Procedure checklist · Reg 12

CQC medicines management audit checklist

All CQC-registered providers

Download the PDF

A printable version of this checklist, formatted to work through on paper or take into a team meeting. The disclaimer below applies to the PDF too.

Source anchors

How to use this checklist

Use this checklist to audit whether the service can show safe medicines governance: assessment, prescribing, receipt, storage, administration, controlled drugs, incidents, actions and audit. It can be used monthly, after a medicines incident, before governance review, or before an inspection-readiness review.

Medicines arrangements vary by service model. Check the current legal, professional, pharmacy and product-specific requirements that apply to the service before relying on local defaults.

This is the cross-sector baseline checklist. If you run a care home, use the care home medicines audit checklist. If you run a GP practice or clinic, use the primary care prescribing and medicines audit checklist.

For each row, record:

Every Part met or Not met item should create an action with an owner and due date.

The PDF is designed for printing, or for completing on screen with a PDF viewer's Fill & Sign, Markup or comment tools. Use those tools to tick boxes and type into the lines.

Service details

Field Local entry
Service name
Location
Date completed
Completed by
Registered Manager
Medicines Lead
Controlled-drug lead, where relevant
Period reviewed

1. Roles, scope and competence

Check Evidence to review Status Action owner Due date
Medicines activities carried out by the service are clearly defined. Procedure, service model, statement of purpose.
Medicines Lead and deputy are named. Role list, procedure, rota.
Controlled-drug lead or accountable officer arrangements are clear where relevant. CD procedure, role record.
Staff only carry out medicines tasks they are trained and competent to do. Training matrix, competency assessment.
Prescribers work within legal authority, professional scope and local procedure. Prescriber list, registration check, formulary or protocol.
Pharmacy or specialist advice route is available where needed. Advice record, SLA, contact route.

2. Assessment, prescribing and reconciliation

Check Evidence to review Status Action owner Due date
Medicines support needs are assessed and recorded. Care plan, assessment, consent record.
Prompting, assisting and administering boundaries are clear. Care plan, MAR, staff interview.
Consent, capacity and best-interest decisions are recorded where relevant. Consent note, MCA record.
Prescriptions or medication lists include dose, route, frequency and review point where relevant. Prescribing record, medication list.
Medicines reconciliation happens at transitions and medication changes. Reconciliation record, discharge note, pharmacy query.
High-risk medicines and monitoring needs are identified. Monitoring plan, blood-test record, review note.

3. Ordering, receipt and storage

Check Evidence to review Status Action owner Due date
Medicines are obtained through authorised routes. Supplier record, pharmacy record.
Receipt records show date, quantity and batch or expiry where required. Receipt log, stock record.
Medicines are stored securely and according to product requirements. Physical check, storage procedure.
Fridge or cold-chain medicines have temperature records and escalation evidence. Fridge log, incident record, cold-chain checklist.
Expiry checks are completed and acted on. Expiry audit, disposal record.
Patient-owned medicines are separated, labelled and governed where the service handles them. Storage check, care record.

4. Administration and recording

Check Evidence to review Status Action owner Due date
Administration records are completed at the time of administration. MAR sample, audit record.
Omissions, refusals and unavailable medicines are recorded with reason and action. MAR sample, incident or follow-up note.
PRN medicines have current protocols. PRN protocol, MAR, care plan.
Covert administration decisions meet capacity, best-interest and professional advice requirements. MCA record, pharmacy or prescriber advice.
Injectable medicines, sharps, medical gases or delegated tasks have specific competence evidence where relevant. Competency record, procedure, disposal record.
Self-administration is risk assessed where used. Self-administration assessment, storage record.

5. Controlled drugs, incidents and alerts

Check Evidence to review Status Action owner Due date
Controlled drugs are stored, recorded and reconciled according to local legal requirements. CD register, cabinet check, balance check.
CD discrepancies are escalated and investigated the same day. Discrepancy record, incident, escalation note.
Medicines incidents and near misses are reported and reviewed. Incident sample, medicines theme report.
Harm, duty of candour, safeguarding and statutory notification decisions are considered. Linked records, decision notes.
Medicine alerts and recalls are logged, assessed and closed with evidence. Alert log, action evidence.
Repeated omissions, refusals or errors are reviewed as governance themes. Governance minutes, action log.

6. Audit and governance

Check Evidence to review Status Action owner Due date
Medicines audits run at a stated cadence. Audit schedule, completed audits.
Audit covers records, storage, expiry, incidents and competence. Audit tool, sample results.
Controlled-drug checks are included where relevant. CD audit, balance check.
Actions from medicines audits have owners, due dates and completion evidence. Improvement actions, evidence.
Medicines risks are added to the risk register where needed. Risk register, audit or incident link.
Registered Manager reviews medicines themes and overdue actions. Governance minutes, dashboard.

7. Summary judgement

Question Answer
Which medicines process carries the highest current risk?
Which medicines record has the weakest evidence trail?
Which omission, refusal or error theme repeated in the last 12 months?
Which action or audit finding is overdue?
What would a CQC inspector see if they asked for medicines evidence today?

8. Action log

Action Source check Owner Due date Completion evidence

9. Completion

Sign-off Name Date
Completed by
Reviewed by Registered Manager

This checklist is a working tool. It does not replace live regulator guidance, professional advice, pharmacy advice, product-specific requirements, controlled-drug legal advice or clinical judgement.

Related reading

This checklist is a starting point and a guide to what inspectors look for. It is not a complete or deployable procedure, and it is not legal advice. Working through it does not guarantee a rating or compliance. Check all regulatory references and timescales against current primary sources and adapt it to your own service.

Want help adapting this to your service?

A Verivius consultant (an ex-CQC inspector) can work through this with you against the live regulation and your service shape. The work fits inside a Mock Inspection engagement or a shorter consulting brief. A 20-minute conversation is the fastest way to find out whether the fit is right.

Get started free

Free to start, no card. A 14-day trial when you subscribe.