APNC Conference April 16, 2015 Federal, State and Local Level In - - PowerPoint PPT Presentation

Jim D. Martin, M.S. Director of Policy and Programs NC Tobacco Prevention and Control Branch NC Division of Public Health

APNC Conference April 16, 2015

Federal, State and Local Level

• In 2008, FDA attempted to regulate e-cigarettes

as a drug or drug delivery device under the Federal Food, Drug, and Cosmetic Act (FDCA); blocked shipment of e-cigarettes into the US.

• In 2009, Sottera, distributor of NJOY e-cigarettes,

sued for an injunction to allow the entry of their e-cigarettes, claiming that e-cigarettes cannot be regulated under the FDCA.

• Federal courts ruled that e-cigarettes cannot be

regulated as a drug or drug delivery device, but FDA had authority to regulate e-cigarettes as “tobacco products”.

Provides FDA authority to regulate:

 cigarettes,  cigarette tobacco,  roll-your-own tobacco,  smokeless tobacco, and  any other tobacco products that the Agency by

regulation deems to be subject to the law.

Image Source: whitehouse.gov

• Require disclosure of ingredients and

documents related to health

• Prohibit the introduction of new or changed

products without prior FDA review

• Prohibit manufacturers from claiming a

tobacco product is less harmful or will expose a consumer to fewer harmful substances without first providing the FDA with scientific evidence

• Authorize the FDA to set standards governing

the content of tobacco products.

 Ban flavorings in cigars or e-cigarettes

that may appeal to youth or curtail any

• f the marketing for e-cigarettes.

 Restrict marketing that appeals to kids.  Require packaging for e-cigarettes that

addresses the recent surge in nicotine poisoning cases related to e-cigarettes.

 Restrictions on online sales

 Whether all cigars should be regulated

equally

 Entire proposal was subject to public

comments ending August 2014.

 FDA collected input around the regulation

issue and comments from organizations or individuals who support the regulation as written or would suggest changes to either strengthen or weaken the proposed rule.

Image Source: Ajai Raj/Business Insider

 E-cigarettes are not currently regulated by the

FDA.

 States have the authority to take action to

prevent youth e-cigarette use, and many are doing so.

• Regulations:

 Sale  Marketing  Price  Use  Packaging

 The NCGA passed Senate Bill

530 / S.L. 2013-165 in 2013 to prohibit e-cigarette sales to minors.

 This law defines e-cigarettes as

“tobacco products” and includes in the definition any product that contains tobacco and is intended for human consumption.

 Since August 2008, G.S. 115C-407 has required

that every North Carolina school district have a written 100% tobacco-free school policy that prohibits the use of all tobacco products on campus and at school-related events for students, staff and visitors at all times.

 Covers all “tobacco products”, which means

that e-cigarettes are included within that definition.

 The 2014 NC General Assembly

passed a new tax of 5 cents per milliliter of e-liquid.

 The tax goes into effect June 1, 2015

Source: Carolinas Poison Center, 2015

20 40 60 80 100 120 140 160 2011 2012 2013 2014

E-ciga cigaret rette, te, liqui uid nicot

• tin

ine e expos

• sures

res Year

Exposur ures to Electr tronic

• nic Cigarettes

rettes and/or r Liquid d Nicoti tine ne Reporte ted to the the Carol

• lin

inas as Poison Center ter

 SE

SENA NATE TE BI BILL L 286 286: Re Regu gulate ate the e Sa Sale e of E- Liquid uid Container iners

 Sponsors: Senators Bingham, D. Davis

(Primary Sponsors); Bryant and Waddell

 Referred to: Rules and Operations of the

Senate on March 16, 2015

 BILL TO BE ENTITLED: AN ACT PROHIBITING

THE SALE OF E-LIQUID CONTAINERS WITHOUT CHILD-RESISTANT PACKAGING AND SAFETY WARNING LABELS.

Findings:

• Reduces exposure to secondhand smoke
• Reduces the prevalence of tobacco use
• Increases the number of tobacco users who quit
• Reduces the initiation of tobacco use among young

people

• Reduces tobacco-related morbidity and mortality,

including acute cardiovascular events

• Economic evidence indicates that smoke-free

policies can reduce healthcare costs substantially.



Source: CDC Community Guide 2014.

 Air containing electronic nicotine delivery systems

(ENDS) aerosol is less safe than clean air, and ENDS use has the potential to involuntarily expose children adolescents, pregnant women, and non- users to aerosolized nicotine, toxic substances and, if the products are altered, to other psychoactive substances.

 Therefore, clean air—free of both smoke and

ENDS aerosol—remains the standard to protect health.

Source: Letter from Tim McAfee, MD, MPH, Director, Office on Smoking and Health, Centers for Disease Control and Prevention, March 2015

 G.S. 14-313

“To ensure uniformity, no political subdivisions, boards, or agencies of the State nor any county, city, municipality, municipal corporation, town, township, village, nor any department or agency thereof, may enact ordinances, rules or regulations concerning the sale, distribut bution, ion, display y or promotion tion of (i) tobacco products or cigarette wrapping papers on or after September 1, 1995, or (ii) tobacco-derived products or vapor products on

• r after August 1, 2013.

 The NC General Assembly has never passed

legislation preempting local governments from regulating the use of e-cigarettes (or smokeless forms of tobacco), which are not lighted.

 Therefore, local governments can pass such

regulations under their basic authority to pass regulations to protect the health and welfare of the community.

 If a regulation for government buildings and/or

grounds covers all “tobacco products”, then our interpretation is that e-cigarettes are included within that definition.

 Guidance from the UNC School of Government,

http://canons.sog.unc.edu/?p=7788

Counties Municipalities

 Catawba  Beaufort  New Hanover  Transylvania  Hyde  Pender  Rutherford  Pitt  Mecklenburg  Haywood  Brookford  Chapel Hill  Catawba  Saluda  Wilmington

Source: Information compiled from ongoing reporting and documentation collected by the NC Tobacco Prevention and Control Branch. Updated April ril 2015.

Progress in Tobacco-free Environments in North Carolina

Commun unity ty Coll lleges eges Community Colleges may prohibit smoking and all tobacco product use in their buildings and on their grounds. (Currently, 37 of 58 community colleges have tobacco-free campus policies) Publi lic Schoo

• ols

ls K-12 12 State law requires local boards of education to adopt policies prohibiting the use of tobacco at all times:

• In school buildings,
• In school facilities,
• On school campuses,
• In or on any other property owned by the local

school administrative unit, and

• At school-sponsored events at other locations

when in the presence of students or school personnel. Hosp spitals tals ALL 127 acute care hospitals in North Carolina have a 100% tobacco-free campus wide policy.

• Community hospital behavioral

health units means more consumers treated in tobacco-free environments State te Opera rated ted Healt lthc hcare re Faci cili liti ties es

• All 14 State Operated Mental Health,

Developmental , Alcohol and Drug Abuse Treatment Centers have a 100% tobacco-free campus wide policy Pris ison

• ns

State law prohibits any person from using tobacco products inside or on the grounds of a state correctional

• facility. There may be an exception for

authorized religious purposes.

 Tobacco use is the #1 preventable cause of death and

disease in NC and the nation

 Persons with behavioral health disorders smoke at

disproportionally higher rates, and are at greater health risk than the general population

 This population suffers from a 20% reduction in life

span in part due to tobacco-related diseases. (NASMHPD, 2007)

 Both the National Association of State Mental Health

Program Directors and American Psychiatric Association recommend that psychiatric facilities implement tobacco-free policies to encourage their consumers to quit smoking.

 Increased tobacco cessation for staff and

consumers

 Increased employee productivity  Reduced employee absenteeism from illness  Reduced medical expenses  Reduced health care costs for State Health

Plan

 Reduced medication costs for consumers

 Tobacco-free policies at behavioral health

facilities (in-patient and out-patient) benefit both staff and consumers.

 Helping individuals served achieve a healthier

lifestyle

 Protections:

• Secondhand smoke and e-cigarette aerosol

elimination

• Injury prevention
• Verbal aggression can decline significantly
• Cleaner environment

 2011 survey – 75% of state psychiatric facilities were

non-smoking campus-wide

 Hospitals that prohibit smoking are more likely to

actively promote and educate patients about the risk of smoking

 35% that permit smoking expect to further limit

smoking access

 State Quitlines are being increasingly used by tobacco

free hospitals in discharge planning to help patients stay tobacco free as they return home.



Schacht, L., Ortiz, G, and Lane, Jr., G.M. (2012, April). Smoking policies and practices in state psychiatric facilities: Survey results from 2011. Falls Church, VA: National Association of State Mental Health Program Directors Research Institute, Inc. (NRI).

 As of July 6, 2009, ALL acute care hospitals in

North Carolina have a 100% tobacco-free campus wide policy!

 As of July 1, 2014, ALL State Operated Health Care

Facilities in North Carolina have a 100% tobacco- free campus wide policy!

 Two successful tobacco-free pilots!—Broughton

Hospital and Walter B. Jones ADATC

 More consumers are being discharged already

abstinent

*

 Implement policies across the board, for

staff and patients

 Provide both staff and patients with

cessation assistance, including nicotine replacement therapy

 Handle consumer violations of the policy as

a treatment issue

 Handle staff violations as a personnel issue

 Policy covers visitors  Include in the policy information about off-

site use, such as home visits or off campus activities

 Ensuring Adequate Preparation  Communication, Communication,

Communication

 Gaining Visible Champions  Developing a Plan for Change  Adopting a System-based Approach to

Address Tobacco Cessation

 Implementing and Evaluating

• Ideally allow 6-12 months to prepare before

implementation

• Make sure that the health administrators,

human resource staff, facility staff, consumers, family members, law enforcement and security staff and the community are adequately prepared

• Engage these groups and find champions to

help implement

 During this time of initial planning:

 Encounter both support and

• pposition

 Respect concerns and discuss benefits of the policy  Stay positive, promote wellness and recovery  Recruit champions to be visible

 Develop the key messages, such as:

• People with serious mental health illness die 25

years younger than the general public largely due to smoking

• Tobacco use can interfere with psychiatric

medications

• Most tobacco users want to quit and need

assistance with their addiction

• 60% of NC tobacco users in NC made a serious

attempt to quit in 2010

• Pharmacotherapy and behavioral therapy combined

can increase successful quitting

• A tobacco-free campus promotes an on-going

healthier setting

 “We are developing this policy to provide a

healthy and safe environment for employees, patients, and visitors and to promote positive health behaviors.”

 “Tobacco use acts as a cue for other drug use

and maintains a drug-related coping style.”

• Health administrators
• Human resource staff
• Facility staff
• Consumers
• Family members
• Law enforcement and security staff
• Community
• State officials and decision-makers

 Top Administration  Clinical Leadership  Clinicians  Staff  Consumers  Family members  Public

Image Source: Photos.com

 Develop a 6 to 12 month timetable  Establish a Leadership group and create a

task force for implementation

 Gather information on the level of support  Create clear policy language  Offer cessation assistance  Announce the policy and implementation

plan between 6 and 9 months out

 Educate key stakeholder groups

 Communicate the Policy using multiple

strategies

 Conduct training(s) for facility and staff  Post signage  Celebrate on the effective date, but also gain

compliance on day one.

 Regular communication and evaluation post

enactment

 Most folks comply with policies provi

vided ded they know those policies exist

 Public awareness before they come on

campus is key

 If they violate the policy, what do you do?

Politely remind them.

WE ARE

Thank you for not using tobacco products on

• ur campus.

Tobacco free for your health!

(

This is a compliance aid. It is designed to help your

• rganization implement a

smoke-free building and grounds policy. Customize it to meet your

• needs. Add YOUR logo.

Print it pocket size or poster size. Empower formal and informal leaders in your

• rganization to use it!

If you wa want to quit smoking

• r using smokeles

ess s tobacco, call QuitlineNC at 1 1-800 800- QUIT-NOW (1-800 800-784 784- 8669) or visit, , www.QuitlineN eNC.com

• m for

informati tion

• n.

QuitlineN eNC.com

• m is FREE,

confiden dentia tial and a accessibl ble e 24 hours a day, 7 d days a week. . (add your organization’s logo)

 Staff

ff—polite reminders, failure to adhere leads to disciplinary action

 Pa

Patien ents ts—non-compliance is a treatment issue to be addressed by the treatment team

 Visitors

tors--polite reminders; failure to comply

• r unruly refusal may be reported to local

security

 Following the key steps for implementation

will ensure success.

 Monitor the compliance  Post regular announcements reminding

people of the tobacco-free policy

 Offer evidence based tobacco treatment and

support for tobacco users who want to quit

 Train staff in the clinical and psychosocial

elements of tobacco use.

 Assess tobacco use for all patients  Provider reminder systems (like vital signs

documentation) are especially effective when combined with provider training

 Assimilate tobacco dependency treatment

into patient treatment plan

 Provide intervention to all tobacco users

motivated to quit

• Incorporate tobacco treatment into

individual and group therapy

• Include prescription and OTC FDA

approved medications

• Document tobacco use and intervention

in charts

• Include tobacco cessation/relapse

prevention support upon discharge

AS ASK

5 A’s Brief Interventi rvention

• n

 Optimizing behavior change  Leads to higher cessation outcomes

• Patient - centered counseling style
• Collaborative
• Increases patient self-efficacy
• Avoids resistance by displaying:

 empathy  understanding  freedom of choice

 An evidence-based telephone

tobacco treatment service  Consists of four treatment sessions

• Special 10 treatment sessions

and protocol for pregnant women

 Highly trained, professional Quit

Coaches  Available free to all North Carolina residents  Accessible 24 hours a day, 7 days a week  English, Spanish and interpretation service  Integrated with an interactive web based tobacco treatment program

Spani anish sh Speakin aking 1-855 855-De Dejelo jelo-Ya Ya

Summar ary on

• n the

the Rat ation

• nal

ale e to to Regul ulat ate e Use of

• f E

E-Cigar arettes ettes

• If treated differently, implies acceptance of

addiction to nicotine delivery products, complicating a health message

• Permitting e-cigarettes encourages dual usage

(cigarettes and e-cigs) in lieu of cessation in some individuals who might otherwise quit

• Exposes children, adolescents and pregnant women

to nicotine and other toxins in e-cigarette aerosol

• Creates potential confusion regarding rules and

mixed health message

51

Jim Martin, MS Director of Policy and Programs (919)707-5404 jim.martin@dhhs.nc.gov

Questions