ImportanceVarenicline 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.ObjectiveTo 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 ParticipantsA 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.InterventionsA 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 MeasuresThe 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.ResultsA 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 RelevanceIn 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 Registrationanzctr.org.au Identifier: ACTRN12618001792213
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.
Varenicline is an effective monotherapy for smoking cessation, but adherence is often suboptimal. This qualitative study explored the experiences of varenicline treatment among participants enrolled in a randomized controlled trial, who self-reported being adherent or nonadherent to varenicline treatment (n = 15). Individual interviews were conducted using a semi-structured interview guide. Data were analyzed using thematic framework approach. An environment of forced abstinence played a key role in motivating quit attempts. The main barriers to varenicline adherence were medicine-related side effects, relapse to smoking, and a belief that the medication was not working if abstinence was not achieved by the target quit date. Participants adherent to treatment adopted a reduce-to-quit approach and noticed a gradual reduction in cigarette cravings. When asked about their preferences for support while on varenicline treatment, participants expressed the need for proactive follow-up by health professionals and more active behavioral support to assist them in adhering to treatment. Prescribers should encourage varenicline users to persist with treatment, even if abstinence is not achieved by the target quit date. Further research is needed to explore the awareness and acceptability of the reduce-to-quit method among prescribers and patients and its impact on varenicline adherence and in term long-term abstinence.
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).
INTRODUCTION AND AIMS:Nicotine replacement therapy (NRT) is recommended as a smoking cessation aid for hospitalised smokers. We examined factors associated with NRT use during hospitalisation and after discharge, and NRT uptake when systematically offered free of cost.DESIGN AND METHODS:A nested analysis was conducted using data from a clinical trial that evaluated the effectiveness of a pharmacist-led smoking cessation intervention in 600 hospitalised smokers.RESULTS:NRT was used at least once by 285 (48%) participants during hospitalisation and by 287 (48%) participants during the 12 months post-discharge. Heavy smokers and those who expressed interest in using NRT for their next quit attempt at baseline interview were more likely to use NRT during hospitalisation [odds ratio (OR) 1.94, 95% confidence interval (CI) 1.38, 2.74; OR 2.09, 95% CI 1.48, 2.95] and after discharge (OR 1.70, 95% CI 1.20, 2.41; OR 1.97, 95% CI 1.39, 2.79). Those using six or more medications were more likely to use NRT during hospitalisation (OR 1.65, 95% CI 1.05, 2.61). Post-discharge NRT users were more likely to have been initially admitted for a respiratory or cardiac problem (OR 1.51, 95% CI 1.05, 2.18). When NRT was offered free of cost to a subset of patients (n = 300), 157 (52%) used NRT during hospitalisation. Nicotine dependence and interest in using NRT predicted its use (OR 2.26, 95% CI 1.38, 3.70; OR 2.58, 95% CI 1.58, 4.20).DISCUSSION AND CONCLUSIONS:Targeting heavy smokers, those with cardio-respiratory conditions and those interested in using NRT regardless of regimen complexity could improve NRT uptake.
AIMS To evaluate the effectiveness of a pharmacist-led multi-component smoking cessation programme (GIVE UP FOR GOOD) compared with usual care in hospitalized smokers. DESIGN Randomized, assessor-blinded, parallel-group trial. SETTING Three tertiary public hospitals in Australia. PARTICIPANTS A total of 600 adult in-patient smokers [mean ± standard deviation (SD), age 51 ± 14 years; 64% male] available for 12 months follow-up. INTERVENTIONS Multi-component hospital pharmacist-led behavioural counselling and/or pharmacotherapy provided during hospital stay, on discharge and 1 month post-discharge, with further support involving community health professionals (n = 300). Usual care comprised routine care provided by hospitals (n = 300). MEASUREMENTS Two primary end-points were tested using intention-to-treat analysis: carbon monoxide (CO)-validated 1-month sustained abstinence at 6-month follow-up and verified 6-month sustained abstinence at 12-month follow-up. Smoking status and pharmacotherapy usage were assessed at baseline, discharge, 1, 6 and 12 months. FINDINGS Sustained abstinence rates for intervention and control groups were not significantly different at both 6 months [11.6% (34 of 294) versus 12.6% (37 of 294); odds ratio (OR) = 0.91, 95% confidence interval (CI) = 0.55-1.50] and 12 months [11.6% (34 of 292) versus 11.2% (33 of 294); OR = 1.04, 95% CI = 0.63-1.73]. Secondary end-points, self-reported continuous abstinence at 6 and 12 months, also agreed with the primary end-points. Use of pharmacotherapy was higher in the intervention group, both during hospital stay [52.3% (157 of 300) versus 42.7% (128 of 300); P = 0.016] and after discharge [59.6% (174 of 292) versus 43.5% (128 of 294); P < 0.001]. CONCLUSIONS A pharmacist-led multi-component smoking cessation intervention provided during hospital stay did not improve sustained abstinence rates at either 6 or 12 months compared with routine hospital care.
OBJECTIVE:Identification of challenges associated with quitting and overcoming them may improve cessation outcomes. This study describes the development and initial validation of a scale for measuring challenges to stopping smoking.METHODS:The item pool was generated from empirical and theoretical literature and existing scales, expert opinion and interviews with smokers and ex-smokers. The questionnaire was administered to smokers and recent quitters who participated in a hospital-based smoking cessation trial. Exploratory factor analysis was performed to identify subscales in the questionnaire. Internal consistency, validity and robustness of the subscales were evaluated.RESULTS:Of a total of 182 participants with a mean age of 55 years (SD 12.8), 128 (70.3%) were current smokers and 54 (29.7%) ex-smokers. Factor analysis of the 21-item questionnaire resulted in a 2-factor solution representing items measuring intrinsic (9 items) and extrinsic (12 items) challenges. This structure was stable in various analyses and the 2 factors accounted for 50.7% of the total variance of the polychoric correlations between the items. Internal consistency (Cronbach's α) coefficients for the intrinsic and extrinsic subscales were 0.86 and 0.82, respectively. Compared with ex-smokers, current smokers had a higher mean score (± SD) for intrinsic (24.0 ± 6.4 vs 20.5 ± 7.4, p=0.002) and extrinsic subscales (22.3 ± 7.5 vs 18.6 ± 6.0, p=0.001).CONCLUSIONS:Initial evaluation suggests that the 21-item challenges to stopping smoking scale is a valid and reliable instrument that can be used in research and clinical settings to assess challenges to stopping smoking.
ObjectiveUnderstanding smokers’ quit experiences and their preferences for a future quit attempt may aid in the development of effective cessation treatments. The aims of this study were to measure tobacco use behaviour; previous quit attempts and outcomes; methods used to assist quitting; difficulties experienced during previous attempts; the motives and preferred methods to assist quitting in a future attempt; identify the factors associated with preferences for smoking cessation.DesignFace-to-face interview using a structured questionnaire.SettingInpatient wards of three Australian public hospitals.ParticipantsHospitalised smokers enrolled in a smoking cessation trial.ResultsOf 600 enrolled patients (42.8% participation rate), 64.3% (n=386) had attempted quitting in the previous 12 months. On a scale of 1 (low) to 10 (high), current motivation to quit smoking was high (median 9; IQR 6.5–10), but confidence was modest (median 5; IQR 3–8). Among 386 participants who reported past quit attempts, 69.9% (n=270) had used at least one cessation aid to assist quitting. Nicotine replacement therapy (NRT) was most commonly stated (222, 57.5%), although the majority had used NRT for <4 weeks. Hypnotherapy was the most common (68, 17.6%) non-pharmacological treatment. Over 80% (n=311) experienced withdrawal symptoms; craving and irritability were commonly reported. Most participants (351, 58.5%) believed medications, especially NRT (322, 53.7%), would assist them to quit in the future. History of previous smoking cessation medication use was the only independent predictor of interest in using medications for a future quit attempt.ConclusionsThe majority of smokers had attempted quitting in the previous 12 months; NRT was a popular cessation treatment, although it was not used as recommended by most. This suggests a need for assistance in the selection and optimal use of cessation aids for hospitalised smokers.Trial registration numberAustralian and New Zealand Clinical Trials Registry: ACTRN12612000368831.
Background: Emergency departments (EDs) face increasing service demands and the imposition of treatment targets which has led to continual process redesign and changes in staff skill mix and functions.Objective: To identify extended ED pharmacist roles that could improve medication management and to implement and evaluate one such role change.Methods: A focus group of clinicians sought to redesign processes around ED medication management. Preparation of medication charts for patients admitted from ED was selected. Baseline data were obtained to define elements of existing medication charting processes. Suitably trained ED pharmacists' trialled the effectiveness of making therapeutic suggestions on a medication chart 'sticker' or by direct 'consultation' with medical staff. At the conclusion of the study focus groups at each site evaluated clinical staff perceptions of the change.Results: Focus group participants thought that ED pharmacists could undertake extended roles in analgesia, nausea control, antibiotic cover, addiction management and preparation of medication charts for admitted patients. In the pre-intervention audit (n = 140), 74% required at least one intervention by the ward pharmacists to address medication discrepancies. Ward pharmacists detected 292 medication discrepancies (median 1, IQR 0-3). In the 'sticker' intervention the ED pharmacist made 84 therapeutic suggestions of which 66 (78.6%) were accepted by medical staff. In the 'consultation' intervention 230 therapeutic suggestions were made of which 219 (95.2%) were accepted. The qualitative evaluation found that pharmacist-prepared medication charts within the processes established were deemed safe, timely, accurate, complete and legible.Conclusion: Support exists for ED pharmacists to expand their medication-related roles. ED pharmacists can safely prepare medication charts in a timely fashion and their therapeutic suggestions within a 'consultative' framework are more beneficial than written advice. However, issues relating to resourcing, hours of service, service focus, statutory restrictions and training support for extended roles require resolution. (C) 2014 Elsevier Inc. All rights reserved.
Intensive smoking cessation interventions initiated during hospitalisation are effective, but currently not widely available. Strategies are needed to integrate smoking cessation treatment into routine inpatient care. Pharmacist-led interventions for smoking cessation are feasible and efficacious in both ambulatory and community pharmacy settings. However, there is a lack of evidence from large scale studies of the effectiveness of pharmacist guided programs initiated during patient hospitalisation in achieving long-term abstinence. This study aims to evaluate the effectiveness of a pharmacist-led system change intervention initiated during hospitalisation in Australian public hospitals.
ABSTRACTAimTo report patient and pharmacist experiences with a pharmacist‐led lipid clinic for surgical patients with PVD.MethodA pharmacist completed a non‐medical prescribing course and tutelage under a cardiologist to enhance consultation and lipid management skills. Eligible patients were randomised into control or intervention groups. The intervention group was reviewed by the pharmacist during four 6‐weekly visits, and given lifestyle advice, lipid levels measured, and (if required) statins were initiated or adjusted. The control group was given dietary advice, a booklet on cholesterol management and lipid levels measured at baseline and 6 months. The intervention group completed a questionnaire on their experiences. The pharmacist's reflections on their role were also recorded.ResultsOf the 8 intervention group patients who completed the study, 5 reduced their low‐density lipoprotein (LDL) levels below 2 mmol/L, 2 reduced their LDL to 2 and 2.1 mmol/L, and 1 maintained their LDL at 2 mmol/L (mean 1.8, range 1.3–2.1). The entire control group (n = 6) had elevated LDL levels (mean 2.9 mmol/L, range 2.3–3.9). Statins were initiated or adjusted in 4 intervention group patients. Participants were highly satisfied with their pharmacist consultations. The pharmacist was positive about the training, self confidence and ability to answer questions, and less positive about the clinic setting, usefulness of the algorithm and point‐of‐care cholesterol testing.ConclusionA suitably trained hospital pharmacist can undertake extended roles with a prescribing element. However, the patient group and setting require careful consideration.
ABSTRACTBackgroundLegislative change and a university course to credential pharmacist prescribers are needed to move the pharmacist prescribing agenda forward in Australia. Non‐medical prescribing courses in the UK aim to produce safe and competent prescribers who understand the prescribing process, know their limitations and practice within their area of competence. As no equivalent course exists in Australia there was interest in exploring whether a UK non‐medical prescribing course could be adopted for the Australian environment.AimTo pilot a UK non‐medical prescribing course for Australian hospital pharmacists and to elicit participants' views on non‐medical prescribing and experiences of the training.MethodThe Department of Pharmacy Practice, Monash University hosted a non‐medical prescribing course accredited by the Royal Pharmaceutical Society of Great Britain to credential pharmacists as supplementary and independent prescribers. 15 hospital pharmacists undertook the course over 9 months from September 2008. Participating pharmacists were either undertaking or planning to undertake advanced practitioner roles. Pharmacists' views on prescribing and credentialling were explored in 3 focus groups. Focus group discussions were audio‐recorded and transcribed verbatim and thematically analysed using NVivo 8.ResultsParticipants identified positive themes of their understanding of non‐medical prescribing and where it could lead, i.e. growth in self‐confidence to undertake a new role and improved competency in communication and consultation skills. Negative themes related to legislative constraints, acceptance by other health professionals, assessment requirements for the Period of Learning in Practice and university documentation. Participants also stressed the need for the course to be customised to the Australian setting.ConclusionThis first experience of a course to develop pharmacist prescribing was positive but challenging and can assist the future development of an accredited Australian course for pharmacist prescribers.
ABSTRACTAimTo explore the views of SHPA pharmacist members on collaborative prescribing and the extent of de facto prescribing at their institutions.Method1367 SHPA pharmacist members were invited by mail to complete a 4–page questionnaire on current and future issues pertaining to collaborative prescribing.Results551 pharmacist members responded (40% response rate) to the survey. 509 (95%) respondents observed that a collaborative prescribing role could circumvent hospital delays with timely service delivery during the admission, inpatient, discharge and outpatient process. De facto prescribing was undertaken by 141 (37%) pharmacists across the range of drug schedules and practice settings. If a legal and credentialling framework existed, 406 (75%) pharmacists would consider becoming a ‘prescribing pharmacist’ in a specialised clinical area, while 81 (15%) were undecided and 57 (11%) would not consider the option.ConclusionSHPA pharmacist members strongly supported the development of collaborative prescribing as a means to improve patient outcomes, professional activities and standing, and hospital systems. Hospital pharmacists are undertaking a range of de facto prescribing activities.
ABSTRACTAimTo determine whether pharmacist‐initiated electronic discharge prescribing would decrease discharge times for selected cardiology patients and improve the accuracy of prescribing by limiting deviations from the intended therapeutic plan.MethodA cardiology project team identified system issues impeding patient flow through the ward, including the discharge medication pathway. The stages of the medication pathway were mapped before and after the intervention of pharmacist‐initiated electronic discharge prescribing. The accuracy of prescribing in both phases of the study was measured against evidence‐based standards agreed by the cardiology unit.Results39 patients were recruited in phase 1 (usual practice) and 35 patients in phase 2 (pharmacist‐initiated discharge prescriptions). The time from a decision to discharge a patient to the completed prescription reaching the patient was significantly reduced from a median of 190 minutes to 50 minutes in the intervention arm (p < 0.0001). However, this result did not translate into patients leaving the hospital earlier. In phase 1, 26% of prescriptions (n = 39) contained at least one error, including 19 clinically significant omissions. In phase 2, no omissions were made but the signing doctor made two changes to the pharmacist‐initiated prescriptions that were unrelated to the evidence‐based standards.ConclusionThis pilot study has shown that an experienced pharmacy specialist using an electronic discharge prescribing system can significantly reduce the time elements of the discharge medication pathway. In addition, errors of omission that deviate from evidence‐based practice are reduced. This practice model can be extended to other specialist areas.
Upon admission, medication history is an integral part of the medication reconciliation process; however, it is difficult to obtain one that is accurate and complete. A patient's reliability as historian, in addition to time constraints often placed upon the health care provider are factors that can reduce the accuracy and completeness of a medication history. A system is described that provides medication reconciliation including medication fill and refill information from third-party payers and pharmacy-benefit managers (PBM). Thomas Hospital in Fairhope, Alabama is the initial site deploying the system. Information about the patient's prescription medications is retrieved upon admission and presented to history takers and prescribers, in electronic and/or paper format, as admission orders are being written. Data retrieval and presentation are automatic, and the information is seamlessly integrated into the entire medication reconciliation progression, from admission, through patient transfers, and the discharge process. Analyzing and amending hospital systems and procedures is a complex and time consuming process. However, when patient care and safety can be significantly and directly impacted, it becomes apparent that the institution must allocate personnel and resources to foster the initiative. Thomas Hospital, a 150 bed acute care facility, in Fairhope, Alabama reviewed its admission, transfer, and discharge procedures with a focus on improving the medication reconciliation process. This commitment resulted in a redesign of the system that included automated retrieval of the patient's medication history.
Journal of Pharmacy Practice and ResearchVolume 34, Issue 1 p. 4-5 EditorialFree Access Pharmacist Prescribing: Let's Have the Debate Greg R Weeks MPharm, MHA, FSHP, Greg R Weeks MPharm, MHA, FSHP Director of Pharmacy greg@barwonhealth.org.au Barwon Health Geelong Vic. 3220 AustraliaSearch for more papers by this author Greg R Weeks MPharm, MHA, FSHP, Greg R Weeks MPharm, MHA, FSHP Director of Pharmacy greg@barwonhealth.org.au Barwon Health Geelong Vic. 3220 AustraliaSearch for more papers by this author First published: 01 March 2004 https://doi.org/10.1002/jppr20043414Citations: 4AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. References 1Hughes DS, Kinnear AE, Macintyre JL, Pacittii L. Collaborative medicines management: pharmacist prescribing. Pharm J 1999; 263: 170– 2 2 Task Force on Pharmacist Prescribing. Information paper on pharmacist prescribing within a health care facility. Canadian Society of Hospital Pharmacists, August 2001. Available from . Accessed 21 February 2004 3 Department of Health. Supplementary prescribing by nurses and pharmacists within the NHS in England, March 2003. Available from . Accessed 21 February 2004 4Jones G, Graham R. Pharmacist prescribing. Hosp Pharm 2003; 10: 472– 4 5Jones G. Pharmacist prescribing-from concept to reality [editorial]. Hosp Pharm 2003; 10: 466 6McFadzean E, Isles C, Moffat J, Norrie J, Stewart D. Is there a role for a prescribing pharmacist in preventing prescribing errors in a medical adntission unit? Pharm J 2003; 270: 896– 9 Citing Literature Volume34, Issue1March 2004Pages 4-5 ReferencesRelatedInformation