Medicines and controlled drugs policy

1. What the regulation says

Each designated body must nominate or appoint, or in a group with one or more other designated bodies must jointly nominate or appoint, a fit, proper and suitably experienced person to be its accountable officer.

An accountable officer of a provider body must establish and operate, or ensure that the provider body or each member of the group of provider bodies establishes and operates, appropriate arrangements for securing the safe management and use of controlled drugs, and review those arrangements as appropriate.

Up to date standard operating procedures in relation to the management and use of controlled drugs, which cover (amongst other matters) best practice relating to prescribing, supply, administration, and clinical monitoring.

CDAOs must ensure relevant individuals receive appropriate information, education, or training on the standard operating procedures.

Every person authorised by or under regulation 5 or 8 to supply any drug specified in Schedule 1 or 2 shall comply with the following requirements as to the keeping of records.

No person required to keep records under these Regulations shall destroy or cause to be destroyed any drug specified in Schedule 1 or 2 except in the presence of a person authorised (whether personally or as a member of a class) for the purposes of this paragraph by the Secretary of State.

An accountable officer (within the meaning of regulation 8 of the Controlled Drugs (Supervision of Management and Use) Regulations 2013) shall not be an authorised person for the purposes of paragraph (1).

The full text of the framework is at https://www.legislation.gov.uk/uksi/2013/373/contents. Where this policy and the live regulations diverge, the live regulations win.

2. Plain British summary

Medicines management for healthcare providers sits across 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 1-5 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.

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.

(Tenant updates the angle-bracket placeholder.)

4. Roles and responsibilities

• Registered Manager: accountable for the medicines management system operating across every site. Reviews every medicines-related incident at moderate harm or above. 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.

(Tenant updates the named role-holders.)

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, 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 (error in prescribing, supply, administration, near miss) is logged the same shift through the incident reporting policy. The Reg 18 (Registration Regulations 2009) notification check runs at log-time; serious medicines incidents may meet the trigger.
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 Section 7 below and presents at the monthly clinical governance committee.

6. Training requirement

• 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.
• 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.

7. 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.

8. 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.

9. Related policies in this pack

• Safe Care and Treatment Policy (hscra-reg-12-safe-care-and-treatment)
• Infection Prevention and Control Policy (ipc-code-of-practice)
• Good Governance Policy (hscra-reg-17-good-governance)
• Statutory Notifications Policy (cqc-reg-18-notification-of-other-incidents)

10. Document control

This sample policy template was issued by Verivius as part of the Mock Inspection design partner onboarding pack. It is a template, not a substitute for legal advice or the tenant's own policy-development process. Where this template and the live regulation diverge, the live regulation wins.