SETTINGS: Three institutes, 11 hospitals and 38 community hospitals in southern Thailand. OBJECTIVES: To assess the quality of tuberculosis (TB) drugs used in TB treatment facilities in southern Thailand and their TB drug management systems. DESIGN: Cross-sectional study utilising interviews, document review, inspection of drug storage, visual examination of TB drugs, and laboratory analysis of samples of isoniazid (INH), rifampicin (RMP), pyrazinamide (PZA) and ethambutol (EMB). RESULTS: No stock-out of TB drugs was found at any level. Thirteen (25%) hospitals/institutes removed coated EMB tablets from their foil packages for daily dose packing. Eleven (21%) hospitals/institutes bisected 400 mg coated EMB tablets before dispensing as a non-available 200 mg tablet. On the day of inspection grossly deteriorated EMB was observed in 44% of hospitals/institutes. All samples, except 14% of EMB, passed content assay tests. All INH and EMB samples passed the dissolution tests, but 62% of RMP samples and 26% of PZA samples failed. CONCLUSIONS: Sub-standard deteriorated TB drugs are a serious problem for TB control. TB drugs examined in the study area were not managed properly. Education on TB drug packaging and storage, and non-destructive systems in TB drug distribution, storage, inventory control, quality assurance and supervision are essential interventions.
SETTINGS: Three institutes, 11 hospitals and 38 community hospitals in southern Thailand. OBJECTIVES: To assess the quality of tuberculosis (TB) drugs used in TB treatment facilities in southern Thailand and their TB drug management systems. DESIGN: Cross-sectional study utilising interviews, document review, inspection of drug storage, visual examination of TB drugs, and laboratory analysis of samples of isoniazid (INH), rifampicin (RMP), pyrazinamide (PZA) and ethambutol (EMB). RESULTS: No stock-out of TB drugs was found at any level. Thirteen (25%) hospitals/institutes removed coated EMB tablets from their foil packages for daily dose packing. Eleven (21%) hospitals/institutes bisected 400 mg coated EMB tablets before dispensing as a non-available 200 mg tablet. On the day of inspection grossly deteriorated EMB was observed in 44% of hospitals/institutes. All samples, except 14% of EMB, passed content assay tests. All INH and EMB samples passed the dissolution tests, but 62% of RMP samples and 26% of PZA samples failed. CONCLUSIONS: Sub-standard deteriorated TB drugs are a serious problem for TB control. TB drugs examined in the study area were not managed properly. Education on TB drug packaging and storage, and non-destructive systems in TB drug distribution, storage, inventory control, quality assurance and supervision are essential interventions.
Authors: Merrin E Rutherford; Rovina Ruslami; Melissa Anselmo; Bachti Alisjahbana; Neti Yulianti; Hedy Sampurno; Reinout van Crevel; Philip C Hill Journal: Bull World Health Organ Date: 2013-09-10 Impact factor: 9.408
Authors: Sachiko Ozawa; Daniel R Evans; Sophia Bessias; Deson G Haynie; Tatenda T Yemeke; Sarah K Laing; James E Herrington Journal: JAMA Netw Open Date: 2018-08-03