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«July 2015 The Care Quality Commission The Care Quality Commission is the independent regulator of health care and adult social care services in ...»

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The safer management

of controlled drugs

Annual report 2014

July 2015

The Care Quality Commission

The Care Quality Commission is the independent regulator

of health care and adult social care services in England.

Our purpose

We make sure health and social care services provide people with safe,

effective, compassionate, high-quality care and we encourage care

services to improve.

Our role

We monitor, inspect and regulate services to make sure they meet

fundamental standards of quality and safety and we publish what we find, including performance ratings to help people choose care.

We also have a statutory duty to oversee the safe management arrangements for controlled drugs in England.

Our values

• Excellence - being a high performing organisation.

Caring - treating everyone with dignity and respect.

Integrity - doing the right thing.

Teamwork - learning from each other to be the best we can.

Care Quality Commission The safer management of controlled drugs: Annual report 2014 Contents Foreword

Summary and recommendations

Progress on recommendations made in the 2013 report

Care Quality Commission activity

CQC’s website

Register of controlled drug accountable officers (CDAOs)

Arrangements with NHS England and controlled drug local intelligence networks.... 13 Examples of good practice from CD LINs

Occurrence reporting

National Group on Controlled Drugs

Clinical subgroup

Cross-Border Group

National trends in the use and management of controlled drugs

Prescribing of controlled drugs in primary care

Schedule 1 controlled drugs

Schedule 2 and 3 controlled drugs

Schedule 4 controlled drugs

Schedule 5 controlled drugs

Nurse and pharmacist prescribing

Private prescribing of controlled drugs

Controlled drugs requisitions

Next steps

Appendix A: Legislation and regulations

Home Office controlled drugs legislation: The Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001

Safer management of controlled drugs

Appendix C: Further information

Glossary of terms

Care Quality Commission The safer management of controlled drugs: Annual report 2014 Foreword This eighth annual report provides a national picture on the regulation of controlled drugs in England. The Care Quality Commission has a responsibility to make sure that health and social care providers, and other regulators, maintain a safe environment for the management of controlled drugs. Our priority is to protect people from unsafe care and we take this responsibility seriously. This is why our Controlled Drugs team and Medicines Management Team have worked constantly to fulfil our organisational role under the controlled drugs regulations, as well as supporting CQC’s wider inspections under the Health and Social Care Act.

It is vital that we have a governance system that can pick up concerns about the misuse of controlled drugs, but at the same time can ensure that health and care staff have proper access to them when needed for people’s clinical care.

The current regulations and governance arrangements for controlled drugs were implemented in response to the Shipman Inquiry to support professionals and encourage good practice around management and use. The regulations have created strengthened cooperation between health and social care providers and the organisations that regulate them. But in the last eight years we have seen diminishing resources, changes to the structure of the NHS, and ever-broadening complexities of the therapeutic use - and misuse - of controlled drugs. This provides continual challenges for healthcare professionals in the safe management and use of controlled drugs.

To respond to these challenges Care Quality Commission has made recommendations - both for ourselves and for other organisations - to make sure that we keep on working collaboratively and that the arrangements for controlled drugs in England continue to keep people safe.

Professor Steve Field CBE FRCP FFPHM FRCGP Chief Inspector of General Practice responsible for Primary Medical Services and Integrated Care Care Quality Commission The safer management of controlled drugs: Annual report 2014 Summary and recommendations As well as regulating health and care services under the Health and Social Care Act 2008, the Care Quality Commission (CQC) is responsible for making sure that health and social care providers, and other regulators, maintain a safe environment for the management of controlled drugs in England. This was in response to the findings of the Fourth report of the Shipman Inquiry and the Government's response to the inquiry's recommendations.

The Controlled Drugs (Supervision of Management and Use) Regulations 2013 came into force on 1 April 2013. This report looks at the work of CQC and other responsible organisations during 2014 under these regulations to ensure safe arrangements for controlled drugs. It also reports on prescribing data for 2014 on controlled drugs across England and identifies any trends in prescribing.

One of CQC’s responsibilities around controlled drugs is to maintain and update the register of controlled drug accountable officers (CDAOs), who are responsible for all controlled drug handling and governance issues in their organisation. Some small organisations are exempt from the need to have a CDAO, but uptake of this exemption during 2014 was low. Another responsibility for CQC is the need to work with local controlled drug intelligence networks (CD LINs) across England, and to work with lead CDAOs to identify organisations that do not engage with their CD LIN and do not provide occurrence reports. We continued to identify and follow up where a CDAO had left an organisation but where we had not received a new notification for the replacement CDAO.

CQC coordinates the National Group on Controlled Drugs, which met four times during

2014. The Clinical Sub Group met twice and the methadone newsletter was published on CQC’s website. We also met twice with our cross border colleagues in Wales, Scotland, Northern Ireland, Republic of Ireland, the Channel Islands and the Isle of Man, to share good practice and discuss controlled drugs-related issues.

CQC has created self-assessment tools to enable primary and secondary care organisations to establish areas of strength or weakness in their controlled drug governance arrangements. We updated these in 2014, to use a more user-friendly red, amber, green (RAG) rating.

This was the first full year under the 2013 Regulations and the new arrangements as set out in the NHS England Single Operating Model (SOM), which provides a framework, guidance and templates for lead CDAOs on their roles and responsibilities. There were 27 NHS England area teams in 2014, but after an organisational capacity review of NHS England in the latter part of the year, some areas amalgamated to form 13 new regions from April 2015.

Care Quality Commission The safer management of controlled drugs: Annual report 2014 Although this has caused some concern in terms of the size of the regions that each NHS England lead CDAO is required to cover, it also provides an opportunity for better collaboration between lead CDAOs and a more joined up approach to sharing good practice. Despite some variation during 2014 in how the area teams fulfilled their functions, CD LIN meetings and learning events were held across all area teams and concerns were shared and followed up. However, in general, there continued to be only minimal engagement with social care organisations and a lack of capacity to monitor controlled drug prescribing.

Discussions continued during 2014 on the feasibility of a national roll-out of the Greater Manchester Area Team (GMAT) reporting tool across England. Consequently, the joint work between CQC and NHS England to collect national occurrence reporting data has been suspended until those discussions are concluded. We will then review how best to gather the national picture.

National trends in the use and management of controlled drugs

In 2014, the total number of controlled drugs items prescribed in NHS primary care was 60,871,306, which is an increase of 0.67% compared with 2013. The cost of this was £548,634,970, representing a decrease of 0.37% compared with £550,684,964 in

2013. Prescribing of all Schedules (2, 3, 4 and 5) of controlled drugs in 2014 stayed broadly similar to that in 2013.

There were a number of legislation changes in June 2014, which included the scheduling of tramadol from a prescription only medicine (PoM) to a Schedule 3 controlled drug;

zopiclone and zaleplon were also scheduled under Part 1 of Schedule 4 alongside zolpidem following control; and lisdexamfetamine was scheduled as a Schedule 2 controlled drug alongside dexamfetamine. In addition, the N-benzylated phenethylamines (NBOMe) and benzofuran compounds (advertised for sale as ‘legal highs’) were listed in Schedule 1 to the 2001 Regulations and designated as drugs to which section 7(4) of the 1971 Act applies as they have no known legitimate uses outside of research. This means they can only be possessed or supplied under a Home Office licence for research of other special purpose.

Prescribing by nurses increased by 12% and prescribing by pharmacists increased by 56% in 2014 compared with 2013. However, this still represents only a small proportion of total controlled drug prescribing. Nurses and pharmacists are principally involved in prescribing methadone and buprenorphine for the treatment of addiction, which accounts for the majority of prescriptions for controlled drugs from these two groups.

Private prescribing accounts for a small proportion of overall controlled drug prescribing (about 0.06%). The total number of Schedule 2 and 3 controlled drug items prescribed privately in 2014 was 38,913, which is an increase of about 5% compared with 2013.

The overall pattern of private prescribing was similar to that reported in 2013.

Care Quality Commission The safer management of controlled drugs: Annual report 2014 Practitioners working in healthcare settings in the community who wish to obtain a stock of a Schedule 2 or 3 controlled drug from a community pharmacy should use a standard Controlled Drug Requisition Form (FP10 CDF). However, use of these forms will not be mandatory until 30 November 2015 and pharmacies can supply controlled drugs requisitioned on non-standard forms. This makes the capturing and analysis of the data more difficult. However, the requisition data that we do have shows that 19,323 controlled drug items were requisitioned in 2014, which is only a small increase of 1% compared with 2013.

2014 was a settling down period in which NHS England lead CDAOs worked hard to ensure that the arrangements for the safe management of controlled drugs were maintained following the restructure of the NHS and changes in regulations during 2013.

Going forward, the further restructure of NHS England must be seen as an opportunity for greater collaboration and consistency across England.

We therefore make the following recommendations.

Care Quality Commission The safer management of controlled drugs: Annual report 2014 Recommendations Recommendation for CQC

• CQC should make information available to small organisations to advise them of the exemption provision in the regulations for the need to appoint a controlled drug accountable officer.

Recommendations for NHS England lead controlled drug accountable officers

• NHS England lead controlled drug accountable officers should use the changes to the regional structure from April 2015 as an opportunity to work more collaboratively so that there is greater national consistency of approach to delivering their controlled drug responsibilities.

• NHS England lead controlled drug accountable officers should engage with and formalise the support of clinical commissioning groups (CCGs) so that monitoring controlled drug prescription activity is a higher priority.

• NHS England lead controlled drug accountable officers should determine how best to engage with social care organisations in their area and should encourage local authorities to be engaged in controlled drug local intelligence networks (CD LINs).

Recommendations for NHS England

• NHS England should provide guidance for occurrence reporting so that organisations understand what they need to report to the CD LIN.

Recommendation for all controlled drug accountable officers

• Controlled drug accountable officers should share organisational learning from controlled drug-related incidents with their CD LINs and, where possible, develop links with their Medication Safety Officers (MSOs) to maximise these opportunities for learning.

Care Quality Commission The safer management of controlled drugs: Annual report 2014 Progress on recommendations made in the 2013 report In the report for 2013, CQC made seven recommendations to improve the management of controlled drugs. In this section, we report on the progress made against these.

Recommendation 1 NHS England controlled drug accountable officers must be adequately resourced to carry out their roles and responsibilities with regard to controlled drugs.


During 2014, NHS England controlled drug accountable officers (CDAOs) found a number of ways to carry out their responsibilities. These included secondments, informal arrangements with clinical commissioning groups (CCGs) and commissioning support units (CSUs) and other goodwill gestures. The changes to NHS England in 2015 provide a new opportunity for more collaborative working, which will help achieve greater national consistency as long as capacity is used effectively.

Recommendation 2 NHS England controlled drug accountable officers must be clear about their responsibilities for controlled drug governance arrangements and strengthen their relationships with CCGs and CSUs so that these organisations are clear as to how they can support them.


Although CCGs and CSUs provided some support, there was a mixed picture. The arrangements for how CCGs should support NHS England CDAOs are now clearly set out in the delegation agreement for co-commissioning.

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