2010 PHS Clinical Practice Guidelines: Smoking Cessation CDR Sherri Yoder PharmD, BCPS, CER Program Principal Consultant Indian Health Service USPHS COA Symposium: Pre-conference Workshop National Guidelines Update June 19, 2011

Overview  2010 Surgeon General’s Report: How Tobacco Smoke Causes Disease  Treating Tobacco Use and Dependence: 2008 Update  Decision Aids for Clinicians/Recommendations

Objectives To identify key conclusions in the 2010 Surgeon General Report on Smoking and Health To identify key pharmacologic and non- pharmacologic recommendations associated with smoking cessation therapy according to the 2008 Clinical Guidelines Update To identify clinician decision aids

2010 Surgeon General Report With each SG Report on smoking, beginning in 1964, –List of adverse health effects has gotten longer –Evidence has gotten stronger The latest report, #30 in a series, was published in 2010

Report Highlights There is no risk-free level of exposure to tobacco smoke. –There is no safe level of exposure. Tobacco smoke inhalation causes cancer, cardiovascular, and pulmonary disease. –Damage from smoke is immediate. Risk and severity are directly related to duration and level of exposure –Smoking longer means more damage.

Report Highlights Sustained use and long-term exposure are due to addictive effects. –Cigarettes are designed for addiction. Low levels of exposure, including secondhand smoke, can lead to cardiovascular events and thrombosis. –Any exposure to tobacco smoke, even an occasional cigarette or exposure to secondhand smoke, is harmful.

Report Highlights There is a lack of evidence that product modification strategies (lowering emissions, lowering nicotine) decrease risk. –There is no safe cigarette. ***************************************************** The only proven strategy for reducing the risk of tobacco-related disease and death is to never smoke, and if you do smoke to quit.

Tobacco Cessation/Prevention One of U.S. Public Health successes of the last 50 years due in part to a collaborative effort –Policymakers –Public health advocates –Clinicians

2008 Clinical Practice Guideline 257 pages 222 Powerpoint slides Available at: – – – se08.pdf

Guideline History Initial Revised – 2000Updated Literature from Literature from Literature from Approximately 3,000 articles Approximately 2,700 articles

Guideline Update Principle analytic technique used with this Guideline update was meta-analysis of RCTs

I never meta-analysis I liked A complete and detailed review of the meta-analytic methods used in the Guideline can be found in the Smoking Cessation Guideline Technical Report No. 18, available from the Agency for Healthcare Research and Quality (AHRQ) as AHCPR Publication No. 97-N004.

#1 Key Recommendation Tobacco dependence is a chronic disease that often requires repeated intervention and multiple attempts to quit. However, effective treatments exist that can significantly increase rates of long-term abstinence

#2 Key Recommendation It is essential that clinicians and healthcare delivery systems consistently identify and document tobacco use status and treat every tobacco user seen in a healthcare setting.

Clinician Training Programs from: –4 hour Basic Tobacco Intervention Skills Certification –5 day Intensive Tobacco Treatment Specialist Certification

#3 Key Recommendation Tobacco dependence treatments are effective across a broad range of populations. Clinicians should encourage every patient willing to make a quit attempt to use the counseling treatments and medications recommended in this Guideline.

#4 Key Recommendation Brief tobacco dependence treatment is effective. Clinicians should offer every patient who uses tobacco at least the brief treatments shown to be effective in this Guideline.

#5 Key Recommendation Individual, group and telephone counseling are effective and their effectiveness increases with treatment intensity. –Two components of counseling are especially effective and clinicians should use these when counseling patients making a quit attempt: Practical counseling (problem-solving/skills training) Social support delivered as part of treatment

#6 Key Recommendation There are numerous effective medications for tobacco dependence and clinicians should encourage their use by all patients attempting to quit smoking, except when medically contraindicated or with specific populations for which there is insufficient evidence of effectiveness (i.e., pregnant women, smokeless tobacco users, light smokers and adolescents).

#6 Key Recommendation Seven first-line medications reliably increase long-term smoking abstinence rates: –Bupropion SR –Varenicline –Nicotine gum –Nicotine inhaler –Nicotine lozenge –Nicotine nasal spray –Nicotine patch Clinicians should also consider the use of certain combinations of medications identified as effective in this Guideline.

Specific Populations each have their own sections of this Guideline update: –usually excluded from the RCTs used to evaluate the effectiveness of interventions presented in this Guideline –may have other special issues, for example, safety.

#7 Key Recommendation Counseling and medication are effective when used by themselves for treating tobacco dependence. However, the combination of counseling and medication is more effective than either alone. Thus, clinicians should encourage all individuals making a quit attempt to use both counseling and medication.

#8 Key Recommendation Telephone quitline counseling is effective with diverse populations and has broad reach. Therefore, clinicians and healthcare delivery systems should both ensure patient access to quitlines and promote quitline use.

#9 Key Recommendation If a tobacco user is currently unwilling to make a quit attempt, clinicians should use the motivational treatments shown in this Guideline to be effective in increasing future quit attempts.

#10 Key Recommendation Tobacco dependence treatments are both clinically effective and highly cost-effective relative to interventions for other clinical disorders. –Providing coverage for these treatments increases quit rates. –Insurers and purchasers should ensure that all insurance plans include the counseling and medication identified as effective in this Guideline as covered benefits.

Corrections & Additions to the PHS Guideline Addition #1 (posted 7/09) issued new warnings for both varenicline and bupriopion Correction #1 (posted 7/09): inaccurate number of study arms, but results were similar. Correction #2 (posted 11-09): Clinician guideline: smoking slips versus lapses. Corrections and Additions to the Public Health Service (PHS) Clinical Practice Guideline: Treating Tobacco Use and Dependence—2008 Update. Agency for Healthcare Research and Quality, Rockville, MD.

Decision Aids Quick Reference Guide for Clinicians 2008 Update –Presents summary points from the Guideline –Offers many recommendations for practitioners to adopt depending on available resources, clinical environment, and patient circumstances.

Quick Reference Guide –5 A’s (ask, advise, assess, assist, arrange) –Organized around 3 main groups of users Those willing to quit Those who are unwilling to quit now Those who recently quit –Enhancing motivation 5 R’s (relevance, risks, rewards, roadblocks, repetition)

New Recommendations Formats of Psychosocial Treatments Combining Counseling and Medication For Tobacco Users Not Willing to Quit Now Nicotine Lozenge Varenicline Specific Populations Light Smokers

Clinician Training Programs from: –4 hour Basic Tobacco Intervention Skills Certification –5 day Intensive Tobacco Treatment Specialist Certification –Important where billing is concerned Rural health centers (RHC) Federally qualified health centers (FQHC) Indian Health Service (IHS) Critical access hospitals (CAH)

Recommendations Websites (AHRQ, CDC, ACS) Know your state’s indoor air laws Know your quitline resources Keep up to date with FDA’s Center for Tobacco Products Be informed regarding novel tobacco products: e-cigs, dissolvable nicotine, true pulmonary nicotine inhalers, hookah use

Real Reasons Fear of failure Know the disadvantages but don’t understand them Fear of standing out: social pressure Comfortable with unhealthy lifestyle Not knowing how to quit

Questions?