safe management and use of controlled drugs
TRANSCRIPT
Scrutiny
July 2014
Safe management and use of controlled drugs
© 2014 Healthcare Improvement ScotlandFirst published July 2014
The contents of this document may be copied or reproduced for use within NHSScotland, or for educational, personal or non-commercial research purposes only. Commercial organisations must obtain written permission from Healthcare Improvement Scotland prior to copying or reproducing any part of this document.
Unless otherwise stated, NHS boards, NHS organisations and other healthcare providers, including independent hospitals, hospices, and the General Medical Council supplied the information contained in this report. It is believed to be reliable on publication.
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Contents
Acknowledgements 4Executive summary 5Setting the scene 8Our findings 10Our conclusions 15
Appendix 1: Evaluation panel members 16Appendix 2: Register of designated bodies 18Appendix 3: The Shipman Inquiry 21Appendix 4: Legislation and guidance 22Appendix 5: Glossary of terms 24
Safe management and use of controlled drugs4
Acknowledgements
We would like to thank all those involved in the first scoping exercise undertaken in Scotland of the governance arrangements in place for the safe management and use of controlled drugs. In particular, thanks to Alison Rees and David Marshall from the Care Inspectorate, Eddie McGinney and Craig McKinlay from Counter Fraud Services and the team from the Care Quality Commission for their advice, support and constructive criticism during the preparation for, and throughout, the baseline scoping exercise.
This co-operation will help make sure that the future approaches we use will be applicable across health and social care in Scotland and are consistent with practice elsewhere in the UK. Others who were involved in the baseline scoping exercise are listed in Appendix 1.
In addition, special thanks to Judie Gajree, NHS Lothian and Anne Taylor, NHS Grampian for piloting the self-assessment and for their constructive feedback.
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Executive summary
Healthcare Improvement Scotland’s work to oversee the safe management and use of controlled drugs involves:
• providing external scrutiny of the governance arrangements organisations have in place for the safe management and use of controlled drugs
• reporting to the public, Scottish Government and healthcare organisations on these arrangements, and
• managing the register of Controlled Drugs Accountable Officers (CDAOs) in Scotland.
Our remit extends to all controlled drugs designated bodies including NHS boards, hospices and independent hospitals.
We also liaise closely with other regulators and scrutiny bodies including the Care Inspectorate and the Care Quality Commission to make sure we have a consistent, informed and risk-based approach to the safe management and use of controlled drugs in Scotland which complements the arrangements in place across the rest of the UK.
This is our first report on the governance arrangements for the safe management and use of controlled drugs in Scotland and relates to the year ended 31 December 2013.
In 2013, changes were made to the Regulations governing controlled drugs which gave additional powers to carry out external scrutiny of the controlled drugs governance arrangements in place in Scotland. This brings Scotland into line with the scrutiny and governance arrangements in the rest of the UK.
This report will inform the implementation of the new Regulations in Scotland and future reports will take account of these. This report does not cover the clinical use of controlled drugs which is the subject of ongoing work through the Controlled Drugs Accountable Officers Network (Scotland). The Network initially prioritised setting up the necessary safe systems and processes, and is now focusing on the safe and appropriate clinical use of controlled drugs.
Safe management and use of controlled drugs6
While the revised Regulations introduce mandatory participation in external scrutiny of controlled drugs arrangements from 2013, Scotland has worked hard over the past 6 years on implementing The Controlled Drugs (Supervision of Management and Use) Regulations 2006. During this time, there has been considerable progress in developing the systems and processes for good controlled drugs governance. The introduction of scrutiny is intended to further strengthen this work and the systems already in place. It will also provide a Scotland-wide picture which will identify our priority areas for improvement.
For this baseline scoping exercise, we developed a self-assessment that focuses on the two main provisions within the Regulations:
• the appointment of CDAOs, and
• the sharing and using of information between organisations, regulators and agencies through controlled drugs local intelligence networks.
The Controlled Drugs (Supervision of Management and Use) Regulations 2006 describe the detail of the two provisions above. The revised Regulations, the Controlled Drugs (Supervision of Management and Use) Regulations 2013 came into force on 1 April 2013 and further refine these provisions. A list of relevant legislation is provided at Appendix 4.
As a result of this baseline scoping exercise, we have made the following five recommendations.
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Recommendation
01
Designated bodies must check their entry on the Healthcare Improvement Scotland Controlled Drugs Accountable Officer (CDAO) register at least annually and make sure that this is kept up to date.
Recommendation
02Designated bodies must have cover arrangements for CDAO absence as this is a senior and complex responsibility, particularly in large organisations covering primary, acute and independent healthcare.
Recommendation
03 Designated bodies are required to run or participate in a local intelligence network under the 2013 Regulations. The local intelligence network arrangements for NHS Greater Glasgow and Clyde, NHS Lanarkshire and NHS Ayrshire & Arran must be in place by December 2014. We will review the position at this stage.
Recommendation
04Organisations and local intelligence networks need to make sure key information is shared across governance and healthcare professionals including doctors, nurses and pharmacy teams. The membership of local intelligence networks should include the independent healthcare organisations located within the local NHS board area to meet the duty of co-operation between responsible bodies.
Recommendation
05Designated bodies must report annually from 2014–2015 into the governance structure of their organisation to provide an assurance of their arrangements for controlled drugs. Controlled drugs form a substantial part of healthcare and treatment budgets and have significant patient safety risks associated with them.
Safe management and use of controlled drugs8
Setting the scene
Our purpose
Healthcare Improvement Scotland’s purpose is to support healthcare providers in Scotland to deliver high quality, evidence-based, safe, effective and person-centred care; and to scrutinise those services to provide public assurance about the quality and safety of that care. This applies to NHS and independent healthcare providers.
Healthcare Improvement Scotland’s role in controlled drugs governance
Our role under the controlled drugs Regulations is to provide external assurance that all designated bodies in Scotland have governance arrangements in place for the safe management and use of controlled drugs.
Background
Controlled drugs are widely used in modern healthcare and in a wide variety of clinical treatments. They include drugs such as diamorphine, which can be used for the relief of acute and chronic pain, end-of-life treatments or as part of the treatment of substance misuse.
Controlled drugs have the potential to be misused and cause harm. To prevent them being obtained illegally, they are subject to special legislative controls.
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What we did
This is the first time a formal review has been carried out in Scotland of the governance arrangements organisations have to support the safe management and use of controlled drugs. This baseline scoping exercise was designed to:
• determine the governance arrangements currently in place within each designated body in Scotland, and
• inform the methodology, frequency, and scale of our future scrutiny and assurance activity in this area.
To ensure our approach is risk based and proportionate, we developed a self-assessment that:
• focuses on the strategic level
• assesses the organisational governance arrangements for the safe management and use of controlled drugs, and
• covers the main elements of the 2013 Regulations.
We also took into account the responsibilities held by the CDAOs under the Regulations, the work already carried out by the Controlled Drugs Accountable Officers Network (Scotland) and existing local clinical governance arrangements.
To help us develop the self-assessment, we set up a task and finish group consisting of a range of subject matter experts and key stakeholders. This included individuals with knowledge and experience of the prescribing and dispensing of controlled drugs and those with specific knowledge and responsibility for clinical governance. This expert group also included public partners.
Similarly, our evaluation panels were made up of those with expertise in clinical governance, prescribing and pharmacy as well as our public partners.
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Our findings
All healthcare organisations are responsible for making sure that they have arrangements in place to assure the safe management and use of controlled drugs, and that systems are working effectively. All healthcare professionals also have a duty to make sure that controlled drugs in their own area of practice are managed safely.
The two main provisions for ensuring safe management and use of controlled drugs are the appointment of CDAOs and sharing and using information between organisations, regulators and agencies through controlled drugs local intelligence networks. Healthcare organisations defined as ‘controlled drugs designated bodies’ are required to appoint CDAOs. The CDAO is the person within a controlled drugs designated body who has organisational responsibility for controlled drugs. The responsibilities of the CDAO are set out in detail in the 2006 Regulations. Smaller organisations and those not named in the Regulations as designated bodies are not required to appoint a CDAO. However, this does not alter any of the requirements to comply with the Misuse of Drugs Regulations and to make arrangements for the safe management and use of controlled drugs.
At the time of our review, there were 50 designated bodies on the Healthcare Improvement Scotland register for CDAOs. We contacted all of these organisations and asked them to complete the self-assessment. We also cross checked the CDAO register with the names of the registered independent healthcare organisations. Forty-eight out of the fifty organisations returned a completed self-assessment. One organisation (The Priory Hospital, Glasgow) did not send us its self-assessment within the required timescale. Its information has therefore not been included in this report. The Priory Hospital has been asked to provide us with the required information for assurance purposes. The other organisation (Huntercombe Hospital, Edinburgh) informed us that it does not use controlled drugs. We will follow this up and ask Huntercombe Hospital to formally apply for an exemption from the requirement to nominate a CDAO. The current register of designated bodies is given at Appendix 2.
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Section 1: Organisation
The first part of the self-assessment asks for information about the organisation, details about their current CDAO and their business continuity or CDAO cover arrangements. This section also acts as the organisation’s self-declaration that the information provided within the self-assessment is true and correct at the time of submission. In addition to asking the CDAO to sign the form, we also asked for the chief executive or senior officer to sign off the form. All organisations that returned a self-assessment complied with this. We found that for some of the smaller independent healthcare providers, the CDAO was also either the chief executive or the senior officer of the service which places greater importance on having CDAO cover arrangements in place.
Every designated body in Scotland has appointed a CDAO. In three instances, the details provided did not match the details held on our CDAO register at the time. Although this allowed us to update the register, it remains the responsibility of individual organisations to make sure this information is provided to Healthcare Improvement Scotland.
The arrangements reported to support the CDAO and to make sure the CDAO role and function is covered at all times were variable. Some organisations had formally appointed or nominated a deputy CDAO (27%). A number of organisations made the point that they are not required to appoint a deputy. Some organisations told us they had established a controlled drugs team
(20%) to support the CDAO.
A small number (10%) reported that they had appointed a deputy CDAO and a controlled drugs team. The remaining organisations either did not describe their arrangements or told us that the CDAO was able to seek additional support if required and cover could be identified during periods when the CDAO is absent.
Designated bodies must notify Healthcare Improvement Scotland in writing if their CDAO changes or of any changes to the details of the existing CDAO. This includes interim or temporary CDAO appointments. Guidance on how to do this can be found here on our website.
Designated bodies must check their entry on the Healthcare Improvement Scotland Controlled Drugs Accountable Officer (CDAO) register at least annually and make sure that this is kept up to date.
Designated bodies must have cover arrangements for CDAO absence as this is a senior and complex responsibility, particularly in large organisations covering primary, acute and independent healthcare.
Recommendation
01
Recommendation
02
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Section 2: Sharing information
The second section of the self-assessment covers information sharing through controlled drugs local intelligence networks. It also asks about improvements made in practice as a result of this.
Local intelligence networks provide a forum for organisations, regulators and agencies to raise concerns and share intelligence about organisations or individuals in relation to the safe management and use of controlled drugs. This means that concerns can be shared at the earliest stage with other agencies that may be affected or that may hold additional information. Over the past 6 years much work has been done to establish effective working arrangements that have carried forward the original policy intent. The overall result is that 11 of the 14 (79%) territorial NHS boards reported that they have established a local intelligence network.
We were concerned to learn that the West of Scotland Regional Intelligence Network hosted by NHS Greater Glasgow and Clyde and including NHS Ayrshire & Arran and NHS Lanarkshire was disbanded in 2013. It was reported that this regional network had not included hospices and independent hospitals of which there are several within the geographical areas of these NHS boards. None of the three NHS boards has established a local intelligence network since then, although work is under way to address this. Informal networking is in place, but such a large geographical area with a considerable population does need effective information-sharing arrangements.
Recommendation
03
Designated bodies are required to run or participate in a local intelligence network under the 2013 Regulations. The local intelligence network arrangements for NHS Greater Glasgow and Clyde, NHS Lanarkshire and NHS Ayrshire & Arran must be in place by December 2014. We will review the position at this stage.
Organisations and local intelligence networks need to make sure key information is shared across governance and healthcare professionals including doctors, nurses and pharmacy teams. The membership of local intelligence networks should include the independent healthcare organisations located within the local NHS board area to meet the duty of co-operation between responsible bodies.
Recommendation
04
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Section 3: Monitoring, auditing and reporting
Organisations reported that they are using standard operating procedures, many of which have been developed by the Controlled Drugs Accountable Officer Network (Scotland). They also reported they are auditing and monitoring the management and use of controlled drugs, but few examples were provided.
Much of the activity around awareness raising, training and updating of standard operating procedures was pharmacy focused. To further improve the current arrangements, the panels suggested developing closer working between pharmacy, prescribing and clinical governance. There has been a strong focus on the
CDAO’s role in managing the risks associated with security, record-keeping and unauthorised use of controlled drugs. However, it is important that CDAOs also have regard to managing the risks associated with the clinical use of controlled drugs. The CDAO is empowered through the Regulations to direct services to protect the safety of patients, where the use of controlled drugs is considered unsafe for patients. The panels were interested to note that some CDAOs were involved in patient safety and improvement programmes.
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Section 4: Governance
The fourth section of the self-assessment covers the reporting arrangements and the governance structures used to provide assurance about the safe management and use of controlled drugs. The majority (73%) of organisations responded that they either report to their own Board or to a governance committee, such as the clinical governance committee. The format and frequency of reporting varied, reflecting the size, type and internal governance structures of the organisation.
Designated bodies must report annually from 2014–2015 into the governance structure of their organisation to provide an assurance of their arrangements for controlled drugs. Controlled drugs form a substantial part of healthcare and treatment budgets and have significant patient safety risks associated with them.
Three other issues were brought to our attention in the course of the review.
• The role of Police Scotland in approving controlled drugs storage arrangements Until 2013, local police forces approved these arrangements. The new single police force which came into being in 2013 no longer appears to fulfil this role. Clarity is required on how organisations now obtain approval. This can be taken forward by the Controlled Drugs Accountable Officers Network (Scotland).
• Home Office licence requirements NHS organisations are exempted from having Home Office licences for storing and administering controlled drugs, unless they manufacture controlled drugs for the supply to others. Likewise hospices are not required to hold a Home Office licence. Independent hospitals do require a Home Office licence, but not all had one and some held out-of-date licences. Clarity on this can be taken forward through the Controlled Drugs Accountable Officers Network (Scotland).
• Scottish Government guidance on implementing the 2013 Regulations Legislation and Regulations on controlled drugs are reserved and issued at UK level. The updated Regulations came into force in April 2013 and Scottish Government is developing local guidance. The guidance will apply to health and social care and will state explicitly that care homes are included.
Recommendation
05
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Our conclusions
Our evaluation panels concluded that organisations in Scotland have worked hard to establish local and national governance arrangements for the safe management and use of controlled drugs. All organisations have a CDAO in place and have developed and continue to build on information-sharing arrangements.
Local intelligence networks are functioning effectively in many areas and there was frequent reference to the value of the Controlled Drugs Accountable Officers Network (Scotland) which has worked hard to develop national standard operating procedures and guidance. It has also provided a valued forum for information sharing, learning and improving practice.
All of this provides a strong infrastructure to support continued improvement and CDAOs can now consolidate their focus on managing the risks associated with security, record-keeping and unauthorised use of controlled drugs, as well as the exciting challenge of managing the risks associated with the clinical use of controlled drugs. We would urge all organisations to consider ways of supporting this aspect of the CDAO role.
The other challenge is to strengthen local reporting and to make sure controlled drugs arrangements are visible on the organisation’s governance and assurance agenda.
We will follow up on our recommendations and report on progress in 2015–2016.
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Appendix 1: Evaluation panel members
Tom ByrnePrison Pharmacy AdvisorHealthcare Improvement Scotland
Audra CookClinical Governance Co-ordinatorThe Prince and Princess of Wales Hospice
George FernieSenior Medical ReviewerHealthcare Improvement Scotland
Kevin Freeman-FergusonSenior InspectorHealthcare Improvement Scotland
Judie GajreeLead PharmacistNHS Lothian
Norman GibbPublic Partner
Marjory MackayDirector of NursingStrathcarron Hospice
Gareth MarrSenior InspectorHealthcare Improvement Scotland
David MarshallProfessional Adviser – PharmacyThe Care Inspectorate
Winnie McLureInspectorHealthcare Improvement Scotland
Daniel McQueenPublic Partner
Arlene Napier (Panel chair)Head of Clinical Governance and Risk Management NHS Tayside
Alison ReesProfessional Adviser – PharmacyThe Care Inspectorate
Mark Swatton (Panel chair) Clinical Governance ManagerNational Waiting Times Centre
Liz Tait (Panel chair)Professional Lead for Clinical GovernanceNHS Grampian
Elizabeth ThomasDirector of Clinical ServicesSt Margaret of Scotland Hospice
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Audrey ThompsonLead PharmacistNHS Greater Glasgow and Clyde
Ian ThompsonGeneral PractitionerEast Linton Surgery
Fraser TweediePublic Partner
Alison WilsonDirector of PharmacyNHS Borders
Mike WinterMedical Director, PCF SBUNHS National Services Scotland
Healthcare Improvement Scotland Support
Liz AndersonProject Officer
Jane Byrne Senior Programme Manager
Nanisa FeildenProgramme Manager
Elaine RacionzerProject Officer
Jan WarnerHead of Supporting Good Clinical Practice
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Appendix 2: Register of designated bodies
NHS boards
NHS Ayrshire & Arran
NHS Borders
NHS Dumfries & Galloway
NHS Fife
NHS Forth Valley
NHS Grampian
NHS Greater Glasgow and Clyde
NHS Highland
NHS Lanarkshire
NHS Lothian
NHS National Waiting Times Centre
NHS Orkney
NHS Shetland
NHS Tayside
NHS Western Isles
Scottish Ambulance Service
The State Hospitals Board for Scotland
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Aspen Healthcare Ltd - The Edinburgh Clinic, Edinburgh
BMI Healthcare Ltd - Albyn Hospital Aberdeen
BMI Healthcare Ltd - Carrick Glen Hospital, Ayr
BMI Healthcare Ltd - Fernbrae Hospital, Dundee
BMI Healthcare Ltd - Kings Park Hospital, Stirling
BMI Healthcare Ltd - Ross Hall Hospital, Glasgow
Castle Craig Hospital Ltd – Castle Craig Hospital, West Linton
Nuffield Health Ltd - Nuffield Health Glasgow Hospital
Priory Healthcare Ltd - The Priory Hospital, Glasgow
Quarriers - Scottish Epilepsy Centre, Glasgow
Scuta Ltd T/A - Alexander Clinic, Oldmeldrum
Spire Healthcare Ltd - Shawfield Park Hospital, Edinburgh
Spire Healthcare Ltd - Murrayfield Hospital, Edinburgh
Surehaven Hospital, Glasgow
The Danshell Group - Monroe House, Dundee
The Disabilities Trust - Graham Anderson House, Glasgow
The Huntercombe Group - Huntercombe Hospital, Edinburgh
Independent hospitals
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Accord Hospice, Paisley
Ardgowan Hospice, Greenock
Bethesda Hospice, Stornoway
Children’s Hospice Association Scotland - Robin House, Balloch
Children’s Hospice Association Scotland - Rachel House, Kinross
Highland Hospice, Inverness
Marie Curie Cancer Care - Marie Curie Hospice, Edinburgh
Marie Curie Cancer Care – Marie Curie Hospice, Glasgow
Partnerships in Care Scotland Ltd - The Ayr Hospice, Ayr
Prince and Princess of Wales Hospice, Glasgow
St. Andrew’s Hospice, Airdrie
St. Columba’s Hospice, Edinburgh
St. Margaret’s of Scotland Hospice, Clydebank
St. Vincent’s Hospice, Johnstone
Strathcarron Hospice, Denny
The Ayrshire Hospice, Ayr
Hospices
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Appendix 3: The Shipman Inquiry
The Shipman Inquiry was an independent public inquiry set up in 2001 to examine the issues arising from the case of Harold Shipman. The inquiry’s Fourth Report focused on the methods Shipman used to divert large quantities of controlled drugs for his own purposes, and considered how he was able to do it for so long without being detected. It concluded that there were serious shortcomings in the systems for regulating the governance of controlled drugs. In response, the Controlled Drugs (Supervision of Management and Use) Regulations 2006 were introduced and include provision for the following:
• The appointment of CDAOs in healthcare organisations described as ‘controlled drugs designated bodies’. The accountable officer is responsible for all aspects of the safe and secure management of controlled drugs in the organisation.
• Formal, on-site inspections of providers of health and social care by various bodies.
• The sharing of information, including a legal duty of collaboration among all ‘responsible bodies’, and establishing local intelligence networks.
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Appendix 4: Legislation and guidance
UK wide legislation
The Controlled Drugs (Supervision of Management and Use) Regulations 2013
The Controlled Drugs (Supervision of Management and Use) Regulations 2013
Misuse of Drugs and Misuse of Drugs (Safe Custody) (Amendment) Regulations 2007
The Misuse of Drugs and Misuse of Drugs (Safe Custody) (Amendment) Regulations 2007
The Controlled Drugs (Supervision of Management and Use) Regulations 2006
The Controlled Drugs (Supervision of Management and Use) Regulations 2006
Health Act 2006 Health Act 2006
Misuse of Drugs Regulations (MDRs) 2001
The Misuse of Drugs Regulations 2001
Misuse of Drugs (Supply to Addicts) Regulations 1997
The Misuse of Drugs (Supply to Addicts) Regulations 1997
Misuse of Drugs and Misuse of Drugs (Safe Custody) Regulations 1973
The Misuse of Drugs (Safe Custody) Regulations 1973The Misuse of Drugs Regulations 1973
Misuse of Drugs Act (MDA) 1971 (Home Office)
Misuse of Drugs Act 1971
Medicines Act 1968 Medicines Act 1968
Department of Health guidance and information
Information about the Regulations (including question and answer section)
DoH information and guidance (Controlled Drugs Regulations 2013)
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Scottish Government guidance issued relating to controlled drugs
CEL(2012)35 Licensing arrangements for prescribing, supplying and administering diamorphine, cocaine and dipipanone for the treatment of drug misuse and addiction
CEL(2010)25 Safer management of controlled drugs: Accountable Officers: updated contact details
CEL(2008)07 Safer management of controlled drugs: a guide to good practice in secondary care (Scotland)
CEL(2007)21 Safer management of controlled drugs: A. changes to record keeping requirements; B. destruction of controlled drugs: new role for accountable officers; C. accountable officers: contact details (updated)
CEL(2007)16 Safer management of controlled drugs: private requisition forms for schedules 1, 2 and 3 controlled drugs
CEL(2007)14 Safer management of controlled drugs: standard operating procedures
HDL(2007)12 Safer management of controlled drugs: guidance on strengthened governance arrangements
HDL(2006)27 Safer management of controlled drugs (CDs): private CD prescriptions and changes to NHS prescriptions
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Appendix 5: Glossary of terms
controlled drugs Drugs that are controlled under the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001.
controlled drugs accountable officer (CDAO)
The person in a healthcare organisation who takes formal responsibility for all controlled drugs handling and governance issues in their organisation. This is a requirement under the Health Act 2006. Details of the role are set out in the Controlled Drugs (Supervision of Management and Use) Regulations 2013.
controlled drugs designated body
A healthcare organisation that is required to have an accountable officer under the Controlled Drugs (Supervision of Management and Use) Regulations 2006.
local intelligence network
Defined in legislation as a network to share information between organisations and agencies about the management and use of controlled drugs.
reponsible body An organisation specified in the Controlled Drugs (Supervision of Management and Use) Regulations 2013 that is required to share intelligence and information relating to management and use of controlled drugs.
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