DR-DOT Provider BOOK (DRAFT) 1 TB Basics and Introduction to Drug-Resistant Tuberculosis What is tuberculosis (TB)? TB is a dangerous disease that starts in the lungs. If it remains untreated,TB can spread to other parts of the body. It can spread to bones and joints, the stomach, the throat, the heart, and the brain. TB is very serious and can kill people if left untreated. What is tuberculosis multidrug-resistant tuberculosis (MDR-TB)? Multidrug-resistant TB (MDRTB) is defined as TB resistant to at least isoniazid and rifampicin, the two most potent drugs against TB. MDR-TB is tuberculosis that cannot be treated with the drugs to treat regular TB. What is the difference between TB and MDR-TB? TB and MDR-TB are the same disease. The only difference is that the main drugs to treat regular TB (Isoniazid and Rifampicin) cannot treat MDR-TB. They do not work. MDR-TB needs other medicines that have to be taken for 2 years. Symptoms of TB including MDR-TB Cough Fever Chills Weight loss Chest pain Loss of appetite Fatigue Night sweats Who can get MDR-TB? Everybody can get MDR-TB. Those who are more vulnerable to TB, including MDR-TB are children and adults who cannot fight off illness, people who are already sick or people who do not eat enough nutritious food. Specially those who are not taking drugs regularly are getting MDR TB. How MDR-TB transmitted? MDR-TB, like TB is transmitted by droplets of water in the air. When a person who has MDR TB , coughs, sneezes or talks, he can spray these droplets of water into the air. If someone else breathes in the droplets, he can also get MDR-TB. 2 Who are MDR TB suspects? The followings are the MDR TB suspects. Sputum of all the below mentioned patients must send for Culture and sensitivity test. Cat. 2 failures and relapses Cat.1 failures and relapses Cat. 1 & Cat 2 late converters Cat.1 & Cat. 2 defaults Close contacts of known MDR-TB cases. How MDR TB diagnosed? Diagnosis of MDR TB is done by culture and sensitivity of Sputum. The facilities in the country where culture and sensitivity testing is available are: National TB reference laboratory, NIDCH, Mohakhali, Dhaka Regional TB reference laboratory, General Hospital, Chittagong Regional TB reference laboratory, CDH, Rajshahi Regional TB reference laboratory, CDH, Khulna MDR-TB Treatment MDR-TB medicines must be taken with care. The patients have to take multiple medicines every day. The standard MDR-TB regimen is: 8(Km-Z-Lfx-Eto-Cs)/12(Lfx-Eto-Cs-Z) (Km= Kanamycin, Lfx = Levofloxacin, Z=Pyrazinamide, Eto=Ethionamide, Cs=Cycloserine. ) The numbers in front of the drug abbreviations represent the average number of months the drugs are given. In the Intensive phase five drugs are used and in continuation phase 4 drugs are used Drug* Average daily dosage 33-50 kg 51–70 kg >70 kg (max dose) Pyrazinamide (Z) (400 mg) 30–40 mg/kg daily 1000-1600 mg 1600 -1800 mg 2000-2500 mg Kanamycin (Km) (1 g vial) 15–20 mg/kg daily 500-750 mg 1000 mg 1000 mg Levofloxacin (Lfx) (250 mg, 500 mg) Usual adult dose 1000 mg 750 mg 750-1000 mg 750-1000mg Ethionamide (Eto) (250 mg) 15–20 mg/kg daily 500mg 750 mg 750–1000 mg Cycloserine (Cs) (250 mg) 15–20 mg/kg daily 500mg 750 mg 750–1000 mg For additional information on the DR-TB drugs, please reference Annex 1. In Annex 1, there are drug sheets that provide brief descriptions, along with common side effects and directions on 3 when to provide the medication, for each drug. Annex 2 provides information on how to give an intramuscular (IM) injection. Identifying Side-effects MDR-TB medicines have more side effects than regular TB medications. Urgent Side effects Difficulty Breathing Rash Difficulty Swallowing Swollen Eyes Change in Vision Urgent side effects Difficulty breathing or chest pain Rash Vomiting Difficulty swallowing Jaundice Swollen eyes Swollen tongue Change in vision Hearing loss Jaundice Swollen Tongue Hearing Loss Stomach ache Vomiting blood Depression Acting crazy Chest Pain Pains in the legs Vomiting Ask the patient Are you having difficulty breathing? Are you having chest pain? Do you have a rash anywhere on your body? Have you been vomiting or felt nauseous? Have you had trouble swallowing? Has your skin changed color? Have your eyes been swollen? Has your tongue been swollen Has your vision changed? Can you see as well as always? Can you hear as well as always? If your patient is having urgent side effects, he or she should go to the clinic immediately. If your patient needs help getting to the clinic, do you best to help him or her there. Non-urgent side effects Dizziness Weakness Muscle pain Burning feet or tingling feet or hands Non-urgent side effects Non-urgent side effects Loss of appetite Ask the patient Are you eating well Dizziness Do you feel dizzy? 4 Weakness Do you feel weak? Muscle pain Do you have muscle pain> Burning or tingling in hands or feet Do you feel burning or tingling in uour hands or feet? If your patient is having a non-urgent side effect, he or she should go to the clinic within one week For additional information on DT-TB side-effects, including detailed descriptions of each, please reference Annex 3. DR-DOT Provider: Roles and Responsibilities Summary: 1. Directly Observed Therapy (DOT) 2. Educating patients, their families and the community. 3. Psychological and Social Support 4. Communication skills 5. Be a link between the community and the clinic 6. Noticing needs 7. The Clinical Team Directly Observed Therapy (DOT) Collection of patient’s medicine each month from the pharmacist at the clinic. Storing of medicine in a safe place. Daily home visits to give the patient his/her medicine.. Provide support and encouragement to the patient. Answer questions about medicines and their side effects. Reassure patients who are experiencing normal side effects that the side effects are normal and that they do not need to be concerned. Every day, ask the patient how he or she is feeling. Watch for allergic reactions and urgent side effects to medicines. If those serious signs and symptoms are present, help get the patient to the clinic immediately. Tell patients who are experiencing non-urgent side effects that they should visit the clinic within one week. Fill in the DR-DOT Provider Form for each patient during every visit. Remind patient when she/he has an appointment at the clinic. Educating patients, their families and community Provide accurate information about MDR-TB, including what MDR-TB is and how to live with it, how it is spread, how to prevent it, and how to support patients with MDRTB. 5 Correct people’s misunderstandings or myths about MDR-TB. Encourage household contacts of the patient to get tested for MDR-TB. Educate the community about MDR-TB and encourage those with MDR-TB symptoms to go to the clinic to get tested. Tell people in community that the spread of TB / MDR-TB can be prevented by sunlight, fresh air, medicine, nutritious food, and by people covering theirmouths when they cough. Tips for Teaching DR-TB Information using the Patient Education Flipchart Tips for educating the patient using the Patient Education Flipchart: 1. All material in the Flipchart must be reviewed with the DR-TB patient 2. Place the Flipchart in-between you (the Provider) and the patient, so that both people can see the Flipchart material 3. Emphasis important information to the patient 4. Allow the patients to ask questions any time during the training 5. Clarify any confusing information for the patient while reviewing the information 6. Do not review the patient education material too quickly. Give the patient time to understand what is being covered on each page. Psychological and Social Support Provide patient not only medicine, but also support. Talk with patient each day about his/her life, how s/he is feeling, and any concerns or problems that s/he may have. It can be very helpful to talk about things that do not have anything to do with diseases or medicine. Spend time with the patient and be a good listener. Encourage the patient to seek support from spiritual and religious leaders. Help patients and their family members understand the different psychological and emotional issues related to MDR-TB: shock, denial, fear, loss, grief, shame, guilt, anger, anxiety, low self-esteem, depression, and suicidal thoughts. Recognize signs of depression and thoughts of suicide and know when to seek help from a social worker or doctor. Recognize that children of different ages will respond differently to having MDR-TB. Listen to them and make them feel recognized and special.. Encourage patients to live positively by eating nutritious food, getting enough sleep, exercising, limiting alcohol intake, and taking part in family and community life. Communication skills Remember to use good communication skills when speaking with patients, their family members, or community members. Be respectful. 6 Be empathetic. Take time to listen and be patient. Be caring and not judgmental. Questions that need be full answered, not just “yes” or “no.”This will encourage people to talk. Keep information confidential. Meet children at their level and communicate in a way that is appropriate to their age. Be a link between the community and the clinic Refer patients to the clinic immediately if they have an allergic reaction or urgent side effect from taking medicine. Communicate with the clinic about problems of patients . Let a doctor, nurse, or DR-DOT Provider Supervisor know if patient having problems Things a DR-DOT Provider should never do Never discuss patient information with anyone except the doctor or nurse. Never give other people medicine to give to the Never ask the patient for money or gifts. Never give patients medicine to take by themselves. Never hide information from the doctor or nurse about the patient’s health, problems, or concerns. Home visit checklist ☐Make daily home visits to give the patient their medicine and watch them take it (every day, at the same time, and the right amount). ☐Provide support and encouragement when a patient takes the medicine and explain the importance of taking the medicine every day. ☐Reassure patients who are experiencing normal side effects. ☐Answer questions about medicines and their side effects. Let the patient know if you do not know an answer and then contact the clinic for more information. ☐Everyday, ask patients how they are feeling. ☐Watch for allergic reactions and urgent side effects to HIV/AIDS and TB medicines. If there are signs and symptoms of a bad reaction, help get the patient to the clinic immediately. ☐Recommend that patients who are experiencing non-urgent side effects visit the clinic within one week. ☐Fill out the DR DOT Provider Form for each patient every day. ☐Remind patients when they have an appointment at the clinic. ☐Provide accurate information about MDR-TB as needed ☐Watch out for any signs of depression and thoughts of suicide ☐Spend time with other household members.. ☐Encourage the patient to live positively by eating nutritious food, getting enough sleep, exercising, and taking part in family and community life 7 Annex 1: DR-TB Drug Sheets These are some descriptions of the DR-TB drugs that can help remind you of which drugs to provide DR-TB patients, when to give them, and how to give them (orally, via injection). Use this information as a reference when learning about the different DR-TB drugs. Name: Abbreviation: Dose/KG: Usual Dose: Maximum Dose: When to give drug? KANAMYACIN Km 15 mg/kg/day IMI Adult dosing ranges from 500 mg to 1 gram per day 1500 mg dly IMI Once daily in the morning Side-effects: Cautions: Heating loss; Dizziness or ringing in the ears; Swelling in legs or lack of urination (kidney problems); Pain/redness at injection site; rash Do not use during pregnancy Other: Patients MUST be have blood tests each month to assess creatinine and potassium levels; This drug is given via IM injection Name: Abbreviation: Dose/KG: Usual Dose: Maximum Dose: When to give drug? LEVOFLOXACIN Lfx N/A Dosing varies, in adults doing is 750 to 1000 mg per day 750 mg dly Once daily in the morning Side-effects: Cautions: Other: Pain, swelling or tearing a tendon (back of ankle or elbow); Rash; Severe or bloody diarrhea; yellow eyes (hepatitis) No laboratory monitoring required 8 Name: Abbreviation: Dose/KG: Usual Dose: Maximum Dose: When to give drug? PYRAZINAMIDE Z 20-30 mg/kg/day Dosing varies, in adults dosing is 800 to 2500 mg per day 2 g dly Once daily in the morning Side-effects: Cautions: Yello eyes or skin (Hepatitis); Severe nausea or vomiting with abdominal pain; Painfully inflamed joints (Gout) Avoid in patients with severe liver disease or gout Other: This medicine should be taken with food; Monthly blood tests will need to be condcuted to assess for side effects associated with yellow eyes/skin or if nausea or vomitting develops Name: Abbreviation: Dose/KG: Usual Dose: Maximum Dose: When to give drug? ETHIOAMIDE Eto 15-20 mg/kg/day Dosing varies, in adults dosing is 500 to 1000 mg per day 1000 mg dly Once daily in the morning OR twice daily if side effects develop Side-effects: Yellow eyes/skin (Hepatitis); Severe nausea/vomitting with abdominal pain; Unusual tiredness or fatigue; Unusual loss of appetite; Numbness, pain, or tingling in the hands or feet Cautions: Do not use during pregnancy; Avoid in patients with severe liver disease Other: Monthly blood tests to assess for hepatitis will need to be perfomred; Every 3 to 6 months, blood tests to assess for hypothyroidism needs to be performed 9 Name: Abbreviation: Dose/KG: Usual Dose: Maximum Dose: When to give drug? CYCLOSERINE Cs 10-20 mg/kg/day Dosing varies, in adults dosing is from 500 to 1000 mg per day 1000 mg dly Once daily in the morning OR twice daily if side effects Side-effects: Disoriented thinking, personality changes, or aggressive behavior (Psychosis); Seizures; Shakiness or trouble talking; Numbness, pain, or tingling in hands or feet Cautions: Avoid drinking alcohol while on this drug; Avoid in patients with psychiatric problems Other: No laboratory monitoring requred; Food can modestly decrease the absorption of this drug, therefore, this drug should be taken on an empty stomach Name: Abbreviation: Dose/KG: Usual Dose: Maximum Dose: When to give drug? CAPREOMYCIN Cm N/A Dosing varies, in adults dosing is 500 to 1000 mg/1 g per day 1000 mg dly Once daily in the morning Side-effects: Cautions: Hearing loss; Dizziness or ringing in the ears; Swelling in the legs or lack of urination (kidney problems); Pain/reddness at the injection site Do not use in preganancy (unless absolutely necessary) Other: Patients MUST be have blood tests each month to assess creatinine and potassium levels; This drug is given via IM injection 10 Name: Abbreviation: Dose/KG: Usual Dose: Maximum Dose: When to give drug? PARA-AMINO SALICYLIC ACID PAS 150 mg/kg/day OR 10-12 g/day in 2 divided doses Dosing varies, in adults dosing is 8 to 12 grams per day 12 g/day Once daily in the morning OR twice daily if side effects Side-effects: Cautions: Yellow eyes/skin (Hepatitis); Severe nausea/vomitting with abdominal pain; Black or bloody stools; Unusual tiredness/fatigue; Unusual loss of appetite Avoid in patients with severe liver disease Other: Monthly blood tests to assess for hepatitis will need to be perfomred; Every 3 to 6 months, blood tests to assess for hypothyroidism needs to be performed 11 Annex 2: How to provide an Intramuscular (IM) Injection The pictures below show how to inject into the buttock. Steps 2 through 6 are the same for injections into the arm or thigh. IM injections can be given while the patient is lying on a bed or while standing upright. However, before you can provide an IM injection to a patient, you must practice many times giving an IM injection with the supervision of a nurse or other healthcare provider before you can do so on your own. 1. The person should sit or lie down. Pointing the toes together will relax the muscle to be injected. 4. Before injecting the medicine, gently pull back on the plunger a little bit (do not pull until the plunger falls out). If blood enters the syringe, take the needle out and put it back in somewhere else close by in the area you have cleaned. 2. Clean the skin with alcohol, or soap and water (it will hurt less if you let the alcohol dry before injecting). 5. Pull back on the plunger again. If no blood enters, inject the medicine slowly. 3. Put the needle straight in, all the way. If it is done with one quick movement, it hurts less. 6. Remove the needle and clean the skin again 12 Annex 3: DR-TB Side-effect Descriptions: Burning or pain in the feet and legs (Neuropathy) A number of anti-TB medications can cause abnormal sensations that can develop in the hands and feet. These medications most commonly include: isoniazid and cycloserine. Abnormal sensations in the hands and feet are pain, burning, numbness, tingling, and loss of temperature sensation. Patients with abnormal sensations can experience difficulty walking or with balance. When severe, patients can develop abnormal sensations in their hands and arms, as well as, their feet. Abnormal sensations in the feet and hands can be permanent. Any patient with complaints of abnormal sensations should receive medical attention within one week of developing these symptoms. Notes: Cramping Cramping occurs when a muscle in the body becomes tightened, and therefore, is painful to the patient. Cramping most often occurs in the arms and legs. Cramps often improve on their own. Continued muscle cramping, however, may be a sign of a serious imbalance of essential chemicals in the blood. Cramping due to an imbalance of essential chemicals (electrolytes like potassium) can be fatal if untreated. As a result, muscle cramping always requires immediate medical attention. Notes: 13 Depression Depression is a condition where the patient feels sad or has a low mood. Some anti-TB medications can cause depression, including isoniazid, cycloserine, ethionamide and clofazimine. Patients with depression often develop symptoms that include: decreased interest in things that they previously enjoyed, feelings of guilt, feelings of helplessness or hopelessness, inability to concentrate, difficulty falling asleep or sleeping too much, and decreased appetite or eating too much. Patients can develop thoughts of hurting or killing themselves when depression is severe. Any patient with signs of severe depression should receive immediate medical attention. Any patients with thoughts of suicide need to receive immediate medical attention. Notes: 14 Nausea, Vomiting, and other Digestive Problems Digestive problems are defined as symptoms related to the stomach and intestines, which are organs in the abdomen that help to digest food. Digestive problems are common in anti-TB therapy, with nausea and vomiting being the most common adverse effect. Digestive problems include burning in the stomach or esophagus, an acid taste in your mouth, nausea and vomiting, loss in appetite, diarrhea and generalized abdominal pain. Excessive vomiting, vomiting blood, passing bloody or dark stool, or severe pain are signs of a more severe digestive problem. Digestive problems are usually mild and can be managed with a few helpful hints that the patient should be aware of while taking anti-TB medications: Take a small amount of food (without a lot of fat) before taking the medicines Lay down and rest after taking the medicines Taking anti-nausea medicine, usually 30 to 40 minutes before taking the medicines (the doctor will tell the patient the exact does and type) is very helpful If there is a gastritis (pain in the stomach), the doctor may prescribe some medication for this symptom Sometimes, although rarely necessary, decreasing the doses of anti-TB medications may be necessary. Never do this without instructions from the doctor. Encourage patients that usually with time the nausea and vomiting will get better. The body has a way of adjusting to medications. Remember: some severe digestive problems can be fatal. These include: blood in the stool orvomit, really severe abdominal pain, or bad vomiting that causes the patient to become dehydrated. Patients with symptoms of severe digestive problems should receive immediate medical attention. Patients who vomit up the medications or vomit shortly after taking the medications should also be reported to the doctor. Notes: 15 Fatigue Fatigue is a generalized lack of strength or energy. It is very common during therapy for DR-TB. The specific cause for weakness due to anti-TB therapy, however, sometimes it can be a side effect of the medicine. Fatigue can be associated injury to the thyroid, a gland in the body (hypothyroidism). Fatigue can also be due to anemia. Fatigue is usually not a medical emergency, but the doctor will need to do some blood test to see if the patient has hypothyroidism or anemia. Patients with severe fatigue and symptoms associated with thyroid problems should receive immediate medical attention. Notes: Headaches A headache is an episode of pain or pressure in the head and neck. Headache is a common occurrence during initial stages of therapy for DR-TB. Headache can be associated with nausea and vomiting. Rarely, headache is a symptom of serious infection of the brain. In this situation, it is usually accompanied by neck stiffness, fever and decreased level of consciousness. Headaches due to TB therapy can often be controlled by changes in dosages of anti-TB medication or with medications that help to reduce pain. Headaches that are concerning for brain infection, however, are serious. Patients with these types of headaches should receive immediate medical attention. Notes: 16 Hearing Loss (and dizziness or ringing in the ears) Hearing loss is a decrease in the ability to hear every day sounds. The injectable drugs, in particular, can cause hearing loss. Patients with hearing loss may complain they cannot hear common sounds (like conversations or radio/television broadcasts) as well as they previous could hear these things. Hearing loss is often associated with ringing or buzzing in the ears. The ringing or buzzing can be very disabling for the patient, and this symptom should be taken very serious when a patient complains of it. Patients with hearing loss also can experience difficulties with balance resulting in dizziness (or vertigo). Hearing loss, the ringing in the ears or the dizziness, can be permanent. Patients with signs and symptoms of hearing loss, ringing in the ears, or dizziness should receive immediate medical attention! Often the medications can be adjusted and prevent permanent disability. Patients should be asked every few days if they are having hearing problems, ringing, buzzing in the ears, or dizziness. Remind the patients to report these problems right away. Notes: Irrational Behavior (Psychosis) Irrational behavior is characterized by a variety of thoughts or actions that are not consistent with reality. Irrational behavior is most commonly caused by cycloserine. Patients with irrational behavior (acting crazy) due to anti-TB medications can experience sights and sounds that are not actually present. They can believe strongly in ideas that are not real, including beliefs about their own perceptions and abilities. They can also develop a belief that they are threatened when no threat exists in reality--this is called “paranoia”. Patients can also demonstrate bizarre behaviors, such as exaggerated dress or speech. Severe forms of Irrational behavior can lead to behavior that is dangerous to the patient and others. Patients with signs and symptoms of irrational behavior require immediate medical attention. Patients with psychosis are at risk for suicide and need immediate attention. Notes: 17 Kidney Injury The kidneys are a pair of organs deep in the abdomen, near the upper back. They help to remove wastes from the body by making urine. The injectable drugs, in particular, can injure the kidneys. Kidney injuries often do not have any symptoms until the injury is severe. Severe kidney injury can be associated high blood pressure, swelling of feet and legs, confusion and decrease in the frequency and volume of urination. Blood tests can be used to detect mild kidney injury before it becomes severe. Kidney injury can be irreversible if severe. Any patient with signs and symptoms of kidney injury should receive immediate medical attention. Remember: Rifampin causes the urine to become orange/red in color. This side effect occurs in all people taking rifampin and does not require medical attention. Notes: Liver Injury The liver is an organ in the abdomen that helps to remove wastes from the body. Some anti-TB medications can injure the liver, including isoniazid, rifampin, pyrazinamide, ethionamide and PAS. Patients who use alcohol are at higher risk for liver injury due to anti-TB medications. The signs and symptoms of liver injury include nausea, vomiting, loss of appetite, and a general feeling of being unwell. Patients with liver injury due to anti-TB medications can also experience abdominal pain, often on the right side below the ribs, where the liver is located in the body. If the liver is severely damaged, the white area of the patient’s eyes can appear yellow. The skin of patients with lighter skin tones may also start to appear yellow. Blood tests can be used to detect mild liver injury before it becomes severe. Severe liver injury can be fatal. Any patient with signs and symptoms of liver injury should receive immediate medical attention. Notes: 18 Rash A rash is any change in the appearance of the patient’s skin. Many types of anti-TB medications can cause a rash. A rash may develop as patches, bumps, or blisters on the skin. Rashes can also appear as a redness or darkening of skin. Rashes generally appear on the arms, legs, and trunks of the body. The rash may or may not itch. In severe cases, patients with rash may also experience swelling of the lips, tongue and throat, which can progress to difficulty with breathing. A rash that has blistering or peeling of the skin is also more severe. Severe forms of rash can be fatal. Any patient with signs of a rash due to anti-TB therapy should receive immediate medical attention. Notes: Seizures A seizure is a sudden, abnormal activity of the brain. It often occurs in the form of convulsions, which is uncontrolled shaking of the body. Anti-TB medications, such as isoniazid, cycloserine, levofloxacin and moxifloxacin, can cause seizures. A seizure can be associated with a loss of consciousness and involuntary loss of bowel and bladder control. Patients are often in a confused state following a seizure. Seizures can last for seconds to minutes and often cease on their own. Severe seizures, however, may not stop unless medications are administered. A severe seizure can result in permanent brain damage or cause death. Any patient with signs and symptoms of a seizure requires immediate medical attention. Notes: 19