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) 2009 (“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). 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 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 year with respect to the safe management of controlled drugs and investigations of concerns. South Eastern HSC Trust In 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. 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 The 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 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
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. Hospices 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. Contract Research Organisations 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. 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. 7. The Regulation and Quality Improvement Authority The Regulation and Quality Improvement Authority (RQIA) routinely monitors the management of controlled 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 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
Provide comprehensive and 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 (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. 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 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 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 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