Medicines governance procedures

NHS Borders

• Colleagues in NHS Borders looking to prescribe a non-formulary product (including off-label/unlicensed use) must complete a Non-Formulary Medicine/Wound Product Request Form. Further details are provided on the form.

NHS Fife

• Colleagues in NHS Fife orders looking to prescribe a non-formulary product should contact the Fife Medicines Management Team for guidance.

NHS Lothian

Prescribing Non-Formulary Medicines in NHS Lothian

• The key information documents are available on the NHS Lothian Policy Online website under the 'Safe use of Medicines Policy' page.
• If the request is to initiate or continue a non-formulary medicine in primary care, contact your primary care pharmacist or the Primary Care Pharmacy Team for guidance.
• For any additional queries please contact the Medicines Governance and Guidance Team.

NHS Lothian PTR Panel

There is a main Patient Treatment Request (PTR) panel and a separate Cancer Medicines Management Committee (MMC) (for adult patients). All Peer Approved Clinical System Tier 1 (PACS1) applications and Peer Approved Clinical System Tier 2 (PACS2) applications should be submitted to the main panel. Other PTR applications for cancer medicines in adult patients go to the cancer MMC, PTR requests from other specialities should be submitted to the main PTR panel.

Please send completed PACS1, PACS2 or non-cancer PTR application forms and supporting material for review by the NHS Lothian PTR panel to the PTR Administrator.

The PTR panel is also responsible for the following procedures:

• PACS1 is for ultra orphan medicines not recommended for use by SMC prior to June 2018. Paperwork is available from the PTR Administrator. Assessment by SMC under the ultra-orphan process prior to June 2018 is noted within the detailed advice document published by the SMC. The ultra-orphan pathway from June 2018 has a revised definition for ultra-orphan medicines. For more information see the guidance on the SMC website.
• Medicines assessed in the new ultra-orphan pathway are issued an Ultra Orphan Medicine Assessment Report (UMAR). For medicines within the ultra-orphan pathway undergoing assessment/awaiting Scottish Government approval contact the Medicines Governance and Guidance Team for further advice.
• ‘National guidance on requests for licensed medicines that are not routinely available, and are not accessible through Peer Approved Clinical System (PACS) processes’ is currently in development. In the interim please use the IPTR application form for SMC non submissions, and contact the Medicines Governance and Guidance Team for further advice.
• A procedure for surgical procedures not recommended by NHS Policy is in development. In the interim applications should be made on the old IPTR application form.