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Challenges to Effective Medication Use

Challenges to Effective Medication Use. February 19, 2003 Richard D. Hurt, M.D. Professor of Medicine Director, Nicotine Dependence Center Mayo Clinic www.mayoclinic.org/ndc-rst. 46 y/o Neurosurgeon. Began smoking age 11, currently smokes 20-30 cpd

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Challenges to Effective Medication Use

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  1. Challenges to Effective Medication Use February 19, 2003 Richard D. Hurt, M.D.Professor of MedicineDirector, Nicotine Dependence CenterMayo Clinic www.mayoclinic.org/ndc-rst

  2. 46 y/o Neurosurgeon • Began smoking age 11, currently smokes 20-30 cpd • Multiple prior attempts to stop: cold turkey, acupuncture, nicotine patch, hypnosis, bupropion, and aversion therapy • Withdrawal symptoms: anxiety, impatient, craving,  appetite, and irritability • Longest previous smoking abstinence: 2-3 days • Persistent and chronic cough

  3. 46 y/o Neurosurgeon (cont.) • Admitted for residential treatment, CO=25 ppm • Bupropion 150 bid begun before admission • Nicotine patch dose 35 mg/d • Severe cravings and loss of concentrating ability • Baseline cotinine 621 mg/mL

  4. 46 y/o Neurosurgeon (cont.) • Day 3: Nicotine patch dose  to 42 mg/d but still had constant low grade urge to smoke. Add nicotine gum. • Day 5: Struggling with withdrawal symptoms and emotional lability.  patch dose to 63 mg/d. Steady state cotinine 259 mg/mL.

  5. 46 y/o Neurosurgeon (cont.) • Day 6: Improved. Less emotional lability. Appears more relaxed. Still has urges. Doesn’t recall very much of the first 3 days after admission. She critiqued a video on day 2 but had no recall of that.  nicotine patch dose to 77 mg/d. • Days 7-8: Comfortable on 77 mg nicotine patch dose + bupropion + 6-10 pieces of nicotine gum/d.

  6. 46 y/o Neurosurgeon (cont.) • Week 2: Patch dose reduced to 70 mg/d (2 - 21 and 2 - 14 mg patches) + bupropion + nicotine gum. Some emotional lability. • Week 8: Symptoms of depression – insomnia, loss of appetite and some suicidal ideation. She had ’d her dose of bupropion to 200 mg/d at week 4. Also had ‘d nicotine patch dose to 35 mg/d + 6 pieces of nicotine gum/d. Returned to work half-time.

  7. 46 y/o Neurosurgeon (cont.) • Week 13: Her internist had ’d her bupropion dose to 450 mg/d and added mitrazapine 60 mg/d. Off nicotine patch therapy. 6 pieces nicotine gum/d. • Week 16: Saw psychiatrist in Rochester. Major depression in partial remission. Obsessive-compulsive personality traits. • Weeks 28-40: Begin reducing mitrazapine. Continue bupropion 450 mg/d but begin reducing week 32. Nicotine gum 4-6/d. Therapy visit with psychiatrist every 2 months.

  8. 46 y/o Neurosurgeon (cont.) • Week 48: Had reduced bupropion to 150 mg/d and mitrazapine to 15 mg/d.  dysphoria and  insomnia –  bupropion to 150 mg/d. “Still vulnerable to reemergence of significant depression.” • Week 52: Bupropion 150 mg BID. Nicotine gum 1-3/d. Therapy visit with psychiatrist. • Week 64: Final therapy session with psychiatrist. Bupropion 150 mg/d. Mitrazapine 15mg HS. Nicotine gum 6/d. Dismissed back to her internist.

  9. 53 y/o WM Executive • Smoked cigarettes as early as age 5 • 20 cpd until 1991 MI  CABG x 3 • 3 mos post-MI – relapse to smoking cigarettes • Switched to pipe – “I knew I couldn’t smoke cigarettes anymore • Inhaled the pipe smoke from outset • 3-5 bowls of pipe tobacco per day

  10. 53 y/o WM Executive (cont.) • Multiple attempts to stop “cold turkey” never more than a day • Abstinence with nicotine patch + bupropion but serious w/d symptoms – decreased mood, inability to concentrate, anxiety, and craving • Relapsed during high stress at work • Admitted for residential treatment – Rx bupropion + 21 mg nicotine patch

  11. 53 y/o WM Executive (cont.) • Persistent “anxiety” symptoms   patch dose to 2 - 21 mg patches • PFT – COPD • Baseline cotinine 516 ng/ml, steady state 265 ng/ml •  patch dose to 3 - 21 mg patches + NNS  less anxiety symptoms • Dismissed on 3 - 21 mg nicotine patch dose + bupropion + ad lib nicotine gum and NNS for crises

  12. Hurt RD, et al. Clin Pharmacol Ther 54:98-106, 1993

  13. Lawson GM, et al. J Clin Pharmacol 38:502-509, 1998

  14. High Dose Patch TherapyConclusions • High dose patch therapy safe for heavy smokers • Smoking rate or blood cotinine to estimate initial patch dose • Assess adequacy of nicotine replacement by patient response or percent replacement • More complete nicotine replacement improves withdrawal symptom relief • Higher percent replacement may increase efficacy of nicotine patch therapy

  15. Therapeutic Drug Monitoring • Clinicians recognize limitations of empirical dosing (standard or fixed dose regimens) • Clinical observations have led to individualizing patient drug doses • Allows scientific approach to selecting drug regimen to achieve targeted serum concentration • Serum drug analyses are critical adjunct to optimal therapeutic drug utilization

  16. Pharmacotherapy for Tobacco DependenceMultifactoral Problem • Relatively few medications • Virtually no changes in existing medications since introduction • ONE new medication (nicotine lozenge) introduced in past 5 years • Multiple barriers to use – clinicians, patients, payers, tobacco industry

  17. Pharmacotherapy for Tobacco DependenceClinicians • Lack of familiarity with and understanding of existing medications • Concern about safety – overdosing and abuse liability • Perceived low efficacy

  18. Pharmacotherapy for Tobacco DependencePatients • Low self-esteem and embarrassment • Expense • Inadequate relief of withdrawal and craving • Concern about safety – underdosing and short duration of use • Hard to use products – gum, inhaler, nasal spray • Pharmaceutical marketing focus on competition rather than the problem

  19. Pharmacotherapy for Tobacco DependencePayers • Perceived low efficacy • Concern about costs – fear of “herd” effect • Perception it is the patient’s responsibility – choice and self-quitting • Not buying cigarettes should offset cost to patient

  20. Pharmacotherapy for Tobacco DependenceTobacco Industry • Highly sophisticated products and marketing • Underregulated and politically protected • Enormous resources and pervasive influence • Constantly preempting or adapting to public health environment • Morally and ethically bankrupt

  21. Pharmacotherapy for Tobacco DependenceNicotine Withdrawal Syndrome • Needs to be revisited with more scientific vigor • Spectrum of symptoms is broader than presently defined • Better understanding of neurophysiology of withdrawal and craving • Pharmacotherapy targeted toward withdrawal and/or craving

  22. Pharmacotherapy for Tobacco DependenceIdeal Drug • High efficacy – withdrawal and craving relief, tobacco abstinence plus relapse prevention • Few side effects • Easy to administer • Long duration of action • Positive ancillary effects – no weight gain or weight loss, improved mood, eliminates wrinkles……

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