Source anchors
How to use this checklist
This is the primary care (GP practices and clinics) version of the medicines checklist. It assumes the service prescribes, may supply or administer medicines under Patient Group Directions, and holds some stock including controlled drugs. For a care home that administers prescribed medicines, use the care home version.
Use it to audit whether the service can show safe medicines management: prescribing governance, Patient Group Directions, high-risk and monitored medicines, controlled drugs, antimicrobial stewardship, storage, and safety and audit. Use it on a stated cadence, after a medicines incident, before a governance review, or before an inspection-readiness review.
Medicines arrangements vary. Check the current legal, professional, pharmacy and product-specific requirements that apply to the service before relying on local defaults.
For each row, record:
- Met: evidence is current and complete.
- Part met: evidence exists but has a gap or needs follow-up.
- Not met: evidence is absent or the control is not working.
- Not applicable: the service does not carry out this activity.
Every Part met or Not met item should create an action with an owner and due date.
Service details
| Field |
Local entry |
| Service name |
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| Location |
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| Date completed |
|
| Completed by |
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| Medicines or prescribing lead |
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| Controlled-drug lead, where relevant |
|
| Period reviewed |
|
1. Roles, scope and competence
| Check |
Evidence to review |
Status |
Action owner |
Due date |
| A medicines or prescribing lead is named, and a controlled-drug lead where relevant. |
Role list, procedure. |
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| Prescribers work within their legal authority, professional scope, competence and the practice formulary. |
Prescriber list, registration check, scope record. |
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| Staff only carry out medicines tasks they are trained and assessed competent to do. |
Training matrix, competency assessment. |
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| The service knows its controlled-drug oversight route: it is not usually a designated body that appoints its own Controlled Drugs Accountable Officer, so it knows the NHS England Accountable Officer and Local Intelligence Network for its area and reports controlled-drug concerns through it. |
Procedure, local CD contacts, reporting route. |
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| Pharmacist or specialist medicines advice is available (for example a practice or PCN pharmacist). |
Advice record, role record. |
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2. Prescribing governance
| Check |
Evidence to review |
Status |
Action owner |
Due date |
| Prescribing follows local and NICE guidance and the practice formulary, with generic prescribing where appropriate. |
Formulary, prescribing guidance, audit. |
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| Repeat prescribing has a defined process: authorisation, quantity and interval, and a clear review point. |
Repeat-prescribing procedure, sample records. |
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| Repeat medicines are reviewed and reauthorised at a stated interval rather than issued indefinitely. |
Medication-review record, reauthorisation log. |
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| Prescription security and electronic prescribing are governed, and lost or stolen prescription forms or tokens are reported. |
Security procedure, incident log. |
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| Medicines are reconciled at transitions and after clinic or discharge letters. |
Reconciliation record, document workflow. |
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3. Patient Group Directions
| Check |
Evidence to review |
Status |
Action owner |
Due date |
| Each Patient Group Direction in use is current and within its review period. |
PGD register, review dates. |
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| Each PGD is signed by a doctor (or dentist) and a pharmacist, and authorised by the organisation (Human Medicines Regulations 2012). |
Signed PGD documents. |
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| Only named, registered professionals assessed competent for that PGD use it, and the service holds the authorised-user list. |
Authorised-user list, competency record. |
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| PGDs are used only within their defined clinical scope; a Patient Specific Direction is used where a PGD does not apply. |
PGD scope, PSD records. |
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4. High-risk and monitored medicines
| Check |
Evidence to review |
Status |
Action owner |
Due date |
| High-risk and monitored medicines (for example methotrexate and other DMARDs, anticoagulants, lithium, amiodarone) have monitoring tracked against a shared-care or local protocol. |
Monitoring record, blood-test results, protocol. |
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| Overdue monitoring is identified and acted on before the next issue. |
Overdue-monitoring search, action record. |
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| Shared-care agreements are in place and accepted where prescribing is shared with secondary care. |
Shared-care agreement, correspondence. |
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| Once-weekly or narrow-margin medicines (for example methotrexate) have specific safety controls. |
Prescribing setup, safety alert evidence. |
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5. Controlled drugs
| Check |
Evidence to review |
Status |
Action owner |
Due date |
| Controlled drugs are prescribed within the Misuse of Drugs Regulations, and private controlled-drug prescriptions use the correct form with the required particulars. |
Prescription sample, procedure. |
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| Controlled-drug stock held on site is stored in a controlled-drugs cabinet meeting safe custody, recorded in a register with a running balance, and reconciled. |
CD register, cabinet check, balance check. |
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| Controlled-drug standard operating procedures cover ordering, receipt, storage, administration, incidents, disposal and records. |
CD SOPs. |
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| Disposal or denaturing of controlled drugs is witnessed by a person authorised by the NHS England Accountable Officer, and recorded. |
Disposal record, authorised-witness evidence. |
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| The service knows whether any of its activities need a Home Office controlled-drug licence (routine prescribing and administering do not; producing, supplying or wholesaling controlled drugs does). |
Activity review, licence record where applicable. |
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6. Antimicrobial stewardship
| Check |
Evidence to review |
Status |
Action owner |
Due date |
| Antibiotic prescribing follows local and NICE guidance, using first-line agents and durations unless a documented reason applies. |
Prescribing guidance, records. |
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| The service runs antibiotic prescribing audits and reviews its prescribing data (for example using the TARGET toolkit). |
Audit, prescribing-data report. |
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| Delayed or back-up prescribing is used where appropriate, with self-care advice given. |
Records, patient information. |
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| Antimicrobial stewardship links to the service's infection prevention and control work. |
IPC link, stewardship record. |
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7. Storage, stock and cold chain
| Check |
Evidence to review |
Status |
Action owner |
Due date |
| Stock medicines and vaccines are stored securely and at the correct temperature. |
Storage check, stock procedure. |
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| Fridge and cold-chain medicines have temperature records with escalation when out of range. |
Fridge log, incident record, cold-chain checklist. |
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| Emergency medicines and equipment are in date and checked at a stated frequency. |
Emergency-drugs check log. |
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| Expiry checks are completed and acted on, and returns and disposal are recorded. |
Expiry audit, disposal record. |
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8. Safety, incidents and audit
| Check |
Evidence to review |
Status |
Action owner |
Due date |
| Medicines safety alerts and drug recalls are logged, assessed and closed with evidence. |
Alert log, action evidence. |
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| Medicines and prescribing incidents and significant events are reported, reviewed for themes, and learning is shared. |
Incident sample, significant-event review. |
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| Harm, duty of candour, safeguarding and CQC statutory notification decisions are considered. |
Linked records, decision notes. |
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| A pharmacist-led or pharmacy-supported prescribing audit runs at a stated cadence, and opioid and other high-risk prescribing is reviewed. |
Audit schedule, completed audits. |
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| Medicines risks are on the risk register, and overdue actions are reviewed at governance. |
Risk register, governance minutes. |
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9. Summary judgement
| Question |
Answer |
| Which medicines process carries the highest current risk? |
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| Which medicines record has the weakest evidence trail? |
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| Which prescribing or monitoring theme repeated in the last 12 months? |
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| Which action or audit finding is overdue? |
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| What would a CQC inspector see if they asked for medicines evidence today? |
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10. Action log
| Action |
Source check |
Owner |
Due date |
Completion evidence |
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11. Completion
| Sign-off |
Name |
Date |
| Completed by |
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| Reviewed by medicines or prescribing lead |
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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.