Workplan for implementing new arrangements for Safe Management of

By Dean Johnson,2014-04-15 15:25
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Workplan for implementing new arrangements for Safe Management of

    NHS Brent

    Work Plan for Implementing New Arrangements for Safe

    Management of Controlled Drugs

1. Background

    The PCT is responsible via the Accountable Officer (AO) for the secure and safe management and use of Controlled Drugs (CDs) in its organisation and within local organisations subject to its oversight.

Responsibilities include:

    ; Establishing arrangements for sharing information by setting up a Local Intelligence

    Network (LIN)

    ; Monitoring and auditing the management and use of Controlled Drugs within

    independent organisations via the occurrence reporting process

    ; An Incident Reporting Process in place and maintaining appropriate records. The

    incidents are followed through and actions taken as appropriate. The incidents are

    also discussed at the LIN meeting and the record is updated to account for open

    and closed cases.

    ; Maintaining a record of concerns regarding relevant individuals and discussing

    these at the LIN meeting

    ; Assessing and investigating incidents/concerns

    ; Taking appropriate action if there are well founded concerns

    ; Ensuring adequate destruction and disposal arrangements are in place ; Ensuring arrangements are in place to monitor and audit the management and use

    of Controlled Drugs

2. Progress in 2008/2009

    During 2008/09, the Medicines Management team continued to support the implementation of the safer management of Controlled Drugs (CDs) in accordance with the Controlled Drugs (Supervision of Management and Use) Regulations 2006 and the Accountable Officer in her role. Progress against the agreed work plan (to date) can be seen in Appendix A.

Progress in five key areas is outlined below:

    3.1 Establishing arrangements for sharing information by setting up a

    Local Intelligence Network

    ; In February 2009 a Local Intelligence Network (LIN) covering Brent was established.

    The current Draft Terms of Reference are attached in Appendix B. Two LIN

    meetings have taken place to date.

     The NHS Brent is also part of the North West London CD network which met 4 ;

    times in 2007/2008 and once in 2008/2009 (to date).

    3.2 Monitoring and auditing the management and use of Controlled

    Drugs within independent organisations via the occurrence

    reporting process

    ; A process has been implemented for collating and analysing quarterly occurrence

    reports from relevant organisations.

    ; Since 2007/2008, CD Occurrence Reports have been requested from the

    Accountable Officers for 3 organisations required to submit them (NWLH T, CNWL

    Mental Health Trust and St Luke’s Hospice). The reports are logged and any

    concerns are followed up by the Accountable Officer.

    June 09

    NHS Brent

    ; In 2008/09, a concern was raised by St Luke’s Hospice, which was duly

    investigated and acted upon and the case is now closed.

3.3 Concerns regarding Controlled Drugs

    ; In 2007/2008, a CD concerns log was put in place. All concerns reported by

    external agencies or any independent contractors or members of staff or public

    were logged and appropriate action taken and recorded.

     A process for investigating concerns was approved by the Prescribing and ;

    Medicines Management Committee and the LMC and ratified by the Board in Feb


    ; In 2007/2008, the PCT received 2 concerns which have been acted upon and the

    cases are now closed.

    ; In 2008/2009, no concerns were reported (except via Occurrence report-see 3.2) ; The status of the concerns at May 2009: No outstanding concerns

    Intelligence sharing with external agencies had resulted in the investigation of an

    NHS Brent GP who was also registered with Brent as a private prescriber for

    controlled drugs. These concerns were forwarded to the practitioner performance

    function in the PCT. After further review, no serious concerns were found.

    Additional support was provided to the GP to audit her practice and her practice

    was deemed satisfactory. She subsequently resigned from substance misuse

    management as she felt unsupported. The PCT is reviewing how it adequately

    supports practitioners in this area.

    3.4 Ensuring adequate Destruction and Disposal Arrangements are in

    place in Brent

    ; Suitable arrangements with independent contractors have been put in place for the

    destruction and disposal of stock CDs. These arrangements have been approved

    by the Prescribing and Medicines Management Committee.

    ; PCT AO has authorised Prescribing Advisers members of the Prescribing and

    Medicines Management team to witness the destruction of CDs.

    ; Standard Operating Procedure (SOP) for the destruction of CDs was developed

    and has been approved by the Prescribing and Medicines Management Committee

    and the Prescribing Advisers all have their annual CRB checks done and have

    received training from the Metropolitan Police CD Liaison officer (CDLO) and Royal

    Pharmaceutical Society of Great Britain Professional Standards Inspector. There is

    a process in place for liaising between the Prescribing Advisers and Metropolitan

    Police CDLO and Royal Pharmaceutical Society of Great Britain Professional

    Standards Inspector in case of any concerns/discrepancies raised whilst

    undertaking the witnessing of stock schedule 2 CDs in independent contractors.

    3.5 Ensuring Arrangements are in place to Monitor and Audit the

    Management and Use of Controlled Drugs

    ; Appointment of a dedicated Controlled Drugs Support Pharmacist to support the

    Accountable Officer as per the NHS regulations had been identified in January

    2007 and the request was made to the board in May 2007. As the PCT was in a

    turnaround situation, a resource for a dedicated pharmacist was not available. ; Since the implementation of the strengthened governance regulations, the workload

    for the Support Pharmacist has increased significantly and the need for a dedicated

    Pharmacist to support compliance with the legislation is a priority. Moreover this

    statutory function is part of the World Class Competency (WCC) and appropriate June 09

    NHS Brent

    resource for this post needs to be identified and agreed by the board. The current

    CD Support Pharmacist is also a Prescribing Adviser and will be working with

    supporting practices with Practice based Commissioning under a SLA from 09-10

    with Wembley cluster.

    ; In May 2007, a work plan for implementing the new arrangements for safe

    management of CDs was approved by the Brent PCT Board.

    ; Systems have been put into place to monitor the use of CDs in the NHS and private


    ; Systems have been put in place to collate Annual Self Assessment and Declaration

    (SAD) forms as required of the Regulations. SAD forms for the last 2 financial years

    have been sent to all GP and dental practices contracted with the PCT. ; Providers and contractors that hold stocks of CDs are required to work to an

    appropriate Standard Operating Procedure (SOP). SOPs developed across North

    West London were circulated to NHS GPs and dentists and private providers for

    adaptation for use in practice.

    ; For Brent Community Services as a provider, the PCT must ensure appropriate

    SOPs are in place. As such, the management of CDs forms part of the Brent

    Medicines Policy and there is an approved Controlled Drugs Policy in place in Brent.

    3.6 Other areas (Requisitions for the supply of Schedule 1, 2 and 3 CDs and Record keeping arrangements)

    ; The Prescribing and Medicines Management team has successfully managed the

    implementation of the changes to the requirements for requisitions for the supply of

    Schedule 1, 2 and 3 CDs in January 2008 and the changes to record keeping

    arrangements in February 2008.

    ; Advice and support has been provided to providers, including the safe and effective

    prescribing of CDs. Changes in CD regulations and governance arrangements have

    been communicated via update letters, newsletters, etc to NHS GP practices, NHS

    Dental practices, community pharmacies and private prescribers.

4. Priorities for 2009/2010

    Priorities for 2009/10 based on the work plan and gaps identified to date from the Care Quality Commission (CQC) Controlled Drugs governance self-assessment tool are as follows:

    1. To analyse all Annual Self Assessment and Declarations from NHS GP and

    Dental Practices and identify practices/areas of concern and the need for

    education and training

    2. To adapt and agree a data sharing agreement for the LIN, once developed

    across the North West London sector

    3. To plan routine CD inspection visits for a sample of NHS GPs and dentists that

    stock CDs

    4. To complete the CQC Controlled Drugs governance self-assessment tool

Versha Varsani, Prescribing Adviser & Support Pharmacist for Controlled Drugs

    Rashmi Rajyaguru, Head of prescribing & Medicines Management and Accountable Officer for thControlled Drugs 13 July 2009

    June 09

    NHS Brent


    Work Plan for Implementing New Arrangements for Safe Management of Controlled Drugs

    Action Current Progress Further Action

    1. PCT Accountable Officer Function

    1.1 Appoint a CD Accountable Officer No further action ; Rashmi Rajyaguru (RR), Head of Prescribing and Medicines

    Management appointed and Care Quality Commission (formerly

    known as Healthcare Commission) notified at Jan 07.

    ; RR has the line of Accountability regarding Controlled Drugs

    (CDs) to Dr Alex Jamieson (AJ), Medical Director who in turn

    has the line of Accountability to the Board.

    ; AJ is the Medical Professional Support and link to the Decision

    Making Group and Performance Committee.

    1.2 Identify support for the Accountable ; Delegated support responsibility to Versha Varsani (VV), ; Since the implementation of Officer Prescribing Adviser. the strengthened

    governance regulations, the ; VV & Prescribing and Medicines Management Team (PMMT)

    workload for the CD Support are responsible for data analysis and carrying out any initial

    Prescribing Adviser has investigations as necessary.

    increased significantly and ; RR is responsible for setting up and running the Local

    the need for a dedicated Intelligence Network (LIN) This comprises of the following

    Pharmacist to support agencies:

    compliance with the Care Quality Commission

    legislation has been Metropolitan Police

    identified. Royal Pharmaceutical Society of great Britain (RPSGB)

    ; This statutory function is part NWLH T

    of the World Class CNWL Mental Health Trust

    Competency framework. Local Counter Fraud Specialists

     Local Security Management Specialists

     Substance Misuse Management Project

June 09

    NHS Brent

    Action Current Progress Further Action

    1.3 Agree relevant systems for No further action ; Incident Reporting Process involving CDs in place and relevant performance management within logs are maintained to account for open and closed cases

    existing local structures ; Reporting of CD Concerns process in place and relevant logs

    are maintained to account for open and closed cases

    ; Processes for investigating concerns approved by Prescribing &

    Medicines Management Committee (PMMC) and agreed by the

    Board in Feb 09

    ; The above cases are discussed at the LIN meeting as of Feb 09

    (previously discussed with agencies concerned). The medical

    Director subsequently presents appropriate cases to the

    Decision Making Group

    2. Routine Monitoring

    2.1 Monitor the use of Controlled Drugs Quarterly CD Monitoring Report is produced by the delegated CD To continue routine monitoring through routine processes such as Support Prescribing Adviser. The report is presented to the

    data analysis, and audit, as an Prescribing and Medicines Management Committee (PMMC) and

    integral part of normal clinical CD LIN. The report monitors the following in detail as per the

    governance arrangements where Statutory requirements:

    appropriate. ; Prescribing by NHS GPs

     Quarterly monitoring and follow up of NHS GP CDs is in place

     since April 2006 (as per Prescribing Support Unit CD Monitoring


    ; Prescribing by Nurse Prescribers

    Quarterly monitoring and follow up of Nurse Prescribing of CDs

    is in place since April 2006

    ; Prescribing by Private Prescribers

    Quarterly monitoring of private CD prescribing in place from July


    ; Requisitions

    Monitoring of CD requisitions (forms for obtaining stock CDs for

    GPs, dental practices and community pharmacists)

    incorporated into the current monitoring process since Jan 08.

    All the above monitoring information will be archived for a

    minimum of 7 years.

    June 09

    NHS Brent

    Action Current Progress Further Action

    2.2 Ensure the PCT and its contractors NHS Brent AO has authorised Prescribing Advisers to witness Maintenance of safe destruction have suitable arrangements in destruction of stock CDs following recent change in regulations as of in independent contractors as place for the disposal of Controlled August 2007. and when requested.

    Drugs Destruction SOP (version 2) for Prescribing Advisers approved by

    PMMC in March 2009 in place. This SOP is also signed by the

    authorised Prescribing Advisers to ensure governance in place.

    Ensured that the NHS Brent Prescribing Advisers have received

    adequate training and are kept up to date (shadowed inspector visits,

    CRB checks)

    2.3 Ensure that systems are in place to Identify triggers through links with the following: Completed

    identify and act on triggers such as ; PALS/Complaints (CDs related)

    patient incidents, police intelligence ; Incident reporting (CDs related)

    or a healthcare professional raising ; Quarterly Report ; Occurrence reporting by NWLHT, CNWL and St Luke’s Hospice

    a concern. ; Police and regulatory bodies

    ; Alerts for stolen prescriptions

    2.4 Put in place systems to adapt (from ; 08-09 SAD forms for Schedule 2 and 3 activities have been sent ; Follow up on outstanding Care Quality Commission to all GP and dental practices and those private prescribers who SAD forms from GP and template) , circulate and collate are not registered as NHS Brent GPs or Dentists. Dental Practices

    Annual Self Assessment and ; Analysis of these submitted SAD forms and the appropriate ; To agree action with the Declaration (SAD) as required per actions will be taken in 09-10 Medical Director regarding the Regulations non responders after two

     follow up letters

    ; Analyse all SAD forms and

    identify practices/areas of

    concern, need for education

    and training, etc.

    ; SAD will help inform other

    monitoring and inspection


    2.5 Advise Community Services and Community Services

    independent Contractors that use Completed ; PCT Commissioners have been advised to include the Controlled Drugs(CDs) that they are requirement to work to appropriate CD Standard Operating required to work to appropriate Procedures for Community Services in 09-10 annual contracts

    Standard Operating Procedures (Feb 09)

    June 09

    NHS Brent

    Action Current Progress Further Action

    Independent Contractors

     ; Standard Operating Procedures (SOPs) developed for

     independent contractors across North West London sector,

     agreed at September 07 PMMC and endorsed by LMC.

     ; Circulated to NHS GPs (March 08) and dentists

     (July 08) and private prescribers (March 08) to adapt for local


     Management of Controlled Drugs by Community Pharmacists

    ; PCT Contract team are ; Pharmacy Contract now has a mandatory requirement for

    responsible for monitoring pharmacists to have a Standing Operating Procedure (SOP) for

    compliance through the dealing with CDs

    annual essential services ; AO has sent letter to all Brent pharmacies reminding them of the

    declaration required from all key concerns raised by the RPSGB Inspector

    pharmacies as part of

    contract monitoring as part of

    the existing governance

    ; Controlled Drugs SOPs

    implementation should be an

    area for discussion at the

    contract monitoring visits to

    pharmacies by the Contract


    ; CD Inspection reports

    following visits by RPSGB

    Inspector should be followed

    up with individual contractors

    where concerns with regard

    to management of controlled

    drugs are raised.

    2.6 Carry out a formal review once a ; Concerns are recorded along with action taken and reviewed at To formalise process

    year of primary care providers each Brent Local Intelligence Network meeting.

    based on benchmark analysis ; RPSGB inspectors report incidents and send copies of derived from existing information, inspection reports to NHS Brent AO to be cross-referenced on

    including the organisation’s Self concerns log.

    Assessment Declaration form,

    June 09

    NHS Brent

    Action Current Progress Further Action

    concerns and reports from any

    routine visits by Prescribing

    Advisers and/ or clinical governance

    leads. The review can be part of

    existing clinical governance


    3. Routine Inspections

    3.1 Arrange routine inspections of a ; To date, 2 Dental Sedating practices which stock and administer ; GP and Dental Practice visits random sample of those GP and CDs for NHS activity have been visited by the Prescribing outstanding.

    Dental Practices and other Adviser in conjunction with the Dental Adviser ; Targeted visits to GP and contracted primary care providers ; RPSGB inspectors inspect community pharmacies. The PCT has dental Practices are to be where Controlled Drugs are stored received 49 Community pharmacy CD inspection reports from planned following submission dispensed, supplied or used on the the RPSGB to date. of the CD SAD forms.

    premises*. Visits should normally

    be announced and can be

    combined with other visits.

    NB *RPSGB inspectors inspect

    community pharmacies

    3.2 Provide advice and support to Identify education and training ; Changes in CD regulations and governance arrangements have providers, including the safe and needs of those involved in been communicated via update letters, newsletters, etc to NHS effective prescribing of Controlled Controlled Drugs GP practices, NHS Dental practices, private prescribers and Drugs. community pharmacies.

    ; Education & training workshops have been provided to Brent

    community pharmacists in Spring 2008

    ; Further 4 workshops to local community pharmacists have been

    delivered in Summer 08.

    ; Presentation on the role of an AO has been delivered to the

    Community Services Directorate in Jan 09

    ; SOP for management and use of CDs has been developed and

    distributed to NHS GP and dental Practices and private

    providers, to adapt for local use.

    ; Prescribing Advisers update prescribers and practice staff during

    practice visits

    June 09

    NHS Brent

    Action Current Progress Further Action

    4. PCT as a Provider

    4.1 Ensure appropriate SOPs are in Completed ; Management of Controlled Drugs is part of the Medicines Policy,

    place which has been reviewed and ratified.

    ; Refer to 2.5 above

    4.2 Provide evidence for completion of Evidence submitted for 2008/09 HCC declaration Completed

    the CD related aspect of section

    C4d of the PCT Standards for

    Better Health submission to the

    Care Quality Commission

    5. Information Sharing

5.1 Establish and operate a LIN giving Data sharing agreement to be ; Local Intelligence Network to cover Brent has been established

    regard to ensuring that the duty of discussed and agreed with LIN and draft terms of reference are awaiting approval.

    collaboration is active and complied members ; All LIN members have been determined and are attending

    with as detailed in the legislation meetings

    and guidance. ; NHS Brent is also is part of the North West London CD network,

    established since March 07 and meets quarterly. Minutes are

    shared with Brent LIN members

    5.2 Manage a process for collating and Completed. ; Quarterly Occurrence reports have been requested from the

    analysing quarterly occurrence Accountable Officers (AO) of NHS Trusts (NWLH T & CNWL)

    reports from relevant organisations and St Luke’s Hospice, who are required to submit them to the

    Lead PCT (Brent).

    ; The occurrence reports are logged and information analysed and

    reported at LIN meetings.

    ; Any concerns reported are investigated and followed through.

    ; Any outstanding reports are chased up.

    6. Investigating Concerns

6.1 Ensure robust systems are in place Completed ; All CD concerns are reported to RR and/or VV and/ or the

    to enable concerns about Medical Director. These are logged and appropriate action taken

    Controlled Drugs to be raised, to log and recorded.

    these concerns and to agree ; A document on Managing Concerns has been developed across

    triggers to initiate investigations, NWL PCTs and agreed by Board Feb 09

    where appropriate

    June 09

    NHS Brent

    Action Current Progress Further Action

    7. Training and Development of staff involved in Controlled Drugs

    Identify and support training and A file of supporting guidance has been established Consider adding to Prescribing development needs of staff dealing with team’s Personal Development Controlled Drugs. plans

     Data from Self Assessment Declaration will inform future support and Review DH guidance which

    training needs for practice. Identify, plan and implement training details

    training & development sources

    already available and being


    June 09

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