Implementing the Tobacco Control Act: Advice to the FDA Smoking Cessation

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Implementing the Tobacco Control Act Advice to
the FDASmoking Cessation

• Lisa Kroon, PharmD
• Professor of Clinical Pharmacy
• Department of Clinical Pharmacy
• UCSF School of Pharmacy
• kroonl_at_pharmacy.ucsf.edu
• August 28, 2009

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Recommendations for FDA

• Center for Tobacco Products website
  http//www.fda.gov/TobaccoProducts/default.htm
• To contain the most up-to-date information
• Current information can be confusing to HCPs and
  consumers
• Products not necessarily available in stores
  (e.g., Habitrol patch)
• Products not necessarily available in the U.S.
• Thrive nicotine gum (Novartis) not available
• Caution consumers about products available via
  internet Amazon sells Nicotrol gum which is not
  available in stores in the U.S.
• Information to be formatted in a consumer
  friendly format
• For example, the Smoking Cessation Products to
  Help You Quit

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PHARMACOTHERAPY
Clinicians should encourage all patients
attempting to quit to use effective medications
for tobacco dependence treatment, except where
contraindicated or for specific populations for
which there is insufficient evidence of
effectiveness.
Includes pregnant women, smokeless tobacco
users, light smokers, and adolescents.
Medications significantly improve success rates.
Fiore et al. (2008). Treating Tobacco Use and
Dependence 2008 Update. Clinical Practice
Guideline. Rockville, MD USDHHS, PHS, May 2008.
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FDA APPROVALS SMOKING CESSATION
2002
Rx transdermal nicotine patch
1997
1996
OTC nicotine lozenge
1991
Rx nicotine gum
Rx nicotine inhaler Rx bupropion SR
OTC nicotine gum patchRx nicotine nasal spray
1984
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Recommendations for FDA, cont

• Switch remaining Rx NRT to OTC
• Nasal spray
• Oral inhaler
• Caution insurance coverage not affected
• Urge insurers to cover all 1st line smoking
  cessation medications, including combination
  therapy
• Recommend Medicare to cover smoking cessation
  medications
• As is, OTC medications not included in Part D
• View as cancer prevention

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Recommendations for FDA, cont

• Provide option for smaller sized (e.g., daily)
  OTC packaging
• Current packaging can be prohibitive for patients
  due to larger out-of-pocket expense at point of
  sale
• 40-50 for 14 patches
• 33 for 40 pieces of gum (generic)
• 40-45 for 100 pieces of gum (generic)
• 43-70 for 170 pieces of gum

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Recommendations for FDA, cont

• Update OTC NRT labeling to reflect current
  evidence and Clinical Practice Guideline
  (p118-122) for combination therapy
• Gum Warnings
• Do not use if you continue to smoke, chew
  tobacco, use snuff, or use a nicotine patch or
  other nicotine containing products.  
• Ask a doctor or pharmacist before use if you are
  using a non-nicotine stop smoking drug, taking
  prescription medicine for depression or asthma. 
  Your prescription dose may need to be adjusted.
• Lozenge Warnings
• Ask a doctor or pharmacist before use if you are
  using a non-nicotine stop smoking drug
• Patch Warnings
• Do not use  If you continue to smoke, chew
  tobacco, use a nicotine gum or other nicotine
  containing products
• Ask a doctor or pharmacist before use if you are
  using a non-nicotine stop smoking drug

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Recommendations for FDA, cont

• FDA to vigorously regulate smoking substitutes
• E-cigarettes http//www.fda.gov/newsevents/public
  healthfocus/ucm172906.htm
• Prohibit the sale of tobacco products in
  establishments where health care is rendered
• For example, pharmacies
• Many pharmacies now even contain clinics within
  the store
• It is a contradiction to provide health care and
  simultaneously sell products that kill 50 of
  its users

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