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But more work still needed, says healthcare watchdog

NHS and private healthcare providers have taken positive steps to improve the monitoring and management of controlled drugs following the Shipman Inquiry. But more work is necessary to ensure all concerns are picked up, investigated and, where appropriate, action is taken.

This is the main finding of a Healthcare Commission report published last week.

The report outlines the steps that have been taken to improve monitoring of controlled drugs since the Controlled Drugs (Supervision of Management and Use) Regulations came into force in England on 1 January 2007.

The regulations followed the Government’s response to the fourth Shipman Inquiry report, The Regulation of Controlled Drugs in the Community (July 2004), and provide a new legislative structure for the safer management of drugs that are liable to abuse, including narcotics such as diamorphine.

The regulations gave the Healthcare Commission an overarching responsibility to coordinate this work. They also require the appointment of “accountable officers” within all NHS trusts and private hospitals to be responsible for the safe and secure management of all aspects of controlled drugs within their organisation. This includes monitoring the prescription, storage and administration of controlled drugs and checking that they are not diverted for inappropriate use or financial gain.

The regulations also introduce a new requirement to share information through local intelligence networks.

The report states that, since the regulations came into effect in January 2007:

• Almost all NHS trusts and private hospitals have appointed an accountable officer responsible for monitoring the use of controlled drugs – 1034 accountable officers are in post. The Healthcare Commission will follow up with organisations where an accountable officer is not in post.
• 89 local intelligence networks covering 138 PCTs have been established across England. Network members from across the health and social care community are required to report concerns about any aspect of controlled drugs handling to the group, whose membership includes Healthcare Commission assessors, other regulators and the police. Network members have started to share information to identify concerns.
• Healthcare providers have put better mechanisms in place for the management of controlled drugs, including improved documentation and procedures.
• A national group of regulatory bodies and agencies responsible for differing aspects concerning the use of controlled drugs has been established, set up by the Healthcare Commission.

However more work is needed in some areas to ensure that all concerns are picked up, investigated and, where necessary, acted upon. The Healthcare Commission’s recommendations include the following:

• Local intelligence networks must share information about controlled drug concerns, including concerns related to named individuals. The review found that individuals within the networks are not always confident to share information, including concerns about named healthcare professionals. The Healthcare Commission is working with the networks to ensure they understand how this can be addressed.
• Leadership and lines of accountability should be clearly identified in local intelligence networks that serve more than one primary care trust.
• Healthcare professionals who prescribe or administer drugs to patients within care homes must ensure that the care home has a written record of the drugs prescribed and administered, in addition to their own records. The Commission for Social Care Inspection have reported that this does not happen consistently.
• Doctors, including GPs and private doctors, must write private prescriptions for controlled drugs on the appropriate form in order that the quantity and type of all schedule 2 and 3 controlled drugs being prescribed privately can be monitored. The Royal Pharmaceutical Society of Great Britain report that some prescribers remain unaware of the new requirements and the need to use the standardised form.
• Each NHS chief executive and board needs to know whether the trust is fulfilling its responsibility in relation to controlled drugs, for example by receiving quarterly reports from the accountable officer.

Anna Walker, Chief Executive of the Healthcare Commission, said: “Healthcare services have taken the first steps in minimising the risk of another Shipman. This is important in improving patient safety and it is to be welcomed.

“Much work is still necessary to embed the new networks and ensure that concerns about controlled drugs are picked up, investigated and, where necessary, acted upon. Healthcare managers need to ensure that the networks are working effectively, staff feel able to raise concerns as appropriate and unusual patterns in the use of these drugs are investigated.

“We owe it to Shipman’s victims and their relatives to be vigilant in ensuring that controlled drugs are managed safely and effectively.”

In 2008, the Commission will continue to work with all involved to drive up standards of sharing and reviewing risks, to build on the good start that has already been made with the setting of new mechanisms and systems to do this. It will also monitor the performance of senior management in responsible bodies to ensure that they are engaged and have in place mechanisms to ensure that they can review risks effectively.

The safer management of controlled drugs - Annual report 2007 (pdf 895kb) (opens new window)

Notes to editor:

The Health Act 2006 provided the underpinning legislation for the new arrangements. The details were set out in new regulations The Controlled Drugs (Supervision of Management and Use) Regulations came into force in England on 1 January 2007.

Harold Shipman was convicted in 2000 for the murder of 15 patients, however a public inquest chaired by Dame Janet Smith found that there was enough evidence to suggest that Shipman had killed over 200 people through acquiring large quantities of the controlled drug diamorphine.

Controlled drugs are a group of medicines that have the potential for abuse. For this reason they are “controlled” by Home Office legislation: The Misuse of Drugs Act 1971. The legitimate, clinical use of controlled drugs is further governed by the Misuse of Drugs Regulations 2001. These divide controlled drugs into five schedules according to the level of control they need – drugs in Schedule 1 are rarely used in clinical practice, and Schedules 2 to 5 provide reducing levels of control.

About the Healthcare Commission:
The Healthcare Commission is the health watchdog in England. It keeps check on health services to ensure that they are meeting standards in a range of areas. The Commission also promotes improvements in the quality of healthcare and public health in England through independent, authoritative, patient-centred assessments of those who provide services.

Responsibility for inspection and investigation of NHS bodies and the independent sector in Wales rests with Healthcare Inspectorate Wales (HIW). The Healthcare Commission has certain statutory functions in Wales which include producing an annual report on the state of healthcare in England and Wales, national improvement reviews in England and Wales, and working with HIW to ensure that relevant cross-border issues are managed effectively.

The Healthcare Commission does not cover Scotland as it has its own body, NHS Quality Improvement Scotland. The Regulation and Quality Improvement Authority (RQIA) undertakes regular reviews of the quality of services in Northern Ireland.

For further information, contact Megan Tudehope in the Healthcare Commission press office on 020 7448 9210 or after hours on 07917 232143.