Gateshead Medicines Management Committee

Terms of Reference

Authority

The Gateshead Medicines Management Committee is the recognized decision-making body for all aspects of medicines management across primary and secondary care within Gateshead with delegated powers from both Gateshead CCG and Gateshead Health NHS FoundationTrust.

It will report to NHS Gateshead Clinical Commissioning Group and Gateshead Health NHS Foundation Trust Business Services Development Committee.

Aim

The aim of the committee is to work collaboratively across primary and secondary care to ensure the optimum use of evidence-based cost-effective medicines management within Gateshead.

Membership

A.Substantive Members of Committee

3 Secondary Care Prescribersnominated by Medical Director

(suggested disciplines = medicine/elderly, paediatrics, anaesthetics)

Board member – Prescribing Lead,

Gateshead Clinical Commissioning Groupnominated by Gateshead CCG

2 Primary Care Prescribers (e.g. GP/Nurse)nominated by Gateshead CCG

Chief Pharmacist,

Gateshead Health NHS Foundation Trust

Prescribing Advisor, Gateshead Locality Leadnominated by Gateshead CCG from NECS

Medicines Governance Pharmacist,

Gateshead Health NHS Foundation Trust

Lead Pharmacist Oncology & Aseptic Services,

Gateshead Health NHS Foundation Trust

Prescribing Interface Lead Pharmacist,

Northumberland, Tyne & Wear Mental Health Trust

Community Pharmacistnominated by LPC

Prescribing representative,

Gateshead Community Servicesnominated by STFT Community Health Services

NHS Gateshead CCG Commissioning Managernominated by CCG

Commissioning Manager,

Gateshead Health NHS Foundation Trust nominated by GHNFT

LMC representative(under review)nominated by LMC

Regional Drug & Therapeutics Centre (Newcastle) adviser

Primary Care Medicines Management Providernominated by MM provider

A patient representative from the appropriate patient group will be co-opted onto the committee for specific agenda items if the Committee feels this appropriate and will help with the decision to be made.

It is the responsibility of participating organisations to ensure they are adequately represented with deputies attending meetings where appropriate.

To be a quorum each meeting should have the following representation present:

  • chair or vice-chair
  • 1 x Secondary Care consultant
  • 1 x Primary Care prescribing representative
  • 1 x Secondary Care Pharmacist from GHFNT
  • 1 x Pharmacist from NECS Medicines Optimisation Team or NHS Gateshead CCG

No member may fulfill two above roles at the same meeting.

B.Support for Committee

Clinical support to be agreed & managed by GHFNT Pharmacy Manager & NECS Medicines Optimisation Team.

Secretarial supportcurrently provided by GHFNT, financially supported by NHS Gateshead CCG.

Tenure and Chairperson

The Chair and Vice Chair will be clinicians or pharmacists elected by the rest of the committee and one will be from Acute Trust and the other from Primary Care.

Officers may stand for re-election.

Conditions of Membership

Members must endeavour to send a representative or a deputy if they cannot attend.

Additional members may be co-opted as and when required.

Member’s current interests that might affect specific recommendations and/or decisions of the committee must be declared at the start of each meeting. These will be noted in the minutes. Members declaring a conflict of interest may be excluded from discussions/decision making (to be judged by the Chair), as appropriate.

Remit of Group

  • To implement the Medicines Optimisation strategy inGateshead including QIPP and primary care Medicines Optimisation Work Plan.
  • To be the mechanism for communication between primary and secondary care regarding issues involving medicines and their use.
  • To approve, based on the available evidence, the place in treatment locally of new drugs/formulations, or of new indications for existing drugs.
  • To be the mechanism for ensuring that the medicines related aspects of national guidelines and NICE are considered as part of local implementation processes and are incorporated in the development of prescribing guidelines.
  • To develop, maintain and monitor adherence to the local drug formulary.
  • To develop and maintain the local drug formulary on the NHS Gateshead CCG website and the Gateshead Health NHS Foundation Trust website. GHFNT is responsible for maintain the secondary car formulary and the Medicines Optimisation team for maintaining the primary care formulary.
  • To develop, implement and monitor adherence to local medicines management guidelines.
  • To identify, monitor & address (requesting audits where appropriate) variations in clinical practice, working with all appropriate stakeholders.
  • To monitor the financial implications of changes in prescribing practice, identify potential pressures and provide feedback to local clinicians and managers.
  • To make recommendations to assist in the resolution of problems relating to prescribing at the primary / secondary care interface.
  • To develop effective communication channels regarding prescribing issues and ensure advice is disseminated effectively to all stakeholders.
  • To provide a framework for effective medicines management within the clinical governance agenda.
  • To liaise with LMC and LPC as appropriate.
  • To inform the commissioning process to ensure that prescribing issues areincluded in wider health planning and local delivery plans via collaborative working with other designated decision making bodies for medicines.

Frequency of Meetings

Meetings will be held every two months.

Documents for meetings will be circulated to members at least one week prior to the meeting. A shorter period can be accepted in exceptional circumstances with prior agreement with the Chair & Secretary.

Decision Making

A ‘one member, one vote' system will operate. The Chair of the meeting has a casting vote, should there be an equal split. Members should agree to abide by the outcome of such votes. An affected party can make an appeal against a decision at a subsequent meeting.

If a meeting does not have a quorum all decisions/recommendations taken at that meeting must be ratified by the absent members prior to implementation via email.

Recommendations on decisions around New Drug Requests take into consideration safety, clinical effectiveness, and cost-effectiveness relative to other treatment options for the condition under discussion, as well as the potential available budget. Recommendations on decisions will be made on fully published trial data only. Abstracts or conference posters will not be used as the sole basis of a recommendation. Commercially agreed discount schemes will only be considered once a decision/recommendation based on clinical effectiveness is reached.

Participating organisations will need to ensure that they have appropriate corporate governance processes in place to ensure that the recommendations made by the GMMC are considered in the correct manner and endorsed as appropriate.

Further Guidance on the New Drug Request Decision Making Process

The process for the management of new drug requests for inclusion in the Gateshead Drug Formulary is laid down in Gateshead Health NHS Foundation Trust Medicines Management Policy MM04: Prescribing of Medicines.

In addition to the information provided by the consultant on the completed New Drug Request Form, relevant reviews from the following independent NHS sources of medicines information will be used to guide the members of the Gateshead Medicines Management Committee in reaching their decision:

  • London New Drugs (LNDG)
  • National Horizon Scanning Centre (NHSC)
  • National Prescribing Centre (NPC)
  • UK Medicines Information (UKMi)
  • Scottish Medicines Consortium (SMC)
  • NICE
  • Midland Therapeutic Review &

Advisory Committee (MTRAC)

  • Northern & Yorkshire Regional Drug &

Therapeutics Centre (NYRDTC)

  • North East Treatment Advisory Group (NETAG)

The reviews consulted for each individual New Drug Request will be noted in the minutes of the meeting.

As part of the decision making process of the committee, applicants are usually required to attend the meeting to present the case for inclusion of the drug in the formulary.

  • The presentation should last no longer than 10 minutes.
  • Rather than focusing on the pharmacology of the drug, it is expected that thepresentation will identify the following key points:
  • Evidence base for the drug,
  • Define it’s place in therapy
  • Demonstrate what advantages it has over existing treatment options withinthe formulary and whether it would replace any drugs in the formulary
  • An estimate of the number of patients that would receive the drug per year.
  • Suggestions for audit around uptake/appropriate use of drug once approved

All decisions on requests for chemotherapy drugs to be added to theformulary are made by the National Commissioning Board.

Decisions on requests which have a very high financial impact orinvolved specialist commissioning arrangements may be made by theNorth-East Treatment Advisory Group (NETAG).

Adoption of NICE TechnologyAppraised Drugs into the Formulary

Medicines with a positive NICE Technology Appraisal will be automatically added to the local formulary, if clinically appropriate and relevant to the services provided by the organisation. As part of the process of adding these drugs to the formulary, commissioners and clinicians may need to review the relevant local care pathways, to include the medicine in line with NICE recommendations. This process should take place within 3 months of the date of publication of the NICE Technology Appraisal.

If a positive NICE Technology Appraisal states “option for treatment”, the medicine will be added to the local formulary and if necessary its place in the relevant local care pathway(s) be defined. Where the medicine may not be the preferred NICE approved treatment option the medicine will appear in the formulary with the following note “not a preferred option in the current pathway but is available on individual patient basis as per NICE Technology Appraisal”.

Decision Outputs

Applicants for new drug requests will be informed of the decision in writing by the chair within one week of the meeting.

Summaries of decisions regarding new drug requests will be published on the Gateshead NHS Foundation Trust and NHS Gateshead CCG website within 4 weeks of the most recent meeting of the GMMC.

Appeals

Applicants of new drug requests can appeal against decisions of the committee. An intention to appeal against a decision of the committee should be made in writing to the secretary of the GMMC.

Grounds for appeal are as follows:

  • Significant new clinical evidence available to support application not considered as part of original application.
  • Decision appears to be based on inaccurate or incomplete information.
  • GMMC process for the handling of new drug requests has not been followed.

An independent appeals panel consisting of GHFNT Medical Director and an NHS Gateshead CCG Executive representative will assess the validity of the appeal. The appeals panel will inform the appellant, in writing, if the appeal does not satisfy the defined grounds for appeal. The appeals panel will refer appeals that do satisfy the defined grounds for appeal to the next meeting of GMMC for consideration.

Appeals will be heard at an appropriate GMMC meeting where twenty minutes will be allowed to hear the appeal. This would normally comprise a presentation by the appellant followed by questions by the committee. The appellant will be informed of the decision in writing by the chair within one week of the meeting.

Standing Monthly Agenda Items

  • Shared care guidelines for approval
  • NHS Gateshead CCG PGDs for approval
  • Review of latest NICE Guidance
  • Exceptional Case Treatment Requests
  • NETAG update
  • National Commissioning Board New Drugs update
  • GATNET/Gateshead CCG update
  • Drug Safety Alerts & Updates
  • Antimicrobial Prescribing Update
  • NTW Update
  • Formulary Chapter Updates

Standing Quarterly Agenda Items

  • GHFNT drug spend report
  • PCT drug spend report

Standing Annual Agenda Items

  • Horizon Scanning – UKMi Prescribing Outlook (Q3 each year)
  • Review of GMMC Terms of Reference

Review

Terms of reference to be reviewed annually.

Formulary chapters will be updated following each meeting of the GMMC as appropriate to include the latest decisions about new drug requests and the latest MHRA Drug Safety Updates. Each chapter of the formulary will be formally reviewed at least once a year.

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GMMC October 2013