HEALTH SERVICES POLICY & PROCEDURE MANUAL

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Page 1 of 9 PURPOSE To assure that DOP inmates with Pulmonary Diseases are receiving high quality Primary Care for their condition. POLICY All DOP Primary Care Providers and Chronic Disease Nurses are to follow these guidelines when treating inmates with this chronic disease. Deviations from these guidelines are permissible only on a case by case basis. When deviations are made they must be clearly documented in the medical record along with a clear explanation of the rationale for the deviation. PROCEDURE PULMONARY DISEASE (Document care on Pulmonary Flow Chart, DC-815.) 1 Initial evaluation: May be done by Chronic Disease Nurse (CDN) at the first housing assignment after processing. It should be completed within 30 days of arrival at the first housing assignment. If good control should see MD/PA within 60 days of the initial evaluation by CDN, if new diagnoses or partial/poor control must see MD/PA within 15 30 days. A. Vital Signs: Blood pressure and pulse standing and lying, resp. rate, height and weight without shoes, and determine BMI. B. History of Present Illness: Any current symptoms or side effects, compliance with medication. Pulmonary ROS Ask if they are having any chest pain, SOB, edema, cough, sputum production, or exercise intolerance. Also ask about symptoms of anxiety/depression. These conditions are often present in patients with moderate to severe disease, particularly COPD. C. Pulmonary History: When first diagnosed, previous medications and/or treatments, any previous problems with medications, any surgery or hospitalizations. Is there any personal history of asthma, chronic bronchitis, emphysema, COPD, pneumonia, TB or other chronic pulmonary infections, collapsed lung, lung cancer, asbestosis, brown/black lung? What is their immunization status (i.e. influenza and Pneumovax). D. Medications: Complete list of all prescription and OTC medications (ask specifically about aspirin, Goody s Powders, NSAIDS) and herbal remedies they have been taking in the past 6 months. E. Social History: Smoking, alcohol use, illicit drug use, exercise (how much and how often). Occupational history, specifically ask about any work in mining, cotton mills, ship building, or with asbestos. F. Family History: Ask if there is any history of asthma, chronic bronchitis, emphysema, and COPD. G. Physical Exam: Cardiovascular and pulmonary exam plus general if not done within the past 60 days, plus any other areas of concern identified from history. H. Assessment: 1. Good Control: a. ASTHMA = no or minimal SOB, use of rescue inhaler < 2 days of the week, no or minimal impact on activities. b. COPD/CHRONIC BRONCHITIS/EMPHYSEMA = stable symptoms over the past 3 months. 2. Partial control: a. ASTHMA = using rescue inhaler 3 5 days a week, but no serious attacks requiring ER/hospital visits in the past three months. b. COPD/CHRONIC BRONCHITIS/EMPHYSEMA = mild to moderate worsening of symptoms, but no serious attacks requiring ER/hospital visits in the past three months. 3. Inadequate Control = if the above are not met.

Page 2 of 9 I. PFT: If diagnosis or level of control is uncertain and results will help determine correct therapy. J. Peak flow: Do three attempts, encourage maximum effort and record the best result K. Labs: BMP, Hepatic, and Lipid panels; dip stick urinalysis if not done in the past 6 months, have reviewed by MD/PA. L. Educate: Usually it is best to discuss no more then one or two issues at a single visit and/or arrange for separate individual or group educational sessions (Listed in the order of importance) 1. Smoking cessation 2. Proper use of inhalers a. Stress the need to take preventative inhalers (inhaled steroid, long acting beta agonist, anticholinergics, etc. when ordered by MD) on a regular basis. b. Make sick call request if having to use rescue inhalers > 2 days a week for more then 3 weeks in a row. c. Review proper MDI and/or spacer technique. 3. Peak flow use (when ordered by MD/PA) 4. Exercise: a. Goal: 30 60 Minutes of aerobic exercise 5 7 times a week. b. If not doing regularly start with 10 15 minutes and increase by 1 minute everyday or every other day c. Speed: As fast as they can walk without chest pain or severe SOB. Not so fast that they cannot carry on a conversation. 5. Avoidance of aspirin/nsaids M. Assessment/Plan: 1. Asthma: Definition is based on pretreatment symptoms. (See table I for Diagnosis, see Table II for treatment) 2. COPD/Chronic Bronchitis/Emphysema a. Definitions (See Table III for Stages of COPD) 1) COPD: The presence of airway obstruction (FEV 1 /FVC < 70% after bronchodilation) due to chronic bronchitis or emphysema, which is usually progressive and may be partially reversible. Suggestive Features: a) Mid-life onset b) 10 20 or more pack year history of smoking c) Slowly progressive symptoms d) DOE which often progresses to dyspnea at rest 2) Chronic Bronchitis: The presence of chronic productive cough for 3 mouths in each of two successive years where other causes of chronic cough have been excluded. 3) Emphysema: The presence of abnormal permanently enlarged airspaces distal to the terminal bronchioles. b. Therapy (See Table III also) 1) Stage 0: At risk a) STOP SMOKING b) Influenza and pneumococcal vaccines c) Exercise d) Patient Education 2) Stage I: FEV 1 /FVC < 70%, FEV 1 > 80%, ADD: a) Beta 2 -agonist MDI: 1 2 puffs every 2 4 hours not to exceed 12 puffs per day b) No evidence that these drugs alter the long term course of COPD, but they will often help symptoms even if there is no reversible component seen on PFT. 3) Stage II: FEV 1 /FVC < 70% & FEV 1 = 50 80% Consider adding one or more of the following:

Page 3 of 9 a) Ipratropium with or without Beta 2 -agonist MDI: 2 4 puffs 4 times a day either PRN or as a regular prescribed agent or b) Salmeterol: 50 100 ug BID or c) Tiotropium: 1 cap INH qd 4) Stage III: FEV 1 /FVC < 70% & FEV 1 = 30 50% a) Inhaled steroids: consider if the patient has repeated exacerbations b) Oral steroids: Should be avoided in the long term management of COPD c) Dietary Therapy: Consider ordering a dietary consultation for patients who have a BMI < 20 or >30. 5) Stage IV: FEV 1 /FVC < 70% & FEV 1 < 30% or FEV 1 < 50% with chronic respiratory failure a) Oxygen: In the appropriate patient this can both improve the quality and quantity of life b) po2 and O2 Saturation (so2) should be measured via ABG obtained after 30 minutes of normal air breathing c) If resting po2 & so2 do not meet criteria and patient is having severe dyspnea with exercise or sleep, consider measuring po2 or so2 during these times d) Indications for oxygen therapy: 1) po2 < 55 or so2 < 88% 2) In presence of EKG evidence of P pulmonale, hematocrit > 55%, or CHF. po2 = 55 59 or so2 < 89% 3) If patient meets criteria at night or with exercise oxygen should be prescribed for these indications e) Dosage 1) O2 flow rate adjusted so that resting po2 > 60 or so2 > 90% 3. Anxiety/Depression: If the patient has symptoms which are poorly controlled and/or not currently being followed by Mental Health, refer patient to Mental Health for evaluation and/or treatment. N. Convert medications to formulary: If patient enters the system on non-formulary medications convert them to those available on formulary. Consult Central Pharmacy if you need assistance in making the conversion. Non-formulary requests will generally not be approved unless patient has been tried on the formulary agent first, even if current control is good. O. Immunize 1. Pneumovax: Administer if never received in the past. (If over 65 administer if not received since 65 th birthday) 2. Flu: Administer if appropriate time of year. If not, put on reminder list for vaccine. P. Referral: If being seen by Chronic Disease Nurse, refer to or discuss with MD/PA any patient who is having new or worsening symptoms, decrease in physical activity levels, or has a new abnormality or worsening on labs/studies. Q. PULHEAT/Acuity level: PULHEAT AND ACUITY LEVEL ARE TO BE REEVALUATED AT EVERY FOLLOW UP VISIT. Review their current rating and update as indicated. See PULHEAT guidelines for asthma or COPD for guidance. If being seen by Chronic Disease Nurse and she/he feels that there is a need for change in PULHEAT, she/he should review with MD/PA. 2. Follow up evaluations: A. Frequency: Minimum frequency of visits may be more frequent if clinical situation indicates a need for more frequent visits: 1. Good control: See above for criteria. a. Chronic Disease Nurse every 3 6 months b. MD/PA every 6-12 months 2. Partial control: See above for criteria. a. Chronic Disease Nurse every 2 3 month b. MD/PA every 3 6 months

Page 4 of 9 3. Inadequate control: See above for criteria. a. Chronic Disease Nurse every 1 2 month b. MD/PA every 1 2 months B. Vital signs: Check sitting BP (also check standing BP if there are any complaints of dizziness or lightheadedness) and weight. C. Interval history: Ask about the following: 1. Compliance with medications/ medication side effects 2. Level of physical activity: Ask if there has been any decrease since last visit 3. SOB: How often, how severe (rate on a 1 10 scale), duration, what level of activity brings it on 4. MDI use: Ask how many days of the week are they using their rescue inhaler D. Pulmonary review of systems: Ask if they are having any chest pain, SOB, edema, cough, sputum production, or exercise intolerance. Self monitored Peak Flows. E. Other problems Ask if they are having any other problems/symptoms F. Health habits Ask about smoking, exercise, diet compliance G. Review MDI technique: Re-educate if indicated H. Labs/studies: 1. Peak flow Every visit 2. BMP annually if on steroids 3. Hepatic panel annually if on medications 4. Dip stick urinalysis annually 5. PFT as indicated by clinical situation 6. Oxygen saturation annually in stage II or III COPD I. Assessment/Plan: 1. Evaluate control use criteria listed above under Initial Evaluation 2. Evaluate for anxiety/depression are there new symptoms or loss of adequate control of previously existing symptoms J. Education: Review risk factors that have not previously been discussed and/or ones that are on going. Limit to one or two topics per visit K. Referral: If being seen by Chronic Disease Nurse, refer to or discuss with MD/PA any patient who is having new or worsening symptoms, decrease in physical activity levels, or has a new abnormality or worsening on labs/studies L. PULHEAT/Acuity level: PULHEAT AND ACUITY LEVEL ARE TO BE REEVALUATED AT EVERY FOLLOW UP VISIT. Review their current rating and update as indicated. See PULHEAT guidelines for asthma or COPD for guidance. If being seen by Chronic Disease Nurse and she/he feels that there is a need for change in PULHEAT, she/he should review with MD/PA SOR: Deputy Medical Director 10/25/07 Paula Y. Smith, MD, Director of Health Services Date

Page 5 of 9 Table I. Clinical Features Before Treatment 1 CLASS SYMPTOMS 2 NIGHTTIME SYMPTOMS Mild Intermittent Mild Moderate Severe Symptoms < 2 times a week No symptoms & normal PEF between attacks Attacks last few hours to a few days Symptoms > 2 times a week Attacks may affect activity Daily symptoms Daily use of inhaled short-acting b2 agonist Attacks affect activity Continual symptoms Limited physical activity Frequent attacks LUNG FUNCTION < 2 times a month FEV1 or PEF > 80% predicted PEF variability < 20% > 2 times a month FEV1/PEF > 80% predicted PEF variability 20 30% > 1 time a week FEV1/PEF 61 79% predicted PEF variability > 30% Frequent FEV1/PEF < 60% predicted PEF variability > 30% 1. The presence of one of the features of severity is sufficient to place a patient in that category. An individual should be assigned to the most severe grade in which any feature occurs. 2. Patients at any level of severity can have mild, moderate, or severe exacerbations. Some patients with intermittent asthma experience severe and life-threatening exacerbations separated by long periods of normal lung function and no symptoms.

Page 6 of 9 Table II. Stepwise Approach to Drug Therapy in Asthma CLASS I. Mild Intermittent II. Mild III. Moderate IV. Severe DAILY QUICK MEDICATIONS 6 RELIEF 3 None needed Short-acting inhaled B2-agonist Short bursts of PO prednisone if needed 4 Inhaled low dose corticosteroids Inhaled medium dose corticosteroids If needed add long acting B2 agonist Inhaled high dose corticosteroids AND Leukotriene modifier and/or long acting B2 agonist AND If needed PO prednisone 5 EDUCATION Basic facts about asthma Inhaler/spacer technique Role of medications Environmental controls Same as above Same as above Same as above Same as above Self monitoring (peak flow) Develop action plan based on peak flow readings Same as above Same as step III Refer for individual education counseling 1. Step down: Review treatment every 2 to 6 months. If well controlled consider a gradual stepwise reduction in treatment to the lowest level of medications that will control symptoms and maintain lung function. 2. Step up: If control is not adequate or maintained, first review patient medicine technique, compliance, and/or environmental controls. Then if still not controlled consider a step up in therapy. 3. Alternative therapy for quick relief: Nebulizer with albuterol +/- ipratropium maybe be consider as an alternative to MDI particularly in severe attacks or in patients with poor MDI technique. Also Combivent MDI may also be more effective then albuterol alone and maybe considered when albuterol alone is in effective. 4. Burst prednisone: For severe exacerbations and those not improving with bronchodilators alone try a short burst of oral prednisone. Give 40 60 mgs per day for 7 to 14 days +/- a short taper. (Some recent studies have shown that tapers may not be needed for short bursts in asthma). 5. Long term prednisone: Start with 1 mg/kg/day up to 60 mgs then when controlled taper to lowest dose possible. 6. Alternatives: Though not usually considered as first line drugs (generally first line drugs should be tried before these agents) in some selected patients, theophylline or long acting oral B2 agonists maybe be helpful as addons or in replacement of the above. These drugs can be especially useful in controlling night time symptoms.

Page 7 of 9 Table III. Stages of COPD with Treatment Stage Characteristics Treatment 0: At risk Chronic symptoms (cough, sputum) Exposure to risk factors Normal spirometry I: Mild COPD FEV 1 /FVC < 70% FEV 1 > 80% With or without symptoms II: Moderate COPD FEV 1 /FVC < 70% 50% < FEV1 < 80% With or without symptoms III: Severe COPD FEV 1 /FVC < 70% 30% < FEV1 < 50% With or without symptoms IV: Very Severe COPD FEV 1 /FVC < 70% FEV 1 < 30% or FEV 1 < 50% with chronic respiratory failure Avoid risk factors STOP SMOKING Immunizations Exercise training ADD: Short-acting bronchodilator if needed ADD: Regular treatment with 1 or more long-acting bronchodilator Consider dietary evaluation if over or underweight Home exercise program ADD: Inhaled steroid if having repeated exacerbations ADD: Long-term oxygen therapy if indicated by PaO2

Page 8 of 9 Table IV: Management of acute exacerbations of COPD Patient with Known Chronic COPD with two or more of the following cardinal symptoms: 1. Dyspnea or increase in baseline dyspnea 2. Increase in sputum volume 3. Sputum purulence Plus/minus one or more of the following: Cough, malaise, insomnia, sleepiness, fatigue, depression, confusion, decrease in exercise tolerance, or fever Evaluate suitability for outpatient management Hospitalize Not stable Factor Unit/infirm Hospital Able to cope at unit Yes No Breathlessness Mild Severe General condition Good Poor/deteriorating Level of activity Good Poor/bed confined Cyanosis No Yes Worsening peripheral edema No Yes Level of consciousness Normal Impaired Already receiving long-term oxygen No Yes Acute confusion No Yes Rapid rate of onset No Yes Significant comorbidities No Yes SaO2 < 90% No Yes Changes on chest x-ray No Present Arterial ph level > 7.35 < 7.35 Arterial po2 level > 60 < 60 Stable Initial outpatient management: 1. Increase bronchodilator therapy, +/- use nebulizer 2. Consider adding anticholinergic therapy, if not already taking 3. Oral prednisone/ prednisolone for 10 days Does the patient have one of the following: 1. All three of the cardinal symptoms 2. Purulent sputum plus 1 other cardinal symptom No Reevaluate regularly until stable or improving Yes Add antibiotic therapy with one of the following: 1. Amoxicillin 2. Tetracycline/doxycycline 3. Sulfamethoxazole/trimethoprim Alternatives: 1. Amoxicillin/clavulanic acid 2. Macrolides 3. Cephalosporins -- second or third gen.

Page 9 of 9 References Global Initiative for Chronic Obstructive Lung Disease (GOLD), World Health Organization (WHO), National Heart, Lung and Blood Institute (NHLBI). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Bethesda (MD): Global Initiative for Chronic Obstructive Lung Disease, World Health Organization, National Heart, Lung and Blood Institute; 2005. 115 p. [62 references] as summarized by the National Guideline Clearinghouse. Institute for Clinical Systems Improvement (ICSI). Chronic Obstructive Pulmonary Disease. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2004 Dec. 67 p. [118 references] as summarized by the National Guideline Clearinghouse. Chronic obstructive pulmonary disease: Management of chronic obstructive pulmonary disease in adults in primary and secondary care. National Institute of Clinical Excellence. February, 2004. Practical Guide for the Diagnosis and Management of Asthma. Based on the Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma. National Institutes of Health, National Heart, Lung, and Blood Institute. October, 1997. Guidelines for the Diagnosis and Management of Asthma-Update on Selected Topics 2002. Executive Summary of the NAEPP Expert Panel Report. National Institutes of Health, National Heart, Lung, and Blood Institute. June, 2002.