Recommendation 10 — Varenicline should be recommended to people who smoke and who have been assessed as clinically suitable for this medication; it should be provided in combination with behavioural support. Two randomised controlled trials have examined varenicline as an aid to relapse prevention in those who smoked and had successfully quit on varenicline. The evidence review conducted by JBI on this question examined the two trials 62,63 which, combined, involved participants that met entry criteria including that smoking cessation of study participants was biochemically confirmed.
Recommendation 11 — For people who have abstained from smoking after a standard course of varenicline in combination with behavioural support, clinicians may consider a further course of varenicline to reduce relapse. Varenicline in combination with NRT patch results in significantly higher abstinence rates than varenicline alone.
Frequency of headaches was similar between groups 7. Koegelenberg and colleagues reported that skin reactions of any type were more prevalent in the combination therapy group The evidence review conducted by JBI on this question found two trials involving participants that met entry criteria including biochemically confirmed cessation.
The EAG rated the certainty of the evidence as moderate, and concluded that, on current evidence, there is a small but not trivial improvement in smoking cessation for people taking varenicline in addition to NRT, compared to NRT alone.
Recommendation 12 — For people who are attempting to quit smoking using varenicline accompanied by behavioural support, clinicians might recommend the use of varenicline in combination with nicotine replacement therapy, compared with varenicline alone.
Conditional recommendation for the intervention, moderate certainty. There is no clinical study of varenicline combined with oral NRT. However, in clinical practice, this combination is sometimes used together. Varenicline helps to relieve background cravings and reduce the stimulatory effects of smoking, and oral NRT products alleviate cue-induced triggers. There is a lack of evidence of the effectiveness of combination varenicline plus bupropion. One study found a benefit at 26 weeks, but not at 52 weeks; a more recent study found no benefit at either of these follow-up points.
There is increasing evidence of the efficacy of varenicline in sub-populations of patients who smoke. Psychiatric comorbidity is common in those who smoke, and varenicline has been found to be safe and effective in those with stable mental illness or a past history of mental illness.
Varenicline is more effective than other cessation monotherapies, but the difference is relatively greater for women. Women have lower quit rates with NRT and bupropion compared with men, but the same response to varenicline.
Varenicline reduces alcohol cravings and overall alcohol consumption in those who drink heavily, and may have a role in the concurrent treatment of alcohol and nicotine dependence, especially in men. After initial marketing of varenicline, there were concerns about an association between varenicline and mood changes, depression, behaviour disturbance and suicidal ideation. Subsequent meta-analyses of randomised controlled trials 76,77 and observational studies 72,78,79 have not supported a causal link.
As expected, those with mental illness in all treatment groups had higher rates of neuropsychiatric adverse events than those without mental illness. Patients quitting smoking with any method are at some risk of increased psychological stress, especially those with a history of mental illness. Clinicians should monitor all patients with follow-up for neuropsychiatric changes associated with withdrawals, whether taking varenicline or not, and should promptly report any adverse events.
These randomised controlled trials found that cardiovascular events are rare and not likely to be increased with the use of varenicline. It is important to note that smoking is a major risk factor for cardiovascular disease, and the health benefits of quitting smoking are immediate and substantial. Due to the limited efficacy and pregnancy safety data, varenicline is not recommended as a smoking cessation aid for pregnant or breastfeeding women.
Sleep disturbance and abnormal dreams were more common in the varenicline group Other less common side effects include drowsiness, headache, constipation, dizziness and flatulence.
Varenicline is excreted almost entirely by the kidneys. Avoid varenicline in those with end-stage renal failure in favour of other approaches to smoking cessation. Dose adjustment is not routinely required in older people or in people with hepatic impairment. Bupropion has been shown to be effective in a range of patient populations, including those with depression, cardiac disease and respiratory diseases eg chronic obstructive pulmonary disease [COPD].
Clinical trials have shown that bupropion is not as effective as varenicline for smoking cessation. The combination of NRT and sustained-release bupropion has not shown an additive benefit. Bupropion is contraindicated in patients with a history of seizures, eating disorders and those currently or recently within the last 14 days taking monoamine oxidase inhibitors.
A sudden decrease in alcohol consumption can also alter the seizure threshold, and alternative medication should be considered in these situations. Caution is needed if there is concomitant use of bupropion with certain drugs eg tricyclic antidepressants, selective serotonin reuptake inhibitors [SSRIs]. These drugs should be initiated at the lower end of the dosage range while the individual is taking bupropion.
In the more common situation where bupropion is initiated for a person already taking these drugs, these may need to be decreased. Bupropion should not be used in patients taking monoamine oxidase inhibitors, including moclobemide. A day washout is recommended between completing monoamine oxidase inhibitors and starting bupropion. Consultation with a psychiatrist may be considered for advice on co-prescribing bupropion with other antidepressants.
There is no evidence that the use of bupropion for smoking cessation increases the risk of serious cardiovascular adverse events during or after treatment.
Seizures are the most clinically important adverse effect 0. Common adverse effects are insomnia, headache, dry mouth, nausea, dizziness and anxiety. If bupropion is used in combination with NRT, blood pressure should be monitored. Recommendation 13 — Bupropion sustained release should be recommended to people who have been assessed as clinically suitable for this medication; it should be provided in combination with behavioural support. Bupropion is less effective than either varenicline or combination nicotine replacement therapy.
The subsidised patches are not available at the same time as other PBS-subsidised smoking cessation therapies ie varenicline, bupropion , but those who are unsuccessful at quitting using the nicotine patches are able to access PBS-subsidised medicines during that same month period. Aboriginal and Torres Strait Islander peoples qualify for a PBS-restricted benefit listing, which provides up to two courses of nicotine patches per year, each a maximum of 12 weeks.
Under this listing, participation in a support and counselling program is recommended but not mandatory. Nicotine gum 2 mg and 4 mg doses and lozenge 2 mg and 4 mg doses are also available on the PBS for Aboriginal and Torres Strait Islander peoples.
Varenicline is available on the PBS as a short-term adjunctive therapy for nicotine dependence. It can be prescribed as a streamlined authority prescription for up to 24 weeks of continuous therapy for smoking cessation. Eligibility requirements include enrolling in a support and counselling program, and abstinence at 12 weeks.
The first script is a starter pack that lasts for four weeks including dose titration , followed by a continuation batch for eight weeks of treatment. A third prescription is required for the final 12 weeks of treatment, but only for those who respond to the first 12 weeks. Sustained-release bupropion is available on the PBS as a streamlined authority prescription for a short-term course of treatment nine weeks for nicotine dependence, with a comprehensive support and counselling program.
Bupropion is available as a starter pack of 30 tablets and a continuation pack of 90 tablets. The patient should stop smoking in the second week of treatment. Nortriptyline is a tricyclic antidepressant that has been shown in a relatively small number of trials to significantly increase long-term cessation when used as the sole pharmacotherapy. Nortriptyline can be dangerous in overdose. Further information about nortriptyline for smoking cessation can be obtained from the New Zealand smoking cessation guidelines.
Recommendation 14 — Nortriptyline should be considered as a second-line pharmacotherapy agent because of its adverse effects profile. Products that contain nicotine in salt or base form in a solution designed to be inhaled using a vaping device. Includes vape liquids, e-liquids and e-juices that contain nicotine, and the nicotine solution in nicotine e-cigarettes and pods. Electronic devices used to heat vaping products to release an aerosol that is inhaled. Includes e-cigarettes, e-cigars, e-hookah pens, e-pens, e-pipes and vape pens.
Electronic cigarettes, often referred to as e-cigarettes, are a diverse range of battery-powered devices that deliver nicotine aerosol without tobacco or smoke. The vaping device heats an e-liquid — also known as the nicotine vaping product NVP — into an aerosol for inhalation. Beside nicotine, the e-liquid usually contains propylene glycol and glycerol, with or without flavours.
Nicotine in e-liquid can be in free-base original or salt form. In both cases the active ingredient is nicotine. The nicotine salt is associated with less throat irritation allowing for higher concentrations of nicotine to be used. The pharmacokinetics of nicotine delivery, which includes rapidity of onset and peak nicotine levels, is variable and is a function of the form of the nicotine, NVP concentration, the vaping device, and inhalation technique.
There is a broad range of vaping devices, which can be open or closed systems, and refillable or non-refillable. Closed system devices include prefilled cartridges, pods or other disposables where the e-liquid is enclosed in a sealed container. Under existing state and territory laws, the domestic sale of NVPs to consumers without a prescription is illegal throughout Australia. Additionally, the possession or use of these products without a prescription is illegal in all states and territories.
This means that from 1 October , consumers will require a prescription for all purchases of all NVPs, regardless of where they are sourced from. The regulatory arrangements for NVPs vary considerably within and across countries, ranging from prohibition to minimal or no regulation.
In Australia, NVPs are regulated under various regulatory frameworks that apply to tobacco products, poisons, medicines and consumer products. There are established pathways for consumers to legally access unapproved NVPs, with a valid prescription. Further details about these pathways are provided below. However, it is important to note that unapproved medicines have not been assessed by the TGA for safety, quality and efficacy.
The recommended first-line smoking cessation support includes TGA-approved pharmacotherapies and behavioural support. NVPs may be considered with ongoing behavioural support for people who have tried to achieve smoking cessation with TGA-approved pharmacotherapies combined with behavioural intervention but failed and are still motivated to quit smoking.
Given there is not as yet a TGA-approved NVP, this guidance seeks to provide advice to clinicians on how to minimise risk to the person trying to quit smoking and society in general, and maximise benefit. The risks of NVPs include: , There is a lack of well conducted randomised controlled trials comparing NVPs with TGA-approved pharmacotherapies, such as bupropion and varenicline.
The review identified two randomised controlled trials that met inclusion criteria with a total of participants. The evidence from good quality randomised trials has not improved since the review conducted for the RACGP by the Joanna Briggs Institute in and there remains limited evidence that NVPs are an effective aid for quitting smoking compared with NRT or usual care.
The most commonly reported acute adverse effects in a recent Cochrane review were throat irritation, headache, cough and nausea. Based on the evidence, the EAG assessed the overall magnitude of acute adverse effects in the clinical setting as small but there may be other short-term effects that have not become evident. The effects of NVPs on other clinically important short- and long-term health outcomes are unknown. See the Appendix for the evidence-to-decision framework. Recommendation 15 — For people who have tried to achieve smoking cessation with first-line therapy combination of behavioural support and TGA-approved pharmacotherapy but failed and are still motivated to quit smoking, NVPs may be a reasonable intervention to recommend along with behavioural support.
However, this needs to be preceded by an evidence-informed shared-decision making process, whereby the patient is aware of the following caveats:. Use of the Personal Importation Scheme is not recommended to minimise the risk of the patient receiving imported products that do not meet the full TGO requirements.
Medical practitioners can choose to take the following steps to minimise the risk of patients using their prescription supplied under the Authorised Prescriber or Special Access Scheme to purchase NVPs through the Personal Importation Scheme:.
Note: NVPs are currently under consideration for inclusion in real-time prescription monitoring systems in Australia. The recommendations depend on whether the patient is new to using NVPs for smoking cessation or is an experienced user of NVPs. In addition, since different NVP brands have different nicotine concentrations, prescribers may have to specify product brands to reduce confusion or uncertainty during dispensing.
Therefore, prescribers will likely need to be aware of product availability. At the time of writing, the specific products that will be available in Australian pharmacies is not known. Besides consideration of open or closed systems, other issues to consider when choosing a product include certification of adherence to Good Manufacturing Practices and whether the manufacturer provides product liability insurance.
The EAG noted it is not possible to provide definitive advice on dosing as there is no clear evidence and no guidelines on dosing exist at this time. In addition, the dose of nicotine received by the person can vary by the type of vaping device including the electrical power of the device , concentration of nicotine, and inhalation technique.
There is currently only limited guidance from the literature on NVP dosing with the free-base nicotine. It is important to note that there are currently no trials of the efficacy of nicotine in salt form to assist smoking cessation. The higher-concentration nicotine salt have potential advantages and disadvantages. Potential advantages are that their pharmacokinetics more closely replicate nicotine from smoking, which may facilitate people transitioning away from combustible tobacco.
This has been a particular feature in countries with consumer availability such as the United States and Canada. While acknowledging the lack of evidence, the EAG provided the following suggestions to assist in making prescribing decisions:.
However, 1 in 8 cases are reported in use of nicotine-only products. Flavouring chemicals can reduce the harshness of nicotine, increase the appeal and reduce the perceived risk of NVPs. There is limited evidence about the long-term safety of inhaled flavourings. Flavouring chemicals may be safe to consume as food or medication but may not be safe to inhale. To minimise risk, the EAG strongly recommends the use of devices with closed systems as users cannot purchase and add their own flavours, and to avoid open systems.
NVPs are unregistered products and it is valid and reasonable for medical practitioners to choose not to prescribe them. Overseas nicotine vaping products are not required to meet all of the TGO requirements for safety. There is a lack of high-quality evidence for the use of NVPs in people with chronic illnesses. The risk of using NVPs needs to be weighed against the risk of long-term smoking in people who have not been able to quit with first-line treatments TGA-approved pharmacotherapies and behavioural support.
NVPs are not recommended in pregnant or breastfeeding women. NVPs are not approved for use in pregnancy and their effects on foetal development and obstetric outcomes are not known. For further information about smoking cessation in this population, refer to Chapter 4: Aboriginal and Torres Strait Islander peoples. The use of specific culturally safe resources, such as Tackling Indigenous Smoking and the Aboriginal Quitline is recommended.
Aboriginal and Torres Strait Islander people are more likely than non-Indigenous people to live in households with children present and to experience mental health illness. Particular care should therefore be taken to avoid prescription of high nicotine concentration liquids and open systems, and to advise on appropriate storage of NVPs, including keeping them out of reach of children.
Smoking is highly prevalent in people with mental illness, especially those with severe illness. If people with mental illness have not been able to quit with first line treatment, consideration of NVPs in combination with behavioural support may be of value, although evidence specific to this group is currently lacking. People with mental illness are likely to be at greater risk of intentional poisoning from NVPs.
Therefore, particular caution should be taken to avoid prescription of high nicotine concentration liquids and open systems. For further information about smoking cessation in this population, refer to Chapter 4: People with mental illness. As with any intervention for smoking cessation, follow-up visits to discuss progress and provide support is recommended.
Note that dose titration may be needed with regular follow-up and should be discussed with the patient. Encourage complete transition to NVPs and cessation of combustible tobacco. After this initial phase, it is reasonable to review at least every 3 months, which is consistent with prescribing of PBS-subsidised smoking cessation therapy. There is currently a lack of evidence about the optimal length of use or how to titrate NVPs down to achieve nicotine cessation.
A suggested approach would be to attempt weaning or cessation of NVPs after 12 weeks of use. Other approved smoking cessation pharmacotherapies may have a role; however, there is a need for further research. There is currently limited evidence for combination use involving NVPs.
Cessation of both tobacco smoking and use of other forms of nicotine is always the preferred option. However, there may be instances in selected patients where the doctor and patient agree that a longer term use of NVP is needed to avoid a relapse to tobacco use. Dual use should be avoided. If considering ongoing use of NVPs, counsel the patient on the risks and benefits versus re-trying other approved smoking cessation pharmacotherapies.
This discussion includes that the long-term safety of NVPs is unknown, that there is a lack of high quality evidence of the health benefit from a tobacco harm reduction approach using NVPs , and that people who use NVPs have an approximately double the risk of relapse to combustible tobacco smoking compared with non-NVP users. Based on a small number of trials, clonidine has been found to be more effective than placebo in promoting smoking cessation.
A number of other tobacco cessation therapies are available or in development, as described below. Cytisine is a naturally occurring substance, chemically related to varenicline, that has been used for smoking cessation for decades in parts of Eastern Europe. A Cochrane meta-analysis concludes that cytisine increases the chances of quitting, although absolute quit rates in two recent trials were modest. Anti-nicotine vaccines have been in development for a number of years.
The rationale for immunisation against nicotine is to induce antibodies that bind nicotine in the blood, thereby preventing it from crossing the blood—brain barrier.
The vaccines must be administered regularly to maintain long-term protection. Early pre-clinical trials evaluating different vaccines were encouraging, but to date no study has detected a statistically significant difference in long-term cessation between vaccines and placebo. Given that the current available first-line medications are all efficacious, and non-drug factors make a substantial contribution to the likelihood of quitting successfully, 8 choice should be based on overall evidence of relative efficacy, clinical suitability and patient preference Figure 2.
Did you know you can now log your CPD with a click of a button? Supporting smoking cessation: A guide for health professionals Chapter 2 Pharmacotherapy for smoking cessation. Table of contents About this guideline Introduction to smoking cessation Pharmacotherapy for smoking cessation Behavioural and advice-based support for smoking cessation Smoking cessation for high-prevalence groups Tobacco harm reduction.
Figures and tables Supplementary material Disclaimer Resources for health professionals Acknowledgements Recommendations Provided under licence. Recommendation 8 — a Nicotine replacement therapy NRT is safe to use in patients with stable cardiovascular disease.
Strong recommendation, high certainty b NRT should be used with caution in patients who have had a recent myocardial infarction, unstable angina, severe arrhythmias or recent cerebrovascular events. However, this needs to be preceded by an evidence-informed shared-decision making process, whereby the patient is aware of the following caveats: Due to the lack of available evidence, the long-term health effects of NVPs are unknown.
NVPs are not registered therapeutic goods in Australia and therefore their safety, efficacy and quality have not been established. There is a lack of uniformity in vaping devices and NVPs, which increases the uncertainties associated with their use. To maximise possible benefit and minimise risk of harms, dual use should be avoided and long-term use should be minimised.
It is important for the patient to return for regular review and monitoring. Conditional recommendation for intervention, low certainty. Key points Pharmacotherapy should be recommended to all people who smoke with nicotine dependence.
The most successful approach to quitting for people who smoke with nicotine dependence is behavioural support combined with first-line pharmacotherapy and follow-up. Nicotine replacement therapy NRT , varenicline and bupropion are licensed and available in Australia to assist smoking cessation. Varenicline is the most effective single-form pharmacotherapy for smoking cessation.
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They offers books from different platforms with different formats. You can type and search for your ideal book and find whether it is available in PDF. If so, you can download it for free. Click Here to Get eBooks. POLAR software is useful for insight and planning across the areas of clinical, business, quality improvement and accreditation for general practice.
It enables meaningful analysis by general practices of their own identified patient data, which is presented in an easy to use graphical format.
Data analysis is all about asking questions and and finding answers. POLAR is as open as possible in its structure aiming to help you find simple to complicated answers to questions specific to your general practice:.
Example question, ask POLAR, "how many of my regular patients who have a current diagnosis of diabetes have not had a car plan in the last 12 months"?
You can analyse your data to identify gaps in patient care, allocate resources and clinicians accordingly, and build on your clinical strengths including in the areas of quality improvement and safety.
Contact the Digital Health team at This email address is being protected from spambots. You need JavaScript enabled to view it. Step 1: Data Security and Privacy document - download and read.
Call us if you have any questions. Ask your ICT provider for assistance. Step 4: Attach your completed documents from Step 2 and Step 3 and email to This email address is being protected from spambots.
Step 5: A3 GP Poster option 1 for reception area or A3 GP Poster option 2 for reception area documents - download, print and display in your reception area - option 1 or option 2 - your choice. Call us and we can send you a printed version.
We provide software support for POLAR issues, updates, advice, requests, remote training, and documentation. POLAR access requires your practice users to have an individual user account. For example, under the Clinic Summary report, the practice principal and practice manager can see MBS items and numbers and revenue, while nurses can be restricted to seeing MBS items and numbers only and not MBS revenue. Details for setting up and managing accounts including resetting passwords are covered in the resources below.
Contact us if you need help setting up and managing your general practice's accounts, including restricting access. The guide provides information about the POLAR interface, the first steps, hints and tips, how to use filters, and troubleshooting.
POLAR has several important functions that are not always obvious to a user. We have outlined some of these important functions below. In the POLAR Mapping section of Confluence you will select your practice software and then be presented with information for that page including Definitions, Calculation and Logic, Source in clinical system, and screenshots showing where to enter patient data so that it can show up in POLAR.
Times format shown represents mm:ss and h:mm:ss. Filtering patient data in POLAR allows you to look for specific information about defined patient cohorts. Program lifeprogram. Contact us if you would like assistance with these walkthroughs, or would like us to create a new walkthrough. Create a bookmark. We have created ready-made and easy to use PDSA cycle templates to help you with ongoing quality improvement for common data items requiring regular tracking and management.
These templates break down the data quality improvement topics into manageable tasks, and have strategies to help implement, measure and manage process quality improvement. Why not have a look at the first PDSA cycle and give it a go don't forget to print off the corresponding Walkthrough. You will need to save your Patient List file as a.
Patient List. The patient ID number allows you to customise the message with the patient's name, and may automatically respect the patient's SMS opt-out preference. The following instructions will step you through uploading your Patient List. The following instructions will step you through uploading you Patient List. Data quality improvement QI means improving the quality of the data displayed in POLAR which is directly related to the quality of the data entered into your practice software.
The best option for benchmarking and tracking your practice's quality improvement over time while we wait for a POLAR snapshot-history function is to copy print screen keyboard button, or snipping software and paste screenshots of your POLAR pages into Microsoft Word documents, and save these to a centralised network folder called POLAR. Contact us if you would like assistance with your Quality Improvement benchmarking and tracking and Screenshots to Word.
POLAR is useful for insight and planning across clinical and business and accreditation for general practices of all sizes. Data can highlight differences in health status between social groups and can help determine what approaches need to be prioritised.
With advances in technology, general practices are able to capture and analyse health data more efficiently and without additional costs.
POLAR is suitable for use by all general practice staff, including practice principals, general practitioners, nurses, practice managers, business managers and admin staff.
POLAR performs a data collection extracts changed data from the practice software every five minutes. The identified and de-identified practice data is encrypted using industry endorsed algorithms similar as those used in the health, banking and e-commerce sectors.
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