National Prescribing Centre - A guide to good practice in the management of controlled drugs in primary care (England) - 3 Dec

Link to guide

Background
This third edition of the controlled drugs guide (CDG) takes into account the significant legislative changes, introduced by the Government to strengthen the governance arrangements for controlled drugs (CDs) since publication of the first edition in December 2005. A number of changes affecting the prescribing, record keeping and destruction of CDs were introduced as a result of amendments to the Misuse of Drugs Regulations (MDRs) 2001. The Health Act, which received royal assent in July 2006, enabled Regulations to be laid relating to governance and monitoring of CDs which came into effect in England on 1 January 2007. Since then further changes have been introduced which have been included in this third edition of the CDG.

Changes to primary legislation and the MDRs 2001 apply to Scotland, England and Wales. Northern Ireland has its own MDRs - MDRs (Northern Ireland) 2002 - although these largely mirror the MDRs 2001. However, arrangements for delivering new requirements may differ between each of the countries.

Purpose of the guide
This CDG is primarily aimed at developing good practice for the management of CDs in primary care in England, but also encompasses issues raised at the interfaces between primary, secondary and social care. Although this document is not aimed at the hospital setting, much of the content will have relevance to the management of CDs across all NHS and non-NHS settings. The Department of Health (DH) has issued specific guidance on the management of CDs in secondary care (updated following changes to the MDR 2001 made in July 2007). This guidance also reflects the recent changes that have taken place to update working practices: the developing roles of healthcare professionals, the need to optimise skill mix and the role of pharmacy technicians and other healthcare professionals, including operating department practitioners. It describes how these changes work within the existing legal framework for CDs.

This CDG aims to identify robust systems for obtaining, storing, supplying, recording, monitoring and disposing safely of CDs, while at the same time helping to ensure appropriate and convenient access for those patients that require CDs. It does not advise on the clinical choice and application of CDs - the focus being directed towards defining processes for their appropriate and safe use once selected.

Since the publication of the second edition of this Controlled Drugs Guide in February 2007, work should have been undertaken towards full implementation of the recommendations within the CDG. In many cases it will have required a systematic approach to improve the management and control of CDs, enhancing patient and public safety, whilst at the same time ensuring that healthcare professionals are not overburdened with additional bureaucracy resulting in reluctance to prescribe CDs. The Care Quality Commission Annual Report (2008), ‘The safer management of controlled drugs’, concluded that there had been significant activity to help ensure that CDs are managed safely and effectively. However, ongoing activity and vigilance is required to sustain the positive developments that have been achieved in the last two years.

Key audiences

• The CDG should be of value in a wide range of settings where CDs are used, including:
• GP and dental practices
• Pharmacies
• Midwifery services
• Out-of-hours services
• Patients’ own homes
• Care homes
• Community nursing services
• Community palliative care services
• Substance misuse services
• Hospices
• Prison services
• Ambulance services/paramedics
• Intermediate care services

When an organisation commissions services involving CDs, either within the NHS or from non-NHS organisations, they should ensure that the same standards and good practice frameworks for the management of CDs apply in these settings. It is strongly recommended that these standards and good practice frameworks should be included in all contracts or service level agreements (SLAs) for provider services. These standards should then be monitored by the commissioning organisation as part of the contract monitoring process.
 

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