Formulary application process

View guidance and access forms used to request approval of medicines for prescribing

The East Region Formulary is a dynamic resource which aims to promote safe, effective and economic prescribing in both hospital and general practice. Suggestions for the addition, deletion or substitution of drugs are welcomed by the East Region Formulary Committee (ERFC).

The East Region Formulary (ERF) is a joint formulary developed between NHS Borders, NHS Fife and NHS Lothian. Therefore, all applications to the ERFC must come with information from all three Health Boards. An overview of the application process can be found in these accompanying documents:

Application forms

Form	Notes
Formulary Application Form 1 (FAF1)	This form is for medicines that have been considered and approved by the Scottish Medicines Consortium (SMC). The form is completed to request the medicine be approved for use. It can also be used to indicate that the medicine should not be routinely used, as there are suitable medicines available that are preferred for use by clinicians.
Formulary Application Form 2 (FAF2)	This form is for medicines that have not been assessed by the SMC, as they have been available for that indication prior to SMC being formed, or where SMC have indicated that it is outwith their remit.
Formulary Application Form 3 (FAF3)	This form is for medicines that are being used in an 'off-label' indication or for unlicensed medicines. FAF3 forms should be submitted to East Region Working Group (ERWG) for support prior to being submitted to the ERFC.
Formulary Application Form 4 (FAF4)	This form is for medicines that have been considered and not recommended by the Scottish Medicines Consortium (SMC) and advice is > 10 years old. The form is for medicines where the place of the medicine in a therapeutic pathway is considered to have changed, based on significant new evidence, safety, or cost-effectiveness. Any new advice from SMC for the same medicine and indication will supersede local decisions. Contact us for a copy of the form.
Formulary Amendment Form	This form is used to request an amendment to the Formulary. It should be completed by a pharmacist, GP or consultant to request addition of a drug, other than a ‘new’ drug, as a minor amendment to the Formulary. The request should have the support of both a clinician and a pharmacist. The form should be returned to the Formulary Pharmacist who may ask for a more detailed Formulary Application Form (FAF2) to be completed if appropriate. All requests will be reviewed by the ERWG and/or the ERFC, and the relevant pharmacist and clinician informed of the decision. Applicants may be contacted again if further information is required regarding the requested amendment.

Please send completed forms to prescribing@nhslothian.scot.nhs.uk. All requests require sign off by a pharmacist and clinician (two different individuals) and support from the three board clinical teams. Formulary applications FAF1,2,3,4 require support from the clinical directors or equivalent medical managers in the three boards. For help with contact details in each Board, please contact the Board formulary teams: for NHS Borders, email BOR.Prescribing@borders.scot.nhs.uk, for NHS Fife, email Fife.fifemedicinesmanagement@nhs.scot, and for NHS Lothian, email prescribing@nhslothian.scot.nhs.uk.

Applicants may be contacted again if further information is required regarding the requested amendment, or in some instances to be advised to use a different application form if deemed appropriate. Applications will be reviewed by the East Region Working Group (ERWG) and/or the ERFC, and the pharmacist and clinician on the application informed of the decision.

Process for SMC abbreviated advice

A streamlined process can be followed for SMC abbreviated advice for product updates and medicines where alternatives within the same therapeutic class are already available on the formulary for the same indication. Refer to the abbreviated submission process flow chart for details.

Process for paediatric licence extensions

Since January 2020 SMC no longer issue abbreviated advice for paediatric licence extensions (PLEs). Boards are updated by SMC when PLEs are granted along with details of SMC advice for the corresponding indication in adults. Where the medicine is on the formulary for the corresponding indication in adults, formulary inclusion on the child ERF may be considered via a streamlined process. Formulary inclusion for PLEs (already included in the adult ERF) are under consideration in the ongoing work with local experts to develop the ERF paediatric chapters. Contact us for more information on how to request formulary inclusion for PLEs that have not yet been considered in this work.

Procedures for non-approved medicines

Guidance on the procedures for prescribing non-approved medicines can be found on the Medicines governance procedures page.