1. The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009

2. Aims for to-day To explain The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 To explain The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 To respond to queries raised about the implications for staff within this organisation To respond to queries raised about the implications for staff within this organisation

3. Background On 31 January 2000, Harold Shipman was convicted of murder of 15 patients. However actual death toll around 200. On 31 January 2000, Harold Shipman was convicted of murder of 15 patients. However actual death toll around 200. Inquiry chaired by Dame Janet Smith Inquiry chaired by Dame Janet Smith 6 reports including recommendations 6 reports including recommendations

4. Shipman Inquiry Fourth Report – Regulation of Controlled Drugs in the Community Fourth Report – Regulation of Controlled Drugs in the Community Fifth Report – Safeguarding patients: Lessons from the Past – Proposals for the Future Fifth Report – Safeguarding patients: Lessons from the Past – Proposals for the Future Dame Janet Smith praised the centralised nature of the inspection arrangements for controlled drugs in NI Dame Janet Smith praised the centralised nature of the inspection arrangements for controlled drugs in NI Recommendations from 4 th and 5 th reports can be seen in Health Act 2006 and The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 Recommendations from 4 th and 5 th reports can be seen in Health Act 2006 and The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009

5. The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 Made 5 June 2009 under Health Act 2006 Made 5 June 2009 under Health Act 2006 Similar to England/Scotland/Wales Regulations Similar to England/Scotland/Wales Regulations Into operation 1 October 2009 Into operation 1 October 2009 Maximise structures and processes already in place and use these to develop systems that will ensure the safe management and use of controlled drugs Maximise structures and processes already in place and use these to develop systems that will ensure the safe management and use of controlled drugs Formalises existing arrangements Formalises existing arrangements Legislation relates to all CDs (Sch 1 to Sch 5) Legislation relates to all CDs (Sch 1 to Sch 5)

6. Main areas that legislation covers Identifies Designated Bodies Identifies Designated Bodies Appointment of an Accountable Officer Appointment of an Accountable Officer Routine Monitoring Routine Monitoring Investigating concerns Investigating concerns Duty of collaboration Duty of collaboration

7. Designated Bodies Each Designated Body is required to appoint an Accountable Officer Each Designated Body is required to appoint an Accountable Officer 17 in total 17 in total –Board –5 Trusts –Northern Ireland Ambulance Service –Independent Hospitals (includes Hospices)

8. Accountable Officers (AOs) 16 in total (two hospices share an AO) 16 in total (two hospices share an AO) fit, proper and suitably experienced person fit, proper and suitably experienced person the person does not routinely supply, administer or dispose of controlled drugs as part of his duties the person does not routinely supply, administer or dispose of controlled drugs as part of his duties In specified circumstances may be shared by two or more Designated Bodies In specified circumstances may be shared by two or more Designated Bodies Register of AOs held by DHSSPSNI Register of AOs held by DHSSPSNI

9. Accountable Officers and Designated Officers Duties of AOs include, but are not limited to: Duties of AOs include, but are not limited to: –Ensuring safe management of CDs –Ensure SOPs in place –Ensure safe destruction/disposal arrangements May appoint a Designated Officer to assist with any of their responsibilities May appoint a Designated Officer to assist with any of their responsibilities

10. Routine Monitoring AO has responsibility for routine monitoring of controlled drugs within their Designated Body and shall ensure that any person acting on behalf of or providing services under arrangements made with his Designated Body also has systems in place AO has responsibility for routine monitoring of controlled drugs within their Designated Body and shall ensure that any person acting on behalf of or providing services under arrangements made with his Designated Body also has systems in place Can include: Can include: –Analysing prescribing data –Self-assessments/declarations/inspections –Incident reporting/complaint handling

11. Self-assessment and Declaration Regulation 12 Regulation 12 Board Board RQIA RQIA Department Department –Registered pharmacies –Annually –Retain in CD register

12. Investigating concerns AO has responsibility to: AO has responsibility to: –Assess concerns –Investigate where appropriate –Can request assistance from other Designated Bodies –Take action where appropriate –Report to Local Intelligence Network (LIN)

13. Responsible Bodies Includes all Designated Bodies and also the Department, RQIA, CFU, Regulatory Bodies and Police Includes all Designated Bodies and also the Department, RQIA, CFU, Regulatory Bodies and Police Ensures effective inspection, investigation and collaboration of controlled drug matters Ensures effective inspection, investigation and collaboration of controlled drug matters

14. Duty of Collaboration Local Intelligence Network Local Intelligence Network Develop communication between Responsible Bodies Develop communication between Responsible Bodies Held quarterly Held quarterly Share concerns within set guidelines (Occurrence Reports) Share concerns within set guidelines (Occurrence Reports) Collate and disseminate learning points from concerns/incidents Collate and disseminate learning points from concerns/incidents

15. What is happening? Legislation comes into operation Legislation comes into operation –1 October 2009 Date of first LIN Date of first LIN –1 December 2009 Other forums for sharing information Other forums for sharing information –Cross Border Intelligence Group –National Controlled Drugs Group Self-assessments/declarations Self-assessments/declarations Periodic and routine inspections Periodic and routine inspections

16. Sources of Information DHSSPS web-site www.dhsspsni.gov.uk/index/pas DHSSPS web-site www.dhsspsni.gov.uk/index/pas www.dhsspsni.gov.uk/index/pas –Contact details of Accountable Officers –Contact details of Responsible Bodies –Occurrence Report template –FAQs on web –Guidance documents –Legislation

17. In summary Identifies Designated Bodies Identifies Designated Bodies Appointment of an Accountable Officer Appointment of an Accountable Officer Routine Monitoring Routine Monitoring Investigating concerns Investigating concerns Duty of collaboration Duty of collaboration