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Controlled drugs: safe use and management

About

What is covered

This NICE Pathway covers systems and processes for using and managing controlled drugs safely in all NHS settings except care homes. It aims to improve working practices to comply with legislation and have robust governance arrangements. It also aims to reduce the safety risks associated with controlled drugs.

Updates

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Short Text

Everything NICE has said about the general safe use and management of controlled drugs in all NHS settings except care homes in an interactive flowchart

What is covered

This NICE Pathway covers systems and processes for using and managing controlled drugs safely in all NHS settings except care homes. It aims to improve working practices to comply with legislation and have robust governance arrangements. It also aims to reduce the safety risks associated with controlled drugs.

Sources

NICE guidance and other sources used to create this interactive flowchart.
Controlled drugs: safe use and management (2016) NICE guideline NG46

Quality standards

Quality statements

Effective interventions library

Effective interventions library

Successful effective interventions library details

Implementation

NICE has produced resources to help implement its guidance on:
Controlled drugs: safe use and management

Information for the public

NICE has written information for the public on each of the following topics.
Controlled drugs: safe use and management

Pathway information

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Supporting information

An organisation's controlled drugs accountable officer or nominated person should:
  • review controlled drug-related concerns or incidents and take any action needed on a case-by-case basis
  • share information and learning throughout the organisation from controlled drug local intelligence networks.
Keep records to provide an audit trail for the supply, administration and disposal of controlled drugs, and the movement of them from one location to another.
Regulation 27 of the 2001 Regulations requires that controlled drugs held as stock by health professionals or organisations must only be destroyed in the presence of an authorised person. The Act designates certain people as authorised witnesses. This includes any police constable and inspectors of the General Pharmaceutical Council. The lead controlled drugs accountable officer of NHS England may also appoint people as authorised witnesses.
Regulation 27 of the 2001 Regulations requires that controlled drugs held as stock by health professionals or organisations must only be destroyed in the presence of an authorised person. The Act designates certain people as authorised witnesses. This includes any police constable and inspectors of the General Pharmaceutical Council. The lead controlled drugs accountable officer of NHS England may also appoint people as authorised witnesses.
A record of the care provided to a person in a health or social care setting. Care records can be written or electronic. They may include notes of clinical decisions; medicines prescribed and administered, or discharge information. The type of care record may vary depending on the arrangements of the care setting. Care records enable health and social care practitioners to have access to essential information about a person's care to help provide safe treatment.
A person (defined as fit, proper and suitably experienced) who is appointed to ensure that systems for the safe management and use of controlled drugs are secure within their own organisation or in those they have a contract with. See Regulation 8 of the 2013 Regulations for more information.
A person (defined as fit, proper and suitably experienced) who is appointed to ensure that systems for the safe management and use of controlled drugs are secure within their own organisation or in those they have a contract with. See Regulation 8 of the 2013 Regulations for more information.
Designated bodies in England are NHS foundation trusts, NHS trusts, English independent hospitals, NHS England and the headquarters in England of regular or reserve forces. See Regulation 7 of the 2013 Regulations for more information.
A controlled automatic device for administering medicines, including controlled drugs, at a set rate of dose per time. An example of this is a syringe pump.
A local intelligence network is drawn from representatives of designated and responsible bodies. It is for the NHS England lead controlled drug accountable officer to determine the number and membership of local intelligence networks appropriate to their area. Local intelligence network members have certain duties and functions set out in Regulations 14, 15 and 16 of the 2013 Regulations. These include a duty to cooperate with other local intelligence network members in identifying cases where action may be appropriate.
A local intelligence network is drawn from representatives of designated and responsible bodies. It is for the NHS England lead controlled drug accountable officer to determine the number and membership of local intelligence networks appropriate to their area. Local intelligence network members have certain duties and functions set out in Regulation 14, Regulation 15 and Regulation 16 of the 2013 Regulations. These include a duty to cooperate with other local intelligence network members in identifying cases where action may be appropriate.
A record of all the medicines the person is taking when in an inpatient setting. Each medicine entry has to be signed by a prescriber. The record forms the authority to administer the medicine.
Regulation 8 of the 2013 Regulations, places a requirement on NHS England to nominate or appoint a fit, proper and suitably experienced person to be NHS England's lead controlled drugs accountable officer for each of its local intelligence network areas. A lead controlled drugs accountable officer can be responsible for one or more local intelligence network areas.
Regulation 8 of the 2013 Regulations, places a requirement on NHS England to nominate or appoint a fit, proper and suitably experienced person to be NHS England's lead controlled drugs accountable officer for each of its local intelligence network areas. A lead controlled drugs accountable officer can be responsible for one or more local intelligence network areas.
Responsible bodies in England are regulatory bodies that include: designated bodies, clinical commissioning groups, NHS Protect, the Prescription Pricing Division of the NHS Business Services Authority, the Care Quality Commission, local authorities, and police forces. See Regulation 6 of the 2013 Regulations for more information.
A standard operating procedure specifies in writing what should be done, when, where and by whom in order to manage safely and accountably any set of processes. For example the management of controlled drugs.
A person who witnesses controlled drugs related activities such as administration or destruction. This can be a registered health professional, for example a doctor, pharmacist, nurse or pharmacy technician, or another competent health or social care practitioner depending on the setting and local standard operating procedure.

Glossary

British National Formulary
removal of controlled drugs for unauthorised use
a pharmacy that is not owned by the organisation it supplies medicines to (a different legal entity), for example a community pharmacy that supplies medicines to a hospital
Health and Social Care Information Centre
an onsite pharmacy owned by the organisation it supplies medicines to (within the same legal entity), for example a hospital or prison pharmacy that supplies medicines within the organisation
an onsite pharmacy owned by the organisation it supplies medicines to (within the same legal entity)
in the context of the Misuse of Drugs (Amendment) (No. 2) (England, Wales and Scotland) Regulations 2015, this is the form approved by the Secretary of State, the Welsh Ministers or the Scottish Ministers, for requisitioning Schedule 2 and 3 controlled drugs
a person who is not involved in the day-to-day handling of controlled drugs who has been appointed to oversee the management and governance of activities related to controlled drugs
an incomplete supply of a requested drug, for example when a pharmacy does not have the full quantity of a medicine requested by prescription
prescription for a regular medicine on a repeat basis without the need for consultation with a prescriber
controlled drugs that have not been issued or dispensed to a patient, but are kept by the healthcare provider or health professional for administration or supply
controlled drugs that have not been issued or dispensed to a patient, but are kept by the healthcare provider or health professional for administration or supply
the total dose of opioid (often converted to morphine equivalent daily dose for comparison) that is taken in a 24-hour period
medicines that are taken when they are needed to manage a symptom, for example a pain killer for short-term pain

Paths in this pathway

Pathway created: April 2016 Last updated: October 2020

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