NHS Lanarkshire Guidance on the Development, Approval, Review, and Monitoring of Medicine and Non-Medicine Related Guidelines aims to ensure that NHSL clinical guidelines are developed and agreed, ensuring all key staff are involved and informed, and that the guidelines reflect best practice. Furthermore, the process aims to ensure that clinical guidelines are kept under regular review and are up to date.

NHSL Guidelines app/website (“App”) is available to all staff and independent contractors in NHSL. All approved guidelines should only be published to the App.

This will support:

• Governance.
• Review of clinical guidelines.
• Reduce potential duplication.
• Lessen the use of out-of-date guidelines.

Developed or updated guidelines should be ratified and then submitted to Clinical Guidelines Team (CGT) for publication to the App. 

NHS Lanarkshire clinical guidelines may be developed at one of the following levels (with ratification):

• NHS Lanarkshire wide.
• An individual operational entity, or groups of operational entities.
• An individual department/service/specialty/directorate (only where exclusively relevant to that area).

Clinical guidelines should only be developed where there is a need for a clinical guideline and duplication of guidelines should be avoided if there is NHSL wide guideline for the same condition already available:

• The guideline has clearly defined authorship and ownership.
• The guideline recommendations are specific and unambiguous.
• The guideline contains the last and next review date.
• The title of the guideline accurately reflects the content and the scope of the guideline.
• The target users of the guideline are clearly defined.
• The population that the guideline applies to is specifically described.
• The development of the guideline is informed by evidence and individuals from all relevant professional groups.
• The potential cost implication of applying the recommendations has been considered.
• The implementation and evaluation plans have been considered.
• The supporting evidence has been referenced accurately.
• The copyright permissions for all text and images used should be confirmed.

A submission form should be completed for all new and updated clinical guidelines to ensure reviewer and ratifier details remain current, and the following actions should be taken:

1. The lead author completes the submission form to the best of their ability
2. Medicine related guidelines should be forwarded to ADTC for approval and ratification
3. Non-medicine related guidelines should be forwarded to the HoD. The HoD provides feedback and approves or refers back to the Lead Author for additional work. These guidelines then need to be sent to Guidelines Editorial Group (GEG) for final ratification
4. All ratified guideline and the completed submission form should be submitted to Clinical Guidelines Team (CGT) for publication to the App.

Guidelines involving medicines and meeting one or more of the following criteria:

• The clinical guideline involves use of medicine(s) and has clinical implications for multiple directorates within Acute and/or is expected to be used across Acute and Primary Care.
• There are significant new cost implications beyond a single Acute Service and for Primary Care.
• There are significant new service implications beyond a single Acute Service and for Primary Care.
• The clinical guideline has been produced by a Managed Clinical Network.
• The clinical guideline includes non-formulary medicines.
• Clinical guidelines developed for new medicines specifically at the request of ADTC or its subcommittee.

The Guidance on the Production of Guidelines and Protocols Involving Medicines must be followed, and these guidelines referred to the ADTC and submitted together with the submission form. 

If you are uncertain whether the guideline requires the ADTC approval, seek advice from the Chair of ADTC.

Clinical Guidelines for Cancer Medicines 

The West of Scotland Cancer Network (WoSCAN) Regional Cancer Advisory Group (RCAG) develops and approves a large number of clinical guidelines for the treatment of cancer. These for the use of chemotherapy and other adjunctive therapy in the management of cancer are generally developed and approved for use within the WoS by the Regional Cancer Advisory Group/Prescribing Advisory Subgroup (RCAG-PAG). These guidelines are ratified by the ADTC.

Clinical Guidelines Involving Antimicrobial Medicines

Antimicrobial guidelines which meet specific criteria are reviewed by the Antimicrobial Management Team (AMT).

Principles detailed for developing guidelines should be adhered to and guideline subsequently approved by HoD.These guidelines should then be forwarded to the Guidelines Editorial Group for ratification.

A review process will be initiated for the published guideline. The Lead Author of the guideline is responsible for its review and will be notified by the CGT prompting a review to be undertaken, at three, one month and when expired. It is the Lead Authors’ responsibility to advise whether the guideline is valid, has been superseded or is obsolete.

• If the guideline remains valid the Lead Author should refresh the document with updated review dates, and completion of a new submission form is required.
• If the guideline is no longer valid or required, it will be removed from the App.

Should the decision about the guideline not be concluded the CGT will contact the appropriate HoD.

Any guideline which is out of date (expired guideline) will be marked as such on the App and reported to the Clinical Guidelines Governance Group (CGGG) for further actions, including removal.

NHSL Medical Director & Clinical Lead for Guidelines

• Overall responsibility for the NHS Lanarkshire Guidance on the Development, Approval, Review, and Monitoring of Medicine and Non-Medicine Related Guidelines process. 
• Ensure that the requirements of the NHS Lanarkshire Guidance on the Development, Approval, Review, and Monitoring of Medicine and Non-Medicine Related Guidelines process are followed.

Lead Authors and Reviewers

• Adhering to the principles outlined in NHS Lanarkshire Guidance on the Development, Approval, Review, and Monitoring of Medicine and Non-Medicine Related Guidelines. 
• Ensure implementation and communication processes are in place for their approved clinical guidelines. 
• Identifying training needs. 
• Ensure developed or updated guidelines are ratified and then submitted to Clinical Guidelines Team (CGT) for publication to the App. 
• Action removal of duplicate or conflicting guidelines stored in any electronic system other than the NHSL Guidelines (e.g. FirstPort).

Line Managers

• Ensure that the requirements of the NHS Lanarkshire Guidance on the Development, Approval, Review, and Monitoring of Medicine and Non-Medicine Related Guidelines are followed.
• Ensure systems are in place to review and implement relevant approved clinical guidelines in their areas. 
• Ensure clinical guidelines are accessible for all their staff. 
• Ensure staff have read and understood the clinical guidelines specific to their area. 
• Ensure systems exist to identify staff training needs on the implementation of new clinical guidelines.

All NHS Lanarkshire Staff

• Making themselves aware of NHS Lanarkshire Guidance on the Development, Approval, Review, and Monitoring of Medicine and Non-Medicine Related Guidelines. 
• Knowing how to access the NHSL Guidelines app/website (“App”). 
• Refer to clinical guidelines approved by NHS Lanarkshire as first port of call.

Process for Development, Approval, Review, & Monitoring of Medicine and Non-Medicine Related Guidelines - Pathway

Definitions

Clinical Guidelines

Clinical guidelines are often used to underpin a policy. They are a set of standards or rules which assist in the decision on how to apply the policy or manage specific conditions.

Clinical guidelines are evidence-based statement (or series of statements) used to assist clinicians in the decision-making process about appropriate treatment and care in specific circumstances. Clinical guidelines are not intended to replace clinical freedom; however, they should normally be followed unless there is a good reason not to do so. Clinical guidelines often include algorithm/flowcharts – if A happens do B; if X happens do Y and Z.

Key Features:

• Clinical guidelines are not the ultimate decision makers regarding a particular clinical procedure or treatment plan. The ultimate decision must be made by the practitioner in the light of each individual patient’s condition, circumstances, and the diagnostic and treatment options available.
• Clinical guidelines provide recommendations for effective practice in the management of clinical conditions where variations in practice are known to occur and where effective care may not be delivered uniformly throughout Scotland.
• Clinical guidelines can be used to develop standards to assess the clinical practice of health professionals.
• Clinical guidelines can be used in the education and training of health professionals.
• Clinical guidelines can help patients to make informed decisions and improve communication between the patient and health professional.
• Clinical guidelines are often interchangeably with protocols. Some clinicians take the view that protocols must be followed, whereas clinical guidelines are only there to advise and inform decision-making. However, it is doubtful whether in law this distinction is helpful or meaningful. Whether you call something a guideline or a protocol, if agreement has been reached that this document constitutes best practice, you should be able to justify any occasion where it is not followed.
• Clinical guidelines direct clinicians along preferred treatment pathways by outlining detailed management plans for discrete clinical conditions judged amenable to stepwise decision-making processes (e.g. flowcharts, algorithms).
• Clinical guidelines can be detailed descriptions of the steps taken to deliver care or treatment to a patient and are sometimes called the ‘integrated care pathway’.
• MEDLINE definition: ‘Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy’.

Protocols

Protocols are a set of measurable, objective standards which determine a course of action.

Protocols are often interchangeably with clinical guidelines. Some clinicians take the view that protocols must be followed, whereas clinical guidelines are only there to advise and inform decision-making. However, it is doubtful whether in law this distinction is helpful or meaningful. Whether you call something a guideline or a protocol, if agreement has been reached that this document constitutes best practice, you should be able to justify any occasion where it is not followed.

Key Features:

• A more specific document.
• Narrow application.
• Stated in detail.
• How, When and Who.
• Describes process.

Policy

A policy is a specific statement of principles / guiding actions that provide a basis for consistent decision-making and resource allocation. A course of action established as a guide towards accepted objectives. Guidance on either finding or writing a policy is available on theFirstPort: Policies pages (NHSL Staff Access Only).

Procedure

A procedure is a series of steps followed in regular order taken to implement a policy. Procedures can be mapped using a flowchart.

Relevant Governance Group

ADTC – Area Drugs and Therapeutics Committee

CGGG – Clinical Guidelines Governance Group

CGT – Clinical Guidelines Team

GEG – Guidelines Editorial Group