CQC medication policy template

1. What the regulation says

Care and treatment must be provided in a safe way for service users. (Reg 12(1) (the headline duty))

assessing the risks to the health and safety of service users of receiving the care or treatment, (Reg 12(2)(a) (risk assessment))

doing all that is reasonably practicable to mitigate any such risks, (Reg 12(2)(b) (risk mitigation))

where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs, (Reg 12(2)(f) (sufficient equipment + medicines supply))

the proper and safe management of medicines, (Reg 12(2)(g) (medicines management))

The full text of the regulation is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/12. Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

Care and treatment must be provided in a safe way. The regulation lists the areas a provider must address, including risk assessment, risk mitigation, staff competence, safe premises, safe equipment, sufficient equipment and medicines, medicines safety, infection prevention and shared-care planning. Regulation 12 is central to CQC's safety expectations.

The proper and safe management of medicines under Regulation 12 is delivered through two parallel statutory tracks. The general medicines framework is in the Human Medicines Regulations 2012, which classifies medicines (Prescription-Only, Pharmacy, General Sale), specifies who can prescribe, supply and administer them, and sets record-keeping requirements. The controlled drugs framework is in the Misuse of Drugs Act 1971 plus the Misuse of Drugs Regulations 2001 (which set the Schedule 1 to 5 classifications, register, safe custody and destruction requirements) plus the Controlled Drugs (Supervision of Management and Use) Regulations 2013 (which establish the Accountable Officer role, mandatory standard operating procedures, and Local Intelligence Network participation). For independent secondary care, the load-bearing operational requirements are: a named Accountable Officer for Controlled Drugs (CDAO), current standard operating procedures covering prescribing, supply, administration and clinical monitoring, a properly maintained CD register, safe custody compliant with the Misuse of Drugs (Safe Custody) Regulations 1973, and witnessed destruction of CDs by an Authorised Witness who is not the Accountable Officer.

This page is the cross-sector starting point. If you run a care home, a domiciliary service, or a GP practice, use the sector-specific policy or audit pages linked near the end of this template.

3. Scope

This policy applies to all staff at who prescribe, supply, administer, store, transport, or dispose of medicines or controlled drugs, plus the Accountable Officer for Controlled Drugs (CDAO) where the role exists. It covers prescription-only medicines, pharmacy medicines, general-sale medicines, every Misuse of Drugs Schedule 1 to 5 controlled drug stocked or handled at any site, the CD register, the CD safe and any other safe-custody location, and the standard operating procedures (SOPs) covering prescribing, supply, administration, and clinical monitoring.

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4. Roles and responsibilities

• Registered Manager: accountable for the medicines management system operating across every site. Reviews every medicines-related incident involving significant actual or potential harm, using the service's local incident severity taxonomy. Signs off the quarterly medicines audit.
• Nominated Individual: holds provider-side accountability.
• Controlled Drugs Accountable Officer (CDAO; where the role applies): named individual fit, proper, and suitably experienced per the Controlled Drugs (Supervision of Management and Use) Regulations 2013. Establishes and maintains the SOPs, ensures training, participates in the Local Intelligence Network, takes responsibility for the safe-management arrangements. Cannot be the same person as an Authorised Witness for CD destruction.
• Authorised Witness for CD destruction: a separate named person from the CDAO, authorised by the Secretary of State for the destruction-witnessing role.
• Medicines Management Lead (where the CDAO role does not apply; usually a senior nurse or pharmacist): the day-to-day medicines authority. Operates the audit programme, manages stock and expiry, advises on prescribing-supply-administration questions.
• All prescribing clinicians: prescribe within their professional scope and per the local formulary; record indications, doses, durations.
• All staff who administer or supply medicines: follow the relevant SOP, record the administration in the medicines record, escalate any error the same shift.

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5. Procedure

The medicines management procedure operationalises the prescribing-supply-administration-disposal chain.

1. Prescribing. Prescribers prescribe within their professional scope, per the local formulary, and in line with relevant NICE guidance (for example NG5 on medicines optimisation, and NG67 on managing medicines for adults receiving social care in the community where it applies), with indication, dose, frequency, duration, and review point recorded. Electronic prescribing is used where available; paper prescriptions follow the legal-format requirements of the Human Medicines Regulations 2012.
2. Supply and stock. Medicines are obtained from authorised wholesalers or pharmacies. Stock is held within the licensed conditions (temperature-monitored where required for cold-chain). Stock checks against the medicines register run weekly; near-expiry stock is flagged and used or disposed of per the disposal procedure.
3. Controlled drugs storage. CDs in Schedules 2 and 3 (where they require safe custody under the Misuse of Drugs (Safe Custody) Regulations 1973) are held in a compliant CD cabinet (BS 2881 spec). The CD cabinet is in a defined location, locked, with key control limiting access to authorised staff.
4. Controlled drugs register. Every receipt, supply, administration, and disposal of a Schedule 1 or 2 CD is recorded in the CD register at the time of the action. The register entries include date, name and quantity, person to whom supplied or by whom administered, the receiver or witness, balance running total. The register is bound and rules-line ruled; electronic CD registers are accepted only where they meet the Home Office requirements.
5. Administration. Administration follows the local SOP and the relevant clinical guideline. The Five Rights (right patient, right drug, right dose, right route, right time) are checked at the point of administration. Documented immediately; administration record forms part of the clinical record.
6. CD destruction. CDs that need to be destroyed (expired, contaminated, returned by patient) are destroyed in the presence of an Authorised Witness who is not the CDAO. The destruction is recorded in the CD register and on the destruction log.
7. Incident reporting. Any medicines-related incident, including an error in prescribing, supply or administration, a missed or omitted dose, and a medicine the person refused, is logged the same shift through the incident reporting policy. The service checks whether the person came to harm and gets medical help where needed. The Reg 18 (Registration Regulations 2009) notification check runs at log-time; serious medicines incidents may meet the trigger. Medicines incidents are reviewed together to find patterns, not treated as a single worker's fault.
8. Patient self-administration (where applicable). Where the service supports patient self-administration, a self-administration risk assessment is recorded, the medication is held in a patient-specific lockable cabinet, and the self-administration record runs alongside the clinical record.
9. Medicines reconciliation. At every patient transition (admission, transfer, discharge), the medicines list is reconciled against the prescribing record and any changes are documented. Reconciliation is a clinical step, not an administrative one.
10. Quarterly audit and pattern review. The Medicines Management Lead or CDAO runs the audit per the audit section below and presents at the monthly clinical governance committee.

6. Assessing medication needs, consent and the level of support

Before the service supports a person with medicines, it assesses what support they need and secures consent:

• the service assesses each person's medication needs, what they can do for themselves, and the support they need, and records it in the care plan
• consent to medicines support is sought; where a person aged 16 or over may lack capacity for a medicines decision, the service follows the Mental Capacity Act and makes a best-interests decision (see the consent policy)
• the service records the level of support for each medicine, and reviews it when needs change. The recognised levels are prompting and reminding (the person manages their own medicines and is reminded), assisting (the person directs their medicines but needs practical help, for example opening a container), and administering (a worker selects, prepares, gives and records the medicine)
• where the service supports medicines in a person's own home, it agrees with the person how and where their medicines are stored, and records that agreement

7. Specific administration situations

The service has clear arrangements for situations that carry extra risk:

• Covert administration: giving medicine without a person's knowledge (for example hidden in food) is only ever considered where the person lacks capacity for that decision; it requires a recorded capacity assessment, a best-interests decision involving the prescriber and pharmacist, and a method agreed with the pharmacist. A worker never decides this alone.
• When-required (PRN) medicines: each PRN medicine has a protocol covering what it is for, the signs it is needed, the dose and the maximum in a day, and how a person who cannot ask in words shows they need it; each dose given is recorded with the reason.
• Sharps and injectable medicines: sharps are used and disposed of safely (see the infection prevention and control policy), and injectable medicines are given only by competent, trained staff.
• Medical gases: where the service uses medical gases such as oxygen, they are stored, handled and given safely per the supplier and clinical guidance.
• Delegated healthcare tasks: a medicines-related task is delegated only by a competent registered professional, to a worker assessed as competent for that specific task, with clear instructions and review.
• The Medication Administration Record (MAR): where the service administers or assists with medicines, an accurate MAR is kept; each administration, and the reason any dose was not given (including a refusal or an omission), is recorded and signed at the time, and MAR governance is audited (see the audit section).
• Stopping over-medication (STOMP and STAMP): for people with a learning disability or autism, the service supports the STOMP and STAMP aims to stop the inappropriate use of psychotropic medicines, and works with prescribers to review and reduce them where it is safe to do so.

8. Training and competency

• All staff who handle medicines complete medicines management awareness at induction and annually.
• All prescribers complete prescribing-related training as required by their professional regulator (GMC, NMC for prescribing nurses, GPhC, etc.) plus the local formulary induction at appointment.
• The CDAO completes CDAO-specific training at appointment and refresher annually; familiarity with the Local Intelligence Network and the destruction protocols is mandatory.
• All staff who administer medicines complete administration training (Five Rights, the local administration SOP) at induction and annually.
• Staff who administer or assist with medicines are assessed as competent in practice before doing so unsupervised; competence is re-checked on a stated cadence and after any concern, and a worker is removed from medicines tasks until a concern is resolved.
• The Medicines Management Lead and any pharmacist on staff complete continuing professional development as their professional regulator requires.

Training records held in the tenant's training matrix register.

9. Audit

Compliance with this policy is monitored by the Medicines Management Lead or CDAO:

• Weekly stock check: every controlled drugs cabinet's running balance reconciled to the CD register; any discrepancy investigated the same shift.
• Monthly expiry audit: stock checked against expiry dates; near-expiry items flagged and used or disposed of per the disposal procedure.
• Quarterly medicines audit: sample of prescribing records, administration records, and reconciliation records reviewed against the local SOPs; CD register reviewed end-to-end; safe-custody location inspected; key control reviewed.
• Annual CDAO report (where applicable): submitted per the Controlled Drugs (Supervision of Management and Use) Regulations 2013 obligations.

Audit findings recorded in the tenant's audit register; actions logged in the improvement-actions register.

10. Record-keeping

Medicines records (prescribing, supply, administration, reconciliation) form part of the clinical record and are held for a minimum of 8 years from the date of the last entry per the NHS Code of Practice on Records Management.

Controlled drugs registers are held for a minimum of 2 years from the date of the last entry per the Misuse of Drugs Regulations 2001, regulation 19(1)(a). Most providers retain CD registers for 7 years aligned to clinical-record retention.

Patient-specific medication charts, destruction logs, and any incident records arising from medicines are retained per the source-record retention.

Verivius preserves the per-record audit trail indefinitely while the workspace is active.

11. Sector-specific medicines pages and related policies

• Article: CQC controlled drugs 2025: evidence for providers
• Sector policy: Care home medication policy template (adult social care)
• Sector policy: Domiciliary care medication support policy template
• Sector policy: GP safe prescribing and high-risk medicines policy template
• Sector checklist: Care home medicines audit checklist
• Sector checklist: Primary care prescribing and medicines audit checklist
• Related policy: Safe care and treatment policy template
• Related policy: Consent policy template
• Related policy: Infection prevention and control policy template
• Related policy: Good governance policy template
• Related policy: CQC statutory notifications policy template

12. Sources and further reading

This template is based on CQC's guidance for providers and managers, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and other topic-specific legislation and guidance listed below. It is a starting point for adaptation, not a substitute for legal, clinical, HR, safeguarding or specialist professional advice.

• CQC Regulation 12: Safe care and treatment
• NICE medicines guidance (including NG5 medicines optimisation and NG67 managing medicines for adults receiving social care in the community)
• CQC medicines optimisation guidance
• MHRA alerts
• Human Medicines Regulations 2012 (https://www.legislation.gov.uk/uksi/2012/1916/contents)
• Misuse of Drugs Act 1971 (https://www.legislation.gov.uk/ukpga/1971/38/contents)
• Misuse of Drugs Regulations 2001 (https://www.legislation.gov.uk/uksi/2001/3998/contents)
• Misuse of Drugs (Safe Custody) Regulations 1973 (https://www.legislation.gov.uk/uksi/1973/798/contents)
• Controlled Drugs (Supervision of Management and Use) Regulations 2013 (https://www.legislation.gov.uk/uksi/2013/373/contents)
• NHS England controlled drugs accountable officer guidance (where applicable)
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/12)

13. When to seek further advice

Seek specialist advice where the issue involves serious harm, safeguarding, deprivation of liberty, restraint, children, professional misconduct, controlled drugs, radiation, termination of pregnancy, infection outbreak, water safety, employment dismissal, DBS barring referral, or regulatory enforcement.

14. Document control

This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the tenant's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.