Controlled drugs

19.1     The Misuse of Drugs Act 1971 places controls on certain prescribed medications (known as controlled drugs) because of their potential for misuse. The Misuse of Drugs Regulations 2001 and The Misuse of Drugs (Safe Custody) Regulations 1973 categorise controlled drugs into five schedules and specify the different legal requirements for how controlled drugs must be stored and for record keeping apply to each schedule. To meet our legal obligations, we must:

• securely store all controlled drugs listed in Schedule 2 of the 2001 Regulations and certain controlled drugs in Schedule 3 as set out in paragraphs 19.8 – 19.10. 
• record the receipt, administration and disposal of Schedule 2 controlled drugs in the controlled drugs register in addition to all other records required by this policy and local procedures. 

19.2    This section sets out the council’s requirements for all medication in Schedule 2 and medication in schedule 3 to which legal requirements apply.
 

Identifying controlled drugs when they are received

19.3    Staff who receive medications from any source are responsible for checking whether or not the medication is a controlled drug.  Any community pharmacy will be able to help identify controlled drugs and advise about storage and recording requirements. Reliable online information can be found at Online BNF (Adults); Online BNF for Children;  GOV.UK common controlled drugs list; CQC guidance (controlled drugs in care homes). 

19.4    Checking whether a medication is a controlled drug must be undertaken when someone first enters a service, or when there has been a medication change.

19.5    When a medication is identified as a controlled drug, staff must:

• check which schedule applies to the medication
• record the receipt of medications in Schedule 2 in the controlled drugs register 
• ensure that medication in schedule 2 and medication in schedule 3 to which legal requirements apply are stored as set out in paragraphs 19.8 – 19.10.

Double staff involvement – controlled drugs register and the MAR

19.6    Two staff must be involved in updating the controlled drugs register and the MAR whenever Schedule 2 controlled drugs are received, administered, disposed of and stock balances checked. 

19.7    One staff member must carry out and record the activity then sign and date the record. The second staff member must check that everything is correct and countersign the record.

Storage requirements for controlled drugs 

19.8    Access to controlled drug storage areas will be restricted according to need.  Risk assessments will be used to decide who may hold keys.

19.9    Adult services must store all schedule 2 controlled drugs and those schedule 3 controlled drugs to which secure storage requirements apply:

• in a dedicated controlled drugs cupboard which meets the requirements of the Misuse of Drugs (Safe Custody) Regulations 1973 (safe custody regulation), or
• in a separate container in a safe which complies with the safe custody regulation, or 
• in a locked box separate from other medications in a standard locked medicines refrigerator if the medication requires refrigeration. 

19.10    Children’s homes are not subject to the safe custody regulation. Controlled drugs will be stored in a locked internal cabinet in a locked medication cabinet secured to the wall within a locked medication room or in a locked container in a refrigerator within a locked room if the medication requires refrigeration.

 
People who manage their own medication:

19.11    People who are using controlled drugs and manage their own medication are not subject to the safe custody regulation. Decisions about safe storage of controlled drugs managed by someone using the service will be based on risk assessment and recorded on the person’s plan. The storage place must not be accessible to other people. This could be a lockable cupboard or drawer in their room.

Missing stock

19.12    If controlled drugs (schedule 2, 3, 4 and 5 The Misuse of Drugs Regulations 2001 go missing, the following reporting routes must be followed:
 

Controlled Drugs Accountable Officer (CDAO) / NHS England
 

19.13    All incidents involving missing, lost, stolen, given in error or unaccounted-for controlled drugs - including near misses - must be reported to your local NHS England Controlled Drugs Accountable Officer via the CD Reporting platform (www.cdreporting.co.uk). 

19.14    Reports should ideally be submitted within 48 hours, particularly for high-risk incidents (e.g., potential diversion, patient harm, theft). Typically, a fuller investigation report should follow within 28 days.
 

Police (if criminal activity is suspected)
 

19.15    If the missing drugs are potentially the result of theft or other criminal activity, you must also report the incident to the Police - calling 999 in emergencies or 101 otherwise.

 
Home Office – DFLU Form (for thefts or losses)

19.16    Statutory notification of theft or unaccounted loss of controlled drugs must be made using the Home Office "Notification of theft/unaccounted loss" form, submitted to the Drugs and Firearms Licensing Unit (DFLU). 

Care Quality Commission (CQC) [Regulated provision only]

 
19.17    In care homes and similar regulated adult social care settings, a missing controlled drug may meet the threshold for a statutory Care Quality Commission (CQC) notification, especially if it could affect service safety or indicates a serious issue (e.g., theft, abuse, serious error).
 

Internal and Additional Reporting

19.18    The incident must also be reported to the councils Safety, Health and Environment (SHE) team, and to Head of Service to allow for essential internal investigation. All council’s policies must be followed, for example safeguarding policies.
 

Summary of reporting: