Cathy Cooke discusses recommendations in NICE Guideline 46 on the safe use and management of controlled drugs

cooke cathy

Read this article to learn more about:

  • implementing NICE Guideline 46
  • establishing processes for the management of controlled drugs
  • steps to take when prescribing controlled drugs.

Key points

GP commissioning messages


In her foreword to the 2004 Fourth Report on the Shipman Inquiry, Dame Janet Smith explained that her recommendations sought to strengthen statutory requirements and improve systems of inspection and monitoring.1 Healthcare professionals should, however, be able to fulfil their primary role of providing care to patients in genuine need without excessive barriers or the burden of administrative tasks. What is necessary is a balance, to prevent abuse with a minimal effect on the delivery of appropriate and necessary health care.1

The Government published Safer management of controlled drugs,2 its response to The Shipman Inquiry: Fourth Report, in December 2004. It suggested changes including the requirement for healthcare organisations to appoint a 'Proper Officer' (Controlled Drug Accountable Officers [CDAOs]), and placed a duty of collaboration on local and national agencies (such as professional regulatory bodies and police forces) to share intelligence and take action when evidence of misuse of controlled drugs is uncovered.2 Significant legislative changes have also been introduced to the Misuse of Drugs Act 1971 to strengthen the governance arrangements for controlled drugs.3

Why the guideline is needed

In 2014, approximately 1065 million prescription items were dispensed in the community.4 Of this total, around 61 million (6%) were for a controlled drug (21 million Schedule 2 and 3, 15 million Schedule 4, and 25 million Schedule 5).5 Although this represents a small proportion of the total number of medicines prescribed, there is the potential for high risk of harm with inappropriate use (either through poor prescribing or incorrect use) or diversion. One study of opioid prescribing trends found that over the 7-year period examined, opioid prescribing almost doubled for weaker opioids and increased sixfold for stronger opioids.6 Prescribing of stronger opioids was largely to patients with unspecified non-malignant pain rather than to those with recorded diagnoses of a specific disease. The study concluded that much of the variation in prescribing practice may be attributed to practice team and clinician behaviour.6

NICE Guideline 46

NICE Guideline (NG) 46 on Controlled drugs: safe use and management (see Boxes 1 and 2, below) provides recommendations developed with the aim of bringing together legislation, policy, good practice advice, and published evidence in order that organisations and individuals can build on the work done so far to ensure that systems and processes are robust and effective without interfering with appropriate use of controlled drugs and good clinical care.3

Box 1: NICE Accreditation Mark

NICE accreditation mark

NICE Guideline 46 on Controlled drugs: safe use and management has been awarded the NICE Accreditation Mark.

Box 2: NICE Pathways

NICE pathways logoThis NICE guidance is part of the NICE Controlled drugs: safe use and management pathway.

The guideline 'tools and resources' include a baseline assessment tool,7 which can help identify areas that need development. Key priorities for implementing NG46 are shown in Box 3 (below).

Box 3: Key priorities for implementing NICE NG463

Key priorities for implementation of NICE NG46 include:

  • ensuring all prescribers, when initiating a controlled drug, comply with the recommendations for prescribing, including making and recording prescribing decisions, monitoring and reviewing response to treatment, and providing information and advice
  • ensuring all patients who have an ongoing prescription for a controlled drug have regular reviews and that the relevant information (as detailed in the guideline) is documented in their care record. (As the number of patients prescribed a controlled drug is likely to be large, the potential workload may be significant. Decide on a set of groups according to risk, run reports, and prioritise implementation for the highest risk group)
  • reviewing existing systems, policies, and standard operating procedures to ensure they cover all activities—have a process in place for regularly reviewing and auditing policies and procedures
  • appointing a nominated person if not already in place, to ensure processes are set up for safe use and management of controlled drugs, including the reporting and investigating of concerns
    • the nominated person should engage with the controlled drug local intelligence network.

Guideline recommendations

The recommendations in NG46 fall into nine categories (see Box 4, below). The following sections highlight key elements particularly relevant to primary care but do not necessarily cover all groups or recommendations within a group. Reference should be made to the guideline for the complete list and details of each recommendation.

Box 4: Categories of recommendations in NICE NG463

NICE NG46 has nine groups of recommendations dealing with:

  • developing and establishing systems and processes for organisations—governance; accountability; policies; processes and procedures
  • record keeping for organisations—controlled drug registers; requisitions; invoices
  • risk assessment for organisations—handling controlled drugs; incident reporting; destroying controlled drugs
  • processes for reporting controlled drug-related incidents
  • prescribing controlled drugs—making and recording prescribing decisions; providing information; reviewing repeats and anticipatory prescribing
  • obtaining and supplying controlled drugs—standards and safety checks; providing information and advice; recording supplies; obtaining stock; part supplies
  • administering controlled drugs—standards and safety checks; providing information and advice; records; continuous administration; recording left over drugs
  • handling controlled drugs—records; providing information and advice on storage; destruction and disposal
  • monitoring the use of controlled drugs—governance and safety; reporting concerns and incidents; identifying and reporting trends and barriers; reviewing and sharing information.

Systems and processes for organisations

The recommendations on systems and processes clarify what should mostly already be in place, but it may be a useful exercise to check that systems link effectively and processes/procedures cover all activities, are fit for purpose, and are regularly reviewed.

Governance arrangements and accountability

Clear lines of responsibility and accountability should be agreed for controlled drugs in an organisation's contracts.

As no primary care organisations are 'designated bodies' under the relevant legislation, they should consider appointing a nominated person to work in accordance with the governance arrangements and make sure processes are in place for safe use and management of controlled drugs, including the reporting and investigating of concerns. The nominated person should liaise with the NHS England lead controlled drugs accountable officer and local intelligence network members.3

Policies, processes, and procedures

A controlled drug policy and standard operating procedures should be in place for storing, transporting, destroying, and disposing of controlled drugs. There should be processes for developing, reviewing, updating, sharing, and complying with controlled drugs-related standard operating procedures, and for action of controlled drug-related patient safety alerts and national safety guidance.3

For oversight of controlled drugs prescribing at practice or CCG level there should be processes for accessing prescribing data to identify prescribing trends: the reasons for high, increasing, or very low volume prescribing.3 If CCGs do not already have processes in place, then this is a key area to address. Regular monitoring of practices can also identify where support may be needed in managing patients' complex needs.

Processes and procedures for storage, stock checks, and audits

GP practices that maintain a stock of controlled drugs must ensure that they have standard operating procedures in place for storage, stock checks, and audit of the register and cabinet. The frequency of stock check should be weekly for most organisations, but can be more or less depending on the circumstances.3 Less frequent checks may be appropriate where access is infrequent and limited to a small number of people.

Processes and procedures for transportation

Consider what measures need to be in place for security when transporting drugs in, for example, doctors' locked bags and for record keeping when controlled drugs are moved for use at a different location.3

Processes and procedures for destruction and disposal

Organisations must have arrangements in place for destruction and disposal of controlled drugs in line with the relevant regulations. Destruction will need to be witnessed by an authorised person (see NICE Guideline 46 for details).3

The guideline recommends developing standard operating procedures based on local arrangements for destroying and disposing of controlled drugs that belonged to a person who has died.3 This is to avoid, by timely removal from the property, the risk of inappropriate access to or diversion of drugs.

Record keeping for organisations

A separate controlled drugs register must be kept for each of the premises where Schedule 2 controlled drugs are stored.3 (This would apply to GP practices with a branch surgery and also doctors' bags.)

Prescribing controlled drugs

The recommendations in this section reiterate what is, in fact, good practice for prescribing any medicine, but are essential in managing risk for controlled drugs, in particular opioids. The decision to prescribe a controlled drug should take into account the benefits and risks for the patient including dependency, overdose, and diversion. What other medicines (both prescribed and non-prescribed) is the patient taking, with particular consideration to other centrally acting drugs? If the proposed drug is an opioid, is the patient opioid naïve? Evidence-based sources of information should be used to inform decision making.3 Useful information is available, for example, from the Royal College of Anaesthetists Faculty of Pain Medicine: Opioids aware8 and The British Pain Society website.

When the prescribing decision has been made, document the indication and regimen in the patient's care record. Titrate the dose to clinical need, if necessary, and adjust until there is a good balance between benefits and harms for the individual. Discuss and agree with the patient how the treatment will be reviewed and monitored, and record this in the care record. 'When required' medicines should have a clear instruction for when and how to take or use the drug documented in the patient record, with dosage and frequency or maximum daily amount on the prescription for inclusion on the dispensing label. Consideration of a patient's existing supply should inform the quantity prescribed to avoid excessive stock being held by the patient or their carer. If a repeat prescription is appropriate, consideration of the drug and the patient's circumstances should inform the frequency of review for authorisation of a continuation of repeats.3

Prescribers should follow local and national guidelines on route, dose (including dose conversion), and formulation, recording their justification for any deviation. Use a recognised opioid dose conversion guide when switching drugs and ensure total opioid load is considered. Information should be provided to the patient and their carers to include expected length of treatment, how long the medicine will take to work, what it is for, how to use immediate-release and sustained-release formulations, and effect on driving.3

Healthcare professionals have, on occasion, felt reluctant to raise queries with prescribers relating to controlled drug prescriptions because of their experience of uncooperative responses, even though the inquirer has a professional responsibility to clarify any concerns they may have. The guideline includes a specific recommendation that prescribers should be prepared to discuss their decision with other healthcare professionals who require further information about the prescription.3

Monitoring use

Recommendations on monitoring the use of controlled drugs include the responsibilities for NHS England lead CDAOs and organisation CDAOs. For organisations not required under legislation to appoint a CDAO, such as clinical commissioning groups, the nominated person should participate in the local intelligence network and report controlled drug-related incidents to the NHS England CDAO. They should share information and learning from this participation throughout their organisation.


Implementing the recommendations from NICE NG46 will allow individuals and organisations to check and improve their existing systems and processes to ensure they are effective in managing the risks associated with controlled drugs. Better monitoring of controlled drug use, and strengthened networks for sharing concerns, will identify issues such as problem prescribing patterns and possible misuse, allowing earlier intervention to manage and reduce risk. Strengthened networks will facilitate the sharing of good practice across the healthcare community.

Better management of controlled drugs across primary care will improve safety and effectiveness for people being treated with controlled drugs and support healthcare professionals in their practice.

Key points

  • The recommendations bring together legislation, policy, good practice advice, and published evidence to build on the work done to date following the Shipman Inquiry Fourth Report
  • Many of the recommended systems and processes will already be in place within organisations and individual practices. Baseline assessment will identify where they need to be improved
  • Good communication and accurate record keeping are important for safe and effective use of controlled drugs, to ensure that people are using them only where they are of benefit
  • Healthcare professionals should query any unusual or irregular practice in relation to controlled drugs
  • Engagement with local intelligence networks supports the sharing of information at local and national levels, enabling earlier identification of problems and the spread of good practice.

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GP commissioning messages

written by Dr David Jenner, GP, Cullompton, Devon

  • GPs need to have robust systems and SOPs for the storage and management of controlled drugs to comply with the law:
    • this is a major focus of inspection for the CQC
  • Commissioners of primary care (NHS England and CCGs) should work alongside medicines optimisation leads to ensure all GP practices understand and comply with the regulations and good practice guidance
  • Dispensing GP practices have additional responsibilities in controlled drug management and this should be monitored through the DSQS
  • General practices could look to obtaining specific support from a practice-employed pharmacist in order to help them manage this agenda and in line with proposals in the general practice Five year forward view.9

SOPs=standard operating procedures; CQC=Care Quality Commission; DSQS=Dispensary Services Quality Scheme

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  1. Smith J. The Shipman Inquiry: Fourth Report. The regulation of controlled drugs in the community. Command Paper Cm 6249. The Stationery Office, 2004. Available at: (accessed 8 August 2016).
  2. HM Government. Safer management of controlled drugs: the government's response to the Fourth Report of the Shipman Inquiry. Available at: (accessed 8 August 2016).
  3. NICE. Controlled drugs: safe use and management. NICE Guideline 46. NICE, 2016. Available at: (accessed 8 August 2016).
  4. Health and Social Care Information Centre. Prescriptions dispensed in the community: England 2004–14. HSCIC, 2015. Available at: (accessed 8 August 2016).
  5. Care Quality Commission. The safer management of controlled drugs. Annual Report 2014. CQC, 2015. Available at: (accessed 8 August 2016).
  6. Foy R, Leaman B, McCrorie C et al. Prescribed opioids in primary care: cross-sectional and longitudinal analyses of influence of patient and practice characteristics. BMJ Open 2016; 6: e010276. doi:#10.1136/bmjopen-2015-010276.
  7. NICE. Controlled drugs: safe use and management. NICE Guideline 46. Tools and resources, baseline assessment. Available at: (accessed 8 August 2016).
  8. Royal College of Anaesthetists, Faculty of Pain Medicine. Opioids aware: a resource for patients and healthcare professionals to support prescribing of opioid medicines for pain. Available at: (accessed 8 August 2016).
  9. NHS England. Five year forward view. 2014. Available at: