Varenicline and Nicotine Replacement Therapy for Smokers Admitted to Hospitals: A Randomized Clinical Trial.

Importance: Varenicline is the most effective sole pharmacotherapy for smoking cessation. If used in combination with nicotine replacement therapy (NRT), cessation rates may be further improved, but the efficacy and safety of the combination need to be evaluated. Objective: To examine whether hospitalized smokers treated with varenicline and NRT lozenges achieve higher prolonged smoking abstinence rates compared with those treated with varenicline alone. Design, Setting, and Participants: A double-blind, placebo-controlled randomized clinical trial was conducted in adult medical or surgical inpatients of 5 Australian public hospitals with a history of smoking 10 cigarettes or more per day, interested in quitting, and available for 12-month follow-up between May 1, 2019, and May 1, 2021 (final 12-month data collection in May 2022). Data analysis was performed from June 1 to August 30, 2023. Interventions: A 12-week varenicline regimen was initiated during hospitalization at standard doses in all participants. Participants were randomized to additionally use NRT (2 mg) or placebo lozenges if there was an urge to smoke. Behavioral support (Quitline) was offered to all participants. Main Outcomes and Measures: The primary outcome was biochemically verified sustained abstinence at 6 months. Secondary outcomes included self-reported prolonged abstinence, 7-day point prevalence abstinence (3, 6, and 12 months), and medicine-related adverse events. Results: A total of 320 participants (mean [SD] age, 52.5 [12.1] years; 183 [57.2%] male) were randomized. The conduct of biochemical verification was affected by COVID-19 restrictions; consequently, the biochemically verified abstinence in the intervention vs control arms (18 [11.4%] vs 16 [10.1%]; odds ratio [OR], 1.14; 95% CI, 0.56-2.33) did not support the combination therapy. The secondary outcomes in the intervention vs control arms of 7-day point prevalence abstinence at 6 months (54 [34.2%] vs 37 [23.4%]; OR, 1.71; 95% CI, 1.04-2.80), prolonged abstinence at 12 months (47 [29.9%] vs 30 [19.1%]; OR, 1.77; 95% CI, 1.05-3.00), and 7-day point prevalence abstinence at 12-months (48 [30.6%] vs 31 [19.7%]; OR, 1.79; 95% CI, 1.07-2.99) significantly improved with the combination therapy. The self-reported 6-month prolonged abstinence (61 [38.6%] vs 47 [29.7%]; OR, 1.49; 95% CI, 0.93-2.39) favored the combination therapy but was not statistically significant. Medicine-related adverse events were similar in the 2 groups (102 [74.5%] in the intervention group vs 86 [68.3%] in the control group). Conclusions and Relevance: In this randomized clinical trial of the combination of varenicline and NRT lozenges in hospitalized adult daily smokers, the combination treatment improved self-reported abstinence compared with varenicline alone, without compromising safety, but it did not improve biochemically validated abstinence. Trial Registration: anzctr.org.au Identifier: ACTRN12618001792213.

Which smokers enroll in a hospital based smoking cessation trial? Survey of smoking related behaviors, quit attempts, and motivation to quit.

BACKGROUND: Understanding smoking behaviors in hospital patients who smoke may improve inpatient cessation treatments. This study aimed to describe smoking-related behaviors, past-quit attempts, and self-reported difficulties experienced in quitting among those who enrolled in a smoking cessation trial of varenicline. METHODS: Baseline data were obtained from adult hospitalized smokers (average ≥ 10 cigarettes/day in 4-weeks prior to hospitalization) who enrolled in a randomized, placebo-controlled trial of varenicline ± nicotine lozenges at five Australian public hospitals. A logistic regression model tested the association between participant characteristics and quitting in the previous 12 months. RESULTS: Participants' (n = 320; 57% male, 52.5 ± 12.1 years old) motivation and confidence in quitting were high. A total of 120 participants (37.5%) had attempted quitting in the previous 12-months. Prior hospitalization (P = .008) and employment status (P = .015) were significantly associated with past quit attempts. No statistically significant differences were noted in the reason for hospitalization or the level of nicotine dependence between participants who attempted quitting in the previous 12 months and their counterparts. Smoking cessation pharmacotherapy was used by 55% of those attempting to quit; nicotine replacement therapy (65.2%) and varenicline (16.7%) most common. Stress or anxiety, urges to smoke and a lack of motivation were the difficulties experienced in past quit attempts. CONCLUSIONS: Those who had a prior hospitalization and were unemployed had significantly greater odds of reporting past quit attempts. Further research is needed to investigate the degree of adherence among inpatient smokers with the smoke-free hospital policies and the frequency of NRT provision and uptake on admission.

Medication not accounted for in hospital electronic medication administration records: a retrospective observational study.

OBJECTIVE: To determine the nature, extent, and cost of discrepancies between the quantities of medications supplied to medical departments and administered to patients in public hospitals. DESIGN: Multicentre, retrospective observational study; analysis of electronic pharmacy drug management system (medication supply) and medication administration data for twenty frequently used medications. SETTING, PARTICIPANTS: Medical, surgical, and emergency department (ED) wards in each of four public hospitals in Melbourne, Victoria, during the 2019 calendar year. MAIN OUTCOME MEASURES: Discrepancy between the quantity of medication supplied and administered to patients (as proportion of medication supplied), overall and by hospital and ward type; direct cost to the hospitals of the discrepancies. RESULTS: The overall discrepancy rate (all medications, hospitals, ward types) was 19.2% (95% CI, 19.0-19.4%); overall rates by hospital ranged from 5.8% (95% CI, 5.7-5.9%) to 26.7% (95% CI, 26.6-26.9%). The discrepancies were largest for medications useful for self-treatment: oral antibiotics (eg, phenoxymethylpenicillin 250 mg capsule, 86.8%; 95% CI, 83.1-89.9%) and gastrointestinal medications (eg, ondansetron 4 mg tablet, 53.3%; 95% CI, 52.9-53.7%). Discrepancies were larger for oral than equivalent (or similar) parenteral formulations; they were generally low for controlled medications (temazepam, diazepam, oxycodone). Overall discrepancies were larger for EDs (32.3%; 95% CI, 32.2-32.5%) than for admitted patient wards, but differed between EDs (range: 25.7%; 95% CI, 25.5-26.0% to 39.5%; 95% CI, 39.2-39.7%). The estimated direct cost to hospitals of the discrepancies for the selected medications was $27 800. CONCLUSION: Substantial quantities of medications supplied to hospital wards and EDs are not accounted for in electronic administration records.

The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial.

INTRODUCTION: Smoking is a leading cause of premature deaths globally. The health benefits of smoking cessation are many. However, majority of quit attempts are unsuccessful. One way to potentially improve success rates is to evaluate new combinations of existing smoking cessation therapies that may work synergistically to decrease the intensity of withdrawal symptoms and cravings. AIMS: To evaluate the feasibility, efficacy and safety of the combination of varenicline and nicotine replacement therapy (NRT) lozenges versus varenicline alone in assisting hospitalised smokers to quit. METHODS AND ANALYSIS: This is a multicentre, randomised, placebo-controlled trial. Adults with a history of smoking ≥10 cigarettes per day on average in the 4 weeks prior to their hospitalisation will be recruited. Participants will be randomly assigned to either the intervention group and will receive varenicline and NRT lozenges, or the control group and will receive varenicline and placebo lozenges. All participants will be actively referred to behavioural support from telephone Quitline. Participants are followed up at 1 and 3 weeks and 3, 6 and 12 months from the start of treatment. The primary outcome is carbon monoxide validated prolonged abstinence from 2 weeks to 6 months after treatment initiation. Secondary outcomes include self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others. According to the Russell Standard, all randomised participants will be accounted for in the primary intention-to-treat analysis. ETHICS AND DISSEMINATION: The trial will be conducted in compliance with the protocol, the principles of Good Clinical Practice, the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (updated 2015) and the Australian Code for the Responsible Conduct of Research (2018). Approval will be sought from the Human Ethics Committees of all the participating hospitals and the university. Written informed consent will be obtained from each participant at the time of recruitment. TRIAL REGISTRATION NUMBER: Australia New Zealand Clinical Trials Registry (ACTRN12618001792213).

Attitudes and beliefs of Australian emergency department clinicians on antimicrobial stewardship in the emergency department: A qualitative study.

OBJECTIVE: To explore the attitudes and beliefs of Australian ED clinicians towards antimicrobial stewardship in the ED. METHODS: Semi-structured one-to-one interviews were conducted with ED clinicians between March and October 2015. Participants were identified via purposive and snowball sampling. Questionnaires were developed using the literature. Interviews were audio-recorded, transcribed and analysed using thematic analysis via the framework approach. Two researchers coded independently, with one using QSR International's NVivo 10 software and the other manually. Emergent themes were identified and classified. RESULTS: Twenty-two clinicians (eight doctors, eight nurses and six pharmacists) from seven institutions participated. Participants were aware and concerned about antimicrobial resistance. Clinicians were divided based on their opinion on whether antimicrobials are prescribed appropriately and judiciously in the ED, with many perceiving prescribing to be inappropriate. Prior knowledge of the term 'Antimicrobial Stewardship' was demonstrated by doctors and pharmacists, with a relative lack of awareness by nurses. Four main themes were identified as both barriers and facilitators to antimicrobial stewardship in the ED: individual healthcare provider, resource, organisational and cultural. Uncertainty of diagnosis, time and resource pressures, reliance on previous experience and lack of access to expert opinion were perceived barriers. To facilitate appropriate prescribing, clinicians emphasised the need for routine education and feedback, adequate staffing, robust guidelines, senior medical clinician advocacy and multidisciplinary support. CONCLUSIONS: Australian ED clinicians were aware of antimicrobial resistance. Many perceive injudicious antimicrobial use as problematic. Consideration of ED clinicians' perceived barriers and facilitators might enhance implementation of antimicrobial stewardship programmes in EDs.

Improving communication of medication changes using a pharmacist-prepared discharge medication management summary.

Background Discontinuity of care between hospital and primary care is often due to poor information transfer. Medication information in medical discharge summaries (DS) is often incomplete or incorrect. The effectiveness and feasibility of hospital pharmacists communicating medication information, including changes made in the hospital, is not clearly defined. Objective To explore the impact of a pharmacist-prepared Discharge Medication Management Summary (DMMS) on the accuracy of information about medication changes provided to patients' general practitioners (GPs). Setting Two medical wards at a major metropolitan hospital in Australia. Method An intervention was developed in which ward pharmacists communicated medication change information to GPs using the DMMS. Retrospective audits were conducted at baseline and after implementation of the DMMS to compare the accuracy of information provided by doctors and pharmacists. GPs' satisfaction with the DMMS was assessed through a faxed survey. Main outcome measure Accuracy of medication change information communicated to GPs; GP satisfaction and feasibility of a pharmacist-prepared DMMS. Results At baseline, 263/573 (45.9%) medication changes were documented by doctors in the DS. In the post-intervention audit, more medication changes were documented in the pharmacist-prepared DMMS compared to the doctor-prepared DS (72.8% vs. 31.5%; p < 0.001). Most GPs (73.3%) were satisfied with the information provided and wanted to receive the DMMS in the future. Completing the DMMS took pharmacists an average of 11.7 minutes. Conclusion The accuracy of medication information transferred upon discharge can be improved by expanding the role of hospital pharmacists to include documenting medication changes.