Making Every Contact Count

Transcription

1 Making Every Contact Count Darush Attar-Zadeh BPharm MRPharmS This presentation is organised and funded by Pfizer Prescribing Information for Champix (varenicline tartrate) is available at this meeting Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Pfizer Ltd on MTGGIP30133a September 2015

2 Making every contact count By Darush Attar-Zadeh BPharm MRPharmS

3

4 Principles underlying treatment To keep the motivation not to smoke above the motivation to smoke at all times Maximise resolve: Not a puff rule Ex-smoker identity Social contract Personal satisfaction Resolve not to smoke Urge/need to smoke Minimise urge/need: Avoid cues Reduce physiological need Distraction/coping 4

5 Skin, Hair, Nails & Gums cosmetic benefits

6 Health Benefits

7

8

9 CO (ppm) % COHB 20 and above Heavy Smoker Smoker Light Smoker Non-Smoker

10 Why should we help people stop smoking?

11 SMOKING RELATED DEATHS IN ENGLAND (2011) Proportion of deaths estimated to be caused by smoking 1 1% Lung, trachea and bronchus cancer 6% 11% 12% 29% Other cancers COPD 23% 18% Pneumonia Ischaemic Heart Disease Other circulatory Digestive 1.

12 COPD Causes: Approximately 90 percent of COPD cases in the UK are caused by smoking tobacco Links with passive smoking and air pollution

13 Asthma & COPD

14

15 It only takes 30 seconds

16 Are you on any medication? Check PMR/Label PMR NMS, MUR Inhalers Antihypertensives Warfarin Diabetes Mental Health OTC Does anybody in your household smoke? Team Approach

17 Am J Health-Syst Pharm Vol 64 Sep 15, 2007

18 Pharmacotherapy in combination with intensive behavioural support gives the optimum chance of success 1 1. NHS. Local stop smoking services. Service delivery and monitoring guidance, 2011/ West R, et al. Thorax 2000;55: Hilton A. Prescriber 2003; February: Fowler G. Update 2000; May supplement:3 7.

19 Effectiveness Intervention Outcome NNT Statins Antihypertensive therapy Prevent one death over five years Prevent one stroke, myocardial infarction, death over one year Cervical cancer screening Prevent one death over 10 GP brief advice to stop smoking (< five minutes) years Prevent one premature death 80 Add pharmacological support Prevent one premature death Add behavioural support Prevent one premature death Successful quit attempt Prevent one premature death 2 darushattar@hotmail.com Note: For illustrative purposes only since NNTs across trials shouldn't theoretically be compared due to e.g. different study populations, trial lengths and outcomes. 19

20 Effectiveness of smoking cessation therapies The Cochrane review The Cochrane Collaboration is a well established, non-profit, independent organisation dedicated to making up-to-date and accurate information about the effects of healthcare interventions available 1 A Cochrane review assessed the efficacy and tolerability of nicotine receptor partial agonists, including varenicline, for smoking cessation 2 NNT to achieve additional successful quitter compared with placebo 2 All types of NRT 23 (95% CI 20-27) Bupropion 20 (95% CI 16-26) Varenicline 10 (95% CI 8-12) 1. The Cochrane database. Available at: Accessed May Cahill K, Stead LF, Lancaster T. Nicotine receptor partial agonists for smoking cessation. The Cochrane Database of Systematic Reviews 2011;Issue 2. [DOI: / CD pub5]..

21 The Importance of NHS Support & Medication [1] Cochrane Database of Systematic Reviews [2] Cochrane Database of Systematic Reviews Success rate at 4 weeks with no support or medication (16%) Best possible treatment outcome at 4 weeks (74%) Support & Medication

22 NICOTINE IS HIGHLY ADDICTIVE

23 Why is it hard for your patient to stop smoking? Short half life of nicotine requires smokers to regularly smoke to maintain levels 2 Reinforcing desired effects of nicotine with each cigarette soon becomes addictive 2 1. Russell MAH, et al. BMJ 1976; 1: Nicotine addiction in Britain: A report of the Tobacco Advisory Group of the Royal college of Physcians. London: Royal College of Physicians, 2000

24

25 Smoking makes stress worse!

26

27 Keep the message simple! Varenicline at the 4 2 receptor Partial agonist Binds with high affinity to the 4 2 receptor, only partially stimulating dopamine release 1 Provides relief from craving and withdrawal symptoms 1-3 Antagonist Prevents stimulation of the receptor by nicotine This reduces the pleasurable effects of smoking and potentially the risk of full relapse after a temporary lapse Coe JW. J Med Chem 2005; 48: Gonzales D et al. JAMA 2006; 296: Jorenby DE et al. JAMA 2006; 296: Foulds J. Int J Clin Pract 2006; 60:

28

29 What does equal 1 st line mean? Promoting Medications 8 forms of NRT (There is the patch, gum...) 2 Non Nicotine Treatments Varenicline & Buproprion There are 2 Non- Nicotine treatments Varenicline & Buproprion. Also there are 8 NRT products (patch, gum...) Varenicline works by... What treatments have you heard about? Have you tried anything in the past?

30 DOSING OF VARENICLINE

31 Varenicline (Champix) Contraindications Allergy to varenicline or excipients Not licensed for use in people under 18 Pregnancy & Breast feeding Champix should not be used during pregnancy. Breast feeding: Decision based on consideration of benefit of breastfeeding to the child and benefit of CHAMPIX therapy to the mother Special populations Renal impairment: Mild: No dosage adjustment necessary Moderate; No dosage adjustment necessary unless intolerable adverse event symptoms experienced (reduce dose to 1mg/day) Severe: Reduce dose to 1mg/day End Stage Renal Disease: Not recommended CHAMPIX Summary of Product Characteristics June 23 rd Accessed September 2015

32 Special warnings and precautions for use Changes in behaviour or thinking, anxiety, psychosis, mood swings, aggressive behaviour, depression, suicidal ideation and behaviour and suicide attempts have been reported in patients attempting to quit smoking with CHAMPIX in the post-marketing experience. 1 Clinicians should be aware of the possible emergence of significant depressive symptomatology in patients undergoing a smoking cessation attempt, and should advise patients accordingly. CHAMPIX should be discontinued immediately if agitation, depressed mood or changes in behaviour or thinking that are of concern to you, your patient, their family or their caregivers are observed, or if the patient develops suicidal ideation or suicidal behaviour. 1 Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nicotine withdrawal. In addition, smoking cessation, with or without pharmacotherapy, has been associated with exacerbation of underlying psychiatric illness (e.g. depression). Since the initial reports of serious neuropsychiatric events emerged, analyses of pooled clinical trial data and independent observational data have been conducted (See section 5.1). Patients taking CHAMPIX should be instructed to notify their doctor of new or worsening cardiovascular symptoms and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke 1 CHAMPIX smoking cessation studies have provided data in patients with major depressive disorder and limited data in patients with stable schizophrenia or schizoaffective disorder (see section 5.1). Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly. 1 At the end of treatment, discontinuation of CHAMPIX was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients. The prescriber should inform the patient accordingly and discuss or consider the need for dose tapering #CHAMPIX Summary of Product Characteristics June 23 rd Accessed September 2015

33 Side effects Very common adverse events (incidence 10%) associated with varenicline 2 Nausea 32.0% Insomnia 19.1% Headache 17.7% Abnormal dreams 13.8% Nasopharyngits 10.7% 3 CHAMPIX has low discontinuation rates due to adverse events, comparable to placebo (11.4% vs. 9.7% ) 1 Nausea is mostly mild to moderate, occurs early in treatment and infrequently results in discontinuation 1 Based on varenicline characteristics and clinical experience to date, varenicline has no clinically meaningful drug interactions 1 In general when adverse event (AE) reactions occurred, onset was in the first week of therapy, severity was generally mild to moderate Patients who cannot tolerate AEs of CHAMPIX may have the dose lowered temporarily or permanently to 0.5mg twice daily 1 1. CHAMPIX. Summary of Product Characteristics. Pfizer Ltd. 2. European Public Assessment Report (EPAR). CHAMPIX: Scientific discussion. Available at:

34 CHAMPIX in patients with a history of Major Depressive Disorder (MDD) Double-blind, placebo-controlled, randomised (1:1), multicentre study assessing the efficacy and safety of CHAMPIX in MDD At baseline over 70% of patients were taking antidepressant medication Robert M. Anthenelli, et al., Ann Intern Med. 2013;159(6):

35 CHAMPIX in patients with a history of Major Depressive Disorder (MDD) Primary endpoint: Continuous abstinence rate (CAR) for weeks 9 12, CO-confirmed ( 10 ppm) Key secondary endpoints: CAR for weeks 9 24 and 9 52, CO-confirmed ( 10 ppm) All adverse events were recorded and an additional semi-structured interview was used to actively solicit reporting on neuropsychiatric events of special interest Other outcomes included depressive and anxiety related symptoms which were measured by psychiatric rating scales (MADRS and HAM-A respectively) Robert M. Anthenelli, et al., Ann Intern Med. 2013;159(6):

36 CHAMPIX in patients with a history of Major Depressive Disorder (MDD) 525 smokers (average ~22 cigs/day for past month and ~26.5 years smoking), aged with a history of Major Depressive Disorder and motivated to stop smoking DSM-IV-TR validated unipolar MDD, without psychotic features WITH AT LEAST ONE OF THE FOLLOWING Stable antidepressant treatment for MDD ( 2 months) Major depressive episode successfully treated in the past 2 years Robert M. Anthenelli, et al., Ann Intern Med. 2013;159(6):

37 Efficacy Outcomes Weeks 9-12: CO-confirmed ( 10ppm) Continuous Abstinence Rate (CAR) Quitting smoking at 12 weeks (35.9% vs. 15.6%; OR=3.35; 95% CI: 2.16,5.21; p<0.0001) Remaining abstinent at 1 year (20.3% vs. 10.4%; OR=2.36; 95% Cl: 1.40, 3.98; p=0.0011) Adapted from Anthenelli RM et al. Double-blind, placebo-controlled, randomised trial to assess efficacy and safety of CHAMPIX versus placebo in 525 smokers (aged years) with a past or present diagnosis of DSM-IV-TR validated unipolar MDD; without psychotic features and either on stable antidepressant treatment for MDD ( 2 months) and/or with a successfully treated episode of MDD in the past 2 years. Primary endpoint: Continuous abstinence rate (CAR), confirmed by exhaled carbon monoxide (CO) 10 ppm, between weeks 9 and 12. Key secondary endpoints: CO-confirmed CAR (<10ppm) for weeks 9-24 and weeks This study provides CHAMPIX data in patients with major depressive disorder. Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly Robert M. Anthenelli, et al., Ann Intern Med. 2013;159(6):

38 CHAMPIX was generally well tolerated in patients with a history of Major Depressive Disorder Most commonly reported adverse events ( 10% of subjects): CHAMPIX placebo Nausea 27.0% 10.4% Headaches 16.8% 11.2% Abnormal dreams 11.3% 8.2% CHAMPIX was generally well tolerated with a common adverse event profile similar to that observed in smokers without psychiatric disorders Irritability 10.9% 8.2% Insomnia 10.9% 4.8% Depression rating scales did not reveal any clinically significant deterioration in mood or anxiety in either treatment group Psychiatric SAEs occurred in 2 CHAMPIX patients and 4 placebo patients Robert M. Anthenelli, et al., Ann Intern Med. 2013;159(6):

39 Stopping Smoking & Depression Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nicotine withdrawal. In addition, smoking cessation, with or without pharmacotherapy, has been associated with exacerbation of underlying psychiatric illness (e.g. depression).

40

41

42

43 THIN database study: Evaluation of CHAMPIX as an aid to smoking cessation in UK general practice Study design: This retrospective cohort analysis of smokers who had received at least one CHAMPIX prescription investigated continuous abstinence based on self-reporting in the 7-day period at 6 months from treatment initiation Primary endpoint: Rate of smoking cessation, defined as the 7-day point prevalence after 6 months from starting CHAMPIX Results: Overall smoking cessation rate was 49.5% Patients who took CHAMPIX for 9 12 weeks had 11x greater odds of stopping smoking than those who completed <2 weeks treatment (OR=11, 95% CI: ) 1. Blak BT et al. CMRO 2010; 26 (4):

44 Behavioural support: effectiveness Percent increase in success Face-to-face individual Face-to-face group Pro-active telephone Text messaging Data from Cochrane reviews; bars represent 95% CIs based on rate differences versus brief advice/written materials/no treatment 44 44

45 Selling your service Summary FREE We have helped lots of people stop smoking, in fact we are on a roll lately! (4x more likely) We offer effective medications, lots of options available (heavily subsidised by the NHS) CO machine motivational aid Wheels, booklets Flexible (Text, , phone & face to face sessions)

46 Behaviour change

47 General principles involved in decision making 1) Current circumstances Is it the right time? Lots going on at the moment Stress in my life etc

48 General principles involved in 2) Past experiences decision making I ve had so many attempts, I just can t do it! No will power

49 General principles involved in decision making 3) Other people s beliefs Weight: My parent s always said that I should eat everything on my plate. Smoker: My family don t think I can do it. There s so much pressure to stop!

50 General principles involved in decision making 4) Level of support that can be accessed GP/Nurse Dietician Pharmacist Weight watchers Cost???? Smoking cessation, health checks FREE!

51 Scaling questions On a scale of 1 10 (1 being low motivation), how keen are you to stop smoking? 5 out of 10 Why is not a 1? (reasons to stop smoking) What will need to happen to move it from a 5 to 6? (positive steps to go about it)

52 We can all make mistakes, we are human after all Dealing with lapses or blips - Ambivalence explore verbally or on paper - Acceptance - Strategies to assist client in moving forward to achieve goal (CBT) Provide ongoing support - Providing follow up - Review goals and action plans

53 Rapport building Retaining clients Elicit Client Views Listen... Build Rapport Ask Questions... Reflective Listening Provide Reassurance Feedback... Summarise

54 Listen Non Judgemental Bus driver Cat Cigarettes & son Father and sons soother Self Censoring» I m a little embarrassed to tell you about my alcohol or drugs intake

55 Ask Open Questions Thought provoking? Exploring?» What have you already tried?» What have other people suggested?» What has worked for you in the past?» What healthy foods do you enjoy eating?» What physical activities do you enjoy, as it can lessen cravings?» What did you eat?» When?» How often?» How can I help you?» How much weight would you like to lose?» Are there times when you might eat less? E.g. When busy

56 Brief Interventions OARS Open-ended questions Affirmations (positive statements) Reflective listening Summaries Questions Tell me about the good things and the not so good things about? Tell me about a typical day in relation to? What would you like to achieve? What do you need to know from me? So what are you going to do?

57 I m really worried about my weight How rapport can be lost: Just eat healthily, have some carrot sticks and drink plenty of water. Try your best to avoid alcohol as this will pile on the calories Why don t you join the gym and maybe take up some yoga classes?

58 Yes but... I tried that already... I can t do that because... What is most likely to make someone change, an idea they have thought of themselves, or something you suggest?

59 I m really worried about putting on more weight Helpful responses: How would putting on more weight change your life? How much weight do you need to put on for it to be of concern? Do the BMI results concern you in anyway? Would you like some suggestions from me on how to avoid weight gain? Have you made any other changes in your life? How did you manage them?

60 Bad consultation

61 Adjusting good ideas - Partnership 1. What do you think you can do to live a healthier life style? 2. Is there anything getting in your way? 3. You mentioned earlier that snacking in between meals was a problem, what has worked for you in these situations? Not sure, have you got any ideas on what I can do? What some people do is start some physical activities bit by bit. These are the choices that are available... One of my clients earlier found having carrot & celery sticks to snack on was helpful. It s important you find what s right for you... Eating at different times, avoiding tea etc

62 Have you ever gone on a diet? No How do you know what I m going through then!? Lots of my patients have successfully reduced their weight with the right support... The We word... Team effort/partnership

63 Reflective listening Summarise goals Feedback Greater Rapport & Trust» So you mentioned that you enjoy certain vegetables» You mentioned the one in the morning was hard with a tea, as a non-smoker how do you think you can help yourself?» Let me get this right your main goal is to reduce your cigarette intake have you tried this method before?» Check understanding at the end, as they may have misunderstood Extra thought

64 Don t Assume A Person Has Understood Your Advice!

65

66

67 Guidance Be open to electronic cigarette use in people keen to try them, especially in those who have tried and failed using other aids Provide advice to clients

68 Summary (Losing Rapport) Why don't you stop talking! Please do some more reading after this session! You must pass the NCSCT vba assessment Don t think about a pink elephant!