1. Purpose
This policy sets out how the Service orders, stores, carries, administers, records, checks and disposes of controlled drugs and other medicines carried on ambulance vehicles.
The Service must verify this policy against current Misuse of Drugs Act, Misuse of Drugs Regulations, Controlled Drugs Supervision of Management and Use Regulations, Home Office, CQC and NHS England controlled-drug source material before adoption.
2. Sources to verify before adoption
- 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
- Controlled Drugs (Supervision of Management and Use) Regulations 2013: https://www.legislation.gov.uk/uksi/2013/373/contents
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12: https://www.legislation.gov.uk/uksi/2014/2936/regulation/12
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 17: https://www.legislation.gov.uk/uksi/2014/2936/regulation/17
- CQC, controlled drugs guidance: https://www.cqc.org.uk/guidance-regulation/controlled-drugs
- CQC, Home Office controlled drugs licences: https://www.cqc.org.uk/guidance-regulation/controlled-drugs/home-office-controlled-drugs-licences
- GOV.UK, controlled drugs list: https://www.gov.uk/government/publications/controlled-drugs-list--2
- NHS England, controlled drugs accountable officer information: https://www.england.nhs.uk/contact-us/privacy-notice/how-we-use-your-information/safety-and-quality/controlled-drugs-accountable-officer-alerts-etc/
3. Scope
This policy applies to:
- controlled drugs held as Service stock
- controlled drugs carried on vehicles
- patients' own controlled drugs carried during transport
- other medicines carried on vehicles, including oxygen and emergency medicines where the Service uses them
- medicine bags, pouches, lockers, safes and vehicle storage
- ordering, receipt, issue, administration, return and disposal
- stock discrepancies, breakages, losses, thefts and suspected diversion
- crew members authorised to handle, administer or check medicines
This policy does not permit any medicine or controlled drug to be held, transported or administered unless the Service has the legal authority, governance approval, prescription, patient-specific direction or other lawful route required for that medicine.
4. Medicines governance framework
The Service keeps a medicines governance framework for every medicine and controlled drug it carries.
4.1 Approved medicines list
The Lead Clinician maintains an approved medicines list.
The list records:
- medicine name
- formulation and strength
- whether the medicine is a controlled drug
- legal classification and schedule where applicable
- route by which the Service can lawfully hold or administer it
- crew role authorised to handle or administer it
- training and competency needed
- storage requirement
- vehicle or bag where it may be carried
- expiry-check process
- incident escalation route
Staff do not use an old printed list as authority to hold or use a medicine. The Lead Clinician verifies the list against current source material before approval and at review.
4.2 Ordering and receipt
The Service orders medicines only through approved suppliers and lawful routes.
The receipt record includes:
- medicine received
- quantity
- batch number where available
- expiry date
- supplier
- date and time received
- person receiving
- second checker where the local process requires it
- storage location
Controlled-drug receipt is recorded in the controlled-drug register where the current source material requires it.
4.3 Vehicle issue and return
The Service records medicines issued to each vehicle or crew bag.
The record includes:
- vehicle or bag identifier
- date and time issued
- quantity issued
- seal number where used
- staff member issuing
- crew member receiving
- end-of-shift return count
- discrepancy or breakage
Controlled-drug stock checks are completed at vehicle handover or shift handover according to the Service's current local procedure.
4.4 Storage and security
The Service stores medicines securely at the operating base and on vehicles.
The local procedure covers:
- who can access stock
- key or code control
- vehicle storage location
- temperature or environmental control where required
- segregation of expired, damaged or recalled stock
- arrangements when a vehicle is off base
- response to lost keys, damaged locks or broken seals
The Service checks whether a Home Office controlled-drugs licence is required before holding stock. The policy does not treat patients' own medicines and Service stock as the same category.
5. Administration, recording and patient medicines
Crew administer medicines only where the role, competency, legal route and clinical indication allow it.
The administration record includes:
- patient identity
- medicine name
- dose
- route
- date and time
- clinical indication
- crew member administering
- second checker or witness where required
- effect, refusal or adverse reaction where relevant
- remaining stock balance where required
Patients' own medicines travel with the patient only where the journey plan or referring service requires it. Crew record medicines handed over at destination and do not use a patient's own controlled drug for another patient.
6. Discrepancy, loss, theft, breakage and disposal
6.1 Controlled-drug discrepancy
If Staff identify a controlled-drug discrepancy, they record an incident immediately.
The Registered Manager and Lead Clinician:
- make any patient safe
- secure remaining stock
- preserve records, seals, bags and vehicle storage where relevant
- check the last verified balance
- identify staff and vehicles involved
- check whether administration, transfer, breakage or documentation explains the discrepancy
- consider whether the regional NHS England controlled drugs accountable officer, Home Office, police, commissioner or CQC notification advice is needed
- record the decision and rationale
- assign improvement actions
The Service does not wait for the next audit to investigate a controlled-drug discrepancy.
6.2 Loss, theft or suspected diversion
If loss, theft or suspected diversion is identified, the Registered Manager escalates promptly.
The escalation record includes:
- substance or medicine involved
- quantity
- schedule where applicable
- vehicle, bag or base location
- immediate safety action
- staff involved
- external advice sought
- reporting decision
- return-to-duty or restriction decision where staff conduct is under review
Where criminal activity may be involved, the Service considers police contact and preserves evidence.
6.3 Breakage, expiry and disposal
The Service records breakage, expiry and disposal according to the current source material and local procedure.
The record includes:
- medicine
- quantity
- reason for disposal
- date
- person disposing
- witness or authorised witness where current source material requires it
- destination or disposal route
Staff do not restate controlled-drug disposal rules from memory. They check the current legal source and local accountable-officer route before disposal.
7. Responsibilities
- Registered Manager: owns this policy, ensures medicines governance is in place and signs off annual review.
- Lead Clinician: owns the approved medicines list, clinical competency, JRCALC alignment and clinical escalation.
- Operations Manager: ensures medicines checks fit vehicle allocation, rota and handover arrangements.
- Controlled Drugs Lead or Medicines Lead: maintains controlled-drug records, stock checks, discrepancy review and accountable-officer contact routes where appointed.
- Crew: handle and administer medicines only within role, competency, legal route and local procedure.
- All staff: report discrepancies, damaged stock, missing records, broken seals and unsafe storage immediately.
8. Recording requirements
The Service keeps the following records:
- approved medicines list
- controlled-drug register where required
- vehicle or bag stock record
- issue and return record
- administration record
- medicine expiry check
- storage and security check
- temperature record where required
- discrepancy, loss, theft, breakage or disposal record
- external advice and notification decision
- staff training and competency record
- improvement action record
Records are kept in the Service governance records and are available for internal review, CQC review, accountable-officer review, commissioner review and external review where required.
9. Audit cadence
The Service uses the following Verivius default audit rhythm unless current MDA, MDR, CDSMUR, Home Office, CQC, commissioner or local source material requires a different rhythm:
- Per shift handover: Crew check controlled-drug stock where the vehicle or bag carries controlled drugs.
- Weekly: the Controlled Drugs Lead or Medicines Lead reviews vehicle stock records, missing entries, expired stock and open discrepancies.
- Monthly: the Lead Clinician reviews medicine incidents, administration records and competency gaps.
- Quarterly: the Registered Manager reviews controlled-drug governance, accountable-officer advice, external reporting decisions and improvement actions.
- Annually: the Service audits this policy against current source material and updates the approved medicines list.
Audit findings are recorded as improvement actions with an owner and review date.
10. Version control and review date
The Service keeps a controlled copy of this policy. The footer or document-control table records:
- policy owner
- version number
- date approved
- next review date
- changes made since the last version
- source material checked during the review
11. Related records
- Approved medicines list
- Controlled-drug register
- Vehicle stock record
- Medicine administration record
- Training matrix
- Crew clinical scope and JRCALC competency policy
- Vehicle defect, MOT and roadworthiness policy
- Incident register
- Duty of candour policy
- Risk register
- Improvement action register
Review cadence: annual or on regulatory change, whichever sooner. Owner: Registered Manager.