Nitrofurantoin is an antibiotic medication used in the treatment of bladder infections. It was not recommended for use in patients with advanced chronic kidney disease (CKD), which is a long-term condition where the kidneys don’t work effectively. As the kidneys wouldn’t work as well as in healthy patients, there were concerns not enough of the drug would reach the bladder for the treatment to work and that there could be more chance of serious side effects. However, feedback from doctors has indicated that a greater range of antibiotics is needed. This, together with two studies in 2013 suggesting nitrofurantoin could be safely and effectively used in patients with more advanced CKD, triggered a review of the current advice on nitrofurantoin use. The MHRA, the UK organisation that regulates medicines, stated nitrofurantoin can now be used for a short time (3-7 days), with caution, in some patients with moderate CKD and with no restrictions in other patients with less severe CKD.
This study aims to review the impact of this updated regulatory advice on nitrofurantoin prescribing before and after the MHRA’s communication and investigate the impact on potential side effects.
The objective of this study is to assess the outcome of the MHRA’s Drug Safety Update (DSU) in September 2014 [1].
This drug utilisation study will utilise an interrupted time series study design in a population of patients prescribed nitrofurantoin between 01/05/2011 and 30/04/2016. Analysis will be performed using an ordinary least-squares regression analysis that accounts for autocorrelation. The primary outcome considered will be the trend in incidence rates of nitrofurantoin prescription in UK primary care in the before and after DSU periods. The primary analysis will compare the trends in prescribing before and after the publication of prescribing advice related to nitrofurantoin use in patients with chronic kidney disease. Two sensitivity analyses will be conducted:
1) Including patients with no record for estimated glomerular filtration rate (eGFR) in the highest eGFR category.
2) Varying the time window around the prescribing in which a test result will be eligible from 1 year before to any time.
The objective of this study is to assess the outcome of the MHRA’s Drug Safety Update (DSU) in September 2014 [1]. This drug utilisation study will utilise an interrupted time series study design in a population of patients prescribed nitrofurantoin between 01/05/2011 and 30/04/2016. Analysis will be performed using an ordinary least-squares regression analysis that accounts for autocorrelation. The primary outcome considered will be the trend in incidence rates of nitrofurantoin prescription in UK primary care in the before and after DSU periods. The primary analysis will compare the trends in prescribing before and after the publication of prescribing advice related to nitrofurantoin use in patients with chronic kidney disease. Two sensitivity analyses will be conducted: 1) Including patients with no record for estimated glomerular filtration rate (eGFR) in the highest eGFR category. 2) Varying the time window around the prescribing in which a test result will be eligible from 1 year before to any time.
Katherine Donegan - Chief Investigator - MHRA
Tracy Turc-Milloy - Collaborator - MHRA
HES Admitted Patient Care