Requesting changes to the formulary

The East Region Formulary is a dynamic resource which aims to promote safe, effective and economic prescribing in both hospital and general practice. The formulary content is reviewed regularly by working groups of health professionals from across NHS Borders, NHS Fife and NHS Lothian. Working groups are facilitated by a Formulary Pharmacist. Suggestions for the addition, deletion or substitution of drugs, or updates to content are welcomed by the East Region Formulary Committee.

Getting a ‘new’ drug on to the formulary

• Where the term ‘new’ drug is used, this means any new drug that is:

  • not already on the formulary, or
  • a new indication for a drug that is already on the formulary, or
  • the use of a drug that is already on the formulary for a patient group that is not yet included.

• ‘New’ drugs must be recommended by the Scottish Medicines Consortium (SMC). Formulary Application Form (FAF1) must be completed for drugs reviewed and recommended by SMC. Not all new drugs approved by the SMC will be appropriate for inclusion in the formulary. The formulary will normally only include those suitable for prescribing first or second choice.

• For local decisions, first check both the Medicines A-Z and the Formulary Decisions screens on the East Region Formulary website to check the current formulary status of the 'new' drug.

• If the drug is not on the formulary for the indication or patient group in question, refer to the Formulary application process page for more information. That page includes process flows and application forms to complete when proposing the addition of a 'new' drug for use in a patient group. The correct form to complete will relate to whether the drug falls within the remit of SMC. For information on medicines outwith SMC remit please see SMC guidance. If the medicine is outwith SMC remit and is being used within the product licence, the correct form will be a FAF2.

• When the proposal is to add a new strength; new formulation; or new presentation of an existing proprietary medicine already on the formulary (including biosimilars - see additional information in medicines outwith SMC remit and SMC statement regarding biosimilar medicines), with no associated change to the:

  • patient group for use, or
  • licensed indication, or
  • route of administration, and
  • the new product costs the same per patient or less

the correct form is a Formulary Amendment Request Form.

• See the ERF statement for more information on branded generics.

• A formulary amendment request form may also be appropriate for an existing proprietary medicine already on the formulary (including biosimilars) for:

  • use in a new patient group;
  • deletions;
  • changes to the order of choices;
  • changes to prescribing notes.

Note that a formulary amendment request form should not be used if the proposed use is:

• • a new off-label use;
  • within SMC remit and awaiting or not yet submitted to SMC for approval;
  • not recommended by SMC;
  • outwith SMC restriction.

If any of the above refer to Medicines governance procedures for more information.

• The Formulary Amendment Request Form​ (including the Declaration of Interests) should be completed by a pharmacist, GP or consultant. The request should have the support of both a clinician and a pharmacist. The clinician may be a non-medical specialist prescriber, where the clinician is a pharmacist, a second pharmacist signature is required.

• Completed forms should be returned to the Formulary Team. All requests for medicines to be added to the formulary require supporting information from all three health boards. Ideally the information will show that all wish the medicine to be included, if boards differ then the reasons for differing positions will be considered by formulary committee in making a decision.

• You may be contacted again if further information is required regarding this request.

• All requests will be reviewed by the appropriate working group and/or the Formulary Committee, and the relevant pharmacist and clinician informed of the decision.