Amendments to the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) Consultation Response Report

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1 Amendments to the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 Consultation Response Report June 2015

2 INDEX 1. Summary 2. Background 3. Consultation feedback 2

3 1. Summary The Department of Health, Social Services and Public Safety (the Department) launched a 14 week consultation on amendments to the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009 ( the Regulations ). The consultation ran from 26 January 2015 until 1 May The consultation document was available on the Department s website and was circulated widely to various stakeholders and representative bodies. In total, 14 responses were received, 13 in questionnaire format and 1 free format response. This was made up of 12 responses on behalf of organisations and 2 which were made on behalf of individuals. The full list of respondents is provided at Annex A. Respondents are categorised as follows: - Health and Social Care providers Professional/Educational organisations Individuals Regulators Others 5 responses 4 responses 2 responses 2 responses 1 response Outside the formal responses the Department received correspondence from the Office of the Attorney General for Northern Ireland. Section 3 of this report provides a summary of the responses received for each of the questions that were asked as part of the consultation and sets out the Department s position in relation to any points raised Background The Regulations were designed to improve controlled drug governance without hindering patients from accessing the treatment they needed. The Regulations, as far as possible, replicated measures for the supervision of management and use of controlled drugs which came into force in England, Scotland and Wales and have not been subject to amendment until now. England and Scotland reviewed their equivalent Regulations in 2013 and a range of additional governance arrangements were introduced. These additional governance arrangements were considered in the context of Northern Ireland healthcare services and amendments were proposed and

4 consulted upon. The Department also used the amendment Regulations to update legislative references and to make other minor technical corrections. These regulations are subject to negative resolution. The Department would like to thank all of the participants in this process for their responses which have been largely supportive of the proposals. Having carefully considered and taken account of the consultation responses the Department will continue the legislative process to bring the Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 into operation by July Consultation feedback The report follows the questionnaire structure. A short piece of explanatory text sets out the context for the questions. Only comments which suggest changes to the legislation or highlight issues to be addressed have been included in this report. Question 1: Do you agree to the interpretation of a regulatory body being amended to include the Northern Ireland Social Care Council? The range of health care workers whose employment does or could require them to have some involvement in the management and use of controlled drugs extends beyond the regulatory bodies captured under the current regulations. Social care workers are employed in settings where medication is administered and are regulated by Northern Ireland Social Care Council (NISCC). Yes % No 0 0% No view 0 0% Comment received: ---If the Northern Ireland Social Care Council is to be included within the definition of a regulatory body for these purposes, this clause must be redrafted. Professional body All those who responded to the consultation agreed with the proposal to amend the interpretation of a regulatory body to include the Northern Ireland 4

5 Social Care Council. Having considered the comment above the clause has been re-drafted. The re-drafted amendment will be progressed.. Question 2: Do you agree that only independent hospitals which provide health care and which manage and use CDs should be required to appoint an Accountable Officer (AO)? As a result of the re-registration of independent clinics by the Regulation and Quality Improvement Authority (RQIA) as independent hospitals in 2014 these organisations are now prescribed as designated bodies under the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) Many of these newly registered independent hospitals would be required to nominate an AO with legislative responsibilities for the management and use of CDs while having little or no CD usage. Yes 13 93% No 0 0% No view 1 7% All respondents, with the exception of one expressing no view, supported this proposal. The amendment will be progressed as proposed. Question 3: Do you agree that the Department should be able to determine, but only where it is desirable to do so, that an independent hospital should not be required to appoint an Accountable Officer (AO) and the proposed criteria that the Department would adopt? Some of the newly registered independent hospitals have only limited controlled drug (CD) activity. For these smaller independent hospitals 5

6 inclusion within the Regulations is likely to impose a disproportionate burden on their organisation. Yes 13 93% No 0 0% No view 1 7% Comments received: ---the DHSSPS has not specified what arrangements would be put in place to ensure public protection, safety and compliance with legislation in circumstances where it determines that the appointment of an Accountable Officer is not required. --- accepts that the appointment of Accountable Officers must be sensible and proportionate, public protection considerations must supersede any concerns about the financial implications of appointing Accountable Officers.- Professional body All respondents, with the exception of one expressing no view, supported this proposal. A concern was expressed on the absence of detail on the specific arrangements and finance considerations superseding those of public protection. The Department, supported by RQIA, will develop robust arrangements to determine which independent hospitals are to be required to appoint an AO. Patient and public safety will be prioritised in making each determination, all of which will be reviewed annually. Those that are not required to appoint an AO will continue to be inspected by RQIA. The amendment will be progressed as proposed. Question 4: Do you agree the list of designated bodies required to appoint AOs including the armed forces? To align with the arrangements in England and Scotland it was proposed that the armed forces would be included in the list of designated bodies. The list of designated bodies in Northern Ireland is now proposed to be as follows: a) the Regional Board b) an HSC Trust c) a relevant independent hospital d) the headquarters in Northern Ireland of regular or reserve forces. 6

7 Yes 12 86% No 0 0% No view 2 14% All respondents, with the exception of two expressing no view, supported this proposal. The amendment will be progressed as proposed. Question 5: Do you agree the conditions for the appointment of an Accountable Officer? The 2009 Regulations stipulate that the AO appointed by an independent hospital must be the registered manager or answerable to the registered manager. This has presented difficulties for some smaller independent hospitals particularly where separating the duties of the registered manager from routine involvement with CDs has been challenging. Yes 12 86% No 0 0% No view 2 14% Comments received: -- agrees that there should be conditions relating to the appointment of AOs, further clarity is required regarding the term significant role Regulator All respondents, with the exception of two expressing no view, supported this proposal. One respondent requested clarity regarding the term significant role. Guidance will be developed which will indicate the level of seniority the AO would be expected to assume within their organisation. The amendment will be progressed as proposed. 7

8 Question 6: Do you agree that Standard Operating Procedures (SOPs) on prescribing, supply and administration of CDs and the clinical monitoring of patients using CDs should be added to the current list of SOPs? The list of SOPs in England and Scotland is now less prescriptive. They no longer require a mandatory list of SOPs but specify that SOPs are to be maintained on the prescribing, supply and administration of CDs and the clinical monitoring of patients using CDs. In Northern Ireland it was proposed that the current mandatory list of SOPs is maintained and to that would be added SOPs on prescribing, supply and administration of CDs and the clinical monitoring of patients using CDs. Yes 12 86% No 1 7% No view 1 7% Comments received: amendments in England and Scotland have led to the removal of a mandatory list of SOPs on access, storage and disposal albeit up to date SOPs relating to prescribing, supply and administration of CDs and clinical monitoring of patients on CDs is included. In my view it would be important to maintain parity with England and Scotland for SOP obligations--- Professional body There is significant agreement for this proposal. The Department liaised with AOs prior to the consultation process to establish their views and they were in favour of maintaining the mandatory list. Other respondents sought clarity on the arrangements for clinical monitoring. Guidance will be developed to support AOs in relation to SOPs. Recognising that specific SOPs may not be relevant in all settings the Department has revised the proposal to. require organisations to have SOPs in place only where these are applicable to the designated body. The amendment will be progressed with this revision. 8

9 Question 7: Do you agree that the HSC Board AO should have legislative responsibility for the operation of the Local Intelligence Network (LIN) and the arrangements for occurrence reports? The 2009 Regulations came into operation at a time of major reorganisation for HSC organisations. As a consequence, the responsibility for establishing the LIN was not assigned to the AO of the HSC Board. This responsibility has now been transferred from the Department to the AO of the HSC Board and it was proposed that this would be enshrined in legislation. Furthermore provision was proposed for AOs to submit occurrence reports more frequently than quarterly should there be concerns that warrant it. Yes 13 93% No 0 0% No view 1 7% All respondents, with the exception of one expressing no view, supported this proposal. The amendment will be progressed as proposed. Question 8: Do you agree that the definition of a relevant person should be extended to include all health care professionals? The Regulations place a duty of co-operation on organisations (responsible bodies) permitting them to share information giving rise to concerns about the management or use of controlled drugs by any relevant person. It was proposed that the definition of relevant person would be simplified and widened to capture all healthcare professionals engaged in controlled drug activities similarly to England and Scotland. Yes % No 0 0% No view 0 0% Comments received: The inclusion of the NISCC as a regulatory body means the inclusion of the social care workforce - both social workers and social care workers. 9

10 Consideration should be given as to whether social care should be captured in the definition of relevant person. - Regulator All respondents supported this proposal. In consultation with colleagues in the Office of Social Services (DHSSPS), the HSC Board AO and NISCC consideration has been given to the comment on inclusion of social care in the definition of relevant person. It has been concluded that this amendment should not be made without considering the full implications of such a change. This matter will therefore be further explored with key stakeholders and any proposals for change progressed at a later stage. Regulation 15 of the proposed amendments has been further amended to include a domiciliary care agency under the purview of this regulation. This amendment ensures that the patient and public protection afforded by these Regulations in respect of nursing and residential care homes is now extended to domiciliary care agencies. This amendment ensures that a social care worker, engaged in the supply or administration of controlled drugs in a domiciliary care agency setting, would be caught by the Regulations, insofar as they would be regarded as a relevant person. The amendment will be progressed as proposed. Question 9: Do you agree the information sharing provisions of regulation 19? To extend the provisions for information sharing to enable a well founded concern to be shared about the inappropriate or unsafe management or use of controlled drugs by a person, who may or may not currently be a relevant person, with a designated body where it is considered that the person could become a relevant individual for the designated body. Furthermore clarification has been provided that one of the actions available to the HSC Board AO, in certain circumstances, is to share information with any person, whether they are a member of the LIN or not, who employs or may employ an individual if there are well-founded concerns about that individual s activities which might jeopardise patient or public safety. 10

11 Yes 13 93% No 1 7% No view 0 0% Comments received: --- We endorse the right of the Health and Social Care Board Accountable Officer to take appropriate action to ensure that concerns over the inappropriate or unsafe management or use of controlled drugs by a particular individual are addressed in the interests of public protection. In some exceptional cases, this may necessitate sharing information with potential employers. However, the process for addressing concerns about the fitness to practise (whether related to professional misconduct or ill health, or a combination thereof) of any health care professional focuses upon reporting the circumstances to the appropriate professional regulatory body. A range of statutory measures, including interim suspension of registration, can then be deployed to ensure public protection. --- believes that public protection must be secured in this respect through the statutory procedures of the relevant regulatory body and we believe that the DHSSPS should ensure that this point is reiterated in the revised legislation. All but one respondent supported this proposal. Currently regulation 17(2)(c) of the 2009 Regulations makes provision for well-founded concerns to be referred to a regulatory body. This is reinforced within guidance developed for the Local Intelligence Network on Managing and Sharing Concerns. Furthermore this will be highlighted in guidance developed when the amendment Regulations come into operation. The Department has taken legal advice on the proposed amendment and, as a result, this been revised to restrict regulation 30(1) to information shared under regulation 25 or 26. This enables the LIN to share information only where it relates to a relevant person. The proposed amendment will be revised and progressed. 11

12 Question 13: Human Rights and Equality Implications Are there any aspects of this where potential human rights violations may occur? Two respondents replied yes to this question and commented: ---the potential human rights implications of denying an individual s right to practise their profession without firm evidence that to do so would be in the interests of public protection and without following established statutory procedures. - Professional body Follow up and retraction of names shared if circumstances change difficult to know when the relevant person has left the organisation. - Health and Social Care provider Department Response The draft Regulations do not allow the denial of an individual s right to practise. They provide a lawful basis for the exchange of information and a lawful basis for a recommendation. The human rights implications have been and continue to be carefully considered. The LIN has developed guidance ( Managing and Sharing Concerns ) to support AOs in the discharge of their responsibilities under the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) The issue of AOs reviewing and updating information shared with the LIN is included in this guidance which is subject to regular review. It is however the responsibility of the Accountable Officer to establish and operate appropriate arrangements for their organisation. Having taken legal advice the Department is of the view that this is not a legislative matter. 12

13 Annex A Consultation respondents North West Independent Hospital Hillsborough Clinic Dr Jane Wright South Eastern Trust R & D Nurse (individual) Maggie Ross / Donna Dillon SET Community Palliative Care Ed. Facilitators (individual) Royal College of Physicians of Edinburgh Regulation and Quality Improvement Authority Community Pharmacy Northern Ireland Police Service of Northern Ireland Health and Social Care Board Northern Ireland Ambulance Service Trust South Eastern Health and Social Care Trust Royal College of Nursing Northern Ireland Social Care Council The Northern Ireland Practice and Education Council for Nursing and Midwifery 13

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