TOBACCO AND NICOTINE CESSATION AND CONTROL

To support pharmacists’ practice in providing nicotine‑cessation counseling and comprehensive medication management, including the appropriate use of FDA-approved nicotine‑replacement therapy, and to promote pharmacist prescriptive authority; further,

To discourage the use and oppose the distribution and sale of tobacco, tobacco products, and non-tobacco nicotine (NTN) delivery systems not approved as cessation therapies; further,

To support efforts to expand patient access to tobacco cessation medications, including availability of affordable tobacco cessation medication (including zero-cost options); further,

To advocate for healthcare environments to be free of tobacco and NTN. 

Rationale

Pharmacists, as healthcare providers, have long discouraged the use of tobacco and tobacco products as a threat to public health. Non-tobacco nicotine (NTN) is available in numerous forms, including electronic nicotine delivery systems (e.g. vaporizers, vape pens, hookah pens, and electronic cigarettes and pipes), and more recently, nicotine pouches. Contents of these highly addictive systems include nicotine, flavorings, propylene glycol, glycerin, potentially harmful aerosols, and other unknown ingredients. The long-term effects of use are still relatively unknown, and given these uncertainties, pharmacists should discourage their use. ASHP opposes the distribution or sale of tobacco, tobacco products, and other nicotine delivery systems by pharmacies or facilities that contain a pharmacy (e.g., grocery or retail stores) and advocates that hospitals and health systems be tobacco-free environments.

Through Section 907 of the Federal Food, Drug and Cosmetic Act, the Food and Drug Administration (FDA) has the authority to propose and adopt tobacco product standards including maximum N-Nitrosonornicotine (NNN) in smokeless tobacco products, nicotine yield in cigarettes, and other regulation for combusted tobacco products. The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) prohibits cigarettes or any of their component parts (including the tobacco, filter, or paper) shall not contain artificial or natural flavor (other than tobacco or menthol) or an herb or spice.  Flavor, an often characterizing element of tobacco products, has significantly influenced nicotine use in children and adolescents. In response to the increase in NTN products, Congress passed H.R.2471 which expanded FDA’s authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine.

Pharmacists have a role in recommending and managing drug therapy to support cessation of nicotine-containing products, including tobacco and electronic nicotine delivery systems, as described in the ASHP Therapeutic Position Statement on Cessation of Tobacco Use. Newer therapies, including varenicline, are associated with more and evolving safety risks when compared to nicotine replacement therapies. Given the complexity of drug therapy, pharmacists should play a central role in ensuring the safe and appropriate use of these therapies including patient assessment, education, prescribing, and monitoring of pharmacologic therapies. Given the public health impact of smoking, several states already have programs that provide, cover, or facilitate access to nicotine cessation programs that primarily operate through State Departments of Health (or Public Health), Medicaid Agencies, and State Quitlines, with some providing tobacco cessation medications for qualifying patients and/or have collaborative practice agreements that permit pharmacists to prescribe tobacco cessation medications.