Non-Formulary Information and Processes Including Peer Approved Clinical System (PACSUO, PACS2), Individual Patient Treatment Requests (IPTRs) and Unlicensed Medicines requests (ULM1)
This section contains the supporting documentation for the non-Formulary processes within NHSGGC (see Medicines Policies for details) and a list of cumulative non-Formulary negative decisions between 1992 and the present.
Which Process and Form should be used?
There is often confusion as to when an IPTR is required as opposed to different processes for off-label or unlicensed medicines or requests for medicines accepted by SMC. The following flowchart should be used to check that the correct documentation is selected before being completed (when used along with the relevant policies). If still unsure, then check with your clinical pharmacist, local pharmacy department, Medicines Information or the Medicines Policy & Guidance Team (see contact us)
Note: The process flowchart below is in the process of being updated to account for the introduction of the new Ultra-Orphan Medicines Pathway which is currently being implemented. Seek guidance from the Medicines Policy and Guidance Team if there is any uncertainty.
Click on the flowchart above to open the full size flowchart as a printable PDF
Ultra Orphan Pathway (UO Pathway)
The Scottish Government produced guidance on the implementation of the Ultra-Orphan Pathway in April 2019. For most medicines for ultra-orphan conditions, this pathway will replace the need to use the PACS UO process (detailed below). Local processes are currently being updated to reflect the new pathway, and will be made available from this page, and the Medicines Policies page in due course.
In the meantime, the Scottish Government guidance on the Ultra-Oprhan Pathway can be accessed by clicking here.
Peer Approved Clinical System Tier 1 (PACS UO)
PACS UO is currently the process used by clinicians to access ultra-orphan medicines which have been evaluated by the SMC under the ultra-orphan framework and are subsequently not recommended for use in NHSScotland. The full policy can be accessed via the Medicines Policy page of this website.
- PACS list - Oncology (guidance on which medicines require a PACS form completion)
- PACS eForm
- PACS Reporting Form
Peer Approved Clinical System Tier Two (PACS 2)
PACS 2 is intended to be used for requests for licensed medicines and indications where:
- The Scottish Medicines Consortium (SMC) has evaluated and issued 'Not Recommended' advice for the medicine and indication or;
- The request relates to a use of the medicine outwith the SMC restrictions or;
- The medicine and indication have been submitted to the SMC, but the SMC are yet to issue advice
The NHSGG&C PACS 2 Policy can be accessed via the Medicines Policy page of this website
- FORM PACS2: The request form that should be completed by clinicians wishing to gain access to a medicine for an individual patient that meets the above applicability criteria.
- PACS 2 Decision Making Framework: A tool to assist panels in considering requests made by the PACS 2 process
- PACS 2 Patient Information Leaflet: A leaflet that should be issued to patients by clinicians requesting a medicines via PACS 2 on their behalf
Individual Patient Treatment Requests (IPTRs)
Though the PACS 2 process replaces most of the situation where an IPTR would previously used, IPTRs are still required for medicines which:
- Where the SMC have issued 'Not Recommended' advice because the manufacturing company has not made a submission to SMC for this medicine and indication or;
- Where the company have yet to make a submission to SMC for this medicine and indication
The following should be referred to and used in accordance with the Management of IPTRs Policy available on Medicines Policy page of this website.
- Form IPTR3 (The main IPTR documentation used in NHS Greater Glasgow and Clyde)
- Form IPTR APPEAL (To be used by clinicians to appeal an IPTR decision)
Unlicensed medicine and Off-label documentation (ULM):
The following should be referred to and used in accordance with the Unlicensed Medicines Policy available on the Medicines Policies page
Requests for licensed oncology medicines when they are either non-Formulary or being used outside of the regional protocols:
- Form SONFR (The Specialist Oncology Non-Formulary Request documentation)
Other supporting documentation for the acute non-Formulary processes can be found in the Medicines Policies page
Requests to initiate Lidocaine 5% Plasters
Which medicines have been turned down for inclusion in the GGC Formulary?
The following links are a list of all the medicines/indications/formulations that have been rejected for inclusion in the GGC Formulary. Since around 2002, most of these have been because the medicine was not recommended for use in NHS Scotland following evaluation by the SMC or NHS Health Improvement Scotland.
- Cumulative List of Non-Formulary Decisions (April 2012 - December 2017)
- Cumulative List of Non-Formulary Decisions (1992 - March 2012)
From January 2016 onwards a cumulative list of local decisions relating to SMC advice and, where applicable NICE Multiple Technology Appraisals can also be found here