Background

The Pharmacy Contraception Service is being extended to allow Pharmacists and Pharmacy Technicians to deliver two Oral Emergency Contraception medicines via two new Patient Group Directions (PGDs).

The Summary of Change provides links to the draft Patient Group Directions (PGDs), draft uplifted NHS Pharmacy Contraception Service Specification, latest NHSBSA Contraception API client specification and NHS Pharmacy Contraception Service Technical Guidelines, which contains information about the enhanced data flows to the NHSBSA and the Patient’s registered GP Practice.

Please note the following changes:

• The Levonorgestrel National PGD contains a minor formatting change in the ‘Records’ section, and is available from NHS Pharmacy Contraception Service June 2025

• The NHS Pharmacy Contraception Service Technical Guidelines includes a correction to dose-duration (9M added) to ensure consistency with the NHSBSA Contraception API client specification.

Suppliers should take note of the following related Roadmap Items:

• RM274 Update to Pharmacy First Clinical Pathways

• RM276 Update Pharmacy Contraception Service to include a new medication for Oral Contraception

Outline Plan

Supplier Solutions must be fully compliant with the changes outlined in the Summary of Change by the Effective Date.

Summary of Change

Full Specification

The Consultation Management - Community Pharmacy Capability and NHSBSA Claims & Reporting Standard will be uplifted on the Effective Date with the changes outlined in the Summary of Change above.

Assurance Approach

To be fully assured on the change, Suppliers are required to complete the following Assurance steps:

1. Supplier Clinical Safety Officer (CSO) responsibilities

   1. Suppliers' CSO must attend a meeting with NHSE to confirm understanding of their clinical safety responsibilities.

   2. Suppliers' CSO is required to participate in all Assurance calls.

2. Suppliers internal testing requirements

   1. Suppliers must complete Product testing, Regression testing and an internal Clinical Review.

   2. Supplier test scenarios are to cover all elements of the Supplier Solution that require changes. Supplier test reports to be shared with NHSE once Supplier testing is successfully concluded.

   3. Suppliers must provide written confirmation from their CSO stating that all internal tests have been completed. NHSE will accept email as written confirmation.

3. Solution Assurance

   1. Suppliers will be asked to demonstrate their mitigations against the pre-identified risks through completion of the NHSE Solution Assurance Risk Log submission.

4. End to End Witness Test

   1. NHSE will schedule an End to End Witness Test with the Supplier, NHSE Clinical Team and Policy colleagues.

   2. The testing will include pre-defined clinical scenarios to cover uplifts to the Pharmacy Contraception Service inclusive of the UI and data flows to the NHSBSA and the Electronic Patient Record (EPR) using GP Connect Update Record. These tests will be carried out in the Integration Test (INT) environment.

   3. Suppliers must demonstrate their Solution in the INT environment for various test scenarios as outlined in the Test Packs using a pass/fail approach. Test Packs will be provided by NHSE once development is complete and assurance dates are arranged. NHSE’s Pharmacy Contraception Service - Test Scenarios are provided for reference.

   4. Suppliers must be prepared to test additional items that may arise during the session that may not necessarily be called out in the Test Packs. e.g. functionality that is likely to impact clinical safety.

   5. All relevant INT environments, such as NHSBSA, will be available for the testing. Suppliers and the NHSBSA will ensure that correct IP address ranges are allowlisted in their INT environment so that test messages can be sent/received successfully during the test.

   6. Following the End to End Witness Test, the NHSBSA will provide evidence (screen shots or report) to NHSE to demonstrate that payment data reconciles between the Supplier Solution (Sender) and the BSA API (Receiver)

5. Clinical Assurance

   1. Suppliers must submit an uplifted Clinical Safety Case Report (CSCR) and Hazard Log which has been signed off by the Supplier’s Clinical Safety Officer (CSO) in accordance with the NHSE Clinical Safety Group (CSG) requirements and in compliance to the Clinical Safety Standard (DCB 0129).

   2. Clinical Safety Group (CSG) will review and approve the CSCR then uplift the Clinical Authority to Release (CATR), to include Oral Emergency Contraception (Oral EC) for GP Connect Update Record.

6. Smoke Testing

   1. The Supplier must complete Smoke Testing in the Live environment, in collaboration with NHSE.

Note: Suppliers can contact their Supplier Manager for more information on the Assurance Approach outlined above.