Recurring concern

Unreliable controlled-drug custody, documentation and audit controls

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First reported 13 Oct 2017•Latest report 25 Feb 2020

Definition

What this concern includes

Includes failures in controlled-drug administration records, custody documentation, chain-of-custody rules, stock reconciliation, double-checked audits and reporting of schedule-specific discrepancies.

Not included

  • Excludes clinical monitoring of patients after controlled-drug administration where custody, documentation or audit controls are reliable.
  • Excludes prescribing or dose-selection failures unrelated to controlled-drug accountability.
  • Excludes medicines not subject to controlled-drug custody and audit requirements.
Reports
4

Distinct published reports

Individual concerns
8

A report can raise multiple concerns

Date range
2017–2020

First to latest report issue date

Stated actions
3

Described in published responses

Reports over time

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Most frequent recipients

Reports about this concern sent to each recipient.

Care Quality Commission2
General Pharmaceutical Council2
NHS England2
Boots UK Limited1
General Practitioners Committee UK1
Manchester University NHS Foundation Trust1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

  1. Manchester South

    AI-generated summary

    Elaine Rose Renshaw · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Elaine Rose Renshaw was found unresponsive at home, resuscitated and taken to Tameside General Hospital, where she died on 8 July 2019 after attempts to reverse the effects of morphine were unsuccessful. The inquest identified inaccurate controlled-drug checks and accounting, with concern that the absence of a clear process for recording controlled-drug use could lead to similar problems in other care and nursing homes.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure of controlled drug checks to identify unaccounted drugs

    Wider context from the report

    “During the course of the inquest evidence was given that controlled drug checks processes had been such that it was not easily identified that drugs were not accounted for e.g. Stock sheets were inaccurate. The home in question had tightened up its processes since the incident. However the inquest heard that this issue may well arise in the future in other care/nursing home settings as there is no clear process for handling/recording the use of controlled drugs. ”

    Source location

    Elaine Rose Renshaw · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of a clear process for handling and recording controlled drug use

    Wider context from the report

    “During the course of the inquest evidence was given that controlled drug checks processes had been such that it was not easily identified that drugs were not accounted for e.g. Stock sheets were inaccurate. The home in question had tightened up its processes since the incident. However the inquest heard that this issue may well arise in the future in other care/nursing home settings as there is no clear process for handling/recording the use of controlled drugs. ”

    Source location

    Elaine Rose Renshaw · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report
  2. London Inner (West)

    AI-generated summary

    Michael Lobban · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Michael Lobban, who had drug dependency and mental illness, was found dead at home on 23 October 2017 with a significant methadone overdose and other drugs in his body. The report raised concerns about the speed and completeness of Boots’ investigation into missing methadone, the robustness of its controlled-drug audit procedures, and the General Pharmaceutical Council’s reporting and investigative arrangements for discrepancies in controlled drugs.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of physical checking of prescription-box contents during controlled-drug audits

    Wider context from the report

    “3. There appears to be no physical check of the contents of prescription boxes when carrying out the audit of schedule 2 controlled drugs. ”

    Source location

    Michael Lobban · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of double-checking in controlled-drug audits

    Wider context from the report

    “2. The audit checking of controlled drugs by The Boots Company PLC is not robust in that there is no double check in place in relation to the audit checking procedure followed by Boots. ”

    Source location

    Michael Lobban · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of pharmacy reporting requirements for schedule 2 controlled-drug discrepancies

    Wider context from the report

    “4. The General Pharmaceutical Council (“The Council”) being the Regulator of Pharmaceutical industry in England and Wales does not have any reporting requirements for pharmacies when discovering a discrepancy in schedule 2 controlled drugs. Moreover there appear to be no investigative powers by The Council where it discovers a disparity of these controlled drugs and as a consequence there are no sanctions in circumstances where pharmacies have mislaid drugs during the course of their handling of controlled drugs. ”

    Source location

    Michael Lobban · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report
  3. Manchester City

    AI-generated summary

    Stephen George Coulson · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Stephen George Coulson was discharged from Manchester Royal Infirmary after an increased Fentanyl patch was applied, with no record that the previous patch had been removed and despite confusion and agitation requiring further observation under hospital policy. He was found in cardiac arrest at home in the early hours of 1 January 2016 and died in intensive care later that day. The principal concerns were controlled-drug administration and documentation, failure to escalate the need for observation and review before discharge, and the Trust’s investigation failing to identify lessons.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure of the system for audit of controlled-drug processes

    Wider context from the report

    “1) Controlled drugs – the system in place for the administration, documentation and audit of processes associated with the use of controlled drugs ”

    Source location

    Stephen George Coulson · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure of the system for documentation of controlled drugs

    Wider context from the report

    “1) Controlled drugs – the system in place for the administration, documentation and audit of processes associated with the use of controlled drugs ”

    Source location

    Stephen George Coulson · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Review the Trust’s controlled drugs policy and share proposed improvements with the Trust.

    Verbatim wording from the response

    “As you are aware, the Trust have a controlled drugs policy in place. The pharmacy team within the Commission has reviewed this policy. The policy is of an acceptable standard, with some suggestions for improvements, such as making it clear who has responsibility for investigating medicines incidents, which occur outside of pharmacy. We will share these with the trust.”

    Source location

    2017-0307-Response-by-CQC
    Page 2 · response
    Published 28 November 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Monitor the Trust’s audit of opioid patch monitoring form implementation through quarterly engagement and consider it at the next inspection.

    Verbatim wording from the response

    “The policy was updated in November 2017 to include reference to an opioid patch monitoring form. The use of the form should minimise the risk of a similar incident experienced by Mr Coulson being repeated. The trust managers have informed the Commission that they plan to audit implementation of the form. We will monitor this through our quarterly engagement meetings and subsequently consider this at the next inspection, which is likely to take place between October and December 2018.”

    Source location

    2017-0307-Response-by-CQC
    Page 2 · response
    Published 28 November 2017

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Review the Trust’s controlled drug standard operating procedures through ongoing engagement.

    Verbatim wording from the response

    “The trust must also have in place a controlled drug Standard Operating Procedures (SOPs). We will review these as part of our ongoing engagement with the trust. For your information, we have recently implemented a system of having a named pharmacist inspector who has responsibility for the Trust and who meets with the head pharmacist. They are aware of this Regulation 28 report and will include this as part of their next meeting.”

    Source location

    2017-0307-Response-by-CQC
    Page 2 · response
    Published 28 November 2017

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The controlled drugs policy is of an acceptable standard, although improvements to incident-investigation responsibilities have been suggested.

    Verbatim wording from the response

    “As you are aware, the Trust have a controlled drugs policy in place. The pharmacy team within the Commission has reviewed this policy. The policy is of an acceptable standard, with some suggestions for improvements, such as making it clear who has responsibility for investigating medicines incidents, which occur outside of pharmacy. We will share these with the trust.”

    Source location

    2017-0307-Response-by-CQC
    Page 2 · response
    Published 28 November 2017

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The information currently held provides no evidence that the concerns reflect a systemic issue.

    Verbatim wording from the response

    “In addition, in light of the Regulation 28 report, we have also considered whether there is sufficient evidence to take further regulatory action regarding this matter. We have concluded, based on the information we currently hold, that there is no evidence there is a systemic issue. However, please be assured we will continue to monitor the issues you have raised from a regulatory perspective and use the information to inform future regulatory activity at the Trust.”

    Source location

    2017-0307-Response-by-CQC
    Page 3 · response
    Published 28 November 2017

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    No further regulatory action is considered necessary regarding this matter based on the information currently held.

    Verbatim wording from the response

    “In addition, in light of the Regulation 28 report, we have also considered whether there is sufficient evidence to take further regulatory action regarding this matter. We have concluded, based on the information we currently hold, that there is no evidence there is a systemic issue. However, please be assured we will continue to monitor the issues you have raised from a regulatory perspective and use the information to inform future regulatory activity at the Trust.”

    Source location

    2017-0307-Response-by-CQC
    Page 3 · response
    Published 28 November 2017

    Open published response
  4. Manchester North

    AI-generated summary

    Ms Christina Ann Fletcher · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Ms Christina Ann Fletcher was found dead at home after Zomorph, an opiate and controlled drug, was mistakenly delivered to her on 4 August 2016 and the error went undetected. Post-mortem examination found markedly elevated free morphine, which was attributed directly to the cause of death. Concerns were raised about the absence of specific regulatory guidance on pharmacy red-flag systems for similar names and addresses, and on the chain of custody for controlled drugs.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of specific guidance defining when, where and how the chain of custody for controlled drugs is completed

    Wider context from the report

    “2. Again, there is no specific guidance, policy or protocol from the Regulator (or indeed legal definition) as to when, where and how the chain of custody (for Controlled Drugs) is completed. It currently appears to be a matter of local practice with some Pharmacies make an entry into the CD Register at the point the CD is handed to the delivery driver, with others making an entry once delivery has been confirmed. ”

    Source location

    Ms Christina Ann Fletcher · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The Home Office is best placed to provide information about controlled drug legislation and chain of custody.

    Verbatim wording from the response

    “Whilst we produce guidance and advice of our standards, we do not produce detailed advice on the law. However, the Royal Pharmaceutical Society (RPS) (www.rpharms.com) is the professional body for pharmacists in Great Britain and has produced guidance on the delivery and posting (including abroad) of medicines to patients and maintains practice guidance on the management of controlled drugs. For further information about the chain of custody for Controlled Drugs the Home Office, as the body responsible for controlled drug legislation, is best placed to provide you with this information.”

    Source location

    Christina-Fletcher_Redacted
    Page 4 · response
    Published 27 November 2017

    Open published response
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Data last updated 7 September 2026