RESUMEN
Background: Good Manufacturing Practices (GMP) is the bedrock of quality assurance in the pharmaceutical industry that ensures that products are consistently produced and controlled according to quality standards. This study compared the GMP conformance of pharmaceutical facilities across two fiscal years, 2018/2019 and 2019/2020, using the East African GMP Compendium on Good Manufacturing Practices, 2014, as a benchmark. Methods: We analyzed the proportion of conformance of foreign pharmaceutical industries to GMP standards and reported the aggregated data over a two-year period. Results: Inspected facilities had notable non-conformances, most commonly related to laboratory quality control and premises. We noted a downward trend in conformance in 2019/2020 compared with 2018/2019, with only 32.9% of facilities adhering to EAC GMP requirements, down from 50% in the previous year. The COVID-19 pandemic has affected the ability to conduct on-site inspections, and may have contributed to the lower conformance rate. Conclusions: These findings underscore the crucial need to continue GMP inspections and the importance of taking corrective actions to ensure adherence to the quality standards for products marketed in Tanzania. The study further revealed the significance of desk reviews in assisting regulatory authorities in facing unforeseen challenges such as pandemics.
RESUMEN
Objective: Surveillance of antimicrobial consumption is essential to the national action plan for antimicrobial resistance (AMR) as stipulated in the Global Action Plan on AMR and the Tanzanian National Action Plan on AMR. Given the paucity of antimicrobial consumption data in sub-Saharan Africa region, the objective of this study was to measure antimicrobial consumption in Tanzania. Methods: From 2017 to 2019, data on all antimicrobials imported into Tanzania were obtained from the Tanzania Medicines and Medical Devices Authority Data, augmented with purchasing data from the Medical Stores Department and data from local manufacturers. Data were collected and analyzed in accordance with the World Health Organization Anatomical Therapeutic Chemical and defined daily doses (DDD) methodology. Results: The average DDD per 1,000 inhabitants per day (DDD/1,000/D) for all antimicrobials was 80.8 ± 39.35. The DDD/1,000/D declined from 136.41 in 2017 to 54.98 in 2018 and 51.02 in 2019. Doxycycline, amoxicillin, and trimethoprim-sulfamethoxazole were the most frequently consumed antibiotics during these years, accounting for 20.01, 16.75, and 12.42 DDD/1,000/D, respectively. The majority of antimicrobial consumption in Tanzania occurred in the private sector, with the proportion of private-sector antibiotic consumption increasing annually from 2017 to 2019. Based on AWaRe classification >90% of antimicrobial consumption was Access class medications, with Watch and Reserve class medications accounting for <10% and <1%, respectively. Conclusion: The private sector use of antimicrobials is significantly increasing and should be carefully monitored in accordance with national policies. Future work is necessary to increase reporting of antimicrobial consumption patterns in sub-Saharan Africa.