PRESCRIBING FOR SMOKING CESSATION (Adapted from the Self-Limiting Conditions Independent Study Program for Manitoba Pharmacists) Acknowledgements The Self-Limiting Conditions Independent Study Program for Manitoba Pharmacists was reviewed and/or developed by: Manjit Bains, Professional Development Committee, College of Pharmacists of Manitoba Drena Dunford, University of Manitoba Faculty of Pharmacy Ronda Eros, Pharmacist Consultant, College of Pharmacists of Manitoba Melissa Gobin, Pharmacy Student Apprentice, College of Pharmacists of Manitoba Ronald Guse, Registrar, College of Pharmacists of Manitoba Kyle MacNair, President, College of Pharmacists of Manitoba Kim McIntosh, Assistant Registrar, College of Pharmacists of Manitoba Kristine Petrasko, Vice President and Professional Development Committee Chair, College of Pharmacists of Manitoba Megan Scott, Professional Development Committee, College of Pharmacists of Manitoba Advit Shah, Professional Development Committee, College of Pharmacists of Manitoba Introduction Pharmacy managers should have reference material consistent with the standards of practice and any additional references that may be necessary in a pharmacy practice specific to the location and scope of practice. A member who would like to prescribe drugs for smoking cessation under Schedule 3 to the Pharmaceutical Regulation must successfully complete one of the following programs in addition to viewing the Fundamentals of Self-Limiting Conditions Prescribing for Manitoba Pharmacists presentation and have read the product monographs (and other appropriate resources) of the drugs that the pharmacist is prescribing: CATALYST (all 5 modules) PACT (Level 1 and PACT Pharmacy Specialty Module) QUIT TEACH (3 day course) Last Updated Jan 15, 2014 1
Important Notes Please read the following important notes before beginning the independent study program: Although there may be many appropriate prescription therapies for a self-limiting condition, only those included in the category for a condition listed in Schedule 3 to the Pharmaceutical Regulations can be prescribed by a pharmacist who has successfully completed the appropriate Council approved training program. (However, an extended practice pharmacist may prescribe a drug listed on Schedule 1 of the Manual for Canada's National Drug Scheduling System published by NAPRA, within the scope of his or her specialty, in accordance with applicable practice directions). A patient may be better suited to another prescription drug or therapy that cannot be prescribed by a pharmacist and should be referred to the appropriate prescriber to receive care. As well, a reminder that section 118 of the Pharmaceutical Regulations allows a member to prescribe a drug listed on Schedule 2 and Schedule 3 of the Manual for Canada's National Drug Scheduling System published by NAPRA, and a drug not listed in the Manual if it has been issued a drug identification number or a natural health product number under the Food and Drugs Act (Canada). When reviewing sources from other provinces, please note that depending on the condition, prescribing rights of pharmacists in Manitoba may differ from pharmacists in other provinces. Some drugs included under Schedule 3 to the Regulations may not have products with monographs in the CPS, whereas other drugs may have more than one applicable product monograph. It is your responsibility to use the resources available to you to ensure the medication you are prescribing is appropriate. Members must apply to the College of Pharmacists of Manitoba for the appropriate authorization to prescribe for self-limiting condition(s) once they have successfully completed the requirements. Last Updated Jan 15, 2014 2
Schedule 3 to the Pharmaceutical Regulation A member who has received authorization from the College to prescribe for self-limiting conditions (excluding smoking cessation, in addition to smoking cessation, or just smoking cessation) may prescribe a drug included in the category for the corresponding condition(s) listed in Schedule 3 to the Pharmaceutical Regulation to the 2006 Pharmaceutical Act. This schedule is included below for your convenience: For each condition, there is a list of drugs that a member can prescribe once the applicable program has been successfully completed and applicable authorization obtained from CPhM. These drugs are listed by Prescription Drug Category or anatomic therapeutic chemical (ATC) classification system. The ATC classification system is controlled by the WHO Collaborating Centre for Drug Statistics Methodology. Last Updated Jan 15, 2014 3
Combinations of drugs can only be prescribed when listed explicitly in the Prescription Drug Category. Please note that compounds can be prescribed, if and when appropriate. According to the Policy on Manufacturing and Compounding Drug Products in Canada, a compounded product must provide a customized therapeutic solution to improve patient care without duplicating an approved drug product. The rationale for the prescribing decision must always be included in the prescribing documentation. A commercially available product should always be prescribed over a compounded product if there is no additional benefit to the patient in prescribing a compounded product. For your interest, in the ATC classification system, the active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties. Drugs are classified in groups at five different levels. The drugs are divided into fourteen main groups (1st level), with pharmacological/therapeutic subgroups (2nd level). The 3rd and 4th levels are chemical/pharmacological/therapeutic subgroups and the 5th level is the chemical substance. The 2nd, 3rd and 4th levels are often used to identify pharmacological subgroups when that is considered more appropriate than therapeutic or chemical subgroups. This information and more on the WHO Collaborating Centre for Drug Statistics Methodology and ATC classification system can be found on their website: http://www.whocc.no/. Legislation and Practice Directions A review of the new Act, Regulation, including Standards of Practice, Code of Ethics and Practice Directions is required when prescribing for self-limiting conditions. The Pharmaceutical Act December 2006, defines a practice direction as follows: "practice direction" means a written statement made by the council for the purpose of giving direction to members and owners about the conduct of their practices or pharmacy operations. The applicable parts of the legislation will be reviewed in the presentation on Fundamentals of Self-Limiting Conditions Prescribing for Manitoba Pharmacists, but pharmacists wanting to prescribe for a condition listed in Schedule 3 to the Pharmaceutical Regulation must also review the following Practice Directions: Prescribing Standard of Practice #4: Prescribing and Dispensing Last Updated Jan 15, 2014 4
Standard of Practice #12: Records and Information Ensuring Patient Safety Sale of Schedule 2 Drugs Sale of Schedule 3 Drugs Please note: More Practice Directions will be included as they become available. Fundamentals of Self-Limiting Conditions Prescribing for Manitoba Pharmacists Presentation Approximate time to complete: 60 minutes Please click on the following link to view the "Fundamentals of Self-Limiting Conditions Prescribing for Manitoba Pharmacists" presentation: http://www.sbrc.tv/1/watch/308.aspx Slides for the presentation can be found at the following link: http://mpha.in1touch.org/uploaded/web/pd/self%20limiting%20conditions%20jan%209%20fi nal.pdf Prescribing for Smoking Cessation In addition viewing the Fundamentals of Self-Limiting Conditions Prescribing for Manitoba Pharmacists presentation and reading the applicable monographs, a member who would like to prescribe drugs for smoking cessation under Schedule 3 to the Pharmaceutical Regulation must successfully complete one of the following programs: CATALYST (all 5 modules) PACT (Level 1 and PACT Pharmacy Specialty Module) QUIT TEACH (3 day course) Self-assessment questions for smoking cessation are included as an optional refresher below. Answers are included on the pages following the questions. Last Updated Jan 15, 2014 5
Drugs Included Under Schedule 3 to the Regulations N07BA: Drugs used in nicotine dependence Nicotine Sublingual/buccal Nicotine Chewing gum Nicotine Inhalation Nicotine Nasal Nicotine Transdermal Varenicline* N.B. Bupropion is not included in this category SMOKING CESSATION SELF ASSESSMENT QUESTIONS: 1. Nicotine is the addicting component in cigarettes. 2. How much nicotine is delivered to the brain from one cigarette? A- 1-3mg B- 2-4mg C- 5mg D- 10mg 3. When working on smoking cessation with a client that you feel would benefit from oral nicotine replacement therapy (NRT), which would best describe the interactions that can occur between nicotine and coffee? A- Oral NRT can interact with caffeine, so best to avoid coffee or at least wait 15 minutes in between. B- It is the acidic nature of the coffee that causes a decreased absorption of the oral NRT. C- Oral NRT does not have any interactions other than varenicline. Caffeine in moderation is not a concern. D- A and B are both correct. 4. When using the nicotine inhaler for smoking cessation, how much nicotine is absorbed per cartridge? A- 10mg B- 4mg C- 2mg D- 1mg Last Updated Jan 15, 2014 6
5. If a person is contemplating quitting, this is the best time to recommend a product to help them quit! 6. There are over 400 brands of electronic cigarettes on the market. Some contain nicotine and others do not. 7. The peak effect of the nicotine mist takes approximately 60 seconds and delivers 1mg of nicotine in each spray. 8. It is NEVER recommended for a person to wear more than one nicotine patch at a time. 9. If a patient cannot tolerate varenicline at the usual dosage of 1mg BID after a reasonable trial, then it may be beneficial to start the patient at 50% of the dosage to see if the side effects are more tolerable. 10. A pharmacist in Manitoba who is authorized to prescribe for smoking cessation can legally prescribe bupropion. 11. John has quit smoking. He has been able to quit cold turkey in the past, but this time he is using NRT. What would best describe your response to him regarding his coffee intake: A. Since it is the caffeine in the coffee that interacts with nicotine, you should consider decreasing your coffee intake by about 50%. B. You should really consider cutting coffee out completely now that you have quit smoking because it is bad for your health. C. You may notice that the amount of coffee you require on a daily basis is much less than you originally required due to the interaction between the NRT and the caffeine. You may notice as you decrease the NRT, you may want to decrease your coffee intake. Last Updated Jan 15, 2014 7
D. All of the above E. None of the above 12. AC, a 56 year old male, approaches you for advice regarding smoking cessation. AC has just made the decision to quit smoking and is eager to begin the process. AC smokes about 20 cigarettes per day and has been doing so for 30 years. AC smokes his most satisfying cigarette first thing in morning usually about 45 minutes after he wakes up. He smokes most in the morning and continues to smoke in areas where it is forbidden and even when he is ill. AC has no other medical conditions and isn't on any medication. Using the modified Fagerström Nicotine Tolerance Scale, AC s level of nicotine dependence would fall into the following category: A. Low B. Moderate C. High D. Very high E. None of the above are correct After reviewing AC s past medical and medication history from the previous question and discussing alternatives with him, the decision is made to begin NRT therapy. AC has picked a quit date. He would prefer a treatment option that does not have to be taken multiple times throughout the day and is relatively discrete. Which of the following would be the most ideal initial NRT option to choose for AC? A. Nicotine 21 mg patch topically daily B. Nicotine 4 mg lozenge q1-2h prn for withdrawal symptoms (max of 15 lozenges/day) C. Nicotine 14 mg patch topically daily D. Nicotine 21mg patch topically daily and Nicotine 2mg lozenge Q1h prn E. None of the above AC returns to your pharmacy after using your selected NRT from question 3 for a few days. He is now complaining of difficulty sleeping at night and has been having disturbing dreams, which has become very troublesome. In addition, he has been having additional cravings throughout the day despite using your recommended NRT. AC discloses that he is NOT been smoking while using the NRT. He is willing to trial alternate NRT options. What advice can you provide? A. Discontinue NRT as he is not a candidate and has failed treatment. Last Updated Jan 15, 2014 8
B. Advise him to remove the nicotine patch at night for sleep and then reapply in the morning. AC can use nicotine lozenge or gum first thing in the morning along with as needed throughout the day for breakthrough cravings. The patch takes about 1 hour to hit peak effect. C. Continue with current regimen for now and offer no other suggestions, as it is too soon to make changes. D. All of the above are correct E. None of the above are correct 13. KC is a 45 year old male with a past medical history significant for hypertension, MI (one month ago), and diabetes (diet-controlled). Current list of medications include: ASA 81 mg po daily, clopidogrel 75 mg po daily, atorvastatin 80 mg po daily, metoprolol 25 mg po bid, and ramipril 5 mg po daily. KC wants to start a product to help him stop smoking. Which of the following is true for KC? A. Lozenges and/or gum may be preferred for this patient versus the nicotine patch as it is more of an acute form of nicotine (not constant) which would be a safer option for this patient. B. Evidence suggests that NRT is not safe in patients with cardiovascular disease. C. Nicotine patch may be preferred as it provides more constant nicotine plasma concentration which would be a safer option for this patient. D. All of the above are correct. E. None of the above are correct. 14. MD is a 50-year-old female who just recently quit smoking two weeks ago and is currently using NRT. She comes to your pharmacy to refill a prescription for warfarin. She discloses that her INR was last checked 1 month ago, as she has been relatively stable on her current warfarin dose. Which of the following is the BEST response: A. As NRT interacts with warfarin, it would be prudent for MD to see her physician to get a repeat INR done, as a dose adjustment may be required. B. Tobacco smoke interacts with warfarin by reducing clearance of the drug; now that MD is no longer smoking, she may require a dose increase of her warfarin dose. It would be prudent to get a repeat INR done as soon as possible. C. Tobacco smoke interacts with warfarin by increasing clearance of the drug, now that MD is no longer smoking, it would be prudent to get a repeat INR done as soon as possible and monitor closely for any signs of bleeding. D. Tobacco smoke interacts with warfarin by increasing clearance of the drug, now that MD is no longer smoking, it would be prudent to get a repeat INR done as soon as possible and monitor closely for any signs of bleeding. A dose adjustment will be required. E. None of the above are correct. Last Updated Jan 15, 2014 9
SMOKING CESSATION SELF ASSESSMENT ANSWERS: 1. Nicotine is the addicting component in cigarettes. 2. How much nicotine is delivered to the brain from one cigarette? A- 1-3mg B- 2-4mg C- 5mg D- 10mg 3. When working on smoking cessation with a client that you feel would benefit from oral nicotine replacement therapy (NRT), which would best describe the interactions that can occur between nicotine and coffee? A- Oral NRT can interact with caffeine, so best to avoid coffee or at least wait 15 minutes in between. B- It is the acidic nature of the coffee that causes a decreased absorption of the oral NRT. C- Oral NRT does not have any interactions other than varenicline. Caffeine in moderation is not a concern. D- A and B are both correct. B - Caffeine is basic, but coffee is acidic. It is the acidic component that causes the interaction, not the caffeine. 4. When using the nicotine inhaler for smoking cessation, how much nicotine is absorbed per cartridge? A- 10mg B- 4mg C- 2mg D- 1mg C - The amount delivered is 4mg, but the amount absorbed is 2mg. 5. If a person is contemplating quitting, this is the best time to recommend a product to help them quit! Last Updated Jan 15, 2014 10
False - The best time to help a person select a product is when they are READY to quit, not in the preparation stage. 6. There are over 400 brands of electronic cigarettes on the market. Some contain nicotine and others do not. True- Although electronic cigarettes with nicotine are not supposed to be on the Canadian Market, they are widely available in the USA and on the internet. 7. The peak effect of the nicotine mist takes approximately 60 seconds and delivers 1mg of nicotine in each spray. False - The peak effect of nicotine mist takes approximately 16 minutes. If the patient did not know this, he/she may have given up on the product prematurely. This would also be important for the prescriber to be aware of before switching to alternate therapies. 8. It is NEVER recommended for a person to wear more than one nicotine patch at a time. False - This may be recommended and appropriate depending on the amount of nicotine a person is consuming daily by smoking. 9. If a patient cannot tolerate varenicline at the usual dosage of 1mg BID after a reasonable trial, then it may be beneficial to start the patient at 50% of the dosage to see if the side effects are more tolerable. 10. A pharmacist in Manitoba who is authorized to prescribe for smoking cessation can legally prescribe bupropion. False- Bupropion was not included in the categories listed under Schedule 3 to the Regulations and therefore cannot be prescribed by a pharmacist at this time. Last Updated Jan 15, 2014 11
11. John has quit smoking. He has been able to quit cold turkey in the past, but this time he is using NRT. What would best describe your response to him regarding his coffee intake: F. Since it is the caffeine in the coffee that interacts with nicotine, you should consider decreasing your coffee intake by about 50%. G. You should really consider cutting coffee out completely now that you have quit smoking because it is bad for your health. H. You may notice that the amount of coffee you require on a daily basis is much less than you originally required due to the interaction between the NRT and the caffeine. You may notice as you decrease the NRT, you may want to decrease your coffee intake. I. All of the above J. None of the above E It is the acidic component of coffee that causes the interaction with NRT, not the caffeine. 12. AC, a 56 year old male, approaches you for advice regarding smoking cessation. AC has just made the decision to quit smoking and is eager to begin the process. AC smokes about 20 cigarettes per day and has been doing so for 30 years. AC smokes his most satisfying cigarette first thing in morning usually about 45 minutes after he wakes up. He smokes most in the morning and continues to smoke in areas where it is forbidden and even when he is ill. AC has no other medical conditions and isn't on any medication. Using the modified Fagerström Nicotine Tolerance Scale, AC s level of nicotine dependence would fall into the following category: F. Low G. Moderate H. High I. Very high J. None of the above are correct AC would score a 6 on the Fagerstrom Tolerance scale and a 6-7 would indicate HIGH addiction. After reviewing AC s past medical and medication history from the previous question and discussing alternatives with him, the decision is made to begin NRT therapy. AC has picked a quit date. He would prefer a treatment option that does not have to be taken Last Updated Jan 15, 2014 12
multiple times throughout the day and is relatively discrete. Which of the following would be the most ideal initial NRT option to choose for AC? F. Nicotine 21 mg patch topically daily G. Nicotine 4 mg lozenge q1-2h prn for withdrawal symptoms (max of 15 lozenges/day) H. Nicotine 14 mg patch topically daily I. Nicotine 21mg patch topically daily and Nicotine 2mg lozenge Q1h prn J. None of the above AC's preference to take or use NRT the least amount of times throughout the day which would make the patch the best option. Starting with a 21mg patch should really be enough and would not likely require gum prn since he was smoking 20 cigarettes per day. AC returns to your pharmacy after using your selected NRT from question 3 for a few days. He is now complaining of difficulty sleeping at night and has been having disturbing dreams, which has become very troublesome. In addition, he has been having additional cravings throughout the day despite using your recommended NRT. AC discloses that he is NOT been smoking while using the NRT. He is willing to trial alternate NRT options. What advice can you provide? F. Discontinue NRT as he is not a candidate and has failed treatment. G. Advise him to remove the nicotine patch at night for sleep and then reapply in the morning. AC can use nicotine lozenge or gum first thing in the morning along with as needed throughout the day for breakthrough cravings. The patch takes about 1 hour to hit peak effect. H. Continue with current regimen for now and offer no other suggestions, as it is too soon to make changes. I. All of the above are correct J. None of the above are correct Ideally we would want to allow our client to remove the patch at night to avoid these symptoms, however, B is incorrect based on the time to reach peak effect (would take 2-6 hours). 13. KC is a 45 year old male with a past medical history significant for hypertension, MI (one month ago), and diabetes (diet-controlled). Current list of medications include: ASA 81 mg po daily, clopidogrel 75 mg po daily, atorvastatin 80 mg po daily, metoprolol 25 mg po bid, and ramipril 5 mg po daily. KC wants to start a product to help him stop smoking. Which of the following is true for KC? Last Updated Jan 15, 2014 13
F. Lozenges and/or gum may be preferred for this patient versus the nicotine patch as it is more of an acute form of nicotine (not constant) which would be a safer option for this patient. G. Evidence suggests that NRT is not safe in patients with cardiovascular disease. H. Nicotine patch may be preferred as it provides more constant nicotine plasma concentration which would be a safer option for this patient. I. All of the above are correct. J. None of the above are correct. Acute forms of NRT tend to cause more of the spikes in the blood levels of nicotine which can be harder on the heart. It would be preferred to have the constant levels of the patch for these patients. 14. MD is a 50-year-old female who just recently quit smoking two weeks ago and is currently using NRT. She comes to your pharmacy to refill a prescription for warfarin. She discloses that her INR was last checked 1 month ago, as she has been relatively stable on her current warfarin dose. Which of the following is the BEST response: F. As NRT interacts with warfarin, it would be prudent for MD to see her physician to get a repeat INR done, as a dose adjustment may be required. G. Tobacco smoke interacts with warfarin by reducing clearance of the drug; now that MD is no longer smoking, she may require a dose increase of her warfarin dose. It would be prudent to get a repeat INR done as soon as possible. H. Tobacco smoke interacts with warfarin by increasing clearance of the drug, now that MD is no longer smoking, it would be prudent to get a repeat INR done as soon as possible and monitor closely for any signs of bleeding. I. Tobacco smoke interacts with warfarin by increasing clearance of the drug, now that MD is no longer smoking, it would be prudent to get a repeat INR done as soon as possible and monitor closely for any signs of bleeding. A dose adjustment will be required. J. None of the above are correct. Because the pharmacokinetic drug interaction seems to be considered not clinically significant we won t likely require a change in dose unless the INR is affected or increased bleeding occurs. A dose change will not be required in all cases. Last Updated Jan 15, 2014 14