Tobacco  Cessation  Products  Review  

Amy  Bachyrycz,  Pharm.D.  Shared  Faculty,  UNM  COP  

Walgreens  Pa?ent  Care  Center    

Objectives  

• Tobacco  cessa?on  product  review  • Current  clinical  evidence  regarding  tobacco  cessa?on  

• Case  based  applica?on  of  tobacco  cessa?on  products  

• Pharmacist  role  and  perspec?ve  in  tobacco  cessa?on  efforts  

Pathophysiology  of  Smoking  •  Repeated  exposure  develops  neuroadapta?on  of  the  receptors  

•  Develops  tolerance  to  it’s  own  ac?on  with  repeated  use  •  Pharmacotherapies  reduce  withdrawal  symptoms  and  block  the  reinforcing  effects  of  nico?ne  •  Without  causing  excessive  adverse  effects  

•  All  FDA  approved  tobacco  cessa?on  products  are  safe  for  short  and  long  term  use  

•  Combina?on  therapy  may  be  indicated  for  pa?ents  that  may  have  failed  monotherapy  or  with  heavy  chemical  addic?on  

Jiloha R. Pharmacotherapy of Smoking Cessation. Indian J of Psych. 2014.

Why  Do  We  Smoke?  •  Rewards  •  Boredom  •  Habit  •  Addic?on  

Neurobiology  of  Smoking  •  Tip  of  a  lighted  cigareNe,  burns  at  800  degrees  Celsius  •  With  each  puff,  draws  into  one’s  mouth  gases  and  many  sized  par?cles  

•  Of  the  4000  chemicals  iden?fied  in  tobacco  smoke,  nico?ne  is  responsible  for  a  number  of  pathophysiological  changes  in  the  body  

•  Nico?ne  remains  dissolved  in  the  moisture  of  the  tobacco  leaf  as  a  water  soluble  salt,  in  a  burning  cigareNe  it  vola?lizes  &    remains  suspended  on  minute  droplets  of  tar  as  free  nico?ne  •  Droplets  reach  smallest  alveoli  of  the  lungs  

•  About  90%  of  the  nico?ne  present  in  inhaled  smoke  is  absorbed  (11-­‐15  seconds)  

•  Yields  increase  in  dopaminergic  ac?vity  and  euphoria/pleasure  

FDA  Approved  Products  

• NRT  (also  over-­‐the-­‐counter)    • Patch,  gum,  lozenge  

• NRT  (prescrip?on  only)  • Inhaler,  nasal  spray  

• Varenicline  • Zyban  and  generic    

Plasma Nicotine Concentrations

0

5

10

15

20

25

1/0/1900 1/10/1900 1/20/1900 1/30/1900 2/9/1900 2/19/1900 2/29/1900

Plas

ma

nico

tine

(mcg

/l)

Cigarette

Moist snuff

Nasal spray

Inhaler

Lozenge (2mg)

Gum (2mg)

Patch

0 10 20 30 40 50 60

Time (minutes)

Cigarette

Moist snuff

Review  of  5A’S  •  5A’s  are  part  of  NM  Board  of  Pharmacy  protocol  •  5A’s  will  gather  all  necessary  info  for  workup/SOAP  note  •  5A’s  will  determine  what  behavioral  modifica?on  you  recommend  for  your  pa?ent  

•  5A’s  will  determine  and  jus?fy  what  product  you  chose  to  prescribe  •  Ask  every  pa+ent  about  tobacco  use  •  Advise  all  smokers  to  quit  •  Assess  smokers'  willingness  to  quit  •  Assist  smokers  with  treatment  and  referrals  •  Arrange  follow-­‐up  

Fagerstrom  •  Smoking  is  a  2  part  addic?on  • Determines  level  of  addic?on  

•  How  soon  aber  waking  do  you  smoke  your  first  cigareNe?  •  Time  less  than  5  minutes:  3  points    •  Time  5  to  30  minutes:  2  points    •  Time  31  to  60  minutes:  1  point    

•  Interpreta?on    •  Heavy  nico?ne  dependence:  5-­‐6  points  • Moderate  nico?ne  dependence:  3-­‐4  points  •  Light  nico?ne  dependence:  0-­‐2  points    

Steps  to  Case  Work-­‐up  •  Iden?fy  pa?ent  is  in  Stage  2  model  for  change  •  Sign  consent  form  •  Complete  5A’s  •  Complete  Fagerstrom  (op?onal)  •  Agree  on  behavioral  modifica?ons  to  make  •  Agree  on  TC  product,  dose,  side  effects,  contraindica?ons  •  Write  brief  work-­‐up/SOAP  to  store  in  pharmacy  using  5A’s  •  Write  script,  fill  and  dispense  (charge  pt  for  med/counseling)  •  No?fy  PCP/healthcare  team,  w/  pa?ent  consent,  within  15  dys  

SOAP      •  Subjec?ve  

•  HPI  (chief  complaint,  stage  in  quiing  process)  •  SH  (age,  gender,  occupa?on,  etoh,  cpd)  •  PMH  Medica?ons  (prescrip?on,  OTC,  discon?nued  meds)  

•  Objec?ve  •  Vitals  •  Lab  Values  

•  Assessment  •  Triggers  and  associa?ons,  readiness  to  quit,  product  jus?fica?on  

•  Plan  •  Quit  date,  1800  Quit  Now  reference  if  appropriate  •  Specific  pharmacotherapy  and  behavioral  modifica?ons  •  PCP/healthcare  team  no?fied  and  date  documented  

Case  1  • 65  y/o  re?red  pt  John  Smith,  DOB  10/22/48  • Appears  depressed,  no  work-­‐up  or  diagnosis  • Smokes  1  ppd  x  15  yrs  • PMH:  open  heart  surgery  several  years  back  • Meds:  metoprolol  • References  a  posi?ve  experience    with  Commit  

• Ready  to  quit  in  the  next  30  days  

Case  1  Possible  Regimens  •  CBT  (lifestyle  modifica?ons)  

•  Smokers  do  not  plan  to  fail  they  fail  to  plan  •  Slip  vs  relapse  plan  of  ac?on  

•  Smoke    break  plan  of  ac?on  •  Crisis  plan  of  ac?on  •  Avoid  triggers  and  associa?ons  

•  NRT  (single  or  in  combo)  •  Avoid  in  MI,  arrhythmia,  angina  •  Once  on,  smoking  must  cease  •  Gum  or  bupropion:  evidence  of  appe?te  suppression  •  Nasal  spray:  avoid  in  asthma,  COPD,  URI  

Case  1  Possible  Regimens  •  Bupropion  (with  or  without  NRT)  

•  Taper  (150mg  daily  x  3-­‐7  dys,  then  bid  thereaber)  •  Does  not  require  taper  to  DC  •  Avoid  in  ea?ng  d/o,  seizures,  alcoholism,  meds  that  lower  seizure  threshold,  liver  failure  or  elevated  lipid  panel,  currently  on  Wellbutrin  

•  Varenicline  (USE  ALONE)  •  Avoid  in  underlying  anxiety/depression  •  Discuss  side  effects  clearly  

•  Nausea,  dreams,  neuropsych  symptoms  •  Banned  in  commercial  drivers,  pilots,  air  traffic  contr.  •  Careful  in  renal  failure  &  underweight  individuals  

Varenicline  and  combination  NRT,  found  most  effective  •  Evidence  Based  Medicine  Journal  reported  findings  from  12  treatment  specific  reviews  of  high  methodological  quality:  •  Varenicline  was  superior  to  NRT  monotherapy  •  Varenicline  was  superior  to  bupropion  •  Varenicline  was  not  superior  to  combina?on  NRT  •  NRT  and  bupropion  were  of  equal  efficacy  

•  The  reviews  did  not  find  an  increase  of  neuropsychiatric  events  with  either  varenicline  or  bupropion  compared  to  placebo  

•  The  reviews  had  compelling  evidence  that  varenicline,  aber  proper  screening,  does  not  cause  an  increase  in  serious  adverse  effects  

Ebbert J. Varenicline and combination nicotine replacement therapy are the most effective pharmacotherapies for treating tobacco use. Evid Based Med. 2013.

Nicotine  Gum  Suggested  Dosing  

Recommended Usage Schedule for Nicotine Gum

Weeks 1–6 Weeks 7–9 Weeks 10–12

1 piece q 1–2 h 1 piece q 2–4 h 1 piece q 4–8 h

DO NOT USE MORE THAN 24 PIECES PER DAY.

If patient smokes Recommended strength

≥25 cigarettes/day 4 mg

<25 cigarettes/day 2 mg

Nicotine  Lozenge  Dosing  Dosage is based on the “time to first cigarette” (TTFC) as an indicator of nicotine addiction

Use Commit Lozenge 2 mg: If you smoke your first cigarette more than 30 minutes after waking up

Use Commit Lozenge 4 mg: If you smoke your first cigarette of the day within 30 minutes of waking up

Nicotine Lozenge Suggested Dosing

Recommended Usage Schedule for Commit Lozenge

Weeks 1–6 Weeks 7–9 Weeks 10–12

1 lozenge q 1–2 h

1 lozenge q 2–4 h

1 lozenge q 4–8 h

DO NOT USE MORE THAN 20 LOZENGES PER DAY.

Nicotine Patch Suggested Dosing

Product Light Smoker Heavy Smoker

Nicoderm CQ ≤10 cigarettes/day Step 2 (14 mg x 6 weeks)

Step 3 (7 mg x 2 weeks)

>10 cigarettes/day Step 1 (21 mg x 6 weeks)

Step 2 (14 mg x 2 weeks)

Step 3 (7 mg x 2 weeks)

Generic

≤10 cigarettes/day Step 2 (14 mg x 6 weeks)

Step 3 (7 mg x 2 weeks)

>10 cigarettes/day Step 1 (21 mg x 4 weeks)

Step 2 (14 mg x 2 weeks)

Step 3 (7 mg x 2 weeks)

Nicotine  Nasal  Spray  •  Aqueous  solu?on  in  a  10-­‐ml  spray  boNle  

•  Start  with  1–2  doses  per  hour  •  Increase  prn  to  max.  dosage  of  5  doses  per  hour  

•  For  best  results,  use  at  least  8  doses  daily  for  the  first  6–8  weeks  

•  Gradual  tapering  over  an  addi?onal  4–6  weeks  needed  

Nicotine  Inhaler  n  Start with 6 cartridges/day (4mg/cartridge delivered)

n  Increase prn to maximum of 16 cartridges/day

n  Use for minimum of 3 weeks, maximum of 12 weeks

n  Gradual dosage reduction over additional 6–12 weeks

Varenicline  Dosing  Instructions  •  Starter  Pack  

•  Take  0.5mg  daily  on  days  1  through  3  •  Take  0.5mg  bid  on  days  4  through  7  •  Take  1mg  bid  thereaber  

•  Con?nuing  Pack  •  Take  1mg  bid  

•  Counseling  Points  •  Take  with  food  •  Take  at  least  8  hrs  apart,  but  not  aber  6pm  •  If  side  effects  occur,  immediately  discon?nue  

Product  Success  Rates  •  JAMA,  January  2014  compiled  results  from  267  studies  

•  NRT,  17.6%  success  rate  •  Bupropion,  19.1%  success  rate  •  Placebo,  10.6%  success  rate  •  Varenicline,  27.6%  success  rate  •  Combina?on,  NRT  31.5%  success  rate  (patch  plus  inhaler)  

 

Cahill K, et al. Pharmacological treatments for tobacco cessation. Jama. 2014.

Case  2  •  Female  Jonah  Smith  DOB  3/15/1980,  owns  a  restaurant  •  No  PMH  and  no  medica?ons  •  Smokes  15  cpd,  mostly  while  at  work  •  Interested  in  quiing  to  encourage  staff  to  quit  •  Failed  NRT  (patch)  in  past  due  to  numbness  in  the  arm  

Case  2  Possible  Regimens  • CBT  (lifestyle  modifica?ons)  • NRT  (single  or  in  combo)  

• Wants  to  quit  today  • Bupropion  (with  or  without  NRT)  • Varenicline  (ALONE)  

Varenicline  with  NRT  •  South  Africa,  JAMA  2014  (24  week  trial,  n=446))  •  Iden?fied  that  it  is  unclear  if  varenicline  plus  NRT  is  effec?ve  and  safe    •  Nico?ne  patch  plus  varenicline  vs.  varenicline  alone  

•  Combina+on  therapy  was  associated  with  higher  abs+nence  rates  at  week  12  (55.4%  vs.  40.9%)  and  week  24  (49.0%  vs.  32.6%)  

•  Combina?on  therapy  was  associated  with  adverse  events  •  Nausea,  sleep  disturbance,  skin  reac?ons,  cons?pa?on,  depression,  

•  Only  skin  reac?on  reached  sta?s?cal  significance  (P=0.03)    

Coenraad  F,  et  al.  Efficacy  of  varenicline  combined  with  NRT  vs.  varenicline  alone  for  smoking  cessa?on.  JAMA.  2014.    

Case  3  •  You  have  an  appt.  with  Mr.  Bradshaw,  a  46  y/o  man  who  is  50lbs  overweight  

• He  is  agitated  because  he  had  to  wait  while  you  finished  up  with  a  pa?ent  

• He  reports  NKDA,  however,  he  has  HTN  and  hyperlipidemia  

•  You  no?ce  a  box  of  Marlboro  lights  in  his  leb  chest  pocket,  but  he  is  NOT  ready  to  quit  

 

Case  3  Possible  Suggestions  •  5  R’s  

• Not  ready  to  quit  • Mo?va?onal  counseling  

•  Plan  or  Assist  &  Arrange  •  1-­‐800-­‐QuitNow  card  

•  Free  gum/patches  if  no  current  condi?on  •  Possible  phone  call  in  30  days  

Smokeless  Tobacco  •  Clinical  evidence  is  limited  •  All  tobacco  cessa?on  products  may  be  used  

Varenicline  in  Smokeless  Tobacco  •  Systema?c  review,  meta-­‐analysis  •  Evaluated  3  published  randomized  clinical  trials  involving  744  users  comparing  varenicline  vs.    placebo  

•  Abs?nence  at  12  weeks  (48.0%  vs.  33.0%)  •  Abs?nence  at  26  weeks  (49.0%  vs.  39.0%)  •  Overall,  no  sta?s?cally  significant  differences  in  the  incidence  of  adverse  events  

Schwartz J, et al. Use of varenicline in smokeless tobacco cessation. Nicotine & Tobacco Research. 2015.

Pharmacists  Prescriptive  Authority  Protocol  Highlights  • Counseling  x  90  minutes/pa?ent  • Must  get  some  work-­‐up  of  pa?ent  (PMH,  SH)  • Approved  training  (RX  F  C  curriculum)  •  2  Live  CE’s  Q  2  yrs  • Prescribe  FDA  approved  medica?ons  •  Informed  Consent  w/  approval  to  no?fy  PCP  in  15  dys  of  Rx  if  iden?fied  

• Pt  F/u  •  *  Group  sessions  are  allowed  

Patient  Info.  For  Group  Session    § Benefits  to  quiing  

§  Cough  may  resolve    §  Exercise  tolerance  improves  rapidly  §  Bladder  cancer:  50%  reduc?on  in  5  years  §  Lung  cancer:  50%  reduc?on  in  10  years  §  Heart  disease:  50%  reduc?on  in  1  year  §  Vascular  disease:  50%  reduc?on  in  5  years  §  Mortality:  improves  lifespan  by  appx.  10-­‐15  yrs  

Pharmacists  Must  Refer…  •  For  bupropion  prescribing  only  

•  Seizure  disorder/Ea?ng  disorder  •  Alcoholism  •  Liver  cirrhosis  

•  Contraindica?on  to  specific  therapy  •  NRT  

•  Arrhythmias  •  MI  (h/o)  •  Angina,  worsening  

•  Varenicline  •  Depression/anxiety  

•  Risks  are  greater  than  benefits  

Barriers  to  Increased  Pharmacist  Intervention  •  Federal  provider  status  •  Lack  of  third  party  payer  coverage  for  products  •  Lack  of  federal  funds  (excludes  pregnant  pa?ents)  •  Lack  of  corporate  support  •  Workload  difficult  to  manage  •  F/u  difficult  (e.g.  phone  numbers  disconnected,  no-­‐shows)  

Summary  •  Tobacco  cessa?on  product  review  includes  products  that  may  be  more  suitable  for  individual  pa?ents  

•  Clinical  evidence  is  limited  (e.g.  e-­‐cigareNes,  smokeless  tobacco)  and  tobacco  cessa?on  efforts  

•  All  healthcare  professionals  have  a  role  in  tobacco  cessa?on  advoca?ng  

•  Pharmacist  prescrip?ve  authority  exists,  but  barriers  exist  in  NM