NHSAAA Adult Joint Formulary

NHS Ayrshire & Arran aim to promote high-quality, cost-effective prescribing in all areas of care. This Therapeutics Handbook is one such tool for prescribers to help ensure that they are consistently giving patients evidence-based treatment.

Good prescribing dictates that the choice of therapy should be made on the basis of sound clinical evidence of efficacy, safety and also takes into consideration patient acceptability and cost effectiveness. The NHS Ayrshire & Arran Adult Joint Formulary takes the above into account when considering a medicine for inclusion and therefore prescribing from the Formulary is consistent with good clinical practice.

All licensed medicines referred to in this handbook are included in the NHSAAA Adult Joint Formulary.

Non-Formulary prescribing and processes

The need for prescribing of medicines from outwith the Formulary (non-Formulary prescribing) is recognised, but it is expected that:

Formal treatment guidelines / protocols will only include Formulary medicines.
Non-Formulary status will apply to new medicines until accepted for use by the Scottish Medicines Consortium (SMC) and the Area Drug and Therapeutics Committee (ADTC). Further information regarding the SMC, including all previous decisions, can be found on their website: www.scottishmedicines.org.uk.
Non-Formulary prescribing may be necessary and approved for individual patients in accordance with local processes including the Peer Approved Clinical System Tier 2 (PACS 2), Individual Patient Treatment Request (IPTR) and case by case processes.
An overview of the main routes of access to medicines which are not recommended for use by the SMC or awaiting evaluation is available as a useful flowchart (link only active if accessing via NHS network) to help ascertain which process to follow. Further information, including the flowchart, is available on AthenA / Code of Practice for Medicines Governance.

Peer Approved Clinical System Tier 1 (PACS UO)

This is currently the process used by clinicians to access medicines for ultra-orphan conditions which have been evaluated under the ultra-orphan framework before April 2019 and are subsequently not recommended for use in NHSScotland or are validated as being ultra-orphan in Scotland, but have not been assessed by SMC.

Peer Approved Clinical System Tier 2 (PACS 2)

PACS 2 is intended to be used for requests for licensed medicines and indications where:

The SMC has evaluated the medicine and indication and issued 'Not Recommended' advice, or;
The request relates to the use of a medicine outwith the SMC restrictions, or;
The medicine and indication have been submitted to the SMC, but the SMC are yet to issue advice.

Individual Patient Treatment Requests (IPTR)

The IPTR process will likely be replaced in the near future, but currently it is still a valid route of requesting access to medicines in the following specific circumstances:

Where the SMC have issued 'Not Recommended' advice because the manufacturing company has not made a submission to SMC for this medicine or indication, or;
Where a company have yet to make a submission to SMC for this medicine and indication
Where the intended use of the medicine is outwith the SMC restrictions where these are based solely on the company requesting a selective positioning or sub-population.

Case by Case Requests

Where there are funding or service implications, the medicine will be available on a case by case basis until a local protocol has been agreed.

Where to find Formulary information

The NHSAAA Joint Formulary can be found on the AthenA homepage / Joint Formulary (link only active if accessing via NHS network). Alternatively, the Medicines Information Team (see Appendix 6 for contact details) are happy to answer any specific queries where the information is not readily available.

Guideline reviewed	September 2024
Page updated	October 2024