NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines

Non-Formulary Information and Processes Including Peer Approved Clinical System and Individual Patient Treatment Requests (IPTRs)

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 (also available as a separate PDF) 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 Formulary and Handbook Team (see contact us)

 

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.

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: 

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

What 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.

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