The Controlled Drugs (Supervision of Management and Use (Amendment) Regulations (Northern Ireland)

2015

The Accountable Officers’ Report

1 April 2015 – 31 March 2016

November 2016

Contents

Page

2 Introduction

3 Accountable Officers

6 Local Intelligence Network

9 Updates from Accountable Officers and Responsible Bodies

9 (1) Health & Social Care Board

13 (2) Health & Social Care Trusts

16 (3) Northern Ireland Ambulance Service

17 (4) Hospices

17 (5) Independent Hospitals

20 (6) The Department of Health

22 (7) The Regulation and Quality Improvement Authority

23 Appendix 1 - Controlled Drugs Dispensed in NI: 2011 – 2015

23 Appendix 2 - Charts 1 - 7 – range Primary Care Prescribing Data

28 Appendix 3: Background to the introduction of The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 and the Controlled Drugs (Supervision of Management and

Use) (Amendment) Regulations (Northern Ireland) 2015

33 Appendix 4: Meeting Attendance

Introduction

This is the sixth report of the Accountable Officers in Northern Ireland concerning the governance of controlled drugs and the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 20091 (“the Regulations”) which were updated in year by the Controlled Drugs (Supervision of Management and Use (Amendments) Regulations (Northern Ireland) 2015².

The report is written to record, inform, and provide assurances to patients and the public, Designated and Responsible Bodies, healthcare professionals and other stakeholders of the progress made between 1 April 2015 and 31 March 2016. It highlights some key developments during this period and reflects on prescribing patterns for a range of controlled drugs (CDs).

While the report provides an overview of the Northern Ireland situation, it also recognises the position of Accountable Officers and does not detract from their accountability to their own Designated Bodies or indeed the totality of assurances that they would be expected to give over the extent of the legislation. Accountable Officers are answerable to the senior management within their own organisation for implementing the requirements arising out of the Regulations. This report, in conjunction with each organisation’s own internal reporting mechanisms, will support

1http://www.legislation.gov.uk/nisr/2009/225/pdfs/nisr_20090225_en.pdf ²http://www.legislation.gov.uk/nisr/2015?title=The%20Controlled%20Drugs%28Supervision%20of%20Management%20and%20USe%29%20%28Amendment%29%20Regulations%20%28Northern%20Ireland%29%20

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Accountable Officers in providing the necessary assurances to their senior management team or Board.

Accountable Officers

There were 20 Designated Bodies and 20 Accountable Officers in Northern Ireland between 1 April 2015 and 31 March 2016.

Figure 1

The Department of Health continues to maintain the list of Accountable Officers. An up-to-date contact list can be found on the Accountable Officer section within the Department’s website and accessed through the following link: https://www.health-ni.gov.uk/sites/default/files/publications/dhssps/accountable-officer-contact-list.pdf

Each Designated Body is responsible for informing the Department of the removal and appointment of an Accountable Officer. Between 1 April 2015 and 31 March 2016, one Designated Body made a change to its nominated Accountable Officer.

Following the amended Regulations coming into operation in 2015, three additional Designated Bodies joined the LIN: GCRM, Origin Fertility Clinic and the Ministry of Defence. The Amended Regulations also brought the Northern Ireland Social Care Council, the regulatory body for Social Care, within the range of Regulatory Bodies that are designated in the LIN.

Introduction of the 2015 Amended Regulations to the Controlled Drugs (Supervision Of Management and Use) Regulations (Northern Ireland) 2009

With the Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 which were enabled in July 2015, additional requirements were specified for Accountable Officers as well as specification that the responsibility for the LIN became the responsibility of the HSCB’s Accountable Officer. The Regulations saw a broadening of the scope of Responsible Bodies that are required to nominate an Accountable Officer.

In responding to the legislation there are essentially four core elements of work:

- Monitoring the use of controlled drugs and making timely and effective interventions when necessary

- Developing and implementing robust processes for the use of controlled drugs

- Assessing the robustness of systems through self-assessment, inspections and audit

- Identifying and sharing concerns through the Local Intelligence Network (LIN)

The Amended Regulations (2015) require procedures to now include best practice relating to:

- The prescribing, supply and administration of controlled drugs

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Accountable Officers by Profession

11 Nurses6 Pharmacists1 Medical Practitioner1 Radiographer1 Brigadier

- Clinical monitoring of patients who have been prescribed controlled drugs

Transfer of Operational Responsibility for the Local Intelligence Network

On 1 December 2014 responsibility for the Local Intelligence Network (LIN) was transferred from the Department to the Accountable Officer for the HSC Board.

This mirrors arrangements in England, Scotland and Wales. The Department and the Board have worked collaboratively to ensure a seamless transition.

The amended Regulations (2015) enshrine the Accountable Officer of the HSC Board as the lead Accountable Officer in Northern Ireland with operational responsibility for the LIN.

Work continued during 2015 to review both content and ownership of the Accountable Officer website. The website, currently maintained by the Department, does and will continue to manage the list of Accountable Officers in Northern Ireland. https://www.health-ni.gov.uk/sites/default/files/publications/dhssps/accountable-officer-contact-list.pdf

The Department continues to liaise with the Board to consider the on-going provision of training materials and other LIN related documents.

Database

As a result of the decision to transfer operational responsibility for the LIN from the Department to the Board, responsibility for the development of the database was likewise transferred.

The Board continued to make progress with the development of the new system in 2015-16. This included the development of training materials and a user guide and system set up and testing with each organisation. Following an internal testing period and training for each Accountable Officer and organisational representative, the database is expected to ‘go live’ in late 2016.

National and Cross Border Meetings

National Group

The National Group meets quarterly and is a strategic group of regulators and key agencies that have areas of responsibility for controlled drugs within their remit. The meetings are hosted by the Care Quality Commission and the Department has been granted permission to attend the meetings as an observer. Being present as an observer enables Northern Ireland to keep abreast of matters relating to controlled drugs elsewhere.

The Cross Border Group for safer Management of Controlled Drugs in the Devolved Administrations

The Cross Border Group is also hosted by the Care Quality Commission and meets twice yearly. Representatives include England, Scotland, Wales, Republic of Ireland, Northern Ireland, Isle of Man, Jersey and Guernsey. The Department, RQIA and the Pharmaceutical Society of Northern Ireland represent the interests of Northern Ireland. Like the National Group, the Cross Border Group receive updates from the various countries represented to ensure that all parties keep abreast of important updates relating to controlled drugs and allows best practice to be shared and implemented where appropriate.

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The aims of the Cross Border Group are to:

a) Provide a forum to promote the sharing of general controlled drugs concerns (rather than specific issues or named individuals) across national borders

b) Share learning and best practice methodologies that support the safer management of controlled drugs in each nation

c) Share analysis of trends and associated risks pertinent to safer

management and use of controlled drugs.

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20Designated

Bodies

1 Local Intelligence Network

20 AccountableOfficers

LOCAL INTELLIGENCE NETWORK (LIN)

1 April 2015 - 31 March 2016

Figure 2 MEETING ATTENDANCE

See Appendix 4 for the attendance record for individual Responsible Bodies

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Organisations are required to make and to keep records of controlled drug incidents. The Accountable Officer must then ensure that any such incidents are fully and properly investigated and that those which raise concerns about any relevant person such as a healthcare professional are recorded on an Occurrence Report.Legislation requires that every Accountable Officer submits a quarterly Occurrence Report to the Chair of the Local Intelligence Network. Submission of Occurrence Reports is aligned to scheduled LIN meetings. During the period 1 April 2015 and 31 March 2016 every Accountable Officer submitted an Occurrence Report in each quarter. An Accountable Officer must submit an Occurrence Report even if there are no concerns to report and the Occurrence Reports are categorised as follows:

Nil return: No concerns reported

Concerns: The Accountable Officer has reported a concern(s)

The Occurrence Report template also includes sections for the Accountable Officer to record:

Learning Points arising from an occurrence

Updates on previous occurrences

During the period 1 April 2015 – 31 March 2016, of the 72 Occurrence Reports received 28 had concerns recorded.It is important to note that not all the concerns reported raise issues about relevant person(s).

Each Accountable Officer determines which CD issues are to be reported on their quarterly Occurrence Report.

Accountable Officers will often use the Occurrence Report and the opportunity of discussion within the LIN to highlight identified system weakness for example and to share their learning.

The Occurrence Report includes a section specifically for learning points and Accountable Officers are asked to identify potential learning from their incidents and concerns. This could include, for example, changes to practice or protocols which have been introduced by the reporting organisation to strengthen their arrangements.

Learning points are shared and discussed within the LIN. Organisations can therefore learn both about a concern and, wherever possible, learn from these concerns. This supports Accountable Officers, and indeed other Responsible Bodies, deliver continual improvements in relation to the management and use of controlled drugs.

While the majority of learning points have particular relevance to the originating organisation alone, many have application to other Responsible Bodies within the LIN. In addition there are a small number which the LIN considers should be shared

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OCCURRENCE REPORTS

CONCERNS

LEARNING POINTS

more widely. These regional learning points are sent to the Chair of the Medicines Safety Sub-Group for consideration by the Group and dissemination as appropriate.

The HSC Board has used its Medicines Safety newsletters to raise the awareness of health care professionals to CD concerns an example of which can be found through the link below: http://www.medicinesgovernance.hscni.net/

primary-care/newsletters/medicinessafety-matters-prescribers-community-pharmacists/

Figure 3

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OCCURRENCE REPORTS BY TYPE

1 Health and Social Care Board (HSCB)

Secure the Safe Management and Use of Controlled Drugs

The scope of Controlled Drugs that falls under the remit of HSCB is significant as it covers the entirety of Primary Care. By way of example, Appendix 1 sets out the volume of prescriptions and dosages dispensed in Primary Care in Northern Ireland.

Work continues in the HSCB to secure the safe management and use of controlled drugs by doctors, dentists and pharmacists as outlined below.

GPs

Work is still ongoing to increase capacity in order to put in place an inspection schedule which will result in CD inspection visits to practices over a five year rolling programme of visits, to cover all GP practices. This will build on the information gathered during the self-declaration and assessment process, and provide an opportunity to follow-up on any issues identified from that process and any other concerns that may have arisen in the interim.

CD inspection visits to GP practices have been carried out by HSCB staff on a number of occasions during 2015 in response to potential concerns identified as part of routine CD monitoring or adverse incidents reported to the Board. Action plans were developed and reviewed as necessary following the visits.

The CD inspection process and associated resources have been reviewed and updated following feedback from visits carried out to date. Further, staff have also been trained in the inspection process.

HSCB guidance around the safe management and use of CDs continues to be promoted to GPs, with key messages being reinforced both regionally and locally as opportunities arise. HSCB Guidance for Developing a CD SOP is in the process of being updated to include guidance on frequently asked questions and recent legislative changes.

Community PharmacistsA declaration and self-assessment form was sent to all community pharmacies in February 2015 and this form is subject to review by the Medicines Regulatory Group (MRG). A Memorandum of Understanding has been put in place between MRG and HSCB which sets out organisational and partnership arrangements with respect to monitoring contracted community pharmacies in terms of their legislative requirements pertaining to controlled drugs. The working arrangements between the MRG and HSCB is characterised by regular contact and the exchange of information (subject to all regulatory requirements).

DentistsA Controlled Drugs Self Declaration has been received in 2014 from each dental practice as part of their annual Quality Assurance return. This declaration relates to their handling and management of CDs, as required by the Accountable Officer regulations. The Quality Assurance form also now includes a piece which allows for ready identification of dentists who are providing conscious sedation to facilitate development of any further monitoring that is required in this area.

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UPDATES PROVIDED BY ACCOUNTABLE OFFICERS AND OTHER RESPONSIBLE BODIES

Management of CDs in the Community

One of the areas of risk in the management of CDs in the community is when they are stored in the patient’s home for individual patient use, but are then administered to the patient by nursing staff. A number of incidents have been reported to HSCB and Trusts where CD ampoules or patches appear to have gone missing between nursing shifts, but current recording systems do not lend themselves readily to verification of this data. A regional piece of work was carried out during 2013 and 2014 to develop a Controlled Drug Record Card (CDRC) and supporting guidance and patient information. The CDRC is intended to be used by nursing staff from all organisations to record stock received by, and administered to, patients and will go some way to protecting and providing assurances to nursing staff. The documents have been finalised by the Local Intelligence Network (LIN) and are now going through the Trust Drugs and Therapeutics committees to agree implementation.

Adequate Destruction and Disposal Arrangements for Controlled Drugs

General Medical and Dental practices are advised to return unwanted and out of date controlled drugs to a community pharmacy for destruction. GPs have been advised to include a section on this in their SOP for the safe management of CDs.

Monitoring and Auditing of the Management and Use of Controlled Drugs GPs and Non Medical Prescribers

HSCB pharmacists continue to undertake quarterly monitoring of all HSC

prescriptions for controlled drugs (both patient prescriptions and stock orders) and follow up with prescribers where appropriate. All concerns are recorded on a database and discussion of these is encouraged at local team meetings and with the AO as necessary. An SOP has been developed for the regular monitoring of all privately ordered controlled drugs (for both private stock requisitions and PCD1 prescription forms). Scans of all private stock requisitions and PCD1 forms are sent to relevant Board staff from the BSO for review and follow-up as needed. The process for monitoring private prescribing of CDs is currently being updated following a review of the existing process.

A process has also been established for the ordering of PCD1 forms, to ensure that these are only ordered where there is an identified need and when there are no concerns about the prescriber. Information on the ordering process for PCD1 forms has been sent to all GPs, dentists and community pharmacists and posted on the three practitioner sections of the BSO website/intranet.

DentistsControlled drug prescribing is monitored on a monthly basis by a Dental Adviser with support from a Pharmacy Adviser. The Standard Operating Procedure (SOP) for this monitoring has been updated in conjunction with the Accountable Officer to support the work.

Community PharmacistsMonitoring is undertaken by the DoH on behalf of the HSCB. Following a concern in relation to alleged diversion of Schedules 3, 4 and 5 Controlled Drugs, a project is currently being undertaken which will test whether routine reconciliation of wholesale records against dispensing claims will strengthen the security of the supply chain.

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Monitoring of community pharmacists is undertaken by DoH on behalf of the HSCB and over the years close collaboration has developed. The lawful supply route is a CD requisitioned by a community pharmacy from a pharmaceutical wholesaler. A CD is dispensed from a community pharmacy against a prescription from a patient or a stock requisition by either a dentist or a doctor. Weaknesses in the lawful supply route have been identified through a number of serious adverse incidents (SAIs). The CD Reconciliation Project (CDRP) was established to assure the security of the supply chain. A method of reconciliation was therefore developed between ‘supplies in’ and ‘dispensing from’ pharmacies. It was anticipated that CDRP would identify further alleged diversion and through engagement with pharmacists would service as a deterrent. CD data were sourced from the main pharmaceutical wholesalers to the 534 pharmacies in NI. As a measure of the complexity, for the period October 2014 -October 2015 there are 1.4 million rows of data providing details on 4.1 million CD items supplied in NI. The database was constructed over a year and required expert IT, statistical and pharmaceutical expertise. CDRP has enhanced security of the supply chain and left a legacy of effective collaboration between IT, statisticians, investigators, community pharmacy representatives and pharmaceutical wholesalers, entirely unique across the UK. A number of investigations have been conducted and the process continues to highlight issues which are actively addressed.

Relevant Individuals Receive Appropriate Training

Training continues to be provided to a range of staff on issues relating to CDs. During 2015-16, the following training was carried out:

Frequently Asked Questions (FAQs) bulletin on the Roles and

Responsibilities of the Accountable Officer was issued to GPs, community pharmacists and dentists

Training on safe dispensing of CDs was delivered to final year pharmacy students as part of High Risk Medicines training

Learning from incidents involving CDs is included in newsletters to GPs and CPs on an ongoing basis as required

Practice specific training and guidance on CD related issues, such as SOPs, is provided on an ongoing basis as needed to GPs and their staff – e.g. in follow up to a CD inspection or adverse incident

The annual dental prescribing newsletter has included articles on various aspects relating to CDs. These publications are sent to all dental practitioners in Northern Ireland and are posted on the dental section of the BSO website

Any Dental Practitioner applying to be on the dental list in Northern Ireland has to attend a “New Starts” information presentation. This includes information on the prescribing of CDs. All new dental graduates who are Vocational Trainees also receive this presentation in the first month of their vocational training year.

Maintain a Record of Concerns Regarding Relevant Individuals

A database continues to be maintained to allow all CD monitoring and auditing by HSCB pharmacists to be recorded. Additionally, the Accountable Officer keeps a database where all controlled drug concerns and their status are recorded. All prescribing, dispensing and administration errors/concerns that relate to CDs are recorded and managed as adverse incidents by HSCB Pharmacy Advisers where necessary. This is to ensure learning and/or more serious

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concerns are identified and shared as appropriate.

Processes have been put in place for HSCB to work more closely with staff in BSO Counter Fraud and Probity Services around identification of potential fraudulent activity, particularly as it relates to CDs, and to ensure that there are systems in place in general practice and community pharmacy to reduce the risks associated with this.

Assess and Investigate Concerns

After the AO has been advised, any concerns are investigated locally in the first instance by the HSCB pharmacist with support from other Board staff, such as the Medicines Governance Adviser and Medical Adviser, as required (annex 1). Some eighty seven errors/concerns were reported in 2015 compared with sixty eight in 2013 and sixty in 2012. Those that breach the agreed threshold level are reported to the Northern Ireland Local Intelligence Network (LIN).

All concerns are followed up and an action plan is developed where necessary. If the concern is not resolved the Accountable Officer will, either solely or in partnership with other agencies, investigate or prepare a file for referral to the appropriate regulatory body.

Take Appropriate Action If There Are Well Founded Concerns

Action has been taken where appropriate with individual practitioners. Any local or regional learning from these has been identified and shared.

Establish Arrangements for Sharing Information

Each of the organisations’ Accountable Officers (AO), as well as regulatory

bodies, meets as part of the NI LIN. The group meets quarterly to share information about potential CD offences and potential or actual systems failures. In December 2014, the HSCB took over the responsibility for the LIN, with the chairmanship passing from the DoH to Mr Joe Brogan, who is the HSCB’s AO. As part of this arrangement, HSCB continues to review the data and information governance arrangements of the LIN to minimise the risks to the Board:

The HSCB is now responsible for centrally co-ordinating all the Occurrence Reports that are received from member organisations, and sharing these as appropriate. The current infrastructure relies heavily on paper based mechanisms which are slow and administratively burdensome, and consequently funding was secured to develop a secure database to replace the paper based system. Work is almost complete in developing this electronic secure records management system and database which will ensure the effective operational management of the LIN. This is expected to go live in late 2016.

A revised Information Sharing Agreement for all organisations involved in the LIN was drafted and approved by LIN members. However, it is in the process of being updated to reflect the Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations NI (2015) which came into operation on 15 July 2015. It will be sent to all member organisations in the near future.

The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations NI

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(2015) have been reviewed by LIN member organisations to identify outstanding actions to meet legislation requirements. In response to this, a paper was developed outlining the requirements for Clinical Monitoring of CDs. Member organisations have been asked to ensure that they have appropriate procedures in place to reflect legal requirements.

Further details of the LIN membership and arrangements for sharing information are available at https://www.health-ni.gov.uk/publications/guidance-safe-management-and-use-controlled-drugs

The Health and Social Care Board can provide extensive monitoring information on the use of controlled drugs in primary care and this information has also been shared within the LIN to help inform risk management arrangements

2. Health and Social Care Trusts

There are 6 Health and Social Care (HSC) Trusts in Northern Ireland. Five of these are acute and community HSC Trusts and the sixth is the Northern Ireland Ambulance Service.

HSC Trusts (Acute and Community)The 5 HSC (acute and community) Trusts in Northern Ireland are:

Belfast HSC Trust Clinical monitoring of patients

prescribed controlled drugs

The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015

included an amendment of regulation 9. BHSCT have developed a policy and standard operating procedure on clinical monitoring of patients who have been prescribed controlled drugs.

BHSCT Controlled Drug Stationery

In 2015-16 changes were made to enhance the security of controlled drug stationery. Controlled Drug Schedule 2 and Schedule 3 order books record the date of issue and the name of the issuer on the front cover to minimise risk of diversion of controlled stationery. BHSCT’s controlled drug prescription pad was redesigned in a quadruplicate form and also incorporated a record of the date of issue and the name of the issuer on the front cover.

Controlled Drug Incidents

The BHSCT Accountable Officer is notified of all controlled drug incidents reported on the Trust Datix system.

Controlled Drug Audits and Compliance

There are currently 207 wards/departments within BHSCT in-patient areas subject to a quarterly controlled drug audit. The audit comprises of 13 standards and assesses compliance with legislative and governance requirements. Each ward / department must meet each standard fully to be deemed compliant. CD audit results are collated by Trust, Directorate and Co-Director areas and disseminated to Directors and Co-Directors for review.

Controlled Drug Monitoring

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Monitoring of all schedules of controlled drug usage is ongoing; this includes spot checks on ordering and receipts of Schedule 4 and 5 controlled drugs. 10% of wards were subject to Schedule 4 and 5 spot checks in 2015-16.

Victoria Pharmaceuticals

In 2015-16 an internal review of the management and supply of controlled drugs by Victoria Pharmaceuticals to the Northern Ireland Ambulance Service was undertaken. A number of recommendations were made and standard operating procedures have been reviewed and updated locally.

Northern HSC TrustThere were no DoH Medicines Regulatory Group inspectorate visits this year to the Trust facilities. Self-assessments were carried out for each site and were satisfactory.

Update on Action Plan for RQIA Review of the Management of Controlled Drug Use in the Trust

Work continues to address the recommendations made by RQIA as follows:

1. There is still not a Designated Officer to support the AO and this remains on the Directorate Risk Register.

2. In relation to the monitoring of controlled drugs usage, further improvements have been made in respect of the JAC pharmacy computer system by the Regional System Administrator which will facilitate monitoring. In addition, a second job role within the technical staff team includes enhanced

monitoring of controlled drugs and drugs liable to abuse. Further, the HSCB has sourced a new data capture and reconciliation tool and this is being looked at in terms of translation into the secondary section.

3. Policy on drug diversion (misappropriation) is going to be developed by the Medicines Governance Committee during 2016-17.

4. A programme of unannounced visits is on-going to ensure that all aspects of controlled drugs are in line with best practice.

5. No progress has been made in relation to the appointment of a new pharmacist with a role in medical staff education (which would include controlled drugs) and this will be pursued in 2016-17.

6. Further work is on-going to ensure an adequate pharmacy service on all wards i.e. operating a comprehensive one-stop dispensing system

7. In relation to acute lists of authorised signatures for controlled drugs, the dispensary keeps a list of signatures of nursing staff and a similar list for doctors is available from Medical Education

8. A regional document in relation to the sharing of names is at final checking

LIN (Local Intelligence Network)

The Accountable Officer (AO) attended all four meetings of the LIN held during 2015-16. In relation to the Occurrence Reports for the year, a total of four concerns were raised and two updates on earlier concerns were provided.

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Key Work of the LIN In 2015-16

1. Guide for Disclosing Identity Details of Relevant Persons – it is hoped that this final version will be approved in mid-2016-17

2. Work is progressing to install an electronic database for recording concerns, updates etc

3. In order to facilitate the operation of the new database, a Management and Sharing Concerns - threshold criteria was developed

4. The group also contributed to the review of the Controlled Drugs (Suspension of Management and Use) Regulation 2013

Southern HSC TrustA number of initiatives relating to Controlled Drugs were progressed during 2015-16:

RQIA Action PlanThe Trust action plan to address the 15 recommendations from the RQIA Independent Review of the Management of Controlled Drug Use in Trust Hospitals (June 2013) was updated. By 31st March 2016, ten of the recommendations were fully implemented, one is in progress and the four remaining are dependent on additional staffing resources becoming available for completion.

Controlled Drug Standard Operating Procedures

Trust standard operating procedures (SOPs) for the management of controlled drugs at ward/department level were reviewed and updated in October 2015. This review was carried out by Pharmacy and Nursing staff,

taking into account the learning from recent incidents.

Visit by the DoH’s Medicines Inspector

Mr Tony Wallace, Pharmaceutical Officer from the DoH’s Medicines Regulatory Group visited the Trust’s two Pharmacy Departments (Craigavon Area Hospital and Daisy Hill Hospital) in April 2015. His key recommendations included further updates for standard operating procedures and ensuring that pharmacy staff have been trained on the updated SOPs.

Liaison With Other OfficersThe AO has worked closely with the Trust’s Responsible Officer and other Accountable Officers during the year with respect to the safe management of controlled drugs and investigations of concerns.

South Eastern HSC TrustIn the South Eastern Trust, a number of initiatives relating to CDs were progressed during 2015-16:

Action points from the Medicines Regulatory Review Inspection were implemented across the 3 sites.

Ward and Theatre updated to include the amendments to the Misuse of Drugs Regulations (Northern Ireland) 2002 from 1st March 2016 (Ketamine moved to Schedule 2).  The handwriting requirement for temazepam was already policy within SEHSCT.

The Trust’s medicines policy was amended to clarify the position for Dental Core Trainees (DCT) Prescribing Controlled Drugs.

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Introduction of clear tamper evidence bags for the safe storage of patients own controlled drugs following a number of incidents.

Benzodiazepine policy for Prison Health care was updated

Audit of staff ordering ward stock of Schedule 2 controlled drugs  from pharmacy against ward authorisation list – 65% compliance and a number of  lists had  not been updated in the last 12 months.

Continue to work with governance facilitators to improve compliance with the recording of CD administration. 

Western HSC TrustThe Western Trust undertook the following activity in year in relation to CD management:

Guidance for the management of parenteral and transdermal controlled drugs in primary care was ratified by Trust D&T and over 20 training sessions were run for district nursing staff.

Pharmacy CD Standard Operating Procedures were updated and training underway.

The Trust has gone at risk to provide funding for 1wte band 8a Pharmacist to support the Accountable Officer as required by legislation

The Trust’s AO continues to work closely with the ADs Nursing Governance and HR with respect to safe and secure management of controlled drugs.

3. Northern Ireland Ambulance Service HSC Trust

NIAS paramedics have had access to morphine for 5 years which has significantly improved the management of patients with severe pain following trauma and medical complaints such as acute myocardial infarction. The procedures for the acquisition, storage, possession and administration of this and also intravenous diazepam are tightly regulated via the NIAS Medicines Policy and Procedure which was reviewed in 2015.

Medicines Management was subject to audit under Controls Assurance in February 2016 where NIAST’s current practice was found to be substantially compliant with the requirements of the inspection team.

In addition, all NIAS facilities where drugs are stored are subject to inspections by MRG officers who review the records kept at both station level and by individual staff. No significant issues have been identified in the past year and the procedures in place allow for the tracking of individual doses of morphine through NIAS systems. This allows rapid investigation of potential discrepancies but to date any of these have been shown to be the result of individual administrative errors rather than the physical loss of drugs.

NIAS has recently introduced an emergency stockpile of drugs for rapid deployment in the event of a declared major incident. This is held centrally and contains stocks of drug packs, including morphine, sufficient to provide crews attending a mass casualty situation with the increased resources necessary.

4. Hospices (Independent Hospitals)

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All 4 adult Hospices in Northern Ireland, Marie Curie Community Nursing Services along with the Northern Ireland Children’s Hospice have Accountable Officers.All areas have robust SOPs in place and undertake regular audits around controlled drugs as well as self-assessment for the Accountable Officers using the ‘Help the Hospice’ audit tool.

Significant issues or concerns reported to LIN through the Occurrence Reporting system generate learning points and once actioned the LIN is updated.

Learning points generated this year are as follows:

- Northern Ireland Hospice = 1 (revised method of storing and recording of patients’ TTO Controlled Drugs for discharge).

- Northern Ireland Children’s Hospice = 0

- Foyle Hospice = 0- Marie Curie = 0- Marie Curie Community Services =

0- Southern Area Hospice = 0

All of the Hospices listed have undergone inspection in relation to CDs by the DoH in 2015-16 with satisfactory outcomes being achieved for each and any action points raised have been implemented.

A rolling programme of education around regulation and the management of controlled drugs continues across all the Hospices.

The Hospices value the LIN network and the arena created to discuss issues and share best practice. Particular reference should be made to the very informative presentation delivered by the PSNI representative. As palliative care encounters an increase in patients using illegal drugs, the wider context was a really valuable enhancement in knowledge.

5. Independent Hospitals (other than Hospices)

a. Hillsborough Private Clinic

Hillsborough Private Clinic is an Independent Hospital which is regulated by the RQIA.

The Clinic holds a small stock of Controlled Drugs - only one locked cupboard.

All staff have had their yearly Medicine Management Training which has included Controlled Drugs. 

The CD SOP was amended to include the July 2015 requirement for best practice relating to the prescribing, supply and administration of CDs.  During the year staff have been trained on the updated SOP. The clinic has been preparing technology to commence remote access to the new LIN Database and this is now in place.

This year CD checks have been increased to daily on the advice of RQIA pharmacy inspectors.  As there may be only 1staff nurse on duty in the clinic if theatre is not in use, administration staff have been trained to check CDs with the Nurse in Charge to provide a second signatory. Following advice from the Pharmaceutical Officer, the CD order form has been enhanced to meet requirements in the Misuse of Drugs Regulations.  The form is temporary until a standardised controlled drug requisition form becomes available for NI..

b. Fitzwilliam ClinicFitzwilliam Clinic is an independent hospital regulated by RQIA. Fitzwilliam Clinic does not have in-patient bed facilities therefore all procedures are done

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as day cases. There is just one theatre so the Clinic requires minimal range of stock and drugs. It does not have an on-site pharmacy so there is an agreement with AAH Pharmaceuticals Ltd to obtain CDs. Doctors are self-employed and must adhere to the Clinic’s strict practising privileges.

There is a small team of five nursing staff and when required the Clinic’s bank system is used. All staff receive Medicine Management Training.

To date, there have been no occurrences to report.

Participation in the LIN meetings enables the Independent Sector to remain updated and also allows the Clinic to share concerns and promote learning.

c. Ulster Independent ClinicAttendance at the quarterly LIN meetings has again been useful to us in the Independent sector, as the knowledge gained enhances our practice regarding controlled drugs.

This year we have had controlled drug inspections by the local inspector at the Department of Health, Medicines Regulatory Group, and also by RQIA.

Other inspections of Controlled Drug stock include twice daily checks in the clinical areas, as well as statutory quarterly inspections by the pharmacist in each department.

Pharmacy CD stock is audited formally each month, at every stock transaction and at least annually by the Accountable Officer.

Following any drug incident with CDs, the staff involved undergo a short CD policy review session with the Pharmacist to refresh policy and practice in the correct use of CDs.

The Clinic continues to review its SOPs regarding Controlled Drugs, often encompassing issues learned from the LIN to improve its practice and ultimately contribute to the safeguarding of its patients.

d. North West Independent Hospital

The North West Independent Hospital is registered and regulated by the RQIA. Until October 2015, the Hospital Director of The North West Independent Hospital had held the position of Accountable Officer. This position has now been delegated to the Clinical Governance Officer who also attends the quarterly LIN meetings and completes the quarterly Occurrence Reports.

From July 2016 all incidents, concerns and quarterly Occurrence Reports will be reported online and to facilitate this, LIN provided training during the first few months of 2016 which the North West Independent Hospital’s Accountable Officer attended and where she had an opportunity to try out the proposed new system. The Accountable Officer continues to carry out quarterly checks in all departments e.g. Theatre, Surgical Wards and Pharmacy ensuring all Controlled Drugs registers, order books and receipt books are completed in full.

Through audit with the pharmacist the Accountable Officer also ensures there is a clear unbroken pathway for all Controlled Drugs received, used and disposed of in the hospital.

Developments for 2016 include the introduction of monthly audits by the pharmacist in every Department with the Accountable Officer carrying out quarterly audits using the CQC Controlled Drug audit tool.

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The Accountable Officer will also aim to attend at least 1 staff meeting in each department every quarter to outline her role and any occurrences or near misses and subsequent learning.

All staff involved in administering medication have to undergo medication training every three years and competency assessment on a yearly basis. The competency assessment tool was reviewed by the Accountable Officer and a ward manager in 2015 to expand various areas including management of controlled drugs where the role of Accountable Officer and clinical monitoring of patients was considered essential elements in the tool.

The North West Independent Hospital’s policies and procedures in controlling the use of Controlled Drugs are reviewed by the Accountable Officer and pharmacist every two years or sooner if required to meet any changes in legislation or guidelines. In addition to intranet format all policies are held in hard copy in each Department.

There have been no occurrences or near misses during the year 2015-2016This is due mainly to robust audit, staff education and stringent compliance within the Controlled Drugs Standard Operating Procedures and departmental polices.

As the North West Independent Hospital is one entity it is much easier to manage and coordinate the use of Controlled Drugs.

Controlled Drugs are not dispensed to patients on discharge.

e. Kingsbridge Private Hospital

Kingsbridge Private Hospital (KPH) is an independent hospital regulated by RQIA.

KPH does not have a pharmacy but is supplied by a wholesale / community pharmacy.In April 2015 a new Accountable Officer (AO) was appointed in Kingsbridge Private Hospital, the AO is also the Governance Manager.

During the period 1 April 2015 and 31 March 2016 the AO or deputy attended the LIN meetings and submitted an Occurrence Report in each quarter with 3 nil returns and 1 concern investigated locally and additional staff training put in place.

The AO is notified of all controlled drug incidents reported via an electronic risk management event form. A CD inspection visit was made to Kingsbridge Private Hospital in June 2016 by the Medicines Regulatory Group and two action points have been addressed.

Controlled drug check audits are carried out in all areas quarterly by the external supplying pharmacy and a controlled drug self-assessment relating to the handling and management of CDs was carried out in all areas by the new AO. Some changes to practice following this include strengthening staff training processes.A process for monitoring the usage of all schedules of controlled drugs is in place within the hospital.

The SOP has been reviewed and updated to reflect the amendments to the Controlled Drugs Regulations (NI). This included changes to patient clinical monitoring and additional mandatory staff training every two years is currently being implemented.

A collaborative process has been established with Joe Brogan and the AO in KPH in relation to PCD1 form monitoring and a process has recently been established for the auditing of PCD1 forms at Kingsbridge Private Hospital.

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f. GCRM

GCRM-BELFAST is a licenced fertility clinic which opened for treatments in January 2014. The clinic is regulated by both the Regulation and Quality Improvement Authority (RQIA) and the Human Fertilisation and Embryology Authority (HFEA).

It holds a small supply of controlled drugs for the sedation of patients undergoing day procedure. These are sourced from a local wholesaler who delivers directly to the clinic.

GCRM-BELFAST has been inspected on 1st June 2015 by a representative from the DoH Medicines Regulatory Group. No incidents were identified and two defects have been addressed. A more recent Medicines Management inspection on 3rd February 2016 by the RQIA identified no requirements or recommendations.

The Accountable Officer is the Clinic Manager who is also the Lead Nurse. She values the LIN contact as a useful support to help maintain good practice in relation to the management of controlled drugs within the clinic.

To date there have been no concerns or occurrences in GCRM-BELFAST which required to be reported and with robust SOPs and audit we strive to ensure this continues.

g. Origin Fertility Care

Origin Fertility Care is a private fertility clinic regulated by the RQIA and HFEA.The Clinic treats day patients only and has no in-patient beds. The clinic holds a small stock of controlled drugs within one secure area. It has an agreement with a local pharmacist who supplies its controlled drugs.

Medicine Management is reviewed annually as part of its quality management system.

Policies and procedures are maintained and updated regularly to reflect any changes in legislation and best practice.

All appropriate staff complete annual medicines management training covering controlled drugs.

6. The Department of Health

a. Community Pharmacies

A declaration and self-assessment form is issued to all community pharmacies annually.  The self-assessment covers all aspects of the management of controlled drugs including specific written SOPs, staff training, prescribing patterns, diversion, complaints, transport, labelling, date checking and audit checks. The declaration confirms that the pharmacist, to the best of their knowledge and belief, is complying with the legal requirements in relation to controlled drugs. The declaration and self-assessment is reviewed by MRG Inspectors during pharmacy inspection visits. 

A Memorandum of Understanding in place between the Department and HSCB allows the formal transfer of information relating to controlled drugs between both organisations.  Inspection software has been modified to facilitate communication with the HSCB Business Services Organisation in respect of receipt by the Department of enhanced controlled drug data for use during community pharmacy inspections.  This process began with the signing of a data sharing access agreement between the Department and the HSCB Business Services Organisation. 

A risk-based inspection process was introduced in April 2011 for the inspection

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of community pharmacies. In relation to controlled drugs, the inspection process covers: maintenance of the controlled drugs register, safe custody of controlled drugs, diversion of controlled drugs, SOPs for the management of controlled drugs, disposal of out of date and returned controlled drugs, stock audits and a review of the annual declaration and self-assessment form.  Any action points are agreed and the completed inspection report is signed by the Inspector and the pharmacist and a copy forwarded to the pharmacist.

Inspections are planned to be conducted within a (maximum) forty two month cycle and are prioritised following the risk-based inspection. A quarterly report is forwarded to the HSCB Accountable Officer detailing the pharmacies inspected, any controlled drug issues which have arisen and the actions taken to resolve these issues.

b. NIAS HSC Trust

The routine inspection of NIAS stations was introduced in 2011 to review the management of morphine held by the stations. The inspections are carried out by MRG officers who examine both the station records and the personal records of paramedics. These records are used to provide an audit trail for morphine within the station.  Each pain pack containing morphine has a unique identification number which is reconciled with the packs received, the packs allocated to individual paramedics and which packs have been used for patient administration.  This is a detailed and robust audit which not only reconciles the number of pain packs received but also their distribution and utilisation to and by the paramedics.  The inspection report is signed by the Station Officer and the Inspector and a copy forwarded to the Station Officer and to the NIAS Accountable Officer. Any issues arising are resolved in conjunction with the Station Officer and the NIAS

Accountable Officer. Inspections are carried out within a twenty four month cycle and are prioritised following the risk-based inspection.

c. Trust Pharmacies

Medicines Regulatory Group (MRG) inspectors conduct a cycle of compliance visits to ensure that management of controlled drugs in the Trust pharmacies complies with legislation and good practice.

d. Hospices

Again, a cycle of compliance visits by MRG inspectors takes place on a thirty six month basis at these facilities.  Routine inspections are not due again until 2018.  Interim visits are made, when requested by staff, to witness the destruction of unwanted or date-expired Schedule 2 controlled drugs.

e. Contract Research Organisa-tions

Compliance visits by MRG inspectors, in relation to Misuse of Drugs legislation and associated good practice for the management of controlled drugs, are conducted at two facilities conducting Phase I-II clinical trials.   Routine inspections of the establishments were conducted in February and March 2015.

f. Authorised Witnesses

Misuse of Drugs legislation requires that date-expired or otherwise unwanted Schedule 2 controlled drugs stock be destroyed only under the supervision and direction of a witness authorised by the Department. A programme for the training and authorisation of witnesses in Trusts and the larger community pharmacy chains continues to be managed by MRG.

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7. The Regulation and Quality Improvement Authority

The Regulation and Quality Improvement Authority (RQIA) routinely monitors the management of controlled drugs in relevant registered facilities, through its regulatory activity.

The notifications to RQIA of incidents and near misses involving controlled drugs have highlighted anomalies in the administration of prescribed controlled drug patches. The most frequent reported occurrence continues to be the late administration of patches. Registered establishments are encouraged to analyse all incidents and implement any learning which could improve practice. The importance of ensuring controlled drug patches are administered in accordance with the prescriber’s directions is emphasised at all relevant inspections and RQIA inspectors continue to monitor this.

When concerns are identified in relation to the management of controlled drugs, these are discussed with registered providers and when appropriate are referred to the Accountable Officer in the relevant Trust.

If any notifiable event reported to RQIA identifies issues in relation to the prescribing or dispensing of controlled drugs these are referred to the Health and Social Care Board.

As part of the regulatory activity in 2015-16, medicine management inspections took place in the independent hospitals which are required to appoint an Accountable Officer. These evidenced that the hospitals had robust systems in place for the management of controlled drugs.

During 2015-16, RQIA engaged with the DoH to contact several independent hospitals in order that DoH could determine if the hospitals met the definition of ‘Relevant Independent Hospital’ and as such were required to appoint an Accountable Officer.

Guidance on medicine management is available to registered establishments and enforcement action on RQIA’s website (www.rqia.org.uk).

Appendix 1

Secure the Safe Management and Use of Controlled Drugs

The scope of Controlled Drugs use that falls under the remit of HSCB is significant as it covers the entirety of Primary Care. By way of example, table 1 below sets out the volume of prescriptions and dosages dispensed in Primary Care in Northern Ireland.

Controlled Drugs Dispensed in NI: 2011 - 2015

Items QtyControlled Drugs Schedule Controlled Drugs Schedule

Year 2 3 4 5 2 3 4 5

2011237,47

1 486,004 875,395 1,503,988 12,655,134 11,381,973 33,362,462 127,501,5602012 259,53 474,324 860,045 1,543,009 13,314,390 10,670,462 32,117,138 129,411,640

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1

2013278,92

2 460,205 853,924 1,551,271 14,225,093 9,918,735 31,789,474 128,002,210

2014302,28

1 674,332 1,022,798 1,565,545 17,944,991 23,526,620 36,441,509 127,906,641

2015329,58

7 876,185 1,191,980 1,579,489 21,904,140 35,587,171 40,435,480 128,957,157

Appendix 2 – Primary Care Prescribing Data

Chart 1 – This chart depicts the top 10 controlled drugs by prescription volume in Northern Ireland

Chart 2 – This chart depicts the top 10 Schedule 2 controlled drugs by prescription volume in Northern Ireland

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Chart 3 – This chart depicts the overall prescribing volume of Schedule 2 and Schedule 3 controlled drugs

The large increase in the prescribing Schedule 3 that can be seen between 2013 and 2014 is due to the change in legislation that occurred in June 2014, when tramadol became a schedule 3 CD. As illustrated in Chart 1 (above), tramadol is a widely used analgesic and is the third most commonly prescribed CD across all the schedules.

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Chart 4 – This chart depicts the overall prescribing volume of tramadol, a newly categorised Schedule 3 controlled drug

Chart 5 – This chart depicts the overall prescribing volume of benzodiazepines

Chart 6 – This chart depicts the overall prescribing volumes of zopiclone, zaleplon and zolpidem

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Chart 7 – This chart depicts the top 10 controlled drugs by volume that are ordered on Stock prescriptions

Chart 8 - This chart depicts the trends in stock ordering of controlled drugs

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Appendix 3Background to the Introduction of the Controlled Drugs

(Supervision of Management and Use) Regulations (Northern Ireland) 2009

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As a result of the actions of Harold Shipman, an Inquiry, chaired by Dame Janet Smith DBE, was established which published 6 reports between 2002 and 2005. In the Inquiry’s Reports, Dame Janet Smith considered the systems for the management and regulation of controlled drugs, together with the conduct of those who operated those systems.

The Inquiry identified some key strengths within the arrangements which already existed in Northern Ireland. These included an acknowledgement of the benefits of the centralised arrangements which were integrated within the Department of Health, Social Services and Public Safety (“the Department”) providing expertise of a multi-disciplinary nature and integration and collaboration with other professional bodies and investigation/enforcement authorities. The significant changes which have since been made in both governance and legislation surrounding the management and use of controlled drugs have sought to build on these existing governance arrangements.

Legislative changes made include:

Introduction of Health Act in 2006 Amendments to Misuse of Drugs

Regulations (Northern Ireland) 2002

Introduction of The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 (the Regulations)

The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 came into operation on 1 October 2009 and apply to all healthcare settings and individual practices where controlled drugs are used covering activities such as prescribing, administering, storage, transportation and disposal.

These arrangements were designed to:

Improve systems for managing and identifying concerns about controlled drugs

Provide comprehensive and co-ordinated arrangements for monitoring and inspecting

Establish a mechanism to support collaboration and information sharing

Underpinning these improvements was the determination that they would not compromise clinical care and patients’ access to this care.

The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 amend the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009, the ‘principal’ Regulations.

These amendments have been made to make provision for additional safeguards for the safe management and use of Controlled Drugs introduced in England and Scotland when the Controlled Drugs (Supervision of Management and Use) Regulations 2013 which came into force on 1 April 2013.The opportunity has also been taken to align certain arrangements with those in England, Scotland and Wales.A summary of the key amendments is outlined below:

The definition of relevant independent hospitals has been inserted to take account of those independent hospitals which are not providing healthcare, have no controlled drug activity, and where

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a determination would create disproportionate difficulties for the independent hospital in question. These independent hospitals will not be caught by the Regulations

The armed forces are given the status of a designated body and discrete provision for Northern Ireland Ambulance Services ‘NIAS’ has been omitted.

The conditions for appointing an Accountable Officer have been amended to provide more flexibility for smaller organisations while ensuring that the Accountable Officer has sufficient seniority to have credibility within their organisation

The list of Standard Operating Procedures ‘SOPs’ which designated bodies shall have has been extended to include a requirement for SOPs covering the prescribing, supply and administration of controlled drugs and the clinical monitoring of patients prescribed controlled drugs

The definition of a relevant person has been extended and now includes all health care professionals and is not limited to health care professionals providing medical, dental, pharmaceutical and nursing or midwifery services to private patients

A provision has been made for occurrence reports to be submitted more frequently than quarterly where there are concerns that warrant it and a request has been made by the accountable officer of the Regional Board

Protection from civil proceedings has been extended to include all Regulations.

Accountable Officers

The Regulations identified the organisations (Designated Bodies) which were required to nominate individuals, known as Accountable Officers, who would be responsible for the management and use of controlled drugs in their organisation. The Designated Bodies (DBs) prescribed by the legislation are as follows:

the regional HSC Board (HSCB)

all HSC Trusts

a Relevant Independent Hospital.

the headquarters in NI of regular or reserve forces

Accountable Officer Website

A section of the Pharmaceutical Advice and Services Departmental website has been dedicated to support the work of the AOs. Responsibility for some of this content transferred to the HSCB during 2015. The Department will continue to maintain the list of Accountable Officers which provides the name, address, telephone number and e-mail address for each Accountable Officer and can be found at: https://www.health-ni.gov.uk/sites/default/files/publications/dhssps/accountable-officer-contact-list.pdf

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Where can I find information about Accountable Officers and the legislation?

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The Local Intelligence Network

The concept of a Local Intelligence Network (LIN) was introduced 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.

The Northern Ireland Local Intelligence Network

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

The LIN is attended by Accountable Officers, representatives of the regulators, the Police, the Department of Health and the Counter Fraud Unit of the Business Services Organisation (BSO), collectively known as Responsible Bodies.

Accountable Officers submit their quarterly Occurrence Report to the Chair of the LIN and concerns arising from these reports are shared within the confines of the confidential LIN meeting. Organisations can share well-founded concerns and, wherever possible, learn from these concerns.

Designated Bodies are also encouraged to share good practice within this arena.

GuidanceThe Department developed a range of guidance documents to promote the safe and effective use of controlled drugs in healthcare organisations. These include guides to good practice which were developed for the secondary care sector in 2009 (updated in August 2012) and the primary care sector in 2010 (updated in May 2013). These provide background to the Regulations and take account of legislative changes and developments in professional practice and accountability which have arisen as a result of the Shipman Inquiry’s Reports.

Guidance on ‘Managing and Sharing Concerns’ and ‘Safer Management of Controlled Drugs - A Guide to Strengthened Governance Arrangements in Northern Ireland were revised in September 2013. https://www.health-ni.gov.uk/publications/guidance-safe-management-and-use-controlled-drugs

All guidance documents can be found on the Department’s Accountable Officer website.

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Appendix 4 - Number of Meetings Attended by Individual Bodies in 2015-16 (out of possible 4)

Designated Bodies

NameNumber of Meetings

Attended

Belfast HSC Trust 2Northern HSC Trust 4Southern HSC Trust 4South Eastern HSC Trust 4Western HSC Trust 3Northern Ireland Ambulance Service 4Regional HSC Board 4Fitzwilliam Clinic 2Foyle Hospice 4GCRM Ltd, Belfast 2Hillsborough Private Clinic 2Kingsbridge Private Hospital 3Marie Curie Hospice 2Ministry of Defence 2North West Independent Hospital 2Northern Ireland Children’s Hospice 2Northern Ireland Hospice 3Origin Fertility Care 1St John’s Hospice Newry (Southern Area) 3Ulster Independent Clinic 3

Counter Fraud Unit of BSO 2Department of Health 4General Dental Council 0General Medical Council 3Health and Care Professions Council 1Northern Ireland Social Care Council 2Nursing & Midwifery Council 3Pharmaceutical Society of Northern Ireland 0Police Service of Northern Ireland 2Regulation & Quality Improvement Authority 2