Department of Health
Central Government
Noted
The Department of Health outlines existing regulations and guidance regarding controlled drugs, referencing the Shipman Inquiry, the Controlled Drugs Regulations 2006, NICE guidelines and CQC guidance; the Department suggests taking up the concern about Greater Manchester Police's actions with the Home Secretary. (AI summary)
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From the Baroness Blackwood Department Parliamentary Under Secretary of Stale (Lords) of Health Department of Health 39 Victoria Street London SWIH OEU Tel: 020 7210 4850 Your Ref: 8223/CH Ref: PFD-161533 2 FEB 2019 Ms Alison Mutch OBE HM Senior Coroner; Manchester South HM Coroner's Court Mount Tabor Street Stockport SKI 3AG 'Jw Ms Mukzh _ Thank you for your correspondence of 28 December to Matt Hancock about the death of Mrs Joan Wright: Lam replying as Minister with portfolio responsibility for medicines. Firstly, [ would like to say how sorry I was to read of the circumstances of Mrs Wright's death If you have the opportunity to do S0, please pass my condolences to her family. Ihave noted carefully the matters of concern in your report relating to the management of controlled You mention the Shipman Inquiry in your report In response to the Shipman Inquiry's Fourth Report' , there have been significant changes in the governance arrangements for the use and management of controlled The Home Office put in place tighter controls through Regulations covering prescribing, record keeping and safe custody of controlled drugs, and the then http: wwwnicpldorg/neslassets/AthShipmanreport pdf Our drugs. drugs.
Department of Health, implemented The Controlled Drugs (Supervision of Management and Use) Regulations 2006 (the 2006 Controlled Drugs Regulations) (as amended)?. These Regulations mandated health care organisations to put in place standard operating procedures on the prescribing, supply and administration of controlled and the clinical monitoring of patients. The 2006 Controlled Drugs Regulations also require the appointment of a Controlled Accountable Officer (CDAO): This Officer has statutory responsibility for the safe management and use of controlled drugs within their organisation . These Officers are required to work with healthcare providers, regulators and enforcement authorities, including Controlled Liaison Officers (CDLOs), through local intelligence networks (CD LINS) to share any concerns about the use and management of controlled drugs. The 2006 Controlled Regulations were replaced by the current version of the Regulations in April 20133. This replacement was largely due to the approval of the Health and Social Care Act 2012 by Parliament, which led to the removal of primary care trusts (PCTs) and therefore required the responsibilities and powers of PCT CDAOs to be transferred to the then-new NHS Commissioning Board (now NHS England). Under the 2013 Regulations; clinical commissioning groups are not *designated bodies' but are named as 'responsible bodies The responsibilities of 'responsible bodies are set out in the Regulations. NHS England Area Teams are responsible for the appointment of a lead Controlled Drugs Accountable Officer to ensure that systems are in place for the safe and effective management and use of controlled and that these systems are working effectively in their A statutory post-implementation review ofthe revised 2013 Regulations will be undertaken and published before 31 March 2020. [ hope this information is helpful and provides assurance that the Regulations will be reviewed to ensure their continued effectiveness: More generally, the NHS has taken important steps towards improving the safety of medication: http' / www legislation Eov_ukluksi/2006/3 148 /contentslmade https: I www legislation gov ukluksi/2013/373 contentslmade drugs Drug Drug Drug drugs region.
Department of Health The chief pharmacist role; following the report Pharmacy in England (2008)4, was identified as the organisational lead for medicines safety, and a Patient Safety Alert in 2014 required all organisations to identify the role of Medicines Safety Officer to coordinate local medicines safety processes and work collaboratively nationally. NHS Improvement and the Medicines and Healthcare Products Regulatory Agency (MHRA) jointly support a network of Medication Safety Officers and Medical Device Safety Officers. In addition, as part of the Government's response to the World Health Organisation's patient safety challenge on medicines we are developing a programme of work led by NHS Improvement to improve medicines safety. Work is underway to accelerate the roll-out of electronic prescribing to controlled and medicines administration; and to deploy more clinical pharmacists in primary care and care homes. We have also introduced monitoring of the highest risk prescribing practice linked to hospital admissions Furthermore, in response to the Gosport Inquirys , NHS England has initiated the following actions: A review of the governance and leadership of the Controlled Accountable Officer role in NHS England; A review of the operation of the lead Controlled Drug Accountable Officers in NHS England, including the effectiveness of Local Intelligence Networks; and An assurance process to assess how 'designated bodies' (which include NHS trusts and foundation trusts) are reflecting - on the learning from the https Iwww gov uklgovementlpublications/pharmacy-in-cnglnd-building-on-Strcngths-delivering-the_ future btps Iwww gosportpanek independenLgov uklmedin/documents/070618_CCS207_CCS03483220761_Gosport Inquiry_Whole_Documentpdf safety, drugs Drug
Gosport Panel report and reviewing arrangements in their organisation in the light ofit: More broadly, system governance is provided by the Care Quality Commission (CQC), which ensures that health and adult social care providers maintain a safe environment for the management of controlled drugs in England. The CQC reports its findings through individual local inspection reports and by means of published annual updates to Government. It is clearly of great concern that the maladministration of a controlled to Mrs Wright occurred at a time when the care home was monitored by the local authority: It is the registered provider and the registered manager '$ responsibility to ensure the proper and safe management of medicines and guidance is available to support them to achieve this. The National Institute for Health and Care Excellence (NICE) has produced a national guideline on the :Safe use and management of controlled drugs '(NG46)6 , published in 2016,and a social care guideline (SCI) published in 2014,provides guidance on `Managing medicines in care homes Furthermore, the CQC has clear guidance on its website on Storing controlled in care homes'8. Inote your comment about the definition of 'regular' . Iam advised that guidance with regard to checking stocks is given within the NICE guidance NG46. This makes clear that providers should develop a controlled drugs policy and standard operating procedures for storing, transporting, destroying and disposing controlled drugs Detailed guidance is provided on process and procedures storage, stock checks and audits, including on the frequency of stock checks. While no system can ever completely prevent the mismanagement or misuse of controlled we believe the measures that have been in place mean that the inappropriate use of opioids and other controlled drugs can be detected more quickly and minimised, so that protracted pOOr practice is less likely to continue unchecked. hltps: // www nice.org uklguidancelng46 https:Lwww nice Og uklguidance scL https LLwww cgc org uklguidance-providersladult-social carelstorngcontrolled drugs care homes drug being drugs for drugs, put
Department of Health Your report raises concerns about the actions of Greater Manchester Police in responding to the potential safeguarding risks following the incident report of maladministration of Oramorph to Mrs Wright; and questions if learning from this incident has been shared at a national level: The Health Act 2006 placed a greater emphasis on Controlled Drugs Liaison Officers involved in not only the investigation of offences concerning controlled drugs in the health service, but also intelligence and partnership working; particularly through CD-LINs. As CDLOs are employees of the police force, I would suggest taking up this point with the Home Secretary, the Right Honourable Sajid Javid. ~s Nifh NICOLA BLACKWOOD being Sva--1
Department of Health, implemented The Controlled Drugs (Supervision of Management and Use) Regulations 2006 (the 2006 Controlled Drugs Regulations) (as amended)?. These Regulations mandated health care organisations to put in place standard operating procedures on the prescribing, supply and administration of controlled and the clinical monitoring of patients. The 2006 Controlled Drugs Regulations also require the appointment of a Controlled Accountable Officer (CDAO): This Officer has statutory responsibility for the safe management and use of controlled drugs within their organisation . These Officers are required to work with healthcare providers, regulators and enforcement authorities, including Controlled Liaison Officers (CDLOs), through local intelligence networks (CD LINS) to share any concerns about the use and management of controlled drugs. The 2006 Controlled Regulations were replaced by the current version of the Regulations in April 20133. This replacement was largely due to the approval of the Health and Social Care Act 2012 by Parliament, which led to the removal of primary care trusts (PCTs) and therefore required the responsibilities and powers of PCT CDAOs to be transferred to the then-new NHS Commissioning Board (now NHS England). Under the 2013 Regulations; clinical commissioning groups are not *designated bodies' but are named as 'responsible bodies The responsibilities of 'responsible bodies are set out in the Regulations. NHS England Area Teams are responsible for the appointment of a lead Controlled Drugs Accountable Officer to ensure that systems are in place for the safe and effective management and use of controlled and that these systems are working effectively in their A statutory post-implementation review ofthe revised 2013 Regulations will be undertaken and published before 31 March 2020. [ hope this information is helpful and provides assurance that the Regulations will be reviewed to ensure their continued effectiveness: More generally, the NHS has taken important steps towards improving the safety of medication: http' / www legislation Eov_ukluksi/2006/3 148 /contentslmade https: I www legislation gov ukluksi/2013/373 contentslmade drugs Drug Drug Drug drugs region.
Department of Health The chief pharmacist role; following the report Pharmacy in England (2008)4, was identified as the organisational lead for medicines safety, and a Patient Safety Alert in 2014 required all organisations to identify the role of Medicines Safety Officer to coordinate local medicines safety processes and work collaboratively nationally. NHS Improvement and the Medicines and Healthcare Products Regulatory Agency (MHRA) jointly support a network of Medication Safety Officers and Medical Device Safety Officers. In addition, as part of the Government's response to the World Health Organisation's patient safety challenge on medicines we are developing a programme of work led by NHS Improvement to improve medicines safety. Work is underway to accelerate the roll-out of electronic prescribing to controlled and medicines administration; and to deploy more clinical pharmacists in primary care and care homes. We have also introduced monitoring of the highest risk prescribing practice linked to hospital admissions Furthermore, in response to the Gosport Inquirys , NHS England has initiated the following actions: A review of the governance and leadership of the Controlled Accountable Officer role in NHS England; A review of the operation of the lead Controlled Drug Accountable Officers in NHS England, including the effectiveness of Local Intelligence Networks; and An assurance process to assess how 'designated bodies' (which include NHS trusts and foundation trusts) are reflecting - on the learning from the https Iwww gov uklgovementlpublications/pharmacy-in-cnglnd-building-on-Strcngths-delivering-the_ future btps Iwww gosportpanek independenLgov uklmedin/documents/070618_CCS207_CCS03483220761_Gosport Inquiry_Whole_Documentpdf safety, drugs Drug
Gosport Panel report and reviewing arrangements in their organisation in the light ofit: More broadly, system governance is provided by the Care Quality Commission (CQC), which ensures that health and adult social care providers maintain a safe environment for the management of controlled drugs in England. The CQC reports its findings through individual local inspection reports and by means of published annual updates to Government. It is clearly of great concern that the maladministration of a controlled to Mrs Wright occurred at a time when the care home was monitored by the local authority: It is the registered provider and the registered manager '$ responsibility to ensure the proper and safe management of medicines and guidance is available to support them to achieve this. The National Institute for Health and Care Excellence (NICE) has produced a national guideline on the :Safe use and management of controlled drugs '(NG46)6 , published in 2016,and a social care guideline (SCI) published in 2014,provides guidance on `Managing medicines in care homes Furthermore, the CQC has clear guidance on its website on Storing controlled in care homes'8. Inote your comment about the definition of 'regular' . Iam advised that guidance with regard to checking stocks is given within the NICE guidance NG46. This makes clear that providers should develop a controlled drugs policy and standard operating procedures for storing, transporting, destroying and disposing controlled drugs Detailed guidance is provided on process and procedures storage, stock checks and audits, including on the frequency of stock checks. While no system can ever completely prevent the mismanagement or misuse of controlled we believe the measures that have been in place mean that the inappropriate use of opioids and other controlled drugs can be detected more quickly and minimised, so that protracted pOOr practice is less likely to continue unchecked. hltps: // www nice.org uklguidancelng46 https:Lwww nice Og uklguidance scL https LLwww cgc org uklguidance-providersladult-social carelstorngcontrolled drugs care homes drug being drugs for drugs, put
Department of Health Your report raises concerns about the actions of Greater Manchester Police in responding to the potential safeguarding risks following the incident report of maladministration of Oramorph to Mrs Wright; and questions if learning from this incident has been shared at a national level: The Health Act 2006 placed a greater emphasis on Controlled Drugs Liaison Officers involved in not only the investigation of offences concerning controlled drugs in the health service, but also intelligence and partnership working; particularly through CD-LINs. As CDLOs are employees of the police force, I would suggest taking up this point with the Home Secretary, the Right Honourable Sajid Javid. ~s Nifh NICOLA BLACKWOOD being Sva--1