Health Bill

Clause 17 enables regulations to be made so that all NHS healthcare organisations including foundation trusts and larger private sector healthcare organisations, such as independent hospitals, will be required to appoint an ““accountable officer””. That person will ensure the safe management of controlled drugs within their organisation and take action where necessary. The appointment of accountable officers is part of the package of provisions intended to strengthen the governance and accountability arrangements for the safe management of controlled drugs in healthcare settings. It provides the legislative framework to the programme of action set out in Safer management of controlled drugs: the Government’s response to the Fourth report of the Shipman Inquiry. As the noble Earl rightly said, the inquiry recommended the creation of a separate controlled drugs inspectorate to detect and investigate concerns. However, the Government have opted to establish a system of accountable officers, for a number of reasons. It is important to ensure local ownership and to embed safer management of controlled drugs within clinical governance. Local accountable officers will ensure that controlled drugs information can be analysed alongside other clinical governance information. It can then be interpreted in its local context, avoiding a high number of ““false positives””. Those are cases which are seemingly of concern but can be easily explained, such as high rates of controlled drugs prescribing because of the presence of a hospice. Local ownership will also support good practice in the management of controlled drugs and encourage their use for patients for whom they are clinically appropriate. We also want to achieve better regulation. A number of inspectorates already inspect aspects of controlled drugs management. The system of accountable officers will work alongside this, whereas a separate inspectorate might lead to duplication and extra burden on those providing services. The accountable officer will be responsible for all aspects of the safe and effective use and management of controlled drugs, and will have information regarding the requisitioning, storage and destruction of controlled drugs in their organisation and information on the quality and quantity of prescribing and dispensing of those drugs. Where they have concerns, they will be entitled to enter and inspect GP practices in relation to controlled drugs issues. Proposed changes to the misuse of drugs regulations will provide accountable officers with a great deal of information about the prescribing habits of professionals in both their private and NHS practices. The data will be collated nationally and any discrepancies will be highlighted to the accountable officer for follow-up at local level. In NHS primary care, the accountable officer of the primary care trust will be responsible for all its independent contractors—for example, GPs, dentists and out-of-hours service providers. All NHS secondary care providers will be required to appoint an accountable officer. In the private and voluntary sectors, registered managers will remain accountable for the day-to-day management of controlled drugs and the Healthcare Commission and Commission for Social Care Inspection will be responsible, as they are now, for assessing the management of controlled drugs as part of their regular inspections. Larger independent providers, such as private hospitals, will also be required to appoint an accountable officer. Regulations will be made to provide details on which organisations must appoint an accountable officer and the criteria for that appointment. The regulations will also set out the responsibilities of the officer regarding the management of controlled drugs, including storage, carriage and safe custody, prescribing, administration, recovery and disposal of those drugs, and the requirement to follow best practice. The regulations also allow for the creation of offences punishable by a fine and other procedures for enforcing any of the provisions. Although we cannot guarantee that this would prevent another Shipman, we are confident that poor practice would be detected much earlier. The noble Earl mentioned Dame Janet’s other recommendations. We are currently piloting a system of patient drug record cards for injectable Schedule 2 drugs. That is being evaluated by the University of Birmingham, and we will have the results in June. We will take a view on the findings of the pilot before making any decisions on extending the system. Where standard operating procedures are concerned, guidance has now been developed with the Healthcare Commission. That guidance is currently out for comment with the controlled drugs reference group. The requirement to have standard operating procedures will be established in regulation and will also be placed in other regulations, such as the general medical services regulations for GPs, later this year. On the issue of property of the Crown, controlled drugs are already subject to legislation that controls who is allowed to possess the drugs. A bereaved family, for example, has no right to possess controlled drugs other than to take them back to an appropriate person for safe disposal. Only the person who has been prescribed the controlled drugs is allowed to possess them, unless someone is returning them for safe disposal. NHS prescriptions are already sent to the Prescription Pricing Division of the Business Services Authority. Private prescriptions will be sent to the PPD following changes to the Misuse of Drugs Regulations, expected in early July. Guidance was issued in March of this year. I am sure that I have not answered all the noble Earl’s questions. If I have not, I will do so in writing and he will receive the information in good time for Third Reading.