the PIM prescribing rate decreased significantly to 8.62% (95% CI: 8.14%, 9.10%, p < 0.01). During pre-implementation, 1325 of the 14,193 prescribed medications were considered inappropriate, while only 1108 of the 13,213 prescribed medications in post-implementation were considered inappropriate. The greatest reduction was observed among antihistamines, skeletal muscle relaxants, and benzodiazepines. CONCLUSIONS: EQUiPPED contributed to a modest improvement in PIM prescribing to older adults among clinicians in these RI EDs even in the midst of the COVID-19 pandemic. The quality incentive funding model demonstrates a successful strategy for implementation and, with greater replication, could shape national policy regarding health care delivery and quality of care for older adults.

A multimodal intervention to optimise antimicrobial use in residential aged care facilities (ENGAGEMENT): protocol for a stepped-wedge cluster randomised trial.

BACKGROUND: Inappropriate antibiotic use can cause harm and promote antimicrobial resistance, which has been declared a major health challenge by the World Health Organization. In Australian residential aged care facilities (RACFs), the most common indications for antibiotic prescribing are for infections of the urinary tract, respiratory tract and skin and soft tissue. Studies indicate that a high proportion of these prescriptions are non-compliant with best prescribing guidelines. To date, a variety of interventions have been reported to address inappropriate prescribing and overuse of antibiotics but with mixed outcomes. This study aims to identify the impact of a set of sustainable, multimodal interventions in residential aged care targeting three common infection types. METHODS: This protocol details a 20-month stepped-wedge cluster-randomised trial conducted across 18 RACFs (as 18 clusters). A multimodal multi-disciplinary set of interventions, the 'AMS ENGAGEMENT bundle', will be tailored to meet the identified needs of participating RACFs. The key elements of the intervention bundle include education for nurses and general practitioners, telehealth support and formation of an antimicrobial stewardship team in each facility. Prior to the randomised sequential introduction of the intervention, each site will act as its own control in relation to usual care processes for antibiotic use and stewardship. The primary outcome for this study will be antibiotic consumption measured using defined daily doses (DDDs). Cluster-level rates will be calculated using total occupied bed numbers within each RACF during the observation period as the denominator. Results will be expressed as rates per 1000 occupied bed days. An economic analysis will be conducted to compare the costs associated with the intervention to that of usual care. A comprehensive process evaluation will be conducted using the REAIM Framework, to enable learnings from the trial to inform sustainable improvements in this field. DISCUSSION: A structured AMS model of care, incorporating targeted interventions to optimise antimicrobial use in the RACF setting, is urgently needed and will be delivered by our trial. The trial will aim to empower clinicians, residents and families by providing a robust AMS programme to improve antibiotic-related health outcomes. TRIAL REGISTRATION: US National Library of Medicine Clinical Trials.gov ( NCT04705259 ). Prospectively registered in 12th of January 2021.

Cluster randomised controlled trial to assess a tailored intervention to reduce antibiotic prescribing in rural China: study protocol.

INTRODUCTION: Up to 80% of patients with respiratory tract infections (RTI) attending healthcare facilities in rural areas of China are prescribed antibiotics, many of which are unnecessary. Since 2009, China has implemented several policies to try to reduce inappropriate antibiotic use; however, antibiotic prescribing remains high in rural health facilities. METHODS AND ANALYSIS: A cluster randomised controlled trial will be carried out to estimate the effectiveness and cost effectiveness of a complex intervention in reducing antibiotic prescribing at township health centres in Anhui Province, China. 40 Township health centres will be randomised at a 1:1 ratio to the intervention or usual care arms. In the intervention group, practitioners will receive an intervention comprising: (1) training to support appropriate antibiotic prescribing for RTI, (2) a computer-based treatment decision support system, (3) virtual peer support, (4) a leaflet for patients and (5) a letter of commitment to optimise antibiotic use to display in their clinic. The primary outcome is the percentage of antibiotics (intravenous and oral) prescribed for RTI patients. Secondary outcomes include patient symptom severity and duration, recovery status, satisfaction, antibiotic consumption. A full economic evaluation will be conducted within the trial period. Costs and savings for both clinics and patients will be considered and quality of life will be measured by EuroQoL (EQ-5D-5L). A qualitative process evaluation will explore practitioner and patient views and experiences of trial processes, intervention fidelity and acceptability, and barriers and facilitators to implementation. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Biomedical Research Ethics Committee of Anhui Medical University (Ref: 20180259); the study has undergone due diligence checks and is registered at the University of Bristol (Ref: 2020-3137). Research findings will be disseminated to stakeholders through conferences and peer-reviewed journals in China, the UK and internationally. TRIAL REGISTRATION NUMBER: ISRCTN30652037.

Telemedication Reviews to Optimize Medication Prescription for Older People in Nursing Homes.

Introduction: Older people living in nursing homes (NH) are at a higher risk of preventable drug-related adverse events because of age-related physiological changes, polypathology, and polypharmacy. NH residents are particularly exposed to potentially inappropriate medications (PIMs). Many strategies have been developed to improve the quality and the safety of drug prescription in NH, including medication reviews (MRs). Methods: In the context of the application of telemedicine, we developed and are currently implementing a novel hospital expert-based MRs through tele-expertise (or "telemedication review," telemedication reviews hereafter [TMR]) in French NH residents. The impact of these TMR on unplanned hospitalizations 3 months after implementation is assessed. TMR consider all available sociodemographic, clinical, biological, and pharmaceutical data pertaining to the patient and are performed in accordance with their health care objectives. Results: The preliminary results for the 39 TMRs performed to date (September 2021) showed that a total of 402 PIMs were detected, and all residents had at least one PIM. We also present the feasibility and the usefulness of this novel TMR for NH, illustrating these preliminary results with two concrete TMR experiences. Among the 39 TMR performed, the average acceptance rate of expert recommendations made to general practitioners (GP) working in NH was ∼33%. Discussion and Conclusions: The success of this novel TMR depends on how the proposed prescription adjustments made by the hospital expert team are subsequently integrated into health care practices. The low acceptance rate by GP highlights the need to actively involve these professionals in the process of developing TMR, with a view to encouraging them to act on proposed adjustments.

Respiratory antibacterial prescribing in primary care and the COVID-19 pandemic in England, winter season 2020-21.

BACKGROUND: Antibacterial prescribing for respiratory tract infections (RTIs) accounts for almost half of all prescribing in primary care. Nearly a quarter of antibacterial prescribing in primary care is estimated to be inappropriate, the greatest being for RTIs. The COVID-19 pandemic has changed the provision of healthcare services and impacted the levels of antibacterials prescribed. OBJECTIVES: To describe the changes in community antibacterial prescribing for RTIs in winter 2020-21 in England. METHODS: RTI antibacterial prescribing was measured in prescription items/1000 population for primary care from January 2014 and in DDDs/1000 population/day for the totality of RTI prescribing [combined with Accident & Emergency (A&E) in secondary care], from January 2016 to February 2021. Trends were assessed using negative binomial regression and seasonally adjusted interrupted time-series analysis. RESULTS: Antibacterials prescribed for RTIs reduced by a further 12.4% per season compared with pre-COVID (P < 0.001). In winter 2020-21, RTI prescriptions almost halved compared with the previous winter in 2019-20 (P < 0.001). The trend observed for total RTI prescribing (primary care with A&E) was similar to that observed in the community alone. CONCLUSIONS: During COVID-19, RTI prescribing reduced in the community and the expected rise in winter was not seen in 2020-21. We found no evidence that RTI prescribing shifted from primary care to A&E in secondary care. The most likely explanation is a decrease in RTIs and presentations to primary care associated with national prevention measures for COVID-19.

Behavioral Economics and Ambulatory Antibiotic Stewardship: A Narrative Review.

PURPOSE: Behavioral economics recognizes that contextual, psychological, social, and emotional factors powerfully influence decision-making. Behavioral economics has the potential to provide a better understanding of, and, through subtle environmental changes, or "nudges," improve persistent quality-of-care challenges, like ambulatory antibiotic overprescribing. Despite decades of admonitions and educational initiatives, in the United States, up to 50% of ambulatory antibiotic prescriptions remain inappropriate or not associated with a diagnosis. METHODS: We conducted a Medline search and performed a narrative review that examined the use of behavioral economics to understand the rationale for, and improvement of, ambulatory antibiotic prescribing. FINDINGS: Clinicians prescribe antibiotics inappropriately because of perceived patient demand, to maintain patient satisfaction, diagnostic uncertainty, or time pressure, among other reasons. Behavioral economics-informed approaches offer additional improvements in antibiotic prescribing beyond clinician education and communication training. Precommitment, in which clinicians publicize their intent to prescribe antibiotics "only when they are absolutely necessary," leverages clinicians' self-conception and a desire to act in a manner consistent with public statements. Precommitment was associated with a 20% absolute reduction in the inappropriate antibiotic prescribing for acute respiratory infections. Justification alerts, in which clinicians must provide a brief written rationale for prescribing antibiotics, leverages social accountability, redefines the status quo as an active choice, and helps clinicians to shift from fast to slow, careful thinking. With justification alerts, the absolute rate of inappropriate antibiotic prescribing decreased from 23% to 5%. Peer comparison, in which clinicians receive feedback comparing their performance to their top-performing peers, provides evidence of improved performance and leverages peoples' desire to conform to social norms. Peer comparison decreased absolute inappropriate antibiotic prescribing rates from 20% to 4%, a decrease that persisted for 12 months after the end of the intervention. Also, a one-time peer-comparison letter from a high-profile messenger to primary care practices with high rates of prescribing antibiotics, there was a 6-month, 3% decrease inantibiotic prescribing. Future directions in applying behavioral economics to the inappropriate antibiotic prescribing include paying careful attention to design details; improving intervention effectiveness and durability; making harms salient; participants' involvement in the development of interventions (the "Ikea effect"); factoring in patient satisfaction; and patient-facing nudges about antibiotic use and care-seeking. In addition, the COVID pandemic could aid in ambulatory antibiotic prescribing improvements due to changing cognitive frames around respiratory symptom evaluation and antibiotic prescribing. IMPLICATIONS: To improve ambulatory antibiotic prescribing, several behavioral economics-informed approaches-especially precommitment, justification alerts, and peer comparison-have reduced the rates of inappropriate prescribing of antibiotics to low levels.

Multifaceted antibiotic stewardship intervention using a participatory-action-research approach to improve antibiotic prescribing for urinary tract infections in frail elderly (ImpresU): study protocol for a European qualitative study followed by a pragmatic cluster randomised controlled trial.

INTRODUCTION: Almost 60% of antibiotics in frail elderly are prescribed for alleged urinary tract infections (UTIs). A substantial part of this comprises prescriptions in case of non-specific symptoms or asymptomatic bacteriuria, for which the latest guidelines promote restrictiveness with antibiotics. We aim to reduce inappropriate antibiotic use for UTIs through an antibiotic stewardship intervention (ASI) that encourages to prescribe according to these guidelines. To develop an effective ASI, we first need a better understanding of the complex decision-making process concerning suspected UTIs in frail elderly. Moreover, the implementation approach requires tailoring to the heterogeneous elderly care setting. METHODS AND ANALYSIS: First, we conduct a qualitative study to explore factors contributing to antibiotic prescribing for UTIs in frail elderly, using semi-structured interviews with general practitioners, nursing staff, patients and informal caregivers. Next, we perform a pragmatic cluster randomised controlled trial in elderly care organisations. A multifaceted ASI is implemented in the intervention group; the control group receives care as usual. The ASI is centred around a decision tool that promotes restrictive antibiotic use, supported by a toolbox with educational materials. For the implementation, we use a modified participatory-action-research approach, guided by the results of the qualitative study. The primary outcome is the number of antibiotic prescriptions for suspected UTIs. We aim to recruit 34 clusters with in total 680 frail elderly residents ≥70 years. Data collection takes place during a 5-month baseline period and a 7-month follow-up period. Finally, we perform a process evaluation. The study has been delayed for 6 months due to COVID-19 and is expected to end in July 2021. ETHICS AND DISSEMINATION: Ethical approvals and/or waivers were obtained from the ethical committees in Poland, the Netherlands, Norway and Sweden. The results will be disseminated through publication in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT03970356.

Changes in antibiotic prescribing following COVID-19 restrictions: Lessons for post-pandemic antibiotic stewardship.

AIMS: Public health responses to reduce SARS-CoV-2 transmission have profoundly affected the epidemiology and management of other infections. We examined the impact of COVID-19 restrictions on antibiotic dispensing in Australia. METHODS: We used national claims data to investigate antibiotic dispensing trends from November 2015 to October 2020 and whether changes reflected reductions in primary care consultations. We used interrupted time series analysis to quantify changes in monthly antibiotic dispensing and face-to-face and telehealth GP consultations and examined changes by recipient age, pharmacy State and prescriber specialty. RESULTS: Over the study period, an estimated 19 921 370 people had 125 495 137 antibiotic dispensings, 71% prescribed by GPs. Following COVID-19 restrictions, we observed a sustained 36% (95% CI: 33-40%) reduction in antibiotic dispensings from April 2020. Antibiotics recommended for managing respiratory tract infections showed large reductions (range 51-69%), whereas those recommended for non-respiratory infections were unchanged. Dispensings prescribed by GPs decreased from 63.5 per 1000 population for April-October 2019 to 37.0 per 1000 for April-October 2020. Total GP consultation rates remained stable, but from April 2020, 31% of consultations were telehealth. CONCLUSION: In a setting with a low COVID-19 incidence, restrictions were associated with a substantial reduction in community dispensings of antibiotics primarily used to treat respiratory infections, coincident with reported reductions in respiratory viral infections. Our findings are informative for post-pandemic antimicrobial stewardship and highlight the potential to reduce inappropriate prescribing by GPs and specialists for respiratory viral infections.

COVID-19: An Emerging Threat to Antibiotic Stewardship in the Emergency Department.

While current research efforts focus primarily on identifying patient level interventions that mitigate the direct impact of COVID-19, it is important to consider the collateral effects of COVID-19 on antimicrobial resistance. Early reports suggest high rates of antibiotic utilization in COVID-19 patients despite their lack of direct activity against viral pathogens. The ongoing pandemic is exacerbating known barriers to optimal antibiotic stewardship in the ED, representing an additional direct threat to patient safety and public health. There is an urgent need for research analyzing overall and COVID-19 specific antibiotic prescribing trends in the ED. Optimizing ED stewardship during COVID-19 will likely require a combination of traditional stewardship approaches (e.g. academic detailing, provider education, care pathways) and effective implementation of host response biomarkers and rapid COVID-19 diagnostics. Antibiotic stewardship interventions with demonstrated efficacy in mitigating the impact of COVID-19 on ED prescribing should be widely disseminated and inform the ongoing pandemic response.

Hydroxychloroquine for prophylaxis of COVID-19 physicians survey: Despite lack of evidence, many would take or give to dear ones, and despite the perceived necessity of an RCT, few would participate.

INTRODUCTION: There was no evidence concerning the prophylaxis with hydroxychloroquine, and only low-grade evidence regarding the use of hydroxychloroquine as a treatment for COVID-19 patients. We performed a survey among Romanian physicians in order to see how many of them would administer prophylactically hydroxychloroquine to themselves or to people close to them, and if they would participate to a randomized controlled trial. METHODS: Between March 30 and April 02, 2020, a 16-item questionnaire was shared in a Romanian Facebook group of 2645 physicians dedicated to COVID-19 information, asking to be completed by physicians who could be directly involved in the care of these patients. RESULTS: A total of 785 answers were collected. Nine physicians (1.1%) thought that there was clear evidence on prescribing hydroxychloroquine prophylaxis, 375 (48%) considered the evidence acceptable, 348 (44.3%) considered it weak, whereas 53 (6.8%) answered there was no evidence. 59 (7.5%) respondents were determined to take it (of which 31 = 4% already took), 192 (24.5%) were inclined to take, 271 (34.5%) were not decided yet. 175 (22.3%) of respondents declared they (would) give the treatment to their close ones, and this decision was associated with a higher age (P = 0.003), and the opinion that there was evidence (P < 0.001). When asked about the source of the treatment regimen, 286 (36.4%) indicated a scientific paper, while no scientific paper about the prophylaxis with hydroxychloroquine existed at that time. 718 (91.5%) considered a randomized clinical trial necessary (RCT), but only 333 (42.4%) answered they would enrol in such a trial. There was only a very weak correlation (Kendall's tau _b = 0.255, P < 0.001) between the belief that an RCT is necessary and the willingness to enrol in such an RCT. CONCLUSIONS: Despite the lack of evidence, many physicians considered the evidence as existing, and were ready to take or to give hydroxychloroquine prophylactically to family. They considered an RCT necessary, but they were not willing to participate.

Compassionate drug (mis)use during pandemics: lessons for COVID-19 from 2009.

BACKGROUND: New emerging infections have no known treatment. Assessing potential drugs for safety and efficacy enables clinicians to make evidence-based treatment decisions and contributes to overall outbreak control. However, it is difficult to launch clinical trials in the unpredictable environment of an outbreak. We conducted a bibliometric systematic review for the 2009 influenza pandemic to determine the speed and quality of evidence generation for treatments. This informs approaches to high-quality evidence generation in this and future pandemics. METHODS: We searched PubMed for all clinical data (including clinical trial, observational and case series) describing treatment for patients with influenza A(H1N1)pdm09 and ClinicalTrials.gov for research that aimed to enrol patients with the disease. RESULTS: Thirty-three thousand eight hundred sixty-nine treatment courses for patients hospitalised with A(H1N1)pdm09 were detailed in 160 publications. Most were retrospective observational studies or case series. Five hundred ninety-two patients received treatment (or placebo) as participants in a registered interventional clinical trial with results publicly available. None of these registered trial results was available during the timeframe of the pandemic, and the median date of publication was 213 days after the Public Health Emergency of International Concern ended. CONCLUSION: Patients were frequently treated for pandemic influenza with drugs not registered for this indication, but rarely under circumstances of high-quality data capture. The result was a reliance on use under compassionate circumstances, resulting in continued uncertainty regarding the potential benefits and harms of anti-viral treatment. Rapid scaling of clinical trials is critical for generating a quality evidence base during pandemics.

An antibiotic stewardship programme to reduce inappropriate antibiotic prescribing for acute respiratory infections in rural Chinese primary care facilities: study protocol for a clustered randomised controlled trial.

BACKGROUND: Inappropriate prescribing of antibiotics for acute respiratory infections at the primary care level represents the major source of antibiotic misuse in healthcare, and is a major driver for antimicrobial resistance worldwide. In this study we will develop, pilot and evaluate the effectiveness of a comprehensive antibiotic stewardship programme in China's primary care hospitals to reduce inappropriate prescribing of antibiotics for acute respiratory infections among all ages. METHODS: We will use a parallel-group, cluster-randomised, controlled, superiority trial with blinded outcome evaluation but unblinded treatment (providers and patients). We will randomise 34 primary care hospitals from two counties within Guangdong province into the intervention and control arm (1:1 overall ratio) stratified by county (8:9 within-county ratio). In the control arm, antibiotic prescribing and management will continue through usual care. In the intervention arm, we will implement an antibiotic stewardship programme targeting family physicians and patients/caregivers. The family physician components include: (1) training using new operational guidelines, (2) improved management and peer-review of antibiotic prescribing, (3) improved electronic medical records and smart phone app facilitation. The patient/caregiver component involves patient education via family physicians, leaflets and videos. The primary outcome is the proportion of prescriptions for acute respiratory infections (excluding pneumonia) that contain any antibiotic(s). Secondary outcomes will address how frequently specific classes of antibiotics are prescribed, how frequently key non-antibiotic alternatives are prescribed and the costs of consultations. We will conduct a qualitative process evaluation to explore operational questions regarding acceptability, cultural appropriateness and burden of technology use, as well as a cost-effectiveness analysis and a long-term benefit evaluation. The duration of the intervention will be 12 months, with another 24 months' post-trial long-term follow-up. DISCUSSION: Our study is one of the first trials to evaluate the effect of an antibiotic stewardship programme in primary care settings in a low- or middle-income country (LMIC). All interventional activities will be designed to be embedded into routine primary care with strong local ownership. Through the trial we intend to impact on clinical practice and national policy in antibiotic prescription for primary care facilities in rural China and other LMICs. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN96892547. Registered on 18 August 2019.

Safe and informed prescribing of psychotropic medication during the COVID-19 pandemic.

Treatment with psychotropic medication may sometimes be jeopardised because of the COVID-19 pandemic. One underlying reason is the lack of COVID-19-specific psychopharmacology guidelines. Here, we discuss five considerations arising from our clinical experience and pharmacological background knowledge to enable safe and well-informed psychopharmacotherapy during the COVID-19 pandemic.