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Pitfalls In Management Systems And Quality Of Anti-tuberculosis Drug In Lower Southern Thailand

Pitfalls In Management Systems And Quality Of Anti-tuberculosis Drug In Lower Southern Thailand Korngamon Rookkapan et.al. Introduction. Anti-tuberculosis drugs (ATBDs) are important weapons for treat & control TB Improper handling ATBD may lead to MDR-TB

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Pitfalls In Management Systems And Quality Of Anti-tuberculosis Drug In Lower Southern Thailand

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  1. Pitfalls In Management Systems And Quality Of Anti-tuberculosis Drug In Lower Southern Thailand Korngamon Rookkapan et.al

  2. Introduction • Anti-tuberculosis drugs (ATBDs) are important weapons for treat & control TB • Improper handling ATBD may lead to MDR-TB • Pilot study revealed deteriorated* ATBDs • visual inspection: 1/3 hospitals • reported: 7/13 hospitals, 2/7 PHOs#, 2/2 TB centers • interview TB patients: 9/51 of TB patients • This information needs verification along with management evaluation * deteriorate: denature while expiry date is not reach # PHO : Provincial Health Office

  3. Objectives 1. To systematically verify deterioration of ATBDs 2. To evaluate management systems of ATBDs 3. To workout the solutions

  4. Methodology • Study design: cross-sectional survey & qualitative study • Settings: facilities involved in treatment and supply of ATBDs at national, regional, provincial, and district levels • Methods: laboratory analysis of ATBDs, grossly inspection, document review, questionnaire interview, in-depth interview, observe ATBD inventories • Informants: ATBD managers, TB patients

  5. LQAS, n=52: TB cluster, office of disease control, TB center, 7 PHOs*, 7 general hospitals, 2 regional hospitals Sampling 69 community hospitals 38 community hospitals -Interview ATBD managers -inspect ATBD inventories Interview 5 TB patients/hospital Sampled 50 tablets each of R E, Z, H from dispensing shelf to laboratory analysis Sample size *PHO: Provincial Health Office

  6. Results: deteriorated ATBDs Stained E at the bottom of paper box Discolor Z majority showed abnormal dissolution Normal Z Even non-sticky one had reduce content PAS with broken surface E with sticky coated

  7. Deteriorated ATBDs Methods of Facilities found deteriorated data collection ATBDs/Total facilities R E Z H Any drug Interview manager 6/52 27/5228/52 16/52 44/52 Gross inspection 1/52 23/529/52 2/52 28/52 Content 0/50 7/51 0/46 0/51 7/52 Dissolution 31/500/51 12/46 0/51 38/52 Interview patient - - - - 44/280(15.7%)

  8. Transportation Management factors (number of facilities) Dispensing Storage Sunlight shone out to drug storage (5) Non-light nor moisture resistant package (25) sink near drug shelf (19) Not using FIFO system (20) Containing expired drug in stock (12) Temperature>30ο C (7) Poorly sealed package (32) Humidity >75%RH (15) Transparent plastic bag for R300 (51) Remove coated E from foil (13) Biseceted coated E (11)

  9. What had been done? • Sampled ATBDs from all over Thailand to analyze without charge • Facilitate return deteriorated ATBDs with re-supply new drugs • Involve other discipline (pharmacist) in monitoring drug storage, inventory control, and dispensing • Educate ATBD managers regarding storage, packaging

  10. Lessons learn • Sub-standard ATBDs is a serious problem • ATBDs in study area were not managed properly • We have to improve system of drug management which include transportation, storage, dispensing and attitude. These need multi-disciplinary effort

  11. Policy & Research • Further improvements and policy are urgently needed to • develop drug management standard by interactive workshop with ATBD managers, policy makers, TB control person • strengthen drug quality assurance • improve supervision standard • Future research: • Quality assurance of anti-retroviral • Develop and test quality assurance model of drugs for communicable diseases

  12. Logistics chain of ATBD Manufacturer TB cluster Office of disease control TB center PHO* Hospitals:3 provinces Hospitals:4 provinces National level Regional level Provincial level District level *PHO: provincial health office Health centers Patients

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