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.
Yorkshire and the Humber
Yorkshire and the Humber Controlled Drugs (CD) team is led by the Lead Controlled Drug Accountable Officer (CDAO) for the region supported by the CDAO team.
Gazala Khan Lead Controlled Drug Accountable Officer
Mandi Silver Project Co-ordinator
Contact email firstname.lastname@example.org
North East (North Cumbria, Tyne and Wear) Controlled Drugs (CD) team is led by the Lead Controlled Drug Accountable Officer (CDAO) for the region supported by a Controlled Drugs Accountable Office and a small team from North of England Commissioning Support Unit (NECS).
|Gazala Khan||Lead Controlled Drug Accountable Officer|
|Dr James Gossow||Controlled Drugs Accountable Officer|
|Ken Dale (NECS)||Controlled Drug Liaison Officer (CDLO)
|Emma Post (NECS)||Senior Medicines Optimisation Technician
North East and North Cumbria ICB
Tel: 0191 2172983
|Victoria Bennett (NECS)||Senior Medicines Optimisation Technician
North East and North Cumbria ICB
Tel: 01642 745429
All staff can be contacted by email on email@example.com
Further information can be found on the team website: https://medicines.necsu.nhs.uk/controlled-drugs/
The website contains guidance documents, incident reporting forms, destruction request forms, previous and current copies of the CD Learning bulletin applicable to the North East.
Yorkshire and the Humber
CD Reporting Tool upgrade – 1 December 2022
Please take time to read the below document explaining changes to the reporting process.
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
Organisations that do have their own Accountable Officer (designated bodies) are required to send a summary of concerns relating to controlled drugs in an ‘occurrence report’ to the accountable officer at NHS England.
This information is requested every three months and can be submitted online at www.cdreporting.co.uk.
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, however should ensure they have a ‘T28 exemption’ from the Environment Agency that permits this activity for the relevant registered premises.
You can request an authorised witness online at http://www.cdreporting.co.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.
- Complete a destruction request via the CD Reporting Tool http://www.cdreporting.co.uk.
- Complete the authorised witness application via the CD Reporting Tool.
PLEASE NOTE: You must complete the destruction request and authorised witness application.
Once the application has been assessed and regulatory checks have been completed the CDAO will determine to issue an Authorised Witness status limited to 28 days to witness the destruction of controlled drugs with the quantities listed on your portal request. The Authorised witness will be issued with guidance to help with record keeping.
Providers who are unable to apply for an Authorised Witness can submit a destruction request via the CD Reporting Tool http://www.cdreporting.co.uk. and the CD team will allocate an approved witness.
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 in excess of 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.
Where an NHS England CDAO designates Authorised Witnesses for a corporate body then the responsibility for the provision of Authorised Witnesses to witness the destruction of obsolete CDs within their premises rest with the body corporate. A corporate body may contract with an independent Authorised Witness to facilitate the witnessed destruction of obsolete CDs.
Multiple pharmacies can register and apply for witnesses to be authorised by completing the form below and returning to firstname.lastname@example.org
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. A ‘T28 exemption’ must also be in place for this to be undertaken.
Private Prescribers (Medical and Dental)
Private prescribers who want to obtain Controlled Drugs stock or obtain FP10PCD stationery, should complete the following forms;
Completed forms should be returned, along with scanned copies of 2 forms of ID, one with a photo to email@example.com
Please ensure the forms are fully completed and provide us with the full contact details for two referees; one should the applications Responsible Officer and the other their appraiser. We request that referees are notified in advance of the application being made so that NHS England can contact them.
Please note any omissions in information will delay the application.
Usual application processing can take up to 30 working days after receipt of a fully completed and accepted application form. Please note it can take longer than this for complex applications and where the application has not been completed correctly.
Community Pharmacy Private CD Code
We will review your application and provide you with your PIN once approved.
CD LIN (Local Intelligence Networks)
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 CD LINs membership comprises of the groups below:
- North Yorkshire & Humber LIN
- South Yorkshire LIN
- West Yorkshire LIN
Network meetings for each group are 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 firstname.lastname@example.org
This page contains links to resources that will be of use to healthcare professionals who work with controlled drugs.
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 email@example.com.