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Medicines and pharmacy

Safer management of controlled drugs: early action

Last modified date:

8 February 2007

The government's response to the Shipman Inquiry was published in December 2004 as Safer management of controlled drugs.

Introduction and Background

The Shipman Inquiry was set up on 31 January 2001 and was chaired by Lady Justice Janet Smith DBE as an independent public inquiry into the issues arising from the case of Harold Shipman. The Inquiry's Fourth Report was published on 14th July 2004. It focuses on the methods used by Harold Shipman to divert large quantities of potentially lethal controlled drugs and the reasons it was possible for him to do so for so long without detection.

The Shipman Inquiry concluded that there were serious shortcomings in current systems, and made a number of recommendations to strengthen the prescribing of controlled drugs and the ability to monitor their movement from prescriber to dispenser to patient (the 'audit trail').

The government's response was published in December 2004 as Safer management of controlled drugs. The response accepts the case for some strengthening of current systems provided this can be done in a way that does not impede appropriate use of controlled drugs to meet patient needs. A comprehensive action programme to address the recommendations of the report is set out in the final chapter of the response.

Action so far

Some early changes in the legislation governing controlled drugs have now been implemented by amendments to the Misuse of Drugs Regulations. The principal changes are to allow:

all details on prescriptions for controlled drugs except the signature to be computer generated;
computerisation of controlled drugs registers for drugs listed in Schedules 1 and 2;

Other measures will:

extend the list of controlled drugs which Extended Formulary Nurse Prescribers may prescribe for certain medical conditions (changes to the Prescription Only Medicines (Human Use) Order to bring these measures into effect will follow later this year).;
amend the list of allowable drug paraphernalia to include ascorbic acid.

The changes come into force on 14 November 2005. You can access full details and a copy of Statutory Instrument 2005 No 2864 by clicking on the link www.circulars.homeoffice.gov.uk and is numbered HOC 48/2005.

Controlled Drugs: Amendments To The Misuse Of Drugs Regulations 2001 (opens new window)

Action planned for 1 April 2006

A number of further changes will be introduced, subject to Parliamentary approval where required, on 1 April 2006. In some cases the changes will be affected through professional guidance and in others through further amendment to the Misuse of Drugs Regulations. The key changes are:

Introduction of special forms for any private prescription of schedule 2 & 3 controlled drugs dispensed by community pharmacists. Records of these prescriptions will be held on a central database so that they can be monitored by local PCTs;
Some changes to the NHS prescription form to allow all prescriptions for controlled drugs to be correctly allocated to the individual prescriber and (subject to strict safeguards on confidentiality) to the individual patient;
Modified arrangements for the dispensing of NHS prescriptions for schedule 2 & 3 controlled drugs, including a new requirement for patients or other people collecting medicines on their behalf to sign for them;
Duration of any prescription for schedule 2, 3 & 4 controlled drugs to be restricted to 28 days;
Introduction of 28 day maximum quantity on prescriptions for schedule 2, 3 & 4 controlled drugs;
Introduction of requirement that all healthcare providers holding stocks of controlled drugs should have and comply with the terms of an agreed Standard Operating Procedure (SOP);
Re-emphasis of professional guidance that doctors should prescribe controlled drugs for themselves or family members only in exceptional circumstances.
Discretion for pharmacists (in closely defined circumstances) to correct technical errors in prescriptions where the prescriber's intention is clear, even if the prescriber cannot be contacted at the time.

Detailed guidance is being developed and will be available in early 2006.

Health Bill - Controlled drugs

The Health Bill, currently before Parliament, contains a series of clauses intended to strengthen the monitoring and inspection of controlled drugs in health and social care settings.

The key elements of the provisions are:

Each healthcare organisation, NHS or private, will be required to nominate an officer of sufficient seniority - an 'Accountable Officer' to ensure that the organisation has robust arrangements for the safe and effective management and use of controlled drugs. In NHS primary care, PCTs will exercise this responsibility on behalf of all the contractors with which it has contracted to provide services.
A duty of collaboration will be placed on other local and national agencies, including professional regulatory bodies, police forces, the Healthcare Commission and the Commission for Social Care Inspection to share intelligence and agree joint action where there is evidence of misuse on controlled drugs issues.
New powers of entry and inspection for authorised officers creates an unambiguous right of entry into all health and social care settings including GP premises.
The Healthcare Commission will be required to assess the performance of all healthcare organisations, public and private, in relation to these responsibilities

Better systems will support the vast majority of healthcare professionals who want to provide the best possible care for patients, but will also deter the small minority who may wish to abuse their professional position.