Assessment of implementation of antibiotic stewardship program in surgical prophylaxis at a secondary care hospital in Ras Al Khaimah, United Arab Emirates.

Antibiotic overuse is a major factor for causing antibiotic resistance globally. However, only few studies reported the implementation and evaluation of antimicrobial stewardship programs in Gulf Cooperation Council. This study was conducted within 8-months periods to evaluate the effect of the newly implemented antibiotic stewardship program on improving the prescribing practice of surgical antibiotic prophylaxis in a secondary care hospital in the United Arab Emirates by releasing local hospital guidelines. The data of 493 in patients were documented in the predesigned patient profile form and the prescribing practice of surgical antibiotic prophylaxis for clean and clean-contaminant surgical procedures was compared and analyzed two months' prior (period A) and post (period B) the implementation of antibiotic stewardship program. The 347 patient's data (PD) were analyzed during period A and 146 PD during period B. The prescription of piperacillin/tazobactam was decreased from 2.4% from all surgical prophylaxis antibiotic orders in period A to 0% in period B. The appropriateness of the antibiotic therapy was found to differ non significantly for the selection of prophylactic antibiotic (p = 0.552) and for the timing of first dose administration (p = 0.061) between A and B periods. The total compliance was decreased non significantly (P = 0.08) from 45.3 to 40.2%. Overall, the guidelines have improved the prescribing practice of antibiotics prior to surgery. However, further improvement can be achieved by initiating educational intervention via cyclic auditing strategy.

Lesson Learnt from Recall of Valsartan and Other Angiotensin II Receptor Blocker Drugs Containing NDMA and NDEA Impurities.

The presence of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) impurities in angiotensin II receptor blocker (ARB) drugs containing tetrazole ring has triggered worldwide product recalls. The purpose of this article is to identify the potential gap area in current pharmaceutical industry practice that might have led to the NMDA and NDEA impurities escaping the drug manufacturer's and FDA's attention. The impact of process change was not adequately assessed by the manufacturer of contaminated APIs (active pharmaceutical ingredients), and potential for generation of mutagenic or other toxic impurities was not considered. The safety and risk associated with a chemical synthetic process was also not evaluated. This is primarily due to current industry practice which focuses on controlling the impurities above reporting threshold. ICH Q3A and FDA guidance on genotoxic and carcinogenic impurities in drug substances and products need to be integrated so that the ICH Q3A decision tree (attachment 3) begins by checking whether the synthetic process has been evaluated for the potential to generate toxic impurities. The compliance with ICH Q3A limits should be carried out only after the process has been determined to be safe without the risk of generating mutagenic and carcinogenic impurities.