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International Journal of Pharmacy Teaching & Practices 2013, Vol.4, Issue 2, supplement II, 666-669. A Prospective Descriptive Study on the Drug Classification and Medication History from Tuberculosis Children Outpatients in Dr. M. Djamil Hospital, Padang-Indonesia * Dian Ayu Juwita*, Helmi Arifin*, Finny Fitri Yani**, Deswinar Darwin* Faculty of Pharmacy, University of Andalas, ** Faculty of Medicine, University of Andalas Introduction Case Series * * Please cite this paper as: Dian Ayu Juwita , Helmi Arifin , Finny Fitri ** * Yani , Deswinar Darwin . A Prospective Descriptive Study on the Drug Classification and Medication History from Tuberculosis Children Outpatients in Dr. M. Djamil Hospital, Padang-Indonesia. IJPTP, 2013, 4(2), supplement II, 666-669. Corresponding Author: Dian Ayu Juwita Faculty of Pharmacy, University of Andalas, Kampus Limau Manis, Padang 25163 Tel 0751-71682 Fax 0751-777057 Email: [email protected] Abstract To investigate and analyze the drugs classification, phase of therapy, and medication history from children outpatients of tuberculosis. The study was conducted by the method of prospective and analyzed descriptively on a limited population for 4 months. Over 57 patients observed, the percentages of patient in each phase of therapy were 42.1% for intensive phase and 57.9% for extended phase of therapy. The identification of drugs that were used reveals that isoniazid was used in 44.31% of patients; rifampicin in 43.41%, pyrazinamide in 11.07% and ethambutol in 1.19% of patients. Anti-tuberculosis drugs were used in single medication in 0%; two-drug combination in 56.1%; and three-drug combination in 43.8% of patients. The medication history taking showed that 98.25% of the cases were new cases; 0% was relapse case; 1.75% was drug withdrawal case; and 0% was medication failed case. TB treatment in children outpatient in DR. M. Djamil Hospital Padang has in accordance with standard children’s TB therapy is using a combination of antituberculosis drugs are tailored to the patient phase of therapy. Anti-Tuberculosis drugs most commonly used are Isoniazid, rifampicin and pyrazinamide, where everything is a first-line anti-TB drugs. Keywords: tuberculosis children outpatient, anti-tuberculosis drugs, anti-TB drugs classification, medication history, phase of therapy Acute Tuberculosis (TB) has been the leading cause of death for infectious disease in children and adults (1,2,3) . In Indonesia, tuberculosis is a primary health problem in terms of mortality, morbidity, diagnosis (3) and treatment . Indonesia ranks third among TB high-burden countries after India and China with approximately 539,000 new cases and (2) approximately 101,000 deaths per year . Around 10-15% of all cases occur in children aged < 15 years (3,4) . Increased number of tuberculosis incidence in various places is thought to be triggered by several causes including: improper diagnosis, inadequate treatment, unsuccessful prevention programs, the infection of HIV/AIDS, drug resistance, increased (3,5) poverty, and inadequate health services . Children’s Tuberculosis is a problem that cannot be ignored, because it is a systemic disease that can affect almost any organ, causing malnutrition and disturbance in daily activities. Severe TB can lead to lung and other organ defects. Without proper diagnosis and management, TB is most likely to cause a high mortality rate and the infected children (6,7) can be the source of future infection . The management of TB in children is a unity between the provision of medical intervention, nutritional management and treatment of (2) . In contrast to adults, Anticomorbidities tuberculosis drugs (Anti-TB Drugs) in children are not given two or three times a week but given every day, so children need to be given extra attention both on the intensive phase and the extended phase because they cannot regulate their own treatment, (3,8) . and improper treatment can cause resistance The treatment should be based on a rational and appropriate therapy to the treatment phase as well as the patient's medical history in order to achieve optimal clinical objectives. The use of drug can be stated rational if the drug is used as indicated, considers the patient's condition, appropriate drug selection, consider the benefits and risks for the (9,10) . patients The present study was conducted to determine the type and combination of anti-tuberculosis drugs used in the DR. M. Djamil Hospital Padang, the phase of treatment and to take the patient 666 International Journal of Pharmacy Teaching & Practices 2013, Vol.4, Issue 2, supplement II, 666-669. medication history. This study is expected to be be a reference data to prevent and minimize the problems that occur in children as well as improving the success of TB treatment in children. Material and Methods The study was conducted prospectively and analyzed with descriptive method. The study population included all children outpatients diagnosed with TB who were in the treatment at the DR. M. Djamil Hospital Padang from April to July 2010. Data sources were medical records of pediatric patients undergoing TB treatment, medical records and laboratory test results. The collected data were then transferred to the data collection sheet and analyzed descriptively which included phase of therapy, type of drug, drug combinations and medication history. Results and Findings Table 1. Observations in pediatric patients with the diagnosis of tuberculosis Observation Quantity Percentage Characteristics (%) Phase of therapy a. Intensive phase 24 42.1 therapy 33 57.9 b. Extended phase therapy Type of Anti-TB Drugs A. First-line Drugs a. Isoniazid 148 44.31 b. Rifampicin 145 43.41 c. Pyrazinamide 37 11.07 d. Ethambutol 4 1.19 B. Second-line Drugs 0 0 Drugs combination a. Single medication 0 0 b. Two-drug 25 56.1 combination 32 43.8 c. Three-drug combination The medication history a. New cases 56 98.25 b. Relapse case 0 0 c. Drug withdrawal 1 1.75 case 0 0 d. Medication failed case Discussion and Conclusion From 216 pediatric patients who visited the DR. M. Djamil Hospital Padang during April to July 2010, 57 of them were diagnosed with tuberculosis and receiving anti-TB drug therapy. The survey results revealed that TB treatment with drug combination had been applied to the treatment of Tuberculosis children outpatient in DR. M. Djamil Hospital Padang, which can be seen from the absence of patients treated with a single anti-TB drug. A total of 56.1% of patients received 2 anti-TB drugs combination, while 43.8% receive 3 drugs combination. Types and combinations of drugs used had also been adjusted based on the patient’s phase therapy. Patients receiving 2 drugs combination therapy were much more because 57.9% of the total TB patients underwent extended phase therapy, whereas 42.1% of patients were in the intensive phase therapy. TB treatment is divided into two phases: the intensive phase (2 months) and the extended phase (2) (4 Months) . The principle of treatment using a combination at least 3 kinds of drugs in the intensive phase, followed by 2 kinds of drugs in the extended (2,11) . Provision phase and given daily for 6-12 months of a combination of drugs and in the long term than to kill all the TB germs also to reduce the likelihood (3) of recurrence . Intensive phase is useful for destroying populations of acid-fast bacilli (AFB) quickly, while the extended phase to eliminate the (3) rest of the dormant AFB . Types of anti-tuberculosis drugs most commonly used were isoniazid and rifampicin. This is because both of these drugs are important drugs for treating all types of tuberculosis, and are used both in intensive phase and extended phase. Isoniazid and rifampicin are the most effective drugs, relatively non-toxic, easily administered, and the price is not (12,13) . expensive The action of anti-tuberculosis drugs is based on three mechanisms: the killing activity, sterilizing activity, and preventing resistance. Isoniazid is the most potent drug in killing bacteria rather than rifampicin and streptomycin, and is bactericidal and very effective against bacteria in a state of active metabolic (growing bacteria), and is bacteriostatic (5,12) . against dormant germs Rifampicin and pyrazinamide are the most potent drugs in sterilizing mechanism. Rifampicin is bactericidal against the bacteria that directly penetrates most tissues and phagocytic cells. Rifampicin can kill organisms that are resistant to many types of drugs, such as intra-cell organisms and which are in the abscess cavity and lungs, while pyrazinamide is active sterilization agent to fight the remnants of organisms in the cell that can lead to (12,14) . relapse The least Anti-TB drug prescribed in the treatment of tuberculosis in Dr. M. Djamil Hospital Padang was ethambutol, with the percentage of 1.19%. This drug is not widely used in the treatment of children tuberculosis because ethambutol is not recommended for general use in children as it can cause neuritis retrobuller which could result in loss of visual acuity and red-green color blindness. But the administration of this drug should be considered in children with severe and drug resistant 667 International Journal of Pharmacy Teaching & Practices 2013, Vol.4, Issue 2, supplement II, 666-669. tuberculosis if other drugs are not available or cannot be used (13,15) . The entire prescribed drugs were first-line anti-TB drugs and there was no indication for the administration of second-line drugs. The second-line anti-TB drugs include streptomycin (S), Para-amino salicylic acid (PAS), ethionamide, ofloxacin, levofloxacin, ciprofloxacin, kanamycin, etc. First-line drugs are better in efficacy and safety rather than second-line drugs. With these drugs, the tuberculosis patient can be cured. Second-line drugs are considered to use if the resistance arises with the first-line drugs, hence those drugs are replaced with at least 2-3 second-line drugs which are known to remain potential, so the patient received 5 or 6 drugs at once. However, second-line drugs have not been approved for use in children regarding the low efficacy and the risk of toxicity in (2,12,13,16) . children A total of 56 cases out of 57 cases of TB occurred in Dr. M. Djamil Hospital Padang were new cases. In which the patients have not been treated with anti-TB drugs or have been prescribed the drugs for less than one month (30 days). While one patient was drug withdrawal case (treatment after dropout/default), in which the treatment of patients who had at least 1 month of treatment and stopped for 2 months or more then come back for treatment. After interviewing the parents, it was known that the patient experienced drug withdrawal since 4 months before, because the parents went out of town so that no one gave anti-TB drugs to the patient. This problem is likely to happen due to less education for families about TB and its management. Patients and parents do not know about the long-term TB treatment, regular, and should not be interrupted, and do not aware of the potential risk of breaking the rule. Therefore it is strongly recommended to educate the patients and parents on the significance of completing the treatment to the end in order to avoid resistance and prevent recurrence. Once the resistance happens, the treatment will (3,17) . be more difficult and require longer time This study concludes the following: 1. TB treatment on children outpatients in DR. M. Djamil Hospital Padang was in accordance with standard children’s TB therapy in which the combination of anti-tuberculosis drugs are adjusted based on the phase of the therapy. 2. Anti-Tuberculosis drugs most commonly used were isoniazid, rifampicin and pyrazinamide, that are all included in first-line anti-TB drugs. 3. From the patient's medication history, it was still found the children TB patient experiencing drug withdrawal. References 1. Salazar, G.E., Schmitz, T.L., Cama, R., Sheen, P., Franchi, L.M., centeno, G., Valera, C., Leyva, M., Montenegro-James, S., Oberhelman, R., Gilman, R.H., Thompson, M.J. & the working group on TB in Peru., 2001. Pulmonary Tuberculosis in Children in a Developing Country. Pediatrics, 108(2), h.448-6 2. Departemen Kesehatan Republik Indonesia. 2006, Pedoman Nasional Penanggulangan Tuberkulosis, Edisi 2, Cetakan ke-1. Jakarta: Departemen Kesehatan Republik Indonesia. 3. Rahajoe, N.N., Basir, D., Makmuri, M.S., Kartasasmita, C.B., 2008. 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Aslam M., Tan C.K., Prayitno A., 2000, Farmasi Klinis : Menuju Pengobatan Rasional dan Penghargaan Pilihan Pasien. Penerbit PT Elex Media Komputindo Kelompok Gramedia. Jakarta. 10. Trisna Yulia., 2004., Idealisme Farmasis Klinik di Rumah Sakit. Pengantar Farmasi Klinik. Jakarta. 11. Sunarjo, D., 2007, Tuberkulosis Pada Anak (Diagnosis dan Tatalaksana), SMF Anak BRSD RAA, Soewondo Pati. http://www.google.com.diakses Januari 2010. 12. Katzung BG., 2004. Farmakologi Dasar dan Klinik. Edisi 8. Bagian Farmakologi Fakultas Kedokteran Universitas Airlangga. Penerbit Salemba Medika. Surabaya. 13. Munoz, F.M. & Starke, J.R., 2004. Tuberculosis (Mycobacterium Tuberculosis). Dalam : R.E. Behrman, R.M. Kliegman, H.B. Jenson, penyunting. Nelson Textbook of Pediatrics. Edisi ke-17. Philadelphia : Saunders. 14. Gunawan, S.G., 2007. Farmakologi dan Terapi, Edisi ke-5, Departemen Farmakologi dan Terapeutik Fakultas Kedokteran Universitas Indonesia. Gaya Baru. Jakarta. 15. Rahajoe, N.N., Supriyatno, B., Setyanto, D.B., 2010. Buku Ajar Respirologi Anak. Edisi Pertama. Badan Penerbit IDAI. Jakarta. 16. Muchtar, A., 2006. Farmakologi Obat Anti Tuberculosis (OAT) Sekunder. Departemen Farmakologi dan Terapeutik FKUI/Departemen Farmakologi Klinik RSCM, Jurnal Tuberkulosis Indonesia, 3(2), h.23-29. 17. Drobac, P.C., Mukherjee, J.S., Joseph, J.K., Mitnick, C., Furin, J.J., Castillo, H.D., Shin, S.S. & Becerra, M.C., 2006. Community-Based Therapy for 668 International Journal of Pharmacy Teaching & Practices 2013, Vol.4, Issue 2, supplement II, 666-669. Children With Multidrug-Resistant Tuberculosis. Pediatrics, 117, h.2022-8. AUTHORS’ CONTRIBUTIONS Authors contributed equally to all aspects of the study. PEER REVIEW Not commissioned; externally peer reviewed. CONFLICTS OF INTEREST The authors declare that they have no competing interests. 669