Making Every Contact Count Darush Attar-Zadeh BPharm MRPharmS This - - PowerPoint PPT Presentation

Making Every Contact Count

MTGGIP30133a September 2015

Prescribing Information for Champix(varenicline tartrate) is available at this meeting

Darush Attar-Zadeh

BPharm MRPharmS

This presentation is organised and funded by Pfizer

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Pfizer Ltd on 01304 616161.

Making every contact count

By Darush Attar-Zadeh BPharm MRPharmS darushattar@hotmail.com

4

Principles underlying treatment

Resolve not to smoke Urge/need to smoke

Maximise resolve: ‘Not a puff rule’ Ex-smoker identity Social contract Personal satisfaction Minimise urge/need: Avoid cues Reduce physiological need Distraction/coping

To keep the motivation not to smoke above the motivation to smoke at all times

Skin, Hair, Nails & Gums – cosmetic benefits

Health Benefits

CO (ppm ppm) % COHB 20 and above 3.20+ Heavy vy Smoker 20 20 3.20 19 19 3.04 18 18 2.88 17 17 2.72 16 16 2.56 15 15 2.40 Smoker 14 14 2.24 13 13 2.08 12 12 1.92 11 11 1.76 10 10 1.60 9 1.44 Light Smoker 8 1.28 7 1.12 6 0.96 5 0.80 4 0.64 Non-Smoker 3 0.48 2 0.32 1 0.16

Why should we help people stop smoking?

Proportion of deaths estimated to be caused by smoking1

SMOKING RELATED DEATHS IN ENGLAND (2011)

29% 18% 23% 6% 11% 12% 1% Lung, trachea and bronchus cancer Other cancers COPD Pneumonia Ischaemic Heart Disease Other circulatory Digestive

• 1. http://ash.org.uk/files/documents/ASH_107.pdf

COPD Causes:

• Approximately 90 percent of COPD cases in

the UK are caused by smoking tobacco

• Links with passive smoking and air pollution

Asthma & COPD

It only takes 30 seconds

Team Approach

Does anybody in your household smoke?

NMS, MUR Inhalers Antihypertensives Warfarin Diabetes Mental Health

Are you on any medication? Check PMR/Label

OTC PMR

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

• Pharmacotherapy in combination with intensive behavioural

support gives the optimum chance of success1

1.

• NHS. Local stop smoking services. Service delivery and monitoring guidance, 2011/12.

3 2. West R, et al. Thorax 2000;55:987─999. 3. Hilton A. Prescriber 2003; February:14─20. 4. Fowler G. Update 2000; May supplement:3─7.

.

Effectiveness

Intervention Outcome NNT Statins Prevent one death over five years 107 Antihypertensive therapy Prevent one stroke, myocardial infarction, death over one year 700 Cervical cancer screening Prevent one death over 10 years 1140 GP brief advice to stop smoking (< five minutes) Prevent one premature death 80 Add pharmacological support Prevent one premature death 38 - 56 Add behavioural support Prevent one premature death 16 - 40 Successful quit attempt Prevent one premature death 2

19 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.

• 1. The Cochrane database. Available at: www.cochrane.org/about-us. Accessed May 2011. 2. Cahill K, Stead LF, Lancaster T. Nicotine receptor

partial agonists for smoking cessation. The Cochrane Database of Systematic Reviews 2011;Issue 2. [DOI: 10.1002/14651858.CD006103. pub5]..

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 available1

• A Cochrane review assessed the efficacy and tolerability of nicotine

receptor partial agonists, including varenicline, for smoking cessation2

NNT to achieve additional successful quitter compared with placebo2

All types of NRT 23 (95% CI 20-27) Bupropion 20 (95% CI 16-26) Varenicline 10 (95% CI 8-12)

Best possible treatment

• utcome at 4 weeks

(74%) Support & Medication Success rate at 4 weeks with no support or medication (16%)

The Importance of NHS Support & Medication

[1] Cochrane Database of Systematic Reviews [2] Cochrane Database of Systematic Reviews

NICOTINE IS HIGHLY ADDICTIVE

Why is it hard for your patient to stop smoking?

• Short half life of nicotine requires smokers to regularly smoke to maintain levels2
• Reinforcing desired effects of nicotine with each cigarette soon becomes addictive2

1. Russell MAH, et al. BMJ 1976; 1:1043-1046 2. Nicotine addiction in Britain: A report of the Tobacco Advisory Group of the Royal college of Physcians. London: Royal College of Physicians, 2000

dattar-zadeh@nhs.net 07961393032

Smoking makes stress worse!

Partial agonist

• Binds with high affinity to the 42

receptor, only partially stimulating dopamine release1

• Provides relief from craving and

withdrawal symptoms1-3

• 1. Coe JW. J Med Chem 2005; 48:3474-3477. 2. Gonzales D et al. JAMA 2006; 296:47-55. 3. Jorenby DE et al. JAMA 2006; 296:56-63. 4. Foulds J. Int J Clin Pract 2006; 60:571-576.

Antagonist

• Prevents stimulation of the receptor

by nicotine

• This reduces the pleasurable effects
• f smoking and potentially the risk of

full relapse after a temporary lapse1-4

Varenicline at the 42 receptor

Keep the message simple!

What does equal 1st 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?

DOSING OF VARENICLINE

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 breast-

feeding 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 23rd 2015. Accessed September 2015

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

• bserved, 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 stroke1

• 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 23rd 2015. Accessed September 2015

Side effects

• 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 discontinuation1

• Based on varenicline characteristics and clinical experience to date, varenicline has

no clinically meaningful drug interactions1

• 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 daily1

• 1. CHAMPIX. Summary of Product Characteristics. Pfizer Ltd. 2. European Public Assessment Report (EPAR). CHAMPIX: Scientific discussion.

Available at: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000699/WC500025254.pdf.

Very common adverse events (incidence ≥10%) associated with varenicline2 Nausea 32.0% Insomnia 19.1% Headache 17.7% Abnormal dreams 13.8% Nasopharyngits 10.7%3

CHAMPIX in patients with a history of Major Depressive Disorder (MDD)

– At baseline over 70% of patients were taking antidepressant medication

Double-blind, placebo-controlled, randomised (1:1), multicentre study assessing the efficacy and safety of CHAMPIX in MDD

Robert M. Anthenelli , et al., Ann Intern Med. 2013;159(6):390-400.

• 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)

CHAMPIX in patients with a history of Major Depressive Disorder (MDD)

Robert M. Anthenelli , et al., Ann Intern Med. 2013;159(6):390-400.

525 smokers (average ~22 cigs/day for past month and ~26.5 years smoking), aged 18-75 with a history of Major Depressive Disorder and motivated to stop smoking DSM-IV-TR validated unipolar MDD, without psychotic features Stable antidepressant treatment for MDD (≥2 months) Major depressive episode successfully treated in the past 2 years WITH AT LEAST ONE OF THE FOLLOWING

CHAMPIX in patients with a history of Major Depressive Disorder (MDD)

Robert M. Anthenelli , et al., Ann Intern Med. 2013;159(6):390-400.

Efficacy Outcomes

– 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)

Weeks 9-12: CO-confirmed (≤ 10ppm) Continuous Abstinence Rate (CAR)

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 18-75 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 9-52 22

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):390-400.

CHAMPIX was generally well tolerated in patients with a history of Major Depressive Disorder

– 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

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% Irritability 10.9% 8.2% Insomnia 10.9% 4.8%

CHAMPIX was generally well tolerated with a common adverse event profile similar to that observed in smokers without psychiatric disorders

Robert M. Anthenelli , et al., Ann Intern Med. 2013;159(6):390-400.

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).

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

• dds of stopping smoking than those who completed <2 weeks

treatment (OR=11, 95% CI: 3.9–31.1)

• 1. Blak BT et al. CMRO 2010; 26 (4): 861–870.

44

44

Behavioural support: effectiveness

1 2 3 4 5 6 7 8 9 10

Face-to-face individual Face-to-face group Pro-active telephone Text messaging Percent increase in success

Data from Cochrane reviews; bars represent 95% CIs based on rate differences versus brief advice/written materials/no treatment

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, email, phone & face to face

sessions)

Behaviour change

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

General principles involved in decision making

2) Past experiences – I’ve had so many attempts, I just can’t do it! No will power

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!

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!

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)

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

Listen.... Ask Questions..... Feedback....

Build Rapport Elicit Client Views

Reflective Listening Provide Reassurance

Summarise

Rapport building Retaining clients

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

Ask Open Questions

• Thought provoking?

» 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?

• Exploring?

» 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

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?”

“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?

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?

“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?

Bad consultation

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

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

Feedback

• Reflective listening

» 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?

• Summarise goals

» Check understanding at the end, as they may have misunderstood

Greater Rapport & Trust Extra thought

Don’t Assume A Person Has Understood Your Advice!

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

http://www.ncsct.co.uk/usr/pub/e-cigarette_briefing.pdf

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!