Please note, some of this content was published before July 1, 2022. The Health and Care Act 2022 introduced significant changes to how the NHS in England is organised and these may not be reflected below.

Our statutory duty

NHS England has a statutory duty to ensure that safe systems are in place for the management and use of controlled drugs. This is to prevent harm to patients and staff from any misuse of controlled drugs.

Controlled Drugs are drugs that are subject to high levels of regulation as a result of government decisions about those drugs that are especially addictive and harmful.

Controlled drugs use regulations

In 2007, The Controlled Drugs (Supervision of Management and Use) Regulations 2006 were introduced as part of the Government’s response to the Shipman Inquiry’s Fourth report in 2004.

The aim of these regulations was to strengthen the governance arrangements for the use and management of Controlled Drugs. Controlled Drugs (CDs) are essential to modern clinical care. As such, it is essential that NHS England enforces robust arrangements for the management and use of CDs to minimise patient harm, misuse, and criminality.

As a consequence of passing the Health and Social Care Act 2012, the 2006 regulations have been revised to reflect the new architecture in the NHS in England. The Controlled Drugs (Supervision of Management and Use) Regulations 2013 came into force in England on 1 April 2013.

These regulations require NHS England and other ‘designated bodies’ such as NHS trusts and independent hospitals to appoint Accountable Officers for Controlled Drugs and requires those Accountable Officers to ensure safe systems are in place for the management and use of controlled drugs.

Our teams

The lead controlled drug accountable officer (CDAO) for North East and Yorkshire Region is Gazala Khan and the region is managed by two teams, one in Yorkshire and Humber and the other in the North East. These teams cover North East and North Cumbria; Humber and North Yorkshire; West Yorkshire and South Yorkshire Integrated Care Board areas.

Yorkshire and the Humber CDAO team

• Abbas Bashir, CD Governance Manager
• Matt Auckland, Clinical Advisor (Pharmacy)
• Mandi Silver, Project Coordinator
• Lesley King, Team Administrator

All staff in the Yorkshire and Humber team can be contacted by email via england.yhcdao@nhs.net

North East and North Cumbria CDAO team

The North East (North Cumbria, Tyne and Wear) is supported by a small team from North of England Commissioning Support Unit (NECS).

• Ken Dale (NECSU), Controlled Drugs Accountable Officer Controlled Drug Liaison Officer (CDLO) – Tel: 07919071655
• Naida Rafiq (NECSU), Senior Medicines Optimisation Pharmacist – Tel: 07769 643453
• Emma Post (NECSU), Senior Medicines Optimisation Technician – Tel: 07900 405470
• Victoria Bennett (NECSU), Senior Medicines Optimisation Technician – Tel: 07867 143246

All staff in the North East team can be contacted by email via england.cumbrianortheast-cds@nhs.net

Further information can be found on the NECSU team website.

The NECS website contains guidance documents, previous and current copies of the CD Learning bulletin applicable to the North East and Yorkshire Region.

Processes

Reporting incidents involving controlled drugs

All incidents involving controlled drugs should be reported to the Accountable Officer. This provides assurance that any risks have been mitigated and prompts any necessary action to be taken. Reporting also allows for the identification of themes in reported incidents from which learning can be shared across the system.

Staff in organisations that do not have their own Accountable Officer should report their incidents to the accountable officer at NHS England. You can do this online at www.cdreporting.co.uk.

Occurrence reporting

If an organisation has a CQC registered accountable officer, they are considered to be a Designated Body and should have their own internal process for recording and monitoring CD incidents. They are required to submit a quarterly report via the Occurrence Reporting module on the CD Portal.

This information is requested every quarter and can be submitted online at www.cdreporting.co.uk. Below is the schedule and deadlines for each quarter.

Any organisation that does not have a CQC registered accountable officer should report any CD incidents via the CD Incident Module on the CD Portal (see above).

Destruction of controlled drugs

All stocks of Schedule 2 Controlled Drugs must be witnessed by a person authorised by the Lead Accountable Officer for NHS England.

Any stocks of Controlled drugs in Schedule 3, and 4 (Part 1) must be denatured before being disposed of by healthcare staff that are lawfully in possession of these.

It is a legal requirement for premises to have a valid T28 Exemption certificate before any controlled drugs destructions are undertaken. If you do not have a certificate you can register via T28 waste exemption: sort and denature controlled drugs for disposal – GOV.UK (www.gov.uk).

A registered healthcare professional who is not responsible for the day-to-day use or management of CDs at the provider premises can apply to act as an authorised person and witness the destruction of Schedule 2 Controlled Drugs.

Providers will need to nominate a registered healthcare professional; this could be a pharmacist or a pharmacy technician for pharmacies or GP/Nurse for GP practices.

The nominated person will need to complete the Temporary Authorised Witness to the Destruction of Controlled Drugs.

Once the application has been assessed and regulatory checks have been completed the CDAO will determine to issue an Authorised Witness License limited to 28 days to witness the destruction of controlled drugs with the quantities listed in the Authorised Witness application. The Authorised witness will be issued with guidance to help with record keeping.

Community pharmacies – multiples

NHS England Controlled Drugs (Supervision of management and use) regulations 2013 Single Operating Model; Annex 6: Authorisation of witnesses to destroy Controlled Drugs highlights the following for Community Pharmacies – Multiples:

NHS England anticipates that corporate bodies operating more than 5 or more pharmacy premises will seek to have suitably trained employees designated as Authorised Witnesses by the appropriate NHS England CDAO. 

A corporate body operating 5 or more pharmacies may apply to the appropriate NHS England CDAO to designate suitably trained individual employees and/or class of employees as Authorised Witnesses. 

The appropriate NHS England CDAO is the one for the regional team where the corporate body’s registered office is located.

The appropriate NHS England CDAO may designate suitably trained individual employees and/or class of employees in a corporate body as Authorised Witnesses where the individuals described are not routinely involved in the management and use of CDs in the premises in which they are acting as an Authorised Witness.

The Superintendent Pharmacist of the corporate body is accountable to the appropriate NHS England CDAO for the governance arrangements around the witnessed destruction of CDs in their premises.

Please email for further information:

• Yorkshire and Humber england.yhcdao@nhs.net
• North East and North Cumbria email england.cumbrianortheast-cds@nhs.net

Patient returns of controlled drugs

Patient return Controlled Drugs for Schedule 2, 3 and 4 (Part 1) can be destroyed without the presence of an authorised witness however the destruction should be witnessed by another colleague and logs kept of destructions e.g. a Controlled Drugs Patient Returns Book.

It is a legal requirement for premises to have a valid T28 Exemption certificate before any controlled drugs destructions are undertaken. If you do not have a certificate you can register via T28 waste exemption: sort and denature controlled drugs for disposal – GOV.UK (www.gov.uk).

Private prescribers (medical and dental)

Please email for further information and an application form:

• Yorkshire and Humber england.yhcdao@nhs.net
• North East and North Cumbria email england.cumbrianortheast-cds@nhs.net

Community pharmacy private controlled drugs (CD) code

If you work at a community pharmacy in Yorkshire and Humber and need a private CD contractor code, please email england.yhcdao@nhs.net.

North East and North Cumbria pharmacies should contact their integrated care board (ICB) primary care team via nencicb-tv.pharmacyandoptomerty@nhs.net

Controlled drugs local intelligence networks (CD LIN)

The regulations require the NHS England Accountable Officer to facilitate a ‘local intelligence network’ (LIN) to share information and intelligence on the safe use and management of controlled drugs.

The Yorkshire and the Humber CD LIN meeting is held twice yearly. If you are a designated body and would like to join or update details of your membership, please email the Controlled Drugs team at england.yhcdao@nhs.net.

The North East and North Cumbria CD LIN meeting is held twice yearly. If you are a designated body and would like to join or update details of your membership, please email the Controlled Drugs team at england.cumbrianortheast-cds@nhs.net

Useful links

NHS England — North East and Yorkshire » Useful links

If you have any information, intelligence, or looking for support and guidance, please get in touch with a member of the team at Yorkshire and the Humber via england.yhcdao@nhs.net