PGD Compliance Checklist — Everything You Need Before You Start
A practical compliance checklist for pharmacies about to start delivering PGD services. Print it, pin it, use it.
Before you deliver your first consultation under PGD, you need to have these elements in place. This checklist covers the legal, clinical, and operational requirements for compliant PGD service delivery in UK community pharmacy.
Legal and Governance: Your PGDs must be authorised by a body legally permitted to do so. Each PGD must be signed by a doctor and a pharmacist. The PGD must be in date — expired PGDs are not valid. Every pharmacist delivering under the PGD must be individually named on the direction. Your pharmacy must have appropriate indemnity insurance covering PGD service delivery.
Training and Competency: Every named pharmacist must have completed accredited training for each PGD they will operate under. Competency assessments must be documented and dated. Records of training completion must be accessible for audit. Ongoing CPD requirements must be met — PGD competence is not a one-off assessment.
Consultation Environment: You need a private consultation room that meets GPhC standards. The room must have appropriate clinical waste disposal (yellow bins for clinical waste, sharps containers for needles). An anaphylaxis kit must be present and in date — this includes adrenaline auto-injectors, and the pharmacist must be trained in their use. For vaccine services, you need a pharmaceutical-grade fridge with continuous temperature monitoring and documented logs.
Documentation and Record-Keeping: Every consultation must be fully documented, including patient identification, clinical assessment, inclusion/exclusion criteria checks, the supply decision, patient counselling provided, and patient consent. Records must be retained for a minimum period as defined in your PGD (typically 8 years for adults, until the patient reaches 25 for children). Records must be stored in compliance with GDPR and accessible for clinical governance review.
Operational Requirements: Standard Operating Procedures (SOPs) for each PGD service must be in place and accessible to all staff. Adverse reaction reporting procedures (Yellow Card scheme) must be understood and accessible. A procedure for managing clinical incidents must be documented. Stock management procedures — including cold chain protocols for vaccines — must be in place.
CQC Considerations: If you are delivering services under PGDs issued by a CQC-registered provider, the provider holds the CQC registration for the clinical service. Your pharmacy should confirm this arrangement is documented. If you are seeking your own CQC registration for independent PGD services, the requirements are more extensive — consult the CQC provider handbook.
Superintendent Oversight: If you operate multiple branches, the superintendent pharmacist must have visibility of which PGDs are active at each site, which pharmacists are trained and named, consultation volumes, and compliance status. A centralised dashboard for this purpose is strongly recommended.
This checklist is not exhaustive — your PGD provider should supply detailed operational guidance. But if you can tick every item above, you're in a strong position to deliver safe, compliant, and profitable PGD services.
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