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DRAFT --------- NAVMEDCENPTSVAINST 6200.5A NAVMEDCENPTSVA INSTRUCTION 6200.5A Subj: TOBACCO CESSATION PROGRAM POLICY Ref: (a) OPNAVINST 6100.2, Health Promotion Program (b) NAVMEDCENPTSVAINST 6280.1 E, Smoking and Tobacco Use Policy (c) Firoe MC, Bailey WC, Cohen SJ, et al: Treating Tobacco Use and Dependence. Clinical Practice Guideline, Rockville, MD: U.S. Dept. of Health and Human Services. Public Health Service. June 2000. (d) Office of Surgeon General, Tobacco Cessation Guidelines, Treating Tobacco Use and Dependence, www.surgeongeneral.gov/tobacco (e) American Cancer Society, Tobacco And Cancer, www.cancer.org (f) American Psychiatric Association: Practice Guidelines for the Treatment of Patients with Nicotine Dependence, American Journal Psychiatry 1996; 153:1-31. (g) American Lung Association: Not On Tobacco (NOT) Program, www.lungusa.org (h) Center for Disease Control: Tobacco Information and Prevention Source, www.cdc.gov/tobacco (i) Health Promotion, Navy Environmental Health Center (NEHC): Tobacco Cessation, wwwnehc.med.navy.mil/hp/tobacco/index.htm (j) DoD Survey of Health Related Behaviors, 1998 (k) Navy Tobacco Metrics, www- nehc.med.navy.mil/ downloads/hp/TobaccoMetrics Encl: (1) Standard Form 600 Overprint, Tobacco Cessation Program Overprint, Zyban/Nicotine Replacement Therapy Screening Form (2) NMCP Tobacco Cessation Prescription Policy (3) Provider Guidelines for Prescribing Tobacco Cessation Medications NAVMEDCENPTSVA INSTRUCTION 6200.5A 1. Purpose: To provide an ongoing Tobacco Cessation Program that will: (a) Promote operational readiness and a healthier lifestyle by providing active duty military personnel the opportunity, information and support to become tobacco free. (b) Promote a healthier lifestyle for eligible beneficiaries by providing the opportunity, information and support to become tobacco free. (c) Provide medication support, as applicable, for participants who are authorized to receive medication from military treatment facilities. 2. Cancellation: NAVMEDCENPTSVA INSTRUCTION 6200.5 3. Scope. This instruction applies to the core hospital and Branch Medical Clinics, which comprise the Naval Medical Center (NAVMEDCEN), Portsmouth command and regional commands as applicable. 4.Background: As stated in reference (d), tobacco use is the single greatest cause of disease and preventable death in America today, and is responsible for more than 430,000 deaths each year. The following six systems strategies are recommended by U.S. Public Health Services as part of a coordinated effort to provide consistent and effective tobacco interventions: (a) Implement a Tobacco-user Identification System in every clinic (b) Provide education, resources and feedback to promote provider information (c) Dedicate staff to provide tobacco dependence treatment and assess the delivery of this treatment in staff performance evaluations (d) Promote hospital policies that support and provide tobacco dependence services (e) Include tobacco dependence treatments (both counseling and pharmacotherapy) as paid or covered services for all subscribers or members of health insurance packages (f) Reimburse clinicians and specialists for delivery of effective Tobacco Dependence treatments and include them among the defined duties of clinicians. 2 NAVMEDCENPTSVA INSTRUCTION 6200.5A 5.Goals: a. Support Force Health Protection and promote operational readiness by reducing the number of tobacco users in the military. b. Promote and provide Tobacco Cessation Programs, educational resources, counseling, support and relapse management to eligible beneficiaries in a manner that considers cultural language and educational diversity. c. Educate and train designated personnel to become Tobacco Cessation Facilitators and offer tobacco cessation classes for military and eligible beneficiaries. d. Collect Tobacco Cessation Program Metrics and identify methods of improving the program 6.Procedures: a. Wellness Department Head (WDH) (1) Directs the development and implementation of the Tobacco Cessation Program according to reference (a) through (k) (2) Collaborates with the Preventive Care and Wellness Service Line Leader, NEHC Tobacco Cessation Program Director, and other agencies involved with Tobacco Cessation, to enhance the program and improve outcomes for the region. (3) Directs ongoing Performance Improvement measures, including Tobacco Cessation Program Metrics; Directs reviews/updates of policies and procedures periodically, as needed. b.Program Manager, Tobacco Cessation (1) Coordinates the development, implementation, management and evaluation of the NMCP Tobacco Cessation Program, using guidelines listed in references (a) through (k). 3 NAVMEDCENPTSVA INSTRUCTION 6200.5A b.Program Manager, Tobacco Cessation (cont) (2) Coordinates and collaborates with the Program Manager, Adolescent Health for the development, Implementation, management and evaluation of the Adolescent Tobacco Cessation Program using American Lung Association Not On Tobacco (N.O.T.) Program guidelines per reference (g). (3) Coordinates the development and implementation of Clinical Guidelines for Prescribing Tobacco Cessation Medication. (4) Coordinates the development, implementation and evaluation of the NMCP Tobacco Cessation Facilitator Training Program using references (a) through (k). (5) Collects and utilizes feedback from program evaluations to perform periodic Needs Assessments and update Performance Improvement standards. (6) Coordinates the development and maintenance of the database identifying current area facilitators. Organizes periodic meetings to provide feedback and updates. (7) Coordinates the collection of NMCP Tobacco Cessation Program outcome measurements and communicates findings to the WDH and NEHC. c.Tobacco Cessation Program Facilitator (1) Achieves satisfactory completion of the Tobacco Cessation Program Facilitator Training per local guidelines. Meets the required standard of facilitating a minimum of two classes per 12 month period to maintain an active status with NMCP Pharmacy. (2) Coordinates and/or implements the Tobacco Cessation Program at Medical Treatment Facilities (MTF), Branch Medical Clinics and/or Fleet and shore Commands. Follows appropriate Guidelines listed in references (a) through (k). 4 NAVMEDCENPTSVA INSTRUCTION 6200.5A c. Tobacco Cessation Program Facilitator (cont) (3) Facilitator participating in classes offering medications must meet the following guidelines: (a) Medical background experience that includes knowledge of patient assessment and screening techniques. (b) If no medical background, Facilitator must coordinate directly with the site Tobacco Champion and/or co-facilitate another facilitator who meets qualifications (c) Maintains knowledge of the local pharmacy policies and Clinical Practice Guidelines for using prescription medication with the Tobacco Cessation Program, as applicable. (d) Communicates with the pharmacy and site provider champion to coordinate the prescription process for the class participants. (e) Assesses participants including current tobacco use amount, medication side effects, effectiveness of medications, and motivation to change behaviors. This includes documentation on appropriate forms and reporting significant findings/concerns to provider champion. (4) Coordinates the scheduling of the classes and provides on-going participant support for class participants during and after class is completed. (5) Submits registration forms, class roster and participant satisfaction survey to NMCP Program Manager, Outcomes and Marketing or clinic site as indicated. Provides appropriate documentation to ensure that the 3 and 6 month follow–up is completed per local site guidelines. (6) Coordinates, as indicated, with Primary Care Manager/Medical provider concerning participant health concerns and relapse management 5 NAVMEDCENPTSVA INSTRUCTION 6200.5A c. Tobacco Cessation Program Facilitator (cont) (7) Follows NMCP and Tobacco Cessation Program guidelines for reporting Adverse Effect(s) d. Designated Primary Care Manager(s)/Provider(s) (Tobacco Champion) (1) Promotes, implements and participates in (MTF), Clinic, Fleet and/or Shore Command Tobacco Cessation Programs according to references (a) through (k). (2) Completes NMCP Tobacco Cessation Program Provider Guidelines for Prescribing Tobacco Cessation Medications. (3) Ensures all adverse reactions are reported per NMCP protocol. (4) Initiates, coordinates and participates in assessment and medication management of participants, before, during and after the Tobacco Cessation class sessions, including relapse management and follow-up. (5) When facilitating Tobacco Cessation classes or 1:1 patient management, follows appropriate guidelines for measuring outcomes required by NEHC. 7.Responsibilities: All NMCP Personnel and facilitators assigned, attached or facilitating the NMCP Tobacco Cessation Program classes will be directed by this instruction, including references (a) through (k) and enclosures (1) through (4). _________________________ 6 Subj: NMCP TOBACCO CESSATION PRESCRIPTION POLICY Ref: (a) NAVMEDCENPTSVA INST 6200.5A POLICY STATEMENT: Medical Officers who are prescribing Tobacco Cessation (TC) Medications for eligible beneficiaries will follow the guidelines in reference a. NMCP and Branch Medical Clinics dispensing the approved Tobacco Cessation medications will require the following procedures be followed. 1. Tobacco Cessation Class Enrollment - The member must be enrolled in a Tobacco Cessation class at the site where the provider is dispensing the prescription and/or be eligible to receive the medication per reference a. 2. Approval - The provider writing the prescription must be on the current list of providers who are approved to write Tobacco Cessation Medications. a. The Wellness Department Tobacco Program Manager will coordinate with the Tobacco Cessation Provider Educator and the NMCP Pharmacy Tobacco Cessation Liaison (PTCL) to maintain an updated list of qualified Tobacco Cessation Providers and Facilitators. b. The NMCP PTCL will ensure that the Branch Medical Clinics (BMCs) and Tricare Prime Clinics (TPCs) receive a current copy of this list monthly. 3. Facilitator Responsibility -The Facilitator of the TC class will provide a list of participants to the Pharmacy at the site where the class is being held, on the NMCP Pharmacy Tobacco Cessation Medication Request form, in person, by e-mail or, if indicated, Fax the information to the Pharmacy. (If NMCP – Fax to 953-0865) 4. Provider Responsibility -The provider will enter the medications directly into CHCS and put in the comment section, “Enrolled in Smoking Cessation Program (dd/mm/yy).” The provider will enter “ Zyban” and the pharmacy staff will be responsible for changing this to Wellbutrin SR 150mg when the patient comes to pick up their medication. 5. Medication Guidelines -The Zyban should be written for a quantity of no more than thirty (30) tabs. The NRT patch should be written for no more than one dosage level at a time. The Nicorette Gum should be written for no more than 2 boxes at a time (one box contains 108 pieces). Enclosure (2a) 7 Subj: NMCP TOBACCO CESSATION PRESCRIPTION POLICY (cont) 6. Ship Guidelines & MDR Responsibilities – The Medical Officer and/or Senior Medical Department Representative is responsible for following all Tobacco Cessation Program guidelines per reference (a). (a) The Tobacco Cessation Facilitator will provide a list of class participants to the NMCP PTCL on the Pharmacy Tobacco Cessation Request Form by personal delivery, e-mail or fax. The list will be submitted at least fourteen days prior to the date needed. (b) The Ship’s provider will enter the medications directly into CHCS and put in the comment section, “Enrolled in Smoking Cessation Program (dd/mm/yy).” The provider will enter in Zyban and the pharmacy staff will be responsible for changing this entry to Wellbutrin SR 150mg when the Ship’s Medical Department Representative (MDR) comes to pick up the medication. (c) Prescriptions will be written as follows: Zyban – a quantity of 60 per patient with one refill; NRT patches – a quantity for the entire course of therapy for each patient; Nicorette Gum – a quantity of 2 boxes with one refill (d) The Independent Duty Corpsman, the Pharmacy Technician or the Medical Officer may pick the Tobacco cessation medications from NMCP Pharmacy. Individual members will not be able to pick up their medications. (e) Deployment – if the Ship is deployed, NMCP Pharmacy will mail the medications directly to the ship. The medications will be stored appropriately and dispensed in 1-2 week doses. (f) Tobacco Cessation (TC) Patients will be assessed and monitored according to reference (a). The TC patients will be monitored for at least four (4) weeks after the prescribed medication is started. Blood Pressure checks will be done at least weekly and documented in the patient’s medical record Enclosure (2b) 8 (Draft) Guidelines for Prescribing Tobacco Cessation Medication 1. Medications will be prescribed for persons attending Tobacco Cessation programs offered or approved by Naval Medical Center Portsmouth and it Branch Medical Clinics as per NAVMEDINST. 6200.5 2. If participant relapses within 12 months of completing Tobacco Cessation program that is documented on SF 600 Tobacco Screening Overprint, a designated provider may screen and prescribe additional medication and provide one on one support. Otherwise, member may need to be referred to another Tobacco Cessation Program. 3. Participant is screened for Zyban or NRT by using the SF 600, Tobacco Cessation Screening Overprint, medical record, and/or appointment with designated provider. Medication guidelines are: Zyban, Wellbutrin, Bupropion HCL ¾ Information not all inclusive-refer to manufacturer’s package insert for complete prescribing information. ¾ Contraindications: o History of Seizure disorder o Current treatment with Wellbutrin, Wellbutrin SR, or any other medications containing Bupropion HCL. Incidence of seizure is dose dependent o Current or prior diagnosis of bulimia or anorexia nervosa o Concurrent administration of a monoamine oxidase inhibitor (MAO) o Allergy to Bupropion o Flight, diving, or other special active duty status o Pregnant or breast feeding ¾ Warnings: Patient factors that may increase risk for seizure o History of head trauma or prior seizure o CNS tumor o Severe hepatic cirrhosis o Concomitant medication that lower seizure threshold ¾ Antipsychotics, antidepressants, theophylline, systemic steroids o Excessive alcohol use or sedatives o Addiction to opiates, cocaine, or stimulants o Use of OTC stimulants and anorectics o Diabetes treated with oral hypoglycemics or insulin ¾ No single dose should exceed 150mg or daily dose of 300mg Enclosure (3a) 9 Zyban, Wellbutrin, Bupropion HCL ¾ Adverse Effects and Recommendations (not all inclusive-refer to manufacturer’s package insert for complete information) o Hypertension-in some cases severe o Tremors – recommend patient discontinue use and contact provider o Most common side effects are dry mouth and difficulty sleeping – may be dose dependent, usually disappears after a few days. Dosage Guidelines: ¾ An initial 2-week supply (30 tablets should be ordered for each new patient. (This may be ordered after the first session of the Tobacco Cessation class.) ¾ Order by typing “ZYB150” into CHCS ¾ Dosage: 150 mg/day for three days then, 150 mg bid up to 12 weeks ¾ Weekly assessment during the program will include a blood pressure check, assessment of effectiveness and presence of any adverse/side effects ¾ Follow-up after the four week program, should include a blood pressure check and interview for effectiveness and presence of any adverse/side effects Nicotine Replacement Patches Information not all inclusive-refer to manufacturer’s package insert for complete prescribing information. ¾ Contraindications: o Hypersensitivity to nicotine or any component of the transdermal system (e.g. Adhesive tape) o Use during the immediate post myocardial infarction period o Life-threatening arrhythmias o Severe or worsening angina pectoris o Pregnancy-category D ¾ Warning: o Systemic Hypertension-monitor for any increase in cardiovascular symptoms ¾ Adverse Effects and Recommendations: o Atrial tachycardia or elevated blood pressure may occur with a combination of patches and Zyban. Discontinue and contact medical for evaluation. o Severe or persistent local skin reactions should be advised to discontinue use and contact physician. Enclosure (3b) 10 Nicotine Replacement Patches o Most common side effects: skin irritation at site of patch-rotate sites to decrease irritation; headache, insomnia, abnormal dreams - removing patch at night may help. ¾ Dosage Guidelines: o If smoking more than 10 cigarettes/day and/or using smokeless tobacco: ¾ Step 1: 21 mg for 2 - 4 weeks, then 14mg for 2 weeks, then 7mg for 2 weeks o If smoking 10 or less: ¾ Step 2: 14mg for 2 - 4 weeks, then 7 mg for 2 weeks o (CHCS order) Nicotine Gum Not all inclusive-refer to manufacturer’s package insert for complete prescribing Information. ¾ Contraindications: o Oral lesions o Hypersensitivity to nicotine o Use during the immediate post myocardial infarction period o Life-threatening arrhythmias o Severe or worsening angina pectoris o Pregnancy-category D ¾ Warning: o Systemic Hypertension- monitor for any increase in cardiovascular symptoms ¾ Adverse Effects and Recommendations: (not all inclusive) o Soreness or lesion in mouth or throat. Discontinue use and see medical. o Most common side effect: Gastric distress. Recommend reviewing proper chewing method and reduction of amount of gum used. Dosage Guidelines: ¾ 2 mg for < 25 cig/day, 4 mg for > 25 cig/day ¾ Dispensed in boxes of 108 ¾ Stop tobacco use completely before starting nicotine gum. ¾ Explain proper use: o when the urge to use tobacco arises, chew one piece of gum slowly until a ‘tingle’ is felt. Enclosure (3c) 11 Nicotine Gum Dosage Guidelines (continued) ¾ Explain proper use: o ‘Park’ gum between cheek and gum o When peppery taste is gone (approx 1 min), chew slowly o When peppery taste returns, park gum in a different place o Repeat until peppery taste is gone (usually ½ hour) o Wrap in paper and dispose of properly ¾ Week 1-6: 1 pc every 1-2 hours ¾ Week 7-9: 1 pc every 2-4 hours ¾ Week 10-12: 1 pc every 4-8 hours Enclosure (3d) 12