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Controlled Drugs Policy For NHS Kirklees Responsible Directorate: Responsible Director:

Patient Care and Professions (Medicines Management) Sheila Dilks

Date Approved: 25/3/2009 Committee: Governance Committee NICE GUIDANCE Once NICE guidance is published, health professionals are expected to take it fully into account when exercising their clinical judgment. However, NICE guidance does not override the individual responsibility of health professionals to make appropriate decisions according to the circumstances of the individual patient in consultation with the patient and/or their guardian or carer.

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Version Control Document Title: Document number: Author: Contributors: Version: Date of Production: Review date: Postholder responsible for revision: Primary Circulation List: Web address: Restrictions:

Controlled Drugs Policy for NHS Kirklees 1 Neill McDonald Terry Service 1 February 2009 March 2011 (or sooner if required) Assistant Director of Medicines Management & Prescribing NHS Kirklees Staff (inc KCHS staff)

Standard for Better Health Map Domain: 1st Domain - Safety Core Standard Reference: C4d Performance Indicators: 1.Up to date guidance and SOPs available and disseminated to contractors and staff for CD management 2.Statutory returns are obtained from all appropriate providers of services within the specified timescales 3.A Local Intelligence Network has been developed and meets on a quarterly basis 4.Occurence reports are provided from all organisations required to appoint an accountable officer every quarter (within NHS Kirklees). 5. The number of providers / contractors who have had a Controlled Drugs inspection (minimum 15% each year) and have inspection reports available

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Contents

Section 1. 2. 3. 4. 5. 6. 6.1 6.2 6.3 6.3.1 6.3.2 6.3.2.1 6.3.2.2 6.3.2.3 6.3.2.4 6.3.3 6.3.4 6.3.5

Introduction Associated policies and procedures Aims and Objectives Scope of the policy Accountabilities Policy Compliance with legislation Corporate accountability Governance arrangements The Accountable Officer Monitoring Monitoring of prescribing Annual CD self declarations Routine inspection of premises Collation and review of information Managing concerns, complaints and poor performance Managing patient safety incidents Calderdale, Kirklees and Wakefield Local Intelligence Network 6.3.6 Occurrence reports 6.4 Confidentiality and information governance 6.5 Controlled drugs registers and records 6.6 Destruction of controlled drugs 6.7 Developing services that utilise controlled drugs 6.8 Provision of advice, guidance and training 7 Equality impact assessment 8 Training needs analysis 9 Monitoring compliance with this policy 10 References and further reading Appendices A B C D E F G H I

J K

Definitions Key Stakeholders consulted/involved in the development of the policy/procedure Equality Impact Assessment Tool Monitoring of Controlled Drug Prescribing Statutory declaration forms (parts 1 and 2) Principles of inspection of public services Controlled drug inspection proformas Summary cause for concern process flowchart Calderdale, Kirklees and Wakefield Local Intelligence Network Operating Framework / Information sharing agreement Controlled Drugs Occurrence report proforma Controlled Drugs Legal & Best Practice Guide

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Page 4 4 4 5 5 6 6 6 7 7 7 7 8 10 11 11 12 12 13 14 14 14 15 15 15 15 16

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Policy Statement NHS Kirklees will ensure that systems and governance processes are in place to assure the safe and effective use of Controlled Drugs across NHS Kirklees in accordance with the Health Act 2006, and the Misuse of Drugs Act and supporting regulations.. All staff employed by NHS Kirklees, including Kirklees Community Health Services, are required to follow this policy, and associated legal and best practice guidance. Primary care contractors are required to follow legal requirements in respect to Controlled Drugs, and are encouraged to follow best practice guidance provided by NHS Kirklees.

1. Introduction The purpose of this document is to set out the PCT’s policy on the management and governance of controlled drugs (CDs). The arrangements set out here provide the basis upon which the PCT will endeavour to comply with the requirements of the Misuse of Drugs Act 1971 and its related regulations and the Health Act 2006 (Part 3). The use of CDs are an essential part or providing high quality healthcare to patients. It must be clear that whenever there is a clinical need for a controlled drug to be used, patients should have access to that treatment in the most appropriate place and at the most appropriate time for them. That being said the law relating to CDs must be upheld at all times and without exception by all providers of health or social care. Contained within this policy are the arrangements the PCT has in place to supervise the management and use of CDs. Such arrangements are intended to act as a deterrent to the misuse of CDs whilst providing robust measures to identify the misuse of CDs that are proportional to the risk of harm to patients, the public and staff. Separate legal and best practice guidance, including example Standard Operating Procedures have also been developed to support this policy. Additional supporting documents are available which provide guidance and information on the monitoring and implementation of this policy.

2.

Associated policies & procedures

This policy should be read in accordance with the following Trust policies, procedures and guidance: • • • • 3. • • • • •

Medicines Management Policy Information Sharing Agreement in respect of the operation of the Calderdale, Kirklees and Wakefield Local Intelligence Network for Controlled Drugs. PCT Serious Untoward Incident Policy Controlled Drugs Legal & Best Practice Guidance Aims and objectives To ensure that the law in relation to controlled drugs management is upheld To ensure the safe and effective handling and use of Controlled Drugs To ensure systems and processes are in place to assure compliance with the requirements identified with the Health Act 2006 in relation to the management of controlled drugs, and Healthcare Commission Core standards in relation to Controlled Drugs management To develop good practice for the management of Controlled Drugs in Primary Care Enhancing patient and public safety

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• 4.

To ensure Standard Operating Procedures are developed and in operation in all areas where Controlled Drugs are prescribed / handled. Scope of the policy

This policy, including associated appendices, and “Legal and Best practice Guidance� must be followed by all NHS Kirklees employees who are involved in the management and / or use of controlled drugs. It must be followed by all staff who work for NHS Kirklees, including those on temporary or honorary contracts, bank staff and students. Breaches of this policy may lead to disciplinary and / or legal action being taken against the individual. Independent Contractors are responsible for the development and management of their own procedural documents and for ensuring compliance with relevant legislation and best practice guidelines. Independent Contractors are encouraged to seek advice and support as required. 5.

Accountabilities and Responsibilities

The Controlled Drugs Accountable Officer has overall accountability for the management of controlled drugs across NHS Kirklees.

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6.

Controlled Drugs Policy

6.1

Compliance with legislation

The PCT will take every reasonable endeavour to ensure that the Misuse of Drugs Act 1971 and related legislation pertaining to the management of controlled drugs is complied with by its staff and providers of NHS services within primary care. Similarly the PCT expects all its staff and providers of primary healthcare services, including primary care contractors, to comply with CD legislation without exception. The PCT will designate a controlled drugs “accountable officer� (AO) who is an executive director or a person who reports to an executive director, who is responsible for the ensuring the PCT operates appropriate arrangements for securing the safe management of controlled drugs. 6.2

Corporate accountability

The diagram below describes the lines of corporate accountability for the management of controlled drugs within NHS Kirklees.

Healthcare Commission

PCT Board

PCT Accountable Officer

Integrated Governance

The Healthcare Commission requires the PCT to provide evidence of its compliance with CD legislation as part of the annual health check against standard C4d (medicines are safely and securely handled) within Standards for Better Health. There is a specific section within standard C4d relating to Controlled drugs management.

6.3 Governance arrangements The supervision of controlled drugs management by the PCT, wherever possible, is to be part of the PCT integrated governance arrangements. However within these arrangements matters affecting the management of controlled drugs require special attention. On a general day to day management and monitoring basis, this will be managed via the PCT Medicines Management Team.

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6.3.1 The Accountable Officer The PCT will designate an “accountable officer” (AO) who is an executive director or a person who reports to an executive director, who is responsible for the ensuring the PCT operates appropriate arrangements for securing the safe management of controlled drugs. The PCT will make available those resources deemed necessary to allow the AO to execute their duties and responsibilities. 6.3.2 Monitoring A key aspect to the safe and secure management of CDs for PCTs is to ensure that robust CD monitoring arrangements are in place to act as a deterrent to the improper management or use of CDs. The PCT will conduct such monitoring as necessary to provide a reasonable level of assurance that CDs are not routinely being used improperly. It is recognised that, at present, no system of monitoring can be so robust as to identify every instance where a controlled drug is used inappropriately. The PCT will review the monitoring it performs as national databases that record CD transactions become available. 6.3.2.1

Monitoring of prescribing The PCT will monitor the prescribing of controlled drugs by all primary care providers of NHS care using data supplied through the e-PACT service. The prescribing of controlled drugs within private practice will similarly be monitored. The nature and extent of the monitoring is described in appendix D and is subject to amendment at the discretion of the AO in order to provide information of the necessary validity and reliability. Prescribing of CDs in Schedule 2 and 3 will receive higher levels of scrutiny than those in schedule 4. Drugs in Schedule 5 will not be routinely monitored. The data produced through analysis of e-PACT will be reviewed by the AO or a person designated by them to identify idiosyncratic prescribing. Any such prescribing will be managed as described in section 6.3.3

6.3.2.2

Annual CD self-declarations The AO or a person designated by them will request that an annual declaration (may be up to 24 months between declarations) (of the use of controlled drugs in schedule 2 and 3) is made by the following: •

All general medical practitioners on the PCT performers list (which will include locums).

All prescribers within PCT managed provider services (including non-medical prescribers) that maintain a stock of CDs in schedule 2 or 3.

All providers of NHS primary care services commissioned by or under agreement with the PCT (including contractor services) with the exception of those who are accountable to the Healthcare Commission, the Royal Pharmaceutical Society of Great Britain or the Commission for Social Care Inspection

The declaration to be made by Contractors will be requested in two parts:

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Part 1 will be requested at least every 2 years, and ideally annually. This is a brief form indicating the extent to which the contractor / health professional concerned is involved in CD prescribing, handling / management. For GPs, this will ideally be issued issued simultaneously with the GP annual appraisal documentation, however if this is not possible, it will be sent to individual GPs in the last quarter of the financial year. This will be a brief form indicating the extent of the GP’s involvement in CD prescribing or handling. For other contractor groups, this will be posted to the contractor In the last quarter of the financial year.

Part 2 is a detailed pro-forma, designed to capture information on the aspects of CD use that the prescriber / contractor has indicated he / she is involved with in Part 1 declarations These detailed declarations will be completed at a practice rather than individual practitioner level, unless there is good reason to request an individual part 2 declaration from a GP etc. only sections relevant to the management of CDs in the practice / service need to be completed. Exceptions might be where GPs manage or use CDs whilst providing medical services outside of the services provided by the practice or where GPs work in more than one practice. The information in part 2 declarations will enable the AO or a person acting on behalf of the AO to better interpret other information gathered in the course of CD monitoring.

The PCT will provide the opportunity for a CD declaration to be made, on a voluntary basis, by general dental practitioners on the PCT list of dental contractors, community pharmacy contractors and by private providers of healthcare that are known to the PCT and who are not registered with the Healthcare Commission,. Where this opportunity is not taken, at the discretion of the AO, routine inspection may be arranged on a more frequent or more extensive basis. See section 6.3.2.3. Declaration pro-forms can be found in appendix E and are subject to alteration at the discretion of the Accountable officer at any time. 6.3.2.3

Routine inspection of premises The routine inspection of premises will be co-ordinated by the office of the PCT Assistant Director of Medicines & Prescribing. Routine inspection of premises will be carried out in accordance with the ten principles of inspection set out in The Governments Policy on Inspection of Public Services. These principles can be found in appendix F. The PCT AO will maintain a list of persons designated by the PCT who can perform routine inspections of premises. The list of designated persons will include: •

The PCT AO

The PCT Director of Patient Care and Professions

The PCT Associate Medical Director/s

The PCT Assistant Director of Quality and Clinical Governance and members of his/her team.

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The PCT Assistant Director of Corporate Governance & Risk and members of his/her team

The PCT Assistant Director of Medicines Management and prescribing, and the members of his/her team

The list may be amended as necessary by the AO. Routine inspections will be carried out in the following premises: •

GP practices in the PCT that are providing NHS care (and their branch surgeries).

Dental Practices in the PCT that are providing NHS care.

Premises in the PCT where NHS primary care services are being delivered that have informed the PCT in the annual self declaration that controlled drugs are stored or handled on the premises.

Other premises where controlled drugs are stored or used for example providers of private health services where such services are known to the PCT (see also section 6.3.2.2).

Premises will not be routinely inspected by the PCT if: •

They are a patient’s home.

They are concerned only with the handling and use of patient’s own controlled drugs such as by palliative care & district nursing teams.

They are inspected by the Healthcare Commission, the Royal Pharmaceutical Society of Great Britain or the Commission for Social Care Inspection.

Where buildings are used for more than one purpose, inspections will be limited to those areas of a building that are used for the delivery of NHS services. During the course of an inspection consideration may be given to any or all aspects of the management of controlled drugs. An inspection pro forma can be found in appendix G and is subject to alteration at the discretion of the AO to meet the necessary level of assurance. The frequency and extent of the inspections of any premises will be proportional to the level of support that is needed to ensure the CD regulations are complied with. A random sample of premises will be identified for inspection each year (this will be at least 15% of practices). The aim is to ensure all premises where CDs are handled / stored will receive an inspection at least every 3 years. Where concerns j=have been identified, follow up inspections will bee carried out at a time interval defined by the inspection team and the CD AO. The extent of the inspection, which is the range of records, procedures or facilities that are examined, will also vary. The majority of routine inspections will examine a narrow range of aspects of CD management. Wherever possible these inspections will be carried out in the course of a medicines management advisory/QOF visit or other similar clinical governance visit. A random sample of at least 10% of premises (approximately 15 premises) each year will receive an inspection of a full range of aspects of CD management. Notification of the intention to carry out a routine inspection will ideally be provided at least 3 months prior to the date of inspection. Follow-up inspections will normally be arranged giving as much notice as possible but on occasion, at the discretion of the AO, may be conducted with no prior warning. It is intended to undertake inspection of all GP practices as soon as practicable to provide a baseline for measuring future improvements in CD management. Controlled Drugs Policy for NHS Kirklees

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See also targeted inspection in section 6.3.3 and Appendix H 6.3.2.4

Collation and review of information For each premises where CDs are used and or stored there must be a confidential file maintained that contains: •

The original copy of their annual CD declaration

A practice profile detailing any special interests that may result in unusual patterns of CD use

A record of CD related incidents, complaints and concerns with their corresponding outcomes and learning points. This record will incorporate: o

The Date the concern / incident was made known to the AO.

o

The date(s) on which the matter(s) causing concern arose

o

Details of the nature of the concern / incident

o

Details of the relevant individual(s) about whom the concern was expressed

o

Details of the person(s) reporting the concern / incident

o

A clear record of whether or not the concern was validated or proven

o

Details of the action taken or leaning outcomes that arose from investigation of the concern / incident.

o

An assessment of whether the information relating to the concern / incident should be released to another organisation or the LIN

Copies of any CD audits conducted in or by the practice / service.

Records of the dates of visits that were performed for the purposes of destruction of Stock CDs (see section 6.6) or patient returned CDs (for community phamacies)

Transcriptions from meetings where CD management concerns were discussed.

Reports of CD inspections

Information gained through the LIN or a LIN incident panel

Records of any information provided to persons outside the PCT including: o A description of the information passed on o The provenance of the information o An indication of whether the information passed on was anonymous o the date the information was passed on o The person to whom the information was passed on. o The reason provided by the person receiving the information for requesting it. o An indication of whether the person the information relates to has been informed about the provision of information.

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For individual practitioners: o A practitioner profile detailing any special interests that may result in unusual patterns of CD use. o All the above details where they relate to a single person. o The results of performance reviews or action plans for improving performance if this related to the management of controlled drugs. A formal review of the contents of each file will be undertaken by the AO or a person designated by them on a regular basis, and ideally at least once a year. 6.3.3 Managing concerns, complaints and poor performance This section should be read in conjunction with the PCT Serious Untoward Incident Policy. The handling of CD related concerns, complaints and poor performance will be in line with this policy. The additional processes to be followed for controlled drugs related concerns are outlined in appendix H. The investigating officer for any concern under investigation must have a sufficient understanding of CD management to conduct informed lines of enquiry during the course of the investigation. Care should also be taken to preserve any evidence that may be required in the future for a criminal or fitness to practice investigation. When necessary, information that may be pertinent to an investigation can be requested from some or all of the members of the Local Intelligence Network or the PCT AOs of other LINs across the country, this includes the Police where the information held on police databases will not interfere with ongoing investigations if released to CD AOs – any such information released will be on a strict and confidential basis to assist with ongoing investigations / concerns. Targeted inspections to support an investigation may be carried out by persons designated by the AO and may be carried out in any premises as necessary to provide information relevant to the case, this right of entry and inspection is provided for within the Health Act 2006. Wherever possible, where the premises to be inspected would have a routine inspection carried out by another organisation, the visit will be conducted jointly with the other organisation concerned. For example, a targeted inspection of a community pharmacy would normally be conducted with the Royal Pharmaceutical Society Chemist Inspector. A targeted inspection will not normally be notified in advance to the practitioners concerned and will be restricted to areas or activities that are pertinent to the nature of the investigation. On occasion it may be appropriate to conduct inspections / investigations jointly with the Police, the decision to do so lies with the AO, and will be based upon the seriousness of individual cases. Where a concern is raised about providers of private healthcare that are not also providers of NHS care the PCT will undertake the preliminary stage and if necessary stage 1 of the performance management process. However any enduring causes for concern resulting from this will be referred either to the Healthcare Commission (if the provider is registered with them) or the professional’s regulatory body. If appropriate, the professional concerned will also be directed to seek advice from their professional representative bodies or indemnifying bodies. 6.3.4

Managing patient safety incidents Patient safety incidents involving CDs will be dealt with as per the PCT Incident Reporting & Management Policy but with involvement of the AO (or a person delegated by them to

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represent the interests of the AO) in any investigation that is undertaken as a result of the incident report. The investigating officer of any incident must have access to a professional with sufficient understanding of CD management to make informed decisions during the course of the investigation. Only in exceptional circumstances would a targeted CD inspection form part of an incident investigation outside of a wider investigation of a cause for concern. The outcome & learning from any investigation will be shared with members of the local intelligence network. 6.3.5

Calderdale, Kirklees and Wakefield Local Intelligence Network (LIN) The remit of the Calderdale, Kirklees and Wakefield Local Intelligence Network is to: 1. Comply with the duty of collaboration as defined by the Health Act 2006 (and related regulations) with regard to identifying and resolving issues of a. poor management of controlled drugs b. poor clinical/professional handling or use of controlled drugs. 2. To act as a forum for the dissemination of best practice in the management of controlled drugs. A framework for the operation of the LIN is provided in Appendix I The PCT will support the operation of the LIN and provide a resource for maintenance of a database of LIN members. The PCT will also undertake to test the information sharing processes on a periodic basis.

6.3.6

Occurrence reports The AO of the PCT will collate occurrence reports provided on a quarterly basis by all the AOs of the other organisations within the local intelligence network / PCT area. Organisations that are members of the LIN but do not have an AO are not required to submit a report. The occurrence reports must describe details of any concerns that the organisation has regarding the management of CDs or confirmation that there are not or have not been any concerns raised in the time period to be reported. These will be submitted on the approved Occurrence reporting pro-forma (see appendix J). In addition the AO of the PCT will request that the report contains a summary of any concerns that were raised but subsequently resolved. Such reports will be provided in such a manner as to protect the identity of the individuals concerned. In order to receive information on concerns raised within community pharmacy the AO of the PCT will request an occurrence report from the representative of the Royal Pharmaceutical Society of Great Britain who is a member of the LIN. Occurrence reports will be reviewed by the AO of the PCT or a person delegated by them to do so. The purpose of this review is to cross reference those concerns managed within each organisation with others within the local intelligence network and to ensure that the appropriate action has been taken by the reporting organisation in relation to its active duty to share information.

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6.4 Confidentiality & Information Governance Information is to be stored pursuant to and compliant with the principles of the Data Protection Act 1998. However, there are circumstances when information needs to be shared with other bodies and the regulations specify circumstances in which information can / should be shared. In these circumstances consent to share information is not required by virtue of Schedule 2 of the Data Protection Act 1998. Other rights under the Data Protection Act such as subject access continue to apply. Data which applies to an individual is excluded from the remit of the Freedom of Information Act 2000. Information about good CD Management will be kept on file as well as information about poor CD Management Practitioners are not necessarily notified every time information is entered into his/her file, depending upon the type of information. Non-validated and anecdotal information will not be stored unless it is very clearly identified as such, in which case its relevance is markedly diminished. However, where several sources of independent information raise the same issues / concerns, the relevance of the information will increase. Practitioners are able to view the information held about them on file. It may be necessary to protect the identity of other parties when information is being viewed. The PCT will similarly be mindful of the need to maintain confidentiality in the case of whistle-blowing incidents. The PCT may decide to withhold information during the course of an investigation if the release of such information may jeopardise the collection of evidence, hinder an ongoing investigation, adversely affect the safety of patients, or the well-being of other staff. CD files will be used to: •

Build a chronological database of validated CD management information

Substantiate and construct trend analysis in cases of recurrent patterns

Store related correspondence, including that to and from Professional Regulatory bodies

Substantiate information given whenever a reference is issued for a Practitioner

Provide evidence to NHS, Investigative, and Statutory bodies as deemed necessary for the protection and safety of the Public

Present validated information to the PCT Performance Advisory Group as necessary in respect to practitioners for whom the PCT is responsible, to ensure a PCT corporate response and management plan for the PCT and practitioner concerned.

To provide information to members of a Local Intelligence Network in such a format as to aid in an investigation or the operation of an incident panel.

CD files relating to individual practitioners may be passed on to other AOs at their request should a practitioner move from the PCT list onto the list of another PCT, NHS trust or private healthcare provider. Files relating to an individual’s controlled drugs management will remain active for the duration of time the practitioner continues to practice within the PCT. The files will be archived once the practitioner ceases to practice in the PCT and retained for a period of 25 years to provide evidence if required in any future litigation or investigation which may be brought.

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6.5

Controlled drugs registers and records

The PCT expects all practitioners who hold stock of controlled drugs to maintain a controlled drugs register that complies with the Misuse of Drugs Regulations 2001 and its subsequent amendments. It also expects all persons administering controlled drugs to make appropriate records of their actions in line with the NMC (2006) Advice Sheet on Record Keeping and to comply with any such legislation as is published in the future relating to the Patient Drug Record Card (PDRC) or other such record keeping system. Any person collecting or transporting CDs on behalf of a patient must ensure that they have provided sufficient information to the supplier of the CD as to create a robust audit trail of their activities. This will include providing dispensing pharmacies with evidence of the collecting person’s identity. 6.6 Destruction of Controlled Drugs The PCT will maintain such contracts and/or facilities as to ensure that patients and health professionals are able to dispose of CDs, as this becomes necessary, in line with HTM 07-01: Safe Management of Healthcare Waste. All drugs which are patient’s own CDs must be returned to a pharmacy for destruction with the exception of patients who are in Care Homes with Nursing. Such establishments should have their own procedures and facilities for disposing of patient’s own “returned” CDs. Stock CDs can be destroyed by the person in possession of them but this must only be done in the presence of an authorised witness. The authority to witness (but not to destroy) CDs must be obtained from the Secretary of State for Health or the Home Secretary. This authority currently allows PCT Medical Directors, the PCT’s most senior pharmacist and any person who is answerable to an executive director of the PCT to witness the destruction of Stock CDs. Additional authorisations can be made by, or requested from the Home Secretary at any time. The PCT AO may authorise individuals as witnesses for the purpose of witnessing the destruction of CDs, for this purpose, the individuals concerned will report directly to an Executive Director of the PCT, and / or the PCT AO. The AO will maintain a list of persons within the PCT who have both the necessary authority invested by the Secretary of State for Health and whom are also approved to carry out this function by the PCT AO. The AO or a person designated by the AO, must be informed of any destruction of stock CDs by PCT staff and an entry must be made in the practice’s or practioners CD file. No person may witness the destruction of CDs that have been in their possession or in the possession of a premises in which they work. The AO may not destroy or witness the destruction of CDs.

6.7 Developing services that utilise controlled drugs PCT employees who are involved in service development or service planning must be mindful of developments that may involve the use of CDs. Whenever a change is planned to be made to primary care services, that is anticipated could start, stop or change the way in which CDs are used the AO must be informed, in writing or by e-mail, prior to the changes becoming operational. Any such changes to services must also be incorporated into Standard Operating Procedures for that service. Controlled Drugs Policy for NHS Kirklees

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6.8 Provision of advice, guidance and training The PCT will endeavour to promote “best practice” in the management and use of controlled drugs wherever possible. The PCT will provide textual guidance to staff and practitioners to ensure that they have access to the most up-to-date information within a reasonable time of its publication, this includes example Standards Operating Procedures (SOPs). The PCT will also provide advice and guidance to any member of staff or primary care practitioner who requests it. Controlled drugs training is provided as part of the PCT mandatory training programme for KCHS staff as a section within the medicines management mandatory training identified within the programme. Where additional CD training requirements are identified, the PCT endeavor to commission / provide this to assure that every member of staff and practitioners providing NHS primary care have access to training on CDs.

7.

Equality Impact Assessment

All public bodies have a statutory duty under the Race Relation (Amendment) Act 2000 to “set out arrangements to assess and consult on how their policies and functions impact on race equality.” This obligation has been increased to include equality and human rights with regard to disability age and gender. The Trust aims to design and implement services, policies and measures that meet the diverse needs of our service, population and workforce, ensuring that none are placed at a disadvantage over others. In order to meet these requirements, a single equality impact assessment is used to assess all its policies/guidelines and practices. This Policy/procedure/guidance (delete as appropriate) was found to be compliant with this philosophy (see appendix C). 8.

Training Needs Analysis

Controlled drugs training is provided as part of the PCT mandatory training programme for KCHS staff as a section within the medicines management mandatory training identified within the programme. Additional training needs to be made available for: • Contractors who handle or manage CDs • Non-medical prescribers who prescribe CDs • Care homes and their staff, where CDs are stored and administered on site. Whilst it is the employers responsibility to ensure staff employed by them have received the appropriate training, the PCT has a duty through the office of the AO to ensure training is provided and to a suitable standard for the safe and effective management of controlled drugs. Any addition additional training needs identified in the course of implementing this policy will be commissioned by the PCT as necessary to fulfill statutory and best practice requirements.

9.

Monitoring Compliance with this policy 1. Named Accountable Officer identified, and registered with the Health Care Commission / Care Quality Commission. 2. Controlled Drugs Local Intelligence Network continues to meet quarterly, (minutes of meetings) 3. Receipt of Controlled Drugs Quarterly Occurrence reports from all organisations.

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4. Controlled Drugs Statutory returns available for all contractors and providers of services. 5. Number of Controlled Drugs Inspection reports available indicating compliance levels against monitoring / inspection standards. 6. Action plans for variances from the policy 7. Audit of compliance against legal and best practice guidance 8. Availability of regular Controlled Drugs Prescribing reports. 9. Processes for witness of CD destruction, and records of witness to CD destruction by PCT officers authorized by the PCT Controlled Drugs Accountable Officer 10. Provision of legal and best practice guidance. 11. Number of mandatory training sessions available to staff 12. Number of staff attending mandatory training programme

10.

References and further reading

A Guide to good practice in the management of controlled drugs in primary care (England): Second edition; February 2007, National Prescribing Centre http://www.npc.co.uk/controlled_drugs/CDGuide_2ndedition_February_2007.pdf Health Act 2006 http://www.opsi.gov.uk/acts/acts2006/20060028.htm Misuse of Drugs Regulations 2001: Statutory Instrument 2001 No 3998 www.opsi.gov.uk/si/si2001/20013998.htm Misuse of Drugs (Amendment) Regulations 2005: Statutory Instrument 2005 No 0271 www.legislation.hmso.gov.uk/si/si2005/20050271.htm Clinical Governance Toolkit for Controlled Drug Management in Primary Care in the NHS. Clinical Governance Support Team. Leicester. Accesses Jan 2007 www.cgsupport.nhs.uk/downloads/Primary_Care/CG_toolkit_for_controlled_drug_management.pdf Controlled Drugs in the community. A guide for General Practice. Clinical Governance Support Team. Leicester. October 2005 www.cgsupport.nhs.uk/downloads/Primary_Care/controlled_drugs_in_the_community.pdf The safe and secure handling of medicines: a team approach. A revision of the Duthie Report (1988). RPSGB March 2005 www.rpsgb.org.uk/pdfs/safsechandmeds.pdf Final guidance — Safer management of controlled drugs: changes to record-keeping requirements. DH October 2006 www.dh.gov.uk/assetRoot/04/13/97/02/04139702.pdf Safer management of controlled drugs: (1) guidance on strengthened governance arrangements. DH January 2007 www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsP olicyAndGuidanceArticle/fs/en?CONTENT_ID=4141666&chk=ATnhRu Safer management of controlled drugs: guidance on standard operating procedures for controlled drugs. DH January 2007 Controlled Drugs Policy for NHS Kirklees

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www.dh.gov.uk/assetRoot/04/14/25/63/04142563.pdf Safer management of controlled drugs: private CD prescriptions and other changes to the prescribing and dispensing of controlled drugs. DH July 2006 www.dh.gov.uk/assetRoot/04/13/67/30/04136730.pdf Interim guidance — safer management of controlled drugs: guidance on the destruction and disposal of controlled drugs. DH October 2006 www.dh.gov.uk/assetRoot/04/13/97/03/04139703.pdf Controlled Drugs (Supervision of Management and Use) Regulations 2006: Statutory Instrument 2006 No 3148. http://www.opsi.gov.uk/si/si2006/20063148.htm Controlled drugs: Monitoring and inspection guidelines – Core activities for CD monitoring and inspection work – primary care. Department of Health 27th March 2006 http://www.dh.gov.uk/assetRoot/04/13/22/58/04132258.pdf Ensuring safer practice with high dose ampoules of diamorphine and morphine. National Patient Safety Agency, Safer Practice Notice 25 May 2006 http://www.npsa.nhs.uk/site/media/documents/1789_Diamorphine_SPN.pdf Reducing dosing errors with opioid medicines: National Patient Safety Agency, Rapid Response Report NPSA/2006/RRR05. http://www.npsa.nhs.uk/patientsafety/alerts-anddirectives/rapidrr/ Guidance for pharmacists on the safe destruction of controlled drugs England, Scotland and Wales. RPSGB www.rpsgb.org.uk/pdfs/cdsafedestructionguid.pdf Improving Patients’ Access to Medicines: A Guide to Implementing Nurse and Phamacist Independent Prescribing within the NHS in England. Department of Health April 2006. http://www.dh.gov.uk/assetRoot/04/13/37/47/04133747.pdf Health Technical Memorandum 07-01: Safe Management of Healthcare Waste. Department of Health, London. November 2006. http://www.dh.gov.uk/assetRoot/04/14/08/93/04140893.pdf

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11.

Appendices A. Definitions

PCT AO

NHS Kirklees (Primary Care Trust) The PCT Accountable Officer (unless otherwise specified) CD AO The PCT Controlled Drugs Accountable Officer (unless otherwise specified) e-PACT Electronic Prescribing Analysis and CosT data CD Controlled Drug as defined by the Misuse of Drugs Act 1971 LIN The Local Intelligence Network for Calderdale, Kirklees and Wakefield Practitioner A health professional providing Healthcare services Contractor A person or persons contracted to provide primary care health services Schedule 2,3,4 or 5 Controlled drugs Schedules as defined by the Misuse of Drugs Regulations 2001 (as amended) The Health Act 2006 The paragraphs contained in Chapter 1of Part 3 of the Act; “Supervision of management and use of controlled drugs� CSCI Commission for Social Care Inspection SHA Strategic Health Authority (Yorkshire & Humber NHS) RPSGB Royal Pharmaceutical Society of Great Britain MAR Medication Administration Record Chart DTTO Drug Treatment and Testing Orders NMC Nursing & Midwifery Council HTM Health Technology Memorandum SOP Standard Operating Procedure QOF The Quality and Outcomes Framework of the new General Medical Services Contact PAG Performance advisory Group LMC Local Medical Committee LOC Local Optometric Committee LDC Local Dental Committee LPC NHS PDRC

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Local Pharmaceutical Committee National Health Service Patient held record card

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B. Key stakeholders consulted/involved in the development of the policy/procedure

Stakeholders name and designation Neill McDonald – CD Accountable Officer (Assistant Director of Medicines Management & Prescribing) Terry Service – Assistant Director of Corporate Services & Risk Sheila Dilks – Director of Patient Care and Professions Sue Smith – Assistant Director of Clinical Governance & Quality Lucianne Ricketts – Senior Medicines Management Advisor – Strategic & Operational development Chris Toothill – Clinical Governance Lead for Community Pharmacy Lisa Meeks Professional Executive Committee members Medicines Management Committee members Gwen Ruddlesdin (KCHS)

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Key Participant Yes/No

Feedback requested Yes/No

Feedback accepted Yes/No

Yes (author)

-

-

Yes

Yes

Yes

No

Yes

-

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes Yes Yes Yes

Yes Yes Yes Yes

Yes Yes Yes -


C. Equality Impact Assessment Tool To be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval. Insert Name of Policy / Procedure Yes/No 1.

Comments

Does the policy/guidance affect one group less or more favourably than another on the basis of: • Race

No

Policy applies equally to all groups

• Ethnic origins (including gypsies and travellers)

No

Policy applies equally to all groups

• Nationality

No

Policy applies equally to all groups

• Gender

No

Policy applies equally to all groups

• Culture

No

Policy applies equally to all groups

• Religion or belief

No

Policy applies equally to all groups

• Sexual orientation including lesbian, gay and bisexual people

No

Policy applies equally to all groups

• Age

No

Policy applies equally to all groups

No

Policy applies equally to all groups

Policy applies equally to all groups

• Disability - learning disabilities, physical disability, sensory impairment and mental health problems 2.

Is there any evidence that some groups are affected differently?

No

3.

If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable?

No

4.

Is the impact of the policy/guidance likely to be negative?

No

5.

If so can the impact be avoided?

N/A

6.

What alternatives are there to achieving the policy/guidance without the impact?

N/A

7.

Can we reduce the impact by taking different action?

N/A

Improved governance and improved patient safety for CD management

If you have identified a potential discriminatory impact of this procedural document, please refer it to [insert name of appropriate person], together with any suggestions as to the action required to avoid/reduce this impact. For advice in respect of answering the above questions, please contact [Neill McDonald, Controlled Drugs Accountable Officer- tel No 01484 344343].

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