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A review of Controlled Drug incidents reported to the NRLS over seven years

By David Cousins, David Gerrett and Bruce Warner



To describe the number and types of patient safety incidents involving Controlled Drugs reported to the National Reporting and Learning System (NRLS) and the role of Accountable Officers for CDs (AOs) in incident reporting and learning.

Design and setting

All medication safety incidents concerning CDs reported from the NHS in England and Wales occurring in the seven years from 1 January 2005 to 31 December 2011 were extracted from the NRLS and subject to quantitative inspection. In addition incidents with reported outcomes of death and severe harm were also analysed qualitatively.


There were 72,028 in incidents reported to the NRLS over seven years. Of 10,678 incidents of reported harm, there were 54 deaths, 74 severe harms and 10,550 incidents of other harms. The risk of death with CD incidents was found to be significantly greater than with medication incidents generally (odds ratio 1.484, 95% CI 1.015–2.169). Incidents involving overdose of CDs accounted for 89 (69.5%) of the 128 incidents reporting of serious harm (death and severe harm). Five CDs (morphine, diamorphine, fentanyl, midazolam and oxycodone) were responsible for 113 incidents (88.4%) leading to serious harm. A detailed review of the 128 incident reports associated with serious harm found that only once incident had been referred to the AO.


Unsafe use of CDs is the number one cause of serious harm from medication incidents reported to the NRLS; in our view, better implementation of NPSA guidance could have prevented most of these incidents from harming patients. The role of the AO should prioritise reporting and learning of incidents that have caused serious harm.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11125507

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