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Implications for safer practice of CD incidents reported to the NRLS

Seven years’ worth of Controlled Drugs incident reports have been reviewed by the National Reporting and Learning System and the results used to inform safer practice

In a previous review of all medication incidents reported to the National Reporting and Learning Service (NRLS), opioid medicines were identified as causing the greatest number of incidents with fatal and severe outcomes. The National Patient Safety Agency issued guidance intended to help minimise dosing errors with opioid medicines.

Controlled Drugs are subject to special legislative controls because there is potential for them to be abused or diverted, or cause possible harm.

In response to the Shipman Inquiry Fourth Report, the Government introduced a range of measures to strengthen the systems for managing CDs to minimise the risks to patient safety of inappropriate use. The arrangements were underpinned by the Health Act 2006 and The Controlled Drugs (Supervision of Management and Use) Regulations 2006 made under the provision of the Act.

Accountable Officers (AOs) were given specified responsibility to minimise the risk to patients from CDs. The regulations indicate that, in discharging their responsibilities, AOs must have regard to best practice in relation to the management and use of CDs.

We have undertaken a quantitative review of all medication incidents involving CDs sent to the NRLS over a seven-year period. In addition, for those incidents with reported outcomes of death and severe harm we have undertaken a qualitative review. Our aims were to improve our understanding of the types of incidents and the role of AOs in reporting and learning.


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

Those incidents identified as causing serious harm were inspected for underlying themes. The full dataset was filtered for occurrence of the words “Accountable Officer” or “AO” and the resulting subset inspected and grouped under the themes identified for incidents associated with death or severe harm. The role of the AO was reviewed in all incidents where death or severe harm occurred.


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 as a serious harm with CD incidents was found to be significantly greater than with medication incidents generally [odds ratio 1.484, 95 per cent confidence interval 1.015–2.169].

The largest type of error category was “Other”. Some 22,890 incidents (31.8 per cent) were not allocated to common patient safety categories by the reporters. Inspection of these reports indicated that errors in CD documentation and storage were the most common frequently reported types of incident in this category. Wrong or unclear dose received the next largest number of incident reports 7,142 (14.8 per cent).

Incidents involving overdose of CDs accounted for 89 (69.5 per cent) 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 per cent) leading to serious harm.

A detailed review of the 128 incidents associated with serious harm revealed that, in 112 reports (87.8 per cent), better compliance with previously issued NPSA guidance would have helped prevent these incidents. The review of these same incidents determined that 125 of these incidents (97.7 per cent) should have been referred to the AO.

A surprising finding was that referral to the AO was only mentioned in one report (0.8 per cent).

Of the full dataset, 301 reports (0.4 per cent) included reference to the “Accountable Officer” or “AO”. Only 32 incidents (10.6 per cent) that had been referred to AOs had caused harm. Most incidents that were referred to AOs concerned breaches of safe custody and documentation procedures, with only 3.0 per cent of incidents involving the safe clinical use of CDs.

Results from qualitative analysis of the incidents that did include mention of the AO support the findings that the focus of the current role of AO is on safe custody and documentation, rather than on reports and learning arising from the clinical use of a CD where a patient has been killed or harmed.

From the total 72,028 incidents, only 2,558 reports (3.5 per cent) were from community pharmacy and general (medical) practices.


Assumptions and limitations of this study are described in the full paper on PJ Online (see “About this paper”). There are several implications for practice:

  • 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. In particular all practitioners who prescribe, dispense or administer CDs should  routinely confirm the intended dose is safe for the patient; for example any new dose of diamorphine or morphine more than 50 per cent higher than the previous dose should be queried.
  • In our opinion prioritising efforts on safe custody and documentation of CDs may distract from ensuring the safe use of these potent medicines.
  • Improvements are required to ensure more reporting of and learning from CD incidents in primary care.
  • The role of the AO for CDs should prioritise reporting of and learning from incidents that have caused serious harm.
  • We recommend an annual report be produced by individual AOs that summarises serious harms that have arisen from the use of CDs and the actions that have been taken to make the systems of use safer to minimise these risks in the future. The report should also include a review of the use of antidotes naloxone and flumazenil.
  • A clinical subgroup to promote safer clinical use of CDs has been established to report to the National Care Quality Commission Accountable Officers for Controlled Drugs Group.

About this paper

The full paper together with references is available on PJ Online at

Correspondence to: David Cousins (email

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11132045

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