As of 7 January 2026, the Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 has officially introduced new flexibilities for community pharmacies across the UK.
The most significant change allows for the "hand-out" of prescriptions that have already been clinically and accuracy-checked while the Responsible Pharmacist (RP) is temporarily absent. However, this new flexibility comes with strict requirements for clinical governance and staff competency.
Why You Need a Dedicated SOP Now
Under the new regulations, the Responsible Pharmacist can be absent for up to two hours. To maintain patient safety during this window, pharmacies must have a robust Standard Operating Procedure (SOP) that defines exactly who can hand out medication and how clinical queries are managed.
Without a clear SOP, your team risks:
Legal Non-Compliance: Handing out medications without explicit RP authorisation.
Safety Risks: Missing a vital clinical intervention for a "High-Risk" medication.
Regulatory Gaps: Failing to document staff training and competency assessments.
Key Features of the New Protocol
The provided SOP template is designed to bridge the gap between legislative change and daily practice. It focuses on three core pillars:
Explicit Authorisation The RP must assess the competency of the staff member and provide either verbal or written authorisation before leaving the premises. This isn't a blanket permission; it is specific to the individuals recorded in the Staff Authorisation Log.
The Clinical Gatekeeper Role Even in the pharmacist's absence, clinical safety remains the priority. The SOP mandates a "Clinical Intervention Screen" for every hand-out:
- Identify New Meds: Staff must ask if the medication is new to the patient.
- Filter Queries: If a patient has a clinical question, the medication must not be handed out.
- Signpost Care: Staff must offer a return time or a phone consultation for clinical concerns.
- Strict "Red Lines" There are specific tasks that remain strictly prohibited during a pharmacist's absence to ensure public safety:
- Controlled Drugs (CDs): Schedule 2 and 3 CDs must not be handed out.
- New Dispensing: No labelling or assembly can occur while the pharmacist is away.
- P-Medicine Sales: Supervision rules for P-medicines remain distinct from the "bagged and checked" hand-out process.
Preparing Your Team
Preparation is more than just reading a document. The included Appendix B provides a practical Competency Assessment using roleplay, case studies, and practical demonstrations to ensure your staff are ready for real-world scenarios.
Download PDF: SOP Template - Authorisation of Hand-out During Pharmacist Absence