Controlled Drugs Accountable Officer

Dr. Lisa Byers, Senior Principal Pharmaceutical Officer in the Department of Health (DoH) is the Controlled Drugs Accountable Officer (CDAO) for the DoH, and is based in the Pharmaceutical Advice and Services Directorate, headed by the Chief Pharmaceutical Officer.

Role of the CDAO

The CDAO is responsible for all aspects of Controlled Drugs (CD) management. The legislation that governs the roles and responsibilities of CDAOs are established in The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 (legislation.gov.uk) as amended by The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 (legislation.gov.uk) (referred to hereafter as The CDAO Regulations). The governance arrangements introduced by The CDAO Regulations, have been implemented in a way that supports healthcare professionals and encourages best practice in the use of CD when clinically required by patients.

The CDAOs have responsibilities for arranging safe disposal, auditing and monitoring of others whose work involves controlled drugs within their health care body. These responsibilities include keeping records of the investigation of concerns and taking action where appropriate.

During the assessment of a concern, the CDAO decides if an investigation is required. They may investigate personally or ask another employee to do so. In some cases, the CDAO may ask officers or employees from other responsible bodies to carry out an investigation or joint investigation as permitted in The CDAO Regulations.

The DoH CDAO is responsible for overseeing the safe management and use of controlled drugs in primary care in Northern Ireland.

This includes all independent contractors namely: community pharmacies, GP practices, optometry and dental practices and all other individuals who provide health care services as specified in The CDAO Regulations.

All controlled drug related incidents and concerns arising in primary care health and care settings must be reported to the CDAO and the Medicines Regulatory Group (MRG) via the email ControlledDrugsAccountableOfficer@health-ni.gov.uk and mrg_inspectors@health-ni.gov.uk

This applies to all health and care settings including; GP practices, community pharmacies, dental practices, private providers and nursing and care homes. Where a patient is seen remotely and/or resides outside of NI, incidents still need to be reported to the CDAO if the service is based in NI.

Incidents involving CDs from all schedules should be reported including those from lower schedules (Schedules 4 and 5) such as; benzodiazepines, z-drugs, codeine and dihydrocodeine.

Examples of incidents that should be reported include:

Administration errors
Prescribing errors
Breakages and spillages e.g., opioid liquid or ampoules, methadone
Missing/lost or dropped tablets during dispensing or physical balance checks
Liquid CD discrepancies identified during physical balance checks
Any CD supply discrepancies including those due to differing pack sizes e.g., 30 supplied instead of 28
Unresolved running balance discrepancies
Suspected diversion or criminal activity of prescribed CDs
Concerns about healthcare professionals and staff working in health and care settings.
Instalment Opioid Substitution Therapy dispensed without valid prescription or after missed doses
Supervised Opioid Substitution Therapy dispensed as a take-away dose
Dispensing errors, where a patient has or has not taken the CD, for example, mis-selection and dispensed to a patient; Elvanse 30mg capsules instead of Elvanse Adult 30mg capsules, Espranor instead of Subutex, gabapentin instead of pregabalin
Fraudulent prescriptions presented by a person
Theft of CDs from premises by a person accessing the dispensary.

Key responsibilities of the role of the DoH CDAO include:

To encourage proactive discussion about making the use of CDs safer and to support an open reporting culture.
To establish a CDAO Incident Panel as necessary, to ensure appropriate action is taken for the purposes of protecting patients and members of the public in cases where concerns are raised in relation to the management and use of CDs.
To establish and chair a Local Intelligence Network (LIN) in Northern Ireland.
To co-ordinate the publication of Annual Reports which sets out the work of the Regional CDAO’s organisation and of those who attend the LIN.

The Local Intelligence Network (LIN)

The concept of the LIN was introduced under the CDAO legislation to increase collaboration and promote information sharing between healthcare organisations, amongst others, about the use of controlled drugs and about individuals who give cause for concern.

There is a single LIN within Northern Ireland which meets quarterly.

The LIN is constituted from:

CDAO nominated from their Designated Body
Representatives from organisations that have regulatory responsibility (known as Responsible Body)
Representatives from the MRG (Regulatory Authority)

Responsible bodies specified in The CDAO Regulations are:

The Department of Health
The Health Board (now the SPPG)
A HSC trust
Northern Ireland Ambulance Service (NIAS)
Regulation and Quality Improvement Authority (RQIA)
Business Services Organisation (Counter Fraud Service)
A regulatory body*
The Police Service of Northern Ireland

They have the following responsibilities:

A general duty to co-operate with each other regarding relevant persons
Duty to co-operate by disclosing information regarding relevant persons
Have a right to request additional information be disclosed about relevant persons

*A regulatory body could be GMC/NMC/GDC/HPC/Pharmaceutical Society of NI etc

The LIN meets quarterly and enables the sharing of CD concerns and good practice with other responsible bodies regarding the management and use of CDs as per The CDAO Regulations.

Organisations in the LIN membership

CD concerns may be shared within the LIN and highlight issues for other Responsible Bodies and their organisational arrangements and/or responsibilities. It is the responsibility of each attending member to communicate any CD concerns within their organisation. Any information shared must respect the confidential nature of the LIN and the needs and responsibilities of all other LIN members. Membership will include, but will not be limited to:

Designated Bodies:

SPPG
HSC Trusts
Northern Ireland Ambulance Service HSC Trust
Independent Hospitals, Hospices and Clinics.

Contact details (including Accountable Officers) of the above designated bodies can be accessed via the following Department of Health (DOH) link:

Accountable Officer Contact List

Other Responsible Bodies:

Counter Fraud Unit of BSO
The Department of Health Medicines Regulatory Group (The Regulatory Authority)
Regulation & Quality Improvement Authority (RQIA)
Police Service of Northern Ireland
Pharmaceutical Society of Northern Ireland
Nursing and Midwifery Council
General Medical Council
General Dental Council
Health and Care Professions Council

See FAQs for further information about the LIN and the role of the CDAO.

The DoH CDAO may be contacted by email at: ControlledDrugsAccountableOfficer@health-ni.gov.uk

The Role of the CDAO of Designated Bodies

The CDAO Regulations require each designated body, as defined in legislation, to nominate or appoint a CDAO who has overall responsibility for the safe management and use of CDs within those designated bodies, or a group of designated bodies. Following the closure of the Regional Health and Social Care Board (HSCB) the DoH became a Designated Body (for the purposes of Section 17 of the Health Act 2006) and prescribed as a designated body in Regulation 3 (a) in the Controlled Drugs Supervision of Management and Use Regulations 2009 (using transitional provision of the Health and Social Care Act 2022, Schedule 4 part 2, – 2(1)); Other defined designated bodies are: a Health and Social Care Trust; a relevant independent hospital and the headquarters in Northern Ireland of regular or reserve forces.

Designated bodies must notify the details of their CDAO and any subsequent changes to DoH who will maintain the list of the CDAOs including relevant contact details, which can be found at:

Guidance on the safe management and use of controlled drugs | Department of Health (health-ni.gov.uk)

All organisations within the region are required to report CD incidents and concerns to their CDAO.

Frequently Asked Questions

Q1. Why were CDAOs appointed?

The CDAO legislation was introduced in response to the Shipman Inquiry Third Report - July 2003 in order to strengthen the governance arrangements around CDs. The CDAO Regulations require each designated body, to appoint a CDAO who has overall responsibility for the safe management and use of CDs.

Q2. What is the LIN and what does it do?

The LIN membership is constituted with CDAOs nominated from their Designated Body from across Northern Ireland. Each CDAO is required to share concerns regarding CD management with the LIN.
Representatives from Responsible Bodies as defined in The CDAO Regulations also attend LIN, where complementary good quality information and concerns about the management of CDs is shared in a secure and timely manner in accordance with an agreed LIN inter-agency Information Sharing Protocol. Responsible bodies are defined in the CDAO legislation as: a Designated Body; the DoH; Regulation and Quality Improvement Agency (RQIA); Regional Business Services Organisation (RBSO); the Police Service of Northern Ireland (PSNI); a Regulatory Body.
Quarterly Occurrence Reports are submitted to the DoH CDAO by the designated bodies’ CDAOs and these contain concerns regarding the management or use of CDs; or confirmation that there are no concerns to report. Representatives of each of the other responsible bodies provide updates about their activities at the quarterly LIN meetings.

Q3. What specific responsibilities does a CDAO have?

Ensure CD Standard Operating Procedures (SOPs) are in place in each area of the organisation e.g. all GP practices. SOPs must include legal and best practice procedures for:	Ensure best practice in relation to the management and use of CDs. This includes arrangements for:
Storage of, and access to, CD	Monitoring, and alerting the CDAO of concerns
Security of CD	Managing untoward incidents
Disposal and destruction of CD	Maintaining records of, and managing, concerns
Who is to be alerted if complications arise	Sharing information - a quarterly incident report must be submitted by each CDAO to the chair of the LIN -including a NIL report
Record keeping including patient returns	Ensuring required training is received.
Prescribing, supply, administration
Clinical monitoring of CD.

Q5. How do I contact the CDAO for primary care?

The DoH CDAO may be contacted by email at ControlledDrugsAccountableOfficer@health-ni.gov.uk

Further guidance on the role of the CDAO, and the Safe Management of CDs in Primary Care, can be found at: https://online.hscni.net/our-work/pharmacy-and-medicines-management/controlled-drugs/

Links to CDAO legislation as referenced above :

Links to other relevant legislation can be found at : Controlled Drugs - DOH/HSCNI Strategic Planning and Performance Group (SPPG)

Link to relevant National Institute for Health and Care Excellence (NICE) guideline NG 46, Controlled Drugs: Safe Use and Management, which has not undergone a formal Northern Ireland endorsement process however, as a National Guideline is considered good practice. NG46 Controlled drugs: safe use and management full guideline (nice.org.uk)

Privacy Notice

Following the closure of the HSCB on 31st March 2022 and a transfer of its functions to DoH, responsibility for the CDAO role also transferred to DoH.

The Department is committed to protecting your privacy when you use our services, as set out in the Privacy Notice.

Information Letters

Chief Medical Officer letter about the transfer of the CDAO role to the DoH following the closure of the Health and Social Care Board, issued 31 March 2022.

Reporting Health Fraud

To report a suspicion of fraud call the HSC Fraud Hotline on 0800 069 33 69 or report online.

More information on Counter Fraud Services can be found at the Counter Fraud and Probity Services website.

Cascade Alerts – sharing personal and sensitive information

Incidents of significant concern locally e.g. patients or healthcare professionals fraudulently obtaining Controlled Drugs, prescriptions, patient alerts which would need to be shared by the BSO Counter Fraud Service through a cascade alert with healthcare professionals including GP Practices, Dental Practices, Hospitals, Community Pharmacies and other relevant healthcare providers. These alerts may contain sensitive personal information to help prevent further fraudulent activity and prevent harm to the public.

Personal sensitive information shared on alerts is usually provided to the BSO Counter Fraud Service by the police and other healthcare professionals who request us to send out an alert on a local standard template. BSO Counter Fraud Service facilitate this process and on some occasions, this information may only be alleged concerns.